FEASIBILITY
           OF AN
EPA CERTIFICATION PROGRAM

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                                FEASIBILITY
                                    OF AN
                         EPA CERTIFICATION PROGRAM
                  By

             D. M. Speaker
          J. C. Fensterstock
             A.'- H. Ma her
        Contract No. 68-03-2012
      Program Element No.
            Project Officer

             Paul Britton
National Environmental Research Center
           Cincinnati, Ohio
             Prepared for
  OFFICE OF RESEARCH AND DEVELOPMENT
 U.  S. ENVIRONMENTAL PROTECTION AGENCY
        WASHINGTON, D.C.  20460

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              FEASIBILITY OF AN EPA CERTIFICATION PROGRAM

                           EXECUTIVE SUMMARY

This study, which was sponsored by the Methods Development and Quality
Assurance Research Laboratory of the U.S. Environmental Protection
Agency, explored the possible certification of environmental monitoring
laboratories as a means for assuring that the quality and reliability
of data generated by them would meet at least minimum levels of
acceptability.  A clear distinction is made between the formal and ad-
ministrative aspects of the certification process and the technical
evaluatory procedures through which laboratory eligibility would be
established.  It is recommended that laboratory evaluation be conducted
by EPA's Quality Assurance organization.   It is believed that the cur-
rent QA Inter-laboratory Program, if appropriately expanded and provided
with sufficient resources, could, in conjunction with the NERCs, adequate-
ly fulfill the evaluatory function.  It is also recommended that responsi-
bility for program formalities, including certification decision making,
be vested in a new EPA element which would be organizationally separate
from the QA organization.

During the early phases of the study, various on-going laboratory
certification programs were examined.  These programs, operated by
Federal, State and private organizations, related to various types of
laboratory activity (clinical, milk, water, etc.).  In virtually all
cases, however, the same elements were found to occur as the bases
for laboratory certification or accreditation.  These elements are:

     .  Laboratory facility evaluation, based on direct inspection.

     .  Assessment of personnel credentials in terms of established
        criteria for training and experience.

     .  Evaluation of laboratory performance through proficiency
        testing.  (Results of analyses of test samples are compared
        with target values.)

The principal objective of the certification program survey, which
included on-site visits to accrediting organizations and to laboratories
approved under their programs, was to elicit factual information and
viewpoints which might be helpful in the development of a plan for
EPA consideration.  A key finding was that, in most instances, certifi-
cation programs were strongly influential in upgrading the quality and
reliability of laboratory data.  The proficiency testing component of

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 these programs was usually cited as the prime factor because it enables
 the laboratories to pinpoint specific areas of deficiency and institute
 remedial action.

 The study also included an analysis of various important issues relating
 to structural and procedural aspects of an EPA certification program.
 The principal conclusions are:

     .  EPA should operate a certification program directly, rather
        than as a contracted service.

     .  Responsibility for procedural aspects of the formal certifi-
        cation process should be vested in a central EPA entity
        established for this purpose.

     .  Responsibility for all standard setting, evaluatory and other
        technical support functions should be assumed by the Quality
        Assurance program staff.

     .  Certification should be conducted on an integrated (cross-
        programmatic) basis, rather than implemented by separate
        certifying entities for the different EPA programs (air, water,
        pesticides, etc.).

     .  EPA should certify only to the State level, with State agencies
        assuming responsibility for approving intra-state laboratories.

     .  EPA should not attempt to institute laboratory certification in
        all programs simultaneously, but should first address water
        analysis laboratories (the need is judged to be greatest in this
        area), then air laboratories, then radiation laboratories and
        ultimately, possibly, pesticide laboratories.

     .  EPA should schedule State laboratory certification on a
        progressive basis, beginning with a small number of States
        already operating water laboratory licensing or approval pro-
        grams in addition to one State in which such a program does not
        now exist.

 An outline of a preferred certification program plan was formulated,
 reflecting the above conclusions as well as several more detailed
 recommendations.

The direct cost to EPA of establishing and operating a State  laboratory
certification program is believed to be moderate.   On the other hand,
 it appears certain that many State agencies will  require substantial
 funding support in order to establish and maintain  effective  environ-
mental  laboratory certification  programs.

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                                 ERA-
FEASIBILITY OF AN EPA CERTIFICATION PROGRAM
                    By

               D.  M. Speaker
            J. C.  Fensterstock
                A. M. Maher
          Contract No.  68-03-2012
        Program Element No.
              Project Officer

               Paul  Britton
  National  Environmental  Research Center
             Cincinnati,  Ohio
               Prepared for
    OFFICE OF RESEARCH AND DEVELOPMENT
   U.  S.  ENVIRONMENTAL PROTECTION  AGENCY
          WASHINGTON,  D.C.   20460

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                                CONTENTS

FOREWARD	
ABSTRACT	
CONTENTS	
ACKNOWLEDGEMENTS	
     I  CONCLUSIONS	     1
    II  RECOMMENDATIONS	     2
   III  INTRODUCTION	     3
    IV  STUDY FINDINGS	     9
        Phase I:  Preliminary Survey	     9
           Certification Program Reviews:  Methodology	     9
           Certification Program Reviews:  General Findings	    16
           Opinion Survey:  Methodology	    20
           Opinion Survey:  General Findings	    20
        Phase II:   In-depth Program Studies	    25
           Methodology	    25
           General Findings	    27
        Phase III:  Program Option Identification and
           Assessment	    50
           Methodology	    50
           Analysis	    52
        Phase IV:   Development of the Preferred Option	    66
           Methodology	    56
           General Considerations	    57
           Recommended Program	    75
     V  APPENDICES	    89
        Appendix I: Outlines of Certification Programs Reviewed	    89
           Introduction	    90

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                  CONTENTS  (continued)
   Federally Operated Certification Programs	    91

       HEW, Public Health Service, FDA, Bureau of Foods	    92
       USDA - Animal and Plant Health Inspection Service	    96
       HEW, Public Health Service, Center for Disease
          Control, Laboratory Licensure Section	    99
       DOL, Occupational Safety and Health Administration,
          Division of Safety Standards	   104
       HEW Social Security Administration, Bureau of
          Health  Insurance	   107
       EPA Water Quality Office, Water Supply Division	   m

   State Operated Certification Program	   114

       New York Department of Health, Division of
          Laboratories and Research	   <15
       Oklahoma Department of Health, Syphilis Serology
          Proficiency Testing Program	
       Oklahoma State Certification Program, Oklahoma
          Water Resources Board	   121
       Connecticut, State Department of Public Health	   123
       California, State Department of Public Health
          Water Laboratory Approval	   126
       California, State Department of Public Health,
          Clinical Laboratory Licensure	   '29

   Privately Operated Certification Programs	   132

       American Industrial  Hygiene Association	   133
       American Society of Clinical Pathologists  and
          College of American Pathologists	   13'

Appendix II: Examples of  Forms Used in Programs Reviewed	    142

   Introduction	   143
   HEW, FDA,  Bureau of Foods	   144
   HEW, PHS,  Center for Disease Control	
   State of New York	
   State of Connecticut	
   State of Cal ifornia	
   American  Industrial  Hygiene Association	
   College of American  Pathologists	

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                                ABSTRACT

Certification or licensing of environmental  monitoring laboratories
by EPA was examined as a mechanism for assuring data conformity with
minimum acceptable standards of quality and  reliability.   Various
on-going laboratory certification programs conducted by Federal,
State and private organizations were reviewed in a preliminary survey.
A recommended program was developed for EPA's consideration under which
the Agency would certify or license State environmental  laboratories,
with the States then certifying intrastate laboratories,  using Federally
established criteria.  Legislative authorization for this program is
considered a pre-requisite.  EPA's direct role in the certification
process which would operate as an adjunct to its current Quality
Assurance interlaboratory program, is not believed to entail  excessive
costs.  Many States, however, would require  substantial  supplementary
funding support for establishing and operating their programs.

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                            ACKNOWLEDGEMENTS

The authors wish to acknowledge the cooperation received from the many
officials associated with Federal, State and private organizations who
provided information during the performance of this study.  Specific
thanks are extended to the following for their help:

      Environmental Protection Agency

         Paul Britton, National Environmental Research Center,
            Cincinnati, Ohio
         Thomas W. Stanley, Quality Assurance Division, Washington, D.C.
         Headquarter and Regional Office Staffs

      Officials associated with the laboratory certification programs
         reviewed in this study and staffs of the laboratories operating
         under these programs.

The authors also wish to express their appreciation of the contributions
of Ira Blei and Arnold Greenberg to this study in providing guidance and
advice and in performing reviews of some of the certification programs
discussed in this report.

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                      I  CONCLUSIONS

Surveys of several existing analytical and testing laboratory
certification programs conducted by Federal, State and private
organizations showed an essentially similar structure, regard-
less of the areas of technical involvement.  Typically this
structure includes the following key elements:  facility in-
spection and evaluation, personnel qualification based on ex-
perience and/or training and laboratory performance assessment
by proficiency testing.

Most certifying organizations and the laboratories operating
under their programs agreed that the laboratory qualification
process, based on defined standards and criteria, substantially
improved the quality and reliability of the data produced.

The principal benefit to EPA of an environmental monitoring
laboratory certification program is that it would provide the
agency with a legal basis for refusing to accept data of un-
certain quality and reliability as might originate from un-
certified facilities.  Conversely, a laboratory certification
program would greatly enhance the probability that data gener-
ated by approved facilities would satisfy the Agency's minimum
reliability requirements.

A laboratory certification program operated by EPA should be
based on legislative authority and should directly license
only State laboratories, with the responsibility for the cer-
tification of intra-state laboratories borne by State agencies.
Further, while it would be desirable to certify all States si-
multaneously in all programmatic areas (air, water, etc.),it
may prove more feasible to initiate certification in one pro-
gram area and extend State coverage progressively until all
are included because of cost and other considerations.  One
possible approach is to initiate certification with selected
States on a voluntary, cooperative basis and subsequently to
make it mandatory for all States.

The cost of EPA program operations could approximate $750,000
annually for the certification of State water laboratories.
The total annual costs of State certification programs would
be considerably higher and the requirement for Federal support
of these programs through grants is viewed as inevitable.

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                    II RECOMMENDATIONS

EPA should examine both the strength of current legislative
authority and the prospects for obtaining explicit authority
for requiring environmental monitoring laboratory certifica-
tion prior to initiating a regulatory program.  It is also
recommended that the Agency consider the merits of an interim
voluntary program conducted on a cooperative basis with se-
lected States, even though this program would lack regulatory
force.

The formal and administrative components of a laboratory cer-
tification program should be regarded as separate from tech-
nical evaluatory activities directed to determing the poten-
tial capability and actual performance of a candidate labora-
tory.  It is recommended that responsibility for these activi-
ties, as well as the initial setting of criteria and standards
for laboratory qualification, reside with Quality Assurance
components of the Regional Offices and the NERCs.  It is also
recommended that a distinct administrative EPA element be es-
tablished for implementing the purely formal functions of the
certification program and that this entity be independent of
the Agency's Quality Assurance organization.

EPA should preferably certify State laboratories only, with the
States certifying intra-state laboratories.  EPA certification
of intra-state laboratories should occur only in event of de-
fault by the State.

The program should be addressed initially to water laboratories,
then to air laboratories and then to radiation ,and, possibly,
to pesticide laboratories.

The term "certification" is not recommended for several reasons.
It is suggested that State and other governmental laboratories
be "accredited" or "qualified" and that private laboratories
be "licensed."

Laboratories should be qualified or approved only for those
specific test or analytical categories within which their
ability to satisfy the program standards and criteria has been
established.

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                             Ill INTRODUCTION

The certification of environmental  monitoring laboratories has been pro-
posed as a possible mechanism for supporting the efforts of the U.S. En-
vironmental Protection Agency's data Quality Assurance (QA) program.  The
importance of this Program is difficult to overstate because the informa-
tion derived from environmental monitoring activities addressed to air
quality, water quality radiation and pesticide surveillance is pivotal to
most of EPA's decision making processes, to its assessments of progress
and trends in pollution abatement and to the implementation of its emis-
sion and effluent discharge control responsibilities.  The Agency's per-
formance is thus critically dependent on the quality (i.e., the accuracy
and reliability) of the environmental data which constitute its operating
information base.  It is therefore in no way incorrect to regard QA as co-
equal in importance with monitoring itself, rather than as a supplement
to this function.

An underlying data quality problem faced by EPA arises from the fact that
environmental monitoring, on the national scale, is  not wholly performed
by a single Federal agency controlling uniformly organized surveillence
operations.  In reality, a substantial proportion of monitoring functions
is delegated to State environmental agencies and disseminated  to local gov-
ernment and privately operated laboratories.  The range and variety of the
latter is quite broad.  For example, some private laboratories engaged in
water analysis are large, well equipped and well staffed establishments.
Others are little more than one- or two-man operations with severely limi-
ted facilities and resources.  This is not to imply that data  generated by
smaller laboratories are necessarily less reliable than those  developed by
larger organizations.  However, it is clear that the large number (in the
thousands) and diversity of environmental monitoring laboratories dictate
the need for a centrally administered and comprehensive QA program  in order
to ensure that, to the degree practicable, environmental data  received and
evaluated by EPA, regardless of their source, will meet defined reliability
criteria.  During the last few years the Agency has been developing a QA
program specifically designed to accomplish this objective.  While initially
addressed to the establishment of uniform quality assurance standards and
procedures through all EPA laboratories, it is now being extended to State
environmental monitoring agencies and  should ultimately include all par-
ticipating  analytical  laboratories,  both publicly  and  privately operated.


Although the preceding discussion, stressed the importance of  the QA role
in relation to analytical laboratory operations, it must be appreciated
that its application to other aspects of environmental sampling is  no less
important.  These include sample acquisition techniques (particularly in-
sofar as these may affect sample "representativeness") and also methods
for sample preservation which are designed to assure that its  chemical and
physical parameters have changed only minimally during the interval be-
tween collection and subsequent analyses.

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This study, whose broad purpose was the evaluation of environmental moni-
toring laboratory certification in terms of its feasibility and its po-
tential contribution to the support and advancement of EPA's QA interests,
was primarily oriented to policy considerations and the examination of pos-
sible modes of implementation as opposed to essentially technical factors.
Specific project objectives included an assessment of the probable benefits
and costs of certification as well as the formulation of various certifi-
cation program options.  During the course of the study, certain potential
problems were identified which could present obstacles to program estab-
lishment or could impair the effectiveness of its implementation.  Such
problems are discussed later in this report.  The study was performed in
successive phases as follows:

Phase I:  Preliminary Survey
Several on-going certification programs administered by Federal, State and
private organizations were examined in terms of processes, criteria and
other major characteristics.  These programs specifically related to the
certification of laboratories (as opposed to products, educational institu-
tions, etc.) in several areas of activity, such as clinical, drinking water
testing, and so forth.  In addition, numerous interviews were conducted
with EPA personnel, including those representing programmatic interests
(air and water pollution abatement) and those directly associated with QA
activities.

Phase II;  In-Depth Program Studies
Selected certification programs were examined in detail through visits
with officials responsible for their administration and through on-site
discussions at laboratories certified under these programs.  The purpose
of this phase of the study was to gain information and elicit opinions re-
garding the nature of any problems these programs had encountered, opera-
ting cost experience and benefits achieved.

Phase III:  Program Option Identification and Assessment
Various environmental monitoring laboratory certification program options
were identified and reviewed in terms of their advantages and disadvantages
from EPA's standpoint.  The overall certification process was initially sep-
arated into various major administrative and procedural elements and alter-
native approaches for each of these were then formulated.

Phase IV:  Development of Preferred Option
Using the analysis performed in Phase III as a basis, a preferred certi-
fication program option was developed for EPA's consideration.  This study
Phase included preparation of various procedural recommendations for pro-
gram establishment and implementation, as well as an identification of
prospective benefits of the program to the Agency.

The following discussion, which deals with certain conceptual aspects of
laboratory certification,  is intended to provide a background orientation

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which may be found particularly helpful to those with little direct asso-
ciation with the process.

In principle, the certification of an analytical or testing laboratory,
regardless of its specific functions, is the formal recognition by a quali-
fied evaluatory organization that the laboratory in question has satisfied
a set of established criteria relating to its capability and performance.
Accordingly, the data generated by a "certified" laboratory are presumed
to be more likely to meet defined standards of reliability and accuracy
than might be the case for an uncertified facility.  This consideration
is, in itself, the basis of EPA's interest in examining the certfication
of environmental monitoring laboratories as a mechanism which could con-
tribute to the attainment of its data quality objectives.

Virtually all laboratory certification processes are based on three cate-
gorical evaluatory elements whose specific details differ from program to
program, but whose fundamental character is invariant.  Of those, two re-
late to the assessment of the inherent capability of the laboratory being
appraised.  The third concerns actual laboratory performance.  In summary,
these elements are:

       a)  Facility Assessment
           Through on-site visits and, in many cases, through information
           previously submitted by the applicant laboratory, the certifying
           organization performs an evaluation of the candidate's facility
           in terms of both physical and functional parameters.  The for-
           mer usually include such factors as adequacy of laboratory space,
           general layout, equipment and the like.  Functional parameters
           may include not only the test and analytic methods routinely
           employed but also internal quality control procedures, such as
           details of sample handling and identification, instrument cali-
           bration frequency and the maintenance of an adequate and reli-
           able set of reference standards.

       b)  Personnel Assessment
           Professional and technical staff credentials often required as
           prerequisites to laboratory certification, are usually specifi-
           cally identified by the certifying organization.  These creden-
           tials typically reflect both education and experience and, under
           some programs, provide a basis for certifying a laboratory with
           respect to only certain categories of analysis and testing with-
           in its possible range of capability.

           It is important to recognize that a laboratory which has met the
           criteria of a certifying body with respect to the above assess-
           ment categories has, at that point, established only that it is
           potentially capable of acceptable performance.  Whether actual
           performance demonstrates this capability must still be determined.
           For this reason, certification processes necessarily include, as
           a third categorical element, some form of laboratory performance
           evaluation.

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      c)  Performance Testing
          The laboratory under evaluation is provided with test samples
          which it then analyzes, usually employing procedures which are
          either formally "approved" by the certifying organization or
          otherwise acceptable to it.  The differences between the results
          submitted by the laboratory and the "target" figures provide a
          measure of performance.  Although similar in basic purpose and
          principle, performance testing procedures conducted under dif-
          ferent certification programs vary considerably with respect to
          such details as the frequency of post-certification testing,
          the identification or non-identification of test samples as
          "unknowns", acceptability criteria and the degree to which the
          laboratory under review is informed of its performance with re-
          spect to other laboratories.

Most certifying organizations require recertification (or renewal of cer-
tification) of an approved laboratory either after some predetermined time
interval or after some major alteration in the laboratory condition (such
as removal to a new location or a significant change in staff) has occurred.
Typically, certification programs also provide for facility re-examination
and assessment as well as for repeated performance testing on a scheduled
basis during the period certification is in effect.

A central thesis of this study is the establishment of a clearcut division
of the overall  certification process into two distinct categories as fol-
lows:

       a)  Technical
           This category includes all technical  program elements and
           actions involved in or directly related to the evaluation of
           an applicant laboratory in terms of the adequacy of the fa-
           cility, its apparent capabilities and its demonstrated per-
           formance.   It also includes the setting of standards and cri-
           teria on which qualifications for certification are to be
           based as well as functions ancillary to evaluation such as
           the provision of reference samples.

       b)  Formal
           This category includes all administrative, legal  and regula-
           tory program elements and actions involved in or directly
           related to the formal implementation of the certification
           process.  Examples of such actions include: processing lab-
           oratory certification applications; assessing data and in-
           formation derived from laboratory facility and performance
           evaluation in terms of applicable standards and criteria;
           determining laboratory eligibility or no-eligibility for
           certification on the basis of this assessment; and imple-
           menting the formal certification of laboratories judged to
           be qualified.

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 The  considerations underlying this  distinction,  which  is  not commonly
stressed within most laboratory certification programs, are discussea
later in the report.  In general, they are based  on the fact that EPA's
QA activities already include the operation of an Inter-laboratory Qual-
ity Assurance Program which, although still in the early stages of its
development, could in the future provide all of the evaluative and other
technical functions appropriate to the technical  category (a) above.   Fur-
ther, for reasons which are presented later, it is recommended that,  while
the responsibility for all technical actions related to the certification
process (standard setting, facility evaluation, etc.) remains within  EPA's
Quality Assurance operation, responsibility for formal  and administrative
procedures (such as identified in (b) above) be vested in a new EPA or-
ganizational component which would be independent of the QA structure.

Although the term "certification" is used throughout this report as a mat-
ter of convenience, there are certain reservations about its appropriate-
ness as the official descriptor of an actual program, should one be imple-
mented by EPA.  A major reservation is that "certification" of a labora-
tory could be construed as meaning or implying that the "certifying"  en-
tity (EPA, in this case) in effect guaranteed the accuracy and reliability
of data produced by that laboratory.  Because of this,  it would appear
advisable to use some other term, such as "accreditation," "approval,"
"licensure," or "qualification."  (In California, for example, water an-
alysis laboratories are "approved" by the responsible State agency).  The
designation of a laboratory as "qualified," "accredited," or "approved"
would, in itself, express the fact that it had satisfied acceptability
criteria, but would be far less subject to the interpretation that EPA
assumed responsibility for the validity of the data generated by the la-
boratory.  It is considered, however, that in view of the regulatory imp-
lications of laboratory certification, which would provide EPA with a
legal basis for the rejection of data originating from unqualified sources,
that the use of a stronger term would be more appropriate.

This study was oriented primarily to policy related aspects of laboratory
certification, as seen from EPA's vantage point,  rather than to specific
technical considerations.  Thus, much of the ensuing discussion relates
to certification as a formal process rather than  to its technical details.
However, under a coordinated program EPA's Methods Development and Qual-
ity Assurance Research Laboratory, National Environmental  Research Center,
Cincinnati, Ohio, is sponsoring several studies,  in addition to this  one,
which are specifically technically oriented and which should prove direct-
ly contributary to both the attainment of the Agency's  QA objectives  and
to the implementation of a laboratory certification program.  The projects
which are specifically pertinent to the latter are:

           Development of a System for Conducting Inter-laboratory Tests
           for Water Quality and Effluent Measurements  (This project Is
           being conducted by FMC, Inc.)

           It is expected that this study will result in the design of
           detailed proficiency testing and similar procedures which,

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although addressed to water analysis laboratories, will
include guideline principles applicable to laboratories
engaged in developing environmental data relating to other
media (air, pesticides, etc.)

Protocol for Laboratory Inspection (This project is being
conducted by Tracor, Jitco, Inc.)

It is expected that this project will result in the develop-
ment of laboratory inspection and assessment procedures  and
criteria which will include considerations of general appli-
cability as well as those specifically related to analytic
operations oriented to specific media (air, water, pesti-
cides, etc.).
                        8

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                         IV STUDY FINDINGS

This Section provides a report on the investigative aspects of the study
and discusses certification program options developed during the formu-
lation of a preferred approach for EPA's consideration.  These options
are treated in terms of their pros and cons and the recommended plan is
assessed from a benefit/cost standpoint.  The following discussions are
organized on the basis of the study phases previously identified in the
Introduction.

Phase I:  Preliminary Survey

Certification Program Reviews:  Methodology

As part of this study phase a survey was made of existing certification
programs operated by Federal, State and private entities and was con-
ducted largely through telephone interviews and through the examination
and analysis of available descriptive materials supplied by the certify-
ing organization.  In performing the survey, emphasis was placed on those
programs which relate to analytical  and testing laboratories.   Other cer-
tification programs which are concerned mainly with product approval  or
with the accreditation of educational institutions were not reviewed be-
cause their purposes and goals are not germane to the objectives of this
project.

Over twenty organizations were identified as either directly conducting
certification programs or as influencing such operations.  All  of these
were examined and fourteen  were  selected for further  analysis.   This -se-
lection was based on  the following criteria:

     .   The organization currently conducts or is preparing to
        conduct a laboratory certification program.

     .   The program involves laboratories whose operations are
        either related to environmental  monitoring directly or
        are addressed to analagous analytical  or testing activities.

     .   Availability of sufficient information to permit a
        reasonably complete description of the certification
        process and requirements.
Certification programs and qualification criteria administered  or estab-
lished by the following organizations were examined,  but not selected
for analysis are as follows:

     .   Department of Defense, Defense Electronic Supply Center

     .   American Dental  Association

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      .  Law  Enforcement Assistance Administration

      .  The  National Committee for Careers in the Medical Laboratory

      .  American Chemical Society

      .  American National Standards Institute

      .  American Council of Independent Laboratories

      .  American Society for Testing and Materials

      .  National Bureau of Standards

The programs selected for further study are the following:

Federally Operated

      .  Food and Drug Administration (HEW, PHS), Bureau of Foods
           Approves State milk testing laboratories

      .  U.S.  Department of Agriculture, Animal  and Plant Health
        Inspection Service
           Certifies private meat inspection laboratories

     .  Center for Disease Control  (HEW, PHS)  Laboratory Licensure
        Section
           Licenses clinical  laboratories

     .  Occupational Safety and  Health Administration (Department of
        Labor,  Division of Safety Standards
           This Agency  contemplates  accreditation  of laboratories
           engaged  in the evaluation of safety of  products,  materials,
           installations,  etc.

     .  Social  Security Administration (HEW), Bureau of Health
        Insurance
           Qualifies independent  clinical  laboratories  for eligi-
           bility for reimbursement for services performed under
           the  medicare program.

      .  Office of Water and Hazardous  Materials  (EPA), Water Supply
        Division
           Certifies State laboratories analyzing  potable water on
           interstate carriers.

State Operated

     .  New York State  Department of Public  Health,  Division of
        Laboratories and Research
           Approves laboratories  for testing public  water supply
           samples.
                                  10

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     .   Oklahoma Department of Health,  Syphilis  Serology Proficiency
        Testing Program
           Certifies  clinical  laboratories  for serological  testing

     .   Oklahoma Water Resources  Board*
           Licenses water analysis  laboratories.

     .   Connecticut State Department of Public Health
           Approves private and municipal water  laboratories. ,

     .   California State  Department of  Public Health
           Approves laboratories  engaged in water quality testing.

     .   California State  Department of Public Health*
           Licenses clinical laboratories
Privately Operated

     .   American Industrial  Hygiene Association
           Accredits laboratories performing analyses  of air
           samples (from the working area)  and biological  speci-
           mens whose examination is dictated by work  related
           considerations.

     .   College of American Pathologists, American Society of Clinical
        Pathologists
           CAP accredits clinical laboratories.  ASCAP certifies
           laboratory personnel.

It should be noted that certain institutions, such as  the American Coun-
cil of Independent Laboratories and the American Society for Testing and
Materials have developed standards and criteria for laboratory perform-
ance which have contributed to the evolution of laboratory approval  pro-
cedures.  These organizations, nowever, do  not operate formal certifica-
tion programs and, for this reason, are not included in the above list.
   The synopsis of this program was developed during Phase II of the
   study.
                                 11

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The analyses of the fourteen selected programs are presented in Appendix I
as synopses which are based on a more or less uniform format structure.
This structure which was designed to emphasize the major program features
and elements specifically relating to EPA's own certification interests,
employs the following topical headings:

I    Background

     A.  Nature of Program

         The key functions of the program are briefly described together
         with other available general information.

     B.  Authority

         In the case of Federal and State programs, the authorizing or
         enabling legislation is identified.

     C.  Objective

         The essential purpose of the program is defined.

II   The Certification Process

     A.  Scope

         The principle elements of the certification process are iden-
         tified, as well  as the size of the program in terms of the
         number of laboratories approved or qualified under it.

     B.  Laboratory Elements Evaluated

         All factors relating to laboratory capability and operation
         which are examined and evaluated during the certification pro-
         cess are identified.   These factors or elements typically in-
         clude the basic  facility,  equipment, procedures, personnel
         and record keeping practices.

     C.  Procedure

         The procedure through which a  laboratory becomes certified  is
         summarized.   Procedures employed for recertification or for
         the maintenance  of certification are also identified.

Ill   Identified Problem Areas

     Any problems described under this  heading are those which were  .
     identified by certifying  organization personnel  (as opposed to
     personnel  of certified laboratories).
                                   12

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 IV   Program Administration and  Evaluation

      Information  provided  here deals primarily with the basic organiza-
      tion  of the  certifying entity and also identifies any methods used
      by  this entity  for assessing the effectiveness of its operation.

 V     Cost  and  Level  of Effort Estimates

      Where estimates of program  operating dollar costs, or equivalent
      data,  were available, such  information is included.

 VI   Comments

      Any general  useful information relating to the program which is not
      appropriate  to  the other headings is noted here.  This includes,
      for example, information regarding any interrelationships which
      may exist between the certifying organization described and other
      certifying entities.

 As had been initially supposed and as confirmed by the Phase I study,
 practically all laboratory certification programs are based on the same
 key elements which include the facility itself, the personnel and opera-
 ting  procedures.  The actual certification process is, as stated earlier,
 usually  implemented  through facility and personnel evaluation based on
 site  visits and on the analysis of information supplied by the applicant
 and through performance for proficiency testing.   Programs differ pri-
 marily with respect  to the degree of importance or emphasis placed on
 the above elements,  rather than in terms of essential  principle or ap-
 proach.  Table I on  page 14 presents a summary of the program synopses
 in a manner which permits ready comparison of the key elements of a given
 program with the corresponding elements of another.  The differences
 among these programs with respect to stress placed on different labora-
 tory elements can easily be noted.

 In performing this survey, it was usually possible to obtain consider-
 able  information about the certification programs and their important
 features through telephone interviews.   A consistent problem, however,
 was the difficulty of eliciting data  regarding program costs, either
 as a whole or on a per laboratory basis.   This difficulty did not appear
 to reflect any unwillingness or reticence on the  part of the interview-
 ees, but rather a surprising dearth of available  information.   The prob-
 lem was more severe  in the case of Federal  and State agencies than in
 that of private organizations.

 Within the context of the total  project,  the certification program stud-
 ies conducted under Phase I served two key purposes:   One of these was
 to provide information useful  in selecting case example programs  to be
examined in greater detail  in  Phase II.   The other was to clarify the
definition of the major elements  common  to most laboratory qualification
 programs and to detect any specific features of these  which could be
                                  13

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NATURE OF PROGRAM

Type of Laboratory Certified
Conmerclal
     Environmental
     Clinical
     Other1
Governmental
     Environmental
     Clinical
     Other1
Authority
     Not specific
  CAL.
                                                                        TABLE  I
                                                  ANALYSES OF CURRENT LABORATORY CERTIFICATION  PROGRAMS
                                            STATE PROGRAMS
CONN.
 N.Y.
 OKLA.
                                                                                              FEDERAL PROGRAMS
                                                                                                         PRIVATE ORGS.
 HEW,    EPA,    HEW, BUR.    USDA.    HEW          LABOR,    CAP     AIHA
 CDC     WSD     OF FOODS     APHIS    SOC. SEC.    OSHA
                                                                                                          NA
                                                                                                        NA
     Explicit Legislation
The Certification Process
Scope
     Number of laboratories
     Certified
     State examiners certi-
     fied by Federal Agency
Laboratory Elements Evaluated
Facility
     Stressed as Qualifica-
     tion requirement
     Noted as Qualification
     Requirement
     Not an explicit qualifi-
     cation requirement
  X X


450 2000

NA  NA
  60

  NA
100

 NA
200  37

 NA  NA



  X  X
700     SO(approx)   SO(approx) 166
300

  X
         NA      NA


NONE3  12,000    264

         NA      NA

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NATURE OF PROGRAM


Personnel
     Stressed as Qualifi-
     cation requirement
     Noted as Qualifica-
     tion requirement
CAL.    CONN.
N.Y.
OKLA.
HEW.    EPA.    HEW.BUR.    USDA.     HEW.         LABOR.    CAP.    AIHA
COC     USD     OF FOODS    APHIS     SOC. SEC.    OSHA
Procedures
Initial Certification Procedure
Site visit 1s performed
Proficiency testing
Certification Maintenance
Procedure
Reinspection
Proficiency testing
X X
X
X X
X
X X
X X
X
X
X
X
X
X
X
X
X
X
X
                                                                                               X

                                                                                               X
                                                                                               X
                                                                                               X
                                                                                                                 X
                                                                                                                 X
 1.   Programs  1n  this  category are principally concerned with food and product testing and also  Industrial health  laboratories.
 2.   NA means  not applicable.
 3.   The program  has not  yet been Implemented.
 4.   99 additional  applications  have  been received.  Final determinations concerning their accreditation will be
     made after the required site vists are  performed.
 5.   The American Society of Clinical  Pathologists  is responsible for personnel certification.
 6.   These laboratories are involved  in industrial  health  related areas  such as toxicology and the evaluation
     of the local working environmental air  samples.

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useful in developing program options under Phase IV.

Certification Program Reviews: General Findings

The studies conducted under Phase I confirmed an original  impression to
the effect that there are, as yet, very few certification programs di-
rected specifically to the licensing or approval of environmental  moni-
toring laboratories.  For this reason, the scope of the Phase I survey
was deliberately made sufficiently broad to include programs directed
to clinical and testing laboratories, since several such progams exist
which are well established and documented.  In principle,  the basic pro-
cedural features of these programs are inherently applicable to environ-
mental laboratories.  The major differences involve underlying policy,
institutional interrelationships and technical details, all  of which can
be readily separated from generic certification procedures and require-
ments.

The following discussion summarizes the general findings derived from
the analysis of the programs reviewed and is organized so  that topical
presentations are keyed to the format described earlier.

I    Background

     A.  Nature of Program

         Of the fourteen programs presented in Appendix I, five relate
         to the accreditation of clinical laboratories.  (The Oklahoma
         program approves both municipal  and private laboratories,
         while the other four deal with private laboratories exclusive-
         ly.)  Five of the programs listed (of which four are State op-
         erated and one is administered by EPA's Water Supply Division)
         are mainly concerned with the monitoring of public  water  sup-
         plies, although in some instances they also oversee laborator-
         ies engaged in effluent discharge analysis and  ambient water
         quality determinations.   Of the  four  remaining  programs,  three
         of which are operated by Federal agencies, two  deal  with  food
         testing by State and private laboratories and one with private
         laboratories involved in product testing and  one  with  private
         industrial  health laboratories.

     B.   Authority
         Federal  laboratory monitoring agencies vary with  respect  to
         the specificity of the legislative fiats under  which they op-
         erate.   For example,  the CDC program is authorized  by the Clin-
         ical  Laboratories Improvement Act of 1967 which requires  the
         licensing  of laboratories accepting specimens introduced  into
         interstate commerce.   Also,  HEW's Bureau of Foods'  certifica-
         tion program applying to milk testing laboratories  derives  its
         authority  from the Grade A Pasteurized Milk Ordinance which
         stipulates  that these laboratories be "official"  or  "officially
                                  16

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         designated," a status which must be achieved through inspection,
         evaluation and proficiency testing.  On the other hand, USDA's
         program for approving meat testing laboratories is not specifi-
         cally mandated under the 1906 Meat Inspection Act which the
         Agency generally cites as its authority.  Actually, this Act
         states that meat which is to be transported across State lines
         must first be Federally inspected and that the cost of such in-
         spection shall be borne by the Government.  Under this program,
         the private laboratories which inspect the meat act as agents
         of the USDA and their certification by this Agency is an ad-
         ministrative decision rather than a legislatively authorized
         and mandated requirement.

         Many State programs are either authorized under prevailing State
         health codes or are provided for under general  administrative
         statutes.  On occasion, however, statutory language may be some-
         what liberally interpreted in program execution.   For example,
         the California State Department of Public Health "approves"
         water laboratories under Article 2 of Group 6,  Title 17, enti-
         tled "Need and Authority for Approval", specifically references
         "water supply".  However, it appears  that the "approval" mech-
         anism is applied to laboratory operations addressed to the anal-
         ysis of effluent and ambient water as well as to drinking water.

     C.  Objective

         Various certification programs define their objectives in dif-
         ferent ways, some of which are quite  broad and  loosely worded,
         such as "the protection of the public health, safety and wel-
         fare".   In all  cases, however, they are obviously addressed to
         the enhancement of the reliability and quality  of the data re-
         lating to their area of administrative activity.

II   The Certification Process

     The certification program synopses presented in Appendix I  are not
     designed to describe every detail  of the  criteria and processes
     they summarize.   These descriptions  were  developed  with  the primary
     goal  of identifying those elements which  are the distinctive policy
     and procedural  aspects of the programs  examined and which  EPA would
     consider,  at least  generically,  should  it elect to  implement formal
     certification of environmental monitoring laboratories.  According-
     ly, the program descriptions  emphasize  key procedural mechanisms
     and factors rather  than  specific  technical  considerations which
     tend  to reflect only the specific  area  of activity  of a  given  lab-
     oratory category.

     A.   Scope

        The range of  program size, in  terms of  the  number of laboratories
                                  17

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    certified, is considerable and falls within extreme limits of
    25 at the low end to 12,000 at the high end.  The scope of these
    operations was also examined in terms of utilization of person-
    nel in other organizations which were not a direct part of the
    certifying agency.  It was found that three Federally operated
    certification programs utilize State personnel for the perform-
    ance of laboratory inspection and evaluation.

B.  Laboratory Elements Evaluated

    Facility

    Virtually all certification programs include facility evaluation
    which is generally performed through both on-site visits and
    the review of information supplied by the applicant (such in-
    formation is usually submitted prior to the site visit).

    Laboratory Procedures

    In nearly all instances laboratory procedures are required to
    conform with standard methods as set forth in designated lab-
    oratory manuals or reference texts.  Deviations are sometimes
    permitted, but usually only when the laboratory can demonstrate
    satisfactory methods equivalency.   During the interviews, most
    of the certifying entities stated  that internal laboratory
    quality control is a prerequisite  for approval.  However, it
    was found that the term "quality control" is interpreted dif-
    ferently by different organizations and, in many cases,  means
    only that laboratory equipment must be periodically calibrated.

    Personnel
    All programs, without exception, consider personnel  qualifica-
    tions.  Three of them lay particular stress on specific details
    of training and experience.

C.  Procedure

    Most of the certification procedures examined in  Phase I include
    three key elements, as follows:

          Examination and assessment of information supplied by
          the applicant laboratory.   This information is usually
          provided on forms provided by the certifying organiza-
          tion.   Aside from the  differences in these  forms which
          reflect the different  technical  natures of  the labora-
          tory operations, there are also differences with respect
          to the level  of detail  required.
                              18

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               Direct laboratory inspection and evaluation.  This
               is accomplished through on-site visits, as mentioned
               earlier.  These visits are usually pre-arranged.  Some
               programs require that the inspection personnel must
               themselves be certified.

               Performance testing.  Split sample or similar check
               procedures are employed by practically all certifying
               entities.  In many cases performance testing is an
               integral part of the initial certification procedure.
               In some, performance testing is employed only in con-
               nection with certification maintenance or with recerti-
               fication.

Ill  Identified Problem Areas

     The problem areas identified in the various certification programs
     studied necessarily represent those difficulties perceived by the
     program representatives with whom interviews were conducted.  It
     therefore does not follow that these problems, as articulated, in-
     clude all of those which may actually exist.  In most cases, the
     problems mentioned reflected, in one way or another, the difficulty
     of operating with inadequate funding resources.  Typical manifesta-
     tions  of severe budget limitation include inadequate proficiency
     testing programs, insufficient numbers of trained laboratory in-
     spectors and a general  and pervasive lack of capability for per-
     forming certification program activities at a level  of effective-
     ness considered desirable by the responsible organizations.

IV   Program Administration  and Evaluation

     It is not possible to generalize with respect to program administra-
     tive practices and organizational  structure.  For example, some of
     the certifying entities conduct centralized operations while others,
     such as the Social  Security Administration, make greater use of re-
     gional and local  personnel.

     Most of the certifying  organizations surveyed do not have formally
     established procedures  for evaluating the effectiveness of their
     programs.  This is  considered to be, possibly,  the most serious
     shortcoming common  to these operations as a whole.   In general,
     they depend on such haphazard and  unsystematic  feedback as may be
     forthcoming from  field  inspectors  and from personnel  in the  certi-
     fied laboratories.

V    Cost and Level  of Effort Estimates

     In most instances,  as has  already  been  indicated,  specific operating
     cost data for the programs examined  was  not  available.   Although,  in
     some instances, the fees charged by  the  certifying organizations
     were provided,  there was little  reason  for assuming  that these bore


                                   19

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     a meaningful  relationship to actual costs.  Estimates of the time
     required  for  the  performance of  laboratory  inspections ranged from
     about one to  two  days, excluding travel and report preparation.  In
     general,  it was believed that one  inspector could "cover" up to,
     but  not more  than 100 facilities per year.  No useful information
     was  obtained  with respect to precise proficiency testing costs, al-
     though the supervisor of the Oklahoma Department of Health's Syphil-
     lis  Serology  Proficiency Testing Program estimated that one to two
     manhours  are  required to evaluate  laboratory performance in a given
     test area.  Other specific costs incident to proficiency testing
     such as reference sample preparation and distribution, data handling
     and  analysis  and  the like do not appear to  have been identified and
     categorized in the programs studied.  Further, it did not appear
     that most program representatives  had carefully considered the in-
     direct or overhead costs of certification program operation.


Opinion Survey:  Methodology

Numerous interviews were conducted  with EPA personnel,  State  environment-
al agency officials and representatives of private  environmental  monitor-
ing laboratories,  principally,  but not exclusively,  by telephone.   Most
of these interviews were performed  during the Phase I  portion of the
study.    It was assumed that, should EPA elect to adopt a  certification
program, much of the responsibility for its actual  implementation would
devolve on the Regional Office staffs and, for this reason,  QA personnel
from all ten  EPA Regions were included among those interviewed.   The over-
all objective was to sample the views and opinions  of those who would be
involved with conducting the program as well as those to whom it would
be addressed.

Opinion  Survey:  General Findings

The  following  presentation, which summarizes the views encountered in
this survey,  is organized according to the entities with which the inter-
viewees  were  associated.  Few, if any, of those interviewed discussed
the  topic  of  enviornmental monitoring  laboratory certification on a comp-
rehensive  basis.  The  usual tendency was to emphasize those particular
aspects  of the subject which related directly to the individual s spe-
cific activities  or interest.  The summary below does not reflect all
comments elicited, but does take into  account those considered to pre-
sent some  definitive  position.  It is  emphasized that the opinions here
represent  individual  viewpoints and should not be construed to reflect
organizational positions.  Further, any inconsistencies among the view-
points below, which appear in association with a given entity, resulted
from discussions with more than one individual affiliated with that en-
tity.
                                   20

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Entity

  EPA Headquarters

     Office of General  Counsel
Opinions Expressed
EPA should certify all laboratories di-
rectly as opposed to certifying intra-
state laboratories via State agencies
because

  .   This would avoid a drain on State
     resources

  .   States cannot muster sufficient
     personnel to operate programs

  .   More uniform application of certi-
     fication standards will  be achieved
     Office of Legislation         Enabling legislation should  be in
                                   effect prior to program initiation
                                   to  establish authority.

                                   The term "certification"  is  less  de-
                                   sirable, because of  its  implications,
                                   than alternative terms.

     Water Planning  and  Standards   The Office of Water  Planning and
     (Monitoring  and Data           Standards would support certification.
     Support Division)              ..   u_       .  ..   .    .,
                                   No  HQ  organizational  problems  are
                                   foreseen.  State should certify pri-
                                   vate laboratories.

                                   EPA should collaborate with the States
                                   in  the development of QA  programs
                                   prior  to initiating  certification
  EPA Regional Offices

    Region I
  EPA  should certify  State  laboratories
  only, with the  States certifying  intra-
  state laboratories.

  Although private  laboratories engaged
  in effluent monitoring are required
  to observe QA practices,  they are
  under pressure  from the discharger
  employing their services.  Certifica-
  tion, accompanied by suitable regula-
  tory procedures, would promote data
  accuracy and objectivity.
                                  21

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Entity

     Region II
     Region  III
     Region  IV
Opinions Expressed

States should certify intrastate
laboratories.
EPA should develop uniform standards.
Reference samples should be produced
by NBS or commercial firms and dis-
tributed by them to State agencies.

A certification program should be ad-
ministered from EPA HQ and should be
uniformly applied throughout all re-
gions.
The program should begin with water
laboratories, possibly with those en-
gaged mainly in effluent analysis.

States should certify private labora-
tories using existing trade associa-
tions.
EPA's direct certification of intra-
state laboratories could be regarded
as infringement (on State prerogatives).
EPA should retain a liaison with cer-
tifying State agencies,  possibly a
monitoring relationship.

EPA should provide free training to
State agency personnel.

States should certify intrastate lab-
oratories.
EPA would gain no real  advantage in
certifying State laboratories because
these are being covered under the QA
program.
EPA should provide reference samples
and consistent criteria  for data re-
liability.
EPA should perform periodic perform-
ance testing (interlaboratory) of
State certified laboratories.
EPA should provide training for State
laboratory personnel, with the States
training  intrastate laboratory person-
nel.
                                22

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Entity


     Region V
     Region VI



     Region VII
    Region VIII
    Region IX
 Opinions Expressed


 EPA should initiate certification in
 relation to water laboratories

 Many States would require legislation
 to implement program.

 Private laboratories, in most instances,
 would welcome certification.

 EPA should provide respositories of
 test samples and reference standards.

 Certification should be optional with
 the States.  Most States lack adequate
 manpower to conduct the program.

 Funding is a  key problem;  most State
 laboratories  (in reference to Region
 VII)  are badly equipped  due to lack
 of resources.

 Grant support  to States  is essential.

 Region VII itself would  require ad-
 ditional  funding.

 There exists no  current  authority for
 unannounced laboratory inspection;
 this  would be  necessary  under a  certi-
 fication  program.

 EPA should certify to State  level
 only;  States should certify  intrastate
 laboratories.

 States  should  be  permitted to  provide
 inputs  to  certification  program  formu-
 lation  to  avoid  possible later resist-
 ance.

 Private laboratories performing efflu-
 ent analyses and stack emissions test-
 ing must attest to the accuracy of the
 data they  report;  hence, certification
 is superfluous.

 EPA should certify to the State level
 only, with the State agencies certify-
 ing intrastate laboratories.

 EPA should initiate certification with
water laboratories.
                                  23

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Entity

    Region X
  State  Laboratories
   (air  and water)
 Private Laboratories
 Opinions Expressed


 EPA should  initiate certification  with
 air laboratories because there are
 fewer of these (than of water labora-
 tories)  and thus the program  would be
 easier to implement at  the  beginning.

 Because  laboratories perform  a variety
 of  procedures,  certification  should
 be  based on specific test and analysis
 capabilities  (as opposed to a compre-
 hensive  certification of the  labora-
 tory  as  a whole).


 Certification by EPA would  impose  no
 real  burden since the officials inter-
 viewed considered that  capabilities
 and performance were of sufficiently
 high level  to ensure that their labor-
 atories  would experience no difficul-
 ties  in  complying with  any  reasonable
 standards and criteria  EPA might es-
 tablish.

 The concept of formal certification
 of  intrastate laboratories by EPA
 directly was,  in all  instances,  re-
 garded as totally unacceptable and
 representing  a  violation of State
 prerogatives.

 (The  State  agencies  interviewed were,
 on  the whole,  those  recognized as
 conducting  high  quality monitoring
 operations; therefore, their  view
 that  State  laboratory certification
 by  EPA would not  be  burdensome, at
 least  on technical grounds,  should
 not be construed as necessarily typi-
 cal of the position other States might
 take.)

 Representatives of the independent
 private laboratories interviewed wel-
comed the idea of certification be-
cause they considered that this would
remove the competition now experienced
from organizations regarded  as tech-
nically inferior.
                                24

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  Entity                             Opinions Expressed

                                    (This opinion was elicited from a rel-
                                    atively small sample of laboratories
                                    generally regarded as competent. There-
                                    fore, it is not presented as necessar-
                                    ily typical.)

 In general, many EPA Regional  Office personnel interviewed independently
 agreed that an environmental  monitoring laboratory certification program,
 if implemented, should:

      .  Provide for certification of State laboratories, with the
         States assuming  responsibility for the certification of
         intrastate laboratories.
      .   Be initiated in  connection with water  laboratories,  and then
         expand from there  to encompass  other programs.   (The basis
         for this  view is in part  the  large number  and diversity of
         water  laboratories now reporting data  under  the  NPDES  pro-
         gram.   Most Regional Office personnel  interviewed  consider
         that effluent compliance  monitoring requirements  impose
         some of the most significant  pressures  they  now  face with
         respect to  the administration of water  programs.)

      .   Provide training and assistance to State agencies  to facilitate
         program establishment  and  implementation.

      .   Provide for funding State  certification programs and Regional
         Office support.
Phase  II;  In-depth Program Studies

Methodology

It had been considered that through direct on-site interviews with certi-
fication program officials and with the personnel of laboratories certi-
fied under their programs it should be possible to elicit information,
viewpoints and suggestions which could be helpful to EPA in the develop-
ment of its own certification operation.  On the basis of the preliminary
certification program survey conducted under Phase I and supplementary
information, the eight programs identified below were selected for fur-
ther study.  In this selection process, both the appropriateness of spe-
cific programs and the representativeness of the administering entities
were considered.  Thus, the list includes two Federal, four State and
two private operations.

Federally Operated

     .   Food and Drug Administration,  Bureau of Foods
           Milk testing laboratories

                                   25

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        Public Health Service, Center for Disease Control
           Clinical laboratories
State Operated
      .  Connecticut Department of Health
           Water quality laboratories

      .  New York Department of Public Health
           Potable water quality laboratories

      .  Oklahoma Water Resources Board
           Water analysis laboratories
      .  California Department of Public Health
           Clinical laboratories

Privately Operated

      .  American Industrial  Hygiene Association
           Industrial  health laboratories

      .  College of American Pathologists
           Clinical laboratories

The interviews with program officials were, to the degree possible,
structured to incorporate at least the following three elements:

      .  Review of program synopsis for updating, general  accuracy
        of the presentation and modification or correction of de-
        tails, as appropriate.  (The synopses, which appear in
        Appendix I, reflect any changes made in consequence of
        these reviews.)

      .  Elicitation of program overview, as seen by the inter-
        viewee, and details  of actual program operation.

      .  Elicitation of information regarding perceived problem
        areas, program costs and program benefits.

      .  Elicitation of suggestions for EPA's consideration in
        formulating its own certification program.

The interviews with personnel  associated with the certified laboratories
were designed to elicit the following:

      .  Estimation or  opinion of program benefits to the  labora-
        tory.

      .  General experience with the program in terms of any
        difficulties associated with compliance as well as
        perceived problem areas.
                                  26

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     •   Program suggestions  for  EPA's  consideration.

(Where possible, the interviews were conducted with program and labora-
tory directors or other key personnel  and samples of printed program
materials (such as descriptive information and laboratory appraisal
forms)  were obtained.)

General Findings

Key informational findings and opinions elicited during the Phase II
portion of this study are presented below by program.  Factual informa-
tion and expressions of ooinion are listed under separate headings for
identification.  In general, a considerable amount of the program in-
formation provided was already known to the interviewers and is synop-
sized in Appendix I.  Therefore, informational elements appearing in
the following presentation are largely those which do not appear in the
synopses.  Reference to the appropriate summaries in Appendix I will be
helpful in reviewing the following presentations.

FEDERALLY OPERATED PROGRAMS

HEW, Food and Drug Administration, Bureau of Foods
  Program:Approval of Milk Testing Laboratories

Certifying Entity

Factual Information

     .   All 50 States participate in this program on an essentially vol-
        untary basis.  Progam standards, criteria and procedures are
        based on the "Grade 'A1  Pasteurized Milk Ordinance" and detailed
        in an issuance of PHS's Division of Environmental Engineering
        and Health Services entitled "Evaluation of Milk Laboratories".

     .   The Laboratory Development Section (LDS) has approved 65 State
        central laboratories.   These in turn, have approved approximate-
        ly 800 local municipal,  industrial and commercial laboratories.
        State laboratory evaluation personnel must be themselves certi-
        fied by LDS.  Milk testing laboratories are approved and their
        analysts certified for specific procedures.  Proficiency test-
        ing using split samples tends  to dominate the overall  qualifica-
        tion process.

     .   Of the 65 approved State central laboratories,  25 are re-evalua-
        ted each year on the basis of  site visits, during which on-going
        laboratory procedures  are observed and assessed.  It was estimated
        that the average level  of effort per laboratory inspection is
        3-man days.

     .   The mechanism for "feed-back"  of evaluatory information to the
        State central laboratories includes the following elements:
                                  27

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               The laboratories are informed of specific "deviations" .
               which were detected during the site visit and which
               should be corrected.

               After completion of proficiency re-testing (at least
               on an annual  basis) and analysis of the results,  the
               evaluations are then transmitted to all laboratories
               simultaneously.  Thus, each laboratory can rank its
               performance against that of other State central  labora-
               tories.                                              	
Opinions Expressed

     .   The principal program benefit is perceived as an improvement in
        the precision and accuracy of laboratory data.

     .   Favorable attitudes  to people and correct interpersonal  relation-
        ships (Federal/State personnel) are considered vital  to  effective
        program implementation.

     .   If resources were available,  the program would benefit from the
        the following:

               Increased frequence of proficiency testing to  twice.
               annually

               The preparation of audio/visual  tape presentations  of
               all  laboratory techniques as instructional  aids for
               State and local  laboratory personnel.

               A more extensive  seminar  program.

               The establishment of a system of regional  consultants
               who would assist State laboratories  in technical  matters.

               More frequent revision of guidance materials.

               Evaluation of State central  laboratories  every two,
               rather than every three years.

     .   A  central  to regional  to State form of  program organization
        is preferable to the central  to State type  of operation  which
        now exists.

     .   A  "strong"  central support staff is  essential.

     .   An evaluatory Federal  inspection and  evaluation agency with
        multi-disciplinary competence (for  the assessment of many
        types of  laboratory  operations)  would be desirable in order
        to minimize  the  number  of  site  visits to laboratories engaged
        in several categories of programs.
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Certified Laboratory (City of Cincinnati Health Department Laboratory)

Factual Information

     .  No significant factual information beyond that already avail-
        able was elicited.

Opinions Expressed

     .   Perceived program benefits:

               The facility and its  equipment were upgraded in conse-
               quence of deficiencies noted during evaluation.

               Laboratory procedures became more standardized.

               Information supplied  with respect to results of pro-
               ficiency testing was  contributory to performance
               improvement.

               An overall improvement in the quality of data generated
               by the laboratory.

     .   Criticisms of Program/Problem Areas:

               Biennial laboratory evaluations may be redundant.

               Because the milk sample collection system is unre-
               liable, sample representativeness and holding times
               are uncertain, with possible adverse effects on data
               accuracy.

               Split samples used  in proficiency testing are identi-
               fied as such; "blind" samples would provide a better
               basis for performance assessment.

HEW. Public Health Service. Center for Disease Control  (CDC)
  Program:Licensing of Clinical  Laboratories (engaged in interstate
            commerce)

Certifying Entity

Factual Information

     .   All clinical laboratories  (engaged in interstate commerce) are
        covered by the program.  Currently, there are 700 licensed
        laboratories.  In addition,  about 1,500 "voluntary" laborator-
        ies (non-licensed) participate in proficiency testing activities.
        Small laboratories which process less than 100 samples per year
        are exempted from the requirements of the Clinical Laboratories
        Improvement Act under which  the program is mandated.
                                   29

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        All Medicare laboratories will  soon be included in the program
        and, since these number about 5,000 to 6,000, there will  be an
        appreciable strain on the inspection capabilities of the  pro-
        gram.  The present laboratory inspection staff of nine performs
        about 1,000 inspections per year.  CDC's Laboratory Licensure
        Section staff totals 67 technical, administrative and cleri-
        cal personnel and receives support from the Agency's Labora-
        tory Division whose staff is about 800.

        The program is funded at the rate of approximately $9,000,000
        annually, of which a considerable amount is expended on pro-
        gram improvement.  It was found difficult to determine the
        annual amount spent on laboratory licensing activities as
        such, but this is believed to be in the neighborhood of
        $2,000,000.

        Because the primary objective of the program is laboratory
        performance improvement considerable stress is laid on pro-
        ficiency testing (which is conducted quarterly).  Results
        are  fed  back to  the participating laboratories on a system-
        atic  basis.

        The effectiveness of the program is reflected by the fact
        that laboratories new to it show an average deficiency rate
        of 21.4 as opposed to a rate of 9.9 for laboratories partici-
        pating in the program for longer periods.

        Operation of the program is conducted either directly by
        CDC or through the College of American Pathologists (CAP)
        and through State agencies (in theory).  (At present, how-
        ever, the only State approved by CDC is New York.)  About
        10% to 20% of the laboratories  qualified under the CAP and
        New York programs are audited by CDC.

        The present CDC program is being modified to (a)  augment
        the objectivity of the internal  QC program and on-site
        profile check lists and (b) strengthen the proficiency
        testing grading system and delisting criteria.  For ex-
        ample, at present a laboratory  must score four unsatis-
        factory quarters in a row before it is delisted.   A moving
        average system which would be a  more responsive indicator
        of poor quality work is now being considered.
Opinions Expressed
        CDC officials consider the following  essential  to  an  effective
        laboratory accreditation program:

               Standards must be formulated on  the  basis of an
               objective concensus.
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                Explicit standards and criteria must be stated
                in the regulations.

                The licensing authority must maintain control  of
                the program.

                Facility evaluation must be  based on a check list
                to eliminate  subjectivity on the part of  the in-
                spector.

                A  proficiency testing  program must be maintained
                on a  regular  basis.

                The licensing authority,  not the State, should
                delist.

                Data  processing should  be  automated.

                If State  programs exist, the State should evaluate
                and the  Federal agency  should accredit.

                Facility  inspection check  lists  should be designed
                to objectivize the process to the degree possible.
                For example, questions  should be answerable in terms
                of  "yes", "no", "NA", or numerically.

     .  It is suspected that some laboratories may send their pro-
        ficiency testing samples to outside analysts and then repre-
        sent the results as their own.

     .  The CDC Administrators believe that their experience in
        operating the laboratory accreditation program could be
        effectively used by other agencies.

Certified Laboratory (Northern Virginia Pathology Laboratories)

Factual  Information

     .   Northern Virginia Pathology Laboratories (NVPL) are
        accredited under the  programs  of both  the Center  for
        Disease Control  (CDC) and the  American  College of
        Pathologists  (CAP).   The  facility is large,  with  a
        staff of 160 to  180 and  is  qualified for all  major
        categories of both  programs in which they have par-
        ticipated  since  their inception.

     .   The laboratories are  inspected by  CAP every  two years
        and perform self-inspection on alternate years.   These
        self-inspections  are  conducted  on  an inter-departmental
        basis,  i.e.,  technicians  associated  with some given de-
        partment inspect a different department.
                                 31

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     .   NVPL employs certain internal  quality control  procedures
        which are not required under either the CAP or CDC programs.
        For example, in addition to running standards  through analy-
        sis equipment on the basis of every tenth reading, unknowns
        are submitted to the operating technicians. Also, statisti-
        cal records of mean values of all  analyses are maintained.
        A drift in these means, up or down, from historic values is
        interpreted as a warning signal  indicating the possibility
        of a laboratory operational problem.

Opinions and Observations Expressed

Because the laboratories are qualified under both CAP  and CDC, the  offi-
cials interviewed were in an excellent position to provide a comparison
of the two accreditation programs as seen  by a working laboratory.  Their
observations synopsized below therefore include references to both  of
these programs and also reflect comparative assessments.

     .   The CDC program appears more mandatory in nature.  For
        example, although the CAP and CDC deli sting procedures are
        quite similar, CDC letters citing deficiencies are "tougher"  and
        more authoritative in tone.  Therefore, the laboratory tends  to
        react more strongly to unsatisfactory results  reported back
        under the CDC program.

     .   Although both CDC and CAP take pride in their  systems
        for feedback to the laboratories (of evaluations) and
        both organizations devote considerable effort  to  the
        completeness of statistical reporting, NVPL believes
        that the data sent back is needlessly complicated.

     .   On-site inspections conducted  by CDC are considered
        more uniform than those performed  by CAP,  although
        the CAP checklist is more objective.  This is  attribu-
        ted to the fact that CDC employs full-time inspectors,
        while CAP uses volunteer pathologists.

     .   It was felt that both organizations ask too many  trivial
        questions and dwell  too heavily  on OSHA (Occupational
        Safety and Health Administration)  requirements.   NVPL
        believes that OSHA should concern  itself with  safety
        considerations and that CDC and  CAP should be  less oc-
        cupied with the number of fire extinguishers available
        and more with such matters as  analytical  equipment and
        procedures that bear directly  on laboratory performance.

     .   NVPL believes that its self-inspection may be  more rig-
        orous than the CAP inspection.

     .   NVPL believes that CDC should  be more  specific in the


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        formulation of its requests.  For example, ambiguities
        sometimes result because findings are reported in dif-
        ferent units from those desired by CDC and in these cases
        the results are considered incorrect, even though the
        analyses may have been accurate.

     .  Sometimes, standards suggested by CDC for use in main-
        taining equipment calibration could not be obtained
        (by them).  NVPL believes that CDC should provide the
        participating laboratories with specific information
        as to where such standards are commercially available.

     .  The cost of accreditation (to the laboratory) was con-
        sidered reasonable.

     .  NVPL considers that yearly on-site visits performed
        by full-time inspectors coupled with quarterly pro-
        ficiency testing constitute the basis of an effective
        laboratory approval program

STATE OPERATED PROGRAMS

Connecticut State Department of Health, Laboratory Standards Section
  Program:  Approves Water Laboratories

Certifying Entity

Factual  Information

     .   The State Department of Environmental  Protection,  which is
        responsible for the maintenance of Federal/State standards,
        does not operate its own water analysis  laboratories,  but
        depends on local  laboratories which require annual  approval.
        This requirement provides the Laboratory Standards  Section
        with considerable control  in  that a laboratory found unac-
        ceptably delinquent may be declared a  health  hazard by the
        State Department of Health and immediately closed  down.

     .   Both municipal  and  private laboratories  are approved under
        the program.   These include facilities performing analyses
        of potable water as well  as sewage plant and  industrial
        effluents.

     .   The initial  approval  process  includes  site inspection  and
        evaluation,  but the program as a  whole,  particularly annual
        re-approval,  rests  largely on proficiency testing which  is
        highly emphasized.   Test  samples  are sent to  the laboratories
        by the Laboratory Standards Section and results are-provided  to
       the laboratories within approximately three weeks.   The results
       are expressed in comparative terms, showing the laboratory's
                                33

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        score for a particular test vs. the mean result of all
        peer laboratories.  It was estimated that the average
        annual proficiency testing cost per laboratory, for all
        analyses, lies between $300 and $400.

Opinions Expressed

      .  The agency regards the key objective of its program to
        be laboratory improvement, rather than laboratory approval
        as such.  That is, Laboratory Standards Section personnel
        are more concerned with upgrading laboratory performance
        than with the maintenance of minimal standards.  They appear
        to feel that a Federally operated program is more apt to
        adopt minimal standards as a working goal and this approach
        they find totally unacceptable.

      .  The Laboratory Standards Section regards its program as
        highly successful as judged by the responses of the labora-
        tories they evaluate.  They find the laboratories eager to
        receive test results quickly and very willing to receive
        prompt help from the Section when problems develop.

      .  The most serious perceived problem relates to test sample
        preparation.  Samples have been obtained from EPA NERC/
        Cincinnati at no cost so far and will still be available
        from QALE Branch, though possibly not in the required
        amounts.

Certified Entity (Bridgeport Hydraulic Company Laboratory)

Factual Information

      .  No significant previously unknown factual information
        about the programs or its operation was  provided.

Opinions Expressed

      .  The Laboratory Standards Section's  program is  well
        regarded.   It has been found helpful  in  correcting
        technical  problems and has  provided the  basis  for
        upgrading laboratory equipment.

      .  The program is judged to be too lenient  in eliminating
        laboratory operations of questionable quality  and  should
        be firmed up in this respect.

     .  The response of the  State agency to laboratory data submis-
        sion,  is considered quite rapid and it was doubted that a
        Federal  operation could respond as quickly.
                                 34

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      .  It was felt that where State agency programs are now
        operating effectively, they should be permitted to
        continue without Federal interference.  However, where
        States have no effective certification or licensing
        apparatus, the introduction of a Federal program may
        be the only realistic solution.

      .  Two desirable Federal roles are seen as:

               Establishment of uniform measurement standards
               which would compel laboratories to use modern
               equipment.

               Provide guidance to laboratories in the cost/
               benefit evaluation of modern competitive analy-
               tic instrumentation.

New York State Department of Health, Division of Laboratories and Research
  Program:  Approves Laboratories Analyzing Potable Water

Certifying Entity

Factual Information

      .  Laboratories are rated as either "satisfactory" or
        "approved".  A "satisfactory" facility is one which
        has passed inspection with respect to the facility,
        equipment and demonstrated skills of the technicians,
        but which has no professional staff.  An "approved"
        laboratory is one which is both "satisfactory" and also
        has a professional  staff.  "Satisfactory" laboratories
        are generally those associated with municipal  water-
        works.  "Approved"  laboratories are usually independ-
        ents.  Directors of "approved" laboratories must hold
        bachelors' degrees, as a minimum.

      .  The agency is quite small with very limited resources.
        It does not have a  reference sample system and, there-
        fore, does not maintain a proficiency testing  program.

Opinions Expressed

      .  The program is frankly regarded as  inadequate  because
        of the lack of fiscal  and personnel  resources.

      .  The lack of proficiency testing program,  which should
        cover all  relevant  water pollutants, is  seen as the
        dominating problem.
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Certified Laboratory (Bender Hygienic Laboratory,  Albany,  New York)

Factual  Information

     .   No significant additional  factual  information about the
        program was acquired from the laboratory personnel.

Expressions of Opinion and Observations

     .   Program benefits were said to include:

               Improved working relationships with State personnel.

               The weeding out of poorly qualified laboratory per-
               sonnel  (as a result of the laboratory inspection
               process).

               Increased uniformity of data quality among  labora-
               tories.

               Improvement of laboratory personnel morale.

     .   Program shortcomings identified were:

               Inadequate transfer of information  from the
               State program agency to laboratories qualified
               under it.  In general, it was felt  that the pro-
               gram does not keep laboratories  up-to-date
               regarding preferred technical procedures and
               administrative policies, except  in  the cases
               of major issues.   For example, laboratory
               personnel were unaware of the distinction be-
               tween a "satisfactory" and an "approved" rating.

     .   Various general  suggestions were made regarding suitable
        elements for incorporation within an EPA certification
        program, as follows:

               EPA should certify State laboratories; the  State
               should  certify intrastate laboratories.

               Federal funding should be made available to  State
               programs.

               EPA should conduct workshops and seminars for
               State personnel.

               EPA's program should include a provision for
               checking  the States'  proficiency testing operations.
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               EPA should encourage the State agencies to hold
               seminars for intrastate laboratory personnel.

     .   Specific suggestions with regard to proficiency testing were:

               Initial  test samples used in the EPA/State programs
               should be identified to "avoid hostility".  These
               first interlaboratory tests would be thus aimed at
               determining achievable levels, rather than routine
               performance.

               In later program steps, obviously spiked samples
               should then be introduced and, finally, routine
               "unkowns".

               State laboratories should receive ratings for  all
               performance tests.

               State laboratories should have the authority to
               require EPA Regional Office (or other EPA pro-
               ficiency testing) laboratories to analyze State
               prepared test samples.  (It was considered that a
               system providing for mutual EPA/State competence
               checking would enhance interagency relationships.)

Oklahoma Water Resources Board
  Program:  Certifies Water and Wastewater Laboratories

Certifying Entity

Factual  Information

     .   The Oklahoma Water Resources Board (OWRB) instituted  its
        laboratory certification program about two years ago  after
        it had determined that a significant number of reported
        analytical results relating to industrial effluent dis-
        charges was found inaccurate.

     .   Proficiency testing is accomplished through the cooperation of
        the United States  Geological  Survey's  (USGS) Denver Labora-
        tory which supplies reference samples.  The USGS charge for
        this service is about $35.00 per sample, to which OWRB adds
        $5.00 for handling.

     .   Of about 37 laboratories now participating in the program
        10 or 12 are independent commercial   organizations.  The
        balance are either municipal or industrial  laboratories.
        In addition to sample charges to the laboratories, there
        is an initial application fee of $25.00 and an annual
        certification renewal cost which is also $25.00.
                                   37

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     .   Proficiency testing is performed once annual  in order
        to minimize program costs.   Further,  neither  initial
        nor annual  site inspections are routinely conducted.
        However, the OWRB maintains 62 industrial discharge
        check points and compares its own analyses (of these
        effluents)  with those received from laboratories opera-
        ting under  the program.  In the event that the laboratory
        data does not appear to be correct or is  inconsistent
        with that of the OWRB, State agency personnel  then make
        on-site visit to the laboratory in question.

     .   Of the funds now annually received by Oklahoma from EPA,
        about $112,000 is allocated for the OWRB  operation.  The
        estimated cost of the certification program itself is
        approximately $5,000 per year.

Expressions of Opinion

     .   OWRB considers that routine annual on-site visits coupled
        with quarterly proficiency testing would  be ideal.

     .   Because most water analysis laboratories  in the State are
        small, it is believed that the cost (to them)  of remaining
        in the program is a significant economic  consideration.

     .   OWRB favors an EPA administered program,  with  intrastate
        laboratories certified by the State.

     .   Every certified laboratory should meet national standards
        and should  receive reference samples  from the  same source.

Certified Laboratory (Oklahoma Gas and Electric Company's Water Laboratory)

Factual Information

     .   This laboratory is certified as AAA by the OWRB, which
        means that  it is considered competent in  all  three cate-
        gories of qualification (see program synopsis  in Appendix I).

     .   Reference samples are received annually from  the USGS
        laboratories in Denver and the analytical results are
        returned to them directly.   USGS evaluates the test
        data and transmits the rating information to OWRB.

     .   In the case of the Oklahoma Gas and Electric Water Labora-
        tory (OGSE), OWRB did make an initial  site survey in  which
        it examined and evaluated:

               Personnel
                                   38

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               Laboratory equipment list

               Internal quality control program

               Analytical procedures

Opinions Expressed

     .   Pollutant concentrations in proficiency test samples
        are often more dilute than those typically encountered
        and it is considered that more realistic samples,  pro-
        vided on a quarterly basis, would improve the program.

     .   OG&E strongly supports the program and believes that
        OWRB requirements have enabled the laboratory to justify
        more and better equipment.

California Department of Health, Laboratory Field Services
  Program:  Licenses clinical laboratories and personnel

Certifying Entity

Factual Information

     .   Laboratory licensing was initiated in 1937 and personnel
        licensing in 1938.   The requirement that physicians'
        office laboratories, although exempt from licensing,
        must participate in an approved proficiency testing  pro-
        gram, was initiated in 1972.

     .   Personnel licensing categories are defined and, in most
        cases, the license  issued may be either general or
        limited (that is, limited to a specialty such as clinical
        microbiology or clinical  toxicology).   These categories
        and their requirements are:

        .  Trainee:  requires a bachelor's degree

        .  Technologist:  requires a bachelor's degree and 2 years
           of trainee or equivalent experience.  (A "limited" trainee
           must have one year of experience in the designated specialty.
           in addition to a baccalurate.)

        .  Bioanalyst:  requires a master's degree and 4 years of experi-
           ence as a technologist.

        .  Clinical Chemist or Microbiologist:  requires a master's de-
           gree and two years of experience in the designated specialty.
                                  39

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        Qualifying written examinations are always required and
        oral and/or practical examinations may also be given.

     .  Although the agency does not itself conduct a proficiency
        testing program, it requires that licensed laboratories,
        as well as those operated by physicians in their offices,
        participated in such a program approved by the agency.
        These approved programs include those administered by the
        College of American Pathologists, American Association of
        Bioanalysts, California Society of Internal Medicine and
        Center for Disease Control.

     .  Laboratories participate in proficiency testing on a
        quarterly basis.  The testing program provides both the
        data and evaluations to the State agency.  In the event
        of two consecutive "bad" results, the laboratory is re-
        quested by the State to discontinue the provision of
        services in the "failure" area.  Services may be resumed
        after two consecutive "good" results which, presumably,
        indicate that appropriate corrective measures have been
        taken.

     .  Except in the case of Medicare laboratories, site visits
        are made every five years.  In the former case they are
        annual.

     .  State inspection and licensing officers have the title
        Examiner, Laboratory Field Services.   These are licensed
        laboratory technologists who have received additional
        on-the-job training.

     .  The State receives Federal reimbursement for the approval
        of about  800 Medicare  laboratories at  the  rate of approxi-
        mately 50% of actual cost.  This amounts  to $500,000 annually,
        which  implies a  total  program cost approximating $1,000,000.

Opinions Expressed

(Lack of adequate funding resources was cited  below as  the  root cause of
some of the problem areas identified below.)

     .   Ideally,  each  laboratory should be visited annually,  as
        is the case with Medicare laboratories.   The time required
        per site  inspection ranges from a minimum of four up  to
        eight  hours, depending on the size of  the facility.   At
        present,  visits  may not be any  more frequent than once every
        five years.

     .   The agency cannot satisfactorily  review and maintain, on a
        current basis,  the data that it receives from the various


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        approved proficiency testing programs.   Aside from insuf-
        ficient availability of statistical  services, the agency
        is dependent on another unit within  the Department of
        Health for such computer service as  it can acquire and
        which, it considers, is grossly inadequate for its needs.

     .  Due to the lack of sufficient State  personnel, the agency
        cannot enforce the requirement that  physicians'  office
        laboratories participate in proficiency testing programs.
        Of the estimated 8,000 such laboratories, it is believed
        that probably no more than 500 are actually in compliance.

Certified Laboratories (Solano Laboratories, Bio Research Laboratories)

(Note:  Two laboratories, representing extremes of scale, were selected
in order to ascertain differences of viewpoint reflecting facility  size
as such.  Bio Research Laboratories is a small, independent laboratory
with a staff of four or five.  Though once quite profitable and a pio-
neer in mail order clinical laboratory services, it now appears to  be
well on the decline and fading.  Solano Laboratories, on the other  hand,
is a large operation embracing eight separate licensed laboratories with
a total staff of approximately 150.)

Factual Information

     .  Mo significant additional information about the California
        program emerged during the interviews with these laboratories.

Opinions Expressed

     .  Size, with the attendant economy of  scale, is considered
        to be a critical  factor in a successful  operation.   The
        small independent laboratory cannot  afford automated
        analytical  equipment and is thus at  a tremendous com-
        petitive disadvantage.   (Hospital  clinical  laboratories
        having hospital patients as their clients, are essentially
        free of such competition.)

     .   Many of the observations made by both laboratories  related
        to the difficulties experienced in operating within the
        regulatory framework.  The following specific points were
        made in this connection:

               Successful  laboratories tend, increasingly,  to
               conduct mail  order operations across  State lines.
               This often requires multiple  licensing by States
               as well  as licensing by the Federal  government.
               In consequence,  there is considerable duplication
               of effort  which, it is felt,  actually provides
               little benefit to the public  and  none to  the labora-
               tory.

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 California  requires  different  licenses  for  different
 types  of laboratory  operation  and  these are admini-
 stered by separate agencies within the  State Depart-
 ment of Public  Health.   General clinical  laboratory
 licensure falls under  the authority of  Laboratory
 Field  Services.   Licensure for radiological  proced-
 ures is controlled by  the Radiological  Health Section.
 Licensure for alcohol  and methadone testing falls
 under  the Clinical Chemistry Laboratory and testing
 for PKU (phenylketonuria) involves the  Family Health
 Services Section.  Each  of these agencies has dif-
 ferent forms, different  procedures and  different per-
 sonnel.   In addition,  the licensing processes under
 each program may require separate  site  visits and
 evaluations.

 Proficiency testing  programs required both  by the
 State  of California  and  by the Federal  government
 are found costly, in terms of  both the  service fees
 and the time required  for the  analyses.  For  a small
 laboratory, such as  Bio  Research,  this  cost is a
 significant fraction of  its total  operating expense.
 In the case of  a  large laboratory,  such as  Solano,
 the economic impact  is relatively  unimportant, but
 the sample  frequency is  objectionably high  (almost
 weekly for  Solano).  Of  greater concern (to Solano)
 is the delay which is often experienced in  receiving
 proficiency results  so that indicated deficiencies
 can be corrected.  It was stated that such  delays
 may extend  to six months.  It was  also noted  that,
 for the  same proficiency testing sample, the  State
 and Federal  agencies may have different standards
 of acceptability.

 A major  focus of criticism was the  lack of adequate
 regulation of physicians' office laboratories.  These
were represented as  severely requiring greater formal
 supervision and control.   For example, about  10 to 12
 percent of the total  of Solano Laboratories technical
operation is directed to internal  quality control
activities.   Office  laboratories,   in contrast, may
 spend no time whatever on quality control.

On the positive side, the interviewees at both labora-
tories  agreed that the public is  better served because
of licensing requirements.   While the  system is  re-
garded  as far from perfect,  it is  believed that  State
regulation has considerably  reduced the frequency  of
poor (incorrect) data.   Also,  from the laboratory
                    42

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               viewpoint, the licensing of personnel  provides the
               facility with better qualified job applicants.

               In relation to the possibility of certification or
               licensure of environmental  monitoring  laboratories,
               it was suggested that any such program should avoid
               duplication of effort within a State,  between States,
               and between State and Federal controls.  Rather, a
               single State regulatory system was recommended, with
               reciprocity among States and operated  under Federal
               guidance.

PRIVATELY OPERATED

American Industrial Hygiene Association
  Program:Accredits Industrial Health Laboratories

Certifying Entity

Factual Information

     .   This program, has, since its inception, operated under
        the sponsorship and support of the National  Institute
        of Occupation Safety and Health (NIOSH) which, originally
        directly conducted all  proficiency testing in behalf of
        the American Industrial Hygiene Association (AIHA).  Pro-
        ficiency testing operations are now contracted to  a  private
        firm (Hyland Laboratories).

     .   The current standard for laboratory qualification under the
        proficiency testing portion of the program requires  that
        results fall within +_ 3 standard deviations of the target
        value.

     .   Feedback of proficiency testing results is provided  to the
        laboratories by NIOSH.

     .   AIHA is responsible for facility and personnel evaluation.
        Prior to inspection, a  "Pre-Site Questionnaire provides both
        for general information which is substantially independent
        of the particular area(s) of laboratory activity and for
        specifics relating to air sampling, bioassay  and so  forth.
        Academic qualifications and required experience are  set
        forth for four categories of laboratory personnel  which are:

               Laboratory Director (preferably, a Dipi ornate  of the
               American Board of Industrial Hygiene).

               Laboratory Supervisor (Doctorate in a  relevant science
               or an M.D. with  two years experience.   Lesser degrees
               coupled with more experience are acceptable.)

                                 43

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               Industrial Hygiene Technologist (baccalaurate)

               Industrial Hygiene Technician (high school graduate
               with two years experience, or two years in an ac-
               credited college which includes at least one course
               in analytical chemistry).

Opinions Expressed

     .   Although the program is too new to evaluate adequately, labora-
        tory performance, based on results of proficiency testing
        data, collectively shows a trend toward improvement.

     .   Specific program benefits cited were:

               Laboratories are now more selective in the hiring
               of new personnel.

               Laboratory supervisory personnel seem more induced
               to take courses in environmental health sciences.

     .   Program modifications considered desirable were:

               Extension of the proficiency testing program to
               include sample acquisition and transport procedures.

               Inclusion of the requirement that all  laboratory
               personnel be certified by either the American Board
               of Health Physics or the American Board of Industrial
               Hygiene.

Certified Laboratory (Maryland State Department of Health and Mental
  Hygiene, Occupational Health Laboratory)

Factual Information

     .   This interview did not elicit any previously unkown facts of
        significance relating to the AIHA program.  The Occupational
        Health Laboratory is primarily in industrial  hygiene and air
        quality procedures and performs analyses for the  Maryland
        State Air Quality Laboratory.

Opinions Expressed

     .   It was stated that the Occupational  Health Laboratory had
        been too recently accredited to permit an adequate analysis
        of the effects of the program on the laboratory.   Neverthe-
        less, it was believed the proficiency testing portion of the
        program, which is conducted every two months, has resulted
        in improved laboratory data quality.
                                 44

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     .  It was felt that AIHA could improve the program's usefulness
        through the following:

               Preparation and updating of a master list of all
               commercial laboratories accredited under the program.
               This list would classify the laboratories on the
               basis of the analytic and test categories in which
               they are qualified.

               Establish and maintenance of a central  register of
               trained laboratory personnel, indicating specialty
               areas of competence.

               Establishment and operation of training seminars
               in sample handling procedures.  (This is an area
               which AIHA recognizes as important and  highly criti-
               cal.)

     .  The Occupational Health Laboratory has experienced consid-
        erable difficulty in maintaining a satisfactory internal
        quality control program because of inadequate  staffing.
        (The annual budget is too low to permit expansion.)

College of American Pathologists
  Program:  Accreditation of Clinical  Laboratories

Factual Information

     .   The College of American Pathologists (CAP),  founded in 1947
        and now consisting of over 6,000 Board certified pathologists,
        conducts a laboratory accreditation program  under the author-
        ity of the Center for Disease Control  (CDC).   The CAP program
        is reevaluated each year by CDC which audits about 10% of CAP
        approved laboratories.

     .   Laboratories are initially qualified through an on-site in-
        pection which is repeated on an annual  basis.   On-site visits
        are performed by volunteer pathologists who are reimbursed
        for their expenses only.   These pathologists are provided
        with detailed check lists which are designed to aid in ob-
        taining an objective evaluation.   Approximately 1,200 to
        1,300 laboratories are  inspected  each  year.

     .   Three of four workshops  or seminars are conducted  annually
        in each of CAP's ten regions for  the purpose of training
        laboratory inspectors.   The subjects treated include  such
        matters as changes in the law  and  field problems  typically
        encountered.   Laboratory personnel  are free to  attend  these
        sessions.
                                 45

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Proficiency testing is conducted on a quarterly basis,
using split samples.   Consecutive four quarters of un-
satisfactory results  by a laboratory is used as the basis
for delisting in the  particular analytic area in which
its performance was unsatisfactory.

CAP conducts several  levels of programs as follows:

       The "Basic" program, which is designed for the small
       hospital or independent laboratory, meets Medicare
       and most State licensure requirements.  However,  it
       is not accepted by CDC.

       The "Comprehensive" program is consistent with the
       Clinical Laboratory Improvement Act of 1967 and  the
       requirements of CDC in the areas of clinical chemistry,
       hematology and blood banking.  It does not, however,
       meet the requirements for interstate licensure in the
       areas of mycobacteriology, parasitology, mycology and
       serology.

       The "Special"  program is designed to meet the above
       requirements in microbiology, serology and toxicology.
       This "Special" program is reviewed each year in  a
       meeting between CAP and CDC administrators.

Two major differences between the CDC and CAP programs

       The CAP program uses the services of volunteer path-
       ologists for laboratory inspection, as stated above.
       CDC has a full-time staff for this purpose, each
       member of which is an experienced clinical laboratory
       technician.

       The CDC distributes its reference samples to a group
       (10 to 20) referee laboratories.  The results of analy-
       ses performed  by these laboratories are then used as
       the basis for  arriving at the mean values of the samples.
       CAP, on the other hand, uses the results of the  partici-
       pating laboratories to determine the sample mean values.

CAP offers a variety  of services to clinical laboratories
independently of its  accreditation function as follows:

       Under the Proficiency Evaluation Program (PEP),  the
       laboratory may be assessed in terms of performance
       without being  accredited.  About 700 laboratories
       have enrolled  in this program.
are:
                          46

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               Under the CAP Quality Assurance Service (QAS),
               a laboratory may submit its daily quality control
               data on a weekly basis.  This data is reduced by
               CAP and a computer print-out returned to the
               laboratory.

               CAP publishes a variety of laboratory guides and
               manuals such as "Standards for Accreditation of
               Medical Laboratories," a "Survey Data" series which
               relates to PEP, "Management of Your Quality Control"
               and "Laboratory Instrument Maintenance and Function
               Verification".

        CAP operates programs for the V.A. Hospital  system, Army
        hospitals in North America and Europe, Navy Hospital in
        the continental  United States and for all U.S. Air Force
        hospitals.  At present, 38 States accept CAP programs as
        the basis for licensure.
Opinions Expressed
        CAP considers its principal  objective to be the upgrading
        and improvement of the clinical  laboratories operating under
        its programs.

        Major problems have been:

               Obtaining personnel  to perform inspections.   (It
               is estimated that the use of full-time personnel
               would add $400-$500  to the annual  expense of each
               participating laboratory.

               Inducing more laboratories to participate in the
               program.

        CAP is acutely aware that the CDC program is markedly  less
        expensive (for the participating laboratories)  since the
        latter is Federally subsidized.   Thus,  CAP officials con-
        sider that they are competing with the  Government on an
        unfair basis.   However,  they also feel  that the competition
        between the program is,  in general,  productive  of better and
        more effective laboratory operations.   They maintain,  though,
        that CDC's fee structure should  more accurately reflect its
        program costs.

        CAP believes that,  in  general, laboratory accreditation
        programs  establish  and track the level  of proficiency  of
        the laboratory categories to which they are directed.  Spe-
        cifically,  they believe  that the evidence supports  their
        view that the CAP  program has significantly upgraded the

                                 47

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        level of performance of the average laboratory partici-
        pating in it.

Certified Laboratory (Fairfax Hospital  Laboratory, Fairfax County,  Va.

Factual Information

     .   The Fairfax Hospital Laboratory (FHL)  is licensed under
        the CAP Program and qualified in all  areas.   This labora-
        tory is relatively large, well  organized and has partici-
        pated in the program since 1967.

     .   During CAP program inspections, procedure books are checked,
        some techniques are monitored and reagent storage and main-
        tenance practices are examined.  In addition, general house-
        keeping, records and safety conditions and procedures are
        checked.

     .   The proficiency testing samples, which are received
        quarterly, are not treated separately, but are combined
        with the day's regular work.   Care is  taken, however, to
        have different personnel, if possible, perform the analy-
        ses each time in order to assure that  the proficiency
        testing evaluates a cross-section of the laboratory staff.

     .   FHL maintains a full-time Quality Control Section which
        maintains all of its records at a central location.   This
        Section, which is primarily responsible for monitoring the
        performance of each laboratory  department, also checks
        equipment to assure that it is  operating within its stated
        parameters.

Expressions of Opinion

     .   Although the workload imposed by the CAP program is both
        considerable and expensive, the program is strongly sup-
        ported by the laboratory staff.  It is believed that the
        program has proven beneficial in two key respects:

               Management has been made more aware of the necessity
               for supporting the overhead functions and equipment
               relating to the Quality  Control  Section.

               Operating personnel  are  more easily motivated to
               perform quality work.

     .   Most of the deficiencies received by the laboratory involve
        housekeeping and safety areas and frequently involve matters
        considered trivial.   It is  felt that minor areas which do not
        affect the quality of performance or the basic safety of the
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        staff should be deemphasized during inspection in order
        to permit more attention to be devoted to substantive
        factors.

     .   The laboratory staff feels that no responsible laboratory
        can operate without a full-time Quality Control  Section.
        It also believes that all laboratories should be licensed
        or accredited.  They maintain that, in general,  non-accredited
        laboratories usually lack internal quality control  systems and
        do not display as high levels of performance (as accredited
        facilities).

Summary

Although an appreciable diversity of program detail  and  individual opin-
ion was encountered during the Phase II portion of the study, there were
clearly identifiable areas of agreement among those interviewed which
were essentially independent of the character of the laboratory opera-
tions involved ((water, clinical medical, etc.).  The following summar-
izes those findings and viewpoints which appeared to be  most pervasive:

     .   Program deficiencies and inadequacies usually reflect, or
        at least seem attributable to, insufficient funding.

     .   Program operating cost information was usually found not
        to be available, especially in terms of specifics.

     .   Program officials consider, for the most part, that the
        laboratories operating under their jurisdictions exhibit
        improved performance and data quality.

     .   Program benefits most frequently identified  by the  personnel
        of laboratories operating under them include:

               Improved operation and data accuracy.   This  is
               usually attributed to proficiency testing re-
               quirements.

               The provision of a basis for upgrading  and augmenting
               laboratory equipment.

               Improved morale of laboratory personnel.

               The exclusion (or at least the basis  for  exclusion)
               of incompetent competition.

     .   Program problem areas most frequently cited  by the  laboratory
        officials are:

               Costs (in terms of both money and personnel  time)
               expended in  maintaining compliance with program
                                  49

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               requirements.  This applies particularly to pro-
               ficiency testing.  These costs, which can be econ-
               omically quite burdensome to small laboratories,
               are usually easily tolerated by large organizations.

               Delays in receiving the results of proficiency test-
               ing analyses and, therefore, in the adoption of cor-
               rective measures where deficiencies have occurred.

               Inadequacy of general program information from the
               certifying organization to the laboratories.  (This
               criticism by no means applies to all programs re-
               viewed.  CAP, for example, provides outstanding in-
               formational services to its participating laboratories.)

               The on-site laboratory inspection process frequently
               directs too much effort to details (such as house-
               keeping practices) which are considered extraneous
               to the basic laboratory operations.

Synopses of all programs studied under Phase II are presented in Appen-
dix I.  (Most of the program synopses shown were originally developed
under Phase I.)  Samples of the various forms used in the certification
programs appear in Appendix II.


Phase III:  Progam Option Identification and Assessment

Methodology

As indicated in the Introduction, the overall certification process was
separated into a number of key constituent administrative and procedural
elements for which alternative approaches were then identified and  assessed.
The selection of the particular elements examined was based on certain
considerations which were determined by the objectives of this study and
others which reflected various relevant features of EPA's organization
and operation.  Among the more important of these considerations were:

     .  The purpose of this study, as previously  stated,
        was the consideration of environmental monitoring labora-
        tory certification from a policy oriented viewpoint,
        rather than in terms of technical program specifics
        (such as laboratory evaluation criteria, for example).

     .  EPA's basic approach to the implementation of environ-
        mental enhancement and protection is programmatic (that
        is, the Agency's activities which impinge directly on
        the environment are organized and, to a large degree
        separately administered, as air programs, water programs,
        pesticide programs, and so forth).
                                 50

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      '   Major  environmental programs  (such as transportation
         control  plans designed to ameliorate air  pollution
         and  areawide waste management plans, for  example) are,
         for  the  most part, implemented through State agencies.

      .  As noted earlier, EPA's Quality Assurance operations already
        includes an Inter-laboratory  Program.  This program is still
        in its developmental  phases and has, so far, directed its ef-
        forts largely to site inspection based evaluations of EPA
        (and, to some extent, State)  laboratories as well as to cooper-
        ative inter-laboratory activities relating to the assessment
        of new analytic procedures and methods.   It is clear, however,
        that with adequate support this Program could be expanded to
        provide the evaluatory and other technical functions required
        for the establishment and operation of a  laboratory certifi-
        cation process.

In addition to the above, three basic premises,  or assumptions were
formulated which are believed to  be realistic and which underlie much
of the subsequent analysis.

The first premise is that it would be extremely difficult, if not
actually impossible for  EPA to provide, in a single step, all
resources required for the establishment of a comprehensive labora-
tory  certification program as well as to assure the future provision
of these resources for its maintenance.

The second premise is that, over the  long term, EPA's policy will fa-
vor the extension of its Quality Control  and Inter-laboratory Programs
to include, directly or  indirectly, all laboratories generating environ-
mental monitoring data.  This assumption is based on the obvious require-
ment  for the comprehensive (that is,  on national  basis) upgrading of en-
vironmental data quality.  However, a very large proportion of the en-
vironmental data produced for such purposes as air and water quality
status and trends analysis, as well as for compliance monitoring, is
produced by county, municipal and private laboratories.  A QA program
which did not ultimately plan to include such facilities in its opera-
ting  scope would appear  to be of limited long run value to the Agency.
The third premise, which is to some  extent implied" by  considerations
inherent in  the  second,  is that  EPA will  extend  with  the QA  program
independently  of whether or not  certification is  implemented.

The above considerations and  premises were important factors  which
played contributory roles, in many  instances, not only in respect  to
option formulation, but  also  in  shaping the  evaluatory framework
within which  these options were  assessed.  For example,  the prospective
benefits  and costs of certification were considered from an incremental
standpoint because of the already existing QA program.   Clearly, in  the
absence  of this  program  as a  basis,  the magnitude of the effort and
resources required for establishing  and conducting a laboratory certifi-


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 cation  operation would  be  far greater.   In this connection, it should
 be pointed  out  that  EPA's  position  is rather unique with respect to
 that  of other organizations which have  instituted laboratory certifica-
 tion  or approval programs.  In  nearly all instances, it was necessary
 for these organizations  to develop  and  organize the mechanisms required
 for implementing laboratory inspection  and evaluation procedures as
 well  as proficiency  testing programs.   EPA obviously enjoys a consider-
 able  advantage  in  that  these mechanisms  already exist within the Agency
 in operating form.

 Analysis

 The certification  options  presented below relate to various key pro-
 gram  administrative  and  procedural  areas which, because of the nature
 of the  considerations involved, present themselves as issues to be
 resolved or as  critical  questions requiring answers before a recom-
 mended  course of procedure can  be formulated.  In the presentation
 which follows,  each  such issue  is identified and alternative approaches
 are set forth.  These approaches, which constitute the program options,
 are then assessed  in terms of their pros and cons.  In this context, it
 is pointed  out  that  this study  was  oriented to the examination of
 possible environmental  laboratory certification by EPA from a "feasi-
 bility" standpoint.  In  a  general sense, the accomplishment of any
 objective,  not  inherently  unachievable,  is "feasible", provided that
sufficient resources are made  available.  In  the  context  of this  study,
the term "feasibility"  is interpreted  in a  relative sense in  that a
given  method or approach can  be spoken of as  "more feasible"  than
another if it presents  a smaller aggregate of expected  economic costs
and procedural  difficulties.   It follows, therefore,  that equally
"feasible" or "practicable" approaches to the same problem may differ
among themselves,  depending on the trade-offs made between economic
and procedural  factors.   The  analysis  presented below was developed
within an orientation in which the minimization of procedural diffi-
culty was considered of no  less importance than the minimization  of
funding requirements and in which the  presumptive benefits of certi-
faction  (to EPA) were not compromised.


 The position taken in this study, which considers formal laboratory
 certification as a distinct and incremental process in relation to the
 evaluatory  activities of the existing QA program, has already been
 expressed in general terms.  Because of the fact that option formulation
 and analysis were  in some  instances shaped or influenced by this
 position, it is appropriate to  examine  the concept somewhat more
 searchingly.  "Formal certification", as the expression is used in this
 report,  relates to all accreditation or approval  procedures other than
 those directly concerned with the actual evaluation of laboratory
 capability  and performance.  It includes such functions as application
 review,  assessment of laboratory evaluation results in terms of
                                  52

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certification standards and criteria, notification of certification,
notification of deficiencies and similar procedures.  (This functional
distinction is not as clearcut in all certification programs.  However,
the American Industrial Hygiene Association, for example, maintains an
"accreditation committee" which makes the formal decision of whether or
not to certify, based on evaluatory information received, but which is
not directly involved in the acquisition of this information.)  It
should be noted that the EPA element administering and implementing the
"formal certification" process will, almost inevitably, bear a con-
siderable share of the liability for any adverse consequences stemming
from its decisions.  This consideration is the key reason underlying
the stress placed on the distinction, which might otherwise appear
trivial, between the "formal certification" process and the administra-
tion and performance of the evaluatory procedures on which it would be
based.  (Throughout this analysis, it is, of course, assumed that,
regardless of the mode of implementation of the "formal  certification"
mechanism which is optionally presented, the responsibility of the EPA
QA program for the administration and conduct of certification-related
evaluatory procedures would remain unaffected.)

(Note:  Wherever the terms "certification program", "certification
process",  or "program" appear in the following analysis,  they should
be understood to refer only to the formal  aspects of certification
as described above, unless otherwise indicated.)

Issue I  Mode of Program Management

This issue concerns the question of whether EPA should manage the
program itself or with support from another entity or whether it
should delegate administrative and operational  responsibility to
another organization.

     Formulated Options

        Option A

           EPA,  under  contractual  agreement with a  qualified  entity
           (such as an organization now  conducting  a  similar  program)
           delegates responsibility for  program management and opera-
           tion.

        Option  B

           EPA  manages  program  directly  with on-going  contractual
           support  which  provides  advisory  services and/or qualified
           personnel for  the performance of specific functions.
           (Note:   Other  possible  types  of  support, such as the  pro-
           vision of microbiological reference  samples which has been
           proposed  by  CDC,  would  relate to  EPA's QA program rather
           than  to  the  certification process as defined.)
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   Option C

      EPA manages and executes the program directly,  without a
      long-term commitment to another organization for con-
      tractual  support.   Such support is to be procured only when
      specific  needs for it arise.

Option Assessment

   Option A

      Pro
          EPA would acquire the services of already developed
          expertise for operating the program and would avoid
          the need for either acquiring additional personnel or
          detaching current personnel from other duties in order
          to staff the program.  It would also eliminate the
          requirement for managerial involvement in program
          operation.
      Con
          Inasmuch as the program would probably be invested with
          legal  and regulatory force and,  furthermore, would
          almost certainly involve inter-governmental  relations,
          the prime agency (EPA) should retain both program
          authority and managerial control.   [In any case it is
          unlikely that, if (theoretically)  program management
          were to be delegated, EPA would  be substantially
          relieved of liability for any consequences of mismanage-
          ment by an agent].

          Some EPA personnel  might feel that they were being
          dictated to by an "outside" group  or that some of their
          rightful functions  had been, so  to speak, usurped.  In
          any case, the real  possibility of  inter-organizational
          friction cannot be  dismissed.
   Option B

      Pro
          The advantages of Option B are similar to those of
          Option A without the problems inherent in the delegation
          of program management.

      Con
          At the beginning of the program it will  be quite
          difficult to foresee the nature,  severity and number of
          problem areas EPA may encounter in the course of program
                             54

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               development and operation.  It is entirely possible that
               difficulties may appear only sporadically and that a
               long-term commitment to contractual support could prove
               unjustified.  Furthermore, the findings of this study
               strongly suggest that guidance and help from established
               organizations with laboratory certification experience
               at Federal, State and private levels would be freely
               available when needed.

        Option C

           Pro
               This option offers the advantage of intra-agency program
               authority and control without long-term commitments to
               other entities.

           Con
               There are no significant disadvantages seen for this
               option.  However, some staff additions would probably
               be required.

     Conclusion

        Option C is preferred.

Issue II  Assignment of Intra-agency Program Responsibility

This issue, which inherently assumes the rejection of Option A,
Issue I, deals with the consideration of where,  within EPA, should the
responsibility for program administration and performance reside.   The
basic question involved here is whether this responsibility with its
attendant implications should be borne by the Quality Assurance staff
or whether a new EPA element should be established to assume it.

     Formulated Options

        Option A

           All administrative and procedural  components  of the program
           would be assigned to the QA program.   Within  the broad
           scope of this there are two major sub-options:

               .   Formal certification authority is  vested in  the
                  Regional  Quality Control  Coordinators,  or equivalent
                  officials.

               .   Program management is centralized,  with  certification
                  authority assigned to centrally reporting field
                  personnel.
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   Option B

      An independent element is established within EPA with
      assigned responsibility for administration and operation
      of the program.  As in Option A,  sub-option (2) above,
      certification authority would be  vested in centrally
      reporting, regionally assigned field personnel.

Option Assessment

   Option A

      Pro
          Administratively, it would appear simpler to assign an
          added function to an entity already existing within the
          Agency than to establish a new organizational  element
          for its implementation.  Further, without doubt either
          the necessary capability and  staff expertise could  be
          wholly supplied by existing QA organization personnel
          or, if necessary, could be supplemented through the
          acquisition of appropriately  qualified individuals.   In
          addition, the laboratory certification process is so
          closely linked to the procedures for establishing
          facility qualification that it seems "natural" to
          incorporate the program within the QA operating
          structure.   Of the formulated sub-options,  (2) appears
          preferable because centrally  reporting personnel  would
          be more immune to local pressures than a regional staff
          and because centralized management is inherently
          conducive to the establishment and maintenance of pro-
          cedural  uniformity.

      Con
          The major reservations with respect to Option  A stem
          primarily from the fact that, in assuming direct
          responsibility for laboratory certification,  the QA
          operation would,  as  previously mentioned, quite possibly
          find itself a vulnerable target in event of any
          unfavorable consequences of its actions under  the pro-
          gram.   There is an additional  and somewhat more subtle
          consideration involved in this issue which concerns
          the relationships between EPA's QA inter-laboratory
          program and both current and  future non-EPA partici-
          pating laboratories.   This  program is geared,  essentially,
          to the upgrading  of  laboratory capability and  performance
          in the interests  of  enhancing the quality and  reliability
          of the environmental  data generated.   The success of
          this program will  in  large  measure depend on the
          establishment and maintenance of cooperative and
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          harmonious working relationships between EPA QA personnel
          and the staffs of the non-EPA participating laboratories.
          It is probable that this cooperation and harmony may be
          more effectively maintained under conditions in which the
          identification of the QA staff with actions having associ-
          ated regulatory and legal  implications  is minimized to the
          degree possible.  Another consideration which is relevant
          in this context is the following:   Laboratory certification,
          as the term is used in this study,  is to be interpreted as
          meaning no more than the formal  recognition that a facil-
          ity has been found to meet certain  standards of capability
          and performance.  On the other hand, the QA program,  which
          is addressed to the more or less indefinite improvement
          of the laboratory operations,  would not consider that
          a  facility, merely because it  had  satisfied defined cer-
          tification requirements, should  no  longer be encouraged
          and aided in further upgrading the  quality of its per-
          formance.  Accordingly,  the objectives  of the QA Inter-
          laboratory Program and those of  certification are quite
          different in the same sense that the goal  of unconstrained
          data quality enhancement is quite different from the  goal
          of establishing and maintaining  threshold  standards for
          determining data acceptability.  Because  of this,formal
          certification  and the Inter-laboratory  Program can  be
          regarded  as wholly disparate activities and organizational
          separation of  the former function from  the QA program
          should in no way compromise QA's interests  and actions.
   Option B

      Pro
          This option, which in terms of the internal operation it
          suggests, resembles that of Option- A, sub-option (2),
          provides the additional  feature of keeping the operations
          of the formal certification process independent of those
          of the QA program.  The advantages of this separation
          are identified in the above discussion.

      Con
          The organization separation of formal certification
          authority and responsibility from the pre-certification
          and certification maintenance evaluatory procedures
          could, in occasional  instances, induce inter-department
          conflict.

Conclusion

   It is considered that option selection in this instance would


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        reflect a management decision which lies outside the scope of
        this study.  In addition, some of the reservations with
        respect to Option A also could be met by establishing a
        certification entity within the QA framework which would be
        administratively independent of the inter-laboratory program.
        This would provide the purely technologically oriented QA
        operations with a considerable measure of immunity to the
        regulatory aspects of the certification while, at the same
        time, permitting closer coordination between laboratory
        evaluative processes and the formal approval process.

Issue III  Programmatic vs Unified Certification Responsibility

This issue relates to the question of whether laboratory certification
should be administratively organized and implemented on a programmatic
basis (implying, for example, separate certifying officers for air and
water laboratories) or whether it should be conducted within an
integrated entity whose staff would bear cross-programmatic responsi-
bility.

     Formulated Options

     In  this case the options are clearly defined in the statement
     of  the issue as:

        Option A

           Organization on a programmatic basis

        Option B

           Organization on a comprehensive basis

     Option Assessment

        Option A

           Pro
               Fragmentation of certification  responsibility along
               programmatic lines  would  permit more  intensive
               specialization on the part of certification  officers.
               This would  be conducive to a  more detailed understanding
               of the technical  factors  relevant to  their responsi-
               bilities.

           Con
               Programmatic organization  would  require  far  more
               personnel and  would  substantially increase the cost of
               program  operation.   This  system  might also prove
               unwieldly in certain  respects.   For example,  a given


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               laboratory might perform analyses  of environmental
               samples relating to more than one  program.   Under  this
               option, dual  certification by different authorities  of
               the same agency would be required  in such a  case.
               (Note:   This  is not the same as  separately certifying
               a laboratory  for more than one category of test or
               analytic procedure under a single  authority).

        Option B

           Pro
               A unified, cross-programmatic certification  system is
               far easier and less costly to administer and to imple-
               ment.   This form of organization is judged to be
               feasible.  For example, the HQ QA  Division operates
               cross-programatically in many areas (including facility
               evaluation) as do various regional Quality Control
               Coordinators.  (It is also noted that certification
               officers would obviously have to have only reasonable
               comprehensive understanding of the operations of the
               laboratories  under their jurisdiction.   The  depth  and
               scope of technical information and insight required  for
               the satisfactory performance of  their function would be
               substantially less than that needed for the  performance
               of evaluatory operations.)
          Con
              There are no significant disadvantages seen associated
              with this option.

     Conclusion

        Option B is preferred.

Issue IV  Certification Program Depth

If the certification program is to achieve its  objective  of ultimatley
assuring that environmental  data reported from  all sources  will meet
designated reliability criteria, the program must obviously encompass  all
laboratories engaged in environmental monitoring  activities.   The issue
that arises here is whether EPA should directly certify all such
laboratories, or whether the Agency should certify only to  the State
level, with State agencies assuming responsibility for the  certification
of interstate laboratories (such as municipal,  county, private and
industrial facilities.)  (Note:  The latter option is  not the same  as
Option A of Issue I under which total program responsibility would  be
delegated.)

     Formulated Options

        Option A

           Under this  option EPA would certify  both State and intra-
                                   59

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      state laboratories directly and would also assume responsi-
      bility for the laboratory and procedural  evaluation.

   Option B

      EPA would evaluate and certify State laboratories directly.
      The State agencies would then evaluate and certify intra-
      state laboratories, acting either under EPA delegated
      authority or that conferred by State statute.   Standards
      and criteria would be uniform for laboratories at all
      levels.

Option Assessment

   Option A

      Pro
          Direct certification by EPA of all  environmental
          laboratories would maximize the probability of attaining
          uniformity of standards and procedures, since all
          laboratory evaluations would be performed  by the  QA
          staff.   The Agency would acquire a firmer  control of
          environmental  laboratory operations than would be
          possible through certifying intermediaries.

      Con
          The  findings of this study show that  an announced
          intent by EPA to directly certify intra-state labora-
          tories would trigger a considerable amount of State
          objection and resistance.   State agencies  would seriously
          resent such an action because it would be  seen as an
          invasion of their prerogatives.   EPA/State relationships
          which may be already stressed in some instances,  would
          be seriously damaged.   (This conclusion is based  on
          interviews conducted with a number of environmental
          agency officials in various States.   Their views  were
          unanimously those indicated.   This  sample  obviously does
          not  imply, however, that the conclusion is necessarily
          true of all  States.)

          It would be necessary for EPA to augment its  QA staff by
          a significant amount and also to provide for  a substan-
          tially larger than otherwise certification operation in
          order to provide adequate evaluatory  and approval  ser-
          vices to all  environmental  laboratories (there are
          thousands in the 50 States).
   Option  B

      Pro
          This option has the overall merit of being politically


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               far more procedurally feasible than the alternative.
               EPA certification program staffing requirements would
               be small and the laboratory evaluatory procedures should
               be accommodated with little additional burden on the  QA
               inter-laboratory program resources.

           Con
               Many States lack the personnel and other resources
               necessary to conduct the facility evaluation procedures
               which are prerequisite to formal  certification.  In
               other cases, in which State certification programs
               already exist, there are likely to be differences
               between State standards and criteria and those which
               EPA would formulate.  These problem areas, which are
               admittedly significant and are discussed later in this
               report.

     Conclusion

        Option B is preferred in spite of its attendant problems.

        Option A is considered politically inadvisable.

Issue V  Programmatic Timing and Range of Certification

The issue referenced here relates to the programmatic scope of labora-
tory certification and, perhaps more importantly, to the question of
whether certification should be implemented by program successively
or on a simultaneous basis.  This study takes the position that it is
a foregone conclusion that laboratory certification must, as a minimum,
include facilities engaged in air and water analyses and probably, in
the long run, those involved in certain areas of pesticide and radiation
measurements as well.  However, in terms of actual laboratory operations
as encountered, there tends to be some degree of "programmatic" over-
lapping in that air and water sample analyses may be conducted by
different departments of the same facility.  Further, at least from
the vantage point of this study, there would be some degree of artifi-
ciality in distinguishing water analyses addressed to non-pesticidal
organic toxic pollutants as opposed to those which directly relate to
pesticide determinations performed by the same facility, even though
a "programmatic" distinction is possible on a semantic basis.  In view
of EPA's prospective expanded responsibility with respect to the
surveillence and protection of drinking water quality, it seems
appropriate to express the view of this study to the effect that, in
terms of the QA program, as well as in the context of possible
certification, water supply testing laboratories should not be treated
separately or in a different manner from those engaged in effluent or
ambient water analyses.  In fact, in many cases  the same facility is
active in both general areas.
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In spite of the above consideration that in some instances there may be
a degree of blurring of inter-programmatic boundary lines in terms of
monitoring and QA related operations, Issue V remains essentially valid.
The position taken in this study with respect to one aspect of this is-
sue is that the establishment and implementation of a certification plan
which would address all programmatic areas simultaneously is a far less
realistic option than one based on successive programmatic steps.  How-
ever, a case can be made in favor of the simultaneous approach on the
grounds of desirability as follows:

     .  It would shorten the time required for attaining certification
        of laboratories active in all programmatic areas.

     .  It would require the consideration of all  program specific
        technical and administrative issues during the developmental
        stages of the certification program within the context of a
        single, unified planning operation and would thus possibly
        reduce the need for subsequent major program modifications
        which might otherwise be required.

The key arguments against the simulataneous approach are:

      .  An attempt to  implement a certification system embracing
        all EPA programmatic monitoring areas at once would prove
        not only extremely costly, but because of the relative
        inexperience of the Agency in the certification process, an
        extremely complex burden for the responsible staff.

     .  The degrees of relative "maturity" of monitoring and QA
        operations are notprogrammatically uniform.  Available
        pesticide data for some media is relatively slight compared
        with that developed under air, water and radiation surveillance
        programs.

     .  The pressures underlying the requirement for reliable
        monitoring data are different with respect to the various
        programs and this suggests that needs should be prioritized.
As stated at the beginning of this discussion, the certification of
laboratories engaged in air and water analysis is regarded as an
irreducible minimum program.  Later extension to radiation and radio-
nuclide monitoring laboratories and then to pesticide surveillance
appears to be a reasonable sequence.   Assuming that the certification
of air and water analysis facilities only is considered realistic in
terms of the not too far distant future, the issue at hand is then a
matter of which of these programs should first be implemented.
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Formulated Options

   Option A

      Air laboratories certified before water laboratories.

   Option B

      Water laboratories certified before air laboratories.

Option Assessment

   Option A


      Pro
          There are far fewer air than water laboratories and
          also many fewer air than water pollutants for which
          analyses are routinely made.  For these reasons, it
          would be considerably easier for EPA to initiate a
          certification program addressed to air laboratories.

      Con
          If ease of implementation were the only consideration
          involved, Option A would be favored on this basis.
          However, other factors, such as existing relative data
          quality and variety of data sources are of equal
          importance and do not support this conclusion.

   Option B

     Pro
          Many of EPA's most urgent programmatic responsibilities
          (which include the NPDES regulatory program with its re-
          quirement for extensive, and often complex compliance
          monitoring as well as the Agency's recently assumed re-
          sponsibility for the quality of the Nation's water sup-
          ply) require reliable water quality data.  Further, not
          only are water quality data generated by a far larger
          number of laboratories than is the case for air, as
          stated above, but these laboratories also represent a
          very broad spectrum of capability which potentially re-
          flects a wide range  of  data reliability.  In addition to
          this, some QA staff members believe that the necessary
          technical support for water laboratory evaluation (In
          terms of definition of standards methods, availability
          of reference samples and the past history of effective
          cooperation) is more advanced than is true in the case
          of other media.
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             Con
               Admittedly,  both  the dollar cost and level of effort
               required  for the  implementation of this option would
               be considerably higher  than for the execution of Option
               A because of the  greater numbers of both laboratories
               and pollutants involved.  However, in the case of this
               issue,  the criteria of  cost and effort are regarded as
               less compelling than urgency of need.

     Conclusion

        Option B  is preferred.

Issue VI  Scheduling of State Agency Certification

After analysis of the options considered under Issue IV (Certification
Program Depth), it was concluded that EPA should directly certify State
agencies (beginning with water analysis laboratories  for reasons  pre-
sented under Issue V) only,  with the  States  then  assuming  responsibility
for the approval  of intrastate  laboratories.   The question that arises
here is whether EPA should attempt to implement a certification program
which would address all State laboratories  simultaneously,  or whether  it
should schedule the program on  a progressive basis,  beginning with   •
selected States and subsequently extending  the certification process
until all  States  are included.   Key factors  involved  in this issue  are
dollar costs, ease of implementation  and program effectiveness as well
as the consideration that EPA is relatively  inexperienced  in the  opera-
tion of laboratory certification programs.

     Formulated Options

        Option A

           EPA implements a plan on the basis of certification of
           selected State water agencies,  preferably those which  already
           operate laboratory approval  programs,  in addition to one or
           two other States in  which such programs do not currently
           exist.   (Ultimately,  certification is to be extended to  all
           States, but in a progressive manner.)

        Option B

           EPA implements certification programs on the basis of
           simultaneous certification of all  State water agencies.
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Option Assessment

   Option A

      Pro
          The findings of this study indicate that EPA,  in the
          implementation of certification with respect to State
          agencies already conducting laboratory approval  pro-
          grams, will  encounter a cooperative and helpful  attitude,
          rather than  one of resistance.   For this reason, EPA
          should gain  both first hand information and  guidance
          from experienced State agencies.  This should  prove
          contributary to the resolution  of minor difficulties
          which may arise in the early stages of the program.

          Because mechanisms for laboratory evaluation already
          exist within those States which now conduct  certification
          programs, the level of additional support required from
          EPA should be very much lower than in the cases of
          States which do not now certify laboratories.   Because
          of the considerations presented above, certification of
          States with  currently active programs should reduce the
          time period required to assess  and demonstrate the
          benefits of the program.  Addressing the program in
          its initial  stages to those States which already
          certify laboratories would provide, in essence, an
          excellent preliminary "learning process" opportunity
          for EPA.  However, it is considered that, for  an
          adequate test and demonstration of program benefits,
          the program should also be operated in at least one
          State in which the certification mechanism is  not yet
          established.

      Con
          Extension of State certification in steps will  delay
          realization of program benefits on a national  basis.
   Option B

      Pro
          Simultaneous certification of all  State water agencies
          would accelerate the achievement of improved data
          quality and reliability from all qualifying  laboratories.

      Con
          As indicated earlier, it must be appreciated that,
          although the cost of certification of State  agencies
          by EPA may be relatively low, the cost of approval
          mechanisms for intra-state laboratories by the States
          will  frequently be quite high.   This is because many
          States do not have the equivalent of a QA apparatus for
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                conducting the laboratory evaluation process.   In these
                cases,  therefore, such an apparatus must be established
                and maintained and in many instances this will  prove
                impossible to achieve without substantial EPA grant
                support.  (One estimate of the magnitude of the support
                that might be required, as provided by an official of
                Region  VII, was $200,000 to $300,000 annually per
                State,  including facilities and personnel.)  It is
                virtually a foregone conclusion that EPA cannot, at
                present, commit the necessary support on a national
                basis and this view is, in fact, one of the premises
                on which the option analysis is based.  (It seems
                probable that EPA's prospects for acquiring the
                resources necessary for providing adequate grant
                supplementation ot the States on a national scale would
                depend  to a large extent on some preliminary demonstra-
                tion of the program's effectiveness.  This consideration
                underlies the structure of Option A as formulated.)

     Conclusion

        Option A is preferred.
        The issues identified above and discussed in terms of optional
        approaches to  their resolution are basic in that they address
        general policy positions which must be unequivocally adopted
        before a detailed certification program can be designed.
        Independently of these broad considerations, there is also a
        number of important procedural  program elements which, while not
        presenting major issues, nevertheless require specific formula-
        tion in order to permit the construction of a certification plan
        which is sufficiently explicit for effective review by EPA.
        These elements are identified and discussed in the following
        Section of this report which deals with Phase IV of this  study,
        namely, the development of a proposed certification plan.
Phase IV;  Development of the Preferred Option

Methodology

The term "Preferred Option" as used above is intended to have a more
inclusive meaning than the one employed in the preceding discussion in
which it denoted a preferred alternative approach to the resolution
of a specific defined issue.  Here, "Preferred Option" relates to a
more or less comprehensive certification program which was formulated
for EPA's consideration.   It is a "preferred option" in the sense that
it is based on the recommended alternatives identified above.

In the design of the proposed certification plan, these alternatives
supplied the broad, overall  structure and defined generic policy
positions.   However, for  more complete program formulation, a  number


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of other plan factors and elements also required consideration.   In
some instances, these are independent of specific plan structure.   In
others, they relate to decisions which would affect the manner in  which
recommended issue approaches would be implemented.   In addition, various
potential problem areas were identified and the manner in which a
certification program could be applied in order to  maximize its
benefits to EPA was defined.

General Considerations

The following discussion addresses several diverse  topical areas of the
types referenced above.

     .   Program Authority

        A major and pervasive consideration, which  is independent  of
        specific program structure, is that of the  authority under
        which such a program would operate.  It was pointed out earlier
        in this report that the authorizing legislation or statutes
        which current certification programs cite as their formal
        authorization vary considerably with respect to explicitness.

        In the case of EPA, there does not appear to be any explicitly
        legislative authority for the certification  of environmental
       monitoring laboratories by the Agency itself or for its requiring
        that States certify or license such laboratories within their
        boundaries.  By "explicit authority" in this context is meant a
       defined mandate similar to that provided to  HEW under the  Clini-
       cal Laboratories Improvement Act of 1967 which specifically re-
       quires the licensing of clinical laboratories engaged in inter-
        state commerce.  However, it is quite possible to develop an ar-
       gument for the existence of implied authority through the use of
        such reasoning as the following:

          a) Under current legislation (for example, Sec. 20 of the
             Federal Environmental Pesticide Control Act of 1972)  EPA
             has a clearcut responsibility for environmental  monitoring
             (directly and via the States).

          b) Monitoring data, however, are of limited value unless their
             reliability conforms to some minimal standard of accepta-
             bility (as determined by monitoring objectives).

          c) Even with the support of QA program, there is no final  as-
             surance that minimum data quality standards will  be attained
             unless some regulatory mechanism is implemented,  i.e.,  cer-
             tification or licensing of environmental  monitoring labora-
             tories.
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        d) Therefore, the authority for environmental  laboratory certi-
           fication is logically implicit in EPA's legislated monitor-
           ing responsibilities and additional  authority is not re-
           quired.

     Furthermore, it can be argued that certification  authority is al-
     ready inherent in the regulatory powers of the Administrator, as
     broadly stated in existing legislative instruments.*  However, it
     must be noted that these powers may be invoked only to the extent
     that they are "necessary" for the implementation  of the Adminis-
     trator's "functions" under the Act in question and that there is
     always the possibility that their exercise in a specific case
     might not withstand testing in the courts.

     In general, there are at least three procedural options open to
     consideration by the Agency which relate to the issue of certif-
     ication program authority, although not all of these would satis-
     fy the key objective of such a program, namely that of establish-
     ing an enforceable position with respect to data  acceptance or
     rejection.

     Formulated Options

        Option A

           EPA attempts to obtain passage of specific  legislation au-
           thorizing the establishment and operation of an environ-
           mental laboratory certification program.  This legislation
           would, preferably:

                  incorporate certification authority  for all pertin-
                  ent programs (i.e., air, water, pesticides, etc.)
                  within a single statutory instrument

                  authorize EPA to reject environmental data from un-
                  certified sources

                  forbid the introduction of data from uncertified
                  sources as evidence in legal  actions involving the
                  Agency
For example, Sec. 501(a) of the Federal  Water Pollution Control  Act
Amendments of 1972 states that "The Administrator is authorized  to
prescribe such regulations as are necessary to carry out his functions
under this Act."  Similar language appears in Sec.  301(a) of the Clean
Air Act, as amended 1970, and in Sec.  25(a) of the Federal  Environ-
mental Pesticide Control Act of 1972.
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             authorize EPA to certify or accredit State environ-
             mental agencies with respect to:

                 a)  State laboratory facility and performance

                 b)  State agency licensing of intrastate labora-
                     tories (including municipal, county and pri-
                     vate laboratories)

             provide sufficient time for accomplishment of certif-
             ication on a national basis (assuming that it may be
             implemented progressively)

             appropriate sufficent scheduled funds for EPA pro-
             gram support within the Agency and for the disburse-
             ment of grants to States as required both for the
             supplementation of existing programs and for the
             establishment and operation of new programs where
             there are none at present.

             enable EPA to license intra-state laboratories in
             event of default by or inability of State agencies

             not require EPA to impose changes in existing State
             programs or to prescribe details of proposed State
             programs, provided that the standards and criteria
             for laboratory licensing under these programs are
             no less stringent than those to be employed as the
             basis for State laboratory certification.
   Option B
      On the basis of implied authority under existing legisla-
      tion, EPA promulgates a laboratory certification regulation
      without seeking additional statutory support.   (Note that
      there is no inherent reason for the content of a regulation
      formulated under this option to be different in principle
      from one which would be drafted in response to legislation
      obtained under Option A.)
   Option C
      EPA enters into agreements with cooperating States for the
      implementation of a voluntary certification program.
Option Assessment

   Option A
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   Pro
      The passage of specific authorizing legislation would
      provide the most secure legal basis for a laboratory cer-
      tification program and underlying regulatory issuances.
      Further, such legislation is very likely to include fund-
      ing appropriations.

   Con
      The passage of explicit authorizing legislation could
      require a considerable period of time for its achieve-
      ment.  Meanwhile, if EPA were to rely exclusively on this
      approach, the Agency would be left without means of en-
      suring its minimum data quality requirements are uniform-
      ly met.

Option B

   Pro
      Implementation of this option would permit EPA to insti-
      tute certfication program with minimum delay

   Con
      Election of this option would expose the Agency to the
      possible future risk of an adverse court decision should
      the legal basis of its certification authority be con-
      tested.  It is quite possible that such a decision, if
      sustained, could seriously set back EPA's certification
      program for a considerable period.  (It can be argued,
      conversely, that such an adverse decision could also pro-
      vide the basis for seeking authorizing legislation.) The
      magnitude of this risk is virtually impossible to predict
      and opinions on this point expressed by members of EPA's
      legal staffs varied over a considerable range.

Option C

   Pro
      Assuming the willingness of State agencies to cooperate,
      this option would also permit the early establishment of
      a certification program.  (On the basis of various State
      agency officials interviewed during this study, it is be-
      lieved that the requisite cooperation  would be  forthcom-
      ing in many cases.)

   Con
      A voluntary certification program would obviously lack
      regulatory force and, to this extent,  would not meet key
      objectives.   (However,  such a program  could provide a
      useful preliminary training experience.)
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Comments

Of the three options presented, Option B appears to be the
most attractive because it would both facilitate the early
establishment of a certification program and endow this pro-
gram with legal force.  On the other hand, it carries with it
an identifiable element of risk.  In any case, Option B would
lend itself to progressive certification of State agencies as
recommended (see Issue VI, Scheduling of State Agency Certifi-
cation) as well as to simultaneously certification, should EPA
so elect.  Furthermore, there may also be advantages to pro-
ceeding with Option C (voluntary agreements between EPA and
State agencies) as an interim measure in order to provide time
for program development and refinement prior to its formal
establishment, even though Option B may be adopted in the long
run.  Because of the magnitude and significance of the possible
long-term implications of this issue for the future of EPA's
contemplated certification program, it is considered that op-
tion selection would be most appropriately made by the Agency's
legal staff.

Relation of Certification by EPA to Existing State Programs

It was previously recommended that EPA, in initiating certifi-
cation of State agencies,  include   some States currently con-
ducting water laboratory approval of licensing programs.  There
will inevitably be differences between EPA's program for the
evaluation of State agency capability and performance and the
programs currently operated by States for the assessment of
intra-state laboratories.  Such differences may apply both to
standards and criteria for capability and performance evalua-
tion and to procedural details (such as the frequency of post-
certification proficiency testing).  The position taken in this
study is that the certification program as a whole will be most
effective if the minimum standards and criteria adopted as well
as the qualifying procedures set by EPA are uniformly applied
nationally to laboratories at all levels (State, municipal,
private).  On the other hand, it is obvious that the program
will operate more smoothly to the degree that the States are
least required to alter their own existing programs to conform
to provisions set by EPA.  Therefore, it is recommended that
the "no less stringent than" principle be applied in evaluating
on-going State programs in terms of EPA's eyaluatory standards
and procedures, once these have been established.  For example,
the number of standard deviations within which proficiency
testing results must fall with respect to the target figure
could be based on EPA's promulgated requirements with the pro-
viso that corresponding State program standards would be ac-
ceptable if they were no less stringent than the Agency's.
(This proviso is similar to that relating State water quality
standards to those set by EPA.)  On the other hand, if EPA's
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 requirements with respect to facility evaluation or to profic-
 iency  testing prove to be more demanding than the equivlent
 procedures designated by a State agency and would thus require
 the  expenditure of additional resources to "upgrade" them, sup-
 plemental funding by the Agency may prove the only practicable
 solution.  (In this connection it is noted that the findings
 of this study show many State certification programs to be un-
 derfunded and unable to meet their formal demands as they now
 exist.)  It is believed that, on the whole, the assessment of
 existing State programs which are to be made part of the total
 certification operation should be based on essentially pragma-
 tic  considerations.  That is, any modification of these pro-
 grams  which may be required by EPA should be restricted to
 those  necessary to achieve compliance with the minimal data
 quality standards.

Program Benefit

As stated earlier, the objective of certification is unlike
that of the QA inter-laboratory program in that it addresses
the establishment of acceptable "threshold" standards of data
quality as  opposed to  the overall  upgrading of laboratory per-
formance without defined limits.   Therefore,  the purpose of
certification is not to assure EPA that environmental  data
developed under the program will  be of the highest quality
technologically possible within reasonable economic constraints,
but rather  to assure the Agency that environmental  data quality
will  be at  least minimally adequate for the satisfaction of the
most strTngent monitoring objectives.   It is evident, accord-
ingly, that if a certification program is to successfully serve
this function, it must be geared to a set of standards and
criteria which reflect EPA's needs and not to one which seeks
to be responsive to particular levels of laboratory capability
which are believed to be prevalent in various analytic cate-
gories in order to assure that most evaluated laboratories
will qualify under the program.   Accepting_the_ viewpoint,
therefore,  that certification is intended primarily for the
benefit of EPA directly (unlike the QA inter-laboratory pro-
gram which may benefit State laboratories directly and hence
EPA  indirectly), the question now at hand is, how is EPA to
realize this benefit most expeditiously?  The answer is that, as
a means for assuring the development of environmental data of
not  less than minimally acceptable quality, certification is
no more than a mechanism by which data from nonqualifying
sources may legally be rejected by the Agency.  (In addition,
there are some subsidiary benefits to be expected from the pro-
gram, such as imposition of uniform specifications of probable
measurement error and the like.)  From the viewpoint of this
study, the only really compelling reason for undertaking a labo-
ratory certification program is that this would provide EPA with
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the enforceable authority to prevent the use of environmental
data developed by non-certified laboratories for any purpose or
operation falling within the regulatory and mandated domains of
the Agency.   In relation to this it is noted that EPA's Proposed
Rules in regard to "Water Quality and Pollutant Source Monitor-
ing", which were published in the Federal Register, August 28,
1974, state (under Paragraph P) that "Laboratories (or combina-
tions of laboratories) supporting the State monitoring program
shall provide physical, professional and analytical capabilities
and quality assurance as follows:..."  Many of the details which
follow identify quality assurance practices and procedures which,
presumably, would be required of any laboratory prior to certi-
fication.  However, this Proposed Rule, which appears to concern
intrastate laboratories performing effluent and ambient water
analyses, does not address the consideration of the minimum data
quality acceptable and provides no effective mechanism for
regulatory control by the Agency of laboratories failing to
comply with the stated QA requirements.

Scope of Laboratory Approval

Certification of a laboratory as a total entity will, in many
cases, be totally unrealistic inasmuch as it may prove, after
evaluation, unevenly qualified in various analytic areas.  This
suggests the advisability of "fractional" certification rather
than across-the-board certification.  It is recommended,
accordingly, that the certificate of approval, or equivalent
document, state specific categories of analytical procedure for
which the laboratory is qualified.  (Although proficiency
testing, if thoroughly conducted, may involve a large number of
specific analytic procedures, these usually can be grouped by
class so that the variety of certifiable categories can be kept
within reasonable limits.   For example, CDC recognizes six such
categories.)  It is pointed out that independently certifying a
water laboratory for trace metal procedures under one set of
criteria and for toxic organic compounds under an other is,  in
principle,  basically no different from certifying two neighbor-
ing but separate laboratories, each of which is engaged in only
one of these analytic categories.

Formal  Program Designation

The question of what the program is to be called is not con-
sidered trivial.   Arguments against the use of the term
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 "certification" were presented earlier and, of the various
 possible alternatives, such as "approval," "accreditation,"
 "qualification," and "licensure," "licensure" is preferred.
 particularly with respect to private laboratories because
 it most strongly suggests a process endowed with regulatory
 force.  (Note:  The term "licensure" is used by CDC under
 the authority of the Clinical Laboratories Improvement Act
 of 1967.)   It is suggested that State and lower governmental
 laboratories be "qualified1 and that private laboratories be
 "licensed."  (The latter may not be readily feasible in cases
 in which existing State programs have historically used some
 other term, as in California where water laboratories are
 "approved".)

 Possible State Resistance to Participation

 It is expected that some States will welcome the program,
 particularly those already conducting laboratory approval
 operations, because it will open the possibility of sup-
 plementary  funding support for the improvement of their
 own programs.  With respect to water laboratory licensure,
 however, a  possible problem is foreseen with respect to
 those States which apparently do not plan to participate
 in the NPDES program.  Conceivably, they may resist li-
 censing intrastate water laboratories on the basis of the
 following logic:


    .  Effluent compliance monitoring is the major activity
       of environmental water laboratories.

    .  If the State does not participate in  the NPDES program,
       then EPA is required to assume permitting responsibil-
       ity within that State.

    .  Therefore, licensing water laboratories within the
       State should be EPA's responsibility  (or,  as a mini-
       mum position, what incentive does the State have to
       conduct a licensing program?)

 It would appear that in order to assure ultimate  complete na-
tional  coverage under the licensing program  (whose value would
otherwise be severely impaired)  participation cannot be volun-
tary, but must be required of the States in  the same sense that
participation in areawide waste  management planning (under Sec.
208 of the FWPCAA)  is required.   (Considerations  of this kind
emphasize the need  for explicit  legislative  program authority.)
                        74

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Recommended Program

The essential features of the recommended program which were previously
identified and discussed are the basis of the environmental monitoring
laboratory certification plan proposed for EPA's consideration.  The plan
is presented in the following outline:

[Note:  Some of the recommendations presented belwo do not apply directly
to the formal certification process itself (as proposed for EPA), but
rather to evaluatory and other procedures which, in the context of this
study, are treated as pre-certification or certification maintenance
actions.  However, such actions are addressed where considered appropriate
because of their obvious relationship to the prospective attainment of
certification program goals.]

     Environmental Monitoring Laboratory Certification Program

     Purpose:

        To assure that environmental data accepted and used by EPA is
        in conformity with defined minimum standards of quality and re-
        liability.

     Principal Structural Elements: (applicable to EPA program)

        .  The program should be managed by EPA directly (rather than
           through contracted services.

        .  Responsibility for formal laboratory certification, which is
           considered as an incremental step beyond the laboratory cap-
           ability and performance evaluatory process, should be conducted
           by a new distinct and centralized EPA entity.

        .  Responsibility for evaluating laboratory capability and per-
           formance should be borne by  the QA  interlaboratory  program.

        .  Certification as expanded should be administered on an inte-
           grated basis for all  EPA programmatic areas.

        .  EPA should directly certify or qualify State agencies only,
           with the States assuming responsibility for the certification
           or licensing of  intra-state laboratories.  (Note: The intra-state
           laboratories engaged  in intra-state commerce may required Fed-
           eral licensing also.)*
*  As far as could be determined, EPA's responsibilities with respect to
   laboratories engaged in inter-state commerce are as follows:  If the
                                  75

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   Principal Procedural  Elements:  (applicable to EPA and/or State  Pro-
                                   grams )

      .   EPA must first  determine  whether  a  program is  to  be initiated
         on a mandatory  or voluntary basis (see  preceding  discussion
         of program authority).

      .   The program should  initially address  itself to water analysis
         laboratories, then  air  laboratories  and, later, to radiation
         laboratories and  subsequently, possibly, to pesticide labora-
         tories.

      .   The program should  be initiated with a  small number of States
         which have on-going water laboratory approval  programs and
         should include  at least one State without  a current qualifi-
         cation program.   The Connecticut  and California State
         agencies,  both  of which conduct water laboratory  approval
         programs,  are suggested as appropriate  for initial  considera-
         tion.

      .   It is essential that the  procedures  and operations employed
         for the determination of  laboratory  eligibility by State
         agencies be no  less exacting than those employed  by EPA in
         evaluating State  laboratories  in  order  not to  compromise  the
         entire purpose  of the program.

   Structural and Procedural Program Details:   (applicable to EPA
   and State programs)

      .   Establishment of  Laboratory Evaluatory  Standards  and
         Criteria

         Monitoring data quality requirements should be determined
         by the program  offices  in terms of  the  most exacting
         applications.   This information will  enable the QA staff
         to furmulate criteria and standards  of  laboratory capability
         and performance which the facilities must  meet, as a
         minimum, to satisfy the above  data quality requirements.
         The terms  "criteria and standards" are  used here  in a
         comprehensive sense to  include laboratory  equipment and
         organization and  internal  quality control  operations as
         well as analytic  procedures and personnel  performance.
Agency determines that such laboratories are unfairly restricted under
State statutes in the exercise of their rights,  EPA then has  a  regula-
tory responsibility.  If the Agency determines that no such restrictions
exist, it may, at its option, permit these laboratories to continue
operation under State statutes.
                                76

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         .   Establishment of  Laboratory  Evaluation  Methods  and  Pro-
            ficiency Testing  Procedures  Designed  and  Addressed  to  the
            Above Criteria and Standards.

            It is expected that the establishment of  these  methods and
            procedures by the QA staff will  be accomplished largely
            through appropriate modifications and adaptations of
            existing interlaboratory program elements to meet the
            specific needs of pre-licensing  and licensing maintenance
            evaluatory processes.

         .  Categorization of Licensure

            The  QA staff should  classify analytical  laboratory  procedures
            on a categorical  basis  to permit  the qualification  of labora-
            tories only  for  the  specific areas in  which  they have demon-
            strated satisfactory levels of  capability and  performance.

             Information  Feedback

            The  certification and licensure programs should  provide mech-
            anisms through which facility evaluation and proficiency
             testing restuls  can  be expeditiously provided  both  to candi-
             date and participating laboratories.   (The  experience of
             other programs shows that such  information  is  quite helpful
             to laboratories  in the correction of observed  deficiencies.)

Certification  Program Establishment and  Operation

The following outlines a  program plan specifically designed for the cer-
tification of State agencies  by EPA which addresses:

     a)  Initial  setting  of standards and criteria for  laboratory
         capability and performance evaluation

     b)  Operation of the program

The EPA elements to be involved in the implementation of this plan are
identified below.  Their specific responsibilities will  obviously be  dif-
ferent during the developmental stages of the program from  those to be
discharged during subsequent program operation.  The plan design as set
forth is essentially independent of whether certification is to be estab-
lished on a regulatory basis or is to be initially implemented on a vol-
untary basis with cooperating State agencies.  The resource and staffing
levels required  for  its  operation at various points in time will obvious-
ly depend on whether certification of State agencies is to  be implemented
progressively or simultaneously.
                                    77

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 Involved EPA Elements  (only major responsibilities are listed -
                       others appear on flow charts)

 a) Program  (air, water, etc.) staff and other Agency personnel
   concerned with monitoring data analysis and applications.

   Responsibilities:

       .  Standard Setting

         These personnel will determine data quality and reliability
         requirements in terms of the most stringent normal data ap-
         plication and use (this does not include more exacting re-
         quirements which may be appropriate for research purposes).

       .  Program Operation

         No responsibilities

 b) Quality Assurance Division, Headquarters

   Responsibilities

       .  Standard Setting

         Reviews data quality requirements proposed by program and
         other staff.  Determines their feasibility.

       .  Program Operation

         No major responsibilities

c) Quality Assurance Staff,  NERCS

   Responsibilities

      .  Standard Setting

         Establishes standards and criteria for laboratory capability
         and performance evaluation which  will  reflect the data  qual-
         ity requirements the laboratories are  to satisfy.

         Determines pollutant categories within which  laboratories
         are to be certified.

      .  Program Operation

         Prepares inventory of proficiency testing  reference samples
         and provides these to laboratory  being evaluated  and to  lab-
         oratory being qualified  for certification  maintenance.
                             78

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         Evaluates proficiency testing results and scores laboratory
         performance.
d) Regional Office QA Coordinator/Surveillance and Analysis (S&A)
   Personnel
   Responsibilities
      .  Standard Setting
         No responsibilities
      .  Program Operation
         Performs on-site inspection and facility evaluation.
         Maintains liaison with laboratory and with Certifying Offi-
         cer.
e) Certifying Officer
   The Certifying Officer and his staff constitute a new EPA element
   which is to be independent of the QA organization and to be based
   at headquarters.  The staff is to include field personnel who will
   provide support services to the RO's, but will be organizationally
   independent of them.  It is estimated that a total staff of six
   (Certifying Officer, secretary, and four field personnel) should
   suffice for all fifty States because the functions of this group
   are to be administrative only.
   Responsibilities
       .  Standard Setting
         No responsibilities
       .  Program Operation
         Reviews applications submitted by State agencies.
         Checks results of facility evaluation and proficiency test-
         ing against defined standards and criteria.
         Makes formal certification decision.
         Implements certification actions.
         Participates in RO site  to laboratories which have failed
         to qualify.
                              79

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 The principal  actions  involved  in  the  development of  evaluation  criteria
 and standards  are  presented  in  flow-chart  form  in Figure  1.  A second
 flow-chart (Figure 2)  delineates the overall certification process.  The
 charts  identify the involved EPA elements  and their functions.

 As  discussed in this report, the pre-certification and certification evalu-
 atory processes focus  on  potential  laboratory capability  (as assessed
 through on-site inspection)  and on  performance  (as assessed through pro-
 ficiency testing).   It is  to be noted  that the  assessment of personnel
 qualifications has  not been  included as a  factor in determining  labora-
 tory eligibility for certification, although such assessment is  found  in
 other programs. There  are several  reasons  for this omission. First, surveys
 performed during this  study  indicate that  educational levels and degrees
 are not always reliable indicators  of  laboratory personnel capability  and
 conscientiousness.  (This  refers to  laboratory technicians performing rou-
 tine analyses  as opposed  to  those  engaged  in research investigations.)
 Second, it is  considered  that considerable discretion should be  left to
 laboratory directors in matters relating to personnel evaluation. Third,
 the capability of  laboratory personnel would be assessed  during  the pro-
 ficiency testing process  in  any case.
 The program operating  plan as depicted in  Figure 2 provides for  initial
 certification,  but  not for the  maintenance of certification.  The latter
 process would  involve  the same  kinds of evaluatory procedures as were
 employed for the initial establishment of  laboratory certification eligi-
 bility.   A recommended  design for a certification maintenance program
 includes:

     a)  Annual   on-site  visits and facility evaluations

     b)  Quarterly proficiency testing in all pollutant categories for
         which  laboratory has been previously qualified.

 If  the  results  of (a) and (b) are found satisfactory, no further action
 is  necessary other  than formal  renewal  or extension of the existing cer-
 tification.  If  the results of  (a)  and/or  (b) are found  unsatisfactory,
 the Regional Office issues a deficiency notice to the Laboratory Director
 and, after a suitable period, a revaluation is made of  those facility
 or  performance elements cited as deficient.  If, following revaluation,
 cited deficiencies  persist, a site  visit is then made by the Certifying
Officer's field representative and  appropriate Regional  Office  personnel.
The purpose of this visit is to aid the laboratory in determining the
cause of the problem (i.e., administrative, technical  or personnel  related)
and to provide  guidance and assistance  in its correction.   The  laboratory
 is then allowed 60  days in which to prepare for a second revaluation.
 If the results  are  satisfactory, certification  renewal is  automatic.
Otherwise, a 30 day deli sting notice is issued  by the Certifying  Officer.
During this period, the laboratory  may  appeal  to the Certifying Officer
for review.  Similar procedures  should  be followed  by State  agencies with
respect to intra-state  laboratories.
                                  80

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00
                Program staff personnel
                and other data users,as
                appropriate, propose mini-
                mal acceptable data qual-
                ity levels  based on most
                stringent normal use of
                monitoring data.
                                    Program staff personnel
                                    reviews proposed  data
                                    quality levels with  HQ
                                    QA to determine whether
                                    these are feasible
                            HQ QA transmits data
                            quality requirements
                            judged feasible to
                            appropriate QA/NERC,
                            depending on program.
                            (Data requirements con-
                            sidered impractable
                            are appropriately modi-
                            fied before transmittal
QA/NERC on the basis of data
quality requirements received
and other considerations (such
as approved analytic procedures),
establishes standards and cri-
teria for facility and perform-
ance evaluation for the deter-
mination of certification
eligibility (in relation to the
pertinent tests or test categories
QA/NERC thoroughly
documents the stand-
ards and criteria
developed.
QA/NERC transmits copies
of the documented stand-
ards and criteria to:
                                                                                       a) QA HQ
                                                                                       b) Regional Office
                                                                                          QA/S&A
                                                                                       c) Certifying entity HQ
                         Figure  1.  Flow Chart of Development and Distribution of Certification

                                                 Criteria and Standards

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00
ro
              Laboratory Director applies
              to Certifying Officer (EPA)
              for lab approval. Identifies
              analytic areas for which
              certification is sought.
             Certification Officer trans-
             mits completed forms (a) and
             (b) to
                 a) QA HQ
                 b) Appropriate NERC(s)  '
                 c) Cognizant RO
Certifying Officer sends Lab
Director application package
containing five each (a) and
(b)
    a) Standard application
       forms
    b) Forms for providing
       preliminary informa-
       tion regarding the
       facility and person-
       nel
    c) Set of applicable
       standards and cri-
       teria
Cognizant RO QA coordinator/
S&A personnel contact Lab
Director and arrange on-site
inspection visit
Lab Director
completes and
returns four
sets of forms
(a) and (b) to
Certification
Officer, HQ.
RO personnel in-
spect facility
and prepare re-
port, noting any
significant de-
ficiencies
                                     Figure 2.   Flow Chart of Certification Process

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00
co
             RO directly notifies
             laboratory of evalu-
             ation results and
             cites any deficiencies
             requiring correction
                        T
Lab Director transmits
proficiency test results
to NERC(s).  NERC(s)
evaluates results and
scores laboratory by
Individual test pro-
cedure and/or by
category
                                   Lab Director, after correction
                                   of cited deficiencies, notifies
                                   RO that the facility is ready
                                   to proceed with proficiency
                                   testing (see notes below)
NERC(s) transmits findings
to RO.
                                       On  receipt of notice,
                                       RO  notifies appropriate
                                       NERC(s).   Test samples
                                       are sent  to laboratory
                                       directly  by NERC(s).
                                       NERC(s) notifies QA HQ,
                                       RO  and Certifying Offi-
                                       cer of this action.
RO transmits complete re-
port (including facility
evaluation, any  statement
of deficiency correction,
proficiency test results
and NERC scoring of these
results) to Certifying
Officer
              Notes:   1.   Proficiency testing should not be initiated until significant facility deficiencies
                          have been corrected.
                      2.   Except  in extremely doubtful cases, EPA would accept the laboratory's notice of
                          deficiency correction.
                                                    Figure 2.   continued

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               Certifying  Officer  evaluates
               report in terms  of  applicable
               criteria and  standards.
00
                             If decision is
                             certification is
                             immediate
"yes,"
               Lab  Director may consider that problems
               are  identified and readily correctable
               and  thus request immediate retesting.
                                   Certifying Officer  makes
                                yes/no decision.   In  either  case
                                he sends notices  of decision to:
                                      a    Laboratory
                                      b    QA HQ
                                      c    RO
                                      d  NERC(s)
                                                                                          1
If decision is "no," Certification Officer (or his
field representative), together with RO S&A person-
nel or QA coordinator, visits laboratory to deter-
mine why it failed to qualify and also to suggest
measures of improvement of performance.
                                                                                       _t
                                                             After site visit, the Lab Director may elect
                                                             either of two options
                     Lab Director may ask for postponement of
                     retesting until after internal problems
                     have been corrected.
                                                  Figure 2.  continued

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Program Evaluation:  (applicable to EPA and State  programs)

   .   Need

      The need for a certification program derives from the Agency's
      requirement for environmental data of adequate quality and
      reliability.  Implementation  of a legislatively authorized
      certification system would provide the Agency with a  firm
      legal  base for enforcement. Although  the present QA Program
      encourages data quality improvement,  it cannot in itself en-
      sure the attainment of environmental  data quality objectives

   .   Feasibility

      The feasibility of the certification  program in terms of its
      practical implementation rests largely on these factors:

         a)  Authority

            Either new explicit legislative authority or a  deter-
            mination by the Agency  that its existing statutues pro-
            vide sufficient authority is necessary in order to pro-
            vide the legal  basis for a mandatory program.

         b)  Availability of Resources

            Establishment and operation of  the certification program
            will  obviously require  both funding resources and addi-
            tional personnel  for qualifying the State agencies only.
            Furthermore, intra-state programs will  pose additional
            funding demands to meet the  needs  of State agencies and
            of  EPA, should  it be required to certify  intra-state
            laboratories  because of State default.

         c)  Program Scheduling

            Although  desirable on technical  grounds,  it  may not
            prove feasible to certify all States  simultaneously,
            partly because of EPA's relative inexperience in the
            laboratory qualification process  and  partly  because of
            the level  of costs  which would  be incurred.  For the
            same  reasons, it  is  recommended that  certification in
            all  programmatic  areas  should not be  implemented at once.
            From the vantage point  of this  study,  it is  believed  that
            program establishment and operation will  prove  more feas-
            ible if conducted on.ia  progressive basis.

   .   Probability of  Attaining  Program Objectives

      Over the  long run,  this  is considered  to be high provided
      that the  key problems of authority and  resource support  (for
      both EPA  and State operations) are satisfactorily  resolved.

                             85

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 Probable Impact of Program on  Existing  Laboratories

 Considering water laboratories specifically  (which the  program
 is to cover initially)  it is quite  possible  that many marginal
 commercial  laboratories may fail  to survive.   The severity  of
 this impact would depend, in large  measure,  on the licensing
 standards to be established.   Large and well  qualified  facilities
 should encounter no significant problems.  The capabilities and
 performance levels of many local  governmental  laboratories  as
 well as of some State agencies which are now inadequately funded
 will necessarily improve.

 Ease of Program Implementation

 From a purely technical standpoint, EPA should experience no
 major difficulty in establishing  and operating a program for
 the certification of State laboratories.   The existing  QA Inter-
 laboratory Program and  the NERCs  provide the nucleus of the re-
 quired mechanism for laboratory capability and performance  evalu-
 ation.  Given adequate  funding support  and the additional pro-
 fessional  and technical staffing  which  will  be needed,  there is
 no inherent reason why  these Agency elements  cannot be  developed
 and expanded to the point of adequately supplying all certifica-
 tion technical  support  functions.   Furthermore,  it is expected
 that the two Agency sponsored  studies previously referenced,
 namely, the development of a system for conducting inter-labora-
 tory tests  for water quality and  effluent  measurements, and the
 development and preparation of a  protocol  for laboratory inspec-
 tion, should contribute directly  to the formulation of  detailed
 procedures  for both laboratory evaluation  and  the proficiency
 testing of  water laboratories.

 Problems associated with intra-state program  operations will, in
 most instances, probably reflect  inadequate   funding levels.
 Furthermore,  the salary schedules prevailing  in  some States may
 be insufficiently high  to attract qualified professional person-
 nel.

 Program Costs and Benefits

 The prospective major benefit  of  the program  to  EPA has already
 been identified as  the  provision of a mechanism  for enabling
 the Agency  to legally reject data of uncertain quality.  From
 another point of view,  the program  will  provide  EPA with environ-
 mental  data whose quality and  reliability  will have a high  prob-
 ability of meeting  or exceeding minimum acceptance standards.
 Reliable monitoring data are essential to the Agency  for the proper
discharge of many of its major  responsibilities.

 The cost to  EPA of  operating the formal or administrative por-
 tion of the  program through which the State laboratories are to
                           86

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 be certified  should  be  relatively  low  because  the  pertinent
 functions  can be  accomplished with a small  staff  (estimated
 at six).   On  the  other  hand, the costs of pre-certification
 and certification maintenance evaluation of State  laboratories
 could  be considerable.   The following analysis  is  based on in-
 terviews with personnel  associated with on-going certification
 programs.   The analysis  assumes one annual  inspection  per labora-
 tory and a quarterly proficiency testing schedule.

 Laboratory Inspection and  Evaluation

 Given  ten  EPA Regions and  fifty States, the average annual number
 of inspections to be performed per Region would be five.  The
 time required for each  laboratory  review is estimated  to be six
 man-days.   This is based on the allotment of two days  to travel,
 two days for inspection and evaluation and two days for report
 preparation.   Thus,  the  aggregate  average time required per
 region  (excluding clerical time) would be about thirty days ann-
 ually.  In some instances, Regional Offices may possibly be able
 to accommodate the laboratory inspection function within existing
 staffing resources.   In  any case,  the addition of one  individual
 to the  staff  of each  Regional Office should be sufficient.

 Proficiency Testing

 Assuming quarterly testing of fifty water laboratories per year
 for five pollutant categories (organic, inorganic, trace metals,
 oxygen  demand,microbiological), it  is estimated that the required
 effort  could  be accomplished by a  staff such as the following:

    Function                                     Number

    Proficiency Testing Program Director            1
    Reference  Sample Preparation Technicians        5
    Statistician                                    1
    General   Laboratory Support                      1
    Clerical Support                              	2_

                                   Total           10

Additonal  costs such as travel,  materials,  data processing,  lab-
oratory equipment maintenance and general  overhead are difficult
to estimate in advance of actual  experience, but should not  sub-
stantially exceed 1.5 times the direct costs (assuming  100%  over-
head).   If it is assumed that each  Region  acquires one  additional
staff member to provide the laboratory inspection and  evaluation
function,   the total  staffing increment would be twenty personnel
and  the annual  program budget could be as high as $750,000,if over-
head is taken into account. This figure approximates a "worst case"
 and actual  cost experience may indicate that it is high.  In
 event of State agency default, EPA would then have to assume
                           87

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responsibility for certification of intra-state laboratories for
defaulting States.  It has been estimated that there about 3,000
privately operated water laboratories, most of which are located
in relatively prosperous industrial States, that is, those States
least likely to default.  Assuming the number of laboratories in
defaulted States to aggregate 500, EPA's certification program
would have to be augmented by a factor of 10/1.  This, however,
does not necessarily imply that staffing and related costs would
increase correspondingly.  A factor of 5 or 6 to 1  is probably
more realistic.

The costs of State agency programs will necessarily vary consid-
erably from State to State, depending on such factors as the
number of laboratories per State, and whether certification pro-
grams have already been established.  As indicated  earlier, it
is inevitable that most States will require resource support if
they are to implement certification programs at a level  of ef-
fectiveness acceptable to EPA.  One obvious source  of such sup-
port is the Federal grant mechanism which may, however,  prove
difficult for the Agency to employ without targeted appropriations.
Another possibility is that State agencies may require that lic-
ensing and proficiency testing fees be paid by private laborator-
ies.  In the cases of small facilities, however, fees of signifi-
cant size may impose an intolerable burden and effectively force
these laboratories out of existence.

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                  APPENDIX I
OUTLINES OF CERTIFICATION PROGRAMS REVIEWED
                     89

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                             INTRODUCTION

This Appendix presents synopses of various laboratory certification
programs examined during this study which were considered relevant
to EPA's interests, including those which were the subjects of site
visits performed under the Phase II portion of the project.  The
synopses are grouped by the level  of the certifying organization,
e.g. Federal, State and private.
                                  90

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FEDERALLY OPERATED CERTIFICATION PROGRAMS
                 91

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           HEW, PUBLIC HEALTH SERVICE,  FDA,  BUREAU OF FOODS

I    Background

     A.  Nature of Program

        Approval  by the Bureau of Foods of State laboratories and their
        personnel performing analysis of milk and certification of State
        laboratory evaluation officers  responsible for the approval  of
        laboratories performing such analyses at substate levels.

     B.  Authority

        Grade "A" Pasteurized Milk Ordinance (1965 recommendations of
        the United States Public Health Service).

     C.  Objective

        To establish conformity of laboratory procedures  with those pre-
        scribed in "Standard Methods for the Examination  of Dairy Pro-
        ducts" and "Official Methods of Analysis of the Association of
        Official  Analytical  Chemists".

II   The Certification Process

     A.  Scope

        The Bureau of Foods  directly approves all State Central  Milk
        Testing Laboratories and certifies their analysts for the per-
        formance  of specific tests.   In addition, the Bureau  influences
        state certification  of municipal,  and commercial  milk industry
        laboratories (which  must be  officially designated by  the States)
        in the following  ways:

               The Bureau sets the standards against which laboratory
               procedures and practices are  to be assessed.

               The Bureau prescribes the methods by which laboratories
               are to be  evaluated (in  terms of facilities, personnel,
               etc.)

               The Bureau certifies  State  officials responsible  for  the
               approval of officially designated laboratories  (munici-
               pal,  commercial  and industry  labs).

               The Bureau periodically  performs  check evaluations  of
               milk  laboratories  of  participating states  in order  to
               ensure compliance  with prescribed standards.
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     B. Laboratory Elements Evaluated

        Laboratory facility and operating elements for which standards
        and evaluatory methods have been established may be grouped into
        the following categories:

        Facility

               work areas

               apparatus and equipment

               materials (and their preparation)

        Procedures

               sampli ng*

               general cultural procedures

               test methods (and preparation for tests)

               internal quality control**

               reports and records

        Personnel

        Note:  While laboratory survey forms require only that the sur-
        vey officer ascertain whether "personnel (are) adequately trained
        or supervised", all forms for both laboratory surveys (including
        a "narrative report" which accompanies all  completed survey forms
        in which individual tests are observed) and split sample analy-
        ses require that the name of the analyst performing the specific
        test be noted.  On this basis an analyst is certified for the
        performance of a specific test.
*   At the State level, examination of sampling practices may be dele-
    gated to appropriate State milk evaluation officers.

**  Quality control  procedures are specified  for all  tests for which
    the laboratory is approved.  When the agar plate  method,  for example,
    is used test counts must be duplicable within 5 percent for a single
    analyst and within 10 percent when performed by another analyst.
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     C. Certification Procedures

        FDA Activities
               FDA certifies State Central Laboratories (once every three
               years) by means of announced on-site visits.

               FDA certifies State laboratory certification officers
               principally through an examination of their proficiency
               in performing evaluations when accompanied by FDA ex-
               aminers.

               FDA distributes split samples for testing by State cen-
               tral laboratories at least annually.

               FDA is required to survey for reapproval all State cen-
               tral laboratories at least every three years.

               FDA reevaluates State laboratory certification officers
               at least every five years.
        State Activities

               States evaluate municipal, commercial  and milk industry
               laboratories (and their personnel) by means of announced
               on-site visits.

               State milk laboratory certifying agencies are required
               to split samples at least twice per year with each
               official and/or officially designated  milk laboratory.

               States are required to evaluate for reapproval  all
               official and officially designated milk laboratories
               at least once every two years.

               States are required to send annually to FDA a list of
               approved laboratories (including the date of the last
               evaluation test(s)  for which approved).

Ill  Identified Problem Areas

     The implementation of the "milk program"  is not  currently experi-
     encing any difficulties.   The success of  the program is attested
     to by the recent request of many State laboratories that  FDA imple-
     ment a laboratory standardization program for food testing similar
     to that for milk.

IV   Program Administration and Evaluation

     The administration of the program is the  responsibility of technical
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personnel only.   The branch relies on the quality of the results
received from participating laboratories for their evaluation of
the program as a whole.

Cost and Level of Effort Estimates

Laboratory evaluations performed by the Bureau are financed on a
case by case basis, each requiring approximately 20 manhours of
effort (exclusive of travel time).  Cost estimates for the pro-
gram as a whole have not been made since 1964.
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          USDA - ANIMAL AND PLANT HEALTH INSPECTION SERVICE

I    Background

     A.  Nature of Program

        The Health Inspection Service (APHIS)  certifies  private  and
        industrial laboratories  to perform tests  on meat samples for
        the meat industry.

     B.  Authority

        General Meat Inspection  Act of 1906.

     C.  Objective

        The objective of this certification program is twofold:

               To relieve the government laboratories of the  burden
               of testing all processor meat samples

               To ensure that tests performed  by  private and  industry
               laboratories conform with procedures selected  by  APHIS
               from the "Official  Methods of Analysis of the  Associa-
               tion of Official  Analytical  Chemists"

II   The Certification Process

     A.  Scope

        APHIS directly certifies each of the 166  laboratories which
        participate in the Agency's program.   It  also performs periodic
        check evaluations of USDA meat inspectors who select  and pre-
        pare split samples  for analysis by both USDA itself and  by lab-
        oratories being examined for certification  or recertification;
        APHIS also prescribes the testing standards and  methodologies
        for the performance of specific analyses.

     B.  Laboratory Elements Evaluated (during  laboratory visit)

        Facility

               the general  appearance of the laboratory

        Procedures

               precision in following test methods  prescribed by
               APHIS is evaluated
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         Personnel

         Note:  Other  than the requirement that the laboratory supervisor
         must  hold a degree from an accredited college or university, no
         rigorous evaluation of personnel (independent of their profic-
         iency in testing) is performed.  Personnel qualifications and
         performance are more carefully scrutinized only where testing
         problems arise.

         Records

         An  updated version of the "standards book" as well as complete
         test  records  are required.

      C.  Certification Procedure

         APHIS certifies laboratories for an indefinite period by:

               Examination of laboratory qualifications (e.g., fulfill-
               ment of educational requirements by supervisory personnel

               Split  sample testing (successful performance on 30 tests
               is required prior to certification).  Subsequently a
               minimum of 4 split sample analyses per month (of which
               one is randomly selected for analysis by USDA) is re-
               quired for maintenance of certification.

               On-site laboratory surveys on an as needed basis

        APHIS periodically checks  regional  inspectors principally
        through:

               Verbal  examination  (these  examinations are  conducted  in
               the field)

               Examination of  inspector's records

III  Identified Problem  Areas

     No problems  associated with program  effectiveness as  a whole were
     identified.

IV   Program Administration and Evaluation

     All  on-site  laboratory visits are  performed by a single evaluator
     from the Washington office of the  service.  Sample collection is
     the responsibility of USDA regional  personnel.
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Economic Aspects of the Program

The laboratory certification program resulted in a savings of
approximately $200,000 in Federal funds in 1973 because of the
reduced number of sample analyses required to be performed by
Federal laboratories.  Local laboratory certification also repre-
sents a cost savings to the meat industry which has found that the
use of local laboratories reduces mailing expenses and delays in
waiting for test results.  For these reasons, although Federal
sample analysis is provided without charge to the meat packers,
they prefer, in many cases, to pay private laboratories to perform
these tests.
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              DEPARTMENT OF HEALTH, EDUCATION AND WELFARE
           PUBLIC HEALTH SERVICE, CENTER FOR DISEASE CONTROL
                     LABORATORY LICENSURE SECTION

I    Background

     A. Nature of Program

        Clinical laboratories receiving specimens in interstate
        commerce are licensed to perform tests in six broad categories.
        The types of laboratories licensed under this program are:

               Hospital

               A laboratory located in a hospital, or, if outside the
               hospital, is operated by, or under the supervision of
               the hospital or its organized medical staff, and serves
               the hospital's patients.

               Independent

               A laboratory which is independent of both the attending
               or consulting physician's office and of a hospital.

               Industrial

               A laboratory owned and operated by a company or corpora-
               tion primarily for its own employees' medical  care.

           .    Public Health

               A laboratory belonging to a governmental  unit and pri-
               marily involved in obtaining public health information.

     B. Authority

        The Clinical  Laboratories Improvement Act of 1967.

     C. Objective

        The licensure program is intended to foster the improvement  and
        maintenance of quality of laboratory performance by contributing
        to the conformity  of laboratory procedures with standards pre-
        scribed by the Public Health Service.

II   The Certification Process

     A. Scope

        Any laboratory soliciting or accepting specimens in interstate
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   commerce is required to hold a license or letter of exemption
   issued by the Secretary, Department of Health, Education and
   Welfare.  Approximately 800 laboratories have been approved to
   date.  At the discretion of the Secretary, a laboratory which
   is accredited by an HEW approved accrediting body or which
   agrees to a special inspection and/or records submittal
   arrangement with CDC may qualify for a letter of exemption from
   the Secretary.
B. Laboratory Elements Evaluated
   Facility
          work and storage space
          safety equipment
          condition of equipment
          temperature and humidity
   Procedures
      Test procedures in
          microbiology and serology
          clinical chemistry
          immuno-hematology
          hematology
          pathology
          radiobioassy
      Quality control  procedures (including preventive mainte-
      nance of equipment,  labelling of reagents,  QC records
      maintenance, etc.)  fire  safety and laboratory accident
      control  procedures.
   Personnel
      Evaluation of personnel  qualifications  and  duties is based
      on essentially the  same  criteria as  those used in the  Social
      Security Administration's  Medicare (Health  Insurance for the
      Aged)  program.   Qualifications for the  laboratory director
      are described below  as an  example.   The Director must  be
      either:
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          physician certified  in  anatomical  and/or  clinical  pathol-
          ogy by the American  Board  of Pathology  or the American
          Osteopathic Board of Pathology,  or possess qualifications
          equivalent to those  required, or

          physician certified  by  American  Board of  Pathology or the
          American Osteopathic Board of Pathology in at least one
          laboratory specialty,   or  is certified  by the American
          Board of Microbioloby,  the American Board of Clinical
          Chemistry, or other  national  accrediting  board  acceptable
          to the Secretary in  one of the lab specialties,  or sub-
          sequent to graduation has  had four or more years of
          general laboratory training and  experience of which two
          years were spend acquiring proficiency  in one of the
          laboratory specialties  at  the doctoral  level, or

          holder of an earned  doctoral  degree from  an accredited
          institution with a chemical,  physical,  or biological
          science as his major subject and is certified by the
          American Board of Microbiology,  the American Board of
          Clinical Chemistry or other accrediting board acceptable
          to the Secretary in  one of the laboratory specialties,
          or subsequent to graduation has  had four  or more years
          of general clinical  laboratory training and experience,
          of which at least two years were spent  acquiring profi-
          ciency in one of the laboratory  specialties in  a clinical
          laboratory with a director at the doctoral  level.

   It should be noted that special emphasis is placed on  personnel
   qualifications in the application forms.

   Records and Reports

          records of observations and specimens

          records retention

          adequacy of reports  to  DHEW

          methodology documents

C.  Certification Procedure

   Subsequent to application by a laboratory for  licensure,  CDC
   initiates a laboratory evaluation in which the following  steps
   are included:

          laboratory personnel (principally the director,  general
          supervisor and technical supervisor) are  appraised.
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               an announced on-site visit is  performed.

        The laboratory as a whole is then evaluated  and,  if  all  CDC
        conditions are met, is  licensed  for the  performance  of  specific
        tests.   After licensure,  laboratories participate in a  pro-
        ficiency testing (PT) program (in which  blind  samples are  dis-
        tributed to reference laboratories as well as  to  participating
        laboratories).   Continued licensure is dependent, or course,  on
        satisfactory PT results.

        Maintenance of licensure  requires:

               continued satisfactory PT results

               satisfactory results of annual  on-site  visits

III  Identified Problem Areas

     Minor technical problems have arisen within CDC with reference to
     the internal changeover to a computer operated  data  system.   It  is
     expected,  however, that these problems will  soon  be  resolved.  A
     more serious problem is a  legal  one and  is  associated with
     "adverse actions"  on the part of CDC.  According  to  the Clinical
     Laboratories Improvement Act of 1967, a  laboratory which does not
     conform to the requirements  of the  CDC (e.g., does not  return
     results on proficiency testing samples)  will be subject to
     "adverse action" by the Center,  resulting in a  revocation of  the
     laboratory's license.   According to personnel in  the Laboratory
     Licensure Section, however,  "adverse actions" have not  been
     initiated in a timely manner, with  the consequent continued
     operation of laboratories  which do  not meet CDC performance
     standards.  The cause of this problem has not yet been  isolated
     but the delay is,  at present, a major internal  concern  of  the
     agency.

IV   Program Administration and Evaluation

     The Laboratory Licensure Section of the  CDC, which is responsible
     for the performance of the tasks outlined above,  currently employs
     eleven examiners.   In addition to their  responsibilities with
     respect to CDC licensure,  these examiners check a minimum of  10%
     of State and private agency  certified laboratories in cases where
     State or private accreditation programs  (e.g.,  of the College of
     American Pathologists) have  been rated as equivalent to CDC
     licensure.

     CDC relies principally upon  input from licensed laboratories and
     from PT results to determine the effectiveness  of its licensure
     program.


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V    Cost and Level  of Effort Estimates

     Independent of travel  expenditures  associated with the on-site
     visit, the estimated cost of licensing a laboratory is approxi-
     mately $125.00.  Laboratories pay a fee of $25.00 for each section
     exami ned.
VI   Comments

     Relationships With Other Agencies
        CDC has approved the inspection and accreditation program of
        the College of American Pathologists as equivalent to CDC
        licensure as well as some State programs.  Only New York
        is equivalent in all testing areas, although programs of the
        States of Utah and Wisconsin have been approved in part.  CDL
        does some licensing at the State level for the Medicare pro-
        gram of the Social Security Administration.
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  DEPARTMENT OF LABOR,  OCCUPATIONAL  SAFETY AND HEALTH ADMINISTRATION
                     DIVISION  OF  SAFETY  STANDARDS

I    Background

     A.  Nature of Program

        OSHA is considering  accreditation of  independent  laboratories
        which evaluate  the safety of specified products,  devices,
        systems, materials and installations.*

     B.  Authority

               Williams-Steiger Occupational  Safety  and Health  Act of
               1970

               Contract Work Hours and Safety Standards Act

     C.  Objective

        To facilitate the enforcement of occupational  safety and health
        standards.

II   The Certification  Process

     A.  Scope

        Under the proposed program all laboratories  engaged in  product
        safety testing  would be required to  obtain accreditation from
        OSHA in order to continue performance of these tests.  Accred-
        ited laboratories would,  in effect,  act  as extensions on OSHA
        in their role as product  testers and  certifiers.

     B.  Laboratory Elements  Evaluated

        Facility

               the availability and condition of facilities and equip-
               ment relevant to the testing  of  the product for which
               accreditation is requested

               housekeeping practices
     29 CFR 1907, which sets forth "Criteria and Procedures for
     Accrediting Testing Laboratories", may be revoked because of signi
     ficant errors in the text.  Public comments concerning proposed
     changes are now being evaluated by the agency.  Information pre-
     sented here is derived principally from the original text of
     29 CFR 1907.
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        Procedures
           General duties  and  qualifications  are  evaluated  for:
               laboratory  director
               technical director (chief  engineer)
               technical supervisor  (department manager)
               testing monitor
               technical staff
     C.  Certification Procedure
        Initial  Accreditation
               Subsequent  to the  filing of an application by  a  testing
               laboratory, OSHA would  perform an  on-site survey  to
               verify the  information  supplied by the  laboratory.   The
               period of accreditation is two years.
        Maintenance of Accreditation
               In addition to  maintaining those laboratory  and  testing
               conditions  required for initial accreditation, a  labora-
               tory must demonstrate its  ability  to  perform functions
               associated  with the following  general areas:
               .  product  acceptance
               .  recordkeeping
               .  reports
               In addition, the laboratory must:
               .  grant OSHA the  right to conduct unscheduled laboratory
                  inspections
               .  participate, at its  own expense, in  periodic  reference
                  sample test  programs under  the  direction  of OSHA.
Ill  Identified Problem Areas
     None
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IV   Program Administration and Evaluation
     Neither administrative nor evaluatory procedures have been
     finalized to date.
V    Cost and Level  of Effort Estimates
     None currently  available.
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                  HEW SOCIAL SECURITY ADMINISTRATION
                      BUREAU OF HEALTH INSURANCE

I    Background

     A.  Nature of Program

        The Bureau of Health Insurance (HEW)  provides  fiscal  support
        for independent clinical  laboratories performing  services  under
        the Medicare program.   This  support takes  the  form of reim-
        bursement to laboratories complying with the conditions
        specified by the Administration under the  supplementary  medical
        insurance part of the Health Insurance Program for the Aged
        and Disabled.*

     B.  Authority

        The Administration Procedures Act  (5  USC 553).

II   The Certification Process

     A.  Scope

        The Bureau of Health Insurance (BHI)  of the  Social  Security
        Administration certifies  approximately 3,000 laboratories,
        using State certifying personnel.   In addition  the BHI:

               sets the standards against which laboratory procedures
               and practices are  to  be assessed

               prescribes  the  methods to be used by  State  examiners
               during laboratory  inspections

               approves all  officials designated by  the State to per-
               form on-site  evaluations of  laboratories

     B.  Laboratory Elements  Evaluated

        Facility

           .  adequacy of space

               ventilation
    Proposed new implementing regulations, which will slightly alter
    the requirements for eligibility, were made public on July 2, 1974
    and are expected to be finalized with only minor modifications.
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         fire and safety precautions
   Equipment
         adequacy of equipment
         calibration
   Procedures
         quality control procedures*
         test methods
   Personnel
      qualifications and duties are  prescribed  for:
         laboratory director
         laboratory supervisor
         technical personnel
   Records  and Reports
         notebooks describing current  laboratory methods
         specimen records
         laboratory reports
   Note:  BHI  notes that a  laboratory's compliance  with personnel
   qualifications  requirements is the most significant factor
   determining  its  initial  accreditation.   Subsequent maintenance
   of accreditation however,  relies  more heavily on other  labora-
   tory elements,  such  as quality control  procedures and the
   ability  to  demonstrate accurate and  correct  test methods.
C.  Certification Procedure
   Laboratory  Approval
         The  applicant laboratory completes forms  supplied to it
          by the State.
Proposed quality control  requirements are identical  to those
required by the Center for Disease Control  (CDC).
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               State inspection officials  (or  licensure inspectors
               where State laboratory licensure programs exist)  who  are
               approved by BHI, perform an on-site  visit to  the  appli-
               cant laboratory.

               Regional personnel  of the Social  Security Administration
               review the laboratory's application  as well as  the
               recommendation of the State inspector and make  the final
               accreditation decision.

               Maintenance of accreditation requires that the  laboratory
               participate in one of several approved proficiency testing
               programs (e.g., a State licensure testing program, CDC,
               College of American Pathologists).

               The program calls for annual  reexamination of each
               participant laboratory.
        Inspector Approval

               State laboratory inspectors  are  selected  principally  on
               the basis  of their academic  qualifications.

               The performance  of State  laboratory  inspectors  is  usually
               evaluated  every  two years.   This is  accomplished in the
               following  manner:

               .   spot checks are performed on  laboratories  approved by
                  an examiner

               .   HEW regional  personnel accompany  the State examiner on
                  selected  laboratory  inspections

III  Identified Problem Areas

     Because the details  of the proposed regulations are not available,
     it is as yet uncertain to  what degree  the  program modifications
     will  affect the level  of future State  participation.  There  is  con-
     cern  within the administration that a  reduction of  State  responsi-
     bility may be implicit in  these program modifications and, in such
     case, certain BHI personnel  believe that BHI-State  relations may
     deteriorate with as  yet unforseeable results to the program.

IV   Program Administration and Evaluation

     The majority of BHI's  laboratory  approval  functions are performed
     by the Agency's regional offices.  Only in cases of "problem
     laboratories" are decisions  referred to the Central  Office.  In
     addition, the Central  Office makes all  decisions regarding approval
     policy.

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     BHI relies principally on the efforts of the Program Validation
     and Integrity Branch of the Agency, which uses such evaluatory
     techniques as site studies and surveys to evaluate the operation
     of its approval program.  In addition to the activities of this
     branch, inspections of State survey operations every two years
     provide data on which program evaluations are based.

V    Cost and Level of Effort Estimates

     None was available from the Bureau.

VI   Comments

     The structure of the BHI laboratory approval  program contains two
     features which may be of interest to EPA.   These are:

        .   Reliance of the central  office on regional  offices for
           program operation

        .   Extensive use of State laboratory examiners
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            EPA WATER QUALITY  OFFICE,  WATER  SUPPLY  DIVISION

I    Background

     A.  Nature of Program

        Certification, by EPA,  of State  laboratories  analyzing  potable
        water on interstate  carriers and of  State laboratory  certifica-
        tion officers who examine laboratories at substate levels.

     B.  Authority

               Presidential  Reorganization Plan  No. 3 which establishes
               EPA and transfers  to  it responsibility for this  program.

               Interstate Quarantine Regulations of the  Public  Health
               Service

     C.  Objective

        Conformity of laboratory  procedures  for  microbiological  testing
        with those prescribed  in  "Standard Methods  for the Examination
        of Water and  Wastewater"  to ensure data  quality.

II   The Certification Process

     A.  Scope

        EPA's Water Supply Division  (WSD) directly  certifies  all  State
        Central Water Laboratories with  respect  to  potable water
        quality testing.   In addition, EPA influences state certifica-
        tion of local agency and  private laboratories within  each state
        in the following  ways:

        .   .    WSD sets the  standards  against which laboratory  pro-
               cedures and practices are to  be assessed

               WSD prescribes  the methods by which  laboratories  are  to
               be evaluated  (in terms  of facilities,  personnel,  etc.)

               WSD approves  state officials  responsible  for the  certifi-
               cation of  municipal and commercial water  laboratories.
               (All data  gathered by these state laboratory certifica-
               tion officers must be made available to WSD.)

        Typically, WSD certifies  one central laboratory  and approves two
        evaluation officers  in  each state.

     B.  Laboratory Elements  Evaluated
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   Note:  The procedures for sample testing methods for use by
   state laboratories, laboratory evaluation methods and criteria
   as well as the potable water quality standards themselves are
   currently being reviewed and revised.  Guidance documents
   reflecting these revisions are not available.  For this reason
   the information presented below, while current, is subject to
   change.

   Identical elements are examined for initial certification of
   laboratories at both the state and local levels as well as for
   their periodic recertification.  Laboratory facility and oper-
   ating elements for which standards and evaluatory methods have
   been established may be grouped into the following categories:

   Procedures

          sampling

          sterilization

          test methods

          laboratory safety practices

      It is noted that there are few explicit requirements for the
      establishment and maintenance of internal  laboratory quality
      control procedures.

   Facility

          special purpose space (e.g., incubator room, work space)

          apparatus and equipment

C. Certification Procedure

   .   WSD certifies state laboratories and state laboratory
      certification officers

   .   States certify local  and commercial  laboratories

   .   At both Federal  and State levels certification is accom-
      plished through announced on-site visits

   .   WSD procedures call  for triennial  reviews  of state central
      laboratories by on-site visits as  well  as  for biennial
      reviews of State laboratory certification  officers by on-
      site visits
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        .   WSD may directly review local  laboratory performance if
           considered necessary

III  Identified Problem Areas

     Relationships with the State Laboratories

        Corrective approaches  employed:

               WSD has used its certification program  to  provide
               technical  assistance to  laboratories.   The regulatory
               purposes of certification  have been  deemphasized.

               Research undertaken by WSD has resulted in technical
               innovations which, when  used  by  State laboratories,  have
               resulted not only in improved water  quality testing  pro-
               cedures, but also in cost  and time savings for  the
               laboratories.

IV   Cost  and Level  of Effort  Estimates

     An average laboratory evaluation requires  56 manhours (two days
     for on-site evaluations and five days for  report  preparation)  of
     grade levels thirteen through fifteen personnel.   In addition,
     approximately eight manhours are required  for  the typing  of each
     report.   Detailed cost data, beyond  these  manhour estimates are
     currently unavailable.
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STATE OPERATED CERTIFICATION PROGRAMS
                 114

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                    NEW  YORK  DEPARTMENT  OF  HEALTH
                 DIVISION  OF LABORATORIES AND  RESEARCH

I    Background

     A.  Nature of Program

        The State Health Department approves laboratories  to test
        samples from public water supplies  in  cases where  the data
        generated is to  be used to show compliance  with the State
        sanitary code.

     B.  Authority

        New York State Health Rules and Regulations, Title 10 parts
        5 and 72

     C.  Objective

        To ensure that all data generated by approved laboratories
        will meet minimum  standards and to  ensure reliability of
        laboratory results.

II   The Certification Process

     A.  Scope

        The Health Department approves approximately 100 laboratories
        for the performance of chemical and biological  tests on water.

     B.  Laboratory Elements Evaluated

        Facility

               adequacy of space

               availibility and condition of specified equipment

        Procedures

               test procedures*

               safety procedures

               internal quality control
     The Department uses EPA forms [EPA 103 (Cin) (Rev 3-71)] to
     evaluate bacteriological test procedures.
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        Personnel

               Qualifications stress educational background in the case
               of technical managerial personnel.  Technicians are
               rated in terms of their skills and experience.

        Records and reports

               test records are reviewed for completeness of information

     C. Certification Procedure

        .   A laboratory makes application to the State Health Depart-
           ment for initial approval

        .   Laboratory staff personnel of the Health Department perform
           an on-site evaluation of the laboratory in which the elements
           noted above are examined

        .   Acceptable laboratories are approved for submittal  of data
           as evidence of public water supply complience with sanita-
           tion code

        .   Laboratories are scheduled for examination (for renewal of
           approval) every two years

III  Identified Problem Areas

     The principal  problem with which the operation of this program
     contends is financial.  The Department receives no special  alloca-
     tion  for its approval program and must, therefore, use funds
     needed for Department laboratory operations to perform its  approval
     related functions.  The following program deviciencies have been
     identified by the Division as attributable to the lack of adequate
     financial  support:

        .   inability to consistently perform on-site visits for  renewal
           of approval  as scheduled (every two years)

        .   lack of a reference sample program (the Division considers
           such a program to be essential  to effective approval  program)

IV   Program Administration and Evaluation

     The program has no full  time  staff for the operation  of its
     approval  program.   Health Department  laboratory staff members are
     used  to perform on-site evaluations and department supervisory
     personnel  make  all  final  approval  decisions.
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There is no existing satisfactory feedback mechanism through which
the Department can assess the effectiveness of its  program.
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            OKLAHOMA DEPARTMENT OF HEALTH,  SYPHILIS SEROLOGY
                       PROFICIENCY TESTING  PROGRAM

I    Background

     A.  Nature of Program

        The Health Department certifies  the following categories of
        laboratories to perform premarital  and  prenatal  blood sample
        testing:

               a  laboratory in a hospital currently licensed by the
               Oklahoma Department of Health

               a  laboratory owned and/or directed  by a physician
               licensed to practice in Oklahoma

               a  public health laboratory operated by a  County or
               Municipality and staffed  by  personnel  classified under
               the State Merit System or equivalent personnel  adminis-
               trative system

               a  private laboratory certified  in the specialty of
               microbiology, subspecialty serology, under  provisions
               of "Conditions of Coverage of Services",  Social  Security
               Administration, U.S.  Department  of  Health,  Education,
               and Welfare

     B.  Authority

           .    43 O.S. 1971  Sec 31-37

           .    63 O.S. 1971  Sec 1-515

     C.  Objective

        The maintenance of a satisfactory level of performance in the
        serological  testing of blood samples.

II   The Certification Process

     A.  Scope

        The Department has so far certified about  200 laboratories
        which comply with the standards  and procedures prescribed by
        the Health Department.

     B.  Laboratory Elements  Evaluated
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   Facility
          space, ventilation, temperature control, lighting
          equipment*
   Procedures
          compliance with minimal technical standards for test
          procedures authorized by the Commissioner of Health
   Personnel
          Both academic and experimental qualifications are
          specified for all laboratory personnel performing
          serologic tests for syphilis.
   Records and reports
          adequacy of report forms which accompany test samples
          quality control records
          adequacy of reference materials
C. Certification Procedure
   For initial certification a laboratory must:
          demonstrate proficiency in testing methods as well  as the
          adequacy of facility, personnel and records
          analyze four series of ten samples with a grade of 90%
          or better
   For maintenance of certification a laboratory must:
          analyze six series of ten samples each year with a
          grade of 90% or better
   The proficiency testing program uses the services of three
   referee laboratories to evaluate each applicant ("test")
   laboratory.  Samples are split among the referee and test
   laboratories and successful  performance is measured in terms
Equipment prescribed in the "Manual  of Tests for Syphilis"
HEW, PHS Publication No.  411  is required to be available.
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        of the applicant laboratory's ability to:

               produce results which are in agreement (by no less
               than 90%) with those of the reference laboratory

               reproduce, when required, results of past analyses

        In the event of inadequate proficiency test performance, a
        laboratory is placed on "probation" (during which it is
        debarred from performing tests for the public)  for six months.
        During this period laboratory personnel  receive training from
        State officials in correct laboratory procedures.

Ill  Identified Problem Areas Currently Identifiable

     No problems.

IV   Program Administration and Evaluation

     The Health Department relies principally upon the  results of its
     participation in a CDC sample testing program for  the evaluation
     of its technical capability to assess test  results from labora-
     tories which  it accredits.  However,  as is  true of most certifi-
     cation programs, no formal internal quality assurance mechanisms
     exist with respect to the administrative and/or on-site evaluation
     aspects of its program.

V    Cost and Level of Effort Estimates

     The program supervisor estimates that one to two manhours are
     required to evaluate laboratory performance in a specific test
     area.  No dollar cost estimates were  available.
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                  OKLAHOMA STATE CERTIFICATION PROGRAM
                     OKLAHOMA WATER RESOURCES  BOARD

I    Background

     A. Nature of Program

        Water laboratories receiving water analysis specimens  within
        the state of Oklahoma are licensed to  perform  tests  in three
        broad categories.

               "A" laboratories  are mineral  and  metal  water  analysis
               laboratories having a limited scope  of  activities.

               "AA" laboratories are mineral and metal water analysis
               laboratories able to perform under all  or  nearly all of
               the test range surveyed  by  the  OWRB.

               "AAA" laboratories are laboratories  which  qualify under
               the "AA" classification  and also  have a biological
               capability.

     B. Authority

        The program is  operated  under the  rather broad authority of long
        standing legislation.*

     C. Objective

        The licensure program is intended  to improve reliability of
        laboratory analytical  results and  to promote the  maintenance
        of high quality standards.

II   The Certification  Process

     A. Scope

        Any laboratory  doing water analysis  work within the  state of
        Oklahoma is eligible to  be licensed  by the  OWRB.  The  list of
        licensed laboratories published  by the Board is a powerful
        driving force which compels most Oklahoma Water Analysis
        laboratories to enter the program.   There are  thirty-seven
        laboratories active in the program at  present.

     B. Laboratory Elements Involved
     Identification  of  the  specific  legislation was not provided.


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        Facility
               equipment
               physical  plant
        Personnel
               number and types
               qualifications
        Procedures
               metal  analysis
               mineral  analysis
               biological analysis
               quality control
        Proficiency testing
               number of categories
               accuracy
III  Identified Problem Areas
     Insufficient  funds  (the present funding  level  is  approximately $5,000)
     permit only annual  proficiency testing.   Reference  samples,  as obtain-
     ed from the United  States  Geological  Survey,  sometimes  do not reflect
     "real  life" conditions.  Annual  on-site  evaluations of  all  laboratories
     are not possible within present resource allocations.
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             CONNECTICUT,  STATE  DEPARTMENT OF  PUBLIC  HEALTH
I    Background
     A.  Nature of Program
        The Health Department approves  and registers  private  and
        municipal laboratories as  public  health  laboratories  for  the
        examination of water and sewage and trade wastes.*
     B.  Authority
        The Connecticut Public Health Code Section  19-13-A35
     C.  Objective
        To safeguard the public  health, safety and  welfare
II   The Certification Process
     A.  Scope
        The Health Department approves  and registers  approximately
        sixty private and  municipal  water laboratories within the
        State.  Private laboratories are  approved  to  test discharge
        samples for industries on  a  fee basis.   Municipal laboratories
        are registered to  perform  tests on municipal  water  supplies
        and sewage.
     B.  Laboratory Elements Evaluated
        Facility
               special purpose space
               apparatus and equipment
        Procedures
               sampling
               sterilization
               laboratory  safety practices
     Laboratories may also be approved for the performance of tests
     on dairy products and some foods under this program.
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          test methods*

          Note:  The laboratory must be able to demonstrate its
          ability to perform bacteriological, physical and
          chemical tests using either methods identical to those
          found in the American Public Health Association's
          Standard Methods for the Examination of Mater and Waste-
          water or other methods which are acceptable to the
          Department.
    Personnel

          Qualifications of the laboratory director and key
          personnel are evaluated prior to consideration of a
          laboratory for registration by the Health Department.
          The requirements for the laboratory director are
          described in "C" below.

C.  Certification Procedure

    Before a laboratory may be registered by the Department of
    Health, the laboratory director must receive State approval.
    In order to qualify he must:

          hold at least a B.A. in a field related to the work
          area for which his laboratory is requesting certification

          have at least one year's experience in water and sewage
          analysis

          pass a qualifying examination given by the Health
          Department

    When the availability of a director meeting the specifications
    outlined above is established, the laboratory may make formal
    application for approval.   The following steps are typical  of
    the laboratory approval  process:

          An announced on-site inspection of the laboratory
          facility is performed.

          A technical  review of the site visit results and informa-
          tion contained in the application of the laboratory  is
Forms describing the required test methods for bacteriological
analyses are identical  to those used by EPA's Water Supply
Division.

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               made.   Any significant deficiencies are noted and the
               laboratory is advised to correct these deficiencies.

               When the facilities and personnel  of the laboratory meet
               the specifications of the Laboratory Division, the
               laboratory is approved and registered.

        Each laboratory is re-registered and approved annually.
        The following are the principal criteria used in annual
        evaluations.

               The adherence of the laboratory to all regulations and
               statutes of the State.

               The laboratory's performance in the State proficiency
               evaluation program.  (Water samples for this  program
               are currently supplied on a yearly basis by NERC-
               Cincinnati.  By 1975, however,  the State Health Depart-
               ment expects to prepare its own samples and to distri-
               bute them biannually.)

               The laboratory's performance during an on-site inspec-
               tion.

Ill  Identified Problem Areas

     As is the case with similar State programs,  the operation of the
     Connecticut registration and approval program is hampered by a
     lack of funds and work space and by an inadequate number of
     trained examiners.  Currently, one examiner is responsible not
     only for the registration and approval of private and municipal
     water laboratories but also for the evaluation of laboratories
     testing milk, foods and food utensils.

IV   Program Administration and Evaluation

     The laboratory approval programs are the responsibility of a
     single person within the Health Department.   He relies  principally
     on the results of proficiency tests to determine the effects of
     the approval and registration program on  data quality.

V    Cost and Level of Efforts Estimates

     No information is currently available in  this area.
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             CALIFORNIA, STATE DEPARTMENT OF PUBLIC HEALTH
                       WATER LABORATORY APPROVAL

I    Background

     A. Nature of Program

        The Public Health Department approves both commercial  and
        non-commercial  laboratories for the performance of bacteri-
        ological and chemical  tests on water.  Any laboratory  engaged
        in these tests  is required to obtain such approval  from the
        State.

     B. Authority

        The California  Administrative Code.   Chapter 2, subchapter 1,
        Group 6, Sections 1174-1184 inclusive.

     C. Objective

        To assure a level of reliability of data on water quality
        which will  safeguard the State's water  supply and enable the
        Department of Public Health to carry out its responsibilities.

II The Certification Process

     A. Scope

        State Public Health  Department employees are responsible for
        the approval  of approximately 450 laboratories.   Nearly one-
        third of these  were  visited in 1974 for reapproval  and about
        25 laboratories were evaluated for initial  approval.

        The program is  currently financed by a  grant from EPA  in the
        amount of $116,000.   These funds, which are disbursed  by the
        California  Water Resources Board, are being used  to expand
        the staff of the Laboratory Services Division of  the Public
        Health Department in order to augment both  the scope and
        expertise of the Division.
     B.  Laboratory Elements  Evaluated

        Facility

               housing
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               equipment and  apparatus

               supplies

        Procedures

               sample analysis

               recordkeeping

               reporting

        Personnel

               qualifications of supervisory  personnel  are  examined

     C.  Certification Procedures

        After an application  for approval  is  submitted  by a laboratory
        within the  State, the laboratory must perform successfully on:

               an on-site visit

               analyses  of reference  samples

        in order to be approved.

        Maintenance of approval  requires the  following:

               annual bacteriological reference  sample  tests

        Renewal  of  approval of laboratories,  including  on-site visits,
        will  be required every three  years under the new EPA funded
        program.

Ill  Identified Problem  Areas

     Problems associated with the implementation and effectiveness of
     the approval program as  revised  and expanded with  the  use of EPA
     funds are not  yet identifiable because the  program has so recently
     been restructured.   (Note:   The  program  which will  be  implemented
     with EPA support is the  one synopsized here.)  Problems of the
     previous program, which  this new structure  is designed to alle-
     viate, can be  grouped into  two categories:

        .  Problems associated with the use of inadequately trained
           staff.   This  is especially an issue where chemical  analyses
           must be  evaluated  by  this  staff because knowledge in the
           field of chemical  analysis techniques is incomplete.
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        .   Problems associated with a numerically inadequate staff.

IV   Program Administration and Evaluation

     The laboratory approval program is administered by a professional
     staff of five chemists.  These chemists have a variety of
     responsibilities,  the most significant of which is their role as
     laboratory evaluation officers.

     The Health Department relies principally upon the results of its
     participation in the EPA reference sample program administered
     from NERC-Cincinnati for an evaluation of its technical  capability
     to assess test results from laboratories which it accredits.  In
     addition, the overall approval program was recently evaluated both
     by EPA and by the Department itself when EPA funds were made
     available and designations for their use were necessary.

V    Cost and Level of Effort Estimates

     The laboratory approval program is funded principally through the
     EPA grant referenced above.  This grant of $116,000 provides support
     for four chemists and microbiologists, one laboratory assistant and a
     clerk.   In addition, the  State  provides approximately $20,000 per
     annum  for an  additional chemist.

     The program director estimates that, under the approval  program as
     it is being revised, about one man day will  be required for an  on-
     site evaluation of a single laboratory.   Manhour estimates for
     other aspects of the approval  program were not available.
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             CALIFORNIA, STATE DEPARTMENT OF PUBLIC HEALTH
                     CLINICAL LABORATORY LICENSURE

I    Background

     A. Nature of Program

        The Public Health Department licenses all  commercial  clinical
        laboratories in the State,  except those directly owned and
        operated by a licensed physician or surgeon for work  performed
        on his own patients.

     B. Authority

               California Administrative Code,  Title 17, Chapter 2,
               Subchapter 1,  Group  2.

               California Business  and Professions Code, Division 2,
               Chapter 3, Sections  1200-1322.

           (Additional authority for laboratories  participating in  the
           Medicare program is provided by Social  Security Administra-
           tion regulations.)

     C. Objective

        To assure the capability and satisfactory  level  of performance
        of facilities and personnel  engaged in  the provision  of
        clinical  laboratory services.

II   The Certification Process

     A. Scope

        At present about 2,000 laboratories  and 22,000  laboratory
        personnel  are licensed under the program.   There are  also about
        8,000 physicians'  office laboratories which are currently
        required to participate in  an  approved  proficiency testing  pro-
        gram, although they are exempt from licensing as such.

     B. Laboratory Elements Evaluated

        Facility

               work bench space

               work area arrangement

               ventilation
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               storage of  volatile chemicals

               safety precautions

        Procedures

               record keeping

               internal  quality  control  (written  program  is required)

           Note:  Analytical methods are 'not specified.

        Personnel

               education,  training and  experience are all evaluated
               on the basis of detailed criteria  established  for a
               variety of  work categories.

     C.  Certification Procedures

        An application for a license is submitted by the  applicant
        together with a  fee of $100.00.  Licensing requirements include:

               favorable evaluation of  facility by licensed State
               survey personnel

               licensed  status of laboratory personnel

               enrollment  in a State approved  proficiency testing
               program

        Licensing of both  the facility  and  personnel is subject to
        annual  review.

Ill  Identified Problem  Areas

     Most of the problem areas identified,  such as the  inability to
     conduct on-site visits with desired frequency, were  traceable to
     funding limitations.

IV   Program Administration and  Evaluation

     In  addition to its  direct .licensing function, the  State  agency  also
     issues guidelines to  laboratories  operating  under  its jurisdiction.
     These guidelines are  generally addressed  to  the goal of  laboratory
     improvement and deal  with various  specific topics  such as manage-
     ment practices, personnel,  laboratory  performance  control and
     evaluation and other  germane areas.
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Because the agency lacks an adequate capability for review of
proficiency testing data (available statistical and computer
services are quite limited), its competence to review the
effectiveness of its licensing program is severely restricted.

Cost and Level of Effort Estimates

Exact cost figures were not available.   However, for Fiscal  Year
1974-1975, a total of $465,199 was budgeted for an average of
37.8 positions.  A budget prepared in 1970 showed the following:

   Estimated Expenses

      Salaries (31 persons)                $ 194,568
      Travel                                   6,963
      Statistical  services                     30,081
      Data processing                         18,237
      Directory                                7,500

                                 Total      $ 257,349

   Estimated Income

      Clinical laboratory fees             $ 147,700
      Personnel licenses
          trainees                             9,168
          technologists                       133,593
          bioanalysts                         14,052
                                 Total      $  304,513
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PRIVATELY OPERATED CERTIFICATION PROGRAMS
                   132

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               AMERICAN INDUSTRIAL HYGIENE ASSOCIATION

I    Background

     A.  Nature of Program

        AIHA accredits laboratories which perform analyses  both of air
        samples from the workplace and  of biological  specimens  related
        to exposures in the work place.   Program planning was  initiated
        in October 1970 and the current operation is  supported  by  a con-
        tract by NIOSH.  A full  accreditation  program was in force as  of
        January 1974.

     B.  Objective

        To foster improvement in the performance of industrial  hygiene
        laboratories.

II   The Certification Process

     A.  Scope

        The AIHA performs either directly or through  contracted services,
        the following  program operations:

               The establishment of standards  against which laboratory
               procedures and practices  are to be assessed.

               The identification of the elements of  laboratory facili-
               ties and operation to be  assessed and  the methods for
               their assessment.

               The evaluation of applicant laboratories and their  per-
               sonnel .

        AIHA retains full  responsibility for the approval of laboratories
        evaluated.   (Thus,  although proficiency testing was performed
        by NIOSH and privately contracted,  AIHA uses  the results of these
        tests to make  decisions  regarding  laboratory  accreditation.)

        Participation  in the AIHA accreditation program is voluntary.
        Currently,  approximately 160 applications have been requested
        and about 60 returned,  of these  32 have been  approved.  The re-
        mainder of the applicants will  be  evaluated following completion
        of site visits  to the laboratories.

     B.  Laboratory Elements  Evaluated

        Facility

               space design

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               ventilation
               services
               Safety equipment
               other equipment and apparatus
        Procedures*
               quality control procedures
               safety procedures
        Personnel
               qualifications are specified for:
                  laboratory director
                  laboratory supervisor
               qualifications and duties are specified for:
                  industrial hygiene technologists**
                  industrial hygiene technicians**
        Records
               record system for each sample
               records of checking system for calibration and
               standardization of equipment and of internal
               control samples
     C. Certification Procedure
        .   Laboratory submits application for accreditation  to AIHA
*   It is the view of the Association that the specification of detailed
    test procedures tends to inhibit innovation.   For this reason intern-
    al quality control  methods,  rather than procedures are examined by
    the AIHA.  Also, the validity of analytic procedures is assessed
    through proficiency testing  in any case.
**  The difference between a technologist and a technician is that a
    technologist must have a baccalaureate degree.
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        .  AIHA examines the qualifications of the applicant
           laboratory by:

               .  reviewing the application submitted

               .  enrolling the laboratory in the PAT (Proficiency
                  Analytical Testing) Program of NIOSH and review-
                  ing the results of tests made

               .  performing on-site visit to the laboratory

        .  AIHA accredits those laboratories which meet its require-
           ments for a period of three years.  Reaccreditation is based
           on a new application or a certification that original  appli-
           cation is still valid (that is, if no changes in the labora-
           tory organization and personnel have occurred).

        .  Satisfactory PAT tests and results of annual  on-site visits
           are required to maintain accreditation.  PAT performed every
           two months.  (NIOSH contracts out testing now - will be
           every three months.)

Ill  Identified Problem Areas

     Only problems associated with the initiation of the accreditation
     program are currently identifiable.

IV   Program Administration and Evaluation

     The laboratory accreditation committee is composed  solely of labora-
     tory directors and supervisors who have in-depth knowledge in the
     field of industrial  hygiene.  It is the view of the AIHA coordina-
     tor, who is also a technologist, that it is equally important for
     the Committee evaluators (who review PAT test results and on-site
     evaluations) to be technically knowledgeable as it  is for those
     who actually perform the sample analyses and on-site evaluations
     on which the Committee decisions are based.

     AIHA is aware of the need for continuing evaluation of the adequacy
     of its program.  However, because a program of this nature,  unlike
     that of a laboratory, for example, is not amenable  to internal
     evaluation by means  of quality control  or similar measures,  AIHA
     perceives the need for a separate and independent evaluating body
     for the performance  of this function.

V    Cost and Level  of Effort Estimates

     The AIHA accreditation program is designed to be self-supporting on
     a non-profit basis.   Laboratory fees for accreditation services
     (ranging from $50.00 to $300.00 exclusive of application fees)  are

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     intended to cover the costs of providing all  services  except for
     site visits.  The level  of effort which will  be required when the
     program is fully operational  is not yet known.   At present,  the
     annual cost of the coordinator's operation,  including  personnel  and
     overhead, is about $50,000 annually.  The estimated average  site
     visit cost $350.00 (including compensation).
VI   Comments
     AIHA has entered in an agreement with the Health Physics  Society
     under which the Society will  participate in the laboratory accredi-
     tation program.  It is anticipated that 3 members of the  Society
     will become members of the Laboratory Accreditation  Committee and
     that other members of the society will  serve as regional  repre-
     sentatives, laboratory appraisers or site visitors to health  phys-
     ics laboratories.

     In addition to its contract arrangement with NIOSH referenced above,
     AIHA relies heavily on information generated from laboratory  par-
     ticipation in the  NIOSH PAT program and, in conjunction with  NIOSH,
     conducts courses relating to  the establishment  and accreditation of
     industrial hygiene laboratories.

     AIHA is currently  trying to establish a reciprocal certification
     agreement with the Center for Disease Control.   To date,  however,
     only some preliminary discussions have been held.
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               AMERICAN SOCIETY  OF  CLINICAL  PATHOLOGISTS
                 AND COLLEGE  OF  AMERICAN  PATHOLOGISTS
I    Background
     A.  Nature of Program
        The American Society  of  Clinical  Pathologists  (ASCAP),  through
        its National  Committee for  Careers in  the  Medical  Laboratory,
        certifies laboratory  personnel.   The College of American  Path-
        ologists  inspects and accredits both independent and  hospital
        laboratories.
     B.  Objective
        Programs  of both organizations are designed to develop  and  imple-
        ment the  highest possible standards  in the practice of  labora-
        tory medicine.
II   The Certification  Process
     A.  Scope
        The ASCP  certification program includes an assessment of  both
        academic  and experiential qualifications of clinical  laboratory
        personnel.   In  addition, the  program uses  proficiency examina-
        tions to  further evaluate personnel  capabilities.
        The College of  American  Pathologists (CAP) certifies  approximately
        8,000 laboratories.   Its inspection  and accreditation program
        relies principally on proficiency testing  and  on-site evaluations
        for laboratory  accreditation.  As an independent organization,
        its program is, of course,  voluntary.
     B.  Laboratory Elements Evaluated
        Facility
               offices
               patient  services  area
               library, conference  rooms, etc.
               inventory and  supplies storage
        Procedures
               Detailed procedures  are examined in the following  testing
               areas:
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               hematology
               chemistry
               urinalysis
               microbiology
               blood bank
               diagnostic immunology and syphilis serology
               nuclear medicine
               anatomic pathology and cytology
        .  Specimen collection procedures
        .  Safety procedures
        .  Water sterilization and purification
        .  General recordkeeping
        .  Quality control programs*
     .  Personnel
        Personnel policies of the laboratory are examined (e.g., admini-
        strative organization and personnel responsibilities).
     C. Certification Procedure
        ASCP Certification
               ASCP certifies medical personnel in the following cate-
               gories:
               .  laboratory assistant
               .  medical laboratory technician
               .  medical technologist
               In addition it grants special certifications in the fol-
               lowing test areas:
*  This program includes an examination of the maintenance and reliabil*
   ity of procedure manuals.
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            .   blood banking

            .   chemistry

            .   microbiology

            .   hematology

            .   nuclear medical  technology

            .   cytotechnology

            .   histology

                          for certification in each of these areas
            include various combinations of the following:

            .   academic degree(s)

            .   experience

            .   successful performance in the applicable proficiency
               exam(s)

     CAP Inspection and Accreditation

            Laboratory submits necessary application forms  and en-
            rolls in proficiency testing program.   In addition it
            must notify CAP that its supervisor is certified by the
            ASCP.

            CAP regional commissioners are notified of an applica-
            tion within their region and appoint appropriate volun-
            teer inspectors

            An announced on-site visit is performed during  which the
            laboratory elements identified in part II B are inspected
            and evaluated.

            On the basis of the on-site visit (including applicant's
            responses to questions asked*) and the applicant's parti-
            cipation in the proficiency testing program, the CAP
The questions used in the on-site evaluations fall  into three phase
categories.  Phase "0" questions relate to detailed points of infor-
mation.  While the considerations involved may be used by a labora-
tory for self evaluation, they are not essential  to the certification
process.  Phase I questions address issues which  are somewhat more
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              makes its decision.

              Maintenance of certification requires that the laboratory
              continue to demonstrate proficiency (quarterly) in a
              quality evaluation program.

              CAP certification is valid for a two year period at the
              end of which an on-site visit is scheduled.

              In years when no on-site inspection is scheduled, labora-
              tories are provided with a CDC computer processed check
              list  for self evaluation.

Ill  Identified  Problem Areas

     None was identified by  CAP personnel.

IV   Program Administration  and Evaluation  (CAP)

     The Inspection  and Accreditation activities  of  the  CAP central  of-
     fice require a  staff  of approximately  four persons.   This  staff
     provides support and  background  information  to  a central  Board  ot
     Commissioners which makes all  decisions  regarding  the accreditation
     of individual  laboratories.   The Commission  also  includes  ten re-
     gional commissioners  who, in addition  to their  own  activities,  re-
     cruit volunteers to  perform  on-site  visits.   The  College relies
     principally on  the quality of the data generated  by laboratories
     it accredits to evaluate the effectiveness of its  program.   Labora-
     tory data resulting  from split sample tests  has shown up no major
     problems in the program to date.  Minor deficiencies noted by lab-
     oratory personnel, inspectors, etc.  are brought to the attention
     of the Commission for remedial action.

V    Cost and Level  of Effort Estimates (CAP)

     Accredited laboratories are billed for CAP services according to
     the number of  separate disciplines or categories for  which they are
     accredited  (e.g., chemistry,  hematology,  etc.).  The  fee schedule
     is  as follows:

         .   1-4 disciplines       $125 per year
    significant but which  are  not certification criteria.  Phase  II
    questions address  criteria which directly  relate  to accreditation
    eligibility.
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        .   5-8 disciplines       $200 per year

        •   9 or more disciplines $200 per year plus $50 per year for each
                                 additional four disciplines or portions
                                 thereof
VI   Comments

     Relationships With Other Organizations (CAP)

     .   The CAP program has been approved by the Center for Disease
        Control (CDC) as equivalent to Federal  licensure under the
        Clinical  Laboratories Improvement Act of 1967  with the pro-
        viso that CAP perform annual  on-site inspections of those
        laboratories who use CAP for CDC equivalency accreditation.
        This approval is maintained through a procedure in which CDC
        performs  annual random checks on 10% of those  laboratories
        accredited by the College.   The College's  inspection and
        accreditation program not only meets the standards of the
        CDC but also of the Food and Drug Administration and of the
        Joint Commission on the Accreditation of Hospitals.
                                  141

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                 APPENDIX II





EXAMPLES OF FORMS USED IN PROGRAMS REVIEWED
                      142

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                               INTRODUCTION
This Appendix contains reproductions of forms  used by some of the
certifying organizations surveyed in this study for various purposes,
such as applications for certifications and laboratory evaluations.
                                    143

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                       HEW, FDA,  BUREAU  OF FOODS*
*  These forms apply to the milk analysis  laboratory  certification
   program.
                                   144

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DEPARTMENT  OF  HEALTH. EDUCATION,  AND WELFARE
PUBLIC HEALTH SERVICE
Survey  Form  for  Milk  Laboratories
                                                              PHS-I50M
                                                              (Rev. 5-45)
  Indicating conformity with the Pasteurized Milk Ordinance —
  7565 Recommendations of the  United  States Public Health
  Service
SURVEY BY
LABORATORY
X=DEVIATION
LOCATION
U=UNOETERMINED O=NOT USED
DATE
                                                                 SAMPLING
                             APPARATUS
  I. Thermometer  	
    Mercury filled (or having a distinctively colored fluid with freez-
       ing point less than  +30eF). or dial type 	
    Graduation interval not to exceed 2° 	.".	
    Suitable range. 0-220eF. or shorter-scale if satisfactory 	
    Accuracy checked with thermometer certified by National Bureau
       of Standards,  or one of equivalent accuracy	
    Periodically recheck thermometers for accuracy	_	
  2. Agitator  	-	
    Metal  disc  (6"  diameter on  end of metal rod long enough  to
       reach  bottom of container) 	
    Or bowl-type  (3" diameter.  I" deep, welded to  30" solid metal
       handle), with pouring spout at 90" angle from  handle	
  3. Sample transfer instrument	-
    Seamless metal tube (aluminum preferred. 24" by 'A" I-D.) —
    Or metal dipper  with long handle, capacity  10 ml	
    Or single-service  paper sampling tube	
    vOr ofhor means for removing  sample asepticolly	
  4. Sampling  instrument  case 	
    Box to  protect instruments during and  after sterilization, metal
       preferred, tight cover	
  5. Sample containers, sterile	
    Clean and dry. 0.5-1.0 oz. (optionally 2-8 oz.) 	
    Suitable place for identification of sample	
    Screw-cap  vial or  bottle top  ground or molded smoothly 	
    Loaltproof closure  (do not use cotton plugs) 	
    Corrosion-resistant metal or satisfactory plastic cap  	
    Proper  skirt length to  be leakproof 	
    With  rubber liner in non-toxic plastic or metal cap	
    Or sterile evacuated equipment for collecting 10-ml  portions 	
    Or presterilized suitable  non-toxic plastic begs, adequate size ..
  6. Cooling bath 	
    Provided where samples not cooled promptly in sample case . ...
    Adequate to cool samples promptly and keep at  32-40°F	
    Provided  where  necessary with  racks,  compartments,  and/or
       baffles to hold  sample bottles vertically 	
    To keep neck of bottles above surface of cooling  medium ...
    To maintain cooling medium above height of sample, and 	
    To allow sufficient ice and water, or other refrigerant	
    Optionally, use to transport samples to laboratory    	
  7. Sample case 	
    Rigid metal, plastic (or metal-lined wood) 	
    With or without  insulation, ample space for  samples, and 	
    For sufficient  cracked  ice or other refrigerant to  cool  samples
       promptly to and keep  them at 32-40°F 	
     Neck of bottles above surface of cooling  medium ...
     Unless containers are sealed or under continuous supervision until
       proper  handling during transportation,  attach  handles  and
       label "This Side Up" to top of case	...
10.
 8.  Inner shipping cote (for small sample vials) ...
                       PREPARATION
Cleaning sampling equipment	-
Rinse sampling instruments immediately after uso in tap water .  . _
Clean instruments  in hot  water  containing soapless  detergent.
  alkaline phosphate, or other suitable material  (avoid excessive
  exposure to strong alkali)				_
Use suitab'e brush  to clean inside of lubes  or containers 	_
Immediately after treatment, rinse instruments  thoroughly 	_.  . _
Plastic caps, before first use, autoclaved twice while  submerged
  in  water, or mechanically washed with suitable detergent above
  I80°F,  or  equivalent  procedure  	_	_
Laboratory sterilization of sampling  equipment  	—
Sterilize whenever possible with dry heat	_
At not less than  I70°C. for not less than I hour 	_
Load properly distributed, sterilizer not overloaded	 _
Or autoclave aluminum tubes and  materials  that are  likely to be,
  charred at I2I°C for not less than  15 minutes	_
Practical sterilization  of sampling equipment	_
For practical sterilization of stirrer, campling tube,  or  dipper be-
  tween samples, rinse first in one can of clean water (50-80*F)
  connected with a continuous  flowing source  	_	    _
Then submerge in a second car. of water kept continuously at not
  less than I80°F for at least  I minute, or		 _
Submerge in a hypochlorite solution maintained  at not less than
  100 ppm for at  least 30 seconds  (or use other  halogens bac-
  tericidally  equivalent)  		_
II.
12.
                  SAMPLING  PROCEDURE
Directions applying to  both raw and pasteurixed samples _
Take samples at sufficiently frequent  intervals  to  determine if
  supply continuously conforms  to  prescribed standard 	_
Promptly identify each  sample legibly  and indelibly with official
  number, label, or tag		—	_	-
Cool immediately and maintain at 32-40'F (avoid freezing) 	—
Where necessary transfer to shipping case (at 32-40°F) 		
Use adequate insulation during cold weather to prevent samples
  from freezing	_
Provide extra sample of milk or milk product for temperature con-
  trol from first sampling  point and 	-
Record temperature of  milk et all sampling locations		 _
Record time and date of sampling  		_
Protect samples at  all times from potential contaminants 	'_
When sampling  is complete, promptly deliver to laboratory 	 _
Where results may be  used in court, apply official seal to con-'
  tainer and deliver to analyst, or  seal  or lock sample case and
  ship intact	 _«........................	—
                                                                        145

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                SAMPLING PROCEDURE (Continued)
13. Additional directions for sampling raw milk for pasteuriiation
       (Also see Item 15 for farm bulk tonlts, item  16 for weigh vats,
       item 17 for milk cans, and item 18 for storage tanks) 	 -
    Sample milk not partially frozen,  lumpy, curdled, or churned — -
    Use practical sterilization, as needed, for sampling equipment	_
    Preferably, determine  strength of sanitizing  solution with appli-
       cable test kit	_			-
    Sanitize thermometer before insertion into milk	-
    Tank or vat thermometer in  good repair, and  	-
    Checked for accuracy against a certified thermometer  or one  of
       equivalent  accuracy  (see  item  I) 	-
    Take representative samples of producer's and/or dealer's milk .. .
    Thoroughly mix milk immediately before sampling	 _
    Use stirrer long enough to reach bottom of milk can or  weigh-vat
       or  tank	_._...........................	................._................... -
    Where necessary to sample  previously opened containers, such  as
       milk cans or weigh-vats, agitate by sterile stirrer or any already
       in container ........ .._............„.....	 -
    Hands should  be clean and dry during sampling operation 	 .
    Use sterile sampling tubes or dippers, or	
    Remove  dipper or sampling  tube fron sanitizing  solution  and
       rinse twice in  milk before transferring sample 	    .. -
    When a sampling tube is used, insert it, not too rapidly, to  bot-
       tom of container with top of tube left open	
    Place finger over open  end, withdraw tube, and aseptically trans-
       fer contents to sterile sample container	
    Use separate sterile tube or dipper for each  sample	
    Transfer  from 5-10 ml  to sterile, preferably precooled, sample
       *
      container 	-
    Or, if necessary, aseptically catch  sample in sterile receptacle
       as well-mixed liquid is poured from container	
    Handle sterilized sample  bottles  and closures  aseptically 	-
    Fill sample containers not more than % to % full  	-
14. Precautions In sampling raw milk for pasteuriiation	
    Do not use metal  disc  or bowl-type agitator to mix milk  in sta-
      tionary storage tanks  or tanks on trucks	 -
    Protect  sterile  sampling instruments from unnecessary  exposure
      before  use  				-
    Do not drop or lay sample bottle caps down	-	-
    Do not touch or otherwise contaminate  inner surface of caps ...  -
15. Row  milk for  pastenrhotion  samples  — bulk  tanks only .
    If milk height stick is removed from tank before sampling, sanitize
       prior to reinsertion into milk		-
    Operate agitator for at least 5 minutes prior to taking sample  .
    For each  installation, when  installed and periodically thereafter,
      and at older installations, determine agitation needed by test-
       ing 2 or more suitable sub-samples for butterfat  (mean  should
      not vary more than 0.1%)  		 -
    Optionally, test sub-samples from first and  last gallon  of  milk
      and periodically between  (20, 40,  60, and  80%)  or equivalent -
    Agitation  procedure results  available at each installation 	  .
    During transfer of milk sample, do not hold  container  over  milk
16. Raw milk for pasteuriiation samples — weigh-vats only	
    For routine  control,  remove  representative samples immediately
      after milk is dumped and  mixed 	
    Collect sub-samples to determine proper agitation  (ime  (see  15) .
    If weigh-vat is not large enough to contain milk from producer,
      collect proportionate amount  of  milk From  each  filling	
    Drain  weigh-vet  between successive  deliveries so that  residual
      milk does  not exceed approximately I  Ib  	
    Avoid use of strainers or other equipment in such manner that
      they unduly contaminate or interfere  with mixing	
    Routinely rotate  use  of 2 or  more tubes or dippers subjected to
      practical sterilization, as described in item  II  	
    Optionally, reuse same instrument,  provided at least  I minute  is
      allowed for practical sterilization between samples	
17. Raw milk for pasteurization  samples — milk cans'only  	
    Rotate use  of 2  or more sampling tubes or dippers, or optionally
      reuse  seme instrument, as described in items II and 16	
    When sampling  from one  producer,  optionally use same instru-
      ment  and omit rinsing and sterilizing steps between cans     . .
    Collect proportionate or random samples from producer milk cans
18. Raw milk for pasteuriiation samples — storage tanks only ,
    Use odor-free, pressurized  filtered  air,  or  electrically  driven stir-
      ring  equipment, or recirculation  (all equipment sanitized  be-
      fore  use  in each successive tank where  applicable)	,
    Collect  sub-samples to determine proper agitation  time (see  15) .
    Collect  sample  from sampling cock on  storage tank  access door
19. Pasteurized milk and  milk product  samples   	
    Take representative sample of each milk  or milk product as  de-
      livered to consumer  	 ... _	_
    Preferably  collect samples from delivery  trucks or retail  stores
      while  still in possession of  processor  	,
    Periodically sample each size and style  of  container	,
    Or, if necessary, after thoroughly  mixing  contents in container,
      aseptically transfer representative  portion  to  sterile container
    Or from mill dispensers, collect sample direct from  spigot with-
      out sanitizing  or flushing spigot opening	,
    Otherwise,  collect samples, as described in item 12	
    When shipping,  protect caps  and lips by tightly fitted, waterproof-
      cover (protect paper containers from crushing)
20. Laboratory procedures  	
    Record temperatures  of samples on receipt at laboratory 	
    Determine temperature of samples  by inserting thermometer into
      separate  pilot container  treated  exactly  as  sample	
    Do not insert thermometer into any sample intended for bacterio-
      logical examination before removal of test  portion	
    At laboratory, store samples at 32-40°F  until tested	
    Record time and date of analyses		
    If chemical tests  are also to be made, aseptically remove  portions
      for  bacterial   analysis  first 	
    When examining gassed  or  pressurized samples at  laboratory,
      freeze contents solid  by  exposure in  deep-freeze cabinet, then
      vent and  allow gas to escape before 	_	
    Transferring  contents,  aseptically, to sterile container 	
    Periodically, determine  sterility  of  sampling instruments,  by rins-
      ing  asepticall/ with sterile buffered  water without  neutralizer
      end plating portions 	
                                                                           146

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 DEPARTMENT  OF HEALTH,  EDUCATION,  AND  WELFARE
.JBLIC HEALTH SERVICE
  urvey  Form   for  Milk  Laboratories
                                                              PHS-ISOO-2
                                                              (R«v.5-45)
  Indicating conformity with the Pasteurized Milk Ordinance —
  196)  Recommendations of the  United  States Public  Health
  Service
JRVEY BY
ABORATORY
X=DEVIATION
LOCATION
U=UNDETERM[NED O=NOT USED
DATE
                              CULTURAL  PROCEDURES — GENERAL  REQUIREMENTS
                            APPARATUS
  I. Work area 	
    Level table or bench, ample plating surface	
    In clean, well-lighted, well-ventilated room, reasonably free from
      dust and drafts .... -			
    Microbic density of air less than 15 colonies/plate in 15 minutes.. .
  2. Storage space	.,	
    Cabinets,  drawers,  or shelves  adequate for protection  of glass-
      ware,  apparatus,  and other materials (especially when sterilized
      equipment is not used immediately)  	_	,
  9. Thermometer 	_	
    Appropriate range  0-220° F or shorter scale range	
    Graduation interval not to exceed  2°
    Accuracy  checked  with  thermometer  certified by National  Bu-
      reau of Standards, or  one of equivalent accuracy, or 		
    Optionally use automatic temperature-recording instruments .  .. .
    Periodically recheclc thermometers  for accuracy	_	
  4. Refrigeration	
    Sufficient to keep samples at 32-40" F until tested 	
  5.'Pipettes	
    Walls straight, tips  ground to deliver APHA specifications	
    Delivery  1.0 ml, I.I  ml for  successive  O.l-ml and  I.O-ml de-
      liveries without recharging, or 11 ml if needed  	
    Graduation distinctly marled  with contrasting pigment 	_. .
    Use  unbroken pipettes; discard those with broken  tips	
    Pipettes recalibrated if required for regulatory work (such recall-
      bration  desirable under all conditions)  —	
  6. Pipette contolnors	_...	_			
    Use for sterilization, storage, and handling —	
    Box,  metal preferred, 2-3" x  16" .(optionally use paper wrappings).
  7. Dilution bottloi 	_	
    Bottles, resistant (preferably borosilicate) glass 		_	
    Tops ground or molded smoothly		_	
    About 6 oz, marked indelibly at 99 ± I  ml graduation level  (or
      otherwise for special  purposes)  		
    Closed with rubber stoppers  (not cotton plugs)  or  corrosion-
      resistant metal or suitable plastic screw caps 	
    Caps proper length for lealcproof contact, suitable liner	
    Plastic caps, before first use autoclaved  twice while  submerged
      in  water, or mechanically washed with suitable detergent  at
      not less than 180° F, or equivalent procedure	
    Caps in  u;e free from toxic substances	-	
    Use new liners as required to make closure leekproof .
  8. Potrl dishes (glass or plastic)  	 •
    Outside diameter 100 mm, depth IS mm,  with flat bottoms	
    Free from bubbles, scratches,  or other defects 		
  9. Petrl dish container*	_	-	
    Used to protect and handle before and after sterilization 	
    Metal boxes with  covers, coarsely woven  wire baskets, or char-
      resistant paper sacks or wrappings ,
10. Hot-air iteriliiing oven ._	  ,
    Size sufficient to prevent crowding of interior		,
    Constructed  to give uniform and adequate sterilizing  tempera-
      tures (check temperature variations within oven) 	
    Equipped with thermometer, suggested  range 0°  to 220" C	
    Vents located to assure prompt and uniform heat penetration	
11. Autoclave	  ,
    Sue sufficient to prevent crowding of interior 	
    Constructed  to provide uniform end  adequate temperatures 	,
    Equipped with accurate thermometer with bulb  properly located
      to register minimal temperature within chamber 			,
    Prsssure gauges end properly adjusted  safety valve
    Connected with suitable saturated steam line, or to gas or electri-
      cally heated steam generator	
    Small  pressure  cookers may be substituted only in  emergencies
      end only where satisfactory results  ero obtained 	
12. Incubator	,
    Ei*her  water-iacket  (filled]  or anhydric type, with low-tempera-
      ture, thermostatically controlled electric heating units properly
      located and insulated in or adjacent  to walls or floors 	
    Provided with shelves so spaced as to assure uniformity at 32° C,
      or other temperature as needed	..
    Determine temperature  variations within  incubator when  filled
      with poured plates to maximal capacity	_	_
    Avoid  use of anhydric incubators with inside dimensions less than
      20"  x 20"  i 24" high  (or equivalent space) ....
    Keep whero temperatures do not vary excessively (50-80°F)
    Away from outside walls, windows, end drafts ...
13. Incubator room  		  ,
    Optionally use walk-in rooms, well insulated, equipped with  prop-
      erly distributed heating units and forced-air circulation 	.
    Provided areas  conform to  desired temperature  limits _		,
    Record daily range in temperature in  areas  used for plates . 	
14. Colony counter	_	
    Quebec colony counter, dark-field model preferred
    Or one providing equivalent  magnification and visibility
15. Hand tally  	_	_	
    A mechanical counting device, of convenient type .
16. pH meter, or colorimeter with standards ...
    Dependable potentiometer, or accurate color standards 	
17. Media-mailing utensils 	_....  ,
    Pyrex,  stainless steel, or other noncorrosive equipment 	,
    Clean  and free from foreign  residues  (as dried egar)  and from
      toxic or foreign materials which  may  contaminate media  (such
      as chlorine, copper, zinc,  aluminum, antimony, or chromium)  ...".  .
18. Bolance	«.......»»................«...«_  >
    Sensibility  reciprocal 53 mg. with weights as required			.
19. Water bath, or incubator	_	
    Thermostatically controlled at 44-46* C .......
    Of appropriate size for holding melted  medium
                                                                      147

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                              MATERIALS
20. Diililled water	 -
    Distilled water used  (or all media, reagents,  blanks, etc	-
    Tested periodically for freedom from toxic contaminants 	   _
21. Dilution water 	 -
    Use phosphate buffered distilled water for dilutions 	-
    Stock buffer correct formula,  properly diluted  	
    Optionally autoclave stock buffer and store  in refrigerator ..   . -
    Test periodically for toxic substances by replating a  series of milk
      dilutions at  intervals of 10.  20, 30. and 45 minutes	-
    Do not use if abnormally high mineral content or if toxic	 -
    Neutralize distilled water if free chlorine is present	  -
22. Reagent chemicals and fermentable carbohydrates	
    Highest purity unless otherwise specified  	  -
23. Pancreatic digest  of eaiein (USP)	-	 -
24. Yea»t extract	 -
25. Agar	 -
    Bacteriological grade, granulated or chopped,  of  best quality .  _
    Practically free from thermophilic bacteria     	
    Check microbial contamination (not over 50  colonies/2g)	
26. Standard Method* agar	
    Brand    	 catalog  No	 lot No	

                             PREPARATION
27 Cleaning plpettei  	
    Preferably rinse immediately after use in water at  15-30° C	
    After rinsing, thoroughly wash with soapless detergent, an alkaline
      phosphate, or other suitable material	
    Rinse until all detergent residues are removed	
    Optionally at weekly or biweekly intervals,  soak  pipettes for 24
       hours in strong  cleaning solution 	
    Wash acid-treated  glassware  thoroughly in alkaline waters  end
       then repeatedly rinse in clean water	     •-  -
    Before use. test several pieces in each  batch for residual acid or
       alkali,  with  appropriate indicator  (bromthymol  blue)  ..    .   .
28. Cleaning ether glassware  	
    Thoroughly wash  with suitable detergent	
    Rinse thoroughly  in  clean water	
    Residual acid or  alkali not present	
    Test glassware for freedom from bacteriostatic detergent residues .
29. Sterilixatien of equipment  	
    Sterilize  whenever possible with dry heat	
    So center of load is not less than  170" C. for not  less than  I hour .
     Do not crowd oven (cover only 50-75% of shelf area in gravity
       ovens. 90%  in  mechanical convection) _	
    When  loaded to  capacity  preferably  use  longer periods  or
       slightly  higher  temperatures 	
     Where sterilization  may be questionable, or  where record may be
       required for testimony, record time  oven reaches sterilization
       temperature, minimal temperature used, and time of discontinu-
       ing heat for each lot  of  materials 	
 30. Sterilization of  dilutions, media, plastics, etc.
     Autoclave dilutions, media,  and materials likely to char	
     At 121° C for 15 minutes (20 minutes for water  blanks)	
     Apply minimal heat to insure sterilisation 		
     Slightly loosen stoppers to permit passage of steam and air	
     Force all air from sterilizer before allowing  pressure rise
     Should reach 121*  C within  10 minutes after  exhaust	,
     Rely only upon   a  temperature registering  gauge, preferably a
        mercury-filled  thermometer of predetermined accuracy	
    Occasionally  or  routinely  use time-temperature indicator . ...
    Avoid overloading autoclave .  -	  -
    For nonliquid materials, or where packing arrangement or volume
      of materials  retards  penetration, allow longer time  to  reach
      121 ° C, or sterilize longer 			   -
    After sterilization reduce pressure with  reasonable promptness ... -
    Remove media  from autoclave 		-	
    Where sterilization may be  questionable or  record may  be  re-
      quired, record time autoclave reaches sterilization temperature,
      minimal temperature  used, and fime of discontinuing heat    .  _
31. Dilution blanks	
    Filled so after sterilization  will contain 99 (or 9) ml 	-
    After sterilization  but  before use observe amount in each blank
      and  discard those exceeding ± 2 percent	
    Predetermine approximate  amount  required before  autoclaving .. .
    Optionally  use   correctly calibrated automatic measuring  device .
    When  using  bulk  sterilized diluent, measure  directly into  sterile
      containers, end  use  prepared blanks  promptly 	
32. Agar  preparation 	
    Preferably  use  dehydrated medium of  correct composition 	
    Or prepared from specified ingredients (USP casein digest, yeast
      extract, glucose, best quality agar) in  correct amounts	
    If prepared from  ingredients, analysts must  assume responsibility
       (periodical records  demonstrating equivalence)	
    Keep containers tightly closed 	-
    Discontinue use if materials show contamination or decomposition .
    Check 10%  solution of protein digests for  microbic contamina-
       tion by Gram stain of 0.01  ml (bacterial limit-  10  per  10  fields) .
    Medium prepared with distilled water	
    Allow to soak 3-5  minutes	-	
    Boil mixture  in   suitable container until  dissolved, stirring  to  pre-
      vent burning on bottom  of container	
    Or expose in suitable  container to actively flowing  steam	
    Unless dehydrated or within range, adjust to pH 70  ± O.I .. '.. .
    Use suitable color standards or electrometric equipment 	
    Titrate if necessary, with diluted alkali or acid 		
    Calculate and add NaOH  solution to produce desired pH 	'.. .
    Mix thoroughly, and again test reaction 		
    If incorrect,  further adjust;  if error  excessive, discard batch  	
    If necessary  clarify by centrifugation, sedimentation, or filtration
       so as not to  remove or  add nutritive ingredients  _._	
    If necessary  restore lost weight	_	—	
    Distribute  in suitable containers . _	 >
    Limit amount so no part will be more than 2 5 cm from surface ...
    Use suitable closures and autoclave			
    Prevent contamination  and evaporation during storage 	
    Determine pH  of each sterilization batch of agar before  use ..  .
    Record reaction of medium  (acceptable  range pH  7.0 ±0.1)
 33. a.  Adjustment of reaction — potentiemetrle	
        Allow electrodes to equilibrate at temperature of test  	:.
        Adjust pH  buffer solution to same temperature		).
        Use 45°  C  if  agar undiluted, or provided results are  equiva-
          lent, lower temperature if diluted  1:1  with freshly  (or 1:2
          with  freshly boiled)  distilled water		_	L..
        Maintain required  temperature until  reading is complete
    b. Ad|ustment of reaction — colorimetric   	
        Use 2 clean tubes   (identical with color standard  lubes)  	
        Add suitable amount of distilled water and liquefied agar	.
        Add standard indicator solution to one tuba		
        Using comparator  block, superimpose tubes and standard: . .  .
                                                                             148

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 )EPARTMENT OF  HEALTH, EDUCATION,  AND WELFARE
PUBLIC HEALTH SERVICE
 Survey  Form  for  MiBk  Laboratories
                                                             PHS-I500-J
                                                             (Roy 5-65)
 Indicating conformity with the Pasteurized Milk Ordinance —
 1965  Recommendations of the  United  States  Pnli'ic  Health
 Service
lURVEY BY
.ABORATOKY
X^DhVIATION
LOCATION
0=UNDET£RMIN£D O=NOT USED
DATE
                                                      AGAR  PLATE METHOD
                         DILUTING SAMPLES
  I.  Selecting dilutions	
     Normally  plate two decimal dilutions per sample	
     Select dilutions to yield one  plate with 30-300  colonies  	,
     If single plate of single dilution used routinely,  identify  analyses
       based upon plates outside limits, and		
     Recheck such supplies promptly, using two dilutions	
  2.  Identifying plates 	
     Before malting dilutions, arrange plates in order	
     Identify each with sample number and with dilution to be used . . .
     Record date and plating time  (AM  or  PM)  for  each set of

     If interval between sampling and analyses exceeds  4 hours, record
       bo*h times on reports ._	-	-	
  3.  Sample agitation  	
     Immediately before removal of any portion, thoroughly and vigor-
       ously mix contents of each container	-	
     Invert filled retail containers repeatedly until contents are homo-
       geneous 		._.		
     Before  opening container,  remove  potential  contaminants  from
       c'osuro  . .   ...  „ .. „ ........... ........»..--..._..—....	- —	   • - - •
     Optionally wipe top with sterile, alcohol-saturated cloth	
     Where  practicable, mix wholesale and  process samples  in  con-
       tainers which are not more  than % to % full  	-	
     Immediately  before transferring each tost portion (except  from
       filled containers) share each container 25 times 	
     Each shake e complete up-and-down movement of  about  I foot.. .
     Within  7  seconds  	-	
  4.  Sample measurements  	
     Use sterile pipette for initial  transfers  from each  container	
     Tips not dragged over exposed exteriors of pipettes in case	
     Pipettes not wiped or dragged across lip or neck of container . . .
     Not inserted  more than 05-1" below surface	
     When removing measured portions,  touch off liquid  at tip .(allow
       lower side  of pipette to contact inside of container) 	
     Drainage  apparently complete, excessive liquid  not adhering 	 .
     Add test  portions to dilution  waters  preferably at 15-25° C  .   ...
     Complete each transfer within 2-3  seconds 	
     Let column drain from graduation to apparent rest point in  tip
       (promptly  and gently blow out last  drop) 		
     Male transfers carefully and do not  rinse  pipettes  in  dilution

  5.  Dilution agitation 	-	
     Immediately  before transferring  each test portion  of dilutions,
       shale each container 25 times _.:			-	
     Each shale a complete up-and-down  movement of  about  I foot... .
     Within 7 seconds _			
     Optionally use approved mechanical shaker for proper time 	
6. Dilution measurements 	
   Use a  sterile pipette  for initial  transfers  from ooch successive
     dilution  container 						
   Tips not dragged over exposed exteriors of pipettes in case ..
   Do not wipe or drag pipette across lip or neck  of container .
   Pipette not inserted more than 0.5-1"  below  surface 		
   When removing measured portions, touch off liquid at tip (aNow
     lower side of pipette to contact inside  of container] 		
   Drainage apparently complete, excessive liquid not adhering 	  .
   Measure accurately, make transfers carefully	— —	
   Gently lift cover of petri dish only high enough to insert pipstte  .
   Hold pipette at angle  of 45° with tip touching  inside dish (or in-
     side nect of dilution bottle, or  rod or rubber  stopper] .  	  .
   Allow 2-3 seconds for  diluted  milk or cream to drain from grad-
     uation mark to apparent rest point in tip of pipette	
   Then touch pipette tip once against a  dry spot on glass _	
   In measuring O.I ml, do not similarly  touch dry area	
   Do not prepare, dispense dilutions, or  plate in  direct sunlight 	
7. Cream samples 	
   Using an accurate  balance, preferably weigh  I gm  (or 11 gm)
     aseptically into dilution bottles  or sterile butterboats	
   Preferably use dilution blanks heated to 35-40°  C _	__	
   If necessary to measure portions with  11-ml pipettes,  predeter-
     mine ability to deliver exactly II ml  of cream		
   When making dilution, let column drain to apparent rest point in
     tip and promptly blow out last drop				

                             PLATING
8. Plating	_	
   Melt ogor quietly in boiling water, or expose to flowing  steam 	
   Avoid prolonged exposure to high temperatures during and after
     melting  (do not melt more than will  be used  within 3 hours] ...  .
   Promptly cool melted  ogor to about 45° C, and store  until used
     at 44.46° C			
   For temperature control of medium, insert thermometer in sepa-
     rate pilot bottle  (containing water) of lypo used for egar	
   Expose blank to same melting and cooling condition used for agar  .
   Select  number of samples in any  series so that  all will  be plated
     within 20  minutes after diluting first sample —	-	
   After depositing tost  portions, promptly introduce 10-12  ml  of
     liquefied (not lumpy)  medium  at 44-46° C into each plate	
   Gently lift cover of potri dish only high  enough to pour medium  .
   Flame  lips  of  media  containers  immediately before  (except
     screw-cap bottles) and periodically  during pouring  (and whon
     completed, if portions remaining are to be used later) 	.
   Agar and test  portions thoroughly mixed, by rotating and tilting
     without splashing, and mixture  spread  evenly 		_	
   Allow to solidify within 5-10 minutes on level surface ._	
   Invert (unless clay tops are used) and promptly Incubate	  ...
                                                                       149

-------
                              CONTROLS
 ». Sterility control*	-	
    Check sterility by pouring control plates  for each sterilization lot
      of dilution blanks and medium used		—	
    Pour control plates for each series of samples			
    Whore control tests have shown contamination, wipe plating area
      with damp towel immediately before plating _	

                             INCUBATION
10. Incubation 	
    Remove plates from  containers (unless  these  permit plates  to
      reach incubation temperature within 2 hours) 	
    Arrange so each  plate or pile  is separated by at least  I" from
      adjacent piles,  and from top and walls of chamber	
    Place piles directly over each other on successive shelves	
    Incubate for 48 ± 3 hours, at 32° C	
    Incubate plates in suitable places only 	
    Determine temperatures by not less than  two thermometers (I on
      top and I on bottom shelf, and in between as needed)  	
    Thermometer bulbs submerged  in  water  or other liquids,  within
      small, tightly closed vials or flasks 		
    Optionally use automatic devices of predetermined  accuracy for
      controlling and  recording  temperatures  (periodically  supple-
      ment with readings from standard thermometers)  	
    Unless recording thermometers are  in continuous operation, pref-
      erably install maximal and minimal registering thermometers to
      indicate gross  temperature deviations  (do not depend  upon
      such readings for daily records) 	
    Preferably keep daily records of temperatures (early AM end late
     »PM) in  areas  used,  especially where temperatures are apt to
      vary or where records may be required  for court testimony	
    To reduce spreader formation, avoid excessive humidity .    	
    To prevent excessive drying, control ventilation and air circulation
      (agar should not lose more than  15%  weight in 48 hr)	

                       COUNTING COLONIES
11. Counting aids	
    Count colonies with aid of magnification  under uniform and prop-
      erly  controlled  artificial  illumination (equivalent  to dark-field
      Quebec colony counter) 		
    Routinely use guide plates ruled in  square centimeters	
    Mechanically record total colonies with a hand tally 	
    Avoid mistaking  particles of  undissolved  medium or precipitated
      matter in  plates for pin-point colonies 	_	
    To distinguish colonies from foreign  matter, examine  doubtful
      objects carefully, using higher magnification where  required — .
'2. Selecting and counting plates	-	
    After incubating plates for 48 ± 3  hours, promptly  count all col-
      onies on selected plates  	
    Where impossible  to count at once, store  plates at about 5° C
      for not  more than 24 hours,  but avoid this routinely 	
    Normally select  spreader-free plates with  30-300  colonies and
      count all colonies  including those of pin-point size 	— •
    If  consecutive dilutions yield 30-300  colonies,  report arithmetic
      average (unless higher computed count is more than twice the
      lower, in which case report the lower  computed  count)  	
    If  spreaders occur on  plates selected, count colonies on  repre-
      sentative portion only when colonies are well distributed, and
      when area covered or repressed does not exceed '/j of plate — .
    If no 30-300 plates, use plate over 300 having nearest 300 colonies .
    If plates from all dilutions yield less than 30 colonies each, record
      actual  number  on lowest dilution,  but  report count  as  "less
      than" 30 times  corresponding dilution  			
    If all plates from  any samp'e  show no colonies, have excessive
      spreader growth, are known to be  contaminated, or otherwise
      unsatisfactory, report  as "No colonies"  (NC),  "Spreaders"
      (Spr),  "Laboratory accident" (LA), or "Growth inhibitors" (Gl) .
    If only one of duplicate platos yields  30-300 colonies, count both
      (unless otherwise excluded), and  average		_	 .
    Where one or  more  duplicates  from consecutive  dilutions ore
      counted, compute average count  per dilution before determin-
      ing if higher computed count is more than  twice the lower one
13. Estimating counts 	_	 ,
    Where colonies per plate appreciably exceed 300, count colonies
      in  portions representative of distribution and estimate total	
    Where less than 10 colonies per sq cm, count 12-14 areas, select-
      ing,  if representative, 6 or  7  consecutive squares  diagonally
      across  plate and  6 or 7 consecutive squares at right angles 	
    Where over 10 per sq cm, count 4 representative areas  	
    Multiply  average  number per sq  cm by appropriate factor 	
    Avoid reporting counts as TNTC  _	-	
14. Counting spreaders  	 .
    When spreaders must  be counted, count each as single colony _. .
    Count  chains from  separate sources as separate colonies 	
    If 5  percent  of plates are more  than '/) covered by spreaders,
      take immediate steps to  eliminate this trouble 	_	
15. Personal errors	
    Avoid inaccurate counting  due to carelessness or impaired vision
    Periodic eye examination if eye distress or if counts differ		.
    Discover  cause and correct if unable to duplicate own counts on
      same plate within 5  percent			,
    And  counts of other analysts within  10 percent		 ,

                               REPORTS
16. Recording counts  	
    Record dilutions used 	_	_
    And  number of colonies on each  plate counted	—.-	_		
    Record results of sterility control tests  on materials ._	_	
    Correctly multiply number  of colonies (or average or estimated
      number) per  plate by the reciprocal of the dilution used ..	
    Record only first two left-hand digits,  raising second digit to next
      higher  number when  third digit is 5 or more		 ,
    Record as "Standard Plate  Count" SPC/ml, or SPC/g
    Record incubation  temperature used			
    Report estimated counts made according to directions  as SPC ..  ,
    When  estimates are not obtained according to standard  pro-
      cedures,  use appropriate terminology in  lieu of "Standard" _.. .

                           MISCELLANEOUS
17. Recommended laboratory  practices...  		_	_
    Personnel adequately trained or supervised 		
    Copy of  Standard  Methods (llth ed) available in laboratory 	
    Floors clean,  walls and  ceilings smooth
    Doors and windows screened, or insects and rodents absent.
    Space adequate, free  from confusion  _	.	..._	
    Used for laboratory purposes only  ....
    Table space, storage, and utilities adequate
    Cabinets, shelves,  and equipment  neat, clean, and orderly ....
    Clean outer garments worn _	
    Clothing  stored outside laboratory or  in closet —
                                                                        150

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HEW, PHS, CENTER FOR DISEASE CONTROL
                 151

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                                      DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
                                                    PUBLIC HEALTH SERVICE
                                                 CENTER FOR DISEASE CONTROL
                                                       Bureau of Laboratories
                                                       Atlanta, Georgia 30333
       APPLICATION FOR LICENSURE  UNDER CLINICAL LABORATORIES IMPROVEMENT ACT OF  1967
                                               PART 1 - GENERAL INFORMATION
  .JAME OF LABORATORY.
                                                     2. TELEPHONE NUMBER:
                                                       (include area code)
  ADDRESS-     Street No.
                                                        City
                                                                                      State
                                                                                                                        Zip Code
  
-------
                                       DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
                                                    PUBLIC HEALTH SERVICE
                                     HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION
                                                 CENTER FOR DISEASE CONTROL
                                                         Laboratory Division
                                                       Atlanta, Georgia 30333
        APPLICATION FOR LICENSURE UNDER CLINICAL LABORATORIES IMPROVEMENT ACT OF 1967
                        (To be completed by and reflect qualifications of person whose name appears in Block 1)
PART II-A - PERSONNEL - DIRECTOR
Date:
l.Name: Last First Minnie nmiai

2. Social Security No.:
Title 20. Chapter III. Section 405.1312. paragraph (b). subparagraph.
                                          CD 121 (..o    CD n> to     a o> d.i     CD w <•> a   CD w <.> b   CD w <•> c
a (2)
                                CD <2> (..i
  Have you qualified to direct a laboratory or serve as technical supervisor through the Public Health Service-sponsored examination for laboratory directors?
  CD Yes     CD No
  If "Yes", indicate in which of the following a satisfactory grade has been achieved
             Specialty Sections: IZH Microbiology           C-1 Serology
                             CD Blood Grouping and Rh Typing
                                                     CD  General Section
                                                        CD Clinical Chemistry
                                                                                                         CD Hematology
  Check those CATEGORIES and Subcategor.es for which you consider yourself qualified as a TECHNICAL SUPERVISOR. Refer to Section 405.1314.
  CD MICROBIOLOGY AND SEROLOGY
        I  I  Bacteriology
        I  I  Mycology
        CD  Parasitology
        CD  Virology
        CD  Serology (Syphilis)
        CD  Serology (non-Syphilis)
                         CD CLINICAL CHEMISTRY
                               I  I Blood and Cerebrospmal Fluid Chemistry
                               I  I Endocrinology
                               I  I Toxicology
                               CD Urmalysis
                         CD IMMUNOHEMATOLOGY
                               I  I ABO Group and Rh Type only
                                                                                            CD HEMATOLOGY (including Hemoglobin)

                                                                                            CD PATHOLOGY
                                                                                                  I  I Exfoliative Cytology
                                                                                                  I  I Histopathology
                                                                                                  I  I Oral Pathology

                                                                                            CU RADIOBIOASSAY
6  How many hours per week do you spend on site in the technical and scientific direction of this laboratory?
  Is there an associate, qualified as a director, who serves this laboratory as assistant director'     CD Yes    CD No
                                                                                               List below.

Name of Laboratory



Is there an associate, qualified as director,
who serves as assistant director'
CD Yes
CD Yes
CD Yes
CD No
CD No
CD No
Address of Laboratory

-

 9. Are you readily available for personal or telephone consultation'  CD Yes    CD No
0 EDUCATION
Name and Location of College or University





Major





Attended
From




To


•


Degree




 :or administrative use only. Do not complete this space.
         Reviewer.
                                                 Date
                                                                           Remarks
. HSM 3.602-2 (COC) PAGE 1 OF 4 PAGES
                                                153.

-------
                                             DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE
                                                           PUBLIC HEALTH SERVICE
                                                       CENTER FOR DISEASE CONTROL
                                                             Bureau of Laboratories
                                                             Atlanta, Georgia 30333
        APPLICATION FOR LICENSURE UNDER CLINICAL LABORATORIES IMPROVEMENT ACT OF 1967
                        (To be completed by and reflect qualifications of person whose name appears in Block J)
PART II-B - PERSONNEL - SUPERVISOR
n»te:
1. Name: Last First Middle Initial
2. Social Security No.:
3. Do you consider yourself qualified to serve as general supervisor in the laboratory'  CD Yes     CD No
  If "Yes"  The qualifications to supervise a laboratory are met by the standards prescribed in the Code of Federal Regulations, Title 20, Chapter III,
  Section 405 1313, paragraph (b), subparagraph (check one):
        CD(1)      CD (2)      CD (3)     CD (4)     CD (4)11)     CD (4) (2)      CD (4) (3)     CD (4X4)
  Check those CATEGORIES and Subcategories for which you consider yourself qualified as a technical supervisor Refer to Section 405.1314
                                                                                  CD HEMATOLOGY (including Hemoglobin)
CD MICROBIOLOGY AND SEROLOGY
   I I Bacteriology
   I I Mycology
   I I Parasitology
   I I Virology
   l~l Serology (syphilis)
   I I Serology (non-syphilis)
CD CLINICAL CHEMISTRY
   I  I Blood Cerebrospmal Fluid
         Chemistry
   CD Endocrinology
   CD Toxicology
   CD Urmalysis
CD IMMUNOHEMATOLOGY
   I  I ABO Group and Rh Type only
                                                                                   CD PATHOLOGY
                                                                                      I  I Exfoliative Cytology
                                                                                      I  I Histopathology
                                                                                      CD Oral Pathology

                                                                                   CDRADIOBIOASSAY
  Are you on the laboratory premises during all hous in which tests are routinely performed7    CD Yes     CD No

  If "No", attach a schedule of supervisory assignments to show that this requirement is met (See 20 CFR 405 1313(a) (1))

  EDUCATION:
Name and Address of College or University

-


Major




Attended
From
(mo., yr )




To
(mo., yr )




Degree




   If you have college credits but no degree, or a bachelor's degree from a foreign or non-accredited United States college or university,
   please enclose a transcript of your college credits.
   LABORATORY TRAINING (attach extra sheets if necessary)
Name and Address of Institution

Laboratory Specialty
in which trained

From
(mo., yr.l

To
(mo., yr.)

Name and Degree of Immediate Supervisor
during Training

  31 administrative use only. Do not complete this space.
 "eviewer
                                                   Date
                                                                             Remarks
  DC 3.602-3 (PAGE 1  OF 4 PAGES)
  EV. 3-74
                                                               154

-------
                                        PART II-B - PERSONNEL - SUPERVISOR (commued)
LABORATORY TRAINING" (continued)
Check one 1 1 Internship 1 1 Residency 1 1 Medical Technology 1 1 Other 1
Name and Address of Institution

Laboratory Specialty
in which trained

From
(mo., yr.)

To
(mo., yr.)

Check one: 1~1 Internship CD Residency 1 1 Medical Technology l~~l Other
Name and Address of Institution

Laboratory Specialty
in which trained

From
(mo., yr )
\
To
(mo., yr )

ffffC'fyl

Name and Degree of Immediate Supervisor
during Training

faftprify)

Name and Degree of Immediate Supervisor
during Training

8. Are you currently licensed to practice:     LD Medicine      CH Osteopathy


  ListState(s)-	___	
0 Dentistry
  and Registration Number(s)'
9. BOARD CERTIFICATION: Are you board certified or board eligible?    ED Yes     d No      If yes, list below
Certifying Authority


Board
Eligible


Date
Certified


Specialization


10. Were you previously employed in     EH A Licensed CLIA Laboratory?     CH A Medicare Laboratory'      If yes. list below:
Name of Laboratory Address
CLIA and/or Medicare Code No? - •••• ...

Name of Laboratory Address
Cl 'A anfVcv IVtedim"? Cod* No*. 	 .....
From
(mo , yr )

From
(mo.,yr)

To
(mo., yr.)

To
(mo.. yr.l

Job Title
Job Title
CDC 3.602-3* (PAGE 2 OF 4 PAGES)
REV. 3-74
                                                                      155

-------
                                 PART II-B PERSONNEL - SUPERVISOR (continued)
1 1 EXPERI ENCE FOLLOWI NG GRADUATION - bachelor's degree- (list most recent first - attach extra sheets if necessary)
Name and Address of Institution


Name and Degree of
Laboratory Director


Employed
From
(mo ,yr )

To
(mo , yr.)

Job Title


Served as Title
From
!mo , yr )

To
(mo., yr.)

Fxpenence was in the following (if more than one. give length of time in each)
1 r*a«a»..i oi.n.*Ai I -»H/\ratAru fnftf cnof iali7pH) 1 1 Clinical Mirm^'O^onv . 1 I Semlnnw 1 1 niinienl ^hpmi^trv


] Pathology
1 ) Radiobmassav ... ......



•
Name and Address of Institution

Name and Degree of
Laboratory Director

Employed
From
(mo , yr 1

cpenence was in the following, (if more than one. give length of time in each)
~| General Clinical Laboratory (not specialized) | ~j Clinical Microbiology . . .. _. {_
r~J ImmunohpmaTology 1 1 Hema^'oQy C

To
(mo., yr )

U Serology
H Pathologi
Job Title

Served as Title
From
(mo., yr.)

To
(mo., yr.)


f \ 1 Radiob'«=>«!
-------
                                     PART II-B - PERSONNEL - SUPERVISOR (continued)
                   ATTENTION: READ THE FOLLOWING CAREFULLY BEFORE SIGNING THIS APPLICATION


Statements or Entries Generally: Whoever, in any matter within the jurisdiction of any department or agency of the United States knowingly
and willfully falsifies, conceals or covers up  by  any trick, scheme, or device a material fact, or makes any false, fictitious or fraudulent state
                         A.                                                                        •"*
ments or representations, or makes or  uses any false writing or document knowing the same to contain any false, fictitious or fraudulen
statement or entry, shall be fined not more than $10,000 or imprisoned not more than five years, or both. (U.S. Code, Title 18, Sec. 1001)
CERTIFICATION: I CERTIFY that all of the statements made in this application are true, complete, and correct to the best of my knowledgi
and belief and are made in good faith.
12. Signature of applicant (sign in mief      	.	,	Date.
       (name in Block II
CERTIFICATION: I have viewed the entries made herein and to the best of my knowledge they are true, complete and correct.
 13 Signature of Current Laboratory
   Director (sign in ink)	Date ,
 CDC 3.602-3 (PAGE 4 OF 4 PAGES)
 REV. 3-74

-------
                                         DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE
                                                     • PUBLIC HEALTH SERVICE
                                                   CENTER FOR DISEASE CONTROL
                                                        Bureau of Laboratories
                                                        Atlanta. Georgia 30333
                                                        .
         APPLICATION FOR LICENSURE UNDER CLINICAL LABORATORIES IMPROVEMENT ACT OF 1967
                 '--,..   (To be completed by and reflect qualifications of person whose name appears in Block 1)
PARTII-C-
1. Date: . .

PERSONNEL - TECHNOLOGIST CD
Last
CYTOTECHNOLOGIST CD
TECHNICIAN CD
First Middle Initial
2. Social Security No.:
3. Do you consider yourself qualified to serve as a Technologist or Technician by the standards prescribed m the Code of Federal Regulations. Title 20, Chapter III.
  Section 405.1315?  \ - CD Yes  -'?-. CD No   '   If yes, by which subparagraph? (check one)
  Technologist- CD (bid)   CD (b) (2)   CD (b) (3) -/-CD (b) (4) (i)   CD lb)(5)      Technician-  CD (d) (1)  CD (d) (2)    CD (d) 13)    CD (d) (4)
3a. Do you consider yourself qualified to serve as a Cytotechnologist under CLIA - 1967 Regulations, Section 74.31 (J>?    l~~l Yes  l~l NO
   If yes, by which paragraph? (check oner*.'••£   D (1)  '   d (2)     D (3)	
   Check those CATEGORIES and Subcategones m which the individual performs tests and give the name of immediate supervisor if the test is performed under
  direct supervision:
                                 i Name of Supervisor
                          Name of Supervisor
                                                                                                                     Name of Supervisor
 ; .CD MICROBIOLOGY1 AND SEROLOGY.
        CD Bacteriology __:	
       • CD Mycology
CD CLINICAL CHEMISTRY
        r—i _  . •-.'•';-/ v ,
       ( I—I Parasitplogy	
       ' CD Virology	1
        CD Serology .(syphilis)	
        D Serology (non-syphilis) <£-
     CD Blood and Cerebrospinal
     ,   ••  Fluid Chemistry	
         '  >f
     LJ Endocrinology	1__
     L_] Toxicology	
     CD Urmalysis 	
. CD HEMATOLOGY (including
       Hemoglobin)	
 CD PATHOLOGY	
       CD Exfoliative Cytology.
       CD Histopathology	
       CD Oral Pathology	
                                                  CDIMMUNOHEMATOLOGY
                                            CD RADIOBIOASSAY
  Do you have a current license as a climcaUaboratory technologist CD     Cytotechnologist
   '       •  "  •^tf..>         ^ •iii'i      .*;'
  LJ»Ye*  LJ No-'" License Mr. ^ •• •  •'	' T      List National Remsrrv	'
                                                    List National Registry.
                             CD     technician CD  issued by the State'
                                             —	Registry No. _
  EDUCATION
  Name and Address of High School:
                                                                                                       Graduated 19
&.Nam» and Address of College or University .•
.•Jv1?*'1 ' ' ' ' ' '


...^ , „ .,. , ....
Major



Attended
From



To



Degree


';
   If you have college credits but no degree, or a bachelor's degree from a foreign or non-accredited United States college or university.
   please enclose-a-transcript of your college credits.
   LABOR ATORY-TRAINING (anach extra sheets if necessary)
  Check one*• CD Medical Technology      CD Cytotechnology   CD Other (specify) _	'—.
Name- and Address of Institution- '
t :
i
Laboratory Specialty in which trained
3
I.-..- ;-.' From
&' (mo., yr.) -
f •
To
(mo., yr.)
." .
Name and Degree of Immediate Supervisor during training
•
Name and Address of Institution , .'.

Laboratory Specialty in which trained
, '•
' % From
"• (mo., yr)
t
To
(mo . yr )

Name and Degree of Immediate Supervisor during training

 For administrative use only. Do not complete this space.
  ieviewer
                                                    , Date
                                                                                   Remarks
CDC 3.602-4 Paaa 1 of 3 Panes

-------
                 PART II-C - PERSONNEL - TECHNOLOGIST. CYTOTECHNOLOGIST, OR TECHNICIAN  (continued)
. LABORATORY EXPERIENCE FOLLOWING GRADUATION flat most recent first - attach extra sheets if necessary)
Name and Address of Institution

Name and Degree of Immediate Supervisor

Employed
From
(mo., yr.)

To
(mo ,yr.I

                                                                                                           (mo., yr.)
                                                         (mo., yr.)
  You performed the duties of a clinical laboratory technologist CD      cytotechnologist CD      technician CD   from.
                                                .to.
  Experience was in the following:  lit more than one, give length of time in each)
        CD Bacteriology.
        CD Mycology	
        CD Parasitology .
        CD Virology.
CD Blood and Cerebrospmal Fluid Chemistry
CD Endocrinology	
CD Toxicology 	
CD Unnalysis 	
        CD Serology (syphilis) '.	
        O Serology (non-syphilis> ,*
        CD Immunohematology   '
        CD Hematology (including Hemoglobin).
CU Exfoliative Cytology.
CD Histopaihology 	
CD Oral Pathology	
CZ] Radiobioassay	
Name and Address of Institution

Name and Degree of Immediate Supervisor

Employed
From
Imo . Yr.)

To
(mo . yr.)

                                                                                                             (mo , yr.)
                                                         (mo . yr )
  You performed the duties of a clinical laboratory technologist O   J' cytotechnologist CD      technician CD   from.
  Experience was in the following:, (if more than one, give length of time in each)
                                                 -to ,
        CD Bacteriology.
        CD Mycology	
        CD Parasitology.
        CD Virology	
CD Blood and Cerebrospmal Fluid Chemistry
CD Endocrinology	
CD Toxicology	
CD Unnalysis	
        CD Serology (syphilis)	
        CD Serology (non-syphilis) _
        CD Immunohematology^——
        CD Hematology (including Hemoglobin).
CD Exfoliative Cytology.
CD Histopathology	
CD Oral Pathology	
CD Radiobioassay	
Name and Address of Institution . v
C
Name and Degree of Immediate Supervjsor

Employed
From
(mo..yr.)

To
(mo., yr.)

                                                                                                            |mo..yr)
                                                        (mo , yr)
   You performed the duties of a clinical laboratory technologist CD .    cytotechnologist O      technician CD  from.
                                                                                                                     .to.
   Experience was in the following:  (if more than one, give length of time in each)
                                                                             ,i
         CD Bacteriology.
         CD Mycology	
         CD Parasitology_
         I  I Virology	
 CD Blood and Cerebrospinal Fluid Chemistry.
 I  I Endocrinology	
 I  I Toxicology	
 I  I Urinalysis	
         I  I Serology (syphilis)	
         I  I Serology (non-syphilis).
         I  I Immunohematology	
         CD'Hematology (including Hemoglobin).
 I  I Exfoliative Cytology .
 I  I Histopathology 	
 CD Oral Pathology	
 I  I Radiobioassay	
:OC 3.602-4 Page 2 of 3 Pages
10-73
   15ft

-------
              ,  PART II-C - PERSONNEL - TECHNOLOGIST, CYTOTECHNOLOGIST. OR TECHNICIAN (continued)

                  ATTENTION:' READ THE FOLLOWING CAREFULLY BEFORE SIGNING THIS APPLICATION

"'itements or Entries Generally: Whoever, in any matter within the jurisdiction of any department or agency of the United States knowingly
  d willfully falsifies, conceals or covers up by any trick, scheme, or device a material fact, or makes any false, fictitious or fraudulent state-
ments or representations, or makes or uses any false writing or document knowing the same to contain any false,  fictitious or fraudulent
  tements or entry, shall be fined not more than $10,000 or imprisoned not more than five years, or both. (U.S. Code,Title 18, Sec. 1001).
  •RTIFICATION: I CERTIFY that all of the statements made in this application are true, complete, and correct to the best of my knowledge
  d belief and are made in good faith.
  Signature of applicant (sign in inkl^	:U	::	Date.
      (Name in Block tl       '-'''"
CERTIFICATION: I have reviewed the entries made herein and to the best or my Knowledge they are true, complete and correct.
10. Signature of Current Laboratory
   Director himin inlel              	                  Date
           .  » K..M!
        12-4 Page 3 of 3 Pages
                                                               160

-------
                                   EXAMINATION SUMMARY
                                                        Code:
   >oratory:
Examiner(s)
Date:
                                                        Arrival
                                                        Departure_
  rector(s)
Hours of Operation Fr
Day	
                                                                                    To
                                                                          Night
  pe of Examination:  F] Original  Q Annual  \^\ Re-examination  Q Expansion  Q Other
Requested:    A123456B1234  C  D  EI   2  3  F   Multiple Sites:  Yes Q
                                                                                   NO  ro
                                                                                         i
                                                                  Examined:
Expansion
Withdrawal
































                                                                                    No
 -Commendations:  License Q Continue Licensure Q Request CAS [  |  Field Conference (  j
.-examine:   Before Licensure
Revoke
                                                 Before Renewal
             Deny
  Eer to Compliance [~|    Date Referred
  NERAL:
                                                                                  No
                                                                              Deficiencies N.A.
BACTERIOLOGY:
 .. JCOLOGY:
                               DD
  •JRASITOLOGY:
                               PD
  [ROLOGY:

 SEROLOGY (Syphilis):
                               DO
                               DD
 CDC 3.608-14 Page 1 of 3
                                                  Ifil

-------
 SEROLOGY (Non-Syphilis)
 ENDOCRINOLOGY:
 TOXICOLOGY:
 URINALYSIS:
  IMMUNOHEMATOLOGY:
  HEMATOLOGY:
  CYTOLOGY:
  CDC" 3.608-14 Page 2 of 3
  7-73
                                                                   Code:	
                                                                                 No
                                                                             Deficiencies  N.A
CHEMISTRY:                                                                             pn   pi
 BLOOD & CSF:                                                                          LJ   L_J
ORAL PATHOLOGY:

               r
                                                162
                                                                                       n  n
                                                                                       n  n
                                                                                     a  a
                                                                                     a   n
                                                                                        n   a
                                                                                      D   a
                                                                                      n   n
  HISTOPATHOLOGY:

                                                                                        D  a

-------
                                                                   Code;      	
                                                                                  No
                                                                              Deficiencies   N.A.
                                                                                       D  D
 ADIOBIOASSAY:
COMMENTS & OBSERVATIONS:
 CDC 3.608-14 Page 3 of 3
 7-73
                                                     163

-------
                            STATE OF NEW YORK*
*  These forms are used in the water  laboratory certification program.
                                    164

-------
 :orm No. FS-1
                           Division of Laboratories and Research
                            Now York Stato Department of Health
             Approved Laboratory Inspection for Chemical Examination of Water
 lame of laboratory^

Location!

 iirectors	
 •ABORATCRY PERSONNELS
County i.
Inspection
DateT
       Qualifications. Degrees
 iENERAL APPEARANCES

     Space:
     Square Feet, approx.s
     Lightings

".QUIPMENTs

  1. (a) Distilled water stills
     (b) Double distilled waters
        •
  2. Demineralizers

  3. Drying ovens

  4. Analytical Balances

  5. Pan balances

  6. Desiccators

  7. Muffle furnaces

  8. pH meter:

  9. B.O.D. incubators

 10. Refrigerators

 11. Turbidimeters

 12. Spectrophotometen

 13. Filter photometers

 14. Pipetss
       Cleanliness:
       (c) NH3-free waters
                                               165

-------
 15. NH3 stilli

 16. Kjeldahl digesters

 17. C.O.D. reflux uniti

 18. Hot piatet

 19. D.O. me ten

 20. Glassware supply)

 21. Conductivity meters

 22. Hpt water baths

 23. Atomic absorptions

 24. Specific ion meters

 25. APHA "Standard Methods'1!

 26. Sample bottless

 27. Steam bath:

'28.-Fume hoodi

 29. ATsine generators

 30. Cyanide stills

 31, Others

JEAGENTS AND SOLUTIONS:

  1. Dry chemicals:
       Quality or grades

  2. Reagents-purchased ox prepareds

  3. Standard solutions-purchased or prepareds

TESTS AND METHODS*

  1. pHi

  2. Alkalinltyt

  3. Hardnesss

  4. Clt

  5. Oxygen consumeds

  6. C.O.D.s

  7c Odori                                        166

-------
  8. Conductivityi



  9. Na



 10. Kt



 11. Asi



 12. Free  NH3



 13. Alb.  NH_
            o


 14...Organic nitrogeni



 15. Nitrites NO i
                2

 16. Nitrites N03»



 17. Colon



 18. Turbidityi



 19. Fei



 20. Mas



 21. Fi


 22. C12 residual



 23. C02


 24. Phenols



 25*. CN:


 26. S04i



 27. PO i
       A

 28. Surfactants*



 29. Bar



 30. Total dissolved  solidst



 31. Cat



.32. Mgt


 33. All


 34. CCEi



 35. Sii



 36. Hgi


 37. Cdi                                         167

-------
 38. Cut

 39. D.O.t

 40. Total Cri

 41. Cr46:

 42. Nit

 43. Pbi

 44. Set

 45. Agt

 46. Zru

 47. Otheri

MISCELLANEOUS:

  1. Result sheet (obtain 1 copy)

  2. Results reported how:

  3. Sample identification:

  4. Laboratory methods notebook:

  5. Standard curves:

  6. General attitude:
   •
  7. Sample preservation - (a) CN~
                           (b) Phenol:
                           (c) Metals:

  8. ARS participant!

  9. Number samples analyzed annually:

REMARKS:
                           Date                Inspecting Chemist:.
                                               Title:.
                                               168

-------
                         STATE OF CONNECTICUT*
*  These forms are used in the water  laboratory certification program.
                                    169

-------
       CONNECTICUT STATS DBPftHTKEMT 0? HEALTH
               LABORATORY DIVISION
              HARTFORD, COSII3CTICUT

APPLICATION FOR APPROVAL AS A LABORATORY DIRECTOR
                                                             ,
(WATER, DAIRY, FOOD, FOOD UTEHSILS)
Part I
1. Last Mane
2. Home Address
street - town
3. Work Address
street town
U. Sex 5. Bate of B
jnonth-da'
First Name l€dole Initial
stats zin t>hona nur-iber
state zit) phona number
irth 6. Citizenship
/-vear £7 USA £7 Other-srscify
7. Education
Naiss of University ; Addr




ess !&.ior Dates Attended Degrees
I
-


NOTE: OFFICIAL COPIES OF PSRTIKEOT ACADEIIIC TRANSCRIPTS MUST ACCOMPANY THIS
APPLICATION 0?. SENT TO THIS OFFICJ1 3Y THE ACADEMIC INSTITUTION. THE
APPLICATION '..'ILL NOT BE PROCESSED UNTIL SUCH TRANSCRIPTS AIC F.EC3I72D
8. Are you currently licensed by the Connecticut State Department of Agriculture
to perform microbiological examinations of dairy products?
/~7 NO £7 1CSS
if yes, give type of license and nu.Tfber
type
number
                        170

-------
                                        PART II
1. Experience: list only those positions i:hich indicate your ability to perform and
     suoervise laboratory vork.  List most recent first; attach extra sheets if
Name and Address of Institution

liane & Address of
Director or supervisor

Your Title

D?.tcs
froi.i

to

 Inscription of duties (be specific)
Hane and Address of Institution

Name & Address of
Director or Supervisor

Your Title

Dates
frm i to


Inscription of Duties
liair.s and Address of Institution

l;a~e & ...caress 01'
Director or supervisor

Your Title

';.- c.es
- J ;-o?! to \i


   Description oi' Duties
Nar.e and Address of Institution

i.ani3 cc Address 01
Director or Supervisor

Your Title

Dates
from

To

    Description of Duties
                                               171

-------
                                PART III
   Type  of  laboratory you wish to direct  (check one or more)
 £7 Milk and dairy products
      Food (microbiological)
      Food (chemical)
                                         £7 Food Utensils
                                        £? Water  (see attached ir.eno  from
                                                Cormissioner of Health)
     Tests you wish to perform in your laboratory:

     /"">' water                                    £17 Cnemical examination of
         /T7 Basic tests of sanitary  significance            food utensils
         r y Heavy metals analysis                    _
         /"-,  Specialised tests on uastevaters  and    £/ Microbiological cr.amina-
         ^     trade wastes                                "tion of foods
 £7 lucre-biological examination of milk
          and dairy products

y"7 Ificrobiological exairination of food
          utensils
                                                         Chordcal exsriirc.iion of
                                                            foods

                                                         Other- specify in detail
     I, the undersigned, do hereby certify that the information provided in this
application is to the best of ry knovledge correct and acc'orate.
                                         Applicant 'n Signature
                                            Date Sig
     Please type or print below the mailing address to which you wish all
     correspondence concerning this spplication ba directed:
                          .  street and number
                         town,  sta-oe, and zip code
                                         172

-------
                             LABORATORY DIVISION1
                   CONNECTICUT STATE DEPARTMENT OF HEALTH
                                  reed
                                  D5r "
                                  Insptd^
                                  Tech Rev
                                                For State Use Only
                                               	  rcg to Corrjn
                                                   reg issued	
                                                   Reg Ko.   "	
  APPLICATION FQS INITIAL RES IS??'.T TOM AND APPROVAL 0? A

 	                     -        Pr.rt I
                                                               O F'/.T.TH LWO?/ T^P.Y
1. Name  of  Prbnnspd j.ahoratonr
 3.  Address of FrorvsM I,.-bnrat?"v

	   rtr.-st                       town
                                                  2.  Date of .". plication
                                                                rtrv
U.  T>-pg of laboratory

     D -Tater

     D Dairy
                                                         statn
                             Food

                             Food utensil
              D Other (spseify)u
        ff O.mershio
     Q Private Individual

     0 Partnership

     n Corarnmant
                                        Cl Corporation  (nonprofit)

                                        D Corporation  (profit?

                                        0 Cther (speeirv)	
   Ovmer^," (enter nrre of" corrara'.ion rr-  ''.j-.'f;  }>r;^ "Mr
      last nsure
                        first
T.1
      lait narre
                        fi^st  nar»
HI
adrlress
•8.
           nnr.a
                        first  r--~
-------
Initial Registration arid £rrroval of a.  I-Vbl ic Health Lab
  5iLr'£lV-'I£ 5lLJXTJC2;TiLL^J]lL^j?iri (directors  roust be approved as  qualified by the
    ri^-'---.r"rf;nt _o*'__h?.-Qth jrri.c-'r r." the fil"ingf of this application)	
  10. U-rr.cV.r

                   .        firpt r-ur;      JT      desrrefis        address
  "IT   f*r\ "^ i >i A t* ^ f*-v*                                                   —~


                                 D^r«     ITT       decrees        address
                         "•.tori'
     last n--"^             first nare     IS       df>»rees        address
     Describe the t-xp3ric-.ice and training of  the laboratory supervisor:
    Sooclalists (por.icr.v. -1  vrho vj.]l ?.Fs:.=;l the dir&ctor(s) and supervisor  in the
       perforrvmce of  specialised pxaninatdon?)
 13.
                                                            r) of gvacialty
 111.
                                                         S3.f 3V M specialty
 16.
      nti-"»      	d?^.^oq	address	  area(n)  of
   Affi"H:ition3 T.-\+ hf^r  1 ibc^^n-ie<> < "^-^ther i '.tcratory of an-r kind, infcmation
      conc-rnir.r: tiv".  ,^.r_-^tl:>. -rzst fc^ i	lied.  The  following infornation is
      required: nature  '."  nffilifition wi'-'.h olher laboratory, nature of duties,
      tj-B spent at ctrc- -laborn1. -.17,'.  Attach this  inforratioa to this application.
                                          174

-------
Initial Registration and Approval  of a Public Health Lab

                                       Part. III
   Fo'iiprvrrt to be u_se3  (list all eqnS pm^flf tffSt will be present ir,3ds
     23.  St^riliaa
         Equipment
     2U.  Ovens
          H meters
26. Color5 -:«tprs,
    and flMoronetors
                                                27. Auto-.ated Enuipr.-3.it
                                                    Chen.iotiy
                                                20. Othrr  cciuipr.snt (spi
                                           175

-------
•Initial Registration and Approval of A Public Health Laboratory

                                   Part IV
  29. !  1  Basic Sanitary Examinations of Water

          As a minimum, the laboratory nust be able to perform the  following:

         A. Bacteriological examinations by MPN nsthod (IS1 r.3lhod can be  used
            also but lab must have MPJ method capability at all times)

         B. Physical tests (odor, color, turbidity, pH)

         Co Chemical tests (nitrates, nitrites, airmonia nitrogen by direct
            nesslerisation, methylene bins active substances, (detergents),
            chlorides, iron, and manganese)

         Check one or both:

D               Methods cised for abov« -.rill b3 identical to those found in the
               most recent edition of Standard i-'ethods for ths Sxamination of
               Water 3nd Was t a water (AVSiJ

D               Other ip.athods used - ds ceiled methodology rrist be attached to
               this application                             ~"


  3°* Ul  Specialized ExandRatjqns of '•-tsr g.nd_Waste:?5bar

          |~n  Ksaiy T-'stals analyses

                      "Standard Ifeti'ocis"  u&: a.

                  ["]J   Other methods used - attach to appliv-tion **
                                                                         9
               QSpacialiaed excTinations of vaotewator and tradsrastes (BOD, COD,
               etc.)

                      "Standard tethods"  used

                      Other method used - attach to application
                                        176

-------
initial Registration cJid Approval of a. Public Health Lab

   	Part IV, Continued	
   31.Q D^-irv Microbiology

        A. D Direct microscopic bacterial count
        B. Q Ae.ar Plate bacteriril count
        C.    Screaninf- Tests Tor abnornal milk
                 Q Direct nicrescopic leucocyta count
                 Q Direct nicroscopic sor^itjc coll count
                  Q Modified Whiteaids test
                  Q iris cons in rastitis tost
        D.  Q Laboratory pasteurization test
        E.  Q Colifor-' Determination
        F.  Q Phos-haiaso deternination (stats procedure to be
        G.  Q Other
   32.Q Fcr-d
        A. Q Aerobic rl?.te  nount
        B. Q Detection. Md  enumeration  of St \phylccoscus  aureus
        C. Q Coliforas
        D. Q Detection and  identification of  Salmonella and Shigslla
        E. a Other (specify)
  33. d Examination  of Food U

         A.  Q Bacteriological
         B.  n Ch.er.ical
         C.  Q Other  (specify)

-------
Initial Registration and Approval of a Public Health Lab

                                     P-rrt V
  3U.Datethat laboratory facilities will be avialable for inspection by a
       representative of the State Department of Health:

       	   Q definite     QApproximate
                       dvr
  3J>.  Furnish the naruj of the person (either registrant or ciir^tor) *.rho can bo
       reached by the Dapsrtnent to discuss this application and to rcake arrangements
       for inspections and reviews:
       War-                    Title              Address              Fho.-!«
        V.Q, the undersigned, individually and jointlv certify that the information
   that has b?en provided in this --pplicaticn is to the bast of aur knoulcciie and
   belief accurntj? and correct.
        If rc?istration ?.n' apnrovAl of this I'i.br^-.ory is rrs-nt«:i by tha Comics ior.ar
   of Health, wa agree to contjly fully -irf.th all resulations of tha State of Connecti-
   cut and directives purs'oant thereto that r.vr be issued by the Coru-iissiop.or  of
   Health or his representatives.

        Ve fully i.mderst=.rd that the Emission?- r?f Hs^l+.h may at r,rrr tl--> rnv?'
-------
                          STATE  OF  CALIFORNIA1'
*  Forms starting on page 180 apply to the clinical  laboratory licensure
   program.

   Forms starting on page 190 apply to the water laboratory approval  pro-
   gram.
                                  179

-------
                                                      Slate of California
                                                  Department of lltdllh

                              APPLICATION FOR CLINICAL LABORATORY LICENSE
                                        (Chapter 3. Division 2. Business and Professions Code)
INSTRUCTIONS:                                                    SA.VO /'O    Stale of California, Department ol Mejlili
     1'lcate use typewriter or print in ink. Complete  tliis appli-                       ST^Tsi's" **"**
     canon  and  personnel  report  and  return with  S100  fee                           J°\  „. oeon,
         e   .   Y   .   .   r •»•   •    f~    ,*         t-    \                       Sacramento, CA 95807
     (no Ice is  required of District, City, County or State).
1. Name of Laboratory (Exactly as desired on license)


Street Address
City Zip Code Telephone number including
area code

3. Type of Ownership ,
D Individual
Give Name:
Qpartnership
Give Name of One Partner:
(List others in Item 5)

LjCorporJtion
Give Name of President or Hospital Administrator:
(List Hoard of Directors in Item 5)

D District, City. County or State
Give Name of Administrator.
h
Qothrr (Association. Company, etc.)
Give Name of Administrator:

4. Exact Name of Corporation, District, or Association Owning Laboratory Is.
-
6. Laboratory Uircctor(s):
Give First, Middle, and Last Name




-

2. New Laboratory Opening Date mi
U.i tc
Name of Laboratory Changed on _ __
Date
Date
Director of Laboratory, Channid on . _
Date
Owner of Laboratory Changed on
Date
5 The Name-: of All Other Members of Hirlnfuhip or
Corporation Hoard of Directors Arc.











California Hours/Week Cud= Number
License To Be Spent Mcd. Spec.
Number In Lab (See Over)



-


        / declare under penalty of perjury that the foregoing statements are true and correct, that I have read and understand
     Chapter 3,  Division 2 of the California Business and Professions Code; and Croup 2, Subchapter 1, Chapter 2 of Title 17. of
     the California Administrative Code; and that if a license is granted upon this application, the laboratory regulated by it will be
     conducted in accordance with the provisions of the aforementioned laws and regulations. I also certify that my connection
     with the above laboratory is bona fide, as shown; and that no subterfuge or mental reservation exists in connection with this
     application.
 7. CERTIFICATION OF OWNER WHOSE NAME
   IS GIVEN UNDER (3) ABOVE:
8. CERTIFICATION OF A DIRECTOR WHOSE NAME
  IS GIVEN UNDER (6) ABOVE:
                  Signature
                                                   Date
                                                             180
                   Signature                          Date

                              (Rev.  9-1-73)  Form 2U2-202

-------
For use by physician laboratory directors in completing Item 6 on reverse.
   CODING OF AMERICAN MEDICAL SPECIALTY BOARD CERTIFICATION
          CODE
           11
           12
           13
           14
           20
           30
           40
           50
                           MEDICAL SPECIALTIES
Clinical Pathology and Pathologic Anatomy
Clinical Pathologv
Pathologic Anatomy
Other Pathology Specialties
Internal Medicine
Pediatrics
Obstetrics and Gynecology
All Other Medical Specialties
                                 181

-------
                                             State of California
                                        Department of Public Health

            APPLICATION FOR APPROVAL TO PERFORM PREMARITAL AND PRENATAL
                                   SEROLOGIC TESTS FOR SYPHILIS
INSTRUCTIONS: Complete in duplicate.  RETURN ORIGINAL to  Laboratory Field Services, 2151 Berkeley  Way,
                  Berkeley 94704, and keep duplicate copy for your own file. Use INK or TYPEWRITER.
1. Name of Laboratory
2. Address - Street
City Zip
3. Phone No. - Area Code ( )
I FOR DEPARTMENT USE ONLY 1
1 Released by Date 1
1
• Copy to L.A.
4. Check test(s) for
DVDRL Slide
DAutomatcd
Rcagin (ART)
1
1
which approval is requested
DFTA-ABS DRPR (Circle) Card
CZlAutomaied
FTA (AFTA)
         Check items which are in the laboratory and will be used in the performance of the test(s):
5. Reference manual of serologic tests for syphilis
D California DUSPHS Edition:
Year
6. Water bath
thermostatically controlled D 56°C
7. Centrifuge
EH Horizontal head
D Other head (specify)

8. Refrigerator D
9. Serum controls
D Reactive, quantitative D Weak reactive
D Reactive, qualitative D Nonreactive
D Other (specify)
Source:
10. Pipettes (unetched and unbroken) D
11. Microscope
D Eyepiece 10X (VDRL)
(~l T?;ltrrc fFTAW«neeifvl
D Others (specify)

12. Rotator, mechanical
D 100 RPM (RPR) D Fixed speed
D 1 80 RPM (VDRL) D Variable speed
13. Slides
D Flat-bottomed, with ceramic rings (VDRL)
D Plastic Coated cards with 18 mm circle spots (RPR)
D Glass approx. 1 mm thick with etched circles 1 cm
inside diameter (FTA)
D Other (specify)
14. Bottle, round 30 ml., flat bottomed (VDRL)
Stopper: D Class D Other (specify)

-
15. Needles, without bevels, calibrated for test
D VDRL D RPR
16. Automated system
DAFT A DART
Sourer and model (sper'fy)

17. Air supply (AFTA)
D 30-40 psig
18. Magnetic Stirrer (ART)
Micro Stirring Bar
n Length 1/2" x 1/8" diameter
D Length 1/4" x 1/8" diameter
19. Filter paper #402 (ART) D
20. Vacuum pump (ART)
D 15-20 in. Hg. suitable for continuous operation
21. Sample cups (ART)
DO. 5 ml. size - qualitative
D 2.0 ml. size - quantitative
        I  have read the regulations relating to premarital and prenatal serologic tests for syphilis as contained in Title 17,
   Chapter 2 of the California Administrative Code and agree to abide by these regulations. I will participate in a State oper-
   ated or State approved proficiency testing program as prescribed by the State Department of Public Health.
                    Signature of Laboratory Director
                                                  182
 Date

(Rev. 9-1-71) Form 242-200

-------
,_ , , . LAJiUKAKJK.I3UK.VtTK.CrUK.Jl
State of California
1. Name of Laboratory
2. Address 1
'elephone: Code ( ' )
7. Person(s) Interviewed ' a. Director
b. Owner
c. Technologist
d. Bioanalyst
e. Admin. /Manager
Date of Prior Survey . . , , Cert. Class f. 	 . 	 _
10. I. STATE AND LOCAL LAWS (405.131 0)
"• nln Sub- nNot in n01*"*6 », • njj?
12- UCompli- USub.Com- uSince ^ "-"Change
13. ance phance • Last Survey
14 -. - - " • •• • ~
is! (a)Ucensure DMet DNotMet
IS. (b) Licensed Staff DMet ~ DNotMet
17. (c) Fire and Safety • <-' DMet- > DNot Met
19. II. LABORATORY DIRECTOR (405.131 2) ,v .
*?• r-|InSub..*:nN°tin riChange r-iNo
21- UCompli-  '68 + 10 yrs. exp.
Duties UMet
nction $ ._.
d by M.D.
rised by M.D.
t to M.D.
*• # '
chs #
-


UNot Met
#
*
*
£
41
Not Met
Certificates

Yes
-•i
i
>
• i
- : '
-i;i
*v.
^
^;
—7
	

•
. -..
— — '

No
, r
«.
*l
«..,
	


-
««•

N/
• t
•


-------
 127.
 128.
 129.
 130.
 131.
 132.
 133.
 134.
 135.
 136.
 137.
 138.
 139.
 140.
 141.
 142.
 143.
 144.
 145. '
 146.
 147.
 148.
 149.
 150.
 151.' ,
 152. •
 153..
 154.
 155.-
 156.-
157.
158.
159..'
161.
162.
163.
164,
165.
166.
167.
168.,
169.
170.
171.
172.
173.
174.
175.'
176.
1034.1  Aides # 	
1246   Phlebotomises #
1034    LVN #	
                                   "Cert. #__!	
                                    UMet   DNot Met
   (d) Technician Qual.
      (1) HS + 1 yr. Approved School
      (2) HS + 2 yrs. Approved Lab.
      (3) HS + 50 wks. military course
      (4) Performed 5 yrs. pnor to'68
   (e) Personnel Policies      .-DMet   DNot Met
         DWork hrs   . Ofimp. procedures
         DPromotions  DAccid. comp.
         DDir. interview & select employees
      (1) Employee records
         DTraining     D Experience     <
         DOutiej      DDates of employment
      (2) Health  Records
         DP.E.   ,Dx.R.   Dlmm.    Dlllness
      (3) Work Assignment agree with qual.
      (4) Employee orientation  ' •              >

VI. CLINICAL LABORATORY MANAGEMENT 1220
   (a) Laboratory Management  DMet    DNot Met -
      (1] Adequate workbench space         • •*'
     Total Space	Sq. ft.
     (2) Work areas properly arranged
       :  Blood collection area satisfactory
     (3) Properly ventilated  .'.
     (4) Volatile chemicals properly stored
     (5) Proper temp, and humid controls < ••
     (6) Safety  '..  1050(c)
       . Adequate fire extinguishers
        Fire plan posted
        Fume hood where needed.
        Bact. cabinet where needed
           DManometer      D Satisfactory
        Gas tanks chained
       .Other
  (b) Collection of Specs'.'    - DMet   DNot Met
  (c) Sterilization     '       DMet   DNot Met
     Proper sterilized and wrapped synnges
     Disposable sterile syringes only
      Proper disposal  4143
     Contaminated material adeq. disinfected
     (1) Indicator used each cycle
  (d) Examinations & Reports DMet  . DNot Met
     (1) Written request (patient) - -
     (2) Written request (specimen)
     (3) Receive from lab. report only to lab.
                                                          Yes
                                                        No
N/A
 177.
 178.
 179.
 180.
 181.
 182.
 183.
 184.
 185.
 186
 187.
 188.
 189.
 190.
 191.
 192.
 193.
 194.
 195.
 196.
 197.
 198.
 199.
 200.
 201.
 202.
 203.
 204.
 205.
 206.
 207.
 208.
 209.
 210.
 211.
 212.
 213.
 214.
 215.
 216.
 217.
 218.
 219.
 220
 221.
 222.
 223.
224.
 225.
226.
227.
                (e) Specimens - Records        DMet   DNot Me
                   Daily Accession Record
                   Records Kept
                   (1) Specimens identified
                   (2) Patient identified
                   (3) Submitter identified
                   (4) Date collected
                   (5) Date received
                   (6) Condition of specimens
                   (7) Test(s) performed
                   (8) Date performed
                   (9) Results and date reported
                (f) Laboratory Rep. & Record  DMet   DNot Met
                   Promptly sent to physician
                   (1) Lab. director responsible
                   (2) Duplicate retained 2 yrs. or more
                   (3) Acceptable terminology for tissue
                   (4) Report to paaent authorized
                   (5} Compare with normal ranges
                  (6) List of methods available
                  " (7) Referral lab. medicare certified

                           MISCELLANEOUS
               Clinical Laboratory License Posted
               Personnel Licenses Posted
               Licenses Not Photocopied
               Laboratory Serves
                  Directors private practice only
               •   Medicare/Medi-Cal
               Directors name on report  1055
               Name & address on report  1288
               Referred work properly reported  1288
               Adequate training  1035
               Lab. charges disclosed   655.5
               PM - PN reporting satisfactory
                  Serology   1127
                  Du on Rh neg.  1056
                  Reports properly stamped   1057
                  Rubella satisfactory
               Pathology services retained part time
                  Name
               Path. & Cytol not priced
               Discounts not offered
               24 hr. lab. coverage
               Blood supplier
                                                                                                          650
                                                                                                          650
               Guidelines available
                  Supplement available
               Specimens referred to  _
                                                                                                                                       No
                                                                                                                                     N/.
                                                                         184

-------
 State of California
 Department of Health
                                                QUALITY CONTROL SURVEY REPORT
                                                                                                                           l.abur.itury Scrvi
                                                                                                                        7-12 W>ll(Krv. 41-
 1. Name of Laboratory
                                                                                              3. Provider No.
                                                                                                                          4  State I.I). No.
 2 Address
                                                                         Telephone: Code (       )
                                                                                              S  Date of .Survey
                                                              f>. Ity(liutinl)
  7.
  8.
  9.
 10.
 11
 12
 13
 14
 15.
 16.
 17.
 18.
 19.
 20
 21.
 22.
 23.
 24.
 25.
 26.
 27.
 28.
 29.
 30
 31.
 32
 33.
 34.
 35.
 36.
 37.
 38.
 39
 40.
 41.
 42.
 43.
 44.
 45.
 46.
 47.
 48.
 49.
 50.
 51.
 52.
 53.
 54.
 55.
 56,
 57.
 58.
 59.
60.
61.
62.
63.
64.
CLINICAL LABORATORY MANAGEMENT [1050(e)(3)|
  (a) Proicdurc Manuals                       DMet
DNot Met
Chemistry
Hcmatolngy
Micrnbiol.
Immuno.
N S. Serol.



Name








Ret.








Rev.








Inst.








Cont






-

Std.








Coll.








QUALITY CONTROL
 (a) Equipment - Reagents [ 10SO(d)-(e)(2)      DMct
DNot Met
Photometer
Radio Counter
Blood Gas
pH Meter
Refrigerator
Incubator
Heat Block
Water Bath
Pro. Time
Autoclave
Centrifuge
Hcmat. Cenc
Auto. Chem
Auto. Hcmat,
Prev. Maint.
Freq.

















Rec.

















Rep. & Repl.
Rec.









_-.





..
,
Validate
Freq.










Ree.









X

Calibrate
Freq. Rec.


><
><
-
    (5) Reagents and Solutions
         Properly Labelled - Date Rec./Opened
         Properly Stored       •-'
         Parallel Testing     DRec.
  (b) Specimen Stability             DMet   DNot Met
     Specimens Accepted Through Mail
     (1) Collection Procedure In Writing
         Pirient Preparation
         Specimen Identification »"•
         Storage and Preservation of Specimens
     (2) Only Stable Specimens Accepted
  (c) Methodologies 1050(e)(4)-(f)    DiMet   DNot Met
     (1) Chemistry
         E.ich  Method Checked Each Day of Use
         Control Results Stat. Analyzed
           Dcharted     D Graphed
           Out of Control Results Noted
           Available in Chemistry Area
           Action Limits Clc.irly Shown
         Written Plan For Out of Control
         Standard Included Each Day Each Procedure
           Calibration Curve Used
           Checked  Freq	#Stds.	Dated D
                                                       Yes
                                                           No
        N/A
  65.
  66.
  67.
  68.
  69.
  70.
  71.
  72.
  73.
  74.
  75.
  76
  77.
  78.
  79
  80
  81
  82.
  83.
  84
  85.
  86
  87.
  88
  89.
  90.
  91.
  92.
  93
  94.
  95.
  96.
  97.
  98,-,
  99.
 100.
 101.
 102.
 103.
 104.'
 105." •"
 106.
 107.
 108.
 109.
 110.
 111. .
 112.
 113.
 114.
 115.
 116.
 117.
 118.
 119."
120.
121.

 T85~
 (2) Hematulogy - Controls
     Brand
     RBC- Freq  	 Dftcc.
     WBC-Freq  	 DUirc.
     HCT- Freq  	 DKec.
     HCB-Freq.	 DRcc.
     Prothrombm Times in Duplicate
      Normal Control Each Day
      Abnormal Cont.  Freq. 	
                                                                                                               D Limits
                                                                                                               O Limits
                                                                                                               O Limits
                                                                                                               D Limits
 (3) Immuno-hematology (NON HOSPJ
     Antiscra NIH Approved
      AB Cont Cells. Freq. 	
      Rh Cont. Cells. Freq. 	
     D» On All Rh Negs.
      Coombs Control
     P;s Cell Control - Autoagglucmms
 (4) Unnalysis
     Cont. Brand 	
      Chem. Freq.  	
      Physical Freq. 	
 (5) Microbiology
     Scams Checked Daily
     Reagents Checked Each Batch
     Antisera Checked Each Batch
     Prepared Media
      Brand  	
                           Each Batch Preparation Date
                           Dated When Received
                           Sterility Each Batch
                           Growth Characteristics
                          Suscep. Test Method 	
                           Controls Freq  _____^
     Discs With Desiccant
    Parasite References Satisfactory
       DMicro Slides     DAtlas
(6)SeroIogy  (1127)
    Syphilis • Control Each Day
       DR  Dw DN   DTK
       USPHS Manual - Year
                             Slides (Cards) Satisfactory
                             Antigen Bottle Satisfactory
                             Needles Satisfactory
                                DQual.   DQuant
                                Calibrated: Freq.
                                                              DRc
                                                                                                                     DRec.
                                                                                                                     DRcc.
                                                                                                                     DRec.
                                                              DRcc.
                                                              DRec.

                                                              DRec.
                                                              DRcc.
                                                              DRec.
                                        DRec.
                                        DRec.
                                                                                                                    DRe
                                                             DRe
       Rotator Speed Chkd Freq.	
     Non STS Control Each Day
(7) Radiobioassay
    Standards Each Time
    Background Each Time
    Control Each Time
       DLimits  Dchart   DGraph
(8) Cytology
    10% Negatives Reviewed
    All Positive nr Suspicious Smears Reviewed
    All Non CYN Smears Reviewed
    Smears Kept 2 Years
                                       DRec.
                                       DRec.
                                       DRec.
                                                             DRee.
                                                             DRcc.
                                                             DRec.

-------
122.
123.
124.
125
126.
127.
128.
129.
130.
131.
132.
133.
134.
135.
136.
137.
138.
139.
140.
141.
142.
143.
144.
   (9) Histology
       Stains Checked With Pos. Slides
       Slides Kept 2 Yrs
       Blocks Kept 1 Yr
       Tissue In Fix Until Diagnosed

TRANSFUSION SERVICE  (1002(g)-(j)]
 (g)(2) Recording Thermometer
       Recordings Kept One Year
       Second Thermometer
         Immersed In Liquid
        .Temp. Recorded Twice Daily
 (g)(3) Alarm System
         D Audio - ' O Visual
         Temperature Limits  _____
         Monitored 24 Hrs
          By Whom 	
         Brings Immediate Action
         Lajt Tested          ~
       Only Blood Products Stored
       Auxiliary Power Source
 (g)(4) Air Circulating Fan
                                                         Yes
                                                        No
N/A
145.
146.   (g)(5) AADB Standards Followed
147.          Donor Blood Retyped
148.          Donor Blood Retained 7 Days
149.          Blood Inspected Before Transfusion
ISO.          Blood Kequest Forms Satisfactory
151.         Recipient Sample - Labelled At Bedside
152.          DABOType     D Reverse Type
153.            Antisera NIH #	
154             Cells NIH #	
155.            Expiration Dates Satisfactory
156.          Rh (D) Typing Only (Du Not Done)
157.          Test For Autoagglutinins           DRec.
158.          Test For Unexpected Antibodies    DRec.
159.          Recipient Blood Retained 7 Days
160.          Lab Records Show Actual Results
161.       •  View Box Temp. Checked Daily     DRec.
162.          Optimum Centrifuging Time Determined
163.         Major Cross Match Performed
164.          DSaline    DProtein      DCoombs
165.          Coombs Serum NIH #	
166.              Expiration  Date Satisfactory
167.         Minor Cross Match
168.        Blood Not Removed Longer Than 30 Min.
169.        Records of Receipt & Disposition Adequate
                                                                                                                                 Yes
                                                                                                                                No
170.  COMMENTS
                                                                         186

-------
AMERICAN INDUSTRIAL HYGIENE ASSOCIATION
                   187

-------
                               II.  SIM4ARY REPORT
               These questions are intended principally to serve as

               as outline to guide the site visitor (laboratory

               appraiser) in preparing his summary report of the

               site visit.
A.   General Information
                                                                       Y     N    N/A
     1.   On the basis of the laboratory appraisal the questions      (1)   (2)   (3)
          appearing under the subject heading of General Informa-
          tion, pages 2 § 3 of the questionnaire, were answered
          correctly by the laboratory management with the following
          exceptions:                                                 	   	   	

               If any exceptions are noted please explain briefly.

     2.   The laboratory management appears to be competent.          	   	   	

               If no is checked, please explain.

B.   Laboratory Procedures

     3.   The quality control program is well suited to the need
          of the laboratory                                           	   	   	

     4.   Sample handling procedures are adequate to prevent loss
          or deterioration of samples, confusion with other sam-
          ples or undue delays in processing.                         	   	   	

     5.   The written laboratory procedures are being satis-
          factorily handled.                                          	   	

     6.   The laboratory record system is adequate and records
          are well kept.   If not, please specify.                     	   	   	

     7.   The instrument logs are in good shape.  If not, please
          specify in what way they are inadequate.                    	   	   	

C.   Laboratory Facilities

     8.   Laboratory facilities are good.  If not, specify in what
          way they are deficient.                                     	   	   	

     9.   Laboratory safety practices are satisfactory.   If not,
          specify in what respect they are deficient.                  	   	   	

                                        188

-------
D.   Air Sampling Program                                              Y     N    „,.

                                                                       (1)    (2)   (3)
     10.  Sampling methods and procedures are satisfactory.
          If not, specify in what respect they are deficient.         	   	  	

E.   Detector Tubes


     11.  Procedures for use, calibration, maintenance and
          storage are satisfactory.  If not, please specify.          	   	  	


F.   Inorganic Substances

     12.  Analytical procedures are satisfactory.  If not,
          specify in what respect they are inadequate.                	   	

G.   Organic Substances


     13.  Analytical procedures are satisfactory.  If not,
          specify in what respect they are inadequate.                	   	

H.   Physical Measurements

     14.  Methods are acceptable.  If not, specify in what
          way they are deficient.

I.   Radiometric


     15.  Methods are satisfactory.  If not, specify in what
          respect they are deficient.

CONMENTS:
                                        189

-------
             APPLICATION  FOR  APPROVAL  OF  A  WATER  LABORATORY
             (Title  17, Chapter 2, Subchapter 1,  Group 6,  Sections  1174-1184, California Administrative Code)
        Complete and Return to' the California State  Department of Public Health, Sanitation & Radiation Laboratory
                                  2151  Berkeley  lay. Room 23§ Berkeley, California 94704
1. LABORATORY NAME
2. ADDRESS
                                                          City
            Zip Code
County
3. LOCATION
4. OWNERS)
5. LABORATORY
   TELEPHONE
                                                                                            Ana Code   Number   Ext.
6. LABORATORY DIRECTOR
7. SUPERVISOR or person in Immediate charge  - Name
   Education:  Degree(s), Yeap(s), School(s) 	
   Certificates or Licenses heldt
   Experience (relative to water analyses)!
6. TYPE OF LABORATORY
   -O COMMERCIAL - Laboratory performing work on a fee or contract basis for water purveyors or for private individuals.
^,- D NON-COMMERCIAL - Laboratory performing no work on a fee  basis.
9. LABORATORY WORK FOR WHICH APPROVAL IS REQUESTED  (A commercial laboratory may be approved for complete analyses,
     bacteriological, chemical or both.  A non-commercial laboratory may be approved for specified tests or for
     complete analyses.  Procedures are described in the latest edition of Standard Methods for the Examination of
     Water and Wastewater.)
        G Complete BACTERIOLOGICAL
        n Complete CHEMICAL
        Q Other, specify test(s)i
           NOTE:  Before  approval is granted a site visit  will be made to assess  the  adequacy  of the
                 facilities and qualifications of  the  personnel. Satisfactory analysis of reference
                 samples is also required for approval and is a condition of continued approval.
State of California
Department  of Public Health
                                                    Signature of Owner or Representative
                                                        190
                             Date
                             Porn 245-301
                            (Rev. 7-1-70)

-------
                                                 Stata of California - Dopirtnont of Koalth
                                       Sanitation 6 Radiation Inboittlory - Water 1/ibomtory Approvals
N»BM of laboratory
Address (Kail)

Address rSeoplesJ • UPS

Location Directions
Bite of Visit
County
Supervisor

rtorson Interviewed
Tclo phone
By





  Equijcont & Apparatus *(Use Symbols Listed
                         below to indicate)
        DESCRIPTION
(Model if. Trade Naro. etc.)
Housing end Safety























Arsrrra-otrie Tltnlor or Cl com
A.ifllj-tlcal balance
Atonic absorption
HOD CainbiUtT
Chemical Moreen de'vrid acinratus
Coloriirstcr; Spcctrophotancter
Conductivity rstcr
Dissolved oxvren cetcr
Distillation; Daionization
Drying Ovon
Flaio photometer

Gas chrOTTitocranh
Kteldahl anrnratus
Kuffle furraee
nH cotcr
Pol»rofrraph
Soxhlet epcnratvs
Srceific ion electrodes

Turtldi-eter












•





•





























Adoauato floor smco
Adequate bench srace
Exhaust hood
LlffhUrr
Utilities arrnnrTtent
Eyo wash
Fire extinguisher
Fire blanket
Safety shcrfer
Chcm storare
GlaasKBro storage
.



Ip*hoff rnr(»R
Nessler tubes
R**f rir« ra tor
Ktration Set un
Vater tath



laboratory Data:  Reported.
                  Recorded.
laboratory records retained and available for reference
Standard Methods Q  No   D Tfes  	
Othor roferoncea _________^___^__^___
             .  yrs.
    .edition
                                   1   [ Attach samples of work shoots
   v  Item is in vso or gcrvlco is satisfactory         )
   X  Item nlsslng or deviation in service or equipment :  Use these symbols to indicate
   0  Hot applicable                                   )
                                                                        191

-------
Cu
Ka
CN_
Cr_
Ni
Se_
                                            XlkaOlnlty.

                                            llarxlnoas	
                                            TDS_
Conductivity_

Color	

Odor
                                            Silica.
                                            Temperature..

                                            Turbidity	
                                             Chlorophyll.
                                             Iteslicidcs_
                                                                                            BOD
                                                Clares
                                                COD	
                                                                                            CrcasQ.
                                                                                            KBAS
                                                                                            Nitrogen:
Hitrite_
Nitrate,
Organic.
                                                                                            Phosphate_
                                               Solids:
                                                   Settlcablc.
                                                   . Suspended	
                                                   Total	
                                                                                                Volatile.
                                                                                            SoLTide	
                                                                                            Volatile Acids.
                                                                    192

-------
                                          cf California .  nt>wt-nnt of IWic Go-"
                                          Sanitation and llvJiutioa X.-iborntor/ •
                 RETORT  OF  VISIT TO WATER IAHORATORY
                                                                       HAr.Tl'iUC'.OGICAL
Stato of I/iLori-.tory
Address
Suparricor
mS a1 TiST
O Standard He to Count
C] Coliforn O*!M«

.


Choc'i! cn:h if availablo; indicate nu.iiwr i-Jid tyjo tod iiots  ysrlin--.1.  i.:ariu.  (if earn ssaoo racOjd, use re\-orsu.)
      Ireulutor
        Size
      tbanrosotar          O Ko
      TonporaUiro record   O Ko
    Hot Air Storilizins Oren
      Thoraiojetor          I   ! Ko
    Autocle.ro _^^^^_^^_______
                                        Yes .
                                     CD fos
                                     f~1 1'os
  Iborco33tor          II No
  Icoparaturo record    f~1 !!o
Colony Couator or equivalent _
                                     d Yes
n
               Ion I^uipsint
      Balance 	
      Otbor:   specify 	
            Q?
                        A1J) fi\
  Cleaning 	
  SterilizaUou:
                How _
                Sius
                                , Teoporoture
Culture Ksdia
  Distillod valor courca
  Adjusti-ont of Reaction  I  1 JJo   O Ye3
  Madia Stsrilizatioa
    CD  Autoclave at 121»C. for 15 nicutos 	
    D  Arnold
    l~l  I'ftia. rccorej as roon os pres*uro is rsro
                   at-»   j-.i...-.
  Storage toaroraluro totwon O'C. - 1J-C.    j_J Ko
  Tim t?t.-oon collection & analysis roportedj _ | i!o
                        "
  f~l  At upproximtely ?.yC.
  f~l  Pofrigorator toc_-»rature
      D  (Vornilo ixt 35°C. bof ore uso
SXALDUOUUX* CCu:.f
  llodia
    (~1  Tryptono glucose extract ajor
    l~l  Tryptona glucoso yoost e^ar
    [3  llilk l-rotain lydrol/snto ngor
    PI  Bufforod dilution vutor
  loeuVntion
    D  At 35"C. (± 0.5°C.) for »» *2 hrs.
    CD  At 20"C. (i 0.5«C.) for 'ifl *3 lira.
  Ifothod of Ibjorting llato Count 	
                                                            D
                                                            D
                                                                       liupr.rc.lioi1; UUinsils
                                                                u-a i'.ilas
                                                                   "typs of eloyiro
                                                            n
             Ilo'v'vlcs cr Tubas
                 i}7«i 1
      5Via of clcsura _
    ftitri
      Qear,  flat bolioas    I  I i!o
      Glass or porous tops   O So
      Plastic                C3 l-o
    Saulo Bottlos	
      Salvout.
      Cloovxio
                                                                   Caror ucad ou J.-V and r»ck of slcss clcsuro
                                                                   3Xchlorir.--li:T' i -.i^t  in cfrilo bottles	
                                                                 ESST 1C!
                                                        lidia
                                                         r~l  Inctoce Broth
                                                         f~l  laur/1 Crj-yior.a 3roth
                                                         P  Buffered Dilution Vator
                                                        Incubution at __ CC. for _
                                                        Ke=d_ at end of 2V &_'£  hrs.
                                                        Ks'iu.ED i£3i rai cci-iycri:
                                                        Uodiu
                                                         CD  Brilliant  £^»j.'D  lc--.loso bile broth
                                                         (~1  Eocin roth/l-09  blta  tgar
                                                                                                       hrs.
                                                        Incubation tit __ T,  fcr _____ ^
                                                             at end of Cj ."t f--'.   Q hfl lir-..
                                                                                                        Z* & <'(U IttilAKKS
                                                                                                 (llnv. 0-a*-60)  fo.-s
                                                           193

-------
COLLEGE OF AMERICAN PATHOLOGISTS
              194

-------
                  COLLEGE OF  AMERICAN PATHOLOGISTS
               COMMISSION  ON INSPECTION AND ACCREDITATION

                         INSPECTION  CHECKLIST

                                     SECTION  I

                              LABORATORY GENERAL
                                                    CAP—I &A NO:	
Name of Laboratory	QEP No:	
                                                          CLIA No:	
Address	
                                                          Medicare No:	
City	State	Zip_
                                                          AEC No:	
Name of Director	
                                                          AABB No:	
Name of Inspector:	JCAH No:.

                                                          FDA No:_
HOSPITAL  LABORATORIES                                  State No:_

Name of Hospital	
Name of Administrator-
Name of Chief of Staff-
                                   INSTRUCTIONS:

1. This section must be completed for every inspection. All questions must be answered as "yes",
   "no", or not applicable. ("N/A")
2. Questions printed in red will be answered by the laboratory. Questions printed in black will be
   completed by the inspector.
3. Each question is assigned a "phase" category. A phase 0 question is "for information only". A
   phase I question  refers to a minor deficiency. Phase I deficiencies will not prevent accreditation
   but should be corrected if possible. A phase II question refers to a major deficiency and must
   be corrected for  accreditation. As a general rule, a phase II deficiency is one which could af-
   fect test  results,  and  therefore could affect patient care, or could affect the health and safety
   of hospital and laboratory personnel.
4. Certain questions marked phase I* or II* will be a phase I or phase II only for laboratories or de-
   partments accepting specimens in interstate commerce and using CAP accreditation in lieu of
   federal licensure.
                                        195

-------
                     INSTRUCTIONS FOR  INTERSTATE LABORATORIES
  Laboratories accepting any specimens in interstate
commerce must comply with the rules and regulations
promulgated under the CLIA 1967. If less than  100
specimens are received per year in any one category,
the laboratory may apply for exemption from licensure.
If more than 100 specimens are received per year in
any one category, the laboratory must either be licensed
by CDC or accredited  by  the CAP.  Laboratories
which are exempt from licensure  based on CAP ac-
creditation MUST still meet all of the legal require-
ments of  CLIA 1967.

  Certain questions  in the check  list are designated
"II°" and are for interstate laboratories  only. A "no"
or "N/A"  answer for one of these questions represents
a Phase II deficiency for an interstate laboratory  but
may only be a "I" or "O" for a non-interstate laboratory.
False information:

Laboratories using CAP accreditation in lieu of fed-
eral licensure must verify the accuracy of information
given and sign a statement to that affect.  False in-
formation given in the questionnaire, check  list, or in
the reply to  the recommendation (corrective action
statements) is considered to he perjury and is subject
to fine and penalty under federal law.
  Documentation is essential for the following items:
  1) Number of specimens received, per category per
     year.
  2) Subscription and participation in the appropriate
     Survey  program.
  3) Qualification of all supervisory personnel.
  4) Documentation of all quality control activities
     and procedures.
  The original and underlying objectives of both the
Inspection and Accreditation Program and the Clinical
Laboratory Improvement Act is the improvement in
the quality of laboratory services. The legal require-
ments for laboratories involved in interstate commerce
must be met  by the laboratory and by the College, as
far as it is realistically possible to do so. Exceptions to
the letter of the law aic possible, but must be justified
and documented. Conflicts or disputes over regulations
and standards will be considered but flagrant disregard
of the law may result in legal actions by federal authori-
ties. The College will take all possible steps to avoid or
resolve such  conflicts,  but  the primary responsibility
for complying with  the law lies with the laboratory
director.
                               ABBREVIATIONS used in Checklist:
AABB     AMERICAN ASSOCIATION OF BLOOD
             BANKS
AEC       ATOMIC  ENERGY COMMISSION
BSP       BROMSULPHALEIN
CAP       COLLEGE AMERICAN PATHOLOGISTS
CDC       CENTER  FOR  DISEASE CONTROL
CLIA      CLINICAL LABORATORY
             IMPROVEMENT ACT
CSF       CEREBRAL SPINAL  FLUID
CV        COEFFICIENT  OF VARIATION
JCAH      JOINT  COMMISSION ON
             ACCREDITATION OF  HOSPITALS
KOH       POTASSIUM HYDROXIDE
MT(ASCP) MEDICAL TECHNOLOGIST (AMERICAN
             SOCIETY OF CLINICAL
             PATHOLOGISTS)
NBS      NATIONAL BUREAU  OF STANDARDS

OR       OPERATING ROOM

OPD      OUT PATIENT DEPARTMENT

PAS      PERIODIC ACID  SCHIFF

PT       PROTHROMBIN TIME

PIT      PARTIAL THROMBOPLASTIN TIME

PVA      POLYVINYLALCOHOL

QEP      QUALITY  EVALUATION PROGRAM
             (SURVEY)

RBC      RED BLOOD  CELL

SD       STANDARD DEVIATION

WBC      WHITE BLOOD CELL
                                              196

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Extent of services provided by the laboratory:
                                                            PHASE     CIRCLE ONE
        Hematology	0    Yes   No   N/A   1.001

        Chemistry	0    Yes   No   N/A   1.002

        Urinalysis	0    Yes   No   N/A   1.003

        Microbiology	0    Yes   No   N/A   1.004

        Blood Bank	0    Yes   No   N/A   1.005

        Diagnostic immunology and syphilis serology?	0    Yes   No   N/A   1.006

        Nuclear medicine	0    Yes   No   N/A   1.007

        Anatomic pathology	0    Yes   No   N/A   1.008

        Cytology	0    Yes   No   N/A   1.009


Referred specimens:

        Are all referred specimens sent to a laboratory
        which is either accredited  by the College of
        American Pathologists or  licensed under CLIA '67?	II    Yes   No   N/A   1.011

        Is the name of the laboratory actually performing the
        test indicated on the final report?	II    Yes   No   N/A   1.012


Quality Control:

        The Quality Control programs should  be under constant sur-
        veillance by the laboratory supervisor (chief technologist) or
        by the different section or department supervisors, and should
        be reviewed at intervals by the laboratory director.

        Is there a procedure manual for the quality
        control program to define policies, procedures,
        tolerance limits, corrective actions and
        related information?	I!    Yes   No   N/A   1.020

        Are the quality control programs organized to
        permit regular review?	II    Yes   No   N/A   1.021

        Is there evidence of periodic review of the quality
        control programs by the laboratory director?	II    Yes   No   N/A   1.022

        Are all procedure manuals reviewed periodically
        by the laboratory director?	II    Yes   No   N/A   1.023

        Are all changes in procedures written, dated, and
        initialled by the supervisor or laboratory director?	II    Yes   No   N/A   1.024

        Are quality control records retained
        for at least two years?	II    Yes   No   N/A   1.025
                                             197

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  Physical Facilities
          Allocation and arrangement of space. Is sufficient space pro-
          vided for the following? Are related facilities conveniently
          located for optimum communication, work  flow, transporta-
          tion of specimens, supplies and reports?
  Offices for:                             SU™E,NT                    CONVENIENTLY
                                          SPACE?                        LOCATED'
                              PHASE    CIRCLE ONE            PHASE    CIRCLE ONE
  Laboratory  director	I    Yes   No   N/A  1.031    I     Yes  No   N/A  1.032
  Residents (anatomic)	I    Yes   No   N/A  1.033    I     Yes  No   N/A  1.034
 Clerical staff  (anatomic)	I    Yes   No   N/A  1.035    I     Yes  No   N/A  1.036
 Pathologists (clinical)	I    Yes   No   N/A  1.037    I     Yes  No   N/A  1.038
 Residents (clinical)	I     Yes  No   N/A  1.039    I     Yes  No   N/A  1.040
 Chief  Technologist	I     Yes  No   N/A  1.041    I     Yes   No   N/A  1.042
 Section supervisors	I     Yes   No   N/A  1.043    I     Yes   No   N/A  1.044
 Patient Service Function:
 Outpatient waiting room	I     Yes   No   N/A  1.051    I     Yes   No   N/A   1.052
 Outpatient reception area	I     Yes   No   N/A   1.053    I     Yes   No   N/A   1.054
 Area for venipuncture	I     Yes   No   N/A   1.055    I    Yes   No   N/A   1.056
 Lavatories (specimen col lection). I     Yes   No   N/A   1.057    I    Yes   No   N/A   1.058
 Other  functions: .  	I     Yes   No   N/A   1.059    I    Yes   No   N/A   1.060
   (examination, phlebotomy,
   transfusion, bone marrow)
 Administrative and Clerical Function:
 Anatomic (autopsy) pathology.. I    Yes  No   N/A   1.061    I    Yes   No   N/A   1.062
 Surgical pathology	I    Yes  No   N/A   1.063   I    Yes   No   N/A   1.064
 Cytology	I    Yes  No   N/A   1.065   I    Yes   No   N/A   1.066
 Clinical Laboratory (general)  ... I     Yes  No   N/A   1.067    I    Yes   No   N/A   1.068
 Laboratory Personnel Facilities:
 Library	I    Yes  No  N/A   1.071    I     Yes  No  N/A   1.072
Conference room	I    Yes  No   N/A   1.073    I     Yes  No  N/A   1.074
 Personnel  lounge	I    Yes  No   N/A   1.075    I     Yes  No  N/A   1.076
 Personnel  lockers	I    Yes  No   N/A   1.077    I     Yes  No  N/A   1.078
                                            198

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                                        SUFFICIENT                    CONVENIENTLY
                                         SPACE?                        LOCATED?
                             PHASE     CIRCLE ONE            PHASE     CIRCLE ONE
 Personnel lavatories	I     Yes   No   N/A   1.079   I    Yes   No   N/A   1.080
 Drinking fountains	I     Yes   No   N/A   1.081   I    Yes   No   N/A   1.082
 Personnel Policies
         Is there a manual outlining personnel policies?	I*   Yes   No   N/A   1.091
         Are records maintained on all current employees?	I*   Yes   No   N/A   1.092
         Do personnel records include:
         Resume  of training and experience?	I*   Yes   No   N/A   1.093
         Formal certification or license?	I*   Yes   No   N/A   1.094
         References?  	I    Yes   No   N/A   1.095
         Date of employment?	I    Yes   No   N/A   1.096
         Description of duties?	I*   Yes   No   N/A   1.097
         Record of continuing education?	I*   Yes   No   N/A   1.098
         Record of advancement?	I    Yes   No   N/A   1.099
         Health record? 	I    Yes   No   N/A   1.201
         Microbiology: include chest  X-ray	I    Yes   No   N/A   1.202
         Nuclear Medicine: include record of radiation exposure .. I     Yes   No   N/A   1.203
         Periodic  evaluation  of performance?	I     Yes   No   N/A   1.204
         Incident  or disciplinary action record?	I     Yes   No   N/A   1.205
         Are technologists tested for color blindness?	II    Yes   No   N/A   1.208
         *A "NO" answer is a Phase II deficiency for Interstate Laboratories
Communications within the laboratory:
         Are telephones conveniently located?	I     Yes   No   N/A   1.211
         Can calls be transferred easily?	I     Yes   No   N/A   1.212
         Is there an interdepartmental intercom?	I     Yes   No   N/A   1.213
         Does the laboratory have a direct outside line
        for emergency use?	I     Yes   No   N/A   1.214
Inventory and storage of supplies:
         Is there an inventory control system to minimize
        shortages and eliminate emergency requisitions?	I     Yes  No   N/A   1.215
                                            199

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                                                            PHASE     CIRCLE ONE
         Is the main laboratory storage area sufficient?	I     Yes   No   N/A   1.216

         Is the storage area well organized and free of clutter? .... I     Yes   No   N/A   1.217

         Is refrigerated storage adequate?	I     Yes   No   N/A   1.218

         Is the refrigerator storage area checked for
         temperature control?	II    Yes   No   N/A   1.219

         Is deep freeze storage adequate?	I     Yes   No   N/A   1.220

Labeling and dating of supplies:

         Are all reagents (purchased or prepared),
         kits, and biologicals dated on receipt?	II    Yes   No   N/A   1.221

         Are all reagents (purchased or prepared),
         kits, and biologicals dated when prepared,
         opened or  when  placed in service?	II    Yes   No   N/A   1.222

         Are all biological reagents stored  properly
         (refrigerated  if  necessary) prior to being
         placed in service?	II    Yes   No   N/A   1.223

         Are outdated reagents disposed of?	II    Yes   No   N/A   1.224

Bulk storage of flamrnables:

         Are flammable liquids stored in a safety room with
         explosion-proof switches and an automatic fire door,
         or in a fire proof cabinet?	II    Yes   No   N/A   1.231
         NOTE: If the total volume of flammable liquid is greater than 5 gallons,
              a safety cabinet or room must be used. Small quantities may be
              stored on open shelves.

         Are storage areas and/or rooms where  volatile
         solvents are used adequately ventilated?	I     Yes   No   N/A   1.232

         Are safety  cans used for highly volative liquids?	I     Yes   No   N/A   1.233

Environment:

         Is the temperature adequately controlled during
         all seasons?	I     Yes   No   N/A   1.241

         Is the humidity adequately controlled during
         all seasons?	II    Yes   No   N/A   1.242

         Is the noise level acceptable in all areas?	I     Yes   No   N/A   1.243

         Are  noisy  instruments shielded?	I     Yes   No   N/A   1.244

Housekeeping—general:

         Are passage ways free of clutter?	I     Yes   No   N/A   1.250

         Are floors adequately cleaned and maintained?	I     Yes   No   N/A   1.251

                                           200

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                                                           PHASE    CIRCLE ONE
        Are walls and ceilings clean and well maintained?	I    Yes   No   N/A  1.252
        Are bench tops and sinks clean and well maintained? ... .1    Yes   No   N/A  1.253
        Are bench tops free of unnecessary clutter and trash?	1    Yes   No   N/A  1.254
        Is broken glass disposed of in a separate container
        (marked to avoid injury to custodial personnel)?	I    Yes   No   N/A  1.255
        Are contaminated specimens and materials
      -  properly labeled and disposed of?	II   Yes   No   N/A  1.256
Glassware washing:
        Is the glassware washing area convenient to
        work areas serviced?	I    Yes   No   N/A  1.261
        Is sufficient space provided for washing and drying? ... .1    Yes   No   N/A  1.262
        Are utilities  (water, drains, drying ovens or racks)
        adequate?	I    Yes   No   N/A  1.263
        Are there written procedures for handling and
        cleaning of special glassware (cuvets, micopipets)? .... I    Yes   No   N/A  1.264
        Are contaminated items sterilized or disinfected
        prior to washing? (glassware from bacteriology)	I    Yes   No   N/A  1.265
        Inspect recently processed glassware.
        Are water spots present?	I    Yes   No   N/A  1.266
        Are items tested for detergent removal
        (BSP dye, pH paper, other indicator)?	I    Yes   No   N/A  1.267
        Is the supply of purified water (distilled or
        deionized) sufficient for rinsing glassware?	I    Yes   No   N/A  1.268
        Are chipped and scratched items of glassware discarded? . I    Yes   No   N/A  1.269
Fire safety—general:
        Policies and procedures:
        Are procedures and regulations written?	II   Yes   No   N/A  1.271
        Are procedures and regulations posted or readily
        available to  all  personnel?	I    Yes   No   N/A  1.272
        Are evacuation routes diagramed and posted?	I    Yes   No   N/A  1.273
        Are all personnel familiar with safety policies
        and procedures?	I    Yes   No   N/A  1.274
Evacuation procedures:
        Are fire drills held periodically?	I    Yes   No   N/A  1.281
                                            201

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PHASE CIRCLE ONE
Are fire escape routes (fire exits) convenient
to the laboratory? 	 [
Do all rooms in which major hazard exists have
direct access to the hall or second exit for fast exit? 1
Are rooms with major hazards supplied with fire
extinguishers and a fire blanket? 	 1
Have all personnel been instructed in the proper
use of the fire blanket (i.e., to smother clothing
fire AND/ OR to use as a protective cover in
escaping through an area blocked by fire)? 	 1
Is there a fire alarm station in or near the laboratory? .... 1
Is the fire bell or alarm system audible in the laboratory? . 1
Fire fighting procedures and protective measures:
Is smoking prohibited in all areas in which
volatile solvents are in use? 	 1
Is there a safety shower in each high hazard area
(chemistry, histology)? 	 I
Are asbestos gloves available in high hazard areas? 	 1
Is sand or other nonflammable absorbent material
available for control of burning liquids in high
hazard areas? 	 1
Is there at least one properly placed fire
extinguisher in or near each high hazard area? 	 1
Are they of the right type (COz or dry chemical)? 	 1
Have personnel been instructed in the use of
extinguishers? 	 I
Have personnel been instructed not to use water
or soda-acid types of extinguishers on liquid
and/or electrical fires? 	 1

Yes

Yes

Yes



Yes
Yes
Yes


Yes

Yes
Yes


Yes

Yes
Yes

Yes


Yes

No

No

No



No
No
No


No

No
No


No

No
No

No


No

N/A

N/A

N/A



N/A
N/A
N/A


N/A

N/A
N/A


N/A

N/A
N/A

N/A


N/A

1.282

1.283

1.284



1.285
1.236
1.287


1.291

1.292
1.293


1.294

1.295
1.296

1.297


1.298
Toxic and caustic materials—policies and procedures:
         Is an emergency shower convenient to areas where
         caustic materials are used (reagent preparation,
         acid cleaning of glassware and other high risk areas)? ... I     Yes   No  N/A   1.301

Handling of corrosive and  caustic materials:

         Have personnel been instructed in the safe handling
         of corrosive and caustic materials (i.e.,  handle only
         one bottle at a time, use of carts or carriers for
         transporting, use of transfer devices and safety
         procedures)?	I     Yes   No  N/A   1.302

                                            202

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                                                          PHASE    CIRCLE ONE

        Are mechanical pipetting or transfer devices available
        for use with caustic and toxic materials?	I    Yes  No   N/A  1.303

        Are fountain type eye washers available in areas
        where caustic materials are used?	I    Yes  No   N/A  1.304

        Are safety glasses available and are personnel
        required to wear them when handling caustic
        materials (acid cleaning of glassware, reagent
        preparation,  auto analyzers pumping acids under
        pressure)? .,	I    Yes  No   N/A  1.305

        Are acid bottle carriers used for all large containers
        (over 500 ml)?	I    Yes  No   N/A  1.306

        Are all containers of corrosives, acids, and caustic
        materials properly labeled with a warning as to the
        toxic content?	I    Yes  No   N/A  1.307

PURITY OF  WATER

Method of purification:

        Distillation?  	0   Yes  No   N/A  1.311

        Deionization?  	0   Yes  No   N/A  1.312

        Deionization and ultrafiltration?	0   Yes  No   N/A  1.313

        Other?	0   Yes  No   N/A  1.314

Purity checks:

        Is a system in use for checking purity of water?	II    Yes  No  N/A   1.315

        Are procedures written?	II    Yes  No  N/A   1.316

        Are records of checks maintained?	II    Yes  No  N/A   1.317

        Is the resistance greater than 0.1 meg-ohms
        (100,000 ohms) or conductance less than 4 ppm
        expressed as NaCI?	I    Yes  No  N/A   1.321

        Is the pH between 6.0 and 7.0?	I    Yes  No  N/A   1.322

        Are tests for "total hardness" negative?	I    Yes  No  N/A   1.323

        Is sodium less  than 0.1 mg/L?	I    Yes  No  N/A   1.324

        Is ammonia less than 0.1 mg/L (0.2 ppm)?	I    Yes  No  N/A   1.325

        Are cultures and colony counts negative
        (or show minimum growth)?	I    Yes  No  N/A   1.326

                                            203

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Water usage:
                                                           PHASE    CIRCLE ONE
         Is reagent grade water used for preparation of all
         standards,  reagents, and dilutions of samples?
         (For example, specimens run  on flame or atomic
         absorptiori  spectrophotometers, reconstitution of
         lypholyzed materials)  	II    Yes   No   N/A   1.331

         Is reagent grade water used for reconstitution of
         lypholized materials used for  standards,  controls
         and surveys?	II    Yes   No   N/A   1.332


Specimen collection:

         Is the area clean and well maintained?	I     Yes   No   N/A   1.341

         Are disposable needles and lancets used?	I     Yes   No   N/A   1.342

         Are disposable needles destroyed and disposed of
         in a safe manner (separate container, adequately
         marked to avoid injury to custodial personnel)?	I     Yes   No   N/A   1.343

         Are syringes and needles stored (and disposed of)
         in such a manner to be reasonably inaccessible
         to  unauthorized persons? 	I     Yes   No   N/A   1.344

Specimen collection procedures:

         Is there a procedure manual for the proper
         collection and handling of specimens?	II    Yes   No   N/A   1.345

Does it include pertinent information when necessary regarding:

         Preparation of the patient?	I     Yes   No   N/A   1.346

         Type of specimen to be collected?	I     Yes   No   N/A   1.347

         Need for special timing for collection of specimens? ... .1     Yes   No   N/A   1.348

         Need for preservative or anticoagulant?	I     Yes   No   N/A   1.349

         Need for special handling between time of
         collection and time received by the laboratory
         (i.e., refrigeration, immediate  delivery)?	I     Yes   No   N/A   1.350

         Instructions for proper labeling?	I     Yes   No   N/A   1.351

         Need for clinical data (age,  sex, type of test, diagnosis)? . I     Yes   No   N/A   1.352

Distribution  of specimen collection manual:

         Hospital laboratories: Is the specimen collection
         manual distributed to all nursing stations (floors,
         OR, OPD) and other locations  where specimens
         are collected?	II*   Yes   No   N/A   1.353


                                            204

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                                                           PHASE     CIRCLE ONE
         Non-hospital laboratories: Are instructions for the
         proper preparation of patients and collection of
         specimens supplied to all specimen collection areas
         and physician clients?	II*   Yes   No   N/A   1.354
         *0ne must be answered "yes" or it is a Phase II deficiency.
Specimen receipt procedures:
                                                           PHASE     CIRCLE ONE
         Are all specimens received by the department
         recorded in an accession book, day book,
         worksheet, computer, or other comparable record?	II    Yes   No   N/A   1.361
         Are unlabeled or improperly labeled
         specimens rejected?	II    Yes   No   N/A   1.362
         Are specimens from patients with known or
         suspected hepatitis labeled accordingly?	I     Yes   No   N/A   1.363
         Are specimens containing radioactive materials
         labeled accordingly?	I     Yes   No   N/A   1.334
         Are all specimens accompanied by an adequate
         requisition?	II    Yes   No   N/A   1.365
Does the requisition form include:
         Name of patient?	II    Yes   No   N/A   1.37t
         Identifying number (hospital or laboratory number)? .... II    Yes   No   N/A   1.372
         Name of physician or person ordering test?  	II    Yes   No   N/A   1.373
         Type of test to be performed?	II    Yes   No   N/A   1.374
         Time and date of specimen collection?	II    Yes   No   N/A   1.375
         Time and date of receipt by the laboratory?	I     Yes   No   N/A   1.376
         Are there written criteria for rejection  of
         unacceptable specimens?	II    Yes   No   N/A   1.381
Reports of results of laboratory tests:
         Is the report form adequate in regard  to design,
         space and information?	II    Yes   No   N/A   1.391
Does the report form include:
         Name of patient?	II    Yes   No   N/A   1.397.
         Identifying number (hospital or laboratory)?	II    Yes   No   N/A   1.383
         Name of physician ordering the test?	II    Yes   No   N/A   1.394
         Name of test to be performed?	II    Yes   No   N/A   1.395
                                          205

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                                                   PHASE    CIRCLE ONE
Date or time of collection of specimen?	I     Yes  No  N/A   1.396
Date and time of release of report?	I     Yes  No  N/A   1.397
Normal values, indicated when necessary?	I     Yes  No  N/A   1.398
Are results legible?	II    Yes  No  N/A   1.401
Are results reviewed for clerical errors and
authenticated prior to release from the laboratory?	II    Yes  No  N/A   1.402
Are duplicate copies of reports retained by the
laboratory and filed  in a manner to permit easy
retrieval of information if necessary?	II    Yes  No  N/A   1.403
                                    206

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