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.).
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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).
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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.
28
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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.
30
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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
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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.
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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.
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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.
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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
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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.)
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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.
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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:
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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
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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
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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).
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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
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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
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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-
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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.)
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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
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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.
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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.
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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.
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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.
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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.
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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
-------
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
-------
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
-------
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
-------
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.
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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
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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
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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
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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.
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FEDERALLY OPERATED CERTIFICATION PROGRAMS
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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
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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
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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.
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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.
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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
-------
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
-------
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
-------
)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
-------
HEW, PHS, CENTER FOR DISEASE CONTROL
151
-------
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
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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
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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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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
-------
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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