&EPA
United States
Environmental Protection
Agency
Labcert Bulletin
Editor's Notes...
This issue of the Labcert Bulletin highlights
NELAC with articles written by Silky
Labie, the current Chair of the NELAP
Board of Directors, and the Chairs of the On -Site
Assessment Committee and the Quality Systems
Committee. Contents of these articles are entirely
the authors', printed here as information. Articles
about some of the other Committees were featured
in the March, 2001 Labcert Bulletin.
There is also information on new contaminants for
which certification is required, new PT acceptance
criteria for THMs, other Proficiency Testing
requirements, and a list of helpful web sites.
As always, we want to hear from you. If there are
certification topics you would like to see
discussed, please call, write, fax or e-rnail the
editors. There is a form on the last page for you to
use to add your name to our mailing list or to
update your information.
EdGlick 513 569-7939, glick.ed@epa.gov
Patricia Hurr 513 569-7678, hurr.pat@epa.gov
Caroline Madding 513569-7402,
madding.caroline@epa.gov
MAILING ADDRESS:
USEPA MS 140
Technical Support Center
26 W. Martin Luther King Dr.
Cincinnati, OH 45268
FAX NUMBER:
513 569-7191
Confusion Regarding the
"80% Rule"
We have received numerous questions
regarding the "80% Rule" for passing
PT samples. This Rule applies to two
classes of analytes, volatile organic compounds
(VOCs) and the five regulated haloacetic acids
(HAAS).
Realizing that successfully analyzing a PT
sample containing all VOC analytes annually is
difficult, EPA allows the laboratory leeway in the
analysis of the VOC PT samples. Excluding
vinyl chloride, if the laboratory passes 80% of
the VOC analytes, it can be certified for all of the
VOCs. The "80% Rule" for VOCs has recently
been made more difficult to interpret since some
PT providers may include THMs in the same vial
as the VOCs. The "80% Rule" does not apply to
the THMs if they are present in the VOC ampule.
THMs must be acceptably analyzed individually
(see DBF Rule article on p.5) in order to be
certified to perform TTHM analyses.
In the Stage 1 DBF rule, which becomes
effective in January 2002, the "80% Rule"
applies to the HAAS certification requirement.
If four of the five haloacetic acids which
comprise HAAS (80%) are successfully
analyzed, the laboratory may be certified to
perform HAAS analyses.
a rederal requirement to
\JStfr*#a»n* J»S ,sfL _*«», «=%»,*>
e tunregufated VOCs or to
'^vMBi^^*V8t»4w
-------
&EPA
United States
Environmental Protection
Agency
Office of Ground Water and Drinking Water
Cincinnati, OH 45268
EPA-815-N-02-001a
January 2002
PRESORTED STANDARD
POSTAGE & FEES PAID
EPA
PERMIT NO. G-35
Official business
Penalty for Private Use
$300
In This Issue...
/ NELAC 7 Highlights
S More Contaminants Require
Certification
S New PT Acceptance Criteria for
THMs
«/ More on Proficiency Testing
Requirements
S Some Useful Websites
Recycled/Recyclable
Printed with vegetable-based ink on paper that
contains a minimum of 50% post-consumer fiber
and is processed chlorine free.
-------
&EPA
United States
Environmental Protection
Agency
Labcert Bulletin
Editor's Notes...
This issue of the Labcert Bulletin highlights
NELAC with articles written by Silky
Labie, the current Chair of the NELAP
Board of Directors, and the Chairs of the On -Site
Assessment Committee and the Quality Systems
Committee. Contents of these articles are entirely
the authors', printed here as information. Articles
about some of the other Committees were featured
in the March, 2001 Labcert Bulletin.
There is also information on new contaminants for
which certification is required, new PT acceptance
criteria for THMs, other Proficiency Testing
requirements, and a list of helpful web sites.
As always, we want to hear from you. If there are
certification topics you would like to see
discussed, please call, write, fax or e-rnail the
editors. There is a form on the last page for you to
use to add your name to our mailing list or to
update your information.
Ed Click 513 569-7939, glick.ed@epa.gov
Patricia Hurr 513 569-7678, hurr.pat@epa.gov
Caroline Madding 513569-7402,
madding.caroline@epa.gov
MAILING ADDRESS:
USEPA MS 140
Technical Support Center
26 W. Martin Luther King Dr.
Cincinnati, QH 45268
FAX NUMBER:
513 569-7191
Confusion Regarding the
"80% Rule"
We have received numerous questions
regarding the "80% Rule" for passing
PT samples. This Rule applies to two
classes of analytes, volatile organic compounds
(VOCs) and the five regulated haloacetic acids
(HAAS).
Realizing that successfully analyzing a PT
sample containing all VOC analytes annually is
difficult, EPA allows the laboratory leeway in the
analysis of the VOC PT samples. Excluding
vinyl chloride, if the laboratory passes 80% of
the VOC analytes, it can be certified for all of the
VOCs. The "80% Rule" for VOCs has recently
been made more difficult to interpret since some
PT providers may include THMs in the same vial
as the VOCs. The "80% Rule" does not apply to
the THMs if they are present in the VOC ampule.
THMs must be acceptably analyzed individually
(see DBP Rule article on p.5) in order to be
certified to perform TTHM analyses.
In the Stage 1 DBP rule, which becomes
effective in January 2002, the "80% Rule"
applies to the HAAS certification requirement.
If four of the five haloacetic acids which
comprise HAAS (80%) are successfully
analyzed, the laboratory may be certified to
perform HAAS analyses.
irement to
* *, tf - iv **
VOCs or to
~grf yt** ** »* * -*tf*^¥ «-*
analytes. This
" .- ~
e'
^
-------
T
Highlights from NELAC 7
by Silky S. Labie, Chair
NELAC Board of Directors
he weather was mild and sunny, and Salt Lake City was beginning to roll out the Red Carpet for the
Winter Olympics. NELAC 7, hosted by the Utah Department of Health, could not have had a better
setting.
The revisions to the NELAC standards can be roughly categorized as: fixes, clarifications, and major
direction changes.
FIXES: These revisions were designed to "fix"
something in the standard, whether it was to close
loop holes, or help resolve inconsistencies of the
NELAP implementation process: The revisions
1. Provide specific circumstances under which a
technical director can be grandfathered in.
(Chapter 4).
2. Outline the manner in which differing
standard interpretations will be resolved.
(Chapter 6).
3. Provide comprehensive requirements for the
content of general and technical assessor
training courses (Chapter 3).
4. Require that the NELAP assessment team
observe the techniques used by the
Accrediting Authority during an on-site audit.
(Chapter 6).
CLARIFICATIONS: These revisions were made to
clarify or simplify existing standards, with no
significant changes:
1. Refined and simplified Appendix D.I.,
Chemical Quality Controls and Appendix
D.3., Microbiological Quality Controls
(Chapter 5).
MAJORCHANGES IN DIRECTION: These revisions
will have a significant impact on how NELAP is
implemented:
1. Fields of Accreditation were changed from
Program-Method-Analyte to Matrix-Technology
Method-Analyte/Analyte Group (Chapter 1).
2. The Fields of Proficiency Testing were also
changed to reflect to changes in Chapter 1:
matrix-technology-analyte/analyte group
(Chapter 2).
Conferees came to NELAC 7 with questions about
EPA's continuing support. They left with the
knowledge that EPA has negotiated a 5-year
contract at the present level of funding to support
NELAC, and that EPA has applied for recognition
as a NELAP Accrediting Authority.
Further, the conferees found that NELAC was
responsive to the criticisms and anxieties about
inconsistencies among NELAP Accrediting
Authorities by developing standards, and
implementing many proactive programs designed
to minimize their concerns.
A majority of the standard revisions were minor
corrections that did not alter the intent of the
standard. NELAC can finally settle down to focus
on implementation and encouraging more states to
join the NELAC community.
More information on NELAC may be found at the
NELAC website: "http://www.epa.gov/ttn/nelac/".
-------
NELAC Quality Systems
by Scott D. Siders
Illinois EPA, Springfield, IL
Past Chair, NELAC Quality Systems Committee
The National Environmental Laboratory Accreditation Conference (NELAC) at its annual meeting
(NELAC 7) which was held May 22 - 25, 2001 in Salt Lake City, Utah, adopted proposed changes
to the Quality Systems standard. At the Interim Meeting (NELAC 6i) in November 2000 the NELAC
7 Quality Systems Committee:
discussed the efforts to update the Quality
System standard to the new- international
standard (ISO/IEC 17025);
reviewed the Environmental Laboratory
Advisory Board's (ELAB) proposed changes to
the Chemical Testing section;
presented proposed changes for the
Microbiology Testing section; and
reviewed its efforts to draft an Asbestos Testing
Appendix.
A significant new direction was taken based on
ELAB's presentation of a Performance-Based
Measurement System (PBMS) straw model. The
Committee, at the urging of other NELAC
stakeholders, formed a PBMS Subcommittee to
review the PBMS straw model and further
investigate incorporating PBMS into NELAC.
At NELAC 7, there was overwhelming support for
the Quality Systems standard to be consistent with
ISO/IEC 17025 in both content and format. Some
significant additions and/or changes to the standard
would be sections on:
1. Identification of potential conflicts of interest
2. Service to clients
3. Preventive action
4. Corrective action
5. Method validation
6. Measurement uncertainty
7. Document control
8. Requests, tenders and contracts
Further, the proposed revisions to the Quality
Systems standard will include the sections that the
PBMS Subcommittee is modifying. ELAB's PBMS
straw model brought two key concepts to the table:
Method selection; and
Method validation.
To address the PBMS straw model
concepts/elements the following sections of the
model are important areas to revise:
Test methods and standard operating
procedures;
Calibration;
Demonstration of capability; and
Chemical testing.
As a result, the PBMS Subcommittee has essentially
completely rewritten sections of the Quality
Systems standard, which will be discussed at the
next Interim Meeting in December. The Quality
Systems Committee is currently reviewing and
commenting on the PBMS Subcommittee's most
recent proposal. This proposal has, at its core,
language for method selection and validation
including:
a proposed model for initial method validation
based upon representative matrices;
ongoing method validation steps to determine
and document sources of uncertainty relating to
actual samples and system influences.
The PBMS Subcommittee is currently, among other
things, considering whether a "tiered" approach to
method validation should be considered,
differentiating between EP A-mandated methods and
alternative methods.
Again, at NELAC 7 the Quality Systems
Committee's ISO/IEC 17025 integration effort and
the PBMS Subcommittee's efforts were presented
publicly for the first time during a special session,
-------
as these two issues were not put to a vote. A straw
poll revealed broad support for the full integration
of ISO/IEC17025 by allNELAC stakeholders (i.e.,
states, federal agencies, and the private sector).
The Quality Systems Committee included on the
NELAC voting agenda changes to microbiology
testing and ELAB's recommendations on chemical
testing. These proposed changes were adopted with
minor modifications (e.g., Method Blank Criteria).
The final 2001 standards are posted on the NELAC
Homepage website at:
http ://www.epa. gov/ttnnelal /.
NELAC On-site Assessment Committee
C
by Alfredo Sotomayor
On-site Assessment Committee Chair
ertification and inspections, accreditation and on-site assessments, in NELAC parlance, are linked
inextricably. It has been said that an accreditation program is only as good as the laboratory assessments
it delivers. The On-site Assessment Committee is responsible for generating procedures that Accrediting
Authorities (AA) use to perform on-site
assessments. Through Chapter 3, the committee
specifies such essentials as the frequency,
mechanics, and documentation of assessments, and
establishes qualifications for laboratory assessors.
The On-site Assessment Committee is also
responsible for generating and maintaining the
NELAC Quality Systems (Chapter 5) Checklist.
At the last NELAC Annual Meeting (May 2001),
the conference approved for immediate
implementation two appendices in Chapter 3 that
identify the content of training courses for
laboratory assessors. Appendix A specifies the
minimum standards for NELAC Basic Assessor
Training Courses, while Appendix B does the same
for Technical Training Courses. NELAC and the
National Environmental Laboratory Accreditation
Program (NELAP) themselves cannot offer training
courses, but now that the appendices are approved,
providers should start designing and marketing
courses that can be used to meet NELAC training
requirements for assessors.
The On-site Assessment Committee is currently
drafting another appendix that specifies elements
that all AAs will need to address in a Standard
Operating Procedure (SOP) for planning,
conducting, and closing laboratory assessments. We
will present a second draft of this appendix for
discussion at the next interim meeting in December.
We envision that this appendix will give more
specificity to the activities assessors use and the
type and number of records examined to assess a
laboratory's conformance to the NELAC Standards.
EPA has acknowledged that a state can meet the
primacy requirements of the Safe Drinking Water
Act (SOWA) regulations by obtaining NELAP
recognition in the NELAC SDWA tier. As EPA
makes progress in becoming an AA, the Committee
will explore ways of formalizing the equivalency
between SDWA laboratory certification audits and
NELAC laboratory on-site assessments. The
Committee welcomes your comments on Chapter 3,
or any issues related to laboratory on-site
assessments. Use the form posted on the NELAC
website and send it electronically to
sotoma@.dnr.state.wi.us
-------
New Contact for
USEPA Laboratory ID
Numbers
Effective April 1, 2001, Charles Feldmann,
Office of Ground Water and Drinking Water,
Technical Support Center, is the primary
contact for assignment of new laboratory IDs for the
PT studies. He may be reached by phone at 513-
569-7671 or by FAX at 513-569-7191.
1) If the laboratory has ever participated in an
USEPA-run study, the laboratory will already have
a unique ID. Please review any previous "study
results" report to locate the ID number.
2) If a laboratory cannot locate this information, the
laboratory should contact Mr. Feldmann for
assistance.
3) Laboratories must include this information when
reporting PT results.
Certification Changes
On December 1, 1999 EPA published a final
rule often referred to as MUFRN II
(Methods Update Federal Register Notice
II) in the Federal Register (64 FR 67450). In
addition to approving several updated or new
drinking water methods for chemical and
microbiological contaminants, the Rule amended
some laboratory certification requirements.
Specifically, the Rule amended the regulations to
codify some of the provisions in the 1997 Drinking
Water Laboratory Certification Manual. These
amendments include a requirement to demonstrate
proficiency by successful analysis of a PT sample
annually for chemical contaminants using the same
analytical method that is used to report compliance
monitoring results. In order to receive and maintain
certification for an analyte, the laboratory must
successfully analyze PT samples (if available)
acceptable to the EPA or the State at least once per
year for each analyte and by each method used to
analyze compliance samples. This does not include
methods used solely for corifirmation.
Because of this requirement, we are requesting that
Certifying Authorities list on the certification
certificate or a letter attached to the certification
certificate, the methods and each analyte in that
method for which the laboratory is certified.
Certification Alert
Stage 1 DBF Rule
Effective January 2002
The Stage 1 Disinfection By-Product (DBF)
Rule, which was promulgated in December
1998, became effective for large surface
water systems in January 2002 and all laboratories
should be certified by this date to analyze HAAS,
chlorite and bromate.
The Rule lowers the MCL for TTHMs to 0.080
mg/L and sets the MCL for HAAS at 0.060 mg/L.
Haloacetic acid 5 is the sum of the concentrations of
five haloacetic acids (HAAS): monochloroacetic
acid, dichloroacetic acid, trichloroacetic acid,
monobromoacetic acid and dibromoacetic acid. It
also sets MCLs of 0.010 mg/L for bromate and 1.0
mg/L for chlorite.
The Rule requires that laboratories be certified to
perform these analyses for compliance monitoring.
To be certified, the laboratory must annually pass
PT samples for these analytes. The "80% Rule"
applies to the HAAS, so if four of the HAA5 are
successfully analyzed, the laboratory may be
certified for all of the HAAS. A laboratory should
not be certified for an analyte if it fails 3
consecutive PT studies.
Trihalomethane PT acceptance criteria also changed
when the DBF Rule became effective in January
2002. In the past, a laboratory reported the total
THM concentration in the PT sample, and passed
the PT if the value reported was within ±80% of the
true value. Under the DBF Rule, each THM
-------
concentration must be reported, evaluated and
passed individually to pass the PT sample. The
DBF Rule also states that if a laboratory fails one
THM, it cannot be certified for TTHMs, but must
analyze another PT sample and pass all four of the
THMs to be certified to analyze compliance
monitoring samples for total trihalomethanes.
Laboratories must use EPA Methods 502.2, 524.2,
or 551.1 to analyze for THMs. Methods required
for analysis of HAAs are EPA 552.1 or 552.2 or
SM 6251B (552.2 is recommended over 552.1).
Laboratories must use EPA Methods 300.0 or 300.1
to determine chlorite and Method 300.1 to
determine bromate.
The DBP Rule also requires that water systems
monitor for TOCs. The regulation requires the TOC
analyses be performed by a party approved by the
State. This is the same language that has been used
in the past for other non-MCL requirements such as
pH, turbidity, alkalinity, etc. Standard Methods
531 OB, C or D must be used.
PT Data Reporting
Guidance
In order for the providers to process the studies
properly and more efficiently, please follow the
guidelines below when reporting your PT results.
Always fill out form correctly and completely.
Include the laboratory name, address, contact person
and the unique EPA laboratory ID code.
Procedures for finding and/or getting a unique
laboratory code are explained on page 5.
If the laboratory is analyzing a subset of the
contaminants in a PT sample, only enter data in the
report field when that contaminant is being
analyzed. That is, if you do not want to report or be
evaluated for a contaminant, leave that data field
blank.
If you want to be assessed for a contaminant but
determine that it is not present, use a < value with
your minimum reporting level (MRL) or your
method detection limit (MDL) whichever the
laboratory prefers. The NELAC PT committee is
developing a list of PT reporting limits, which a
laboratory may use and be confident that the value
is lower than the acceptable range for PT samples.
Never report a zero or an alpha character in the data
field.
Micro Proficiency
Testing Studies:
What is Considered
Proper Analysis?
Each microbiology performance test (PT)
consists of ten samples to be analyzed as a
single PT sample set. These are shipped in either
lyophilized, dehydrated, or aqueous condition. Each
PT sample set should be analyzed using one method
only, i.e., by either the Membrane- Filtration (MF),
Presence-Absence (P-A), or a Chromogenic/
Fluorogenic method. Each of the ten samples must
be analyzed and reported for the presence or
absence of total coliform bacteria, and then for the
presence or absence of fecal coliform/E. coli
bacteria. Each set is randomly composed of
samples that are: l)total coliform absent, fecal
coliform/E. coli absent, 2) total coliform present,
fecal coliform/E. coli absent, 3) total coliform
present, fecal coliform/E. coli present, and 4)
blanks.
Acceptable performance for the analysis of total
coliform bacteria requires the correct analysis of a
minimum of 9 out of the 10 samples, with no false
negative reported values. Acceptable performance
for the analysis of fecal coliform/E. coli bacteria
requires the correct analysis of a minimum of 9 out
of the 10 samples, with no false negative reported
values. In other words, one false positive may be
reported for each analyte. The PT provider will
issue a report indicating the acceptable performance
for the analysis of total coliform bacteria and the
acceptable performance for the analysis of fecal
coliform/.^1. coli bacteria, utilizing one technology.
The PT sample set may not be split, in any manner,
to run more than one technology.
-------
Radiological PT
Samples Now Available
"|3 adiological performance testing samples are
.lAjtiow available from a NIST approved provider.
All laboratories wishing to maintain certification for
these parameters should successfully analyze one set
per year. If the alpha emitters and a mixed group of
the other regulated contaminants are analyzed, that
should suffice as a complete set.
Websites
Fax It To Us
Please add/change (circle one) my name to the
Labcert Bulletin mailing list.
Name:
Company:.
Address:
Telephone:.
Fax#:
Fax to: Susan Hagedorn
USEPA - TSG
26 W. M.L. King Drive
Cincinnati, OH 45268
513-569-7191
An electronic version of this publication
and more can be found on the Office of
Ground Water and Drinking Water website:
http ://www.epa. gov/safewater/standards.html.
This site also has information about drinking
water regulations and laboratory certification.
The "Manual for the Certification of Laboratories
Analyzing Drinking Water," the errata sheets for
this manual, and past issues of the Labcert
Bulletin can all be found at this address.
Other websites that you may find useful are:
www.epa.gov/safewater/faq/sco.htm This site
has been very useful to the editors. It lists
certification contacts for every state and also gives
links to some of the states' lists of laboratories
certified for drinking water analyses. There are
links for about half of the states, the ones that
have electronic lists of their certified laboratories.
www.epa. gov/ttn/nelac/ This site contains the
NELAC Standards, lists NELAC Accrediting
Authorities and accredited laboratories, and has
information about past and future NELAC
meetings.
www.ts.nist.gov/ts/htdocs/210/214/scopes/progra
ms.html lists NIST accredited PT providers.
www.epa.gov/ogwdw/regs.html You can find the
drinking water regulations at this site.
www.epa.gov/ogwdw/methods/methods.html.
lists all promulgated methods and contains copies
of some methods.
www.epa. gov/quality/ The is the EPA Quality
Staffs home page and all EPA Quality
Documents and requirements can be found at this
website as well as available QA training and
information about the annual EPA QA meeting.
-------
&EPA
United States
Environmental Protection
Agoncy
Office of Ground Water and Drinking Water
Cincinnati, OH 45268
EPA-815-N-02-001a
January 2002
PRESORTED STANDARD
POSTAGE & FEES PAID
EPA
PERMIT NO. G-35
Official business
Penalty for Private Use
S300
In This Issue,..
S NELAC 7 Highlights
/ More Contaminants Require
Certification
S New PT Acceptance Criteria for
THMs
S More on Proficiency Testing
Requirements
i/ Some Useful Websites
Recycled/Recyclable
Printed with vegetable-based ink on paper that
contains a minimum of 50% post-consumer fiber
and is processed chlorine free.
------- |