Improvement Advisory Committee
The Secretary of Health and Human Services is authorized under Section
353 of the Public Health Service Act, as amended, to establish standards
to assure consistent, accurate, and reliable test results by all clinical
laboratories in the United States. The Secretary is authorized under
Section 222 to establish advisory committees.
The Clinical Laboratory Improvement Advisory Committee (CLIAC) was
chartered in February 1992 to provide scientific and technical advice and
guidance to the Secretary and the Assistant Secretary for Health regarding
the need for, and the nature of, revisions to the standards under which
clinical laboratories are regulated; the impact on medical and laboratory
practice of proposed revisions to the standards; and the modification of
the standards to accommodate technological advances.
The Committee consists of 20 members, including the Chair. Members are
selected by the Secretary from authorities knowledgeable in the fields of
microbiology, immunology, chemistry, hematology, pathology, and
representatives of medical technology, public health, clinical practice,
and consumers. In addition, CLIAC includes three ex officio members, or
designees: the Director, Centers for Disease Control and Prevention; the
Commissioner, Food and Drug Administration; the Administrator, Centers for
Medicare & Medicaid Services (formerly, Health Care Financing
Administration); and such additional officers of the U.S. Government that
the Secretary deems are necessary for the Committee to effectively carry
out its functions. CLIAC will also include a non-voting liaison
representative who is a member of AdvaMed (formerly, Health Industry
Manufacturers Association) and such other non-voting liaison
representatives that the Secretary deems are necessary for the Committee
to effectively carry out its functions.
Due to the diversity of its membership, CLIAC is at times divided in
the guidance and advice it offers to the Secretary. Even when all CLIAC
members agree on a specific recommendation, the Secretary may not follow
their advice due to other overriding concerns. Thus, while some of the
actions recommended by CLIAC may eventually result in changes to the
regulations, the reader should not infer that all of the advisory
committee's recommendations will be automatically accepted and acted upon
by the Secretary.
CALL TO ORDER INTRODUCTIONS/FINANCIAL
Dr. Toby Merlin, CLIAC Chair, called the CLIAC meeting to order, and
reviewed the role of this Advisory Committee. Dr. Robert Martin, Director,
Division of Laboratory Systems (DLS), Public Health Program Practice
Office (PHPPO), Centers for Disease Control and Prevention (CDC), welcomed
CLIAC members. All CLIAC members made self-introductions and disclosure
statements of their relevant financial interests as they relate to topics
to be discussed during the CLIAC meeting.
PRESENTATIONS AND COMMITTEE DISCUSSION
Centers for Medicare & Medicaid Services (CMS)
Update, formerly Health Care Financing Administration (HCFA)
Expanded Certificate of Waiver (COW)/Provider-
Performed Microscopy Procedures (PPMP)
Studies Addendum A
Ms. Judy Yost, Director, Division of Outcomes and Improvement (DOI),
Center for Medicaid and State Operations (CMSO), introduced Ms. Daralyn
Hassan, DOI, CMSO, who presented the findings from the CMS COW/PPMP
Project. Ms. Hassan gave a brief background of the project, describing the
pilot study of a random sample of 100 waived and PPMP laboratories in
Colorado and Ohio, and the expanded study of 270 waived and 190 PPMP
laboratories in 8 additional states. The additional states were chosen to
include a broad representation of laboratories in the 8 CMS regions not
represented in the pilot study. The data for this project were gathered
during on-site inspections using standardized check-lists and post-survey
questionnaires. The quality and certification problems found in the
expanded study corroborated the findings of the pilot study, as well as
the findings of separate studies conducted by CDC and the Office of the
Inspector General (OIG). Ms. Hassan concluded by reviewing recommendations
made by CMS and OIG.
Committee members responded favorably to the study, but questioned
whether CMS has the authority and resources to implement the
recommendations. Ms. Yost explained CMS has legal authority to carry out
the recommendations listed but, because the agency is currently undergoing
a change in leadership, does not have final authority. She did indicate
the feasibility of accomplishing the recommendations, and CMS is
evaluating the information to determine the best use of existing resources
in implementing these recommendations.
Several CLIAC members noted the need for outcomes data regarding
laboratory practices. Ms. Hassan acknowledged the concern, but pointed out
many laboratories dont see patients; therefore, it is difficult to
obtain outcomes data. Ms. Yost indicated the best CMS could do is to look
at risk of outcome. Some Committee members noted, despite the difficulty,
CMS should combine anecdotal data with a formal assessment and
quantification of outcomes. One Committee member suggested the burden of
collecting outcomes data should not fall to the regulatory agencies, but
rather to the groups or individuals who say regulations are not necessary
to ensure the quality of laboratory testing. Several members agreed.
Suggestions were made that, because many problems identified in waived/PPMP
laboratories result from laboratories not following manufacturers test
instructions, perhaps the FDA could assist by requiring manufacturers to
simplify instructions. Dr. Steven Gutman responded that the FDA is
concerned with issues pertinent to labeling, and welcomes any suggestions
as to mechanisms that would maximize the likelihood of users following
instructions. The manufacturer liaison to CLIAC noted diagnostics
manufacturers are also interested in ways to simplify test instructions
and ensure they are read and followed. A suggestion was made that
manufacturers use incentives to educate users, thereby increasing
compliance to follow package insert instructions. For example,
manufacturers could offer Internet training to users, giving rebates on
test kits to laboratories whose staff participate in the training.
Committee members acknowledged the labeling challenges, and concluded
education and training are critical for reducing problems.
Food and Drug Administration (FDA)
Dr. Steven Gutman, Director, Division of Clinical Laboratory Devices (DCLD),
Office of Device Evaluation (ODE), Center for Devices and Radiological
Health (CDRH), FDA, updated the CLIAC on FDA activities relevant to CLIA.
He reviewed the FDA and DCLD personnel status and explained that DCLD is
undergoing re-organization, going from three to six branches. He discussed
FDAs CLIA test complexity activity; their work to better define the
waiver process; and the status of the waiver program. Dr. Gutman also
reviewed plans and activities pertaining to genetic testing and shared
several website addresses for FDA guidance documents. In conclusion, he
summarized the FDAs strategic plan, including new management visions
In response to Dr. Gutmans discussion of the FDA plans to develop a
process for the review of genetic tests, several Committee members asked
why the Secretarys Advisory Committee on Genetic Testing (SACGT)
recommendations for FDA review of genetic tests were revised. Dr. Patricia
Charache, CLIAC member serving on the SACGT, explained the numbers of
genetic tests in use are much higher than anticipated. To make the
recommendations feasible, it became necessary to develop strategies for
limiting the number of tests requiring FDA review. Thus evolved a two-path
concept for oversight. Existing tests that are better understood should
require a less stringent review and will be delegated to a consortium,
while new tests will be reviewed by the FDA. Dr. Charache acknowledged
there are flaws in the strategy, but assured the Committee the FDA is
using professional and industry forums for assessing and resolving issues.
Members of the Committee suggested it is critical to determine clear
and concise definitions of old, new, and home-brew
tests. Without clear definitions, a double standard could evolve between
home-brew and commercial tests. They also reminded the FDA of the
importance of considering the impact federal regulations and validation
requirements could have on the development of tests for orphan diseases.
Waiver Workgroup Report
Dr. Barbara Goldsmith, Chair of the Waiver Workgroup, reported on the
April 11, 2001 meeting of the Waiver Workgroup, formed to provide input to
CLIAC on the FDA Draft Waiver Guidance. She reviewed the background for
the waiver processes and the 2/01 CLIAC Recommendations to the FDA Draft
Waiver Guidance. Dr. Goldsmith then presented the issues considered by the
Waiver Workgroup, including home use approval, accuracy, comparability
studies, risk of harm, appropriate tests for waiver, quality control
testing, labeling, surveillance/post-approval monitoring, general
comments, and concerns.
Dr. Merlin suggested the Committee frame their discussion around each
of the issues presented by the Workgroup to develop a set of comments and
recommendations. The Committee agreed, and as they discussed each
suggestion made by the Workgroup, they accepted the proposals in the
report, or made slight modifications. Pertinent discussion for each topic
addressed by the CLIAC follows. A complete set of CLIAC comments and
recommendations to the FDA Draft Waiver Guidance (including this meeting
and previous meetings) is found within Addendum D.
Home Use Approval
- Dr. Gutman was asked to review the criteria for home-use or
over-the-counter (OTC) approval. He responded the criteria specify the
product must be simple, and a lay-user can generate the same signal as
a laboratory professional. There is no threshold for accuracy for
home-use approval other than obtaining a clinically meaningful signal.
The fundamental differences in the criteria for home-use approval
versus criteria for waiver approval are in the approach to evaluating
accuracy and in the assessment of risk and benefits of information in
the hands of a lay-user.
- Some Committee members voiced concern that, because the approval
criteria for home-use tests are not equivalent to the approval
criteria for other waived tests, a double standard exists and the
home-use process has become a back-door for waiver approval.
Many members disagreed with home-use approval resulting in automatic
waiver. Dr. Merlin reminded the Committee the FDA Modernization Act of
1997 (FDAMA) specifies home-use tests are waived. Also, Dr. Merlin
noted, the FDAs Draft Waiver addresses waiver issues, not home
testing issues. Since FDAMA specifies that home-use tests are waived,
the Committee can only recommend the FDA re-evaluate the criteria for
home-use approval. Dr. Gutman indicated he would take the
recommendation of the Committee to the FDA legal staff for
The Committee suggested the home-use and waiver approval processes
should be harmonized to the extent possible. In doing so, the quality of
home-use tests should mirror the quality of more sophisticated clinical
tests. Dr. Gutman responded there are opportunities within the
stress/flex analysis and quality control recommendations to make the two
processes more equivalent. He indicated the FDA is currently in the
process of assessing the process for clearance of OTC products.
- Several members commented home-use tests are intended for
lay-users in a home setting. Using these tests in clinical settings
(e.g., physician office laboratories, emergency rooms, or intensive
care units) might be considered off-label use, which results in
a test being considered high complexity under CLIA and not appropriate
for waiver. Furthermore, this practice might lead to dangerous
outcomes. One example given was the evaluation of anti-coagulant
dosages based on results from a home-use prothrombin time device. A
physician member noted accurate prothrombin time results are critical
in an emergency room and using test results from a home-use device,
which can be inaccurate, could lead to unnecessary transfusions or
inappropriate anti-coagulant treatment. Many Committee members noted
these monitoring devices, designed for self-use by lay-users, are
inappropriately used as diagnostic tools by health care providers.
- The manufacturers liaison pointed out a product cleared by the
FDA for home-use is waived by law and can be used in laboratories,
without being considered an off-label use.
- Dr. Merlin summarized that CLIAC has significant concerns about
testing approved for home-use being performed in a clinical setting.
This can have serious public health consequences and needs to be
addressed. In granting home-use approval for tests, CLIAC recommended
the FDA consider all venues in which the tests are likely to be used,
and evaluate the risks and benefits of testing these products in the
- Committee members readdressed the use of the word accuracy in
FDAs Draft Waiver Guidance. Traditionally, accuracy is based on
comparing test performance to a measure of truth, such as a reference
method. The committee members emphasized agreement of test results
between a lay-user and a laboratory professional is not accuracy, but
is comparability, and recommended FDA change accuracy studies
to comparability studies in the Draft Waiver Guidance.
- One CLIAC member suggested waived tests should have higher accuracy
standards than moderate or high complexity tests cleared through the
FDA 510(k) process. Another member agreed, noting waived tests are
used by lay-users with no regulatory oversight, and it may be
appropriate to require a higher accuracy threshold for waiver approval
than for moderate or high complexity tests, performed in laboratories
required to meet standards for personnel, proficiency testing, quality
control, and quality assurance.
- Committee members recommended accuracy assessment for qualitative
waived tests include the evaluation of clinical sensitivity, clinical
specificity, the predictive value and consider the prevalence of
- The CLIAC supported the workgroup report stating comparability
studies include intended users in an intended use setting, and show
comparable performance between trained and untrained-users. One member
questioned the comparability studies between trained and
untrained-users in the draft guidance document. The studies evaluate
the performance of a small number of trained users performing many
tests, versus the performance of many lay users performing a few
tests. Dr. Gutman replied this was intentional to magnify any problems
with tests performed by lay-users.
Risk of Harm to Patients
- One member questioned whether the FDA would consider risk of harm in
waiver evaluations, since it is impossible to define unreasonable,
risk, and harm. Others noted all laboratory tests have
some risk of harm if performed incorrectly.
- One Committee member expressed concern that some tests, such as HIV
tests and genetic tests, could have a great potential for harm if
performed in settings that do not provide counseling. The members
recommended, in assessing risk of harm, all phases of testing (i.e.,
pre-analytical, analytical, and post-analytical) should be considered,
as well as the context of testing and clinical impact of waived tests.
Appropriate Tests for Waiver
- Some Committee members questioned whether tests requiring follow-up
testing should be eligible for waiver approval. They expressed concern
that laboratories often fail to conduct follow-up testing in
accordance with manufacturers instructions (e.g., failure to
follow-up negative rapid strep tests with throat culture). They asked
whether there was a mechanism for gathering data on the frequency of
follow-up testing and potential uses for such data. Ms. Yost replied
CMS could gather the data through existing resources for use as an
educational tool, but if a laboratory continuously failed to conduct
follow-up testing, CMS would take action. A suggestion was made that
accreditation organizations could address follow-up testing in their
- Some members also questioned whether screening tests, tests
requiring additional confirmation, or tests for diseases whose
prevalence varies in different populations should be eligible for
waiver approval. After discussion, it was decided these tests should
not be automatically excluded for eligibility, but should be
considered on a case-by-case basis, depending on the nature of the
test and the potential for benefit versus harm.
Quality Control (QC) Testing Labeling
The CLIAC supported the workgroup comments and suggestions, without
CLIAC strongly supported Section VI of the FDAs Draft Guidance,
recommending manufacturers establish a surveillance plan for post-approval
monitoring of waived tests, but many expressed concern that this is
proposed as voluntary rather than required. One member pointed out
voluntary reporting of problems could penalize those manufacturers who
chose to do it, whereas mandatory reporting would subject all
manufacturers to the same standards. The manufacturer liaison stated the
post-approval surveillance criteria could limit technology and increase
the cost of tests. Committee members noted the post-approval monitoring
should be a requirement, but it needs to be feasible and appropriate, and
should consider the burden on the manufacturer.
- The Committee discussed who should be responsible for gathering
post-approval surveillance data, noting that conflict of interest
issues could arise if manufacturers gather their own data. One member
suggested the Committee make a recommendation that this data be
gathered by someone other than the manufacturer.
CLIAC recommended a sunset provision for re-evaluating waived
test performance 3-5 years after approval, using field performance data.
They added a mechanism should be developed for withdrawal of waiver
approval, if post-approval performance data varies substantively from the
original waiver approval data.
Committee members readdressed the findings of the COW/PPMP report,
presented by Ms. Hassan of CMS, relating to waived testing errors. They
agreed education and personnel competency assessment are critical in
reducing these errors but were unsure who would ultimately have
responsibility for their implementation. Suggestions were made that
manufacturers and/or physicians should be responsible. Some members
disagreed, stating personnel competency should not be the responsibility
of manufacturers. One member pointed out this would consume an inordinate
amount of time with no reimbursement. There was a suggestion that CMS
oversee personnel competency. Ms. Yost said CMS currently has no oversight
of waived testing personnel, but they would analyze survey data and
determine whether training was adequate. Dr. Merlin noted waived testing
is not restricted to traditional medical settings and these tests are
broadly available. It is possible testing could be performed in any venue
(e.g., pharmacies, fast food restaurants, etc.), and this would mean there
may not be a physician responsible for interpreting the results.
As explained, the CLIAC revised the Waiver Workgroup recommendations,
based on discussions of the full committee meeting. A motion was made and
seconded for the CLIAC to adopt these recommendations and forward them to
the FDA as formal comments. [Addendum E]
HIV Rapid Tests
Dr. Tom Hearn, Deputy Director, DLS, PHPPO, discussed CDCs strategic
plan for HIV prevention, explaining an important part of this plan is to
test HIV-infected individuals at earlier stages of their infection. One
possible route for achieving this is increasing the access to testing in
nontraditional laboratory settings, through the use of rapid tests. The
CLIAC was asked to consider the best mechanism to assure nontraditional
access to testing, while maintaining high quality test results. Dr. Hearn
also asked the CLIAC to consider rapid HIV tests in the context of the FDA
Draft Waiver Guidance.
Dr. Bernard Branson, of the National Center for HIV, STD, and TB
Prevention (NCHSTP), CDC, asked the CLIAC to consider whether there should
be different criteria for waiving HIV tests than for waiver approval of
other tests. Dr. Branson stressed NCHSTP wanted to obtain the insight of
the Committee with regard to HIV tests, and whether the Committee could
identify items not included in the current FDA Draft Waiver Guidance that
should be considered for HIV tests.
Dr. Elliot Cowan, Chief of the Human T-cell Lymphotropic Virus Section
of the FDA Center for Biostatistics, announced an upcoming Blood Products
Advisory Committee (BPAC) meeting for the Center for Biologics,
Evaluation, and Research on June 14, 2001. He noted the issue of CLIA
waiver for rapid HIV testing would be discussed during this meeting.
- Dr. Merlin noted there are elements other than simplicity and
accuracy in considering HIV tests for waiver. Several Committee
members re-emphasized concern for the potential for harm if these
tests were performed in settings that do not provide pre- and
- The CLIAC agreed counseling is critical to the clinical management
of HIV and discussed the likelihood of patients returning for
counseling if preliminary test results are reported on-site.
- Some members questioned the necessity of classifying rapid HIV tests
as waived, rather than moderately complex, which would subject them to
some oversight. The members expressed concern that if rapid HIV tests
were waived, nontraditional testing sites such as singles bars and
bath houses could provide HIV testing for their customers with no
regulation, oversight, personnel standards, etc.
- One member stated we are at a crucial turning point in HIV
management, where focus needs to be shifted to populations that are
hard to reach, and are not yet being tested.
- One Committee member suggested access could be increased by
providing these rapid HIV tests, presently categorized as moderately
complex, under the limited public health certificate, rather than
offering them as waived tests. Dr Hearn clarified that a provision in
the CLIA regulations allows multiple (no limit to the number of sites)
public health laboratories to perform up to a total of 15 moderate and
waived tests under a single limited public health certificate.
Laboratories operating under a limited public health certificate must
comply with both personnel standards and quality control/quality
assurance requirements. Several committee members recommended further
consideration of the limited public health certificate.
- One member pointed out the BPAC is focused on blood product safety,
and may not be aware of issues facing a diagnostic laboratory. Dr.
Cowan responded that several people from CDRH would be present at the
meeting, and they are familiar with CLIA. He added there would be an
open public session at this meeting, where statements may be
presented. The CLIAC recommended a representative make a statement at
the BPAC meeting, expressing that HIV tests are inappropriate for the
waived category. A letter was drafted and approved by CLIAC.
Dr. John Boffa
Dr. John Boffa, of the American Association of Bioanalysts (AAB),
stated AAB is concerned about the absence of quality control and
proficiency testing requirements for waived testing. He suggested the FDA
consider a new, low complexity category of testing. Tests considered for
waiver could initially be placed into this low complexity category; then,
once they have demonstrated accuracy and precision in the field, they
could be approved for waiver.
Dr. Bernard Branson
In response, Dr. Bernard Branson, NCHSTP,CDC, acknowledged the
Committees concerns regarding waived testing. However, he stated for
some screening tests or tests needing follow-up, such as HIV, STD, and
hepatitis, the only access to testing may be through nontraditional
settings, and it is critical to ensure this access. For the benefit of the
public health, he suggested CLIAC consider their recommendations for
waived testing and base their decisions on the severity of disease and
risk/benefit analysis. He also suggested consideration be given to the new
category, as proposed by Dr. Boffa.
Report to CLIAC on SACGT Meeting of May 2-3,
2001 Addendum H
Dr. Patricia Charache, CLIAC member serving on the SACGT, updated the
CLIAC on two SACGT meetings held on February 15-16 and May 2-3, 2001. Her
report highlighted three major areas discussed during the May SACGT
meeting: 1) FDAs progress on the development of a test review template
for genetic tests and review processes; 2) approaches to the development
of clinical guidelines for genetic testing; and 3) ongoing activities of
the five SACGT work groups on data collection, education, rare disease
testing, access, and informed consent/ institutional review boards (IRBs).
Dr. Charache also summarized the SACGT discussion regarding the
responsibility of the laboratory director to ensure the clinical validity
of genetic testing.
Pre-market Approval and Proposed Template for Reviewing
- There were comments that several terms in the template could be
confusing and need to be more clearly defined. Examples were: clinical
validity, analytical validity, and clinical utility.
- Some members commented certain information required on the template,
such as penetrance of rare mutations, may be unavailable. Dr. Charache
responded unavailable is a valid response in instances when the
required information is not available.
- Several Committee members noted the proposed FDA review of home-brew
(laboratory-developed) tests would be a duplication of regulatory
oversight, since laboratories are already required to comply with
applicable CLIA requirements in ensuring the quality of
laboratory-developed tests. These members were concerned the
additional laboratory burden could limit access to new genetic tests.
- Some members expressed concern that the proposed FDA test review
could be particularly punitive for small laboratories and academic
laboratories, which are already under great financial pressure.
- One Committee member noted the information required on the template
would be applicable for all home-brew tests, not just genetic tests.
- Alternatives to the FDA test review were suggested, including
revising the CAP laboratory inspection checklist to include the
template as a component of the procedure manual criteria.
- Dr. Gutman clarified the template was intended to contain core
elements a laboratory should have available before offering a test
clinically and was driven by pure science. He pointed out, while
the regulatory endpoint is uncertain at present, the FDA is
considering alternative pathways, including a CLIA-based approach and
mechanisms through collaboration with professional organizations. Dr.
Martin suggested the test review template be piloted to ensure its
compatibility with various types of genetic tests.
Rare Disease Testing
- One Committee member noted the majority of genetic diseases are rare
but the list of rare diseases may change rapidly as knowledge of
associations between specific genotypes and health conditions
increases. This member suggested it would be more feasible to define
conditions that are common rather than rare.
- Several members were concerned that many research-oriented
laboratories without CLIA certification report test results to care
providers or patients, and do not understand they are providing
patient care testing that is subject to CLIA. These members pointed
out this problem could become greater as more researchers translate
their research results to patient care.
- One Committee member expressed concern about the SACGT effort to
protect laboratories performing low-volume rare disease testing. This
effort could create a back door to avoid the scrutiny of formal
pre-market reviews, by performing testing in a home-brew situation.
Informed Consent/IRB Review
- One Committee member commented that one brochure might not be
sufficient to explain the various types of genetic testing and
appropriate informed consent to the general public. This member also
suggested external representation be added to address the issue of
patient privacy, along with informed consent.
Laboratory Director Responsibilities
- Concern was expressed that individuals who currently serve as
laboratory directors might not have the specific training or
experience to fulfill the proposed responsibilities for genetic
testing. It was clarified that the proposed responsibilities may be
delegated to the technical supervisor and the clinical consultant,
while the laboratory director would retain ultimate responsibility for
the quality of testing offered by the laboratory.
- One member commented that the SACGT-suggested responsibilities of
the laboratory director for not performing a test on the wrong
population group would be difficult in practice and time-consuming,
since laboratories would need to contact the individual ordering the
test and explain the reason for rejection. Another member suggested a
CPT code be established to reimburse laboratories for the additional
time spent to contact health care providers.
The Committee asked Dr. Charache to present a report at the August 2001
SACGT meeting, summarizing the CLIAC discussion on the FDA test review
template. Dr. Charache agreed to report back to the CLIAC on the
development of the white paper on principles of informed consent by the
SACGT Consent/IRB Workgroup.
CD-ROM Demonstration - Genetic Testing in Clinical
Dr. Joel Henderson, Chair of Medicine at Dartmouth University,
provided a demonstration of a multi-media genetic training program,
developed through a cooperative agreement between Dartmouth Medical
School and the CDC. This CD-ROM program utilizes virtual clinic
scenarios and is intended for training non-geneticist health care
providers. Dr. Henderson reported the program is in the final phase of
development and a complete version will be available in the near future.
He noted the challenge of maintaining the current information in the
training program in the midst of the many changes in genetic testing.
Centers for Disease Control and Prevention (CDC)
Public Health Workforce Development
Dr. Maureen Lichtveld, Associate Director for Workforce Development,
PHPPO, gave an overview of a global and national implementation plan for
public health workforce development. She summarized the vision, goal,
guiding principles, and key planning assumptions for the implementation of
a plan to ensure public health preparedness for current and emerging
health threats. The plan includes monitoring workforce composition/project
needs; identifying competencies/developing curriculum; designing an
integrated learning system; using incentives to assure competency;
conducting evaluation and research; assuring financial support; and
establishing coordination and accountability. Dr. Litchtveld noted genetic
testing will be one of the core competencies, and CDC is interested in
receiving the CLIACs input on the laboratory workforce as it pertains
to multi-disciplinary genetic issues.
Dr. Martin noted genetics is becoming a model for collaboration between
medical care and public health. This model may lend itself to issues that
need to be addressed regarding HIV testing, bioterrorism, and
antimicrobial resistance, where there must be integration of public health
with medical care.
Concern was expressed by the Committee regarding the absence of
behavioral health/behavioral modification issues, such as violence,
obesity, and tobacco as core competencies in the workforce development
Chronology of Cytology Proficiency Testing
Ms. Rhonda Whalen, Branch Chief, Laboratory Practice Standards Branch (LPSB),
DLS, PHPPO, presented a chronology of the activities associated with
implementing the cytology proficiency testing (PT) provisions in the CLIA
law. She described the DLS development and testing of CytoViewTM, a
prototype system for computer-based cytology PT. She then described a
study, done in collaboration with Analytical Sciences, Inc. (ASI), that
compared workplace performance to PT scores, using both formats of PT,
glass slide and computer-based testing. The study showed some correlation,
though not strong, between workplace performance and PT scores.
Individuals performed better on the glass slide test, perhaps because of
unfamiliarity with the computer format and the slow speed of the computer
responses. A limitation of the ASI study was that pathologists were tested
as cytotechnologists, rather than as reviewers of slides pre-marked by
cytotechnologists. Based on the evaluation of the study, CytoViewTM was
re-designed and renamed CytoViewTM II. Initial demonstrations of the
CytoViewTM II at professional meetings have received favorable responses
due to the increased sharpness of the images and the enhanced ability of
the second generation prototype to focus on different planes of an image.
CDC plans to pilot test the second generation system.
Ms. Whalen stressed the CLIA PT regulations specify glass slide tests,
so for computer-based PT to be approved, the regulations would have to be
changed. Revising the regulations requires rulemaking, which includes
publishing proposed regulations and soliciting public comments before the
regulations are finalized. Any changes to the regulations would not
eliminate glass slide testing, but rather would provide the option of
computer-based testing. The goal has been to develop the technology and
ensure it is comparable to glass slide testing and appropriate for
proficiency testing cytology personnel. This system offers the advantage
of immediate re-testing of any individual who fails the first test.
However, it is anticipated that a glass slide retest would be given after
a repeated failure on a computer-based test. The ultimate vision is a
laptop version that can be taken to laboratory sites for testing and
encouraging organizations to further develop CytoViewTM II to provide a
cytology PT program.
CytoViewTM II Demonstration
Mr. Eric Thompson, Health Scientist - Cytotechnologist, LPSB, DLS,
PHPPO, gave a CytoViewTM II software demonstration, illustrating the
controls and discussing the features on the demonstration software, as
well as some features planned for the final version.
- Dr. Sturman, New York State Department of Health, volunteered his
program as a test site, indicating New York has a glass slide PT
program in which around 1,000 cytotechnologists are tested.
- One member asked if CytoViewTM II PT would be distributed in a
CD-ROM format. Mr. Thompson replied the proficiency test would not fit
onto a CD-ROM, but the CD-ROM format could be used for educational
applications of CytoViewTM II.
- One member expressed approval of this technology for PT purposes,
and suggested this same technology could be applied in the hematology
and microbiology laboratory settings, which are also heavily reliant
- Concern was expressed regarding cytology proficiency testing of the
individual versus testing of the laboratory. One member noted this is
not unique to cytology; in the discipline of forensics, the individual
is tested and in environmental testing, the individual who happens to
be in the field at the time is the one who is tested.
- Because some laboratories perform well on PT but, in reality,
operate using poor laboratory practices, a suggestion was made that
CDC continue to assess whether externally administered PT reflects the
quality of work in the laboratory.
Medical Laboratory Personnel Shortage Act of
2001 Addendum L
The Committee discussed the Medical Laboratory Personnel Shortage Act
of 2001, a recently proposed bill to amend the Public Health Service Act.
A suggestion was made that the CLIAC draft correspondence supporting the
need for legislation to address the emerging laboratory workforce
shortage. The issue was raised as to whether it would be appropriate for
the CLIAC to support legislation in Congress.
Dr. Baker, Director, PHHPO, responded by stressing the need for
supporting laboratory quality, and accordingly, the need for a competent,
well-trained, highly skilled laboratory workforce. He noted, while HHS did
not ask for the CLIACs advice on this legislation, the Committee could
voice their support for the issues addressed in this legislation. CLIAC
decided to craft a statement expressing concern to the Secretary about the
shortage and its impact on public health, and requested the Secretary
convey this message to Congress. The Committee drafted and approved the
Dr. Martin responded to an inquiry from the CLIAC for an update of
plans for the Quality Institute, discussed at the February, 2001, CLIAC
meeting. He indicated DLS is currently involved in internal discussions
and plans to convene a Quality Institute in late spring or early summer of
No public comments were given May 31, 2001.
The Committee was reminded the next CLIAC meeting will be held
September 12-13, 2001. The meeting was then adjourned.
I certify that this summary report of the May 30-31, 2001, meeting of
the Clinical Laboratory Improvement Advisory Committee is an accurate and
correct representation of the meeting.