Record of Attendance
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Committee Members:
Dr. Toby L. Merlin, Chair
Dr. George G. Birdsong
Dr. Joseph M. Campos
Dr. Patricia Charache
Dr. Brenta G.C. Davis
Dr. Andrea Ferreira-Gonzalez
Dr. Jaime L. Frias
Dr. Ronald J. Gagne
Dr. Barbara M. Goldsmith
Ms. Cynthia S. Johns
Dr. Valerie L. Ng
Dr. Timothy J. O'Leary
Dr. Stewart Lee Richardson
Dr. Lawrence Mark Silverman
Dr. Lawrence S. Sturman
Dr. Roland Valdes, Jr.
Dr. Alice Schauer- Weissfeld
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Ex Officio Members:
Dr. Robert Martin
Dr. Steven I. Gutman
Ms. Judith Yost
Liaison Representative:
Ms. Kay A. Setzer, AdvaMed
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Centers for Disease Control and Prevention:
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Ms. Nancy Anderson
Dr. Rex Astles
Ms. Carol Bigelow
Dr. Joe Boone
Ms. Diane Bosse
Ms. Sandra Browning
Dr. Bin Chen
Ms. Deborah Coker
Ms. Sharon Granade
Dr. Tom Hearn
Ms. Theresa Lawrence
Dr. Ira Lubin
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Mr. Kevin Malone
Dr. Adam Manasterski
Ms. Priscilla Patin
Ms. Anne Pollock
Mr. Darshan Singh
Ms. Marianne Simon
Dr. Barbara Slade
Dr. Ana Stankovic
Dr. Steve Steindel
Mr. Howard Eric Thompson
Ms. Pam Thompson
Ms. Rhonda Whalen |
Clinical Laboratory Improvement Advisory Committee
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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.
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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.
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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 (CDC); the
Commissioner, Food and Drug Administration (FDA); the Administrator, Health
Care Financing Administration (HCFA); 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 the 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.
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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.
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Call to Order
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Dr. Toby Merlin, Chair
Chief Medical Officer and
Senior Vice President
Lovelace Health Systems
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Dr. Toby Merlin, CLIAC Chair, called the meeting to
order and reviewed the agenda. He pointed out that Dr. Edward Baker, Director,
Public Health Practice Program Office (PHPPO), CDC, and Dr. Robert Martin,
Director, Division of Laboratory Systems (DLS), PHPPO, CDC, were not present,
although Dr. Martin would participate in the second day of the meeting. He
noted CLIAC is a public meeting, and pointed out the times during which public
comments would be heard. Upon reviewing the role of CLIAC (to advise the
Department of Health and Human Services - HHS), Dr. Merlin requested the
members introduce themselves, and disclose statements of their relevant
financial interests and affiliations as related to the topics to be discussed
during the CLIAC meeting. He indicated any members with conflicts of interest
pertaining to votes taken during the meeting would be required to recuse
themselves from the voting procedure. Dr. Merlin extended a special welcome to
Dr. Bernard Statland, Director of the Office of Device Evaluation (ODE) at the
FDA.
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American Society for Clinical
Laboratory Science (ASCLS) Summit on the Shortage of Clinical Laboratory
Personnel (Addendum A)
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Dr. Brenta Davis
Chair, Department of Clinical Laboratory Sciences
University of Tennessee Memphis
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Dr. Brenta Davis reported on the Coordinating Council
for Clinical Laboratory Workforce (CCCLW) meeting [Addendum A], a followup to
the previous ASCLS Summit on the Shortage of Clinical Laboratory Personnel. She
explained the function and purpose of the CCCLW, delineating the organizations
involved in the effort. She described the status of the increasing shortage of
laboratory personnel (currently the highest vacancy rate in laboratories in 12
years), and its impact on healthcare. Dr. Davis then explained the components
of the CCCLW strategic plan to address the shortage (e.g., data collection,
marketing the profession, field guide, recruitment, and financing education),
the lead roles to be taken by participating organizations, and concluded by
explaining how CLIAC could provide assistance in the effort. She stressed that
CLIAC's presence at the CCCLW meeting was met with great enthusiasm.
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Committee Discussion
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The Committee agreed the shortage is significant and
broadly impacts the quality of laboratory testing in the United States. The
members suggested CLIAC could offer support in a number of ways, including:
requesting that federal agencies contribute data which may be helpful in
understanding the impact of the shortage, as well as how to alleviate the
shortage; raising the issue of laboratory shortages with other relevant
organizations; and lending support to the efforts of the National Research
Council to improve high school science teaching.
Concern was expressed that at a local level, hospital administrators do not
recognize that a problem exists. It was suggested that laboratory inspectors
carefully look at staffing levels to determine whether there are adequate
numbers of trained individuals performing testing. Perhaps hospital
administrators would take action if deficiencies are cited during laboratory
inspections.
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Some members cautioned that personnel shortages are
not restricted to the clinical laboratory community, but are evident in the
scientific community in general. It was suggested the pool of students entering
laboratory professions is becoming smaller due to poor or disconnected high
school science teaching, and that individual CLIAC members could offer
assistance to their respective Boards of Education seeking to improve high
school science teaching.
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Summarizing the views of the Committee, Dr. Merlin
concluded that:
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The Committee should request HHS to look carefully at what is needed to assist
in addressing the shortage;
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Representatives from organizations that might have leverage on these
activities, such as Human Resources Service Administration and the Joint
Commission on Accreditation of Healthcare Organizations, should be invited to
speak to the Committee during future meetings about steps they are taking to
address the issue; and
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Dr. Davis should continue to work with the CCCLW and CDC staff to keep the
CLIAC informed on this critical issue [which Dr. Davis agreed to do].
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| Polio Eradication Project (Addendum
B)
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Dr. Walter Dowdle
Director of Programs
Task Force for Child Survival and Development
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Dr. Walter Dowdle presented [Addendum B] his efforts
with the Task Force for Child Survival and Development, and the World Health
Organization's Global Polio Eradication Initiative. He explained the Initiative
and asked for CLIAC's support for this major global program for appropriate
containment of wild poliovirus, to prevent transmission from the laboratory to
the anticipated increasingly non-immune global community.
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Dr. Dowdle explained while it is fairly simple to
contain known sources of poliovirus in the laboratory, it is a more difficult
task to identify potentially infectious materials which could contain wild
poliovirus. He said of greatest concern are fecal and throat specimens for
which poliovirus is not suspected, particularly from specimens collected in
countries where poliovirus is endemic. In an effort to address this problem,
Dr. Dowdle described laboratory surveys to be conducted to identify and
inventory material potentially containing poliovirus. Laboratories identified
which retain such material will be notified to implement biosafety measures
consistent with the risks, i.e. inventory, containment, and disposal
procedures. Dr. Dowdle stressed since the U.S. is behind other countries in
containment of poliovirus, all U.S. laboratories should be surveyed. In
conclusion, he said the CLIAC could be extremely effective in encouraging
cooperation on such an inventory by creating a letter of endorsement. To
exemplify, he read a sample letter.
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Committee Discussion
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Dr. Merlin expressed CLIAC's support for CDC, and the
CDC's role in viral disease surveillance and eradication. He suggested the
Committee adopt a version of the letter proposed by Dr. Dowdle, appropriately
revised for the CLIAC. After reviewing the revised draft letter, the Committee
recommended its adoption [Addendum B].
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Clinical Laboratory Improvement
Amendments (CLIA) Updates (Addenda C-J)
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CENTERS FOR DISEASE CONTROL AND
PREVENTION (CDC) UPDATE
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Waiver Overview
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Ms. Rhonda Whalen, M.S.
Chief, Laboratory Practice Standards Branch (LPSB)
DLS, PHPPO, CDC
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To introduce the topic of waiver, and provide
background information for CLIAC discussion, Ms. Rhonda Whalen gave a brief
overview [Addendum C]. She reviewed the waiver criteria specified in the CLIA
law and the requirements for waived laboratories published in the 1992 CLIA
regulations, including the tests waived via the regulations. Ms. Whalen then
described the test complexity model on which the CLIA regulations are based,
and the difference in requirements for waived versus moderate complexity tests.
She mentioned the proposed rule of September, 1995, which clarified the waiver
criteria, and the FDA Modernization Act (FDAMA) of November, 1997, and the
changes therein. She noted at this meeting, CLIAC was being asked to provide
input on the FDA Draft Guidance for CLIA Criteria for Waiver, currently
available for public comment, and concluded by summarizing the current status
of waived tests.
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Committee Discussion
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An inquiry was posed as to whether there are personnel
standards for a laboratory director of waived testing, to which Ms. Whalen
replied that there are no personnel requirements (including qualification
recruitments for laboratory director) for waived testing. She stressed that
regardless of where waived testing is performed, the only regulatory
requirement is the laboratory must follow the manufacturer's test system
instructions.
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Concern was expressed that the statutory language for
waiver implies a moderate or high complexity test could be waived if there is
not a risk of harm. Ms. Whalen pointed out tests must be both simple and
low-risk, or be approved by the FDA for home use, to meet the waiver criteria.
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An inquiry was posed as to what extent states or
accrediting organizations have requirements that affect laboratories conducting
only waived testing. Ms. Whalen indicated some states and accrediting
organizations do not exempt waived testing from regulation. States and
accrediting organizations could apply higher standards than the federal
requirements, but they may not apply standards lower than federal requirements.
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An inquiry was posed as to whether a waived test could
be used in any location, including tests waived based on FDA approval for home
use. Ms. Whalen said waived testing could be performed at any location. Dr.
Merlin questioned whether a laboratory holding a certificate could bill
Medicare for reimbursement of waived tests. Ms. Yost responded that tests must
be ordered by a physician, and local medical review policies determine a
laboratory's Medicare reimbursement.
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Introduction to the Laboratory Medicine Sentinel
Monitoring Network Reports
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Steven Steindel, Ph.D.
Supervisory Health Scientist
Laboratory Practice Assessment Branch (LPAB)
DLS, PHPPO, CDC
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Dr. Steven Steindel introduced the representatives
from the Laboratory Medicine Sentinel Monitoring Network (LMSMN), who would be
reporting on their studies of waived testing practices [Addendum D]. He
described the role of a sentinel network, and explained that the LMSMN includes
three sites. After considering the proposed changes to the waiver criteria and
the resulting changes that might occur in waived testing, Dr. Steindel
explained the LMSMN decided to gather information on waived testing practices
in both traditional and waived-only laboratories. He indicated that two of the
states in the Network, Arkansas and Washington, used a survey-based approach to
their studies, collecting data from laboratories which volunteered to provide
information. However, New York was using an on-site survey program, noting that
as of September 2000 this program was in the pilot stage with information
gathered from more than 100 pilot laboratories.
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Pacific Northwest Sentinel Network Report
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Kathy LaBeau
Network Director
Pacific Northwest Laboratory Medicine
Sentinel Monitoring Network
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Ms. Kathy LaBeau presented the Pacific Northwest
Sentinel Network's findings on quality assessment of waived test systems
[Addendum E]. She described the background of the Pacific Northwest Network,
created in 1995, indicating there are 633 test sites in four states.
Ms. LaBeau briefly reviewed the findings of a January 1998 Network study on
quality control (QC) of waived testing, conducted on moderate and high
complexity laboratories in the Network. She noted the overwhelming finding was
a misunderstanding about the QC actually needed for waived test systems. As a
result, most testing sites were determining their own QC protocols. She then
described the October 2000 Network study of waived testing for which she
developed two questionnaires one targeted for waived and provider-performed
microscopy procedures (PPMP) laboratories, and one targeted for moderate and
high complexity laboratories. In both questionnaires, laboratories were asked
to list the waived tests they performed by manufacturer and brand names, and
describe their quality assessment activities for those specific waived test
systems.
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Committee Discussion
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An inquiry was posed as to what percentage of the
total number of CLIA-licensed laboratories in the states covered by the Pacific
Northwest Sentinel Network was represented by the 633 voluntary participants,
given the concern that the data collected might be skewed by the voluntary
participation. Ms. LaBeau said that she could not answer for the other three
states; however, Washington is a CLIA-exempt state program, which made that
state unique. She said Washington has 2,600 laboratories in its database, of
which about 75% were waived and PPMP, while the other 25% were laboratories
that would be inspected by the state or were accredited laboratories. She
acknowledged the data may be skewed to some extent, but she stressed the
percentage of waived/PPMP laboratories who volunteered to participate
correlated with the percentage of moderate/high complexity laboratories.
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An inquiry was posed as to whether personnel in the
waived laboratories might have been confused about the QC specified in test
system instructions. Ms. LaBeau indicated that concern about possible lack of
understanding was the reason the Network used different questionnaires, which
included definitions, for waived/PPMP and moderate/high complexity
laboratories.
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Some Committee members asked Ms. LaBeau to clarify
how, on one hand, laboratories noted that failure on procedural controls was
the indicator of a questionable erroneous test result, while, on the other
hand, very low numbers of procedural control failures were reported. She said
it indicated to her those laboratories did not believe controls are necessary
to assess the quality of test results, and the laboratories did not know how to
use information from QC testing.
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New York Sentinel Network Report
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Loraine M. Clarke, Ph.D.
Network Director
New York State Department of Health
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Dr. Lorraine Clarke presented information on the New
York Sentinel Network [Addendum F]. She indicated that in July 1965 New York
State became the first state to initiate a certification program for clinical
laboratories operating in selected areas of patient testing. The data she
presented to the CLIAC was obtained through the integration of the Network
studies with the Clinical Evaluation Program, which currently issues permits to
950 comprehensive laboratories, and has 2400 registered limited test sites. The
comprehensive laboratories include those that offer a wide range of laboratory
testing and include primarily hospital and independent laboratories, while the
2400 limited tests sites are those that restrict their testing either to using
waived devices or PPMP. Dr. Clarke estimated when they complete the
registration process for the limited test sites, the number should increase
from 2400 to about 4000 sites.
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Dr. Clarke said New York is a partially exempt state
in that their physician office laboratories receive oversite from the Physician
Office Laboratory Program, which contracts with HCFA to provide these services.
She said they developed questionnaires for each of the test methodologies for
waived tests and PPMP, which were designed to capture information relating to
the types of facilities in New York State performing waived and PPMP testing,
the personnel conducting the tests, and the testing and quality assurance
practices in place.
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Dr. Clarke then discussed the five most frequently
performed waived tests in New York State, the types of sites included in the
limited test site facilities, and the personnel working in the sites.
Dr. Clarke also reviewed data pertaining to the percentage of sites having
citations relating to different aspects of the testing process identified
during the on-site visits by their surveyors. She noted the data had been
further separated for the limited sites based on whether a site was affiliated
with a comprehensive site that might be providing guidance and oversight, and
then reviewed the conclusions thus far from their analyses of the data.
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Dr. Clarke mentioned that New York looked at
proficiency testing (PT) failure rates for waived tests performed in
moderate/high complexity laboratories participating in the New York State
Program, and they plan to initiate an on-site PT program for limited testing
sites.
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Arkansas Sentinel Network Report
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Jason Lee, Ph.D.
Network Director
Arkansas Department of Health
Division of Public Health Laboratories
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Dr. Jason Lee made the presentation on the Arkansas
Sentinel Network [Addendum G]. He indicated as of January 2001 Arkansas had
1760 laboratories with CLIA certificates, of which 411 (23%) were in the
moderate/high complexity category. He said there had been a shift to waived
laboratories, which now consisted of 77% of the laboratories in Arkansas. Dr.
Lee indicated that the data he was describing was derived from their fourth
survey for the Sentinel Network Project. He reviewed the Network's study
design, described the types of certificates in the Arkansas laboratories
surveyed, and explained the limitations of the survey. Dr. Lee noted public
health laboratories included some bordering states (e.g., Tennessee, Louisiana,
and Texas). He described the significant test classifications and the types of
test kits, and reviewed the standard types of QC testing they found
laboratories were performing, including electronic controls, and
"other" QC. He also described the tests reported for which no QC
testing was performed. He said the Network was interested in answering the
question, "Are waived/PPMP laboratories less likely to perform QC?"
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Based on the results of the survey, the Arkansas
Network concluded QC testing was performed in waived laboratories, but
inconsistently; explicit guidelines for CLIA compliance for each test would be
appropriate; types of tests with high rates of non-performance of QC were
primarily those which had a non-automated option (e.g., dipstick tests, ESR,
CuSO4 hemoglobin, etc.); and waived and PPMP laboratories were less likely to
use available QC measures than higher level laboratories, which may impact the
quality of patient test results.
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Committee Discussion
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With regard to the laboratories performing no QC
(liquid, reference, clinical, or electronic) and relying on the clinical
correlation, it was felt clinical correlation could not entirely substitute for
QC.
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Noting that New York seemed to show many more QC
problems than the other two networks, it was suggested that follow-up in the
Pacific Network and/or Arkansas with some sort of on-site validation might be
beneficial. Data from the accredited and non-accredited laboratories in
Arkansas were somewhat equivalent to the New York data for affiliated and
non-affiliated laboratories. Dr. Lee said that in the QC areas that Arkansas
measured, a large portion of the QC was identified as clinical correlation.
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HEALTH CARE FINANCING ADMINISTRATION
(HCFA) UPDATE
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Judith Yost, M.A., M.T. (ASCP)
Director, Division of Outcomes and Improvement
Center for Medicaid and State Operations
Health Care Financing Administration (HCFA)
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Ms. Yost delivered the HCFA update [Addendum H]. She
shared national data on trends in the CLIA program which agreed with
information presented by the Sentinel Networks. She noted there are
approximately 170,000 laboratories enrolled in CLIA, and the majority of CLIA
laboratories are not traditional laboratories. She also reviewed the number of
laboratories by certificate type, noting that the percentage of laboratories
not inspected (waived, PPMP) has increased since 1997. She clarified that PPMP
laboratories are moderate complexity laboratories, which are subject to patient
test management, and certain QC, personnel and PT standards, but are not
routinely inspected.
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Ms. Yost reviewed the number of CLIA accredited
laboratories enrolled by accrediting organizations, and described the annual
test volumes and certificate fees for physicians office laboratories,
hospitals, and independent laboratories. She went over the top four CLIA
deficiencies cited during three HCFA survey cycles, and the total number of
substantiated complaints. While the deficiencies remained pretty much the same,
over time, fewer laboratories had those deficiencies once they were inspected.
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She indicated that in December 2000 a regulation was
published extending the phase-in QC requirements applicable to unmodified,
moderate complexity tests, and qualifications for high complexity laboratory
directors.
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Ms. Yost then shared the Certificate of
Waiver(COW)/PPMP project findings [Addendum I], describing the history of the
project (initially evaluating laboratories in Ohio and Colorado), and shared
preliminary findings from the expanded pilot study. She reminded the CLIAC she
had previously presented the preliminary results of the pilot study, and
because of concerns regarding the extent and scope of findings in the initial
pilot, HCFA extended the study to an additional eight states. She said she
would share further findings at the May CLIAC meeting.
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Committee Discussion
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A comment was made that while data from the COW/PPMP
studies suggest there might be problems with the quality of testing, the data
do not indicate the clinical impact that may be associated with these issues of
test quality. Ms. Yost responded HCFA does not have data correlating test
results and clinical outcomes, except for unique areas such as pap smears for
which there are some outcome studies. In some cases, large laboratories conduct
their own outcome studies, but do not share their data given the liability
issues involved.
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Based on the data presented, it appeared 75% of waived
laboratories are not following the test system instructions. That raised issues
about how laboratories performing waived testing are monitored. Dr. Statland
suggested three key evaluation steps which include evaluating process, output,
and outcome. He noted the data presented pertained to the evaluation of
process. He said process deficiencies need to be linked to output deficiencies,
and output deficiencies could be assessed to some extent by proficiency
testing. The next step would be to relate output deficiencies to impact on
clinical outcome.
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Dr. Hearn acknowledged it is difficult to do ultimate
outcome correlates, particularly using health as a measure. Those who have been
involved in CLIA research began by looking at the types of methodologies to
use. If the assumption is that errors don't occur very often, then the number
of observations required to get meaningful data would be very high and quite
costly. He indicated CDC conducted one small study, published in the Journal of
the American Medical Association with the Ambulatory Sentinel Practitioners
Network where, prospectively, practitioners in the network agreed over a small
interval of time to record each time they encountered a laboratory test result
that appeared to be wrong and led to an adverse outcome. The outcome measure
was dependent on the physician, who documented each error; however, there was
no documentation of the errors they did not detect. Therefore, the clinical
correlate was based on the physician's bias. While the number of observed
errors are fairly small, they do occur and have some clinical impact. He said
CDC had also compared proficiency testing scores among previously regulated
laboratories with newly regulated laboratories. For all analytes evaluated, the
proficiency test scores were always statistically better in those laboratories
which had more regulatory experience, and consequently, good process control.
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One member agreed outcome measures are hard to obtain,
but one could assume that physicians ordered laboratory tests because they
expect test results to have some impact on patient care. Therefore, good
laboratory testing is better than poor laboratory testing.
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FOOD AND DRUG ADMINISTRATION (FDA)
UPDATE
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Draft Waiver Guidance
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Steven Gutman, M.D.
Director, Division of Clinical Laboratory Devices
ODE, FDA
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Dr. Steven Gutman discussed the FDA Draft Waiver
Guidance [Addendum J]. He indicated the draft, recently developed by the FDA to
provide guidance for manufacturers requesting waiver approval, was largely
derivative of the model previously used by the CDC. However, he added there
were some important design and statistical differences between FDA's guidance
document and the waiver proposed rule, and he said FDA, CDC, and HCFA were
anxious to receive CLIAC's input on the Draft Guidance. Dr. Gutman reviewed the
statutory basis for waiver approvals, including explanatory information from
the legislative preamble. He highlighted the elements in the Draft Guidance,
and stressed the document is non-binding even after it has been vetted by the
FDA.
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Bernard Statland, M.D., Ph.D.
Director, ODE, FDA
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Dr. Bernard Statland began by acknowledging the waiver
issues are challenging. He indicated two general goals of the FDA are to
protect the public health, and to promote new technology. He said the FDA is
concerned that products on the market be safe and effective, and at the same
time, the agency strives to encourage industry to develop innovative and
improved products. Two driving forces which may sometimes be in conflict with
regard to laboratory testing are access and quality, because as access to
testing is increased, there are concerns about quality being diminished. As a
greater emphasis is placed on achieving quality testing, there is concern that
access could be limited. Ultimately, the goal is to have both.
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Dr. Statland next mentioned postmarket surveillance of
waived tests, and pointed out the FDA is proposing total product lifecycle. The
FDA is trying to facilitate the entry of improved products into the
marketplace, but to carefully evaluate them after they have been approved. The
FDA is also trying to encourage manufacturers to make devices more robust and
resistant to user error and subjectivity.
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Dr. Statland emphasized the FDA is seeking CLIAC's
input on all aspects of the Draft Guidance. He said in addition to commenting
during the meeting, there were approximately 90 days for additional public
comments. He encouraged CLIAC members not only to make comments as a Committee,
but also as individuals and on behalf of their organizations. Dr. Gutman added
the FDA would particularly welcome alternative models, language, and
suggestions with respect to the Draft Guidance.
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Committee Discussion
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The Committee discussion focused on specific topic
areas pertaining to the FDA Draft Waiver Guidance as follows:
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Home Use Approval
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CLIAC members questioned whether the criteria for
automatic waiver based on approval for home use are equivalent to the waiver
criteria in the FDA Draft Guidance, and expressed concern that different
criteria may be used to obtain waiver. Dr. Gutman said the home use criteria
are not the same, and reviewed the steps for home use approval: 1) the test
must provide the same information for the lay user as for the professional
user; 2) a risk assessment must show that the test can be performed by lay
users; and 3) the benefits of home use must outweigh the risks. Studies for
home use approval require comparison of untrained to trained users, but do not
require accuracy or precision studies.
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Accuracy
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Concern was expressed about using "accuracy"
as a surrogate for "precision" in the Draft Guidance, noting that
accuracy is not "precision." One member suggested the dictionary
definitions be used to define "accuracy," "precision," and
"comparability." Other CLIAC members suggested "accuracy,"
as used in the Draft Guidance referred to "accuracy" in the hands of
untrained users at clinical decision points. Dr. Gutman acknowledged there is
disagreement about what is needed to demonstrate "accuracy" for
waived tests. Dr. Statland also noted "accuracy" is at the heart of
the controversy concerning waived tests. He said manufacturers demonstrate
accuracy through the 510(k) clearance process when a test is compared to a
well-credentialed working method, and for waiver approval, manufacturers should
compare equivalence between lay user performance and professional performance.
He indicated the FDA would consider defining terms, perhaps by adding a
footnote to the Guidance. However, he stressed in the Draft Guidance, FDA used
the words in FDAMA to ensure the deviation of the lay user versus the
professional user was not so significant as to make a difference in waived test
performance.
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The manufacturer liaison pointed out manufacturers
submit a substantial amount of data showing accuracy and precision, as part of
the 510(k)/PMA process, which was separate from data submitted for waiver.
Moreover, she stated probably 99% of tests in use didn't have a reference
method or reference material. Others disagreed and thought that there were
references for accepted methods.
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Concern was expressed about using the 510(k) process
as proof of accuracy of the test in a waived situation, particularly when
applied to untrained users. Even if studies demonstrated the analytical
performance between trained and untrained users was the same, that didn't mean
performance was clinically the same.
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One member noted the data previously presented
indicated waived tests were being performed by users who were not following the
manufacturer's instructions for test performance. Others agreed that the issue
was not "analytical accuracy" so much as whether it made a difference
to the patient who wanted the test result to be "the truth".
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Postmarket Follow-up
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CLIAC members supported the use of post-approval
surveillance of waived test performance. However, several members expressed
concern about the voluntary nature of follow-up as described in the Draft
Guidance, and the fact that the word "should" was used throughout the
document as opposed to "must." Others did not agree that mandatory
reporting was useful since, for example, there are data suggesting that less
than 10 percent of adverse drug reactions are reported, although by law they
are to be reported to the FDA. The manufacturer liaison indicated there is
already a regulation requiring manufacturers to report any adverse events with
their products to the FDA.
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A suggestion was made to follow the Consumer Products
Safety Commission method of reporting, and to use education and public
information notices requesting the public, physicians, and others who may have
information to use a formal or informal incident reporting system. Perhaps a
widespread educational effort combined with the inclusion of information
(websites, 800 numbers, etc.) in product labeling would increase the reporting
effort.
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Although data on postmarket performance of waived
tests could be obtained from physician office laboratories affiliated with
hospital laboratories, several CLIAC members stressed it is not always possible
to release internal data to the public domain. It was suggested that HHS draft
and attempt to get sponsorship of a statute that would make it possible to make
this data public in a way that it could not be used in liability proceedings in
either state or federal jurisdictions. Access to the data could facilitate
intelligent decision making.
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Dr. Statland noted his concern with postmarket
performance of waived tests, and changes over time as products are used. He
suggested manufacturers should document the performance of their tests after
they have been waived, and the FDA should not rely solely upon pre-market
applications. He concluded by indicating the need for industry, government, and
users of laboratory tests to jointly consider these issues from industry,
public health, and patient perspectives.
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Other Issues
|
Concern was expressed regarding the issue of balancing
access with protection/quality. There was some agreement that this issue would
continue to arise, and the Committee should keep it in mind as they consider
the criteria for waiver.
|
An inquiry was posed as to whether the Draft Guidance
is a working document already in use.
Dr. Gutman responded that it was not currently being used, as it was a work in
progress. He said currently the only criteria for waiver approval are the
provisions in FDAMA, and pointed out there are a variety of complicated legal,
scientific, medical, and regulatory issues which must be resolved before the
Draft Guidance can be implemented.
|
Since the next official meeting of the CLIAC will not
be convened until May 2001 the Committee agreed the Waiver Workgroup,
previously organized at the September 2000 CLIAC meeting, should meet to review
the FDA Draft Waiver Guidance in greater detail. The Waiver Workgroup could
identify substantive issues, and possibly the CLIAC could meet via conference
call to have an opportunity to hear the Workgroup report, and respond
officially before the close of the comment period. (Note: Since it was
subsequently determined the comment period for the Draft Waiver Guidance would
end on May 30, 2001, the Workgroup report will be presented for CLIAC's
discussion and recommendations at the May meeting on that date.)
|
After concluding the waiver discussion, the CLIAC made
the following recommendations pertaining to the FDA Draft Guidance, and noted
that additional recommendations would be forthcoming following the Waiver
Workgroup meeting.
-
Use the words "accuracy," "precision," and
"comparability" appropriately. "Accuracy" should be
considered through the FDA 510(k)/PMA review process, and
"comparability" should be used specifically in discussing the studies
comparing trained and untrained user performance.
-
In the QC section of the Draft Guidance, change the word "should" to
"must," and state "When QC is required, the following principles
apply..."
-
To document the ability of an untrained user to follow the package insert and
perform the test properly, the manufacturer must test the ability of the user
to understand quality control and test patient samples.
-
Waiver studies should include a representative sample of intended users (e.g.
nurses) to provide a valid comparison of comparability between trained users
and users untrained in laboratory practice.
|
In addition, the CLIAC considered two other proposed
motions and decided not to include them as recommendations. The first was that
Section 6 of the FDA Draft Guidance, "Voluntary Safeguard for Waived
Tests," be made a separate document, since it is voluntary. Some members
also noted the safeguards would be appropriate for all tests, and should not be
limited to waived tests. Dr. Gutman felt strongly this section should remain in
the guidance document, explaining that if contained in a separate document, an
important part of the waiver process could be missed. Many CLIAC members agreed
that users of the document would be more inclined to accept consolidated
concepts than to have two documents containing criteria for waiver approval.
The second motion proposed, but not recommended, by CLIAC was a suggestion that
there be some type of oversight of waived laboratories, given that essentially
75% of all laboratories are now unregulated, with 50% of those having problems
with of testing. It was mentioned that since additional information on waived
laboratory performance would be presented at the May 2001 CLIAC meeting, this
motion should be deferred until after the May meeting.
|
Public Comments (Addenda K-N)
|
Joeline Davidson
American Society for Clinical Laboratory Science (ASCLS)
Ms. Joeline Davidson, ASCLS representative, presented several comments on the
FDA Draft Waiver Guidance [Addendum K]. In addition, she said ASCLS is
continuing to study the document and planned to make written comments during
the comment period.
|
Robert Bray, Ph.D.
Professor, Emory University
President-Elect, American Society for Histocompatibility and Immunogenetics
(ASHI)
Dr. Robert Bray indicated he was representing ASHI and the Histocompatibility
Committee at the United Network of Organ Sharing. In making his comment, Dr.
Bray requested that at a future meeting, the CLIAC consider an issue specific
to the CLIA requirements for histocompatibility testing related to solid organ
transplantation [Addendum L].
|
Committee Discussion
|
A CLIAC member said this was an appropriate issue for
CLIAC to consider, and if it was to be addressed at a future meeting, ASHI and
their colleagues would have time to gather information for presentation to
CLIAC. ASHI could present data on the success rates for liver and heart
transplants, including information on transplants with HLA-matched
histocompatibility donors and recipients versus those that were not. Dr. Bray
acknowledged it was a complicated issue, not just in the HLA testing but in the
pre-sensitization, even when a patient has antibodies, it may be preferable to
administer drugs and perform the transplant. The data would be helpful because
in many cases these people would use more blood products post-transplant, and
they have a high incidence of needing re-transplantation as well.
|
A CLIAC member suggested it would be useful to hear
from other organizations, as well as HHS, concerning organ allocation. This
member was concerned that it would take substantial time for the CLIAC to
consider this issue in its entirety, and noted it is a topic which might need
the formation of a Workgroup to focus the issues before bringing the topic to
CLIAC for discussion. Dr. Merlin requested that CDC determine the best way to
develop the issue for CLIAC discussion.
|
Joel Slomoff
Consultant, Hemocue
Mr. Joel Slomoff noted that Hemocue had obtained waiver approval, and stressed
waiver is a privilege not a right. He briefly discussed data provided to the
FDA as part of the 510(k) clearance or waiver approval processes, and suggested
such data be provided to the public when a test system is cleared or approved
for waiver. This information is currently available to the public through the
Freedom of Information Act. By automatically releasing these data, the public
would have an opportunity to comment on or evaluate the data in a timely
manner.
|
Robin Weiner
Vice President
Clinical and Regulatory Affairs
Quidel Corporation
Ms. Robin Weiner, of the Quidel Corporation, expressed several concerns
regarding waiver. [Addendum M]. She stressed that no data had been presented to
show that lack of compliance with QC requirements for waived tests affects
patient outcome. Therefore, she noted the need to determine the effect of not
performing QC testing on patient results and patient outcomes. She also
suggested the need for data on whether moderate complexity laboratories follow
manufacturer's instructions.
|
Committee Discussion
|
A CLIAC member stated the FDA clearance process and
the CLIA regulations are irrevocably intertwined and can not be separated.
While CLIA does not regulate manufacturers, those who advise the program should
consider related issues as they provide advice to HHS. Dr. Merlin clarified the
purpose of CLIAC is to advise HHS on matters pertaining to the quality of
laboratory testing, which does include the quality of testing devices and the
waiver process.
|
Alan Cohen
Editor, Physician Office Laboratory News
Mr. Alan Cohen asked for clarification on whether the FDA Draft Guidance was
currently being used as a mechanism to obtain CLIA waiver using valid
scientific evidence. Mr. Cohen said he'd been told previously that the criteria
used in the draft were the ones used to approve the two new influenza tests
[Addendum N]. He also noted the readers of Physician Office Laboratory News
follow the CLIAC meetings and the issues discussed, and distributed copies of
the latest edition which included an article on CLIAC.
|
Committee Discussion
|
Dr. Gutman responded that waiver decisions are based
on scientific principles, and the FDA is considering a more expansive set of
criteria for approval than those in the 1995 proposed rule. He said the Draft
Guidance was derived from the FDA review of products since the August 2000
meeting. He stressed the Draft Guidance is a non-binding document, and there
are other potential paths to waiver approval.
|
Quality Institute
|
Joe Boone, Ph.D.
Assistant Director for Science
DLS, PHPPO, CDC
Dr. Joe Boone introduced the concept of a Quality Institute to focus on the
future of laboratory testing. Dr. Robert Martin noted that beginning in the
early 1980s, CDC hosted a number of Critical Institutes to address major issues
associated with laboratory testing. He suggested the timing was right to begin
to address some of the issues that would arise over the course of the coming
three to five years. He stressed due to rapidly changing technology and
science, there is a need to reconsider the optimal methods to ensure that
quality testing is available to the public and the clinical community. Dr.
Martin added HHS has been working with CLIA since 1967, and while it is
unlikely there will be a change completely away from a regulatory model, it
would be appropriate, in collaboration with professional organizations and
manufacturers, to consider how much regulation is necessary, and alternative
mechanisms to assure quality testing.
|
Committee Discussion
|
The Committee was in favor of convening the proposed
Quality Institute and made the following suggestions:
|
-
The Institute include significant representation by laboratorians, consumers,
users of laboratory testing, manufacturers, health insurance industry, legal
community, members of the research community and nursing community, clinical
laboratory and medical school educators, and special populations (e.g.,
military, Veteran's Administration, under-served populations such as Native
Americans).
-
The format for the Institute should be one that facilitates problem solving and
focus on the long-term, best interest of the public. It should not be a forum
for position papers, or one that encourages participation based on elected,
vested, or corporate interests.
-
Individuals are changing dramatically in terms of their own sense of
responsibility for health care. The public now uses the Internet extensively,
and is clearly interested in health information and its reliability. Perhaps
there could be a specific educational component aimed toward the public
regarding basic laboratory issues (e.g., error, specificity, sensitivity and
legal issues).
-
Because access to laboratory tests is changing, the Institute should share
information regarding available tests, their quality, and where testing may be
obtained; how to work with industry to ensure quality performance; and how
laboratory information should be shared with providers and the public.
-
Attention should be paid to evaluation of laboratory performance, using
mechanisms such as postmarket surveillance, proficiency testing, etc.
-
Focus should be on a program of active data gathering concerning problems with
laboratory tests and their results, with some emphasis on the sources of this
information (e.g., consumers, test performers, test certifiers).
-
The Institute should consider mechanisms for assessing the competency of those
who perform testing.
-
The Quality Institute should be an on-going process, not just a one-time
meeting. It was suggested strategies be considered to garner financial support
to sustain the Quality Institute effort.
|
Secretary's Advisory Committee on
Genetic Testing (SACGT) Meeting Report (Addendum O)
|
Patricia Charache, M.D.
Professor of Pathology and Medical Oncology
Johns Hopkins Medical Institute
Dr. Patricia Charache reported on the recent SACGT activities [Addendum O],
including a summary of the November 2-3, 2000, SACGT meeting; revisions to the
previously proposed two-scrutiny level algorithm for reviewing genetic tests;
progress in areas of Institutional Review Board (IRB) approval and informed
consent, data elements and data collection, rare disease and low-volume tests,
access to testing, and education of health care providers and the public; and
the former HHS Secretary, Dr. Donna Shalala's, response to SACGT regarding the
oversight of genetic testing by HHS agencies, i.e., HCFA, FDA, and CDC. Dr.
Charache pointed out there were interfaces and overlapping interests between
CLIAC and SACGT, and because of its expertise in laboratory practice, the CLIAC
should continue to contribute to the SACGT discussions.
|
Committee Discussion
|
Several Committee members commented the revised
scrutiny model was an improvement over the previous one, however, there were
additional considerations and problems in applying this model to actual tests.
The Committee members expressed the following concerns:
|
-
The terms "disease prevalence" and "incidence" were not
clearly defined, and the cut-off values were confusing and inconsistent with
each other.
-
It was not likely the same scrutiny level could be applied to the general
population, since disease prevalence varies among different subpopulations and
ethnic backgrounds.
-
Laboratories should not report test results without clinical validity; however,
the revised model removed considerations for clinical validity as well as
ethical, legal, social issues and primarily relies on disease frequency for
test evaluation.
-
It is difficult to apply the revised model to pharmacogenetic tests or tests
that detect normal genetic variations.
-
It would be necessary to assess the practicality and the cost of implementing
the proposed test review mechanism. One member commented increased funding
should be considered not only for FDA but also for the laboratory community to
support this effort.
|
Dr. Charache responded that the Access Working Group
of the SACGT had been addressing cost issues, as well as access to testing in
minority populations. She also pointed out surveillance of scrutiny level I
tests had implications for all laboratory tests, not just genetic tests. One
member suggested the proposed Quality Institute assess both the current
practice of genetic testing and the impact of technology on test development in
the near future.
|
Dr. Steve Gutman, commented the FDA is using a gradual
approach in establishing its oversight of genetic testing. He noted currently,
the FDA is making progress in certain areas, such as establishing requirements
and a database for registering genetics testing laboratories, initiating
round-table discussions on the test classification system, and further
evaluation of several novel approaches in test classification. He stressed the
FDA is trying to develop user-friendly mechanisms that will not inhibit access
to testing or technology advancement.
|
CDC Genetic Testing
Activities/Introduction to Genetics Workgroup/CLIAC Genetics Workgroup
Report/CLIAC Discussion Regarding Genetic Testing (Addenda P-R)
|
Dr. Joe Boone, Assistant Director for Science, DLS,
PHPPO, CDC, briefly described some of the ongoing genetic projects at the CDC
[Addendum P]. He then outlined the formation and purpose of the CLIAC Genetics
Workgroup, the need to move forward in establishing specific requirements for
genetic testing, and the expectations and charge to the Workgroup.
|
Dr. Lawrence Silverman, CLIAC Genetics Workgroup
Chair, reported on the meeting of December 7-8, 2000 [Addendum Q]. He indicated
the purpose of the meeting was to review public comments received to the Notice
of Intent published in the Federal Register on
May 3, 2000, and to evaluate the proposed revisions to the CLIA regulations to
include specific requirements for genetic testing previously recommended by the
CLIAC. He summarized the Workgroup recommendations on definitions of genetic
tests, the laboratory role in documenting clinical validity, the person
authorized to order a genetic test, informed consent, confidentiality, genetic
counseling and consultation, and issues related to specific phases of genetic
testing. He stressed it will be crucial to determine whether acquired or
somatic mutation testing should be included in the genetics specialty,
considering the view that genetic testing consists primarily of tests for
heritable mutations. He also pointed out many molecular testing laboratories
perform tests for both acquired and heritable conditions, which have similar
considerations for the analytical phase but different considerations for the
pre- and post-analytical phases. Finally, he noted many recommendations made
for genetic tests could have implications for other testing specialties.
|
Committee Discussion
|
Dr. Boone guided the Committee discussion with slides
summarizing the Workgroup recommendations into a series of discussion topics:
1) definitions and subspecialties of genetic testing; 2) general requirements
including clinical validity, person authorized to order a genetic test,
confidentiality, informed consent, and re-use of tested specimens; and 3)
requirements for specific testing phases [Addendum R]. He asked the Committee
to comment on the Workgroup recommendations and provide additional input on
each specific issue. The Committee reviewed each recommendation of the
Workgroup, and generally supported the recommendations with the additions or
modifications discussed below. The following summarizes the topics and issues
that received specific comments and suggestions from the CLIAC.
|
Definitions and Subspecialties of Genetic Testing
|
Regarding the proposed subspecialty of biochemical
genetics, one member questioned how measuring normal proteins would differ from
measuring protein products of genetic variants.
Dr. Silverman pointed out the definition was intended to include tests for
proteins associated with specific genetic disorders, such as some of the tests
used for newborn screening, and the purpose of the test would be important in
making the distinction. Several members expressed concern about how proteomic
analyses, when available clinically, should be placed under the proposed
genetic testing specialty. One member indicated this might be an important
issue in defining personnel qualifications related to board certification
requirements. For example, the definition used by the American Board of Medical
Genetics for its biochemical genetics certification examination is different
from this proposed definition.
|
One member indicated requirements for pharmacogenetic
tests might be challenging to establish because it could be difficult to
determine the strength of genetic influence on a particular analyte. Another
member commented some of these tests might be submitted to the FDA for waiver
approval during the process of the genetic test rulemaking. Several members
concurred with this comment and suggested consideration be given to hand-held
chip devices, which might be developed in the near future for physicians to
assist in prescribing individualized medicine, instead of for use in genetic
testing laboratories. Dr. Silverman commented when pharmacogenetic tests are
performed for patient care, a CLIA certificate is required and the pre- and
post-analytical issues related to these tests should be addressed.
|
Several members felt specific examples or lists of
tests should be provided under each subspecialty, i.e., molecular genetics,
cytogenetics, and biochemical genetics. One member suggested tests currently
performed in immunohistochemistry and general chemistry laboratories be
excluded from the genetics specialty. Dr. Boone responded the proposed
framework was one of several options the Workgroup discussed, and it would be
necessary to obtain consultation from professional organizations to define the
types of tests to be included in each subspecialty. One member commented the
intent was not to exclude technology but to stress that genetic tests are
currently covered under CLIA and not every test requires expanded oversight.
Dr. Merlin summarized the discussion by saying the Committee agreed with
establishing the three subspecialties under the specialty of genetics, and
recommended caution be used in determining the tests to be included or excluded
from each subspecialty.
|
Documentation of Clinical Validity
|
Several members expressed concern about the laboratory
role in validating the methodology selected for a test, because laboratories
usually adopt tests that have been developed elsewhere with slight or no
modifications. Dr. Boone clarified under CLIA, the laboratory director is
responsible for selecting test methods that provide the quality of results
required for patient care; however, there is no specific requirement for
establishing clinical validity, and laboratories may not be consistently
documenting clinical validity. It was suggested laboratories verify test
performance specifications as documented in literature references or by test
developers, and demonstrate the test results are comparable for the same
patient populations.
|
Person Authorized to Order a Genetic Test
|
Several members expressed concern about the
self-referral issue and felt while it is important not to obviate people's
opportunity to make their own healthcare decisions, the laboratory director
should decide which tests to offer and whether additional assistance associated
with self-referral would be needed. It was also suggested the term
"patient self-ordering" be used instead of "self-referral,"
which has a legal meaning related to Medicare reimbursement.
|
Informed Consent
|
Several members expressed concern about the laboratory
burden associated with requiring informed consent. One member indicated that
requiring informed consent for cancer-related tests would be difficult. Another
member inquired whether tests, such as hemoglobin electrophoresis, performed in
non-genetic laboratories, would require informed consent for diagnosis of
heritable conditions. Some members noted obtaining informed consent when
patients self-order tests might be problematic, particularly if testing could
be ordered over the Internet. One member suggested the laboratory have a system
for self-ordering, perhaps using a separate form, if the laboratory is allowed
to accept such ordering. It was also suggested some tests might need to be
screened by health care providers. Dr. Silverman pointed out the intent was not
to create unmanageable laboratory requirements, but to require the appropriate
level of informed consent. It was also clarified that the laboratory should be
available to assist in determining the appropriate level of informed consent.
|
Re-use of Tested Specimens
|
One member pointed out specimen re-use should be an
overall laboratory issue and not be restricted to genetic tests, and suggested
specimen re-use be included in the general CLIA requirements. Another member
indicated the genetics community has emphasized the need to
re-use specimens for quality assurance (QA) and QC purposes through SACGT and
other discussions, and suggested requirements for specimen re-use be included
within the genetics specialty to prevent conflicting policies. It was suggested
the recommendation "If subsequently desired for research testing under
IRB, then new consent is needed" be deleted, since CLIA does not apply to
research testing.
|
Test Requisition and Clinical Information
|
One member raised concern about the practicality of
the proposed components of the test requisition, since laboratories do not
always receive all the required information. Another member commented that
while about 70% of laboratories performing genetic testing currently require
information such as age and ethnicity, fewer than 10% of the laboratories are
enforcing the requirement, and suggested the following requirement be added:
"Reports should not be sent out until appropriate clinical information
critical for interpreting test results is received by the laboratory." One
member commented the suggested requirement might be an attempt to correct
operational problems by regulation, and it might be more appropriate to rely on
professional societies and accrediting agencies to develop guidelines to
improve collection of information required by laboratories.
|
Personnel Qualifications and Responsibilities
|
It was noted that determining appropriate personnel
qualifications would depend on which tests were included in the genetics
specialty. Dr. Boone acknowledged the need to assess the credentials currently
possessed by laboratory personnel and the impact of the proposed qualification
requirements on these individuals. Several members suggested the requirement
for the technical supervisor to "be certified in medical genetics" be
modified to "certified in an appropriate medical genetic
subspecialty."
|
Genetic Counseling
|
One member pointed out patients might need to be
referred to medical services other than genetic counseling. Another member
suggested "when appropriate" be added to the second recommendation,
i.e., "laboratories should facilitate access to genetic services when
appropriate." In addition, the member suggested deleting the third and
fourth recommendations, i.e., "laboratory should not be required to have a
documented relationship with genetic counseling resources because the
laboratory cannot direct patient care," and "laboratory should be
required to recommend genetic counseling for family members when
indicated." One member suggested the third recommendation be reworded to
"the laboratory should not be required to provide genetic
counseling." Dr. Silverman clarified the fourth recommendation meant the
laboratory should recommend genetic counseling to health care providers, not to
the patient or family members directly.
|
Proficiency Testing (PT)
|
One member felt the two-tiered system (regular PT and
inter-laboratory comparison programs) recommended by the Workgroup would be
difficult to develop or carry out, and urged the CDC to continue its vigorous
efforts to enhance QC programs and to develop QC materials. Another member
expressed concern about research laboratories performing patient testing for
rare diseases as a courtesy to their colleagues and suggested professional
societies would be helpful in providing advice in this area. Dr. Boone noted
the recommendation "The requirements should not be less stringent for low
volume tests and rare disease testing, but alternative PT may be needed"
was an attempt to address this issue.
|
Result Reporting
|
One member suggested "date of birth" be
required for all laboratory tests, not just genetic tests. With regard to
qualifications of the individuals signing the report, several members suggested
"highest qualification" be changed to "appropriate
qualification" or "equivalent certification."
|
Retention of Records
|
It was indicated record retention requirements might
depend on the type of testing performed; for example, records of newborn
screening testing might need to be retained for a timeframe longer than 10
years or for 25 years as required by some States. One member suggested
requirements for retention of genetic testing records be comparable to the
requirement for retention of pathology reports, which must be retained for at
least 10 years under the current CLIA requirements. It was also clarified that
electronic records are allowed and must be retained for the same timeframe as
hard copies.
|
Retention of Specimens
|
One member inquired how patient refusal for specimen
re-use should affect retention of the specimen. Dr. Boone clarified the
laboratory might need to perform confirmatory tests and should not discard the
specimen prematurely. Another member suggested the specimen retention policy
should be different from the requirements for re-use of tested specimens for QC
purposes. The Committee supported using the Notice of Proposed Rulemaking to
solicit public comments on this issue.
|
Summary and Next Steps
|
In summary, the Committee reviewed the recommendations
by the CLIAC Genetics Workgroup and generally endorsed the proposed
requirements for genetic testing, with comments provided (as discussed above)
for suggested revisions to the Workgroup recommendations. The Committee
recommended moving forward with development of a Notice of Proposed Rulemaking
to contain the CLIAC suggested requirements for genetic testing under CLIA.
|
Dr. Martin indicated the next step would be to begin
developing the proposed rule for genetic testing, based on the revised CLIAC
recommendations and noted there will be additional opportunities for CLIAC
involvement as the proposed rule is developed. In addition,
Dr. Charache will represent the CLIAC and present the genetic testing
recommendations in her report at the next SACGT meeting.
|
Closing Remarks
|
With no further business, Dr. Merlin officially
adjourned the February 2001 CLIAC meeting.
|
Date for the next CLIAC meeting: May 30-31, 2001
|
I certify that this summary report of the February
7-8, 2001, meeting of the Clinical Laboratory Improvement Advisory Committee is
an accurate and correct representation of the meeting:
|
| /S/ Toby L. Merlin, M.D., CLIAC Chair |