Clinial Laboratory Improvement Advisory Committee (CLIAC)Summary Report - May 1996
U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Clinical Laboratory Improvement Advisory Committee May 29-30, 1996
Table of Contents
I. Record of Attendance
II. Welcome and Announcements
III. Presentations and Committee Discussion
CLIA Update
Centers for Disease Control and Prevention
Health Care Financing Administration
Quality Control Issues
Background
Introduction
Evolution of QC Practices in Healthcare Laboratories
Point-of-Care Testing
QC Concepts for Revision of Regulations
Consolidation of Regulations on PTM, QC, and QA
Revision of Minimum Standards for QC
Issues for Committee Discussion
Committee Discussion
Additional Committee Concerns
IV.Public Comments
V.Concluding Remarks
VI.The Addenda
Record of Attendance
The Clinical Laboratory Improvement Advisory Committee (CLIAC) met at the
Centers for Disease Control and Prevention (CDC), Auditorium B, in Atlanta,
Georgia, on May 29-30, 1996. There were approximately 114 people in attendance.
The Committee members, CDC staff and presenters in attendance are listed below:
Committee Members Ex Officio Members
Dr. J. Scott Abercrombie Dr. Carlyn Collins, CDC
Dr. David Baines Dr. Steve Gutman, FDA
Dr. Regina Benjamin Ms. Judith Yost, HCFA
Ms. Michele Best
Dr. Thomas Bonfiglio
Dr. Ronald Cada
Dr. Susanne Gollin
Dr. Verlin Janzen Executive Secretary
Ms. Sandra Johnson Dr. Edward Baker
Dr. J. Stephen Kroger
Dr. Bereneice Madison
Ms. Deborah McHugh Liaison Representatives
Dr. Wendell O'Neal. Fred Lasky (HIMA)
Dr. Glenda Price
Dr. Sharon Radford
Dr. Patricia Saigo
Dr. Morton Schwartz
Dr. Ulder Tillman
Centers for Disease Control and Prevention
Ms. Nancy Anderson
Ms. Rosemary Bakes-Martin
Ms. Carol Bigelow
Dr. Joe Boone
Ms. Cheryl Coble
Ms. Carol Cook
Ms. Crystal Frazier
Ms. Sharon Granade
Dr. Tom Hearn
Dr. Edwin Holmes
Dr. John Krolak
Dr. Anne O'Connor
Dr. John C. Ridderhof
Dr. Eunice Rosner
Dr. Shahram Shahangian
Mr. Darshan Singh
Mr. Gregory Smothers
Ms. Julie Wasil
Ms. Rhonda Whalen
Clinical Laboratory 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, 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 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.
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 law,
the reader should not infer that all of the advisory committee's
recommendations will be automatically accepted and acted upon by the
Secretary.
Welcome and Announcements
The CLIAC meeting was called to order and committee members were welcomed by
Chairman Dr. Morton Schwartz. The committee members made self-introductions
and disclosure statements of their relevant financial interests as they relate to any
topics to be discussed during the CLIAC meeting. Dr. Schwartz then stated the role
and function of CLIAC.
Presentations and Committee Discussion
Clinical Laboratory Improvement Amendments (CLIA) Update/CDC
Dr. Carlyn Collins, Director of the Division of Laboratory Systems, reviewed the
status of three regulations in progress: (1) the final rule for criteria for waiver; (2)
the final rule that extends the phase-in period for the quality control (QC)
requirement applicable to moderate complexity testing which expires September 1,
1996; and (3) the regulatory reform final regulation which simplifies the CLIA
regulations pertaining to proficiency testing (PT), inspections, and accreditation
and exemption. Because these regulations have been given high priority and may
be published by the end of the year, the publication of the final, final regulations
has been delayed. Responding to a CLIAC member, Dr. Collins noted that the
requirements for APT (accurate and precise technology) testing will be considered
as we develop the final, final regulations.
Dr. Collins also reported that the U.S. Court of Appeals for the District of Columbia
has reversed the district court's decision in the lawsuit of Consumer Federation of
America and Public Citizen vs. the Department of Health and Human Services
(HHS). The Court of Appeals ruled that:
The CLIA regulations for categorizing tests and personnel qualifications were
established in accordance with the law. The higher court agreed with the
Department's position that the current regulation takes risk of harm into
account and that test categorization based on the potential consequences of
erroneous results would be too subjective and unworkable.
HHS must publish an official explanation justifying the current cytology PT
regulations allowing individuals to examine PT slides at a rate lower than
normal workload rate. In the mean time, the current cytology PT regulations
remain in effect.
Dr. Collins (and later Dr. Ed Baker, Director of the Public Health Practice Program
Office, CDC, and Executive Secretary of CLIAC ) noted that HHS has received
considerable correspondence on genetics testing. CDC is participating in a genetics
task force established by the National Institutes of Health and Dr. Collins said that
CLIAC advice would be sought in addressing some of the genetics testing issues.
Dr. Schwartz suggested that CLIAC should provide input on DNA and RNA testing
but not the ethical and legal aspects of genetics testing.
CLIA Update/Health Care Financing Administration (HCFA)Addendum A
Ms. Judith Yost, Director of the Division of Laboratory, presented a status report on
CLIA implementation. She summarized CLIA laboratory enrollment data by
certificate type and by laboratory type, enrollment data from accreditation
organizations, and noted the category of CLIA-exempt laboratories.
Ms. Yost then reviewed data from surveys. She said that HCFA surveys more than
34,000 laboratories every two years [approximately two-thirds are physicians office
laboratories (POLs)] and that second cycle surveys of about 10,700 laboratories
have been completed. She noted a large increase in the percentage of laboratories
with no deficiencies and a decrease in the percentage of laboratories with condition
level deficiencies. The most frequent condition level deficiency continues to be
failure to enroll in a PT program. Ms. Yost reported that POLs have shown
dramatic improvement on surveys, which she attributed to HCFA's educational
approach to inspections.
Ms. Yost reported that about 1,700 laboratories have participated in the Alternate
Quality Assessment Survey, a paper self-survey for laboratories that have no
deficiencies in their first inspection and that demonstrate satisfactory PT
performance for one year. HCFA has recently implemented an outcome-oriented,
on-site inspection process which it considers to be more efficient and more effective
than earlier surveys. The new inspection process focuses on how the laboratory
identifies, corrects, and prevents the recurrence of problems.
One committee member expressed surprise that 30% of the laboratories surveyed by
HCFA for the second time have no deficiencies. He reported that the Commission
on Office Laboratory Accreditation has experienced an increase in laboratories with
no deficiencies, but that the numbers were lower than HCFA figures.
QC Issues
Background
Introduction Addendum B
Ms. Rosemary Bakes-Martin briefly reviewed issues discussed at previous CLIAC
meetings concerning the revision of the CLIA QC requirements to address new
technology. Previous discussions centered on the phase-in of the QC requirements
for unmodified, moderate complexity testing, the manufacturer's role in QC,
whether traditional QC concepts are applicable to new technology, the
establishment of a core set of QC requirements, and simplification of the regulatory
structure and language. Ms. Bakes-Martin then introduced the speakers who
would give background information for discussion of QC issues.
Evolution of QC Practices in Health Care Laboratories Addendum C
James Westgard, Ph.D., reviewed the current status of laboratory and statistical
QC practices and noted that the Food and Drug Administration CLIA QC clearance
process has not been implemented due to budget constraints. He observed that
current QC practices are based on QC rules used ten years ago and are arbitrary
because we have not defined the quality we want to achieve. Reviewing the
evolution of laboratory statistical QC practices, Dr. Westgard noted that the
development of QC systems significantly lags behind the development of test
systems and commented that it is impossible to design control procedures to achieve
a zero error rate. He said that historically the laboratory focus shifts between
quality and cost control, and that currently the emphasis is on cost control.
Because of the focus on cost control, the laboratory employment of skilled personnel,
who could detect many errors, has decreased. In addition, laboratories have not
defined the amount of error they are willing to tolerate; thus they can't define the
level of quality they want to achieve.
Dr. Westgard stated that laboratories currently have the tools to design a quality
monitoring system and suggested that laboratories use the PT requirements
(criteria for acceptable performance) as a benchmark for defining test quality. In
establishing QC procedures, he noted that laboratorians must consider the stability
of the testing process and the frequency of problems encountered using the test
system. Because the employment of skilled personnel has decreased, Dr. Westgard
stressed that instrument design should incorporate quality systems to assure that
test results meet quality requirements.
In the discussion that followed Dr. Westgard's presentation, Dr. Schwartz noted
that the laboratory is responsible for the analytical phase of the total testing
process and asked for input on developing quality requirements. Dr. Westgard
suggested that the development of requirements should be data driven. He also
noted that electronic controls only monitor the instrument and indicated that
traditional controls may be the most efficient way to monitor a multi-step testing
process. Alternatively, he said that for unit test measurement devices, monitoring
those steps in the test system's testing process which could cause enough variation
in the test result to impact the diagnosis or treatment might be appropriate.
Referring to the impossibility of designing control procedures to detect a zero error
rate, Dr. Schwartz asked Dr. Westgard to comment on acceptable error rates.
Dr. Westgard suggested that a "worst case" error rate of 1 in 1,000 might be
acceptable, but 1 in 10,000 would be better. One committee member said that the
acceptable defect rate should be defined in the context of the use of the test result.
Dr. Westgard reemphasized that defining and monitoring quality is important in
spite of economic constraints. Formerly we depended on experienced laboratory
personnel to monitor quality; now we depend on monitoring processes. In addition,
because of the changes in health care practices, Dr. Westgard said that a standard
process should be developed for monitoring quality that guides people, allows for
different input sources, can be managed quantitatively, and can be passed on to
others.
Point-of-Care (POC)Testing Addendum D
Barbara Goldsmith, Ph.D., discussed the type of technology used for POC testing in
various types of institutions. She described the proposed National Committee for
Clinical Laboratory Standards (NCCLS) guidelines for POC testing and focused on
the QC aspects of the new technology being used in POC testing. The guidelines
were produced as a resource to establish uniformity in POC testing, are oriented
toward non-laboratory trained personnel, and should become an approved NCCLS
standard by January 1997.
Following Dr. Goldsmith's presentation, CLIAC members discussed the following
issues concerning POC testing and the technology used in that testing:
Electronic controls may check the performance of the instrument but not the
operator; operator performance must be adequately controlled.
Whole blood controls and proficiency testing materials are not available for
many instruments.
POC testing in hospitals may differ from POC testing in other environments
(for example, testing personnel training).
Positive screening test results are often confirmed by additional tests.
Negative screening results usually are not confirmed and might cause a
diagnostic error.
Expense associated with POC testing may limit its use.
The definition of test turn-around-time (the starting point and the ending
point) and its impact on patient care need clarification.
Various accrediting agencies have different QC requirements.
QC Concepts for Revision of Regulations Addenda E-G
Ms. Bakes-Martin presented a progress report from the CDC QC Workgroup and
referred CLIAC members to an internal reference document (see addendum E) that
summarizes the results of a literature search on ten pertinent QC topics. The
document served as a resource for developing the following concepts for
consideration in revising the CLIA QC requirements:
Consolidate the regulations on Patient Test Management (PTM), QC, and
Quality Assurance (QA) into one section to be named "Quality Monitoring"
(see addendum F).
QC protocols should consider two issues: potential for error and monitoring
over time (see addendum G).
The analytical phase of the testing process primarily has three potential
sources for error: test system, environment, and operator (see addendum G).
Ms. Bakes-Martin noted that one of the QC issues to be resolved is defining levels of
control and types of controls needed to monitor new technology, specifically POC
testing. Ms. Bakes-Martin stated that traditional QC was designed to monitor all
three components (test system, environment, and operator) and then gave examples
of how each component can be monitored for error using alternative approaches.
She noted that there is less operator intervention in some of the new test systems.
Ms. Bakes-Martin commented that traditional controls would still be important in
evaluating operator performance and in monitoring over time. However, the
current requirement for testing traditional QC during each run of patient samples
may be too restrictive for test systems with internal controls. For test systems
having internal QC monitors, CDC recommended consideration of an approach that
could include running traditional QC a minimum of once per week in order to
monitor the entire analytical phase of the testing process over time.
QC Issues for Committee Discussion Addendum H
Regarding the concepts presented, CDC asked the Committee to consider the
following issues:
Issue #1: Does the reorganization of "Patient Test Management," "Quality
Control," and "Quality Assurance" into one section called "Quality
Monitoring" reflect present day clinical laboratory practice?
Issue #2: Does the CDC proposal for revising the minimum standards for
Quality Control make adequate allowances for new technology?
Issue #3: Does the CDC proposal adequately address the potential for error in
test performance?
Issue #4: Does the CDC proposal adequately address the concept of monitoring
over time to ensure quality?
Committee Discussion
The Committee agreed with the concept of reorganizing PTM, QC, and QA into one
section, but recommended naming the section "Quality Assurance" or "Quality
Systems," instead of "Quality Monitoring." In a lengthy discussion of Issues #2-4,
committee members expressed the following concerns:
Non-traditional (internal) controls may not monitor operator competency.
Changes in operator may need to be monitored.
Non-traditional (internal) controls may require monitoring to ensure their
effectiveness.
PT assists in monitoring quality, but PT samples are not available for many
of the new technology instruments.
For test systems having internal monitors, running traditional QC a
minimum of once per week seems arbitrary. A QC frequency requirement
should be based on data. Clarification is needed as to whether the laboratory
director would be required to determine the frequency of QC testing.
Definitions of traditional controls (liquid materials vs. other options) are
needed.
Traditional QC may not be appropriate for many instruments that have non-
traditional (internal) controls.
Manufacturers may have data to show that non-traditional (internal)
controls adequately monitor the test system, the environment, and the
operator and to suggest whether (or how frequently) traditional controls
should be tested.
For new technology, specific QC requirements for individual test systems
could be incorporated into HCFA surveyor guidelines.
Regulations must be flexible to accommodate changes in technology. The
concept presented appears flexible, but lacks detail.
Definitions of quality, error, and accuracy are needed, as well as a better
understanding of the concept of "monitoring over time."
Operator monitoring could be accomplished through on-going education and
training.
In general, the Committee agreed that the test system, the environment, and the
operator are the main sources of error. Several CLIAC members felt that testing
traditional controls weekly may be sufficient for monitoring, but others felt that
this type of testing would not make adequate allowance for new technology and
noted that options other than testing traditional QC might be used. To allow
flexibility, some members suggested that the frequency of testing controls might be
"as appropriate for technology," rather than "at least once per week." The
committee members, however, wanted additional information before making any
recommendations concerning frequency and type of controls, and asked that specific
data on QC performance be presented at a future CLIAC meeting.
Additional Committee Concerns
One committee member asked about the status of the ASM recommendations on
microbiology QC. Dr. Collins acknowledged that the data presented by ASM
indicated that some revisions may be needed to the QC requirements for
microbiology reagents and said that CDC plans to focus on microbiology QC once
the general QC issues are resolved. Committee members raised additional concerns
about (1) the variation among accreditation agencies' requirements and differences
between accreditation agency requirements and the CLIA requirements, e.g.
frequency of QC testing, and (2) the possible need for reconsideration of laboratory
specialty/subspecialty classification as new technologies develop.
Public Comments Addendum I
1.Frank LaDuca, Ph.D., Vice-President, International Technidyn Corporation,
noted that with POC testing (single use test devices), the entire testing unit is
consumed each time a test is performed. In his opinion, the manufacturer should
be responsible for demonstrating that all potential sources of error except operator
error are monitored. Dr. LaDuca felt encouraged by the CLIAC discussion and said
that he would be willing to share information/data on coagulation instruments.
2.William Moffitt, President and Chief Executive Officer of i-STAT
Corporation, said that no single monitoring system is appropriate for all technology
and that regulations should assure quality rather than requiring a particular QC
system (see addendum I). He suggested that the FDA's Good Manufacturing
Practice (GMP) standards be considered in CLIAC discussions about QC
procedures, noting that "laboratory" could be substituted for "manufacturer" and
the standards would be appropriate regulations for laboratories. Regulations which
parallel the GMP standards would acknowledge the variety of technology and
environment-specific applications and allow manufacturers to develop appropriate
quality systems to be validated by the laboratory director.
Noting the Committee's discomfort with assumptions and opinions, Mr. Moffitt said
that numerous manufacturers have data supporting their alternative quality
systems. He suggested that CLIAC should have manufacturers make presentations
and share data on the newer technologies.
Concluding Remarks
Dr. Schwartz expressed appreciation to CLIAC members whose official terms expire
on June 30, 1996 (Dr. Scott Abercrombie, Ms. Michele Best, Ms. Sandra Johnson,
Dr. Stephen Kroger, and Dr. Wendell O'Neal). He announced that the dates for
upcoming CLIAC meetings will be September 25-26, 1996, and January 8-9, 1997,
and then adjourned the meeting.
I certify that this summary report of the May 29-39, 1996, meeting of the Clinical
Laboratory Improvement Advisory Committee is an accurate and correct
representation of the meeting.
Morton K. Schwartz, Ph.D.
Chairman
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