September 22-23, 2004
Table of Contents
I. Record of Attendance
II. Clinical Laboratory Improvement Advisory Committee -
III. Call to Order and Committee Introductions
IV. Agency Updates
V. Presentations and Committee Discussion
VI. Public Comment
| Record of Attendance
|Committee Members Present
|Dr. David Sundwall, Chair
||Dr. Margaret McGovern
|Ms. Joeline Davidson
||Dr. Dina Mody
|Dr. Kathryn Foucar
||Dr. Valerie Ng
|Ms. Paula Garrott
||Dr. Barbara Robinson-Dunn
|Dr. Peter Gomatos
||Dr. Jared Schwartz
|Dr. Cyril M. (Kim) Hetsko
||Mr. Albert Stahmer
|Dr. Anthony Hui
||Dr. Lou Turner
|Dr. Patrick Keenan
||Dr. Thomas Williams
|Dr. Michael Laposata
||Dr. Jean Amos Wilson
|Committee Members Absent
|Dr. Kimberle Chapin
|Mr. Kevin Kandalaft
Ex Officio Members
Dr. Toby Merlin, CDC
Ms. Daralyn Hassan and Ms. Raelene Perfetto (for Ms. Judith Yost), CMS
Dr. Jean Cooper (for Dr. Steven Gutman), FDA
Liaison Representative - AdvaMed
Ms. Luann Ochs, Roche Diagnostics Corporation
|Centers for Disease Control and Prevention
|Ms. Miriam Alter
||Ms. Wendi Kuhnert
|Ms. Nancy Anderson
||Dr. Harvey Lipman
|Dr. Rex Astles
||Dr. Adam Manasterski
|Ms. Pam Ayers
||Ms. Leslie McDonald
|Ms. Carol Bigelow
||Ms. Diane Ricotta
|Dr. Joe Boone
||Dr. John Ridderhof
|Ms. Diane Bosse
||Dr. Darshan Singh
|Dr. Bin Chen
||Dr. Suzanne Smith
|Ms. Joanne Eissler
||Dr. Susan Snyder
|Ms. Maribeth Gagnon
||Dr. Julie Taylor
|Ms. Sharon Granade
||Ms. Patricia Thomas
|Ms. Lauren Green
||Mr. Howard Thompson
|Dr. Jim Handsfield
||Ms. Pam Thompson
|Dr. Tom Hearn
||Ms. Glennis Westbrook
|Ms. Jerri Holmes
||Ms. Rhonda Whalen
|Dr. Devery Howerton
||Ms. Darlyne Wright
|Department of Health and Human Services
(Agencies other than CDC)
|Ms. Carol Benson (FDA)
||Ms. Daralyn Hassan (CMS)
|Dr. Elliott Cowan (FDA)
||Ms. Raelene Perfetto (CMS)
|In accordance with the provisions of Public Law 92-463, the meeting was open to
the public. Approximately 25 public citizens attended one or both days of the
Clinical Laboratory Improvement Advisory Committee
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.
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
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; 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 also includes 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 DISCLOSURES
Dr. David Sundwall, CLIAC Chair, welcomed the Committee members and called the meeting to order.
He introduced himself as a practicing physician with many years of
experience representing the private sector on issues of public health policy.
He then acknowledged the vast diversity of experience and talent
represented by the CLIAC membership and introduced five new members:
Ms. Joeline D. Davidson, Dr. Patrick A. Keenan, Dr. Dina R. Mody, Dr.
Lou F. Turner and Dr. Thomas L. Williams.
Dr. Robert Martin, Executive Secretary of CLIAC and Director, Division of Laboratory Systems (DLS),
Public Health Practice Program Office (PHPPO), CDC, also welcomed the members
and expressed his appreciation of the Committee.
He acknowledged the Committee's work is critical in providing assistance to
establish the framework of laboratory practice in the
To set the tone for the meeting, Dr. Sundwall shared that there is a growing interest among federal
and state policy makers to address public concern about the quality of
laboratory testing, based on recent incidents reported by the press, by adding
additional regulation through legislation.
He noted the responsibility of CLIAC is to consider the evidence and be well
prepared to counter arguments for additional legislation and regulatory burdens
unless stronger regulations are needed and to advise the Secretary of HHS.
For that reason, Dr. Sundwall announced the focus of the meeting would
be non-regulatory approaches to laboratory improvement.
He then distinguished between minimal requirements included in
regulations and best practices/consensus voluntary standards.
He also addressed the importance of collecting data related to the
implementation and utility of voluntary standards.
Dr. Sundwall explained the requirements and process for public disclosures, including those for
conflict of interest. All members made
self-introductions and financial disclosure statements relevant to the meeting
Food and Drug Administration (FDA)
Status of FDA Waiver Guidance Document
Dr. Jean Cooper, Division Director, Chemistry and Toxicology Devices, Office of In Vitro Diagnostic
Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health
(CDRH), FDA, briefed the Committee on OIVD's involvement in recent events
relative to the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
She informed the members that the waiver guidance document is a high
priority for FDA and input from CLIAC, CDC, CMS and AdvaMed has made the
document more flexible and scientifically grounded.
She briefly highlighted the types of modifications made to the previous waiver
guidance issued by FDA, OIVD's process for developing the current draft waiver
guidance, and the plan to release the draft guidance for external comments by
A member asked when a final rule would be published.
Dr. Cooper stated FDA hopes to have the draft waiver guidance available before
the end of the year for comments, with another year to finalize the guidance.
Subsequently, development of the waiver regulation will require
rulemaking and additional time. In answer
to a question of whether FDA intends to use the final waiver guidance while the
regulation is being developed, Dr. Cooper replied the waiver guidance would be
used as soon as it is finalized.
requested information about FDA's acceptable total allowable error rate for the
proposed studies to support a waiver request.
Dr. Cooper replied there is no specific range or number applicable to all
assays. FDA is striving for a statistical
approach and is encouraging suggestions from CLIAC and others on how to
Ms. Luann Ochs, AdvaMed Liaison to CLIAC, thanked the Committee members and FDA for
incorporating many of AdvaMed's recommendations in the waiver guidance
document, especially the principles of risk analysis and risk assessment.
She asked about FDA's intentions for post-market surveillance.
Dr. Cooper explained post-market surveillance would differ from
traditional surveillance; there will be more of a working relationship between
manufacturers and end-users.Manufacturers
will need to communicate their use of flex studies, risk analysis, and quality
control (QC) information to the end-user.
Dr. Sundwall noted that distributors have expressed an interest in sharing
educational information with their customers and asked Ms. Ochs if distributors
could play a role in this communication process.
She replied that distributors are not part of AdvaMed; each manufacturer should
work with their distributors on ways to improve communication with and
education of the end-user.
Update on Rapid HIV Test Waivers
Dr. Elliot Cowan, Associate Director, Division of Emerging and Transfusion Transmitted Disease,
Office of Blood Research and Review, Center for Biologics Evaluation and
Research, FDA, provided an update on CLIA-waived rapid HIV tests.
He informed the Committee the OraQuick® Rapid HIV-1 Antibody Test name
has changed to OraQuick® ADVANCE Rapid HIV-1/HIV-2 Antibody Test, reflecting
the extension of waived status to include HIV-2 antibody detection.
Additionally, this test has recently received waiver approval for use
with oral fluid specimens. He also noted
the Uni-GoldT Recombigen® HIV test has received waiver approval for capillary
and venous whole blood specimens. Dr.
Cowan compared the sensitivity and specificity of the OraQuick® and Uni-GoldT
test systems and mentioned the sale restrictions FDA has placed on rapid HIV
tests. He concluded by notifying the
Committee of the statistical validation studies being performed and the
possibility of developing an algorithm using multiple rapid HIV tests for
A member requested clarification of "invalid" rapid HIV test results and asked
how frequently invalid results occur. Dr.
Cowan explained that invalid test results occur infrequently and the test
system instructions recommend that invalid tests be repeated.
If problems continue, the customer service representative should be
Dr. Robert Martin mentioned the importance of understanding how to interpret rapid
HIV test results in populations with varying prevalence of disease.
He added that DLS is still heavily involved in CDC's rapid HIV training
efforts and asked Dr. Devery Howerton to elaborate.
Dr. Howerton, Chief, Laboratory Practice Evaluation and Genomics Branch, DLS,
briefed the Committee on CDC's role in training those who provide rapid HIV
testing and counseling primarily in outreach settings, community-based
organizations, and public health centers.
Dr. Cowan then expressed appreciation for CDC's training efforts and support of
rapid HIV testing and applauded the quality assurance (QA) program CDC
developed for their publicly funded sites performing rapid HIV testing.
Several members expressed concern about whether processes are in place
to monitor waived HIV test sales restrictions, to include assuring each testing
site is CLIA-certified and provides a quality assurance program.
Dr. Cowan stated FDA is not involved in these aspects; manufacturers
provide a "customer agreement" in each kit to explain the rapid HIV test
requirements and sales restrictions to the purchaser.
Currently, the agreement relies on the "honor" system for purchaser
compliance; however, states often impose additional requirements for rapid HIV
testing. Referring to CDC's rapid HIV
training efforts, Dr. Martin explained when a federal agency collaborates with
public health clinics or community-based organizations, it has a responsibility
to convey information about the test system, its intended use, important
procedural criteria, and limitations.
A member inquired whether public health disease reporting has been impacted by
the use of waived rapid HIV tests in public health clinics/community-based
organizations and whether states have data pertaining to the number of tests
performed versus the number of HIV cases reported.
Dr. Tom Hearn, Deputy Director, DLS, PHPPO, CDC, commented CDC has cooperative agreements to collect data during the
rollout of waived rapid HIV testing at CDC-funded organizations and suggested a
future report on those data.
A member commended FDA and CDC on the successful implementation of the waived
rapid HIV tests and the increased percentage of individuals tested who receive
their test results. One study showed 99%
of individuals received rapid test results versus 60% of individuals with
standard tests. The member also pointed
out that during the next decade, as data are collected, it will be of interest
to determine the impact on patients receiving care and disease management
following detection via rapid HIV testing.
Centers for Medicare & Medicaid Services (CMS)
CLIA Statistics, QC for the Future Meeting
Addenda C, D
In the absence of Ms. Judy Yost, Director, Division of Laboratory Services (DLS), CMS,
Ms. Rhonda Whalen, Chief, Laboratory Practice Standards Branch, DLS,
PHPPO, CDC, gave her presentation. Ms.
Whalen reviewed the CLIA statistics as of August 2004 and provided an update on
CMS's CLIA activities. This included
information about the revised surveyor guidelines, published
January 12, 2004, and posted on the CMS CLIA website (www.cms.hhs.gov/clia/).
She also mentioned the CMS surveyor training in November 2004, and the
availability of four CLIA brochures explaining the quality system regulation
published January 24, 2003.
Ms. Whalen cited concerns raised about the accreditation process and noted CMS will be meeting
November 16, 2004, with state, federal, and private accrediting officials and
state regulators to discuss improvements to the CLIA accreditation and
Ms. Whalen then reviewed the status of the notice of proposed rule making (NPRM) for genetic testing.
She noted CMS and CDC are clarifying some issues before the rule begins
the clearance process and reminded the Committee of the extensive process of
rulemaking. Ms. Whalen summarized
current and future QC issues faced by testing facilities and announced CMS is
planning a workshop entitled "QC for the Future - Equivalent Quality Control
Workshop" on March 18, 2005,
in conjunction with the NCCLS Leadership Conference (Addendum E).
CMS Certificate of Waiver (COW) Project Update
Ms. Raelene Perfetto, Medical Technologist, DLS, CMS, updated the Committee on the COW project.
She emphasized data presented at the February 2004 CLIAC meeting were
preliminary data from CMS visits to COW facilities during 2002 and
2003. CMS has since validated the 2002
data and is in the process of evaluating the 2003 data.
Some of the validated data differ from the preliminary data but most
remains the same. In particular,
preliminary, unvalidated data showed 2% of the surveyed COW laboratories
operated under immediate jeopardy (IJ) conditions, posing imminent and serious
risk to human health, but revised data showed only two cases of IJ.
She reported there were several reasons why some preliminary data had to
be revised during the validation process.
These included the use of a new data entry system unfamiliar to some of the
surveyors, data entry errors, and lag time from survey date until the time of
data compilation. In addition, some
surveyors initially interpreted testing beyond the scope of the laboratory's
certificate as an IJ situation without contacting CMS to determine the validity
of the IJ citation. Ms. Perfetto informed
the Committee of CMS corrective actions, e.g., additional surveyor training,
clarification of the definition of IJ, and the requirement to report and
confirm with the regional and central offices before entering IJ information
into the database. Databases have also
been redesigned to prevent data entry for some survey questions until
confirmation of the information is obtained from CMS.
Ms. Perfetto said CMS is currently completing validation of the 2003 COW data and evaluating data
from the 2004 surveys. She mentioned that
a proposal to continue COW surveys indefinitely has been submitted to CMS
management and emphasized data continue to reflect quality problems in COW
CMS COW Project, Fiscal Year (FY) 2002
Ms. Daralyn Hassan, Medical Technologist, DLS, CMS, presented an overview of the
results and compliance issues from the CMS 2002 COW Project.
She noted there were persistent regulatory issues with facilities either
not having or not following manufacturer instructions, and there is an ongoing
need for education/training on CLIA and laboratory procedures for waived
testing personnel.She reiterated a
significant number of COW facilities fail to follow manufacturer's
instructions, and there are no data available to determine whether tests
perform as intended when instructions are not followed.
However, Ms. Hassan reported 96% of COW facilities revisited by
surveyors demonstrated improvement by implementing one or more of the
recommendations given during the COW survey process.
Ms. Hassan shared some of the positive feedback CMS has received regarding the
survey process and summarized CMS recommendations regarding the COW project.
A member requested information on the clarified definition of IJ provided to
surveyors. Ms. Perfetto responded that
the clarification dealt with the issue of testing beyond the scope of the CLIA
certificate. Another member expressed
that testing beyond the scope of the certificate does not correspond with the
definition of IJ the Committee received at the February 2004 meeting, which was
"imminent and serious risk to human health."
Ms. Perfetto reiterated that the problem was with some of the surveyors
interpreting "testing beyond the scope of the certificate" as not having
appropriate quality assurance systems or personnel qualifications in place for
the level of testing (moderate or high complexity), which could present a risk. Some of the surveyors had been interpreting these as IJ situations
without obtaining CMS confirmation. During
validation of the data, these erroneous entries were identified and corrected.
Another member suggested CMS consider forming a category other than IJ for deficiencies
involving COW laboratories performing non-waived tests.
CLIAC members noted that the February 2004 CLIAC Summary Report and addendum did not
accurately reflect the corresponding presentation and discussion regarding IJ
data (the preliminary data presented to CLIAC showed 2% of surveyed COW
laboratories operated under IJ conditions, whereas the February 2004 CLIAC
Summary Report and addendum reported the verified and revised data showing 2
cases of IJ). Some members mentioned they
presented the preliminary data at subsequent organizational and professional
meetings and stated they should have been notified at the time of data
correction. Dr. Sundwall agreed and
apologized for the oversight. He
explained that some Committee members were informed, but this information
should have been shared with the entire Committee.
He also commented that the current (September 2004) CLIAC Summary Report should
acknowledge the discrepancy between what was actually presented at the February
2004 meeting and what was posted in the meeting's CLIAC Summary Report on CDC's
website. Ms. Whalen explained the
Committee's discussions prompted by the high number of IJ cases in the
preliminary data were not reported in detail in the February 2004 CLIAC Summary
Report since those discussions were based on data subsequently determined to be
incorrect. She further explained that the
IJ data listed in the addendum of the February 2004 CLIAC Summary Report were
corrected before release with an accompanying note that the data were
A member stated the IJ data presented by Ms. Hassan seemed to be in conflict with
the revised data from the February 2004 CLIAC meeting; e.g., CMS is currently
stating one case of IJ and the revised data mentions two cases of IJ.
Ms. Hassan explained there was one case of IJ associated with the CMS
COW survey visits, while the second case was reported from a nursing home
investigation. CMS included the
information regarding the second case in the revised data to illustrate
proactive steps were taken toward preventing similar incidents in nursing
A member inquired whether the CMS data could be extrapolated beyond the inspected
laboratories. Ms. Hassan responded the
sample size was small, representing only 2% of COW laboratories, and the sample
selection was not completely random. She
noted, however, the data are consistent from year to year and correlate well
with similar studies of waived testing practices.
Centers for Disease Control and Prevention (CDC) Update
Dr. Devery Howerton updated the Committee on plans to publish CMS COW data in conjunction with other
waived testing data collected by CDC in the Morbidity
and Mortality Weekly Report (MMWR), as discussed at the February 2004
CLIAC meeting. She noted, since corrected
data from the COW surveys did not indicate a significant number of IJ cases, a
more appropriate route would be to publish a comprehensive report incorporating
CMS survey data, CDC's Laboratory Medicine Sentinel Monitoring Network data,
and a "good laboratory practices" guideline for waived testing in MMWR's Recommendations and Reports.
Dr. Howerton then gave an overview of waived testing statistics, outlined a
proposal to create a workgroup to develop the guideline, and provided a
proposed timeline to develop and publish the MMWR Recommendations and Reports article.
A member noted the Joint Commission on Accreditation of Healthcare Organization's
2004 Laboratory Accreditation Standards includes a section on waived testing
and suggested there may be other organizations with material that could be used
as a framework for developing a good laboratory practices guideline for waived
Dr. Sundwall requested and received volunteers from the CLIAC to participate in the
Good Laboratory Practices for Waived Testing Workgroup. The Committee also supported CDC's proposal to include additional
individuals on the workgroup who are stakeholders with regard to waived
testing, e.g., clinicians, nurses, and manufacturers.
Dr. Sundwall suggested a letter be sent to CMS emphasizing the importance of
continued funding for the CMS COW surveys and monitoring of waived testing
facilities. Members agreed and Dr.
Sundwall and Dr. Martin agreed to formulate the letter.
Shortly after the September 2004 Meeting, Ms. Yost notified Dr. Sundwall that
CMS had received funding to continue the COW surveys in 2005 and a letter from
CLIAC to CMS was not needed. Ms. Yost
thanked CLIAC for its continued support of CMS's waived laboratory
Genetic Testing Update
Dr. Joe Boone, Associate Director for Science, DLS, PHPPO, CDC, presented an overview of CDC's
efforts to establish a sustainable process to make quality control (QC)
materials available to the genetic testing community in order to promote and
facilitate QC, test validation, proficiency testing/external quality assessment
(PT/EQA), and the development of new genetic tests.
He summarized projects related to these efforts from 1998 to the present and
reviewed three QC Materials for Genetic Testing Conferences, organized by CDC
in collaboration with the National Institutes of Health (NIH), and the National
Institute of Standards and Technology (NIST) in 2003-2004.
Participants of the conferences, including experts in genetic and
genomic testing from professional organizations, government agencies, industry,
laboratories, and academic institutions, developed recommendations for
assessing areas needing improvement, prioritizing, and sustaining the process
to collect, store, validate, and distribute QC materials at a reasonable cost.
In addition, Dr. Boone reported on the activities and outcomes from the May 2004 Rare Disease Testing
Conference, a collaborative effort of CDC, NIH, the Health Resources and
Services Administration, the American Society of Human Genetics, the
of Medical Genetics, the Genetic Alliance, and
He provided the CLIAC members two articles from the Journal of Molecular
Diagnostics referencing quality assurance issues in molecular genetic testing.(Addenda
A member asked for an estimate of the top five genetic tests currently performed.
Committee members with genetics expertise responded that only the test
for cystic fibrosis carrier status is considered a standard of care, but other
frequently performed tests include fragile X, factor V Leiden, factor II
(prothrombin) mutation, and HFE-related hereditary hemochromatosis.
Another member asked if these efforts were in collaboration with those doing newborn
screening using tandem mass spectrometry.
Dr. Boone replied some of the participants who attended the Rare Disease
Testing Conference are involved with newborn screening.
He discussed the issue of nonuniformity of newborn screening test menus
among states and past debates regarding whether these tests are actually
genetic tests. Currently, he said, the
consensus is they are genetic tests.
One member commented on the use of controls by making a comparison between
hemoglobinopathy testing, where a laboratory does not include a positive
control for every possible variant found with isoelectric focusing; and
multiplex cystic fibrosis testing, where a laboratory may be expected to have a
positive control for every mutation to be detected.
The commenter speculated the difference in control requirements might be due to
variation among professional group recommendations.
The commenter further expressed an expectation of guidance from CLIA, since
genetic testing regulations are being formulated for publication as a proposed
rule. Dr. Sundwall asked Dr. Boone and
Ms. Whalen if the unpublished CLIA proposed rule for genetics testing would
address proficiency testing, QC, or personnel-related requirements.
Ms. Whalen responded that the current CLIA regulations contain general
quality control requirements that are applicable to genetic testing as well as
specific requirements for cytogenetics. The
genetic testing regulation under development would include proposed
requirements for personnel and quality control procedures specific to genetic
Dr. Boone raised the issue of "genetic exceptionalism" confronting the entire
advisory community, including CLIAC. He
noted there is no clear decision whether genetic testing should be treated
differently than other laboratory testing.
Cytology Proficiency Testing
Ms. Rhonda Whalen updated the Committee on CDC's progress in developing its computer-based
alternative (Cytoview™ II) to glass slide-based proficiency testing (PT) for
cytology. She reported the findings of a
recent CDC study, undertaken with the Maryland Department of Health and Mental
Hygiene, to compare gynecologic cytology PT performance using glass slides and
virtual slides. This study demonstrated
that, with field validation of virtual slide test challenges by both
pathologists and cytotechnologists, computer-based PT can be effectively
equivalent to glass slide-based PT. Ms.
Whalen noted the journal Acta Cytologica
has approved for publication an article detailing the study.
A Committee member raised the question of possible selection bias, asking what
fraction of Maryland cytologists the study volunteers represented.
Ms. Whalen said there were originally 122 volunteers out of about 600 Maryland
examinees, but participants were limited to in-state volunteers to achieve more
control for biases resulting from excess time between testing events and from
the order of testing events. The same
member requested a numerical breakdown of test volunteer age/experience levels,
as they might relate to variable experience with and acceptance of computer
formats. Ms. Whalen responded a post-test
interview queried examinees about their comfort level with the virtual format.The data indicated those less comfortable with virtual format and those
taking longer to complete the test achieved lower scores on the virtual test.
Dr. Martin acknowledged Dr. Suzanne Smith, Acting Director, Public Health Practice Program Office
(PHPPO), CDC, for her contributions to CLIAC.
Dr. Sundwall also complimented her for her enthusiasm and advocacy for the
field of laboratory medicine. Dr. Smith
thanked CLIAC and DLS for the recognition, noting that in presenting this
update on CDC's Futures Initiative, it would be the last time she would address
CLIAC from her role as PHPPO Acting Director, as she would be moving to a
position in CDC's Office of the Director.
Referring to CDC's new organizational chart (Addendum
M), she stated most
CDC Centers, Institutes, and Offices would remain the same.
She summarized the process for change, saying there was much discussion
following an outside-in approach to an agency evaluation initiated by CDC
Director, Dr. Julie Gerberding.
This approach was designed to inform CDC leadership of necessary organizational
changes to increase CDC's effectiveness. From
a variety of proposals, CDC leadership chose a blended model that would
maintain the strengths of several important units, yet accomplish necessary
changes to CDC's organizational structure.
Although many organizational units will remain unchanged, PHPPO and the
Epidemiology Program Office will not remain as separate entities.
Dr. Smith described the transition as an opportunity for PHPPO and DLS
to grow their missions, ideas, and talents to further benefit CDC.
Most of DLS will be part of the
for Health Information and Service (CoCHIS).
Centers within this unit will interact directly with consumers and other
important sectors external to CDC. Dr. Smith
commended DLS's strength in establishing and maintaining external partnerships,
citing examples of its work with the Institute for Quality in Laboratory
Medicine (IQLM) and long-term relations with CMS and FDA.
She stated the Futures Initiative provides an opportunity for the
laboratory sector to lead the way toward CDC's new iteration.
NON-REGULATORY APPROACHES TO LABORATORY IMPROVEMENT
Dr. Robert Martin introduced the meeting's main topic: Non-Regulatory Approaches to Laboratory
Improvement. He discussed the
responsibility of government to assure protection of the public's health and
the challenge this represents in an era of rapidly emerging and evolving
laboratory testing technologies. He
suggested more timely and responsive alternatives to regulatory processes are
needed to keep pace with scientific discoveries and new technologies while
assuring quality care. Dr. Martin noted
the healthcare industry has lagged behind other industries in the trend towards
non-regulatory approaches to quality issues.
However, the healthcare industry is striving to improve.
In conclusion, Dr. Martin said the meeting's presentations on
non-regulatory approaches to laboratory improvement would provide a foundation
for discussing possible alternatives to regulation as a means to assure
International Perspective: Non-Regulatory Quality Measures for Medical Laboratories
Dr. Michael Noble, Department of Pathology and Laboratory Medicine, University of
British Columbia, director of an ISO-certified (International Organization for
Standardization) microbiology PT program for Canadian clinical and water
laboratories, provided an overview of the global approach to laboratory
standards. He began by stating the move
towards uniform laboratory standards worldwide is seen in two different lights.
One group views it as global harmonization and a means to improve trade
and healthcare and another group views it as international globalization
leading to a loss of jobs. He detailed
the evolution of quality management relative to ISO standards, describing it as
a 45-year linear progression from quality management in general (ISO
9000-continuous improvement and client satisfaction) to quality management for
laboratories (ISO 17025-technical competence) to quality management for medical
laboratories (ISO 15189-laboratory cycle and principles of clinical
management). He also discussed the
benefits derived from the ISO standards documents, noting that each builds upon
the other while retaining their unique strengths.
Dr. Noble stated together, the three documents provide a solid basis for
management to self-direct toward improving the quality of medical laboratory
performance, with ISO 15189 rapidly becoming an international standard.
The mutual recognition arrangement (MRA), detailed in ISO 17025,
provides laboratory accreditation reciprocity between nations.
Dr. Noble discussed challenges faced when forming consensus documents.
He suggested these relate mostly to difficulties inherent in the
consensus process wherein numerous organizations want to ensure the final
documents are useful in their individual settings.
Additionally, there is a linguistic challenge (e.g., accreditation versus
certification versus registration) with different groups assigning different
meanings to each of these terms. Dr.
Noble concluded by reiterating ISO 15189 is becoming the standard for quality
systems in medical laboratories worldwide.
The addendum was revised from material provided in the Committee's notebooks to
reflect last minute updates by the presenter.
A Committee member asked if the ISO organization began in the
United States. Dr. Noble replied Bell
Laboratories developed a quality process that evolved into a military standard,
then a NATO standard, then a British Standards Institute standard.
ISO evolved at each step until it became what it is today, a 72-country
organization of equal voices to create voluntary consensus documents.
The first ISO conference was held in
Geneva, Switzerland in 1974.
Another member inquired where the ISO is headquartered, who staffs it, and how it is
funded. Dr. Noble replied that the
Secretariat is located in Geneva
and member dues and the sale of standards fund ISO activities.
member inquired about the ISO certification process.
Dr. Noble explained ISO certification is a voluntary process.
An organization seeking certification must be approved by an association
recognized by ISO to perform certifications and must undergo annual
inspections. Certification fees are
dependent on the organization's size and complexity.
members requested clarification about the ISO standards development process.
described five voting steps: working document, committee draft, international
draft, final international draft, and standard.
If there are not enough consensus votes to proceed during one of these steps,
the committee has the option of placing the idea/recommendation as a technical
report/guidance document, which does not carry as much weight as a standard.
Dr. Noble emphasized ISO standards are reviewed every five years and
either re-adopted or revised.
Dr. Sundwall asked if NCCLS and ISO standards are competitive or complementary.
Dr. Hearn replied NCCLS considers ISO standards complementary to NCCLS
Quest Diagnostics' Experience: Non-regulatory Quality Standards
Mr. George Pounds, Manager, Clinical Immunology at Nichols Institute, Quest Diagnostics, began his
presentation with an explanation of the reasons why Quest sought ISO
certification and adopted the Six Sigma methodology.
He suggested thinking of ISO as a systems or infrastructure approach and Six
Sigma as a more focused method for effecting process improvements.
Quest's business goals - increase the quality of laboratory service,
increase productivity and efficiency, and attract and retain the most qualified
employees - were not met by compliance with regulatory standards alone.
Mr. Pounds described the stepwise approach to ISO and Six Sigma
implementation throughout Quest and detailed the lessons learned and benefits
derived from these undertakings.
In terms of cost savings, Mr. Pounds provided examples illustrating Quest's perspective that quality
will always be the lowest cost option to the overall system.
He explained costs may increase in a given area or step in a process,
but in terms of the overall system, the best quality system will also be the
lowest cost system. Mr. Pounds detailed
the evolution of quality in manufacturing from the 1920s to the present, and in
the clinical laboratory industry from the 1950s to the present, noting clinical
laboratories have only recently begun to employ the highly evolved system of
strategic quality management. He provided
an illustration of the stages of quality defined in NCCLS GP26 and the extent
to which they are addressed by the some of the various regulatory and
non-regulatory programs (CLIA, CAP, ISO 15189, and ISO 9001), as well as Six
Sigma. Mr. Pounds concluded his
presentation with a discussion of the 2000 revision of ISO 9001.
Dr. Sundwall inquired whether the cost savings demonstrated by Quest are replicable
to other laboratories that have attained ISO certification.
Mr. Pounds explained Quest's cost savings resulted from the combination
of ISO certification and Six Sigma. He is
aware of two other ISO-certified facilities that have also realized dollar
A Committee member stressed one of the critical components of both ISO and Six
Sigma is the total commitment of the senior executive team over the long term.
The member further noted the average tenure of a CEO today in a major
healthcare system is less than three years, creating a major healthcare crisis
resulting in not having the management and decision-making environment needed
for these quality programs.
In response to a query on the role of strategic planning, Mr. Pounds explained the
Quest CEO leadership team distributes a strategic plan "roadmap" annually to
all business units addressing quality and financial information and employee
satisfaction issues. The business units
design their individual strategic plans to align with this high-level plan.
A member inquired about the use of information technology (IT) in this project.
Mr. Pounds replied IT was critical in the first 1-2 years of
implementation, which were spent creating a system of reliable measures to
A member observed that laboratories successful at implementing high-level quality
programs tend to be reference laboratories with strong, creative IT support and
a more predictable work pace, neither of which is typically found in hospital
laboratories. Mr. Pounds commented
Quest's success with the IT aspect relied on pairing a laboratorian with an IT
Another member reported chronic staff shortages prevent dedicating personnel for work
on ISO implementation, stating data supported this situation as similar
elsewhere. Mr. Pounds acknowledged that
in a hospital environment, administration support and funding is vital, whether
provided through internal staffing or obtaining outside consultation.
Members asked whether Quest relied on the expertise of its own employees to address
quality issues or employed consultants and whether employee involvement
resulted in improved organizational buy-in.
Mr. Pounds replied Quest relied on employee expertise to address quality, as
they are most familiar with the business.
Results of Quest's employee satisfaction surveys affirm that involving
employees creates a team atmosphere.
Overview of National Voluntary Standards for Laboratory Improvement
Dr. Thomas Hearn, Deputy Director, DLS,
PHPPO, CDC, and President of NCCLS, introduced the topic of voluntary standards
and summarized how they differ from regulations in their purpose, process,
impact, and oversight. He noted
regulations serve a useful function, providing a safety net for patient care,
but represent the low bar for quality. In
contrast, voluntary standards often represent higher standards of quality and
address additional aspects such as technical dimensions, management direction,
and basic customer service elements. Dr.
Hearn stated the presenters represent organizations known for their voluntary
standards development and they will share their experiences in setting
voluntary standards and the impact of those standards.
He then provided a framework to guide Committee discussion following the presentations.
NCCLS: Global Consensus Standardization for Health Technology
Dr. Robert Habig, President Elect, NCCLS, and Vice President, Regulatory
Affairs and Compliance, Abbott Laboratories, defined NCCLS as a
consensus standards organization accredited by American
National Standards Institute (ANSI) and a volunteer, not-for-profit, global,
and educational organization with multi-constituency.
Dr. Habig reviewed NCCLS's principles, responsibilities, and activities
and explained its project selection, document development, and evaluation
processes. He pointed out that NCCLS
standards, guidelines, and documents are distributed and used worldwide,
recognized by FDA, used in professional practice guidelines, and referenced in
government regulations and international standards.
He discussed new technical and process developments for the organization and
noted an upcoming Equivalent Quality Control Workshop sponsored collaboratively
by the American Association for Clinical Chemistry (AACC), the American Society
for Clinical Laboratory Science (ASCLS), AdvaMed, CDC, CMS, FDA, and NCCLS on
March 18, 2005, in Baltimore, Maryland.
Dr. Habig announced NCCLS's name will change, effective
January 1, 2005,
to the Clinical and Laboratory Standards Institute (CLSI).
CDC: Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus (HCV)
Dr. Frederick Nolte, Professor of Pathology and Laboratory Medicine, Emory University School of Medicine, and
Director, Clinical Microbiology and Molecular Diagnostic Sections, Emory
Medical Laboratories, shared his experience participating in a CDC workgroup to
develop guidelines for hepatitis C virus (HCV) antibody testing, confirmation,
and result reporting. He acknowledged
there was a lack of established guidelines for this testing before this
workgroup was formed and there is still a lack of understanding by healthcare
professionals regarding screening and confirmatory test performance
characteristics and interpretation of test results.
The workgroup consisted of representatives from FDA, the public health
community, hospital and independent laboratory sectors, and medical laboratory
professional organizations such as the American Society for Clinical Pathology
(ASCP), the College of American Pathologists (CAP), and AACC.
The workgroup developed testing guidelines and an algorithm for
confirmatory testing, which were published
February 7, 2003, in CDC's MMWR.
In discussing the impact of the guidelines, Dr. Nolte noted that adoption of the guidelines' algorithm saved his
institution $31,000 annually but acknowledged it may result in added costs to
facilities that have not routinely confirmed positive screening test results.
He identified other positive impacts of following the guidelines as
improvement in the accuracy of test results, better utilization of medical
resources, and better public health surveillance.
The addendum was revised from material provided in the Committee's notebooks to
reflect last minute updates by the presenter.
One member asked Dr. Nolte who bears the extra cost for the recommended reflexive
confirmatory testing. He responded the
costs are passed along to the patient.
Another member asked Dr. Nolte whether the signal to cutoff ratios are reported to
physicians, and if so, whether physicians know how to interpret them.
He replied the signal to cutoff ratio values are not reported; these
values are for the laboratory's use.
A positive screening test result is reported as a low positive or a high
positive result and the test report informs the physician of the reflexive
confirmatory testing to follow.Laboratories
that do not routinely perform reflexive testing should advise physicians when
additional testing is recommended.
When asked how to garner physician acceptance of recommended reflexive testing, Dr.
Nolte responded his organization has a committee of physicians that annually
reviews all reflex testing protocols in the laboratory.
The committee consists of "opinion leaders" that convey the need for
reflexive testing to the medical staff.
A member inquired whether different hepatitis C strains exhibit different
antibody responses using the antibody screening tests.
Dr. Nolte responded there were some concerns with earlier generations of
screening and nucleic acid tests, but the problems have largely been eliminated
in subsequent test generations.
Dr. Nolte was asked whether recombinant immunoblot assay (RIBA) is the gold
standard for HCV testing and for recommendations regarding indeterminate RIBA
results. He responded that RIBA is the
gold standard for antibody testing and when RIBA results are indeterminate, the
options are to retest the patient after a
waiting period or to proceed to nucleic acid testing.
Ms Louann Ochs informed the Committee the reimbursement rate ($27) quoted in the
presentation for HCV nucleic acid testing has been challenged by industry.
She stated CMS has agreed this rate is too low and needs to be raised;
however, the change has not yet been implemented.
The American Society for Microbiology (ASM) Practice Guidelines: Development and Publication
Dr. Alice Weissfeld, President and CEO of Microbiology Specialists Incorporated, and former CLIAC member,
presented ASM's process for writing its practice guidelines,
Cumulative Techniques and Procedures in Clinical Microbiology, better
known as the Cumitech series. She
explained ASM's collaborative approach in identifying topics and writing
guidelines. Dr. Weissfeld also reviewed
the purpose of the Cumitech series and gave examples of current Cumitechs and
those under development. She explained
ASM's "fast-track approach" to write and post urgent guidelines on ASM's
website, with a turnaround time of six to eight months, and provided some
examples, such as the Clinical Laboratory Bioterrorism Readiness Plan Template
and guidelines specific to bioterrorism agents.
One member commented Cumitechs are excellent guidelines and pointed out the importance of circulating
the information, particularly in the infectious disease community.
College of American Pathology (CAP): Non-Regulatory Approaches to Laboratory Improvement
Dr. Richard Friedberg, Chairman, Department of Pathology, Medical Director, Baystate Reference
Laboratories, and active on numerous CAP committees, presented an overview of
CAP's non-regulatory approaches to improvement in clinical and anatomic
pathology laboratory medicine. CAP's
Quality Improvement Programs focus on developing and implementing quality
improvement activities, establishing realistic benchmarks, accreditation,
research, and professional education. Dr.
Friedberg described these programs, which include Q-PROBES, Q‑TRACKS,
Surveys Interlaboratory Comparison Programs, EXCEL, scientific literature and
consensus statements, and continuing education programs.
He discussed some of the quality issues studied by Q-PROBES and Q-TRACKS
and gave examples of interventions and positive outcomes resulting from a
Q-TRACKS study of wristband errors.He
identified the new 2005 Q‑PROBES and Q-TRACK offerings and
acknowledged the challenges laboratories face in providing outcomes data.
Dr. Friedberg announced CAP was recently awarded a CDC cooperative
agreement, "Assessment of Quality Assurance Best Practices Using Clinical
Outcomes Evidence," which should yield needed real-time data.
A member inquired whether the EXCEL PT Program would be burdensome for waived
laboratories and if the EXCEL program has data showing participation by COW
laboratories that were also inspected by CMS.
Ms. Whalen responded CMS has a database to track laboratory participation in PT
programs and it may be possible to link this database with CMS data of
laboratories inspected through the COW project.
Discussion among members followed regarding CMS data showing approximately 7%
of COW laboratories participate in PT programs.
Several members commented that economics is a barrier to getting PT programs
into waived testing facilities. One
member suggested lawyers and risk managers may be more likely to offer support
for funding PT programs as a mechanism for quality improvement because they see
it as a way to decrease liability. Hospital
and finance administrators are less likely to subscribe to anything other than
what is required, unless there is a financial incentive to do so.
A member pointed out the need for communication and increased sharing of data
among organizations, e.g., JCAHO and CAP, so hospital administrators and CEOs
nationwide would be aware of current quality issues in laboratory medicine.
Examples were shared among members of instances where issues addressed
by CAP's Q-PROBES were adopted by another organization and resulted in the
development of a standard.
COLA: Voluntary Standards and Non-Regulatory Approaches to Laboratory Improvement
Mr. Max Williams, Director, Policy and External Affairs, COLA, described COLA as a physician-directed
organization of 6,700 laboratories, originally founded for physician office
laboratories, with deemed authority from CMS as a CLIA-approved accrediting
organization. Mr. Williams explained
COLA's guiding principles for standard development, the use of its constituency
expertise in developing standards, and its evaluation/benchmarking processes.
He announced COLA is currently adding the specialties of cytology and
histopathology to its program. Mr.
Williams concluded his presentation by describing COLA's current and future
considerations for performance improvement, e.g., quality management systems,
ISO 15189, on-line education, risk mitigation, improving waived test
performance, and drivers for performance improvement.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO): Raising the Bar for Patient Safety
Ms. Joanne Born, Executive Director, Laboratory Accreditation Program, JCAHO, described
JCAHO as a non-profit healthcare accrediting body for hospitals,
laboratories, ambulatory and long-term care facilities, and home health
agencies. The organization sets standards
and develops National Patient Safety Goals (NPSGs) to improve healthcare
quality. Ms. Born explained JCAHO's
Sentinel Event Advisory Group develops NPSGs to address gaps identified in
healthcare quality and she detailed the NPSG development process.
To evaluate an organization's compliance with standards and NPSGs, JCAHO
uses "tracer methodology," in which surveyors select a patient, resident, or
client and use that individual's record as a roadmap to move through the
organization's systems of providing care and services.
Ms. Borne concluded by discussing JCAHO's 2005 National Patient Safety
Goals for laboratories - improve accuracy of patient identification, improve
effectiveness of communication among caregivers, and reduce the risk of
Implementation of NCCLS Antimicrobial Susceptibility Testing Standards
Dr. Fred Tenover, Associate Director for Laboratory Science, Division of Healthcare Quality
Promotion, National Center for Infectious Diseases, CDC, detailed the role and
implementation of NCCLS Antimicrobial Susceptibility Testing (AST) standards in
clinical microbiology (specifically, bacteriology).
He began by stressing the importance of AST data collected by clinical
microbiology laboratories throughout the country and their usefulness
individually and aggregately. These data
are used to manage therapy for infections in individual patients, guide empiric
therapy, and serve as the basis for infection control activities.
He noted the data have considerable value for use in local, regional,
and national databases for evaluating trends in emerging resistance.
Dr. Tenover explained that in developing AST standards and guidelines, NCCLS considers data from the
pharmaceutical industry, government and public health agencies, academia, and
individual microbiologists. The current
NCCLS AST standards for bacteriology are addressed in six documents and provide
methods for antimicrobial susceptibility testing, quality control and
assessment, interpretive criteria, and recommendations for reporting results.
Dr. Tenover added that a future document will address AST for "orphan"
organisms and guide laboratories in testing and reporting organisms when no
interpretive criteria are available. NCCLS
responds to customers by annually distributing updated M100 Supplements, which
provide new and revised breakpoints, new screening tests, and clarifications of
testing methods.The supplements also
address major changes in standards, answer questions raised by users regarding
test methods or breakpoints, and encourage continuous feedback to NCCLS
Dr. Tenover described the methods for establishing sensitive, resistant, and intermediate breakpoints
for organisms using either disk diffusion or MIC methods and noted there are
some problems related to AST methods, breakpoints, and QC testing.
In response to some of these problems, NCCLS plans to publish
updated breakpoints for Enterococcus faecium and daptomycin, a new table devoted to Neisseria
meningitidis, and a new document addressing testing of fastidious and
infrequently isolated organisms. Dr.
Tenover emphasized the goal of the AST standards is to generate accurate and
*Note: The addendum was revised from material provided in the Committee's notebooks to
reflect last minute updates by the presenter.
One Committee member inquired whether cautionary instructions for working safely
with Neiserria meningitidis would be
included in the new M100 table. Dr. Tenover affirmed that the new document has safety warnings
for these organisms. In addition, there
is now a table on safely testing organisms used as agents of bioterrorism.
Another member asked about the cost effectiveness of the new vancomycin screening
guideline. Dr. Tenover responded the new
guideline is viewed as interim until automated susceptibility systems are
capable of detecting vancomycin-resistant Staphylococcus
Institute for Quality in Laboratory Medicine (IQLM)
Dr. Toby Merlin, Associate Director for Laboratory Medicine, DLS, PHPPO, CDC, updated the Committee
on activities related to IQLM. He stated
there are opportunities for improvements in quality and safety in
U.S. healthcare and cited reasons why the laboratory is a focal point for
improvement. Noting attention should be paid to quality in all phases of
laboratory testing, he said the IQLM seeks to address these issues by promoting
improvements in laboratory testing and services to benefit public health.
Dr. Merlin reviewed the nine-part IQLM agenda and projects underway:
creation of an awards and grants program, development of laboratory and partner
networks, development of indicators and progress monitors, and creation of a
national report to identify issues and best practices.
He pointed out that the IQLM is designed to accomplish these goals
through the cooperation of laboratory professionals, clinicians, accrediting
organizations, consumers, administrators, policy makers, the diagnostics
industry, and payers. After listing
IQLM's partner organizations and a brief review of the Awards, Indicators, and
Networks Workgroups and their leaders, Dr. Merlin concluded with a schedule of
upcoming IQLM events: the October 2004 Partners and Workgroups Meetings and the
April 2005 IQLM Conference.
*Note: The addendum was revised from
material provided in the Committee's notebooks to reflect last minute updates
by the presenter.
A Committee member suggested the IQLM is the best forum for bringing groups
together to inspire greater participation in voluntary activities to improve
quality. Another member expressed
appreciation for the IQLM's initiatives and stressed laboratorians must be
proactive in raising hospital administrators' awareness of the laboratory's
impact on patient outcomes.
One member proposed the IQLM should concentrate on identifying incentives to change
behavior that will result in improved quality, outcomes, and healthcare.
Some insurers are considering setting reimbursement levels contingent on
various quality measures. The member
further commented some laboratories are willing to participate in the voluntary
efforts of organizations such as CAP and COLA.
Members agreed financial incentives trigger actions and emphasized performance
measures should be tied to the reimbursement process.
A member asked whether any risk management organization was involved in the IQLM.
Dr. Merlin responded that the Association of Risk Managers is a partner
Another member suggested IQLM focus on obtaining better data and commented that data
demonstrating impact on patients, determining outcomes, and illustrating the
inverse relationship between quality improvement and cost would gain the
attention of administrators. Dr. Sundwall
responded that the Laboratory Health Care Coalition has funded a study
conducted by economist Dr. Frank Lichtenberg of
Columbia University, to quantify the economic benefit of clinical laboratory testing.
Ms. Luann Ochs stated the importance of using marketing strategies to
publicize laboratory success stories. She
commented that emphasizing the financial impact of quality and efficiency and
stressing small investments would provide great returns.
Dr. Merlin responded that the April 2005 IQLM Conference will focus on
the business case for quality. Additionally,
bestowing the first IQLM awards will enhance efforts to draw public attention
to accomplishments in laboratory medicine.
A member observed the extensive coverage given to health information and
standards in the popular media and suggested the need for a media award
specifically for reporting the importance of laboratory quality as it relates
to care for a given disease.
Other comments made by Committee members include the following:
There is a need to communicate to the public and to payers the importance of
demonstrating in measurable ways that quality is important.
To effect quality improvement, the laboratory should communicate
directly with both physician and patient clients, helping them to use the
information generated by the laboratory so the client perception of the
laboratory is as a source of high-quality information that will improve
A shift in public policy toward the pay-for-performance approach currently under
consideration by CMS and other insurers could result in the untoward
consequence of a two- or three-tiered healthcare system.
In order to inform the policy-making process, congressional delegate members or
their legislative aides on health issues should be invited to the laboratory to
observe the quality processes in place and to witness first-hand the
laboratory's critical role in patient care.
As hospitals bring new information systems online, a laboratory interface with the
IT committee to build algorithms into the system to enforce practice guidelines
will encourage best practices.
Quality improvement pilot programs in underserved hospitals that may be more open to
making policy and procedural changes known to result in cost savings could
perhaps be conducted under the auspices of CDC.
Computer-Based Proficiency Testing for Cytology
Dr. George Birdsong, American Society of Cytopathology submitted a written comment
Dr. Sundwall acknowledged the Committee's concerns as to the extent non-regulatory
approaches can result in quality improvement due to the limited resources
available to adopt and participate in these voluntary programs.
He concluded the meeting with a review of the following action items:
Good Laboratory Practices for Waived Testing Workgroup, chaired by Dr. Jared
Schwartz and Dr. Kathy Foucar, will meet and report its findings to CLIAC in
The Chair will write a letter to CMS on behalf of the Committee, supporting
continuing the CMS COW surveys beyond 2004.
(NOTE: Shortly after the September 2004 Meeting, Ms. Yost notified Dr. Sundwall
that CMS had received funding to continue the COW surveys in 2005 and a letter
from CLIAC to CMS was not needed.)
Dr. Sundwall announced the 2005 CLIAC meetings are scheduled for February 16-17, and September 7-8,
and adjourned the CLIAC meeting.
I certify this summary report of the
September 22-23, 2004
meeting of the Clinical Laboratory Improvement Advisory Committee is an
accurate and correct representation of the meeting.
David Sundwall, M.D., CLIAC Chair
This page last reviewed: 3/30/2005