[Congressional Record Volume 151, Number 13 (Wednesday, February 9, 2005)]
[House]
[Page H495]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CLINICAL LABORATORY COMPLIANCE IMPROVEMENT ACT OF 2005
The SPEAKER pro tempore. Under a previous order of the House, the
gentleman from Maryland (Mr. Cummings) is recognized for 5 minutes.
Mr. CUMMINGS. Mr. Speaker, today I am introducing the Clinical
Laboratory Compliance Improvement Act of 2005, legislation to improve
accuracy and reliability in medical testing and provide protection for
employees who report laboratory problems to their superiors or
regulatory entities.
Medical laboratory testing is a fundamental pillar of our Nation's
health care system. Virtually every American undergoes testing in the
course of receiving medical care and relies on the accuracy of
laboratory tests to receive appropriate medical care and treatment.
Incorrect test results in the worst case can contribute to a
misdiagnosis that leads to inappropriate care and possible adverse
health consequences for the patient. In the best case, incorrect or
invalid results can lead to undue stress and inconvenience.
Inaccurate testing for communicable diseases can pose a serious
threat to the public health. In May and July of 2004, the House
Subcommittee on Criminal Justice, Drug Policy and Human Resources of
the Committee on Government Reform held hearings to investigate lab
deficiencies that led to the release of hundreds of invalid test
results by the Maryland General Hospital located in my district in
Baltimore City. I requested the hearings as the subcommittee's ranking
minority member, and with the cooperation and support of the
distinguished chairman, the gentleman from Indiana (Mr. Souder), the
subcommittee conducted the hearings on a strictly bipartisan basis.
During the hearings, the subcommittee received testimony from Teresa
Williams and Kristin Turner, two former laboratory employees who
complained to superiors and State health officials about serious, long-
standing deficiencies in the lab, including failure to implement
quality controls on a diagnostic device used to read tests for HIV and
hepatitis.
Officials from the Food and Drug Administration and the Centers for
Medicare and Medicaid Services, responsible for implementing Federal
regulations governing medical diagnostic devices and laboratory
operations, respectively; the former chief executive of Adaltis US,
Inc., manufacturer of the device used to run the invalid test; the
College of American Pathologists, a private accrediting organization
responsible for certifying the laboratory's compliance with Federal and
State regulations on behalf of CMS and the State; and the Maryland
Department of Health and Mental Hygiene all testified.
It was Ms. Turner's complaint in December 2003 that triggered
investigations by the State CMS, the Joint Commissioner on
Accreditation of Healthcare, JCAHO, and CAP, between January and March.
The investigations confirmed Ms. Turner's allegation that during a 14-
month period between June 2002 and August 2003, Maryland General
Hospital issued more than 450 questionable HIV and hepatitis test
results to hospital patients.
During this time period, the hospital laboratory was inspected and
accredited for 2 years by CAP, receiving CAP's Accredited With
Distinction Certificate. Despite an earlier anonymous complaint by Ms.
Williams and several colleagues, the State also was unable to identify
the problems, and serious deficiencies in two key departments of the
lab went undetected by CAP and the State until January of 2004.
In Spring of 2004, inspectors from the States' EMS and JCAHO
concluded that the laboratory staff had falsified federally required
instrument quality control results and reported patient results even
though quality control checks had failed. Learning of the problems by
way of news reports, CAP conducted a complaint inspection in April,
found similar deficiencies, and suspended accreditation of the lab's
chemistry and point-of-care departments for 30 days.
To its credit, Maryland General Hospital conducted its own internal
review and vigorously undertook efforts both to retest the affected
patients and to revamp the lab's leadership and operations.
Fortunately, retesting verified the accuracy of the overwhelming
majority of tests, and Maryland General has made enormous strides in
improving its lab operations so that patients receive results that are
accurate and reliable.
Nevertheless, Mr. Speaker, this is a situation that caused great
distress to the community that the Maryland General serves.
I should note that I live in that community, and I have received care
at Maryland General Hospital. This is a situation that could have put
lives in jeopardy and one that simply should never have occurred, given
the regulatory safeguards that exist to ensure quality testing.
Congress recognized the importance of ensuring that all Americans
receive accurate diagnostic test results when in enacted Federal
Standards for Medical Laboratories under the Clinical Laboratories
Improvement Amendments of 1998, now know as CLIA. Under the CLIA, the
Centers for Medicare and Medicaid Services were charged with developing
and implementing regulations to ensure that all labs conform to strict
Federal guidelines.
CMS directly inspects some labs to ensure CLIA compliance and State
health agencies are responsible for inspecting and certifying the
compliance of others. In addition, pursuant to CLIA regulations and
agreements between CMS and the States, clinical laboratories that
choose to be accredited by CAP or one of five other private accrediting
organizations, are deemed to be in compliance with State and Federal
regulatory requirements and can bill for services provided for Medicare
beneficiaries.
Mr. Speaker, there is no doubting the fact that CLIA has made medical
testing more accurate and more reliable, and surely the overwhelming
majority of labs do their best to conform to these high standards.
Unfortunately, the Maryland General case clearly demonstrates that not
all laboratories will play fair and that the current system does not
guarantee that serious instances of noncompliance will be detected or
corrected.
Testimony before the subcommittee indicated that in the Maryland
General case, laboratory supervisors failed to implement quality
control measures and deliberately masked lab deficiencies from
inspectors from CAP and the State. Employees who complained were
subject to retaliation and intimidation.
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