[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.

                          ____________________