[Congressional Record (Bound Edition), Volume 150 (2004), Part 17]
[Extensions of Remarks]
[Pages 23490-23491]
[From the U.S. Government Publishing Office, www.gpo.gov]




 INTRODUCTION OF THE CLINICAL LABORATORY COMPLIANCE IMPROVEMENT ACT OF 
                                  2004

                                 ______
                                 

                        HON. ELIJAH E. CUMMINGS

                              of maryland

                    in the house of representatives

                        Friday, October 8, 2004

  Mr. CUMMINGS. Mr. Speaker, today I rise to introduce the Clinical 
Laboratory Compliance Improvement Act of 2004, legislation to improve 
the accuracy and reliability in medical testing and to provide 
protections 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 
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 poses an especially serious threat to 
the public health.
  On March 11, 2004, the Baltimore Sun reported that Maryland General 
Hospital (MGH), located in my district had issued invalid HIV and 
hepatitis test results to hundreds of patients from June 2002 to August 
2003 when an Adaltis Labotech Immunoassay Analyzer (``Labotech'') was 
used to conduct HIV, hepatitis and other tests at the MGH lab. The 
tests results were issued despite instrument readings indicating that 
the results might be erroneous. It was also disclosed that the testing 
equipment itself might be at issue.
  In May and July of this year, the House Government Reform 
Subcommittee on Criminal Justice, Drug Policy, and Human Resources held 
hearings to investigate the lab deficiencies that led to the release of 
hundreds of invalid HIV/AIDS and Hepatitis C test results by MGH. 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, Representative Mark 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, 
longstanding 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 (CMS) responsible for 
implementing federal regulations governing medical diagnostic devices 
and for regulating laboratory operations, respectively; the former 
chief executive of Adaltis US, Inc., manufacturer of the device used to 
run the invalid tests; the College of American Pathologists, the 
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.
  In fact, it was Ms. Turner's complaint in December 2003 that 
triggered investigations by the state, CMS, the Joint Commission for 
Accreditation of Healthcare Organizations (JCAHO), and CAP, between 
January and March. The investigations confirmed Ms. Turner's 
allegations 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 two 
years by CAP, receiving CAP's Accredited with Distinction certificate 
(standard for CAP-accredited labs). 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.
  I should also point out that the ongoing faulty testing and related 
problems at the MGH lab were brought to the attention of the public 
only after former lab technician Kristin Turner filed a lawsuit.
  This spring, inspectors from the state, CMS, and JCAHO concluded that 
laboratory staff had falsified federally instrument quality control 
results and reported patient results even though quality control checks 
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 the HIV and Hepatitis C tests. In addition, Maryland 
General has made enormous strides in improving its lab operations so 
that patients receive test results that are accurate and reliable.
  Nevertheless, Mr. Speaker, this is a situation that caused great 
distress to the community that Maryland General serves, and I should 
note that I live in that community and have received care at Maryland 
General Hospital. This is a situation that could have put many lives in 
jeopardy and one that simply should never have occurred given the 
regulatory safeguards that exist to ensure quality testing.
  Mr. Speaker, Congress recognized the importance of ensuring that all 
Americans receive accurate diagnostic test results when it enacted 
federal standards for medical laboratories under the Clinical 
Laboratories Improvements Amendments Act of 1998, now known as 
``CLIA.'' Under CLIA, the Centers for Medicare and Medicaid Services 
(CMS) were charged with developing and implementing regulations to 
ensure that all labs conform to strict federal standards.
  Pursuant to CLIA regulations and agreements between CMS and the 
states, clinical laboratories that choose to be accredited by

[[Page 23491]]

CAP or one of the five other private accrediting organizations are 
``deemed'' to be in compliance with federal and state regulatory 
requirements and can bill for services provided to 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 Hospital 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; state and CAP inspection teams 
were unable to identify or verify serious ongoing deficiencies during 
accreditation and complaint surveys; and enforcement entities failed to 
share information about reports of deficiencies, investigative actions 
taken, and their investigative findings.
  Since our hearings concluded, another CAP-accredited laboratory in my 
state, Reference Pathology Services of Maryland, had its CAP 
accreditation and state license revoked because of longstanding 
deficiencies related to testing for sexually transmitted diseases and 
cervical cancer. This case and other information brought to the 
Subcommittee's attention suggest that at least some of the problems 
that occurred at Maryland General are not unique to the Maryland 
General case.
  Chairman Souder and I have asked the Government Accountability Office 
(GAO) to examine a number of issues related to the enforcement of 
federal standards for labs and I expect that investigation to tell us 
more about the prevalence of such problems.
  For now, it is unclear how many other laboratories may be 
experiencing such problems and, certainly, one would hope the number is 
few. But the record gives us little assurance that what happened at 
Maryland General could not occur elsewhere and I believe the Maryland 
General case reveals weaknesses in the current system for ensuring 
compliance with federal clinical laboratory standards.
  The bill I am introducing today aims to correct the weaknesses that 
are apparent.
  The Clinical Laboratory Compliance Improvement Act of 2004 seeks to 
improve compliance with laboratory standards by (a) facilitating the 
disclosure and detection of deficiencies by employees and (b) 
increasing cooperation and accountability among entities involved in 
the accreditation and monitoring of federally regulated medical labs.
  Specifically, the bill would amend Section 1846 of the Social 
Security statute to:
  (1) Establish whistleblower protections for employees of clinical 
laboratories and providers;
  (2) Require the Centers for Medicare and Medicaid Services, state 
health agencies, and private laboratory accrediting organizations such 
as CAP to share information about reports of deficiencies and 
investigative activity undertaken pursuant to such reports;
  (3) Require that standard accreditation surveys be conducted without 
prior notice to the provider or clinical laboratory facility to be 
surveyed; and
  (4) Require the Secretary of Health and Human Services to submit an 
annual report to Congress describing how CMS, private accrediting 
organizations, and state health agencies responded to reports of 
deficiencies during the preceding year.
  The whistleblower provisions would facilitate reporting of 
deficiencies by: Requiring that participating providers and clinical 
laboratories post a conspicuous notice advising employees how and to 
whom to report deficiencies; prohibiting retaliation by providers and 
clinical laboratories against employees who report deficiencies to CMS, 
accrediting organizations, or state health agencies; and establishing a 
federal cause of action for employees who are retaliated against for 
reporting deficiencies.
  With regard to unannounced inspections, the bill sets forth a civil 
monetary penalty of up to $2,000 for persons who provide notice to a 
lab or provider about the timing of a survey.
  Mr. Speaker, it is sad but true that we cannot afford to take it for 
granted that all laboratories will approach compliance with laboratory 
standards in a good faith manner, or even that deficiencies will be 
discovered when conscientious lab employees want to disclose them.
  The Clinical Laboratory Compliance Improvement Act of 2004 would 
reduce the likelihood that serious laboratory deficiencies will escape 
the notice of entities charged with ensuring compliance with the 
standards that we in Congress have established to ensure a high 
standard of healthcare for all Americans.
  I urge my colleagues to join me in demonstrating their support for 
strengthening our national system for ensuring accuracy and 
accountability in medical laboratory testing.
  I invite my colleagues to cosponsor this important legislation.
  Finally, I want to thank my Subcommittee counsel, Tony Haywood, as 
well as Jolanda Williams, Trudy Perkins and Kimberly Ross of my staff 
for their tireless work on this issue.

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