College of American Pathologists

CAP President Testifies Before Congress

Published on: July 7, 2004

Testimony of Mary E. Kass, MD, FCAP, before the Subcommittee on Criminal Justice, Drug Policy and Human Resources, Committee on Government Reform

Mary E. Kass, MD, FCAP

Good afternoon, Mr. Chairman, Representative Cummings and other members of the subcommittee. My name is Dr. Mary Kass, president of the College of American Pathologists.

Since the May 18 hearing, the College has conducted an unannounced inspection of the MGH laboratory as a follow-up to our April 2004 decision to suspend accreditation for two disciplines, chemistry and point-of-care testing. This inspection revealed few deficiencies and the hospital has responded to those cited. The College's Commission on Laboratory Accreditation is scheduled next week to review those responses and the status of the MGH laboratory.

As you may recall, the CAP stated in its May 18 testimony that quality control deficiencies for HIV and hepatitis C testing were not uncovered by CAP inspectors during a routine April 2003 inspection or by state inspectors in fall 2002 because quality control data in this area were found to have been edited. Specifically, Maryland state inspectors allege in their 2003 inspection report that:

  • "Review of HIV records from June 2002 through August 2003 show that approximately 10 to 15 percent of patient runs were invalid because of unacceptable values of the negative controls used to determine cutoff values."
  • On May 14, 19, 21 and 23, 2003, "instrumentation printouts showed edited control values, but there were no printouts for the plates and no other records to show repeat testing for either the control materials or the entire plate of patient specimens."
  • In a run for hepatitis C testing on July 18, 2003, "the instrumentation printout showed manually edited acceptable values for the negative control materials, but the plate printout showed unacceptable negative controls."

Based upon these findings by the state, we have concluded that neither our inspection process nor any other would have detected these problems without the benefit of the whistleblower complaint information, which ultimately led to the state's findings. I have attached a copy of the state's report for the record.

Any claim that CAP accreditation is not rigorous or objective is not supported by the facts. Mr. Chairman, I have attached to my statement the Sept. 12, 2001, Federal Register notice extending to the College deemed status under the Clinical Laboratory Improvement Amendments of 1988. A review of this document will clearly show that the CAP inspection process exceeds CLIA requirements in several areas. Moreover, our program is subject to annual CMS validation surveys conducted by state inspectors. These surveys typically are unannounced to laboratories and never announced to the College. CMS validation surveys always have shown results comparable to CAP findings and a discrepancy percentage well below the threshold that would trigger a federal review of our program. CMS, in fact, has clear authority to revoke the College's deemed status if it finds our program to be substandard. Most recently, at the May 18 hearing, CMS reaffirmed its support of CAP accreditation.

The College welcomes and has encouraged state authorities to review our program to determine whether CAP accreditation meets the requirements of their respective state laws. For example, College representatives met with Maryland Health and Mental Hygiene Secretary Nelson Sabatini on June 17 as an initial step in efforts to improve communication and formalize our relationship with the state. As a result of that meeting, we have received a letter from department director Carol Benner requesting information from the College so the state can formally evaluate the College's program for equivalence to the state program. We are encouraged by this development and look forward to continued discussions with the state.

We believe the MGH case is highly unusual and does not point to a pervasive problem in the accreditation or inspection process. But the case highlights important issues that can translate to improvements in the accreditation process.

Better Communication
The MGH case underscores the need for better communication and sharing of inspection information between accrediting organizations and governmental entities involved in the inspection process. The CAP also has asked CMS to schedule a meeting of stakeholders to discuss ways to improve communication among state and federal oversight agencies and private accrediting bodies, such as the CAP. We understand that CMS intends to convene such a meeting, but has not yet scheduled it. CMS leadership in this effort is essential to developing a protocol with clear requirements for sharing of complaint information among accrediting bodies.

Enhanced Complaint Reporting
Laboratory employees must have easily accessible and effective ways to communicate complaints and other concerns to accrediting organizations, such as the CAP. The College has moved forward with plans to enhance communication with clinical laboratory personnel to ensure their awareness of the College's complaint reporting system. As initial steps in a comprehensive program, we have developed special laboratory signage promoting a dedicated, toll-free telephone number to allow ease of complaint reporting.

Protections for Whistleblowers
We commend the whistleblowers in the MGH case. Without their courageous actions, the state and hospital might never have learned about the testing problems and taken steps to identify recipients of potentially erroneous laboratory results. We believe this case clearly illustrates the need for strong federal protections for whistleblowers, both for the individuals who report problems to governmental or private oversight bodies and to the oversight bodies themselves. Patient safety legislation now before Congress would establish whistleblower protections and we urge Congress to extend those protections to reports to private accrediting organizations.

The College thanks the subcommittee for its interest in ensuring the highest quality laboratory testing. The CAP is firmly committed to working with Congress and federal and state agencies to achieve that goal. We would be happy to respond to any questions.