Published on December 1, 2005
Congressman Cummings' Call for Strengthened Laboratory Oversight
Washington, DC—Today, Congressman Elijah E. Cummings (D-MD), Ranking Member of the Criminal Justice, Drug Policy and Human Resources Subcommittee of the House Committee on Government Reform, commended the College of American Pathologists (CAP)—one of the major private laboratory accrediting bodies—for implementing substantial changes to its laboratory inspection procedures in order to improve the accuracy and integrity of our nation's medical testing system.
Congressman Cummings has taken a leadership role in demanding improved laboratory quality in this country following well-publicized lab testing problems at three medical labs in the Baltimore region. In one instance, a breakdown in oversight led a lab to issue invalid HIV and hepatitis test results to thousands of patients
"Virtually every American undergoes medical testing in the course of receiving medical treatment," Congressman Cummings said. "Public trust that our medical test results are as accurate as they can be is a cornerstone of health care in this country. I applaud the CAP for implementing more stringent laboratory inspection procedures to help ensure that our nation's clinical labs are as safe as possible-both for patients and lab personnel. I urge other accrediting agencies to follow the CAP's lead."
Congressman Cummings worked closely with the CAP as the organization developed procedures to strengthen its accreditation regime.
"Congressman Cummings deserves significant credit for his leadership on laboratory quality; his effort to probe and understand the problems at Maryland General Hospital; and for his work with the laboratory community to avert similar events in the future. Today, the public can take solace in the fact that important changes in the laboratory oversight process are being made that will help to ensure accurate laboratory results and patient safety. The CAP looks forward to collaborating with Congressman Cummings in the future on this important laboratory quality issue," said Thomas M. Sodeman, President of the College of American Pathologists.
The comprehensive changes announced today include:
Development of Knowledge Management System: In order to monitor labs more closely and to ensure safe laboratory practices, the CAP will invest more than $9 million over two years to develop and implement a knowledge management system intended to strengthen the quality of monitoring of its Laboratory Accreditation Program (LAP). The CAP will also conduct validation surveys to assess the effectiveness of these changes to its accreditation process and to detect problems between routine inspections.
New Inspection Techniques and Tools: With patient safety goals in mind, inspections will require more interaction with laboratory personnel as well as direct observation of a lab's testing processes to ensure that actual laboratory practices reflect written guidelines and procedures. The CAP has also issued new checklist questions to better gauge laboratory compliance and assess laboratory director effectiveness.
Mandatory Training for Inspectors: All inspection team leaders will be required to complete CAP training that will emphasize the uniform use of new inspection techniques.
Other changes include the following:
Unannounced Inspections: Beginning in 2006, the CAP will conduct unannounced, routine inspections of laboratories subject to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Whistleblower Reporting and Whistleblower Protections: In October 2004, the CAP instituted a policy that requires accredited laboratories to post information explaining how employees can report complaints on lab practices. This new policy also requires all laboratories to adopt a written policy that standardizes investigations of complaints; requires that all laboratory workers be informed of their organization's complaint procedures; and provides for the revocation of CAP accreditation if workers are harassed or threatened for filing a complaint.
Improved Communication: The CAP has also implemented improved protocols for the communication and sharing of complaint and investigation information among stakeholders with oversight responsibility.
Congressman Cummings said, "I am confident that as these measures are put into place, we will be able to prevent the types of lapses in laboratory testing routines that can lead to inaccurate test results-and I know that in the long run, this vigilance will save lives."
To ensure a continued focus in Congress on clinical laboratory testing, Congressman Cummings introduced the Clinical Laboratory Compliance Improvement Act of 2005, H.R. 686, which would improve laboratory compliance and standards to decrease risks in testing. Along with establishing unannounced inspection visits, the bill would facilitate the disclosure of deficiencies by employees and increase cooperation and accountability among entities involved in the accreditation and monitoring of federally regulated medical labs. The bill would also establish a system for whistleblowers to report lab irregularities.