Congressman Elijah E. Cummings Proudly Representing Maryland's 7th District

FOR IMMEDIATE RELEASE
June 27, 2006

FOR ADDITIONAL INFORMATION:
Devika Koppikar
(202) 225-4741 or (202) 225-4025
Trudy Perkins
(410) 685-9199 or (202) 225-4741
Mike Christianson
(410) 685-9199 or (202) 225-9876

Washington, D.C. -- Today, U.S. Congressman Elijah E. Cummings, Ranking Member of the House Government Reform Subcommittee on Criminal Justice, Drug Policy and Human Resources was joined by Subcommittee Chairman Mark Souder (R-Ind.) to release the Government Accountability Office (GAO) report entitled, “Clinical Lab Quality.”

The report is available in PDF format.

In October 2004, Congressmen Cummings and Souder, along with U.S. Senator Charles Grassley (R-Iowa) made a request to the GAO to investigate the performance of the federal regulatory system with regards to medical laboratory testing. The request was made following two congressional hearings that examined reports that medical laboratories in Maryland and other places around the nation had given questionable lab test results to patients due to faulty lab equipment. At today’s press conference, Congressman Cummings made the following statement after releasing the report.

“We're here today to release the GAO report entitled, "Clinical Lab Quality," which examines laboratories across the country to determine whether they are in compliance with federal regulations.

“Clinical labs are a crucial aspect of our health care system:

• A full 70 percent of medical decisions are affected by lab results. And,

• Virtually every American undergoes testing at some point, relying on the accuracy of those tests to receive appropriate medical care and treatment.

“This report represents the culmination of several investigations, including two hearings held by the Subcommittee on Criminal Justice, Drug Policy and Human Resources, of which I am the Ranking Member.

“I would like to thank my colleague, Subcommittee Chairman Souder, for his dedication to this issue, and for requesting, along with myself and Sen. Charles Grassley, the GAO report that we are releasing here today.

“Our interest in this issue was piqued by the distressing story of Kristin Turner, a young lab technician at Maryland General Hospital who contracted HIV and Hepatitis C in 2003 when the machine she was using malfunctioned, splattering her with infected blood. Sadly, the injustice imposed on Ms. Turner did not end there.

“She had long been horrified by the conditions of the lab, being an outspoken critic even before she was infected with HIV and Hepatitis C. Ms. Turner's efforts to blow the whistle on these injustices only increased after the incident­and she was rewarded for her efforts by losing her job.

“In fact, it was only because of Ms. Turner's whistle­blowing that state officials ever discovered that over a 14-month period more than 2,000 patients were issued invalid HIV and Hepatitis C test results by Maryland General Hospital. It was only because of her selflessness that we discovered that there were serious lapses in our nation's clinical laboratory oversight system. How could we have so blindly ignored the cries of this determined whistleblower?

“We have since worked with the College of American Pathologists, Centers for Medicaid and Medicare Services (CMS), Maryland General Hospital and state officials to fix these problems, by implementing and enforcing a stricter set of lab oversight rules to prevent any such reoccurrence.

“But the story of what happened in my home state of Maryland made those of us in the federal government question whether this public health problem might be more widespread: Could the fates of people across the country be the same as Ms. Turner and those 2,000 patients? We felt that we had an obligation to find out.

“That's why I requested that the GAO investigate the quality of clinical labs nationwide. Unfortunately, its findings are less than encouraging.

“The GAO says it cannot conduct a system­wide analysis because the necessary data does not exist­the Centers for Medicaid and Medicare Services changed its oversight process in 2004, making it impossible to compare standards.

“What the GAO did find, however, were the same shortcomings we discovered in Congressional hearings:

• Would­be whistleblowers are discouraged from reporting lab failures for fear of retaliation from lab workers;

• A focus on so­called "education" over imposing sanctions by inspectors makes masking deficiencies easier;

• And the collegial composition of lab inspection oversight teams often presents a conflict of interest.

GAO also makes a series of 13 recommendations for how lab oversight could be improved, including:

• Standardizing the reporting of survey deficiencies to allow for meaningful analysis; and

• Working with accrediting organizations to ensure that educational efforts do not preclude appropriate regulation.

“CMS concurred with 11 of GAO's recommendations and noted that they will serve to provide greater insight to increasing and reinforcing its oversight.

“Before the GAO finished its study, I introduced the "Clinical Laboratory Compliance Improvement Act" (currently H.R. 686) in the 108th and 109th Congresses. The bill would institute many of the reforms GAO recommended, including: establishing whistleblower protections for employees of clinical labs; requiring labs to post signs to encourage whistleblowers to come forward; requiring reporting to the Department of Health and Human Services; and requiring that accreditation surveys be unannounced.

“I look forward to working with my colleagues on both sides of the aisle to address this vital public health issue.

“Thank you again for following this critical and poignant issue.”

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