Flaws found in lab's tests

THE BALTIMORE SUN

A Baltimore laboratory that handles tens of thousands of patient specimens every day awaits a government inspection to verify that it has addressed problems signaled by several inaccurate tests.

The shortcomings could threaten the lab's certification for reimbursement under Medicare.

None of the failures at Quest Diagnostics Inc.'s lab on Sulphur Spring Road - which involved tests for substances such as thyroid-stimulating hormone and testosterone - resulted in life-threatening conditions, said Wendy Kronmiller, acting director of the state Office of Health Care Quality.

But Kronmiller said her office, which handles complaint inspections for the federal government, considered the three cases it investigated at the lab over the past year or so to be serious because of Quest's failure to ensure that such problems didn't recur.

"In each of the three events, fortunately, we had consumers who knew that something was wrong and had also gotten their own retests," Kronmiller said.

She said the state found no pattern of widespread testing inaccuracies at Quest but did find that the lab had failed to revise its system for identifying, investigating and responding to problems identified in at least three complaints and in state inspections on Oct. 22, 2004, and on April 18 and Sept. 19 last year.

After the September inspection, Kronmiller said, the state government decided to get Quest's attention by threatening to drop it from the Medicare program. The state has since received a fourth complaint, which it is reviewing.

"Physicians make decisions based on lab tests," Kronmiller said in explaining the state's action. "The impact goes beyond the test itself [to] the medications you get, the aid given" and whether more tests are ordered.

Quest revamped its system for dealing with complaints after the government cited it Nov. 16, Quest spokesman Gary Samuels said. It ordered retraining for all 1,400 employees at the lab and began advertising a hot line for patient inquiries (800-532-5932).

The company also centralized its quality monitoring, rather than having various departments handle it, Samuels said.

The lab could be hit with sanctions if inspectors - who plan to return soon for an unannounced visit - find that problems persist.

The laboratory is owned by Quest Diagnostics Inc. of Lyndhurst, N.J., a publicly traded company with more than 30 regional laboratories.

Its Baltimore lab processes specimens sent by doctors and hospitals, and specimens from patients who go to Quest's test centers. The lab handles specimens from Maryland, Washington and Northern Virginia, Samuels said.

"As the leading clinical laboratory in Maryland, we take regulatory compliance and medical compliance very seriously," Samuels said, "and we've worked hard to address these issues."

Among the problems that spurred the state action were:

A mother's complaint that her infant son's Aug. 9, 2005, lab test inaccurately showed elevated ammonia levels in his blood, an indication of potentially disabling liver function problems.

Retesting ordered by the infant's physician turned up normal levels, the state said. But the boy's mother was so upset about the retests - which required additional needle sticks and blood drawing - that she called Quest to complain. She was forwarded to voice mail, and Quest didn't respond, a state report said.

An April 14, 2005, complaint that showed Quest had received two testosterone-level readings from the same blood sample, according to state officials and an inspection report.

The lab didn't identify any problem until it got the complaint. It then "determined that the incorrect results were intermittent, due to a faulty instrument valve."

A March 30, 2005, complaint to the state that a woman with an underactive thyroid - characterized by lethargy -had received widely varying results when the lab tested her levels of thyroid stimulating hormone.

The test results are important because physicians decide how much thyroid-replacement hormone to give a patient based on TSH levels, said William Vaughan, the Office of Health Care Quality's chief nurse.

TSH levels varied widely, even by the hour, but Quest lab workers said the variations were not significant, according to a state report. State inspectors disagreed. "The variations in TSH are significant, and it is not reasonable to say otherwise," a state report quotes an unidentified health care quality official as saying.

It was unclear yesterday what prompted the state's initial inspection in October 2004.

The Quest lab remains accredited by the College of American Pathologists, which last inspected the lab Aug. 17, 2004, and approved it with conditions.

juliana.bell@baltsun.com

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