Medical facility fixes flaws


A Baltimore medical laboratory cited in November after distributing inaccurate test results has corrected major problems, but it still has less serious deficiencies, including a lack of staff to complete quality-control paperwork, government inspectors say.

A recent inspection showed that technicians at Quest Diagnostics Inc. on Sulphur Spring Road appeared to be checking its machines properly to ensure that they dispensed accurate test results, said Wendy Kronmiller, acting director of the state's Office of Health Care Quality.

But state officials, acting on behalf of the federal government, nonetheless cited the lab for additional deficiencies Thursday after a weeklong inspection.

Among other problems, inspectors found that Quest's automated chemistry department didn't have enough employees to allow time for proper documentation.

"People were doing the work fine," Kronmiller said, noting that the department's inspectors audited some test results to check for accuracy. But she said that technicians' actions weren't documented.

Kronmiller said the problems weren't serious enough to continue the state's threat to withdraw the lab's right to bill Medicare for its work, a threat the state made when it cited the lab Nov. 16.

Instead, she said, Quest will have to submit plans for fixing the latest problems and submit to another inspection.

Quest spokeswoman Jennifer Somers said the company learned Feb. 3, shortly after the last inspection was finished, that the state didn't plan to pursue revocation of the lab's Medicare billing status. But, she said, "We take [any] violations extremely seriously, and we are currently preparing a response that we plan to submit Feb. 28."

Quest Diagnostics Inc. of Lyndhurst, N.J., is a publicly traded company with more than 30 regional laboratories. Every day, its Baltimore lab processes tens of thousands of blood, tissue and other specimen samples sent by doctors and hospitals, along with specimens from patients who go to Quest's test centers. The lab handles work from Maryland, Washington and Northern Virginia.

The lab has made changes since Nov. 16, when the state said it had failed to revise a faulty system for identifying, investigating and responding to problems. It has, for example, retrained its staff and hired a new quality expert to oversee the automated chemistry department.

The original problems became apparent after the lab dispensed several inaccurate tests last year, as well as after state inspections Oct. 22, 2004, April 18, 2005, and Sept. 19, 2005.

None of the failures - which involved tests for substances such as thyroid-stimulating hormone and testosterone - resulted in life-threatening consequences, Kronmiller has said. The state found no similar failures in its recent inspection.

Surveyors from the College of American Pathologists, which accredits the lab, accompanied the state on the most recent inspection. CAP has yet to issue its accreditation decision, but a spokesman said, "our findings were consistent with the findings of the state of Maryland."

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