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Faulty Philly Lab Procedures Cited
By MICHAEL RUBINKAM
.c The Associated Press
PHILADELPHIA (AP) - A hospital laboratory used the wrong form of a chemical in conducting a routine test, leading hundreds of patients to receive incorrect doses of a blood-thinning medication and possibly causing five deaths, the state health department said Wednesday.
Officials at St. Agnes Medical Center have said 932 patients may have received incorrect doses of the anticoagulant warfarin, better known by the brand name Coumadin, between June 4 and July 25.
Warfarin is prescribed for patients with artificial heart valves, abnormal heart rhythms and other conditions that increase the risk of blood clots that could lead to a heart attack or a stroke. But too high a dosage can be dangerous.
The health department said the lab error involved the test that is typically used to monitor patients using warfarin.
``People got wrong results and medication was adjusted based on these incorrect results. They were given a higher dosage,'' said Dr. Bruce Kleger, director of the Bureau of Laboratories for the state health department.
Hospital officials did not immediately return messages seeking comment Wednesday.
The Philadelphia medical examiner's office has been investigating the deaths of five people the hospital said may have died as a result of the errors. It was expected to release its findings later Wednesday.
St. Agnes voluntarily stopped doing the test analysis soon after the errors were discovered and has been sending the work to another lab.
The health department investigation centered on the main chemical used in the prothrombin test, fibrinogen, which is added to blood in a machine and causes it to clot.
The hospital ordered what it thought was a more sensitive version of fibrinogen, but instead received a less sensitive version, according to Kleger. The lab did not discover the error and then used the wrong formula to calculate the clotting of patients' blood, he said.
The health department investigation found errors in the way the hospital ordered fibrinogen and also faulted the lab's quality assurance program since it failed to detect the mistake.
The health department also contacted U.S. Food and Drug Administration officials about concerns over the way fibrinogen is labeled.
The department said it will conduct unannounced checks of St. Agnes' lab procedures over the next year to make sure the hospital is in compliance.
The laboratory has 10 days to fix the problems or risk losing authorization to perform clinical diagnostic testing.
AP-NY-08-15-01 1253EDT
Faulty Philly Lab Procedures Cited
By MICHAEL RUBINKAM
.c The Associated Press
PHILADELPHIA (AP) - A hospital laboratory used the wrong form of a chemical in conducting a routine test, leading hundreds of patients to receive incorrect doses of a blood-thinning medication and possibly causing five deaths, the state health department said Wednesday.
Officials at St. Agnes Medical Center have said 932 patients may have received incorrect doses of the anticoagulant warfarin, better known by the brand name Coumadin, between June 4 and July 25.
Warfarin is prescribed for patients with artificial heart valves, abnormal heart rhythms and other conditions that increase the risk of blood clots that could lead to a heart attack or a stroke. But too high a dosage can be dangerous.
The health department said the lab error involved the test that is typically used to monitor patients using warfarin.
``People got wrong results and medication was adjusted based on these incorrect results. They were given a higher dosage,'' said Dr. Bruce Kleger, director of the Bureau of Laboratories for the state health department.
Hospital officials did not immediately return messages seeking comment Wednesday.
The Philadelphia medical examiner's office has been investigating the deaths of five people the hospital said may have died as a result of the errors. It was expected to release its findings later Wednesday.
St. Agnes voluntarily stopped doing the test analysis soon after the errors were discovered and has been sending the work to another lab.
The health department investigation centered on the main chemical used in the prothrombin test, fibrinogen, which is added to blood in a machine and causes it to clot.
The hospital ordered what it thought was a more sensitive version of fibrinogen, but instead received a less sensitive version, according to Kleger. The lab did not discover the error and then used the wrong formula to calculate the clotting of patients' blood, he said.
The health department investigation found errors in the way the hospital ordered fibrinogen and also faulted the lab's quality assurance program since it failed to detect the mistake.
The health department also contacted U.S. Food and Drug Administration officials about concerns over the way fibrinogen is labeled.
The department said it will conduct unannounced checks of St. Agnes' lab procedures over the next year to make sure the hospital is in compliance.
The laboratory has 10 days to fix the problems or risk losing authorization to perform clinical diagnostic testing.
AP-NY-08-15-01 1253EDT
