Hospital lab error re PT/INR a 'system failure' causing 5 deaths

[NRSKarenRN, BSN, RN]

Sunday, August 5, 2001

Hospital lab error a 'system failure'

Executives of the chain that owns St. Agnes also defended the handling of the crisis, saying staff acted quickly.

The blood-test mistakes(PT INR) that may have caused the deaths of five patients at St. Agnes Medical Center were the result of a "system failure" in the South Philadelphia hospital's lab.

By Nancy Phillips, Mark Fazlollah and Josh Goldstein

INQUIRER STAFF WRITERS

The blood-test mistakes that may have caused the deaths of five patients at St. Agnes Medical Center were the result of a "system failure" in the South Philadelphia hospital's lab.

That was how executives of the chain that owns St. Agnes described the episode yesterday. They also defended St. Agnes' handling of the crisis, saying hospital personnel acted quickly last month to identify patients who were in the greatest danger and begin alerting them by phone calls, letters and visits.

"Our first priority was to do all that was necessary to reach all of the patients in harm's way," Richard F. Afable, chief medical officer of Catholic Health East, said in a telephone interview. "This was discovered on Wednesday, July 25, late in the day. . . . We spent most if not all of the first 24 hours notifying patients and doctors."

By then, however, four patients had died - all between June 4 and July 25, the time frame when St. Agnes has said the mistakes occurred and went undetected. The deaths, and another on July 27, are being investigated by the city Medical Examiner's Office to determine whether St. Agnes' mistakes may have been the cause.

The state Health Department is also investigating. "For us, it is a lab-wide problem," department spokesman Richard McGarvey said yesterday. "When systems break down, it can come to an individual, but there should be checks and balances within a lab to prevent that from happening."

In interviews, St. Agnes officials declined to go into much detail about what had happened in the lab, saying the hospital was still doing its own review and was cooperating with government investigators. The hospital has said it compiled a list of 932 patients whose blood tests were in error.

Full report here:

http://inq.philly.com/content/inquirer/2001/08/05/front_page/BLOOD05.htm

Also see:

Wednesday, August 8, 2001

Rules designed to catch blood-test error, state says

Labs must perform daily checks of certain blood-test results. Errors at St. Agnes Medical Center may have caused five deaths.

By Stacey Burling

INQUIRER STAFF WRITER

Laboratories that follow all state and federal regulations would have caught the mistake that led to errors in blood tests for 932 people at St. Agnes Medical Center, state officials said yesterday.

Many of the errors led to overdoses of the blood-thinning drug warfarin and may have caused the death of five patients, hospital officials have told the city's medical examiner.

"The regulations are designed to predict mistakes and prevent them," said Bruce Kleger, director of the Pennsylvania Health Department's Bureau of Laboratories. "We think that if you follow every step of every regulation, something like this shouldn't happen."

Kleger stopped short of saying St. Agnes violated regulations, which include daily checks of blood-test results. The state is not finished with its investigation

Complete story at:

http://inq.philly.com/content/inquirer/2001/08/08/front_page/BLOOD08.htm

While this story was unfolding at a local hospital in my area, I have been caring for a patient with MV replacement, on anticoagulants, who had a simple breast biopsy and developed severe hematoma formation. Slow hematoma resolving with decreased breast size Monday.

Visited patient last Thusday to find increased swelling, strained incision...call came during visit from RN at Drs office re Tuesdays INR result "Oh the printer malfunctioned, just got the lab results today, INR=5.6 ", stated in blaise terms, "will notify her cardiologist". Explained that patient had 2 MORE DAYS of coumadin since test done and suspected bleeding in breast. Just saw surgeon on yesterday. RN unconcerned!!!!!!!!!!

Short story: Coumadin stoped, incision line opened Friday, now daily visit for wound care. Pt saw Cardiologist Mon., Surgeon Tuesday who evacuated some of hematoma....... husband and patient didn't understand why revisit to surgeon needed, until I drilled risk infection and increased bleeding into them!!!!!!

Coumadin NOT a drug to mess around with...thought I'd see this patient 6 visits max; now have made 12 so far and many more to come. Karen

[kids]

I just found this post...I can't believe 'in this day and age' there are still any errors or discrepancies involving Pro-time (its been YEARS since I used that word) -vs- INR. Out here in the backwards Northwest the standard for all but physicians offices that do there own onsite lab work the standard has been the INR.

[NRSKarenRN, BSN, RN]

State fines St. Agnes for errors in lab tests

Part of the $447,500 will be used to improve procedures at the hospital. Mistakes led to three fatal overdoses.

October 24,2001

By Susan FitzGerald

INQUIRER STAFF WRITER

http://inq.philly.com/content/inquirer/2001/10/24/local_news/AGNES24.ht

The state yesterday fined St. Agnes Medical Center nearly a half-million dollars for laboratory testing errors over the summer that resulted in the deaths of three patients and put hundreds of others at risk.

Pennsylvania Department of Health officials said the $447,500 penalty was the largest they ever levied against a hospital - but, in an unusual move, the state will allow St. Agnes to divert a portion of the fine to pay for improved oversight and monitoring of its laboratory and pharmacy services, conduct staff training, and implement community-health initiatives in surrounding South Philadelphia.

Health Secretary Robert S. Zimmerman said the hefty size of the fine spoke to the seriousness of the errors, which involved the incorrect calculation of more than 840 blood-clotting test reports over a 52-day period. The errors led to some overdoses of a powerful anti-clotting drug, Coumadin.

Zimmerman said the alternative payment offer was appropriate because the hospital was forthcoming in reporting the mistake to the state and the affected patients, and cooperated fully with investigators.

"I don't see this as letting them off the hook at all," Zimmerman said. St. Agnes, he said, was being held accountable for its mistakes regardless of "whether the money comes to us or is put into improving services for the community."

Officials at the hospital said in a prepared statement yesterday that they were interested in pursuing the alternative-payment option but might nevertheless appeal the fine.

"Given our full cooperation with the state and other regulatory bodies with regard to this event, and recognizing that we voluntarily and publicly acknowledged the incident upon its discovery, the magnitude of this fine is quite disappointing," said Sister Marge Sullivan, St. Agnes' president and chief executive officer.

Sister Marge said the fine "will be very significant to a community hospital such as St. Agnes Medical Center in in an era of limited resources."

St. Agnes has 30 days to appeal the fine and 10 days to submit to the state a plan on how it would use part of the payment to enhance the quality of its services.

The state Health Department's investigation found that from June 4 to July 25, the hospital's lab incorrectly reported results on a blood-clotting test called Prothrombin Time. The test measures the blood's ability to clot and is generally used to determine the appropriate dose of Coumadin, the brand name for the generic blood-thinning drug warfarin.

According to the Philadelphia Medical Examiner's Office, three patients died from brain hemorrhages because they were given the wrong doses of Coumadin, which can cause serious internal bleeding if too much is taken.

The medical examiner is still investigating a fourth death, a spokesman said yesterday, but so far there is no evidence that it was caused by too much Coumadin.

The state Health Department investigation found that St. Agnes lab workers plugged a wrong number into a formula used to standardize the results so that they are comparable from lab to lab. The St. Agnes workers used the number for a new testing agent they had ordered when, in fact, the same testing agent had been delivered to the lab and was being used in the test.

Routine checks that would have discovered the error were not done, officials said.

The state allowed the hospital to resume doing the test last month after procedural changes were made.

Andrew Wigglesworth, president of the Delaware Valley Healthcare Council, a trade group, said yesterday that he feared the unprecedented size of the state's fine might dissuade other health providers from coming forward to report potential problems.

"This obviously was a tragic set of circumstances for those patients who were injured," Wigglesworth said. But he said the fine seemed excessive given that St. Agnes is a small community hospital and that its administrators had taken the right steps in reporting the problem and fixing it.

St. Agnes, a 152-bed facility on South Broad Street, is part of the Catholic Health East network. According to the Pennsylvania Health Care Cost Containment Council, the hospital lost money on operations in the fiscal year that ended June 30, 2000, with patient revenues of $57 million and total expenses of $61 million.

Zimmerman said St. Agnes' financial picture was not a factor in setting the fine or offering the alternative payment plan.

"We had mortality and morbidity and, repeatedly, procedures that were not followed," Zimmerman said, explaining the rationale for the amount. On the other hand, he said, "St. Agnes is a valuable part of that community and we want to reinforce that."

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Susan FitzGerald's e-mail address is [email protected].