Blood Bank Setup Faulted in HIV-Tainted Transfusion : Health: County, federal reports cited serious problems at King/Drew. Patient was infected last year.
Aleta J. Clemons entered the county’s Martin Luther King Jr./Drew Medical Center for a routine hysterectomy last year, without any way of knowing of the systemic problems in the hospital’s blood bank. She walked out with the virus that causes AIDS.
In the course of her surgical procedure, Clemons was given a transfusion of a unit of blood that had tested HIV-positive and had been set aside for quarantine. A mother of three young children, she is already showing symptoms of the fatal disease.
Clemons’ $1.5-million-plus lawsuit against the hospital and county has been tentatively settled for $450,000, pending approval today by the county Board of Supervisors.
In their defense, administrators at the busy public hospital near Watts described the incident as a tragic but isolated event that was the result of a horrific confluence of flukes.
“There are problems with blood banks everywhere,” said Dr. Edward Savage, the hospital’s medical director.
“I believe it to be an isolated incident,” said Mary Jung, the county’s acting director of health services. “As soon as we found out about it, we took immediate action.”
But the county’s own documents, as well as federal inspection and investigatory reports, paint a picture of a blood services system so riddled with problems that Clemons’ receipt of the HIV-tainted blood was, in effect, a tragedy waiting to happen--and one that county officials were warned about well in advance.
A host of required safeguards designed to protect Clemons and others from the accidental release of tainted blood had been overlooked or circumvented or were not in place at all, according to citations from the federal Food and Drug Administration and the results of a county Department of Health Services investigation done in the wake of Clemons’ transfusion.
The blood bank suffered from severe understaffing, inadequate training of employees, poor management and oversight, miscommunication and bickering among leadership and failure to adhere to some of the most basic safety requirements, according to an investigative report prepared by the Department of Health Services and other documents, including Civil Service Commission records.
“I’ve never seen anything like it,” said Fred Leaf, chief investigator with the health department’s inspection and audit division. “There is no question but that this program was seriously deficient, with chronic, systemic operational problems.”
The head of the blood bank and other management staff, for instance, were “unaware” of many basic regulations and safety guidelines and they did not have on hand most of the appropriate--and legally required--rules, regulations, guidelines, federal informational updates and reference materials “designed to prevent catastrophic errors such as that which occurred,” the county report concluded.
And Clemons was not the only person to receive blood that had tested positive for HIV in June 1994, at King/Drew. Another unit, later determined to be a false positive, was used in a transfusion for another patient through the same combination of human error and lack of safeguards, county investigators found. Some hospital officials also had changed the workings of the blood bank computer records to hide the HIV status of blood to protect donor confidentiality, yet they never told many of the employees who needed to know--including the nurse who let the blood go, county documents show.
Warnings, however, were sounded well before Clemons’ ill-fated transfusion.
Seven months earlier, blood bank supervisor Novella Howard complained in a letter to her supervisors that the hospital’s overall transfusion service was far too understaffed for such a busy trauma center. It was not up to speed, she said, with the many regulatory changes that had occurred in the complex field of blood safety, especially with the increasing use of computers and new technology.
“Our laboratory,” Howard warned, “remains in the dark ages as far as staffing and progress in the transfusion service is concerned. . . . This has to stop.”
But Clemons, 44, didn’t know any of that. Nor was she told that she could have given her own blood in the weeks before her scheduled operation, a safety precaution strongly encouraged by most hospitals, she alleges in the lawsuit she filed against the hospital and county.
In the negotiations aimed at settling the case, the subject of problems at the blood bank did not come up, and the county officially will not have to admit wrongdoing, or even negligence, said Mark Grayson, Clemons’ lawyer.
Hospital officials also say they have fixed most problems at the blood bank, and that they have shut down at least temporarily the part of the blood bank that draws, tests and labels blood from donors.
Among the problems county and federal investigators said they found:
* Lack of fail-safe measures. Basic safeguards were ignored, such as having a second person double-check the safety of the blood supply. And there was no system in place to account for each unit of tainted blood, to make sure it was disposed of and not accidentally released.
* Bad management. Administrators and employees alike did not know they were required to have an overall “quality assurance” system in place, which helped foster conditions that allowed for serious problems in the use of the computers that run the blood bank.
* Lack of training. Training of employees was described as inadequate, with staff not trained to verify some diseases of donors.
* Bad record-keeping. Investigators found that the blood bank had failed to maintain adequate records regarding the collection, processing and disposition of each unit of blood so it could be traced back to the point of origin. Some lab reports listed the 17th, and even the 25th month of the year as the test date.
Those employees singled out or disciplined acknowledged that long-standing problems led to the release of HIV-positive blood, but each of them pointed the finger of blame at someone else.
A lawyer for Freddie Brown, the veteran nurse who ultimately let the blood in both cases go into circulation after wrongly assuming it was negative, defended his client at a Civil Service hearing in May by saying “there were no enforced policies with respect to the release of the blood.”
Brown “often had to rely on oral communication to know whether or not blood should be quarantined and subsequently destroyed,” said lawyer Ollie P. Manago. Brown, once named county nurse of the year, also said--like other hospital employees--"that it was not until this unfortunate incident [Clemons’ transfusion] occurred that more safeguards were implemented to protect patients from receiving contaminated blood.”
Although hospital officials had recommended firing him, Brown ultimately was allowed to resign from the county, and to have all mention of the incident expunged from his personnel records, Civil Service Commission records show.
Supervisor Howard, laboratory coordinator Edith Nealy and Dr. William Temple, the overall head of transfusion services, all were suspended and transferred out of the blood bank, Civil Service records and other county documents show.
Temple was sharply criticized for a lack of leadership and involvement in daily operations of the blood bank, Civil Service documents and internal memos show. His supervisors later said that his lack of leadership contributed to numerous breaches of state and federal laws governing blood banks, county documents show.
What’s more, hospital officials said, Temple had failed to tell his supervisors about ongoing problems, instead assuring them “that everything was all right in the Blood Bank, when in fact it was not,” according to one internal memo.
Temple, who was ultimately suspended for 30 days and demoted, said in a letter to his supervisors that he was given too much responsibility, especially for his level of education and training. He also said he had long complained that the hospital needed to hire a full-time blood bank pathologist.
Temple said Monday, “I really can’t comment, other than to say that everyone was doing the best they could with the usual limitations that exist in a county facility that was underfunded. Unfortunately, the county’s and the FDA’s investigations, their interpretations of where the fault lies, and what broke down, are not mine.”
Nealy and Howard each said they were not to blame and said the errors resulted from poor communication and other structural problems in the lab.
Employees had long complained about staff shortages, especially lack of people trained to work with complicated blood testing procedures.
The American Assn. of Blood Banks, which reviews blood bank operations but has no regulatory authority, also had uncovered problems at the blood bank. After the association cited the blood bank in 1994 for many deficiencies, including the labeling of its blood, hospital officials promised corrective action by late that May--one month before Clemons’ transfusion. “We need to do this,” one hospital employee noted next to the labeling citation on the hospital’s corrective action plan.
Most of those problems, however, only came to the attention of high-level county administrators after Clemons’ transfusion, when investigators from the health department and the FDA swooped in to find out what went wrong.
When the FDA came to investigate in November 1994, some hospital employees were “evasive and brusque,” records show. Temple even “picked a fight” with some FDA investigators, according to internal county documents, including an apology letter sent to the FDA by county health officials. Temple said Monday that FDA investigators were harassing him.
Ultimately, the FDA concluded that several specific problems were to blame for the transfusion. And they found far more substantive problems as well in the six days they spent at the medical center late last year, and issued a list of citations that criticized nearly the entire operation on many levels.
FDA District Director Elaine C. Messa then sent a warning letter last January, citing the blood bank for a host of violations, including failure to make sure its computers were running correctly, and failure to adequately train personnel or advise them of changes in the computer’s record-keeping system.
Messa also cited the blood bank for not having a basic “quality assurance program to, among other things, prevent errors from occurring and investigate any that have occurred.”
If such problems were not corrected immediately, Messa said, federal authorities could seize control of the blood bank, or enjoin the hospital from running it.
Hospital officials responded by saying they would correct all the deficiencies. But by May of 1995, the hospital instead temporarily closed the donor room.
And after FDA investigators made a surprise inspection again in September, the embattled health department--struggling with its worst fiscal crisis ever--indicated it may keep the donor operation shut for good because of high costs.
The blood bank remains open, but it now gets its blood from other sources, such as the Red Cross, hospital officials said.