FDA Found Problems at Red Cross’ New Philly Facility

 

Photo by Alejandro Alvarez/Philadelphia Inquirer.

Philadelphia Inquirer | Sept. 1, 2011 — Eighteen months ago, the American Red Cross finished setting up new centers in Philadelphia and Charlotte, N.C., to consolidate a crucial part of its blood business – making sure donated blood is safe and recalling it if there is any doubt.

By consolidating these duties, which had been performed in each of 35 regional offices, the Red Cross hoped to increase compliance with government safety rules, streamline operations, and reduce costs.

But the Food and Drug Administration’s first – and so far only – inspection last fall found dysfunction and disorder at the new centers.

Both sites had “chronic” understaffing, inadequate training, quality-assurance lapses, and ineffective management, even though the consolidation had been done gradually over two years ending in March 2010, according to inspectors for the FDA, which regulates the collection and screening of blood.

The Red Cross says it has since addressed many of the problems at the new “donor and client support centers.”

“The Red Cross and the FDA share a common goal of the safest blood supply possible,” Red Cross officials wrote in answer to Inquirer questions submitted to spokesman Roger K. Lowe. “We have made significant progress in improving our regulatory compliance” through “system-wide changes to our donor management operations.”

The FDA declined to discuss the inspection report, the possibility of fines, or when it would reinspect the support centers. Inspections are done annually but are unannounced; the report was obtained through a Freedom of Information Act request and is being publicized here for the first time.

Since 1993, the Red Cross has been under a federal court order to improve the way it collects, processes, and tracks blood. The order, called a consent decree, was amended in 2003. Since then, the FDA has fined the Red Cross $37 million for persistent lapses.

Examples of progress

The nonprofit, which has to cover its expenses with revenues, says the fines have added about 50 cents per blood product to the 76 million units it has sold over the last eight years.

Although she would not comment on the inspection report, Mary Malarkey, an FDA compliance office director, said the Red Cross had made progress toward complying with the consent decree.

“Standardization and consolidation of testing labs and improved oversight of the biomedical headquarters are examples of progress we’ve seen,” Malarkey said.

“There is still work to be done,” she said. “The progress has been slow.”

The Red Cross is by far the nation’s biggest blood supplier, controlling 43 percent of the stock of red cells, plasma, platelets, and other components. It’s a complex, high-stakes enterprise, given the nature of blood products: They have no substitutes, a limited shelf-life ranging from five days to about a year, and the potential to gravely harm a transfusion recipient.

The donor and client support centers work to avert or detect harmful transfusions by:

  • Monitoring donor blood test results and other eligibility information.
  • Maintaining a database of the 12 percent of donors who are temporarily or permanently “deferred.” (A donor who has traveled to a country where malaria is endemic would be temporarily deferred, while a donor whose blood tests positive for HIV would be permanently deferred.)
  • Doing all notifications and investigations related to withdrawing unsuitable blood products. This includes not only blood that tests positive for HIV or eight other infectious diseases but also products that are unlikely to cause harm, such as blood donated by someone who belatedly reports traveling to a malarial region.
  • Investigating possible transfusion-related complications and donor injuries.

‘Large hubs’

The Red Cross’ senior management chose to put the support centers in Philadelphia and Charlotte for several reasons.

“We selected locations with a large number of staff already experienced in donor-client services,” officials wrote. “Philadelphia and Charlotte are also large hubs of operation for other branches of biomedical services” such as donor blood testing.

Experienced or not, the transition did not go smoothly, particularly in Philadelphia, the smaller of the two new support centers.

FDA inspectors who visited the facility at 700 Spring Garden St. found “staff was struggling and there was no support from management . . . and planning was not adequate.”

Philadelphia’s quality-assurance staff “had no donor management experience . . . and was not fully trained,” the inspection report said.

The support center’s workers are not unionized, but their labor problems sound much like complaints from union employees at numerous regional blood services centers, including the Red Cross’ Penn-Jersey center, which serves Southeastern Pennsylvania and New Jersey. In May, for example, Penn-Jersey nurses and other workers staged a three-week strike to protest what they saw as inadequate staffing levels, inconsistent training, and unreasonably long shifts, among other contract issues.

Jeanne Otersen, a spokeswoman for the Health Professionals and Allied Employees, said the union and Penn-Jersey officials were negotiating, but they have not made much progress. She said union members have voted to authorize a strike after the contract expires Sept. 15.

Besides labor problems, both donor management centers were criticized by inspectors for persistently taking too long to launch investigations, update databases, and close cases.

The inspectors did not find that the problems led to the distribution or use of infectious blood products, or to donations by deferred donors.

Backlog

Their report was based on a Philadelphia site visit, plus a review of internal audits and assessments conducted by Red Cross officials.

Inspectors noted a backlog of 18,000 “donor management cases” – such as notifying hospitals about unsuitable blood or counseling a donor whose blood tested positive for an infectious disease – that needed a final review of paperwork to be closed.

In addition, nearly 5,000 reports of blood donors who had bad reactions such as fainting or bruising were awaiting a final quality-assurance review to be closed.

In their response to The Inquirer, Red Cross officials said they were already aware of many of these “challenges” and were taking corrective actions when the FDA conducted its inspection last September and October.

“However, the FDA inspection identified other underlying issues” that prompted “broader corrective actions,” Red Cross officials wrote.

Among those actions:

  • Charlotte’s staffing was increased 35 percent, to 375 employees. Philadelphia’s was increased 40 percent, to 110 employees.
  • Training, supervision, and “mentoring” have been increased.
  • Highly experienced quality-assurance managers and a quality auditor have been assigned to the support centers.
  • The backlog of 18,000 donor management cases has been reduced 95 percent, and is now at “normal expected levels.”
  • The backlog of 5,000 donor injury reports has been eliminated. As of last month, 40 donor counselors had 143 cases, all being managed within time requirements.

“We take any and all problems seriously and have an in-depth process for investigating and correcting these issues,” Red Cross officials wrote.

Read the full article at Philly.com.

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