Patient Deaths at NIH Lead to Blood Banking Reforms

July 25 marks the anniversary of a blood transfusion error between two federal health agencies in 2011 that was implicated in the deaths of two patients at the National Institutes of Health (NIH) in Bethesda, Md.

Two patients being treated at NIH received transfusions of platelets from a single donor that were contaminated with the dangerous gram negative bacteria Morganella morganii. Both patients died, one within a few days and the other after six weeks of intense treatment, which never overcame the shock to the patient’s system of receiving a direct injection of bacteria into his bloodstream.

The originating source of the platelets – and where the actual contamination occurred – was the blood bank facility of the former Walter Reed Army Medical Center (WRAMC) in Washington, D.C. The incident occurred as the WRAMC blood bank was in the process of being shut down and activity transferred to the National Naval Medical Center (NNMC) in Bethesda, although the closure did not appear to have anything to do with this event.

As the medical facility receiving the contaminated platelets, the NIH does not routinely test incoming blood products for safety but relies on the originating blood bank to do the necessary testing.

It was not until after the fatal infusion of the contaminated platelets that laboratory testing by NIH revealed that the platelets had been contaminated with the Morganella bacteria.

The two patients receiving the contaminated platelets went into immediate and profound septic shock.

One, Richard H. Bowen, Jr. (age 34 at the time) died 44 days after receiving the contaminated platelets. Bowen was the partner of Darryl A. Wahlstrom, who is co-authoring thisblog with attorney Patrick Malone, who represented Bowen’s estate and Wahlstrom in a lawsuit against the federal government.

The government admitted that the contaminated platelets sent both patients into shock but disputed the role of the transfusion in causing their deaths.

The root cause of this event is publicly documented in the “Joint Statement of Material Facts Not in Dispute” from court papers filed by the government in the Bowen/Wahlstrom lawsuit, Civil Action No. 12-1225, in the U.S. District Court, District of Columbia.

The safety testing of the platelets included two separates tests, one for bacterial contamination and a second test for the presence of viruses.

The platelets tested positive for contamination with the bacterial test. Due to the presence of the Morganella bacteria, the bag of platelets was deemed unsafe and given a quarantine status in the electronic system (database) of the blood bank.

During the testing process, an operator observed that the results from the second (virology) test were incomplete and erroneously attributed the quarantine status of the platelets to the fact that test results were still pending, and thus removed the quarantine status once the virus test came back negative.

Blood bank operators then indicated that the platelets were safe for infusion and released them for delivery to NIH without looking back at the previous positive bacterial testing.

The bag containing these contaminated platelets was then sent from the blood bank at WRAMC to the NIH Clinical Center’s Department of Transfusion Medicine. The volume of platelets delivered to the NIH was split and administered separately to two different patients, with terrible consequences for both of them.

Any system intended to protect the health and well-being of patients must be designed to foresee and block the kind of human error that happened here. In this case, blood banking officials at the new blood bank at the combined Army/Navy facility in Bethesda, now known as Walter Reed National Military Medical Center, admitted to Wahlstrom in the course of the lawsuit that the old procedure at WRAMC was deficient.

They changed the procedure so that once any blood tests positive for any kind of contamination, the bag of blood must be labeled with a permanent sticker “contaminated, do not use,” and the bag must be physically isolated from other blood intended for human use.

Under the old policy, the quarantine was in only a computer listing that was easy to overlook. If such a physical quarantine policy had been in place in 2011 at WRAMC, the incident that infected the two patients at the NIH in July 2011 would never have occurred, because the contaminated platelets would have been isolated as soon as the test came back positive for Morganella bacteria.

The study of blood safety is referred to as hemovigilance, from the roots “viligare” (to be watchful) and “hemo” (blood). The reason hemovigilance is so important isbecause lethal repercussions can occur if the system and procedures lead to outcomes (contaminated blood products) that deviate from the ones for which the system is designed (safe blood).

Great strides in the safety of blood products and transfusion procedures have been made. Fatal occurrences are rare. Medical providers, however, must remain vigilant to ensure improvements continue to be made and that systems, procedures, and human involvement are designed and integrated that prevent avoidable errors from occurring in the first place.

Richard Bowen Jr. had advanced, stage IV metastatic gastric cancer at the time he received the contaminated platelets. This was a few days after he had undergone extensive, experimental surgery at the clinical branch of the NIH, intended to measure whether such surgery could prolong life. Some patients in the experimental group were still alive three-plus years after their treatment. Whether that would have happened for Bowen can never be known.

But what is certain is that the contaminated platelets snuffed out any hope he had for meaningful survival.

Patients come to a world-class facility like the National Institutes of Health in search of hope and to receive the best medical care possible for their condition. If any medical institution should stand as an exemplar of quality and safety, it should be the NIH. The associated Walter Reed National Medical Center, across the street from the NIH in Bethesda, also should be a beacon of high quality care for our uniformed service members and all those touched by military medical care.

We hope both the NIH and the military have learned the lessons from this case about the importance of vigilance in protecting the safety of blood supply that sick patients depend on.

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