Another FDA complaint filed against Blood Bank of Alaska

Employee alleges dangerous conditions, loss of donors
  • A digital display advertises a free coffee coupon for anyone donating blood.

A Blood Bank of Alaska employee has filed a second complaint to the U.S. Food and Drug Administration about “activities that are unethical, dangerous to donors, and illegal.”

The employee, who has since been placed on administrative leave, was one of the original six who collaborated on a complaint to the FDA in August. Unknown to the original complainants, the unnamed employee provided another more detailed complaint to the FDA shortly after the first.

The Journal could not obtain records of the complaint’s supporting documentation, but according to correspondence between the employee and the Blood Bank of Alaska board of directors, the complainant had brought several of her concerns to BBA leadership and CEO Bob Scanlon before sending the complaint on Sept. 7.

She claims she has been subjected to retaliatory treatment as a result, including harassment and threats of termination.

Among other issues, the employee details that untrained receptionists are giving blood-draw targets to phlebotomists, leading to a situation in which an 84-time donor with a history of single unit donations was given a two-unit blood draw.

By way of explanation, leadership told her each of the blood units was smaller than normal in order to collect more total units, according to a correspondence between her and the board.

Centrally, the complaint criticizes the Blood Bank’s collections practices and worries that an increased demand for blood is backfiring.

“Most importantly for the health and safety of Alaskans, the near constant ‘critical’ appeals for blood have cost BBA many long time donors,” according to a letter to the BBA board of directors dated Sept. 27. “I can demonstrate to any board member willing to observe the data in (donor collection software) that the donor base is being decimated by the extremely intense level of donor contact.

“Alaska does not have a population base that is adequate to replace our many lost donors. Due to these extreme practices, I no longer believe that BBA would be able to generate sufficient donations to respond in a real emergency.”

BBA board vice chairman Dr. Ian Van Tets, a University of Alaska Anchorage professor, asked for the materials submitted to the FDA for each of the complaints to aid the board’s own investigation of employee allegations.

Linda Soriano, the filer of the first complaint, in response, said the FDA advised against sharing the information.

“Regarding your request for the details of the FDA complaint that I developed in collaboration with…current BBA employees, I must decline,” she wrote. “After several conversations with the FDA, it is clear that they do not want us to release any additional information related to the complaint.”

BBA board chairman Ryan York said the board has filed to get the complaints directly from the FDA.

“We believe the FDA is a federal agency, and it has a responsibility under the FOIA (Freedom of Information) Act to share the information it has,” York said. “We’ve had a FOIA request to get a copy of the compliant. If someone says very damaging things about you, it’s only natural in my mind to want to know what was said.”

York said the Blood Bank doesn’t yet have the information to verify any of the allegations listed in the complaint, but that the effort has been ongoing for two weeks in response to the first complaint that was first reported by the Journal on Sept. 14.

“We don’t know a lot yet. We formed a special committee of the board. The allegations are fairly serious,” he said. “There is no group of people who want to get to the bottom of this worse than the board of directors, I can assure you.”

The board has not decided yet whether to make the results of its investigation public, according to York.

“That conversation still needs to happen,” he said. “As of yet, pending results, we are satisfied with the way we’ve acted in the past. Our role is to provide governance, not to provide management.”

York would not comment on the allegations of harassment.

“If there were internal issues like that, they’d be internal. I cannot comment on whether or not any of those issues exist or don’t exist,” he said.

Employee complaints have come from the Blood Bank of Alaska since July following a blood export agreement that began May 1 and reports detailed in the Journal of dangerous shortages at major Anchorage medical centers.

After moving into its $45.7 million, 57,000-square foot building earlier this year, the Blood Bank of Alaska entered an agreement with LifeStream, a California blood center, to export 100 units of blood per week, all the while ramping up recruitment for more donors in Alaska.

The building was funded with $32.8 million from the state capital budget, an $8.5 million loan from the Alaska Industrial Development and Export Authority, and a $3 million donation from ConocoPhillips.

In September, a group of Blood Bank of Alaska employees filed the first complaint with the FDA charging the BBA leadership with mismanagement and financial impropriety leading to dangerous donor conditions and blood shortages.

Linda Soriano, the Blood Bank’s former development manager, linked mismanagement to the costs of BBA’s new building in the first FDA complaint.

In prior interviews, Blood Bank board members and CEO Bob Scanlon have insisted that such export agreements are commonplace in the industry. No Alaska hospitals, they said, have been shorted on blood supply.

They said the blood export agreement with LifeStream has no connection to the building’s finances, but is simply a way for the BBA to more effectively manage blood to maximize efficiency.

BBA leadership responded to the first complaint with a statement on Sept. 16 that it would launch its own investigation, insisting it takes the allegations seriously.

DJ Summers can be reached at [email protected].

Updated: 
11/06/2016 - 5:16pm

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