Blood Bank officials say FDA found no evidence to back complaints
Complaints aired last year against the Blood Bank of Alaska are unfounded, according to bank leaders, but the results of the Food and Drug Administration investigation aren’t yet public.
The FDA visited the Blood Bank of Alaska from March 6 through March 14. During the course of the inspection, BBA leaders said the governing agency found nothing to support a series of misconduct allegations brought against them by several former and current employees in two separate complaints to the FDA in 2016.
BBA leadership said the results prove what they have said all along.
“The results clearly showed that we crossed all our Ts and dotted our Is and did everything right,” said CEO Bob Scanlon.
Last August, two sets of employees filed two separate complaints with the FDA, alleging that BBA was practicing improper and sometimes dangerous blood drawing techniques and inventory controls.
They did so as the result of having overextended themselves for their new building on Airport Heights Road, one complaint alleged, for which they needed to sell blood to California blood bank LifeStream. This led to overdrawing and over recruiting donors and a dangerous blood shortage in the summer of 2016, the complaint asserted.
Board of directors chairman Ryan York and CEO Scanlon have consistently denied the allegations. Last fall, they mounted an internal investigation, performed by several of the bank’s board members, that concluded none of the accusations had any merit. York welcomed the FDA’s audit as confirmation.
“The results of the investigation showed overwhelmingly that the accusations were unfounded,” he said in the release. “The FDA is the highest law in the land for blood banks and now they have independently confirmed the results of the internal investigation. We all knew all along this would be the case but it’s nice to now have their results finalized.”
Due to FDA policies, audit specifics are an unknown quantity.
According to Scanlon, the audit carried out was routine, not specifically geared towards addressing previous complaints filed against the blood bank. During the 2016 press conference revealing the results of the internal investigation, Scanlon had said he spoke with the FDA about the complaints. At the time, he said they had no interest in pursuing a special audit.
“Based upon the knowledge they had, they did not see anything of a nature that would threaten the safety, purity, or potency of the blood supply,” he said. “That’s why they didn’t appear immediately.”
At the time, the FDA would not comment on whether or not it was planning or would carry out a special investigation.
If the FDA’s most recent audit results are indeed finalized and do indeed disprove the complaints against the blood bank, the public can’t know until further notice. Though BBA praised the finalized results as verifying its own investigation, the FDA is characteristically mum on the issue.
“The FDA, by policy, does not discuss possible or ongoing investigations,” wrote FDA spokesperson Lyndsay Meyer.
Scanlon acknowledges that without a visible report from the FDA the public might still have questions. He said because BBA didn’t receive any comments of concern from the FDA, the bank wasn’t provided anything in writing to show the Journal as evidence that the complaints have no basis.
“Once we receive the letter I’ll ask them what the protocol is,” he said.
The FDA will have addressed some, but not all, of the complaints alleged by former and current employees. Annual FDA inspections of blood banks look at operational issues, including blood drawing practices and storage code requirements. On these points, Scanlon said the blood bank brought up no concerns.
“This is the most detailed type of audit the FDA does,” Scanlon said. “They take possession of all our procedures. They then look at all the training records. They will then observe the staff as they perform their functions. They’ll check things like maintenance records on our equipment. They’ll check temperature reading on equipment, everything.”
However, Scanlon also acknowledged not all of the complaints would be under the FDA’s authority. Neither the FDA nor the American Association of Blood Banks monitor or mandate blood inventory levels — the issue that served as a catalyst for BBA attention in 2016. Further, whatever financial troubles are alleged in Soriano’s complaint are a matter of their own.
“They would not address or make a determination on the volume of blood that’s on hand,” he said, and also that “financials are under the purview of the blood bank’s individual auditor.”
This loops into an earlier issue with the blood bank’s financial auditors, Anchorage firm Swalling and Associates, which used financial information from before BBA’s export agreement with California blood bank LifeStream, the alleged source of inventory problems in Soriano’s complaint.
DJ Summers is a correspondent for the Journal. He can be reached at firstname.lastname@example.org.