SOP deficiencies topped blood bank 483s in 1998.

Dear Reader, Failure to have standard operating proce-dures (SOPs), or deficiencies in existing procedures, appears to be the leading problem FDA has found during blood bank inspections. An agency survey of 483s issued to 44 blood banks in three districts found that 31 had SOP violations, Joan Loreng, an FDA Office of Regulatory Affairs headquarters investigator, told a Jan. 13-15 conference in New Orleans, hosted by the University of Rhode Island College of Pharmacy and Pharma Conferences. Loreng, who specializes in biologics, blood bank-ing software and computer systems, said the 31 centers were cited for not having an SOP or having inadequate, incorrect, unapproved, or unavailable SOPs. (See table, page 2). Donor screening and deferral ranked second with 25. Blood plasma collection ranked third at 20. Although Loreng conceded that the citations come from a very small sampling, she termed the results typical of what FDA finds in inspections. The findings may, however, have been skewed by the type of facilities surveyed -- donor centers, autologous donor centers, testing laboratories, blood centers and transfusion centers. Observations from the plasma industry stack up differently. In a study of 483s issued to 30 plasma de-rivative firms inspected from fiscal 1997 (which ended Oct. 1, 1997) through February 1998, QC and QA problems were the leading citation, followed by lack of process validation and cleaning validation. SOPs were third on the list. Cross-department problems are thorniest Referring to blood banks, Loreng told the meet- ing: AErrors that are most problematic in getting to the bottom of, are the errors that cross departmental lines.@ Loreng said this was because investigations might only address the errors by correcting data or errors might be addressed in only one department. Often failures in other departments might be overlooked or the cited errors might not address the reason checks and balances failed to identify the problem sooner, she explained. While FDA=s Investigations Operations Manual spells out that 483s should be based on violations of FDA law and regulations, Loreng said being factual and concise can be very difficult, especially when errors cross depart- mental lines and there are several failures involved in the initial observation. She said the agency must balance these facts and decide the best way to convey the message to the com- pliance officer, blood bank management, the General Accounting Office, Congress and any others concerned. Loreng said this requires the investigator to ask a number of questions, such as how to group observa-tions, for example by citation or by department, to best indicate what the problem might be. The investigator also must try to described the observation factually without being inflammatory, yet not so diplomatically that the seriousness is underplayed.

Sincerely, The Editors P.S. A package of documents from FDA presenta-tions, including Loreng=s talk, plus information on error and accident reporting, donor screening and infectious disease testing, is available for $15 plus retrieval (Doc. 7295W).