Deferral, screening, SOPs trouble plasma center.

Bio-Medics, Rexburg, ID, Seattle District.

Despite a prompt response to inspection findings last February, FDA issued a warning letter April 14 to Compton, CA-based Bio-Medics for donor screening and deferral deviations and documentation problems at its Rexburg, ID, plasmapheresis center. Several of the observations indicated that staff failed to adhere to SOPs.

Investigator Dolores Price cited a number of lapses in handling donors and equipment. For instance, technicians failed to defer donors who had experienced more than one loss of red blood cells (RBCs) in an eight-week period per FDA requirements, the records stated.

Nikki Radford, center manager, was quoted in the report as saying that the company's policy was to defer donors only after a cumulative loss of greater than 200 ml in an eight-week period. The inspection turned up documentation suggesting violations in the cases of three donors.

In his Feb. 24 response to the 483, owner Gary Crandall asserted that "employees have been reinstructed that a donor must be deferred for eight weeks" in the event of RBC loss.

The 483 cited the case of a donor who lost RBCs when a plasma line pinched under the centrifuge lid, breaking the seal of the centrifuge bowl. This donor lost RBCs in a subsequent donation for unexplained reasons roughly seven weeks later, according to the EIR.

A later series of incidents of damage to centrifuge bowls triggered a second citation. The 483 stated that the company lacked "documenta-tion to support that conditions were safe for the reinfusion of red blood cells to donors following a broken seal on the centrifuge bowl."

Assistant Manager Jared Thompson could not find such information in the operator's manual or in the firm's procedures, the EIR said. Price reported in the EIR "at least five instances where records indicated that the contents of the bowl were reinfused following a break in the bowl's seal."

Bio-Medics stated in its 483 response that in-service training was conducted to update employees on appropriate procedures in the event of such equipment breaches.

Warning letter queries SOP revision

The April 14 warning letter acknowledged Bio-Medic's response, but indicated concerns over lack of procedural evaluation and revision, including termination of plasmapheresis collection, as well as documentation.

Crandall's April 22 response to the warning letter stated that in-service training covered documentation of broken seals and that employees were instructed not to re-infuse RBCs if there was any question as to seal integrity.

FDA also cited Bio-Medics for allowing an individual to donate on consecutive days. The firm's Feb. 24 letter explained that only a partial donation was made on the first day and that the total was a normal donation. However, company officials admitted that the incident "should not have occurred" and that personnel have been instructed to defer such donors in the future.

Two SOP deviations cited in the 483 were failure to retake pulses on donors exhibiting pulse irregularities and failure to repeat blood pressure tests after a "signal quality error." Bio-Medics promised close monitoring by management.

The 483 cited record-keeping problems in that plasma unit weights were "recorded onto paper towels and were later transferred to the plasma shipping record." The EIR stated that employees also were making improper corrections to plasma shipping logs and disposing the original logs.

Price noted in the EIR that SOPs required corrections to be initialed and dated and that original records be attached to the copy. In response, Bio-Medics provided in-service training, along with "written warnings...to employees who failed to follow correct procedures as stated in SOP." A similar copying-and-disposal violation was noted on the 483 regarding plasma shipping records. The company's response was that staff has been "instructed to keep all documents that needed to be recopied" according to SOPs.

The 483 cited two problems with Bio-Medics' tracking of disposition of RBCs and plasma. The EIR noted that "the firm's disposition log does not provide clear documentation that would allow all units of RBCs and plasma to be traced to final disposition." The only SOP documentation available during inspection provided no place on the form to record identifying information.

Price also cited a lack of disposal documentation, writing in the EIR that "since the firm does not record what is being disposed, it was unclear whether RBCs or plasma" was discarded.

FDA finds records inadequate

The EIR said Radford explained that the firm listed "the loss of RBCs and plasma as one entry on the disposition log." QA Director Marie Leitman told Price that information identifying unit and amount are recorded on the donor card.

However, Price noted that "donor records only contain a notation of the RBC/plasma loss and the amount. The donor record does not support the actual destruction of the discarded units."

Finally, the 483 cited the lack of records verifying final disposition of two units of RBCs.

Regarding disposition log SOPs and the disposition of the two units, the company included new procedures with its February letter and stated that "all staff have been given in-service on the new procedure and the importance of making the proper and complete documentation of disposition log."

As of deadline, Bio-Medics could not be reached for comment.

Bio-Medics, Rexburg, ID, 2/4-6/99, Doc. 108729M, $12.50 plus retrieval.