Blood bank's reshuffling of paperwork hopes to streamline operation. (Blood & Biologics).

Mississippi Blood Services (MBS), Jackson, MS, was hit with a failure to perform quality control on and calibration of the refractometer used to determine the refractive index of red blood cells in the processing of deglycerolized red blood cells, according to findings from a March 25-April 2, 8 & 12 inspection.

Investigator Eddie Rigsby of the New Orleans District kicked off an eight-item 483 with deficiencies observed in the facility's handling of deglycerolized red blood cells.

This only counted as one four-count item in the 483. But in the July 2, four-page warning letter (Doc. 11802W), deglycerolized red blood cells deficiencies accounted for nine citations.

According to the 483, Rigsby noted MBS had no documentation that QC was performed on the refractometer used in processing units of deglycerolized red blood cells, although the units were listed as sold in the firm's computer system. The EIR was not available before deadline.

Rigsby went on to note the final disposition of units recalled because of failure to perform QC on the refractometer was not documented, nor was the firm's QA unit notified. Also, the preparation of these units was not documented in the log that keeps track of lot numbers and expiration dates.

While MBS VP and Regulatory Affairs & Compliance Officer Lisa Wagner responded to the 483 via a June 7 correspondence, it did little to take the steam out of the resulting warning letter.

The letter noted the blood bank did not have entries in its "Refractometer Quality Control Log" for Feb. 15 and March 20, 2001, or any entries for the month of December that year. The letter cited that units of blood were distributed during these times.

A July 27 response from Wagner noted in a root cause analysis that the establishment was using two different forms and filing them separately. The forms were entitled "Refractometer QC Log" and "Deglycerolized Red Blood Cell Log."

Wagner wrote: "The potential for misplaced/lost QC documentation would be eliminated if all steps associated with the deglycerofzation process were recorded on one form."

In addition to several corrective actions, MBS decided to modify the "Deglycerolized Red Blood Cell Log" to include a column for recording refractometer QC results.

The 483 also addressed deficiencies concerning MBS' handling of apheresis platelets in that the blood bank failed to establish specifications to assure that apheresis platelets were safe and failed to conduct and document an investigation of unacceptable quality control tests on units.

Wagner stated there was no corrective action taken regarding this citation, adding that "the document referenced by the investigator ... is not a facility procedure."

Wagner cited the SOPS that the establishment followed adding that corrective action was not required "for the implicated units since they were processed in compliance with current SOPS."

Finally, the 483 noted the blood bank had several deficiencies concerning its training efforts. Among these included trainees having different checklists documenting areas covered, no evidence of a written test, and the lack of an annual performance test.

To this, Wagner responded that the facility lacked a standard format "for defining, conducting and tracking employee initial and annual competency requirements."

As an intermediate corrective action, the exec included an annual competency evaluation form to the agency and attached updated personnel training and competence assessment quality procedures.

In a telephone interview, Wagner said MBS training program was "going well" and that intermediate goals have been met. Only one additional full-time employee needed to be hired for the effort.

For the long run, Wagner told FDA that designated staff would act as department trainers and that the director of corporate training would report directly to her. The director of corporate training would work with department managers to develop competency guides for each job title, Wagner told the agency. Additionally, all employee training and competency data would be entered into a computer database, she noted.

She added in the interview that this long-term goal should be achieved by June 2003.

Mississippi Blood Services, Jackson, MS, 3/25-4/2, 8 & 12/02, Doc. 109319M, $13.50 plus retrieval.

[check] The Checklist--MBS

[check] QC documentation

[check] product specifications

[check] employee training issues