Blood bank inspection hits records, deferral practices.

Community Blood Council of New Jersey, Ewing Township, NJ, New Jersey District.

Correcting all the deficiencies found at a previous inspection did not protect a licensed blood bank, the Community Blood Council of New Jersey, from receiving another 483 following an inspection last May, according to the recently released EIR. The facility previously operated as the Community Blood Council of Mercer County.

The last inspection, in June 1995, slapped the blood bank for problems with SOPs for platelet pheresis, supervisory review, and quality control of its CuSO4 solutions.

The latest inspection, conducted by Investigator Ann Marie Schofield at a mobile blood drive, targeted calculation of annual blood loss for platelet pheresis donors, donor deferral, platelet QC, handling of fresh frozen plasma, and comparison of temperature readings and the temperature recording chart.

The EIR highlighted a disagreement between Schofield and the blood bank's compliance officer, Sharon Rosen, regarding interpretations of FDA's requirements for thermometer readings.

When Schofield asked what the blood bank's acceptable values were for discrepancies between temperature recording charts and thermometers, Rosen answered that a difference of 2oC would necessitate both an investigation and corrective action, the report stated. However, Schofield noted several cases where a greater discrepancy was recorded.

According to Rosen, if corrective action were taken it would have been noted on the worksheets in question, the EIR stated. Rosen added that the temperature readings in question were appropriate for those units and asserted that FDA only required daily comparison of the readings, not corrective action.

Schofield countered that the SOP only required recording the values and "with no established acceptable values, there is no assurance that [comparison] is being done consistently," according to the EIR. The inconsistencies in the readings could indicate a problem with temperature recording charts and might result in an alarm not going off when it should, she added.

The EIR said that during the exit interview Chief Executive Officer Patrick Deschene expressed concern about the variability in recorded temperatures, promising that acceptable values would be established and the procedure updated.

Schofield also found two donor deferral violations. One involved failure to look up all names of donors who have used more than one name. According to the EIR, management had no response to this observation at the exit interview.

The other deferral issue involved handling hepatitis B core virus (HBc) reactive donors. Schofield found that this was one individual's responsibility, but there was no written procedure to use in that person's absence. The EIR said Rosen drafted an SOP during the course of the inspection.

When Schofield found that fresh frozen plasma did not go into the freezer within the required eight hours, Rosen provided an amended component preparation worksheet with the specified time limit.

The EIR also noted that the draw times for random donor platelet units exceeded the firm's eight-minute maximum. At the exit interview, Rosen promised to modify the appropriate SOP and worksheet, the report said.

Schofield also cited the blood bank for not recording the date of platelet QC testing, a deficiency that Rosen promised to amend, according to the inspection report.

No arrows and ditto marks: FDA

Two more items never crossed from the EIR to the 483. In one case, Schofield warned against using arrows and ditto marks on records to show completion of labeling, noting that some units had escaped labeling due to this practice.

Schofield also discussed a possible shortcoming in the calculation of annual blood loss for platelet pheresis donors. The EIR stated that she discussed FDA's requirements in this area with staff at the Center for Biologics, who told her that the blood bank should be including blood loss from samples collected, not just that from the automated pheresis system itself.

Schofield relayed this information to the blood bank after the inspection, the EIR said, and Quality Control Manager Charmaine Weldon promised to amend the procedure.

Management could not be reached for a comment or update regarding the inspection.

Community Blood Council of New Jersey, Trenton, NJ, 5/6-9,13-15/96, Doc. 107792M, $5.50 plus handling.