Equipment QC, calibration, backbones for blood bank citations.

Aultman Health Foundation of Canton, OH, netted a 13-item 483 after Cincinnati district investigator Nancy Neige's June 2001 inspection, including a finding that the unlicensed blood bank performed quality control on a two-speed centrifuge for only one speed.

Aultman was unable to put matters to rest before the district dished out a July 6, 2001, warning letter (Doc. 10636W) that complained Aultman "waited almost one full year" before responding to a 483 received in 2000.

Aultman Medical Director Daniel Wasdahl wrote July 24 that the director of the blood center at the time of the audit, who has since left the establishment, had inked up a reply to the earlier 483, but never got the response in the mail. The warning letter noted Aultman's staff put the document in Neige's hands during the latest inspection.

Regarding centrifuge quality control, the 483 noted: "Quality control is not always performed" using both speeds in two preparation centrifuges. Neige wrote that "only one speed was documented over 100 times" between October 2000 and May 2001. The warning letter stated only that Aultman employed the centrifuges at both speeds but that staff "only calibrate[d] the machine to one speed."

Wasdahl added that management had reviewed the relevant SOPs with staff, implying that the procedure called for dual-speed calibration. Wasdahl referred to an enclosed copy of the log for June 2001, showing dual-speed calibration.

The 483 commenced by citing Aultman for seven missing temperature charts for five coolers, one of which was for a surgery department and one for an emergency department. The warning letter commented that "your records also do not indicate that the charts are always changed according to the SOP," in addition to alleging that Aultman could not document its quality control for red blood cells for "any months other than April and May 2001."

In his July 24 letter, Wasdahl informed FDA he had reassigned maintenance of the temperature logs to a "tech specialist" whom he said would go around "on a weekly basis to collect the temperature logs." He noted that previously, this junction had been handled by the nursing staff and indicated an attachment for the amended SOP.

The 483 stated that there were 15 incidents in the first five months of 2001 in which hematastat QC was "not always in range," and for failure to investigate the excursions. Neige wrote that the hematastats making up this finding were employed in mobile units and the fixed donor room.

The warning letter addressed the hematastat problem only as one in which the equipment was not "properly calibrated." In reply, Wasdahl told FDA he had put together a schedule for QC and had assigned a member of the blood bank staff to "be accountable on a monthly basis for QC for all equip-ment." He also noted that Aultman had gone over proced-ures to be employed in the event of out-of-specification (OOS)outcomes and related documentation requirements.

FDA snared the establishment for lack of procedures for "calibration or QC" of a Donormatic scale and a hematastat. District director Henry Fielden listed these separately in the warning letter, stating that Aultman had simply failed to calibrate the hematastat and an oral thermometer. The hangup with the Donormatic was written up as lack of a procedure for calibration, which Fielden grouped with lack of a procedure for quality control checks on centrifuge speeds.

Wasdahl wrote back that the Foundation had cobbled together a procedure to address this finding and that the staff was trained on this daily function.

Aultman's lab director, Sue Battig, said in an interview that Aultman had not heard from FDA regarding additional post-inspection correspondence and expected the agency to maintain its annual inspection schedule with the blood bank in 2002.

Battig faxed the establishment's Aug. 23 letter to FDA regarding three warning letter citations the responses for which the agency found lacking. These included sign-in sheets for in-service meetings, the use of thermometers displaying temperatures in half-degree increments and daily quality control for a microhematocrit centrifuge.

Aultman Health Foundation, Canton, OH, 6/6-8, 11, 12, & 15/01, Doc. 109138M, $5.50 plus retrieval.

RELATED ARTICLE: The Checklist - Aultman Health Foundation

* quality control

* lack of SOPs