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 centrifuge (sĕn`trəfyj), device using centrifugal force to separate two or more substances of different density, e.g., two liquids or a liquid and a solid. for only one speed.
Aultman was unable to put matters to rest before the district dished dished
2. Slanting toward one another at the bottom. Used of a pair of wheels.
Adj. 1. dished - shaped like a dish or pan
concave - curving inward 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 To adjust or bring into balance. Scanners, CRTs and similar peripherals may require periodic adjustment. Unlike digital devices, the electronic components within these analog devices may change from their original specification. See color calibration and tweak. [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 calibration /cal·i·bra·tion/ (kal?i-bra´shun) determination of the accuracy of an instrument, usually by measurement of its variation from a standard, to ascertain necessary correction factors. . Wasdahl referred to an enclosed en·close also in·close
tr.v. en·closed, en·clos·ing, en·clos·es
1. To surround on all sides; close in.
2. To fence in so as to prevent common use: enclosed the pasture. 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 according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. the SOP," in addition to alleging that Aultman could not document its quality control for red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.
Mentioned in: Bone Marrow Transplantation
red blood cells for "any months other than April and May 2001."
In his July 24 letter, Wasdahl informed FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. 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 cal·i·brate
tr.v. cal·i·brat·ed, cal·i·brat·ing, cal·i·brates
1. To check, adjust, or determine by comparison with a standard (the graduations of a quantitative measuring instrument): ." 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 OOS occupational overuse syndrome: pain caused by repeated awkward movements while at work )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 thermometer, instrument for measuring temperature. Galileo and Sanctorius devised thermometers consisting essentially of a bulb with a tubular projection, the open end of which was immersed in a liquid. . 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 cob·ble 1
1. A cobblestone.
2. Geology A rock fragment between 64 and 256 millimeters in diameter, especially one that has been naturally rounded.
3. cobbles See cob coal.
tr. 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