Inspections, Compliance, Enforcement, and Criminal Investigations
Memorial Medical Center 24-Oct-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
October 24, 2006
RETURN RECEIPT REQUESTED
Refer to MIN 07 - 03
Daniel J. Hymans
Memorial Medical Center
1615 Maple Lane
Ashland, WI 54806
Dear Mr. Hymans:
During a Food and Drug Administration (FDA) inspection of your hospital blood bank located at 1615 Maple Lane, Ashland, Wisconsin on August 21 - 23, 2006, our investigator documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood components, Title 21, Code of Federal Regulations (CFR), Part 606. These deviations cause your blood products to be adulterated within the meaning of section 501(a) (2) (B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C 351(a)(2)(B)]. The deviations include, but are not limited to, the following:
1. Personnel responsible for the compatibility testing of blood and blood components do not have adequate training and experience to ensure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess, as required by 21 CFR 606.20(b). Specifically, two technicians were involved in compatibility testing where procedures were not followed and the results were not accurate.
a. On May 4, 2006, a technician repeatedly did not follow all steps identified in written procedures for pre and post antibody screening on a patient. In addition, this technician yielded negative results for the "Pre-Warm Antibody Screen" which was later confirmed positive.
b. A second technician who assisted in the post transfusion work-up agreed with the results.
c. Training documentation does not always include supporting documentation (such as written tests or signed statements) that indicates the trainees have an understanding of all procedures required for the position. The current method used to document training is a check-list of functions that are checked off as observed and discussed.
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all blood products issued by your transfusion facility are in compliance with the Act and the cGMP regulations. Your failure to correct these deviations may result in regulatory action being taken by FDA without further notice. Possible action may include seizure or injunction.
We request that you notify this office in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct these violations, including examples of any documentation showing that corrections have been achieved. If you cannot complete all the corrections before you respond, please explain the reason for your delay and the date by which each item will be corrected and documented.
Please send your reply to the Food and Drug Administration, Attention: Jane Nelson, Compliance Officer, at the address in the letterhead. If you have any questions regarding any issue in this letter, please contact Ms. Nelson at (612) 758-7119.
W. Charles Becoat