Inspections, Compliance, Enforcement, and Criminal Investigations
Mercy Medical Center 14-Jun-05
Department of Health and Human Services
Public Health Service
Kansas City District
June 14, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2005-10
A. James Tinker
CEO and President
Mercy Medical Center
701 10' Street SE
Cedar Rapids, IA 52403-1251
Dear Mr. Tinker:
During an inspection of Mercy Medical Center Blood Bank located at the address above, completed March 11, 2005, our investigator documented violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(a)(2)(B)] and Title 21, Code of Federal Regulations (21 CFR), Part 211 and Parts 600-680 as follows:
Failure to follow your standard operating procedures (SOPs) with regard to the criteria that you use to determine donor suitability [21 CFR 211.100(b), 606.100(b)(1), and 640.3(b)]. For example:
Your SOP requires you to complete health history screening, and to defer a donor from donating when certain health history information is provided . Nevertheless, you accepted numerous donors for donation even though the documentation of their health history screening was incomplete or contained potentially disqualifying information. The blood products collected from the donors were transfused, except for one case where the blood products were destroyed due to a manufacturing problem unrelated to
the health history screening. For example:
1. Your SOP provides that you will defer donors who have traveled for specified periods of time outside the United States to areas that present a risk of infection with vCJD or malaria.
One donor disclosed travel outside United States, but you accepted the donor without determining whether the travel was to areas that represent a risk of infection with vCJD or malaria.
Two donors disclosed travel to Europe, but you accepted the donors without determining whether the travel was for a period of time that would have required deferral under your SOP.
One donor disclosed travel to Mexico, but you accepted the donor without determining whether the donor traveled to an area that represents a risk of infection with malaria.
2. Your SOP requires you to obtain "yes" or "no" answers to questions regarding sex with an individual considered at high risk for infection with human immunodeficiency virus (HIV). Nevertheless, you accepted one of the donors identified in paragraph 1 who responded "N/A" to the question.
3. Your SOP requires you to obtain a response to a question concerning whether a donor has been ill during the previous two weeks. Nevertheless, you accepted one of the donors identified in paragraph 1 who did nut answer this question.
4. Your SOP requires you to obtain a response to questions related to the use of human growth hormone and whether the donor has been incarcerated. You accepted one donor who did not answer these questions.
5. Your SOP requires you to obtain a response to a question related to whether the donor is donating for the purpose of being testing for HIV. You accepted one donor who did not answer this question; nor did the donor respond to the question related to incarceration.
6. Your SOP requires you to defer a donor unless you obtained a positive response to a question concerning whether the donor understood that the HIV virus could be transmitted even though they were not sick. Nevertheless, you accepted one donor who responded "N/A" to this question, and one donor who responded "No."
7. Your SOP requires you to defer donors with a history of squamous cell carcinoma unless there has not been a recurrence for five years. You accepted one donor who disclosed a history of squamous cell carcinoma, without determining whether the carcinoma had recurred during the previous five years,
Failure to make and record a thorough investigation, including conclusions and follow-up, of any unexplained discrepancy or the failure of a unit or lot to meet specifications, and to extend the investigation to other products that may have been associated with the discrepancy or failure [21 CFR 606.100(c) and 21 CFR 211.192] in that:
Blood donor cards contain unanswered questions and information is not clarified per the Donor Phlebotomy SOP prior to donation.
Quality review procedures outlined in the Donor Phlebotomy SOP are not indicated as being done on the blood donor cards.
Failure to provide adequate space for the private and accurate examinations of individuals to determine their suitability as blood donors [21 CFR 606.40(a)(1)] in that:
During a mobile operation conducted 3/9/2005, donor health history questions and answers could be heard outside the designated private screening area set up for the examinations.
We have reviewed your letter dated April 4, 2005 in response to the Form FDA 483 issued on 3/11/2005. Your reply is inadequate in that it does not address all observations listed on the FDA 483. The documentation necessary to evaluate your corrective actions was not included, such as the donor card, Donor Suitability Guide SOP and Donor Deferral Procedures. In addition, while we note your inclusion of additional quality reviews related to donor screening and testing information, those steps alone do not represent an adequate review by the quality control unit to determine compliance with your procedures. (21 CFR 211.192). Consistent with 21 CFR 211.22(c), your quality control unit activities should have the responsibility for approving or rejecting all procedures and specifications impacting on the identity, strength, quality, and purity of the blood products you manufacture. While donor screening and donor testing operations are certainly important areas, they do not represent all manufacturing operations that can impact product identity, strength, quality, and purity.
The above identified deviations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with all requirements of the federal regulations.
You should take prompt measures to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such action includes seizure and/or injunction.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the U.S. Food and Drug Administration, Attention: Joseph G. Kramer, Compliance Officer, at the address noted in the letterhead. If you have any questions regarding any issue in this letter, please contact Mr. Kramer at (913) 752-2719.
John W. Thorsky
Kansas City District