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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Elkhart General Hospital Blood Donor Center 5/6/09


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139




May 6, 2009


Gregory Lintjer, President
Elkhart General Hospital
600 East Boulevard
Elkhart, Indiana 46514-2499

Dear Mr. Lintjer:

The Food and Drug Administration (FDA) conducted an inspection of Elkhart General Hospital Blood Donor Center, located in Elkhart, Indiana, from December 1 through December 10, 2008. During the inspection, the investigator documented deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood components, Title 21 Code of Federal Regulations (CFR) Part 606-680. 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). These deviations include, but are not limited to, the following:

1. Failure to defer future donations of human blood and blood components from donors testing reactive by a screening test for evidence of infection due to a communicable disease agent listed in 21 CFR 610.40(a) [21 CFR 610.41(a)] and failure to restrict from use human blood and blood components collected from a donor with a previous record of a reactive screening test for evidence of infection due to a communicable disease agent [21 CFR 610.40(h)(1)]. Specifically, a unit was collected from donor MMN on 11/28/2007 (unit E68108) that tested reactive on a screening test for the antibody to the hepatitis C virus (anti-HCV). Confirmatory testing for HCV was indeterminate. According to your Standard Operating Procedure (SOP) B-53 titled "Deferral Codes," donors who test reactive for anti-HCV and have an indeterminate confirmatory test are to be permanently deferred without an opportunity for requalification. Donor MMN was not deferred on 11/28/07, as required by 21 CFR 610.41(a), and was allowed to donate on 4/29/2008 (unit E70373) and 8/30/2008 (unit E72348). The red blood cell components from both donations were transfused.

2. Failure to maintain a record from which unsuitable donors may be identified, so products from such individuals will not be distributed [21 CFR 606.160(e)]. For example, the following donors were not documented as being deferred from allogeneic donation, as required under 21 CFR 610.41(a), after testing reactive by a screening test for evidence of infection due to a communicable disease agent listed in 21 CFR 610.40(a) or reactive for a serological test for syphilis under section 610.40(i). .

a. Autologous donor BSE (unit E66844), was found to be reactive for antibodies to Human Immunodeficiency Virus, types 1 and 2 (anti-HIV-1/2).

b. Autologous donor BJC (unit E41049) was found to be reactive for Human Immunodeficiency Virus, type I antigen (HIV-1 antigen).

c. Autologous donor JL (unit E72694) was found to be reactive for the antibody to hepatitis B core antigen (anti-HBc). In addition, this donor had two previous donations which tested reactive for anti-HBc.

d. Donor SJG ((unit W071608100309) was found to be reactive for the serological test for syphilis.

3. Failure to maintain and/or follow written standard operating procedures that include all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components for transfusion and further manufacturing purposes [21 CFR 606.100(b)]. For example:

a. Your SOP B-53 titled "Deferral Codes" includes a provision to allow retesting (requalification) after six months, of those donors deferred after testing reactive for anti-HCV or anti- HIV 1/2 on one occasion and who had a negative confirmatory testing. However, the SOP fails to include a description of the requalification procedures to be used, including the testing algorithms. Additionally, under your SOP, donors who test repeat reactive for hepatitis B surface antigen (HBsAg) but who test negative on one occasion on a confirmatory test are not deferred. Under 21CFR 610.41, you must defer donors testing repeat reactive by a screening test for evidence of communicable disease agent(s) listed in 21 CFR 610.40(a). These donors may later be found to be suitable as a donor if requalified for donation by a method or process found acceptable for such purpose by FDA [21 CFR 610.41(b)].

b. Your SOPs do not include a written description of your labeling procedures for your use of ISBT labels, which must include safeguards to avoid labeling mix-ups.

c. Your SOP B-7, titled "Tracking System for Abnormal Test Results" does not include a written description of appropriate follow up if the initial attempt at donor notification fails.

The above identified deviations are not intended to provide an all-inclusive list of deficiencies at your establishment. It is your responsibility to ensure that your establishment is in compliance with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to correct these deviations promptly may result in administrative and/or regulatory, action by FDA without further notice, including, but not limited to, seizure and/or injunction.

We acknowledge receipt of your letter dated February 11, 2009, describing the corrective actions you have taken in response to FDA's inspectional observations of your operations. We have reviewed your response and found it generally adequate to address the observations. However, we are still concerned about your SOPs related to donor deferrals and lookback investigations. We note that your SOP B-20, titled "Lookback Program at EGH (HIV)," was revised in July 2006, and approved by your Medical Director on August 24, 2006, Please note that the revised final rule for Human Immunodeficiency Virus (HIV) lookback requirements was published on August 24, 2007, and became effective on February 20, 2008, see Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection ("Lookback"); Final Rule; https://webmail.fda.hhs.gov/exchweb/bin/redir.asp?URL=http://www.fda.gov/cber/rules/hcvlook.pdf. You should ensure that your current SOP is updated to include all the lookback requirements under 21 CFR 610.46.

We also note that your SOP B-54 titled "Quarantine and Disposition of Units from Prior Collections," includes recommended "lookback" procedures for units collected from donors who subsequently test repeat reactive on a screening test for Hepatitis B surface antigen (HBsAg), the antibody to Hepatitis B core antigen (anti-1413c), Human T-Lymphotropic Virus, types I and 11(HTLV-I/II), and HIV-1 or HCV by the Nucleic Acid Test (NAT). Please note that the Hepatitis C Virus (HCV) Lookback final rule was published on August 24, 2007 and became effective on February 20, 2008. We have listed and linked the final rule in the preceding paragraph. You should ensure that you update your SOPs to reflect the new regulation for required HCV lookback under 21 CFR 610.47. Additionally, if your establishment did not previously perform recommended lookback investigations for units collected from donors who subsequently test repeat reactive on a screening test for anti-HCV, you are required to perform a one-time retrospective "lookback" based on a review of historical testing records for anti-HCV, as required under 21 CFR 610.48. Please note that this review was required to be completed by February 19, 2009. For further recommendations for complying with 21 CFR 610.47 and 21 CFR 610.48, refer to FDA Guidance for Industry: "Lookback" for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV (August 2007) [http://www.fda.gov/cber/guidelines.htm].

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, including any documentation of the corrective actions you have taken. If all corrective actions 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 response to Sandra Williams, Compliance Officer, at the above address. Feel free to call Ms. Williams at 313-393-8118 should you have any questions.



Joann M. Givens
District Director
Detroit District Office

Cc: via certified mail: Gregory S. Losasso
Vice President, Operations