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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bothwell Regional Health Center 4/16/07

Department of Health and Human Service's Eagle LogoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

Kansas City District
Southwest Region
11630 West 80 Street
Lenexa, Kansas 66214-3340

Telephone: (913)752-2100


April 16, 2007


Ref. KAN 2007-06

Dennis Johnson, M.D.
Laboratory Medical Director
Bothwell Regional Health Center
601 East 14th Street
Sedalia, MO 65301

Dear Dr. Johnson:

During an inspection of your blood bank, located at 601 East 14th Street, Sedalia, MO, between January 29, 2007 through February 15, 2007, an FDA investigator from this office documented numerous deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations (CFR), Part 606. Further, several deviations from the Additional Standards for Human Blood and Blood Products, Title 21 CFR Part 640 were also documented. These deviations cause your products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 351(a)(2)(B)]. The deviations included the following:

  • Failure to perform a thorough investigation of each reported adverse reaction. [21 CFR 606.170(a)]

    • A thorough investigation of blood product transfusion reaction, as per the Nursing Standard Operating Procedure (SOP) "Blood Transfusion and Adverse Reaction Management" and the Blood Bank SOP "Transfusion Reaction Workup", was not always performed. A review of Transfusion Records for the months of October, November, and December 2006 revealed approximately 13 separate transfusion events where recipient symptoms associated with transfusion reaction, defined in the above SOPs, were documented; however, no further investigation was performed to ensure blood product compatibility. For example:

  • On 12/9/06, recipient [redacted] experienced a 2.2 °C temperature increase during the transfusion of unit [redacted] The Transfusion Record also documents a review (undated) by CL; however no subsequent action was documented.

  • On 11/1/06, recipient [redacted] experienced a 3.5 °C temperature increase during the transfusion of unit [redacted]. The Transfusion Record also documents a review (undated) by CL; however no subsequent action was documented.

  • Failure to review all records pertinent to a lot or unit before the release or distribution of a lot or unit of final product. [21 CFR 606.100(c)]

    • Specifically, the documentation for the collection of Autologous Whole Blood units does not always receive a documented review prior to unit release. For example:

  • Donor/recipient [redacted] Autologous Whole Blood donations on 12/29/06 and 1/2/07 have no information in the "REVIWED (sic) BY:" boxes on the "Autologous Donation and Informed Consent" forms

  • Donor/recipient [redacted] Autologous Whole Blood donations on 11/28/06 and 12/4/06 have no information in the "REVIWED (sic) BY:" boxes on the "Autologous Donation and Informed Consent" forms

  • Failure to perform a thorough investigation and make a record of the conclusions and follow-up of an unexplained discrepancy or a failure of a lot or unit to meet any of its specifications. [21 CFR 606.100(c)]

    • Specifically, the 1/2/07 Autologous Whole Blood donation of donor/recipient [redacted] resulted in a collection volume of 250-255 mls. Firm SOP, "Autologous BloodCollections", section 6.13.4 states "Under-collected units less than 300 grams may be suitable with Medical Director/Pathologist approval. " No documentation of any such distinct approval or justification for use was observed, nor was any documentation of anti-coagulant adjustment for the unitobserved. The unit was subsequently transfused.

  • Failure to request from CBER (Center for Biologics Evaluation and Research) and obtain approval for exceptions or alternatives to requirements in Subchapter F of Chapter I of 21 CFR, Part 600-680 [21 CFR 640.120(a)]

    • According to the Blood Bank Communication Logbook, approximately 65 Red Blood Cell units experienced multiple temperature excursions between 11/30/05 and 12/4/05. One of the temperature excursions, 11/30/05 - 12/1/05, reached a temperature of 6.5 °C for approximately 11 hours, exceeding the product label requirement of a storage temperature within the range 1-6°C. The regulations allow for operating contrary to applicable regulations, as long as a variance for the discrepant practice has been submitted to, and approved by, CBER. However, the 65 temperature-abused units were subsequently accepted for use by the Medical Director and Laboratory Director without variance request and/or approval by the Food and Drug Administration, and in contradiction to the firm's SOP "Component Storage", which also requires a storage range of 1-6°C for Whole Blood and Red Blood Cells. Of these 65 temperature-abused units, approximately 57 were subsequently transfused by Bothwell Regional Health Center.

  • Failure to determine the suitability of a donor as a source of blood by a qualified physician or by a trained person under his supervision on the day of collection. [21CFR 640.3(a)]

    • Specifically, autologous donor/recipients donating a series of Whole Blood Units only receive a medical history on the initial day of donation. The donor does not receive a medical history on the date of subsequently donated units.

  • Failure of records to identify the person performing the work, include dates of the various entries, and be as detailed as necessary so as to provide a complete history of the work performed. [21 CFR 606.160(a)(1)]

    • Specifically, the "Autologous Donation and Informed Consent" for donor [redacted] does not document the date of the performance of the medical history questionnaire, pre and post-donation vitals, and review.

The deviations identified above 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 correct these deviations promptly may result in administrative and/or regulatory action without further notice. Such action may include seizure and/or injunction.

Our office is in receipt of your letter dated February 23, 2007 addressing the initial steps you are taking to correct the deviations noted on the FDA 483 Inspectional Observations issued at the close of the inspection on February 15, 2007 . We have reviewed this response and find the corrective actions, in general, to be isolated to the specifics of the FDA 483. This response does not address the underlying causes of the violations which may include ineffective oversight of personnel and record review. To date, your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.

Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of any additional steps you have taken to correct the noted deviations 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. Your reply should be sent to Amy E. Devine, Acting Compliance Officer, at the above address.



John W. Thorsky
District Director
Kansas City District

cc: Julia M. Eckstein, Director
Missouri State Dept. of Health and Senior Services
912 Wildwood
P.O. Box 570
Jefferson City, MO 65102-0570