Inspections, Compliance, Enforcement, and Criminal Investigations
Sibley Memorial Hospital 12/15/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
December 15, 2009
RETURN RECEIPT REQUESTED
Mr. Robert L. Sloan
President & CEO
Sibley Memorial Hospital
5255 Loughboro Road, NW
Washington. D.C. 20016
Dear Mr. Sloan:
During an inspection of Sibley Memorial Hospital, located at 5255 NW Loughboro Road, Washington, D.C. 20016, conducted by the Food and Drug Administration (FDA) between September 14 and September 18, 2009, our investigator documented numerous significant violations of the Current Good Manufacturing Practice (CGMP) regulations for blood and blood products, Title 21, Code of Federal Regulations (CFR), Parts 600-680. These violations cause your blood and blood products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Food Drug, and Cosmetic Act (FD&C Act), 21 USC 351(a)(2)(B). (You may find the Act and FDA regulations through links in FDA's home page at www.fda.gov.) The violations include, but are not limited to, the following:
1. Failure to establish, maintain, and follow an appropriate system for notifying transfusion recipients of subsequent positive supplemental test results, as required by 21 CFR 610.47(b)(3). Specifically, your facility was notified on January 13, 2009, by the supplier of unit (b)(6) that the donor of that unit subsequently had a reactive screening test result for hepatitis C virus (HCV). The unit had been transfused at your facility on February 25, 1998. At the time of the FDA inspection, your facility had not contacted the supplier to obtain the donor's supplemental test result. After the investigator discovered this failure, you contacted the supplier and discovered that the donor's supplemental test result for HCV was positive. [FDA 483 observation 6]
2. Failure to maintain concurrently with the performance of each step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced, as required by 21 CFR 606.160. Such records must identify the person performing the work, the dates of the various entries, show test results as well as the interpretation of the results, show the expiration date assigned to specific products, and be as detailed as necessary to provide a complete history of the work performed. Specifically, the "Request For Irradiation Services" and the electronic records related to eight blood components shipped to the irradiation contractor on February 28, June 19, July 22, and August 19, 2009 did not include one or more of the following: the date and time of the shipment to and the return from the contractor, inspection of the RadSure label, and conversion to an irradiated blood component. The blood components are (b)(6) and (b)(6) [FDA 483 observation 1]
3. Failure to review all records pertinent to a lot or unit maintained pursuant to these regulations before the release or distribution of a lot or unit of final product, and failure to complete and record a thorough investigation, including the conclusions and follow-up, of any unexplained discrepancies or failure of a lot or units to meet any of its specifications, as required by 21 CFR 606.100(c). Specifically,
a. The FDA investigator reviewed seven irradiation logs, "Requests For Irradiation Services," documenting irradiation of thirteen blood components in 2009, and found significant
omissions. Additionally, your electronic records related to several of those blood components were incomplete and/or inconsistent with the logs. At the time of the inspection, the logs and electronic records had not been reviewed by staff at your facility. The irradiated blood components had all been released and transfused. [FDA 483 observation 8] For example:
i. On February 28, 2009, Red Blood Cell was shipped to your irradiation contractor, irradiated, and returned to your facility. The electronic record related to that blood component does not include documentation of the shipment and of the conversion of that component to an irradiated component. The blood component was transfused on February 28, 2009.
ii. On July 22,2009, Red Blood Cells, (b)(6) and (b)(6) were shipped to your irradiation contractor irradiated, and returned to your facility. On August 19, 2009, Red Blood Cells, (b)(6) and (b)(6) were also shipped to the irradiation contractor, irradiated, and returned to your facility. Your electronic records related to those blood components do not include documentation of the shipment and the conversion to irradiated blood components. Each of the components was transfused on July 23, 2009 and July 22, 2009, July 23, 2009, and July 22, 2009 respectively.
b. The FDA investigator reviewed records related to five occurrences between May and August 2009 of failure to perform antigen typing on blood or blood components, in accordance with your facility's procedures. Other than completing the antigen typing, there is no record of an investigation, conclusion or follow-up for those five occurrences. For example, blood component (b)(6) was transfused on June 6, 2009; however, the required antigen typing was not performed until June 8, 2009. Your variance record does not include documentation of an investigation to determine why the testing was not performed as required and whether a corrective action was taken to prevent recurrence. [FDA 483 observation 2]
4. Failure to maintain 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, as required by 21 CFR 606.100(b). [FDA 483 observation 3] For example:
a. Your facility has no written procedures describing the process for ensuring temperature control of blood and blood components shipped to and returned from your irradiation contractor. Specifically, temperatures are not checked for returned blood components; there is no assurance of temperature control while components are at the contractor; and there are no assurances that the coolers used for transport are validated for time and temperature control.
b. Your facility has no written procedure that requires documentation of the identity of the individuals who remove blood components from controlled storage and pack them for shipment to your irradiation contractor. Thirteen blood components shipped on February 10, February 28, June 16, June 19, July 22, August 5, and August 19, 2009 have no record of who performed these steps.
5. Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer, as required by 21 CFR 606.65(e). Specifically, on September 14, 2009, the FDA investigator observed blood bags stored in open pouches with no record of when they were opened which is necessary to ensure that they are used within the time frames established in the manufacturer's instructions for use. For example, five foil pouches were observed containing various numbers of blood bags that had been removed from the foil pouches and the inner plastic layer and pre-labeled with a green autologous sticker. The investigator was informed that the pouches were opened on September 11, 2009, but you have no record showing the date on which the five pouches were opened and the blood bags were removed from the inner plastic covering for pre-labeling, and who performed these steps. Additionally, donation records for September 14, 2009, indicate that two autologous units of blood were collected using blood bags from the manufacturer's Lot # FM09B27034. [FDA 483 observation 4]
6. Failure to establish, maintain and follow a procedure to receive information on all deviations, complaints, and adverse events from a contractor who performs, manufacturing, holding, or distribution steps while blood products are under your control, as required by 21 CFR 606.171(a). Specifically, you have no such procedure to obtain information pertaining to deviations that may occur during irradiation of blood and blood components that you have shipped to your contract irradiator. [FDA 483 observation 9]
7. Failure to report to FDA events and information relevant to events associated with the manufacturing, to include testing, processing, packing, labeling, or storage, or with the holding or distribution, of both licensed or unlicensed blood or blood components, as required by 21 CFR 606.171(b). The FDA investigator discovered that two reportable events were not reported to FDA. [FDA 483 observation 7] For example:
a. On January 23, 2009, Red Blood Cells (b)(6) and (b)(6) were transfused to a patient with a negative antibody screening result. On January 24, 2009, you discovered that the patient's archived history was not checked and the two blood components were not antigen typed or Coombs cross-matched prior to transfusion.
b. On June 6, 2009, a patient was transfused with units and (b)(6) and (b)(6). On June 8, 2009, you discovered that the required antigen typing had not been completed prior to release of the blood components for transfusion.
The deviations identified above are not intended to be 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 deviations. 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.
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 Nancy Rose, Compliance Officer, U.S. Food and Drug Administration, Baltimore District, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, you may contact Ms. Rose at (410) 779-5415.