Inspections, Compliance, Enforcement, and Criminal Investigations
Washington Hospital Center 04-Oct-07
Department of Health and Human Services
Public Health Service
Baltimore District Office
October 4, 2007
Return Receipt Requested
Mr. James Caldas, President
Washington Hospital Center
110 Irving Street, NW
Washington, D.C. 20010-2976
Dear Mr. Caldas:
During a Food and Drug Administration (FDA) inspection of the Washington Hospital Center's blood bank located at 110 Irving Street, NW, Washington, D.C. 20010, between July 23 and August 16, 2007, our investigator documented numerous 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). These deviations include, but are not limited to, the following:
1. Failure to maintain records concurrently with the performance of each significant 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. [21 CFR §§ 606.160(a)(1), 606.160(b)(2)(i), 606.160(b)(2)(ii), 606.160(b)(5)(iv)] For example,
a. The blood bank lacks blood processing records, including results and interpretations of all tests and retests, for donors who were reactive by screening tests for evidence of infection due to a communicable disease agent. For example,
i. A unit of whole blood collected from donor [redacted] on December 20, 1990, was reactive to screening tests for hepatitis C virus (HCV). During the period August 23, 1991 through August 10, 2005, the blood bank collected 36 units of whole blood from that donor, and 90 blood components manufactured from those units were distributed and transfused. There are no test records documenting re-qualification of the donor using a method or process found acceptable by FDA until November 18, 2005. (483 item 1A)
ii. A unit of whole blood collected from donor [redacted] on December 14, 1990, was reactive to screening tests for HCV. During the period June 13, 1991 through April 16, 2003, the blood bank collected 15 units of whole blood from that donor, and 34 blood components manufactured from those units were distributed and transfused. There are no test records documenting re-qualification of the donor using a method or process found acceptable by FDA. (483 item 1B)
b. The blood bank lacks quality control records to document the capacity of a shipping container to maintain proper temperatures while in transit. Specifically, the FDA investigator observed that donor blood specimens for nucleic amplification testing had been transported from a mobile collection site to the blood bank laboratory in an unqualified cooler with no thermometer present to ensure that the internal temperature was 2-8C°, which is the range specified by SOP [redacted] effective April 30, 2007. (483 item 5)
c. SOP [redacted] effective April 30, 2007, requires that after being separated from plasma, platelets be allowed to rest on a mat on a counter for one hour prior to being placed in the platelet incubator. The blood bank does not monitor the time interval or maintain a record to ensure that the platelets have rested for one hour. (483 item 4A)
2. Failure to perform a thorough investigation of each reported adverse reaction regarding each unit of blood or blood product arising as a result of blood transfusion. [21 CFR § 606.170(a)] Specifically, a suspected transfusion-related lung injury (TRALI) reaction was reported to the blood bank on May 25, 2007. The recipient had been transfused with 14 blood components, seven of which were provided to the blood bank by a supplier. The FDA investigator observed that the blood bank erroneously notified the supplier of only six of the seven involved components, resulting in no TRALI reaction investigation for the seventh component. On August 2, 2007, after the investigator's observation, the blood bank notified the supplier of the additional component and the investigation was completed by the supplier (483 item 3B).
3. Failure to maintain and/or follow written standard operating procedures (SOPs) 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. The blood bank did not follow its SOP [redacted] implemented in November, 2006, which requires notification of suppliers "as soon as possible." A suspected TRALI-related reaction was reported to the blood bank on May 29, 2007. The reaction occurred after transfusion of two blood components received from a supplier; however the blood bank took no action to notify the supplier until June 20, 2007, thereby delaying the supplier's investigation and follow-up for 22 days after the reaction. (483 item 3A)
b. The blood bank did not follow its SOP [redacted] implemented November 2004, which provides instructions for investigating and documenting post-donation information. The SOP requires completion of a Post Donation/Third Party Information Report (PDR) upon receipt of such information. The PDR must include information relevant to the donor's deferral status and to the appropriate disposition of affected blood or blood components. The quality assurance unit (QA) is required to review PDRs. The FDA investigator's review of approximately 50 PDRs revealed the following:
i. QA did not review five PDRs pertaining to information received on January 16, 2007, (two donors), March 8, 2007, March 30, 2007, and April 23, 2007, to ensure appropriate disposition of affected blood or blood components until June 13, 2007 (483 item 6A);
ii. QA did not review two PDRs pertaining to information received on May 23, 2007 and June 8, 2007, to ensure appropriate disposition of affected blood and blood components (483 item 6B);
iii. A PDR pertaining to information received on June 4, 2007, lacks documentation regarding disposition of the affected blood or blood components and was not reviewed by QA. (483 item 6C)
c. The current and previous versions of SOP [redacted] effective dates April 30, 2007, and October 2004, are inadequate because they do not define and provide instructions for use of the terms "temporary deferral" and serological deferral." These terms represent deferral categories used by the blood bank to monitor the status of donors for communicable diseases and other deferral reasons. (483 item 2)
4. Failure to perform a thorough investigation and make a record of the conclusions and follow-up of any unexplained discrepancy. [21 CFR § 606.100(c)] Specifically, the FDA investigator's review of Process/Product Deviation Reports (PPDR) for the period July 2006 through July" 2007 found that six PPDRs required follow-up actions; however, there are no records of the follow-up actions. For example, the following PPDRs each require the follow-up action, "Discuss with Employee"; however, there is no record of the discussions having occurred:
a. PPDR [redacted] which involves an employee's failure to document the distribution of six units of platelets on February 8, 2007; (483 item 7A)
b. PPDR [redacted] which involves an employee who used an incorrect donor name to request a blood test on February 4, 2007; (483 item 7D)
c. PPDR [redacted] which involves an employee who misinterpreted an ABO/Rh test result and recorded an incorrect result. (483 item 7E)
Our office is in receipt of your letter dated September 14, 2007, describing the steps you have taken and intend to take to correct the deviations noted on the FDA 483-Inspectional Observations issued at the close of the inspection on August 16, 2007. We have reviewed your response and find the corrective actions, in general, to be isolated to the observations of the FDA 483. This response does not address the underlying causes of the deviations. Your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.
The above identified deviations 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 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.
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 L. Rose, Compliance Officer, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, contact Ms. Rose at (410) 779-5415.
Kirk D. Sooter
Acting Director, Baltimore District
cc: Janis M. Orlowski, M.D.
Senior Vice President for Medical Affairs
And Chief Medical Officer
Washington Hospital Center
110 Irving Street, NW
Washington, D.C. 20010-2976