Inspections, Compliance, Enforcement, and Criminal Investigations
Community Blood Center of Greater Kansas City 09-Mar-06
Department of Health and Human Services
Public Health Service
Kansas City District
March 9, 2006
RETURN RECEIPT REQUESTED
Ref. KAN 2006-14
Jay E. Menitove, M.D.
Executive, and Medical Director
Community Blood Center of Greater Kansas City
4040 Main Street
Kansas City, MO 64111
Dear Dr. Menitove:
During an inspection of your blood bank between November 18, 2005 through January 23, 2006, FDA investigators from this office documented numerous deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations (CFR), Part 606. 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:
Written standard operating procedures including all steps to be followed in the collection, processing, and distribution of blood and blood components for homologous transfusion and autologous transfusion are not always maintained and followed. [21 CFR 606.100(b)] For example:
Procedures designed to ensure blood products are free of microbial contamination were not followed in that the audible alarm for the BacT/Alert Microbial Detection System was not activated to alert personnel of a positive test result. The BacT/Alert system is also equipped with a color-coded monitor alert system for detected positive samples which was not utilized. On 12/21/2005, a microbial positive unit was released and shipped to an area hospital where it was transfused and found to have been a contributing factor in a transfusion-related fatality.
Your firm does not follow a procedure protecting the donor from the return of hemolyzed Red Blood Cells during the plasmapheresis procedure or defining the appropriate actions to take when hemolysis is suspected or observed in a pheresis set.
Equipment maintenance and repair records for an automated ABO/Rh blood typing machine (PK7200) and dielectric tube sealers are not being maintained as required by your written standard operating procedures to routinely include the reason for the repair.
Failure to use an approved screening test to test blood and blood components for Hepatitis B Surface Antigen (HbsAg) according to the manufacturer's instructions in that a test run was improperly invalidated. [21 CFR 610.40(b), 610.41, and 606.100(b)(20)]
Failure to perform a thorough investigation and make a record of the conclusions and follow- up of an unexplained discrepancy . [21 CFR 606.100(c)] On December 13, 2005, during the course of routine testing using the automated ABO/Rh blood typing machine (PK7200), an error message code ".GH" was displayed at least twice . Staff members performing this testing took no action following the error code and could not explain its significance. The unknown code was not further investigated to determine the significance until it was brought to the attention of management by FDA.
Failure to assure that personnel have the necessary training in and a thorough understanding of the operations which they perform. [21 CFR 606.20] An example of inadequate training which can affect donor health is that employees performing apheresis collections have no been formally trained in the risks associated with the return of hemolyzed red blood cells to a donor.
The standard operating procedure fails to include, a written description of the donor deferral process for all known, potential donor reactions. There are at least three cases where the donor experienced reactions' such as having anaphylactic symptoms, pallor, vomiting, lightheadedness, loss of consciousness, etc., yet no written deferral was noted in the donor records because these reactions were not categorized as "severe" by your firm. 21 CFR 606.100(b)(20)]
Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained. [21 CFR 606.170(a)] There are at least three instances where the donation record indicates the donor fainted, but there is no documentation to support the. donor's vital signs remained within acceptable ranges and/or their symptoms were successfully resolved.
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 regulatory action without further notice and/or administrative action. Such action includes license suspension and/or revocation, seizure and/or injunction.
Our office is in receipt of your letter dated February 13, 2006 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 January 23, 2006. 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. During your visit to our office on February 17, 2006, you and your management team indicated root cause analysis was being considered but was not formalized or complete. 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 15 working days of receipt of this letter, of any additional steps you have taken to correct the noted deviations and to prevent their reccurence. 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 Nadine Nanko Johnson, Compliance Officer, at the above address.
John VV. Thorsky
Kansas City District