Inspections, Compliance, Enforcement, and Criminal Investigations
Uintah Basin Medical Center 19-Jun-08
Department of Health and Human Services
Public Health Service
Denver District Office
June 19, 2008
RETURN RECEIPT REQUESTED
Mr. Bradley D. LeBaron
Uintah Basin Medical Center
250 West 300 North
Roosevelt, Utah 84066
Ref. # - DEN-08-16
Dear Mr. LeBaron:
During an inspection of your blood bank, located at 250 West 300 North, Roosevelt, Utah, from January 30, 2008 through February 1, 2008, an investigator from the United States Food and Drug Administration (FDA) documented deviations from the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations (CFR), Part 606 (21 CFR 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 (the Act) (21 U.S.C. 351(a)(2)(B)). The deviations include the following:
1. 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 (21 CFR 606.100(b)).
a. Your SOP titled "Retrieving Blood" states that [redacted]. On December 8, 2007, your laboratory technologist issued a unit of blood for transfusion to patient [redacted] without verifying the patient unit information required by the SOP. The Transfusion Service Record was signed and dated by the lab technologist and a nurse after confirming that only the unit number and expiration date on the blood bag matched the accompanying paperwork. The patient name and arm band number on the transfusion order were not checked to verify that the information corresponded to the unit selected for transfusion to patient [redacted]. As a result, a unit of type A+ blood, which had been crossmatched to a different patient, was transfused to patient [redacted] who was blood type O+. The patient subsequently suffered a hemolytic transfusion reaction.
b. Your SOP titled "Compatibility Testing or Type and Screen Sample Collection and Processing" states that a blood bank armband must be attached to each patient and that [redacted]. The armband number corresponds to the patient blood sample, which is used for compatibility testing or blood type and screen. On December 8, 2007, your laboratory technologist directed a nurse to remove the armband from patient [redacted] as the armband number did not match the number on the unit of blood that was issued for transfusion to patient [redacted]. The laboratory technologist subsequently replaced the original armband with a new armband with an armband number that matched the number of a unit that was crossmatched to a different patient, but was incorrectly transfused to patient [redacted].
c. Your SOP titled. "Transfusion Reaction Investigation" states, [redacted]. On December 8, 2007 your laboratory technologist received a call from a nurse regarding symptoms related to a possible transfusion reaction in patient [redacted]. The technologist did not confirm that the transfusion had been discontinued or that the patient's physician was notified. Instead, the technologist advised that the patient's symptoms were due to a urticaric reaction and that the next unit of blood should be warmed prior to transfusion.
The violations 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 action to correct these violations. Failure to promptly correct these deviations may. result in regulatory action without further notice.
We also note. that under 21 CFR 606.171, you must report to FDA any event, associated with manufacturing, to include testing, processing, packing, labeling, storage, or with the holding or distribution, that occurs in-your facility or another facility under contract with you, and represents a deviation from current good manufacturing practice, applicable standards, or established specifications that may affect the safety, purity, or potency of distributed blood or blood components. Biological product deviations (BPD) should be reported as soon as possible but not to exceed 45 calendar days from the date you acquire information reasonably suggesting that a reportable event has occurred. For additional information and guidance on BPD reporting, refer to FDA's web page at http://www.fda.gov/cber/biodev/biodev.htm.
Please let this office know in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay, and the time within which the corrections will be completed. Please direct your response or any questions you may have to the Food and Drug Administration, Denver District Office, P.O. Box 25087, Denver, CO 80225-008, Attention: Nancy G. Schmidt, Compliance Officer. If you have any further questions, please feel free to contact Ms. Schmidt at (303) 236-3046.
H. Thomas Warwick
Denver District Director