Inspections, Compliance, Enforcement, and Criminal Investigations
Oconee Memorial Hospital 27-Apr-05
Department of Health and Human Services
Public Health Service
Atlanta District Offices
April 27, 2005
VIA FEDERAL EXPRESS
Jeanne L. Ward
President & CEO
Oconee Memorial Hospital
298 Memorial Drive
Seneca, SC 29672-9443
Dear Ms. Ward:
During a Food and Drug Adrninistration (FDA) inspection of your hospital's blood bank located at 298 Memorial Drive, Seneca, South Carolina on March 7-14, 2005, our investigator documented significant deviations from applicable current Good Manufacturing Practice (cGMP) regulations for blood and blood components, Title 21, Code of F0 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)(13)]. The deviations include, but are not limited to, the following:
1. Failure to follow written standard operating procedures (SOPs), including all steps to be followed in the compatibility testing and distribution of blood and blood components for transfusion, as required by 21 CFR 606.100(b). Specifically,
a. On February 17, 2005, the phlebotomist did not follow your hospital's procedure entitled "Patient Relations and Identification" when she failed to properly identify a patient as specified in the procedure for the collection of a blood sample for crossmatching. The blood sample was collected from the wrong patient who had a different blood type from the patient for whom the blood transfusion was intended. Incompatible blood was issued and transfused.
b. On February 19, 2005, the laboratory technician failed to follow your hospital's procedure entitled "specimen Collection for Compatibility Testing" when she replaced a missing [redacted] (sometimes referred to as a blood band) with a new [redacted] without crossmatching a new blood sample as specified in your procedure.
2. Personnel responsible for the compatibility testing of blood and blood components do not have adequate training and experience to ensure competent performance of their assigned functions, and to ensure that the final product has the safety, purity, potency, identity and effectiveness it purports or is represented to possess, as required by 21 CFR 606.20 (b). Specifically,
a. Training procedures do not specifically define all the procedures and functions required for the phlebotomist and laboratory positions. The phlebotomist and laboratory positions have a general checksheet list of functions or laboratory tests to perform. Procedures related to each position are not specified. The laboratory technician training checksheet does not specifically include the procedure entitled "Specimen Collection For Compatibility Testing", which specifies drawing a new blood sample for crossmatching if an [redacted] is missing.
b. Training documentation does not always include supporting documentation (such as written tests or signed statements) that indicate that the trainees have an understanding of all procedures required for the position. Until recently, the primary method used to document training is a checkrnark on a check sheet list of functions or or tests to be performed.
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that all blood products issued by your transfusion facility are in compliance with the Act and the cGMP regulations. Your failure to correct these deviations may result in regulatory action being taken by FDA without further notice. Possible action may include seizure or injunction.
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these deviations and to prevent their reoccurrence. You should also provide complete documentation to demonstrate that the promised corrective actions are being appropriately implemented, such as employee training records, written standard operating procedures, or other records demonstrating corrective action. If you cannot complete corrections within 15 working days, state the reason for the delay and the time period within which corrections will be completed.
Please send your response to Serene N. Ackall, Compliance Officer, at the address noted in the letterhead.