Company: Mercy Medical Center
Product: Blood bank facility
Date: 07/25/03
Failure to maintain an adequate number of trained and experienced personnel for the processing, compatibility testing, storage, and distribution of blood or blood components. For example, employee…who was responsible for completing validation of the …software, was also responsible for Quality Assurance, supervisory and administrative duties, training of personnel, tissue bank duties, and SOP development, in addition to performing approximately 80% of the laboratory workload (i.e., group and type, antibody screening, and compatibility testing of patient specimens). Additionally, the facility failed to train the aforementioned employee to perform validation of the … blood bank software … [21 CFR 606.20(b)]
Failure to check the accuracy of input to and output from your computer or related system of formulas or other records or data. For example, the …which was put into use in November 2002 has not been validated. The standard operating procedure (SOP) entitled ‘… outlined the steps to be followed in the validation of the blood bank computer system, however, numerous validation records and forms pertaining to the validation of the computer system were incomplete and/or did not note the signatures of personnel who had performed or reviewed the validation. [21 CFR 211.68(b) and 606.100(b)]
In your response, you stated that “Input and output from the computer were checked at the time of the upgrade. Paper work is being organized and labeled for documentation.” However, during the inspection of your facility, you could not provide the investigator with adequate documentation supporting the validation of the…Please provide detailed information supporting the validation of the …
FDA District: Baltimore
