HospitalInspections.org

Bringing transparency to federal inspections

595 WEST STATE ST

DOYLESTOWN, PA 18901

LABORATORY SERVICES

Tag No.: A0576

Based on review of facility documents and medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure safe blood transfusion services for one of 20 medical records reviewed (MR1).

Findings include:

Review of facility laboratory policy "Special Antigen Typing," revised January 2010 revealed the procedure for testing red blood cells for possessing antigens. "Procedure: 4. Record the results on 'Reagent Record Sheet' in the Blood Bank QC [Quality Control] Book and on the Antigen Typing Log Sheet (One sheet for each patient tested)" ... and additional references noted for further information in the "Technical Manual: American Association of Blood Banks, See individual policy and procedure package inserts for additional references."

Review of laboratory policy "Anti C, E, c -, e, BioClone," revised February 2007 revealed the test was used to determined if the same of red blood cells possessing antigens will agglutinate in the presence of antibody directed toward the antigens "... Procedure ... 2. To a properly labeled test tube, add one drop of the appropriate anti-sera reagent."

1) Review of MR1 revealed the patient was admitted to the facility on October 17, 2010, through the Emergency Department. Review of a physician blood bank order for MR1 dated October 17, 2010, revealed "Type and Crossmatch Urgent Quantity 2." Review of nursing documentation for MR1 dated October 17, 2010, revealed that the patient experienced "chills, cough, bilateral arm pain" during transfusion of the second unit. Review of physician documentation for MR1 dated October 17, 2010, revealed the patient received an incompatible unit of blood causing a hemolytic blood transfusion reaction. Review of physician documentation for MR1 dated October 19, 2010, revealed that the patient required insertion of a hemodialysis catheter and had received one hemodialysis treatment at the time of the investigation on October 17, 2010.

2) Interview with EMP5 on October 21, 2010, at approximately 11:00 AM confirmed that the Medical Laboratory Technician (MLT) did not follow common laboratory practices and departmental policy by not labeling all tubes and blood segments during the antigen testing procedure and by not discarding the incompatible blood unit from the work area that led to the subsequent hemolytic blood transfusion reaction for the patient in MR1. Further interview with EMP5 confirmed that the MLT, a recent graduate, was the only staff on duty in the Blood Bank on October 17, 2010, and the MLT did not feel comfortable performing the procedure.