HospitalInspections.org

Through a review of the "CONFIDENTIAL QUALITY PERFORMANCE IMPROVEMENT REPORTING SYSTEM", laboratory policies and procedures, the incident report submitted by the Pathologist on 05/10/2012, a narrative recorded by the Director of Diagnostic Imaging and interviews with hospital staff, it was determined the Quality Improvement Program failed to include patient care data submitted according to the hospitals Confidential Quality Performance Improvement Reporting System. Failure to submit quality concerns to the Quality Improvement Program could result in improper handling of biopsy specimens obtained in the Mammography Department. This failed practice has the potential to affect all patients having stereotactic biopsies performed (approximately 52 cases per year). Survey findings follow:

A. The policy titled "CONFIDENTIAL QUALITY PERFORMANCE IMPROVEMENT REPORTING SYSTEM" stated, "1. The employee first observing a quality occurrence deviation is responsible for: Providing appropriate initial interventions to ensure patient, visitor and employee safety. Promptly reporting the quality occurrence to his/her supervisor... 2. The reporting department supervisor (or supervisor on duty during nights, weekends and holidays) is responsible for: Initial review and investigation of the occurrence. Ensuring appropriate interventions are taken and documented in the appropriate place. Consulting with other departments involved and completing the investigation sheet. Documenting conclusion, facts and opportunities for improvement on the designated investigation/summary form. Forwarding all QP report and investigation/summary report to the Quality Performance Improvement office within 48 hours of the occurrence."

B. The Laboratory policy titled "RECEIPT AND HANDLING OF SPECIMENS" stated, "Fresh specimens must not be left at room temperature for any reason. In the rare event a specimen might be left unrefrigerated, the appropriate department will be notified for investigation and correction of inappropriate specimen handling."

C. The incident report submitted on 05/10/2012 (one month after the incident) by the Pathologist stated that on 04/10/2012 a specimen container was received by Pathology without a specimen in the container. It stated Radiology was informed of the missing specimen (the biopsy was performed in Radiology/Mammography). It further stated the specimen was found in a trash can and placed in formalin at 17:10 although the biopsy was performed at 09:16.

D. The narrative dated 04/11/2012 which was signed by the Director Diagnostic Imaging stated he was notified that a specimen taken during a stereotactic biopsy did not make it to the Laboratory. It further stated the specimen was later found in the trash.

E. Although the "CONFIDENTIAL QUALITY PERFORMANCE IMPROVEMENT REPORTING SYSTEM" stated the Department Supervisor is responsible for forwarding all QP report and investigation/summary report to the Quality Performance Improvement office within 48 hours of the occurrence, the Director of Diagnostic Imaging never submitted a QP report and the Pathologist failed to submit a report until one month after the incident.

F. Two patients had stereotactic breast biopsies performed between the date of the incident (04/10/2012) and the date the Quality Performance Improvement office was informed of the incident (05/10/2012). Patient #5128151 had a biopsy performed on 04/17/2012 and Patient #5130025 had a biopsy performed on 05/1/2012.

G. In an interview at 13:56 on 05/14/2012, the Director of Diagnostic Imaging stated approximately 52 stereotactic biopsy procedures are performed annually.