Improving Quality in the Laboratory by Implementing a Novel System of Ownership, Chain of Custody and Verification of Process and Patient
Ann E Anderson, Savvas E Mendrinos, Michael S Nagar, Deepak A Kapoor, Ken Cerney. Integrated Medical Professionals, PLLC, Garden City, NY; Know Error, Indianapolis, IN
Background: Approximately 250,000 new cases of prostate cancer are diagnosed annually in USA. This number translates into over one million biopsies and each biopsy encompasses multiple sites. The process of collecting, handling, analyzing, diagnosing, reporting and acting upon tissue biopsies is complex and involves many steps. Despite the utilization of labeling systems, the opportunity for diagnostic mistakes due to occult specimen provenance complications persists. Our aim is to evaluate our novel system in order to identify the number of errors and minimize specimen provenance complications.
Design: Our unique process of specimen ownership involves the following steps: The Patient participates in self-identification via introduction to the Know Error identification process and DNA buccal swab. The Urologist participates via actively placing prostate cores directly into a pre-bar-coded, site-specific cassette after ordering the test electronically in the EMR. The courier participates by scanning each specimen both at the urology office and upon delivery to the pathology lab. The Pathology lab personnel participate by positively identifying each specimen via 2D barcode, verification of the office-based order and registration into the Pathology LIS. Each specimen is handled one at a time using the Ventana Vantage protocol. The Pathologist participates by scanning each case before reading it. Quality of reads is ensured by a second read of all abnormal findings, and 50% of random blind reads. The ultimate step of the chain of custody designed in this lab occurs when the positive cores are verified against the patient's self-identified buccal DNA sample.
Results: In a nine month period, 89 Urologists swabbed 3,754 patients. Of those, 1,282 patients had adenocarcinoma involving 5,198 cores collectively. Although initially there were 8 cores reported as 'mis-match', these were resolved with re-submission of adequate samples. In addition, 2 patient name errors and 8 DOB errors were identified prior to testing. There were no provenance errors in any of the 5,198 positive tissue cores processed.
Conclusions: Implementation of the "IMP Pathology Laboratory Quality System" led to no provenance errors, verifying the effectiveness of the system. The system is LEAN, removing any superfluous steps, it provides an absolute chain of custody of patient tissue samples from the time of biopsy to the verification of positive patient cores.
Category: Quality Assurance
Monday, March 19, 2012 1:00 PM
Poster Session II # 241, Monday Afternoon