Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratory's established Quality Assessment policies, review of QA records and interview with the facility personnel, the laboratory failed to identify and correct errors found within the accuracy verification process. Findings include: 1. The laboratory performs a microscopic examination and diagnosis on tissue specimens in conjunction with Mohs testing under the sub-specialty of Histopathology, with an approximate annual test volume of 2,400. 2. It is the practice of the laboratory to randomly select four completed Mohs cases each quarter which are reviewed by another qualified Mohs physician to verify accuracy of the testing. The review is documented on the "Quality Assurance, proficiency testing" form. 3. The laboratory's established policy titled, "Quality Assurance Program" states, "Peer review will be documented as proficiency testing is scheduled....A