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 lack of policies presented for review pertaining to accuracy checks for frozen biopsy reading and Mohs surgery slide reading and interview with laboratory personnel, the laboratory failed to establish a policy regarding procedures to follow when there is a discrepancy between the primary reader's diagnosis and the second reader's verification of the first reader's diagnosis for the accuracy checks performed under the sub-specialty of Histopathology. Findings include: 1. The laboratory performs accuracy checks at least twice yearly for testing personnel performing the reading of frozen biopsies and Mohs surgery slide reading. 2. The laboratory personnel stated that there were occasional discrepancies between the primary reader's diagnosis and the secondary reader's diagnosis but acknowledged that there was no policy in place regarding procedures to follow when discrepancies occur. 3. There was no tracking or recording data presented for review regarding the number of discrepancies or if the discrepancies resulted in a diagnostic change. 4. The laboratory's total annual test volume under the sub-specialty of Histopathology is 700. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --