Summary:
Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory tour and interview with the laboratory's medical assistant (MA) it was determined that the laboratory failed to establish safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to provide a written procedure for laboratory safety. 2. On the day of the survey July 25, 2024, at approximately 11:00 a.m. the surveyors observed that the laboratory lacked an eyewash and biological & chemical spill kits in the area where tissue samples are processed. 3. The MA affirmed the lack of safety procedures, eyewash, and spill kits in the testing area. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 07/25/2024, the laboratory processes and reports approximately 100 samples annually. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of patient testing records, patient final testing reports, and interviews with the medical assistant (MA) on July 25, 2024, at approximately 12:30 p.m. it was determined that for three (2) out of five (5) randomly selected patient Mohs testing records reviewed, the laboratory failed to follow written policies and procedures for specimen analytical phase testing, through completion of testing and reporting results. The findings included: 1. Review of Mohs documentation and patient's final test report found the following discrepancies: Patient 1 date of Mohs procedure performed on 6/17/2022; Mohs logs stated Stage VII as the final stage of SCC while the report indicated stage VII. Patient 2 date of Mohs procedure performed on 08/30/2023 stage II was missing one slide from storage. Records indicated four (4) slides were prepared labelled I A&B and II 1-2 and 2-2. Only three (3) were found at the time of the survey. 2. The MA affirmed that records were discrepant for two (2) patients an stated in #1 above 3. Based on the laboratory's annual test volume declaration signed by the LD on 7/25/2024 the laboratory performed and reported 100 Mohs procedures for which its accuracy cannot be affirmed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)