Summary:
Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, physician peer review documentation, and interview with testing personnel (TP) #2; the laboratory failed to perform bi-annual evaluations of Mohs histopathology testing for the years of 2022 and 2023 as required per 493.1236 (See D5217). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, physician peer review documentation, and interview with testing personnel (TP) #2; the laboratory failed to perform bi-annual evaluations of Mohs histopathology testing for the years of 2022 and 2023 as required per 493.1236. Findings include: 1. Review of the laboratory's policy and procedure manual found the policy, "General Lab & Quality Assurance Policy", which stated, under "Peer Review": "At least biannually, the lab will verify the accuracy of histopathology Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- resulting by peer review to assess the competency of each physician. Each physician will review 5 random applicable cases such as Mohs and/or dermatopathology cases of a peer." 2. An interview with TP #2 at 08:27 am on 01/11/2024 revealed histopathology testing at the Moline office (132 7th Street - Moline, IL 61265) began in late summer of 2022. 3. Upon review of "Bi-Annual Peer Review and Competency Assessment" documents for Dr. Joshua Kentosh (TP #1), it was revealed that no bi- annual peer reviews were performed in 2022 and 2023 for this laboratory. 4. An interview with TP #2 at 08:41 am on 01/11/2024 confirmed the above findings. -- 2 of 2 --