Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at John W McDonald MD FAAD PA on January 21, 2026. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D5200 493. 1230 - General Laboratory Systems 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 and interview, the laboratory failed to maintain documentation to verify accuracy of the reading and interpretation (peer review) of the Hematoxylin and Eosin stain at least twice annually for 2024 and 2025. (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 and interview, the laboratory failed to maintain 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 -- documentation to verify accuracy of the reading and interpretation (peer review) of the Hematoxylin and Eosin stain at least twice annually for 2024 and 2025. This is a repeat deficiency from the survey on 11/07/2023. Findings included: 1. Review of the patient logs revealed there were seven Mohs surgical procedures performed in 2024 and one Mohs surgical procedure performed in 2025. 2. Review of peer review records revealed there was no evidence of peer review performed in 2024 or 2025. 3. On 01/21/2026 at 11:25 AM, the Laboratory Director stated he did not do any peer review in 2024 and 2025. -- 2 of 2 --