Summary:
Summary Statement of Deficiencies D0000 A validation survey was conducted on August 15, 2025. Standard-level deficiencies were cited. 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 Proficiency Testing and Quality Assurance policies, Proficiency Testing report/Peer Review for MOHS Micrographic Survey forms, and interview with the lead Medical Assistant, the laboratory failed to follow its established Quality Assurance policy and procedural requirements for one of one proficiency testing report/MOHS peer review. Findings included: 1. A review of the laboratory's Proficiency Testing Policy revealed the requirement of, "the peer review documentation will be signed and dated by: the reviewing MOHS Surgeon, Dermatologist, Pathologist or Dermatopathologist; the original MOHS Surgeon; and the Laboratory Director." 2. A review the laboratory's Proficiency Testing and Quality Assurance procedure specified, "Any comments documented during either the QA and Proficiency Testing will be reviewed and signed by the Lab Director." 3. A review of a master copy of the laboratory's Proficiency Testing report/Peer Review for MOHs Micrographic Surgery form showed a designated Lab Director Review Signature line. However, examination of a completed MOHs Micrographic Surgery form for Testing Personnel #1 (TP #1) covering the period January 2025 to June 2025 revealed the Lab Director Review Signature Line had been whited out and replaced with an electronic signature for TP #1. 4. During an interview conducted on 08/15/2025 at 11:30 AM, 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 -- the Lead Medical Assistant confirmed the laboratory failed to follow its own established Quality Assurance procedures by allowing TP #1 to sign their own peer review form and not the Laboratory Director. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require