Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel competency assessment records, Standard Operating Procedures (SOPs), as well as interview with the General Managers (GMs), the laboratory failed to establish and approve procedures to assess Clinical Consultant (CC), Technical Supervisor (TS), and General Supervisor (GS) competency. FINDINGS: 1. There was no documentation of CC, TS, and GS competency assessment performance. 2. The current, approved SOPs did not include instructions for performing such activity. 3. It was noted that Testing Personnel (TP) competency assessment was performed and documented. 4. The GMs confirmed the findings on July 29, 2025, at approximately 4:00 P.M. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on review of Mohs Surgery Operative Reports as well as interview with the GMs, the laboratory failed to include facility name, address where testing was performed on the patient testing reports. FINDINGS: 1. There was no documentation of facility name, address where patient testing was performed on the Mohs Surgery Operative Reports. 2. The GMs confirmed the findings on July 29, 2025, at approximately 4:00 P.M. -- 2 of 2 --