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 the surveyor's review of the laboratory's policy and procedure, patient record, lack of personnel competency documentation, and an interview with the office manager (OM) on March 9, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform the personnel competency assessment prior to patient testing. The findings include: 1. The laboratory had an existing competency assessment protocol for the tests under provider-performed microscopy (PPM) which included the potassium hydroxide (KOH) and scabies tests but was not followed since 2023 resulting to lack of records for all testing personnel (TP) performing the tests. 2. The surveyor reviewed the KOH patient test record and determined that the test performed for the PPM test was performed by the TP without any record of competency assessment documentation for the years 2023, 2024 and 2025. 3. The OM affirmed in an interview on March 9, 2026, at approximately 4:20 p.m. that the laboratory lacked competency assessments for the years 2023, 2024 and 2025 for all testing personnel performing PPM tests. 4. The quality and reliability of patient samples processed and reported could not be assured due to lack of personnel competency assessment as required in this subpart. . D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test 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 -- result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, preventive maintenance (PM) documentation, seven patient records, and an interview with the office manager (OM), it was determined that the laboratory failed to ensure performed tests and function checks were documented or maintained prior to patient testing. The findings include: 1. It was the practice of the laboratory to have a biennial PM service for the microscope, Olympus EH, serial number: 250423. However, this was not followed as the last service found was documented on 6/9/2023 but had no follow-up PM since 6/9/2025. 2. No