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: Item 1 Based on surveyor review of personnel records and procedures and interview with a testing personnel (Staff A), the laboratory did not establish and follow written procedures to assess employee competency for two of two personnel performing technical consultant responsibilities. Findings include: 1. Review of laboratory records showed two individuals (Staff B and Staff C) perfromed technical consultant responsibilities. Further review showed no evidence that the laboratory director evaluated the competency of the individuals performing technical consultant responsibilities. 2. Review of the laboratory's policy, 'Laboratory Competency Policy,' revealed no evidence of a procedure that defined the process for competency evaluation of the technical consultants. 3. Interview with Staff A on July 9, 2026, at 11:45 AM confirmed the laboratory did not have a written procedure for competency evaluation of personnel performing technical consultant responsibilities. Item 2 Based on surveyor review of the laboratory's competency assessment procedures and records, and interview with a testing personnel (Staff A), the laboratory did not follow its written policies and procedures to assess employee competency for one of one testing personnel. Findings include: 1. Review of 'Laboratory Competency Policy,' showed the policy stated, "A Six Month and Annual Laboratory Competency Assessment will be conducted on each employee performing patient testing. The six month competency evaluation should take place approximately six months after the employee has been trained to perform the testing. The annual competency evaluation should be as close to the one year mark from initial training as possible. The annual Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- competency evaluation must not exceed the one year mark." 2. Review of training and competency assessment records for Staff A showed: -'Viva-ProE TRAINING CHECKLIST', completed on November 3, 2023 -'POL and Clinic Laboratory Competency Assessment' form marked "six month assessment", completed April 23, 2024 -'POL and Clinic Laboratory Competency Assessment' form marked "annual", completed October 30, 2025. There was no evidence Staff A had an annual competency assessment within one year of the date on the initial training checklist, November 3, 2023. 3. Interview with Staff A on July 9, 2026, at 11:50 AM confirmed Staff A did not have an annual competency evaluation within one year of their initial training, confirming the laboratory did not follow its written procedures to assess employee testing personnel competency for one of one testing personnel. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)