Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on June 16, 2022 at Desoto Regional Family Medicine, CLIA ID # 19D0463227. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 the laboratory's policies, CMS 209 form (Laboratory Personnel Report), personnel records, and interview with personnel, the laboratory failed to established a complete competency assessment policy for testing personnel. Findings: 1. Review of the CMS 209 laboratory personnel form provided to surveyor revealed the laboratory employed seven testing personnel. 2. Review of personnel competency assessment documentation revealed the laboratory utilized testing records from alternate locations to support testing personnel competency. Further review revealed patient testing dates for competency on days which the clinic was closed. 3. Review of the laboratory's competency assessment policy revealed the laboratory procedure does not include use of personnel data from alternate sites. 4. Interview with the laboratory technical consultants on June 16, 2022 at 11:45am confirmed that the laboratory utilized testing personnel records from the affiliated hospital and alternate clinics to complete competency assessments for some testing personnel who rotate testing sites. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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 laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of laboratory policy, CMS 209 (laboratory personnel form) and personnel records, as well as interview with laboratory personnel, the laboratory director failed to assigned the duties and responsibilities of all testing personnel. Findings: 1. Review of CMS 209 (laboratory personnel form) detailed seven (7) testing personnel of varying qualifications. 2. Review of laboratory policy and personnel records, including qualification and competency assessment, revealed that all testing personnel were not competent for all moderate complexity testing on the laboratory test menu. Further review revealed there was no delegation of duties and responsibilities for each testing personnel. 3. Interview with Technical Consultants at 12:15pm on June 16, 2022 confirmed that although there were different duties for laboratory assistants, there were no specific delegations of responsibilities for individual testing personnel. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Technical Consultant failed to ensure competency of testing personnel was evaluated by the laboratory annually. Findings: 1. Review of the CMS 209 laboratory personnel form provided to surveyor revealed the laboratory employed seven testing personnel. 2. Review of personnel competency assessment documentation revealed the laboratory utilized testing records from alternate locations to support testing personnel competency. Further review revealed patient testing dates for competency on days which the clinic was closed. 3. Review of the laboratory's competency assessment policy revealed the laboratory procedure does not include use of personnel data from alternate sites. 4. Interview with the laboratory technical consultants on June 16, 2022 at 11:45am confirmed that the laboratory utilized testing personnel records from the affiliated hospital and alternate clinics to complete competency assessments for some testing personnel who rotate testing sites. -- 2 of 2 --