Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on April 28, 2021 at Madison Parish Hospital (Respiratory), CLIA ID # 19D0674150. 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 and personnel records and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant were complete. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include competency assessment criteria and frequency of performance for personnel serving as the Clinical Consultant. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed that Personnel 10 serves as the Clinical Consultant. 3. Review of personnel records for the Clinical Consultant revealed no documentation of a competency assessment for his duties as Clinical Consultant. 4. In interview on April 28, 2021 at 10:45 am, Personnel 2 confirmed the Laboratory Director did not perform a competency assessment for his duties as Clinical Consultant. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were maintained. Refer to D5209. -- 2 of 2 --