Summary:
Summary Statement of Deficiencies D0000 A Validation Survey was conducted on January 29, 2024 through February 2, 2024 at Jackson Parish Hospital - CLIA # 19D0464361. The laboratory was found in compliance with 42 CFR 493 Requirement 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: I. Based on review of the laboratory's CMS 209 form (Laboratory Personnel Report), policies, and personnel records, as well as interview with laboratory personnel, the laboratory failed to follow their competency assessment policy for six (6) of seven (7) Technical Consultants. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the laboratory listed the following personnel as Technical Consultants: Personnel 1 Personnel 2 Personnel 3 Personnel 4 Personnel 7 Personnel 8 Personnel 11 2. Review of the laboratory's "Testing Personnel Competency Assessment Schedule" policy revealed the following: - The TC is assessed for competency once per employment or when deemed necessary by the Laboratory Medical Director. 3. Review of personnel records revealed Technical Consultant competency assessment was not performed for the following personnel: Personnel 1 Personnel 2 Personnel 3 Personnel 4 Personnel 7 Personnel 8 4. In interview on January 30, 2024 at 10:29 a.m., the Laboratory Manager confirmed the laboratory did not have documentation of Technical Consultant competency assessments for the personnel identified above. II. Based on review of the laboratory's CMS 209 form (Laboratory Personnel Report), policies, and personnel records, as well as interview with laboratory personnel, the laboratory failed to follow their Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- competency assessment policy for two (2) of three (3) General Supervisors. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the laboratory listed the following personnel as General Supervisors: Personnel 5 Personnel 9 Personnel 10 2. Review of the laboratory's "Testing Personnel Competency Assessment Schedule" policy revealed the following: - The GS will be assessed for competency once per employment or when deemed necessary by the Laboratory Medical Director. 3. Review of personnel records revealed General Supervisor competency assessments were not performed for the following pesonnel: Personnel 5 Personnel 10 4. In interview on January 30, 2024 at 10:29 a.m., the Laboratory Manager confirmed the laboratory did not have documentation of General Supervisor competency assessments for the personnel identified above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)