Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed on May 24, 2023 at LSU School of Vet Med, LA Animal Disease Diag Lab, CLIA ID # 19D2187966. 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: 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 establish a written policy to assess competency for the Technical Supervisor and General Supervisor. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Technical Supervisor also serves as the General Supervisor. 2. Review of the laboratory's "Clinical Laboratory Quality Assurance Program" policy revealed the laboratory did not include performance of competency assessment for the Technical Supervisor and General Supervisor to include but not limited to frequency. 3. Review of the Technical Supervisor's personnel records revealed the Technical Supervisor did not have a competency assessment performed for her roles as Technical Supervisor and General Supervisor. 4. In interview on May 24, 2023 at 9:13 a.m., the Technical Supervisor confirmed she did not have a competency for her role as Technical Supervisor and General Supervisor. II. Based on review of the laboratory's polices and interview with laboratory personnel, the laboratory failed to ensure the quality assurance policy included frequency of performance for competency of testing personnel. Findings: 1. 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 -- Review of the laboratory's "Clinical Laboratory Quality Assurance Program" policy revealed the laboratory did not include frequency of performance of competency assessment for testing personnel. 2. In interview on May 24, 2023 at 9:13 a.m., the Technical Supervisor confirmed the policy did not include frequency of performance of competency assessment for testing personnel. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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. Findings: 1. The laboratory failed to establish a written policy to assess competency for the Technical Supervisor and General Supervisor. Refer to D5209 I. 2. The laboratory failed to ensure the quality assurance policy included frequency of performance for competency of testing personnel. Refer to D5209 II. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as 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 result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's CMS-209 form (Laboratory Personnel Report), personnel records, and interview with personnel, the Laboratory Director failed to delegate responsibilities to the Technical Supervisor and General Supervisor. Findings: 1. Review of the personnel records for the Technical Supervisor, also serving as General Supervisor, revealed the laboratory did not have documentation of the Laboratory Director delegating the tasks of Technical Supervisor and General Supervisor to her. 2. In interview on May 24, 2023 at 9:13 a.m., the Technical Supervisor confirmed the laboratory did not have the documentation identified above. -- 2 of 2 --