Summary:
Summary Statement of Deficiencies D0000 An Initial certification survey was conducted January 14, 2025 at Dermatology Clinic - Lake Charles I - CLIA ID # 19D2308152. 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: Based on review of laboratory policies and personnel records as well as interview with personnel, the laboratory failed to follow their competency assessment policy for one (1) of one (1) personnel serving as General Supervisor. Findings: 1. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed one (1) testing personnel serving as General Supervisor. 2. Review of the laboratory's policy "Competency" section 5.4 revealed "Competency must be assessed for Technical Supervisor, General Supervisor, Technical Consultant and Clinical Consultant as well for all delegated duties at least annually...." 3. Review of personnel records revealed a competency assessment for the personnel serving as General Supervisor was not performed. 4. In interview on January 14, 2025 at 1:14 p.m., the Testing Personnel confirmed a competency for his role as General Supervisor was not performed. D5219 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(2) (c)(2) Any test or procedure listed in subpart I of this part for which compatible proficiency testing samples are not offered by a CMS-approved proficiency testing 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 -- program. This STANDARD is not met as evidenced by: Based on review of laboratory policies and proficiency testing records, the laboratory failed to document all steps performed for alternative assessment of Histopathology testing for one (1) of one (1) event reviewed. Findings: 1. Review of laboratory policy "Proficiency Testing" section 5.4 revealed the following instructions for proficiency testing alternate performance assessment: - "For those analytes/tests where commercially available proficiency testing material are not options, perform alternative performance assessment twice per calendar year." - "Select patient samples OR verified standards or control material at know concentrations that contain the specific analytes to be split and submitted to a single CLIA-certified reference laboratory for comparative testing, or comparison to appropriate peer group of CLIA- certified laboratories, if available." 2. Further review of the policy "Proficiency Testing" revealed the laboratory did not include the following: a) The number of cases /patients to be reviewed b) The name of the CLIA certified laboratory performing the comparison 3. Review of proficiency testing records for July 2024 revealed the name and address of a sister facility and did not include documentation of the location where the original slides were tested. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's polices and proficiency testing records as well as interview with personnel, the laboratory failed to perform an assessment of performance for one (1) of one (1) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's policy "Proficiency Testing" section 5.4.11 revealed "Evaluation - Review of the results, signed by the Laboratory Director and Testing Personnel." 2. Review of the proficiency testing event for July 2024 revealed no assessment of performance by laboratory personnel to include the Laboratory Director and/or testing personnel. 3. In interview on January 14, 2025 at 2:13 p.m., the Testing Personnel confirmed the laboratory did not have documentation of review by the Laboratory Director and/or Testing Personnel. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with laboratory personnel, the laboratory failed to ensure laboratory policies and procedures were approved and signed by the laboratory director. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory director did -- 2 of 4 -- not sign the policies and procedures in use. 2. In interview on January 14, 2025 at 2: 15 p.m., the Testing Personnel confirmed the laboratory director did not sign the laboratory's policies and procedures. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction to the laboratory. Refer to D5219. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require