Summary:
Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at Southeastern Dermatology Group on 03/04/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on interview with the Mohs Technician (MT) and review of the Mercedes Scientific Platinumline Xylene Substitute (Xylene Substitute) product label, the laboratory failed to dispose of used Xylene Substitute in accordance with Mercedes Scientific manufacturer's guidelines. Findings Included: -During an interview on 03/04 /24 at 10:20 a.m., the MT stated the waste from the Linistat automated stainer was disposed of down the sink drain. -Review of the Xylene Substitute product label revealed the reagent should be disposed of to an approved waste disposal plant. 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 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 -- and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview with the Mohs Technician (MT), the Laboratory Director (LD) failed to document the responsibilities and duties of personnel required for high complexity testing laboratories for 2 out of 2 (2022-2024) years reviewed. Findings Included: - Review of job descriptions (last reviewed by the Laboratory Director 01/08/2024) showed that the responsibilities and duties for the Laboratory Director, General Supervisor, Clinical Consultant, and Testing Personnel were not documented. -Review of job descriptions showed that the Technical Supervisor's role, responsibilities, and duties required for high complexity testing were not included in the job description documentation. -Interview with the MT on 03 /04/24 at 10:45, confirmed the Laboratory Director, General Supervisor, Clinical Consultant, and Testing Personnel responsibilities and duties were not described in the job description document, and also, the Technical Supervisor role, responsibilities, and duties were not listed in the job description document. . -- 2 of 2 --