Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Lynn W Solomon LLC on February 11, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 lack of records and Laboratory Director interview, the laboratory procedure manual signed on 11/01/2024 failed to have a personnel policy to assess personnel competency. Findings included: -The laboratory procedure manual review revealed that in the policy "PATHOLOGIST'S DUTIES" "as writen", the laboratory listed the Technical Supervisor responsibilities that included "Overseeing laboratory personnel performance and competency". No policy found on how and when to assess personnel competency. -Review of FORM CMS 209 signed by the Laboratory Director (LD) on 02/11/2025 revealed that the LD was also the Clinical Consultant, Technical Supervisor, General Supervisor and Testing Person (TP)#1. The laboratory had 3 TP (TP#1, TP#2 and TP#3). -Review of patient logs revealed that TP#1 started testing on 11/04/2024, TP#2 started testing on 11/13/2024 and TP#3 started testing on 12/03 /2024. During an interview on 02/11/2024 at 11:30 AM, with LD she confirmed that the laboratory procedure manual failed to have a personnel policy and that the laboratory had no records of competencies for the testing personnel. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --