Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 19, 2024. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) 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 personnel records review and interview with the office manager, the lab director failed to ensure that ALL pre analytic, analytic and post analytic Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory from August 2023 thru the date of survey September 19, 2024 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Personnel documents review revealed the lab director , who is also the (TS), had no proof that semi annual and annual competencies were performed on all testing personnel (TPs #s 6 and 7 CMS 209) from August 14, 2023 thru the day of survey September 19, 2024. 2. An interview with the laboratory's office manager, in the review room, on 09/19 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 -- /2024, at approximately 12:15 PM, confirmed the lab director , who is also the Technical Supervisor (TS), failed to ensure proper oversight of the laboratory from August 2023 thru the date of survey 9/19/2024. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on personnel records review and interview with the office manager, the laboratory failed to ensure that semi-annual and annual competencies for testing personnel (TPs) performing (PPM) testing from August 14, 2023 thru the date of survey September 19, 2024 were performed by the Technical Supervisor or Laboratory Director. Findings: 1. A review of Provider Performed Microscopy (PPM) training and competency assessment records revealed that TPs #s 6 and 7 (CMS-209 form) were signed off after training on August 14, 2023. There were no semi annual or annual competencies for either of the testing personnel by the Laboratory Director , who is the Technical Supervisor (TS). 2. An interview with the office manager, in the review room, at approximately 12:10 PM, on 09/19/2024, confirmed semi annual and annual competencies for TPs #s 6 and 7 (CMS -209 form ) were performed but not documented on day of survey 09/19/2024. -- 2 of 2 --