Summary:
Summary Statement of Deficiencies 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 the laboratory's competency assessment records, and interview with the laboratory manager (LM), the laboratory failed to establish and follow written policies and procedures to assess the competency of 1 of 1 technical supervisor (TS) for their supervisory responsibilities listed in Subpart M from 01/01 /2021 through the time of the survey. Findings Include: 1. On the day of the survey, 07 /18/2023 at 12:00 pm, the laboratory could not provide a competency assessment procedure to assess the competency of 1 of 1 TS (CMS personnel # 4) for their supervisory responsibilities listed in Subpart M from 01/01/2021 to 07/18/2023. 2. The laboratory could not provide records of competency assessments performed for 1 of 1 TS from 01/01/2021 to the date of the survey. 3. The LM interviewed on 7/18 /2023 around 01:00 pm confirmed the findings above. D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of the Beckman Coulter DxH 520 operator manual and interview with the laboratory manager (LM), the laboratory failed to have a complete written procedure manual for Complete Blood Count (CBC) testing that met the requirements of 493.1251 from 01/01/2021 to the date of the survey. Findings include: 1. On the day of the survey, 7/18/2023 at 11:00 AM, review of the Beckman Coulter DxH 520 operators manual revealed that the test system instructions used to perform CBC's failed to include the following requirements of 493.1251 from 01/01/2021 to 07/18 /2023: - Step by step performance of the procedure including test calculations and interpretation of results - Preparation of slides, solution, calibrators, controls, reagents, stains, and other material used in testing. - Control procedures -