Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on document review and interview with the laboratory director (LD) and testing personnel #1 (CMS 209 #1), the laboratory failed to provide a procedure manual, quality control documentation and manufacturer function tests for the Contour glucometer from 11/02/2022 to the day of survey. Findings include: 1. On the day of survey, 07/27/2024 the laboratory failed to provide a manufacturer provided instruction manual for the Contour glucometer. 2. The Contour glucometer instruction manual states: "You should perform a control test when: - Using your meter for the first time. - You open a new bottle or package of test strips. - You think your meter may not be working properly. - You have repeated, unexpected blood glucose results. 3. The laboratory failed to provide documentation of QC for Contour glucometer from 11/01/2022 to the day of survey. 4. The Contour glucometer instruction manual states: "Clean and disinfect your meter once a week." 5. The laboratory failed to provide documentation of manufacturer required function tests for the Contour glucometer from 11/02/2022 to the day of survey. 6. The LD confirmed the above findings on 7/27 /2024 at 2:45 pm. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to establish and maintain a procedure to assess the competency of the laboratory's Technical Consultant (TC) for their supervisory responsibilities performed in 2024. Findings include: 1. On the day of survey, 07/26/2024, the laboratory failed to provide a written policy that reviews how to assess the competency of the laboratory supervisors for their regulatory responsibilities in 2024. 2. The LD confirmed the findings above on 07/26/2024 at 10:54 am. 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: Based on review of the laboratory's procedure and manufacturer's operator manuals, and interviews with the laboratory director (LD) and testing personnel #1 (TP), the laboratory failed to have a complete written procedure manual for hematology testing performed that met the requirements of 493.1251 from 11/02/2022 to the day of the survey. Findings include: 1. On the day of the survey, 07/26/2024 at 12:00 pm, review of the laboratory's procedure manuals revealed the operators manual were used to perform testing on the following from 11/02/2022 to day of survey: - CBC on the CDS Medonic M-Series.. 2. Review of the operators manual revealed that the test system instructions used failed to include the following requirements: - Step by step performance of the procedure including test calculations and interpretation of results. - Control procedures. -