Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, the Centers for Medicare and Medicaid Services form 209 Laboratory Personnel Report (CMS-209) and interview with the laboratory's lead testing person (TP#1), the laboratory failed to test proficiency testing samples by routine testing personnel in 2021 and 2022. The finding include: 1. Review of the laboratory's PT records revealed that testing personnel number two and three did not participate in six of six Hematology PT events (2021 events one, two, and three; 2022 events one, two, and three). 2. Review of the CMS-209 revealed four personnel who perform patient testing. 3. Interview with the laboratory's lead testing person (TP#1) at approximately 11:30 am on June 21, 2023 confirmed that testing personnel number two and three did not participate in six of six Hematology PT events, resulting in the laboratory failing to test proficiency testing samples by the same personnel who perform patient testing in 2021 and 2022. 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 2 -- This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services form 209 Laboratory Personnel Report (CMS-209), the laboratory's policies, the testing personnel (TP) records, and interview with the laboratory's lead testing person (TP#1), the laboratory failed to follow their policy for personnel competency assessment for four of four testing personnel in 2021 and 2022. The findings include: 1. Review of CMS 209 report revealed four testing personnel performing moderately complex patient testing for complete blood counts (CBCs). 2. Review of the laboratory's "Competency Verification Policy" stated, "Each year an annual evaluation form will be completed per employee (employees that perform lab testing only). This form will be placed in the employee file." 3. Review of testing personnel competency assessments revealed no annual competency assessments for testing personnel one, two, three in 2021 and 2022 and no annual competency assessment for testing personnel four in 2022. 4. Interview with the laboratory's lead testing person (TP#1) at approximately 11:30 am on 06.21.2023 confirmed the laboratory failed to follow their policy for personnel competency assessment in 2021 and 2022. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)