Summary:
Summary Statement of Deficiencies D0000 . An onsite survey conducted 05/24/2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. . 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 a review of proficiency testing records, the Centers for Medicare and Medicaid Services (CMS) 209, and confirmed in interview, the laboratory failed to rotate proficiency testing samples through testing persons for nine of fourteen proficiency testing events reviewed from 2020 to 2022 The findings include: 1. Review of the CMS209 personnel list has four testing persons available for testing in 2020 and five testing persons available for testing in 2021 for the specialty of chemistry and hematology. 2. Review of the American Proficiency Institute (API) testing records from 2020 and 2022 has the following nine of fourteen events performed exclusively by testing personnel 2. 2020: Hematology Event 1: TP2 Chemistry Event 2: TP2 Hematology Event 2: TP2 Chemistry Event 3: TP2 Hematology Event 3: TP2 2021: Chemistry Event 1: TP2 Hematology Event 1: TP2 Chemistry Event 2: TP2 Hematology Event 2: TP2 3. In an interview on 5/24/2022 at 11:00 hours, in the office, testing personnel 1, as designated by the CMS209, confirmed that the laboratory was not rotating proficiency testing through the testing persons. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- 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)