Neodiagnostix, Inc

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 review of the personnel report and competency assessment records and interview with the associate lab director (ALD), the technical supervisor failed to ensure that testing personnel were not self-evaluated for competency. Findings: 1. The laboratory personnel report (form CMS-209) listed three general supervisors (GS) all of whom were delegated and qualified to perform competency assessments. 2. The ALD stated that as part of the annual competency assessments, one GS would compile a collection of images from previous cases for evaluation by all testing personnel (TP). The TP evaluation results would be reviewed and signed off by the GS who compiled the images. The ALD stated that the three GS would rotate who compiled the images each year. 3. Records showed that in 2021 GS #3 performed a self- evaluation of competency. 4. During the survey on 05/25/2022 at 12:30 pm, the ALD confirmed that in 2021 GS #3 compiled the collection of images, evaluated the images, then performed a self-evaluation of 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 1 --

Summary Statement of Deficiencies 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)