University Of Md Health Center Laboratory

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)

Summary Statement of Deficiencies D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the annual evaluations and interview with the testing personnel, the technical consultant did not ensure that all testing personnel received an annual competency review by the qualified technical consultant. Findings: 1. The laboratory currently has two testing persons listed on the "Laboratory Personnel Report (CLIA) (CMS-209)." 2. The testing personnel evaluation records for 2018 were reviewed. One of the two testing persons had their annual review performed and documented by a testing person with an associate's degree. The technical consultant/evaluator is required to have a Bachelor of Science degree with two years' experience. 3. During the survey on 11/30/2018 at 12:00 PM the laboratory testing person confirmed that one of the two the annual evaluations for 2018 was not performed by the qualified technical consultant. 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 --