Ogden Clinic Utah Hematology Oncology Ogden

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 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing records review, patient test records review, and confirmation by staff, the laboratory failed to ensure proficiency testing was performed by the same testing staff as routinely performed patient testing for 6 of 6 proficiency testing events reviewed from January 2016 to January 2018. Findings include: 1. Proficiency testing records reviewed included documentation the laboratory manager performed complete blood count (CBC) testing for American Proficiency Institute (API) CBC proficiency testing events from January 2016 to January 2018. 2. Patient test records review included documentation at least 11 different testing personnel performed CBC testing. 3.. In an interview with staff on 01 /18/2018 staff confirmed the lab manager had performed all 6 of the proficiency testing events over the past 2 years of testing. 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 --