Unity Health Specialty Care

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: . Through a review of proficiency testing attestation statements for all testing events in 2019 and 2020, a review of testing personnel authorization lists for blood gas testing, and through interviews with laboratory staff, it was determined that blood gas proficiency samples were not tested by personnel who routinely perform patient testing. Survey findings follow: A. The list of personnel who were approved, by the laboratory director, to perform Blood Gas analysis contains the names of laboratory personnel #4 through #10 (as listed on form CMS-209). B. A review of attestation statements for Chemistry Proficiency testing events (three of three events) in 2019 and (three of three events) in 2020 revealed that none of the personnel approved to perform Blood Gas analysis (personnel #4 through #10 from the form CMS-209) had performed Blood Gas Proficiency Testing in 2019 or 2020. The proficiency testing had been performed by the Blood Gas laboratory manager (personnel #3). C. In an interview, at 10:30 on 01/27/21, laboratory personnel #1 confirmed that personnel who routinely perform Blood Gas patient testing had not performed proficiency 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 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Through a review of the laboratory policy titled "Routine Urinalysis by CHEMSTRIP Urine Test Strips", observations made during a tour of the laboratory, and interviews with laboratory staff, it was determined the laboratory failed to ensure the urinalysis centrifuge speed is within the laboratory's established limits. Survey findings follow: A. The "Routine Urinalysis by CHEMSTRIP Urine Test Strips" policy states, "For microscopic analysis, centrifuge urine for 3 - 5 minutes at 1500 - 1700 rpm. B. During a tour of the laboratory (9:29 a.m. on 6/13/2018) the surveyor observed the sticker on the centrifuge which had the centrifuge speed recorded as 3412 rpm on 4/11/2018. C. Laboratory employee #6 (as listed on the form CMS-209) confirmed, at the time of the tour, that the speed of the centrifuge was outside of the speed required by the policy. D5783