Revere Health Lehi Oncology

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on test records reviewed and interview with staff, the laboratory test report failed to include the name and address of the laboratory location where Complete Blood Count (CBC) tests were performed for 10 of 10 CBC test reports reviewed. Findings include: 1. Patient test records reviewed included documentation the laboratory location was 115765 S State Street ST 103A, Draper, UT. 2. The laboratory location was in fact 96 E Kimballs Way, Suite 305A, Draper Utah. 3. In an interview conducted on 01/21/2020 at approximately 4:00 P.M. staff stated the laboratory location on the instrument report was not changed when the laboratory relocated to the current address approximately 4.5 years ago. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 -- This STANDARD is not met as evidenced by: Based on patient test records review and interview with staff, the laboratory failed to establish a written procedure for an ongoing mechanism to monitor, assess, and when indicated correct problems identified in the postanalytic system for the location where complete blood counts (CBC) are performed for 10 of 10 test reports reviewed. The laboratory performed approximately 3800 CBC tests per year. (See D5085) -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on environmental tracking records review, lack of temperature and humidity documentation and confirmation by staff, the laboratory failed to retain complete blood count quality control reagent storage records, testing ambient temperature and humidity records at least 2 years. Findings include: 1. Based on lack of documentation the laboratory failed to maintain records documenting quality control reagents were maintained between 2 and 8 Degrees Centigrade, the testing environment was maintained at less than 90% humidity (H) and between 20 to 28 degrees C as specified by the laboratory for testing performed in 2016. 2. In an interview conducted on 02/01/2018 at approximately 4:45 P.M. staff confirmed 2016 temperature and humidity documentation records could not be located for 2016 complete blood count 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 --