Arthritis Clinic Of Central Utah

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on American Proficiency Institute (API) performance summary review and confirmation by API on 11/23/2021, the laboratory failed to achieve successful participation in two consecutive events for Total Bilirubin proficiency testing performance. (See D2096). The laboratory conducts approximately 97,500 routine chemistry and urinalysis test annually. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) performance summary review and confirmation by API on 11/23/2021, the laboratory failed to achieve successful participation in two consecutive events for Total Bilirubin (TBil) proficiency testing performance. The laboratory conducts approximately 97,500 routine chemistry and urinalysis test annually. Findings include: 1. API summary report included documentation that the laboratory failed TBil in two consecutive events (second event of 2021 and third event of 2021 of Routine Chemistry evaluation) with scores of 60% and 40% respectively. 2. API records were reviewed online via the API website on 11 /23/2021 to verify the test results of 60% for the second event of 2021 and 40% for the third event of 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on Envoy instrument maintenance records review, lack of documentation and interview with staff, the laboratory failed to perform and document instrument maintenance as defined by the manufacturer for the Envoy instrument for 1 of 8 quarterly Sodium and Chloride electrode changes reviewed from January 2018 to January 2020, March 19. 2018. The laboratory performed approximately 8000 electrolyte tests per year. Findings include: 1. The Envoy manufacturer maintenance log review included a 3 month schedule for changing fSodium, Potassium, and Chloride electrodes. The log lacked documentation Sodium and Chloride electrodes were changed in the first quarter of 2018. 2. In an interview with staff on 01/23/2020 at approximately 2:45 P.M. staff confirmed they did not change sodium and Chloride electrodes the first quarter of 2018. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) 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 -- Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on calibration records review, lack of documentation, and interview with staff, the laboratory failed to verify calibration at least once every six months for the ABX Micros 60 hematology tests for 1 of 4 six month periods reviewed from January 2018 to January 2020, the first six months of 2018. The laboratory performed approximately 8000 Complete Blood Counts per year. Findings include: 1. Calibration records reviewed failed to include documentation the laboratory followed ABX manufacture's instructions to verify calibration once every 6 months. 2. In an interview with staff on 01/23/20220 at approximately 2:45 P.M., staff confirmed they missed performing calibration on the Complete Blood Count instrument the first six months of 2018. -- 2 of 2 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on proficiency test (PT) review and interview with staff, the laboratory failed to achieve satisfactory performance in 1 of 6 chemistry PT events reviewed (3rd event of 2017) by failing to submit test results, resulting in a score of 0%. Findings include: 1. Federal CASPER report and American Proficiency Institute (API) report review document scores of 0% for 15 of 15 chemistry analytes. 2. Staff stated on 06/28/2018 at approximately 11:00 a.m., they were busy working with a vendor on a new instrument installation and missed the result submission date. They had not suspended patient testing. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with staff, the laboratory failed to verify the accuracy of 1 of 17 tests performed (ESR) twice annually for 2 years of records reviewed (2016 and 2017). The laboratory performs approximately 40 ESR tests daily. Finding include: 1. The laboratory lacked documentation of they had verified ESR test accuracy in 2016 and 2017. 2. Staff stated on 06/28/2018 at approximately 2:00 p.m. they did not have a procedure for verifying ESR accuracy. 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)