Ubmc Clinic Duchesne

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 7/15/2021, the laboratory failed to achieve successful participation in two consecutive events for white blood cell differential proficiency testing performance. (See D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- 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 7/15/2021, the laboratory failed to achieve successful participation in two consecutive events for white blood cell (WBC) differential proficiency testing performance. Findings include: 1. API summary report included documentation that the laboratory failed WBC differential in two consecutive events (third event of 2020 and first event of 2021 of hematology evalutaion) with scores of 73% and 73% respectively. 2. API records were reviewed online via the API website on 7/15/2021 to verify the test results of 73% for the third event of 2020 and 73% for the first event of 2021. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on Emerald complete blood counter reagent's record review, lack of documentation and interview with the director, the laboratory failed to ensure blood counting lyse reagent was not expired prior to testing patient samples for 11 of 24 months of testing reviewed (January 2018 to January 2020). The laboratory performed approximately 85 complete blood counts per year. Findings include: 1. Reagent records review included Lyse reagent documentation that lot number 7201 was in use on 3/22/2018 and expired on 06/30/2018. A new lot number was not recorded as placed in use until 06/03/2019. 2. In an interview conducted on 01/31/2020 at approximately 12:45 P.M. staff stated the laboratory did not record each time lyse reagents were changed. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on patient test records reviewed, patient instrument printouts reviewed, and interview with staff, the laboratory failed to ensure they followed their procedure to 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 -- perform instrument start up and three levels of quality control each day of patient complete blood cell count (CBC) testing for 1 of 11 patient's test reports reviewed (patient 68278) on 09/23/2019. Findings include: 1. Patient chart records include the instrument print out as documentation of the test report. 2. Patient test records instrument printouts include documentation the laboratory performed a CBC for patient #68278 on 09/23/2019, reporting a Red Blood Cell count of 4.96/ cubic millimeter x one million, Hemoglobin of 11.1 grams/deciliter, Hematocrit of 36.0%, and a mean corpuscular volume of 72.5 femtoliters. 3. In an interview with the laboratory director on 01/31/2020 at approximately 12:15 P.M. the director confirmed the patient was tested and the results were reported and that the laboratory failed to document they performed instrument start up, three levels of controls or recorded the environmental testing and storage temperatures or humidity on 09/23/2019. -- 2 of 2 --