Uinta Basin Medical Center Manila Clinic

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on record review, direct observation, and interview with testing personnel 1 (TP1), room temperature and humidity were not monitored. Refrigerator temperature was not monitored. The laboratory performs approximately 15 Complete Blood Counts (CBC) tests annually. Findings include: 1. Record review did not include daily room temperature and humidity for the room where instrumentation was located. Refrigerator temperature was not recorded daily. 2. Refrigerator thermometer calibration sticker stated the thermometer expired 04/29/2015 and the thermometer probe expired 11/11/2019. 3. CELL-DYN controls and calibrators are stored at 2- 8 C. 4. In an interview on 09/09/2021 at approximately 12:50 PM, TP1 confirmed that the thermometer and probe had not been calibrated. 5. The TP1 confirmed that the daily temperature check is only performed by one clinic staff. Testing is performed regardless if temperature checks are completed and that staff is working that day. 6. No thermometer or hygrometer was present in the room with the laboratory during observation. 7. The CELL-DYN Emerald manufacturer requires the instrument to operate at temperature range of 18 - 32 C and a maximum relative humidity of 80%. 8. In an interview on 9/09/2021 at approximately 1:15 PM, testing personnel 1 confirmed that room temperature and humidity was not monitored. 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 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 from API on 7/16/2021, 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 in hematology) with scores of 73% and 53% respectively. 2. API scores were confirmed via the API website portal documenting scores for WBC differential of 73% for the 3rd event of 2020 and 53% for the first event of 2021 on 7/16/2021. -- 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 lack of documentation, test records review, and confirmation by the laboratory director, the laboratory failed to retain the complete blood count (CBC) quality control assay sheets to determine quality control ranges set for each lot number of quality control (QC) materials was accurately printed on the QC test reports for 3 of 11 QC lot numbers reviewed from 04/20/2017 to 12/03/2018 when the laboratory temporarily discontinued testing.. Findings include: 1. The laboratory failed to retain the QC manufacturer's assay sheets for QC lot numbers: 7240 in use on 10/31/2017 for patient 113307; and 11/16/2017 for patient 125544; 8015 in use on 03 /16/2018 for patient 126271; 8071 in use on 05/25/2018 for patient 2161994 and on 06 /21/2018 for patient 212999; 8127 on 07/09/2018 for patient 47028; 8183 in use on 10 /08/2018 for patient 05181959 (date of birth); and 8239 in use on 12/03/2018 for patient 99625. 2. In an interview conducted on 04/04/2019 at approximately 12:25 P. M., the laboratory director confirmed the testing person failed to retain assay sheets for QC materials in use after 01/04/2018, 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 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: The laboratory failed to successfully participate in proficiency testing (PT) for white blood cell differential by failing to achieve satisfactory performance in 2 of 3 PT events (event 2 of 2017 and event 1 of 2018). (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 Federal CASPER report 155 review and American Proficiency Institute (API) proficiency testing (PT) results review, the laboratory failed to achieve a satisfactory score of at least 80% in 2 of 3 consecutive events for white blood cell differential (Diff). Findings include: 1. API and CASPER reports document an unsatisfactory score of 73% for PT event 2 of 2017 for Diff. 2. API and CASPER reports document an unsatisfactory score of 0% for PT event 1 of 2018 for Diff. -- 2 of 2 --