Elite Urgent Care Inc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on May 16, 2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - C.F.R. 493.803 Conditions: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) -0155D and WSLH Proficiency Testing records (2023-1, 2023-3 and 2024- 1), the laboratory failed to successfully participate in a proficiency testing program 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 -- approved by HHS, for each specialty, subspecialty or test which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty Hematology for the analyte - white cell differential (WBC DIFF) . Refer to 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. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and WSLH Proficiency Testing report, the laboratory failed to achieve satisfactory performance in three of four events events (2023-1, 2023-3, and 2024-1) for the analyte WBC DIFF. The finding include: a. 4% on the 2023 first event 16% on the 2023 third event 16% on the 2024 first event b. A review of the 2023 and 2024 scores from WSLH Proficiency Testing confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and WSLH Proficiency Testing records for 2023-1, 2023-3, and 2024-1 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CASPER 0155D report and WSLH Proficiency Testing records for 2023-1, 2023-3, and 2024-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D1002 REPORTING OF SARS-CoV-2 TEST RESULTS During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation of three systems to test for SARS-CoV2, review of 2021-2022 laboratory test records, the lack of laboratory documents, and interview with the Laboratory Director (Owner), it was determined that the Condition for reporting COVID-19 test results to the Secretary of HHS was not met. Findings included: 1. The laboratory used three different tests for SARS-CoV2: Manufacturer Test name ---------------------------------------------------------------- Mesa Biotech Accula SARS- CoV2, PCR Quidel Sofia SARS Antigen FIA Quidel Sofia2 Flu + SARS Antigen FIA 2. Laboratory records selected randomly from 2021 - 2022 documented SARS-CoV2 testing and results, as follows: Date Time SARS-CoV2 Result 2/13/21 1:25 PM Positive 5/02/21 5:35 PM Negative 7/09/21 9:45 AM Negative 9/26/21 6:00 PM Positive 12/03/21 2:30 PM Positive 1/29/22 9:55 AM Negative 3/24/22 4:25 PM Positive 5/05/22 11:20 PM Positive 6/07/22 1:45 PM Negative 6/07/22 1:00 PM Positive 3. For 10 out of 10 tests from the timeframe February 2021 to June 2022, the laboratory failed to provide evidence of reporting COVID test results to public health. 4. The Laboratory Director/Owner affirmed (6/07/22 at 7:00PM) that no COVID test results had been reported to public health; and thus, the failure to report COVID test results to the Secretary of HHS. 5. The laboratory performed and failed to report to public health: 2,550 COVID tests results annually (Testing Declaration, 6/02/22). . D2122 HEMATOLOGY CFR(s): 493.851(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on observation of the Sysmex XP300 hematology analyzer, review of 2021 - 2022 hematology tests records, proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and WSLH (Wisconsin State Laboratory of Hygiene); and interview with the Laboratory Director (Owner), it was determined that the laboratory failed to attain scores of 80% or better in hematology proficiency testing. Findings included: 1. For 2021 - Event 1, Hematology, CMS and WSLH reported scores of 0% for RBC, WBC, WBC Differential, Hemoglobin, Hematocrit and Platelets while the laboratory tested patients specimen. 2. For 2022- Event 1, Hematology, CMS reported no scores while the laboratory tested patients specimen. 3. The Laboratory Director affirmed (6/07/22 at 6:30PM) the aforementioned findings; and thus, the failure to attain satisfactory proficiency testing scores. 4. The reliability and quality of hematology results reported could not be assured when the laboratory failed to attain overall scores of at least 80% in proficiency testing. The laboratory reported 1,250 results during six months of testing (CLIA Application, 6/02/22). Hematology test reports randomly selected from the affected timeframes in 2021 and 2022 were, as follows: Test date Time specimen was tested 1/18/21 10:09 AM 2/22 /21 8:55 AM 3/13/21 10:17 AM 4/10/21 10:00 AM 5/19/21 14:17 PM 6/04/21 8:33 AM ... 1/03/22 1:27 PM 2/07/22 8:34 AM 3/01/22 12:59 PM 4/04/22 8:26 AM 5/04 /22 9:27 AM 6/06/22 6:05 PM . . . D2123 HEMATOLOGY CFR(s): 493.851(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 observation of the Sysmex XP300 hematology analyzer, review of 2021 - 2022 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and WSLH (Wisconsin State Laboratory of Hygiene) and laboratory records; the lack of proficiency test records, and interview with the Laboratory Director (Owner), it was determined that the laboratory failed to participate in hematology proficiency testing. Findings included: 1. 2021 - Event 1, Hematology a. Laboratory records documented proficiency samples were tested on 3/10/22, after the 3/05/21 deadline for reporting results. b. As a consequence of being unable to submit results for evaluation, the laboratory failed to participate. 2. 2022- Event 1, Hematology a. The laboratory failed to provide records of proficiency testing for the first event in 2022 (March) while continuing to test patients specimen. b. CMS reported no scores, indicating the laboratory had not participated in proficiency testing. c. The Order -- 2 of 3 -- Confirmation for 2022 revealed proficiency testing in routine hematology was not ordered until 6/03/22. 3. The Laboratory Director/Owner affirmed (6/07/22 at 7: 00PM) the aforementioned findings; and thus, the failures to participate in proficiency testing for the first events of 2021 and 2022 while testing patients specimen. 4. The reliability and quality of hematology results reported could not be assured when the laboratory failed to participate in proficiency testing. The laboratory reported 1,250 results during six months of testing (CLIA Application, 6/02/22). Hematology test reports randomly selected from the timeframes of the first events in 2021 and 2022 were, as follows: Test date Time specimen was tested 1/18/21 10:09 AM 2/22/21 8:55 AM 3/13/21 10:17 AM 4/10/21 10:00 AM 5/19/21 14:17 PM 6/04/21 8:33 AM ... 1/03 /22 1:27 PM 2/07/22 8:34 AM 3/01/22 12:59 PM 4/04/22 8:26 AM 5/04/22 9:27 AM 6 /06/22 6:05 PM 5. This deficiency was previously cited on 10/06/20. . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the serious nature and cumulative effects of the deficiencies cited, the Laboratory Director (Owner) is herein cited at the Condition level for deficient practice in providing overall management of the laboratory. Findings included: 1. The Laboratory Director was deficient in his practice of directing the laboratory to report COVID test results to public health. See D1002. 2. The Laboratory Director was repeatedly deficient in his practice of directing the laboratory to test proficiency testing samples as required and report results as required for participation in proficiency testing. See D6016. 3. This deficiency was previously cited on 10/06/20. . D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the deficiencies cited at D2121 and D2123, the Laboratory Director is herein cited for deficient practice in ensuring the laboratory tested and reported proficiency testing samples as required to participate in all proficiency testing events. 1. This deficiency was previously cited on 10/06/20. . -- 3 of 3 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the random patient test result records from 2018, 209 and 2020, random comparisons of the patient samples test results from the split samples sent out to an outside CLIA certified laboratory, and lack of CMS approved proficiency testing (PT) test result reports, and interview with the laboratory director and the testing personnel, it was determined that the laboratory failed to meets the criteria in subpart I of this part and failed to participate a PT program approved by HHS for its hematology testing, CBC (complete blood cells count). The findings included: a. The laboratory performed CBC, a hematology testing by Sysmex XP-300 with serial # B0346 for the test results including WBC (white blood cell), RBC (red blood cell), Hgb (hemoglobin), Hct (hematocrit), and Platelet count, which are listed in the subpart I of 42 CFR part 493. b. The laboratory must enroll in an approved program or programs approved by CMS/HHS for which the laboratory seeks certification. c. On October 6, 2020 @ 11:05 am, the laboratory failed to present evidences of its participation of CBC testing with a PT program approved by CMS/HHS, see D-2123 D2123 HEMATOLOGY CFR(s): 493.851(c) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 review of the random patient test result records from 2018, 209 and 2020, random comparisons of the patient samples test results from the split samples sent out to an outside CLIA certified laboratory, and lack of CMS approved proficiency testing (PT) test result reports, and interview with the laboratory director and the testing personnel, it was determined that the laboratory failed to meets the criteria in subpart I of this part and failed to participate a PT program approved by HHS for its hematology testing, CBC (complete blood cells count). The findings included: a. The laboratory performed CBC, a hematology testing by Sysmex XP-300 with serial # B0346 for the test results including WBC (white blood cell), RBC (red blood cell), Hgb (hemoglobin), Hct (hematocrit), and Platelet count, which are listed in the subpart I of 42 CFR part 493. b. The laboratory failed to participate in a PT program approved by CMS/HHS from the years of 2018, 2019, and 2 parts of 2020. c. On October 6, 2020 @ 11:15 am, the laboratory failed to present records of its CBC PT result report records from 2018, 2019, and 1st and the 2nd part of PT participation. d. The laboratory director affirmed (10/06/2020 @ 11:25 am) that instead of participation of the CMS/HHS approved PT program, the laboratory had sent out split samples in 2018, 2019, and 2020 randomly to a CLIA certified laboratory for comparison of its CBC test results. e. The laboratory currently participated CBC PT program with WSLH (Wisconsin State Laboratory Hygiene) Proficiency Testing for the 3rd event. f. The laboratory performed CBC in approximately 85 patient samples each month. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's patient test result records in 2018, 209 and 2020, random reports comparisons of the test results from the split samples sent out to an outside CLIA certified laboratory, and lack of CMS approved proficiency testing (PT) test result reports, and interview with the laboratory director and the testing personnel, it was determined that the laboratory failed to meets the criteria in subpart I of this part and is approved by HHS. The laboratory director failed to be responsible for the overall operation, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. The findings included: a. The laboratory performed CBC by Sysmex XP-300 with serial # B0346 -- 2 of 3 -- for the test results including WBC (white blood cell), RBC (red blood cell), Hgb (hemoglobin), Hct (hematocrit), and Platelet count, which are listed in the subpart I of 42 CFR part 493. b. The laboratory failed to participate in a PT program approved by CMS/HHS in 2018, 2019, and part of 2020 see D-6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's patient test result records in 2018, 209 and 2020, random reports comparisons of the test results from the split samples sent out to an outside CLIA certified laboratory, and lack of CMS approved proficiency testing (PT) test result reports, and interview with the laboratory director and the testing personnel, it was determined that the laboratory failed to meets the criteria in subpart I of this part and failed to participate a PT program approved by HHS. The laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of this part. The findings included: a. The laboratory performed CBC by Sysmex XP-300 with serial # B0346 for the test results including WBC (white blood cell), RBC (red blood cell), Hgb (hemoglobin), Hct (hematocrit), and platelet count, which is listed in the subpart I of 42 CFR part 493. b. The laboratory failed to participate in a PT program approved by CMS/HHS in 2018, 2019, and parts of 2020 and failed to test as required under Subpart H of this part, see D-2123. -- 3 of 3 --