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Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) 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 review of SARS-COV-2 patient test records, interview with the office manager, review of public health SARS-COV-2 data reporting records and interview with the technical consultant, the laboratory failed to report SARS-COV-2 results from November 6, 2020 until July 27, 2021. The findings include: 1. Review of SARS-COV-2 patient test records revealed the laboratory began patient testing for SARS-COV-2 on November 6, 2020. 2. Interview with the office manager on November 2, 2021 at approximately 3pm revealed the laboratory did not report negative patient SARS-COV-2 test result to public health authorities from the time the laboratory began testing on November 6, 2020 until "around the first of August 2021." 3. Review of public health SARS-COV2 data reporting records revealed the first date negative results were reported to public health authorities was July 27, 2021. 4. Review of randomly selected SARS-COV-2 patient testing dates revealed the following dates when proof of public health reporting for SARS-COV-2 results could not be provided (three of four selected dates): November 12, 2020-One negative result not reported. March 5, 2021 - Eight negative results not reported. August 4, 2021 -five positive, seventeen negative results not reported. 4. Phone interview on December 10, 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 -- 2021 at approximately 3pm with the technical consultant confirmed the laboratory did not report SARS-COV-2 negative results from November 6, 2020 until approximately July 27, 2021. No documentation could be provided for reporting of either positive or negative results for August 4, 2021. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory records, laboratory procedure manual and staff interview, the laboratory failed to test proficiency testing samples the same number of times it would a patient sample in 2019, 2020 and 2021 (five of thirty proficiency testing samples). The findings include: 1. Review of proficiency testing records revealed proficiency testing samples were performed in duplicate for the following: 2019 event three--Sample number HSY-11 2020 event two--Sample number HSY-10 2020 event three--Sample number HSY-13 2021 event one--Sample number HSY-04 2021 event two--Sample number HSY-06 No flags were present on any of the samples that were repeated. 2. Review of the laboratory's procedure titled "PATIENT CBC ANALYSIS-MEDONIC-M SERIES" revealed that patient samples are repeated if flags are present. 3. Interview with the technical consultant on 11/02/2021 at approximately 3pm confirmed the laboratory did not test proficiency testing samples in the same manner as patient samples in 2019, 2020 and 2021. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory records and staff interview, testing personnel failed to sign attestation statements for two of seven proficiency testing events. The findings include: 1. Review of the laboratory's proficiency testing records revealed the following attestation statements were not signed by testing personnel: 2019 event two and 2019 event three. 2. Interview with technical consultant on 11/02/2021 at approximately 3pm confirmed testing personnel failed to sign attestation statements for two of seven proficiency testing events. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing attestation statements and interview with the technical consultant, the testing personnel failed to sign the proficiency testing attestation statements for 2016 event three, 2017 event two, and 2017 event three. The findings include: 1. Review of the laboratory's proficiency testing attestation statements for 2016 event three and 2017 events two and three revealed no testing personnel signatures. 2. Interview with the technical consultant on October 8, 2018 at 10:00 am confirmed the testing personnel did not sign the proficiency testing attestation statements for 2016 event three, 2017 event two, and 2017 event three. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of