Clermont Urgent Care

Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 21, 2021. Clermont Urgent Care clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to comply with Federal and State regulations in the disposal of the Corona Virus Disease 2019 (COVID-19) test vials for the Quidel QuickVue SARS Antigen Test. Findings: On 09 /21/2021 at 11:14 AM and 11:36 AM, Testing Personnel B was observed throwing away COVID-19 test vials in the regular trash can lined with a clear plastic trash bag. Review of the package insert from the Quidel QuickVue SARS Antigen Test noted "Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements." The laboratory had also used CareStart Rapid COVID-19 Antigen Test, the Veritor Rapid SARS-CoV-2 Test, and the Visby Medical Rapid Covid Point of Care. Review of the package inserts for the other three tests used by the laboratory noted to dispose of contents as biohazardous waste. The Occupational Safety and Health Administration (OSHA) regulation 1910.1030(b) defined regulated waste as a "liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials." OSHA regulation 1910.1030(d)(4)(iii)(B)(1) - (d)(4)(iii)(B)(1)(iii) read, "Regulated 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 -- waste shall be placed in containers which are: Closable; Constructed to contain all contents and prevent leakage of fluids during handling, storage, transport or shipping; Labeled or color-coded in accordance with paragraph (g)(1)(i) this standard; and Closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping." OSHA regulation 1910.1030(g)(1)(i)(A) read, "Warning labels shall be affixed to containers of regulated waste, refrigerators and freezers containing blood or other potentially infectious material." OSHA regulation 1910.1030(g)(1)(i)(C) - (g)(1)(i)(E) noted, "These labels shall be fluorescent orange or orange-red or predominantly so, with lettering and symbols in a contrasting color. Labels shall be affixed as close as feasible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. Red bags or red containers may be substituted for labels." The Florida Department of Health's Best Practice for COVID-19 Disposal letter dated May 5, 2020, posted on the Florida Department of Health's website, noted "COVID-19 is a Category B infectious substance, and is not required to be handled differently than any other regulated medical waste per the Occupational Safety and Health Administration, and the Centers for Disease Control and Prevention." Florida Statute Chapter 381.0098 read, "Biomedical waste means any solid or liquid waste which may present a threat of infection to humans." Florida regulations 64E-16.004 2C, showed " Biomedical waste, except sharps, shall be packaged and sealed at the point of origin in impermeable, red plastic bags or, at the discretion of the generator, into sharps containers." On 09/21 /2021 at 11:36 AM, Testing Personnel B stated they were told to throw the vials in the regular trash can. On 09/21/2021 at 12:55 PM, the Laboratory Directory stated the trash in the can that Testing Personnel B put the COVID-19 test vials in, was thrown out with regular trash. On 09/21/2021 at 3:15 PM, the Laboratory Director stated they started COVID-19 testing on 11/20/20 and performed 623 tests in 2020 and 3200 test in 2021. D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to ensure confidentiality of patient information by discarding labeled specimen test vials in the regular trash can. Findings: On 09/21/2021 at 11:14 AM and 11:36 AM, Testing Personnel B was observed throwing away Corona Virus Disease 2019 (COVID-19) test vials which contained patient label in the regular trash can lined with clear plastic trash bag. Review of patient's label showed the patient's name, date of birth, date of the test, account number, and home phone number. On 09/21/2021 at 11:36 AM, Testing Personnel B stated they were told to throw the vials in the regular trash can. On 09/21/2021 at 12:55 PM, the Laboratory Directory stated the trash can that Testing Personnel B put the labeled vials in, was thrown out with the regular garbage. On 09 /21/2021 at 3:15 PM, the Laboratory Directory stated they started COVID-19 testing on 11/20/20 and performed 623 tests in 2020 and 3200 test in 2021. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the -- 2 of 3 -- 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) 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 record review and interview, the laboratory failed to follow the manufacturer's instructions by not performing calibrations on the Sysmex XP-300 hematology analyzer every six months from 08/03/2019 to 08/25/2020. Findings: Review of the manufacturer's operations manual on the Sysmex XP-300 noted, "Calibration is required minimally every six months." Review of the quality control documents for the Sysmex XP-300 showed documentation of a calibration between 08 /03/2019 to 08/25/2020 was missing. During an interview on 09/20/2021 at 12:53 PM, the Laboratory Director stated the calibration due in February 2020 was not done. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on August 29, 2019. Clermont Urgent Care clinical laboratory was found not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 observation, interview and record review, the laboratory failed to retain instrument printouts from the Sysmex XP-300 hematology analyzer for at least two years. Findings: Review of the Sysmex XP-300 hematology analyzer's instrument printouts of the daily quality control records showed that the first date of testing was 5 /4/18. Observation of documents stored in the hematology analyzer's memory showed that patient test results were not saved for 2018 and that the patient test results for 2019 were available for only recent patients. During an interview on 8/29/19 at 11:56 AM, the Laboratory Director stated the patient test result printouts were discarded after the results were entered into the computer. During an interview on 8/29/19 at 11: 59 AM, the Laboratory Director stated she did not know how long patient test results were maintained in the analyzer's memory. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H 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 2 -- This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to document the review and evaluation of proficiency testing for 2018, (events A, B, and C), and 2019 (events A, and B). Findings: Review of the American Academy of Family Physicians (AAFP) proficiency testing documentation showed that the Laboratory Director had not signed and dated the results forms for 2018 events A, and 2019 events A, and B. The laboratory also failed to have the documentation of the results for 2018 events B and C until the Laboratory Director printed the results from AAFP's website. The procedure titled "Proficiency Testing" signed by the Laboratory Directory on 3/4/19 stated "Proficiency testing results will be reviewed within 30 days of receipt of results." During an interview on 8/29/19 at 9:40 AM, the Laboratory Director acknowledged that the forms were not signed and dated, and she did not know where the results for events B and C for 2018 were located. 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)