Advanced Urgent Care Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Advanced Urgent Care Center from March 13, 2025 to March 24, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain copies of the instrument test results for Chemistry proficiency event #3 for the year 2023, one out of six events reviewed 2023 (events #1, #2 and #3) and 2024 (events #1, #2 and #3). Findings included: 1-Review of the American Proficiency Institute (API) test records showed that on 9/11/2023 the laboratory did not maintain a copy of the instruments test results from the Triage-Alere analyzer for the 3rd event in 2023. 2- Review of the laboratory Proficiency Testing procedure manual revealed in step "11. All instrument tapes, worksheets, attestation and the reviewed survey results will be kept readily available for two years." Additional instructions stated in bold print "NOTE: The following data must be retained for two years: ...The instrument tapes /printout..." 3- Interview on 03/13/2025 at approximately 12:05 PM, the laboratory Technical Consultant confirmed that the laboratory did not keep the records of Triage- Alere analyzer for this event. 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 D0000 A recertification survey conducted on 05/18/2021 found that the ADVANCED URGENT CARE CENTER clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with technical consultant (TC) B, the laboratory failed to perform calibration verification procedures of the Medonic M Series 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 -- Analyzer at least every 6 months from 4/3/2019 to 10/23/2020. Findings include: - Review of the Medonic M Series Analyzer calibration records revealed that the laboratory performed calibrations on 4/3/2019, 1/24/20 and 10/23/20. During an interview on 05/18/2021 at 2:00 p.m., TC B confirmed that the laboratory failed to perform instrument calibration every 6 months in the period of 4/3/2019 to 10/23 /2020. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 08 /27/2020 for Advanced Urgent Care Center (lab name) is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 20129 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on August 27, 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 -- 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, blood urea nitrogen (BUN) for two out of three testing events in 2019 and 2020. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the sub specialty of routine chemistry. Findings include: On August 27, 2020 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, blood urea nitrogen, as shown below. Event #3, 2019 blood urea nitrogen-60% Event #2, 2020 blood urea nitrogen-40% 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 review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On August 27, 2020, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, blood urea nitrogen, in the subspecialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analyte, blood urea nitrogen in the subspecialty of routine chemistry. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on August 27, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2019 blood urea nitrogen-60% Event #2, 2020 blood urea nitrogen-40% -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of CMS 209-Laboratory Personnel Report, review of American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) A, the laboratory failed to have all testing staff rotate through the testing of PT for 1 out of 2 years reviewed (2017-2018). Findings include: -Review of the CMS 209 (signed and dated by the Laboratory Director 1/16/2018 had 6 testing TP listed (A, B, C, D, E, F). -Review of API PT records found that TP F did not performed any PT during 2018. -Interview 01/16/2019 at approximately 3:00 pm, TP A confirmed that TP F did not performed PT during 2018 even though TP F performed patient testing. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation and interview with Testing Person (TP) A the laboratory failed to adequate set up the laboratory and phlebotomy in a separate space in order that one activity does not interfere with the other. Findings include: Observation of the laboratory revealed that: - There is not enough space for the the phlebotomy area, that 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 -- it is located inside the laboratory in the back of a narrow hallway. Next to the drawing chair there is a cable station that it is not properly secured which represents a potential hazard for patients and staff. -The sink with the eyewash for the laboratory and drawing station, has a printer placed just in front of it, there is a potential risk for electrical accident. During an interview on 01/16/2019 at 3:30 PM, the TP A confirmed that the location of the drawing station is not adequate. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview with Testing Person (TP) A, the laboratory failed to have atestation signed by TP B in 2 out of 6 events and for TP B in 1 out of 6 events reviewed for Hematology and Chemistry for 2 years reviewed (2017-2018). Findings include: Review of API PT reports for 2017 and 2018, revealed that : -The laboratory failed to have attestation signed by TP D for 1st event Hematology/Coagulation 2017. - The laboratory failed to have attestation signed by TP B for 2nd Event of Chemistry and Hematology for 2018. During an interview on 01/16/2019 at 2:30 PM, the TP A confirmed that the laboratory failed to have the signed attestation by TP A and D for the events of reference. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on EasyRA quality control (QC) policy, QC record review and interview with Testing Person #A (TPA) the laboratory failed to have the 2 levels controls within acceptable range for Triglycerides (TRIG), Alanine Aminotransferase (ALT), Albumin (ALB), Aspartate Transaminase (AST), Blood Urea Nitrogen (BUN), Calcium (Ca), Alkaline Phosphatase (ALK), prior to testing patients on 1 testing date 11/15/2018. Findings included: Review of QC policy stated that for EasyRA no patient tested until two control levels are accepted. Review of QC records for EasyRA revealed that on 11/15/18 of the 2 levels controls (A, B), control A was run twice, in the 1st run was in the range, another run performed 9 minutes later the control was out of acceptable range for TRIG, ALT, ALB, AST, BUN, CA, ALK. No records of any further run for control A available. Patients tested on the day of reference. There were no records explaining why the TP ran the controls twice, and why patients tested when the control was out of range. On the day of reference, patient 1 and 2 tested and reported using EasyRA. During an interview, on 01/16/19 at 2:30 PM with the TPA, she confirmed that there were no records of a rerun for the controls out of range for analytes mentioned above, nor documentation of the review. -- 2 of 2 --