Advanced Urgent Care Of The Middle Keys

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 04 /13/2026 for Advanced Urgent Care of the Middle Keys. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803(a)(b)(c) Condition: Successful Participation D6000 493.1403 Condition: Moderate Complexity 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email 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 -- communication with the API PT program, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte of B-Natriuretic Peptide (BNP) for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the API proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on 04/02/2026 at 11:21 AM, the laboratory had unsatisfactory testing scores for the analyte BNP for 2 out of 3 testing events in 2025 and 2026. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email communication with the API PT program, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte of B-Natriuretic Peptide (BNP), for 2 out of 3 testing events in 2025 and 2026. Findings included: Review of the laboratory's API proficiency testing (PT) records review of the Centers for Medicare & Medicaid Services (CMS) CASPER 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the subspecialty of Routine Chemistry for the analyte BNP for 2 out of 3 testing events in 2025 and 2026. 1. Event #3 2025 BNP non-waived - 60% 2. Event #1 2026 BNP non-waived - 60% 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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, the laboratory's American Proficiency Institute (API) PT records, email communication with the API PT program, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the subspecialty of Routine Chemistry for the analyte of B-Natriuretic Peptide for 2 out of 3 testing events in 2025 and 2026, resulting in initial unsuccessful PT participation (Refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 surveyor Proficiency Testing (PT) desk review, a review of the Centers for Medicare & Medicaid Services (CMS) Casper 155 and 155, the laboratory's American Proficiency Institute (API) PT records, email communication with the API PT program, the Laboratory Director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the subspecialty of Routine Chemistry for the analytes of B-natriuretic Peptide for 2 out of 3 testing events in 2025 and 2026, resulting in initial unsuccessful PT participation (Refer to D2096). -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was conducted on 01 /14/2026 for Advanced Urgent Care of the Middle Keys. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803(a)(b)(c) Condition: Successful Participation D6000 493.1403 Condition: Moderate Complexity 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 surveyor proficiency testing (PT) desk review, review of the laboratory's American Proficiency Institute (API) PT records and the review of the Centers for Medicare & Medicaid Services (CMS) Casper reports 153 and 155, and email 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 -- communication with the API PT program, the laboratory failed to successfully participate in the specialty of Routine Chemistry for the analytes of Creatine kinase isoenzyme (CK ISO) for 2 out of 3 testing events in 2024 and 2025. Findings included: Review of the API proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on 12/15/2025, the laboratory had unsatisfactory testing scores for the analyte, CK ISO for 2 out of 3 testing events in 2024 and 2025. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 review of the laboratory's proficiency testing (PT) records for 2024 and 2025, the laboratory did not have successful performance in proficiency testing for one (1) analytes in the specialty of Routine Chemistry. Findings included: Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records review of the Centers for Medicare & Medicaid Services (CMS) CASPER 153 and 155 reports, and email communication with the API PT program, the laboratory failed to successfully participate in the specialty of Routine Chemistry for the analyte, Creatine Kinase Isoenzyme (CK ISO ) 2 out of 3 testing events in 2024 and 2025. 1. Event #3 2024 CK ISO- 40% 2. Event #2 2025 CK ISO- 60% 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 surveyor Proficiency testing (PT) desk review, a review of the Center for Medicare and Medicaid Services (CMS) Casper 155 and 155, the laboratory's American Proficiency Institute (API) PT records, email communication with the API PT program, the laboratory director failed to ensure the laboratory performed PT in such a manner as to achieve and maintain satisfactory performance with successful PT in the specialty of Routine Chemistry for the analyte of Creatine kinase isoenzyme (CK ISO) 2 out of 3 testing events in 2024 and 2025 (Refer to D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor Proficiency Testing (PT) desk review, a review of the Center for -- 2 of 3 -- Medicare and Medicaid Services (CMS) 155, the laboratory's 2024 and 2025 PT records, and email communication with the API PT program, the Laboratory Director failed to ensure the laboratory maintained successful PT performance in the specialty of Routine Chemistry for the analyte of Creatine Kinase Isoenzyme (CK ISO) for 2 out of 3 testing events in 2024 and 2025, resulting in initial unsuccessful PT participation. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 06/06/2022 to 06/13/2022 found the ADVANCED URGENT CARE OF THE MIDDLE KEYS clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory quality assesment (QA) activities failed to ensure the enrollment in proficiency testing (PT) for two out of three events for Hematology specialty and one out of three events in Chemistry specialty. Findings include: -Review of PT American Proficiency Institute (API) records in 2021 (three events) revealed that the laboratory had no results in first and second events of Hematology and first event of Chemistry. -Review of the 2021 Renewal Order Form received from API revealed that the laboratory received the renewal notification on 09/08/2020. No confirmation order found for this renewal order form. -The laboratory Quality Assurance Plan defined that quarterly the laboratory will review PT performance. Review of "Proficiency Testing Review Documentation" form for November 2020, revealed that the QA failed to monitor the status of enrollment for year 2021. During an interview on 06/06/2022 at 11:45 AM, the Technical Consultant A confirmed that the laboratory QA failed to ensure that the laboratory enrolled in PT for year 2021 for the events of reference. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview with Technical Consultant (TC), the laboratory director (LD) failed to ensure that the facility enrolled in a PT program approved by the Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) for two out of three events of Hematology and one out of three events of Chemistry. Findings include: -Review of American proficiency Institute (API) PT records for 2021 revealed: no results for Hematology first and second events and No results for Chemistry first event. -The laboratory was performing the following tests: Cell Identification, Red Blood Cell Count, Hematocrit, Hemoglobin, White Blood Cell Count, and Platelets. The laboratory performed 560 tests from January to August 2021. b) No results for Chemistry first event. The laboratory was performing the following tests: B-Type Natriuretic Peptide, Creatine Kinase MB and Myogloblin. The laboratory performed 88 tests from January to May 2021. During an Interview on 06/06/2022 at 12.30 PM, the TC confirmed that the LD failed to ensure that the facility enrolled in a PT program for Hematology and Chemistry in 2021 for the events of reference. -- 2 of 2 --