Atlantis Urgent Care

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Atlantis Urgent Care from June 11, 2025 to June 30, 2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2000 493.801 - Enrollment and Testing of Samples D5200 493.1230 - General Laboratory Systems D6000 493.1403 - Moderate Complexity Laboratory Director 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 procedure manual and American Proficiency Institute (API) proficiency testing records, and interview, the Laboratory Director and Testing Personnel failed to sign the attestation form for proficiency testing (PT) for five (2025 1st, 2024 1st, 2nd, 3rd, & 2023 3rd events) of seven PT events (2025 1st, 2024 1st, 2nd, 3rd, & 2023 1st, 2nd, 3rd events) for the specialty of hematology. (See D2009) D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of procedure manual and American Proficiency Institute (API) proficiency testing (PT) records, and interview, the Laboratory Director and Testing Personnel failed to sign the attestation form for PT for five (2025 1st, 2024 1st, 2nd, 3rd, & 2023 3rd events) of seven PT events (2025 1st, 2024 1st, 2nd, 3rd, & 2023 1st, 2nd, 3rd events) for the specialty of hematology. This is a repeat deficiency from 02 /06/2023 and 03/05/2021 recertification surveys. Findings: 1. Review of the procedure titled, Proficiency Testing read, "The Laboratory Director and all staff performing the testing should sign in the attestation spaces provided on the date sheet." 2. Review of the API Attestation Statement noted, "Signatures Required - For all PT results, an attestation statement must be signed by testing personnel and laboratory director and retained for a minimum of 2 years." 3. Review of the API PT records showed attestation statements for 2025 1st, 2024 1st, 2nd, and 3rd, events were not signed by the Laboratory Director or Testing Personnel. The attestation for 2023 3rd event was missing. 4. During an interview on 06/10/2023 at 10:27 AM, Technical Consultant A acknowledged attestations were not signed by the Laboratory Director or Testing Personnel. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the procedure manual and American Proficiency Institute (API) proficiency testing (PT) records, and interview, the Laboratory Director and the Technical Consultants failed to document review and evaluation of proficiency testing (PT) results for three (2024 1st, 2023 1st, 3rd) of seven (2025 1st, 2024 1st, 2nd, 3rd, & 2023 1st, 2nd, 3rd events) for the specialty of hematology. See D5211. 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. This STANDARD is not met as evidenced by: Based on review of procedure manual and American Proficiency Institute (API) proficiency testing (PT) records, and interview, the Laboratory Director and Technical Consultants failed to document the review and evaluation of proficiency testing (PT) results for three (2024 1st, 2023 1st, 3rd) of seven (2025 1st, 2024 1st, 2nd, 3rd, & 2023 1st, 2nd, 3rd events) for the specialty of hematology. This is a repeat deficiency from the 02/06/2023 recertification survey. Findings: 1. Review of the procedure -- 2 of 6 -- titled, Proficiency Testing, section Assessment of the Proficiency Testing Report read, "Proficiency testing results will be reviewed within 30 days of receipts of results. The procedure also noted, "Initially, both the testing personnel and the Laboratory Supervisor should review the PT scores, and if all are satisfactory, the forms are signed and dated. 2. Review of the Job Description for the Laboratory Directed included, "Ensuring that the laboratory's proficiency testing performance is evaluated and necessary

Summary Statement of Deficiencies D0000 A recertification survey was conducted on February 6, 2023. Atlantis Urgent Care clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review, and interview, the Laboratory Director and the Testing Personnel failed to sign the attestation form for proficiency testing (PT) for one (2022 1st event) of six PT events (2021 1st, 2nd, 3rd & 2022 1st, 2nd, 3rd events) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) Attestation Statement noted "Signatures Required - For all PT results, an attestation statement must be signed by testing personnel and laboratory director and retained for a minimum of 2 years." Review of the API PT records showed the attestation statement was not signed by the Laboratory Director or the testing personnel. On 02/06/2023 at 10:55 AM, the Technical Consultant acknowledged the attestation was not signed by the Laboratory Director or the testing personnel. 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 (PT) results for two (2021 3rd event, 2022 1st event) of six (2021 1st, 2nd, 3rd & 2022 1st, 2nd, 3rd events) PT events for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) PT showed the Laboratory Director failed to sign the "Proficiency Testing Performance Evaluation" forms for the 2021 3rd event and the 2022 1st event. On 02 /06/2023 at 10:55 AM, the Technical Consultant acknowledged the performance reviews were not signed by the Laboratory Director. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on January 17, 2023 for Atlantis Urgent Care. Atlantis Urgent Care is not in compliance with the 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 2022, the laboratory did not have successful performance in proficiency testing for analytes in the specialty of hematology. Refer to D2130. 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 January 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 -- 17, 2023 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, electronic white blood cell differential for two out of three testing events in 2022. 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 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 for analytes in the specialty of hematology. Findings include: On January 17, 2023 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, electronic white blood cell differential, as shown below. Event #2, 2022 electronic white blood cell differential- 28% Event #3, 2022 electronic white blood cell differential-28% 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 in proficiency testing for analytes found in the specialty of hematology. Findings include: On January 17, 2023, 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, electronic white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. 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 analyte(s) found in the specialty of hematology. 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 January 17, 2023, on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events for the analytes shown below. Event #2, 2022 electronic white blood cell differential-28% Event #3, 2022 electronic white blood cell differential-28% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification survey was conducted on March 2, 2021. Atlantis Urgent Care clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 record review and interview, the Laboratory Director and Testing Personnel failed to have documentation of the signed attestation form for proficiency testing (PT) for 1 (2020 1st event) of 6 (2019 1st, 2nd, 3rd & 2020 1st, 2nd, 3rd events) for the specialty of hematology. Findings: Review of the American Proficiency Institute (API) Attestation Statement noted "Signatures Required - Testing personnel and laboratory director must physically sign an attestation statement for PT results, and retain the signed statement (or a copy) for a minimum of 2 years." Review of the API PT records showed that the signing the attestation statement for the 1st event in 2020 was missing. During an interview on 03/02/2021 at 10:50 AM, Testing Personnel B stated he was unable to locate the attestation forms for the 2020 1st event. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper 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 -- use. This STANDARD is not met as evidenced by: Based on observation, record review, and interview, the laboratory failed to label the quality control vials currently in use with the open date and expiration date. Findings: Examination of the XN-L hematology controls for the Sysmex XN-L analyzer on 03 /02/2021 at 10:25 AM showed the quality control vials for level 1, 2 and 3 did not have the open date and the new expiration date for the vials currently being used. Review of the package insert for the controls noted "Open vials and vials which have been sampled by cap piercing will retain stability for 15 days if stored at 2 - 8 degrees C after being re-capped." During an interview on 03/02/2021 at 10:30 AM, Testing Personnel B stated the open date and the new expiration date were not on the control vials. -- 2 of 2 --