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Summary Statement of Deficiencies 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 the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to attest to the routine integration of PT samples into the patient workload for six of seven PT events testing in the subspecialty of routine chemistry in the years of 2023,2024, and 2025. Findings include: 1. Review of laboratory policies and procedures revealed the policy titled, "Proficiency Testing Program", which indicated, in the section labeled "II. Policy", that "11. Attestation statement is signed by the laboratory director or qualified designee and all individuals involved in the testing process." 2. Review of AAB-MLE PT records found attestation statements lacked signatures for testing in routine chemistry for six of seven events reviewed in the years of 2023, 2024 and 2025. Event: Year: 2 2023 3 2023 1 2024 3 2024 1 2025 2 2025 3. Interview with the LD on 06/12/2025, at 10:20 pm, confirmed the laboratory failed to attest to the routine integration of PT samples into the patient workload for six of seven PT events reviewed for routine chemistry testing in the years of 2023, 2024, and 2025. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time 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 -- of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of laboratory records, patient test reports, and interview with the laboratory director (LD), the laboratory failed to maintain records that included the identity of the personnel who performed patient specimen testing for three of six patient testing dates reviewed in the subspeciality of routine chemistry. Findings include: 1. Review of laboratory records and patient test reports revealed the laboratory failed to identify who performed patient testing on three of six testing dates reviewed. Date: Patient Account #: 10/31/2023 208941 11/17/2023 220936 01/01 /2025 226242 2. Interview with the LD on 06/12/2025, at 10:20 am, confirmed the laboratory failed to maintain records that included the identity of the personnel who performed patient specimen testing. -- 2 of 2 --

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 record review and interview, the laboratory failed to ensure five of six testing personnel (TP) who routinely perform Chemistry testing participate in proficiency testing (PT) events during the years of 2021 through 2022. Findings include: 1. The laboratory procedures manual, Laboratory Personnel Report (CMS209), patients' test logs, and American Associates of Bioanalysts (AAB) PT documents for the years of 2021 through 2022 were reviewed. 2. The laboratory's PT policy and procedures and AAB-PT program instructions revealed the requirement for TP who routinely perform patient testing to participate in PT sample testing. 3. The laboratory participated in 6 PT events during the years of 2021 through 2022. The PT documents revealed 6 of 6 PT events were performed by TP2. 4. CMS-209 and test logs showed 6 TP were performing routine Chemistry testing. 5. The laboratory director confirmed the above findings on July 1, 2022 at 11:10 AM. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when 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 -- they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform control procedures using the number and frequency established by the laboratory for Brain natriuretic peptide (BNP) testing for five of fourteen months, affecting 21 patients' tests. Findings Include: 1. The laboratory's policies and procedures manual, quality control (QC) logs from the month of May 2021 through May of 2022, Individual quality control plan (IQCP) and patients' electronic medical records (EMR) were reviewed. 2. The laboratory's IQCP for BNP testing revealed the following requirement: *Perform liquid QC testing every 30 days and with each new lot. 3. The QC records showed the laboratory failed to perform QC procedures during the months of July, August, September and November of 2021, and April of 2022. 4. 21 patients were tested during the period QC procedures were not performed. 5. The laboratory director confirmed the above findings on July 1, 2022 at 11:10 AM. -- 2 of 2 --

Summary Statement of Deficiencies 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 CASPER Report 0155D Proficiency Testing (PT) records and communication with the American Association of Bioanalysts (AAB) PT program representative; the laboratory failed to successfully participate in the testing of PT samples for the specialty of hematology and the analytes: Cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 2 of 2020 and event 1 of 2021. Findings include: 1. Review of CASPER Report 0155D (generated on 5-03-2021) and communication with the (AAB) PT provider on 05/06/2021 at 8:37 AM, confirmed the initial unsuccessful performance for the specialty hematology analytes cell identification/white blood cell 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 -- differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 2 of 2020 and event 1 of 2021. See D2130. 2. Review of CASPER Report 0155D (generated on 5-03-2021) and communication with the (AAB) PT provider on 05/06/2021 at 8:37 AM, confirmed the initial unsuccessful performance for the specialty of hematology for event 2 of 2020 and event 1 of 2021. See D2131. 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 review of the CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the hematology analytes cell identification/white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 2 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the initial unsuccessful performance for the hematology analytes identified below. HEMATOLOGY Cell Identification/White Blood Cell Differential - EVENT 2, 2020 0% Unsatisfactory Cell Identification/White Blood Cell Differential- EVENT 1, 2021 0% Unsatisfactory Red Blood Cells- EVENT 2, 2020 0% Unsatisfactory Red Blood Cells- EVENT 1, 2021 0% Unsatisfactory Hematocrit - EVENT 2, 2020 0% Unsatisfactory Hematocrit- EVENT 1, 2021 0% Unsatisfactory Hemoglobin - EVENT 2, 2020 0% Unsatisfactory Hemoglobin- EVENT 1, 2021 0% Unsatisfactory White Blood Cells- EVENT 2, 2020 0% Unsatisfactory White Blood Cells- EVENT 1, 2021 0% Unsatisfactory Platelets- EVENT 2, 2020 0% Unsatisfactory Platelets- EVENT 1, 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05/06/2021 at 8:37 AM, confirmed the unsatisfactory scores for the hematology analytes cell identification /white blood cell differential, red blood cells, hematocrit, hemoglobin, white blood cells, and platelets for event 2 of 2020 and event 1 of 2021. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for 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 CASPER Report 0155D Proficiency Testing (PT) records and communication with the PT provider American Association of Bioanalysts (AAB) program representative; the laboratory failed to successfully participate in the testing of the specialty hematology for event 2 of 2020 and event 1 of 2021. Findings include: 1. Review of the CASPER Report 0155D, generated on 05-03-2021, revealed the initial unsuccessful performance for the specialty of hematology. HEMATOLOGY - EVENT 2, 2020 0% Unsatisfactory HEMATOLOGY - EVENT 1, -- 2 of 3 -- 2021 0% Unsatisfactory 2. A phone interview with the (AAB) PT representative on 05 /06/2021 at 8:37 AM, confirmed the unsuccessful performance for the specialty of hematology for event 2 of 2020 and event 1 of 2021. -- 3 of 3 --

Summary Statement of Deficiencies D5016 ROUTINE CHEMISTRY CFR(s): 493.1210 If the laboratory provides services in the subspecialty of Routine Chemistry, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1267, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on direct observation, review of laboratory records and interview with the laboratory director (LD); the laboratory failed to meet chemistry testing requirements specified in 493.1230 through 493.1256, 493.1267, and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to perform control procedures as specified by the laboratory's individual quality control plan (IQCP) for chemistry testing on Alere Triage meters for 4 of 6 patient test dates reviewed. See D5445. 2. The laboratory failed to have a system in place that twice yearly evaluates the relationship between the analytes creatinine kinase MB (CK-MB) and troponin I (TNI) tested on two Alere Triage Meters. See D5775. 3. The laboratory failed to immediately alert an individual or entity requesting a test result when panic values were identified for troponin I (TNI) testing. See D5813. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- (LD); the laboratory failed to meet the requirements for hematology testing specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299. Findings Include: 1. The laboratory failed to include two control materials of different concentrations for complete blood count (CBC) testing on the Beckman Coulter Act diff 2 analyzer each day of patient testing. See D5447. 2. The laboratory failed to have a system in place that twice yearly evaluates the relationship between d-dimer testing on two Alere Triage Meters. See D5775. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to perform control procedures as specified by the laboratory's individual quality control plan (IQCP) for chemistry testing on Alere Triage meters for 4 of 6 patient test dates reviewed. Findings include: 1. Direct observation of the laboratory equipment on 10-08-2019 at 12:05pm identified two Alere Triage meters used for troponin I (TNI) and creatinine kinase MB (CK-MB) testing, serial numbers 0068964WW and 00079814WW. 2. Review of the IQCP for troponin I (TNI)/Creatinine kinase MB (CK-MB)) testing on Alere Triage meters revealed that external controls will be tested with each new lot or shipment of test material or every 30 days. 3. Review of patient tests results troponin I and CK-MB for 4 of 6 patient testing dates reviewed revealed external quality controls (QC) were not performed each month on the analyzer used for testing as described in the IQCP. Patient Identification Test Date Analyte Analyzer ID External QC Date T1 02-14- 2019 Troponin I, CK-MB 8964 11-16-2018 T2 09-13-2019 Troponin I, CK-MB 9814 08-12-2019 T5 04-10-2019 Troponin I, CK-MB 8964 11-16-2018 T6 06-17-2019 Troponin I, CK-MB 9814 02-21-2019 4. Review of external quality control testing for TNI/CK-MB revealed that external quality control testing was not performed on analyzer 9814 for 10 of 19 months reviewed in 2018 through 2019. 5. Review of external quality control testing for TNI/CK-MB revealed that external quality control testing was not performed on analyzer 8964 for 11 of 19 months reviewed in 2018 through 2019. 6. No external quality control were performed every 30 for TNI/CK- MB testing for the following months on either analyzer: September 2019, May 2019, April 2019, March 2019, January 2019, September 2018, August 2018, and June 2018. 7. Review of test volume records from September of 2018 through September of 2019 revealed 316 combined tests were performed for TNI and CM-MB. 8. On survey date 10-08-2019, at 7:15 pm, the LD confirmed that external quality controls were not performed as described for both Alere Triage meters for TNI/CK-MB testing. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) -- 2 of 10 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory records, and interview with the lab director (LD); the laboratory failed to ensure two levels of quality control (QC) materials were ran each day of testing before reporting complete blood count (CBC) patient test results for 1 of 5 patient testing dates reviewed. Findings include: 1. Direct observation of laboratory equipment on 10-08-2019 at 12:05pm identified a Beckman Coulter AcT diff 2 hematology analyzer used for CBC testing, serial number 44554083. 2. Review of patient test reports for CBC testing found no documented quality control records for 1 of 5 patient testing dates reviewed. Patient Identification Test Date C4 09-13-2019 3. Review of patient testing records revealed 3 patients in total had CBC testing performed on 9-13-2019. 4. On survey date 10-08-2019, at 7:15 pm, the LD confirmed that two levels of quality control material were not performed 9-13-2019. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on direct observation, review of the laboratory records, and interview with the laboratory director (LD); the laboratory failed to have a system in place that twice yearly evaluates the relationship between the analytes d-dimer, creatinine kinase MB (CK-MB), and troponin I (TNI) tested on two Alere Triage Meters. Findings Include: 1. Direct observation on 10-08-2019, at 12:06 pm, identified two Alere Triage Meters (Serial Numbers: 0068964WW and 00079814WW). 2. Review of laboratory records revealed the laboratory failed to evaluate the relationship between the two Alere Triage meters used for D-Dimer, CK-MB, and TNI testing in 2018 and 2019. 3. On survey date 10-08-2019, at 7:15 PM, the LD confirmed the laboratory failed to evaluate the relationship between the two Triage Meter twice yearly for D-Dimer, CK- MB, and TNI. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. -- 3 of 10 -- This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to immediately alert an individual or entity requesting a test result when panic values were identified for troponin I (TNI) testing. Findings Include: 1. Review of the laboratory's policy and procedure manual identified panic value documentation for TNI as greater or equal to 01.ng/dL. Additionally the laboratory had a log used to document panic values identified by the laboratory and the notification to the individual or entity requesting the test result. 2. Review of patient testing for TNI identified a patient (Identifier - T7) who had a panic value TNI of 10.3 ng/dL on 02-07-2019. 3. Review of the panic value log revealed the laboratory failed to document the panic value for TNI on 2-07-2019 for patient T7 and document the panic value was reported to the individual or entity that requested the test. 4. Further review of TNI patient testing in 2018 through 2019 identified two additional patients with panic value results for TNI testing. Patient Identification Date TNI Value T8 12-05-2018 5.63 ng/dL T9 07-19-2019 0.16 ng/dL 5. Review of the panic value log revealed the laboratory failed to document the two additional panic values identified for patient's T8 and T9. 6. The last documented panic value in the log was recorded on 09-08-2018. 7. On survey date 10-08-2019, at 7:15 PM, the LD confirmed the laboratory failed to document 3 of 3 TNI panic values and ensure they were immediately alerted to the individual or entity that requested the test. 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 review of laboratory records and interview with the laboratory director (LD); the facility failed to have a laboratory director (LD) who meets the qualifications requirements of 493.1405 and provide overall management and direction in accordance with 493.1407 of this subpart. Findings Include: 1. The laboratory failed to have a qualified laboratory director who meets the experience requirements to direct a laboratory. See D6003. 2. The LD failed to ensure an approved

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory records and interviews with testing personnel (TP) #10 and TP#14; the laboratory failed to establish policies and procedures to assess employee competency. Findings Include: 1. Review of the laboratory's policy and procedure manual found no policy had been established to assess the competency of personnel listed on the CMS-209. 2. On survey date 02-06-2018 at 04:25 pm, TP#10 and TP#14 confirmed the laboratory failed to establish a competency assessment policy. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory records and interviews with testing personnel (TP) #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 4 -- and TP#14; the laboratory failed to monitor refrigerator/freezer temperatures to ensure accurate and reliable storage of hematology and chemistry reagents in 2017 through the date of survey (02-06-2018). Findings Include: 1. Review of the laboratory log, "Daily Refrigerator/Freezer Temperature Log", states "1. Temperatures of the fridge and the Freezer should be documented daily". 2. Review of the laboratory's temperature logs from November 20, 2017 through the date of survey, February 6, 2018 identified multiple dates when daily temperatures of the Frigidaire, Serial #BA2022411, refrigerator/freezer were not documented on the "Daily Refrigerator /Freezer Temperature log". Dates when no refrigerator/freezer temperatures were documented December 8, 2017 through January 18, 2018 January 25, 2018 January 28, 2018 3. On survey date 02-06-2018, at 4:24 pm, TP#10 and TP#14 confirmed the laboratory failed to document the temperature of the refrigerator/freezer used to store chemistry and hematology reagents daily for 2 of 4 months reviewed. D5781