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Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1407; D6000: Laboratory Director, Moderate Complexity 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and Medical Laboratory Evaluation AAB (American Society of Bioanalysis) proficiency testing graded evaluations, the laboratory failed to 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 -- successfully participate in a proficiency testing program for two consecutive testing events in the specialty of Hematology for the analyte Hematocrit, resulting in unsuccessful performance. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and Medical Laboratory Evaluation AAB (American Society of Bioanalysis) proficiency testing graded evaluations, the laboratory failed to achieve satisfactory performance for the analyte Hematocrit for two consecutive testing events in 2024 and 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Hematocrit: (a) Third Event 2024 - 0% (b) First Event 2025 - 20% (2) A review of the proficiency testing scores from Medical Laboratory Evaluation AAB (American Society of Bioanalysis) for 2024 and 2025 confirmed the above findings. 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and Medical Laboratory Evaluation AAB (American Society of Bioanalysis) proficiency testing graded evaluations, the laboratory director failed to provide overall management and direction for two consecutive events in 2024 and 2025, resulting in unsuccessful performance. 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and Medical Laboratory Evaluation AAB (American Society of Bioanalysis) proficiency testing graded evaluations, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for the analyte Hematocrit in two consecutive testing events in 2024 and 2025. Refer to D2130. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/06/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory manager at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to ensure the room temperature, relative humidity, and refrigerator temperatures had been documented as observed during the review period of November 2024 through February 2025. Findings include: RT (ROOM TEMPERATURE) AND RH (RELATIVE HUMIDITY): (1) On 03/06/2025 at 10:30 am the laboratory manager stated the laboratory performed CBC (Complete Blood Count) using Sysmex pocH-100i test system; (2) A review of the manual titled, "Automated Hematology Analyzer pocH-100i "Instructions for use required an operating temperature range of 59 to 86 degrees F (Fahrenheit) and a maximum of 80% RH; (3) A review of the monthly "Lab Maintenance Log" from 11/01/2024 through 02/28/2025 identified RT and RH readings had not been recorded as follows: (a) Room Temperature: (i) December 2024 - three of 31 days (specific days were 12 /20,28,29/2024) (ii) January 2025 - three of 31 days (specific days were 01/01,28,29 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 -- /2025) (b) Relative Humidity: (i) November 2024 - one of 30 days (specific day was 11/28/2024) (ii) December 2024 - three of 31 days (specific days were 12/20,28,29 /2024) (iii) January 2025 - four of 31 days (specific days were 01/01,21,28,29/2025) (4) The records were reviewed with the laboratory manager who stated on 03/06/2025 at 01:00 pm, the RT and RH readings had not been documented as stated above. REFRIGERATOR TEMPERATURE: (1) Observation of the laboratory on 03/06 /2025 at 10:28 am, identified three bottles of Eightchek-3WP quality control materials (lot #42200710) stored in the refrigerator with a manufacturer's storage requirement of 2-8 degrees Centigrade (C); (2) A review of temperature logs for four months showed the temperature had not been documented as follows: (i) November 2024 - one of 30 days (specific day was 11/28/2024) (ii) December 2024 - three of 31 days (specific days were 12/20,28,29/2024) (iii) January 2025 - two of 31 days (specific days were 01/28,29/2025) (3) Interview with technical consultant 03/06/2024 at 01:30 pm confirmed the temperatures had not been documented as performed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/07/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the office manager at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure the humidity was maintained as required by the manufacturer of the Sysmex pocH-100i analyzer for was stored as required by the manufacturer for two of 14 months. Findings include: (1) On 03/07 /2023 at 10:30 am, the office manager stated the laboratory performed CBC (Complete Blood Count) testing using the Sysmex pocH-100i analyzer; (2) A review of the manual "Sysmex pocH-100i Instructions for Use" in Section 1.2.2 titled, "Performance Characteristics-Specifications" stated," Relative humidity 30-85%"; (3) A review of the laboratory humidity records from January 2022 through February 2023 identified the humidity readings were less than 30% for four of 14 months as follows: (a) January 2022 - 25 of 31 humidity readings were documented as less than 30% (days 02,03,04,06,07,10,11,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28.29,30,31); (b) February 2022 - five of 28 humidity readings was documented as less than 20% (days 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 -- 08,09,10,11,15). (4) The records were reviewed with the office manager who stated on 03/07/2023 at 11:50 am the laboratory humidity had not been maintained as required by the manufacturer as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 03/29/2021. The findings were reviewed with testing person #1 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for 3 of 3 patient specimens. Findings include: (1) On 03/29/2021 at 11:45 am, testing person #1 stated the following to the surveyor: (a) The laboratory performed COVID- 19 Testing using the following instrument (i) Abbott ID Now - qualitative detection of nucleic acid from the SARS-CoV-2 viral RNA in direct nasal swabs. (2) The surveyor reviewed the manufacturer's product insert titled, "ID NOW COVID-19 PRODUCT INSERT". Under Specimen transport and storage, the manufacturer stated, "Direct nasal, throat or nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, the nasal, throat or nasopharyngeal swab can be held in its original package (or placed in a conical tube and capped tightly) at room temperature (15-30C) for up to two (2) hours prior to testing. If a direct nasal, throat or nasopharyngeal swab specimen will be held longer than two (2) hours, it must be refrigerated at 2-8C and tested within 24 hours from the time of sample collection." (3) The surveyor reviewed 3 test reports for patients tested between 12/29/2020 and 12/31/2020. The reports did not include the following to ensure patient specimens followed manufacturer's instructions: (a) Date and time of specimen collection; (b) Date and time of specimen receipt into the laboratory; (c) 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 -- Date and time of specimen testing. (4) The reports were reviewed with testing person #1, who stated on 03/29/2021 at 03:05 pm the patient reports did not include a specimen information as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with testing person #1, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) On 03/29/2021 at 11:45 am, testing person #1 stated to the following to the surveyor: (a) CBC (Complete Blood Count) testing was performed on the Sysmex pocH-100i analyzer; (b) A replacement pocH analyzer was put into use on 06/21/2021. (2) The surveyor reviewed the manufacturer's quarterly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log titled "pocH-100i (Trademark) MAINTENANCE LOG", which was: (a) Clean Waster Chamber (3) Maintenance records were reviewed by the surveyor for 6 months (July 2020 through December 2020). The quarterly maintenance for the 3rd and 4th quarter had not been documented as performed; (4) The surveyor reviewed the records with testing person #1. The testing person stated on 03/29/2021 at 03:00 pm, there was no evidence the above maintenance had been performed as required. -- 2 of 2 --