Bsa Physicians Group,Inc Dba Bsa Urgent Care Cente

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and interview showed that the laboratory failed to self-grade results not scored by the PT agency in two of two events reviewed in 2023 and 2024. Findings follow. A. Review of the College of American Pathologists (CAP) Evaluation results for Clinical Microscopy (CM) PT records in the A 2023 and the B 2024 testing events showed the laboratory failed to self-grade results. The Evaluation for CM-A 2023 event, for sample USP-02 showed for Urine Sediment a Result of "See Note [27]". The Evaluation for CM-B 2024 event, for sample CMP-14 showed for Urine Sediment a Result of "See Note [27]". Review of the Participant Summary under "Actions Laboratories Should Take when a PT Result is Not Graded" stated for Code 27 Exception Reason Code Description: "Lack of participant or referee consensus." And, under Action Required stated, "Document that the laboratory performed a self-evaluation and compared its results to the intended response when provided in the participant summary. If comparison is not available, perform and document alternative assessment (ie, split samples) for the period that commercial PT reached non-consensus to the same level and extent that would have been tested." Documentation of self-evaluation was requested on March 18, 2025 at 1100 hours but not provided. B. Interview with the Technical Consultant 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 -- (as listed on the CMS Form 209) on March 18, 2025, at 1100 hours in the office confirmed the findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records, and interview, the laboratory failed to verify the accuracy of urine sediment microscopy, potassium hydroxide (KOH), and wet preps at least twice annually for one of four events reviewed in 2023 and 2024. Findings follow. A. Review of the College of American Pathologists (CAP) PT records from 2023 and 2024 showed one accuracy assessment in 2024 for urine sediment microscopy, KOH, and wet preps. Additional accuracy assessments were requested on March 18, 2025 at 1140 hours but not provided. B. Interview with the Technical Consultant (as listed on the CMS Form 209) on March 18, 2025 at 1140 hours confirmed they enrolled late in 2024 and missed an event. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 the College of American Pathologists (CAP) proficiency testing records from 2021 and 2022, policies and procedures and staff interview, the laboratory failed to review and evaluate proficiency testing results for four of five events for hematology , and four of four events for Clinical Microscopy . This is a repeat deficiency from the September 2021 inspection. The findings included: 1. Review of CAP proficiency testing records from 2021 and 2022 (3 testing events annually) found no documentation of review for the following testing events: FH2- C 2021 Hematology Auto Differentials, FH2 FH2-A 2022 Hematology Auto Differentials, FH2 FH2-B 2022 Hematology Auto Differentials, FH2 FH2-C 2022 Hematology Auto Differentials, FH2 CM-A 2021 Clinical Microscopy CM-B 2021 Clinical Microscopy CM-A 2022 Clinical Microscopy CM-B 2022 Clinical Microscopy 2. Review of the laboratory's written procedure titled External Proficiency Testing found on page two "I. The review form and Survey together with any documentation is rerouted to the Medical Director for final Review and filing." 3. Testing person one on the CMS report 209 Laboratory Personnel Report confirmed in the interview conducted November 1, 2022 at 2:08 PM that the laboratory did not route the proficiency testing documents to the laboratory director for review as defined in their own written procedure. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) 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 -- The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of proficiency testing records from 2021 and 2022 and interview of facility personnel, the laboratory failed to evaluate the results that included exception codes in four of four testing events for Clinical Microscopy. The findings included: 1. Review of the College of American Pathologists (CAP) Clinical Microscopy proficiency records from 2021 and 2022 found the following events with analytes not evaluated or scored by the proficiency testing program without documented review by the laboratory: a. CM-A 2021 Clinical Microscopy: Exception code [11] = Unable to analyze (documentation to be provided by laboratory) Exception code [28] = Response qualified with a greater than or less than sign; unable to quantitate b. CM-B 2021 Clinical Microscopy: Exception code [28] = Response qualified with a greater than or less than sign; unable to quantitate c. CM-A 2022 Clinical Microscopy: Exception code [11] = Unable to analyze (documentation to be provided by laboratory) Exception code [27] = Lack of participant or referee consensus Exception code [28] = Response qualified with a greater than or less than sign; unable to quantitate d. CM-A 2022 Clinical Microscopy: Exception code [11] = Unable to analyze (documentation to be provided by laboratory) Exception code [27] = Lack of participant or referee consensus Exception code [28] = Response qualified with a greater than or less than sign; unable to quantitate 2. Review of the CAP instructions found on page 98 under the heading Actions Laboratories Should Take when a PT Result is not Graded " The CAP uses exception reason codes that signify the proficiency testing (PT) for an analyte has not been graded. The exception reason code is located on the evaluation report in brackets to the right of the result. Your laboratory must identify all analytes with an exception code, review, and document the acceptability of performance as outlined below and retain documentation of review for at least 2 years. The actions laboratories should take include, but are not limited to: a. Code 11 - Document why the specimens were not analyzed (eg, instrument not functioning or reagents not available). Perform and document alternative assessment (ie, split samples) for the period that commercial PT was not tested to the same level and extent that would have been tested. b. Code 27 - Document that the laboratory performed a self evaluation and compared its results to the intended response when provided in the participant summary. If comparison is not available, perform and document alternative assessment (ie, split samples) for the period that commercial PT reached non-consesus to the same level and extent that would have been tested. c. Code 28 - Applies to a response that is not formally evaluated when a less than or greater than sign is reported. Document that the laboratory performed a self-evaluation and compared its results to the proper statistics applied in the participant summary. Verify detection limits. Perform and document the

Summary Statement of Deficiencies 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: Review of manufacturer's instructions, patient final reports and interview of facility personnel found the laboratory failed to follow the manufacturer's instructions when using the Sofia SARS Antigen and the Sofia Flu+SARS Antigen test kits for testing 16348 patients tested between August 1, 2020 andOctober 6, 2021. The findings included: 1. Review of the manufacturer's instructions found on page 19 under the heading CONDITIONS OF AUTHORIZATION FOR LABORATORY " Authorized laboratories using the Sofia SARS Antigen FIA and the Flu+SARS Antigen FIA must include with the test result reports, all authorized Fact Sheets." 2. Review of patient results found no fact sheets included with the final report for three of three patient reports reviewed. 3. Interview of the Technical Consultant conducted September 21, 2021 at 10:32 AM confirmed that the Fact Sheets were not included with the patient test results for SARS COV-2 testing. 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: 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 -- Based on review of the College of American Pathologists (CAP) proficiency testing records from 2020 and 2021, policies and procedures and staff interview, the laboratory failed to review and evaluate proficiency testing results for one of five events for hematology , and one of three events for clinical Microscopy . The findings included: 1. Review of CAP proficiency testing records from 2020 and 2021 (3 testing events annually) found no documentation of review for: the FH2-B 2021 Hematology Auto Differentials testing event. the CM-A 2021 Clinical Microscopy Event. 2. Review of the laboratory's written procedure titled External Proficiency Testing found on page two "I. The review form and Survey together with any documentation is rerouted to the Medical Director for final Review and filing." 3. Interview of the Technical Consultant conducted on September 21, 2021 at 2:25 PM confirmed that proficiency testing records for these events was not documented. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, reagent IFUs from manufacturer, the laboratory's records from 2018-2021, and confirmed in an interview, the laboratory failed to document quality control testing after change in reagents on the Beckman Coulter AcT Diff 2 hematology analyzer for CBC testing. The findings were: 1. Review of the policy titled "CBC AcT Diff 2 (Effective date: 4/14/2009; Review /Revised: 9/28/2015)" revealed the laboratory having three reagents for the Beckman Coulter AcT Diff 2 hematology analyzer (SN#AT44535) for CBC testing. diff AcT Pak reagent diff AcT Tainer reagent AcT Rinse Shutdown Diluent 2. Review of Coulter diff AcT Pak reagent kit (Ref: 8547134; 772249-AE) IFU revealed under Storage, Stability, and Disposal, "If the operating environment of your laboratory is 16-25C, discard opened container after 60 days. If the operating environment of your laboratory is 26-35C, discard opened container after 30 days." 3. Review of Coulter diff AcT Tainer reagent kit (Ref: 8547135; 772247-AF) IFU revealed under Storage, Stability, and Disposal, "Opened containers are stable for 30 days when used at 16- 25C." 4. Review of Coulter AcT Rinse Shutdown Diluent (Ref: 8547113; 772252-AF) IFU revealed under Storage, Stability, and Disposal, "Open containers are stable for 30 days when used at 16-35C." 5. Review of the laboratory records from 2018-2021 revealed no documentation of reagent changes on the Beckman Coulter AcT Diff 2 hematology analyzer for CBC testing. 6. Review of the CMS 116 signed by the LD on 9/20/21 revealed the CBC testing annual volume for hematology was 5952. 7. An interview with the technical consultant on 9/21/21 at 12:11 PM in the Lab confirmed quality control testing was not performed after change of reagents on the Beckman Coulter AcT Diff 2 hematology analyzer. Key: IFU=Instruction for use CBC=Complete Blood Count LD=Laboratory Director D6061 CLINICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1419(c) -- 2 of 3 -- The clinical consultant must ensure that reports of test results include pertinent information required for specific patient interpretation. This STANDARD is not met as evidenced by: Based on the review of the laboratory's policy, and confirmed in an interview the Clinical consultant failed to ensure the reference range necessary for interpretations was included in patient final reports for one of 16 analytes (RDW) for CBC testing. The findings were: 1. Review of the CBC AcT Diff 2 Policy (Effective date: 4/14 /2009, Reviewed/Revised: 9/25/2015) revealed the reference range for RDW was, Male Results 11.5%-14.5% Female Results 11.5%-14.5% Child Results 12.7%-15.0% 2. One example of patient final reports reviewed revealed no reference range included for interpretation for RDW result. 9/16/21 Patient ID: 945265 3. An interview with the technical consultant on 9/21/21 at 12:18 PM in the office confirmed the RDW reference range was not included on the patient final reports. Key: CBC=Complete Blood Count RDW=Red cell distribution width -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.801 Condition: enrollment and testing samples 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: Review of proficiency testing records and interview of facility personnel found that the laboratory failed to enroll in a proficiency testing program in a timely matter in order to participate in the first testing event of 2018 (three events per year) for the specialty of hematology. The findings included: 1. Review of the College of American pathologists (CAP) proficiency testing records from 2017 third testing event through 2019 first testing event found that the laboratory failed to participate in the first testing event of 2018 for hematology. 2. Interview of the technical consultant conducted on May 14, 2019 at 9:01 AM confirmed that the laboratory failed to enroll in a proficiency testing program in a timely matter in order to participate in the first testing event of 2018. D2010 TESTING OF PROFICIENCY TESTING SAMPLES 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 -- CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records, instrument test records, review of policies and procedures and interview with facility personnel, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. The findings included: 1. A review of the College of American Pathologists (CAP) proficiency testing records from 2017, 2018 and 2019 (three events per year) revealed five of five hematology proficiency samples from the first testing event of 2019 were each tested twice. 2. Review of the facility procedure titled External Proficiency Testing found under the heading Procedure: " The survey material will be analyzed as if it were a patient and, when possible, shall enter the patient workload as if it were a patient" 3. Interview of the Technical Consultant conducted on May 14, 2019 at 9:19 AM confirmed that the proficiency testing samples were tested twice, but testing personnel only tested patient specimens once. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records for 2017 third testing event through 2019 first testing event and staff interview, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program for one of five testing events resulting in unsatisfactory performance for all analytes in the specialty of hematology. The findings include: 1. Review of the College of American Pathologists (CAP) proficiency testing records for 2018 third testing event through 2019 first testing event (three testing events per year) found that the laboratory failed to submit proficiency results for the 2018 third testing event to the proficiency testing agency for scoring prior to the cut off date. Failure to submit results to the proficiency testing agency resulted in a score of 0% for all analytes. 2. Interview of the technical consultant conducted on May 14, 2019 at 9:12 AM confirmed that proficiency testing results for the hematology 2018 third testing event were not submitted in a timely manner to be evaluated by the proficiency testing agency resulting in a score of 0% for all analytes. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or -- 2 of 4 -- baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, centrifuge maintenance function checks, and confirmed in interview, the laboratory failed to define a function check protocol that ensures the accuracy of revolutions per minute (RPM) and the timer on the Drucker Diagnostics Model 642 centrifuge used to prepare urine specimens for urine sediment testing. The findings included: 1. Review of the Drucker Diagnostics Model 642 centrifuge operator's manual, under the heading of "Performance/Calibration", states: "Maximum speed depends on the incoming line voltage and the load being spun. a line voltage of 115 volts is required to achieve the speeds described in this manual. If the unit is running 10 percent slower than specified, it should be returned to your dealer or the Drucker Company for repair." 2. The laboratory's policy titled "Urinalysis - Microscopic Exam" under the section Procedure (Step-by-Step Instructions), states: " Spin for 5 minutes at 1800 rpm." 3. The laboratory's model 642 centrifuge was last checked by the biomedical department on December 3, 2018. The speed at the time of the inspection was noted as 3,210 RPM. 4. Interview of the biomed specialist conducted on May 15, 2019 at 11:12 AM confirmed that the laboratory did not have a policy to assess the centrifuge at the appropriate level for it preparing urine sediment. She. She continued that she only evaluated the centrifuge at the highest speed. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Review of the laboratory's own Quality Assessment procedure, and interview of facility personnel found that the laboratory failed to follow it's own procedure for monthly quality assessment review. The findings included: 1. Review of the policy titled Quality Assurance found : "A Comprehensive quality assurance manual will be developed to contain all the quality assurance policies and procedures of the laboratory, evaluations of the effectiveness of these policies and procedures, and identification of