Broken Arrow Family Clinic

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/17/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and testing person #1 at the conclusion of the survey. 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 review of records and interview with the technical consultant, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for three of five proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 09/17/2025, a review of 2024 and 2025 proficiency testing events identified attestation statements had been signed after the graded evaluation was completed by the proficiency testing program for three of five events reviewed: (a) Third Hematology/Coagulation Event 2024 - The graded evaluation was completed on 12/11/2024 and the attestation statement had not been signed by the laboratory director until 12/11/2024; (b) First Hematology/Coagulation Event 2025 - The graded evaluation was completed on 04/16/2025 and the attestation statement had not been signed by the laboratory director until 04/16/2025; (c) Second Hematology /Coagulation 2025 - The graded evaluation was completed on 08/18/2025 and the attestation statement had not been signed by the laboratory director until 08/18/2025; (2) The records were reviewed with the technical consultant who stated on 09/17/2025 at 01:10 pm the attestation statements had not been signed timely as stated above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1 and a phone call communication with the technical consultant, the laboratory failed to ensure competency evaluations for moderate complexity testing had been performed at least two times (semiannually) during the first year of testing for one of one testing person. Findings include: (1) On 09/17/2025, a review of personnel records for one person performing moderate complexity testing identified the following: (a) Testing Person #2 - The initial training was completed on 08/23/2024 and the first competency evaluation was completed on 03/06/2025. There was no evidence a second competency evaluation had been performed to date; (2) Interview with testing person #1 on 09/17/2025 at 12:50 pm and a phone call communication with the technical consultant following the survey on 09/22/2025 at 01:05 pm confirmed that the second competency evaluation had not been completed during the first year of patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/06/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant, testing person #1, and testing person #2 at the conclusion of the survey. 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, manufacturer's instructions, observation, and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's instructions for room temperature storage for two of two reagent cartridges for Hemoglobin A1c testing. Findings include: (1) On 12/06/2023 at 10:32 am, the laboratory supervisor stated Hemoglobin A1c testing was performed using the Alere Affinion analyzer; (2) Observation of the laboratory on 12/06/2023 at 10:35 am identified two Affinion Hemoglobin A1c reagent cartridges, lot #10222982 stored at room temperature which had not been dated; (3) Review of the manufacturer's package insert under the heading "Cartridge Storage" stated, "Recommended storage is refrigerated at 2-8 C for maximum reagent life. Alternately, the cartridges can remain at room temperature (15-25 C) provided the expiration date on the carton is changed to 90 days from the date the carton is removed from the refrigerator"; (4) The findings were discussed with testing person #2 who stated on 12/06/2023 at 10:35 am, the cartridges were being stored at room temperature and had not been dated with the 90 day room temperature expiration date. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 observation and interview with the laboratory manager, the laboratory failed to ensure two of two types of blood collection tubes were stored as required by the manufacturer, in a room denoted as exam room one. Findings include: (1) Observation of the exam room and interview with testing person #1 on 12/06/2023 at 10:05 am, identified the following: (a) 300 BD Vacutainer EDTA tubes, lot # 3257721, storage temperature of 4-25 degrees Celsius; (b) 300 BD Vacutainer SST tubes, lot # 3244717, storage temperature of 4-25 degrees Celsius. (2) Interview with testing person #1 on 10/25/2023 at 10:05 am confirmed the laboratory was not monitoring the temperature of exam room one. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process; and failed to have control procedures that would detect immediate errors that would occur due to test system failure, adverse environmental conditions, and operator performance for eight of eight months reviewed for testing performed using the Sysmex XN 330 Hematology analyzer. Findings include: LEVEY-JENNINGS (1) On 12/06/2023 at 11:05 am, testing person #1 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN 330 analyzer; (b) Three levels of QC (quality control) materials were tested each day of patient testing. (2) A review of records from January 2023 through August 2023 identified no evidence, such as Levey-Jennings graphs and cumulative statistical data, to prove that QC results had been monitored for variances (i.e., biases, shifts, and trends); (3) Interview with testing person #1 on 12/06/2023 at 11:15 am confirmed that QC data to include Levey-Jennings graphs and cumulative statistical data had not been printed and reviewed during the review period. QUALITY -- 2 of 3 -- CONTROL RANGES (1) On 12/06/2023 at 11:05 am, testing person #1 stated the following: (a) The laboratory performed CBC (Complete Blood Count) testing using the Sysmex XN 330 analyzer; (b) Three levels of QC (quality control) materials were tested each day of patient testing. (2) A review of records from January 2023 through August 2023 identified no evidence, that lower limits of acceptability for QC had been entered into the analyzer for three of three lot numbers as follows; (a) QC Level I - lot# 32101401 (i) White blood cells (WBC) 0.00 - 4.96 with a mean of 2.48 (ii) Red blood cells (RBC) 0.00 - 4.68, with a mean of 2.34 (iii) Hemoglobin (HGB) 0.0 - 12.4 with a mean of 6.2 (iv) Hematocrit (HCT) 0.0 - 35.4, with a mean of 17.7 (v) Platelets (PLT) 0 - 130, with a mean of 65 (b) QC Level 2 - lot# 32101402 (i) WBC 0.00 - 13.68 with a mean of 6.84 (ii) RBC 0.00 - 8.82, with a mean of 4.41 (iii) HGB 0.0 - 25.8 with a mean of 12.9 (iv) HCT 0.0 - 72.6, with a mean of 36.3 (v) PLT 0 - 498, with a mean of 249 (c) QC Level # 3 - lot# 32101403 (i) WBC 0.00 - 32.80 with a mean of 16.40 (ii) RBC 0.00 - 10.72, with a mean of 5.36 (iii) HGB 0.0 - 33.8 with a mean of 16.9 (iv) HCT 0.0 - 93.8, with a mean of 46.9 (v) PLT 0 - 1190, with a mean of 595 (3) Interview with testing person #1 on 12/06/2023 at 11:15 am confirmed that lower limits of acceptability for quality control had not been entered into the analyzer. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/08/2021. 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. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the laboratory failed to follow calibrations procedures for one of five calibrations. Findings include: (1) On 10/08/2021 at 10:30 am, testing person #2 stated the following to surveyor #1: (a) Routine CBC (Complete Blood Count) was performed on the Beckman Coulter AcT 2 analyzer. (2) On 10/08/2021, surveyor #2 reviewed the laboratory's written procedure manual titled, "Laboratory Procedure Manual" under the section titled, "CALIBRATION" stated: (a) "All analyzers will be calibrated, or the calibration verified according to the following schedule:" (i) "At least once every six months". (3) Surveyor #2 reviewed calibration records between 03/09/2019 through 05/18/2021 and identified the following: (a) Calibration had not been performed between 12/30 /2019 and 10/16/2020. (4) Surveyor #2 reviewed the findings with testing person #1. Testing person #1 stated on 10/08/2021 at 12:10 pm, the calibration procedure had not been followed as indicated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 09/17/19. The findings were reviewed with the laboratory director and 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, manufacturer's instructions, and interview with testing person #1, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: (1) During the survey, the surveyor observed the laboratory and identified the following waived testing kits and materials with the manufacturers' storage requirement: (a) Influenza A & B testing using the BD Veritor reader and test kit - The manufacturer required a storage temperature between 59 and 86 F (Fahrenheit); (b) Strep A screen testing using the OSOM Strep kit - The manufacturer required a storage temperature between 59 and 86 F; (c) Urine pregnancy testing using the Consult Diagnostics HCG test kit - The manufacturer required a storage temperature between 59 and 86 F; (d) Macroscopic urinalysis testing using the Clinitek Status+ dipstick reader - The manufacturer required a storage temperature between 64 and 86 F; (e) Hemoglobin A1C testing using the Alere Afinion - The manufacturer required a storage temperature between 59 and 89 F. (2) The surveyor then reviewed laboratory temperature records from 2018 and 2019. The laboratory's acceptable temperature range was 39.2-71.0 degrees F which allowed the laboratory temperature to be colder than the manufacturers' required storage and testing temperature; (3) The surveyor reviewed the manufacturers' temperature requirements with testing person #1 and explained the only requirement for performing waived 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 -- testing is to follow the manufacturer's instructions, including those for temperature; (4) Testing person #1 stated to the surveyor the laboratory failed to ensure the manufacturers' temperature requirements for the testing listed above had been met. D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records, and interview with testing person #1, the laboratory failed to retain records of test requisitions and test authorizations for at least 2 years. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed patient CBC (Complete Blood Count) testing (e.g., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, automated WBC differential in numbers and percentages (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Platelet Count, etc.) using the Beckman Coulter AcT diff 2 hematology analyzer; (2) During the survey, the surveyor identified 2 patient CBC reports which had not been submitted to a reference laboratory as instructed by the laboratory's policy and procedure for flagged CBC results. The surveyor reviewed the findings with testing person #1 who stated to the surveyor the 2 CBC's might have been fingerstick samples and the sample quantity was not enough to be retested. Testing person #1 also stated to the surveyor the test requisitions would indicate if the CBC's were performed on fingerstick samples; (3) Testing person #1 could not locate the test requisitions for the two patients and stated to the surveyor an office employee destroyed the test requisitions. The surveyor explained to testing person #1 all patient test requisitions and authorizations must be retained for at least 2 years after the date of service. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records, and interview with testing person #1, the laboratory failed to retain proficiency testing records for at least 2 years. Findings include: (1) At the beginning of the survey, the surveyor reviewed Hematology proficiency testing records from 2018 and 2019. For 5 of the 5 events reviewed, there were no instrument printouts from the proficiency sample testing for the First, Second, and Third events of 2018; and the First and Second events of 2019; (2) The surveyor asked testing person #1 for the analyzer printouts from the proficiency testing performed for the events listed above. Testing person #1 stated to the surveyor the analyzer printouts from proficiency testing were not retained; (3) The surveyor explained to testing person #1 that all proficiency testing records were to be retained for at least 2 years. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 4 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, policy and procedure, and interview with testing person #1, the laboratory failed to follow its policy and procedure for patient testing. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed patient CBC (Complete Blood Count) testing (e.g., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, automated WBC differential in number and percentages (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Platelet Count, etc.) using the Beckman Coulter AcT diff 2 hematology analyzer; (2) The surveyor reviewed the laboratory's policy and procedure for flagged CBC testing results. The policy stated "patient specimens requiring further testing will be sent to the reference laboratory. Refer to page 167 of the Operator's Manual section 6.10 What Flags and Codes Mean which describes the flags and suggests actions you should perform when they appear. When indicated by instrument flag send all manual differentials to CLIA certified reference laboratory;" (3) The surveyor then reviewed 17 CBC results that obtained flags from June 2018, May 2019, and August 2019. For 2 of the 17 flagged CBC's, there was no documentation the samples had been submitted to a reference laboratory for further testing as instructed in the policy and procedure: (a) Patient #1-Testing performed 06/05/18: Obtained * flags on differential results; (b) Patient #2-Testing performed 06/11/18: Obtained * flags on Platelet count and M flags on Monocytes, number and percentages and Granulocytes, number and percentages. (4) The surveyor asked testing person #1 if the patient CBC's listed above had been submitted to a reference laboratory for further testing. Testing person #1 stated to the surveyor the laboratory failed to follow the policy and procedure and the samples had not been submitted to a reference laboratory for further testing. 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 testing person #1, the laboratory failed to ensure the manufacturer's environmental specifications had been met. Findings include: (1) At the beginning of the survey, testing person #1 stated to the surveyor the laboratory performed patient CBC (Complete Blood Count) testing (e.g., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) using the Beckman Coulter AcT diff 2 hematology analyzer; (2) The surveyor reviewed the manufacturer's temperature requirement for the analyzer. The manufacturer required the analyzer be stored and -- 3 of 4 -- operated at a temperature between 61.0 and 95.0 degrees F (Fahrenheit); (3) The surveyor then reviewed laboratory temperature records from January 2018 through the survey. The laboratory's acceptable temperature range was 39.2 to 77.0 degrees F which allowed the laboratory temperature to be colder than the manufacturer's required storage and testing temperature; (4) The surveyor reviewed the findings with testing person #1. Testing person #1 stated to the surveyor the laboratory failed to ensure the manufacturer's temperature requirement for the Beckman Coulter AcT diff 2 hematology analyzer had been met. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with testing person #1, the technical consultant failed to ensure a person was evaluated at least semiannually during the first year of performing moderate complexity testing. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records and identified the following for testing person #2: (a) This person was rehired on 04/12/18; (b) There was no evidence that a semiannual evaluation had been performed. (2) The surveyor reviewed the findings with testing person #1 who stated to the surveyor a semiannual evaluation had not been performed after testing person #2 had been rehired. -- 4 of 4 --

Summary Statement of Deficiencies D0000 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --