Utica Park Clinic - Owasso

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/19/2025. The laboratory was found in compliance with standard-level deficiencies cited. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant, the laboratory failed to label two of two bins of BD butterfly blood collection devices with the expiration date, and lot number of the contents. Findings include: (1) On 11/19/2025 at 11:35 am, observation of the laboratory identified two unlabeled bins containing the following items; (a) Approximately 50 BD 23 gauge butterfly blood collection devices that had been removed from their primary packaging and placed into the bin; (b) Approximately 50 BD 21 gauge butterfly blood collection devices that had been removed from their primary packaging and placed into the bin. (3) Interview with the technical consultant on 11/19/2025 at 11:35 am, confirmed that the packaging had been discarded and they had no way to track the lot numbers or expiration dates of the butterfly collection devices; (4) The findings were reviewed with the technical consultant on 11/19/2025 at 11:35 am who stated the bins had not been labeled with the contents, expiration date, and lot numbers. D5807 TEST REPORT CFR(s): 493.1291(d) 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 -- (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population for two of two patient reports reviewed. Findings include: (1) On 11/19/2025 at 1:00 pm, the technical consultant stated the laboratory performed CBC (Complete Blood Count) testing using the Medonic M-series hematology analyzer; (2) Review of two patient CBC reports (the first report was for an adult female patient with the testing performed on 11/18/2025 at 01:55 pm and the second report was for an adult male patient with the testing performed on 03/17/2025 at 01:10 pm) identified both reports included the same reference intervals for the following CBC parameters: (a) WBC (White Blood Cell) count - 3.5-10.0 (10^3/mL); (b) RBC (Red Blood Cell) count - 3.5-5.5 (10^6/mL); (c) Hemoglobin - 11.5-16.5 g /dL; (d) Hematocrit - 35.0-55.0 %; (e) Platelets - 100-400 (10^3/mL). (3) The reports were reviewed with the technical supervisor who stated on 11/19/2025 at 01:00 pm, the patient reports did not include gender specific reference ranges for WBC, RBC, Hemoglobin, Hematocrit, and Platelets. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (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 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 11/19/2025, a review of personnel records for one of one person performing moderate complexity testing identified the following: (a) Testing Person #3 - The initial training was completed on 08/22/2024 and the first competency evaluation was completed on 03/18/2025. The second competency evaluation was not performed until 11/17/2025; (2) Interview with the technical consultant on 11/19/2025 at 12:30 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 02/06/2024 The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 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 a review of records, policies and procedures, and interview with the technical consultant, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for one of two annual function checks performed during the review period of January 2022 through the current date. Finding include: (1) On 02/06/2024 at 2:00 pm, the technical consultant stated the following: (a) Urine sediment examinations were performed by the laboratory; (b) The specimens were processed a Unico centrifuge at a speed of 2000 rpm (revolutions per minute) +/- 250 RPM for 5 minutes; (2) A review of the procedure titled, " Laboratory centrifuge maintenance", stated "Centrifuge RPM verification shall be performed and recorded at least once per year. RPM for urine centrifuges must be 2000+/- 250" for five minutes +/- 30 seconds"; (3) A review of centrifuge function check records during 2022 through the current date identified on 12/5/2023 the centrifuge speed timer had been checked at eight minutes, rather than five minutes; (5) The records 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 -- were reviewed with the technical consultant, who stated on 02/06/2024 at 2:00 pm, the laboratory had not followed their policy. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/11/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 the technical consultant, the technical consultant failed to ensure evaluations included complete documentation of all moderate complexity testing performed for one of two persons. Findings include: (1) On 01/11/2022 at 10:45 am, the technical consultant stated to the surveyor the following testing were performed in the laboratory: (a) CBC (Complete Blood Count) using the Medonic M-Series analyzer (b) Urine Microscopic (c) Wet Prep Analysis (2) The surveyor then reviewed personnel records for 2 persons (testing person #1 and testing person #3) hired to perform the above testing after the previous recertification survey performed 09/19/2019 with the following identified for one of two persons: (a) Testing Person #1 - Semi-annual competency dated as 09/22/2021 (i) Although the semi-annual competency form had been signed and dated by the technical consultant on 09/22/2021, there was no documentation to prove the evaluation included an assessment of the testing listed above (this portion of the form was blank). (3) The surveyor reviewed the findings with the technical consultant who stated on 01/11 /2022 at 12:36 pm that, although the assessment included all areas of testing, the form had been completed on the computer and the entries had not been saved. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES 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 -- 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the technical consultant failed to ensure evaluations included complete documentation of all moderate complexity testing performed for two of two persons. Findings include: (1) On 01/11/2022 at 10:45 am, the technical consultant stated to the surveyor the following testing were performed in the laboratory: (a) CBC (Complete Blood Count) using the Medonic M-Series analyzer (b) Urine Microscopic (c) Wet Prep Analysis (2) The surveyor then reviewed personnel records for 2 persons (testing person #2 and testing person #3) requiring annual competencies for the above testing, with the following identified for two of two persons: (a) Testing Person #2 - Annual competency dated as 07/22/2021 (i) Although the annual competency form had been signed and dated by the technical consultant on 07/22/2021, there was no documentation to prove the evaluation included an assessment of the testing listed above (this portion of the form was blank). (b) Testing Person #3 - Annual competency dated as 07/22/2021 (i) Although the annual competency form had been signed and dated by the technical consultant on 07/22/2021, there was no documentation to prove the evaluation included an assessment of the testing listed above (this portion of the form was blank). (3) The surveyor reviewed the findings with the technical consultant who stated on 01/11/2022 at 12:36 pm that, although the assessments included all areas of testing, the forms had been completed on the computer and the entries had not been saved. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on 09/19/19. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with the technical consultant, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) During the survey, the surveyor reviewed 2018 and 2019 Hematology proficiency testing records. The following failure was identified, for which

Summary Statement of Deficiencies No Tags No deficiency details available. 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 No Tags No deficiency details available. 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 findings were reviewed with the technical consultant at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director and analyst. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified for 1 of 24 proficiency testing events: (a) 2016 Immunology 3rd Event - The attestation statement had not been signed and dated by the laboratory director and analyst. (2) The surveyors reviewed the records with the technical consultant, who stated the attestation statement, as indicated above, had not been signed and dated by the laboratory director and the analyst. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to maintain records of lot numbers and expiration dates of media used for patient testing. Findings include: (1) At the beginning of the survey, the technical consultant stated that the laboratory performed throat culture testing (reported as presumptive for Streptococcus A) using SSA (Strep Select Agar) plates and Bacitracin discs; (2) Surveyor #2 then reviewed quality control records for testing performed from January through December 2017. There was no documentation in the records which included the lot numbers and expiration dates of media used during the review period; (3) The technical consultant stated that the laboratory did not have a method in place to maintain records of lot numbers of media used in the laboratory. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the technical consultant, written policies and procedures had not been approved by the current laboratory director. Findings include: (1) At the beginning of the survey, the technical consultant stated to surveyors the following testing was performed: (a) CBC (Complete Blood Count) testing using the Boule Medonic M Series analyzer (2) The technical consultant stated to the surveyors the instrument was put into use for patient testing on 07/05/17; (3) Surveyor #2 reviewed the procedure manual for the above testing. It had not been approved, signed, and dated by the current laboratory director; (4) The surveyors then reviewed the procedure manual with the technical consultant, who stated it had not been approved, signed, and dated by the current laboratory director. 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 and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyors: (a) CBC (Complete Blood Count) testing was performed using the Medonic M-Series analyzer; (b) The analyzer was put into use on 07/05/17 to replace the Beckman Coulter AcT Diff 2 analyzer. (2) Later -- 2 of 3 -- during the survey, surveyor #1 reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. The requirements for maintenance were as follows: (a) Daily Cleaning (b) Monthly Cleaning (3) Surveyor #1 then reviewed maintenance records for 6 months (July 2017 through December 2017). It was identified for 4 of 6 months, that maintenance procedures had been documented on Beckman Coulter AcT Diff 2 analyzer logs. The AcT Diff 2 analyzer had different maintenance requirements, therefore, surveyor #1 could not determine if the required maintenance had been performed on the Medonic M-Series analyzer as follows: (a) Daily Cleaning (i) July - Days 05,06,07,10,11,12,13,14,17,18,19,20,21,24,25,26,27,28,31 (ii) August - Days 01,02,03,04,07,08,09,10,11,14,15,16,17,18,21,22,23,24,25,28,29,30,31 (iii) September - Days 01,05,06,07,08,11,12,13,14,15,18,19,20,21,22,25,26,27,28,29 (iv) October - Days 02,03,04,05,06,09,10,11,12,13,16,17,18,19,20,23,24,25,26,27,30,31 (b) Monthly - Not performed 4 of 6 months (July, August, September, October) (4) Surveyor #1 reviewed the records with the technical consultant who stated the incorrect maintenance logs had been used, and there was no documentation to prove the maintenance procedures had been performed for the 4 months. -- 3 of 3 --