Pediatric Specialists Of Tulsa

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/21/2025. The laboratory was found out of compliance with the following CLIA Condition: 493.1421; D6063: Laboratories performing moderate complexity testing; testing personnel The findings were reviewed with the office manager and testing person #1 during an exit conference performed at the conclusion of the survey. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (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 office manager and testing person #1, the laboratory failed to ensure written policies and procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) On 05/21/2025 at 09:00 am, the office manager and testing person #1 stated the laboratory performed CBC (Complete Blood Count) testing using the Beckman Coulter DXH 520; (2) A review of the manual titled, "CLIA Compliance Manual DxH 520 Analyzer Policies and Procedures" identified no evidence the manual had been signed and dated as approved by the laboratory director; (3) The findings were reviewed with the office manager and testing person #1. Both stated on 05/21/2025 at 01:55 pm, the manual contained the policies and procedures and had not been signed and dated by the laboratory director. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 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 -- 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on a review of records and interview with the office manager, the laboratory failed to ensure individuals who performed moderate complexity testing met the educational qualifications for one of three persons listed on the Form CMS-209. Findings include: (1) The laboratory failed to ensure a testing person met the educational qualifications. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager, the laboratory failed to ensure a testing person met the educational qualifications to perform moderate complexity testing for one of three testing persons listed on the Form CMS- 209. Findings include: (1) On 05/21/2025 at 09:00 am, the office manager and testing person #1 stated the laboratory performed CBC (Complete Blood Count) testing using the Beckman Coulter DXH 520 analyzer; (2) A review of personnel records for testing person #3 revealed no evidence of an education document to ensure the individual met the moderate complexity personnel requirements; (3) The findings were reviewed with the office manager who stated on 05/21/2025 at 11:00 am, the education document was not available. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/06/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the office manager, testing person #1, and testing person #2 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 office manager, the laboratory failed to ensure an attestation statement had been signed by the laboratory director or designee for 1 of 6 events. Findings include: (1) The surveyor reviewed 2019 (second and third events), 2020 (first, second, and third events) and 2021 (first event) Hematology proficiency testing records with the following identified: (a) Third 2020 Hematology Event - The attestation statement had not been signed by the laboratory director or designee. (2) The surveyor reviewed the records with the office manager, who stated on 07/06/2021 at 1:05 pm, the attestation statement had not been signed by the laboratory director or designee. 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 -- 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 office manager and testing person #1, the laboratory failed to ensure written policies and procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) On 07/06/2021 at 10:30 am, testing person #1 stated to the surveyor the Beckman Coulter DxH analyzer was put into use to perform patient CBC (Complete Blood Count) testing on 04/24/2020; (2) The survey reviewed the manual titled, "CLIA Compliance Manual DxH Analyzer Policies and Procedures", which contained written policies and procedures. There was no indication the manual had been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the office manager and testing person #1. Both stated on 07/06/2021 at 01:30 pm, the manual contained the policies and procedures and had not been signed and dated by the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Recertification survey was performed on 06/19/19. The findings were reviewed with the laboratory director, office manager/testing person #3, testing person #1 and testing person #2 during an exit conference performed 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 office manager/testing person #3 and testing person #2, the laboratory failed to ensure the manufacturer's instructions were followed for waived testing. Findings include: (1) At the beginning of the survey, testing person #2 stated the laboratory performed Mononucleosis testing using the Henry Schein One Step+ test kit; (2) The surveyor reviewed the package insert for the test kit, which stated "This assay has not been established for patients under 18 years of age. A heterophile antibody response is observed in approximately 80-90% of adults and children with EBV-caused IM"; (3) The surveyor requested testing records for Mononucleosis testing from August 2017 through May 2019. The office manager obtained records for 27 patients that had Mononucleosis testing performed using the Henry Schein One Step+ test kit. It was determined that for 27 of 27 patients, all were less than 18 years old. The testing for 29 patients occurred as follows: (a) Patient #1 (age 13) - testing performed on 08/11 /2017 (b) Patient #2 (age 5) - testing performed on 11/27/17 (c) Patient #3 (age 8) - testing performed on 12/19/17 (d) Patient #4 (age 15) - testing performed on 01/09/18 (e) Patient #5 (age 6) - testing performed on 01/19/18 (f) Patient #6 (age 9) - testing performed on 02/09/18 (g) Patient #7 (age 12) - testing performed on 02/09/18 (h) 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 -- Patient #8 (age 11) - testing performed on 03/08/18 (i) Patient #9 (age 8) - testing performed on 03/13/18 (j) Patient #10 (age 6) - testing performed on 07/17/18 (k) Patient #11 (age 8) - testing performed on 08/03/18 (l) Patient #12 (age 15) - testing performed on 08/21/18 (m) Patient #13 (age 14) - testing performed on 09/10/18 (n) Patient #14 (age 14) - testing performed on 09/14/18 (o) Patient #15 (age 12) - testing performed on 09/20/18 (p) Patient #16 (age 12) - testing performed on 11/14/18 (q) Patient #17 (age 15) - testing performed on 11/14/18 (r) Patient #18 (age 16) - testing performed on 12/04/18 (s) Patient #19 (age 15) - testing performed on 12/21/18 (t) Patient #20 (age 7) - testing performed on 12/27/18 (u) Patient #21 (age 16) - testing performed on 01/10/19 (v) Patient #22 (age 15) - testing performed on 01/29/19 (w) Patient #23 (age 5) - testing performed on 02/11/19 (x) Patient #24 (age 16) - testing performed on 02/12/19 (y) Patient #25 (age 16) - testing performed on 04/05/19 (z) Patient #26 (age 14) - testing performed on 04/22/19 (aa) Patient #27 (age13) - testing performed on 04/24/19 (3) The surveyor explained to office manager/testing person #3 and testing person #2 that specimens could only be tested on patients over the age of 18. 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 a review of records, written policy and interview with the office manager /testing person #3, the laboratory failed to have a written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for competency assessments performed during 2017, 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities; (2) The surveyor asked the office manager/testing person #3 if a written policy to evaluate the technical consultant based on job responsibilities was available. The office manager/testing person #3 stated a policy to evaluate the technical consultant based on job responsibilities had not been written; and competencies had not been performed. 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 office manager/testing person #3, the laboratory failed to review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program): (a) First 2017 Hematology Event (i) RDW (Red Cell Distribution Width) - 3 of 5 results exhibited a positive bias (aa) HEM-11 - SDI of 2.2 -- 2 of 3 -- (bb) HEM-12 - SDI of 2.1 (cc) HEM-15 - SDI of 2.2 (2) The surveyor further reviewed the records and could not locate documentation verifying the biases had been identified and addressed; (3) The surveyor then reviewed the records with the office manager/testing person #3, and asked if the biases had been addressed. The office manager/testing person #3 stated the biases had not been addressed. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager/testing person #3, the technical consultant failed to evaluate testing persons performing moderate complexity testing at least annually. Findings include: (1) At the beginning of the survey, the surveyor reviewed personnel records for 4 persons who performed moderate complexity testing during 2017 and 2018. For 2 of the 4 persons (testing person #3 and testing person #4), there was no evidence annual evaluations had been performed in 2018; (2) The surveyor reviewed the findings with the office manager /testing person #3. The office manager/testing person #3 stated the annual evaluations had not been performed as indicated above in 2018 for the testing persons. -- 3 of 3 --