Integris Health Medical Group

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/30/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and office manager 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 storage and expiration dates of testing kits. Findings include: EXPIRED REAGENTS: (1) On 01/30/2024 at 1:00 pm, testing person #1 stated waived testing was performed in the sick area of the clinic; (2) Observation of the sick area on 01/30/2024 at 01:00 pm identifed two Hemoccult Developer bottles, lot #75009H, that expired on 09/2023; (3) The findings were discussed with testing person #1 who stated on 01/30/2024 at 1:00 pm, the developers were expired and still available for use. TEMPERATURE MONITORING: (1) Observation of the store room and interview with testing person #1 on 01/30/2024 at 12:00 pm, identified the following: (a) 11 boxes of Quidel QuikVue Influenza A+B test kits, lot # 708943, storage temperature of 15-30 degrees Celsius; (b) One box of Quidel QuickVue RSV tests, lot # 708024, storage temperature of 15-30 degrees Celsius; (c) Seven boxes of Sure-Vue Strep A test kits, lot # 0000695055, storage temperature of 2-30 degrees Celsius. (2) Interview with testing person #1 on 01/30/2024 at 12:00 pm confirmed the laboratory was not monitoring the temperature of the store room. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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): 493.1235 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 policies and procedures, and interview with the clinic manager, the laboratory failed to have a written policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of January 2022 through the current date identified competencies, based on job responsibilities, had not been performed for one of one person listed as the technical consultant; (3) The findings were reviewed with the clinic manager who stated on 01/30/2024 at 1:00 pm a policy had not been written and competencies had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 03/22/2022. The findings were reviewed with the laboratory manager, office manager, and laboratory director during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager, laboratory manager and laboratory director, the laboratory failed to demonstrate the reportable range for one of one new test system. Findings include: (1) On 03/22/2022 at 01:10 pm, the laboratory manager stated: (a) The laboratory began performing CBC (Complete Blood Count) testing using the Medonic analyzer on 03/11/2021. (2) A review of the performance specification records did not include any evidence the laboratory had demonstrated the reportable ranges for each analyte; (3) On 03/22 /2022 at 02:40 pm, the laboratory manager stated the reportable ranges had not been demonstrated. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(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 2 -- 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 the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for 12 of 12 months. Findings include: (1) On 03 /22/2022 at 01:10 pm, the laboratory manager stated: (a) CBC (Complete Blood Count) testing was performed using the Medonic analyzer. (2) A review of the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs: (a) Daily Maintenance (i) Clean the aspiration and pre-dilute probes using an alcohol wipe; (ii) Remove possible traces of salt crystals or blood at the top of the aspiration and pre-dilute probes, probe rinse cup, and around top of sampling device probe inlet using a paper tissue with a disinfecting solution. (3) A review of maintenance records for 12 months (March 2021 through March 2022) revealed the following: (a) There was no evidence the daily maintenance had been documented as performed during the review period. (4) The records were reviewed with the laboratory manager. The laboratory manager stated on 03/22/2022 at 03:15 pm, the maintenance had been performed but not documented. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager, laboratory manager and the laboratory director, the laboratory director failed to ensure that persons performing moderate complexity testing had the appropriate training for two of four testing persons. Findings include: (1) On 03/22/2022, a review of personnel records revealed the following: (a) Testing Person #1 - This person was hired to perform patient CBC (Complete Blood Count) testing using the Medonic analyzer. There was no documentation of initial training; (b) Testing Person #2 - This person was hired to perform patient CBC (Complete Blood Count) testing using the Medonic analyzer. There was no documentation of initial training. (2) The findings were reviewed with the laboratory manager. On 03/22/2022 at 02:15 pm the laboratory manager stated there was no additional documentation to prove the above persons had been initially trained to perform moderate complexity testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the chief quality officer, clinic manager, and testing person #1 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 chief quality officer and testing person #1, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2016 and 2017 proficiency testing records. The following was identified for 1 of 6 testing events: (a) Third 2016 Hematology Event (i) The attestation was not signed by the laboratory director. (2) The findings were reviewed with the chief quality officer and testing person #1 who stated the attestation was not signed as indicated above. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 chief quality officer and testing person #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: BIAS (1) At the beginning of the survey, the surveyor reviewed 2016 and 2017 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) First 2017 Hematology Event (i) MCH (Mean Corpuscular Hemoglobin) - 4 of 5 results exhibited a positive bias (aa) HEM-01 - SDI 2.0 (bb) HEM-02 - SDI 2.4 (cc) HEM-03 - SDI 2.7 (dd) HEM-04 - SDI 2.7 (2) The surveyor could not locate evidence in the records proving the biases had been identified and addressed; (3) The surveyor reviewed the above findings with the chief quality officer and testing person #1 who stated the biases had not been addressed. FAILURES (1) During the review of proficiency testing records, the surveyor identified the following failures, in which