Surgical Hospital Of Oklahoma, Llc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/18/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with technical consultant #1, technical consultant #2, and the paid 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 technical consultant #1, technical consultant #2, and the paid consultant the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director/designee and testing person for six of ten events reviewed. Findings include: (1) A review of 2022 and 2023 proficiency testing records identified the following for six of ten events: (a) 2022 Critical Care Blood Gas with Chemistry Survey - First Event (AQ-A), Second Event (AQ-B), and Third Event (AQ-C): (i) The attestation statements had not been signed by the laboratory director/designee and testing person(s); (b) 2022 Blood Oximetry Survey - First Event (SO-A), Second Event (SO-B), and Third Event (SO- C): (i) The attestation statement(s) had not been signed by the laboratory director 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 -- /designee and testing person(s); (2) The findings were reviewed with technical consultant #1, technical consultant #2, and the paid consultant. All stated on 08/18 /2023 at 12:35 pm, the attestation statements had not been signed as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial survey was performed on 08/26/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the administrator/chief clinical officer, technical consultant, and paid consultant during an exit conference performed at the conclusion of the survey. 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 paid consultant, the laboratory failed to ensure the reportable ranges were utilized for a new test method. Findings include: (1) On 08/26/2021 at 11:00 am, the paid consultant stated to the survyeor the laboratory began performing Hemoglobin, Sodium, and Chloride testing using the Radiometer ABP90 Flex Plus analyzer on 04/22/2020; (2) The surveyor reviewed the performance specification records for the new test system and identified the laboratory had demonstrated the following reportable ranges: (a) Hemoglobin - 4.9- 23.3 g/dl (b) Sodium - 79-177 mmol/L (c) Chloride - 46-120 mmol/L (3) The surveyor then requested documentation to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges instead of the ranges that had been demonstrated by the laboratory: (a) Hemoglobin - 4.5-24.0 g/dl (b) Sodium - 116-180 mmol/L (c) Chloride - 86-125 mmol/L (4) The surveyor reviewed the findings with the paid consultant who stated 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 -- on 08/26/2021 at 11:40 am, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown above. -- 2 of 2 --