Ohh Op Cath Lab-Mwc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/10/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with quality laboratory manager, point-of-care lead technologist, laboratory system director, and director of MWC/OPH/OHH at the conclusion of the survey. 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 review of policies and procedures and interviews with the quality laboratory manager, and point-of-care lead technologist, the written competency assessment policy did not define the frequency of the assessments for the technical consultant based on the position responsibilities for two of two technical consultants. Findings include: (1) A review of the competency assessment policy titled, "Poin-Of-Care Annual Competency Assessment - Technical Consultant - MWC Cath Lab" identified it did not define the frequency of the assessments; (2) Interview with the quality laboratory manager and point-of-care lead technologist on 09/10/2025 at 10:39 am confirmed that although the competencies based on the position responsibilities of the technical consultant had been performed annually, the policy did not define the frequency of assessments. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) 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 -- Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the quality laboratory manager and point-of-care lead technologist, the laboratory failed to perform calibration verification procedures at least once every six months for one of two AVOXimeter 1000E test systems during the review period of January 2024 through the current date. Findings include: (1) On 09/10/2025 at 10:00 am, the quality laboratory manager and point-of-care lead technologist stated the laboratory performed Oxyhemoglobin testing on two AVOXimeter 1000E analyzers (SN #3825 and SN #3826); (2) A review of records from January 2024 through the current date identified no evidence the calibration verification procedures had been performed for the AVOXimeter 1000E SN #3825 as follows; (a) Prior to 09/16/2024 (b) Between 09/16/2024 and 09 /05/2025 (3) The findings were reviewed with the quality laboratory manager and point-of-care lead technologist, who stated on 09/10/2025 at 01:35 pm, the calibration verification procedures had not been performed every six months as stated above. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of records and interview with the quality laboratory manager and point-of-care lead technologist, the laboratory failed to ensure test reports reflected the address of the laboratory location where the testing was performed for two of two reports reviewed. Findings include: (1) On 09/10/2025 at 10:00 am, the quality laboratory manager and point-of-care lead technologist stated the laboratory performed ACT (Activated Clotting Factor) testing using two i-STAT analyzers (SN #312507 and SN #330652) and Kaolin ACT cartridge; (2) A review of patient reports identified the address of the laboratory on the reports (4050 W. Memorial Rd. -- 2 of 3 -- Oklahoma City, OK 73120) did not match the address on the CLIA certificate (8121 National Ave., Ste.104, Midwest City, OK 73110) for the following: (a) Patient Medical Record #1346677 reported on 08/19/2025 (b) Patient Medical Record #1476213 reported on 08/27/2025 (3) The findings were reviewed with the quality laboratory manager and point-of-care lead technologist, who stated on 09/10/2025 02: 00 pm, the address on the patient reports did not match the CLIA certificate. 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 quality laboratory manager and point-of-care lead technologist, 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 one of five proficiency testing events reviewed in 2024 and 2025. Findings include: (1) On 09/10/2025 at 11:05 am, a review of 2024 and 2025 proficiency testing events identified attestation statements had been signed after the graded evaluations were completed by the proficiency testing program for one of five events reviewed: (a) Second event 2024 Chemistry- Core - The graded evaluation was completed on 06/21/2024 and the attestation statement had not been signed by the laboratory director until 06/21/2024; (2) The records were reviewed with the quality laboratory manager and point-of-care lead technologist who stated on 09/10/2025 at 11:07 am, the attestation statements had not been signed timely as stated above. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The initial survey was performed on 02/15/2022. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and laboratory manager at the conclusion of the survey. 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 and laboratory manager, the laboratory failed to ensure the laboratory procedure manual had been approved, signed, and dated by the laboratory director. Findings include: (1) On 02/15/2022 at 10:00 am, the technical consultant stated to the surveyor the laboratory began performing the following testing on 02/11/2021: (a) BUN, CO2, Creatinine, Glucose, Hemoglobin, Hematocrit, Ionized Calcium, Potassium, and Sodium testing using the iSTAT 1 analyzer and the Chem 8 + cartridge; (b) ACT (Activated Clotting Time) testing using the iSTAT 1 analyzer and the ACT Celite cartridge; (c) PT/INR (Prothrombin Time/International Normalized Ratio) testing using the iSTAT 1 analyzer and the PT/INR cartridge; (d) % Oxyhemoglobin testing using the Avoximeter 1000e analyzer. (2) The surveyor reviewed the laboratory manual titled, "OHH OPC-MWC Procedure Manual". It had not been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the technical consultant and laboratory manager. Both stated on 02/15/2022 at 01:50 pm, the procedure manual had not been approved, signed, and dated by the laboratory director. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(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 -- 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, procedure manual, and interview with the technical consultant and laboratory manager, the laboratory failed to ensure the reportable ranges were utilized for one of four new test methods; and failed to ensure the reportable ranges had been demonstrated for two of four new test methods. Findings include: REPORTABLE RANGES UTILIZED (1) On 02/15/2021 at 10:00 am, the technical consultant stated to the surveyor the laboratory began performing BUN, CO2, Creatinine, Glucose, Hemoglobin, Hematocrit, Ionized Calcium, Potassium, and Sodium testing using the iSTAT 1 analyzer and the Chem 8 + cartridge on 02/11 /2021; (2) The surveyor reviewed the performance specification records for the new test system and identified the laboratory had demonstrated the following reportable ranges: (a) BUN - 5-127 mg/dl (b) CO2 - 12-50 mmol/L (c) Creatinine - 0.2-16.7 mg /dl (d) Glucose - 27-582 mg/dl (e) Potassium - 2.3-7.9 mmol/L (3) The surveyor then reviewed the procedure manual to show the reportable ranges that were being utilized by the laboratory. The laboratory was using the following manufacturer's reportable ranges: (a) BUN - 3-140 mg/dl (b) CO2 - 5-50 mmol/L (c) Creatine - 0.2-20.0 mg/dl (d) Glucose - 20-700 mg/dl (e) Potassium - 2.0-9.0 mmol/L (4) The surveyor reviewed the findings with the technical consultant #1 and laboratory manager. Both stated on 02/15/2022 at 11:55 am, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory as shown above. REPORTABLE RANGES DEMONSTRATED (1) On 02/15/2021 at 10:00 am, the technical consultant stated to the surveyor the laboratory began performing ACT (Activated Clotting Time) testing using the iSTAT 1 analyzer and the ACT Celite cartridge and PT/INR (Prothrombin Time/International Normalized Ratio) testing using the iSTAT 1 analyzer and the PT/INR cartridge on 02/11/2021; (2) The surveyor reviewed the performance specification records for the new test systems and could not locate documentation to proved the laboratory had demonstrated the reportable ranges; (3) The surveyor reviewed the findings with the technical consultant and laboratory manager. Both stated on 02/15/2022 at 11:45 am, the laboratory did not demonstrate the reportable ranges for ACT and PT/INR testing. -- 2 of 2 --