Diagnostic Laboratory Of Oklahoma

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/19,20/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the lab manager, lead tech, quality assurance specialist, director of hospital operations, and the laboratory director during an exit conference performed at the conclusion of the survey. 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 laboratory manager, the laboratory failed to review and evaluate proficiency testing results for one of five Chemistry proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 11/19/2024, a review of Chemistry proficiency testing records for 2023 (first, second, and third events) and 2024 (first and second events) identified the following biases (biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency program) for one of five events: (a) CAP C-A 2024 General Chemistry Event (i) Lipase - five of five results exhibited a positive bias (aa) Sample CHM-01 - SDI of 2.6 (bb) Sample CHM-02 - SDI of 2.9 (cc) Sample CHM- 03 - SDI of 1.0 (dd) Sample DXH-04 - SDI of 3.7 (ee) Sample DXH-05 - SDI of 3.0 (2) There was no evidence in the records to prove the biases had been identified and addressed; (3) The records were reviewed with the laboratory manager who stated on 11/19/2024 at 01:40 pm, the biases had not been addressed. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the laboratory manager, the laboratory failed to ensure Citrol quality control materials had not exceeded their open vial expiration date for two of two vials observed. Findings include: (1) On 11/19 /2024 at 1:30 pm, the laboratory manager stated coagulation testing was performed using the Sysmex CA-600 series analyzer and two levels of Citrol quality control materials were performed each eight hour of patient testing; (2) Observation of the laboratory on 11/19/2024 at 1:30 pm identified two bottles of Citrol quality control material stored refrigerated, without documentation of when they were opened and reconstituted; (3) Review of the manufacturer's storage requirements showed the following: (a) The vials were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The vials were stable refrigerated for 16 hours after reconstitution. (4) Interview with the laboratory manager on 11/19/2024 at 1:30 pm confirmed the Citrol vials had not been dated with the 16 hour expiration date. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/21, 22, 23/2021 The findings were reviewed with the laboratory director, technical supervisor, general supervisor #1, quality assessment specialist, laboratory operations director, and the laboratory regional manager during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the quality assurance specialist and general supervisor #1, the laboratory failed to follow the manufacturer's instructions for implementing reagents for two of two lot numbers. Findings include: (1) On 02/23/2021 at 10:30 am, the general supervisor #1 stated to the surveyor PT/INR (Protime/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Sysmex CA-620 analyzer (note: the INR value was calculated using the normal patient PT geometric mean determined by the laboratory). General supervisor #1 also stated the following lot numbers had been put into use on 10/12/2020: (a) PT reagent - Dade Innovin lot #549772B (b) PTT reagent - Dade Actin FSL lot #562615A (2) The surveyor reviewed the manufacturer's implementation instructions, titled "Hemostasis Laboratory Reagent Lot Roll-Over Studies CA-500/600 Series"; (a) Section I titled "Verification of Reference Range" stated: (i) "A. 20 Normal Individuals" * "10 males; 10 females representing reference population. 20 is the minimum requirement for a statistically valid study." * "Fresh samples preferred but frozen platelet poor plasma may be used if prepared and thawed 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 -- per CLSI Guidelines." * "Note medication history. After review of data, history may be used for excluding abhorrent results." (ii) "B. Assay samples on current and new lot number reagents simultaneously or within 1 hour of each other." (3) The surveyor reviewed the implementation records for the reagent lot change. The following was identified: (a) PT - Although the laboratory had screened 20 normal individuals as stated above, they only assayed 14 of the normal samples using the current and new lot reagent numbers simultaneously; (b) PTT - Although the laboratory had screened 20 normal individuals as stated above, they only assayed 10 of the normal samples using the current and new lot reagent numbers simultaneously. (4) The surveyor reviewed the findings with the quality assurance specialist and general supervisor #1. On 02/23/2021 at 11:30 am, both stated the laboratory had not followed the manufacturer's instructions as indicated above. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the quality assurance specialist, general supervisor #1, and technical supervisor, the laboratory failed to have control procedures that monitored the accuracy and precision of the complete analytic process for 2 of 2 lot numbers of coagulation control materials and 1 of 1 lot number of glucose control material. Findings include: COAGULATION CONTROL MATERIAL (1) On 02/23/2021 at 10:30 am, general supervisor #1 stated the following to the surveyor: (a) PT/INR (Protime/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Sysmex CA-620 analyzer; (b) Two levels of Dade CiTrol quality control (QC) materials (level 1 and level 3) were performed each eight hours of patient testing; (c) Established means and ranges were used for determining acceptability of QC results. (2) The surveyor reviewed coagulation records and identified QC level 3 lot #556532 had been put into use on 10/12/2020. The documentation showed the following means had been established by the laboratory: (a) PT Level 3 - 46.9 (b) PTT Level 3 - 55.5 (3) The surveyor reviewed QC records, which consisted of laboratory worksheets utilized while establishing QC ranges, Levey-Jennings graphs, and cumulative data generated from the analyzer from 11/02/2020 through 11/30/2020. The documentation showed the established means had not been updated in the analyzer and had not put into use. The laboratory was using the following means: (a) PT Level 3 - 45.9 (b) PTT Level 3 - 55.0 (4) The surveyor reviewed the records with the quality assurance specialist, general supervisor #1, and technical supervisor. The general supervisor #1 stated on 02 /23/2021 at 11:45 am the following: (a) The laboratory had not updated the established means in the analyzer when the materials had been put into use on 10/12 /2020; (b) The laboratory had carried over the means that had been used for the -- 2 of 3 -- previous lot number of QC for PT level 3 and PTT level 3 instead of entering their established means. GLUCOSE QUALITY CONTROL MATERIAL (1) On 02/24 /2021 at 02:00 pm, general supervisor #1 stated the following to the surveyor: (a) Glucose testing was performed on the Abbott Architect analyzer; (b) Three levels of BioRad Unassayed MultiQual quality control (QC) materials (level 1, level 2, and level 3) were performed each day of patient testing; (c) Established mean and ranges were used for determining acceptability of QC results. (2) The surveyor reviewed Glucose records and identified QC level 3 lot #56663 had been put into use on 08/01 /2020. The documentation showed the following mean had been established by the laboratory: (a) Glucose Level 3 - 371 (3) The surveyor reviewed QC records, which consisted of laboratory worksheets utilized while establishing QC ranges, Levey- Jennings graphs, and cumulative data generated from the analyzer from 08/01/2020 through 08/30/2020. The documentation showed the established mean had not been updated in the analyzer and had not put into use. The laboratory was using the following mean: (a) Glucose Level 3 - 361.7 (4) The surveyor reviewed the records with the general supervisor #1. The general supervisor #1 stated on 02/24/2021 at 03: 00 pm the following: (a) The laboratory had not updated the established mean in the analyzer when the material had been put into use on 08/01/2020; (b) The laboratory had carried over the mean that had been used for the previous lot number of QC for Glucose level 3 instead of entering their established mean. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Recertification survey was performed on 11/06/18 and 11/07/18. The findings were reviewed with the laboratory manager, quality assessment specialist, technical supervisor and lab manager during an exit conference performed at the conclusion of the survey. The laboratory was found to be in compliance with standard-level deficiencies cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the lead technologist and quality assessment specialist, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) On the first day of the survey, surveyor #2 reviewed 2017, and 2018 proficiency testing records and identified the following had not been evaluated by the proficiency testing program: (a) General Chemistry/Therapeutic Drugs (i) C-A 2017 event (aa) Sodium - CHM-01 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the laboratory had performed a self-evaluation of the non- graded results; (3) Surveyor #2 asked the lead technologist and quality assessment specialisit if the results had been documented as evaluated. They both reviewed the records and stated the non-graded results had not been documented as reviewed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 3 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the QA specialist and lead technologist, the laboratory failed to follow the manufacturer's instructions for implementing reagents. Findings include: (1) On the first day of the survey, the lead technologist stated to surveyor #1 PT/INR (Protime/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed on the Sysmex CA-620 analyzer (note: the INR value was calculated using the normal patient PT geometric mean determined by the laboratory). The lead technologist also stated the following lot numbers had been put into use on 07/01/18: (a) PT reagent - Dade Innovin lot #549715A (b) PTT reagent - Dade Actin FSL lot #556926 (c) Dade CiTrol control level 1 lot #548074 (d) Dade CiTrol control level 3 lot #556501 (2) On the second day of the survey, surveyor #1 reviewed the manufacturer's implementation instructions for new reagent lot numbers (the surveyor had a copy of the manufacturer's implementation instructions obtained from another laboratory). For the method correlation and quality control sections, the instructions stated: (a) Section II titled "Method Correlation" stated: (i) "40 samples: 20 normal, 20 abnormal *Normal samples (Section I) may be used for the Method Correlation and Verification of Reference Range" *Abnormal Samples should span the Reportable Range of assay" (ii) "Assay samples of current and new lot number reagents simultaneously or within 1 hour of each other" (iii) "Calculate Linear Regression statistics" (b) Section III titled "Quality Control" stated: (i) "Assay new lot number of QC material with the new lot of reagent in PTN and APTTN protocols" (ii) "Collect a minimum of 30 data points over multiple days and stability limits of control" (iii) "Calculate the mean, 2 SD and 3 SD range" (3) Surveyor #1 reviewed the implementation records for the reagent lot changes. The following was identified: (a) For the method correlation, the laboratory had not used 20 normal and 20 abnormal samples as follows: (i) PT - The laboratory had used 9 normal and 31 abnormal samples; (ii) PTT - The laboratory had used 19 normal and 21 abnormal samples. (b) For the quality control, the laboratory had not used a minimum of 30 data points as follows: (i) Level 1 PT and PTT - The laboratory had used 25 data points: (ii) Level 3 PT and PTT - The laboratory had used 25 data points. (4) Surveyor #1 reviewed the findings with the QA specialist and lead technologist. Both stated the laboratory had not followed the manufacturer's instructions as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical supervisor, laboratory manager, QA specialist, and lead technologist, the laboratory failed to have a policy -- 2 of 3 -- for monitoring the effectiveness of their IQCP. Findings include: (1) On the first day of the survey, the lead technologist stated the following to surveyor #1: (a) The laboratory performed Serum Qualitative Pregnancy testing using the Fisher Healthcare Sure-Vue Serum/Urine hCG test kit; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test. (2) Surveyor #1 reviewed the IQCP (dated as approved on 12/11/15) and identified the following: (a) Although a QA (Quality Assessment) review had been performed on 01/25/18 (as a review for 2017), only the front page of the two-sided form had been completed, therefore, surveyor #1 determined the review was incomplete; (b) The QA portion of the IQCP did not address how the laboratory will monitor the QCP (Quality Control Plan) and did not specify the frequency for evaluating the QCP to ensure it continued to provide accurate and reliable results. (3) Surveyor #1 reviewed the records with the technical supervisor, laboratory manager, QA specialist, and lead technologist, and asked if there was a policy to address how the laboratory will monitor the QCP, including the frequency of the reviews and if there was additional documentation to show a complete QA review had been performed on 01/25/18. All of the persons stated that QA reviews were to be performed annually, but the laboratory did not have a policy that specified how the QCP will be monitored and the frequency. In addition, they stated that the QA review performed on 01/25/18 was not complete. -- 3 of 3 --