Saint Francis Lab-Tulsa Hills

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/27/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory director the laboratory failed to ensure one of one Vacutainer brand tubes were stored as required by the manufacturer in the laboratory freezer. Findings include: (1) Observation of the laboratory freezer and interview with the laboratory director on 03/27/2024 at 10:38 am, identified the following: (a) One Vacutainer K2, EDTA tube, lot # 2321370, storage temperature of 4-25 degrees Celsius. (2) Interview with the laboratory director on 03/27/2024 at 10:38 am confirmed the tube was being stored below the manufacterer's stated temperature. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have 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 -- 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 director, the laboratory failed to ensure iSTAT cartridges had not exceeded their room temperature expiration date for one of four cartridge types observed. Findings include: CHEM 8+ (1) On 03/27/2024 at 11:30 am, the laboratory director stated Chem8+ (Na, Cl, Glucose, K, BUN, Creatinine, Ionized Calcium, and TCO2 ) testing was performed using the Chem8+ cartridge and the iSTAT 1 analyzer; (2) Observation of the laboratory on 03/27/2024 at 11:30 am identified five Chem8+ cartridges stored at room temperature (Lot #H24007), without documentation of when they were removed from refrigeration; (3) Review of the manufacturer's storage requirements showed the following: (a) The cartridges were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The cartridges were stable at room temperature (18-30 degrees C) for 14 days. TROPONIN I (1) On 03/27/2024 at 1130 am, the laboratory director stated troponin testing was performed using the cTnI cartridge and the iSTAT 1 analyzer; (2) Observation of the laboratory on 03/27/2024 at 11:30 am identified two cTnI cartridges stored at room temperature (Lot #B23249A), without documentation of when they were removed from refrigeration. (3) Review of the manufacturer's storage requirements showed the following: (a) The cartridges were stable at 2-8 degrees C (Centigrade) until the expiration date listed on the box; (b) The cartridges were stable at room temperature (18-30 degrees C) for 14 days. (4) Interview with the laboratory manager on 03/27/2024 at 11:42 am confirmed the cartridges had been placed at room temperature without any way to monitor if they exceeded the manufacturer's room temperature expiration date. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 laboratory director, the laboratory failed to verify the stated values of control materials before they were put into use for nine of nine lot numbers. Findings include: (1) On 03/27/2024 at 11:30 am, the laboratory director stated the following: (a) CBC (Complete Blood Count) testing was performed using the Beckman Coulter DxH 520 analyzer; (b) Three levels of QC (quality control) materials were tested daily; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) A review of records identified no evidence the provided ranges were verified before the lot numbers were -- 2 of 3 -- put into use for nine of nine lot numbers as follows: (a) Low control lot #362317911, Normal control lot #362314912, and High control lot #372314913 put into use on 08 /05/2023; (b) Low control lot #3523115111, Normal control lot #362315112, and High control lot #372315113put into use on 10/06/2023. (c) Low control lot #3523114711, Normal control lot #362314712, and High control lot #372314713 put into use on 06/06/2023. (3) The findings were reviewed with the laboratory director who stated on 03/27/2024 at 12:00 pm, the manufacturer's ranges had not been verified before the above lot numbers had been put into use. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/22/2021. The findings were reviewed with the technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, written policies, and interview with testing person #6 and the technical consultant the laboratory failed to follow written quality control policies for 3 of 3 test systems. Findings include: (1) On 11/22/2021 at 09:45 am, testing person #6 stated the following to the surveyor: (a) PT/INR (Prothrombin Time /International Normalized Ratio) testing was performed in the laboratory using the PT /INR cartridge and iSTAT 1 analyzer (serial number 373929); (b) Troponin testing was performed in the laboratory using the CTnl cartridge and iSTAT 1 analyzer (serial number 373929); (c) BNP (B-type Natriuretic Peptide) testing was performed in the laboratory using the BNP cartridge and iSTAT 1 analyzer (serial number 373929); (d) An IQCP (Individualized Quality Control Plan) had been developed for the above test systems. (2) The surveyor reviewed the IQCP that had been developed for each test system. The QCP (Quality Control Plan) portion of the IQCP required 2 levels of external quality control materials be tested once every 30 days; (3) The 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 -- surveyor reviewed QC (quality control) records for 22 months (January 2020 through October 2021) and identified the laboratory failed to follow the written QCP of performing quality control testing every 30 days. Quality control testing had not been performed as follows: (a) PT/INR (i) Between 03/06/2020 and 05/09/2020 (b) Troponin (i) Between 03/06/2020 and 05/09/2020 (c) BNP (i) Between 03/06/2020 and 05/09/2020 (ii) Between 03/25/2021 and 05/06/2021 (4) The findings were reviewed with the technical consultant who stated on 11/22/2021 at 12:45 pm, the laboratory had not performed quality control testing as required by the QCP. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (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 testing person #6 and the technical consultant, the laboratory failed to perform negative and positive control materials 2 of 2 days of patient qualitative serum pregnancy testing; and failed perform a negative and positive control materials 2 of 10 days of patient mononucleosis testing. Findings include: (1) On 11/22/2021 at 09:45 am, testing person #6 stated the following to the surveyor: (a) The laboratory performed qualitative serum pregnancy testing using the Beckman Icon 25 HCG test kit: (i) Positive and negative serum quality control (QC) materials were performed each day of patient testing. (b) The laboratory performed mononucleosis testing using the Remel Colorslide II test kit: (i) Positive and negative serum QC materials were performed each day of patient testing. (2) The surveyor reviewed QC and patient testing records between 10/03/2021 through 10/31/2021. The review showed that negative and positive QC materials had not been performed as follows: (a) Beckman Icon 25 HCG (i) For 2 of 2 days of patient testing reviewed. The specific days were 10/11/2021 and 10/27/201. (b) Remel Colorslide II (i) For 2 of 10 days of patient testing reviewed. The specific days were 10/06/2021 and 10/14 /2021. (3) The surveyor reviewed the records with the technical consultant, who stated on 11/22/2021 at 02:25 pm, negative and positive QC materials had not been performed as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 10/29/2019. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant, testing person #1, and the laboratory director at the conclusion of the survey. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to maintain records for 1 of 7 quality control lot numbers at least 2 years. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyor: (a) Hemogram (i.e WBC (White Blood count), RBC (Red Blood count), Hemoglobin, Hematocrit. MCV (Mean Corpuscular Volume), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), and Platelet count) testing was performed using the Abbott Emerald analyzer; (b) Three levels (Low, Normal, and High) of Cell Dyn 18 Plus quality control (QC) materials were analyzed each 8 hours of patient testing. (2) The surveyor reviewed QC records from 11/01/18 through the date of the survey and identified 7 lot numbers of QC materials had been utilized during the review period. The surveyor could not locate the manufacturer's assay value sheets for 1 of the 7 lot numbers (Lot #9014, used from 02/08/19-04/30/19); (3) The surveyor asked the technical consultant if the manufacturer's assay value sheet for the QC lot number listed above was available for review. The technical consultant stated to the surveyor 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 -- the QC assay sheet could not be located; (4) The surveyor reviewed the findings with the technical consultant and explained that all QC records must be maintained at least 2 years. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's specifications for establishing ranges for 1 of 7 quality control lot numbers. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyor: (a) Hemogram (i.e. WBC (White Blood count), RBC (Red Blood count), Hemoglobin, Hematocrit. MCV (Mean Corpuscular Volume), MCHC (Mean Corpuscular Hemoglobin Concentration), RDW (Red Cell Distribution Width), and Platelet count) testing was performed on the Abbott Emerald analyzer; (b) Three levels (Low, Normal, and High) of Cell Dyn 18 Plus quality control (QC) materials were analyzed each 8 hours of patient testing. (2) The surveyor reviewed the manufacturer's assay sheet for the control materials. The assay sheet designated a mean range for each analyte listed above and stated, "The MEAN RANGE does not represent standard deviations (SD)." The range was provided only as a guide to be used by the laboratory for establishing its own mean for each analyte; (3) The surveyor then reviewed the laboratory's QC records from 11/01/18 through the date of the survey. The surveyor identified 7 QC lot numbers had been used during the review period. For 1 of the 7 QC lot numbers reviewed (Lot #8295-used from 11/13/18 to 02 /08/19), the laboratory utilized the mean and range of means listed on the manufacturer's assay sheet as the acceptable QC limits for each analyte; (4) The surveyor reviewed the findings with the technical consultant who stated to the surveyor the laboratory had used the manufacturer's assay sheet mean and range of means as the acceptable QC limits for the lot number listed above and failed to establish its own QC mean and limits, as specified by the manufacturer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with technical consultant #1 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 director and technical consultant #1, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: BIAS (1) At the beginning of the survey, surveyor #2 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) 2016 Hematology 2nd Event - 5 of 5 results exhibited a negative bias for WBC (White Blood Cell): (i) Hem 01- SDI -1.9 (ii) Hem 02- SDI -3.3 (iii) Hem 03- SDI -3.4 (iv) Hem 04- SDI -4.5 (v) Hem 05 - SDI -4.5 (2) Surveyor #2 could not locate evidence in the records proving the biases had been identified and addressed; (3) Surveyor #2 reviewed the above findings with technical consultant #1 who stated the biases had not been identified and addressed. FAILURES (1) During the review of the proficiency testing records. The following failures were identified: (a) 2016 Hematology 2nd Event (i) Erythrocyte- The laboratory received a score of 20% (failed 4 of 5 results). There was no evidence that