Ascension St John Bartlesville

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/08/2024. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with technical consultant #2, the lab support person and the nurse manager at the conclusion of the survey. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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) 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 technical consultant, 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 -- laboratory failed to perform calibration verification procedures at least once every six months for the iSTAT test system during the review period of January 2022 through 05/15/2023. Findings include: (1) On 02/07/2024 at 02:00 pm, technical consultant #2 stated the following testing was performed using the iSTAT 1 analyzer (Serial Number 401690): (a) Sodium, Potassium, Chloride, CO2, Ionized Calcium, Glucose, BUN, and Creatinine testing using the Chem 8+ cartridge. (2) A review of records from January 2022 through the current date identified no evidence calibration verification had been performed at least once every six months as follows: (a) Chem 8+ Cartridge - Not performed between 01/01/2022 and the current date. (3) The records were reviewed with technical consultant #2 who stated on 02/07/2024 at 02:00 pm, calibration verification procedures had not been performed every six months as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/01/2022. The findings were reviewed with technical consultant #1 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records and interview with technical consultant #1, the laboratory failed to follow the written technical consultant competency policy based on the job responsibilities as listed in Subpart M for three of three technical consultants. Findings include: (1) The surveyor reviewed personnel records for competency assessments performed during 2020 and 2021. There was no evidence competencies had been performed for technical consultant #1, technical consultant #2, and technical consultant #3 based on job responsibilities in 2020; (2) The surveyor asked technical consultant #1 if a written policy to evaluate the technical consultants, based on job responsibilities, was available and if competencies had been performed during the review period. Technical consultant #1 stated to the surveyor on 02/01 /2022 at 02:10 pm, a policy to evaluate the technical consultants annually based on job responsibilities was written but competencies had not been documented as performed in 2020. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by 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 3 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to follow the calibration verification procedure for one of two calibrations. Findings include: (1) On 02/01/2022 at 01:45 pm, technical consultant #1 stated the following to the surveyor: (a) BUN, Chloride, Creatinine, Ionized Calcium, Potassium, Sodium, and TO2 (Chem 8+ cartridge) was performed on the iSTAT (serial number 21401690) analyzer; (2) The surveyor reviewed the laboratory's written IQCP procedure and under the section titled, "4. Calibration Verification" it stated, "a. Calibration verification material is available from the manufacturer. Calibration verification will be performed twice per year."; (3) The surveyor reviewed 2021 and 2022 calibration verification records through the day of the survey (02/01/2022) and identified the following: (a) Calibration had not been performed since 06/12/2021. (4) The surveyor reviewed the findings with technical consultant #1. Technical consultant #1 stated on 02/01/2022 at 02:45 pm, the calibration verification procedure had not been followed as indicated above. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 technical consultant #1, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for two of 24 months. Findings include: (1) On 02/01/2022 at 01:45 pm, technical consultant #1 stated to the surveyor that CBC (Complete Blood Count) testing was performed on the Sysmex XP-300 analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements as stated on the manufacturer's maintenance logs. (a) Weekly maintenance (i) Clean SRV Tray (b) Quarterly maintenance (i) Clean SRV (3) The surveyor reviewed maintenance records for 24 months (January 2020 through December 2021) and identified the following: (a) There was no evidence the weekly maintenance had been performed (i) Between 06 /01/2021 and 06/15/2021 (ii) Between 06/15/2021 and 07/06/2021 (b) There was no evidence the quarterly maintenance had been performed (i) Since 07/01/2021 (4) The surveyor reviewed the records with technical consultant #1, who stated on 02/01/2022 at 02:20 pm, the weekly maintenance and quarterly had not been documented as performed as required. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #1, the laboratory failed to follow their policy for monitoring the effectiveness of their IQCP. Findings include: (1) On 02/01/2022 at 01:45 pm, technical consultant #1 stated the following to the surveyor: (a) BUN, Chloride, Creatinine, Ionized Calcium, Potassium, Sodium, and TO2 (Chem 8+ cartridge) was performed on the iSTAT (serial number 21401690) analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as approved on 06/30/2020). The section titled, "Quality Assessment Monitoring" stated, "a. Monitoring of this plan will occur annually at minimum, and reevaluation will be considered whey any changes occur with the following: Testing personnel, environment, specimens, reagents, test system."; (3) The surveyor reviewed records for 2020 and 2021 and could not locate annual QA reviews since the IQCP had been approved on 06/30/2020; (4) The surveyor reviewed the records with technical consultant #1 and asked if there was documentation of a QA review to evaluate the QCP annually. Technical consultant #1 stated to the surveyor on 02/01 /2022 at 02:10 pm a QA review had not been documented as performed annually as stated in the policy. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/25/19. The findings were reviewed with the laboratory coordinator and technical consultant #1 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 a review of records, written policy and interview with the laboratory coordinator, the laboratory failed to follow their written technical consultant competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) During the survey, the surveyor reviewed personnel records for competency assessments performed during 2018 and 2019. There was no evidence competencies had been performed for the technical consultant, based on their job responsibilities; (2) The surveyor asked the laboratory coordinator if a written policy to evaluate the technical consultant based on job responsibilities was available. The technical consultant provided the policy for the surveyor to review titled: "Technical Consultant Competency"; (3) The surveyor reviewed the policy which stated, "The Technical Consultant will be evaluated for competency by the laboratory director on an annual basis. This will be accomplished during one of the regular quarterly meetings of the Laboratory Director to the St. John Urgent Care."; (4) The surveyor asked the laboratory coordinator if competencies based on job responsibilities had been performed during the review period as required by policy. The laboratory coordinator stated annual competencies had not been performed. 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 coordinator, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) At the beginning of the survey, the laboratory coordinator stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex XP-300 analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's weekly maintenance requirements as stated on the manufacturer's maintenance logs: (a) Clean SRV Tray (3) The surveyor then reviewed maintenance records from April 2018 through September 2019. There was no evidence the weekly maintenance had been performed: (a) Between 06/19/18 and 07/01//18 (4) The surveyor reviewed the records with the laboratory coordinator, who stated the weekly maintenance had not been documented as performed as indicated above. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that 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 laboratory coordinator, 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 1 of 5 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records. It was identified for 1 of 5 events, the attestation statements had been signed approximately 3 months after the samples had been tested (not within a timeframe for the director to attest that, at the time of testing, the proficiency samples had been tested as required) as follows: (a) Hematology Second event of 2018 - The samples had been tested on 07/26/18 and the attestation statement had not been signed by the laboratory director until 10/10/18; (2) The surveyor reviewed the findings with the laboratory coordinator and explained that attestation statements must be signed within a timeframe to definitively attest to the fact that proficiency samples were tested in the same manner as patient specimens. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with technical consultant #4 and the laboratory coordinator 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, and interview with technical consultant #4 and the laboratory coordinator, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: (1) At the beginning of the survey, technical consultant #4 and the laboratory coordinator stated to the surveyor the laboratory performed Chemistry testing (e.g. Sodium, Potassium, Chloride, CO2, BUN (Blood Urea Nitrogen), and Creatinine) on patient venous whole blood samples using the i-STAT analyzer and Chem 8+ test cartridges; (2) The surveyor reviewed the manufacturer's instructions for the i-STAT (page 16), which stated: (a) "For acceptance of newly received cartridge lots, check the Temperature Monitor and perform integrity testing."; (b) "Check Temperature Monitor: i-STAT cartridges are shipped with a four-window indicator to monitor temperature during transit." (i) "Action:" (aa) "Fill out the record of receipt and forward materials to refrigerator." (bb) "If all windows are white, or the 1 or 2 windows are red, the transit temperatures were satisfactory and the cartridges can be used." (ii) "Remedial Action:" (aa) "If the C or D windows are blue, or the 3 or 4 windows are red": (i) "Quarantine the suspect cartons" (ii) "Notify the i-STAT system coordinator immediately" (iii) "DO NOT USE cartridges from suspect cartons." (3) The surveyor reviewed i-STAT QC (Quality Control) records from 01/01/17 through 03/01/18, which included records of newly received shipments of Chem 8+ test cartridges. 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 4 -- surveyor could not find documentation of the condition of the Temperature Monitor strip for each new shipment; (4) The surveyor asked the laboratory coordinator if the laboratory checked and documented the condition of the Temperature Monitor strip included in each shipment. The laboratory coordinator stated to the surveyor the condition of the temperature strip was observed, but had not been documented. The surveyor determined there was no evidence the transit temperature of newly received shipments of i-STAT test cartridges had been acceptable; (5) The surveyor reviewed the findings with technical consultant #4 and the laboratory coordinator, who agreed the laboratory failed to document the condition of the Temperature Monitor strip included in new shipments of i-STAT test cartridges as required by the manufacturer to ensure transit temperatures were acceptable. 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 a review of records, manufacturer's instructions, and interview with technical consultant #4 and the laboratory coordinator, the laboratory failed to ensure an analyzer was stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, technical consultant #4 and the laboratory coordinator stated to the surveyor the laboratory began patient CBC (Complete Blood Count) (i.e. WBC- White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) testing on 09/06/16 using the Sysmex XP 300 analyzer; (2) Later during the survey, the surveyor reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the relative humidity be maintained within the range of 30-85%; (3) The surveyor reviewed laboratory humidity records from October 2016 through February 2018 which verified the humidity readings were less than 30% for 7 of 17 months as follows: (a) December 2016 - 16 of 30 humidity readings were documented as less than 30%: Days: 13,15, 16,18,19,20,21,22,23,24,26,27,28,29,30,31 (b) January 2017- 20 of 31 humidity readings were documented as less than 30%: Days: 1,4, 5,6,7,8,9,12,13,14,15,23,24,25,26,27,28,29,30, 31 (c) February 2017 - 15 of 28 humidity readings were documented as less than 30%: Days: 1,2,3, 4,5,8,9,10,13,15,16,17,25,26,27 (d) March 2017 - 11 of 31 humidity readings were documented as less than 30%: Days: 2,4, 7,8,10,11,12,13,14,15,16 (e) October 2017 - 3 of 31 humidity readings were documented as less than 30%: Days: 28, 29,31 (f) November 2017 - 1 of 30 humidity readings was documented as less than 30%: Day: 23 (g) December 2017 - 19 of 30 humidity readings were documented as less than 30%: Days: 6,7, 8,9,10,11,12,13,14,15,16,23,24,26,27,28,29,30, 31 (4) The surveyor reviewed the findings with technical consultant #4 and the laboratory coordinator who stated the laboratory failed to ensure the manufacturer's required humidity requirements had been met, as indicated above. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE -- 2 of 4 -- 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 technical consultant #4 and the laboratory coordinator, the laboratory failed to ensure reference intervals used with a new analyzer, had been determined as acceptable for the patient population it serviced. Findings include: (1) At the beginning of the survey, technical consultant #4 and the laboratory coordinator stated to the surveyor the laboratory began patient CBC (Complete Blood Count) (i.e. WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) testing on 09/06/16 using the Sysmex XP 300 analyzer. In addition, technical consultant #4 stated to the surveyor the laboratory erformed CBC testing on pediatric patients (less than 18 years of age); (2) Later during the survey, the surveyor reviewed the laboratory's implementation records for the analyzer performed from 08/15/16 through 09/05/16. There was no evidence in the records the laboratory had established or verified reference intervals (normal ranges) for pediatric patients; (3) The surveyor asked technical consultant #4 and the laboratory coordinator if the laboratory had established or verified pediatric reference intervals for the pediatric patient population it serviced. Technical consultant #4 and the laboratory coordinator explained the laboratory used published reference intervals for pediatric patient CBC's but the laboratory had not verified the ranges were appropriate for the patient population it serviced; (4) The surveyor then reviewed 6 CBC (2 adult patients and 4 pediatric patients) test reports of testing performed between September 2017 and the day of the survey in 2018. For 4 of the 4 pediatric CBC test reports reviewed, the laboratory failed to have reference intervals specific for pediatric patients. Examples follow: (a) Patient #1 - 16 year old female with testing performed on 09/06/17: Normal reference ranges for Adult Females were included on the test report: (i) WBC: 3.1-10.3 (ii) RBC: 3.2-4.6 (iii) Hemoglobin: 9.9- 13.6 (iv) Hematocrit: 30.2-42.3 (v) Platelet: 128-434 (vi) Lymphocyte %: 15.0-45.8 (vii) Neutrophil %: 43.7-77.1 (b) Patient #2 - 12 year old male with testing performed on 10/25/17: Normal reference ranges for Adult Males were included on the test report: (i) WBC: 2.6-8.8 (ii) RBC: 3.6-5.3 (iii) Hemoglobin: 11.3-15.7 (iv) Hematocrit: 32.6-47.5 (v) Platelet: 134-377 (vi) Lymphocyte %: 17.5-47.9 (vii) Neutrophil %: 38.3-69.0 (c) Patient #3 - 11 year old female with testing performed on 03/13/18: Normal reference ranges for Adult Females were included on the test report: (i) WBC: 2.6-8.8 (ii) RBC: 3.6-5.3 (iii) Hemoglobin: 11.3-15.7 (iv) Hematocrit: 32.6- 47.5 (v) Platelet: 134-377 (vi) Lymphocyte %: 17.5-47.9 (vii) Neutrophil %: 38.3- 69.0 (d) Patient #4 - 17 year old male with testing performed on 03/13/18: Normal reference ranges for Adult Males were included on the test report: (i) WBC: 2.6-8.8 (ii) RBC: 3.6-5.3 (iii) Hemoglobin: 11.3-15.7 (iv) Hematocrit: 32.6-47.5 (v) Platelet: 134-377 (vi) Lymphocyte %: 17.5-47.9 (vii) Neutrophil %: 38.3-69.0 NOTE: The Interpretive Guidelines for 493.1253(b)(1) state, "The laboratory may use the manufacturer's reference range provided it is appropriate for the laboratory's patient population (i.e., a normal range that reflects the type of specimen and demographic variables such as age and sex, as applicable). If the manufacturer has not provided -- 3 of 4 -- reference ranges appropriate for the laboratory's patient population, the laboratory may use published reference range(s). The laboratory must evaluate an appropriate number of specimens to verify the manufacturer's claims for normal values or, as applicable, the published reference ranges." D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #4 and the laboratory coordinator, the laboratory failed to ensure pediatric reference intervals were made available to the provider for interpretation. Findings include: (1) At the beginning of the survey, technical consultant #4 and the laboratory coordinator stated to the surveyor the laboratory began patient CBC (Complete Blood Count) (i.e. WBC- White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, Lymphocyte%, Neutrophil %, etc.) testing on 09/06/16 using the Sysmex XP 300 analyzer. In addition, technical consultant #4 stated to the surveyor the laboratory performed CBC testing on pediatric patients (less than 18 years of age); (2) Later in the survey, the surveyor reviewed 6 CBC test reports of patient testing performed between September 2017 and the day of the survey in March 2018 (2 adult patients and 4 pediatric patients). The reports included reference intervals for adult male and adult female patients, but did not include reference intervals for pediatric patients on 4 of the 4 pediatric patient CBC reports reviewed, as follows: (a) Patient #1 - 16 year old female: Testing performed on 09/06/17 (b) Patient #2 - 12 year old male: Testing performed on 10/25/17 (c) Patient #4 - 11 year old female: Testing performed on 03/13 /18 (d) Patient #5 - 17 year old male: Testing performed on 03/13/18 (3) The test reports of pediatric patient CBC testing included the same reference intervals as for adults, for the CBC parameters of WBC, RBC, Hemoglobin, Hematocrit, Platelet, Lymphocyte % and Neutrophil %, which were: (a) WBC: (i) Male: 2.6-8.8 (ii) Female: 3.1-10.3 (b) RBC: (i) Male: 3.6-5.3 (ii) Female: 3.2-4.6 (c) Hemoglobin: (i) Male: 11.3-15.7 (ii) Female: 9.9-13.6 (d) Hematocrit: (i) Male: 32.6-47.5 (ii) Female: 30.2-42.3 (e) Platelet: (i) Male: 134-377 (ii) Female: 128-434 (f) Lymphocyte %: (i) Male: 17.5-47.9 (ii) Female: 15.0-45.8 (g) Neutrophil%: (i) Male: 38.3-69.0 (ii) Female: 43.7-77.1 (4) The surveyor reviewed the findings with technical consultant #4 and the laboratory coordinator, who stated to the surveyor the laboratory failed to include CBC reference intervals specific for pediatric patients on the test reports, as listed above. -- 4 of 4 --