Sapulpa Indian Health Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/25/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the quality improvement specialist, health administrator, technical consultant #2, and testing person #1 during an exit conference performed at the conclusion of the survey. 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 testing person #1, technical consultant #1, and technical consultant #2, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures for two of four analyzers. Findings include: CLINITEK ADVANTUS (1) On 03/25/2024 at 10:45 am, testing person #1 stated Urinalysis testing was performed using the Clinitek Advantus analyzer; (2) A review of the "Clinitek Advantus Operator's Guide", Chapter 5 "Maintenance", stated the following under the heading "Perform the Daily Cleaning": (a) "Clean the following parts at least once each day or after running 300 strips, whichever is more frequent": (i) "Push Bar" (ii) "Fixed Platform" (iii) "Moving Table" (iv) "Reagent Strip Holddown Plate" (3) A review of maintenance logs from 1/01/2023 through 01/31/2024 identified no documentation the daily maintenance had been performed as follows: (a) Between 11/06/2023 and 11/13 /2023 (b) Between 11/13/2023 and 11/21/2023 (c) Between 11/21/2023 and 11/27 /2023 (d) Between 11/27/2023 and 12/04/2023 (e) Between 12/04/2023 and 12/11 /2023 (f) Between 12/11/2023 and 12/18/2023 (g) Between 12/18/2023 and 12/27 /2023 (h) Between 12/27/2023 and 01/03/2024 (i) Between 01/03/2024 and 01/08 /2024 (j) Between 01/08/2024 and 01/16/2024 (k) Between 01/16/2024 and 01/23 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 -- /2024 (l) Between 01/23/2024 and 01/29/2024 (m) After 01/29/2024 (4) The records were reviewed with technical consultant #1 and technical consultant #2. Both stated on 03/25/2024 at 01:30 pm, the daily maintenance had not been documented as performed as shown above. CELL DYN RUBY (1) On 03/25/2024 at 10:50 am, testing person #1 stated CBC (Complete Blood Count) testing was performed using the Cell Dyn Ruby analyzer; (2) A review of the manufacturer's maintenance log showed the following required weekly maintenance procedures: (a) "Clean Loader Compartments" (3) A review of maintenance logs from December 2023 through February 2024 identified no documentation weekly maintenance had been performed between: (a) 12/15/2023 and 12/27/2023 (b) 01/12/2024 and 01/23/2024 (c) 02/16 /2024 and 02/26/2024 (4) The records were reviewed with technical consultant #2 who stated on 03/24/2024 at 02:25 pm, the weekly maintenance had not been documented as performed as shown above. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with technical consultant #2, the laboratory failed to ensure the urine centrifuge was functioning properly for two of four function checks performed during the review period of January 2022 through the current date. Finding include: (1) On 03/25/2024 at 02:00 pm, technical consultant #2 stated the following: (a) Urine sediment examinations were performed; (b) The specimens were processed in the Horizon Mini E 642 VES centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes. (2) A review of centrifuge function check records from January 2022 through the current date identified the centrifuge speed had not been checked at the speed urines were processed for two of four checks performed as follows: (a) 03/17/2023 - The speed had been checked at 4205 rpm (b) 09/12/2023 - the speed had been checked at 4205 rpm (3) The records were reviewed with technical consultant #2 who stated on 03/25/2024 at 02:45 pm, the laboratory had not ensured the centrifuge was functioning properly. 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 -- 2 of 3 -- 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 technical consultant #2 and testing person #1, the laboratory failed to perform calibration verification procedures at least once every six months for two of two analytes requiring calibration verification using the OCD (Ortho Clinical Diagnostics) Vitros ECi analyzer during the review period of April 2022 through the current date. Findings include: (1) On 03/25/2024 at 10:40 am, technical consultant #2 and testing person #1 stated Vitamin D and Vitamin B12 were performed on the OCD Vitros Eci analyzer; (2) A review of calibration records for 2023 identified the calibration procedures for the above analytes were performed with less than three levels of calibrators. Therefore, calibration verification procedures using three or more levels of calibration materials that included a low, mid, and high value, were required every six months; (3) A review of records from April 2022 through the current date identified calibration verifications had not been performed at least once every six months as follows: (a) Vitamin D - Not performed between 04/07 /2022 and 03/03/2023; (b) Vitamin B12 - Not performed between 04/07/2022 and 02 /22/2023, and between 02/22/2023 and 09/28/2023. (4) The records were reviewed with technical consultant #2 who stated on 03/25/2024 at 04:33 pm, calibration verification procedures had not been performed every six months as shown above. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/10/2022. The findings were reviewed with the laboratory supervisor and technical consultant at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 technical consultant, the laboratory failed to review and evaluate proficiency testing results for one of 28 events. Findings include: (1) On 03/10/2022, the surveyor reviewed 2020 and 2021 proficiency testing records and identified the following failures: (a) First 2020 Chemistry Core Event (i) ALT (Alanine Aminotransferase ) - The laboratory failed the results for one of five samples (CH-01); (ii) Total Iron - The laboratory failed the results for one of five samples (CH-03). (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) The surveyor reviewed the records with the technical consultant, and asked if

Summary Statement of Deficiencies D0000 The recertification survey was performed on 02/12/20 and 02/13/20. The findings were reviewed with the technical consultant and testing person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1409; D6033: Technical Consultant 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 the technical consultant and testing person #1, the laboratory director failed to sign a proficiency testing attestation statement for 1 of 23 events. Findings include: (1) At the beginning of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following for 1 of 23 events: (a) First 2019 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director. (2) The surveyor reviewed the findings with the technical consultant and testing person #1. Both stated the attestation statements had not been signed by the laboratory director. D3031 RETENTION REQUIREMENTS 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 -- 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, manufacturer's instructions, and interview with the technical consultant and testing person #1, the laboratory failed to maintain analytic test records for at least 2 years. Findings include: (1) At the beginning of the survey, the technical consultant and testing person #1 stated to the surveyor CBC (Complete Blood Count) testing was performed using the Cell-Dyn Ruby analyzer; (2) On the second day of the survey, the surveyor requested patient records, which contained morphologic flags (i.e., BAND, VAR LYM, RBC MORPH), from testing person #1. This was requested in order to determine if CBC morphologic flags obtained from testing on the analyzer had been verified according to the manufacturer's instructions and laboratory policy. Testing person #1 explained to the surveyor since patient information was transferred to their LIS (laboratory information system), the instrument printouts were not maintained; (3) While searching in the analyzer's memory, the technical consultant and testing person #1 stated to the surveyor patient data could not be retrieved prior to 09/18/18. Therefore, the surveyor could not determine if morphology flags, obtained from patient testing prior to 09/18/18 had been verified; (4) The surveyor explained to the technical consultant and testing person #1 that records of patient testing (instrument printouts) must be maintained for at least 2 years. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory director and testing person #1 at the conclusion of the survey. 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 testing person #1 and the laboratory director, the laboratory failed to evaluate proficiency testing results that had not been evaluated by the proficiency testing program. Findings include: (1) At the beginning of the survey, the laboratory director stated to the surveyor the laboratory performed macroscopic urinalysis testing using the Multistix 10SG reagent strips read on the Clinitek Advantus reader; (2) The surveyor reviewed proficiency testing records for urinalysis testing from the Second and Third events of 2016; and the First, Second, and Third events of 2017. The following was identified: (a) Third 2016 event: (i) Although the laboratory obtained a score of 100% for Urobilinogen, the result for sample UA-05, had not been evaluated by the proficiency testing program, due to "No Consensus" among the participants; (ii) In addition, the laboratory's result was "1.0 or Less than 2.0 mg/dl." The proficiency testing program's acceptable response was "See Data Summary"; (iii) There was no documentation located in the records which verified the laboratory identified the non-graded response, obtained the Data Summary, and performed a self-evaluation of the result to verify the accuracy of testing. (b) Second 2017 event: (i) Although the laboratory obtained a score of 100% for Urobilinogen, the result for sample UA-03, had not been evaluated 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 -- proficiency testing program, due to "No Consensus" among the participants; (ii) In addition, the laboratory's result was "1.0 or Less than 2.0 mg/dl." The proficiency testing program's acceptable response was "See Data Summary"; (iii) There was no documentation located in the records which verified the laboratory identified the non- graded response, obtained the Data Summary, and performed a self-evaluation of the result to verify the accuracy of testing. (3) The findings were reviewed with testing person #1 and the laboratory director, who verified the laboratory failed to identify the non-graded responses listed above, failed to obtain the Data Summary, and failed to perform a self-evaluation of the results. NOTE: D5215 was cited at the previous recertification survey performed 02/04,05/2016. 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 testing person #1, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: CELL DYN RUBY (1) At the beginning of the survey, the laboratory director stated to the surveyor the laboratory performed CBC (Complete Blood Count) testing (i.e. WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet Count, etc.) using the Cell Dyn Ruby hematology analyzer; (2) The surveyor reviewed the manufacturer's instructions (operator manual) for maintenance procedures. The manufacturer required the following weekly procedure: (a) Clean Loader Component (3) The surveyor then reviewed the maintenance records from 8 months (May and November 2016; March, August, October, November, and December 2017; and January 2018. During 6 of the 8 months reviewed, the weekly maintenance procedure had not been documented as having been performed, as follows: (a) November 2016: (i) Between 11/04/16 and 11 /15/16 (ii) Between 11/15/16 and 11/28/16 (b) March 2017: (i) Between 03/17/17 and 03/27/17 (c) August 2017: (i) Between 08/18/17 and 08/28/17 (d) November 2017: (i) Between 11/02/17 and 11/14/17 (e) December 2017: (i) Between 12/08/17 and 12/18 /17 (f) January 2018: (i) Between 01/12/18 and 01/22/18 (4) The surveyor reviewed the records with testing person #1 and the laboratory director who agreed performance of the manufacturer's required weekly maintenance had not been documented as having been performed as listed above. VITROS ECIQ (1) The laboratory director stated to the surveyor the laboratory performed chemistry and endocrinology testing (e.g. TSH-Thyroid Stimulating Hormone, PSA-Prostatic Specific Antigen, FT4-Free Thyroxine, Vitamin D, Vitamin B12, Folate, and Ferritin) using the Vitros ECiQ Immunoassay analyzer; (2) The surveyor reviewed the manufacturer's instructions for the required maintenance. The manufacturer required the following procedures: (a) "Weekly - Date/Initial Boxes": (i) Clean the sample metering proboscis (ii) Clean the tip disposal chute/cup retainer (iii) Clean the sample supply subsystem (iv) Clean the touchscreen monitor (v) Clean the keyboard and keyboard cover (vi) Perform subsystem cleaning (vii) Clean the processing center (b) "Monthly - Date/Initial Boxes": (i) Back up QC, Calibration, and Configuration Files (ii) Inspect the Reagent Cooler Filter (c) Every two months: Change the Vapor Adsorption Cartridge (d) Every three months: Change the Universal Wash Reservoir Filter (3) The surveyor then reviewed maintenance records from 22 months (03/01/16 through 01/31/17) and -- 2 of 3 -- identified the maintenance procedures had not been performed as required by the manufacturer. The specific findings follow: (a) Weekly: There was no evidence the weekly maintenance procedures were performed during 5 of the 22 months reviewed: (i) July 2016 - Week 4 (Between 07/18/16 and 08/02/16); (ii) March 2016 - Weeks 1, 2, 3, and 4: Although the boxes for the weekly maintenance had been checked, the dates on which the maintenace was performed had not been documented. Therefore, the surveyor could not determine if the maintenance had been performed on a weekly basis as required; (iii) April 2016 - Weeks 1, 2, 3, and 4: The dates on which the maintenace was performed had not been documented; (iv) May 2016 - Weeks 1, 2, and 3: The dates on which the maintenace was performed had not been documented; (v) April 2017 - Weeks 1, 2, 3, and 4: The dates on which the maintenace was performed had not been documented; (b) Monthly: There was no evidence the monthly maintenance procedures were performed during 16 of the 22 months reviewed, as follows: (i) March 2016 - There was no documentation the "Inspect the Reagent Cooler Filter" procedure had been performed; (ii) June 2016 - There was no documentation the "Inspect the Reagent Cooler Filter" procedure had been performed; (iii) August 2016 - There was no documentation the monthly procedures had been performed; (iv) November 2016 - There was no documentation the monthly procedures had been performed; (v) December 2016 - There was no documentation the monthly procedures had been performed; (vi) January 2017 - There was no documentation the monthly procedures had been performed; (vii) February 2017 - There was no documentation the monthly procedures had been performed; (viii) April 2017 - There was no documentation the "Inspect the Reagent Cooler Filter" procedure had been performed; (ix) May 2017 - There was no documentation the the "Inspect the Reagent Cooler Filter" procedure had been performed; (x) June 2017 - There was no documentation the monthly procedures had been performed; (xi) July 2017 - There was no documentation the monthly procedures had been performed; (xii) August 2017 - There was no documentation the monthly procedures had been performed; (xiii) September 2017 - There was no documentation the monthly procedures had been performed; (xiv) October 2017 - There was no documentation the monthly procedures had been performed; (xv) November 2017 - There was no documentation the "Inspect the Reagent Cooler Filter" procedure had been performed; (xvi) December 2017 - There was no documentation the monthly procedures had been performed. (c) Every two months: There was no documentation the maintenance was performed as required, as follows: (i) Had not been performed between 08/29/16 and 12/31/16 (ii) Had not been performed between 01/01/17 and 05/08/17 (iii) Had not been performed between 05/08/17 and 09/13/17 (d) Every three months (i.e. Quarterly): There was no documentation the quarterly maintenance was performed as required, as follows: (i) 2016: Had not been performed during the third quarter (not performed after 06/11/16 and prior to 10/13/16); (ii) 2017: Had not been performed during the first quarter (not performed after 01/01/17 and prior to 04/17/17). (4) The surveyor reviewed the findings with testing person #1 and the laboratory director who verified there was no documentation which showed the maintenance procedures listed above had been performed as required by the manufacturer. NOTE: D5429 was cited at the previous recertification survey performed on 02/04,05/2016. -- 3 of 3 --