Absentee Shawnee Tribal Health System -

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/01,02/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director and laboratory manager at the conclusion of the survey. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager, the laboratory failed to label three of three containers with the identity, expiration date, and lot number of the contents. Findings include: (1) On 04/01/2025 at 10:20 am, the laboratory manager stated the laboratory stained peripheral blood smears to perform manual differential testing; (2) Observation on 04/01/2025 at 10:22 am identified three unlabeled Coplin jars, appearing to contain materials used to stain peripheral blood smears; (3) The findings were reviewed with the laboratory manager who on 04/01 /2025 at 10:25 am stated the Coplin jars contained staining materials had not been labeled with the identity, expiration date, and lot numbers. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(ii) Perform and document the function checks, including 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 -- 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, policy and procedure, and interview with the laboratory manager, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly during the review period of April 2023 through the current date. Finding include: (1) On 04/01/2025 at 10:30 am, the laboratory manager stated the laboratory performed microscopic urine sediment examination and the specimens were processed using the Drucker Diagnostics model 642-VES centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes; (2) A review of the centrifuge function check policy titled, "Instrument Maintenance & Repair" under section II required the urine centrifuge speed and time checks to be performed bi-annually at the speed of 1500 RPM + 5% for 5 minutes + 20 seconds; (3) On 04/01 /2025, a review of the centrifuge records from April 2023 through the current date identified the following: (a) Function check performed on 04/02/2024 - The centrifuge record identified speed and timer check had been reported as "Passed" - The actual speed and time that had been obtained had not been recorded. (4) The records were reviewed with the laboratory manager who stated on 04/01/2025 at 04:30 pm, the laboratory had not followed their policy for ensuring the centrifuge was functioning properly as stated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/17/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the executive director, laboratory director, and laboratory manager during an exit conference performed at the conclusion of the survey. 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, policies and procedures, and interview with the laboratory manager, the laboratory failed to follow their written function check protocol to ensure the urine centrifuge was functioning properly for two of two function checks performed during the review period of March 2022 through March 2023. Findings include: (1) On 04/17/2023 at 09:40 am, the laboratory manager stated the following: (a) The laboratory performed urine microscopic testing; (b) The urine specimens were processed at a speed of 1500 rpm (revolutions per minute) for 5 minutes using the Horizon 642 VES centrifuge. (2) A review of the policy titled, "Instrument Maintenance & Repair" under the section titled,"Centrifuge RPM Checks" stated, "Every six months we need to make sure the Centrifuges are operating at an optimal speed and time"; (3) A review of centrifuge maintenance records from March 2022 through March 2023 identified the centrifuge had not been check every 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 -- six months and identified the following: (a) 03/2023 - The timer had been checked at ten minutes instead of five minutes; (b) 03/2023 - Although the speed and timer check had been performed, there was no documentation of the actual speed and time obtained and the documentation stated, "pass". (4) The records were reviewed with the laboratory manager who stated on 04/17/2023 at 03:50 pm, the laboratory did not follow their policy and did not ensure the urine centrifuge was functioning properly as shown above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from API (American Proficiency Institute). D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report, proficiency testing Comparative Evaluation obtained from American Proficiency Institute for the third 2021 event and second 2022 event, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty 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 -- of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three consecutive testing events for Total Bilirubin. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluation obtained from American Proficiency Institute, the the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin in two of three consecutive events. Findings include: (1) The laboratory received a score of 0% on the third 2021 event and a score of 40% on the second 2022 event. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the analyte Total Bilirubin in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2021 event and the second 2022 event. Refer to D6016. 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 desk review of proficiency testing scores obtained from the Casper 0155D report and the proficiency testing graded evaluations obtained from American Proficiency Institute, the laboratory failed to achieve satisfactory performance for the -- 2 of 3 -- analyte Total Bilirubin in two of three consecutive events. The laboratory failed to achieve a passing score of 80% for the third 2021 event and the second 2022 event. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 04/12,13/2021, The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the compliance officer, laboratory director, and laboratory manager during an exit conference performed at the conclusion of the survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The recertification survey was performed 04/15/19. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory manager and the laboratory director at the conclusion of the survey. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and the laboratory director, testing persons failed to indicate the proficiency samples they tested. Findings include: (1) At the beginning of the survey, the laboratory manager 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 Sysmex XS-1000i analyzer; (2) The surveyor reviewed Hematology proficiency testing records for the First, Second, and Third 2018 Events; and the First 2019 Event. From the review, the surveyor identified 3 of the 3 testing persons (laboratory manager, testing person #3, and testing person #4) who performed the proficiency testing, had not indicated the proficiency samples they tested on the attestation statement for the Third 2018 Hematology Event; (3) The surveyor reviewed the findings with the the laboratory manager and the laboratory director, who stated to the surveyor, the 3 testing persons listed above, failed to sign the attestation statements for the proficiency testing event listed above. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) 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 -- 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 laboratory manager and the laboratory director, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records and identified the following results had not been graded by the proficiency testing program: (a) First 2018 Core Chemistry Event: (i) LDL (Low Density Lipoprotein): 1 of 5 samples had not been graded by the proficiency testing program due to no appropriate peer group being available; (aa) Sample CH-02 (i) The laboratory reported, "1;" (ii) The proficiency testing program's expected result was, "See Data Summary"; (iii) There was no evidence found in the records that the laboratory reviewed the data summary to evaluate their result. (b) First 2018 Miscellaneous Chemistry Event: (i) Urine Microalbumin: 2 of 2 samples had not been graded by the proficiency testing program due to no consensus among the participants: (aa) Sample MA-01 (i) The laboratory reported, "30 mg/L;" (ii) The proficiency testing program's expected result was, "See Data Summary"; (iii) There was no evidence found in the records that the laboratory reviewed the data summary to evaluate their result. (bb) Sample MA-02 (i) The laboratory reported, "10 mg/L;" (ii) The proficiency testing program's expected result was, "See Data Summary"; (iii) There was no evidence found in the records that the laboratory reviewed the data summary to evaluate their result. (ii) Urine Drug Screen: 1 of 1 sample had not been graded for Opiates by the proficiency testing program due to no consensus among the participants: (aa) Sample 01 (i) The laboratory reported, "Negative;" (ii) The proficiency testing program's expected result was, "See Data Summary"; (iii) There was no evidence found in the records that the laboratory reviewed the data summary to evaluate their result. (2) The surveyor asked the laboratory manager and the laboratory director if the laboratory obtained the data summary, reviewed and evaluated the proficiency testing results listed above. The laboratory manager and the laboratory director stated the non-graded results listed above had not evaluated for accuracy with the data summary. 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 manager and the laboratory director, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures. Findings include: VITROS 350 (1) At the beginning of the survey, the laboratory manager stated to the surveyor the laboratory performed Chemistry testing (i.e. Albumin, Glucose, Potassium, etc.) using the Vitros 350 analyzer; (2) The surveyor reviewed the -- 2 of 3 -- manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log and identified the following procedures were required on a weekly basis: (a) Clean tray platform and transport arm (b) Clean cup retainer (c) Clean diluent bottles (d) Clean tip locator assembly (e) Clean control unit screen (f) Clean keypad cover (g) Inspect, clean, and/or replace air filter (h) Back up QC/Config /Calibration Data (3) The surveyor reviewed the maintenance records from 08/01/17 through 3/31/19. There was no documentation found which showed the weekly maintenance procedures had been performed during 3 of 15 months reviewed: (a) Between 11/22/17 and 12/08/17 (b) Between 01/19/18 and 01/29/18 (4) The surveyor reviewed the findings with the laboratory manager and the laboratory director, who stated to the surveyor there was no documentation the manufacturer's required weekly maintenance procedures had been performed as listed above. SYSMEX XS-1000i (1) At the beginning of the survey, the laboratory manager 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 Sysmex XS-1000i analyzer; (2) The surveyor reviewed the manufacturer's maintenance requirements, as stated on the manufacturer's maintenance log and identified the manufacturer required the IPU (Internal Processor Unit) be powered down on a weekly basis; (3) The surveyor reviewed the maintenance records from 08 /01/17 through 3/31/19 and identified there was no documentation which showed the weekly maintenance procedure had been performed during 2 of 15 months reviewed: (a) Between 10/23/18 and 11/05/18 (4) The surveyor reviewed the findings with the laboratory manager and the laboratory director, who stated to the surveyor there was no documentation the manufacturer's required weekly maintenance procedure had been performed as listed above. -- 3 of 3 --