Absentee Shawnee Tribal Health System -

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/13/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and laboratory manager during an exit conference performed at the conclusion of the survey. 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 the laboratory manager, the laboratory failed to perform a negative and positive control material one of eight days of patient qualitative serum pregnancy testing. Findings include: (1) On 10/13/2022 at 09:40 am, the laboratory manager stated the following: (a) The QuPID Plus One Step hCG test kit test kit was used to perform patient qualitative pregnancy testing; (b) Negative and positive QC (quality control) materials were performed each day of patient testing. (2) A review of QC and patient testing records for testing performed from July 2021 through September 2022 revealed negative and positive QC materials had not been documented as performed each day of patient testing for one of eight days of testing. The specific day was 05/10/2022; (3) The records were reviewed with the laboratory manager who stated on 10/13/2022 at 01:45 pm, negative and positive QC materials had not been documented as performed on 05/10/2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/15/2021 The findings were reviewed with the laboratory manager/testing person #1 and the laboratory director during an exit conference performed at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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, policy and procedure manual, and interview with the laboratory manager/testing person #1, the laboratory failed to follow their written function check protocol to ensure the urine centrifuge was functioning properly for 1 of 1 years. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor: (a) The Unico (serial# 6788) centrifuge was used to process urine specimens for urine microscopic testing at a speed of 1500 rpm (Revolutions Per Minute) and a time of 10 minutes. (2) The surveyor reviewed the written centrifuge check policy (#GL17) titled, "Instrument Maintenance & Repair", which required 6 month speed checks be performed on the centrifuge; (3) The surveyor reviewed the centrifuge maintenance record for 2020. The speed had not been checked at the speed the urine specimens were processed, to ensure 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 -- centrifuge was functioning properly at that speed, for 2 of 2 checks performed as follows: (a) 02/17/2020 - The speed had been checked at 2000 rpm; (b) 06/12/2020 - The speed had been checked at 2000 rpm. (4) The surveyor reviewed the findings with the laboratory manager/testing person #1. The laboratory manager/testing person #1 stated on 01/15/2020 at 11:15 am the centrifuge speed had not been checked at the speed used to process urine specimens as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/16/18. The laboratory was found to be in compliance with standard-level deficiencies. The findings were reviewed with the laboratory director and the laboratory supervisor 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 supervisor, the laboratory failed to thoroughly review and evaluate proficiency testing results. Findings include: (1) At the beginning of the survey, the surveyor reviewed the 2017 and 2018 proficiency testing records and identified the following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program): (a) First 2017 Chemistry Event (i) Glucose: 5 of 5 results exhibited a Negative bias (aa) CET-1: SDI -2.35 (bb) CET-2: SDI -2.31 (cc) CET-3: SDI -1.05 (dd) CET-4: SDI -2.50 (ee) CET-5: SDI -2.63 (2) There was no documentation found in the records the laboratory identified the biases, investigated to determine if a systematic failure had occurred, and failed to take