Koweta Indian Health Facility

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/18,19/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #3 at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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, policies and procedures, and interview with technical consultant #3, the laboratory failed to follow their written policy for establishing the means for new lot numbers of control materials prior to implementation for nine of 15 lot numbers used during the review period of 11/15/2023 through 06/28/2024. Findings include: (1) On 07/18/2024 at 08:35 am, technical consultant #3 stated the following: (a) The laboratory performed CBC (complete blood count) testing using the Abbott Cell-Dyn Ruby analyzer; (b) Three levels of Cell-Dyn 26 Plus Control QC (quality control) materials were performed each day of patient testing. (c) Laboratory established means and historic SD's (standard deviations) were used to determine acceptability of quality control results. (2) A review of the procedure manual titled, "Complete Blood Count Abbott Cell-Dyn Ruby" on page 4, under the section "X. Quality Control" stated the following: (a) "F. Run the new controls twice a day for 5 days." (3) A review of records for 15 control lot numbers used from 11/15/2023 through 06/28/2024 identified the laboratory did not follow their policy as follows: (a) Lot #L3303, Lot #N3303, and Lot #H3303 - The controls had been tested thirteen times over three days as follows: (i) Four times on 11/15/2023 (ii) Four times on 11/16 /2023 (iii) Five times on 11/17/2023 (b) Lot #L3359, Lot #N3359, and Lot #H3359 - 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 controls had been tested ten times over one day as follows: (i) Ten times on 01/12 /2024 (c) Lot #N4106 - The control had been tested thirteen times over two days as follows: (i) Twice on 04/30/2024 (ii) Eleven times on 05/01/2024 (d) Lot #N4106, and Lot #H4106 - The controls had been tested twenty times over four days as follows: (i) Five times on 04/30/2024 (ii) Fifteen times on 05/01/2024 (4) The findings were reviewed with technical consultant #3 who stated on 07/19/2024 at 10: 00 am, the laboratory did not follow their written policy. 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 technical consultant #3, the laboratory failed to follow their written protocol for ensuring the urine centrifuge was functioning properly for one of two annual function checks performed during the review period of June 2022 through the current date. Finding include: (1) On 07/18/2024 at 11:00 am, technical consultant #3 stated the following: (a) Urine sediment examinations were performed by the laboratory; (b) The specimens were processed in a Unico centrifuge at a speed of 1500 rpm (revolutions per minute) for 5 minutes. (2) A review of the procedure titled, " Microscopic Urine Analysis", stated "Place 10 to 12 milliliters (ml) of a well mixed urine into a labeled urine tube. Cap the tube and place it in the centrifuge for 5 minutes at 1500 revolutions per minute (RPM)"; (3) A review of centrifuge function check records from June 2022 through the current date identified on 04/03/2024 the centrifuge speed been checked at 2000 (RPM's), rather than 1500 (RPM's); (4) The records were reviewed with technical consultant #3, who stated on 07/18/2024 at 11:00 am, the laboratory had not followed their policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/16/2022. The findings were reviewed with the laboratory consultant and technical consultant #2 at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. 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 and interview with the laboratory consultant, the laboratory failed to following the manufacturer's instructions for specimen transport and storage for four of four patient specimens. Findings include: (1) On 05/16/2022 at 11:00 am, the laboratory consultant stated: (a) The laboratory performed COVID-19 testing using the following instrument (i) Abbott BinaxNOW COVID-19 Ag Card - qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swabs. (2) A review of the manufacturer's product insert titled, "BinaxNOW COVID-19 Ag" under the section titled, "TEST PROCEDURE", which stated: (a) "4. Peel of adhesive liner from the right edge of the test card. Close and securely seal the card. Read result in the window 15 minutes after closing the card. In order to ensure proper test performance, it is important to read the result promptly at 15 minutes, and not before. Results should not be read after 30 minutes." (3) A review of four test reports for patients tested on 05/11/2022, 05/12/2022, 05/13/2022 and 05 /16/2022 identified the following: (a) Patient Report #4004153415 - Specimen collection date and time (05/11/2022 at 02:01 pm) and the result date and time (05/11 /2022 at 02:05 pm), four minutes later; (b) Patient Report #4004245892 - Specimen collection date and time (05/12/2022 at 04:15 pm) and the result date and time (05/12 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 -- /2022 at 04:19 pm), four minutes later; (c) Patient Report #4003818605 - Specimen collection date and time (05/13/2022 at 02:22 pm) and the result date and time (05/13 /2022 at 02:23 pm), one minute later; (d) Patient Report #4002185786 - Specimen collection date and time (05/16/2022 at 11:09 am) and the result date and time (05/16 /2022 at 11:10 am), one minute later; (4) The records were reviewed with the laboratory consultant. The laboratory consultant stated on 05/16/2022 at 12:05 pm the laboratory could not prove the results had been interpreted according to manufacturer's instructions as indicated above. 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 the laboratory consultant, the laboratory failed to evaluate the accuracy of testing when proficiency results had not been graded by the proficiency program for one of 18 proficiency testing events reviewed. Findings include: (1) On 05/16/2022, a review of 2021 and 2022 proficiency testing records revealed the following for one of 18 testing events: (a) Second 2021 Hematology Event for Blood Cell Identification - one of five results had not been graded by the proficiency testing program: (i) For the result (BCI-07), the following was identified: (aa) BCI-07 - Under "Expected Results" it stated, "See Data Summary". There was no evidence the laboratory reviewed the commentary contained in the "Participant Summary Report" to evaluate their result. (2) The records were reviewed with the laboratory consultant who stated on 05/16/2022 at 12:52 pm, the laboratory had not documented the review of the non-graded result 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 consultant, 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 one of 18 events. Findings include: (1) On 05/16/2022, a review of 2021 and 2022 proficiency testing events revealed for one of 18 events, the attestation statements had been signed approximately two 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) Third 2021 -- 2 of 3 -- Hematology Event - The sample testing had been completed on 11/12/2021 and the attestation statement had not been signed by the laboratory director/designee until 01 /19/2022. (2) The findings were reviewed with the laboratory consultant who stated on 05/16/2022 at 01:25 pm the attestation had been signed approximately two months after the proficiency samples had been tested. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 10/20/2020. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with technical consultant #2 and testing person #2 at the conclusion of the survey. 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 technical consultant #2, the laboratory director or designee and testing person failed to sign a proficiency testing attestation statement for 1 of 13 events. Findings include: (1) The surveyor reviewed 2019 and 2020 proficiency testing records and identified the following for 1 of 13 events: (a) First 2020 Chemistry Miscellaneous Event - The attestation statement had not been signed by the laboratory director or designee and by the person performing the test. (2) The surveyor reviewed the findings with technical consultant #2, who stated to the surveyor on 10/20/2020 at 11:55 am, the attestation statement had not been signed by the laboratory director or designee and the person performing the test. D5435 MAINTENANCE AND FUNCTION CHECKS 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 -- 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 technical consultant #2, the laboratory failed to ensure the urine centrifuge was functioning properly for 1 of 5 function checks. Findings include: (1) On 10/20/2020 at 09:30 am, technical consultant #2 stated the following to the surveyor: (a) Urine sediment examinations were performed in the laboratory; (b) The specimens were processed in the Unico Centrifuge (denoted by the laboratory as #78896) at a speed of 1500 rpm (revolutions per minute) for 5 minutes. (2) The surveyor reviewed the policy titled, "Maintenance and Function Checks", which stated, "Function checks for RPM and accuracy are performed by the MCNDH Net Facilities Department twice a year"; (3) The surveyor reviewed the centrifuge maintenance records for 2019 and to date in 2020. The speed had not been checked at the speed the urine specimens were processed, to ensure the centrifuge was functioning properly at that speed, for 1 of 5 checks performed as follows: (a) 09/03/2020 - The speed had been checked at 3916 rpm. (4) The surveyor reviewed the findings with technical consultant #2, who stated on 10/20/2020 at 12:42 pm, the centrifuge speed had not been checked at the speed used to process urine specimens. -- 2 of 2 --