Kingdom Pathways

Summary Statement of Deficiencies D0000 . The Kingdom Pathways laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on April 8, 2024. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance 493.1413 Technical consultant responsibilities . 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 document review and interview with laboratory personnel, the laboratory failed to review proficiency testing (PT) results for three of four PT events completed in 2023 and 2024. Findings are as follows: 1. The laboratory performed ethyl alcohol and cannabinoid testing under the Toxicology subspecialty as confirmed by the Technical Consultant and Laboratory Director (LD) during a tour of the laboratory at 10:05 a.m. on 04/08/25. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. Laboratory director review of proficiency testing scores was required when each event was graded by API as established in the Proficiency Testing procedure found in the Proficiency Testing manual. 4. The results from the following PT events were not found in the laboratory records on the day of survey. 2023 1st Chemistry miscellaneous event 2023 2nd Chemistry miscellaneous event 2024 1st Chemistry miscellaneous event The laboratory was unable to provide evidence of documented PT result review for these events upon request. 5. In an interview at 11:10 a.m. on 04/08/25, the LD confirmed the above findings. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Consultant failed to assess Toxicology testing competency at least annually for one of two testing personnel (TP) in 2023 and one of three TP in 2024. Findings are as follows: 1. The laboratory performed ethyl alcohol and cannabinoid testing under the Toxicology subspecialty as confirmed by the Technical Consultant (TC) and Laboratory Director during a tour of the laboratory at 10:05 a.m. on 04/08 /25. 2. A Mindray BS-200 chemistry analyzer and a ThermoFisher Scientific Indiko Plus chemistry analyzer were observed in the laboratory during the tour. The laboratory performed testing on the Indiko Plus analyzer beginning in June 2024. The Mindray analyzer was in use prior to June 2024. 3. Ethyl alcohol and cannabinoid testing competency assessments were required annually as established in the Employee Training Competency and Assessment procedure found in the Safety & Employee Policies Manual. 4. Annual competency assessment documentation for the following TP was not found during review of laboratory records as indicated below. 2023 TP1 2024 TC 5. The laboratory was unable to provide the missing records upon request. 6. In an interview at 10:30 am. on 04/08/25, the TC confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies 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 document review and interview with laboratory personnel, the laboratory failed to investigate one unacceptable Chemistry proficiency testing (PT) results out of twelve challenges completed in 2022. Findings are as follows: 1. The laboratory performed Chemistry (Toxicology) testing as confirmed by the Technical Consultant during a tour of the laboratory at 10:05 a.m. on 12/20/22. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory received one unacceptable PT result of twelve Opiate testing challenges completed in 2022 as indicated in API reports. See below. 2022 Chemistry - Miscellaneous - 1st event Test: Opiates Sample: UDS-02 Laboratory Result: Negative API expected range: Positive 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing procedure located in the Proficiency testing manual. 5. Investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 10:40 a.m. on 12/20/22, the Laboratory Director confirmed the above finding. . 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 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 observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document function checks (calibration) for 3 of 3 digital thermometers. Findings are as follows: 1. The laboratory performed Toxicology testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory on 12/31/20, at 09:05 a.m. 2. The following digital thermometers were observed as in use in the laboratory refrigerators during the tour: Serial #: 181559379 Calibration Expiration Date: 8-30-20 Refrigerator: Sample Storage Serial #: 181616154 Calibration Expiration Date: 9-26-20 Refrigerator: Reagent Storage 1 Serial #: 181559380 Calibration Expiration Date: 8-30-20 Refrigerator: Reagent Storage 2 3. The manufacturer's certificate of calibration for each thermometer was not found in the laboratory's records. Documentation of function checks for this equipment was not found in laboratory records. The laboratory was unable to provide certificate of calibration or function check documentation for the thermometers upon request. 4. In an interview on 12/31/20, at 9:55 a.m., the LD confirmed the above finding. NOTE: This is a repeat citation from previous survey, 10-30-18. . 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 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 observation, document review and interview with laboratory personnel, the laboratory failed to establish a function check procedure and perform functions checks on all ancillary laboratory equipment. Findings are as follows: 1. One digital thermometer and two dial thermometers were observed in use in laboratory refrigerators during a tour the laboratory on 10/30/18 at 1:00 p..m. Manufacturer calibration labels were not present on the thermometers. 2. Laboratory refrigerators contained patient specimens, testing reagents and quality control materials. 3. A function check procedure for the thermometers was not found in the laboratory's established procedure manuals. Documentation of function checks for this equipment was not found in laboratory records. The laboratory was unable to provide a function check procedure or documentation of function checks for the thermometers upon request. 4. In an interview on 10/16/18, at 1:55 p.m., the General Supervisor confirmed the above finding. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) 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 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to perform and document calibrations for Chemistry (Toxicology) testing with the frequency established by the laboratory. Findings are as follows: 1. The laboratory performed Chemistry (Toxicology) testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 10/30/18 at 1:00 p.m. 2. A Mindray BS 200 chemistry analyzer was observed as present and available for use during the tour of the laboratory. Analytes tested on this analyzer were as follows: cannabinoids and alcohol. 3. The Kingdom Pathways Operations Manual procedure located in the Laboratory Procedure Manual established calibration performance frequency for the analytes as every 2 weeks. The LD approved the procedure on 12/13 /17. 4. The laboratory exceeded the 2 week calibration interval (Cal.)on one occasion in the time period reviewed; May 2017 through October 2018. See below Previous Cal. Subsequent Cal. Elapsed time 05/03/17 07/10/17 2 months, 7 days 5. Laboratory records indicated 211 patient specimens were tested between 05/18/17 and 07/10/17. 6. In an interview on 10/30/18 at 3:30 p.m., the GS confirmed the above finding. **This is a repeat finding from the 05/17/17 survey** -- 2 of 2 --