Absentee Shawnee Tribal Health System -

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/06/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and testing person #2 at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, a review of records, and interview with testing person #2, the laboratory failed to ensure Vacutainer brand tubes were stored as required by the manufacturer for three of three months reviewed. Findings include: (1) Observation of the laboratory on 09/06/2023 at 11:00 am, identified multiple BD Vacutainer tubes stored in the the laboratory with a manufacturer's storage requirement of 4-25 degrees Celsius; (2) A review of temperature logs for three months showed the acceptable temperature range defined as 18-28 degrees Celsius. In addition, temperatures had been documented as warmer than 25 degrees Celsius for three of three months as follows; (i) June 2023 - two of 30 days (ii) July 2023 - nine of 31 days (iii) August 2023 - eight of 31 days (3) Interview with testing person # 2 on 09/06/2023 at 11:00 am confirmed the acceptable temperature range allowed for temperatures warmer than 25 degrees Celsius and the Vacutainer tubes had not been stored as required by the manufacturer. 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 initial survey was performed on 10/12/2021. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director and laboratory supervisor at the conclusion of the survey. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the procedure manual and interview with the laboratory supervisor, the laboratory failed to ensure written policies and procedures had been approved, signed, and dated by the laboratory director. Findings include: (1) On 10/12 /2021 at 09:45 am, the laboratory supervisor stated to the surveyor the laboratory began performing the following testing on 07/06/2020: (a) Urine Microscopic testing (b) Wet Prep Analysis (2) The survey reviewed the manual titled, "Plus Care Policies", which contained written policies and procedures. There was no indication the manual had been approved, signed, and dated by the laboratory director; (3) The surveyor showed the manual to the laboratory supervisor who stated on 10/12/2021 at 10:56 am, the manual contained the policies and procedures and had not been signed and dated by the laboratory director. 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 --