Flandreau Santee Sioux Tribal Clinic

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 12/5/23. Flandreau Santee Sioux Tribal Clinic laboratory was found not in compliance with the following requirements: D2015. 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 record review and interview, the laboratory failed to maintain a copy of required documentation related to the processing of 17 of 17 proficiency testing (PT) events reviewed (2022 Chemistry Core 1st, 2nd, and 3rd events; 2022 Immunology /Immunohematology 1st, 2nd, and 3rd events; 2022 Hematology/Coagulation 1st, 2nd, and 3rd events; 2023 Chemistry Core 1st, 2nd, and 3rd events; 2023 Immunology /Immunohematology 1st and 2nd events; 2023 Hematology/Coagulation 1st, 2nd, and 3rd events). That documentation would ensure the results submitted for evaluation had been the results submitted by the laboratory processing the PT samples. Findings Include: 1. Review on 12/5/23 of the laboratory's 2022 and 2023 American Proficiency Institute (API) PT event records revealed: *The laboratory subscribed to PT events through API. *PT specimens were processed, and the results submitted 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 -- electronically via the company's website upon completion of testing. *The laboratory had the ability to print a copy of the final PT results submitted for evaluation. *The laboratory had not retained copies of final electronically submitted results for evaluation for the following events: -2022 API Chemistry Core 1st, 2nd, and 3rd testing events. -2022 API Immunology/Immunohematology 1st, 2nd, and 3rd testing events. -2022 API Hematology/Coagulation 1st, 2nd, and 3rd testing events. -2023 API Chemistry Core 1st, 2nd, and 3rd events. -2023 API Immunology /Immunohematology 1st and 2nd events. -2023 Hematology/Coagulation 1st, 2nd, and 3rd events. Interview on 12/5/23 at 10:45 a.m. with the laboratory supervisor revealed she confirmed: *PT results were submitted electronically after PT samples had been processed. *The laboratory had not printed copies of all final submitted results. Review of the laboratory's PT policy, effective 12/8/21 revealed: *If results were submitted electronically, a copy of the submitted results should be retained. *All PT records that are kept are to be made available for inspection by the surveyor. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey for compliance with 42 CFR Part 493, Requirements for Laboratories, was conducted on 4/21/22. The Flandreau Santee Sioux Tribal Clinic laboratory was found not in compliance with the following requirements: D5209 and D6028. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the review of laboratory records and interview the laboratory failed to establish written policies and procedures to assess the competency of testing personnel to perform preanalytical, analytical and post-analytical tasks in 2020, 2021, and to the date of the survey on 4/21/22. Findings include: 1. Review of the laboratory records revealed competency assessments had been performed for testing personnel in 2020 and 2021. A copy of the laboratory's competency assessment policy was requested on 4/21/22 at 11:20 a.m. The laboratory staff was unable to provide a copy of this policy. Interview on 4/21/22 at 11:20 a.m. with laboratory personnel A revealed: *She did not think the laboratory had a written procedure for competency assessment. *She was not aware the laboratory needed to have a written policy as the competency assessments had been completed on a yearly basis. The laboratory director was unavailable for interview at the time of the survey. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) The laboratory director is responsible for the overall operation and administration of 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 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure competency evaluations for one of two laboratory staff (B) were completed by qualified personnel (their credentials had not been reviewed to determine if they were qualified to serve as technical consultants) for the nonwaived test methods they had been performing under the laboratory's certificate. Findings include: 1. Review of the employee's file for laboratory staff B revealed her competency assessments were completed on 10/1/20, 3/18/21, and 9/12/21 had been performed by laboratory staff A. There was no indication the laboratory director was involved in the competency assessment process nor had he dated the evaluations. Review of the CMS 209 Laboratory Personnel Report Form signed by the laboratory director on 4/19/22 revealed the laboratory director was also serving as the technical consultant. Laboratory staff A and B were listed only as testing personnel and not listed as technical consultants. A copy of the laboratory's competency assessment policy was requested on 4/21/22 at 11:20 a.m. Laboratory staff A was unable to provide the requested copy. She did not think the laboratory had a competency assessment policy. Interview on 4/21/22 at 11:20 a.m. with laboratory staff A revealed: *She confirmed she had completed laboratory staff B's competency assessments. *She had an associate degree in medical technology. *She was not aware she did not qualify under the CLIA regulations as a technical consultant. The laboratory director was unavailable for interview at the time of the survey. -- 2 of 2 --