Rural Health Services Consortium, Inc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and Wisconsin State Laboratory of Hygiene (WSLH) 2024 and 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit analyte. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH proficiency testing 2024 and 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Hematology for the Hematocrit analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2024-3rd Event: The laboratory received an unsatisfactory score of 60% for the Hematocrit analyte. Hematology 2025-1st Event: The laboratory received an unsatisfactory score of 60% for the Hematocrit analyte. 2. A review of the WSLH proficiency testing records confirmed the laboratory received the above results. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and WSLH 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 proficiency testing desk review of the CASPER 0155 report and WSLH proficiency 2024 and 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130. -- 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 a review of the laboratory's Proficiency Testing (PT) records and staff interview, the laboratory failed to review performance evaluations for PT in 2023. The findings include: 1. A review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) PT records revealed the performance evaluations for 2023 Events One, Two, and Three did not have documented reviews performed by the laboratory director. 2. An interview with the lead testing person on 06.18.2024 at 11:15 a.m. confirmed that the laboratory failed to document a review of the performance evaluations for PT Events One, Two, and Three in 2023. 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 observation of the laboratory, review of the laboratory's policy, random review of patient test records from 05.20.2024, 05.21.2024, and 06.03.2024, and interview with the lead testing person, the laboratory failed to follow their Abnormal WBC Differential Counts Instrument Flag policy in May 2024. The findings include: 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 -- 1. Observation of the laboratory on 06.18.2024 at 9:30 a.m. revealed a Beckman Coulter DXH-520 (serial number BG060285) hematology analyzer used for CBC patient testing. 2. A review of the laboratory's Abnormal WBC Differential Counts Instrument Flags policy revealed, "When the analyzer flags a result, the CBC will be rerun to verify the flag." 3. A random review of patient test reports from the Beckman Coulter DXH-520 hematology analyzer from 05.20.2024, 05.21.2024, and 06.03.2024 revealed one of ten results with the following CBC flag: -Date 05.20.2024; Patient 86855; Flag PLT3: PLT/RBC Overlap: no documentation of sample rerun 4. An interview with the lead testing person on 06.18.2024 at 12:10 p.m. confirmed that the laboratory failed to follow the Abnormal WBC Differential Counts Instrument Flags policy when one of ten patients' CBC results was flagged with no documentation of a sample rerun on 05.20.2024. Word Key: Complete Blood Count = CBC White Blood Cell = WBC Platelet = PLT Red Blood Cell = RBC D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare and Medicaid Services (CMS) 209 form, testing personnel (TP) records, and staff interview, the technical consultant failed to perform interim competency during the first year of testing for one of one new testing personnel in 2023. The findings include: 1. Observation of the laboratory on 06.18.2024 at 9:30 a.m. revealed a Beckman Coulter DXH-520 (serial number BG060285) hematology analyzer used for Complete Blood Count (CBC) patient testing. 2. A review of form CMS-209 revealed one new testing personnel listed since the last survey, who perform moderately complex patient testing for CBC. 3. A review of testing personnel records revealed no documentation of interim competency for testing personnel number three (TP-3) during TP-3's first year of patient testing for CBC in 2023. 4. An interview with the technical consultant on 06.18.2024 at 11:10 a.m. confirmed the above survey findings. -- 2 of 2 --