Summary:
Summary Statement of Deficiencies D0000 An unannounced complaint survey was performed on March 12, 2024, at Riverton Memorial Hospital (SageWest Lander). The laboratory was found to be out of compliance for the following condition level deficiencies: 42 C.F.R. 493.1100 Condition: Facility Administration 42 C.F.R. 493.1250 Condition: Analytic Systems D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of emergency release documentation, review of the interlaboratory variance report, review of the blood bank nightly inventory check, and interview, the laboratory failed to meet the condition of facility administration. The laboratory failed to segregate unacceptable (expired) units from the routine blood and blood product inventory to prevent the emergency release of expired units (Refer to D3021). D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on review of the emergency release documentation, review of the interlaboratory variance report, review of the blood bank nightly inventory review, and interview with technical supervisor (TS) #2, the laboratory failed to store non- expired blood and blood products separately from expired blood and blood products. Findings: 1. Review of the emergency release documentation showed one unit of packed red blood cells (pRBC) was released and issued on December 9, 2023, to patient A. Review of the emergency release form showed the unit issued to patient A on December 9, 2023, expired on December 8, 2023. 2. Review of the interlaboratory variance report confirmed that an emergency released unit that expired on December 8, 2023, was issued to patient A on December 9, 2023. 3. Review of the "Blood Bank Emergency Release Procedure" showed the laboratory failed to include instructions prohibiting the release of expired blood and blood products. 4. Review of the "Blood Product Inventory" review showed the laboratory failed to include a check of the expired blood and blood products. The "Blood Product Inventory" review was updated on December 13, 2023 to include a check of expired blood and blood products. 5. Interview with the TS #2 on March 12, 2024, at 3:00 PM confirmed the laboratory failed to segregate unacceptable (expired) units from the routine blood and blood product inventory to prevent emergency release of expired units. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of procedures, patient charts, temperature logs, blood bank emergency release forms, blood bank refrigerator alarm checks, and observation of blood bank refrigerator, the laboratory failed to meet the condition of analytic systems. The laboratory failed to have a step-by-step procedure for emergency release of blood and blood products to include instructions prohibiting the release of expired blood and blood products (Refer to D5403); the laboratory failed to define criteria for those conditions that are essential for proper storage of reagents (Refer to D5413); the laboratory failed to label the coagulation reagent with a preparation and expiration date (Refer to D5415); and the laboratory failed to perform and document quarterly alarm inspection checks for the blood bank refrigerator and plasma freezer (Refer to D5555). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, -- 2 of 5 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)