Summary:
Summary Statement of Deficiencies D0000 An unannounced onsite complaint investigation was conducted from 05/14/2024 through 05/17/2024. The allegations were substantiated and condition-level non- compliance was identified, as follows: D5026 CFR 493.1217 Condition: Immunohematology D6076 CFR 493.1441 Condition: Laboratory Director D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of policies and procedures, job aids, transfusion reaction forms, emergency release forms, laboratory information system (LIS) records, Centers for Medicare & Medicaid Services (CMS) -116 database, quality assessment forms, observation, electronic mail (email), and interview with the laboratory manager, the laboratory failed to meet the specialty of immunohematology condition as follows: 1. The laboratory failed to ensure an effective quality assessment with testing persons training when issuing incompatible plasma for one of one patient on 11/13/2023. Refer to D5293. 2. The laboratory failed to follow their own written policies and procedures when issuing plasma to one of one patient on 11/13/2023. Refer to D5401, I. 3. The laboratory failed to follow their own written procedure for ensuring documented pathology review for 6 of 11 blood product emergency releases in 2023 and 2024. Refer to D5401, II. 4. The laboratory failed to ensure the current laboratory director signed, dated, and approved the non-conforming event (NCE) policy and procedure. Refer to D5407. 5. The laboratory failed to follow their NCE policy and procedure for completing their investigation within their timeframes for one of one blood bank issue in 2023. Refer to D5791. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of