Osborne County Memorial Hospital

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of "Proficiency Test handling and Result Submission" procedure, the lack of secondary review documentation, lack of

Summary Statement of Deficiencies D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the review of Immunohematology Post Transfusion Reaction reports, compatability review forms and interview, the laboratory failed to document any optional testing and the pathologist interpretation on 2 of 2 post transfusion reaction patient reports. Findings: 1. Review of 2 of 2 Blood Bank Compatility Review forms revealed the signature and date of the Technical Supervisor (TS) for unit W200920353373 and an interpretive comment, signature and date of TS for unit W200920332317. 2. Review of 2 of 2 Post Transfusion Reaction Reports for the same patient who received the 2 units reveals both reports listed postive Direct Antibody Test (DAT) results for both the pre-transfusion and post-transfusion specimens tested (listed as step 3 on the form). 3. The form states: "If any results in steps 2, 3, or 4 are positive, continue with optional testing ordered by the pathologist. 4. No optional testing reference was present on 2 of 2 patient report forms. 5. No interpretive comment by the pathologist was present on 2 of 2 patient report forms. 6. The signature and date of the TS was present on both patient report forms. 7. The General Supervisor (GS) #1 stated the Blood Bank Compatability Review form was not a 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 -- patient test report and was not placed into the patient's EMR. The documents labeled as Post Transfusion Reaction Reports are used as the patient test report. 8. Interview with GS #1 on 19 April, 2021 at 3:45 p.m. confirmed, the laboratory failed to document any optional testing and the pathologist interpretation on 2 of 2 post transfusion reaction patient reports. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Review of the Sysmex Ca600 Normal Patient Mean records for 2017 and 2018 and interview with General Supervisor #1 (laboratory personnel report CMS-209), the laboratory failed to retain the documentation of the normal patient mean assay sheets for the required two year period. Findings were: a.. At the time of the survey July 31, 2018 the laboratory failed to produce the documentation of the Normal Patient Mean studies for 2017 for the CA600 Coagulation analyzer , this was confirmed in interview with General Supervisor #1 July 31, 2016 at 10:00 hrs D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: A review of Coagulation Quality Control and reagents log .revealed the laboratory 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 -- failed to log the the lot numbers of the current lot of reagent and Quality Control in use Findings were: a. The above findings were confirmed by interview with the general supervisor on 7/31/2018 at 13:50 hours in the laboratory. D5783