Ellinwood District Hospital

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interview, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. Findings: 1. Review of the laboratory's 2026 API PT documentation found the laboratory was testing API PT samples multiple times. One sample was analyzed for 6 regulated analytes of the Complete Blood Count (CBC): Red Bloodcell Count (RBC), Hemoglobin, Hematocrit, Platelet, White Bloodcell Count (WBC), and WBC auto differential. 2. The sample XE-02 from API Event 1, was tested two times. 3. The laboratory policy, Proficiency Testing Policy Prohibitions Regarding PT Samples states "Proficiency testing specimens must be handled in the same manner, to the extent practicable, as are patient specimens. 'For example, if the proficiency specimen result is within your critical range, and you have a written policy that you would repeat a patient specimen in this range, then repeat the proficiency specimen. If you would not repeat a patient specimen, do not repeat testing on the proficiency specimen." 4. No documentation for the reason of the repeated testing was provided at survey. The general supervisor #1 (GS#1) response was she was unaware running a PT sample multiple times was not allowed per CMS PT program and laboratory's policy . 5. Interview with GS#1 on 9/17/26 at 9:30 a.m. confirmed, the laboratory failed to test proficiency samples the same number of times that it routinely tests patient samples. 55063 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (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 the blood bank refrigerator alarm check records performed on 8/19/24 and interview with general supervisor (GS) #1, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. Findings: 1. Review of monitoring records found a 24 hour monitoring system was in place with paper graphs for temperature records. 2. The hospital, including the laboratory, relocated to a new building on 7/8/24. Review of Hi/Lo alarm check records performed on 8/19/24 revealed the secondary monitoring process (laboratory was not staffed 24 hours a day, 7 days a week) was nonfunctional for the secondary notification to the nursing station. 3. Review of patient records found no patient received blood products from 7/8/24 to the date of survey. 4. Interview with the GS #1on 8/21/24 at 12:03 p.m. confirmed, the laboratory failed to maintain an adequate temperature alarm system for the storage of blood products. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --