Thedacare Physicians Oshkosh

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration records and interview with a technical supervisor (Staff A), the laboratory did not calibrate the Beckman Coulter DxH 520 hematology analyzer since June 2025 and failed to calibrate the analyzer every six months as required. Findings include: 1. Review of calibration records for the Beckman Coulter DxH 520 analyzer showed the laboratory calibrated the analyzer in June 2025. No records of calibration after June 2025 were available. 2. Interview with Staff A on May 6, 2026, at 12:30 PM confirmed the laboratory failed to complete calibration of the Beckman Coulter DxH 520 in December 2025 when it was due and confirmed the laboratory did not complete a calibration of the analyzer since June 2025. D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) 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 -- (e)(2) Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and This STANDARD is not met as evidenced by: Based on surveyor review of environmental condition records and interview with a technical supervisor (Staff A), the laboratory director failed to ensure the laboratory was operating within their defined humidity range during three of three months reviewed. Findings include: 1. Review of humidity documentation from December 2025 through February 2026 showed the laboratory's acceptable humidity range was 20-60% relative humidity. The records showed the recorded relative humidity was below 20% on 31 of 31 days in December 2025, 30 of 31 days in January 2026, and 28 of 28 days in February 2026. 2. Interview with Staff A on May 6, 2026, at 1:30 PM confirmed the humidity was not in the acceptable range from December 1, 2025, through February 28, 2026, except for one day, showing the director did not ensure the laboratory could maintain relative humidity levels within the defined acceptable range for testing. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory competence assessment records and interview with a technical supervisor (Staff A), the laboratory did not document competence evaluations of seven of seven testing personnel in performing high complexity white blood cell (WBC) differentials in 2025 or 2026. Findings include: 1. Review of competence assessment records showed no evidence technical supervisors evaluated testing personnel to ensure competent performance of high complexity WBC differentials in 2025 or 2026. 2. Interview with Staff A on May 6, 2026, at 9:50 AM revealed the laboratory did not evaluate testing personnel competence in performing high complexity WBC differentials at this location. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on surveyor review of laboratory procedures, observation of hematology quality control (QC) material and interview with testing personnel, staff A, and technical consultant, testing personnel did not label three of three opened QC vials with the opened date and open expiration date. Findings include: 1. Review of the "DxH 520 Quality Control" procedure stated under the "Quality Control" header "Open stability: 16 days". 2. Observation of the hematology QC in the laboratory refrigerator on April 30, 2024, at 12:15 PM revealed three vials of hematology quality control, Lot# 362415811, 362415812, and 362415813. Further observation of the vials showed no opened date and no revised expiration date on the vials. 3. Interview with staff on April 30, 2024, at 12: 20 PM confirmed the hematology QC expiration date changes when the vials are opened. Interview with the technical consultant on April 30, 2024, at 12:20 PM confirmed testing personnel did not label the QC vials with the opened date and expiration date after they were opened. 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 D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records, procedures, and the laboratory information system (LIS) and interview with testing personnel and a technical consultant, testing personnel did not document all Quality Control (QC) activities and