Bellin Health Marinette Laboratory

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of Individualized Quality Control Plan (IQCP) documents and interview with the laboratory team facilitator, the laboratory director did not ensure completion of the quality assessment evaluation of the IQCP for the Triage analyzer in one of the last two years. Findings include: 1. Review of IQCP documentation for the Triage analyzer revealed a quality assessment evaluation for the Triage IQCP from 2021. No records were available showing the laboratory completed a quality assessment of the Triage analyzer IQCP in 2022. 2. Interview with the laboratory team facilitator (staff A) on September 26, 2023, at 1:30 PM confirmed the director did not ensure completion of the quality assurance evaluation of the IQCP for the Triage analyzer in 2022. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of reagents used in the laboratory, testing worksheet review and interview with the Laboratory Supervisor, the laboratory used KOH (potassium hydroxide) reagent past the reagent expiration date. Findings include: 1. Surveyor observation October 28, 2019, at 2:45 PM, showed the KOH reagent, Lot #1828809, available for use in the laboratory, expired on October 15, 2019. 2. Review of KOH testing worksheets showed 7 patients had KOH testing performed between October 16, 2019 and October 28, 2019. 3. Interview with Staff A, October 28, 2019 at 2:45 PM, confirmed the laboratory reagent used the KOH past the manufacturer's expiration date. 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 --