Gundersen Health System Viroqua Clinic

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 review of laboratory records, observation of reagents, and interview with a testing personnel, staff A, the laboratory used expired Wright- Giemsa stain solution, Hema-Quik II, to stain slides used for hematology slide scans and manual differentials for two of ten months in 2025. Findings include: 1. Review of the "Hema-quik II Stain Log" revealed the log was specific to one lot number of stain solution and showed the laboratory used the log to record dates when they poured off Hema-Quik II stain from the original bottle into a Coplin jar for use. The log for lot number 144252, with manufacturer's expiration date of August 31, 2025, contained five entries where the laboratory recorded pouring off stain solution after the expiration date: September 3, 2025, September 22, 2025, October 8, 2025, October 21, 2025, and November 7, 2025. 2. Observation in the laboratory on November 14, 2025, at 2:15 PM revealed only one bottle of Hema-Quik II stain, lot number 151237, manufacturer's expiration date January 1, 2026, with an open date of November 7, 2025. 3. Interview with staff A on November 14, 2025, at 2:15 PM confirmed the in-use bottle of Hema-Quik II stain was opened on November 7, 2025, and that the laboratory had used the "Hema-quik II Stain Log" for the previous bottle, lot number 144252, to record the pour off date for the new bottle, lot number 151237 on November 7, 2025. On further interview, staff A confirmed the laboratory used expired Hema-Quik II stain solution to stain slides for hematology slide scans and manual differentials between the time when the bottle with lot number 144252 expired on August 31, 2025, and the start of a new lot on November 7, 2025. 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 D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of competence evaluation records and procedures and interview with the Laboratory Director, the laboratory did not establish and follow written policies and procedures to assess the competence of one of one clinical consultant. Findings include: 1. Review of competence evaluation records showed no evidence the laboratory director evaluated the competence of a clinical consultant. 2. Review of the procedure, 'Quality Assurance for Laboratory Testing, Lab 0135', that included competence assessment policies, showed no evidence of a process for evaluation of the competence of the clinical consultant in performing their responsibilities. 3. Interview with the Laboratory Director on May 16, 2024, at 9:40 AM confirmed the laboratory had not established procedures to evaluate employee competence in performing the clinical consultant responsibilities. Further interview confirmed the director had delegated the clinical consultant responsibilities to Staff A and confirmed the director had not evaluated competence of Staff A in performing their delegated responsibilities. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and procedures and interview with the laboratory director, the laboratory did not document the initiation date for one of one new test system with the procedure. The 'Sysmex XN-450/XN-550 Complete Blood Count and Parameters - Whole Blood, Lab -1532' procedure showed no initiation date for this laboratory. Findings include: 1. Review of laboratory records showed the laboratory verified performance specifications for the Sysmex XN-550 analyzer in February 2024. 2. Review of the procedure, 'Sysmex XN-450/XN-550 Complete Blood Count and Parameters - Whole Blood, Lab -1532', showed no indication of the initial date of use for the Sysmex XN-550 analyzer in this laboratory. 3. Interview with the laboratory director on May 16, 2024, at 10:00 AM confirmed the procedure did not include the initial date of use for the Sysmex XN-550 at this laboratory. -- 2 of 2 --