Uw Health Central Laboratory

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 and interview with a technical consultant, staff A, the laboratory used expired reagents to perform potassium hydroxide (KOH) testing for three of three patient tests between February 2-12, 2025. Findings include: 1. Review of laboratory records showed KOH Lot 240806-020 expired on February 2, 2025, and KOH Lot 241227-038 was opened on February 12, 2025. 2. Review of patient testing in the laboratory information system (LIS) showed three KOH patient tests had been performed between February 2, 2025, and February 12, 2025. 3. Interview with staff A on March 27, 2025, at 1:00 PM confirmed the laboratory used expired reagents to perform KOH testing. This is a repeat deficiency from August 1, 2023. 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 review of laboratory records and interview with a technical consultant, the laboratory records for three of three reagents used from 2021 - 2023 showed either expired reagents were in use in 2022 and 2023 or the record was not readable. Findings include: 1. Review of the 'Liquid Chemical Log' from the UW Health Dermatology laboratory showed the laboratory tracked reagents on the log starting in 2018. The log included (in part) the reagent name, lot number, expiration date, and the opened date. Reagents tracked on the log included Chlorazol Fungal Stain, 20% KOH (potassium hydroxide), and Toluidine Blue Solution. Personnel added Light Mineral Oil to the log in 2023. The log included the following records: Lot number / opened date / expiration date Chlorazol Fungal Stain: 0002 / June 7, 2021 / January 2, 2022 K22985 / April 24, 2023 / September 30, 2023 20% KOH liquid: K196K4 / September 2, 2021 / unreadable K22C63 / March 22, 2023 / December 31, 2025 Toluidine Blue Solution: K198T2 / January 19, 2021/September 30, 2021 K229E6 / June 29, 2023 / September 30, 2024 2. Interview with a technical consultant (staff A) on August 1, 2023, at 10:15 AM confirmed the laboratory's documentation did not show testing personnel used in-date reagents for testing during 2022 through March, April or June 2023 and confirmed testing personnel performed patient testing that required use of the reagents during that time. 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 D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on surveyor review of calibration verification records and interview with the general supervisor, the laboratory did not perform calibration verification every six months for the Abbott Architect chemistry and immunoassay analyzers in 2020 and 2021. Findings include: 1. Review of calibration verification records showed calibration verification performed in July 2019, July 2020, April 2021 and July 2021 for all required analytes. Further review showed no additional documentation of 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 -- calibration verification for the Abbott Architect chemistry and immunoassay analyzers in 2020 and 2021. 2. Interview with the general supervisor on September 22, 2021 at 2:58 PM confirmed the laboratory did not perform calibration verification every six months for the Abbott Architect chemistry and immunoassay analyzers in 2020 and 2021. This is a repeat deficiency from August 7, 2013 and July 14, 2015. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant of coagulation testing, the laboratory did not have a procedure available for the new Instrumentation Laboratory ACL TOP 300 CTS coagulation analyzer. Findings include: 1. The laboratory replaced the Sysmex CA 1500 coagulation analyzer with the Instrumentation Laboratory ACL TOP 300 CTS coagulation analyzer effective March 26, 2018. Protime, activated partial thromboplastin time (aPTT), and D-Dimer testing is performed on the new coagulation analyzer. 2. Review of the laboratory procedures show no evidence of an approved procedure available for staff for the new coagulation analyzer. 3. Interview with the technical consultant on June 12, 2019 confirmed that a procedure has not been completed and approved by the laboratory director for coagulation testing performed on the new coagulation analyzer. 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). This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on surveyor review of procedures and interview with the technical supervisor, the laboratory has not documented the date of discontinuance for the Cobas Chlamydia Trachomatis (CT)/Neisseria Gonorrhea (GC), Anti nDNA, and the Sysmex CA 1500 Coagulation procedures. Findings include: 1. Review of the Cobas CT/GC, Anti nDNA, and Sysmex CA 1500 Coagulation procedures show that a discontinuance date has not been documented on the procedures. 2. Interview with the technical supervisor on June 12, 2019 at 12:45 PM confirmed that testing on the new coagulation analyzer was effective March 26, 2018 but the procedure for the previous coagulation analyzer (Sysmex CA 1500) was the current procedure available for staff use and the date of discontinuance was not documented on the procedure. 4. Further interview with the technical supervisor at 1:30 PM confirmed that Cobas CT/GC testing was possibly discontinued June 22, 2018 but the date of discontinuance was not documented on the procedure. The technical supervisor also confirmed that the Anti nDNA procedure was discontinued in "early 2018" but the date of discontinuance was not documented on the procedure. This is a repeat deficiency previously cited on July 14, 2015. D6055 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of training and competency evaluation records and interview with the technical consultant, the technical consultant did not evaluate competency after the implementation of the new coagulation analyzer. Findings include: 1. The laboratory replaced the Sysmex CA 1500 coagulation analyzer with the Instrumentation Laboratory ACL TOP 300 CTS coagulation analyzer effective March 26, 2018. Staff training to operate the new coagulation analyzer was completed in March 2018 prior to the go-live of the new analyzer but staff competency evaluation was not reevaluated for the use of the new instrumentation. 2. Interview with the technical consultant on June 12, 2019 at 12:45 PM confirmed that staff competency evaluation was not assessed with the new coagulation analyzer. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the verification studies performed for the new Antinuclear Antibody (ANA) test and interview with the technical supervisor, the laboratory director did not ensure the verification procedures used were adequate to determine the accuracy, precision, and other pertinent performance characteristics for the ANA test prior to performing patient testing. Findings include: 1. Review of the verification -- 2 of 3 -- studies performed for the Nova Lite HEp-2 ANA assay showed that this assay testing started July 16, 2018. Verification studies to determine the accuracy, precision, and other pertinent performance characteristics were not reviewed and approved by the laboratory director prior to performing patient testing. 2. Interview with the technical supervisor on June 12, 2019 at 3:00 PM confirmed that the new ANA assay verification studies to ensure acceptable test performance had not been reviewed or approved by the laboratory director prior to patient testing. -- 3 of 3 --