Uw Health-Union Corners Lab

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on review of individualized quality control plans (IQCPs) and interview with Technical Consultant (Staff C), three of three IQCPs did not specify the type of external quality control (QC) materials being used for respiratory virus, serum pregnancy, and troponin-I testing performed in the laboratory. Findings include: 1. Review of the three IQCPs revealed that the IQCPs did not include specific information about the type of testing control materials being used for external QC such as manufacturer, type, how many, and which level(s). 1a. "SAT. Genexpert IQCP Union Corners" (Effective date: 07/01/2025) stated "Analyze two levels of QC", but did not specify manufacturer, type, and which level(s). 1b. "SAT. Serum Preg IQCP Union Corners" (Effective date: 07/07/2025) stated "Analyze three levels of QC", but did not specify manufacturer, type, and which level(s). 1c. "Union Corners Stratus IQCP" (Effective date: 05/01/2025) stated "Two levels of QC are run for Troponin Testing purchased from Bio-Rad", but did not specify the type and which levels. 2. Interview with Staff C on July 10, 2025, at 2:15 PM confirmed that 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 -- the IQCPs did not include specific information about the type of external QC materials being used for respiratory virus, serum pregnancy, and troponin-I testing performed in the laboratory. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and communication sent from this laboratory to the state agency and interview with the Director, Laboratory Services (Staff D), the Laboratory Director did not ensure compliance with the regulation at 493.51(b), 'Notification Requirements for Laboratories Issued a Certificate of Compliance', when the laboratory added non-waived testing in one of one new subspecialty and did not notify the Department of Health and Human Services (HHS) within six months of the addition of the virology sub-specialty. Findings include: 1. Review of an email communication sent by the laboratory to the state agency on May 27, 2025, showed the laboratory requested addition of the virology subspecialty effective June 15, 2025. 2. Review of laboratory records, including verification studies of virology testing on the Cepheid GeneXpert 16 module test system, showed the laboratory began patient virology testing on March 25, 2024. 3. Interview with Staff D on July 10, 2025, at 11:30 AM confirmed the laboratory director did not ensure compliance with the regulation at 493.51(b) and confirmed the laboratory did not notify HHS within six months of performing testing in the virology subspecialty, a subspecialty that was not on the laboratory's CLIA certificate prior to June 15, 2025. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review and interview with a Technical Consultant (Staff A), Staff A did not perform annual competency assessment evaluation for one (Staff B) of two testing personnel performing provider performed microscopy (PPM) procedures at this location for one out of two years reviewed. Findings include: 1. Review of annual competency assessment records revealed Staff A completed a competency assessment in 2025 at this location for Staff B. Records were not available to show Staff A had completed a competency assessment for Staff B at this location in 2024. 2. Interview with Staff A on July 10, 2025, at 8:15 AM confirmed that Staff B did not have an annual competency assessment done at this location in 2024. 3. An email communication on July 10, 2025, at 11:09 AM from Staff A revealed that Staff B -- 2 of 3 -- performed and resulted five PPM tests in 2024 at this location, indicating the need for performance of the competency assessment at this location in 2024. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on surveyor review of College of American Pathologists (CAP) proficiency testing (PT) records, laboratory records and procedures and interview with a technical consultant, staff A, the laboratory did not perform testing on proficiency testing samples in the same manner as it's patient specimens for one of one general chemistry event in 2023. Findings include: 1. Review of CAP PT general chemistry instructions for testing stated, "Unopened Stability: Specimens are stable at 2-8 degrees Celsius (C) for 14 days". 2. Review of the "CAP PT Tracking and Review Form" showed the PT specimens were received on March 7, 2023. Further review showed the specimen were tested on March 22, 2023, which is fifteen days after receipt. 3. Review of laboratory procedures showed the laboratory has a procedure for specimen stability, including specimen storage and time frames for any testing to be performed and patient testing would not be performed outside of these parameters. 4. Interview with staff A on July 18, 2023, at 10:00 AM confirmed the laboratory has guidelines in place for specimen testing and patient testing would not be performed outside of the specimen storage and timeframe for specimen stability. Further interview confirmed the laboratory performed PT testing outside the specimen stability guidelines provided by the PT provider. 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 D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation of stored blood samples, review of patient test reports and laboratory procedures, and interview with a technical consultant, the laboratory did not follow their procedures for specimen acceptability and rejection for one of one short filled blood tube collected for hematology testing on August 29, 2021. Findings include: 1. Observation of stored blood samples on September 2, 2021 at 2:30 PM revealed an EDTA (ethylenediaminetetraaceticacid) anticoagulated sample collected on August 29, 2021 with less than one milliliter of blood in the tube. The tube was identified as a sample from patient 1, collected at 5:10 PM. 2. Review of the test report for patient 1 showed the laboratory reported hematology results from the Sysmex XS-1000i on August 29, 2021. 3. The laboratory procedure, 'UWMF Satellites Sysmex XS-1000i Procedure' included the following steps in part III, Specimen Information: "Specimen should be visually inspected for hemolysis, clots and proper fill level", and "Minimum acceptable volume is a half-filled tube". 4. Interview with a technical consultant (staff A) on September 2, 2021 at 2:40 PM confirmed the EDTA tube from patient 1 did not meet the acceptability requirements for testing and the laboratory staff did not follow their procedures for specimen rejection. D5407 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on surveyor review of serum hCG (human chorionic gonadotropin) quality control and patient testing records and laboratory procedures, and interview with a technical consultant, the laboratory used the SURE-VUE Serum/Urine hCG-STAT test kit for one of one serum hCG patient tests performed between January 1, 2021 and February 1, 2021 prior to approval of the laboratory's procedure by the laboratory director. Findings include: 1. Review of quality control records for 2021 showed the laboratory was using the SureVue test kit lot HCG0042106 from January 1 through 25, 2021 and lot HCG0092078 on January 26 and February 1, 2021. On January 25, 2021, the laboratory tested two positive and one negative quality control samples using the SureVue test kit lot # HCG0042106. 2. Review of patient testing records from January 1 through February 1, 2021 showed one serum pregnancy test was performed on a sample from patient 2 on January 25, 2021. 3. Review of the "UWMF SureVue Serum Pregnancy" procedure showed the director approved the procedure on February 10, 2021. 4. Interview with a technical consultant (staff A) on September 2, 2021 at 3:00 PM confirmed testing personnel used the SureVue hCG STAT test kit to test a patient serum sample prior to the approval of the test procedure by the laboratory director. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance logs for the Architect Chemistry analyzer and interview with a technical consultant, the laboratory did not ensure replacement of the ICT (Integrated Chip Technology) module every 90 days as required by the manufacturer. Findings include: 1. Review of maintenance logs for the Architect analyzer showed the ICT module is to be replaced every 90 days or as needed. The logs show the following replacement and expiration dates for the ICT module in 2021: Replaced February 19 (module expiration date June 18, 2021) Replaced August 19 (module expiration date December 16, 2021) Maintenance logs from February through August 2021 showed no evidence of review. 2. Interview with a technical consultant (staff A) on September 2, 2021 at 10:50 AM confirmed the laboratory had no records to show the ICT module was replaced in May 2021 or that the module in place on February 19, 2021 was not used past the expiration date of June 18, 2021. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials -- 2 of 3 -- using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of two approved IQCP (Individualized Quality Control Plan) and interview with a technical consultant, two of the two new or revised IQCP did not specify the type of external control material used for testing and one did not specify the number of controls required. Findings include: 1. Review of the IQCP for the SureVue Serum/Urine hCG STAT test kit and the IQCP for Troponin I and D dimer testing on the Siemens Stratus CS showed the type of external control was not specified in either IQCP. Further review of the IQCP for the Siemens Stratus CS showed the quality control plan did not identify how many controls would be tested for Troponin I or D dimer testing. 2. Interview with a technical consultant (staff A) on September 2, 2021 at 11:20 AM confirmed the control material was not specified in the IQCP for the Sure Vue test kit or the Stratus analyzer. Further interview confirmed the laboratory did not specify the number of controls required for Troponin I or D dimer testing on the Stratus. -- 3 of 3 --