Urology Associates Of Green Bay, Sc

Summary Statement of Deficiencies D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Individualized Quality Control Plan (IQCP) provided by the laboratory as evidence of correction and other laboratory records and interview with the clinic manager (staff A) by email, the laboratory had not retained one of one IQCP for this laboratory for the Prostate Specific Antigen (PSA) test performed with the Qualigen Diagnostics FastPack analyzer and the director did not ensure the quality control program was maintained. Findings include: 1. Review of the 'IQCP for Quality Control on the Qualigen FastPack PSA' document provided by the clinic manager via email on January 16, 2025, showed the laboratory director had not signed the IQCP. Further review showed the document was not specific for the PSA test system as performed at this laboratory. a. The IQCP referenced use of College of American Pathologists (CAP) Proficiency Testing (PT). Record review during the on- site survey on December 19, 2024, showed the laboratory did not use CAP PT products. b. The IQCP identified roles for a Medical Technologist and Technical Supervisor. Review of personnel records during the on-site survey showed no evidence the laboratory had hired a Medical Technologist or Technical Supervisor. c. The IQCP addressed nucleic acid contamination and mitigation procedures that are not a risk factor for the Qualigen FastPack PSA test system. d. The IQCP stated the director or designee review all verified results prior to release. Review of test records during the on-site survey showed no evidence the director or designee reviewed all 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 -- results prior to release. e. The IQCP stated, "Appropriate utilities are employed in the laboratory to service the Verigene Instrumentation" and "All reagents used in the Xpert MRSA are used within expiration dates." Review of the laboratory's test menu showed no testing for the Xpert MRSA or testing with Verigene instrumentation. 2. Email interview with Staff A on January 22, 2025, at 1:20 PM revealed, "We couldn't locate an IQCP for Marinette for PSA. We are thinking it was thrown out with the older lab paperwork" showing the director had not ensured the quality control program was maintained. -- 2 of 2 --

Summary Statement of Deficiencies D5785

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, patient logs and interview with a clinical supervisor, staff A, the laboratory did not perform calibration verification every six months on the Qualigen FastPack immunoassay analyzer in 2022. Finding include: 1. Review of calibration verification records showed calibration verification performed on the Qualigen FastPack immunoassay analyzer on August 25, 2021, and August 9, 2022. Further review showed no evidence 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 -- additional calibration verification performed on the analyzers in 2022 when calibration verification was due on February 25, 2022. 2. Review of patient logs showed one hundred fifteen patient tests were performed between February 25, 2022, and August 9, 2022. 3. Interview with the staff A on February 14, 2023, at 10:05 AM confirmed the laboratory did not perform calibration verification every six months on the Qualigen FastPack immunoassay analyzer in 2022. -- 2 of 2 --

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 procedures and quality control records and interview with testing personnel, testing personnel did not test quality control materials with each new lot number of PSA (Prostate Specific Antigen) reagents prior to testing patient samples as specified by the manufacturer and established by the laboratory in their Individualized Quality Control Plan (IQCP). In 2020, testing personnel did not test control material before testing patient samples for two of six lot numbers used. Testing personnel tested nine patient samples before testing control materials with two new lots of PSA reagents. Findings include: 1. Review of the laboratory's PSA procedures and IQCP showed the quality control procedures require testing two levels of control material prior to testing patient samples with a new lot of reagents. 2. Review of quality control records from January through December 2020 showed testing personnel performed testing using six different lot numbers of PSA reagent throughout the year. Records showed testing personnel first tested control material with lot number 1910026-5P on March 12, 2020. Testing personnel used lot 1910026-5P for PSA testing of five patient samples on March 10, 2020 before controls were tested. Records also showed testing personnel first tested control materials with lot number 2001041-8p on July 8, 2020. Testing personnel used lot 2001041-8p for PSA testing of four patient samples on June 30 and July 1, 2020 before controls were tested. 3. Interview with testing personnel (staff A) on April 8, 2021 at 10:43 and 11:07 AM confirmed testing personnel performed patient PSA tests using reagents that had not first been tested with control materials and that testing personnel did not adhere to the laboratory's quality control procedures. 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 D6053 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 at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of competency evaluation records and interview with testing personnel A, the technical consultant did not document the semi-annual evaluation of competency for two of two new testing personnel during the first year the individuals performed testing. Findings include: 1. Review of competency evaluation records for testing personnel B showed the technical consultant performed initial competency evaluation on February 13, 2018. Semi-annual competency evaluation records were not available for review. 2. Review of competency evaluation records for testing personnel C showed the technical consultant performed initial competency on February 21, 2017 and annual competency on February 22, 2018. Semi-annual competency evaluation records were not available for review. 3. Interview with testing personnel A on January 17, 2019 at 2:00 PM confirmed the technical consultant did not evaluate competency at least semi-annually for two of two new testing personnel during the first year of testing. 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 --