Urology Associates Of Green Bay Sc

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with a testing person (Staff A), the laboratory did not verify the accuracy of unscored analytes in five of five events from event three in 2022 through event one in 2024. Findings include: 1. Review of the American Proficiency Institute (API) reports for microbiology events 2022-03 through 2024-01 showed each of the five events included results that the PT program had not evaluated. The reports stated, "Laboratories ... must perform a self-evaluation using statistics presented in the Participant Data Summary for samples that have not been graded." The 2022 Microbiology third event included ten not graded results in the Molecular Resistance Genes - Urine section. The 2023 Microbiology first event included not graded results for Sample UTI-05 for Enterobacter cloacae and sample UTI-01 for Candida tropicalis and thirty-three not graded results in the Molecular Resistance Genes - Urine section. The 2023 Microbiology event two included twenty-five not graded results in the Molecular Resistance Genes - Urine section. The 2023 Microbiology event three included a not graded result for Ureaplasma urealyticum sample UTI-14 and thirty not graded results in the Molecular Resistance Genes - Urine section. The 2024 Microbiology event one included twenty-seven not graded results in the Molecular Resistance Gene - Urine section. The records showed no evidence the laboratory reviewed any of the not graded results. 2. Interview with Staff A on July 3, 2024, at 11:35 AM confirmed the laboratory did not review the not graded results to verify accuracy. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of procedures, observation of the centrifuge in the laboratory, and interview with a testing person (Staff A), the laboratory did not perform a function check to verify one of three centrifuge settings to ensure the revolutions per minute (rpm) achieved for urine sample preparation for microscopic analysis was acceptable. Findings include: 1. Review of the procedure for urine microscopic analysis showed the laboratory required urine sample centrifugation at 1500 rpm prior to microscopic examination. 2. Observation of the laboratory centrifuge on July 3, 2024, at 10:15 AM showed the centrifuge had three settings with setting C identified for use with urine samples. The centrifuge had a label dated June 25, 2024, with function check results for one setting that showed the rpm target was 3622 rpm and the actual reading was 3702 rpm. The label did not identify which of the three centrifuge settings produced the documented reading. 3. Interview with Staff A on July 3, 2024, at 10:20 AM confirmed a contractor had checked the centrifuge speed recently. Further interview confirmed Staff A used setting C to centrifuge urine samples and confirmed the function check did not show the rpm required for urine microscopic testing was acceptable. 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 laboratory records and interview with a testing person -- 2 of 5 -- (Staff A), records for the calibration verification of the PSA (Prostate Specific Antigen) test performed on the Tosoh AIA analyzer were not available for three of the last four scheduled verifications. Findings include: 1. Review of laboratory records revealed personnel performed PSA calibration verification testing in June 2024. Further review showed no records of the calibration verifications due in December 2022, June 2023, or December 2023. 2. Interview with Staff A on July 3, 2024, at 12: 30 PM confirmed they did not know where to find the records of calibration verification from December 2022 or the two events in 2023 for the PSA test. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved

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 quality control (QC) records and Individualized Quality Control Plan (IQCP) and interview with the general supervisor, the laboratory director did not document review of the IQCP plan to ensure the quality control plan was established for the BioRad CFX96 Pathogen Multiplex polymerase chain reaction (PCR) test. Findings include: 1. Review of QC records showed four assay controls were run with each patient and external QC was being performed weekly on the BioRad CFX96 Pathogen Multiplex PCR test. 2. Review of the BioRad CFX96 Pathogen Multiplex PCR test IQCP showed data had been compiled for external QC to be performed weekly. Further review showed no documentation of review and acceptance by the laboratory director to institute the use of the IQCP. 3. Interview with the general supervisor on October 17, 2022, at 11:35 AM confirmed the laboratory director did not document review of the IQCP plan to ensure the quality control plan was established for the BioRad CFX96 Pathogen Multiplex polymerase chain reaction (PCR) test. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency 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 -- all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on surveyor review of the test menu and personnel records and interview with the general supervisor, the technical consultant (who is the laboratory director) did not provide training or competency assessment for two of two testing personnel to ensure staff were competent to perform microscopic urinalysis evaluations. Findings include: 1. Review of the test menu showed the facility began urine microscopy testing on September 20, 2021. 2. Review of personnel training and competency records showed no documentation of training or competency assessment for microscopic urinalysis evaluations for two of two testing personnel, staff A and staff B. 3. Interview with the general supervisor on October 17, 2022, at 11:30 AM confirmed the technical consultant (who is the laboratory director) did not provide training or competency assessment for two of two testing personnel to ensure staff were competent to perform microscopic urinalysis evaluations. -- 2 of 2 --