Arizona Urology Specialists, Llc - Tpk

Summary Statement of Deficiencies D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of quality control records for semen analysis testing and interview with the technical supervisor (TS), the laboratory failed to establish and define acceptable ranges for the control material, Accu-Beads+. Findings include: 1. The laboratory performs Semen Analysis testing (count and morphology) under the specialty of Hematology with a reported annual test volume of 800. The laboratory uses a Makler chamber to perform the sperm count. 2. The QC ranges listed on the laboratory's QC forms failed to align with the manufacturer's QC ranges for the Accu- Beads+ control material. 3. The laboratory's QC forms used from January 1, 2023 through the survey date on January 9, 2025 indicated two levels of Accu-Beads+ QC material are used each day of patient testing with the following acceptable ranges: - Accubead Count 1 - (30-40 M/ml) using a Leja chamber, (33-59 M/ml) using a Makler chamber - Accubead Count 2 - (15.5-20.5 M/ml) using a Leja chamber, (16-30 M/ml) using a Makler chamber 4. The manufacturer's package insert for the Accu- beads+ control material in use at the time of the survey (lot# 232908181, exp. 09 /2025) failed to list an acceptable range for QC results if using a Makler chamber. The package insert listed the following: - For Fixed Coverslip Chambers: vial 1 = 35 +/- 5 M/ml, vial 2 = 18 +/- 2.5 M/ml - For Hemacytometer: vial 1 = 46 +/- 7 M/ml, vial 2 = 23 +/- 4 M/ml 5. The laboratory failed to provide documentation of established control procedures for the control material, Accu-Beads+, using a Makler chamber, specifically establishment of the QC ranges that are listed on the laboratory's QC forms for the Makler chamber. 6. The TS interviewed on 1/09/25 at 10:45 AM acknowledged that the laboratory could not produce documentation to show the QC 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 -- ranges listed on the laboratory's QC forms for the Makler chamber were established by the laboratory. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of proficiency testing (PT) attestation statements for review from 2021 and 2022 and interview with the testing personnel, the laboratory failed to provide evidence of the testing personnel and director's attestations to the routine integration of PT samples into the workload using the laboratory's routine methods. Findings include: 1. The laboratory participates in two PT events annually for Semen Analysis testing. 2. The PT attestation statements from each testing event of 2021 and 2022 were not provided to the surveyor for review during the survey conducted on February 1, 2023. 3. The testing personnel interviewed on 2/01/23 at 10:30am acknowledged that the attestation statements indicated above were not available for review at the time of the survey. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 -- ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2021 and interview with the testing personnel, the laboratory failed to document

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on lack of proficiency testing (PT) attestation statements presented for review for 2016 and 2017 and interview with the facility personnel, the laboratory failed to provide evidence of the testing personnel and director's attestations that PT samples were tested in the same manner as patient specimens. Findings include: 1. The laboratory performs semen analysis and anti-sperm antibody(ASA) testing under the specialty of Hematology and the sub-specialty, General Immunology with an approximate annual test volume of 576. The laboratory participates in two annual PT events as a means to verify the accuracy of testing. 2. PT attestation statements for each event of 2016 and 2017 were not provided to the surveyor for review. 3. The facility personnel acknowledged that the attestation statements indicated above were not available for review at the time of the survey. 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 --