Arizona State Urology Llc

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 2022 to 2024 and interview with the laboratory director (LD), the laboratory failed to provide evidence of 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. Findings include: 1. The laboratory performs testing under the speciality of Microbiology with an annual test volume of 15,000. 2. The laboratory participates in three PT events annually for all testing performed under the specialty of Microbiology. 3. During the survey on 11/06 /24, the laboratory failed to provide evidence of the signed PT attestation statements for the first and second PT events of 2024, and third event of 2023. 4. The lab director or designated technical consultant failed to sign the attestation statement from the first PT event of 2022. 5. The LD interviewed on 11/06/24 at 12:30 PM confirmed the attestation statements indicated above were either not available for review or did not contain the appropriate signatures 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 4 -- D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Proficiency Testing (PT) records and interview with the laboratory director (LD), the laboratory failed to retain PT records for the third event of 2022 for testing performed under the specialty of Microbiology. Findings include: 1. No documentation for the third PT event of 2022 was presented including PT worksheets, instrument print outs, signed attestation statements, and final PT results and scores 2. The LD interviewed on 11/6/24 at 12:30 PM confirmed that the documentation indicated above could not be located. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records from 2022 through 2024 and interview with the laboratory director (LD), the laboratory failed to provide a documented review of PT results from the 2nd testing event of 2024, 3rd testing event of 2023, and 1st and 2nd testing events of 2022. Findings include: 1. The laboratory participates in PT for all testing performed under the specialty of Microbiology. The laboratory performs 1,500 tests annually. 2. No evidence, either by written comment or signature, was presented during the survey conducted on 11/6/2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 2nd testing event of 2024. 3. No evidence, either by written comment or signature, was presented during the survey conducted on 11/6/2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 3rd testing event of 2023. 4. No evidence, either by written comment or signature, was presented during the survey conducted on 11/6/2024 to indicate the laboratory director or other laboratory personnel reviewed the PT results for the 1st and second testing events of 2022. 5. The LD interviewed on 11/26/24 at 12:30 PM confirmed the PT results indicated above were not reviewed by laboratory personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an 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 lack of established quality assessment (QA) policies and procedures and interview with the laboratory director (LD), the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general -- 2 of 4 -- laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 11/6/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to Proficiency Testing. 2. The LD interviewed on 11/6/2024 at 1:00 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records from 2022 to 2024, review of the manufacturer's specifications for the Quantstudio 5 analyzer and interview with the laboratory director (LD), the laboratory failed to monitor and document the temperature of the room where testing is performed for 2 of 3 days of patient testing. Findings include: 1. The laboratory utilizes the Quantstudio 5 analyzer to perform high-complexity Polymerase Chain Reaction (PCR) testing on patient specimens under the specialty of Microbiology with an annual test volume of 15,000. 2. The manufacturer's specifications for the Quantstudio 5 reviewed during the survey listed an operating room temperature range of: 15C to 30C (59F to 86F) 3. The laboratory failed to provide documention demonstrating the room temperature where the Quantstudio 5 analyzer is utilized was monitored and recorded on 2 of 3 testing dates reviewed during the survey: 6/27/22 and 7/23/24. 4. The number of patients tested on the dates indicated above could not be determined at the time of the survey. 5. The LD interviewed on 11/6/2024 at 1:30 PM confirmed the laboratory failed to monitor and document the room temperature as indicated above. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures and interview with the laboratory director (LD) the laboratory failed to establish QA policies and procedures to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1256 and 493.1281 through -- 3 of 4 -- 493.1289. Findings include: 1. No QA documentation was provided for review during the survey conducted on 11/6/2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the analytic systems specified at 493.1251 through 493.1256 and 493.1281 through 493.1289. 2. The LD interviewed on 11/6/2024 at 2:00 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the analytic systems. -- 4 of 4 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of established performance specification documentation for the Laboratory Developed Test (LDT), Urinary Tract Infections (UTI) by PCR, used to test patient urine specimens and interview with the facility personnel, the laboratory failed to demonstrate the effects of the patients' clinical conditions, disease states, and medications as interfering substances that may effect the analytical specificity of the test system. Findings include. 1. During the survey conducted on January 25, 2022, no documentation was included in the establishment of performance specifications for the UTI PCR test indicating if the patients' clinical conditions, disease states, and any common medications may effect and/or inhibit the analytical specificity of the test system. 2. The facility personnel acknowledged that there was no specific analysis performed that included the effects of the patients' clinical conditions, disease states and common medications as possible interfering substances that may effect analytical specificity of the test system. 3. The laboratory started patient testing using the LDT, UTI by PCR in March 2020 and has an approximate annual test volume of 54,000. 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's established IQCP (Individualized Quality Control Plan) for the UTI PCR lab-developed test, review of Quality Control (QC) documentation, review of the UTI PCR test procedure and interview with the Laboratory Director, (A) the laboratory's Quality Control Plan (QCP) does not reflect the QC procedure performed by the laboratory; (B) the IQCP does not include a Quality Assessment (QA) plan. Findings include: 1. The laboratory started patient testing using the Lab-Developed Test (LDT), UTI by PCR, in March 2020 and has an approximate annual test volume of 54,000. The laboratory developed and implemented an IQCP for this test. A2. Review of the laboratory's QCP listed in the IQCP indicated that QC on the UTI Taqman Array Card includes a negative control performed on each card run and a Positive (B. atrophaeus) control with every sample. A3. Review of the Quality Control section located in the laboratory's test procedure titled, "Extraction Procedure for UTI qPCR Analysis" stated, "Taqman Urinary Tract Microbia Amplification Control contains a linearized multi-target plasmid with target sequences for each available urinary tract microbiota profiling assay. It can be included in profiling experiments as a positive control and for troubleshooting. It will be included on the first UTI card run monthly, after background calibration, as a stand alone sample at real-time PCR and carried through the remainder of the workflow." A4. No evidence was presented for review to indicate the monthly positive control indicated above was included in the laboratory's QCP, as part of the IQCP. A5. During an interview with the laboratory director, it was confirmed that the laboratory was performing the monthly positive control referenced above and the laboratory failed to include the monthly control requirement in the QCP. B1. The laboratory chose to develop an IQCP for UTI PCR testing performed on the ThermoFisher Quant Studio 12K Flex analyzer. As required in the CLIA regulations, an IQCP must include three parts: a Risk Assessment (RA), a Quality Control Plan (QCP), and a Quality Assessment (QA) plan. B2. The IQCP presented for review during the survey conducted on 1/25/2022 failed to include a QA plan. B3. The laboratory director acknowledged that the IQCP developed by the laboratory failed to include a QA plan. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of IQCP documents and procedures specific to the laboratory's established Quality Control Plan for testing performed on the ThermoFisher Quant Studio 12K Flex instrument, the laboratory director failed to ensure that quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5445 for findings. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on lack of quality assessment (QA) policies and procedures required as part of the IQCP established by the laboratory, the laboratory director failed to ensure that a QA program is established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. See D5445 for findings. -- 3 of 3 --