Urology Associates Of Idaho Falls

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 a review of the NanoEntek FREND manufacturer user manual, a lack of laboratory room temperature and humidity records and an interview with testing personnel 1 (TP1) on 2/9/2026, the laboratory failed to monitor the testing temperature and humidity for the NanoEntek FREND since moving in September 2025. The findings include: 1. A review of the user manual for the NanoEntek FREND analyzer identified an operational room temperature of 18-20 C and a humidity of 20-80%. 2. A review of the laboratory temperature log identified the laboratory failed to monitor room temperature and humidity per the NanoEntek FREND manufacturer requirements 22 of 22 working days in September 2025, 23 of 23 working days in October 2025, 18 of 18 working days in November 2025, 16 of 16 working days in December 2025, 20 of 20 working days in January 2026 and 6 of 6 working days in Feburary 2026. 3. An interview with TP1 on 2/9/2026 at 2:14 pm confirmed that the laboratory failed to monitor room temperatures and humidity since moving in September 2025. 4. The laboratory reports performing 2,300 prostate specific antigen tests on the NanoEntek FREND annually. D5775 COMPARISON OF TEST RESULTS 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 -- CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with technical consultant 1 (TC1) on 2/9/2026, the laboratory failed to evaluate prostate specific antigen (PSA) results performed on their three (3) NanoEntek FREND analyzers twice annually to ensure that results were within the allowed acceptable difference between the analyzers since 9/11/2023. The finding include: 1. A lack of documentation for analyte result comparison between the laboratory's three (3) NanoEntek FREND analyzers identified that the laboratory failed to evaluate test results for PSA two (2) of two (2) times in 2024 and two (2) of two (2) times in 2025 to ensure that test results were within the allowed acceptable difference between the three (3) analyzers. 2. An interview with TC1 on 2/9/2026 at 2:57 pm confirmed that the laboratory failed to compare analyte results between analyzers to ensure accurate patient testing. 3. The laboratory reports performing 2,300 PSA tests annually. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of laboratory patient test reports and an interview with testing personnel 1 (TP1) on 2/9/2026, the laboratory failed to include the new address of the performing laboratory since September 1, 2025. The findings include: 1. A review of laboratory patient test reports for prostate specific antigen (PSA) identified that the laboratory failed to change the address of the performing laboratory since moving in September 2025. 2. An interview with the TP1 on 2/9/2026 at 3:19 pm confirmed that the address was not changed after the move. 3. The laboratory reports performing 2,300 PSA test annually. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of laboratory patient test reports and an interview with the testing personnel 1 (TP1) on 2/9/2026, the laboratory failed to include the reference or normal range for all prostate specific antigen (PSA) results on final patient reports since the last inspection on 4/23/2023. The findings include: 1. A review of laboratory patient reports for PSA testing identified that the laboratory failed to include the reference or normal ranges since their last inspection on 4/23/2023. . 2. An interview with TP1 on 2/9/2026 at 3:19 pm confirmed that this was the report provided to patients. 3. The laboratory reports performing 2,300 PSA tests annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of temperature logs, Proficiency Testing (PT) documents, a lack of documentation, and interviews with testing personnel 1 and technical consultant 1 on 2 /9/2026, the laboratory director failed to ensure that the instrument testing environment was acceptable, that PT graded results were acceptable, that instrument verifications were performed after a laboratory move, that instrument comparisons were performed between the three (3) NanoEntek FREND analyzers to ensure accurate and reliable patient results, and that the laboratory had an adequate quality assurance plan. See D6013, D6018, D6020. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on a review of the NanoEntek FREND instrument verification documentation and an interview with technical consultant 1 (TC1) on 2/9/2026, the laboratory director failed to ensure that verification of instrument performance specifications were performed for three (3) of three (3) analyzers after the laboratory moved locations before beginning patient testing in September 2025. The findings include: 1. A review of the instrument verification documentation for the three (3) NanoEntek FREND analyzers identified that the laboratory director failed to ensure that manufacturer performance specifications were verified after moving to a new location before beginning patient testing on September 1, 2025. 2. An interview with TC1 on 2 /9/2026 at 3:23 pm confirmed that the laboratory director failed to ensure instrument verifications were performed on the three (3) NanoEntek FREND analyzers prior to patient testing. 3. The laboratory reports performing 2,300 tests on the NanoEntek FREND analyzers annually. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) -- 3 of 4 -- (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessments and an interview with the technical consultant (TC) on 4/27/2023, the laboratory failed to have documentation of annual competency for two (2) of 10 testing personnel in 2022. The findings include: 1. A review of competency assessments identified that the laboratory failed to have annual competency assessment for one testing personnel (TP1) performing testing on the NanoEntek FREND and and for one testing personnel (TP2) performing urine microscopic examinations listed on the CMS 209 for 2022. 2. An interview with the TC on 4/27/2023 at 1:09 pm confirmed that there was no annual competency assessment for TP1 and TP2 for 2022. 3. The laboratory reports performing 2783 tests annually. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API), the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessments and an interview with Testing personnel 1 (TP1) on 6/9 /2021, the laboratory failed to test PT samples with the regular patient workload by personnel who regularly perform the laboratory testing. The findings include: 1. A review of the CMS 209 and competency assessments identified nine (9) testing personnel testing prostate-specific antigen (PSA) on the Nanoentek Frend analyzer. 2. A review of PT records from API for Chemistry core for 2020 events one, two and three and 2021 event one identified that one of nine testing personnel performed all PT events for 2020 and 2021. The laboratory failed to have eight (8) of (9) personnel who regularly perform PSA testing perform PSA PT testing. 3. An interview with TP1 on 6/9/2021 at 9:20 am confirmed that one (1) of (9) testing personnel performed all the PSA PT testing for 2020 and 2021. 4. The laboratory reports performing 1300 PSA tests annually. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and an interview with the office manager on 6/9/2021, the Laboratory Director failed to approve, sign and date the prostate-specific antigen (PSA) individualized quality control plan (IQCP). The findings include: 1. A record review of laboratory policies and procedures identified that the current laboratory director failed to approve, sign and date the PSA IQCP for the Frend analyzer. 2. An interview with the office manager on 6/9/2021 at 9:41 am confirmed that the PSA IQCP was not signed by the current laboratory director at the time of survey. 3. The laboratory reports performing 1300 PSA tests annually. 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 a random review of temperature logs for 2019, 2020 and 2021 and an interview with testing personnel 2 (TP2) on 6/9/2021, the laboratory failed to document temperatures and humidity to ensure accurate and reliable testing on the Nanoentek Frend. The findings include: 1. A random review of temperature logs for 2019, 2020 and 2021 identified that the laboratory failed to document temperatures and humidity for all days the laboratory was in operation. Room temperature, humidity, refrigerator and freezer temperatures were not documented 9 of 23 days in July 2020, 8 of 21 days in August 2020, 5 of 22 days in September 2020 and 7 of 22 days in October 2020. The technical consultant reviewed and initialed all temperature logs for the above months but failed to document any

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical consultant, the laboratory failed to follow the Nanotek Frend analyzer instruction to include the identity of the prostate-specific antigen (PSA) test methodology on 2 out of 2 patient PSA test reports reviewed in May 2019. Findings: 1. A review the of Nanotek Frend assay instruction sheet for PSA reagent revealed the requirement for the test methodology be indicated on the patient results reported to providers. 2. A review of 2 out of 2 patient PSA reports from May 2018, revealed the patient reports failed to include the identity of the PSA assay to providers. 3. The laboratory performed approximately 600 PSA tests in 2018. 4. An interview with the technical consultant on June 25, 2019 at 12:15 PM, confirmed the patient PSA reports failed to include the identity of the PSA methodology. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Based on a review of quality control records and an interview with the technical consultant, the laboratory failed to use in-date quality control materials for the prostate-specific antigen (PSA) test performed on the Nanotek Frend on April 26, 2019. Findings: 1. A review of the PSA quality control (QC) records revealed the laboratory failed to use in-date quality control materials for April 2019 QC performance. 2. The laboratory performed approximately 66 PSA tests on patients in April 2019. 3. An interview with the technical consultant on June 25, 2019 at 11:35 AM, confirmed the laboratory staff failed to perform QC activities with quality control materials not expired. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the technical consultant, the laboratory failed to document the training for 1 out of 3 testing personnel performing Prostate-specific antigen (PSA) tests on the Nanotek Frend since November 2018. Findings: 1. A record review of personnel documents revealed training documents for 1 out of 3 testing personnel performing PSA tests on the Frend analyzer was not documented prior to testing patients in November 2018. 2. An interview with the technical consultant on June 25, 2019 at 11:10 AM, confirmed the 1 laboratory testing person failed to have documented training prior to testing patient samples. -- 2 of 2 --