Urology Associates Of Idaho Falls

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 --