North Idaho Urology

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, the competency assessment policy, competency assessment records and an interview with the general supervisor (GS) on 3/20/2024, the laboratory failed to establish and follow written policies and procedures to assess competency of all laboratory personnel. The findings include: 1. A review of the CMS 209 identified two testing personnel, a general supervisor and laboratory director that also fulfilled the role of technical supervisor. 2. A review of the competency assessment policy identified that the laboratory failed to include instructions for performing a competency assessment of the GS. 3. A review of competency assessment records identified that the laboratory failed to have a competency assessment for the GS. 4. An interview with the GS on 3/20/2024 at 1:21 pm confirmed the above findings. 5. The laboratory reports performing 47,550 tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of 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 2 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 training and competency assessment records, laboratory procedures, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview with the general supervisor on 4/27/2022, the laboratory failed to establish and follow written policies and procedures to assess employee competency. The findings include: 1. The CMS 209 identifies one (1) testing personnel performing moderate complexity urine microscopic and post vasectomy testing. 2. A review of laboratory procedures identified that the laboratory failed to establish policies or procedures to assess employee initial, semiannual and annual competency. 3. A review of training and competency assessment records identified that the laboratory failed to have competency assessments for 2021 for one (1) of one (1) testing personnel performing urine microscopic and post vasectomy testing. 4. An interview with the general supervisor on 4/27/2022 at 2:18 pm, confirmed that there was no documented 2021 competency assessments for one (1) of one (1) testing personnel performing urine microscopic and post vasectomy testing. 5. The laboratory reports performing 6600 urine microscopic tests and 80 post vasectomy tests annually. 6. This is a repeat deficiency from the survey performed on 1/5/2021. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 a review of laboratory's proficiency test results and an interview with the general supervisor on 4/27/22, the laboratory failed to verify the accuracy of urine microscopic testing twice annually. The findings include: 1. A review of the laboratory's proficiency test results identified that the laboratory failed to perform biannual verification of testing performance for urine microscopic testing for 2021. 2. An interview with the general supervisor on 4/27/2022 at 2:34 pm confirmed that biannual verification for urine microscopic testing for 2021 was not performed. 3. The laboratory reports performing 6600 urine microscopic tests annually. D5807 TEST REPORT CFR(s): 493.1291(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. This STANDARD is not met as evidenced by: Based on a review of patient test reports and an interview with the general supervisor on 4/27/2022, the laboratory failed to include normal values on final test reports. The findings include: 1. A review of patient test reports identified that the laboratory failed to include normal values for urinalysis and post vasectomy testing on patient final test reports. 2. An interview with the general supervisor on 4/27/2022 at 4:30 confirmed that urinalysis and post vasectomy test reports failed to include normal values. 3. The laboratory reports performing 6600 urine microscopic tests and 80 post vasectomy tests annually. -- 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 Proficiency Testing (PT) record review, and an interview with the testing person on 01/05/2021, the laboratory director failed to sign and date the PT attestation statements provided by the American Association of Bioanalytics (AAB). The findings include: 1. A record review of PT documents revealed that there were no AAB PT attestation statements signed and dated by the laboratory director for 3 of 3 events in 2020. 2. An interview with the testing person on 01/05/2021 at 3:50 PM confirmed the above findings. 3. The laboratory reports performing 3,600 urine microscopic examinations and 2,600 Prostate Specific Antigen (PSA) patient specimens and 280 hematology patient specimens annually. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review of competency assessments, the CMS-209 personnel form, and an interview with the testing person on 01/05/2021, the laboratory failed to follow written policies and procedures to assess competency for testing personnel. The findings include: 1. A record review of competency assessments revealed that one of one testing personnel listed on the CMS-209 personnel form did not have competency assessments performed in 2019 and 2020. 2. An interview with the testing person on 01/05/2021 at 1:40 PM confirmed the above findings. 3. The laboratory reports performing 3,600 urine microscopic examinations and 2,600 Prostate Specific Antigen (PSA) patient specimens and 280 hematology patient specimens annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review of the laboratory's routine urinalysis procedure, and an interview with the testing person on 01/05/2021, the laboratory failed to follow the written procedure for centrifuging urine sediment for microscopic examination. The findings include: 1. A record review of the laboratory's routine urinalysis procedure revealed the laboratory was not following the written procedure to centrifuge the urine for 5 minutes, urine specimens are centrifuged for 2 minutes. 2. An interview with the testing person on 01/05/2021 at 4:35 PM confirmed that patient urine specimens are centrifuged for 2 minutes. 3. The laboratory reports performing 3,600 urine sediment microscopic examinations annually. -- 2 of 2 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) review and an interview with the laboratory lead, the laboratory failed to test proficiency samples from American Association of Bioanalysts (AAB) in the same manner as it tests patient samples since the last survey on June 7, 2016. Findings: 1. A record review of the AAB urine culture, extent 3, PT program subscribed by the laboratory revealed the laboratory reported only gram negative or gram positive organisms and not presumptive genus identification of organisms as performed on patient samples. 2. An interview on July 25, 2018 at 12:30 PM, with the laboratory lead, confirmed the laboratory failed to properly report the proficiency testing urine culture tests in the same manner as the laboratory tests and reports patient samples. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to test the American Association of Bioanalysts (AAB) proficiency testing (PT) samples for urine cultures by the same personnel who perform patient testing since the last survey on June 7, 2016. Findings: 1. An AAB PT record review revealed the laboratory failed to rotate the urine culture PT samples with the second testing personnel who performed patient testing since the last survey. 2. An interview on July 25, 2018 at 11:30 AM, with the laboratory lead, confirmed the laboratory failed to rotate the proficiency samples from AAB among all personnel who perform patient tests since the last survey. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and an interview with the laboratory lead, the laboratory director failed to sign the attestation statements from the American Association of Bioanalysts (AAB) for the specialty of microbiology and chemistry from January 2017 through July 2018. Findings: 1. An AAB PT record review from 2017 through 2018, revealed the laboratory director failed to sign the attestation statements for the specialty of microbiology and chemistry. 2. An interview on July 25, 2018 at 12:10 PM, with the laboratory lead, confirmed the laboratory director failed to sign the attestation statements from 2017 and 2018 events. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation, records review, and interview, the condition of bacteriology is not met based on the findings in D5471, D5477, D5507, and D5787. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory lead, the laboratory failed to verify the accuracy of microscopic examinations of urine sediment, semen, -- 2 of 9 -- and fungal presence at least twice annually since the last survey on June 7, 2016. Findings: 1. A record review of revealed the laboratory failed to document the accuracy at least twice annually for microscopic examinations of urine sediment, the presence and motility of post-vasectomy semen samples, and fungal elements from culture plates since the last survey. 2. An interview on July 25, 2018 at 1:45 PM, with the laboratory lead, confirmed the laboratory failed to document the accuracy of the three microscopic tests at least twice annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)