Fairbanks Urology

Summary Statement of Deficiencies D0000 The Fairbanks Urology laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a focused complaint survey on 12/08 /2025. No deficiencies related to the focused complaint survey were found however; a full recertification survey was performed and the following deficiencies were found. 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 manufacturer's package inserts, patient test reports, and an interview with the laboratory supervisor (LS), the laboratory failed to follow the manufacturer's instructions for reporting the Total Prostate Specific Antigen (PSA) using the Tosoh since April 2025. The findings include: 1. The Tosoh ST AIA-PACK PA package insert for PSA states: 'It is mandatory that results reported by the laboratory to the physician include the identity of the assay used.' 2. A review of eight (8) patient reports on 12/8/25 at 2:20 PM revealed: a. Two (2) of two (2) patient test results (account numbers 13915 and 45873) that were reported after testing resumed did not include the identity of the Tosoh PA assay for PSA. b. Six (6) of six (6) patient test results (account numbers 15389 and 36413) that were reported prior to testing being temporarily halted revealed the patient test results did include the identity of the Tosoh PA assay for PSA. 3. The LS confirmed these findings in 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 -- interview at 2:20 PM on 12/8/2025. 4. The laboratory reports performing 1500 PSA tests annually. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on review of competency assessments and a phone interview with the technical consultant (TC), the technical consultant failed to complete direct observations of patient testing for three (3) of three (3) competency assessments. The findings include: 1. Review of Tosoh AIA-900, DxH 520, and urinalysis competency assessments and supporting documentation for testing personnel one (TP1) revealed the procedure of direct observation was completed by performing a record review of results, controls, and calibrators. 2. A phone interview with TC on 12/8/25 at 3:00 PM confirmed that TC was not on-site to perform competency assessment. 3. The laboratory reports performing 20320 tests annually. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on review of competency assessments and a phone interview with the technical consultant (TC), the technical consultant failed to complete direct observations of instrument maintenance for three (3) of three (3) competency assessments. The findings include: 1. Review of Tosoh AIA-900, DxH 520, and urinalysis competency assessments and supporting documentation for testing personnel one (TP1) revealed the procedure of direct observation was completed by performing a record review of maintenance logs. 2. A phone interview with TC on 12/8/25 at 3:00 PM confirmed that TC was not on-site to perform competency assessment. 3. The laboratory reports performing 20320 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 condition: successful participation [proficiency testing] D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site desk review of the laboratory's 2025 American Association of Bioanalysts (AAB) proficiency testing records and an email with the laboratory 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 -- director on 11/11/25 , it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the Hematology Red Blood Cell /Erythrocyte (RBC) count in two (2) out of three (3) Hematology testing events. See D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on an off-site desk review of the laboratory's 2025 American Association of Bioanalysts (AAB) proficiency testing records and an email with the laboratory director on 11/11/25 , it was determined the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for the Hematology Red Blood Cell /Erythrocyte (RBC) count in two (2) out of three (3) Hematology testing events. Findings include: 1. Desk review of the laboratory's 2025 AAB PT records revealed RBC count scores of less than eighty (80) percent for the following Hematology events: 2025 AAB-MLE M1 - score of 0% 2025 AAB-MLE M3 - score of 40% 2. In an email with the laboratory director on 11/11/2025, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

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 review of patient test results and an interview with the laboratory director, the laboratory failed to follow the manufacturer's instructions for reporting prostate specific antigens (PSA) using the Tosoh AIA-900 analyzer and AIA PSA test kits. Findings include: 1. The manufacturer's instruction for reporting PSA state "It is mandatory that results reported by the laboratory to the physician include the identity of the assay used." 2. A review of patient test reports for PSA revealed the reports lacked the identity of the assay used. 3. An interview conducted on June 23, 2023 at approximately 12:00 PM, the laboratory director confirmed the test reports were missing the required statement. 4. The laboratory reports performing approximately 1230 PSA 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 D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on surveyor observation, procedure and reference review, and interview with the Technical Supervisor, the laboratory failed to have an appropriate centrifuge for centrifuging urine samples from the time the urine sedimentation test was initiated on 10/14/2021. Findings include: 1. The laboratory has a single speed LabCorp Horizon Centrifuge, serial number 160613B1790, designed for centrifuging blood samples, last pm on 9/12/2020 determined the set speed of the centrifuge was 3290 rpm. 2. The laboratory's reference for processing urine sediment "A Handbook of Routine Urinalysis" by Sister Laurine Graff states on page 72 to centrifuge urine for 2000 rpm for 5 minutes. 3. The laboratory performs approximately 40 urine sediments per month. 4. The technical supervisor confirmed these findings on 12/2/21 at 2 pm. 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 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The laboratory is in substantial compliance with CLIA regulation (42 CFR, Part 493, effective April 24, 2003). No deficiencies were cited. 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 --