Biomat Usa Inc

Summary Statement of Deficiencies D0000 A validation survey was conducted by the Idaho CLIA state agency at the facility on June 11, 2025. The laboratory was found out of compliance with the following standard: 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, laboratory procedures, training and competency assessment records and an interview with the Quality Systems Manager on 6/11/2025, the laboratory failed to establish a procedure for competency assessments for the technical consultant (TC) in 2023, 2024 and 2025. The findings include: 1. The CMS 209 identified 22 testing personnel (TP) performing moderate complexity testing and one TC. 2. A review of laboratory procedures identified that the laboratory established a procedure to assess TP initial training, semiannual and annual competency but failed to establish a procedure for competency assessment performance for the TC. 3. A review of training and competency assessment records identified that the laboratory failed to have a competency assessment for the TC in 2023, 2024 and 2025. 4. An interview with the Quality Systems Manager on 6/11/2025 at 10:38 am confirmed the above findings. 5. The laboratory reports performing 38,400 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 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 a review of proficiency testing (PT) records from Accutest, refractometer comparison forms and an interview with the center manager on 12/2/2021, the laboratory failed to test the total protein PT samples in the same manner as patient samples are tested. The findings include: 1. A review of PT records for total protein testing from Accutest for 2021 event one and the laboratory refractometer comparison forms identified that the laboratory testing personnel performed PT testing on March 26, 2021 and performed refractometer comparison testing on March 27, 2021 using the 2021 event one PT samples. The laboratory failed to test the PT samples in the same routine manner as used for testing patient samples. 2. An interview with the center manager on 12/2/2021 at 1:45 pm confirmed that the laboratory failed to test the PT samples in the same manner that patient samples are tested. 3. The laboratory reports performing 25,000 total protein 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 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 record review and interview it was revealed that the laboratory failed to document the humidity in the area where the Reichert refractometers were in use. Findings: 1. A review of environmental records from 2018 and 2019 revealed no documentation of the humidity in the area where the Reichert refractometers were used for testing client specimens. 2. A review of the Reichert Analytical Instruments TS Meter - DSP User's Guide Revision 13970000-100 on page 4 revealed a required operating relative humidity as follows: 80% for temperatures to 31 degrees Celsius decreasing linearly to 50% (relative humidity at 40 degrees Celsius. 3. An interview on 03/10/2020 at 11:00 AM with the center manager confirmed that no documentation of humidity was available. 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 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 personnel record review and an interview with the laboratory manager, the laboratory failed to establish a policy to assess the competency for the position responsibilities of the technical consultant since the last survey on March 23, 2016. Findings: 1. A record review of the technical consultant competency assessment revealed the laboratory failed to evaluate the position responsibilities for the technical consultant. 2. An interview on February 7, 2018 at 2:00 PM, with the laboratory manager, confirmed the laboratory failed to evaluate the technical consultant responsibilities. D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on personnel record review and an interview with the laboratory manager, the technical consultant failed to evaluate intermediate test results and preventive maintenance records as part of the annual competency assessment for all testing personnel since the last survey on March 23, 2016. Findings: 1. A record review of 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 -- personnel competency assessments revealed the technical consultant failed to assess intermediate test results and preventative maintenance records for 14 out of 14 testing personnel listed on the CMS-209 form. 2. An interview on February 7, 2018 at 2:00 PM, with the laboratory manager, confirmed that intermediate test results and preventative maintenance failed to be documented. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on personnel record review and an interview with the laboratory manager, the laboratory failed to evaluate the competency of testing personnel by direct observation of performance of instrument maintenance and function checks since the last survey on March 23, 2016. Findings: 1. A record review of personnel competency assessments revealed the technical consultant failed to evaluate testing personnel by direct observation of instrument maintenance and function checks for 14 out of 14 testing personnel listed on the CMS-209 form. 2. An interview on February 7, 2018 at 2:00 PM, with the laboratory manager, confirmed that performance of instrument maintenance and function checks failed to be documented. -- 2 of 2 --