Hayden Lake Family Physicians

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of proficiency testing (PT) documentation from the American Association of Bioanalysts (AAB) and an interview with the laboratory lead on 12/10 /2025, the laboratory failed to have the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2024 and 2025. The findings include: 1. A review of PT results from AAB for 2024 identified that the laboratory failed to have the laboratory director attest that the PT samples were tested with patient samples for events two and three for non-chemistry. 2. A review of PT results from AAB for 2025 identified that the laboratory failed to have the laboratory director attest that the PT samples were tested with patient samples for three of three events for non-chemistry. 3. An interview with the laboratory lead on 12/10/2025 at 9:16 am confirmed the above findings. 4. The laboratory reports performing 21,852 hematology tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American 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 -- Association of Bioanalysts (AAB), and an interview with the laboratory lead on 12/10 /2025, the laboratory director failed to review PT results in 2024 and 2025. The findings include: 1. A review of PT documents for 2024 from AAB identified that the laboratory director failed to review graded results for non-chemistry events one, two and three. 2. A review of PT documents for 2025 from AAB identified that the laboratory director failed to review graded results for non-chemistry events one, two and three. 3. An interview with the laboratory lead on 12/10/2025 at 9:16 am confirmed that the laboratory director failed review the above PT results. 4. The laboratory reports performing 21,852 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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 documentation, competency assessments, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and an interview on 2 /8/2022 with the laboratory lead, the laboratory failed to follow written policies and procedures to assess testing personnel training and competency for 2021. The findings include: 1. A review of training and competency records identified that one (1) of thirteen (13) testing personnel listed on the CMS 209 had a start day after the previous survey (11/18/2020) that the laboratory failed to have documentation of initial training for hematology testing. 2. A review of training and competency records identified one (1) of thirteen (13) testing personnel listed on the CMS 209 that the laboratory failed to have documentation of six (6) month competency in 2021 for hematology testing. 3. A review of training and competency records identified four (4) of thirteen (13) testing personnel listed on the CMS 209 that the laboratory failed to have documentation of annual competency in 2021 for hematology testing. 4. An interview with the laboratory lead on 2/8/2022 at 1:00 pm confirmed the above findings. 5. The laboratory reports performing 29,000 hematology 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 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)