Salem Clinic Laboratory

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 review of the CMS-209 form, laboratory procedures, training and competency assessment (CA) records and an interview with the technical supervisor (TS), the laboratory failed to follow written policies and procedures to assess moderate complexity testing personnel (TP) in 2024. Findings include: 1. The CMS- 209 form identified thirteen (13) TP performing moderate complexity testing. 2. Review of the Laboratory Personnel Competency Assessment Policy states all TP competency assessments must occur annually. 3. A review of CA records identified that the TC failed to perform a CA for all moderate complexity TP in 2024. 4. Interview with the TS #1 at 10:00am on 03/04/2026 confirmed the above findings. 5. The laboratory performs 204 moderate complexity microscopy tests annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. 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 procedures, maintenance records and an interview with the technical supervisor (TS), the laboratory failed to follow written policies and procedures to perform centrifuge maintenance. Findings include: 1. Upon requesting documentation of centrifuge maintenance for 2024 and 2025, none could be produced. 2. Interview with TS #1 at 12:00pm on 03/04/2026 confirmed there were no maintenance documents for the centrifuge. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures and interview with the Technical Supervisor (TS), the laboratory failed to define and implement a procedure to evaluate testing when the same analyte is tested on different instruments twice a year. Findings include: 1. Upon requesting written documentation of test comparison results for 2024 and 2025 for the two Sysmex XN hematology instruments, none could be produced. 2. The laboratory did not have a procedure to evaluate comparison of test results for analytes that are tested on multiple instruments. 3. Interview with TS #3 at 11:00 am on 03/04/2026 confirmed there was no policy on comparison of test results for analytes that are tested on multiple instruments. 4. The laboratory performs 244,046 hematology tests annually. -- 2 of 2 --

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 review of competency records, and interview with the General Supervisor (GS)/Technical Supervisor (TS), the laboratory failed to have policies in place to assess the GS and TS competency. Findings include: 1. Review of competency records for 2023 and 2024 revealed the laboratory did not have a policy in place and did not perform competency for the GS and TS. 2. Interview with the GS/TS confirmed these findings on 03/14/2024 at 14:00 pm in the laboratory office. 3. The laboratory performs 1,366,746 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 review of the approved normal values in the laboratory procedure manual, review of patient report, and interview with the Technical Supervisor (TS), the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Ten (10) out of fourteen (14) chemistry normal values and six (6) out of twenty-two (22) listed on the laboratory information system (LIS) 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 -- report differed from those in the approved procedure manual. Findings include: 1. Review of patient report 1803950 from the LIS system revealed the following. LIS Patient Report Procedure Manual Chemistry: Alanine Amino transferase 7.0 - 42 u/L 10 - 49 u/L Albumin 3.3 - 4.9 G/DL 3.2 - 4.8 G/DL Total Protein 5.8 - 8.5 G/DL 5.7 - 8.2 G/DL Total Bilirubin 0.2 - 1.2 MG/DL 0.3 - 1.2 MG/DL Glucose 69 - 100 MG /DL 74 - 106 MG/DL Creatinine 0.30 - 1.1 MG/DL 0.50 -1.3 MG/DL Urea Nitrogen 5 - 21 MG/DL 9.0 - 23 MG/DL Carbon Dioxide 23.8 - 32.8 mEq/L 20 - 31 mEq/L Chloride 97 -110 mEq/L 99- - 109 mEq/L Potassium 3.4 - 4.8 mEq/L 3.5 - 5.5 mEq/L Hematology: Hemoglobin 12.4 - 15.5 G/DL 11.8 - 15.5 G/DL Mean Cell Volume 84. - 99.8 fL 81.5 - 100.5 fL Mean Corpuscular Hemoglobin 26.9 - 32.6 fL 26.1 - 33.3 fL Neutrophils # 1.9 - 6.63 10*3/uL 1.39 - 6.69 10*3/uL Lymphocyte # 1.03 - 2.82 10*3 /uL 0.84 - 3.08 10*3/uL Basophils # 0.01 - 0.07 10*3/uL 0.00 - 0.08 10*3/uL 2. Interview with the TS confirmed the laboratory failed to ensure correct references ranges approved in the procedure manual were the same as in the LIS patient reports on 03/14/2024 at 14:00 pm in the laboratory office. 3. The laboratory performs 1,048,442 chemistry tests and 244,561 hematology tests annually. -- 2 of 2 --