West Jefferson Medical Center-Ridgelake Imaging

Summary Statement of Deficiencies D0000 A Recertification survey was performed at West Jefferson Medical Center Ridgelake Imaging, CLIA ID 19D2221312, on January 13, 2026. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 review of the laboratory's proficiency test records and interview with personnel, the laboratory failed to ensure the Laboratory Director signed the attestation statement form for one (1) of six (6) proficiency testing (PT) events reviewed for Creatinine. Findings: 1. Review of the laboratory's College of American Pathologists (CAP) proficiency testing records for 2024 and 2025 revealed the Laboratory Director did not sign the attestation form for the 2025 AQ-C event. 2. In interview on January 13, 2026 at 9:35 am, the Laboratory Director confirmed she did not sign the attestation statement form for the identified PT event. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. 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 the laboratory's policies, records, and interview with personnel, the laboratory failed to follow their established procedures for the laboratory information system (LIS) verification for two (2) of two (2) years reviewed. Findings: 1. Review of the laboratory's "LIS System Verification" policy revealed "Evaluation and verification of computer-performed calculations is required upon initial implementation and thereafter annually or when a system change is made that may affect the calculation of patient results. Once monthly, or at appropriate frequency, a random historical patient's POC creatine {sic} is obtained from Telcor QML and printed. Additionally, manual calculation is performed to ensure that the system's auto calculated results are accurate. Compare the online calculated eGFR to the eGFR result on the EPIC specimen report to ensure that they are in concordance." 2. Review of the laboratory's records revealed the laboratory did not perform the following LIS verification procedures: a) Annual LIS check for 2024 b) Monthly random historical patient creatinine review for 2024 and 2025 3. In interview of January 13, 2026 at 11: 03 am ,the Laboratory Director stated she performed the annual LIS system verification in December 2023, not 2024. The Laboratory Director further stated at 11: 15 am, that she did not perform the monthly historical patient creatinine report review for this location for 2024 and 2025. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records and interview with personnel, the Laboratory Director failed to ensure proficiency testing samples are tested as required. Refer to D2009. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, records, and interview with personnel, the Laboratory Director failed to ensure the established quality assessment program was followed to assure the quality of laboratory testing results. Refer to D5891. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An Initial survey was performed on August 16, 2022 at West Jefferson Medical Center-Ridgelake Imaging, CLIA ID # 19D2221312. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 laboratory's policies, personnel records, and interview with personnel, the laboratory failed to establish written policies and procedures to assess competency of the Clinical Consultant. Findings: 1. Review of the laboratory's "Point- of-Care General Policy" under the "Education and Competency In POCT" section revealed the laboratory did not include performance of competency assessment for the Clinical Consultant, to include, but not limited to the frequency. 2. Review of personnel records for the Clinical Consultant revealed a competency assessment for his duties as Clinical Consultant was not performed. 3. In interview on August 16, 2022 at 9:57 am, the Laboratory Director confirmed the laboratory's policies did not include competency assessment for the Clinical Consultant. The Laboratory Director confirmed she did not perform a competency assessment for the Clinical Consultant. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of the laboratory's procedure manual and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's procedure manual revealed the laboratory did not have written policies and procedures that included the monthly laboratory information system (LIS) check. 2. In interview on August 16, 2022 at 11:40 am the Laboratory Director stated the laboratory performs a "Calculated Patient Data Verification" monthly. The Laboratory Director confirmed the laboratory did not include a written procedure in their policy/procedure manual. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to have the policy and procedure manual approved and signed by the Laboratory Director. Findings: 1. Review of the laboratory's policies revealed the policies were maintained electronically and did not include the Laboratory Director's approval/signature. 2. In interview on August 16, 2022 at 9:30 am, the Laboratory Director confirmed she did not sign the laboratory's policies. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of validation records, policies, and interview with personnel, the laboratory failed to include complete performance verification studies for reportable and reference ranges for creatinine testing on the EPOC analyzer. Findings: 1. Observation by surveyor during the laboratory tour on August 16, 2022 at 9:19 am revealed the laboratory utilizes the EPOC analyzer for creatinine testing. 2. Review of the laboratory's "Method Performance Specifications" policy revealed: a) "Reportable Range: The laboratory is responsible for verifying the reportable range of patient test results for each test system. The reportable range includes all results that may be reliably reported and is also called the ANALYTICAL MEASUREMENT RANGE (AMR). The AMR is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or -- 2 of 6 -- other pretreatment not part of the usual assay process." b) "Reference Range (Normal Values): The laboratory must verify that the manufacturer's reference intervals (reference range or normal values) are appropriate for the laboratory's patient population. This may be accomplished by testing an appropriate number of 'normal' donor specimens to verify the manufacturer's claims for normal values; however, a minimum of 20 donors is required. Note: If a formal reference interval study is not possible or practical, as decided by the medical director the laboratory should evaluate the use of published data for its own reference intervals and retain documentation of this evaluation." 3. Review of the laboratory's "Verification of Reportable Range /Linearity" procedure revealed "validate that verified reportable ranges are edited in the instrument, on the report and in the LIS to match the range proven by in-house testing. Place all raw data, graphs and interpretation in binder." 4. Review of the laboratory's validation records revealed the laboratory did not include the following: a) Reportable range to include the actual ranges measured by the laboratory, not the manufacturer's ranges b) Reference range studies 5. In interview on August 16, 2022 at 11:00 am, the Laboratory Director stated the laboratory utilized the manufacturer's reportable range, not the ranges achieved by the laboratory. 6. In further interview on August 16, 2022 at 11:20 am, the Laboratory Director stated the creatinine reference ranges from main campus were adopted by their laboratory. The Laboratory Director confirmed reference range studies or a clinical reference for the reference ranges utilized by laboratory were not included. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's Individualized Quality Control Plan (IQCP), and interview with personnel, the laboratory failed to have a complete IQCP to support the reduction in frequency of quality control for creatinine testing on the EPOC analyzer. Findings: 1. Observation by surveyor during the laboratory tour on August 16, 2022 at 9:19 am revealed the laboratory utilizes the EPOC analyzer for creatinine testing. 2. Review of the laboratory's IQCP documents revealed the laboratory did not include the frequency of performance of the Quality Assessment (QA) monitoring to include, but not limited to " CAP AQ2 proficiency testing, review of quality control, evaluation or errors relating to all phases of testing, evaluation of