Summary:
Summary Statement of Deficiencies D0000 The RLMC Diagnostic Imaging laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the recertification survey performed on July 15, 2026. The following standard-level deficiency was cited: 493.1105 Retention requirements . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) (a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records from one of three PT events completed in 2025 for at least 2 years. Findings are as follows: 1. The laboratory performed moderate complexity Creatinine testing as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 3:05 p.m. on 07/15/26. 2. The laboratory performed Creatinine PT using the College of American Pathologists (CAP) provider. 3. Proficiency testing record retention was required for at least two years as established in the Proficiency Testing procedure found in the StatSensor Creatinine Meter manual. 4. The attestation statement and testing records from the CAP 2025 WBCR-B PT event were not found on date of survey. The laboratory was unable to provide the missing documents upon request. 5. In an interview at 3:35 p.m. on 07/15/26, the LD confirmed the above finding. . 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 --