Uhealth Pathology At Rmsb

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at UHEALTH PATHOLOGY AT RMSB from December 15, 2025 to December 19, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory report failed to list the correct laboratory name where the testing was performed in the final report or Patient chart for eight out of eight reports reviewed ranging from 02/24/2024 to 11/19/2025. Findings Included: 1-Review of 8 Patient (P) reports for Toxicology on the following dates: P#1 (12/05/2024), P#2 (02/28/2025), P#3 (10/21/2025), P#4 (12/23/2024), P#5 (10/17/2025), P#6 (03-21-2025), P#7 (07-03-2025) and P#8 (11-19-2025) revealed that the final test reports listed a laboratory name that did not match the laboratory name listed on the CLIA certificate of compliance. 2-During phone interview on 12/19 /2025 at 1:30 PM, the General Supervisor admitted that the reports failed to include the correct name of the laboratory that performed the Toxicology testing. 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 D0000 A recertification survey conducted on 01/21/2020 found that Uheatlh Pathology at RMSB clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing policy, proficiency testing (PT) records and laboratory director (LD) interview, the laboratory failed to perform the required twice a year accuracy verification of testing for the quantification of Ketamine, Norketamine, Ritalinic Acid, Tapentadol and Zolpidem tested in urine toxicology for 2 out of 2 years reviewed (2018-2019). Findings include: -Review of Laboratory Procedure Proficiency Testing policy # 3.0.11 revision 3, revealed that on a Note on page 1 the policy stated that " For those tests for which CAP does not require enrollment in PT for clinical test panels, the laboratory must participate at least annually in either external PT or exercise an alternative performance assessment system for determining the reliability of analytic testing." The policy failed to state that the analytes must be verified at least twice a year. -Review of CAP PT menu revealed that no quantification was performed of the analytes: Ketamine, Norketamine, Ritalinic Acid, Tapentadol and Zolpidem. -Review of split samples study revealed that the laboratory performed one split sample evaluation for the quantification of Ketamine, Norketamine, Ritalinic Acid, Tapentadol and Zolpidem in November 2018 and one in November 2019. During an interview on 01/21/2020 at 12: 30 PM, the LD confirmed that the laboratory failed to verify the accuracy for the quantification of the analytes of reference at least twice a year for the years of above reference. 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 --