Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted from November 8 - 9, 2023. Mass Spec Solutions clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on interview and review of the Quality Control (QC) logs, the laboratory failed to retain QC documents from 10/01/2022 to 02/28/2023. Findings: Review of the QC logs revealed the Temperature Log for the freezers and refrigerators, Room Temp /Humidity log, Eye Wash Station Weekly/Monthly log, Water System Daily Log, and the Temperature Log for the 60 degree oven were missing from 10/01/2022 to 02/28 /2023. On 11/09/2023 at 11:40 AM, the Technical Supervisor stated she did not know where the logs were located. 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 --