Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 17, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 the Policy and Procedure manual, and staff interview the laboratlry failed to follow their policy on verifying the Liquid Chromatography- Tandem Mass Spectropmetry (LC-MS/MS) procedures twice a year. Findings: 1. Review of the Policy and Procedure manual for LC-MS/MS the laboratory, states that the laboratory will send split samples out to a CLIA certified laboratory to verify the accuracy of the LC-MS/MS procedures. 2. Review of the LC-MS/MS verification documents, showed that in 2017, the laboratory performed duplicate testing on both of their LCMS-MS analyzers, compairing the results of each analyzer. 3. Interview the Clinic Lab Manager, and staff #2 (CMS form 209), on July 17, at 1 9pm, in the office, confirmed that the procedure verification was performed by running specimens on both of their LC-MS/MS analyzers. 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 --