Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 05, 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: 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 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 policy and procedure manual (SOP) and an interview with the Technical Consultant(TC), the laboratory failed to provide a policy and procedure for performing Urine Analysis on patients. Findings include: 1. SOP document review revealed the laboratory did not have a written policy and procedure for Urine analysis on the Clinitek Status analyzer. The procedure they had for Urinalysis was for the McKesson 120 Urine Analyzer. 2. An interview with the Technical Consultant (TC) on 7/5/2018 at approximately 12:35 PM in the conference review room confirmed there was no written policy on Urine Analysis on the Clinitek Status analyzer in use. 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 --