Summary:
Summary Statement of Deficiencies 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's i-STAT and serum pregnancy procedures and quality control (QC), the laboratory failed to ensure quality control procedures for the i-STAT and serum pregnancy were followed for four of the twelve months for I-Stat troponin, for two of twelve months for i-STAT blood gases and two of twelve months for serum pregnancy. Findings include: 1. Review of the Laboratory's quality control i- STAT policy states "i-STAT quality control performed on every new shipment and monthly". Review of the QC for i-STAT troponin showed the laboratory failed to perform QC on troponin for the months of February 2018, April 2018, August 2018, and December 2018. Review of the QC for i-STAT blood gases showed the laboratory failed to perform QC on blood gases for the months of August 2018 and February 2018. 2. Review of the Laboratory's serum pregnancy policy states "External quality control is run every 30 days and /or with every new lot/shipment whichever comes first". Review of the QC for serum pregnancy showed the laboratory failed to perform QC for the months of April 2018 and May 2018. 3. Interview with general supervisor #1 on January 4, 2019 at 12:30 PM confirmed, the laboratory failed to follow I-STAT and serum pregnancy quality control policies. 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 --