Summary:
Summary Statement of Deficiencies D0000 The following deficiencies were cited as the result of a recertification survey completed on 02/04/2021 for 42 CFR part 493 Laboratory Requirements. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and interview with the Technical Supervisor, the laboratory failed to ensure that chemical safety protocols were established and followed in regards to the storage of chemical reagents in the laboratory. Findings are: A. During observation on 02/04/2021 at 10:30 am, the surveyor noticed a 4 Liter, amber glass, Sigma Aldrich bottle of 2-Propanol (molecular grade ethanol widely used in laboratories) sitting on the bottom shelf in the Post Amplification Room. 1. The 2- Propanol bottle was labeled with an open date of 5/14/2018. There was no expiration date indicated by the manufacturer or the laboratory. B. During interview on 02/04 /2021 at 10:30 am, the Technical Supervisor was asked if the laboratory had a place to keep all their chemical/flammable reagents such as a safety chemical cabinet that is fire resistant. She stated that they did not have one in the Post Amplification Room and that the 2-propanol was only being used for cleaning purposes. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of