H166--Pharmaceutical Aseptic and Environmental Testing & Analysis

Pharmaceutical Aseptic and Environmental Testing and Analysis | Q & A: Q: On Page 63, it mentions that quoters are expected to inspect the site where services are to be performed. Is this a requirement for being awarded the contract and if so, would we just be expected to visit the Salisbury VAHCS pharmacy location prior to preforming the analyses listed? A: The contracted lab would NOT inspect SVAHCS sites nor would they be permitted. This would change only if we engaged in a contract whereby the services included providing the physical sampling of environments and compounding personnel this level of service is not being requested at this time. Q: On Page 4, (1.2) it mentions that the contractor shall be licensed and insured to provide services in the area covered and includes certifications as Medical Laboratory Scientists by the ASCP as an example. Are any or all scientists working on the samples in this solicitation required to be licensed as a Medical Laboratory Scientist (or equivalent)? A: The lab staff working with the samples do not have to be Medical Laboratory Scientists since the samples are not being evaluated for medical/clinical purposes, but they certainly can be. Our local lab staff recommend the external lab should at a minimum meet OSHA standards and be accredited by the National Environmental Laboratory Accreditation Program (NELAP), a non-profit organization that develops national consensus standards for environmental laboratories. These accrediting bodies validate labs adhere to ISO/IEC 17025:2005 general requirements for the competence to carry out tests and/or calibrations, including