This solicitation amendment is issued to incorporate the following information: " CLARIFICATION - The closing date for offers, contract performance period, price schedule, and evaluation criteria noted in the pre-solicitation notice has been superseded by the information contained in the solicitation, dated 5/28/2015: o The closing date for offers is 6/16/2015, 10:00AM MST; o Pricing shall be submitted for: " Base Year (est. 7/1/2015-6/30/2016) " Option Year 1 (est. 7/1/2016-6/30/2017) " Option Year 2 (est. 7/1/2017-6/30/2018) " Option Year 3 (est. 7/1/2018-6/30/2019) " Option Year 4 (est. 7/1/2019-6/30/2020) o Evaluation criteria shall be as noted in Section E, Exhibit A; " QUESTIONNAIRES - The last day for receipt of all questionnaires from Offeror's references is revised from 9/11 to 9/15/2015; " BACKGROUND INVESTIGATIONS (B/I) - The B/I process is a time-consuming and laborious one, which can take several months to accomplish. Offerors who have completed their investigations for other Federal Agencies and possess the necessary security level called for in the Statement of Work, should include this information in their technical submittals. This does not ensure that an additional B/I will not be required in support of this project, but it may facilitate the process and shorten the timeline. " QUESTIONS & ANSWERS: o May we receive and review the VA-specific standards that will be monitored and audited against? " VHA Handbook 1200.05: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3052 " VHA Handbook 1108.04: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497 " VHA Handbook 1058.01: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2463 o Will 21 CFR Parts 11, 50, 54, 56, 58, 312, 314, 812 and/or 814 regulations be a standard for any of the monitoring or auditing scope of work, as defined in Solicitation Section B.2 Statement of Work Section 7.1? " Yes, particularly those studies within an IND/IDE. o May we review the Quality Assurance Surveillance Plan (QASP) referred to in Solicitation Section B.2 Statement of Work Section 8? " The QASP is an internal document which the awardee and the CSP project manager will address and work with after award. This will allow contractor and customer to come to terms on a Quality Assurance (contractor) / Quality Control (CSP) process for effective oversight and management of the project. o Are there any limitations or requirements for the format of the Solicitation response/proposal with regard to font, margins or length of document? " There are no specific formatting requirements, though preference is 1" margins and Times New Roman font. With regard to the length, you should be thorough in detailing your technical qualifications, but due to the extremely tight timelines for award of a follow-on contract by 7/1, we ask that you be considerate of the time it will take our TEB to review your submittal. o Solicitation Section B.2 Statement of Work Section 7.1 Subtask 1 (focused or specialized Quality Associate visits) and Subtask 2 (routine CRQA visits) are different in nature (audit versus monitoring) and thus would require different skills and knowledge for the personnel conducting these two types of visits. Within the clinical research industry, these two types of visits/persons (auditor versus monitor) bill at significantly different rates (auditor higher than monitor). The solicitation requires a single daily rate for both types of visits on the Attachment 1 Pricing Schedule, but does not provide an estimate of the number/ratio between focused or specialized Quality Associate visits (audits) versus routine CRQA visits (monitoring). What assumptions or further information can be provided by the VA to help the offeror/contractor develop their pricing with regard to these two different types of visits? Perhaps separate pricing schedules can be submitted for the focused or specialized Quality Associate visits (audits) and the routine CRQA visits (monitoring). " These visits are not referring to monitoring services. They are routine audits and focused audits to be performed by an auditor. Questions concerning this solicitation amendment should be directed to [email protected] , with the email subject "VA258-15-R-0471, Auditing Services".

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