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1 VETERANS AFFAIRS MEDICAL CENTER, VISN 5 GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) t... 1 VETERANS AFFAIRS MEDICAL CENTER, VISN 5 GENERAL INFORMATION FOLLOWED BY A TENTATIVE STATEMENT OF WORK NOTICE: This is not a solicitation but rather a Request for Information (RFI) (Sources Sought) to determine capability of potential sources and is for information and planning purposes only. Veterans Health Affairs, Network Contracting Office 5, is issuing this request for information/sources sought notice in order to identify capable contractors for the VA Cooperative Studies Program (CSP) Division of VA Research and Development that is responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies in the Department of Veterans Affairs. Responses must be submitted by 12/15/2020 3:00PM EST. Submit responses to the information requested above via email to Jameel.gordon@va.gov. All SDVOSB and VOSB firms that respond shall include proof of CVE certification via www.vip.vetbiz.gov. All small business firms that respond shall include proof of small business status via their Representations and Certifications in accordance with (FAR 4.1102 Policy). While SDVOSB/VOSB contractors are preferred, all capable contractors are welcome to respond to this sources sought notice for market research purposes and shall include as part of their response a brief capability statement that covers the information in the following tentative statement of work. The results of this market research will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., socioeconomic set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses. Tentative/ Statement of Work (SOW) BACKGROUND. The VA Cooperative Studies Program (CSP) is the Division of VA Research and Development that is responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies in the Department of Veterans Affairs. To achieve this mission, The CSP has a clinical research infrastructure that operates under the management of Central Office in Washington, D.C. The CSP is comprised of a CSP Central Office, and professional experts at five data and statistical Coordinating Centers (CSPCCs). The CSP and its coordinating centers in ongoing efforts to ensure regulatory proficiency. utilize the ISO 9001 Quality Management System (QMS) to meet and exceed regulatory and quality requirements. ISO 9001 is a set of standards for quality management systems. The International Standards Organization (ISO) maintains the ISO 9001 standard and approves certification bodies to administered accreditation. SCOPE/OBJECTIVES. The purpose of this procurement is for a Certifying Body (CB) and Registrar to conduct Recertification and Surveillance audits actions under the new International Standards Office (ISO) ISO 9001:2015 standards as it relates to Clinical Trials. It is imperative that any auditor/agency is certified to perform, and has prior experience in Research Clinical Trails audits, preferably with experience in working with the VA. This contract will involve separate recertification/compliance certificates for the five VA Cooperative Studies Program Coordinating Centers (CSP - Boston, Hines, Palo Alto, Perry Point, and West Haven). All five of the CSPCCs are currently registered and are due for recertification, based on the August 2018 new 9001:2015 standards. CSP Boston maintains two geographically separate location, which will incur and additional certification with costs. This process starts in December 2020 when administrative and maintenance fees are due to keep current certifications of the centers, followed up in fiscal year 2021 by in depth initial audits at each of the centers. This is followed by two surveillance audits over the next fiscal years. On a fund s availability basis, the vendor may be requested to provide non-customized training and consultation to any center to achieve certification or conformance on ISO standards audited, this will be requested through the COR to the CO, then to the Vendor. This SOW addresses only ISO 9001:2015, any proposals or bids are based on these established standards and prior experience with Research Clinical Trials. REQUIREMENTS SCHEDULE OF SERVICES AND/OR SUPPLIES. # Description 1 This request is for a multi-year contract (Base Year + Two Option Years) to purchase recertification audit services for ISO 9001:2015. CLIN 1: Perform an ISO 9001:2015 Initial certification Audits to each of the five CSPCCs. To include fees for Administrative, Maintenance, Certificate(s) and travel costs. BASE YEAR: Estimated Dec 2020 through Sep 30, 2021 2 OPTION YEAR ONE: Surveillance Audits of each of the Centers with associated Travel, Maintenance and Administrative costs October 1, 2021 through September 30, 2022 3 OPTION YEAR TWO: Surveillance Audits of each of the Centers with associated Travel, Maintenance and Administrative costs October 1, 2022 through September 30, 2023 ISO AUDIT RESPONSIBILITIES: Government: Provide CSPCC Quality Manual (if there is one) to Vendor prior to audit and other necessary CSP SOPs to prepare for site visits. Provide the Audit Team with opening meeting introduction on Center s function and disclose any unique qualities specific to that Center. A conference workspace, or Teleconferencing capability, for conducting audit interviews with various site employees. Provide escort and badging for the Audit Team when required by local regulations. Provide Lead Auditor yearly with an accurate number of VA CSP personnel at each center, to include vacancies that maybe filled by time of Audit. Include any updates prior to each scheduled audit to assure proper amount of auditor man days are factored in the planning phase of the audit. The centers project the following number of FTE at the time of audit: Center # of FTE Threshold Perry Point 35 26-45 Hines 38 26-45 Palo Alto 47 46-65 Boston 76 66-85 West Haven 40 26-45 Vendor requirements: Certifying Body (CB) Registration Audits: The Vendor shall provide a certifying body auditor (CB auditor) who is experienced with audits of Government Organizations, Clinical Trials and related activities conducted at a clinical trial Coordinating Centers. The CB auditors shall travel to and perform a registration audit and/or surveillance audits at all six Centers for conformance to the designated scope of services for the ISO 9001:2015. The CB auditor shall interview all levels of Center personnel at each location to determine and evaluate the extent of deployment of the Quality Management System, and the Quality Manual. The Vendor will provide the audit schedule at least 30 days prior to the start of the registration audit at the first Center with subsequent schedules delivered at least 30 days before each scheduled audit at the remaining Centers. The CB auditor shall provide an opening meeting to discuss their audit process and address any center questions regarding the audit activities. After the scheduled audit at each Center, the CB auditor shall conduct a closing meeting to summarize results, note difficulties and give at least a draft report with recommendations as part of the closing meeting. When only a draft report is provided at the conclusion of an audit, a final report must be provided to the Center Director and Quality Management Specialist of the Center within one week of the audit. Each Center will have at least 30 calendar days to provide response to any findings. Have the capability to perform teleconferencing to perform Audits, updates and reviews. Currently the preferred VA teleconferencing medium is Microsoft Teams. Surveillance Audits for Option Years One and Two: The Vendor shall conduct surveillance audits annually to certify that each Center continues to comply with the ISO 9001:2015. The Vendor will provide the audit schedule at least 30 days prior to the start of each annual surveillance audit at each CSPCC. The Audit Team shall interview various Center personnel at enough levels to determine and evaluate the extent to which the Quality Management System is implemented, and the Quality Manual. After the audit, the Lead Auditor shall conduct a closing meeting with each Center to summarize results, note difficulties and give a draft report with recommendations. Certifying Body Registration: The registration to be granted shall be subject to the Vendor s determination of the degree to which the Center s Quality Management System is in conformance with ISO 9001:2015. The Vendor shall identify any deficiencies found in the Center s Quality Management System and shall specify a time limit for corrective actions to be implemented. The nature and scope of any reassessment required to maintain full registration shall be explained in detail by the Vendor. The registration shall include as applicable; delivery of Certificates of Compliance to ISO 9001:2015 to each Coordination Center, presentation of camera-ready artwork (hard copy or digital) of the Vendor s registration mark, and those of the Vendor s accrediting agencies for use on CSP documents. The registration shall be valid for a period of three (3) years from the date of issuance and may be withdrawn subject only to each CSP Centers separate or combined request for withdrawal, or Vendor s determination that a Center is not fully compliant with ISO 9001:2015 and applicable ISO requirements during a scheduled surveillance audit. Quality Assurance: The Vendor shall have a defined appeals system through which the Coordinating Centers may appeal any Vendor ruling, determination, action relating to audits, any specific finding, or the registration process. A party independent of both the Vendor and the CSP Center shall render the final adjudication of an appeal. Applicable Documents: The following documents form a part of this specification to the extent noted herein. Unless stated otherwise, the documents shall be the version listed by the number and date from the referenced organization. American National Standards Institute (ANSI) ANSI/ISO/ASQ Q9001:2015 Quality Management Systems requirements. Title 21 Code of Federal Regulations (CFR) Parts 11 (Electronic Records and Electronic Signatures) and FDA, Guidance for Industry Computerized Systems Used in Clinical Investigations, (Electronic Records and Electronic Signatures) and FDA, Guidance for Industry Computerized Systems Used in Clinical Investigations. 21 CFR 50 (Protection of Human Subjects) - elements of informed consent. International Conference on Harmonization (ICH) E6 Good Clinical Practice Section 5, 5.1, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.11, 5.15, 5.21, 5.23. Section 6, 6.1-6.16, Section 8, 8.1-8.4. Reporting Requirements: All written reports and Registration Certificates shall be delivered to the designated COR and specific Center Quality Management Lead. CONTRACT EVALUATION REQUIREMENTS: Accreditations: The Contractor shall be a Certification Body accredited by a recognized Accreditation Body to ISO 17021 (e.g. ASQ National Accreditation Board, or equivalent). The Certification Body must have the following international accreditation codes within the scope of their certification as well as the experience stated below: Public administration: Public administration and defense Health and social work: Human health activities except Hospital activities Registrar shall further be accredited to perform audits and certification of client companies to the ISO 9001:2015. standard. Experience: The Contractor shall have a published directory of companies that have achieved registration or certification to ISO 9001:2015 in conjunction with the Contractor s capability in conducting audits. The Contractor shall have experience with at least one U.S. Government facility, one VA Healthcare system agency, and experience with clinical trials research. The Contractor s Lead Auditor shall have experience with and detailed knowledge of multi-site clinical trials, Contract Research Organizations sponsor level, and regulations as enforced by the U.S. Food and Drug Administration (FDA), including 21 CFR Parts 11 and 50. The complex constraints of Good Clinical Practice (GCP) regulations under both 21 CFR Parts 11 and 50, and ICH 6 make this a critical element for this contract. Contractor shall disclose a complete listing of all auditors that may be assigned to the Audit Team to perform certification audits of the CSPCC s, with a summary of their qualifications. Members of an audit team found not to be acceptable for cause, by a specific center will be replaced by the contractor prior to an audit. SECURITY: The C&A requirements do not apply, and a Security Accreditation Package is not required. GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI). The Vendor will not use GFE or need GFI to perform task identified above. Vendor may use government facilities to conduct report briefings to CSP employees and specified training. OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS. Regulatory expertise in Good Manufacturing Practice: 21 CFR Parts 210 and in parts 211 through 226 and GCP and defined in 21 CFR Parts 11, 50, 54, 56 and ICH Guideline Good Clinical Practice (E6) is required. The Vendor should produce professional certification supporting expertise. Identification of Possible Follow-on Work: The CSP may request Non-customized training to meet the requirements for ISO 9001:2015. This will be done on a task order basis and funds availability through the COR to the CO. Identification of Potential Conflicts of Interest (COI): The current Vendor has worked with the CSP for over nine years. Identification of Non-Disclosure Requirements: The extent of sensitive information disclosed to the Vendor is limited to employee names and VA email addresses. Packaging, Packing and Shipping Instructions: Non-applicable; there will be no materials to ship Inspection and Acceptance Criteria: The COR will be involved in all steps of contract delivery and will verify through review of outputs described with each task. RISK CONTROL. There is no risk involved in the delivery of ISO recertification services or the following surveillance auditing. PLACE OF PERFORMANCE. The onsite audits will occur at the CSP locations in Boston MA (2 locations), Hines IL, Palo Alto CA, Perry Point MD, and West Haven CT. Addresses and Points of Contact provided upon contract award. Development of the schedule and administrative duties will occur at Vendor s site. PERIOD OF PERFORMACE This request is for a multi-year contract (base year + two option years): Base Year: December 2020 through September 30, 2021 Option Year (1) One: October 1, 2021 through September 30, 2022 Option Year (2) Two: October 1, 2022 ending fiscal year on September 30, 2023 DELIVERY SCHEDULE. SOW Task # Deliverable Title Format Number Calendar Days After CO Start 13.1 Initial certification Audit of five CSPCC s QMS to ISO 9001:2015 ISO 17021-Required Format 1 Final report, 1certificate (ISO 9001) for each location Final Report end of 4th Qtr. (FY21) 13.2 Surveillance Audits of the five CSPCC s QMS to ISO 9001 ISO 17021-Required Format 1 Final report, 1certificate (ISO 9001) for each location Final Report end of 4th Qtr. -(FY22) 13.3 Surveillance Audits of the five CSPCC s QMS to ISO 9001 ISO 17021-Required Format 1 Final report, 1certificate (ISO 9001) for each location NLT end of 3rd Qtr. (FY22) *Standard Distribution: One copy of the transmittal letter without the deliverable to the Contracting Officer shall be emailed. ACRONYMS/DEFINITIONS CO Contracting Officer. The Federal employee who is warranted by the Government to enter contracts on behalf of the Government and is the only person authorized to make changes to those contracts. COR Contracting Officer s Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. CSP Cooperative Studies Program CSPCC Cooperative Studies Program Coordinating Center CSPCRPCC Clinical Research Pharmacy Coordinating Center. ISO 9001:2015 The standard for Quality Management Systems. This refers to what the organization does to manage its processes so that its products or services meet the objectives set by the organization, such as: A set of procedures that cover all key processes in the business Monitoring processes to ensure they are effective Keeping adequate records Checking output for defects with appropriate and corrective action where necessary Regularly reviewing individual processes and the quality system itself for effectiveness Facilitating continual improvement Non-customized training is defined as general knowledge and information training about ISO program standards. This type of training can be conducted by the same individual who performs an organizations audit; this is NOT considered a confliction of interest. VAMC Department of Veterans Affairs Medical Center