AN16--New Mexico VA Cooperative Studies Good Clinical Auditing
This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses and Veteran Owned Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) Company Name (b) Address (c) Point of Contact (d) Phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-Owned Small Business, Small Business or Large Business (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below. Responses to this notice shall include the following: (a) Company name (b) Point of contact (c) Phone and email (d) Type of small business, e.g. Services Disabled Veteran Owned Small Business, Veteran-owned Small Business, Small Business or Large Business The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC), located in Albuquerque, New Mexico has a requirement for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Auditing Services. Introduction: This requirement is for a continued need of Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Auditing Services. Background: The New Mexico VA Cooperative Studies Program has a requirement to provide auditing Good Clinical Practice (GCP) CRQA services for the clinical trials conducted by or requested by the VA Cooperative Studies Program (CSP). These trials are conducted at VA facilities and associated non-VA facilities toughout the United States. CSP clinical trials vary over time in number, size and design, but typically consist of 5 to 10 trials that are actively audited each fiscal year. The SMART mandate is to ensure that the clinical trials of the VA CSP are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. SMART accomplishes this task by assuring that VA personnel conducting or supporting clinical trials are trained in GCP and that any compliance problems at participating research sites are identified and resolved tough a program of site CRQA visits. Scope The overall requirement is for tee (3) Clinical Research Quality Associates (CRQA) to perform GCP auditing services. The Contracting Officer may decide to use a Multi-Award versus a single award. Indefinite Delivery/Indefinite Quantity (IDIQ) contract for which the vendor/s shall provide clinical trial site auditing Clinical Research Quality Associate (CRQA) services and Quality Assurance activities. The Contractor/s shall serve as a study Clinical Research Quality Associate (CRQA) and provide services to the VA CSP tough the Site Monitoring, Auditing and Resource Team (SMART) co-located with the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center located in Albuquerque, New Mexico. The tasks include performing site visits, providing post-visit reports, and providing GCP quality assurance support. Services: Clinical Research Quality Associate (CRQA) visits and associated services. The CRQA shall inspect for compliance with the following standards: VHA Directive 1200.05 VHA Handbooks 1108.04, 1058.01, 1907.01, 1200.01, 6500 - VA Information Security Program 45 CFR 46 Protection of Human Subjects 38 CFR 16 (VA Common Rule) Protection of Human Subjects E6 (R2) International Conference on Harmonization (ICH) Guidelines Good Clinical Practice FDA 1572 Guidance FDA Regulations CSP Investigator Guidelines Program level Global SOPs CSP Study Protocol and Operations Manuals SMART SOPs and Approved Methods and Procedures (AMPs) VHA Handbook 1605.05 Business Associate Agreements VA Directive 6500.6 Contract Security VA Directive 6502 Enterprise Privacy Program The CRQA will be required to travel when conducting site visits [CLIN 2] Travel Arrangements and Reimbursement - Travel arrangements shall be the responsibility of the CRQA. Travel costs will be reimbursed in accordance with Federal Travel Regulations (Chapter 300 tough 304) utilizing Government rates. Contractors will be reimbursed for actual travel expenses, but the contractor will use the most economical method of travel available, including non-refundable airfares and mid-range hotels matching government per diem whenever possible. Reimbursable costs include airfare, car rental, hotel, taxis, and meals and incidentals (M&IE). M&IE expenses are included only at the Federal Per Diem Rate. To receive reimbursement, the Contractor shall submit his/her invoices along with travel expense worksheet (which is supplied at the time of award), receipts and all other supporting documents. Documentation to support lowest cost available are required for reimbursement. Travel time is not reimbursable. For site visits requiring travel, port-to-portal travel time should be considered as part of the overall cost of the visit. Contractor (PRIME if there are Subcontractors) will submit all required documents noted above. If travel dates or location are changed at the request of the program, the change fee for new date and/or location will be reimbursed.A No costs will be reimbursed for the convenience of the CRA.A Changes for convenience are the responsibility of the contractor.A Documentation supporting change in location or date/s must come from CSP program officials and /or site staff and must be submitted when invoicing. Task 1 CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTALTRAVEL TIME) [CLIN 1 & 2] Subtask 1a Conduct focused GCP or specialized For Cause Quality Associate Visits - one to four days (INCLUDES TRAVEL TIME) [CLIN 1 & 2] The CRQA shall conduct focused or specialized For Cause QA visits per the SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. These visits may require travel with less than 24-hour notice. In the case of For Cause visits the site is not notified of the visit. The CRQA must be able to conduct these visits in the timeframe required by CSP Director or Program Leadership. The CRQA may be required to lead a team of CSP staff that assist in conducting the site visit. The CRQA shall conduct focused or For Cause site visits per SMART SOPs to inspect VA investigators research study for compliance with GCP and with VA and CSP research policies. In conducting these sites visits, the CRQA shall: Provide CSP Director and SMART leadership staff immediate feedback of significant discoveries made during site visits Assess site for key area/s of focused audit Assess site for key area/s of For Cause Audit Assess effectiveness of interactions between the investigator site study team and the CRQA and other representatives of CSP Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices Know and comply with VA Privacy and Data Security Policy during site visits Prepare reports after each inspection for CSP Director and SMART, citing opportunities for improvement (OFIs) and providing recommendations for correcting problems and improving practice in the time required by the CSP Director Subtask 1b Conduct routine Quality Associate Visits - one to four days (with pre and post work, (INCLUDES TRAVEL TIME) [CLIN 1 & 2] The CRQA shall conduct periodic routine CRQA visits per the SMART Standard Operating Procedures (SOPs) to inspect VA investigators for compliance with GCP and with VA and CSP Research policies. Frequency of Visits The frequency and timing of CRQA visits will be determined by SMART Staff Leadership for each site based on the following: Lead CRA and Study Team recommendations Subject accrual rate at the site Total number of subjects to be enrolled at the site Complexity and risk level of the study protocol Data collection and record keeping proficiency at the site Observations and corrective actions from previous monitoring visits Subtask 1c Preparing for site visits [CLIN 1] Scheduling After approval of planned visit by auditing study Lead, the CRQA shall coordinate visit dates with site Study Coordinator and Site Investigator. The CRQA will request current contact information and mailing address. The CRQA shall contact the site coordinator to set up a date/time for the visit and to discuss: Tentative Agenda Estimated time needed on site with the Site Investigator/Coordinator Specific documents needed for review After CRQA has set up a date/time for the visit, the CRQA shall submit a request to the SMART Program Manager (PM) email group for a site announcement letter using the provided email template. The SMART admin staff is responsible for sending the announcement letters to site and study personnel in accordance with the correspondence distribution table. Documents and resources Prior to the CRQA visits, the CRQA shall assemble all documents and resource materials needed to conduct the visit (i.e., correspondence, previously completed monitoring documents, etc.). Visit will be conducted following the SMART Routine Audit Plan. Subtask 1d Conducting site visits [CLIN 1] In conducting these sites visits, the CRQA shall: Review subject and investigator study records for compliance with GCP, VA and CSP research policy Check for study protocol compliance Review Essential Documents Binder (EDB) Conduct Informed Consent and HIPPA review Conduct participant data review Verify Case Report From (CRF) data against Source documents Review source documents for Adverse Events (AE)/Serious Adverse Events (SAE) Review electronic medical record for unidentified SAEs Review CRFs for accuracy and legibility Check for CRF submission to Data Coordinating Center Know and comply with VA Privacy and Data Security Policy during site visits Provide CSP Director and SMART Staff Leadership immediate feedback of significant discoveries made during site visits Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices Assess effectiveness of interactions between the investigator site study team and the CRQA and other representatives of CSP Determine follow-up actions to be taken Provide relevant GCP training and re-education as needed Conduct exit interview with study team to discuss site status Subtask 1e Prepare site visit reports and summary letters [CLIN 1] Within fourteen calendar days (or current SOP requirement) of last day on site of site visit, the CRQA shall complete a site visit report, Summary for Investigator and applicable attachments (using pre-approved templates) and provide these documents to the SMART PM group by posting to SMART SharePoint site or other location as directed by SMART leadership. Provide all QA visit logs and scanned documents related to site visit to SMART and Auditing CRQA study lead for review, follow-up and finalization. QA activities performed include: Summary of findings, conclusions, and any actions taken or planned to correct any deficiencies noted during the visit All documents must be submitted in the specified electronic format using the required templates. Content must be understandable by SMART staff, site staff and CSP study personnel. Content shall be grammatically correct, and content verified for accuracy. Inform the SMART Lead CRQA of recurrent and/or serious compliance deficiencies Assist with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency The CRQA shall communicate with and provide follow up with the study lead CRQA to answer all questions and issues prior to visit report approval and Summary for Investigator distribution to the intended recipients within current SOP/AMP requirement. Subtask 1f Audit Report Follow-up and Resolution [CLIN 1] Once the investigator correction action response has been received from the site the Sponsor s Designated Representative (SDR) evaluates the corrective action response for acceptability and completeness. The SDR ensure the Site Investigator response is acceptable and complete by: Reviewing and evaluating the Site Investigator s written response Discussing the findings and specified actions with site personnel and Study Leadership as needed Maintaining the secure CSP audit file of documents and correspondence. Consulting, as needed, with the appropriate CSP Coordinating Center Project Manager, QA Nurse Specialist or designee to assist site personnel in resolving issues raised in the SMART audit report. Documents resolution and closeout of site visit Task 2 CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) [CLIN 1 & 2] Subtask 2a Support of another CRQA conducting CRQA visits - one to four days on site The CRQA may support another CRQA in conducting site auditing visits at the request of the Lead CRQA or SMART Leadership Subtask 2b Support of study kickoff, annual, program meetings or training - one to four days on site The CRQA may attend or present at study kickoff meetings, annual meetings or other meetings at the request of the Lead CRQA or SMART Leadership The CRQA may attend in house training or perform QA tasks at the CRPCC in Albuquerque, NM. Task 3 - GCP Quality Assurance (QA) support to the VA Cooperative Studies Program, Hourly; no travel required [CLIN 3] Subtask 3a Create site visit tools Subtask 3b Develop GCP tools for use by participating sites Subtask 3c Design data from casebooks for organizing patient files at investigative sites Subtask 3d Develop requirements, procedures and guidance for source documentation of key study data within each trial Subtask 3e Remote Records Review (not related to the review required for visits with pre and post activities) Subtask 3f Study Orientation Subtask 3g Completion of training required by the Department of Veterans Affairs, VA CSP and SMART Subtask 3h Other QA activities as assigned (i.e., Serve as the Sponsor s Designated Representative (SDR) for the review of reports received from the site auditors The SDR shall finalize and approve reports prior to distribution. The SDR shall complete the site visit portion of the SDR form. The SDR shall submit a request to the SMART Program Manager (PM) email group for a site visit follow up letter using the provided email template. The SMART admin staff is responsible for sending the announcement letters to site and study personnel in accordance with the correspondence distribution table. The SDR shall review site visit response, verify actions, communicate with site staff and site auditor prior to approving response and submitting response and SDR form to close out study visit. Lead CRQA will submit a request to the SMART Program Manager (PM) email group and provide documentation of completion using current business process and forms. The SMART admin staff is responsible for filing required documents in accordance with the SMART SOPs/AMPs. Identification, Parking, Smoking, and VA Regulations: The Contractor's FSEs shall wear visible identification issued by VAHCS Police Section at all times while on the premises of VAHCS. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. VAHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at VAHCS. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court. Information Security: In accordance with Appendix A, Handbook 6500.6 Checklist blocks 7, the C&A requirements do not apply to this requirement, and Security Accreditation Package is not required. The nature of this requirement is technical; however, there is no information to be protected. PHI/PII Protected Health Information/Personally Identifiable Information: PHI/PII is any information about an individual maintained by an agency, including (1) any information that can be used to distinguish or trace an individual s identity, such as name, social security number, date and place of birth, mother s maiden name, or biometric records; and (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information. CRQAs will have access to PHI/PII data during performance of the tasks stated in this Statement of Work. CRAs must know and comply with VA Privacy and Data Security Policy during site visits and properly protect this information. Other Pertinent Information or Special Considerations: Contracting Officer s Representative To be determined Period of Performance: Base Year September 1, 2020 August 31, 2021 Option Year 1 September 1, 2021 August 31, 2022 Option Year 2 September 1, 2022 August 31, 2023 Option Year 3 September 1, 2023 August 31, 2024 Option Year 4 September 1, 2024 August 31, 2025 Qualifications/Technical Abilities/Degrees Required of Individual Contractors or Employees/Sub-Contractors of a Prime Who Performs Work on this Contract: Hold a bachelor s degree or be a Licensed Health Care Provider, and Have five years or more research monitoring or auditing experience with multi-center clinical trials, and GCP trained (documentation of completed courses provided by nationally recognized training providers, e.g., Barnett International, ACRP), and Past Performance/Experience/Work History: Medical record and clinical chart review, and Computer knowledge - Skilled in Microsoft Office Programs (e.g., Outlook Email, Word, PowerPoint, Excel and SharePoint), and Adobe Acrobat Professional Certifications/Degrees/training DESIRED of individual contractors or employees/sub-contractors of a prime who performs work on this contract: Health care-related field bachelor s degree in science or advanced degree (e.g. Pharm.D.) At least ten (10) years of experience providing Good Clinical Practice (GCP) Quality Assurance (QA) services At least five years experience delivering GCP QA service to federally-funded research with special consideration given to actual experience monitoring or auditing at VA research sites including documented ability to work accurately with various Government computer systems to retrieve veterans records for analysis. Certified as a Clinical Research Associate (CRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body Specific training or certification in auditing of clinical research or clinical trial quality assurance (documentation of completed a courses or certification provided by nationally recognized training providers, e.g., Barnett International, University of North Carolina, etc.) Performance Monitoring: Refer to the Quality Associate Surveillance Plan (QASP). Security Requirements: All Contractor employees who require access to the Department of Veterans Affairs' computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Law Enforcement Training Center/SIC. The level of background security investigation will be in accordance with VA Directive 0710 dated June 4, 2010 and is available at: http://vaww.va.gov/vapubs (VA Handbook 0710, Appendix A, Tables 1 and 2). Appropriate Background Investigation (BI) forms will be provided upon contract (or task order) award and are to be completed and returned to the VA Law Enforcement Training Center/SIC within 30 days for processing. Contractors will be notified by VA Law Enforcement Training Center/SIC when the BI has been completed and adjudicated. These requirements are applicable to all Contractor personnel requiring the VA computer access. If the security clearance investigation is not completed prior to the start date of the contract, the employee may work on the contract while the security clearance is being processed. However, the investigation must be completed / approved before any site visits are conducted. The Contractor shall be responsible for the actions of those individuals they provide to perform work for the VA. If damage arises from work performed by Contractor personnel, under the auspices of the contract, the Contractor shall be responsible for resources necessary to remedy the incident. The investigative history for Contractor personnel working under this contract shall be maintained in the databases of either the Office of Personnel Management (OPM) or the Defense Industrial Security Clearance Organization (DISCO). Should the Contractor use a vendor other than OPM or Defense Security Service (DSS) to conduct investigations, the investigative company must be certified by OPM/DSS to conduct Contractor investigations. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including date of occurrence and data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code. Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected. Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text. Amount of time the data has been out of VA control. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons). Known misuses of data containing sensitive personal information, if any. Assessment of the potential harm to the affected individuals. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification, one year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports, data breach analysis, fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution, one year of identity theft insurance with $20,000.00 coverage at $0 deductible; and necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. The contractor is required to report any Information Security or privacy breach, loss of data, inappropriate access immediately to contracting officer representative for this contract (COR), relevant facility Information Security Officer relevant facility Privacy Officer - noting details of breach circumstances, necessary remediation/corrective action as required under HIPAA regulations. The C&A requirements do not apply, and a Security Accreditation Package is not required. Position Sensitivity: The position sensitivity impact for this effort has been designated as LOW RISK. Background Investigation: The level of background investigation commensurate with the required level of access is NATIONAL AGENCY CHECK WITH WRITTEN INQUIRIES (NACI) (cost is approximately $230). Government-Furnished Equipment (GFE) AND/OR Government-Furnished Information (GFI) Contractor furnished: The CRQA shall provide all equipment and supplies necessary to perform the contract requirements as set forth in the Request for Proposal (RFP). The CRQA s reporting requirements will necessitate literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint, as well as Internet capability to send and receive faxes, electronically transmit documents, access email and correspondence, ability to communicate during travel and securely access, store and destroy sensitive documents. Computer access must be maintained following VA regulations. CRQA shall maintain VA Computer access and ensure computer and program functionality prior to audit. Government furnished: A laptop computer with Microsoft Office Programs, e.g., Word, Excel, PowerPoint, SharePoint pre-installed and PIV card shall be provided by the Government for use in providing the CRQA services (use of this government-furnished laptop for all work for SMART contract services is mandatory). Place and hours of Performance The Contractor will be required to perform work at different sites (hospitals and/or clinics) toughout the United States and territories, at the Contractor s place of business and at the SMART office in Albuquerque, New Mexico. The Contractor must be available by phone during business hours (8:00 am to 5:00 pm/MST) Monday tough Friday. There may be times when the Contractor will need to be available beyond business hours in the case of a For Cause, special circumstance or unannounced audit. It is essential that the Contractor be able to promptly respond to the needs of the SMART, i.e., be able to report within 24 hours to the SMART Office or to the VA research facility where visit will be conducted. SMART and CSP program leadership reserves the right to accompany the Contractor on site visits or to visit and inspect the Contractor s place of business at reasonable times during normal business hours. Federal Holidays observed are: New Years' Day Labor Day Martin Luther King Day Columbus Day Presidents' Day Veterans' Day Memorial Day Thanksgiving Day Independence Day Cistmas Day Training & Additional Guidance All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Privacy and Information Security and Rules of Behavior training in TMS and annually complete required security training; Successfully complete the appropriate VA privacy training in TMS and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time the training and documents are complete. Records Management Contractor will adhere to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information. Invoicing The CRQA will invoice for services rendered and expenses incurred utilizing the invoice template, travel expense and professional service worksheets and training supplied at the time of award. When the CRQA is a subcontractor, the primary contract holder is responsible for the review, approval and submission for payment of all invoices submitted to the SMART PM group (ABQCSPSMART-PM@va.gov) under their contract. All communications regarding invoicing from a subcontractor shall be directed tough the primary contract holder. Invoices should be submitted only after all QA services are complete and all associated QA documents are submitted. After SMART PM approves the invoice, the contractor will submit the final invoice as directed in the contract (typically via Tungsten Network). IMPORTANT INFORMATION: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice does not commit the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will be restricted to this information to match information to a possible solicitation. Public Law 109-461 mandates the VA to consider a total set-aside for Service-Disabled Veteran Owned Small Business set aside. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. There is no anticipated sub-contracting opportunity for this procurement. Notice to potential offerors: All offerors must have an active registration in the System for Award Management (SAM) at www.sam.gov before responding to any Government inquiry. Additionally, all Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who plan to submit an offer must have an active registration with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. Please contract Sheri Eiri, Contract Specialist at sheri.eiri@va.gov. All responses must be received in writing no later than Friday, December 20, 2019.
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