AN12--IDIQ Monitoring Services Extend due date. Add SOW information. Additional vendor questions and answers.
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E21Q0041 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect tough Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 541611 Administrative Management and General Management Consulting Services with a small business size standard of $16.5M. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of best value to the government. Statement of Work Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services This requirement is for a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract to provide Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) Monitoring Services. Background: The Department of Veterans Affairs, Cooperative Studies Program (CSP), Site Monitoring, Auditing and Resource Team (SMART) requires an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for Good Clinical Practice (GCP) Clinical Research Quality Associate (CRQA) monitoring services for clinical trials conducted by or requested by CSP. These trials are conducted at VA facilities and associated non-VA facilities toughout the United States and vary over time in number, size, and design. At any given time, CSP will have approximately 25 trials conducted at 300 to 400 investigative sites in various stages of activities (planning, on-going, closeout) but typically only 5 to 10 trials are actively monitor each fiscal year. SMART, co-located with the CSP Clinical Research Pharmacy Coordinating Center (CSPCRPCC) in Albuquerque, New Mexico and tenant to the New Mexico Veterans Affairs Health Care System (NMVAHCS) is responsible for ensuring VA CSP clinical trials are conducted in compliance with the scientific and ethical principles embodied in the GCP regulations and guidelines. SMART accomplishes this task by training VA personnel conducting/supporting clinical trials are trained in GCP and identifying any compliance problems at participating research sites and resolved tough a program of CRQA site visits (both on-site and virtual/remote off-site monitoring techniques are utilized). The VA SMART program does not have the required manpower authorized or assigned to support the full workload and relies on experienced contractors to provide support. This requirement is a follow-on to a current contract for like services. Scope: The Contractor shall provide services under an IDIQ contract for Clinical Research Quality Associate (CRQA) services to the Site Monitoring, Auditing and Resource Team (SMART). The tasks include performing on- and off-site visits, providing post-visit reports, and providing GCP Program Quality Support (PQS) following SMART guidelines. Additionally, if requested, the contractor will identify to SMART, a monitor to fulfill the role of a Lead CRQA for a specific study. This Lead will coordinate the overall study monitoring plan and associated activities under the direction and supervision of the VA Employed Chief of SMART Monitoring. Specific Tasks: The contractor shall provide Clinical Research Quality Associate (CRAQ) visits and associated services as requested by the VA SMART Program. The contractor shall inspect a clinical trial site using a clinical trial specific monitoring plan developed and provided to the contract monitor by the Chief of SMART Monitoring or designee. These inspections can be off-site (remote review of key critical data) or on-site (in-person or virtual equivalent). The monitoring plan will be compliant with the following standards (or as amended / deleted by the government) which the contract monitor is expected to have familiarity: VHA Directive 1200.1 Research and Development Committee VHA Directive 1200.5(1) Requirements for the Protection of Human Subjects in Research VHA Handbook 1108.04 Investigational Drugs and Supplies VHA Handbook 1058.01 Research Compliance Reporting Requirements VHA Handbook 1907.01 Health Information Management and Health Records 45 CFR 46 Protection of Human Subjects 38 CFR 16 Protection of Human Subjects - (VA Common Rule) ICH E6 (R2) International Conference on Harmonization (ICH) Guidelines Good Clinical Practice FDA Regulations (e.g. 21 CRF 312 Investigational New Drug Application; 21 CFR 812 FDA Form 1572 requirements and guidance CSP Investigator Guidelines CSP Program level Global Standard Operating Procedures (SOPs) CSP Study Protocol and Operations Manuals SMART SOPs and Approved Methods and Procedures (AMPs) Service requirements consist of the following which are explained in further detail in the requirements TASK 1 In-Person (or Virtual Equivalent) Site Visit TASK 2 Travel associated with performing an In-Person Site Visit TASK 3 GCP Program Quality Support (PQS) including Off-Site Visits The contractor shall be required to conduct off-site remote / virtual visits and to travel to conduct on-site visits. Travel arrangements shall be the responsibility of the contractor for on-site visits. Travel expenses 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 rates 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 to SMART focal point. Documentation to support lowest cost available is required for reimbursement. Travel time is not reimbursable. For on-site visits requiring travel, portal-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 however no expenses will be reimbursed for changes made for the convenience of the CRQA.A Changes for convenience are the responsibility of the contractor. Documentation supporting change in location or dates must come from CSP program officials and /or site staff and must be submitted when invoicing. 3.1 Task 1 CRQA visits with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) The contractor shall conduct site initiation visits as defined by the CRQA Monitoring Plan and SMART Standard Operating Procedures (SOPs) with the support of the Lead CRQA. The visits shall be scheduled after the Investigator s Meeting. When conducting a site initiation visit, the CRQA shall perform an evaluation as specified in the CRQA Monitoring Plan that will include at least the following, and additional items as relevant to the design of the trial: Protocol procedures including inclusion/exclusion criteria Subject informed consent process Screening procedure Randomization procedure Investigational Product Accountability Unanticipated Adverse Event reporting and Serious Adverse Event Reports Source document review and verification Current requirements and availability Case Report Form (CRF) completion, correction, QA procedures Institutional Review Board (IRB) policies and procedures (i.e., adverse events and protocol deviations) Regulatory and other study document completion and maintenance Site correspondence with sponsor, CRQA and maintenance Un-blinding procedures of a blinded study Other related protocol procedures The contractor shall assure the following regulatory information is present in the site files: Current IRB approval protocol/amendments Current IRB approval consents(s) Current IRB membership list or documentation of IRB compliance Investigator agreements Financial disclosures Investigator curriculum vitae (CV) Research and indemnity (if applicable) agreement All training requirements GCP, Health Insurance Portability and Accountability Act (HIPAA) and Human Subjects Protections (HSP) Additionally, the contractor shall ensure the following Study Management Documents are completed (if applicable) and appropriately filed in the Essential Document Binder (Regulatory Binder): Delegation of Authority Form or CRF Authorization Log IRB policy and procedures (i.e., adverse event and protocol deviation reporting) IRB correspondence Sponsor correspondence Study contact list Subject list Site Visit Log CRFs (all versions) CVs 3.1.1 Subtask 1a Conduct Routine Monitoring Visits - one to four days (with pre and post work, (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) The contractor shall conduct periodic routine visits per the CRQA Plan and 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 contractor visits will be determined by SMART Leadership for each site based on the following: Lead CRQA 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 3.1.2 Subtask 1b Preparing for site visits Scheduling After approval of planned visit by monitoring study Lead, the contractor shall coordinate visit dates with site Study Coordinator and Site Investigator. The contractor will request current contact information and mailing address. The contractor 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 the contractor has set up a date/time for the visit, the contractor shall submit a request to the SMART Program Manager (PM) email group for a site announcement letter using the provided email template. Documents and resources Prior to the contractor visits, the contractor 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 studies Integrated Monitoring Plan. 3.1.3 Subtask 1c Conducting site visits In conducting these sites visits, the contractor 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 contractor 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 Notify the Lead CRQA and SMART of recurrent and/or serious compliance deficiencies immediately of becoming aware of such deficiencies Assist during and after the visit as necessary with development and implementation of Corrective Actions and/or Preventive Actions (CAPAs) to mitigate recurrence of compliance deficiency 3.1.4 Subtask 1d Prepare site visit reports and summary letters Study specific templates are provided to the monitor upon assignment of study training and visit. Within ten calendar days (or current SOP requirement) of last day on site of site visit, the contractor shall complete a site visit report, Summary for Investigator and applicable attachments (using provided templates), and provide these documents to the SMART PM group by posting to SMART SharePoint site or other location as directed by SMART leadership. See Section 4. Deliverable Schedule. Provide all QA visit logs and scanned documents related to site visit to SMART and Monitor contractor 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 study lead monitor 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 contractor shall communicate with and provide follow up with the study lead monitor 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. The contractor shall upload QA documents to the SMART portal which includes reports and follow-up summary letter. All reports and letters will be grammatically correct and sent to the SMART in the specified electronic format. 3.2 Task 2 CRQA Visits without pre and post work (INCLUDES PORTAL-TO-PORTAL TRAVEL TIME) 3.2.1 Subtask 2a Support of another CRQA conducting CRQA visits - one to four days on site (or Virtual Equivalent) The CRQA may support another CRQA in conducting site Monitoring visits at the request of the Lead CRQA or SMART Leadership. For example, this may include providing support to the lead monitor during a site visit, most often during a monitoring visit, or training as a new monitor on conducting site visits.A The supporting monitor is not responsible for the pre work such as scheduling visits, pre visit log reviews, developing special tools for the visit, or any of the post work such as visit summary, visit report, summary attachments or post monitoring communication between site and lead. In summary support of another monitor - requires no pre or post work but does include travel and actions conducted at the site. Subtask 2b Support of study kickoff, annual, program meetings or training - one to four days on site (or Virtual Equivalent) The contractor may be required to attend or present at study kickoff meetings, annual meetings or other meetings at the direction of the Lead study monitor or SMART Leadership The contractor may be required to attend in-house (or Virtual Equivalent) training or perform PQS tasks at the direction of the SMART Leadership. 3.3 Task 3 GCP Program Quality Support (PQS) to the VA Cooperative Studies Program Hourly; no travel required 3.3.1 Subtask 3a Create site visit tools 3.3.2 Subtask 3b Develop GCP tools for use by participating sites 3.3.3 Subtask 3c Design data from casebooks for organizing patient files at investigative sites 3.3.4 Subtask 3d Develop requirements, procedures and guidance for source documentation of key study data within each trial 3.3.5 Subtask 3e Off-Site records review of key critical data in support of risk-based integrated monitoring. Does not include off-site record review related to the preparation for CLIN 1 & 2 On-site (or virtual equivalent) Visits with Pre and Post Activities . This subtask includes but is not limited to: Conduct Informed Consent and HIPPA review Review of the Electronic Health Record (HER) for eligibility and protocol/regulatory compliance Review of the electronic date capture system (EDC), CRF completion, correction, QA procedures Review for study endpoints or primary outcomes data Review for safety (unanticipated adverse event reporting and serious adverse event reporting) Determine follow-up actions to be taken. 3.3.6 Subtask 3f Study Orientation 3.3.7 Subtask 3g Completion of training required by the Department of Veterans Affairs, VA CSP and SMART 3.3.8 Subtask 3h Serves as the Sponsor s Designated Representative (SDR) 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 SDR shall review site visit response, verify actions, communicate with site staff and site monitor prior to approving response and submitting response and SDR form to close out study visit. Lead contractor will submit a request to the SMART Program Manager (PM) email group and provide documentation of completion using current business process and forms. 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 Monitor 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 Monitoring report. Documents resolution and closeout of site visit Deliverable Schedule The contractor shall deliver the following as stated in the table below: SOW Task Deliverable Description Due Date Electronic submission to: Task 1 See subtasks See subtasks See subtasks Subtask 1a Site Initiation Visits Site Initiation final report, investigator summary and supporting documents Site Initiation 10 calendar days from last day of visit unless otherwise required by CSP Director SMART Leadership, SMART PM Subtask 1b Routine Monitoring Visit final report, investigator summary and supporting documents Routine Monitoring 10 calendar days from last day of visit unless otherwise required by CSP Director SMART Monitoring Lead SMART PM email group ABQCSPSMART-PM@va.gov Subtask 1c Schedule as directed by SMART Leadership and submit a request to the SMART Program Manager (PM) email group for a site announcement letter (See Attachment D-Announcement Letter) 30 days prior to visit but no later than 14 days. SMART Monitoring Lead SMART PM email group ABQCSPSMART-PM@va.gov Subtask 1c Contractor shall assemble all documents and resource materials needed to conduct the visit according to monitoring plan and save documents received from site coordinator Prior to first day of visit SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1d Perform monitoring visit During visit dates SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1e The contractor shall finalize and provide logs, site visit report, Summary for Investigator and applicable attachments Within ten calendar days (or current SOP requirement) of last day on site of site visit SMART Monitoring Lead SMART PM SMART SharePoint site, URL https://www.csp.va.gov/smart/SitePages/Home.aspx Subtask 1f Monitoring Report Follow-up and Resolution By requested date SMART Monitoring Lead SMART PM Task 2 See subtasks See subtasks See subtasks Subtask 2a Services provided to support another contractor visit completion By requested date SMART Monitoring Lead SMART PM - Subtask 2b Support services provided By requested date SMART Monitoring Lead SMART PM Task 3 See subtasks See subtasks See subtasks Subtask 3a Site tools submitted By requested date SMART Monitoring Lead SMART PM Subtask 3b GCP tool/s submitted By requested date SMART Monitoring Lead SMART PM Subtask 3c Design data submitted By requested date SMART Monitoring Lead SMART PM Subtask 3d Documents submitted By requested date SMART Monitoring Lead SMART PM Subtask 3e Off-Site Records By requested date SMART Monitoring Lead SMART PM Subtask 3f Documentation of completed study orientation Upon completion of training, no later than due date of training requirement. SMART PM email group ABQCSPSMART-PM@va.gov Subtask 3g Documentation of completed training Upon completion of training, no later than due date of training requirement. SMART PM email group ABQCSPSMART-PM@va.gov Subtask 3h Properly completed and submitted SDR review activities of visit reports and documents Post Visit Properly completed and submitted SDR review activities of visit reports and documents Post Site Response Due 30 days from last date of visit or current SOP requirement. Due as determined by Director of SMART SMART Monitoring Lead SMART PM ABQCSPSMART-PM@va.gov Task 4 Successfully complete the appropriate training courses in TMS Before being granted access to VA info and systems and annually thereafter ABQCSPSMART-PM@va.gov COR Task 5 Submit expenses incurred utilizing the invoice template, travel expense and professional service worksheets and training supplied at the time of award. Invoices should be submitted in VIS Within 30 days of visit. And after all QA services are complete and all associated QA documents are submitted. Within 30 days of visit and after SMART PM approves the invoice, the contractor will submit the final invoice as directed in the contract ABQCSPSMART-PM@va.gov Note -All communications regarding invoicing from a subcontractor shall be directed tough the primary contract holder. If for any reason a deliverable cannot be delivered as scheduled, the contractor shall notify the COR tee business days prior to the due date. This notice must include the reason(s) for the delay, and the impact on the overall project. 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 that is linked or linkable to an individual, such as medical, educational, financial, and employment information. The CRQA will have access to PHI/PII data during performance of the tasks stated in the Statement of Work. CRQA must know and comply with VA Privacy and Date Security Policy during site visits and properly protect this information. Other Pertinent Information or Special Considerations: In accordance with VHA Directive 1192.01, SEASONAL INFLUENZA VACCINATION PROGRAM FOR VHA HEALTH CARE PERSONNEL, contractor personnel performing direct services requiring physically visiting medical facilities must meet annual flu shot requirements.A Contractors are expected to follow the stated guidance and provide the SMART Program Manager and COR the required documentation. Failure to comply could result in the individual not allowed to perform work on VA facilities. Period of Performance: Ordering Period 1 April 17, 2021 April 16, 2022 Ordering Period 2 April 17, 2022 April 16, 2023 Ordering Period 3 April 17, 2023 April 16, 2024 Contractor Qualifications: The contractor, contractor s employees, sub-contractor and individuals who will perform work under this contract must meet all the qualifications listed below and submit copies of documents requested below to meet contractor qualifications. Statements such as certificates available up request is cause for rejection of the proposal if the requested documents for all individuals named in the proposal are not provided with the submission. When it is the intent of the contractor to add additional staff after contract award, SMART reserves the right to review the qualifications of and reject proposed additional staff who do not meet the qualifications. Current Curriculum Vitae (CV) or detailed resume. Documentation of a Bachelor s degree (BA/BS) in a scientific or health-related field or licensure as health care provider, (e.g., RPh, RN, MD, DO, PA CNP, etc.), or advanced degree in health-related or clinical research-related field (e.g. Pharm.D., Masters, Ph.D.) OR Certified as a Clinical Research Associate (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Acceptable documentation: copies of degree certificate, transcripts showing awarding of degree, copy of licenses, certification certificate. Documentation of completed Good Clinical Practice training provided by nationally recognized training providers (e.g., Barnett International, ACRP, CITI, CFPA). Acceptable documentation: training certification certificate. Documentation of Specific training or certification in monitoring of clinical research trials and documentation in human subjects protection (HSP), provided by a nationally recognized training providers, e.g., Barnett International, ACRP, CITI, CFPA, University of North Carolina, etc., OR certification as a Clinical Research Associate, (CCRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body. Clinical trial auditing training or experience is given added consideration. Acceptable documentation: training certification or certification documents OR if clinical trial monitoring training is all on-the-job (OJT) the contractor shall provide a listing of the specifics for each individual clinical trial, duration of the work on the clinical trial and frequency of monitoring visits, disease state monitored. Documentation of a minimum of ten (10) years providing Good Clinical Practice (GCP) clinical trial monitoring specifically of clinical research sites. Additional consideration given to monitoring of multi-site clinical trials as well as auditing of clinical trials. Acceptable documentation: Experience should be documented in the current Curriculum Vitae or detailed resume of each names monitor in the submission. Documentation of a minimum of five (5) years experience providing GCP monitoring (or auditing) services for federally funded research with additional consideration to delivery of these servicers to VA funded/sponsored clinical research trials. Monitoring at a VA clinical trial site for a commercial study-sponsor does not qualify as monitoring or auditing of federally funded research. Acceptable documentation: Provide, for each of the proposed monitors, a listing of the trial sponsors (e.g. a university trial sponsor with funding by NIA, a NIH trial, a VA funded trial, etc.), number of clinical sites monitored for the trial and frequency of monitoring visits, duration of monitoring work for each clinical trial. If the monitoring experience was tough a CRO (contract research organization) contracted by a university or NIH to manage the trial, please so indicate. Provide at least tee (3) references for listed experience of delivering GCP monitoring or auditing services for federally funded research. Experience in medical record and clinical chart review. Resume or CV must demonstrate experience, specifying the type of medical record systems (paper, electronic). For electronic health records specify commercial system experienced with and the tools used to access the electronic health record. Indicate experience with VA electron health record and tools used to access it. h) Computer knowledge Skilled in Microsoft Office Programs (e.g., Outlook Email, Word, PowerPoint, Excel and SharePoint), and Adobe Acrobat. Resume or CV must demonstrate experience by describing examples such as giving presentations with PowerPoint slides, documents written with Word, schedule planning with Excel, or combine files in Adobe Acrobat. Quality Assurance: The contractor shall detail their internal processes for working with a customer with regards to: Selection, assignment and evaluation of qualified personnel. Communication with a customer regarding scheduling, report transmittals, general interface with the customer, etc. 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. The following provisions apply to this acquisition: 52.212-1, Instructions to Offerors Commercial, (ix) 52.212-3, Offeror Representations and Certifications Commercial Items, with its offer. 52.212-4, Contract Terms and Conditions Commercial Items, 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders Commercial Items, 852.246-70, Guarantee Appendix C VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE File too large. May be found tough online search, if a copy is required, contact Contracting Officer at Michael.haydo@va.gov SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. A5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. 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; 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. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 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. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS I. GENERAL INSTRUCTIONS: To assure timely and equitable evaluation of proposals, offerors shall follow the instructions contained herein. Proposal packages shall be complete, self-sufficient, and respond directly to the requirements of this solicitation. The response shall consist of tee (3) separate volumes: Volume I Technical Proposal; Volume II Past Performance; and Volume III Price. A. The Contracting Officer has determined there is a high probability of adequate price competition in this acquisition. Upon examination of the initial offerors, the Contracting Officer will review this determination and if, in the Contracting Officer s opinion, adequate price competition exists, no additional cost information will be requested and certification under FAR 15.406-2 will not be required. However, if at any time during this competition the Contracting Officer determines that adequate price competition no longer exists; offerors may be required to submit information to the extent necessary for the Contracting Officer to determine the reasonableness of the price. D. The Minimum Proposal Acceptance Period is 60 days. The offeror shall make a clear statement in their proposal that their prices are valid for a period of not less than 60 days from the solicitation close date. F. Content Requirements. All information shall be confined to the appropriate Volume. The offeror shall confine submissions to essential matters, sufficient to define the proposal and provide adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each proposal. G. Proposal packages should be made up of separate technical and price proposals. Proposals shall be in electronic format only utilizing Microsoft Office and/or Adobe software. II. SPECIFIC INSTRUCTIONS: PROPOSALS SHALL BE SUBMITTED IN THREE (3) VOLUMES (Technical, Past Performance and Price): A) VOLUME I - TECHNICAL PROPOSAL: 1) OFFEROR SHALL SUBMIT TWO COPIES OF THE TECHNICAL PROPOSAL: COPY ONE: A FULL, NON-REDACTED COPY OF THE TECHNICAL PROPOSAL - OFFEROR MAY INCLUDE COMPANY NAMES, LOGOS, PHOTOS, EMPLOYEE NAMES, ETC. B) COPY TWO: A REDACTED COPY OF THE TECHNICAL PROPOSAL-OFFEROR SHALL ONLY USE OFFEROR CODE (SEE ABOVE) IN THIS COPY. DOCUMENT SHALL BE OF A PLAIN TEXT FORM AND ALL MENTION OF COMPANY NAMES, LOGOS, PHOTOS, EMPLOYEE NAMES, ETC SHALL BE REMOVED AND/OR REPLACED WITH THE OFFEROR CODE (SEE NOTES ABOVE). SUB-FACTOR 1. Understanding and Compliance with requirements The offeror shall address each task and solicitation requirement in sufficient detail to demonstrate a clear understanding of the statement of work and specific tasks, including the contractor qualifications, and certifications. The offeror shall provide a Project Management Plan to address the tasks necessary to complete the whole genome sequencing and shall include technical solutions to indicated requirements and how tasks will be met on schedule. Simply acknowledging the VA s requirements of the statement of work does not qualify for sufficiently demonstrating an understanding of the tasks. SUB-FACTOR 2. Relevant Experience: Experience reflects whether contractors have performed similar work before and is independent from the past performance factor below. 1. The offeror shall provide within its proposal the Relevant Experience which includes past, similar experience with performing Genome and Exome Genotyping on the proposed platform. This relevant experience shall also include the experience of Key Personnel and shall provide resumes. Project staff shall have the skills and experience in providing bioinformatics support for building VA specific content for the Exome Chip as well as experience in performing data analysis. 2. The offeror shall provide data on the level of experience in specific contracts of this type. Provide information on performance in these contracts, particularly as it relates to the offeror s Overall abilities. Information shall include Contract numbers, contracting activity points of contact, contract type, total awarded price, and a brief explanation of the scope of work. The Government reserves the right to obtain information for use in the evaluation of past performance from all sources. SUB-FACTOR 3. Delivery/Turnaround time The offeror shall address the turnaround time from the time the samples are received to the time the VA receives the required data. The offeror shall indicate solutions to how tasks will be met on schedule. B) VOLUME II PAST PERFORMANCE: PAST PERFORMANCE IS AN ASSESSMENT OF HOW WELL A CONTRACTOR PERFORMED UNDER PREVIOUSLY AWARDED CONTRACTS AND IS RATED SEPARATELY FROM EXPERIENCE. 1. Past performance The Offeror shall request past performance surveys from at least tee (3) current or previous contractors for contracts similar in size, scope, and complexity to this solicitation. Relevant contracts shall be within the past 3 years. Information shall include contract numbers, contracting activity points of contact, contract type, total awarded price, and a brief explanation of the scope of work. Surveys shall be sent directly from the agency to the contracting officer at: michael.haydo@va.gov and titled with this solicitation number. The Government reserves the right to obtain information for use in the evaluation of past performance from all sources. 2. Past performance questionnaires shall be submitted to Michael.haydo@va.gov no later than the close date/time listed on the solicitation. 3. The offeror shall provide past performance information or affirmatively state that it possesses no relevant information directly related to a similar past performance. An offeror failing to provide the past performance information or to assert that it has no relevant directly related or similar past performance may be considered in-eligible for award. Offerors lacking relevant past performance history will receive a neutral rating for past performance. C) VOLUME III PRICE: 1) PRICE SHALL BE ON THE CONTRACT LINE ITEM PAGE IN THE REQUEST FOR PROPOSAL Set Aside Cascading set-aside procedures. Any award resulting from this solicitation will be made using a cascading set-aside order of precedence as follows: 1. In accordance with FAR Subpart 19.1405 and VAAR Subpart 819.7005, any award under this solicitation will be made on a competitive basis first to an eligible Service Disabled Veteran Owned small business [SDVOSB] concern provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 2. If there is inadequate competition for award to an SDVOSB concern, the SDVOSB set-aside shall be withdrawn and cascaded to the next contracting order of priority in accordance with VAAR 819.7004, which is Veteran Owned Small Businesses (VOSB) and conducted in accordance with the procedures set forth in VAAR 819.7006 provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 3. If there continues to be inadequate competition between SDVOSB and VOSB concerns, the cascading will continue tough the contracting order of priority in accordance with VAAR 819.7004 and FAR 19.203. If the contracting officer determines that offers from small business concerns do not meet the solicitation requirements in terms of technical acceptability, past performance, and fair market price, the small business set-aside[s] will be withdrawn and award will be made on the basis of full and open competition. Adequate competition: Adequate competition shall be deemed to exist if At least two competitive offers are received from qualified, responsible business concerns at the set-aside tier under consideration; and Award could be made at fair market price as determined in accordance with FAR 19.202-6. The VA contracting officer reserves the right to consider competitive proposals submitted from all responsible offerors (including large businesses) in determining the fair market price. Due date and submission of quotes: 1. QUESTIONS ABOUT THE REQUEST FOR PROPOSAL OR THE POSTING OF THE REQUEST FOR PROPOSAL MUST BE SUBMITTED BY 02/9/2021 AT 10:00 AM EST. QUESTIONS AND ANSWERS WILL BE ADDRESSED VIA RFQ AMENDMENTS AND POSTED WITH THE RFQ. QUESTIONS MUST BE SUBMITTED VIA EMAIL TO MICHAEL.HAYDO@VA.GOV. The quotes are due on 2/15/2021 at 10:00 AM (EST) and shall be directed electronically to michael.haydo@va.gov. Quotes shall be marked with the solicitation number. Information regarding the solicitation can be addressed to the Contracting Officer, Michael Haydo, michael.haydo@va.gov
36C24E21Q0042 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
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