Notice Type: Sources Sought Notice
Posted Date: 16-JAN-18
Office Address: Department of Veterans Affairs;Network Contracting Office 9;1639 Medical Center Parkway;Suite 400;Murfreesboro TN 37129
Subject: 65– Radiophamaceuticals
Classification Code: 65 – Medical, dental & veterinary equipment & supplies
Solicitation Number: 36C24918Q0184
Contact: Lori L Ellis615-225-6338 Lori.Ellis2@va.gov mailto:Lori.Ellis2@va.gov
Place of Performance (address): VA Tennessee Valley Healthcare System Medical Cent;Nashville Campus;l3l0 24th Avenue South;Nashville, TN
Place of Performance (zipcode): 37212-2637
Place of Performance Country: USA
Description: Department of Veterans Affairs
Department of Veterans Affairs Medical Center
The Department of Veterans Affairs Medical Center, NCO 9 Network Contracting Office, on behalf of the Nashville and Murfreesboro VA Medical Center is conducting market research through this sources sought notice to seek sources to identify potential experienced businesses that are capable of meeting the requirements per the Statement of Work (SOW) below. The North American Industry Classification System (NAICS) Code for this acquisition is 325412. Disclaimer and Important Notes: This Sources Sought Notice is for market research purposes only and does not constitute a Request for Proposal/Quotation, and it is not considered to be a commitment by the Government to award a contract nor will the Government pay for any information provided; no basis for claim against the Government shall arise as a result from a response to this Sources Sought Notice or Government use of any information provided. Failure to submit information in sufficient detail may result in considering a company as not a viable source and may influence competition and set-aside decisions. Regardless of the information obtained from this Sources Sought Notice, the Government reserves the right to consider any arrangement as deemed appropriated for this requirement. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response to this Sources Sought Notice. The Government reserves the right to use any information provided by respondents for any purpose deemed necessary and legally appropriate, including using technical information provided by respondents in any resultant solicitation. At this time, no solicitation exists; therefore, Do Not Request a Copy of the Solicitation. After a review of the responses received, a pre-solicitation notice and solicitation may be published on Federal Business Opportunities (FedBizOpps) website. It is the potential offeror’s responsibility to monitor FedBizOpps for release of any future solicitation that may result from this Sources Sought Notice. However, responses to this Sources Sought Notice will not be considered adequate responses to any resultant solicitation.Pursuant to FAR Part 10 (Market Research), the purpose of this notice is to: (1) determine if sources capable of satisfying the agency’s requirements exists, (2) determine if commercial items suitable to meet the agency’s needs are available or could be modified to meet the agency’s requirements, and (3) determine the commercial practices of company’s engaged in providing the needed service or supply. Pursuant to FAR Part 6 and FAR Part 19, competition and set-aside decisions may be based on the results of this market research. This notice in no way obligates the Government to any further action.
The Government is particularly interested in identifying Service Disabled Veteran Owned Small Business (SDVOSB)/Veteran Owned-Small Business (VOSB) and their capability. The Government is seeking potential sources to provide Radiopharmaceuticals for the VA Medical Center, Nashville and Murfreesboro, TN. This notice is to assist the VA in determining sources only. This is not a solicitation for proposals or quotes. A solicitation will be issued at a later date and time. All information submitted in response to this source sought notice is considered voluntary.
CCR: Interested parties should register in the SAM as prescribed in FAR Clause 52.232-33. The SAM can be obtained by accessing the internet at www.sam.gov.
STATEMENT OF WORK
RADIOPHARMACEUTICAL (ISOTOPES) SUPPLIES & SERVICES
I. STATEMENT OF OBJECTIVES
The Contractor will be required to provide radiopharmaceutical supplies and services to the VA Tennessee Valley Health Care System (TVHS) on a daily basis, Monday through Friday, and on weekends and national holidays as needed for emergency procedures. Services will include, but are not limited to the following:
A. DELIVERY: Authorized employees of TVHS will place orders on an as needed basis. Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of TVHS. Two free daily deliveries during routine business hours defined as Monday-Friday 0800-04:00 pm (excluding holidays). Contractor will supply two (2) phone numbers for ordering after working hours. Orders shall be placed the afternoon before the required delivery date for exact quantities of each unit dose or quantity for bulk (vial) orders. In addition to the two free daily deliveries, emergency orders can be placed at any time with expected delivery within one (1) hour of the order. Deliveries during normal business hours will be to: Nuclear Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129. Delivery personnel will be bonded by the contractor.
The contractor will provide, prepare and QC Myoview or Sestamibi kits for Myocardial Perfusion Imaging. Technetium will be provided by the contractor.
As needed, the contractor will provide unit dose radiopharmaceuticals on weekends and holidays for emergency procedures. Radioactive shipments prepared in advance to anticipate emergency or routine studies are not acceptable. Deliveries outside of normal business hours will be to: Nuclear Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129.
QUALITY: Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control
(QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided twenty-four hours per day, seven days per week, upon request and at no charge.
WASTE REMOVAL: Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials) without cost. Safe transport of the waste is the responsibility of the contractor. The Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and Nuclear Regulatory Commission (NRC) requirements regarding radioactive materials.
INVOICES: The Nuclear Medicine Department shall be provided with copies of the invoices.
Invoices shall be paid to the contractor monthly, in arrears, upon submission of a properly prepared invoice for services/ supplies during the period. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges. Invoices shall be sent to Austin, Texas for on-line certification.
COMPUTER SYSTEM: The Contractor shall provide computer hardware and software for the management and disposal of inventory, patient dose records. The Contractor will provide updates on computer systems as needed.
HARDWARE: The Contractor will provide equipment as needed and deliver the equipment to
The Nuclear Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129. The VA Tennessee Valley Healthcare System VAMC will prepare the area to which the equipment is to be delivered. Training on the equipment shall include a minimum of two (2) personnel. The VA Tennessee Valley Healthcare System VAMC will use the equipment in a careful and proper manner and shall comply with the laws, ordinances, and regulations relating to the possession, use, or maintenance of the equipment. The equipment is intended to be used with the software package described in this section. The equipment shall be kept at the VA Tennessee valley Healthcare System VAMC and will not be removed without contractor s prior written consent. Upon receipt, the equipment will be inspected by the VA Tennessee valley Healthcare System VAMC s Engineering Service prior to use to assure it is in good working condition. The VA Tennessee valley Healthcare System VAMC shall not make any alterations, additions, or improvements to the equipment without prior written consent of Contractor. All additions or improvements of any kind made to the equipment shall belong to and become the property of the Contractor upon the expiration or earlier termination of the lease.
The contractor shall keep the equipment in good working order, and shall furnish all parts, mechanisms, and devices to keep the equipment in good mechanical working order. Should the equipment fail to operate at no fault to the VAMC, the contractor will repair and/or replace by close of business the next business day. In the event VA Tennessee Valley Healthcare System act or negligence causes damage to the equipment, the costs of repairing such damage will be the responsibility of the VA Tennessee Valley Healthcare System. The VA Tennessee Valley Healthcare System assumes the risk of loss, theft, or destruction of, and damage to the equipment. Should one or more units of the equipment be totally and permanently lost, stolen, or damaged beyond repair as to preclude continued use for the purpose intended, VA Tennessee valley Healthcare System shall replace the same.
SOFTWARE: The contractor grants the VA Tennessee Valley Healthcare System a nonexclusive, nontransferable license to possess and use the software package in machine-readable form only on a single personal computer located at the VA Tennessee Valley Healthcare System Nuclear Medicine Department. VA Tennessee Valley Healthcare System may not copy or transfer the software or license to another party. Use means loading onto or transmitting to the single personal computer and executing storing or displaying thereon. The contractor shall deliver to the VA Tennessee Valley Healthcare System the licensed programs in machine readable object code form and support materials sufficient for VA Tennessee valley Healthcare System exercise of its rights under this license. This software license shall remain in full force and effect at no charge for the term of this contract provided the VA Tennessee valley Healthcare System complies with the terms and conditions of this contract.
Upon termination, for any reason, VA Tennessee Valley Healthcare System shall promptly return the software together with all its copies, modifications, and merged portions in any form to the contractor. The VA Tennessee Valley Healthcare System may not copy, reproduce, sublicense, assign or transfer this license or the software or remove any copyright or other proprietary notices form the licensed software. Any attempt to sublicense, assign, or transfer any of the rights, duties or obligations hereunder is expressly prohibited. The licensed software and all its intellectual property rights, including without limitation, patent, trademark, copyright and trade secret rights in the licensed software are and shall be the property solely of the contractor. The contractor does not warrant that the functions contained in the software will meet VA Tennessee valley Healthcare System requirements or that the operation of the software will be uninterrupted or error free. The contractor warrants the disk on which the software is furnished, to be free from defects in materials and workmanship under normal use for the period of ninety days from date of delivery to the VA Tennessee valley Healthcare System as evidenced by a copy of the receipt. The contractor makes no other warranties with regard to the software. The contractor expressly and specifically disclaims any warranty of merchantability or fitness for a particular purpose. The contractor entire liability and VA Tennessee valley Healthcare Systems exclusive remedy shall be: (a) the replacement of any disk not meeting the contractor s limited warranty and which is returned to the contractor within 90 days of the date of delivery; or (b) if the contractor is unable to deliver a replacement disk which is free of defects in materials or workmanship. The VA Tennessee valley Healthcare System may terminate this agreement by returning the software to the contractor. In no event, will the contractor be liable to the VA Tennessee Valley Healthcare System for any damages including and lost profits, lost savings, or other incidental or consequential damages arising out of the use, or inability to use such software or for any claim by any other party.
II. TERM OF CONTRACT
This contract is effective for the period October 1, 2018 thru September 30, 2019, with four (4) one year (1) options to renew. The option to extend for additional periods (if required) will be at the discretion of the Government. This contract is subject to the availability of VA funds.
Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the definitions and other sections of this contract, the language in this section shall govern.
A. Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.
B. Contracting Officer s Representative (COR) – A person appointed by the CO to take necessary action to ensure the contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.
C. Veterans Health Administration (VHA) – The central office for administration of the VA medical centers throughout the United States. The VHA is located in Washington, DC.
D. Veterans Integrated Services Network (VISN) – The regional oversight for the VA Medical Centers in Memphis, TN, Tennessee Valley Healthcare System (Murfreesboro and Nashville), Louisville, KY, Lexington, KY and Mt. Home, TN. The VISN office is located at 1801 West End Avenue, Suite 1100, Nashville, TN 37203.
IV. QUALITY REQUIREMENTS
Contractor shall guarantee the quality of the radiopharmaceutical. Quality Control (QC) shall include pH testing, percent tag, alumina and 99Mo breakthrough as appropriate. Quality Control shall be performed on each agent dispensed. Complete documentation of QC results will be provided upon request. All radiopharmaceuticals shall be calibrated and labeled with concentration, time, total volume, and total activity. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided upon request at no charge.
On an annual basis, the Contractor will provide documentation demonstrating compliance with NRC requirements to the Radiation Safety Officer.
V. CREDENTIAL REVIEWS/PRIVILEGING
VI. KEY PERSONNEL
A. The Contractor will designate one person who can be contacted for any problems or issues that arise in the performance of this contract to the VA Tennessee Valley Healthcare System with a phone number. The VA Tennessee Valley Healthcare System will also designate a contact person.
B. The contractor must identify key personnel proposed to provide the required services and their qualifications upon award of contract and on an annual basis thereafter. The contractor cannot change key personnel without VAMC approval.
VII. PATIENT RIGHTS AND SAFETY
A. The VA Tennessee Valley Healthcare System is not responsible or liable for any unsafe condition caused by the Contractor or Veteran.
B. The Contractor will have evidence of implementation of the Joint Commission National Patient Safety Goals as applicable.
VIII. CONTINUUM OF CARE
Individual radiopharmaceuticals will be provided in unit dose form and will be delivered at the request of the VA Tennessee Valley Healthcare System
IX. QUALITY ASSURANCE SURVEILLANCE PLAN
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. The performance standards are as follows:
Acceptable Quality Level
Method of Surveillance
Patient Safety and Quality Control
Pharmaceutical dose accuracy
Contractor will guarantee that all radiopharmaceutical doses are delivered according to specific request.
All doses are verified by Nuclear Technicians. Contractor will be immediately notified of discrepancies. Nuclear Techs will document all incorrect doses on log and report to Cardiology Manager.
Replacement dose will be provided within one hour of call, and there will be no charge for dose or delivery.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
Availability and responsiveness of radiopharmaceutical consultation services
Consultation services will be immediately available by telephone, 24hrs/day, 7 days per week.
Nuclear Techs will document instances of failure.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
Evidence of compliance with NRC Requirements
On an annual basis, the Contractor will provide a copy of current NRC license. License will be received at VAMC before previous license expires.
Radiation Safety Officer will monitor and report receipt of license to COR.
Noncompliance may result in unfavorable contractor performance evaluation, which could result in not exercising option period.
X. ENVIRONMENT OF CARE
Each workday, the contractor shall remove all radioactive waste generated by contractor (to include all syringes and vials). Safe transport of the waste is the responsibility of the contractor. Contractor must adhere to OSHA guidelines regarding blood borne pathogens, DOT regulations, Board of Pharmacy regulations pertinent to radiopharmaceuticals, and NRC requirements regarding radioactive materials
XI. INFORMATION MANAGEMENT SECURITY
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA personnel regarding information system security.
2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
A. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
B. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
C. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.
D. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.
E. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.
3. VA INFORMATION CUSTODIAL LANGUAGE
A. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor’s rights to use data as described in Rights in Data – General, FAR 52.227-14(d) (1).
B. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.
C. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
D. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
E. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
F. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
G. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
H. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.
I. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.
J. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
K. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.
L. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.
4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT
A. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.
B. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.
C. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall.
D. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.
E. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.
F. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.
G. The contractor/subcontractor agrees to:
1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:
a) The Systems of Records (SOR); and
b) The design, development, or operation work that the contractor/subcontractor is to perform;
2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and
3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.
H. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.
1) Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.
2) Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.
3) System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.
I. The contractor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hot-fixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the contractor anywhere in the Systems, including Operating Systems and firmware. The contractor shall ensure that Security Fixes shall not negatively impact the Systems.
J. The contractor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 working days.
K. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the contractor shall provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the contractor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within three working days.
L. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
A. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation.
B. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.
C. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.
D. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor /subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.
E. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.
F. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.
G. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.
H. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the contractor at the end of lease, for trade-in, or other purposes. The options are:
1) Contractor must accept the system without the drive;
2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
a) The equipment contractor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.
c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
A. 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 COR 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.
B. 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.
C. 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.
D. 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.
7. LIQUIDATED DAMAGES FOR DATA BREACH
A. Consistent with the requirements of 38 U.S.C. –5725, 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.
B. 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.
C. Each risk analysis shall address all relevant information concerning the data breach, including the following:
1) Nature of the event (loss, theft, unauthorized access);
2) Description of the event, including:
a) Date of occurrence;
b) Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
3) Number of individuals affected or potentially affected;
4) Names of individuals or groups affected or potentially affected;
5) 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;
6) Amount of time the data has been out of VA control;
7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
8) Known misuses of data containing sensitive personal information, if any;
9) Assessment of the potential harm to the affected individuals;
10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
11) 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 $5,000 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
2) One year of credit monitoring services consisting of automatic daily monitoring of at least three relevant credit bureau reports;
3) Data breach analysis;
4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
6) 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.
XII. HIPPA AND OTHER REGULATORY COMPLIANCE
1. Contractor shall adhere to provisions of Public Law 104-191, Health Insurance Portability and
Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).
2. Contractor shall provide health care to patients seeking such are from or though VA. As such, the Contractor is considered Part of the Department health activity for purposes of the following statutes and the VA regulations implementing these statutes: The Privacy Act, 5 U.S.C. 552A AND 38 U.S.C. sections 5701, 7705, and 7332. Contractor and its employees may have access to the VA patient medical records to the extent necessary for the contractor to perform the contract, notwithstanding patient treatment records only pursuant to explicit disclosure authority from VA. Contractor and its employees are subject to the penalties and liabilities provided in the statutes and regulations mentioned in the paragraph for unauthorized disclosures of such records and their contents. Records created by the contractor in the course of treating VA patients under this agreement, are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable Federal Law and Regulations. Upon the expiration of this contract or termination of the contract, the contract shall promptly provide the VA with the individually identified VA patient treatment records. VA has unrestricted access to the records generated by the contractor pursuant to this contract.
XIII. ON CALL REQUIREMENTS AND HOW THEY WILL BE BILLED
Emergency orders can be placed at any time with delivery within one (1) hour of the order. Deliveries during normal business hours will be to: Nuclear Medicine, Room A-25, VA Tennessee Valley Healthcare System, 1310 24th Avenue South, Nashville, TN 37212, and 3400 Lebanon Pike, Murfreesboro, TN 37129.
Technetium LEU-99m MDP patient dose, 15-30mCi
Technetium LEU 99m-DTPA, patient dose 30-45mCi
Technetium LEU-99m Pertechnetate patient dose, 12 to 40 mCi
Technetium LEU-99m MAA patient dose, 4 to 5 mCi
Technetium LEU-99mTc Sulfur Colloid patient dose, 5-12 mCi
Technetium LEU- 99m Mebrofenin patient dose, 4 to 6 mCi
Technetium LEU 99m Pertechnetate 200mCi, dose cal linearity
Technetium LEU -99m MAG3 patient dose, 5 to 10 mCi
WBC Label (indium 111 OXINE)
WBC label (LEU ) 99mTc – HMPAO
Technetium LEU -99m Tetrofosmin unit-dose
Technetium LEU-99m, pertechnetate, patient dose, 1 to 11 mCi
Technetium LEU 99m Sulfur Colloid, 200 to 1000 uCi
Technetium LEU 99mTc- Sestamibi, patient dose, 8 to 30 mCi
Thallium-201 per mCi
Gallium-67 patient dose, per mCi
I-131 radioactive Uptake Capsule, patient dose 15 to 30 uCi
I-131 Capsule patient dose 1-6mCi
I-131 Therapy capsule, per mCi, ea addn mCi above 6 mCi,
111-Indium DTPA 1.5mCi vial
I-123 Whole Body Scan 4 mCi
I-123 capsule, 100uCi
I-123 Dx capsule 200 uCi
I-123 MIBG per dose 10 mCi
Biodose dose management system, (York) Annual maintenance
Biodose dose management system, (Nashville) Annual maintenance
Leuckocyte prep kit
Emergency Call Out (after hours)
Submission of Information: Companies having capabilities necessary to meet or exceed the stated requirements are invited to provide information to contribute to this market survey/sources sought notice including commercial market information and company information. Companies may respond to this Sources Sought Notice via e-mail to Lori.Ellis2@va.gov no later than January 30, 2018 at 10:00 AM, Central Time with the following information/documentation:
1. Name of Company, Address and DUNS Number.
2. Point of contact and Phone Number.
3. Business Size applicable to the NAICS Code: a. HuBZone Small Business; b. Service-Disabled Veteran Owned Small Business (SDVOSB); c. Veteran Owned Small Business (VOSB); d Small Business; e. Large Business
4. Documentation Verifying Small Business Certification:
a. If claiming HuBZone status, provide a copy of your HuBZone Certificate from SBA.
b. If claiming SDVOSB/VOSB status, provide documentation that shows the business is VetBiz certified.
d. If claiming Small Business status, provide documentation to show the business is small under NAICS code 325412.