Loren Data's SAM Daily™

FBO DAILY ISSUE OF FEBRUARY 19, 2011 FBO #3374
DOCUMENT

J -- provide preventive maintenance and repair of the Radiation Therapy Equipment - Attachment

Notice Date

2/17/2011
 

Notice Type

Attachment
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;James A. Haley Veterans Hospital (90C);13000 Bruce B. Downs Blvd;Tampa FL 33612
 

ZIP Code

33612
 

Solicitation Number

VA24811RI0189
 

Response Due

2/25/2011
 

Archive Date

3/7/2011
 

Point of Contact

Adalberto Afanador
 

E-Mail Address

CT
 

Small Business Set-Aside

N/A
 

Description

Description This is a SOURCES SOUGHT ANNOUNCEMENT ONLY FOR MARKET RESEARCH PURPOSE ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought are preferred VIA E-MAIL but you can mail or use a ground carrier. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses and Small Businesses interested and capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to perform this requirement. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of business, e.g. Services Disabled Veteran Owned Small Business or Veteran-Owned Small Business; (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below and; (j) evidence of experience doing the same type of work (k) estimated prices. Furnish all labor, transportation and parts necessary to provide preventive maintenance and repair of the Radiation Therapy Equipment listed below for the approximate period of 1 May 2011 to April 30 2012 and 4 additional option years thereafter. Each respondent must have a verifiable established business with an office and full time staff to include a "fully qualified" field service engineer (FSE) and a "fully qualified" FSE who will serve as backup. Fully qualified is based upon training and expertise in the field. For training, the FSE(s) has successfully completed a formalized training program of the equipment identified below. For field experience the FSE(s) shall have a minimum of two years experience with respect to schedules and unscheduled remedial maintenance for linear accelerator equipment. The FSE(s) shall be authorized by the contractor to perform the maintenance services. The contractor shall provide written assurance to the competency of their personnel and a list of their credentials on approved FSE(s) for each model the contractor services at the Tampa VA. The Contracting Officer (CO) may authenticate training requirements, request training certificates, or credentials from the contractor at any time for any personnel who are servicing or installing VA equipment. The CO or Contracting Officer Technical Representative (COTR) specifically reserves the right to reject any of the contractor's personnel and refuse them permission to work on the listed VA equipment. If any subcontractors are used, they must be approved in advance by the CO; the contractor shall submit any proposed change in subcontractor (s) to the CO for approval or disapproval. Inspection of the equipment and any site visits by the contractor will be coordinated in advance with COTR, Biomedical Engineering. Consumable parts and supplies will not be covered under the proposed contract. EQUIPMENT: 1.VARIAN CLINAC 21/23 EX SERIES LINEAR ACCELERATOR S/N H290369, ID#47399, INCLUDING ALL HARDWARE AND SOFTWARE INCLUDING MULTI-LEAF COLLIMATOR, PORTALVISION. LOCATED IN ROOM 034B-32. 2.VARIAN CLINAC 21/23 EX SERIES LINEAR ACCELERATOR S/N H290516, ID#55151, INCLUDING ALL HARDWARE AND SOFTWARE INCLUDING MULTI-LEAF COLLIMATOR, PORTALVISION. AND RPM RESPIRATORY GATING LOCATED IN ROOM 035-32. 3.VARIAN CLINAC 21/23 EX SERIES LINEAR ACCELERATOR S/N H29235, ID#80870, INCLUDING ALL HARDWARE AND SOFTWARE INCLUDING MULTI-LEAF COLLIMATOR, PORTALVISION. AND ON BOARD IMAGING LOCATED IN ROOM 034A-32. The contractor shall also comply with the policies of the VA. Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 339113 "Surgical Appliance and Supplies Manufacturing" (500). Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the Central Contractor Registration (CCR located on the web at www.ccr.gov). It is desirable that any Offeror completes their business Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail, mail or ground carrier to: Adalberto Afanador James A. Haley Veterans Hospital (JAHVH) Network Contracting Activity 8 8875 Hidden River Parkway Tampa, FL 33637-1035 by e-mail to Adalberto.Afanador@va.gov. All information submissions to be marked Attn: Adalberto Afanador, Contract Specialist (PBD) and should be received no later than 4:30 PM Eastern Time on Feb 25, 2011. This is just for MARKET RESEARCH purposes. STATEMENT OF WORK LINEAR ACCELERATOR MAINTENANCE CONTRACT SCOPE: The contractor shall furnish all labor, transportation, tools, and parts necessary to provide preventive maintenance and repair of the radiation therapy equipment (linear accelerators) listed below for the period 10-1-10 through 9-30-11, both dates inclusive. TYPE OF CONTRACT: The contract will be firm-fixed-price. QUALIFICATIONS: Each respondent must have an established business, with an office and full time staff to include a "fully qualified" field service engineer (FSE) and a "fully qualified" FSE who will serve as backup. "Fully qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program of the equipment identified below. For field experience, the FSE(s) has a minimum of two years experience with respect to scheduled and unscheduled preventive and remedial maintenance of linear accelerators/radiation therapy equipment. The FSE(s) shall be authorized by the contractor to perform the maintenance services. All work shall be performed by "fully qualified" competent FSE(s). The contractor shall provide written assurance to the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the VA. The Contracting Officer (CO) may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VA equipment. The CO and/or Contracting Officer's Technical Representative (COTR) specifically reserves the right to reject any of the contractor's personnel and refuse them permission to work on the VA equipment. If subcontractors are used, they must be approved in advance by the CO; the contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. SERVICES TO BE PROVIDED: A. Repair - 1. All repairs will be performed during normal VA business hours, 8:00 AM - 5:00 PM, Monday-Friday, except Federal Holidays, unless otherwise specified. Contractor may work outside normal business hours by arrangement with COTR if such services are provided without additional charge to the government. Any overtime charges must be approved by the COTR or designee prior to the initiation of overtime work. 2. A technical maintenance representative will respond by telephone to the VA within one (1) hour of the original service call. Technical telephone support will be available from 7:00 AM to 7:00 PM. The contractor will arrive on-site for repair within two (2) hours of the original service call. Equipment will be returned to full operation within twenty-four (24) business hours of the original call. On-site visits will be authorized by COTR only. 3. The VA shall not provide service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE(s) all operational and technical documentation (e.g., operational and service manuals, schematics, and parts lists) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request. Any charges for parts, manuals, tools, or software required to successfully complete scheduled Preventive Maintenance (PM) are included within this contract and its agreed upon price unless specifically stated in writing otherwise. B. Parts - All replacement parts, except exclusions listed below, required to keep equipment performing within the manufacturer's specifications will be provided by the contractor. All parts must meet or exceed factory specifications to maintain compatibility with systems presently in place and with future performance/reliability upgrades. Parts removed (replaced) by the contractor become the property of the contractor. C. Scheduled Maintenance - 1. The contract will include four (4) comprehensive scheduled maintenance inspections (preventive maintenance) to be performed in December, March, June, and September. A mutually agreeable time for the inspections will be scheduled through the COTR. All preventive maintenance inspections shall be scheduled after hours (beginning at 5:00 PM). 2. The contractor will perform PM service to ensure that equipment listed below functions in conformance with the latest published editions of NFPA-99, OSHA, CDRH, CAP. The contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable) provided to the COTR at the completion of the PM. Preventive maintenance procedures will be submitted to COTR for approval prior to initiation of this service contract. PM services shall include but need not be limited to the following: Cleaning of equipment; Reviewing operating system diagnostics to ensure that the system is operating to the manufacturer's specifications; Calibrating and lubricating the equipment; Performing remedial maintenance of non-emergent nature; Testing and replacing faulty or worn parts and/or parts which are likely to become faulty, fail, or become worn; Inspecting all cables and bushings and replacement as necessary; Measuring, adjusting, aligning, and calibrating as necessary for optimal performance; Inspecting and replacing where indicated electrical wiring and cables for wear and fraying; Inspecting and replacing where indicated all mechanical components including but not limited to devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance; Returning the equipment to full and proper operating condition; Providing documentation of service performed. Parts and assemblies will be repaired or replaced as necessary. An electrical safety inspection will be done at the time of the preventive maintenance and results will be documented. SPECIAL INSTRUCTIONS: A. Contractor Check-in - The contractor's representative will report to Biomedical Engineering, D022-01, prior to performance of service. On approved overtime, contractor will report to Hospital Police, E.R. Lobby. B. Documentation - at the conclusion of each repair or scheduled maintenance visit, the contractor will provide a written service report indicating the date of service, the Bar Code Number (EE#), the model, serial number, and location of the equipment serviced, the name of the service representative, the hours worked, and the services performed and parts replaced. The reports will be delivered to Biomedical Engineering for signature when work is complete. During non-standard hours, report will be taken to Hospital Police for signature. TERMS AND CONDITIONS: A. Exclusions - Consumable parts and supplies are not covered under this contract. B. Inspection of Equipment - Any site visits will be coordinated in advance with COTR, Biomedical Engineering, (813) 972-7632. EQUIPMENT COVERED: A. Varian Clinac 21/23 EX Series linear accelerator, S/N H290369, ID# 47399, including all hardware and software including multi-leaf collimator and portalvision, located in 034B-32 B. Varian Clinac 21/23 EX Series linear accelerator, S/N H290516, ID# 55151, including all hardware and software including multi-leaf collimator, portalvision, and RPM respiratory gating located in 035-32 C. Varian Clinac IX Series linear accelerator, S/N H294235, ID# 80870, including all hardware and software including multi-leaf collimator, portalvision, and on-board imaging located in 034A-32 VA SECURITY INFORMATION The C&A requirements do not apply, and that a Security Accreditation Package is not required. 1. SUBPART 839.2 - INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and 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 on site 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 COTR. 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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COTR 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 vendor 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, hotfixes, 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 vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. 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 vulnerablity 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 COTR 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 COTR. 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 vendor at the end of lease, for trade-in, or other purposes. The options are: (1) Vendor 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 vendor 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 pre-approved 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 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. 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 othercompensation 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1)Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 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-day's 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. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: VA HANDBOOK 6500.6 (1)Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior. (2) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/TaVAMC673/TaVAMC673/VA24811RI0189/listing.html)
 

Document(s)

Attachment
 

File Name: VA-248-11-RI-0189 VA-248-11-RI-0189.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=177287&FileName=VA-248-11-RI-0189-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=177287&FileName=VA-248-11-RI-0189-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02382177-W 20110219/110217234200-450d22f4d13c0b4e1800344febbbe43e (fbodaily.com)
 

Source

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