Statement of Work.docx

STATEMENT OF WORK

Medical Record Scanning and Record Management Services

1. Scope of Work: The contractor shall supply all required labor, materials, tools, equipment, supplies, transportation and certifications necessary to maintain medical record Scanning and Record Management/File Room Storage services for the Veterans Affairs Palo Alto Health Care System (VAPAHCS) which includes: Palo Alto Division, Menlo Park Division, Livermore Division, and five Community Based Outpatient Clinics. Services provided by the contractor shall be on-site defined as VAPAHCS owned or leased property or off-site defined as contractor owned property.

1.1 Pick up/Delivery Locations:

· Palo Alto Division 3801 Miranda Ave Palo Alto, CA 94304

· Menlo Park Division 795 Willow Road Menlo Park, CA 94025

· Livermore Division 4951 Arroyo Road Livermore, CA 94550

· San Jose Outpatient Clinic 5855 Silver Creek Valley Place San Jose, CA 95138

1.2 The Medical Record File Room Service: This service shall consist of two objectives: maintenance and storage of records. File room maintenance is to include paper medical records that will be picked up from VAPAHCS and brought to contractor site to be scanned, indexed, and images delivered onto VA Health System Wide Area Network (WAN) for electronic access by VAPHCS employees. See detailed requirement in paragraph 7.

1.2.1 Medical record file room storage will consist of:

· The original paper medical records;

· Nuclear Medicine Film Library;

· Pathology slides and tissue blocks.

1.3. Record Management Storage: Contractor shall provide a National Archives and Records Administration (NARA) certified record storage facility, with the capacity to accommodate 28,000 linear feet box storage of federal records; both medical and non-medical in nature. The contractor shall provide personnel who understand VA Records Control Schedule (RCS) 10-1 and the General Records Schedule (GRS) and name a NARA Certified Records Manager as a single point of contact for intake/processing of new material and client education. See detailed requirement in paragraph 8.

2. Objective: Contractor shall provide a NARA certified record storage facility, and maintain VAPAHCS government records in compliance with the NARA approved records control schedule 10-1 in all multi-media formats. Contractor shall maintain an active off-site medical record file room; to include remote scanning into VistA Imaging and chronological prong filing of paper records in an individual identifiable chart for each VAPAHCS Veteran.

3. Demographics and Workload Statistics:

Contractor shall provide off-site NARA approved storage and management of government records, including sensitive patient identifiable medical records. Contractor shall provide a secure inventory and retrieval system of record storage databases for timely recall of records; inventory to include box storage by accession number.

4. Normal Hours of Operation:

Contractor shall provide 8:00 am to 4:30:00 pm, Monday thru Friday hours of operation.

5. Outside Normal Hours of Operation:

Contractor shall provide services during on-call non-business hours 24 hours a day and 7 days a week, including holiday coverage for emergency operation. Overtime work is not authorized and will be at contractor’s expense if deemed necessary.

5.1 Federal Holidays:

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows where no services will be conducted and/or charges incurred:

Under current definitions, five are set by date:

New Year's Day, January 1 Independence Day, July 4 Veterans Day, November 11 Christmas Day, December 25 Juneteenth, June 19

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday. The other six are set by a day of the week and month:

Martin Luther King's Birthday, Third Monday in January Washington's Birthday, Third Monday in February Memorial Day, Last Monday in May Labor Day, First Monday in September Columbus Day, Second Monday in October Thanksgiving, Fourth Thursday in November

6. General Requirements for all VA records:

6.1. Disaster Recovery: Upon Contracting Officers Representative (COR) request, the contractor shall provide seamless service with extensive disaster recovery and backup plans and procedures.

6.2. Security: The contractor’s commitment to security must compliance with 36 CFR 1234 (formerly numbered 36 CFR 1228, subpart K) certified by NARA.

6.2.1. The Contractor shall make certain that appropriate physical care and security measures are taken to ensure that documents and health records and the VA information they contain are not damaged or compromised throughout the entire process from the point of receipt through the return shipment. A high-level of security should be applied as documents are transported in enclosed, locked vehicles by the contractor’s permanent staff. All vehicles are required to be secure at all time whether parked or in transit by having all windows closed and all doors locked. All records are transported in person.

6.2.2. All records in the contractor’s possession must be secure, from the moment they leave VA’s site to document preparation and imaging to the transfer of indexed electronic images and data. Work must be performed in a secured area protected by key access reader technology and security monitoring cameras.

6.2.3. The contractor’s security and technology processes should be based upon a security policy that meets VA standards and is checked from time to time. This policy should cover security roles and responsibilities, physical security, password policies, incident reporting, change control, data privacy, encryption, external connection guidelines, and similar topics. Data management and access procedures are to be compliant with industry standards. Encryption technologies should be used to transmit sensitive patient data to meet or exceed HIPAA standards. A chief security coordinator must oversee the security and audit team

7. Medical Record File Room Requirements:

7.1. The Contractor shall be responsible for:

7.1.1. Transportation of records:

· The contractor shall pick up records from the VA Palo Alto Health Care System at the following locations:

1. Palo Alto Division Health Information Management Section- Twice/daily between 7am-5pm.

2. Palo Alto Division Lab- Requested as needed- TAT 24-48 hours.

3. San Jose Clinic- Once/daily between 7am-5pm.

4. Menlo Park Division- Twice/weekly- Tuesday and Thursday between 7am- 5pm.

5. Livermore Division - Once/daily between 7am-5pm.

7.1.2. Scanning and indexing of documents:

· Remote Scanning Services: Contractor has the capacity to scan on average around 1 million images per year, while maintaining a high quality image that is center oriented, well defined, clear, and easily read. Images shall be captured in VA VistA Imaging application within 24 hours of reception at vendor’s site. 100% of documents scanned under this Service Proposal are to be viewed for quality and orientation. If the contractor cannot meet the specified deadline they must notify the COR as soon as possible, but not to exceed 3 business days.

· Contractor shall have:

1. Capabilities to scan to the configuration of VistA Imaging.

1. Contractor shall be required to scan documents with a minimum resolution of 300 x 300 dots per inch (dpi) as established by VistA Imaging specifications and ensure that images are correctly indexed, oriented, legible, and complete, including signature by the originating provider (VistA Imaging Clinical Capture User Manual). Scanned documents may be scanned in black/white, gray scale, true color, or 256 color (depending on the document is).

1. Scan on Demand Service: The requested document by VA to be pulled from the inventory, scanned, indexed and archived.

· In order to preserve the “continuity of patient care”, contractor shall remotely scan VA and non-VA medical records received, only into the Veterans Affairs - Computerized Patient Record System (CPRS) - Vista Imaging.

· Contractor shall provide quality assessment (QA) of their scanning/indexing services and quality benchmarking shall be 100% accuracy. Contractor shall ensure correct patient, correct type of document, signatures, pages sequenced in order, proper orientation, and clarity as a minimum. Scanned paper documents with 100% QA accuracy shall be set aside for destruction for a minimum for 60 days.

· Paper documents received by the contractor with a stamp reading “SCANNED” shall NOT be scanned into CPRS - Vista Imaging, but shall be reviewed in VistA Imaging for quality control and if 100% accurate set aside for destruction. If quality of scanned VistA Image is less than 100% of paper document, document shall be rescanned and paper notated with “Re-Scanned – Delete Image” and sent to VA Palo Alto HIM Section for deletion.

· Indexing: Contractor shall utilize VistA Imaging document capture configuration and it is the responsibility of the VA to provide the contractor with access and training. Prior to scanning, all documents are reviewed to ensure proper patient identifiers are listed (i.e. patient name, last four digits of SSN, date of birth). All document types are to be identified through manual indexing or automated indexing which identifies each entry by patient, social security number, date of service and document type. Contractor identifies document type from a library of VA document titles. Contractor indexes documents based on VA requirements as specified from time to time.

· At a minimum there are six (6) data points required for indexing into Vista Imaging under the appropriate index term: date of document, document type, specialty, event/procedure, origin, and a free text description. Due to the variety of documents the Contractor shall review prior to scanning/indexing in order to determine the correct indexing values.

· Documents shall be imaged as an exact replica of the original document with quality control processes in place with assurance that the imaged document is stored, accessible, and retained according to the 75-year retention requirement.

· Contractor quality assurance reviews and productivity of contracting staff shall be reported to COR on a monthly basis. Deliverables to include evidence of 100% performance quality checks and quality assurance monitoring, workload reports on number of records and types scanned and indexed.

7.1.3. Provide storage of paper records, Nuclear Medicine Film Library, and pathology slides and blocks.

· Patient Health Record (Paper) Storage approximately 28,000 linear ft.: The active maintained paper record may be retrieved as needed subject to workflow agreement with the facility. Paper records will not be requested for routine daily use as the record is available electronically. Paper records are delivered fully assembled in accordance with VA chart assembly conventions.

Paper Health Record Inventory: Contractor will maintain a current electronic inventory of all paper records. The inventory includes patient full name, social security number and chart/accession volume number.

· Nuclear Medicine Film Storage: Nuclear medicine film jackets will be securely stored in the contractor’s NARA certified facility and retrievable by vendor owned transportation.

· Pathology Slide Storage: Pathology slides are to be securely stored in the contractor’s NARA certified facility. Slides shall be recalled in original form by accession number, type (Surgical, Cytology, Histology), and year.

Original Slide/block Request: Upon request from VAPAHCS, contractor will retrieve the original slides for pickup or shipping.

7.1.4. Emergency Paper Retrieval: Contractor shall be capable of retrieving and delivering paper records on an emergent basis twenty four hours a day and three hundred sixty five days per year. Records may be delivered in contractor owned and staffed vehicles, via facsimile, or via scanned document to VistA Imaging.

7.1.5. Document Destruction by the box: If the original documents received for imaging or filming are no longer required in paper, contractor shall provide document destruction services. The document destruction service shall include the shredding of all paper documents based on the retention period following the authorization of NARA and VHA RCS 10-1 together with the notification and approval of the VAPAHCS Record Management Officer (RMO).

Contractor shall adhere to VA Directive 6300, Destruction of Temporary Paper Records and VHA record disposition shall be entered on VA Form 7468 “Request for Disposition of Records. VHA RCS 10-1 or the GRS, or any other approved records schedule must be used to determine retention and disposition requirements for VHA records.

7.2. VA Health System is responsible for:

· Provide National Secure VPN connection for access to remote scan and index into VistA Imaging. The COR will request an Information Security Office (ISO) review of electronic system requirements for contractor remote access, if appropriate a VA National Security Office request will be prepared for a Virtual Private Network connection to VA Network.

· The request, receipt, transfer and distribution of paper records for those cases in which a paper record is required.

8. Record Management Requirements:

8.1. Contractor shall provide comprehensive box storage and indexing of all types of VA records and provide program management personnel who understand of the VA RCS 10-1 and the GRS. The size of the box is 15x10x12.The named NARA Certified Record Manager will provide a single point of contact for dealing with intake of new material, client education, and conversion requirements for new record type as well as general point of contact for the process. The Record Manager will:

· Train departments regarding storage processes, including procedures for storage and retrieval and customized labels for boxes sent to off-site storage.

· Provide labor to facilitate relocation of records to appropriate storage sites: National Archives, Federal Record Center, contractor’s NARA certified record center, or on-site storage.

· Facilitate conversion and user access to material held at the contractor NARA certified record center.

· Facilitate destruction of records beyond their VA specified retention period by notifying record custodians, obtaining required authorizations and destroying records.

· Inventory all boxes transitioned to contractor Record Center.

· Contractor shall provide an online ordering system that will allow users to order boxes electronically, document record type identification prior to submission, order labels for boxes and request record intake.

8.2. File Packing: Contractor shall provide an on-site file packaging services.

8.2.1. Project Setup: Contractor shall provide project management services to analyze, design and implement the required solution.

· Specification shall be created where appropriate that would encompass all aspects of the project:

1. types of records

1. estimated number of boxes/linear feet of records for storage

1. establish conversion of repository requirements for all record types

1. estimated disposition of boxes/linear feet on annual basis

1. projected costs for project, including relocation of records, storage, conversion, destruction and other disposition

8.2.2. Contractor shall provide record management and database indexing for box storage. Contractor shall provide self adhesive box labels, which will identify the NARA record series and include content descriptive, as well as a numeric accession number system of index

8.3. Record Storage: Contractor shall store boxes of records in a NARA certified facility.

8.3.1. NARA’s rigorous security and record protection requirements apply to all government agencies and vendors. 36 CFR 1228.156 provides procedures of what agencies should follow to transfer records to an agency records center or commercial records storage facility. Contractor will provide long-term or short term storage for records that do not require conversion to electronic form. The contractor certifies that all records are accessible on a 24-hour a day basis, 365 days per year.

The Record Center meets safekeeping standards- monitored and protected by security systems and smoke/heat detector systems in operation 24 hours per day.

Record storage complies with the CFR and USC (United States Code).

1. provide back office services

9. Contractor Personnel Security Requirements:

9.1. Contractor will obtain security clearances for all personnel who have access to VA records, whether in paper or electronic form. Employees must be cleared by VA security prior to starting VA related work which entails completion of the Questionnaire for Non-Sensitive Positions form and clearance via SIC-Security Investigations Center. Employees will then be processed for fingerprinting, Once cleared via VA, New User Access Authorization will be provided to contractor by VA. Contractor shall certify that all employees who do work for the VA have on file a confidentiality agreement. Furthermore, contractor shall have all employees participate in VA security training provided by the VA from time to time. Such training shall be offered at the contractor site.

9.1.1. Contractor shall provide each employee an identification badge which shall be displayed on the outer garment at all times. The badge shall include, as a minimum, the employee’s name and position title, and the contractor’s trade name. Contractor shall maintain a personnel numeric system for all employee badges and lost badges shall be reported to the COR in writing for access exclusion.

9.1.2. Contractor must possess all licenses, permits, accreditation and certificates as required by law.

Contractor shall bear the expense of obtaining background investigations from recruited personnel, including replacement personnel. Contractor shall pre-screen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship or legal alien status and are able to read, write, speak and understand the English language. Referencing FAR 52.222-54.

9.1.3. Contractor shall agree that all deliverables, associated working papers, and other material deemed relevant by the contractor in the performance of this task order are the property of the United States Government. Contractor shall agree that all individually identifiable health information shall be treated with the strictest confidentiality. Access to records shall be limited to essential personnel only. Records shall be secured when not in use. At the conclusion of the contract all copies of individually identifiable health records shall be destroyed or returned to the VA. Any individually identifiable health records shall be deleted from computers not belonging to the VA. The contractor shall comply with the Privacy Act, 38 U.S.C. 5701, 38 U.S.C. 7332, and 5 U.S.C. 552(a) et. seq. Contractor staff shall sign confidentiality statements as required. Contractor shall comply with all provisions of the Health Information Portability and Accountability Act (HIPAA) including but not limited to privacy, security of electronic health data, and adherence to standards and code sets as required by HIPAA. Contractor shall insure the confidentiality of all patient and employee information and shall be held liable in the event of breach of confidentiality.

9.1.4. Contractor staff must sign confidentiality statements as required. Any person, who knowingly or willingly discloses confidential information from the VA, may be subject to fines.

The Contractor shall make certain that appropriate physical care and security measures are taken to ensure that documents and health records and the VA information they contain are not damaged or compromised throughout the entire process from the point of receipt through the return shipment. The Contractor shall be compliant with all VA established security policies to ensure VA data, whether captured electronically or on paper or other media are not compromised. The Contractor shall adhere to established VA physical security policy prior to receipt and while in possession of documents and health records off and on-site.

19.1.5. In an event of customer complaint, the contractor shall provide a comprehensive written feedback to the COR and/or Contracting Officer via email.

10. Phase Out for Follow On Contracts.

In the event the Government awards a follow on contract to other than the incumbent contractor, the contractor will cooperate to the extent required to allow for an orderly changeover to the successor contractor. This transition shall be as smooth and transparent as possible to ensure no interruption in the services currently being provided.

Currently, we have approximately 28,000 linear feet of boxes federal records stored at the incumbent facility. The awardee shall be responsible for preparing, labeling and transferring all records stored from the incumbent’s facility without any cost to the government to ensure no interruption in the services being provided.

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/subcontrator 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.

j. The vendor 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 5 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 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 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/subcontractorowned 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 VAapproved 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 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 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 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 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…