DRAFT PWS-VISN 16 Secure DICOM Image Sharing Solution .pdf

VISN 16 Secure DICOM Image Sharing Solution

DRAFT Performance Work Statement (PWS)

1. Introduction. The Department of Veterans Affairs, South Central Veterans Integrated Service

Network 16 (hereafter referred to as VISN 16) requires a system that enables electronic, bi-directional exchange of radiology imaging exams and reports with commercial healthcare facilities providing services to VA patients. VISN 16 currently urilizes Medicom’s Imagex peer-to-peer network secure DICOM Image Sharing Solution for eight VA Medical Centers as listed in Table

1 below (Section 7).

2. Background. Implementation of the Mission Act has resulted in large numbers of Veterans obtaining imaging studies outside of VA, while continuing to receive clinical care within VA.

Effective and efficient VA-provided care depends upon timely access to these DICOM images. In addition, large numbers of Veterans obtain their imaging studies and/or specific care within the

VA but receive other care outside the VA. To obtain the best possible care, Veterans receiving care outside the VA are entitled and encouraged to share their VA-provided image studies with outside providers. Current image transfer solutions in either direction are cumbersome, inefficient, labor intensive, and result in substantial delays in patient care.

At present, DICOM images from outside providers are burned onto CD-ROMs and then either mailed or hand-carried from the provider to the VA. The process of then importing the images into the VISN 16 PACS program is time consuming and fraught with delay and misadventure—lost

CDs, dysfunctional CDs that cannot be accessed by VA systems, failures related to network security or systems incompatibility, and a host of other possible problems that cause delays. For image studies taken by the VA and shared with outside providers, the process described above runs in reverse but has the same inherent risks. In addition, there are significant supply and mailing costs when using CDs for image sharing.

The VA is developing a Veteran-centric medical record sharing system that will allow the export of images from the VA. While this system may be a viable solution in the long term, it requires a premium account and additional technology interfaces for Veterans to share these images with outside providers. It will be several years before this option gains widespread acceptance.

Furthermore, since it does not facilitate the importing of images into the VA, so it is still an incomplete solution.

Except for CDs that are mailed (which has its own set of risks and costs), each of the previously described methods places the burden for facilitating image sharing between VA and outside providers on the Veteran, who may be suffering from physical ailments and/or other personal situations. A truly “best care” system that gives Veterans control of their image sharing (through their authorization), but that does not make them directly responsible for accomplishing it, is preferable.

Medicom’s Imagex deploys a proprietary peer-to-peer network that would give the United States

Department of Veterans Affairs Hospitals the ability to electronically exchange data with the community. In so doing, Medicom’s Imagex has minimize delays in the delivery of care and reduce the operational costs associated with seeing a Veteran imaged outside of VA under the

Mission Act. By using the unique peer-to-peer secure network technology provided by Medicom, VISN 16 is able to retrieve the requested images from our community providers electronically, saving the time and cost of using courier services to transport the CD-ROMs to the Radiology File

Room.

3. Purpose. VISN 16 requires an efficient and cost-effective electronic image location, viewing, and transfer solution that will allow its facilities to bidirectionally share images with their community care partners, thereby greatly reducing the need for burning images too, and importing images from, CDs.

4. Scope. VISN 16 intends to award a indefinite delivery indefinite quantity (IDIQ) contract to the overall best-value contractor capable of meeting the requirements and objectives outlined herein similar to Medicom’s Imagex peer-to-peer network secure DICOM Image Sharing Solution system, the associated installation and configuration services, and the incorporated staff training requirement. Contract will include any and all software, approvals, testing, and training of the new system at all applicable facilities and all current and future identified community partners that are willing to participate. Offerors must demonstrate the performance capabilities detailed throughout this document

5. Period of Performance. The period of performance shall be one (1) twelve (12) month base period and four one year ordering periods.

6. Hours of Coverage & Federal Holidays. Maintenance Service will be provided during regular coverage hours of 8:30am to 5:30pm, Monday through Friday, excluding federal holidays. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises. Federal Holidays are:

New Years' Day Martin Luther King Day Presidents' Day

Memorial Day Independence Day Labor Day

Columbus Day Veterans' Day Thanksgiving Day

Christmas Day

7. Place of Performance. Contract performance shall take place at the VISN 16 locations shown in Table 1 and at all current and future community care partners that are identified by the

VISN 16 facilities and who agree to participate in Imagex peer-to-peer network secure DICOM

Image Sharing solution.

Table 1. VISN 16 Facilities

Facility Address

Alexandria Veterans Health Care System 2495 Shreveport Hwy

Pineville, LA 71360

Gulf Coast Veterans Health Care System 400 Veterans Avenue

Biloxi, MS 39531

Veterans Health Care System of the Ozarks 1100 N. College Avenue

Fayetteville, AR 72703

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd

Houston, TX 77030

G.V. (Sonny) Montgomery VA Medical

Center

1500 E. Woodrow Wilson Drive

Jackson, MS 39216

Central Arkansas Veterans Healthcare System

John L. McClellan Memorial Veterans

Hospital

4300 West 7th Street

Little Rock, AR 72205-5484

Southeast Louisiana Veterans Healthcare

System

2400 Canal Street

New Orleans, LA 70119

Overton Brooks VA Medical Center 510 E. Stoner Ave.

Shreveport, LA 71101-4295

8. Requirements. The requirements for the VISN 16 Imagex peer-to-peer network secure

DICOM Image Sharing Solution system are detailed below. Offerors shall provide narrative descriptions of how they will meet these requirements and objectives.

a. The required services shall integrate with VistA Imaging Importer, Commercial PACS, VistA Imaging, Computerized Patient Record System (“CPRS”), Laurel Bridges’ Compass

DICOM router or any other DICOM router provisioned by the VA, and Cerner which will be implemented in the future.

b. The Radiology department currently uses software to import images from CD-ROMs received by the VA. The current importing process, which uses VistA Importers allows the user to select either a CD-ROM or directory on the workstation containing DICOM images and import them to VistA Imaging and Commercial PACS. The acquired network services shall ensure the VA can continue to save these images to Commercial PACS and to VistA

Imaging. The acquired services must authenticate and validate bi-directional, electronic exchange of DICOM images, Radiology reports, and Radiology orders using a FIPS 140-

2 validated cryptographic methodology.

c. Contractors service/system shall allow the Radiology department to search the commercial imaging providers located within the VISN 16 service area, locate prior medical images and reports, and retrieve them to the VA where they can be inducted to VA systems using a quality assurance step.

d. In addition, the system shall automatically match patient IDs to update the patient’s MRN

# with the VA’s MRN #, when possible. Further, the system must generate a non-VA order through VistA Imaging in CPRS and update the inbound studies with the VA accession number for reconciliation in Commercial PACS. In some cases, these studies may be stored through Compass DICOM Router.

e. The acquired service/system shall directly increase the workflow for importing Radiology exams into VistA Imaging and Commercial PACS.

f. Contractor shall provide a system that facilitates the exchange of medical images and reports through encrypted, peer-to-peer conduits between providers on a federated health information network by way of the FIPS 140-2 validated Site-to-Site connection.

g. The system shall provide enhanced automation that:

a. Utilizes an upcoming appointment, procedure, or community consult to automatically pre-fetch relevant images and reports from commercial or private sector imaging providers relevant to the upcoming care event.

b. Conducts patient matching to automatically match inbound data to an existing patient and generate an order to obtain a VA accession number.

c. Handles electronic requests that allow community care providers to request information electronically instead of sending a fax to the VA.

d. Gives the VISN 16 the ability to request and conduct a broadcast query of the private sector providers to locate prior images and reports conducted through a care in the community program.

e. Facilitates order generation and retrieval of results from community care providers, opposed to calling community care providers to track down patient results and wait on a fax.

f. Supports advanced integrations with DICOM, FHIR, API, and HL7 standards.

h. The Contractor’s solution shall allow the Radiology department to search the commercial imaging providers located within the VISN 16 service area, locate prior medical images and reports, and retrieve them to the VA where they can be inducted to VA systems using a quality assurance step. In addition, the system must automatically match patient IDs to update the patient’s MRN # with the VA’s MRN #, when possible. Further, the system must generate a non-VA order through VistA Imaging in CPRS and update the inbound studies with the VA accession number for reconciliation in Commercial PACS using a

Class 2 interface deployed to each VistA Instance.

i. The Contractor’s solution shall deploy a network that gives the VHA the ability to bi-directionally exchange medical images and diagnostic reports with the community and there shall be no cost for private sector facilities to exchange images bi-directionally with the VA.

j. The Contractor’s solution shall provide a fully functional search engine that gives the VA the ability to locate, access, and use medical images, reports even when the Care in the

Community location is unknown. The patient query must use four-points of patient identification.

k. The Contractor’s solution shall allow for automated pre-fetch of prior images and reports from the CITC facility or in advance of an upcoming appointment at the VA or during a care in the community consult.

l. The Contractor’s solution shall deploy an automated processes for importing images and reports using a Class 2 HL7 interface with VistA.

m. When outside images and reports are received, the Contractor’s solution shall attempt to automatically find the correct patient in VistA/CPRS and reconcile the outside data with the correct Patient ID/MRN. If a distinct match is not found, the outside data can be held for manual review by staff in a worklist.

n. The Contractor’s solution shall automatically conduct searches of private sector facilities for relevant priors based on an upcoming appointment/procedure using an HL7 order

(ORM) or scheduling (SIU) message from VistA.

o. The Contractor’s solution shall search private sector facilities on the Network for the patient, retrieve clinically relevant prior images and documents, reconcile the priors, and store the priors in VistA Imaging and Commercial PACS.

p. The Contractor shall be able and willing to pay for infrastructure and implementation costs at private sector facilities and should have policies and a history of performance with the VHA regarding covering the cost of private sector facility's hosting, HL7 integration, and DICOM connectivity.

q. The Contractor’s solution shall be fully federated and shall not hold or pass any VHA data in or through a cloud or hosted environment for storage, viewing, or processing.

Furthermore, the Contractor’s solution must not require the use of cloud technology or

FedRamp cloud certification to work as intended.

r. The Contractor shall have a National MoU/ISA, a National BAA, and an established

National S2S connection in place as well as past performance references to validate these items are established prior to contract award.

s. Offerors shall provide documented past performance demonstrating capability to meeting all information security requirements for deploying the service.

t. Offerors shall provide past performance references for deployment of advanced automation solutions such as Automated Federated Search, Patient Matching, Automated

Internal Pre-fetch, and Electronic Requests.

u. The Contractor shall provide proof of past performance regarding its ability to use an upcoming VA Care in the Community Appointment to automatically query the network of providers and retrieve health information relevant to an upcoming VA care event.

v. The Contractor shall provide and deploy a secure electronic image location, viewing, and transfer technology solution at all VISN 16 facilities listed in Table 1.

w. The Contractor-provided solution shall offer VA hospitals the option of electronically searching, accessing, and exchanging data with community providers.

x. The Contractor-provided solution shall allow for rapid access to essential imaging data and improved efficiency, and reduction in operational costs associated with medical image sharing.

y. The Contractor’s solution shall be able to operate within a virtual environment and shall not require the installation of additional physical hardware within the VA.

z. The Contractor shall provide a VPN endpoint gateway that can connect to any VA

Trusted Community Care provider (private sector facility) through the Contractor’s provided network.

aa. The Contractor shall implement the system at all current and future community care partners identified by any VISN 16 facility listed in Table 1, if the partner is willing to accept the solution.

bb. The Contractor shall allow for an unlimited number of community care partners identified by VISN 16 or its facilities, to access the system, at no additional cost to either the VA or the partners.

cc. The Contractor’s solution shall provide a method for sharing VA images with patients and with any providers outside the network; regardless of their ability to share their images back to VA.

dd. All software shall be approved in the VA OIT TRM at time of contract award and shall meet network security and Enterprise Risk Analysis requirements at time of award or within a reasonable time after award as determine by the VA. Failure to obtain these approvals within a reasonable time after award, as determined by the VA, shall result in termination of the contract.

ee. The Contractor-provided software solution shall be approved in the VA OIT Technical

Resource Manual at time of award. The Contractor shall certify in their response that the specific product and software version offered is approved in TRM before contract award.

ff. The Contractor’s solution shall interface with VISN 16’s commercial PACS

(Philips/Carestream Vue PACS V. 12.2) and with VistA Imaging.

gg. Once implemented, the Contractor’s solution shall provide the ability to serve as a single platform for exchanging medical images with any participating private sector facility designated as Trusted by a local system administrator.

hh. The Contractor’s solution shall provide a search engine that shall enable VISN 16 facilities to:

a. Broadcast a search when the location of a patient’s information is unknown.

b. Perform a targeted search when specific and known patient information is needed.

c. Push images to VA Trusted Community Care providers

ii. The Contractor’s solution shall automate the workflow for prefetching priors from the community and matching the inbound data to existing patients.

jj. The Contractor’s solution shall not require the use of any cloud-based components in any capacity for the delivery of the solution nor store or host any VA PHI or PII on its servers.

kk. As part of this contract, the Contractor shall provide an annual maintenance and support services agreement for all covered VISN 16 facilities. This support and service agreement shall include on-going training and outreach services.

ll. The Contractor’s solution shall meet or exceed HIPPA and HITECH Act requirements for ePHI.

mm. Where applicable, the Contractor’s solution will be compatible with current and future

VA electronic systems to include, but limited to, VistA/CPRS electronic record system, Philips/Carestream commercial PACS, Barco QA Web, Joint Legacy Viewer, and

Windows Operating Systems.

nn. In addition, the VA anticipates deploying the Cerner electronic medical record system at all sites within VISN 16 in the future. The Contractor’s solution must be compatible with

Cerner and the Contractor’s annual support agreement shall provide integration and migration services if/as necessary to migrate the connectivity from VistA to the Cerner platform.

oo. The implementation of the services/requirements described in this PWS shall be completed no later than 150 days after award for all facilities listed in Table 1.

Government-caused delays do not count toward this 150-day limit.

pp. Contractor will be required provide with its quote, an implementation plan or framework for working with VA facilities to integrate its solution with the community partners.

Specific plans and schedules for integrating community partner facilities shall be agreed upon by VA and the Contractor post-award.

9. Privacy and Security requirements. All Offerors shall submit a fully completed VHA form

6550 with their submission package. The device shall be able to obtain 6550 security clearance and enterprise risk analysis approval. All software utilized must be included on the approved

Technical Reference Model website (TRM). Contractors who remotely access the device tor maintenance, patching, troubleshooting, and so forth shall comply with VA security regulations.

Additional Contractor Security and Privacy Requirements from VA Handbook 6500.6 are listed below.

a. 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.

b. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS-

i. 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.

ii. 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.

iii. 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.

iv. 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.

v. 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.

c. VA INFORMATION CUSTODIAL LANGUAGE –

i. 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).

ii. 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.

iii. 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.

iv. 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.

v. 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.

vi. 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.

vii. 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.

viii. 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.

ix. 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.

x. 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.

xi. 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.

xii. Contractor shall understand and implement the IT security requirements for system interconnection documents required per the Memorandum of Understanding or

Interconnection Agreement (MOU-ISA). The standard operating procedure (SOP) and a template for a MOU-ISA are located on the Information Protection Risk

Management (IPRM) Portal and can be provided to the contractor.

xiii. Contractor shall understand their participation in IT security requirements for C&A of the VA system to which they connect.

d. SECURITY INCIDENT INVESTIGATION-

i. 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.

ii. To the extent known by the contractor/subcontractor, the contractor or 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.

iii. 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.

iv. 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.

e. LIQUIDATED DAMAGES FOR DATA BREACH-

i. 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.

ii. 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.

iii. 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;

c. Number of individuals affected or potentially affected;

d. Names of individuals or groups affected or potentially affected;

e. Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text;

f. Amount of time the data has been out of VA control;

g. The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

h. Known misuses of data containing sensitive personal information, if any;

i. Assessment of the potential harm to the affected individuals;

j. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and

Privacy Incidents, as appropriate; and

k. 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.

3.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:

a. Notification;

b. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c. Data breach analysis;

d. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

f. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

f. TRAINING –

i. 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:

1.Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

2.Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

3.Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

4.Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g. any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security

Training Requirements.]

ii. 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.

iii. 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.

10. MEDICAL RECORDS REQUIREMENTS.

a. Authorities: Contractor’s physician (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of

Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

b. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA for Covered Entity to disclose Protected Health

Information to: a health care provider for treatment. Based on this exception, a

BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’

(24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by

VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense.

Contractor shall deliver all final patient records, correspondence, and notes to the

VA within twenty-one (21) calendar days after the contract expiration date.

c. Disclosure: Contractor’s physician(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over

Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook

1907.01, Health Information Management and Health Records and VHA

Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

d. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information

Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 and all guidelines provided by the VAMC.

e. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the

Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and

Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for http://www.rms.oit.va.gov/SOR_Records/24VA19.asp http://www.rms.oit.va.gov/SOR_Records/24VA19.asp https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://vaww.va.gov/vaforms/va/pdf/VA3288.pdf https://vaww.va.gov/vaforms/va/pdf/VA3288.pdf locating and forwarding records not kept at their facility. The VA’s Release of

Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and

Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer.

11. Travel for Installation, Implementation and Training. Any Contractor personnel travel related to this contract shall be incorporated into the overall firm fixed price for the contract. No travel costs will be reimbursed by VA.

12. Government Furnished Equipment/Information. The Contractor shall be allowed access to Government equipment including servers and network infrastructure. Information on

Government equipment and systems shall be provided as necessary. No Government-owned property will be transferred into the Contractor’s control. Additional software products may be provided by the Government as identified to facilitate Contractor access.

13. Invoicing. Invoices shall be submitted electronically via the Financial Services Center

Mandatory Electronic Invoice System, on a monthly basis. Invoices must include, at a minimum, the following information: Contractor name, purchase order number, period of service the billing covers, and a list of equipment items covered during the stated period of performance. This requirement is in accordance with VARR Clause 852.232-72 Electronic

Submission of Payment Requests: http://www.fsc.va.gov/einvoice.asp. Electronic payments are net 30 days.

https://vaww.va.gov/vaforms/medical/pdf/10-5345.pdf https://vaww.va.gov/vaforms/medical/pdf/10-5345.pdf http://www.fsc.va.gov/einvoice.asp