Imaging Software Description of Need.docx

Description of Need

Introduction:

This requirement is for software which enables electronic, bi-directional exchange of radiology imaging exams and reports with commercial healthcare facilities providing services to VA patients.

Background:

The Mission Act has made it possible for Veterans to seek diagnostic imaging services outside of the VA. As a result, diagnostic results, which are in the form of DICOM images and textual reports, need to be couriered back to the VA for further patient care. As it exists currently, CD-ROMs and DVD-ROMs are hand-carried or mailed to and from the VA at the completion of a diagnostic test; this causes bottlenecks and delays in the continuity of Veteran care. There has also been a delay in archiving the images, delivered to the ordering provider by the patient who diligently obtains the requested images from the outside provider on a CD-ROM. The VA relies on CDs to share imaging examinations with community care providers, but examinations are often repeated when CDs are not requested, get misplaced, or are not “readable” due to software incompatibility. CDs and repeat imaging cost the VA an estimated $163-181 million per year, nationally. But more importantly, the Veteran can be harmed when previous examinations are not available: delayed diagnosis of cancer, aggressive and needless workups, and increased radiation exposure.

Scope/Required Service/Performance Statement:

The required software must integrate with VistA Imaging Importer, Agfa Impax, VistA Imaging, Computerized Patient Record System (“CPRS”), Laurel Bridges Compass DICOM router, and Cerner which will be implemented in the future. 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 Agfa Impax. The software must ensure the VA can continue to save these images to Agfa Impax and to VistA Imaging. The software must authenticate and validate bi-directional, electronic exchange of DICOM images, Radiology reports, and Radiology orders using a FIPS 140-2 validated cryptographic methodology. The software must allow the Radiology department to search the commercial imaging providers located within the VISN 19 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 software 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 Agfa Impax. In some cases, these studies may be stored through Compass DICOM Router.

The image transfer process will occur as follows:

· Receive Information at the VA

· A one-time setup is initiated, and a trust with various permission sets is formed with outside facilities through the system. The system can have an unlimited number of trusted connections to the private sector through this single acquisition and through a single MoU/ISA with the service provider.

· A query or request will be initiated by the VA through the software:

· This query can be end-user initiated or initiated automatically by the acquired system based on an upcoming appointment, a care in the community consult, an upcoming Radiology procedure, or an admittance to the hospital.

· The query is broadcasted to the entire community of providers participating in the health information network.

· The prior medical images and reports are located at outside facilities.

· The images and reports are retrieved from the outside facility using DICOM, FHIR, proprietary APIs, HL7, and other methods which are available in a web-portal.

· The images and reports are sent through a one-time-use conduit negotiated through the internet and terminating through a Site-to-Site VPN with the TIC.

· The images are downloaded to the local system at the VISN.

· The local system attempts to match the correct patient demographics, update the patient ID, generate an order, and import the studies and reports with the VA MRN and a VA Accession number.

· In cases where this automated reconciliation process fails, the system provides a mechanism for modifying this information before importing it.

· Sending information to the private sector:

· A one-time setup is initiated, and a trust with various permission sets is formed with outside facilities through the acquired system. The system can have an unlimited number of trusted connections to the private sector through this single acquisition and through a single MoU/ISA with the service provider

· The private sector facility can place a request through a portal.

· The file room at VISN 19 will be notified of the request.

· The VA employee can initiate a query of the VA systems to identify whether any studies exist which meet the specifications of the request.

· If no studies exist, the request can be rejected.

· Once the internal query is complete, the staff can select studies and reports which meet the specifications and initiate sharing with the outside facility.

· The system will package and send the images and reports through the direct conduit through the internet to the outside provider by way of the Site-to-Site VPN.

· The commercial provider will receive the images and the acquired system can automatically import the images to private sector facility’s PACS and EMR.

In all the above cases, there is no cost to the private sector or commercial facilities and there is no limit on workflow. Furthermore, information can be exchanged bi-directionally with no limitation on volume.

In summary, the software 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. The software provides enhanced automation which:

· 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.

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

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

· Gives the VA 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.

· 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.

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

Supported Locations:

· Eastern Colorado VA Health Care System Rocky Mountain Regional VA Medical Center (1700 N Wheeling St, Aurora, CO 80045) Alamosa/Sierra Blanca Clinic (622 Del Sol Drive, Alamosa, CO 81101) Aurora Outpatient Clinic (13701 E Mississippi Ave #200, Aurora, CO 80012) Burlington Telehealth Clinic (1177 Rose Avenue, Burlington, CO 80807) Denver Vet Center (7465 East First Avenue Suite B, Denver, CO 80230) Golden Outpatient Clinic (1020 Johnson Road, Golden, CO 80401) Jewell Clinic (14400 E Jewell Ave, Aurora, CO 80012) La Junta Outpatient Clinic (1100 Carson Ave., Suite 104, La Junta, CO 81050) Lamar Outpatient Clinic (1401 South Main Street, Suite 2, Lamar, CO 81052) PFC Floyd K. Lindstrom VA Clinic (3141 Centennial Boulevard, Colorado Springs, CO 80907) Pueblo Outpatient Clinic (4776 Eagle ridge Circle, Pueblo, CO 81008) Salida Telehealth Clinic (920 Rush Drive, Salida, CO 81201)

· Eastern Oklahoma VA Health Care System Jack C. Montgomery VA Medical Center (1011 Honor Heights Drive, Muskogee, OK 74401) Ernest Childers VA Outpatient Clinic (9322 E. 41st St., Tulsa, OK 74145) Jack C. Montgomery East Clinic (2414 E. Shawnee Bypass, Muskogee, OK 74403) McAlester VA Outpatient Clinic (2 E. Clark Bass Blvd, McAlester, OK 74501) McCurtain County CBOC (903 SE Washington St., Idabel, OK 74745) Tulsa Behavioral Medicine Clinic (10159 E 11th Street, Tulsa, OK 74128) Vinita Outpatient Clinic (269 S 7th St, Vinita, OK 74301) Tulsa VA Dental Clinic (5110 South Yale, Suite 200, Tulsa, OK 74135)

· Oklahoma City VA Health Care System Oklahoma City VA Medical Center (921 N.E. 13th Street, Oklahoma City, OK 73104) Ada CBOC (717 Better Now Plaza, Ada, OK 74820) Altus VA Clinic (1604 N. Main, Highway 283, Altus, OK 73521) Ardmore VA Clinic (2002 12th Ave NW, Suite E, Ardmore, OK 73401) Blackwell VA Clinic (1009 W. Ferguson Ave., Blackwell, OK 74631) Enid VA Clinic (401 S. 3rd St., Enid, OK 73701) Lawton/Ft. Sill VA Clinic (4303 Pittman and Thomas, Building 4303, Fort Sill, OK 73503) North May Oklahoma City VA Clinic (2915 Pine Ridge Road, Oklahoma City, OK 73120) South Oklahoma City VA Clinic (7919 Mid America Blvd., Oklahoma City, OK 73135) Stillwater VA Clinic (320 N. Perkins Avenue, Stillwater, OK 74074)

· Montana VA Health Care System Fort Harrison VA Medical Center (3687 Veterans Drive, Fort Harrison, MT 59636) Anaconda VA Clinic (118 East 7th St., Suite 2A, Anaconda, MT 59711) Benjamin Charles Steele VA Clinic (1766 Majestic Lane, Billings, MT 59102) Bozeman VA Clinic (300 N. Willson, Suite 703G, Bozeman, MT 59715) Cut Bank VA Clinic (#8 2nd Ave SE, Cut Bank, MT 59427) Missoula VA Clinic (2687 Palmer St., Suite C, Missoula, MT 59808) Glasgow VA Clinic (630 Second Ave. South, Suite A, Glasgow, MT 59230) Glendive VA Clinic (2000 Montana Ave., Glendive, MT 59330) Great Falls VA Clinic (1400 29th Street South, Suite 1, Great Falls, MT 59405) Hamilton VA Clinic (299 Fairgrounds Suite A, Hamilton, MT 59840) Kalispell VA Clinic (31 Three Mile Dr., Suite 102, Kalispell, MT 59901) Lewistown VA Clinic (629 NE Main St., Suite 1, Lewistown, MT 59457) Merril Lundman VA Clinic (130 13th Street, Suite 1, Havre, MT 59501) Miles City VA Clinic and Community Living Center (210 S. Winchester, Miles City, MT 59301) Plentywood VA Clinic (440 West Laurel Ave., Plentywood, MT 59254)

· Salt Lake City VA Health Care System George E. Wahlen VA Medical Center (500 Foothill Drive, Salt Lake City, UT 84148) Elko VA Clinic (2719 Argent Ave. #9, Elko, NV 89801) Idaho Falls VA Clinic (640 South Woodruff, Idaho Falls, ID 83401) Ogden VA Clinic (982 Chambers Street, South Ogden, UT 84403) Orem VA Clinic (1443 West 800 North, Suite #302, Orem, UT 84057) Pocatello VA Clinic (500 S 11th Ave, Pocatello, ID 83201) Price VA Clinic (189 South 600 West, Suite B, Price, UT 84501) Roosevelt VA Clinic (245 West 200 North, Roosevelt, UT 84066) St. George VA Clinic (230 North 1680 East, Building N, St. George, UT 84790) Weber County VA Clinic (5957 Fashion Pointe Dr. Suite 103, South Ogden, UT 84403) Western Salt Lake VA Clinic (2750 South 5600 West, West Valley City, UT 84120)

· VA Western Colorado Health Care System Grand Junction VA Medical Center (2121 North Avenue, Grand Junction, CO 81501) Glenwood Springs Community Clinic (2425 South Grand Ave, Suite 101, Glenwood Springs, CO 81601) Craig VA Clinic (1111 West Victory Way, Suite 116, Craig, CO 81625) Moab Veterans Community Clinic (702 South Main Street, Suite 5-B, Moab, UT 84532) Montrose Veterans Community Clinic (154 Colorado Avenue, Suite 100, Montrose, CO 81401)

· Cheyenne VA Health Care System Cheyenne VA Medical Center (2360 E. Pershing Blvd., Cheyenne, WY 82001) Laramie Mobile Telehealth Clinic (2901 Armory Road, Laramie, WY 82702) Fort Collins Outpatient Clinic (2509 Research Blvd., Fort Collins, CO 80526) Loveland Community Clinic (5200 Hahns Peak Drive, Loveland, CO 80538) Rawlins PCTOC (1809 East Daley Street, Rawlins, WY 82301) Sidney VA Outpatient Clinic (1116 10th Ave, Sidney, NE 69162) Torrington Mobile Telehealth Clinic (908 West 25th Ave., Torrington, WY 82240) Wheatland Mobile Telehealth Clinic (759 East Cole Street, Wheatland, WY 82201)

· Sheridan VA Health Care System Sheridan VA Medical Center (1898 Fort Road, Sheridan, WY 82801) Afton Outreach Clinic (125 South Washington, Afton, WY 83110) Casper Outpatient Clinic (4140 S. Poplar Str., Casper, WY 82601) Cody Outpatient Clinic (1432 Rumsey Avenue, Cody, WY 824214) Evanston Primary Care Outreach Clinic (1565 South Highway 150 #E, Evanston, WY 82930) Gillette Outpatient Clinic (604 Express Drive, Gillette, WY 82718) Riverton Outpatient Clinic (2300 Rose Lane, Riverton, WY 82501) Rock Springs Outpatient Clinic (1401 Gateway, Rock Springs, WY 82901) Worland Primary Care Outreach Clinic (510 South 15th., Suite D, Worland, WY 82401)

INFORMATION SECURITY/PRIVACY REQUIREMENTS

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. 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. 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.

c. 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.

d. 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.

e. 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.

f. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted for, using VA-approved encryption tolls that are, at minimum, FIPS 140-2 validated.

g. 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.

h. 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.

4. 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.

5. 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 $20,00.00 coverage at $0 deductible; and

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

6. 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:

(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 Privacy and Information Security Awareness and Rules of Behavior training and annually complete required Privacy and HIPAA Training; and

(3) Successfully complete any additional information security or privacy training, as required for VA personnel with equivalent information system access.

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.