DRAFT PWS- Medical Calculators SaaS.pdf

B.3 PERFORMANCE WORK STATEMENT

TITLE: SOFTWARE LICENSING OF AUTOMATED CLINICAL

CALCULATORS FOR REAL-TIME DECISION SUPPORT IN CLINICAL

WORKFLOWS

1. BACKGROUND

Clinical Decisions Support (CDS) tools help clinicians make informed decisions at the point of care. The Clinical Decision Support Collaborative (CDSC) seeks to maximize clinicians’ and veterans’ abilities to collaboratively achieve veteran health goals, providing clinicians with context-relevant, patient-specific information to enhance decision-making within the clinical workflow. While many clinical decision support capabilities are available directly within CPRS or Oracle Health, the CDS Collaborative focuses on opportunities for clinical decision support that are not provided within the Electronic Health Record (EHR).

The program serves clinicians by creating a suite of context-aware, standards based Clinical Decision Support (CDS) tools that provide a common, cohesive user experience and integrate with CPRS as well as Oracle Health.

The program also serves innovators in the field wishing to create CDS applications, by providing them with an underlying platform and set of development tools and services to facilitate and accelerate the creation of such applications.

Office of the Chief Technology Officer (OCTO) and the Office of Health Informatics (OHI) have developed and implemented CDS console to host clinical applications with the capability of connecting directly to the electronic health record (EHR) and other data systems. VA has internally developed CDS applications, on-boarded Government Off-the-Shelf (GOTS) and looks to incorporate Commercial Off-the-Shelf (COTS) applications in the future for use in this platform.

In FY24 the Clinical Decision Support Console and associated apps have rapidly increased value delivered. The CDS Console has been installed at and used at every VA facility. Patients viewed per month has increased from 48,300 (9/23) to 123,600 (9/24). By the end of FY24, CDSC has serviced 20,000 unique users with data on 997,000 patients. Apps deployed increased from 4 to 11.

Clinical calculations and risk scores, one type of CDS, can help inform patient outcomes such as risk of in-hospital mortality or risk of readmission, and ultimately help the provider make better decisions regarding diagnosis and treatment, which ultimately improves outcomes and reduces costs. However, these often-complex evidence-based calculations use myriad patient-specific clinical parameters as inputs making manual calculation tedious. CDS Calculators that pull data from the EHR automatically can simplify, accelerate, and improve the accuracy of calculations for clinical scores or measures.

The goal of this work is to integrate and implement a third-party CDS application directly into clinical workflows using the CDS Console. The expected outcomes of this project are improved Veteran clinical outcomes and improved quality of life and job satisfaction for providers using VA health information systems.

The contractor shall provide Clinical Calculator Clinical Decision Support as a managed service hosted within the VA Enterprise Cloud (VAEC). Clinical calculators use patient data to perform calculations such as clinical risk assessments that are vital to and ubiquitous in-patient care.

Currently, many clinicians have smart phone-based clinical calculators and waste time manually entering patient data into the app and transferring results into their clinical documentation.

Under this contract the contractor shall provide clinical calculator software and appropriate standards-based interfaces to enable calculations to be performed without re-keying of veterans’ data.

The purchased managed service will be utilized to provide medical calculations and risk assessments at the point of care for Clinical Decision Support. No funding from this contract will be used to support IT functions. This acquisition is to be funded with non-IT funds under Directive 6008 Appendix A, page 30, item 39. MS funding is to be used for initiatives that will result in CDS products distributed to the point of care for direct clinical use.

2.0 SCOPE OF WORK

The primary goal is to integrate CDS calculators and risk assessments with underlying EHRs and existing applications and grant access to all VA clinicians at the point of care in order to increase care quality and safety and enhance clinician efficiency.

The CDS Calculator application will read patient demographic and clinical data from the EHR utilizing existing FHIR interfaces. EHR data will be used pre-populate relevant input fields to provide medical calculations. Initially, results will just be displayed to clinicians but will not automatically be stored or written back to the patient record in VistA through an API, though this functionality may be implemented in the future. Within the application, numerous clinical calculations and risk assessments will be supported.

The vendor will collaborate with VA OI&T to provide information necessary for the VA to integrate the CDS Clinical Calculator application within the VA CDS Platform.

2.1 SOFTWARE AND IMPLEMENTATION REQUIREMENTS:

a. Must be implemented and installed on VA-controlled infrastructure (VAEC) and operate within the limitations and policies established by VA Information Security and other authorities, such as Federal Information Security Modernization Act (FISMA)

b. Calculations and risk scores must be available via API for integration within existing CDS applications to enable Must be able to support custom frontend design and UX to match VA needs and requirements.

c. Must adhere to and stay compliant with SMART on FHIR interoperability standards as well as International Classification of Diseases revision 10 (ICD-10), Systematized

Nomenclature of Medicine (SNOMED), and Logical Observation Identifiers Names and Codes (LOINC)

d. Must support Docker containerization of all software components and resources in the stack producing containers compliant with Amazon Elastic Container Service (Amazon ECS) GovCloud

e. Must provide frequent updates and support to the containers running in the VA infrastructure related to security issues and performance issues.

f. Container images must pass routine security scans which identify known Common Vulnerabilities and Exposures (CVEs). The vendor is expected to address these vulnerabilities within one week to High impact vulnerabilities, and 72 hours for Critical vulnerabilities. Low and Medium impact vulnerabilities should still be addressed in a timely manner in conformance to VA infrastructure requirements.

g. Must support running completely isolated from external network resources and only access its own internal VA-hosted resources in a private cloud.

h. Must provide guidance, technical diagrams, and direct support to the VA infrastructure and development staff in creating a pipeline, deploying initial resources, updates, and environment configurations required for the application to run optimally on premise.

i. Must provide updates to medical calculation and risk assessment including formulas, fields, algorithms, clinical guidelines to stay consistent with current clinical practices; this includes calculator versions; formulas and algorithms are up to date on latest calculator version; data mappings for conditions; data mappings for labs and vitals; calculator recommendations based on latest scientific literature; clinical content guidelines; clinical content resources; proper results to display; and score interpretation tables

j. Must conform to existing EHR FHIR specification.

k. Must provide the ability to accommodate for data mapping variabilities across different VA Stations.

l. Must be flexible to allow adding specific calculators that may or may not be proprietary to the VA, as well as features required for usability and security compliance.

m. Must be SMART on FHIR compliant and support EHR-launch from VA SMART on FHIR app platform.

n. Must support fetching patient problems defined in SNOMED CT US terminology, and triggering the required Workflows and Calculators that apply to that context.

o. Must maintain mapping between ICD-10 and SNOMED per SNOMED mapping resources.

p. Must be able to configure and integrate new evidence-based calculators within one month of request.

q. Must be able to provide medical subject matter expert to assist in supporting and troubleshooting calculator design.

r. Must be able to provide biomedical informatics subject matter expert to assist in supporting and troubleshooting calculator development.

s. Must be able to respond to emergent issues within 6 hours and non-emergent issues within 48 hours during normal business hours.

t. Must be able to configure custom calculators based on VA initiatives and physician requirements.

u. Access to evidence-based medical calculators must be automatically recommended to clinician in real time based on SNOMED-CT and ICD-10 mappings.

v. Data in EHR must be mapped via LOINC, ICD-10, SNOMED-CT, and other interoperability standards required by the VA to as many calculator input fields (criteria) automatically as possible, so clinicians don't have to manually fill out the calculators.

w. Calculators must be transparent and based on validated research.

x. Recommended results must allow clinicians to apply to note with ease.

y. Clinician must have ability to run evidence-based calculations manually.

z. Must provide an on-premise analytics dashboard to track and monitor disease management across patient populations

aa. Must be able to monitor, filter, view and create custom reports of calculator usage; this includes making utilization data accessible.

bb. Must do a free proof of concept integration of the application into VA SMART on FHIR app platform (via a SMART on FHIR launcher) to demonstrate compliance with SNOMED-CT, ICD-10, and LOINC automations are behaving as expected.

cc. The software will capture usage statistics which will be available to VA stakeholders for review and analysis.

dd. The software vendor will provide dedicated support during the pilot.

ee. The software vendor will work with clinical stakeholders to identify further use cases of the tool that can be scoped for a potential pilot.

3. CONTRACT TYPE

This is a firm fixed price order.

4. PERIOD OF PERFORMANCE

The period of performance is base plus four (4) one (1) year option periods to begin after award.

5. PLACE OF PERFORMANCE

The tasks under this PWS shall be performed remotely or at the location of choice by the Vendor. The CDS application shall be deployed in the production environment in the Amazon Web Services (AWS) VA Enterprise Cloud environment (VAEC)

6. TRAVEL

The Government does not anticipate travel under this effort. Travel must be pre-approved in writing by the Contracting Officer’s Representative (COR) and in accordance with Federal Travel Regulations. Each Contractor invoice must include copies of all receipts that support the travel costs claimed in the invoice. Local travel within a 50-mile radius from the contractor’s facility is considered the cost of doing business and will not be reimbursed. This includes travel, subsistence, and associated labor charges for travel time. Travel performed for personal convenience and daily travel to and from work at the Contractor’s facility will not be reimbursed.

Travel, subsistence, and associated labor charges for travel time for travel beyond a 50-mile radius of the Contractor’s facility are authorized for reimbursement on a case-by-case basis and must be pre-approved by the COR and must be planned and executed according to Federal Travel Regulations. General and Administrative expenses will not be reimbursed.

The FTR can be referenced at:

http://www.gsa.gov/portal/ext/public/site/FTR/file/FTRTOC.html/category/21865/hostUri/portal

7. TASK STATEMENT

Tasks performed shall be of a non-personal nature. VA organizations will not provide supervision of contractor personnel. Contractor personnel shall at no time allow an employer-employee relationship to develop with VA organizations or their staff. VA organizations will refrain from any activities that create the appearance of such a relationship.

Contractors shall not perform inherently governmental functions including decision-making, supervision of Government employees, supervision of other contractors on other contracts, and activities that create the appearance of performing such functions.

7.1 REPORTING REQUIREMENTS

The Contractor shall provide the Contracting Officer’s Representative (COR) with Monthly Progress Reports in electronic form in Microsoft Word or Microsoft Excel. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding Month.

The Monthly Progress Reports shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The Contractor shall monitor performance against the previous month’s approved Monthly Progress Report and report any deviations. It is expected that the Contractor shall maintain communication with VA accordingly so that any arising issues are transparent to both parties to prevent escalation of outstanding issues. The Monthly Progress Reports shall document coordination between all of the interrelated Program Management Lean Six Sigma (PMLSS) Task Orders that support 2017 MyVA Initiatives.

Deliverable:

- Monthly Progress Reports

7.2 DEPLOY THE CDS CALCULATOR APPLICATION

8. DELIVERY SCHEDULE

Task Deliverable Quantity Delivery Date

7.1 (1) Deploy the CDS calculator application in the CDS Console

Contract Award plus 90 days

7.2 (2) Work with clinical stakeholder to identify further use cases of the tool

N/A Ongoing throughout period of performance

7.2 (3)

Capture usage metrics (statistics and analytics in dashboard) to understand utility to clinicians and share with VA

N/A Ongoing throughout period of performance

7.2 (4) Dedicated project and project management support throughout the period of performance

N/A Ongoing throughout period of performance

7.2 (5) Monthly updates

1x/month throughout period of performance

Ongoing throughout period of performance

9. KEY PERSONNEL

Skilled experienced professional and/or technical personnel are essential for successful contractor accomplishment of the work to be performed under this effort. These are defined as individuals crucial to the successful performance of the orders issued and the programs being supported by those orders and are those persons identified as key personnel in accordance with solicitation requirements. The Contractor agrees that the key personnel shall not be removed, diverted, or replaced from work without prior notification of the CO. Contractor staff shall be fully qualified and have the level of experience necessary to accomplish the requirements of this PWS, as well as those requirements outlined in Section 7.0. The following labor categories are required.

Labor Category Description Experience CDS calculator application developer

Deploy the CDS calculator application on the Production CDS Console for CVHCS. Assess usability and iterate on UI/UX based on VA feedback and design for seamless clinical workflow integration

Intermediate -advanced

Project Manager Manage project, communicate between Contractor and VHA, ensure timely completion of the project

Intermediate – advanced

Physician Informaticist

SME with clinical experience to guide implementation, training, and assessment of the application implementation.

Advanced

Substitution of Personnel: Any personnel the contractor offers as substitutes shall have the ability and qualifications, including educations and experience, equal to or better than the key personnel whose biography was submitted with the successful proposal. Requests to substitute personnel shall be provided to the CO for review and approval. All notification of substitutions in key personnel shall be submitted to the CO at least 15 calendar days prior to making and change in key personnel, to the maximum extent practicable. The notification shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete biography/resume for the proposed substitute, and any other information requested by the CO. The CO will evaluate such requests and promptly notify the contractor of approval or disapproval thereof in writing.

10. OTHER DIRECT COSTS

None

11. GOVERNMENT- FURNISHED EQUIPMENT/ MATERIALS/ FACILITIES/

INFORMATION

The Government will not provide physical workspace or equipment for this contract.

All VA policies related to networked computer use will apply. Personal identification verification (PIV) cards shall be required for all contractor personnel with VA network access/accounts.

Contractor personnel shall complete VA’s Privacy and Information Security Awareness and Rules of Behavior training before networked computer access will be granted.

Prior to the use of any Government-furnished equipment, the Contractor shall complete all mandatory training courses on the VA training site, currently the VA Talent Management System (TMS), and will be tracked therein. The TMS may be accessed at https://www.tms.va.gov. If an individual does not have a TMS profile, go to https://www.tms.va.gov and click on the “Create New User” link on the TMS to gain access.

12. QUALITY ASSURANCE SURVEILLANCE PLAN

Performance Standards define required performance for specific tasks. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Government may utilize the Performance Based Service Assessment Survey, provided as Attachment E, or other methods to compare contractor performance to the Acceptable Levels of Performance (ALPs).

12.1 METHODS OF SURVEILLANCE

Various methods exist to monitor performance. The COR shall use any or several of the surveillance methods listed below in the administration of this QASP.

1. 100% Inspection (evaluates all outcomes) - Each month, the COR shall review all of the contractor’s performance/generated documentation and document results accordingly.

This assessment shall be placed in the COR’s QA file.

2. Random Sample - The COR shall review a random sampling of the contractor’s performance/generated documentation and document your results accordingly. This assessment shall be placed in the COR’s QA file.

3. Validated Customer Complaint or Validated Below Average ALP in a Specific Area - Each month, the COR shall review the contractor’s performance/generated documentation corresponding to a validated customer complaint or validated inability to perform in accordance with the ALP in a specific area and document your results accordingly. This assessment shall be placed in the COR’s QA file.

12.2 FREQUENCY OF MEASUREMENT

During task order performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed, and at a minimum shall be twice a year.

12.3 ACCEPTABLE PERFORMANCE LEVELS (APLS)

Requirement Performance

Standard Surveillance

Method Outcome

PROJECT

MANAGEMENT,

MILESTONES, AND

SCHEDULE

a. Notifies customer of potential problems 90% of the time.

100% Inspection of agreed upon milestones per the approved PMP

Notification occurs within two business days of potential issue when known in advance or within 24 hours of urgent problems, where less than two business days exist

b. Submits Deliverables in accordance with the deliverable schedule within (+/-) five business days with

100% Inspection of deliverables

No more than five incidents of performance schedule slippage no more than five incidents of performance slippage

WRITTEN

COMMUNICATION

Uses correct English grammar, punctuation, and spelling 95% of the time;

communicates information in a succinct and organized manner, produces written information that is appropriate for the intended audience

Random Sampling Written communication is consistently error-free and clear and concise so that the message is easily understood by others

CUSTOMER

SUPPORT

Courteous and professional interactions to receive and fill task order deliverables and in providing order status. Customer (VA) support satisfaction, having no more than 5 incidents of dissatisfaction.

Customer Feedback and Complaints based on interactions with the contractor

Customer problems are resolved within the same business day; no more than 5 incidents spent by Government personnel in providing corrective feedback on unacceptable customer service/professionalism

12.4 DOCUMENTING PERFORMANCE

Acceptable Performance The Government shall document acceptable performance in accordance with the chart above.

Any report may become a part of the supporting documentation for any contractual action.

Unacceptable Performance When unacceptable performance occurs, the COR shall inform the CO. This will always be in writing although when circumstances necessitate immediate verbal communication, that communication will be followed in writing. The COR shall document the discussion and place it in the COR file.

When the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing to the CO. The CDR will state how long after receipt the contractor has to take corrective action. The CDR will also specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CO shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

13. SECURITY AND PRIVACY REQUIREMENTS

13.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Suitability and Security Program,” Appendix A)

Low / Tier 1 Tier 1 / National Agency Check with Written Inquiries (NACI) A Tier 1/NACI is conducted by OPM and covers a 5-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), Federal Bureau of Investigation (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment.

In VA it is used for Non-sensitive or Low Risk positions.

Moderate / Tier 2

Tier 2 / Moderate Background Investigation (MBI) A Tier 2/MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check], a credit report covering a period of 5 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law enforcement check; and a verification of the educational degree.

High / Tier 4 Tier 4 / Background Investigation (BI) A Tier 4/BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment;

an interview with the subject, spouse, neighbors, supervisor, co-workers;

court records, law enforcement check, and a verification of the educational degree.

The position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the Performance Work Statement are:

Position Sensitivity and Background Investigation Requirements by Task Task Number Tier1 / Low / NACI Tier 2 / Moderate /

MBI

Tier 4 / High / BI

INSERT TASK #

The Tasks identified above, and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

13.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

13.2.1 Contractor Responsibilities:

A. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation, and are able to read, write, speak and understand the English language.

B. The Contractor shall bear the expense of obtaining background investigations. Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations in accordance with the ProPath template. The Contractor Staff Roster shall contain the Contractor’s Full Name, Date of Birth, Place of Birth, individual background investigation level requirement (based upon Section 7.0 Tasks), etc. The Contractor shall submit full Social Security Numbers either within the Contractor Staff Roster or under separate cover to the COR. The Contractor Staff Roster shall be updated and provided to VA within 1 day of any changes in employee status, training certification completion status, Background Investigation level status, additions/removal of employees, etc. throughout the Period of Performance. The Contractor Staff Roster shall remain a historical document indicating all past information and the Contractor shall indicate in the Comment field, employees no longer supporting this contract. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service.

C. The Contractor should coordinate the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized.

D. The Contractor shall ensure the following required forms are submitted to the COR within 5 days after contract award:

1) For a Tier 1/Low Risk designation:

a) OF-306

b) DVA Memorandum – Electronic Fingerprints

2) For Tier 2/Moderate or Tier 4/High Risk designation:

a) OF-306

b) VA Form 0710

c) DVA Memorandum – Electronic Fingerprints

The Contractor personnel shall submit all required information related to their background investigations (completion of the investigation documents (SF85, SF85P, or SF 86) utilizing the Office of Personnel Management’s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP) after receiving an email notification from the Security and Investigation Center (SIC).

The Contractor employee shall certify and release the e-QIP document, print and sign the signature pages, and send them encrypted to the COR for electronic submission to the SIC.

These documents shall be submitted to the COR within 3 business days of receipt of the e- QIP notification email. (Note: OPM is moving towards a “click to sign” process. If click to sign is used, the Contractor employee should notify the COR within 3 business days that documents were signed via eQIP).

E. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

F. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC) or “Closed, No Issues” (SAC) finger print results, training delineated in VA Handbook 6500.6 (Appendix C, Section 9), and, the signed “Contractor Rules of Behavior.” However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of the Office of Personnel Management (OPM).

G. The Contractor, when notified of an unfavorably adjudicated background investigation on a

Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

Failure to comply with the Contractor personnel security investigative requirements may result in loss of physical and/or logical access to VA facilities and systems by Contractor and Subcontractor employees and/or termination of the contract for default.

Identity Credential Holders must follow all HSPD-12 policies and procedures as well as use and protect their assigned identity credentials in accordance with VA policies and procedures, displaying their badges at all times, and returning the identity credentials upon termination of their relationship with VA.

Contractor employees shall complete a VA Systems Access Agreement if they are provided access privileges as an authorized user of the computer system of VA.

13.2.3 Physical Security and Safety Requirements

The Contractor and their personnel shall follow all VA policies, standard operating procedures, applicable laws and regulations while on VA property. Violations of VA regulations and policies may result in citation and disciplinary measures for persons violating the law.

a. The Contractor and their personnel shall wear visible identification at all times while they are on the premises.

b. VA does not provide parking spaces at the work site; the Contractor must obtain parking at the work site if needed. It is the responsibility of the Contractor to park in the appropriate designated parking areas. VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

c. Smoking is prohibited inside/outside any building other than the designated smoking areas.

d. Possession of weapons is prohibited.

e. The Contractor shall obtain all necessary licenses and/or permits required to perform the work, with the exception of software licenses that need to be procured from a Contractor or vendor in accordance with the requirements document. The Contractor shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

13.2.4 Confidentiality and Non-Disclosure

a. The Contractor shall follow all VA rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations.

b. The VA CO will be the sole authorized official to release in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this contract. The Contractor shall release no information. Any request for information relating to this contract presented to the Contractor shall be submitted to the VA CO for response.

c. Contractor personnel recognize that in the performance of this effort, Contractor personnel may receive or have access to sensitive information, including information provided on a proprietary basis by carriers, equipment manufacturers and other private or public entities.

Contractor personnel agree to safeguard such information and use the information exclusively in the performance of this contract. Contractor shall follow all VA rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations as enumerated in this section and elsewhere in this Contract and its subparts and appendices.

d. Contractor shall limit access to the minimum number of personnel necessary for contract performance for all information considered sensitive or proprietary in nature. If the Contractor is uncertain of the sensitivity of any information obtained during the performance this contract, the Contractor has a responsibility to ask the VA CO.

e. Contractor shall train all of their employees involved in the performance of this contract on their roles and responsibilities for proper handling and nondisclosure of sensitive VA or proprietary information. Contractor personnel shall not engage in any other action, venture or employment wherein sensitive information shall be used for the profit of any party other than those furnishing the information. The sensitive information transferred, generated, transmitted, or stored herein is for VA benefit and ownership alone.

f. Contractor shall maintain physical security at all facilities housing the activities performed under this contract, including any Contractor facilities according to VA-approved guidelines and directives. The Contractor shall ensure that security procedures are defined and enforced to ensure all personnel who are provided access to patient data must comply with published procedures to protect the privacy and confidentiality of such information as required by VA.

g. Contractor must adhere to the following:

1) The use of “thumb drives” or any other medium for transport of information is expressly prohibited.

2) Controlled access to system and security software and documentation.

3) Recording, monitoring, and control of passwords and privileges.

4) All terminated personnel are denied physical and electronic access to all data, program listings, data processing equipment and systems.

5) VA, as well as any Contractor (or Subcontractor) systems used to support development, provide the capability to cancel immediately all access privileges and authorizations upon employee termination.

6) Contractor PM and VA PM are informed within twenty-four (24) hours of any employee termination.

7) Acquisition sensitive information shall be marked "Acquisition Sensitive" and shall be handled as "For Official Use Only (FOUO)".

8) Contractor does not require access to classified data.

h. Regulatory standard of conduct governs all personnel directly and indirectly involved in procurements. All personnel engaged in procurement and related activities shall conduct business in a manner above reproach and, except as authorized by statute or regulation, with complete impartiality and with preferential treatment for none. The general rule is to strictly avoid any conflict of interest or even the appearance of a conflict of interest in VA/Contractor relationships.

i. VA Form 0752, Confidentiality of Sensitive Information Non-Disclosure Agreement, shall be completed by all Contractor employees that receive Government furnished laptops, and shall be provided to the CO before any work is performed. In the case that Contractor personnel are replaced in the future, their replacements shall complete VA Form 0752 prior to beginning work.

13.3 APPLICABLE VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE (per VA HANDBOOK 6500.6, APPENDIX C, MARCH 12, 2010)

13.3.1 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.

13.3.2 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A Contractor/Subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, Subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All Contractors, Subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for Contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates (e.g. Business Associate Agreement, Section 3G), 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 CO 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 CO must also be notified immediately by the Contractor or Subcontractor prior to an unfriendly termination.

13.3.3 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 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 information is returned to VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of Contractor and Subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, Contractor/Subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this contract without prior written approval by 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 CO 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 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. 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.

h. The Contractor/Subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA minimum requirements. VA Configuration Guidelines are available upon request.

i. 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 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 CO for response.

j. 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 CO for response.

k. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or a Memorandum of Understanding-Interconnection Service Agreement (MOU-ISA) for system interconnection, the Contractor/Subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

13.3.4 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 COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the Contractor/Subcontractor has access.

b. To the extent known by the Contractor/Subcontractor, the Contractor/Subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the Contractor/Subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the Contractor/Subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its Subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The Contractor/Subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

13.3.5 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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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 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 3relevant 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.

13.3.6 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) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior…