36C24120Q0264-0001001.pdf

Performance Work Statement (PWS)

Cloud-Based Molecular Diagnostics

Reporting Tool

This is for the implementation of a Cloud-Based Molecular Diagnostic Reporting Tool portal to generate reports from the Agena MassArray System. This PWS will work in conjunction in indicating the contractor’s performance of the contract, and how they will be evaluated.

1 Introduction Pharmacogenetic report generation software service to translate raw genomic data generated by

West Haven Agena MassArray PGx patient testing. The Agena MassArray is the analyzer currently being used to perform genetic testing at the West Haven Molecular Diagnostic Lab, the reference lab for VISN 1 Labs.

1.1 Mission

VISN 1 Pathology and Laboratory Medicine Service (P&LMS) on behalf of the Molecular

Diagnostics Laboratory at West Haven VA requires acquisition of a Laboratory Report Generation service based on genomic data generated by the Agena MassArray PGx testing.

1.2 Background

The purpose of this action is to establish a VISN contract with for report generation software service, which will translate raw genomic data generated by Agena MassArray PGx testing into a custom pharmacogenetic report for each patient tested. This agreement is for a firm fixed contract price setup and implementation, and for custom report generation for a five (5) year period.

1.3 Scope

This agreement would ensure availability, ease of procurement, and fixed pricing for this testing and ensure a continuance of this service to all veterans within VISN 1, VA New England Healthcare System. This procurement is for Pharmacogenetic Report generation cloud-based software to convert raw genomic data generated by the Agena MassArray analyzer owned by VA Connecticut (VACT), West Haven Campus, P&LMS, Molecular Diagnostics Department, into individualized patient reports. The Agena MassArray analyzer is currently performing this testing in the VACT clinical laboratory located at the following VISN 1 facility: VA Connecticut Healthcare System, West Haven Campus, 950 Campbell Avenue, West Haven, CT 06516.

2 General Requirements The Contractor is required to provide:

1. Consultation on genes/SNP panel to ensure accuracy of testing results

2. Creation of a standard report format

3. Minimal number of reports to be generated per month (50)

4. Creation of portal to download data and upload completed reports.

5. Training with the software solution to designated laboratory personnel

6. End to end workflow tests that allow for the evaluation and accuracy of reports

7. Comply with the Federal Information Security Management Act (FISMA).

8. Comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

9. Comply with all VA Cloud-specific security and privacy requirements.

10. The contractor will provide direct delivery to the West Haven VA Lab FOB Destination.

West Haven VA Lab will order using established procedures and referencing the purchase agreement and will be invoiced for their own orders. No shipping charges- FOB destination.

11. The contractor will provide a quarterly report to the Contracting Officer’s Representative (COR) that indicates the volume of PGx Reports Generated by the VISN 1 site.

VISN 1 site included in this agreement:

VA Connecticut Healthcare System, West Haven Campus, 950 Campbell Ave., West Haven, CT 06516, VA Molecular Diagnostics Laboratory

POCs/or CORs: TBD upon contract award

2.1 Non-Personal Services

The Government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Procuring Contracting Officer (PCO) immediately.

2.2 Business Relations

The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

2.3 Contract Administration and Management

The following subsections specify requirements for contract, management, and personnel administration.

2.3.1 Contract Management

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations at [insert location] and the contractor's corporate offices.

2.3.2 Contract Administration

The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single point of contact between the Government and Contractor personnel assigned to support contracts or task orders. The contractor shall assign work effort and maintaining proper and accurate time keeping records of personnel assigned to work on the requirement.

2.3.3 Personnel Administration

The contractor shall provide the following management and support as required. The contractor shall provide for employees during designated Government non-workdays or other periods where Government offices are closed due to weather or security conditions. The contractor shall maintain the currency of their employees by providing initial and refresher training as required to meet the PWS requirements. The contractor shall provide necessary infrastructure to support contract pursuant to the tasks for the operation and the generating of reports as needed.

2.4 Subcontract Management

The contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime contractor will manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. Contractors may add subcontractors to their team after notification to the Procuring Contracting Officer (PCO) or

Contracting Officer Representative (COR). Cross teaming may or may not be permitted.

2.5 Contractor Personnel, Disciplines, and Specialties

The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall match personnel skills to the work or task with a minimum of under/over employment of resources. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

2.6 Location and Hours of Work

Accomplishment of the results contained in this PWS requires work at VA Connecticut

Healthcare System, 950 Campbell Avenue, West Haven CT 06516. Normal workdays are

Monday through Friday except US Federal Holidays. Workers typically work eight (8) hours per day, 40 hours per week. However, the Hospital is operational 24 hours, 7 days per week.

for specific departments Flextime workers start not earlier than 0600 and not later than 0900.

Core hours of work are from 0900 to 1500 daily. All employees are expected to be available during core hours. Work at a Government site shall not take place on Federal holidays or weekends unless directed by the CO. The Contractor may also be required to support 24/7 operations 365 days per year as identified in individual orders. There are ten (10) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, four are set by date:

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

If any of the above falls on a Saturday, then Friday shall be observed as a holiday.

Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February

Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

2.7 Travel

The Government anticipates no travel to perform the tasks associated with the effort.

3 Performance Requirements

Provide monthly reports in accordance to the information generated through the portal from the Agena MassArray System. Reports must provide accurate information pursuant to the patient’s care. Contractor will provide training to all designated VA Personnel that are required to receive, and or interpret the data. All information received and submitted will be protected by the contractor, any breaches will be reported within 24 hours to the Service, Designated VA

Point of Contact, and VA Contracting Office.

Number of reports per month are indicated in Price/Cost Schedule

3.1 Provide Monthly Reports

3.1.1 Generate accurate reports through the Cloud-Base Portal

Provide the number of reports specified in the contract

Performance Standards

All reports will be in accordance to the standards in the deliverables (#5). There will be less than 1 minor inaccuracy for a report. Reports will be submitted timely, and on a monthly basis. There will less than 1 occurrence per month, and less than 3 per year

3.1.2 Contractor will provide training, and updates of any software in accordance to the generating the reports

Contractor will provide training to all designated VA personnel that are vital to the generation, and interpretation of the reports. Contractor will ensure that software updates are know by the VA Staff, and any other personnel relevant to the contract. Contractor will coordinate with COR and Service Point of Contact for any personnel changes and provide training within 2 weeks of the service notification in writing (via e-mail/or phone call). There will be only 1 occurrence per month, and less than 5 per year.

3.1.3 Information received and sent through the Cloud-Based Portal will be protected and safeguarded in accordance to Federal Guidelines for Privacy and Information Security.

Meet all Federal, VHA, State Guidelines for protecting patient information

There will be less than 0 breach per year, and less than 1 in a 5-year period. Contractor will notify the VA within 24 hours of the breach and have a plan in place to resolve the problem. In addition, the contractor will notify all relevant

3.2 Invoicing

All invoicing will be completed on a monthly basis

3.2.1 The contractor will invoice monthly and itemize all charges for the invoice.

Any additional charges must be approved prior to submitted invoice (Travel, etc.)

All invoices will be submitted monthly, and on time. There will be 1 inaccurate invoice per quarter, and less than 4 per year

4 Special Requirements

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

4.1 Security and Safety

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.

The Agreement will outline responsibilities in the following areas: Contractor security supervision; Standard Practice Procedures; access, accountability, storage, and transmission of classified material; marking requirements; security education; personnel security clearances;

reports; security checks; security guidance; emergency protection; protection of government resources; periodic security reviews; and other responsibilities, as required.

4.2 Transition

The contractor shall follow the transition plan submitted as part of the proposal and keep the

Government fully informed of status throughout the transition period. Throughout the phase-in/phase-out periods, it is essential that attention be given to minimize interruptions or delays to work in progress that would impact the mission. The contractor must plan for the transfer of work control, delineating the method for processing and assigning tasks during the phase-in/phase-out periods through their coordination with all applicable Federal Agencies, VA

Connecticut Healthcare System point of contacts.

4.3 Government Furnished Materials

The Government will make available the materials, communications capability and information generated from the Agena MassArray System as identified in the contract for use by the contractor in the performance of this contract.

4.4 Applicable Directives

The Federal CIO has confirmed that for SaaS, agencies have the option of: (1) leveraging a P- ATO completed by the Joint Authorization Board; (2) leveraging an ATO completed by another agency, or (3) conducting their own ATO. However, if either the JAB or another agency has already gone through the RMF process with the cloud service provider then we encourage the agency to leverage the work already done. This is less burdensome for both the agencies and the service providers.

Regardless of the approach, VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

1. The information system solution selected by the Contractor shall comply with the Federal

Information Security Management Act (FISMA).

2. The Contractor shall comply with FedRAMP requirements as mandated by Federal laws and policies, including making available any documentation, physical access, and logical access needed to support this requirement.

3. Following guidance from the Federal CIO, VA will utilize existing JAB ATO or agency ATO issued by another agency as a starting point for FedRAMP requirements. If neither of those exist, VA will sponsor FedRAMP ATO. VA will be using the FedRAMP baselines as a starting point, since they are specifically tailored for cloud services.

4. The Contractor shall, where applicable, assist with the VA Authority to Operate (ATO)

Process to help achieve agency authorization of the cloud service or migrated application.

5. The Contractor shall afford VA access to the Contractor’s and Cloud Service Provider’s facilities, installations, technical capabilities, operations, documentation, records, and databases.

6. If new or unanticipated threats or hazards are discovered by either VA or the Contractor, or if existing safeguards have ceased to function, the discoverer shall immediately bring the situation to the attention of the other party in accordance with the security appendix B.

7. The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the COR/CO.

Other considerations:

1. Trusted Internet Connection (TIC) – Include TIC requirements for SaaS that interfaces with VA systems, SaaS must meet all VA Security requirements for non-SaaS.

2. Include Addendum A – Additional VA Requirements, Consolidated

3. Include Addendum B – VA Information and Information System Security/Privacy Language

The above language can be found at Technology Acquisition Center’s Virtual Office of

Acquisition here.

5 Deliverables

Deliverables will include reports that include the following minimal patient data.

• Specimen Details

• Risk Management Information

• Potentially Impacted Medications

• Dosage Guidance

• Test Details

6 Related Documents

The following Documents are related to this project

• Trusted Internet Connection (TIC): Include TIC requirements for SaaS that interfaces with https://www.fedramp.gov/agency-authorization/ http://voa.aac.dva.va.gov/sites/SIP/Customer%20Portal%20Templates/Forms/AllItems.aspx?RootFolder=%2Fsites%2FSIP%2FCustomer%20Portal%20Templates%2FOAO%20Acquisition%20Requirements%20Package%20%28ARP%29%20Templates%2FOther%20Templates%20%28Standard%20Templates%29&FolderCTID=0x01200079368963D4577048840AF10BBF4043D6&View=%7b8FF06DE8-29A5-4123-B6C8-F7048D21A0B4%7d

VA systems, must meet all VA Security requirements for non-SaaS.

• Include Addendum A – Additional VA Requirements, Consolidated

• Include Addendum B – VA Information and Information System Security/Privacy Language