12-233-SOL-00090.pdf

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12-233-SOL-00090

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1 Modeling and Simulation Tool Project

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54 2 of

Solicitation #: 12-233-SOL-00090 Health Data Modeling and Simulation Software as a Service

SECTION B – PRODUCTS OR SERVICES AND PRICES/COSTS

B.1. CONSIDERATION AND PAYMENT

The Contractor shall provide the services described in Section C, Description/ Specifications/Work Statement. Except as otherwise specified in the contract, the Contractor shall furnish the necessary personnel, materials, services, facilities, and otherwise do all things necessary for or incident to the performance of the work set forth herein.

In consideration of satisfactory performance of the work described in the Statement of Work, the Contractor shall be compensated for the successful completion of the tasks set forth below successfully providing the services as set forth below. The Government shall not be obligated to pay any amount in excess of the ceiling price.

B.2. CONTRACT PRICING

This is an IDIQ contract with Firm Fixed price, Time and Materials and Labor Hour task orders. In consideration for the successful performance of this work, the Contractor shall be compensated for the completion of the following items as specified in the Task Orders:

B.2.1. Time-and-Material Task Orders For time-and-material call orders, the Contractor shall identify all applicable costs for direct labor (i.e., labor categories, fixed-loaded hourly rates) and materials (direct materials, other direct cost, and indirect cost items) upon which the proposed cost is based. The Contractor shall submit sufficient documentation to support proposed cost.

The contractor shall be reimbursed for actual labor hours at the agreed fixed-loaded hourly rates and actual costs for materials, directly incurred for performance of the task order.

B.2.2. Labor-Hour Task Orders For labor-hour task orders, the Contractor shall detail the Contractor’s fixed-loaded hourly rates and specified labor categories. The Contractor shall be reimbursed for the number of actual hours incurred in performance of the work specified.

B.2.3. Firm-Fixed-Price (FFP) Task Orders For FFP task orders, the Contractor shall identify all applicable costs upon which the proposed price is based. The Contractor shall submit sufficient documentation to support the price proposed.

The Government will pay the Contractor, upon submission of a proper invoice, the prices stipulated in the task order for service rendered and accepted.

Base Period Product/Service Number of Users Total Price

Option Year 1

Option Year 2

Option Year 3

B.3. TASK ORDER

In order to establish a contract type and price for each task order, a Task Order Request for Proposal (TORFP) will be provided to the contractor in accordance with the process described in Section G herein. The Government expects the contractor to use the established unit prices or a discounted price for each functional area set forth in the IDIQ contract when pricing proposals. The Government reserves the right to conduct discussions with the contractor of any price proposal received in response to a TORFP.

The Contractor shall perform work under this contract only as directed in task orders issued by the contracting officer. The task orders may be negotiated on a Firm Fixed Price (FFP), Time and Materials or Labor Hour basis.

B.4. MINIMUM CONTRACT GUARANTEE

The minimum order guarantee under the resultant individual tasks will be $25,000.00 for the entire life of the IDIQ contract. The Government has no obligation to issue task orders (TO) to the contractor beyond this amount. Once the minimum has been met, the contractor will continue to have the opportunity to be issued TOs in accordance with the contract. The funding for each TO shall be contained in the individual TO, and will not be provided at the time of contract award.

B.5. MAXIMUM CONTRACT QUANTITY

This is a single award Indefinite Delivery, Indefinite Quantity contract with an overall contract value of $5,000,000.00.

SECTION C – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

C.1. TITLE

Health Data Modeling and Simulation Software as a Service

C.2. PURPOSE

The purpose of this contract is to acquire a Software-as- a- Service (SaaS) platform system that supports data modeling and simulation activities involving health and health care. In addition, the contract will support acquisition of materials, training and education in the use of the technology. Finally, additional capabilities are needed to support consultations and adaptations of the platform system to meet specialized needs. This platform system will be used to support research, analysis, and evaluation in a wide variety of applications across the Department of Health and Human Services

(HHS).

This acquisition is structured to enable HHS staff needing access to the modeling and simulation platform system to subscribe on an annual basis through a common acquisition platform. Accompanying the access to the platform system, the user will also be provided at no additional cost educational and training services to enable effective use of the modeling and simulation modules and services. In addition, at additional costs, customized modules and data constructs within the modeling and simulation system can be requested through this contract.

C.3. BACKGROUND

Across the operating and staff divisions of HHS, there is a growing need for analytic tools that can be used to conduct analyses of various types to aid in research, policy analysis, and evaluation. There is a need for HHS to have access to an existing modeling and simulation system that can be used to evaluate variables related to disease conditions, health care settings, medical product interventions, and many other considerations. These capabilities are to be provided as currently existing software services, In addition, these modeling and simulation features need to accommodate a high number of variables, be rapidly available and incorporate a large number (more than 20) users accessing the platform simultaneously.

The use of modeling and simulation software will enable improved capability and reliability of the results from research and analysis efforts. The insights gained from the use of the modeling and simulation may be used in policy formulation, design of research projects, support new hypothesis generation, promote construction of new analytic frameworks, inform survey design and methodology, and other applications.

Table 1 Types of Modeling and Simulation Activities to be Supported

• Provides information on a wide range of diseases and conditions

• Integrates patient and health care provider behaviors

• Supports analysis on healthcare delivery systems

• Enables customization of interventions, tests, and treatments

• Provides capabilities to modify, stratify, and adapt model populations to align with specific patient populations

• Integrates multiple disease variables and conditions into a single model to evaluate clinical scenarios involving co-morbidities, multiple interventions, and multiple treatment effects.

In the past year, provisions of the HiTECH Act and the Patient Protection and Affordable Care Act have new requirements for the use of data in design of health benefits;

comparison of quality, cost, and outcomes; evaluation of population health outcomes in the context of health care delivery system design; and many more. It is anticipated that use of modeling and simulation platforms will be in high demand for policy makers and researchers, and ultimately, health care providers, to develop better situational awareness, and relevance of their own information to modeled populations.

The interface of HHS users and the platform system is envisioned to enable online access for up to 50 HHS users to access the modeling and simulation tools provided as a platform system. This will allow all users to input data, queries, and customize views and conditions for their research and analyses. Depicted below is a schematic representation of a typical workflow using the system.

C.4 SPECIFICATION OF GENERAL REQUIREMENTS

1. Platform system shall be a software interface that makes a subset of the capabilities of Software as a Service (SaaS) readily available over the worldwide web.

2. Platform system shall be available for use and support minimum requirements at the time of contract initiation.

3. Platform system shall be able to support simultaneous access and use by up to 50 independent users.

4. Contractor will provide annual subscription process for each user.

5. User will provide up to 1000 hours of consulting for design and computer programming for subtask requirements requested by users (at additional cost).

6. Platform system shall have the following capabilities: forecasting, cost and cost-effectiveness analysis, comparative effectiveness analysis, priority setting, clinical trial design and prediction, analysis of performance improvement and incentives, guideline design, drug portfolio selection, and the translation of efficacy (for example, clinical trial results) into effectiveness (results that can be expected in real settings).

7. The tool shall have a “Search Strategy” that shall be able to identify publications used to build the disease models. Based on a pre-set inclusion criteria individual terms shall be combined for the search. After the search is performed, each abstract found is reviewed to determine if it meets the inclusion criteria.

Abstracts that meet the inclusion criteria are evaluated for use in building the model.

8. The vendor shall provide on-line education resources, webinar-based training sessions for new users, and make available access for email and web communication features for questions and comments.

9. There shall be a user guide (electronic) provided to each user that provides details of the data modeling system, instructions for installation or log-on, demonstration examples, and other pertinent information for basic level users.

10. The vendor shall provide information about security and confidentiality policies regarding interfaces with user provided data that interacts with the platform.

11. The vendor shall also provide descriptions of capabilities for collaborating or offering consulting services related to the platform for custom modifications of algorithms, displays, or data inputs into the model for research applications.

Additional considerations toward interests by the vendor to engage in collaborations using other modeling platforms should also be included.

C.5 SPECIFICATION OF DATA REQUIREMENTS

1. Platform system shall have a strategy for handling data/studies that show different or conflicting results.

2. Simulate legitimate data that are used to construct an initial set of simulated individuals whose characteristics such as demographic information, biomarkers, past medical history, and behaviors typically match those of the actual individuals. This method captures correlations among biomarkers and other variables that exist in reality.

3. The platform system shall be able to accept data in different formats (from data sources) and convert that data into the appropriate distribution for instant input into the simulation tool.

4. The simulations shall be able to determine sensitivity to unknowns. A detailed simulation model should help identify the most important missing data

5. The models within the platform system should be capable of including many of the physiological variables that clinicians consider important in their own decisions. If a variable is used to assess a person’s risk of having or getting a condition, or is measured by standard clinical methods (e.g. tests, histories, physical examinations), or is used to diagnose or monitor the progress of a disease, or affects the length or quality of a patient’s life (e.g. symptoms, health outcomes), the model should be capable of calculating it. The model should represent those variables and their relationships as realistically as possible given current medical science and data. This includes maintaining the continuous nature of variables that are continuous in reality (including time), and representing the dependencies and causal relationships between variables, not just statistical associations.

6. Diseases should be defined in terms of their underlying physiological variables, as occurs in reality. This is necessary for accurately addressing different definitions of disease, and changes in definitions. The model should include the results of tests and the effects of prevention activities and treatments should be calculated through the pertinent physiological variables.

7. The model s should include the elements of a delivery system that administrators consider important, such as patient interactions with the system, care processes and protocols, utilization (e.g. procedures, visits, and admissions of various types), and costs. If a variable is specified in reports used to administer delivery systems, or is used by administrators or managers to monitor or forecast delivery systems, or is specified in national surveys such as the Ambulatory Care Survey or Hospital Discharge Survey, or is specified in claims for payment (e.g. CPT, ICD, DRG), the model should be able to calculate it.

8. The model s should be able to include all the conditions pertinent to questions of interest, in a single integrated model. This is required to accurately address co-morbidities, syndromes that affect multiple systems, use of multiple drugs, and drugs with multiple effects. It is also necessary for making comparisons between interventions or setting priorities across interventions that span multiple conditions such as obesity, diabetes, and dyslipidemia.

9. The model should include both patient and physician behaviors. Patient behaviors are required to accurately represent the effects of different behaviors in undertaking prevention activities such as smoking cessation or screening, seeking care for symptoms, adhering to treatment recommendations, and responding to incentives such as co-payment reductions. Physician behaviors are required to accurately represent different levels of performance against guidelines, variations in practice patterns from national norms, and the effects of incentive programs such as pay for performance.

10. The model should have detailed documentation describing the structure of the model, its validation and its application to specific analyses. Specifically, the modelers involved in creation of the model should demonstrate a consistent and reproducible approach to model performance testing and documentation.

11. Each module’s interface should be intuitive for trained analysts to use without having to learn any specialized programming language. The structure of the interfaces should be appropriate for collaborative analyses between analysts and should accommodate various routine visualization and data exploration methods such as the creation of tables and the creation of charts.

12. The interfaces should be supported by a professional software development and quality assurance team and users of the interfaces should have access to training and support that addresses the use and functionality of the interfaces as well as scientific support regarding the function of the model.

C.6 USER INTERFACE REQUIREMENTS

1. The tool shall have a user friendly interface for the users to run their own healthcare simulations using a comprehensive web interface with intuitive editors for setting up multi-scenario studies, specifying:

• Populations

• Background care

• Conditions

• Standard or custom interventions

• Treatments

2. The intended users of the product presumably will have basic domain knowledge of healthcare operations. The tool interface shall focus on being intuitive to the user by providing proper messages wherever required.

3. The tool interface shall be user friendly for the users to be able to setup complex scenarios and run simulations faster by providing input in a more accurate, easy and efficient manner.

C.6.1 Hardware requirements

1. The tool shall be compatible with Windows/Linux/Mac Operating systems.

2. The tool shall be able to be run with Internet Explorer 7.0 and higher and Mozilla

Firefox 3.0 and higher.

3. The tool should be capable of being operated via broadband connection to the internet.

C.6.2 Performance requirements

1. The tool shall be able to handle multiple simulations without impacting other simulations or users.

2. The tool shall be able to function seamlessly during a transition/upgrade period with existing/current tools that support the simulation.

3. The tool shall have low overhead/impact on the existing system.

C.6.3 Communication requirements

1. The tool shall use standardized communication between different parts of the software.

C.7 OPERATIONS REQUIREMENTS

1. The various modes of operation of this tool would be:

• Running simulations for a specific interventions, costs of interventions, performance to guideline and population inclusion/exclusion criteria.

• Running the simulation in batch mode given a set of specific Interventions, costs of Interventions, performance to guideline and population Inclusion/exclusion criteria

2. The platform system shall run the simulation process to complete without requiring additional user action.

C.8 SAAS REQUIREMENTS

1. On-Demand Self Service: The capability for Service ordering activity shall be provided without vendor review or approval once the initial order has been submitted

2. Network Access: The Internet access to the SaaS shall be provided by the Vendor.

3. Location independent Resource pooling: Resources needed to deliver the SaaS shall be provisioned by the Vendor independently from the physical location of the facilities.

4. Measured Service: Visibility into Service usage (data analytics) shall be provided by the Vendor using electronic means.

5. Demonstrate Capabilities: The Vendor shall provide test login credentials to demonstrate SaaS capabilities of the tool.

C.9 SPECIFICATIONS OF TASKS

The contractor shall provide all necessary system platform access, materials, personnel (which should include, but not be limited to, personal computing, networking, training, education, and other communication resources), services, and otherwise provide for all of the tasks listed below. The work under this contract is classified into three broad areas:

1. Providing on-line access to health data modeling and simulation software as a service platform system

2. User training and education to include on-call assistance and documentation related to HHS use of the platform system

3. Consultation and customization of the platform systems modules to accommodate user provided modules and data sets

The work performed to meet these three areas are summarized in the following tasks.

C.9.1 Task 1 – Access To Health Data Modeling And Simulation Software

Provide Access to health data modeling and simulation software.

The contractor shall be responsible for providing to registered users subscription access to platform system capabilities as described in the requirements. The subscription access shall be for a twelve month period starting from the contract award date. The contractor shall provide users with notification of system activation, user interface option requirements, training and education modules, documentation of the system variables, on-line help desk information, and other pertinent information regarding use of the platform system. Contractor shall provide information to users on notification methods and approaches used to inform users of program upgrades and modifications to the modeling and simulation platforms.

C.9.2 Task 2 – Training and Education

User training and education to include on-call assistance and documentation related to HHS use of the platform system.

The contractor shall be responsible for providing all needed training and education need to perform basic operations for the system platform. The contractor shall include web-based on-line technical resources, webinars and conference call capabilities for new users, on-line submission of questions and answers with a 48 hour acknowledgement and response time capability. The contractor shall provide, if requested, in person seminar and user training with the location to be determined at the users’ discretion.

The contractor shall be responsible for maintaining a registry and log of the user education and training of all HHS users.

The contractor shall provide notice to all users of training sessions and educational programs, particularly those aimed at introducing new presentation tools, databases, and changes to the user interface.

The contractor shall view training as an ongoing task and is required at 6-month intervals to offer standard training exercises as new users acquire access to the platform system.

The contractor shall provide user and technical documentation for each module, the databases included in the platform system, publication records that document the uses of the platform system, technical design materials related to the architecture of the system, and a record of system modifications to any of the modules and base systems.

Planned changes to the operating system shall be provided to all users 30 days in advance of the modification, and an on-line (email) notification to users shall be sent when the changes have been made.

C.9.3 Task 3 – Consultation and Customization

Consultation and customization of the platform systems modules to accommodate user provided modules and data sets.

The Contractor shall provide the capability to provide design and computer programming to accommodate user needs for the following, but not limited to modification of algorithms, addition of user provided datasets, creation of new display sets, stratification parameters, and analytic tools. These modifications will use the system platform, and its existing modules.

The Contractor shall perform work for these customization projects at cost to the user through individual subtasks. The Contractor will have capabilities to test, modify, and provide user with the means to analyze and modify customized modules and tools. The Contractor will have capabilities to support up to 1000 hours of consulting per year.

C.9.4 Task 4 - Personnel

A. Project Manager

1. Has a comprehensive understanding of complex client SaaS modeling and simulation platform systems addressing both analytic and computing features

2. Ability to coordinate work orders and requests across a wide range of skills

3. Ability to perform multiple tasks simultaneously

4. Demonstrated in-depth knowledge of the algorithms, technical architecture, databases, and user interface design features

5. Demonstrated knowledge and experience with customer support for analytic and technical needs

6. Demonstrated knowledge and experience with design of customized module development for modeling and simulation B. Programmer

1. Demonstrated system and application knowledge and experience with design, troubleshooting, maintaining, and utilizing modeling and simulation platform systems as a SaaS model

2. Demonstrated capabilities and experience with hardware and software requirements defined in the scope of work

3. Demonstrated experience with designing algorithms, websites, and information systems to support SaaS modeling and simulation systems.

C. Analyst

1. Includes senior and junior analysts with background, education

(public policy; health, science, and medical policy; mathematics, statistics, and programming) appropriate for the performance of the analytic tasks required to estimate outcomes and impact of modeling and simulation scenarios

2. Demonstrated ability to manage large tasks using complex data sets for modeling and simulation in a SaaS environment

3. Detained knowledge of the databases used in the platform systems

4. Demonstrated experience with design, programming and operation of complex SaaS modeling and simulation systems platforms.

5. Ability to use modeling and simulation systems

6. Ability to use programming and analytical languages in conducting analysis using SaaS platform systems

C.10. PERFORMANCE BASED STANDARDS

Performance Measures The objectives set out below will have the following performance standards and expectations. Specific metrics will be provided in each task order.

FAILURE TO MEET THESE EXPECTATIONS WILL RESULT IN THE SERVICE

PROVIDER CORRECTING DEFIECIENCIES AT NO ADDITIONAL COST TO THE

AGENCY

Required

Services/Tasks Performance Standards Method of

Surveillance Standard to be Met/Allowable

Deviation Customer Satisfaction

Contractor adheres to requirements provided by

COTR

COTR feedback Products and Services produced within established timelines and meet requirements

Communication Contractor maintains frequent, and responsive communication with COTR (and documents them accordingly)

COTR feedback Products produced within established timelines and meet COTR requirements

Overall Management

Contractor maintains high level of quality assurance, responsiveness to COTR and Contracts Officer, reliability, completeness of tasks, contacts the COTR immediately with any issues or problems, meets time frames in the delivery schedule

COTR and Contracting Officer monitoring;

deliverables

COTR makes no more than 3 valid complaints in the base year and in each option year.

Deliverables arrive on time within agreed upon timelines.

Written Products High quality written materials are provided

COTR monitoring, reviews by COTR and technical representatives) and comments on products.

Successful review by COTR and/or technical representatives

SECTION D – PACKING AND PACKAGING [Reserved]

SECTION E – INSPECTION AND ACCEPTANCE

E.1. INSPECTION AND ACCEPTANCE

All work under this contract is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the government.

The Contracting Officer’s Technical Representative (COTR) is a duly authorized representative of the government and is responsible for inspection and acceptance of all items to be delivered under this contract.

E.2. ACCEPTANCE CRITERIA

Unless otherwise specified by the COTR, the general quality measures, as set forth below, will be applied to each work product received from the Contractor under this task order.

a. Accuracy: Work products shall be accurate in presentation, technical content, and adherence to accepted elements of style.

b. Clarity: Work Products shall be clear and concise. Any/All diagrams shall be easy to understand and be relevant to the supporting narrative.

c. Consistency to Requirements: All work products must satisfy the requirements of this Statement of Work.

d. Timeliness: Work products shall be submitted by the due date specified in this statement of work, unless or submitted in accordance with a later scheduled date determined by the Government.

e. File Editing: All text and diagrammatic files shall be editable by the Government.

f. Format: Work products shall be submitted as specified in each Task Order.

E.3. APPROVALS BY THE COTR

All services delivered to the COTR will be deemed to have been accepted 30 calendar days after date of delivery, except as otherwise specified in this contract, if written approval or disapproval has not been given within such period.

SECTION F – DELIVERIES OR PERFORMANCE

F.1. PLACE OF PERFORMANCE:

The work is to be performed at the contractor’s facility and the subscription /services provided shall all be accessible on-line.

F.2. PERIOD OF PERFORMANCE

The period of performance is a base period of 1 year, with three (3) 12 months option periods for a total of four (4) years. The Government may extend the period of performance in accordance with 52.217-9 – Option to Extend the Term of the Contract;

upon written notification by the Contracting Officer within 30 days of contract expiration or within 30 days of funds becoming availability for that fiscal year. (Dates subject to changes based on award)

Base Period: February 15, 2012 through February 14, 2013 Option Period 1: February 15, 2013 through February 14, 2014 Option Period 2: February 15, 2014 through February 14, 2015 Option Period 3: February 15, 2015 through February 14, 2016

F.3. OBSERVANCE OF FEDERAL HOLIDAYS

No services or deliveries shall be performed on Saturdays, Sundays or Federal legal holidays. Deliverables due on a Saturday, Sunday, or Federal holiday shall be due on the following business day.

1. New Year’s Day January 1st

2. Martin Luther King’s Birthday Third Monday in Jan.

3. President’s Day Third Monday in Feb.

4. Memorial Day Last Monday in May

5. Independence Day July 4th

6. Labor Day First Monday in Sept.

7. Columbus Day Second Monday in Oct.

8. Veteran’s Day November 11

9. Thanksgiving Day Fourth Thursday Nov.

10. Christmas Day December 25

F.4. REPORTING REQUIREMENTS/DELIVERABLES

The contractor shall submit deliverables that are clear, concise, and complete, and that conform in format and structure to standards that shall be agreed to in advance between the Contractor and the COTR. Certain types of deliverables shall be submitted in draft form initially, allowing the COTR to review and provide additional information and/or clarification comments for possible inclusion in the final version.

F.5. DELIVERABLES

Description Quantity Due Date

Baseline Orientation ‐ Includes description of timetable to offer user services ‐ Deliver communication tools regarding methods to access, obtain password, user guide information

‐ Provide plan for communications and trouble shooting with users

‐ Identify plan for offering consulting services and project design and analysis

1 Within two weeks of the initiation of the contract

Provide Access to data modeling and simulation platform systems

Provide access of 50 users per year (total active subscriptions)

Provide user access within 72 hours of submitting request

Provide upon user request capability to design and develop customized modules, displays, and integration of user provided data sets

Provide up to 1000 hours of consulting and computing per year

Provide reports at completion of each subtask

Webinar and education training sessions ‐ Provide user education on basic operations demonstrating common use of platform systems modules

‐ Demonstrate communication methods for questions, or technical information

‐ Provide feasibility for two onsite demonstration and user interface listening and training sessions

‐ Provide communication plan for new users

Minimum of 2 live sessions per year

Notification 30 days in advance of the education sessions

Provision of communication log and details regarding troubleshooting for users

‐ Performs annual survey of customer satisfaction of users each year and provides summary to COTR

1 30 days prior to the completion of each contract year

Annual Progress report ‐ Details upgrades, uses, complaints, troubleshooting ‐ Provides brief description of customized projects, including budgets

1 Due within 30 days of the completion of the contract year

Report on User agreements ‐ Provides COTR with name, agency and email address of new user subscription

1 Quarterly

Note: All deliverables shall be conveyed to the Government in a format (electronic or paper) as specified on the Task Order.

F.6. FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/

CLAUSE TITLE DATE

52.242-15 Stop-Work Order August 1989

52.242-17 Government Delay of Work April 1984

SECTION G – CONTRACT ADMINISTRATION DATA

G.1. AUTHORITIES OF GOVERNMENT PERSONNEL

Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contract will require coordination between the Government and the Contractor. The following individuals will be the Government’s points of contact during performance of the contract.

1. Contracting Officer All contract administration shall be done by:

Dawn Gresham, Contracting Officer Program Support Center, Division of Acquisition Management 5600 Fishers Lane Parklawn Building, Room 5-101 Rockville, MD 20857 Phone: (301)443-5148 Fax: (301)443-8488 Email: Dawn.Gresham@hhs.gov All communications pertaining to contractual and/or administrative matters under the contract shall be sent to the address above and to the attention of:

Wendy Cruz Contract Specialist Phone: (301)443-3086 Email: Wendy.Cruz@psc.hhs.gov Note: The PSC Contracting Officer is the only individual authorized to modify this requirement.

2. Contracting Officer's Technical Representative (COTR) To be provided after solicitation process is complete.

3. Technical Monitoring

Performance of work under this contract must be subject to the technical direction of the Contracting Officers’ Technical Representative identified above, or a representative designated in writing. The term “Technical Direction” includes, without limitation, direction to the contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks outlined in the work statement are accomplished satisfactorily.

Technical direction must be within the scope of the specification(s)/work statement. The Contracting Officers’ Technical Representative does not have authority to issue technical direction that:

• Constitutes a change of assignment or additional work outside the specification(s)/statement of work;

• Constitutes a change as defined in the clause entitled “Changes”;

• In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

• Changes any of the terms, conditions, or specification(s)/work statement of the contract;

• Interferes with the contractor's right to perform under the terms and conditions of the contract; or

• Directs, supervises or otherwise controls the actions of the contractor's employees.

Technical direction may be oral or in writing. The Contracting Officers’ Technical Representative shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer. The contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officers’ Technical Representative. If, in the opinion of the contractor, any direction of the Contracting Officers’ Technical Representative, or his/her designee, falls within the limitations above, the contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day. Failure of the contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled “Disputes.”

G.2. TASK ORDER PROCEDURES

The Contractor will be provided with a Statement of Work from the Contract Specialist/Contracting Officer that includes performance based standards, anticipated period of performance, Schedule of Deliverables and other additional instructions as needed for each individual task order to be issued under this contract. These documents, collectively referred to as a Task Order Request for Proposal (TORFP) may be issued by mail, facsimile or electronic means. The Contractor shall be required to submit separate cost and technical proposals for each task order that is issued under this contract. E-mailed proposals are acceptable with the approval of the Contracting Officer. Each task order will contain the following minimum information:

1. Date of order;

2. Contract number and Task Order number (to be numbered consecutively);

3. Estimated total dollar amount of the task order;

4. Statement of Work, Schedule of Deliverables and any special instructions;

5. Period of performance;

The contractor shall submit separate invoices for each task order and include the IDIQ contract number as well as the Task Order number.

G.3. INVOICE SUBMISSION

The Contractor shall submit an invoice including supporting documentation on a per task order basis via email to the COTR and Contract Specialist.

Division of Acquisition Management/Program Support Center Attention: Wendy Cruz Parklawn Building, Room 5-101 5600 Fishers Lane Rockville, Maryland 20857 Contract Number:

At the same time, the Contractor shall submit one (1) copy of the invoice without supporting documentation via email to FMS email PSC_Invoices@psc.hhs.gov on a per task order basis, to:

PSC/Financial Management Service Division of Financial Operations Parklawn Building, Room 16A-12 5600 Fishers Lane Rockville, Maryland 20857 Contract Number:

1. In addition to the information required by SECTION I, Clause 52.232-25, the following information is also required for submission of a proper invoice. The Contractor shall include the following minimum information on invoices:

a. Contractor's name and invoice date;

b. Contract number or other authorization for delivery of property or services;

c. Description, price, and quantity of property or services actually delivered or rendered;

d. Shipping and payment terms;

e. Other substantiating documentation or information as required by the contract;

f. Name (where practicable), title, telephone number, and complete mailing address of responsible official to whom payment is to be sent;

g. The Internal Revenue Service TAX IDENTIFICATION; and

h. Signature of an authorized official certifying the invoice to be correct and proper for payment.

2. Payment shall be made by:

PSC/Financial Management Service Division of Financial Operations Parklawn Building, Room 16A-12 5600 Fishers Lane Rockville, Maryland 20857

FOR INVOICE STATUS CALL: (301) 443-3020

Payment by Electronic Funds Transfer Pursuant to FAR 52.232-33, Payment by Electronic Funds Transfer –Central Contractor Registration, payments under this contract shall be made by electronic funds transfer.

The Contractor shall register in the Central Contractor Registration database

G.4. GOVERNMENT FURNISHED PROPERTY/EQUIPMENT

No space or equipment will be provided by the Government under this contract. The contractor is responsible for all equipment, supplies, and space required to provide services under this contract.

G.5. DATA TO BE DELIVERED

Any working papers, interim reports, data given by the Government or first produced by the contractor under the contract or collected or otherwise obtained by the contractor under the contract, or results obtained or developed by the contractor, including any subcontractors or consultants, pursuant to the fulfillment of this contract are to be delivered, documented, and formatted as directed by the COTR.

In addition, information and data, which are held by the contractor related to the operation of their business and/or institution and which are obtained without the use of federal funds, shall be considered “PROPRIETARY DATA” and are not “subject data” to be delivered under this contract.

SECTION H – SPECIAL CONTRACT REQUIREMENTS

H.1. ORGANIZATIONAL CONFLICT OF INTEREST AND CONFIDENTIALITY

In order to avoid any organizational conflict of interest, the contractor including its parent company, subsidiaries, and subcontractors, if any, shall not be biased because of its financial, contractual, organizational, or other interests which relate to the work under this requirement, and does not obtain any unfair competitive advantage over other parties by virtue of its performance of this requirement. Any conflict of interest must have prior Governmental approval. Furthermore, to preserve the contractor’s independence and effectiveness, the contractor shall maintain strict confidentiality of information that is provided by the Government during the performance of the contract.

Information provided to and received from the contractor is considered the government’s property. Data is classified as confidential. All contractor personnel will be required to wear a PSC contractor issued badge while in a government facility. The contractor shall conduct its business in a manner befitting the special relationship with the Government, operating in the public interest with objectivity and independence.

Prior to working on this contract, contractor employees shall be required to sign a “Certificate of Confidentiality and Non-Disclosure Agreement” (see Attachment D) to ensure protected health information is not shared or mistreated.

The government will determine whether a conflict of interest exists during its evaluation.

Any proposal determined to violate this conflict of interest restriction will be deemed non-responsive and will be disqualified from further evaluation.

H.2. PERFORMANCE CRITERIA AND QUALITY ASSURANCE SURVEILLANCE

PLANS

The Contractor’ approved Quality Assurance Surveillance Plan (QASP) shall be incorporated as part of the contract.

See Section C.4.6. for performance standards.

H.3. ORGANIZATIONAL SECURITY AND CONFIDENTIALITY

The contractor shall maintain strict confidentiality of all information that is provided by the Government during the performance of the contract. Information provided to and received from the contractor is considered the government’s property. Data is classified as confidential. All contractor personnel will be required to wear an HHS visitor issued badge while in a government facility. The contractor shall conduct its business in a manner befitting the special relationship with the Government, operating in the public interest with objectivity and independence.

H.4. CONTRACTOR PERFORMANCE EVALUATION REPORT

The Contractor’s performance shall be evaluated annually. This evaluation shall become a part of the contract file and shall be used as past performance information in evaluating the Contractor’s and any significant subcontractors’ or affiliates’ past performance on future contracts. The Contractor shall be given a minimum of 30 days to submit comments, rebutting statements, or additional information. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews.

Information on CPARS can be located at http://www.cpars.csd.disa.mil/cparsmain.htm.

H.5. HANDLING OF DATA

The Contractor agrees to the extent that it receives or is given access to data necessary for the performance of any task order which contains restrictive markings, the Contractor shall treat the data in accordance with such markings unless otherwise specifically authorized in writing by the Contracting Officer.

H.6. IT SYSTEMS SECURITY REQUIREMENTS

The contractor agrees to comply with IT systems security provisions, including designated category of safe-guarded positions and position sensitivity designations to ensure the adequate safeguard of agency information being accessed by the contractor.

All data, information, analysis, results, and requirements will be turned over to HHS. All contract personnel may be subject to satisfactory completion of appropriate personnel suitability/security investigations. All contractor staff that will be performing work on this contract must be U.S. citizens and identified prior to commencement of the contract.

Permanent resident aliens and other similar legally-authorized alien employees should comply with e-Verify procedures. All contractor staff that will be performing work on this contract will be required to sign Non-Disclosure Agreements with the U.S. government.

H.7. RIGHTS IN DATA

Notwithstanding any other clause concerning data, data rights and computer software and hardware under this contract, all data produced, recorded, transferred or manipulated under this contract shall remain the exclusive property of the Government irrespective of the manner or method of recording or storage and no matter what form of computer mechanism is used in the processing of said information or data. The Government shall retain exclusive right and domain over any by-product produced under this contract, or any other use of the data produced under this contract by either plan or accident.

a. "Data," as used herein, means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management.

The term "Technical Data", as used herein, means recorded information, regardless of form or characteristic, of a scientific or technical nature. It may, for example, document research, experimental, developmental or engineering work, or be usable or used to define a design or process or to procure, produce, support, maintain, or operate material. The data may be graphic or pictorial delineations in media such as drawings or photographs, text in specifications or related performance or design type documents or computer printouts. Examples of technical data include research and engineering data, engineering drawings and associated lists, specifications, standards, process sheets, manuals, technical reports, catalog item identifications, and related information, and computer software documentation. Technical data does not include computer software or financial, administrative, cost and pricing, and management data or other information incidental to contract administration.

The term "Computer Software", as used herein means Computer Programs and Computer Data Bases. "Computer Programs", as used herein means a series of instructions or statements in a form acceptable to a computer, designed to cause the computer to execute an operation or operations. Computer Programs include operating systems, assemblers, compilers, interpreters, data management systems, utility programs, sort merge programs, and ADP maintenance diagnostic programs, as well as applications programs such as payroll, inventory control and engineering analysis programs. Computer Programs may be either machine-dependent or machine independent, and may be general-purpose in nature or designed to satisfy the requirements of a particular user.

The term "Computer Data Bases", as used herein, means a collection of data in a form capable of being processed and operated on/by a computer.

b. All data first produced in the performance of this Order shall be the sole property of the Government. The Contractor hereby acknowledges that all data, including, without limitation, computer program codes, produced by the Contractor for the Government under this Order, are works made for hire and are the sole property of the…