Attachment_1_Trauma_Inventory_SOW.pdf

STATEMENT OF WORK (SOW)

Developing an Inventory of Trauma, Emergency, & Burn Capabilities in the United States

Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

1.0 BACKGROUND

Trauma Care

The entire American public is susceptible to injuries, regardless of of age, gender, race, or socioeconomic status. According to the U.S. Department of Health and Human Services’ (HHS)

Centers for Disease Control and Prevention (CDC), every three minutes an American dies from violence and injuries, which translates to nearly 192,900 deaths a year.

Trauma is defined as “severe blunt, blast, or penetrating injury primarily caused by automobile crashes, gunshots, knife wounds, falls, battery, or burns.”

The terms “trauma” and “injuries” are frequently used interchangeably. Trauma ranges in severity from mild (contusions and abrasions) to severe life and limb threats. Roughly half of Americans can access a hospital with the highest tier of capabilities to manage severely injured patients within 60 minutes via ground ambulance, while 83 percent have access within an hour by air ambulance (helicopter).

3,4

However, as a result of geographic variation in access and other drivers, more than half (54%) of severely injured patients were not treated at trauma centers according to data from 2009.

Trauma Centers

Injuries are treated in a variety of settings from general emergency departments (EDs) (e.g.

freestanding EDs), to community hospitals, to specialized hospitals with the resources to optimally manage the most severely injured patients (trauma centers). Trauma centers are typically designated by state agencies based on guidelines developed by the American College of

Surgeons’ Committee on Trauma (ACS-COT), and are assigned “levels” I-V based on their capabilities, with Level I being those with the greatest capabilities. These centers must be regularly evaluated and certified by their respective credentialing bodies.

Burn Care

Burn is defined as an “injury to the skin or other organic tissue primarily caused by heat or due to radiation, radioactivity, electricity, friction or contact with chemicals.”

6,7

Burn injuries are associated with over 500,000 ED visits, about 50,000 acute admissions, and roughly 4,000 burn-related deaths.

Substantially fewer U.S. hospitals are burn centers than trauma centers.

1 Centers for Disease Control and Prevention. Violence and Injuries Affect Everyone. 2015; http://www.cdc.gov/injury/about/. Accessed

December 9, 2015.

2 American Trauma Society. About the American Trauma Society. http://www.amtrauma.org/?page=About. Accessed December 8, 2015.

3 Carr B, Branas C. TraumaMaps.org - Trauma Center Maps. 2006 4 Branas CC. No time to spare: improving access to trauma care. LDI Issue Brief. 2005;11(1):1-4.

5 Delgado MK, et al. Factors associated with the disposition of severely injured patients initially seen at non-trauma center emergency departments: Disparities by insurance status. JAMA Surg. 2014;149(5):422-430.

6 World Health Organization, Violence and Injury Prevention. Burns. http://www.who.int/violence_injury_prevention/other_injury/burns/en/.

Accessed December 8, 2015.

7 Klein MB, Kramer CB, Nelson J, Rivara FP, Gibran NS, Concannon T. Geographic access to burn center hospitals. JAMA. 2009;302(16):1774-

1781.

8 American College of Surgeons, Committee on Trauma, American Burn Association. Chapter 14: Guidelines for the Operation of Burn Centers.

Resources for Optimal Care of the Injured Patient. Chicago, IL: American College of Surgeons; 2006.

http://www.cdc.gov/injury/about/ http://www.amtrauma.org/?page=About http://www.who.int/violence_injury_prevention/other_injury/burns/en/

American Burn Association (ABA) and ACS jointly verify burn centers through a comprehensive review program.

Nearly 80 percent of Americans have access within 120 minutes by ground or air ambulance to a hospital with specialty burn capabilities.

Over half of acute hospitalizations for burn injuries are admitted to 128 burn centers, yet properly referring patients to burn centers remains a challenge as almost a quarter of patients who would benefit from burn care are admitted to non-specialized hospitals.

Pediatric Trauma and Burn Care

The pediatric population is distinct in many ways in its needs for trauma and burn care relative to the adult population. Despite the existence of specialized children’s hospitals, only an estimated

11 percent of injured children are seen at pediatric hospitals, and only 13 percent are cared for at hospitals with some trauma credentialing.

Specialty designation for hospitals exists for pediatric trauma care. An estimated 17.4 million children do not have access to pediatric trauma care within an hour.

Population analyses suggest that states with pediatric trauma centers have lower pediatric injury mortality rates.

There is little to no data assessing pediatric burn center access.

Emergency care

Most 24 hour receiving EDs in the US are neither trauma centers, burn centers, nor pediatric specialty hospitals. Emergency care in the US is delivered in general community hospitals, academic medical centers, Department of Defense affiliated hospitals (for active military and dependents), Department of Veterans Affairs affiliated hospitals, and hospitals affiliated with the

Indian Health Services. These facilities have variable resources and capabilities to manage acutely ill and injured patients and these limits impact the ability of patients, family members, and emergency medical services to match supply with demand. An understanding of the emergency care capabilities pertinent to medical, surgical, and mental health across the spectrum of children, adults, and the geriatric population would help to improve emergency care delivery in the US. Efforts have taken place to make these resources more visible to patients and providers but this work is not as advanced as for burn and trauma where clearly outlined capabilities are transmitted to end users (public, EMS, emergency management).

16,17

9 American Burn Association. Burn Incidence and Treatment in the United States: 2015. 2015;

http://www.ameriburn.org/resources_factsheet.php. Accessed December 9, 2015.

10 Ibid.

11 Zonies D, Mack C, Kramer B, Rivara F, Klein M. Verified centers, nonverified centers, or other facilities: a national analysis of burn patient treatment location. Journal of the American College of Surgeons. 2010;210(3):299-305.

12 Densmore JC, Lim HJ, Oldham KT, Guice KS. Outcomes and delivery of care in pediatric injury. J Pediatr Surg. 2006;41(1):92-98; discussion

92-98.

13 Segui-Gomez M, Chang DC, Paidas CN, Jurkovich GJ, Mackenzie EJ, Rivara FP. Pediatric trauma care: an overview of pediatric trauma systems and their practices in 18 US states. J Pediatr Surg. 2003;38(8):1162-1169.

14 Nance ML, Carr BG, Branas CC. Access to pediatric trauma care in the United States. Arch Pediatr Adolesc Med. 2009;163(6):512-518.

15 Notrica DM, Weiss J, Garcia-Filion P, et al. Pediatric trauma centers: correlation of ACS-verified trauma centers with CDC statewide pediatric mortality rates. J Trauma Acute Care Surg. 2012;73(3):566-570; discussion 570-562.

American College of Emergency Physicians. Increasing transparency of hospital acute care capabilities: Consumer-centered decision criteria for unscheduled medical care. 2015.

Hold for GW reference once published in Annals http://www.ameriburn.org/resources_factsheet.php

Psychiatric Emergency Care

Emergency care for psychiatric conditions is a vital service for affected patients. According to the National Institute of Mental Health, an estimated 18.1% (43.6 million) of U.S. adults have a diagnosable mental illness.

Despite this prevalence, outpatient and inpatient mental health treatment are widely regarded to have insufficient capacity to meet patient demand.

As a result, EDs often serve as a mental health safety net. In 2007, roughly one out of every eight ED visits

(roughly 12 million) involved patients with a mental health and substance abuse (MHSA) diagnosis.

This high volume has led to concerns about ED overcrowding and boarding. At the same time, some EDs may not offer psychiatric services (either in terms of on-call psychiatrists or affiliated inpatient psychiatric beds) and must transfer patients with these acute mental health conditions. Advising patients on which facilities offer emergency psychiatric care will allow them to make more informed decisions for their care.

Trauma and Burn Systems of Care

Trauma care is known to markedly reduce injury-related mortality, has been celebrated by the

IOM, and has been recognized by the public as a valuable resource.

A fundamental premise of

U.S. trauma care is that care is optimized only by building a “system of care.” This system consists of a complex cadre of regularly interacting and interdependent stakeholders to form a unified whole.

Given the time-sensitive nature of survival after serious injury, the goal of this system is to get patients to the right care at the right time (e.g., patients are treated at the facility most appropriate to treat the extent of their injuries as quickly and effectively as possible). Trauma care systems in which all facilities have a clear role in trauma care (inclusive systems) have been associated with improved population-based outcomes for injuries compared to exclusive systems (designation of

Level 1 and 2 trauma centers without coordination between other facilities).

23,24

Data Gaps

It is difficult to develop, design, and maintain high functioning systems of trauma and burn care without accurate data on the location and capabilities of emergency care, trauma care, and burn care centers. The data cited above (and widely in the literature) on patient access to care is largely from 2010, the last year such data was routinely collected. The pediatric data is even older (2006). Improving population access to trauma care is a Healthy People 2020 priority.

Additionally, in their report entitled A National Trauma Care System: Integrating Military and

Civilian Trauma Care Systems to Achieve Zero Preventable Deaths After Injury, The National

Academies of Sciences, Engineering, and Medicine have called upon the Department of Health and Human Services (HHS) to take a leadership role in and to improve the collection and use of

18 https://www.nimh.nih.gov/health/statistics/prevalence/use-of-mental-health-services-and-treatment-among-adults.shtml

Institute of Medicine. Committee on Crossing the Quality Chasm: Adaptation to Mental Health and Addictive Disorders. Improving the

Quality of Health Care for Mental and Substance-Use Conditions. Washington, D.C.: National Academies Press. 2006.

20 http://www.hcup-us.ahrq.gov/reports/statbriefs/sb92.pdf 21 MacKenzie EJ, Rivara FP, Jurkovich GJ, et al. A national evaluation of the effect of trauma-center care on mortality. The New England journal of medicine. 2006;354(4):366-378.

22 Institute of Medicine. Future of Emergency Care: Dissemination Workshop Summaries. Washington, DC: The National Academies Press;

2007: http://www.nap.edu/catalog/11926/future-of-emergency-care-dissemination-workshop-summaries. Accessed December 9, 2015.

23 Resources for the optimal care of the injured patient. (Accessed January 9, 2015, at https://www.facs.org/quality_programs/trauma/vrc.)

24 Esposito TJ, Sanddal TL, Reynolds SA, Sanddal ND. Effect of a voluntary trauma system on preventable dealth and inappropriate care in a rural state. J Trauma 2003;54:663-9.

http://www.nap.edu/catalog/11926/future-of-emergency-care-dissemination-workshop-summaries data for trauma care.

This RFP seeks to support that priority, improve transparency to the

American Public including the research community, and improve situational awareness in order to improve emergency response in the event of disasters and public health emergencies.

This project seeks to advance the Emergency Care Coordination Center’s dual interests in developing patient and community centered emergency care systems and preparing to respond in times of public health emergencies by developing an inventory of hospitals’ emergency, trauma, and burn capabilities in the US.

2.0 PURPOSE AND OBJECTIVES OF THE ACQUISITION

The objective of this statement of work (SOW) is to create a comprehensive national inventory of EDs, trauma centers, and burn centers for adults and children and it also requires maintaining and updating this inventory database. The National Academies of Sciences, Engineering, and

Medicine have called for HHS to take a leadership role in and to improve the collection and use of data for trauma care. A comprehensive national inventory which delineates the resources and capabilities of the US emergency, trauma, and burn care system is critical in order to ensure situational awareness and improve injury related outcomes in this space.

This project addresses specific tasks in the ASPR strategic plan including: the development of patient and community centered emergency care systems and the development of an evidence-based system to understand the acute care capabilities of hospitals in order to improve patient decision making, EMS protocols, emergency management, and healthcare coalition development.

The project’s ultimate goal is to improve the day-to-day care of ill and injured patients and to develop the infrastructure needed to adequately respond to disasters and public health emergencies. In line with the National Academies’ recommendation, it is critical to have a thorough understanding of emergency, trauma, and burn facilities’ locations and capabilities to lead a sustained effort to improve outcomes in this space. It is our goal to subsequently leverage this information to support national planning and preparedness efforts. Making transparent the capabilities of the US trauma and burn system will allow for enhanced situational awareness, informed-patient decision making, improved pre-hospital destination protocols, and national preparedness.

The initial year of this project will require the formulation of a stakeholder engagement process to identify key data elements to include in a comprehensive national inventory of EDs, trauma centers, and burn centers, and the development of the inventory of facilities and their ability to manage acutely ill and injured patients (trauma capabilities, burn capabilities, medical, surgical, and psychiatric emergencies including for special populations such as pediatric and geriatric patients). Engagement of a broad range of key stakeholders from health professional societies, the research community, policy makers, patient advocates, EMS, and emergency management communities is required. In addition to key stakeholders, input from key federal partners such as the Emergency Medical Services for Children program in the Health Resources and Services

25 National Academies of Sciences, Engineering, and Medicine. A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. Washington, D.C.: The National Academies Press; 2016.

Administration, the Office of Emergency Medical Services in the Department of Transportation, and representatives from the Office of Emergency Management and Office of Policy and

Planning at ASPR will be expected. Using the information gained from stakeholder engagement activities, the base year of this project will additionally require the development of a comprehensive national inventory of the location and capabilities of EDs, trauma centers, and burn centers (including pediatrics), and the subsequent dissemination of this inventory.

Option Periods 1 through 4 of this initiative (to be executed solely at the discretion of the government) are to expand the application of the inventory developed in the base year to further support national emergency care system planning, including, for instance, the development of a sustainable model for ongoing data collection and dissemination or using the inventory to develop a mapping interface that provides a basic visual representation of population access to trauma and burn centers in the U.S. The contractor shall disseminate the expanded inventory, test the usability of the expanded inventory, and provide feedback from stakeholders on the importance of this information for supporting national emergency care system planning.

3.0 CONTRACTOR TECHNICAL REQUIREMENTS/TASKS

3.1.BASE YEAR

The base year project shall consist of the following tasks.

a. Initial Kick-Off Meeting. The contractor shall meet with DHSP staff within 1 week of the contract award. The purpose of the meeting is for DHSP and contractor staff to review the following and answer any questions the contractor may have. This may occur in person (if local) or via telephone conference.

i. Project Management Plan

ii. Goals

iii. Objectives

iv. Scope of work including methods, work plans, products, and deliverables

v. Delivery Schedule

vi. Delineate roles and responsibilities

vii. Establish communication protocols

b. The contractor shall provide a work plan update not later than the 10 th of each month. The work plan update shall include key tasks to be accomplished, key personnel involved, a timeline for accomplishment of tasks, areas of high risks that may affect the accomplishment of key events, and plans to mitigate these risks.

c. The contractor shall conduct a minimum of three (3) stakeholder sessions to determine the minimal set of data elements to include in the national inventory of EDs, trauma centers, and burn centers. The stakeholder sessions should include but not be limited to professional societies, the research community, policy makers, EMS, and disaster communities, healthcare coalitions, emergency managers, physicians, patient stakeholders, and hospital administrators. See sub-section (i.) below for a list of recommended organizations to contact for focus group members. The organizations listed in sub-section (i.) should not be considered as mandatory or as an exclusive list for focus group member recruitment.

Proposed focus group membership will be reviewed by the government for comments regarding focus group composition balance. Final selection of focus group members shall be the responsibility of the contractor.

i. List of recommended organizations to contact for focus group members:

AARP

American Association of Medical Colleges (AAMC)

Academy Health

Advocates for EMS

America's Essential Hospitals

American Academy of Emergency Medicine

American Academy of Family Physicians

American Academy of Orthopaedic Surgeons / American Association of Orthopaedic

Surgeons (AAOS)

American Academy of Pediatrics

American Association for the Surgery of Trauma

American Association of Neurological Surgeons / Congress of Neurological Surgeons

American Board of Emergency Medicine

American College of Emergency Physicians (ACEP)

American College of Osteopathic Emergency Physicians (ACOEP)

American College of Surgeons

American Heart Association

American Hospital Association (AHA)

American Medical Association

American Nurses Association

American Orthopaedic Association (AOA)

American Public Health Association (APHA)

American Trauma Society (ATS)

Association of Air Medical Services (AAMS)

Association of Critical Care Transport (ACCT)

Association of Emergency Physicians

Best Practices in Emergency Services

Consumer Health Foundation

Emergency Nurses Association

Families USA

Kaiser Family Foundation

National Association of County & City Health Officials (NACCHO)

National Association of EMS Educators (NAEMSE)

National Association of EMS Physicians (NAEMSP)

National Association of EMTs (NAEMT)

National Association of State EMS Directors (NASEMSD) - Medical Directors Council

National Association of State EMS Officials (NASEMSO)

National Collegiate Emergency Medical Services Foundation

National Medical Association

National Native American EMS Association (NNAEMSA)

National Registry of Emergency Medical Technicians (NREMT)

National Rural Health Association (NRHA)

Patient Advocate Foundation

Pediatric Academic Society

Patient-Centered Primary Care Collaborative

Patients Like Me

Society for Academic Emergency Medicine (SAEM)

Society of Emergency Medicine Physician Assistants (SEMPA)

The Beryl Institute

Trauma Center Association of America (TCAA)

ii. Qualitative research methods including but not limited to the running of focus groups, the use of Delphi methods, and/or survey methods to identify and convene key stakeholders and determine the minimal set of data elements, including methods to reconcile conflicting information (e.g. level of trauma center), may be utilized. In contrast to the data elements of existing databases (including the AHA Hospital Database) which do not focus on a specific system of care, stakeholders should focus their discussion on elements specific to the US emergency, trauma, and burn care system. The engagement process shall include but is not limited to addressing the following possible data elements:

Facility name and contacts (e.g. Trauma Medical Director, Emergency Management contact, Trauma Coordinator, etc.)

Facility capabilities (e.g. trauma level, burn center level, pediatric trauma level, pediatric burn level), including a reconciliation of different trauma/burn levels determined by different credentialing bodies (e.g. state, professional groups, etc.)

Facility demographics (e.g. address, telephone number, health system affiliation, AHA unique identification number, health information exchange participation, EMR vendor, etc.)

Capacity/volume/acuity (e.g. number of beds (including ICU, pediatric ICU, ED treatment spaces, trauma beds, etc.), total annual trauma volume, percentage of severe trauma patients (ISS>15), percentage of patients with severe burns, number of major resuscitations, number of operative trauma cases, % pediatric, % geriatric, etc.)

Facility capabilities (e.g. presence of a 24-hour staffed ED, surgical sub-specialists, ICU staffing, off-hour subspecialty availability, mental health crisis resources, etc.)

d. The contractor shall provide a comprehensive report of the outcomes of Task (3.1.c.)

describing what data elements to include in the inventory of EDs, trauma center, and burn center capabilities.

e. Building upon the lessons learned in (3.1.c.), the contractor shall develop and submit for approval a written plan for collecting, storing, and maintaining the required data elements.

This plan shall include but is not limited to addressing data sources, methods for obtaining data, methods to validate the accuracy of data, a system for housing the data, a method for updating and sustaining the data (including a discussion of how often to update the data and associated cost estimates). This plan shall additionally include a discussion of associated benefits and challenges (e.g. survey response rates, the need for data use agreements, etc.).

This plan shall also include proposed steps to incrementally expand the application of the inventory in option year 1, and include an explanation of how the expanded inventory will support national emergency care planning.

f. The contractor shall utilize the information collected in (3.1.c.) and the plan developed in

(3.1.e.) to develop an easily interpretable inventory– appropriate for patients, EMS, and others - by which to determine the capabilities of EDs, trauma centers, and burn centers

(including pediatrics). The contractor shall vet and iteratively modify the developed inventory with the government and the research, policy, EMS, disaster communities, emergency managers, physicians, and hospital administrators to assure that it captures the multiple important perspectives of stakeholders.

g. The contractor shall develop and submit for approval to the COR a plan to distribute the inventory developed in (3.1.f.) to stakeholders.

h. The contractor shall distribute the inventory to stakeholders according to the distribution plan developed in (3.1.g.)

3.2. OPTION YEARS 1 - 4

The Option Years 1 - 4 projects, to be executed solely at the discretion of the government, shall consist of the following tasks:

a. The contractor shall provide a work plan update not later than the 10 th of each month. The work plan update shall include key tasks to be accomplished, key personnel involved, a timeline for accomplishment of tasks, areas of high risks that may affect the accomplishment of key events and plans to mitigate these risks.

b. The contractor shall incrementally with HHS prior approval expand the application of the inventory developed in (3.1.f.) to support national emergency care planning, including the development of a sustainable model for ongoing data collection and dissemination.

c. The contractor shall develop and submit for approval to the COR a plan to distribute the expanded inventory developed in (3.2.b.) to stakeholders, including those in the research, policy, EMS, and disaster communities.

d. The contractor shall distribute the expanded inventory to stakeholders according to the distribution plan developed in (3.2.c.)

e. The contractor shall within six (6) months of the start of each option year provide details of plans and cost estimates to incrementally expand the application of the inventory developed in (3.1.f.) in the succeeding Option Year. This should include an explanation of how the expanded application of the inventory will support national emergency care planning, including the development of a sustainable model for ongoing data collection and dissemination. Examples of expanded application may include but are not limited to using the system to develop a mapping interface that provides a basic visual representation of population access to trauma and burn centers in the U.S., expanding the list of capabilities included in the inventory, engaging healthcare coalitions to use the inventory to support state emergency care planning, calculating and visually depicting access to trauma care resources by ground or air ambulance, creating patient and EMS centered apps for handheld devices, and determining the optimal configuration of trauma care resources.

4.0 CONTRACTOR SUPPLIED MATERIALS

The contractor shall provide all personnel, equipment, supplies, and services necessary to fulfill the terms of this contract.

5.0 GOVERNMENT FURNISHED RESOURCES AND INFORMATION

No facilities, supplies, and services will be provided by the government to the contractor to accomplish the work specified in this SOW. All government information and documents required to accomplish the work specified in this SOW can be obtained from public accessible websites.

6.0 REPORTING REQUIREMENTS AND DELIVERABLES

a. Base Year. The following deliverables shall be provided to the COR under this contract:

SOW

TASK NO.

DECRIPTION

DUE DATE

Partial-Payment a.

Present Project Management

Plan at Kick-off Meeting

One week after effective date of contract

None

b. Monthly Updates th Calendar Day of each month

4% of the base year award for each monthly update

c. 3 stakeholder sessions Within four (4) months of award

None d.

Comprehensive report of the outcomes of the stakeholder sessions

Within five (5) months of award

5% of the base year award e.

Written plan for collecting, storing, and maintaining required data elements and proposed steps for incremental expansion

Within six (6) months of award

5% of the base year award f.

Development of an inventory by which to determine the capabilities of EDs, trauma centers, and burn centers

(including pediatrics)

Within nine (9) months of award

21% of the base year award

g. Submit distribution plan Within nine (9) months of award

None

h. Distribution of the inventory Within ten (10) months of award

21% of the base year award

b. Option Years 1-4. The following deliverables shall be provided to the COR under this contract:

SOW

TASK NO. DECRIPTION DUE DATE Partial-Payment

a. Monthly Updates th Calendar Day of each month

4% of the option period award for each monthly update b.

Development of the expanded inventory to support national emergency care planning

Within five (5) months of award

32% of the option period award c.

Submit revised distribution plan

Within five (5) months of award

None d.

Distribution of the expanded inventory

Within six (6) months of start of option year

15% of the option period award e.

Details of plan to expand the application of the inventory

Within months (6) of the start of Option Year

5% of the option period award

7.0 INSPECTION AND ACCEPTANCE

Inspection and acceptance of the product, services, and documentation called for under this Contract shall be accomplished by the CO or a duly authorized representative at the destination of the product, services or documents.

8.0 REQUIRING ORGANIZATION

Department of Health and Human Services

OS/ASPR/OPP/DHSP/ECCC

200 C St SW

Washington, D.C. 20024

9.0 APPLICABLE DOCUMENTS

ASPR Strategic Plan

Paperwork Reduction Act of 1995 (44 U.S.C 3501 et seq).

10.0 DELIVERY INSTRUCTIONS

The contractor shall deliver all written work products to the Government designated COR.

These documents shall be provided in plain English, on white office paper, and in electronic format prepared using Microsoft Office product software (e.g., Word, Excel, Project, PowerPoint), as applicable.

11.0 PERFORMANCE/DELIVERY PERIOD

The period of performance for the contract is a base period of 12 months from the date of award and four (4) one-year options to be executed solely at the discretion of the government.

12.0 CONTRACT TYPE

Firm Fixed Price

13.0 PLACE/LOCATION OF PERFORMANCE/DELIVERY

The place of performance will be at facilities selected by the contractor. All deliverables will be provided to the COR at:

PHYSICAL ADDRESS:

The Thomas P. O’Neill Federal Building

200 C Street, SW

Washington, DC 20024

MAILING ADDRESS

ASPR/OPP/DHSP

200 Independence Ave, SW

14.0 TRAVEL REQUIREMENTS

Travel, subject to the Federal Travel Regulations, may be required under this contract but only when specifically authorized in writing by the Contracting Officer. Reimbursement by HHS for local travel is not authorized.

15.0 REQUIREMENTS FOR HANDLING SENSITIVE/PROPRIETARY

INFORMATION

Use of sensitive or proprietary information is not anticipated. If however, sensitive or proprietary information is a factor that the data clauses do not cover, this will be discussed between HHS and the Contractor.

16.0 CONFIDENTIALITY AND OWNERSHIP

All documents, photocopies, computer data and any other information of any kind collected or received by the Contractor in connection with the contract work shall be provided to the HHS upon request at the completion of the contract/task order(s) (i.e., the date on which final payment is made on the contract or at such other time as may be requested by the Contracting Officer or as otherwise agreed by Contracting Officer and the Contractor). If the contractor modifies its version of the data or program after the period performance is complete, any associations with

DHHS will be removed from the data or associated programs before use.

The Contractor may not discuss the contract work in progress with any outside party, including responding to media and press inquiries, without the prior written permission of the HHS. In addition, the Contractor may not issue news releases or similar items regarding contract award, any subsequent contract modifications, or any other contract-related matter without the prior written approval of the Contracting Officer. Requests to make such disclosure should be addressed in writing to the Contracting Officer.

17.0 508 COMPLIANCE

The awarded contract will be subject to Section 508 compliance. Section 508 of the

Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal

Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing

Section 508 can be found at http://www.section508.gov. The third applicable regulation is the

HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable

Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities.

All contractors (including subcontractors 1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005):

http://www.hhs.gov/od/Final_Section_508_Policy.html

HHS Section 508 Web site: http://508.hhs.gov/

HHS ASPA Web Communications Division Web site:

http://www.hhs.gov/web/policies/index.html

US General Services Administration (GSA) Section 508 Web site:

http://www.section508.gov/index.cfm

18.0 PAPERWORK REDUCTION ACT COMPLIANCE

(a) If the successful bidder’s solution involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; the Paperwork

Reduction Act of 1995 (44 U.S.C 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer’s Representative shall be guided by the provisions of 5 CFR Part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance

Officer to determine the procedures for acquiring OMB clearance.

(b) The Contractor shall not expend any funds or begin any data collection until OMB Clearance is received. Once OMB Clearance is received from the Contracting Officer’s Representative, the

Contracting Officer shall provide the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 150 days for

OMB clearance. The Contracting Officer will consider excessive delays caused by the

Government, which arise out of causes beyond the control and without the fault or of the

Contractor.

19.0 KEY PERSONNEL

Certain skilled, experienced, professional, and/or technical personnel are essential for successful accomplishment of the work to be performed under this order. These are defined as “Key

Personnel” and are those persons whose resumes are to be submitted as part of the Contractor’s quotation. The following personnel have been designated as Key personnel for this order:

6.1.1.1.1 Project Manager

The Contractor agrees to use the key personnel during the performance of the resultant award and shall not remove them from the contract work, replace them, or supplement them with additional personnel, unless authorized in accordance with the following provisions:

a. The Contractor shall not substitute key personnel assigned to perform work under

This contract without prior approval of the CO. Requests for approval of substitutions shall be in writing and shall provide a detailed explanation of the circumstances necessitating the proposed substitution(s). Requests must contain a complete resume for the proposed substitute, and any other information as requested by the Contracting Officer. Proposed substitutions must have qualifications that are equal to or higher than the key personnel being augmented. The

Contracting Officer or his authorized representative shall evaluate such requests and promptly notify the Contractor in writing whether the proposed substitution is acceptable.

b. If the Contracting Officer determines that: (1) suitable and timely replacement of key personnel who are to be or have been reassigned, terminated, or have otherwise become unavailable for the contract work is not reasonable forthcoming, or (2) the resultant substitution would be so substantial as to impair the successful completion of the contract in accordance with the proposal accepted by the Government at the time of contract award, the Contracting Officer may (I) terminate the contract for cause or for the convenience of the Government, in whole or in part, as appropriate, or (ii) in his discretion, if he finds the Contractor a fault for the condition, equitably adjust the order price downward to compensate the Government for any resultant delay, loss, or damage.

c. These provisions shall be fully applicable to any subcontract and incorporated into subcontracts.

20.0 CONTRACTOR IDENTIFICATION

Contractor personnel when attending meetings, sending emails, or participating on telephone calls shall identify themselves as contractor personnel. Identification in meetings and on telecom shall be at the beginning of the call or meeting to allow government personnel to excuse contractors if appropriate. Contractor personnel shall identify themselves with their company name in the signature block of emails.

21.0 SECURITY REQUIREMENTS

All contractors, consultants, and experts are required to have a suitability determination conducted. If the contractor, consultant, or expert (regardless if the person is individually represented or a corporately represented) requires access to national security information in performing work for HHS, he, or she must:

• Follow the National Industrial Security Program Operating Manual [PDF - 1.2MB] (NISPOM) guidance.

22.0 GOVERNMENT POINTS OF CONTACT

TBD, Contracting Officer

200 C Street, SW

Washington, DC 20024

Email: TBD at Contract Award

TBD, Contracting Officer Representative

Department of Health and Human Services

200 C Street, SW

Email: TBD at Contract Award

23.0 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY

(January 2008)

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the

Workforce Investment Act of 1998, all electronic and information technology (EIT) products and services developed, acquired, maintained, and/or used under this contract/order must comply with the

"Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and

Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part

1194. Information about Section 508 provisions is available at http://www.section508.gov The complete text of Section 508 Final provisions can be accessed at http://www.access-board.gov/sec508/508standards.htm.

The Section 508 standards applicable to this contract/order are identified in the Performance Work

Statement. The contractor must provide a written Section 508 conformance certification due at the end of each order/contract exceeding $100,000 when the order/contract duration is one year or less. If it is determined by the Government that EIT products and services provided by the Contractor do not conform to the described accessibility in the Product Assessment Template, remediation of the products and/or services to the level of conformance specified in the vendor's Product Assessment

Template will be the responsibility of the Contractor at its own expense.

In the event of a modification(s) to the contract/order, which adds new EIT products and services or revised the type of, or specifications for, products and services the Contractor is to provide, including

EIT deliverables such as electronic documents and reports, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template to assist the

Government in determining that the EIT products and services support Section 508 accessibility requirements. Instructions for documenting accessibility via the HHS Section 508 Product

Assessment Template may be found at http://508.hhs.gov. [(End of HHSAR 352.270-19(b)]

Prior to the Contracting Officer exercising an option for a subsequent performance period/additional quantity or adding increment funding for a subsequent performance period under this contract, as applicable, the Contractor must provide a Section 508 Annual Report to the Contracting Officer and

Contracting Officer's Technical Representative (also known as Project Officer or Contracting

Officer's Representative). Unless otherwise directed by the Contracting Officer in writing, the

Contractor shall provide the cited report in accordance with the following schedule. Instructions for completing the report are available at: http://508.hhs.gov/ under the heading Vendor Information and

Documents.

The Contractor's failure to submit a timely and properly completed report may jeopardize the

Contracting Officer's exercising an option or adding incremental funding, as applicable.

Schedule for Contractor Submission of Section 508 Annual Report: "To be determined at time of award" [End of HHSAR 352.270-19(c)]

24.0 CONTRACT CLAUSES

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.

http://www.access-board.gov/sec508/508standards.htm http://www.access-board.gov/sec508/508standards.htm

1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES

Full text of the FAR clauses may be accessed electronically at:

https://www.acquisition.gov/far/index.html Reg Clause Date Clause Title

FAR 52.202-1 Nov 2013 Definitions

FAR 52.203-2 Apr 1985 Certificate of Independent Price Determination

FAR 52.203-3 Apr 1984 Gratuities

FAR 52.203-11 Sept 2007 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions

FAR 52.203-12 Oct 2010 Limitation on Payments to Influence Certain Federal Transactions

FAR 52.203-14 Oct 2015 Display of Hotline Poster(s)

FAR 52.203-17 Apr 2014 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

FAR 52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber ContentPaper

FAR 52.204-7 Jul 2013 System for Award Management

FAR 52.204-8 Apr 2016 Annual Representations and Certifications

FAR 52.204-12 Dec 2012 Data Universal Numbering System Number Maintenance

FAR 52.204-13 Jul 2013 System for Award Management Maintenance

FAR 52.204-18 Jul 2015 Commercial and Government Entity Code Maintenance

FAR 52.209-10 Nov 2015 Prohibition on Contracting with Inverted Domestic Corporations

FAR 52.210-1 Apr 2011 Market Research

FAR 52.215-2 Oct 2010 Audits and Records – Negotiation

FAR 52.215-19 Oct 1997 Notification of Ownership Changes

FAR 52.219-25 Apr 2008 Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting.

FAR 52.222-38 Feb 2016 Compliance with Veterans’ Employment Reporting Requirements

FAR 52.223-6 May 2001 Drug-Free Workplace

FAR 52.225-25 Oct 2015 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

FAR 52.226-1 Jun 2000 Utilization of Indian Organizations and Indian-Owned Economic Enterprises.

FAR 52.227-1 Dec 2007 Authorization and Consent, Alternate 1 (APR 1984)

FAR 52.227-2 Dec 2007 Notice and Assistance Regarding Patent and Copyright Infringement

FAR 52.227-3 Apr 1984 Patent Indemnity

FAR 52.227-16 June 1987 Additional Data Requirements

FAR 52.227-17 Dec 2007 Rights in Data Special Works

FAR 52.229-3 Feb 2013 Federal, State and Local Taxes

FAR 52.232-1 Apr 1984 Payments

FAR 52.232-9 Apr 1984 Limitation on Withholding of Payments

FAR 52.232-11 Apr 1984 Extras

FAR 52.232-17 May 2014 Interest

FAR 52.232-18 Apr 1984 Availability of Funds

FAR 52.232-20 Apr 1984 Limitation of Cost

FAR 52.232-23 May 2014 Assignment of Claims

FAR 52.232-25 Jul 2013 Prompt Payment

FAR 52.233-1 May 2014 Disputes

FAR 52.233-3 Aug 1996 Protest After Award

FAR 52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim

FAR 52.242-1 Apr 1984 Notice of Intent to Disallow Costs

FAR 52.242-3 May 2014 Penalties for Unallowable Costs

FAR 52.242-4 Jan 1997 Certification of Final Indirect Costs

FAR 52.242-13 Jul 1995 Bankruptcy

FAR 52.243-1 Aug 1987 Changes - Fixed-Price Alternate V (Apr 1984).

FAR 52.243-6 Apr 1984 Change Order Accounting.

https://www.acquisition.gov/far/index.html

FAR 52.243-7 Apr 1984 Notification of Changes

FAR 52.244-2 Oct 2010 Subcontracts, Alternate 1 (Jun 2007)

FAR 52.244-5 Dec 1996 Competition in Subcontracting

FAR 52.244-6 Feb 2016 Subcontracts for Commercial Items

FAR 52.245-1 Apr 2012 Government Property

FAR 52.245-9 Apr 2012 Use and Charges

FAR 52.246-23 Feb 1997 Limitation of Liability.

FAR 52.246-25 Feb 1997 Limitation of Liability—Services

FAR 52.249-2 Apr 2012 Termination for the Convenience of the Government (Fixed-Price)

FAR 52.249-8 Apr 1984 Default (Fixed-Price Supply and Service)

FAR 52.249-14 Apr 1984 Excusable Delays

FAR 52.253-1 Jan 1991 Computer Generated Forms

2. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION

REGULATION (HHSAR) (48 CFR Chapter 3) CLAUSES

Full text of the HHSAR clauses can be found at http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

HHSAR 352.201-70 Dec 2015 Paperwork Reduction Act

HHSAR 352.202-1 Jan 2006 Definitions - with Alternate paragraph (h)

HHSAR 352.203-70 Dec 2015 Anti-Lobbying

HHSAR 352.215-70 Dec 2015 Late Proposals and Revisions

HHSAR 352.222-70 Dec 2015 Contractor Cooperation in Equal Employment Opportunity Investigations

HHSAR 352.223-70 Dec 2015 Safety and Health

HHSAR 352.224-70 Dec 2015 Privacy Act

HHSAR 352.227-70 Dec 2015 Publications and Publicity

HHSAR 352.228-7 Dec 1991 Insurance - Liability to Third Persons

HHSAR 352.231-71 Jan 2001 Pricing of Adjustments

HHSAR 352.233-71 Dec 2015 Litigation and Claims

HHSAR 352.242-73 Jan 2006 Withholding of Contract Payments

HHSAR 352.242-74 Apr 1984 Final Decisions on Audit Findings

3. ADDITIONAL CONTRACT CLAUSES

3.1. Additional HHS Acquisition Regulation (HHSAR) Clauses – In Full Text

352.231-70 Salary rate limitation (December 2015)

(a) The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated.

(b) For purposes of the salary rate limitation, the terms ‘‘direct salary,’’ ‘‘salary,’’ and ‘‘institutional base salary’’ have the same meaning and are collectively referred to as ‘‘direct salary’’ in this clause.

An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs). (NOTE: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with federal funds.)

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(c) The salary rate limitation also applies to individuals under subcontracts.

(d) If this is a multiple-year contract or order, it may be subject to unilateral modification by the

Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund the resulting contract.

(e) See the salaries and wages pay tables on the U.S. Office of Personnel Management website for

Federal Executive Schedule salary levels.

(End of clause)

3.2. Additional Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses – In Full

Text

52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters (Jul

2013)

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity

Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the Central Contractor Registration database via https://www.acquisition.gov.

(b) As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments—

(1) The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by—

(i) Government personnel and authorized users…