RFTOP.JX.doc

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

CENTERS FOR DISEASE CONTROL AND PREVENTION

National Center for Emerging Zoonotic and Infectious Diseases

ATLANTA, GEORGIA

PART 1 - REQUEST FOR TASK ORDER (TO) PROPOSALS

1. Point of Contact Name Linda Williams Email: lwilliams6@cdc.gov

Phone: 770-488-2692 Mailing Address:

CDC/PGO

Linda Williams, Contract Specialist 2920 Brandywine Road, Room 3626

Atlanta, GA 30341-5539

2. Proposed Period of Performance: Work shall begin from date of award of the order and shall continue for a period of 12 months.

3. Severability: Non severable

4. Proposal Instructions: Proposals are to be submitted via email to Linda Williams, lwilliams6@cdc.gov by XXX EST on __________.

Questions are also to be submitted via email to Linda Williams, lwilliams6@cdc.gov by COB ___________.

5. Contract reference: This Request for Task Order Proposal is consistent with the purposes for which the Healthcare Epidemiology and Infection Control contract was awarded. .

6. Page Suggestion: The Contractor shall limit the proposal for this task order to [25] single-spaced pages of text for the technical proposal; the page limit does not include appendices, resumes, or the budget spreadsheets. The narrative plan shall include a general approach, a staffing and management plan, organization chart and key deadline dates.

7. Price proposal format suggestion: The budget shall be included as an appendix as an Excel spreadsheet, with an itemized budget per task, including itemized budgets for any subcontracted work. Budgets, staff hours, and other direct costs for this task order request shall be organized around the tasks and related deliverables described herein. Budgets for any additional or alternative proposals by the contractor shall be presented as optional budget spreadsheets. For tasks with multiple deliverables CDC requests the contractor to provide budgets for each major activity.

PART II – DESCRIPTION OF WORK

1. Identification Section:

a. RFTOP Descriptive Title: [_Harnessing Electronic Health Records to Enhance Reporting to the Vaccine Adverse Events Reporting System (VAERS)_]

b. RFTOP No.: [________________]

c. Functional Domain:

FORMCHECKBOX

1 - Research Implementation

FORMCHECKBOX

2 - Research Development

FORMCHECKBOX

3 - Evaluation

FORMCHECKBOX

4 - Project Support Services

STATEMENT OF WORK

Background and Need In April 2009, CDC began responding to cases of influenza type A H1N1 virus. Within approximately two months, the World Health Organization raised the worldwide pandemic alert level to Phase 6 in response to the ongoing global spread of the virus, indicating a global pandemic was underway. To prevent morbidity and mortality from H1N1 influenza, monovalent H1N1 influenza vaccines were developed, manufactured, and used during the 2009-2010 influenza season. The 2009 H1N1 antigen will be included in trivalent seasonal vaccine for the 2010-2011 season.

VAERS is a passive reporting system that may be used by medical personnel, patients and families, or the manufacturer to report adverse events possibly associated with vaccines. VAERS has been instrumental in detecting possible vaccine safety problems, but underreporting of adverse events is a limitation of the system. By statute, VAERS reports are considered serious if they result in death, hospitalization, prolongation of hospitalization, permanent disability, congenital anomaly or if the individual filing the report considered the adverse event(s) to be life threatening. VAERS staff routinely contacts clinicians or hospital to obtain medical record summaries to learn about additional information on the clinical features and/or severity of the adverse event for reports classified as serious and for selected other reports.

Monitoring vaccine safety is an important part of CDC’s mission and the national vaccination program. In 2009, the National Vaccine Advisory Committee (NVAC) recommended that CDC’s Immunization Safety Office (ISO) “identify and evaluate ways to (1) increase the number of serious events reported to VAERS; and (2) improve the quality and completeness of reports received.” This recommendation could more readily be accomplished by initiating reports from electronic health records. A prototype system has been developed through a Vaccine Safety Datalink (VSD) project. The system flags potential adverse events when an appropriate diagnosis is entered within a specified time interval after a vaccination, prompting the clinician to determine whether a VAERS report is justified, facilitating reporting of the information. This system was successfully pilot tested but is not currently being used. Subsequently this system was linked in a non-vaccine safety project, to the Electronic Medical Record Support for Public health (ESP) project, which uses electronic health records to facilitate reportable disease surveillance.

Objectives The purpose of this project is to develop and pilot test computer software to improve electronic reporting of potential vaccine-related adverse events to the VAERS system. The primary hypothesis is that electronic reporting of potential vaccine-related adverse events to the VAERS system will increase reporting by a factor of ≥3. A secondary hypothesis is that computer-prompted electronic reporting to VAERS from electronic health records will be acceptable to a majority of clinicians.

Scope of Work The purpose of this procurement is to improve reporting to VAERS using data from electronic health records.

Specific Aims:

1. The contractor will identify or create software that can interface with electronic health records, identify adverse events following vaccination, allow the physician to determine whether the event should be reported, and transmit the data electronically.

2. The contractor will identify 2 study sites that use electronic health records, install and test the software at these sites, and then pilot test the system for 4-6 months.

3. The contractor will deliver a report summarizing the experience, including statistics such as the numbers of patients treated by the study sites, the number of patient visits during the study period, the number of potential adverse events following vaccination identified electronically, and the number transmitted.

General Information Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and associated healthcare facilities as required.

Type of Contract: The government will award a cost plus task order, costs as indicated at the end of this SOW.

Contractor Travel: Not Applicable.

Data Rights (If applicable): The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

Confidentiality of Information: Work on this project may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

Section 508: Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) 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.

Regardless of format, all Web content or communications materials produced for publication on or delivery via CDC 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 subcontractors1) or consultants responsible for preparing or posting content intended for use on an CDC-funded or CDC-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. Checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

36 CFR 1194.21 (for software and programmatic elements in websites), 36 CFR 1194.22 (for documents and websites), and 36 CFR 1194.24 (for video and multimedia content) 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 1 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.

Government Furnished Property, Equipment, and Services None Tasks The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract.

The Government and the Contractor understand and agree that the services under this order are non-personal services and the parties recognize and agree that no employer-employee relationship exists or will exist under the contract between the Government and the Contractor employees.

In order for the Contractor to accomplish the work under this order, it shall be necessary for the Contractor to complete the following tasks:

Task 1: Recruitment Recruit at least 2 study sites (i.e., managed care organization or group practices that use electronic health records and track vaccine receipt) with a total enrolment of ≥ 330,000 (for the 2 sites combined).

Task 2: Creation Platform Create or modify an existing software platform for stimulated VAERS reporting. The platform should include algorithms for identifying patient care visits that may represent adverse events following immunization. Some of these algorithms will include adverse events listed in the VAERS Table of Reportable Events Following vaccination (http://vaers.hhs.gov/resources/VAERS_RET.pdf) as well as those conditions that are contraindications for vaccination as indicated in the vaccine insert; federal law mandates that healthcare providers report these events. Stimulated reporting may include reports that are sent automatically by the software; or reports that are initiated by the software but routed to a physician for confirmation before being sent.

Task 3: Coordination and Monitoring of Data Collection The contractor will compare the proportion of VAERS reports with and without prompted electronic reporting. The national proportion of VAERS reports per vaccine dose will be estimated from national figures and it will be estimated by taking the number of VAERS reports and divide them by the national total of vaccine doses administered. The number of VAERS reports was 28,494 in 2007, 29,983 in 2008, and increased to 32,878 in 2009. The national total of vaccine doses administered will be estimated using data from various available sources. The national proportion of VAERS reports per vaccine dose (not using prompted electronic reporting) will be compared with the proportion of VAERS reports per vaccine dose (using prompted electronic reporting) given at study sites. The national proportion of VAERS will not include the VAERS reports submitted by the study sites nor the number of doses of vaccine administered at the sites.

Task 4: Data Analysis The contractor will conduct additional analysis to characterize the types of symptoms reported and will assess whether the prompted reporting results in a change in the proportion of serious reports.

Task 5: Assessment of Software Adapt the software as needed so that it can interface with the electronic health records to identify adverse events following vaccination at the study sites; automatically notify the clinician if a vaccination had taken place, allow the clinician to determine whether a VAERS report is appropriate; and send an electronic message in standard format to the VAERS system. The system will include adverse events listed on the vaccine injury compensation table, conditions that are contraindications for vaccination, and adverse events that are required to be reported as described above.

Task 6: Pilot Testing The data elements to be transmitted include those on the VAERS report form (e.g., patient age and sex, the date of vaccination, the type of vaccine(s) given, the date of onset of symptoms, and the specific symptoms that prompted the report).

Install, test, modify, and retest the software at the study sites Pilot test the software for 4-6 months at the study sites.

Task 7: Evaluation & Final Report Determine and report to the government the acceptability of the software to clinicians. This may be accomplished via a questionnaire or other appropriate means.

Determine and report the number of patients covered by the study sites, the number of patient visits, the number of vaccinations administered, the number of adverse events identified by the software, and the number of ESP-prompted VAERS reports during the study period.

Deliverables Summary Table The following deliverables shall be provided to the Project Officer and relevant CDC staff no later than the dates specified below:

The Contractor shall support a computerized system that identifies adverse events following immunization and creates electronic reports for transmittal to VAERS. The Contractor shall follow standard information technology best practices for system development. This includes project managers for oversight, reporting, and the establishment of strict project control processes to ensure mitigation of risks, minimal schedule variance, and adherence to a budget for system development. Deliverable review and approval schedules will be established by the CDC for each phase of this project.

The contractor shall bring problems or potential problems affecting performance to the attention of the Contracting Officer and Contracting Officer Technical Representative (COTR) as soon as possible. Verbal reports shall be followed up with written.

Human Subjects Protection This project will seek Human Subjects protections as appropriate at each study conducted through this SOW.

Reports and Deliverable Schedule

1 to CO At the end of each quarter

1 to CO Four, eight and twelve months from start of contract award

TECHNICAL EVALUATION CRITERIA

Award: This Task Order will be awarded to the Offeror whose proposal is considered to be the most advantageous to the Government, price and other factors (identified below) considered. For purposes of this evaluation; technical factors, (methodology/approach, staffing/management and experience) are more important in making the award determination. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

Technical Evaluation: Technical proposals will be evaluated according to the criteria set forth below:

Points or relative Criteria

Value of Criteria

Corporate Experience & Capacity

Technical Approach & Program Management

Personnel Staffing and Utilization

TOTAL SCORE

A. Corporate Experience and Capacity: (35 points) The Government will evaluate the capacity and demonstrated experience of the offeror’s proposal, corporate experience, and proposed staffing and methodology for undertaking the project for each of the above elements. The Government will evaluate the offeror’s qualifications to collect, manage, transmit, and maintain the security and confidentiality of data collected.

B. Technical Approach and Program Management Plan: ( 35 points) The Government will evaluate the soundness, practicality and feasibility of the offeror’s proposed approach and organizational and management plan and methodology for undertaking the project and meeting each of the above objectives.

C. Personnel staffing and utilization: (30 points) The Government will evaluate the soundness and feasibility of the offeror’s proposed personnel management plan for accomplishing the work expectations of the Statement of Work. This shall address each of the above objectives, and shall include: Staffing plan and proposed personnel, and resumes and/or Curriculum Vitae of current and proposed employees who will be used under this contract, including education and background experience; Person hours and percentage of time for each key individual; Delineation of staff authorities and lines of responsibility;

D. Cost Evaluation: (Not scored) A cost analysis of the business cost proposal shall be conducted to determine the reasonableness of the proposal.