APHL NewSTEPs | Data Repository and Website RFI
Request for Information (RFI)
NewSTEPs (Newborn Screening Technical assistance and Evaluation Program) Data Repository and Website
Issued October 9, 2012
Responses due by November 1, 2012
ASSOCIATION OF PUBLIC HEALTH LABORATORIES
8515 GEORGIA AVENUE, SUITE 700
SILVER SPRING, MD 20910
PHONE: 240.485.2745
TABLE OF CONTENTS
1. GENERAL INFORMATION
1.1 Background
1.2 Project Components
2. PREPARING AND SUBMITTING A RESPONSE
2.1 Response Submittal
2.2 Timeline
2.3 Contact
3. EXPECTATIONS FOR CHOSEN APPLICANT
4. GENERAL REQUIREMENTS FOR RFI
4.1 Submitter Contact Information
4.2 Executive Summary
4.3 Organization/Management Capabilities and Financial Stability
4.4 References
4.5 Examples of Successful Implementation
4.6 Staff Qualifications
4.7 Project Timeline
4.8 Budget
5. FUNCTIONAL REQUIREMENTS FOR RFI
5.1 Scope
5.2 Project Details and Specifications
6. EVALUATION CRITERIA
7. DISCLAIMER
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1. GENERAL INFORMATION
1.1 Background
Newborn screening (NBS) is a baby’s first exposure to public health and is a public health program that entails many components including testing, diagnosis, follow-up, treatment, education and evaluation. In the United States, 4.5 million newborns receive newborn screening annually. The Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) evaluates and recommends disorders to be included on the Recommended Uniform Screening Panel, (RUSP), however each state mandates the specific disorders to be tested, implements a screening process including follow-up of out-of-range results, and is responsible for quality improvement of the entire newborn screening system.
The Association of Public Health Laboratories (APHL) has received funding through a five-year cooperative agreement with the Health Resources and Services Administration (HRSA) Genetic Services Branch to design, develop and implement the Newborn Screening Technical Assistance and Data Repository Program (NewSTEPs). This program will provide two distinct functions, 1) a newborn screening (NBS) data repository and 2) an interactive website for sharing resources and educational material. NewSTEPs will provide tools to state newborn screening programs to ensure that states can adequately evaluate, analyze, and benchmark the performance of their tests and the quality of their newborn screening programs. The purpose of NewSTEPs is to expand on previous quality improvement efforts and strengthen existing newborn and genetics screening programs by gathering and providing data as well as offering technical and educational resources to various NBS stakeholders. The project will entail facilitating the harmonization of newborn screening activities through innovation and technology with the goal of being able to analyze, compare and continuously improve newborn screening systems.
NewSTEPs will address the challenges faced by state NBS programs by providing training, technical assistance, and a data repository for evaluation and assessment of NBS performance. Activities include information gathering and analysis (formative analysis) to determine the needs of the state NBS programs in education, communication and data analysis; evaluating definitions for key NBS outcomes and data components; and seeking input from state NBS personnel. The new data repository will be developed after a careful and thorough assessment of the NBS community’s goals and expectations.
About APHL: APHL is a non-profit, 501(c)3 organization that works to safeguard the public’s health by strengthening public health laboratories in the United States and globally. The Association’s members include state and local laboratories, state environmental and agricultural laboratories, and other government laboratories that conduct testing of public health significance. To obtain more information about APHL, please visit http://www.aphl.org.
1.2 Project Components
NewSTEPs Website: The NewSTEPs team plans to foster communication through tools on our new website including electronic bulletin boards where NBS personnel can discuss emerging trends, current challenges, and frequently asked questions. The NewSTEPs website will contain educational resources, archived webinars and links to other newborn screening sites (e.g., BabysFirstTest.org). The website should be easy to navigate and information should be presented and categorized in a logical manner. The website will contain a monthly “Hot Topics in Newborn Screening” section and groups will be encouraged to submit highlights from recent projects.
The website and series of community-oriented online tools will be developed to facilitate communication, and provide a forum for education and information sharing. The website will be extensible, user friendly and easily navigated, with identifiable sections for all key stakeholder groups. One person on the NewSTEPs staff will be designated to make changes to the website. The website will also be linked to the NBS data repository system. The website will have the following clearly delineated sections.
NBS Laboratory, Follow-Up, and Medical Personnel
o Webinars for NBS systems training
o Training information and manuals for the online repository
o NBS calendar of events (e.g., meetings, symposia, training workshops, etc.)
o Links external websites (e.g., Regional Collaboratives, NCC, AAP, CDC, NBS Clearinghouse, etc.)
o Recent news
Parents and Caregivers
o Broad overview of NBS systems and state programs
o State level information (e.g., # of babies screened, contacts, links to state programs)
o Links to other NBS and educational resources (www.Babysfirsttest.org), March of Dimes, disease and disorder specific websites
Public Health Decision Makers
o Overview of screening programs catered to this group
o Policy issues
APHL envisions the design of this website to have similar features to the Child and Adolescent Health and Measurement Initiative (CAHMI data) resource center (www.childhealthdata.org). The CAHMI data resource center is funded by HRSA-MCHB and houses an abundance of data related to children’s health (e.g., children with special needs, medical data) and survey data. The website allows for state rankings among the quality indicators and stratification based on demographics and other factors. NewSTEPs team will explore integrating some of the same functions. APHL requires that the website be designed, developed, and in production within the first year from project start date.
NBS Data Repository System: A repository will be designed to house data on infants identified by NBS for all disorders identified by the recommended uniform screening panel (RUSP) as well as program specific data. Additionally, the repository will need to be extensible to other disorders that are not yet on the RUSP and their corresponding screening tests. One of the goals of the data repository is to allow NBS programs to track their own activity over time (by month or year) and to compare data from their program to aggregated data from states across the country. State NBS programs should be able to view their dataand also be able to quickly view means, ranges, etc. for specific variables.
Each state program will have numerous variables and data points stored in the data repository. Examples of variables that will be collected and reported includes: prevalence of the disorder, time to follow-up of the affected babies, test performance (sensitivity, specificity), and number of babies lost to follow-up. Additionally, a state profile for newborn screening programs will be incorporated into the repository and will include information on staffing, equipment, cutoffs, assay methodologies, and fees. Finally, a separate module will be created to transfer laboratory test data from the newborn screening laboratory information management systems to allow evaluation of assays and test differences across state programs, pairing programs with other laboratories that use similar methodologies and metrics.
Current efforts of the NewSTEPs staff include engaging other organizations involved in NBS data collection, management, and information dissemination. We are coordinating efforts of these groups to develop data standards and definitions, with the goal of consistent reporting into the data repository system. Final requirements for the data repository system will be developed 4th quarter 2012. NewSTEPs staff will engage stakeholders in focus groups and surveys to gather input about current gaps and needs for the data repository system. NewSTEPs will include various stakeholders in these discussions and develop activities to link agencies.
We are also seeking input from the newborn screening LIMS vendors. This is to ensure that the data repository variables and data points can be mined from the state LIMS and electronically transferred to the new data repository. Data transfers should be controlled by the states, allowing for state approval of data prior to upload into the NewSTEPs repository. States should also have the capability to enter data manually through a web form. The repository will provide an online data dictionary and ‘Help’ module that is periodically updated as new technology, terminology, and content changes.
The NewSTEPs repository will also have the capability to provide reports for state newborn screening programs. The application should be interactive and allow data queries to be easily run by the end user, and provide standard query templates to facilitate data retrieval. Reports will be available to display longitudinal trends over time for each metric, along with individual state data compared to other states in aggregate. Ad hoc reporting tools will provide state programs the ability to query their own data, and other stakeholders to query aggregate data.
2. PREPARING AND SUBMITTING A RESPONSE
2.1 Response Submittal
Responses must be submitted by 5:00 pm EST, on November 1, 2012. Responses can be sent by the following methods: via email to newsteps@aphl.org or by US MAIL, Commercial delivery service or hand delivery to Jelili Ojodu MPH, APHL, 8515 Georgia Avenue Suite 700, Silver Spring, MD, 20910.
Email attachment is the preferred means of receipt. Regardless of delivery method used, all responses must be received at the APHL office by 5:00 pm EST on November 1, 2012. It is the responsibility of the applicant to ensure that the response is received at APHL by this deadline.
Responses should be limited to 15 pages of text and include information contained in Sections 4 and 5 of this RFI. References, charts and graphics are not included as part of the page limit.
Submitters will receive a confirmation of receipt of their response by APHL. APHL may terminate or modify the RFI process at any time during the response period. All changes to the RFI will be posted to the APHL Website. No changes will be made to the RFI within one week of due date. Responses that are not received by the stated deadline shall be determined to be non-responsive and at APHL’s discretion may not be considered in the review of respondents.
2.2 Timeline
Applications are due by 5:00 pm EST on November 1, 2012 and will be evaluated. APHL may request meetings or a teleconference with the respondents prior to announcement of a Request for Proposals (RFP).
A contract will not be awarded based upon this RFI. A separate RFP will be announced that will result in a final contract.
2.3 Contact
All questions and responses to the RFI should be submitted to Mr. Jelili Ojodu, MPH, Director, Newborn Screening and Genetics at jelili.ojodu@aphl.org.
3. EXPECTATIONS FOR CHOSEN APPLICANT
The chosen applicant will be expected to:
1. Develop the technical requirements of the website and data repository system in collaboration with the NewSTEPs team.
2. Create an interactive website with tools and resources for sharing information, posting questions and announcements, calendar of events, etc. Different levels of security based on user roles should be incorporated into the design to account for different access permissions.
3. Develop the NBS data repository (including the database) and the web interface that interacts with the repository. Different levels of security based on user roles should be incorporated into the design to account for different access permissions.
4. Both the interactive website and the web interface to the data repository must meet web standards and be browser independent; must not require any plug-ins so it will work on every platform; must be HTML5 compliant.
5. Complete both the interactive website and the data repository by May 1, 2013. A final product must be completed by September 30, 2013.
4. GENERAL REQUIREMENTS FOR RFI
In this section the respondent will discuss the capabilities, resources, and expertise of his/her
organization in accomplishing the tasks described in Section 1.2. The following sections should be
included in your application.
4.1 Submitter Contact Information
The application must contain the full legal name and signature of the authorized representative of the contractor. Telephone, fax, email and organization address of the point of contact person needs to be included.
4.2 Executive Summary
The respondent must provide an executive summary of the application being submitted. The summary should identify the design, development and services that are being offered in the application. Limit the executive summary to 300 words or less.
4.3 Organization/Management Capabilities and Financial Stability
The respondent must describe his/her company’s organizational structure and provide a brief history of the organization. Include an organizational chart.
4.4 References
The respondent must include a list of at least 3 clients, organizations or institutions that can be used as references. These references should be capable of verifying information supplied by the respondent in the application. For each reference include:
• Organization Name
• Address
• Contact person name, email, phone number and address
At least one reference should be from an organization where a similar project was developed. References may be contacted to determine the quality of work performed, competency of personnel assigned to the project, etc. The results of the reference checks will be provided to the evaluation and may be used in scoring the written application.
4.5 Examples of Successful Implementation
The respondent must include a description of his/her organization’s relevant experience developing and implementing web based data repositories. Please provide information about specific platforms used including database, operating system, programming language(s), dates implemented, and customer satisfaction. Testimonials are encouraged.
4.6 Staff Qualifications
The respondent must provide a project team organizational chart, followed by resumes/CVs of key personnel that will be assigned to the system development and implementation. All key personnel must be employed by the respondent or be identified as a subcontractor. Include roles, responsibilities and estimated time allocated for each key personnel.
4.7 Project Timeline
The respondent must provide details regarding a timeline and methodology for designing the website and data repository system, including deliverables and milestones to support the development.
Please describe how you would do the following:
i. Year 1 – Development
ii. Year 2 – Additional Enhancements
iii. Year 3-5: Maintenance
4.8 Budget
A draft budget should be presented for all phases of this project including development and maintenance. The respondent must provide a cost application to accomplish the scope of work. The budget must encompass all design, production, and software acquisitions necessary for the development and maintenance of the website and data repository. Please include any costs associated with additional maintenance, support, upgrades and long-term annual maintenance. This draft budget is not binding but will provide information to NewSTEPs for project development.
5. FUNCTIONAL REQUIREMENTS FOR RFI
In this Section, the respondent must discuss project details and provide a description of how his/her organization will implement the project specifications listed in Section 5.2. The application must include a technology solution that allows APHL members and staff to easily and cost effectively search and update content after implementation. The inclusion of programs, tools, and novel technologies will enhance your application. The following sections should be included in your application.
5.1 Scope
The respondent must discuss the scope of the project with regards to developing an interactive website and data repository for newborn screening data.
5.2 Project Details and Specifications
The application must describe how the project will meet the description in Section 1.2.
The respondent must also include information specifically as it relates to the following specifications.
Website Structure Specifications: The application for the NewSTEPs website must describe how his/her organization will meet following specifications:
• Community-oriented online tools to facilitate communication.
• Identifiable sections (below) for key stakeholders such as newborn screening laboratories, follow-up programs, public health decision makers, federal partners in newborn screening.
Ø Hosting and archiving webinars for NBS systems training
Ø Training information and manuals for the online repository
Ø NBS calendar of events (e.g., meetings, symposia, training workshops, etc.)
Ø Links to external websites (e.g., HRSA funded Regional Collaboratives, National Coordinating Center for the Regional Collaboratives, American Academy of Pediatrics, , Centers for Disease Control and Prevention, NBS Clearinghouse, etc.)
• State rankings among the quality indicators and stratification based on demographics and other factors.
• User friendly and easy to navigate.
• Web application interface to the NBS data repository.
• Similar features as the Child and Adolescent Health and Measurement Initiative (CAHMI data) resource center (www.childhealthdata.org).
Data Repository System Specifications: The application for the NewSTEPs data repository must describe how his/her organization will meet the following specifications.
• Data for all infants identified by NBS for all disorders identified by the recommended uniform screening panel, denominator data from newborn screening programs, and NBS program statistics.
• Data elements: baby level data, denominator data, and NBS program information.
Ø Baby Level Data: Data on each infant with a disorder identified by NBS will be collected. Data will not include baby’s name, but will include an identifier assigned by the NewSTEPs repository with the code held by the NBS program. Minimum data collected will be demographic data (date of birth, state of birth, gender, and race/ethnicity), screen data (date screen performed and date received by lab), and disorder specific data (assay value that triggered the screen, date abnormal result reported, date of diagnosis).
Ø Denominator Data: Denominator data from each state will be required (number of births, number of screens, number of infant deaths before screening, etc). Initially these data will be collected manually by each program; however integration with each state’s department of health vital statistics groups will be pursued to facilitate electronic transfer of the data.
Ø NBS Program Information: Data describing each state’s NBS program, collected on an annual basis to create state program profiles. An in-depth online survey will be requested in the first year to obtain baseline data. In subsequent years, a pre-populated survey will be provided to assist states in completing the data required. Specific data will include: disorders for which the test screens, screening mandates (one vs. two screens, timing, NICU issues), assays, methods, and cutoffs used, laboratory software utilized, and staffing (names of key personnel, new personnel, positions, contact information).
• Standardized and Ad-Hoc Reporting Capabilities: Standardized reporting at both the individual state level and comparative reporting across all participating programs. The ad-hoc reporting system will include the incorporation of a user-friendly reporting tool, allowing raw data export for state programs and fixed reports that may be used by multiple groups. Dynamic reporting system will allow each state to explore their own data to meet local program needs. Examples of reports to be developed include, but are not limited to:
Ø Age at diagnosis
Ø Percent of cards with all essential information
Ø Percent of parental refusal
Ø Percent of eligible infants receiving valid newborn screening test
Ø Percent of unsatisfactory specimens due to improper collection:
Ø Rate of out-of range results and rate of any referral to evaluation
Ø Rate of loss to follow-up
Ø Frequency of condition detected at birth: first screen vs. second screen
Ø Positive predictive value (PPV) of out of-range
Ø Rate of missed cases (false negatives )
Ø Turn-around time distributions: first vs. second screens
Operational Specifications: The application for the NewSTEPs data repository system must describe how his/her organization will meet the following specifications.
• The ability to restrict access to different sections of the system. Ability to restrict access to the data based on user’s profile. Ability to monitor access logs.
• Options for Data Entry and Transfer – to allow data to be entered manually for each individual infant and by electronic transfer of data out of NBS Laboratory Information Systems (LIMS) using a data representation standard, such as XML, or HL7.Beta testing for logical/data processing concerns, aesthetics and usability.
• Ability to use industry terminology [Health Level 7 (HL7), Logical Observation Identifiers, Names and Codes (LOINC) and Systematized Nomenclature of Medicine – Clinical Terms (SNOMED-CT)] within the data upload file.
Please provide mock-ups and visuals to support the project details listed above.
Organizational Infrastructure: The respondent must provide an overview of how his/her organization would be able to respond to the website and the data repository design and administration requests.
Other Specifications: The respondent must include requirements for security. Hosting location and storage/backup details should also be discussed.
6. EVALUATION CRITERIA
Applications will be evaluated based on budget, demonstration of technical understanding of the application, and creativity in the response. APHL will evaluate each application based on the description of the requirements listed in the RFI. The evaluation team will review each applicant and provide recommendations to the NewSTEPs Director.
7. DISCLAIMER
This RFI is neither an agreement nor an offer to enter into an agreement with any respondent. Only selected respondents will have the opportunity to submit formal proposals under the RFP and APHL will conduct a separate evaluation of those proposals. Once that separate evaluation is complete, APHL may then enter a definitive contract with the selected RFP applicant.
The purpose of this RFI is to provide interested parties with information that may be useful to them in making their financial offers pursuant to this RFI. This RFI includes statements, which reflect various assumptions and assessments arrived at by APHL in relation to NewSTEPs and the project. Such assumptions, assessments and statements do not purport to contain all the information that each applicant may require, and may not be complete, accurate, adequate or correct. This RFI may not be appropriate for all persons, and it is not possible for APHL or its employees to consider the programmatic objectives, financial situation and particular needs of each party who reads or uses this RFI.
Information provided in this RFI is on a wide range of matters, some of which may depend upon interpretation of law. The information given is not intended to be an exhaustive account of statutory requirements and should not be regarded as a complete or authoritative statement of law. APHL accepts no responsibility for the accuracy or otherwise for any interpretation or opinion on law expressed in this RFI.
APHL and its employees accept no liability of any nature (whether resulting from negligence or otherwise) arising from reliance of any applicant upon the statements contained in this RFI.
As described in Section 2.1, APHL may in its sole discretion, but without being under any obligation to do so, update, amend or supplement the information, assessment or assumptions contained in this RFI.
The release of this RFI does not imply that APHL is bound to select a pool of respondents or to issue the RFP to the selected respondents and APHL reserves the right to reject all or any of the respondents or applicants for any reason.
Each respondent shall bear its own costs associated with or relating to the preparation and submission of its application. All such costs and expenses will remain with such respondent and APHL will not be liable for these or for any other costs or other expenses incurred by a respondent in preparation or submission of its application, regardless of the conduct or outcome of the response period or the selection process.
