VSD.SampleTaskOrder 1Revised.doc.docx

Attachment J.2

SAMPLE TASK ORDER # 1

SUBJECT TO AVAILABILITY OF FUNDS IN ACCORDANCE WITH FAR 52.232-18

TITLE OF PROJECT: VSD Infrastructure Activities

1. APPLICABILITY

This effort is within the scope of the basic contract discussed in 5.1 of the basic PWS.

2. ORDER TYPE

The effort shall be proposed on a Cost-Plus-Fixed-Fee basis.

3. PERIOD OF PERFORMANCE

The period of performance is from the date of task order award for twelve months.

Contract base year: 9/1/2012 - 8/31/2013 Optional period 1: 9/1/2013- 8/31/2014 Optional period 2: 9/1/2014 - 8/31/2015 Optional period 3: 9/1/2015 - 8/31/2016 Optional period 4: 9/1/2016 - 8/31/2017

4. PLACE OF PERFOMANCE

Services will be performed at contractor’s specified site in the United States.

5. BACKGROUND AND NEED

The Vaccine Safety Datalink has a long history of conducting rigorous vaccine safety research. Participating sites have provided an administrative and data infrastructure in which adverse events following immunization can be evaluated and can support the enhancement and development of vaccine safety methodologies. The administrative aspects of the VSD that have facilitated this project’s success have included not only efficient project management and the creation and participation of working groups, but also active discussions at site visits, annual meetings and conference calls. Utilizing existing data sources at health plans has allowed the VSD to create its own data infrastructure in order to serve as the foundation of the project. It has allowed the VSD to adapt to changing environments and needs. For example, the VSD developed a distributed data model in order to respond to heightened confidentiality concerns and the development of dynamic data files allowed the project to capture near-real time event-based health plan administrative data. As the Government continues the work of the VSD, there is also a need to continue the infrastructure activities for the VSD so that scientifically rigorous and efficient monitoring of vaccine safety can be conducted.

6. PROJECT OBJECTIVE

To conduct both administrative and data management activities that would support the management and development of the work of the VSD. Specific aims surrounding administrative activities would be to manage overall project activities and participate on working groups, site visits, annual meeting, and conference calls. With regards to data management, the objective is to produce and maintain a high quality electronic data infrastructure consisting of health plan members of all ages, located at the contractor’s site, and accessible through a distributed data model. Data will be made available through cycle files, created on an annual basis as well as dynamic data files, created and updated on a more frequent basis (weekly or monthly).

7. SCOPE OF WORK

This task order is for work to be done to support the VSD infrastructure activities. Both administrative and data management work is an ongoing function of the VSD. The administrative functions will involve all program support tasks that support the overall work in the VSD and the main requirements include project management, participation on VSD conference calls, working groups, site visits, and annual meetings. Also included is the management of overall project activities such as study tracking, IRB and data use agreement (DUA) documentation, and the support for external presentation of ongoing VSD work. This task order is also for the creation and maintenance of a high quality electronic data infrastructure. This is an ongoing function of the VSD wherein all work performed uses these data as a resource. The main requirements of this task include data preparation, creation of a distributed data model, creation of a study population, data maintenance and merging of files, and data specifications as outlined in the VSD data dictionary. Data are formatted using SAS vs. 8 (or higher) and are made available through cycle files (created annually) and through dynamic data files (created more frequently, either weekly or monthly). Through this task, a cohort shall be created of all ages from the health’s plan membership base whose entire medical history of health care provider encounters can be accessed electronically.

8. TECHNICAL REQUIREMENTS

Working closely and collaboratively with CDC, the contractor shall accomplish the following:

A. Administrative tasks:

i. The contractor shall participate on the following working groups and associated conference calls:

· VSD project working group

· Adult working group

· Rapid Cycle Analysis working group

· Administrative working group

· Data Management working group

· Methodology working group

· Annual Meeting Working group

· Data Quality working group

· Pregnancy working group

· Principal investigator working group

· Study specific working groups

Each working group will have conference calls up to two times per month.

ii. The contractor shall perform tasks surrounding the general project management of the VSD including study tracking and IRB and DUA documentation.

iii. The contractor shall host up to two site visits per year for the government to discuss work surrounding the VSD.

iv. The contractor shall attend up to 2 meetings per year including the VSD Annual Meeting.

B. Data Preparation:

i. The contractor shall provide sufficient technical information about all data collected to facilitate use by the Government, or indicate any special handling needs beyond the provisions outlined in the Performance work statement.

ii. The contractor shall obtain the necessary clearances to begin automated data compilation. This includes, but not limited to, all IRB approvals and overall contractor approvals for data creation and use for VSD studies and activities.

iii. The contractor shall institute the appropriate means of acquiring the information for each of the automated data files indicated below, if such procedures are not already in place.

C. Creation of a system in which data can be transferred to and from the Government

i. The contractor shall develop and maintain a “distributed data model” (DDM) system that can support VSD activities, such as studies, surveillance, and data management and data quality activities. The DDM allows the contractor to assemble and maintain its computerized data files on a secure server at the site rather than transferring all data files to CDC. Ownership of the data is retained by the contractor and all electronic data are accessed by the Government. The DDM allows all individual level standardized data files to reside at the health plan and should be accessible to the government at a minimum from 5am-midnight EST. The DDM maintains confidentiality of the health plan’s data by utilizing encrypted and secure methods, while limiting access to IRB approved data required for specific studies and data management and data quality checks.

ii. The contractor shall ensure that DDM functions to download SAS programs, transmit emails to the Government, and create and transfer log and output files. Through the DDM, the contractor shall identify Cycle libraries (C20XX), a library housing the DDFs (EVENT), a library housing Medicaid and geocode files (HISTORY), and six permanent libraries for Government use (VSDCDC1-VSDCDC6).

iii. The contractor shall ensure that all requirements of the DDM are met. See attachment 1.

D. Data file Specifications and Creation

i. The contractor shall establish a study population.

(a) The contractor shall identify and establish a study population (i.e. VSD cohort) of all ages whose entire medical history of health care provider encounters is readily accessible electronically, including claims from outside providers. This member population is to be followed over the duration of the contract while enrolled in the participating health plan. This population would be a dynamic cohort in which members may enter or leave the health plan.

(b) Unique identification numbers are to be maintained. To ensure confidentiality and comply with federal regulations, each person within the VSD is assigned a unique randomized VSD identification number that is not linked to their health plan member identification number. Following the structure outlined in the standardized VSD data dictionary (Attachment 2), the unique identification numbers will be found in the CONSTANT files and used as a link between the various VSD files containing demographic and medical services data. Every health plan member in the study population is required to have a record in the CONSTANT file, even if they leave the health plan.

(c) The start date for identifying the VSD Cohort will be the date that an electronic vaccination tracking system became fully operational for the contractor’s health plan. At a minimum, contractors are required to include data from January 1, 2007. The contractor shall include their entire enrolled population at the time the study population is established and on any new entrants into the system, including births.

(d) The contractor shall develop and manage both annual files and dynamic data files. Both follow the current standardized VSD data dictionary, are longitudinal in nature, and contain all records back to the start date of each participating contractor’s VSD cohort. Annual data files are called cycle files and include all data specified in the VSD data dictionary. Cycle files are longitudinal in nature with data through December 31st of the cycle year. This includes member information obtained from administrative files maintained by the individual health plans such as demographic and medical services on all members, age, gender, health plan enrollment, vaccinations, hospitalizations, outpatient clinic visits, emergency department visits, urgent care visits, mortality data, and additional birth information (when available). Dynamic data files permit the ongoing capture of near real-time event based health plan administrative data, including data on vaccination, hospitalizations, emergency department visits, clinical visits, health plan enrollment, and certain demographic characteristics. The following files shall be updated weekly or monthly with new data from the health plan depending on the capabilities of the health plan’s data system: inpatient, outpatient, vaccine, constant, procedure, and enrollment.

(e) The contractor shall create data files as specified in the current standardized VSD data dictionary. The VSD data dictionary is available upon request.

(f) CONSTANT FILE: The contractor shall establish a file that includes basic demographic data that do not change (e.g. birth date, sex, health plan, race) which is derived from membership or enrollment files from the participating health plan. This also includes the VSD ID and is only 1 record per individual. Race/ethnicity data will be included based on the feasibility of collecting such data and the ability of identifying appropriate standardized categories.

(g) ENROLL FILE: The contractor shall establish a means of tracking the data of each health plan member. The contractor shall establish a computerized database component, available to be merged with subsequently described files, which is the ENROLL file, containing the unique VSD identification number, the dates that study eligibility begins and ends, and other specified enrollment characteristics as outlined in the current data dictionary. There shall be separate records for each period that persons are enrolled in the health plan.

(h) GEOCODE FILE: The contractor shall provide a means for geocoding (i.e. based on tract level linkage of residence with Census data) each member of the study population for further socioeconomic characterization. The data that may change (e.g. zip code, etc) in the GEOCODE file on an annual basis.

(i) HMOBIRTH FILE: The contractor shall identify all infants and newborns that were born during the available data years (at a minimum beginning in 2005) in a MCO -owned hospital (or contract hospital) as an MCO-eligible member from birth). The HMOBIRTH FILE will be created for these infants with variables on birth characteristics (which must include birth weight, gestational age, 5 min apgar scores, race and ethnicity, facility ID code, child’s birth state and county, and the mother’s year of birth). If necessary, the sites should link to the state vital records to obtain state birth certificate files in order to populate the variables listed in the HMOBIRTH File.

(j) VACCINE FILE: The contractor shall establish a data file to contain records for all vaccines given to all members in the VSD cohort.

1. The contractor shall include information concerning the administration of all vaccines administered in their population per the data dictionary.

2. The contractor shall include all new vaccines and those that are in routine use in this file, and code the vaccines according to the current data dictionary.

3. The contractor shall include the following variables in this data file: 1) the vaccine received and vaccination date; 2) the manufacturer; 3) lot number; and 4) facility/clinic id code where vaccination was administered. Other variables to be included, if available are: 1) body site and 2) whether the vaccine was given inside or outside the health plan.

(k) INPT and OUTPT Files: The contractor shall establish computerized data files of medical encounters information or alter existing means of recording medical encounters to create such data files, available to be merged with all other study files.

1. The contractor shall include all diagnoses of medical events, using current ICD codes that are made following inpatient admissions for the member population (INPT File).

2. The contractor shall produce an electronic file of medical encounters that occur in an outpatient setting during the period data are collected for the VSD Project (OUTPT file). The file shall include all diagnoses, using ICD codes that were made following an emergency department visit, urgent care, or clinic visit during the study collection period.

(l) MORT and MORTCOD FILE: The contractor shall include a separate electronic data file of all diagnoses, using ICD codes, related to deaths of persons enrolled in the VSD population and related deaths occurring at a minimum of year of an individual member’s termination date as identified in the CONSTANT file. The contractor shall identify deaths from local automated files and provide details of methods for identifying deaths (e.g. hospital discharge data, state death files) and estimates of completeness of ascertainment of deaths in the study population. As some members enrolled in the cohort who die may not receive medical care at their specific MCO, special efforts may be necessary to obtain relevant information from country or state authorities to permit timely evaluation of any potential associations between deaths and vaccinations. The contractor shall describe methods for linking study population with state or local death certificate files directly or by obtaining state death certificate files. It may be necessary to link to state vital statistics data to ensure completeness of capturing all deaths

(m) FAMID FILE: The contractor shall provide a file that contains a single record for the birth mother associated with each VSD study member born as an MCO member during the years covered by the VSD project, and include the source of the linkage between birth mother and study member (e.g., birth data, health plan, algorithmic match)

(n) TEMP FILE: The contractor shall provide a file that contains a single record for the temperature taken at each outpatient visit during the period of data collection for the VSD Project.

(o) PROCDRE FILE:The contractor shall provide a file that contains a record for each ICD-9 or CPT procedure code a member receives during the period of data collection. All procedure codes need to be collected, except for the following CPT codes: 99201-99205, 99211-99215, 99241-99245, 99251-99255, 99271-99275, 99281-99285

(p) MEDICAID FILE: The contractor shall create a file containing the Medicaid status of each study member on an annual basis.

(q) The contractor shall describe additional computerized data components that would be available to be merged with other VSD files by unique record identification numbers, if needed in a specific study. Examples of such files may include, but not limited to laboratory and pharmacy data.

E. Data maintenance and Merging of Files

i. The contractor shall maintain the integrity of each data file on a continual basis by repeated error checking and editing procedures.

ii. The contractor will develop internal methods to conduct data quality checks.

iii. Allow government to conduct weekly and annual data quality reviews through the DDM

iv. The contractor will have ability to revise data files as identified through data quality checks by the government and do so when needed. At a minimum, revisions should be conducted within one month, however, there may be times when issues have been identified that are IT related and may take longer than one month. The contractor will be required to notify the Government and provide weekly updates on progress in resolving problems.

v. The contractor will develop a system for tracking changes and corrections to both cycle files and DDFs.

F. Contribution of data to assessments

i. Cycle files and DDFs prepared under this task order will be used for automated assessments. This includes contribution of automated data for surveillance assessments, such as RCA, and other automated epidemiologic analysis. The contractor shall prepare automated data for analysis. The contractor shall seek IRB approval and execute necessary DUAs as needed.

ii. The contractor shall be responsible to conduct chart reviews for up to 0.03% of their total enrolled population per year, as a necessary part of the VSD infrastructure and as deemed necessary by CDC.

9. DELIVERABLES

In order to verify deliverables relating to the creation of the DDM and the associated files, the CDC will run a SAS program to ensure that files are created and available for use.

Report summarizing technical information regarding data collection methods and data that will be collected at health plan and for use by the Government

Creation of a functional distributed data model for access of data by the Government. DDM shall meet all requirements as verified by government (see attachment for requirements)

Access to provisional data, containing the designated data files in SAS format with appropriate documentation

Creation of dynamic data files (DDFs) posted to appropriate directory on contractor’s DDM.

Creation of cycle 2011 files and posted to distributed data model

Provide monthly technical report 1 to CO (E) 1 to PO (E) Monthly

E= electronic version only

Contractors shall propose a delivery schedule and any additional deliverables that will enhance the contractor’s ability to manage and successfully complete the work and/or facilitate oversight by the COTR and VSD Project staff.

10. SPECIFIC TASK ORDER INSTRUCTIONS (to be included as part of technical proposal response in Volume 2)

Methodology and technical approach:

A. The Contractor should provide a narrative describing their technical understanding of the work and describing their internal capabilities:

i. Description of the contractor’s understanding of the administrative tasks

ii. Description of vaccine registry/electronic vaccination tracking system, explaining methods used to capture vaccination on the entire health plan population and how long health plan has been capturing vaccinations with this registry/vaccination tracking system

iii. Description of current data platforms and software which would be used to store and access VSD data created as outlined in this task order’s PWS

iv. Description of how entire population will be captured and incorporated into created VSD population

v. Description of the requirements for creating a distributed data model that will allow CDC researchers access to cycle files, dynamic data files, and other electronic data

B. The Contractor should describe the approach and methodologies in creating data files

i. Description of internal administrative data systems as well as electronic medical record systems and how these will be used to create the specified data files as listed in the data dictionary

ii. Description of how annual cycle files will be created. Annual cycle files will consist of all data files included in the data dictionary

iii. Description of how dynamic data files will be created. Include the frequency the contractor can update specific files and any delays or data lags that are expected for data to be settled

iv. Description of data quality and quality assurance processes that will be conducted for the annual cycle files and dynamic data files

Requirements of the VSD Distributed Data Model:

· SAS v8 Base and SAS v8 Stat or higher.

· Secure method for transfer of SAS Programs, SAS Logs, SAS Output, and SAS Datasets – SSH2 is currently being utilized

· “Scheduler” program

· Initiate the “processing job” program every 15 minutes

· Allow for at least 2 job processes occurring at the same time

· “Processing job”

· Transfer programs to a specified site

· Check for the VSDEOF statement

· Delete the programs from that site after download

· Submit the programs to SAS in order as specified by the *.run file

· Specify the location of the SAS Macros in the SAS Library “vsdcat”

· SAS Macros installed

· Getref macro - This macro issues a LIBNAME, FILENAME, or CATALOG statement to a pre-existing library, catalog, or file. Currently, the distributed data model requires the set-up of at least 15 pre-existing libraries including the following

· ML macro - This macro simply sends an email with a specified subject line. It uses a lookup table for emails addresses that are valid

· Makefile macro - is macro creates a file and a SAS reference to that file. It can create a SAS output or log file, a SAS XPORT file, or a SAS CPORT file. SAS output (ODS), log, and CPORT files have a SAS FILENAME assigned to the file while XPORT has a SAS LIBNAME assigned.

· Putfile macro - This macro sends the specified file to the CDC output. Currently, this file should be sent through the Secure Hub or other secure method of transfer to the CDC

· Upload macro – Creates upload macro to upload SAS datasets to vendors distributed data model.

· Specific Requirement Functions of Distributed Data Model

0. Programs downloaded from FTP

0. Emails received by CDC

0. Log files created and transferred

0. Cycle Library identified (C2011)

0. Output files created and transferred

0. Permanent CDC libraries available (VSDCDC1-VSDCDC6)

“HISTORY” and “EVENT” libraries available image1.wmf oleObject1.bin