Solication No. 2011-N-13406.pdf

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The Data Coordinating Center for HIV Supplemental Surveillance
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2011-N-13406
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Solicitation No. 2011-N-13406

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PAGES

15A. NAME

AND

ADDRESS

OF

OFFEROR

SEC. PAGE(S) SEC. PAGE(S)

(Date) (Hour)

CALENDAR DAYS

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amend-ments to the SOLICITATION for offerors and related documents numbered and dated:

(Type or Print)

SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

1 92

2. CONTRACT NO.

3. SOLICITATION NO.

2011-N-13406

4. TYPE OF SOLICITATION

SEALED BID (IFB)

X NEGOTIATED (RFP)

5. DATE ISSUED

06/02/2011

6. REQUISITION/PURCHASE

NO.

HCVJC5X2-2011-94312

7. ISSUED BY CODE 2543 8. ADDRESS OFFER TO (If other than Item 7) Centers for Disease Control and Prevention (PGO)

Acquisition and Assistance Branch 1 2920 Brandywine Road, MS E-15 Atlanta, GA 30341-5539

Centers for Disease Control and Prevention (PGO) Acquisition and Assistance Branch, 1 2920 Brandywine Road, MS E-15, Atlanta, GA 30341

Approved as to Form and Legality: _____________________________ NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and 3 handcarried, in the depository located in See Block 7 until 10:00 AM local time 07/6/2011 copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Sherrie N. Randall

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2866

C. E-MAIL ADDRESS

srandall@cdc.gov

11. TABLE OF CONTENTS

(x) DESCRIPTION (x) DESCRIPTION

PART I – THE SCHEDULE PART II – CONTRACT CLAUSES

X A SOLICITATION/CONTRACT FORM 1 X I CONTRACT CLAUSES 64

X B SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

X C DESCRIPTION/SPECS./WORK STATEMENT 4 X J LIST OF ATTACHMENTS 73

X D PACKAGING AND MARKING 31 PART IV – REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 32 REPRESENTATIONS, CERTIFICATIONS, AND

X F DELIVERIES OR PERFORMANCE 33 X K OTHER STATEMENTS OF OFFERORS 74

X G CONTRACT ADMINISTRATION DATA 49 X L INSTRS., CONDS., AND NOTICES TO OFFERORS 79

X H SPECIAL CONTRACT REQUIREMENTS 55 X M EVALUATION FACTORS FOR AWARD 88

OFFER (Must be fully completed by offeror) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

AMENDMENT NO. DATE AMENDMENT NO. DATE

CODE FACILITY 16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) 23. SUBMIT INVOICES TO ADDRESS SHOWN IN (4 copies unless otherwise specified)

ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 2543 25. PAYMENT WILL BE MADE BY CODE 434 Centers for Disease Control and Prevention (PGO) Acquisition and Assistance Branch, 1 2920 Brandywine Road, MS E-15, Atlanta, GA 30341

Centers for Disease Control (FMO) PO Box 15580 404-498-4050 Atlanta, GA 30330-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE Prescribed by GSA

FAR (48 CFR) 53.214©

K

Section B - Supplies Or Services And Prices/Costs

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 Base Year - Labor & ODCs

Data Management Suppor t for the Data Control Coordination Center to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the National HIV Behavioral Surveillance System and the Medical Monitoring Project Surveillance System

1 Job $_________ $_________

0002 Base Year Travel

1 Job $________ $_________

0101 Option Year I - Labor & ODCs

Data Management Suppor t for the Data Control Coordination Center to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the National HIV Behavioral Surveillance System and the Medical Monitoring Project Surveillance System

0102 Option Year I Travel

0201 Option Year II - Labor & ODCs

Data Management Suppor t for the Data Control Coordination Center to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the National HIV Behavioral Surveillance System and the Medical Monitoring Project Surveillance System

0202 Option Year II Travel

0301 Option Year III - Labor & ODCs

Data Management Suppor t for the Data Control Coordination Center to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the National HIV Behavioral Surveillance System and the Medical Monitoring Project Surveillance System

0302 Base Year Travel

0401 Option Year IV – Labor & ODCs

Data Management Suppor t for the Data Control Coordination Center to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the National HIV Behavioral Surveillance System and the Medical Monitoring Project Surveillance System

0402 Base Year Travel

Section C - Description/Specification/Work Statement

C.1. BACKGROUND STATEMENT AND NEED

The Centers for Disease Control and Prevention (CDC) developed an HIV Prevention Strategic Plan to guide efforts during the third decade of the HIV/AIDS epidemic. One of the four major goals of the HIV Prevention Strategic Plan is to “strengthen the capacity nationwide to monitor the epidemic…” The objectives related to this goal include developing an integrated surveillance system that will “monitor behaviors that place people at risk for HIV infection and provide locally relevant data for community planning.” An additional objective is to “develop a system to track disease, including prevalence of HIV, AIDS, and other Sexually Transmitted Diseases (STDs), incidence of AIDS and STDs, and HIV drug resistance and care utilization.” In response to the strategic plan, CDC’s Division of HIV/AIDS Prevention (DHAP) implemented two surveillance systems designed to supplement the HIV/AIDS case surveillance system: the National HIV Behavioral Surveillance system (NHBS) and the Medical Monitoring Project (MMP).

The National HIV Behavioral Surveillance The NHBS is CDCs most comprehensive system for conducting behavioral surveillance among persons at the highest risk for HIV infection in the US. In Fiscal Year 2010, CDC began the third round of NHBS funding through cooperative agreements with health departments. CDC developed the NHBS system to help state and local health departments establish and maintain a surveillance system to monitor selected behaviors and the use of prevention programs and services in groups at highest risk for HIV infection. NHBS, a community-based data collection system, currently functions in 21 cities and states throughout the US with plans to function in no more than 21 cities and states in the future. Findings from NHBS will enhance understanding and development of HIV prevention programs in these communities.

NHBS Project Area sites:

• Atlanta, GA

• Baltimore, MD

• Boston, MA

• Chicago, IL

• Dallas, TX

• Detroit, MI

• Houston, TX

• Denver, CO

• Los Angeles, CA

• Miami, FL

• Nassau, NY

• New Orleans. LA

• New York, NY

• Newark, NJ

• Philadelphia, PA

• San Diego, CA

• San Francisco, CA

• San Juan, PR

• St. Louis, MO

• Seattle, WA

• Washington, DC

The overall strategy for NHBS involves conducting three rotating cycles of data collection (approximately annually) in five different populations at high risk for HIV: young men who have sex with men (YMSM), transgendered persons (TG), men who have sex with men (MSM), injection drug users (IDU), and heterosexuals at increased risk of HIV infection (HET). Sampling methods to reach these groups include venue-based, time-space sampling and respondent driven sampling; thus, the number and type of data collected, processed, and maintained for NHBS differ each year although the sample size for each project area is 500-700 per year. There are generally five sources of data for NHBS:

• Screening and recruitment data

• Interview data

• HIV and Hepatitis test data

• Recruitment monitoring data

• Venue Based Day-Time Sampling (VDTS) data

The Medical Monitoring Project The MMP is the largest HIV supplemental surveillance system conducted by CDC. MMP began its second round of funding through a cooperative agreement with health departments beginning in fiscal year 2009. The purpose of MMP is to produce population-based estimates of characteristics of persons with HIV infection living in the US and the care they receive. Estimates developed using probability-based sampling are intended to be representative of the population diagnosed with and receiving care for HIV in the US. Findings from MMP will enhance public health policy, HIV prevention program planning, and evaluation of cost associated with the epidemic. The MMP multistage cluster sampling design is complex, and the services required for data management support are specialized. MMP currently functions in 16 states, the commonwealth of Puerto Rico and 6 separately funded cities in the US with plans to function in no more than 19 states, the commonwealth of Puerto Rico and 6 separately funded cities in the future.

MMP Project Area sites:

• California

• Chicago, IL

• Delaware

• Florida

• Georgia

• Houston, TX

• Illinois

• Indiana

• Los Angeles, CA

• Texas

• Virginia

• Washington

• New Jersey

• New York

• New York City, NY

• North Carolina

• Oregon

• Pennsylvania

• Philadelphia, PA

• Puerto Rico

• San Francisco, CA

• Michigan

• Mississippi

The MMP facilities are sampled every other year using probability-based methods. Participants are sampled annually using probability-based sampling methods. Each MMP project area collects interview and medical record abstraction data on approximately 400 – 800 sampled patients each cycle as well as facility attribute data on all potentially sampled facilities. Sampled patients either complete a standard or short (abridged version of the standard) interview. Patient medical records are abstracted to gather information on medical history, a summary of specific events during the surveillance period (e.g., vaccines, pregnancy), and medical information for any inpatient and outpatient visits during the surveillance period. There are potentially five sources of data for MMP for each cycle:

• Interview data

• Minimum data set

• Medical record abstraction data

• Facility attribute data

• Provider survey data

The Data Coordinating Center Given the size and complexity of HIV supplemental surveillance (NHBS and MMP), the $20 million annual investment in funding to health departments, and the critical need for these key data for HIV prevention, data management must meet or exceed standards for best practices. The NHBS and MMP require a comprehensive data management system that begins with setting up sampling frames, providing technical assistance, coordinating data collection to data processing, weighting, and data analysis, and all the way through to achieving a secure and timely means for data dissemination. Attempts at managing these data early on from 2004 to 2007 failed to produce data sets within an acceptable timeframe. In response, CDC funded a contract to evaluate current operations and recommend best practices for NHBS and MMP data management. Following those recommendations, a new data management contract was developed and awarded at the end of fiscal year 2008. Shortly after the award, The Data Coordinating Center (DCC) was established and became fully functional by June, 2008. The DCC marked a change from the “bit by bit” data management processes of the past and instead operates a highly coordinated life cycle system producing higher quality data sets in less time and at less cost than previous MMP and NHBS data management processes.

The DCC provides comprehensive data management lifecycle support for NHBS and MMP and utilizes the DCC data portal to support and maintain the data management lifecycle for NHBS and MMP. The DCC data portal is a secure Web-based system for receiving, maintaining, processing, and disseminating NHBS and MMP data. The DCC data portal facilitates and improves communications between CDC, project areas, and the Contractors supporting DCC functions. The portal provides a central location for project areas to acquire submission-related information, exchange data with the DCC and CDC, and monitor data collection and submission activities with a focus on quality assurance. The processing flow of the DCC data portal from system input to system output is represented in the figure below:

The MMP and NHBS collect data under the Guidelines for HIV/AIDS Surveillance – Security and Confidentiality (http://www.cdc.gov/hiv/topics/surveillance/resources/guidelines/guidance/). Additional protections include exemptions to the Freedom of Information Act of 1966 (specifically U.S.C. 552(b) [6]) and by the Privacy Act of 1974. The Assurance of Confidentiality, authorized by 308(d) of the Public Health Service Act, enables CDC to withhold disclosure of any HIV/AIDS surveillance related information. The DCC must also comply with federal Certification and Accreditation guidelines and any CDC specific information technology guidelines. Please refer to the Special Considerations Section – Security Compliance for a description of Certification and Accreditation guidelines.

http://www.cdc.gov/hiv/topics/surveillance/resources/guidelines/guidance/�

C. 2. PROJECT OBJECTIVES FOR THE DATA COORDINATING CENTER

The purpose of this acquisition is to provide support to continue the maintenance of the existing comprehensive standardized data management lifecycle system for the NHBS and MMP national surveillance systems. Refine existing processes and implement improvements to the existing DCC system that will achieve more efficient management of the data lifecycle and provide higher data quality. Specific project objectives include the following:

• Provide technical services and training for managing, generating and reconciling data errors, processing, and creating data sets for NHBS and MMP using the existing data management system including the DCC data portal.

• Provide technical services for developing an analysis plan for weighting the data, generation of response rate reports in accordance with American Association for Public Opinion Research standards non-response analysis and construction of weighted analysis data sets for each MMP cycle and for the MSM cycle of the

NHBS.

• Develop, test, and document programs to weight the data and to construct the weighted analysis data sets.

Produce detailed documentation, reports, and SAS code on the weighting process, to include intermediate analysis and decisions made.

• Maintain a searchable relational metadata database for MMP and include a NHBS component to allow cross-referencing and consistency of data collection instruments across data collection cycles (one for NHBS and one for MMP) to include variables, variable names, questions, labels, and response values.

• Provide a detailed data management manual to describe all processes, inputs, outputs and describe components of the system for end users.

C.3. SCOPE OF WORK: INCLUDES BOTH NHBS AND MMP

1. Support and maintain all features of the existing NHBS and MMP data management lifecycle system including all existing DCC data portal functions

2. Receive data from 21 NHBS and 23 MMP sites (CDC designated sites)

3. Process data for quality assurance to include documentation of processes

4. Create and transfer data sets to CDC and to project areas

5. Create a final weighted MMP data set for each cycle

6. Create a final NHBS data set for each cycle including a weighted final data set for the MSM cycle

7. Update the existing knowledge base of frequent technical contacts and solutions using search topics and terms provided by CDC

8. Document all data management, processing, and weighting services

9. Provide ad-hoc technical services

10. Maintain routine communication and reporting to CDC

11. Provide training sessions for NHBS and MMP project areas

12. Provide routine communication and reporting to CDC

13. Maintain a searchable database of information about all data collection instruments across all cycles for

MMP and include a NHBS component into the database.

14. Provide SAS programs for data management, data analysis, response rates, processing, and weighting to

CDC and project areas

15. Provide expert consultation on complex sampling and weighting calculations/techniques used. Document all techniques reviewed and used and provide SAS code

16. Create a national formatted de-identified data set using SAS formats

17. Provide statistical software training to enable project areas to analyze data

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, facilities, supplies, and equipment to maintain and administer a DCC as an integral part of NHBS and MMP using a phased-in approach to achieve each of the items listed in the Project Objectives and Scope of Work above.

BASE YEAR: 12 MONTHS (August 18, 2011 – August 17, 2012)

START-UP: 3 MONTHS (August 18, 2011 – November 17, 2011)

The Contractor shall set up and prepare to support the existing DCC system including the data portal as a secure and confidential system for sampling, receiving, storing, weighting, and transferring data. Contractor shall begin Certification and Accreditation for federal information technology systems process as described in the Special Considerations Section – Security Compliance.

TRANSITION: 9 MONTHS (November 18, 2011 – August 17, 2012) The Contractor shall support existing NHBS and MMP data management system including the DCC data portal and implement improvements to the system The Contractor shall also support the existing data management system and implement the proposed Operational Plan.

OPTION YEARS 1 - 4: 48 MONTHS (August 18, 2012 – August 17, 2016) The Contractor shall support NHBS and MMP data management system as proposed in the Operational Plan.

C.4. TECHNICAL REQUIREMENTS

The Contractor shall perform the following tasks:

BASE YEAR: (12 months)

START-UP: (3 months) Task 1: Kick-Off Meeting: Travel to Atlanta, Georgia for a two day meeting with the

Contracting Officer Technical Representative ( COTR), one month after award to conduct introductions, obtain contact information, and address initial start up questions. The Contractor shall provide the COTR with meeting minutes within seven business days of the kick-off meeting.

Task 2: Transfer of existing DCC system: The Contractor shall transfer the existing DCC system from the current location in Maryland to the new contractor site as proposed in the Operational Plan. The contractor shall provide a system location description to the COTR. See the table below describing existing DCC system components:

Name Manufacturer/

Model Processor Memory Operating

System Software

CDC-DCC-ROCWEB

190.168.100.5 Dell 2950

Intel Xeon E5420 2.50

GHz 8G

MS Windows 2008 Server Standard SP1

Microsoft Internet Information Services 7, McAfee Virus Scan 8.5, Symantec Backup Exec Remote Agent Utility, Microsoft .NET Framework Version 2.0 Service Pack 1, Microsoft .NET Framework Version 3.5 Service Pack 1

CDC-DCC-ROCSQL

190.168.100.10 Dell 2950

Intel Xeon E5420 3.00

GHz 16G

MS Windows 2008 Server

Standard SP1

Microsoft SQL Server 2008 (build 10.0.1600), Check Point Smart Console R65, Symantec Backup Exec for Window Server 12.5

CDC-DCC-ROCSAS

190.168.100.15 Dell 2950

Intel Xeon E5420 3.33

GHz 16G

MS Windows 2008 Server

Standard SP1

SAS Version 9.1.3 (Base , SAS/STAT, SAS/GRAPH, SAS/ETS, SAS/FSP, SAS/OR, SAS/QC, SAS/SHARE, SAS/CONNECT, SAS Integration Technologies, SAS/ACCESS Interface to ORACLE, SAS/ACCESS Interface to PC Files, SAS/ACCESS Interface to ODBC , SAS/ACCESS Interface to OLE DB, SAS Management Console, SAS Information Map Studio), QDS Warehouse Manager 2.4, QDS Warehouse Manager, CAPI, HAPI 2.5

CDC-DCC-ATLWEB

190.168.200.5 Dell 2950

Intel Xeon E5420 2.50

GHz 8G

MS Windows 2008 Server

Standard SP1

Microsoft Internet Information Services 7, McAfee Virus Scan 8.5, Symantec Backup Exec Remote Agent Utility, Microsoft .NET Framework Version 2.0 Service Pack 1, Microsoft .NET Framework Version 3.5 Service Pack 1

CDC-DCC-ATLSQL

190.168.200.10 Dell 2950

Intel Xeon E5420 3.00

GHz 16G

MS Windows 2008 Server

Standard SP1

Microsoft SQL Server 2008 (build 10.0.1600), Check Point Smart Console R65, Symantec Backup Exec for Window Server 12.5, Task 3: Data Security and Confidentiality: The Contractor shall begin the Certification and Accreditation process immediately after contract award (see Special Considerations Section – Security Compliance for a detailed description of requirement). Contractor staff shall submit a signed data security and confidentiality statement prior to receipt of any data. Contractor staff cannot receive and process data until Contractor systems are compliant with data security regulations and the system has received an Authorization to Operate (ATO) indicating the Certification and Accreditation process is complete. The Contractor shall follow all security and confidentiality procedures required for the collection of HIV/AIDS surveillance data. Data security regulations and procedures for compliance are detailed in the Special Considerations Section – Security Compliance.

TRANSITION: (9 months) During the Transition period, the Contractor shall:

• support existing data management system including the DCC data portal

• provide data management and analysis training

• provide documentation of data management activities

• provide final NHBS and MMP data sets

• implement improvements to the system as proposed in the Operation Plan

The approximate number of electronic records the DCC will be required to transmit and store in accordance with federal information system security procedures is as follows:

• MMP

o Patient Interview

1 standard patient interview = 10,000 records per cycle 1 short (abbreviated standard version) patient interview = 1,000 records per cycle

Number of variables in 1 standard patient interview record = 967 Number of variables in 1 short patient interview = 209 o Medical Record Abstraction Data Medical History Form (MHF)

• 10,000 records per cycle

• Number of records per patient = 1 per cycle

• Number of variables in 1 MHF record = 516

Surveillance Period Visit Forms (SPVF)

• 60,000 records per cycle

• Average number of records per patient = 10 per cycle

• Number of variables in 1 SPVF = 1,232

Surveillance Period Inpatient Form (SPIF)

• 2,000 records per cycle

• Average number of records per patient = 1.5 per cycle

• Number of variables in 1 SPIF = 1,191

Surveillance Period Summary Form (SPSF)

• Average number of records per cycle = 10,000

• Number of variables in 1 SPSF = 389 o Facility Attribute data Number of facility attribute records = 800 Number of variables in 1 record = 110 o Minimum Data Set Number of minimum data set records = 10,000 Number of variables in 1 record = 25 o Provider Survey Number of provider survey records =1,000 Number of variables in 1 record =125

• NHBS

o Participant Interview

1 participant interview = 20,000 records per cycle Number of variables in 1 participant interview record = 889 o Recruitment data for Respondent Driven Sampling cycles Number of records (eligible and ineligible participants) = 20,000 per cycle Number of variables in 1 record = 30 o Venue data for Venue Based Sampling cycles Number of venues = 2,000 Number of variables in 1 record = 70 o Testing data Number of HIV tests = 20,000 per cycle

• Number of variables in 1 record = 12 Number of Hepatitis tests = 10,000

• Number of variables in 1 record = 15

Task 1: Support Existing Data Management System including the DCC data portal: The Contractor shall support the existing data management system including the DCC data portal. The DCC data portal is a secure Web-based system for receiving and disseminating NHBS and MMP data. The purpose of the DCC data portal is to facilitate and improve communications between CDC, project areas, and the DCC. The portal provides a central location for project areas to acquire submission-related information, exchange data with the DCC and CDC, and monitor data collection and submission activities. While supporting the existing data management system including the DCC data portal during the Transition period in the base year, the Contractor shall implement refined processes to improve the existing system as outlined in the proposed Operational

Plan. Please refer to Attachment A to review existing MMP and NHBS data management manuals which include a description of the data portal. Please refer to Attachment B to review screen shots of the existing DCC data portal data management system.

Subtask 1a Support existing data management system for receiving and disseminating data: The Contractor shall begin receiving MMP data, for data management no later than Month 3 of the contract as described in the Operational Plan which must include the following for 23 project areas:

• Interview data

• Medical record abstraction data

• Data error logs

• Facility tracking logs

• Patient tracking logs

• Schedule and calendar data

The Contractor shall begin receiving NHBS data, for data management no later than Month 3 of the contract as described in the Operational Plan which must include the following for 21 project areas:

• Interview data

• Coupon manager data (HET and IDU cycles) or venue based data (MSM cycle)

• HIV and Hepatitis test data

• Lost interview log

• Error correction log

The Contractor shall report any problems receiving and disseminating data within 1 week of identifying the problem to the COTR through the data portal. The Contractor shall begin disseminating processed MMP data sets to project areas no later than 1 month after receiving project area data. The Contractor shall begin disseminating processed NHBS data no later than 1 week after receiving project area data. The Contractor shall use the existing DCC data portal to receive, manage, and disseminate all NHBS and MMP data.

Please refer to Attachment A, MMP and NHBS data management manual for a description of the existing system for receiving data.

Subtask 1b Support existing data monitoring, tracking, and reporting system: The Contractor shall support the existing system to monitor, track, and report receipt and delivery of data to and from project areas, CDC, and the DCC. The Contractor shall support the existing system to track, monitor, and report data collection and sampling activities. The Contractor shall use the existing DCC data portal to monitor, track, and report on the progress of all aspects of NHBS and MMP data including data for weighting and sampling. In addition, the Contractor shall consider new IT solutions as proposed in the Operational Plan, including incorporating tracking system features developed by project areas for local use, to improve the DCC data portal. Some examples of the existing data reporting features of the DCC data portal include summary tables, maps of the distribution of NHBS and MMP samples, and a calendar for tracking MMP interview and abstraction assignments. Please refer to Appendix A to review data monitoring and tracking reports generated by the DCC and posted on the DCC data portal.

Subtask 1c Support existing data collection and sampling systems: The Contractor shall support existing data collection systems used to gather NHBS and MMP data as described in the Operational Plan. The Contractor shall report any problems supporting the data collection and sampling systems within 1 week of identifying the problem to the

COTR through the data portal. The Contractor shall also support systems to collect and manage NHBS and MMP data for sampling and weighting. Support of existing data collection and sampling systems for MMP must include the following:

• One MMP facility sample for each of the 23 project areas

• One MMP patient sample for each of the 23 MMP project areas

• Documentation of the methods used to create the samples, which must be reproducible using the documentation.

Support of existing data collection and sampling systems for NHBS must include the following:

• Coupon manager data for 21 NHBS project areas for IDU and HET cycles

• Venue based data for 21 NHBS project areas for the MSM cycle

Please refer to Attachment F, MMP Operations Manual for a description of the existing data collection and sampling system for MMP. Please refer to Attachment G , NHBS HET2 Operations Manual for a description of the Respondent Driven Sampling Methods used by NHBS for the IDU and HET cycles. Please refer to Attachment H, NHBS MSM Operations Manual for a description of the venue based sampling methods used by NHBS in the MSM cycle.

Data sampling methods include the following:

• Respondent Driven Sampling (NHBS)

• Venue Based Sampling (NHBS)

• Probability Proportional to Size (PPS) based sampling (MMP)

• Real-time sampling (MMP)

Data collection instruments include the following:

• Questionnaire Development System (QDS) or IBM® SPSS® Data Collection

• Medical Record Abstraction application (MRA)

• Coupon Manager Application

• Respondent Driven Sampling Analysis Tool

• Venue Based Day Time Sampling Application

• Microsoft Excel

• Minimum Data Sets (MDS)

Subtask 1d Support each existing NHBS database and MMP database: The Contractor shall maintain the existing NHBS and MMP databases. The databases must store the library of information collected from the project sites in a well organized, accessible format. They are not static; changes must constantly be made as material is added, removed, and moved around. The parameters within the database may change as data managers decide to use different indexing systems that make data more accessible.

Database maintenance is used to keep the database clean and well organized so that it will not lose functionality. Maintenance is performed as new data are coming in and shall not be done only at the end of each data collection cycle.

Database maintenance also includes backing up the database so that if anything happens, there will be another copy available. Back-up systems should be automatic, sending a backup to another location at least every 24 hours. Other expected maintenance activities include checking for signs of corruption in the database, looking for problem areas, rebuilding indexes, removing duplicate records, and checking for any abnormalities in the database which might signal a problem. In addition, the Contractor shall consider implementing new IT and database management solutions as proposed in the Operational Plan for NHBS and MMP that will achieve higher data quality.

The Contractor shall report any unanticipated database maintenance problems, including security or indexing, missing data, data inconsistencies, and problems with the data management system including the DCC data portal. Problem reports are due to the COTR through the data portal no later than 1 week after identification. Reports shall include recommendations for correcting, minimizing, or avoiding data-related problems.

The Contractor shall work to resolve data-related issues and provide feedback to ensure understanding and resolution of the problem (see Technical Assistance section in Task 2 below).

Subtask 1e Support existing data processing systems: The Contractor shall support existing systems used to process NHBS and MMP data. The Contractor shall support existing DCC data portal systems for processing data. The Contractor shall use existing NHBS and MMP quality assurance processes to include confirmation and documentation of corrections; repeating errors; documentation of circumstances that cannot be corrected;

and documentation of changes made to the data and/or data management system. Please refer to Appendix A to review existing data processing systems.

The Contractor shall report any unanticipated data processing problems, including missing data, data inconsistencies, and problems with the data management system including the DCC data portal. Problem reports are due no later than 1 week after identification. Reports shall include recommendations for correcting, minimizing, or avoiding data-related problems. The Contractor shall work to resolve data-related issues and provide feedback to ensure understanding and resolution of the problem (see Technical Assistance section in Task 2 below).

Task 2: Technical Assistance: The Contractor shall provide technical assistance to CDC, and to the MMP and NHBS project areas, using existing systems including the DCC data portal.

The approximate number of technical assistance calls/emails the DCC will be expected to receive and address per cycle is as follows:

• MMP = 1,000 per cycle

• NHBS = 500 per cycle

Technical assistance, communication and coordination with the CDC and project area sites shall primarily occur via telephone, e-mail, fax, or in writing. The Contractor shall also provide direct assistance at CDC facilities or at project area facilities.

The Contractor shall visit up to 12 of the following MMP and NHBS project area sites during the base year to provide technical assistance, California, Illinois, Delaware, Florida, Georgia, Texas, Indiana, Virginia, Washington DC, Washington State, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Puerto Rico, Michigan, Mississippi, Missouri, Louisiana, Maryland, Massachusetts, or Colorado.

The contractor shall coordinate meeting space logistics with the project area sites, attend planning meetings and help document decisions and incorporate those decisions into subsequent protocols.

Site visits shall occur over a 2-day time period . The contractor shall submit a site visit report to the COTR no later than 1 week after the visit. The report shall include names of staff visited, purpose of the visit, and findings and/or recommendations not to exceed two pages.

Subtask 2a Help-desk support: As questions for support come in, the Contractor shall respond no later than one business day after the call or email. The Contractor shall summarize and record issues in a “Help Desk Report”. The report should include reason for the call or issue, resolution, and response time provided via email to the CDC COTR on a quarterly basis.

Topics for Help-desk support include the following:

• Software for managing and collecting data locally (listed above in Subtask 1b)

• Security software such as PGP

• Questions about sampling

• Data entry processes

• Data editing, coding, and verification

• Programming for personal computers, local area networks, or the internet

• Database development

• Data transfer

• Specialized programming using common statistical analysis software (e.g., SAS, SPSS, Stata, Sudaan)

• SAS survey methodology techniques to perform weighted data analysis

• Conducting data analysis for project area monitoring purposes

• Questions about tracking and monitoring reports

The Contractor shall be available to NHBS and MMP project area staff via phone and a dedicated email account, set up for providing technical assistance (Help-desk Support).

The Help-desk shall be set up no later than 3 months after the contract is awarded. The Contractor shall be available to provide technical assistance for a minimum of 45 hours per week. The Help-desk shall be available during times of day and days of the week that are consistent with the core hours of the project area sites (e.g., 9:00 AM to 6:00 PM.

Monday through Friday Eastern Standard Time (EST)). Recorded messages shall be used outside of routine business hours since NHBS and MMP data collection events occur evenings and weekends. The systems used to record technical assistance contacts must be user friendly and address the caller/emailer issue no later than one business day after the call or email was made. The Contractor shall propose methods that will reduce the likelihood that data management issues will come up during data collection events that occur outside normal business hours. Please refer to Appendix A to review help-desk features of the existing system.

Subtask 2b Support Knowledge Base: The Contractor shall document all technical assistance contacts from CDC, NHBS and MMP project areas. The Contractor shall notify CDC of recurring (occurring more than once) technical assistance contacts and solutions that may be useful if shared across project areas. Recurring technical assistance contacts and solutions approved by CDC shall be documented in a searchable knowledge base maintained on the DCC data portal. The knowledge base shall be searchable using search topics and terms provided by the CDC. The knowledge base shall describe what problems were raised and how they were resolved. The purpose of the knowledge base is to gather and document additional information about recurring issues and share solutions across project area sites. To that end, the knowledge base shall be posted on the DCC data portal accessible to CDC and project area staff. Please refer to Appendix A to review knowledge base features of the existing system.

Subtask 2c Technical Support Communication: The Contractor shall organize and participate in monthly conference calls to discuss issues related to data management and problem solving based on need as determined by CDC. The calls shall begin no later than 6 months after contract award. The Contractor shall develop agendas for the calls and email the agendas to the project area sites once they are reviewed and accepted by the COTR, 1 week prior to the meetings.

The Contractor shall propose other means to update the project area sites as data management systems evolve and change. Such means may include meeting summary notes, newsletters, instruction sheets, Question and Answer fact sheets, or mass emails.

Please refer to Appendix A to review communication features of the existing system.

Subtask 2d Procure NHBS graph editor: The Contractor shall procure a graph editor for use as part of the DCC. The NHBS project areas will access this DCC component to quickly generate drawings and apply automatic layouts to social networks, using NHBS- HET or NHBS-IDU data. The application must be run on NHBS (HET or IDU) data on a weekly basis and enable users to view the networks of the current samples (of IDU and

HET) on the DCC data portal. The application must be able to handle multiple relations at the same time, and use node attributes to set and/or change the colors, shapes, and sizes of nodes. The program must allow the user to easily turn on and off groups of nodes defined by any variable in the data set (e.g., gender, race, HIV status, etc.). Pictures of the networks should be able to be saved in metafile, jpg, gif and bitmap formats to see the network characteristics for all data on all variables. Network diagrams must be able to be saved as bitmaps (.bmp), jpegs (.jpg), windows metafiles (.wmf) and enhanced metafiles (.emf). In addition, the program should have the capability to export to Pajek and Mage.

Subtask 2e Technical Support and Data Management Manuals: The Contractor shall develop documentation of procedures of the data management system as proposed in the Operations Manual. The technical support and data management manuals (one for NHBS and one for MMP) shall be posted on the DCC data portal no later than 1 week prior to the start of data collection. NHBS and MMP data collection begin annually in August 2011.

Task 3: Data Management and Analysis Training Sessions: The Contractor shall provide data management and analysis training sessions one time per year for NHBS project area sites and one time per year for MMP project area sites as detailed in Sub-task 3a and 3b below.

The Training Sessions shall be developed and scheduled no later than 8 months after contract award. All in-person training shall be held in Atlanta, GA.

Topics for the sessions shall be tailored to each surveillance program (NHBS and MMP) to include the following:

• Software for collecting and managing data locally (listed above in Subtask 1b)

• Graph editor software

• Data security requirements and software

• Data entry processes

• Data editing, coding and verification

• Programming for personal computers, local area networks, or the Internet

• Database development

• Data transfer

• Specialized programming using common statistical analysis software (e.g., SAS, SPSS, Stata, Sudaan)

• Conducting data analysis for project monitoring purposes

• How to analyze weighted data using common statistical analysis software (SAS survey methodology techniques)

Subtask 3a NHBS Training Session: The Contractor shall develop and implement a data management and analysis training session for NHBS onetime per year. Data management training shall be in-person in the base year and option year 2 in Atlanta, GA.

During option years 1, 3 and 4, data management and analysis training will be conducted over the internet. Training curriculum and a letter of invitation shall be developed by the Contractor. The Contractor shall provide supporting training tools (handouts), equipment to include one laptop per participant for hands-on training for the duration of the training (if in-person training), and/or power point presentations for a 1 or 2 day training session that will include approximately 50 participants. The training sessions shall include representatives from all NHBS project areas and CDC staff. Two weeks prior to the training, the Contractor shall present the draft agenda and training materials to the COTR for review and approval.

Subtask 3b MMP Training Session: The Contractor shall develop and implement a data management and analysis training session for MMP one time per year. The training must take place in-person, in Atlanta, GA during the base year and option years 2 and 4.

During option years 1 and 3, data management and analysis training will be conducted over the internet. Training curriculum and a letter of invitation shall be developed by the Contractor. The Contractor shall provide supporting training tools (handouts), equipment to include one laptop per participant for hands-on training for the duration of the training (if in-person training), and/or power point presentations for a 2 or 3 day training session that will include approximately 60 participants. The training sessions shall include representatives from all MMP project areas and CDC staff. Two weeks prior to the training, the Contractor shall present the draft agenda and training materials to the COTR for review and approval.

Task 4: Create Final NHBS and MMP Data Sets: The Contractor shall create and transfer final data sets to CDC and project area sites. Final NHBS- Men who have Sex with Men (MSM) data sets shall be weighted based on criteria and methodology approved by CDC.

All final MMP data sets shall be weighted based on criteria and methodology approved by CDC. A SAS program to create weighted data sets shall be provided with the final data. The data set shall be encrypted and transferred to CDC and the respective project areas using the DCC data portal and in accordance with Federal regulations as provided in the Special Considerations Section.

Subtask 4a Create and Transfer Final NHBS Data Sets: The Contractor shall provide final data sets to CDC no later than 2 months after data collection ends each cycle. A weighted final data set shall be provided for the MSM data collection cycle no later than 2 months after data collection ends. The Contractor shall provide each participating NHBS project area site a data set that includes data from that site for the cycle. Final data sets for NHBS shall include merged records for each case, including recruitment data, survey data, and HIV and Hepatitis testing data, as appropriate. A codebook, SAS formats, labels, and calculated variables for analysis shall be provided with the final data set to CDC for approval before being sent to project area sites. The final data sets shall be complete, error free and provided in SAS format. The data set shall be encrypted and transferred to CDC and the respective project areas using the DCC data portal and in accordance with Federal regulations as provided in the Special Considerations Section.

Subtask 4b Create and Transfer Final MMP Weighted Data Sets: The Contractor shall provide final MMP data sets no later than 2 months after the end of each data collection cycle. Final data sets shall be transferred to each participating MMP project area and a composite data set shall be transferred to CDC. Final weighted data sets shall include (1) interview data, (2) chart abstraction data, (3) sampling and progress data, (4) tracking and minimal data on all sampled patients, (5) SAS formats and labels, (6) a codebook for each data set, (7) calculated variables for analysis, and (8) facility attribute data for each data set. The data sets shall be provided in SAS format, and shall include error free data from all MMP project areas. The data set shall be encrypted and transferred to CDC and the respective project areas using the DCC data portal and in accordance with Federal regulations as provided in the Special Considerations Section.

Subtask 4c Create de-identified final NHBS and MMP data set: The Contractor shall create a de-identified final data set (one for NHBS and one for MMP) for CDC to make available to non-CDC researchers. De-identification of the final data sets shall occur in accordance with the following CDC guidelines:

http://www.cste.org/pdffiles/2005/drgwgreport.pdf specifically, the Contractor shall follow the data release procedures discussed on pages 37 through 49 of the guidelines.

The Contractor shall provide CDC with SAS code for creation of the de-identified final data sets; a codebook; and instructions for how the final de-identified data sets were created. The Contractor shall provide the documentation explaining the use of the data sets that is consistent with the guidelines above. The de-identified data sets shall be provided to CDC no later than 6 months after the end of each data collection cycle. The http://www.cste.org/pdffiles/2005/drgwgreport.pdf� data sets shall include error free data using SAS formats from all NHBS and MMP project areas sites. The data sets shall be encrypted and transferred to CDC and the respective project areas using the DCC data portal and in accordance with Federal regulations as provided in the Special Considerations Section.

Subtask 4d Data Set Documentation: The Contractor shall develop electronic documentation of all data sets, to be delivered in conjunction with the final data sets at the end of each data collection cycle. The documentation shall include a data dictionary/codebook and a copy of each data collection instrument with variable names specified on each instrument (one for NHBS and one for MMP). In addition, a guidance document reviewing considerations for analysis of data shall be developed for NHBS and for MMP final data sets. The guidance document shall be no more than 50 pages and shall include options for weighting and a discussion of limitations. The guidance document shall be delivered to the COTR no later than 2 months after the end of each data collection cycle. Recruitment statistics for each project area and overall shall be part of the data documentation. The data dictionary/codebook must also include the following elements:

Each variable is represented in the codebook/data dictionary documentation with a page or entry containing all of these elements, which are described in turn below:

• Variable name

• Variable type

• Question text

• Universe statement

• Response categories and unweighted frequencies

• Notes, where applicable

Subtask 4e Interim Data Sets: The Contractor shall provide cumulative interim data sets for NHBS and MMP data during each data collection cycle. The interim data sets shall include all types of data collected up to a specific date that can be used by CDC researchers to check data for completeness. The interim data sets shall enable CDC to check the quality of the data against reports that appear on the DCC data portal for accuracy. The Contractor shall begin sending interim data sets no later than 5 months after data collection begins. The Contractor shall send interim data sets to CDC every 2 months after the initial interim data set until the end of the cycle.

Task 5: Support the Searchable Metadata Database for MMP and include an NHBS component: Support a searchable relational metadata database (one for NHBS and one for MMP) to allow cross-referencing and consistency of data collection instruments across data collection cycles to include variables, variable names, questions, labels, formats, and response values. The purpose of the metadata database is to gather and document information about each data collection instrument to assist project area sites with analyzing data across data cycles. To that end, the metadata database shall be posted on the DCC data portal accessible to CDC and project area staff.

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