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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 22, 2013 FBO #4228
SPECIAL NOTICE

B -- Examining the Role of Transitional Care in Facilitating Quality Clinical Health Care and Preventive Services for Adults Survivors of Childhood Cancer - Sole Source Justification

Notice Date

6/20/2013
 

Notice Type

Special Notice
 

NAICS

622310 — Specialty (except Psychiatric and Substance Abuse) Hospitals
 

Contracting Office

Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
 

ZIP Code

30341-4146
 

Solicitation Number

2013-N-57282
 

Archive Date

7/20/2013
 

Point of Contact

Porcelain Smith-Perkins, Phone: 7704883281, Julio E Lopez, Phone: 404-639-6401
 

E-Mail Address

xae5@cdc.gov, ftg4@cdc.gov
(xae5@cdc.gov, ftg4@cdc.gov)
 

Small Business Set-Aside

N/A
 

Description

The attached document is the Justification for Sole Soure for this procurement NOTICE OF INTENT TO SOLE SOURCE. The Centers for Disease Control and Prevention (CDC) announces its intention to negotiate a sole source award with the Childhood Cancer Survivorship Study Coordinating Center at St. Jude's Children's Research Center, Memphis, TN for the reasons included in the attached Sole Source Justification. The objectives of this contract are to: 1. Examine the type, frequency and integration of evidence-based transitional care services offered to adult survivors with a history of childhood cancer. 2. Examine the association between health care engagement and physical and psychosocial health outcomes of adult childhood cancer survivors based on their receipt of transitional care services provided to them in their treating institution. 3. Identify which models/ guidelines of TC equate to the highest rate of successful transfer to adult-focused LFTU care. 4. Examine how survivors' unique personal characteristics ( medical, psychosocial and socioeconomic), attitudes about TC ( level of thought, interest, anticipated difficulty, and perceived importance of TC), and knowledge of individual TC serve as facilitators or barriers to successful transition to adult health care providers and receipt of recommended follow-up care. Specifically, the contractor shall perform the following tasks on this project: Task 1 - The contractor shall arrange and facilitate weekly conference calls with the CDC Contracting Officer's Representative (COR) until the work described in this contract has been completed. Within 1 week of the effective date of the task order, the contractor shall arrange an initial conference call with the CDC COR to ensure that the work structure, points of contact, roles and responsibilities, and the protocol for communication (detailed in Tasks 2 through 13) are understood. The contractor shall prepare an agenda and all related documentation to be discussed during weekly conference calls before each conference call and send it to the CDC COR no later than 2 days before each call. All meeting minutes from each conference call shall be submitted to the CDC COR within 1 week of the conference call. Task 2 - The contractor shall submit to the CDC COR monthly progress reports throughout the duration of the project. Progress reports must be e-mailed to the CDC COR on the 10th of each month. Task 3 - Protocol planning meetings. Within three weeks of the effective date of the task order, the contractor will convene two study planning conference calls with the CDC COR to discuss details of the study protocol including the following: • Additional inclusion and exclusion criteria for study participants, • Additional considerations for participant recruitment and consenting, • Survey questions proposed to the contractor for inclusion on the Childhood Cancer Survivorship Study (CCSS) Transitional Care Ancillary Survey, • Plans for cognitive testing of survey questions • Plan for data collection and database construction • Plan for data analysis, translation and dissemination Task 4 -Develop survey instrument, an outline of the database structure, and manuals for training study personnel. The contractor shall develop a survey instrument to capture data items to answer study questions. The following survey questions should address: • Medical, psychosocial and socioeconomic characteristics which impact receipt of preventive and follow-up health care services; • Level of thought about and interest in TC, anticipated difficulty accessing TC, and perceived importance of TC; • Knowledge of individual transition plans; • Perceived relationship with provider(s); • Retrospective and prospective report of their patient-provider discussions about transition care; • Receipt of care plans and information included in care planning; • The number and type of providers seen since initial diagnosis; • Type of facility where patients currently receive follow-up care; • Reported secondary malignancies and/or chronic conditions; • Routine receipt of general or survivorship focused follow-up care • Report receipt of cancer screening (routine or otherwise) The contractor shall deliver a draft survey instrument, associated training materials for study personnel, and a draft outline of the electronic survey database structure within 6 weeks of award of contract. CDC will review and approve the instrument, instructions and manuals for training personnel. All final decisions regarding study questions to be included on the ancillary survey shall be made by the contractor. Task 5 - Develop study protocol. The contractor shall develop and refine a study protocol that will address the topics listed above within 8 weeks following initial planning meeting (see Task 3). The study protocol will identify the role of each investigator; the background, rational and scientific significance of the study; the study population (including participants selection criteria, estimated number of participants available by age/ race/ ethnicity/ cancer type); study methods and procedures (including process of patient selection, process of data collection, process for linkage with other data sources); study time line; quality control procedures; data analysis plan (including data entry, data editing, data management and statistical methodology); procedures for records management (handling and storage of chart review forms and computer files); procedures for protection of privacy and confidentiality of patients; and the risks and benefits of study participation including how risks will be minimized and benefits maximized. Any algorithms for exclusion of patients should be described in detail. Statistical power calculations for the number of cases needed to address the major study questions should also be included. CDC COR will review and approve the protocol. Task 6- Submit protocol for approval from human subjects review. The contractor shall submit the CDC approved protocol and survey instrument to the CDC IRB for approval within 10 weeks of the effective date of the task order. These documents will need to be approved by the CDC COR prior to submission to the CDC IRB. The contractor shall also submit these documents to their local IRB for approval. The contractor will be responsible for responding to CDC and local IRB reports. If OMB clearance is required, the contractor shall prepare OMB submissions. Task 7-Recruitment and consenting of study participants. Within 2 weeks of IRB approval the contractor shall begin identifying CCSS study cohort participants that meet inclusion criteria for the proposed study, and use the standard CCSS recruitment format to randomly recruit and obtain consent from participants. Recruitment and consenting for cognitive testing shall be completed within 6 weeks of IRB approval. All study recruitment for participants who are not part of cognitive testing and are being recruited for the general study, shall be completed within 16 weeks of initial IRB approval. Task 8- Cognitive testing, revise and finalize survey instrument. The contractor shall cognitively test the draft survey instrument on a random selection of cases identified in Task 7 within 12 weeks of IRB approval. The contractor shall summarize information on individual survey questions and report results to the CDC COR and the other site investigators within 14 weeks of IRB approval. With input from CDC and site investigators, the contractor shall make revisions to the instrument. The revisions will be submitted byt the contractor for CDC and local IRB approvals. Submission of an IRB amendment detailing any revisions to the survey instrument shall be submitted for IRB approval no later than 16 weeks after the original IRB approval. Task 9- Constructing electronic database and codebook. Within 2 weeks of the survey instrument tool being finalized and approved by the IRB, the contractor shall develop a final electronic database (for SPSS and SAS import) with a code book. Task 10- Within 3 week of the survey instrument being finalized, the contractor shall begin to collect survey data from all participants identified as part of Task #7. Task 11- Final dataset and data dictionary. Upon completion of data collection, the contractor shall enter all data into the electronic database (SPSS and SAS data file) for analysis. The contractor shall compile a data dictionary describing the database structure in SPSS and SAS. The contractor shall ensure that all investigators who handle data and records related to the study keep the data and records in a locked storage facility. After data collection has been completed, the contractor shall ensure all paper and electronic sources of personal health information (e.g., names, contact information, dates of birth and diagnosis) will be destroyed/ removed. Subjects will be linked through a project-specific ID that can only be linked to study participants by the contractor. These tasks shall be completed within 4 weeks of completion of data collection. The contractor shall deliver a de-identified dataset to the CDC COR. Task 12- Data analysis and manuscript preparation. The contractor shall meet (via conference call) with the CDC COR and other investigators to discuss data analysis and manuscript preparation. This meeting will be held within 5 weeks of completing data collection. Within 9 weeks of completion of data collection, the contractor shall analyze data according to a mutually agreed upon set of analytic procedures. Data analysis will be reviewed and approved by the CDC COR. The CDC COR and co-investigators will prepare designated manuscripts describing the results of the analyses. The contractor and all investigators from the CDC will be co-authors on all papers utilizing the study dataset. The CDC COR will assume first authorship for two of the manuscripts, which will be completed within 13 weeks of completing data collection. CDC will need to clear these manuscripts for publication before the end of the study. Task 13- Final Report. Within 3 weeks before the completion of the contract, the contractor shall furnish a draft final report including a project background, a detailed description of the methods used, and final results from manuscripts submitted for publication. The draft report shall be reviewed and approved by CDC. The final report shall be delivered no later than 1 week before the end of the contract period. Within 1 week before the contract ends, the contractor shall also arrange a conference call with CDC project staff for debriefing and to present study history and the results. CDC intends to negotiate this requirement with St. Jude Children's Research Hospital under the authority of FAR 6.302-1 and HHSAR 306.302-1, Only One Responsible Source, and 41 U.S.C 253(c)(1). This notice of intent is not a request for competitive proposals. A determination to compete this procurement based on a response to this notice is soley within the discretion of the Government. Interested parties who believe they possess the capabilities to satisfy this requirement should submit a capability statement demonstrating their abilities to meet this requirement. All responses should be received by July 5, 2013, at 3 PM, Eastern Standard Time (EST). All responses must be in writing and can be sent via email at xae5@cdc.gov. No phone calls will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2013-N-57282/listing.html)
 

Place of Performance

Address: Childhood Cancer Survivor Study St. Jude Children's Research Hospital, Department of Epidemiology, Mail Stop 735, 262 Danny Thomas Place, Memphis, Tennessee, 38105, United States

Zip Code: 38105
 

Record

SN03094804-W 20130622/130620234937-85056530bfa96627045142386d66d88b (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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