Capability_Sources_Sought_2016-N-17729.docx

Draft 1/27/16 - 7

*********************************MARKET RESEARCH ONLY*********************************

INTRODUCTION

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations, AND IS FOR MARKET RESEARCH ONLY.

The purpose of this notice is to obtain information regarding the availability and capability of qualified business sources relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

The anticipated NAICS code for this are the following:

· 541711 Biotechnology research and development laboratories or services in health sciences

· 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) (small business defined as 500 employees or less)

· 541940 Veterinary Services

· 611310 Colleges, Universities, and Professional Schools (small business defined as $27.5 Million in average annual receipts)

· 621492 Kidney Dialysis Centers

· 622110 General Medical and Surgical Hospitals (small business defined as $38.5 Million in average annual receipts)

· 623110 Nursing Care Facilities (Skilled Nursing Facilities) (small business defined as $27.5 Million in average annual receipts)

· 623312 Assisted Living Facilities for the Elderly (small business defined as $11Million in average annual receipts)

BACKGROUND

The purpose is in support of Healthcare-associated infections (HAI) prevention research studies that meet public health priorities for CDC.

CAPABILITY STATEMENT/INFORMATION SOUGHT

Interested businesses must respond to all of the following:

1. Provide a capability statement of your firms ability to perform services under Domains 1-8.

2. Identify which domains you are capable of performing by providing the no. and domain title.

3. Provide responses to Kimberly Golden @KGolden1@cdc.gov.

Proposed SHEPheRD IDIQ Domain Structure This IDIQ will be divided into eight functional domains: 1) Healthcare-associated infection (HAI) and Other Adverse Healthcare Event Prevention Research Protocol Development and Implementation, 2) Acute Inpatient Care Quality Improvement and Research Implementation Infrastructure, 3) Long Term Acute Care/Long Term Care Quality Improvement and Research Implementation Infrastructure, 4) Dialysis Center Quality Improvement and Research Implementation Infrastructure:, 5) Healthcare Information Technology Development, Implementation, and Services , 6) Advanced Molecular Epidemiology and Microbial Community Analysis , 7) International HAI and Other Adverse Healthcare Event Prevention Research, and 8) Veterinary Healthcare Quality Improvement and Research Protocol Development and Implementation. Where applicable, Contractors may compete to participant under a single or multiple domains. If selected for inclusion in the IDIQ, each vendor will receive a minimum guarantee for participation.

1 - HAI and Other Adverse Healthcare Event Prevention Research Protocol Development and Implementation:

Vendors under this domain are expected to have substantial experience in the field of human healthcare epidemiology, with an emphasis on the epidemiology of HAIs, antibiotic resistance, and healthcare safety. Vendors must have demonstrated the capacity to initiate and lead multiple steps across the spectrum of scientific inquiry including formulating a research question, developing a detailed epidemiological and prevention research plan and protocol, and successfully implementing the protocol, analyzing and interpreting results, and leading publication of the findings in peer reviewed literature. Specifically, given a specific healthcare epidemiology-related research question posed by the funding agency, the vendor should have the capacity to propose an approach to successfully answering the question, including but not limited to study design, protocol development, database development, statistical support, background literature review, study implementation, data management and analysis. Expertise in clinical trial design, including statistical expertise in complex power calculations involving clustered designs and analyses, is an advantage. Vendors in this domain need not necessarily have access to the healthcare settings and patient populations sufficient for implementing the protocols they develop. In some situations, the vendor may be asked to design protocols for implementation in healthcare settings and systems selected by CDC that are not directly affiliated with their home or partner institutions, or with which they may have had no prior collaborative experience. In these situations, the vendor will be required to maintain a leading role in coordinating and overseeing the implementation of the study, as well as leading the analysis, interpretation, and publication of the findings.

1. Research design and planning

2. Scientific and technical support for research design and planning

3. Protocol development and pilot testing

4. Data system development and implementation

5. Data modeling, management, analysis, and informatics

6. Preparation of OMB and IRB packages as required

2 - Acute Inpatient Care Quality Improvement and Research Implementation Infrastructure:

Vendors under this domain will provide access to a clinical network comprised of acute care and outpatient facilities within which single- and multi-center quality improvement and/or research projects can be implemented. It is anticipated that the networks will implement HAI and other adverse event prevention quality improvement or research study protocols provided by the funding agency. Contractors should be, or have direct access to, multicenter networks comprised of at least 10 acute care healthcare hospitals, in addition to associated outpatient facilities. CDC will be seeking vendors having access to networks of acute healthcare facilities having the following characteristics:

· Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

· Demonstrated ability to recruit healthcare facilities and patients within the network to participate in quality improvement or research initiatives, preferably related to prevention of HAIs or other adverse events related to healthcare, or related to other patient safety issues.

· Demonstrated ability to oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources. Having experience preparing and submitting IRB and OMB packages is preferred, as is having a single Centralized Institutional Review Board (IRB) capacity for the entire network of facilities.

· Demonstrated flexibility in extracting data for tailored requests for clinical information (i.e., have demonstrated capacity to generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

· Preference will be given to vendors who are, or have direct access to, large networks that are operated by a common entity, and in which administrative and policy decisions related to infection prevention and information technology, as well as other management decisions are made centrally on behalf of the entire network and are implemented uniformly across all facilities in the network.

Vendors in this domain need not have the capacity to develop research or quality improvement project plans and protocols. Research and quality improvement protocols will be provided by CDC, and the vendor will implement the protocol. It is expected that the leading role in coordinating and overseeing the implementation and evaluation of the protocol will be actively shared with CDC and/or its collaborating partners. The vendor will be offered the option of participating in authorship of publications resulting from such studies; CDC and/or one of its collaborating partners will play the leading role in analysis, interpretation, and publication of the findings.

Preference will be given to those vendors with well-defined existing networks and not those with newly established subcontracted relationships.

1. Provide access to integrated electronic medical systems and population based outcomes in inpatient and outpatient facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion are preferable

3 - Long Term Acute Care/Long Term Care Quality Improvement and Research Implementation Infrastructure:

Vendors under this domain will provide access to a clinical network comprised of either acute long term care hospitals, skilled nursing facilities, or both, within which single- and multi-center quality improvement and/or research projects can be implemented. It is anticipated that the networks will implement HAI and other adverse event prevention quality improvement or research study protocols provided by the funding agency. Contractors should be, or have direct access to, multicenter networks comprised of either or both of the following: 1) at least 10 long term acute care healthcare hospitals, 2) at least 10 skilled nursing facilities. CDC will be seeking vendors having access to networks of long term acute care or skilled nursing facilities having the following characteristics:

· Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

· Demonstrated ability to recruit healthcare facilities and patients within the network to participate in quality improvement or research initiatives, preferably related to prevention of HAIs or other adverse events related to healthcare, or related to other patient safety issues.

· Demonstrated ability to oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources. Having experience preparing and submitting IRB and OMB packages is preferred, as is having a single Centralized Institutional Review Board (IRB) capacity for the entire network of facilities.

· Demonstrated flexibility in extracting data for tailored requests for clinical information (i.e., have demonstrated capacity to generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

· Preference will be given to vendors who are, or have direct access to, large networks that are operated by a common entity, and in which administrative and policy decisions related to infection prevention and information technology, as well as other management decisions are made centrally on behalf of the entire network and are implemented uniformly across all facilities in the network.

Vendors in this domain need not have the capacity to develop research or quality improvement project plans and protocols. Research and quality improvement protocols will be provided by CDC, and the vendor will implement the protocol. It is expected that the leading role in coordinating and overseeing the implementation and evaluation of the protocol will be actively shared with CDC and/or its collaborating partners. The vendor will be offered the option of participating in authorship of publications resulting from such studies; CDC and/or one of its collaborating partners will play the leading role in analysis, interpretation, and publication of the findings.

1. Provide access to integrated electronic medical systems and population based outcomes in long term acute/long term facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion are preferable

4 - Dialysis Center Quality Improvement and Research Implementation Infrastructure:

Vendors under this domain will provide access to a clinical network comprised of dialysis centers within which single- and multi-center quality improvement and/or research projects can be implemented. It is anticipated that the networks will implement HAI and other adverse event prevention quality improvement or research study protocols provided by the funding agency. Contractors should be, or have direct access to, multicenter networks comprised of at least 20 dialysis facilities having the following characteristics:

· Common information technology infrastructures within which clinical data routinely generated during the course of patient care across multiple facilities is collected and stored in a central location using common data format and structure, and is accessible through a central point of contact within the network.

· Demonstrated ability to recruit healthcare facilities and patients within the network to participate in quality improvement or research initiatives, preferably related to prevention of HAIs or other adverse events related to healthcare, or related to other patient safety issues.

· Demonstrated ability to oversee all aspects of implementation of quality improvement projects or clinical research studies pertaining to prevention of HAIs, including providing access to personnel to staff projects and other necessary material resources. Having experience preparing and submitting IRB and OMB packages is preferred, as is having a single Centralized Institutional Review Board (IRB) capacity for the entire network of facilities.

· Demonstrated flexibility in extracting data for tailored requests for clinical information (i.e., have demonstrated capacity to generate custom data extractions, not just “canned” report structures that are embedded within a proprietary health information system).

· Preference will be given to vendors who are, or have direct access to, large networks that are operated by a common entity, and in which administrative and policy decisions related to infection prevention and information technology, as well as other management decisions are made centrally on behalf of the entire network and are implemented uniformly across all facilities in the network.

Vendors in this domain need not have the capacity to develop research or quality improvement project plans and protocols. Research and quality improvement protocols will be provided by CDC, and the vendor will implement the protocol. It is expected that the leading role in coordinating and overseeing the implementation and evaluation of the protocol will be actively shared with CDC and/or its collaborating partners. The vendor will be offered the option of participating in authorship of publications resulting from such studies; CDC and/or one of its collaborating partners will play the leading role in analysis, interpretation, and publication of the findings.

1. Provide access to integrated electronic medical systems and population based outcomes in dialysis facilities.

2. Provide access to clinical data, including administrative data from a large number of healthcare institutions that collect data in a standardized fashion are preferable

5 - Healthcare Information Technology Development, Implementation, and Services:

Vendors in this domain are vendors of proprietary electronic healthcare record systems or other healthcare information technology products or services who can work collaboratively with CDC to (1) review the National Healthcare Safety Network (NHSN) reporting protocols HAIs and other adverse healthcare events, i.e., protocols in use and under development, in terms of their operational fit with current healthcare information technology architectures, platforms, and databases, (2) recommend to NHSN SMEs or Business Analysts modifications to data requirements for both existing and future definitions to best leverage pre-existing electronic data in Electronic Health Record (EHR) systems or other information used in healthcare, and, (3) accelerate implementation and provide technical support for electronic reporting solutions that enable healthcare facilities to submit HAI and other adverse healthcare event data to CDC.

1. Provide expertise in healthcare data surveillance and management.

2. Provide access to surveillance data of large healthcare systems, specifically sites reporting to National Healthcare Safety Network (NHSN).

3. Provide access to and established relationships with tertiary care facilities, including long term care, nursing home, pediatric care, outpatient care, and dialysis centers

6 - Advanced Molecular Epidemiology and Microbial Community:

Vendors in this domain must have substantial experience and capacity to perform complex molecular procedures including but not limited to:

1. Performing generation of next-generation sequence data

2. Laboratory analysis of molecular mechanisms of resistance and other strain characteristics

3. Identification of known antimicrobial resistance determinants, strain characteristics, and genomic sequences of public health importance from genomic data

4. Analyzing genomic data to determine strain relatedness and assess transmission dynamics in a variety of healthcare

5. Performing metagenomics community analysis of patient specimens and/ or environmental samples to describe the community composition and complexity, presence of known antimicrobial resistance determinants, and presence of established virulence determinants

1. As related to performing complex molecular procedures:

a. Providing access to facilities and/or laboratories, including in diverse geographic locations.

b. Providing access to laboratory capabilities and current infrastructure to conduct isolate collection, storage and shipping.

c. Ability to obtain rare isolates by organism as needed

7 - International HAI and Other Adverse Healthcare Event Prevention:

Vendors under this domain will provide access to clinical infrastructures in low and or middle income countries within which single- or multi-center research study protocols can be implemented. Vendors under this domain are expected to have substantial experience with the mechanisms of healthcare delivery in low and middle income countries, and have demonstrated success in conducting research within these settings. Vendors will also have established relationships with relevant in-country partners (e.g., Ministry of Health, local research institutes/universities).

1. Address international healthcare epidemiology research design tasks, such as:

a) Assess the cost-effectiveness of infection prevention and control practices in low and middle income countries.

b) Assess the impact of improved antimicrobial resistance testing/antibiograms on clinical/hospital-level prescribing practices in low and middle income countries

2. Address international healthcare epidemiology prevention research implementation and evaluation tasks, such as:

a) Ability to evaluate the impact of infection control improvements on healthcare associated infection or associated metrics in resource limited countries.

b) Design and/ or evaluate strategies to measure antimicrobial use in low and middle income countries.

c) Demonstrated ability to evaluate the impact of antimicrobial stewardship activities on antimicrobial resistance or associated metrics in resource limited countries.

3. Address international healthcare surveillance research and development, such as:

a) Assess the burden of healthcare associated infections in low and middle income countries via longitudinal or point prevalence methodology.

b) Assess antimicrobial use and prevalence of antimicrobial resistance in low and middle income countries via longitudinal or point prevalence methodology.

8 - Veterinary Healthcare Quality Improvement and Research Protocol Development and Implementation:

Vendors under this domain are expected to have substantial experience in the field of animal healthcare or animal healthcare epidemiology. Vendors must have demonstrated the capacity to initiate and lead quality improvement projects and/or multiple steps across the spectrum of scientific inquiry including formulating a research question, developing a detailed plan and protocol designed to address the question, including epidemiological and prevention research plans and protocols, and successfully implementing the protocol, analyzing and interpreting results, and leading publication of the findings in peer reviewed literature if appropriate. Specifically, given a specific healthcare epidemiology-related research question or quality improvement strategy posed by the funding agency, the vendor should have the capacity to propose an approach to successfully answering the question or implementing the quality improvement strategy, including but not limited to study design, protocol development, database development, statistical support, background literature review, study implementation, data management and analysis. Expertise in clinical study design is an advantage.

1. Develop nationally representative data sets related to the use of antibiotics in companion animal and other veterinary settings;

2. Perform data analysis on these data sets related to antibiotic use in companion animal and veterinary settings;

3. Perform Sentinel Surveillance of antibiotic resistant bacteria

4. Develop Recommendations to inform Antibiotic Stewardship Guidelines for Veterinary Practices