SOURCES SOUGHT
B -- Clinical Decision Support for Working Patients with Diabetes Mellitus in a Primary Care Clinical Setting. - Diabetes and Work Environment CDS Knowledge
- Notice Date
- 2/2/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070, Cochrans Mill Road, Pittsburgh, Pennsylvania, 15236-0070
- ZIP Code
- 15236-0070
- Solicitation Number
- HHS-CDC-NIOSH(DM)-SBSS-16-002
- Archive Date
- 3/2/2016
- Point of Contact
- Diane J Meeder, Phone: (412)386-4412
- E-Mail Address
-
DMeeder@cdc.gov
(DMeeder@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Diabetes and Work Environment CDS Knowledge This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Center for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), is seeking information on a potential requirement for "Clinical Decision Support for Working Patients with Diabetes Mellitus in a Primary Care Clinical Setting." The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the NAICS code 541990 for the potential acquisition. Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. DRAFT Sample Work Statement (subject to change); Project Objective To evaluate the implementation, use, and perceived value of integrated clinical decision support (CDS) in a primary care setting that addresses management of diabetes mellitus in patient work environments. • To assess the usefulness of the CDS to clinicians (herein defined as primary care providers and other clinical staff), patients, and the healthcare organization • To assess ease of use, tolerability of the CDS • To improve the CDS based on lessons learned • To assess changes in attitudes and behavior of clinicians in response to the CDS over time, in order to determine if favorable changes are sustained over time; for example: o Changes in the perceived relationship between work and health among clinicians before and during the availability of the CDS o Changes in use of occupational information in clinical practice (beyond diabetes) before and during the availability of the CDS • To assess patient receptiveness to receiving information about the impact of their work environment on their health management, in order to improve their care • To assess changes in patient HbA1c levels before and during the availability of the CDS (if feasible) • To assess the impact of the CDS on patient behaviors Background This project aims to demonstrate the value and meaningful use of occupational information in electronic health records (EHRs) by providing clinical decision support (CDS) to clinicians to facilitate their recognition of the interface of work and health. EHR systems use CDS applications/tools to provide care providers and other clinical staff, patients, and/or other individuals with knowledge to enhance health and health care. Standardized data, including data from a person's occupational history, can be used to trigger delivery of information relevant to care. To date there has been no systematic assessment of the feasibility and usefulness of delivering clinical information linked to work through the EHR. A major challenge to CDS software developers is how to convert clinical knowledge, such as treatment guidelines, into a computer interpretable format. To address this challenge and to accomplish our goals, NIOSH is using a stepwise approach which uses a four-stage or four-layered framework. The bottom layer expresses the knowledge in broad narrative language and higher layers increasingly adding more technical structured detail focused on a specific clinical context and EHR. The occupationally relevant knowledge and logic (bottom layers) is provided in the Diabetes_and_Work_Environment_CDS_Knowledge document and the work reflected herein is to demonstrate its usability and usefulness within a specific clinical setting (higher layers). Dissemination of the knowledge gained by this work will target a variety of audiences ranging from EHR policy makers to producers and users of EHRs. The HHS Office of the National Coordinator for Health Information Technology (ONC) drives the implementation of certified EHRs in the U.S. and the Centers for Medicare and Medicaid (CMS) provide substantive financial incentives for meaningful use of EHRs through regulatory channels. Disseminating the results of this work to health care entities, EHR and CDS vendors, and researchers studying the application of health information technology (HIT) will build support for broader use of this and similar CDS relating health and work in EHRs. The target population for this study is primary care practitioners, who often are faced with caring for patients whose work environment impacts their health management. Patients spend a significant portion of their day at their workplace and therefore comprehensive and coordinated care requires consideration of work-related factors. A key aspect of healthcare improvement through the use of HIT is the delivery of knowledge via the EHR to educate and advise patients and clinicians on clinical management options. CDS tools supply clinicians, patients, or other individuals with knowledge to enhance health and health care. Standardized data, including data from a person's occupational history, can be used to trigger user-friendly delivery of information relevant to care, such as clinical guidelines. The content can be intelligently filtered using person-specific information and presented at appropriate times during the clinical care process. Educating patients and clinicians about work-related risk factors at the time of care will reinforce prevention and promote better care of working patients. Diabetes is an example of a chronic disease for which work environment factors can impact disease management. Among all workers, age 18 or older, 4% reported ever being told by a health care provider they have diabetes and among adults aged 44-64, 13.7% have either diagnosed or undiagnosed diabetes. Davila et al. found that adults working over 40 hours per week were more likely to have suboptimal glycemic control (HbA1c level) compared to those working 20 hours or less and hypothesized that factors such as time constraints and the negative impact of shift work on diet could explain these findings. Also, physical activity levels, both work-related and leisure-time, vary considerably across occupations and may contribute to achieving optimal glycemic control. Finally, a number of studies have systematically examined the efficacy of EHRs and CDS to improve diabetic control and have found that these can contribute to positive changes in clinician performance and glycemic control, especially among patients who previously had greater difficulty with control. It is possible that the work environment could be one of the contributing factors to poorer control. The American Diabetic Association has created guidelines to assist physicians regarding disability and work accommodations for their diabetic patients. Scope The contractor is to evaluate the viability of using work information to improve clinical management in a primary care setting, based on performance measures and, if possible, on health outcomes. The contractor is to apply information from the Diabetes_and_Work_Environment_CDS_Knowledge document to clinical decision support (CDS) in a primary care clinical entity and evaluate the use and attitudes by clinicians (herein defined as primary care providers and other clinic staff) over time. The contractor is to structure the information and logic to address each patient encounter, based on the description in the knowledge document and their knowledge of primary care settings. The principles for this work are described in Mardon et al (ref. 11). The detailed, semi-structured model of the information and decision logic for the selected application that is present in the Diabetes_and_Work_Environment_CDS_Knowledge document and as modified by the contractor, is to be converted into a structured, computer-usable language model consistent with required EHR system standards. The contractor is to prepare the model with the correct technical terminology (i.e., HIT vocabulary codes) and CDS software standards. This structured model is to incorporate data standards and technical requirements that are independent of site-specific considerations such that it potentially could be used in most EHR systems. The contractor is to prepare educational materials that are suitable to their primary care clinical environment and relevant patient population, i.e., clinicians involved in the care of diabetic patients, and working patients with uncontrolled diabetes. The materials are to convey the knowledge provided in the Diabetes_and_Work_Environment_CDS_Knowledge document and can also include knowledge from other, reliable sources. The contractor is to translate the structured model into technical requirements that can become part of the instructions to an implementation team to create or modify CDS software. The contractor is to combine the requirements derived from the model with SME input, site-specific workflow, CDS delivery-tool, and EHR system and CDS software requirements to prepare site-specific technical requirements. The contractor is to use the site-specific technical requirements to instruct the modification of CDS software available at the clinical entity to implement the information and logic of the CDS. The contractor is to evaluate the implementation and use of the CDS as it facilitates care at the interface of work and health. The evaluation is to provide data (qualitative and quantitative) to achieve the objectives stated above. Additional objectives as desired by the clinical entity also may be incorporated. The contractor shall use recognized best practices to perform the following activities related to the planning and implementation of the CDS in their clinical environment, collection of evaluation data by an unbiased/independent party, and CDS tool adjustments as needed based on evaluation data collected during the project: • Detailed initiation, planning, and development o Requirements-gathering from NIOSH SMEs, relevant system vendor(s), and internal clinicians o CDS design that incorporates usability principles, best practices, and common standards o Development of the CDS and the reports o Usability and quality assurance testing of the CDS o User acceptance testing of the CDS, both for content acceptance and system use o Preparation of educational materials • Implementation of the CDS o Clinician training in the use of the CDS tool o Clinician training on the content and value of the CDS information o Deployment of the CDS o Monitoring and maintenance; addressing issues with the CDS, if needed o Addressing issues with educational materials, if needed • Evaluation of the CDS o Performance measurement of the CDS  Qualitative assessment of the CDS based on user and patient interviews  Quantitative (process) assessment of the CDS based on data acquired through reports generated using available electronic health information system(s) o Health outcome measurement, if possible o Analysis of the performance and health outcome measurement data collected o Lessons learned in development and implementation Anticipated period of performance. Approximately twenty-six (26) months. Other important considerations. Human Subjects Institutional Review Board (IRB) Approval Work with human subjects shall not begin until the project protocol has been approved by the NIOSH IRB. Planning for IRB approval shall take into consideration the frequency of IRB review meetings and schedule accordingly. Note that the NIOSH IRB meets once a month. The contractor shall, in a timely fashion: • Provide a thorough and complete proposed protocol (including evaluation tools) to assist NIOSH with obtaining IRB approval. • Prepare a final, complete protocol based on input from NIOSH staff and the IRB review process. • Obtain internal IRB approval if required by their organization. Capability statement /information sought. Respondents who believe that they possess the expertise and experience to meet the government's needs as described above are invited to submit technical and management capabilities addressing those requirements. These may include but are not limited to: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Respondent must indicate in your capability statement: - Organization name, - Address, - DUNS number, - Business size Classification (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code of 5411990 size standard which is $15 million. - Points of contact, - Email, - Telephone number. Page Limitation: No more than five (5) pages, 8 ½ x 11. Response Due Date: Submit information above to Diane J Meeder, Contract Specialist, CDC, NIOSH, 626 Cochrans Mill Road, Pittsburgh PA 15236, DMeeder@cdc.gov. Reference: HHS-CDC-NIOSH(DM)-SBSS-16-002. Responses are due no later than 3:30pm, February 16, 2016 Eastern Time. Any information received by the government will not be returned. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be posted on Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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