SOURCES SOUGHT
A -- Health Research & Development (Advisory)Development of Clinical Practice Guidelines
- Notice Date
- 7/17/2008
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Veterans Affairs, Bronx VAMC (NAL), Department of Veterans Affairs, Department of Veterans Affairs;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904
- ZIP Code
- 10468-3904
- Solicitation Number
- VA-243-08-RP-0331
- Response Due
- 7/25/2008
- Archive Date
- 9/23/2008
- Point of Contact
- Christina M. Katz, Contract Specialist
- Small Business Set-Aside
- N/A
- Description
- This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation notice nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of performing the work.Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Tax ID Number (g) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (h) must provide a capability statement that addresses the organizations qualifications and ability to perform in accordance of the Statement of Work. Description: See below for Statement of WorkImportant Information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The North American Classification System (NAICS) code for this acquisition is 541712 Health Research and Developmental Laboratories and Services. (Size standard: 500 employees)Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the Central Contractor Registration (CCR located on the web at www.ccr.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail, mail or ground carrier to: Dept. of Veterans Affairs, James J. Peters Medical Center, VISN 3/Network Acquisition and Logistics, #10N3-NAL-3, Bronx, NY 10468 or by e-mail to Christina.Katz@va.gov. All information submissions to be marked Attn: Christina Katz, Contracting Officer and should be received no later than 3:30 pm Eastern Standard Time on Thursday, July 29th, 2008. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published. The Governments intent is to solicit a Firm Fixed Price, Best Value Procurement.VA NEW YORK HARBOR HEALTHCARE SYSTEMSTATEMENT OF WORKESTABLISHMENT OF CLINICAL PRACTICE GUIDELINES FOR MUSCULOSKELETAL DISORDERS1.Introduction and Scope of WorkBack and Neck injuries produce a considerable amount of lost employee time in any organization. This project requires development and implementation of Clinical Practice Guidelines (CPGs) for the treatment of lower back and neck-related injuries, as well as research studies to determine the effectiveness of those CPGs. A Program Advisory board will be established consisting of the following:VA NYHHS STAFF:Principle CoordinatorProject CoordinatorOccupational Health Staff:Chief, Personnel Health, New York CampusWorkers' Compensation Program Manager, New York CampusChair, Ergonomics Program, Brooklyn CampusPhysical TherapistPsychologistData ManagerCONTRACT STAFF:Medical AdvisorPsychologistEpidemiologistResearch Physical TherapistAdvisory Board MembershipThis board will discuss the scope and content of the project, and reach consensus on the best way to implement the project. The project will be conducted in two phases. The first phase will encompass development of CPGs for Lower Back Pain and Neck-Related pain, based on evidence-based medicine combined with best practice recommendations, utilizing updated literature review, current evidence-based treatments (EBTs) and the experience of the contracted group. Implementation of these CPGs will take place in Phase II. Data will be collected during these phases to address research questions regarding the effectiveness of the CPG in terms of employee return to duty statistics.2.Requirementsa.Timeliness RequirementsAll components of the project will be completed within the 2008 and 2009 Fiscal Years.b.Reporting RequirementsProgress will be reported via the Program Advisory Board regarding the creation of CPGs, clinician training, implementation of the CPGs and subsequent research activities to validate the efficacy of the CPG to Senior Management, VA NYHHS.c.Documentation RequirementsA Manual of Operations and Procedures (MOOP) will be produced that will include recommendations for implementation, test batteries and evaluation protocols, algorithms for treatment, referral triage and supporting materials for patient and healthcare provider education. Additionally, a website will be developed which will include web-based training (as outlined in the MOOP). The treatment protocols contained in the MOOP will most likely include Clinical Examination and Evidence-Based Interventions (exercise, ergonomics and psychological). Once the MOOP is completed, reviewed and approved, it will provide a detailed plan for training healthcare providers and administrative staff in the procedures of clinical practice and data collection. A feasibility study will be provided at the completion of the training to evaluate ease of implementation and quality control. To accommodate Transfer of Knowledge, reports summarizing the CPGs and results from the pilot study will be submitted to NY Harbor Executive Management and VA Central Office.d.Workload DataThe CPGs will be utilized on all injured employees presenting to the Employee Health Services at the Brooklyn and New York campuses for Lower Back and Neck-Related Injuries in the six months following the implementation of the CPG intervention.e.Facility DataThe contractor will require access to Employee Health records in order to compare the period six months after the intervention of the CPGs with data from the six months previous. This will be accomplished once all VA Information Security and Privacy regulations have been met, as described in section j below.f.Place of PerformanceInitial meetings of the Program Advisory Board will take place at the VA NYYHS. Member research/individual work assignments can be performed at any location convenient for the Board Member. Phase II will be accomplished at the Employee Health Services at both the New York and Brooklyn campuses of VA NYHHS. Analysis of records for employee visits in the six months previous to the intervention of CPGs can be accomplished remotely, following all VA NYHHS Information Security and Privacy regulations. Physicians can complete their training remotely through the website mentioned in section c.g.Procedure for Referral and SchedulingEmployees presenting at the Brooklyn or New York campus of VA NYYHS will be evaluated and referred to the project by the Occupational Health Staff in the Employee Health Services.h.Transfer of PatientsNot applicablei.Employee SafetyThe current safety policy within the facility includes, but is not limited to, Environment of Care. See Section 3, References.j.Exchange of DataThe data compiled in this project is considered sensitive, containing personal information on VA NYHHS employees, and will be protected following all applicable VA Information Security and Privacy regulations, as listed in section 3, References.Contractor staff requesting access to employee records must complete Information Security training and Privacy training and evidence of the implementation of a background check. Additionally, consideration must be made to protect the data itself. The contractor must present a data exchange solution that will contain the data within the VA environment. The Research Checklist will be used to ensure that data is secured. Any and all applicable documents regarding protection of data/data exchange/release of information will be completed prior to IRB and R&D review.k.Billing: TBDl.Payments: TBDm.Penalty for Non-PerformanceNon-performance of the terms of this Statement of Work will result in termination of services.n.Reimbursement Method: TBDo.Educational and Research ActivitiesOnce the CPGs are defined, training will take place via the website mentioned in section c. The website will provide general information for all healthcare providers as well as specific topics for all specialists as outlined in the MOOP. The web-based program will offer a computer scored test section so that participants can track their progress and the effectiveness of the training can be assessed. The website will also facilitate communication and information exchange among healthcare providers. Upon approval of the MOOP, the contractor will provide a detailed plan for training VA healthcare providers and administrative staff in the procedures of clinical practice and data collection. This training will follow established training protocols and will include education sessions and practical training by the contracted staff. The Epidemiologist will work with a dedicated VA employee to set up and maintain a database for ongoing feedback and research. The database will be stored and managed in a secure VA-based website platform.Upon completion of the training, a feasibility study will be conducted to evaluate success of implementation and quality control. A subsequent pilot study will then be run to test the efficacy of the CPGs, implementing a concurrent, quasi-experimental, controlled trial. In this proposed trial, outcomes at the NY campus, using the CPGs will be compared with outcomes at the Brooklyn campus, using current practices. Approval of the protocol by the VA NYHHS IRB and R&D Committees will be required before the project can begin.The trial will be designed to test the following research questions:1.Compared to the control site, the intervention site will have a greater decrease in total days lost to injury in the six months following implementation of the intervention versus the same six month period in the previous year.2.Compared to the control site, the injured employees at the intervention site will have a shorter average recovery time (mean days out of work).3.Compared to the control site, injured employees at the intervention site will have a higher rate of return to full duty (lower rate of limited or light duty).4.Compared to the control site, injured employees at the intervention site will have greater satisfaction with the process and outcomes of care.5.Psychosocial and clinical characteristics of injured employees at initial presentation will predict time to recovery, return to full duty and satisfaction.The study population will be all injured employees presenting to Employee Health Services at the two study sites (clinical campuses at VA NYHHS) in the six months following implementation of the CPG intervention, compared with those presenting in the six month period before implementation. The same calendar period will be used in order to control for potential seasonal variation in occupational injury and recovery experiences.At the initial presentation to Employee Health Services for an occupational injury, all staff will complete a standardized questionnaire that addresses the nature of the injury and symptoms, their demographic characteristics, and a psychological profile using validated instruments that have been linked to outcomes in musculoskeletal injury.Employees at the Brooklyn campus will be evaluated and managed based on current policies and strategies, at the discretion of the clinical staff. At the New York campus, evaluation and management will be guided by the CPG and relevant training implemented in the pilot.The outcome variables to be collected and analyzed are:Total days lost to work due to injury over six months (two quarters) at each site. This data is routinely collected at VA in the ASSIST database and reported in aggregate, sorted by clinical campus, to the Safety Committee.Total days lost to work due to injury over the same six months (two quarters) period in the previous calendar year at each site.Recovery time: number of days lost to injury for each injured employee during the first six months following implementation. This outcome is tracked by Employee Health Service staff at each campus by clinical or telephone follow-up with injured employees. Time to return to work will be confirmed with each employee's supervisor.Return to full duty following injury: Work status (full, limited, or light duty) at three and six months following injury will be tracked by Employee Health Service staff at each campus by clinical or telephone follow-up with injured employees. Work status will be confirmed with each employee's supervisor.Satisfaction: Satisfaction with the process and outcomes of care will be assessed via questionnaire among all injured employees at each campus, six months following initial presentation for injury.The Analysis Plan will test the five hypotheses:Hypothesis #1 will be tested by analysis of covariance, comparing total days lost to work due to injury at intervention vs. control sites, adjusted for differences in baseline rates in the prior year. A paired t-test will also be used to compare change in total days lost to work at intervention vs. control sites.Hypothesis #2 will be tested using t-tests to compare mean days out of work at intervention vs. control sites.Hypothesis #3 will be tested using chi-square tests to compare the rate of return to full duty (vs. limited or light duty) at intervention vs. control sites.Hypothesis #4 will be assessed using chi-square and t-tests as appropriate to the data to compare satisfaction at intervention vs. control sites.Hypothesis #5 will be assessed using multivariate regression models of baseline characteristics predictive of time to recovery, return to full duty, and satisfaction. Predictive variables will be considered for the regression models based on the strength of their bivariate association with each outcome (p<0.1 required for consideration). Linear and logistic regression will be used as appropriate to the nature of the outcome being modeled.The major threats to validity in this trial will be the non-blinded nature of the intervention, and outcome assessment. The impact of potential measurement bias will be limited by the objective nature of most of the outcome variables. The primary outcome, total days lost to work, will be assessed via administrative data collected independently of allocation status. In addition, work status outcomes will be confirmed with employee's supervisors. Selection bias will be limited by adjusting comparisons of outcomes by differences in baseline variables (employee characteristics) and by historical rates for hypothesis #1.The return on investment (ROI) of the intervention will be assessed by determining the ratio of incremental cost to incremental efficacy in reduced time lost to work at intervention compared with control sites (dollars per day saved). If the proposed intervention is efficacious, the ROI analysis will help justify scaling up the program for larger-scale testing of effectiveness at more sites (for example, across an entire VISN)3.References a.VA NYHHS Policy 00-1, Automated Information Securityb.VA NYHHS Policy 136-15, Privacy and Release of Informationc.VA NYHHS Policy 00C-10, Environment of Cared.VA Directive 6500, Information Security Programe.VA Directive 6504, Restriction on Transmission, Transportation and Use Of, and Access To, Data Outside VA Facilitiesf.VA Handbook 1605.1, Privacy and Release of Informationg.VA Handbook 1605.2, Minimum Necessary Standard for Protected Health Information.4.Delivery: The deliverables contain but are not limited to the following:a.Creation of a Program Advisory Boardb.Creation of Clinical Practice Guidelines for Back Painc.Creation of Clinical Practice Guidelines for Neck Paind.Training of VA clinicians regarding the approved Clinical Practice Guidelinese.Evaluation of the effectiveness of the approved Clinical Practice Guidelines via Employee Health record review as described above.5.Progress and ComplianceVA NYHHS Senior Management and VA NYHHS staff participating in the study must be updated regarding progress during all phases of the project, based upon the plan/schedule created by the Program Advisory Board.The COTR for the contract (VA employee) will also be kept updated regarding progress, documentation and deliverables. 6.Notes and Other InformationThe contractor may be asked to provide alternate solutions in the areas of Information Security, Privacy and Research Compliance in the event that VA regulations change during the course of the contract.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=a5ac7d45718b0cf5b9ef69d56ed4b777&tab=core&_cview=1)
- Place of Performance
- Address: NY Harbor Healthcare System;Manhattan and Brooklyn Campus;423 East 23rd St.;New York, NY
- Zip Code: 10010
- Zip Code: 10010
- Record
- SN01616622-W 20080719/080717221153-a5ac7d45718b0cf5b9ef69d56ed4b777 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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