1 0 1 1 The Department Of Defense Dod Defense Health Agency Dha Is Issuing This Request For Information As A Means Of Conducting Market Research To Support The Requirements To Provide The Public Health Division Phd Immunization Healthcare Division Ihd Support For Vaccine Safety And Evaluation Studies As Well As Management Of The Related It Health Systems Applications This Is In Accordance With The Federal Acquisition Regulation Far Part 10 The Result Of This Market Research Will Assist In Understanding Market Capability And Resources The Applicable North American Industry Classification System Naics Code Assigned To This Procurement Is 541611 Administrative Management And General Management Consulting Services 1 2 This Is A Request For Information Rfi Only This Rfi Is Issued Solely For Information And Planning Purposes It Does Not Constitute A Request For Proposal Rfp Or A Promise To Issue An Rfp In The Future This Request For Information Does Not Commit The Government To Contract For Any Supply Or Service Whatsoever Further The Dha Is Not At This Time Seeking Quotes Or Proposals And Will Not Accept Unsolicited Proposals Respondents Are Advised That The U S Government Will Not Pay For Any Information Or Administrative Costs Incurred In Response To This Rfi All Costs Associated With Responding To This Rfi Will Be Solely At The Interested Party S Expense Not Responding To This Rfi Does Not Preclude Participation In Any Future Rfp If Any Is Issued If A Solicitation Is Released It May Be Synopsized On The Beta Sam Gov Website Or Solicited Through Other Government Points Of Entry Such As Gsa Ebuy For Pss Schedules Oasis Etc It Is The Responsibility Of The Potential Offerors To Monitor All Sites For Additional Information Pertaining To This Requirement The Government Will Evaluate Market Information To Ascertain Potential Market Capacity To 1 Provide Services Consistent In Scope And Scale With Those Described In This Notice And Otherwise Anticipated 2 Secure And Apply The Full Range Of Corporate Financial Human Capital And Technical Resources Required To Successfully Perform Similar Requirements 3 Implement A Successful Project Management Plan That Includes Compliance With Program Schedules Cost Containment Meeting And Tracking Performance Hiring And Retention Of Key Personnel And Risk Mitigation And 4 Provide Services Under A Performance Based Service Acquisition Contract Based On The Responses To This Notice And Appendices This Requirement May Be Set Aside For Small Businesses Or Procured Through Full And Open Competition And Multiple Awards May Be Made Telephone Inquiries Will Not Be Accepted Or Acknowledged And No Feedback Or Evaluations Will Be Provided To Companies Regarding Their Submissions 2 0 Background The Ihd Supports The Dod Immunization Programs Protecting Military Service Members And Eligible Beneficiaries And Supports Education Training And Clinical And Epidemiologic Studies Of Vaccine Safety And Effectiveness The Ihd Vision Mission And Strategic Goals Are As Follows Ihd Vision Commitment To Provide And Enable The Best Quality And Responsive Patient Centered Immunization Healthcare Which In Turn Greatly Augments Readiness Ihd Mission To Enhance The Military Health System Mhs Focus On Health And Healing By Supporting Immunization Program Efficacy Safety And Acceptability Enabling Solutions That Address Personalized Medicine And Improved Evidence Based Practices Ihd Strategic Goals Synchronize Integrate And Coordinate Dod Services Vaccine Policies And Information Promote Excellence In Immunization Standards Of Practice Provide Dynamic And Responsive Expert Clinical Consultation Services Supporting Quality Immunization Policy And Practice Advocate For Evidence Based Practice Improvements In Immunization Healthcare Deliver Best Quality Immunization Healthcare Information Educational Resources Tools And Training Services Support Enhanced Population Vaccine Safety Surveillance Amp Research Develop And Implement Communication Strategies And Activities Contribute To The Body Of Knowledge In Immunization Healthcare Through Investigations Surveillance And Clinical Research Per The Listing Above One Of The Strategic Goals Of The Ihd Is To Contribute To The Body Of Knowledge In Immunization Healthcare Studies In Support Of All Dod Beneficiaries Specifically The Vaccine Safety And Evaluation Section Vse Promotes Quality Improvements In Immunization Healthcare Through Public Health Investigations Surveillance Epidemiologic Projects And Clinical Studies The Vse Manages Funding For External Studies And Also Internally Conducts A Portfolio Of Clinical Investigations To Improve Vaccine Safety And Effectiveness The Ihd S Role In Enhancing Vaccine Safety Surveillance And Improved Clinical Study Methods Continues To Expand The Ihd Has Identified And Leveraged Various Clinical Investigations Opportunities And Must Have The Ability To Easily Modify Expand Decrease Its Current Contract Staffing In Order To Complete Both New And Ongoing Clinical Studies Projects Studies Will Address Multiple Vaccines Including For Example Anthrax Smallpox Yellow Fever And Influenza Vaccines And Potentially Newly Licensed Vaccines Reflecting The Complex Mixtures Of Vaccines Delivered To Service Members Currently Studies Are Taking Place At All Ihd Regional Vaccine Safety Hubs Rvshs At The Following Military Treatment Facilities Walter Reed National Military Medical Center Wrnmmc At Bethesda Md Womack Army Medical Center Wamc At Fort Bragg Nc Wilford Hall Medical Center Whmc San Antonio Tx And Naval Medical Center San Diego Nmcsd San Diego Ca Studies Are Also Proposed At Such As Carl R Darnall Army Medical Center Fort Hood Tx Where The Ihd Has A Satellite Site As Well As Other Military Medical Facilities Inclusive Of Army Air Force Navy And Marine Corps Facilities To Enroll Service Members And Their Beneficiaries Vaccine Safety And Evaluation Studies Hold Enormous Potential For Improving The Quality Of Care And Reducing The Rate And Severity Of Adverse Events Following Immunization For Example Efforts To Understand Genetic Risk Factors For More Serious Adverse Events Like Myocarditis After Smallpox Vaccine Or Encephalitis As Well As Other Immune Mediated Neurologic Events Have Not Been Adequately Resourced Benefits Of Such Studies Also Include Improved Quality Of Life For Those Who Are Adversely Impacted By Immunization Reduced Healthcare Costs Reduction Of Disease Rates Through Increased Vaccination Rates And Increased Acceptability Of Vaccine Programs 3 0 Requested Information Companies Vendors That Provided Vaccine Safety And Evaluation Studies And Management Of The Related It Health Systems Applications Support Services As Described Below In Responding To This Rfi Please Indicate The Organization S Capabilities That Address The Government Requirements Requirements Provide Support Services In The Areas Of Protocol Development Regulatory Approval And Sustainment Subject Recruitment And Enrollment Data Entry And Quality Control Data Management Abstraction And Validation Statistical Analyses Biospecimen Processing Shipment And Storage And Generation Of Publications And Presentations In Support Of Clinical Investigations Projects Related To The Safety Acceptability And Effectiveness Of Immunizations Within The Military And Beneficiary Population Additional Support Services Include Development And Implementation Of Healthcare Related Information Management Systems Equipment And Services And Systems Design For Data Capture Generated By Clinical Investigations All Study Activities Will Be Performed In Strict Accordance With Applicable Protection Of Human Subjects Regulations And All Clinical Investigations Records Will Be In Compliance With Applicable Regulations And Institutional Review Board Approved Clinical Investigations Protocols 3 1 Clinical Investigations Projects Support 3 1 1 Recruitment And Enrollment Contractor Shall Recruit Potential Study Subjects And Determine Initial Eligibility For Participating In Study Protocols Contractor Shall Enroll Subjects In Clinical Studies Protocols Contractor Shall Review And Obtain Informed Consent From The Subjects Prior To Enrollment In The Clinical Investigations Protocol Contractor Shall Coordinate And Conduct Study Subject Visits And Assure All Procedures Are Conducted In Compliance With The Clinical Study Protocol 3 1 2 Specimen Collection And Handling Contractor Shall Obtain Specimens Via Venipuncture And Other Methods As Required Per Study Protocols Contractor Shall Perform Vital Signs And Other Necessary Clinical Procedures As Dictated By Clinical Investigations Protocols Contractor Shall Perform Specimen Handling And Processing To Include But Not Limited To Drawing Blood Obtaining Saliva Samples And Storing And Or Shipping Such Samples To External Collaborators As Required Per Study Protocols Contractor Shall Obtain Laboratory Testing As Required Contractor Shall Maintain Inventory Of Clinical Investigations Project Specimens And Detailed Audit Tracking Of The Movement Of Specimens 3 1 3 Adverse Events Contractor Shall Inform Principal Investigator And Or His Her Designee Of Abnormal Testing Values Or Other Issues Requiring Attention And Facilitate Subject Follow Up Contractor Shall Also Inform Principal Investigator And Or His Her Designee Of Any Expected Or Unexpected Reportable Events And Proceed With The Reporting Plan As Required By The Irb Of Record 3 1 4 Statistical Analyses Contractor Shall Contribute To Design Of Statistical Analyses And Complete Statistical Power Calculations To Determine Study Enrollment Targets Contractor Shall Implement These Analyses For Clinical And Epidemiologic Vaccine Safety Acceptability And Effectiveness Studies Contractor Will Write And Execute Sas Programs To Extract Combine And Manage Datasets And Perform Data Analyses 3 2 Secure Maintenance Of Clinical Investigations Project Records 3 2 1 Contractor Shall Securely Maintain Complete And Accurate Clinical Investigations Subject Records In Accordance With Applicable Research Regulations 3 3 Development Of New Clinical Study Protocols 3 3 1 Contractor Shall Assist Investigators With Writing And Development Of New Clinical Study Protocols Contractor Shall Provide Recommendations On Laboratory Methods Procedures And Data Interpretation Contractor Shall Facilitate Drafting Of Questionnaires Informed Consent Documents Regulatory Forms Tracking Forms Hipaa Authorization Forms And Other Forms As Required By The Study Protocol 3 3 2 Contractor Shall Provide Statistical Support For New Clinical Study Protocols To Include Performing Power Calculations And Drafting Statistical Analysis Plans 3 4 Support For Information Technology Needs Of Ihd 3 4 1 With Close Coordination And Direction Of Ihd Government Civilian Employees Contractor Shall Plan Define Develop Revise And Implement Healthcare Information Management Systems Equipment And Services With Cor Coordination Review And Approval With Approval By The Co When Necessary To Benefit The Clinical Investigations Section And Other Sections Within Ihd Contractor Shall Provide Secure Solutions To Complex Data Management And Reporting Challenges Including But Not Limited To Creating Data Forms Clinical Data Tracking Systems Development Of Online Survey Distribution Tools Etc Contractor Shall Provide Project Management Design And Programming For Existing Data Management And Analysis Tools Used By The Ihd Including But Not Limited To Vaecs Vaccine Adverse Events Case Management Module Dod Call Center Module Specimen Tracker Management Module Dh Phd Ihd Research Management Module Adhoc Clinical Data Cube Reporting Module Toolkit Inventory Management Tims Module Intramural Studies Tracking Application Recommending Coordinating And Providing It Systems Oversight To Proposed Next Generation Integrated Dha Phd Ihd Systems And Modules 4 0 Responses 4 1 Interested Parties Are Requested To Respond To This Rfi With A Capability Statement To Include Two Sections Section 1 Administrative Information Per Rfi Section 4 3 And Section 2 Requested Information Per Rfi Section 3 0 Capability Statements Should Be Tailored To The Particulars Of This Effort In Addition If Significant Subcontracting Or Teaming Is Anticipated In Order To Deliver Technical Capability Organizations Should Address The Administrative And Management Approach For Such Arrangements 4 2 Capability Statements In Microsoft Word For Office 2013 Compatible Format Are Due No Later Than July 15 2020 1 00 Pm Est Responses Shall Be Limited To 10 Pages For Section 2 And Submitted Via E Mail To Pedro Godinez At Pedro M Godinez Civ Mail Mil And Robert E Leblanc At Robert E Leblanc6 Civ Mail Mil Only Electronic Submissions Will Be Accepted Electronic Files Larger Than 10 Mb Should Be Broken Down Into Multiple Files With No One 1 File Exceeding 10 Mb Each Electronic Submission Shall Include A Rfi Number Ht0011 21 Rfi 0077 And Clinical Studies And Health Systems Applications Support In The Subject Line B If The Submission Includes More Than One 1 Electronic Email The File Number And Total Files Being Submitted E G File 1 Of 4 File 2 Of 4 Etc In The Subject Line And C A Brief Summary Of The Email s Content The Vendor s Name And Mailing Address Proprietary Information If Any Should Be Minimized And Must Be Clearly Marked To Aid The Government Please Segregate Proprietary Information Please Be Advised That All Submissions Become Government Property And Will Not Be Returned Rfi Submissions Submitted After The Due Date Ofjuly 15 2020 1 00 Pm Est Will Not Be Assessed 4 3 Section 1 Of The Capability Statement Shall Provide Administrative Information And Shall Include The Following As A Minimum 4 3 1 Name Mailing Address Overnight Delivery Address If Different From Mailing Address Phone Number Fax Number And E Mail Of Designated Point Of Contact 4 3 2 In Order For Us To Know If The Capacity At Your Company Or Organization May Be Suitable For Administering One Or More Aspects Of Providing Support For Vaccine Safety And Evaluation Studies As Well As Management Of The Related Information Technology Health Systems Applications Please Provide Answers To The Following Questions Please State The Following Company Information A Company Name B Duns C Cage D Applicable Naics Codes E All Applicable Contract Numbers I E Gwacs Gsa Oasis Gsa Professional Services Etc F Applicable Gsa Sins To Include Description Of Sin Product Service Classification Description G Business Size Status And Time Of Last Certification And H Contracting Vehicles That Would Be Available To The Government For The Procurement Of The Service I E Gsa Pss Gsa Oasis Nasa Sewp Etc This Information Is For Market Research Only And Does Not Preclude Your Company From Responding To This Notice 4 4 The Number Of Pages In Section 1 Of The Capability Statement Shall Not Be Included In The 15 Page Limitation For Section 2 Of The White Paper Section 2 Of The Capability Statement Shall Provide The Information As Requested In Section 3 Of This Rfi And Shall Be Limited To 15 Pages 5 0 Industry Discussion N A 6 0 Summary This Is A Request For Information Rfi Only To Identify Sources That Can Provide Support For Vaccine Safety And Evaluation Studies As Well As Management Of The Related Information Technology Health Systems Applications The Information Provided In The Rfi Is Subject To Change And Is Not Binding On The Government The Dha Has Not Made A Commitment To Procure Any Of The Items Discussed And Release Of This Rfi Should Not Be Construed As Such A Commitment Or As Authorization To Incur Cost For Which Reimbursement Would Be Required Or Sought All Submissions Become Government Property And Will Not Be Returned Telephone Inquiries Will Not Be Accepted Or Acknowledged And No Feedback Or Evaluations Will Be Provided To Companies Regarding Their Submissions
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