ࡱ> rq|E bjbjAA 4++(@~~8vv3x3<*4 uuuuuuu$ox!{v9J4.v3J4J4vGv888J4R u8J4u88jkPpPu[O4vl2u]v0vmJ{5{dPpPpp{pJ4J48J4J4J4J4J4vv8J4J4J4vJ4J4J4J4{J4J4J4J4J4J4J4J4J4~ : For questions and assistance in completing the checklist and approval process please contact ____________________. Checklist for Students Conducting Academic Projects Within VAPHSProject TitleNamePositionUnit/Service LineNurse Manager / Immediate SupervisorUniversityUniversity AdvisorVAPHS Preceptor or Committee Member I am conducting an academic project (e.g. Capstone project, etc) in partial fulfillment of the following degree:  FORMCHECKBOX  MSN  FORMCHECKBOX  DNP  FORMCHECKBOX  Other. Please specify:  FORMTEXT       Anticipated graduation date:  FORMTEXT       When do you plan to conduct your project?  FORMTEXT       Key Stakeholders: Please provide units/care areas where you plan to conduct the project. Unit/Care Area Nurse ManagerService Line Associate Chief Nurse Service Line VP1.2.3. 4.5. Project Proposal Information Instructions: All students conducting an academic project at VAPHS will be required to complete a Project Proposal (see Attachment A). If your project involves data collection & analysis, include a detailed description of your data collection and security plan in your Project Proposal. Submit your Project Proposal to the ACN/Research and key stakeholders listed in the table on the first page. Contact other stakeholders and include additional information as specified in the instructions below.NOYESProject PlanInstructions FORMCHECKBOX  FORMCHECKBOX Does the University have an Affiliation Agreement with VAPHS? You may not conduct a school related project at VAPHS without an Academic Affiliation Agreement.Contact the Medical Center Education Department for verification.  FORMCHECKBOX  FORMCHECKBOX Will you be utilizing the VAPHS library services for this project?If yes, contact Chief of Library Services for more information. FORMCHECKBOX   FORMCHECKBOX Does your project involve education for staff? If yes, does your project involve a pre-test/post-test component?  FORMCHECKBOX  Yes  FORMCHECKBOX  NoIf yes, include a detailed Staff Teaching Plan (Attachment B) and the pre/post test (if applicable) with your project proposal.  FORMCHECKBOX  FORMCHECKBOX Does your project involve education for patients? If yes, contact the Veteran Health Education Coordinator (VHEC) to discuss the approval process for implementing patient education. You will need to meet VAPHS patient education criteria and standards. Include a detailed Patient Teaching Plan (Attachment C) with your proposal. FORMCHECKBOX  FORMCHECKBOX Does your project involve a nursing practice or process change?If yes, attach relevant policies, procedures, or SOCs to your project proposal.  FORMCHECKBOX  FORMCHECKBOX Does your project involve an administrative practice or process change? If yes, attach the relevant policies to your proposal. FORMCHECKBOX  FORMCHECKBOX Does your project involve a secondary analysis of current practice or processes?If yes, provide a complete description of the secondary analysis plan in your project proposal.  FORMCHECKBOX  FORMCHECKBOX Does your project involve conducting a staff survey? If yes, provide a copy of the survey and a description of your plan to conduct the survey. NOYESProject PlanInstructions FORMCHECKBOX  FORMCHECKBOX Does your project require AFGE notification? Contact your immediate supervisor to determine if AFGE notification is necessary. If yes, provide verification of notification with your proposal.  FORMCHECKBOX  FORMCHECKBOX Does your project involve the presentation or collection of any data (patient, staff or organization level data)? If yes, a formal VAPHS IRB QA/QI determination is required prior to starting the project. Refer to the QA/QI Determination Submission Instructions (Attachment D). The QA/QI determination will establish if your project is QA/QI or research. The IRB Chair or designee will notify you of your project status determination. Please allow 4-6 weeks for a QA/QI determination. See the QA/QI Determination Flowchart below. If your project is determined to be QA/QI, you will need approval to conduct the project from key VAPHS stakeholders, including the unit/care area Nurse Manager(s), Associate Chief Nurse(s), and Service Line VP(s) listed in the table on the first page. Other approvals may be required based on the scope of the project. Submit a copy of the Academic Project Determined to be QA/QI Project Agreement Statement (Attachment E) to the ACN/R prior to starting the project. Once the ACN/R receives this agreement, you may start the project. If the project is determined to be research, IRB and R&D approval are required before you can conduct the project. Do not start the research study until you receive a letter from the ACOS R&D indicating that you have permission to conduct the study. This letter is required before you can conduct an academic project within VAPHS that is determined to be research.  YesNoDissemination PlanInstructions FORMCHECKBOX  FORMCHECKBOX Permission to disseminate project results outside VAPHS has been obtained from 1) your immediate supervisor; 2) Service Line ACN; 3) Service Line VP; and 4) Directors Office. NOTE: Permission to disseminate project results outside VAPHS is required through the Directors Office as outlined in VAPHS Handbook 1058.05 and VAPHS Memorandum LD-077 VHA OPERATIONS ACTIVITIES AND RESEARCH. This includes dissemination in the form of oral presentations and/or manuscripts submitted to your academic institution. Please allow 3-4 weeks to obtain the necessary signatures required for dissemination. Attachment A: Project Proposal Project TITLE: Background and Significance: Project Goal / Key Practice Question / PICO-T Question: Description of the Project or Practice Change: Description and Timeline of Implementation Plan: Evaluation of Project or Practice Change (Process and Outcomes): Data Collection and Security Procedures (How are you managing and protecting the data): Practice Implications / Sustaining Measures: References: Attachments: Attachment B: Staff Teaching Plan Presentation Title: Intended Audience: Timeframe: Learners Objectives: Content Outline: Teaching Methods: Evaluation Plan: Attachment C: Patient Teaching Plan Presentation Title: Intended Audience: Who will conduct the teaching? Learners Objectives: Content Outline: Teaching Methods: Evaluation Plan: Will the teaching be recorded in the patients record? If so, who is responsible for documentation? Attachment D: QA/QI Determination Submission Instructions All QA/QI determination submission will be electronic (through email). Contact Dr. Melissa Taylor for information on who to include on the email submission. Include in the email subject line: Academic Capstone QA/QI Determination Request Include the following language in the body of you email (cut and paste)  I am submitting the following project (project title) for QA/QI determination. This project is being completed in partial fulfillment of a (specify degree) at (specify university). I have informed my Nurse Manager (or immediate supervisor), Service Line Associate Chief Nurse, Service Line VP, and the Associate Chief Nurse for Research (ACN-R) of my proposed plan to conduct this project. They are included on this email. I have read the QA/QI policy and understand that my project may meet the definition of research as specified in VHA Handbook 1058.05. If my project is determined to be research, I will submit my project for review to the appropriate VAPHS review committees. I will not initiate any work on the project until I have received notification from the Associate Chief of Staff for Research and Development (ACOS/R&D) that my project has received all required approvals. Project Implementation: Please check one: _____The project has not been started. I will not implement my proposed project or collect any data related to this project until I receive all of the required VAPHS approvals. I will contact the IRB Chair and the ACN-R immediately in the event that project activities occur prior to receiving all required VAPHS approvals. _____The project has been started. I agree to stop project implementation until I receive all of the required VAPHS approvals. Please provide complete detail as to what has been done up to this date. The following attachments are included: Project Proposal VAPHS QA/QI Worksheet Thank you for your consideration. Include the following documents in your email: Project Proposal QA/QI Checklist Evidence of stakeholder support Please contact ACN/Research for help in securing stakeholder support. Allow for 4-6 weeks turn-around time between submission and determination. QA/QI VAPHS Documents:  EMBED Word.Document.8 \s   EMBED Word.Document.8 \s  QA/QI Determination for Academic Projects Flowchart                       Attachment E: Academic Project Determined to be QA/QI Project Agreement Statement Date: ____________________________ To the Associate Chief Nurse for Research, I have completed VAPHS annual security training requirements on __________________ (date) and will comply with all VHA information security standards and requirements. My project was determined to be QA/QI on __________________________ (date). A copy of the QA/QI Determination is attached. I have read and will comply with VAPHS guidance and policies on conducting QA/QI projects at VAPHS. I will not start my project until I have received final concurrence from the key stakeholders as listed on the Academic Project Checklist. I have read and will comply with the guidance on disseminating QA/QI projects as outlined in Handbook 1058.05 and Memorandum LD-077 VHA OPERATIONS ACTIVITIES AND RESEARCH. I will obtain all required approvals prior to disseminating the results of my project. Name (printed): _______________________________________________________________________ Signature: _____________________________________________________ Date _______________ Project Title: __________________________________________________________________________      Sample Guidance for Completing Academic Projects at VAPHS Version 1.2 October 2013  PAGE \* MERGEFORMAT 10 | Page Project Proposal 1. Prior to Starting Project Notify ACN/Research and key stakeholders of intent to conduct academic project. Unsure or if collecting data IRB Determination QA/QI? Investigator Determination NO YES 2. Obtain Approval to Conduct (Project Agreement Statement) Supervisor Service Line Administration RESEARCH ISO/PO as needed 3. 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K bV 5V5Xn(s=&k/>5L0) > ! $g%Z@%zY'dd'SR(~() */*,+M++-".O1. 0m1 1UX23D495`5 61w6`7wa7f89r;'<==-Y=(>4S?b?lACADtXFaRH#KS/KHORVRSlS\TUxU-WVWM[%\y/\'_^A_$`sa c5fcffjMkOmLo`q,qr;sgs9v?v6wXwxxoxwxs@z ~8y3y*| 2/tc(.e6p2<EL`0[Vd\rc?7Qy HqX`SxOQF-CeUGiq?qMsezB a] cy@|MxoVPE$Kv#E3a:,JaIer{N_] wL`cBf l3%DDoIsDz"xg%3%Ld{|K 2? q{ @#X@Unknown G* Times New Roman5Symbol3. * Arial5. *aTahomaMNLucida HandwritingY TKWQHH+Arial-BlackArial?= * Courier New;WingdingsA BCambria Math"1hFF/F  x24d  3qHX ?:!xx DEPARTMENT: vhacocodym vhapthtaylomX                !#$%&')*+,-./012356789:;<=>?@ABDEFGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnoqrstuvy  F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89q@   F'Microsoft Office Word 97-2003 Document MSWordDocWord.Document.89q@ #bjbjVV ;2<< r r ///8g$,/WRX{{{WWWWWWW9Z\lW^ww^^W  hW^^^^8W^^W^^PS b5/ R,vWW0WFRG]G]XSSG]Td{"^{{{WW"<{{{W^^^^G]{{{{{{{{{r {: POLICY NUMBER: 013 APPROVAL DATE: 12/07/2010 EFFECTIVE DATE: 12/08/2010 TITLE: Quality Assurance/Quality Improvement Projects 1.0 PURPOSE This policy describes the procedures and responsibilities of VAPHS employees and the VAPHS Institutional Review Board regarding the conduct and review of Quality Assurance/Quality Improvement Projects at VAPHS. 2.0 Revision History DateRevision #ChangeReference Section(s)November 23, 20101.1Reformatting of original policy 3.0 SCOPE This policy applies to all VAPHS employees involved in the conduct of Quality Assurance/Quality Improvement projects at VAPHS. 4.0 POLICY As a part of hospital operations, service lines are expected to complete quality assurance projects. These quality assurance projects frequently use research methodology, blurring the line between research and quality assurance. The VAPHS Research Office acknowledges that requiring submission of all quality assurance projects to the IRB would unnecessarily burden both non-researchers and the IRB. However, when quality assurance projects meet the definition of human subjects research, they must be submitted to the IRB for review. Staff members are urged to compare their written project plan to the QA/QI Worksheet to determine if they should submit their project to the IRB. If any question exists as to the status of the project, it should be submitted to the IRB for a formal determination. The IRB may deem the effort as QA/QI or as Human Subjects Research. The Research Office also acknowledges that some quality assurance projects evolve into research studies based on the data generated. Staff members should be aware of the criteria for quality assurance determinations, and immediately report to the IRB when they feel that the project will cross the line into research or will produce publishable results. In some cases this may occur during the data collection, but it may also occur after the data are analyzed. Note that in such cases a research plan must be submitted to the IRB prior to any peer review. In this plan, investigators must clearly identify the quality assurance portion of the investigation, describe any additional analyses of the existing data or additional data collection that may be planned, and provide adequate justification for why the project was not submitted to the IRB prior to data collection. Compliance with this policy will be assessed on an annual basis by various means including but not limited to direct audits as well as audits of peer reviewed publications. Staff members who conduct quality assurance projects are strongly encouraged to file their completed QA/QI worksheet with their project plan to facilitate this assessment. Staff members should also keep in mind that use of protected health information for health care operations such as QA/QI projects do not require individual patient authorization, however any use of such protected health information for research purposes requires either written patient authorization approved by the IRB or a documentation of waiver of such authorization by the IRB. Failure to obtain such approvals for activities that could be deemed human subjects research could result in civil and criminal penalties in accordance with the Health Insurance Portability and Accountability Act. //Signed// Gretchen L. Haas, PhD Research and Development Committee Chair //Signed// Ali F. Sonel, MD, FACC, FACP Associate Chief of Staff for Research and Development     PAGE  VAPHS Research and Development VAPHS R&D Policy#008_QA/QI Page  PAGE 2 of  NUMPAGES 2 VA Pittsburgh Healthcare System Research and Development VAPHS R&D Policy #013_QA/QI Page  PAGE 1 of  NUMPAGES 1  VA regulations at 38 CFR 16.102(d) define research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. VA regulations at 38 CFR 16.102(f) define human subject as a living individual about whom an investigator (whether professional or student) conducting research obtains either (1) data through intervention or interaction with the individual; the interaction includes communication or interpersonal contact between the researchers and the subject; or (2) identifiable private information. Private information includes information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., a medical record), and information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Identifiable means that the identity of the individual is or may readily be ascertained by the investigator or associated with the information. FDA regulations at 21 CFR 56.102(c), define research as any experiment that involves a test article and one or more human subjects. The FDA regulation further states that The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part. 21 CFR 56.102(e) defines human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. FDA regulations at 21 CFR 812.3(p) define a human subject as a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease. 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Arial Narrow5. *aTahoma?= * Courier New;WingdingsA BCambria Math"hFFb, , !24d +3HX?;*!xx-CHECKLIST USED BY IRB FOR REVIEW OF PROPOSALSIRB vhapthtaylom   ObjInfoWordDocument.:SummaryInformation(DocumentSummaryInformation8"      !#$%&'()+,-./01237689:C;<=>?@ABDGHIJKLMNOPQRSTUVWXYZ[\]^_`abcdefghijklmnopqrstuvwxyz{|}~  5bjbjVV .:<< 58S4d!lWWWW2lM!O!O!O!O!O!O!#P&O!-22O!WW|!&&&WWM!&M!&&VQ @ WSj5z 9!!0! &z & & &O!O!!& : QA/QI Project Title:  FORMTEXT       Responsible Staff Member:  FORMTEXT       Department:  FORMTEXT       Reason For QA/QI Effort:  FORMCHECKBOX VHA/VISN Directive  FORMCHECKBOX Local Directive  FORMCHECKBOX  Other ____________________ QUALITY ASSURANCE/QUALITY IMPROVEMENT (QA/QI WORKSHEET) CONDITIONS FOR DETERMINATION OF QA/QI STATUSYesNoThe primary intent of the project is not peer reviewed publication and if publication of the results was prohibited, the project would still have merit as a QA/QI effort FORMCHECKBOX  FORMCHECKBOX There is a documented commitment, in advance of data collection, to a corrective plan given any of a number of study outcomes. FORMCHECKBOX  FORMCHECKBOX The responsible staff member has both clinical supervisory responsibility and the authority to impose a corrective plan based on the outcomes of the project. FORMCHECKBOX  FORMCHECKBOX The project does not involve prospective assignment of patients to different procedures or therapies based on a predetermined plan such as randomization. FORMCHECKBOX  FORMCHECKBOX The project does not involve a control group in whom therapeutic or study intervention is intentionally withheld to allow an assessment of its efficacy. FORMCHECKBOX  FORMCHECKBOX The project does not involve the prospective evaluation of a drug, procedure or device that is not currently approved by the FDA for general use (including off-label indications). FORMCHECKBOX  FORMCHECKBOX Human participants will not be exposed to additional physical, psychological, social or economical risks or burdens (beyond patient satisfaction surveys) in order to make the results of the project generalizable.  FORMCHECKBOX  FORMCHECKBOX Adequate protections are in place to maintain confidentiality of the data to be collected and there is a plan for who can access any data containing participant identifiers. FORMCHECKBOX  FORMCHECKBOX The project is likely to improve patient care activities and/or outcomes at the VA Pittsburgh Healthcare System alone or as part of the VISN-4 or VHA. FORMCHECKBOX  FORMCHECKBOX  In order for the study to be classified as a QA/QI effort, the answers to all of the above questions must be Yes. If one or more answer is No then the project requires full review and approval by the VAPHCS IRB. Note: If the investigator intends to publish any literature referencing this project, submission of a protocol to the IRB for additional review is required PRIOR to analysis for research purposes and submission of the manuscript. 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