Margaret Chrymko
Erie VAMC
October 2012
RESIDENCY PROJECT
VHA
Handbook
1058.05
ASHP Outcomes,
Goals, Objectives
Operations Activities that ARE NOT
Research –
(1) The activity is designed and/or
implemented for internal VA purposes
(i.e., findings are intended to be used by
and within VA); AND
(2) The activity is not designed to produce
information that expands the knowledge
base of a discipline
 Quality assessment and quality improvement activities
designed for internal VA purposes
◦ including routine data collection and analysis for
operational monitoring, evaluation, and program
improvement purposes.
Examples:
 All Employee Surveys, Voice of VA Surveys, etc.
 External Peer Review Program (EPRP);
 System-wide Ongoing Assessment and Review Strategy
(SOARS);
 VHA Quality Improvement Initiative (VQuIP).
Systems redesign activities
 Patient satisfaction surveys
 Case management and care coordination
 Policy and guideline development and
related evaluation activities
 Benchmarking activities/comparisons
 Root cause analyses
 Medication use evaluations
 Business planning/development/costmanagement/planning analyses related to
managing and operating an entity
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Consult supervisor and document ASAP
whenever there may be doubt about the
research versus non-research status
◦ If doubt, consult the relevant Program Office,
VHA Network, or VHA facility
◦ Documentation prior to initiation of the activity
is strongly encouraged when patients will not be
fully informed of the reasons for treatment
recommendations or assignments to specific
treatments or when publication of findings from
operations activities outside VA is reasonably
anticipated

Publication and Presentation Do Not Define
Research.
◦ Publication or presentation outside VA of findings
from non-research operations activities or other
non-research activities does not, in and of itself,
constitute research

Requires documentation of the non-research
status of the activities by the relevant
Program Office prior to publication
◦ Consult Handbook for specifics
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Outcome: Demonstrate project management
skills
Goal:
Conduct practice-related
investigations using effective project
management skills
(OBJ)
Initiate, design, implement, and
write up a practice-related investigation
which, at all steps in the process, reflects the
skillful application of project management
skills
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Choice of project is practice-related
Choice of project warrants investigation
Project can be completed in time available
Project proposal contains all customary
elements of a proposal
Each proposal element contains all necessary
information
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Project proposal includes identification of all
key stakeholders who must approve
Appropriate strategies designed and
implemented for gaining cooperation of all
individuals affected by conduct of the project
Project timeline milestones, if adhered to,
would result in project completion by agreedupon date
Project completed on time
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During conduct of project, project materials
well-maintained for accessibility and efficient
retrieval
Project process appropriately documented
Project materials well organized and
maintained with documentation of the
project’s ongoing implementation
Project presentation utilizes appropriate
manuscript style and meets criteria for
writing with use of that style
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Evaluate a service, part of a service
Evaluate changes in a service
Evaluate equipment, cost, time savings
Evaluate effectiveness of a change, i.e. a
reminder
Assess impact of PACT on XYZ
MUE
Other process improvement or medication
safety
Evaluate antibiotic stewardship outcomes
Ask other team members

LIMIT the size of the project
◦ Take this responsibility seriously
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Set a timeline/deadlines for sections
Educate on requirements, including VHA
Handbook 1058.05
Provide examples
Discuss expectations
Submit proposals to designated authority for
approval as non-research—DO NOT decide
yourself
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Background
Hypothesis
Objective(s)
Methodology
Analysis—can use statistics

Sound design characteristics do not,
in and of themselves, define research
◦ consider carefully whether design
characteristics are included for the
purpose of fulfilling operational needs
versus expanding the knowledge base of a
discipline
Background
 Objective(s)
 Methodology
 Analysis—can use statistics
------------------------ Results
 Discussion
 Conclusions

AVOID the temptation to generalize
VHA Handbook 1058.05
 VA Directive 6511-Presentations Displaying
Personally-Identifiable Information (Form 0897)contact Privacy Officer
 ASHP Standards
 ASHP Outcomes, Goals,
Objectives, Criteria
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Who needs to read these?
◦ Chief, supervisors, residency
program director, project advisor
AND RESIDENT
RESIDENCY PROJECT
VHA
Handbook
1058.05
ASHP Outcomes,
Goals, Objectives


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VHA Handbook 1058.05
VA Directive 6511
ASHP PGY1 Pharmacy Residency Outcomes,
Goals, Objectives, Criteria
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Residency Projects without an IRB