Transcript New Coordinator CRU Orientationx

CRU
Orientation
Academy for
Research
Professionals
Fall 2016
Clinical Research Unit
Objectives
 How
to Request Services and Start Ups
 Preparing
for a CRU Visit
 Understanding
the CRU Visit
 How
Workflow on the Day of
to Handle Unexpected Surprises
How Do I Request Services in the
CRU?
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Determine which CRU services you will need.
Schedule a meeting with CRU management via
Outlook if you aren’t sure what is available
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Fill out a Cost Analysis CRU application on I-Cart:
https://i-cart.icts.uiowa.edu/service_requests/104420/catalog?signed_up_but_not_approved=false
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Schedule a start up meeting with CRU leadership
via Outlook once Cost Analysis is finalized
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You may request a tour of the CRU during the start
up meeting to walk you through conducting a visit
What will it cost?
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The cost is provided when you complete your ICart application. Your study sponsor or funding
source will be responsible for covering these costs
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If you just want an estimate of CRU services use
the option at the end of the I-Cart application to
“get estimate” instead of “submit”
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Request to meet with CRU management to review
estimates
CRU Orders

Any study activity to be carried out by CRU staff
will require a signed doctor’s order
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Currently, CRU uses paper orders and Epic
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EPIC is required for medications and hospital labs
All others are paper-working toward all in EPIC
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You may write your orders with your PI or CRU will
provide this service to your team. There is an
hourly CRU charge for this service.
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Please review the CRU orders policy on the
following slide carefully.
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CRU will print orders for your team on A1a form
CRU Orders Policy
Changes to Orders
 If
any part of orders are to be eliminated,
research team MUST cross out, time, date,
and initial
 Study
team is responsible for keeping
orders updated. If CRU writes orders,
contact leadership for revisions
Preparing for your
participant visit…
Schedule Using Outlook
Calendar

How to schedule participants on the CRU

How to schedule a visit to the CRU: using Outlook Calendar. (Please try to have scheduling requests for the next day done
prior to 1200 the day before the visit. Requests received after this time will need to be approved by CRU management. If a
late scheduling request for the next day is unavoidable, please call 356-1061 and inform RN staff to make an appointment.
The RN staff may seek the guidance of the manager for questions concerning late appointments)
1.
To…: [email protected]
2.
Also, if you need the procedure room…: [email protected]
3.
Subject window: PI name, and CRU protocol number (Smith 0123)
4.
Location window: this is where you ask for the type of room needed:
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Exam: includes an exam table, workstation, and exam materials
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Consult: includes tables, chairs, and a workstation
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Procedure: a larger space used for many types of procedures.
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Infusion bay: includes carrels with mainly recliners, but 2 with beds. Carrels include call systems, TVs, and
telephones. Suitable for multi-hour stays, and close observation.
•
Overnight beds: by request, and only for true overnight stays.
5.
Start time window: fill these windows with the date, and time, of the visit request
6.
End time window: estimate the time the study will conclude, and the participant will leave the requested room.
7.
Text window:
•
Name and MRN of participant. If subject has no MRN, need to supply FULL name, FULL address and Date of Birth.
Phone number is desirable.
•
Specific visit (if applicable). This text should reflect the name of the visit assigned to the order being used for the
visit. The name of the order should be traceable to the protocol schedule of events.
•
If your visit requires multiple types of rooms, give a very clear sequence of the types of rooms needed, in the
order needed, and the expected duration of time in each room.
•
Any special equipment or any unusual aspects to the visit (known resistant organisms, mobility issues,
communication issues).
•
Complicating/conflicting situations (for example, subject needs to ‘break away” from CRU visit to do DEXA/MRI
etc and will then come back to CRU to finish study).
•
Request an RN if one is needed for the study. If an RN is not requested, the study will be assigned to non-licensed
staff.
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Orders and lab supplies for the visit must be
by noon the day
before your visit
delivered
Log orders in this book under the date
your visit will take place. Make sure to
find the correct day and month. There is a
separate page for each calendar day.
Place all items in this tub.
Labeling
Tubes and Shipping Kits

Central lab Kits and Shipper Exteriors: participant ID, date of visit, PI & protocol
number. A sticky note is preferred. These materials must be traceable to an order.

Requisition: Complete as much required information as possible visit prior to the visit
Highlight information needing to be filled out by CRU staff.
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Tubes and aliquots: label accurately with the required information. Leave clear
portions uncovered. This aids in aliquotting properly. TIME OF DRAW will be filled in by
CRU staff.
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Labels: may need to withstand -80 degree temperatures. Visit divbio.com for label
options.
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Please to use a Sharpie Ultra-fine point Permanent Marker for labeling purposes .
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Bar codes: must be linear, not circular. Hospital bar codes much be aligned by
notching the label and the tube.
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Apply labels on all tubes/aliquots in the same direction, to allow for better
visualization of information and serum.
Before your visit- other
information
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CRU MUST confirm consent prior to performing
any study activities on a patient.
 If consent was obtained before the study visit,
make sure record of consent is scanned into
EPIC
 If participant needs to be consented at visit
indicate consent is needed on the orders
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Indicate who the first contact from the study
team for the patient will be on the day of the
visit by circling that person’s name on the order
sheet
The day of your visit
Arrival in CRU, conducting your visit
Arrival in CRU
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CRU charge nurse will page the contact person circled on your
orders when your participant is checked-in, no need to return the
call. If no one is circled, CRU will assume that your team will be
present at the time the subject checks into CRU.
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Our charge nurse assists with care of the participants and may
need to step away from the desk. It is best practice to watch on
EPIC for your patient to be checked in for a visit, or to be present in
CRU when you know you have a patient checking in
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Room assignments can be viewed on the CRU “Dashboard” (the
large monitor) in the nurses’ station
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If you have questions or concerns about room assignments, please
speak with the charge nurse.
Participant Identification
Bracelets
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CRU Follows Hospital Safety Policy
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Bracelet Placed on Participant at Check-in
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PC-PCI 05.35 for Patient Identification
DOB and name
Must be utilized to verify identification when
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Collecting specimens
Administering medications
Procedures
CRU Staff Assignments
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The white board hanging
above the charge desk will
indicate charge nurse and
staffing assignments for the
day as shown:
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If your subject is receiving an
infusion, an assigned infusion
nurse will care for them
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If your subject is having other
procedures, an assigned clinic
nurse or MA will complete those
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Reminder for infusion bay: Please
respect privacy of participants.
They are undergoing procedures
and may have curtains drawn or
sterile procedures occurring –
please check with the nursing
staff before entering infusion bays
Conducting your visit
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Vital Signs room: You are welcome to wait outside of
the room. There are two stations and at times can
be crowded. Also, talking may produce inaccurate
participant vital sign measurements
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Minimizing Interruptions: Please try to minimize
interruptions of CRU staff as much as possible during
procedures, especially in the lab and infusion bays.
Interruptions can slow our staff down and increase
the chance of error or deviation
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Charge Nurse: If you have a question or concern,
please speak with the charge nurse
Conducting your visit
 If
you have a participant ready to be
seen but no CRU staff are available, place
papers here:
 Turn
on flashing light
 A CRU staff member will see your subject
as soon as possible
Unexpected situations
No-shows, cancellations, add-ons, changes to
written orders
Cancellations and No-Shows
 If
a subject cancels or no-shows for an
appointment, retrieve all visit-specific
materials
 If
a subject is immediately rescheduled,
and identical materials are to be used,
communicate to CRU staff the change,
and re-date all materials
Add-ons

Add-on: subjects who are scheduled after noon
the day before their requested visit
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Add-on requests must be approved by the charge
nurse, nurse manager or assistant managerscheduling request may be sent and will be
reviewed prior to adding onto schedule
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Staffing Available?
Room Available?
Orders Signed?
Supplies Available?
Standard of Care Orders
 Standard
of care labs/tests on CRU orders
must be approved/communicated with
CRU Nurse Manager, ANM, or charge
nurse
 Approved
Standard of Care Orders (ie:
labs) must be entered into EPIC per study
team member by noon the day before
the visit
CRU Policies
 Please
review official CRU policies, letters
for sponsors, etc., on The Point:
 https://thepoint.healthcare.uiowa.edu
 Select “Clinical” -> “Policies and
Procedures”->“Research”->“CRU”
Pertinent Policies

Staff Qualifications and Training –last updated
10-24-16
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Link to Hospital policy on Temp Track
(requested but not there yet)
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Link to Hospital policy on Equipment checks
(requested but not there yet)
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How to schedule participants in the CRU(to
be added)
CRU Website
 For
more information on the CRU, please
visit our website:
https://www.icts.uiowa.edu/research/clini
cal-research-unit