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 Workflow on the Day of the CRU Visit How to Handle Unexpected Surprises

How Do I Request Services in the CRU? Determine which CRU services you will need. Schedule a meeting with CRU management via Outlook if you aren’t sure what is available 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 Schedule a start up meeting with CRU leadership via Outlook once Cost Analysis is finalized You may request a tour of the CRU during the start up meeting to walk you through conducting a visit

What will it cost? The cost is provided when you complete your I-Cart application. Your study sponsor or funding source will be responsible for covering these costs 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” 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 Currently, CRU uses paper orders and Epic EPIC is required for medications and hospital labs All others are paper-working toward all in EPIC 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. Please review the CRU orders policy on the following slide carefully. 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…: crcscheduling@healthcare.uiowa.edu 2. Also, if you need the procedure room…: cruprocedureroom@healthcare.uiowa.edu 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: • Exam: includes an exam table, workstation, and exam materials • Consult: includes tables, chairs, and a workstation • Procedure: a larger space used for many types of procedures. • 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.

Orders and lab supplies for the visit must be delivered by noon the day before your visit 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. 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. Labels: may need to withstand -80 degree temperatures. Visit divbio.com for label options. Please to use a Sharpie Ultra-fine point Permanent Marker for labeling purposes . Bar codes: must be linear, not circular. Hospital bar codes much be aligned by notching the label and the tube. Apply labels on all tubes/aliquots in the same direction, to allow for better visualization of information and serum.

Before your visit- other information 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 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 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. 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 Room assignments can be viewed on the CRU “Dashboard” (the large monitor) in the nurses’ station If you have questions or concerns about room assignments, please speak with the charge nurse.

Participant Identification Bracelets CRU Follows Hospital Safety Policy PC-PCI 05.35 for Patient Identification Bracelet Placed on Participant at Check-in DOB and name Must be utilized to verify identification when Collecting specimens Administering medications Procedures

CRU Staff Assignments The white board hanging above the charge desk will indicate charge nurse and staffing assignments for the day as shown: If your subject is receiving an infusion, an assigned infusion nurse will care for them If your subject is having other procedures, an assigned clinic nurse or MA will complete those 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 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 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 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 Add-on requests must be approved by the charge nurse, nurse manager or assistant manager-scheduling request may be sent and will be reviewed prior to adding onto schedule 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 Link to Hospital policy on Temp Track (requested but not there yet) Link to Hospital policy on Equipment checks (requested but not there yet) 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/clinical-research-unit