Transcript Doctor's Orders - Massachusetts General Hospital

Doctor’s Orders
Why Utilize Accurate
Doctor’s Orders?
Doctors Orders are:








Legal documents for completion of study visits by GCRC
staff.
The responsibility of the investigator.
Signed (not stamped) by the investigator.
Written in a specified format.
Implementation guidelines for GCRC staff for study
completion.
A reflection of the protocol design and study question(s).
Ready for implementation upon approval by the GCRC.
A guide to the development of templates used for scheduling
study visits.
When to Submit Doctor’s
Orders
Submit a complete set of the most current (Microsoft
Word version) of Doctor’s Orders with the Protocol
Application.
Refer to Doctor’s Order sheet template for format
(found at MyNetworkPlaces\GCRCM_DO).
Electronically submit to the GCRC Administrative
Coordinator at [email protected].
Draft (pending) orders will be posted in the GCRC
online doctors orders found on Partners desktop at:
MyNetwork places\GCRCM_DO
Review of Doctor’s Orders
Draft (pending) Doctor’s Orders are reviewed and
approved by the protocol nurse, protocol
bionutritionist and administration.
Points considered during the review process:
 Consistency with the study proposal and
procedures.
 Clarity of study procedures for implementation by
GCRC staff.
Once reviewed & approved, the Doctor’s Orders are
converted to PDF Files, marked with the Approval
Date and stamped with the GCRC watermark and
placed in the SPID’s approved folder.
Approved Doctor’s Orders
The “GCRC Approval
Date” must match the
date the orders were
last approved. This
ensures we are using
the most recent orders
revision.
All orders must have
the GCRC watermark.
This ensures they have
been printed from the
approved folder on the
Doctor’s Orders drive.
Access to Approved Doctors
Orders
To obtain access to the GCRC online Doctors
Orders, please contact the GCRC Administrative
Coordinator [email protected].
The GCRC online doctors orders are found (on
Partners desktop) at:
MyNetwork places\GCRCM_DO
For study visits, only approved, water-marked and
dated Doctor’s Orders will be accepted.
When are Revised Doctor’s
Orders Needed
Changes in the conduct of a study visit must be
reflected in revised Doctor’s Orders.
Revisions may include changes in study staff,
addition/deletion of a test, increase or decrease of
medication dose, etc. Changes in Doctor’s Orders
often require an IRB amendment and approval.
In the email to the GCRC Administrative Coordinator
[email protected], describe the change(s),
including the IRB amendment number, when
applicable. This will speed review and approval.
Revised Doctor’s Orders
When changes are needed in approved Doctor’s
Orders, submit (Microsoft Word version) revisions as
a complete set of revised (pending) Doctor’s Orders)
to the GCRC Administrative Coordinator
[email protected].
These revised Doctor’s Orders will be placed in the
pending folder and cannot be used for study visits
until approved.
Prior to submitting revised Doctor’s Orders, review
revisions with the Principal Investigator, protocol
nurse, protocol bionutritionist and administrator.
Revised Doctor’s Orders are reviewed and approved
by GCRC staff within 3 days of receipt.
The orders are then placed in the Approved Folder at
(MyNetwork Places\GCRCM_DO) and may now be
used for subject visits.
Scheduling Templates and
Doctor’s Orders
Study visit templates reflect approved Doctor’s
Orders.
These study visit templates are developed by the
scheduler in consultation with the protocol nurse,
protocol bionutritionist and study team.
Keeping the number of study visit templates to a
minimum will facilitate scheduling.
Scheduled Subject and
Doctor Orders
Complete the Doctor’s Orders as soon as the visit is scheduled
and confirmed with the patient.

Make sure randomization/enrollment numbers are correct so that all
samples will be accurately labeled at the time of the visit.
Bring completed Doctor’s Orders to the GCRC reception desk.



Log all orders in the Red Book.
The GCRC prepares the trays/labels so incorrect/illegible info on
the Doctor’s Orders may result in lab errors!
When bringing up Doctor’s Orders for a last minute visit, always
alert the front desk, in addition to logging them in the Red Book. If
it is last minute, the GCRC needs the orders right away so they can
prepare the tray.
Remember to never cross out any part of the doctor’s orders. If
a change is needed, the study investigator should write a note
on a separate progress note and attach it to the doctor’s orders.
Dropping Off Orders
Once a visit is scheduled, please drop off the
most current signed, dated and timed
approved doctor’s orders to the GCRC front
desk.
Doctor’s Orders should be placed in the black
“Orders” bin on the desk.
Please use the red book to sign in the
date/time orders were dropped off along with
your name.
How do I use the red book?
When dropping off orders, fill out the columns
as shown below.
Leave the last three columns blank for OA use.
GCRC Doctor's Orders Received
Date Received Patient Name
10/31/2007 Doe, John
10/31/2007 Claus, Santa
10/31/2007 White, Snow
Study # Visit Name Dropped off By
901 baseline
997 6-month
873 18 month
Study Coordinator 1
Study Coordinator 2
Study Coordinator 3
Recv'd By Time Filed Location
When is the deadline for
dropping off orders?
Signed Doctor’s Orders must be received NO
LATER than the morning of two business
days before the visit.
Two days allows sufficient time for study visit
preparation.



Trays and Labels
Food
Equipment
Remember, earlier is better!
Order Deadline Examples
Patient Visit
Orders Due
4:00pm Wednesday
Monday morning
11:00am Sunday
Thursday morning
8:00am, Tuesday after Thursday morning
Columbus Day
What about add-on visits?
If you add a visit less than two days
before the visit, you must drop off the
Doctor’s Orders as soon as the visit is
scheduled.
What is Required for the OA
to Accept the Orders?
The “GCRC Approval
Date” must match the
date the Doctor’s
Orders were last
approved. This ensures
we are using the most
recent revision.
All Doctor’s Orders
must have the GCRC
watermark. This
ensures they are
unaltered.
Why are orders rejected?
When there is no watermark
When the date on the orders is before
the most recent revision
When the orders are unsigned
When the pre-printed Doctors Orders
have been altered. Changes must be
made on a separate Doctor’s Order
sheet.
Signed Orders
All orders must be signed by a study
MD, NP or PA.
It is against federal law for us to use
orders that have not been signed by an
MD,NP or PA, or that have been altered
by somebody other than an MD, NP or
PA on the study team.
What happens if orders I
dropped off are rejected?
The Operations Associate at the GCRC
front desk will notify you immediately,
and tell you what to do in order for the
orders to be accepted.
What if the Doctor’s Orders
need to be altered?
Alterations to the orders, even those made by
a study MD, NP, or PA must be first approved
by the protocol RN or RD, depending upon
which section is altered.
The RN or RD will make sure the alterations
fall within the HRC-approved protocol.
Altered Doctor’s Orders will not be accepted
unless they are approved.
Identifying Orders
YES
Claus, Santa 000-00-00
NO
Neatly write the
subject’s name and
medical record
number on the
orders.
Make sure to leave
space for the blue
card stamp!
Trays and Labels
Introduction
Study staff provide Doctor’s Orders and
materials needed for the visit.
Materials for your subject’s visit are set
up in advance by GCRC staff, in
accordance with the Doctor’s Orders.
Background
Trays and Labels Technicians are
GCRC support staff who set up the visit
materials.
Trays and Labels Technicians are not
the same as Laboratory Technicians.
Techs are non-clinical staff.
For the benefit of all, Doctor’s Orders
must be clear and specific.
Responsibilities
The responsibilities of Trays and Labels
Technicians include:
Printing out labels and lab slips for each
visit
 Accurately labeling specimen tubes
 Setting up trays of specimen tubes per the
Doctors Orders

Effective Doctor’s Orders
for Trays and Labels
Doctors Orders must be written with
clarity and specificity to ensure that
specimens are processed according to
study requirements.
For example, for a 24-hour urine
collection, specify whether this should
be collected in a plain, acid, or split
container.
Effective Doctor’s Orders
for Trays and Labels
Keep orders separate. For example,
separate 24hr urine orders from others.


INCORRECT: “Discharge patient with teaching
sheet, plain 24hr urine collection, and 2 weeks of
medication.”
CORRECT: “



Discharge patient home with plain 24hr urine collection.
Discharge patient with teaching sheet
Discharge with 2 weeks of study medication.
Effective Doctor’s Orders
for Trays and Labels
Orders should include a list of every
tube needed, with color and size.
Make sure to specify how each tube
should be labeled.
Writing Clear Orders
Some color tubes come in more than
one size. Specify which size you will
need. Double-check that this is the
correct size for the tests that need to be
done, and that this is a size carried by
the GCRC.
Tubes
The following slide lists the tubes that
are carried by the GCRC, along with
their types and the tests they are
commonly used for. All other tubes
must be supplied by the coordinator.
GCRC Tube List
Tube
Type(s)
Common Test(s)
Green
3mL, 10mL
STAT electrolytes,
chemistries
Green/Gray
Red
4mL
electrolytes, chemistries
5mL, 10mL
chemistries, blood bank,
serology
Lavender
3mL, 6mL, 10mL
hematology, 3mL: CBC,
HbA1c
Light Blue
Gray
Yellow
Black
Falcon
4mL
coagulation
4mL
glucose
8.5mL
blood bank
10mL
urine
Cloudy, Clear
for investigator
Study Supplies
All study-provided supplies must be delivered
to the Trays and Labels Techs. If a tech is not
available, supplies can be left with Front Desk
personnel at the same time as the Doctor’s
Orders. Supplies must be delivered during
business hours. Examples of supplies
include aliquot tubes, other special tubes,
kits, and special lab requisitions.
Study Supplies (continued)
Study staff should restock supplies before
they run out. Study-specific supplies not
needed for Trays and Labels must be brought
up 24hrs in advance of the visit may result in
cancellation of the visit.
Clean supplies are to be kept in designated
bins in the Clean Utility Room. Cardboard,
coolers, and study-specific bulk supplies can
not be stored on the GCRC. Feel free to
contact a tech if you are unsure if you have
sufficient supplies for your study.
Subject Information
Double-check that the following information is
correct on the Doctors Orders:




Provider number
Medical Record Number
Spelling of the subject’s name
Randomization Number
Please stamp with an addressograph, type,
or print neatly.
Subject Information
The information on the Doctors Orders
will go on tubes, processing slips, lab
requisitions and more.
If this information is incorrect, test
results may not be recorded for the
correct subject.
Subject Information
Some Doctor’s Orders have check
boxes that change the setup depending
upon various factors (i.e., weight of the
subject). Please check off the correct
box and complete all information before
you submit the Doctors Orders.
Setting up a Tray
Doctors Orders must be brought to the
floor the morning of two business days
before the visit. (see “Facilitating the
Visit”)
Doctors Orders for add-on visits must
be brought to the floor as soon as
possible.
Supplies and Late Orders
If Doctors Orders are not brought to the
unit in a timely manner, the supplies
may not be ready in time for the visit.
For longer visits, the visit may need to
be delayed or rescheduled.
For shorter visits, the coordinator may
be required to assist setting up the tray.
Go Back to GCRC Orientation
Please click here to Doctors
Orders SOP