SAMPLE TEMPLATE FOR OP BLOOD DRAW VISIT WITH KIT
Notes: Green used for Notes/Reminders that will help you fully complete the orders for your
protocol.
Blue: Options you can choose from for your protocol’s orders.
NOTE: Specify what tasks CRU nursing vs study staff are responsible for doing.
Protocol #811: PEG-Intron Plus Ribavarin for the Treatment of Subjects with Chronic
Hepatitis C
STU#: _____
PI: Dr. Steven Flamm
phone: 5-5555 pager: 5-0000
Study Coordinator: Kim Sipitch phone: 5-2222
pager: 5-3872
NOTE: List PI, coordinator(s) and others who should be contacted during study visits along with phone/pager
numbers.
DAY 1 / TREATMENT WEEK 18 Date: ______________
Pt. Study #: _____________
NOTE: need a set of orders for each day the subject is at CRU
NOTE: If multiple visits will have duplicate orders, you can combine orders and list the visits. Leave a line for the
nurse to fill in the actual date.
1.
2.
Admit subject to CRU Outpatient.
Consent will have been previously obtained by study team and supplied to CRU staff./Consent obtained
upon subject arrival/ Page ___ at ___ to have subject consented.
NOTE: The CRU must have a signed subject consent before any treatment can begin.
3. Page Dr.Flamm pager (5-000) to: perform H/P, AE assessment.
NOTE: list tasks that MD completes (e.g. sign orders, h/p, AE assessment, GI/liver exam, pain score, ECOGPS,
etc.)
4. CRU Staff to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral
temperature):
NOTE: What specific vitals do you want taken and recorded?
NOTE: Sitting or standing blood pressure and if sitting, 5, 10, 15 min sitting?
Contact MD if:
Standard criteria:
 Temp greater than 101
 HR greater than 100 or less than 50
 BP greater than 160/90 or less than 90/50
 RR greater than 24 or less than 12
NOTE: List CRITERIA to use to determine if there is a problem and ACTION to take if criteria met. (see
example of standard criteria above)
5.
CRU staff obtain height (inches/cm) and weight (lbs/kg) (w/out shoes & jacket/coat) and record on Flow
sheet.
NOTE: clarify if want measured in cm/inches or kg/lbs.
6. CRU RN insert PIL for venous blood draws.
NOTE: If subject prefers, individual blood draws, as opposed to PIL, it can be done.
NOTE: PIL may not be needed for single blood draw.
#811 Day 1 Treatment Week 18 10.18.10 kc
Always put version date of draft orders and drafter’s initials
1
SAMPLE TEMPLATE FOR OP BLOOD DRAW VISIT WITH KIT
7.
CRU staff to collect the following labs, enter draw time, and send to NMH lab/CRU lab. Kit has blue dot.
NOTE: list WHERE samples to be sent, TIME frame for samples
NOTE: if using a Kit, describe kit (blue dot).
BLOOD:
 1 (8.5 mL) tiger top SST tube for chemistries, TSH, free T4 & Total insulin (Immediately
place on wet ice / Immediately protect from light with aluminum foil / Process within 30
minutes / Handle at room temperature / Send STAT to
)
 1 (3 mL) lavender top/EDTA tube for hematology
 1 (10 mL) lavender top/EDTA tube for HCV-PCR Tip gently 6 to 8 times
 1 (5 mL) gold top (SST) tube for serum pregnancy (if subject female) – SEND STAT to
NMH lab
 1 (4.5 mL) light green lithium heparin tube for blood alcohol level – Tip gently 6 to 8 times
and SEND STAT to NMH lab
URINE:
 Urine drug/alcohol screen to NMH lab
NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place
on ice/process within 30 minutes, etc) and where to send each sample)
NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance.
NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins,
creatinine clearance)
8.
Notify MD if:
 Pregnancy test is positive or inconclusive
9.
Study Coordinator to:
 Assess AEs and Conmeds
 Administer SF-36, HCV QoL, and EQ-5D
 Pick up study drug from pharmacy and dispense to subject
NOTE: if administer medication while subject is on unit OR if sending medication home with the subject, there
must be a discharge item on the Orders about instructing subject on
 What symptoms to look for and steps to take post D/C (e.g. if have temperature over 101.5, call
PI)
 How to take study medications at home
10. CRU RN D/C PIL if one was placed.
11. Discharge subject from Outpatient CRU, if stable
NOTE: Orders should include the discharge of subject.
Page Flamm (MD) 5-0000 for questions regarding study.
NOTE: List PI or Attending physician who should be called for questions about study.
DAY 1 / TREATMENT WEEK 19 Date: ______________ Pt. Study #: _____________
NOTE: need a set of orders for each day the subject is at CRU
NOTE: If multiple visits will have duplicate orders, you can combine orders and list the visits. Leave a line for the
nurse to fill in the actual date.
1.
2.
Admit subject to CRU Outpatient.
CRU Staff to obtain vital signs (sitting blood pressure, heart rate (bpm), respiration rate and oral
temperature):
NOTE: What specific vitals do you want taken and recorded?
Contact MD if:
Standard criteria:
 Temp greater than 101
 HR greater than 100 or less than 50
 BP greater than 160/90 or less than 90/50
#811 Day 1 Treatment Week 18 10.18.10 kc
Always put version date of draft orders and drafter’s initials
2
SAMPLE TEMPLATE FOR OP BLOOD DRAW VISIT WITH KIT
 RR greater than 24 or less than 12
NOTE: List CRITERIA to use to determine if there is a problem and ACTION to take if criteria met. (see
example of standard criteria above)
3. Page Dr.Flamm pager (5-000) to: perform GI/liver exam.
4. CRU staff obtain weight (w/out shoes & jacket/coat) and record on Flow sheet.
NOTE: clarify if want measured in cm/inches or kg/lbs.
5. CRU RN insert PIL for venous blood draws.
NOTE: If subject prefers, individual blood draws, as opposed to PIL, it can be done.
NOTE: PIL may not be needed for single blood draw.
6.
CRU staff to collect the following labs, enter draw time, and send to NMH lab/CRU lab. Kit has blue
dot.
NOTE: list WHERE samples to be sent, TIME frame for samples
NOTE: if are using a Kit and describe kit (blue dot).
BLOOD:
 1 (8.5 mL) tiger top SST tube for chemistries, TSH, free T4 & Total insulin (Immediately
place on wet ice / Immediately protect from light with aluminum foil / Process within 30
minutes / Handle at room temperature / Send STAT to
)
 1 (3 mL) lavender top/EDTA tube for
 1 (5 mL) gold top (SST) tube for serum pregnancy (if subject female) – Tip gently 6 to 8
times and SEND STAT to NMH lab
NOTE: must list number of samples, (amt of sample) tube type, type of draw and any draw instructions (place
on ice/process within 30 minutes, etc) and where to send each sample)
NOTE: if a kit is to be used, the CRU must have the kit 2-3 days in advance.
NOTE: list any additional clinical labs that might be needed (e.g., quantitative immunoglobulins,
creatinine clearance)
7. Study Coordinator to:
 Assess AEs and Conmeds
 Administer SF-36, HCV QoL, and EQ-5D
 Pick up study drug from pharmacy and dispense to subject
8. CRU RN D/C PIL if one was placed.
9. CRU RN/Study Coordinator to instruct subject on how to take study medication.
10. Discharge subject from Outpatient CRU, if stable
NOTE: Orders should include the discharge of subject.
Page Flamm (MD) 5-0000 for questions regarding study.
NOTE: List PI or Attending physician who should be called for questions about study.
#811 Day 1 Treatment Week 18 10.18.10 kc
Always put version date of draft orders and drafter’s initials
3