Clinical Safety & Effectiveness
Improvement of Chemotherapy Order Preparation Process
to Improve Patient Safety in the Gyn Onc Center
DATE
1
The Team
• Team Members
–
Judith Smith, Pharm.D., BCOP, FCCP, FISOPP
Associate Professor, Department of Gynecologic
Oncology and Reproductive Medicine, Division of
Surgery
–
Tracy Spinks, B.B.A.
Project Director, Institute for Cancer Care Excellence
–
Elizabeth Garcia, RN, MPA
Clinical Administrative Director, Gynecologic Oncology
Center
• Facilitator
–
Russell Content, MBA
Clinical Business Manager, Gynecologic Oncology Center
• Sponsor
–
Charles Levenback, M.D.
Professor & Deputy Chair, Department of Gynecologic
Oncology and Reproductive Medicine, Division of
Surgery
Medical Director, Gynecologic Oncology Center
2
Our Why
• 37 year old female
– Mother of two girls
• 2 weeks post partum
– Curable cancer
– Admitted for Bleomycin, Etoposide, Cisplatin (BEP)
Our Why
• Orders prepared, reviewed & signed off
– Advance Practice Nurse
– Fellow
– Attending
• Orders dispensed
– Two pharmacists checked
• Orders Administered
– Two Registered Nurses
• Patient Rounded on daily
–
–
–
–
Advance Practice Nurse
Clinical Pharmacist
Fellow
Attending
Our Why
• Orders prepared, reviewed & signed off
– Advance Practice Nurse
– Fellow
– Attending
• Orders dispensed
– Two pharmacists checked
• Orders administered
– Two Registered Nurses
• Patient rounded on daily
–
–
–
–
Advance Practice Nurse
Clinical Pharmacist
Fellow
Attending
Cisplatin dose was a 4x
overdose
• Suppose to be: 20 mg/m2 x 5 days
• Written: 75 mg/m2 x 5 days
• Error was not caught until Day 5
just prior to last scheduled dose
Our Why
• Orders prepared, reviewed & signed off
– Advance Practice Nurse
– Fellow
– Attending
• Orders dispensed
– Two pharmacists checked
• Orders administered
– Two Registered Nurses
Cisplatin dose was a 4x
overdose
• Suppose to be: 20 mg/m2 x 5 days
• Written: 75 mg/m2 x 5 days
• Error was not caught until Day 5
just prior to last scheduled dose
• Patient rounded on daily
–
–
–
–
Advance Practice Nurse Patient HARM:
Clinical Pharmacist
• Acute renal toxicity
Fellow
Attending
• Plasma pheresis & hospital admission x 10 days
• Permanent hearing loss
We have a
problem….
….it is time for
change.
Timeline
Chemo Labs check
box, ATC
scheduling 3hr
block
Independent second
check education;
Chemotherapy
Standard Doses &
references database
CSE Interventions
* Mar ‘11 –Jun ‘11
Third Interventions
Dec ’10- Jan ‘11
Second Interventions
Aug ‘10 – Oct ‘10
First Interventions
* Feb ‘10 – May ‘10
Sentinel Event
1/16/2010
On Call Schedule
Updated; Patient Safety
Lectures; Chemotherapy
Competency Launched
What are we trying to accomplish?
Improve patient safety
when receiving
chemotherapy
No chemotherapy errors
reaching our patients
9
What are we trying to accomplish?
Improve patient safety when receiving chemotherapy

Aim statement


Rationale


To decrease the number of gynecologic oncology
chemotherapy order set clarifications by 20% by July
2011.
Decreasing chemotherapy order set clarifications will
reduce the likelihood of a chemotherapy error reaching
the patient  Get it right the first time.
Business Case

To decrease associated financial and emotional costs
with chemotherapy error reaching patient.
10
Process Analysis
Patient arrives
at Gyn Ctr
Send patient
for labs
Check in
patient
Triage
patient
No
RN
assessment
Current
labs?
Chemo
education
Chemo
education
Yes
Patient
assessment
Present to
Attending
Patient
examined
Discuss
regimen with
patient
Patient
consent
Review labs
weight, etc.
Prepare
Order Set
in EMR
Save Order
Set
Verify
Order Set
Review
Mid-Level
assessment
Gyn Ctr
Receptionist
Clinic Nurse/
Aid
Primary
Mid-Level
Attending
Physician
Secondary
Mid-Level
Clinic
Pharmacist
Patient
examined
Discuss
regimen with
patient
New Yes
regimen?
Chemo
education
Verify and
sign Order
Set
No
Send Order
Set to ATC
Process Analysis
Patient arrives
at Gyn Ctr
Send patient
for labs
Check in
patient
Triage
patient
No
RN
assessment
Current
labs?
Chemo
education
Chemo
education
Yes
Patient
assessment
Present to
Attending
Patient
examined
Discuss
regimen with
patient
Patient
consent
CS&E Focus
Review labs
weight, etc.
Prepare
Order Set
in EMR
Save Order
Set
Verify
Order Set
Review
Mid-Level
assessment
Gyn Ctr
Receptionist
Clinic Nurse/
Aid
Primary
Mid-Level
Attending
Physician
Secondary
Mid-Level
Clinic
Pharmacist
Patient
examined
Discuss
regimen with
patient
New Yes
regimen?
Chemo
education
Verify and
sign Order
Set
No
Send Order
Set to ATC
Process Analysis
People
Policy
Lack of knowledge
Communication
Lack of financial clearance for chemotherapy
Confusion with Gyn Onc "on-call" schedule
Missing documentation for abnormal lab values on order
Cleared for chemotherapy prior to labs back
Attending late to clinic
Double-check of chemotherapy order is not
independent
Morale of Clinic
Attending not re-calculating doses
RN interrupts in clinic to answer non-urgent
patient telephone calls
Mulitple people preparing order
Including business center in treatment planning
Multiple providers giving chemotherapy education to patient
Paging too many people for one clarification / question
Mid-levels seeing more than one patient at time
Multi-tasking
Mid-levels holding onto charts until end of day to dictate
Information Overload
Problem Statement
Creating carboplatin dosing standards
Carboplatin in NS "on-call" for pharmacy to prepare
Verifier not re-calculating carboplatin doses
Labs not being ready
Distractions while completing order
No breaks all day
No place quiet to sit
.
Environment
Staff shortages
Mid-levels holding onto charts until end of day to dictate
Morale of Clinic
Excessive socializing /
visiting in workroom
Over booking template
Turnover in trainees and knowing info
about chemo / process
Order sets timing out
Preparing chemotherapy orders for patient never seen/met
Time between clinic appt and ATC
appt time for chemotherapy too
short
Rare tumors and unfamiliar regimens
Resources
To decrease the number
of times a gynecologic
oncology chemotherapy
order has to be reworked
by 20% by July 2011.
Process Analysis
People
Policy
Lack of knowledge
Communication
Lack of financial clearance for chemotherapy
Confusion with Gyn Onc "on-call" schedule
Attending late to clinic
Missing documentation for abnormal lab values on order
Cleared for chemotherapy prior to labs back
Double-check of chemotherapy order is not
independent
Morale of Clinic
Attending not re-calculating doses
RN interrupts in clinic to answer non-urgent
patient telephone calls
Mulitple people preparing order
Including business center in treatment planning
Mid-levels seeing more than one patient at time
Multi-tasking
mid-levels holding onto charts until end of day to dictate
Information Overload
Multiple providers giving chemotherapy education to patient
Paging too many people for one clarification / question
Problem Statement
Creating carboplatin dosing standards
Carboplatin in NS "on-call" for pharmacy to prepare
Verifier not re-calculating carboplatin doses
Labs not being ready
Distractions while completing order
No breaks all day
No place quiet to sit
.
Environment
Staff shortages
mid-levels holding onto charts until end of day to dictate
Morale of Clinic
Excessive socializing /
visiting in workroom
Over booking template
Turnover in trainees and knowing info
about chemo / process
Order sets timing out
Preparing chemotherapy orders for patient never seen/met
Time between clinic appt and ATC
appt time for chemotherapy too
short
Rare tumors and unfamiliar regimens
Resources
To decrease the number
of times a gynecologic
oncology chemotherapy
order has to be reworked
by 20% by July 2011.
Process Analysis
CS&E Intervention
Goal: Labs results available for chemotherapy order process
• Patient Education
– Signage in Gyn Onc Center Lobby
– “Got labs?” button
– Updated "Tips for Convenience"
• Provider Education & Resources
– Education reminder to order labs
– Prompt on order form to order labs with
chemotherapy
CS&E Interventions
Goal: Increase consistency and reduce information overload
• Chemotherapy Education
– Chemotherapy Education Checklist
– Documenting on 1st cycle “Chemotherapy teaching
provided see IPOCTR” under “interventions”
• Chemotherapy Preparation
– Chemotherapy Order Checklist
– Accountability reports
Order set clarifications
What we measured
• Measures:
– Process: Percentage of chemotherapy order sets with
clarifications
– Efficiency: Chemotherapy order processing time
• Create to Accept
– Create to verify
– Verify to Attending sign
• Time was based on 12-hour workday
• Excluded any clarification beyond 20 days from time created
Order set clarifications
What we measured
• Data source:
– EMR reports
– ONLY included chemotherapy order sets
• Only clarifications that were drug-related
– Four twelve-week periods
•
•
•
•
Baseline - 10/26/2009 - 01/15/2010
First Interventions - 03/08/2010 - 05/28/2010
Second Interventions - 10/18/2010 - 01/07/2011
Third (CS&E) Interventions - 03/21/2011 - 06/10/2011
Chemotherapy Clarifications by Period
P-Chart
0.40
Sentinel Event
01/16/2010
CS&E Interventions
03/21/2011
0.20
UCL=.16
CL=.14
UCL=.12
LCL=.11
0.10
CL=.09
First Interventions
03/08/2010 - 05/28/2010
Second Interventions
10/18/2010 - 01/07/2011
CS&E Interventions
03/21/2011 - 06/10/2011
1
2
3
4
5
6
7
8
9
10
11
12
1
2
3
4
5
6
7
8
9
10
11
12
0.00
Baseline
10/26/2009 – 01/15/2010
1
2
3
4
5
6
7
8
9
10
11
12
LCL=.06
1
2
3
4
5
6
7
8
9
10
11
12
Proportion of Order Sets w/ Clarifications by Week
0.30
Week
Chemotherapy Clarifications in
context of clinic volume
Chemotherapy Clarifications in
context of clinic volume
4000
30.0%
Total Number of Clinic Appointments
Number of Chemotherapy Clearance Appointments
3500
Percentage of order sets with clarifications
25.0%
3000
Number of Appointments
20.0%
2500
17.4%
2000
15.0%
12.8%
1500
*
10.4%
*
8.8%*
10.0%
1000
5.0%
500
0
0.0%
Baseline 10/26/200901/15/2010
First Interventions 03/08/2010Second Interventions
05/28/2010
10/18/2010- 01/07/2011
Third (CSE) Interventions
03/21/2011-06/10/2011
49% decrease from the Baseline period to the CS&E intervention period.
Percentage of Chemotherapy Order Clarifications
* p < 0.05 (compared to baseline)
Time Assessment “Create to Accept” (in Hours)
Inside and Outside Clinic Hours
"Create to Accept" (in Hours)
250.00
7.7% w/ Clarifications
25.0% w/ Clarifications
50.00
25.00
0.00
Inside Clinic Hours
Median Time – Orders w/ Clarifications
Outside Clinic Hours
Median Time – Orders w/ No Clarifications
Third (CS&E) Interventions - 03/21/2011 - 06/10/2011
Average Time – All Orders
It’s not a matter of rushing…..
Time assessment PRIOR to order being sent to ATC Pharmacy
Orders Without Clarifications
• Baseline:
– Create to Verify: 14 minutes
– Verify to Signed: 25 minutes
– TOTAL: 39 minutes
p > 0.05, NS
Orders Without Clarifications
• CSE Interventions
– Create to Verify: 15 minutes
– Verify to Signed: 15 minutes
– TOTAL: 30 minutes
p > 0.05, NS
Orders With Clarifications
• Baseline:
– Create to Verify: 16 minutes
– Verify to Signed: 22 minutes
– TOTAL: 38 minutes
Orders With Clarifications
• CSE Interventions
– Create to Verify: 14 minutes
– Verify to Signed: 15 minutes
– TOTAL: 29 minutes
Annual Time Assessment for
Chemotherapy Order Clarifications
Return on Investment
Project Summary Report
Annual Project Costs
Annual Project Savings/Increase in Revenue
Project Labor
Costs (Yr 0)
Revenue (Yr 0)
Team Member Time
$42,198 Increased Revenue
$0
Total Project Labor Costs
$42,198 Hard Savings
$0
Implementation Costs
Supply
Total start-up costs
Sustainment Costs
Total Costs
ROI
Soft Savings/Increased Productivity
$202 Time relieved but no actual
$466,922
reduction in FTEs.
$202
$0
$42,401 Total Savings
$466,922
1001%
Return on Investment
Project Summary Report
Annual Project Costs
Annual Project Savings/Increase in Revenue
Project Labor
Costs (Yr 0)
Revenue (Yr 0)
Team Member Time
$42,198 Increased Revenue
$0
Total Project Labor Costs
$42,198 Hard Savings
$0
Implementation Costs
Supply
Total start-up costs
Sustainment Costs
Total Costs
Soft Savings/Increased Productivity
$202 Time relieved but no actual
$466,922
reduction in FTEs.
$202
$0
$42,401 Total Savings
ROI
$466,922
1001%
Equals $167 saved per chemotherapy order
Lessons Learned
• Educational interventions reduced number of
clarifications
– It was not a matter of time spent on order
preparation
• Data does not support rationale that “rushing”
contributing factor
• Times of day with limited resources increases
risk for clarifications/errors
Next steps
Next steps
• In Department Gynecologic Oncology:
– Faculty complete chemotherapy competency
• Develop annual re-assessment tool
• Develop specific assessment tool for level III
– Define set hours for writing chemotherapy orders
• Between 8 AM to 5 PM
• Monday – Friday
• At Institutional Level:
– Proposal being considered for implementation
• Chemotherapy competency
• Restricting hours for writing elective/non-emergent chemotherapy
orders
Acknowledgements
Team of Stakeholders
– Physicians
• Shannon Westin, M.D., MPH
• Larissa Meyer, M.D. , MPH
• Judith Wolf, M.D.
– Pharmacists
• Benjamin Yee, RPh
• Ginger Langley, Pharm.D.,
BCPS, CPHQ
– Patient Advocate
• Ashley Dubbelde, B.A.A.S.
– Nursing:
• Kimberly Burns, RN, WHNP
• Sandy Knight, RN, CPON
• Donna Branham, RN
– EMR Development &Support
• Karl Jonsson, B.S.
– Business Center:
• Linda Beardon, RN, CHAM
– Administrative Support:
• Marisa Ortega, CPS
• Dana Hedge
Patient
Safety
…chemotherapy safety
putting together the
pieces of the puzzle….
Thank you!
jasmith@mdanderson.org