Transcript Shoring up Safety in Your IV Room - Idaho Society of Health

Shoring Up Safety in
Your IV Room
Catherine Gundlach, Pharm.D. CPPS
Medication Safety Coordinator
St. Luke’s Boise Meridian
March 5, 2016
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Disclosures
• I have no conflicts of interest to disclose.
• Abbreviations:
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FDA = Food and Drug Administration
BOP = Board of Pharmacy
CMS = Centers for Medicare and Medicaid Services
ISMP = Institute for Safe Medication Practices
• CSPs = compounded sterile preparations
• USP= United States Pharmacopeia
• FMEA = Failure Modes and Effects Analysis
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Learning Objectives
• Identify process risk points that can cause sterile product
compounding errors in the IV room
• Discuss the Institute for Safe Medication Practices (ISMP)
Guidelines for Safe Preparation of Sterile Preparations and
how these practices can be incorporated into work flow.
• List best practice strategies utilized by pharmacy technicians
and pharmacists working in the IV room to minimize errors.
• Explain the importance of pharmacy oversite to ensure the
appropriate compounding of IV products made outside the
pharmacy.
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2006-2008-2012-2014
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Coming Full Circle: 2016
• Smart pumps
• Bedside Barcode Scanning
• Electronic Medical Records
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USP 797
Drug Shortages
Compounding Pharmacies
Technology in IV Rooms
Accreditation oversite in IV rooms
Reference 1,2
• Clinical Pharmacists
• To Err is Human 1999
• Error Reporting and Medication Safety Automation
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• Idaho BOP Sterile Compounding Requirement. To engage in the
practice of sterile compounding a minimum of one of the CPE
hours obtained (0.1 CEU) must be ACPE accredited and related to
the practice of sterile compounding.
• April 2015 BOP Rules:
• 239 Compounding Drug Products
• 240 Sterile Product Preparation (pages 47- 51)
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Joint Commission Standards
CMS Condition of Participation (CoP) for Pharmaceutical Services
FDA
Drug Quality and Security Act 2013
ISMP Guidelines
Reference 7, 8, 9, 10, 14
Sterile compounding Safety ?
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Reference 8
Pharmaceutical Services: Revisions were made to portions
of the pharmaceutical services CoP to bring them into
alignment with current accepted standards of practice. To
improve clarity, the revised guidance addresses: accepted
professional pharmacy principles, including United States
Pharmacopeia (USP) standards; compounding of
medications, particularly compounded sterile
preparations (CSPs); determining beyond-use dates
(BUDs); safe and appropriate storage and use of
medications; and, policies and procedures related to highalert medications and minimizing drug errors.
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Safety in the IV Room
• What kinds of errors can occur = risk points
• Guidance for Practice
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USP 797, 795, 800
The Joint Commission Standards
CMS
ASHP
ISMP Guidelines
Board of Pharmacy
Compounding Pharmacies (503A)
• Practice recommendations from the field
Technicians and Pharmacists
• Compounding outside of the pharmacy
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Risk Points for CSPs
• Sound Alike Look Alike Drugs
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Confirmation Bias:
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Risk Points for CSPs
• High Alert Medication Categories (ISMP)
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Anticoagulants
Thrombolytics
Chemotherapy
Epidural medications
Insulin
Electrolytes
Parenteral Nutrition
Sterile Water for Injection
Hypertonic Saline
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Risk Points for CSPs
High Alert populations
• Pediatrics
• Geriatrics
• Oncology Patients
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Risk Points for CSPs
• Multiple Concentrations utilized for compounding in IV Room
• Pediatric Compounding
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Coming Your Way on 1/20/16:
Children’s Antibiotic Concentration Changes:
Current Concentration
New Concentration
Cefepime (Maxipime®)
100 mg/ml
40 mg/ml
Ceftazidime (Fortaz®)
50 mg/ml
40 mg/ml
Gentamicin
2 or 10 mg/ml
5 mg/ml
Piperacillin/Tazobactam (Zosyn®)
200 mg/ml piperacillin (225 mg/ml
pip+tazo)
89 mg/ml piperacillin (100 mg/ml
Q: Why are these changes happening?
A. Standardization of how medications are provided decreases the
opportunity for ordering, preparation, and dispensing errors!
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pip+tazo)
New concentrations are compatible with Alaris settings!
All other antibiotics will stay at their current concentration!
Q. Why do some of these new concentrations not match what Neofax recommends?
A. The Treasure Valley pediatric P&T committee reviewed the recommendations from our neonatologists, and multiple pediatric
specialists, to approve these changes. Data was gathered from multiple references as well as our neighboring children’s hospitals in the
region.
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Risk Points for CSPs
• Bulk containers compounded and used to prepare multiple
doses
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Need standard processes
Need double checks
Need detailed labeling
Need Record Keeping
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Risk Points for CSPs
• Production Pressure
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Risk Points for CSPs
• Culture of clarity, culture of safety
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Types of Medication Errors that
Can Occur in the IV room are ?
a.
b.
c.
d.
Wrong diluent utilized for compounding
Wrong drug compounded
Staff do not utilize adequate sterile technique
Wrong expiration date on compounded
product
e. All of the above
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Human Reliability
• Intelligent human beings have an intrinsic error rate of
about 3%
• Perfection is not possible since humans make mistakes
• First step in Culture of Safety: get people to admit they
will might make an error.
“Safety performance is 90% about people and that is what makes it so
simple and so complex”
RA Carillo 2002
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High Reliability and Zero Harm
• High Reliability refers to ability of complex, high-risk industries to go
for long periods of time without accidents
• Leadership commitment
• Culture of Safety
• Robust Process Improvement
Reference 12
• You get to there by:
• Five Characteristics of high reliability organization
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Preoccupation with failure
Reluctance to simplify observations
Sensitivity to operations
Commitment to resilience
Deference to expertise
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Influencing Behaviors at the Sharp End
Design of
Design of
Design of
Policy &
Protocol
Culture
Work
Processes
Design of
Design of
Technology &
Environment
Structure
Behaviors
of Individuals & Groups
“You have to manage a system. The
system doesn't manage itself.”
"A bad system will DEFEAT a
good person every time.“
W. Edwards Deming
W. Edwards Deming
Outcomes
Adapted from R. Cook and D. Woods, Operating at the Sharp End: The Complexity of Human Error (1994)
© 2006 Healthcare Performance Improvement, LLC. ALL RIGHTS RESERVED.
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Poor Safety Health
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Normalization of deviance (workaround becomes the norm)
Doing too much with too little
Not speaking up – no psychological safety
Forgetting to be afraid
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Errors and Quality Improvement
• Safety Culture where anyone can “stop the line” .
• Safety Culture where everyone feels like they can report errors
that have occurred or they have caught.
• Errors are openly discussed
• Those doing the work fix process
• Proactive Assessments are undertaken prior to
implementation of process changes (FMEA)
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Hierarchy of Actions to Prevent
Harm
• Stronger Actions
• Intermediate Actions
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Redundancy, increase staffing- or decrease workload
Computer alerts, checklists, education
Standardize communication, eliminate SALADs
Highlight key info on labels
Reference 15
• Physical plant, architecture, engineering controls
• Simplify process, standardize equipment or process
• Tangible leadership involvement
• Weaker Actions
• Double checks
• Training
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CSPs: Guidance for Practice
Must follow USP 797, USP 1066
Must appropriately handle hazardous drugs (USP 800)
Must meet Joint Commission Standards
Must ensure outsourced CSP quality (503b)
Best Safety Practices:
Reference 10, 11
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1.
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Vincristine in minibag not syringe
Oral methotrexate weekly default and verify indication if daily
Weigh each patient in metric
Oral liquids unit dosed by Rx in oral syringes
Oral liquid dosing cups/syringes only metric
Eliminate glacial acetic acid
Segregate, differentiate neuromuscular blockers
IV high alert medications infusion pump with safety software
Antidotes, reversal agents available with protocols
Eliminate 1 liter bags of sterile water for inj or irrigation
When compounding sterile products perform independent
verification of ingredients PRIOR to it’s addition to final
container. Use technology to assist the process.
Reference 11
ISMP Targeted Medication Safety
Best Practices for Hospitals
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Reference 13
The 2016 – 2017 ISMP Targeted Medication
Safety Best Practices stated that when
compounding sterile preparations, perform
an independent verification to ensure that the
proper ingredients are added, including
confirmation of the proper amount (volume)
of each ingredient prior to it’s addition to the
final container.
• True
• False
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ISMP Guidelines for Safe
Preparation of Sterile Compounds
• Policies/Procedures
• Order entry and
verification
• Drug Storage
• Assembling Drugs
and Supplies
• Compounding
• Drug Conservation
• Source/Bulk Containers
• Technology/Automation
• Quality control/final
product verification
• Product Labeling
• Record Keeping
• Staff Management
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ISMP CSP Guidelines
Policies and Procedures
• Comply USP 797
• Well defined
• Standardize workflows
and Quality control
• Drug conservation for
shortages
• Batching processes
Order Entry and
Verification
• Orders RPh verified
• Transcription verified by
second RPh (chemo, TPNs)
• For TPNs sequence of
ingredients on order sets or
screens matches the
compounder and labels
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ISMP CSP Guidelines
Drug Storage
• Not too much stock
• Enough space
• Isolate concentrated
electrolytes
• Bins have generic and
trade names, TALLman
• CSPs waiting for check
are in defined area
• USP 1066
Assembling Products
• Drug, supplies separated
for each dose/batch
• When possible person
gathering is different
from person
compounding.
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ISMP CSP Guidelines: compounding
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Commercial products used if available
Standard base solutions
Outsourcing: careful consideration of what and who
Standard Operating Procedures in IV room
Formulas for complex compounding and worksheets,
preparation labels etc.
Limit hood and product traffic as appropriate
Separate adult-pediatric compounding
Chemo prepared by qualified staff
Overfill rules
Standard process for prep and check of bulk containers
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ISMP CSP Guidelines
Technology/Automation
• Need a strategic plan
• Use to assist verification
process (barcode
scanning of ingredients
or IV robotics)
• Routine maintenance
• Current versions of
software
Automated
Compounding Devices
• Process for who has access
to change database
• Only RPh overrides alerts
• Barcode scanning for set up
• Tubing traced
• Staff training documented
• Delivers all ingredients
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ISMP CSP Guidelines
Quality Control
Product Labeling
• Staff feel psychologically
safe and speak up
• Do not use proxy
methods of verification
• Errors that occur during
compounding are
documented and
reported
• Best practices are
reviewed and applied as
appropriate to IV room
• ISMP Guidelines
• Applied after manual
compounding
• IV compounder labels
match format of order
• Chemo label has final
volume to be infused
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ISMP CSP Guidelines
• Staff Management
• Certified Technicians
• Technicians and Pharmacists preparing CSPs
undergo comprehensive orientation and
ongoing competency assessment.
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The ISMP Guidelines for Sterile
Preparation and Compounding include
best practice recommendations related
to drug storage, preparation of bulk
containers, technology and automation,
record keeping and staff management.
• True
• False
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Compounding done outside Pharmacy
Joint Commission & CMS will look at processes
around immediate use CSP preparation:
1. Simple transfers of nonhazardous drugs
2. CSP is used within an hour
3. Sterile technique is utilized. Designated clean
compounding area. MDV do not move between
patient rooms
4. If not used immediately, product is labeled
(ingredients, prepared by, expiration date)
5. Staff training and periodic competency assessment
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Pharmacy oversite of sterile product
compounding done outside of pharmacy
in urgent situations should include:
a. Staff training on proper use of aseptic
technique
b. A designated compounding area that is clean
c. Verification that products are being labeled
when compounded
d. Periodic competency assessment of staff
e. All of the above
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Ask IV Room Subject
Matter Experts:
n = 10
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How do you ensure accurate communication ?
How do you get clarity on complicated orders/compounds ?
How do you keep your workflow uncluttered and organized ?
What kind of training do you think is key ?
How do you handle fatigue and production pressure ?
What in your environment is really important?
How are policies and procedures helpful to you ?
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How do you ensure accurate
communication ?
• Verbal face to face for important information that may not be
clear on the label.
• Look for verbal and non-verbal clues for understanding.
• Don’t send important information via e-mail.
• Go to the source for clarity on label: talk to pharmacist who
entered the order.
• Write down requests, comments and reminders. When it’s busy
you can’t remember everything.
• All orders are reduced to writing. If something changes then you
need a new order.
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How do you get clarity on complicated
orders/compounds ?
• Speak directly with compounding technician if it’s an
uncommon IV or there’s a common mistake with that IV.
• Repeat back verbal instructions.
• Do not proceed until you’re sure what to do
• Get clarity by asking.
• Clarity is achieved when experienced techs with critical
thinking realize and bring up:
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It’s odd I’m using 6 vials to make a dose instead of one
It’s odd that it is in D5W instead of NS
This seems like a lot bigger dose than I usually see
This regimen usually has atropine as a pre med but I don’t see a
label for that
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How do you keep your workflow
uncluttered and organized ?
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Clean workspace regularly to avoid overfilling the hood.
Pick up trash and clutter as I work.
Don’t multitask.
Standardize processes and de-clutter.
Work from left to right and work on one thing at a time that’s in
front of you.
Concentrate on only what is directly in front of me.
Keep work area organized and maintain a clean desk.
Establish a routine and workflow sheet to keep on task.
Technicians use trays to keep compounds separated and organized.
Need to make sure bulk compounding doesn’t pile up and clutter IV
room areas.
Know workload and when items due is key.
Keep checklists for TPN patients.
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What kind of training do you think is key
to be able to do this work well ?
• Combination of written, hands on and face to face. Must be
able to demonstrate competency.
• Need many hours in IV room as intern/technician/pharmacist
to maximize exposure to products and technical skills.
• Must also know references to use (compatibility, stability).
• Time with mentor and shadowing (pair senior with novice).
• Checklists for key tasks (like RPh check) so all steps followed
and they become a habit.
• Good sense for workflow and when things are due.
• Juggling, triage and a smile.
• Spending time with expert technician is key and getting
background thoroughly explained by expert pharmacist.
• Learn from mistakes- know what to look out for.
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How do you handle fatigue and
production pressure ?
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Come to work well rested and ready to work.
Drink water and take breaks outdoors, step away 3-5 mins.
Ask for help when the ship starts to go down ASAP.
Keep managers in the loop.
Avoid hero complex- avoid mind set of “working harder” as that
leads to working faster and sloppier.
Help technicians triage work and remove things that do not need
to be done right away.
Stay aware of due times.
Do not let production pressure cause you to surpass comfort level.
Before entering IV room to work have a snack and use restroom.
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What in your environment is really
important ?
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Minimize interruptions and NOISE.
Co-workers who get the job done and use time appropriately.
Standing desk in the IV room.
Adequate lighting and quiet.
Equipment and computers that function at all times.
Inventory stock to meet demand.
Technicians with good attention to detail and critical thinking.
Staffing- do not leave shifts uncovered as they creates unsafe
stress for staff remaining to meet production.
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How are policies and procedures
helpful to you ?
• Keep them short and readily available and
up to date.
• Test them on novice and experts prior to
final approval.
• Have clarity so staff can adhere to standard.
• Need culture where adherence to policies is
the standard and “drift” is not allowed.
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Practice Recommendations by IV room
technicians/pharmacists to ensure
accurate compounding include:
a. Repeat back verbal instructions to ensure accuracy
b. Follow clear and well defined policies and procedures
to ensure there is not drift from these
c. When checking an IV product, focus on one product at
a time
d. Minimize noise and interruptions
e. All of the above
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Summary: create a robust
culture of safety in your IV room
• Follow standards of practice for compounding
sterile preparations.
• Know your risk points for errors.
• Retrospective: Carefully analyze your errors and
engage your team (subject matter experts*) in
process improvement.
• Engage your leadership.
• Prospective: perform gap analysis of best safety
practices for compounding sterile preparations
vs your current practice.
* IV Committee
Questions, Comments, Suggestions ?
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Bibliography
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5.
6.
7.
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9.
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12.
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14.
15.
Institute of Medicine. To Err is Human: Building A Safer Health System. November 1999.
http://iom.nationalacademies.org/reports/1999/to-err-is-human-building-a-safer-health-system.aspx
USP. General Chapter <797> Pharmaceutical Compounding of Sterile Preparations.
ASHP. Guidelines on Compounding Sterile Preparations.
http://www.ashp.org/DocLibrary/BestPractices/PrepGdlCSP.aspx
USP. <795> Pharmaceutical Compounding- Nonsterile Preparations.
USP. General Chapter <1066> Physical Environments that Promote Safe Medication Use.
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/gc1066PhysicalEnvironments.pdf
USP. General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings (proposed chapter).
http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf
Idaho Board of Pharmacy Rules. Rule 240 Sterile Product Preparation.
http://adminrules.idaho.gov/rules/current/27/0101.pdf
Centers for Medicare & Medicaid. Revised Hospital Guidance for Pharmaceutical Services and
Expanded Guidance Related to Compounding of Medications. 10-30-2015.
https://www.cms.gov/Medicare/Provider-Enrollment-andCertification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-01.pdf
ISMP. Technology and error-prevention strategies: Why are we still overlooking the IV room? ISMP
Medication Safety Alert. January 15, 2015 Vol 20 Issue 1.
ISMP. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit. 2013.
https://www.ismp.org/tools/guidelines/IVSummit/IVCGuidelines.pdf
ISMP. 2016 – 2017 Targeted Medication Safety Best Practices for Hospitals.
http://www.ismp.org/tools/bestpractices/TMSBP-for-Hospitals.pdf
The Joint Commission. High Reliability: The Path to Zero Harm.
http://www.jointcommission.org/assets/1/18/HC_Exec_article.pdf
Pedersen CA, et al. Am J Health-Syst. Pharm. 2015;72;1119-37
FDA. Outsourcing Facilities and section 503B.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm
393571.htm
NPSF. RCA2: Improving Root Cause Analysis and Actions to Prevent Harm.
http://www.npsf.org/?page=RCA2
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Practice Recommendations by IV room
technicians/pharmacists to ensure
accurate compounding include:
a. Repeat back verbal instructions to ensure accuracy
b. Follow clear and well defined policies and procedures
to ensure there is not drift from these
c. When checking an IV product, focus on one product at
a time
d. Minimize noise and interruptions
e. All of the above
51
Types of Medication Errors that
Can Occur in the IV room are ?
a.
b.
c.
d.
Wrong diluent utilized for compounding
Wrong drug compounded
Staff do not utilize adequate sterile technique
Wrong expiration date on compounded
product
e. All of the above
52
The 2016 – 2017 ISMP Targeted Medication
Safety Best Practices stated that when
compounding sterile preparations, perform
an independent verification to ensure that the
proper ingredients are added, including
confirmation of the proper amount (volume)
of each ingredient prior to it’s addition to the
final container.
• True
• False
53
The ISMP Guidelines for Sterile
Preparation and Compounding include
best practice recommendations related
to drug storage, preparation of bulk
containers, technology and automation,
record keeping and staff management.
• True
• False
54
Practice Recommendations by IV room
technicians/pharmacists to ensure
accurate compounding include:
a. Repeat back verbal instructions to ensure accuracy
b. Follow clear and well defined policies and procedures
to ensure there is not drift from these
c. When checking an IV product, focus on one product at
a time
d. Minimize noise and interruptions
e. All of the above
55