1. Preventing Pediatric Intravenous Extravasation Injuries
Neil Johnson, MD
Barb Tofani, RN, MSN
Sylvia Rineair, RN, MSHA, VA-BC
Mary Haygood, RN, BSN (Retired)
Julie Stalf, RN, MSN, VA-BC
Darcy Doellman, MSN, RN, CRNI, VA-BC
March, 2014

2. Objectives High Level Overview: Our 4 Components
Cincinnati’s 4 Year Intra Venous Extravasation Harm Reduction Initiative
Our 4 Components
Reliable Hourly Bedside PIV Checks
Evidence Based 3 Tier Medication Tissue Toxicity List
“No Grade” 2 Component Assessment / Documentation Tool
Real Cross-Cultural Leadership
Discussion - Questions

3. Basic Principles It takes a Team Culture change is really hard work
“What would we do for our own children” ?
No-one has all the answers

4. Basic Principles It takes a Team Culture change is really hard work
“What would we do for our own children” ?
No-one has all the answers
What would we do for our own children ?

5. CCHMC Safety Culture

8. CCHMC infusion and Vascular Access Governance (iVAG)
Cabinet Sponsors
Medical Members of Cabinet
Bob Carpenter J.D.
Leadership Group Bi-Monthly
Sylvia Rineair R.N
Mary Haygood R.N.
Tracey Blackwelder
Darcy Doellman R.N.
Derek Wheeler M.D.
Denise Adams M.D.
Vicki DeCastro, RN
John Hingl RPH
Ranjit Chima M.D.
Steve Muething M.D.
Rich Falcone M.D.
Sam Kocoshis M.D.
Lauren Solan M.D.
Barb Tofani R.N.
Neil Johnson M.D.
Permanent Working Groups
Ad-Hoc Working Groups
Tofani
Doellman / Rineair
Doellman
Johnson
Rineair / Stalf
Johnson / Tofani
Tofani / Johnson
Johnson / Haygood / DD
Devices
Operations and Safety
Blood Stream Infections
Process Improvement and Monitoring
Training
Education
Public Relations
Research
Example:
PIV Infusion
Working Group
R/Y/G List 6
Weeks
January 25, 2011

9. CCHMC infusion and Vascular Access Governance (iVAG)
Cabinet Sponsors
Medical Members of Cabinet
Bob Carpenter J.D.
Leadership Group Bi-Monthly
Sylvia Rineair R.N
Mary Haygood R.N.
Tracey Blackwelder
Darcy Doellman R.N.
Derek Wheeler M.D.
Denise Adams M.D.
Vicki DeCastro, RN
John Hingl RPH
Ranjit Chima M.D.
Steve Muething M.D.
Rich Falcone M.D.
Sam Kocoshis M.D.
Lauren Solan M.D.
Barb Tofani R.N.
Neil Johnson M.D.
Permanent Working Groups
Ad-Hoc Working Groups
Tofani
Doellman / Rineair
Doellman
Johnson
Rineair / Stalf
Johnson / Tofani
Tofani / Johnson
Johnson / Haygood / DD
Devices
Operations and Safety
Blood Stream Infections
Process Improvement and Monitoring
Training
Education
Public Relations
Research
Example:
PIV Infusion
Working Group
R/Y/G List 6
Weeks
January 25, 2011

10. Definition HARM Institute for Healthcare Improvement (IHI)
“Unintended physical injury resulting from ….medical care…”
Canadian Disclosure Guidelines (JAMA 2012 Vol 307 #20)
“an outcome that negatively affects a patient’s health / quality of life…”

11. CCHMC I/V Extravasation HARM
“hVAG”
OUTCOME or
TREATMENT
Based

12. Definition SAFETY Institute of Medicine (2000):
“….no commonly accepted definition of the safety net exists…..”
Institute of Medicine,2000 America’s Health Care Safety Net: Intact but Endangered. National Academy Press p3-4

13. Definition (CCHMC Vascular Access Team )
SAFETY:
The Processes, Policies, People and Systems which seek to:
MINIMIZE Necessary Risk
AVOID Unnecessary Risk

14. Definition “NOTHING in Life or Medical Practice is Risk Free”
SAFETY: (CCHMC Vascular Access Team )
The Processes, Policies, People and Systems which seek to:
MINIMIZE Necessary Risk
AVOID Unnecessary Risk
“NOTHING in Life or Medical Practice is Risk Free”
The ONLY way to achieve Zero Risk is to close the Hospital

15. “PIV” Peripheral Intravenous
A “simple” device for administration of medical fluids directly into a peripheral vein
A simple procedure not worthy of the attention of an MD
Common Medical Procedure
70 – 80% of Hospital Inpatients

16. When A PIV Goes Wrong Extravasation:
Inadvertant Deposition of Intended Intravenous Fluids Into Surrounding Tissues
Source: Google Image Search

17. Terminology: Extravasation (Vs Infiltration)
Cincinnati Only Uses “EXTRAVASATION”
EXTRA = “Out Of or Outside”
VASCULAR = “Vessel”
EXTRAVASATION = “Out of the Vessel”
“Infiltration”
Better used to describe purposeful subcutaneous injection of fluids
Example:
“The skin was infiltrated with local anesthetic solution before incision”

18. PIV Extravasation Basic Mechanisms of Injury VOLUME
“Simple” PIV Fluids Leak into Subcutaneous Tissues
Pressure Compresses Local Veins and later, Arteries
Reduces then Blocks Blood Supply To The Limb

19. PIV Extravasation Basic Mechanisms of Injury LOCAL TISSUE TOXICITY
VOLUME
Pressure Compresses Arteries and Veins Reducing Blood Supply To The Limb
LOCAL TISSUE TOXICITY
Chemical: Acid – Base (pH)
Osmolality [H2O]
Biological Activity “Drugs doing what Drugs do”
Vasoactive Drugs
Chemotherapy
VOLUME (Pressure)
TOXICITY
Chemical (pH – Acid/Base)
Osmolality
Biological Activity

20. Mechanisms of Extravasation Injury
VOLUME
Massive Amounts of I/V Fluid in Tissues
Compartment Syndrome
Fluid Pressure Occludes Veins
Venous Occlusion  More Swelling
Progressive Swelling  Arterial Compromise
Dead Limb
Google Images
Our WORST Extravasation Injury was caused by Normal Saline
VOLUME (Pressure)
TOXICITY (Local Tissue)
Chemical (pH – Acid/Base
Osmolality
Biological Activity

21. Mechanisms of Extravasation Injury
TOXICITY: Chemical (Acid / Base)
pH Acid – Base [H+]
Blood pH = 7.4
High or Low pH
Damages Proteins and Kills Cells
pH = 12
Google Images
pH = 2
pH = 11
VOLUME (Pressure)
TOXICITY (Local Tissue)
Chemical (pH – Acid/Base
Osmolality
Biological Activity

22. Mechanisms of Extravasation Injury
OSMOLALITY:
Non-Isotonic Solutions Destroy Cells / Tissue
EXAMPLES: TPN, 8.4% Na Bicarbonate, 20% Dextrose
Blood
Source: Wikipedia
VOLUME (Pressure)
TOXICITY (Local Tissue)
Chemical (pH – Acid/Base
Osmolality
Biological Activity

23. Mechanisms of Extravasation Injury
BIOLOGICAL ACTIVITY:
Vasopressors (Epinephrine / Dopamine)
CONSTRICT Vessels
Chemotherapy Drugs
KILL Cells
Other
“Drugs doing what they are supposed to do”
Journal of Hand Surgery
Vol 36, Issue 12, Dec pg:
VOLUME (Pressure)
TOXICITY (Local Tissue)
Chemical (pH – Acid/Base
Osmolality
Biological Activity

24. Preventing PIV Extravasation Injuries
Two Simple Ideas
AVOID Unnecessary Risk
Give Tissue Toxic Drugs Centrally
MINIMIZE Necessary Risk
Catch Extravasations Early
Use Oral Medications When Indicated

25. Preventing PIV Extravasation Injuries
Two Simple Ideas
AVOID Unnecessary Risk
Give Tissue Toxic Drugs Centrally
MINIMIZE Necessary Risk
Catch Extravasations Early
Use Oral Medications When Indicated
“It’s not that simple”

26. CCHMC Modified INS Extravasation Grading
“Give Tissue Toxic Drugs Centrally” - But What Is A Tissue Toxic Drug ?
CCHMC Modified INS Extravasation Grading

27. Where Do I Find The Official INS List Of “Vesicants”?
There Isn’t One !
“Each Institution Develops Its Own”
Each CCHMC Nursing Subspecialty Had Its Own
“We Know One When We See One”

28. Cincinnati Medication Risk Stratification
18 Month Project
Multi-Disciplinary
Pharmacy
Nursing (VAT)
Physicians
Evidence Based PhD
Nutrition Service
NICU
“rVAG”

29. Medication Risk Stratification
Literature Evidence Search
MEASUREMENT pH
Osmolarity
Measurement of COMMON Pediatric Formulations
Blood Products Excluded
Blood = Bruise
Not Tissue Toxic
RED Criteria
pH <5 or >9
Strong Published Evidence
>950 Mili Osmoles

30. Journal of Infusion Nursing Vol 36, Number 1. Jan/Feb 2013

31. Each Update has a Different Color Border
Available at every clinical workstation

32. Unexpected Positives Universal Availability R/Y/G
Hard To Avoid
At Every Clinical Workstation
Nurses Strongly Influence Doctor Behavior
Trend  Central Access for Red Drugs
Increased Awareness of IV Risks of Red Drugs
“Pseudo Policies” are Sometimes a Positive Phenomenon

33. Preventing PIV Extravasation Injuries
Two Simple Ideas
AVOID Unnecessary Risk
Give Tissue Toxic Drugs Centrally
MINIMIZE Necessary Risk
Catch Extravasations Early
Use Oral Medications When Indicated

34. Journal Pediatric Nursing (2012) 27, 682-689)

35. Hourly PIV Checks Peripheral I/V (PIV) Policy Revision
Nursing Staff Education
Significant Institution-Wide Effort
TLC Methodology for Hourly Checks
Nursing Unit Hourly Checks AUDIT
If >90% Compliance (after 3 months)  STOP Manual Audit
If <90% Compliance  Continue Audit until >90% Achieved
PROBLEMS:
Manual Data Collection
Variable Documentation
Two Electronic Data capture Systems
Reliable Hourly Checks

36. Result: Good But Not Sustained
Reliable Hourly Checks

37. New Efforts: Reliable Hourly Checks
EPIC EMR Implemented
All I/V Documentation now in ONE place
18 month “CVAT” Project with I.T.
All Vascular Access Data Abstraction Project (CVAT)
>60% Extravasation = 1 Month Manual Audit
Unpopular!
Immediate Feedback System
“Personal Interview” (>60%)

38. Immediate PIV Extravasation Feedback System
> 30% volume or R drug extravasation charted in EPIC
Automatic messaging to VAT and Med Director
VAT Team nurse visits bedside 24/7
Immediate Feedback Advice to bedside nurse
Treatment if appropriate
VAT follow-up in 1-2 weeks
Personal interview (Nurse, supervisor, VAT leader)
Information Gathering for Analysis by VAT Improvement Team

39. Compare Is SO Important
EPIC Feedback Strategy Identified “Compare” Not Done Reliably

40. Compare Is SO Important
EPIC Feedback Strategy Identified “Compare” Not Done Reliably
PIV

41. “Compare” Not Done Reliably -Recent Change: Based On Interviews
So…. TLC Poster Revised
VOLUME (Pressure)
TOXICITY (Local Tissue)
Osmolality
pH (Acid – Base)
Biological Activity
Reliable Hourly Checks

42. The INS Grading System (Briefly)
Mostly Descriptive
Grades 1-4
Adult Based
Fixed Measurements regardless of Patient Size
Poor Harm Correlation with “Grades”
All Bad Outcomes were Grade 4 (Sensitive)
BUT….Very Few Grade 4’s had Bad Outcome (NOT Specific)
Combines TWO Separate Harm Components Into One “Grade”
VOLUME (“Edema”)
Medication TOXICITY
No official “Vesicant” list
Blood products included  Instant Grade 4

43. The INS Grading System (Briefly)
“Vesicant” Extravasation = Instant / Automatic Grade 4
1ml or 100 ml -
Same Grade, Very Different Outcomes
Grade 4

44. The INS Grade 4 Problem Assumption: Highest Grade = Highest Harm ??
2008
2009
CCHMC Safety Leaders Assumed “GRADE 4” =“Serious Harm”
“It’s the HIGHEST Grade.. Why not ??”
Grade 4 PIV “Harm” was >40% of “Total Hospital Harm”
Pressure on VAT to “Reduce Serious Harm” was Substantial

45. The CCHMC Extravasation Documentation Tool
It’s ONLY a Tool
Does NOT Change Outcomes Itself
Requires Leadership and Accountability
Informs Change and Quality Processes
Separates The Two Major Harm Components
Used for ALL Extravasations, Not Only PIV
Compulsory at CCHMC - INS Grades Not Available
EMR (EPIC) Very Helpful

46. CCHMC Extravasation Coding System
Step VOLUME Measurement
Step MEDICATION (If Any)
Step DOCUMENTATION

47. Step 1: VOLUME

48. Step 1a: VOLUME Measure Max Dimension Includes ANY Extravasation PIV
PICC
CVC
PORT
Scalp / Chest

49. Step 1b: VOLUME Measure ARM Length “Y” is ARM length
Surrogate for Patient Body Size
Easy To Measure
Allows Consistent Quantification
Even If Extravasation is Scalp, Leg or Chest
Never Measure Leg or Other Part for “Y”
No Arms?  CCHMC VAT Master Policy #1

50. Step 1b: VOLUME Measure ARM Length “Y” is ARM length
Surrogate for Patient Body Size
Easy To Measure
Allows Consistent Quantification
Even If Extravasation is Scalp, Leg or Chest
Never Measure Leg or Other Part for “Y”
No Arms?  CCHMC VAT Master Policy #1
CCHMC VAT Master Policy #1:
“Common sense and good judgment
will be used at all times”

51. Step 1c: Calculate

52. Step 1c: Calculate
An Extravasation can be > 100%

53. Step 2: MEDICATION

54. Step 3: DOCUMENT
Other Institutions

55. Step 3: DOCUMENT Other Institutions

56. Implementation BIG Education Effort CCHMC Education Team
Julie Stalf, RN
Sylvia Rineair, RN
Mary Haygood, RN
Barb Tofani, RN
CCHMC Education Team
Institution Wide Initiative

57. CCHMC System: Driving Treatment
In Plain English
TREAT
unless very good reason not to
Probably TREAT
unless good reason
not to
Probably NOT Treat unless good reason to do so
NO Treatment
Consult and TREAT

58. Result: Hyaluronidase Rx
$350
4-5 Needle Sticks
Previously Widely Recommended
75% DECREASED Use
No Serious Harm Events

59. CCHMC I/V Extravasation HARM
OUTCOME or
TREATMENT
Based

60. Results: Calendar 2012-13 Red Drugs ZERO Severe Harm
Moderate Harm = 0.55/1000 Line Days
Red Drugs
Most Red Drugs Now Only Given PIV in Code Situations
Even In A Code  Early Intraosseous Rx

61. Results: Calendar 2012-13 Red Drugs ZERO Severe Harm
Moderate Harm = 0.55/1000 Line Days
Red Drugs
Most Red Drugs Now Only Given PIV in Code Situations
Even In A Code  Early Intraosseous Rx
“No one has all the answers.
Severe Harm is only one slip up away” (2013)

62. Results: 2014 Red Drugs ZERO Severe Harm
Moderate Harm = 0.55/1000 Line Days
Red Drugs
Most PIV Red Drugs Now Only Given PIV in Code Situations  Early Intraosseous Rx
BUT:
Recent Case:
4.2% PIV Bicarbonate
“No one has all the answers.
Severe Harm is only one slip up away”

63. Documents Available:

64. Did We Change Anything? Probably ……… INS Grades 3-4 (2008 -2009)
No R Drugs
2014

65. Did We Change Anything? Probably ……… Only 1 Case of Serious PIV Harm
INS Grades ( )
INS Grades ( )
Probably ………
Only 1 Case of Serious PIV Harm
In 5 Years
No R Drugs
2014

66. “Still Working On It………..”
AVOID Unnecessary Risk
MINIMIZE Necessary Risk

67. Summary Overview: Our 4 Components
4 Year IV Extravasation Harm Reduction:
Most Effort is Culture Change / Leadership
Hard Work: MD / Nursing / Administration Silos are SOLID
Our 4 Components
Reliable Hourly Bedside PIV Checks
Evidence Based 3 Tier Medication Tissue Toxicity List
“No Grade” 2 Component Assessment / Documentation Tool
Real Cross-Cultural Leadership

68. Thanks iVAG (Our Governance Group)
The Whole Extraordinary CCHMC VAT Team
“rVAG”
Dallas Children’s Vascular Access Team
John Racadio MD
“Why Don’t You Just Abolish Grading ???”
Glen Minano – Graphics
Marshall Ashby Quality Improvement Consultant
Steve Muething MD
Vice President of Safety, CCHMC
Manuscript In Preparation:

69. Thanks What would we do for our own children ?
iVAG (Our Governance Group)
The Whole Extraordinary CCHMC VAT Team
Dallas Children’s Vascular Access Team
John Racadio MD
“Why Don’t You Just Abolish Grading ???”
Glen Minano – Graphics
Marshall Ashby Quality Improvement Consultant
Steve Muething MD
Vice President of Safety, CCHMC
What would we do for our own children ?

70. Preventing Pediatric Intravenous Extravasation Injuries
Questions – Discussion …….