Multiple IV Infusions: Research and Recommendations National Coalition for Infusion Therapy Safety Mar 12, 2015

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1 Multiple IV Infusions: Research and Recommendations National Coalition for Infusion Therapy Safety Mar 12, 2015 Mark Fan Sonia Pinkney Andrea Cassano-Piché

2 Overview Introduction Research findings and recommendations HumanEra Pennsylvania Patient Safety Authority Knowledge translation Guideline elearning modules

3 Introduction

4 Leaders in Healthcare Safety

5 ml ml/h

6 ml ml/h

7 ml ml/h ml ml/h ml ml/h ml ml/h ml ml/h ml ml/h ml ml/h 1000 ml 10 ml/h 1000 ml 10 ml/h ml ml/h ml ml/h

8 Courtesy of Pat Baird

9 Goals Identify risks with the administration of multiple IV infusions Identify and test interventions Recommend evidence-based interventions to minimize identified risks

10 Scope Excludes non-iv infusions (e.g., epidural, enteral, intrathecal etc.), and PCA infusions, unless they impact IV infusions Large volumetric IV infusion pumps (lab study and observations) and syringe pumps (observation only) All IV components (e.g., poles, tubing, connectors etc.) Focuses on bedside nursing environment; all IV medications are assumed to be correctly labelled and mixed

11 Management & Team Adapted from Vicente, 2004

12 Political & Professional Practice Education Interviews 13 program coordinators Organizational Expert Panel Management & Team Staff & Psychological Equipment & Surroundings Evidence Review Literature review 2 national incident databases Group Interviews 10 hospitals (managers, infusion specialists, nurses, pharmacists, doctors, risk management) Tech Scan 10 pump worklow analysis 5 interviews with vendors Field Study 12 hospital units in ON Survey 64 hospital units in ON Lab Study 40 ICU nurses from one Ontario hospital

13 Actual Environment

14 Our high fidelity simulation

15 insert Chris video(s) to ishow lab and scenario

16 Recommendations 1. Standardization of Practice (rules to support intention) Findings Expert Panel and OHTAC 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

17 Research Findings and Recommendations HumanEra

18 Five Themes 1. Setting up and programming multiple primary continuous IV infusions 2. Identifying an IV infusion 3. Managing shared infusion 4. Setting up a secondary intermittent IV infusion 5. Administering an IV pump bolus

19 1. Setting up and programming multiple primary continuous IV infusions

20 A B C Known set up risks New mix-up risks 50 ml/h 9 ml/h 100 ml/h A B C

21 Lab Study: Line Change Multiport Connector New Bridge 9% (11 of 120) infusions set-up (using traditional pump) as part of the line change task contained a error in programming the flow rate

22 Lab Study: Line Change Multiport Connector 45% (32 of 71) line changes include one or more unnecessary interruptions

23 Lab Study: Line Change Multiport Connector 45% (32 of 71) line changes include one or more unnecessary interruptions X X same as Infusion 1 same as Infusion 2 same as Infusion 3 same as Infusion 4

24 Lab Study Multiport Connector New Bridge Connecting the new bridge when full of sodium chloride 0.9% occurred in 18% of line changes

25 Date Labels Date labels not always applied to infusions Labelling methods differed what information should be communicated (e.g., date hung versus date of next line change) date format (e.g, 01/03 or 03/01)

26 Patient Transfers!

27 Patient Transfers!

28 Patient Transfers Respondents (%) 60% 50% 40% 30% 20% 10% 48.5% 33.3% 24.2% n = % 18.2% 18.2% 0% Pump must return to home unit Tubing/cnnctrs incompatible Drug library per care area Easier to move than reprogram Pump make and model differs Concentrations differ between units

29 Patient Transfers Respondents (%) 60% 50% 40% 30% 20% 10% 48.5% 33.3% 24.2% n = % 18.2% 18.2% 0% Pump must return to home unit Tubing/cnnctrs incompatible Drug library per care area Easier to move than reprogram Pump make and model differs Concentrations differ between units

30 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

31 Interventions 1.! Standardization of practice: Label primary IV tubing with pre-printed date change labels. Standardize the content, format of information and location of date labels

32 Interventions 1.! Standardization of practice: Label primary IV tubing with pre-printed date change labels. Standardize the content, format of information and location of date labels Ensure date change information is tracked consistently and reliably in all tracking systems Standardize medication concentrations (where possible), infusion pumps/channels and IV components between sending/receiving units and have pumps/channels follow and stay with patients

33 Five Themes 1. Setting up and programming multiple primary continuous IV infusions 2. Identifying an IV infusion 3. Managing shared infusion 4. Setting up a secondary intermittent IV infusion 5. Administering an IV pump bolus

34 2. Identifying an IV infusion

35 What s in this tubing? programming wrong pump connecting or disconnecting the wrong infusion injecting into the wrong IV line

36 Contributing Factors Visual complexity

37 Contributing Factors Visual complexity Poor organization

38 Contributing Factors Visual complexity Poor organization Obstructions to line tracing, such as gowns

39 Contributing Factors Non-standard infusion set-ups Lack of visual communication to clinicians along infusion pathway 30% (19 of 64) of respondents indicated there is no standard work practice regarding labelling of IV tubing 39% (17 of 44) of respondents do not label their emergency medication line and of those that do label, 93% (25 of 27) do not use a label that is visually distinct from other labels in the environment

40

41

42

43

44 Lab Study Evaluated 4 different conditions 1.Baseline (traditional pump) 2.Smart pump labels

45 Lab Study Evaluated 4 different conditions 1.Baseline (traditional pump) 2.Smart pump labels 3.Light identifier (traditional pump) ml ml/h 2 3

46 Lab Study Evaluated 4 different conditions 1.Baseline (traditional pump) 2.Smart pump labels 3.Light identifier (traditional pump) 4.Infusion organizers and preprinted labels (traditional pump)

47 1 1 IV rake pole top infusion organizers 2 Pre-printed IV tubing labels 3 IV tubing infusion organizers 2 3

48 Lab Study % Line Tracing Errors (out of 4) 9% 8% 7% 6% 5% 4% 3% 2% 1% 0% 7.7% 6.4% 3.2% 0.00 n = 39 participants x 4 tasks * p < 0.05 * Baseline Smart Pump Labels * Baseline Smart Pump Labels Light Linking System Pre-Printed Labels and Infusion Organizers

49 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

50 Recommendations 2.!Standardization of practice: Label primary IV tubing with the name of the infusate near the infusion pump and injection port on IV tubing closest to the patient -Use pre-printed labels to help standardize format of information Distinguish the IV push port for emergency use by using a visually prominent and distinct label When multiple IV access ports are used, indicated near the infusion pump the patient access port to which an infusion is connected

51 Recommendations 3.!Standardization of design: " Separate IV infusions and minimize tangles " Align the IV container to corresponding IV pump/channel " Use gowns with snaps, ties, or velcro on the shoulders!

52 Five Themes 1. Setting up and programming multiple primary continuous IV infusions 2. Identifying an IV infusion 3. Managing shared infusion volume 4. Setting up a secondary intermittent IV infusion 5. Administering an IV pump bolus

53 3. Managing shared infusion volume

54 Common volume shared by 2 or more infusates

55

56 1. Connected Infusions 2. Secondary IV Infusions 3. IV Push Doses 4. Change Concentration

57 accidental bolus a delay in therapy as the drug sits in the shared infusion volume drug incompatibilities 1. Connected Infusions 2. Secondary IV Infusions 3. IV Push Doses 4. Change Concentration

58 1. Minimize the amount of shared infusion volume

59 Literature and Field Study Minimize the size of the shared infusion volume in the design, acquisition, assembly and configuration of IV components connect IV infusions as close to patient as possible!

60 Literature and Field Study Minimize the size of the shared infusion volume in the design, acquisition, assembly and configuration of IV components connect IV infusions as close to patient as possible use connectors that minimize priming volume Peterfreund and Philips, Drug Deliv., (2013) 10(8)

61 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

62 Recommendations 4.!Standardization of practice: During the set up of infusions, reduce the amount of shared infusion volume by: Connecting IV infusions as close as possible to the patient access Using a multiport/lead connector when 3 or more IV infusions must be connected Refrain from chaining 3-way stopcocks in series to join infusions

63 Recommendations 5.!Standardization of design: The design of IV infusion systems (including all IV components) should minimize unnecessary priming/ shared infusion volume

64 2. Minimize the impact to a patient when a change is made to an IV infusion (e.g., increase in flow rate)

65 Central Venous Pressure (CVP) Monitoring Line Variation in shared infusion volume awareness and practices leading to potential hazards: Central venous pressure (CVP) line: 9 out of 17 (53%) respondents allowed continuous IV medications to be connected to the CVP line 13 out of 17 (76%) respondents allowed intermittent IV medications to be connected to the CVP line!

66 Lab Study - Manual IV Push 10 ml/h Shared Infusion Volume ~3.5 ml Furosemide Dose: 40 mg Vol: 4 cc

67 Lab Study - Manual IV Push 33% (13 of 40) did not flush 10 ml/h Shared Infusion Volume ~3.5 ml Furosemide Dose: 40 mg Vol: 4 cc

68 Lab Study - Manual IV Push 33% (13 of 40) did not flush 96% (24 of 25) flushed at wrong rate 10 ml/h Shared Infusion Volume ~3.5 ml Furosemide Dose: 40 mg Vol: 4 cc

69 Lab Study - Double Medication Concentration Norepinephrine Concentration: 8 mg/250 ml Norepinephrine Concentration: 16 mg/250 ml

70 Lab Study - Double Medication Concentration Norepinephrine Concentration: 16 mg/250 ml Norepinephrine Concentration: 8 mg/250 ml

71 Lab Study - Double Medication Concentration Norepinephrine Concentration: 8 mg/250 ml Norepinephrine Concentration: 16 mg/250 ml 100 ml/h

72 Lab Study - Double Medication Concentration Norepinephrine Concentration: 16 mg/250 ml Norepinephrine Concentration: 8 mg/250 ml Mismatch in concentration 50 ml/h 25% (10 of 40) re-used IV tubing and reprogrammed pump

73 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

74 Recommendations 4.!Standardization of practice: Minimize the shared infusion volume impact to a patient by: Avoiding connection of a continuous IV medication infusion to the central venous pressure (CVP) monitoring line may exclude fluid maintenance IVs such as ringer s lactate Avoiding using the transducer to flush the CVP line (or reading the CVP if using a manometer) when an intermittent IV medication (e.g., secondary IV infusion, IV push) is connected to the CVP line until the medication has cleared all IV tubing and connectors. Administering residual intermittent medication in the primary IV tubing after an IV bolus injection to ensure the complete dose is administered at the intended rate Using new IV tubing when initiating a new concentration of a continuous IV medication infusion

75 3. Clinicians must be educated regarding shared infusion volume

76 SIV Education Interviews with educators found that shared infusion volume concepts not explicitly or consistently taught in Ontario Baccalaureate nursing degree programs assumes covered in postgraduate specialized training and vice versa

77 Lab Study Evaluated 2 different conditions 1.Baseline 2.Education module!

78 Lab Study 1. Manual IV Push 35% 33% % Participant Not Flush 30% 25% 20% 15% 10% 5% * Baseline 13% 0% Baseline (Pre Education Module) Post Education Module n = 40 * p < 0.05

79 Lab Study 1. Manual IV Push 2. Double Medication Concentration 35% 33% 30% % Participant Not Flush 30% 25% 20% 15% 10% 5% * Baseline 13% % Participant Re-use Tubing 25% 20% 15% 10% 5% 25.0% 25.0% 0% 0% Baseline (Pre Education Module) Post Education Module Baseline (Pre Education Module) Post Education Module n = 40 * p < 0.05

80 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

81 Recommendations 6.!Standardization of education: IV infusion-related education (e.g., academic, in-service, annual re-certifications) should teach shared infusion volume fundamental principles and facilitate shared infusion volume management skill development. Include the following topics: Setting up and connecting multiple continuous infusions Administering an IV infusion via the central venous pressure monitoring line Changing the concentration of an IV infusion Administering an IV intermittent bolus injection Making a change (e.g., stop, titration, start) to an IV infusion connected to other infusions ## Completing a line change # Administering a secondary IV infusion

82 Five Themes 1. Setting up and programming multiple primary continuous IV infusions 2. Identifying an IV infusion 3. Managing shared infusion volume 4. Setting up a secondary intermittent IV infusion 5. Administering an IV pump bolus

83 4. Setting up a secondary intermittent IV infusion

84 1. Secondary infusion set-up demands high user vigilance

85 Secondary Infusion Errors Secondary infusion physical set-up errors are common Common setup errors are: 1.Pressure differential errors X Pressure Error Primary IV container Secondary IV container X Secondary Primary Rate

86 Secondary Infusion Errors Secondary infusion physical set-up errors are common Common setup errors are: 1.Pressure differential errors 2.Clamp on secondary IV tubing errors Most infusion pumps (traditional or smart pump) cannot detect and notify users if set-up is incorrect Primary IV container X Secondary IV container Secondary Clamp Error Secondary Primary Rate

87 Secondary Infusion Errors Observed secondary infusion set-up errors Reports of concurrent delivery of both primary and secondary IV bags (e.g., high flow rate in chemotherapy) Secondary infusion failure modes and principles of hydrostatic pressure not consistently taught in Ontario

88 Lab Study Evaluated performance in setting up a secondary infusion in 4 different conditions: 1.Baseline (traditional pump) 2.Smart pump with clamp detector 3.Education module (traditional pump)!

89 Lab Study Evaluated performance in setting up a secondary infusion in 4 different conditions: 1.Baseline (traditional pump) 2.Smart pump with clamp detector 3.Education module (traditional pump) X 4. Separate pump (traditional pump)

90 Lab Study Evaluated performance in setting up a secondary infusion in 4 different conditions: 1.Baseline (traditional pump) 2.Smart pump with clamp detector 3.Education module (traditional pump) 4. Separate pump (traditional pump) Tasks Normal secondary infusion A B

91 Lab Study Evaluated performance in setting up a secondary infusion in 4 different conditions: 1.Baseline (traditional pump) 2.Smart pump with clamp detector 3.Education module (traditional pump) x2 hooks 4. Separate pump (traditional pump) Tasks Normal secondary infusion Added precautions secondary infusion A B close clamp on primary IV tubing

92 Lab Study - Pressure Differential Errors % Pressure Differential Error 120% 100% 80% 60% 40% 20% 0% 35.0%!"#$%& 42.5% '((#(%& Clamp * detector 17.5% $(#(%& Baseline Clamp detector Education primary IV tubing had no module clamp above pump * Baseline Clamp detector * 0.0% (#(%& n = 40 * p < 0.05 )*+,-.& /01*23-+4& 53303& *29& Separate pump average written test score increased from 46% to 76%*

93 Lab Study - Pressure Differential Errors % Pressure Differential Error 120% 100% 80% 60% 40% 20% 0% 35.0%!"#$%& 42.5% '((#(%& Clamp * detector 17.5% $(#(%& Baseline Clamp detector Education module * Baseline Clamp detector * * Baseline Clamp detector * Education Module 0.0% (#(%& Separate pump n = 40 * p < 0.05 )*+,-.& /01*23-+4& 53303& *29&

94 Lab Study - Secondary Clamp Errors % Secondary Clamp Errors (out of 2) 30% 25% 20% 15% 10% 5% 0% 11.3% 25.0% IV tubing was re-used without fully flushing 33% (26 of 80) of instances when drugs incompatible 15.0% Education Module Education Module * * 0.0% Baseline Clamp detector Education module 0.0% Separate pump n = 40 participants x 2 tasks * p < 0.05 average written test score (clamp) 100% pre and post module

95 Lab Study - Connection Errors Not clear medication line (e.g., connected to other infusions) Across all conditions: 2.8% (9 of 320) of secondary infusions were attached to the wrong primary infusion (i.e., not clear line) 1.9% (6 of 320) of secondary infusions were attached to the right primary infusion but at the wrong port Secondary Rate

96

97 Lab Study - New Hazards with Separate Pumps ~6.5mL 78% of nurses failed to deliver the residual volume ~25mL

98 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

99 Interventions 7.!Standardization of practice: Set-up high-flow rate* and/or large-volume* secondary intermittent IV infusions using the appropriate set-up procedures defined by the infusion pump manufacturer *High flow rates and IV container size depends on manufacturer When administering a secondary IV intermittent medication, check compatibility with the previous secondary medication. If compatible, re-use the secondary IV tubing and back-prime from the primary IV bag

100 Interventions 8.!Standardization of design:!the design of IV infusion systems should: Eliminate the physical mechanistic set-up requirements to administer a secondary IV infusion; or Detect and alert users to set-up errors to facilitate interception and correction

101 Interventions 9.!Standardization of education: Education regarding secondary IV infusions (e.g., academic, infusion pump in-service, annual recertifications) should include: underlying IV infusion principles set-up risks best practices shared infusion volume

102 2. Minimize the impact to patients of administering the primary and secondary IV infusions at the wrong flow rate

103 Bag volume = 50 ml Bag volume = 250 ml Secondary ml/h ml Shared Infusion Volume = 25 ml

104 Bag volume = 250 ml Bag volume = 53mL Priming volume = 5 ml Overfill = 8 ml Secondary ml/h ml Shared Infusion Volume = 25 ml

105 Bag volume = 250 ml Bag volume = 28mL Priming volume = 5 ml Overfill = 8 ml Secondary ml/h ml Shared Infusion Volume = 25 ml

106 Bag volume = 250 ml Bag volume = 3mL Priming volume = 5 ml Overfill = 8 ml Primary ml/h ml Shared Infusion Volume = 25 ml

107 Bag volume = 250 ml Bag volume = 3mL Priming volume = 5 ml Overfill = 8 ml Primary ml/h ml Shared Infusion Volume = 25 ml 57% of the secondary infusate would have been administered at the programmed primary flow rate 9% of the primary infusate would have been administered at the secondary flow rate

108 Bag volume = 250 ml Bag volume = 3mL Priming volume = 5 ml Overfill = 8 ml Primary ml/h ml Shared Infusion Volume = 25 ml 57% of the secondary infusate would have been administered at the programmed primary flow rate 9% of the primary infusate would have been administered at the secondary flow rate 10% (25 of 240) of secondary infusions had a VTBI that was more than 10% of the IV container stated volume

109 Literature and Survey Secondary infusions should not be connected to highalert primary infusions* 31% (15 of 48) of survey respondents not always comply Continuous high-alert medications should only be administered as primary infusions (i.e., NOT secondary infusions) 29% (14 of 49) of survey respondents not always comply *Ref: ISMP Canada Safety Bulletin, February 2005, Secondary Infusions Require Primary Attention

110 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

111 Interventions 7.!Standardization of practice: Do not connect secondary IV infusions to high-alert primary continuous IV infusions Administer continuous high-alert medications only as primary IV infusions!identify a standard procedure for administering the complete secondary infusion dose at the intended rate for time and/or rate sensitive secondary medications. Considering the following: IV container overfill the amount of shared infusion volume/priming volume in the IV setup infusion pump programming workflow the tolerable flow rate variability for each medication

112 Five Themes 1. Setting up and programming multiple primary continuous IV infusions 2. Identifying an IV infusion 3. Managing shared infusion volume 4. Setting up a secondary intermittent IV infusion 5. Administering an IV pump bolus

113 5. Administering an IV pump bolus

114 100 Pump Based Bolus Errors Rate 10 Time A Incorrect bolus programmed 10 ml/h

115 100 Pump Based Bolus Errors Rate 10 Time A Incorrect bolus programmed 100 Rate 10 Time B Incorrect flow rate post bolus administration 10 ml/h

116 Lab Study Three conditions: 1.Baseline: Traditional pump (no bolus feature) 2.Traditional pump (bolus feature) 3.Smart pump (bolus feature) Primary Secondar Bolus!"#$%&'() *+,-%&' ml/h ml Rate Volume to be Infused 4 BOLUS DOSE DOSE DURATION _ mg _ min A midazolam (120 ml/h) Rapid Bolus [Conc]: 1 mg/ml 9 0. > enter DURATION Silence Ru Hold On Off Charge SETUP OPTIONS CONTI- NUOUS

117 Calculation: VTBI (ml) = 5 mg 200 mg 100 ml = 2.5 ml 2.5 Direct order input 5

118 Lab Study - Programming Errors % Bolus Programming Error Score (out of 2) 14% 12% 10% 8% 6% 4% 2% 0% 11.5% 10.3% * Baseline Traditional Bolus * 1.3% n = 39 participants * p < 0.05 Baseline (Traditional Pump) Traditional Pump with Bolus Feature Smart Pump with Bolus Feature

119 Lab Study - Bolus Flow Rate Average Bolus Flow Rate (ml/h) * Baseline Traditional Bolus * 152 n = 39 * p < Baseline (Traditional Pump) Traditional Pump with Bolus Feature Smart Pump with Bolus Feature 5-fold reduction in the bolus flow rate 59% used rapid bolus feature

120 Interventions 1. Standardization of Practice (rules to support intention) 2. Standardization of Design (devices to help ensure actions match intention) 3. Standardization of Education (knowledge to support intention in novel situations)

121 Interventions 10.! Standardization of design:! Administer an IV pump bolus using a smart pump bolus feature with the following risk reduction approaches: - Can only access bolus feature for medications that should be bolused with clinically appropriate soft and hard dose and rate/duration limits (defined by clinical area) - Can directly copy a prescriber s ordered bolus dose in drug specific units - Can program the bolus duration instead of flow rate. Option to autopopulate bolus duration from the drug library - Can communicate that a bolus infusion is being programmed and provides clear feedback regarding the bolus status (e.g., being administered, complete) Include hard upper rate limits for continuous IV infusions of high-alert medications (when possible)

122 In Sum

123 Practice Design Education

124 Courtesy of Pat Baird

125 Research Findings and Recommendations Pennsylvania Patient Safety Authority

126 Knowledge Translation

127 Research Practice

128 Research Practice

129 Knowledge Translation Research Practice

130 2 Tools

131 Guideline

132 Guideline Audience: Hospital management (CNO, Patient Safety, Unit managers)

133 Guideline Development Focus Groups HumanEra Draft Guidance x Pilot Projects RNAO Review & Integration (2015) Final Guideline (2016)

134

135 Interactive elearning Modules Audience: Front line nurses!

136 elearning Modules Interactive and engaging Underlying principles - vendor neutral - not knobology of pumps Make the invisible visible Re-emphasize best practices with memory aids Run-time: 20 min

137 Development Approach Design/Revise elearning Modules Usability Testing with ICU Nurses, post-graduate RN students & floor nurses 3 Rounds

138 Secondary IV Infusions

139 Secondary IV Infusions

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143 Secondary IV Infusions

144

145 Shared Infusion Volume 1.Administer an IV push dose 2.Change bag concentration 3.Administer drugs through the CVP monitoring line

146 Shared Infusion Volume 1.Administer an IV push dose 2.Change bag concentration 3.Administer drugs through the CVP monitoring line

147 Shared Infusion Volume

148

149

150

151 The Joint Commission, May 2014

152 The Joint Commission, May 2014

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