National, Cross-sectional, Multicenter Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil: a Quality Improvement Study (PIVS)
Conditions: Infusion Site Injury
Sponsor: Solventum US LLC

 
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Clinical Study Protocol 
 
 
Based on the International Conference on Harmonization 
Good Clinical Practice 
Consolidated Guideline 
Federal Register: Docket No. 95D-0219 
62 FR 25692/May 9, 1997  
 
 
Also Presented as 
Guidance for Industry 
E6 Good Clinical Practice: 
Consolidated Guidance 
 
U.S. Department of Health and Human Services 
Food and Drug Administration  
Center for Drug Evaluation and Research (CDER) 
Center for Biological Evaluation and Research (CBER) 
April 1996 
ICH 
 
 
 

 
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cc:   
Clinical Study Folder 
 
Investigator Study Documentation File (Regulatory Binder) 
 
 

 
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3M Study Number: EM-05-014222 
 
 
Protocol Title: National, cross-sectional, multicenter study to estimate the point prevalence of 
peripheral intravenous catheter-related complications in Brazil: a quality improvement study 
(PIVS) 
 
 
Investigator Agreement: I have read the protocol referenced above and I agree to conduct the 
study in accordance with the ethical principles that have their origin in the Declaration of 
Helsinki, Good Clinical Practice (GCP) and applicable state and federal regulations. 
 
 
Investigator Name:  
_______________________________________ 
 
 
Signature/Date:  
_______________________________________ 
 
 
 
Signature  
 
                                                 Date 
 

 
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Table of Contents  
 
1. 
BACKGROUND INFORMATION ......................................................................................................... 7 
1.1 Introduction ...................................................................................................................... 7 
1.2 Risk/Benefit Summary ..................................................................................................... 8 
1.3 Investigational Material Application ............................................................................... 8 
1.4 GCP and Regulatory Requirements ................................................................................. 9 
1.5 Study Population .............................................................................................................. 9 
2. 
STUDY OBJECTIVES AND PURPOSE .............................................................................................. 9 
2.1 Primary Objective ............................................................................................................ 9 
2.2 Secondary Objectives....................................................................................................... 9 
2.3 Exploratory Objectives .................................................................................................... 9 
3. 
STUDY DESIGN ................................................................................................................................... 9 
3.1 Study Type ....................................................................................................................... 9 
3.2 Study Setting .................................................................................................................. 10 
3.3 Study Procedures ........................................................................................................... 11 
3.4 Study Data Sources ........................................................................................................ 13 
3.4.1 
Study Variables ............................................................................................................. 13 
3.5 Randomization and Blinding ......................................................................................... 18 
3.6 Study Materials and Labeling ........................................................................................ 18 
3.7 Study Duration ............................................................................................................... 18 
3.8 Study Termination ......................................................................................................... 18 
3.9 Investigational Material Accountability ........................................................................ 19 
3.10 Protocol Modifications................................................................................................... 19 
3.10.1 
Protocol Amendments .............................................................................................. 19 
3.10.2 
Protocol Deviations .................................................................................................. 19 
3.11 Computerized Systems................................................................................................... 19 
4. 
SUBJECT SELECTION ...................................................................................................................... 20 
4.1 Subject Inclusion Criteria .............................................................................................. 20 
4.2 Subject Exclusion Criteria ............................................................................................. 20 
4.3 Subject Informed Consent.............................................................................................. 20 
4.3.1 
Confidentiality of study/subject data ............................................................................. 21 
5. 
ASSESSMENT OF SAFETY .............................................................................................................. 21 
5.1 Adverse Events Definitions ........................................................................................... 21 
5.2 Anticipated Device-Related Adverse Events ................................................................. 21 
5.3 Unanticipated/Serious Device Related Adverse Events: ............................................... 21 
5.4 Recording and Reporting Adverse Events ..................................................................... 22 
6. 
STATISTICS ....................................................................................................................................... 22 
6.1 Study endpoints .............................................................................................................. 22 
6.1.1 
Primary endpoint ........................................................................................................... 22 
6.1.2 
Secondary endpoints .................................................................................................... 22 
6.1.3 
Exploratory endpoints ................................................................................................... 22 

 
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6.2 Statistical Methods ......................................................................................................... 22 
6.2.1 
General aspects ............................................................................................................ 22 
6.2.2 
Primary endpoint analysis............................................................................................. 23 
6.2.3 
Secondary endpoint analyses ...................................................................................... 23 
6.2.4 
Exploratory endpoint analyses ..................................................................................... 23 
6.3 Sample Size Justification ............................................................................................... 24 
6.4 Procedures to Account for Missing, Unused, and Spurious Data .................................. 24 
6.5 Deviations to Statistical Plan ......................................................................................... 24 
7. 
MONITORING ..................................................................................................................................... 24 
8. 
QUALITY CONTROL AND QUALITY ASSURANCE ........................................................................ 24 
9. 
ETHICS ............................................................................................................................................... 25 
10. DATA HANDLING AND RECORD KEEPING ................................................................................... 25 
10.1 Study Personnel ............................................................................................................. 25 
10.2 Pre-Study Documentation Requirements ....................................................................... 25 
10.3 Completion and Return of Case Report Forms (CRFs) ................................................. 25 
10.4 Records, Reports and Retention Requirements ............................................................. 25 
11. REFERENCES ................................................................................................................................... 27 
12. APPENDICES ..................................................................................................................................... 28 
12.1 Appendix I– Definition of PIVC-related complications ................................................ 28 

 
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1. 
Background Information 
 
1.1 
Introduction 
Hospital personnel continually survey the infectious and mechanical complication rates 
related to short-term Central Venous Access Devices (CVADs). Routine reporting to hospital 
administration and/or government agencies has become mandatory in many countries, since 
these CVAD complications can significantly impact patient outcomes and healthcare costs. 
However, routine or mandatory surveillance (audits) of short peripheral IV catheter (PIVC) 
therapy does not occur in hospitals globally, despite the recognized impact of PIVC failure. 
PIVC failure is defined as any premature removal of an PIVC before the end of treatment, 
other than for routine replacement (includes phlebitis, infiltration, occlusion, accidental 
removal, leaking, dislodgement and local or catheter-related bloodstream infection2,12).  
 
PIVC therapy is beneficial to patients requiring medications or fluids that can be administered 
using peripheral veins and these catheters: (1) are used considerably more often than the 
CVADs, (2) have an overall failure rate that lies between 35% and 50%2, 3, 4, 5 and (3) can 
lead to bloodstream infections, which are less frequent than those associated with CVADs 
but are still serious complications6. Moreover, the rates of these and other complications that 
are known to contribute to PIVC failure, such as phlebitis and infiltration, are under-reported8. 
Understanding the impact of PIVC-related complications is paramount, given that PIVC 
failures can lead to delays in IV therapy, increased length of hospital stays and higher 
hospitalization costs7.  
 
According to Alexandrou et al. (2015)8, there are currently little data on PIVC management 
practices across different regions of the world, making it difficult to identify contributing factors 
for PIVC failure in general and for PIVC-related complications in particular. One of the main 
issues arising as a consequence of inadequate PIVC management practices is catheter 
dislodgment. Patients having securement-related issues, which might be associated with 
poor dressing and/or securement devices, are at greater risk for infection, thrombus formation 
and air embolism and are likely candidates for catheter replacement. 
 
Therefore, though evidence-based strategies have been developed to reduce PIVC-related 
complications, it is not known whether these strategies are consistently applied in the acute 
care setting6.  Audits and benchmarking of practice are necessary to drive improvement 
strategies and incite the development of interventional studies.  
 
A prevalence study is a quick method to audit and measure PIVC-related complications and 
compliance to evidence-based strategies. The Infusion Therapy Standards of Practice (2016) 
recommend regular evaluations of adverse events associated with PIVC use, such as 
infiltration, phlebitis, and/or bloodstream infection in populations of interest. Incidence studies, 
point prevalence studies and analyses of International Classification of Diseases (ICD) codes 
documented in electronic medical records are types of studies that can be used to meet this 
purpose. These regular evaluations must: (1) use consistent definitions; (2) compare current 
failure rates to internal historical data, to identify areas of improvement; and (3) result in data 
that are provided to the institution’s leadership. 
 
In this national, multicenter, cross-sectional study, healthcare professionals working in acute 
care hospitals, with expertise in PIVC therapy, will audit patient medical records and directly 
observe PIVC insertion sites on select hospital wards. The prevalence of PIVC-related 
complications that are identified upon observation will be determined. Furthermore, a 

 
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summary of PIVC management practices at each participating hospital or ward will be 
obtained. 
 
1.2 
Risk/Benefit Summary 
Risks to implementing this study are minimal. It is an observational study, centered on the 
study of PIVCs indwelling in adult patients admitted in acute care hospitals in Brazil, but not 
on the patients themselves.  
 
Products used in PIVC therapy have some benefit in maintaining the PIVC’s location and 
patency while the needed medical therapy is infused via the catheter. Yet, these benefits are 
sometimes overshadowed by several potential risks. The risks of implementing PIVC therapy 
include, but are not limited to: phlebitis, infiltration, extravasation, skin injury, ecchymosis or 
hematomas, local infection at the insertion site, catheter-related blood stream infections 
(CRBSI), catheter dislodgement, deep venous thrombosis, excessive blood loss from a 
disconnected infusion system, among others.10,11 
 
These risks or complications might be influenced by: (1) the adhesive and catheter stabilizing 
properties of the dressing cover and/or tape; (2) the ability of the nurse to visualize the site for 
early detection of complications; (3) the effectiveness and duration of the skin’s antimicrobial 
preparation; (4) the aseptic insertion technique and site location of the PIVC; (5) the design 
and gauge of the PIVC; (6) the medicinal or fluid therapy infused through the catheter; and 
(7) patient-related factors, e.g. gender, activity, skin condition, co-morbidities and history of 
previous PIVC complications. 4,7,10,11 
 
When products for PIVC therapy are effective, properly used and accompanied by good 
clinical practice, the benefits of PIVC therapy will significantly outweigh the risks identified 
above. The products that will be under observation during this study are all approved by the 
Brazilian regulatory agencies and are currently used at the hospitals for PIVC therapy. If the 
products are used as intended, the benefit obtained with the use of these medical devices 
should outweigh the risks associated with each one. 
 
It is expected that the prevalence study data will contribute to the site’s quality improvement 
program and help drive the nurses to: (1) evaluate and procure products to reduce 
complications; (2) develop and implement training programs on evidence-based strategies 
and (3) continue a surveillance practice to determine if new or modified interventions for PIVC 
management impact patient outcomes over time7. Furthermore, this study can provide a 
foundation for a wider point prevalence study of PIVC-related complications in Brazil and/or 
to design and implement further clinical studies of PIVC management. 
 
The Sponsor plans to use the data (de-identified) of this study for the pre-interventional 
phase of a pre-post interventional study. The data are to be compared to prevalence data 
obtained after the introduction of a dressing, which would comprise the post-interventional 
phase of the abovementioned pre-post interventional study. 
 
All necessary measures will be implemented to ensure the confidentiality of the research 
participants’ data. However, a minimal risk of data confidentiality breaches cannot be entirely 
ruled out. 
 
1.3 
Investigational Material Application  
No investigational materials will be provided or used in this prevalence study. All PIVC-
related products used at or on the PIVC insertion sites by the participating hospitals are 
approved by the Brazilian regulatory agencies, routinely purchased by the hospital and 
available to the physicians and nurses at the time of the study. Characteristics of the products 

 
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used at the PIVC insertion sites observed during the study will be documented. All PIVC 
brands will be observed in the context of this study. 
 
1.4 
GCP and Regulatory Requirements  
The whole conduction of the study will be performed in compliance with the protocol, the 
principles laid down on the Declaration of Helsinki, ICH’s Good Clinical Practice (GCP) and 
all applicable regulatory requirements. 
 
This research project was prepared in accordance with Resolution No. 466 of December 12, 
2012 of the National Health Council, which establishes the ethical standards for research 
involving human beings. Data collection will occur only after approval of the study and its 
documents by the Ethics Committee of each research center. 
 
1.5 
Study Population 
All persons with 18 or more years of age, admitted to the participating facility and who meet 
the eligibility criteria in Section 4. 
 
 
2. 
Study Objectives and Purpose 
 
2.1 
Primary Objective 
 
• 
To determine the prevalence of any PIVC-related complications, clinical or mechanical, in 
acute care hospitals in Brazil. 
 
2.2 
Secondary Objectives 
• 
To determine the prevalence of simultaneous clinical and mechanical PIVC-related 
complications in acute care hospitals in Brazil. 
• 
To determine the prevalence of PIVC-related clinical complications, overall and by type, in 
acute care hospitals in Brazil. 
• 
To determine the prevalence of PIVC-related mechanical complications, overall and by 
type, in acute care hospitals in Brazil. 
• 
To determine the prevalence of PIVC-related quality issues, overall and by type, in acute 
care hospitals in Brazil. 
• 
To describe the standards of practice for PIVC management employed in acute care 
hospitals in Brazil. 
 
2.3 
Exploratory Objectives 
• 
To explore the association between PIVC-related complications and subjects’ socio-
demographic characteristics, and other baseline characteristics.  
 
  
3. 
Study Design 
 
3.1 
Study Type 
This will be a national, multicenter, cross-sectional study to assess the prevalence of PIVC-
related complications in Brazil. Estimates of the prevalence of clinical and mechanical 
complications, as well as quality issues associated with PIVC management, will be studied. 
Moreover, hospital- or ward-specific standards of practice for PIVC management will be 
described. The study will be considered the pre-study stage of a pre-post interventional 
study. The de-identified data from this study will be used to calculate the effect of the 
intervention on the PIVC complication rate. 
  

 
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3.2 
Study Setting 
The study is expected to be conducted at three acute care centers located in Brazil. 
Assessment of PIVCs insertion sites and related complications, as well as of standards of 
practice for PVIC management, will take place at the hospitals’ general or specialty 
admission wards. Wards where the study procedures are not to be carried out include 
outpatient clinics, mental health wards, emergency wards and burn units.  

 
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All of the study team will receive training on the study protocol and other protocol-related 
procedures prior to study start. At each center, the study will only start after the study protocol 
and PIVC site assessment training is completed (Figure 1).  
 
Study procedures will be completed in a single center (pilot study site) prior to initiating study 
activities in the remaining centers. This strategy will allow for the adjustment of any training or 
monitoring needs identified at the first center. At each study site, including the pilot study site, 
study activities at the participating wards will be performed in parallel. The Principal 
Investigator (PI) will be responsible for selecting, at each site: 
• 
The wards that will be audited within the context of this study. 
• 
The healthcare professionals (auditors) that will be responsible for auditing the 
participating wards. Auditors will be healthcare professionals (e.g. nurse, resident 
physicians) with extensive experience in PIVC therapy and who are employed by the 
study site. 
 
Once the PI has selected the hospital’s wards that will be participating in the study, the PIVC 
Therapy Standards of Practice Questionnaire will be completed  by him/her or a designee. If 
there are individual PIVC therapy standards of practice per ward, rather than hospital-wide 
standards, the PI will interview the ward nurse manager or a ward clinician of the selected 
wards and complete the PIVC Therapy Standards of Practice Questionnaire for each ward.  
 
To minimize subject selection bias, all subjects will be identified and invited to participate in 
the study consecutively, as the auditor goes through the ward. An informed consent process 
will be carried out by the PI, auditor or a designee. After the subject provides his/her written 
informed consent to participate in the study , data will be collected from the subject’s medical 
records and by observation of the PIVC site. All PIVC sites, regardless of catheter 
commercial brand, should be assessed. Data on each PIVC site will be recorded on the 
Individual PIVC Questionnaire.  
 
In addition to collecting general characterization data on the patient and the PIVC, the auditor 
will be observing the PIVC site for presence of the following complications (see Appendix I for 
definitions): 
• 
Clinical complications:  
o 
Phlebitis: 
 
According to grade: grade 1-4 
 
According to etiology: mechanical, chemical, infective 
o 
Hematoma 
o 
Ecchymosis 
o 
Skin injury 
o 
Local infection 
• 
Mechanical complications: 
o 
Catheter dislodgement 
o 
Occlusion 
o 
Extravasation 
o 
Infiltration (grade 1-4) 
o 
Leaking at the insertion site 
 
The PIVC will also be evaluated for the presence of the following quality issues: 
• 
Unstable PIVC 
• 
Blood reflux 
• 
Uncontrolled IV infusion rate 
• 
Site dressing partially detached 
• 
Site dressing totally detached (site exposed to environment) 

 
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• 
Medical tape added to dressing edges 
• 
Unclean dressing 
• 
Discomfort at site with or without palpation 
• 
Uncovered tubing access port 
• 
Lack of visibility at the PIVC site 
 
If the patient has more than one PIVC, one questionnaire will be completed for each PIVC. 
 
Once the wards’ audits are concluded, the study-specific electronic case report forms 
(eCRFs) will be completed by the PI or study designee. The sponsor or sponsor’s 
representative will perform the monitoring activities and, based on the number or type of 
inconsistencies/ queries raised, the monitor may deem that the site requires additional 
training. Once the additional training is complete, the audit process will continue with any 
changes deemed necessary by the monitor to improve the quality and quantity of data 
collected. 
 
The process of PIVC-related data collection will be repeated at each study site until at least 
100 PIVCs have been audited (Table 1). 
 
 
Table 1 - Study data collection and procedures per audited ward 
 
Study proceduresa 
Pre-audit 
Audit day 
Completion of hospital’s or ward’s 
current PIVC Therapy Standards of 
Practice Questionnaireb 
 
X 
 
Inclusion and exclusion criteria review 
 
X 
Informed consent form signature 
 
X 
Completion of Individual PIVC 
Questionnaires 
 
X 
a. Procedures and timeline to be repeated if more than one ward is to be audited at the study site. 
b. Repeat survey of current PIVC standards of practice, if the standards are ward-specific. 
 
 
 
3.4 
Study Data Sources 
Information on the hospital’s or ward’s standards of practice for PIVC management will be 
recorded by the PI or designee into the Hospital/Ward PIVC Therapy Standards of Practice 
Questionnaire. 
 
After the subject provides his/her written informed consent, subject and PIVC-related data will 
be collected from the subject’s medical records and by observation of the PIVC insertion site. 
This information will be recorded into the Individual PIVC Questionnaire.  
 
The investigator will be responsible for ensuring that all the required data is collected in the 
study-specific eCRF. No subject identifiable information will be captured. 
 
3.4.1 
Study Variables 
The following variables will be collected in this study: 
• 
Hospital/Ward standards of practice for PIVC management: 
o 
Existence of standards of practice for PIVC management at the hospital or 
ward: yes/no 

 
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o 
Skin antiseptic solution used prior to PIVC insertion:  
 
Sterile or nonsterile normal saline 
 
Isopropyl alcohol (and percent alcohol concentration) 
 
Ethanol alcohol (and percent alcohol concentration) 
 
Povidone iodine (and percent concentration) 
 
Chlorhexidine gluconate (CHG) in alcohol (and percent CHG 
concentration) 
 
CHG alone 
 
Other (specify) 
 
Not defined 
 
o 
Skin antiseptic container: 
 
Multi-use bottle 
 
Single-use sterile container 
 
Not defined 
 
o 
Skin antiseptic solution applicator: 
 
Non-sterile gauze or absorbent pad 
 
Non-sterile cotton ball 
 
Sterile gauze or absorbent pad 
 
Sterile cotton ball 
 
Swab sticks 
 
Wipes or Wipettes 
 
Other (specify) 
 
Not defined 
 
o 
Frequency of PIVC site rotation: 
 
Every 72 hours 
 
Every 96 hours 
 
As clinically indicated 
 
Other (specify) 
 
Not defined 
 
o 
Frequency of PIVC assessment: 
 
Every 4 hours 
 
Every 8 hours 
 
Every 24 others 
 
Other (specify) 
 
Not defined 
 
o 
Method used to access or connect the catheter or primary IV tubing: 
 
Needle-based system 
 
Needleless-based system 
 
Access extension (side injector) 
 
3-way open female luer 
 
Not defined 
 
o 
Use of disinfectant cap to cover access ports, needleless caps or hubs when 
not in use or not connected to another IV set: yes, sometimes, no 
 
o 
Cap used to protect and seal the access ports or catheter hub when no 
infusion is administered:  

 
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 
Caps that accompany the IV tubing 
 
Needleless cap only 
 
Disinfection cap (Curos, SwabCap, other (specify)) 
 
Caps from a syringe needle 
 
No cap, end is directly connected to other tubing 
 
Access port not covered 
 
Not defined 
 
o 
Solution used to disinfect the access ports of the IV bag/bottle, catheter and 
tubing prior to attachment: 
 
70% isopropyl alcohol 
 
70% ethanol alcohol 
 
CHG solution (and percent CHG concentration) 
 
Other (specify) 
 
Not defined 
 
o 
Technique used to disinfect the access ports: 
 
Single swipe 
 
Twisting motion (timed or not) 
 
Back and forth motion with friction (timed or not) 
 
Other (specify) 
 
Not defined 
 
o 
Patients who receive infusion therapy through an infusion pump: 
 
All patients receiving IV medication, electrolyte or solution  
 
ICU patients only 
 
Limited to patients receiving specific medications 
 
None of the patients 
 
Other (specify) 
 
Not defined 
 
o 
Responsible person who adds medications and electrolytes to IV infusion 
bottles or bags: 
 
Nurse 
 
Pharmacist 
 
Physician 
 
Nurse technician 
 
Other (specify) 
 
Not defined 
 
o 
Environment where medications and electrolytes are added to IV infusion 
bottles or bags: 
 
Nurses’ station 
 
Medication room 
 
Patient’s room/ward 
 
Pharmacy 
 
Not defined 
 
• 
Socio-demographic variables: 
o 
Date of birth 
o 
Initials 
o 
Gender 
 

 
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• 
Individual PIVC variables: 
o 
Date and time of PIVC audit 
 
o 
Date and time of PIVC insertion 
 
o 
Responsibility for PIVC insertion: 
 
Nurse 
 
Physician 
 
Nurse technician 
 
Other (specify) 
 
Unknown/Not documented 
 
o 
Department where PIVC was inserted: 
 
Emergency department 
 
Operating room 
 
Intensive or Critical Care Unit (ICU) 
 
General ward/clinic 
 
Radiology or other procedure room 
 
Ambulance/Emergency Medical System (EMS) 
 
Other hospital 
 
Unknown/Not documented 
 
o 
PIVC location: 
 
Left or right hand 
 
Left or right wrist 
 
Left or right forearm 
 
Left or right antecubital fossa 
 
Left or right upper arm 
 
Left or right foot 
 
Left or right side of the head 
 
Other (specify) 
 
o 
Reason for PIVC insertion: 
 
IV fluids 
 
IV medications 
 
Blood sampling 
 
Patient unstable/requiring resuscitation 
 
Blood product transfusion 
 
Parenteral nutrition 
 
Chemotherapy 
 
Unknown/Not documented 
 
Other (specify) 
 
o 
Assessment of PIVC site is documented in the patient chart in the last 24 
hours: yes, no 
 
o 
Site labeled with date and time of catheter insertion: yes, no. 
 
o 
Site overdue for relocation: yes, no. If yes: description for absence of 
relocation in medical records (yes, no) 
 
o 
Use of PIVC: continuous, intermittent 
 

 
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o 
Flush solution used to keep the PIVC open: 
 
No flushing 
 
0.9% sodium chloride 
 
Heparin/heparinized saline solution 
 
Other (specify) 
 
Not applicable (PIVC used continuously) 
 
Unknown/Not documented 
 
o 
IV medications and solutions infused using this PIVC within the last 24 hours: 
 
Fluids without electrolytes 
 
Antimicrobials 
 
Analgesics 
 
Sedation 
 
Other (specify) 
 
None 
 
Unknown/Not documented 
 
o 
PIVC gauge/size: 
 
14G (orange) 
 
16G (grey) 
 
18G (green) 
 
20G (pink) 
 
22G (blue) 
 
24G (yellow) 
 
26G (purple) 
 
Steel needle 
 
Not visible 
 
Other (specify) 
 
o 
PIVC and administration set (extension tubing) securement 
 
Sutureless securement device 
 
Sterile tape strips around PIVC 
 
Non-sterile tape around PIVC 
 
Non-sterile tape over PIVC dressing 
 
Non-sterile tape around administration set 
 
IV administration set securement device 
 
Splint/bandage/tubular net 
 
Site dressing only 
 
Other (specify) 
 
o 
IV connectors: 
 
Extension tubing 
 
Stopcock/3-way tap 
 
Needleless connector directly attached to catheter hub 
 
Cap attached to the end of the catheter 
 
IV tubing directly connected to catheter 
 
Other (specify) 
 
None 
 
 
 
o 
PIVC dressing type: 
 
Tape only (type of tape: paper, plastic, soft cloth, silk, other (specify)) 

 
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 
Gauze and tape dressing 
 
IV FIX 
 
Transparent film dressing 
 
Transparent film dressing and tape 
 
Bordered film dressing 
 
No dressing 
 
Other (specify) 
 
o 
Signs and symptoms at the PIVC site: yes, no. If yes: 
 
Pain/tenderness on palpation 
 
Redness > 1 cm from insertion site 
 
Swelling > 1 cm from insertion site 
 
Purulence 
 
Itch/rash under dressing 
 
Blistering/skin tears under dressing 
 
Dried blood 
 
Palpable hard vein cord beyond IV tip 
 
Streak/red line along vein 
 
Induration/hardness of tissues > 1 cm 
 
Other (specify) 
 
o 
Presence of any of the following clinical complications: phlebitis (grade 1-4; 
mechanical, chemical, infective), hematoma, ecchymosis, skin injury, local 
infection. 
 
o 
Presence of any of the following mechanical complications: catheter 
dislodgement, occlusion, extravasation, infiltration (grade 1-4), leaking at the 
insertion site. 
 
o 
Presence of any of the following quality issues: unstable PVIC, blood reflux, 
uncontrolled IV infusion rate, site dressing partially detached, site dressing 
totally detached (site exposed to environment), medical tape added to 
dressing edges, unclean dressing, discomfort at site with or without 
palpation, uncovered tubing access port, lack of visibility at the PIVC site. 
 
3.5 
Randomization and Blinding 
 
No blinding will occur during the study.  As this is an observational study of existing PIVC 
practice and related complications, randomization is not applicable.  
  
3.6 
Study Materials and Labeling 
There are no study materials, except for the study-specific questionnaires.. 
 
3.7 
Study Duration 
The study is expected to be open at each participating site until a minimum of 100 PIVC sites 
are assessed, so that a minimum of 300 PIVCs are assessed at all three participating 
hospitals. 
 
Since this is an observational, cross-sectional study, each patient’s involvement in the study 
will have a duration of one day only. 
  
3.8 
Study Termination 
3M or the Investigator has the right to discontinue the study at any time for medical and/or 
administrative reasons.  As far as possible, this should occur after mutual consultation.   

 
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Conditions that may warrant termination of the study by 3M include, but are not limited to the 
following: 
• 
Failure of the Investigator to comply with pertinent ICH and ANVISA Regulatory 
Guidelines. 
• 
Insufficient adherence to protocol requirements. 
• 
Failure of the Investigator to complete the study at an acceptable rate. 
• 
Submission of knowingly false information from the Investigator to 3M. 
• 
Termination of Ethics Committee approval  
 
3.9 
Investigational Material Accountability 
 
Based on the study design and lack of intervention, no investigational material will be 
provided or used in this study. Only the study-specific questionnaires to document the 
required study information will be distributed to the investigators. The investigator must keep 
the completed investigational questionnaires in a secure storage area, accessible only to 
authorized individuals. 
 
3.10 Protocol Modifications 
 
3.10.1 Protocol Amendments 
The party initiating an amendment must confirm it clearly in writing using the 
Amendment/Administrative Revision form. It must be signed and dated by 3M and, in case of 
a significant amendment, the Investigator. A significant amendment means one that affects 
the safety, rights or welfare of subjects, the scope of the investigation or the scientific quality 
of the study. 
 
3M will forward any significant protocol amendments to each study site’s PI, who is 
responsible for submitting them to the Ethics Committee for approval. 
3.10.2 Protocol Deviations 
A deviation is a departure from the protocol that will likely affect the safety, rights or welfare of 
subjects, the scope of the investigation or the scientific quality of the study. 
 
If the study personnel fail to obtain the subject’s informed consent prior to data collection, 
then this would be considered a protocol deviation and the local Ethics Committee should be 
notified. 
  
Deviations that potentially affect data integrity or compromise the statistical analysis of the 
study require immediate communication to 3M. The Investigator must contact the 3M study 
monitor within 24 hours of occurrence. A Protocol Deviation Form must be completed by the 
Investigator and include the type of deviation and a description of the circumstances 
surrounding the deviation. A copy is sent to the 3M study monitor within 24 hours of 
identifying the occurrence. This kind of deviation should also be notified to the local Ethics 
Committee. 
 
 
 
3.11 Computerized Systems 
 
Computerized systems that will be used to create, modify, maintain, archive, retrieve or 
transmit data include, but may not be limited to: 
• 
SAS 

 
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• 
Excel 
• 
Word 
• 
Microsoft Outlook 
 
 
4. 
Subject Selection 
The study population will include adult patients admitted to the wards of the participating acute care 
hospitals that will be audited in the study. To minimize subject selection bias, all subjects will be 
identified and invited to participate in the study consecutively, as the auditor screens the ward on 
the day of the audit. 
  
To be included in the study and for their PIVC sites to be evaluated, each patient should meet all of 
the inclusion criteria and none of the exclusion criteria described in the sections below. Subjects 
should provide written informed consent prior to any study-specific observations and data 
collection. 
 
4.1 
Subject Inclusion Criteria 
Subjects must fulfil all the following inclusion criteria at the time of the audit to be included: 
• 
Male or female subject, aged 18 years or older at the time of the study’s audit of the ward; 
• 
Subject admitted into one of the wards audited at the study site; 
• 
Subject available for observation at the time of the audit; 
• 
Subject with at least one inserted PIVC; 
• 
Subject that voluntarily signed and dated the informed consent form (ICF) prior to study 
entry. 
 
4.2 
Subject Exclusion Criteria 
Subjects must not meet any of the following exclusion criteria at the time of the audit to be 
included:  
 
• 
Subject under treatment at the study site’s outpatient clinics; 
• 
Subject admitted into a mental health ward, emergency ward or burn unit; 
• 
Subject awaiting transfer to another facility. 
 
4.3 
Subject Informed Consent  
 
The Investigator at each site must obtain a written informed consent of all subjects to 
participate in the study, before study-related procedures. Full and adequate information about 
the nature, purpose, possible risks and benefits of the study must be provided. Subjects must 
also be notified that they are free to discontinue their participation in the study at any time. The 
subjects should be given the opportunity to ask questions and allowed time to consider the 
information provided. 
 
As delineated in ResolutionNo466 and PANDRH-GCPs , the ICF content should be briefly and 
clearly presented orally, and in writing, in a manner that is easy to understand, commensurate 
with the comprehension level of the research participants, and without coercion or unduly 
influencing a potential participant to enroll in the study. Specifically, the Investigator is to 
explain to each subject all elements of informed consent as specified in ANVISA Regulatory 
Guidelines. 
 
After the explanation, the subject or representative will voluntarily sign and date the consent 
form if they wish to participate in the study. An original version of the consent form must be 
provided to the subject. Another original signed and dated version of the ICF must be 

 
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maintained in the Investigator study documentation file at all times. The process of consent 
and study participation, with date, must be documented in the patient record/chart. 
 
4.3.1 
Confidentiality of study/subject data 
 
The Subject ICF will incorporate wording that complies with relevant data protection and 
privacy legislation. Pursuant to this wording, subjects will authorize the collection, use and 
disclosure of their personal data by the Investigator and by those persons who need that 
information for the purposes of the study. 
 
The Subject ICF will explain that study data will be stored in a computer database, 
maintaining confidentiality in accordance with the local law for Data Protection. The subject 
should be informed that all data will be anonymized and grouped for analysis, making it 
impossible to identify unique patient data. 
 
The Subject ICF will also explain that, for quality check purposes, a monitor of 3M or 
designee, will require direct access to the signed subject ICFs and to the source documents 
that are part of the hospital or practice records relevant to the study. 
 
 
5. 
Assessment of Safety 
 
5.1 
Adverse Events Definitions 
An adverse event is any undesirable clinical occurrence, whether it is considered to be 
device- or drug-related or not.  
 
5.2 
Anticipated Device-Related Adverse Events 
This an observational, cross-sectional study that is not designed to identify or quantify a 
safety hazard relating to an authorized medicinal product or medical device. Nevertheless, 
there are anticipated device-related adverse events that may occur during this study and are 
related to the current practice of PIVC therapy at the study sites. According to IV 
professionals and IV-related literature, the anticipated device-related adverse events that 
may occur are:  
1. 
Certain skin reactions, such as mild to moderate redness, blisters, itching, and/or minor 
skin denudations at the site of the adhesive which should dissipate within one to seven 
days after removal; 
2. 
Loss of the PIVC from the insertion site;  
3. 
Leaking of fluid or blood from PIVC insertion site; 
4. 
Phlebitis and/or;  
5. 
Infiltration of an infusate. 
 
5.3 
Unanticipated/Serious Device Related Adverse Events: 
The following list of unanticipated and/or more serious device-related adverse events are 
unlikely to be identified during this study, unless the audit nurse reads of the event during the 
medical record review. Excluding the severe skin reactions, the nurse auditors will most likely 
not be aware of the following unanticipated and/or serious adverse events:  
1.  Any catheter-related phlebitis with a fever; 
2.  A catheter-related phlebitis or infiltration that extends hospitalization; 
3.  A catheter-related blood stream infection (PIV-CRBSI); 
4.  Severe skin stripping or skin reaction; or 
5.  Extravasation. 
 

 
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5.4 
Recording and Reporting Adverse Events 
PIVC-related adverse events can occur at any time during the conduct of the study and may 
be identified by the Investigator (or designee), auditor or patient. The auditor who observes a 
PIVC-related adverse event or is told of an adverse event by the patient is responsible for 
reporting the event to the nurse caring for the patient. The patient’s nurse and/or physician 
will be responsible for treating the patient. The country’s and/or hospital’s formal adverse 
event (incident) reporting process will be used to document the adverse event.  
 
If the PIVC-related adverse event is also a PIVC-related complication of interest for the study 
(Section 3.3), their presence will be documented by study personnel in the corresponding 
Individual PIVC Questionnaire. There is no requirement for any additional information on 
adverse events to be recorded in the eCRF. Further details on adverse events that are also 
complications of interest for the study will be processed in accordance with the 
abovementioned country’s or hospital’s formal adverse event (incident) reporting process.  
 
 
6. 
Statistics 
 
6.1 
Study endpoints 
 
6.1.1 
Primary endpoint 
• 
Proportion of PIVCs sites with at least one clinical or mechanical complication. 
 
6.1.2 
Secondary endpoints 
• 
Proportion of PIVC sites with at least one clinical and one mechanical complication. 
• 
Proportion of PIVC sites with at least one clinical complication and with each specific clinical 
complication. 
• 
Proportion of PIVC sites with at least one mechanical complication and with each specific 
mechanical complication. 
• 
Proportion of PIVC sites with at least one related quality issue and with each specific quality 
issue. 
• 
Frequency distribution for the PIVC Standards of Practice. 
 
6.1.3 
Exploratory endpoints 
Measures of association between PIVC-related complications and sociodemographic 
characteristics, as well as between PVIC-related complications and other baseline 
characteristics will be examined, if appropriate.  
 
6.2 
Statistical Methods 
 
6.2.1 
General aspects 
For the purposes of the present study, the unit of analysis will be the individual PIVC sites 
and not the patients in which they are inserted. 
 
Descriptive statistics will be obtained for numerical variables, including central tendency 
measures such as mean, median as well as the dispersion measures of standard deviation, 
min-max and inter-quartile range. Descriptive statistics for categorical variables will include 
frequencies’ tabulation with counts and percentages. No imputation of missing values will be 
made. 95% confidence intervals will be used if applicable. The significance tests of 
association under exploratory analyses will be made at the 5% significance level. 
 
Data will be presented for the overall study sample, as well by hospital and by hospital ward. 
 

 
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6.2.2 
Primary endpoint analysis 
The prevalence of PIVC-related complications among the PIVC sites audited at the 
participating acute care hospitals in Brazil will be determined as follows: 
 
• 
Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical 
complication ÷ Number of audited PIVC sites) x 100 
 
The definitions of clinical and mechanical complications are detailed in Section 3.3 and 
Appendix I. 
 
6.2.3 
Secondary endpoint analyses 
 
• 
The prevalence of PIVC-related clinical and mechanical complications among the PIVC 
sites audited at the participating acute care hospitals in Brazil will be determined as 
follows: 
→ Prevalence (%) = (Number of audited PIVC sites with at least one clinical and 
one mechanical complication ÷ Number of audited PIVC sites) x 100 
 
• 
The prevalence of PIVC-related clinical complications among the PIVC sites audited at 
the participating acute care hospitals in Brazil will be determined as follows: 
→ Prevalence (%) = (Number of audited PIVC sites with at least one clinical 
complication ÷ Number of audited PIVC sites) x 100 
→ Prevalence (%) = (Number of audited PIVC sites with each specific clinical 
complication ÷ Number of audited PIVC sites) x 100 
 
• 
The prevalence of PIVC-related mechanical complications among the PIVC sites audited 
at the participating acute care hospitals in Brazil will be determined as follows: 
→ Prevalence (%) = (Number of audited PIVC sites with at least one mechanical 
complication ÷ Number of audited PIVC sites) x 100 
→ Prevalence (%) = (Number of audited PIVC sites with each specific mechanical 
complication ÷ Number of audited PIVC sites) x 100 
 
• 
The prevalence of PIVC-related quality issues among the PIVC sites audited at the 
participating acute care hospitals in Brazil will be determined as follows: 
→ Prevalence (%) = (Number of audited PIVC sites with at least one quality 
issue÷ Number of audited PIVC sites) x 100 
→ Prevalence (%) = (Number of audited PIVC sites with each specific quality issue 
÷ Number of audited PIVC sites) x 100 
 
 
The definitions of clinical and mechanical complications, as well as of quality issues, are 
detailed in Section 3.3 and Appendix I.  
 
PIVC Standards of Practice will be summarized using descriptive statistics. 
 
6.2.4 
Exploratory endpoint analyses 
Exploratory analyses will be performed with the aim of identifying the subject- and PIVC 
characteristics associated with the occurrence of PIVC-related complications. 
 

 
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The association of qualitative variables with the occurrence of PIVC-related complications will 
be performed with the chi-squared test or with the Fisher’s test, while the association of 
quantitative variables with the occurrence of PIVC-related complications will be performed 
with the student’s t test or the Mann-Whitney test. 
 
Generalized estimating equation (GEEs) models will be used to identify the most important 
patient characteristics associated with the multivariate binary occurrence of PIVC-related 
complications, with a Logit link function and considering the correlation structure assumed as 
exchangeable within patients. The Odds Ratios as well as 95% confidence intervals will be 
estimated. The significance level will be established at 5%. 
 
 
6.3 
Sample Size Justification 
No formal sample size calculation has been performed. Based on expert knowledge, it is 
assumed that a minimum of 100 PIVCs audited per hospital (or a total of 300 PIVCs 
audited in the study) will provide an adequate estimate of the prevalence of PIVC-related 
complications. In case a site experiences difficulty in meeting the expected recruitment 
rate, other participating sites may be proposed to include an additional number of 
patients, until the total is achieved. 
 
6.4 
Procedures to Account for Missing, Unused, and Spurious Data  
Investigation of spurious and/or missing data will be discussed in the final report. 
Imputation of missing data will not be performed. Non-use of data will be described and 
justified in the final report. 
 
6.5 
Deviations to Statistical Plan 
Any deviation(s) from the original statistical plan should be described and justified in the 
in the final report, as appropriate. 
  
 
7. 
 Monitoring 
3M, as sponsor of this study, is responsible for ensuring the proper conduct of the study regarding 
adherence to the protocol, as well as to the applicable legislation and regulation, and the validity of 
the data recorded on the eCRFs. Monitoring activities will be performed at the study sites by: 
 
• 
Periodic on-site review 
• 
Telephone communications  
• 
Review of eCRFs and source documents (e.g. patient hospital records, clinical charts,  
doctor’s notes, Informed Consent Form, etc.) 
 
The Investigator will give the 3M and the CRO study monitor direct access to source documents 
that support data on the eCRFs and make available such records to authorized 3M personnel, 
Quality Assurance personnel, Ethics Committee, and regulatory personnel for inspection. 
 
 
 
 
8. 
Quality Control and Quality Assurance 

 
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3M is responsible for implementing and maintaining quality assurance and quality control systems 
through written standard operating procedures (SOPs) to ensure that this study is conducted, and 
data are generated, documented and reported in compliance with the protocol, GCP and 
regulations cited in Section 1.5 of this protocol. Study monitoring will be carried out to accomplish 
this.   
 
 
9. 
Ethics 
The study will be conducted in compliance with the protocol, the foundational principles on the 
Declaration of Helsinki, ICH’s GCP and all applicable regulatory requirements. 
 
This research project was prepared in accordance with Resolution No. 466 of December 12, 2012 
of the National Health Council, which establishes the ethical standards for research involving 
human beings. The study will start only after approval of the protocol and of the ICF by the Ethics 
Committee and after the Research Agreement has been established with the site. 
 
3M must receive a copy of the Ethics Committee approval letter prior to study initiation.  
  
 
10. 
Data Handling and Record Keeping 
 
10.1 
Study Personnel 
Prior to study initiation, the Investigator must provide 3M with a signed investigator agreement 
(Statement of Investigator).  The agreement contains pertinent investigator information (e.g. 
qualifications, experience, etc.) as well as the Investigator’s commitment to conduct the study 
according to the protocol and all applicable state and federal regulations. 
 
10.2 
Pre-Study Documentation Requirements  
Prior to study initiation, the Investigator must provide 3M with the following documents: 
• 
Signed protocol including any amendments in place prior to study initiation; 
• 
Curriculum vitae for all study staff; 
• 
Ethics Committee study approval letter;  
• 
Ethics Committee approved consent form; 
• 
Ethics Committee name, location and chairperson; 
• 
Signed research agreement.  
 
10.3 
Completion and Return of Case Report Forms (CRFs) 
The Investigator will review all eCRFs for completeness and accuracy. If a correction is required, a 
single line must be drawn through the error. The person making the correction will initial, date, and 
provide a reason for the error (if not self-evident). 
 
The Investigator must attest to the quality, accuracy and completeness of all eCRFs in a timely 
fashion. The monitor will review the eCRFs to assure accuracy and completeness. Any data 
queries prepared after the eCRFs have been completed must be answered promptly. 
 
 
10.4 
Records, Reports and Retention Requirements 
The Investigator will maintain study records for a minimum of 5 years following completion of the 
study. Records that must be maintained by the Investigator include, but are not restricted to: 
 
● 
Signed study protocol, amendments and protocol deviations; 
● 
Ethics Committee approval of protocol, ICF and amendments to any of these 
documents;  

 
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● 
Applications to the Ethics Committee; 
● 
Signed ICFs; 
● 
Study-specific questionnaires; 
● 
Correspondence relating to the study; 
● 
Sponsor Final Report. 
 
 
 
 
 

 
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11. References 
1. PR Newswire. Global Peripheral I.V. catheter market 2014-2018. 
2. Rickard CM, Webster J, Allis MC. Routine versus clinically indicated replacement of 
peripheral intravenous catheters: a randomized controlled equivalence trial. Lancet. 2012; 
380 (9847): 1066-1074 
3. Webster J, Clarke S, Peterson D, et al. Routine care of peripheral intravenous catheters 
versus clinically indicated replacement randomized controlled trial. BMJ. 2008; 337: 1-6. 
4. Bausone-Gazda D, Lefavier CA, Walters SA. A randomized controlled trial to compare the 
complications of 2 peripheral intravenous stabilization systems. J Infus Nurs. 2010; 33 (6): 
371-384. 
5. Martinez JA, Piazuelo M, Almela M, et al. Evaluation of add-on devices for the prevention 
of phlebitis and other complications associated with the use of peripheral catheters in 
hospitalized adults: a randomized controlled study. J Hosp Infect. 2009; 73 (2): 135-142. 
6. Maki DG. Improving the safety of peripheral intravenous catheters. BMJ 2008; 337: 122-
23. 
7. Wallis MC, McGrail MR, Webster J et al. Risk factors for PIV catheter failure: a multivariate 
analysis from a randomized control trial. Infect Control Hosp Epidemiol 2014; 35 (1): 63-
68. 
8. Alexandrou E, Ray-Barruel G, et al. International Prevalence of the Use of Peripheral 
Intravenous Catheters. Journal of Hospital Medicine 2015; 00(00): 1-4. 
9. Gorski L, Hadaway L, et al. Infusion Therapy Standards of Practice. Journal of Infusion 
Nursing 2016; 39 (1S). 
10. Mattox, E. Complications of Peripheral Venous Access Devices: Prevention, Detection, and    
Recovery Strategies CriticalCareNurse 2017; 37(2): e1-e14. 
11. Helm, R et al. Accepted but Unacceptable: Peripheral IV Catheter Failure. Journal of 
Infusion Nursing, 38(3), 189-203. 
12. Marsh, N et al. Securement methods for peripheral venous catheters to prevent failure: a 
randomized controlled pilot study. JVasc Access 2015; 00(00): 1-8. 

 
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12. Appendices 
 
 
12.1 
Appendix I– Definition of PIVC-related complications 
 
Table A – Definition of clinical PIVC-related complications 
 
Complication 
Definition 
Phlebitis 
Presence of pain, tenderness, warmth, erythema or streak 
formation at or near the PIV insertion site due to movement, 
chemical irritant and/or bacteria. Thus, according to etiology, 
phlebitis may be classified as: 
• 
Mechanical: If the catheter is dislodged or not secure (i.e., 
moves) 
• 
Chemical: If the patient is receiving, KCI, IV fluids or 
antibiotics that tend to cause phlebitis 
• 
Infective: if local infection is also present 
The degree of phlebitis is rated using a scale ranging from 1 to 4a: 
• 
Grade 1: Erythema at access site with or without pain. 
• 
Grade 2: Pain at access site with erythema and/or edema. 
• 
Grade 3: Pain at access site with erythema, streak 
formation, and/or palpable venous cord. 
• 
Grade 4: Pain at access site with erythema, streak 
formation, palpable venous cord >1 inch in length, and/or 
purulent drainage. 
Hematoma 
A localized swelling that is filled with blood caused by a break in 
the wall of a blood vessel. 
Ecchymosis 
Similar to a hematoma. A subcutaneous spot of bleeding (from 
extravasation of blood) with diameter larger than 1 centimeter. 
Skin injury 
Superficial damage to the skin as seen by redness, tears, or 
erosion of the skin, or development of blisters in an area exposed 
to medical adhesive and lasting for 30 minutes or more. 
Local infection 
Redness and/or induration within 2 cm of exit site with or without 
purulent drainage. 
a. From: Alexander M. Corrigan A. Infusion Nurses Society:  Infusion nursing an evidence-based approach.  St. 
Louis, Mo.: Saunders-Elsevier; 2010.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table B – Definition of mechanical PIVC-related complications 

 
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Complication 
Definition 
Catheter dislodgement 
Movement of the PIV catheter out of the insertion site to the point it 
cannot be safely used, excluding infiltration. 
Occlusion 
Stopping or slowing of I.V. fluid flowing from the I.V. bag into the 
bloodstream. Signs: one is unable to easily flush fluid into the 
catheter without resistance. Causes: blood clotting in the catheter, 
kinking of the catheter or tubing, an admixture of medications/fluids 
or a venous thrombosis. 
Extravasation 
Accidental infiltration of a vesicant or chemotherapeutic drug into 
the tissues surrounding the IV site resulting in edema and/or tissue 
necrosis. 
Infiltration 
When a solution or medication enters the surrounding tissues due 
to catheter dislodgement or vein ruptures. Recognized by 
increasing edema at or near the venipuncture site. The degree of 
infiltration is rated using a scale ranging from 1 to 4: 
• 
Grade 1: Skin blanched; edema <1 inch in any direction; 
cool to touch; with or without pain. 
• 
Grade 2: Skin blanched; edema 1-6 inches in any 
direction; cool to touch; with or without pain 
• 
Grade 3: Skin blanched, translucent; gross edema>6 
inches in any direction; cool to touch; mild-moderate pain; 
possible numbness. 
• 
Grade 4: Skin blanched, translucent; skin tight, leaking; 
skin discolored, bruised, swollen; gross edema>6 inches in 
any direction; deep pitting tissue edema: circulatory 
impairment; moderate-severe pain; infiltration of any 
amount of blood product, irritant, or vesicant. 
Leaking at the infusion site 
IV fluid found under the dressing that is exiting the catheter 
insertion site. 
a. From: Alexander M. Corrigan A. Infusion Nurses Society:  Infusion nursing an evidence-based approach.  St. 
Louis, Mo.: Saunders-Elsevier; 2010. 

 
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3M Center 
 
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Status:  Release  
Version: 3 
Issue Date: 10/22/2018 07:47:30 PM CDT   
 
3M Confidential 
Document Name: CLIN-PROT-ICH-US-05-331782 
Clinical and Non-Clinical: CLIN-INDEX-3M-SPON-US-05-014222 
 
Table C – Definition of PIVC-related Quality issues 
 
Issue 
Definition 
Unstable PIVC 
Catheter moves when touched or when patient moves 
yet is still functioning. 
Blood reflux 
Blood observed in the tubing, not associated with a 
recent blood infusion. 
Uncontrolled IV infusion rate 
Infusion rate controlled by only a roller clamp or by 
gravity. 
Site dressing partially detached 
Dressing is lifted off skin, but insertion site not exposed 
to environment (25% or greater) 
Site dressing totally detached 
Dressing is lifted off skin and insertion site exposed to 
environment 
Medical tape added to dressing 
edges 
Tape added to the edges of the insertion site cover or 
dressing to prevent the dressing from lifting up off the 
skin either due to the presence of edge lift or to prevent 
lift from occurring. 
Unclean dressing 
Stains or dirt observed on the dressing due to blood, 
food, secretions and/or other outside contaminants  
Discomfort at the site with or 
without palpation 
When subject states that the catheter is painful or 
uncomfortable, if asked, OR when subject complains of 
pain when the catheter insertion site is touched 
(palpated). 
Uncovered tubing access port 
An access port that is open to the environment without a 
cover or cap 
Lack of visibility 
When the auditor cannot see the catheter insertion site 
due to (1) the opacity of the dressing, e.g. tape dressing 
or (2) tape, gauze pad or patch used under a film 
dressing.