Family Practice, 2016, Vol. 33, No.

4, 432–438
doi:10.1093/fampra/cmw026
Advance Access publication 3 May 2016

Research Methods

Vaccination errors in general practice: creation

of a preventive checklist based on a multimodal
analysis of declared errors
Rodolphe Charlesa,*, Josette Valléea, Claire Tissota, Frédéric Luchtb and

Downloaded from http://fampra.oxfordjournals.org/ at University of Melbourne on August 25, 2016

Elisabeth Botelho-Neversb
a
Department of General Practice, Jean Monnet University, COMUE University of Lyon, Medical College, Pôle Santé
Nord, 10 rue de la Marandière, BP80019, 42270 Saint Priest en Jarez and bClinical Investigation Center (CIC)1408
Reivac, Hospital University of Saint-Etienne, Avenue Albert Raimond, 42055 Saint Etienne Cedex 02, France.

*Correspondence to Rodolphe Charles, Department of General Practice, Jean Monnet University, COMUE University of
Lyon, Medical College, Pôle Santé Nord, 10 rue de la Marandière, BP80019, 42270 Saint Priest en Jarez, France; E-mail:
rodolphe.charles@univ-st-etienne.fr

Abstract
Background.  Vaccination is a common act in general practice in which, as in all procedures in
medicine, errors may occur. To our best knowledge, in this area, few tools exist to prevent them.
Objective.  To create a checklist that could be used in general practice in order to avoid the main errors.
Methods.  From April to July 2013, we systematically searched for vaccination errors using three
sources: a review of literature, individual interviews with 25 health care workers and supervised peer
review groups meeting at the Medicine school of Saint-Etienne (France). The errors most frequently
retrieved were used to create the checklist that was regularly submitted to interviewed caregivers to
improve its construction and content; its stabilization has been conceived as an evidence of finalization.
Results.  The checklist’s draw-up included three parts allowing verification at each stage of the
vaccination process: before, during and after the vaccine administration. Before the vaccination,
items to be checked were mainly does my patient need and may he/she receive this vaccine in
accordance with the national French vaccination guidelines? During the preparation and the
administration of vaccination, items to be checked were are the patient and the practitioner
comfortable? Is all the material needed correctly prepared? Is the appropriate route defined?
Ultimately, after the vaccination, most items to be checked concerned traceability. This checklist
seemed useful and usable by the panel of practitioners questioned.
Conclusion.  This vaccination checklist may be useful to prevent errors. Its efficacy and feasibility
in clinical practice will require further testing.

Key words. Immunization, medical errors/patient safety, physician competency, practice management, primary care.

Introduction errors may increase the defiance of general population face to vaccina-
tions. Preventing them is therefore needed to reassure patients.
In France, vaccination is a common act in general practice (1). According
Medical errors result from a discrepancy between action and
to a survey including 922 French GPs, vaccination is the 19th most com-
intent in a given context. Contrarily to faults, the person responsible
mon reason for consultation, involving 2.8% of all patients and 8.4%
is not aware that a mistake was made. Within a professional context,
of 0–12 year olds (2). Despite its commonness, as any other medical
the disparity between what actually happened and what should have
procedure, vaccination can be subject to errors or faults (3). Vaccination

© The Author 2016. Published by Oxford University Press. All rights reserved.
432
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Vaccine checklist
happened results from one of three categories of error, according to
James Reason (4): (i) routine errors (70% to 80%) due to lapses in
execution or concentration; (ii) failures to apply standard rules for
the procedure (20%) due to errors in mental representation or by
usual difficulties in the application of guidelines; and (iii) knowl-
edge-related errors (less than 10%). The error is remedied by the
person responsible in 80% of cases (5). By contrast, faults are the
violation of a known rule. It is done voluntarily: either deliberately
or negligently, as in cases when clinicians abandon best professional
practice and drift into bad habits (5). Both fault and error involve
the idea of liability and could lead to legal or moral sanctions. Both
may be considered as adverse events related to medical procedures.
In vaccination, the WHO has stated that avoidable adverse reactions
caused by storage or handling problems have proved to be more
numerous than those caused by the vaccines themselves (3).
To identify the trigger of medical errors and especially to estab-
lish how this could have been avoided requires meticulous analysis
of the context in which the action took place. Systematic analytical
strategies have been developed to identify the mechanisms leading to
the medical error or fault. Among them, peer review groups (PRGs)
seek to examine clinical situations and document ways in which the
quality of care can be improved.
Another strategy to improve the quality and safety of care is the
use of medical checklists in order to prevent avoidable adverse events
notably in surgery (6). Therefore, they are recommended by French
regulatory authorities in surgical and obstetric settings. In general
practice, checklists have been scarcely used, in spite of the fact that
GP’s working conditions can fail to promote optimal patient safety
and would be improved by the use of such checklists (7).
The aim of our study was to draw up a checklist in order to
prevent vaccination errors in general practice by analysing common
errors found through 3 sources: a literature search, individual inter-
views with health care workers implicated in vaccination and PRGs
meeting.
Methods
From April to July 2013, we built with qualitative mixed methods a
participatory action research (8) on the subject of vaccination errors.
In another way, we managed to describe an experience of health
quality assessment between peers, bottom-up orientated, grounded
on their daily practice, with a facilitating team and a participant
observation method. To be clear in this chapter, we tried to separate
methods, aims, samples and data they provided. In fact, we used them
not only in this diachronic order but also in a circular synchronic
way. We defined the ‘qualitative data or material’ as an aggregation
of different data kinds: (i) errors and prevention means found in
the literature (second-hand data); (ii) errors and prevention means
collected with interviewed caregivers and within focus groups (first-
hand data); (iii) different checklists that we retrieved (second-hand
data); (iv) the checklist in progress that caregivers and we had built
(first-hand data); and (v) finally, the different opinions of the inter-
viewed caregivers and the research team in respect to the checklists.
Literature search
In order to retrieve vaccination errors reported, we firstly conducted
a literature search using MEDLINE and Google scholar® databases,
without time limits, cross-referencing the following terms: ‘medi-
cation errors’, ‘medical errors’, ‘vaccination’, ‘physician’, ‘general
practitioner’ and ‘vaccine errors’. The reference lists of the included
papers were scanned to identify potentially relevant studies that could
433
be considered. It led us to define which events were to be consid-
ered as ‘errors’ in conflict with good vaccination practices (1,9–12).
Qualitative data about the errors and prevention means were com-
piled for further draw-up of the first checklists. Exhaustive review was
not an aim; according to the subject, the choice of the strategical col-
lection was targeted on ‘kind of errors’, ‘more frequent errors’, ‘lethal
or dangerous errors’ and also ‘papers which described a new error or
gave preventive answers to specific errors we had found’. According
to the priority, it was given to national agencies’ guidelines, big error
databases, but for some technical or specific questions we had to man-
age with pharmaceutical notices, grey literature or blogs (grounded in
daily practise). Literature search was not thought as the first step only;
we returned to the literature every time we faced a new kind of error.
Individual interviews
A qualitative study to retrieve vaccination errors was performed
by face-to-face interviews with GPs and nurses implicated in vac-
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cination. These semistructured interviews were conducted by the
investigator CT and lasted about 30 minutes. The topic list was
‘introduction of the interviewer and the research aims. Could you,
please, tell me about a vaccination error you ever committed? Could
we analyze how to avoid such an error? Please, look at this checklist.
Could we check which errors it could avoid? Are there any items
to be removed or to be added?’ The purposive sampling included
voluntary caregivers involved in post-university sessions of the Saint-
Etienne district (France): a maximal variation had been foreseen
according to their gender, age and paediatric practice.
Collective interviews
Over 4 PRGs sessions (May 2013) in the presence of about 15 resi-
dents, supervised by a GP tutor, vaccination errors were retrieved.
Notes were taken by the investigator CT. The purposive sampling
included groups that had been in place for 3 years and let expect that
trust relationships were built. Both GP tutor and residents show a
similar vaccination practice to their peers, it was confirmed during the
analyzing groups. A 2-hour session was conducted as a focus group,
with the same previous topic list, adapted for a collective purpose.
Analysis, triangulation of qualitative data retrieved
on vaccination errors
All errors retrieved were systematically listed and transferred to
a database (Excel®, Microsoft). The survey was continued until
data saturation was reached (no new emerging type of error).
Errors were encoded manually and classified into three categories
according to the time when they should be prevented: (i) errors
that occurred ‘before’ the vaccination (information on the patient,
receipt of the vaccine and verification of the indication), (ii) errors
that occurred ‘during’ the vaccination (preparing the syringe, set-
tling the patient, injecting) and (iii) errors that occurred ‘after’ the
administration of the vaccine (data of traceability, information
about adverse effects).
Vaccination errors retrieved were then divided into subcatego-
ries by error type and were used to draw up the original checklist
in order to prevent vaccination errors. The checklist versions were
improved step by step after the comments of health care workers
implicated in vaccination, and according to face-to-face interviews
and PRGs meetings. They were finally accepted by all. A team of
researchers, trained in systemic error analysis (involved in national
and local programs as well as PRGs dedicated to primary care
medical errors), carried out several intermediate analyses. Data
analysis was performed from a positivist point of view, with a
434
spontaneous back and forth between practice and literature, giv-
ing a final priority to answers that could be easily compatible with
current general practice. After all, each method reinforced the oth-
ers; all data were coming from many issues; and it was not pos-
sible to distinguish the exact roots, process and results that lead
to the final checklist proposal: rather than a weakness, this was
foreseen to be the strength of the study (Fig.  1). The stabiliza-
tion of the checklist was judged as an evidence of finalization: no
common vaccination error could resist to the final checklist that
seemed to be easy to use and understood by all. No large-scale
study was foreseen at this first stage.
Ethics
The only data collected were on errors, not on patients, so no decla-
ration was made to the French Data Protection Authority. No dec-
laration was made to the ethics committee for this research on the
quality of care: mortality and morbidity reviews, groups for analy-
sis of practices, audit of practices, collection of data and reports on
research initiatives, instigated by the French health authorities, are
integral to the mandatory accreditation of establishments as well as
the certification of practitioners.
Results
Qualitative collection of vaccination errors
A total of 15 documentary references were retained with the litera-
ture review (3,9,10,13–24), 9 were published studies (13–20,23),
and other documents were from newsletters of French Agency for
the Safety of Medicines (ANSM) (9), Infovac-France (an interactive
website where physicians could ask questions about vaccination)
(21), WHO (3,22), National Patient Safety Agency (NPSA) (24), data
from pharmaceutical companies’ correspondence (10) and blogs by
GPs on their vaccine-related errors (25).
Figure 1.  Mixed methods: from aims triangulation to final checklist proposal
Family Practice, 2016, Vol. 33, No. 4
Individual interviews involved 23 physicians (21 GP, 1 lung spe-
cialist and 1 otorhinolaryngologist) and 2 nurses, while 54 residents
were questioned collectively within PRGs.
Using these three sources, 28 types of error were identified from
the literature review, 17 types of error were reported during individ-
ual interviews with physicians and 26 types of error emerged during
collective interviews within PRGs. Therefore, 71 types of different
errors were listed, some of which overlap (three sources). For this
research which focused on the typology of the incidents observed,
it was not considered relevant to provide other quantitative data.
When specific vaccine devices were to blame for an error (needle or
syringe supplied by the manufacturer), only the mechanism leading
to the error was summarized.
Errors arising ‘before’ vaccine administration are summarized in
Table 1. These errors concerned the prevaccination steps, until admin-
istration of the vaccine by the physician. Types of errors included
mainly errors on the patient’s vaccine status, the indication and the
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vaccine product. Errors occurring ‘during’ the preparation and admin-
istration of the vaccine are shown in Table 2. Errors occurring ‘after’
administration are shown in Table 3 and mainly concern traceability.
The proposed checklist
The drawn-up checklist was modified several times before being
accepted by the health care workers involved in the study. The final
version of the checklist is presented in Table 4. Items to be checked
aimed to prevent the corresponding errors. Certain items (such as
compliance with contraindications or disposal of needles) were sel-
dom reported as errors, but because they concern safety, we regarded
them as essential and included them. The number of verification
points per column was limited to five in order to facilitate the accept-
ability and feasibility by GPs. Intradermal BCG vaccination is associ-
ated with specific errors (9). We therefore drew up a specific checklist
(Table 5) to prevent specific errors.
Vaccine checklist 435

Table 1.  Errors recorded prior to vaccine administration—literature review, face-to-face interviews with GPs and focus groups, 2013

Authentication of vaccination status

*No written record of previous vaccinations: health or vaccination record lost, forgotten, inaccessible in a hospital department or retirement home
Date of vaccination
–Error in the interval between doses for a vaccination programme: in most cases, too soon
–First vaccination before the age indicated in the marketing authorization (MA)
Indication
–BCG given to hospital staff without direct contact with patients (person in charge of mail deliveries, gardener)
Wrong vaccine dose or valency
–Inappropriate prescribing
*The patient brings a vaccine prescribed by another health professional or handed over in advance by a pharmacy
*Overdose (HB 20 µg vaccine in a patient under 15 years of agea, DTaP-IPV vaccine instead of Td-IPV for a patient over 6 years of age), or an insuf-
ficient dose (DTaP-IPV instead of Td-IPV for a child)
Product quality
*Injection of a time-expired vaccine
–Vaccine injected after exposure of more than 24 hours to ambient temperature or more than 4 hours after reconstitution (BCG)
–Cold chain break (refrigerator not monitored, freezing, thawing)
Consent of parents or patient

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–Prescribing or injecting recommended but non-mandatory vaccine valencies in patients hostile to the vaccination (mainly hepatitis B)
Prevaccination (or final) checks
*Failure to read the name of the vaccine prior to injection, so consequent failure to detect earlier errors in delivery or prescription (confusion of
names, date or packaging)
–Injection of vaccine intended for another patient
–Failure to respect contraindications

When the prevalence of a particular type of accident appeared significantly higher, it was indicated by an asterisk instead of a dash.
a
Exception: between 11 and 15 years of age, the French schedule allows the HB 20 µg vaccine for the two-vaccine programme, with an interval of 2 months
between the two doses.

Discussion Among posted questions, 10% of them are related to vaccination

Epidemiology of vaccine errors
Globally, hundreds of millions of doses of vaccine are administered
each year; however, errors in the vaccination process have received
scant attention. Vaccination errors may have nevertheless a number
of consequences: epidemiological (lack of immunization and pos-
sible propagation of an epidemic), human (overvaccination without
benefit to the patient, adverse effects) and financial (19). Another
potential consequence is the rise of scepticism about or refusal of vac-
cinations, especially among parents, in case of vaccine errors. In this
study, we collected an overview of qualitative data about vaccination
errors from literature and from evidence given by practitioners. The
diversity of these sources yielded a more accurate description of the
reality of vaccination practice and allowed us to create a preventive
checklist on vaccination errors.
In the USA, the VAERS (Vaccine Adverse Event Reporting
System) constitutes a data source that draws on 49 reports of vacci-
nation errors. The two most common errors belong to the categories
of ‘wrong injections’ (30%) and ‘interval errors’ (16). A  survey in
the USA assessed the extent of excess vaccination on 32 742 chil-
dren aged 19–35  months (19): 21% of children were affected by
excess vaccination. The follow-up care of young patients’ immuniza-
tion by several different health professionals was a risk factor, and
children who were seen only in vaccination centres were much less
likely to be overimmunized. Another study analysed 607 reports of
vaccination errors derived from MEDMARX, a register of adverse
drug effects from 400 health care establishments in the USA, aiming
to predict vaccination errors (14). The errors appeared to be related
either to the vaccines or to human factors, and efforts to reduce their
incidence should focus on the latter. In France, the Infovac website
(21), a reliable source of information not funded by the pharma-
ceutical industry, involves around 5000 French physicians, consult-
ing and posting more than 2000 questions on vaccines each year.
errors. These data confirm that in most cases, vaccination errors
may be prevented and a checklist would offer a potential means of
prevention.
The checklists in the field of health
In the surgical area, since 2000, different safety checklists have
been developed to reduce avoidable morbidity and mortality.
Those checklists had been shown effective in reducing surgical
complications, wound infections and blood loss (6). The French
National Authority for Health (HAS) has drawn inspiration from
this checklist and brought together a working group to develop
an adapted version. The list consists in 24 criteria, 12 of which
being the same as those of the original validated checklist. It is
appropriate for all types of surgery but can be changed by each
surgical team to turn it specific and relevant. Despite being not
mandatory, since 2010, its use has counted towards the certifica-
tion of a health care institution and therefore encourages health
care workers to use it (26).
Checklists have also been used in other non-medical areas such
as aeronautic and prevent human errors with potential fatal conse-
quences (26). In the field of infectious disease, the Infection Control
Checklist offers a good example of an application for caregivers to
have an appropriate practice and avoid infection transmission (27).
For vaccination errors, no user-friendly checklist existed to date
despite some attempts. Recently, the Public Health Agency of Canada
published within vaccination guidelines a non-exhaustive checklist
organized similarly to ours: prevaccine administration checklist,
vaccine administration, postvaccination counselling and observa-
tion. However, due to the high number of items to complete and
additional justifications needed, it appeared more useful for PRGs or
mortality and morbidity review groups’ analyses than for GPs’ daily
practice (28). The Infovac website (20) proposed a decision tree with
436 Family Practice, 2016, Vol. 33, No. 4

Table  2.  Errors recorded during preparation and administration of the vaccine—literature review, face-to-face interviews with GPs and
focus groups, 2013

Distracted by an external event: disturbed by telephone call, noisy atmosphere

–Loss of equipment: vaccine solvent mislaid at the time of preparation or needles not found in the bottom of pack
*Clumsiness: thumb left on valve and pressure applied without realizing (2/3 of vaccine lost), glass vial dropped and broken on floor, excessive trac-
tion and disconnection of valve, slippage of the powder vial stopper and loss of half of the liquid part, removing the needle too quickly from the
patient’s arm, while the valve was not completely pushed down (loss of vaccine)
Wrong or forgotten procedure
–Forgetting to disinfect the injection site
–BCG: unsuitable syringe or needle used
–Needle-stick injury as injector replaced cap on needle
Preparation of vaccine and syringe
*Reconstitution: forgetting ‘powder–solvent’ reconstitution, reconstitution with the wrong solvent in a double vaccination (wrong way round)
*Needle–syringe adjustment: during injection there is resistance when the valve is pushed down; the syringe is the wrong size for the needle and the
vaccine is overpressurized and ejected; a case of BCG vaccine coming into contact with the eyes has been reported
*Flushing: forgetting or omitting to flush, excessive flushing with a sudden movement that forces part of the liquid out of the syringe
–Dose: injection of 2 ml of BCG or 0.5 ml of influenza vaccine in a child less than 36 months old.
–Lack of technical knowledge or experience with regard to using certain devices: automatic retractable needle system, BCG

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Identification of injection sites and routes
*Administration route error: subcutaneous (SC) instead of intramuscular (IM) injection, part of the vaccine diffused subcutaneously although the in-
tention was to inject via IM: use of 25G (Orange) needle for IM injection in an overweight adult, IM instead of intradermal (ID) injection for BCG,
oral vaccine administered by IM route
–Site error: 2 vaccines in same quadriceps muscle in an infant, injecting a site other than the 1 specified in the MA (in an infant, the buttock instead of
the quadriceps muscle, effect of a poorly positioned anaesthetic patch, patient insisting on having the BCG injection in the buttock)
Getting the patient ready, technique affecting pain
–Consultation for multiple reasons: the vaccine was forgotten and the patient has already left
–BCG with no help to hold an infant
–Mixture of vaccines: MMR and Td-IPV, or meningococcal vaccine and DTap-IPV to avoid painful injections (deliberate act contrary to MA indica-
tions, deliberate fault despite commendable intention)
–Injection speed too slow or too fast
–Vaccine injected into a very tense and crying child: a few drops of vaccine expelled

When the prevalence of a particular type of accident appeared significantly higher, it was indicated by an asterisk instead of a dash.

Table 3.  Errors recorded postadministration of the vaccine—literature review, face-to-face interviews with GPs and focus groups, 2013

Fate of equipment used

–Waste not dealt immediately (needles in particular)
–Use of the same syringe on 2 successive patients in a context of ‘assembly line’ vaccination (context: AH1N1 flu epidemic)
Monitoring of the patient and the person accompanying him/her
–Situation of vasovagal syncope within 5 minutes in vaccinated patients who stand up too quickly (example: fall with head injury sustained and
admission to Intensive Care (13-year-old girl) following a double HPV and meningococcal injection)
–Rare anaphylactic reaction after the injection
–Vasovagal syncope in the accompanying parent after double vaccination of his/her infant
Traceability
–Forgetting to register the procedure on the vaccination and medical records: syringe and box discarded just after the vaccination, a vaccination noted
in the record before an injection that is ultimately deferred (increased risk of the injection being forgotten later), failure to perform double entry
(patient record–doctor record), confusion between two sets of medical records (homonyms) or two records (brother and sister)
Patient information
*Date of reminder, type of vaccination: wrong memo on the medical software or line error on the prescription assistance software, failure to indicate
the next vaccine to be done, certainty that the patient has understood what disease he/she is protected against (for example, flu and not pneumococ-
cal pneumonia), emergency situation with treatment given by another medical professional (wounds and tetanus vaccination)
–Anticipated side effects: BCG: warning about local reaction with induration or ulceration at the injection site and/or infracentimetric satellite ad-
enopathy, localized pain at the injection site and possible use of paracetamol if discomfort. In hepatitis C virus (HCV) or human immunodeficiency
virus (HIV) screening, false positives are more likely: avoid performing such tests after certain vaccinations

When the prevalence of a particular type of accident appeared significantly higher, it was indicated by an asterisk instead of a dash.

6 questions, depending on answers given, authorizing or prohibit-
ing the vaccination procedure. Three additional recommendations at
the end (BCG dose, disinfection and administration route) were also
added. This proposal was designed to improve vaccination safety
but focuses mainly on the points that should be verified prior to
injection, while the checklist developed in our study included items
to be checked during the three stages of the consultation, as errors
occurred in these three stages.
Vaccination checklist: limits, benefits and
expectations
The checklist presented here is simple, seems easy to use and adapted
to daily and current general practice. The points for verification are
succinct and listed in chronological order allowing safety prepara-
tion of each stage of vaccination process and are not time-consuming.
Items included in the checklist aimed to prevent the most common
errors. Errors or oversight that could have severe consequences were
Vaccine checklist 437

Table 4.  Final proposal of a checklist for vaccine administration—construct and content validation through face-to-face interviews with
GPs, 2013

Before administration of the vaccine During preparation and After the vaccination
administration of the vaccine

Vaccination status documented? Am I focused, calm atmosphere, Disposal of needles in special

telephone turned off? container?
  Vaccination card   Yes ☐    No ☐   Yes ☐    No ☐
  Health record
  Medical records
  Yes ☐    No ☐
Is it the right vaccination date? Equipment within reach? (epinephrine, compress, Is the patient seated or lying down
  Yes ☐    No ☐ antiseptic, dressings, container for medical waste) for 15 minutes after the procedure?
  Yes ☐    No ☐   Yes ☐    No ☐
Vaccine quality: Preparation of vaccine syringe: Traceability ensured?
  Not out of date?  Reconstitution   Vaccination noted on health
  Storage conditions?   Needle placement record and medical records

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  Yes ☐    No ☐   Flushing   Next vaccination noted?
  Yes ☐    No ☐   Yes ☐    No ☐
Absence of contraindications? Site and route (IM/SC) of injection Informing the patient:
(undocumented neurological disorder, properly identified?   Anticipated adverse effects?
immunodepression, allergy, fever)   Yes ☐    No ☐   Recall date, if any?
  Yes ☐    No ☐   Yes ☐    No ☐
Packaging checked in front Patient (and family) relaxed: Notification of an adverse
of the patient: seated or lying down? event if applicable?
  Right vaccine?   Yes ☐    No ☐   Yes ☐    No ☐
  Right dose?
  Yes ☐    No ☐

Table 5.  Final proposal of a checklist for BCG administration—construct and content validation through face-to-face interviews with GPs,
2013

Before BCG administration During preparation and administration After vaccination

Absolute contraindications No local anaesthesia Warn that a benign pustule can

  Acquired or congenital immunodepression Apply modified alcohol and appear at the injection site
  HIV+ mother and child not screened await complete evaporation
Temporary contraindication Patient immobile Explain what to do:
Generalized infective dermatitis, fever An assistant should be present   Expose the arm to air
if patient is a child   Dry compress
  No antiseptic
  No ointment
Absence of tubercular disease Route: intradermal Advise bringing patient back if:
Site: posteroexternal surface of   The pustule is >3 cm;
deltoid muscle only   There is a loss of strength in the arm;
 Large and fluctuating axillary
lymphadenopathy
Absence of scar Quantity: Inform: symptoms can persist for
  Indicating previous vaccination   0.05 ml = child under 1 year old 3 months, but clear up spontaneously
  0.10 ml = child over 1 year old

also included, even rare. For example, despite an immediate anaphy-
lactic reaction being an extremely rare complication of vaccination,
we included in the checklist to verify having ready-to-use adrena-
line at hand (1). Errors related to failures in competence were not
included in the checklist as they could not be quickly corrected and
needed training (9). In the same way, the checklist does not include
vaccine guidelines that are updated annually and published since
2014 by the French Ministry of Health (29). Practitioners should
be aware of these updates in order to remain in agreement with the
recommendations. The checklist does not aim to act as a substitute
for this. Compliance to the current vaccination schedule and the use
of the checklist would be complementary.
Built on a hospital model, the organization of vaccination centres
is intended to limit errors as much as possible with different levels
of control for patient vaccine status, vaccine storage conditions and
information of patients. In general practice, the same resources can-
not be deployed, therefore, the use of such a checklist aiming to help
controlling the same items and prevent errors is even more impor-
tant. Potential errors linked to the manufacture and packaging of
vaccines could not be prevented by our checklist. This underscores
the remaining importance of notifying incidents to the respective
authorities and firms. A  shared electronic vaccination card (on a
protected and dedicated website) should also be a shield against vac-
cination errors.
438
Conclusion
In conclusion, vaccination errors exist and can be avoidable. Based
on the most frequent errors and on errors with potential severe
consequences, we created a checklist usable at the three stages of a
vaccination act. This checklist was improved and accepted by prac-
titioners and nurses implicated in vaccination in their daily practice.
Further studies are needed to test and evaluate the accuracy of the
checklist in real life.
French Data Protection Authority (CNIL)
Only data on errors (and not people) was collected: no declaration
was necessary.
Acknowledgements
The authors thank all the caregivers and the residents who accepted to analyze
their vaccine errors. The authors also thank Hélène Krzepisz for English edit-
ing. Authors’ contributions: CT interviewed the health care workers; literature
research was performed by RC and CT; RC, JV, CT and FL conceived, coordi-
nated and designed the study. RC, JV, FL and EB-N wrote the manuscript. All
authors have read and approved the final article.
Declaration
Funding: Department of General Practice, Jean Monnet University, School of
Medicine Jacques Lisfranc, Saint-Etienne, France.
Ethics approval: mortality and morbidity reviews, groups for analysis of prac-
tices, audit of practices, collection of data and reports on research initiatives,
instigated by the French health authorities, are integral to the mandatory
accreditation of establishments as well as the certification of practitioners: no
declaration was made to the ethics committee of this research as regards the
quality assessment in health care.
Conflict of interest: JV is volunteering in the programme ‘Avoiding the avoid-
able’ (available for subscribers), an initiative by the journal Prescrire. Others
authors declare no conflict of interest.
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