Professional Documents
Culture Documents
www.elsevierhealth.com/journals/siny
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doi:10.1016/j.siny.2004.09.014
46 J. Madar
few special circumstances dictating a unique re- competence and appropriate training of all
sponse. professional staff.
6. Health records: A comprehensive system for
Hierarchy of organisational awareness the completion, use, storage and retrieval of
health records is in place. Record keeping
Organisational vulnerability standards are monitored through the clinical
audit process.
Unconscious Liability
7. Implementation of clinical risk management: A
Unaware of shortfalls, problems
clinical risk management system is in place.
Conscious Liability
8. Staffing: Maternity services must provide safe
Aware of shortfalls, problems
Conscious Contingency
care for mothers at all times.
Specific plans for specific identified liabilities
Unconscious Contingency
Comprehensive systems operating cover even unexpected liabilities Steps in the process
Table 1 Some generic hazards in resuscitation at birth and to whom they might apply
Hazard Baby Resuscitator Other Prof Parents Organisation
Death X
Short term
Physical morbidity X X
Mental morbidity X X X X
Metabolic morbidity X
Long term
Physical morbidity X X
Mental morbidity X X X X
Neurodev morbidity X
Professional damage X X X X
Fiscal damage X X X
Table 2 The proportion of deliveries attended by Table 3 Numbers of babies requiring resuscitation
a doctor summoned at or after delivery, and including cardiac compressions or drugs in two
the numbers requiring airway intervention in a typi- different types of centres in the USA and UK
cal large UK DGH using guidelines such as those Location Texas Plymouth UK
discussed 1991e19929 1993e1999
All risks, all gestations, Low risk, Total births 30,839 30,400
n Z 17,890 R 32 weeks, Total ECC 39 (0.12%) 81 (0.27%)
n Z 11,461 C/ÿ drugsa
Doctor at Doctor after Doctor after ECC only 21 65
delivery delivery delivery ECC C drugs 14 7
Total 5133 948 477 Drugs only 4 (adrenaline) 9 (unspecified)
attended a
Not including naloxone as a drug of resuscitation.
Minimal 3867 (75%) 529 (56%) 193 (40%)
intervention
Mask inflation 852 (17%) 286 (30%) 275 (58%) to differentiate those with a very poor outlook,
Intubation 175 (3.4%) 133 (14%) 9 (2%) who tend to be acidotic and/or preterm (Figs. 1
Derriford Hospital Plymouth (UK) hospital resuscitation and 2).9
data.8 Retrospective analysis of resuscitations where
cardiac compression or drugs were required sug-
Similarly, when called, resuscitators are not gested that in a significant number of cases
always needed (effectively a false positive sum- problems related to a failure to adequately ad-
mons). The more mature the baby, the less likely dress the airway and breathing.9
they are to require resuscitation (Table 2). It is important to be aware of trends within
The specific indicators for attendance in any departments. The ability to review local data may
unit may vary. However, typical indications to identify changes in practice or outcome that
summon help before delivery might include: highlight areas of good practice, or those where
matters need reviewing (Fig. 3).
preterm deliveries, Observational data in this series appear to
emergency caesarian sections, demonstrate a decreasing tendency in the use of
breech deliveries, drugs, which may reflect educational initiatives on
thick meconium staining of the liquor, newborn life support introduced around this time.
multiple pregnancy,
maternal conditions potentially affecting the A hierarchy of risk
baby,
prior identified fetal problems, There is hierarchy of risk in delivery to consider.
other occasions if requested by obstetric staff. For example, which poses the greater risk? 1: A
delivery where there are definite problems identi-
The need for intervention at birth does not in fied in utero, but where as a result, everyone is
itself predict a poor outcome. In the above series, prepared, or 2: A delivery perceived to be un-
the overall incidence of moderate or severe early complicated but where some unexpected catas-
neonatal encephalopathy was 0.10%, and that of trophe results in a severely compromised baby in
meconium aspiration syndrome 0.15%.
The response to resuscitation e or lack of it e ECC +/- Drugs
may indicate a disease severity that heralds prob- 39
and provided with training e such as a Newborn Life original birth plan. There need to be clear guide-
Support Course, plus ongoing support. lines/protocols defining the thresholds upon which
discussions/decisions take place. If the mother is
Summary delivering in an out of hospital setting, then there
need to be appropriate contingencies for obstetric
Attention to the ongoing process of labour and an or neonatal emergencies.
awareness of the possible outcomes and resources Geography may be a confounding issue with
available are essential in modifying events to unplanned deliveries such as a preterm precipitate
minimise the possibility of an adverse outcome. delivery at home, or in an accident and emergency
department. Planning for these should consider
the environment and equipment available, trans-
The domains of risk port issues, the ability of local staff to cope, and
how specialist staff would be summoned and their
There are different areas that need to be consid- ability to deal with the problem(s).
ered when considering risk.
Clinical setting
Environment The ideal environment should facilitate, not hinder
B Location the resuscitation of a baby in difficulties. Rooms
B Clinical setting should be of appropriate size that crowding does
B Equipment not compromise the delivery of the baby, should be
Staffing draught free and of an appropriate temperature.
B Establishment There should be an accessible area where the baby
B Induction, training, competency can be assessed and support required provided.
Logistic There should be unhindered access to relevant
B Process and timing equipment; it should be free of unwanted interfer-
B Workload intensity ence such as excessive noise, be provided with
B Communication appropriate communications and be private.
Priorities vary. Good thermal control is essential
as this may affect outcome. However, the pres-
Environment ence of excessive noise might not materially affect
resuscitation, unless it was sufficient to impair
Location rational thought or communications. Privacy is
A delivery can take place in hospital, a planned desirable, but not essential in practical terms.
birthing centre (midwifery led unit), at home or The commissioning of a delivery unit affords an
occasionally elsewhere. The ability to deal with opportunity to specify room dimensions, layout and
problems is significantly affected. support services such as piped air/oxygen. Other-
Deliveries are ideally planned between the pa- wise it is a matter of reviewing existing arrange-
rent(s) and the midwifery/obstetric care team as ments. Whilst not yet mandatory, the ability to
part of the risk management process. Delivery is blend gas should arguably be available10,11 and
a potential hazard and factors operating during the consideration of the means by which this (and
pregnancy might mandate a recommendation for compatible equipment) is provided. If no piped
delivery in a different place, or with different staff. air is available bottled air may be considered an
Mothers may choose to deliver in a hospital setting effective alternative, issues arise with respect to
where it is perceived that should problems occur, supply and storage. Birthing pools are an example
the systems to deal with these are in place. Others of a potentially challenging environment, which
choose to deliver at home or in a midwifery led unit demand clear guidelines. Achieving adequate ther-
not linked to major hospital services. In these cases, mal control may be difficult in the cooler and often
the ability to deal with certain problems is reduced. draughty setting of theatre where the (often
Any risk management process needs to consider the compromised) baby is exposed prior to transfer to
potential scenarios where problems might occur the resuscitation area. Home deliveries have chal-
and respond. In preventative terms, perceived risks lenges. It is possible to keep the place of birth
might be managed by recommending a change of warm, but space, lighting and support infrastruc-
venue from home to hospital as with antenatal ture e among other factors e can be problems.
issues such as pre-eclampsia or multiple pregnancy, Those undertaking delivery and resuscitation/sta-
or with perinatal problems such as a preterm labour bilisation need to understand their environment
where it is inappropriate to continue with the and have strategies to deal with restrictions.
Clinical risk management in newborn and neonatal resuscitation 51
who move between units must be made aware of system of review and maintenance. Clear retriev-
details. Where possible intra-unit variables should able documentation of the process should be kept.
be minimised/removed. It is essential to be aware of any issues pertain-
Stock-keeping is more complex with multiple ing to the equipment which may adversely affect
types. For example e laryngoscopes vary in size its ability to perform appropriately. Systems
and shape of blade. Fibre optic illumination alters should be in place to allow items of concern to
blade profile, makes it impossible to lose bulbs into be identified to those responsible for upkeep.
the pharynx, and allows for disposable plastic Documentation must be robust. Any process needs
blades. Departmental or trust wide policies on to include reference to relevant external agencies
provision may be relevant. If many different types such as the MHRA (Medicines and Healthcare
are in use, then the multiplicity of spares can be Regulatory Agency (UK)).
a problem and users will need to be familiar with Strategies should be in place to plan for re-
the differing characteristics. placement of those items likely to wear out, or
Ensure a fail-safe approach. Alternative means deemed unserviceable on other grounds.
of undertaking interventions should exist. Contin- User has responsibility. Ultimately the user of
gencies should be made for any system failure at the equipment has a responsibility to ensure it
any level, in any environment. Ideally, duplicate functions as expected or is identified as failing in
equipment should enable resuscitation to be un- time to seek a replacement. In all clinical situa-
dertaken or continue even the primary systems fail tions it is essential to check all functions before
completely. resuscitation. Of course this is not always possible
Eg: Should wall gas supply fail, then the cylinder but as a rule, assumptions should not be made
supply provided on a resuscitaire should allow about the integrity of any equipment. Failure to
continued support. However, cylinders leak if left identify a lack of provision in advance may com-
on circuit, and such systems are used rarely, and promise the ability to resuscitate effectively.
thus it is important that these are checked regu-
larly and that staff are aware of how to use them. Summary
Other examples are the provision of two sets of
laryngoscopes to allow for failure of the first set, or The equipment used in a resuscitation, whether in
the availability somewhere in the department of delivery suite, home delivery or elsewhere must be
a self inflating bag should T-piece or gas circuits subject to a rigorous policy of upkeep with those
fail. Staff should be aware of such contingencies. using the equipment subject to an equally rigorous
Ensure training in use. It is essential that staff policy of training. These processes must be regu-
are trained. It is dangerous to make assumptions larly reviewed and any information retrievable in
and it is necessary to be able to demonstrate that order to demonstrate, should it be necessary, that
staff are trained. Therefore, any programme of appropriate systems operated to minimise the
induction, or ongoing education must not only likelihood of failure of either kit or operator.
provide the facility to train, but also to document
competence in the use of the equipment. This Staffing
needs to be ongoing with regular review as policies,
equipment e and staff e change with time. How Establishment
such a programme is implemented is a departmental Guidelines exist on the numbers and competency
matter, but requires identified trainers with time of staff that should be available to deal with
apportioned for the task. For example e those using delivery situations (summarised for the UK in the
a resuscitaire should know how to set it up, how any CNST maternity standard No. 81) within hospital or
pressure regulated system works, how the suction is domestic settings. Ensuring adequate numbers are
provided, what is stored in the drawers, what to do available to work can be a challenge. Service
if primary systems such as gas supply fail etc. planners need to ensure adequate numbers of
Ensure robust and accountable schedules for staff are employed.
checking and servicing. The failure of equipment, Workload varies, and the baseline establishment
or a lack of serviceable equipment adversely of staff may be inadequate at times. Contingencies
affecting a resuscitation attempt is difficult to to enable the service to cope should exist. These
defend. There should be clear delineation of might involve extra staff or, where it is felt matters
duties and responsibilities with respect to mainte- approach dangerous levels, temporary closure of
nance. There must be a clear structure for the the unit. Accurate information, clear guidance and
checking and restocking of any resuscitation equip- access to relevant senior staff able to make in-
ment after any use in addition to any ‘routine’ formed, balanced decisions on these matters are
Clinical risk management in newborn and neonatal resuscitation 53
important to have clear mechanisms on obtaining Ensuring all new staff undergo formal NLS or
appropriately skilled help. equivalent training at least gives those with no
prior background in newborn resuscitation some
Evolving standards of care training and works towards a common approach
Staff should be up-to-date with current practice during resuscitation situations.
and recommendations.14e16 Staff and departments
need to actively review local standards of care to Delivery of training
reflect these.17 Recent issues include the appro- Institutions must resource properly structured
priate timing for elective caesarean section de- training; a major issue is time. Staff must be
liveries,18,19 the use of room air or blended oxygen released to attend relevant educational activities.
rather than 100% oxygen,10,11,20 the use of poly- Members of the clinical establishment should be
ethylene wrap/plastic bags to optimise thermal credible trainers and be supported in developing
care in the extreme preterm baby,21 optimal their educational and mentorship skills.
neuroprotective thermal care for the hypoxic in- Training initiatives have evolved over years. The
fant;22 the optimal way to assess the heart rate involvement of interested clinicians, educational-
(using a stethoscope);23 the use of laryngeal mask ists and the application of learning theory have
airways;24 the potential use of pulse oximetry25,26 had a significant effect on recent efforts in the
and capnography27 in the delivery room situation. field.29
The prerequisites of a good training programme
Individual staff requirements are:
Individual staff needs should be identified through
a defined process of performance review or ap- 1. provision of the relevant knowledge and skills
praisal. Ascertainment of the skills/knowledge of in appropriate form,
the individual can then be translated into a strat- 2. opportunity to practice until competent,
egy for updating/refresher training. This review 3. appropriate support in the clinical environ-
takes place against a defined set of departmental ment,
standards, which conform to any relevant internal 4. robust mechanisms for review.
(organisational) or external standards.
Assessment needs to be pre-emptive and ongo- Courses provide knowledge and develop skills,
ing, commencing before or soon after appointment consolidated whilst ‘learning on the job’. Practice
and subject to review. Clear documentation of the is informed by clinical exposure. Undertaking re-
assessment process and progress/development of suscitation within an appropriate supervisory
competencies at an individual level is essential. structure underpins clinical practice. Whatever
This may inform future review, reflective learning methods are used prior to working in the field,
and may be important should any issues (internal consolidation takes place in the field.
review, complaints, legal action, etc.) arise re-
lating to specific resuscitation events. Increasingly Formal courses
such aspects are incorporated into regulatory A current vogue involves short, intensive training
structures such as those of the NHS litigation courses e often over 1 or 2 days. Written material
authority.1 and lectures provide knowledge. Skill stations and
It is essential that staffing levels and skill mix clinically based simulated scenarios develop psy-
acknowledge individual competency and do not chomotor, evaluation and team leadership skills
result in those inexperienced being expected to such that all members collaborate effectively.
carry out tasks without support. They aspire to set a baseline standard, deemed
to have been achieved by virtue of formal sum-
Induction/training mative assessment.
It is perilous to make assumptions about the basic Within the United Kingdom, the Resuscitation
level of competence of new staff, in particular Council (UK) supports the Newborn Life Support
medical staff who rotate through departments (NLS) course,12 a course developed in the UK,
frequently. Someone who is properly trained in based around UK clinical practice, which operates
a given task is more likely to perform that task under their regulations and quality control sys-
better. This premise drives many initiatives in- tems. This course is supported/endorsed by all
cluding training in the knowledge and skills per- the professional bodies involved with staff re-
taining to resuscitation e with some evidence to sponsible for babies in the newborn period and, in
support such efforts.28 The precise manner and this country is seen as the current standard in
frequency of such training and the mechanisms by training in the initial assessment and support of
which its effectiveness can be assessed is less clear. a newborn baby. Similar courses exist in other
Clinical risk management in newborn and neonatal resuscitation 55
parts of the world, such as the Newborn Re- and confidence. The confident but incompetent
suscitation Program (NRP), supported in North staff member is a liability who needs to be
America.13 It might be expected that staff in- identified.
volved with babies at birth hold a current certif- Asset
icate in one of these.
These courses do not claim to make staff Competent, Confident
competent in newborn resuscitation, but provide Able to perform, happy to do so – relatively low risk
in the mainstream. The concept of such retrievable refrain from documenting opinions unless fully
records might be intimidating to those involved. supported by sound evidence.
There are critical time frames with respect to
Documentation resuscitation at birth.
It is essential that clear records of any training are
kept and are retrievable. This is important at the
individual level and forms part of any portfolio. For Antenatal
the institution a record of staff competencies is Neonatal staff needs to be aware of any prior
essential when considering the clinical standards obstetric discussions and vice versa. Appropriate
around which a unit operates as well as for any staff should be involved. Senior staff aware of all
specific clinical situation where it is necessary to the potential issues and able to inform parents of
review the skill base of the staff involved. true expectation and likely outcome should coun-
sel those expecting a baby in circumstances which
Summary may be complicated e e.g. extreme prematurity,
congenital abnormality, from which an agreed
The provision and monitoring of appropriate train- strategy for the birth should evolve.
ing within a department is essential to place staff Any discussion with parents including those re-
in the best position to be able to provide appro- quiring consent or assent need to be underwritten
priate care and reduce the potential for adverse by robust evidence based clinical guidelines and
events. Adequate resources need to be in place to information where possible. This should include not
achieve this. just national data,40e42 but local outcome data.43
Information should be available for parents in
Logistics various formats to acknowledge differences in their
ability to absorb information. Language and cultural
Process differences can be a major pitfall unless contingen-
The resuscitation of a baby is part of a process cies are made, including multilingual leaflets, and
which begins in utero and ends after birth. In- accessible interpreters. Where critical life deter-
tervention at various points may significantly mining decisions are to be made qualitative studies
affect outcome. A situation where a resuscitation suggest parents may not wish to be the final arbiter
in less than optimal circumstances was required of outcome, but they need to be well informed and
might have been avoided had other decisions been their views acknowledged during the process.44
made earlier. Therefore it is essential that the
whole process is critically reviewed.
Data on cases dealt with by the NHSLA suggest Perinatal
a significant number of adverse events relate to For any maternity department the guidelines on
failures in process, where earlier definitive action who to call for resuscitation and when need should
before delivery might have resulted in an altered be clear. The mechanisms by which the teams are
outcome (personal communication). called (typically via switchboard/bleep systems)
need to be clearly specified and staff need to
Communication understand what to do if initial attempts to call for
Good communication at all levels is a vital part of help are unsuccessful.
the risk management process whatever the subject During a resuscitation communication is equally
matter. This is acknowledged through the CNST vital, not just between those involved with the
standards1 of which 2 out of 8 deal with matters of resuscitation efforts, the delegation of someone to
communication and documentation. Systems or record accurately the key events and if necessary,
root cause analysis39 often reveal that problems drugs given, may be useful when retrospectively
arise because of breakdowns in communication at reconstructing the sequence of events.
various levels. The parent(s) are likely to be witnesses to the
In any given clinical situation, the matters event. In childbirth it is impossible/unreasonable
discussed between staff and between staff and to exclude them. Their subsequent recollection
parents need to be unambiguous, clearly docu- and interpretation of events are likely to be very
mented and accessible to others where appropri- subjective, but may be critical in any ensuing
ate. Any discussions should be clearly recorded in review. The ability to identify a member of staff
a manner that facilitates later review. Clear to deal with the parents and to acknowledge their
guidance should be provided to staff to ensure presence may be vital, if sometime difficult in
they are able to record all relevant facts and to fraught circumstances.
Clinical risk management in newborn and neonatal resuscitation 57
gases would be missed by this practice e 31/42 There is some debate as to where to measure
values in O4000 spontaneous cephalic deliveries the values from. Conventionally cord arterial blood
(Derriford Hospital Perinatal Research Group e analysis is quoted as it is felt to better reflect the
personal communication). A few feel that the baby. Paired samples are often recommended as
process of obtaining cord gases may be potentially they allow discrimination of the artery with a com-
harmful by preventing physiological placental parison of paired values from both artery and
transfusion of blood after delivery.56 vein;52,61,62 others find no difference between
The relationship between cord blood acidosis arterial and venous values48 although this might
and outcome is not a secure one. Even when the reflect inadvertent sampling from the same vessel
cord gases have been significantly acidotic (commonly the vein). The site of sampling along
(pH % 7.00), babies have subsequently had no the cord may have a significant effect on values.63
detectable problems in the short or the long Cord gas values are used with other markers of
term.46,51 Conversely, significantly unwell babies fetal stress to improve sensitivity and specificity.
may have cord gases above pH 7.00 in the normal However, opinion differs as to the best markers.
range (Fig. 4) and may well have a poorer The Apgar score is advocated as a structured
outlook.57 Acidaemia may not reflect cellular indicator of fetal well-being. Some use the 5-min
acidosis in some situations. score (48.49) with a value !7 taken as the
There is variance in the parameters measured threshold indicator of compromise. However, de-
and the interpretation placed upon these. The pH spite the preference for the 5-min score by many,
in isolation has been used as the measured vari- others argue that the 1-min score is a better
able.46,50 Measurement of the base deficit in discriminator.6 Or that there is but a weak corre-
conjunction with this is advocated48,58,59 because lation with the measured blood variables.51,52
it reflects the metabolic component of the pH. Some present no data on Apgar but use alternative
Interpretation of the pCO2 may have value52 in markers of neonatal ill health and encephalopa-
determining any respiratory component to the thy.58
acidosis. There is some interest in lactate as a more Overall there would appear to be considerable
direct measure of hypoxaemic stress.60 variance on the best way of using cord blood gas
analysis, which has limitations as an independent
marker of severe perinatal hypoxia. It is thus
Cord artery pH in babies with 1 minute Apgar < 4 at perilous to extrapolate values into a diagnosis of
birth perinatal hypoxaemia or make any judgement on
25
long-term outcome without other supportive evi-
dence.
Number of babies
20
15
The pros.
10 Despite the restrictions on the method, cord blood
5
gas analysis does have merits. Measuring cord
gases soon after birth provides some indication of
0 the metabolic state of the baby. The presence
< 7.00 7.00-7.20 > 7.20 No value
Arterial pH
of significant acidosis may support a diagnosis
of severe intrapartum hypoxia and may aid in
1 Minute Apgar score for babies with arterial cord ascribing a cause to any subsequent neurological
pH <= 7.00 sequelae. A normal gas may facilitate a defence of
25
obstetric practice.
Number of babies
degree of resuscitation required49 and markers of of severe hypoxia may have cord blood values in
neonatal encephalopathy.58 the non-pathological range e which might indicate
There is evidence that the clinical progress of a genesis for the problem not related to intra-
the infant following resuscitation better informs partum events.
predictions of outcome.51 The cord pH neverthe- Used appropriately the technique has a place in
less sets a baseline against which subsequent the risk management of resuscitation and may be
measurements of blood gas parameters can be useful in any analysis of events for audit, or other
compared. When these correct rapidly, the impli- more adversarial purposes.
cation might be of a relatively minor stress and
a good outcome, as opposed to those where there Overall summary
is considerable delay in correction of any acidosis
e implying a more sustained insult.50 The processes involved in managing the risks in
respect to resuscitation are no different to those
Conclusion of any other domain. However, they highlight the
multifaceted nature of the activity, which requires
On their own, cord gases cannot be used reliably to a structured approach encompassing many differ-
predict any subsequent adverse event, particularly ent areas, and input from professionals in many
in an infant who appears otherwise well where the fields. The cost in human and fiscal terms of
available evidence suggests poor values do not a poorly carried out resuscitation is potentially
necessarily correlate with any compromised long- very high and thus it is an area that deserves close
term outcome. attention.
To be of value, whatever cord variables are
collected must be recorded along with all relevant
antenatal information pertaining to the labour and References
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