Clinical risk management at the Bambino Gesù Children's Hospital

DEVELOPMENTAL FOLLOW-UP AND OUTCOMES FOR PREMATURE INFANTS – IMMUNOLOGY

Clinical risk management atthe Bambino Gesu Children’sHospitalNatalia Bianchi

Giovanna Carta

Tommaso Renzetti

AbstractThe Bambino Gesu Children’s Hospital (OPBG), on the path of continuous

improvement of quality (for the Managed Care Query Application [MCQA]),

resulting in Joint Commission International Accreditation for excellence in

MC Clinical Management Quality Assurance, has developed a Program for

Corporate MCQA with a section devoted to clinical risk and its manage-

ment. The principles guiding the OPBG in its management of conscious

and shared risk are that safety needs to be put first, and that correcting

the organisational system is much more important and effective than pun-

ishing individuals. The aims of the programme are to encourage the

development of a culture of safety with the adoption of safe practices,

and to improve the level of paediatric patient safety. The areas of initia-

tive for improving patient safety were: training; procedures to improve

management in patient safety; the reporting of adverse events; root

cause analysis; and the 5 Million Lives campaign. The data collected

allow us to assess the degree of adherence to recommended behaviour

in order to reduce the number of adverse events occurring at the hospital.

The most effective strategy to improve patient safety must combine coor-

dinated actions and the systematic development of a true culture of

safety.

Keywords adverse events; continuous improvement of quality (MCQA);

cultural change; patient

The management of adverse events is one of the most important

aspects of improvement projects within an organisation, espe-

cially in the area of healthcare. The citizen, as a user of a health

facility, has the right to expect a system in which the organisa-

tional structure and professional competence of the personnel

permit allow risks to be evaluated and controlled and the

possibility of errors in performance, clinical management plans

or welfare minimised. Improving the safety level of care requires

a real change in our culture: errors should not be concealed

but identified, analysed and interpreted in order to improve

Natalia Bianchi MA Nursing Science is Nursing Service Coordinator at the

Bambino Gesu Children’s Hospital, Rome, Italy.

Giovanna Carta MA Nursing Science is Nursing Service Director at the

Bambino Gesu Children’s Hospital Rome, Italy.

Tommaso Renzetti RN is Nursing Service Nurse at the Bambino Gesu

Children’s Hospital, Rome, Italy.

PAEDIATRICS AND CHILD HEALTH 19:S2 S176

a particular system, rather than those who generated the error

being blamed.

The UK National Health Service (NHS) Clinical Governance

Support Team, in the document A vision of high quality care

2004, emphasises the characteristics of the overall system of

quality management in the health services. The Bambino Gesu

Children’s Hospital (OPBG) in 2006, under the path of contin-

uous improvement of quality, which resulted in Accreditation for

Excellence by the American Joint Commission International, has

set up a Program for Management for Continuous Improvement

of Quality Assistance. This was also identified as a specific plan

for the management of clinical risk, inspired by the programme

Seven Steps to Patient Safety sponsored by the National Patient

Safety Agency of the NHS, whose seven principles are listed

below:

1. The health needs of patients are the focus of all attention.

2. Information concerning the quality of services provided is

available to professionals, patients and the public.

3. Differences in access to benefits, in care processes and in

clinical results obtained are measured, and there is an

ongoing effort to reduce them.

4. All sections of the system contribute to the quality of the

services provided and their continuous improvement.

5. Professionals work in teams to attain even better perfor-

mance in terms of clinical results and safety.

6. The risks and dangers to patients are brought to the lowest

possible level.

7. Healthcare is based on evidence of efficacy and good clinical

practice.

Certain lines of action were thus identified and gradually

carried out, aiming to create and disseminate a culture of shared

security, which has translated into general operational lines to

improve the quality of care. The two principles that have guided

the OPBG in recent years to govern and operate within the scope

of known an shared risk are:

1. Patient safety should be the first and foremost goal of any

health facility: safety first;

2. In most cases, errors related to treatment are due to defects

in the system rather than to the fault of individual operatives:

correcting the system is much more important and effective

than punishing individuals.

Pursuing this ambitious goal requires not only a major

organisational change, but also and above all a profound cultural

change on the part of all players in the system. The objective of

the programme was to promote the development of a culture

of security within the entire healthcare system within the adop-

tion of safe practices, according to guidelines, best practices and

the medicand nursing records in use, in order to improve the

level of paediatric patient safety.

Materials and methods

In February 2007, a survey was carried out to investigate nurses’

degree of knowledge and awareness of the issue of errors in

healthcare. The survey was carried out by means of an anony-

mous questionnaire, distributed to 25% of the nursing staff in the

organisation, and consisting of 20 questions divided into two

parts. The first part related to personal data, education and

professional training, and the second part concerned knowledge

� 2009 Elsevier Ltd. All rights reserved.

Figure 1 The Time Out process.


about clinical risk in general, in particular about the knowledge

and application of procedures concerning the supervision and

management of adverse events and the avoidance of such events.

Many steps have been taken towards disseminating and

implementing a programme of continuous improvement in

patient safety. These include:

� training;

� procedures aimed at improving management in patient safety;

� reporting of adverse events;

� root cause analysis (RCA);

� the 5 Million Lives campaign;

� monthly conferences for the shared analysis of mortality and

morbidity.

Major procedures implemented to ensure patient safety

Risk management for the security of the patient during

surgery in the operating room

Activity in the operating room is characterised by the interaction

of a number of factors: the structure, resource technology and

professionals (nurses, surgeons, anaesthetists and support

personnel). These components are closely interdependent, and in

this regard it is necessary to ensure the proper management of

the suboperatives to promote maximum synergy. An environ-

ment is as complex as its technical aspects; both organisation and

technology are characterised by several critical points that can, in

certain situations, pose risks to the patient or the member of

staff. The operating room has been reported in the literature (UK

Public Hospitals Insurance Pool) to be among the main places

where adverse events occur.

The reports of sentinel or unexpected events issued by the Joint

Commission on Accreditation of Health Care Organizations

(JCAHO) are a source of documentation for healthcare facilities,

containing important considerations for the analysis of accidents,

and are used as a reference for risk prevention. The sentinel events

reported by JCAHO in the operating room include the following:

� operating complications;

� postoperative complications;

� errors in the administration of drugs;

� surgery to the wrong side of the body;

� transfusion error;

� damage from equipment;

� damage caused by anaesthesia;

� death resulting from complications of being on an automatic

respirator.

This shows that safety in operating rooms must be promoted

through an awareness of the problems on the part of all staff. Only

a systemic approach to risk management can achieve concrete

results sustained over time. In this way, security is guaranteed by

all the decisions, procedures and behaviours designed to identify

and eliminate, or at least reduce, the sources of risk to the patient.

To this end, certain procedures were developed and dissem-

inated at the OPBG, greatly assisted by the professionalism of the

operating room, in order to improve management in patient

safety in this area these procedures are discussed below.

Procedure for risk reduction in the operating room: a major

innovation was the introduction of the procedure for risk

reduction in the operating roomTime Out process (Figure 1),


whereby, after the first induction of anaesthesia, the entire

operating team takes a pause and verifies:

� the identity of the patient;

� the type of intervention;

� the side of the body on which the intervention is to take place;

� that informed consent has been gained;

� the daily checklist of operating room equipment and medicines.

Procedure for regulations in the operating room: these set out

the rules of behaviour to be adopted by all health care workers in

the operative room (OR).

Procedure for counting surgical instruments, needles, blades

and gauze: before the surgical intervention takes place, the

instrument nurse must verify the gauge of the needles and confirm

the sharps and surgical instruments that will be used during the

intervention, indicating the number on the nursing records. If,

during the course of the intervention, more gauze, needles,

surgical instruments and/or sharps are used, the number of these

must be added to the previous total recorded on the form.

At the end of the intervention, the instrument nurse must

identify the gauzes, surgical instruments, needles and cutters,

and check that their numbers equal the total of those used and

annotated on the form. This confirmation must be immediately

reported to the surgeon and anaesthetist, and if the totals do not

match, a reassessment will take place. At the end of the proce-

dure, the relevant nursing staff complete the second part of the

verification form, showing the materials used. Once the surgeon

has had confirmation that everything has been accounted for, he

or she can complete the operation.

Procedure for preparation of the patient for surgery: the nurse in

the operating theatre positions the patient for surgery on the basis

of the requirements and suggestions of the medical team. He or she

then fills out the checklist for preparation of the patient according

to the appropriate nursing documentation and accompanies the

patient, with the clinical file, at the sub-operative.

The operating theatre nurse accepts the patient and verifies

the proper preparation for care and requested by the surgeon

performing the intervention and indicated by the operator. If the

patient has been incorrectly prepared the nurse notifies the non

compliance to the ward where the patient came from, the anes-

thetist and the operating surgeon.

Procedure for correct identification of the patient: correct

identification of the patient is a requirement in accordance with



the International Goals for Patient Safety, whose implementation

became mandatory on January 1, 2008 in all organisations

accredited by Joint Commission International, based on Stan-

dards for Hospitals. The purpose of these goals is to promote

specific improvements in patient safety by describing solutions

based on evidence and on the consensus of experts in the field

related to certain problem areas in health.

Misidentification of the patient can in fact occur at all stages of

diagnosis and treatment, and our procedure has been developed

to improve the process of identification. In particular, this relates

to processes used to identify the patient during the administra-

tion of medications, blood and blood components, when taking

blood or other biological samples for clinical tests and when

performing other treatments or procedures.

There are two parts to patient identification: a bracelet containing

the barcode identification of the patient, including first and last

name, date of birth, ID number and hospital number, that is

compared with the barcodeattached to thepatient’smedical records.

Procedure for preparation and restocking the operating room:

before the operating room is set up, the instrument nurse checks

the drugs and principal instruments necessary for anaesthesia, as

well as the proper functioning of electrical equipment as shown

in the manufacturers’ manuals, noting the results on the oper-

ating room’s daily checklist. If there is a shortage of materials or

equipment is not functioning, the person who carried out the

verification must immediately take appropriate measures.

Management of drugs

Errors related to the management of the therapeutic process are

a major source ofharmtopatients. In the USA, 770000 people a year

suffer damage from drugs. The average cost of such damage for

each hospital is US$5.6 million, the national cost being between

US$1.56 and US$5.6 billion per year. Patients who suffer harm from

drugs also incur 8e12 additional days of hospitalisation, amounting

to a cost of US$16 000e24 000. The incidence of such adverse effects

in hospitals ranges from 2% to 7% of all admissions, and 28e95%

of this damage could be prevented by reducing errors through

appropriate control systems. Out of 200 sentinel events identified by

the JCAHO, the majority are related to drugs.

The treatment chain consists of six key moments: prescription,

identification and preparation of the drug, patient identification,

administration and proper recruitment. An error can intervene at

any stage of the therapeutic process. Current law assigns respon-

sibility to the doctor in terms of prescribing therapy, while the

nurse must ensure the correct application of the diagnostic and

therapeutic decision (DM 14/09/1994 No 739, art. 1e3).

Integrated therapy: integrated therapy is an effective solution

that acts constantly to reduce and prevent human error without

the use of advanced technologies, helps to prevent transcription

errors and contains all the relevant information concerning the

patient and the therapeutic process (date, unit of hospitalisation,

patient’s unique identification number, drug dose and number,

time, route and mode of administration).

Procedure for the management of medicines: this embraces the

whole systemand all the processes used toensure that the rightdrug

reaches the right patient under the best conditions (selection,


procurement, storage, prescription/request, distribution, prepara-

tion, dispensing, administration, documentation and monitoring).

Procedure for managing concentrated electrolyte solutions:

improving the safety of drugs carrying a high risk is the third of

the International Goals for Patient Safety, and the OPBG employs

here a procedure developed by the Health Directorate in collab-

oration with the Pharmacy Service. This procedure provides for

the identification of areas where the presence of concentrated

electrolyte solutions is clinically necessary, and appropriate

labelling and storage in these areas has been designed so as to

limit access to these solutions and prevent their inadvertent

administration.

Procedure for proper modes of communication: improving the

effectiveness of communication is the second of the International

Goals for Patient Safety. Effective communication is communi-

cation that is timely, accurate, comprehensive, unambiguous and

interpreted correctly by the recipient, and which reduces errors

and improves patient safety. The communication may be in

electronic, verbal or written form. Communications that are

more prone to the possibility of error are the requirements for

patient care given verbally in an emergency situation and the

results of examinations communicated by telephone, which may

have critical consequences for the patient.

Reporting and reporting adverse events

Procedure for the management of adverse events and events

avoided, and root cause analysis: since 2006, it has been

obligatory to report both adverse events and events avoided

(‘near misses’). At the OPBG, a multiprofessional team has the

task of evaluating the records and, for the most significant of

these, conducting a deeper analysis using RCA. This is a tool for

improving the quality of care management that aims to identify

the causes of and factors contributing to the occurrence of an

adverse event, and to outline possible improvements.

The RCA is a retrospective analysis of the event, which has to

determine:

� what happened;

� why it happened;

� what can be done to reduce the chances of the event

happening again.

At the OPBG, the following five categories of sentinel event

reported in the procedure for monitoring and managing adverse

events and events avoided are considered eligible for RCA:

1. deaths, including deaths during or after surgery;

2. errors in the prescription or administration of drugs that

have the potential, if not recognised in time, to lead to death

or serious injury, or irreversible damage to organ systems;

3. adverse reactions to drugs that have caused death or

permanent disability;

4. reactions arising from transfusion errors that have the

potential to cause death or serious irreversible damage to

organs or systems;

5. accidents during anaesthesia that can determine outcomes in

terms of mortality or morbidity.

The decision to implement RCA is determined by the level of

clinical severity of the event. The ultimate success of any RCA

process depends on the actions undertaken by the organisation in



response to the group’s recommendations. A special report is

circulated on a quarterly basis to all departments and units in the

OPBG, giving a summary of data from these recorded events,

including their distribution and type.

Safe practices to ensure patient safety

Participation in the 5 Million Lives campaign, sponsored by

the Institute for Healthcare Improvement (IHI), promotes the

adoption of a set of defined safe practices to improve the

systematic safety of care through preventing accidents related to

health activities. In particular, the IHI has sought the active

involvement of the highest possible number of hospitals, on an

international level, and proposes to accompany them on this

path with a set of training tools for both operational and moni-

toring procedures. Joining the campaign implies a commitment

on the part of the healthcare institution to follow the recom-

mended safe practices and to measure the results achieved.

The OPBG, joining the campaign, decided to adopt the

following safe practices and monitor their results:

� Prevention of infections in surgical wounds.

� Prevention of infections from central venous catheters.

� Prevent of pneumonia associated with mechanical

ventilation.

� Prevention of adverse events related to the use of drugs.

� Prevention of pressure ulcers.

� Reduce meticillin-resistant Staphylococcus aureus infections.

The efficacy of the campaign is monitored by comparing the

number of cards giving recommendations on safe practices that

have been completed and attached to patients’ medical records

with the number of procedures performed.

Conferences on the shared analysis of morbidity and mortality

Since 2004, a conference has been organised every month that

is open to all doctors at the OPBG and is coordinated on

a rotating basis by the managers of the different departments.

During these conferences, clinical cases are presented and

discussions take place on whose management has presented no

critical expectations and potentially preventable errors. One

significant result of these conferences has been the spread of

awareness that error is an eventuality in practice and that

sharing the organisational and behavioural signs will ensure

that such errors are not repeated.

Since 2008, the nursing staff has the opportunity in these

conferences to discuss their mistakes with their peers to get

a clear comparison of their experiences, with the aim of growing

professionally and ensuring safer care.

Results

All the areas described above are related to the implementation of

projects concerning risk management at the OPBG. Some of these

projects will be the subject of future publications describing data

from surveys carried out before and after their implementation.

Here we analyse the knowledge of the nursing staff at the

OPBG about the clinical risk related to these initiatives. The

tables below give some of the most significant questions that

clarify the position, views and opinions of the respondents

concerning the occurrence of errors in healthcare.


Have you ever heard about errors that

include administering, preparing or

prescribing the wrong medication?

Total %

a) Yes 163 94.2%

b) No 11 6.4%

� 2009 E
lsevier Ltd. All ri
The vast majority of nurses interviewed were aware of this

error in healthcare.

If so in what way? Total %

a) Experience 80 46.2%

b) Co-workers 112 64.7%

c) Mass media 110 63.6%

The figure shows that the most frequent sources of information

were represented by colleagues and the mass media.

What in your view, is the area where error

is most likely?

Total %

a) Preparing and administering medications 170 98.3%

b) Intensive care unit 2 1.2%

c) Emergency department 7 4.0%

For this question, the answers were classified by grouping similar

responses. Almost all of those interviewed agreed that the

preparation and administration of drugs was the area where error

was most likely.

In your opinion, what is the frequency of

these errors?

Total %

a) Low 105 60.7%

b) Medium 64 37.0%

c) High 5 2.9%

Unlike similar surveys conducted in other Italian hospitals,

reality presents a different picture of the frequency of error: while

60.7% of respondents thought that errors were uncommon, the

actual figures are more pessimistic.

In your opinion, who is responsible for most errors? Total %

a) Nurses 149 86.1%

b) Doctors 117 67.6%

c) Other operatives 11 6.4%

For this question, half of the respondents (52%) gave

a twofold response, identifying the doctor and nurse as being

jointly responsible, unlike in other Italian surveys, where nurses

ghts reserved.


have considered doctors to be almost exclusively responsible for

the errors committed.

What are these errors primarily due to? Total %

a) Incompetence 24 13.9%

b) Organisational defect 103 59.5%

c) Operatives’ stress 116 67.1%

d) Inattention and carelessness 53 30.6%

e) Badly written instructions 14 8.1%

f) Chaos in the care unit 12 6.9%

g) Double shifts 15 8.7%

h) heavy workload 44 25.4%

PAE

In your opinion, what could

be the reasons for not

reporting mistakes?

a) Afraid of being laughed

at and judged

b) It is not important to report

errors that have been intercepted

d) Insecurity and doubt about

whether such errors should be

considered to be clinical errors

e) The forms for reporting are complex

f) Afraid of being laughed at and

judged professionally incompetent

g) Involvement of other persons,

especially if acquaintances

h) Doubts about the responsibility

of who is responsible for reporting errors

i) Fear of incurring legal sanctions

DIATRICS AND CHILD HEALTH 19:S2

Total

20

22

26

8

117

78

41

19

The greatest percentage e67.1% e attributed most of the

errors to nurses’ stress, followed by defects in the

organisation.

Have you heard of clinical risk? Total %

a) Yes 163 94.2%

b) No 11 6.4%

A total of 94.2% claimed to have heard of clinical risk.

%

11.6%

12.7%

15.0%

4.6%

67.6%

45.1%

23.7%

11.0%

The data show that there needs to be a cultural change so that the

possible error in practice is no longer seen in terms of attributing

blame or derision (67.6%), but becomes an opportunity to

improve the quality of care given to patients.

The second reason highlighted (45.1%) is the fear of

involving other people, especially if they are friends. This aspect

is reflected in a review of international literature on clinical risks

and errors in health, published by Sole 24 Ore Health,

21.11.2006, which emphasises that nurses are already more

inclined than doctors to report incidents, mostly on an informal

basis.

S180

Verbal reporting occurs in 60% of cases, although a formal

report was made for only 45% of errors caused by nurses

themselves. This means that many errors (especially those that

depend on teamwork) were not reported. In fact, according to

this study, nurses themselves say they are reluctant to report

mistakes made by other team members.

Conclusion

There is no current study showing healthcare assistance that is

delivered without error. In most cases, errors are caused by

a defective system rather than being the responsibility of indi-

vidual operatives.

The myth of perfection is false as avoiding mistakes is not the

sole responsibility of individuals, so too is the myth of punish-

ment as punishing those who commit errors cannot guarantee

that they will commit fewer errors. A cultural change is essential;

we must get used to acknowledging errors and learning from

them.

We work at OPBG to spread the culture of learning from our

errors and to follow Florence Nightingale’s ideas as put forward

more than 100 years ago: ‘It may seem a strange principle to be

expressed, yet the first requirement of a Hospital lies in avoiding

damage to the sick.’

Conflict of interest

None of the authors of this paper has a financial or personal

relationship with people or organisations that could inappro-

priately influence or bias the content of the paper. A

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