An Observational Study to Improve the Surgical Safety Checklist

Viability

V. Estima

, A. Castro

, P. Gomes

, V. Nunes

and D. Pereira

3,5

Instituto Superior de Engenharia do Porto, Instituto Politécnico do Porto, Porto, Portugal

Faculdade de Engenharia, Universidade do Porto, Porto, Portugal

Instituto de Telecomunicações, Universidade do Porto, Porto, Portugal

Hospital Prof. Doutor Fernando Fonseca, EPE, Amadora, Portugal

Faculdade de Medicina, Universidade do Porto, Porto, Portugal

Keywords:

Surgical Safety Checklist, Evaluation and Use of Healthcare IT, Electronic Health Records and Standards,

e-Health.

Abstract:

To improve safety, and to reduce the mortality and complication rates during surgeries, the World Health

Organization developed the Surgical Safety Checklist (SSC). The SSC has been recently implemented in

Portuguese hospitals and we have performed an observational study where several health professionals were

observed during their normal surgical routine and interviewed. The objective of this study was to understand

the current use of the SSC, and how it may be improved in terms of usability, taking advantage of current

technological advancements. During two days, in a public health center in Portugal, a clinical team (surgeons,

anesthesiologists and nurses) was observed in 14 surgeries. Some observations disclose that several health

professionals are not familiarized with the SSC guidelines, which demonstrates that it is urgent to change the

mindset of health professionals, and that the addition of some features in the SSC may be necessary. With the

results of the observational study, we have designed and developed a web application for the SSC with new

functionalities to improve and aid the health professionals in its use.

1 INTRODUCTION

The Surgical Safety Checklist (SSC) is a support of

information that helps humans to reduce mistakes,

compensating for the possible limits in his memory

and attention. In other words, the checklist guaran-

tees consistency and entirety in the realization of a

task (Emerton et al., 2009). The use of checklists is

broad in ﬁelds such as aviation, and more recently in

clinical settings.

The concept of a checklist was ﬁrst introduced by

the administration and engineers of the Boeing Cor-

poration, in sequence of the prototype B-17 accident

(1935) in the ﬁeld of Wright, in Dayton, Ohio, killing

two pilots. The investigation showed that the plane

did not present any mechanical problem, and that the

accident was caused by human error. The Boeing

Corporation confronted with this problem, developed

and implemented a checklist, and the B-17 aeroplane

ﬂew more 1.8 million miles without further incidents

(Downey, 2010),(Schamel, 2012). It is estimated that

surgeries on the wrong body part, and to the wrong

patient take place in around 1 in each 50000 to 100000

proceedings in the United States of America (USA),

representing 1500 to 2500 adverse events of this type

yearly (Kwaan et al., 2006).

Between 2007 and 2008, inspired by the aviation,

the World Health Organization (WHO), identifying a

problem with surgical complications and errors, cre-

ated the programme “Safe Surgery Saves Lives” to

improve the surgical safety and to reduce the num-

ber of deaths and surgical complications. Within

this programme the WHO developed the SSC, and

it was tested between October 2007 to September

2008‚ in a multicentric study (8 hospitals in 8 differ-

ent cities: Toronto‚ Nova Deli‚ Amman‚ Auckland‚

Manila‚ Ifakara‚ London and Seattle). After the intro-

duction of the checklist, the incidence of patient com-

plication lowered from 11.0% to 7.0% (P<0.001),

and the rate of death declined from 1.5% to 0.8%

(P = 0.003) in all institutions (Haynes et al., 2009).

In a different study, it was observed that after

390

Estima V., Castro A., Gomes P., Nunes V. and Pereira D..

An Observational Study to Improve the Surgical Safety Checklist Viability.

DOI: 10.5220/0005215303900396

In Proceedings of the International Conference on Health Informatics (HEALTHINF-2015), pages 390-396

ISBN: 978-989-758-068-0

 2015 SCITEPRESS (Science and Technology Publications, Lda.)

the SSC introduction the nurses recognized that pa-

tients identity was more often conﬁrmed (81.6% to

94.2%, P<0,01), and the anesthesiologists were bet-

ter aware of available cross-matched blood and of

due checking of anesthesia equipment. This study

also stated that anesthesiologists discussed more often

the possible critical events with surgeons (of 22.0%

for 42.6%, P<0.001) after the post-operative (Takala

et al., 2011).

In June 2010, in Portugal, the “Direção-Geral da

Saúde” (DGS) in the use of the technical or normative

norms, determined the implementation of the “Safe

Surgery Saves Lives”, in all the operation rooms (OR)

of the National Health System until the end of the

September 2010 (George, 2010). In 2011 the im-

pact of the SSC in 5 Portuguese hospitals was stud-

ied. The authors observed, after interviewing 153

health professionals, that 41.6% did not know the

SSC. Another interesting result is that before Septem-

ber 2010 (mandatory adhesion by all the OR to the

SSC) just one hospital had implemented the SSC

(Valido, 2011). In June 2013, a circular normative

has been issued reinforcing the mandatory implemen-

tation of the project “Safe Surgery Saves Lives” in ac-

cordance with the “Implementation manual - Surgical

Safety Checklist” (George, 2013).

Knowing this, there is a need to understand the

workﬂow of the SSC in Portuguese hospitals and the

difﬁculties felt by the users. All due to the importance

of patient safety, since that surgical procedures are an

integrant part of healthcare systems all over the world.

1.1 The Surgical Safety Checklist (SSC)

The Surgical Safety Checklist (SSC) divides the

surgery in three phases, each one corresponding to a

speciﬁc period in the normal ﬂow of the surgery: the

period before induction of anesthesia; the period after

induction and before skin incision; and the period dur-

ing or immediately after the wound close, but before

patient leaves the room. To ensure the fulﬁlment of

the SSC one person should be designated to verbally

check all the steps and actions with the team, usually

the circulating nurse but it may be any element of the

team, by the checklist coordinator.

In the ﬁrst phase (before induction of anesthesia)‚

at least one nurse and one anesthesiologist must be

present. In the second (before skin incision) and third

(before patient leaves operating room) phases all the

participants should be present, nurses, anesthesiolo-

gists and surgeons.

2 OBSERVATIONAL STUDY AND

INTERVIEWS

METHODOLOGY

This observational study was performed at public

health center in Portugal, after institutional approval.

During two days the clinical team in one of the hospi-

tal’s operating rooms (OR) was observed during their

standard clinical practice. This observational study

encompassed 14 surgeries, and the clinical team was

not aware of the true intent of the observer. After the

observational study a set of questions were made to

the intervenients and other related professionals.

2.1 Observational Study

The observations aimed to understand the functioning

of the SSC in the OR during the standard clinical rou-

tine, and observe how the different health profession-

als were involved in this task, surgeons, anesthesiolo-

gists and nurses. In this study, the observer degree of

involvement and relation to the observed was consid-

ered to be passive. He was not directly involved in the

situation that was observed, meaning, the observer did

not interact, neither intentionally affected the object

of observation (bystander). In addition, the partici-

pants did not knew the objective of this observational

study. The observer focused on the same points of

interest in all interventions:

• At what surgery stage is recorded each SSC phase;

• Which health professionals register each checklist

phase;

• Are all items of the SSC read out loud;

• Are there items of the checklist said out loud that

are not registered immediately after.

This information was registered throughout the

surgical interventions.

2.2 Interviews

After the observational study, the researcher con-

ducted the interviews to these professionals, using a

semi-structured approach. One of the objectives of

the semi-structured interviews was to know the opin-

ion of health professionals on the use and utility of

the SSC. The respondents were surgeons, anesthesi-

ologists and nurses in the same OR of the observa-

tional study. The semi-structured interviews followed

a previously prepared questionnaire that served as a

guideline, with no strict order of questions, manag-

ing to adapt the development of the interview to the

respondent, ensuring that participants responded to

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these same questions outlined, but with a high degree

of ﬂexibility depending on the answers given. The

guideline was as follows:

• What is your profession?

• Is the SSC used in the operating rooms of your

hospital according to the rules explained in the

WHO manual:

– Each item of SSC is validated at the time that

statement is read?

– How is the validation performed (item by item,

phase by phase, all at once)?

– All questions are listed in the predetermined or-

der?

• In your opinion, are all the questions correctly for-

mulated?

• Did the checklist change the way you work?

• In your opinion, what are the beneﬁts and disad-

vantages of implementing the checklist, deﬁned

by WHO / DGS in 2010?

• In your opinion, would it be advantageous to

adapt the checklist to each type of surgery?

• In your opinion, would it be advantageous to use

a Tablet / Smartphone for implementing the SSC?

In addition of the health professionals, the IT pro-

fessionals of the hospital were also interviewed. The

semi-structure guideline of the interviews followed

the same rules of the script for the health profession-

als. The questions were as follows:

• In your opinion, would it be advantageous to

adapt the SSC to each type of surgery?

• In your opinion, would it be advantageous to use

a Tablet/Smartphone for implementing the SSC?

• Do external application may be added into the

hospital software?

The answers to the questions made were not

recorded by any kind of device, we just took notes

during an interview, compiling them right after.

3 RESULTS

The clinical setting observed was one of the opera-

tion rooms (OR) of the 11 available at the hospital.

Surgical interventions in this hospital cover several

medical specialties such as General Surgery, Orthope-

dics and Traumatology, Gynecology, Urology, Pedi-

atric Surgery, Otorhinolaryngology, Ophthalmology,

Plastic Surgery and Maxillofacial Surgery.

Figure 1 presents an overview of the OR were the

observational study took place. It is possible to see the

Figure 1: Operating Room (view from the top): 1. anesthe-

sia material and equipment cabinet; 2. surgical and anaes-

thesia equipment/material trolleys; 3. refrigerator with ma-

terial; 4. trash cans; 5. stools; 6. chair; 7. computers;

8. white board, and x-ray light; 9. surgical equipment; 10.

ventilator and anaesthesia monitors; 11. surgery lights; 12.

operating table; 13. sterilization room.

setting organization, and display of the material in the

available space, including the material trays, anesthe-

sia monitors and ventilator, operating table and sup-

port tables.

Figure 2 presents the action zones for each actor

inside the OR. This observation can help us to under-

stand why and how each actor interacts with the SSC

and if we can adjust the guidelines to their current

methodology.

Figure 2: Zones of action inside the Operating Room (view

from the top) for each actor.

3.1 Observation

On the ﬁrst day, the study was performed during the

morning period, from 10:30 am to 2:30 pm, and af-

ternoon period, from 3:30 to 9:30 pm. The observer

was present in 4 surgeries through the entire process

of the Surgical Safety Checklist (SSC), and in 4 surg-

eries for some of the parts of the procedure. On the

second day, during the afternoon period, from 04:00

pm to 8:30 pm, the observer was present in 6 surgeries

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Table 1: Observations to the Surgical Safety Checklist usage in the operating room at a public health center. In this table

we can see, for each surgery, what stages of the Surgical Safety Checklist where properly done and what was not done in

accordance with the guidelines.

Surgery ID

Items with-

out immediate

registration

1st and 8th _______ During surgery During surgery

Before patient

leaves operating

room

Circulant Nurse or Circulant and In-

strumentalist Nurse

Only the items that were unknown

to the user or no item

2nd Sign In Anaesthesia

When anaesthe-

sia

Before patient

leaves operating

room

Circulant Nurse and Surgeon in

Sign Out

Only Sign Out

3rd, 6th and

9th

4th, 5th,

7th, 10th

and 11th

Before patient

leaves operating

room

Before patient

leaves operating

room

Before patient

leaves operating

room

Circulant and Instrumentalist Nurse

or Anaesthetist Nurse

No item or Anticipated blood

loss and completion of instrument,

sponge and needle counts

12th Sign In, Time Out During surgery During surgery

Before patient

leaves operating

room

Circulant Nurse Time Out and Sign Out

13th

and14th

_______

Before induction

of anaesthesia

Before skin inci-

sion

Before patient

leaves operating

room

Circulant Nurse All itens

Table 2: Pros and cons retrieved from the interviews to the health professional (surgeons, anesthesiologists and nurses) about

the Surgical Safety Checklist use.

Nurses

Pros

"The use of the checklist is important and should be enforced properly"

"If the checklist was a team work, this time would not be a waste, and its use would be improved"

The adaptation of the checklist to the type of surgery would be a good solution

Cons

At the beginning of the implementation of the checklist, professionals complied with the rules of the

user manual, but due to the attitudes of some surgeons they have stopped doing it

The collaboration of surgeons is scarce

The registration of the checklist in the hospital software is done by these professionals, their names can

be held liable if an incident occurs

The use of a mobile application would not improve the functioning of the checklist

Anesthesiologists

Pros

"The use of the checklist is important and should be enforced properly"

The adaptation of the checklist to the type of surgery would be a good solution

Cons

The use of a mobile application would not improve the functioning of the checklist

The checklist is not used properly because no one is blamed if an incident occurs due to lack of data

completion

Surgeons

Pros

The adaptation of the checklist to the type of surgery would be a good solution

"It is a memory aid, because we are human and we all fail"

"The ﬁrst questions should be asked before the patient is sent down to the operating room, and surgeons

should have access to them"

Cons

It is difﬁcult to apply the checklist when experienced health professionals do not set an example, espe-

cially to the younger ones

It is necessary to change minds, they are aware that many colleagues do not collaborate with the nurses

"If anyone who did not ﬁll up the checklist, or did not cooperate in their fulﬁllment was punished, it

was possible to work"

Demotivation of health professionals with the health system at the moment (possible justiﬁcation for

not completing the checklist)

"When there are new implementations, especially surgeons, are very reticent"

"It would take several serious incidents to open the minds of these professionals"

Many of the resident surgeons, do not know the function of the checklist

"There is always a way to not comply with the rules of the checklist or other computerized program"

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through the entire SSC process. Table 1 summarizes

the observed procedures regarding the checklist use in

the two days.

In the two days of the observation, and of the 14

observed surgeries, only 2 surgeries met the require-

ments for the three phases of the SSC, as deﬁned by

the WHO. Of the remaining 12 observed surgeries, 9

surgeries completed the last phase at the correct time.

The SSC was always ﬁlled by any of the nurses that

were available, except for a surgery in which a sur-

geon helped the nurses to ﬁll one of the last phases.

It was also observed that only in 2 surgeries all

the phases of the SSC were read aloud to the team.

In the remaining surgeries, in 4 of them some of the

phases were read aloud and in 8 of them none of the

phases were read aloud to the team. We also observed

that, in 7 surgeries, several items were read aloud and

answered but no one was checking the SSC, only after

the end of the phase.

3.2 Interviews

I the end of the two days, several health professionals

and technicians (surgeons, circulating nurses, anes-

thesiologists and IT) were interviewed by the same

observer. Their opinions are presented in Table 2.

In general, the circulating nurses have the opinion

that the use of the SSC is very important, but reported

that not all health professionals involved collaborate

the same way. When the SSC became mandatory they

tried to follow with all the rules of the World Health

Organization (WHO), but due to lack of cooperation

of the surgical team, they decided to stop asking a few

items aloud, stating: “if the SSC was a team work, this

time would not be a waste, and its use would be im-

proved”. In their opinion, a mobile application would

not help to improve the functioning of the SSC. They

consider that the SSC could be adapted to each type

of surgery, for example, they consider that the iden-

tiﬁcation of all team members by name and role, in

most of the Portuguese hospitals would be unneces-

sary, because usually the teams are known to each

other. Other example is the different materials used,

depending on the type of surgery that the SSC request

to conﬁrm in the last phase.

The anesthesiologists were also in favor of the

SSC and in their opinion, the main reason for the low

commitment to not follow the rules according to the

WHO guidelines, is that nobody wants to be held re-

sponsible in case of a preventable complication: “it is

ﬁlled according to some of the rules but I admit that

not all of them, there is not a lot of rigour in its regis-

ter”. The anesthesiologists also do not ﬁnd the use of

a mobile application a surplus value for the SSC, but

quite the opposite, stating that the adaptation of the

SSC would be a good improvement.

All the surgeons that have participated in the surg-

eries(orthopedics, urology and plastic surgeons) were

interviewed, and presented very divergent opinions.

Some considered that the use of SSC is very impor-

tant for the safety of the patient, mainly in the points

of the laterality and identiﬁcation, but recognize that

many health professionals, mainly the surgeons, still

have not adapted to its use. Also, they stated that

if in the case of complications, if the SSC was used

to ﬁnd the reason of the problem, they would rapidly

change their attitude towards it. Other surgeons state

that the SSC may be important but they do not usually

do it. Actually they consider that the years of expe-

rience are more important than a single SSC. Finally,

one of the problems cited is the fact that “the register

of the SSC or any register was easier when done in

paper when compared to a computer program”. Re-

garding the mobile application, they consider it to be

useful in the conﬁrmation of the material and equip-

ment necessary for the procedures, so the nurses could

rial is stored. The SSC adaptation to different surgery

types, in their opinion, would be ideal, since they con-

sider some items superﬂuous.

The IT staff of the hospital was surprised with the

observations because they never thought that the pro-

fessional were not complying with the WHO guide-

lines. Also, they explained that it is possible to adapt

the SSC software available at the hospital to a new

application (software that may for example adapt the

SSC for each type of surgery), after approval from

“Direção-Geral da Saúde” (DGS).

4 SURGICAL SAFETY

CHECKLIST APPLICATION

PROPOSAL

After an analysis of the results obtained in the obser-

vational study, and the opinions gathered in the inter-

views, the next step of this study was the development

of a SSC application responding to the health profes-

sionals requests, that may be adapted to the type of

surgery, and easily introduced in the hospital’s sys-

tem. We have chosen an web approach due to all

the advantages of this platform (Umbach, 2004; Man-

freda et al., 2002).

In this application the user can chose between a

SSC already created to a speciﬁc surgery or to create

a new SSC, adding and adapting some questions from

the World Health Organization (WHO) standard. In

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Figure 3: Mockup layouts of the web proposal. In this mockup it is possible to see some of the improvements proposed

mainly in the third layout you can see the single question at time, the progress bar and the no go back option.

this proposal the improvements are focused in forcing

the user to focus in the workﬂow of the SSC and to

save the input timestamps and any actions made by

them. Therefore, we believe that the following fea-

tures implemented will achieve that goal (see ﬁgure

3).

• Display one item of the SSC at a time. This fea-

ture will force the user to focus on the question at

hand and will not allow the user to answer other

questions out of order;

• Display the stage where the SSC is, so the user

knows what he is doing and to help him, guiding

him through the SSC;

• Do not allow going back to the previous step. This

feature forces the user to be fully aware of his an-

swers. In this feature we will implement some

safeguards such as highlighting the answers and

only allowing keeping forward some time after the

answer is given. A go back button should be im-

plemented anyhow, but the user will be informed

that that action will be registered as a forced go

back requested by the user;

• Do not allow going forward to the next item if the

current is not ﬁlled;

• Do not allow going forward to the next item if the

time it took to ﬁll the item was too short. This

feature tries to stop random inputs to just force

the SSC to go further, or to prevent any by heart

input;

• Log any action made by the user. This feature will

allow to access if the SSC is being ﬁlled properly

according to the WHO guidelines.

5 DISCUSSION AND

CONCLUSIONS

The surgical treatment is an integrant part of health-

care systems all over the world‚ with a respected value

of 234 million fulﬁlled surgeries‚ annually (Haynes

et al., 2009). Preventable surgical complications rep-

resent a large percentage of injuries and deaths world-

wide. It is estimated that adverse events affect 3 to

16% of all hospitalized patients, 3% of those adverse

events occurring during surgery and 0.5% ending in

mortality, i.e. almost 7 million patients have signiﬁ-

cant surgical complications where each year 1 million

will die during or immediately after surgery (Kable

et al., 2002), (Gawande et al., 1999). It very impor-

tant that all health professionals comply with the rules

of the WHO manual because this numbers can be re-

duced with a simple gesture of teamwork.

The positive points of the observational study

were the full collaboration of the healthcare profes-

sionals involved, and also from the IT team of the hos-

pital. Also, observing the SSC use was of paramount

importance in the understanding of the entire process

at the operating room. It should be highlighted, that

due to the study design and speciﬁcity, data volatil-

ity may be an issue, since everything was noted down

and not recorded, and in the operating rooms several

simultaneous events were happening at the same time

which may have led to missed events.

The results of the observational study, indicate

that the SSC is not properly ﬁlled, in the majority of

times, according to the WHO guidelines. It is con-

cluded that it is urgent to change the mindset of many

health professionals, and that there is a need to raise

awareness to the SSC impact, through, for example,

interventions to various undergraduate courses related

to healthcare, or lectures from aviation profession-

als as a parallel example of the checklists successful

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395

used. We also believe that more hearings to the use of

the SSC in the hospitals or a certiﬁcation may incite

is proper use. Reported incidents may serve as exam-

ples of the SSC impact, as it happens in the aviation

(Downey, 2010).

The designed application may be integrated in the

hospitals’ systems, to control the use of the SSC, and

the new proposed features may help the SSC to be-

come more user-friendly, and reliable. This needs to

be investigated in further studies and a collaboration

with the WHO is required to validate modiﬁcations

for each type of surgery.

ACKNOWLEDGEMENTS

The authors would like to acknowledge the support

of Hospital Prof. Doutor Fernando Fonseca, EPE,

specially to all health professionals involved for their

participation, full collaboration, and insightful discus-

sions.

This work was partially funded by Project I-CITY

- ICT for Future Health/Faculdade de Engenharia

da Universidade do Porto, NORTE-07-0124-FEDER-

000068, funded by the Fundo Europeu de Desen-

volvimento Regional (FEDER) through the Programa

Operacional do Norte (ON2) and by national funds

through FCT/MEC (PIDDAC).

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