Towards better patient safety: WHO Surgical Safety Checklist in otorhinolaryngology

Authors


P. Helmiö, Department of Surgery, Turku University Hospital, P.O. Box 52, FI-20521 Turku, Finland. Tel: +358 50 382 4667; Fax: +358 2 313 2284; e-mail: pamais@utu.fi; paivi.helmio@tyks.fi

Abstract

Clin. Otolaryngol. 2011, 36, 242–247

Objectives:  The World Health Organisation has developed a Surgical Safety Checklist to improve patient safety during surgery. This checklist has reduced postoperative morbidity and mortality. Prior to checklist implementation, we wanted to evaluate how it would fit into the process of otorhinolaryngology-head and neck surgery and whether it would have an impact on the awareness of safety-related issues.

Design:  A structured questionnaire was addressed to the operating room team after consecutive operations during a 1-month period before and after checklist implementation.

Setting and participants:  This study was conducted at the Department of Otorhinolaryngology at the Helsinki University Central Hospital as a part of a multicentre study. Responses were received regarding 288 operations before and 412 after checklist implementation.

Main outcome measures:  The questions concerned patient-related safety checks, teamwork and communication.

Results:  The checklist improved verification of the patient’s identity (P < 0.001). Awareness of the patient’s medical history, medication and allergies increased (P < 0.001). Knowledge of the names and roles among the team members improved. The otolaryngologists and anaesthesiologists discussed possible critical events more often (P < 0.001), and postoperative instructions were better recorded after use of the checklist. In addition, the checklist enhanced communication between operation team members.

Conclusions:  Our study confirms that the Surgical Safety Checklist fits well into the surgical working process in otorhinolaryngology-head and neck surgery improving the sharing of patient-related medical information between team members. Development of a specific checklist for otolaryngology calls for further study.

Adverse events in surgery often result from simple human error. All types of surgeries including otolaryngology are prone to complications related to the wrong side/wrong site, wrong procedure and wrong patient (WSPE). These complications are often preventable by reducing risk for serious mistakes.1–5

The World Health Organisation (WHO) has developed a Surgical Safety Checklist to improve patient safety in the operating room. In an international multicentre study, this checklist was associated with significant reductions in complications and deaths regardless of the healthcare system or the economical setting.6

Few studies concern implementation of this checklist in various surgical surroundings, which has diminished complications in urgent surgery by more than a third.7 In paediatric surgery, it has improved teamwork and communication.8 Similarly, in a study on trauma and orthopaedic patients, team communication improved, but no significant reduction in early complication emerged.

The idea of the checklist is to be an add-on security tool for the defined safety standards. This checklist should be customised, some suggest, to meet the needs of quite different surgical specialities and institutions.8,9 Thus far, authors have failed to find published data on checklist implementation, usefulness, or impact on complications concerning otorhinolaryngology-head and neck surgery (ORL-HNS).

The aim of our study was to evaluate how this checklist would fit into the surgical working process in the ORL-HNS and whether it would improve awareness of safety-related issues.

Materials and methods

Checklist pilot project in Finland

The surgical unit of the Department of Otorhinolaryngology in Helsinki University Central Hospital (HUCH) participated in the pilot project implementing the WHO Surgical Safety Checklist in four Finnish hospitals in 2009. In addition, a multicenter study of checklist implementation took place in several surgical specialities. As part of the study, we collected data from all otolaryngological operations in HUCH during the study periods.

A group of experienced clinicians from several surgical fields evaluated the WHO checklist, translated into Finnish, with minor changes designed in collaboration with Finnish health authorities (Appendix 1). In the Sign-in check, elements added included patient’s medical condition and medication. All checklist steps and items were retained, and at this point, no specialty-related modifications made.

Questionnaire

A structured multiple-choice questionnaire was designed for the study, directed to the operating room-team members: otolaryngologists, anaesthesiologists and circulating nurses (Appendix 2). Its structure followed the WHO checklist’s three-part framework of Sign in, Time out and Sign out. Together with the existing safety checks, we asked about issues considered important such as patient’s weight and height. The answer-choices were ‘yes’, ‘no’, ‘do not know’ and ‘not relevant’. At the end of the form, one question concerned communication between team members, followed by a space for free-text comments.

To test the internal validity of the questionnaire, we also asked about issues on which the checklist should not affect, e.g. the question concerning patient’s hygiene.

Data collection

The questionnaire was introduced to the operating room personnel before the study. The questionnaire was answered during two separate periods. The first study period took place before the use of the checklist and the second period after the implementation of the checklist.

Data from the first study period were prospectively collected in May 2009. Immediately after each operation, team members answered the questionnaires independently.

Before implementation of the checklist, an outside professional (author S.-L.P.) gave a presentation about the WHO Surgical Safety Checklist, and the operating room staff heard three informative lectures on how to use it, each lasting 45 min. The circulating nurses were appointed as checklist coordinators, and specific guidelines on use of the checklist were available in the operating room. Short instructions appeared also on the back of the checklist.

The checklist was implemented for use on September 1, 2009. At the same time, data collection for the second study period began. One otolaryngologist (K.B.), one anaesthesiologist (A.T.) and two operating room nurses conducted and encouraged checklist use and questionnaire completion.

Furthermore, we evaluated the data from an operation database for specific characterisation of the operations performed during the study periods.

Statistical analyses

For statistical processing, all ‘not relevant’ values were excluded from among the definite variables (side of operation, prophylactic antibiotics and radiological images). The values of the categorical variables were further classified as ‘yes’ or ‘non-confirmed’. The ‘non-confirmed’ class included ‘no’, ‘do not know’ and missing values. Data are presented in numerical form as the proportion of ‘yes’ answers (%), unless otherwise indicated. Comparisons between before and after checklist groups were calculated by chi-square test. P-values of <0.05 were considered significant.

Statistical analyses were carried out with SAS/STAT® software, Version 9.1.3 SP3 of the SAS System for Windows (SAS Institute Inc., Cary, NC, USA).

Ethical considerations

As no patient-identifying data were used, according to Finnish legislation, no ethical approval was required.

Results

Background data

During the study periods, a total of 747 operations were recorded on the operation database, 304 before and 443 after checklist implementation. The operations covered all subgroups of ORL-HNS (Fig. 1). Characteristics of the patients and operations are presented in Table 1.

Figure 1.

 Operations performed during the study periods, before and after checklist implementation. Number (n) of operations recorded in the operation database.

Table 1.   Characteristics of patients and procedures before and after checklist implementation
 Before n (%)After n (%)
  1. ASA, American Society of Anesthesiologists; sd, standard deviation.

  2. Number (n) and proportion (%) of cases recorded to the operation database.

Total304 (100)443 (100)
Children (under age 16)73 (24.0)78 (17.6)
ASA class I–II245 (80.6)381 (86)
Outpatient procedure120 (39.5)260 (58.7)
Urgent operation53 (17.4)29 (6.5)
Local anaesthesia50 (16.4)87 (19.6)
 h:min (sd)h:min (sd)
Mean duration of anaesthesia1:23 (1:17)1:20 (1:14)
Mean duration of operation0:58 (1:07)0:55 (1:05)

Response rate and missing data

The questionnaires were returned from 700 operations, 288 (94.7%) before and 412 (93.0%) after checklist implementation. The proportion of replies to the various questions ranged from 91% to 99%. In some operations performed under local anaesthesia, an anaesthesiologist was neither present nor answered the questions.

Test questions

In replies to the questions that were testing the internal validity of the questionnaire, there were no differences between the study groups.

Safety checks

The anaesthesiologists’ awareness of the patient’s medical history, medication and allergies increased after checklist implementation. Patient’s weight and height were also better recorded. These improvements were statistically significant (Table 2). In one free-text comment on one operation, a check revealed critical information about the patient’s medical condition that led to cancellation of the operation. Additionally, in two operations, discovery that the patient had just eaten led to these operations being cancelled.

Table 2.   Anaesthesiologist’s answers concerning awareness of patient-related issues
 Before n (%)After n (%)
  1. Number (n) and proportion (%) of ‘yes’ replies before and after checklist implementation.

  2. *P-value <0.001, statistical significance for difference, calculated by the chi-square test.

Medical history200 (69.4)363 (88.1)*
Medication203 (70.5)346 (84.0)*
Allergies173 (60.1)318 (77.2)*
Weight and height231 (80.2)390 (94.7)*
Total288412

Pre-check of anaesthesia equipment increased from 70.5% to 84.0% of the operations, P < 0.001. The checklist had no effect on preparation for difficult intubation. One anaesthesiologist wrote as free text: ‘In the ENT, we are always prepared for a difficult airway’. Blood loss over 500 mL (>7 mL/kg in children) was estimated only in 2.1% of the operations before and 1.5% after checklist implementation.

The checklist improved verification of the patient’s identity by all operating room-team members. The otolaryngologists’ and anaesthesiologists’‘yes’ replies concerning awareness of the procedure increased. All team members were aware of the side of the operation more frequently, but with no statistical significance in difference (Table 3). In addition, two free-text comments concerned side: In one operation, the wrong side was written in the plan, but the skin was marked correctly. In another operation, the wrong side was written in the plan, and this was revealed in the check.

Table 3.   Operating room team members’ answers concerning awareness of patient’s identity, planned procedure and correct surgical side
 Identity of patientProcedureSide (when defined)
Before
n (%)
After
n (%)
P-value*Before
n (%)
After
n (%)
P-value*Before
n (%)
After
n (%)
P-value*
  1. NS, not significant.

  2. Number (n) and proportion (%) of ‘yes’ replies by profession before and after checklist implementation.

  3. *Statistical significance for difference, calculated by chi-square test.

Otolaryngologist206 (71.5)345 (83.7)<0.001231 (80.2)366 (88.8)0.0015175 (84.1)257 (87.7)NS
Anaesthesiologist178 (61.8)343 (83.3)<0.001223 (77.4)351 (85.2)0.0085145 (66.8)184 (74.5)NS
Circulating nurse253 (87.9)396 (96.1)<0.001276 (95.8)383 (93.0)NS210 (90.9)295 (93.7)NS

Radiological images were used in 45.1% of the operations before and 31.5% after the checklist. When needed, images were available for 85.4% of operations, with no difference occurring after use of the checklist. A minority of the patients (13.9% before and 9.5% after the checklist) received a prophylactic antibiotic, but no statistically significant improvement in timing of administration was evident (P = 0.44).

The checklist significantly improved otolaryngologists’ and anaesthesiologists’ awareness of the other operating room-team members’ names and roles. In addition, they discussed possible critical events in the operation more frequently. The postoperative instructions and prescriptions were better recorded with the checklist (Table 4).

Table 4.   Issues related to teamwork
 Knowledge of OR-team’s names and rolesRisks discussedPostoperative instructions recordedSuccessful communication
Before
n (%)
After
n (%)
P-value*Before
n (%)
After
n (%)
P-value*Before
n (%)
After
n (%)
P-value*Before
n (%)
After
n (%)
P-value*
  1. OR, operation room; NS, not significant.

  2. Number (n) and proportion (%) of ‘yes’ replies by profession, before and after the checklist implementation.

  3. *Statistical significance for difference, calculated by the chi-square test.

Otolaryngologist175 (60.8)335 (81.3)<0.00170 (24.31)151 (36.7)<0.001235 (81.6)375 (86.7)NS268 (93.1)395 (95.9)NS
Anaesthesiologist217 (75.4)360 (87.4)<0.00171 (24.7)161 (39.1)<0.001212 (73.6)351 (85.2)<0.001228 (79.2)358 (86.9)0.0064
Circulating nurse266 (92.4)388 (94.17)NS187 (64.9)374 (90.8)<0.001

Communication

The answer to the question about communication was associated with the respondent’s profession. From the otolaryngologists’ point of view, communication was successful in a majority of the operations. The anaesthesiologists and circulating nurses also reported improvement in communication after the checklist (Table 4). Before the checklist, the circulating nurses gave a considerable number (23.3%) of answers ‘not relevant’ to this question, but after the checklist, none. The anaesthesiologists’‘not relevant’ answers diminished from 7.9% to 2.0%.

Discussion

Synopsis of key findings

The WHO checklist improved recognised aspects associated with safe surgery in otolaryngology by improving verification of patient identity, and awareness of the patient’s medical condition and the side of the operation. In addition, the checklist enhanced communication between the surgical team members.

Strengths and weaknesses of the study

To our knowledge, this is the first study of its kind in otolaryngology. Our samples were relatively large and covered all subgroups of ORL-HNS surgery.

Some differences in the characteristics of the operations and patients were shown between the two study periods of 1 month each. The study groups consisted of consecutive operations and can be considered as selective convenience samples, a fact which weakens the study’s external validity.

Implementation of the checklist and concomitant answering to the questionnaire was challenging and required changes in routines. The response rate was high, and overall, the operating room personnel were supportive. Completing the questionnaire at the end of the operation can be considered a limitation. Answers might have been more precise immediately after the checks.

Comparisons with other studies

Our findings challenge the opinion of Karamchandani and McGarry10 in Clinical Otolaryngology that: ‘In ENT, we are unlikely to see immediate large benefits from the checklist because of the predominance of low mortality and low morbidity procedures. Perhaps only head and neck surgery exhibits the levels of risks that would demonstrate effect of significant size’. In fact, many adverse events are common with all kinds of surgeries, such as complications related to the WSPE. It is also known that communication breakdown is the most common cause of surgically adverse event.1–4,11

All age groups are represented in otolaryngology. The diseases are not usually associated with co-morbidities, and the operations do not cause immobilisation. The high number of outpatient surgeries, many carried out under local infiltration or regional anaesthesia, is also typical. The operations and patients in our series represented well these characteristics. One-fifth of the patients were children, and the majority of patients were in good medical condition.

Use of the checklist improved verification of patient identity, but this was still inadequate. It is absolutely essential to confirm the identity of the patient, even repeatedly. Awareness of the patient’s medical condition, medication, and even weight and height increased after checklist use. The check on weight and height was later added to the Finnish version of the checklist. In Paediatric Surgical Safety Checklist is a check on patient weight.8 Similarly, weight is relevant in otolaryngology because a substantial proportion of our patients are children.

Despite the development of preventative methods, wrong-side surgery (WSS) still occurs. A detailed review of wrong-side craniotomies describes a broad range of factors contributing to WSS, human error being the most prevalent factor. Most of these WSS could have been prevented. Bypassing preventive systems like preoperative checks and time-outs elevated the likelihood of WSS.3 Frequency of WSS is varying by surgical specialty and type of surgery.5 Wrong-side surgery has occurred in 6.1% of reported errors in otolaryngology.1 In a mail survey of otolaryngologists in North America, 9.3% of respondents knew of a case of wrong-side endoscopic sinus surgery.2

Our study revealed that awareness of side was insufficient. Some improvement occurred with the checklist, but this was not statistically significant (Table 3). However, the wrong side was written in two operation plans and was noticed when the checklist was used.

It is noteworthy that a time-out check was used in 32.4% of the wrong-site sinus surgery cases2 showing that these checks should be carried out with the utmost care. Dismissive replies, affirmative and inaccurate, are typical of a badly used checklist and poor use of a checklist will lessen its efficiency in preventing adverse events.12 In any case, the protocol of checking the side of the operation must be improved,3 and a properly used checklist is a good tool for this very important safety problem.

Communication failure is one of the leading factors contributing to surgical errors and medical adverse events, including WSPE.3,4,13 Use of standardised communication improves the information transfer process, with an effect on clinical and patient outcomes.14

Preoperative briefing has reduced communication failures.15,16 In our study, critical events were discussed more commonly between anaesthesiologists and otolaryngologists. The experience of successful communication between team members improved after checklist implementation. This has also been true in paediatric, trauma and orthopaedic series.8,17 The checklist also improved the recording of postoperative prescriptions and instructions and did not delay or prolong any operations in our series. In one study, preoperative briefing actually reduced operating room delays.15

Clinical applicability of the study

Our study confirms that the surgical checklist fits well into otolaryngology. After its introduction in 2009, several hospitals have made the checklist mandatory in Finland. We recommend the use of this checklist in all operations.

Conclusion

Our study confirms that the Surgical Safety Checklist improves the sharing of patient-related medical information, which is common for all specialities. In addition, it reduces communication failures between the team members. These improvements are key issues in patient safety.

The development of a specific checklist for ORL-HNS needs further consideration and activity by otolaryngological associations.2

Keypoints

  • • The WHO Surgical Safety Checklist improves recognized aspects associated with safe surgery in otolaryngology.
  • • The checklist improves verification of patient identity, and awareness of the patient’s medical condition and side of the operation.
  • • The checklist enhances communication between the surgical team members.
  • • A specific checklist for surgery in ORL-HNS needs further consideration.

Acknowledgements

The authors thank all participants in the checklist project: Riitta Aaltonen, Ari Katila, Anna Kotkansalo and Karoliina Peltomaa. We thank operating room nurses Nina Starck and Mia Suihko and are indebted to Jukka Saukkoriipi for performing the computer runs and to Tero Vahlberg for statistical consultation and to Carol Norris for linguistic revision.

Conflict of interest

None declared.

Ancillary