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ORIGINAL ARTICLE

Prevention of Surgical Malpractice Claims by Use of a Surgical


Safety Checklist
Eefje N. de Vries, MD, PhD∗ ‡, Manon P. Eikens-Jansen, MSc†, Alice M. Hamersma, MSc†,
Susanne M. Smorenburg, MD, PhD‡, Dirk J. Gouma, MD, PhD∗ , and Marja A. Boermeester, MD, PhD∗

shown that the majority of surgical errors occur outside of the oper-
Objective: To assess what proportion of surgical malpractice claims might be
ating room.7,11,12 This perception formed the basis for the SURgical
prevented by the use of a surgical safety checklist.
PAtient Safety System (SURPASS) checklist, the development of
Background: Surgical disciplines are overrepresented in the distribution of
which was initiated as early as 2004. SURPASS was developed based
adverse events. The recently described multidisciplinary SURgical PAtient
on literature and real-time observation data, and subsequently vali-
Safety System (SURPASS) checklist covers the entire surgical pathway from
dated in surgical practice.7 SURPASS is a surgical safety checklist
admission to discharge and is being validated in various ways. Malpractice
that covers the entire surgical pathway from admission to discharge.
claims constitute an important source of information on adverse events. In this
It aims to improve surgical patient safety by providing a frame for
study, surgical malpractice claims were evaluated in detail to assess the pro-
the surgical pathway and promoting interdisciplinary communica-
portion and nature of claims that might have been prevented if the SURPASS
tion. The checklist is split up into the different stages of the pathway
checklist had been used.
(preoperative ward, operating room, recovery or intensive care unit,
Methods: A retrospective claim record review was performed using the
postoperative ward, and discharge) and is multidisciplinary: ward
database of the largest Dutch insurance company for medical liability. All
doctor, nurse, surgeon, anaesthesiologist, and operating assistant are
accepted or settled closed surgical malpractice claims filed as a consequence
all responsible for completion of parts of the checklist (Table 1).
of an incident that occurred between January 1, 2004 and December 31, 2005
The external validation of SURPASS is being performed in
were included. Data on the type and outcome of the incident and contributing
various ways: by observation techniques, by real-time registration of
factors were extracted. All contributing factors were compared to the SUR-
intercepted incidents, and by studying the effect of the checklist on
PASS checklist to assess which incidents the checklist might have prevented.
patient outcomes in a multicenter setting13 . Malpractice claims con-
Results: We included 294 claims. Failure in diagnosis and peroperative dam-
stitute an interesting supplement to the above-mentioned methods.
age were the most common types of incident; cognitive contributing factors
Although not every malpractice claim is the consequence of an ad-
were present in two-thirds of claims. Of a total of 412 contributing factors, 29%
verse event, they provide a broad catchment point for information on
might have been intercepted by the SURPASS checklist. The checklist might
medical errors and adverse events, represent large groups of patients
have prevented 40% of deaths and 29% of incidents leading to permanent
and focus on adverse events that led to serious outcomes.12,14,15
damage.
In the present study, surgical malpractice claims were evaluated
Conclusion: Nearly one-third of all contributing factors in accepted surgical
in detail to assess the proportion and nature of claims that might have
malpractice claims of patients that had undergone surgery might have been
been prevented if the SURPASS checklist had been used.
intercepted by using a comprehensive surgical safety checklist. A considerable
amount of damage, both physical and financial, is likely to be prevented by
METHODS
using the SURPASS checklist.

(Ann Surg 2011;253:624–628) Record Selection


A retrospective record review was performed using the
database of MediRisk, the largest Dutch insurance company for med-
ical liability. MediRisk insures approximately 70% of all Dutch gen-
N early 1 in every 10 patients admitted to a hospital will undergo
an adverse event.1 The consequences of these events range from
temporary disability to death. Ever since this fact has been recognized,
eral hospitals. The insured institutes are broadly representative of
the teaching and nonteaching hospitals, with the exception of all 8
many studies have attempted to shed light on the incidence, nature, academic hospitals, none of which are insured by MediRisk.
causes and consequences of adverse event and medical errors.1–6 All malpractice claims filed as a consequence of an incident
Most of these studies have shown that surgical disciplines are over- that occurred between January 1, 2004 and December 31, 2005 were
represented in the distribution of adverse events; almost two-thirds of reviewed. The following inclusion criteria were used: (1) claim was
in-hospital events are associated with a surgical provider.1 To improve filed against a discipline involved in care for surgical patients (in-
surgical patient safety, numerous interventions have been proposed, cluding anesthesiology, surgical residents working in the emergency
among them the use of checklists.7–10 department and nursing staff on a surgical ward), (2) claim was closed,
Recently, the use of a checklist in the operating room was (3) claim had been accepted or settled, and (4) patient had undergone
shown to be associated with a significant decrease in postopera- surgery. Claims that did not involve a discipline involved in care for
tive complication and mortality rates.8 However, several studies have surgical patients, had not yet been closed or had been rejected, or
concerned patients who had not undergone surgery, were excluded.
From the ∗ Department of Surgery, Academic Medical Centre, Amsterdam,
†MediRisk, Utrecht, ‡Department of Quality and Process Innovation, Aca- Data Collection
demic Medical Centre, Amsterdam, the Netherlands. Of the included claims, all relevant documents were reviewed,
All authors declare that they have nothing to disclose.
Reprints: Marja A. Boermeester, MD, PhD, Department of Surgery, Academic Med- including medical and nursing records, legal documents, and experts’
ical Centre, Meibergdreef 9, G4–132.1, 1105 AZ Amsterdam, the Netherlands. assessments. The following data were extracted from the file: age,
E-mail: m.a.boermeester@amc.uva.nl. gender, the discipline, or department against which the claim was
Copyright C 2011 by Lippincott Williams & Wilkins
filed, and details of the incident: the type of incident, contributing
ISSN: 0003-4932/11/25303-0624
DOI: 10.1097/SLA.0b013e3182068880 factors, and the timing and outcome of the incident.

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Copyright © 2011 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Annals of Surgery r Volume 253, Number 3, March 2011 Claims Prevented by a Surgical Checklist

TABLE 1. Key Items of the SURgical PAtient Safety System (SURPASS) Checklist∗

Phase in Surgical Pathway Completed by Examples of Items

Preoperative in operating room Operating assistant information on operating schedule correct, all required implants/instruments/equipment
present
Preoperative on ward Ward doctor imaging present, laboratory checks performed, anticoagulants checked, medication
prescribed, relevant consultations performed
Surgeon informed consent registered, operation side marked
Anaesthesiologist actual condition of patient assessed, comorbidities/allergies checked, blood
products ordered, premedication ordered
Ward nurse patient prepared according to protocol, decubitus/fall/delirium screening protocol
executed, name tags on wrists, dentures removed
Preoperative time-out in operating room Surgeon, correct patient/procedure/side checked, positioning checked, antibiotic prophylaxis
anaesthesiologist, administered, comorbidities/allergies checked, required implants/instruments/
operating assistant equipment present and functioning
Postoperative at transfer to recovery Surgeon operative procedure documented, instructions concerning drains/medication/diet
room or ICU documented
Anaesthesiologist instructions concerning infusion fluids/medication/ventilation documented
At transfer from recovery or ICU to ward Anaesthesiologist or changes in postoperative instructions documented, ward doctor informed
intensivist of special circumstances
At discharge Ward doctor pathology and follow-up discussed, medication checked, outpatient appointments
made, discharge letter written
Ward nurse instructions concerning wound care/diet/medication explained to patient,
briefing for other care facility written

Modified from de Vries et al.7

Incident Classification
Each incident was classified in 1 of 10 types, based on types of
incidents described in the literature to date.11,12,16,17 Subsequently, the
most prominent contributing factors were identified, to a maximum of
2 factors per incident. The categories in which these contributing fac-
tors were arranged, were based on published classifications of causes
of surgical error.12,15,18 Next, a comparison was made of contributing
factors and items on the SURPASS checklist. When a contributing
factor corresponded to a checklist item, this factor might have been
prevented had the checklist been used. The timing of each contributing
factor was assessed as follows: preoperative in the outpatient clinic or
emergency department, preoperative during hospital admission, per-
operative, postoperative during hospital admission or postoperative
during outpatient monitoring. Finally, the outcome of each incident
was classified according to the classification of the Dutch National
Surgical Adverse Event Registration (LHCR).19,21 This classifica-
tion includes 4 grades: first is “temporary disability, no reoperation
required,” second is “temporary disability, resolved after reopera-
tion,” third is “permanent disability,” and fourth is “death”. These
categories correspond to grades in the recently described Accordion
Severity Grading System, although an extra category of “permanent
disability” is present in the LHCR.22

RESULTS
FIGURE 1. Flowchart of record selection.
Patient Characteristics and Type of Incident
Of 2128 claims filed as a consequence of incidents that oc-
curred between January 1, 2004 and December 31, 2005, 294 claims
fulfilled the inclusion criteria and were included in the present study Contributing Factors and Correspondence
(Fig. 1). The median age of claimants was 52 years and over half were to SURPASS
female (Table 2). The majority of claims were filed against general The factors contributing to the incidents are presented in
surgery (33%) and orthopaedic surgery (15%) (Table 2). A failure Table 4. Cognitive factors were present in two-thirds of all claims.
in diagnosis (26%) or treatment (13%), peroperative damage (20%), “Error in judgment,” “failure of vigilance/memory” and “failure in
wrong side (2%), wrong site (7%), wrong procedure (6%) or wrong communication between care providers” were the most frequent con-
patient (1%) constituted the majority of incidents (Table 3). tributing factors (29%, 16%, and 16%, respectively).


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de Vries et al Annals of Surgery r Volume 253, Number 3, March 2011

TABLE 2. Patient Characteristics (N = 294) TABLE 4. Contributing Factors and Correspondence to


Items on the SURPASS Checklist (412 Contributing Factors in
Frequency % 294 Claims)∗

Age (y; median) 52 - Correspondence


0−17 21 7 Category Frequency %† to SURPASS %§
18−39 76 27
40−59 100 35 Cognitive 224 (in 66‡ 50 22
>59 87 31 193 claims)
Female 171 58 Error in judgement 84 29 0 0
Discipline Failure of vigilance/ 48 16 15 31
General surgery 96 33 memory
Orthopaedic surgery 45 15 Insufficient imaging/ 22 8 5 23
tests performed
Oral surgery 29 10
No adherence to marking 34 12 25 74
Gynaecology/Obstetrics 28 10 or other protocol
Anaesthesiology 26 9 Insufficient monitoring/ 20 7 0 0
Emergency room physicians 24 8 symptoms not recognized
Urology 14 5 Insufficient examination 16 5 5 31
Ophthalmic surgery 12 4 of patient
Plastic surgery 12 4 Communication 71 (in 22 53 75
ENT surgery 3 1 66 claims)
Neurosurgery 3 1 Failure in communication 48 16 30 63
Cardiac surgery 2 1 between care providers
No (documentation of) 23 8 23 100
informed consent
System 62 (in 21 8 13
TABLE 3. Type of Incident Leading to Claim (N = 294) 62 claims)
Abnormal or difficult 18 6 0 0
Type Frequency % anatomy
Known risk of 16 5 0 0
Diagnosis (wrong/missed/delayed) 76 26 operation/procedure
Peroperative damage due to human error 59 20 Insufficient information/test 14 5 8 57
Wrong side/site/procedure/patient 46 16 results inconclusive
Treatment (wrong/insufficient/delayed) 37 13 Insufficient supervision 9 3 0 0
Medication 16 5 Logistics 5 2 0 0
Technical malfunction/ instrument or implant not present 14 5 Technical 54 (in 18 7 13
Unwanted outcome/ insufficient result 13 4 54 claims)
Postoperative ward care 13 4 Peroperative manual error 39 13 0 0
Retained instrument/gauze 11 4 Instrument/equipment 8 3 0 0
malfunction
Communication/instructions/informed consent 9 3
Material/equipment/ 7 2 7 100
instruments not present
Total 294 100
Cause not clear 1 (in 0
1 claims)
Total 412 (in 118 29
Of a total of 412 contributing factors, 29% corresponded to an 294 claims)
item on the SURPASS checklist and might have been intercepted by

using the checklist. In the categories, “no adherence to marking or A maximum of 2 contributing factors per claim could be identified.
†Represents proportion of total number of claims (294) in which ≥1 factor was
other protocol,” failure in communication between care providers,” present.
“no informed consent,” ”insufficient preoperative information,” and ‡Percentages add up to more than 100% because more than 1 contributing factor
“material/equipment/instruments not present” a large proportion was could be present.
covered by SURPASS items. §Represents proportion within category corresponding to SURPASS.

Timing and Outcome


The majority of incidents occurred as a consequence of pre-
operative or peroperative factors (Table 5). When looking only at the
contributing factors during hospital admission, 36% corresponded to of incidents (37%) required a reoperation to be resolved and 29% led
an item on the SURPASS checklist. In the preoperative stage, this to permanent disability, whereas 3% was fatal. In 40% of deaths and
percentage was as high as 69%. 29% of incidents leading to permanent damage, at least 1 contributing
When looking at the outcome of the incidents, 31% led to factor corresponded to an item on the checklist and might have been
temporary disability without reoperation (Table 6). More than a third prevented by using SURPASS.

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Annals of Surgery r Volume 253, Number 3, March 2011 Claims Prevented by a Surgical Checklist

categories. Most or all incidents that were the consequence of a failure


TABLE 5. Timing of Contributing Factors and
to adhere to protocols, failure to register informed consent, failure
Correspondence to Items on SURPASS Checklist (412
in communication between care providers, or the preoperative ab-
Contributing Factors in 294 Claims)
sence of information or material might have been prevented by using
SURPASS. Of the 70% of contributing factors that were not covered
Stage of Surgical Correspondence to
by SURPASS, some can be considered for amendments to the next
Patient Pathway Frequency % SURPASS∗ %
version of the checklist; for example, the inclusion of sponge count
protocols and preoperative registration of dental status. However, the
Preoperative in outpatient clinic 87 21 11 13
majority of contributing factors that did not correspond to SURPASS
or emergency department were unfit for inclusion in a patient-specific checklist. For instance,
Preoperative during hospital 90 22 62 69 incidents like failure to diagnose an anastomotic leakage, a decision
admission not to perform imaging in the ER, or administration of the wrong
Peroperative 154 38 23 15 drug, cannot be prevented by using a patient-specific checklist like
Postoperative during hospital 57 14 22 39 SURPASS. Other ways of standardization of processes, for exam-
admission ple, diagnostic guidelines, barcode-guided drug administration, and
Postoperative during outpatient 24 6 0 0 ward-based pharmacy teams, may aid in preventing these incidents.
monitoring Surgical malpractice claims have been studied before. In a
study published in 2006, 444 surgical malpractice claims were re-
Total 412 100 118 29
viewed to identify causes of surgical error and opportunities for
Overall correspondence to 36
prevention.15 The authors found that in 60% of cases, errors oc-
SURPASS when considering curred in pre- or postoperative care. Error in judgment, failure of
hospital admission† vigilance/memory and lack of technical competence were the most

Represents proportion within stage of surgical patient pathway corresponding to common contributing factors. These findings are quite similar to our
SURPASS. results. However, in the previously mentioned study, the consequences
†Since SURPASS is used during hospital admission, the contributing factors occur- of the surgical errors were more severe, leading to permanent damage
ring outside of the admission are not considered in this percentage.
or death in 65% of cases. This might reflect the different litigation
systems in place in the United States and the Netherlands; malpractice
claims in the Netherlands are handled through an arbitration system,
there are no jury trials and the patient can file a claim without a
TABLE 6. Outcome of Incidents and Correspondence to lawyer. The contingency system in place in the United States may
Items on SURPASS Checklist (N = 294) cause litigation to be pursued only when damages are severe enough
to render likely the chance of high payments, leading to a selection
Correspondence
of more severe injuries in the claims databases. A previous study
Outcome Frequency % to SURPASS∗ %† has shown that the Dutch system is associated with relatively high
rejection rates and low payments.23
Temporary disability, 91 31 28 31 In a study published by Griffen et al12 in 2007, 460 claims
no reoperation required
against general surgeons were reviewed to determine problematic as-
Resolved after reoperation 109 37 44 40 pects of surgical care. As in our study, failure in diagnosis or treatment
Permanent disability 84 29 24 29 and technical failures were the most common types of event. In ad-
Death 10 3 4 40 dition, surgeons identified deficiencies in care more often before and
Total 294 100 100 34 after operations than in the intraoperative period.

Represents number of incidents in which at least 1 contributing factor corresponded
Most surgical safety checklists described so far have been
to SURPASS. focused on the operating room.8,10,24 The present study concurs with
†Represents proportion of incidents within outcome category in which at least 1 published findings that surgical errors are not only prevalent inside the
contributing factor corresponded to SURPASS. operating room;7,11,12 only 38% of contributing factors occurred in the
peroperative setting. Interventions to standardize surgical processes
should target the entire pathway, from admission to discharge, to
intercept errors both outside and inside the operating room. Items
DISCUSSION such as the presence of implants or the cessation of anticoagulants
This retrospective review of 294 surgical malpractice claims should not be left unchecked until the time out procedure just before
showed that the most common type of incident leading to a claim was surgery, when it may be too late. The preoperative part of SURPASS
failure in diagnosis or peroperative damage. Of the 94 incidents that can intercept these and other incidents at an earlier time point—that
led to permanent disability or death, 30% might have been prevented is, when there is still time to correct them. In addition, the checklist
if the SURPASS checklist had been used. intercepts postoperative incidents, for example, related to instructions
The most common contributing factor was error in judgment. for postoperative care and medication at discharge. The SURPASS
In contrast, roughly a third of incidents were due to memory failures, checklist covered over two-thirds of all contributing factors in the
failures in communication, failure to adhere to a protocol or the preoperative stage and almost 40% of factors in the postoperative
absence of equipment or material; categories that could be corrected stage.
by adopting relatively easy measures like adequate documentation, Because SURPASS is so comprehensive, its implementation
preoperative marking of the operative site and checking of availability requires more resources than the implementation of a more concise
of all implants. Many of these measures are captured in the SURPASS checklist. However, implementation is certainly feasible; the checklist
checklist. has been successfully implemented both in academic hospitals and
The checklist might have intercepted approximately 30% of in regional teaching hospitals, and is being recommended as a best
contributing factors, mostly in the cognitive and communication practice by the Dutch Inspectorate for Health Care.25 Once SURPASS


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de Vries et al Annals of Surgery r Volume 253, Number 3, March 2011

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