Endocrinol Nutr. 2014;61(9):445---454

ENDOCRINOLOGÍA Y NUTRICIÓN

www.elsevier.es/endo

ORIGINAL ARTICLE

Development of a checklist in risk managementin thyroidectomy�

José Luis Pardal-Refoyoa,∗, Jesús Javier Cuello-Azcárateb, Luis Francisco Santiago-Penac

a Servicio de Otorrinolaringología, Sección de Cirugía tiroidea y paratiroidea, Complejo Asistencial de Zamora, Hospital Virgende la Concha, Grupo de Investigación en patología de tiroides y paratiroides, Zamora, Spainb Servicio de Anestesiología y Reanimación, Complejo Asistencial de Zamora, Hospital Virgen de la Concha, Grupode Investigación en patología de tiroides y paratiroides, Zamora, Spainc Unidad de Endocrinología, Complejo Asistencial de Zamora, Hospital Virgen de la Concha, Grupo de Investigación en patologíade tiroides y paratiroides, Zamora, Spain

Received 9 February 2014; accepted 7 April 2014Available online 23 October 2014

KEYWORDSThyroidectomy;Patient safety;Risk factors;Risk management;Root cause analysis;Comorbidity;Checklist

AbstractIntroduction: Communication failures may result in inadequate treatment and patient harm,and are among the most common causes of sentinel events. Checklists are part of cycles toimprove quality of the care process, promote communication between professionals involvedin the different stages, help detect failures and risks, and increase patient safety. The lack ofchecklists at each stage was identified as a factor contributing to communication failures.Objective: To design checklists at different stages of the thyroidectomy care process to improvethe communication between the professionals involved.Method: Multidisciplinary working team consisting of specialists in otolaryngology, anesthe-siology, and endocrinology. The process of thyroidectomy was divided into three stages(preoperative ---A---, operative ---B--- and postoperative ---C---). Potential safety incidents and fail-ures at each stage and their contributing factors (causes) were identified by the literaturereview and brainstorming. Checklists for each checkpoint were designed by consensus of theworking group.Results: The items correspond to factors contributing to the occurrence of incidents in the peri-operative stage of thyroidectomy related to patients, technological equipment, environment,management, and organization. Lists of items should be checked by the appropriate specialistin each stage.Conclusions: Checklists in thyroid surgery are tools that allow for testing at different check-

points data related to factors contributing to the occurrence of failures at each stage of thecare process.© 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

� Please cite this article as: Pardal-Refoyo JL, Cuello-Azcárate JJ, Santiago-Pena LF. Diseno de una lista de verificación en la gestión deriesgos en tiroidectomía. Endocrinol Nutr. 2014;61:445-454.

∗ Corresponding author.E-mail address: jlpardal@saludcastillayleon.es (J.L. Pardal-Refoyo).

2173-5093/© 2014 SEEN. Published by Elsevier España, S.L.U. All rights reserved.

446 J.L. Pardal-Refoyo et al.

PALABRAS CLAVETiroidectomía;Seguridaddel paciente;Factores de riesgo;Control de riesgo;Análisis de causa raíz;Comorbilidad;Lista de verificación

Diseno de una lista de verificación en la gestión de riesgos en tiroidectomía

ResumenIntroducción: Los fallos en la comunicación pueden provocar tratamiento inadecuado, dano alpaciente y son una de las causas más frecuentes de aparición de eventos centinela. Las listasde verificación son herramientas que forman parte de los ciclos de mejora de la calidad delproceso asistencial, facilitan la comunicación entre los profesionales implicados, ayudan en ladetección de fallos y riesgos e incrementan la seguridad del paciente. La falta de listados deverificación en cada etapa es un factor contribuyente en los fallos de comunicación.Objetivo: Disenar listas de verificación en distintas etapas del proceso asistencial de tiroidec-tomía para mejorar la comunicación entre los profesionales implicados.Método: Equipo de trabajo multidisciplinar constituido por especialistas en otorrino-laringología, anestesiología y endocrinología. El proceso de tiroidectomía se distribuyó en 3etapas (preoperatoria [A], operatoria [B] y postoperatoria [C]). Se identificaron los posiblesincidentes de seguridad y fallos en cada etapa y sus factores contribuyentes (causas) medianterevisión bibliográfica y tormenta de ideas. Se disenaron listados de verificación para cada puntode control mediante consenso del grupo de trabajo.Resultados: Los ítems se corresponden con factores contribuyentes en la presentación de inci-dentes perioperatorios en tiroidectomía relacionados con el paciente, los equipos tecnológicos,el entorno, la gestión y la organización.Conclusiones: Las listas de verificación en cirugía tiroidea son herramientas que permiten com-probar de forma reiterativa en distintos puntos de control del proceso de tiroidectomía datosque se relacionan con factores contribuyentes en la presentación de fallos en cada etapa delproceso asistencial.© 2014 SEEN. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.

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ntroduction

he most common incidents after thyroid surgery includeypocalcemia (transient 15.5---19.5%1; permanent from---0.3%1 to 4.8%2), recurrent laryngeal nerve palsy (tran-ient, 1.8---2.1%1; permanent, from 0---0.2%1 to 5.1%3),leeding (0.5---0.9%),1 and airway obstruction.4 Overallortality of thyroidectomy is however 46---64%,1 and is asso-

iated to multiple factors which have been investigatedithout reaching definitive conclusions.5 Treatment should

herefore be aimed at improving several aspects from thereoperative period.6

The safety incident is the event or circumstance whichaused or could have caused an unnecessary damageo the patient7; includes the concept of sentinel eventunexpected adverse event related to death, physical orsychological damage or risk of damage8). Thus, safety inci-ents result in actual or potential patient damage, use ofreatments and care unusual for the procedure (increasedare level, need for additional procedures and treatments),rolonged stay, inadequate stay, readmission, suspension ofurgical programming, and increased cost.8---10

Complexity and greater instrumentation of care probablynfluence the occurrence of incidents.11 Safety inci-ents usually have multiple causes (system or individualailures12) and should be investigated using root cause

nalysis (RCA) and Healthcare Failure Mode Effects andnalysis (HFMEA).9,13 HFMEA assesses the criticality (fre-uency and severity) and detectability of each potentialailure.9

atoi

The number of incidents related to health care has beenstimated to range from 2.9% and 16.6%, and that 27.4% to1.1% of them would be avoidable.14 Complications occur in---16% of surgical procedures requiring admission, leadingo mortality or permanent disability rates of 0.4---0.8%. It ishought that such complications could be prevented in ateast half the cases.15,16 In Spain, adverse events are avoid-ble in up to 42.8% of cases and occur in 9.3% of inpatientsor reasons attributable to care, being 1.6 times more com-on in patients with risk factors and up to 2.5 times more

ommon in patients over 65 years of age.10 Comorbidity hasn impact on incident occurrence, stay, and cost.17 Assess-ent of comorbidity before surgery allows for evaluating

he preoperative risk of morbidity and mortality based onndividual risk factors,17---19 but does not consider other con-ributing factors (equipment, environment, management,tc.). Several scales should therefore be used20 and inter-reted with caution, as no gold standard is available.21

There are various models which attempt to explain andnalyze the causes of safety incidents.22,23 Clinical riskanagement systems allow for a systematic solution of prob-

ems, contributing to improve the quality and safety ofedical action by preventing adverse events, identifying

he conditions that expose patients to risk, and prevent-ng or controlling such risk, involving several organizationalevels.13,24 This ‘‘implies practicing health care free from

voidable damages’’, which ‘‘involves development of sys-ems and processes aimed at reducing the probability ofccurrence of system failures and personal errors and atncreasing the probability to detect them when they occur

omy 447

Table 1 Recording of comorbidity. Charlson and Elixhauserscales.

Charlson scale

1 Myocardial infarctionCongestive heart failurePeripheral vascular diseaseCerebrovascular diseaseDementiaChronic lung diseaseConnective tissue diseasePeptic ulcerMild liver diseaseDiabetes

2 Hemiplegia---paraplegiaSevere kidney diseaseDiabetes with organic diseaseTumor of any typeLeukemiaLymphoma

3 Moderate to severe liver disease6 Metastatic solid tumor

AIDSTotal (groups: 0, 1---2, 3---4, >5)

Elixhauser scale

1. Congestive heart failure2. Cardiac arrhythmia3. Heart valve disease4. Lung circulation disease5. Peripheral vascular disease6. High blood pressure7. Paralysis8. Other neurological diseases9. Chronic lung disease10. Uncomplicated diabetes11. Complicated diabetes12. Hypothyroidism13. Kidney failure14. Liver disease15. Peptic ulcer without bleeding16. HIV disease17. Lymphoma18. Metastatic cancer19. Solid tumor with no metastasis20. Rheumatoid arthritis or vascular collagen disease21. Coagulopathy22. Obesity23. Weight loss24. Fluid and body electrolyte impairment25. Anemia from blood loss26. Anemia from other deficiencies27. Alcoholism28. Drug abuse29. Psychosis30. Depression

18 19

Development of a checklistin risk management in thyroidect

and to mitigate their consequences’’.25 The safety sys-tem allows for establishing criteria to decrease risk ofrecurrence, which would increase the possibility of seriousadverse outcomes.7,9

Communication of information from a healthcare profes-sional to another is one of the nine solutions to improvepatient safety proposed by the Joint Commission, because‘‘communication gaps may cause serious interruption in carecontinuity, inadequate treatment, and potential damage tothe patient’’, and has been reported to be one of the mostcommon causes of the occurrence of sentinel events.26

Checklists (CLs) are tools including a systematic sequenceof events related to the care process27 intended to consol-idate safety practices and to promote communication andteamwork between several clinical disciplines.15

In this regard, use of the ‘‘surgical safety checklist’’has allowed for decreasing the morbidity (from 11% to 7%)and mortality (from 6.2% to 3.4%) associated to surgery.15,16

However, the World Health Organization (WHO) guidelinesfor surgical safety are unevenly applied, even in the mostadvanced environments.15

Adequate communication benefits professionals andpatients, but there is no universally accepted modelto transmit perioperative critical information in thyroidsurgery based on a rational approach.28

The purpose of this study was to design CLs for differentstages of the thyroidectomy care process in order to improvecommunication between the professionals involved.

Materials and methods

To develop the CL, the methodology proposed byStufflebeam,29 summarized in the following points, wasused:

(1) Setting up of the multidisciplinary work team, consist-ing of specialists in otolaryngology, anesthesiology, andendocrinology.

(2) Identification of the critical stages in the thyroidectomyprocess: preoperative (A), operative (B), and postoper-ative (C). In each stage, checkpoints were identified ina logical sequential order.27

(3) Identification of incidences, safety incidents, risks, andpotential failures in each stage. Safety incidents weredefined as those related to sentinel events, any othersafety incident, quality indicator failures, incidentsrecorded in the medical or nursing clinical history,adverse effects of drugs, and patient complaints orclaims.9,12 HFMEA methodology8,9 was used to selectpotential failures. The risk matrix was created based onfrequency (incidence at our center and in the reviewedliterature), severity (impact on the patient12), anddetectability (difficulty to detect the risk or situationspreceding the failure). Incidents of very high severity(catastrophic), undetectable (or difficult to detect) inci-dents, or highly critical incidents (severity by frequencyproduct) were prioritized.8,9

(4) Item identification. Items related to safety incidentsand failures in each stage, as well as contributing fac-tors (causes), were selected by brainstorming adaptingthe taxonomy used in the literature reviewed.7,9,12 The

Source: Charlson et al. and Elixhauser et al.

448

J.L. Pardal-Refoyo

et al.

1-Setting up of the team Otolaryngology, anesthesiology, endocrinology

2-Identification of thyroidectomyprocess stages and checkpoints

A: PREOPERATIVE STAGEA1: OUTPATIENT CLINIC

A1.1: ENDOCRINOLOGY CLINICA1.2: SURGICAL CLINICA1.3: PREANESTHESIA CLINIC

A2: WARD ADMISSION

B: OPERATIVE STAGEB1: ENTRY. Before induction of anesthesiaB2: SURGICAL PAUSE Before skin incisionB3: EXIT. Before patient leaves operating room

C: POSTOPERATIVE STAGEC1: RECOVERY ROOMC2: HOSPITALIZATION WARDC3: CLINIC

C3.1: OTOLARYNGOLOGY CLINICC3.2: ENDOCRINOLOGY CLINIC

3-Identification of incidences,safety incidents, risks or potentialfailures in each stage

SeverityFrequencyDetectability

Suffocating hematomaAirway obstruction: difficult airway /Impossibility of intubation / Impossibility ofreintubation / Acute respiratory insufficiencyrequiring reintubation or tracheostomyPneumothoraxTracheal rupture / emphysemaThyrotoxic stormEsophageal fistulaBilateral RLN palsyTetany (hypocalcemia/hypomagnesemia)

ComorbiditySymptoms and signs: nausea, vomiting, cough,Headache / pain, bleeding (drainages, wound),infection (fever, local)

Surgical delaySurgery suspensionProlonged stayClaimComplaint

Communication deficiencies:Lack of documentationLack of checklistsInformation failures (oral information, written reports)Information access/accessibility

4-Item identification5-Preparation of checklists

- Evaluation- Final list

Patient: Comorbidity. Preoperative. Drugs (listof drugs). Prior iodinated contrastsTechnological equipment: Verification ofequipment: hemostasis and neuromonitoring,monitoring of anesthesia (ECG, BP,temperature, relaxation)Checking of symptoms and signs: cough,vomiting, pain, swallowing, breathing, comfortManagement: Accompaniment. Check listings.Care continuity.Organization: Care at the adequate medicalunit (location). Nursing care at the adequateunit. Correct appointment (day, time).Admission and discharge system. Compliancewith timetables and planning. Accessibility ofinformation.

Communication:Information: Patient identification. Verbal information.Understanding of information.Laryngoscopy.Airway: prostheses, preoperative evaluation,postoperative precautions. Voice. Laboratorytests: Thyroid (TSH) and parathyroid (Ca vit. D,PTH) function; Hemostasis / Coagulation.Imaging studies (US, CT, MRI, PET). Diagnoses.Proposed / scheduled surgical procedure.Laterality. Information sheets. Incidence andincident recording.

Documentation: Clinical history of each specialty.Correct clinical history number. Documentation of entryand exit for each stage.Informed consent (surgery, anesthesiology).Final clinical report in each step. Therapeutic indicationsand indications on comorbidity in each step.Care guideline available (diagnosis and treatmentprotocols). Satisfaction survey. Care guideline. Checklists.

6-Construction of indicators- Related to patient safety

- Related to administrativeaspects

• safety incidents• repeat surgery• stays• surgery suspension• readmissions• claims

Figure 1 Method: Development of checklists.

Development of a checklistin risk management in thyroidectomy 449

Table 2 Checklists in thyroidectomy. Perioperative stage (A).

A: preoperative

A1: outpatient clinic

A1.1: endocrinologyclinic

A1.2: surgical clinic A1.3: preanesthesia clinic A2: ward admission

EntryAdequate unit yes/noPatient identificationyes/noCorrect clinical historynumberEntry documentyes/noPatient accompaniedyes/noComorbidity (seebelow [Table 4])Drug list yes/noLaboratory testsyes/no-Ca/P levelyes/no-vitamin D levelyes/no-Mg levelyes/no-tumor markersyes/no/notapplicable)Documented imagingstudies yes/no(ultrasonographyyes/no/notapplicable-CTyes/no/notapplicable-MRIyes/no/notapplicable)Other yes/no/notapplicable

ExitEndocrinology clinicalhistory yes/noPatient informationyes/noEndocrinology clinicalreport yes/noReferral form to A1.2yes/no

Diagnosis yes/noSurgical procedureindicated yes/no

EntryAdequate unit yes/noPatient identification yes/noCorrect clinical history numberAccompanied patient yes/noComorbidity (see below[Table 4])Drug list yes/noLaboratory tests yes/no-Ca/Plevel yes/no-vitamin D levelyes/no-Mg level yes/no-tumormarkers yes/no/notapplicable)Documented imaging studiesyes/no (ultrasonographyyes/no/not applicable-CTyes/no/not applicable-MRIyes/no/not applicable)Other yes/no/not applicableDocumentation:General clinical history yes/noEndocrinology clinical historyyes/noEndocrinology report yes/noReferral form from A1.1 yes/no

Iodinated contrast media inprior 6 months yes/noDrug allergies yes/noAnticoagulants/antiaggregantsyes/noCoagulopathies yes/noProsthesis yes/noPrior local surgery yes/noIndirect laryngoscopy yes/noPrior voice disease yes/noAirway evaluation yes/noNeck mobility evaluationyes/no

ExitSurgical clinical history yes/noPatient information yes/noSurgical clinical report yes/noInformed consent yes/noIndications on comorbidityyes/no/not applicableReferral form to A1.3

Procedure proposed from A1.1yes/noProgrammed procedure yes/noLaterality yes/no

EntryAdequate unit yes/noPatient identification yes/noCorrect clinical history numberEntry form from A1.2 yes/noAccompanied patient yes/noComorbidity (see below[Table 4])Drug list yes/noLaboratory tests yes/no(thyroid profile yes/no-Ca/Plevel yes/no-vitamin D levelyes/no-Mg level yes/no-electrolytes-proteins---hepaticand renal profile)

DocumentationGeneral clinical history yes/noEndocrinology clinical historyyes/noEndocrinology clinical reportyes/noSurgical clinical history yes/noSurgical clinical report yes/no

ExitEuthyroid yes/noECG-cardiological assessmentyes/noPrior anesthetic incidentsyes/noASA gradeAirway risk evaluation yes/noDifficult airway yes/no

Anesthesiology clinical historyyes/noAnesthesiology clinical reportyes/noPatient information yes/noInformed consent yes/noIndications on comorbidityyes/no/not applicable

EntryAdequate unit yes/noPatient identificationyes/noCorrect clinical historynumberAdmission form yes/noAccompanied patientyes/noDrug list yes/no

DocumentationGeneral clinical historyyes/noEndocrinology clinicalhistory yes/noEndocrinology clinicalreport yes/noSurgical clinical historyyes/noAnesthesiology clinicalhistory yes/noInformed consent forsurgery yes/noAnesthesiology informedconsent yes/noPreanesthetic indicationsand treatmentyes/no/not applicableDrugs discontinuedyes/noDrugs continued yes/noAnticoagulation regimenyes/no/not applicableProphylaxis for DVTEyes/no/not applicable

ExitVital signs yes/noNursing historyEuthyroid yes/no

450 J.L. Pardal-Refoyo et al.

Table 3 Checklists in thyroidectomy. Operative stage (B).

B: operative stage

B1: entry. Before inductionof anesthesia

B2: surgical pause Beforeskin incision

B3: exit. Before patientleaves operating room

Patient has confirmedHis/her identitySurgical siteProcedureConsent

Site marking/not applicable

Anesthesia safety controlhas been completed

Pulse oxymeter placedand active

Has the patient knownallergies? No/yes

Difficult airway/riskof aspiration?No/yes, and instrumentsand equipment/helpavailable

Risk of bleeding > 500 mL(7 mL/kg in children?No/yes, and intravenousaccess and adequate fluidsavailable

Confirm that all teammembers have introducedthemselves by name androle

Surgeon, anesthetist, andnurse verbally confirm:Patient identitySurgical siteProcedure

Prevention of criticalevents:Surgeon reviews: critical orunforeseen steps, operatingtime, and expected bloodloss

The anesthesia teamreviews: if patient has somespecific problem

The nursing team reviews: ifsterility has been confirmed(with results of indicators)and doubts or problemsrelated to instruments andequipment exist

Has antibiotic prophylaxisbeen administered in thepast 60 min? Yes/notapplicable

Can essential diagnosticimages be visualized?Yes/not applicable

Nurse verbally confirmswith the team:The name of the procedureperformedThat counts of instruments,gauzes, and needles arecorrect (or not applicable)Sample labeling (includingpatient name)If problems related toinstrumentation andequipment are pending

Surgeon, anesthetist, andnurse review the mainaspects of patient recoveryand treatment

Exit

Patent airway yes/noVerification of dressings andsurgical woundVerification of drainagesSurgical procedure reportyes/noAnesthesiology reportyes/no

Postoperative control sheetsof Ca and PTH are available

All treatment andpostoperative careinstructions have beenwritten down

Complete documentationyes/noHemostasis system availableyes/noNeuromonitoring systemavailable yes/no

Compliance with fastingyes/noDenture, prosthesis, ormetallic objects yes/noPreanesthetic indicationsand treatment yes/no

Patient temperaturemonitoringNeuromuscular relaxationmonitoringVerification of laterality(L1)Verification of hemostaticsystem yes/noVerification ofneuromonitoring systemyes/noFinal verification of vagusnerve signal

Development of a checklistin risk management in thyroidectomy 451

Table 4 Checklists in thyroidectomy. Postoperative stage (C).

C: Postoperative

C3: clinic

C1: recovery room C2: hospitalization ward C3.1: surgical clinic C3.2: endocrinologyclinic

EntryAdequate unit yes/noPatient identificationyes/noCorrect clinical historynumber

All treatment andpostoperative careinstructions are clearDrug availabilityyes/no (Ca-vit D, Mg)

TemperaturemonitoringECGBlood pressurePain

Patent airway yes/noEmphysema yes/noVerification ofdressings and surgicalwoundVerification ofdrainagesGeneral patient stateWound:bleeding/hematomayes/noParesthesia yes/noRestlessness yes/noVomiting yes/no

ExitRecovery reportyes/noIncidents have beenrecorded yes/noDischarge criteria havebeen verified yes/noInformation to patientand companionsyes/no/not applicable

EntryAdequate unit yes/noPatient identification yes/noCorrect clinical historynumberAccompanied patient yes/noDrug list yes/no

All treatment andpostoperative careinstructions are clearDrug availability yes/no(Ca-vit D, Mg, levothyroxine)Verification of labeling yes/noIndications for control ofcalcemia and alarm signs ofhypocalcemia are followedyes/no

Surgical care guidelineavailable yes/no

Patent airway yes/noVoiceEmphysema yes/noVerification of dressingsand surgical woundVerification of drainagesGeneral patient stateWound: bleeding/hematomayes/noParesthesia yes/noRestlessness yes/noVomiting yes/no. VoiceSwallowingPainBlood pressure

ExitIndirect laryngoscopyHospital discharge reportDischarge criteria metPatient understandstreatment scheme(levothyroxine yes/no/notapplicable-Ca/vit Dyes/no/not applicable)Review day for C3.1 and C3.2Request of laboratory control(6 weeks)

EntryAdequate unit yes/noPatient identificationyes/noCorrect clinical historynumberAccompanied patientyes/noDrug list yes/no

DocumentationGeneral clinical historyyes/noEndocrinology clinicalhistory yes/noHospital discharge reportHospitalization episodeHistological reportyes/noUse of iodinated contrastmedia yes/noControl of treatmentschemes (adequate drugsand dose: levothyroxineyes/no/notapplicable-Ca/vit Dyes/no/not applicable-anticoagulation regimenyes/no/not applicable)

Indirect laryngoscopyVoiceSwallowingScar

ExitSurgical clinic reportVerbal informationPatient has understoodverbal informationVerification ofappointment for reviewby endocrinology C3.2

Satisfaction surveySuggestions-complaints

EntryAdequate unit yes/noPatient identificationyes/noCorrect clinical historynumberAccompanied patientyes/noDrug list yes/no

DocumentationGeneral clinical historyyes/noEndocrinology clinicalhistory yes/noEndocrinology clinicalreport yes/noSurgical clinical historyyes/noHospitalization episodeHospital discharge report

Histological reportyes/noControl of treatmentschemes (adequate drugsand dose: levothyroxineyes/no/notapplicable-Ca/vit Dyes/no/not applicable)See laboratory control

Request for ablationtherapy with radioiodineyes/no/not applicableRequest forsupplemental testsduring ablation therapy

ExitIssue of endocrinologyreportVerbal informationPatient has understoodverbal information

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Acknowledgements

52

lack of CLs in each stage was identified as a factorcontributing to communication failures. Evaluation ofcomorbidity in the preoperative period was includedusing the Charlson and Elixhauser scales18,19 (Table 1).The operative period included the WHO listing.15

5) CL preparation Items for each process stage were rankedby consensus of the work group. A first review of CLcontents was done to verify all items, checkpoints, andCL availability, and to assess the mean time needed toverify each point (2 min, 95% CI: 1.14---2.86 min).

Fig. 1 summarizes the methodology used for designingLs.

esults

Ls are shown in Tables 2---4.Listings allow for detecting omissions by recall (mnemon-

cs) based on reiteration of points that should be checked.27

Checkpoints are planned at each stage in the processendocrinology clinic before and after surgery; surgicallinic before and after thyroidectomy; anesthesiology clinicefore surgery; operating room; recovery room and hospi-alization ward before and after surgery) and are verified byhe corresponding specialist at each stage.

Item correspond to factors contributing to the poten-ial occurrence of perioperative incidents in thyroidec-omies related to the patient, control of symptoms andigns, technological equipment, management, organiza-ion, and communication (information and documenta-ion).

iscussion

atient safety is the sum of management and technologi-al factors at different levels with multiple connections.5

t is based on a culture of safety aimed at detect-ng and analyzing incident, search for the root causesn the systems, prepare guidelines to prevent recur-ence, and devise prevention plans based on con-inuous improvement of processes and staff involve-ent, helping overcome barriers for implementation of

hanges.12

Adverse events are related to all stages in the care pro-ess, and their consequences are seen in patients (death,equelae, complications) and in the process (hospital stay,eadmissions, additional treatments) and increase costs.10

auses (contributing factors) may be immediate (patient,eam, environment) or root causes (management, organiza-ion, regulation).7

Patient care specialization implies more units and staff,hich may make communication difficult26 Oral communi-ation between professionals appears to be the best way toransfer patients, but the current design of care provisionystems does not allow for it.26

Each type of failure may have multiple causes, includingack of CLs, computerized systems, or cognitive aids.27,30 CLs

acilitate communication in patient transfers in the processtages, allow for standardized evaluation and transmis-ion of updated information about patient state, decreaseonfusion, incorporate repetition and re-reading steps, and

Ws(

J.L. Pardal-Refoyo et al.

estrict exchange to the information needed to provide safeare to the patients.26

CLs are cognitive aids with an essential role in manage-ent of errors which are rarely included for publication.27

CLs serve to verify and identify the critical risk pointselated to the potential occurrence of safety incidents.12,27

The Work group of the clinical practice guidelines forafety of surgical patients recommends use of CLs inny surgical procedure to improve safety of surgery andecrease preventable complications with a strong grade ofecommendation.16

However, use of CLs has a moderate efficacy toromote changes leading to more effective mea-ures, such as organizational measures and processutomatization/computerization.7 On the other hand,xcess CLs may complicate the process by overburdeningrofessional activity (the so-called ‘‘checklist fatigue’’).27

No specific tools have been developed for interdisci-linary communication in thyroid surgery. The Americanhyroid Association prepared a listing of information includ-

ng all essential perioperative data that should be availableo the professionals involved, and recommended transmis-ion of information through electronic sheets with a synopticnd narrative report.28

The methodology used to develop the CLs presenteddded to the recommended methods for designing CLs29 theFMEA method8,9 for identification and classification of theafety incidents and potential failures which were the basisf items included. This methodology combines the literatureeview with concept-sharing by experts for CL design.27,29

Ls facilitate routine verification of aspects that may con-ribute to cause critical (severe or frequent) or difficulto detect failures. Non-compliance helps professionals re-valuate whether or not the process may continue to theext stage.

While application of CLs is not always directly correlatedo significant improvements in patient care or error reduc-ion, there are no data suggesting that CLs contribute todverse event occurrence, and they do contribute to adher-nce to best practices and reduction of omission errors.27

To assess the results of CL implementation in thyroidurgery, we propose using indicators that measure patientafety issues (safety incidents, repeat surgery) and admin-strative aspects (hospital stay, surgical suspension rate,eadmission rates and complaints).7---10

In conclusion, it should be emphasized that CLs allow forepeated verification at different checkpoints of the thy-oidectomy process of data related to factors contributing tohe occurrence of failures in each stage of the care process.

onflicts of interest

here are no conflicts of interest.

e thank Dr. Carlos Ochoa Sangrador, head of the researchupport unit, Pedro Felipe Rodríguez de la Concepciónlibrary), and Beatriz Pardal Peláez for manuscript review.

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Development of a checklistin risk management in thyroidect

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