Patient Safety Strategy for the National Health System · Patient Safety Strategy for the National Health System 2015-2020 Period ... Maribel Macian Morro ... promotes the Patient

PatientSafetyStrategyfortheNationalHealthSystem

2015-2020Period

HEALTH2015MINISTRYOFHEALTH,SOCIALSERVICESANDEQUALITY

PatientSafetyStrategyfortheNationalHealthSystem.2015-2020

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2015-2020Period SANIIDAD2015

MINISTERIODESANIDAD,SERVI HEALTH2015

MINISTRYOFHEALTH,SOCIALSERVICESANDEQUALITY

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DocumentapprovedbytheInstitutionalPatientSafetyStrategyCommittee

ApprovedbytheNationalHealthSystemInterterritorialCouncilonJuly29,2015.

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2015-2020Period

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MINISTRYOFHEALTH,SOCIAL

SERVICESANDEQUALITY

Technicalcoordinationanddrafting

– YolandaAgraVarela.HeadofthePatientSafetyUnit.Sub-directorateGeneralofQualityandCohesion

Sub-directorateGeneralofQualityand

Cohesion:

– PalomaCasadoDurandez.DeputyDirectorGeneralofQualityandCohesion

– InésPalancaSánchez.HeadoftheAccreditationandAuditsUnit

– MaríaJoséGarcíaDíaz.SectionChief.PatientSafety.

– CarmenÁlvarezGonzález.ServiceChief.AccreditationandAudits

DirectorateGeneralofPublicHealth,

QualityandInnovation:

– JoséJavierCastrodezaSanz.DirectorGeneralofPublicHealth,QualityandInnovation

SCIENTIFICCOORDINATION:

– CarlosAibarRemón.HeadofthePreventiveMedicineServiceoftheLozanoBlesaUniversityHospitalClinic.Zaragoza

– PilarAstierPeña.FamilyMedicinePhysician.CaspeHealthCenter.AragonHealthService

– MercedesCarrerasViñas.FormerSubdirectorofCitizenAssistanceandQualityoftheGalicianHealthService.SantiagodeCompostela

– JuanIgnacioGómez-ArnauDiazCañabate.HeadoftheAnesthesiaServiceoftheAlcorconFoundationUniversityHospital.Madrid

– MariaJoséOteroLópez.InstitutefortheSafeuseofMedications(ISMPSpain).UniversityofSalamancaHealthcareComplex-IBSAL

– MercedesPalomarMartínez.ClinicalDirectoroftheCriticalCareUnitsoftheArnaudeVilanovaandSantaMaríadeLéridaHospitals.Lérida

INSTITUTIONALTECHNICALCOMMITTEE

OFTHEHEALTHREGIONS

– ANDALUSIA:ConcepciónBarreraBecerra

– ARAGON:JulianMozotaDuarte– ASTURIAS:ManuelValledorMéndez– BALEARICISLANDS:CarlosCampillo

Artero-BASQUECOUNTRY:EnriquePeiróCallizo– CANARYISLANDS:PalomaGarciade

Carlos– CANTABRIA:TriniValleMadrazo– CASTILE&LEON:MaríaJoséPérez

Boillos– CASTILE-LAMANCHA:FuencislaMartín

Jusdado– CATALUNYA:JosepDavinsiMiralles– CEUTA/MELILLA: María Antonia Blanco

Galán– EXTREMADURA:YolandaAnesdelAmo– GALICIA:BeatrizPaisIglesias– LARIOJA:AdolfoCestafeMartínez– MADRID:AlbertoPardoHernández– MURCIA:SusanaValbuenaMoya– NAVARRE:IsabelRodrigoRincón– VALENCIA:CristinaMaríaNebotMarzal

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PARTICIPATINGSCIENTIFICSOCIETIES:

– Spanish Association of Medical

Biopathology (AEBM). María ÁngelesCuadradoCenzual

– Spanish Association of Surgeons (AEC).VictorianoSoriaAledo

– Spanish Academy of Dermatology andVenereology (AEDV). Elena de las HerasAlonso

– Spanish Association of Gastroenterology(AEG).XavierCalvetCalvo

– Spanish Association of Health care RiskManagementandPatientSafety(AEGRIS).JoséMaríaRuízOrtega

– Spanish Association of Mental HealthProfessional Neuropsychiatry (AEN).AmaliaTesoroAmate

– Spanish Association of Perfusionists(AEP).MarisolGarcíaAsenjo

– Spanish Association of Primary PediatricCare(AEPAP).JuanRuízCanelaCáceres

– Spanish Association of Clinical Psychologyand Psychopathology (AEPCP). ConsueloEscuderoÁlvaro

– SpanishAssociationofPediatrics (AEPED).AntonioUrdaCardona

– Spanish Association of Major OutpatientSurgery(ASECMA).MatildeZaballosGarcía

– Federation of Associations of CommunityNursing and Primary Care (FAECAP).MaribelMacianMorro

– NationalGroupfortheStudyandAdvisoryin Pressure Ulcers and Chronic Sores(GNEAUPP).J.JavierSoldevillaAgreda

– SpanishSocietyofAngiologyandVascularSurgery(SEACV).SandraRedondoLópez

– Spanish Society of Allergology and

Clinical Immunology (SEAIC). MarReañoMartos

– Spanish Society of PathologicalAnatomy (SEAP). Antonio MartínezLorente

– Spanish Society of Cardiology (SEC).DomingoMarzalMartín

– SpanishSocietyofCareQuality(SECA).RosaMaríaSalazardelaGuerra

– Spanish Society of Thoracic-Cardiovascular Surgery (SECTCV). JuanBustamanteMunguira

– Spanish Diabetes Society (SED). JuanGirbésBorrás

– Spanish Society of Anesthesiology,Resuscitation and Pain Treatment(SEDAR).FernandoGilsanzRodríguez

– Spanish Society of Expert StomalTherapyNursing(SEDE).MaríaAdelinaFernándezGarcía

– SpanishPainSociety(SEDOLOR).RafaelGálvezMateos

– Spanish Society of Intensive Care andCoronary Care Unit Nursing (SEEIUC).RosaGarcíaDíez

– Spanish Society of Endocrinology andNutrition (SEEN). Elena NavarroGonzález

– Spanish Oncology Nursing Society(SEEO).CarmenVenaFernández

– Spanish Society of CommunityPharmacy (SEFAC). Luís GarcíaSevillano

– Spanish Society of Primary CarePharmacists (SEFAP). Ester AmadoGuirado

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– Spanish Society of Clinical Pharmacology(SEFC).CristinaAvendañoSolá

– Spanish Society of Hospital Pharmacy(SEFH).InmaculadaTorresLloveras

– SpanishSocietyofMedicalPhysics(SEFM).MariaLuisaEspañaLópez

– Spanish Society of Hematology andHemotherapy (SEHH). Pedro SánchezGodoy

– Spanish Society of Immunology (SEI).JavierCarboneCampoverde

– SpanishSocietyofInfectiousDiseasesandClinical Microbiology (SEIMC). Juan PabloHorcajadaGallego

– Spanish Society of Geriatric Medicine(SEMEG).JuanJoséSolanoJaurrieta

– SpanishSocietyofPrimaryCarePhysicians(SEMERGEN). National Member forPatientArea.AlbertoLópezRocha

– Spanish Society of Emergency Medicine(SEMES).PabloBuscaOstolaza

– SpanishSocietyofFamilyandCommunityMedicine (SEMFYC).MaríadelPilarAstierPeña

– Spanish Society of General Practitionersand Family Physicians (SEMG). JuanaSánchezJiménez

– Spanish Society of Internal Medicine(SEMI).RaquelBarbaMartín

– Spanish Society of Intensive Care, CriticalCareandCoronaryCareUnits(SEMICYUC).FranciscoFernándezDorado

– Spanish Society of Nuclear Medicine andMolecular Imaging (SEMNIM). RaquelJoverDíaz

– Spanish Society of PreventiveMedicine, Public Health and Hygiene(SEMPSPH).HenarRebolloRodrigo

– Spanish Society of Nephrology (SEN).ManuelMacíaHeras

– Spanish Society of Neonatology(SENeo).MónicaRiazaGómez

– Spanish Society of Parenteral andEnteral Nutrition (SENPE). MariolaSirvent

– Spanish Society of Medical Oncology(SEOM).JorgeAparicioUrtasun

– Spanish Society of Radiation Oncology(SEOR).JoséPardoMasferrer

– Spanish Psychiatric Society (SEP).MiguelGutiérrezFraile

– Spanish Society of Pneumology andThoracic Surgery (SEPAR). AlbertoCapelasteguiSaiz

– Spanish Society ofDigestive Pathology(SEPD).SenadorMoránSánchez

– SpanishSocietyofRadiationProtection(SEPR).FranciscoJavierRosalesEspizua

– Spanish Society of Clinical Chemistryand Molecular Pathology (SEQC).FranciscoJavierMéridadelaTorre

– SpanishSocietyofRheumatology(SER).JuanÁngelJoverJover

– Spanish Society of Medical Radiology(SERAM).ÁngelMoralesSantos

– Spanish Society of Vascular andInterventional Radiology (SERVEI).MaríaDoloresFerrerPuchol

– Spanish Union of Scientific NursingSocieties (UESCE). Carmen Luisa DíazÁlvarez

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NATIONALHEALTHSYSTEMCITIZENHEALTHSCHOOLNETWORK

– AssumpcióGonzálezMestre.CatalunyanHealthInstituteExpertPatientProgram

– SergiBlancafortiAlias.Patients’University– EstibalizGamboaMoreno.OsakidetzaExpertPatientProgram– MercedesCarrerasViñas.GalicianCitizenHealthSchool– LuisMarianoLópezLópez.,CantabrianHealthSchool– PilarVicenteGarcía.CitizenTrainersNetwork– CarmenFerrerArnedo.TechnicalDirectoroftheStrategyforDealingwith

Chronicity

OTHEREXPERTSCONSULTED:

– JesúsAranazAndrés.PreventiveMedicineService.RamónyCajalUniversityHospital.Madrid

– JoaquimBañeresAmella.AvedisDonabedianFoundation.Barcelona– JoséJoaquínMiraSolves.MiguelHernándezUniversity.Alicante– MaríaLuisaRamírezVera.RadioactiveandMedicalExposuresDivision.Nuclear

SafetyCouncil.Madrid– CarlosPrietoMartín.MedicalPhysicsService.HealthResearchInstitute.San

CarlosHospitalClinic.Madrid– EnriqueTerolGarcía.DGSANTE.UnitD2HealthCareSystems.European

Commission.Brussels

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TABLEOFCONTENTS

TABLEOFCONTENTS..................................................................................................................................10PRESENTATION...........................................................................................................................................12INTRODUCTION..........................................................................................................................................14TECHNICALNOTE.......................................................................................................................................161.GENERALASPECTS..................................................................................................................................18

a.Justification.........................................................................................................................................18b.Purposeofthestrategy:mission,visionandoverallobjective..........................................................19c.Targetpopulation...............................................................................................................................19d.Situationanalysis................................................................................................................................20

i. Magnitudeandimpactofhealthcare-relatedharm................................................................20ii. Interventionscarriedoutattheinternationallevel......................................................................29

iii.InterventionscarriedoutintheNationalHealthSystem..............................................................502.STRATEGICLINESOFACTION.................................................................................................................80

� Strategiclineofaction1:Patientsafetyculture,humanandorganizationalfactors,andtraining 80� Strategiclineofaction2:Safeclinicalpractices...........................................................................82� Strategiclineofaction3:Riskmanagementandincidentreportingandlearningsystems.........95� Strategiclineofaction4:Patientandcaregiverparticipationfortheirsafety.............................98� Strategiclineofaction5:Researchintopatientsafety..............................................................100� Strategiclineofaction6:Internationalparticipation.................................................................101

3.EVALUATION.........................................................................................................................................1024.GLOSSARY.............................................................................................................................................1045.ABBREVIATIONS&ACRONYMS............................................................................................................1096.LISTINGOFTABLES...............................................................................................................................1127.LISTINGOFFIGURES.............................................................................................................................1138.BIBLIOGRAPHY......................................................................................................................................114

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PRESENTATION

The Ministry of Health, Social Services and Equality (MSSSI) fosters andpromotesthePatientSafetyStrategyfortheNationalHealthSystem(NHS),whichhasbeen being carried out as of 2005 in collaborationwith theHealth Regions and theInstitutoNacionaldeGestiónSanitaria (INGESA), integrating thecontributionsof thehealthcareprofessionalsandofthepatientsbywayoftheirorganizations.

The objectives of this strategy are initially aimed at promoting and furtherenhancingpatientsafetycultureinthehealthcareorganizations,incorporatinghealthcare risk management, training the professionals and patients in basic aspects ofpatient safety, implementing safepractices andgettingpatients and citizensactivelyinvolved.

After ten years of the Patient Safety Strategy development , this update isbeing set out for a further five-year period (2015-2020), in order to provide anoverviewofwhathaspreviouslybeendoneand to facilitatedecisionmakingon thebasisofaconsensusreachedaboutPatientSafetyfortheNHSforthisnewperiod.

Theprocessofassessingwhathasalreadybeendoneentailsrecognizingthat:theestablishedcollaboration,withtheHealthRegions, hasworkedefficientlyHealthRegions; thecontributionsof theprofessionalsandtheirorganizationhasturnedouttobecrucial;thescientificsocietieshaveplayedakeyrole;andthatthepatientsandtheirorganizationshavebeenaninnovativeelementhavingaffordedthepossibilityofmakingprogressinpatientempowerment.

Theupdatepresentedhereinincorporatesthestrategiclinesofactionalreadysetout,includesthecurrentinternationalrecommendationsonthesubjectofpatientsafety,incorporatestheachievementsandstrongpointsattained,proposesobjectivesand recommendations based on the best available evidence, and proposes anassessmentsystemonthebasisofaconsensuswiththeHealthRegionsHealthRegionswhichwillmakeitpossibletomeasurethescopeofthisnewstrategyinastandardizedmanner.

The process of designing this strategy has beenmade possible thanks to thework of the scientific and technical coordinators of the strategy, the institutional

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technical committeeof theHealthRegionswhichhaveassumed the commitmentoftaking on this update in a rigorous, thoroughmanner, as well as the professionals,through their scientific societies, and the patients who are taking part with theircontributions and commitment and other experts from organizations interested inpatientsafety.

Iwould like to expressmy gratitude to all thosewho have taken part in thepreparationofthisdocument,whichwillundoubtedlycontributetofurtherenhancingpatientsafetyintheNationalHealthSystem.

AlfonsoAlonsoAranegui

MinisterofHealth,SocialServicesandEquality

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INTRODUCTION

Further enhancing the quality of the health care provided has always beeninherenttotheNHSprinciples,asisinferredfromSpain’sNationalHealthLaw,TitleIof which includes, as one of the measures to be carried out by the health careadministrations, thatofkeepingacheckonand furtherenhancing thequalityof thehealth care provided at all levels thereof1. This law served as the framework ofreferenceonthesubjectofqualityinthehealthcareservices,whichhasbeenfurtherexpandeduponunder the lawsand regulationsof thedifferentHealthRegionsoverthepastfewyears.

It was within this context and under the protection of the 2003 Law onCohesionandQualitythattheMSSSIbegandevelopingtheNHSPatientSafetystrategyin2005 incollaborationwith theAutonomousCommunityadministrations,basedoninternationalrecommendationsandthoseofSpanishexperts2.Thisstrategy,includedin the 2006 Quality Plan3 has served as a tool and framework of reference for theprocess of deploying programs and actions which have progressively been beingcarriedoutinSpainwithregardtopatientsafety.

One of themost important of this strategy’s achievementsworthy of specialmentionare thatworkingnetworksandalliancescreatedaroundpatient safetywiththe Health Regions and INGESA, (when the text refers to the Health Regionsgenerically it is understood that the INGESA included), the professionals and theirscientific societies, the patients, the academic institutions and other organizationsinterested in this subject, which has favored patient safety being included in thequality plans of the Health Regions and the dissemination of the safety culturethroughout the entire NHS. Projects have additionally been carried out which haveaffordedthepossibilityofgainingabetterknowledgeof thesafety-relatedproblemsaffectingtheNHSandthetoolsforpreventingandkeepingacheckonthem.

Thereisstillagreatdealasyettobedonetowardtrulybringingaboutachangein thecultureof theNHShealthcareorganizationsand inorder for the leaders, theclinicsandmanagementorganizationstobecomethedrivingforcebehindthischangewiththeactualactiveinvolvementofthepatientsandtheircaregivers.

Thepatientsafetystrategypresentedhereincontinuesalongthesamelineasthatwhich has been being carried out to date, retaining the same strategic lines of

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action and incorporating new objectives and recommendations regarding aspectspending furtherdevelopment. Theprocessofpreparing this strategyhas taken intoaccount: the current recommendations of the international organizations, the dataavailable from ten years of having carried out the patient safety strategy, theinformation and opinions provided by the scientific coordinators for the currentstrategy, the Health Regions, the health care professionals (through the scientificsocietieshavingwishedtocollaborate), thepatients (throughtheNHSCitizenHealthSchools Network) and other experts consulted. This strategy is the consensus onpatient safety of those mainly involved in the quality of the care provided by theNationalHealthSystem.

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TECHNICALNOTE

Thisdocumentiscomprisedofeightperfectlywell-definedparts.

1. General aspects dealing with the justification of the Patient Safety Strategy, itspurposes, the targetpopulationand thesituationanalysis setoutbywayof themagnitude and impact of the harm associated with the process of health carebeingprovided, inconjunctionwith the interventionscarriedoutat thenationalandinternationallevel.

2. Strategy lines maintaining the basic principles of the patient safety strategyalready in the process of being carried out, incorporating objectives and newrecommendations, on the basis of the assessment made as to the process ofcarrying out the strategy per se, the international recommendations and theopinionsofexperts,professionalsandpatients:

• Line1:Patientsafetyculture,humanandorganizationalfactors

• Line2:Safeclinicalpractices

• Line 3:Managementof the risk involved and systems for notificationandlearningfromtheincidents

• Line4:Participationofthepatientsandcitizensfortheirsafety

• Line5:Researchinpatientsafety

• Line6:Internationalparticipation

3. Evaluation including a brief description of the components of the evaluation ofthisstrategywhichwillcompriseaseparatedocument.

4. Glossary of the terms used in the text related to the safety and quality of thehealthcareprovided.

5. Abbreviationsandacronyms

6. Listoftables

7. Listoffigures

8. Bibliography

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1.GENERALASPECTS

a.Justification

Patientsafety,akeydimensionofqualityofthehealthcare,involvescarryingoutstrategiesforreducingallunnecessaryharmtopatientsassociatedwithhealthcare.

The 1999 American Medical Institute report4 led to several governments andinternationalhealthcareorganizationsmakingpatientsafetyoneoftheirhealthpolicypriorities. Hence, the World Health Organization launched the “Alliance for PatientSafety”in2004,promotingactions,toolsandrecommendationsforfurtherenhancingthesafetyinallcountriesworldwide5.In2006,theCouncilofEuropeurgedcountriesto develop policies, strategies and programs for further enhancing patient safety intheir health care organizations6. In June 2009, the European Council launched the“CouncilRecommendationsonpatientsafety,particularlypreventingandcombattinghealthcare-associatedinfections”7.

Inkeepingwiththeinternationalrecommendations,theMSSSImadethedecisionin 2005 to carry out a patient safety strategy for the NHS in collaborationwith theHealthRegions, respecting and further roundingout the actionswhich are currentlybeingcarriedouttherebyintheexerciseoftheirauthoritiesintheprovisionofhealthcareservices.

Theobjectivesof thisstrategyhavemainlybeenaimedat furtherenhancingthepatient safety culture and health care risk management, the training of theprofessionals, the implementation of safe practices, the active involvement of thepatientsandcitizensandinternationalparticipation.

Theepidemiologicalstudiescarriedoutwithintheframeworkofthisstrategyandthedata from theevaluationof theprogramsandactionspromotedat thenationalandregionallevelaffordprecisevalidknowledgeastothedegreeofpatientsafetyintheNHS2.

Aftertenyearsofcarryingoutthisstrategy,thisupdateisbeingsetoutasatoolfor facilitating the process of analyzing, thought being given to and decisions beingmadeon thebasis of a consensus reached concerningPatient Safety for theNHS inaccordancewiththenewneedssetoutandtakingthecurrentsituationintoaccount.

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Thestrategypresentedhereinisfocusedalongthesamelinesastheprecedingone, and the strategic lines of action proposed are based on the work previouslycarriedout in theNHSaswellason thecurrent international recommendationsandneedsdetectedbytheHealthRegionsandotherpartieswhohavean interest inthissubject.

b.Purposeofthestrategy:mission,visionandoverallobjective

Vision:

This strategy is aimed at being a reference point element for the furtherenhancementofpatientsafetyintheNHS,takingintoaccounttheevidenceavailablefrom the recommendationsmade, the feasibility of their implementation, aswell astheequityandsustainabilityofthesystem.

Mission:

Setting objectives and making recommendations aimed at minimizing the risksinvolvedintheprocessofprovidinghealthcareandreducinghealthcare-relatedharm.

OverallObjective:

Further enhancing patient safety at all levels in all settings in which care isprovidedintheNationalHealthSystem.

c.Targetpopulation

This strategy targets all patients and citizens for whom health care is providedwithin the NHS, the professionals (both clinical and managerial), the health careorganizationsandprovidersintheNHSandallthoseacademicinstitutionsandagentsinvolvedinfurtherenhancingpatientsafetyinSpain.

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d.Situationanalysis

i. Magnitudeandimpactofhealthcare-relatedharm

Ø Frequencyofadverseevents

Different epidemiological studies published as of the 1990’s havemade amajorcontributiontowardascertainingthemagnitude, impactandcharacteristicsofhealthcare-relatedadverseevents8,9,10,11,12,13,14,15,16,17,18,19,20..Thedifferentobjectivessetandthe different methodologies employed in these studies are the reason for thedifferencesfoundinthefrequencyofadverseevents(Fig.1).

A systematic review of the year 2008 revealed the average incidence ofhospitalization-related adverse events to have been 9.2% (95% CI: 4.6% – 12.4%), atotalof43.5%(95%CI:39.4%–49.6%),ofwhichcouldhavebeenprevented.Atotalof7% of the adverse events identified could lead to a permanent disability, and 7.4%could be directly related to the patient’s death21. Despite harm apparently beingcaused infrequently to patients, some experts point out that this data may beunderestimated,giventhatthesestudiesdonotincludetheadverseeventsfollowingdischargefromhospital22.Ontheotherhand,someexpertsalsorecommendtheneedofusingdifferentmethodologies soas tobeable tobetterdetect theoccurrenceofadverseevents23.

In the European Union, the frequency of adverse events among hospitalizedpatients is within the 8% - 12% range24, one death being caused for every 100,000inhabitantsperyearasaresultofsaidadverseevents,meaningaround5,000deathsper year. Nevertheless, it seems that these figures could also be underestimated,becausetheyarebasedondatarecordedbytheprofessionals25.

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Fig.1.Listofstudiesconductedforthepurposeofascertainingtheincidenceofadverseeventsinhospitals

The starting point for ascertaining the magnitude and the determining factorsinvolved in healthcare risk in Spain have been the ENEAS15, APEAS26, EARCAS27 andSYREC28 studies promoted by the MSSSI. The EVADUR29 study carried out by theSpanish Society for EmergencyMedicinehas alsoprovideduseful information in thefieldofemergencycare.

– National Study on Hospitalization-Related Adverse Events (ENEAS Study): Aretrospectivestudyofacohortof5,624patientshospitalizedat24publichospitalsinSpain formore than24hours anddischargedwithin the June4-10, 2005period (allinclusive). A total of 42,714 days of hospital stays were studied. The incidence ofpatientswith adverse events related to the care providedwas of 9.3% (525/5,624),(95%CI: 8.6% -10.1%). The incidence density was of 1.2 adverse events per 100patients/day (95%CI1.1–1.3). Theactual incidenceofpatientswith adverseevents

NewYork

(30,19

5)

Utah/Col

(14,70

0)

Australia

(14,17

9)

Australia

adjusted

NewZealand

(6,579)

U.K.(1

,014)

Denm

ark

(1,097)

Cana

da

(3,745)

Spain

(5,624)

France

(8,754)

Netherland

s(7,926)

Swed

en

(1,967)

Brazil

(1,103)

Tunisia

(602)

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relateddirectly to thehospital care (not including those referred fromprimary care,externalofficesandcausedatanotherhospital)wasof8.4%(473/5,624),(95%CI:7.7%-9.1%).Addedtotheactualincidencearethosecasesinwhichanadverseeventhadbeenthereasonforadmissiontohospitalinordertooffsettosomedegreethelossesforpost-dischargeadverseevents.

A total of 37.4% of all adverse events were related to the medication, whilstnosocomial infectionsof any type totaled25.3%and25%were related to technicalproblems during a procedure. A total of 45% (n=295) of the adverse events wereconsideredmild,38.9%(n=255)moderateand16%(n=105)severe.Inall,42.8%oftheadverseeventswereconsideredpreventable15,30,31,32.(Table1).

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Table1.MainENEASStudyDataTypes of adverse events N % Preventable

Care-related 50 7.63 56.0

Pressure ulcer 24 3.66 Burns, scrapes and contusions (including consequent fractures) 19 2.90

Acute pulmonary emphysema and Respiratory failure 4 0.61 Other consequences of extended bedridden situation 3 0.46

Medication-related 245 37.4 34.8

Nausea, vomiting or diarrhea secondary to medication 32 4.89 Itching, rash or skin irritations reactive to drugs or bandages 32 4.89

Other drug side effects 29 4.43 Uncontrolled glycaemia 19 2.90

Hemorrhage due to anticoagulation 18 2.75 Others 104 15.89

Nosocomial infection-related 166 25.34 56.6

Surgical wound infection 50 7.63 Nosocomial urinary tract infection 45 6.87

Other type of nosocomial infection or an unspecified nosocomial infection 22 3.36 Sepsis and septic shock 19 2.90 Nosocomial pneumonia 17 2.60

Device-related bacteremia 13 1.98 Procedure-related 164 25.04 31.7

Hemorrhage or hematoma related to surgical intervention or procedure 61 9.31 Injury to an organ during a procedure 20 3.05

Other complications following surgical intervention or procedure 14 2.14 Ineffective or incomplete surgical procedure 11 1.68

Uterine rupture 9 1.37 Others 49 7.48

Diagnosis-related 18 2.75 84.2

Delayed diagnosis 10 1.53 Diagnostic error 8 1.22

Others 12 1.83 33.4

Pending being specified 7 1.07 Other adverse events 5 0.76

Total 655 100.00 42.6

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– Study on patient safety in primary care (APEAS Study): A prevalence studyconducted on an opportunity sample from 48 primary care centers in 16 HealthRegions, inwhich452professionals tookpart.A studywas conductedof the96,047patientswhocameinforappointmentsoverthecourseofatwo-weekperiodinJune2007.

Theobservedprevalenceofadverseeventswasof11.18‰oftheprimarycareconsultations(95%CI:10.52–11.85).Theprevalenceofpatientshavingsomeadverseeventwasof10.11‰(95%CI:9.48–10.74).Atotalof6.7%ofthepatientshadmorethan one adverse event. A total of 54.7% (n=606) of the adverse events wereconsideredmild,38.0%(n=421)moderateand7.3%(n=81)severe.

A total of 47.8%of the adverse events (n=530)weremedication-related, 8.4%(n=93)involvinghealthcare-associatedinfectionsofanytype,atotalof10.6%(n=118)beingrelatedtosomeprocedureand6.5%(n=72)tothecareprovided.

Themajority of the adverse events (64.3%)were considered preventable, andsolely5.9%weresevere,themajoritybeingmedication-related33,34.

– Adverseeventsatsocialhealthcentersandnursinghomes(EARCASStudy):Aqualitativestudyconductedinseveralstagesaimedaavailingofaninitialapproachtopatientsafetyinaverage-length-of-stayandextended-stayhospitalsandsocialservicesinSpain,inwhichmorethan950expertsfromnearly100centersandinstitutionsfromallofSpain’sHealthRegionstookpart.

Accordingtothestudyfindings,themostcommonincidentsandadverseeventsarerelatedtothecareprovidedtothepatients,theuseofmedicationandhealthcare-associated infections.Themostoutstanding factorswhichcontribute to theonsetoftheseincidentsandadverseeventsarethoserelatedtothepatient’svulnerability.

Themagnitudeofthisproblem,setoutinthestudyfindings,revealstheneedforidentifyingandcarryingoutstrategiesforfurtherenhancingpatientsafetyinthesocialservicesandmedicalcaresettings27.

– Incidentsandadverseeventsinintensivecaremedicine.Safetyandriskinthecritical patient (SYREC Study):A prospective cohort study conducted on 79 Spanishintensive careunitsbasedon the reportingof incidentsby theprofessionalsproper.The risk of experiencing a harmless incident as a result of being admitted to anintensive care unit, given as a median figure, was of 73%, and a 40% risk ofexperiencing an adverse event. The adverse eventswhich occurredmost frequently

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werethoserelatedtocareprovidedandhealthcare-associated infections.A totalof90% of all the harmless incidents and 60% of the adverse eventswere classified aspreventableorpossiblypreventable35.

– Adverse events linked to the care provided in Spain’s hospital emergencyservices (EVADUR Study):A prospective study conducted on 21 emergency serviceswithintheOctober–December2009period.Thehealthcareprovidedtoasampleof3,854patientswasfollowedoverthecourseofaseven-dayperiod.Atleast12%ofthepatients forwhom carewas provided in an emergency servicewere affected by anincident, and 7.2% experienced an incident involving harm. Evidence was found ofimproper action in 54.6% of these cases. The factors associated with the incidentswere related to the use of medications, delayed diagnosis and breakdown incommunication.Atotalof70%oftheadverseeventswereconsideredpreventable29.

Table 2 provides a summary of the characteristics andmain findings of thesestudies.

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Table2.Spanishstudiesonthefrequencyofadverseeventsindifferenthealthcare-providingsettings

Study Yeardatacollected Typeofstudy Scope TotalAEs

(%patients) MostfrequentAEs %ofAEspreventable

ENEAS15 2005Historiccohorts

24Hospitals 9.3%Medication(37.4%)

HAIs(25.3%)Procedures(25%)

50%

APEAS26 2007 Prevalence 48PrimaryCareCenters 10.11‰

Medication(47.8%)Baselinedisorderevolvedfortheworse

(19.9%)Procedures(10.6%)

70%

EARCAS27 2010-2011 QualitativeSocialservicesmedicalservicescentersand

livingfacilities--

Care,Medication

HAIs ---

SYREC28 2007Prospectivecohorts

79ICUs/76Hospitals 33.1%

Care(26%)HAIs(24%)

Medication(12%)60%

EVADUR29 2009 Prospective

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EmergencyServices 7.2%Care-providingprocess(46.2%),

Medication(24.1%)Procedures(11.7%)

70%

-ENEAS:NationalStudyonHospitalization-RelatedAdverseEvents-APEAS:StudyonAdverseEventsinPrimaryCare

-EARCAS:AdverseEventsatSocialServicesMedicalServicesCentersandLivingFacilities-SYREC:SafetyandRiskintheCriticalPatient

-EVADUR:AdverseEventsinEmergencyCare-AE:Adverseevent.–HAIs:Healthcare-associatedinfections

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According to the results of these studies, it can be said that the incidence ofadverse events related to the careprovided and the spreadby categories in Spain’shospitals is similar to that of the studies conducted in American and Europeancountriesemployingasimilarmethodology.TheENEASStudyservedtomakefollowingthe recommendations based on evidence a strategic priority on theNHS agenda, todisseminate best practices and to put the available knowledge into practice as aguarantee of clinical safety. The APEAS study served the purpose of revealing that,althoughthefrequencyofadverseeventswaslowandseveretoonlyascarcedegreeattheprimary level,themulti-causaletiology,thehighprobabilityofpreventionandtheexistinghighdegree towhichprimary care is frequentedwarrantedundertakingactionsaimedatfurtherenhancingpatientsafetyatthiscare-providinglevel.

Ø Citizenopinions

Atotalof53%ofallEuropeanUnioncitizensareoftheopinionthattheycouldbeharmedonundergoinghospitalcare(40%inoutpatientcare).Additionally,atotalof27% of those surveyed (23% in Spain) stated that either they themselves or theircaregivershavebeenharmedatsometimeintheprocessofhospitalcare36.

In Spain, the Health care Barometer conducted in 2010 revealed that 11.7% ofthose surveyed reported either they, themselves, or their caregivers havingexperienced an error during the consultation with the specialist, 11.5% during ahospitalstay,9.6%inaprimarycareconsultationand8%intheemergencyservices37.

Ø Thecostofadverseevents

Inviewofthedifficultyofassessingthecostoftheharminvolvedinprovidinghealth care and the savings entailed on implementing patient safety programs, arecent publication suggests several tools for assessing the costs associated withadverseeventsandthecost-effectivenessofthepracticesfortheirprevention38.

InSpain,twoarticlespublishedareworthyofspecialmention.Thefirstarticleestimatesthatthecostsofunsafenessrelatedtomedication,nosocomialinfectionandsurgicalproceduresinhospitalizedpatientsin2011hasentailed2.474millioneurosforSpain’sNationalHealthSystem39.ThisarticlebasedonthestudyofcostsofunsafenessconductedbytheMSSSI in200840,forwhichtheresultsasperthehospitalrevenuesandtheConsumerPriceIndexfor2011wereupdated.Thesecondarticleevaluatestheeconomic impactof the incidenceofadverseeventsonhospitalcare inSpainonthebasis of the data at discharge from hospital of patients for whom care has been

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provided bymeans of admission to the hospitals belonging to the Spanish HospitalCostsNetworkduringthe January1,2008–December21,2010period.The findingsshow the total incremental costs of the adverse events to be 88,268,906 €, anadditional6.7%addedontothetotalhealthcarespendingfigure41.

Inshort,afternearly tenyearsofworkingonpatientsafety inSpain,wecansaythat:

a) Sufficient knowledge exists regarding the frequency and distribution of theadverseevents,aswellasthecontributingfactorsinallareasofhealthcare:acute hospitals, intensive care, emergency care, average-length-of-stay andextended-stayhospitalsandprimarycare.

b) Around9-12%ofthepatientsforwhomcareisprovidedinhospitals,bothinhospitalizationandemergencycare,and1.2%ofthepatientsforwhomcareisprovidedatprimarycarecentersexperiencesomeadverseeventrelatedtothecareprovided.These figuresare similar to those found toexist inothercountries.

c) Thepercentagesofpreventability,weretheavailableknowledgetobeputintopractice,areofmajorimportance,rangingfrom50%to70%dependingonthetypeofadverseeventandcare-providingsettinginquestion.

d) Moderatetohigh-qualityevidenceexistsastotheimportanceandusefulnessof implementing safe practices and procedures. Very little research hashoweverbeendoneontheimplementationandevaluationofthesepractices.Inotherwords:weknowwhatshouldbedone,butwedon’tknowifwearedoingsototheextentitshouldbedone42.

e) It is estimated that the costs resulting from adverse events and theopportunitiesmissedasaresultofnotdoingwhatshouldbedoneadduptoamajorpercentageofhealthcarespending.

f) In short, theadverseevents related to thehealthcareprovidedareapublichealth problem due to their magnitude, far-reaching importance andpreventability.

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ii.Interventionscarriedoutattheinternationallevel

Patient safetyhasalwaysbeena focalpointof theattentionandeffortsof thehealth care professionals and institutions 43, although the importance thereof wasparticularlybroughttoforeasofthereport“ToErrIsHuman:BuildingaSaferHealthcareSystem”,publishedin1999bytheU.S.MedicalInstitute4.Thisreportservedasaguide for themain international health care organizations for developing strategiesand recommendation for cultivating the control of the preventable harm in healthcare.

INTERNATIONALORGANIZATIONSINTERESTEDINPATIENTSAFETY

Some of themost outstanding international organizations interested in patientsafetywhichhavehadthegreatestinfluenceonSpain’ssafetypoliciesinparticulararethe World Health Organization, the Pan American Health Organization, theOrganization forEconomicCooperationandDevelopment, theEuropeanCouncilandtheEuropeanUnioninstitutions(particularlytheEuropeanCommission).

� WorldHealthOrganization(WHO)

In2004, theWorldHealthOrganization launchedtheWorldAlliance forPatientSafety, currently referred to as the Patient Safety Program,which includes differentchallenges and actions for further enhancing patient safety at the worldwide level,someofthemostoutstandingofwhichare:

o Challenges:

Programsdealingwithsignificantrisksforthepatientsforwhomcareisprovidedwhich are relevant for all of the countries pertaining to the World HealthOrganization:

– Clean care is safer care44. Its top-priority objective is to assure thatimprovinghandhygieneisontheagendaofthehealthcareorganizationsforpromotingthepreventionofhealthcare-associatedinfectionsandtheirconsequences.

– Safe surgery saves lives45. This program revolves around the surgicalchecklistasatoolforfurtherenhancingsafetyinsurgery.

– Combatting antimicrobial resistance46. Third challenge launched by theWorld Health Organization in 2010 for promoting the reasonable use ofantibiotics in humans, in veterinary medicine and agriculture and

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promoting research in this field. As of May 2014, the World HealthOrganization undertook the commitment of developing a global plan foraction formeeting the challengewith resistance toantibioticsmeans forhumanhealth47.

o Mainactions:

Someofthemainactionsworthyofspecialmentionare:

– Patientsforpatientsafety.AimedatcreatingaPatientsandConsumersforPatientSafetyNetwork48.

– Reportingandlearningsystems49.– Knowledgemanagement50.

– Safeclinicalpractices51.

InFebruary2012,theWorldHealthOrganizationpromotedameetinginGenevaonSafetyinPrimaryCareforthepurposeofanalyzingthedataavailableonfrequency,characteristics and possibilities of prevention and severity of adverse events and toassess the challenges in view of a situation of economic crisis and the possibility ofsettingupcommonstudiesamongcountries52.Theparticipantsplacedtoppriorityona number of recommendations for further enhancing patient safety in primary care(Table3).

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Table 3. Top-priority recommendations for further enhancing patient safety in primarycare

Top-priorityrecommendationsinprimarycare

Trainingtheprofessionalsinpatientsafety

Promotingpatientsafetystudiesemployingdifferentmethodologies

Developingpoliciesforpromotingpatientsafetyinprimarycare

Improvingthedefinitionsconcerningerrorsandtheirclassification

Facilitatinglearningfrompasterrors

Assuringthatthesystemsforfurtherenhancingpatientsafetyinprimarycareareputintopractice

On the road map to be followed, it was considered important to avail of someguidelinesonpatient safety inprimary carebypromoting a systematic focuson thesameandmakingsuggestionsforimprovementbothinthemanagementaswellasthecare-providingaspects.

The World Health Organization promoted the study Prevalence of adverseevents in Latin American hospitals (IBEAS Study) carried out in collaboration withSpain’s MSSSI and five countries in the region, being the first study to have beencarriedoutona largescale inLatinAmericaformeasuringtheadverseevents inthehospitals.TheIBEASstudypositionedSpainasabenchmarkcountryinpatientsafetyintheSpanish-speakingworld53,54.

• PanAmericanHealthOrganization(PAHO)

The PanAmericanHealthOrganization has been carrying out the CareQualityandPatient SafetyProgram55within the frameworkofwhichdifferentprojectshavebeencarriedout,someofthemostnoteworthyofwhichare:

o SystemsforreportingincidentsinLatinAmericawhichtakeininformationondifferent reporting systems in the region and recommendation for theirimplementationanddevelopment.

o AdverseEventsinpatientsforwhomcareisprovidedintheoutpatientcareservicesinLatinAmerica-AMBEASStudy.Themainobjectiveofthisresearchwastoassessthefeasibilityofcarryingoutthistypeofstudiesintheregion,aswell as ascertaining the frequency, characteristics and preventability ofadverseeventsamongthepopulationunderstudy56.Thisstudywasconducted

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in response to the interest of the countries in the region in broadening theknowledgeonpatientsafetyandcomprisingpartofthestrategylinessetoutunderResolutionCSP27.R10ofOctober5,2007:“RegionalPolicyandStrategyfortheGuaranteeofQualityinHealthCare,includingpatientsafety”57.

� OrganizationforEconomicCooperationandDevelopment(OECD)

TheOrganization forEconomicCooperationandDevelopment setupaworkingsubgroup of patient safety indicators in 2007 for the purpose of developinghomogeneous indicatorsonthebasisofadministrativedatabaseswhichwouldmakeevaluationandcomparisonamongcountriespossible58,59.

AstudywasconductedwithintheSpanishscopeforthepurposeofdeterminingthe empirical validity of the PS indicators and preventable hospitalization for theevaluationofthequalityofthehealthcareproviders60.

� CouncilofEurope

The Warsaw Declaration for Patient Safety of 2006 recommended includingpatientsafetyasapriorityonthenationalandinternationalagendas,cooperatingwiththeCouncilofEurope61,theEuropeanCommissionandtheWorldHealthOrganizationforassuringtheimplementationofpatientsafetyactions.

Itrecommendedthefollowingstrategylinesbecarriedout:

– Promotingapatientsafetyculturewithasystematicfocus

– Settingupincidentreportingsystemsforlearninganddecision-making

– Getting thepatients and citizensactively involved in furtherenhancingsafety

� EuropeanUnion(EU)

– European Commission. For the purpose of providing the population

withahighdegreeofhealthprotection62andsupportingtheMemberStates in achieving safe health care, the European Commission hascarriedoutdifferent actions, coordinatingor supporting theactivitiesand projects in which the Member States, the professionals andpatientsandmostoftheorganizationsandinstitutionswhichhaveaninterestinthissubjecthavetakenpartorarecurrentlytakingpart.

– LuxembourgDeclarationonPatientSafety.ADeclarationwhicharoseoutofaconferenceorganizedduringLuxembourg’spresidencyof the

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EuropeanUnion,withtheslogan:“PatientSafety–MakingitHappen!”IncludingspecificrecommendationsonpatientsafetyattheEuropeanUnion,nationalandlocallevels63.

– QualityandPatientSafetyWorkingGroup.AGroupworkingundertheHigh-LevelGrouponHealth Services andMedical Care and set upbyway of a European Commission decision in April 2004. This groupcontributed considerably to the proposal of the Council of theEuropeanUnionRecommendationsonpatientsafetyandhealthcare-associated infections. This group serves as a platform for sharinginformation on actions underway, priorities and innovative solutionswith a view to the EuropeanUnion’s patient safety and care quality-relatedchallenges.ThisgroupiscomprisedofrepresentativesfromtheEuropean Commission, the Member States, the World HealthOrganization, the Organization for Economic Cooperation andDevelopmentandotherinterestedparties64.

– Joint actions of the Member States. Most of the European Unioncountries have been working together on two consecutive projectsfundedbywayoftheEuropeanUnionpublichealthprogram.

o EuropeanUnionNetwork for Patient Safety: EUNetPaS.Carriedout within the 2008-2010 period for the purpose of promotingnetworksforcollaborationinpatientsafetyforsharingknowledgeandexperiencesatthenationalandEuropeanUnionlevels65.

o EuropeanUnionNetworkforPatientSafetyandQualityofCARE:PaSQ. Joint action between the European Commission and theEuropean Union countries aimed at promoting theimplementation of the Council of the European Unionrecommendations, promoting the sharing of knowledge andexperiences in the field of patient safety and care quality andfavoring a sustainable collaboration network in the EuropeanUnionrevolvingaroundcarequalityandpatientsafety66.

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– Recommendationsof theCouncil of theEuropeanUnion concerning

patient safety, including prevention and control of health care-

associatedinfectionsofJune2009.

ThisRecommendationiscomprisedoftwochapters7:

• Thefirstchapter,devotedtopatientsafety,makesreferencetoanumberofrecommendations,includingthedevelopmentofnationalpolicies,patienttraining,settingupadverseeffects-relatedinformationand learningsystems, thepromotionof theeducationand trainingofhealth care workers and carrying out research. It also invites theMember States to share patient safety-related best practices andknowledge.

• The second chapter, devoted to health care-associatedinfections, recommends that theMember States adopt a strategy forthe prevention and control of health care-associated infections andthat they set up an intersectorial mechanism for the coordinatedimplementationofthisstrategy(measuresatthenationalandregionallevel and at the level of the health institutions: surveillance systems,education and training of professionals and patients, in addition toresearch).

In 2012, the European Commission published an executive reportaddressing the Council on the implementation of these recommendations,based on the answers given by the Member States on a standardizedquestionnaire.Theactions recommendedhadnotbeen fully implementedbyall of the countries, a further one-year time frame therefore having beenallowedfortheimplementationthereof.

Spainwas one of the countrieswhich had implemented 10-12 of thetotal13patientsafety recommendationsmade67. In June2014, theEuropeanCommissionmadeasecondconsolidatedreportontheimplementationoftheCouncilRecommendationsonpatient safetypublic 68. Inviewof the findings,theCommissionsets forthseven(7)suggestedareasat theendof thereportforworkingincollaborationwiththeMemberStates(Table4):

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Table4.AreasforworkingonpatientsafetysuggestedbytheCounciloftheEuropeanUnion

Areas for working on patient safety suggested by the European Commission

1. Collaborating fordevelopinga commondefinition regarding carequality andprovidinggreater support for the development of common indicators and terminology in patientsafety.

2. Collaborating at the European Union level on the subject of patient safety and carequalityforsharingbestpracticesandeffectivesolutions.ThiscouldbebasedoncontinuingthejointPsSQactioncurrentlyunderwayandextendingittoothersubjectsidentifiedbytheMemberStatesandtheinterestedparties.

3. Preparingguidelinesastohowtoprovidepatientswithcarequality-relatedinformation

4. DevelopingamodelinconjunctionwiththeMemberStatesconcerningstandardsofcarequality and patient safety for the purpose of achieving a better shared understanding oftheseconcepts.

5. Promoting, in conjunctionwith theMember States, transparent information regardingcomplaintandcompensationsystems,asisrequiredundertheDirectiveonpatientrightsincross-borderhealthcare69.

6. Cultivatingtrainingbeingcarriedoutforthepatients,familiesandcaregivers,employingtools from information technology and periodically updating and disseminating therecommendationsoneducationandtraininginpatientsafetyforhealthcareprofessionals70.

7. Cultivating the reportingprocessasa tool fordisseminating thepatient safety culture;periodic updating and dissemination of the recommendations concerning starting up andoperatinganincidentreportingsystemforlearningpurposes71.

– Directiveonpatient rights incross-borderhealthcare.Thisdirective isaimedat

clearlysettingoutpatientrightsonaccessinghealthcareinanothermemberstateandtherefundingthereof;aidingtowardmakingwell-informeddecisionsbasedonthe informationprovidedonqualityandsafetyby thehealthcareproviders;andguaranteeingcooperationamongtheMemberStatesinthepatients’interest69.

ThisdirectiveenteredintoeffectinOctober2013andwastransposedintotheSpanishlegalsystembywayofRoyalDecree81/2014ofFebruary7,201472.

– EuropeanReferenceNetworks.WithinthecontextoftheCross-borderHealth

Care Directive and with the unanimous support of the Member States, theEuropean Commission approved the legal basis for the implementation ofreference networks aimed at further enhancing access and knowledge formanagingrareorhighlycomplexdiseases,includingawide-ranginglistofcare

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quality and patient safety-related criteria with which the highly-specializedmedical services centers in the European Unionmust comply in order to beapprovedasmembersofthenetwork73,74.

– The Council’s conclusions on care quality and patient safety: In 2014, theCouncil of the European Union approved some conclusions on this subject,underlining the importance and priority of the patient safety-related policiesandsettingoutthecommitmentofthecountriesastocontinuingworkingonsaid policies, entrusting to the European Commission the organization of apermanent platform for providing sustainability for the joint action and thesharingofbestpracticesamongtheMemberStates75.

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INTERNATIONALSTRATEGICLINESOFACTIONINPATIENTSAFETY

The international strategies forpatient safetyare focusedmainlyon twomajorareas: the cultural change of the professionals and the implementation of safepractices.

� Patientsafetyculture,humanfactorandtraining

Ascertaining an organization’s patient safety culture is the first step toward itsfurtherenhancement.Thesafetyculture-relatedresearchhasbeenfocusedmainlyonevaluating the safety climate (the safety-related attitudes and perceptions of theprofessionals) and their association with different clinical outcomes, as well as thesatisfactionofbothprofessionalsandpatients76.

Although no clear-cut evidence currently exists concerning the relationshipbetween the safety cultureand thepreventionof adverseevents, some studies findthere to be a correlation between a positive safety climate and a betterimplementationofsafepracticesandbetterclinicaloutcomes77,78.

Theorganizationscommittedtothesafetyculturefocustheireffortsonfourkeyaspects: cultivating the safety culture at all levels; evaluating and promoting a goodsafety-related climate; increasing training in patient safety and the so-called humanfactorsornon-technicalfactorsoftheprofessionals;anddevelopingsafetyelementsattheclinicalunitlevel79.

The importance of the human factor in further enhancing patient safety hasgrown over the past few years, there currently being several experts who arerecommending training the health care professionals in this aspect and favoring theincorporation of the human factor-related principles into the organization by takinginto account physical aspects (design, equipment, etc.), cognitive aspects (theprofessional’s status and situation, communicating skills, teamwork (“from theworkteamtoteamwork”)andorganizationalaspects(theorganization’sculture)80,81,82,83.

Training in patient safety is the first step toward further enhancing the safetycultureand isan indispensableelement inorder for thehealthcareprofessionals tounderstandwhythepatientsafety-relatedinitiativesarenecessaryandhowtheycanput them intopractice. The importanceof training theprofessional is patient safetyhasbeenpointedoutbothbytheWorldHealthOrganization,whichhasdevelopedaspecific curriculum guide84 and by the European Commission, which has recentlypublishedsomerecommendationsinthisregard71.

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� Safepractices

Safe practices are those interventions aimed at preventing or mitigating thenecessaryharmassociated tohealth care and further enhancingpatient safety 42,85.Table 5 provides a brief descriptionof the safe practices recommendedbydifferentinternationalagenciesandorganizationsbasedonthefrequencyofthemostcommonadverse events and the evidence for their control. The practiceswhichmost of theorganizations recommendare thosewhichhave todowith thepreventionofhealthcare-associated infections (especially hand hygiene), safe use of medication, safesurgeryandcare.

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Table5.Safepracticesrecommendedbydifferentinternationalorganizations

AHRQEvidenceforPSP

(2013)

NQFPSPforbetterhealthcare

(2010)

JCNationalPSgoals

(2014)

WHOPatientsafetysolutions

(2007)• Handhygiene • Handhygiene • Handhygiene • Handhygiene• Medicationreconciliation • High-riskmedications • Medicationreconciliation • Medicationreconciliation

• Safesurgery • Safesurgery • High-riskmedications • CRB • CRB • High-riskmedications

(concentratedelectrolytesolutions)

• Catheter-relatedUTI • Catheter-relatedUTI • Safesurgery • Surgicalinfection • Surgicalinfection • CRB • VAP • Identification • Catheter-relatedUTI • Safetyculture • Communication • Safesurgery• VAP • Medicaldevices • Identification• Safetyculture • Informedconsent • Caretransition• Medicaldevices • Caretransition • Similarly-namedmedications• Caretransition • Antimicrobial(drug)resistance • Pressureulcers • Pressureulcers • Falls • Falls • Activepatient/caregiver

involvement• •

VenousthrombosisIonizingradiationinpediatrics

AHRQ:AgencyforHealthcareResearchandQuality86;NationalQualityForum87;JC:JointCommission88;WHO:WorldHealthOrganization89CRB:catheter-relatedbacteremia,UTI:urinarytractinfection;HRMs:high-riskmedications,VAP:ventilator-associatedpneumonia,RAM:resistancetoantimicrobials,PUs:pressureulcers

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� Safemedicationuse

Specialinteresthasbeenfocusedontheimportanceofmedicationerrorsonthe

part of different international agencies and organizations, which have stressed the

needofimplementingsafepracticeswhichareeffectiveforreducingtheseerrors.

– In2007,theAmericanMedical Institutepublishedanumberofrecommendations

foralloftheplayersinvolvedinthemedicationusecircuit,afterhavingpointedout

thatatleast1.5millionpreventablemedication-relatedadverseeventsoccurevery

yearintheUnitedStates90.

– TheCouncilofEuropealsopublishedareportwhichincludedathoroughreviewof

thestudiesconductedonmedicationerrorsinEurope,aswellasrecommendations

fortheirpreventionaddressedtohealthcareauthorities, institutions,healthcare

professionalsandthepharmaceuticalindustry91.

– In 2013, the European Medicines Agency organized a meeting92, with the

participation of representatives of all of the agents involved in the notification,

evaluationandpreventionofmedicationerrorsforthepurposeoffacilitatingthe

implementation of new legal provision in Pharmacovigilance in the European

Union93.

Numerous safe practices have similarly been proposed for preventing

medication errors, especially in the hospital setting. These practices involve some

major differences with regard to cost, degree of complexity for implementation,

evidenceofeffectivenessand impactonpatientsafety,different initiativestherefore

having been carried out for selecting the essential practices on which top priority

shouldbeplacedfortheir implementationonthepartofhealthcareauthoritiesand

institutions:

– InMay 2007, theWorldHealthOrganization launched ninemeasureswhich

haveshownthemselvestobeeffectiveforthepurposeofpreventingadverse

events,theimplementationofwhichisconsideredatoppriority89.Severalof

these measures are practices related to the safe use of medications:

prevention of errors due to similar-sounding or similarly-spelled medication

names, control of concentrated electrolyte solutions and medication

reconciliationatcare-providingtransitions.

– In 2013, the Agency for Health care Research and Quality published anupdatedreportontheevidenceofsafepracticesknowntodate,considering

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the evidence of their effectiveness and the cost and difficulties involved for

theirimplementation86.Fourofthe22practicesselectedhavetodowiththe

medicationarea (settingout a list of abbreviationswhichmustnotbeused,

incorporatingclinicalpharmacistsonthecare-providingteams, implementing

assistedelectronicprescriptionandreconcilingmedication).

– In 2010, theNational Quality Forum published an update of 34 top-prioritysafetypracticesforpreventingcare-providingerrors,groupedinto7functional

categories87, including several practices related to the prevention of

medicationerrors(incorporatingassistedelectronicprescription,verifyingthe

verbal prescriptions, limiting the use of abbreviations, medication

reconciliation, implementing standardized procedures with the high-risk

medications,maintainingriskmanagementprograms,etc.)

– The Joint Commission set out theNational Patient Safety Goals as of 2003whichareobjectivesaimedatpromotingthepreventionoferrorsindifferent

areas in theaccredited institutions88.Theseobjectivesare reviewedannually

andaremaintainedor replaceddependingonwhateverprioritiesmayarise.

The objectives related to the system for use of medications have revolved

around further enhancing the identification of the patients, standardizing

abbreviations, controlling the high-riskmedications, reducingmedications of

similar names being confusedwith one another, properly labeling all of the

medications which are prepared, avoiding free-flow infusion pumps,

reconcilingmedicationsandfosteringtheactiveinvolvementofthepatientsin

theirtreatment.

� Healthcare-associatedinfections

In hospitals, the prevalence of health care-associated infections falls within the

5.7%-19.1%range,withanoverallprevalenceof10.1%.Inthedevelopedcountries,

health care-associated infections affect 5%-15% of all hospitalized patients94. In

Europe,thisprevalencefallswithinthe3.5%-14.8%range,thusmeaningthataround4

millionpeopleperyearareaffectedbyhealthcare-associated infectionsduringtheir

hospital stay, causing 37,000 deaths, 16 million extra days of hospitalization and

approximatelyseventrillioneurosindirectcosts67,95.

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Healthcare-associatedinfectionsareoftendifficulttotreatduetotheinvolvement

of microorganismmultiresistant to antibiotics, but the evidence shows that around

50%canbepreventedbywayofsafepractices.Therefore,preventingandcombatting

theseinfectionsandresistancetoantibioticsisakeypriorityfordifferentinternational

organizationssuchastheWorldHealthOrganization,theEuropeanCenterforDisease

PreventionandControlandtheEuropeanCommission24.

– TheWorldHealthOrganizationtookuponitselftospearheadthepreventionofhealthcare-associatedinfectionsbywayofitsfirstchallenge“Cleancareissafe

care”44 one of the main components of which was its worldwide campaign:

«Save Lives: Clean YourHands”, aimed at further enhancing the hand hygiene

practices of health care personnel. A person’s hands are the main means of

transmission of the microorganisms causing health care-associated infections,

handhygienecomprisingthesimplest,cheapest,mosthighlyeffectivemeansof

reducingtheseinfections.However,accordingtovariousstudies,thismeasureis

notbeingfollowedbymorethan40%96.Theimplementationofthemultimodal

strategy for further enhancing hand hygiene promoted by the World Health

Organizationisapparentlyimprovingcompliancewithachievingahigherdegree

of hygiene and reducing the rate of multiresistant microorganisms such as

Methicillin-ResistantStaphylococcusAureus(MRSA)andClostridiumdifficile97,98.

The objective of World Hand Hygiene Day, held every May 5th, is to

heightenawareness about theneedof health careprofessionals implementing

the hand hygiene practice at the fitting point in time and in the appropriate

manner (by following the five moments recommended by the World Health

Organization) for the purpose of contributing to reducing the spread of

potentiallylethalinfectionsatmedicalservicescenters.

– TheEuropeanCommissionhasalsobecomeactivelyinvolvedincombattingHAIs

bymeansofdifferent actions and strategies, someof themostoutstandingof

whichare:

¡ The Council of the European Union Recommendation7 on patient safety,

particularlypreventingand combattinghealth care-associated infections. In

thisRecommendation,theMemberStatesareaskedtoadoptandimplement

a strategy for preventing and combattinghealth care-associated infections,

mention being made of a “Plan for action against the growing threat of

bacterialresistances”,whichincludestwelveactionsthatmustbecarriedout

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by the European Union countries, one of which is the action for

“strengtheninginfectionpreventionandcontrolinhealthcaresettings”.

The latest report published by the European Commission on the

implementationoftheaforesaidrecommendations67invitestheMemberStates

to focus their efforts on monitoring the infections, especially surgical site

infectionandthosecausedonintensivecareunitsandatsocialservicesmedical

services centers. Mention is also made therein as to the need of preparing

national diagnostic guides, setting out actions for continued training of health

care professionals, implementing the definitions of health care-associated

infections and the further enhancement of the diagnostic capabilities of

laboratories.Asapriority,itisrecommendedtoassure:

– A sufficient number of trained professionals devoted to the control of

healthcare-associatedinfectionsatthemedicalservicescenters.

– Capacity for putting precautions into place for isolating hospitalizedpatientsinfectedwhoareshowingrelevantclinicalsignsandsymptoms.

– Standardized surveillance of the consumption of alcohol-based products

forhandhygiene.

TheCommissionhasfundedseveralprojectsonaEuropeanscalewithinthe

frameworksofthe2003-2008and2008-2013HealthPrograms,theobjectivesof

whicharedetailedinTable6.

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Table6.EuropeanUnionandECDCinitiativesforcombattingHAIsandAMR

Project Objectives

HELICS To set up a standardized health care-associated infection surveillance system and databases (surgical site infection and infection on intensive care units) at the European Union level for pinpointing areas for improvement.

IPSE Reducing the burden of health care-associated infections and the challenge of resistance to antibiotics by developing recommendations, training tools and control indicators.

BURDEN Generating adequate knowledge and awareness among policymakers and society as a whole concerning the social dimension of health care-associated infections and resistance to antibiotics by providing valid, comparable information on the load of morbidity and the costs attributable to these problems in the European Union.

IMPLEMENT Identifying strategies at the individual hospital and country level for reducing health care-associated infections and resistance to antibiotics.

PROHIBIT Analyzing the guidelines and practices currently in effect for the prevention of health care-associated infections, the facilitating factors and barriers for full compliance with the best practices and the effectiveness of the interventions of known effectiveness.

HELICS:HospitalinEuropeLinkforInfectionControlthroughSurveillance99.

IPSE:ImprovingPatientSafetyinEurope100.

BURDEN:BurdenofResistanceandDiseaseinEuropeanNations101

IMPLEMENT:ImplementingStrategicBundlesforInfectionPrevention&Management102

PROHIBIT:PreventionofHospitalInfectionsbyInterventionandTraining103

HAIs-.Healthcare-associatedinfections

AMR:Antimicrobialresistance

ECDC:EuropeanCenterforDiseasePreventionandControl104

In2010,atrans-AtlanticcollaborationwascarriedoutbetweentheEuropean

UnionandtheUnitedStatesaimedatcombattingresistancetoantibiotics.105.The

recommendations resulting from this collaboration have to dowith the need of

creating indicators of structure and process for the use of antibiotics, for use in

bothhumans and in veterinarymedicine, to develop toolswhichwill aid toward

changinghabitsintheiruse,improvinginformationonthebasisofepidemiological

studies, harmonizing the criteria for the interpretation of resistance among the

European and American laboratories, reaching a consensus as to the prevention

tools for thehospital controlprograms,preparinga joint inoculation strategy for

45

preventing health care-associated infections, stimulating the creation of new

antimicrobialdrugsand,ingeneral,sharingtheeffortsandknow-howinthisarea.

– TheEuropeanCenterforDiseasePreventionandControl:ECDCwhichcoordinatesEuropean surveillanceof surgical infections, infectionson

intensive care units and the resistance to antimicrobial drugs,

developed a protocol in 2009 for studying the prevalence of health

care-associated infectionsand theuseofantimicrobialdrugs inacute

hospitalswhichwasputintopracticeintheMemberStatesthroughout

the 2011-2012 period104. The ECDC additionally supports a European

network for health care-associated infection surveillance at the

extendedstayhospitals106.ElEuropeanCenter forDiseasePrevention

andControl sponsors thepreparationof guidelinesand indicators for

the prevention of health care-associated infections and develops

guidelines for preventing and combatting infections by Clostridiumdifficileandbycarbapenemase-producingenterobacteriaceae.

� Safesurgery

Thestudiesconductedforascertainingtheadverseeventsassociatedtosurgery

reveal that 25% of the patients having undergone surgery have experienced

complicationsfollowingsurgery(3%-16%beingmajorcomplications).Inindustrialized

countries, 3%-22% of the adverse events related to surgery at hospitals lead to

disability,involvingdeathratesof0.4%-0.8%108.

Takingthisdataintoaccountandtheactthatatleast50%ofthesurgery-related

adverse events could be prevented by way of safe practices, the World Health

Organization launched a second challenge in 2008: Safe Surgery Saves Lives45Thismultimodal program suggests working in four areas: preventing surgical wound

infection; preventing the wrong site/wrong patient/wrong procedure; further

enhancing the safety of surgical equipment; and safety in handling anesthesia The

results of an international pilot study conducted in 10 countries demonstrated the

effectiveness of the measures recommended109 especially the use of the surgical

checklist.Thislisthasalsoshownareductioninerrorswhentheyareusedinsimulated

crisissituations110.

Despitetheeffortsmade,theimplementationofthesurgicalchecklisthasbeen

incomplete at the international level. The main barrier detected have been:

46

consideringittobeimposedbytheadministration;changeintheorganizationoftimes

onsurgicallistsandpossibledelays;notbeingfullyconvincedofitsusefulness;feeling

of duplicating tasks; lack of adaptation of the list to the center’s circumstance;

embarrassmentandfeelingofridicule.Atdifferenthospitals,greater importancehas

beenplacedontherecordkeepingaspectthanoncompliance,asaresultofwhichthe

checklisthasbeencompletedhowevercarriedoutinadequately111,112whichhasledto

someexpertsaccentuatingtheneedofcomingupwithstrategiesforthecorrectuseof

thesurgicalchecklist113.

Asregardsanesthesia,theEuropeanCouncilofAnesthesiology,incollaboration

withtheEuropeanSociety forAnesthesiology,promotedtheHelsinkiDeclarationonPatient Safety in Anesthesiology, approved in conjunction with the World Health

Organization, the International Federation of Anesthesiology Societies and the

EuropeanPatients’FederationattheEuroanaesthesiameetingheldinHelsinkiinJune

2010. This declaration includes elementary safety –related recommendations which

werealreadybeingimplementedinpart114,115,116.

� Safecare

Nursing care encompasses a number of procedures and techniques requiring

specialprecautionbeingtaken,duenotonlytotheintrinsicrisk involvedinsomefor

patient safety but also due to the volume and scope thereof at all care-providing

levels.Itisthereforenecessaryforstrategiestobesetoutforpreventingcare-related

adverseeventswithasystemforrankingbyprioritiesaccordingtotheirfrequencyof

occurrence,theseverityoftheirconsequencesandtheirpreventability117.

Historically, nursing has taken care related to the prevention of some adverse

eventsverycloselyintoaccount,suchasfallsorpressureulcers,havingreachedquite

a generalized consensus as to their prevention and the use of and heeding risk

assessmentscales118.

� Patientidentificationsafety

Approximately13%oftheerrorsreportedinthesurgicalfieldand67%ofthose

related to the transfusion of blood components have to do with erroneous patient

identification119.Thatiswhysettingoutmeasureforguaranteeingpatientidentification

safety, their samplesandall of their information, isoneof the top-prioritypractices

recommendedbydifferentinternationalorganizations(Table5).

47

For proper patient identification, it is recommended: to use at least two

identifiers (never bed or room number), to promote automated identification, to

alwayschecktoverifythepatient’sidentitypriortoanyprocedureandtogetpatients

andcaregiversactivelyinvolved120.

� ReportingandLearningSystems

The reportingand learning systemsmake itpossible to report thecare-providing

relatedincidentsandtoobtainusefulinformationofthesequenceofeventshavingled

up to the incident in question having occurred, affording the opportunities to learn

lessonsforpreventingthemfromreoccurring.

The main limitation of the reporting and learning systems is infra-notification,

someofthecausesofwhich includetheorganization’s lackofsafetycultureandthe

professionals’ fearof findingthemselves involved in lawsuitsduetoa lackofspecific

lawtoprotectthem.Thisfearhasabearingonthequalityofthedataobtainedfrom

these systems and on the best use beingmade of the information recorded. These

systemshavebeen found tousuallyachieveagreaterdealofactive involvementon

thepartoftheprofessionalswhentheyarevoluntaryandanonymous.

The reporting and learning systems are explicitly recommended by the World

HealthOrganization121andbytheCounciloftheEuropeanUnion7.TheWorldHealth

Organization is currently carrying out a project in collaboration with the European

CommissionandtheMemberStatesforthepurposeofsettingoutamodelofminimal

information for reporting on patient safetywhichwillmake it possible to set out a

commontaxonomyandcomparisonsamongcountries122.

In the report prepared by the European Commission on implementation of the

recommendations put forth by the Council of the EuropeanUnion, it is pointed out

that the reporting and learning system is a useful learning tool which favors the

dissemination of the patient safety culture, provided that the professionals are

properly informed in a timely fashion concerning the problems identified and the

measurestakenforimprovement67.

Tofavorthedevelopmentofincidentreportingsystems,theEuropeanCommission

has recently published a report on findings and recommendations of the European

Unionpatientsafetyincidentreportingsystems71.

48

� Patientandcaregiverparticipation

Thechangeintheprofileofthepatientsandthedevelopmentoftheirentitlement

toautonomyanddecision-making regarding theownhealthentailsbothachallenge

andanopportunity forthehealthsystem.Theparticipationofthepatientshasbeen

moreappreciable in thecaseofchronicdisordersyethasbeen toa lesserdegree in

aspects concerning patient safety. Nevertheless, some experts point out that the

patientscanplayanoutstandingrole inthepreventionof incidents123,thisbeingthe

reason why different international organizations have developed strategies for

promotingtheirparticipationforthesafety.

Theneedofgettingpatientsactivelyinvolvedandempoweredfortheirsafetyhas

beenpointedoutbydifferentinternationalorganizations:

¡ TheWorldHealthOrganizationhasspearheadedpatientparticipationfortheir

ownsafetywiththeprogram“PatientsforPatientSafety”48,startedin2005..

Thisprogramaimstoincorporatethepatient,familyandcommunityvoiceinto

alllevelsofhealthcarethroughengagementandempowerment

TheWorldHealthOrganizationrecommendstocreatemechanismsforgiving

patients theopportunity to takepart in thehealth carepolicies and in their

health process at three levels:macro (by fostering their participation in the

patient safety policies), meso (by means of participation on professional

committees, taking training, etc.) and micro (being provided with clear

informationandsharingdecisionsregardingtheirhealthprocess).124.

¡ The recommendations of the Council of the European Union concerning

patientsafetyurgedtheMemberStates tocarryoutactions for thepurpose

of:

– Gettingthepatients’organizationsactivelyinvolvedinthedevelopmentof

safety-relatedpoliciesandprogramsatalllevels.

– Informing patients on safety standards and measures implemented for

reducingorpreventingadverseeventsandfacilitatingthedecision-making

process.

– Getting complaint procedures and compensation systems under way, as

wellasthetermsandconditionsfortheirimplementation.

However, the latest EuropeanCommission report on the implementationof the

aforementioned recommendations reveals that no progress has been made in this

49

field, and that the term “empowerment” still as yet remains unclear for many

countries67. Different projects funded by the European Commission are aimed at

promoting the sharing of experiences and improving the knowledge on this subject

(PaSQ65,EMPATHIE125,Value+126).

Table 7 provides a description of other initiatives carried out by different

internationalagenciesforpromotingpatientparticipationandempowermentfortheir

safety.

Table7.Actionscarriedoutbydifferentorganizationtofacilitatepatientparticipationfor

theirsafety

Organization Actions

The Joint Commission http://www.jointcommission. org/

Educational material and specific campaigns such as “Speak Up” for encouraging patients to ask professionals questions and thus help them to take an active role in preventing errors in the health care provided127.

National Patient Safety Foundation

Resources, information and publications. Annual patient safety awareness week128.

U.K. National Health Service

Recommendations drafted based on experiences in citizen participation emphasizing the importance of patients as active stakeholders in the process of further enhancing safety, reiterating the need of heightening the levels of basic health knowledge and patient autonomy for managing their own health129.

Institute for Heath Improvement

Actions for facilitating patient participation, including patients and caregivers in the verification of safe practices (identify the patient before taking medication), re-checking a diagnostic test or intervention at the point in time at which the patient or family member so requests; inviting patients and caregivers to take part in multidisciplinary rounds; facilitating patient/caregiver participation on the safety committees130.

National Patient Safety Foundation’s Lucian Leape Institute

Guide with recommendation and tools for favoring the collaboration between professionals and patients for safety131.

Australian Commission on Safety & Quality in Health Care

Programs for fostering clear, transparent information for patients and caregivers when an adverse event occurs for the purpose of further enhancing the quality and safety of the health care provided132.

The experiences carried out show that when setting out strategies for

promoting the participation of the patients for their safety, the patients’ needs and

expectations, the opinions of the professionals and thematurity of the organization

mustbetakenintoaccount133,134.

50

iii.InterventionscarriedoutintheNationalHealthSystem

To make reference to the current patient safety situation in Spain, mention

must necessarily be made of the actions promoted by theMSSSI which have been

beingcarriedoutasof2005within the frameworkof thepatientsafetystrategy3, in

additiontothosecarriedoutbytheHealthRegions,thehealthcarecenters,academic

institutionsandotherorganizationswhichhaveshownaninterestinthissubject2,135.

ThestrategylinesincludedintheNationalPatientSafetyStrategyforthe2005-

2013 period were in keeping with the top-priority objectives thereof: fostering the

patientsafetycultureamongtheprofessionalsandthepatientsatanylevelatwhich

healthcareisprovided,trainingtheprofessional inpatientsafety, implementingsafe

practices, research into adverse events and their conditioning factors and getting

patientsandcitizensactivelyinvolved.

Deployingtheaforementionedstrategyentailedbothapoliticalandeconomic

commitment with all of the regional services, although this strategy has been

implementedtodifferingdegreesfromoneAutonomousCommunitytoanother,and

the funding allocated has ceased to exist as a result of the current economic

restrictions.

A description is provided in following of the actions carried out within the

frameworkofthePatientSafetyStrategyforthe2005-2013period.

51

PATIENT SAFETY STRATEGY LINES CARRIED OUT IN THE NATIONALHEALTHSYSTEM

� Patientsafetyculture,humanfactorandtraining

ForthepurposeofmeetingthefirstobjectiveofSpain’sNationalHealthSystem

QualityPlanStrategyNumber8(topromoteandfurtherthepatientsafetycultureand

knowledgeamongtheprofessionalsandpatientsatany levelatwhichhealthcare is

provided)theMSSSIhasbeenholdingforums,workshops,meetingsandconferences

at the national and international level, has been disseminating news and

recommendationsbywayof itsWebsiteandhasbeendevelopingtrainingcourses in

patientsafetyforprofessionals.

¡ Information and dissemination. The different Health Regions have echoedthese initiatives and have, in turn, carried out seminars, forums,meetings

and have disseminated aspects for furthering and implementing the safety

culture.

The scientific societies have also been holding forums where the

patient safety-related aspects have played a leading role and have also

promoted the implementation of safe practices among the professionals.

Specialmentionmayalsobemadeinthisregardoftheworkwhichisbeing

done by the scientific societies, coordinated by the MSSSI, for identifying

those aspects of the care providedwhich do not provide any added value

andwhichmayentailariskorharmforthepatient136,137,138.

¡ Perception-relatedstudies.TheMSSSIhaspromotedstudiesforthepurpose

ofgettingtoknowthepatientsafetycultureindifferenthealthcaresettings:

– In the field of hospital care, the Hospital Survey for Patient Safetydeveloped by the Agency for Health care Research and Quality wasadaptedintotheSpanishlanguageandvalidated,havingbeenusedona

randomsampleof24oftheacutehospitalsintheNHS.Themainfindings

of this study showed that the professionals considered safety to be

acceptable and acknowledged weak points with regard to “Staffing”,

“Teamwork among units and departments”, “Perception of safety” and

“Hospital Administration support in patient safety”. This study

additionallystressesthattheworkingpaceatmanyhospitalsmayhavea

bearingonpatientsafety139.

52

– In primary care, the Medical Office Survey on Patient Safety Culture(MOSPS)developedby theAgency forHealth careResearchandQualitywasadaptedandvalidated,thenhavingbeengivennationwideto4,344

professionals from215healthcenters in15HealthRegions.Thenursing

professionals showed higher levels of patient safety culture than the

physicians, thephysicianshavingshown, in turn,ahigher level thanthe

alloftheotherprofessionalcategories.Theadministrativestaffmembers

are,according to thesurvey findings, theprofessional category showing

the leastdegreeofpatient safety culture. Similarly, theprofessionals in

positions of responsibility or leadership positions showed a greater

degree of patient safety culture compared to those not holding

leadership positions, those over 40 years of age compared to those

youngerandtheprofessionalswithsmallerquotas(1,000ormorehealth

systemcards)comparedtothosewhohadagreaternumber. Generally

speaking, the perception of patient safety among the primary care

professionalsispositiveonanoverallbasisaccordingtothisstudy140.

¡ Trainingprofessionals

After the efforts made over these past years in training health care

professionalsinpatientsafety,thefollowingassessmentcanbemadeofthe

currentsituation:

– Itisdifficulttoassesstheimpactofthetraining,notonlyatthe

individuallevelbutalsotheinstitutionalrepercussionthereof.In

any case, according to thedata available from theNHS2, there

are a major number of professionals possessing training in

patient safetywho are playing amajor role as instructors and

promotorsofthechangeintheirworksettings.

– Asnowballeffect isbeingcaused,asaresultofboththeboost

provided by the MSSSI and the recommendations from the

WorldHealthOrganizationandfromtheCounciloftheEuropean

Unionandthe interesttakenonthepartoftheHealthRegions

andsomeuniversitiesand institutionsofaprivatenature,who

have carried out training initiatives in patient safety at certain

times.

53

– Although attempts have been made to incorporate patient

safety as transversal training, the truth of thematter is that it

still has not been formally integrated into either the

undergraduate degree training or the specialized training in

healthsciences.

TheMSSSI patient safety web141 is the showcase for the production of

training resources, reports and experiences of different types which have

beenpromotedandcarriedoutoverthesepastfewyears.Onepointworthy

of specialmention in this regard is the base of projects which have been

beingprogressivelycarriedoutasafinalstudyofthesuccessiveeditionsof

the master’s program and of the risk management course. Those of the

latterareavailablefreelyontheaforementionedweb.

It is necessary for themanagers of each institution to set some overall

patient safety-related objectives and for them to support the initiatives of

theclinicalunitsforthesametobeachieved,byfacilitatingtheknowledge

andtoolsappropriateforcarryingouttheseinitiatives.

Itwouldadditionallybedesirable forpatient safety to comprisepartof

the course curricula of the Schools of Health Science and that all of the

professionalsnewlyincorporatedintotheNHSweretoundergobasicentry

leveltrainingontheconceptsandpracticeofcare-providingsafety.

� Safepractices

¡ Safemedicationuse

In themulticenter studieswhichhavebeencarriedout inSpainasof

2005 for the purpose of making an overall analysis of the frequency and

typesofadverseevents indifferenthealthcaresettings, ithasbeen found

thattheadverseeventsrelatedtotheuseofmedicationscomprisea large

percentageofthetotalnumberofadverseeventswhichoccurintheprocess

ofprovidinghealthcare(Table8).

54

Table8.Frequencyoftheadverseeventsduetomedicationsinthemulticenterstudies

conductsatthenationallevel

Study

TotalAEs

(%patients)

Mostfrequent

AEs

AEsduetomedications

Percentageof

totalnumber

Preventable

(%)

ENEAS15 9.3%

Medication (37.4%). HAIs (25.3%) Procedures (25%).

37.4 34.8

APEAS26 10.11‰

Medication (47.8%) Baseline disorder evolving for the worse (19.9%) Procedures (10.6%).

47.8 59.1

EARCAS27

Qualitative study Care. Medication HAIs

_ _

SYREC28 33.1%

Care (26%) HAIs (24%) Medication (12%)

11.6% 58.9%

EVADUR29 7.2%

Care-providing process (46.2%). Medication (24.1%) Procedures (11.7%).

24.1% _

-ENEAS:NationalStudyofAdverseEventsRelatedtoHospitalization

-APEAS:StudyofAdverseEventsinPrimaryCare

-EARCAS:AdverseEventsinSocialservicesmedicalservicescentersandLivingfacilities

-SYREC:SafetyandRiskintheCriticalPatient

-EVADUR:AdverseEventsinEmergencyCare

-AE:AdverseEvent

-HAIs:Healthcare-associatedInfections

Other studies also conducted in Spain have specifically characterized and

analyzed thepreventableadverseeventsdue tomedications indifferenthealthcare

settings and have estimated the frequency of medication errors in the different

processesofthesystemfortheuseofmedications.Table9detailsthemostrelevant

aspects of the findings of these studies, which show the major degree to which

medicationerrorshaveanimpactonthehealthcareprovided.

55

Table9.Findingsofstudiesconducted inSpainonmedicationerrorsandadverseevents

relatedtomedications

A total of 1.4% - 5.3% of hospitalized patients experienced adverse events due to medication errors during their hospital stay 142,143. The main types of errors which caused these events were failure to have prescribed a necessary medicine, an incorrect dosage or an inappropriate medicine having been prescribed, an insufficient follow-up on the treatment and interactions among medicines.

An average of 17 errors per every 100 hospitalized patients (16% in prescribing, 27% in transcription/validation, 48% in dispensing and 9% in administration) are estimated to occur daily. A total of 85% did not go as far as to reach the patient, and solely 0.35% caused harm. Omission was the most frequent error in all of the processes144.

According to one multicenter observational study, the error rates in the administration and preparation of medications fall within the 18.2% - 33.4% range (not including errors due to delayed administration), 145.

More than 50% of polymedicated elderly patients may experience reconciliation errors at hospital admission or discharge. The most frequent types of errors are the omission of medicines and the difference in the dosage timing 146.

Medication errors were the cause of 4.7% -5.0% of the hospital admissions to medical units. The main types of errors identified were an inappropriate medicine or too high a dosage having been prescribed, inappropriate follow-up, failure to adhere to the treatment or inappropriate self-medication147, 148.

In 2011, the estimated cost for the NHS of the preventable medication-related adverse events in hospitalized patients, plus those having caused hospital admissions and calls to emergency services totaled approximately 1.779 million euros (which would amount to 2.9% of all NHS health care spending)39.

In2007, theMSSSIpublished the “Self-AssessmentQuestionnaireon

the Safety of the System for the Use of Medications at Hospitals”149, an

adaptationoftheMedicationSafetySelf-AssessmentforHospitals150,making

it possible to fully evaluate indetail the implementationof safemedication

practices. Based on the aforesaid publication, a nationwide study was

conductedthatsameyearforthepurposeofknowingthebaselinesituation

of Spain’s hospitals with regard to the implementation of safe medication

practices151.Thissamestudywasrepeatedin2011forevaluatingthechanges

which had taken placewithin that time frame152. The information obtained

afforded the possibility of ascertaining that progress had beenmade in the

process of implementing safe practices in the systems for the use of

medications,howeverthat,despitetheprogressmade,therewasstillagreat

dealofroomleftforimprovement.

56

Table 10 shows the findings for 2007 and 2011 for the evaluation

itemsincludedonthequestionnairewhicharebest inkeepingwiththetop-

prioritysafepracticesrecommendedbydifferentinternationalorganizations.

The findings are stated in the form of percentages of themaximum figure

possible for each item to be assessed, which reflects their degree of

implementation at the participating hospitals. It was objectively found that

some practices had been implemented to quite a great degree in the NHS

(avoiding verbal prescriptions and dispensing the medicines in individual

doses),andothershadundergonenoticeableincreasesoverthecourseofthe

time frame in question (the incorporationof the e-prescriptionwith clinical

decision-makingsupport,thesettingupofsystemsforreportingandlearning

from medication errors). In other cases, changes of a lesser degree were

observed (avoiding theuseof free-flowpumpsandpreventingerrors in the

connectionofcatheters)orthatthepracticeshadbeenimplementedtoonly

averysmalldegree(validationofalloftheprescriptionsbyapharmacistand

theintegrationthereofintotheclinicalteams).

57

Table 10. Top-priority safe practices related tomedications suggested by different organizations and degree towhich implemented inSpainaccordingtothestudiesconductedin2007(n=105hospitals)and2011(n=165hospitals)withthe“Self-AssessmentQuestionnaireonSafetyintheSystemforUseofMedicationsinHospitals”.

Top-prioritysafepractices Suggestedby

Mainassociatedassessmentitems

Findings(%ofthemaximumfigurepossible)*2007Study(n=105)

2011Study(n=165)

Implementinge-prescriptionprogramswithclinicaldecision-makinghelpsystems AHRQ,NQF 52,53 32%,26% 60%,46%

Avoidingverbalprescriptionsandsettingupaverificationprocedureforuseineventofemergencies NQF,JC 58,59 68%,85% 70%,91%

Settingoutalistofabbreviationsandacronymswhichmustnotbeused

AHRQ,NQF,JC 57 17% 30%

Integrationsoftheclinicalpharmacist-Validationofalltheprescriptions-Incorporationintothecare-providingteams

AHRQ,NQFJC

3638,39

44%34%,23%

47%35%,27%

Practicesforfurtherenhancingthesafetyofhigh-riskmedicines-Identification,maximumdosages,double-checking-Standardizingandlimitingtheconcentrationsofmedications-Removingconcentratedelectrolytesolutions-Settingprotocolsforanticoagulants

NQF,JCOMS

30,32,123y22386.1,86.2

110-

42%,33%,13%y7%44%,50%

14%-

52%,43%,26%y19%50%,51%

33%-

Practices for preventing errors due to similar names ofmedicines OMS 68,69,70 37%,53%,26% 46%,63%,32%

Dispensingthemedicationsindividualdoses NQF 76 77% 83%Labellingallofthemedicationsandcontainers/devicescontainingthem NQF,JC 84,85 52%,53% 58%,59%

Avoidingtheuseoffree-flowpumps JC 130 46% 64%

58

Incorporatingnewtechnologiesinadministration–Barcode-Smartinfusionpumps

NQF 16128

8%41%

14%42%

Preventingtheerrorsinconnectingcathetersanddevices OMS 122,124 32%,35% 44%,50%

Medicinereconciliation-Obtainingafulldrugtherapyrecordonthepatient

AHRQ,OMS,NQF,JC

21 49% 56%22 28% 38%

-Reconcilingthemedicationatadmissionanddischarge 23 45% 51%-Reconcilingthemedicationontransfersfromoneunittoanother

173 35% 45%

-Providingwritteninformationonthemedicationatdischarge

Educatingthepatientsregardingthemedicationandfosteringtheiractiveinvolvement

NQF,JC Criterion16 44% 52%

Maintainingmedicationreportingandmanagementprograms NQF Criterion18 22% 41%

*Findingsgivenintheformofapercentageofthemaximumvaluetheitemevaluatedwouldhaveiffullyimplemented-AHRQ:AgencyforHealthcareResearchandQuality-JC:JointCommission-NQF:NationalQualityForum-WHO:WorldHealthOrganization

59

¡ Healthcare-associatedinfections

Thestrategies for thepreventionandcontrolofhealthcare-associated infections

require agile, robust, sustainable systems of multi-faceted, standardized measures

promotingtheimplementationofsafepracticesbymultidisciplinaryteams.

Surveillancesystem

Epidemiological surveillance, understood as a continued, systematic process of

collection,analysis,interpretationanddisseminationofdataoninfectiousdiseasesfor

takingtheappropriateactions153

isthebasisoftheinfectioncontrolprograms.These

systemshaveevolvedfromglobalnosocomialinfectionsurveillanceintoasurveillance

focusing on processes related to the prevention and indicators of health care-

associateddiseases.Thecomparisonof these indicatorshasbeen foundtobeuseful

for setting out measures for the preventing and curtailing health care-associated

infections.

In Spain, the Health Regions are currently using different health care-associated

infection surveillance systems. The most widely-used are the Study of Nosocomial

Infections in Spain (EPINE)154

and the National Study of Surveillance of Nosocomial

InfectioninIntensiveCareMedicineServices(ENVIN-HELICS)155

.

– EPINE is a prevalence register making it possible to study the health care-

associated infections in all of the services throughout the hospital, including the

pediatric population. EPINEwas promoted by the Spanish Society for Preventive

Medicine,PublicHealthandHygiene in1990. In2012,EPINEwasadapted to the

European protocol by contributing data to the “Prevalence Point Surveillance

(PPS)”. In 2004, a total of 269 hospitals were participating, with some 55,700

patientshavingbeenstudied.Theprevalenceof infectionwas7.85%,thesebeing

percentagesprogressively on thedecline since2009 (8.59%).Adeclinehasbeen

foundtoexistinthepercentageofinfectionacquiredathospitaladmissionperse

andofthepatientswhowereadmittedwhoalreadyhadaaninfectionbeforehand,

the most outstanding of which was surgical infection. Respiratory infection has

become more prevalent in 2014 (21.4%, followed by surgical infection (20.9%),

urinary infection (20.1%) and catheter-associated bacteremia (15.3%). The data

also shows a discreet decline in the number of patients undergoing antibiotic

treatmentatthepointintimeofthestudy(45.4%)154

.

60

– ENVIN-HELICSisanincidenceregisterdevelopedin1994bytheSpanishSocietyfor

Intensive Care Medicine, Critical Care and Coronary Care Units (SEMICYUC),

affording the possibility of studying the device-related infections acquired on

intensivecareunits.ThisregisterhasbeencompatiblewithEuropeansurveillance

since 2007156

, although the data published in Spain includes the patients

hospitalizedfor longerthan24hours inApril-June,whilstattheEuropeanCenter

forDiseasePreventionandControl;allofthedatafortheyearisrecorded,butfor

staysoflongerthan48hours148

.

The control of the main infections in critical patients includes ventilator-

associated pneumonia, catheter-related urinary tract infection, primary

bacteremia, encompassing the bacteremia of unknown origins plus catheter-

associatedbacteremiaand,lastly,thebacteremia’ssecondarytootherfocalpoints.

The percentage of patients with infections (device-related infections) dropped

from15.5%in2009to5.7%in2014.Thissignificantdropcoincidesintimewiththe

period when the Zero Bacteremia and Zero Pneumonia programs were

implemented157

. Similarly, the use of antibiotics has decreased on the intensive

careunits from122.1to113.8daysofantibioticper100stays.Carbapenemsare

oneoftheantibioticgroupsmostused.

– The National Health System Health Care-Associated Infection Surveillance

System.TheMSSSI,incollaborationwiththeCarlosIIIHealthInstitute,theHealth

Regions and the scientific societies involved, has prepared a proposal regarding

which a consensus was reached with Spain’s Surveillance Body and which was

approved by the Public Health Commission for a national health care-associated

infections surveillance systemswhichwillmake itpossible toavail of systematic,

homogeneous informationwith a standardizedmethodology for ascertaining the

incidence and characteristics of the health care-associated infections and

facilitatingtheirpreventionandcontrol.

ThisproposalisinresponsetoarequestfromSpain’sCongressofDeputiesfora

National Plan for the Control of Health Care-Associated Infections a158

to be

developedandtherecommendationsfromtheCounciloftheEuropeanUnion7for

bolsteringthesurveillancesystemsactiveat thenational level for thepurposeof

evaluating and focusing the infection prevention and control policies on the

medical services centers. Similarly, there was a widespread feeling among the

61

different health authorities in favor of having a health care-associated infection

surveillancesystemforthehealthcareprovidedbySpain’sNHS.

– Surgicalsiteinfectionsurveillance.Thestudyofsurgicalsiteinfectionincidenceis

representative to a much lesser degree than the two aforementioned registers.

Approximately some 30 hospitals from various Health Regions take part in the

surveillance of the surgical processes suggested by the European Center for

DiseasePreventionandControl. SomeHealthRegions suchasMadrid,Catalunya

and the Basque Country has their own individual surgical infection surveillance

program(VIRAS159

,VINCAT160

andINOZ161

,respectively).

– Outbreaks.Althoughthepresenceofoutbreaksofnosocomialinfectionsshouldbe

notifiedtotheCarlosIIIHealthInstitute,complianceisrenderedtoasmalldegree,

the informationthereforebeingobtainedmainlybywayofscientificpublications

orpresentations.

– Antimicrobial resistance. Spain’sMicrobiology laboratories contribute toplotting

themapofresistancesbywayoftheirdatafrombloodculturesandothersafety

samples.Through theCarlos III Institute, the information is sent to theEuropeanAntimicrobial resistance interactive database (EARS-Net) program, currently

centralized at the European Center for Disease Prevention and Control 162. ThefindingsrankSpainamongthosecountrieshavingthehighestlevelofantimicrobial

resistances,especiallyforgram-negativebacteria,althoughtoalesserdegreethan

Greece,ItalyandPortugal163

.Thelatestdataisfor2011,thefiguresprovidedbeing

lowerthanthefiguresshownintheEPINEregisterfor2014154

.

– Antimicrobialconsumption.Spainprovidestheconsumptionsofantibioticsatthe

extrahospital level,not thedata for theconsumptionat thehospital level, to the

program European Surveillance of Antimicrobial Consumption Network (ESAC-Net164), also coordinated by the European Center for Disease Prevention andControl,whichhasbeenmonitoring theuseofantibiotics foryears.Thenational

dataonuse inhospitalizedpatients isobtainedfromEPINEandENVIN-HELICS. In

general, the data suggests a high degree of use and a high percentage of

treatments in health care-associated infections without any supporting

microbiologicaldocumentationservingasabasis.

Programs for preventing health care-associated infections promoted by the MSSSI,

withintheframeworkofthestrategyforpatientsafety.Someofthemostnoteworthy

oftheseprogramsare:

62

– SpanishNationalHealthSystemHandHygieneProgram.

In2006,Spain joined theWorldHealthOrganization“CleanCare isSafeCare”

campaign,themainobjectiveofwhichistofurtherenhanceadherencetoHand

Hygiene.TheSpanishNHSHandHygieneprogram165,promotedbytheMSSSI,is

beingcarriedoutincollaborationwithalloftheHealthRegionsforthepurpose

offurtherenhancingadherencetoHandHygieneandiscurrentlyimplemented

inmore than80%of thepublichospitalsandmedical servicescenters.Within

theframeworkofthisprogram,aconsensushasbeenreachedconcerningbasic

actions(mainlypromotingtheWorldHealthOrganization’smultimodalstrategy

and trainingof the“5moments”of theprocess)andevaluation indicators for

structure,processandoutcomewhichareevaluatedannually.

Asof2009,WorldHandHygieneDayhasbeenbeingcelebratednationwide

in Spain, with specific actions for professionals and patients in the Health

Regions and medical services centers, following the recommendations of the

WorldHealthOrganizationforthatday.

– Patientsafetyprogramforcriticalcarepatient

TheZeroBacteremiaandZeroPneumoniaprojects157

havemadeitpossible,by

wayofamultifactorialinterventionbasedonthesimultaneousimplementation

of a packageof simple, sustainablemeasures, not only to significantly reduce

theincidenceoftwoofthehighest-impact,highest-costhealthcare-associated

infections,butalsotofavorthenetworkingofmanyprofessionalsandcenters

nationwide and to serve as a reference study ofwhat should be a process of

puttingsafepracticesintopracticeatalllevelsofhealthcare.

– TheZeroBacteremiaProjectobjectiveswere:

a) To reduce the incidence-density rates (IDR) of the catheter-related

bacteremiato<4episodesper1000daysofcentralvenouscatheter.

b) To document all of the episodes of bacteremia, including the

bacteremia’ssecondarytootherfocalpoints,aswellastheetiologyandthe

characteristicsofthepatientswhoexperiencetheseepisodes.

c) To create working groups with leadership abilities which can follow

programsforthepreventionofothernosocomialinfections.

d) Tobolsterthesafetycultureinthemanagementofcriticalpatients.

63

Overthecourseofthe18monthsofthestudy(2009-2010),192ICUsfrom

all of theHealth Regions contributed cases, a 50%drop in the rate having

beenachievedinalltypesofhospitals166

.Itwasestimatedtowardtheendof

2013that384deathshadbeenpreventedand159,630.700€hadbeensaved

onhospitalstays.

– ZeroPneumoniaProject.FollowingthesamesetupasforZeroBacteremia,a

specificpackageofmeasuresandanintegralsafetyprogramwereproposed

in agreement with the Health Regions, the Spanish Society for l Intensive

CareMedicine, Critical Care and Coronary Care Units (SEMICYUC) and the

SpanishSocietyforIntensiveCareNursingandCoronaryCareUnits(SEEIUC).

The main objective was to reduce the IDR of Ventilator-Associated

Pneumonia (VAP) to < 9 episodes x 1000 days of mechanical ventilation

maintainingthesecondaryobjectivesof theZeroBacteremiaProject.More

than 240 ICU’s (80% of all ICUs in Spain) have taken part in the project,

havingachievedarateof lessthan7episodesper1000daysofmechanical

ventilation.Ithasbeenestimatedthat340deathshavebeenpreventedand

164millioneurossaved167

.

– Programs for the Optimization of In-Hospital Use of Antibiotics (PROA): The

Spanish Society for Infectious Diseases and Clinical Microbiology, the Spanish

SocietyofHospital Pharmacyand theSpanishSociety forPreventiveMedicine,

PublicHealthandHygienehavecometoanconsensusandpreparedaprogram

forfurtherenhancingtheprescriptionofantimicrobialdrugsforthepurposeof

reducingtheresistances,whichhasbeenbeingcarriedoutsuccessfullyinseveral

oftheSpanishNHShospitals168.

– Strategicplan foraction for reducing the riskof selectionanddisseminationof

resistances to antibiotics. Coordinated by the MSSSI through the Spanish

MedicinesandMedicalProductsAgency(AEMPS), thisPlancoversbothhuman

and veterinary medicine, having as its objective that of reducing the risk of

selectionanddisseminationofresistancestoantibiotics,alsoaimingatrendering

compliancewiththeEuropeanCommissionCommuniquéofNovember17,2011,

bywayofwhichthememberStateshavebeenrequestedtosetoutaplanfor

actionregardingresistancestoantibiotics,aswellastheConclusionsofCouncil

oftheEuropeanUnionofJune22nd,urgingthatajointapproachbetakentothis

issue169

.

64

TheagenciesandinstitutionswhicharecollaboratinginthisPlaninclude:

TheSpanishMinistryofHealth,SocialServicesandEquality (SpanishMedicines

andMedicalProductsAgency,theSpanishFoodSafetyandNutritionAgencyand

different General Directorates), the Ministry of Agriculture, Food and

Environmental Affairs, Ministry of Economy and Competitiveness (Carlos III

Health Institute), Complutense University of Madrid, Spanish Antibiogram

Committee,ScientificSocietiesinvolvedandOfficialProfessionalOrganizations.

� Surgery

InSpain,theincidenceofadverseeventsduetosurgeryisaround10.5%(8.1%-

12.5%),atotalof36.5%ofwhichwouldbepreventable170

.

In the National Patient Safety Strategy for the 2005-2011 period, it was

recommendedthatactionsbeimplementedforpromotingSafeSurgeryasofJanuary

2008, coinciding with the launching of the World Health Organization’s second

challenge “Safe Surgery Saves Lives”. The basic principles of this challenge were

classifiedinto4areas(1.Thepreventionofsurgicalwoundinfections2.Thesafetyof

anesthesia3.The trainingof safesurgical teams.4Themeasurementof thesurgical

services) aimed at achieving some top-priority objectives for preventing the adverse

events in surgery for which the World Health Organization facilitates as tools the

surgerysafetychecklistandamanualfortheimplementationthereof45.

TheHealthRegionsrecommendedandcontributedinitiativesandstandardsfor

the implementation of the aforementioned list in their hospital networks. Most of

these practiceswere included as recommendations in the document “Surgical Block

Standards and Recommendations”171

published by the MSSSI, which additionally

included theadaptationof the liston thepartof theSpanishSurgeon’sAssociation.

Despitetheseactions,theprocessofimplementingthesafesurgerychecklistinSpain’s

NHShasbeendifficult,incompleteandhighlyvarying.

The World Health Organization’s challenge also proposed a minimum set of

uniform indicators (“vital surgical statistics”) for the national and international

surveillanceofsurgicalcare.Theinformationon“vitalstatistics”isvariableatthelevel

oftheHealthRegions,noregisterexistingforthesestatisticsatthenationallevel.

Someoftheotheroutstandingeffortsincludetherecommendationsonthepart

oftheSpanishSocietyforAnesthesiologyandResuscitationfortheAnesthesiaservices

to adopt the principles of the Helsinki Declaration on Patient Safety in

Anesthesiology116

, which the Spanish Society for Anesthesiology and Resuscitation

65

subscribed in its launching in June 2010. Also worthy of special mention is the

publication of recommendations for the labeling of drugs administered in

anesthesiology and the publication of a pre-procedure anesthesia equipment

checklist172

.

� Safecare

The ENEAS report attributes 7.63% of the adverse events to care-related

causes15. The factors associated with these adverse events comprise useful

informationfortargetingthestrategiesaimedatfurtherenhancingpatientcare.

As a result of the decentralized funding of the Health Regions within the

frameworkofthePatientSafetyStrategywithinthe2005-2011timeframe,ithasbeen

encouragedthatdifferentprojectsandbestpracticesbegottenunderwayinnursing

care which have made it possible to further enhance the aspects related to the

prevention and treatment of pressure ulcers, fail-safe patient identification, the

furtherenhancementofthepreventionofaccidentalfalls,thepreventionofinfection

withtheHandHygienestrategies,thereductionofcatheter-associatedbacteremiaor

ventilator-associatedpneumonia,andthesafeuseofmedications.

Nevertheless, the safe carepracticeshavenotbeen implemented in full, and

thedegreetowhichimplementedhasvariedgreatlynationwide.Someofthepossible

causes may include the nursing care plans barely existing at all and the scarcity of

specificinformationsystemsmakingitpossibletoevaluatethesame.

The reference study on patient safety in regard to the care provided is the

project“StandardsofCareQualityforPatientSafetyinSpain’sNHShospitals,knownas

the “SENECA” study173

, fundedby theMSSSI, basedonwhich different standards of

carequalityforSpain’sNHSwerevoluntarilyevaluated.Thisstudymadeitpossibleto

ascertainthequalityofthecareprovidedrelatedtopatientsafetynationwideandto

recommendanumberofmoreorlesscomplexpracticeswhichwerethenfollowedto

differingdegreesbytheHealthRegions.

Measures aimed at setting out a crisis plan for the propermanagement of severeadverseevents

According to the Gallagher study, a total of 55% of all Canadian and U.S.

physicians acknowledged having made a clinical error174

. In Spain, according to the

ENEASstudydata, itcanbeestimatedthataround15%of thehospitalprofessionals

66

may find themselves involved in an adverse event per year15, although they be a

matterofadverseeventswithoutanysevereconsequencesinmostcases.

When a severe adverse event occurs, the patient is themain victim, but the

professionalsinvolvedarethesecondvictims.Therepercussionsofadverseeventson

the second victimsmay go so far as to leave them incapacitated, seriously affecting

theircarryingouttheirduties,aboveallwhenthere isexternalsocialpressure175

. In

Spain,thereareveryfewstudiesdealingwiththeconsequencesofadverseeventon

professionals176

,itthereforebeingnecessarytolearnfromtheexperiencescarriedout

inothersettings177

. Itwouldbedesirable for themedical servicescenters toavailof

specificstrategieswhichweretoinclude:whatmustonedoandnotdowhenasevere

adverse event occurs; actions for frankly communicating with the patients and

caregivers;proceduresforsupportingtheprofessionalsinvolvedintheadverseevents;

andtheapproachastohowtomanagethecommunicationwiththemediaoncethey

have occurred. The experiences carried out in other countries may be useful for

putting into practice in these situations178, 179,180,181

. Some Health Regions have

developed guidelines for the management of severe adverse events, including the

approachfordealingwiththesecondvictimsinasystematicmanner182

.

Reportringandlearningsystems

TheMSSSIhaspromotedtheReportingandLearningSystemforPatientSafety

(SINASP)183

as a reporting system readily available to the health care professionals

throughtheirregionalhealthservices.AtotalofnineHealthRegionsandtheNational

HealthcareManagement InstituteforCeutaandMelilla (INGESA)arecurrentlyusing

thisreportingsystem,whilstalloftheotherHealthRegionshavedevelopedtheirown

reportingsystems,somepriortotheReportingandLearningSystemforPatientSafety.

Fig.2detailstheincidentreportingsystemsdevelopedinSpain’sNHS, inconjunction

with their characteristics (anonymous, voluntary, type of incident, setting and

accessibilitytopatients).

67

Fig.2.IncidentreportingsystemsdevelopedinSpain’sNHSandtheircharacteristics

CISEM-AP: Notification of safety-related incidents involving no harm ormedication errors in primary

care;FHC:Adverseeffectingreportingandregistrysystems;SGIS:Safety-relatedincidentmanagement

system;SINASP:ReportingandLearningSystem forPatientSafety; SINEA: Incidentandadverseevent

reporting system SISNOT: System for reporting incidents not involving any harm; SNASP: System for

reporting and learning in patient safety; TPSC: Platform for the management of patient safety; AE:

Adverseevent;PC:Primarycare

ThegreatestconcernexpressedbySpanishprofessionalshavingtodowiththe

reporting systems is with regard to the lack of legal protection when the adverse

eventsarereported.ThelegalopinionreportscommissionedbytheMSSSIsuggestthe

need of introducing legislative changes for guaranteeing the protection of the

professionalsinvolvedinreportingoranalyzingadverseevents184

.

� Patientandcaregiverparticipation

Theactive involvementandempowermentofpatientsandcaregivers in their

own clinical safety have been taking on growing importance at the national and

internationallevel.Inthisregard,theMSSSIorganizedaworkshopforascertainingthe

Reportingsystem

Characteristics

Anon.

Voluntary

AE

PC

Patients

Ceuta Melilla

CanaryIslands

1hospital

68

opinions, expectations and positioning of experts, representatives of patients’

associations, consumers, users and patient advocates in different Health Regions

concerning this matter and their possible participation in future actions aimed at

preventingrisksandproposingpatientsafety-relatedsolutions.Thisdocumentandthe

CitizenTrainersNetworkdevelopedfollowingtheworkshopmarkedamilestoneinthe

change necessary for getting patients and caregivers actively involved in further

enhancingclinicalsafety.Currently,theCitizenTrainersNetworkhasbeenintegrated

intoSpain’sNHSCitizenHealthSchoolsNetworkpromotedbytheMSSSIandcarried

outincollaborationwiththeHealthRegions186

.

Researchintopatientsafety

Safehealthcarerequiresemployingproceduresandpracticeswhichhavebeen

shown to be effective for reducing the occurrence of mistakes, errors and adverse

outcomesandalsoforgeneratingnewknowledgeastothefactorswhichcontributeto

furtherenhancingpatientsafety.

Patient safety andpatient safety-related incidents the twoopposites sidesof

onesamecoinasyettobeminted:themanagementoftheriskinvolvedinproviding

healthcare.

Thefollowingcanbeconsideredasareasforresearchinpatientsafety187

:

– Quantifyingthemagnitudeandcharacteristicsoftheclinicalrisk

– Improving the comprehension of the factors which contribute to the

occurrenceoftheincidentsrelatedtopatientsafety.

– Evaluatingtheimpactoftheadverseeventsonthehealthsystem.

– Identifying effective, feasible and sustainable solutions for achieving safe

healthcareandpreventingadverseeventsandincidents.

Specialmentionmustbemadeof the fact that a greatnumberof articles and

monographicstudiesonpatientsafetyhavebeenpublishedinSpanishjournalsinthe

fieldofclinicalquality188

.Aneithersystematicnorcompletelythoroughreviewofwhat

hasbeenpublishedoverthepastfewyearsleadsonetotheconclusionthattherehas

beenamajor increase in the amountof researchonpatient safetypublishedat the

national and international level in comparison to earlier time frames189,190

. Despite

thisincrease,itstillcontinuestobenecessarytogeneratevalid,accurateevidenceon

the impactof clinical andorganizational solutionswhichwill furtherenhance safety.

69

Similarly, delving deeper into the epidemiological study of incidents and adverse

eventswillmake it possible to better know the risk factors of the patientswho are

mostexposedtoexperiencingadverseeventsandwillfacilitatetheimplementationof

preventionstrategies.

DEPLOYING THE PATIENT SAFETY STRATEGY IN THE SPANISH NATIONAL HEALTHSYSTEM

For the purpose of availing of updated information on the deployment of

strategies, programs and actions which are being carried out in Spain’s NHS with

regardtopatientsafety,sharinginformationandfosteringthesharingofexperiences,

a questionnaire was sent out to the Health Regions’ in which information was

requestedconcerningorganizationofthepatientsafetystrategy,developmentoflines

ofactionfundedbytheMSSSIupto2012,reportingsystem,patientparticipationand

deploymentinprimarycare.

TheseventeenHealthRegionsandINGESAansweredthesurvey.

The findings are detailed in following, summarized by each dimension of the

questionnaire:

� DevelopmentofthepatientsafetystrategyonthepartoftheHealthRegionswith

regardtoitsorganization:

o A total of 13 Health Regions say they have a Patient Safety Strategy

(72.2%).Therestsaytheyaregoingtodevelopastrategy.

� ActionscarriedoutbytheHealthRegionsforfosteringthesafetyculture:

o Allof theHealthRegionsarecarryingoutpatientsafetytrainingactions,

81%sayingtheycurrentlyhaveaspecificpatientsafetytrainingprogram

inplaceforhealthcareprofessionals.

o Atotalof72.2%oftheHealthRegionssaytheyarefurnishinginformation

to professionals concerning standards, measures for reducing incidents

andbestpracticesinpatientsafety.Therestsaytheyareworkingonthis

aspect.

� Safe practices implemented, recommended in the strategy for patient safety

carriedoutintheNHS.

o Fig. 3 details the information furnishedby theHealth Regions concerning

theimplementationoftheseactivitiesinspecializedcareandinandinFig.4

70

for primary care. These actions are being carried out at all or several

centersoftheHealthRegions.

Fig.3.Safepracticesrecommendedinthepatientsafetystrategywhichareimplemented

inspecializedcareintheNHS(includingthe17HealthRegionsandINGESA)

ACs:HealthRegions

No.AC’s(AutonomousCommunities)

Antimicrobialresistances

Safeuseofhigh-riskm

edications

Medicationreconciliation

Pressureulcers

Preventionoffalls

ZeroBacteriemia

ZeroPneumonia

HandHygiene

SafeSurgery

Patientidentification

71

Fig.4.SafepracticesrecommendedinthepatientsafetystrategyimplementedinSpain’sNHS

primarycare(includingthe17HealthRegionsandINGESA)

ACs:HealthRegions

A remarkable difference among Health Regions is noted in the

implementationof theeighteffectivepractices targetingprimarycare, solely

two Health Regions incorporating all eight of these practices, three

incorporating six of the practices and in the lower range, one Autonomous

Communitywithonesinglepracticeimplemented.

In addition to these practices, theHealth Regions implement other safe

practicesinkeepingwiththeobjectivesoftheirstrategies.

Asfarastheimplementationofsafepracticesisconcerned,itmayalsobe

saidthat,withintheframeworkoftheJointActionforPatientSafetyandCare

Quality (PaSQ), twelve Health Regions and 121medical services centers are

taking part in the implementation of the four safe practices recommended:

Multimodal strategy for further enhancing Hand Hygiene, surgical checklist,

medication reconciliation and scale for the early detection of clinical

deterioration in pediatrics191

. The evaluation is made by means of a

questionnaireandspecificindicators.

No.AC’s(AutonomousCommunities)Antimicrobial

resistances

Useofhigh-risk

medications

Medication

reconciliation

Pressureulcers

Preventionoffalls

HandHygiene

SafeSurgery

Patientidentification

72

� AlloftheHealthRegionshavesomesystemforreportingincidentsrelatedtothe

healthcareprovided.Dueto their frequency, theReportingandLearningSystem

forPatientSafetyisthefirst-linesystem.Theimplementationismostlyinhospitals

andprimarycare,althoughthishasalsobeenextended,insomeHealthRegions,to

social services medical services centers, extrahospital emergency services,

psychiatriccenters,etc.

� A total of 50% of the Health Regions stated having informed the Patients’

Associations in theCommunityof thestrategiesorprogramsbeingcarriedout in

patientsafety,atotalof39%nothavingdonesoand12%nothavingansweredthis

question.

o A total of 14 Health Regions answered that there is no stable setup for

patientand/or caregiverparticipation inpatient safety; a totalof3having

answeredthatsuchasetupdoesexistandonenothavingansweredatall.

o Most of the actions carried out have to do with activities involving

informationandtrainingforpatients.

� Deployment of the patient safety strategywithin the primary care setting in the

HealthRegions.

o ThreeHealthRegionssaytheyhaveaspecificpatientsafetystrategyinplace

forprimarycare.

o Atotalof sevenHealthRegionsstate theirorganizational chart includinga

person in charge of patient safety in primary care. In the rest, this is

integratedintotheoverallPatientSafetyStrategy.

� Programs/actions carried out by the Health Regions for promoting research into

patientsafety.

o AtotalofsixHealthRegionsfundspecificlinesofresearchinpatientsafety.

Therestcarryoutresearchprojects inpatientsafetywithintheframework

of general lines of research. Similarly, many of them carry out research

projectswithintheframeworkofcarequalityenhancementprojects.

73

Evaluationofthedeploymentofthepatientsafetystrategy

The Patient Safety Strategy has promoted the creation of elements of safety

infrastructure and the implementation of safe practices at the level of the Health

Regions. During the time frame throughoutwhich the strategy is being carried out,

these elements have been being evaluated byway of a number of indicatorswhich

wereagreedwith the InstitutionalCommittee for theStrategy (representatives from

thedifferentHealthRegions).

Theindicatorsproposedhavebeengroupedinto:patientsafetyindicatorsand

theHandHygieneprogramindicators

� Thepatientsafetyindicatorsmakereferencetothelineswhichhavebeenbeing

promoted in the Health Regions andwhichwere funded up to 2011 byway of

specificagreementsorspecifically-allocatedfundingfortheNHSstrategies(Table

11).

Table11.Patientsafetystrategyindicatorsforthe2010-2013timeframe

Spain’sNHSPatientSafetyIndicators

1. %HospitalshavingaPS-relatedIncidentReportingandLearningSystem

2. %PrimarycarecentershavingaPS-relatedIncidentReportingandLearningSystem

3. %HospitalshavingFunctionalRiskManagementUnitswhichareoperative

4. %PrimarycaremanagementdepartmentshavingFunctionalRiskManagementUnits

5. %HospitalshavingaPatientIdentificationProtocol

6. %Hospitalshavingthesafesurgerychecklistimplemented

7. % Patients having undergone electric surgery regarding whom the safe surgery

checklistisimplemented

8. %Hospitalshavinghigh-riskmedicationprotocolsinplace

9. %Hospitalshavingprotocolsinplaceformedicationreconciliationatdischarge

10. %Hospitals using the self-check safety questionnaire regarding the system for in-

hospitalmedicationuse

74

Fig.5.Resultsoftheevaluationofthepatientsafetyindicatorsforthe2010-2013timeframe

IncidentRS: Incident reporting systems for learning; FRMUs: functional riskmanagement units; SUM:

safeuseofmedication;HRM:high-riskmedication;SSC:safesurgerychecklist

Theresults forthese indicators(Fig.5)showthatalthoughthemajorityofsafe

practices evaluated having been being carried out properly at the hospital, this not

havingbeenthecaseinprimarycare.

�HandHygiene indicators. Spain’sNHSHandHygieneprogramhasbeenbeing

carried out since 2008 in collaboration with the Health Regions with whom a

consensushasbeenreachedregardingdifferentindicators(Table12).

%Hospitals

w/IncidentRSs

%PCmanagement

dept.w/IncidentRSs

%Hospitalsw/

operativeFRMUs

%PCManagement

deptssw/operative

FRMUs

%Hospitalsw/Identification

Protocol%Hospitalw/SSCinplace

%Patientsunderoingelective

surgeryforwhomtheSSCis

employed

%Hospitalsw/HRMprotocols

%Hospitalsw/Medication

ReconciliationProtocol

%HospitalsemployingSUM

self-checkquestionnaire

100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

0%

2010

2011

2012

2013

75

Table12.Spain’sNHSHandHygieneprogramindicators

Spain’sNHSHandHygieneprogramindicators

1. %Bedswithalcohol-basedproductintheroom

2. %Bedsonintensivecareunitswithalcohol-basedproductatcare-providingpoint

3. %Primarycarecenterswithpocketalcohol-basedproductforhomecare

4. %Hospitalshavingtrainingactivitiesinplace

5. %Primarycarecentershavingtrainingactivitiesinplace

6. Consumptionofalcohol-basedproducthospitalization:litersofalcohol-basedproduce

foreverythousandpatientsperday

7. %Bedswithalcohol-basedproductatcare-providingpoint

8. %Hospitalswhichobservecompliancewiththe“5moments”

9. %Hospitalsconductingself-checkaspertheWHOrecommendations

10. %Hospitalshavingtrainingactivitiesinthe“5moments”

Theresultofthemeasurementoftheseindicatorsshowsanimprovementover

thecourseoftimeforallofthemexceptfortheaspecthavingtodowithtraining in

HandHygieneinprimarycare.

76

Fig.6.ResultsoftheevaluationoftheNHSHandHygieneindicators

ABP:alcohol-basedproduct;ICU:intensivecareunit;PCC:primarycarecenter

The consumption of alcohol-based products has been progressively improving

overthepastfewyearsuptothepointofmeetingthestandardsrecommendedbythe

WorldHealthOrganization(Fig.7).

Fig.7. Evolutionof the consumptionofalcohol-basedproduct in theNHS for the2009-2013

period

RoomswithABP

ICUswithABPs

PCCwithABPs

HospitalTraining

Trainingin“5

moments”Hospitals

PCCTraining

ABPcare-providing

point

Compliancew“5

moments”Hospitals

Self-checkHospitals

77

� Indicatorsofspecificprograms

Evaluationshaveadditionallybeenbeingmadeofindicatorsofspecificprograms

suchasSINASP,ZeroToleranceontheintensivecareunits,safeuseofmedication,the

resultsofwhicharedisseminatedbywayoftheMSSSIPatientSafetyWeb192.

� Accreditation

Theperiodicevaluation,whichismadeviatheMSSSI,ofthehospitalsaccredited

for Specialized Health care Training in Health Sciences has included patient safety

criteria which are related to the following clinical practices recommended in the

strategy: Hand hygiene, high-risk medications, medication reconciliations, surgical

checklistandfail-safepatientidentification.

Thedocumentfurnishedbythecenterpropermadeitpossibleforanassessment

tohavebeenmade in2012at the levelofdevelopmentor implementationof these

safepracticesbyemployingthecriteriaincludedinTable13.

78

Table13.PatientsafetycriteriaevaluatedintheaccreditationoftheNHSteachinghospitals

PointScore HH HRM MedRecon SSC PaTIden

0 Thereisnoplan/protocolinplace

1 Protocol:Yes

Date:No

Personincharge:No

Resources:Notspecified

Training:incomplete

Dissemination:exclusivelyforInternationalHHDay

Evaluation:Notspecified

Protocol:Yes

Considerevaluation,butdonotfurnishanydata

2 Protocol:Yes

Date:No

Personincharge:No

Resources:Location

Training:incomplete

Dissemination:exclusivelyforInternationalHHDay

Evaluation:Notspecified

Protocol:Yes

Considerevaluation,butdonotfurnishanydata

3 Alloftherequiredinformationiscomplete

HH: Hand Hygiene; HRM: high-riskmedications;MedRecon:medication reconciliation; SSC: safe surgery checklist; PATIden: patient identification. NHS:

NationalHealthSystem

79

Table14.Resultsofthepatientsafetycriteriaevaluatedin2012intheauditsoftheNHSteachinghospitals

Total HH HRM MedRecon SSC PatIden

0 7(13%) 8(15%) 13(24%) 6(11%) 1(2%)

1 11(20%) 26(48%) 19(35%) 18(33%) 19(35%)

2 19(35%) 7(13%) 7(13%) 10(19%) 17(32%)

3 14(26%) 4(7%) 3(6%) 15(28%) 9(17%)

Nodocumentation

3(6%) 9(17%) 12(22%) 5(9%) 8(15%)

Total 54(100%) 54(100%) 54(100%) 54(100%) 54(100%)

HH:HandHygiene;HRM: high-riskmedications;MedRecon:medication reconciliation; SSC: safesurgerychecklist;PATIden:patientidentification.

According to the data furnished by the hospitals, it has been found that nopracticeevaluatedhasbeenfullyimplemented,especiallythosehavingtodowiththesafeuseofmedication(Table14).

Therefore, itcanbesaidthatprogresshasbeenmadeoverthecourseof thelast ten years in the development of the patient safety infrastructure in the HealthRegions, especially in the creation of functional risk management units, incidentreporting systems and protocols for the implementation of safe practices. Theimplementationofsafepracticeshasentailedsomeclear-cutresults inthereductionof health care-associated infection, especially on the critical care units and in theimprovementofsomeaspectsofthesafeuseofmedications,aspreviouslydiscussed.However,roomforamajordegreeofimprovementisnotedintheimplementationofseveral safe practices, especially in primary care. The need is also noted ofworkingwithmorehighlyvalidevaluationtoolswhichwillmakeitpossibletogetamoreexactideaastotheimpactoftheactionscarriedout.

Thedatagleaned from theevaluationof the strategy carriedout todatehascontributed to the proposal of the strategic lines for taking action of the currentpatientsafetystrategy.

80

2.STRATEGICLINESOFACTION

� Strategiclineofaction1:Patiensafetyculture,humanandorganizationalfactors,andtrainingA positive patient safety-related culture in the health care institutions is an

indispensable pre-requisite for preventing and minimizing patient safety-relatedincidentsandbeingabletolearnfrompasterrorsinordertoreducetheprobabilityoftheirreoccurring.

For thepurposeof furtherenhancingpatientsafetyculture, it isnecessary tocontinue carryingout actions aimedatmeasuring andenhancing the safety climate,informingandtrainingallNHSprofessionalsinsafety-relatedaspects,fosteringtrainingineffectivecare,trainingtheworkingteamsinriskmanagement,fosteringleadershipin safety, reporting and learning from the incidents and keeping the professionalsinformation of the details of the evaluation of their medical services centers,stimulatingtheiractiveinvolvementintheenhancementsproposed.

General objective 1: Further enhance patient safety culture, human andorganizationalfactors

Specificobjectives:

1. Promote themedical servicescentersavailingofa safetyplan (theirownorinstitutional)whichactivelyinvolvesalloftheprofessionalsandisknownbyall.

2. Promote the leadership of the professionals for assuring that the patientsafetyplanobjectiveswillbeachieved.

3. Favortheevaluationofthesafetyclimateinthehealthcareorganizationsandthedisseminationof their findings,asanaid in the implementationof safepractices.

4. Fosterbasictraininginpatientsafetyofallofthehealthcareprofessionalsatalllevelsoftheirtraininganddevelopment.

5. Disseminate theknowledgeandexperiencesconcerningpatientsafety toalllevelsoftheNationalHealthSystem.

81

6. Favorthedisseminationofrecommendationsforthepurposeofpreventinghealthcarefrombeingprovidedwhichisofverylittlevalueorisharmfultopatients.

Recommendations:

• Setoutplansforactioninpatientsafetyatthemedicalservicescenterswithannualobjectives,evaluationandplanningfordisseminationoftheresults.

• Incorporate clinical leaders who will promote the implementation,developmentandevaluationof safe clinicalpracticesat the centers/on theunits.

• Includepatientsafetyasoneoftheaspectstobeaddressedintheplansfortakingonnewprofessionals.

• Periodically evaluation, byway of validated tools, the safety climate of theorganization as an aid toward knowing the weak points and strong pointsregardingpatientsafety.

• Reachaconsensusregardingaminimumbasictrainingcurriculuminpatientsafety for the professionals in the NHS which includes concepts on safeclinical practices, communicating, teamwork and health services factorswhichhaveabearingonpatientsafety.

• Promote thebasic training inpatient safetyof thehealthcareprofessionalsduring their undergraduate schooling, specialized training and continuedtraining.

• Identify,disseminateandshareatthenational,regionalandlocallevelsbestpractices,informationandexperiencesonpatientsafetybywayofdifferentmeanssuchascongresses,workshops,conferences,webpages,etc.

• Periodically disseminate the updated recommendations for the purpose ofpreventing unnecessary health care being provided which is of very littlevalueorwhichisharmfulforthepatient.

82

� Strategiclineofaction2:SafeclinicalpracticesDifferent international organizations have recommended different safe

practicesonthebasisof thefrequencyof themost frequentadverseeventsandtheexistingevidencefortheircontrol.WithintheframeworkofthePatientSafetyStrategyandincollaborationwiththeHealthRegions,theMSSSIhasbeenpromotingdifferentsafepracticesinkeepingwiththeinternationalrecommendations.

The safe practices recommended in this strategy are mainly those aimed atpromoting the safe use ofmedications, preventing health care-associated infectionsandpreventingtheharmassociatedwithsurgeryorpatientcareprocedures,whicharethe main factors associated with the adverse events according to the differentepidemiological studies conducted at the national level 5,26,27,28,29. Other practicesrecommended herein, such as appropriate patient identification, effectivecommunicating or the safe use of ionizing radiation also contribute to preventingavoidable adverse events. The inclusion of recommendation on the adequatemanagementofsevereadverseevents is inkeepingwithawidespreadfeeling intheNHSastoitbeingnecessarytodealwiththisproblem.

Generalobjective2.1:Promotesafemedicationuse

The activities of pharmacovigilance, training and updating of physicians andnurses in therapeutics and clinical pharmacology or the prevention of errors in themedicationcircuitsaresomeoftherelevantinitiativesforfurtherenhancingsafetyintheuseofmedications.

Thee-prescription is usefulwhenassociatedwith supporting clinical decision-makingprogramsforreducingtheerrorsresultingfromanincorrectprescriptionandcan also even appreciably enhance the treatments being followed193. The computerapplications can also provide the information and the instructions necessary forcorrectlyadministeringthemedications.

High-risk medications have a greater probability than other types ofmedicationsofbeingassociatedwithadverseeventsof severeconsequences for thepatients. The health care institutions must identify these medications, set outproceduresfortheirsafemanagementinallofthecare-providingprocesses,evaluatethe procedures implemented for specific groups ofmedicines and take specific risk-reducingmeasures.

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Chronic patients, especially polymedicated patients, are more vulnerable tomedication errors and must therefore be given special care and require a clinicalreview being made of the medication regarding both the effectiveness of thetreatments and the adherence to the same. One internationally recommendedpracticeaimedatreducingmedicationerrorsincare-providingtransitions,particularlyusefulinthesepatients,ismedicationreconciliation.Thisisaformal,multidisciplinaryprocesswhichisaimedatachievingthattheinformationwhichisconveyedconcerningthe medication at the points of care-providing transfer will be one in the same,accurateandcomplete194.Thisprocessmustbecarriedoutwiththeparticipationofalloftheprofessionalsresponsibleforthepatientinquestionandwiththepatientand/orcaregiverproper,wheneverpossible.Thiswouldalsomakeitpossibletoevaluatetheadherenceand/orlackofcomprehensionofthetreatments.

Thepatientsandtheircaregiversplayafundamentalroleinmedicationsafetyand thereforemust be informed so as to be able to assume responsibility for theirtreatment.Thepatientsmustbepreparedtoserveasabarrierforpreventingpossiblemedicationerrorswhichoccurinotherprocesses,especiallyforpreventingtheirownerrorsduringtheprocessesofadministeringthemediationsintheirownhomes.

The analysis and management of the medication errors detected by thehealth care professionals in the course of their activity is an essential strategy forfurtherenhancingthequalityandsafetyofthesystemfortheuseofmediationsandakeyelementforthecreationofasafetycultureatthelocallevelwhichmustcontinuebeingmaintainedforthepurposeoffacilitatingthesharingofexperiences,conveyingthelessonslearnedtotheentireNHSandpreventingthesameerrorsfromonceagainaffectingotherpatientsinthefuture.

Specificobjectives:

1. Promotee-prescriptionsassistedwithclinicaldecision-makinghelpsystemsofproveneffectiveness.

2. Fostertheimplementationofsafepracticeswithhigh-riskmedication.

3. Promotemedicationreconciliationduringthecare-providingtransitions.

4. Encourage initiatives being taken for further enhancing safety in the use ofmedication, especially in polymedicated chronic patients and in pediatricpatients.

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5. Promotethetrainingofhealthcareprofessionalsconcerningthesafeuseofmedications.

6. Promote the training of the patients/caregivers concerning the use ofmedicationsandtheiractiveinvolvementinthetreatments.

7. Promotethereportingofincidentsrelatedtotheuseofmedicationsthroughtheexistingreportingsystems.

8. Promote the self-evaluation of the safety of the system for the use ofmedicationsatthemedicalservicescenters.

Recommendations:

• Carry out actions for implementing e-prescription programs which includeclinicaldecision-makinghelpsystemswhichare integrated into themedicalservices center information systems and are available for all of theprofessionalsinvolvedinthecarebeingprovidedforthepatientinquestion.

• Set out specific interventions aimedat preventing themost frequent errorsinvolvinghigh-riskmedications.

• Standardize the procedures for preparing and administering injectablemedicinesandparenteralnutrition.

• Systematicallyreviewthemedicationinthepolymedicatedchronicpatientsinordertodetectorpreventadverseevents,guaranteepropermedicationandfurtherenhanceadherencetothetreatment.

• Setout recommendationsconcerning theuseofabbreviations, symbolsandphrasingusedintheprocessofprescribingandadministeringmedicines.

• Determinespecificinterventionsaimedatpreventingmedicationerrorsinthecareprovidedforpediatricpatients(training,disseminationofguides,etc.).

• Reconcile the medication during care-providing transitions, especially inpolymedicatedchronicpatientsand inhigh-riskpatients.This reconciliationmust involve the collaboration of all of the people involved (professionalsresponsible for the patient in question, patient/caregiver, communitypharmacy,etc.).

• Carryouttrainingactionsofferedforthehealthcareprofessionalsconcerningthesafeuseofmedications.

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• Carry out programs for informing and training the patients/caregivers,especiallythosepolymedicatedorthosetakinghigh-riskmedications,atallofthecare-providinglevels.

• MaintainandfurtherenhancethereportingoferrorsandincidentsinvolvingmedicationswhichoccurintheNHSbywayoftheexistingreportingsystems,includingtheanalysisandevaluationsoftheinformationgeneratedandthedisseminationoffittingrecommendations.

• Create the necessary collaboration with the pharmacovigilance centers sothat the errors involving harm will be notified to the SpanishPharmacovigilanceSystem.

• Conduct periodic self-checks on the safety of the system for the use ofmedications by employing standardized tools and setting outrecommendationforimprovement.

• Increase the surveillance and supervision of the safe use ofmedications onthepartofthepharmacyunitsandservices.

Generalobjective2.2:Promotesafepractices forpreventingandcontrollinghealthcare-associatedinfections

Health care-associated infections affect 5%-10% of all patients admitted toacutehospitalsandinvolveahighrateofmorbimortalityinadditiontoanincreaseincare-providing costs. Theexperience gainedover the courseof the last fewyears inSpain goes to show that the prevention and control of health care-associatedinfections is based on the following aspects: an adequate surveillance system,employingstandardsofcareofproveneffectivenessandtheappropriate,reasonableuseofantibiotics.

Likewise, this experience goes to show a need for an interdisciplinary effortincludingeverything from themanagementandadministrationof the centers to theprofessionalswhoperformtheirprofessionaldutiesinallfieldsofhealthcare.

Health care-associated infections are occasionally related to implantablebiomedicaldevices (catheters,woundvacs,prostheses, implants,etc.), the feasibilityand functionalityofwhich is seriouslycompromisedby infection.Themains typesofhealthcare-associated infectionsarerelatedto invasiveproceduressuchas: surgicalsite infection, catheter-related urinary infection, Central line-associated bloodstreaminfections(CLABSIs)andventilator-associatedpneumonia.

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Employing specific multimodal strategies has shown itself to be useful inpreventing these infections, it therefore being necessary to continue promoting theprogramswhichhavebeengottenunderwayfortheircontrol.

Concerningreportingoutbreaksornewresistantpathogens,itisnecessarytopromoteearlytransmissionofinformation.

The process of combatting antimicrobial resistance must be approached byway of an effective, multifaceted, multidisciplinary strategy actively involving thedifferentsectorsandprofessionalsfromdifferentspecialties.

Specificobjectives:

1. MaintainandpromotetheexpansionoftheNHSHandHygieneprogramtoallmedicalservicescenters.

2. Maintain and promote the programs for the prevention health care-associated infections in critical patients and alos expanding them to otherareasofhospitalizationusingthesurveillanceandcontrolsystemsinplaceatthemedicalservicescenters.

3. PromoteaprogramforthepreventionandcontrolofsurgicalsiteinfectionattheNHSlevel.

4. Promote and implement programs for the rational, optimized use ofantimicrobialdrugs.

5. Promote the prevention and control of antimicrobial resistances, focusingspecial attention on the control of the diffusion of multiresistantmicroorganisms.

6. Favor multidisciplinary strategies for the early detection and treatment ofsepsis.

7. Promote programs for the prevention and control of infections within thesocialservicemedicalservicescentersetting.

8. Promotethesystemsforthesurveillanceofhealthcare-associatedinfectionsfor making the control of their evolution and the comparability of resultsamongcentersandservicespossible.

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Recommendations:

• Maintain and consolidate the actions carried out for further enhancingadherence to hand hygiene by professionals and patients/caregivers, inhospitals,primarycareandsocialhealthcareservicesandnursinghomes.

• Carry out actions for the appropriate use of antiseptics anddisinfections atthemedicalservicescenters.

• Set out actions for the proper cleaning, disinfection and sterilization ofmedicalmaterial.

• CarryoutanationalprogramincollaborationwiththeHealthRegionsforthepreventionandcontrolofsurgicalsiteinfectioninselectedprocedures.

• MaintaintheprogramscarriedoutforpreventingandcontrollingCLABSIsandventilator-associatedpneumoniasoncriticalcareunitsaswellasdevelopingsimilar programs in other areas of hospitalization adapted to theircharacteristics.

• Carry out actions for preventing and controlling catheter-related urinaryinfectionsonunitsinvolvingaspecialrisk.

• Maintain and expand the existing programs for the prevention of infectionandtransmissionofmultiresistantmicroorganismtodifferentcare-providingunits,especiallytothosewhicharehigh-risk(criticalcare,dialysis,etc.).

• Carry out programs for optimizing antibiotics in keeping with the StrategyPlan for action for reducing the risk of selection and dissemination ofresistancestoantibiotics.

• Carry out programs for preventing and controlling peripherally-insertedvenouscatheter-associatedphlebitis.

• Setupspecialprogramsforcontrollingandpreventinghealthcare-associatedinfectionsatsocialservicesmedicalservicescentersandlivingfacilities.

• Get specific actions under way for the early detection and treatment ofpatients with sepsis/severe sepsis and septic shock taking into accountmultidisciplinaryinvolvement.

• Set up teams (multidisciplinary teams, as a priority) at themedical servicescenterswhicharespecialized inthesurveillanceandcontrolofhealthcare-

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associated infections and which are in keeping with the NHS surveillanceprogramsguidelines.

Generalobjective2.3:Promotetheimplementationofsafepracticesinsurgery

The effective implementation of the safe surgery checklist requires specificmultimodal and multidisciplinary strategies which include this checklist beingappropriatelycompletedandusedfordetectingincidentsrevolvingaroundthesurgicalact.Thisisamatterofasimple,efficientandeffectivemeasureforfurtherenhancingpatient safety in the surgical procedure by facilitating full compliance with theuniversal protocol (right patient, right procedure, right site) and the prevention ofsurgical site infection. The safe surgery checklist transcends the simple safetyenhancement check and improves the communications and teamwork involved andshouldbecompletedinfullatleastinelectivesurgery.

Full compliance with the Helsinki Declaration on patient safety inAnesthesiologywould serveas a stimulus forpromoting theuseof the Safe SurgeryChecklistonbeingincludedunderSection4ofsaidDeclaration.

Specificobjectives:

1. PromotetheimplementationandcorrectuseoftheSafeSurgeryChecklist.

2. PromotetheadoptionoftherecommendationsoftheHelsinkiDeclarationonpatientsafetyinanesthesiology.

3. Promote the specific training in non-technical aspects (communication,teamwork,etc.)amongthesurgicalblockprofessionals.

4. Improve communication in the transfer of the patient from the operatingroomstorecoveryorintensivecareunit.

Recommendations:

• CarryoutactionsattheNHSmedicalservicescentersfortheimplementation,adaptation, appropriate use and evaluation of the Safe Surgery Checklist,bothinhospitalsurgeryandextrahospitalsurgery.

• Promote the marking of the surgical site as a routine practice as well asrecommendationstothepatientsinthisregard.

• Disseminate and implement the Helsinki Safety in Anesthesiarecommendations.

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• Carryouttrainingactionsforthesurgicalblockprofessionalsinnon-technicalaspects(communication,teamwork,etc.).

• DevelopandimplementapatientstatuslistontransferfromoperatingroomtoRecoveryorintensivecareunit,especiallyinpatientswithseveresystemicdisease.

• Carry out measure for improving the prophylaxis of venousthromboembolism.

Generalobjective2.4:Promotetheimplementationofsafepracticesinpatientcare

Theobjectivessuggestedinthisregardhavenotasyetbeenfullyachievedtodate,thedegreetowhichachievedhavingvariedgreatlythroughoutthecountry.Allofthisentailstheneedofsystematicallypromotingproceduresfortheimplementationofsafepracticesofproveneffectivenessinthenursingcareprovidedforthepatients.

Specificobjectives

1. Foster individualizednursingcareplanssuitedtoeachpatient’sneedsbeingcarriedout.

2. Promote the inclusion of patient safety aspects in the care plan on thepatient’smedicalrecordandonthedischargereport.

Recommendations

• Develop a personalized care plan (in hospitalized patients or homecarepatients)whichaddressesat least the followingaspects relevant topatientsafety:

o Preventingfallsandrelatedinjuries

o Preventingpressureulcers

o Preventinghealthcare-associatedinfections

o Safetyinphysicallyrestrainingthosepatientswhosorequire

o Preventingmalnutritionanddehydration,especiallyinelderlypatients

o Preventingbroncho-aspiration

o Safelycaringforfrailpatients

o Preventingandcontrollingpaintheadultsandchildren,tendingtotheneedsandpreferencesofthepatientsandtheircaregivers

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• Include actions in the care plan for informing the patients and caregiversregardingthecareprovidedandtherisksinvolved.

• Includeinthecareplanforthepatient’smedicalrecordanddischargereportthe evaluation of the patient’s risks due to their clinical situation and theimplementation of the care necessary for the prevention and treatmentthereof.

• Develop specific care plans which include the integral assessment of thepatientsinhomecare,restrainedpatientsandterminalpatients.

Generalobjective2.5:Promotesaferpatientidentification

Theshortcomingsinidentifyingpatientsentailriskswhichmayleadtoincorrectdiagnoses,testsbeingconductedorsurgicalproceduresbeingperformedormedicinesorhemoderivativesbeingadministeredtothewrongpatients.

Safe patient identification of all patients must be guaranteed by means ofappropriatemethodswhichmake it possible to confirm the patient’s identity everytimeaprocedureisperformed,especiallyifitisaninvasiveprocedure195.

Specificobjectives:

1. Promote the safepatient identificationof the right patient, right procedureandrightsite.

2. Promote safepatientidentificationofthepatientswhohavespecificrisks.

3. Assuresafepatientidentificationofbiologicalsamples,whicharedeterminingfactorsforthediagnosis.

4. Fosterthefail-safeidentificationofthepatient’sclinicaldocuments.

Recommendations:

• Developandimplementactionsfor safepatientidentification,including:

o Using at least two unique identifiers for the patient. Preferably usingautomatedmeansofidentification.

o Checking the patient’s identification for each procedure, especially forthosewhicharehigh-risk.

o Settingoutstandardizedsystemsforsafepatientidentificationandthoseentailingspecificrisks.

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o Training the personnel in the appropriate procedure for identifyingpatientsandtheneedofverifying their identification,at least inviewofanyinterventioninvolvingarisk.

o Getting the patient/caregiver actively involved in the identificationprocess.

o Making an evaluation and conducting a follow-up on the identificationprocess.

• Assure the safe identification of newborns before they leave the deliveryroomandthatthisidentificationbemadeinthepresenceofthemotherorafamilymember,wheneverpossible.

• Check the identification of documents of of each patient during the care-providingprocess.

• Label thebiological samples and imaging tests at theexactpoint in timeatwhichtheyaretaken.

• Set out actions which assure traceability of both solid and liquid biologicalsamples,whetherornottheybereplaceable,whicharedeterminingfactorsforthediagnosis,fromtheveryoutsetofthesamplebeingtaken.

• Determine mechanisms at the hospital and ambulatory level of care, foridentifying unidentifiable patients and suitably distinguishing among thosewhohavesimilaridentifiers(samename,etc.).

Generalobjective2.6:Promotecommunicationamongprofessionals

In the course of the care-providing process, it must be assured that theinformationconveyedamongprofessionalsconcerningthepatient’sclinicalsituationisaccurate,adequateandisprovidedtotherightperson.

Conveying clinical information on patients, especially during the transition ofcare, isahigh-riskprocess inwhich thekeyelement involved iscommunication.Thebreakdowns in communication among professional comprise the factor most ofteninvolvedinsentineleventscauses196.

The standardizationof the communicatingprocedureduring thetransitionsofcare, minimizes the variability of the messages and favors the efficacy of thecommunication,contributingtoalloftheprofessionals involved inthetransferbeingawareofthepatient’soverallsituationandtheerrorsbeingreduced197.

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Specificobjectives:

1. Promote standardized communication, bothwithin the units and during thetransitionofcareforguaranteeingsafe,continuedcareforthepatients.

Recommendations:

• Carry out actions for the implementation of structured communicatingtechniques.

• Setout actions for effective communicating in a timely fashionof alert andcritical values of diagnostic tests which may be lift-threatening for thepatient.

Generalobjective2.7:Promotethedesignanddevelopmentofstrategiesfordealingwithsevereadverseeventsathealthcarecenters

Whenanadverseeventoccurs,especiallywhenithascausedseriousharmtothe patient, the patients and their familymembers (first victims)must be providedwith support by the organization and must be furnished with the informationappropriate for the circumstances in question (open disclosure), as well as theconsequences and the actions to be carried out for providing a response to theirneeds. In turn, the health care professionals involved in an adverse event (secondvictims)mustbeabletorelyoninstitutionalsupportsoastobeabletoopenlyreportwhathashappenedandmustbefurnishedwithsupportfortheirintegrationintothecare-providingendeavorwithoutanyaftereffects.

Thehealthcareorganizationsshouldtakeaproactivepositionwhichisastepahead of the situations involving conflicts, availing of protocols and procedures foradequately responding to patients and professionals when a severe adverse eventoccurs, additionally taking into account actions for maintaining or restoring theorganization’s(thirdvictim)prestigeandtheconfidenceoftheorganization’susers.

Specificobjectives:

1. Promotestrategiesbeingcarriedoutformanagingsevereadverseeventsandsupportingthevictimsthereof.

2. Promote the training of the professionals for the purpose of being able toappropriatelycarryoutsaidstrategies.

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Recommendations

• Setoutstrategiesfortheappropriatemanagementofsevereadverseeventswhichwillassure:

o Providing the patients and caregivers who have experienced a severeadverse event with timely, clear, sincere and fitting informationconcerningwhichhashappened,aswellasaplanforprovidingsupportfortheirneeds.

o Offering support to the health care professionals involved in a severeadverseevent.

o Appropriately managing the process of conveying information to theorganization and to the media for the purpose of restoring theconfidenceintheinstitution.

• Carry out training actions for the professionals and the managers of themedicalservicescentersconcerningaspectsofprovidingcareforthepatientsandprofessionalsinvolvedinsevereadverseevents.

General objective 2.8: Promote the safe use of ionizing radiation in clinicalprocedures

Thedevelopmentoftechnologiesemployingradiationinthefieldofmedicinehas given rise to some major improvements in the diagnosis and treatment ofdisorders involving a major benefit for patients. The use of these technologies hasbeenincreasingovertheyearsinsuchawaythatmedicalexposuresarecurrentlyoneof the sources of artificial radiation which contribute the most to the population’sexposure198.

Withinthiscontext, the internationalorganizationssuchastheWorldHealthOrganizationandtheInternationalAtomicEnergyAgency(IAEA)havepromotedPlansforActionfortheRadiologicalProtectionofPatientsinthehealthcaresector199,200.

Therefore, at the national level and on the basis of that which is set forthundertheFrameworkAgreementbetweentheMSSSIandtheNuclearSafetyCouncilconcerningcollaborationonthesubjectsofmedicalexposures, linesofpatientsafetyare proposed in this area for the purpose of promoting the safe, controlled use ofionizingradiationintheNHS.

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The strategy lines further expandupon thatwhich is set out under the newEuropean Directive on Radiological Protection approved in 2013201, as well as thespecificnationalRegulations202,203,204,205.

The above additional reflect the pillars of the radiological protection ofpatients (aboveall, thosemosthighlyvulnerable, suchaspediatricpatients)and theheightening of awareness and adaptation, in conjunction with the auditing, whichwere agreed at the latest International Conference for Radiological Protection ofPatients206.

Specificobjectives

1. Promote actions for further enhancing the processes justifying the use ofionizingradiation,especiallyinpatientsunder18yearsofage.

2. Promote Patient Safety in the diagnostic and therapeutic proceduresinvolvingtheuseofionizingradiation.

3. Promotethedetectingandpreventionoftheadverseeventsduetoionizingradiation, especial in radiation therapy and in interventional radiologyprocedures.

Recommendations

• Carryoutactionsfortrainingandinformingtheprescribingphysicians intheuseofproceduresinvolvingionizingradiation,especiallyinpatientsunder18yearsofage.

• Set out protocols for conducting diagnostic tests and treatments involvingionizingradiation,especiallyinpatientsunder18yearsofage.

• Setoutprotocols,takingintoaccounttheALARAcriteriafortheoptimizingofradiological protections and the use of updated reference levels for theprocess of conducting diagnostic tests and treatments involving ionizingradiation,especiallyinpatientsunder18yearsofage.

• Make certain that Quality Assurance Programs are carried out in all thoseservicesworkingwith ionizing radiation, especially in the radiation therapyservices, which include risk analyses and management of the incidentsreported.

• Setoutprotocolstobefollowedbypatientswhohavebeengivenhighdosesofradiationininterventionalprocedures.

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• Furnish patients with prior information concerning the risks related to theprocedureswhichemployionizingradiation.

• Set out and promote the dissemination of a guide as to indications forcorrectlyrequestingimagingdiagnostictesting.

• Favor the patient’s clinical documentation including information beingrecordedoneachoneoftheprocedureswhicharecarriedoutwithionizingradiation (dose received, activity and route for administration of radiologydrugs, description of the technique employed and distribution of doses inradiationtherapyandbrachytherapy).

• Periodicallyconductareviewtomakecertainthattheequipmentisinproperworking order so as to guarantee the least amount of ionizing radiationpossible in the diagnostic procedures, aswell as optimized distributions inradiationtherapy.

• Makecertainthattheincidentsrelatedtoradiationtherapyarereportedandproperlymanaged(attheveryleast,atthedepartmentallevel).

� Strategic line of action 3: Risk management andreportingandlearningsystemsThisriskmanagementisfocusedontheidentificationandanalysisofthehealth

care-associatedrisks,aswellascarryingoutplansforactionforpreventingtheserisksand informing the professionals concerning the achievements attained. This riskmanagementprovidessomehighlyusefultoolssuchastheRootCauseAnalysis,whichaffords the possibility of making an in-depth analysis of the patient safety-relatedincidents, especially the sentinel events, and of preventing these incidents fromrecurring.

Themedical services centersmust carry out specific strategies for the propermanagementofhealthcarerisks.

Thereportingsystemsaffordtheopportunityof learningfromtheexperiencesofothersforthepurposeofpreventingerrors.However,thefearandreticencesoftheprofessionals with regard to reporting these errors due to possible penalizingconsequenceshaveabearingonthequalityofthereportingsystemsandtheirbeingusedtothebestadvantage.

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Generalobjective3.1:Promoteriskmanagementatthemedicalservicescenters

Specificobjectives:

1. Promote the creation of riskmanagement units at healthcare centerswhichwill carry out strategies for the propermanagement of health care-relatedrisks.

Recommendations:

• Setup(atthe individualcenterormanagement level) functionalhealthcareriskmanagementunitsorsimilarunitswhichassumetheseduties.

• Promote different methods for identifying safety-related risks (analysis ofcomplaints and suggestions, safety rounds, review of medical records,sessionsforlearningfrommistakesmade,epidemiologicalstudies,etc.).

• Promote the training of all of the professionals in themanagement of risksandintheuseoftheriskassessmenttoolsapplicabletotheirindividualfield.

• Carry out specific risk management actions, including taking a proactiveattitudeandtheuseofamethodologywhichwillmakeitpossibletoidentifyproblems, analyze their causes and carry out actionswhichwill prevent orreducetheirbeingrepeated.

• Makein-depth,systematizedanalysesofthesentineleventsidentifiedwhichsorequire.

Generalobjective3.2:Promotetheimplementationanddevelopmentofsystemsforreportinghealthcare-relatedincidentsforpurposesoflearning

Specificobjectives:

1. Promote the implementation and development, at healthcare centers, ofsystems for reporting health care-related incidents focused on lessonlearningandproblemsolvingatlocallevel.

2. Promote strategies being carried out for further enhancing and providingincentivesforincidentsbeingreportedatthemedicalservicescenters.

3. Fosteragile,timelyfeedbackfromtheinformationtotheprofessionalswhohave taken part in reporting incidents, as well as to the rest of theorganization.

4. Foster periodic publication of information related to the safety incidentsidentifiedintheNHS.

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5. Promote the protection of the professionals taking part in the reportingsystemsfordisciplinaryorlegalproceedings.

Recommendations:

• Set up a system for reporting health care-related incidents at the medicalservicescentersorunitswhichdonotalreadyhavesuchasystem inplace,which will be voluntary, confidential and non-punitive and which willencouragelearning.

• Facilitatethosecenterswhichdohavethissysteminplacewiththeuseandsustainabilitythereofforthepurposeoffurtherenhancingthesafetyofthehealthcareprovided.

• Carryouttrainingactionsforalloftheprofessionalsfortheproperreportingofhealthcare-relatedincidents.

• Carry out actionswith themanagers and professionalswhichwill favor thereporting,analysisandmanagementof incidents related to thehealthcareprovided.

• Facilitatethereportingofincidentsbypatients/caregivers.

• Provide theclinicalprofessionalswith timely informationas to the incidentsidentifiedandtheactionstakenfortheirprevention.

• Furnish theclinicalprofessionalswith the informationon themost frequentsafety-related incidents in the NHS and the recommendations for theirprevention

• Promotefurtherexpansiononthefittingrulesandregulationsfocusingontheprotectionofthosereportingincidents.

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� Strategic line of action 4: Patient and caregiverparticipationfortheirsafetyManyreticencesstillasyetexistbothonthepartofthemanagersandonthe

part of the professionalswhich are hindering patients being actively involved in thedecision-making process and citizen participation at the group level in health care-relateddecision-making.Thisparticipation isbasedontherightwhich individuals,ascitizens, have for taking part in the decisions affecting them and their freedom ofchoicewithinthehealthsystem.

Therearealsoculturalreticencesonthepartofthepatientspropertoadoptadifferentprofileandroleinthehealthcaredeliveryprocess.

Despite the above, it is indeed true that the role of patients is changing andthat this requires a major cultural change in the professional-patient relationshipbasedontheshareddecision-makingprocess.

Generalobjective4.1:Promotetheparticipationofthepatientsandtheircaregiversinpatientsafety

Specificobjectives:

1. Promote the patient/caregiver being furnished with complete, readilycomprehensible information concerning their care delivery process and therisks entailed, facilitating a shared decision-making process with theprofessional/teamprovidingthepatient’scare.

2. Promote the training of the patients/caregivers concerning the patient’sdisorder,thecarerequiredandtherisksentailedinthehealthcareprovidedandtheirprevention.

3. Promotetheactiveinvolvementofthepatients/caregiversinpatientsafety-relatedaspectsintheircontactswiththehealthsystem.

Recommendations:

• · Have patient receiving plan in place including clear, complete,comprehensible information on their rights and obligations, the healthservicesinwhichthecarewillbeprovided,therisksentailedinthecaretobeprovidedandthepatient’sinvolvementinthedecision-makingprocess.

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• Foster specific training programs for patients/caregivers for the purpose ofachievingtheiractiveinvolvementinthedecision-makingandcare-providingprocesses.

• Carryoutactionsforstimulatingtheparticipationofthepatients/caregiversinpatient safety-related activities (joint patient and professional committees,patients’council,etc.).

• Allow and promote the presence of a companion for the patient, providedthatthisbepossible,inallofthehealthcaresettings,especiallyinthecaseofpediatricpatientsorthosepatientswhosecognitiveabilitiesarediminished.

• Assure the correct procedure in obtaining the informed consent of thepatients, above all in invasive procedures, as well as in the process ofrecording living wills, promoting practices which will help the patient toexecutealivingwillinaninformedmanner.

• Prepareguidelinesastohowtoprovidepatientswithcarequalityandpatientsafety-relatedinformation,fosteringthetransparencyoftheinformation.

• Carryouttrainingactionsforprofessionalsontechniquesforcommunicatingwiththepatients.

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� Strategiclineofaction5:ResearchintopatientsafetyThe fields of research into patient safety should include aspects for further

enhancing the knowledge concerning: the magnitude and the characteristics of theclinical risk, the comprehension of the factors contributing to patient safety-relatedincidentsoccurring, the impactwhich theadverseeventshaveon thehealth systemand the identification of cost-effective, feasible, sustainable solutions for achievingsaferhealthcare.

General objective 5.1: Promote the further enhancement of the knowledge in thepreventoftheharmassociatedwithhealthcare

Specificobjectives:

1. Promote specific linesof research inpatient safetyatnationalandRegionallevel.

2. FosterthedisseminationofthefindingsofthepatientsafetyresearchtotheentireNHSandtothecitizenry.

Recommendations:

• Promoteresearchstudiesbeingcarriedoutwhichwillmakeitpossibleto:

o Quantify themagnitude and the characteristics of the clinical risk and therisktrends.

o Furtherenhancethecomprehensionofthefactorswhichcontributetotheoccurrenceofthepatientsafety-relatedincidents.

o Evaluate the economic impact which adverse events have on the healthsystem.

o Evaluate the impact, effectiveness and sustainability of the practices,proceduresandsolutionsimplementedforthepurposeoffurtherenhancingpatientsafety.

• Promote the identification and dissemination of cost-effective, feasible,sustainablesolutionsforachievingsaferhealthcareandpreventingincidentsharmfultothepatients.

• Favor the dissemination of the findings of the research studies conductedconcerningpatientsafety.

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� Strategiclineofaction6:InternationalparticipationSpain has been taking active part in the activities carried out by the World

HealthOrganization’sPatientSafetyProgramsincetheProgramfirstbegan,aswellasinpatientsafety-orientedactionswiththePan-AmericanHealthOrganization.SpainisamemberofthetechnicalgroupsintheOrganizationforEconomicDevelopmentandCooperation,andintheEuropeanCommission..

Generalobjective6.1:Promoteinternationalcollaborationinpatientsafety

Specificobjectives:

1. Foster collaboration with the World Health Organization’s and the PanAmericanHealthOrganization’spatientsafetyProgram.

2. Promote Spanish participation in international forums related to patientsafety.

Recommendations:

• MaintainandbolsterthecollaborationwiththeWorldHealthOrganization’sandthePanAmericanHealthOrganization’sPatientSafetyProgram.

• Maintain and bolster the collaboration with the Member States and theEuropean Commission in working groups and joint actions within theframework of the EuropeanUnion’s care quality andpatient safety-relatedactions.

• Collaborate with other international organizations which carry our relevantactionsregardingpatientsafety.

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3.EVALUATION

Fortheevaluationofthisstrategy,severalindicatorsandcriteriaarebeingagreedwiththe Health Regions and will be included in a separate document currently in theprocess,titled“Evaluationofthe2015-2020NationalHealthSystemSafetyStrategy”.

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4.GLOSSARY

• Accreditation.Formalrecognitionoftheindependenceandtechnicalcapacityof a conformanceevaluationagency for carryingout itswork inaccordancewithinternationally-recognizedrequirements207.

• Adverseevent:Anincidentwhichcausesharmtothepatient213.

• HealthRegion.Territorialentitywhich,withintheconstitutionalbodyoflawoftheKingdomofSpain,isendowedwithlegislativeautonomyandexecutiveauthorities, as well as the power of administering themselves bymeans oftheirownrepresentatives211.

• Qualityofcare.Thedegreetowhichthehealthservicesfortheindividualsorthe population increase the possibility of achieving the desired results andare, at the same time, consistent with current scientific knowledge. Thehealthsystemmustseetofurtherenhancingthefollowingareasofthehealthcare provided: effectiveness, efficiency, accessibility, acceptability (patient-centeredcare),equityandsafety209.

• Error. This refers to the fact of not carrying out a planned action or ofemploying an incorrect plan. Errors can be either errors of commission, ifsomething is done wrong, or errors of omission, if the correct thing is notdone213.

• Safe patient identification.A procedure affording the possibility ofmakingcertainofthepatient’sidentifyduringthecare-providingprocessonthebasisoftheidentificationofdetailswhichpertainsolelytothepatientinquestionandcannotbesharedbyotherpatients195.

• Handhygiene.Ageneraltermforreferringtotheremovalofmicrooganismsbywayofdisinfectingagentssuchasalcoholorsoapandwater86.

• Harmless incident. An incident which the patient experiences but whichcausesnoappreciableharm213.

• Healthcare-associatedinfection.Aninfectionacquiredasaresultofahealthcareinterventioninanyhealthcaresetting(hospital,outpatientcaresetting,living facilities, etc.) and which was not present or being incubated at thepointintimeatwhichthecarewasprovided104.

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• Health care-related harm. The harm which results from the plans ormeasures adopted during the process of providing health care or which isassociatedwiththesame213.

• High-riskmedications.Thosewhichhaveaverygreatprobabilityof causingsevereharmorevendeathwhenanerrorismadeinthecourseoftheiruse.This definition does not indicate that the errors associated with thesemedicationsaremorefrequent,butratherthatintheeventanerrorisindeedmade,theconsequencesforthepatientsareusuallymoresevere216.

• Medication error. An unintentional error in the process of prescribing,dispensingoradministeringamedicineunder thecontrolof thehealthcareprofessionalorofthecitizenwhotakesthemedicine214.

• Medication Reconciliation. A formal process consisting of obtaining acomplete, accurate list of the patient’s medication prior to admission tohospitalandcomparingittothemedicationprescribedforthatsamepatientat hospital admission, in the transfers and at discharge from hospital. Thediscrepanciesfoundmustbeappropriatelyrecordedandreportedtothenexthealthproviderandtothepatientl210.

• NationalHealthSystem.CoordinatedsetofthehealthservicesoftheCentralGovernment Administration and the health services of the Health Regionswhich integratesallof thehealthcarebenefitsand functionswhich,by law,aretheresponsibilityofthepublicpowers220.

• Nosocomialinfection.Aninfectionacquiredduringahospitalstaywhichwasnotpresentorintheincubationstageatthepointintimeatwhichthepatientwasinitiallyadmittedtohospital215.

• Patient participation. The process allowing the patients, their caregivers ortheperson towhom theydevolve their power to takepart in thedecisionsrelatedtotheirhealthconditionandinthepreventionofhealthcare-relatedharm, thus contributing to the organization’s learning by way of theirexperienceaspatients.

The term “public participation” is understood as the extension by way ofwhich thepatientsorcaregivers, throughtheir representativeorganizations,contributetoshapingthehealthsystembymeansoftheiractiveinvolvement

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in the process of designing the health policies, the preparation of healthstrategiesandthegovernanceoftheinstitutions.64.

• Patientsafety.Reductionoftheriskofunnecessaryharmassociatedwiththeprocess of providing health care up to an acceptableminimum, taking intoaccount thecurrentknowledgeat thepoint in time, theavailable resourcesandthecontextinwhichthecareisprovided213.

• Reportingandlearningsystem.Asystemrequiringthecollectionofdataandanalysisconcerningallaspectsrelatedtotheprocessofprovidingcareforthepatient inwhich therehasbeenanunanticipatedcircumstancewhich couldhavecausedorhascausedthepatientunnecessaryharm,forthepurposeofpreventingitsreoccurrencebywayoflearning65.

• Patient safety-related incident.Aneventorcircumstancewhichhascausedorcouldhavecausedapatientunnecessaryharm213.

• Patient.Apersonwho requireshealth careand isplacedunder the careofprofessionals for maintaining and/or restoring his/her health or bringingsymptomsundercontrol217.

• Procedure.Structuredmethodfordoingsomethingorperformingatask218.

• Riskmanagement.Clinical,administrativeand industrialactivitieswhich theorganizationsemploywithaviewtoidentifying,evaluatingandreducingtheriskofharmtothepatients,thepersonnelandthevisitorsinadditiontotheriskoflossesfortheorganization213.

• Risk.Likelihoodofanincidentoccurring213.

• Safepractices.Interventions,strategiesorapproachesaimedatpreventingormitigating the unnecessary harm associated with the process of providingpatientswithhealthcareandfurtherenhancingtheirsafety86.

• Safesurgery.Setofrulestobefollowedduringthesurgicalprocedureforthepurpose of guaranteeing the patient’s safety in the prevention of adverseevents related to: surgical site infection, wrong site/wrong patient/wrongprocedure, the surgical equipment, the anesthesia and the use of themedicines45.

• Safety culture. An organization’s safety culture is the result of the values,attitudes, perceptions, skills and patterns of behavior of individuals and

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groups which determine the commitment as well and the style and abilitythereof,withregardtothehealthoftheorganizationandthemanagementofsafety212.

• Sentinelevent.Anunanticipatedincidentinwhichdeathorseverephysicalormental harm or the risk of the same being caused occurs. Severe harmspecificallyincludesthelossofalimborafunction.Thephrase“ortheriskofthe same being caused” encompasses all variations of the process therepetition of which would entail a major probability of a severe adverseoutcome.Theseeventsareknownas“sentinel”eventsbecausetheyalerttotheneedofanimmediateattentionandresponse213.

• Specialized Care Activity Register-MinimumBasic Data Set (RAE-CMBD inSpanish):RoyalDecree69/2015ofFebruary6governingtheSpecializedCareActivityRegister(RAEinSpanish),basedonthecurrentMinimumBasicDataSet(MBDS).Thisincludesthestandardizedrecordingofanumberofvariablesrelatedtothepatientandtothecare-providingepisodeinquestion,includingthe diagnoses and the procedures. This register encompasses bothhospitalizationaswellasthehomecarehospitalization,medicaldayhospital,outpatient surgery, especially complex outpatient procedures and hospitalemergenciescare-providingmodalities219.

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5.ABBREVIATIONS&ACRONYMS

AEMPS:SpanishMedicinesandMedicalProductsAgency

AHRQ:AgencyforHealthCareResearchandQuality

PC:PrimaryCare

CRB:Catheter-RelatedBacteremia

BURDEN:BurdenofResistanceandDiseaseinEuropeanNations

PCC:PrimaryCareCenter

ACs:HealthRegions

CHAFEA: European Commission and Consumers, Health, Agriculture and FoodExecutiveAgency

CISEM-AP:Reportingharmlesssafetyincidentsandmedicationerrorsinprimarycare

CISP:PopulationHealthResearchCenter.MBDS:MinimumBasicDataSet

MedRecon:MedicationReconciliation

AE:AdverseEvent

EARCAS:AdverseEventsatSocialservicesmedicalservicescentersandLivingfacilities

SYREC:SafetyandRiskintheCriticalPatient

EARS-Net:AntimicrobialResistanceInteractiveDatabase

ECDC:EuropeanCenterforDiseasePreventionandControl

ENEAS:NationalStudyonHospitalization-RelatedAdverseEvents

APEAS:StudyonAdverseEventsinPrimaryCare

EVADUR:AdverseEventsinEmergencyCare

FHC:Systemsforreportingandrecordingadverseevents

HELICS:HospitalinEuropeLinkforInfectionControlthroughSurveillance

HH:HandHygiene

HAIs:Infectionacquiredasaresultofahealthcareinterventioninanyhealthcaresetting(hospital,outpatientcare,livingfacilities,etc.)whichhadnotbecomeevidentorhadbeenincubatingatthepointintimeatwhichthecareisprovided(ECDC).

PATIden:PatientIdentification

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IMPLEMENT:ImplementingStrategicBundlesforInfectionPrevention&Management

INGESA:NationalHealthcareManagementInstituteforCeutaandMelilla

CPI:ConsumerPriceIndex

IPSE:ImprovingPatientSafetyinEurope

UTI:UrinaryTractInfection

JC:JointCommission

SSC:Safesurgerychecklist

HRM:High-RiskMedications

MOSPS:MedicalOfficeSurveyOnPatientSafetyCulture

MRSA:Methicillin-ResistantStaphylococcusAureus

MSSSI:MinistryofHealth,SocialServicesandEquality

NQF:NationalQualityForum

VAP:Ventilator-AssociatedPneumonia

OECD:OrganizationforEconomicCooperationandDevelopment

WHO:WorldHealthOrganization

PaSQ:Jointactionforpatientsafetyandcarequality

ABP:Alcohol-BasedProduct

PROA:ProgramforOptimizationoftheUseofAntibioticsinHospitals

PROHIBIT:PreventionofHospitalInfectionsbyInterventionandTraining

AMR:AntimicrobialResistance

SEEIUC:SpanishSocietyforIntensiveCareNursingandCoronaryUnits

SEMICYUC: Spanish Society for Intensive Care Medicine, Critical Care and CoronaryCareUnits

SGIS:Safety-RelatedIncidentManagementSystem

SINASP:PatientSafety-RelatedReportingandLearningSystem

SINEA:IncidentandAdverseEventReportingSystem

SISNOT:HarmlessIncidentReportingSystem

SNASP:PatientSafety-RelatedReportingandLearningSystem

IncidentRS:IncidentReportingSystemforLearning

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NHS:NationalHealthSystem

TPSC:PatientSafetyManagementPlatform

ICU:IntensiveCareUnit

FRMU:FunctionalRiskManagementUnit

PUs:Pressureulcers

SMU:SafeMedicationUse

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6.LISTINGOFTABLESTable1.MainENEASStudydata..........................................................................................26

Table2.Spanishstudiesonthefrequencyofadverseeventsindifferenthealthcare-providingsettings.......................................................................................................29

Table3.Top-priorityrecommendationsforfurtherenhancingpatientsafetyinprimarycare.............................................................................................................................34

Table4.AreasforworkingonpatientsafetyproposedbytheCounciloftheEuropeanUnion..........................................................................................................................38

Table5.Safepracticesrecommendedbydifferentinternationalorganizations.................42

Table6.EuropeanUnionandECDCinitiativesforcombattingHAIsandRAMs...................47

Table7.Actionscarriedoutbydifferentorganizationforfacilitatingpatientparticipationfortheirsafety............................................................................................................52

Table8Frequencyoftheadverseeventsduetomedicationsinthemulticenterstudiesconductsatthenationallevel....................................................................................57

Table9.FindingsofstudiesconductedinSpainonmedicationerrorsandadverseeventsrelatedtomedications...............................................................................................58

Table10.Top-prioritysafepracticesrelatedtomedicationssuggestedbydifferentorganizationsanddegreetowhichimplementedinSpainaccordingtothestudiesconductedin2007(n=105hospitals)and2011(n=165hospitals)withthe“Self-AssessmentQuestionnaireonSafetyintheSystemforUseofMedicationsinHospitals”...................................................................................................................60

Table11.Patientsafetystrategyindicatorsforthe2010-2013timeframe........................76

Table12.Spain’sNHSHandHygieneprogramindicators....................................................78

Table13.PatientsafetycriteriaevaluatedintheauditoftheNHSteachinghospitals.......81

Table14.Resultsofthepatientsafetycriteriaevaluatedin2012intheauditsoftheNHSteachinghospitals.......................................................................................................82

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7.LISTINGOFFIGURES

Fig.1.Listofstudiesconducted for thepurposeofascertainingthe incidenceofadverseeventsinhospitals......................................................................................................24

Fig.2.IncidentreportingsystemsdevelopedinSpain’sNHSandtheircharacteristics…….70

Fig.3.SafepracticesrecommendedinthepatientsafetystrategywhichareimplementedinspecializedcareintheNHS(includingthe17HealthRegionsandINGESA)...........73

Fig.4.Safepracticesrecommended inthepatientsafetystrategywhichare implementedin specialized care in the NHS (including the 17 Health Regions andINGESA)………………………………………………………………………………………………………………….74

Fig.5.Results of the evaluation of the patient safety indicators for the 2010-2013 timeframe..........................................................................................................................77

Fig.6.ResultsoftheevaluationoftheNHSHandHygieneindicators.................................79

Fig. 7. Evolution of the consumption of alcohol-based product in theNHS for the 2009-2013period................................................................................................................79

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