The citizens for patient safety perspective · 2011-11-14 · Andalusian Public Health School....

The citizens for patient safety perspective

INFORMES, ESTUDIOS E INVESTIGACIÓN 2011

MINISTERIO DE SANIDAD, POLÍTICA SOCIAL E IGUALDAD


INFORMES, ESTUDIOS E INVESTIGACIÓN 2011

MINISTERIO DE SANIDAD, POLÍTICA SOCIAL E IGUALDAD

Edita y Distribuye: © MINISTERIO DE SANIDAD, POLITICA SOCIAL E IGUALDADSecretaria General Técnica Centro de Publicaciones Paseo del Prado, 18, 28014 Madrid

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THIS STUDY IS THE PROPERTY OF Agencia de Calidad del Sistema Nacional de SaludMinisterio de Sanidad, Política Social e IgualdadPaseo del Prado, 18-20.28071, Madrid

MANAGEMENT COMMITTEEJoan Carles March Cerdá. Andalusian Public Health School. Concepción Colomer Revuelta. National Health System Quality Agency. Ministry of Health and Social Policy.Yolanda Agra Varela. National Health System Quality Agency. Ministry of Health and Social Policy.Jesús María Casal Gómez. National Health System Quality Agency. Ministry of Health and Social Policy.

TECHNICAL COMMITTEEJoan Carles March Cerdá. Andalusian Public Health School. Mª Ángeles Prieto Rodríguez. Andalusian Public Health School.Ainhoa Ruiz Azarosa. Andalusian Public Health School.Astrid Suess. Andalusian Public Health School.Noelia García Toyos. Andalusian Public Health School.Mª Teresa Gijón Sánchez. Andalusian Public Health School.Jesús María Casal Gómez. National Health System Quality Agency. Ministry of Health and Social Policy.

PUBLISHING COORDINATORPilar del Peso Hernández. National Health System Quality Agency. Ministry of Health and Social Policy.

This document must be cited as: The Citizens for Patient Safety Perspective. Madrid: Ministry of Health and Social Policy; 2011.

Table of Contents Introduction 7

1. “Patients for Patient Safety” Workshop/Panel of Experts 11

2. Study on the opinions, expectations and position of patients,

associations and citizens regarding patient safety and their participation 25

3. Patients for Safety in the National Health System: Declaration and

Commitment 49

4. Menorca Conference at the Public Health Summer School, Start-up

of the Citizen Trainers Network 51

5. Bibliography 59

6. Annexes 63

LA PERSPECTIVA DE LOS CIUDADANOS POR LA SEGURIDAD DEL PACIENTE 7

Introduction

Four to seventeen percent (4%-17%) of all patients who are admitted to a hospital will experience an unsuspected, unexpected accident as a result of the health care provided and not of their baseline disorder which will have consequences on their health and on their prospects for recovery. In some cases, these errors will result in death. In the U.S., it has been estimated that 44,000 – 98,000 Americans die each year as a result of medical errors 1.

Patient safety, a key aspect of health care quality, has taken on major importance over recent years for both patients and their families, who want to feel safe and confident about the health care provided, as well as for health care managers and professionals who want to offer safe, effective and efficient care.

Health care is becoming progressively more complex, is utilizing more highly complex technologies, more benefits are being provided, the diversity of the professionals and the variability of their practices is increasing, as a result of all of which, being provided with health care is entailing progressively more potential risks, despite which it must be said that millions of people are being treated successfully and safely every day.

The interest in studying and controlling the risks involved in health care is not new. Back in 1956, Moser2 called them “the diseases of medical progress”. In 1964, Schimmel3 published that 20% of all patients admitted to hospitals experience some iatrogenic injury, and that one out of every five are severe.

In 2000, the Institute of Medicine4 published the report “To Err Is Human: Building A Safer Health System”. This report revealed to the world the number of preventable medical errors occurring daily, analyzing the systemic nature of the errors and setting out prevention strategies. In 2005, the Agency for Health care Research and Quality5 presented a guide on 30 safe practices developed by the National Quality Forum.

In 2001, a W.H.O. report6 was published on the presence of adverse effects in clinical practice, in which recommendations were included for preventing and dealing with these events. In 2003, the Canadian Patient Safety Institute7 was created. The National Health Service established a specific body to deal with these matters (National Patient Safety Agency)8. In 2004, the British Agency published a document titled “7 Steps to Patient Safety”.9

In the European Union, Patient Safety was included among the objectives of

8 INFORMES, ESTUDIOS E INVESTIGACIÓN

different programs and Community actions10-12. As a result of the European Commission DG Health and Consumer Protection Conference held in 2005, the “Luxembourg Declaration on Patient Safety”11M was published, including recommendations to the European institutions, the political authorities and health care organizations of the member nations. In 2006, a special edition of the Eurobarometer12, the findings of a quantitative study analyzing the incidence of medical errors in different European countries, was presented.

Within the context of Spain, the Ministry of Health and Social Policy’s Quality Agency has promoted a line of work on patient safety: expert forums, international meetings, workshops, training measures, declarations and working agreements with the Autonomous Communities13-18. The National Health System Quality Plan’s Strategy Number 8, makes patient safety one of the key aspects of improving quality. One of the measures planned under this strategy is that of promoting patient participation therein, by developing ways of collaborating and educational activities jointly with their associations. This line of action is in keeping with the recommendations of the W.H.O. World Alliance for Patient Safety Program, which specifically sets out the “patients for patient safety” area as one of its six strategic areas. The starting point of this initiative was the patients’ meeting held in November 2005, which culminated in the London Declaration, in which the signers undertook the commitment to collaborate in achieving safer health care. In 2006, the Quality Agency published the first “National Study on Hospitalization-Related Adverse Effects”17 conducted in our country. In December 2007, the Declaration and Commitment of the Patients for Patient Safety in the National Health System18. was presented in Madrid (See Section 3).

Along with a greater presence of this subject matter within the scope of the health care policies, there has also been an increase in scientific publications19-55. These publications include monographic studies19-25, evaluations of the Patient Safety-related health programs26, 27, bibliographic reviews on the current status of this issue28-30, research studies17, 19, 31-43 and opinion articles44-56.

The research published over recent years can be divided into two types: those studies conducted for the purpose of analyzing and evaluating the incidence of medical errors or adverse effects5, 17, 19, 31-33, and the studies aimed at delving into the health care safety-related opinions and expectations of patients and professionals34-43.

In this regard, the Ministry of Health and Social Policy Quality Agency set a number of projects into motion in 2007 for the purpose of ascertaining patient and consumer perception and experience concerning patient safety and setting out participation mechanisms. Initially, a qualitative study was conducted with patients, family members, association representatives, key agents and opinion-makers, followed by two workshops in which a consensus

http://www.msc.es/organizacion/sns/planCalidadSNS/docs/Declaracion_pacientes.pdf

http://www.msc.es/organizacion/sns/planCalidadSNS/docs/Declaracion_pacientes.pdf


document was drafted on the current situation and possible priorities and lines of work in PS from the perspective of the patients and consumers were set out. Based on this document, the workshop was held as part of the Public Health Summer School, which aided toward creating the Trainers Patient Safety Citizen Network promoted and supported by the spanish Ministry of Health and Social Policy Quality Policy through the Quality Agency for the National Health System.

1. “Patients for Patient Safety” Workshop/Panel of Experts

Project Description Within the framework of the patient safety-related policies in the National Health System included in the Quality Plan for the National Health System, the need is posed of ascertaining the opinions, expectations and positions of experts and representatives from patients’ associations, consumer and user associations and of patient ombudsmen from different Autonomous Communities concerning this subject and their participation in future actions aimed at preventing risks and putting forth patient safety-related solutions.

It is within this framework that this workshop-panel of experts was held with the “Patients for Patient Safety” theme, having given rise to this report on the findings thereof.

ObjectivesTo ascertain the opinion and contributions of some patients’ associations, consumer and user associations of a national scope and patient ombudsmen from different Autonomous Communities regarding different aspects related to Patient Safety in the National Health System: specific incidents and strategies for resolving the same, Patient Safety-targeted measures, the associations’ prospects for involvement, strategies for informing on possible health-related risks and suggestions for improvement from the participation with regard to future intervention measures.

This aim was specifically set out in the following objectives:• Situation analysis and problem identification: identify the National Health

System’s patient safety-problems from the perspective of the patients, consumers and a panel of experts.

• Identification and prioritization of critical points in the chain of safety.• Identification of intervention strategies.


Methodology

Techniques employedFor achieving the objectives, a qualitative methodology based on the following techniques was employed:• Group discussion.• Panel: support for classification of information gathered through

brainstorming.• Horizon model or adapted nominal group technique: use the suggestions

generated in the brainstorming, structure the suggestions in a hierarchal manner in terms of criteria and visually evaluate the implementation.

This technique is an adaptation of the nominal group technique and includes a graphic display of the phase of structuring the suggestions into a hierarchy. This graphic display is very useful, because it affords the possibility of visually evaluating where to start implementing and to see the gap between the current and ideal situations or rather between suggestion importance and feasibility.

The criteria are voted on by assigning different point scores, thus allowing for weighting aiding toward the graphic lines providing more information. One is voted on a 1-5 basis, and the other on a 1-10 basis. The degree of agreement is calculated by means of the standard deviation on the means of the direct point scores awarded to each suggestion.

The steps followed were: a. Posing the first question. b. Individual putting forth of ideas. c. Reaching to a consensus about these ideas (by means of successive rounds). d. Classification according to their scope. e. Scoring by criteria. f. Creation of the graphic. g. Showing the graphic and analysis.

Working Session ProcedureSetting out the current situation of Patient Safety-related topics, specifically aspects closely related to the perspective actively involving the patients in patient safety.

Objective 1: Situation analysis and identification of problems.Identify the National Health System’s PROBLEMS regarding patient

safety from the perspective of the patients, consumers and the panel of experts.

Methodology: Debate.


• What aspects of “patient safety” do you think are most important?• Do you think that hospitals are safe?• What aspects are the ones which should be improved the most?

Objective 2: Identification and prioritization of critical points in the chain of safety.Methodology: • Nominal group. Individual work with cards and reaching a consensus.

- Incidence / Critical point. - Point in time in the care-providing process. - Degree of seriousness. - Presence of consequences on health.

• Group debate (Consensus form in Annex I). - Identification of the strategies employed for dealing with each one of

the incidents named. - Agents who were involved. - Evaluation of the usefulness of the strategies.

Objective 3: Identify intervention strategies.Identify patient safety and health risk management INTERVENTION

STRATEGIES by evaluating their importance and feasibility as an orientation for implementing and carrying out policies within this framework.Methodology: Horizon model• Identification of intervention strategies.• Classification by scope.• Prioritization by importance and feasibility.

RemarksBoth the patients’ associations and the consumer and user association

are selected based on the criteria of their covering a significant number of inhabitants and working to people particularly sensitive to patient safety-related issues.

The work session was held with a pleasant and relaxed atmosphere, with a major degree of participation on the part of those in attendance.

In all of the groups, the session was started with an initial round of describing incidents related to patient safety and evaluating strategies employed.


Results

Situation analysis and identification of problemsIn general, those attending the session stated perceiving a high degree of trust in the National Health System, hospital and professionals. However, the population is progressively more alert to possible incidents or errors and is more aware of its role in this type of situations. Talking about medical errors is becoming progressively more common. Similarly, once the topic had been put into context, the group participants readily recalled cases or experiences they suspected to have involved a possible error.

All of those in attendance explained close experiences of what they referred to as medical errors, which, in some cases, have been so qualified due to having had serious consequences, both physically as well as psychologically.

As is inferred for the foregoing statements, the situation analysis reveals a scenario in which everyone states having had patient safety-related experiences within the public health system. However, the analysis of the discourses reveals the differentiation among terms to still be unclear, as is noted in the use of terms such as “adverse effects”, “errors” or “cases of negligence”.

BLOCK 1 Aspects considered most important in relation to “patient safety”Patient safety is related mainly to aspects having to do with the following 6 subjects: trust, diagnosis, treatment and role of the agents involved, information and instruction, accessibility and tangibility, protocolization and coordination-related aspects.

1. Trust.• Safety as the basis of TRUST.• Lack of confidence in the organizations which do not work with processes.

2. Diagnosis.• Patient DECISION-MAKING.• DELAYS IN THE RESULTS OF THE DIAGNOSTIC TESTS.• ERRORS in diagnosis.

3. Relations and role of the agents involved.• The importance of the COMPANIONS as ERROR FILTERS is valued.• The CONCEPT OF THE MEDIATOR as a companion is revindicated.• The short length of time and a certain degree of arrogance on the part of

some physicians and, in light thereof, the need of improving the personal


RELATIONS with the health care professionals is posed as a problem. From the professionals, it is commented that neither the failures nor the lack of knowledge or the limitation of science are recognized.

• The ROLE OF THE ASSOCIATIONS for supplementary information and collaboration and the participation of ASSOCIATIONS in shared forums is posed.

• Mention is made as to the former leading role played by practicing medicine now being relegated to second place by research and its role being turned over to the pharmaceutical industry.

• Mention is made as to the LACK OF KNOWLEDGE OF THEIR OWN DISORDER on the part of patients contributes to adverse events (AE) occurring.

• Major importance is placed on heightening awareness and providing instruction concerning this matter.

4. Information and instruction.• INSTRUCTION and INFORMATION are seen as being the basis of safety.• Within instruction, the importance of instructing the health care staff in

COMMUNICATING with and in INFORMING patients is posed.• INFORMATION on the benefits and on accessibility thereto is seen as

being necessary, given that INADEQUATE INFORMATION to patients heightens their anxiety and fear, the participants therefore apparently finding it important to take into account the INFORMATION which can be provided to patients.

5. Accessibility and tangibility aspects.• Use of suitable MATERIAL MEANS.• ACCESSIBILITY, without cutting major expenses.• Facilitate patients being seen by specialists.• Make access to expensive medicines possible, if they are necessary.• Adequate allocations of RESOURCES, above all in the case of geriatric

physicians.• INFORMATION on all benefits and especially on accessibility thereto.

6. Protocolization, coordination and health care professionals.• The opinion is that the PROTOCOLS sometimes do not work, given

that some physicians do not believe in them or do not use them. In view thereof, the idea is posed of the administration acting as a guarantor, they therefore putting forth the idea that the administration must see full compliance with the protocols.

• It is considered highly important that the CRITERIA FOR TAKING ACTION be unified throughout the Autonomous Communities in relation to


the procedures, given that the DECENTRALIZATION OF AUTHORITIES has given rise to uncertainty as a result of the criteria of the Autonomous Communities varying concerning different issues (i.e. vaccines).

• Comparative inequalities among disorders are set out.• The need for IDEAS FOR IMPROVING ORGANIZATION, such as:

day hospitals for chronic patients, a chronic patient card, e-prescriptions is discussed.

• It was commented that safety matters must go beyond hospitals and hospitalization, and that safety must be an objective for all disorders and all patients.

BLOCK 2 Evaluation: Are hospitals safe?In general, those attending the workshop showed a positive attitude when the topic of the safety of hospitals was being debated. In principle, the perception of a high degree of trust in the National Health System, in both the hospitals and the health care professionals was expressed.

However, the topic of unsafeness or lack of safety at hospitals was also explained, mainly in the intervention of associations deeply affected by disorders which are progressively more alter to possible incidents or errors. Several examples were described, one of the most attention-getting of which was that related to patients allergic to latex, given that it was stated that, one hand, the hospitals had no latex-free units and, on the other, many professionals had no knowledge of the problem and what to do to deal with the same.

The aspects which were related to patient safety as far as the lack of safety of the hospitals were connected mainly with three aspects:1. Firstly, those aspects which have to do with tangible elements and

accessibility were discussed. In addition to examples such as there being no latex-free units, other aspects such as architectural barriers or the lack of cleanliness were mentioned.

2. Secondly, with health care professionals in aspects such as following up on the treatments by different professionals. In this case, circumstances in which different professionals are involved at different points in time of the process, bringing contradictory diagnoses and treatments to bear were discussed. Another perception which was brought up is the feeling of lack of teamwork on the part of the professionals and the feeling of having a greater degree of trust in some professionals than in others (physicians, nurses).

3. Lastly, aspects were highlighted which have to do with the coordination and organization of the system as regards the different levels of care. The participant referred to the delays in referrals to specialized care and


the lack of coordination among the levels. The lack of effect information channels, in turn, are added to the experience of feeling uncertain about the organization of the health care provided, meaning, from their point of view, not being certain as to the system’s efficacy.

BLOCK 3 Aspects for improvementAfter debating the situation analysis and identifying whatever problems there might be in the National Health System with regard to patient safety, an attempt was made to more specifically set out those lines on which to work in order to improved the situation defined.

An explanation is provided in following of the aspects which arose out of the different working groups:• Improve COMMUNICATION AND INFORMATION strategies with

regard to: - Clarity and resolve in diagnosis and treatment-related information. - Use of language adapted to the patient. - Training in communicating skills for professionals. - Accessible, two-way professional-patient flows of information.

• Improve COORDINATION with regard to: - Established protocols for taking action. - Coordination among professionals. - Assured care continuity: intra-level and inter-level coordination.

• Improve INTERNAL MANAGEMENT in: - Hospital releases. - Appointments. - Everyday health care. - Consultation times. - Unification of criteria for preparing reports. - Personal relationship, PROFESSIONAL TRAINING AND SKILL

in: patients from one center to another.• Improve PROFESSIONAL SKILLS and the training of professionals in:

- Professional-patient relations. - Reporting incidents. - Inter-professional coordination / unification of criteria for taking

action. - Case follow-up.

• Improve TREATMENT with regard to: - Suiting the treatment to the patient. - Medication. - Unnecessary surgical tests.


• Improves aspects of ACCESSIBILITY and MATERIAL RESOURCES: - Elimination of architectural barriers. - Usefully adapting spaces. - Repair and replacement of faulty equipment.

• Improve PREVENTION-related aspects.

BLOCK 4 Incidence/Critical point Under this heading, each participant contributed personal experiences regarding incidents having occurred in the public health system (the point in time in the care-providing process at which the incident in question occurred, concerning the degree of seriousness and involvement of health-related consequences, all taking into account the strategies which were used for remedying each one of the incidents mentioned).

Point in time in the care-providing process The point in time in the care-providing process most mentioned was the hospital stay. Nevertheless, mention was also made of the emergency services, the primary care office visits and the outpatient visits in specialized care, specifically at the points in time of diagnosis and treatment.

Agents who were involved The agents mentioned as mainly involved were: • Health care administration. • Professionals: both primary and specialized care medical and nursing staff.• All other personnel working at medical centers.• Patients, family members, caregivers.

Seriousness and health-related consequences The seriousness of the incidents was generally assessed as being highly serious. The scales range includes slightly, medium-high, highly and very serious. The health-related consequences are related directly to the assessment made of the incidents, even irreversible consequences being mentioned in some case.

Assessment of the strategies which were used to remedy the incidentsConcerning the strategies which were used for remedying the incidents, some measures were suggested which might prevent adverse effects from occurring, such as:• Informing the patient. • Encouraging/facilitating active patient involvement in clinical decisions.


• Listening to the patient, given that this is something done very little in the judgment of the participants.

• Friendliness toward the patient. • Put a proper informed consent (not defensive medicine) into practice.• Heighten the awareness of the problem on the part of professionals

and patients. On the part of patients, in the regard of their being more responsible and understanding that clinical decision is made in an environment of uncertainty. Regarding this aspect, there is a call for unity in the message and source, given that there are often different and sometimes contradictory approaches in the health-related messages.

• Protocolization (including protocolizing informing and dealing with patients).

• Improve the labeling on medicines. • Specific actions for alerting patients to interactions among medicines. • Understanding emergencies as a critical point for being vigilant.

BLOCK 5 Intervention strategy identification. Horizon modelLastly, INTERVENTION STRATEGIES were identified in patient safety and health care risk management by assessing their importance and feasibility to serve as guidance for implementing and carrying out policies within this framework. These ideas are related to the starting question of:

Could you identify those intervention strategies or actions which could improve patient safety at medical centers?

A. System for adverse effect reporting by patients• Facilitating procedures at the hospitals for the reporting of adverse effects

(AE) by patients.• More efficient and transparent medical record management. Copy of the

medical record to be kept by patient.• Reporting adverse effects regarding all that which is related to medicines.• Patient reporting on adverse effects and unsatisfactory outcomes.

B. Patient ombudsman in all Autonomous Communities • Creation of the patient ombudsman concept in all Autonomous

Communities.

C. Patient instruction in safety• Advisory as to how to report adverse effects. • Specific programs on instruction for users. • Instruction in communicating/interacting techniques. • Education for patient safety through associations and institutions.


• Patient participation in educating for health for the purpose of HEIGHTENING AWARENESS.

• Instruction of those affected and information. • Instruction and information on patient safety.

D. Patient participation in safety-related matters• Annual surveys on knowledge of patient safety and perception (by

hospitals).• Participating in post-hospital and primary care surveys.• Participation in adverse effect reporting systems. • Intervention in the heath care quality checks at the municipal, Autonomous

Community and national levels. • Setting up patient safety forums and workshops in which patients may

take part. • Participation in professional meetings. • Participation in the health system concerning issues which have a direct bearing

on users. • Participation on health councils.• Participation by legal regulation on the governments’ health decision-

making and control boards.• Collaboration in carrying out programs and strategies.• Participation in the organization: process-based working or primary-

specialized coordination.• Organization of general or sectorial forums.• Setting up the patient safety committee at hospitals with patient

participation.• Monitoring system to ensure full compliance with the lines of the patient

safety strategy.

E. Strategies for informing citizens about safety• Campaigns and meetings.• Patient safety message strategy at Hospitals.• Word of mouth. • Dissemination of information to members of the patient safety associations,

internet, newsletters, meetings/workshops, …

F. The associations’ active role• Systematic gathering of information by the association concerning adverse

effects in their group and reporting to the Health Authorities. • Systematic opinion-making (diagnosis, prevention, protocols, treatment,

dissemination, heightening awareness…) through associations and councils on which patients participate.


• Promotion of the role of interlocutor with the government as associations.• Furnishing information which will aid toward instructing as to how to file

a complaint through the association in view of an adverse effect at the hospital.

• Serve as an association-National Health System information channel. • Disseminate the safety systems of the centers and others in the association. • Unification of common criteria in the associations for the presentation

thereof to the government.• Give the associations more of a leading role.

G. Participation in the decision-making process during the office visit • Get patients actively involved in health-related decision-making. • Form part of the decision-making process in conjunction with the physician.

Patients need to be heard and be taught how to ask questions.• Know everything which has to do with their disorder and its treatment.

H. Create safety-related patient guides• Creation of guides for patients through the associations for knowing

everything about the disorder, its adverse effects and possible complications.

I. Choice of professionals:• Choose the professionals (to the extent possible …).

J. Exercise and demand rights• File a complaint whenever possible room for improvement is detected,

whenever you feel you have not been cared for properly or in order to prevent cases of inadequate care.

• Exercise rights, such as demanding accurate information on diagnoses or demanding rights as citizens and, in turn, as patients or information on the procedure (demand the information on the medical act which is going to be carried out) or avail of the results of the supplementary tests.

• Know the rights so as to be able to demand full compliance with the rules of law in force, to be able to request proper information from the health system as to how to access the services, the services available, to know the care quality indexes or to demand a second opinion.

• Have clear the degree of responsibility one wishes (is able) to assume.• In view of the waiting lists, generate laws governing maximum response times.• Demand medical, psychological and social care.

K. Creation of a patient safety monitoring system • Coordinate measures and actions, conduct studies and provide information

on the subject, etc.


The intervention strategies were grouped as following for voting: • System for reporting adverse effects on the part of patients. • Patient ombudsman in all Autonomous Communities. • Patient instruction in safety.• Patient participation in safety-related matters (working groups, forums,

health councils, committees…).• Strategies for informing citizens about safety. • Active role of the associations. • Involvement in the decision-making process during the office visit. • Creation of patient guides on safety-related topics. • Choice of professionals. • Exercise and demand rights.• Creation of a patient safety monitoring system (coordinate measures and

actions, conduct studies, provide information on the subject …).

The graph shows all of the suggested actions to have been scored high in importance by the workshop participants as a whole. The intervention strategies or actions which the participants considered most important were:• Patient participation in safety-related matters.• Involvement in the decision-making process during the office visit.• Exercise and demand rights.

On the other hand, the assessment of the current situation deviates, in all cases, from the assessment of the importance place on each intervention strategy or action.

Based on the graph, it follows, generally speaking, that there is still a great deal of work as yet to be done as regards the patient safety intervention strategies.

According to the score given to the different intervention strategies or actions, it can be estimated that those for which the importance rankings most closely near the current situation are the creation of adverse effect reporting systems, the creation of patient guides and the creation of a monitoring system.

Nevertheless, these interventions, in conjunction with patient instruction in safety-related matters, are those scored lowest in importance, although still being considered to be prime objectives.

According to the workshop participants, the aspects considered to be deviated to the greatest extent from the importance placed on them in comparison to the current situation are two key aspects. Specifically, patient participation in patient safety-related matters and the area of demanding and exercising patient rights with regard to subjects concerning their safety. In conjunction with these two interventions, the current gap with regard to


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choice of professionals, which is related directly to the exercise of rights and joint involvement in decision-making, is significant.

According to this brief descriptive analysis afforded by employing the horizon model, the workshop participants could be said to assess those actions which depend upon them or rather which are tasks which they currently perform, such as the preparation of guides for patients as being more feasible or rather because there is a manifest will to take part in the intervention strategies or measures. However, according to the gap viewed in the interventions mentioned as being farthest, it could be said that the associations still see the Government Services as distant and score the current situation of those measures depending thereon lower, such as the aspects of involvement in decision-making and demanding and exercising rights.


2. Study on the opinions, expectations and position of patients, associations and citizens regarding patient safety and their participation

Objectives• Ascertain the opinions, expectations and position of patients, associations

and key agents with regard to different patient safety-related aspects in the National Health System (specific incidents and strategies for remedying the same,Patient Safety-targeted measures, strategies for informing on possible health-related risks and prospects for involvement in preparing patient safety-related policies).

• Delve into the expectations and suggestions for improvement of the participants with regard to future intervention measures.

Methodology

Study DesignThis study was conducted employing a qualitative methodology, using the focal group (FG) and semi-structured survey (SS) technique. The methodology selected affords the possibility of understanding the perspective of those taking part in the study, by capturing and reconstructing the particular meaning which each one attributes to patient safety and explaining their position regarding the issues posed. Very few studies have been conducted on this topic with this methodological focus46.

This study was carried out during the October 2006-March 2007 period in four Autonomous Communities: Andalusia, Balearic Islands, Galicia and the Basque Country.

Two participant profiles were considered: 1. Patients who had all had a recent hospitalization experience, some with mild

disorders and others with severe disorders; some believing or suspecting


to have experienced an adverse effect (AE) during hospitalization, and others not so.

2. Individuals holding executive posts in patient associations.

The patients were invited to take part through different associations, which were provided with a profile for selecting the participants in the FGs. A total of 6-10 patients took part in each FG. In all of the groups, the presence of patients with mild and severe disorders, of different ages and genders and patients both with and without a subjective experience of having had an adverse effect, was assured. A total of four (4) FGs were held in different Autonomous Communities. A total of 20 surveys were additionally conducted of individuals holding executive posts in the major patients associations. Those associations dealing with the problems affecting more individuals and which had a keen awareness of this subject were selected. To this end, the Ministry of Health was requested to furnish a list of the associations which were collaborating in the Patient Safety Strategy. In all, a total of 15 semi-structured surveys were conducted.

The AE working definition which was conveyed to the associations to be used in the patient screening process was that of the national Study on hospitalization-associated adverse effects17: any unsuspected, unexpected accident included in the medical record which has caused an injury and/or disability and/or lengthier stay and/or exitus which stems from the care provided and not from the patient’s baseline disorder. In our study, the requirement of being included in the medical record was not used, given that this aspect is not known to the patients.

The FGs and the SSs were conducted following a script. They were recorded and transcribed. The participants’ informed consent was rendered in all cases.

The information gathered was analyzed by means of a content analysis in a NUDIST-4 software environment.

Structural SampleParticipant ProfilesThree main profiles were considered:• Patients and family members (not belonging to any association).Two variables were considered:

- Degree of severity of the disorder (mild/severe). - Experienced incident (yes/no).

• Associations/federations: - Patient associations.


- Patient federations, leagues and coalitions. - Consumer and user associations.

• Key figures and opinion leaders: - Ombudsmen and consumer defense officials. - Individuals responsible for the health pages in the major newspapers

of nationwide distribution. - Key radio and t.v. journalists. - Individuals heading Autonomous Community User/Patient Assistance

Services and key professionals from these services. - Psychologists/Sociologists. - Individuals in charge of population-level market studies. - Representatives from the Spanish Patient Forum and the Catalunyan

Patient Forum.

Activities CompletedThe following activities were carried out during the data collection

phase:

1. Patients and Family MembersFour focal groups were held in different Autonomous Communities

(Balearic Islands, Galicia, Basque Country and Andalusia).

DEGREE OF SEVERITY OF THE DISORDER.Group 1: Mild disorder and experienced incident.Group 2: Severe disorder and experienced incident.

EXPERIENCE OF INCIDENTGroup 3: Mild disorder, no incident experienced.Group 4: Severe disorder, no incident experienced.

2. Patient AssociationsIn this profile, semi-structured surveys were conducted in addition to

a workshop with representatives from patient and consumer associations of the greatest social penetration, as well as with representatives from federations of associations.

Semi-structured surveys: • Coalición de Ciudadanos con Enfermedades Crónicas [Coalition of

Citizens with Chronic Diseases].• Asociación Española contra el Cáncer [Spanish Association Against

Cancer].• Confederación Española de Agrupaciones de Familiares y Personas con

Enfermedad Mental (FEAFES). [Spanish Confederation of Groups of Family Members and Persons with Mental Disease].


• Liga Reumatológica Andaluza (LIRA) [Andalusian Rheumatology League].• Parkinson Galicia.• Asociación Galega de Hemofilia [Galician Hemophilia Association].• FACUA-Consumidores en Acción [Consumers in Action].• Confederación de Consumidores y Usuarios (CECU). [Confederation of

Consumers and Users].Workshop:

• Federación Andaluza de Asociación de Laringectomizados [Andalusian Federation of Laryngectomized Patients Associations].

• Asociación de Granada y Provincia de Limitados de la Voz. [Association of the Voice-Impaired of the Capital and Province of Granada].

• Federación de Asociaciones de Espina Bífida e Hidrocefalia de Andalucía (FAEBA). [Federation of Spina Bifida and Hydrocephalus Associations of Andalusia].

• Federación Granadina de Personas con Discapacidad Física y Orgánica (FEGRADI) y Confederación Andaluza de Minusválidos Física (CAMF-COCEMFE). [Granada Federation of the Physically and Organically-Disabled and Andalusian Confederation of the Physically Handicapped].

• Federación de Ayuda a la Drogodependencia y Sidad de Granada (FADYS). [Granada Federation of Help for Drug Dependence and AIDS].

• Asociación de Pacientes Anticoagulados (APAG). [Anticoagulated Patients’ Association].

• Liga Reumatológica Andaluza (LIRA) [Andalusian Rheumatology League].

• Asociación Cordobesa de Enfermos de Artritis Reumatoide (ACOARE) [Cordoba Association of Rheumatoid Arthritis Patients].

• Federación Andaluza de Enfermedad Renal Crónica Alcer. [Andalusian Chronic Kidney Disease Federation].

• Asociación en Defensa de la Atención a la Anorexia Nerviosa y Bulimia (ADANER- Granada) [Association in Defense of Anorexia Nervosa and Bulimia Care].

• Asociación de Familiares de Enfermos Duales (AFEDU). [Association of Dual Patient Family Members].

• Asociación Andaluza Contra la Fibrosis Quística. [Andalusian Association Against Cystic Fibrosis].

• Federación Andaluza de Asociaciones de Enfermos de Corazón (FAAEC). [Andalusian Federation of Heart Patient Associations].

• Federación de Asociaciones de Esclerosis Múltiple de Andalucía (FEDEMA). [Andalusian Federation of Multiple Sclerosis Associations].

• Asociación Granadina de Esclerosis Múltiple (AGDEM) [Granada Multiple Sclerosis Association].


• Asociación Granadina de Diabetes (AGRADI) [Granada Diabetes Association].• Centro Provincial de Drogodependencias de Granada (CPD) [Granada

Provincial Drug Dependence Center].• Familiares de Enfermos de Alzheimer (AFA ALTAMID) [Alzheimer’s

Patient Family Members].

3. Key Agents and Opinion LeadersA total of eight (8) semi-structured surveys were conducted with key

agents and opinion leaders from the following sectors:• Media:

- Radio Nacional de España (1). - TeleMadrid.

• Psychologists (1).• Professionals from the User Assistance Service (UAS) (1).• Individuals responsible for market studies (1).• Ombudsmen / consumer defense officials (2):

- Ombudsman – Responsible for health-related matters. - Extremadura Public Health System User Ombudsman.

• Individuals in charge of Patient Forums (2): - Person responsible for the Spanish Patient Forum. - Person responsible for the Catalunyan Patient Forum.

The survey scripts were designed based on a criteria of common issues in conjunction with specific questions according to the survey format (individual, group, in-person, telephone, etc.) and the subject surveyed (representatives from associations, opinion leaders, etc.).

All of the scripts used in this study are attached in Annex 1.

Data AnalysisAll of the surveys and focal groups were recorded and transcribed. A discourse analysis was made based on emerging dimensions of the discourse of those surveyed. The results were triangulated by different members of the research team.

Ethical AspectsAll those surveyed were informed as to the objectives and contents of the audit and were provided with an informed consent form (See Annex II). Permission was also asked verbally to record the surveys and focal groups.


ResultsSafety concept: What do the patients and their representatives understand by the word “safety”.

On asking the patients and association representatives regarding the concept of “safety” within the clinical scope, a certain degree of difficult defining this term was noted at first. In general, the patients show two different attitudes. The first is expressed as “you have to trust”, they assuring that, to start with, they are confident and feel safe. The second is stated as “to err is human and it can happen” used with examples and specific life experiences which occurred during the hospital stay and was progressively causing them to feel unconfident and fearful as the days went by in the hospital.

All those surveyed, including those who had been contacted based on the criterion of not having experienced any AE, related specific experiences which they interpreted as being errors experienced in the hospital.

Whilst the criterion of having previously experience an AE did not give rise to any significant difference in the discourse, differences were indeed found between the patients with acute disorders and those with chronic disorders. In the case of acute disorders, the term “safety” as defined as the absence of errors in the care provided. On the other hand, those with chronic disorders stated “safety” as also being “feeling that the professionals care about and take an interest in you”, that “the patient avails of the information he/she needs”, and “that the emotional or psychological needs are cared for” and that “no administrative mistakes occur”. The patients with chronic disorders stress feeling a special lack of confidence in the care for health problems outside of their chronic disorder.

The representatives of patients associations link the “safety” concept to “error”, “lack of information”, “not being treated like a human” and “feeling of being unprotected”.

In general, the patients seems to approach the health system with an attitude of “you have to trust” and “to err is human”, whilst a frequent perception of lack of confidence and fear regarding possible mistakes is also noted in their discourse.

- Safety is not a demand on the part of the users or associations, and posing the problem may be a problem in itself. (Spanish Patients’ Forum).

- Patient safety is a complicated subject. (Catalunyan Patients’ Forum).- It’s so ambiguous. (Galician focal group).- A new issue. Not much is known about it. (Psychologist).- Safety is something multi-causal. (Spanish National Radio & TV

representative).


- Safety is something that, because it is intangible, in terms of health, it greatly concerns those of us who, being chronic patients, are constantly using the public health system. (Coalition of Chronic Patients).

- A patient only knows about safety-related matters when safety has failed for some reason (i.e. when they are the victim of some error or when, in view of a problem the patient considers to be important, he/she does not have enough information, or … simply when, for some reason, the patient does not trust the people, centers or .. those who are treating him/her. (Market Study Head).

- To err is human. (Granada focal group). - There is no zero risk in Medicine. (…)Yes. There are always errors, but

that’s normal because we’re talking about large ones … staff, a lot of people and all the rest, and where there is a lot of personnel working, there are always human errors, right? (Galician Hemophilia Association).

No significant differences could be established in the discourse of patients having experienced an incident versus those who had not, those surveyed who had not experienced any incident themselves contributed cases from their close family and social environment, nor between patients with mild and severe disorders. On the other hand, it was indeed possible to note differences in the discourse of the patients and associations according to whether a chronic or an acute disorder was involved. In this regard, the patients with chronic disorders related the “patient safety” concept to a greater degree with aspects such as care continuity, accessibility to the professional, being treated like a human being and safety in drug prescription, whilst in the case of acute disorders or surgical interventions, incidents or mistakes were related more often. As specific cases, note is made of the situation of patients with allergies, above all, those allergic to latex, as specific needs with regard to safety in the hospital environment, as well as the case of Mental Health, with an interrelationship between health and psychosocial aspects.

- I think that in the case of a chronic disease, the priority is continuing care. (Granada focal group). What’s the first thing that pops into your mind when you hear the word “safety”? Guarantee, guaranteeing the providing of the service to citizens at all times based on criteria of quality. (Andalusian Service Professionals). It would have to be put in the Mental Health context. Patients have it very clear in their minds in other disciplines, but not is psychiatry. In psychiatry, there must be some safety criteria that are not being taken into account. For example, on the topic of suicide, the idea is posed that perhaps it is not being taken seriously or the health system is not aware of all those warning cases which end in suicide. This is a fault in the safety system… Safety


systems should be set out in all disciplines, even in those fields which are more sociosanitary. (FEAFES)

- What I would like is that when a medicine is prescribed, that those of us who are taking it be told. (Bilbao focal group). You’re talking to an association in which most of the patients have mobility problems, then they consider the prime safety problem in hospitals to be the possible architectural barriers there may be (Parkinson Galicia). There being no protocols for medical measures, the lack of coordination among health care levels, the sometimes highly limited degree to which the personnel who are providing you with care for highly specialized matters are trained make it impossible to talk about safety for patients without talking about Quality (Coalition of Citizens with Chronic Disorders). The first thing that pops into your head when you hear the word “safety”? Preventing errors and practices which lead to injuries or harm to the patients. Mistakes/errors due to malpractice. In the health system, there is a breakdown in the providing of care in all of the processes. In oncologists, this is very serious. From one physician to another, there are breakdowns. Nobody takes responsibility for following up on the complete process, if some undesirable or adverse effect occurs, everybody says that it’s not their responsibility… “It’s not my doing”. And it is impossible to know how it happened. There are professional repercussions, malpractice effects which nobody safeguards or prevents. The treatments leave many sequelae .. How many of them are due to errors? (Psychologist).

The representatives of patients’ and consumers’ associations stressed the importance of considering safety within the care-providing environment by relating the “patient safety” concept with organization and care quality aspects (coordination among levels of care, training of the professionals, information strategies, infrastructure, the existence of protocols).

- I identify safety with a quality meaning being free from danger, not causing harm or risk to health or to an individual’s physical or psychological integrity. (FACUA) When I hear the word Patient Safety, I find it to be a highly important subject, because there are mistakes and errors that harm patients and which can cost them their lives. It’s related to mistakes and to the need of preventing them. I think that the public at large is unaware of the importance of the subject. I also believe that many don’t want to know or don’t want to worry about this, given that, in general, patients don’t want to take responsibility for their disorders. They prefer “to put themselves in the physicians’ hands” and let the chips fall as they may. People have more confidence in the Associations than in the Health System for solving problems or consequences due


to a mistake or error. Errors and mistakes are human, but there should be guidelines for taking quality measures which all professionals should undertake and prevent them from improvising and making an error. People value being treated well, good outcomes, perhaps too much in their opinion. (In a restaurant, being treated well is a condition for even walking through the front door. In the health filed, being treated well is apparently a luxury. The topic of safety entails patients having to take an interest and get involved, and many are not willing to do so. It is easier to trust than doubt. Blind trust is easier. (CECU).

At the workshop held with association representatives, the phrase “patient safety” was related with the following aspects:• Lack of confidence = lack of information.• Lack of confidence = lack of being treated like a human being or lack of

humaneness. • Lack of confidence = feeling of “unprotectedness” in the Public Health

System, for the following reasons:• Lack of coordination among services and levels of care.• Lack of unified care-providing criteria.• No conveying of information from one professional or service to another

(it has to be the patients themselves who take on this role of “conveying information” on their medical history and the individual aspects of their case; whilst, when patients take on this role, physicians find it difficult to “admit not knowing”).

• Lack of follow-up on complaints.• No penalties in the event of mistakes.

Among the key agents and opinion leaders surveyed, different thoughts were found to exist concerning the patient safety concept.

A. From the Spanish Patients’ Forum perspective, patient safety is identified as a subject of potential social conflict, giving preference to the concept of “confidence” over the term “safety” (instead of perceiving vigilance regarding errors as a control of professional autonomy, the preference of conducting qualitative studies of the incidents is stressed). They believe patient safety to be an erroneous concept, mistranslated from the English language and therefore being of the opinion that all of the studies conducted on this subject within the Spanish scope (studies on the errors having occurred in the health system, at hospitals) are set out erroneously from the start, given that they point out that “in the English-speaking realm, “this type of studies/surveys are not done”. According to their opinion, it would be more suitable to conduct qualitative studies not by way of generic samples, but rather by way of clusters of problems, such


as on the subject of nosocomial infection or on medication in intensive care. They base themselves on the premise that patients place their trust in their physicians and in the health system, and it is true that there are errors, but according to their viewpoint, these errors are minor. In the event that they are major, other ways of remedying them must be sought. Within the concept of there being “minor” errors, they pose a “but”: being alert to possible cases, controlling, watching over the actions taken by the professionals. This vigilance cannot ever sound like fighting the system. Controlling errors must have more to do with confidence, confidentiality that with the current “patient safety” concept”. (Spanish Patients’ Forum).

B. The key agents interviewed within the scope of this research agree with this assessment of associating “safety” with “confidence”.

- To be truthful, when you mention the word safety to me, the term confidence immediately comes to mind, which I think happens because safety goes back to an objective fact of which patients cannot have a knowledge in actual terms, but rather that their greater or lesser feeling of safety is closely related to the confidence they have in the care-providing process, in the professionals,etc. (Market study manager).

C. From the perspective of representatives from the media field, information is identified as an aspect closely related to safety.

- They are lacking information. Being uninformed means a lack of confidence in the treatments being the most correct, more suitable ones. The key is better information so that there will be no lack of confidence. (Spanish National Radio & TV representative).

D. In the Mental Health field, it is suggested that the patient safety concept being related to care quality, confidence, respect and collaboration.

- This concept would have to be broadened to a more overall level. In psychiatry, a safety system must be the patients believing their team is the finest, that the building is safe … What this brings to my mind are words or concepts such as confidence, appreciation, respect, situations of trust … degrees of suggestion, proactive and collaborating attitude. Safety is everyone’s responsibility. (FEAFES).

Those interviewed also associate the “Patient Safety” concept with:1. Medicines: adequate information and informing on the contraindications

and side effects.


2. Treatments: adapting proper treatments; preventing mistakes in carrying out treatments; care continuity; information.

3. Allergies: specific needs of the group of patients allergic to latex such as the lack of protocols, hospital facilities and materials not being properly adapted (latex-free surgical theaters).

4. Professional experience. Training. Specific skills and experience. Calm, receptively willing to listen attitude.

5. Information on the disease, on the treatments, on the medication. Proper degree of information. Way of conveying the information.

6. Time management. Massification. Waiting times. Length of time of each office visit.

7. Care continuity/Intra-department and inter-level coordination. Care provided by the same physician. Avoiding contradictions in instructions and prescriptions. Conveying information among different levels and departments.

8. Protocols. Setting out protocols. Knowing the protocols set out.9. Surveillance and monitoring systems.10. Tangible aspects. Facilities. Architectural barriers.11. Physical and psychological safety.12. Reliability / Confidence.13. Social and cultural aspects. Immigrant population care. Bilingualism.14. Legal aspects. Use of the informed consent as a legal safeguard

mechanism. Medical professionals protecting their own.

Subjective experience of having had an adverse effectWhen asked about specific AEs, the patients relate a wide range of personal experiences. The most common have to do with errors in diagnosis and in surgical interventions, errors in medication, falls and accidents and infections. A specific concern was put forth by those allergic to latex concerning the safety and the preparation of the hospital environment in keeping with their needs.

Patients and representatives from associations vouch for the fact that “breakdowns in safety” do occur during hospitalization: the staff does not wash their hands between patients, lack of asepsis in handling catheters and tubing, in handling medication and food, very few measures for preventing falls, leaving the workplace dressed in work clothes, lack of coordination and communications among different professionals and departments, lack of homogeneity in implementing protocols, presence of unsupervised personnel possessing little experience, lack of time and overload among the professionals.

In many cases, the professional per se is not held to blame, the administration and health authorities being held responsible for the error on not providing the means necessary for preventing them: more professionals, more training, more protocols and more surveillance and monitoring systems.


In the case of people with chronic disorders, those surveyed stressed the fact that, for this group, safety was more closely related to the quality and continuity of the care provided than to preventing errors or incidents. However, after discussing this subject for a while, different cases of incidents and problems they or people in their close environment had experienced began coming to fore.

In their discourse, incidents were mentioned both in the surgical intervention process and in the prescribing and supplying of medicines. Above all, groups having specific needs, such as individuals allergic to latex, as well as people with chronic disorders in the case of admission to hospital unrelated to their disorder, reported adverse incidents. The unawareness of the professionals, the non-existence of care protocols or of proper facilities, as well as the lack of coordination among levels of care and specialties were identified as frequent causes of mistakes in hospital care.

A distinction can be made between the following types of incidents:• Incidents related to the prescribing and supply of medicines.• Incidents in the process of recognizing warning signs, diagnosis and

referral.• Incidents in surgical procedures.• Incidents in the childbirth process.• Incidents related to latex allergy.• Incidents in the blood transmission process.• Incidents related to hygiene aspects.• Incidents related to information aspects.• Incidents related to psychological aspects.• Incidents related to administrative aspects.

Current Status of the Patient Safety StrategiesGenerally speaking, the current measures are considered to be few in number, not well-coordinated and not agreed upon with the patients. This is why they are not identified as factors heightening the patients’ perception of safety. The representatives from different associations stress that patients with chronic disorders, as experts concerning their own disease process, possess a specific knowledge concerning their group’s safety-related needs, which, in their experience, often does not take into account the design of plans for action.

Different types patient safety-related measures currently in place were mentioned, the usefulness of each one thereof being assessed.

• ProtocolsThose surveyed mentioned that, in some areas, there are already safety-related protocols for taking action in place, whilst also having noted that


their implementation in practice is lessened due to the lack of knowledge as to their existence on the part of both the health care professionals as well as the patients. In turn, in specific areas such as the care provided for the needs of patients with allergies, a lack of protocols is noted, the remedying of the problems being left up to the patients themselves and their companions.

• Informed consentThe users surveyed mention the informed consent forms as a potential patient safety tool which is however perceived at present as a legal safeguard for the health care professionals.

• Surveillance systemsOne of the measures taken over recent years mentioned was the creation of surveillance and information systems, the usefulness of which is valued, whilst also pointing out the lack of citizen involvement in their design and implementation.

• Medical practice improvement measuresThe actions aimed at improving medical practice, such as the Ten Minute Platform or the safe medicine campaigns were mentioned as examples of measures related to Patient Safety, which are deemed to be more useful than further bolstering legal channels.

From the Mental Health field, mention was made of preventive measures, such as suicide prevention.

From the viewpoint of the Extremadura Ombudsman, Public Health Systems users find there to be an excessive degree of medical professionals protecting their own and of red tape, perceiving legal channels as the only strategy for prosecuting errors. The Ombudsman’s Office is described as an alternative way of filing complaints and settling incidents. Citizens feel “kept at bay”, alleging medical professionals protecting their own, cover-ups. The government functions with a great deal of red tape, with long, drawn-out, complex administrative procedures, citizen only feeling being protected to a certain degree, save in those places where Ombudsmen exist, through legal channels. The Ombudsman’s Office argues that it is necessary to seek alternatives for settling disputes.

• Measures not suitably adapted to the patients’ needs.At the workshop held with associations, it was stressed that, in some cases, measures are planned though the health services aimed at meeting demands expressed verbally by the associations, but which do not take into account the associations’ needs in their design and implementation, such as, for example, the demand for private rooms on the part of patients with long


hospital stays in critical situations or in the case of exitus. The association representatives surveyed mention how, at some hospitals, an attempt has been made to provide a response to this demand, but without taking into account the necessary measures for people with limited mobility.

Improvement-Oriented StrategiesThose surveyed suggested different improvement-oriented strategies with regard to patient safety-targeted measures.

• ProtocolsThe creation of specific protocols for the different clinical areas, as well as encouraging their being implemented, known and followed is considered to be an important strategy for heightening patient safety. For patients with allergies, this point is of particular importance. A greater homologation is also asked for in monitoring these care protocols so as to prevent unequal treatment in the health system, which can give rise to situations of lack of confidence. Some surveyed suggested the benefit of patients taking part in the design of the protocols and the associations in their dissemination.

• Creation of an error cultureFrom different areas, the importance is emphasized of creating an “error culture”, in the regard of a culture in which admitting error is possible and does not increase lack of confidence. The Spanish Patients’ Forum agrees as to their being a need for greater error control, whilst it is also of the opinion that more than talking about “errors” or “patient safety”, we should be talking about “confidence” and “confidentiality”. The person in charge of health care matters at the Ombudsman’s Office stated that the “error admitting culture” and “looking into the causes” is currently “as yet to be accomplished”.

- In Spain, it is impossible for physicians to say “I made a mistake”, not even politicians say that. They never admit having made a mistake. One example is the Leganés issue, and we’ll be seeing that in the court decision. They are not going to correct themselves. Harm is done and then nobody takes upon themselves even the possibility of having made a mistake. The media have to be included in this matter too. Another example is that of the politicians who make promises, do not keep them and then say they have kept them, like in the case of the waiting lists in Madrid. (…) It would be necessary for the error culture to be made well-known on a widespread basis, like the Zapatero thing and forms part of the culture. Physicians should admit errors. There is no reason why that has to give rise to any lack of confidence, but rather quite to


the contrary. The administrators would not agree to their physicians admitting errors, and then lists would be made. To err is human (… This subject should be widely publicized, not only through the Ministry but also through the Autonomous Communities, the health care community and the public and private clinics, given that this cannot be something which the public sector or the private clinics conceal for purposes of stock market listing (Spanish National Radio & TV representative).

- Error control has to have more to do with confidence and confidentiality that with the “patient safety” concept per se (Spanish Patients’ Forum).

- That not only errors due to erroneous treatment, erroneous organization or an erroneous diagnosis be taken into account, but sometimes errors due to an error on the part of the patient, errors in medication, this making the cases more complicated than when dealing with a medical error. That is why the cases have to be taken as cases per se, not as a vision of the system… they are cases. Put forth the subject of cases and the subject of transparency. (Catalunyan Patients’ Forum).

• Error Reporting.Regarding error reporting, different opinions were verbally stated. Whilst some of those surveyed are in favor of anonymous reporting, others point out the drawbacks involved, such as preventing individual taking of responsibility.

• Training of the professionals and carrying out a Patient Safety Plan at the center.From the User Assistance Services standpoint, it is proposed to promote training on the subject of safety for health care professionals, carrying out a specific patient safety plan and supporting professionals when an adverse event occurs.

• Improvement in Coordination.Especially in diseases such as cancer, in the care-providing process for which professionals from different specialties are involved, improving coordination is considered to be an aspect which is important for heightening safety.

• Care Continuity.The representatives from chronic patients’ associations emphasize the need for continuity in the care provided as a factor important to perceiving patient safety. In the case of mental disorders, they have asked for medium and long-stay centers to be created so as to prevent a break in care continuity in the changeover from an acute unit to home care.


• Multi-causal Disorder Care.In the case of multi-causal disorders, it is requested that multidisciplinary units be set up so as to prevent situations of lack of coordination and contradiction in the care by different professionals.

• User Assistance.A user assistance telephone number, with professionals trained in the specific needs of each disorder is another suggestion stated from the perspective of patients with chronic disorders.

• Roll of Unofficial Citizens.Especially in the case of chronic disorders, the importance of devolving professional duties to family members and non-professional caregivers is emphasized, given that this devolving of duties can give rise to unsafe situations.

• Complaints.From the standpoint of users’ and consumers’ organizations, it is suggested that the complaint process be expedited and be made more efficient, understanding the same not as a breakdown in confidence, but rather a “chance for improvement”.

• Tangible Aspects.It was suggested that associations and patients take part in the design of measures related to reducing architectural barriers so as to assure that they will be in keeping with the needs of patients with limited mobility and thus prevent situations entailing risks.

• Mediation, Harm Assessment and Quality Management Systems.From the perspective of the Ombudsman’s/ User Defense Officials Offices, it is suggested that systems for mediating and assessing harm/injuries be created. The Extremadura User Defense Ombudsman pointed out that these systems should not be focused solely on measuring adverse outcomes, but rather should include risk and quality management. The person in charge of health matters at the Ombudsman’s Office pointed out that alternative ways must be sought of settling disputes and of preventing resorting to legal channels and defensive medicine.

Alternative solutions for settling disputes must be sought: arbitration, negotiating agreements, … the Arbitration Law could bridge the gap. It would be necessary to design an alternative assessment system in the health care field, similar to the one for traffic accidents. That would be beneficial for the professionals, given that it would avoid lawsuits and negative opinions


among society, and also for citizens, as they would be getting redress for the injury/harm sustained.

• Citizen Information and Participation.Transparent information on the measures and citizen participation in carrying out the same are considered to be key elements of a patient safety policy. These aspects will be dealt with in greater detail in the following chapters.

Attitude Perceived Among the Health Care Staff in View of a Patient Suspecting an AEThe patients had perceived an attitude of denial or concealment among the professionals at the points in time at which the patients or their family members suspected, from their viewpoint, that an error or a practice entailing a risk might possibly have occurred.

They stated that it involved a major effort of their part to convey their doubts to the health care personnel and that the doubts put forth were not well received, having been taken in all cases as a lack of confidence and as the patients and/or their family members “meddling” in the professional’s work. As of that point in time, they perceived a defensive and “unfriendly” attitude on the part of the professionals.

The patients said that the fact of not admitting an error delays the possibility of minimizing or remedying the harm.

Measures Taken by the Health Care Professionals Following an AE: Patients’ PerceptionFirstly, an apology to the patient would be desirable. This is something not experienced by any of the persons surveyed. However, all find it important and would take it as a sign of respect and of wanting to remedy the potential problem. Those surveyed say the staff not admitting the error or apologizing gives rise to patients and family members wanting to take them to court.

The patients expressed their desire that, if an error occurs, it be admitted as soon as possible, an apology given and it be explained to the patient why it has occurred and that it be remedied as soon as possible.

In their assessment of the current situation as regard being informed as to possible health risks, those surveyed put forth different aspects they deem important:

• Importance of the Information.Being informed on rights related to the subject of safety is viewed as a prerequisite for participation.


- It is necessary to inform the patients of their rights, as to what it going to be done to them, how it is going to be done to them. Only this way can patients take part in their safety and in that of others (by preventing errors to others based on those they have experienced). The information on what they are going to do and as to how the process is viewed is important: who, when, how, what risks .. so that the patients can become involved and aid toward their safety (CECU).

- Patients should know more things, should have more information. One way is to share that information with the patients so as to cut down on errors this way, although it is true that they may not be too happy about it, but life moves ahead, and one has to encourage people to know progressively more and to share from both sides. It can’t be a relationship based on keeping one’s distance. (Spanish National Radio & TV representative).

- Citizens have to be provided with information enabling them to take action and make decisions, and the reason for the mistake or for the error must be explained to them. (Ombudsman’s Office – Health Manager).

• Too Little Information.The association representatives noted a lack of in-depth information on the part of the health care professionals, who sometimes recommend to the patients that “they go to the association for more information” (Association Workshop). The associations cover the “information void”, whilst also considering this not to be their role.

- In all of the cases with which we deal, there is a major underlying problem of lack of information (Ombudsman’s Office – Health Manager).

• Perceived lack of ability to communicate on the part of the health care professionals.According to the perspective of the users and association representatives surveyed, the proper conveying of information concerning potential risks is hindered due to a lack of communicating skills and a fear of legal repercussions noted in physicians. There not being enough time during the office visit is alleged as another reason for a lack of adequate information, as well as a fear on the part of the patients of demanding their rights.

- Communicating is the challenge facing physicians. They don’t know how, and it’s not because of not having enough time, it’s that I find a sense of humaneness to be lacking. That we are talking to people, that you are not begging off by saying you have 10 minutes. If necessary, you spend 20 minutes or you make the patient a side consultation.


Lately, what they are doing is referring them to the associations, and that’s something we know about. They tell the patients not to worry, you have such and such, and they will inform you at the associations. And they are attributing duties to the associations which are not theirs to perform. The latest diagnosis that they gave a twenty year old young lady, who came to the association in tears that same day and who was lucky to find us, because we calmed her down. That morning, they had given her the following diagnosis: you have multiple sclerosis. What’s that? Look, it’s a really shitty thing, in those words …. I’m sorry, because it’s gone onto the recoding … I recommend you go to the association and find out. And for your information, you’re not going to die WITH this, but you’re going to die FROM this. (Granada focal group).

- Physicians are really afraid … hematologists are really afraid. (…) Of the patients, because it is a really tough disorder to deal with, and sometimes they don’t want to come out on the losing end, or they get scared because a patient with a problem come in and might drop dead right there, having bled to death .. so, of course they are afraid. (Galician Hemophilia Association).

- Sometimes we citizens feel uncomfortable because they don’t explain to us what they are supposed to explain or should explain to us. One of the reasons is lifestyle … BEING IN A HURRY.. (FEAFES).

- If you save me, I couldn’t care less about what you do to me”. Cancer patients are passive patients who a totally trusting and who want, above all, to survive. (Psychologist).

• Perception of a Lack of Apologizing Attitude.In the event that an incident occurs, a lack of an attitude of admitting the error and apologizing is noted. In the opinion of the patients surveyed, an apology can revive confidence in the professional and heighten the perception of confidence, based on the thought “to err is human”.

- They must learn to apologize, although no consequences be involved. That three-month guarantee you get when you take your car to the repair shop is non-existent at a hospital. Apologizing, I think, would smooth one’s conscience. I’m human. I am so sorry. I have heard this one. They have only apologized to me after filing a complaint, and it was from a male nurse, the head nurse. After my talking to the director. Then he comes to apologize. It’s my fault. I’m sorry . and don’t you worry about … Then, I’m saying, that is apologizing, but forced. I think to err is human, but it would be very nice. But experience goes to show that .. in general, everyone should apologize. Political apologies come 140 years down the road (Granada focal group).


• The Roll of the Media.The media’s roll in broadcasting health risks is considered ambivalent. On one hand, the association representatives emphasize having been able to use the media for alert the public concerning health risks related to their disorder, whilst at the same time admitting that support is only provided when the issue is sensationalist. In turn, the creation of false expectations regarding treatments and medicines by way of less than clear or ambiguous news was criticized. From the perspective of the media professionals, unnecessary alarm being created among the population as well as a lack of self-regulation in the profession is denounced.

- False expectations … The problem is that the politicians give out this information, and it’s the same as when the subject arose of the famous health care check or the subject of home care … then there is no way of getting there … and I don’t know what people they would give it to, but I guarantee you that here it is a really tremendously minimal percentage, (…), but you are nevertheless hearing the politicians talk, and they are saying that it is all taken care of and that anyone can have this aid … when it’s not true (Parkinson Galicia).

- The media can have a calming or stirring influence, and one example is the thing in Leganés talking about Auschwitz or Dr. Mengele or Dr. Death, but one has to try to put some sensibility into the subject. There is no feeling as to whether you are alarming or frightening with some information, but rather that it is connected to the medium and to the way the medium is conceived. Hence, people speak out of unawareness, self-regulation therefore being hard … possible among the reporters, but not among the companies. And this is true, above all, in the written media, given that the editor-in-chief or copy editor fires up a piece of news by making up a headline that sets off a “war”. And one example are the talk shows featuring panels of guests. (Spanish Radio and Television representative).

The Patients’ and Associations’ Opinions and Expectations Concerning Their Participation in the Safety-Oriented StrategiesThose surveyed are convinced that with their help and collaboration, patient safety at hospitals would be greater and easier to monitor. They feel that patients must be actively involved. To this end, they find it absolutely essential to have more information on the techniques and treatments they are going to undergo, when and on the part of whom. They stated that it is urgent to improved informed consent and informing about the same, given that they are highly critical of the actual situation they have come to know regarding this subject.


They find the role of family members who take care of them during hospitalization to be highly important. They think their vigilant attitude can help a great deal toward preventing errors and guaranteeing maximum safety.

Some of those surveyed mention the importance of protocols for guaranteeing patient safety at medical centers. They point out that patients should take part in preparing these protocols, given that the experience of people who have been hospitalized is special for being able to identify the possible risks “invisible to the professional eye”.

Having been asked about the systems for reporting AEs, those surveyed took a position in favor of these systems and would like to be able to take part therein. Regarding whether or not reporting should be anonymous, opinions are divided although most are of the understanding that their being anonymous would facilitate reporting and therefore prevention.

As a result of all of the above, they find it absolutely essential that there be a change in attitude on the part of the professionals. They must consider patients as active subjects who want to take part in the decisions regarding their health and move away from defensive attitudes and denying errors or problems which may arise during hospitalization.

In reference to the associations’ role in remedying AEs, it was emphasized that, while patients at the individual level have very few possibilities of setting out complaints, the associations, on being able to combine several testimonies concerning frequent errors, can exert a greater amount of pressure. Mention was made of the lack of officially-organized spaces for participation, being confined to dialog with the Public Services and the filing of complaints and the use of pressuring strategies.

Despite having personally experienced or witnessed an AE episode in their own clinical processes or in their closest social environment, those surveyed in this study stress that, to their way of thinking, “safety” is not the same as “absence of errors” They name aspects such as confidence, communication, information, care continuity and psychological support as important factors for guaranteeing safety in the clinical realm. This concept of the term “clinical safety” moves away from an error concept-centered focus 5, 17, 19, 31-33, and from a definition of safety as “absence of accidental harm”47. Whilst it agrees with a more recent focus in published studies34-56 and current health policy5, 9, 11 which is based on tan idea of clinical safety as a synonym of communication, information, confidence and quality, risk management or “uncertainty management” 49. In this regard, it is pointed out that safety is not the same as an absence of risks49, and the relationship between quality and safety in the current health system is analyzed47, defining safety as “dignity and respect”51.

As have some authors4, 49, the patients surveyed base themselves on


the idea of it not being possible to prevent all errors, stating that “to err is human”. Instead of holding the particular professional, in whom they still have confidence, to blame, they stress the systemic nature of many errors, this being an assessment found earlier in the study To err is human4, and in different more recent works37, 49-52. Similarly, those surveyed point out the importance of changing over from a “blaming culture” which encourages error concealment, to a “culture of confidence” – a paradigmatic change recommended by different authors42, 49 and How-To Guides5, 8, 11. In this regard, the How-To Guide “7 steps to patient safety”9 created by the National Health Service names, among the seven steps outlined “build a safety culture”, “promote reporting”, “involve and communicate with patients and the public”. And the U.S. Agency for Healthcare Research and Quality recommends as one of the “30 safe practices” 5 creating a safety culture as well as facilitating the conveyance of information and communication. In the European realm, the Luxembourg Declaration11 points out the importance of information, participation and building a learning culture instead of a “culture of shame and blame”. In this regard, mention is made of a “safety culture”51, “responsibility culture”53 or “proactive culture”40.

When asked about specific incidents they had personally experienced or witnessed, those surveyed provided a detailed description of the situation having led up to the adverse event, as well as the approach for dealing with the same. They identified different preventive measure, such as better professional training, listening more for warning signs expressed verbally by patients, their participation in the clinical process, as well as the implementation of protocols for taking action, in keeping with the recommendations found in currently published sources5, 9, 11, 35, 42-44, 49, 54 which mention patients being informed and participating as an important factor in error prevention in the regard of creating a “competent patient” 54.

With regard to remedying incidents, the patients surveyed stress the importance of an apologetic attitude as an important factor - apart from remedying the harm – for continuing to have confidence in the professional, the need for which is also mentioned in other studies35, 43, 44. Unlike a U.S. study34 which states a high percentage of apologetic attitude among the professionals surveyed, the participants in this study say that the professionals neither admit their errors nor apologize.

As regards the currently-existing measures for preventing risks and minimizing harm, the clinical protocols and reporting systems are assessed as being positive, no consensus however having been reached as to whether anonymous or name-based reporting is preferred. In recently-published studies, different authors are found4, 6, 39, 55, 56 to have assessed and compared reporting systems, pointing out the value thereof, regardless of the model chosen, as a chance for improvement55, whilst also analyzing


potential reporting-related barriers37. In this regard, emphasis is placed on the importance of developing a “non-punitive environment”53 in the regard of a “responsibility culture”53 or a “proactive culture”40, and speaking of a paradigmatic changeover from reporting adverse events to “risk management”24. Those surveyed in this study point out the importance of the participation of the patients’ association in the process of implementing safety-related measures. In a study assessing the strategies for improving patient safety currently in place within the international realm, Otero26 finds it difficult to implement these strategies in current clinical practice.

Different authors35, 42-44, 49 identify communication as the key to patient safety, this being an assessment which agrees with those taking part in this study, who point out the importance of heightening the skills of the professionals in reporting adverse effects and their ability to listen for warning signs, as well as the importance of respecting the degree of information desired.

When asked about patient involvement in improving safety at different levels in their own clinical process through the associations and in the safety policies, the participants in this study criticize the very few possibilities for taking part beyond complaint and revindication strategies. In both recently-published studies 30, 35, 40, 41, 43, 44 and in How-To Guides published by public health administrations5, 9, 11, 14, greater citizen participation in safety policies and risk management is recommended with the objective of improving the suitable adapting of the measures to the citizens’ needs. According to Vincent44, patients are not “passive victims” of adverse effects, emphasizing the prospects for participation in the diagnosis and treatment process. Liang43 points out the importance of the patient’s active involvement in the incident-solving process under the system’s aid in the regard of psychological support and offer of mediation so as to avoid legal proceedings. Davis, Jackin, Sevdalis and Vincent30 identify different potential barriers to patient participation; patient-related aspects (i.e. sociodemographic characteristics), related to their disorder, related to the professionals’ knowledge and beliefs or to organizational aspects.


3. Patients for Safety in the National Health System Declaration and Commitment

Born out of this process is the following Declaration, to which 19 patients and consumers associations adhered and which was made public at the III International Patient Safety Conference held in Madrid on December 13-14, 2007:

For us, citizens and patients who need the health services and the professionals thereof to keep and recover our health or improve our quality of life, SAFETY in health care is a fundamental element and also a basic RIGHT in which we wish to become involved in order to aid toward the maximum development thereof.

For us, safety in the care and confidence in the professionals who provide care for us is of major significance for us, citizens and patients, given that this has a bearing on the assessment we make of the care provided and of the health system in Spain as a whole.

We recognize the efforts that are being made nationwide and internationally to improve Patient Safety.

We want to collaborate with authorities, politicians, social representatives, NGOs, associations, scientific societies, health care professionals and with all those organization and individuals who are working for Patient Safety.

We demand that Patient Safety be a priority in all National Health System the policies and actions.

We demand maximum SAFETY ASSURANCES in all health care settings: • assurances that possible adverse effects will be prevented • assurances that effective means exist to report any adverse events that

may occur • assurances that we receive care in a clean and safe environment, free of

elements that may cause adverse effects to us or to other persons• assurances that we are offered the best possible treatments based on

scientific evidence and on the existing protocols • assurances the we receive proper, continuous advice • assurances that we are provided with clear, sufficient information • assurances that we are listened to and our opinion taken into account and


our involvement facilitated • assurances that the individuals working there are concerned about and

take an interest in our health and overall well-being.

We UNDERTAKE to become actively involved in: • Participating in the design, implementation and evaluation of the programs

aimed at improving the Safety of citizens and patients in all health care settings.

• Collaborating in defining good clinical practices and in their implementation in all health care settings.

• Reporting the incidents subject to affecting our Safety, under the commitment and responsibility for improving.

• Informing citizens, patients and family members in general as to how they can contribute to preventing adverse effects and minimizing the possible risks for their health.

• Receiving training and training others so that they can play a more active role in the relations with the health care professionals and services, facilitating their participation in the decisions affecting their health, understanding this to be a valuable mechanism for improving their Safety.

• Participating in specific patient safety-oriented bodies• And maintaining an attitude of collaboration, dialogue, respect and

confidence with all individuals and institutions desiring and working for Patient Safety in health care.

Anyone’s health and life will benefit from the efforts being made for Patient Safety.

And to guarantee and achieve safety in the health care provided to us and our confidence in the National Health System, we ask COMMITMENT, HONESTY, TRANSPARENCY AND PARTICIPATION.

And we offer COMMITMENT, HONESTY, TRANSPARENCY AND PARTICIPATION.


4. Menorca Conference at the Public Health Summer School, Start-up of the Citizen Trainers Network.

Objectives • To carry out activities for the patients associations interest in disseminating

patient safety (clinical safety, medicine-related safety, office visit communications for improving safety, attentive listening and specific empathy).

• Create a network of patients training patients for patient safety.• Evaluate the contents development by the network of patient trainers in

patient safety and improve the activities carried out concerning patient safety.

Panel Discussion OutcomesObjective

• Identify materials which should be in the virtual classroom of the patient trainers for patient safety.

MethodologyA panel technique was carried out in several phases:

1. Gathering ideas with cards on the part of each one of those responsible for associations who were taking part in the meeting.

2. Explanation of the resulting ideas.3. Unification of the resulting ideas.

Basic aspects of the presentations concerning:A. Clinical safety.B. Teaching methodology.C. Communicating with patients.D. Informed consent.


1. Patient rights and obligations Know the patient rights and obligations, access to medical record, legal framework, access to information, etc.

2. Information by disorders Minimum guides for each disorder

3. Communication Improve the communicating skills of profes-sionals and patients

4. Active patients /Association as a key element / Patient participation / Opinion leaders

5. Information prior to surgi-cal interventions / Reading and understanding the informed consent form / legal issues

6. Medication The hospital pharmacist’s role, reading and understanding medication package inserts, etc.

7. Caregivers/family/reconciliation of wor-king and family life

TRAINING

8. Prevention and self-care

9. Specific groups Elderly, children, caregivers

10. Information to companies /patients as-sociations / volunteers /corporate social responsibility

A. Clinical SafetyFollowing an analysis of the problem and the perception thereof, the

principles for safety were set out based on the three “H’s”:• HUMBLENESS, toward ourselves.• HONORABILTY, toward the Citizens.• HONESTY, toward Science and Society.

And with this, we moved from the basic concepts to the ideas, for a comprehensive taxonomy:• Adverse Effect (related to health care).

Classification: a) Preventable. b) Repercussion / seriousness.

• Accident. Versus incident.• Near errors.• Medical error. Mistake or oversight.


• Medication error.• Adverse reaction to medication.• Negligente.• Malpractice.• Litigation.

And then on to defining the primary categories of adverse effects.Based on all of the above, it can be concluded that:

• We cannot change the human condition, but we can change the conditions on which human actions are based.

• We are dealing with a health system in which care is provided such that confidence is created not only in those providing the care but rather that those receiving the care fully trust in the quality of the care provided.

• The patients and organizations have a commitment of making quality not being possible without safety a reality.

B. Teaching MethodologyBased on one principle: reciprocity as the basis for good communication

between those teaching and those learning.Percentage of data retained by the students

• From what they read… 10%• From what they hear… 20%• From what they see… 30%• From what they see and hear… 50%• From what is said and discussed… 70%• From what is said and put into practice… 90%

Training Method:speak + ask + think + write down + do + make it a practice

Better than:Trainers: talks and students: listen

Training method:• Learning through experiences.• Contributing their experience to the learning process.• Having feedback concerning their learning.

For preparing a training session, it is important to take into account …THE BEFORE: the preparation and THE AFTER: the closing, in addition to THE DURING: carrying out the session.


• Keys to communication: skills necessary for carrying out a training session: A. The fullest possible knowledge of the listening audience.B. The preparation of the contents, the environment and the objectives.C. Carrying out the methodology, the arguments and possible objections.D. The techniques employed in the process.E. Questions and answers.F. Closing.

C. Communicating with patientsBased on 3 principles: • The patient as a necessary collaborator. • Informed patient – second control. • Facilitating the patient taking part in the clinical decisions heightens the

patient’s clinical safety (and the professional’s legal security).

80

60

40

20

0

Explain treatment effectsand precautions

40

72,4

44,7

72,1

41,7

67,2

Explain diag. tests Have been able to askquestions to clear up doubts

Reports AE Does not report AE

Lastly, examples of campaigns for getting patients actively involved in clinical safety were analyzed and recommendations for patients were set out:• Make certain of the date and time of the office appointment.• Be on time for the appointment (calculate how long you need to get to

the office).• If you don’t mind, ask someone in your family or someone close to you to

go with you.• Write down ALL the medicines you are taking and the dosage you are

taking of each one.• Inform your physician if you are regularly taking diet supplements, herbal

teas or other remedies or other medicines which you have purchases at the pharmacy even though no prescription is required.


• Take the specialist’s report and the results of the latest analyses or tests with you.

• Listen attentively to your physician and ask questions about anything which is not clear to you. Make certain that you fully understand how to take the medication your physician has prescribed for you.

• Although you can read some information on the Internet, your physician is the one who knows more about your disorder. Be careful and distinguish between what is updated information and what is advertising.

D. Informed ConsentBased on the principle of Santiago Ramón y Cajal (1852-1934) Nobel Laureate in Physiology and Medicine, 1906.

“The worst part is not in making a mistake, but in trying to justify it instead of using it as a heaven-sent warning of our mindlessness or our ignorance.”

After reinforcing the taxonomy and conceptualizing and repeating the adverse effect (preventable and unpreventable) concept, adverse event and adverse incident and complication, the patients for patient safety declaration was discussed to then delve into the legal topic of patient rights:

Article 2. Basic Principles.1. The dignity of a human being, the respect of the independence of the

wishes thereof and of the privacy thereof shall guide all activities aimed at obtaining, using, filing, keeping and conveying the clinical documentation and information.

2. Any measure within the scope of health care generally requires the prior consent of the patients or users. This consent, which must be obtained after the patient has been furnished with adequate information, shall be rendered in writing in the cases for which provision is made under law.

3. Patients or users are entitle d to freely decide among the available clinical options after being furnished with the adequate information.

4. All patients or users are entitled to refuse treatment, except in the cases stipulated under law. The refusal of the treatment must be stated in writing.

5. Patients or users are under the obligation of furnishing the data on their physical condition and on their health faithfully and truthfully as well as of collaborating in their data being taken, especially when they are necessary for reasons of public interest or for providing health care.

6. All professionals involved in the care-providing activity are under the obligation not only of correctly performing their techniques, but also of fulfilling the duties of informing and clinical documentation and respect for the decisions freely and voluntarily made by the patients.


7. The person who prepares or has access to the clinical documentation or information is under the obligation of safeguarding due confidentiality.

8. Prior to asking the patient to render his/her informed consent, the physician shall provide the patient with the following basic information:

a) The relevant or major consequences to which the intervention safely gives rise.

b) The risks associated with the patient’s personal or professional circumstances.

c) The probable risks under normal conditions, according to the experience and the current state of science or directly related to the type of intervention in question.

d) The contraindications.9. The responsible physician must weigh in each case that the more uncertain

the outcome of an intervention, the more necessary the patient’s prior informed consent in writing is.

Lastly, the informed consent form was discussed and debated, it having been concluded that the informed consent form is not only a legal “defense” tool, but also a patient right.

Workshop ConclusionsA. Concerning the basic principles of safety• We cannot change the human condition, but we can change the conditions

on which human actions are based.• We are dealing with a health system in which care is provided such that

confidence is created not only in those providing the care but rather that those receiving the care fully trust in the quality of the care provided.

• The patients and organizations have a commitment of making quality not being possible without safety a reality.

B. The following is necessary for a good presentation:1. The fullest possible knowledge of the listening audience.2. The preparation of the contents, the environment and the objectives.3. Carrying out the methodology, the arguments and possible objections.4. The techniques employed in the process.5. Questions and answers.6. Closing.

C. Concerning the PANELBased on the first brainstorming session at which a total of 30 ideas

were identified, these 30 ideas were grouped into 10 major topics to be developed on the part of the citizen network of patient safety trainers.


The 10 major topics are:1. PATIENT RIGHTS AND OBLIGATIONS. 2. INFORMATION BY DISORDERS. 3. Improvement in the communicating skills of professionals and patients.4. Encouraging PATIENTS to be ACTIVE, that there be PATIENT

PARTICIPATION and that the ASSOCIATIONS BE A KEY ELEMENT and become OPINION LEADERS.

5. INFORMATION PRIOR TO SURGICAL INTERVENTIONS. READING AND UNDERSTANDING THE INFORMED CONSENT FORM.

6. Reading and understanding medication package inserts.Improving the degree to which patients are informed and trained

by creating a network of patient trainers in patient safety can aid toward patients feeling they are necessary collaborators, playing an active role and aiding toward improving patient safety.

D. Concerning communicating with patients• Talking about clinical errors is not easy due to the emotional, economic,

social, professional and legal consequences involved. But not talking about them is irresponsible.

• Don’t be left wondering. Ask your physician.


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6. Annexes

Annex I. Focal Group and Personal Survey Scripts

Focal Group ScriptPatients not having experienced any incident

1. Presentation (5 minutes).

2. Round of opinions (15 minutes).• What is the very first thing that pops into your mind when you hear the

word “patient safety”?• “What doubts come to mind when you hear someone mention safety in

the health care setting? Can you think of anything in particular that you find to be cause for concern?

• What do the phrases “a safe hospital” or “a safe medical center” mean to you? Do you think hospitals are safe? And Medical Centers? (in what aspects are they safe, in what aspects are they not).

3. Specific cases (40 minutes).• Think of a possible incident in the course of your contact with the health

system (make a list of examples).• Now we are going to ask you to please complete this card, choosing one of

the possible cases: (write individually, reach consensus).Questions on card:• What strategies would you like to see used to try to remedy this incident?.• What do you expect of the health authorities in remedying this incident?• And of the professionals?• What rights do you think you have?Question for discussion:• Do you think that the strategies should differ depending on whether or not

an incident has consequences on health? We think of physical consequences and also non-physical (emotional and psychological) consequences.

3. Communicating (10 minutes).• Would like your physician to discuss safety-related matters with you on your

office visit?• How do you think possible risks could be reported without causing alarm

or lack of confidence? Through which channels?


4. Errors (15 minutes).• How often have you read or heard something related to errors in the

health care setting?• How important do you find the subject of errors in the health care setting

in our country to be?• To what degree are you confident that health care professionals will not

make mistakes which may affect you? (Think of physicians, nursing staff, primary care physicians).

• Has anyone in your family experienced a major error in a hospital or due to a medication having been erroneously prescribed by a physician?

• In your opinion, what do you think the likelihood is of a patient experiencing a major error at a Hospital?

• And of a patient being able to prevent it?• In general, how concerned are you about experiencing an error?• And, in your opinion, how concerned should patients be about possible

errors?

5. Participation (15 minutes).• Do you think that there are currently ways in which patients can take part

in improving patient safety? In what ways can they do so?• Do you find them accessible? And effective?• What other ways can you think of?• What do you think the role of the associations could be regarding patient

safety?• How do you think that spaces shared between professionals and citizens

could be created to deal with safety-related matters?

6. Is there any other aspect you would like to mention? (5-10 minutes)


Focal Group ScriptPatients having experienced an incident

1. Presentation (5 minutes).

2. Round of opinions (15 minutes).• What is the very first thing that pops into your mind when you hear the

word “patient safety”?• “What doubts come to mind when you hear someone mention safety in

the health care setting? Can you think of anything in particular that you find to be cause for concern?

• What do the phrases “a safe hospital” or “a safe medical center” mean to you? Do you think hospitals are safe? And Medical Centers? (in what aspects are they safe, in what aspects are they not).

3. Specific cases (40 minutes).• Think of a specific incident you have experienced in the course of your

contact with the health system. We would like for you to tell us what the incident was, how it was remedies, whether or not there were any consequences and, if so, what type (make list of examples).

• Now we are going to ask you to please complete the following card, thinking about the case that each one has mentioned (write individually, reach a consensus):

Questions on the card:• What was your opinion of the strategy used to remedy the incident?

• What strategies would you like to see used?• What do you expect of the health authorities in remedying this incident?• And of the professionals?• What rights do you think you have as patients?Question for discussion:• Do you think that the strategies should differ depending on whether or not

an incident has consequences on health? We think of physical consequences and also non-physical (emotional and psychological) consequences.

3. Communicating (10 minutes).• Would like your physician to discuss safety-related matters with you on

your office visit?• How do you think possible risks could be reported without causing alarm

or lack of confidence? Through which channels?


4. Errors (20 minutes).• How often have you read or heard something related to errors in the

health care setting?• How important do you find the subject of errors in the health care setting

in our country to be?• To what degree are you confident that health care professionals will not make

mistakes which may affect you? (Think of physicians, nursing staff, primary care physicians).

• Has anyone in your family experienced a major error in a hospital or due to a medication having been erroneously prescribed by a physician?

• In your opinion, what do you think the likelihood is of a patient experiencing a major error at a Hospital?

• And of a patient being able to prevent it?• In general, how concerned are you about experiencing an error?• And, in your opinion, how concerned should patients be about possible

errors?

5. Participation (15 minutes).• Do you think that there are currently ways in which patients can take part

in improving patient safety? In what ways can they do so?• Do you find them accessible? And effective?• What other ways can you think of?• What do you think the role of the associations could be regarding patient

safety?How do you think that spaces shared between professionals and

citizens could be created to deal with safety-related matters?

6. Is there any other aspect you would like to mention? (5-10 minutes)


Survey Script(Associations)

1. What is the very first thing that pops into your head when you hear the word “safety”? What would you say “patient safety” is?

2. Do you know of any safety-related measure that is currently carried out in the health care setting?

3. Thinking of patient safety-oriented measures, what aspects would you like to be taken into account? (examples: reviewing the medication before taking it, noticing that the physician cleanses his/her hands between office visits).

4. In the event of noticing some incident during the course of your contact with the health system, in your opinion, what is currently the most effective way of getting it remedied and preventing it from occurring again. What other ways can you think of?

5. Would you like to be advised of possible risks, or would you rather not know about them beforehand?

6. If you would like to be advised, how would you like to be informed?

7. When you hear the subject of safety in the health care setting mentioned, what does that make you think? Does it put your mind at ease because you think work is being done on it or, to the contrary, does it give you a feeling of uncertainty?

8. Do you think that there are currently ways in which patients can take part in improving patient safety? In what ways can they do so? Do you find them effective? What other ways can you think of?

9. Is there any other aspect you would like to mention?


Survey Script(Market Study Representatives)





5. Regarding possible risks, to what extent do you think it is advisable for users to be informed?

6. From your point of view, what would be the best strategy for informing the population concerning possible risks / safety-related aspects?




Survey Script(Public Health System Ombudsman)

1. What percentage of the citizen complaints received by the Extremadura Public Health System Ombudsman would you say have to with Patient Safety-related matters?

2. Could you describe some specific examples for us?

3. As regards Patient Safety, what would the main subjects into which citizen complaints received by the Public Health System Ombudsman be grouped?

4. What are the main causes giving rise to the Patient Ombudsman stepping in?

5. What is your opinion regarding alternative ways of settling conflicts (arbitration, mediation, injury assessment, etc.)

6. What response has the citizen usually received from the Government Services and/or the medical centers in view of the Patient Safety-related problem prior to taking recourse to the Public Health System Ombudman’s Office?

7. What response is the citizen given from the Public Health System Ombudsman’s Office?

8. Within this framework, taking into account your experience, what elements do you think should be considered when preparing policies, plans, strategies for improvement, etc. of Patient Safety in health care settings?

9. Lastly, what is your opinion regarding the possibility of patients taking part in preparing these Patient Safety-related strategies? In what way?


Survey Script(Key User Assistance Service Professionals)


2. Could you tell us about some specific experience from your field of work related to the subject of safety / incidents? Can you tell us how it was remedied? Do you think it was remedied properly or that it could have been remedied some other way?

3. Thinking of patient safety-oriented measures, what aspects would you like to be taken into account?

4. Regarding possible risks, to what extent do you think it advisable that users be informed?

5. From your point of view, what would the best strategy be for informing the population concerning possible risks?




Survey Script(Media)





5. Regarding possible risks, to what extent do you think it is advisable for users to be informed?

6. From your point of view, what would be the best strategy for informing the population concerning possible risks / safety-related aspects?

7. What role do you think the media can play? Can you think of any specific action which could be useful?

8. Could an advertising campaign on the subject of patient safety be effective. If so, what ideas come to mind?


10. Do you think that the tools which could be given to patients to heighten safety (such as providing questions they could ask their physician of the type “Have you washed your hands?) might help toward heightening confidence or that, to the contrary, they would cause alarm?



Association Workshop Script

9:30Introduction of the workshop and of the participants.

10:00Working groups.(Sub-groups of 8 individuals, moderators gathering information using

cards).All of the working groups:In your experience as an ASSOCIATIONSelect one incident of those which someone from your Association has

experienced in the course of their contact with the public health system and try to answer the following questions:• What strategies were used to try to remedy the incident?• What agents were involved?• Could you assess the usefulness of these strategies?• Can you think of other ways or remedying this incident?• What role did the Association play in this strategy? Do you find it suitable?

If not, what do you think an Association’s functions could be in these strategies?

In addition to the above, each group focuses on one specific topic:Group 1From your experience as an ASSOCIATION - If you think of patient safety-oriented measures

• Current measures.• Opinions regarding their usefulness.• Aspects for improvement.• Suggestions of other measures.

Group 2From your experience as an ASSOCIATION - Your opinion regarding the prospects for Associations being involved

in improving patient safety• Current participation mechanisms.• Opinions regarding their usefulness.• Aspects for improvement.• Suggestions of other mechanisms.

Group 3From your experience as an ASSOCIATION

• If we think of information strategies concerning possible health risks.• In your experience, how are the associations currently being informed as

to possible health risks?


• How would you assess these current ways of informing you?• How do you think information could be provided concerning health risks

without causing alarm or uncertainty?

11:00Coffee break

11:30Preparation of conclusions by sub-groups.

12:00General meeting.

• Explanation of the working group results (by their moderator).

12:30General meeting.

• Open debate.From your experience in the Association realm:

• What do you consider to be the most important aspects of “patient safety”?• What aspects are those which should be improved the most?• What suggestions for improvement do you have?• Do you consider Medical Centers to be safe?

• Conclusions

13:00Lecture by ALBERT JOVELL.

14:30End of workshop and refreshments.


Annex II. Informed ConsentGood morning / afternoon...

You have been selected to take part in this study, because we believe you can be of help to us, as your participation is especially important for achieving the purpose of our study.

You are going to be taking part in an audit which, at the request of the Ministry of Health and Social Policy Quality Agency, aims to ascertain the needs, opinions and expectations of patients, associations and citizens regarding Patient Safety in the National Health System.

The conversation will be recorded, and the data will be analyzed by the members of the Andalusian Public Health School team.

We assure you that your opinions and assessment will be kept confidential, and we shall use or publish the information you provide, but not your name.

If you so desire, you may request a report including the study findings. For any further information or queries, please call (researcher’s name) at (researcher’s telephone number).

I consent to taking part in the study.“Expectations and position of patients, associations and citizen

concerning Patient Safety in the National Health System”.

The patient (full name)

(Patient’s signature)

THANK YOU VERY MUCH FOR YOUR COLLABORATION

www.mspsi.es

GOBIERNODE ESPAÑA

MINISTERIO DE SANIDAD, POLÍTICA SOCIALE IGUALDAD

The Strategy number 8 of the National Health System Quality Plan includes patient safety as one of the key elements to improve the quality of health care. One of the specific objetives of this strategy is to encourage active patient involvement in patient safety policies by jointly developing with its associations collaborating models and training activities. This line of action is in keeping with the WHO Patient Safety Program recommendations, which specifically sets out the “patients for patient safety” as one of its six strategic programmes.

In this regard, the Ministry of Health, Social Policy and Equity through the Quality Agency for the National Health System has gotten a number of projects under way for ascertaining the perceived experience of patients and consumers concerning patient safety and setting up participation mechanisms.

This report includes the description of the analysis of possible problems from the patient, consumer and expert group perspective regarding patient safety, as well as intervention strategies within this scope.

http://www.mspsi.es

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