Manuale EiR - Clinica Hildebrand - english version

 

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Manuale EiR - Clinica Hildebrand - english version

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EXCELLENCE IN REHABILITATION (EiR) International accreditation standards of excellence for Rehabilitation Centres 2nd Edition, MARCH 2015

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Excellence in Rehabilitation (EiR) Second edition, Effective1 March 2015 © 2015 REHA TICINO All rights reserved. No part of this publication may be translated or reproduced in any form or by any means without written permission from REHA TICINO - www.rehaticino.ch - info@rehaticino.ch Should you have any questions about the accreditation process, please contact Bureau Veritas Italia SpA – info.certification@it.bureauveritas.com – www.bureauveritas.it

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Contents Contents Panel of experts who participated in developing the standards ....................................................... 7 Foreword ........................................................................................................................................ 9 I. Purpose ................................................................................................................................... 11 II. Scope ..................................................................................................................................... 11 SECTION 1. .................................................................................................................................. 13 1. 2. 3. 4. 5. 6. GOVERNANCE AND LEADERSHIP ACCOUNTABILITIES .................................................. 14 QUALIFIED AND COMPETENT STAFF ............................................................................... 16 WORK ENVIRONMENT AND FACILITY SAFETY ................................................................ 20 DIAGNOSIS, TREATMENT AND PATIENT CARE PROCESS ............................................. 23 DOCUMENT MANAGEMENT SYSTEM................................................................................ 29 PATIENT SAFETY AND CONTINUOUS QUALITY IMPROVEMENT .................................... 32 SECTION 2. .................................................................................................................................. 35 Chapter A: NEUROLOGICAL REHABILITATION ........................................................................................ 36 Governance and Leadership accountabilities ......................................................................................... 36 Qualified and competent staff ................................................................................................................. 36 Work environment and facility safety ...................................................................................................... 36 Diagnosis, treatment and patient care process ...................................................................................... 37 Chapter B: MUSCULOSKELETAL REHABILITATION ................................................................................ 39 Governance and Leadership accountabilities ......................................................................................... 39 Qualified and competent staff ................................................................................................................. 39 Work environment and facility safety ...................................................................................................... 39 Diagnosis, treatment and patient care process ...................................................................................... 40 Chapter C: CARDIOVASCULAR REHABILITATION ................................................................................... 41 Governance and Leadership accountabilities ......................................................................................... 41 Qualified and competent staff ................................................................................................................. 41 Work environment and facility safety ...................................................................................................... 42 Diagnosis, treatment and patient care process ...................................................................................... 42 Chapter D: PULMONARY REHABILITATION............................................................................................... 44 Governance and Leadership accountabilities ......................................................................................... 44 Qualified and competent staff ................................................................................................................. 44 Work environment and facility safety ...................................................................................................... 45 Diagnosis, treatment and patient care process ...................................................................................... 45 III. Abbreviations ......................................................................................................................... 47 IV. References ............................................................................................................................ 48 © 2015 REHA TICINO

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Panel of Experts Panel of experts who participated in developing the standards (in alphabetical order): Iginio Bassi, director of nursing, Clinica Hildebrand Centro di riabilitazione Brissago (CRB) Fabio Mario Conti, MD, neurologist, former CRB medical director and SW!SS REHA chairman Daria Dinacci, MD, neurologist, senior physician, CRB Chantal Fasoletti, chief physician of the neuropsychology and speech therapy unit, CRB Professor Alessandro Giustini, MD, scientific director, Ospedale Riabilitativo San Pancrazio Arco (Trento, Italy) - Gruppo Santo Stefano. Former president of the European Society of Rehabilitation Medicine, and chair of the ISPRM (International Society of Physical and Rehabilitation Medicine) WHO Liaison Committee on the Implementation of WHO's World Report on Disability Angela Greco, MS, head of quality and patient safety, REHA TICINO and Ospedale Regionale di Locarno. She is one of the project managers for the creation of the EiR accreditation model. She was responsible for editing and publishing this standards manual Carlo Magelli, MD, cardiologist and medical radiologist, lead auditor and medical director, Bureau Veritas Italia. He participated in the development of the 1st edition of the EiR standards manual Andrea Marforio, chief physician of the physical therapy and occupational therapy unit, CRB, and member of the Executive Board of REHA TICINO Giovanni Rabito, quality manager, quality and patient safety service, REHA TICINO and Ospedale Regionale di Locarno Gianni Roberto Rossi, CRB Chief Executive Officer and chairman of the Executive Board of REHA TICINO. He is one of the project managers for the creation of the EiR accreditation model Paolo Rossi, MD, neurologist, assistant medical director, CRB Graziano Ruggieri, MD, geriatrician and rehabilitation physician, CRB medical director and member of the Executive Board of REHA TICINO Fabio Sartori, MD, cardiologist, head of service, Ospedale Regionale di Bellinzona e Valli, and member of the Executive Board of REHA TICINO Antonio Satta, MD, pulmonologist, consultant for Ente Ospedaliero Cantonale – hospital sites: Ospedale Regionale di Lugano, Ospedale Regionale di Locarno, and Ospedale Regionale di Mendrisio Nicola Schiavone, MD, physiatrist, medical director and chief medical officer, Clinica di riabilitazione di Novaggio, member of the Executive Board of REHA TICINO Francesca Vassallo, business developer and healthcare auditor, Bureau Veritas Italia We also thank all REHA TICINO Board members; Adriana Degiorgi, head of quality and patient safety, EOC; Massimo Dutto, director, healthcare department, Bureau Veritas Italia (BV), and BV project manager for the creation of the accreditation model; Vincenzo Iaconianni, president, Exem consulting SA, for their participation in the project. © 2015 REHA TICINO 7

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Foreword Foreword The last few years have been witnessing a very broad and profound change that is sweeping through the field of Rehabilitation and transforming its cultural, organizational, patient care, and scientific foundations. This change is underscored by a growing and conscious linkage between typically medical and healthcare issues, that are at the core of change, and the social welfare and global issues of community life, that we could also refer to as political-ethical, financial, and cultural issues. This change is taking place basically across all European countries, as well as in many other contexts that cannot be defined under the traditional term of “advanced”; on the contrary, Rehabilitation shows development in many other countries, that often precedes and drives the development of the healthcare and social welfare system as a whole. Health had always been – rightly – defined by WHO as a complex mix of personal and environmental factors and conditions well beyond the mere lack of illness. We do however know how this was not part of the common feeling of the population, nor was it part of the operating modalities of healthcare systems. It was always the "illness", its denomination and care, to dominate. Today the situation is changing deeply because people are increasingly evaluating the quality of their own life that they want to spend with or without illness for the longest possible time and with the best possible physical and intellectual independence. On the other hand, the efficacy of medicine and technology, that succeed in keeping large numbers of individuals alive with chronic conditions, with the sequelae of these conditions or even of the severest of traumas, is resulting in a growing demand for Rehabilitation services. The current trend is very positive and acknowledges many other co-factors, including economic factors. To put it very short, we can track its origin to the UN-WHO guidelines following the Convention on the Rights of Persons with Disabilities and, in Europe, to several position papers on these issues released by the European Parliament and other EU bodies. In particular, thanks to the International Classification of Functioning, Disability and Health (ICF), this change has started to have logic and strategy. ICF has provided a completely innovative paradigm to analyze and describe the different needs and potential of the Person – seen both individually and in the interrelation with every dimension of the context in which the Person lives – in relation to Health. And Disability has progressively been accepted and recognized as a life condition for each and every individual (whether it be temporary or permanent, major or minor) in relation to the different stories of Health, to the living environment, to individual strengths. Another co-factor for this profound and rapid change is undoubtedly the large evidence of research results in basic sciences and clinical practice, as well as in the areas of management and organization, in the field of Rehabilitation Medicine and of its instruments to oppose every situation of Disability. These data have led to attaining major breakthroughs in the processes for patient assessment and rehabilitation management, providing increasingly better responses to the expectations stemming from the rights of Persons with Disabilities. Expectations and Rights thus meet with interventions, at the same time also – and rightly – generating a very strong demand for the efficiency, appropriateness and review of behaviours, competences, and outcomes. Today Rehabilitation Medicine has thus overcome the minimalist vision associated with fragmented interventions and with the listing of rehabilitation services, and has come to a complex, organic, multidisciplinary, and scientifically sound approach, fit for the ethical and social role it is called upon to play. Those greater and greater expectations, those more and more informed rights, and – last but not least – the financial value of interventions all demand a system of absolute safety, controls, and transparency. Under this perspective, it is essential to review the features of the facilities where rehabilitation is managed, where the necessary competences are based and developed. And this in © 2015 REHA TICINO 9

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Excellence in Rehabilitation (EiR) terms of the facilities in the strict sense of the word, and in terms of procedures, staffing, operational and technological resources. Thus, there is a clear need for, and today also the possibility of, improving overall the definition and visibility of interventions during hospitalization in rehabilitation centres, monitoring the interventions carried out, their consistency and continuity, as well as their safety and outcomes. This is as important a duty towards patients and the Community as the duty to ensure the ongoing competences and current scientific learning of us all. We know how patient management in Rehabilitation Medicine is particularly complex and multifaceted, how it means dealing with stratified case mixes including extremely different patients in terms of clinical complexity, disability and multiple comorbidities, as well as personal and environmental needs. We also know how this entails a very flexible and, at the same time, robust and reliable operational capacity on the part of rehabilitation facilities in order to be able to ensure the utmost quality, appropriateness and efficacy for everyone in relation to their Individualized Rehabilitation Treatment Plan. These are in brief the main reasons why I resolved to engage in this work for the definition of quality accreditation standards in Rehabilitation Medicine and in the development of this manual, together with and thanks to the great experience gained by the colleagues at REHA TICINO. These reasons are complemented by our firm belief (mine and of the colleagues who participated in developing the manual) that it is possible and, at the same time, rightful to define organic quality standards that are optimal but realistic in relation to regulations and to the scientific and economic conditions that today govern healthcare and rehabilitation activities (though with some differences across countries), with the extreme respect that each one of us has for Persons with Disabilities, and fully aware of their absolute rights to always receive the best and most effective care, in the most appropriate locations, and by the most suitable staff. The guidelines given by the European Council in the European Declaration on Ensuring the Quality of Medical Care (Budapest 2006), recently consolidated by WHO in the recommendations included in the World Report on Disability (New York 2011), are an absolute point of reference for Rehabilitation and for its continuous development. Professor Alessandro Giustini, M.D. 10 © 2015 REHA TICINO

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Purpose and scope I. Purpose This standard is addressed to all Organizations engaged in rehabilitation, that already possess the specific operational licenses and/or permits to provide rehabilitation services and any other certification or accreditation as required by applicable laws and regulations. The standard is intended to define the necessary infrastructural, organizational, and managerial requirements to ensure high levels of service delivery and, at the same time, to create a system that is documented, objective, and liable to certification by a Third Party Organization. II. Scope The standard applies to Organizations providing inpatient rehabilitation services, including sameday care and/or outpatient rehabilitation services, for patients with: • • • • neurological conditions musculoskeletal conditions cardiovascular conditions pulmonary/respiratory conditions. The accreditation certificate may concern all rehabilitation areas included in the standard or one or more areas. Provided below are a number of useful specifications to better understand how the manual is organized. The first section of the manual contains criteria that apply to all Rehabilitation Centres (RC) seeking accreditation under this programme, regardless of the type of rehabilitation services provided. The second section of the manual includes the distinctive specialty requirements for each of the four rehabilitation areas mentioned above. These requirements are referred to the main diagnosis that determined patient disability, to be understood as both acute and chronic condition. Under this perspective, the so-called “Specialized rehabilitation programmes” (for instance, cancer rehabilitation, psychosomatic rehabilitation, geriatric rehabilitation, post-acute rehabilitation) are cross-cutting categories in comparison with the four rehabilitation areas. All patients, regardless of the specific problems that determined their need for rehabilitation treatment/admission, and as indicated by the modern principles of ICF-based rehabilitation, require to be organically managed with an orientation towards the evaluation of an individual's health conditions and overall potential. This approach is thus connected with each individual's unique © 2015 REHA TICINO 11

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Purpose and scope STANDARDS APPLICABLE TO ALL REHABILITATION CENTRES SECTION 1. © 2015 REHA TICINO 13

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Excellence in Rehabilitation (EiR) 1. GOVERNANCE AND LEADERSHIP ACCOUNTABILITIES In the field of rehabilitation, Leadership support is indispensable to creating and developing an organizational culture that enhances continuous quality and safety improvement. In particular, since the Organization believes that quality – to be understood also as the capacity to meet the expectations of patients/service users – represents the key success factor, it must pursue a modern model of Organization management, aiming for optimal resource utilization. The following standards illustrate the key Leadership responsibilities and accountabilities within an RC. 1.1 The RC defines its mission on the basis of the distinctive features of the rehabilitation programme(s) provided. This also implies defining an organizational rehabilitation plan (i.e. the RC states what rehabilitation settings/programmes the facility is engaged in and specifically equipped/organized for). 1.2 The RC develops a document describing its organizational structure. In particular, there is an organizational chart by function and by name, showing lines of authority and accountability and clarifying staff roles and responsibilities. 1.3 1.4 Responsibilities and accountabilities are carried out in keeping with what Leadership has established. The RC's Leadership ensures, at a minimum, on-site availability of (minimum staffing): • a medical director • a medical team • a nursing team • a team of therapists 1. In addition, the RC ensures availability and accomplishment of the following functions: • administrative director/organizational secretarial staff • quality and risk manager, and data manager • facility safety manager. 1.5 1.6 The RC develops a directive/policy that defines its commitment to the continuous enhancement of quality and patient safety. The RC defines the Organization and resources allocated to quality and patient safety governance. 1 Throughout the standards manual, the term “Therapists” shall include physical therapists, occupational therapists, and other licensed therapists according to national or local legislation. © 2015 REHA TICINO 14

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Excellence in Rehabilitation (EiR) 2. QUALIFIED AND COMPETENT STAFF In order to provide appropriate and effective quality services, professional staff are required to maintain adequate competences for the work they carry out. Health professionals (physicians, nurses, and therapists) are permitted by law to provide services without supervision, each within their specific scope of practice, and this results in patients placing high trust in them. Professional staff are required to enhance and certify their knowledge and skills during their work life. Consequently, ongoing evidence-based learning must be provided to ensure current competences, including the Organization of an in-service education programme targeted on all professional disciplines working in the facility. This programme must include both education provided in the workplace and the possibility for staff to participate in national and/or international educational events relevant to their jobs and disciplines. In addition, an adequate orientation/induction plan must be devised for newly hired staff, that can also help them understand the Organization of the facility they are assigned to. This culture of growth must harmonically structure and support the communication of patient information with other organizations and providers. The following standards address the risk points in human resource management. 2.1 2.2 Each professional working in the RC complies with its code of professional ethics in consideration of service users, stakeholders, and organizational staff. The RC has a designated multidisciplinary care team for each type of rehabilitation programme, as per relevant standard chapter, coordinated and managed by the relevant leaders in each discipline (staffing). 2.3 The RC is led by a certified medical doctor (medical director), who is licensed by law to practice medicine and to carry out responsibilities for rehabilitation treatments, with continuing education and/or specific expertise in one or more of the scopes of rehabilitation activities delivered by the RC. 2.4 2.5 2.6 The medical director is 100% employed in the RC. The RC has a program coordinator, who acts as the medical director's substitute, with the same professional qualifications (see standard 2.3). The RC defines and ensures the availability of a physician in charge (chief physician) for each specialized rehabilitation area (or a named replacement with the same professional qualifications) to provide immediate patient assessment. 2.7 2.8 Nursing staffing levels comply with applicable laws and regulations, and ensure the presence of nursing staff 24/7. The Centre maintains a roster of medical specialists/experts for referrals in their relevant specialized rehabilitation area(s). 16 © 2015 REHA TICINO

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Excellence in Rehabilitation (EiR) 3. WORK ENVIRONMENT AND FACILITY SAFETY The environment of an RC is characterized by the presence of a high number of medical devices and equipment requiring adequate maintenance in order to ensure that equipment is functioning properly and is safe to use for both patients and staff. In addition, hazardous substances and materials may be available for use within an RC. Both staff and patients and visitors are often unaware of the risks encountered in healthcare environments. Consequently, the Organization must disseminate a culture based on environmental safety by means of education and information, and must implement measures to enhance overall facility safety. 3.1 3.2 The RC determines, provides, and maintains the necessary infrastructure and technology for proper and safe performance of activities. The RC has an inventory of available infrastructure and logistics facilities (infrastructure facilities). These include utilities, equipment (including equipment requiring calibration), support services (such as transportation, information systems, backup systems, etc.), buildings, work space. 3.3 The RC identifies: • dedicated space for accommodating patients • separate restrooms for staff and patients • adequate space for exams/visits and for communications with patients and/or families, ensuring respect for the protection and security of privacy and confidentiality, and in keeping with current law. 3.4 The RC provides at least the following basic facilities: • registration area • waiting room for patients and/or families • inpatient areas • dedicated space for outpatient clinics and same-day care units (when included in the services provided by the RC) • easy access for patient transport/transfer • rooms for patient education and clinical interviews • exercise rooms and gyms for delivering one-on-one and group therapy with adequate stations for rehabilitative activities (in keeping with current law provisions and regulations). 3.5 Each RC provides for: • wheelchair access 20 © 2015 REHA TICINO

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Section 1. Diagnosis, treatment and patient care process 4. DIAGNOSIS, TREATMENT AND PATIENT CARE PROCESS The diagnosis, treatment and patient care process consists of clinical services, activities, and treatments planned for by the rehabilitation care team, that form and influence the process for improving the patient's health status or recovery. Within this process, inadequate decisions may occasionally result in patient harm, thus creating more or less severe injuries and/or determining the patient's and family's dissatisfaction. Starting from the assumption that the organizational healthcare system revolves around the patient, then the patient must be actively involved in the decision-making process concerning his or her health. Consequently, it becomes indispensable to define, review and evaluate goals and actions, all of which must be documented accurately and openly. 4.1 4.2 4.3 4.4 4.5 4.6 The Organization defines the rights of patients and families. The Organization respects patient and family rights as identified above. The patient's needs for privacy and confidentiality are protected during care and treatment. Clinical interviews are conducted in adequate rooms to ensure patient privacy and confidentiality. Patients and/or caregivers 3 are involved in the rehabilitation process. The Organization documents and respects the patient's decisions to refuse or discontinue rehabilitative treatment (including decisions with ethical implications, in keeping with professional ethics and current healthcare laws). 4.7 4.8 The Organization obtains the patient's/legal representative's informed consent through a defined process and in keeping with applicable laws and regulations. The Organization obtains an informed consent for the use of measures limiting the patient's freedom of movement (restraint) through a defined process and in keeping with applicable laws and regulations. 4.9 The Organization informs patients and/or caregivers about how to gain access to clinical trials/investigations/research projects, and obtains their consent prior to patient enrolment. The consent must be documented. 4.10 The RC informs and shares with the patient the expected costs for care and services (when the patient will be responsible for the cost of all or a portion of care and services). 4.11 Patient admission to rehabilitation is subject to a clear indication of rehabilitative measures to be provided on an inpatient basis, in terms of potential for functional recovery (patient 3 To be understood in its broadest sense. In other words, reference is made to all kinds of caregivers who may be involved in patient care, including the patient's legal representative and community service providers (e.g. home care services or personal care attendants). © 2015 REHA TICINO 23

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Section 1. Document management system 5. DOCUMENT MANAGEMENT SYSTEM An effective document management system enables an organization to be in compliance with applicable laws and regulations on the one hand and, on the other, ensures traceability of all clinical activities, whilst also ensuring capitalization of knowledge within the Organization. The documents required by the standard include documented statements, required records, and all documents needed to ensure the effective planning, operation and control of the Quality Management System (QMS). Consequently, it is necessary to define a documented quality management system that applies to the activities carried out by the RC. 5.1 The RC reviews the Quality Management System at planned intervals or when major changes are made to the infrastructure, the Organization, human or technical resources (Management Review). 5.2 5.3 The decisions taken as part of the review are recorded and retained. The topics to be addressed during the Management review, concern: • results of internal audits, including clinical audits • previous management reviews • statistics about complaints, if any, and about patient and stakeholder satisfaction • statistics about the monitoring of non-conformities (NC) • status of any improvement actions implemented • changes to the activities, if any • opportunities for improvement identified through internal reporting. 5.4 5.5 Each RC develops a description of its organization and of the services offered, and defines the purpose and scope of the EiR standard. The RC documents and implements a document management system, and specifically defines the processes needed to: • approve the adequacy of documents prior to issue • review, update as necessary, and re-approve amended documents • identify changes to documents, as well as identify their current revision status • make relevant versions of applicable documents available at points of use • maintain documents so that they are legible and readily identifiable • identify any documents of external origin needed to operate the System well, and control their distribution • prevent the unintended use of obsolete documents, and apply suitable identification to these documents if they are kept for any purpose © 2015 REHA TICINO 29

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Excellence in Rehabilitation (EiR) 6. PATIENT SAFETY AND CONTINUOUS QUALITY IMPROVEMENT An Organization that intends to disseminate a culture of continuous quality improvement, must undertake a journey of awareness about its services, whether positive or negative. Data thus become an essential tool to monitor process performance and to plan for quality improvement projects. Leadership which is strong and engaged in continuous quality improvement, can foster an organizational culture that enhances quality and safety. This culture must encourage professional communication, promote reporting and the use of clinical risk management tools, as well as the implementation of best practices in patient care. The RC must incorporate and own these strategies with a view to continuous quality improvement and organizational growth. 6.1 The RC periodically defines (at an established frequency) a programme for quality improvement and patient safety, including issues relating to infection prevention and control. 6.2 6.3 6.4 The RC makes reference to current practice guidelines and EBM for the prevention and control of infections. All staff are educated about the quality and patient safety programme, and about the principles and practices of infection prevention and control. Clinical practice guidelines and clinical pathways have been identified/designed for certain types of patient populations/conditions (see also “Diagnosis, treatment and patient care process” under specialized rehabilitation requirements). 6.5 6.6 6.7 6.8 The clinical practice guidelines and clinical pathways that have been defined are actually implemented. Data about the use of clinical practice guidelines and clinical pathways are useful to understand the barriers to their use and to improve patient management. The RC ensures the management of emergency patients. The RC has written procedures for emergency situations and complication management. In particular, medical emergencies or severe complications are recorded and notified to the Leadership of the RC. 6.9 All staff involved in the cardiopulmonary resuscitation process are trained/retrained in resuscitative techniques at least every 2 years. 6.10 Training in cardiac life support includes a final test to show competency achievement. 6.11 Each cardiopulmonary resuscitation intervention is duly carried out and recorded, in keeping with the provisions of current law and with internal procedures. 32 © 2015 REHA TICINO

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Section 1. Patient safety and continuous quality improvement SETTING-SPECIFIC STANDARDS FOR SPECIALIZED REHABILITATION SERVICES SECTION 2. © 2015 REHA TICINO 35

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