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General Acute Inpatient Care Unit Standars and Recommendations on quality and Safety REPORTS, STUDIES AND RESEARCH 2011 MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

General Acute General Acute Inpatient Care Unit Standars ... · General Acute Inpatient Care Unit Standars and Recommendations on quality and Safety ... Service Head, Nursing Unit,

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    MINISTERIODE SANIDAD, POLTICA SOCIALE IGUALDAD

    GOBIERNODE ESPAA

    www.mspsi.gob.es

    CUBIERTA INGLES General Acute 23/1/12 11:15 Pgina 1

    General Acute Inpatient Care Unit

    Standars and Recommendations on quality and Safety

    REPORTS, STUDIES AND RESEARCH 2011

    MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

  • -Primeras 10/2/12 10:15 Pgina 2

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    General Acute Inpatient Care Unit

    Standards and Recommendations on Quality and Safety

    REPORTS, STUDIES AND RESEARCH 2011

    MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

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    Edita y distribuye: MINISTRY OF HEALTH, SOCIAL POLICY AND EQUALITY

    CENTRO DE PUBLICACIONES PASEO DEL PRADO, 18. 28014 Madrid

    NIPO en lnea: 860-11-226-0

    Catlogo general de publicaciones oficiales http://publicacionesoficiales.boe.es/

    http:http://publicacionesoficiales.boe.es

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    General Acute Inpatient Care Unit

    Standards and Recommendations on Quality and Safety

    GOBIERNO MINISTERIO DE ESPAA DE SANIDAD, POLTICA SOCIAL

    E IGUALDAD

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    List of people involved in compiling the Standards and Recommendations document on quality and safety in hospital units: general acute inpatient care units

    Management and Coordination

    - Ins Palanca Snchez, Office of Planning and Quality, Quality Agency of the SNHS, Ministry for Health, Social Policy and Equality, Management and Technical and Institutional Coordination - Javier Elola Somoza, Technical Management Board, Elola Consultores S. L. - Luisa Gonzlez Cabezas, Scientific Coordinator, Head of the Training Unit, Catalan Institute of Health, Barcelona

    Editing Committee

    - Yolanda Agra Valera, Office of Planning and Quality, Quality Agency of the SNHS, Ministry for Health, Social Policy and Equality - Jos Luis Bernal Sobrino, EC Consultora y Gestin en Sanidad S.L. - Javier Elola Somoza, Elola Consultores S.L. - Beatriz Gmez Gonzlez, Office of Planning and Quality, Quality Agency of the SNHS, Ministry for Health, Social Policy and Equality - Luisa Gonzlez Cabezas, Head of Training Unit, Catalan Institute of Health, Barcelona - Ins Palanca Snchez, Office of Planning and Quality, Quality Agency of the SNHS, Ministry for Health, Social Policy and Equality - Dr Jos Len Paniagua Caparrs, architect

    Panel of experts

    - Luisa Gonzlez Cabezas, Head of Training Unit, Catalan Institute of Health, Barcelona - Mara del Carmen de la Cruz, Chair of the Spanish Association for Surgical Nursing, Nursing Supervisor, Functional Area: Outpatient Consultation/Specialist Centre, Mstoles University Hospital - Magdalena Daz Benavente, Supervisor, Clinical Holistic Healthcare Management Unit, Virgen del Roco University Hospitals, Seville - Ana Gimnez Maroto, Service Head, Nursing Unit, Professional Regulation, Ministry for Health, Social Policy and Equality

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    - Elena Martn Prez, Deputy Secretary of the Spanish Association of Surgeons, Section Head, Princesa University Hospital - Dr Jos Len Paniagua Caparrs, architect - Inmaculada Prez Castro, Care Coordinator, Liver Surgery Unit, Hospital Clnic of Barcelona - Sara Pupato Ferrari, Head of INGESA, Ministry for Health, Social Policy and Equality - Asuncin Ruiz de la Sierra Martn-Gil, INGESA, Ministry for Health Social Policy - Toni Trilla, Quality Coordinator, Hospital Clnic of Barcelona - Antonio Zapatero Gaviria, Spanish Society for Internal Medicine, Head of Internal Medicine Unit, Fuenlabrada University Hospital, Madrid

    Support

    - Alberto Segura Fernndez-Escribano, Office of Healthcare Planning and Quality, Quality Agency of the SNHS, MHSPE - Jos de Arriba Enrquez, Office of Healthcare Planning and Quality, Quality Agency of the SNHS, MHSPE: Publishing Coordinator - Mara Jos Ruiz, EC Consultora y Gestin en Sanidad S.L.

    REPORTS, STUDIES AND RESEARCH 8

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    Contents

    Executive summary 13

    1. Introduction 23

    1.1. The aim of this document 25 1.2. Working methods 26

    2. The current situation 29 2.1. Stadards and recomendations for GAICUs in Spain 32 2.2. Experience in spain and abroad 35

    3. Patients rights and guarantees 43

    3.1. Information for patients, informed consent 43 3.2. Care for carers 45 3.3. Guarantees of patients rights 46

    4. Patient safety 49

    4.1. Culture of safety 53 4.2. Daily visits to the unit 55 4.3. Communication during patient transfer 55 4.4. Safe drug use 56 4.5. Preventing pressure sores 60 4.6. Fall prevention and injury reduction 61 4.7. Preventing infection 63 4.8. Patient identification 63 4.9. Managing blood products 64 4.10. Epidemiology alert 64 4.11. Involving patients in their own safety 64 4.12. Self-protection plan 65

    5. Organisation and management 67

    5.1. Admission criteria 68 5.2. Service portfolio 69 5.3. The patient care process in GAICUs 70 5.4. Relationships with other units 78 5.5. GAICU organisation and operation 80 5.6. Patient management 82

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    6. Layout and material resources 87

    6.1. Functional design 91

    6.2. Medical supplies and sterilising 122

    6.3. Preventing and controlling contagious diseases 122

    6,4. Cleanliness protocol 123

    6.5. Hospital waste management 123

    7. Human resources 125

    7.1. Register of medical staff 125

    7.2. Personal files 125

    7.3. Posts and duties 125

    7.4. Identifying and distinguishing between staff members 127

    7.5. Documentation 128

    7.6. Ongoing training 128

    7.7. Criteria for calculating resources needed 128

    8. Quality 133

    8.1. Authorisation and registration 133

    8.2. Accreditation and auditing 133

    8.3. Quality indicators 133

    9. Revision and follow-up. Criteria for GAICU standards and recommendations 143

    10. Appendices 145

    1. Accreditation criteria for acute care hospitals in Catalonia affecting

    hospital admission 145

    2. Regulations for caring for patients with contagious diseases:

    Types of precaution 149

    3. Specimen drug reconciliation form 153

    4. Levels of care 155

    5. Protocol for assessing suitability of admission 157

    6. Clinical pathway for time spent in a GAICU 161

    7. Modified early warning system 169

    8. Hospital discharge plan 171

    9. GAICU sizing criteria 181

    10. Functional design of GAICU sections 185

    11. Professional framework for the post of nursing supervisor 189

    12. Recommendations for GAICU nursing staff levels 195

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    13. Glossary 197

    14. Abbreviations and acronyms 203

    15. Bibliography 205

    Tables

    1.1. Classification of levels of care 24

    2.1. GAICU activities 29

    2.2. Acute care hospital beds (in public and private hospitals)

    per 1000 inhabitants in the EU 30

    2.3. Average length of stay in acute care hospitals (public and private)

    in the EU 31

    2.4. Regulations for authorising medical institutions 33

    6.1. Features of GAICU entrance and reception area 94

    6.2.. Features of nurses station and utility rooms 100

    6.3. Features of patients rooms and bathrooms 106

    6.4. Features of general utility rooms 109

    6.5. Features of staff area 111

    6.6. Features of the units general transit routes 113

    6.7. List of all GAICU resources 114

    6.8. List of equipment by area 115

    8.1. Quality and care indicators for GAICU 140

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    Executive summary

    1. A general acute inpatient care unit (GAICU) is defined as a facility staffed by healthcare professionals and providing multidisciplinary care in a specific area within a hospital. It meets certain functional, structural and organisational requirements, ensuring appropriate levels of safety, quality and efficiency to care for patients with acute conditions or acute exacerbations of chronic conditions who have been admitted for medical or surgical procedures and require neither advanced or basic respiratory support nor support of one or more organs or systems.

    2. A GAICU is an intermediate unit that provides services (mainly nursing care, but also catering) for patients receiving care (diagnosis and/or treatment) from clinical services, usually medical or surgical services. In order to operate smoothly, it must be integrated into and coordinated with almost all other units in the hospital.

    3. In 2007 there were 3.7 million hospital discharges relating to internal medicine and medical fields, surgery and surgical fields and orthopaedic surgery and trauma medicine, the fields that usually use GAICUs. Total use by these three groups of specialist fields in 2007 was 82 admissions per 1000 inhabitants, with an overall average length of hospital stay of 6.8 days.

    4. The current changes in hospitals that most affect a GAICUs organisation, management and operation are as follows:

    Fewer acute care inpatient beds Shorter average length of stay Stable numbers of hospital users Outpatient resolution of processes that used to require hospital

    admission Patients admitted to acute care hospitals are more seriously ill

    and more heavily dependent, and require more technologicallyadvanced, more intensive care

    A considerable proportion of patients cared for at GAICUs have multiple chronic conditions with episodic exacerbations and high dependency levels. This makes it important to guarantee continuity of care and the integration of healthcare teams.

    5. Major changes have taken place in nursing, including the following:

    More nurses per bed in acute care hospitals Changes in the organisation and management of care due to re-

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    engineered or redesigned processes. The organisation of nursing and its relationship to other professions is changing

    Changes in nursing workloads

    6. GAICUs must provide patients with general information on the nature of the unit, and detailed information on the process, diagnosis, treatment and care at the unit. This information must be clear, accurate and sufficient. It is recommended that the leaflet or brochure provided to patients or carers the first time they deal with GAICUs should include warnings or advice on accessing or using the GAICU, and photographs to aid understanding of how the unit works.

    7. Patients should be involved in their own healthcare as part of any healthcare strategy, particularly with a view to patient safety.

    8. Safety and the defence of patients rights should be governed by written protocols.

    9. Patients written consent is required for both invasive diagnostic and therapeutic procedures and the administration of treatments with known risks and discomforts and a foreseeable negative impact on patients health.

    10. Efforts to establish and maintain a culture of safety in hospitals must be supported. This is considered a decisive step towards improving patient safety.

    11. Regular GAICU team meetings are recommended to provide systematic analysis of any safety incidents that may have occurred in the GAICU, and in particular to put in place appropriate prevention measures.

    12. Information on patient safety and practices based on scientific evidence which have been effective in reducing errors should be updated regularly, so that the introduction of new measures that may be useful can be considered and continual improvements in the safety of patients cared for at the GAICU can be put into practice.

    13. There should be up-to-date evidence-based treatment protocols and/or drug use guidelines for the main illnesses treated at the GAICU.

    14. A standardised procedure should be used to compare and reconcile patients pre-admission medication with medication prescribed on admission to the GAICU.

    15. Treatment must be kept as simple as possible. When medication is prescribed its dose must be systematically adjusted to the patients age, kidney function and liver function. We recommend implementing an electronic prescription system integrated into patients medical records, to provide an alert when drug doses need to be adjusted. Drugs considered inappropriate for the elderly because they present an unfavourable risk/benefit ratio for them and there are other treatment options must be

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    avoided. These drugs should be included in the alerts of the assisted electronic prescription system.

    16. Discharged patients should be given a complete (and reconciled) list of medication to submit or send to the professionals who will be in charge of their continued care.

    17. The procedure for regularly reappraising all patients medication should be coordinated with primary care, in order to decide whether the medication prescribed is appropriate and continued treatment is necessary.

    18. GAICUs must develop and implement a pressure sore prevention programme, including identification of at-risk patients and assessment of skin status.

    19. GAICUs must develop and implement a fall prevention programme including identification of patients at risk of falling, multidimensional risk assessment and a multi-factor strategy to reduce the risk of falling.

    20. GAICUs must have an infection monitoring and prevention programme suited to their characteristics and activities, including identification of at-risk patients. GAICUs must have and apply protocols on hand hygiene, use of alcohol-based solution, use of antiseptics, antibiotic prophylaxis and prevention of infection for invasive procedures.

    21. Tailor-made care plans must include local skincare, specific prevention for incontinent patients and changes of position for patients with limited mobility.

    22. Care plans must include care for carers, particularly with patients presenting substantial cognitive or functional deterioration.

    23. GAICUs must have systems that identify patients unambiguously.

    24. There must be protocols for the medical and nursing activities involved in the processes and procedures most frequently handled/ performed at the GAICU.

    25. Clinical pathways should be developed. These are clinical management tools that standardise the process from a multidisciplinary perspective.

    26. The GAICU must guarantee the following for inpatients:

    Allocation, introduction and identification of the doctor in charge their care

    Allocation, introduction and identification of the nurse in charge of their care on each shift

    Initial nursing assessment and recording of vital signs on admission A monitoring plan specifying which variables and parameters must

    be recorded and how often

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    Medical assessment, information (informed consent where applicable), application for additional examinations and prescription of treatment if necessary

    Nursing activities: holistic assessment of health problems, data collection, implementation of care plan and development of interventions to be performed by the units nurses and those delegated to others

    27. Track and trigger systems are recommended. These provide a systematic framework for monitoring patients in GAICUs.

    28. The critical care unit and the GAICU should work together to ensure continuity of care via an extended critical care service that might be defined as a multidisciplinary approach to identify patients at risk of becoming critically ill and those recovering from a period of critical illness, in order to allow early intervention or transfer (if indicated) to a suitable area to care for these patients needs. This service must also improve the skills and knowledge of all staff involved in providing critical care.

    29. Hospitals must establish and regularly review the thresholds of the extended critical care teams track and trigger systems, in order to make them as sensitive and specific as possible. Hospitals must set graded response policies for patients whose clinical condition deteriorates.

    30. Communication between the professionals involved in patient care should be made more effective. This concerns daily visits to the unit, shift changes, patient transfers between units and patient discharges.

    31. The unit should be visited by a multidisciplinary team. 32. Multidisciplinary visits to the unit should be part of the care

    routine. They should therefore be governed by an agreement between professionals. It is advisable for such visits to include at least the doctor and nurse in charge of patient care. Other professionals must arrange with the head of the GAICU to take part in visits when necessary. The use of an official information-exchange system and multidisciplinary visits has been associated with a 15% decrease in average length of stay, greater satisfaction with the care provided and better communication and cooperation between the professionals involved.

    33. Daily visits are recommended as a measure to boost the quality, safety and efficiency of care in GAICUs. Visits should also take place on Saturdays, Sundays and public holidays, as this prevents patients well enough to be discharged from remaining at the GAICU. Visits should take place first thing in the morning, as this facilitates bed management.

    34. An official information-exchange system or communication system for use by professionals at shift changes is recommended.

    35. Communication between professionals when patients are

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    transferred between different care units should be standardised. GAICUs must guarantee continuity of care while patients are being transferred between different hospital units. A structured system based on the written care plan must be formally established. Responsibility for patient care is shared between the unit transferring the patient and the unit to which the patient is transferred. This ensures that the GAICU, with the support of the extended critical care service, can put into practice the care plan agreed upon. Patient transfers from a unit providing more intensive care to the GAICU should be performed as soon as possible once indicated. Patients must not be transferred between 10pm and 7am unless unavoidable. If a patient is transferred between these times, this must be recorded as an adverse event.

    36. The discharge process should be standardised, to ensure that key information on diagnoses on discharge, the results of tests performed, the treatment plan, care and medication are available. Discharge must be planned as soon as a patient is admitted to the GAICU. The following are recommended:

    Early planning of discharge of GAICU patients GAICUs must be organised so that discharges can be processed on

    Saturdays, Sundays and public holidays just as effectively as on other days

    GAICUs must have access to referral staff (a community liaison nurse/case manager and/or social worker) who coordinate healthcare resources, extended care resources and social resources to ensure continuity of care

    Medical discharge reports should be accompanied by nursing discharge reports. Each GAICU discharge report must contain an action plan that states treatment targets and clinical follow-up. Discharge reports must be made available to the professionals in charge of continuity of care (primary care doctor and nurse)

    Delays to discharge management caused by a shortage of transport to take patients home should be avoided

    37. There should be communication between the GAICU and the subacute care unit to guarantee early rehabilitation for patients with ictus or hip fractures and elderly patients with functional deterioration from their baseline status secondary to recovery. This is to reduce the dependency of such patients once the acute phase of their illness or injury has stabilised. The subacute unit may be located either in or near to the hospital.

    38. There should be support services that guarantee quality of care.

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    In order to ensure quality and continuity of patient care, GAICUs must have 24-hour access to surgery and radiology and laboratory tests and the intensive care or intermediate care unit.

    39. GAICUs must have a guaranteed supply of blood components for transfusions and guaranteed access to patient transport for emergency transfers. They must have supplies of sterile materials and drugs at all times and guaranteed food, maintenance and repair services.

    40. Each GAICU must have a care coordinator (care manager or supervisor) who is in charge of coordinating the nursing staff allocated to the GAICU.

    41. The names of the GAICU care coordinator, care manager, supervisor and anyone to whom these responsibilities are delegated must be public knowledge. They must therefore be stated in the units operating regulations.

    42. GAICUs must have nursing staff and allocate a main nurse to each patient, who will plan the patients care. Each shift must include a nurse in charge of each patients care, who will apply the care planned by the patients main nurse. The nurse must introduce him-/herself to the patient and any relatives or carer at each shift change.

    43. There should be a doctor in charge of each patients care during the patients stay at the GAICU. This doctor must be clearly identified and introduce him-/herself to the patient and the patients family/carer. GAICU must have specialist physicians in the field involved in the care provided to the units patients.

    44. GAICUs must employ porters and staff who transport patients. 45. It is appropriate for social workers, dieticians/nutritionists,

    physiotherapists and pharmacists to work with GAICUs. 46. Each GAICU must have an organisation and operation

    handbook that includes its organisation chart, service portfolio, layout, structural resources, equipment and regulations.

    47. Beds must be allocated from the patient management unit. With the exception of hospitals with small numbers of beds, it is advisable for hospitals to make a distinction between admission for medical and surgical reasons when allocating patients to GAICUs. GAICUs and beds should not be allocated rigidly by specialist field, although depending on the volume of healthcare provided GAICUs or beds may be allocated to various different fields. Allocation should vary in line with fluctuations in demand.

    48. Hospitals must have a single register of medical records that contains all information on the activities performed at the hospital. Each patient must have a single set of medical records, shared by all staff. Ideally, medical records should be accessible to and shared by other medical institutions and levels of healthcare with responsibility for patient care.

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    49. Nursing staff should spend 70% of their time on direct patient care (and 90% on activities that add value to the healthcare process). University-qualified nurses must manage, assess and provide nursing care intended to promote, maintain and restore health and to prevent illnesses and incapacity. Nursing activities within GAICUs rely on the smooth operation of the units and services that work with GAICUs and are affected by structural, functional, equipment-related and facility-related issues. The way in which medical activities are organised has a substantial effect on how nursing staff use their time. Appropriate organisation and operation of the hospital as a whole (imaging diagnostics, laboratory procedures, patient management, cleaning, maintenance, repairs, etc.) play a major part in nursing staff being able to organise their own activities.

    50. Hospitals should calculate nursing staff numbers in line with the needs identified for each unit and shift. The recipient of nursing care is the patient, not the bed. The number of GAICU staff needed varies according to the number and complexity of care of patients admitted and the GAICUs service portfolio.

    51. GAICUs must have separate lifts for visitors, beds and supplies. 52. GAICUs must be free of any fixed obstacles, particularly in

    patients bathrooms. 53. The movement of patients and visitors around GAICUs must be

    separate from other facilities. GAICUs must not connect other units. 54. GAICUs must contain the following areas: entrance and

    reception area, patient and family area, nurses station and utility rooms, general utility rooms, staff area, corridors for general movement around the unit.

    55. GAICU resources must be used both to guarantee patients care, safety and comfort needs are met and for nursing functions when patients are admitted. The main users of a GAICU are inpatients and nursing staff.

    56. GAICU must have space for doctors to work. 57. The units general corridors must be wide enough for two beds to

    pass each other (minimum width 2.20 m), and for a bed to be turned when entering or leaving a ward. Their design must be similar to that of residential buildings.

    58. The nurses station must be located so that the average distance to patients is as short as possible. The average distance between the nurses station and patients should be no more than 30 metres. The maximum recommended distance between the nurses station and patients (the most distant patient room) is 45 metres. Layout, facilities and equipment have a significant effect on nursing staffs efficiency. Wards with few beds, distances over 30 metres between the nurses station and patient rooms, inadequate systems for communication between patient rooms and the nurses station,

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    unsuitable beds (or transport on stretchers), a lack of automatic sample transport and collection systems, single-dose systems and material replacement systems (double-box systems), etc. reduce nursing staffs performance. In contrast, if these measures are in place performance should rise.

    59. All patient rooms in GAICUs must be fitted with communication and computer facilities, particularly at the heads of patients beds. The heads of patients beds must contain electric sockets and medical gas points.

    60. GAICUs should have between 28 and 36 beds in use. 61. It must be possible for patients to be accompanied at all times.

    There must be resources for this both in patients rooms and elsewhere in the GAICU.

    62. GAICUs must have single rooms, and it is recommended that at least 50% of their rooms should be single. Single rooms must be large enough to serve as double rooms, so that GAICUs can adapt to seasonal increases in demand.

    63. GAICUs must be designed to provide patients with comfort, safety and privacy. Lighting, views and acoustics are essential aspects of the location, orientation and design of GAICUs and patients rooms.

    64. Each patients room must have free space around the bed so that clinical and nursing staff carrying equipment (crash trolley) can reach the patient. Each room must have a cupboard for the patients belongings during his/her stay in hospital.

    65. Each patients room must have a bathroom (containing a washbasin, toilet, shower and bedpan washer). It must be possible for a wheelchair to enter and move around the bathroom with assistance, and there must be no fixed obstacles.

    66. GAICUs must be fitted with pneumatic sample and document transport systems. They must have enough space to dispense drugs and provide the materials necessary for patients healthcare (providing treatment, taking samples, etc.) and accommodation (food, linen, cleaning, etc.). Whether these storage and distribution areas are available depends on the hospitals supplies policy and management.

    67. A proposed set of GAICU monitoring indicators includes caseadjusted average length of stay (SAALS), function-adjusted average length of stay (FAALS), hospital mortality, number of life-threatening emergency codes per 1000 days hospital stay, readmission rate, adverse drug reaction reporting rate, hospital infection rate, transfusion reaction rate, fall rate, pressure sore rate and staff and patient satisfaction indices.

    68. Use of the complexity-adjusted average length of stay (CAALS) is recommended. CAALS can be used to compare the processes catered for

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    by a particular hospital or healthcare service, divided into diagnosis-related groups (DRGs), with the average for the Spanish National Health Service (SNHS) and so determine the approximate number of days of inappropriate hospital stays. Inappropriate admission is admission of a patient who should be cared for on an outpatient basis (major outpatient surgery or daytime hospitalisation). Between 2.1% and 44.8% of admissions to Spanish hospitals are inappropriate. The possible incidence of inappropriate or unnecessary days of hospital stay in Spain ranges from 15% to 43.9%. The Quality Agency (QA) of the SNHS divides processes and procedures into DRGs using the classification system ICD-10-CM. DRGs are used to structure for the portfolio of clinical processes catered for at a particular GAICU. The international nursing care classification system is not generally used.

    69. This report should be revised and updated no more than ten years after its initial publication. In order to improve this knowledge as the foundations for evidence-based, or at least experience-based, recommendations, the next review should include systematic analysis of GAICU indicators, including all those recommended in this report, in addition to the subjects covered in this document.

    70. Some of the recommendations in this document concern relatively new aspects of organisation and management, or aspects that reintroduce processes into GAICU organisation and management that have been abandoned: daily multidisciplinary visits to the unit (including on public holidays), extended critical care, systematic implementation of early discharge planning, convalescence units managed by nursing staff, etc. Pilot projects evaluating the costs and benefits of implementing these organisational and management tools should be run.

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    1. Introduction

    Articles 27, 28 and 29 of Spanish Law 16/2003 of 28th May 2003 on Cohesion and Quality in the Spanish National Health Service (SNHS) stipulates that safety and quality guarantees agreed within the Cross-Regional Board of the SNHS must be developed. These guarantees must be compulsory in order for the authorities of Spains autonomous regions to regulate and authorise the opening and operation of medical centres, units and institutions on their territory.

    Spanish Royal Decree 1277/2003 of 10th October 2003, which establishes the general foundations for the authorisation of medical centres, units and institutions, defines and lists those for which requirements to guarantee quality and safety must be established. Unit 2 of the range of healthcare described by these regulations, Nursing, is defined as a medical unit in which nursing staff are responsible for performing functions and activities appropriate to their qualifications.

    In the Spanish Ministry for Health, Social Policy and Equalitys series of Standards and Recommendations documents for medical units, a medical unit is defined as a facility staffed by healthcare professionals and providing multidisciplinary care in a specific area within a hospital. It meets certain functional, structural and organisational requirements, ensuring appropriate levels of safety, quality and efficiency to care for patients with particular characteristics that determine the details of the units organisation and management.

    General (medical/surgical) acute inpatient care units (GAICUs), the subject of this Standards and Recommendations document, delimit the following aspects of the definition of a nursing unit provided in Royal Decree 1277/2003 as follows:

    Nursing units in acute care hospitals. These are defined in Royal Decree (RD) 1277/2003 as C.1. Hospital (centre with inpatient facilities): a medical centre intended to provide continuous specialist care for inpatients (patients admitted for at least one night), the main aim of which is the diagnosis or treatment of patients admitted, though they may also provide outpatient care. Under the heading of hospitals, Statistics on Medical Institutions with Inpatients, issued by Spains National Statistics Institute (INE) and Ministry for Health, Social Policy and Equality (MHSPE) categorises general hospitals and specialist hospitals (other acute care hospitals) as acute care hospitals1:

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    C.1.1. General Hospital: A hospital intended to care for patients suffering from various disorders, providing medical, surgical, obstetric and gynaecological and paediatric care. A hospital is also considered to be a general hospital if one of these areas is absent or underdeveloped but most of the hospitals healthcare is not concentrated in one specific area.

    C.1.2. Specialist Hospital: A hospital provided with specialist diagnosis and treatment services and that mainly provides care for specific disorders or for patients in a particular age group or with common features.

    Because of this, this Standards and Recommendations document does not apply to nursing units in functional rehabilitation units or hospitals, medium- or long-stay nursing units, or intermediate care units2,3,4(1).

    It cares for adult patients with acute disorders (or acute exacerbations of chronic disorders), both medical and surgical (i.e. it is general). It therefore excludes neonatal, obstetric, paediatric and mental health admissions.

    Care levels 0 or 1 according to the following classification system, which is taken from the UKs Department of Health (Table 1)5. It therefore excludes critical care units, including intensive care, post-anaesthetic recovery, coronary care, burns and hospital A&E units.

    Table 1.1. Classification of levels of care

    Level Description of care needs

    0 1

    2

    3

    Patients whose needs can be met through normal ward care in an acute hospital. Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice and support from the critical care team.

    Patients requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those stepping down from higher levels of care.

    Patients requiring advanced respiratory support alone or basic respiratory report together with support of at least two organ systems. This level includes all complex patients requiring support for multi-organ failure.

    Source: Comprehensive Critical Care, Dept. of Health (2000)

    (1) Intermediate care units provide nursing care only. This should not be confused with what is described in Spain as cuidados intermedios, or intermediate care, which corresponds to critical care levels 1 and 2.

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    The classification system of the UKs Department of Health is based on patients care needs, rather than the physical resources available at the facilities providing care6,7,8,9.

    This means that a general acute inpatient care unit can be defined as a facility staffed by healthcare professionals and providing multidisciplinary care in a specific area within a hospital. It meets certain functional, structural and organisational requirements, ensuring appropriate levels of safety, quality and efficiency to care for patients with acute conditions or acute exacerbations of chronic conditions who have been admitted for medical or surgical procedures and require neither advanced or basic respiratory support nor support of one or more organs or systems.

    To the definition of a hospital provided in RD 1277/2003 we can add a broader description of the services GAICUs must provide in order to meet their essential purpose, which is to provide continuous inpatient care. Millers definition10 of hospital, used by Mickey and Healy11, addresses these issues:An institution that provides beds, food and continuous nursing care for patients receiving treatment scheduled by medical professionals, with the aim of restoring their health. Although Millers definition also contains other matters of interest, two aspects essential to defining the purpose of nursing units in hospitals have been highlighted: the provision of continuous nursing care and catering.

    The role of nursing in improving hospitals quality, safety and efficiency is considered comparable to that of medical advances and improvements to buildings and facilities in the nineteenth century12.

    GAICUs are intermediate units that provide services (mainly nursing care, but also catering) for patients receiving clinical care (diagnosis and/or treatment), generally medical or surgical care. In order to operate well they must work and be coordinated with almost all the hospitals other units.

    1.1. The aim of this document

    Strategy 7 of the Quality Plan of the Spanish National Health Service (QP, SNHS) reads as follows: To accredit and audit medical centres, services and units; the primary goal is to establish basic common requirements and safety and quality guarantees that must be fulfilled in order for the SNHSs medical institutions to open and operate.13

    In 2007 the MHSPE updated the major outpatient surgery (MOS) guideline14 published in 199315 as part of the QP, SNHS, and developed its safety and quality standards and recommendations for daytime hospitalisation units for medical and oncological/haematological indications16. In 2008, Standards and Recommendations documents for

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    units for patients with multiple chronic conditions17, hospital maternity units18 and surgery suites19 were developed.

    This Standards and Recommendations document for GAICUs aims to provide public healthcare authorities, public and private managers and professionals with criteria for organising and managing units of this type and thus help improve the safety and quality of service provision, and to establish criteria for designing and equipping GAICUs.

    The Standards and Recommendations document for general acute inpatient care

    units is not a legal document: It does not establish the minimum requirements for the

    opening and/or working conditions of these units or for their accreditation.

    1.2. Working methods

    This document covers the following subjects:

    a) Patients rights and guarantees b) Patient safety c) Criteria for organising and managing GAICUs d) GAICUs layout and material resources e) GAICUs human resources f) Factors affecting GAICU care quality g) Review and follow-up of standards and recommendations for

    GAICUs

    The Healthcare Planning and Quality Office of the QP, SNHS within the MHSPE has overseen the compilation of this Standards and Recommendations document in the framework established by the QP, SNHS.

    The document was written by a group of experts selected for their experience and knowledge of subjects connected with its scope, and appointed by scientific societies and professional associations, on the same basis.

    The scientific coordinator of the work was Luisa Gonzlez Cabezas, Director of the Training Unit of the Catalan Institute of Health, Catalonia.

    A support group has also assisted the QA, SNHS by providing secretarial support for the group of experts, following up work, providing technical assistance at the groups meetings, conducting current situation

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    analysis, reviewing documents written by the experts and analysing evidence, and contributing to the successive drafts and the final document.

    The GAICU Standards and Recommendations document is based on extensive experience both within Spain and abroad, as stated in Appendix 15.

    This report includes some strong recommendations. This means that they are either supported by legal requirements or based on evidence which is sufficiently sound according to the group of experts involved in compiling the report. These strong recommendations will be explicitly described as such and will appear in bold type.

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    2. The current situation

    The 2007 document Statistics on Medical Institutions with Inpatients1 shows the following information on GAICU discharges (internal medicine and medical fields; general surgery and surgical fields; trauma medicine):

    Table 2.1: GAICU activities

    Field

    SNHS hospitals Private hospitals Total

    Discharges Hospital stays Discharges Hospital stays Discharges Hospital stays

    Internal medicine

    Surgery and surgical fields

    Trauma medicine

    Total

    1,407,963 12,521,636 315,402 2,082,859 1,723,365 14,604,495

    942,889 5,983,146 429,339 1,154,608 1,372,228 7,137,754

    356,219 2,608,143 247,348 873,711 603,567 3,481,854

    2,707,071 21,112,925 992,089 4,111,178 3,699,160 25,224,103

    FSource: SMII, 2007 (MHSPE). Authors estimates.

    In summary, with 3.7 million discharges the overall admission rate for these three groups of specialist field in 2007 was 82 admissions per 1,000 inhabitants per year, with an overall average length of stay of 6.8 days.

    GAICU organisation, management and operation depend on the nature of the hospital in which a GAICU is located, which in turn depends on the healthcare system of which it is part. This makes it impossible to provide international comparisons of GAICUs that are not contaminated by variables determined by features of the hospital or healthcare system (or subsystem) that have a decisive impact on GAICU operation. However, there is a substantial amount of information on the management of GAICUs that can be used to identify practices that allow activities to be performed with appropriate levels of quality, safety and efficiency. In addition, the organisation, management and operation of GAICUs in Spain are in line with acute care hospitals in developed Western countries and the EU, and follow the same trends.

    The scope of this document does not include a description of the hospital of the future for the SNHS. Only the trends in hospital development that most seem to influence the organisation, management and operation of GAICUs are stated here. These trends are as follows:

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    Fewer acute care hospital beds: in the last 15 years the number of acute care beds per 1000 inhabitants has fallen by an average of 15% in the EU15 countries. This is shown in Table 2.2:

    Table 2.2. Acute care hospital beds (in public and private hospitals) per inhabi

    tants in the EU

    EU-15 1990 2004

    Austria 7.5 6.1 18.7% Belgium 5.2 4.4 15.4% Denmark 4.1 3.3 19.5% Finland 4.3 2.9 32.6% France 5.2 3.7 28.8% Germany 8.3 6.4 22.9% Greece Republic of Ireland 3.2 2.8 12.5% Italy 6.2 3.3 46.8% Luxembourg 6.7 5.2 22.4% The Netherlands 3.8 3.1 18.4% Portugal 3.4 3 11.8% Spain 3.6 2.9 19.4% Sweden 4.1 2.2 46.3% UK 3.6 3.1 13.9% Average 4.4 3.7 14.8%

    Source: Eco-Health, OECD 200720, July 2007; non-weighted average Countries for which no data are available for the two years shown have not been included.

    Healthcare systems based on the national health service model tend to have fewer acute care beds than those based on the health insurance model.

    The decrease in the number of acute care beds is partly the result of their being replaced by beds in extended care or social facilities21.

    Shorter average length of stay: Table 2.3, which is taken from the same source and covers the same period and criteria, shows a 32% average decrease in length of stay in the EU-15 countries.

    Stable hospital admission rate: the hospital usage rate (number of discharges per 1,000 inhabitants per year) has stabilised or increased slightly, but not enough to compensate for the decrease in average length of stay in EU countries, including Spain22, and in the USA23.

    Outpatient resolution of processes that used to require hospital admission: this trend has been seen mainly in the area of major surgery, as a

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    ,3,3

    ,3

    itals (

    90 2005

    9.3 5.9 36.56%

    6.4 3.5 45.31% 7 4.8 31.43% 7 5.4 22.86% 6.7 8.6 48.50%7.5 100.00% 6.7 6.6 1.49%

    7.3 0 6.8 32.00% 8.4 7.1 15.48% 9.6 6.7 30.06%6.5 4.6 29.23% 9.5 6.1 35.79% 8.8 6.0 31.91%

    public and private) in re hosp

    19

    1

    1

    ute caTable 2.3. Average length of stay in ac

    the EU

    EU-15

    Austria Belgium Denmark Finland France Germany Greece Republic of Ireland Italy Luxembourg The Netherlands Portugal Spain Sweden UK Average

    result of developments in MOS15, and probably DH, associated with diagnosis and treatment procedures.

    Patients admitted to acute care hospitals are more seriously ill and more heavily dependent, and require more technologically-advanced, more intensive care. This is a result of the trends outlined above and the gradual ageing of the population in developed Western countries.

    A considerable proportion of patients cared for at GAICUs have multiple chronic conditions with episodic exacerbations17 and high levels of dependency. This makes it important to guarantee continuity of care and the integration of healthcare teams24 (2).

    Major changes have also taken place in nursing.The USAs Institute of Medicine (IoM) highlights the following, among other25 (3):

    More nurses per bed in acute care hospitals: between 2000 and 2005 the ratio of qualified nursing staff (RNs, university-qualified nurses, matrons and physiotherapists) per 100 beds rose by 18.5% (from 92.5 to 109.7), and the corresponding ratio for total nursing staff rose by 17% (from 162.6 to 191.1)21(4).

    (2) One of the initiatives of the NQF (www.qualityforum.org) is to evaluate the long-term efficiency of episodes of care. The documents available on this subject are drafts, and so cannot be cited. (3) Some of the factors driving changes, or changes themselves, are specific to the USA and have therefore been omitted from this summary. Others have been adapted. (4) The IoMs publication emphasises that this increase has not necessarily been accompanied

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    http:www.qualityforum.org

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    Changes in the organisation and management of care due to reengineered or redesigned processes. This involves cross-training staff for new activities, changing the workforce structure or reassigning nursing staff from clinical support services (imaging diagnostics, laboratory) to clinical units.

    Re-engineering and redesigning processes has also affected the following:

    How nursing is organised and its links with other professions The expanding role of nursing in care provision26.

    Both these phenomena have generated a substantial number of studies and publications on the best way to organise nursing work. The IoM27 concludes that probably no one service provision model is better than any other, as models must adapt to each units structure, processes and resources due to variations between nursing units in terms of levels of experience, support staff, patient needs and resources.

    Changes in workloads (5): the trends outlined above lead to an environment of change in the organisation and management of healthcare systems themselves, hospitals and GAICUs within hospitals.

    One of the aspects highlighted by the IoM and other US institutions such as the Joint Commission, the Agency for Healthcare Research and Quality (AHRQ) and the National Quality Forum (NQF) is the relationship between suitable nursing staff levels and patient safety28,29,30,31, particularly in ICUs.

    2.1. Standards and recommendations for GAICUs in Spain

    Both the central Spanish government and all Spains autonomous regions have regulations on the authorisation of registration of medical

    by an increase in the amount of time nursing staff spend on direct care (applicable to the SNHS).(5) The IoMs publication cites various studies that analyse workloads. One of these, conducted in a sample of 55 hospitals in California, included 330 nursing units (intensive care, critical care and general). Nurses provided 92% of care in ICUs, 87% in critical care units and 57% in general care units. The number of patients per nurse in these units varied as follows: 0.5-5.3 in ICUs (mean 1.6); 1.5-11.6 in critical care units (mean 4.2); 2.7-13.8 in general units (mean 5.9). In general units, a study of 135 hospitals in the USA found a mean of 1 nurse for every 6 patients on the morning shift, the ratio ranging from 1:3 to 1:12. In critical care units the mean was 1:2 on each shift.

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    Table 2.4: Regulations for authorising medical institutions

    Aragon A Department of Health and Consumer Affairs Decree dated 8th March 2006, which governs the minimum requirements for the authorisation of surgical institutions in the Autonomous Region of Aragon, stipulates that institutions in which surgical procedures are performed must have 24-hour medical and nursing care. It defines a functional nursing area and states some characteristics of the nurses station, utility rooms and patients rooms. It does not stipulate staff ratios.

    Canary A Regional Ministry for Health and Consumer Affairs Decree dated 15th June Islands 2000, which establishes the minimum requirements to be met by hospitals in

    the Autonomous Region of the Canary Islands, stipulates that general hospitals must have a general admissions area and states some of the features it must have.

    centres, services and establishments. There are two types of regulation: those on authorisation and registration, which assess centres before they open, and those on accreditation, which assess them when they are up and running.

    2.1.1. Authorisation

    All autonomous regions have regulations on the authorisation of medical centres, units and institutions. Since RD 1277/2003 was issued ten autonomous regions have brought their own legislation into line with it, while the remaining seven have made no changes to their laws. Table 2.4 shows the regulations for authorising medical institutions that affect GAICUs.

    2.1.2. Accreditation

    Accreditation is defined as a process by which an organisation voluntarily submits to a system of external verification that uses a set of standards to assess and measure the organisations status with regard to a set of preestablished benchmarks agreed on by experts and adapted to the geographical area.

    Spains healthcare services have little experience of accreditation. Four autonomous regions (Andalusia, Catalonia, Galicia and Extremadura) have official regulations and programmes for medical institution accreditation. They are based on external evidence and are voluntary. There

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    are some accreditation programmes for particular types of centre, service or activity (organ removal and transplant, assisted reproduction, haemotherapy, etc.).

    Andalusias accreditation system is based on the Accreditation Programme for Institutions Within the Andalusian Healthcare System (6). This is based on a reference model that includes a series of standards which are characteristic of the Andalusian Public Health Service. None of the indicators in its system refer specifically to GAICUs.

    Catalonia was the first autonomous region to develop an official procedure for accrediting medical institutions. Its current system is its third (7). It regulates the accreditation of acute care hospitals and the procedure for authorising assessment bodies. There are also two accreditation guides which include the established standard32,33. There are specific accreditation criteria for the hospital admission process, and other criteria that affect GAICUs (Appendix 1).

    In 2001, the Autonomous Region of Galicia established a hospital accreditation system regulated by decree (8). This applies to hospitals within the network of the Galician Health Service. Those that have signed contracts with the Galician Health Service or wish to do so must obtain the accreditation certificate stated in the decree. On the subject of GAICUs, it states that general hospitals must have a suitably arranged and organised nursing area for the nursing care needed by the hospitals patients, and establishes the organisational requirements for this area. It also defines the inpatient area as a physical space for the care of inpatients with guarantees of comfort, safety and quality of care. It lays down organisational, structural and functional requirements for this area.

    Like Andalusia and Galicia, Extremaduras 2005 medical institution accreditation system targets both outpatient and inpatient centres in general and makes no reference to GAICUs (9).

    (6) Resolution of the Directorate for Process Organisation and Training dated 24th July 2003, which establishes the quality accreditation system for medical institutions and units within the Andalusian Public Health System. (7) Decree 5/2006 of the Government of Catalonia dated 17th January 2006. Resolution SLT/1325/2006 of 29th March 2006, which publishes the Agreement for Government of the Government of Catalonia of 28th March 2006, approving the accreditation standards governed by Article 4 of Decree 5/2006 of 17th January 2006 on the accreditation of acute care hospitals and the procedure for authorising assessment bodies. (8) Galicia, Decree 52/2001 of 22nd February 2001. (9) Extremadura, Decree 227/2005 of 27th September 2005, Decree of 18th July 2006.

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    2.1.3. Unit guide

    Both the MHSPE and autonomous regions have published guides for some units, which though not legally binding aim to establish standards and recommendations. No guidelines on GAICUs have been found.

    2.2. Experience in Spain and abroad

    As stated in the introduction to this chapter, international comparisons can be used to identify common trends and good practices of proven quality and efficiency. This addresses the difficulty of comparing GAICUs in different healthcare systems and hospitals with major differences in their organisation, management and operation.

    2.2.1. Spain

    Spains National Study of Adverse Effects Associated with Inpatient Care34

    gave an estimated incidence of adverse effects (AEs) directly connected to inpatient care of 8.4% (1.4 AEs per 100 days hospitalisation). 42.8% of AEs were classified as avoidable. 37.4% of AEs were related to medication, 25.3% to nosocomial infection and 25.0% to technical problems during a procedure.

    In 22.2% of patients in whom an AE was detected, the AE led to readmission. Patients over the age of 65 with extrinsic risks presented an AE incidence 2.5 times higher than those without these risks. 31.4% of AEs led to extended hospitalisation.

    A study sponsored by the MHSPE35 examined the level of implementation of the NQFs recommendations for improving patient safety36 in a sample of 22 SNHS hospitals of different sizes. One finding of this study was significant variation between hospitals in the patient safety parameters analysed. For GAICUs, 80% of the hospitals analysed had no explicit, explained regulations on nursing staffing levels, and only 15% measured the workloads entailed in caring for the specific type of patients cared for. This is an interesting concept on which to base one of the parameters analysed (the existence of regulations on nursing staff levels). Another conclusion of the study, which is relevant to GAICUs, was failures in communication between the various services and professionals involved in care and with patients. The extent to which these procedures were governed by formal protocols was found to be rather deficient.

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    Regarding specific clinical processes, the MHSPEs study on patient safety in SNHS hospitals revealed very uneven levels of regulation and protocol establishment. 90% of hospitals had protocols on handwashing/hand disinfection; 75% had protocols on pressure sore prevention, antibiotic prophylaxis to prevent surgical wound infection and preparation of the skin and mucous membranes for surgery (only 20% stipulated electric hair removal, the recommended procedure); and 70% had protocols on preventing infections associated with central venous catheters. However, there were very few protocols on preventing malnutrition, flu vaccination for staff or preventing lesions associated with ischaemia cuff use. When process indicators were analysed, the risk of pressure sores was assessed in only a third of patients, and the risk of venous or pulmonary thromboembolism was assessed in only 5%. Fewer than 20% of patients received correct assessment to adjust heparin doses.

    Drug management-related issues arising from the study on patient safety in SNHS hospitals are also relevant to GAICUs. Particularly significant is the low level of regulations on drugs with high risks of AEs: no explicit regulations on special labelling and storage for high-risk drugs were found in any hospitals. Most hospitals (except large hospitals) also lacked protocols on the storage and maintenance of first-aid kits on wards. The most common oversights concerned drug stock, a replacement system and the storage of light-sensitive drugs. 55% of hospitals (all medium-sized or small) had no explicit regulations on the storage, preservation or replacement of drugs in the pharmacy unit, and 40% had no explicit procedures for maintaining crash trolleys.

    The data of this study seem to indicate that there is substantial room for improvement in care practices in SNHS hospitals GAICUs.

    2.2.2. The USA

    The Joint Commissions hospital accreditation criteria include requirements relating to the various aspects of the care provided37. While all the issues are interrelated, two of the chapters most closely related to the operation of GAICUs are probably those entitled Nursing; Provision of Care, Treatment and Services; and the National Patient Safety Goals (NPSGs) that apply to hospital care. According to the standards established, the executive head of nursing meets the following criteria:

    Directs the provision of nursing care, treatment and services Holds postgraduate university qualifications and has management

    experience Directs the hospitals nursing services

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    Establishes guidelines for the provision of nursing care, treatment and services

    Directs the implementation of human resources policies, procedures, standards and plans for nursing

    The Joint Commissions standards address the various stages of the provision of care, treatment and services (admission and planning, care, discharge or transfer). They affect all aspects of care, including accommodation and catering, and in a way that is very relevant to the work of doctors and nurses, who must work together:

    Patient admission for care, treatment or services Patient assessment and reassessment Planning of patient care Provision of care, treatment and services to patients Coordination of care, treatment and services Patient education Planning of surgery or other high-risk procedures, including those

    requiring moderate or heavy sedation Care for patients whose mobility must be restricted Care for patients whose mobility must be restricted for reasons of

    mental health Meeting patients needs via continuing care, treatment and services

    following discharge or transfer The NPSGs most closely related to GAICUs activities are the

    following: Improve the accuracy of patient identification Improve the effectiveness of communication among caregivers Improve the safety of using medications Reduce the risk of health care-associated infections Accurately and completely reconcile medications across the conti

    nuum of care Reduce the risk of patient harm resulting from falls Reduce the risk of influenza or pneumococcal disease in institutio

    nalized older adults Encourage patients active involvement in their own care as a

    patient safety strategy The organization identifies safety risks inherent in its patient popu

    lation Improve recognition and response to changes in a patients condi

    tion Apply the Universal Protocol (conducting a pre-procedure verifica

    tion process, marking the procedure site, performing a time-out)

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    Preventing pressure sores associated with care has been removed as a goal that applies to hospitals, probably because it can be an ambiguous variable if not adjusted for the presence of pressure sores prior to admission38.

    In 2002 the Joint Commission published a white paper39 based on the evidence available on the relationship between patient safety and nursing care, including suitable nursing staff levels.

    The Institute for Healthcare Improvement (IHI), in conjunction with the Robert Wood Johnson Foundation, has developed an initiative to improve the clinical management and organisation of GAICUs in US hospitals (10), via the project Transforming Care at the Bedside40 . This has four main categories: safe and reliable care, vitality and teamwork, patientcentred care, value-added care processes.

    The IHI believes that the following goals can be met in GAICUs by working on all four of these areas simultaneously:

    Adverse events are reduced to 1 (or less) per 1,000 patient days 25% reduction in deaths on the TCAB unit 95% compliance with all key clinical process measures (all-or

    nothing measure) for the three top clinical conditions on the TCAB unit

    95% of clinicians, students, and staff say,I work within a supportive environment that nurtures my professional formation and development

    95% of patients are willing to recommend and are satisfied with physical comfort, emotional support, and respect for their values and preferences

    Clinicians spend 70% of their time in direct patient care Clinicians spend 90% of their time in value-added activities

    As part of this strategy, the IHI recommends multidisciplinary visits to the unit. These have been shown to reduce the average length of hospital stays41

    and improve communication and job satisfaction42. Another measure promoted by the IHI is the use of rapid-response teams (11), partly on the basis of the experience of medical emergency teams (begun in Australia)43. The AHRQ suggests a more cautious approach, more heavily based on contrasted scientific evidence, to recommending the use of rapid-response systems (12).

    (10) http://www.ihi.org/IHI/Topics/ReducingMortality/. Consulted on 05/01/2009. (11) This subject is also addressed in the document Intensive Care Unit: Standards and Recommendations. (12) Consulted at http://psnet.ahrq.gov/primer.aspx?primerID=4 on 19/12/2008.

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    In 2004 the NQF approved a series of voluntary national standards for nursing care44 (13).

    Below we have selected those of the recommendations proposed by the IoM25 for nursing that are relevant to GAICUs:

    Hospitals should employ nurse staffing practices that identify needed nurse staffing for each patient care unit per shift (14).

    Hospitals should perform ongoing evaluation of the effectiveness of their nurse staffing practices with respect to patient safety.

    Hospitals must increase external oversight of their staffing methods, levels, and effects on patient safety whenever the number of hours of qualified nursing staff per patient per day in ICUs is less than 12.

    The IoM highlights works that associate suitable levels with greater patient safety, although it does not recommend nursing staff standards in GAICUs.

    Medical institutions should dedicate budgetary resources equal to a defined percentage of nursing payroll to support nursing staff in their ongoing acquisition and maintenance of knowledge and skills.

    Hospitals should take action to support interdisciplinary collaboration by adopting such interdisciplinary practice mechanisms as interdisciplinary rounds, and by providing ongoing formal education and training in interdisciplinary collaboration.

    In 2003 the State of California established a standard of one nurse for every six GAICU patients. In 2001 Kaiser Permanente, a health maintenance organisation with high quality standards and a famously low average length of stay per process45,46 in acute care hospitals, adopted a standard of one nurse for every four GAICU patients. Regulations similar to those of California have been approved in Oregon, Michigan and other states (15).

    The American Association of Critical-Care Nurses has approved a set of standards for nursing practice in acute and critical care (16).

    (13) http://www.qualityforum.org/nursing/#measures. Consulted on 12/01/2009. (14) The IoM emphasises that the use of patient classification systems entails some problems and proposes other methods of sizing workforces in order to compensate for them. (15) Reference taken from the Joint Commission (2002). (16) http://www.aacn.org/WD/Practice/Content/standards.for.acute.and.ccnursing.practice. pcms?menu=Practice. Consulted on 15/12/2008.

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    2.2.3. The UK

    In 1997, the UKs NHS published Health Building Note 4 on In-patient Accommodation. This was essentially focused on aspects of the design and facilities of GAICUs47. There are other NHS Estates publications that refer to GAICUs48,49,50.

    The findings of a 2003 evaluation of bed management in NHS acute care hospitals by the Audit Commission51 included the following:

    81% of patients requiring emergency admission are admitted within four hours of arrival, but in 20% of hospitals patients were admitted to an inappropriate unit. Hospitals have developed alternatives to A&E units for the admission of emergency patients, such as A&E unit observation rooms, other emergency areas and GAICUs in coordination with primary care physicians (17).

    1. The average occupancy index was 95%, which is considered very high.

    2. Only 1.4% (median) of scheduled operations were cancelled due to a lack of available beds.

    3. The estimated number of beds that could be made available through greater use of MOS was also very low (0.69%). However, if the average length of stay for major operations involving conventional hospital admission were the same as in the 25 most efficient hospitals, the median number of bed days saved was estimated at 12.4%.

    4. 75% of patients admitted as emergencies use 35% of bed days. 3.35% of patients with hospital stays longer than 56 days occupy 25% of bed days.

    5. Patients admitted on Thursdays had an average length of stay almost 1 day longer than those admitted on Sundays. The most likely explanation for this is the lower availability of diagnostic resources and medical staff at weekends.

    6. It was estimated that 5% of beds were occupied by patients whose transfers were delayed due to a lack of alternative social or extended care resources.

    A report by the National Patient Safety Agency (NPSA) on AEs reported in the NHS in England and Wales in patients with acute illnesses52

    highlighted two aspects of care: prompt recognition of deterioration in

    (17) A similar mechanism to that advocated in Units for Patients with Multiple Chronic Conditions: Standards and Recommendations, QA, SNHS, Ministry for Health, Social Policy and Equality, 2009.

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    clinical condition and resuscitation. The NPSAs recommendations on early recognition of deterioration in clinical condition are as follows:

    Improving the identification of patients who are at risk, or who have clinically deteriorated53

    Appropriate monitoring of vital signs Accurate interpretation of clinical findings Calling for help early enough and ensuring that help is forthcoming Training and skills development Ensuring that appropriate equipment and drugs are available

    These recommendations are part of the NHSs strategy for introducing extended critical care units in hospitals, with a more holistic vision of care for patients at risk of deterioration outside ICUs and high-dependency units: critical care outreach5,54,55,56,57(18) as part of a more global understanding of care for inpatients58 and following the trends of track and trigger warning systems and rapid-response teams.The recommendations of the National Confidential Enquiry into Patient Outcome and Death point in the same direction59. A recent Cochrane review did not find sufficient evidence on the efficacy of extended critical care in preventing ICU admission or death in conventional inpatient units60(19).

    The NPSAs recommendations on cardiopulmonary resuscitation61(20) are as follows:

    Improving communication Better situation analysis Regularly risk assessing resuscitation processes locally Training and skills development

    (18) Extended critical care unit. (19) This subject is addressed in the Standards and Recommendations document for Intensive Care Units. (20) Soar J, Spearpoint K: In-hospital resuscitation. In: Resuscitation Guidelines 2005, Resuscitation Council (UK), available at: www.resus.org.uk/pages/guide.htm. Consulted on 12/01/2009.

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    3. Patients rights and guarantees

    Hospitals with GAICUs must observe and respect patients rights as stated in current healthcare law. This chapter covers in considerable detail issues relating to the information provided to patients of these units and their families/carers, and gives an overview of other issues which are included in regulations and must be borne in mind in GAICUs or hospitals in which they are located.

    3.1. Information for patients, informed consent

    Involving patients in their own healthcare is an important aspect of all care strategies. As a general principle, information must therefore be clear, accurate and sufficient.

    Information provided to patients in GAICUs must cover the following issues: the general nature of the GAICU; detailed information on the process, treatment and care in the GAICU; informed consent, in the cases stipulated by law (21); instructions and recommendations; care for carers.

    3.1.1. General information on GAICUs

    It is recommended that information provided on admission (e.g. leaflet, brochure) should include at least a description of the GAICU, as well as specific warnings or advice on accessing or using it. Including photographs of the GAICU and its resources may make it easier to understand how it operates.

    Structured information must be provided on the conditions surrounding patients stays in the various sections of the GAICU: timetables, rules for visitors, use of the waiting room, use of the telephone, whether meals can be chosen, mealtimes, use of the television, etc.

    (21) This must be provided in writing in the following cases: surgery, invasive diagnostic and therapeutic procedures and in general procedures that entail risks or discomforts with a clear, foreseeable negative impact on the patients health. Art. 8.2. of Law 88/2002 of 14th November 2002, the basic law governing patient autonomy, rights and obligations regarding medical information and documents.

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    3.1.2. Information on processes, treatment and care in GAICUs

    Information provided to patients should include the following:

    Basic information on the processes which have led to the patients GAICU admission

    Basic information on the treatment and care procedures provided at the GAICU

    Staff must inform the patient and carer of the steps to be taken on the basis of the treatment and care plan.

    3.1.3. Informed consent

    According to applicable legislation, invasive diagnostic and therapeutic procedures and treatments that entail risks or discomforts with a clear, foreseeable negative impact on the patients health may not be carried out without the patients written consent.

    There should be a specimen informed consent form containing specific information

    on each diagnostic or therapeutic procedure of this nature in the GAICUs service

    portfolio.

    When any procedure that entails a certain level of risk is performed, enough information must be provided for the patient and his/her family/carer to be aware of these risks and of the consequences of not taking them.

    Informed consent is governed by Spanish Law 41/2002 of 14th November 2002. This is the basic law governing patient autonomy, rights and obligations regarding medical information and documents. It defines informed consent as free, voluntary, conscious consent granted by a patient in full use of his/her faculties, after receiving appropriate information, for an action affecting his/her health. Every hospital must draw up a separate informed consent document for each clinical activity and specialist area.

    Informed consent must include issues relating to the procedure to be performed, including at least the following information sections (22): the names of the patient, the doctor indicating and requesting consent, and the medical services that will perform it; the name, description and aims of the

    (22) Catalan Bioethics Committee: Guide to Informed Consent, October 2002.

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    diagnostic or therapeutic procedure; general risks and specific risks for the individual patient; the expected benefits and diagnostic/therapeutic alternatives; information on the right to accept or refuse what is being proposed and to revoke consent once it has been granted, and information on the right to state the limits the patient considers appropriate; confidentiality and use of data; date of consent; a separate section for the consent of the patients legal representative; declarations and signatures (patients and doctors).

    The document must be issued in duplicate (one copy for the patient/legal representative and the other for medical records). The patient must be given access to a doctor to clarify any doubts or provide additional information.

    If a procedure requires any type of anaesthetic, informed consent must also be obtained for the anaesthetic technique, following assessment of the risk of anaesthetic and after the patient has been informed clearly about anaesthesia.

    The NQF recommends asking each patient or legal representative to explain in his/her own words the key information on the procedures or treatments for which consent is being requested62.

    In Spain, healthcare declarations (also called advance directives) are governed by the law on patient autonomy. This defines a healthcare declaration as a document in which a legal adult states his/her wishes in advance so that they can be implemented when situations occur which make it impossible for him/her to express his/her opinion or preference on his/her healthcare and treatment personally63(23).

    For patients whose life expectancy is less than six months there must be advanced care plans so that their care is consistent with their values and preferences at more advanced stages of illnessl64,65.

    The Standards and Recommendations document for palliative care units contains more detailed information on healthcare declarations and advance planning for patients with advanced terminal diseases66.

    3.2. Care for carers

    Families and partners take on an additional role as carers. Active, informed involvement of carers is essential to the progress of many of the patients cared for in GAICUs. They must therefore be given training and

    (23) Article 11: Healthcare Declarations of Law 41/2002 of 14th November 2002, the basic law governing patient autonomy, rights and obligations regarding medical information and documents.

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    information. A carer is both a resource that provides patient care and a client of the GAICU.

    The main carer of a chronic patient is the person who usually cares for someone who is ill or has a physical or mental disability and so cannot care for him-/herself. This is the difference between the main carer and other carers who provide occasional or intermittent care.

    Work with carers must not be restricted to informational and training activities regarding patient care. It must also cover issues relating to care for carers themselves, addressing their problems and preventing abnormal situations.

    Care for carers is provided both within and outside hospitals (at patients homes or health centres). The Standards and Recommendations documents for pressure sores17 and palliative care units66 provide more information on care for carers.

    3.3. Guarantees of patients rights

    In addition to the more specific documents and procedures stated in section 3.1, hospitals must also have the following:

    a) Service portfolio b) Admission plan c) Code of ethics d) Clinical practice and care guidelines, pathways or protocols e) Written clinical trial procedures f) Medical records g) Procedure for healthcare declarations h) Discharge and nursing reports i) Protocols guaranteeing the security and confidentiality of and

    legal access to patient data j) Complaints and suggestions book k) Insurance policy

    The right of patients or their families or loved ones to access these documents must be guaranteed, in the terms stated in current law, with the exception of those stated in points d), e) and i).

    Some issues relating to these rights are examined below, with particular reference to GAICUs. Points a) Service portfolio and f) Medical records are included in Chapter 5 of this document, Organisation and Management.

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    3.3.1. Admission plan

    Hospitals must have admission plans for patients who are admitted. GAICUs may have admission plans for their own patients, providing the general information indicated in sections 3.1.1 and 3.1.2 and in the above list of patients rights and obligations.

    3.3.2. Code of ethics

    Hospitals must have codes of ethics stating the ethical principles and guidelines by which their activities will be governed.

    3.3.3. Clinical practice guidelines

    Like other hospital units, GAICUs must have reliably-documented evidence of the clinical practice and care guidelines, pathways or protocols they apply for each item stated in their service portfolios, along with assessments of these and any alterations or adaptations.

    3.3.4. Clinical trial procedures

    Clinical trial conduct must comply with the conditions and guarantees established in specific legislation on the subject.

    3.3.5. Price list

    Hospitals must have price lists available to users. These must be submitted to the relevant authority in accordance with specific regulations on the subject.

    3.3.6. Complaints and suggestions

    Hospitals must make complaints and suggestions forms available to their users. These must allow users to state their complaints, claims, ideas and suggestions regarding the operation of the unit, as they feel appropriate.

    The availability of these forms must be clearly indicated. Their location must be as accessible as possible, so that they can be identified and used. GAICUs must provide inpatients and those accompanying them with access to the complaints procedure.

    Users of the hospital are entitled to a written reply from the head of the centre or another authorised person to complaints or claims they

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    submit. This does not affect referral to the relevant authorities, as established in the law of the autonomous region in question.

    Complaints, claims, ideas and suggestions must be evaluated regularly.

    3.3.7. Liability insurance

    Healthcare professionals who work in private healthcare, and privatelyowned legal entities or bodies providing healthcare services of any kind, are required to hold a liability insurance policy, guarantee or other financial provision to cover claims which may arise as a result of any harm caused to individuals by the provision of such care or services.

    Hospitals must have liability insurance policies which are appropriate for the activities they perform, in order to deal with possible claims for compensation for harm to patients to which they must respond.

    3.3.8. Filing policies

    Hospitals and any freelance healthcare professionals must keep a copy of documents providing evidence of the liability guarantees required of them.

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    4. Patient safety(24)

    The medical advances of the twentieth century altered the prognosis and treatment of many diseases. However, this development has been accompanied by an increase in the complexity, specialisation and segmentation of healthcare, which have led to a rise in risk and potential unnecessary harm to patients. Healthcare entails risks of substantial harm to patients and high costs to medical institutions and society. According to studies conducted in the USA67, both hospital admission and exposure to medicines in hospitals are associated with higher mortality levels than those attributed to firearms or road accidents.

    Mistakes in healthcare (system errors) have serious consequences for patients and families, generate very high healthcare and financial costs, weaken patients trust in the system and harm medical institutions and staff, who are undoubtedly their second victims. Patient safety, understood as minimising the risk of harm associated with healthcare (International Classification for Patient Safety: WHO, June 2007) is therefore a priority nowadays for the main health organisations such as the World Health Organization68, international institutions such as the EU69 and the Council of Europe70, healthcare authorities, professional associations and patients organisations.

    The MHSPE placed patient safety at the centre of healthcare policy, as part of its responsibility to improve the quality of the health service as a whole in accordance with Spanish Law 16/2003 on cohesion and quality in the SNHS (25). This is reflected in Strategy 8 of the QP, SNHS13, which aims to improve the safety of patients cared for at SNHS medical institutions in various ways, including promoting and developing an awareness and culture of patient safety among staff and patients (and stimulating training and research in this field); designing and implementing information and AE reporting systems for training purposes; involving the public; and implementing recommended safe practices that are supported by evidence available in SNHS establishments. This strategy is based on recommendations of the WHO and other international institutions71.

    This chapter includes some recommendations and practices aimed at improving patients safety during their stay at GAICUs and when they are transferred to other medical units.

    (24) This chapter is based on the corresponding chapter of Unit for Patients with Multiple Chronic Conditions: Standards and Recommendations, MHSPE, 2009. (25) Law 16/2003 of 28th May 2003 on cohesion and quality in the SNHS, Official State Gazette issue 128 (29th May 2003).

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    The implementation of some of the practices included here is still at a very early stage in Spain. These are state-of-the-art practices proposed in recent years as knowledge in the area of patient safety has increased. They take time to become established because they require far-reaching changes in organisations cultures or involve investment in technology, staff and training72. The inclusion of safe practices in these standards for GAICUs may contribute to their implementation.

    It should be noted that the implementation of some of these basic practices for patient safety, such as the availability of electronic medical records or electronic prescriptions, are therefore not covered in this chapter because they depend on the policies of regional governments or the medical institutions in which GAICUs are located and are not specific to GAICUs themselves.

    The NQF recently published an update of safe practices for better healthcare62. Most of the thirty-four safety measures recommended by the NQF apply to GAICUs. These include:

    Informed consent: covered in point 3.1.3. Life-sustaining treatment: ensure that written documentation of the

    patients preferences for life-sustaining treatments is prominently displayed in his or her chart.

    Disclosure: following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event.

    Care of the caregiver: following serious unintentional harm due to systems failures and/or err