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Ins Palanca Snchez. Health Planning and Quality Office. QA-NHS. MSPSI Technical
and Institutional Directorate.
Alfonso Castro Beiras. Scientific Co-manager. Head of the Cardiology Service of the Uni
versity Hospital Complex A Corua. Co-ordinator of the National Healthcare System
Ischemic Cardio-pathology Strategy.
Carlos Macaya Miguel. Scientific Co-manager. Head of the Cardiology Service, San Car
los Clinical Hospital. President of the Spanish Society of Cardiology (Sociedad Espaola
de Cardiologa)
Javier Elola Somoza. Technical Manager. Elola Consultores S.L.
Editorial board
Group of Experts
Mara del Carmen lvarez Gonzlez. Health Planning and Quality Office. QA-NHS.
MSPSI.
Virgina Argibay Pytlik. Head of the Spanish Society of Nursing in Cardiology (Asociacin
Espaola de Enfermera en Cardiologa).
Jos Brugada Terradellas. Person responsible for the Cardiac Arrhythmia Unit Hospital
Clinic (Barcelona).
Alfonso Castro Beiras. Head of the Heart Institute at the Juan Canalejo University Hospi
tal (La Corua). Head of the NHS Ischemic Cardio-pathology Strategy.
Jos Mara Cortina Romero. Head of the Cardiovascular Surgery Service. 12 Octubre
Hospital (Madrid).
Carlos Fernndez Palomeque. Head of the Cardiology Section at the Son DuretaUniver
sity Hospital (Palma de Mallorca).
Miguel ngel Garca Fernndez. Full Professor for Cardiology. Complutense University.
Madrid.
Javier Goicolea Ruigmez. Head of the Hemodynamics Service. Puerta de Hierro-Maja
dahonda University Hospital (Madrid). President of the Hemodynamics and Interventio
nist Cardiology Section of the Spanish Society of Cardiology.
Miguel Josa Barca-Tornel. Cardiovascular Surgery at the Clinical Hospital of Barcelona.
Depty President of the Spanish Society for Thoracic and Cardiovascular Surgery (Socie
dad Espaola de Ciruga Torcica y Cardiovascular).
Publishing support
1. Introduction 00
1.1. Document scope 00
2. Situation analysis 00
2.1. Stanards and recommendations 00
its results 00
4. Patient safety 00
4.1. Safety Culture 00
12. Quality 00
Annexes
1. Groups related by diagnosis (GRD) of the cardiology area 00
2. Structural, process and results indicators of the emergency
system for healthcare to patients with acute coronary syndrome 00
3. Treating the patient with congestive heart failure 00
4. Requirements for a Primary Percutaneous Coronary
Intervention system (PCI-P) 00
5. Phases of prevention programs and cardiac rehabilitation 00
6. Agreement of collaboration between the SEC and the SERAM
in the area of cardiology diagnostic imaging 00
7. Office of hemodynamics and intervention. Specifications
of the SEC 00
8. Dimensioning of the CCUs in a regional services network 00
9. Program for specific locales in the Area of the Heart 00
10. Equipment programme 00
11. Advanced training in hemodynamics and interventionism
Criteria by the ESC and the SEC 00
12. Training requirements of a electrophysilogy cardiologist 00
13. List of devices and systems needed in an operating theatre
of cardiovascular surgery 00
14. Structural resources, systems and devices needed at the
post-operative intensive care unit of cardiovascular surgery 00
15. Specific needs of the hospitalization room for cardiovascular
surgery 00
16. Alphabetical index of definitions and terms of reference 00
17. Abbreviations and acronyms 00
18. Bibliography 00
Diagrams
5.1. Relationship between processes and healthcare units 00
5.2. Clinical pathway of congestive heart failure (CHF) 00
5.3. Clinical pathway for acute coronary syndrome (ACS) 00
5.4. Clinical pathway for acute coronary syndrome (ACS) 00
5.5. Clinical pathway for acute coronary syndrome (ACS) 00
5.6. Clinical pathway for syncope 00
8.1. Patient journey after catheterization 00
A.3.1. Ranking of chronic patients 00
A.5.1. Phase I: Hospital 00
A.5.2. Phase II: Ambulatory 00
A.5.3. Phase III: Maintenance 00
Pictures
6.1. Critical care unit: doctor's room 00
6.2. Critical care unit: patient's room 00
6.3. Cardiovascular critical care unit: patients box 00
6.4. Room for cardiac rehabilitation 00
6.5. Room for cardiac rehabilitation (detailed) 00
6.6. Cardiac rehabilitation consultation 00
7.1. PET-CT room from the control post 00
7.2. Gamma-camera 00
7.3. MR from the control post 00
7.4. MR 00
7.5. Room for Diagnostic Imagery reports 00
The Law 16/2003, of May 28th, on cohesion and quality of the NHS, estab
lishes, in its Articles 27, 28 and 29, the need to establish safety and quality
guarantees that shall be requested for the regulation and authorization by the
Autonomous Regions for the opening and initial functioning of the respective
territorial area of the centres, services and healthcare establishments.
The Quality Plan for the NHS (QP-NHS) includes the strategy for
sanctioning and auditing centres, services and healthcare units, having as its
first objective the establishment of the basic common requirements and the
safety and quality guarantees that shall be fulfilled for the opening and
functioning of the healthcare centres of the NHS.
From the year 2007, in which the Ministry of Health and Consumers
(MSC) reviewed the guide of Major Ambulatory1 Surgery published in
19932, documents have been elaborated concerning the standards and rec
ommendations for the unit of medical and onco-hemotologicalhospitaliza
tion3, the unit for multi-pathology4 patients, maternity hospitalization5, the
surgical unit6, the unit for palliative care7, the nursing unit for multi-service
hospitalization of acute patients8, the units for hospital emergencies9 and
the unit for intensive care10.
Besides, the Ministry for Health, Social Policy and Gender Equality
(MSPSI) has a strategy for ischemic coronary pathology of the National
Healthcare System (ECI-SNS)11, and its updating has been approved by the
NHS Inter-territorial Council in 200912. This fact, together with the inci
dence and prevalence of cardiovascular illnesses in Spain, has made that the
NHS Agency of Quality (AC-SNS) to begin the drafting of the standards
and recommendations for healthcare units linked to the cardiology area, in
collaboration with scientific societies of cardiology, cardiovascular surgery
and nursing in cardiology.
(1)
Source: INE (http://www.ine.es). Defunciones segn causa de muerte. 2007. Own creationpia.
(2)
Source: INE (http://www.ine.es). Encuesta de morbilidad hospitalaria. 2007. Own creation.
(3)
Source: MSPS (http://pestadistico.msc.es). Spanish National Healthcare System. 2006. Register of
the NHS hospital discharges. CMBD. Own creation.
(4)
19% said to have hypertension, 6% diabetes and 14% high cholesterol (multiple answer).
(5)
The classification of healthcare centres, services and premises was revised, in turn, by the Minis
terial Order 1741/2006.
(6)
http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm.
(7)
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Own creation.
(8)
http://www.msc.es/profesionales/hcdsns/areaRecursosSem/snomed-ct/snomedHCD.htm.
(9)
The following is an adaptation to the ECI-NHSs technical recommendations with regards to the
stable angina, to extend them to all the circulatory system diseases.
(10)
Pathologies, techniques or diagnostic or therapeutic procedures for which designation of
RCSU-NHS is necessary. Area of Cardiology and Cardiac Surgery. Agreement of the NHS
Inter-territorial Council at its meeting of 22nd October 2009.
(11)
Resolution, of 24th July 2003, of the DG for Process Organization and Training, laying
down the quality authorization system for healthcare centres and units of the Andalusian
Public Healthcare System, in accordance with the quality model of the Andalusian healthcare
system.
CCU Guides
The MSPSI as well as the Autonomous Regions have drafted guides for
some units, which, without having a normative character, pursue standardi
zation and establish recommendations on quality and safety. There is no
precedent in the MSPSI or in the former INSALUD of drafting of guides
on CCUs. The ECI-SNS, focused on healthcare processes, proposes some
quality standards related to the CCU organization and management in the
NHS. The guides published by the Autonomous Regions are focused on
healthcare processes. They do not specifically develop those related to plan
ning, design, organization and management of the CCUs, although some
quality standards effect them.
Andalusia has drafted the Integral Plan of Cardiac Pathologies Treatment22
and Integrated Healthcare Processes corresponding to stable angina23, thoracic
pain24, acute myocardial infarction25, acute coronary syndrome without ST ele
vation26, acute aortic syndrome27 and pulmonary thrombi-embolism28.
The Principality of Asturias has developed a guide of clinical recom
mendation about ischemic cardiac disease29, which focused more on clinical
aspects than on those relative to organization and management.
Galicia has developed the Galician programme for the treatment of
acute myocardial infarction30 with a similar focus as the one of the guides
of Andalusia and Asturias.
(12)
Catalonian Government Decree 5/2006, of 17th January..
(13)
Galicia. Decree 52/2001 of 22nd February.
(14 )
Extremadura. Decree 227/2005 of 27th September. Order 18th July of 2006.
(15)
Source: MSPS (http://pestadistico.msc.es). Causas de muerte CIE. 2007. Regarding the
group of diseases of the circulatory system, the ones excluded in Table 1.1 have been elimina
ted.
(16)
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Own creation..
(17)
Source: MSPS (http://pestadistico.msc.es). Spanish national survey on healthcare 2006.
19% said to have hypertension, 6% diabetes and 14% high cholesterol (multiple answer).
(18)
The EESCRI holds 196,583 studies; so we can assume that the SEC's register contains all
the hemodynamics units. The SEC's register points out the activity of 99% of those centres
carrying out interventional therapies in Spain. However, there are important differences bet
ween both sources with regard to the number of rooms registered: 218 (EESCRI) or 173
(SEC). This difference affects the calculation of performance per room, but not the rate of stu
dies per population. The performance calculation have been made with the EESCRI's data.
(19)
www.secardiologia.es
(20)
www.sectcv.es
(21)
The SECTCV points out that the data reported on mortality for each variable or category
are not always complete. That is why they do not include the real mortality, corresponding to
all the services. Therefore, each mortality percentage that appears there must be interpreted
carefully, only as an indicative figure. In order to be able to compare data with other registers,
it is not mention if the mortality reported took place in a hospital or, as in the British register,
if it was 30 days after the surgical intervention.
(22)
www.escardio.org
(23)
Las tasas son estimaciones propias a partir de las cifras proporcionadas por la AHA y la
poblacin estimada por la OCDE en 2006 (298,755 millones de habitantesThe rates are esti
mations from the figures provided by the AHA and the population estimated by the OECD
in 2006 (298.755 million inhabitants).
(24)
www.americanheart.org
(25)
www.acc.org
(26)
Vase: Unidad de urgencias hospitalarias. Estndares y recomendaciones. AC-SNS. MSPSI.
2010.
United Kingdom
The United Kingdom has developed the ischemic heart disease strategy67
within the National Services Framework. The strategy, published in the year
2000, establishes standards for the improvement of care of patients with
ischemic heart disease, as well as the development of a system in health care,
protocols for referral, complementary examinations, treatment and follow
up: In relation to the CCUs, it establishes the following standards:
Coronarography: a minimum of 500 studies a year, per hospital, done
by a minimum of two medical specialists; each specialist shall do a minimum
of 100 cardiac catheterizations a year.
Interventions: percutaneous coronary (PCI) a minimum of 200 proce
dures a year, per hospitals, done by a minimum of two doctor specialists;
each doctor specialist shall do a minimum of 75 angioplasties a year. The
PCI shall only be done with surgical coverage and in hospitals where extra
corporeal circulation and be done in 90 minutes after the decision of surgi
cal referral.. If the surgical service is in another centre, transfer time shall
not exceed 30 minutes.
(27)
www.ahrq.gov
(28)
www.ihi.org/ihi
(29)
As it is widely known, the NHS allows people to access (through Internet) knowledge of the
standardized rates of survival through coronary surgery in NHS hospitals.
(30)
www.nice.org.uk
(31)
www.sign.ac.uk
(32)
www.ncepod.org.uk
The hospital with a CCUs shall observe and respect the rights of the patient
contained in the current healthcare legislation. In this chapter figure aspects
about information to the patient and relatives of this unit and, in general,
those others included in the regulation and that shall be taken into consid
eration in this type of units and, where necessary, in the healthcare centres
whicj they are located..
(33)
It will be provided in written in the following cases: surgical intervention, diagnostic and
invasive therapeutic procedures and, in general, implementation of procedures that imply risks
or inconveniences and foreseeable negative repercussion on the patients health. The informed
consent is regulated by the basic regulating Law 41/2002, of November 14th, on the patients
autonomy, rights and obligations concerning medical information and documentation.
Informed consent
Carrying out of diagnostic and invasive therapeutic procedures, as well as
the administration of treatments implying risks or notorious inconvenienc
es and foreseeable negative repercussion on the patients health, will
require written consent, according to the provisions of thepertinent law.
(34)
Comit de Biotica de Catalua .Gua sobre el consentimiento informado. October 2002..
Terminal situation(35)
In Spain, previous instructions have been regulated in Art.11 of the Law
41/2002, basic regulator of the autonomy of the patient, which define how
the document through which over age people manifest their will before
hand, with the objective of its being carried out in future situations in which
they cannot personally express their preference as to care and treatment of
their health83.
(35)
Check: Unidad de cuidados paliativos. Estndares y recomendaciones. AC-NHS. MSPSI
2009; and related documents of the ECP-NHS. http://www.msc.es/organizacion/sns/planCali
dadSNS/cuidadosPaliativos.htm
(36)
R.D. 1591/2009 of 16th October, regulating medical devices. We understand as medical
device any instruments, appliances, equipment, software, materials or other items, whether used
individually or in combination (together with any software intended by the manufacturer to be
used for specific diagnostic or therapeutic purposes and that contributes to its good function
ing), which are intended to be used for human beings in the: diagnosis, prevention, monitoring,
treatment or alleviation of a disease; diagnosis, monitoring, treatment, alleviation or compen
sation for an injury or deficiency; research, replacement or modification of the anatomy or of
a physiological process; conception regulation; and which does not mainly work inside or on
the body through pharmacological, chemical, immunological or metabolic means, though it
may help to its function by such means.
Reception program
The CCUs will have available a reception plan destined to the in-patient.
Code of ethics
The hospital with a CCUs will have available a code of ethics, in which there
are contained a group of ethical principles and rules which will inspire its
activity.
Responsibility insurance
The health professional who practices in the field of private health health
care, as well as the judicial person or entity of private ownership who offers
any kind of health services, shall have the prescribed responsibility insur
ance, guarantee or other financial guarantee, which covers the compensa
tions which could be derived from eventual harm to persons, caused on
occasion by the practice of said healthcare or services.
The hospital will have available responsibility insurance in accordance
with its activity to cover eventual compensations to which they must
respond for harm to the patient..
Policy files
The centre and, if the case may be, the health professional on his own part,
shall conserve a copy of the documents accrediting demanded responsibili
ty guarantees.
(37)
This section is based on the remarks provided by Dr. Jos Cortina.
(38)
http://www.cardiosource.org/Search.aspx?q=Appropriatness+criteria
(39)
ACR Appropriateness Criteria (www.acr.org/SecondaryMainMenuCategories/quality_
safety/app_criteria.aspx).
(40)
Ley 16/2003, de 28 de mayo, de cohesin y calidad del NHS. BOE n. 128 (29-5-2003).
(41)
The application of this criterion to the Cardiovascular Critical Care Units is done in section
6.1.5.
(42)
This aspect has been widely dealt with in: Bloque Quirrgico. Estndares y recomenda
ciones. AC-SNS. MSPS. 2009.
(43)
This aspect has been widely dealt with in: Bloque Quirrgico. Estndares y recomenda
ciones. QA-NHS. MSPS. 2009.
(44)
RD 1088/2005, laying the technical requirements and the minimal conditions of blood dona
tion and of the transfusion service centres and RD 1301/2006 of November 10. laying the qua
lity and safety regulations which regulates all activities related to the used of human tissue.
(45)
This section is widely based on the one of the same statement, of the document: Bloque
Quirrgico. Estndares y recomendaciones. AC-SNS. MSPSI Madrid. 2009.
(46)
The average aortic-coronary bypass mortality rates in the USA and the United Kingdom
are under 3%.
(47)
This section is partly based on the remarks provided by Dr. Gins Sanz, as well as on the
development of the assistance network concept by the documents editorial board that is
applied to the CCUs.
(48)
The key aspects in relation to the healthcare process considered by the ECI-SNS are the fol
lowing:
Existence of a patients with acute coronary syndrome classification system, according to seri
ousness and a 12 derivation electro-cardiogram and initial stratification performance, if possi
ble within the first 10 minutes.Time for revascularization with fibrinolitics in less than 30 min
utes (time door-needle) or 90 minutes (time call-needle) or primary angioplasty in less than 90
minutes (time door- bag).Coronarography performance, with a view to revascularization, with
in a period of maximum 3 months from its indication. In case of needing a revascularization,
this will be done through surgical coronary or percutaneous interventions. The coronarography
and revascularization on patients with left ventricle ischemic systolic dysfunction, when it is
considered indicated, will follow the same steps..
(49)
The definition has relevance to the reimbursement activity system. The publication of the
NQF, accessible on internet, does not allow its quotation.
(50)
Conditions, techniques, technologies or diagnostic or therapeutic procedures for which it is
necessary to designate RCSU-NHS. rea de cardiologa y ciruga cardiaca (Area of Cardiol
ogy and Cardiac Surgery).
(51)
ECI-SNS, figure 3.4. of presentation and clinical assessment of patients; and figure 3.5 of
risk stratification.
(52)
The ECI-SNS points out that primary angioplasty as initial treatment for myocardial infar
tion requires the establishment of a network of tertiary hospitals that can perform continuous
angioplasties and of another network for patient transfer from the patients residence, primary
healthcare centre or local hospital with skilled staff and external defibrillator. There shall be
agreed protocols of transfers between hospital, reference centres and transfer systems (emer
gency) to avoid unnecessary wait. The emergency integral system for acute coronary syndrome
shall develop the healthcare network, based on regional planning, that includes,where possi
ble, transfer systems to the CCUs in which it is possible to perform a primary angioplasty in
less than 90 minutes (door-balloon).
(53)
Conditions, techniques, technologies or diagnostic or therapeutic procedures for which it is
necessary to designate RCSU-NHS. rea de cardiologa y ciruga cardiaca (Area of Cardiol
ogy and Cardiac Surgery). Agreement of CI-SNS, 10-22-2009. Ciruga reparadora compleja de
la vlvula mitral (Complex reconstructive surgery of the mitral valve).
(54)
Conditions, techniques, technologies or diagnostic or therapeutic procedures for which it is
necessary to designate RCSU-NHS. rea de cardiologa y ciruga cardiaca (Area of Cardiol
ogy and Cardiac Surgery). Agreement of CI-SNS, 10-22-2009. Integral healthcare in adult with
congenital cardiopathy and family cardiopathy (it includes hypertrophic myocardiopathy).
(55)
RD 365/2009, of 20th March, whereby the minimum conditions and requirements on safety
and quality in the use of automatic and semi automatic external defibrillators are established
outside the medical field.
(56)
The Wright and cols criteria. (The Society of Cardiothoracic Surgeons and The British Car
diac Society, 2002) take efficiency elements into account; such as the necessity to maintain an
on-call service located as a rotation system of 1 out of 5 days. A number of 6 surgeons and
1.200 major interventions is considered the minimum viable for the unit..
(57)
In the chapter size and performance requirements for each unit are developed.
In Attachment 4 Implantation Criteria For A Primary Angioplasty Network, Adapted To The Program
(58)
For example: Royal Decree 71/208, of 23rd June, regulating the operation of the Heart Clin
ical Area (BON of 23rd July 2008).
(59)
For instance, if it refers to circulatory system diseases, including the cerebrovascular and
peripheral vascular ones.
(60)
The care of acute coronary syndrome would benefit, in those geographical areas where pos
sible, from a concentration of on-call laboratories (24*7*365) where primary angioplasty can
be executed in centres with a population coverage of 1.2 millions inhabitants (PCI) and hav
ing cardiovascular surgery (or would be able to transport it in < 30 minutes).
(61)
In the development of these communications systems, the fulfilment of the confidentiality
and privacy requirements laid down by the Organic Law 15/1999, of 13th December, on Per
sonal Data Protection shall be taken into account.
Hospital emergencies
The relation between the CCUs and the emergency ward service is modified
with the development of an integral emergency system and a model of syste
matic care to chronic complex patients, reducing the delay of care and the
unnecessary demand for emergency services by consequence or spontane
ous access of the patient. (Annex 3)The development of an integral system
of emergency services (for example, for the care of severe coronary syndro
me with ST elevation) needs protocols from the CCUs and the heart failu
re unit for fast track procedures that avoid delays, which might harm the
patient, in the emergency services unit.
Conventional hospitalization
Conventional hospitalisation occurs within a nursing unit of multipurpose
hospitalisation of chronic patients (INU) (UEH in Spanish) that is defined
asan organization of healthcare professionals who offer multidisciplinary
healthcare in a specific area of the hospital, that guarantees the care of hos
pitalised patients, doctor or surgeon, severe or chronic patients made more
acute who do not require advanced or basic respiratory support nor support
one or more organs or systems and fulfil some functional, structural and
organizational requirements and guarantees appropriate quality, safety and
efficiency conditions. The hospitalisation unit is like an intermediary unit
(62)
The residents of 4th and 5th year would stand for 50% of full-time. The ratio 1:10 has been
calculated for an average stay of 5 days, in case of a longer stay it will tend to 1:12.
Error! Marcador
The BCS establish standards for the Coronary Care Unit
no definido
which figure in table 6.1.
Picture 6.2. Cardiological critical care unit. Picture 6.3. Critical care unit.
Cardiovascular nurse station: patient stallSurgical unitFoto
Surgical unit
The operating theatres or surgical sessions dedicated to cardiovascular sur
gery will depend on the volume of cases dealt with and share the same cha-
(63)
Adapted from: Health Building Note 28. Facilities for cardiac services. DH States and Faci
lities Division. 2006.
Electrocardiography (ECG)
The ECG must be considered as a basic test for many patients. The current
digitalisation of the registries facilitates the strategy of centralised local
positions for the registry of technology (for example in the areas of analyti
cal extraction) that allow the general patient to be referred to strictly the
cardiological healthcare circuit and get this type of systematic tasks to spe
cialised unit staff.
There must be quality ECG equipment in the unit. Every stall must be
able to accommodate the patient, whether in a wheel chair or on a stretcher,
and their companion, to the aide who carries out the ECG and occasionally
a cardiologist.
The stall must have space for electrocardiographic equipment moun
ted on a trolley. The stall must also have an adjustable seat that allows access
Stress test176
The box for stress tests shall be wide enough to accommodate the necessary
equipment, including emergency and defibrillator equipment. Each box
shall accommodate the patient and the person accompanying him, the nur
ses aide and the nurse who is doing the test and occasionally the cardiolo
gist and shall permit the circulation and access to the patient in emergency
situations. The rate of grave complications (heart failure or any grave com
plication which required the admission to the hospital) is esteemed at
1/10.000 tests. Room shall be set aside for electrocardiograph equipment
mounted on a cart, a treadmill or exercise bicycle which permits access to all
sides, a sphygmomanometer, a computer terminal for the aide and shelves
with pharmacological stress drugs.
The box shall have good lighting and be well ventilated, with a tempe
rature (20-22C) and humidity (around 50%) control. It is very useful to
have a wall clock with second hand or a digital one. The examination area
shall have enough space for towels, a bucket and other elements needed for
the preparation and test. A curtain for the patients privacy during the pre
paration is useful. To evaluate the level a stress to be applied, a perceived
stress scale shall be placed on the wall and in view of the patient. In labora
tories where gas exchanges are performed there shall also be a thermome
ter, a barometer and a hygrometer.
A system for electrocardiograph registration for continuous monito
ring of the cardiac rhythm and evaluation of ischemic electrocardiograph
changes during the exercise shall be set up. The equipment varies from com
puterized to conventional systems.The monitoring of arterial pressure. The
manual taking of arterial pressure is still the most practical and simple
method for the control of arterial pressure. Cuffs of various sizes, including
large and paediatric, shall be on hand. Mercury manometers have been
replaced with digital or aneroid ones for environmental safety reasons. To
carry out an ergometry test a treadmill or bicycle are used. It shall be elec
trical and allow more than 157.5 Kg. The treadmill shall move electrically
and permit weights of 157.5 Kg. It shall have a range of speeds from 2 K/hr
to, at least, 12 k/hr, and with a inclination which varies from 0 to 20%.
179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,
195,196,197,198,199,200,201,202,203,204,205,206,207,208
(64)
This charpter is based on the contributions, made for this documents on standards and rec
ommendations, by Eva Laraudogoitia Zaldumbide, Miguel ngel Garca- Fernndez, Jos
Juan Gmez de Diego and Ro Aguilar Torres, as well as comments and suggestions by the
Spanish Society of Medical Radiology (SERAM) and PHILIPS and Siemmens. (companies).
(65)
Depending on the services portfolio of the coronary area (population range).
Equipment
High specialization of echocardiography imaging of the heart, since it has to
do with viscera which is moving, makes for the services and equipment
adjustments to be completely adapted and valid.
A summary of the minimum requirements which are considered at
present to be acceptable for echocardiography equipment, in accordance
with the norms for accreditation of echocardiography offices and the rec
ommendation for the performance, digitalization, storage and reporting of
echocardiography studies of the EAE are summarized in the following
points:
The systems shall be specifically configured for cardiac applications
with the adaptation of software and adequate probes. They shall per
mit high quality images to be obtained, especially the availability of
a harmonic image, with high temporal-space resolution and a high
depth of the scale of greys.
The complete capacity to perform Doppler studies in all its modali
ties, including continuous, pulsed means, Colour Doppler and tissue
Doppler (colour and pulsed).
The systems shall be equipped with trans-thoracic phase-array
multi-frequency probes in the range of 2-6 MHz for children and 7
10 MHz for new-borns.
A storage and digital connectivity system.
Multi-frequency multi-plain probes are the present standard for
trans-oesophagus echocardiography.
(66)
Depending on the services portfolio of the coronary area (population range).
Photo 7.1. PET-CT room from the nurse station Photo 7.2. Gamma camera
(67)
This chapter is based on the contributions, given for this document on standards and recom
mendations, by Javier Goicolea, updating the SEC's guide. Mors de la Tassa C (Coord.),
Cequier AR, Moreu J, Prez H, Aguirre JM. Guas de prctica clnica de la Sociedad Espao
la de Cardiologa sobre requerimientos y equipamiento en hemodinmica y cardiologa inter
vencionista. Rev Esp Cardiol 2001; 54: 741-750.
(68)
Hemodinamic specialist: cardiologist with advance training in hemodynamics and interven
tional cardiology.
(69)
Accreditation system for the exercise of hemodynamics and interventional cardiology
aimed at professionals and training units. Hemodynamics and Interventional Cardiology Sec
tion of the Spanish Society of Cardiology. (www.hemodinamica.com).
Satellite unit
Hemodynamics office located in a health centre without cardiovascular sur
gery and in which procedures are performed by hemodynamics experts who
belong to the personnel of the intervention unit of the network.
The procedures excluded from this type of units are seen in chart 8.2.
With exception of the CCV it shall count on the same services and sup
port units as the intervention units, including the cardiology service or
unit.
In the informed consent it should expressly state that, in the case of
urgent surgery, this will be performed in another previously contracted
centre.
The responsibility for functioning of the unit will correspond to the
person responsible for the intervention unit of the network, establis
hing the corresponding agreements with the cardiology service or unit
of the hospital.
(70)
With more than one room, 3 hemodynamic specialist may be enough for every two rooms.
The programming of the estimated complexity must allow it.
(71)
This chapter is based on the contributions, given for this document on standards and recom
mendations, by Josep Brugada and Julin Villacastn, actualizing the corresponding SEC guide:
Brugada J (Coord.), Alzueta FJ, Asso A, Farr J, Olalla JJ, Tercedor L. Guas de prctica clni
ca de la Sociedad Espaola de Cardiologa sobre requerimientos y equipamiento en electrofi
siologa. Rev Esp Cardiol 2001;54:887-891.
Other equipment
Aside from radiological equipment, the electrophysiology laboratory shall
include: a) electric amplifiers, physiological signal registers and adequate
monitors; b) an electric cardiac stimulator; c) radio-frequency generators; d)
a cardiopulmonary reanimation system including an external synchronized
defibrillator with the possibility of administering bi-phase shock; e) a tran
sitory pacemaker battery, f) tri-dimensional mapping systems, g) the avail
ability of an anaesthesia team and, h) non-invasive monitoring systems: Pul
sioximetre and non-invasive TA monitor. According to the specialization of
the laboratory additional equipment can be available such as a crio-ablation
generator, intra-cardiac echo-graph system or robotized equipment for
ablation.
The physiological register (polygraph) has as its purpose the collection
of presentation of electrophysiological data, permitting its analysis, immedi
ately as well as afterwards. The register can include monitoring of vital signs
of the patient during the procedures, The register shall permit the simulta
neous obtaining of various endo-cavity signs, conveniently filtered and
amplified, along with various electro-cardiograph surface referrals. It is
absolutely necessary that it can obtain registrations on paper at different
speeds (25 to 200 mm/s). Ideally the register shall permit the simultaneous
obtaining of the 12 referrals of the surface electro-cardiogram and between
16 and 128 endo-cavity signs.
At the same time, it shall contain the possibility of registering quality
bi-polar and mono-polar signs. The register shall be isolated so that it not
receive interferences with radio-frequency due to the danger of losing the
signs at the moment of applying energy. The new registration equipment are
almost all of them based on digital signs with computerized support which
permit the obtaining of many signs simultaneously, as well as their storage
on optical discs and their laser printing.
The electrical cardiac stimulator shall permit stimulation using a wide
range of frequencies, with the possibility of introducing multiple extra-stim
uli, with programmable and synchronized connections to its own or stimu
lated activity. The intensity and duration of the stimulus shall be program
mable.
(72)
This chapter is based on the contributions, given for this document on standards and recom
mendations, by Joseba Zuazo, Miguel Josa and Jos M Cortina.
Surgical activity
Operating room characteristics of CCV have been made reference to in
chapter 6.
From the beginning of anaesthetic induction until the departure of the
patient from the operating room, a conventional cardiovascular surgical
procedure lasts no less than 4 hours. With the gradual increase of comple
xity of patients operated on, the duration of surgical procedures are much
more prolonged.
To perform an activity of 600 procedures (extra-corporeal circulation
and aorto-coronary grafts without extra-corporeal circulation)/year an ave
rage duration of 4 hours (for these procedures) and an occupation of 70%
for an operating room used 248 days a year, 7 hours a day, two operating
rooms dedicated to this end shall be available.
Upon the termination of the surgical procedures, the clinical register
of the patient should show times used in all phases of the procedure, iden
tify the professionals involved in the same and their responsibilities, and
include(73) the Surgical Report, the Anaesthesia Report, the Perfusion
Report and the Nursing Report.
The necessary personnel to perform a cardiovascular procedure inclu
de:
A minimum of two surgeons, both CCV specialists. In complex pro
cedures three surgeons are necessary, at least two of them specialists
in cardiovascular surgery.
At least one anaesthesiology expert with special interest, dedication
and preparation in cardiovascular surgery.
At least one anaesthesia support nurse.
At least an instrumentalist nurse with a special preparation and
devotion to CVS.
At least one instrumentalist nurse with special preparation and
dedication to CCV.
(73)
See: Bloque Quirrgico. Estndares y recomendaciones. NHS Agency of Quality. 2009.
(74)
See: Intensive care unit. Estndares y recomendaciones. NHS Agency of Quality. 2010.
Hospitlization(75)
The unit of CCV hospitalization has similar characteristic to the rest of
multi-valid hospitalization units, necessarily counting on the specific tools
detailed in Attachment 15.
Support
Including offices and conference room.
(75)
See: Unidad de enfermera de hospitalizacin polivalente de agudos. Estndares y reco
mendaciones. NHS Agency of Quality. 2010.
Quality indexes
The CCV service or unit shall maintain quality indexes in different phases
of the activity which permit the evaluation of the functioning of areas and
structures. The indexes shall remain registered in a computerized program
and analyzed by pre-fixed periods. The most common are stated:
Improvement actions
Confronted with any unsatisfactory quality index it shall be established that
corrective actions will be placed into action, in which manner the effects of
these actions are to be documented and in what time in the future a new
evaluation will be carried out. If the quality indexes are satisfactory, new
quality objectives will be established at a higher level for the following
period.
Professional accreditation
The cardiovascular surgeons shall have and accredit degrees in Medicine
and Surgery and the degree in the Speciality of Cardiovascular Surgery.
Post-graduate teaching in the CCV services or units can only be performed
Institutional accreditation
The EACTS has established criteria for the voluntary accreditation of CCV
services. The accreditation has a validity of 5 years, after which it shall be
renewed. The accreditation of a service is determined following the evalua
tion and recommendation carried out in situ by an evaluating group
designated by the EACTS. The process is paid for by the institution. At pres
ent time there are only two accredited services in Spain and another in the
process of accreditation.
The quality program in CCV shall include and fulfil the following
requirements:
An adequate volume and distribution of groups of patients.
A basis for the collection of reliable data. It is advisable to use one
of the collection systems at present in use in Spain.
Participation in a register of activity and collective results. The regis
ter of the EACTS is advisable.
Results adjusted to calculable risk by EuroScore.
Global satisfactory EuroScore and in all groups of patients.
Well structured mortality sessions.
Quality indexes and improvement mechanisms.
Professional accreditation of all its members.
Teaching accreditation of the service by the MSPSI.
In the access to the unit, a counter and an administrative work zone, which
serves for the reception of ambulatory patients is available.
Alongside the access, the availability of a space for wheelchairs is rec
ommended.
From the vestibule of access to the unit there will bean access to the waiting
room for relatives, in whose proximity will be found the nucleus of public
restrooms, at least one of which shall be adapted for the use of invalid peo
ple in wheelchairs.
It is recommended that the sitting room have natural illumination, sized
according to programmed activity, installation for a water fountain, etc.
Cardiac patients shall have a different sitting room with a specific rest
room containing a zone which permits baby changing and the parking of
strollers..
Information office
At the same time, in the surroundings of the access to the unit there shall be
an information office, which is set up with the objective of holding inter-
Consultation zone
The access and reception zone defined, serves for the consultation zone, as
well as, generally for the zone of functional central explorations, so the con
sultations remain associated to the exploration offices without a delimited
zoning. In this case, which is recommended in general, it is necessary to
locate the heart area so that it permit access to ambulatory patients as well
as in-patients.
In this situation, the consultations locales are found in the closest
external circulation zone and the central examinations offices, associated to
the internal circulation of the hospital.
This solution permits, at the same time, the availability of a series of
locales (clean closet for pharmacy and fungible material, cleaning job, dirty
job, bed-clothes storage room, equipment storage room, rest and dressing
rooms for personnel) shared between the consultation zone and the central
functional examination offices.
Waiting room
Nursing consultation
With a work counter and space for fungible and pharmaceutical material,
linked to the consultation locales.The nursing consultation space is the cen
tre of communications of the zone, necessarily having the communication
infrastructure, as well as the terminal for the pneumatic transport installa
tion.There shall be located in this consultation a space for the resuscitation
cart (defibrillator). This equipment shall be located in a visible place, with
out obstacles for its transfer through the Unit.
The room shall permit the stay and movement of the ambulatory as well as
bedded patient, with the possibility of being accompanied, with space for an
echo-cardiograph (trans-thoracic, trans-oesophagus, 3-D, stress and con
trast) and in the case may be, a cardiologist and an echo-cardiograph tech
nician.
At the same time, space for a portable echo-cardiograph shall
exist.There shall be enough space for the patient to be accessible on all four
sides of the bed or chair. For the performance of a stress and trans-oesoph
agus echo-cardiogram, additional equipment is required (pulsioximetre for
the measurement of the oxygen level, storage of probes.).
In this case, the movement of the chair shall permit the downward
inclination of the upper part to prevent the sedated patient from vomiting
Stress echocardiograph
The stress echocardiography can be carried out with stress (treadmills for
marching or bicycles) or through pharmacological stress. Although the dif-
Recuperation room
Ergometry
This room is destined for the ambulatory patient and should cover the pos
sibility that he be accompanied, and attended to by two physiologists and, if
the case may be, a cardiologist Surrounding the patient there should be
enough space for him to be attended to.
There must be enough space around the patient to be treated. The
room is equipped with an ECG installed on a portable cart, a sphingo-
Electrocardiograms (ECG)
Each room shall be capable of attending to one patient who can be accom
panied and attended to by one physiologist and occasionally by a cardiolo
gist.
As in the rest of the exploration rooms, the dimensions of the room
and the elements of access shall be designed for the use by ambulatory as
well as bedded patients.
Each room shall have at least one cabin to facilitate the preparation of
the patient.
In the case of having a common room for the performance of ECG, the
patients shall have adequate privacy during the performance of the test.
Holter
In this room Ambulatory Holter patients are installed and the equipment
for the recording of ECG and blood pressure for 24 hours.
The room shall have space for the storage of portable equipment.
Records room
With installation and equipment which permit the analysis and program
ming of implantable mechanisms in patients.
The room shall have a chair to accommodate the patient, which shall
be accessible on all sides to professionals and equipment..
The Central Functional Exploration Offices zone shall have a control post
for nursing personnel to work, which will be located in the central zone with
respect to the exploration locales of the patients, to minimize routes and
facilitate the vision and rapid access to the patients with urgent healthcare
needs.
All patients can require to be accessed by RCP equipment with defib
rillator, as well as oxygen and vacuum installation. This equipment shall be
located in a defined space and accessible to the nurse station.At the same
time, the patients can require the supplying of medicinal gases, oxygen and
vacuum, for which it is necessary that all locales (consultations, offices, hos
pitalized patient waiting rooms) in which a patient is attended to must have
centralized medicinal gas, oxygen and vacuum installation.
The control post will have a counter with a surface for personnel work
and communication equipment installation, including the central reception
of calls to the nurse and space for the storage of work material, as well as a
personnel work zone, which will have a clinical station for the access to the
hospital information system and the work with the computerized clinical
record.
Next to the personnel work counter a terminal for the pneumatic
transport system of samples and documents, as well as diverse alarms and an
installation panel are located.
Associated to the counter and work zone of the control post there are
different support locales for the functioning of the personnel of the zone:
clean closet, hospitalized patient waiting room, patient recuperation room,
dirty closet,
Clean closet
In the room linked to that counter zone and personnel work zone, there is
a clean closet with a work zone for the preparation of clean material, sink,
refrigerator for clinical use, cupboards, automatic medicine dispensers and
fungible material.
This room serves for the storage under safety conditions (refrigerator
and freezer) of medicine and clean and sterile therapeutic material.
The shelves and material trays should be separated enough from the
floor to permit the easy cleaning of the same.
For the stay of the bedded hospitalized patient, before the performance of
a functional exploration in this zone.
It can also serve for patient recuperation after an exploration, which in
general is resolved in the Medical Day Hospital zone, which shall be locat
ed in a zone nearby which is connected to through internal hospital circula
tion.
This room shall be located in a a place within the internal circulation
Office Zone, near the nurse station. It shall have an oxygen and vacuum
installation.
Space for the storage supplies for the functioning of the zone.
Linen Warehouse
Like the rest of the material, the size and characteristics of the clean clothes
storage room depends on the policy for storage and management, and the
frequency of distribution. Normally it is carried out on carts which are peri
odically replaced.
It is necessary to have a room with ample access for the storage of equip
ment, pacemakers and portable equipment. The room shall be equipped
with open shelves as well as a free space for large equipment.
The room shall have electrical sockets to permit the recharging of
equipment batteries.
Electrical sockets at a height which prevent professionals having to
bend over are recommended. The room shall have a small workshop table
to enable the service technician to perform repairs which can be done in the
room or calibrations of material, as well as a file for the follow-up of mate
rial incidents.
This room serves for support to the daily activity of the cleaning service.The
room shall have a sink and a counter, space for mobile equipment storage
and cleaning material for rooms and zone equipment.
The dirty job should be located next to the nurse station, and will have
enough space for different containers to be located which make the
advanced classification of clinical, infectious and urban waste possible. It
shall have a clinical sink and tip..
The locales destined to rest and dressing rooms for professionals in the
zone, are located in a place near the access by professionals to the zone
through internal circulation of the hospital.Their size will be in accordance
with the number of rooms and the type of programmed explorations..
The term hybrid operating room indicates that operating room in which
the cardiologic radiology imaging equipment is integrated, so that radiolo
gy and vascular surgical interventions prove to be appropriate. In theory it
permits the development of new therapy techniques, and a greater safety for
the patient in this type of interventions which incorporate multi-disciplinary
teams of cardiologists, cardiac surgeons, vascular surgeons and radiology
interventionists. In particular, it permits attending to an emergency or com
plication during a vascular catheterization treatment through the perform
ance of a surgical intervention. In reality, the hybrid operating room is an
operating room with a cardiac catheterization laboratory integrated. At the
same time, this solution makes possible the post-operation therapeutic
supervision.
The minimum free height of the operating room shall not be inferior
to 3.00 metres (in accordance with the imaging equipment to be installed),
with a minimum height of a false ceiling of 1.2 m.
There isnt enough information available to evaluate the relation
between cost and profit of these structures in comparison to the more tra
ditional solution (hemodynamics room and operating room).
Control room
The intervention rooms will be communicated visually with the control
room through a leaded glass window. Said window located at the smallest
side of the intervention room, in front of the patients table, on the opposite
side of the radiology equipment.
Personnel preparation
The room for the depositing of sterile material, surgical tools, devices and
fungible material.
It shall have positive pressure with a climate control system with
absolute filters.
A space for anaesthesia material is, at the same time, required.
This storage room will be situated in a zone near the intervention
room.
There shall be a room for patients preparation, and, if the case may be,
recuperation, although this is normally carried out in the Medical Day Hos
pital of the Heart Unit.
This room should be located in the proximity of the access to inter
vention rooms and alongside the nurse station It should have a centralized
oxygen and vacuum installation. It should have an oxygen and vacuum
installation.
A room is required for the holding of hospitalized patients and, if the case
may be, recuperation after an intervention. It shall located in a space con
tiguous to the nurse station of te zone, and have a centralized oxygen and
vacuum installation. Each post shall have a space for the placement of a
monitor.
Nursing control
From the nurse station post the reception and continuous observation of the
intervention zone is carried out. It shall be located in the proximity of the
preparation and recuperation rooms of the patients after an intervention,
preferably with a certain amount of privacy between posts, as well as having
a specific space for paediatric patients.
Open room for the situation of various personnel work posts and an area,
for the analysis, interpretation and valuing of images, equipped with voice
and data terminals. It shall have, at the same time, a small meeting area.This
room shall have a digital work station which permits the visualization of
images obtained in the interventions rooms.
Doctors office
Office for the writing up of reports after interventions, with computer and
telematic connections.
This premise will incorporate the necessary space for the healthcare to the
patient and the people accompanying him (a certain grade of privacy shall
be kept in mind) during the admissions process in which personal data,
determination of appointments, organization of lists and foreseeing of
errors, communications with patients, etc. area carried out.Administrative
admission procedures for the patient, if necessary, are also carried out. The
administrative area will have the necessary equipment to efficiently devel
op its activity (computing, e-mail, telephones, fax, answering machine for
after working hours) and prepare a space to keep specific documentation:
protocols, information brochures, etc.
The reception counter will be designed in a manner which makes it
accessible from the main entrance and easily located by patients and people
accompanying them, and, that reception personnel can observe the entrance
door and public circulation.
It is recommended that all administrative procedures are done, as long
as possible, in the very reception counter, avoiding the need for adjacent
offices.
It is considered that, in new designs, the information system shall inte
grally support the development of all activities, including, besides those
merely considered to be administrative, the management of clinical docu
mentation.
Adjacent to admissions, there shall be a space for the patients and relatives
to wait, which can be the same used for waiting during treatment and recu
peration.
It will be a comfortable area and will have restrooms, telephone, tele
vision and an automatic cold water fountain.
The size of the waiting area will depend on the foreseen activity and
the social-cultural characteristics of the population, counting on 1.5 com
fortable seats (waiting time can be long) per patient which is to be found in
any area of the unit.
This main waiting room will have preferential direct access from the
entrance vestibule, will permit visual contact with the reception counter and
will provide access to the day hospital area, especially consultations and
patient posts.
The patient dressing rooms are situated in a space next to the day hospital
posts. There will be differentiated between men and women and shall have
enough space for lockers, which permit the custody of clothes and personal
objects.They shall have restrooms for patients (including a shower), situat
ed next to the dressing room, provisioned similarly to public restrooms,
adapted for patients with reduced mobility and with a size adequate to the
unit.
Nurse station
The day Hospital area shall have a clean closet (for pharmacy preparation),
ready for the management of medication used and which shall be located
next to the nurse station. In this room the sterile material for the area will
be stored.
Meal closet
Cleaning closet
Locale for the depositing of dirty clothes and with space for the advance
classification of waste. With a water source and tip.
Rest and dressing rooms for nursing personnel of the Day Hospital area.
Should include sink, toilet and shower.Personnel zoneIn this area different
physical resources are situated destined to the organization of medical work
of the different healthcare areas of the Heart Unit.
Clinical office
Open room with work posts with voice and data communications and
with a small space for meetings.
Administrative work post of the Heart Unit, with space for filing and a
reprography room.
Multi-service room with enough space for the holding of clinical sessions,
teaching, formation, residents, with equipment which permits the applica
tion of tele-medicine (video-conference, imaging connection to interven
tion, teaching rooms, etc.).
Locale for the resting of the personnel, equipped with a small space for the
conservation and preparation of light food and drinks. It includes having a
sink and a small storage space.
Locales destined to rest and dressing rooms for professional in the cardiol
ogy area.
ECI-SNS Indicators
The ECI-SNS has elaborated a group of indicators to monitor the achieve
ment of strategy objectives. Those which are specifically applicable to the
UAACare the Use of arterial grafts in re-vascularized patients, he rate of
re-interventions in re-vascularized patients, the intra-hospital Mortality
after coronary angio-plasty (global, in patients with acute myocardial infarc
tion, patients without acute myocardial infarction), the hospital Mortality
after coronary surgery.
The formula for the Use of arterial grafts in re-vascularized patients is
(a / b)*100, a being, the number of re-vascularized patients with arterial
graft, in one year, and b, the total of patients re-vascularized through proce
dures which require the use of grafts, in this year. Including all those releas
es in which the procedural codes of international classification of illnesses
(CIE9, version 9-MC appear: Numerator: 36.15, 36.16, 36.17, 36.2; Denomi
nator: 36.03, 36.10 to 36.17, 36.2. Source: Register of hospitalization releases
(CMBD), MSPSI.
The formula of Rate of re-interventions in re-vascularized patients is
(a / b)*100, a being, the number of releases with coronary re-vascularization,
whether through angio-plasty or through coronary surgery, in patients who
have already been submitted to a re-vascularization, iin a period of time
prior to the year and b, the Total of releases with re-vascularization proce
dures. This global indicator can be sub-divided, mainly, in two, keeping in
mind the type of initial procedures to which the patient was submitted. In
this manner, the following complementary indicators will be found: A)
(76)
Source: http://www.msc.es/estadEstudios/estadisticas/cmbdhome.htm. Datos 2007. Own cre
ation.
(77)
Peterson ED, Ohman EM, Brindis RG, Cohen DJ, Magid DJ. Development of Systems of
Care for ST-Elevation Myocardial Infarction Patients. Evaluation and Outcomes. Circulation.
2007;116:e64-e67. Consultado en
http://circ.ahajournals.org/cgi/content/full/116/2/e73, el 14.11.09.
(78)
Adapted from: Unidad de pacientes pluripatolgicos. Estndares y recomendaciones. AC
SNS, MSPS 2009.
(79)
The epidemiology introduction is based on Quintana and cols. 2008.
(80)
Source: GRD databases Own creation. It was considered the GRD, 127 Heart failure and
shock. It does not contain the secondary CHF diagnosis but other main diagnoses.
(81)
Adapted from: Improving Chronic Disease Management. Department of Health. 3 March
2004.
Services portfolio
The CCUs-heart failure unit can have various levels of deployment of the
service roster:
The pathologies which it attends to, listed by the GRD, for example. It
is recommended that the reference unit for all stable cardiac pathology in a
determined population be the heart failure unit.The healthcare modalities
which are offered in the unit. Every heart failure unit shall offer health
healthcare to the patient with congestive heart failure in the conventional
hospitalization unit and, in ambulatory form, in external consultations and
in the day hospital (Hd) or in the multi-service DCH.
The procedures which are carried out.The amplitude and conditions of
the services roster will be according to the organization of each hospital, the
size of the heart failure unit and the resources available, the organization
and management of the same and the reference population.
Circuits
In collaboration with primary healthcare, circuits shall be elaborated for the
programmed of direct emergency and programmed admissions, as well as
for the programmed of procedures after hospital discharge. Special consid
eration shall be taken to:
Define circuits to guarantee emergency preferential specialized
healthcare, without having to go through the emergency service.
Facilitate primary healthcare doctor and nurse hospital visits to the
patient with a prolonged stay.
Avoid merely bureaucratic referrals, appointments and revisions, as
well as revisions in the stable phase and appointments to set up explo
rations, deliver reports or make out prescriptions. Shared clinical
information can resolve the immense majority of those procedures.
(82)
This annex has been elaborated with the contributions of Virginia Argibay.
(83)
Sociedad Espaola de Cardiologa (SEC) y Sociedad de Radiologa Mdica (SERAM).
Comisin de Trabajo Paritaria. Acta y Propuestas de colaboracin (Valencia, 22 de octubre de
2010).
(84)
Adapted from the contributions, given for this document on standards and recommenda
tions, by Javier Goicolea, updating the SEC's guide. Mors de la Tassa C (Coord.), Cequier AR,
Moreu J, Prez H, Aguirre JM. Guas de prctica clnica de la Sociedad Espaola de Cardiolo
ga sobre requerimientos y equipamiento en hemodinmica y cardiologa intervencionista. Rev
Esp Cardiol 2001; 54: 741-750.
(85)
See at: Bloque Quirrgico. Estndares y recomendaciones. AC-SNS. 2010. 7.2.3.. Sistemas de
climatizacin en quirfanos. La climatizacin del gabinete de hemodinmica debe cumplir los
requisitos de un quirfano tipo B.
The area where work is carried out shall be built with a complete lead
shield and have medium conditions of sterility. There shall be air-condition-
Hemodynamics equipment
In new creation laboratories, the radiological chain shall necessarily
include the following elements:
Generator
X-Ray tube
Flat image detector
MonitorsImage digital register systems
Arch deviceExploration table
Automatic injector
Protection system against ionized radiation
This equipment demands a mandatory annual control and mainte
nance. The provision of a technical team, near in time and space, is very
important, to avoid problems derived from failures in the equipment which
can be important for the patient.
The following basic components of these elements and minimums
demanded for each one of them, as well as some non-essential components
of the equipment like surgical ceiling light and technical equipment for
intra-coronary diagnosis are described.
Flat detector
Imagery system based on flat panel.
Flat detector of at least 17x17 cm.
At least three vision fields.
Anti-collision system integrated in the detector casing.
It will allow acquisition matrix of 1024x1024.
Capacity to acquire up to 25 images per second. Ease in grille with
drawal.
Upon the flat panel choice, it shall be considered: higher quantum
detention rate; higher space resolution; smaller photodiode size.
Exploration table
Carbon fibre board.
Electromagnetic blocking system which permits manual transversal
and longitudinal movement.
Motorized vertical movement
Facilities for the connection of the module of data acquisition from
the polygraph and optionally with a handling console for the
intravascular echo-graph equipment
Ample margin in any movement.
Optional elements
More and more often, it is more necessary to have support circulatory sys
tems in the hemodynamics unit, as a consequence of the generalization of
certain procedures like the percutaneous re-vascularization of the common
trunk; primary angio-plasty in infarction and in cases of cardio-genic shock;
or the intervention on structural cardio-pathologies (valves, closing of con-
genital defects in the adult)
It is indispensable that there be a intra-aorta contra-pulsation balloon.
The catheters shall be ready in the hemodynamics unit, but the console can
come from the coronary or cardiovascular post-operatory, it shall be adapt
able to any type of balloon, transportable and with a minimum autonomy of
3 h. The use of the percutaneous implantation system of cardiopulmonary
referral has become extended, conceived as a measure of hemodynamics
support in patients in cardio-genic shock (post-infarction, non ischemic
myocardial pathologies, post surgery) as a bridge to a cardiac transplant
or waiting for a certain functional solution (for example, myocarditis, post
infarction with re-perfusion).
The prolonging of the waiting period for a cardiac transplant in 0 alert
which is observed in these last years, makes these systems more neces
sary.Nevertheless their placing is much more frequent in the field of the
coronary unit and cardiac post-operation patients or in the cardiovascular
operating room than in the hemodynamics unit..
Clinical information
The unit shall have a database. There are various specifically designed for
the hemodynamics unit, which permit storage and management of all
patient data:
The simultaneous access with the base and the image files will permit
the revision of each case in an integral manner to elaborate reports, studies
or statistics. This system, besides fulfilling the legal requirements for data
protection shallimgenes archivadas en menos de 30 (revisin diagnstica)
y permitir visualizar desde soportes externos (CD, DVD) shall:
Support DICOM 3 (Norm ACCINEMA).
HLT protocols or later performances of the same, as well as IHE
recommendations.
It shall be configurable for its adaptation to the necessities of the
user.
It shall be integrated in an automatic and immediate manner with
the acquisition of fluoroscopic images.
The application of image visualization and making up of hemody
namics reports shall be able to be installed in the same stations,
capable of launching the image visor from the visualization system.
It shall permit a bi-lateral communication with the rest of the exist
ing medical devices in the unit and with the hospital information sys
tem for works lists (Work list).
86
Numerical references are avoided as the number of equipments will depend on the size and
other structural and functional variables of the CCUs.
Knowledge
Anatomy and cardiovascular physilogy
Biology and vascular pathology
Physiopathology (with clinical uses: intracoronary image,).
Pharmacology (including anti-thrombotic agents and thrombotic
therapy, contrast agents)
Radiological image and safe use of radiation Patient selection, indi
cations and limitations
Design and performance of the interventionalt devices
Clinical management and strategy, before and alter the procedure
Skills
Procedure schedule. All professionals under training shall hold a
continuous record of the procedures they perform in the hemody
namic lab. The procedure schedule must give details of the injury
complexity, the types of devices used and the complications. It must
also indicate when the case was planned and emergency.
The skills assessment of the Interventional Cardiology Accredita
tion shall include three directly observed procedures (DOPs) for
each of the following aspects of the curriculum for nuclear medicine:
diagnostic cardiac catheterization, percutaneous coronary interven
tion (PCI) for Benestent-like lesions, PCI for acute coronary syn
(87)
Javier Goicolea.
Attitudes
To learn PCI techniques and prove the capacity to get to know, both
through learning and in independent way.
To treat each patient as an individual and design each intervention
for each particular case.
To foster a good relationship among the multitasked team.
To have a calm behaviour when the PCI passes off in a complicated
manner and with adverse effects.
To be able to write a condolence letter to the families after a patient dyes.
These modules are assessed in an independent way. The Section of
Hemodynamics and Intervention Cardiology is taking part in the develop
ment of a system that includes the creation of a standardized list of topics
common to all Europe. El goal consists of a common certification, depend
ing on each countrys obligatory nature of criteria.
Training level
In hemodynamics and interventional cardiology, there are three levels of
training236,237:
Level 1 Training in cardiac hemodynamics, but without capacity to
subsequently do cardiac catheterization in an independent way.
Level 2 Training to do diagnostic cardiac catheterization in an inde
pendent way.
Level 3 Training to do diagnostic cardiac catheterization and inter
ventional or percutaneous therapeutic procedures (PCI, aterectomy,
stent implantation, valvuloplasty, etc.).
Training elements
The Level 1 of Training in cardiac hemodynamics, but without competence
to subsequently do cardiac catheterization in an independent way. He/she
Training centre
Multiple data indicate that they is a almost logarithmic relation between the
number of procedures done in an specific centre and the results obtaines
(Jollis, 94; Hannan, 97). In general, the hospital in which the few procedures
are done have a higher incidence of complications, mainly death and the
need of urgent surgery due to failed intervention, than a hospital doing a
higher number of procedures. It is necessary that each centre have a good
and effective monitoring of the cardiac catheterization and interventional
therapy programme, both generally and individually of the surgeons. The
centres must try to maintain a level of activity of more than 400 procedures
per year. The centre with less than 200 yearly procedures shall carefully
assess the interventional indications242. he laboratory that offers the level 2
training in hemodynamics shall have more than one expert hemodynamist
among the staff. For the training in interventional procedures, there must be
at least an hemodynamist expert in the training subjects.
(88)
Josep Brugada; Brugada y cols., 2001.
(89)
For an activity of 600 surgical interventions with extracorporeal circulation or aortocoro
nary graft without extracorporeal circulation. See also: Intensive care unit. Estndares y reco
mendaciones. NHS Agency of Quality. Ministry for Health and Social Policy. 2010. This attach
ment refers to those specific resources.
Hospital bed
Complete technical bar with accessories.
Compressed air, O2 and vacuum sockets
Electrical articulated bed with easy exit from the room
Electrical connections for high power apparatuses
Quality audit:
Process by which the books, accounts and registers of a company are
analysed in order to tell whether its financial statement is correct or not and
if receipts are properly submitted. Independent and methodological study to
determine whether the activities and the results related to quality comply
with the pre-established provisions or not, and to verify if these provisions are
effectively executed and if they are appropriate to achieve the intended goals.
Authorization
Healthcare authorization: administrative resolution that, according to
the established requirements, authorizes a healthcare establishment, centre
or service to set up, function, modify its medical activities or, where appro
priate, close.
Source: R.D. 1277/2003, of 10th October, laying the general basis for the
authorization of healthcare centres, services and establishments.
Services portfolio
Set of techniques, technologies or procedures, understood as each of
the methods, activities and resources based on scientific experimentation
and knowledge, through which healthcare services are provided in a health
care centre, service or facility.
Healthcare centre
Organized group of technical resources and facilities in which quali
fied professionals (for their official certification or professional authoriza
tion) carry out healthcare activities with the aim of improving peoples
health.
Source: R.D. 1277/2003, of 10th October, laying the general basis for the
authorization of healthcare centres, services and establishments.
Code of ethics
Set of standards or ethical rules that the healthcare centre applies to
the professional conduct related to its patients care.
Informed consent
Free, voluntary and conscious consent by a patient, granted in his/her
sound and sober senses, after having received the proper information, so
that action effects his/her health can take place.
Critical care
It is an integral system that responds to the needs of those patients at
risk of critical disease during the disease itself and those who are already
recovered from it. Its provision depends on the availability of continuous
experience and facilities, within hospitals and between them, regardless of
the place and the speciality.
Comprehensive Critical Care. A Review of Adult Critical Care Ser
vices. Department of Health. May 2000.
Clinical documentation
Any data, regardless of it form, class or type, allowing to get or broad
en knowledge on the physical state and health of a person or on the way to
preserve it, take care of it, cure it or recover it (Art. 3 of Law 41/2002, regu
latory basis for the patients autonomy, rights and obligations concerning
information and clinical documents).
Emergency
That urgent situation that put the patients life or an organ function at risk.
Source: WHO
Healthcare emergency that put a persons life or important biological
functions at -real or potential- risk and that requires qualified immediate
care on the spot. Special kinds of emergency are: the multi-victim accidents
or collective emergencies (those in which the system healthcare capacity is
exceeded when there are several patients) and the catastrophe, which is that
situation where available resources are not enough to face healthcare needs.
Source: Grupo de Trabajo SEMES. Calidad en los servicios de urgen
cias y emergencias. SEMES, 1998.
Medical history
Group of records containing data, evaluations and information of any
nature on the medical situation and evaluation of a patient along with the
assisting process. It includes the identifications of the doctors and other pro
fessionals that have been contributed to the assisting processes (Art. 3 and
14 of the Law 41/2002, regulatory base of the patients autonomy, rights and
obligations concerning information and legal records).
Local hospital
In this document, a local hospital is understood as the hospital having
a reference area with a surrounding population up to 100,000 inhabitants,
Conventional hospitalization
Admission of a patient with an acute or cronic re-acute disease to an
organised nursing unit that is capable of providing healthcare and interme
diate and non-critical care 24 hours a day, and where patients stay more than
24 hours. The advisable features of this hospitalization nursing units that are
appropriate for treating a patient suffering a heart disease are explained in
this document.
Source: Unidad de enfermera de hospitalizacin polivalente de agu
dos. Estndares y recomendaciones. QA-NHS. MSPSI 2010.
Day hospitalization
Healthcare modality that is aimed at providing treatment or care to ill
patients who undergo treatment or diagnostic methods requiring continu
ous medical or nursing attention for some hours, but not the hospitalization
in the hospital.
Source: Unidad de urgencias hospitalarias: estndares y recomenda
ciones. AC-SNS. MSPSI 2009.
Discharge report
Document issued by the doctor responsible for a healthcare centre at
the end of every healthcare process on a patient or on a patients transfer to
another healthcare centre, in which figure the patients details and medical
record summary, the healthcare provided, the diagnosis and the therapeutic
recommendations.
Other similar terms used: medical/clinical discharge form (Art. 3 of the
basic regulatory Law 41/2002 on patients autonomy and on the rights and
duties in relation to medical information and documentation; Order by the
Ministry for Health, of 6th September 1984.
Healthcare intervals
Examination interval healthcare requestTime in minutes from the
examination start time until the healthcare request time. TS-TC.
Admitted patient
Patient admitted (stays overnight) in a hospital bed
Healthcare network
The ECI-NHS defines the healthcare network as coordinated work,
according to the grade of complexity, of the different levels of healthcare
(healthcare at home, extra-hospital emergency, healthcare in health centres,
hospital emergency, programmed hospital healthcare, reference services
and others) in a determined territory (for example, health area, region, etc.)
to attend to in a continuous manner and in the most efficient way possible
different clinical situations.
Source: Estrategia en Cardiopata Isqumica del NHS (Strategy for
Ischemic Cardiomyopathy of the NHS). MSC. 2006.
Regionalization
Concentration of human resources, facilities and equipment in certain
centres to improve quality, safety and efficiency when being used.
Patient registry
Group of selected records about the patients and their relation with
the healthcare centre, with the aim of a healthcare healthcare process.
Authorization requirements
Requirements, expressed in qualitative or quantitative terms, that have
to be met by healthcare establishments, services and centres to be author
ized by the healthcare administration and that are aimed at ensuring that
they have the appropriate technical means, facilities and professionals for
conducting their healthcare activities.
Source: R.D. 1277/2003, of 10th October, laying the general basis for the
authorization of healthcare centres, services and establishments.
Intraining system
Group of processes, automatic or not, that, orderly interconnected,
designed for the administration and support of the different activities that
develop in the healthcare establishments, services and centres, as well as
treatment and exploitation of the records that the formerly mentioned
processes produce.
Emergency department
An organization of healthcare professionals offering multidisciplinary
attention in a specific area of the hospital, which fulfils functional, structur
al and organizational requirements. This way, it assures appropriate safety,
quality and efficiency conditions to treat patients with diverse aetiology and
diverse seriousness problems. These patients are not hospitalized but suffer
from acute diseases requiring immediate care.
Source: Unidad de urgencias hospitalarias: estndares y recomenda
ciones (Eemergency department: standards and recommendations. AC
SNS. MSPSI 2010.
Emergency
The accidental (sudden or unexpected) emergence, at any place or
during any activity, of a health problem having diverse causes and serious
ness, which makes the person suffering from it and his/her family aware of
the imminent need to be assisted.
Source: WHO
Emergency is every condition that, according to the patient, his/her
family or whoever is responsible for the request, requires immediate health
care.
Source: American Medical Association (A.M.A.).