1、March 2015 Translation by DIN-Sprachendienst.English price group 16No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、11.020!%A*J“2300739www.din.deDDIN EN 16224Healthcare provision by chiropractors;English version EN 16224:2012+A1:2014,English translation of DIN EN 16224:2015-03Bereitstellung von Gesundheitsleistungen durch Chiropraktoren;Englische Fassung EN 16224:2012+A1:2014,Englische bersetzung von DIN EN 16224
3、:2015-03Prestation de soins de sant par les chiropracteurs;Version anglaise EN 16224:2012+A1:2014,Traduction anglaise de DIN EN 16224:2015-03SupersedesDIN EN 16224:2012-09www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 37 pages 02.15 DI
4、N EN 16224:2015-03 2 A comma is used as the decimal marker. National foreword This document (EN 16224:2012+A1:2014) has been prepared by Technical Committee CEN/TC 394 “Project Committee Services of chiropractors” (Secretariat: ASI, Austria), The responsible German body involved in its preparation w
5、as the Normenausschuss Dienstleistungen (DIN Standards Committee Services), Working Committee NA 159 BR Beirat des DIN-Normenausschusses Dienstleistungen (NADL). The EN Standard was developed without the participation of German experts. Amendments This standard differs from DIN EN 16224:2012-09 as f
6、ollows: a) the wording of the German version has been modified to be in compliance with the English reference version; b) Annex D “A-deviations” has been added. Previous editions DIN EN 16224: 2012-09 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 16224:2012+A1 January 2014 ICS 03.120.10; 11.0
7、20 Supersedes EN 16224:2012English Version Healthcare provision by chiropractors Prestation de soins de sant par les chiropracteurs Bereitstellung von Gesundheitsleistungen durch Chiropraktoren This European Standard was approved by CEN on 10 May 2012 and includes Amendment 1 approved by CEN on 12 D
8、ecember 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be
9、 obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to t
10、he CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ir
11、eland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management C
12、entre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16224:2012+A1:2014 EEN 16224:2012+A1:2014 (E) 2 Contents Page Foreword 5 Introduction .6 1 Scope 7 2 Terms and definitions .7 3 Service r
13、equirements . 10 3.1 Clinical practice 10 3.1.1 Clinical records . 10 3.1.2 Case history 10 3.1.3 Patient examination 10 3.1.4 Further investigation / diagnostic imaging 10 3.1.5 Clinical decision making and diagnosis 10 3.1.6 Plan of care 11 3.1.7 Referrals 11 3.1.8 Use of equipment 11 3.2 Core com
14、petencies . 11 4 Education . 13 4.1 Undergraduate chiropractic education. 13 4.2 Graduate education programme . 13 4.3 Continuing professional development . 13 5 Code of ethics . 14 6 Organisation 14 6.1 Practical organisation of clinic facilities 14 6.2 Facility requirements 14 6.2.1 General . 14 6
15、.2.2 Clinic and hygiene 14 6.2.3 Access to the clinic 15 6.2.4 Reception and waiting areas . 15 6.2.5 Toilet 15 6.2.6 Consultation and treatment room . 15 6.3 Equipment requirements . 15 6.3.1 Equipment . 15 6.3.2 Maintenance 16 6.4 Incident reporting and learning . 16 6.5 Quality assurance . 16 6.6
16、 Insurance . 16 6.7 Professional association membership . 16 Annex A (informative) Patient records . 17 A.1 Duty to keep patient records . 17 A.2 Content of patient records . 17 A.3 Correction of patient records 17 Annex B (informative) Recommended programme curriculum 18 B.1 General . 18 B.2 Curric
17、ulum model and educational methods 18 B.3 Basic biomedical sciences 19 DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E) 3 B.4 Behavioural and social sciences, ethics and jurisprudence 19 B.5 Clinical sciences and skills 20 B.6 Clinical training 20 B.7 Assessment methods and regulations . 21 B.8 Curric
18、ulum level, structure and composition . 21 Annex C (informative) Code of ethics . 23 C.1 Working with patients . 23 C.1.1 Good clinical care 23 C.1.2 Health promotion and self care 23 C.1.3 Raising concerns about patient safety . 23 C.1.4 Equality and diversity . 24 C.1.5 Keeping up to date 24 C.1.6
19、 Teaching, training, appraising and assessing . 24 C.1.7 The chiropractor-patient partnership 24 C.1.8 Communicating with patients 24 C.1.9 Communicating with other health professionals . 25 C.1.10 Preparing reports for third parties . 25 C.1.11 Children and young people 26 C.1.12 Vulnerable adults
20、. 26 C.1.13 Dealing with relatives, carers and partners 26 C.2 Openness and honesty . 26 C.2.1 General . 26 C.2.2 Maintaining trust in the profession . 27 C.2.3 Consent 27 C.2.4 Providing access to patient health records 28 C.2.5 Confidentiality 28 C.2.6 Discharging patients . 28 C.3 Working with co
21、lleagues 29 C.3.1 General . 29 C.3.2 Colleagues conduct and performance . 29 C.3.3 Respect for colleagues . 29 C.3.4 Sharing information with colleagues 29 C.3.5 Delegation and referral . 29 C.3.6 Honesty and trustworthiness . 30 C.3.7 Providing and publishing information about chiropractic services
22、 30 C.3.8 Writing reports and giving evidence . 30 C.3.9 Research. 30 C.3.10 Financial dealings . 31 C.3.11 Conflicts of interest . 31 DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E)4 C.4 Health and safety 31 C.4.1 General . 31 C.4.2 Evidence-based care 31 !Annex D (informative) A-deviations“ . 32 Bi
23、bliography . 35 DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E)5 Foreword This document (EN 16224:2012+A1:2014) has been prepared by Technical Committee CEN/TC 394 “Project Committee - Services of chiropractors”, the secretariat of which is held by ASI. This European Standard shall be given the statu
24、s of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2014, and conflicting national standards shall be withdrawn at the latest by July 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of
25、 patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 16224:2012. This document includes Amendment 1 approved by CEN on 12 December 2013. The start and finish of text introduced or altered by amendment is indicated
26、 in the text by tags !“. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic
27、of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E) 6 Introduction
28、The World Health Organization (WHO) defines chiropractic as a primary contact healthcare profession concerned with disorders of the neuromusculoskeletal system, particularly the spine, and the effect of these disorders on the function of the nervous system and on general health. Treatment encompasse
29、s a wide range of interventions, but emphasis is placed on manual methods of care. The chiropractic profession has evolved in Europe and occupies an important position in both primary and secondary healthcare provision. It is therefore imperative that chiropractic services are delivered at the highe
30、st attainable level. The principal objective of any standard for healthcare services ought to be that users of any given service can be confident of a level of care that assures reproducible quality throughout the profession. Clinical governance, the determination of monitoring healthcare provision
31、and ensuring maintenance of standards therefore form one of the cornerstones of care. This standard is concerned with the provision of chiropractic services. It aspires to set a standard that provides optimum levels of patient management, patient safety, clinical and cost effectiveness and ethical p
32、ractice. It also defines a level of education consistent with producing chiropractors who are competent to comply with the standard. It is not intended to be a guideline, although information contained might inform the development of guidelines for individual nations and national organisations. Fina
33、lly, this standard encourages that services provided by chiropractors be subjected to regular review through an evidence-based approach and a commitment to supporting and acting upon clinical research. This European Standard does not supersede national legislation. DIN EN 16224:2015-03 EN 16224:2012
34、+A1:2014 (E) 7 1 Scope This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 assessment health professionals evaluation of a diseas
35、e or condition based on the patients subjective report of the symptoms and course of the illness or condition, along with the objective findings including examination, laboratory tests, diagnostic imaging, medical history and information reported by family members and other health professionals 2.2
36、audit review and assessment of healthcare procedures and documentation for the purposes of comparing the quality of care provided with accepted standards 2.3 biopsychosocial model model that refers to the interactions between biological, psychological and sociological factors 2.4 capacity ability of
37、 a patient to understand, remember and consider information provided to them 2.5 care interventions that are designed to improve health 2.6 case history detailed account of a persons history which results from the acquisition of information through interview, questionnaires and assessment of appropr
38、iate medical records 2.7 chaperone person who is present during a professional encounter between an health professional and a patient EXAMPLE Family members or another member of the healthcare team. 2.8 chiropractic health profession concerned with the diagnosis, treatment and prevention of mechanic
39、al disorders of the musculoskeletal system, and the effects of these disorders on the function of the nervous system and general health Note 1 to entry: There is an emphasis on manual treatments including spinal adjustment and other joint and soft-tissue manipulation. Note 2 to entry: Taken from WFC
40、 Dictionary definition 11. DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E)8 2.9 chiropractic institution educational establishment dedicated to the provision of chiropractic education and training 2.10 clinical guidelines systematically developed statements designed to assist both practitioner and pa
41、tient decisions about the appropriate healthcare for specific clinical circumstances 2.11 clinical record document which relates to the diagnosis, assessment and care of a patient 2.12 consent acceptance by a patient of a proposed clinical intervention after having been informed of all relevant fact
42、ors relating to that intervention 2.13 continuing professional development CPD means by which members of a profession maintain, improve and broaden their knowledge and skills and develop the personal qualities required in their professional lives 2.14 delegation asking someone who is not a regulated
43、 health professional to provide care on a chiropractors behalf 2.15 diagnosis identification of a disease or illness resulting from clinical assessment 2.16 diagnostic procedure structured procedure that exists to enable a chiropractor to arrive at a diagnosis which may include physical examination,
44、 diagnostic imaging and laboratory tests 2.17 discharge release of a patient from a course or programme of care 2.18 evidence-based care clinical practice that incorporates the best available evidence from research, the expertise of the practitioner, and the preference of the patient 2.19 formal edu
45、cation educational activity at established recognised formal systems of elementary, secondary or higher education Note 1 to entry: Compare with the ISO 29990:2010, definition 2.15 “non-formal education“ 4. 2.20 further investigation additional clinical study which contributes to the assessment of a
46、patient and which may include diagnostic imaging and laboratory tests DIN EN 16224:2015-03 EN 16224:2012+A1:2014 (E) 9 2.21 graduate education programme GEP dedicated framework for the continuing education of new graduates of chiropractic institutions during their initial period in practice 2.22 hea
47、lth state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity Note 1 to entry: Specified in the preamble to the “Constitution of the World Health Organization“ 6. 2.23 health promotion provision of information on healthier lifestyles for patients, a
48、nd how to make the best use of health services, with the intention of enabling people to make rational health choices and of ensuring awareness of the factors determining the health of the community 2.24 medical device instrument, apparatus, appliance, material or other article, either used alone or in combination, including the software necessary for its proper application and intended by the manufacturer to be used for human beings Note 1 to entry: This definition is in accordance with Council Directive 93/42/EEC 7 and with EN ISO 13485:2003
