1. Description of at the Head of the Document 4

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Country of the Loire

STRUCTURING IN HALF-VALUE LAYER OF THE DOCUMENT “GENERAL AND PREVIOUS INFORMATION " OF THE PERINATALITY FIELD

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Version Writer Date Comment Chapter Origin 1.0 I Gibaud 09/10/07 Creation of the document *

1.1 I Gibaud 28/01/08 Code Loinc SPOKE Use of a local nomenclature to code the antecedents gyneco-obstetrics Family antecedents relating to the family of the father and the family of the mother: use of code FAMMEMB Correction of the ex of the section “current alcohol/substance misuses”

1.2 I Gibaud 11/03/08  Correction of the example “family history section”: modif of the templateId according to spec  Section “history off tobacco uses” (table) : in the connection with the episode, to replace statusCode by code subject participation: to replace “section by observation  Section “current alcohol” Subject participation: to replace relationShip by entryRelationShip SYNOPSIS

1. DESCRIPTION OF AT THE HEAD OF THE DOCUMENT ...... 4

1.1 CLINICALDOCUMENT ...... 4 1.2 TYPEID ...... 5 1.3 TEMPLATEID...... 5 1.4 ID...... 5 1.5 CODE...... 6 1.6 EFFECTIVETIME...... 6 1.7 CONFIDENTIALITYCODE...... 7 1.8 RECORDTARGET...... 7 1.9 AUTHOR...... 8 1.10 CUSTODIAN...... 8 1.11 AUTHORIZATION/AUTHORIZES ...... 9 2. DESCRIPTION OF THE BODY OF THE DOCUMENTS OF THE PERINATALITY FIELD ...... 11

2.1 STRUCTURING OF LEVEL 2: SECTIONS ...... 11 2.1.1 namespaces and vocabularies ...... 11 2.1.2 Owners of identifiers of documents ...... 11 2.1.3 style sheets ...... 12 2.1.4 The model general of a section ...... 12 2.2 STRUCTURING OF LEVEL 3: ENTRIES ...... 14 2.2.1 Entries of level 3 dedicated to the multi-media posting of information ...... 14 2.2.2 Entries of level 3 dedicated to the exploittation of the structured data: ...... 14 2.3 SPECIFICATION OF THE DOCUMENT “GENERAL INFORMATION AND ANTECEDENTS” ...... 1 2.3.1 structuring of level 2: list sections of the document ...... 1 2.3.2 structuring of level 3: the structured part ...... 3 2.3.3 personal antecedents 11322-5 ...... 21 2.3.4 Medical antecedents (11348-0) ...... 21 2.3.5 surgical antecedents 47519-4 ...... 32 2.3.6 gynéco-obstétricaux antecedents 11449-6 ...... 35 2.3.7 Family antecedents 10157-6 ...... 39 2.3.8 other antecedents 10157-6 ...... 46 2.3.9 Addiction with the tobacco (History off Tobacco uses) 11366-2 ...... 49 2.3.10 Addiction with alcohol and other substances (Current Alcohol/substance misuses) 18663-5 ...... 55 2.3.11 Immunizations 11369-6 ...... 61 This note aims to describe the structuring of the principal documents used within the network of health birth (RSN) of the countries of the Loire. This study relates initially to a restricted number of documents. It will be then generalized with the whole of the documents used by the RSN. The SIB proposes to retain the standard HALF-VALUE LAYER r2[1] of HL7v3 to describe the structuring of these documents. The first paragraph of this note briefly points out the general structure of a document HALF-VALUE LAYER. The following paragraphs describe at the head document HALF-VALUE LAYER which is identical some is the document. The body of the document is then described, it varies according to the nature of the document.

1. DESCRIPTION OF AT THE HEAD OF THE DOCUMENT This section of this document describes in head HALF-VALUE LAYER of a document of perinatality. It refers to the French specification of the metadata of documents CDAr2 (Header) written by HL7-France. All the implementations HALF-VALUE LAYER apply various restrictions and/or constraints compared to the specifications required by the standard. For example, certain implementations retain only the strictly necessary metadata by the standard, others will make compulsory the seizure of one or two metadata not strictly required by the standard. Thus, the majority of the pressures applied to this level correspond to those which are defined in the document of French specifications of the metadata associated with the header[2]. At the head of the document HALF-VALUE LAYER describes the context in which the document is produced. It consists of a whole of metadata which identifies the patient, the meeting between the doctor and the patient who gave place to this document, the list of the participants related to the activity practised during this meeting (author, writer, assentor, etc). The specification HALF-VALUE LAYER in itself ensures that the whole of this information must be able to be posted and to be readable for any user entitled to open the document, in a joint way with the body of the document, using a simple navigator. The posting of the body of the private document of the posting of at the head does not have a direction. In other words, at the head of the document body of the document is indissociable. General constraints on the people and the organizations For each person mentioned in the document, will be specified the name, the address and the telephone co-ordinates of the person.

1.1 CLINICALDOCUMENT The root of a document HALF-VALUE LAYER is obligatorily a ClinicalDocument element of the space of naming urn: hl7-org: v3. Example:

1.2 TYPEID Obligatory attribute. the type of identifier is a reference to the specification HALF-VALUE LAYER r2. This element is composed of two attributes: - the root (root) which has as a value “2.16.840.1.113883.1.3” (OID of recording of models HL7). - The extension which has as a value “POCD_HD000040” which corresponds to the single identifier of the CDAr2 specification. Example: This element must obligatorily appear in an authority of document HALF-VALUE LAYER.

1.3 TEMPLATEID The CDAr2 documents in conformity with the guide of implementation present will indicate their conformity by the inclusion of the suitable element following TemplateId:

1.4 ID Obligatory attribute. The element “id” represents the single identifier of authority of the clinical document (UID). This UID identifies in a universal way this document, so that it can be divided and/or exchanged between various systems without there being collision risk of identifiers coming from the various systems. The element id consists of a root and an extension. Example: The root of identification within the framework of the documents produced for the RSN remains to be determined. Each medical document specified within the framework of the field of perinatality will be equipped with single Id.

1.5 CODE Obligatory attribute. The element code specifies the kind of the document such as a summary of exit, a report of consultation, synthesis of episode, etc The whole of the possible values carcatérisant the kind of the document results from nomenclature LOÏNC. The attributes necessary for this elements are it code and it codesystem. The code specifies the kind of the document coded by LOÏNC and the codesystem corresponds to the OID of organization LOÏNC. Attributes codeSystemName and displayName are optional and can be well informed at ends of legibility by the user. The codeSystemName must then take value “LOINC” and the displayName corresponds to the wording of the code like document within nomenclature LOINC. Examples: If the document is a note of consultation: If the document is a summary of episode:

1.6 EFFECTIVETIME Obligatory attribute. This element corresponds to the effective creation date of the document by the system of origin. If a new version comes to replace the current version, effectiveTime corresponds to the creation date of the new version. Examples: Interpreted like year/month/day/heure/mn/sec in the standard time, Interpreted like year/month/day/hour in the standard time, Reduced confidentiality

1.8 RECORDTARGET Obligatory attribute. The element recordTarget carry the data elements concerning the subject for which this document was carried out. In the majority of the cases, a clinical document is connected to only one recordTarget. However it is possible to associate several recordTarget a document in the case for example where this one concerns at the same time the mother and her child or in the case of a document concerning a whole of patients (of the twins for example). Example: In the following example, the root and extionsion off the id patient are supplied by the orgnization that is defining. The patient and its child name element, while optional per the diagram, may Be required by has business rule for has sensitive record to Be created. This is also true for the providerOrganization element and its children. Henry Levin Organization Name

1.9 AUTHOR Obligatory attribute. the element author represent the person or the system author of the clinical document. The elements wire time and assignedAuthor are necessary. It can exist several authors of the same document. If the whole of these actors endorses the responsibility for author of the totality of the document, it is necessary to reveal as many elements author that there are actors. If each actor endorses the responsibility for author of part of the document, it is necessary to reveal the element author on the level of the section concerned. In this case, the author attached to the section supplants the author declared on the level of at the head. Example: Organization Name

1.10 CUSTODIAN Obligatory attribute. The element custodian represent the organization which has in responsibility of manage the clinical document, it acts of the structure which produced this document. This organization is described in the element custodian/assignedCustodian/representedCustodianOraganization made up of under following obligatory elements: Id: single identifier of the organization, Name: name of this organization Addr: adrress Telecom: telephone co-ordinates. Example: <>Medical Past History< /title> There has off history Asthma< /content> Thus, the specification HALF-VALUE LAYER makes it possible to the actors of the exchange to manage the transition from not structured towards structured. In a document HALF-VALUE LAYER cohabit of the “narrative ” parts (part text) intended for posting, and of the structured “entries ”. A system temporarily unable to manage the structured data will be satisfied to post the data of the narrative part in a navigator (with the assistance or not of a style sheet). A system able to manage the structured data will have, moreover, access to all the detail of the coded data. This ambivalence of HALF-VALUE LAYER is essential to manage the transition from not structured towards structured. In the continuation of the document certain sections will be coded, others not. 2.2 STRUCTURING OF LEVEL 3: ENTRIES

2.2.1 ENTRIES OF LEVEL 3 DEDICATED TO THE MULTI-MEDIA POSTING OF INFORMATION In the future, the software trade of pediatry will have to be able to generate graphs (curved of growth, curves of weight, etc). The documents exchanged in the field of the perinatality will be likely to contain these graphs or of the simple images (echography type). The HALF-VALUE LAYER describes a particular structure of entry which makes it possible to manage these contents multimedia.

here is the multi-media contents in base64

2.2.2 ENTRIES OF LEVEL 3 DEDICATED TO THE EXPLOITTATION OF THE STRUCTURED DATA: Each section described in the documents of the perinatality field will be able to possibly contain a entry containing itself the coded part of the medical data carried by the section. If the narrative part of the section can be derived completion from the coded part, the attribute entry.typeCode will take value “DRIV”, if not it will take value “COMP”. The general rules applicable to all the entries of the field are as follows: - RG1: a entry is characterized by an element code composed of the attributes: O code : coding of a medical data, O codeSystem : identifier of the system of coding used to code the medical data, O codeSystemName: name of the system of coding, O dispalyName : the wording of the code of the medical data. - RG2 : transcoding of the medical information coded in various nomenclatures: O The element translation, within the entry, allows to code a transcoding of the medical data in another nomenclature of which a nomenclature “pivot”. - RG3: construction of the narrative part to leave the coded part: O The element originalText can be used like process of a simple and basic coding. Indeed, this element exists if the actor who generates information initially does not inform it in a coded form, but in a textual form. Coding can be carried out later, by a system or a user. O For example, during the creation of the document, the doctor can seize an allergy in the shape of a character string such that “asthma”. This information will be supplemented later by an other actor who will inform the code of the data “asthma” O The connection between the narrative part (text) and the coded part (entry) is established via the attribute reference element originalText on the level of the entry. This element refers to a local identifier with the file XML-CDA which is defined in the level of the narrative part of the document via the element . Example:

2.3.1 STRUCTURING OF LEVEL 2: LIST SECTIONS OF THE DOCUMENT The body of the document is consisted of the following sections: - Psychosocial context of the mother: O Socio-demographic information of the father and the mother, O Psychosocial context, - personal antecedents of the mother: O medical antecedents, O surgical antecedents, O gynéco-obstétricaux antecedents O other antecedents - family antecedents. (antecedents of the members of the family of the mother and the members of the family of the father) - habitus: dependence with the tobacco, dependence with alcohol, drug-addiction, etc - serology, - biometric data of the father and the mother. The body of the document will be composed of the various sections presented below, each section being coded by a code LOINC. Titrate Code The wording loinc card loinc Social context psycho 29762-2 SOCIAL HISTORY 0..1 Biometric data 8716-3 VITAL SIGNS 0..1 Personal antecedents 11322-5 HISTORY OFF GENERAL HEALTH 0..1 Medical antecedents 11348-0 HISTORY OFF PASTILLNESS 0..1 Surgical antecedents 47519-4 HISTORY OFF PROCEDURES 0..1 Gynéco-obstétricaux antecedents 11449-6 PREGNANT STATUS 0..1 Other antecedents 11329-0 GENERAL HISTORY 0..1 Family antecedents 10157-6 HISTORY OFF FAMILY MEMBER DISEASES 0..1 Addiction with alcohol/drug 18663-5 HISTORY OFF PRESENT ALCOHOL AND/OR 0..1 SUBSTANCE MISUSES Addiction with the tobacco 11366-2 HISTORY OFF TOBACCO USES 0..1 Serology 18733-6 Subsequent evaluation notes (attending physician) 0..1 Each section will be built according to the model general of a section describes before in this document.

2.3.2 STRUCTURING OF LEVEL 3: THE STRUCTURED PART

2.3.2.1 psychosocial context: 29762-2 (SOCIAL HISTORY) This section identifies information of a social nature, personal (life style), psychological, as well as administrative information such as the marital statute, which can have an impact on the follow-up of the patient by the medical team. This section is optional on level 2 and level 3. The marital statute as all administrative information will be also coded on the level of at the head the HALF-VALUE LAYER and possibly on level 3 For example, it marital statute will be coded on the level of at the head by ClinicalDocument/recordTarget/patientRole/patient/maritalStatusCode. The administrative infos of the psychosocial context are as follows: at the head or coding on the Social level of the section History on the model of Family History (regrouping by organizer of information by member of the family: father, mother). The whole of this information are not described in the header HALF-VALUE LAYER, we will thus code them on the level of the section “Social History” of the body of the document. - family circumstances, - family way of life, - nationality (father and mother), - geographical origin (father and mother), - level of studies (father and mother), - profession (father and mother), - resources of the mother, - Social Security cover of the mother The medical infos are as follows: - situation requiring a social accompaniment, - situation presenting a risk, - important events occurred during the pregnancy This section will be coded by means of the entity who allows to gather the whole of the data of the psychosocial context. An element will be used for each actor (the patient and its spouse). This element will be possibly connected to the beacon if this information refers to the spouse of the patient. Implicitly, in the case where entity misses, the observations of the psychosocial type described on the level of the entity correspond to the patient. Each information quoted above will be coded by means of an element . L Card Relative/element Attribute Been worth Comments v L Element of level 2 1 [1..1] section/templateId root 2.16.840.1.113883.10.20.15 Social history section template 1.3.6.1 .4.1.19376.1.5.3.1.3.16 social history section for this document shall Be has has conforming social off history section CCC (2.16.840.1.113883.10.20.15) and shall Be has conforming social off history section this guide (1.3.6.1 . 4.1.19376.1.5.3.1.3.16) 1 [1..1] section/code code 29762-2 Code identifying the psychosocial context of the patient (way of life, beliefs, codeSystem 2.16.840.1.113883.6.1 practices of work…)as well as the factors codeSystemName LOINC of risks of the patient displayName 1 [1..1] section/ Titrate section readable by human: “factors of risks” 1 [1..1] section/text Contents readable by human of the section (left narrative) Elements of level 3 1 [0. .n] section/entry typeCode DRIV Described the way in which the narrative part of the section is built. The narrative part is deduced from the codified part 2 [1..2] entry/organizer moodCode EVN Fixed by HL7 classCode CLUSTER Values fixed by HL7 3 [1..1] organizer/templateId root PCC codes? nondefinite Social History Organizer Template OID specific to RSN Identification of the model organizer of the social type history (Social History organizer template) 3 [1..1] organizer/statusCode code “completed” fixed Subject participation used yew the subject differs from the recordTarget off the header (e.g. social history information butt the husband) 3 [0..1] organizer/subject typeCode SBJ 4 [0..1] subject/relatedSubject classCode PRS 5 [1..1] relatedSubject/code code HUSB HL7v3 vocabulary (RoleCode) is used to qualify the husband codeSystem 2.16.840.1.113883.5.111 codeSystemName RoleCode displayName “Husband” 6 [0..1] relatedSubject/subjectPerson classCode PSN Extension HALF-VALUE LAYER R2 described in section family history of the CCC * is necessary it to name the spouse on this level or the level of the header? 7 [0..1] subjectPerson/name * 7 [0..1] subjectPerson/birthTime been worth * 7 [0..1] subjectPerson/administrativeGenderCode code M codeSystem 2.16.840.1.113883.5.111 codeSystemName AdministrativeGender displayName Male Content off the Social History Organizer: any number off SocialHistoryObservation 3 [1..*] organizer/component typeCode COMP 4 [1..1] component/observation moodCode EVN Fixed by HL7 classCode OBS 5 [0..1] observation/templateId root 2.16.840.1.113883.10.20.1.33 Social History observation template 2.16.840.1.113883.10.20.1.4.13.4 The relative off this template has simple compatible observation with the CCC template (2.16.840.1.113883.10.20.1.33) 5 [0..1] observation/id root ‘ ‘ extension ‘ ‘ 5 [0..1] observation/code code Cf lists nomenclatures used by this Identification of the system of coding of section the demographic or psychosocial data codeSystem OID RSN (for administrative dated) but 2.16.840.1.113883.6.96 (for medical dated) codeSystemName DPERINAT RSN gold SNOMED- CT displayName 5 [1..1] observation/statusCode code Completed (fixed) 5 [0..1] observation/effectiveTime Been worth Low For example, the period during the patient Been worth Hight was married 5 [0..1] been worth observation/ xsi: type PQ: physical quantity gold This social element carryforwards the CD: coded been worth gold been worth associated with the history, in the box the dated is coded ANY PQ: {xxx} /d or/wk gold /a CD: coded been worth with appropriate vocabulary 5 [0..1] Been worth observation/ xsi: type ST This social element carryforwards the been worth associated with the history, in the box the dated is text 5 [0..1] Been worth observation/ xsi: type been worth BL true or false Precarious conditions of lodging Occupation followed during the pregnancy Table 1: section Social History List nomenclatures associated with this section: Family circumstances: code SITFAM Code the wording 0 Unknown 1 Single person 2 Married (E) 3 divorced 6 pacs Family way of life: code MODFAM Code the wording 0 Unknown 1 Only 2 In couple 3 Other Nationality: code NAT Code the wording 0 Unknown 1 Frenchwoman 17 The EEC 18 Except the EEC 2 Other Geographical origin: code ORIGEO Code the wording 0 Unknown 1 Metropolitan France 2 Northern Europe 3 Europe of the south 4 North Africa 5 Africa 6 Dom-Tom 7 Asia 8 Other Level of studies: code OFFAL Code the wording 0 Unknown 1 Not provided education for 2 Primary education 3 College (6°- 3°) - BEP - CAPE 4 College 5 Higher education Profession: code TEACHER (extracted nomenclature INSEE) Code the wording 0 Unknown 10 farmer 20 craftsman 30 Tally, liberal profession 40 Intermediate profession 51 Employee (E) of the public office or the companies 52 Employee (E) of trade 61 Personnel of service 62 Ouvirer (E) 80 Nobody not having never worked, student Social Security cover: code COUVSOC Code the wording 0 Unknown 1 Social security 2 Secu + mutual 3 CMU 4 HEART 5 other 6 none The concept of conditions of lodging (precarious yes/not) is attached to this concept of Social Security cover. Resources: code LMBO Code the wording 0 work 1 RMI 2 Allowances unemployment 3 API 4 none 5 other Events occurred during the pregnancy: code EVN Code the wording 0 Separation or divorce 1 Family death 2 Job loss 3 other Situation at the risk: code RISQ Code the wording 0 Risk as regards the social aspects 1 Risk on the psychological level 2 As regards the social and psychological aspects ******************************************************* Social History section ******************************************************** -->

2.3.6 GYNÉCO-OBSTÉTRICAUX ANTECEDENTS 11449-6 Uncoded section, the narrative part is indicated starting from the element text contents in the coded part. section 10162-6 (PREGNANCY HISTORY SECTION) L Card Relative/element Attribute Been worth Comments v L Element of level 2 1 [0..1] section/templateId root 1.3.6.1 .4.1.19376.1.5.3.1.1.5.3.4 PCC Pregnancy history section template 1 [1..1] section/code code 10162-6 Code identifying the section of the gynéco-obstétricaux antecedents. codeSystem 2.16.840.1.113883.6.1 This operative section lists and codeSystemName LOINC describes the diagnosis and therapeutic displayName HISTORY OFF PREGNANCIES procedures in the past 1 [1..1] section/ Titrate section readable by human: “previous gynéco-obstétricaux” 1 [1..1] section/text Contents readable by human of the section (left narrative) Elements of level 3 1 [0. .n] section/entry typeCode DRIV Described the way in which the narrative part of the section is built. 2 [1..1] entry/observation moodCode EVN Fixed by HL7 classCode OBS Values fixed by HL7 3 [1..1] /templateId observation root 1.3.6.1 .4.1.19376.1.5.3.1.4.13 Pregnancy Template Observation 1.3.6.1 .4.1.19376.1.5.3.1.4.13.5 p320 PCC 3 [1..1] /id observation root extension 3 [1..1] /code observation code Code identifying the code of the observation, by means of a local codeSystem OID RSN + ident nomenc nomenclature (local use d'1 nomenc codeSystemName ANTCGYNECO rather than Loinc bus difficulty of coding the age of the 1° rules and displayName regularity of the cycles. : 8678-5 : menstrual status 8665-2 : date last menstrual period p321 PCC age of the 1° rules? Regularity of the cycles? (menstrual status?) 3 [1..1] /text observation Been worth reference #xxx Reference to the descriptive text of the observation 3 [1..1] /statusCode observation code completed 3 [0..1] /effectiveTime observation been worth Date to which the observation intervened 3 [0..1] /value observation Xsi: type CD been worth Value of the code in nomenclature ANTCGYNECO Gynaecological pathologies to announce are as follows : Genital herpes Lesions will intra epithelial Cicatricial uterus of gynaecological origin Fibrome untreated Genital malformation other ******************************************************** Pregnancy history section ********************************************************

Nun Nun1973 -

[1] HALF-VALUE LAYER r2: Clinical Document Structures release2 [2] Definition of at the head the HALF-VALUE LAYER French r2-Specifications