IHE Quality, Research and Public Health Technical Framework Supplement. Mother and Child Health (MCH) Draft for Public Comment

Transcription

1 Integrating the Healthcare Enterprise 5 IHE Quality, Research and Public Health Technical Framework Supplement 10 Mother and Child Health (MCH) Draft for Public Comment 15 Date: June 04, 2010 Author: Ana Estelrich qrph@ihe.net Copyright 2010: IHE International

2 Foreword This is a supplement to the forthcoming IHE Quality, Research and Public Health Technical Framework. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks. This supplement is submitted for Public Comment between June 4 and July 6, Comments are invited and may be submitted to the IHE forums at In order to be considered in development of the Trial Implementation version of the supplement comments must be received by July 06, Please use the Public Comment Template provided in the thread and submit comments by posting the completed template as an attachment to a Reply or New Thread. This supplement describes changes to the existing technical framework documents and where indicated amends text by addition (bold underline) or removal (bold strikethrough), as well as addition of large new sections introduced by editor s instructions to add new text or similar, which for readability are not bolded or underlined. Boxed instructions like the sample below indicate to the Volume Editor how to integrate the relevant section(s) into the relevant Technical Framework volume: Replace Section X.X by the following: General information about IHE can be found at: Information about the IHE Quality, Research and Public Health can be found at: Information about the structure of IHE Technical Frameworks and Supplements can be found at: and The current version of the IHE Technical Framework can be found at: Rev Copyright 2010: IHE International

3 CONTENTS Introduction... 4 Profile Abstract... 4 Open Issues and Questions... 4 Closed Issues... 5 Volume 1 Integration and Content Profiles... 6 Glossary Mother and Child Integration Profile Mother and Child Health Content Profile Actors/ Transactions Mother and Child Health Content Profile Options Grouping Content Binding with RFD Mother and Child Health Process Flow Use-Case 1: Birth Certificate Use-case 2: Early childhood health certificates Health certificates MCH Security Considerations MCH Specific Risk Considerations Volume 2 Transactions and Content Specifications Preface to Volume Intended Audience Related Information for the Reader How this Document is Organized Conventions Used in this Volume The Generic IHE Transaction Model Copyright Permissions How to Contact Us Introduction Relationship to Standards Relationship to Product Implementations Relation of this Volume to the Technical Framework Content Modules Transactions Retrieve Form for Data Capture Transactions IHE MCH Bindings Namespaces and Vocabularies IHE Format Codes IHE ActCode Vocabulary IHE RoleCode Vocabulary Content Specifications Conventions Folder Content Modules QRPH MCH Content Modules Document Content Modules Rev Copyright 2010: IHE International

4 IHE Technical Framework Supplement - Mother and Child Health (MCH) CDA Header Content Modules CDA Section Content Modules CDA or HL7 Version 3 Entry Content Modules QRPH HBS MCH Value Sets QRPH MCH HBS History of Past llness Value Set QRPH MCH HBS Pregnancy Observation Value Set QRPH MCH HBS History of Tobacco Use Value Set QRPH MCH HBS Coded Social History Observation Value Set QRPH MCH HBS Coded Social History Value Set QRPH MCH HBS List of Surgeries Value Set QRPH MCH HBS Prenatal Procedures and Intervention Value Set QRPH MCH HBS Prenatal Events Value Set QRPH MCH HBS Labor and Delivery Value Set QRPH MCH HBS Visit Summary Value Set QRPH MCH HBS Newborn Delivery Information Value Set QRPH MCH CGS Coded Social History Value Set QRPH MCH CGS History of Past Illness Value Set QRPH MCH CGS History of Infection Value Set QRPH MCH CGS Immunization Value Set QRPH MCH CGS Vital Signs Value Set QRPH MCH CGS Neurological System Value Set QRPH MCH CGS Heart Observation Value Set QRPH MCH CGS Respiratory System Value Set QRPH MCH CGS Abdomen Observation Value Set QRPH MCH CGS Endocrine System Value Set QRPH MCH CGS Genitalia Observation Value Set QRPH MCH CGS Musculoskeletal System Value Set QRPH MCH CGS Lymphatic System Value Set QRPH MCH CGS Integumentary System Value Set QRPH MCH CGS Eye Observation Value Set QRPH MCH CGS Ears Observation Value Set QRPH MCH CGS Mouth, Throat, and Teeth Observation Value Set QRPH MCH CGS Psychomotor Subsection Value Set QRPH MCH CGS Functional Status Assessment Value Set Value Sets Used in National Extension QRPH MCH HBS Parents (US Specific) Value Set QRPH MCH HBS Child (French Specific) Value Set QRPH MCH CGS Child Care (French specific) Value Set QRPH MCH CGS Parents (US specific) Value Set Rev Copyright 2010: IHE International

5 135 Introduction This supplement describes two content profiles that will be used as part of the Mother and Child Content profile. This supplement includes material that describes the motivation for the Mother and Child profile Vital Records birth certificates and fetal death reports include important demographic, medical and key information about the antepartum period, the labor and delivery process and the newborn/fetal death 1. Much of the medical and health information collected for the birth certificate and fetal death report can be pre-populated with information already available in the EHR. A responsible HCP can complete the remainder of the information. These data may then be used by public health agencies to track maternal and infant health to target interventions for at risk populations. Profile Abstract This profile describes the content to be used in automating the data captured for vital records purposes such as for the U.S. Standard Certificate of Live Birth and the U.S. Standard Report of Fetal Death 2. Select vital records data may be captured in an EHR at the point of care or contact with the patient instead of retrospectively. This select information may pre-populate the vital records systems and potentially other stakeholder information systems for birth and fetal death events via the mechanism provided by the Request Form for Data Capture (RFD) integration profile. The MCH profile uses transactions and content modules defined in other IHE profiles to provide interoperable data exchange. The information is represented by two content profiles in MCH: 1. Health at Birth Summary (HBS) content profile containing a summary of all the information impacting on the newborn s health status evaluation as presented in the birth certificate. 2. Child Growth Summary (CGS) content profile representing information about the child s development (medical and social conditions) that can be submitted to health authorities for possible intervention or general epidemiological studies. 165 Open Issues and Questions 1. A common, standardized vocabulary and datasets is needed so that the data aggregation can be achieved. 2. A form archiver actor must be considered. When forms are partially filled, the data source actor should have the possibility to store this form and complete it later. 1 In some countries the birth certificate contains just the patient demographics and the medical information is recorded in separate early childhood health certificates produced at different times. 2 These can also be early childhood health certificates in other countries such as France. Rev Copyright 2010: IHE International

6 IHE Technical Framework Supplement - Mother and Child Health (MCH) 3. Not all the information might be present, depending on the existence of an antepartum record (APR) and a labor and delivery record (LDR). 4. The birth place does not seem to be represented in either the header information present in the PCC XPRH Content Header Module. This will result in a CP in the Final Text for PCC. 5. Need observation entry for the labor and delivery section for the mother for observation for the labor proces. 180 Closed Issues 1. The data elements present in this profile are taken form the French health certificates and the US standard birth certificate. National extensions can be made to separate the data elements that are specific to each country. 2. The first certificate belongs to the mother and to the newborn. The information captured about the newborn is the immediate information in the birthing facility and it is present in the PCC LDR Supplement. Rev Copyright 2010: IHE International

7 Volume 1 Integration and Content Profiles Glossary Apgar score Apgar score is a systematic measure for evaluating the physical condition of the infant at specific intervals following birth. It is a score that assesses the general physical condition of a newborn infant by assigning a value of 0, 1, or 2 to each of five criteria: heart rate, respiratory effort, muscle tone, skin color, and response to stimuli. The five scores are added together, with a perfect score being 10. Apgar scores are usually evaluated at one minute and five minutes after birth. If the 5 minute Apgar score is < 6 then additional Apgar scores at 10 minutes are required. 195 APS Antepartum Summary content profile the Supplement for Trial Implementation. APR Antepartum Record content profile 200 ATNA Audit Trail and Node Authentication. IT Infrastructure profile, described in ITI TF-1:9, and published in the ITI Technical Framework, version Antibiotic Antibiotic is a chemotherapeutic agent that inhibits or abolishes the growth of micro-organisms, such as bacteria, fungi, or protozoans. 210 Anorexia Anorexia nervosa is a psychiatric illness that describes an eating disorder characterized by extremely low body weight and body image distortion with an obsessive fear of gaining weight. 215 Asthma Asthma is a chronic (long-lasting) inflammatory disease of the airways. In those susceptible to asthma, this inflammation causes the airways to narrow periodically. This, in turn, produces wheezing and breathlessness, sometimes to the point where the patient gasps for air. 220 Breech presentation Breech presentation is a presentation of the fetal buttocks or feet in labor; the feet may be alongside the buttocks (complete breech presentation); the legs may be extended against the trunk and the feet lying against the face (frank breech presentation); or one or both feet or knees may be prolapsed into the maternal vagina (incomplete breech presentation). Rev Copyright 2010: IHE International

8 225 IHE Technical Framework Supplement - Mother and Child Health (MCH) Cesarean section Cesarean section, or C-section, is an extraction of the fetus, placenta, and membranes through an incision in the maternal abdominal and uterine walls Cephalic presentation Cephalic presentation is the presentation of part of the fetus, listed as vertex, occiput anterior (OA), occiput posterior (OP). Cerebral palsy Cerebral palsy describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to nonprogressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behaviour, by epilepsy, and by secondary musculoskeletal problems. 240 Chromosome abnormalities Chromosome abnormalities consist of any change occuring in the structure or number of any of the chromosomes of a given species. In humans, a number of physical disabilities and disorders are directly associated with aberrations of both the autosomes and the sex chromosomes, including Down, Turner's, and Kleinfelter's syndromes. 245 Cleft lip Cleft lip with or without cleft palate is the incomplete closure of the lip. It may be unilateral, bilateral, or median. 250 Cleft palate Cleft palate is an incomplete fusion of the palatal shelves. It may be limited to the soft palate, or may extend into the hard palate Congenital heart defect Congenital heart defect (CHD) is a defect in the structure of the heart and great vessels of a newborn. Obstruction defects. CHD can be classified as: Obstruction defects occur when heart valves, arteries, or veins are abnormally narrow or blocked. Septal defects, for defects concerning the separation between left heart and right heart Cyanotic defects, including persistent truncus arteriosus, total anomalous pulmonary venous connection, tetralogy of Fallot, transposition of the great vessels, and tricuspid atresia. 265 Congenital hip dysplasia Congenital hip dysplasia is a hip joint malformation present at birth, thought to have a genetic component Clinical Hip dislocation, asymmetry of legs and fat folds; congenital hip dislocation may be asymptomatic and must be diagnosed by physical examination. Rev Copyright 2010: IHE International

9 270 Cystic fibrosis Cystic fibrosis (CF) is an inherited disease that affects the lungs, digestive system, sweat glands, and male fertility. Its name derives from the fibrous scar tissue that develops in the pancreas, one of the principal organs affected by the disease. 275 CT Consistent Time. IT Infrastructure profile, described in ITI TF-1:7, and published in the ITI Technical Framework, version 6.0. DSG Document Digital Signature. IT Infrastructure profile, described in ITI TF-3:4, and published the ITI Supplement for Trial Implementation. 280 Down syndrome Down syndrome or trisomy 21 is a genetic disorder caused by the presence of all or part of an extra 21st chromosome. 285 Eczema Eczema is an acute or chronic noncontagious inflammation of the skin, characterized chiefly by redness, itching, and the outbreak of lesions that may discharge serous matter and become encrusted and scaly Endocrine disorder Endocrine system is an integrated system of small organs which involve the release of extracellular signaling molecules known as hormones. Hypofunction of endocrine glands can occur as result of loss of reserve, hyposecretion, agenesis, atrophy or active destruction. Hyperfunction can occur as result of hypersecretion, loss of suppression, hyperplastic or neoplastic change, or hyperstimulation. Epidural aneshesia Epidural anesthesia is a regional anesthetic that is administered to the mother to control the pain of labor. It includes delivery of the agent into a limited space with the distribution of the analgesic effect limited to the lower body. Esophageal atresia Congenital esophageal atresia (EA) represents a failure of the esophagus to develop as a continuous passage. Instead, it ends as a blind pouch. Food allergies Food allergies are the body's abnormal responses to harmless foods; the reactions are caused by the immune system's reaction to some food proteins. Rev Copyright 2010: IHE International

10 310 Gastroesophageal reflux Gastroesophageal reflux is the reflux of the stomach and duodenal contents into the esophagus. 315 Gastroschisis Gastroschisis is an abnormality of the anterior abdominal wall, lateral to the umbilicus, resulting in herniation of the abdominal contents directly into the amniotic cavity. It is differentiated from omphalocele by the location of the defect and the absence of a protective membrane. 320 General aneshesia General anesthesia is the induction of a state of unconsciousness with the absence of pain sensation over the entire body, through the administration of anesthetic drugs. It is used during certain medical and surgical procedures Genitourinary tract Genitourinary tract is the organ system of all the reproductive organs and the urinary system. These are often considered together due to their common embryological origin. Gestational age (weeks of amenorrhea) Gestational age is the number of weeks elapsed between the first day of the last normal menstrual period and the date of delivery. Gestational diabetes Gestational diabetes is a condition that occurs during pregnancy. Like other forms of diabetes, gestational diabetes involves a defect in the way the body processes and uses sugars (glucose) in the diet. Hearing test Hearing function test, pure tone audiometry Audiology Any test that measures hearing or quantifies hearing loss; sound is perceived by intensity loudness and by tone; both are measured in HTs, as is the ability to hear sound through air air conduction and bone bone conduction. Heart malformation Heart malformation or congenital heart defect (CHD) is a defect in the structure of the heart and great vessels of a newborn. Most heart defects either obstruct blood flow in the heart or vessels near it or cause blood to flow through the heart in an abnormal pattern, although other defects affecting heart rhythm can also occur. Hemoglobin disease Hemoglobin is produced by genes that control the expression of the hemoglobin protein. Defects in these genes can produce abnormal hemoglobins and anemia, which are conditions termed "hemoglobinopathies". Abnormal hemoglobins appear in one of three basic circumstances: Rev Copyright 2010: IHE International

11 IHE Technical Framework Supplement - Mother and Child Health (MCH) Structural defects in the hemoglobin molecule. Diminished production of one of the two subunits of the hemoglobin molecule. Abnormal associations of otherwise normal subunits. Hydrocephalus Hydrocephalus is the abnormal accumulation of cerebrospinal fluid (CSF) in the ventricles, or cavities, of the brain. This may cause increased intracranial pressure inside the skull and progressive enlargement of the head, convulsion, and mental disability. 360 Immunoglobulin Immunoglobulin is aconcentrated preparation of gamma globulins, predominantly IgG, from a large pool of human donors; used for passive immunization against measles, hepatitis A, and varicella and for replacement therapy in patients with immunoglobulin deficiencies. 365 Induction of labor Induction of labor is the initiation of uterine contractions by medical and/or surgical means for the purpose of delivery before the spontaneous onset of labor (i.e., before labor has begun). In-utero transfer 370 Intra-uterine growth retardation (IUGR) Intrauterine growth retardation (IUGR) occurs when the unborn baby is at or below the 10th weight percentile for his or her age (in weeks). 375 Intubation Tracheal intubation is the placement of a flexible plastic tube into the trachea to protect the patient's airway and provide a means of mechanical ventilation. 380 LDHP Labor and Delivery Admission History and Physical content profile. 385 LDR Labor and Delivery Record content profile, the PCC Supplement for Trial Implementation. LDS Labor and Delivery Summary content profile, part of the Labor and Delivery Record profile. PCC Supplement for Trial Implementation. Rev Copyright 2010: IHE International

12 390 IHE Technical Framework Supplement - Mother and Child Health (MCH) MDS Maternal Discharge Summary content profile, part of the Labor and Delivery Record profile. PCC Supplement for Trial Implementation. 395 Meningomyelocele Meningomyelocele is a herniation of the meninges and spinal cord tissue Neural tube defects Neural tube defect will occur in human embryos if there is an interference with the closure of the neural tube. Nonvertex Presentation Nonvertex presentation is the presentation of other than the upper and back part of the infant s head. 410 Nuchal translucency scan Nuchal translucency scan is an ultrasonographic prenatal screening scan to help identify higher risks of Down syndrome in a fetus. The scan is carried out at weeks pregnancy and assesses the amount of fluid behind the neck of the fetus. Fetuses at risk of Down tend to have a higher amount of fluid around the neck Omphalocele Omphalocele is a defect in the anterior abdominal wall, accompanied by herniation of some abdominal organs through a widened umbilical ring into the umbilical stalk. PDQ Patient Demographics Query. IT Infrastructure profile, described in ITI TF-1:8, and published in version 6.0 of the ITI Technical Framework. PIX Patient Identifier Cross-referencing. IT Infrastructure profile, described in ITI TF-1:5, and published in version 6.0 of the ITI Technical Framework Pre-eclampsia Pre-eclampsie is a disorder occurring during late pregnancy or immediately following parturition, characterized by hypertension, edema, and proteinuria. Also called toxemia of pregnancy. Preterm birthpreterm birth is a live birth of less than 37 completed weeks of gestation. Premature labor Premature labor describes the contractions of the uterus less than 37 weeks in a pregnancy. Rev Copyright 2010: IHE International

13 Presentation Presentation is the part of the fetus lying over the pelvic inlet; the presenting body part of the fetus Polymalformative syndrome Polymalformative syndrome is set of non-random birth defects deriving from the same cause. It involves multiple systems of the organism (eyes, ears, central nervous system, heart, musculoskeletal...). Its screening, mostly by clinical examination means, is systematically made at birth. RFD Request Form for Data Capture integration profile, the ITI Supplement for Trial Implementation. 445 Spina bifida Spina bifida is a herniation of the meninges and/or spinal cord tissue through a bony defect of spine closure Spinal aneshesia Spinal anesthesia or sub-arachnoidal block is a form of regional anesthesia involving the injection of local anaesthetic into the cerebrospinal fluid. Fetal deathfetal death is a death prior to the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy and which is not an induced termination of pregnancy. The death is indicated by the fact that after such expulsion or extraction, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of the voluntary muscles. Heartbeats are to be distinguished from fleeting respiratory efforts or gasps.. Metabolism disorder Metabolism disorders are disorders that affect chemical processes that take place in living organisms, resulting in growth, generation of energy, elimination of wastes, and other body functions as they relate to the distribution of nutrients in the blood after digestion. Ultrasound Ultrasound study is a radiologic study using sound waves used in the assessment of gestational age, size, growth, anatomy, and blood flow of a fetus or in the assessment of maternal anatomy and blood flow. Vaginal birth/spontaneous Rev Copyright 2010: IHE International

14 Vaginal birth/spontaneous birth is the delivery of the entire fetus through the vagina by the natural force of labor with or without manual assistance from the delivery attendant. 475 Vaginal birth with forceps Vaginal birth with forceps is the delivery of the fetal head through the vagina by the application of obstetrical forceps to the fetal head. 480 Vaginal birth with vacuum Vaginal birth with vacuum is the delivery of the fetal head through the vagina by the application of a vacuum cup or ventouse to the fetal head. Vertex Presentation Vertex presentation is the presentation of the upper or back part of the infant s head. 485 XDM Cross-Enterprise Document Media Interchange. IT Infrastructure profile, described in ITI TF-1:16, and published in version 6.0 of the ITI Technical Framework. 490 XDR Cross Enterprise Document Reliable Interchange. IT Infrastructure profile, described in ITI TF- 1:15, and published as a supplement for Trial Implementation. 495 XDS Cross-Enterprise Document Sharing. IT Infrastructure profile, described in ITI TF-1:10, and published in version 6.0 of the ITI Technical Framework. Rev Copyright 2010: IHE International

15 500 1 Mother and Child Integration Profile This profile describes the contents to be used in the pre-population and automatic submission of the child and maternal health information to public health agencies via the mechanism provided by the Request Form for Data Capture (RFD) integration profile. The Mother and Child (MCH) profile uses transactions and content modules defined in other IHE profiles to provide interoperable data exchange. 505 Note: The U.S. plans to limit the scope of data that may be pre-populated from an EHR for vital records purposes to a subset of the vital records data requirements. The initial goal will be to monitor and assess the quality of the data that will be exchanged between electronic health record and vital records systems and the quality of the process of information exchange. 510 The Mother and Child (MCH) content profile contains two content profiles, namely the: Health at Birth Summary (HBS) Child Growth Summary (CGS) 515 MCH describe the contents to be used in automating the submission of the child and maternal health information to public health agencies via the mechanism provided by the Request Form for Data Capture (RFD) integration profile. This new profile uses transactions and content modules defined in other IHE profiles to provide interoperable data exchange. Table Mother and Child - QRPH MCH Content profile dependencies Integration Profile Depends on Dependency Type Purpose HBS, CGS HBS, CGS HBS, CGS HBS, CGS HBS, CGS Retrieve Form for Data Capture (RFD) Audit Trail and Node Authentication (ATNA) Consistent Time (CT) Antepartum Record (APR) Labor and Delivery Record (LDR) Integration Profile The Form Filler snf the Form Manager actors shall be grouped with the ATNA Secured Node Actor The Form Filler and Form Manager actors shall be grouped with the Time Client Actor. Content profile Content profile Required to extract data existing in the EHR, prepopulate forms, and submit them to the interested organizations. Required to manage audit trail of exported PHI, node authentication, and transport encryption. Required to manage and resolve conflicts in multiple updates. This profile provides some of the content needed to pre-populate the forms in the MCH content profile. This profile provides some of the content needed to pre-populate the forms needed in MCH content profile. Rev Copyright 2010: IHE International

16 520 IHE Technical Framework Supplement - Mother and Child Health (MCH) 1.1 Mother and Child Health Content Profile This is background material providing motivation for the MCH profile Specific vital statistic data as well as medical data is collected by social services and public health organizations within the early years of the child s life in order to administer preventative/prophylactic measures, and perform epidemiological studies. The general physician, pediatrician, obstetrician, labor and delivery nurse and other hospital staff provide information for the certificates (such as birth certificates or health certificates), and in some cases throughout the very early childhood period. 3. The form(s) must be filled out as it is required by law in some countries because they are used as key-indicators of the child s health. The purpose of this profile is to describe the content and format to be used within the prepopulation data part of the Retrieve Form Request transaction from the RFD Integration Profile. It is expected that the Form Filler and Form Manager will implement the RFD transaction as specified in the RFD, and this profile does not include any additional constraints or extensions on the RFD implementation. 540 Actors/ Transactions There are two actors in this profile, the Content Creator and the Content Consumer. Content is created by a Content Creator and is to be consumed by a Content Consumer. The sharing or transmission of content from one actor to the other is addressed by the Retrieve Form [ITI-34] transaction of the RFD Integration Profile via the Pre-population argument, and it is out of scope for this profile. See section X.3.1 for the binding of the Mother and Child Health Profile Actors and the corresponding RFD Actors. 545 Figure Mother Child Health Actor Diagram 3 The birth certificate and the health certificates contain the same type of information. The difference is due to national extensions practices. Rev Copyright 2010: IHE International

17 550 IHE Technical Framework Supplement - Mother and Child Health (MCH) Mother and Child Health Content Profile Options Options that may be selected for this Content Profile are listed in the table X.2-1 along with the Actors to which they apply. Dependencies between options when applicable are specified in notes. Table Mother and Child - Actors and Options Actor Options Vol & Section Content Creator Health at Birth Option Vol. 2: Y Child Growth Health Option Vol. 2: Z Content Consumer Health at Birth Option Vol. 2: Y Child Growth Health Option Vol. 2: Z Grouping It is expected that the transfers of information will occur in an environment where the physician offices and hospitals have a coordinated infrastructure that serves the information sharing needs of this community of care. In the U.S., for example, the environment must include the states/jurisdictions, public health agencies and other vital registration stakeholders. Since MCH uses forms RFD will be used to provide information sharing. For more details on RFD, see the IHE IT Infrastructure Technical Framework. Content profiles may impose additional requirements on the transactions used when grouped with actors from other IHE Profiles. Content Binding with RFD The Retrieve Form for Data Capture Profile (RFD) provides a method for gathering data within a user s current application to meet the requirements of an external system. RFD supports the retrieval of forms by a Form Filler from a Form Manager using pre-population data sent from the Form Filler and then further describes display and completion of a form, and return of instance data from the Form Filler to the Form Receiver as well as optionally to a Form Archiver. The Mother and Child Health content profile will be bound to the Retrieve Form transaction [ITI- 34] described in RFD. The Content Creator actor shall be grouped with the RFD Form Filler Actor from RFD, and the Content Consumer Actor shall be grouped with the RFD Form Manager actor. The data from the Content Consumer shall be transmitted to the Content Consumer as prepopulation data via the Retrieve Form transaction. Note that since no other constraints are made on the RFD profile, the format of the actual forms, and the submission of the forms are out of scope for this profile. Mother and Child Health Process Flow The basic process flow is the transmission for pre-population data from the Data Source to the Data Consumer. Rev Copyright 2010: IHE International

18 Use-Case 1: Birth Certificate Sets of detailed specifications have been developed for collecting and reporting the items on the U.S. Standard Certificate of Live Birth and the U.S. Standard Report of Fetal Death. It is critical that all U.S. vital registration areas follow these standards to promote uniformity in data collection across registration areas. The best sources for specific data items are identified in the Birth Edit Specifications for the 2003 Revision of the U.S. Standard Certificate of Birth. Additionally, standard worksheets are used to enhance the collection of quality, reliable data. A common, standard form, entitled Mother s Worksheet for Child s Birth Certificate, has been established to identify information to be collected directly from the mother. The Facility Worksheet for the Live Birth Certificate was developed to identify information for which the best sources are the mother s and infant s medical records. The use of separate worksheets promotes a standardized collection across states. The "Patient's Worksheet for the Report of Fetal Death" and the "Facility Worksheet for the Report of Fetal Death" have also been established for the purpose of reporting fetal death information The Facility's Worksheet may serve as the primary source of data for an EHR. Select data may be used to pre-populate forms for vital records purposes. The birth records specialist plays an essential role in gathering the information and ensuring that all information is complete before transmission to the vital registration systems at the states/jurisdictional offices. The data is later transmitted to public health authorities and other vital records stakeholders. Example Forms: Mother s Worksheet Facility Worksheet U.S. Standard Certificate of Live Birth Use-case 2: Early childhood health certificates Health certificates This use case is given as an example on how public health functions in other countries. However this information could be used in monitoring pediatric health in general. Within the first week of birth, the patient will fill out half of a form pertaining to their social background (demographics, profession, level of education, social history and life habits). The physician will gather information from their EHR pertaining to: antepartum data such as prior pregnancy history, immunizations, details on labor and delivery, tests about pre-eclampsia, gestational diabetes, pre-existent hypertension, etc. details on the baby s clinical state at birth such as the APGAR score, pathological signs during the first week of life, abnormalities, etc. Two more health certificates are filled out in the same manner at nine months and at two years of age. If deemed necessary, the physician can recommend that a dedicated branch of the Social Rev Copyright 2010: IHE International

19 IHE Technical Framework Supplement - Mother and Child Health (MCH) Services intervene such as the Protection for Mother and Child (PMI - Protection maternelle infantile). The information is kept and when the two other health certificates are completed and received by PMI, they are sent to Public Health (InVS - Institut de Veille Sanitaire or the Institute of Health Surveillance). Example Forms: Health Certificate at Birth Health Certificate at Nine Months Health Certificate at Two Years Translation 630 Figure X.2-1. Basic Process Flow in Mother and Child Health Profile 635 MCH Security Considerations MCH is a content profile, and as such it is expected that the transfers of PHI will occur in an environment where the physician offices and hospitals have a coordinated infrastructure that serves the information sharing needs of this community of care. The appropriate risk assessment for that infrastructure must guide the security considerations when implementing the MCH profile. When an MCH Content Creator and Content Consumer are grouped with actors from IHE integration Rev Copyright 2010: IHE International

20 profiles (e.g. XDS, XDR), then the Security Considerations for the integration profiles will be used when implementing the MCH profile. 640 MCH Specific Risk Considerations 645 In addition to the usual considerations when sharing PHI, the MCH profile introduces a unique situation since the record is about two patients the mother and the newborn child. This introduces a risk for data integrity of the mother s and child s record. The mitigation for this risk is achieved by a properly configured system which handles the documentation of the delivery process and unambiguously allows the recording of the appropriate data for the mother and child. Rev Copyright 2010: IHE International

21 Volume 2 Transactions and Content Specifications Preface to Volume Intended Audience 655 The intended audience of this document is: Technical staff of vendors planning to participate in the IHE initiative IT departments of healthcare institutions Experts involved in standards development Anyone interested in the technical aspects of integrating healthcare information systems Related Information for the Reader The reader of volume 2 should read or be familiar with the following documents: Volume 1 and Volume 2 of the Audit Trail and Node Authentication (ATNA) Integration Profile documented in the ITI Infrastructure Technical Framework (See Volume 1 and Volume 2 of the Consistent Time (CT) Integration Profile documented in the ITI Infrastructure Technical Framework (See Retrieve Form for Data Capture (RFD) ITI Supplement for Trial Implementation (See Volume 1 and Volume 2 of the PCC Technical Framework Revision 4.0. (See Antepartum Record (APR) PCC Supplement for Trial Implementation (See Labor and Delivery Record (LDR) PCC Supplement for Trial Implementation (See CDA Content Modules PCC Supplement for Trial Implementation (See HL7 Clinical Document Architecture Release 2: Section 1, CDA Overview. Care Record Summary Implementation Guide for CDA Release 2 (US Realm): Section 1. HL7 Implementation Guide: CDA Release 2 Continuity of Care Document (CCD) HL7 Implementation Guide for CDA Release 2: History and Physical (H&P) Notes (U.S. Realm) Birth Edit Specifications for the 2003 Revision of the U.S. Standard Certificate of Birth Rev Copyright 2010: IHE International

22 Fetal Death Edit Specifications for the 2003 Revision of the U.S. Standard Report of Fetal Death How this Document is Organized Section 1 is the preface, describing the intended audience, related resources, and organizations and conventions used within this document. Section 2 provides an overview of the concepts of IHE actors and transactions used in IHE to define the functional components of a distributed healthcare environment. Section 3 defines transactions in detail, specifying the roles for each actor, the standards employed, the information exchanged, and in some cases, implementation options for the transaction. Section 4 defines a set of payload bindings with transactions. Section 5 defines the namespaces and vocabularies that are used in this supplement. Section 6 defines the content modules that may be used in transactions Conventions Used in this Volume This document has adopted the following conventions for representing the framework concepts and specifying how the standards upon which the IHE Technical Framework is based should be applied. The Generic IHE Transaction Model Transaction descriptions are provided in section 3. In each transaction description, the actors, the roles they play, and the transactions between them are presented as use cases. The generic IHE transaction description includes the following components: Scope: a brief description of the transaction. Use case roles: textual definitions of the actors and their roles, with a simple diagram relating them, e.g.: Actor ABC Actor DEF Transaction Name 710 Figure Use Case Role Diagram Referenced Standards: the standards (stating the specific parts, chapters or sections thereof) to be used for the transaction. Rev Copyright 2010: IHE International

23 Interaction Diagram: a graphical depiction of the actors and transactions, with related processing within an actor shown as a rectangle and time progressing downward, similar to: Rev Copyright 2010: IHE International

24 Figure Interaction Diagram The interaction diagrams used in the IHE Technical Framework are modeled after those described in Grady Booch, James Rumbaugh, and Ivar Jacobson, The Unified Modeling Language User Guide, ISBN Simple acknowledgment messages are omitted from the diagrams for brevity. Message definitions: descriptions of each message involved in the transaction, the events that trigger the message, its semantics, and the actions that the message triggers in the receiver Copyright Permissions Health Level Seven, Inc., has granted permission to the IHE to reproduce tables from the HL7 standard. The HL7 tables in this document are copyrighted by Health Level Seven, Inc. All rights reserved. Material drawn from these documents is credited where used. How to Contact Us IHE Sponsors welcome comments on this document and the IHE initiative. They should be directed to the discussion server at or to: Lisa Spellman Senior Director of Informatics 230 East Ohio St., Suite 500 Chicago, IL Rev Copyright 2010: IHE International

25 Introduction This document, the QRPH Mother and Child Supplement defines specific implementations of established standards used in this field. These are intended to achieve integration goals that promote appropriate exchange of medical information to coordinate the optimal patient care among care providers in different care settings. It is expanded annually, after a period of public review, and maintained regularly through the identification and correction of errata. The latest version of the document is always available via the Internet at where the technical framework volumes and supplements for trial implementation specific to the various healthcare domains addressed by IHE may be found. The other domains within the IHE initiative also produce Technical Frameworks within their respective areas that together form the IHE Technical Framework. Currently, the following IHE Technical Framework(s) are available: IHE Cardiology Technical Framework IHE Laboratory Technical framework IHE IT Infrastructure Technical Framework IHE Patient Care Coordination Technical Framework IHE Radiology Technical Framework Where applicable, references are made to other technical frameworks. For the conventions on referencing other frameworks, see the preface of this volume. 2.1 Relationship to Standards The IHE Technical Framework identifies functional components of a distributed healthcare environment (referred to as IHE actors), solely from the point of view of their interactions in the healthcare enterprise. At its current level of development, it defines a coordinated set of transactions based on standards (such as HL7, IETF, ASTM, DICOM, ISO, OASIS, etc.) in order to accomplish a particular use case. As the scope of the IHE initiative expands, transactions based on other standards may be included as required. Each transaction may have as its payload one or more forms of content, as well as specific metadata describing that content within the transaction. The specification of the payload and metadata about it are the components of a Content Integration Profile. The payload is specified in a Content Module, and the impacts of any particular payload on a transaction are described within a content binding. The payloads of each transaction are also based on standards (such as HL7, IETF, ASTM, DICOM, ISO, OASIS, etc.), again, in order to meet the needs of a specific use case. In some cases, IHE recommends selection of specific options supported by these standards. However, IHE does not introduce technical choices that contradict conformance to these standards. If errors in or extensions to existing standards are identified, IHE's policy is to report them to the appropriate standards bodies for resolution within their conformance and standards evolution strategy. IHE is therefore an implementation framework, not a standard. Conformance claims for products must still be made in direct reference to specific standards. In addition, vendors who have Rev Copyright 2010: IHE International

26 IHE Technical Framework Supplement - Mother and Child Health (MCH) implemented IHE integration capabilities in their products may publish IHE Integration Statements to communicate their products' capabilities. Vendors publishing IHE Integration Statements accept full responsibility for their content. By comparing the IHE Integration Statements from different products, a user familiar with the IHE concepts of actors and integration profiles can determine the level of integration between them. See ITI TF-1: Appendix C for the format of IHE Integration Statements. 2.2 Relationship to Product Implementations The IHE actors and transactions described in the IHE Technical Framework are abstractions of the real-world healthcare information system environment. While some of the transactions are traditionally performed by specific product categories (e.g. HIS, Clinical Data Repository, Electronic Health record systems, Radiology Information Systems, Clinical Information Systems or Cardiology Information Systems), the IHE Technical Framework intentionally avoids associating functions or actors with such product categories. For each actor, the IHE Technical Framework defines only those functions associated with integrating information systems. The IHE definition of an actor should therefore not be taken as the complete definition of any product that might implement it, nor should the framework itself be taken to comprehensively describe the architecture of a healthcare information system. The reason for defining actors and transactions is to provide a basis for defining the interactions among functional components of the healthcare information system environment. In situations where a single physical product implements multiple functions, only the interfaces between the product and external functions in the environment are considered to be significant by the IHE initiative. Therefore, the IHE initiative takes no position as to the relative merits of an integrated environment based on a single, all-encompassing information system versus one based on multiple systems that together achieve the same end. 2.3 Relation of this Volume to the Technical Framework The IHE QRPH domain does not have yet a published technical framework Content Modules This supplement uses as content modules the base standard, CDA Release 2.0, with the observation that other standards are used in other QRPH profiles such as CDISC. Underneath each standard, the content modules are organized using a very coarse hierarchy inherent to the standard. So for CDA Release 2.0 the modules are organized by document, header, section, entry, and value sets elements. Each content module can be viewed as the definition of a "class" in software design terms, and has associated with it a name. Like "class" definitions in software design, a content module is a "contract", which is defined in terms of constraints that must be obeyed by instances of that content module. Each content module has a name, also known as its template identifier. The template identifiers are used to identify the contract agreed to by the content module. The QRPH Technical Committee is responsible for assigning the template identifiers to each content module. Like classes, content modules may inherit features of other content modules of the same type (Document, Section or Entry) by defining the parent content module that they inherit from. They may not inherit features from a different type. Although information in the CDA Header is in a Rev Copyright 2010: IHE International

27 IHE Technical Framework Supplement - Mother and Child Health (MCH) different location that information in a CDA Entry, these two content modules are considered to be of the same type, and so may inherit from each other when necessary. This supplement uses the convention that a content module cannot have more than one parent (although it may have several ancestors). This is similar to the constraint in the Java programming language, where classes can derive from only one parent. This convention is not due to any specific technical limitation of the technical framework, but does make it easier for software developers to implement content modules. Each content module has a list of data elements that are required (R), required if known (R2), and optional (O). The presentation of this information varies with the type of content module, and is described in more detail below. Additional data elements may be provided by the sender that are not defined by a specific content module, but the receiver is not required to interpret them. Required data elements must always be sent. Data elements that are required may under exceptional circumstances have an unknown value (e.g., the name of an unconscious patient). In these cases the sending application is required to indicate the reason that the data is not available 4. Data elements that are marked required if known (R2) must be sent when the sending application has that data available. The sending application must be able to demonstrate that it can send all required if known elements, unless it does not in fact gather that data. When the information is not available, the sending application may indicate the reason that the data is not available. Data elements that are marked optional (O) may be sent at the choice of the sending application. Since a content module may include data elements not specified by the profile, some might ask why these are specified in a content module. The reason for specifying the optional data elements is to ensure that both sender and receiver use the appropriate semantic interpretation of these elements. Thus, an optional element need not be sent, but when it is sent, the content module defines the meaning of that data element, and a receiver can always be assured of what that data element represents when it is present. Senders should not send an optional data element with an unknown value. If the value is not known, simply do not send the data element. Other data elements may be included in an instance of a content module above what is defined by this supplement. Receivers are not required to process these elements, and if they do not understand them, must ignore them. Thus, it is not an error to include more than is asked for, but it is an error to reject a content module because it contains more than is defined by the framework. This allows value to be added to the content modules delivered in this framework, through extensions to it that are not defined or profiled by IHE. It further allows content modules to be defined later by IHE that are refinements or improvements over previous content modules. For example, in the PCC Technical Framework, there is a Referral Summary content module defined in this framework. The ED Referral content module was created and it inherited the constraints of the Referral Summary content module, with a few more use case specific constraints added. Systems that do not understand the ED Referral content module but do understand the Referral Summary content module will be able to interoperate with systems that send instances of documents that conform to the ED Referral content module. This interoperability, albeit at a 4 The reason why the information is missing is indication via the use of the value null flavor (An exceptional value expressing missing information and possibly the reason why the information is missing). Rev Copyright 2010: IHE International