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

Transcription

1 Integrating the Healthcare Enterprise 5 IHE Quality, Research, and Public Health Technical Framework Supplement 10 Mother and Child Health (MCH) 15 Trial Implementation Supplement August 10, Copyright 2009: IHE International

2 IHE Technical Framework Supplement - Mother and Child Health (MCH) This is a supplement to the forthcoming IHE QRPH Technical Framework. It is submitted for trial implementation at IHE Connectathons beginning in January Comments on the profile should be submitted to Select Supplements for Trial Implementation Select Maternal and Child Health (MCH) You will need to login or create an account before making your posting. Post brief comments by starting a new discussion thread in this subforum or replying to an existing one. Please use the Public Comment Template provided there for extensive comments and attach it to a new thread or reply posting. 35 General Information about IHE may be found at: Information about the IHE QRPH domain may be found at: Information about the structure of IHE Technical Frameworks and Supplements may be found at: and The IHE QRPH Technical Framework is not yet published as a consolidated volume. Previous supplements may be found at: Editor s Note This supplement describes the 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 is not bolded or underlined for readability. "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: Copyright 2009: IHE International

3 IHE Technical Framework Supplement - Mother and Child Health (MCH) CONTENTS Editor s Note... 1 Volume 1 Integration and Content Profiles... 7 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 Document Content Modules Constraints Specification Conformance Schematron Section Content Modules Constraints Parent Template Entry and Header Content Modules Constraints Transactions Retrieve Form for Data Capture Transactions IHE MCH Bindings Namespaces and Vocabularies IHE Format Codes IHE ActCode Vocabulary IHE RoleCode Vocabulary Copyright 2009: IHE International

4 IHE Technical Framework Supplement - Mother and Child Health (MCH) 6 Content Specifications Conventions Folder Content Modules QRPH MCH Content Modules Document Content Modules Health Birth Summary Specification Standards Document Code (LOINC) Specification Child Growth Summary Specification Standards Document Code (LOINC) Specification CDA Header Content Modules CDA Section Content Modules QRPH MCH HBS History of Tobacco Use Section QRPH MCH HBS Coded Social History Section QRPH MCH Labor and Delivery Section Psychomotor Development Section QRPH MCH CGS Coded Physical Examination Section QRPH MCH CGS Coded Functional Status Assessment CDA or HL7 Version 3 Entry Content Modules HBS Tobacco Use History Observation Psychomotor Test Observation MCH Labor and Delivery Observations Neurological System Observation Heart Observation Respiratory System Observation Abdomen Observation Endocrine System Observation Genitalia Observation Musculoskeletal System Observation Lymphatic System Observation Integumentary System Observation Eye Observation Ears Observation Mouth, Throat, and Teeth Observation QRPH MCH CGS Functional Status Observations 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 Copyright 2009: IHE International

5 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 Copyright 2009: IHE International

6 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 such as the birth certificate contain important information about the antepartum period, the labor and delivery process and the newborn 1. The birth certificate can be pre-populated with information that is already exiting in the EHRs with the responsible HCP filling out the rest of the information. The birth certificate can then be sent to health authorities such as Social Services for possible intervention, or to Public Health agencies for epidemiological studies concerning population s general health. Profile Abstract This profile describes the contents to be used in automating the data capture in vital records such as the birth certificate 2. The certificate(s) are pre-populated with data from the EHR, filled with the necessary information and further submitted to the interested organizations 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 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. 3. Not all the information might be present, depending on the existence of an antepartum record (APR) and a labor and delivery record (LDR). 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 Copyright 2009: IHE International

7 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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. 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 Copyright 2009: IHE International

8 IHE Technical Framework Supplement - Mother and Child Health (MCH) Volume 1 Integration and Content Profiles Glossary Apgar scores 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 < 7 then additional Apgar scores should be taken every 5 min up to 20 min 3. The score is based on the following criteria: Appearance: Color 0 for blue, 1 for body pink, extremities blue, 2 for pink. Pulse: Heart rate 0 for none, 1 for <100/min, 2 for > 100/min. Grimace: Reflex 0 for none, 1 for grimace, 2 for cough/sneeze. Activity: Muscle tone 0 for limp, 1 for some flexion, 2 for full flexion. Respiratory: Effort 0 for absent, 1 for weak or irregular, 2 for strong crying. APS Antepartum Summary content profile the Supplement for Trial Implementation APR Antepartum Record content profile ATNA Audit Trail and Node Authentication. IT Infrastructure profile, described in ITI TF-1:9, and published in the ITI Technical Framework, version 6.0. Antibiotics An antibiotic is a chemotherapeutic agent that inhibits or abolishes the growth of micro-organisms, such as bacteria, fungi, or protozoans. 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. 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. Breech presentation 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 3 AAP Guidelines for Perinatal Care. 6th Edition. P Copyright 2009: IHE International

9 IHE Technical Framework Supplement - Mother and Child Health (MCH) (frank breech presentation); or one or both feet or knees may be prolapsed into the maternal vagina (incomplete breech presentation). C-section A C-section or Caesarean section is a surgical procedure consisting in a laparotomy (abdomen incision), and hysterotomy (uterus incision) to deliver one or more babies. Cephalic presentation Presentation of any part of the fetal head in labor, whether the vertex, face, or brow. 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. Chromosome abnormalities Any change 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. Congenital heart defects A 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. Congenital hip dislocation Congenital hip dysplasia Pediatric orthopedics 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. 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. CT Consistent Time. IT Infrastructure profile, described in ITI TF-1:7, and published in the ITI Technical Framework, version Copyright 2009: IHE International

10 IHE Technical Framework Supplement - Mother and Child Health (MCH) DSG Document Digital Signature. IT Infrastructure profile, described in ITI TF-3:4, and published the ITI Supplement for Trial Implementation. Down syndrome Down syndrome or trisomy 21 is a genetic disorder caused by the presence of all or part of an extra 21st chromosome. Eczema 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 The 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 Anesthesia produced by injecting local anesthetic agent into the epidural space of the spinal canal at the first or second intercoccygeal space. 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. Gastroesophageal reflux Reflux of the stomach and duodenal contents into the esophagus. Gastroschisis Gastroschisis is a type of abdominal wall defect in which the intestines and sometimes other organs develop outside the fetal abdomen through an opening in the abdominal wall. This defect is the result of obstruction of the omphalomesenteric vessels during development. 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 Copyright 2009: IHE International

11 IHE Technical Framework Supplement - Mother and Child Health (MCH) The genitourinary system 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) 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 A 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: 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. Immunoglobulin A concentrated 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. Induced onset of labour When labour is brought on by extraneous means, e.g. by the use of drugs that cause uterine contractions; called also artificial labor Copyright 2009: IHE International

12 IHE Technical Framework Supplement - Mother and Child Health (MCH) In-utero transfer Transfer of the pregnant mother to another birthing facility. 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). 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. Labiopalatine cleft Cleft lip and cleft palate, which can also occur together as cleft lip and palate are variations of a type of clefting congenital deformity caused by abnormal facial development during gestation. LDHP Labor and Delivery Admission History and Physical content profile. 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. MDS Maternal Discharge Summary content profile, part of the Labor and Delivery Record profile. PCC Supplement for Trial Implementation. Neural tube defects A neural tube defect will occur in human embryos if there is an interference with the closure of the neural tube. Nuchal translucency scan A nuchal translucency scan is a 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 An omphalocele is a type of abdominal wall defect in which the intestines, liver, and occasionally other organs remain outside of the abdomen in a sac because of a defect in the development of the muscles of the abdominal wall Copyright 2009: IHE International

13 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 A disorder occurring during late pregnancy or immediately following parturition, characterized by hypertension, edema, and proteinuria. Also called toxemia of pregnancy. Premature (less than 33 weeks) Delivery between 20 and 36 6/7 weeks gestation Premature labor Premature labor is the term to describe contractions of the uterus that begin at weeks of a pregnancy. Presentation The presentation is the part of the fetus lying over the pelvic inlet; the presenting body part of the fetus Polymalformative syndrome A 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. 475 Spina bifida Spina bifida is a developmental birth defect involving the neural tube: incomplete closure of the embryonic neural tube results in an incompletely formed spinal cord. 480 Spinal aneshesia Spinal anesthesia or sub-arachnoidal block is a form of regional anesthesia involving the injection of local anaesthetic into the cerebrospinal fluid. Stillborn Copyright 2009: IHE International

14 IHE Technical Framework Supplement - Mother and Child Health (MCH) An infant delivered without signs of life after reaching mid-second trimester to full term gestational age. In the US this is usually after 20 or greater weeks gestation. In the UK this has been reported as an infant delivered without signs of life until after 24 weeks gestation. Metabolism disorder 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 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 In the second stage of labour, the baby is pushed through the womb through the vagina by both the uterine contractions and by the additional maternal efforts. Vaginal birth with forceps Forceps can be used to assist the delivery of a baby as an alternative to the ventouse method. 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. XDR Cross Enterprise Document Reliable Interchange. IT Infrastructure profile, described in ITI TF- 1:15, and published as a supplement for Trial Implementation. 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 Copyright 2009: IHE International

15 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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. The Mother and Child (MCH) content profile contains two content profiles, namely the: Health at Birth Summary (HBS) Child Growth Summary (CGS) 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. 530 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 Copyright 2009: IHE International

16 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 pediatrician and the general physician fill out certificates (such as birth certificates or health certificates), and in some cases throughout the very early childhood period 4. 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 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. Figure Mother Child Health Actor Diagram 4 The birth certificate and the health certificates contain the same type of information. The difference is due to national extensions practices Copyright 2009: IHE International

17 560 IHE Technical Framework Supplement - Mother and Child Health (MCH) 1.2. 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. 565 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 1.3. Grouping 570 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. 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 Copyright 2009: IHE International

18 IHE Technical Framework Supplement - Mother and Child Health (MCH) Use-Case 1: Birth Certificate The mother fills out the Mother s Worksheet with the pertinent elements concerning (e.g., race, Hispanic origin, education, cigarette smoking, and participation in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). The birthing facility will fill in medical elements which are obtained directly from medical records of the mother and infant. A pre-populated form is filled out with medical elements from the EHR. Additional data from the Mother s Worksheet is captured by the clerk or the HCP, and the form is sent to the authority in charge (Social Service and/or Public Health). The format in which data is submitted to the authority is out of scope of this profile and may be developed in future work. 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 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 Copyright 2009: IHE International

19 IHE Technical Framework Supplement - Mother and Child Health (MCH) Data source (Obstetrician/Midwife) Data source (Child s clinician) Data consumer/ Form Manager Social Services Public Health PMI Birth Certificate Capture data Retrieve Birth Certificate Form Send completed form Health Certificate Data Collection Complete form Retrieve prepopulated Health Report Form Send completed form 625 Figure X.2-1. Basic Process Flow in Mother and Child Health Profile 1.5. 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 profiles (e.g. XDS, XDR), then the Security Considerations for the integration profiles will be used when implementing the MCH profile Copyright 2009: IHE International

20 640 IHE Technical Framework Supplement - Mother and Child Health (MCH) MCH Specific Risk Considerations 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 new born child. This introduces a risk for data integrity of the mother s and child s record. The mitigation for this risk is archived by a properly conifgured system which handles the documentation of the delivery process and unambiguously allows the recording of the appropriate data for the mother and child Copyright 2009: IHE International

21 IHE Technical Framework Supplement - Mother and Child Health (MCH) 645 Volume 2 Transactions and Content Specifications 1. Preface to Volume Intended Audience 650 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 1.2. 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) Copyright 2009: IHE International

22 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 690 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 695 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 Figure Use Case Role Diagram Referenced Standards: the standards (stating the specific parts, chapters or sections thereof) to be used for the transaction. 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: Copyright 2009: IHE International

23 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 720 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 725 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 ihe@himss.org Copyright 2009: IHE International

24 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 Copyright 2009: IHE International

25 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 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 795 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 Copyright 2009: IHE International

26 IHE Technical Framework Supplement - Mother and Child Health (MCH) 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 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 5. 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 5 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) Copyright 2009: IHE International