Ministry of Health Standards and Guidelines for Primary Health Care Electronic Medical Record Systems in Kenya

Transcription

1 Ministry of Health Standards and Guidelines for Primary Health Care Electronic Medical Record Systems in Kenya PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 1 -

2 Acknowledgements The Standards and Guidelines for Primary Health Care Electronic Medical Record Systems in Kenya is derived from the Standards and Guidelines for EMR Systems in Kenya launched in The document has been developed from international standards, WHO guidelines, and best practices of EMR installations in Kenya and other similar setups. Coordination of the development of this document has been provided by the Ministry of Health in Kenya. Key Contributors Division of HIS Dr. Charles Nzioka Dr. Ayub Manya Jeremiah Mumo Nancy Amayo Pepela Wanjala Samuel Cheburet Division of Vector Borne and Neglected Tropical Diseases Benedette Ajwang Division of Vaccines and Immunization Peter Ademba Steve Mwangi Division of Reproductive Health Rose Ayugi Francis Kangwana Division of Disease Surveillance and Response David Kareko Division of Malaria Control Jacinta Opondo Department of Community Health Services Kenneth Ogendo Division of Non-Communicable Diseases Dr. Gladwell Gathecha National AIDS & STI Control Programme Julius Mutiso Center for Disease Prevention and Control James Kwach CDC Kenya Tom Oluoch CDC Kenya International Training & Education Center for Health Dr. Patrick Odawo Dr. Bill Lober George Owiso Jan flowers Samuel Kang a Steven Wanyee Veronica Muthee Afya Bora Consortium Dr. Jason Madrano Afya Info Solomon Simba Division of Nutrition Nancy Deya Division of Child and Adolescent Health Bernard Wambu Jedidah Obure Division of Leprosy, Tuberculosis and Lung Disease James Sekento Aga Khan University Hospital - Nairobi Soderlund Ochungo Division of HIS Support Staff Dorcas Nguyo George Mbugua PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 2 -

3 Acronyms ANC Ante Natal Care APGAR - American Paediatric Gross Assessment Record ART - Antiretroviral Therapy ARV - Antiretroviral C/S - Caesarean Section CD4 - Cluster of Differentiation 4 CDA - Clinical Document Architecture CDC Center for Disease Control and Prevention CPOE - Computerized Physician Order Entry CWC - Child Welfare Clinic DHIS - District Health Information System EDD - Estimated Delivery Date EHR Electronic Health Record EMR Electronic Medical Record HIS Health Information System HIV - Human Immunodeficiency Virus PCR - Polymerase Chain Reaction HL7 - Health Level Seven International ICD 10 International Classification of Diseases version 10 IHE - Integrating the Healthcare Enterprise IPT - Intermittent Preventive Treatment for malaria ISO - International Organization for Standardization ITN - Insecticide Treated Net KEPI - Kenya Expanded Programme on Immunization LLITN Long Lasting Insecticidal Treatment Net LMP - Last Menstrual Period LTF Lost to Follow-up MIP - Malaria in Pregnancy MFL Master Facility List PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 3 -

4 MoH Ministry of Health MUAC - Mid Upper Arm Circumference NASCOP - National AIDS and STD Control Programme PHC Primary Health Care PMTCT - Prevention of Mother-To-Child Transmission PPH - Postpartum Haemorrhage RPR - Rapid Plasma Reagin SNOMED - Systematized Nomenclature of Medicine SVD - Spontaneous Vaginal Delivery TB Tuberculosis TCP/IP - Transmission Control Protocol and Internet Protocol TWG Technical Working Group WHO World Health Information PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 4 -

5 Table of Contents ACRONYMS EXECUTIVE SUMMARY OVERVIEW INTRODUCTION BACKGROUND RATIONALE PURPOSE AND AUDIENCE EVOLUTION FUNCTIONAL REQUIREMENTS BASIC DEMOGRAPHIC AND CLINICAL HEALTH INFORMATION Individual demographic data Patient's problem list Medication list Vital signs and physiologic measures Reason for current visit Risk factors Allergies, intolerances, and adverse reactions Procedures and test results Referrals and hospitalisations Lifestyle interventions and recommendations CLINICAL DECISION SUPPORT Access to clinical fields and algorithms Alerts Allergy, intolerance, and adverse reaction alerts Medication alerts Reminders Automated real-time surveillance ORDER ENTRY AND PRESCRIBING Medication orders Laboratory and diagnostic test orders HEALTH INFORMATION AND REPORTING INFORMATION SECURITY PATIENT EDUCATION ADMINISTRATIVE PROCESSES SUPPORT Patient scheduling management Patient eligibility EXCHANGE OF ELECTRONIC INFORMATION EXCHANGE OF ELECTRONIC HEALTH INFORMATION SHARING MEDICAL SUMMARIES DISTRIBUTED PATIENT MANAGEMENT CENTRALIZED PATIENT MANAGEMENT MINIMUM DATA SETS PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 5 -

6 4.1 TRANSFER SUMMARIES ANTENATAL CARE REGISTER (MOH 405) IMMUNIZATION REGISTER (MOH 510) POSTNATAL REGISTER (MOH 406) MATERNITY REGISTER (MOH 333) INPATIENT REGISTRY (MOH 301) CHILD WELFARE CLINIC REGISTER (MOH 511) OUTPATIENT REGISTER FOR OVER 5 YEAR OLDS (MOH 204B) OUTPATIENT REGISTER FOR UNDER 5 YEARS OLDS (MOH 204A) COMMUNITY HEALTH WORK REGISTER (MOH 513) NEGLECTED TROPICAL DISEASES REGISTER HIV/AIDS CARE CONTENT TUBERCULOSIS CARE REGISTER INTEGRATED CASE BASED SURVEILLANCE FORM (MOH 502) IDSR HEALTH FACILITY LINE LISTING FORM (MOH 503) OPERATIONAL REQUIREMENTS SYSTEM DEVELOPMENT SYSTEM IMPLEMENTATION SYSTEM MAINTENANCE RELIABLE SOURCE OF POWER PHYSICAL SECURITY COMPUTER VIRUS PREVENTION CAPACITY DEVELOPMENT MEANINGFUL USE GOVERNANCE & POLICY MONITORING AND EVALUATION APPENDICES APPENDIX 1: PHC EMR IMPLEMENTATION PHASES APPENDIX 2: RECOMMENDED COMPETENCIES FOR PHC EMR APPENDIX 3: MEANINGFUL USE OBJECTIVES AND MEASURES APPENDIX 4: APGAR SCORING FOR NEW-BORNS: APPENDIX 5: CLINICAL DECISION SUPPORT FUNCTIONS EXAMPLES APPENDIX 6: SITE READINESS ASSESSMENT TOOL APPENDIX 7: STANDARD OPERATING PROCEDURES (SOP) FOR ASSESSING FACILITY/SITE READINESS FOR EMR IMPLEMENTATION PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 6 -

7 Executive Summary To continue improving health care in Kenya, electronic medical record systems must expand to include primary health care. And to ensure the best interests of the health care system, it is essential that standards and guidelines regulate that expansion. This document builds upon the original Standards and Guidelines for Electronic Medical Record Systems in Kenya and specifies the standards and guidelines for primary health care information systems in Kenya. Kenya's Ministry of Health, implementation partners, and international organizations increasingly call for reliable information to guide the health care system. The on-going rollout of standardized electronic medical record systems at public HIV facilities is already providing reliable information to decision makers. Expanding standardization to include primary health care information systems is an essential next step in Kenya. Standardized electronic information systems improve data collection, reduce errors, and automate reporting, allowing facilities to focus on service. Standardized electronic information systems communicate with each other, promoting a unified health information system in Kenya. People move within Kenya; with standardized systems, patient health information follows them wherever they go. This document builds upon the original Standards and Guidelines for Electronic Medical Record Systems in Kenya by expanding functional requirements to support primary health care. Electronic primary health care information systems must support the facilities in which they are installed. To support facility operations, electronic primary health care information systems must fulfil the following functional areas, which we describe in detail later in this document: 1. Basic demographic and clinical health information 2. Clinical decision support 3. Order entry and prescribing 4. Health information and reporting PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 7 -

8 5. Information security 6. Exchange of electronic information 7. Patient education 8. Administrative process support Exchange of electronic data is a crucial and complex component of electronic information systems, so we dedicate a separate section of this document to it. Just as the electronic system must support the operations of the facility, the facility must support the electronic system. To support electronic primary health care information systems, facilities must fulfil the following operational areas, which we describe in detail later in this document: 1. System development 2. System implementation 3. System maintenance 4. Reliable source of power 5. Physical security 6. Computer virus prevention Kenya is leading the way towards integrated and standardized health information systems. Standardizing primary health care information systems is a crucial next step in that process. Standardized primary health care information systems will improve information quality and timeliness, reduce errors, and facilitate communication across the health information system. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 8 -

9 1. Overview 1.1 Introduction The World Health Organization defined primary health care (PHC) in the seminal Report of the International Conference on Primary Health Care: Primary health care is essential health care based on practical, scientifically sound and socially acceptable methods and technology made universally accessible to individuals and families in the community through their full participation and at a cost that the community and country can afford to maintain at every stage of their development in the spirit of self reliance and self determination. 1 Primary health care is a conceptual model which refers to both processes and beliefs about the ways in which health care is structured. It encompasses primary care, disease prevention, health promotion, population health, and community development within a holistic framework, with the aim of providing essential community-focused health care 2. The services provided under PHC are: maternal and child care, including family planning; immunization against infectious diseases; prevention and control of locally endemic diseases; education concerning prevailing health problems and the methods of preventing and controlling them; and appropriate treatment for common diseases and injuries. This document describes the electronic information systems requirements for PHC. 1 World Health Organization. (1978, September). Alma-Ata 1978: primary health care. In Report of the International Conference on Primary Health Care (pp. 3). Alma-Ata, USSR. Geneva: World Health Organization.. 2 R. Thomas-MacLean, S. Ackroyd-Stolarz, M. Fortin, M. Stewart, Conceptualizing Primary Health Care. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page - 9 -

10 1.2 Background Health facilities across Kenya have increasingly adopted electronic medical record (EMR) systems to improve health records and program management, and enhance patient care. However, the adoption of EMR systems was not effectively coordinated, resulting in systems with varied functionality and inadequate data sharing. Kenya s Ministry of Health (MoH), with support from development partners, generated the Standards and Guidelines for Electronic Medical Record Systems in Kenya to address the varied implementation and use of EMR systems at health facilities across Kenya. The Standards and Guidelines document targeted EMR system developers and EMR system adopters to ensure that systems did not exist in isolation but could communicate with each other and share information to improve health care. The original Standards and Guidelines document emphasizes HIV care and treatment because, at the time of its writing, the majority of Kenya s existing EMRs concentrated on HIV care and treatment. These guidelines are based on national and international reference documents, including: WHO and Kenya health care guidelines The Kenya HIS strategic plan Kenyan and international health informatics standards, including the International Organizations for Standards (ISO) Experience from MoH and partners in Kenya and from other countries Published medical, primary health, and public health literature 1.3 Rationale Over time, EMR systems have been enhanced to collect information for primary health care (PHC) in addition to HIV care and treatment. Enhanced EMR functionality beyond HIV care and treatment created a gap between the original Standards and Guidelines and the expanded scope of existing EMR systems. To address the gap between standards and EMRs, the MoH has undertaken expanding the Standards and Guidelines to cover PHC, which is detailed in this document. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

11 1.4 Purpose and Audience This document targets PHC EMR system developers and implementers, and defines functional requirements that systems should meet and minimum data sets that systems should collect. Furthermore, this document endorses the need for systems to communicate and share data with other health systems and the need to develop relevant competence to ensure sustainability of the developed systems. The overarching goal is improved health care for the people of Kenya. 1.5 Evolution This Standards and Guidelines for Primary Health Care Electronic Medical Record Systems in Kenya document should be seen as dynamic and evolving. Because technology and user needs change over time, the PHC standards will need occasional revision. The Health Informatics Technical Working Group is responsible for this document and should determine the process and frequency of the document s revision. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

12 2. Functional Requirements Functional requirements refer to the capabilities that a system must be able to perform successfully. The following PHC EMR functional requirements are derived from existing literature, PHC providers, and the requirements defined by the Standards and Guidelines for Electronic Medical Record systems in Kenya 3,4,5. They are intended to facilitate PHC delivery through EMRs. The original Standards and Guidelines document identified six functional requirements for EMRs: i. Basic Demographic and Clinical Health Information ii. Clinical Decision Support iii. Order Entry and Prescribing iv. Health Information and Reporting v. Security and Confidentiality vi. Exchange of Electronic Information This document builds on the six functional requirements and extends two functional requirements: vii. Patient Education viii. Administrative Process Support This section describes functional requirements for PHC EMRs. Some of these functional requirements necessitate data which is specified in section 4 of this document. 3 Kenya Ministry of Health, Standards and Guidelines for Electronic Medical Record Systems in Kenya. 4 E. Tomasi, L. A. Facchini, M. F.S. Maia, Health information technology in primary health care in developing countries: a literature review. 5 Certification Commission for Healthcare Information Technology, CCHIT Certification - What does it require? Accessed on 21 st February, PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

13 2.1 Basic demographic and clinical health information Basic demographic and clinical health information is essential to primary health care. This section is divided into subsections based on the type of information that the PHC EMR systems should collect Individual demographic data The system should: i. Generate a unique patient identifier that cannot be edited by a user. ii. Enable a user to electronically record, modify, and retrieve patient demographic data including full names, government-issued identification numbers, gender, date of birth, residence, next of kin details, telephone contact, and date and cause of death in the event of mortality. iii. Define data fields in discreet and structured format, i.e. not entered as unstructured notes or free text. iv. Have broad search parameters to avoid duplication, e.g. identification numbers, name, telephone number, clinic number. v. Be able to detect and flag duplicate patient records Patient's problem list The system should: i. Capture, display, and report all active diagnoses associated with the patient. ii. Base its problem list fields on standardized nomenclature such as ICD 10 or SNOMED iii. Define data fields in discreet and structured format iv. Capture the source, date, and time of all changes to the problem list. v. Allow deactivating a problem and keep a trail of all deactivated problems. vi. Incorporate phrase look-ups or pick lists to populate the problem lists. vii. Facilitate manually ordering/sorting the problem list. viii. Capture the chronicity (chronic, acute/self-limiting, etc.) of a problem. ix. Allow re-activating previously deactivated problems. x. Associate encounters, orders, medications, notes with one or more problems. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

14 2.1.3 Medication list The system should: i. Electronically record, modify and retrieve a list of the patient s active medications, and historical medications ii. Capture, display, and report all medication changes. iii. Reconcile a patient s medication lists into a single medication list. iv. Maintain medication lists using generic and proprietary names, and standard formulations. v. Define data fields in discreet and structured format Vital signs and physiologic measures The system should: i. Capture, display, and report vital signs and physiological measures such as temperature, height, weight, blood pressure, respiratory rate, and heart rate. ii. Define data fields in discreet and structured format iii. Calculate body mass index. iv. Display paediatric growth charts when applicable. v. Record and chart changes in physiological measures Reason for current visit The system should capture, display, and report the reason for the current visit, i.e. the presenting complaint of the patient Risk factors The system should: i. Capture, modify and display risk factors, which are defined as any attribute, characteristic or exposure of an individual that increases the likelihood of developing a disease or injury. ii. Capture and display family medical history, e.g. diagnosed cases of diabetes. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

15 2.1.7 Allergies, intolerances, and adverse reactions The system should: i. Record, modify and retrieve a patient s active and historical allergies, non-allergy intolerances, and adverse reactions, including those caused by medication, food, and environmental products. ii. Define data fields in discreet and structured format Procedures and test results The system should: i. Capture and display all procedures and their corresponding results. ii. iii. iv. Capture and display all laboratory tests and their corresponding results. Capture and display all diagnostic tests and their corresponding results. Define data fields in discreet and structured format Referrals and hospitalisations The system should: i. Capture and display patient referrals and hospitalizations. ii. iii. Generate a clinical summary or continuity of care document transmittable in machine-readable electronic format and exportable in human-readable format. Communicate electronically with the Kenya Master Facility List (MFL) and the Community Facility List to facilitate referrals between facilities Lifestyle interventions and recommendations The system should capture and display patient lifestyle interventions and recommendations. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

16 2.2 Clinical Decision Support Clinical decision support is a system to enhance clinical decision-making for providers, by relating patient information with clinical knowledge. The use of EMR-based clinical decision support has been shown to improve quality of health care through: better diagnosis, reduced medication errors, improved practitioner performance and improved compliance with guidelines 6. Specific examples of clinical decision support within primary health care are given in appendix 5. PHC EMR should provide: Access to clinical fields and algorithms The system should: i. Capture, modify and display clinical data fields to facilitate clinical decision support. ii. iii. Display algorithms that aid in clinical decision support. Define data fields in discreet and structured format Alerts The system should: i. Automatically track, record, and generate reports on the number and type of alerts ii. presented, and the number and type of alerts responded to by each user. Allow administrators to customize alerts and alert criteria, to best suit local needs and circumstances. The following two subsections describe specific types of alerts Allergy, intolerance, and adverse reaction alerts i. The system should automatically generate, alerts for medication allergies, nonallergy intolerance, and adverse reactions. 6 T. Oluoch, X. Santas, D. Kwaro, M. Were, P. Biondich, C. Bailey, A. Abu-Hanna, N. de Keizer The effect of electronic medical record-based clinical decision support on HIV care in resource-constrained settings: A systematic review. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

17 Medication alerts The system should: i. Display alerts related to inappropriate medication dosages, medication ii. iii. interactions, and medication contraindications on a patient-specific basis. Display alerts when recalled drugs are prescribed. Support pharmacovigilance reporting, including adverse drug reactions, adverse events, and medication errors Reminders The system should issue reminders to users for preventive care and health management services, e.g. vaccinations, screenings, and clinical treatment guidelines for specific diagnoses Automated real-time surveillance The system should: i. Capture and report adverse events and near misses. ii. Maintain facility-specific surveillance thresholds and send alerts when thresholds are met. 2.3 Order entry and prescribing Computerized provider order entry (CPOE) is the process of entering medication orders, treatment orders, and diagnostic test orders electronically. Because CPOE involves electronic order entry, and not paper, its use can help reduce errors related to poor handwriting and order transcription, can expedite order completion, and can improve clinical decision-making. PHC EMRs should support two broad types of CPOE, medication orders and test orders. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

18 2.3.1 Medication orders The system should: i. Capture, record, and display electronic medication orders including: name of the drug, dosage, route of administration, frequency, duration, form of drug, instruction for use ii. Display hierarchy of medication regimens, from first-line to advanced regimens. iii. Display medication lists using generic and proprietary names, and standard formulations. iv. Display a preferred drug list. v. Reference a drug formulary Laboratory and diagnostic test orders The system should: i. Capture, modify and display laboratory and diagnostic test orders, including: test types and specimen type when necessary. ii. iii. Characterize tests according to standardized classification. Display and export orders in human-readable format. 2.4 Health Information and Reporting EMRs are intended to improve the use of health information by providers and patients and expedite the process of reporting for internal and external use. To support these functions, PHC EMRs should: i. Create an electronic copy of the discharge instructions and procedures for a patient, in human readable format, at the time of discharge to provide to a patient on electronic media, or on paper. ii. Provide clinical dashboards to display graphical trends of patient data related to health, care, and treatment. iii. Generate patient lists by specific conditions, to be used for quality improvement, reduction of disparities, research, and outreach. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

19 iv. Generate and submit aggregated health facility reports to the national level District Health Information System (DHIS). v. Generate standard administrative reports such as service utilization, length-of-stay, and staff allocation. vi. Create and modify user-defined reports. 2.5 Information Security The security and confidentiality of health information is essential for all EMR systems, to ensure patient privacy. To support security and confidentiality of patient health information, PHC EMRs should: i. Assign unique identity to users. ii. iii. iv. Permit authorized users to access electronic health information including in emergency situations. Terminate an electronic session after a facility-determined time of inactivity. Encrypt and decrypt electronic health data. v. Maintain an audit log. vi. vii. viii. ix. Provide alerts for breaches in security or confidentiality. Enforce health information integrity. Maintain access rights definitions for every system user. Support data backup 2.6 Patient Education i. The system should support patient education by: a. Allowing system users to access education materials b. Allowing customized patient education materials per patient needs c. Tracking education materials provided to patients d. Providing education materials for informal care-givers. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

20 2.7 Administrative Processes Support Patient scheduling management Patient scheduling management is an essential function of primary health care facilities. Scheduling data should be accessible via the PHC EMR system, to support scheduling management for: Patient appointments Patient admissions Patient surgery/procedure schedule Patient eligibility Determining patient eligibility is a useful function of a primary health care facility, and should be facilitated by PHC EMR systems. The systems should provide notification of eligibility for: Insurance Clinical trial recruitment Drug recall Chronic disease management 2.8 Exchange of electronic information EMR systems coexist with other systems in the health care setting. These systems include other EMR systems, laboratory systems, pharmacy systems, and others. In order to promote interoperability between diverse systems, PHC EMRs should: i. Receive patient information as a clinical document using a recognized standard. ii. Generate patient summary information as a clinical document using a recognized standard. iii. Generate aggregate clinical care information using a recognized standard Because it is a complex topic, exchange of electronic information is covered in more detail in section 3 of this document. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

21 Implementation Guidance The following table outlines the functional requirements for the PHC EMR systems in greater detail to provide guidance on how to meet the key functional areas described above. This table is intended for use by PHC EMR system developers to ensure that systems meet minimum specifications for quality care provision and reporting. Health managers may also use this table to evaluate PHC EMR systems for compliance with these requirements. Overall, the functional requirements are categorised as either highly prioritised or lowly prioritised. Highly (H) tagged requirements are for immediate implementation while lowly (L) tagged requirements are for implementation as health information systems evolve in Kenya. Specifications Priority 1 General 1.1 The system supports a function where the contents of the paper record as defined by standardized MOH forms can be entered for inclusion in the EMR. 1.2 The system supports a total paperless function using a point of care system. H L (Where a facility uses a point of care system, the system should allow for the input of care details collected during system downtime. As such, the system will be hybrid to support both point of care and retrospective data entry) 1.3 The system captures data that can be used for individual patient care as well as for program monitoring and evaluation. 1.5 The system should associate key identifier information (e.g., system ID, medical record number) with each patient record. H H (Key identifier information must be unique to the patient record but may take any system or nationally defined form) 1.4 The system allows for summarized information in different parts of the system to be sorted and filtered by date or date ranges and chronology. H 2 Demographics / Patient Identification 2.1 The system supports the generation and use of a unique identifier and allows for the storage and use of more than one identifier for each patient s record. H (For interoperability, systems need to be able to store additional patient identifiers. Examples PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

22 include an ID generated by a Master Patient Index, a health plan ID, regional and/or national patient identifiers if/when available) 2.2 The system captures and maintains demographic information. At minimum, the system should capture the following demographic information: H (The demographic information is in line with ISO/TS 22220: Health Informatics Identification of Subjects of health care. Multiple patient identifier information should be collected to enhance the accuracy of identification) Patient Names Surname, First Name and Other Name H (Surname is Mandatory. A minimum of 3 names is required for good identification) Sex H Date of Birth H Place of Birth H Patient s physical address H Patient s telephone contact H Next of Kin: Name, Address and Contacts H Biometric identifiers L 2.4 The system displays multiple patient identifying information at each interaction with the patient record to facilitate accurate patient identification. 2.5 The system should provide the ability to maintain and make available historic information for demographic data including prior names, addresses and phone numbers. H H (Providers need this for look up and contact purposes, e.g., when attempting to locate a patient or family member for clinical communications) 2.5 The system has the capability of importing existing patient demographic data via a standardized HL7 interface format from an existing EMR system. H 3 Patient History 3.1 The system allows the capture or entry of past patient history as relates to medical, surgical, obs/gyn and other care. H 3.2 For each new patient, the system captures and stores risk factors. For example: TB Status H Tobacco use and history H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

23 3.2.3 Alcohol use, history H Drug use, history H History of chronic illnesses such as hypertension, diabetes H 3.3 For each new patient, the system captures and stores, at minimum, the following social history elements: Marital Status H Occupation (Standard list with selectable options should be provided) H Socioeconomic status (Standard list with selectable options should be provided) H Education (Standard list with selectable options should be provided) H 3.4 The system has the capability to import patient health history data from an existing system using a standardized MOH HL7 format. H 3.5 The system documents hospitalization and OPD data including: Admission and Discharge dates for all type of hospitalizations H Chief complaint H Admitting diagnosis / OPD diagnoses H Procedures performed H Discharge summary H OPD visit date(s) H 3.6 The system documents all existing allergies, intolerance and adverse reactions to drugs and interactions, including dietary and environmental triggers. At minimum, it records: the allergen (drug), type of reaction and date The system captures the reaction type and severity of the reaction H (Systems should display a selectable list of common ADRs and allow text input of unlisted ones) 3.7 The system captures history of received immunizations and is able to display a report on the patient s immunization status. H 3.8 The system collects and stores family history, including, but not limited to: History of chronic diseases such as hypertension, diabetes and cancers, including date of diagnosis H If deceased: date and cause of death H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

24 4 Current Health Encounters 4.1 The system should support the capture / entry of any type of clinical event, encounter or episode relevant to the care of a patient. 4.2 The system includes forms for data capture as well as patient and treatment forms as defined by the Ministry of Health s data requirements. 4.3 The system has the capability to receive clinical documentation and notes via a standard HL7 interface. H H H 4.4 The system has the capability to capture vital signs data. At minimum, the system collects: Height H Weight H Pulse rate H Respiratory rate H Blood pressure (including multiples) H BMI (calculated) H Mid Upper Arm Circumference (MUAC) for children H 4.5 The system has the capability to capture and edit health data regarding the patient s current health status, including (as applicable): Chief complaint H Onset of symptoms including duration of symptoms H Physical examination findings H Diagnosis H Performed/planned Laboratory procedures H Medications prescribed H Non-drug prescriptions (e.g. exercise, dietary recommendations, vitamin supplements, and alternative therapies including physiotherapy) H Patient education H Follow-up plans including dates for next visit H 4.6 The system enables the documentation and tracking of referrals between care providers or healthcare organizations. The following information is captured for every referral: H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

25 4.6.1 Reason for referral H (A predefined list to be maintained for easy selection.) Date H Referring Provider H Referred to Provider H The system applies security controls to clinical notes to ensure that data cannot be deleted or altered except within the current session and by an authorized user The system supports the capability to collect the minimum data elements defined by the associated clinical practice guidelines e.g. minimum data elements for HIV care, TB care. H H 5 Problem Lists 5.1 The system creates, maintains and reports all active problems associated with the patient. H 5.2 The system provides a problem status (active, inactive) for each shown problem. H 5.3 When capturing problem information, the system captures at minimum: Diagnosis / problem date(s) H Severity of illness H 5.4 The system should provide the ability to maintain a coded list of problems/diagnoses. H 6 Clinical Practice Guidelines (CPG) 6.1 The system includes and maintains evidence-based Clinical Guidelines (for diseases such as HIV, TB, Malaria) published and maintained by credible sources such as the MOH, NASCOP, Malaria and TB program. The guidelines incorporate alerts and reminders. H 6.2 The system includes decision support prompts to support clinical guidelines and protocols H 6.3 The system has the capability of allowing revising of clinical practice guidelines. H 6.4 The system allows the provider or other authorized user to override any or all parts of the guideline. The system is able to collect exceptions for NOT following the guidelines including reasons for overriding and details of provider. H 7 Prevention 7.1 The system has the capability to display health prevention prompts on the summary display. The prompts must be dynamic and take into account sex, age, and chronic conditions. L 7.3 The system includes a patient tracking and reminder capability (patient follow-up). H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

26 7.4 The system includes the incorporation of immunization protocols: For children as per KEPI schedule H Captures and shows the date due for an immunization H 8 Patient Education 8.1 The system has the capability to create, review, update, or delete patient education plans and materials as defined by disease programs. 8.2 The system has the capability to create, review, update, or delete patient education materials. L L 9 Results 9.1 The system has the capability to manage, and present current and historical test results to appropriate clinical personnel for review, with the ability to filter and compare results with previous tests. H 9.2 The system is capable of receiving test results from laboratory or radiology / imaging results H 9.3 Laboratory and radiology results are received via a standard HL7 interface. H 9.4 When displaying results, the system, at a minimum, displays the patient name, date and time of order, date and time results were last updated. H 9.5 The system uses visual cues to highlight abnormal results. H 9.6 The system allows the provider to comment on received lab results or the data entry personnel to capture comments on results. H 10 Medication and Immunization Management 10.1 The system creates prescriptions or other medication orders with detail adequate for correct filling and administration, and captures the identity of the prescriber. H At minimum, the system should capture: the name of the drug, the dose, the frequency of administration 10.2 The system has the capability of creating and maintaining a current medication list for each patient The system presents to clinicians/users the list of medications that are to be administered to a patient and captures administration details including dose of medications and route of administration. The clinician is able to select prescribed drugs from pull down menus. H H 10.4 The system identifies drug interaction warnings at the point of medication ordering. H 10.5 The system provides the capability to select the drug to be prescribed from pull down menus. H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

27 10.6 The system maintains patient-specific adverse reaction lists and allows on reporting from such lists The system provides the capability for electronic transfer of prescription information to a selected pharmacy for dispensing The system provides the ability to recommend required immunizations and when they are due based on the KEPI immunization schedule. H H H 10.9 The system is capable of preparing a report on a patient s immunization history. H 11 Information Security 11.1 The system supports secure logon into the EMR system. H 11.2 The system controls access to and within the system at multiple levels (e.g. per user, per user role, per area, per section of the chart) through a consistent mechanism of identification and authentication of all users The system verifies and enforces control to all HER/EMR components, information and functions for end users 11.4 The system secures all modes of HER/EMR data exchange through the use of data encryption and destination and source authentication and other standard security methods used to ensure appropriate security and privacy considerations The system incorporates an audit trail for every access, all system transactions including look-ups of patient data. H H H H 11.6 Provides analysis of audit trails and unauthorized access attempts. H 12 Clinical Decision Support & Alerts 12.1 The system includes alerts based on clinical guidelines and protocols at the point of information capture or entry. H 12.2 The alert details include, but are not limited to: Text describing the alert H Date and time of the alert H 12.3 The system allows the user to document rationale for following/not following an alert. H 12.4 The Reminders/Alerts screen pops up whenever a patient record is opened and there are active alerts The system identifies trends that may lead to significant problems and provide prompts for consideration. For example, identifies trends of worsening laboratory results. H H 12.6 The system triggers alerts to providers when individual documented data indicates that H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

28 critical interventions may be required such as change or stoppage of treatments etc The system automatically triggers an alert upon documentation of a diagnoses or event required to be reportable to outside agencies including the MOH, WHO and Centers for Disease Control and Prevention (CDC). H 13 Reporting 13.1 The system allows for the generation of MOH aggregate reports, including disease specific reports for programs such as TB, Malaria and NASCOP, for transmission to the next level such as the District Health Information System (see disease specific section) 13.2 The system electronically transmits aggregate reports to the District Health Information System or any other defined next level using standardized transmission protocols The system creates and maintains patient-specific summary views and reports that include at minimum problem list, medication list, treatment interruptions and restart dates, adverse drug reactions, care history, missed appointments. H L H 14 Chronic Disease Management 14.1 The system supports chronic disease management by: Allowing patient tracking and follow-up H Integrating all patient information within the system H Providing a longitudinal view of the patient medical history H Providing access to patient treatments and outcomes H 14.2 The system tracks / provides reminders and validates care process. For example, the system validates the follow up of a diabetic patient and provides reminders to do blood sugars. H 15 Consents, Authorizations, and Directives 15.1 The system has the capability for a patient to sign consent electronically or store a scanned manually signed consent form The system has the capability to create, maintain, and verify patient treatment decisions in the form of consents and authorizations when required. L L 16 Children s Health 16.1 The system displays the age of a child H 16.2 The system displays growth charts showing plotted values of height, weight, head circumference, and BMI against age and sex data The system allows for capture, storage and management of pediatric specific laboratory tests such as HIV-DNA PCR tests, CD4%. L H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

29 16.4 The system verifies appropriate drug dose for children when given the child s weight in kgs or BSA in cubic meters. H 17 Pregnancy Care 17.1 The system accepts coded input for historical items that are asked at each pregnancy visit such as loss of fluid, foetal movement e.t.c 17.2 Where collected, the system makes Obstetric past history available to the provider for future pregnancies The system records foetal heart rate, fundal height, weight, urine analysis and blood pressure at each visit and the antenatal profile results The system provides for capturing dates to be used for notifications and alerts such as date to start ART prophylaxis, date to schedule for caesarean section, date to perform a check ultrasound etc The system displays the estimated date of delivery (EDD) given the patient s last menstrual period (LMP) The system will calculate an EDD given an ultrasound date and the estimated gestational age (EGA) given by the ultrasound The system creates a printable view of all visits, labs, due date, ultrasound, problem list and plans which can be given to a patient for purposes of communicating with providers on a Labor and Delivery floor. H L H H H L H 18 Orders 18.1 The system supports the recording and tracking of clinical orders and requests such as prescriptions and other treatment orders, laboratory investigation requests, and referrals L 19 Audit/Logging 19.1 The system keeps an audit of all transactions that take place. H 19.2 The system dates and time stamps all entries. H 20 Validation 20.1 The system includes error checking of all user input data, including, but not limited to: Check diagnosis against gender and age H Date checking for validity as well as ensuring a valid chronological order of events (diagnosis before treatment, scheduling after birth, etc.). H 21 Communication 21.1 The system supports the export and import of data received using messaging protocols H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

30 such as HL7 22 Input Mechanisms 22.1 The system uses pre-coded data and selectable choices from dropdowns, where applicable, to minimize data input efforts H 22.2 The system has the ability to allow inclusion of free text H PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

31 3. Exchange of Electronic Health Information Exchange of health information occurs between different systems within a health facility such as between departments, and between ancillary systems, and outside a facility, such as between EMRs and research databases, between health care institutions, and between health service providers and patient care-takers. The ability to exchange health information between systems is referred to as interoperability. As best practice, the PHC EMR interoperability with other systems should take place at three different levels 7. These are: i. Technical Interoperability The ability for different systems to communicate and exchange data based upon well-defined and widely-adopted interface standards. ii. iii. Semantic Interoperability The ability of each system to communicate data and have the receiving system understand the message in the sense intended by the sending system. Policy Interoperability This is the ability of different system to communicate guided by common business policies and processes related to the transmission, receipt, and acceptance of data between them, which a legal framework supports. There will be an administration authority for managing these processes and policies. Health Level 7 (HL7) is the most widely used healthcare information interoperability standard. PHC EMR should use HL7 to exchange health information. Realization of interoperability in PHC EMRs will ensure continuity of care and improved health care services. At a minimum, PHC EMR should: 7 i. Send, receive and store laboratory & diagnostic test results in standardized formats. ii. Differentiate between preliminary and final results, and process corrected results. iii. Send electronic prescriptions iv. Approve medication refills v. Check that medications are on the approved formulary vi. Obtain medication history from the pharmacy system where it exists. vii. Send, receive and store HL7-formatted summaries. 7 M.Mauher, D.Schwarz, R.Stevanović, S.Varga, National, Regional and International Interoperability of Croatian Healthcare Information System. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

32 Interoperability is possible through defined profiles that detail how different systems communicate with each other. The following profiles are relevant to the above desired minimum requirements for interoperability. 3.1 Sharing Medical Summaries Sharing medical summaries is important when referring patients between providers. Medical summaries contain essential clinical information about the patient. Sharing medical summaries is facilitated by HL7 Clinical Document Architecture (CDA) standard. The following are two common use cases of sharing medical summaries: Use Case 1: Clinician to Specialist Referral This use case involves a collaborative transfer of care for the referral of a patient from a clinician to a specialist. This use case is typical of an electronic referral process. Transactions: i. The clinician sees a patient in the office. ii. The clinician examines the patient and decides to refer the patient to a specialist. iii. The clinician sends notification of referral to the specialist iv. The specialist receives the notification of referral v. The specialist locates and retrieves referral documents vi. The specialist views the documents, and has the option to import the data. Use Case 2: Inpatient to outpatient referral This use case involves transferring care from an inpatient facility to an outpatient facility. Transactions: i. The clinician at the inpatient facility generates a discharge summary. i. The inpatient facility sends the discharge summary to the identified outpatient facility. ii. The inpatient PHC EMR notifies all attending providers of the patient s discharge. iii. The outpatient facility receives the discharge summary, with the option to import data into the EMR system. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page

33 3.2 Distributed Patient Management It is important to coordinate patient information across systems, because patients interact with the health care system at different points. The following use case illustrates typical coordination of patient information between systems. Use case 1: Updating patient s records from outside the PHC EMR In this use case, a patient provides updated information to the pharmacist. The updated information is then reflected in the PHC EMR. Transactions: i. Patient gives new telephone number to the pharmacist ii. Pharmacist edits the patient s contact information in the pharmacy system iii. The pharmacy system sends updated contact information to the PHC EMR iv. The PHC EMR accepts and updates the patient s contact information. v. The PHC EMR sends out a notification that the patient s contact has been updated. 3.3 Centralized Patient Management Centralized patient management allows multiple distributed PHC EMRs to query a central patient information server. Use Case 1: Creating patient record using central patient information server This use case describes querying the centralized patient information server to automatically populate a new patient record. Transactions: i. Registration clerk searches for patient on PHC EMR but finds no matching record ii. Registration clerk searches for patient on centralized patient information server and finds a matching record. iii. Registration clerk selects the matching record for import into PHC EMR iv. The PHC EMR uses the selected record to create the new patient. PRIMARY HEALTH CARE EMR STANDARDS AND GUIDELINES Page