NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES (NICD)
Notifiable Medical Conditions (NMC)
Mobile Lab SurveillanceSolution
Functional RequirementsDocument
Contents
Purpose of the Document 3
Introduction 3
Introduction 3
Problems (Gaps) 4
Solution Scope 4
In Scope 4
Glossary 6
Process Flow 7
NMC LAB SURVEILLANCE PROCESS FLOW 7
Monitoring Process Flow 8
Functional Requirements 9
User Interface 19
Reporting - List of Required Reports 27
Security & Deployment 29
Training Approach – Classroom or Instructor Led 30
Test Approach - V Model Testing 30
The ‘V’ Model 31
Recommendations 32
Purpose
The purpose of this document is to provide a description of the full functional requirements, technical designs and process flows for the NMC lab surveillance system in order to provide a comprehensive overview of the proposed system.
In addition, the document describes the limited scope of the pilot system that will be developed and tested prior to developing the full system.
Introduction
The objectives of the NMC lab surveillance system is as follows:
· Develop an integrated and efficient real time alert system that will allow timeous notifications (alerts) to be sent to all relevant people (NMC Core Team, CDC (local, district, province, national), Facility NMC Focal Person, Outbreak Response Unit focal people (NICD)) when any one of the notifiable medical conditions is diagnosed in all public or private laboratories across the country.
· Develop a real time alert system that provides a platform for Health Facilities, NMC Core Team and Public Health Surveillance personnel to capture required clinical and public health data relating to NMCs.
· Develop a system that audits and monitors all communication and interaction with the system. This monitoring relates to delivery of alerts and the interactions between the different role players and the system
· Develop an alert system that merges clinical data from Health Facilities with Laboratory data within the Corporate Data Warehouse.
· Provide reports at different levels of granularity i.e. summarized data for Management Reporting and detailed data for Operational Reporting to monitor and track actions taken for identified pathogens.
Problems (Gaps)
The drivers of this project are defined below:
There is no current comprehensive, efficient and integrated system for real-time reporting of diseases of public health importance and data management, analyses and dissemination thereof. Current processes lack coherence, have considerable time lags and most of all, lack utilization at all levels and do not capitalise on technological advancements. Additionally there is no integration of clinical and laboratory generated data to provide holistic notifications incorporating data from these sources. This projectaims to develop a solution that builds upon existing systems to develop a data network that can capture and disseminate timely and reliable surveillance data for public health actions and decision making.
Solution Scope
In Scope
· Receive External Data from Laboratories and upload it to NMC Data Mart within CDW
· Receive External Clinical Data from Mobile devices and other data capture systems such as the District Health Information System (DHIS) and upload it to NMC data mart within CDW
· Merge clinical data and lab data to provide complete patient data.
· Create triggers based on business rules to send real-time SMS/email alerts to relevant people as and when any one of the Notifiable Medical Conditions (NMC) is detected by clinical or laboratory based diagnosis
· Monitor and Audit the delivery of alerts
· Monitor and audit the acknowledgement of alerts
· Allow for additional data capturing as required using a mobile device
· Monitor and audit recipient interactions with the system
· Store and aggregate data at different levels of granularity for reporting purposes
· Develop and distribute operational and management reports to relevant people
Glossary
CDC – Communicable Disease Control
CDW – Central Data Warehouse
DHIS- District Health Information System
ETL – Extract Load and Transform
GIS - Geographic or Geospatial Information System
NHLS – National Health Laboratory Services
NICD – National Institute for Communicable Diseases
NMC - Notifiable Medical Conditions
ORU – Outbreak Response Unit
Relevant peoplerefers to NMC Core Team, CDC (local, district, province, national), Facility NMC Focal Person, Outbreak Response Unit focal people (NICD)
Process Flow
NMC LAB SURVEILLANCE PROCESS FLOW
Monitoring Process Flow
Functional Requirements
System Requirement ID: / SR_01System Requirement Name: / Receive External Data from Private Labs and upload it to NMC Data Mart within CDW
Related Business Requirement / None
Use Case ID / SR_01
Use Case Name / Receive External Data from Private Labs and upload it to NMC Data Mart within CDW
Priority / High
Source / Data received from Private Labs
Primary Business Actor / Private Lab
Description / This functionality provides a platform where all NMC cases diagnosed in any private laboratory can be imported into the NMC national data mart within CDW. Laboratory diagnosis comprises of positive and negative results for NMC pathogens as per defined case definitions.
Precondition / · Near real time data dump comprising of agreed data elements from the private laboratories into CDW
· Data is extracted, transformed and loaded into NMC Data Mart, if data fails to upload CDW ETL Team is tasked to resolve the technical issues.
· Origin of Data is registered on NMC Data Mart
Trigger Alert / · Uploaded data is checked for positive results as per case definition
Typical course of events / 1. Near real time Private Lab Data comprising of required data elements for notification is received and registered
2. Data is extracted, transformed and loaded into NMC Data Mart, if data fails to upload CDW ETL Team is tasked to resolve the technical issues.
3. Uploaded data is checked for positive results as per case definition
4. Upon positive results confirmation, relevant people receive an Alert via SMS or Email with the positively identified Pathogen. Within this SMS and/or Email alert will be link that when opened confirms receipt and acknowledgement of alert contents. The SMS and/or Email alert will contain all required data elements as per the notification data elements. Where data is missing, it will be marked as such. If clinical data is available, the SMS and/or Email alert will contain both laboratory and clinical data.
5. A delivery report is sent (to the NMC Core Team)when the SMS and/or Email alert has been successfully delivered. The delivery report is stored in the NMC Data Mart for tracking and reporting on successful / failed alerts.
6. Relevant people open the link to acknowledge receipt and contents of the alert.
7. The acknowledgement receipt is stored in the NMC Data Mart for tracking and reporting on acknowledgements of alerts.
8. Once the link is accessed from point 6 above, a form is opened with prepopulated data from the Laboratory diagnosis. If clinical data is available, the prepopulated data will contain both clinical and Laboratory data.
9. If the notification/alert only contains laboratory based data without clinical data, additional clinical data will be captured by the facility focal person.
10. Upon completion of data capturing, the data will be submitted to the NMC data mart by clicking the ‘submit’ button.
11. Upon successful submission of the additional data,the system will generate and send an acknowledgement of data submission to the person who captured / submitted the data.
12. Upon successful data submission and acknowledgement, Laboratory Data and clinical data is merged. The key used to merge the data will be the Specimen Bar Code plus all unique patient and facility details.
13. If there are missing fields in the alert/notification that require additional data and additional data is not captured for 3 days or more, a follow up report(SMS and/or Email) is generated to the NMC Core Team.
Conclusion (Success scenario) / After submitting the form with additional data, a short data submission confirmation message on the member’s mobile device is generated, to acknowledge and thank the submitter. “Acknowledgement Message will be provided as development happens”
The process is complete once a complete patient record has been captured in the NMC Data Mart for all the NMCs and when alerts from NMC Data Mart has successfully been sent to relevant people
Post-condition / None
Business Rules / The key to merge the data will be the Specimen Bar Code plus all unique patient and facility details.
Note:Additional business rules will be defined during system design e.g. mandatory fields
Implementation constraints and specifications / Private Lab Data Dump must be fed to the NMC Data Mart at as near real time frequency as possible
System Requirement ID: / SR_02
System Requirement Name: / Receive Data from NHLS or NICD and upload it to NMC Data Mart within CDW
Related Business Requirement / None
Use Case ID / SR_02
Use Case Name / Receive Real Time Data from NHLS or NICD and upload it to NMC Data Mart within CDW.
Priority / High
Source / Data received from NHLS or NICD
Primary Business Actor / NHLS or NICD Laboratories
Description / This functionality provides a platform where all NMC cases diagnosed in any public laboratories can be imported into the NMC national data mart within CDW. Laboratory diagnosis comprises of positive and negative results for NMC pathogens as per defined case definitions.
Precondition / · Specimen is received in the laboratory from Health Facilities and logged onto LIS
Trigger Alert / · Specimen is tested and provisional results generated within the LIS(real time provisional results will be uploaded to NMC Data Mart) Provisional positive results triggers an alert / notification to NMC core team.
· Final results generated (real time Final results will be uploaded to NMC Data Mart). Final positive results triggers an alert / notification to all relevant people
Typical course of events
(Main Success Scenario –Provisional and Final Results) / 1. Specimen is received from Health Facilities and logged onto LIS
2. Test requested for is checked against super list to verify if pathogen/condition tested for, falls under super list.UponSuper List confirmation, NMC Core Team receives an Alert via SMS or Email with the provisional results for the identified Pathogen and waits for the final results. The SMS will contain a minimum dataset with patient data and test request details.
3. A delivery report is sent (to the NMC Core Team) when the SMS and/or Email alert has been successfully delivered. The delivery report is stored in the NMC Data Mart for tracking and reporting on successful / failed alerts.
4. NMC Core Teammember opens the link to acknowledge receipt and contents of provisional results alert.
5. The acknowledgement receipt for test requestedis stored in the NMC Data Mart for tracking and reporting on acknowledgements of provisional results alerts.
6. Laboratory test is conducted and provisionalresults generated.
7. Provisional results are uploaded to the NMC Data Mart within CDW.
8. Provisional results are authorized and Final results are generated.
9. Final results are uploaded to the NMC Data Mart within CDW. Relevant people receives an Alert via SMS or Email with the positively identified Pathogen. Within this SMS and/or Email alert will be a link that when opened confirms receipt and acknowledgement of alert contents. The SMS and/or Email alert will contain all required data elements as per the notification data elements. Where data is missing, it will be marked as such.
10. If clinical data is available, the SMS and/or Email alert will contain both laboratory and clinical data.
11. A delivery report is sent (to the NMC Core Team) when the SMS and/or Email alert has been successfully delivered. The delivery report is stored in the NMC Data Mart for tracking and reporting on successful / failed alerts.
12. Relevant people open the link to acknowledge receipt and contents of the alert.
13. The acknowledgement receipt is stored in the NMC Data Mart for tracking and reporting on acknowledgements of alerts.
14. Once the link is accessed from point 9 above, a form is opened with prepopulated data from the Laboratory diagnosis. If clinical data is available, the prepopulated data will contain both clinical and Laboratory data.
15. If the notification/alert only contains laboratory based data without clinical data, additional clinical data will be captured by the facility focal person.
16. Upon completion of data capturing, the data will be submitted to the NMC data mart by clicking the ‘submit’ button.
17. Upon successful submission of the additional data, the system will generate and send an acknowledgement of data submission to the person who captured / submitted the data.
18. Upon successful data submission and acknowledgement, Laboratory Data and clinical data is merged. The key used to merge the data will be the Specimen Bar Code plus all unique patient and facility details.
19. If there are missing fields in the alert/notification that require additional data and additional data is not captured for 3 days or more, a follow up report (SMS and/or Email) is generated to the NMC Core Team.
Conclusion (Success scenario) / After submitting the form with additional data, a short data submission confirmation message on the member’s mobile device is generated, to acknowledge and thank the submitter. “Acknowledgement Message will be provided as development happens”
The process is complete once a complete patient record has been captured in the NMC Data Mart for all the NMCs and when alerts from NMC Data Mart has successfully been sent to relevant people
Post-condition / None
Business Rules / The key to merge the data will be the Specimen Bar Code plus all unique patient and facility details.
Note:Additional business rules will be defined during system design e.g. mandatory fields
Implementation constraints and specifications / Real time NHLS / NICD Laboratory Data must be fed to the NMC Data Mart
System Requirement ID: / SR_03
System Requirement Name: / Receive External Data from Health Facilities and upload it to NMC Data Mart
Related Business Requirement / None
Use Case ID / SR_03
Use Case Name / Receive External Data from Health Facilities and upload it to NMC Data Mart
Priority / High
Source / Data received from Health Facilities
Primary Business Actor / Health Facilities