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NEIL MANSELREDDY
HIV PREVENTION RESEARCH UNIT
SOUTH AFRICAN
MEDICAL RESEARCH COUNCIL
Labware Customer Education Conference
09 September 2014
Research Pathology Lab Software
6 years in the making
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Overview of MRC
The South African Medical Research Council (SAMRC) was established in 1969 with
the aim to deliver on a mandate to promote the improvement of health and the
quality of life of the population of our country through research, development and
technology transfer.
The scope of the SAMRC’s research includes basic laboratory investigations,
clinical research and public health studies. Research at the SAMRC focuses on the
top ten causes of death in South Africa and includes TB, HIV, burden of disease,
chronic diseases, alcohol and drug abuse and women’s health.
Our Vision – Building a healthy nation through research and innovation
Our Mission – To improve the nations health and quality of life through promoting
and conducting relevant and responsive health research
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Overview of HPRU
The HIV Prevention Research Unit (HPRU) is based in Durban under the leadership
of Professor Gita Ramjee.
The Unit’s mandate is to address women’s vulnerability to HIV through a
comprehensive research program consisting of epidemiological, behavioural, basic
science and clinical studies.
Women remain at the highest risk of HIV infection in South Africa, and their
vulnerability to HIV can be attributed to a number of risks including biological,
behavioural, social and structural factors.
In addition, they have increased vulnerabilities to other HIV related co-morbidities
such as TB
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Our priority areas are:
• To address behavioural, social and structural vulnerabilities to HIV among women.
• To address biological vulnerability of HIV among women by conducting research on
HIV and associated co-morbidities including communicable and non-communicable
diseases.
• To undertake clinical research for novel biomedical interventions by conducting
multi-disciplinary biomedical HIV prevention research through pre-exposure
prophylaxis, vaccines, combination prevention strategies and operational research.
Overview of HPRU continued
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• To undertake research of combination HIV prevention, treatment and care
strategies by developing innovative laboratory and point of care diagnostics to
enhance and support the Health Systems.
• To address women’s access to better and integrated Health Systems through
operational and implementation science research by collaborating with the
Department of Health to strengthen and support health systems delivery through
research translation.
Overview of HPRU continued
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How Does Labware Fit in with HPRU
• Labware is used for reporting and generation of pathology reports for participant
results
• 21 CFR (Code of Federal Regulations) establishes regulations on electronic records
and electronic signatures
• Labware is 21 CFR Part 11 compliant
– Part 11 allows companies to implement computer systems that will greatly
increase efficiency of individuals, reduce errors by identifying risks and
increase overall productivity of the company.
– With the implementation of these processes, Part 11 allows any paper record to
be replaced with an electronic record provided the computer system has
appropriate features and is validated.
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There are three primary areas:
• SOP’s – To address data back-up, data security, computer system validation and
other aspects of computer systems that support electronic records and signatures
• System failures – To ensure that the computer system is secure, contains audit
trails for data values and ensures integrity of electronic signatures
• Computer system validations – every computer must have documented evidence
that the system does what it is intended for and users can identify when the system
is not working as intended.
• Labware fits in with the analytical (testing) and post analytical (reporting of test
results) components of our chain of custody.
How Does Labware Fit in with HPRU
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Features in Labware used in
Research Pathology
There are a few main foundation features on which we base our use:
These include:
Clinical Protocol Manager
Clinical Trial Manager
Inventory Manager
Instrument Manager
Order Manager
Alert Manager
Batch Manager
Charge Module
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Clinical Protocol and Trial Manager
Clinical Protocol Manager
This feature is used for the set-up of new studies
It defines exactly what the protocol requires (name of the protocol, visits and visit
codes, required tests, sample types, allocation of samples to benches) and all
information is captured on this module.
Due to Labware’s versatility it allows for the system to be configured to user
specific requirements.
Clinical Trial Manager
This feature is also used for the set-up of new studies which defines which sites we
want to conduct the study at
The number of participants we want to enroll at each site and all information is
captured in this module.
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Screenshots Clinical Protocol
Manager
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Screenshots Clinical Protocol
Manager
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Screenshots Clinical Protocol
Manager
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Screenshots Clinical Trial
Manager
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Screenshots Clinical Trial
Manager
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Reference ranges are critical at HPRU
This is required for all quantitative analyses
All reference ranges are configured in the reference range manager on Labware
This is configured per protocol and per analyte
The module also captures panic values as well as the division of AIDS (DAIDs)
grading which is grading of results which will define the severity of that result
Panic results are sent out via coretalk, a sms software which is configured to
Labware and is used to inform key personnel of the panic result to ensure
participant safety and treatment as soon as possible.
Reference Ranges
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Monitoring of stock and Calibration of
instruments
Labware is also used to monitor stock control in the inventory manager.
Calibration of equipment is also monitored, and updated regularly
If the calibration is not updated, interfaced instruments will not work (this has been
noted from the support help desk) and this is the first point of troubleshooting
when results are not interfaced
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Outloads and Stats
Outloads and Stats are important in research and this can be easily retrievable from
Labware based on the stored queries that can be done by the user specific
requirements
Monthly stats and management review outloads assist us with overall laboratory
productivity which is monitored on a monthly basis
Outloads can be performed on the information you would want to obtain, an
example of this would be is if you want to obtain all the Hb results of patients for a
particular time period for monitoring purposes or another example would be to
obtain all the date of births of all patients to assess the age groups that has been
enrolled into the study.
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Charge Module
The Charge module assist us with the journals and spreadsheets that are completed on a
monthly basis for the laboratory which is billed for each test per customer
It gives a clear indication for income generation and overall productivity of the laboratory
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Generation of Pathology Reports
Once all results are entered, a pathology report is generated using the scheduler
Crystal report software is used for generation of the reports
Once reports are printed and quality controlled, all reports are dispatched to the
relevant sites
There is a system in place to send out e-versions of the reports to a stipulated list
of staff members
Each analyte/test has Turn Around Times (TATs) which is strictly adhered to
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Generation of Pathology Reports
cont..
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Troubleshooting and Support
Natalie Bently and her support team are exceptional when it comes to issues that
we are faced with
For the period of 2012 to date, we have logged 28 Support calls that we had
required Labware to assist with.
There are quick TATs on resolutions and queries
Examples of the challenges we have encountered include:
reference ranges missing
System upgrades
Reporting of results
Age calculations
reports not printing
interface queries, times on reports
study set-up problems etc.
From 2012 to date, the number of support issues has decreased with staff attending
training and being more efficient and confident on working with the software
My personal experience is that the training has vastly improved my working
capabilities on the software and I am more confident on working on the software.
The Lessons we have learnt is that we need to troubleshoot all possibilities before
we log a call with support, we need to be precise when logging a support call,
admin staff require Labware admin training and when logging calls with support
supply the relevant logs and screenshots where applicable.
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HPRU LABORATORY STAFF
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THANK YOU