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

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

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

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

• 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

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.

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

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

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.

Screenshots Clinical Protocol

Manager

Screenshots Clinical Protocol

Manager

Screenshots Clinical Protocol

Manager

Screenshots Clinical Trial

Manager

Screenshots Clinical Trial

Manager

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

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

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.

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

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

Generation of Pathology Reports

cont..

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.

HPRU LABORATORY STAFF

THANK YOU