CLS > ABOUT US

Saturday, April 20, 2024

ABOUT US
STAFF
ACCREDITATION
SERVICES

ABOUT US

ABOUT US

Company Profile

Clinical Laboratory Services (CLS) is a division of the Wits Health Consortium of the University of the Witwatersrand School of Pathology, Johannesburg South Africa.

It was established in the year 2000 by the Head of Research at CLS, Prof Wendy Stevens to offer diagnostic laboratory services for clinical trials, research studies and hospitals linked to the academic complex.

As CLS is committed to supporting research and ensuring we have a strong academic link. All revenue generated at CLS is fed back into the School of Pathology to grow all disciplines of pathology and research within the University of the Witwatersrand.

Wits Pathology, the division of CLS dealing with private patients, was opened on the 8th January 2004.It is positioned to offer a specialized diagnostic pathology academic service to the clinician and provide a professional, caring environment to the patient.

The DGMC (Donald Gordon Medical Centre) is geared to offer super specialty medicine such as Oncology, Surgery, Hepatology, Nephrology, Medicine, Orthopaedics and Transplantation.

The academic Transplant division headed by Prof Russell Britz/Prof Jean Botha is in line with international standards and adheres to the International criteria.

Wits Pathology is an integral part of the Transplant Team. Rotation of senior registrars, overseen by Consultants, through DGMC as a teaching exercise, exposes the registrars to new elements in medicine, preparing our Wits Graduates to the needs of the private pathology market.

Wits Pathology was involved in the first Pancreas after Kidney (PAK) transplant in Johannesburg. Recently the first pediatric Related Liver Transplants (mother to child) were performed.

Wits Pathology together with the Immuno Haematology Department of the University of Witwatersrand, are amongst the leaders in Virtual Cross Matching for renal transplants.

Our Values

- Professionalism

- Excellence

- Expertise

- Passion

Location

The CLS core lab is located in Johannesburg which is the flight hub to the rest of Africa making access to clinical laboratory sites easy and more cost effective than other centers. CLS also has a hub in Greenpoint Cape Town. CLS has logistic capabilities to provide its services throughout the country. More ...

STAFF

STAFF

Pathologists

A team of specialized pathologists from the Wits University School of Pathology are available for consultation and troubleshooting when required.

Technical Team

CLS has a comprehensive team of senior technical staff both on site and also available in the in laboratories at the Johannesburg hospital complex and School of Pathology that are available to provide advice and support when required. Staff is well versed with requirements for laboratory accreditation and the principles of Good Laboratory Practice.

Clinical Trials Project management

CLS also has a dedicated Clinical Trials team with project managers and co-ordinators that assist with study set-up, maintenance, trouble shooting and communication with clinical sites and the laboratory.

CLS Support Projects

Currently at CLS we have a team of support projects managers involved in the CLS lab support program. Essentially involved in the initiation of the studies through to study completion. To ensure that the testing is conducted in accordance with GCLP standards.

ACCREDITATION

ACCREDITATION AND AFFILIATION

Accreditation And Affiliation

• ISO 15189 accreditation for all our laboratory divisions is maintained through the South African National Accreditation System (SANAS) and has been maintained since 1999.

• GCLP accreditation has been attained through the British Qualogy Group.

• CLS Johannesburg laboratories, the Specialty laboratories (Viral Load, CD4 and Genotyping) and CLS Cape town are DAIDS approved through PPD and FHI monitoring.

• CLS repository is IATA and LDMS certified.

Collaboration

Several close collaborations have been established with a number of research and clinical trial networks including:

• Clinical Trial Networks

- Adult AIDS Clinical Trials Group (ACTG) (NIH funded)

- Pediatric AIDS Clinical Trial Group (IMPAACT) (NIH funded)

- HIV Prevention Trial Network (HPTN)

- HIV Vaccine Trial Network (HVTN)

- CIPRA

• Microbicides Networks:

- Microbicides Development Program (MDP)

- International Program for Microbicides (IPM)

- Micobicides Trials Network (MTN)

• Follow – on African Consortium for Tenofovir studies (FACTS)

• TB Alliance: REMOX TB

• Otsuka group (TB studies)

• Bill & Melinda Gates Foundation

• International HIV/AIDS Vaccine Initiative (IAVI)

• Malaria Vaccine Initiative (MVI)

• Glaxo Smith Kline Biologicals (GSK)

• SPARTAC (Imperial College, UK – Wellcome Trust)

• PASER

• PROMISE

• H3 AFRICA

SERVICES

OVERVIEW OF THE CLS LABORATORIES

Overview

• CLS has 2 laboratories with the main laboratory based in Braamfontein Johannesburg and provides a complete profile of clinical pathology tests and has access to refer specialized tests to the School of Pathology including CD4, HIV viral load testing, HIV genotyping testing, specialized Microbiology as well as Histopathology and Cytology.

• Our satellite laboratory located in Cape Town are equipped to function as a class II facility, and therefore have the capacity to isolate peripheral blood mononuclear cells (PBMC). .

• Both laboratories have capacity for sample storage at -80°C and LN2 and are equipped with the LDMS system and the LIMS system that is linked to the host system in Johannesburg.

Safety Analytical Laboratory

The laboratory uses both manual and state of the art automated testing which is FDA approved. The laboratory follows strict quality control measures, adhering to turn-around-times to maintain high standards. Our Internal Quality Control (IQC) is monitored daily, weekly and monthly and reports are completed ensuring continuous monitoring and evaluation in our quality.

The laboratory processes clinical trial samples only and therefore complies with national and international accreditation standards, as well as participates in a number of local and international EQA programs.

The lab has dedicated areas for processing a large number of clinical samples for Haematology, Chemistry, Immunochemistry and Serology assays.

PBMC Laboratory

CLS has 2 PBMC laboratories strategically placed in Cape Town and Johannesburg. Automated counting is available as method of choice for cell enumeration. The laboratory has highly experienced personnel who understand the requirements from various networks. CLS has provided PBMC training to African sites in Uganda, Mozambique, Kenya and Zambia as well as locally.

Services

• PBMC cryopreservation

• ELISPOTS

• Lymphocyte proliferation

• PBMC Leukapheresis

CLS participates in extensive proficiency testing programs

• ELISPOT Proficiency Testing

• ACTG proficiency testing Immunology Quality Assurance program

• HVTN proficiency program: CHAVI QA/QC program

• CLS Quarterly QC

Your Clinical Trial Training Provider

CLS has a long history of providing training for local laboratories as well as laboratories in other parts of Africa and India. A significant amount of development work has gone into the appropriateness of the training programs focusing on Good Clinical Laboratory Practice (GCLP).The training program is CPD accredited by the SMLTSA which is an HPCSA PBMT appointed accreditor. Lecture halls and seminar rooms are available for the didactic teaching required for training. These rooms are equipped with appropriate audio-visual equipment such as data projectors, overhead projectors, flip charts and internet/e-mail connections. Easy access to suitable reference libraries is available at the University of Witwatersrand.

The following clinical trial related training courses are offered by CLS:

Good Clinical Laboratory Practice

Duration: 3 days

This CPD accredited course offers delegates comprehensive theoretical and practical insight into GCLP principles enabling delegates to go back to the workplace and make meaningful, practical changes to their daily settings.

The overall aim of the course:

- To introduce delegates to the concepts and application of GCLP

- Outline practical steps implementing guidelines into clinical trial laboratory settings

- Differentiate between clinical trial laboratory requirements and normal routine laboratory

practice.

GCLP refresher is recommended every 2-3 years.

CLS also offers GCLP refresher training and this is also CPD accredited.

Phlebotomy Training

This one day course provides delegates with hands on practical and theoretical knowledge on Basic Phlebotomy. This course is perfect for study nurses, phlebotomists and PHC workers. Regardless of your experience, this course offers a perfect refresher.

Hands on PBMC Training

CPD accredited

Duration: 3 – 5 days*

CLS is one of the very few providers on training in PBMCs and ELISPOTS. We train delegates on methods that are required and offer competency certificates.

*depending on method required

Sample processing training

Duration: 1 day

Course outline:

• Overview of sample collection, order of blood draw and sampling instructions

• Requisition forms

• Sample stability

• Tests done at the site

• Centrifugation – sample separation at the site lab

• Pipetting/aliquoting samples

• Centrifuge – safety and maintenance

• Storage of samples at site

• Sample packing and transport from site to lab – Responsibility of the shipper

• QC process

• Results

• Chain of custody

• Abnormal results

• Adverse events