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About CLSI

 

Assisting Laboratories in Countries Around the World

GHP staff and volunteers travel the globe to give resource-constrained laboratories the tools and training they need to succeed.

We are currently providing support programs to laboratories all over the world. Hover over the highlighted map markers to learn where; click on the marker to learn more about our involvement at that location.

GHP World Map

Program Locations

While GHP is always expanding its support services to new areas, we have assisted or are currently providing programs to laboratories in the following locations:

Central Asia

CLSI’s technical assistance visits in Central Asia started in late 2010. During 2015, CLSI planned and conducted a series of two Quality Manager Training Workshops designed to enhance the skills of Quality Managers and encourage advocacy for development and implementation of quality by Laboratory Directors. Workshop one was held in Almaty in May and workshop two was held in Astana in October. A total of 30 participants were trained, representing both Kazakhstan and Kyrgyzstan. In June, the last in a series of assessment and mentoring visits were conducted at the Republican Blood Center in Almaty and the West Kazakhstan Oblast Laboratory in Oralsk. Similar assessments were performed by a CLSI team at the HIV Reference Laboratory of the Republican AIDS Center for the Kyrgyz Republic in Bishkek and HIV Diagnostics Laboratory of the Osh Oblast AIDS Center for the Kyrgyz Republic in Osh, in July 2015. In each case, the SLIPTA checklist was used as the assessment tool.

In 2016, our work expanded into Uzbekistan. A series of laboratory assessor trainings were conducted and technical support for the implementation of QMS and accreditation preparation will be provided to the Republican AIDS Center and Institute of Virology in 2017.

Dominican Republic

The first Global Health Partnerships’ CDC supported laboratory strengthening activities in the Western Hemisphere began in the Dominican Republic in 2016. Mentoring and training events are designed to support the CDC focus on improving the quality of viral load testing and HIV Rapid Testing. CLSI works with the National Reference Laboratory and 5 point of care laboratories throughout the country.

Ethiopia

Ethiopia was one of CLSI’s first sites for PEPFAR programming. Beginning in 2008, with assessments and procedure writing workshops, CLSI has worked closely with the Ethiopia Public Health Institute (EPHI) and CDC to provide QMS workshops reaching audiences from laboratory technicians to hospital administrators, and training assessors to monitor quality improvement in laboratories throughout the Ethiopian laboratory system. More recently, mentoring at EPHI and regional laboratories focuses efforts on preparing the laboratories for accreditation to ISO 15189 by the Ethiopia National Accreditation Organization (ENAO).

In 2016, CLSI launched a new activity supporting a professional exchange between laboratories working toward accreditation and a lab that had achieved and maintained accreditation to ISO 15189. Representatives from the CLSI supported Ethiopia laboratories travel to Dar es Salaam, Tanzania, to visit the National Health Laboratory Quality Assurance and Training Center. The NHLQATC was the first CLSI-supported laboratory in Tanzania to achieve international accreditation to ISO 15189.

The exchange visit provides an opportunity for the visitors to see a fully functional QMS system, operating in compliance with international standards in a work environment similar to their own. They have the chance to talk to laboratory professionals about the journey to accreditation and ask questions about specific challenges they are facing.

India

CLSI’s Global Health Partnerships returned to South Asia in 2016, conducting laboratory strengthening activities in India. Initial activities included assessments of Point of Care testing (POCT) sites using a checklist developed by the India National AIDS Control Organization (NACO). This was followed by a workshop training local laboratory staff to conduct POCT site monitoring using the NACO checklist.

Continued programming supports the current WHO/CDC focus on improving the quality of viral load testing and HIV Rapid Testing.

Kenya

2013 – CLSI’s Global Health Partnerships staff and Board of Directors President Mary Lou Gantzer, PhD, FACB, are working with the Kenya Medical Technicians and Technologists Board to launch an ambitious program to validate laboratory equipment and reagents as they enter the country. The scope of this validation project is unprecedented among the developing countries in the region.
After an initial meeting in January 2013, Dr. Gantzer and GHP Director Fran Ingersoll returned to Kenya in April 2013 to conduct a validation workshop and provide technical assistance to the board as its members develop the program’s policies and procedures. They will travel to Kenya again in August 2013 to lead workshops for managers in the labs selected as potential validation sites.

In 2014, CLSI was invited by CDC in Kenya to start offering technical assistance to six laboratories (Bomu, Kisii, Kisumu, Migori, PCEA Chogoria and Meru) in order to implement QMS toward international accreditation. In pursuant to this task, in March 2014, CLSI conducted baseline gap assessments at the laboratories and developed work plans to implement the identified gaps. In order to build local capacity in mentoring, CLSI hired and trained two local contract mentors. These mentors partnered with two CLSI international expert mentors to conduct mentorship programs at the targeted laboratories. The mentorships focused on; developing QMS documents that comply with the ISO 15189 standards, implementations of the documented procedures and monitoring the implementation for opportunities for improvement. Each mentorship episode lasted for a minimum period of two weeks. In April 2015, Bomu attained international accreditation aligned to ISO 15189 standards after a successful assessment by Kenya Accreditation Services (KENAS). Bomu has successfully maintained its accreditation status to this day. Technical assistance to Meru L5 Laboratory was suspended due to lack of support of the program by the county laboratory leadership.

By the end of 2015, CLSI’s technical assistance had been extended to 5 additional laboratories (KEMRI-Alupe, KEMRI-Nairobi, Kenyatta National Hospital-Hematology, Kenyatta National Hospital-Blood Transfusion Unit and AMPATH Care Plus). In order to cope with the additional number of laboratories, CLSI hired and trained two more local mentors. At national level, CLSI also built local capacity to implement QMS through training of local mentors (46) and mentor Trainer of Trainers (15).

In 2016, in addition to assisting 10 laboratories toward international accreditation, CLSI also started working with KENAS to build the capacity of the organization in offering accreditation to ISO 22870 and ISO 15195. CLSI subject matter experts conducted four training workshops to KENAS staff (66) on understanding the basic concepts of the two ISO standards. Through the trainings, KENAS was able to constitute a pool of auditors and technical committees that oversee the assessments aligned to these standards. In August 2016, KENAS was able to launch its POCT (ISO 22870) accreditation program. At national level, CLSI conducted the following workshop: Mentor Training Workshop (24), two QC and Method Validation Workshops (47), and two SLMTA workshops (49). By end of December 2016, Bomu has successfully maintained accreditation while six more laboratories (PCEA Chogoria, Kisii, Migori, Kisumu, KEMRI Alupe and AMPATH Care Plus) achieved international accreditation aligned to ISO 15189 standards.

Additionally, CLSI set-up a regional office in Nairobi which offers support to the country activities. The office is managed by a Program Manager who is a qualified laboratorian with extensive program management experience. This office will coordinate and support the pool of local mentors with adequate resources to carryout their mandate.

Mozambique

Since 2010, CLSI Global Health Partnerships provided QMS training and support to a variety of audiences in Mozambique. Educational sessions include basic QMS workshops, offered to hospital laboratories and national blood center laboratories, and the CLSI Quality Manager Training program. The National Institute of Health – External Quality Assessment Program has been assisted help them move toward accreditation to ISO 17043.

Most recently laboratory strengthening mentoring was provided to the Maputo Central Hospital Laboratory. An element of the support was the sponsorship of the laboratory director and quality manager to participate in a professional exchange to Lisbon, Portugal, to visit accredited laboratories. The professional exchange concept was initiated by CLSI in Ethiopia in 2016.

CLSI programming continues in Mozambique by providing support to the Ministry of Health to develop, review and revise key laboratory policy documents, ensuring compliance with current international recommendations and standards.

Namibia

CLSI has been working with Namibia Institute of Pathology (NIP) in collaboration with CDC Namibia to strengthen and build local laboratory capacity to implement and sustain quality management systems since 2008. Through this collaborative effort, the NIP Reference Laboratory (Windhoek Central Reference Laboratory) successfully attained accreditation aligned with ISO17025 in October 2010. This laboratory has maintained this status since then. Ongoing activities have seen four more laboratories (Keetmanshoop, Otjiwarongo, Oshakati and Rundu) under NIP attaining different levels of recognition after ASLM assessments in July 2013. Rundu and Oshakati laboratories are expected to achieve accreditation by end of 2017.

In 2014, CLSI partnered with ASLM to conduct gap assessment at eight laboratories across the country. The results of the gap assessments were instrumental in the programming activities for laboratory strengthening initiatives under the CDC Namibia in collaboration with the Ministry of Health and Social Services.

In 2015, CLSI again partnered with ASLM to conduct the following workshops: Mentor Training Workshop (25) and QMS for Managers Workshop (21). These workshops were instrumental in helping laboratory professionals in the country to understand their role in QMS implementation.

In 2016, CLSI in collaboration with ASLM, CDC Namibia and Ministry of Health and Social Services revised and review the National Point of Care guidelines Namibia. A final draft document of the guidelines was developed and submitted to the Ministry of Health and Social Services for approval.

Tanzania

2013 to 2014 – CLSI conducted targeted and focused four-week mentor programs at six laboratories (Bugando Medical Center, Mnazi Mmoja in Zanzibar, Mbeya Referral, Muhimbili National, National Health Laboratory Quality Assurance Training Center – NHLQATC, and Kilimanjaro Christian Medical Center). In these mentorship programs, CLSI expert mentors spent up to four weeks working side-by-side with local laboratorians, coaching and teaching them on how to implement standards-based quality. These mentor programs were targeted at either implementing the developed QMS or upgrading the documentation to comply with the ISO 15189:2012 version of the standard. By April 2014, the NHLQATC achieved international accreditation aligned to ISO 15189 standards after being assessed by Southern African Development Community Accreditation Service (SADCAS).

In order to ensure that accredited laboratories can maintain their accreditation statuses, CLSI conducted a 5-day Maintaining Accreditation Workshop whose aim was to train quality officers and lab managers on the skills needed to maintain and sustain QMS in order to maintain accreditation. This workshop was attended by 24 laboratory managers and quality officers mainly from the six laboratories under CLSI technical assistance.

At the beginning of 2015, CLSI technical assistance was extended to support four additional laboratories (Aga Khan, Kibong’oto TB Reference, Temeke Municipal and Ndanda Referral). Around the same time Muhimbili National Hospital Laboratory also achieved international accreditation. A baseline gap assessment was conducted at each laboratory and a work plan was developed to address the gaps identified. The first round of 4-week mentorships were conducted at each of the new sites. Additionally, all the four accredited laboratories maintained their statuses.

In 2016, CLSI technical assistance was further extended to two regional laboratories (Singida Regional Referral and Turiani Mission Hospital in Morogoro). To date, CLSI expert mentors have conducted two four-week mentorships at each of these laboratories. In the same year, Kilimanjaro Christian Medical Center and Mnazi Mmoja in Zanzibar achieved international accreditation bringing the number of accredited laboratories in Tanzania to six. By end of December 2016, four more laboratories (Temeke, Ndanda, Kibong’oto and Aga Khan) had applied for international accreditation. It is hope that these will attain accreditation by the end of 2017.

CLSI continues to provide capacity building and technical assistance to laboratories in Tanzania by working in collaboration with the CDC, CoAg Implementing Partners, and Ministry of Health, Community Development, Gender, Elderly &Children (MoHCDGE&C) to ensure sustainable strengthening of national laboratory systems, assist twelve specific laboratories in attaining or maintaining accreditation through mentorship, and assist MoHCDGE&C in developing policies that align with the internationally recognized laboratory standards for medical laboratories.

Ukraine

During the period from August 15-26, 2016, a CLSI Team consisting of two staff and one volunteer traveled to the Ukraine for an Initial Visit and conducted a series of laboratory assessments in both Kyiv and Odessa, Ukraine. The assessment tool used is the WHO Laboratory Assessment Tool published in April 2012. This tool is composed of two separate checklists: the System Questionnaire and the Facility Questionnaire. The System Questionnaire is intended for the health authorities in charge of diagnostic and public health laboratory management. It was utilized in the assessment of the Ukrainian Center for Disease Control of the Ministry of Health of Ukraine. The Facilities Questionnaire was used to assess the remaining laboratories (with the exception of the Trust Cabinet). Additional assessments were conducted by CLSI in December 2016.

The Ukraine has a three tiered (3 highest to 1 lowest) health care delivery system with many vertical and disease specific pillars. Recent missions have been conducted by multiple Partners to evaluate current testing capabilities, infrastructure needs, QMS implementation, and human and financial resources, with the goal of network reorganization to eliminate inefficiencies and redundancy and to form a truly networked health care delivery system.

QMS Workshops to target the Gaps identified by the assessments are planned for 2017.

Vietnam

Upon conclusion of the National Laboratory Strategic Plan project in 2009, CLSI and CDC-Vietnam began planning for the implementation of the master’s level certificate program Quality Management Systems for Laboratory Leaders (QMS-LL). This CLSI certificate program is designed for people working in leadership positions who have influence over the country or facility’s laboratory policy. The year-long curriculum focuses on the CLSI QMS model and related standards aimed at providing officials with the skills and tools necessary to improve laboratory efficiency and testing accuracy.

Between 2011 and 2016, CLSI delivered the QMS-LL curriculum to 3 cohorts of laboratory professionals, awarding 70 Certificates of Completion.
The third program was delivered in collaboration with the University of Medicine and Pharmacy (UMP) in Ho Chi Minh City. The goal of this partnership was to prepare faculty from UMP and Hanoi Medical University to deliver the CLSI QMS-LL curriculum. At the conclusion of the third program the curriculum was shared with UMP to integrate into their professional development and laboratory medicine Master’s programs. This approach was an exciting opportunity to ensure sustainability of the QMS-LL concept. CLSI programming continues in Vietnam with a continued focus on QMS training to laboratory staff, quality managers and laboratory directors.

Zambia

Since 2010, GHP’s QMS work in Zambia has been three fold:

  • To train current practicing laboratorians, quality officers, and managers to develop and implement Quality Management Systems in their laboratories, with the goal of accreditation preparedness.
  • To follow that training with in-laboratory QMS technical assistance in the form of quality mentors who provide guidance on QMS implementation in accordance with ISO international standards.
  • To develop a QMS course curriculum to be added to the university Biomedical Science program, designed to sensitize new laboratorians about quality prior to entering the workforce.

In 2017, GHP will continue to provide training and technical assistance and celebrate the progress that participating laboratories have made toward the implementation of Quality Management Systems.

 

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