Assisting Laboratories in Countries Around the World
CLSI Partnerships staff and volunteers travel the globe to give laboratories the tools and training they need to succeed.
We are currently providing support programs to laboratories all over the world. While our Partnerships are always expanding support services to new areas, we have assisted in the areas below and are currently providing programs to laboratories listed below with asterisks:
Central Asia
Central Asia
CLSI’s technical assistance visits in Central Asia started in late 2010. In 2015, a total of 30 participants were trained as quality managers, representing both Kazakhstan and Kyrgyzstan. In 2016, our work expanded into Uzbekistan. A series of laboratory assessor trainings were conducted. In 2017, technical support for the implementation of quality management systems (QMS) and accreditation preparation was provided to the Republican AIDS Center and Institute of Virology. To meet an increased demand of antiretroviral treatment and viral load testing rapid scale-up, during 2018, CDC and CLSI organized a series of four “HIV Molecular Testing Methodology – PCR” training workshops for Central Asia laboratory specialists to support the strengthening of HIV viral load testing services in Central Asian countries. To consolidate successes achieved, by request of national counterparts, CLSI continued providing technical assistance to HIV viral load testing personnel by arranging subject matter experts through online consultations and on-site mentorship support to increase the knowledge and core competencies of laboratory staff performing HIV molecular testing in CAR countries.
Dominican Republic
Dominican Republic
The first CLSI/Centers for Disease Control and Prevention (CDC)-supported laboratory strengthening activities in the Western Hemisphere began in the Dominican Republic in 2016. Mentoring and training events were designed to support the CDC focus on improving the quality of viral load testing and HIV rapid testing. CLSI worked with the National Reference Laboratory (NRL) and five point-of-care laboratories throughout the country. CLSI established and maintained a local CLSI office in the Dominican Republic. Efforts to strengthen the NRL, expand viral load testing, and EQA program mentoring were undertaken. CLSI also supported the strengthening of HIV diagnostic services at selected laboratories and mobile sites. CLSI encouraged mentored sites to adhere to national reporting guidelines for HIV positive results by using the SINAVE System. From FY2017 to FY2018, there was an increase of 59% in reporting from prioritized sites mentored by CLSI. Between 2017–2018 a total of 49 new staff that performed HIV testing were trained during HIV RTQ workshops. The Ministry of Public Health assumed the RTQII-HIV training package for the certification of personnel who performed HIV tests. Those efforts led to an increase in the correctly filled out records for viral load and rapid HIV testing.
Ethiopia
Ethiopia
CLSI began work in Ethiopia in 2014. Adama laboratory had two departments accredited in 2015 after three one-month CLSI mentorships. 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 aligned with ISO 15189. The Adama team traveled to Dar es Salaam, Tanzania, to visit the National Health Laboratory Quality Assurance and Training Center (NHLQATC) on an experience sharing tour. The NHLQATC was the first CLSI-supported laboratory in Tanzania to achieve international accreditation aligned with ISO 15189. Following this trip, and four one-month visits, the Ahmara laboratory was accredited to a full scope in October 2018. In 2017, the Ethiopian Public Health Institute was mentored on ISO 17043. CLSI helped with all documentation required for the system. In 2018, Tigray and Hawassa both received two two-week mentorships by CLSI.
Ghana
Ghana
CLSI received President's Emergency Plan for AIDS Relief (PEPFAR) funding for work in Ghana beginning in 2010. CLSI’s programming targeted building capacity of the laboratory leadership in Ghana, focusing on a systems approach to quality in laboratory medicine, supporting the development and implementation of appropriate policies for laboratory operations at all levels throughout the health care system.
India
India
CLSI’s Partnerships returned to South Asia in 2016, conducting laboratory strengthening activities in India. Programming supported the WHO/CDC focus on improving the quality of viral load testing and HIV rapid testing.
Kazakhstan
Kazakhstan
In 2014, Kazakhstan's Ministry of Healthcare and Social Development of Kazakhstan worked with the Centers for Disease Control and Prevention (CDC) Foundation to launch the Field Epidemiology and Laboratory Training Program (FELTP). With the goal of establishing a network of modern labs that follow international laboratory standards and provide reliable and trustworthy results, the program focused on training laboratory managers how to implement a quality management system for their own facilities, while serving as mentors for improvement efforts at other laboratories.
Kenya
Kenya
In 2014, two CLSI mentors traveled to Kenya to conduct assessments in 6 laboratories across the country. The assessments were intended to evaluate the general implementation of the quality management system in each of the laboratories and to provide strategies for laboratories to implement in preparation for accreditation. With the support of CDC-Kenya, gaps identified in these assessments led the way for implementation of laboratory strengthening activities in Kenya. With the unwavering commitment of four local mentors, CLSI worked together with 12 designated laboratories to strengthen their QMS through mentorships and trainings. CLSI also supported blood safety initiatives through assessments of eight blood transfusion units and the development of the National Injection Safety Policy document. To ensure a sustainable program, CLSI made strides in building local capacity by training Kenyan laboratorians with basic mentoring and assessing skills.
Successes of the Program:
-
12 laboratories mentored by CLSI reached ISO 15189 accreditation through Kenya Accreditation Service (KENAS).
-
300+ laboratory professionals in Kenya successfully completed CLSI training modules that enabled them to effectively interpret and implement QMS as required by ISO 15189 standards.
Read the Kenya Case Study Watch the Kenya Video
Mozambique
Mozambique
CLSI programming in Mozambique provided support to the Ministry of Health to develop, review, and revise key laboratory policy documents, ensuring compliance with international recommendations and standards.
Namibia
Namibia
In 2014, CLSI, through its Global Health Partnerships (GHP) and in collaboration with the US Centers for Disease Control and Prevention (CDC), supported laboratory strengthening activities within the National Institute of Pathology (NIP) in Namibia. This technical support focused mainly on strengthening laboratories implementing quality management systems (QMS) to improve the quality of operations for the benefit of patients. The overarching strategies employed included:
- Providing mentorship to selected laboratories to develop a QMS and work towards attainment and maintenance of ISO 15189 and ISO 17025 aligned accreditation.
- Building QMS capacity to identified laboratorians in Namibia through focused trainings to advance knowledge, skills, and practice.
- Developing a cadre of quality mentors and assessors to sustain the program long after PEPFAR support.
Successes of the Program:
- Seven laboratories were assisted in achieving and maintaining international accreditation within the NIP network of laboratories.
- Ten plus QMS workshops were conducted, training 300+ laboratory professionals in different QMS topics.
- CLSI subject matter experts spent upwards of 3,000 hours working side-by-side with local laboratory professionals to mentor them in implementing QMS and best practices.
- Thousands of patients benefited from QMS implementation by receiving accurate and timely laboratory test results, which helped doctors make better medical decisions for their patients.
People’s Republic of China (PRC)
People’s Republic of China (PRC)
CLSI has a continuing role in supporting the PRC's steady improvement of the quality and capabilities of its medical laboratory infrastructure. The CLSI/PRC relationship aligns with CLSI’s nonprofit mission to develop clinical and laboratory practices and promote their use worldwide.
Tanzania*
Tanzania*
For over fifteen years, through the PEPFAR and GHSA programs, CLSI has collaborated with CDC Tanzania and other partners to support the goals of the Ministry of Health, Community Development, Gender, Elderly and Children in Tanzania (MOHCDGEC) to ensure sustainable strengthening of the national laboratory system.
The technical assistance has been delivered in the form of training through centralized and localized workshops, mentorships, and rapid assessments. Over 1,000 laboratory professionals have been trained in Quality Management System (QMS) workshops facilitated by CLSI. Most recently, the workshops have been focused on specific QMS topics such as internal audit, root cause analysis and corrective action, and quality control and method verification.
Over the past few years, Tanzania’s laboratory strengthening program has been experiencing progressive and exponential growth. With the goal of making the program sustainable, there has been a shift toward building in-country capacity so that there are more local mentors to assist laboratories with QMS implementation. Using a mentor fundamentals course series developed by CLSI, which equips laboratorians with mentoring skills, CLSI and partner, MDH, have been building a pool of QMS experts that can assist the MOHCDGEC in scaling up laboratory strengthening activities in the country. Today, the Ministry’s Laboratory Services Unit in partnership with MDH leads the initiative, while CLSI’s GHP supports with technical assistance. Currently, there are 40+ local mentors from labs that have been accredited who have been trained through this partnership. Working together, the CLSI mentors and the Tanzanian mentors have been supporting the laboratories that have been implementing SLMTA and those that are preparing for accreditation.
Before 2014, Tanzania had no accredited labs. In 2014, three achieved accreditation. Over the next four years, CLSI mentored five more labs in their pursuit of accreditation. Tanzania now has over 40 laboratories that have gone through the CLSI mentorship model and achieved international accreditation. More than 25 additional laboratories are implementing QMS with the support of Tanzanian and CLSI mentors in pursuit of accreditation.
Ukraine
Ukraine
Missions in Ukraine were conducted by CLSI and multiple partner organizations to evaluate testing capabilities, infrastructure needs, QMS implementation, and human and financial resources. QMS workshops to target the gaps identified by the assessments were planned for 2017.
Vietnam
Vietnam
CLSI programming in Vietnam focused on QMS training to laboratory staff, quality managers, and laboratory directors. In November 2018, a CLSI team traveled to Hanoi, Vietnam, and conducted a four‑day workshop on quality control, method evaluation, verification of HIV rapid testing, and ELISA testing.
Zambia*
Zambia*
With the support of the Ministry of Health Zambia and the US Centers for Disease Control and Prevention (CDC), CLSI, through its Global Health Partnerships (GHP) has been supporting laboratory strengthening activities in Zambia since 2010. More recently, in conjunction with Centre for Infectious Disease Research in Zambia-Lab Innovation for Excellence (CIDRZ LIFE) project, quality management system (QMS) activities have expanded to reach more laboratories.
Zimbabwe*
Zimbabwe*
Since 2021, through partnership with the Biomedical Research and Training Institute (BRTI) and the US Centers for Disease Control and Prevention (CDC), CLSI has been assisting with quality management systems (QMS) implementation, continual quality improvement (CQI) initiatives, and laboratory systems strengthening (LSS) efforts across Zimbabwe for testing laboratories, specimen referral hubs, and HIV point-of-care testing (POCT) clinics.
With support from the Ministry of Health and Child Care Zimbabwe (MOHCCZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCSCZ) and other key stakeholders, CLSI’s Global Health Partnerships (GHP) and our local team continue to strengthen local capacity, build sustainable systems, and improve the quality of testing in Zimbabwe.
Central Asia
Dominican Republic
Ethiopia
Central Asia
CLSI’s technical assistance visits in Central Asia started in late 2010. In 2015, a total of 30 participants were trained as quality managers, representing both Kazakhstan and Kyrgyzstan. In 2016, our work expanded into Uzbekistan. A series of laboratory assessor trainings were conducted. In 2017, technical support for the implementation of quality management systems (QMS) and accreditation preparation was provided to the Republican AIDS Center and Institute of Virology. To meet an increased demand of antiretroviral treatment and viral load testing rapid scale-up, during 2018, CDC and CLSI organized a series of four “HIV Molecular Testing Methodology – PCR” training workshops for Central Asia laboratory specialists to support the strengthening of HIV viral load testing services in Central Asian countries. To consolidate successes achieved, by request of national counterparts, CLSI continued providing technical assistance to HIV viral load testing personnel by arranging subject matter experts through online consultations and on-site mentorship support to increase the knowledge and core competencies of laboratory staff performing HIV molecular testing in CAR countries.
Dominican Republic
The first CLSI/Centers for Disease Control and Prevention (CDC)-supported laboratory strengthening activities in the Western Hemisphere began in the Dominican Republic in 2016. Mentoring and training events were designed to support the CDC focus on improving the quality of viral load testing and HIV rapid testing. CLSI worked with the National Reference Laboratory (NRL) and five point-of-care laboratories throughout the country. CLSI established and maintained a local CLSI office in the Dominican Republic. Efforts to strengthen the NRL, expand viral load testing, and EQA program mentoring were undertaken. CLSI also supported the strengthening of HIV diagnostic services at selected laboratories and mobile sites. CLSI encouraged mentored sites to adhere to national reporting guidelines for HIV positive results by using the SINAVE System. From FY2017 to FY2018, there was an increase of 59% in reporting from prioritized sites mentored by CLSI. Between 2017–2018 a total of 49 new staff that performed HIV testing were trained during HIV RTQ workshops. The Ministry of Public Health assumed the RTQII-HIV training package for the certification of personnel who performed HIV tests. Those efforts led to an increase in the correctly filled out records for viral load and rapid HIV testing.
Ethiopia
CLSI began work in Ethiopia in 2014. Adama laboratory had two departments accredited in 2015 after three one-month CLSI mentorships. 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 aligned with ISO 15189. The Adama team traveled to Dar es Salaam, Tanzania, to visit the National Health Laboratory Quality Assurance and Training Center (NHLQATC) on an experience sharing tour. The NHLQATC was the first CLSI-supported laboratory in Tanzania to achieve international accreditation aligned with ISO 15189. Following this trip, and four one-month visits, the Ahmara laboratory was accredited to a full scope in October 2018. In 2017, the Ethiopian Public Health Institute was mentored on ISO 17043. CLSI helped with all documentation required for the system. In 2018, Tigray and Hawassa both received two two-week mentorships by CLSI.
Ghana
India
Kazakhstan
Ghana
CLSI received President's Emergency Plan for AIDS Relief (PEPFAR) funding for work in Ghana beginning in 2010. CLSI’s programming targeted building capacity of the laboratory leadership in Ghana, focusing on a systems approach to quality in laboratory medicine, supporting the development and implementation of appropriate policies for laboratory operations at all levels throughout the health care system.
India
CLSI’s Partnerships returned to South Asia in 2016, conducting laboratory strengthening activities in India. Programming supported the WHO/CDC focus on improving the quality of viral load testing and HIV rapid testing.
Kazakhstan
In 2014, Kazakhstan's Ministry of Healthcare and Social Development of Kazakhstan worked with the Centers for Disease Control and Prevention (CDC) Foundation to launch the Field Epidemiology and Laboratory Training Program (FELTP). With the goal of establishing a network of modern labs that follow international laboratory standards and provide reliable and trustworthy results, the program focused on training laboratory managers how to implement a quality management system for their own facilities, while serving as mentors for improvement efforts at other laboratories.
Kenya
Mozambique
Namibia
Kenya
In 2014, two CLSI mentors traveled to Kenya to conduct assessments in 6 laboratories across the country. The assessments were intended to evaluate the general implementation of the quality management system in each of the laboratories and to provide strategies for laboratories to implement in preparation for accreditation. With the support of CDC-Kenya, gaps identified in these assessments led the way for implementation of laboratory strengthening activities in Kenya. With the unwavering commitment of four local mentors, CLSI worked together with 12 designated laboratories to strengthen their QMS through mentorships and trainings. CLSI also supported blood safety initiatives through assessments of eight blood transfusion units and the development of the National Injection Safety Policy document. To ensure a sustainable program, CLSI made strides in building local capacity by training Kenyan laboratorians with basic mentoring and assessing skills.
Successes of the Program:
-
12 laboratories mentored by CLSI reached ISO 15189 accreditation through Kenya Accreditation Service (KENAS).
-
300+ laboratory professionals in Kenya successfully completed CLSI training modules that enabled them to effectively interpret and implement QMS as required by ISO 15189 standards.
Read the Kenya Case Study Watch the Kenya Video
Mozambique
CLSI programming in Mozambique provided support to the Ministry of Health to develop, review, and revise key laboratory policy documents, ensuring compliance with international recommendations and standards.
Namibia
In 2014, CLSI, through its Global Health Partnerships (GHP) and in collaboration with the US Centers for Disease Control and Prevention (CDC), supported laboratory strengthening activities within the National Institute of Pathology (NIP) in Namibia. This technical support focused mainly on strengthening laboratories implementing quality management systems (QMS) to improve the quality of operations for the benefit of patients. The overarching strategies employed included:
- Providing mentorship to selected laboratories to develop a QMS and work towards attainment and maintenance of ISO 15189 and ISO 17025 aligned accreditation.
- Building QMS capacity to identified laboratorians in Namibia through focused trainings to advance knowledge, skills, and practice.
- Developing a cadre of quality mentors and assessors to sustain the program long after PEPFAR support.
Successes of the Program:
- Seven laboratories were assisted in achieving and maintaining international accreditation within the NIP network of laboratories.
- Ten plus QMS workshops were conducted, training 300+ laboratory professionals in different QMS topics.
- CLSI subject matter experts spent upwards of 3,000 hours working side-by-side with local laboratory professionals to mentor them in implementing QMS and best practices.
- Thousands of patients benefited from QMS implementation by receiving accurate and timely laboratory test results, which helped doctors make better medical decisions for their patients.
People’s Republic of China (PRC)
Tanzania*
Ukraine
People’s Republic of China (PRC)
CLSI has a continuing role in supporting the PRC's steady improvement of the quality and capabilities of its medical laboratory infrastructure. The CLSI/PRC relationship aligns with CLSI’s nonprofit mission to develop clinical and laboratory practices and promote their use worldwide.
Tanzania*
For over fifteen years, through the PEPFAR and GHSA programs, CLSI has collaborated with CDC Tanzania and other partners to support the goals of the Ministry of Health, Community Development, Gender, Elderly and Children in Tanzania (MOHCDGEC) to ensure sustainable strengthening of the national laboratory system.
The technical assistance has been delivered in the form of training through centralized and localized workshops, mentorships, and rapid assessments. Over 1,000 laboratory professionals have been trained in Quality Management System (QMS) workshops facilitated by CLSI. Most recently, the workshops have been focused on specific QMS topics such as internal audit, root cause analysis and corrective action, and quality control and method verification.
Over the past few years, Tanzania’s laboratory strengthening program has been experiencing progressive and exponential growth. With the goal of making the program sustainable, there has been a shift toward building in-country capacity so that there are more local mentors to assist laboratories with QMS implementation. Using a mentor fundamentals course series developed by CLSI, which equips laboratorians with mentoring skills, CLSI and partner, MDH, have been building a pool of QMS experts that can assist the MOHCDGEC in scaling up laboratory strengthening activities in the country. Today, the Ministry’s Laboratory Services Unit in partnership with MDH leads the initiative, while CLSI’s GHP supports with technical assistance. Currently, there are 40+ local mentors from labs that have been accredited who have been trained through this partnership. Working together, the CLSI mentors and the Tanzanian mentors have been supporting the laboratories that have been implementing SLMTA and those that are preparing for accreditation.
Before 2014, Tanzania had no accredited labs. In 2014, three achieved accreditation. Over the next four years, CLSI mentored five more labs in their pursuit of accreditation. Tanzania now has over 40 laboratories that have gone through the CLSI mentorship model and achieved international accreditation. More than 25 additional laboratories are implementing QMS with the support of Tanzanian and CLSI mentors in pursuit of accreditation.
Ukraine
Missions in Ukraine were conducted by CLSI and multiple partner organizations to evaluate testing capabilities, infrastructure needs, QMS implementation, and human and financial resources. QMS workshops to target the gaps identified by the assessments were planned for 2017.
Vietnam
Zambia*
Zimbabwe*
Vietnam
CLSI programming in Vietnam focused on QMS training to laboratory staff, quality managers, and laboratory directors. In November 2018, a CLSI team traveled to Hanoi, Vietnam, and conducted a four‑day workshop on quality control, method evaluation, verification of HIV rapid testing, and ELISA testing.
Zambia*
With the support of the Ministry of Health Zambia and the US Centers for Disease Control and Prevention (CDC), CLSI, through its Global Health Partnerships (GHP) has been supporting laboratory strengthening activities in Zambia since 2010. More recently, in conjunction with Centre for Infectious Disease Research in Zambia-Lab Innovation for Excellence (CIDRZ LIFE) project, quality management system (QMS) activities have expanded to reach more laboratories.
Zimbabwe*
Since 2021, through partnership with the Biomedical Research and Training Institute (BRTI) and the US Centers for Disease Control and Prevention (CDC), CLSI has been assisting with quality management systems (QMS) implementation, continual quality improvement (CQI) initiatives, and laboratory systems strengthening (LSS) efforts across Zimbabwe for testing laboratories, specimen referral hubs, and HIV point-of-care testing (POCT) clinics.
With support from the Ministry of Health and Child Care Zimbabwe (MOHCCZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCSCZ) and other key stakeholders, CLSI’s Global Health Partnerships (GHP) and our local team continue to strengthen local capacity, build sustainable systems, and improve the quality of testing in Zimbabwe.
Central Asia
Dominican Republic
Ethiopia
Ghana
Central Asia
CLSI’s technical assistance visits in Central Asia started in late 2010. In 2015, a total of 30 participants were trained as quality managers, representing both Kazakhstan and Kyrgyzstan. In 2016, our work expanded into Uzbekistan. A series of laboratory assessor trainings were conducted. In 2017, technical support for the implementation of quality management systems (QMS) and accreditation preparation was provided to the Republican AIDS Center and Institute of Virology. To meet an increased demand of antiretroviral treatment and viral load testing rapid scale-up, during 2018, CDC and CLSI organized a series of four “HIV Molecular Testing Methodology – PCR” training workshops for Central Asia laboratory specialists to support the strengthening of HIV viral load testing services in Central Asian countries. To consolidate successes achieved, by request of national counterparts, CLSI continued providing technical assistance to HIV viral load testing personnel by arranging subject matter experts through online consultations and on-site mentorship support to increase the knowledge and core competencies of laboratory staff performing HIV molecular testing in CAR countries.
Dominican Republic
The first CLSI/Centers for Disease Control and Prevention (CDC)-supported laboratory strengthening activities in the Western Hemisphere began in the Dominican Republic in 2016. Mentoring and training events were designed to support the CDC focus on improving the quality of viral load testing and HIV rapid testing. CLSI worked with the National Reference Laboratory (NRL) and five point-of-care laboratories throughout the country. CLSI established and maintained a local CLSI office in the Dominican Republic. Efforts to strengthen the NRL, expand viral load testing, and EQA program mentoring were undertaken. CLSI also supported the strengthening of HIV diagnostic services at selected laboratories and mobile sites. CLSI encouraged mentored sites to adhere to national reporting guidelines for HIV positive results by using the SINAVE System. From FY2017 to FY2018, there was an increase of 59% in reporting from prioritized sites mentored by CLSI. Between 2017–2018 a total of 49 new staff that performed HIV testing were trained during HIV RTQ workshops. The Ministry of Public Health assumed the RTQII-HIV training package for the certification of personnel who performed HIV tests. Those efforts led to an increase in the correctly filled out records for viral load and rapid HIV testing.
Ethiopia
CLSI began work in Ethiopia in 2014. Adama laboratory had two departments accredited in 2015 after three one-month CLSI mentorships. 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 aligned with ISO 15189. The Adama team traveled to Dar es Salaam, Tanzania, to visit the National Health Laboratory Quality Assurance and Training Center (NHLQATC) on an experience sharing tour. The NHLQATC was the first CLSI-supported laboratory in Tanzania to achieve international accreditation aligned with ISO 15189. Following this trip, and four one-month visits, the Ahmara laboratory was accredited to a full scope in October 2018. In 2017, the Ethiopian Public Health Institute was mentored on ISO 17043. CLSI helped with all documentation required for the system. In 2018, Tigray and Hawassa both received two two-week mentorships by CLSI.
Ghana
CLSI received President's Emergency Plan for AIDS Relief (PEPFAR) funding for work in Ghana beginning in 2010. CLSI’s programming targeted building capacity of the laboratory leadership in Ghana, focusing on a systems approach to quality in laboratory medicine, supporting the development and implementation of appropriate policies for laboratory operations at all levels throughout the health care system.
India
Kazakhstan
Kenya
Mozambique
India
CLSI’s Partnerships returned to South Asia in 2016, conducting laboratory strengthening activities in India. Programming supported the WHO/CDC focus on improving the quality of viral load testing and HIV rapid testing.
Kazakhstan
In 2014, Kazakhstan's Ministry of Healthcare and Social Development of Kazakhstan worked with the Centers for Disease Control and Prevention (CDC) Foundation to launch the Field Epidemiology and Laboratory Training Program (FELTP). With the goal of establishing a network of modern labs that follow international laboratory standards and provide reliable and trustworthy results, the program focused on training laboratory managers how to implement a quality management system for their own facilities, while serving as mentors for improvement efforts at other laboratories.
Kenya
In 2014, two CLSI mentors traveled to Kenya to conduct assessments in 6 laboratories across the country. The assessments were intended to evaluate the general implementation of the quality management system in each of the laboratories and to provide strategies for laboratories to implement in preparation for accreditation. With the support of CDC-Kenya, gaps identified in these assessments led the way for implementation of laboratory strengthening activities in Kenya. With the unwavering commitment of four local mentors, CLSI worked together with 12 designated laboratories to strengthen their QMS through mentorships and trainings. CLSI also supported blood safety initiatives through assessments of eight blood transfusion units and the development of the National Injection Safety Policy document. To ensure a sustainable program, CLSI made strides in building local capacity by training Kenyan laboratorians with basic mentoring and assessing skills.
Successes of the Program:
-
12 laboratories mentored by CLSI reached ISO 15189 accreditation through Kenya Accreditation Service (KENAS).
-
300+ laboratory professionals in Kenya successfully completed CLSI training modules that enabled them to effectively interpret and implement QMS as required by ISO 15189 standards.
Read the Kenya Case Study Watch the Kenya Video
Mozambique
CLSI programming in Mozambique provided support to the Ministry of Health to develop, review, and revise key laboratory policy documents, ensuring compliance with international recommendations and standards.
Namibia
People’s Republic of China (PRC)
Tanzania*
Ukraine
Namibia
In 2014, CLSI, through its Global Health Partnerships (GHP) and in collaboration with the US Centers for Disease Control and Prevention (CDC), supported laboratory strengthening activities within the National Institute of Pathology (NIP) in Namibia. This technical support focused mainly on strengthening laboratories implementing quality management systems (QMS) to improve the quality of operations for the benefit of patients. The overarching strategies employed included:
- Providing mentorship to selected laboratories to develop a QMS and work towards attainment and maintenance of ISO 15189 and ISO 17025 aligned accreditation.
- Building QMS capacity to identified laboratorians in Namibia through focused trainings to advance knowledge, skills, and practice.
- Developing a cadre of quality mentors and assessors to sustain the program long after PEPFAR support.
Successes of the Program:
- Seven laboratories were assisted in achieving and maintaining international accreditation within the NIP network of laboratories.
- Ten plus QMS workshops were conducted, training 300+ laboratory professionals in different QMS topics.
- CLSI subject matter experts spent upwards of 3,000 hours working side-by-side with local laboratory professionals to mentor them in implementing QMS and best practices.
- Thousands of patients benefited from QMS implementation by receiving accurate and timely laboratory test results, which helped doctors make better medical decisions for their patients.
People’s Republic of China (PRC)
CLSI has a continuing role in supporting the PRC's steady improvement of the quality and capabilities of its medical laboratory infrastructure. The CLSI/PRC relationship aligns with CLSI’s nonprofit mission to develop clinical and laboratory practices and promote their use worldwide.
Tanzania*
For over fifteen years, through the PEPFAR and GHSA programs, CLSI has collaborated with CDC Tanzania and other partners to support the goals of the Ministry of Health, Community Development, Gender, Elderly and Children in Tanzania (MOHCDGEC) to ensure sustainable strengthening of the national laboratory system.
The technical assistance has been delivered in the form of training through centralized and localized workshops, mentorships, and rapid assessments. Over 1,000 laboratory professionals have been trained in Quality Management System (QMS) workshops facilitated by CLSI. Most recently, the workshops have been focused on specific QMS topics such as internal audit, root cause analysis and corrective action, and quality control and method verification.
Over the past few years, Tanzania’s laboratory strengthening program has been experiencing progressive and exponential growth. With the goal of making the program sustainable, there has been a shift toward building in-country capacity so that there are more local mentors to assist laboratories with QMS implementation. Using a mentor fundamentals course series developed by CLSI, which equips laboratorians with mentoring skills, CLSI and partner, MDH, have been building a pool of QMS experts that can assist the MOHCDGEC in scaling up laboratory strengthening activities in the country. Today, the Ministry’s Laboratory Services Unit in partnership with MDH leads the initiative, while CLSI’s GHP supports with technical assistance. Currently, there are 40+ local mentors from labs that have been accredited who have been trained through this partnership. Working together, the CLSI mentors and the Tanzanian mentors have been supporting the laboratories that have been implementing SLMTA and those that are preparing for accreditation.
Before 2014, Tanzania had no accredited labs. In 2014, three achieved accreditation. Over the next four years, CLSI mentored five more labs in their pursuit of accreditation. Tanzania now has over 40 laboratories that have gone through the CLSI mentorship model and achieved international accreditation. More than 25 additional laboratories are implementing QMS with the support of Tanzanian and CLSI mentors in pursuit of accreditation.
Ukraine
Missions in Ukraine were conducted by CLSI and multiple partner organizations to evaluate testing capabilities, infrastructure needs, QMS implementation, and human and financial resources. QMS workshops to target the gaps identified by the assessments were planned for 2017.
Vietnam
Zambia*
Zimbabwe*
Vietnam
CLSI programming in Vietnam focused on QMS training to laboratory staff, quality managers, and laboratory directors. In November 2018, a CLSI team traveled to Hanoi, Vietnam, and conducted a four‑day workshop on quality control, method evaluation, verification of HIV rapid testing, and ELISA testing.
Zambia*
With the support of the Ministry of Health Zambia and the US Centers for Disease Control and Prevention (CDC), CLSI, through its Global Health Partnerships (GHP) has been supporting laboratory strengthening activities in Zambia since 2010. More recently, in conjunction with Centre for Infectious Disease Research in Zambia-Lab Innovation for Excellence (CIDRZ LIFE) project, quality management system (QMS) activities have expanded to reach more laboratories.
Zimbabwe*
Since 2021, through partnership with the Biomedical Research and Training Institute (BRTI) and the US Centers for Disease Control and Prevention (CDC), CLSI has been assisting with quality management systems (QMS) implementation, continual quality improvement (CQI) initiatives, and laboratory systems strengthening (LSS) efforts across Zimbabwe for testing laboratories, specimen referral hubs, and HIV point-of-care testing (POCT) clinics.
With support from the Ministry of Health and Child Care Zimbabwe (MOHCCZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCSCZ) and other key stakeholders, CLSI’s Global Health Partnerships (GHP) and our local team continue to strengthen local capacity, build sustainable systems, and improve the quality of testing in Zimbabwe.