Proceedings of a Workshop
Implementation of Good Laboratory Practices: A Joint Pakistan-U.S. Workshop
Proceedings of a Workshop—in Brief
On October 22-24, 2019, the U.S. National Academies of Sciences, Engineering, and Medicine (the National Academies) and the Pakistan Academy of Sciences (PAS) convened a workshop in Doha, Qatar on the campus of Georgetown University in Qatar. This workshop, which included some 30 attendees from Pakistan and the United States, built upon previous joint events on various aspects of human and animal clinical laboratories. The first such workshop was held at PAS in Islamabad, Pakistan, in 2016. In early 2019, PAS together with the Pakistani National Institutes of Health (NIH), published a Handbook on Good Clinical Laboratory Practices in Pakistan.1 It serves as an informational guide for clinical laboratories with the aim of improving the health and well-being of people, animals, and the environment in Pakistan.
The main goal of the 2019 workshop was to develop a plan for further implementation of the key concepts and practices outlined in the Handbook across the diverse landscape of Pakistani human and animal clinical labs.2 Specifically, this involved reviewing key areas for development and improvement in laboratories across Pakistan, identifying challenges to implementation, and analyzing practical steps that can be taken at the local, provincial, and national levels to overcome those challenges. Following a series of presentations at the workshop on current laboratory practices, policies, and challenges in Pakistan and other countries, coupled with breakout group discussions, participants developed a possible plan for implementation of the concepts in the Handbook. Participants in breakout groups spoke about human health laboratories, animal health laboratories, critical barriers as well as current and future needs of national support. They provided suggestions in each of these areas, and then presented their conclusions to the full group. This Proceedings in-Brief summarizes the presentations and discussions at the workshop. The plan for implementation developed by workshop participants, as well as key points from the workshop, appears at the conclusion of the document.
WORKSHOP OPENING SESSION
Workshop co-chairs Aamer Ikram, executive director of the National Institutes of Health in Pakistan, and Ali Khan, dean of the College of Public Health at the University of Nebraska Medical Center and retired U.S. assistant surgeon general, introduced the goals of the workshop and presented background information on the history of National Academies’—PAS collaborations. Ikram stated that the Handbook is based on the One Health3 concept, and while the Pakistani government has in the past focused on the medical and human clinical aspects of One Health, it is now expanding. Although there are many laboratory manuals, this handbook was created to address gaps in existing practice, including lab certification, accreditation, commissioning, safety, security, and dual-use issues. Ikram noted that
1 The idea for such a handbook developed during the 2016 workshop, and was subsequently written by Pakistani authors, in cooperation with U.S. experts. In 2018, Pakistani and U.S. experts met in Bangkok to discuss and revise the Handbook, released in English and Urdu. For the English version, see: https://www.nih.org.pk/handbook-on-good-clinical-laboratory-practices-in-pakistan-has-been-launched.
2 Hereafter referred to as “plan for implementation.”
3 The One Health concept recognizes the importance of the interrelationship between human health, animal health, and the environment. This workshop focused primarily on the human and animal health aspects, but participants acknowledged that this is an important organizing concept in its totality for Pakistan, and particularly for NIH.
workshop participants consisted of an amalgam of experts from different geographic areas of Pakistan, many of whom were young professionals. A participant noted that the group was comprised almost equally of men and women, and this gender parity was applauded.
Ikram expressed his wish that Pakistan would become the model for similarly resourced countries, and said that the NIH has also published its National Laboratory Policy. He said that he would like to form a group to facilitate the implementation of the policy. Participants discussed the ‘clinical’ component of the Handbook; many agreed with Ikram that Pakistan would benefit from the implementation of the concepts in the Handbook at other types of labs as well, including research labs.
Pakistani and U.S. participants provided background information to help frame issues and considerations before they broke into groups to work on the plan for implementation of the concepts contained in the Handbook. The primary issues addressed in the initial presentations were related to regulatory issues, laboratory goals, and laboratory effectiveness, namely:
- The regulatory systems in Pakistan are fragmented and inconsistently implemented.
- Laboratory accreditation in Pakistan remains voluntary.
- The NIH in Pakistan is the primary governmental agency responsible for developing public health laboratory networks. This network has been built upon the unifying concept of One Health, which encompasses human, animal, and environmental health.
- Real-time disease surveillance, as an essential function of clinical laboratories, requires effective animal health and human health data systems.
- Animal health clinical laboratories have an additional goal beyond animal health: supporting economic health with the secondary goal of supporting human health.
- A network of public and private sector laboratories across Pakistan is critical to increasing the effectiveness of labs and to decreasing disparities among them.
- Challenges to clinical laboratories include the quality of bench work results/data, and efficiency as measured by turnaround time.
- Efforts to increase laboratory effectiveness/efficiencies are enhanced by adhering to the following principles: (1) consider the end users and context, (2) keep scale and sustainability in mind, (3) be data-driven and evidence-based, (4) collaborate, and (5) be flexible and adaptable.
- Tailored biosecurity and biorisk management training for employees, including lab personnel and support staff (sanitary workers, managers, etc.), as well as external first responders can improve the safety and security at all types of laboratories, including clinical laboratories.
The breakout group on animal health laboratories highlighted the need to conduct awareness training through traditional methods, such as conferences and seminars, as well as through television interviews and social media. Breakout group participants also recommended establishing an organization dedicated to improving good laboratory practices (GLP) and providing country-wide training in GLP. The breakout group indicated that the end goal should be a unified One Health approach with a network to implement good clinical laboratory practices as well as a cohort of good laboratory practitioners.
The breakout group on human health laboratories identified a similar target audience as the animal health group, with the addition of residents in training and waste disposal personnel. The group indicated that in addition to the online Handbook (in Urdu and English), online training modules and reference documents should be developed and made accessible. They suggested that tiered standards need to be adopted by labs at all levels (district, provincial, and federal) after which trainers could administer accreditation. This could be implemented through a laboratory assessment tool. A long-term goal is to pass provincial level legislation related to human health clinical labs. In order to achieve these goals and implement these steps, it will be necessary to have the appropriate human resources, IT support, financing, training, and professional organizations (e.g., Population Association of Pakistan, Pakistan Biological Safety Association, Medical Microbiology and Infectious Disease Society of Pakistan). Ikram stated that it will take another 18 months for NIH to complete the quality standards needed to meet ISO accreditation requirements, which are relevant standards internationally. He added that NIH has been training lab personnel from both public and private laboratories, and will ensure that personnel have continuing education grants and opportunities. This practice, he said, helps facilitate lab licensing and registration to occur on a regular basis.
The breakout group on critical challenges highlighted the problems of unauthorized laboratories, unqualified staff, a lack of a proactive approach to addressing challenges, bribery in food and forensic laboratories, inappropriate management of biohazard materials, vested interests, and a lack of enforcement of regulations. Due to these challenges, participants said, opportunities and mechanisms for whistle-blowing, exploration and exposure of wrongdoing or neglect, and the means of participating in clean-up operations can be strengthened by already established policies of regulatory bodies, such as NIH and the provincial health agencies, and by providing education on the implications and repercussions of illegal practices. The group recommended short-term actions and activities including training on professionalism and dual-use ethical concerns in lab practices; establishment of a laboratory directory with addresses and accreditation information; compliance with accreditation standards/SOPs; and implementation of reference documents such as the Material Safety Data Sheet. In the medium- and long-term, the critical challenges breakout group recommended a public awareness campaign, national laboratory standards, and coursework on professionalism in higher education institutions.
The breakout group on national support and policies noted the need to involve the federal Ministry of National Health Services Regulation and Coordination (which includes NIH, the Pharmacy Council of Pakistan, the Drug Regulatory Authority of Pakistan, and the Pakistan Medical and Dental Council), Higher Education Commission, Pakistan Veterinary Medical Council, Pakistan Agricultural Research Council, and Provincial Health Departments. Participants noted the challenge of implementing licensing and accreditation standards for laboratories and stressed the need to set basic minimum standards. However, participants indicated that there are opportunities to establish/maintain such standards through the NIH, Pakistan National Accreditation Council, and Armed Forces Institute. In addition to the existing national laboratory policy and national laboratory biosafety and biosecurity policy, a National Infection Prevention and Control Guidelines and an Antimicrobial Resistance policy were being developed at the time of the workshop. In the short term, they recommended local-level dissemination of the Handbook involving awareness campaigns, a proactive approach to communication with provincial governing bodies, and meetings with key stakeholders. Such actions should, they said, also involve workshops and conferences, standard training modules, competency development for professionals, and development of curriculum and toolkits. The group recognized that the Handbook will need to be updated, and recommended a second edition 3 to 5 years after initial publication. The goal, they said, is for 75 percent of all laboratories in Pakistan to have received ISO-accreditation/certification or licensure within this timeframe. In order to set basic lab standards, incentives such as licensing and education are important. They added that a punitive approach is not effective in this context.
The workshop co-chairs, Ikram and Khan, led a session to conclude the workshop, incorporating the ideas of each of the breakout groups into a plan for implementation. This is outlined on the following page in Table 1.
TABLE 1 Plan for Implementation of the Handbook on Good Laboratory Practices in Pakistan
DISCLAIMER: The Proceedings of a Workshop—in Brief was prepared by Nicole Cervenka as a factual proceedings of what occurred at the meeting. The statements made are those of the author or individual meeting participants and do not necessarily represent the views of all meeting participants, the planning committee, or the National Academies of Sciences, Engineering, and Medicine.
REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop—in Brief was reviewed in draft form by Naila Siddique, Pakistan Agricultural Research Council; Tanzeel Zohra, National Institute of Health, Islamabad; and Fernando Torres-Velez, The Carter Center. The review comments and draft manuscript remain confidential to protect the integrity of the process.
PLANNING COMMITTEE: David Franz, independent consultant; Diane Griffin, Distinguished University Service Professor, W. Harry Feinstone Department of Molecular, Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health; Margaret Hamburg, Foreign Secretary, National Academy of Medicine; Ali Khan, co-chair, Dean, College of Public Health at the University of Nebraska Medical Center, ret. Assistant Surgeon General; and, Julie Pavlin, Senior Board Director, Board on Global Health, National Academies of Sciences, Engineering, and Medicine.
SPONSORS: This workshop was sponsored by the U.S. Department of State through an agreement between the National Academies of Sciences, Engineering, and Medicine, under contract number: S-ISNCT-17-CA-0037. The organizers would also like to thank Kai-Henrik Barth and Rana Saad and Georgetown University in Qatar for hosting the workshop at their facilities.
SUGGESTED CITATION: National Academies of Sciences, Engineering, and Medicine. 2020. Implementation of Good Laboratory Practices: A Joint Pakistan-U.S. Workshop—Proceedings of a Workshop-in Brief. Washington, DC: The National Academies Press. https://doi.org/10.17226/25967.
Policy and Global Affairs
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