Strengthening and Sustaining a Network of Public and Animal Health Clinical Laboratories in Pakistan Proceedings of a Joint Workshop (2023) / Chapter Skim
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3 Key Elements of Effective Clinical Labs and Laboratory Networks
3 Key Elements of Effective Clinical Labs and Laboratory Networks
Pages 25-42
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2 The Select Agent Program is run by the U.S. Department of Agriculture and the U.S.
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that mirrored a concept in nuclear safety and security. This concept is captured in the term biological "surety," which encompasses biological safety, physical security, agent accountability, and personnel reliability.6 It requires that persons with access to select agents be mentally alert, mentally and emotionally stable, trustworthy, and physically competent.7 Generally, the focus turned away from safety and more toward security in laboratories.
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Army lab unintentionally shipped virulent anthrax diagnostic specimens to other labs around the country and to a small number of labs outside of the United States. Gene-editing tech niques, such as C RISPR-Cas9, have also created a situation in which lead ing scientists suggested biosafety and biosecurity review before widespread use of the new technology.
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As Steven Covey noted, high-trust organizations have increased value, growth, innovation, collaboration, partnership, and execution. Low-trust organizations have redundancy, bureaucracy, politics, and disengagement.10 Leadership can decide and affect whether an organization becomes high trust or low trust.
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BUILDING THE NEXT GENERATION OF CLINICAL SCIENTISTS AND PRACTITIONERS IN PAKISTAN Zabta Shinwari addressed the issue of quality in building the next generation of clinical scientists and practitioners in Pakistan. He began by explaining that there is a mechanism in place at the Higher Education Commission (HEC)
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OVERVIEW OF PAKISTAN'S CLINICAL LABORATORY INFRASTRUCTURE: GEOGRAPHY, COVERAGE, CAPABILITIES, COMMUNICATIONS, AND CHALLENGES Aamer Ikram began by affirming that the government aims to strengthen Pakistan's health systems through leadership and governance related to service delivery, human resources, medicine and technologies, financing, and information.12 Clinical laboratories play a key role in the country's system of human and animal public health. They operate in the public sector at different levels, including at civilian hospitals, medical colleges, and military hospitals.
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Dedicated national institutes include the National Institute of Health, P akistan and the Armed Forces Institute of Pathology. The National Tuberculosis Control Program has 16 Biosafety Level-3 labs.15 Infrastructure Basic lab infrastructure is present in most hospitals and research institutes in Pakistan, said Ikram, although lab design and construction for most of these facilities are not consistent with international standards.
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There is also a lack of coordina tion between the human and veterinary public health sectors and a lack of tiered lab networks. In addition, there is a lack of integrated disease surveil lance programs backed by a network of public health laboratories.
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Quality Management Systems The Pakistan National Accreditation Council (PNAC) provides accreditation according to international standards.
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Overall, the biorisk management programs are deficient and there is no in-country verification capacity, Ikram warned. Communication and Information Systems A computerized laboratory information management system (LIMS)
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In closing, Ikram laid out a number of goals for the future. By 2025, Pakistan will have a well-recognized sustainable system of quality laboratory services under the One Health concept that are accessible and affordable to all with a laboratory system governed and monitored through regularly updated policies, plans, rules, and regulations.17 Laboratories in networks will use paperless information and documentation systems according to international standards, thus ensuring optimal patient care and robust surveillance of public health events.
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They include: • Quality management systems • Document control processes • Contracts, tenders, subcontracts, purchasing, and supplies • Lab referral processes • External services and supplies • Complaint resolution • Preventative and corrective actions • Customer service • Personnel processes, including qualifications, and continual training • Quality and maintenance; and calibration of equipment, reagents, and consumables • Sample control, labeling, and handling PNAC is responsible for ensuring that these standards are implemented in labs that voluntarily choose to undergo the accreditation process. In turn, the International Laboratory Accreditation Cooperation and International Accreditation Forum are responsible for ensuring the credibility of PNAC as the accreditation body, she said.
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CDC or the Association of Public Health Laboratories in the United States. Khawaja detailed the importance of creating competent laboratories.
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2015. Competency Guidelines for Public Health Laboratory Professionals.
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It encompasses numerous subdisciplines in areas of both organic and inorganic testing. Chemistry programs within public health laboratories provide a first line of defense in the rapid recognition of toxic chemical exposures, and also support environmental health and epidemiological programs that investigate human exposures to chemicals in the environment.
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The competencies he outlined should serve as a foundation for workforce development efforts to identify and support training standards, and performance evaluations for workers at PHLs. The successful acquisition and continued demonstration of these competencies in a well-trained PHL workforce requires ongoing leadership support.
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KEY ELEMENTS OF EFFECTIVE CLINICAL LABS AND LABORATORY NETWORKS 41 tional Health Regulations would aid in this effort. Ali Khan added that having a national lab system can help achieve the quality needed.
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