3

Key Elements of Effective Clinical Labs and Laboratory Networks

LEADERSHIP IN A CHANGING WORLD

David Franz opened his presentation by stating that before 2001, a large concern of laboratory leaders was biosafety, keeping lab staff and the public safe from the agents in the lab. The publication Biosafety in Microbiological and Biomedical Laboratories, first published in 1984, was the key guide to ensuring safe and secure research in infectious disease labs.¹ However, in 1996, an American was caught by the U.S. Federal Bureau of Investigations (FBI) trying to obtain a sample of Yersinia pestis, a plague bacillus. At the time, no laws forbade this action, and he received no prison time, but instead served 200 hours of community service as punishment. His actions shifted the focus to ensuring good biosecurity at laboratories. The U.S. Select Agent rule was a result of this action.²

The 2001 terrorist attacks on the United States, as well as incidents in which anthrax powder was sent through the U.S. Postal Service, ushered in an era of increased spending on biodefense in the United States. The biodefense budget increased from $294 million for FY2001 to $5.2 billion

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¹ For a copy of the Fifth Edition of the publication, see https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2009-P.PDF.

² The Select Agent Program is run by the U.S. Department of Agriculture and the U.S. Centers for Disease Control and Prevention. For more information, see https://www.selectagents.gov.

in FY2004.³ Many more scientists were working with select agents, and new labs were constructed. The National Academies of Sciences, Engineering, and Medicine issued the report Biotechnology Research in an Age ofTerrorism,⁴ which detailed the “dual use dilemma” in the life sciences. The report stated that more good than harm will come from biotechnology, and we need those technologies for health and other useful purposes, but we must also balance regulations with progress in international and domestic scientific landscapes. The National Academies committee that authored the report recommended increased education and awareness, and not necessarily more regulation. The security and scientific communities needed to increase communications, and in the United States, the National Science Advisory Board for Biosecurity (NSABB) was created. One of the first tasks of the NSABB was to recommend whether or not the sequence of the 1918 flu should be published. NSABB recommended that it should be published so that the best scientists could work on healthcare solutions, explained Franz.

In 2008, the FBI concluded that scientist Bruce Ivins was responsible for the 2001 anthrax mailings, and suspicion grew that other scientists had the potential to do something similar, as captured in the World at Risk Report, which was produced by the Commission on the Prevention of WMD [Weapons of Mass Destruction] Proliferation and Terrorism.⁵ The report concluded something that Franz found painful: the United States should be more concerned that scientists would become terrorists than terrorists would become scientists. The United States began to view its scientists with suspicion. The U.S. Department of Defense responded with a new regulation (50-1) 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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³ The White House. 2004. HHS Fact Sheet: Biodefense Preparedness. https://georgewbush-whitehouse.archives.gov/news/releases/2004/04/20040428-4.html.

⁴ See National Research Council. 2004. Biotechnology Research in an Age of Terrorism. https://www.nap.edu/catalog/10827/biotechnology-research-in-an-age-of-terrorism.

⁵ For a copy, see http://www.npolicy.org/article.php?aid=241.

⁶ U.S. Department of Defense. 2008. Nuclear and Chemical Weapons and Material: Biological Surety. Army Regulation 50-1. https://fas.org/programs/bio/resource/documents/biological_surety_08.pdf.

⁷ Ibid, p.8.

Several other incidents received attention, outlined Franz. The U.S. National Institutes of Health funded grants to scientists to study H5N1, a zoonotic strain of highly pathogenic avian influenza, and make it transmissible through mammals.⁸ Although the grants were reviewed and approved by the NSABB, one of the researchers wanted to publish an article that focused on the “gain-of-function” concept that attracted a great deal of attention and generated a great deal of controversy initially. This gain of function concept refers to research that changes the way a virus works in nature, and new regulations for using these techniques were adopted as a result of the article. The pendulum started swinging back toward safety, away from security, in the context of these negotiations and deliberations.

Two safety lapses occurred at the U.S. Centers for Disease Control and Prevention (CDC) in 2014; one involved Anthrax exposures and another involved the shipment of a sample contaminated with non-inactivated H5N1 to a U.S. Department of Agriculture poultry lab in Georgia. Although no one was hurt in either incident, both were covered in the media. This caused the White House to intervene and initiate a pause in research on influenza, Middle East Respiratory Syndrome, and Severe Acute Respiratory Syndrome, and on corona viruses, which slowed many of the efforts toward vaccine development and other work. Leaders took responsibility for an organizational culture in which these lapses occurred and were not immediately reported up the organizational chain of command. Around this time, it was discovered that a U.S. 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 techniques, such as CRISPR-Cas9, have also created a situation in which leading scientists suggested biosafety and biosecurity review before widespread use of the new technology. It was discovered that Chinese regulation allowed scientists to use this technology on human embryos for up to 15 days. These incidents led to an evolution in the conversation on lab competence and community safety.

When unsafe or unsecure incidents occur, regulations are put in place as a result, which leads to hyper regulation of research rather than examination of cultures of safety and security of organizations themselves. This regulatory approach has affected how scientists have interacted with their international colleagues at times, and it has negatively affected U.S. labs.

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⁸ For more information, see http://www.nih.gov/about-nih/who-we-are/nih-director/statements/nih-statement-h5n1.

Regulations are important, but improving culture and organizations must receive more attention, argued Franz. Very few people commit a misdeed, but the response to the misdeed affects everyone. A great deal of research can be hurt or stalled when an unsafe or unsecure incident occurs. If a balance between research and regulation is not found, the biotech or science enterprise is harmed. Government regulations and oversight are necessary, but not sufficient. A few examples led Franz to this conclusion. In a study by Kendall Oyt about vaccine development, she found that the United States developed more vaccines in the post-World War II period more quickly than in recent years, even though technology is more developed today.⁹ She concluded that successful vaccines need a person to take the antigen or candidate and push it through the bureaucracy associated with development and translation as its champion. This requires high-trust organizations. 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. Leading with science, quality, safety, vigilance, education, responsibility, and transparency can create a culture of trust in an organization. Conversely, leading with security can create a culture of mistrust. Enlightened leadership can create a culture of trust in laboratories where dual-use research is conducted. There are many enlightened leaders in Pakistan. As an article that Franz co-wrote with James LeDuc finds, a leader who engages his or her staff is more likely to prevent an employee who is disgruntled from doing something harmful.¹¹ This is an area which many leaders in public health in the United States have not sufficiently explored. The goals of research are not to produce safety or security, but rather to provide benefits in the areas of public health, food, and energy. Organizations do need structure and security. To conduct research well, in a global networked life-sciences enterprise, organizations also need good leadership.

During the discussion period, Franz underscored the importance of leadership extending across an entire institution. In response to a question

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⁹ Oyt, K. 2012. Long Shot: Vaccines for National Defense. Cambridge, MA: Harvard University Press.

¹⁰ Covey, S. M. R. 2006. The Speed of Trust: Why Trust Is the Ultimate Determinate of Success or Failure in Your Relationships, Career and Life. London: Simon & Schuster.

¹¹ Franz, D. R., and LeDuc, J. W. 2011. Balancing our approach to the insider threat. Biosecurity and bioterrorism: biodefense strategy, practice, and science, 9(3), 205–206. doi: 10.1089/bsp.2011.0052.

about approaches to biosafety and biosecurity training in the United States for housekeeping staff at laboratories, he recounted his experience as commander of the U.S. Army Medical Research Institute of Infectious Diseases. Franz recalled that he had a wonderful biosafety officer who engaged actively with not only the scientists and technicians, but also the housekeeping staff. They were all included in a whole-of-organization approach. He asked everyone how he could help everyone do their jobs better. Today, training and oversight—of all staff—are more highly regulated in the United States, requiring everyone to follow detailed procedures and other measures.

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) of Pakistan to assist Ph.D. candidates and noted that issues related to security and safety are to be included. Through this and many other programs, Pakistan is a leader in responsible conduct of science. Safety and security cannot be simply an obligation that is discussed, it should be built into education. Professors and teachers have a responsibility to address safety and security. The job is not only about teaching facts to the next generation, but also about creating good scientists by discussing misconduct, questionable research practices, and related matters. Scientists also need to think about the international effects of their research as it pertains to safety and security. One such issue is dual-use technologies, and Shinwari noted that information technology coupled with biotechnology can be considered a dual-use area of activity.

For the past seven or eight years, Shinwari has taught a course at Quaid-i-Azam University to undergraduate- and graduate-level life science students on biosecurity and biosafety. Biosafety is being implemented throughout the country, and courses on biosafety and disaster management will soon be taught nationwide. As part of this national initiative, a taskforce is working on policy development and legislation. Sometimes, however, there is a disconnect between the media and scientists; the media often mischaracterizes the issues. Senior scientists should do what they can for the future. Many have influence with the government and can build bridges and find solutions, Shinwari said. International linkages involving academics, vice chancellors, and others are also critical to success.

Following his prepared remarks, and in response to a question raised about incentives and recognition for scientists who not only conduct important and relevant research, but also do so in a responsible and ethical manner, Shinwari referred to recent efforts at HEC to undergo a transformation from oversight of 60 universities to 180 as the number expands in Pakistan, which raises issues of quality assurance. While these are real challenges, Shinwari urged acknowledgement of the efforts of senior leadership, and sounded a note of optimism about positive changes under way, including the effort to formally recognize researchers’ contributions to society.

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. The Pakistan Academy of Sciences commissioned a survey, which attempted to catalogue as many labs as possible. It was noted that approximately 9,800 entities (public and private) are involved in clinical laboratory functions across complex and varied geographic, social, and political spaces in Pakistan. The survey, conducted by a local consultant, counted 763 laboratories and 636 hospital laboratories totaling 1,399 public and private laboratories.¹³ The survey divided the laboratories into 12 segments based on approach/capabilities and broad geographic areas. Market segments (e.g., public, private, and subcategories) and level of lab automation (e.g., complete automation, semiautomation, and manual) are described, but not associated with specific labs. Leading hospitals and labs that have established collection points are listed as top

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¹² For more information, see http://www.emro.who.int/pak/programmes/health-system-strengthening-hss.html.

¹³ Ikram, A. 2016. Strengthening and Sustaining a Network for Public and Animal Health Clinical Laboratories in Pakistan. A Joint Pakistan-U.S. Workshop on Strengthening and Sustaining a Network of Public and Animal Health Clinical Laboratories in Pakistan. Islamabad, September 27-29.

diagnostic labs (11) and specialty labs (26).¹⁴ Information technology capabilities vary from Wi-Fi internet access and 3G mobile internet to flip phones with SMS capabilities. Most professionals working in the labs, even from some of the more remote places represented at the workshop, are dedicated, but it is clear that in some places resources are very limited and more education and training is needed. Private-sector laboratories are in well-established hospitals or medical labs, or operate as independent labs although the majority of private labs are not located in designated laboratory buildings. More than 700 private labs operate throughout the country. Dedicated national institutes include the National Institute of Health, Pakistan 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. The country lacks architects and engineers to design, construct, and maintain labs. There is also inadequate engineering and financial support for infrastructure maintenance.

Regulatory and Legal Frameworks

Healthcare regulations are in place in Punjab, Khyber Pakhtunkhwa, and Baluchistan provinces for lab-related issues. National Biosafety Rules were established in 2005 by the Environmental Department.¹⁶ In terms of regulations for notifiable diseases, mechanisms of notification and a list of human and zoonotic notifiable diseases are in development. Many institutes have their own bioethical committees.

The One Health concept is not universally understood at all levels of the Pakistani lab network, even though the legal framework exists for labs to address One Health. Policies in many labs are inadequate. There is also the absence of a national regulatory agency for licensing of labs, which would assist with continuity, consistency, implementation, monitoring

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¹⁴ Ibid.

¹⁵ Ibid.

¹⁶ Pakistan Ministry of Environment. 2005. Pakistan Biosafety Rules. http://www.fao.org/faolex/results/details/en/c/LEX-FAOC053471.

and enforcement of policies, rules, and regulations. However, licensing and registration recently started in Khyber Pakhtunkhwa and Punjab.

Coordination and Networking

The Pakistan National Laboratory Working Group (NLWG) has representatives from various sectors and has programs and networks related to malaria and tuberculosis (TB). The TB program in particular has a mix of public and private labs, and there is some lab-based surveillance and data sharing related to TB, dengue, Crimean-Congo hemorrhagic fever, and influenza. Professional associations representing the medical, veterinarian, and agriculture sectors can collaborate under the One Health concept, Ikram said.

In practice, however, there is a lack of coordination among labs because the network structure is not well defined. There is also a lack of coordination between the human and veterinary public health sectors and a lack of tiered lab networks. In addition, there is a lack of integrated disease surveillance programs backed by a network of public health laboratories.

Accessibility and Finance

A basic package of diagnostic tests is available for free in many public health and veterinary labs. When these tests are insufficient, specimen transport can increase accessibility to needed diagnostics, but an unequal distribution of lab services exists, especially in rural areas. Private health insurance also results in differentiated access, explained Ikram.

The government has made investments in some labs related to staffing, supplies, and equipment. Certain public labs generate income, and there was a Global Fund Grant available through December 2017. Other funds are available from the World Health Organization (WHO), the U.S. CDC, Ministry of Food Security and Research, and other entities, for public health, zoonotic diagnosis, and surveillance.

Human Resource Management

Staff competence throughout the laboratory system is improving because of better training programs. Government and private institutes offer courses, and there is excellent structured training for pathologists. Institutes offer lab technology courses, continuing medical education, and

training workshops. However, Ikram cautioned that many laboratories do not have organizational charts or job descriptions with defined qualifications, competences, and skills. There is a lack of qualified, experienced lab managers; the position does not even formally exist in most public labs. The staff-to-workload ratio does not always allow for tasks to be accomplished as effectively and efficiently as possible. There are also high turnover rates in private labs.

Equipment and Consumables

International suppliers and reputable companies do operate in Pakistan, and some consumables are manufactured locally. There are rapid diagnosis kits available for some diseases, and some reagents and kits are tax-exempt. However, there is no regulatory authority for ensuring the quality of equipment and consumables. Maintenance of equipment is weak, with an inadequate system for standardization, calibration, and certification, Ikram said. Typically, budgets for equipment procurement and maintenance are limited, and the public procurement process is time-consuming and lengthy.

Quality Management Systems

The Pakistan National Accreditation Council (PNAC) provides accreditation according to international standards. Some labs are International Organization for Standardization (ISO) accredited, and there is an awareness among the staff about the importance of quality and accreditation/certification. Quality control (QC) standards and standard operating procedures tend to be only partially introduced. A system of external quality assessment (EQA) is available in the country, but quality assurance (QA) testing is not universally implemented. There is no EQA program for One Health, and few people are trained in QA/Laboratory Quality Management Systems. Few materials meeting QC standards are produced locally, and there are no dedicated budgets at the lab level to sustain internal and external QA programs. Overall, Ikram said, there is a lack of accountability for implementation of quality measures.

A biorisk management policy is under development in Pakistan with input from the NLWG. Private companies are available for collection of biological waste, with involvement of the Pakistan Biological Safety Association. Biosafety awareness is growing among lab staff, with biosafety and waste management training increasingly available; yet, there is little in the

way of occupational health for lab workers, and workers often do not use personal protection equipment at some labs. Well-developed management systems are absent in most medical, veterinarian, and agricultural labs. 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) is partially available, and many higher-level labs have Internet service. There is a partial online data exchange system, but mobile phone communication can be used for data exchange and reporting. Trained bioinformatics specialists are available, and almost all labs have landlines. However, there is a lack of computer proficiency in many labs and a lack of comprehensive utilization of LIMS. There is also a lack of integration of lab data into centralized databases, and insufficient data security and confidentiality. Security data backup facilities are not available. Lab data are insufficiently used for surveillance and epidemiology, said Ikram. There is partial intersectoral data exchange for One Health.

A National Health Information System supports the dissemination of information for healthcare managers by ensuring timely availability and use of accurate information at all levels. Pakistan’s District Health Information System (DHIS) is a mechanism of data collection, transmission, processing, analysis, and information feedback to the first-level care facility at the primary and secondary levels. Key achievements since strengthening the DHIS include establishing the Commission for Information and Accountability Initiative, as well as carrying out initiatives on e-Health and civil registration and vital statistics, Ikram shared.

Shortcomings of the current information systems in Pakistan include the fact that most public hospitals maintain their own information system without a regular reporting mechanism, Ikram explained. No centralized system exists to gather information from the large private sector. There is a lack of support for data collection and generation. No public health lab network exists in the provinces, and LIMS is not integrated into the main health information system (HIS). WHO provides training on new tools for situational analysis, and capacity building in areas such as data management and analysis, human resource information systems, and development of analytical reports. It also strengthens the capacity of provincial HIS units in the use of information systems.

Intermediate Steps and Future Goals

In the medium term, efforts are under way to strengthen existing public-sector labs, to use data more effectively, and to establish the Disease Early Warning System and a syndromic surveillance network. In addition, there should be improved coordination between clinical and veterinary labs, perhaps through combined training opportunities. Collaboration can aid in meeting challenges collectively, harmonizing efforts, avoiding duplication, and effectively utilizing limited resources. Embracing the One Health concept will strengthen the laboratory system; assist in the establishment of accreditation and certification bodies, as well as auditing and licensing bodies; and encourage an interdisciplinary approach to address infectious diseases.

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. Up-to-date pre-service and in-service training programs will be used with well-trained quality staff who are dedicated and well paid. At all levels of laboratory networks, technical staff will perform evidence-based quality-assured lab tests using quality equipment and consumables, standardized methodologies, and ethical practices. All laboratories will be registered and licensed based on defined minimum standards and widely established EQA programs, and laboratories will be encouraged to pursue accreditation. Proper biorisk management, infection control, and waste disposal systems will be implemented in all laboratories.

ACCREDITATION OF MEDICAL TESTING LABORATORIES ACCORDING TO ISO/IEC 15189

Ismat Gul Khattak, Director General of the Pakistan National Accreditation Council, began her presentation by underscoring the need for laboratories to become accredited because accurate treatment of patients depends on accurate results from lab tests, and accredited labs are more likely

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¹⁷ National Institutes of Health. 2017. National Laboratory Policy. https://www.nih.org.pk/wp-content/uploads/2018/06/National-Laboratory-Policy.pdf.

to produce accurate results. According to the ISO and the International Electrotechnical Commission (IEC), accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. ISO/IEC 17025 covers animal diagnostic and forensic laboratories. ISO 15189 covers human testing/clinical laboratories. Accreditation benefits the laboratories, regulators, and users. For the laboratory, accreditation provides a marketing tool to show compliance with international standards, competence, and reliability. Regulators benefit through more reliable testing results, reduced cost of market surveillance and less regulation, and increased transparency. Users benefit from reduced risk of incorrect results, more reliable service, trusted test results, and better diagnostics. Accreditation can also result in economic benefits, as indicated by a study of accreditation in the United Kingdom.¹⁸

Khattak reviewed the elements examined during the accreditation process in Pakistan. 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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¹⁸ See Frenz, M., and R. Lambert. 2013. The Economics of Accreditation. Project Report. Birkback, University of London. http://eprints.bbk.ac.uk/10499.

CORE COMPETENCIES AND REQUIRED EQUIPMENT FOR AN EFFECTIVE LABORATORY SYSTEM

Khalid Naeem Khawaja introduced his presentation by defining key terms. He defined Public Health Laboratories (PHLs) as a network of governmental public health, environmental, and agricultural laboratories (covering animal health). He noted that use of this term to cover the different types of labs is not applicable in all countries. He defined One Health as a strategy for expanding interdisciplinary collaborations and communications for optimal health outcomes at the intersection of humans, animals, and their environments.

The development of functional laboratory systems is increasingly recognized as a key component of sustainable health care systems. PHLs provide analytic biological and/or chemical testing and testing-related services to protect humans from diseases, environmental hazards, and other natural and human-made public health emergencies. PHLs have the capacity to carry out critical activities for safeguarding public health competently and effectively.

Competency Domains

A well-trained lab workforce is essential to carrying out this mission. While countries have developed competency guidelines, most of the guidelines originate from the U.S. CDC or the Association of Public Health Laboratories in the United States. Khawaja detailed the importance of creating competent laboratories. PHL employees should have competency in 15 domains (for a total of 122 competencies and 519 sub-competencies). The 15 domains are as follows: (1) quality management systems, (2) ethics, (3) management and leadership, (4) communication, (5) security, (6) emergency management and response, (7) workforce training, (8) surveillance, (9) general laboratory practice, (10) safety, (11) informatics, (12) microbiology, (13) chemistry, (14) bioinformatics, and (15) research.

These domains can be grouped into three large domains: general, cross-cutting technical, and specialized. Many of the competencies are overlapping and indeed fall under more than one domain. The purpose of the competencies is to delineate the essential knowledge, skills, and abilities that are critical to the effective performance of work by an individual at a PHL. Competencies improve the workforce by providing a guiding framework for producing education and training programs, identifying worker

roles and job responsibilities, and assessing individual performance and organizational capacity. Because the competencies are universal in nature for many laboratory disciplines, the proposed guidelines have potential value for countries with varying resources and can be re-adjusted according to resource limitations.

Competencies in the following seven areas fall under the general domain:¹⁹

• Quality management systems: systematic approaches to ensuring consistent quality of tests performed, products created, data generated, and results reported through a culture of quality.
• Management and leadership: the qualities that allow for the establishment of the purpose and strategic direction of the organization, involving innovation, influence, and motivation.
• Ethics: the knowledge, skills, and abilities needed to fulfill basic responsibilities to perform in a collegial and ethical manner within a laboratory setting.
• Communication: clear and concise transfer of information is necessary for the optimal operation of a public health laboratory.
• Security competencies: the knowledge, skills, and abilities necessary to ensure a safe and secure working environment that meets or exceeds applicable regulatory requirements and guidelines.
• Emergency management and response: the knowledge, skills, and abilities needed to mitigate, prepare for, respond to, and recover from laboratory-specific emergency events and situations.
• Work force training: guidance to staff members on subject matter expertise and project management for the development and delivery of training.

The main competencies in the cross-cutting technical domain are:

• General laboratory practice: the set of foundational knowledge and capabilities needed for the testing of samples across the wide spectrum of scientific and technical activities of public health laboratories.

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¹⁹ CDC. 2015. Competency Guidelines for Public Health Laboratory Professionals. https://www.cdc.gov/mmwr/pdf/other/su6401.pdf.

• Safety: the knowledge, skills, and abilities necessary to ensure a safe working environment that meets or exceeds applicable regulatory requirements and guidelines, including recognizing hazards and developing ways to counter the hazards.
• Surveillance: the ability of laboratory professionals to conduct surveillance, testing, reporting, and disease and exposure monitoring.
• Informatics, information science, computer science, and information technology: the hardware, software and know-how necessary to support public health practice, research, and learning.

Competencies in the specialized domain include:

• Microbiology: the scientific study of microorganisms and infectious agents as applied to the diagnosis, treatment, and prevention of disease, disability, and death. Microbiology includes the sub-specialties of virology, mycology, parasitology, mycobacteriology, and bacteriology that are encompassed in the disciplines of clinical, food, and environmental microbiology. It encompasses the knowledge, skills, and abilities needed to safely and securely detect, identify, and report infectious agents of concern to the public while following the laboratory path of workflow. Microbiology is critical to the public health role of detecting and identifying outbreaks, emerging diseases, and biological threats.
• Chemistry: the science of detection, measurement, and characterization of chemicals of public health importance in samples. 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. They also aid in the response to chemical emergencies or chemical terrorism events by providing rapid and definitive testing to identify and quantify chemical agents.
• Bioinformatics: the knowledge, skills, and abilities needed to collect, classify, and analyze biological and biochemical information through the development and use of computer databases, algorithms, and statistical techniques. Bioinformatics is the field of science that bridges the gap between biology, computer science, and

• information technology by merging them into a single discipline. Bioinformatics capability and capacity have become progressively more important within public health laboratories because of rapid advances in molecular technologies and laboratory techniques.
• Research: a systematic investigation designed to develop or contribute to existing knowledge. Research addresses the knowledge, skills, and abilities needed to conduct a systematic, hypothesis-driven investigation that includes research development, testing, and evaluation designed to advance public health knowledge, methods, and/or practice. It is critical to the public health enterprise, as communities are continually challenged with new diseases and unknown environmental public health threats. The equipment required in each lab is based on the type of work carried out in that lab. Equipment must be obtained from a source that can provide reliable calibration, validation, and after-sale support. Clinical labs have minimal equipment requirements, while reference labs or accredited labs require superior equipment. A basic in-house equipment maintenance set-up is essential to run a sustainable lab.

Conclusion

Khawaja summarized his presentation by saying that the competencies outline the knowledge, skills, and abilities needed by the PHL workforce to fulfill the responsibilities and demands of working and running a lab in the PHL system. 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. Clear and well-developed job descriptions, sound curriculum for workforce training, and continuing education programs are also needed. Successful and sustained demonstration of these competencies depend on the resources available to fully adopt and implement them and on the receptivity of laboratory professionals across the spectrum of job positions and titles.

A workshop participant asked whether basic criteria should be established and enforced to provide for incentives and assurances of quality lab performance. Khawaja replied that this was a worthy goal, but underscored the need for leadership to bring it to fruition. He hoped that the Interna-

tional Health Regulations would aid in this effort. Ali Khan added that having a national lab system can help achieve the quality needed. Tiering the system can help by codifying which labs are to conduct which tests, etc. This requires a holistic, systematic approach.

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