College of Medical Laboratory Science Sri Lanka ALS.SL My Ref: CMLSSL/Gen/2020 (02) Date: 29.01.2020 Mrs Badhrani Jayawardena Secretary Ministry of Health and Indigenous Medical Services No. 385, Rev. Baddegama Wimalawansa Thero Mawatha, Colombo 10 Dear Hon Minister Wanniarachchi Establishment of a WHO Recommended Laboratory to Test Samples of a Highly Infectious Nature WHO recommends that highly infectious samples be tested in a bio safety laboratory (BSL3+ / BSL4) type laboratories. Within Sri Lanka, we do not have access to such a facility. During the year 1992, under the ite (MRD) but the in have been made to construct as ance of JAICA a laboratory was established within the Medical Research In facility was not maintained since year 2002. Further, attempts and alloc: 4 BSL3 type laboratory at the same site but it had not been implemented stil. Asa result of the above members of the College of Medical Laboratory Science, Sri Lanka are exposed to n extremely dangerous environment resulting in the criticism of the whole healthcare delivery system. even to day the diagnostic tests relating to coronavirus is done at the MRI and Infectious seases Hospital (IDE) under a routine laboratory environment, During previous epidemic risks such as SARS and ebola members of our College taking into account the grave danger faced by the country had conducted their duties under vulnerable conditions. However, subsequent to the reduction of such an epidemic condition, over time the development of required laboratories have been only limited to a stock of basis diagnostic equipment. Therefore, as the body that is in the forefront of diagnostic activities in all the public hospitals in the country, we like to reiterate the importance of establishing a minimum of 3 BL$3+ / BSL4 type laboratories ea TES No. 25/2, Norris Avenue, Colombo 08, 1to counter epidemic conditions brought about by disease such as coronaviruses and any other similar Viruses and outbreaks in the future, We are attaching herewith a brief proposal and a rationale for the setting up of such a laboratory in Sri Lanka which has been a long felt critical need. ‘The basic proposal also outlines the type of equipment, estimated cost and the timeline associated. We are grateful if you could provide your approval to implement this project immediately taking into account the national importance. Your sincerely Ravi Kumudesh President - College of Medical Laboratory Science Sri Lanka CC: DDG (LS) DDG (MS) 2 ee No. 25/2, Norris Avenue, Colombo 08 2ESTABLISHMENT OF WHO RECOMMENDED LABORATORY TO TEST SAMPLES OF A HIGHLY INFECTIOUS NATURE WHAT IS BIOSAFETY The application of knowledge, techniques and equipment to prevent personal, laboratory and environmental exposure to potentially infectious agents or biohazards. Biosafety defines the containment conditions under which infectious agents can be safely manipulated. Containment * Containment ~ Safe methods for managing infectious agents in the laboratory environments X_ To reduce exposure of potentially hazardous agents 4 Types of Containment X_ Biological Containment (BC) X Physical Containment (PC) 4 Elements of Containment X Laboratory Practice and Technique Safety equipment (Primary barriers) X Facility Design (Secondary barriers) ‘THE NEED FOR BIOLOGICAL CONTAINMENT LABORATORY CAPACITY In the past century, medical research has led to improved health and increased life expectancy largely because of success in preventing and treating infectious diseases. This success has come about through the use of antibiotics and vaccines, improved hygiene, and increased public awareness. New threats to health continually emerge naturally, however, as bacteria and viruses evolve, are transported to new environments, or develop resistance to drugs and vaccines. Some familiar examples of these so-called emerging or re-emerging infections include HIV/AIDS, West Nile virus, severe acute respiratory syndrome (SARS) and annual outbreaks of influenza etc. To control epidemics and protect the public health, medical researchers must quickly identify naturally occurring microbes and then develop diagnostic tests, treatments, and vaccines for them. Preparing for bioterrorism—the deliberate release of a microbe into a community in which it isnot a current health concern—calls for the identical scientific skills and strategies. ‘CMLSSL Tel 077 307 7717A containment laboratory will ensure the safe handling of potential pandemic pathogens (PPPs) and other infectious agents in research and medicine; making accurate and rapid diagnoses for PPPs and other infectious agents to ensure appropriate medical care; detecting antimicrobial resistance in infectious agents; facilitating epidemiological investigations of infectious disease outbreaks; and detecting biological attack agents. * Diagnostics—identifying etiology + Supporting clinical care—identifying cases + Supporting epidemiology + identifying cases * identifying chains of transmission using modern molecular tools + Supporting and carrying out ecological investigations + Applied research + Testing and evaluating therapeutics—preclinical studies + Testing and evalu: ig va es + Basic research—developing pathways and targets for therapeutics and vaccines BIOSAFETY LEVELS, Biological Safety Levels (BSL) are a series of protections relegated to autoclave-related activities that take place in particular biological labs. They are individual safeguards designed to protect laboratory personnel, as well as the surrounding environment and community. These levels, which are ranked from one to four, are selected based on the agents or organisms that are being researched or worked on in any given laboratory setting. Laboratory facilities are designated as, Basic - Biosafety Level 1 - where work is done with defined and characterized strains of viable microorganisms not known to cause disease in healthy adult human X Basic ~ Biosafety Level 2 - where work is done with the broad spectrum of indigenous moderate-risk agents present in the community and associated with human disease of varying severity CMLSSL Tel O77 807 717X Containment ~ Biosafety Level 3 - where work is done with exotic agents, potential for infection by aerosols is real and serious or lethal consequences of disease X Maximum containment — high risk of life-threatening safety Level 4 - Dangerous and exotic agents with ease Biosafety level designations are based on a composite of the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups. CDC Biosafety Levels High Risk Torri an siga Ooo rN Ne os caused by these microbes ae fequenty fatal and without treatment oe vaccines. Microbes Examples: Ebola, Smallpox. ‘Miebesthere cane eter igeus eae zd they can case serious or potest etl dseasetreeughr espe tsnison, ‘amples, HN Fu, Yes pests The Pag, Terao SARS fails, Wes Nl Vins, ket ‘Worl potential arardopesne ad the ence es butane that aus ory mid disease to ua ora feta contrat via aerecina sting xa: Mow hanya Repti 8 an ie yee dase, atone mamgs, nd meas Not noun to content cave Sea ney altuna anf nina ental ado balay esonneandthe enionnest. Low Risk tals: canine hepatitis non gates Microbes Echeritia col and nn.nectioes ble, CMLSSL Tel 077 307 7717APPLICATION OF BIOSAFETY LEVEL 3 & 4 TYPES © BSL-3 LABORATORY Application Applicable to clinical, diagnostic, teaching, research, or production facilities in which work is, done wi igenous or exotic agents which may cause serious or potentially lethal disease after inhalation ‘Agents Classified Micro-organisms: Mycobacterium tuberculosis, Bird Fiu-Swine Flu virses, Pox Virus, Bacillus Anthracis, Bordetella Pertusis, Yersinia pestis, Francisella tularensis, Chlamydia psittaci, SARS coronavirus, Coxiella burnetii, rabies virus, Chikungunya, yellow fever virus, Leishmania donovani etc. © BSL-4 LABORATORY APPLICATION Applicable for work with dangerous and exotic agents that pose @ high individual risk of aerosol- transmitted laboratory infections and life-threatening disease that is frequently fatal, for which ‘there are no vaccines or treatments, or a related agent with unknown risk of transmission. AGENTS: Classified Micro-organisms: Marbug virus, Ebola virus, Lassa virus, Crimean-Congo hemorrhagic fever, Hendra virus, Nipah virus, Flavivrusis, etc. SAFETY CRITERIA ‘Safety Criteria should be compiled with Good Large Scale Production (GLSP) X The host organism should not be a pathogen, should not contain adventitious agents, should have an extended history of safe use, or have built-in environmental limitations that permit optimum growth in the bioreactor but limited survival with no adverse consequences in the environment CMLSSL Tel 077 307 717% The vector should be well characterized and free from known harmful sequences; the DNA should be limited in size as much as possible to perform the intended function; X should not increase the stability of the recombinant in the environment unless that is a requirement of the intended function; X Should be poorly mobilisable X_ Should not transfer any resistance markers to microorganisms not known to acquire them naturally if such acquisition could compromise the use of a drug to control disease agents. “Risk assessment and Environment impact needs to be conducted CONSIDERATION IN THE DEVELOPMENT OF BSL FACILITIES * The laboratory shall be separate and stand alone * The laboratory rooms must be sealable for decontamination ‘© Entry for personnel must be through a vestibule * No entry for arthropods and vermin * Special considerations to be given to Radioactive activities/substance handled if any ® Access doors must be self-locking and interlocking © Break-through panel for emergency exit # Autoclave for decontamination © Surface of walls, ceiling, floor should be mon¢ jc water- resistant and easy to clean ‘© Allthe openings sealed to facilitate decontamination ‘© Air duct system must be constructed to prevent gaseous decontamination ‘* Allthe windows must be close-sealed and break-resistant ‘* Foot or elbow operated or automatically controlled water source near each exit door © Proper directional air-flow * No recirculation is permitted © Supply and exhaust through HEPA CMLSSL Tel 077 307 7717Bio-safety cabinets (BSC) away from walking areas Anti-back flow Effluent decontamination Incinerator provision LABORATORY EQUIPMENT Bio-safety cabinets for the activities involving infectious materials. Physical containment of devices Special personal protective equipment Biosafety Cabinet (BSC] — Class 11 B2 Si Waste Autoclave Pass through cabinets Effluent treatment and disposable system Waste Water Treatment Physical containment devices Special protective equipment CMLSSL Tel 077 307 717PROPOSED ARCHITECTURAL LAYOUT OF A BSL FACILITY f avroctavenoo < com, TESTING AND VALIDATION PARAMETERS * General specification and compliance check + HEPA filter leak test ~ according to the ISO 14644 + Factory ducting post welding leak test + Room differential pressure test verification + Pressure decay Test + Soap Bubble Test + Particle test for cleanliness; according to ISO 14644 + Air pattern smoke test + Light intensity test + Noise test + Air velocity test + BSC: as per NSF 49 standard CMLSSL Tel 077 307 7717cost LKR 250 million per facility (Estimate) TIMELINE 2 to 3 months for erection & installation CMLSSL Tel 077 207 7717