Guidelines on the Prevention and Control of Tuberculosis in Ireland

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<strong>Guidelines</strong> on the Prevention and Control of Tuberculosis in Ireland 2010HSE/HPSCcontainment.Although the Seventh Schedule recommends the following points, the National TB Advisory Committee isproposing that these recommendations outlined below should be considered compulsory.• The workplace is to be separated from any other activities in the same building• The workplace is to be sealable to permit disinfection• The workplace is to be maintained at an air pressure negative to atmosphere• An observation window, or an alternative, is to be present, so that occupants can be seen and• A laboratory is to contain its own equipment.The decision to make this proposal has been influenced by looking at best international practice inrelation to the items that are recommended. In the UK, the Control of Substances Hazardous to Healthregulations 1994 (COSHH) implements the EC Biological Agents Directive. The Advisory Committee onDangerous Pathogens (UK) (ACDP) originally published the Categorisation of biological agents accordingto hazard and categories of containment (4 th edition) 1995. 199 This guidance has now been replaced by Themanagement, design and operation of microbiological containment laboratories, 2001. 200 This publicationcomplements the Health and Safety Commission’s Health Service Advisory Committee’s (HSAC) guidanceon Safe working and the prevention of infection in clinical laboratories and similar facilities 201 and the ACDPpublication Biological agents: Managing the risks in laboratories and healthcare premises. 202 Under thisguidance the above recommendations are compulsory.In the USA, laboratories performing functions at ATS level 2 or 3 must use Biosafety Level 3. Biosafety level3 is very similar to Containment Level 3 (CL3) and the above recommendations are included as rules. 114;203Finally, a CL3 Laboratory will fail to achieve accreditation with Clinical Pathology Accreditation (UK) Ltd ifthese recommendations are not in place.Recommendation:Recommendations in the Seventh Schedule of the S.I. No. 146/1994 Safety, Health andWelfare at Work (Biological Agents) Regulations 1994 should be interpreted as mandatory inrelation to working with M. tuberculosis complex.TransportationThe transport of infectious substances by road, rail, sea and air are each the subject of internationalregulation, whose whole description is beyond the remit of these guidelines. The relevant legislation inIreland for transport by road is the “Carriage of Dangerous Goods by Road” Regulations 2007 StatutoryInstrument No. 288 of 2007 204 and the 2007 ADR regulations. 205SpecimensBiological substances that have been correctly classified as UN No. 3373 which are packaged and markedin accordance with packaging instruction P650, are not subject to any other requirements of the 2007 ADRregulations. This implies that provided the correct packaging is used, there is no requirement for any ADRdocumentation or for the requirement to have specially marked and equipped vehicles or trained drivers.In summary, any method of transportation can be used to transport patient specimens by road onceproperly packaged and labelled.CulturesFor transport purposes, pathogens are assigned to two categories, A and B. Category A includes thehigher risk infectious microorganisms such as M. tuberculosis complex but only when it is present as aculture. Nevertheless, when cultures that are being transported by road are intended for diagnostic orclinical purposes (not research), they may be classified as infectious substances of Category B. Infectioussubstances in Category B shall be assigned to UN No. 3373 and the proper shipping name of UN No. 3373-57-
<strong>Guidelines</strong> on the Prevention and Control of Tuberculosis in Ireland 2010HSE/HPSCis “BIOLOGICAL SUBSTANCE, CATEGORY B”. These are transported in accordance with ADR packagingregulations P650.However, at the time of publication of this document, when cultures of M. tuberculosis complex arebeing transported by air or sea they must follow the International Air Transport Association (IATA) andthe International Maritime Dangerous Goods (IMDG) regulations, that currently assign M. tuberculosisto Category A and they must be transported as UN No. 2814 “INFECTIOUS SUBSTANCE AFFECTINGHUMANS” and packaged in accordance with packing instruction P620. 205 This is most easily achieved byusing an approved and licensed courier.M. tuberculosis complex outside the CL3 laboratoryIt is worth noting that M. tuberculosis has been recovered from many body sites. 206-209 It follows thereforethat appropriate risk assessments with regard to M. tuberculosis are carried out when processing samplesfor other pathogens in other parts of the laboratory. This is especially so when an extended incubation timeis applied to recover fastidious pathogens. The observation that M. tuberculosis can be grown within sixdays on blood agar and that blood agar is at least as efficient as Lowenstein Jensen medium in recoveringM. tuberculosis from respiratory and lymph node aspirates must be considered when performing riskassessment analysis for other procedures in the microbiology laboratory. 210 Respiratory specimens, inparticular, may contain viable M. tuberculosis organisms and there are recommendations that these shouldbe analysed in a CL3 facility. 199;211Recommendation:All relevant legislation (national and international) for the transport and handling of specimensand cultures for tuberculosis should be strictly adhered to at all times.Molecular testingTests involving molecular methods do not require CL3 practices after the organism has been rendered nonviable.This is normally achieved through the application of heat. Some systems have been shown not torender the cultures completely unviable and therefore a laboratory must be able to definitively state anddemonstrate over time that any protocol in use for extracting mycobacterial DNA/RNA has succeeded inrendering the sample non-infectious before its removal from a CL3 facility. Methods which have producedconsistent killing of all mycobacterial species tested are those by which the tubes were fully immersed inboiling water or within a forced-hot-air oven set at 100 o C. 212-214AuditThere should be regular safety audits of the CL3 premises and processes.4.8 Quality AssuranceModern laboratory practice necessitates participation in both an internal and an approved external qualityassurance scheme e.g. United Kingdom National External Quality Assessment Service (NEQAS). Qualityassurance is a system that monitors and improves the efficiency and reliability of the laboratory service bypaying attention to detail at every step. There are three phases to the process as follows:Pre-analytical activities• How the test is ordered• Specimen collection procedures• Transport to the laboratory• Specimen handling and storage and• Completeness of patient information.-58-
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Guidelines on the Prevention and Control of Tuberculosis in Ireland

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