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L.S. 465.03 Regolamenti dwar il-Kontroll tal-Leġjonella

[ S.L.465.03 CONTROL OF LEGIONELLA 1 SUBSIDIARY LEGISLATION 465.03 CONTROL OF LEGIONELLA REGULATIONS 10th January, 2006 LEGAL NOTICE 5 of 2006, as amended by Legal Notice 262 of 2006. 1. The title of these regulations is the Control of Legionella Regulations. 2. In these regulations, unless the context otherwise requires: "accreditation" means third-party attestation by the Maltese National Accreditation Body or by any other accreditation body as recognised by the Maltese National Accreditation Body, in accordance with the Establishment of the Accreditation Directorate Order, of a laboratory, conveying formal demonstration of its competence to carry out specific test; Citation. Definitions. Amended by: L.N. 262 of 2006. S.L. 419.05 "accredited laboratory" means a laboratory to which accreditation has been granted according to the requirements of MSA ISO/IEC EN 17025; "the Act" means the Public Health Act; "authorised officer" means any duly qualified person authorised by the Superintendent to carry out any functions under these regulations and includes any nominated officer; "biocide" means a physical or chemical agent capable of killing micro-organisms, including Legionella; "clean" means to render free from visible sludge, foam, slime (including algae and fungi), rust, scale, dirt, and any deposit or accumulation of impurities or other foreign material; "cold water system" means an installation of plant, pipes and fittings in which cold water is stored, distributed and subsequently discharged; "cooling tower systems" includes: (

  1. a)a cooling tower, or a number of interconnected cooling towers that use the same recirculating water; and (
  2. b)any machinery that is used to operate any such tower; and (
  3. c)any associated tanks, pipes, valves, pumps or controls; "cooling tower" means a device whose main purpose is to cool water by direct contact between that water and a stream of air; "designated area" means any premises or part thereof to which the public or a section of the public has access, whether on payment or otherwise; "disinfect" means to carry out a process which is intended to kill or remove pathogenic micro-organisms; "drift" means the water aerosol which emerges from the airflow Cap. 465. 2 [ S.L.465.03 CONTROL OF LEGIONELLA outlet of a cooling system; "evaporative condenser" means a device whose main purpose is to cool a fluid by passing that fluid through a heat exchanger which is itself cooled by the contact of water passing through a stream of air; "guidelines" means the European Guidelines for Control and Prevention of Travel Associated Legionnaires’ Disease produced b y t h e E u r o p e a n Wo r k i n g G r o u p f o r L e g i o n e l l a I n f e c t i o n s (EWGLI) and endorsed by the Committee for the Epidemiological Surveillance and Control of Communicable Diseases in the Community, instituted by Decision 2119/98/EC of the European Parliament and the Council; "heat exchanger" means a device for transferring heat between fluids which are not in direct contact with one another; "heterotrophic colony count" means an estimate of the number of viable units of bacteria per millilitre of water made using the pour plate, spread plate or membrane filter test (also known as the total bacterial count, total plate count or viable bacterial count test) method; "legionella" means bacteria belonging to the genus Legionella; "premises" includes all non-domestic premises used for or in connection with the carrying on of a trade or business (whether for profit or not) and should include any healthcare facility and schools; "responsible person" includes the person who owns, manages or controls the cooling tower systems, or evaporative condensers, or hot and cold water systems, or water fountains or a number of these systems in the same premises; "sentinel taps", in relation to a hot water system, means the first and last taps on a recirculating system. For cold water systems (or non-recirculating hot water systems), the nearest and furthest taps from the storage tank. The choice of sentinel taps may also include taps which are considered to represent a particular risk; "spa pool" includes a bath or a small pool where warm water is constantly recirculated, through high velocity jets or with the injection of air to agitate the water; "the Superintendent" means the Superintendent of Public Health; "warm water system" means a piped water supply, including any thermostatic mixing valve, which is designed to supply water at a temperature of between 30ºC and 60ºC; "water" means water supplied through the main water distribution system or water supplied by an authorised private water supplier or through a water supply approved by the Superintendent or by the relevant competent authorities; "water fountain" means any water feature located in a designated area. CONTROL OF LEGIONELLA [ S.L.465.03 3.

(1)Cooling tower systems and evaporative condensers are prohibited to be newly installed on healthcare facilities and schools.
(2)Installation of new cooling tower system or evaporative condenser on any other premises should be restricted to those cases only where no other suitable dry cooling facility is possible as an alternative. 4.
(1)At the stage of installation of cooling tower system or an evaporative condenser, inspection shall be carried out by competent persons so that the cooling tower and evaporative condenser pose minimal health risk to occupants of the premises and members of the public. 3 Installation of new cooling tower systems and evaporative condensers. Design and construction of cooling tower system and evaporative condenser.
(2)Cooling systems shall be designed and constructed so as to minimise the release of drift and to aid safe operation, regular cleaning and disinfection.
  1. The cooling tower or evaporative condenser shall be located at least five metres away from air circulating and ventilating inlets, open windows and occupied areas, pedestrian thorough fares, traffic areas, areas of public access, exhaust discharge from kitchens, air handling systems or other areas where nutrients conveyed from these systems could assist in the growth of legionella. Location of cooling towers and evaporative condensers.
  2. Make-up water shall be supplied either through the main distribution system or by an authorised water supplier or through a water supply approved by the Superintendent. Source of water. 7.
(1)Effluent water from cooling towers and evaporative condensers shall be discharged into the public sewers as approved by the respective competent authorities. Discharge of water.
(2)The concentration of chemicals in the effluent shall be within the limits established by the respective competent authorities. 8.
(1)Cooling towers and evaporative condensers shall be commissioned, approved and certified by a competent warranted engineer in terms of the Inġiniera Act before use to ensure that they operate correctly and safely. Commissioning and operation. Cap. 321.
(2)The entire air-conditioning system shall be clear of any construction debris and dirt, and cleaned before operation starts.
(3)Precautions shall be taken to control the risks during commissioning, start up and during the normal operation of the system as per guidelines. 9. It shall be the duty of the responsible person to ensure that: (
  1. a)any cooling tower system or evaporative condenser in use is maintained and tested in accordance with the guidelines; (
  2. b)the water of the cooling tower system or evaporative condenser is maintained in a clean condition; Maintenance and testing of cooling tower systems and evaporative condensers. 4 [ S.L.465.03 CONTROL OF LEGIONELLA (
  3. c)the water of the cooling tower system or evaporative condenser is continuously treated with: Water quality and treatment. (
  4. i)one or more biocides to effectively control the growth of micro-organisms, including Legionella; and (
  5. ii)chemicals or other agents to minimise scale formation, corrosion and fouling; (
  6. d)a chlorine-compatible bio-dispersant is added to the recirculating water of the cooling tower system or evaporative condenser, and that the system is then disinfected, cleaned and re-disinfected: Disinfection, cleaning and redisinfection. (
  7. i)immediately prior to initial start up following commissioning, or any shut down period of greater than one month; and (
  8. ii)at intervals not exceeding six months; Routine inspections and testing. (
  9. e)the cooling tower system or the evaporative condenser are inspected in accordance with the guidelines and Schedule 1; Microbiological sampling frequency. (
  10. f)Water sampling. (
  11. g)a water sample shall be taken before the dosing of biocide and in accordance with the guidelines. Action levels following microbiological monitoring of cooling tower systems and evaporative condensers. 10.
(1)The responsible person must ensure that the actions following microbiological monitoring of cooling towers and evaporative condensers is in accordance with the procedures laid down in Schedule 2. at least once every month take a sample of the recirculating water of the cooling tower system and the evaporative condenser to an accredited laboratory for testing for heterotrophic colony count and once every six months for legionella;
(2)The responsible person shall immediately inform the Superintended of any situation provided for in Schedule 2.
(3)The responsible person shall carry out any further monitoring and remedial actions as m ay be directed by the Superintendent.
(4)The Superintendent may require the systems or part thereof to be shutdown until all necessary remedial actions have been taken by the responsible person and until microbiological sampling results of any system would have returned within the recommended acceptable levels as indicated in Schedule 2. Maintenance of hot and cold water systems. Start up procedures. 11. The responsible person shall ensure that: (
  1. a)unless the system is shut down or drained of water or is otherwise not in use, any hot and cold water system that the responsible person owns, manages or controls is maintained and tested in the manner set out in these regulations and according to the guidelines; (
  2. b)the hot and cold water system is disinfected by heat or chlorination and cleaned immediately prior to initial CONTROL OF LEGIONELLA [ S.L.465.03 5 start up following commissioning, or any shut down period of greater than one month; (
  3. c)the hot and cold water system is disinfected by one or more of the following methods: Routine disinfection. (
  4. i)at least once each month by heat or chlorination; or (
  5. ii)continuously by means of automatic low level chlorination; or (iii) continuously by means of ultra-violet light treatment; or (
  6. iv)a method approved in the guidelines; (
  7. d)the hot and cold water system is inspected and that the hot and cold water systems are maintained at all times in accordance with the guidelines and Schedule 1 and 3; Routine inspections and testing. (
  8. e)when biocides are used to treat water systems, they are meticulously controlled and checked at least weekly or as otherwise indicated to ensure that it is operating correctly; Biocide treatments. (
  9. f)at least once every six months a sample of the water from the hot and cold water system is taken and delivered to an accredited laboratory for testing and reporting on Legionella. Microbiological sampling frequency. 12.
(1)The responsible person must ensure that the actions following microbiological monitoring of hot and cold water systems are in accordance with the procedures laid down in Schedule 4. Action levels following microbiological monitoring.
(2)The responsible person shall immediately inform the Superintended of the situation provided for in Schedule 4.
(3)The responsible person shall carry out any further monitoring and rem edial actions as may be directed by the Superintendent.
(4)The Superintendent may require the systems or part thereof to be shut down until all necessary remedial actions have been taken by the responsible person and until microbiological sampling results have returned within the recommended acceptable levels in Schedule 4. 13.
(1)It shall be the duty of the responsible person to ensure that: Maintenance and testing of water fountains. (
  1. a)any water fountain under his responsibility is maintained and tested in accordance with the guidelines and Schedule 1; (
  2. b)water in a water fountain is sampled: (
  3. i)at least once a month for the purpose of determining the heterotrophic colony counts; and (
  4. ii)at least once every six months for the purpose of Microbiological sampling. 6 [ S.L.465.03 CONTROL OF LEGIONELLA detecting legionella bacteria.
(2)The responsible person shall immediately inform the Superintendent of the situation provided for in Schedule 2. Notice to carry out inspection, test or maintenance of water fountains.
(3)The Superintendent may require the responsible person to carry out tests and maintenance of water fountains as he may deem necessary. Maintenance and testing of other risk systems. 14.
(1)It shall be the duty of the responsible person to ensure that any spa pool and any other type of water system under his responsibility is maintained and tested in accordance with the guidelines and Schedule 1.
(2)Spa pools on display in retail outlets or exhibitions shall be treated in the same manner as if they were being used. Risk assessment. 15.
(1)The responsible person shall: (
  1. a)carry out a risk assessment to identify and assess the risk of exposure to legionella bacteria from work activities and the water systems on the premises under his control as identified in the guidelines; and (
  2. b)identify any necessary precautionary measures which may need to be adopted; and (
  3. c)review the assessment either annually or when the situation changes or when the original assessment may no longer be valid; and (
  4. d)keep a fully documented record of the risk assessment. Control measures.
(2)When the risk assessment reveals that there is a foreseeable risk which cannot be eliminated, the responsible person shall adopt a scheme specifying the measures to be taken to minimise the risk of exposure. External audit.
(3)The risk assessment and operation of the control measures shall be audited by an independent competent person at least every two years.
(4)All maintenance and risk assessment records shall be retained for at least five years. Action plan for an outbreak. 16.
(1)The responsible person shall inform the Superintendent of an outbreak of legionnaire’s disease or if it is suspected to have occurred.
(2)In the event or on the suspicion of an outbreak of legionnaires’ disease, the responsible person shall implement all instructions which may be issued by the Superintendent. Duties of the Superintendent. 17.
(1)It shall be the duty of the Superintendent to investigate any case or suspected case of Legionnaires’ disease at any premises and to cause the sampling and analysis of any samples required to investigate such case or suspected case. Initial investigations.
(2)The expenses incurred for the elevation, transportation, preparation and analysis of samples in case of initial investigation of a case or suspected case of legionnaire’ disease shall be encumbered by the Superintendent. CONTROL OF LEGIONELLA [ S.L.465.03
(3)If the results of the initial samples indicate the presence of Legionella species, or if the investigation is within twenty-four months of the first notified case or suspected case, the expenses of follow-up samples or initial samples, as the case may be, shall be encumbered by the responsible person: 7 Follow-up investigations. Provided that the responsible person of the premises shall sign a priori the declaration attached as Schedule 5 to these regulations confirming his acceptance to pay any fees due to the Superintendent.
(4)Any person who fails to comply with sub-regulation
(3)shall be guilty of an offence and the court, besides awarding punishment, shall oblige the accused to pay the due fees. 18.
(1)In the event that the responsible person fails to follow the instructions referred to in the preceding regulations, or the Superintendent considers that the risk of infection with legionella from that particular premises is significant, he may order that the premises, part of the premises or any water related system, be immediately closed until the risk of infection is controlled. Closure of premises.
(2)The Superintendent shall issue an enforcement notice to the responsible person and shall be in the form specified in Schedule 6, or in any other modified form as the Superintendent may deem appropriate in the particular circumstances. Enforcement notice.
(3)Once the premises, part of the premises or any water related system has been closed by an enforcement notice issued by the Superintendent, the same enforcement notice may be lifted only after it is confirmed by the Superintendent that the risk of infection has been controlled.
(4)Any person who fails to comply with the enforcement notice issued under sub-regulation
(2)shall be guilty of an offence under the Act. Failure to comply with the enforcement notice. 19. Any person who contravenes any of the provisions of these regulations shall be guilty of an offence under the Act. Offences. 8 [ S.L.465.03 CONTROL OF LEGIONELLA SCHEDULE 1 RECOMMENDED INSPECTION FREQUENCIES FOR RISK SYSTEMS CHECKLIST 1: COOLING WATER INSTALLATIONS SYSTEM/SERVICES TASK FREQUENCY C o o l i n g t o w e r s a n d Monitor water quality, water use and 6 monthly evaporative biocide/chemical use to assess and ensure condensers effectiveness of water treatment regime, including key chemical and microbiological parameters and observations of internal condition of pond, pack and water Central control function, conductivity M o n t h l y t o 3 sensor calibration, blow down function, m o n t h l y, u n i f o r m i t y o f w a t e r d i s t r i b u t i o n , according to risk condition of sprays/troughs, eliminators, pack, pond, immersion heater, fan and sound attenuators C l e a n a n d d i s i n f e c t c o o l i n g t o w e r s / 6 monthly evaporative condensers, make up tanks and associated systems, including all wetted surfaces, descaling as necessary. Packs should be removed and cleaned where practicable. CHECKLIST 2: HOT AND COLD WATER SERVICES SERVICES Warm water services Cold water services TASK FREQUENCY Arrange for samples to be taken from hot 6 monthly water heaters, in order to note condition of drain water Check temperatures in flow and return at Daily calorifiers Check temperature up to 1 minute to see Weekly if it has reached 50ºC in the sentinel taps Visual check on internal surfaces of Annually water heaters for scale and sludge C h e c k r e p r e s e n t a t i v e t a p s f o r Monthly temperature as above on a rotational basis Check tank water temperature remote 6 monthly from ball valve and mains temperature at ball valve. Note maximum temperatures recorded by fixed max/min thermometers where fitted CONTROL OF LEGIONELLA [ S.L.465.03 9 SERVICES TASK FREQUENCY Note: This temperature Check that temperature is below 20ºC Weekly may not be reached after running the water for up to 2 d u r i n g t h e s u m m e r minutes in sentinel taps months in Malta Visually inspect cold water storage tanks 6 monthly and carry out remedial work where necessary C h e c k r e p r e s e n t a t i v e t a p s f o r Monthly temperature as above on a rotational basis Shower heads Dismantle, clean and descale shower Quarterly, or as heads and hoses n e c e s s a r y, whichever comes first Little used outlets Flush through and purge to drain Weekly CHECKLIST 3: OTHER RISK SYSTEMS SYSTEM/SERVICES TASK FREQUENCY Spray humidifiers, air Clean and disinfect spray humidifiers/air 6 monthly w a s h e r s a n d w e t washers and make up tanks including all scrubbers wetted surfaces, descaling as necessary Confirm the operation of non chemical Weekly water treatment (if present) Water softeners Clean and disinfect resin and brine tank - A s check with manufacturer what chemicals recommended by can be used to disinfect resin bed manufacturer E m e r g e n c y s h o w e r s Flush through and purge to drain 6 monthly or and eye wash sprays more frequently if recommended by manufacturer Sprinkler and hose reel When witnessing tests of sprinkler blow Quarterly systems down and hose reels ensure that there is minimal risk of exposure to aerosols Lathe and machine tool C l e a n a n d d i s i n f e c t s t o r a g e a n d 6 monthly coolant systems distribution system Spa baths Check filters - sand filters should be Daily backwashed daily Check water treatment - pools should be 3 times daily continuously treated with oxidising biocide Clean and disinfect entire system Weekly Horticultural misting Clean and disinfect distribution pipe Annually systems work, spray heads and make-up tanks, including all wetted surfaces, descaling as necessary 10 [ S.L.465.03 CONTROL OF LEGIONELLA SYSTEM/SERVICES TASK FREQUENCY F o u n t a i n s a n d w a t e r Clean and disinfect ponds, spray heads Weekly features (particularly and make-up tanks, including all wetted indoors) surfaces, descaling as necessary SCHEDULE 2 ACTION LEVELS FOLLOWING MICROBIOLOGICAL MONITORING FORCOOLING TOWER SYSTEMS AND EVAPORATIVE CONDENSERS HETEROTROPHIC COLONY LEGIONELLA COUNT1 CFU/ ML AT 30ºC BACTERIACF U/LITRE 2 (Minimum 48 hours incubation) ACTION REQUIRED ON SYSTEM System under control NOTIFICATION TO SUPERINTENDENT <10,000 <1000 >10,000 and up to 100,000 >1000 and up to 10,000 Review programme operation - Following resampling and similar The count should be confirmed by c o u n t s a r e c o n f i r m e d , t h e immediate re-sampling. If similar Superintendent is to be informed in count is found again, a review of writing within 24 hours of receiving t h e c on t ro l m e a s u r e s a n d r i s k the laboratory report and should assessment should be carried out include copies of laboratory results to identify any remedial actions. together with the control measures being taken by the responsible person to remedy the situation. None >100,000 >10,000 Implement corrective action Once microbiological results The system should immediately indicate these levels of bacterial be re-sampled. It should then be c o u n t s , t h e r e s p o n s i b l e p e r s o n ‘shot dosed’ with an appropriate within 24 hours of receiving the biocide, as a precaution. The risk laboratory report shall inform the assessment and control measures Superintendent by phone and in should be reviewed to identify w r i t i n g w i t h i n 4 8 h o u r s w h i c h remedial actions. report should include copies of the laboratory results together with the control measures being taken to remedy the situation. 1 Colony count determined by pour plate method according to ISO 6222
(20)or by spread plate method on yeast extract agar 2 Determined in accordance with ISO 11731
(19)[ S.L.465.03 CONTROL OF LEGIONELLA 11 SCHEDULE 3 TEMPERATURE CONTROL FOR HOT AND COLD WATER SYSTEMS FREQUENCY CHECK STANDARD TO MEET COLD WATER HOT WATER NOTES Weekly Sentinel taps The water The w a t e r This check makes sure that temperature temperature should t h e s u p p l y a n d r e t u r n s h o u l d b e b e l o w b e a t l e a s t 5 0 º C temperatures on each loop 20ºC or less after within a minute of are unchanged i.e. the loop running the water running the water is functioning as required for up to two minutes Monthly If fitted, input to thermostatic mixer valves (TMV) on a sentinel basis The water supply to One way of measuring this the TMV is to use a surface temperature should temperature probe be at least 50ºC within a minute of running water Water leaving and returning to the water heater O u t g o i n g w a t e r If fitted, the thermometer should be at least pocket at the top of the hot 60ºC, return at least water storage heater and on 50ºC th e retu r n le g are use fu l points for accurate temperature measurement. If installed,these measurements could be carried out and logged by a building management system Six monthly I n c o m i n g c o l d The water should water inlet (at preferably be least once in the below 20ºC at all winter and once in times summer) The most convenient place to measure is usually at the ball valve outlet to the cold water storage tank Six monthly Representative The water The w a t e r This check makes sure that number of taps on t e m p e r a t u r e temperature should t h e w h o l e s y s t e m i s a rotational basis should be 20ºC or b e a t l e a s t 5 0 º C working properly less after running within a minute of the water for two running the water. minutes The difference between the highest and lowest temperature recorded at the taps after one minute should not be greater that 10ºC 12 [ S.L.465.03 CONTROL OF LEGIONELLA SCHEDULE 4 ACTION LEVELS FOLLOWING MICROBIOLOGICAL MONITORING FOR HOT AND COLD WATER SYSTEMS LEGIONELLA NOTIFICATION TO BACTERIA ACTION REQUIRED ON SYSTEM SUPERINTENDENT CFU/LITRE1 System under control None <1000 >1000 and Either: Following resampling and similar up to 10,000 (
  1. i)If only one or two samples c o u n t s a r e c o n f i r m e d , t h e are positive, systems should Superintendent is to be informed in be re sampled. If a similar writing within 24 hours of receiving count is found, then review of the laboratory report, and should the control measures and risk include copies of laboratory results assessment should be carried together with the control measures out to identify any remedial b e i n g t a k e n b y t h e r e s p o n s i b l e person to remedy the situation actions; (
  2. ii)If the majority of samples are positive, the system may be colonised, albeit at a low level, with Legionella. Disinfection of the system should be considered but an immediate review of control measures and risk assessment should be carried out to identify any other remedial action required. >10,000 The system should be re-sampled O n c e m i c r o b i o l o g i c a l r e s u l t s a n d a n i m me d i a t e r e v i ew o f t h e indicate these levels of bacterial c o n t r o l m e a s u r e s a n d r i s k counts, the responsible person within assessment carried out to identify 24 hours of receiving the laboratory a n d r e m e d i a l ac t i o n s , i n c l u d i n g r e p o r t shall inform the possible disinfection of the system S u p e r i n t e n d e n t b y p h o n e a n d i n writing within 48 hours which report should include copies of the laboratory results together with the c o n t r o l m e a s u r e s be i n g t a k en t o remedy the situation 1 Determined in accordance with ISO 11731
(19)CONTROL OF LEGIONELLA [ S.L.465.03 13 SCHEDULE 5 CONFIRMATION DECLARATION OF FEES DUE TO THE SUPERINTENDENT OF PUBLIC HEALTH The Superintendent of Public Health Health Division I, the undersigned, in my capacity of ................................................. (position) of .............................................. (premises name) hereby declare that I will pay, within one month’s time of receipt of invoice, all the expenses that the Health Division will incur in the sampling, transportation, preparation and analysis of ........... (number) of samples, which have been taken from ................................................(premises name and address) on the .................... (date of sampling) as part of the investigation of a case or suspected case of Legionnaire’s disease. (Sgd) Name and Surname o.b.o. I.D. No. Date of Birth Place of Birth Parent’s Name and Surname Residential Address Billing Address VAT No. Date 14 [ S.L.465.03 CONTROL OF LEGIONELLA SCHEDULE 6 HEALTH AUTHORITY ENFORCEMENT NOTICE (As per regulation 18
(2)of the Control of Legionella Regulations) Date: ........................................... To: ................................................ ................................................ ................................................
  1. Following investigations carried out by the Superintendent of Public Health, it was found that the risk of infection from Legionnaire’s Diseases is significant at ................................................................................................................................. .................................................................................................................................
  2. The risk of infection from Legionnaire’s Diseases relates to: ........................ ................................................................................................................................. .................................................................................................................................
  3. Without prejudice to the Superintendent’s right to take action in accordance with the provisions of the Control of Legionella Regulations, you are hereby requested to IMMEDIATELY close down the ............................................................ until further notice. Superintendent of Public Health

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