HTM 2022
HTM 2022
HTM 2022
Operational management
Health Technical Memorandum 2022
Crown copyright 1997. Published with permission of NHS Estates, an Executive Agency of the Department of Health, on behalf of the Controller of Her Majestys Stationery Office. Applications for reproduction should be made in writing to The Copyright Unit, Her Majestys Stationery Office, St Clements House, 216 Colegate, Norwich NR3 1BQ. First published 1997
ISBN 0-11-322068-5
Standing order service Are you making full use of The Stationery Offices Standing Order Service? The Standing Order Service is a free monitoring of the publications of your choice from over 4000 classifications in 30 major subject areas. We send you your books as they are published, along with an invoice. With a standing order for class 14.02.017 you can be supplied automatically with further titles in this series as they are published. The benefits to you are: automatic supply of your choice of classification on publication; no need for time-consuming and costly research, telephone calls and scanning of daily publication lists;
saving on the need and the costs of placing individual orders. We can supply a wide range of publications on standing order, from individual annual publications to all publications on a selected subject. If you do not already use this free service, or think you are not using it to its full capacity, why not contact us and discuss your requirements? You can contact us at: The Stationery Office Standing Order Department PO Box 276 London SW8 5DT Tel: 0171-873 8466; fax 0171-873 8222 We look forward to hearing from you.
Health Technical Memoranda (HTMs) give comprehensive advice and guidance on the design, installation and operation of specialised building and engineering technology used in the delivery of healthcare
They are applicable to new and existing sites, and are for use at various stages during the inception, design, construction, refurbishment and maintenance of a building.
Executive summary
This volume of Health Technical Memorandum (HTM) 2022 looks at issues of operational management. It covers such issues as statutory requirements, functional responsibilities, operational policy, operational procedures, training and communications, cylinder management, general safety, maintenance and risk assessment control of exposure to anaesthetic agents, giving definitions and working practices throughout. This volume is intended for use by operational managers, engineers, quality controllers, technicians, finance officers and other professionals involved in the day-to-day running of an MGPS. The primary objective of this volume is to ensure the provision of safe and reliable MGPSs and their efficient operation and use. This objective will only be achieved if the medical and nursing users, and estates staff participate in the introduction of an operational policy designed to minimise the hazards likely to arise from misuse of the system. A MGPS is installed to provide a safe, convenient and cost effective system for the provision of medical gases to the clinical and nursing staff at the point of use. It reduces the problems associated with the use of gas cylinders such as safety, porterage, storage and noise.
The guidance given in this HTM should be followed for all new installations and refurbishment or upgrading of existing installations. It is not necessary to apply the guidance retrospectively unless patient or staff safety would be compromised. In this case, the guidance given in this HTM should be followed. Existing installations should be assessed for compliance with this HTM. A plan for upgrading the existing system should be prepared taking account of the priority for patient safety. Managers will need to liaise with medical colleagues and take account of other guidance published by the Department of Health in order to assess the system for technical shortcomings.
Contents
About this publication Executive summary 1.0 1.1 1.10 1.13 2.0 2.1 3.0 3.2 3.3 3.4 3.5 3.6 3.7 3.10 3.11 3.12 3.16 3.21 3.23 4.0 4.1 4.6 4.7 4.8 4.13 4.15 4.24 4.26 4.28 5.0 5.1 5.3 5.20 5.22 5.23 5.26 5.31 Scope page 3 General Operational management Other guidance Functional overview page 5 Basic description of an MGPS Statutory requirements page 8 Health and Safety at Work etc Act Management of Health and Safety at Work Regulations 1992 Work Place (Health, Safety and Welfare) Regulations 1992 Provision and Use of Work Equipment Regulations 1992 Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1985 Manual Handling Operation Regulations 1992 Personal Protective Equipment at Work Regulations 1992 Electromagnetic Compatibility Regulations 1992 COSHH Regulations Pressure Systems and Transportable Gas Containers Regulations Highly Flammable Liquids and Liquid Petroleum Gas Regulations Medicines Act Functional responsibilities page 12 General Management Key personnel Executive manager Estates management Authorised person (MGPS) Competent person (MGPS) Quality controller (QC) Designated medical or nursing officer Operational policy page 16 General Operational considerations Emergency procedures Power supply failure Record drawings Locking of valves and plantrooms for MGPS Monitoring of the operational policy
Contractors Medical equipment purchase Operational procedures page 21 Permit-to-work procedure Tests after work on the MGPS Procedure for cleaning contaminated vacuum systems Training and communications page 32 Training Communications Cylinder management page 33 Cylinder storage and handling Accommodation for medical gas cylinders Hazchem/warning signs Design and construction of cylinder stores Handling of cylinders Equipment for use with medical gas cylinders Precautions against leakage of gas Precautions against fire, heat and chemicals Cylinders involved in incidents Storage of cylinders in manifold rooms Storage of cylinders in ready-to-use stores Stock control and receipt of cylinders into stock Ordering from suppliers Returns to suppliers Issue from stores Return of cylinders to stores Receipt of cylinders into stock Labelling/marking of cylinders Restriction on use of storage accommodation Notices Access to manifold rooms and liquid oxygen storage areas Fire detection system Classification of hazardous areas for the selection of electrical equipment based on BS5345: Part 1: 1976 General safety and fire precautions page 47 General safety Safety statement for users of oxygen equipment Material compatibility Protective clothing for handling cryogenic gases Other medical gases Fire precautions Ventilation Maintenance page 52 General
7.0 7.1 7.8 8.0 8.1 8.10 8.18 8.11 8.23 8.45 8.47 8.55 8.61 8.62 8.64 8.71 8.72 8.73 8.74 8.75 8.76 8.78 8.83 8.86 8.89 8.90 8.91
9.0 9.1 9.9 9.16 9.17 9.20 9.21 9.34 10.0 10.1
Contents
10.7 10.10 10.18 10.26 10.42 10.47 10.59 10.63 10.71 10.79
Organisation Preparation of a maintenance contract General work procedures Competency of contractors staff Test equipment Services Method statement Records Emergency call-out procedures Responsibilities of the trust to monitor the service 10.86 Preparation of a PPM schedule 10.93 Specific maintenance checks 10.109 Medical vacuum systems: bacterial filters standard operating procedure for filter changing 10.117 Schedule of maintenance services 11.0 Risk assessment control of exposure to anaesthetic agents page 66 10.1 General 10.5 Risk assessment 10.10 Methods of control 10.13 Monitoring 12.0 Definitions page 69
Appendix I General safety requirements page 73 Medical compressed air and surgical air plant Medical gas manifolds Medical vacuum plant Pipeline distribution system Warning and alarm systems Anaesthetic gas scavenging systems Yearly tasks in addition to quarterly tasks Medical compressed air plant including surgical air plant Appendix II Procedure for breaking into an existing system page 83 References page 85 Other publications in this series page 87 About NHS Estates page 88
1.0 Scope
General
1.1 This volume of Health Technical Memorandum (HTM) 2022 covers the operational management and maintenance of systems for the supply by pipeline of: a. b. c. d. e. f. g. h. medical oxygen, nitrous oxide, nitrous oxide/oxygen mixture (50% v/v), nitric oxide (currently 1000 vpm in nitrogen), medical compressed air for both respirable applications and surgical tools (at 400 kPa and 700 kPa respectively), oxygen/carbon dioxide mixture (5% CO2), medical vacuum; waste anaesthetic gas scavenging systems (AGSS).
1.2 Throughout this volume, the phrase Medical Gas Pipeline Systems (MGPS) will be used as a generic term to describe these systems. 1.3 The guidance in this volume applies to all MGPS installed in healthcare premises. 1.4 An MGPS is intended to be a safe, convenient and cost-effective alternative to the use of portable cylinders, portable compressors and portable suction units, providing gas or vacuum for clinical needs without the associated problems of porterage, noise and space wastage. 1.5 The guidance given in this volume should be followed for all new installations and refurbishment or upgrading of existing installations. 1.6 It is not necessary to apply the guidance retrospectively unless patient or staff safety would be compromised. In this case, the guidance given in this volume should be followed. 1.7 Existing installations should be assessed for compliance with this volume. A plan for upgrading the existing system should be prepared, taking account of the priority for patient safety. Managers will need to liaise with medical colleagues and take account of the latest guidance published by the Department of Health in order to assess the system for technical shortcomings. 1.8 This volume also contains details of the design equipment and operational parameters of systems which form the basis for Model Engineering Specification C11. This specification is intended for the procurement of an MGPS. As technology develops, this HTM and C11 will be revised from time-to-time, but not necessarily simultaneously. Whichever document is the most current takes precedence. 1.9 Whenever appropriate, British Standards specifications should be used.
1.0 Scope
Operational management
1.10 This volume of HTM 2022 covers such issues as statutory requirements, functional responsibilities, operational policy, operational procedures, training and communications, cylinder management, general safety, maintenance and risk assessment control of exposure to anaesthetic agents, giving definitions and working practices throughout. 1.11 This volume is intended for use by operational managers, engineers, quality controllers (QCs), technicians, finance officers and other professionals involved in the day-to-day running of an MGPS. 1.12 The primary objective of this volume is to ensure the provision of safe and reliable MGPS and their efficient operation and use. This objective will only be achieved if the medical and nursing users and estates staff participate in the introduction of an operational policy designed to minimise the hazards likely to arise from misuse of the system.
Other guidance
1.13 Guidance on provision of MGPS is given in the Health Building Notes.
2.4 Details of the quality requirements for medical gases are given in Chapter 2 of Design considerations. These requirements are summarised as follows: a. b. medical gases supplied from cylinder or liquid sources should comply with the appropriate European Pharmacopoeia (Ph Eur) monograph; medical air and pressure swing adsorber (PSA) systems should comply with the requirements given in Table 1 of Design considerations.
2.5 For oxygen systems the source of supply can be bulk liquid oxygen in a vacuum insulated evaporator (VIE), liquid or gaseous cylinders, or an oxygen concentrator (PSA) system. When cylinder supply systems are used, the source of supply comprises a primary and a secondary bank/group of cylinders which automatically change over to ensure continuity of supply. 2.6 An oxygen concentrator (PSA) system may be used to supply an oxygen pipeline system, even though the percentage concentration of oxygen is lower than that derived from liquid or gaseous sources, typically 94% or higher. 2.7 Nitric oxide, nitrous oxide, nitrous oxide/oxygen mixture and oxygen/carbon dioxide mixture supply systems are usually supplied from a medical gas manifold system, in two banks. When full, nitrous oxide cylinders contain or hold liquid and gaseous product with a liquid/gaseous boundary and they must be used upright. Nitrous oxide can also be supplied in liquid cylinders or VIEs. Nitrous oxide/oxygen mixture could also be supplied by means of nitrous oxide and oxygen mixing systems, similar to those used for the production of synthetic air. 2.8 For medical air systems for respirable use, the source of supply can be either a medical gas manifold system or a medical compressor system, or an oxygen and nitrogen mixing system (referred to as synthetic air). When air powered ventilators are used regularly, the consumption of air is high and cylinder supply systems are not recommended.
2.9 Emergency/reserve manifold systems are provided for all gases and medical air for respiratory application, except for nitric oxide. 2.10 Air or nitrogen for surgical tools is required at 700 kPa. The supply can be provided by either a small automatic manifold system or a small dedicated compressed air system. No reserve supply is required since the surgical air is not used in a life-support role. A free-standing cylinder complete with regulator should be available in the event of system failure. 2.11 A non-user adjustable pressure control unit is required to maintain pressure over the range of flows required for different tools. The control unit can be installed at the supply system or locally within the theatre control panel, be mounted separately or be incorporated into theatre multi-purpose fittings. 2.12 Medical vacuum is provided by means of a central vacuum plant. The vacuum system should always be used in conjunction with vacuum control units which include vacuum jars. In the event of inadvertent contamination of the pipeline systems resulting from vacuum jars overflowing, immediate action is required to clean the system before any fluids etc dry out. The procedure for cleaning vacuum systems is given in Chapter 6 Operational procedures. 2.13 Medical gases and vacuum are distributed throughout the hospital via the pipeline distribution system to provide gas (and vacuum) at the terminal units. Terminal units may be wall-mounted or installed within medical supply units, for example operating room fittings, bed-head trunking and walling fittings which include other facilities such as nurse-call systems, connections for patient monitoring, electrical services, audio systems, etc. 2.14 The pipeline distribution system also includes area valve service units (AVSUs). These permit isolation of certain parts of the system for servicing or repair. They are also intended for use by the user, that is a nurse or clinician, in an emergency. For example, in the event of a fire in a ward requiring patient evacuation, or system damage to the extent that serious gas loss occurred, the valve should be turned off to prevent further gas loss. 2.15 Warning and alarm systems are provided to give information to staff responsible for the operation of the MGPS, changing cylinders, responding to plant faults, and to medical staff responsible for the administration of medical gases and clinical users. It is also possible to use nitrogen for surgical power tools, particularly when nitrogen is available on the site for the production of synthetic air
Statutory requirements
3.1 It is the responsibility of the owners and occupiers of premises, general managers and chief executives, to ensure that their premises and the activities carried out within them comply with all statutes. The following are the most important statutory requirements relevant to MGPS: a. b. Health and Safety at Work etc Act 1974 (SI 1039: 1978); Health and Safety at Work Northern Ireland Order 1978; Management of Health and Safety at Work Regulations 1992 (SI 1992/2051); SR 459: 1992 Management of Health and Safety at Work Regulations (Northern Ireland) 1992; Workplace (Health, Safety and Welfare) Regulations 1992 (SI 1992/3004); Workplace (Health, Safety and Welfare) Regulations (Northern Ireland) 1993 (SI (NI) 1993/87); Provision and Use of Work Equipment Regulations 1992 (SI 1992/2932); Provision and Use of Work Equipment Regulations (Northern Ireland) 1992 (SI (NI) 19/1993); Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (SI 3163: 1985); SR 247: 1996 Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (Northern Ireland) 1986; Control of Substances Hazardous to Health (COSHH) Regulations 1994 (SI 3246: 1994); SR 374Control of Substances Hazardous to Health (COSHH) Regulations (NI) 1990; Control of Substances Hazardous to Health (COSHH) Regulations Amendment (NI) 1992, (SI41: 1993); Pressure Systems and Transportable Gas Containers Regulations 1989 (SI 1989 No 2169); SI 471: 1991 Pressure Systems and Transportable Gas Containers Regulations 1991; Highly Flammable Liquid and Liquefied Petroleum Gases Regulations (SI 1972 No 917); Highly Flammable Liquid and Liquefied Petroleum Gases Regulations (NI) 1975 (SR 256); Medicines Act 1968 (this applies in NI); Manual Handling Operations Regulations 1992 (SI 1992/2793); Manual Handling Operations Regulations (Northern Ireland) 1992 SI (NI) 535/1992;
c.
d.
e.
f.
g.
h.
j. k.
m. Personal Protective Equipment at Work Regulations 1992 (SI 1992/3139); Personal Protective Equipment at Work Regulations (Northern Ireland) 1993 (SI 1993); n. p. Electrical Equipment (Safety) Regulations 1994, SI 3260; Electromagnetic Compatibility Regulations 1992 (SI 1992/2372).
is not the only source of risk; the temperature and other factors should also be taken into account, for example, cryogenic liquid containers. 3.9 Management is responsible for assessing all the risks to avoid injury.
COSHH Regulations
3.12 These regulations apply to substances that have been classified as being very toxic, toxic, harmful, corrosive or irritant. Specific duties are placed upon employers and employees in relation to these substances. 3.13 The specific responsibilities for employers include assessment, protection and control, monitoring, health surveillance and information and training. 3.14 The COSHH regulations apply to MGPS in that inhalation anaesthetic agents and Nitric Oxide (NO) are substances to which Occupational Exposure Standards (OESs) have being assigned. 3.15 It is the managers responsibility to ensure that a proper system of assessment, protection and monitoring is implemented in order to comply with the regulations. The guidance given in Chapter 11 Risk assessment control of exposure to anaesthetic agents and the Design considerations volume of this HTM in respect of anaesthetic gas scavenging systems (AGSS) should be implemented as a matter of priority. OESs for nitrous oxide, enflurane, halothane and isoflurane came into effect on 1 January 1995. The current issue of EH40 should be consulted.
10
3.18 The regulations define and extend the role of a competent person. The competent person is required to draw up or to certify a written scheme of examination. This should cover the whole system, not merely the pressure vessels. The term competent person has been used in this HTM to refer to the fitter who carries out the installation or modification to the MGPS. For the purposes of clarity, this person (fitter) is referred to as the competent person (MGPS). This is not the same person referred to as a competent person for the purposes of the regulations, who is normally a chartered engineer with specialist expertise and experience, although in certain cases an incorporated engineer may carry out the duties of a competent person. 3.19 A written scheme of examination as specified by the Pressure Systems and Transportable Gas Containers Regulations 1989 should be drawn up for all MGPS. For new installations the consulting engineers may prepare the written scheme. An appropriate competent person should implement the written scheme and carry out the examinations required. For pressure vessels, this would normally be carried out by an appropriate insurance company with specialist expertise in this field. 3.20 Requirements for pressure vessels are included in these regulations.
Medicines Act
3.23 Medical gases are classified as medicinal products under the Medicines Act and are therefore subject to the same procurement and quality procedures as all other medicinal products. 3.24 The quality controller (QC) is responsible for quality control of all medicinal products and this will include medical gases. 3.25 Medical gases and vacuum should not be used for non-medical purposes other than as a power source for medical equipment and also for testing medical equipment.
11
General
4.1 Since the first edition of this HTM, there have been profound changes in the management philosophy of the NHS. Many hospitals have become selfgoverning trusts, many general practices have become fund-holders, and there is a trend towards deregulation and contracting-out of services. 4.2 The approach chosen for this HTM is to identify the distinct functions that need to be exercised and the responsibilities that go with them. The titles given here are therefore generic. They describe the individuals role in connection with MGPS, but are not intended to be prescriptive job titles for terms of employment. Indeed, some of the personnel referred to may not be resident staff but people employed by outside bodies and working on contract, for example competent persons (MGPS). 4.3 Some staff will have other responsibilities unconnected with MGPS and in some cases the same individual may take on more than one role. 4.4 In all cases, however, it is essential to identify an authorised person who is responsible for the day-to-day management of the MGPS. 4.5 The philosophy of this HTM is to invest the authorised person (MGPS) with the responsibility for seeing that the MGPS is operated safely and efficiently. Only the authorised person (MGPS) can decide whether an MGPS should be taken into or out of use. In order to avoid confusion with other authorised persons, such as the authorised person for high voltage installations, the authorised person for the MGPS will be referred to as the authorised person (MGPS) throughout this HTM. Previous editions of HTM 22 defined a responsible officer. As a result of the changes to the management structure within the NHS, the duties of the responsible officer are now carried out by the chief executive, estates manager or the authorised person (MGPS) as appropriate. It is therefore considered that the role of the responsible officer is no longer required.
Management
4.6 Management is defined as the owner, occupier, employer, general manager, chief executive, or other person (MGPS) who is ultimately accountable for the safe operation of the premises.
Key personnel
4.7 The following are the key personnel who have specific responsibilities within the operational policy: a. b. c. d. e. f. executive manager; estates manager; authorised person (MGPS); competent person (MGPS); quality controller (QC); designated medical or nursing officer.
12
Executive manager
4.8 The executive manager is defined as the person with ultimate management responsibility, including allocation of resources and the appointment of personnel, for the organisation in which the MGPS are installed. 4.9 Depending on the nature of the organisation, this role may be filled by the general manager, chief executive, laboratory director or other person of similar authority. 4.10 The formal responsibility for the MGPS rests with an executive manager, although the authorised person (MGPS) retains effective responsibility for day-to-day management of the MGPS. 4.11 The executive manager is responsible for the implementation of the operational policy for the MGPS. He/she should ensure that the operational policy clearly defines the roles and responsibilities of all personnel who may be involved in the use, installation and maintenance of the MGPS. The executive manager is also responsible for monitoring the implementation of the policy. 4.12 The executive manager may delegate specific responsibilities to key personnel; the extent of such delegation should be clearly set out in the operational policy, together with the arrangements for liaison and monitoring.
Estates management
4.13 The estates management includes responsibility for the integrity of the MGPS. There may be one or more authorised and competent persons (MGPS) with clear line management responsibility. 4.14 Estates management should include monitoring the implementation of the operational policy for MGPS. In particular, the MGPS should comply with the requirements of this HTM and all work should be carried out in accordance, where possible, with the permit-to-work procedures.
13
4.18 Procedures using permits for the authorisation of work requires the fullest co-operation of all staff and their acceptance of the responsibilities involved. The authorised person (MGPS) should take the lead in co-ordinating the work and explaining fully the extent and duration of any disruption to the service. He/she should also ensure that all contractors follow the procedures set out in the permit. 4.19 a. b. The authorised person (MGPS) is responsible for ensuring that: all designated nursing officers likely to be involved are advised of the estimated duration of the work and the interruption to the MGPS; all terminal units affected, that is, out of service, are appropriately labelled.
4.20 On a large site, there could be several authorised persons (MGPS). In this case, the executive manager should appoint one as the senior authorised person (MGPS) with overall responsibility for the site. In any case, arrangements should be made to ensure that an authorised person (MGPS) is always available during holidays and other absences of the other authorised person(s) (MGPS). 4.21 The authorised person (MGPS) is required to liaise closely with other professionals in various disciplines, and consequently the appointment should be made known in writing to all interested parties. He/she should have direct contact with the quality controller (QC), users and other key personnel. 4.22 The authorised person (MGPS) is responsible for assessing the competency of all competent persons (MGPS) employed directly by the estates department and maintaining a list of registered competent persons (MGPS). 4.23 The authorised person (MGPS) is responsible for ensuring that work is carried out only by approved specialist contractors registered to BS EN ISO 9000 with scope of registration defined as design, installation, commissioning and maintenance of MGPS as appropriate. Evidence of current registration should be by sight of the correct certificate of registration. The concept of the existing Quality Assurance BSI Schedule QAS 3720.1/206 is currently under review. Further guidance will be given when appropriate.
14
15
General
5.1 The executive manager is responsible for the overall operational policy and its implementation. 5.2 The Chapter headings given in this volume of HTM 2022 and subsequent Chapter guidance should enable an operational policy to be prepared. Separate policies or procedures are sometimes prepared to supplement the operational policy. It is acknowledged that some trusts have separate procedures that are referenced within the operational policy under the control of specific departments, that is, cylinder management under the control of the pharmacy department.
Operational considerations
5.3 The operational policy should ensure that users are aware of the capacity of the system and any particular limitations, for example a 400 kPa medical air system supplied from a cylinder manifold system is unlikely to sustain the use of a number of respiratory ventilators. Nursing and medical staff should also be aware of the purpose of alarm systems and of the course of action to be taken in the event of an emergency alarm occurring. They should be similarly familiar with the purpose of area value service units (AVSUs) and how to use them in an emergency. 5.4 MGPS provide gases at terminal units of a microbiological quality which is adequate for virtually all applications. There may be exceptional circumstances, for example patients receiving immuno-suppressive drugs, where additional precautions may be required. This can be most readily achieved by incorporating an appropriate bacteria retentive filter in the breathing system. Similarly, changes in patient ventilation regimes can affect the capacity of systems. For example, continuous positive airway pressure (CPAP) ventilation can lead to significant consumption of oxygen. 5.5 Medical gases should not be used for non-medical purposes other than as a test gas for medical equipment; except under specific circumstances as defined in paragraph 2.6 of Design considerations. 5.6 Medical air should be used as the power source for medical equipment such as ventilators or venturis; oxygen should not be used, except in an emergency where an appropriate medical air system is not available. The routine use of oxygen as a driving gas is to be avoided. 5.7 Medical gases supplied from cylinder or liquid sources comply with the European Pharmacopoeia (Ph Eur). Pressure swing adsorber (PSA) systems comply with the requirements given in Chapter 6 of Design considerations. All other gases or medical gas mixtures will comply with the product licence specification held by the gas supplier. 5.8 Where PSA systems are installed, medical staff will need to take account of the reduced oxygen concentration when using medical equipment, and be aware of possible increases in concentration if the emergency/reserve manifold is in operation. 16
5.9 Staff responsible for plant operation should be aware of the activities necessary to ensure the continued safe operation of the system and what action should be taken in an emergency. The authorised person (MGPS) in particular should take a lead in explaining to users the function of the system and will have to be adequately trained and informed about the system. (See also paragraphs 7.17.7, on training.) 5.10 Where gas blenders are used at point of use, for example with patient ventilators, the manufacturers instructions should be followed with regard to operation and maintenance, to prevent contamination of a pipeline in the event of equipment malfunction. Further details are given in Chapter 10 Maintenance. BS ISO 11195 1995 Gas mixers for medical use stand-alone gas mixers was developed to avoid this problem. 5.11 Some older types of blending equipment can allow back flow from one pipeline to another, for example leading to oxygen enrichment of medical air systems, or reduction of oxygen content in oxygen pipelines. When not in use, blenders should be disconnected. 5.12 There is growing interest in the concept of mixing liquid oxygen and liquid nitrogen on-site for the provision of medical synthetic air. This system is not yet developed in the UK healthcare market, but is currently in use in the USA. Given the concerns about inner city pollution, this concept may offer considerable advantages over conventional compressor systems. 5.13 In some hospital ward areas medical gas equipment is installed within enclosures or behind decorative panels to provide a more domestic environment. In these cases it is essential that identification is maintained so that staff are aware that equipment is available for patient use. Staff should also ensure that gas supplies are turned off, blenders are disconnected and suction jars removed and cleaned before any equipment is concealed. 5.14 Users of 700 kPa surgical systems should be aware of the stored energy of gas in the connecting assembly (hose) and should take care to avoid the hazard of rapid ejection of probes when disconnecting tools. 5.15 Portable suction units should be used in areas where there is a possibility that the vacuum system could become contaminated. Such areas would include infectious diseases units. The need for portable suction units should be discussed with the control of infection officer. 5.16 Before any maintenance work is carried out on any medical equipment, including portable suction units, the equipment should be appropriately decontaminated and the procedures in Appendix II should be followed. 5.17 Any work involving alterations, extensions or maintenance work on the system should be subject to the permit-to-work procedure set out in Chapter 6 Operational procedures, which should be under the control of the authorised person (MGPS). 5.18 The responsibility for gas cylinders should be clearly defined in the operational policy. This would include the training of personnel in the correct procedures for cylinder handling, storage and transportation. The procedures in Chapter 8 Cylinder management should be followed. 5.19 Pharmacy staff have a responsibility for monitoring the quality of all gases delivered, including PSA, compressed air and synthetic air. It may be appropriate to include warning systems within the pharmacy department.
17
Emergency procedures
5.20 The operational policy should set out the procedures to be followed in the event of an emergency. This should include the following: a. b. c. d. reporting an incident; action to be taken, for example turning off isolation valves, use of portable emergency cylinders; liaison with other staff and departments; calling out contractors.
5.21 All alarm systems should be clearly labelled and all staff should be trained in the appropriate action to be taken in the event that an alarm is initiated.
Record drawings
5.23 The estates department should have accurate and up-to-date drawings of the MGPS showing main sections and branches, departments served, control valves, terminal units and alarm systems for each medical gas service. These drawings should be readily available on site for use by any authorised person (MGPS). Their location should be known by all authorised persons (MGPS). Each isolating valve should be individually identified by a unique reference number. The appropriate reference number, corresponding to that shown on the drawings, should be displayed at or on each isolating valve. The drawing should indicate the type and make of terminal units. 5.24 A schematic diagram of the installation is usually helpful. Up-to-date drawings and records are required under the Pressure Systems and Transportable Gas Containers Regulations 1989
5.25 When additions or alterations are to be made to existing installations by a contractor, the authorised person (MGPS) should provide an adequate number of prints from the master drawing as agreed with the contractor. On completion of the work, the contractor should return to the authorised person (MGPS) at least one copy of an amended print, indicating pipework alterations etc. The authorised person (MGPS) should arrange for the master MGPS drawing to be updated. In some cases it may be part of the contract agreement that an amended as fitted drawing is provided by the contractor to then replace the original master drawing.
the locking system should be capable of being overridden. Medical gas plantrooms should be kept locked, except when work is actually in progress in them. 5.27 plantrooms containing medical gas cylinders should be kept locked, with a prominently-displayed notice indicating the location of the spare key. 5.28 For access in the event of an emergency see paragraph 8.89.
5.29 The valves in the liquid oxygen installation need not be kept locked. The gate to the liquid oxygen installation should be kept locked and an indestructible and clear notice stating the location of the key should be securely fixed to each gate of the installation. The fire brigade should be informed of the location of the key (see paragraphs 8.868.88). 5.30 The procedure in the operational policy for keeping keys should be followed.
Contractors
5.33 All contractors should comply with the trust or hospital safety policy. This should be clearly stated in the operational policy. The concept of the existing Quality Assurance BSI Schedule, QAS 3720.1/206.1A is currently under review. Further guidance will be given when appropriate. 5.34 Work on MGPS should only be carried out by specialist firms registered to BS EN ISO 9000 with scope of registration defined as design, installation, commissioning and maintenance of MGPS as appropriate. Evidence of current registration should be by sight of the correct certificate of registration. 5.35 The operational policy should set out the responsibilities for monitoring the work of contractors. This would normally be co-ordinated by the authorised person (MGPS). The procedures for calling out a contractor, particularly in the event of a fault or an emergency, should be set out in the operational policy.
19
such as patient ventilators, is connected to the medical air 400 kPa system, to ensure that the system capacity is not exceeded. Certain ventilators can also have a significant effect on the capacity of oxygen systems, particularly those operating under continuous positive airway pressure (CPAP). 5.37 The policy should state the procedures to be followed and the personnel who need to be consulted before a new item of medical equipment is connected to the MGPS.
20
Permit-to-work procedure
Introduction 6.1 Safety rules and procedures for MGPS are necessary to ensure that the integrity and performance of the system is maintained. 6.2 The purpose of the permit issued under this permit-to-work system is to safeguard the integrity of the MGPS. It is not intended as a permit to protect the safety of staff. In some cases there may be additional safety procedures to be followed under the Health and Safety at Work etc Act 1974 or the health authoritys safety policy or COSHH. 6.3 A permit-to-work should always be issued before any work is carried out on the MGPS. The purpose of such a permit is to identify the work to be carried out and to provide documentary evidence that a system is only taken back into use when all tests have been satisfactorily completed. 6.4 The permit-to-work procedure is one of the responsibilities of the estates department. The authorised person (MGPS) who has day-to-day responsibility for the MGPS will be responsible for the implementation of the permit-to-work procedure. Scope General 6.5 The permit-to-work procedure is applicable to the servicing, repair, alteration and extension of existing MGPS within a hospital, and any action, such as the closure of an isolating valve, which restricts the supply. This means that permits should also be used before any major item of central plant, for example manifold, control panel, compressor, or vacuum pump (including any stand-by plant), is isolated prior to servicing, repair or overhaul. A specimen permit form is given in Figure 2. 6.6 The permit will remain in force until the work is completed and the MGPS is taken back into use, in accordance with the procedure. Emergencies 6.7 In the event of an emergency such as a fire or a major leak, a doctor or nurse should isolate the affected section by closing the emergency isolating valves or area valve service units (AVSUs). He/she should notify the authorised person (MGPS) as soon as possible. 6.8 The emergency procedure set out in the hospital authoritys operational policy should be followed.
21
Work by contractors 6.9 Permits should be issued to any of a contractors competent staff and artisans who are to be engaged in work on the MGPS. Contracts should be placed only with firms who are appropriately registered as discussed in paragraphs 4.23 and 5.34. Further guidance on contractors competence etc is given in the Preparation of a maintenance contract section of Chapter 10 Maintenance. 6.10 Neither the department nor the health authority should be expected to test the competence of the contractors staff. The contractor should maintain a register of competent persons. Routine changing of cylinders 6.11 Permits are not necessary for the routine replacement of cylinders on manifolds nor for the recharging of vacuum insulated evaporators (VIEs), provided there is no danger of the supply being disrupted when these tasks are undertaken. Planned preventative maintenance (PPM) work Where visual inspections have been carried out historically and will continue to be carried out by the trusts in-house staff, existing documentary evidence of work completion may be an alternative to the permit as agreed with the authorised person (MGPS). 6.12 A permit should be issued for all PPM work on the MGPS. This includes all examinations where no interruption to the service is anticipated. Levels of hazard 6.13 Whenever work is to be carried out on the MGPS, it is assigned a level of hazard dependent upon the nature of the work. The authorised person (MGPS) assesses the hazard level at the time of preparing the permit and if in doubt he/she will assess the hazard at the higher level. The higher the hazard the greater the care required in the re-commissioning procedure. Three levels of hazard are defined as follows: a. high hazard work: work on any part of the MGPS that requires cutting or brazing. Cross-connection, performance, identity and quality tests will be required before the MGPS is taken back into use; medium hazard work: work on two or more adjacent terminal units (excluding vacuum) which do not comply with BS 5682. Performance and identity tests will be required before the MGPS is taken back into use; low hazard work: work on terminal unit (in addition to vacuum) which comply with BS 5682. A performance test only will be required before MGPS is taken back into use.
b.
c.
6.14 Terminal units which comply with BS 5682 comprise components which are gas-specific and it is therefore not possible to miss-assemble the terminal unit in such a way that the wrong gas is delivered. This is the principle on which the levels of hazard are based.
23
6.15 The gas-specific feature can be achieved by means of indexing pins, gas-specific shapes etc. During reassembly the gas-specific features should be checked to ensure they have not been damaged. 6.16 Terminal units complying with BS 5682 include an automatic isolating valve and some earlier terminal units include a manual valve. 6.17 When working on individual terminal units fitted with an integral isolating valve or check valve (which operates when the socket assembly is removed), it is not necessary to interrupt the supply to other adjacent terminal units. 6.18 Terminal unit termination blocks should not be left unattended with the socket currently removed unless a blocking plate has been attached. 6.19 Outlets which have been disconnected from their supply (cut and capped supplies) should be removed or fitted with full disc-size prohibition labels. Long runs which may hold stagnant gas and cannot be purged should be avoided. Duties 6.20 A summary of the duties and responsibilities of personnel involved is given in Chapter 4 Functional responsibilities. Permission for interruption or restriction of supply 6.21 Permission should be obtained before work is carried out to allow designated medical or nursing officers adequate time to move patients etc, except in an emergency. 6.22 The authorised person (MGPS) should describe to the designated medical or nursing officer the extent to which the MGPS will be restricted or interrupted while the work is in progress and should indicate the level of hazard involved. He/she should obtain agreement for this restriction or interruption by means of a signature on Part 1 of the permit. He/she should also assist as necessary, to ensure that a service is maintained whilst the MGPS is disrupted. Liaison with medical and nursing officers and quality controller 6.23 The procedures allow work to proceed on an MGPS only with the knowledge of the QC (for high hazard work only), and the permission of either the designated medical or nursing officer would be competent to grant permission in all cases where the authorised person (MPGS) indicates in Part 1 of the permit-to-work that the work is of a low hazard nature. No work of a high hazard nature should normally be permitted without the permission of the designated medical officer. 6.24 The permission of the designated medical officer should normally be obtained before any interruption is caused to the supply of a gas affecting more than one ward or department of a hospital. This approval may be given by a designated nursing officer in circumstances to be agreed locally and subject to periodic review by those concerned. These agreements should be recorded in the operational policy, as described in Chapter 5 Operational policy.
When terminal units to BS 5682 are dismantled for repair or replacement of the main working components it is not possible to re-assemble them with parts designed for another gas service, except by a wilful act on the part of the fitter, for example by cutting or removing non-interchangeability keys. It is thus not possible to supply gas to a patient by inserting a probe into the incorrect terminal unit, for example an assembly comprising an oxygen pipe termination block and a nitrous oxide outlet. Parts can become damaged or omitted during assembly and continuing vigilance is required. Some early terminal units not complying with BS 5682 do not include service isolating or check valves.
24
6.25 There should be general agreement between the authorised person (MGPS), and the medical and nursing officers on the length of advance notice which will normally be required before interruptions of the MGPS may be made. This might typically be 48 hours for fully pre-planned work. These agreements should be recorded in the operational policy. Isolation of plant and pipeline system 6.26 The authorised person (MGPS) is responsible for witnessing the isolation and for making safe the plant or system to be worked on. 6.27 No section of an MGPS should be worked on, or pressure tested, unless it is adequately isolated from any section in use or available for use. 6.28 Physical isolation, by means of a break point at the supply end of the section to be worked on, is essential, except in the case of work on terminal units only. An AVSU may be used for this purpose, as described in Design considerations. The procedure for installing an additional branch is given in Appendix II. Limits of authorisation 6.29 There should be no commencement of work on any MGPS until the designated medical officer or designated nursing officer has given written permission, on the permit, for the work to take place. 6.30 Permits should only be issued immediately before work is to start and they should only be issued to a competent person (MGPS). 6.31 The permit should provide concise and accurate information about when and where it is safe and when and where it is dangerous to work. It should provide a clear statement of the work to be done. The estimated time for completion should also be given, but this is for guidance purposes only, and should not prejudice the completion of the work in complete safety. 6.32 The scope of the actual work done should be limited to that described in Part 2 of the permit and no one should change the description of the work. In the event of a change in the programme of work, the permit should be cancelled and a new one issued. This should be cross-referenced to the original Part 1 approval. If the change is no longer covered by Part 1 approval, a completely new permit should be initiated. 6.33 A competent person (MGPS) accepting a permit is, from that moment, responsible for the safe conduct of the work within the limits of the permit, but the work will be subject to the usual supervision by the authorised person (MGPS) and proper commissioning procedure on completion. The competent person (MGPS) should not allow himself/herself to be persuaded into breaking the conditions of the permit. He/she should make himself/herself fully conversant with its terms and requirements, and should give sufficient and clear instructions to persons working under him/her. Scope of permit 6.34 The extent of the work specified in Part 2 of the permit should not be amended. If changes to the work are required, a new permit should be issued.
25
6.35 6.36
Any errors may be corrected and initialled. The permit remains in force until Part 8 is completed.
Permit issuing authority and control of permit books 6.37 The issuing authority should be the authorised person (MGPS). Permits may only be issued by an authorised person (MGPS). 6.38 A new book of permits should not be taken into use until the old book is completely used and accounted for. 6.39 The permits should be consecutively numbered.
Forms of permit 6.40 The permit is to be in book form, numbered consecutively, with two coloured tear-out copies for use as follows: a. b. c. copy 1 to the competent person (MGPS); copy 2 to the QC; original retained in book, which remains with the senior authorised person (MGPS) for the site. Additional photocopies should be taken for contractors.
Responsibilities of the authorised person (MGPS) for the permit-towork procedure 6.41 a. b. c. d. e. f. g. h. j. k. The responsibilities of the authorised person (MGPS) are as follows: obtaining permission for interruption of supplies and affixing do not use or other prohibition notices; preparing permit; supervising isolation of section on which work is to be carried out; explaining details of work to competent person (MGPS); supplying drawings of existing sections of the installation as fitted; supervising performance, cross-connection and identity tests of completed work as appropriate; supervising purging with working gas; final testing, assisted by the QC in the case of high hazard work; final testing in the case of low and medium hazard work; restoring service;
m. supervising or making final connection of any extension; n. p. q. r. s. notifying designated medical officer or designated nursing officer of completion of work and removal of do not use notices; obtaining corrected copy of drawings; supervising amendments of office copy of as-fitted drawings; retaining original copy of permit and all permit books; obtaining designated medical or nursing officers signature on Part 8 and return the system to service.
26
Responsibilities of the competent person (MGPS) for the permit-towork procedure 6.42 a. b. c. d. e. f. The responsibilities of the competent person (MGPS) are as follows: signing Part 3 of the permit, acknowledging responsibility for the work; obtaining and understanding instructions on work to be done; isolating section of system on which work is to be carried out, under direct supervision of authorised person (MGPS); carrying out the work; carrying out system integrity tests on completed work under direct supervision of authorised person (MGPS); signing Part 4 on both the original permit (held by the authorised person (MGPS)) and the copy 1 declaring that the work is completed as indicated on the permit.
Responsibilities of the designated medical and nursing officers 6.43 The responsibilities of the designated medical and nursing officers are as follows: a. b. c. d. signing Part 1 of the permit to agree that the system can be taken out of use for servicing or maintenance; advising other clinical staff that the system is not available for use; on completion of the work, signing Part 8 of both the original and copy of the permit accepting the system back into use; advising clinical colleagues and departmental heads that the system is available for use.
Responsibilities of the quality controller (QC) 6.44 The QC is involved in testing after high hazard work only. The responsibilities of the QC are as follows: a. b. c. identify the test equipment required, depending upon the specific service which has been disrupted; carry out final identity and quality tests on the systems; sign Part 7 of the original permit (held by the authorised person (MGPS)) and copy 2 declaring that the testing is completed as indicated on the permit.
Preparation and issue of permit-to-work 6.45 The authorised person (MGPS) should prepare Part 2 of the permit. He/she should identify, from the MGPS drawings, the work to be done and the means of isolation, unless the work to be done is of a low hazard nature. 6.46 Except in the case of low hazard work, he/she should normally re-check the permit whilst looking at the actual installation to make sure that the possibility of unexpected cross-connections has been carefully considered. He/she should give a brief summary of the work and information on other relevant permits which are in force. If work is to be carried out only on terminal units which incorporate integral isolating valves, he/she should enter
27
in the isolation space on the permit: terminal units have integral isolating valves. The authorised person (MGPS) should affix do not use or other prohibition notices to terminal units and plant as appropriate. 6.47 Wherever possible drawing reference numbers should be identified on the permit. A copy of the relevant drawing should be attached to the permit. 6.48 The competent person (MGPS) should read the permit, question anything that he/she does not understand and then sign Part 3, to certify that he/she has read and understood it. 6.49 Copy 1 should then be placed in a protective cover and given to the competent person (MGPS). The original and copy 2 should remain in the book. 6.50 The authorised person (MGPS) should ensure that the competent person (MGPS) is aware of the need for fire and other safety precautions, particularly if any brazing is to be carried out, and that permits-to-work which may be required for safety reasons, for example work in confined spaces, have been issued. Action on completion of work 6.51 The competent person (MGPS) should sign Part 4 of the original permit, to certify that work has been completed, and call the authorised person (MGPS) to examine and test the installation. The competent person (MGPS) should also sign Part 4 of copy 1 of the permit for his/her records. 6.52 The authorised person (MGPS) should satisfy himself/herself that the work has been satisfactorily completed and should supervise the testing of valve tightness, pressure, cross-connection, flow rate and delivery pressure, and of the alarm system, in accordance with the recommendations of Design considerations. 6.53 On satisfactory completion of all tests, the authorised person (MGPS) should supervise the reconnection of the isolated system to the main system and purge with the working gas. 6.54 The authorised person (MGPS) should then complete Part 5 of the permit on the original permit. 6.55 In the case of low and medium hazard work, the authorised person (MGPS) should complete Part 6 of the permit, when satisfied that the system may be taken into use. 6.56 For high hazard work, the authorised person (MGPS) and the QC should complete Part 7 of the permit, when satisfied that the MGPS may be taken into use. 6.57 In the case of high hazard work, the authorised persons (MGPS) should invite the QC to assist him/her in carrying out the identity and quality tests and accepting the MGPS for use. 6.58 Copy 2 should be given to the QC.
6.59 The authorised person (MGPS) should inform the designated medical or nursing officer that the work is completed and that the MGPS is now available for use, and the designated medical or nursing officer should sign Part 8, accepting the pipeline back into service.
28
6.60 The authorised person (MGPS) should remove any do not use or other prohibition notices. The authorised person (MGPS) should retain the book with the completed original permit.
6.62 The actual tests required depend on the level of hazard of the work which has been carried out. 6.63 Full details of the tests, test equipment, procedure and responsibilities are given in Design considerations. The test requirements are summarised below for completeness. Cross-connection tests 6.64 Following any work which involves cutting or brazing, each system in turn, including vacuum, should be checked to ensure that there is no crossconnection between pipelines for different gases and vacuum. 6.65 Cross-connection tests must not commence until all installations are complete and all AVSUs must be open. The system under test must be at pipeline distribution pressure, and all other systems must be at atmosphere pressure. In critical areas, it is recommended that there are at least two AVSUs serving each area. Where pendants are installed, these may be pneumatically controlled using medical air. In this case, both the terminal units in the pendant and the pneumatic function may be connected with three separate noninterchangeable screw thread (NIST) connectors, and supplied from two different AVSUs. Although it would not be possible to connect the wrong gas during the crossconnection tests, a check should be made to ensure that the correct AVSU is controlling the correct NISTs. 6.66 The test involves carrying out a check of all terminal units which may have been affected by the work, to ensure that gas flows from every terminal unit of the system under test, but that there is no gas flow from any other terminal unit. Performance tests 6.67 Performance tests include tests at each terminal unit to ensure that the correct flow is delivered at the specified pressure and tests to demonstrate the correct operation of the warning and alarm systems. Identity 6.68 The identity of the gas must be tested at every terminal unit which may have been affected by the work, and the composition of all compressed gases must be positively identified.
29
6.69 An oxygen analyser is used for O2 and O2/N2O mixture and medical and surgical air. A nitrous oxide analyser is used for N2O. The requirements are given in Design considerations. Quality 6.70 The quality of the gas must be tested at every terminal unit which may have been affected by the work. The objective of the tests is to establish whether the pipeline has been contaminated during the work. Monitoring and test equipment 6.71 All monitoring and test equipment used for MGPS should be purchased to the appropriate quality standard and instrumentation should be calibrated in accordance with NAMAS Standards.
b. c.
d.
e. f. g.
30
h.
aspirate about litre of solution through the next ten or so downstream terminal units and connect a vacuum control unit to each and adjust as in (f); check other downstream terminal units for presence of solution. Where such evidence is found, repeat (h); repeat (f) to (j) using clean hot water. Note: at this stage the system can be taken back into clinical use;
j. k.
m. leave the system running and check the plant for evidence of fluid in the filter sight glasses; n. p. where fluid is present, change the bacterial filters in accordance with paragraphs 10.11310.116; monitor the system over the next few days, with the vacuum control units connected, for presence of liquid in the system. (The system will eventually dry out as the liquid vapour pressure equilibrates to the vacuum in the pipeline, but this may take several days.)
31
Training
7.1 It is essential that personnel at all levels have a sound general knowledge of the principles, design and functions of MGPS. They should be trained on those specific systems for which they will be responsible. 7.2 A training programme should be established for all staff responsible for MGPS. All training should be recorded and reviewed regularly. 7.3 All authorised and competent persons (MGPS) should have satisfactorily completed an appropriate training course before they are appointed. Suitable courses are run by specialist consultants and by specialist companies. 7.4 Satisfactory completion of an appropriate training course is not in itself sufficient for appointment as an authorised or competent person (MGPS). All staff should have sufficient experience and be familiar with their particular installations before they can be appointed as authorised or competent persons (MGPS). 7.5 All authorised persons (MGPS) should be re-assessed every three years and should have attended a refresher or other training course prior to such reassessment. The recommendation for appointment or re-appointment as an authorised person (MGPS) should be made by a chartered engineer who has specialist knowledge of MGPS. 7.6 The QC should also receive specific training covering the responsibilities and duties which he/she will be required to carry out. It may be appropriate for the QC to attend part or all of the training courses for authorised persons (MGPS). 7.7 The medical and nursing staff who use the MGPS should be trained in the use of the system. This training should include the practical use of the system, emergency and safety procedures. This is particularly relevant to the designated medical and nursing officers, who may need to receive more detailed training in specific areas such as emergency procedures. The executive manager should ensure that all staff have received this training prior to using the MGPS and that refresher courses are arranged at least annually.
Communications
7.8 All staff who are involved in the use, installation or maintenance of MGPS should be aware of the operational policy and their specific responsibilities. 7.9 The operational policy should set out the means of communications between the various key personnel. It should, for example, define those departments which need to be informed of work on the MGPS, the personnel to be notified and whether such information is to be verbal or in writing. 7.10 The action to be taken in the event of a fault should be set out with a clear means of reporting the fault to the estates management.
32
8.6 The decanting and filling of medical gas cylinders is subject to the Pressure Systems and Transportable Gas Containers Regulations 1989 and the Health and Safety at Work etc Act 1974. Unless the healthcare organisation has a relevant manufacturers licence and product licence, and can demonstrate compliance with the Pressure Systems and Transportable Gas Containers Regulations1989, these activities should not be carried out under any circumstances. Decanting is not recommended, but if absolutely unavoidable, and the above criteria can be met, the advice of the gas supplier should be sought and implemented. Classification of gas cylinders 8.7 In this document, gas cylinders are classified into two main categories medical and non-medical. Cylinders from these two categories must never be mixed, either in storage or in use. 8.8 Gas cylinders are subdivided into groups, depending on the major risk associated with the cylinder contents as follows: a. b. c. d. Group 1 flammable; Group 2 oxidising; Group 3 toxic or corrosive (the contents may also be flammable or oxidising); Group 4 others (including inert gases).
33
The most common gases, grouped as above, likely to be used in health buildings are shown in the table below. Table 1 Classification of gas cylinders Group classification of gas cylinder contents 1 Flammable (Red diamond on label) Medical gases Non-medical gases
acetylene; LPG (eg propane, butane); STG (synthetic town gas) methane, natural gas; hydrogen oxygen; nitrous oxide oxygen/nitrous oxide oxygen/carbon dioxide oxygen/helium mixtures oxygen nitrous oxide oxygen/nitrous oxide mixtures
2 Oxidising and/or supports combustion (Yellow diamond on label) 3 Toxic and corrosive 3.1 Toxic and/or corrosive and flammable
ammonia; ethylene oxide (C2H4O); carbon monoxide; C2H4O/CO2 mixtures; >6% C2H4O nitric oxide mixtures; sulphur dioxide; chlorine ethylene oxide/halo-carbon mixtures <15% C2H4O); certain conditions only ethylene oxide/carbon dioxide mixtures <6% C2H4O carbon dioxide; helium; medical air; nitric oxide; 1000 vpm in nitrogen compressed air; carbon dioxide; nitrogen; argon; helium; halocarbon; refrigerants
3.2 Toxic and/or corrosive and oxidising 3.3 Toxic and/or corrosive only
4 Others including inert, but excluding toxic or corrosive (Green diamond on label)
Safety main principles 8.9 a. The main hazards associated with gas cylinders are: careless storage, handling, dropping or impact can cause physical or personal injury. These hazards should be minimised: (i) by the correct design, siting and construction of cylinder storage areas, (ii) by the provision of suitable storage and handling equipment; and (iii) by the adoption of safe operating practices; b. leakage of gas where the cylinder contents may be flammable, oxidising, asphyxiant, anaesthetic, toxic or a combination of these characteristics. In the event of leakage, gas may collect in a confined space and cause or contribute to a fire, explosion or health hazard.
34
d.
e.
f. g.
35
8.17 If the travel distance from the access doors to any part of the stores exceeds 15 m, additional emergency exits should be provided. The advice of the local fire safety officer should be sought.
Hazchem/warning signs
8.18 Safety warning signs and notices should be used where appropriate and posted in prominent positions. They should be sited and designed in accordance with the requirements of SI 1980 No 1471 The Safety Signs Regulations 1980; BS 5378: Part 1: 1980, Part 3: 1982 Safety Signs and Colours; BS 5499: Part 1: 1984 Fire Safety Signs Notices and Graphic Symbols and the Health and Safety at Work etc Act 1974. Location 8.19 Cylinder stores should be located at ground level, not underground, for example in a basement. 8.20 Cylinder stores should be located as close as possible to the delivery point. Wherever possible there should be only one delivery supply point for each site. 8.21 No parking should be permitted within the delivery and storage area, other than for loading and unloading cylinders. 8.22 The location of the cylinder store should be marked clearly on the site plan for ease of identification in the event of an emergency.
Handling of cylinders
General 8.23 Cylinders can be heavy and bulky and should therefore be handled with care only by personnel who have been trained in cylinder handling and who understand the potential hazards. 8.24 A suitable trolley should be used for transporting cylinders whenever they are moved. 8.25 Cylinders should not be lifted by their guards or valves unless specifically designed for that purpose. 8.26 Cylinders should not be dropped, knocked, used as rollers or be permitted to strike each other violently. 8.27 Cylinders and valves should be kept free from oil, grease and other debris. Cylinders should not be marked with chalk, crayon, paint or other materials, nor by the application of adhesive tapes etc. A tie-on label indicating the content state may be attached to the cylinder. 8.28 Smoking and naked lights should be prohibited in the vicinity of all cylinders. 8.29 Cylinders should always be secured during transportation and in use.
36
8.30 Safety devices, including pressure relief devices, valves and connectors should not be altered or by-passed. 8.31 Repairs, alterations or modifications should not be undertaken on any part of an MGPS, including pressure reducing regulators, except by appropriately trained personnel with adequate service facilities including maintenance manuals and recommended spares. 8.32 Markings used for identification of cylinder contents, pressure testing of cylinders, tare weights, etc, should not be defaced or removed. This also applies specifically to cylinder product labels. 8.33 Cylinders should not be painted or otherwise obscured in a manner which would prevent identification of their contents, and care should be taken to preserve their labels and surface finish. 8.34 Cylinders used for industrial purposes should not be used for medicinal applications and should not be stored in the same store as medical gases cylinders. Similarly, medical gases should not be used for non-medical applications. 8.35 Cylinder valves should not be dismantled or tampered with.
8.36 Cylinder valves should always be closed after use and when cylinders are empty. Keys for this purpose should be readily available. Any gas trapped within the regulator/equipment should be safely vented to atmosphere and the equipment valves re-closed. Protective clothing 8.37 Heavy protective gloves (preferably textile or leather) and protective safety footwear should be worn when loading or unloading cylinders, to minimise the risk of injury. Gloves, protective boots and overalls should be clean and free from oil and grease. Additional precautions are required for handling cryogenic gases, see paragraphs 9.17 to 19.19. Unloading equipment 8.38 The joist or tail-loader used with the delivery vehicle should be as clean as is practicable and mechanical parts shielded to prevent contamination of cylinders with oil and grease. Trolleys, trucks and vehicles 8.39 a. The following should be noted: cylinder trolleys should conform to BS 2718. Where different types of conveyance are used to transport several cylinders together, they should be clean, the cylinder supporting surfaces should be free from grease and oil and they should be reserved for the transportation of gas cylinders; precautions should be taken to prevent cylinders falling from trolleys, trucks or vehicles.
b.
8.40 Vehicles transporting gas cylinders and using public roads should, where applicable, be appropriately marked in accordance with the proposed
37
requirements of the Health and Safety Executives Packaging of dangerous substances for conveyance by road. Transportation of cylinders with equipment attached 8.41 In some circumstances it may be necessary to transport cylinders with equipment attached. Unless it is essential for a patient to continue receiving a supply of gas, the cylinder valve should be closed and any gas contained in the equipment or regulator should be safely vented to atmosphere before transporting the cylinder. Preparation of cylinders for use 8.42 a. b. c. d. The following preparations should be made before use: check the cylinder label to ensure the correct gas has been supplied; the tamper-evident seal should be removed and any plastic outlet cap removed and left attached to the valve for re-fitting after use; cylinders should only be used in conjunction with equipment designed for their use; cylinder identification labels should not be removed or obscured. No permanent marking or painting should be made to the cylinder shell, except by the manufacturer/supplier; lubricants, sealing or joining compounds should not be used when connecting cylinders to pressure reducing regulators. The cylinder valve, regulator and associated equipment should always be clean and free from oil, grease and other debris; cylinder and equipment connection interfaces and their washers or O ring seals should be inspected to make sure that they are in good condition. Damaged sealing washers and O rings should be replaced. Not more than one sealing washer should be used at each interface; portable nitrous oxide/oxygen cylinders should ideally be stored at above 10C prior to use; where the temperature falls below 0C it is possible for the constituent gases to separate. If cylinders are stored at temperatures lower than 0C for long periods prior to use, they should either be inverted at least three times or stored at above 10C for 24 hours prior to use to ensure the correct gas specification. Under no circumstances should cylinders be immersed in water prior to use; in the case of large (G-size) nitrous oxide/oxygen mixture cylinders, they should be stored upright within the manifold room at a minimum temperature of 10C for a period of 24 hours before connection to the manifold.
e.
f.
g.
h.
Connecting cylinders to equipment or manifolds 8.43 a. The following procedures should be implemented: connect the cylinder to the equipment or manifold tail pipe and tighten firmly with the recommended key or by hand as appropriate. Excessive force should not be used; ensure that no leaks are present at the junction between the cylinder valve and equipment and also between the valve spindle and gland nut. This may generally be determined by sound. If in doubt, use a
b.
38
proprietary leak detection fluid. If a proprietary fluid is used, it should be wiped off with a clean damp cloth after use. When tightening connections to stop gas leaks, excessive force should not be used. Sealing or jointing compounds should never be used; A 1% solution of Teepol should be used for leak testing on cylinder connections c. the connection between the cylinder valve and equipment should be checked for leaks using an approved leak detector. When tightening the connection to stop gas leaks, excessive force should not be used; prior to opening the cylinder valve, ensure the equipment flow control valves are closed; using a recommended cylinder spindle key, or handwheel where fitted, the cylinder valve should be opened slowly to its fullest extent by turning the valve spindle anti-clockwise. The spindle is then turned back by approximately a quarter turn. A faulty key or excessive force should not be used, as these may damage the valve spindle; regulators or equipment should only be used with the gas for which they are designed; prior to opening the cylinder valve, ensure that the equipment flow control valves are closed; when the cylinder is not being used, the cylinder valve should be closed and the gas trapped within the regulator/equipment should be safely vented to atmosphere by opening the flow control valve and then closing it again.
d. e.
f.
For two-stage regulators, the outlet pressure valve should be fully turned in an anti-clockwise direction
g. h.
Cylinder preparation for return to store 8.44 a. After use: the cylinder valve should be closed, any gas contained in the equipment and regulator should be safely vented to atmosphere and the equipment/regulator flow control valve closed. If the cylinder is to be removed or replaced, the recommended key should be used to disconnect the regulator or equipment; empty cylinders or those no longer required for use should be returned to store as soon as possible and appropriately identified as empty. Protective outlet caps, where supplied, should be replaced.
b.
39
Administration equipment 8.46 a. The following procedure should be implemented: lung ventilators, oxygen therapy apparatus and other equipment for use with cylinders should be so designed as to render the entire assembly stable during storage, transportation and use. If castors are used, they should conform to BS 2099; mobile equipment should be suitably buffered to reduce damage to the fabric of the healthcare buildings (see BS 4322); where a pressure relief valve is fitted to protect downstream systems, it should be indelibly marked with its relief pressure value. Regulators should be indelibly marked with the maximum outlet pressure range. Pressure gauges should be in accordance with BS 1780; needle valves or similar devices should not be used in place of pressure-reducing regulators, as excessive pressure may develop downstream of such devices and result in possible injury to personnel and damage to equipment.
b. c.
d.
40
8.50 Excessive force should not be used when connecting cylinders or closing valves, as this may damage threads and valve seats. The need for excessive force may indicate a faulty valve seat and it should be reported to the supplier. The cylinder should be removed from use and identified as faulty by tying a label to the cylinder. 8.51 Sealing or joining compound should not be used to rectify leaks. Any leakage which cannot be rectified should be notified to the manufacturer and/or electro-biomedical equipment (EBME) department as appropriate in accordance with the operational policy. 8.52 Cylinders with damaged or very stiff valves should be labelled appropriately and returned to the supplier. Equipment should be subject to planned preventative maintenance, see Chapter 10, Maintenance Defective equipment should be notified to the appropriate body in accordance with the defect reporting system. 8.53 Defective pressure-reducing regulators, gauges and equipment may be hazardous in use. A system should be set out in the operational policy to ensure that defective items are withdrawn from use, and repaired or replaced as necessary. 8.54 No attempt should be made to repair, alter or modify any cylinder or its valve other than that advised in paragraph 8.48 (b)(i).
41
42
Cylinders placed in or returned to the ready-to-use store should be checked for leakage, to ensure that the cylinder valve is turned off. An adequate number of keys should be available.
8.70 Small cylinders of oxygen/nitrous oxide mixtures should be kept horizontal and placed away from ventilation openings where practicable.
Returns to suppliers
8.73 The written procedure should detail the method of accounting for and returning of cylinders to the suppliers. Empty cylinders should not be retained longer than necessary in the main store, but returned at the earliest opportunity to the supplier to avoid unnecessary rental charges. This may also be covered by the automatic replenishment system described above.
43
c.
8.77 The following procedures for the rotation of stock should be implemented: a. b. a written procedure should be prepared giving details of a rotational stock-control system; the main store should be large enough to permit the use of a rotational stock-control system. Racks for small cylinders should be designed to assist rotation of stock; where a system incorporating an in-use bay and a latest-delivery bay is used, the in-use bay should be emptied before a fresh delivery is loaded into it. Appropriate movable signs should be available.
c.
Labelling/marking of cylinders
8.78 Cylinders should be colour-coded and marked in accordance with BS 1319 and the Classification of Packaging and Labelling of Dangerous Substances Regulations, SI 1244 1994 and 92/27 EC. 8.79 a. b. Each cylinder should have: a batch label to include a unique batch number, filling branch code, cylinder code and product, filling date and expiry date; product identification label which includes: (i) the product licence number; (ii) the name and chemical symbol of the gas or gas mixture contained in the cylinder. Additionally, in the case of gas mixtures, the proportion of constituent gases should be shown; (iii) a hazard warning sign; (iv) a substance identification number; (v) specific product and cylinder handling precautions; (vi) particular instructions to the user where necessary; (vii) safety information; c. d. a serial number; test mark, year and quarter of test.
8.80 Cylinders, pressure-reducing regulators and pressure gauges should be conspicuously marked use no oil or grease or with the appropriate symbol.
44
8.81 Cylinder yokes, pressure-reducing regulators and pressure gauges should be clearly and indelibly marked with the designation of the gas or gas mixture for which they are intended. BS 1319 may be used as guidance. 8.82 Pressure gauges should be in accordance with BS 1780 or with the appropriate standard for the particular type of medical equipment or to BS 4272: Part 3: 1989, as appropriate.
Notices
8.86 Smoking, welding and naked lights are prohibited within or near the manifold room, plantroom and liquid oxygen compound area and the cylinder store. This prohibition also applies to the vicinity of the outlet of the discharge pipe from medical gas safety valves. Safety signs should be provided within and outside these areas to indicate this requirement, for example smoking, welding and naked lights prohibited medical gas storage area. In addition, a notice clearly indicating the contents of these areas should be displayed. 8.87 Safety signs should be provided in accordance with the Safety Signs Regulations 1980 and are available from the gas supplier. Further guidance is also given in HTM 65 supplement for fire safety signs. 8.88 Notices should be posted in wards and departments informing staff of the location of those medical gas control valves which should be turned off in the event of a major fire in the ward or department.
45
Classification of hazardous areas for the selection of electrical equipment based on BS 5345: Part 1: 1976
8.91 By implication, an area that is not classified Zone 0, 1 or 2 is deemed to be a non-hazardous or safe area with respect to the code of practice. The code of practice is based on the concept of dealing with the risk of fire and explosion by area classification. 8.92 This concept recognises the differing degrees of probability with which concentrations of explosive (flammable) gas or vapour may arise in installations, in terms of both the frequency of the occurrence and the probability, that is, duration of existence on each occasion. 8.93 The definitions appropriate are as follows:
a. Zone 0 in which an explosive gas-air mixture is continuously present, or present for long periods; b. Zone 1 in which an explosive gas-air mixture is likely to occur in normal operation; c. Zone 2 in which an explosive gas-air mixture is not likely to occur in normal operation and if occurring will only exist for a short time.
Reference should be made to BS 5345 before specifying or installing electrical equipment for cylinder storage areas.
46
General safety
General 9.1 a. b. c. d. The safety of MGPS is dependent on four basic tenets: identity; adequacy; continuity; quality of supply.
9.2 Identity is assured by the use of non-detachable gas-specific connections throughout the pipeline system, including terminal units, connectors, etc, and by the adherence to strict testing and commissioning procedures of the system. Industrial shrader outlets do not comply with BS 5682 and should not be used. 9.3 Adequacy of supply depends on an accurate assessment of demands and the selection of plant with capacity appropriate to the clinical/medical demands on the system. 9.4 Continuity of supply is achieved by the specification of a system which, with the exception of liquid oxygen and separated synthetic air systems, have duplicate components and by the provision of an adequate emergency/reserve supply for all systems, except vacuum, by the provision of alarm systems and by connection to the emergency power supply system. Anaesthetic gas scavenging systems (AGSS) and high-pressure surgical air systems are not considered as life-support systems and therefore duplicate components and an emergency/reserve supply system is not necessarily required. Adequate provision should, however, be made for continuity in the event of a failure of the supply. 9.5 Quality of supply is achieved by the use of gases purchased to the appropriate European Pharmacopoeia (Ph Eur) requirements or produced by plant performing to specified standards, by the maintenance of cleanliness throughout the installation of the system and by the implementation of various testing and commissioning procedures. Modifications 9.6 Special precautions are required when existing installations are to be modified or extended, to ensure that any section of the pipeline system remaining in use is not contaminated or the supply to patients compromised. The section to be modified should be physically isolated from the section in use. Closure of isolating valves is insufficient for this purpose. Where area valve service units (AVSUs) have been installed, the blanking spades should be used. This isolation procedure is not required when work is to be carried out on individual terminal units, providing that no brazing is required.
47
9.7 Modification of existing systems may be detrimental to the overall performance of the system. In the case of older systems there may be insufficient capacity to permit the system to operate safely with the flows typically encountered in use today. 9.8 Any work involving alteration, modification, extension or maintenance work on an existing system should be subject to the permit-to-work procedure see the Permit-to-work section of Chapter 6 Operational procedures.
9.10 When oxygen therapy equipment is in use, fire and safety warning signs/labels should be conspicuously displayed at the site of administration to alert the patient, healthcare personnel and visitors that oxygen is being used and of the need to take appropriate precautions. It is recommended that the text is accompanied by a warning sign. 9.11 When oxygen is being administered in paediatric departments, the text should include the precaution: Only toys approved by the hospital fire officer may be given to the child. 9.12 Oxygen canopies, hyperbaric chambers and tents should be labelled, advising that oxygen is in use and that safety precautions relating to its use should be observed. Labels should be attached to the fabric of the canopy/tent in a position easily seen by the patient and also on the exterior in a position to be seen easily by healthcare staff and visitors. 9.13 Considerations may need to be given for signs in other languages. The guidance given in Firecode: Policy and principles should be followed.
9.14 All users of oxygen and associated equipment should know and understand the properties of oxygen and should be trained in the use of the equipment. This applies to all staff. 9.15 a. The health hazards associated with liquid oxygen are: cold burns and frostbite. Localised pain usually gives a warning of freezing, but sometimes no pain is felt or it is short-lived. Frozen tissues are painless and appear waxy, with a pale yellowish colour. When the frozen tissue thaws it can result in intense pain with associated shock. Loosen any clothing that may restrict blood circulation and seek immediate hospital attention for all but the most superficial injuries. Do not apply direct heat to the affected parts, but if possible place the affected part in lukewarm water. Sterile, dry dressings should be used to protect damaged tissues from infection or further injury, but they should not be allowed to restrict the blood circulation. Alcohol and cigarettes should not be given; the effect of cold on lungs. Prolonged breathing of extremely cold atmospheres may damage the lung tissue;
b.
48
c.
hypothermia. A risk of hypothermia arises when liquefied atmospheric gases are released. All persons at risk should be warmly clad. Hypothermia is possible in any environment below 10C, but susceptibility depends on length of exposure, atmospheric temperature and, not least, the individual. Older people are more likely to be affected; the formation of mist. When liquefied atmospheric gases are released, a white mist is formed by the condensation of atmospheric moisture when liquefied gas is in contact with it. The mist formation may cause injuries as a result of tripping because of poor visibility. In the event of mist formation, extreme caution should be exercised when evacuating the area.
d.
Material compatibility
9.16 Gaseous oxygen vigorously supports combustion of many materials which do not normally burn in air, and is highly dangerous when in contact with oils, greases, tarry substances and many plastics. Only materials approved for oxygen service may be used.
49
Fire precautions
General 9.21 The general guidance on fire precautions given in Firecode should be followed. Specific guidance on fire precautions relating to cylinders is given in Chapter 8 Cylinder management. 9.22 Guidance is also available from the gas supplier and any specific recommendations should be followed. 9.23 a. b. c. Fire can occur when the following three conditions are present: flammable materials; oxidising atmosphere; ignition.
9.24 Flammable materials should not be present in cylinder stores, manifold rooms or liquid oxygen compounds. It may not, however, be possible to avoid the presence of flammable materials in the vicinity of the patient when medical gases are being used. 9.25 Flammable materials which may be found near patients include some nail varnish removers, oil-based lubricants, skin lotions, cosmetic tissues, clothing, bed linen, rubber and plastic articles, alcohols, acetone, certain disinfectants and skin-preparation solutions. 9.26 An oxygen-enriched atmosphere may be present when medical oxygen or nitrous oxide/oxygen mixtures are used. Nitrous oxide also supports combustion. 9.27 Staff should be aware of the contents of HTM 83 and HC(78)4, The Organisation and Maintenance of Fire Precautions in the National Health Service. 9.28 Further guidance should be obtained from the fire prevention officer, the fire safety officer and the local fire brigade. 9.29 a. Ignition sources are numerous and include: open flames, burning tobacco, sparks (which may also be produced by some childrens toys); high frequency, short wave and laser equipment; hair dryers; arcing; and excessive temperatures in electrical equipment. The discharge of a cardiac defibrillator may also serve as a source of ignition; electrical equipment not specifically designed for use in an oxygenenriched atmosphere; some non-electrical equipment. For example, a static discharge, which may be created by friction, may constitute an ignition source if easily ignited substances such as alcohols, acetone, some nail varnish removers, oils, greases or lotions etc are present. In Scotland, NHS Circular No 1978(GEN)42 applies.
b. c.
9.30 A mixture of breathing gases will support combustion. In an oxygen or nitrous oxide-enriched atmosphere, materials not normally considered to be flammable may burn vigorously. Flammable materials ignite and burn more vigorously.
50
9.31 Clothing may become saturated with oxygen or nitrous oxide and become an increased fire risk. When returned to normal ambient air, clothing takes about five minutes for oxygen enrichment to reduce to normal conditions. Blankets and similar articles should be turned over several times in normal ambient air following suspected oxygen enrichment. 9.32 Oil and grease, even in minute quantities, are liable to ignite in the presence of high-pressure oxygen or nitrous oxide. No oil or grease should be used in any part of the MGPS. In particular, oil-based lubricants should not be used and all fittings, pipes etc should be supplied degreased, sealed and labelled for MGPS. Details of these requirements are given in Design considerations. 9.33 The siting and general structural principles for the design of liquid oxygen storage accommodation are stated in Chapter 6 of Design considerations and for plantrooms and gas manifold rooms in Chapter 14 of Design considerations. Cylinder storage should be as recommended in Chapter 8 Cylinder management.
Ventilation
9.34 Waste anaesthetic gas discharges are usually controlled by scavenging and/or ventilation to comply with the requirements of COSHH. Where oxygen is used for specific therapies, for example in oxygen tents or in continuous positive airway pressure (CPAP) ventilation regimes, oxygen enrichment may occur. It is essential, therefore, that adequate general ventilation should be provided to avoid the hazard.
51
10.0 Maintenance
General
10.1 MGPS should be subjected to planned preventative maintenance (PPM) and should be under the responsibility of the authorised person (MGPS), irrespective of whether or not a full preventive maintenance scheme is being implemented in the hospital as a whole. 10.2 All work should be carried out in accordance with HTM 2022 and/or C11 as applicable and as modified from time to time. 10.3 All work on an MGPS, whether or not the supply is or is likely to be interrupted, should only be carried out under the instructions of, and with the prior permission of, the authorised person (MGPS). 10.4 Since the authorised person (MGPS) is responsible for the operation of the MGPS, his/her decision should be final in all cases. 10.5 The operational policy should clearly set out the responsibilities and the procedures to be followed for all work on the MGPS. 10.6 No work should be carried out on an MGPS unless a permit has been issued. This includes all examinations where no interruption to the service is anticipated.
Organisation
10.7 Inspection and maintenance should be carried out using one of the following methods: a. on a contract basis by an approved specialist company registered to BS EN ISO 9000 (or BS 5750), with scope of registration defined to include maintenance of MGPS. Please see previous marginal note on the review of the concept of the existing QAS scheme; by properly trained hospital staff (essential for daily, weekly and other tasks); by a combination of (a) and (b) with a clear division of responsibility. For example, electric motors and water treatment apparatus maintained by hospital authority, the remainder maintained by contract.
b. c.
10.8 The authorised person (MGPS) should be responsible for monitoring the maintenance work carried out by the contractor. 10.9 All work carried out should be subject to the permit-to-work system, and accepted by the authorised person (MGPS) prior to the contractor leaving site.
52
10.0 Maintenance
10.0 Maintenance
The trust may also issue its own identity or other pass which the contractor should display if so requested. 10.23 The trust will provide details of its fire policy and the contractor will be required to comply with this policy. The contractor should instruct his staff in the requirements of the fire policy. 10.24 The contractor should remove from the premises any of his staff if requested to do so by the authorised person (MGPS) or where the trust so requests on the grounds of efficiency, competence or public interest. 10.25 No work should be carried out, including examination of terminal units, unless a permit-to-work has been issued by the authorised person (MGPS) in accordance with the permit-to-work procedure.
54
10.0 Maintenance
Table 2 Training log and skills matrix Form 1: Training log Name: Position: Qualification: Experience: Summary of training to date: Training certificates: Training course title: Date: Type of training: initial course: refresher: re-assessment: Description of training: authorised person (MGPS): competent person (MGPS): specific equipment: Instructor/training course provider: Assessor:
Competence level Current level of competence Trainee 0 Level 1 Level 2 Level 3 Level after training Trainee 0 Level 1 Level 2 Level 3
Instructors comments/assessments
55
10.0 Maintenance
Engineer:
Current status: project manager senior service engineer service engineer competent person (MGPS) trainee
Classification: Trainee 0: Only to carry out work under the direct supervision of a competent engineer Level 1: Qualified to carry out routine service, unsupervised, working to set procedures Qualified to carry out unsupervised services to set procedures and act on own initiative Qualified to carry out unsupervised maintenance and major repairs and modifications working to set procedures and on own initiative.
Level 2:
Level 3:
The contractor should identify the skill level associated with each task in the method statement, and allocate staff with appropriate skill levels to carry out the work.
10.37 Ideally, the contractor should only employ his own staff to carry out the maintenance services. 10.38 Where the use of sub-contract staff is unavoidable, the contractor should obtain prior permission from the trust to use such staff. 10.39 The contractor should ensure that any sub-contract staff are at least as competent as his own staff and have received appropriate training and experience. 10.40 The contractor should not allow any staff to work unsupervised on a site unless they have received the appropriate training as detailed in this section and in accordance with HTM 2022. 10.41 Where the contractors staff are not familiar with the MGPS at the site, the authorised person (MGPS) should initially familiarise the contractors staff with the site, prior to carrying out any PPM work.
Test equipment
10.42 The contractor should provide all appropriate test equipment. The test equipment should be in accordance with HTM 2022 Design considerations. 10.43 The test equipment should be calibrated in accordance with the manufacturers recommendations, but in any case against NAMAS standards.
56
10.0 Maintenance
10.44 Calibration certificates should be available if requested. 10.45 When carrying out tests on terminal units, it is not sufficient to use only blank test probes. Such blank test probes should only be used for leak tests; a calibrated flowmeter and pressure gauge, together with appropriate calibrated jet, should be used to carry out flow and pressure drop tests. 10.46 The contractor should identify the test equipment appropriate to each task in the method statement see paragraphs 10.5910.62.
Services
10.47 The contractor should carry out the services specified in the contract on the dates or at the intervals specified in the contract. 10.48 A schedule of minimum tasks to be carried out, together with the minimum recommended frequency, is given in paragraphs 10.11710.126. This may be modified by individual trusts as appropriate for their particular requirements. 10.49 Except where specifically provided for in the contract, and excluding emergency call-outs, all visits should be scheduled to take place on week days, between 08:30 and 17:00 hours. 10.50 It should be the responsibility of the trust to ensure that access to the plant and systems are available to the contractor. It may not be practical for access to operating departments and other high dependency areas to be available during normal working hours; in this case the Contractor should liaise with the authorised person (MGPS) to ensure that the work is carried out with due regard for the clinical requirements. Where access to such departments is routinely unavailable during normal working hours, this should be specified in the contract. 10.51 The contractor should liaise with the authorised person (MGPS) to arrange for such access at least one week before the due date of the visit. 10.52 In addition to the tasks set out in this chapter, the contractor should replace wearing parts on a routine basis, but excluding the regular inspections of the vacuum insulated evaporator (VIE) and equipment operated from the pipeline system in accordance with paragraph 10.94 of this volume. 10.53 In addition to the regular maintenance programme set out in the schedule in Appendix I, the contractor should provide service engineers to carry out additional tasks as requested by the authorised person (MGPS). These tasks may be routine, non-urgent maintenance tasks, or may be emergency call-out tasks. 10.54 For non-urgent tasks, the extent, cost and time, and approximate duration of the work should be agreed between the contractor and the authorised person (MGPS) and confirmed in writing. 10.55 For emergency call-outs see paragraphs 10.71 to 10.78. 10.56 Prior to leaving site, on completion of the tasks, the contractor should report to the authorised person (MGPS) to sign off the permit-to-work and to provide any other information regarding additional work required, remedial work, faults found etc. 10.57 The authorised person (MGPS) should sign to the effect that the work has been carried out satisfactorily prior to the contractor leaving site. 10.58 It is the authorised person (MGPS)s responsibility to satisfy himself/ herself that the work has been carried out in accordance with the contract.
57
10.0 Maintenance
Method statement
10.59 A list of recommended tasks to be carried out at specified frequencies is given in Appendix I. 10.60 The tasks are listed as generic tasks. The contractor should prepare a method statement for each of the tasks identified. 10.61 The method statement will be applicable to the actual plant and equipment which is installed on a particular site. 10.62 The method statement should include the following information: sequence of tasks to be performed; procedures to be followed, for example permit-to-work, obtaining permission from ward staff, safety procedures etc; the grade, competency and number of staff to carry out the tasks; the test equipment to be used; the approximate time to complete the tasks; the documentation/report to be completed.
Records
10.63 The following records are to be completed following each and every visit to the premises, and after any work is carried out: 10.64 A signed and dated report form which includes the following details: company; time and date of arrival on site; trust order number; location, number and type of plant/equipment; details of work carried out, ie planned maintenance, breakdown, emergency call-out, etc details of break down as reported, cause of breakdown, action taken; details of spares used; details of any further work required, urgency and implications; details of defects noted and remedial work required; time of leaving site; name of contractors staff and grades; signatures: contractors engineers on site, authorised person (MPGS) for the trust on arrival and prior to departure, clinician/nursing officer for department visited. 10.65 For each area visited, the work record should be signed by the departmental manager, nursing officer or clinician as appropriate, with the time and date of the visit. This is to provide a written record that the particular department has been visited; it in no way implies any responsibility by the clinical or nursing staff with regard to the scope and effectiveness of the work
58
10.0 Maintenance
carried out. Variations in signature protocols should be agreed with the authorised person (MGPS). 10.66 A maintenance log is to be maintained for each plant item and is to be updated following each planned maintenance visit or any work carried out. The format of the maintenance log is to be specified by the authorised person (MGPS) and the log should be kept by the authorised person (MGPS). A copy will be made available to the contractor for his records if so requested. 10.67 Following the completion of the service, the contractor should affix a label to each plant item providing the following information: contractors name, address and telephone number; the date the work was carried out; name and signature of service engineer; date of next planned service. 10.68 In addition, a barcode may also be affixed which is coded with the details of the service record. 10.69 It would not be practical to affix such a label to each terminal unit following planned maintenance. Therefore, a label giving the above information and the location of the terminal units should be affixed adjacent to the area valve service unit (AVSU) serving the area. 10.70 A schedule of the actual tests results for each terminal unit should be maintained and retained in the maintenance log.
59
10.0 Maintenance
maximum time from receipt of the initial call as specified in the maintenance contract by the trust. The geographic location of the trust, number of trusts authorised and competent persons (MGPS), and availability of technical guidance are all considerations when defining the emergency response time. For normal circumstances a response time of two hours is recommended. 10.77 The contractor should be responsible for maintaining a reasonable stock of spares to facilitate emergency call-outs. The contractor should be familiar with each site and should therefore be able to reasonable anticipate the most likely spares which will commonly be required. 10.78 The contractor should submit with his tender a general statement on his capability to support the requirements of the trust. This should include details on the various resources available to him, number of staff employed, levels of competence, emergency support provision, and should define the level of technical advise and support that the contractor can provide. The contractor should also identify other similar contracts being undertaken.
60
10.0 Maintenance
irrespective of whether or not the systems comply with the recommendations in HTM 2022. 10.87 All work should be carried out in accordance with HTM 2022 and C11as appropriate. 10.88 Appendix I gives specific recommended checks on the MGPS, including particular details of daily and weekly test recommendations. These tasks are usually carried out by the trust, however the trust may wish the contractor to carry out these tasks as an additional contract. 10.89 Appendix I provides a recommended schedule of services for the MGPS based on quarterly and, where appropriate, annual tasks. 10.90 In conjunction with the manufacturers recommendations, the guidance given in these sections should enable a PPM schedule to be prepared; or enable management to scrutinise a contractors proposals with ensure compliance with these recommendations. Preparation 10.91 The suppliers should be required to provide complete as-fitted drawings, circuit diagrams, valve charts and maintenance instructions, which should be used as the foundation for the PPM programme. For new plant the PPM programme supplied by the manufacturers should be used. The terms used in the PPM programme and their definition are as follows: Examine To make a careful and critical scrutiny of an item without dismantling, by using the senses of sight, hearing, smell and touch, to verify that the plant or equipment is in working order. Test To operate the plant or equipment and/or use the appropriate testing instruments to ensure that plant or equipment is functioning correctly.
Check To make a thorough inspection for damage, wear or deterioration. Also to ascertain that the plant or equipment is correctly adjusted to conform to the required standard. 10.92 The actual frequency of maintenance routines should be established from the manuals for the equipment and plant. Practical experience with equipment of different manufacturers, and information from plant history logs, might well result in the need to vary some frequencies and tasks in particular installations.
61
10.0 Maintenance
Exclusions 10.94 The PPM programme does not cover the regular inspections considered essential for the safe operation of bulk liquid oxygen installations. Records and plant history logs 10.95 The results of each inspection, and any action taken to correct faults found during the inspection, should be recorded. Arrangements should be made so that action can be instituted to correct apparatus giving constant trouble caused by faulty design or by unsatisfactory conditions of any nature. Provision should be made for maintenance tasks and their frequency to be modified when necessary. 10.96 Counters which record the hours of operation of each compressor and vacuum pump have been suggested in Chapter 7 of Design considerations. The readings of these counters can be used in conjunction with the recommendations of the manufacturers for the modification of the programme. Equipment checklists 10.97 The installations include a great number of AVSUs, pressure-regulating valves, filters, indicating lights and audible alarms. Equipment checklists should be prepared for each of these groups of items. AVSUs and pressure-regulating valves should be referred to by number in the checklist, and this number should correspond with that on the valve itself. It is usually convenient to arrange these checklists in such a manner that a record can be made against each valve showing whether it has been examined, tested or checked in accordance with the PPM programme. Maintenance of filters 10.98 It is not possible to specify in advance the frequency with which the various filters on the MGPS should be cleaned or changed. Inspection should be in accordance with the manufacturers recommendations and take account of local conditions. Maintenance of blenders 10.99 Maintenance should be carried out in accordance with the manufacturers instructions. Maintenance of compressed air dryers and pressure swing adsorber (PSA) columns 10.100 It is not possible to specify the frequency with which air dryer desiccant charges or PSA columns should be replaced. The desiccant should be checked at intervals and by methods recommended by the supplier. The charge should be replaced with the appropriate material in accordance with the recommendations of the supplier. A record of the type, batch number of desiccant and date of change should be kept. 10.101 The quality of gas from PSA and medical air compressors should be tested quarterly, in accordance with the procedures in Design considerations. Plug-in type terminal filter assemblies used in association with breathing systems do not form part of the MGPS. AGSS are prone to collecting lint which blocks filters and affects performance.
62
10.0 Maintenance
Maintenance of medical gas manifolds 10.102 The engineer should examine the effectiveness of the various pressure regulators each day by observation of the supply pressure gauges and, simultaneously, ensure that any indicating lights show the actual condition at the time of this routine inspection. If any manifold is observed to be in operation on its reserve bank, he/she should ensure that replacements for the empty cylinders will be available in good time. Maintenance of equipment for use with gas cylinders Relevant SHHD circular 1977(GEN)68 and 1979(GEN)40. Not adopted in Scotland. 10.103 Equipment for use with medical gas cylinders, including piped medical gas distribution systems, should be subject to routine inspection and maintenance in accordance with the manufacturers recommendations and, where appropriate, it should be subject to PPM (advice is given in HEI 98). Maintenance work must be carried out only by competent and qualified staff. Maintenance of bulk liquid oxygen (VIE) systems 10.104 VIE maintenance is the responsibility of the gas supplier, but there are customer checks which should be carried out daily and weekly. In addition, it may be necessary to test the warning and alarm system. The high line pressure alarm requires specialist test equipment contact the gas supplier. 10.105 In this case each alarm condition is initiated by the operation of a pressure switch. The control panel is supplied with three-way ball valves on the oxygen supply lines to each pressure switch. Rotation of these valve handles through 180 allows oxygen pressure to the pressure switches to be reduced. This action operates the pressure switches and the hospital alarms. 10.106 follows: a. b. c. d. e. f. g. Weekly customer checks should be carried out by the hospital as
check mechanical joints for obvious signs of leaks; check for mechanical damage; check that the pressure setting of the VIE inlet is set at 10.5 bar g; check that the pressure setting of the distribution pipeline is set at 4.2 bar g; where cylinder back-up is used, check that the pressure of the cylinders on the reserve manifold is above 68 bar g; where liquid back-up is used, check (a) and (b) above and that the back-up vessel is set at 8.5 bar g; ensure that there is no build up of rubbish/flammable material within the vessel compound.
10.107 The VIE reserve manifold needs to be checked weekly. This is particularly important, since the emergency manifold is very rarely used and a small leak can lead to the loss of a cylinder bank. In particular, the pressure of the reserve manifold cylinders should be checked weekly, as described in the above list. 10.108 In the event of an emergency, the authorised person (MGPS) should be aware of how to shut down the VIE system and the consequences of such action.
63
10.0 Maintenance
Medical vacuum systems: bacteria filters standard operational procedure for filter changing
General 10.109 Before carrying out any work on bacteria filters, the user is to advise on any toxic or infectious materials which may have been used and on appropriate precautions to be observed. 10.110 All staff, including contractors, should observe safety procedures as set out in the trusts safety policy. Permit-to-work 10.111 A valid permit-to-work form for safety purposes (this is not the same as the medical gases permit-to-work form) must be authorised by the trusts staff (usually the authorised person (MGPS)) before a filter is changed. 10.112 Where appropriate, a contractors permit-to-work must be issued and appropriately annotated.
10.115 All disposable protective clothing, that is, mask, overalls, gloves and overshoes, are to be placed in the outer bag for disposal. Filter disposal 10.116 The following procedures should be observed: a. b. c. the used filter is to be placed directly into a heavy-duty polythene bag; this bag is to be placed inside a second bag, which is also sealed and labelled hazardous waste to be incinerated; the staff carrying out the filter change are to notify the waste disposal department and/or the authorised person (MGPS), as appropriate, so that the bags can be collected and disposed of.
64
10.0 Maintenance
10.118 The tasks listed under each item are to be carried out during every quarterly visit. 10.119 In addition to the quarterly tasks, additional tasks should be carried out annually, and these are listed separately. 10.120 For terminal units, the tasks listed should be carried out at a frequency specified by the trust, taking into account the amount of daily use the terminal unit undergoes, and also the age and design of the terminal units. As a minimum the work should ideally be scheduled such that one quarter of the terminal units are serviced during each service visit. 10.121 For each of the tasks listed here, where adjustments or other remedial actions are required this should be carried out at the time; where such action is not possible, for example where additional parts are required, this should be noted and reported to the authorised person (MGPS). 10.122 There are also statutory requirements with regard to pressure vessels and inspections; these tasks are not included here. 10.123 It is not recommended that safety valves are lifted; every safety valve should have a test certificate in accordance with HTM 2022. The safety valve should be replaced every five years under a planned replacement procedure. 10.124 Statutory obligations under the Pressure Systems and Transportable Gas Containers Regulations require the periodic testing of pressure safety devices. It is not appropriate to test a medical gas pipeline system by either raising the line pressure regulator setting or manually unseating the relief valve. Such action could result in failure of anaesthetic equipment, and in the event of failure of the safety valve to re-seat, considerable gas loss and further hazard. Medical gas pipeline line distribution systems should be provided with a pressure relief device downstream of the line pressure regulator connected by means of a three-way cock so that the safety device can be exchanged for a certificated replacement in accordance with the frequency required by the Regulations. 10.125 a. b. c. d. e. f. g. h. j. The following services are covered in this schedule:
general safety requirements; medical compressed air and surgical air plant; medical gas manifolds; emergency reserve manifold; medical vacuum plant; pipeline distribution system; warning and alarm systems; anaesthetic gas scavenging systems (AGSS); yearly tasks in addition to quarterly tasks.
65
Risk assessment
11.5 The risk assessment will be based on the exposure limits that came into effect on 1 January 1996, published by the Health and Safety Executive, for nitrous oxide and the halogenated anaesthetic agents. 11.6 Detailed guidance on compliance with COSHH is given in EL(96)33, covering publication; Advice on the Implementation of the Health & Safety Commissions Occupational Exposure Standards for Anaesthetic Agents, published by the Department of Health 1996. Further guidance is given in Anaesthetic agents: Controlling exposure under COSHH, prepared by the Health Services Advisory Committee, ISBN 0-7176-1043-8. 11.7 Employers in this case executive managers have a statutory obligation to ensure that these levels are complied with in accordance with the COSHH regulations. 11.8 The published exposure limits have been shown to be achievable in areas where the maximum exposure to anaesthetic gases is likely to occur, that is, operating theatres and anaesthetic rooms. 11.9 Assessment of the risk will involve the following:
66
a.
identifying areas where exposure to anaesthetic gases can take place, and listing them in rank order, taking into account the likely exposure and duration the worst areas are, therefore, the operating room and the anaesthetic room; examination of the methods of control currently installed for example if a scavenging system is installed, its effectiveness will need to be established. It will probably be necessary to carry out monitoring of both the environment and exposed personnel in order to establish a base level. Where there is any doubt as to the effectiveness of an installed scavenging system, sampling of the environment together with personal samples of the anaesthetist and other staff who may be exposed to high concentrations, should be carried out. Where no scavenging system is installed in high risk areas, sampling of the environment should be carried out in order to assess the need.
b.
Methods of control
11.10 Effective control of exposure to anaesthetic gases will involve a combination of the following measures: a. b. c. the use of an effective scavenging system to remove the pollution at source; good room ventilation to dilute pollution from leaks, patients expired air etc; good housekeeping to minimise leakage, such as from poorly-fitted face masks, flowmeters inadvertently left on, poorly-maintained anaesthetic or scavenging equipment.
11.11 A scavenging system which complies with BS 6834:1987 should be installed in all new operating rooms and anaesthetic rooms. Where a scavenging system is already installed which does not comply with BS 6834:1987, its effectiveness should be assessed initially by monitoring the environment and by personal sampling. If the exposure exceeds a TWA of 100 ppm for nitrous oxide, consideration should be given to installing a system which complies with BS 6834. It should be emphasised, however, that the actual exposure is likely to be the result of pollution from several sources, such as leakage, and therefore the ventilation system and the maintenance of equipment should also be included in the assessment. Scavenging systems which conform to BS 6834:1987 are only appropriate for installation in operating rooms and anaesthetic rooms and should not be installed in other areas. 11.12 Anaesthetic gases are also administered in other areas such as maternity departments and dental clinics. In these areas there is currently no effective scavenging system available, and therefore a combination of good ventilation and good housekeeping will be required to minimise the exposure to anaesthetic gases. This also applies to recovery areas, where the concentrations expired by the patients are relatively low and no satisfactory scavenging system is available. Guidance on ventilation systems is given in HTM 2025. An air change rate of 15 air changes/hr is recommended for recovery areas.
Monitoring
11.13 Good housekeeping will be required in order to minimise leaks from equipment, poorly-fitting face masks, flowmeters left on unnecessarily, etc. The co-operation of all staff will be required to maintain a consistent
67
minimum exposure; this will require periodic monitoring and training for all staff. 11.14 The scavenging system should be tested in accordance with Chapter 15 of Design considerations. 11.15 The co-operation of all staff clinicians, nurses, theatre technicians, estates staff will be required in order to achieve compliance with these requirements. 11.16 It is therefore recommended that one person should be nominated by the general manager/chief executive to have responsibility for implementing these recommendations and co-ordinating a monitoring and training policy. 11.17 A monitoring programme should include the following: a. b. c. d. initial assessment of staff exposure; routine measurement of staff exposure; testing of scavenging systems; testing of ventilation systems.
11.18 An initial assessment of the actual staff exposure levels should be carried out either by monitoring the environment or by personal sampling of staff. This sampling should include staff in all areas where anaesthetic gases and agents are used, including areas where it is not possible to install a scavenging system, for example delivery rooms. 11.19 If the initial assessment shows higher exposure levels than would be expected, real-time monitoring of the environment may be required in order to establish the source of the pollution. Methods of personal sampling are 11.20 Personal sampling may be required routinely. currently being investigated.
68
12.0 Definitions
Definitions
Anaesthetic gas scavenging system (AGSS): A complete system which conveys expired and/or excess anaesthetic gases from the breathing system to the exterior of the building(s) or to a place where they can be discharged safely, for example to a non-recirculating exhaust ventilation system. Area valve service unit (AVSU): A valve assembly within an enclosure provided for maintenance or for connecting a temporary supply or, in emergency, for shutting off the gas flow to a specific area or for the purging and testing of gas supplies after engineering work. Authorised person (MGPS): A person who has sufficient technical knowledge, training and experience in order to understand fully the dangers involved and who is appointed in writing by the executive manager on the recommendation of a chartered engineer with specialist knowledge of MGPS. The certificate of appointment should state the class of work which the person is authorised to initiate and the extent of his/her authority to issue and cancel permits-to-work. The authorised person (MGPS) should have read, have understood and be able to apply the guidance in HTM 2022, especially in relation to validation and verification, and should also be completely familiar with the medical gases pipe routes, their means of isolation and the central plant. He/she should ensure that the work described in any permit-to-work is carried out to the necessary standards. Batch number: A distinctive combination of numbers and/or letters which specifically identifies a batch or lot and permits its history to be traced. Clients representative: The person, or that persons representative, as defined under the designated Standard Form of Building Contract issued by the Joint Contracts Tribunal 1980 (JCT 80). Competent person (MGPS): A person having sufficient technical knowledge, training and experience to carry out his/her duties in a competent manner and understand fully the dangers involved, and whose name is on the register of competent persons. The register should be maintained by either a specialist contractor or by the authorised person (MGPS) as appropriate. See also the definition of a contractor and paragraphs 5.335.35. He/she should be familiar with and able to read the record drawings and should have received specific training on MGPS. He/she should be able to identify all types of medical gases terminal units and should be familiar with all testing and commissioning procedures referred to in HTM 2022. The person maintaining the register should assess a persons competence, taking account of his/her training and experience. Competent person (Pressure Systems) as defined by the Pressure Systems and Transportable Gas Containers Regulations 1989. In the regulations three
69
12.0 Definitions
categories of system are defined and for each category different attributes are required for competent persons: a. minor systems: pressure less than 20 bar (2.0 MPa.) and the pressure volume product for the largest vessel should be less than 2 x 105 barlitres (20 MPa. m3); intermediate systems: these include systems that do not fall into either of the other two categories; major systems: steam-generating systems exceeding 10 MW, pressure storage systems in excess of 106 bar-litres (100MPa. m3);
b. c.
Most MGPS will fall into the minor systems category. A full list of the attributes required is given in the Regulations, but in summary, minor systems require at least incorporated engineer status while intermediate and major systems require chartered engineer status. Contract: The agreement concluded between the trust and the contractor, including all specifications, contractors samples, plans, drawings and other documentation which are incorporated or referred to therein. Contract supervising officer: The person authorised by the hospital authority to witness tests and checks under the terms of contract. He/she should have specialist knowledge, training and experience of MGPS and HTM 2022. Contractor: The contractor commissioned typically as a sub-contractor for the installation of the MGPS under the Standard Form of Building Contract issued by the Joint Contracts Tribunal 1980 (JCT 80). All contractors working on MGPS should be registered to BS EN ISO 9000 with scope of registration defined as appropriate. Decanting: The act of transferring oxygen under pressure, normally from a large cylinder to a smaller, usually transportable one. This procedure should only be carried out under controlled and documented conditions with the sanction of the quality controller (QC). Designated medical and nursing officer: The medical or nursing officer designated by the chief executive to act as a focal point for communications related to MGPS in a specified department or departments. There would ideally be a designated medical officer and a designated nursing officer in each department. The designated officer should give permission for any interruption to the MGPS. Designated person: A suitably trained person who has been given responsibility for a particular operation involving medical gas cylinders, for example responsibility for changing cylinders on the MGPS manifold. Equipment: A device, such as a pressure regulator and flow meter, which is connected to a single cylinder for the administration of medical gas to an individual patient or gas apparatus. Flammable: Capable of burning with a flame. HTM 22: Hospital Technical Memorandum 22 Piped medical gases, medical compressed air and medical vacuum installations (first published by HMSO for the Department of Health and Social Security as Hospital Technical
70
12.0 Definitions
Memorandum 22 in May 1972, and as amended by HN(76)175), and last reprinted in 1978 with minor corrections. Main cylinder storage area: The main area where all cylinders on a site are stored, excluding only those cylinders in use in manifold rooms or in ready-touse stores. Manifold room: A purpose-built room designed to accommodate a cylinder manifold installation and reserve cylinders as appropriate. Medical gas pipeline systems (MGPS): The fixed medical gases pipeline and the associated supply plant or pumping equipment and warning and alarm systems. This definition includes medical compressed air and medical vacuum installations and anaesthetic gas scavenging systems. Permit-to-work: A form of declaration or certificate in six parts, for signature as appropriate. It states the degree of hazard involved, defines all services to be worked on and the points where isolation of the affected sections are carried out. It also gives an indication of the work to be carried out. It is not a permit for the use of the installation for clinical purposes until all parts have been completed. A pro-forma is given in the permit-to-work section of Chapter 6 Operational procedures. Pipeline carcass: The pipeline installation with terminal unit base blocks and area valve service units (excluding pressure switches, flexible assemblies, etc). Pipeline manifold: A pipe to which cylinder tail-pipes are connected, which in turn is connected to the control equipment by means of which medical gas is delivered to the MGPS. Premises: The premises should be the hospital site, healthcare building or other establishment where the MGPS is installed and the services are to be provided, as defined in the contract. Pressure safety valve: A valve to limit pressure within the pipeline system. Pressure swing adsorber (PSA): Medical oxygen concentrator. System comprising compressor(s), nitrogen adsorber unit(s) and reservoir by means of which oxygen-enriched, clean, dry, oil-free air is generated from atmospheric air. Procedure: A written method which has been drawn up by a person familiar with the system and the requirements of this HTM, and checked by the QC or authorised person (MGPS), as appropriate. It should be signed by both persons and be dated, and include a review date. Protective cover: A tamper-evident means of protection of the cylinder valve or valve gas-outlet which may be achieved by a viscose seal, plastic cap or metal cover. Quality controller (QC): A person appointed in writing by the executive manager on the recommendation of the chief pharmacist. The QC should normally be a pharmacist or other suitably qualified person and should have specialist knowledge, training and experience of MGPS and HTM 2022. The QC is responsible for the quality of the medical gases; his/her duties include carrying out the quality tests in accordance with the procedures specified in Validation and verification.
71
12.0 Definitions
Ready-to-use store: A local subsidiary to the main store for a limited number of medical gas cylinders, usually cylinders for immediate use and one days supply for reserve purposes. Services: The services means the services and the goods which the contractor is required to supply in accordance with the contract. Specialist fire safety advisers: This post is fully described in Firecode: Policy and principles. Tail-pipe: A flexible connecting pipe which connects a medical gas cylinder to a medical gas pipeline manifold via a gas-specific connector. Training (gas cylinders): Formal instruction in the safe handling and storage of gas cylinders and associated equipment to ensure that all staff are aware of the dangers involved and will act accordingly. Trust: Trust means the NHS trust, Special Health Authority or other Health Authority as appropriate. Vacuum insulated evaporator: Cryogenic liquid system, source of supply containing liquefied gas stored under cryogenic conditions.
72
The following should be checked and any deficiencies or remedial action required should be notified to the authorised person (MGPS): a. b. c. d. e. f. g. safety notices appropriate notices clearly displayed in all plantrooms and cylinder stores; no smoking notices clearly displayed; discharge points/vents/vacuum/AGS warning notices clearly displayed; motor guards in position and in good repair; notices warning of automatic start-up in position and legible; plantrooms free from combustible material and with adequate access for maintenance; all cylinders properly stored/secured and all batch labels correct and in date.
73
Test:
Receiver(s) Examine: general condition safety valves for leakage security of holding-down bolts condition of isolating valves condition of flexible connections Check: pressure gauges pressure switches adjust as necessary operation of non-return valve operation of drainage trap safety valve discharge vent operation of pressure gauges replace as necessary
Test:
Separators and filters Examine: condition of separator condition of drainage trap Check: isolating valves filters
74
Dryers Examine: general condition heating elements or air-dried columns as appropriate Check: operation of heating elements/thermostats as applicable automatic release of air prior to drying process automatic re-pressurisation following drying process correct sequencing between columns on automatic/manual desiccant operation of pressure sensing devices operation of all automatic valves operation of dew-point sensor
Test:
Compressor control panel Examine: condition of control cabinet condition of electrical conduits earthing/continuity arrangements Check: security of electrical connections operation of pressure sensors terminal connections condition of cables operation of high- and low-pressure switches operation of starter and overloads operation of lamps and warning devices operation of duty selector switch operation of auto/manual selector operation of main isolation switches
Test:
Pressure regulators Examine: condition of all pressure regulators Check: safety valves regulator mountings locking devices where fitted operation of gauges operation of regulators adjust as necessary correct settings adjust as necessary
Test:
Warning and alarms system Test: operation of all alarms adjust as necessary
Compressor system Test: operation of plant by simulation of running and fault conditions system pressure quality of medical air to HTM 2022 quality specification
Record details of all plant data, including hours run, start-up/run current, cutin and cut-out pressure switch settings etc.
75
Tail-pipes Examine: general condition threads on tail-pipe header connection Check: for leakage replace tail-pipes and non-return valve seals as necessary
Control panel Note: the detailed tasks will depend on the type of panel installed. The manufacturers recommendations should be followed in all cases. The tasks listed here are generic, and the actual tasks should be detailed in the method statement.
Examine: general condition leakage earthing/continuity arrangements Check: electrical connections fuses operation of isolating valves safety valve for leakage safety valve discharge vent for blockage pressure regulator settings adjust as necessary lamps and warning devices pressure gauges operation of automatic changeover device operation of manual changeover device operation of pressure regulating devices pressure regulators for creep
Test:
76
Check:
security of fixings operation of isolating valves operation of pressure regulator safety valve for leakage safety valve discharge vent cylinder valves open or closed depending on automatic/manual system at least one cylinder valve is open emergency standby manifold (ESM) isolating valve is closed pressure gauges pressure regulator within specified limits pressure regulator for creep
Test:
Test:
Receiver(s) Examine: general condition security of holding-down bolts condition of delivery isolation valve condition of flexible connections Check: pressure gauges pressure switches operation of non-return valves
Test:
Drainage traps and filters Examine: condition of all filters replace as necessary provision of traps advise accordingly Check: operation of isolation valves pressure differential across filters (where possible) sight glass
77
Control panel Examine: condition of control panel condition of electrical conduits earthing/continuity arrangements Check: electrical connections operation of pressure devices terminal connections cable condition operation of starters and overloads lamps and warning devices operation of duty selector switch operation of auto/manual operating switch operation of main isolation switches
Test:
Exhausts Examine: location potential hazards flexible connections silencers security of bracketing discharge point for blockage Check: drainage traps and flasks empty as required and rectify fault or report remedial action necessary
Vacuum plant system Test: operation of plant record plant settings eg standby pump cut-in pressure etc operation of all warning and alarm systems
78
AVSUs Examine: location cleanliness clean as required Check: correct labelling rectify as necessary orientation of on/off valves valves for ease of operation
Pressure reducing sets Examine: condition of all pressure regulators Check: safety valves security of regulator mounting locking devices where fitted regulators for creep regulators for correct settings
Test:
Terminal units Examine: general condition Check: no leakage occurs when blank probe is inserted or removed repair as necessary identification markings are secure and legible security of mountings operation using test probes gas specificity using gas specific probes pressure with no flow pressure under design flow conditions using calibrated test equipment flow rate
Test:
Pendants/booms Note: the actual tasks required to test the performance of the pendants will depend on the design of the system. In each case, the full range of performance characteristics should be covered. For example, some pneumatically controlled pendants have rotational as well as vertical movement, and this should be tested; the braking system (where applicable) and the fail-safe devices (such as remote controllers) should also be covered. The advice of the manufacturer should be followed. Examine: security of fixings/mountings freedom of movement as applicable labelling and colour coding of hose assemblies Check: leakage hose assemblies security of crimping/ferrules etc condition of hoses replace as necessary terminal units as above
Test:
79
Test:
Area alarms Examine: general condition location and areas served mains electrical supply Check: Test: as for central alarms as for central alarms operation of line pressure sensors
80
Test:
operation of plant from remote controllers appropriate alarm condition is indicated simulated flow failure pressure sensing devices operation of changeover from duty to stand-by on duplex systems
AGS terminal units Examine: general condition location Check: labelling function clean and adjust bobbin assembly or orifice as appropriate correct flow and pressure using calibrated test equipment
Test:
AGS receiving system (where included in contract) Examine: general condition location flexible connecting hoses replace as necessary Check: filter for fluff etc and clean as necessary air inlets are not obstructed correctly labelled operation of flow indicator
Test:
Pressure reducing sets Check: valves for pressure creep safety valves see paragraph 10.124, this volume
Pendants/hose assemblies Check: condition of hoses and hose connections see also note under pendants it may be necessary to dismantle the pendant assembly in order to fully check the hoses.
81
Manifold systems including emergency supply systems Tail-pipes replace Control panel safety valves see paragraph 10.124, this volume
Pressure regulators Check: regulators for pressure creep safety valves see paragraph 10.124, this volume
82
83
Fugure 3a
Fugure 3b
Fugure 3c
84
References
BS 1780: 1985(1992) Specification for bourdon tube pressure and vacuum gauges. BS 1845: 1984 Specification for filler metals for brazing. BS EN ISO 9000 Quality systems. BS 2871 Specification for copper and copper alloys. Tubes. BS EN 60898: 1991 Specification for circuit breakers for overcurrent protection for household and similar installations. BS 4272 Anaesthetic and analgesic machines. Part 3: 1989 Specification for continuous flow anaesthetic machines. BS EN 60947 Specification for low-voltage switchgear and controlgear. BS EN 60947-2: 1996 Circuit-breakers. BS 5169: 1992 Specification for fusion welded steel air receivers. BS 5359: 1976 (1983) Specification for magnetic eleven-disk packs for data processing. Mechanical and magnetic properties. BS 5378 Safety signs and colours. Part 3: 1982 (1995) Specification for additional signs to those given in BS 5378: Part 1. BS 5682: 1984 (1992) Specification for terminal units, hose assemblies and their connectors for use with medical gas pipeline systems. BS 5724 Medical electrical equipment. Part 1 General requirements for safety. Part 2 Particular requirements for safety. Section 2.12: 1990 Specification for lung ventilators. Section 2.13: 1990 Specification for anaesthetic machines. BS 6017: 1981(1989) Specification for copper refinery shapes.
British Standards
BS 7671 Requirements for electrical installations. IEE wiring regulations. 16th edition. BS 88 Cartridge fuses for voltages up to and including 100 V a.c. and 1500 V d.c. BS 89 Direct acting indication analogue electrical measuring instruments and their accessories. BS EN 60042 Guide to steam turbine procurement. BS EN 60045-1: 1993 Guide to steam turbine procurement. BS 341 Transportable gas container valves. BS 6017: 1981 (1989) Specification for copper refinery shapes. BS 1319: 1976 (1986) Specification for medical gas cylinders, valves and yoke connections. BS 1710: 1984 (1991) Specification for identification of pipelines and services.
85
References
BS 6387: 1994 Specification for performance requirements for cables required to maintain circuit integrity under fire conditions. BS 6834: 1987(1992) Specification for active anaesthetic gas scavenging systems. BS 6759 Safety valves. Part 2: 1984 Specification for safety valves for compressed air or inert gases. BS 7226: 1989 Methods of test for performance of inlet air cleaning equipment for internal combustion engines and compressors. EN 1251 Cryogenic vessels transportable vacuum insulated of not more than 1000 litres volume operational requirements.
Miscellaneous publications
Occupations exposure standards for anaesthetic agents (EL(96)33). Department of Health, 1996. Advice on the implementation of the Health and Safety Commissions occupational exposure standards for anaesthetic agents. Department of Health, 1996. Anaesthetic agents: controlling exposure under COSHH. Health Service Advisory Committee. Code of practice 19: Bulk liquid oxygen storage at users premises (Revision 2). British Compressed Gases Association, 1996. Medical gas pipe systems. Design and installation of (QAS 3720.1/206). BSI/Department of Health, 1988. Guidance notes for users of liquid cylinders of low pressure cryogenic liquid supply vessels for liquid oxygen, nitrogen or argon with capacity of under 450 litres (G4521). BOC Gas, 1996.
86
(Given below are details of all Health Technical Memoranda available from HMSO. HTMs marked (*) are currently being revised, those marked () are out of print. Some HTMs in preparation at the time of publication of this HTM are also listed.) 1 2 Anti static precautions: rubber, plastics and fabrics Anti static precautions: flooring in anaesthetising areas (and data processing rooms), 1977. 34 2005 Building management systems, 1996. 6 Protection of condensate systems: filming amines 2007 Electrical services: supply and distribution, 1993. 8 2009 Pneumatic air tube transport systems, 1995. 2010 Sterilizers, 1994, 1995, 1997 2011 Emergency electrical services, 1993. 12 to 13 2014 Abatement of electrical interference, 1993. 2015 Bedhead services, 1994, 1995. 16 17 Health building engineering installations: commissioning and associated activities, 1978. 18 Facsimile telegraphy: possible applications in DGHs 19 Facsimile telegraphy: the transmission of pathology reports within a hospital a case study 2020 Electrical safety code for low voltage systems, 1993. 2021 Electrical safety code for high voltage systems, 1993, 1994. 2023 Access and accommodation for engineering services, 1995. 2024 Lifts, 1995. 2025 Ventilation in healthcare premises, 1994. 26 Commissioning of oil, gas and dual fired boilers: with notes on design, operation and maintenance 2027 Hot and cold water supply, storage and mains services, 1995. 28 to 29 2030 Washer-disinfectors, 1995. 32 to 34 36 to 39 2040 The control of legionellae in healthcare premises a code of practice, 1993. 4144 2045 Acoustics, 1996. 4649 2050 Risk management in the NHS estate, 1994. 5154 2055 Telecommunications (telephone exchanges), 1994. 2066 Supply and treatment of water 2065 Healthcare waste management segregation of waste streams in clinical areas
2070 Estates emergency and contingency planning 2075 Clinical waste disposal alternative technologies Component Data Base (HTMs 54 to 80) 54.1 User manual, 1993. 55 Windows, 1989. 56 Partitions, 1989. 57 Internal glazing, 1995. 58 Internal doorsets, 1989. 59 Ironmongery 60 Ceilings, 1989. 61 Flooring, 1995. 62 Demountable storage systems, 1989. 63 Fitted storage systems, 1989. 64 Sanitary assemblies, 1995. 65 Health signs* 66 Cubicle curtain track, 1989. 67 Laboratory fitting-out system, 1993. 68 Ducts and panel assemblies, 1993. 69 Protection, 1993. 70 Fixings, 1993. 71 Materials management modular system* 72 to 80 Firecode 81 82 83 85 86 87 88 Firecode: fire precautions in new hospitals, 1996. Firecode: alarm and detection systems, 1989. Fire safety in healthcare premises: general fire precautions, 1994. Firecode: fire precautions in existing hospitals, 1994. Firecode: fire risk assessment in hospitals, 1994. Firecode: textiles and furniture, 1993. Fire safety in health care premises: guide to fire precautions in NHS housing in the community for mentally handicapped/ill people, 1986.
Health Technical Memoranda published by HMSO can be purchased from HMSO bookshops in London (post orders to PO Box 276, SW8 5DT), Edinburgh, Belfast, Cardiff, Manchester, Birmingham and Bristol, or through good booksellers. HMSO provide a copy service for publications which are out of print; and a standing order service. Enquiries about Health Technical Memoranda (but not orders) should be addressed to: NHS Estates, Department of Health, Publications Unit, 1 Trevelyan Square, Boar Lane, Leeds LS1 6AE.
87
88