General Note

NHS Fife acknowledges and agrees with the importance of regular and timely review of policy statements and aims to review policies within the timescales set out. New policies will be subject to a review date of no more than 1 year from the date of first issue.

Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than 3 years.

If a policy is past its review date, then the content will remain extant until such time as the policy review is complete and the new version published, or if national policy or legislative changes are made

1. FUNCTION

1.1 To ensure that medical gases including Liquid Nitrogen are handled, stored, administered and maintained safely within all hospitals and departments of NHS Fife and in non-NHS Fife settings where NHS Fife staff store or administer medical gases.

1.2 This policy applies to the supply, delivery, installation, and maintenance of the medical gas service from the point of supply, up to and including the terminal outlets, the medical gas cylinders, and regulators.

2. LOCATION

2.1 Applicable in all locations where medical gas and Liquid Nitrogen is stored, transported, used, and administered within NHS Fife.

3. RESPONSIBILITY

3.1 The Chief Executive

3.1.1 The NHS Fife Chief Executive has ultimate responsibility for medical gases and liquid nitrogen, including the allocation of resources and the appointment of personnel and will appoint a sufficient number of Authorised Persons - Medical Gas Pipeline System (AP(MGPS)) in writing, necessary to manage the MGPS safely and effectively. The appointments of AP(MGPS) are undertaken via the concession manager for the Phase 3 building (Victoria Hospital) following completion of approved training and assessment and recommendation of suitability via the Authorising Engineer.

3.1.2 The appointment of AP(MGPS) will be on the recommendation of the Authorising Engineer (MGPS) with specialist knowledge of MGPS.

3.2 Pharmacy Responsibility

3.2.1 The NHS Fife Director of Pharmacy and Medicines has the delegated overall responsibility for medical gases within NHS Fife and medical gases will be subject to the same quality control requirements as other medicines.

3.2.2 In addition to the QC requirements the Director of Pharmacy and Medicines holds ultimate responsibility for maintaining a register of Certificates of Analysis for medical liquid oxygen delivered

3.2.3 By retention of Certificates of Conformity, the pharmacy department must ensure that cylinder gases comply with Ph.Eur requirements and that all other gases and gas mixtures comply with the manufacturers ‘product licences and that medical gases manufactured on site meet quality control requirements.

3.2.4 Pharmacy is responsible for the purchasing function of medical gases. Responsibility for placing orders with pharmacy is delegated to Estates/Hotel services.

3.3 Authorising Engineer (MGPS)

3.3.1 The Authorising Engineer (MGPS) (AE(MGPS)) must be appointed in writing by the Chief Executive and must be suitably qualified in accordance with Scottish Health and Technical Memorandum (SHTM) 02-01.

3.3.2 The duties and responsibilities of the Authorising Engineer (MGPS) include:-

• Recommending to the Chief Executive those persons who, through individual assessment, are suitable to be AE(MGPS)

• Ensuring that all AE(MGPS) have satisfactorily completed an appropriate training course before appointment and are re-assessed every three years and have attended a refresher, or other training course, prior to such re-assessment

• Carry out an annual audit of documentation, plant and distribution system and provide this to the senior executive with assigned MGPS responsibilities

• As required, provide professional, technical and contractual advice to NHS Fife in accordance with SHTM 02-01

• To monitor the implementation of operational policies and procedures

3.4 Authorised Person (MGPS) (AP(MGPS))

3.4.1 An Authorised Person (MGPS) is a person who has sufficient technical knowledge, training and experience in order to understand fully the hazards and risks posed by a medical gas pipeline system and who is appointed in writing by the executive manager on the recommendation of an authorised engineer with specialist knowledge of MGPS. The certificate of appointment must 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.

3.4.2 They are responsible for the day to day management of the MGPS and for ensuring that NHS Fife MGPS maintenance specification and schedule of equipment (including all plant, manifolds, pipe work, valves, terminal units and alarm systems) are kept up to date, and for ensuring it is operated safely and efficiently in accordance with statutory requirements and guidelines.

3.4.3 The AP(MGPS) must have read, understood and be able to apply the guidance in SHTM 02-01, especially in relation to validation and verification, and must also be completely familiar with the medical gases pipe routes, their means of isolation and the central plant. He/she must ensure that the work described in any permit-to-work is carried out to the necessary standards. They must ensure all documentation is kept in accordance with SHTM 02-01.

3.4.4 It is the duty of the AP(MGPS) to liaise with the Designated Nursing Officer (DNO) on any limits of involvement in the isolation of sections of the MGPS during an emergency. Liaising with DNO, the Quality Controller (MGPS) and others, who need to be informed of any interruption or testing of the MGPS as a result of any work carried out.

3.4.5 The AP(MGPS) supervises work carried out by Competent Persons (MGPS) and ensures the standard of that work, including obtaining method statements and risk assessments from contractors.

3.4.6 The AP(MGPS) must organise training of Estates staff and other staff as required and /or transfer of MGPS information as is needed for the efficient and safe operation of the MGPS.

3.5 Competent Person (MGPS) (CP(MGPS))

3.5.1 The Competent Person is the person who carries out the installation and/or maintenance. They must have received appropriate training and must be registered to BS EN ISO 9001/BS EN ISO 13458 in accordance with SHTM 02-01.

3.5.2 The duties and responsibilities of a (CP(MGPS)) as NHS employees or appointed specialist contractors are:-

• Performing repairs (planned and emergency), alterations or extensions, as directed by the AP(MGPS), in accordance with the Permit to Work System and SHTM02-01
• Performing engineering tests appropriate to all work carried out and informing the AP(MGPS) and provide copies of all test results and update of drawings to include system modifications
• Carrying out all work in accordance with the relevant national legislation / guidance and NHS Fife policies
• Providing appropriate method statements and risk assessments to NHS Fife Estates Department and /or VHK Phase 3, EQUANS helpdesk (ext. 29292, option 2)

3.6 Quality Controller (MGPS)

3.6.1 The Quality Controller (QC(MGPS)) is an appropriately trained person appointed by the Chief Executive on the recommendation of the Director of Pharmacy and Medicines. Appropriately trained Pharmacy staff may carry out some tasks designated by the QC(MGPS).

3.6.2 The duties and responsibilities of the QC(MGPS) are:-

• Assuming responsibility of the quality control of the medical gases at the terminal units and plant.
• Liaising with the AP(MGPS), in order to carry out specific quality and identity tests on the MGPS (including quarterly checks on medical air) in accordance with the Permit to Work System and relevant quality/European Pharmacopoeia (Ph.Eur.) standards.
• To organise MGPS training for pharmacy staff who may deputise for the QC(MGPS)

3.7 Designated Nursing Officer DNO (MGPS)

3.7.1 The DNO is a Senior Nurse, for example, clinical nurse manager/lead nurse/ Manager / Head of Nursing and clinical coordinator with whom the AP(MGPS) liaises on any matters affecting the MGPS.

3.7.2 For the purposes of MGPS work at ward level, the clinical Nurse Manager / head of nursing will have jurisdiction over most MGPS work to be carried out and sign the relevant Permit to Work issued by the AP(MGPS). This will include all planned and emergency local work in normal working hours.

3.7.3 In the event of a planned interruption involving more than one ward, e.g. for a major shutdown, the DNO will be consulted. The person assuming this responsibility will liaise with other clinical staff as necessary.

3.7.4 DNO(MGPS) must have undertaken appropriate training as required by this policy.

3.7.5 Senior Nurse Managers must ensure appropriate DNO cover, and arrangements are in place 24 hours a day in areas where there are Medical Gas pipelines. For example, in the out of hours period this may be delegated to the on-call manager with the responsibility to delegate to the Senior Nurse on-duty or clinical co-ordinator should a clinician be required.

3.8 Designated Porters (MGPS)

3.8.1 Designated Porter (DP(MGPS)) is the Porter in charge, having particular responsibilities for medical gases.

3.8.2 He/she will have undergone specialist training in medical gas safety, cylinder identification and safe handling and storage of medical gas cylinders, including relevant manual handling training (cylinders).

3.8.3 DP(MGPS) are not subject to the MGPS permit to Work System and must, therefore, NEVER PERFORM UNCONTROLLED ISOLATION OF A MGPS. Their training must reflect this requirement. All training must be documented, and records kept by departmental line managers.

3.8.4 It is essential that DP(MGPS) work safely at all times, using the appropriate Personal Protective and Manual Handling Equipment. The non-wearing of safety/PPE could invalidate any claims for any personal injuries received while performing medical gas duties.

3.8.5 Personal protective or manual handling equipment will be supplied by the Hotel Services Department, and any found to be missing, or defective in any way, must be reported immediately to a Line Manager by the Designated Person.

3.8.6 For the purposes of this Policy, Line Managers may allocate DP(MGPS) to Pharmacy, Theatres and General areas respectively. In these instances, specific training in departmental techniques may be necessary.

3.8.7 DPs assist in the delivery of medical gas cylinders in all areas of NHS Fife – providing full gas cylinders and returning empty gas cylinders the medical gas store in accordance with NHS Fife Procedure for Medical Gas Cylinders

3.8.8 Appropriately trained DPs attach and remove cylinders from medical equipment regulators and manifold tailpipes.

3.8.9 DPs perform a minimum of a weekly check on cylinders and inform pharmacy of any deficiencies or stock orders required.

3.9 Health Care Professionals who administer Medical Gases/Oxygen

3.9.1 It is the responsibility of all health care professionals administering medical gases to ensure they have had suitable training (see section 4 –Training) and are competent in all appropriate aspects of handling and administration of medical gases.

3.9.2 Medical gases should be considered as medicines and must be prescribed. It is the responsibility of all healthcare staff administering medical gases to ensure that it is prescribed on the Kardex or other prescription document before it is administered. See Safe and Secure Use of Medicines Policy and Procedures for details about administering Oxygen in an emergency.

3.9.3 Staff must ensure that they have selected the correct medical gas and the correct equipment before administration of a medical gas.

3.9.4 It is the responsibility of the nurse in charge of each ward and department to ensure an adequate back up supply of medical gas in cylinder form is available for use in the event of an emergency. This can be done in partnership with the Pharmacy team.

3.9.5 Theatre co-ordinator must ensure that there are suitable back up measures in place for anaesthetic machines.

3.10 Medical Gas Committee (MGC)

3.10.1 The Medical Gas Committee (which shall report to the NHS Fife Area Drug and Therapeutics Committee) shall consist of a minimum of:-
• Senior AP(MGPS)
• Chief Pharmacist (or their representative),
• A nominated Designated Nursing Officer / Senior Nurse Manager
• Health and Safety Advisor
• Portering Manager or their deputy.
• Authorising Engineer (MGPS)
• Quality Controller or their deputy

3.10.2 The MGC will be responsible for reviewing the Medical Gas Policy and ensuring its implementation. It will also raise awareness of training issues and, where applicable, take decisions appertaining to the use of medical gases and any equipment that may require a medical gas supply taking full account of the risks involved.

4. TRAINING

4.1 In order to ensure the safety of patients, clinical and nursing staff, maintenance personnel, porters and other users of medical gases, it is essential that only those people that are properly trained and supervised in the use of MGPS, cylinders or equipment be allowed to use them.

4.2 Responsibility for ensuring that training is carried out is defined in Table 1 below. Records of such training must be kept by the appropriate manager and where required by the individual themselves.

It is the responsibility of departmental managers to ensure all staff are appropriately trained.

4.3 Training is provided through taught sessions or on-line via TURAS it is competence assessed.

Table 1 - Training Schedules for Staff Working with

MEDICAL GAS PIPELINES

 Table 2 -   Training Schedules for Staff Working with

MEDICAL GAS CYLINDERS ONLY

5. RISK MANAGEMENT

5.1 A local risk assessment of all areas where medical gases are used and stored must be carried out at least annually and when any significant changes are made to use or storage of medical gases in those areas. This assessment must be carried out by the department user assisted by Pharmacy and Estates as required. The regular risk assessments will be reported as part of the annual NHS Fife Medical Gas Audit.

A copy of the local risk assessment must be kept at ward level.

5.2 All staff involved in the maintenance, storing, handling and administration of medical gas must have suitable training, and be aware of the hazards associated with the use of medical gases, and the importance of managing the risks posed by these.

5.3 A DATIX must be completed for any incident or near-miss in any part of the process involving medical gases in pipelines or cylinders.

5.4 Where an NHS Patient Safety Alert has been issued in relation to any aspect of medical gases, it is the responsibility of NHS Fife Pharmacy to work with Estates teams to ensure that all necessary staff have been informed and that all appropriate action is taken.

6. RELATED DOCUMENTS

6.1 NHS Fife Policy GP/M1 – Manual Handling

6.2 NHS Fife Policy GP/M3-1 - Procedure for Medical Gas Cylinders

6.3 NHS Fife Policy GP/M3-2 – Procedure for Medical Gas Pipeline Systems

6.4 NHS Fife Policy GP/M3-3 - Procedure for the Safe Storage, Use and Transport of Liquid Nitrogen

6.5 NHS Fife Safe and Secure Use of Medicines Policy and Procedures (SSUMPP)

7. REFERENCES

7.1 The Human Medicines Regulations 2012

7.2 Scottish Health and Technical Memorandum SHTM 02-01

7.3 NHS Fife Adverse Events Policy, GP/19. V4.

7.4 BS EN ISO 9001, Quality Management Systems, 2000

7.5 BS EN ISO 13458, Medical Device Quality Management