Following IHEEM’s work to strengthen and promote the role and importance of professional development and independent AEs across all its specialist engineering platforms, members highlighted the urgent need to actively support the development of AP and CPs. IHEEM’s Decontamination Technical Platform is now piloting a programme in Wales aimed at directly supporting such personnel. John Prendergast, an IHEEMregistered AE(D) leading the pilot, discusses the wider issue of engineering governance in healthcare facilities, and ongoing work to ensure that engineers at all levels are competent.
Engineering governance is a requirement to support the various healthcare services/ sectors across the United Kingdom (both public and private sector). One of the real concerns as regards governance is that engineering issues in hospitals and other healthcare facilities need to be addressed in accordance with relevant HTMs and standards. Equally, good governance needs to clearly establish and present the specification for the competency levels of the personnel responsible for the environment and equipment. This is becoming ever more complicated and technical.
Historically, hospitals and manufacturing plants have had engineers on site, trained and educated through industrial apprenticeships, with high skill levels, and – in the case of the former – able to maintain all the types of plant that hospital Estates teams and departments are responsible for. Today, however, a number of important questions arise, including:
1 Currently the various HTMs in use across the UK specify defined levels of accountability – from the CP(D) to the AE(D). Are engineers at all these levels trained and educated appropriately to conduct their tasks?
2 Do they have experience and appropriate skill levels and knowledge for the job in hand?
3 Should there be a base level requirement for engineers undertaking service, breakdown, and validation activities? Are they trained appropriately in mechanical or electrical disciplines in accordance with health and safety requirements?
4 HTM 2010 and other historical publications have presented guidelines on the educational standards and experience needs for healthcare engineers; should there be similar guidance for all, with recommendations instated today?
In parallel, and as with other industries, the NHS, support service providers, and commercial manufacturers – e.g. businesses operating in the medical device and pharmaceutical sectors, are currently finding significant skill shortages, in terms of many engineers who work on equipment. Experience is highlighting a huge variance both in the performance standards and understanding of engineers appearing within healthcare premises to conduct the designated tasks and work.
Where, though, does the problem lie? Some of the key factors include:
A lack of education standards at the outset of work. (e.g. apprenticeships or college courses).
Insufficient Continuing Professional Development.
Engineers taking job opportunities outside their skills matrix, often with no apprenticeship to support the basic theories of engineering.
Training structures within the healthcare sector not aligned to current demands and equipment.
Lack of supervision or competency assessment by estate and facility management personnel. Often this is because of the lack of an AP(D), or no communication with the AE(D).
Organisations seeking the cheapest solution, without considering quality or consistency of service.
Insufficient evidence presented to clients to confirm competencies.
Competencies that may not include specific activities shown in the generic CP(D) role – e.g. a maintenance engineer with no validation experience, or vice versa
Where is the current drive?
The current issues around competency are possibly due to a combination of the above, plus the generic problem that the engineering industry does not promote technical apprenticeships as it did in the past. Recent years have seen a drive to promote such development, but will it focus on the core technical skills our sector needs, or should the decontamination industry look at improvements from within?
HTM 00 specifies that competent persons must demonstrate a sound trade background and specific skills in the specialist service they are working within. As Authorised Persons, can we be confident that this is the case every time a CP(D) undertakes work within our premises?
The IHEEM AE(D) Registration Board monitors all IHEEM-registered AE(D)s every three years, with a detailed review and CPD log assessment. Systems are in place to ensure that the standards and skill levels are supported to the requirements of the Engineering Council. In fact the Engineering Council now checks the CPD records of IHEEM members on an annual basis, and AEs are checked for levels of working along with all other members. A similar system should be considered for the AP(D) and CP(D) roles, although it is acknowledged that the practicalities would need thinking through
As Authorising Engineers, can we improve the standards, check for evidence, improve monitoring, support the service, and subsequently reduce the risk to the patient? As AEs, we must ensure that we advise our clients correctly, promoting the highest of standards, and escalating any concerns to the executive boards of the organisations we represent. We must work with site/facility-based partners to ensure that systems are managed in accordance with best practice, healthcare guidance, good manufacturing practices, health and safety, and the medical device regulatory framework
Each site/facility/manufacturing premises should have Authorised Person services available. The AP(D) should be appointed in accordance with the HTM/ WHTM/SHTM guidance. The persons filling this role must manage the tasks appropriately, and not merely adopt a ‘tick box’ approach. If the AE(D) is not satisfied that the AP(D) is managing the safety systems correctly, constructive help should be given. The registration board for AE(D)s has produced guidance on the appointment procedures
AP(D)’s responsibilities
The AP(D), as nominated responsible person, 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 (ref HTM 00 and HTM 01-01 part A). A permit to work should be used, to ensure that all engineering activities are managed and traced. The AP(D) should review job-sheets/logbooks presented by any internal/external engineering providers, with no shortcuts allowed
Engineers (Competent Persons) should not work on any equipment unless adequately trained in the discipline for which they are needed. Should we accept manufacturers or third-party providers as the experts? No, they must present the same robust documentation as any internal staff members. Manufacturers/ third-party providers can have a high staff turnover, which can lead to inconsistent service delivery and skills levels
A competent person, in accordance with HTM 00, is a person that supplies skilled installation and/or maintenance of the specialist service. The CP(D) will be appointed, or authorised to work, by the appointed AP(D). They should be able to demonstrate a sound trade background, and specific skill in the specialist service. They will work under the direction of the AP(D), following the operating procedures, policies, and standards of the service (ref HTM 00 and HTM 01-01 Part A). Documentation presented to the AP(D) should include evidence of training appropriate to the equipment and tasks. Does this mean that a quarterly validation course is suitable for maintenance activity?
What should we do if we consider that the person nominated is not assessed to be competent, or to possess sufficient experience? The first response would be a recommendation for refresher training and education. Often managers send their staff on courses, but fail to correlate the fact that issued guidance (both local and national), equipment, and technology, change frequently. Part of the manager’s task should be to review the relevant courses attended, and, if – on doing this – it is found that they were conducted based on on ‘old’ guidance, then refreshers are to be recommended. This will include safety requirements within the designated workplaces
Those operating in commercial / industry sectors, such as pharmaceutical manufacturers, have historically managed their activities in alignment with HTM guidance. It is acknowledged that many of the points highlighted in this paper are difficult to follow for such commercial suppliers, and revised HTMs have not considered the specific implications in some of these areas. It is advised that those in the commercial sector endeavour to work within the HTM principles, using specialist expertise, such as that of AE(D)s, to support and improve practice, and identify any applicable limitations in the governance.
Conclusions
Where do these concerns leave us, and what can we do – as AEs and as other professionals associated with healthcare engineering – to minimise risks? As AEs we must promote regular training and review organisational plans as part of routine assessments/annual reports
The AE must work with the AP to ensure that documentation is correct within the organisation, to include a review of CP competency assessments, equipment registers, maintenance logbooks, permit to work protocols, and validation reports etc.
We must also promote concise communication across the system, so that all involved have an understanding of who is responsible for which action, and escalation of any concerns found, and a determination of any action plan needed in accordance with safe systems of work.
Such discussions must include relevant roles named within HTM 01-01 Part A.
As providers of services, we must invest in education and courses for our CPs. They are an asset, and if trained appropriately, can reduce costs and enhance patient safety. There needs to be routine CPD training to cover specific topics such as steam principles, calibration, chemical disinfectants, and our problem area – rinse water quality. As an industry which includes medical device sectors, along with commercial entities such as pharmaceutical production units, we have much to think about, and we need to evolve training to meet everchanging needs. HTM guidance, specific to decontamination requirements for training, should align with other guidance within healthcare, such as HTM 02-01: Medical gas pipeline systems.
Are current industry/commercial standards different to those in healthcare, and – in compliance with health and safety accountability – should such standards be consistent? Also, as a Technical Platform (Decontamination), should we work to embrace consistent protocols and governance guidance?
The CP(D) and AP(D) certification process must ensure that individuals understand the principles behind the development, validation, and control of the decontamination/sterilisation process.
They must also have an awareness of the operational management and implementation of relevant regulatory guidance and standards. There is a need to specify a refresher training timescale for CP(D)s and AP(D)s. This would provide the industry with a governance structure that ensures that the relevant personnel are suitably trained and conversant with changes to HTM guidance
Competent Persons (Decontamination)
To be deemed a CP(D), the engineer must demonstrate that they have a minimum 12-months’ experience working on relevant decontamination equipment; this must include the theoretical background of sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc.
CP(D)s should:
Have completed a relevant apprenticeship, or equivalent training, in mechanical, electrical, or electronic disciplines. This must include core experience with electrical safety, steam, and water systems.
Understand microbiological, chemistry, and infection control principles, appropriate to the systems they are working on. Such an understanding should be supported by attendance at relevant training, such as seminars or webinars applicable to the duties they are expected to complete. This may include items such as aseptic water sampling techniques, and awareness of the importance of water quality, and/or chemical purity of steam etc.
Have completed a minimum NVQ level 3, City & Guilds, or BTEC qualification, or equivalent, in mechanical, electrical, or electronic disciplines
Have completed and passed accredited training courses covering validation of relevant decontamination/ sterilisation equipment. This can include sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc. This training is considered relevant only if undertaken within 10 years of assessment
Have completed training courses provided by manufacturers of decontamination equipment. This training is considered relevant only if undertaken within 10 years of assessment. Such training must include general maintenance and/or fault finding of equipment installed.
Have routinely completed a competency logbook documenting a reflective work journal. A registered AP(D), an IHEEM-registered AE(D), or the appropriate service manager, must routinely assess the logbook
Undertake a routine CPD programme. The programme should equate to 10 hours of relevant CPD per calendar year. Such a programme may include training specific to the role or the sector; for example this may include an awareness of good manufacturing practices where CP(D)s are dedicated to working within the pharmaceutical sector.
Be assessed and considered competent by an IHEEM-registered AP(D) at a frequency not exceeding a 5-year period.
It is acknowledged that engineers may complete restricted work activities under the AP(D)’s scrutiny, and – at their discretion – during a training period and prior to acceptance as a CP(D)
Authorised Persons (Decontamination) AP(D)s, meanwhile, should:
Have a minimum 12 months’ experience of relevant decontamination equipment. This can include sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc.
Have completed a relevant apprenticeship, or equivalent, in mechanical, electrical, or electronic disciplines, and have core experience with electrical safety, steam, and water systems.
Have completed an NVQ level 3, City & Guilds, or BTEC qualification in mechanical, electrical, or electronic disciplines. It is advisable if the person in this the role is working towards, or has completed, a Higher National Certificate in an Engineering discipline.
Have completed and passed accredited training courses covering validation of relevant decontamination equipment. This can include sterilisers (porous load, laboratory, pharmaceutical, benchtops, VHP etc), washer-disinfectors (thermal, chemical), and controlled environment storage equipment etc. This training is considered relevant only if undertaken within 10 years of assessment.
Completed an accredited training course for the Authorised Person (Decontamination) role. This training is considered relevant only if undertaken within 10 years of assessment period.
Undertake a routine CPD programme. The programme should equate to 15 hours of relevant CPD per calendar year.
Preferably be employed within a supervisory or management role within the organisation they represent. If the nominated AP(D) is occupying a role in accord with those highlighted in this guidance, the AE(D) must be assured that the individual has appropriate knowledge of the role, and the equipment/systems/structures they are responsible for.
Be assessed and considered competent by an IHEEM-registered AE(D) within a 3-year period.
Have relevant experience and knowledge of the sites for which the AP(D) is responsible. This must include periodic attendance at the site to verify that equipment and systems are functioning in line with the requirements of HTM 01-01 Part A and HTM 00.
Understand microbiology, infection prevention and control, and other ancillary services applicable to the equipment serving the decontamination facility. This may include enhanced awareness of the microbiological impact of water/ventilation principles within systems, or innovative technologies being developed to decontaminate medical devices.
Understand health and safety, legislative, and regulatory requirements; this may include completion of training to cover PSSR, and COSHH requirements etc.
Have satisfactory awareness and knowledge of risk assessment processes and escalation strategies.
It is acknowledged that the AP(D) may not be solely dedicated to the role; it may only form part of the individual’s core duties, but they must give the role the necessary due diligence, and be allocated enough resource to complete the core governance duties in accordance with the operational policy of the organisation they represent. The AE(D) must assess this as part of the assessment process.
Where the AP(D) services are outsourced, the nominated individual must be independent of the systems they are responsible for, and must be appointed as specified in HTM 00 and HTM 01-01 Part A. Even when responsibilities are outsourced, the AP(D) must always demonstrate a basic awareness of the site/premises/systems they are accountable for, and must attend site at routine frequencies.
When individuals are completing the AP(D) duties with acknowledged limitations, these need to be documented and approved by the AE(D). Details of any person taking responsibility for derogations to support their role should be documented and recorded up to the organisation lead/ director.
It is acknowledged that there may be resource issues for a single AP(D) working within one organisation. Discussions must be sought with the AE(D) responsible on systems to agree support to manage the governance. This may include support from other Responsible Persons that have experience managing permit to work/ control of contractor’s systems on behalf of the organisation
John Prendergast
John Prendergast is the Senior Decontamination Engineer working within the specialist team at NHS Wales Shared Services Partnership/ Specialist Estates Services. His role is dedicated to all aspects of decontamination/reprocessing techniques of medical devices. He leads the team that provides validation services, advice, and guidance to Health Boards/Trusts within Wales, and works closely with Welsh government departments to deliver policy and strategy in this unique and often complex field. John has worked within the NHS in Wales for the past 37 years. In 2012 he completed the ACIST course (qualifying course for Authorised Engineer – Decontamination), and was formally accepted onto the IHEEM register as an Authorised Engineer (Decontamination) in 2013. He is Chair of the IHEEM Welsh Branch, and represents Wales on the IHEEM AE(D) Registration Board.