Foundation Standard

The Ministry of Health has replaced AS/NZ 4815:2006 with a new Australian standard, AS 5369:2023 for the reprocessing of reusable medical devices (RMDs), such as surgical instruments and equipment. This change has implications for practices that reprocess their own or outsource the reprocessing of RMDs. Practices that use disposable medical devices, will not be affected.

Evidence to provide if a practice is reprocessing RMDs:

1. A detailed policy and procedure, that aligns with the College’s Policy and Procedure guide for reprocessing RMDs: RNZCGP policy and procedure guide for reprocessing RMDs
2. A description of the site where reprocessing takes place, ensure the environment and facility design meets the requirements of the new standard.
   1. There must be effective segregation of clean and dirty activities to minimise the risk of cross-contamination.
   2. Hand hygiene basins should not be in clean work areas because they can be a source of contamination. An alcohol-based hand gel can be used instead if needed.
   3. Ventilation – discuss design and operation of ventilation systems at the site.
   4. There must be a uni-directional workflow, from dirty to clean areas allowing effective segregation of clean and dirty activities.
3. A process map or flow diagram which ensures the risks of cross contamination, including airflows are effectively managed. Example of a process map of workflow.
4. Evidence of risk assessments and a risk-based approach to reprocessing RMDs.
   1. Do a risk analysis – identify safety risks and potentially hazardous situations linked to reprocessing RMDs and document these in your practices hazard and risk register.
   2. Mitigate the risks where possible.
   3. Evaluate and review the risks at least annually.
   4. Incidents, process breaches, failures or non-compliance and near misses need to be reported in your practices incident management system.
   5. Undertake improvement activities based on incidents.
5. Staff members who reprocess RMDs need to update their infection control training to align with the new AS 5369:2023 standard.

Training suggestions are found on the RNZCGP webpage. Ko Awatea Learn Online also has multiple infection control modules. 

1. Evidence that the practice monitors the effectiveness of each sterilisation cycle.
2. Evidence that the steriliser has current calibration and validation certificates.

For further information: 12.1 Infection control | RNZCGP

Contact the nursing team nursing@pinnacle.health.nz if you have any questions.

The RNZCGP has released new guidance around residual current devices (RCDs) and body protected areas (BPAs) in general practice.

AS/NZS 3003 is legally mandated in healthcare settings under Electricity (Safety) Regulations 2010, practices using mains-powered medical equipment or devices on patients must install Residual Current Devices (RCDs) within a designated body protected area.

For practices who connect patients to medical equipment or devices via mains power, outside of a certified body protected area, the College strongly recommends that they:

• develop a transition plan to install a designated Body Protected Area, or
• install a designated body protected area.

Pinnacle can support you to understand the requirements and develop transition plans, please contact Lisa Zame or Michelle Bayley. Some practices may also be eligible to apply for the facility development fund.

How to determine if your practice needs to take any actions

Does your practice have a body protected area already?

No – determine if a body protected area is required and create a transition plan.

Yes – ensure your body protected area is compliant and displays the correct signage with details of the most recent safety inspection.

Does your practice use mains-powered medical equipment or devices on patients?

(E.g. otoscopes with mains-power, ECGs that are not battery operated, diathermy machines used in minor surgery, suction equipment, spirometry equipment, ultrasound machines, electrocautery units, nebulisers?)

No – your practice doesn’t need to do anything.

Yes – your practice needs a designated body protected area. Create a transition plan and consider technical requirements and economic installation methods. Depending on the size of your practice and the types of procedures/treatments that you offer, you may need more than one body protected area. All power points in the body protected area must be RCDs (also see guidance about separate power points for cleaning purposes).

Does your practice use electric beds?

No – your practice doesn’t need to do anything.

Yes – document what each space/room in your practice is used for – if electric beds are used for consultation and examinations only, then they are exempt from body protected areas. If electric beds are used for treatment then the space/room must be body protected.

Does your practice have RCDs in consult rooms or body protected areas?

No – no action is required. (If you do not have RCDs, this means your practice does not have a body protected area and does not use any mains-powered electrical equipment that touches a patient.)

Yes – ensure your RCDs are inspected by an electrician annually and in-house RCD tests are performed every six months to ensure they trip correctly, and maintenance records are up to date.

More information about body protected areas and RCDs can be found on the College website.

Once the assessor has completed the Foundation Standard site visit, they inform the practice if any further actions or evidence is needed to meet the requirements. This time period is referred to as the ‘post assessment dialogue’ (PAD) phase. 

The PAD phase should take between 2-6 weeks, and it is expected that all evidence is current when the assessment is submitted to the College. A longer PAD phase can cause timebound evidence to expire, creating additional work for both practices and assessors as they identify and refresh the expired pieces of evidence. 

To improve efficiency and resolve this issue, the College introduced the subject in the August 2024 Quality Pānui, of implementing a PAD limit of 3 months, effective from 1 January 2025. 

Since January, the College have observed that the number of assessments being submitted outside the PAD time frame has continued to increase. 

From 1 June 2025 the College will be implementing the following process for all Foundation Standard assessments submitted that exceed the 3-month PAD limit: 

• the certification process (including moderation) will not be progressed until they have received verification from the assessor that all time bound evidence has been checked and is current
• the practice’s primary contact and the assessor will be notified that the PAD limit has been exceeded
• the practice and the assessor (separately) will be asked to complete a survey detailing reasons for exceeding the 3-month limit within 5 working days
• the assessor will be asked to validate the currency of the attached evidence.

If you have any questions, please contact Michelle Bayley, details below.

Esteem Healthcare Essential Sterilisation Workshop

• Advertised as AS 5369:2023 compliant.
• Endorsed by RNZCGP & NZNC.
• Compliant with Cornerstone/Foundation assessment.

Summary of content: Correct cleaning, processing and packaging of instruments to ensure sterility. See flyer here. 

Cost: $350 + GST per practice (group learning onsite, 60-minute duration) 

Acehub online education

• Sterilisation basics.
• Advertised to meet indicator 12.1 infection control of the Foundation Standard (Meet standard NZS 8134:2021 and AS/NZS 4815:2006) v.

Summary of content: How to clean reusable devices, how to inspect and seal packs, autoclave process for benchtop sterilisation machines, how to care for instruments, chemicals and detergents.

Cost: $65 + GST 2hrs on demand online learning. Acehub also have another module on removing biofilm and market both courses as a bundle for $75 + GST. 

Equipment supplier training

Suppliers of autoclaves and autoclave equipment often provide education to practices on the equipment they have purchased e.g. Amtec, 3M, EBOS etc. Practices will be required to liaise directly with their suppliers to confirm availability of this.

The only two audits required as evidence for Foundation Standard are:

• Indicator 9.1: repeat prescribing
• Indicator 9.3: medicines reconciliation. 

These audits ensure a practice’s policies and procedures are current and being adhered to. 

After completion it is important to discuss findings at your next clinical governance meeting. This can occur after the assessment, just note it.

See the sample template for repeat prescribing audit and the sample template for medicines reconciliation audit.

Despite the increase in immunisation providers outside general practice since COVID-19, general practice continues to be the service that facilitates the majority of childhood immunisations. A good process that identifies roles and responsibilities, timing and method of inviting (recalling) whānau for immunisation can improve coverage for the practice, with the ultimate health gain of fewer vaccine-preventable illnesses in patients and whānau.

As part of Foundation Standard criteria 7.2, practices are required to have a documented process on how recalls are undertaken in general practice. The areas that need to be covered in the standard are outlined in this process. Pinnacle has put together a process for practices to use/amend that covers those areas (see the files section below). Your nurse leads and child immunisation improvement nurse are always available if you have any questions about immunisation or practice recall process nursing@pinnacle.health.nz

All practices must comply with the PHO enrolment requirements when enrolling patients. These are summarised on our website, including a useful video for practices presented by Te Whatu Ora. 

Through Foundation Standard assessments and discussions with Te Whatu Ora Health Payments Integrity Unit, the following points may be of interest.

• Enrolment form - ensure your enrolment form is up-to-date. Key areas of focus include: 
  • patients enrol with Midlands Health Trust not Pinnacle or MHN
  • there are certain criteria that have changed since the last enrolment form. In particular, the new question around gender, and the information around the national patient experience survey. Please ensure both of these are clearly displayed on your enrolment form if you are using your own form (not the Pinnacle one).
• Having a process to regularly audit your enrolment process can identify any gaps before you have an audit. Use the random 100 NHIs that are sent to you quarterly via your Healthlink folder for this purpose.
• Ensure you have a documented enrolment procedure and that all staff are aware of this. Information around what is required can be found on our website and in the guidance under the RNZCGP foundation standard criteria 2.2. 
• Ensure the date of enrolment on the enrolment form, and in your practice management system, match.
• Ensure ethnicity is recorded correctly.

Through the foundation standard assessment process a few gaps have been noted around the management of hazardous substances within practices.

Under section 13.2 practices are required to show evidence of:

• an inventory of all the hazardous substances at your workplace, including substance type, quantity and location and associated data safety sheets
• hazardous substances in your workplace are added to the hazards and risk register
• team members working with hazardous substances are trained to work safely with them
• team members managing highly hazardous substances (such as class 6.1A and 6.1B substances) have certified handling certificates or work directly under the supervision of a certified handler.

Consideration should also be given to eliminating the risk where it is reasonably practicable to do so. 

Where it is not reasonably practicable, then a plan on how to minimise the risk could include:

• substituting the substance for a less hazardous substance
• removing the mist, gas or vapour at the source of generation using local exhaust ventilation
• isolating the process that uses the substance in an enclosure
• using the substance only in well-ventilated areas
• prevention of harm through personal protective equipment (PPE).

Procedures in your Emergency Management Plan and/or your Health Emergency Policy are reviewed and updated on a regular basis with consideration being given to relevant legislation and practice standards.

To meet this indicator (9.3), practices need:

• a documented medicine reconciliation policy and procedure in accordance with the Health Quality and Safety Commission Medical Reconciliation Standard 2012
• included in this policy is the requirement of an annual audit against the policy. 

Medicines reconciliation is about obtaining the most accurate list possible of patient medicines, allergies and adverse drug reactions by using two different sources of information. Sources of information could include a discharge summary, community pharmacy records, the patient or whānau, your practice management system. Reconciling medications reduces the risk of medication errors and confusion that may occur during patient transfer of care.  The RNZCGP have some good guidance around this based on the Health Quality and Safety Commission Medicine Reconciliation Standard. Most practices find that by starting with patients who have been discharged from hospital, it makes this a tangible group of patients to start the process with. Also we know that the interface between primary and secondary care is the area where most errors can occur so this is a good group of patients to use this process. 

Medicines reconciliation policy

The RNZCGP have a general policy that practices can use as a template.

Ensure you cover:

• accountability and responsibilities
• timelines for reconciling medicines within seven working days
• education and training of new practitioners and locums on how medicines reconciliation occurs in the practice – collect, compare, communicate
• method for how and when auditing is done
• frequency of auditing
• measuring and evaluation
• reporting
• how the practice addresses areas for quality improvement.

Medicines reconciliation audit

Every practice needs to audit regularly against their process in the policy (at least annually). The college have a good template that you can use on their site (medicines reconciliation process and audit MARCH 2025). This template on its own is not enough to meet the standard.  Ensure you include in the narrative the way you audited your patients. Acknowledgement to Lakes Surgery for their example below. 

Methodology

• Reports were run in the practice’s PMS to identify inbox records for specialist letters and hospital discharge summaries.
  • Timeframe was records dated between the 1^stand 14^th of August 2022.
  • 42 discharge summaries were detected and 5 of these were selected at random (every 8^threcord).
  • 237 other scanned inbox records were detected and 10 of these were selected at random (every 23^rdrecord). If the random record was not a specialist letter the next record on the list was selected instead.
• A total of 15 records were looked at (5 discharge summaries and 10 specialist records) to check whether medicine reconciliations had been done.
• They were also checked to see if the reconciliation was completed within 1 week of being received.

Results

• All records that had medications had a reconciliation done.
• All reconciliations were completed within the one-week time frame.

Discussion

• Discussion was held on Monday 29 August at the morning team huddle, 9am.
• Discussed who we can send medicine reconciliations to now that our clinical pharmacist has left. Agreed to send to Louise, nurse prescriber, who is able to do these reconciliations.
• Previous clinical pharmacist was provided by Pinnacle one day per week. Manager to check with Pinnacle around replacement clinical pharmacy

To meet this indicator (9.1), practices need:

• a documented repeat prescribing policy and procedure
• annual audits of repeat prescribing activity in accordance with the policy. 

Repeat prescribing policy

All practices are required to have a repeat prescribing policy.

The documented policy for repeat prescribing needs to outline a reliable, safe and consistent approach to repeat prescribing. 

Considerations

• Roles and responsibilities within the practice. Note only authorised prescribers can prescribe – in practices this is normally general practitioner, nurse practitioner, pharmacist prescriber or delegated prescriber.   
• Regular assessment guidelines to ensure the prescription remains appropriate.
• A definition of what constitutes appropriate regular review - and is it different for different conditions.
• Any medical conditions or medications that cannot be prescribed without a consultation.
• Additional measures to optimise Māori access to repeat prescriptions and collection of medicines. 
• An e-prescribing process (if applicable).
• How the policy is always accessible to the clinical team.
• Annual auditing process which includes audits that differentiate Māori from non-Māori.
• How audits will be discussed and actioned at clinical governance meetings. 

Annual audit

The purpose of auditing is to ensure that the repeat prescribing policy and procedure is being adhered to. By auditing the policy and then differentiating Māori from non-Māori, the practice can identify whether there are any inequities existing which might prompt an improvement initiative.

The audit needs to reflect checks that show alignment with your policy. A good way to do this is to print out your policy and mark points you want to monitor. Depending on what is in your policy you could audit:

• how the request came into the practice (e.g. if your policy says it cannot come via email, ensuring this occurred)
• role of staff member who generated the repeat
• whether there is an indication for each medication
• time prescription is sent to pharmacy (if your policy stipulates a time period)
• is the patient being monitored for potential adverse effects.

Include in your evidence:

• your findings and reflections
• actions
• next review date
• date the audit is discussed at Clinical Governance meetings and any recommendations.

The college have a good template that you can adapt on their website (Sample template for repeat prescribing audit).