Primary and Community Healthcare Standards

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Assessment to the National Safety and Quality Primary and Community Healthcare Standards

Accreditation provides assurances to the community that a healthcare service meets expected standards for safety and quality. It is a formal program in which trained independent reviewers assess a healthcare service’s evidence of implementation of the Primary and Community Healthcare Standards.

Accreditation commences

Healthcare services may now be assessed to the Primary and Community Healthcare Standards by an approved accrediting agency.

Accreditation to the Primary and Community Healthcare Standards is voluntary. In some circumstances, a healthcare service may be required to be accredited to the Standards to satisfy contractual, regulatory or licencing requirements.

Overview

Assessment to the Primary and Community Healthcare Standards involves a number of steps, conducted by an accrediting agency approved by the Commission. Once the healthcare service has entered into a contractual arrangement with the accrediting agency of choice, the assessment process will generally involve:

1. Application for not applicable actions	The healthcare service may apply to the nominated accrediting agency for relevant actions to be rated ‘not applicable’ at assessment.
2. Initial assessment	Using the selected model of assessment, the accrediting agency will: Review evidence provided by the healthcare service to demonstrate they have implemented the relevant actions in the Primary and Community Healthcare Standards and award a rating for each action. Advise the healthcare service of any actions rated ‘not met’ at the time of assessment Provide an initial report to the healthcare service within five business days of the conclusion of the initial assessment.
3. Remediation period	Where relevant actions assessed have been rated ‘not met’, the healthcare service will be given 60 business days to implement changes to demonstrate they have met the requirements of the specified actions.
4. Final assessment	The accrediting agency will conduct a final assessment within 65 business days of the Initial Assessment, using the selected model of assessment, to determine if actions rated ‘not met’ have been remediated, as well as whether any improvements have been made to actions rated ‘met with recommendations’.
5. Determination of accreditation	The accrediting agency will determine whether the healthcare service has satisfied the requirements of the assessment. The healthcare service will be awarded accreditation if all relevant actions in the Primary and Community Healthcare Standards are rated as ‘met’ or ‘met with recommendations’. The period of accreditation awarded will be dependent on the model of assessment used.

Detailed information about how assessments are conducted, rules and policies that apply are outlined in the following section.

How assessments are conducted, rules and policies that apply

Flow chart of assessment process

The flow chart in Attachment 1 of the Fact sheet: Accreditation to the National Safety and Quality Primary and Community Healthcare Standards provides an overview of the steps involved in the assessment and reporting process.

Front page of the fact sheet accreditation to the PCH Standards

Accreditation to the National Safety and Quality Primary and Community Healthcare Standards

2022

Fact sheet or brochure

Model of assessment

There are four models of assessment available for the Primary and Community Healthcare Standards. This flexible approach recognises the varying stages of readiness and engagement across the sector.

Model of assessment	Stage 1	Stage 2	Stage 3	Stage 4
Assessment method	Desktop assessment	Desktop + virtual assessment comprising observations and interviews	Desktop + on-site assessment comprising observations and interviews	Regulator-stipulated short-notice assessment comprising of desktop assessment + on-site visit
Accreditation cycle	Two years	Three years	Three years	Three years
Number of cycles at this assessment level	Two assessment cycles*	One assessment cycle for healthcare services involving physical examinations, therapies or procedures upon patients* Otherwise, unlimited	Unlimited	Unlimited
Public recognition	Certificate of Accreditation (Stage 1)	Certificate of Accreditation (Stage 2) Registered on the Commission's website	Certificate of Accreditation (Stage 3) Registered on the Commission's website	Certificate of Accreditation (Stage 4) Registered on the Commission's website
Certificate	Issued by accrediting agency	Issued by accrediting agency	Issued by accrediting agency	Issued by accrediting agency

^{* Approval for an extension to use a certain model of assessment for more than the specified limit of assessment cycles in any particular case may be granted by the Commission in exceptional circumstances based on criteria that includes a risk assessment, the nature of the healthcare service’s participation in the assessment process, its IT capacity, availability of other safety and quality data and evidence feedback on safety and quality performance against national or state-level agreed indicators.}

In most instances, a healthcare service may choose what model of assessment they undertake, dependent on their level of readiness. Healthcare services commencing accreditation via a desktop assessment model may do so for a maximum of two assessment cycles prior to progressing to a desktop assessment accompanied by a virtual assessment component model. In the case of healthcare services with facilities and equipment to support physical examinations of, or therapies or procedures upon patients, the use of this model should generally be limited to one assessment cycle. After this time, such a healthcare service will be required to progress to a desktop assessment with an on-site assessment component in order to enable in-person observation and inspection of equipment and facilities.

In exceptional circumstances, an accrediting agency may be granted approval to use an assessment model to accredit a particular healthcare service beyond the limit of assessment cycles applicable to that model. This approval to extend the use of a particular assessment model in a particular case will only be granted where the relevant healthcare service has requested the accrediting agency apply for such an exemption, and will be determined based on criteria relevant to the particular healthcare service under consideration, which includes the number of times any such extension has previously been provided, a risk assessment of the service, the nature of the service’s participation in the assessment process, its IT capacity, availability of other relevant safety and quality data and evidence feedback on safety and quality performance against national or state-level agreed indicators.

In circumstances where a healthcare service is required to be accredited to the Primary and Community Healthcare Standards to satisfy regulator, contractual or licensing requirements, the relevant regulator must stipulate the model of assessment to be used. In some instances, a regulator may also stipulate the model of assessment to be used is conducted at short notice.

Not applicable actions

Healthcare services implementing the Primary and Community Healthcare Standards should consider their individual circumstances in determining whether specific actions are not applicable. It is not intended that actions be implemented where they are beyond the scope of clinical practice of healthcare providers.

Large healthcare services, with multiple healthcare providers operating from different locations and delivering different levels of health care, may find that an action is not applicable in an area of service while remaining relevant in other parts of its service. In these cases, the action should be implemented in areas of the service where it is relevant, but not to the particular area of service where the action does not apply.

Where a healthcare service considers that an action is not applicable, evidence must be supplied to the accrediting agencies that is conducting the assessment to demonstrate that the action is associated with little or no risk of patient harm in their service context. Applications should be submitted to the approved accrediting agency well in advance of the assessment. Accrediting agencies are to provide an initial determination of the healthcare service organisation’s submission before undertaking the scheduled assessment. At assessment, assessors are to verify that the decision to award these actions not applicable status is justified.

Accrediting agencies are required to refer to the below when considering applications from healthcare service for non-applicability of actions within the Primary and Community Healthcare Standards. In large healthcare services, there may be specific areas of the service where an action does not apply, while remaining applicable elsewhere in the organisation.

Where there is a dispute concerning an award of not applicable status that is not resolved following discussions between the health service and the accrediting agency, application can be made by either the accrediting agency or healthcare service to the Commission for mediation.

Clinical Governance Standard

Patient safety and quality systems

Item	Action	Circumstances where actions are not applicable
Healthcare records	1.13	Not applicable when My Health Record system is not in use.
Healthcare records	1.14	Not applicable when My Health Record system is not in use.

Clinical Safety Standard

Preventing and controlling infection

Item	Action	Circumstances where actions are not applicable
Aseptic technique	3.07	Not applicable where aseptic technique is not required in the delivery of health care.
Invasive medical devices	3.08	Not applicable when invasive medical devices are not used in the delivery of health care.
Reprocessing of reusable medical devices	3.13	Not applicable when sterile reusable critical medical instruments, equipment and devices are not used in the delivery of health care.
Antimicrobial stewardship	3.14	Not applicable when prescribing, supplying and/or administering antimicrobial medicines does not form part of a service’s delivery of health care.

Medication safety

Item	Action	Circumstances where actions are not applicable
Documentation, provision and access to medicines-related information	3.15	Not applicable when prescribing, supplying and/or administering medicines does not form part of a service’s delivery of health care.
Safe and secure storage and supply of medicines	3.17	Not applicable when prescribing, supplying and/or administering medicines does not form part of a service’s delivery of health care.
High-risk medicines	3.18	Not applicable when prescribing, supplying and/or administering medicines does not form part of a service’s delivery of health care.

Comprehensive Care

Item	Action	Circumstances where actions are not applicable
Comprehensive care at the end of life	3.24	Not applicable when end-of-life care does not form part of a service’s delivery of health care.

Assessment methodology

Assessment methodologies adopted in the assessment of healthcare services to the Primary and Community Healthcare Standards are specified or approved by the Commission.

Desktop assessments

Accrediting agencies will use an assessment methodology that has been approved by the Commission when conducting desktop assessments.

The Commission may also issue guidance for conducting desktop assessments from time to time.

On-site and virtual assessments

PICMoRS is a mnemonic that was designed to help assessors to undertake assessment for accreditation under the AHSSQA Scheme. Originally developed for assessment to the National Safety and Quality Health Service Standards, it stands for:

Process;
Improvement;
Consumer participation;
Monitoring;
Reporting and Systems.

When undertaking or participating in virtual assessments, accrediting agencies and healthcare services must follow guidance issued by the Commission in relation to virtual assessments.

Hybrid assessments

Where the model of assessment to the Primary and Community Healthcare Standards involves an on-site assessment component, hybrid assessments may be utilised in limited circumstances.

A hybrid assessment is a model of assessment where part of an accreditation assessment team is on site at a healthcare service, and part of an assessment team participates using virtual access digital technology. Hybrid assessments may be conducted in exceptional circumstances where:

There is restricted access to all or part of a healthcare service due to public health orders or similar restrictions
The safety of patients and assessors is affected because the healthcare service is considered high risk
There are public health or border restrictions limiting movement of assessors across state and territory borders
An on-site assessment has commenced but cannot be completed due to changes in public health or border restrictions. Delay of an on-site assessment would not allow sufficient time for a healthcare service’s accreditation assessment to be completed prior to the current accreditation expiry date.

Hybrid assessment may also be considered for a healthcare service providing services over wide ranging, geographically remote locations. In some situations, hybrid assessments may assist to strengthen and make assessment processes more efficient. Accrediting agencies may apply to conduct hybrid assessments for these services where there is evidence of centralised, systematic clinical governance and management systems, policies and processes.

Prior approval from the Commission must be sought prior to on-site assessments being conducted via hybrid assessment. Accrediting agencies and healthcare services must follow guidance issued by the Commission in relation to virtual assessments.

PICMoRS Fact Sheet for Primary and Community Healthcare Standards

Using PICMoRS for quality improvement and assessment preparation

2023

Fact sheet or brochure

Fact Sheet on conducting virtual assessments for Primary and Community Healthcare Standards

Conducting virtual assessments to the National Safety and Quality Primary and Community Healthcare Standards

2023

Fact sheet or brochure

Rating scale for assessment

At the time a healthcare service is assessed against the Primary and Community Healthcare Standards, assessors will assess evidence of compliance to relevant actions in the Primary and Community Healthcare Standards and assign a rating. Ratings that may be attributed to individual actions are outlined below.

Rating	Description
Met	All requirements are fully met.
Met with recommendations	The requirements of an action are largely met across the primary healthcare service, with the exception of a minor part of the action in a specific service or location in the organisation, where the additional implementation is required. Met with recommendations may not be awarded at two consecutive assessments where the recommendation is made about the same service or location and the same action. In this case an action should be rated as not met.
Not met	Part or all of the requirements of the action have not been met.
Not applicable	The action is not relevant in the service context being assessed. The Commission’s direction relating to not applicable actions for the health sector need to be taken into consideration when awarding a not applicable rating and assessors must confirm the action is not relevant in the service context during the assessment visit.
Not assessed	Actions that are not part of the current assessment process and therefore not reviewed.

Sampling for accreditation assessment

Where multiple healthcare services operate under a single governance structure, a sample of healthcare services may be assessed to determine whether the healthcare service organisation as a whole meets the requirements to be awarded accreditation to the Primary and Community Healthcare Standards.

In these instances, accrediting agencies are to:

Use a risk‑based approach to obtain a sample for accreditation in line with the Commission’s sampling method
Seek approval from the Commission to use sampling before starting the accreditation assessment process

The following rules will apply when selecting the assessment sites:

The corporate or main healthcare service is always to be assessed
75 percent of sites assessed are to be selected based on a risk assessment by the accrediting agency. This assessment will take into consideration factors such as (but not limited to) previous assessment results, the last time the site was assessed, information provided in a gap analysis such as incidents and complaints, information in external reports, information gained in discussions with the healthcare service
25 percent of sites assessed are to be selected at random, ensuring a representative sample of the service is assessed
Accrediting agencies are to notify the healthcare service of sample sites just prior to or at the commencement of the assessment, and for rural or regional sites no more than six weeks in advance
Sample sites are to be selected by the accrediting agency, without taking into consideration the views of the healthcare service
Exceptions to point 4 and 5 of these rules can be made for healthcare service, where the availability of staff and patients is unpredictable and therefore requires some advance planning, or advanced notice is a requirement of entry to the service. Applications for exemption to point 4 and 5 will be considered on a case by case basis by the Commission. Where approval is granted, the approved accrediting agency can work in collaboration with the healthcare service in implementing rules 1-3 to maximise the number of staff, patients and sites that can be interviewed and visited during an assessment
Healthcare services seeking exemption from this sampling methodology are to make a submission in writing (which can be in the form of an email), to the Commission via their approved accrediting agency. The Commission will, in collaboration with regulators and/or funders where applicable, make a determination on these applications.

The following rules apply when assessing using sampling:

For the purposes of assessment reporting, the healthcare service as a whole will be assigned a rating for each assessable action of the Primary and Community Healthcare Standards.
All healthcare services included in the healthcare service organisation as a whole must be listed in the accreditation report and testimonial, and healthcare services assessed identified.

Award of accreditation

A healthcare service is accredited if all relevant actions in the Primary and Community Healthcare Standards are rated as ‘met’ or ‘met with recommendations’.

Accreditation is awarded for a period of either two or three years, depending on the assessment method used. The date of commencement of the accreditation period is the date the accrediting agency formally notifies the healthcare service of the final outcome of the accreditation assessment.

Accreditation Testimonial, Certificates and Reporting

Accrediting agencies are required to provide formal documentation to healthcare services as part of the accreditation assessment process. These include:

Accreditation report
Accreditation certificate (if a healthcare service is deemed to have met all requirements of the specified standard)
Testimonial.

The accrediting agency must include the following information in a testimonial that is to accompany the certificate of accreditation:

Healthcare service name
List of each facility and health service address covered by the award.
For each listed facility or service, whether the applicable accreditation relates to announced or short notice assessment
For each listed facility or service, the relevant standards to which the accreditation relates, and any parts of the relevant standards excluded from the assessment as not applicable or not assessed
Date of commencement and expiration of the relevant accreditation cycle.
Date accreditation is awarded.

Appeals process

If a healthcare service does not agree with their assessment outcome, an appeal may be submitted to their accrediting agency or directly to the Commission. It is strongly recommended that healthcare services exhaust all avenues of review or appeal with their accrediting agency before submitting an appeal to the Commission.

The Commission will only consider appeals where there is evidence that the relevant accrediting agency did not comply with Commission-specified policies, processes and/or directions relating to the assessment conducted.

An appeal, whether made to the accrediting agency or directly to the Commission, must be submitted within 20 business days of the healthcare service receiving its final assessment report from its accrediting agency. Where an appeal is made to the Commission following an appeal to its accrediting agency, it must be made within 20 business days of the accrediting agency ruling on its appeal.

All appeals are to be in writing and submitted to the Safety and Quality Advice Centre via AdviceCentre@safetyandquality.gov.au

Supporting evidence and documentation should accompany the appeal.

Submissions should include:

Name, title and contact details of the person (with delegated authority) submitting the appeal
Healthcare service name and address
Name of accrediting agency
Accreditation expiry date, if relevant
Assessment date(s) relevant to the appeal
Reason for submitting an appeal
Evidence supporting the appeal.

On receipt of an appeal, the Commission will seek information from the relevant accrediting agency, and review the evidence provided by the appellant, accrediting agency and regulator (if relevant). The Commission will then establish a panel to review the appeal and make recommendations to the Commission’s Chief Operating Officer.

The Commission may do one or more of the following:

Find any or all matters reviewed not substantiated
Find any or all matters reviewed substantiated and make recommendations to the agency for corrective action
Find any or all matters reviewed substantiated and take further action
Find any or all of the matters reviewed substantiated but determine further action is not warranted under the specified circumstances.

The Commission will:

Notify the relevant healthcare service and accrediting agency in writing of the outcome of the appeal, within five business days of the panel being convened.
Notify in writing the relevant healthcare service and accrediting agency of any action to be taken, together with the date of effect of that action.

Once the Commission has issued a determination, there is no further avenue of appeal within the Commission.

Mediation

Recognising exemplar practice

Exemplar practices are real-world examples of healthcare services that demonstrate best practice in the implementation of the Primary and Community Healthcare Standards. These services have safety and quality systems that are substantially higher than the general rating of ‘met’ for relevant standards or actions being assessed.

Approved accrediting agencies will be able to nominate healthcare services that have been awarded accreditation with all relevant actions rated as ‘met’ and are implementing an initiative that meets specified criteria. Initiatives considered as exemplars are:

Designed to address a significant safety and quality issue
Evidence-based or use best practice
Patient-centred
Clearly communicated to all relevant parties
Embedded into day-to-day practice
Regularly measured
Sustainable
Being appropriately evaluated
Improving patient outcomes in the safety and quality of care delivered.

Submissions will be reviewed by the industry-based accreditation coordinating committee against specified criteria. Healthcare services that are formally recognised as exemplars will be issued with a certificate and have their case study published on the Commission’s website. This is intended to facilitate the identification and sharing of information on safe and good quality practice.

Notification of significant risk

During the course of conducting an accreditation assessment, assessors may identify a significant risk. A significant risk is one where there is a high probability of a substantial and demonstrable adverse impact for a patient if it is not mitigated and is sufficiently serious to warrant an immediate response in order to reduce risks to patients. While the focus of reporting by assessors will be on significant risks of patient harm, it will not necessarily exclude other significant risks.

If one or more significant risks are identified during an accreditation assessment, assessors and/or approved accrediting agencies are to:

immediately notify the healthcare service of the risk(s) identified
discuss immediate action(s) to be taken by the healthcare service
develop a plan of action to resolve or mitigate the risk
notify the relevant authority and the Commission within 48 hours of identifying the risk
inform their clients and include relevant clauses in any contractual arrangements that information on significant patient risk will be provided to the regulators and the Commission when it is required by regulation or policy of a government agency.

Extension to accreditation award expiry date

Prior to the conclusion of a healthcare service’s accreditation cycle, the healthcare service will undergo a reaccreditation process, which involves a new assessment to assess compliance against the Primary and Community Healthcare Standards.

Assessment is usually conducted within the healthcare service’s current accreditation cycle, to enable sufficient time to complete the reaccreditation process prior to the expiry date of the current accreditation cycle. This method minimises any gaps in time between two consecutive accreditation cycles.

In limited circumstances, a healthcare service may wish to request an extension to their current accreditation award expiry date to provide additional time to complete the reaccreditation assessment process prior to the expiry of the current accreditation award.

The Commission grants requests for extensions to accreditation award expiry dates in exceptional circumstances. Requests can be made by:

a healthcare service
an approved accrediting agency on behalf of a healthcare service.

The Commission will seek advice from the accrediting agency in relation to the expiry dates, participation in accreditation processes and any other factors that may contribute to delays to the accreditation processes.

Once approved, accrediting agencies must formally notify healthcare services in writing of their updated accreditation award expiry date.

Transitioning between accrediting agencies

From time to time, a healthcare service may wish to change the accrediting agency they have engaged to conduct accreditation assessments. Healthcare services should not be prevented from transferring between accreditation service providers. In these instances:

The initial accrediting agency is the accrediting agency that currently provides accreditation services, and;
The receiving accrediting agency is the accrediting agency that the primary healthcare service wishes to engage as their future accreditation service provider.

Healthcare services wishing to change their accrediting agency during their current accreditation cycle are able to do so, provided that they:

Have signed a contract with the receiving accrediting agency prior to or immediately following cancellation of their client agreement with the initial accrediting agency
Maintain the existing accreditation cycle and schedule of assessment
Have no outstanding obligations to the initial accrediting agency.

Any current accreditation certificates awarded by the initial accrediting agency will continue to be recognised by the Commission until the expiry date of the current accreditation award.

The receiving accrediting agency must not issue replacement accreditation certificates for the current accreditation award.

Accrediting agencies are required to advise the Commission of healthcare services that change accrediting agencies during an assessment or before an accreditation award is determined.

Relocation of healthcare service

Where healthcare services are delivered from a fixed location, the environment where healthcare services are delivered may create additional safety and quality risks for patients. The degree of risk is dependent on the size and structure of the service and the complexity of the services it provides.

Healthcare services that have a fixed place of practice and are relocating to new premises during the accreditation cycle must notify their accrediting agency of their intention to relocate and take reasonable steps to ensure compliance with the Primary and Community Healthcare Standards are maintained and that increased risks of patient harm have been identified and are adequately mitigated at the new location.

Healthcare services that do not have a fixed place of practice will need to ensure there are strategies in place to comply with standards when delivering health care, in the setting where they are delivering care at the time.

Advisories

An Advisory is formal communication issued by the Commission to accrediting agencies and healthcare services. Advisories provide guidance and direction on the interpretation and/or assessment of the Primary and Community Healthcare Standards under the AHSSQA Scheme. Advisories will usually be issued when the Commission identifies that additional support is required to assist with the consistent implementation or assessment of a specific action or topic. An advisory may also be issued where the implementation of an action requires a stepwise process with long implementation timeframes.

Examples of topics where an advisory may be issued include:

managing conflicts of interest
informed financial consent
antimicrobial stewardship
viewing and providing clinical information to My Health Record
implementing Clinical Care Standards.

Advisory AS21/04: Provisional accreditation to the National Safety and Quality Health Service Standards for primary and community healthcare services

Contact us

For questions and feedback on the Primary and Community Healthcare Standards please contact the Safety and Quality Advice Centre via AdviceCentre@safetyandquality.gov.au or 1800 304 056.

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