QCPP has a set of rules covering all aspects of the program and the rights and obligations of accredited pharmacies, marketing groups, sponsors and assessors
Rule 1: Period of accreditation
Accreditation is for two years effective from the initial assessment date, and dependent upon the pharmacy maintaining financial QCPP status.
Rule 2: Effective date of accreditation
Accreditation starts from the date of initial assessment, irrespective of any remedial action or sanction. Accreditation ends the day before the second anniversary of the assessment day.
Rule 3: Period in which an assessment must be undertaken
An assessment must be undertaken within three months either side of the effective date of accreditation as defined in Rule 2. To have the assessment after the accreditation date, the pharmacy must apply for an extension of accreditation to QCPP, prior to the accreditation date outlining grounds for special consideration.
Rule 4: Status of accreditation when remedial action is required after an assessment
If remedial action is identified during an assessment, the pharmacy has three months from the date of the assessment to undertake the identified remedial action and have the remedial action verified as being complete by the assessor. During this period, the pharmacy is deemed to have QCPP accreditation. If remedial actions are not completed and verified in the three month period, the pharmacy has not met the requirements of accreditation and becomes unaccredited. The pharmacy is liable for any costs associated with the verification of remedial action.
Rule 5: Accreditation on the change of ownership, relocation of a pharmacy or change of details
Accreditation is issued to a pharmacy business entity. Within three months of a change of ownership, relocation or change of other details, the owners are to complete the ‘Accreditation – Change of Pharmacy Status’ form (available from the QCPP website) and forward it to QCPP.
Rule 6: Allocation of an assessor
The pharmacy will be allocated an endorsed QCPP assessor. The pharmacy may request a change of assessor if there is a real or perceived conflict of interest. The new assessor will be allocated through the QCPP allocation process.
Rule 7: Requirements for additional information
An assessor cannot request access to additional information not defined in the QCPP Requirements, unless that additional information is authorised by the QCPP.
Rule 8: Senior Assessor/QCPP Authorised Attendee
During an assessment, a Senior Assessor (or other QCPP Authorised Attendee) may accompany the assessor. The purpose of this attendance is so the Senior Assessor can validate the assessment approach used by the assessor. Other QCPP authorised attendees present will normally act as observers. All costs associated with the Senior Assessor (and other QCPP authorised attendees) will be borne by QCPP. The pharmacy agrees to cooperate with the Senior Assessor or any QCPP Authorised Attendee.
Rule 9: Prerequisites to accreditation (acceptance of program and assessment rules)
Accreditation can only be issued if the Program and Assessment Rules are accepted by the pharmacy. Acceptance will be proven by signing the acknowledgement contained on the QCPP registration form, the cover of the remedial action report and the annual declaration.
Rule 10: Completion of all outstanding actions and sanctions
All remedial actions requiring sign-off for accreditation and sanctions (including directives issued by a state and/or national registering authority) must be completed before accreditation is formally issued.
Rule 11: Modifications to procedures and templates
The procedures and templates included in the QCPP material are advisory. While these procedures and templates can be modified, they must at least contain all mandatory information provided.
Rule 12: Relevant reports
An assessor may be given access to other assessment reports (e.g. Mystery Shopper assessment). The assessor may be required to validate areas of improvements identified in such reports prior to starting the assessment.
Rule 13: Access to evidence
Each element of the Standard defines the evidence required to be provided at the time of the assessment. The assessor must be able to sight the listed evidence on the day of the assessment.
Rule 14: Access to certain records
For some actions, assessors will be required to obtain evidence which confirms the presence of business or personal information. Assessors are required to satisfy themselves that any record tendered as evidence is what it purports to be. However, they do not need to undertake a detailed investigation of the data contained. The pharmacy may choose to mask commercial or personal information if it is not relevant to the purpose of checking the record.
Rule 15: Mandatory documents program resources
Program materials (excluding the CD) are mandatory under QCPP requirements and must be present at each assessment. If the mandatory documents are not present at the assessment, a sanction may be imposed.
Rule 16: Assessment methodology
The assessment will be conducted using a conformance/non-conformance methodology If the action is deemed to be not applicable to pharmacy operations, it will not be assessed.
Rule 17: Mandatory actions
Actions are either mandatory or optional. All mandatory actions are identified in each element and template checklists that relate to Elements 2 and 3. A pharmacy must be fully compliant in all mandatory actions assessed to receive accreditation.
Rule 18: Actions deemed not applicable
A limited number of actions may be deemed as not applicable. If an action does not apply to the pharmacy it will not be assessed or scored.
Rule 19: Pass mark for accreditation
To become accredited, a pharmacy must be fully compliant with all mandatory actions assessed. Note: These rules are subject to change, and the latest edition is available at www.qcpp.com/accreditation/rules QCPP Version 2.2 © 2016 Pharmacy Guild of Australia 45
Rule 20: Complaints about an assessor or assessment
Should a pharmacy have concerns about an assessor and/or the assessment process as applied during a specific assessment, a formal complaint detailing the nature of the complaint and resolution sought should be lodged in writing, using the complaint form available on the QCPP website to: QCPP Complaints Officer The Pharmacy Guild of Australia PO Box 310 Fyshwick ACT 2609 All complaints will be investigated by an appropriate independent party and a written response provided. The pharmacy must support the investigation.
Rule 21: Complaints lodged about an accredited pharmacy
Any complaint lodged about an accredited pharmacy will be investigated, providing the details of the complainant are disclosed. All complaints relating to a pharmacy meeting accreditation requirements will be investigated by an appropriate independent party and a written response provided. The pharmacy must support the investigation. The details of a complaint or investigation may be referred to appropriate authorities.
Rule 22: Sanctions against pharmacies
The following sanctions can be applied to an accredited pharmacy: * A warning. The issue(s) will be re-examined at the next assessment. * Partial re-assessment within a period of time not to exceed six months. * Assessment without notice. * Suspension of accreditation for a period of up to six months, after which a re-assessment is required (either partial or full). The pharmacy is liable for all costs associated with an assessment as a result of a sanction. The period of accreditation does not re-start as a result of an assessment due to a sanction.
Rule 23: Appeals against an investigation finding or sanction imposed
A pharmacy may lodge an appeal against the findings of an investigation or a sanction that is applied. The appeal is to be made in writing to: QCPP Complaints Appeal Committee Pharmacy Guild of Australia PO Box 310 Fyshwick ACT 2609 All appeals will be investigated by an independent review committee external to QCPP and a written response provided. The review committee’s decision is final. Details of the review committee are on the QCPP website.
Rule 24: Participation in other assessments
The pharmacy will participate in other assessments of service (e.g. SMA visit, assessment without notice or random assessments) endorsed by QCPP and limited to a maximum of six assessments per year. The pharmacy agrees to use its best endeavours to obtain all necessary consents associated with other assessments (refer to information on the QCPP website). Any assessment associated with a sanction is not to be counted in this limit of six ‘other assessments’.
Rule 25: Assessments with or without notice
The pharmacy may be subjected to an assessment with or without notice. These assessments will be conducted and scored in accordance with the rules defined on the QCPP website.
Rule 26: Use of the QCPP logo, signage and certificates
The pharmacy will comply with the requirements associated with the use of the QCPP logo, signage and certificates as detailed on the QCPP website. The QCPP logo, signage and certificates can only be displayed while the pharmacy is accredited.
Rule 27: Marketing groups and the QCPP logo
A marketing group can only use the QCPP logo if 100 percent of pharmacies within the group have accreditation. New pharmacies joining the marketing group have a period of 12 months to become accredited without affecting the use of the logo by the marketing group.
Rule 28: Internet pharmacy and the QCPP logo
When an internet pharmacy uses the QCPP logo, the website must clearly identify those pharmacies which have current accreditation by inserting the QCPP logo adjacent to the name of each accredited pharmacy.
Rule 29: Incentives, fees and subsidies for accreditation
Accreditation can only be issued and maintained throughout the accreditation period if all program fees have been paid by the pharmacy. Details of incentives, fees, subsidies and associated rules are contained on the QCPP website.
Rule 30: Internet pharmacy
‘Mystery Shopper’ techniques may be used over the internet as part of the assessment of an internet pharmacy. An internet pharmacy must not promote or offer for sale tobacco, tobacco/smoking related products or implements, alcoholic beverages, home brewing or alcohol distilling kits on their website.
Rule 31: Additional services commenced between assessments
Accreditation is issued to a pharmacy business entity. Within three months of a new service (as defined in Elements 2 and 3), hiring equipment, distance dispensing or internet pharmacy being commenced, the owners are to complete the ‘Accreditation – Change of Pharmacy Services’ form (available from the QCPP website) and the Director of the QCPP Division. The information provided on the form will be used to determine if and when additional assessments will be undertaken. Failure to lodge the declaration within three months may result in sanctions being applied.
Rule 32: Advertising of services
A pharmacy is not to advertise an approved health program or service listed in Elements 2 and 3 until such time as they comply with the requirements of the QCPP and have been assessed as compliant.
Rule 33: Validity period of QCPP certificates
QCPP certificates of accreditation are valid for 2 years. The issue of updated certificates will occur after accreditation has been granted by the QCPP.
Rule 34: Use of statistical data
The pharmacy agrees to allow data captured on the T1A Legal and Professional Obligations Declaration to be used for analysis and/or advocacy purposes unless otherwise stated in the declaration at the time of lodgement. All individual identifying information will be removed from the data prior to use.
Rule 35: Separate trading area
If a pharmacy declares stock or services are being traded by a separate business that is adjoining the pharmacy, for the purposes of QCPP, the pharmacy must ensure:
- The separate business provides independent access from a common public area.
- There is a floor to ceiling wall for at least 50 percent of the common boundary between the pharmacy and the adjoining business.
- The remainder of the common boundary is capable of being closed and locked so no access from one business to the other is possible.
- The pharmacy and any adjoining entity operate separate point of sale systems.
- Pharmacy staff are identifiable as being unrelated to any adjoining entity.
- Stock from any adjoining entity cannot be purchased in any other adjoining entity. Where all of the above requirements are not met, the pharmacy and all adjoining entities that do not comply with the above requirements will be considered as part of the pharmacy premises, and subject to assessment under QCPP.
QCPP Version 2.2 © 2016. This work is copyright to The Pharmacy Guild of Australia. No part of these materials may be produced in any form without written permission of The Pharmacy Guild of Australia. Requests and enquiries concerning the reproduction and rights should be directed to the Director Quality Care Pharmacy Program, The Pharmacy Guild of Australia.