Regulatory Compliance

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Follow - up required?

  Yes

  No

  N/A

Current Reference Works on Hand (either hard copy or electronic copy)

• APF ( Some States also have compulsory equipment requirements in terms of scales, measures, glass slabs etc)<br>

  Yes

  No

  N/A

• AMH

  Yes

  No

  N/A

• Therapeutic Guidelines (Complete set), ETG or equivalent

  Yes

  No

  N/A

• Source of Current Australian Product Information and Consumer Medicine Information<br>(MIMS Annual with MIMS Abbreviated, e-MIMS or AusDI Advanced)

  Yes

  No

  N/A

• Drug Interactions reference (updated at least quarterly) (AusID Advanced, Drug Interaction Facts, Drug Interaction Analysis and Management, eMIMS Drug Alert Interactions, Micromedex, Stockleys Drug Interactions Online or Lexi-Interact Online)

  Yes

  No

  N/A

• Pediatric Reference (from an Australian source including a teaching hospital)

  Yes

  No

  N/A

• Evidence-based reference work on complimentary and alternative medicines<br>(Herbs and Natural Supplements, Herbal Medicines, eMIMS or AusID Advanced)

  Yes

  No

  N/A

• Electronic Access to current publications (as required by the Pharmacy Board of Australia) <br>(Office Consolidation or copies of the legislation controlling the practice of pharmacy)

  Yes

  No

  N/A

Quality Program

• Is the pharmacy certified under the Pharmacy Guild of Australia's Quality Care Program

  Yes

  No

  N/A

• Date of program completion

  Date

• Date of expiry

  Date

Standard of Premesis

• Dispensary not less than 9m squared

  Yes

  No

  N/A

• Hygienic Condition

  Yes

  No

  N/A

• Adequate Ventilation

  Yes

  No

  N/A

• Adequate Lighting (what is the standard for this type of work)

  Yes

  No

  N/A

• Temperature Control of Therapeutic goods and health care products (room temp <25 degrees and refrigeration

  Yes

  No

  N/A

• Safe, secure and hygienic storage of therapeutic goods and health care products

  Yes

  No

  N/A

• Safe and secure storage of confidential and sensitive information. Appropriate disposal of confidential information

  Yes

  No

  N/A

• Supervision from dispensary for all scheduled medicines

  Yes

  No

  N/A

• Premises registration certificate

  Yes

  No

  N/A

• Adequate shelving for Schedule 4 poisons<br>(Has a balance check of S8's been performed in the last 4 weeks? Random audit should be performed of record keeping and balances of fast moving items. Is the process used to deal with incorrect stock balances in the S8 register appropriate and in line with regulations?)

  Yes

  No

  N/A

• Barcode scanner

  Yes

  No

  N/A

• Adequate counselling area showing consideration for patient privacy

  Yes

  No

  N/A

• Non-PBS Approved pharmacies only – adequate signage explaining consequences of not obtaining medicine as a pharmaceutical benefit

  Yes

  No

  N/A

• DAA packing – adequate space, adequate storage of patient medication; process - final check must always be checked by a pharmacist and a procedure in place for medication changes and there should be records kept of date of filling, initals of person filling, initials of the person checking and initals of the person handing out the pack

  Yes

  No

  N/A

• Record keeping for compounded and re-packaged items - is it appropriate?<br>(Use of and filing of appropriate Batch sheets or compounding recording book.

  Yes

  No

  N/A

Prescription Dispensed

• Prescriptions Monday AM

• Number of Pharmacists Monday AM

• Prescriptions Monday PM

• Number of Pharmacists Monday PM

• Prescriptions Tuesday AM

• Number of Pharmacists Tuesday AM

• Prescriptions Tuesday PM

• Number of Pharmacists Tuesday PM

• Prescriptions Wednesday AM

• Number of Pharmacists Wednesday AM

• Prescriptions Wednesday PM

• Number of Pharmacists Wednesday PM

• Prescriptions Thursday AM

• Number of Pharmacists Thursday AM

• Prescriptions Thursday PM

• Number of Pharmacists Thursday PM

• Prescriptions Friday AM

• Number of Pharmacists Friday AM

• Prescriptions Friday PM

• Number of Pharmacists Friday PM

Pharmacy Access

• Can the pharmacy be accessed directly from within the premises of a supermarket?

  Yes

  No

  N/A

Matters for further discussion

• CPI

• Follow - up required?

  Yes

  No

  N/A

• Primary health care (eg.smoking cessation, community lectures, participation in medicines week, etc.)

• Follow - up required?

  Yes

  No

  N/A

• DDA - register and entering out and storage - minimum specifications dependon the number of doses stored. Sending in of DDA scripts by 7th day of the month

• Follow - up required?

  Yes

  No

  N/A

• Workloads

• Follow - up required?

  Yes

  No

  N/A

• Medicine/buprenorphine substitution program

• Follow - up required?

  Yes

  No

  N/A

• CAL’s

• Follow - up required?

  Yes

  No

  N/A

• Sale and supply of psuedoephidrine - project stop

• Follow - up required?

  Yes

  No

  N/A

• Storage of schedule 3 medication

• Follow - up required?

  Yes

  No

  N/A

• Dispensing scripts from faxed copies. Scanned copies. Duplicates, phone orders - what is the site policy and does a script follow within 24 hours

• Follow - up required?

  Yes

  No

  N/A

• Practising certificates for each pharmacist working at the site

• Follow - up required?

  Yes

  No

  N/A

• Display of pharmacy owners names and PIC/Pharmacist on duty

• Follow - up required?

  Yes

  No

  N/A

• Alarm system and is it monitored

• Follow - up required?

  Yes

  No

  N/A

• Cold Chain testing

• Follow - up required?

  Yes

  No

  N/A

• All staff knows where to access and have read the HPS Pharmacies Operations Manual.

• Follow - up required?

  Yes

  No

  N/A

• You have a current copy of the Professional Practices Standards and all pharmacists have reviewed the standards & completed the check sheet. This document can be found in the accreditation folder located on the Q drive or on the intranet

• Follow - up required?

  Yes

  No

  N/A

• All equipment has been calibrated

• Follow - up required?

  Yes

  No

  N/A

• Your evidence folder is up to date and includes all templates, checklists and documentation that the auditor will require. (Please refer to evidence checklist). This is available in your site’s QCPP accreditation folder.

• Follow - up required?

  Yes

  No

  N/A

• Every phone has a Bomb Threat checklist next to it. This document can be located in the accreditation folder on the Q drive or on the intranet.

• Follow - up required?

  Yes

  No

  N/A

• Your site has a current copy of the Customer Service Statement displayed. This document is available in the operations manual but may need to be adjusted for your site.

• Follow - up required?

  Yes

  No

  N/A

• If you counsel patients you have the What Stop Go poster displayed in your professional services area and your professional services area is clearly separated from your front dispensary area. A copy of the What Stop Go poster can be obtained in the accreditation folder in the Q drive or on the intranet.

• Follow - up required?

  Yes

  No

  N/A

• You have the safe lifting/manual handling poster displayed in the pharmacy for all staff members who may be required to lift or transport heavy objects. This document is available in the accreditation folder located on the Q drive or on the intranet.

• Follow - up required?

  Yes

  No

  N/A

• All dispensary stock has been checked for expiry dates, and all expired stock removed. Any short dated stock is clearly marked and located at the front of the shelves to ensure that purchasing staff monitor the expiry date.

• Follow - up required?

  Yes

  No

  N/A

• All staff members are in full HPS uniform and have personal identification tags. If new identification tags or uniforms are required, you will need to liaise with HR.

• Follow - up required?

  Yes

  No

  N/A

• All Cytotoxic medication has a PURPLE cyto sticker on the barcode

• Follow - up required?

  Yes

  No

  N/A

• All fridges have been checked and no food or drink is stored in any vaccines fridges

• Follow - up required?

  Yes

  No

  N/A

• The pharmacy is clean, neat and tidy and complies with all OHS standards and regulations. Your regulations are located in your QCPP manual.

• Follow - up required?

  Yes

  No

  N/A

• When was the last site meeting + view agenda

• Follow - up required?

  Yes

  No

  N/A

• Return of unwanted medication procedure

• Follow - up required?

  Yes

  No

  N/A

• Practice professional indemnity insurance

• Follow - up required?

  Yes

  No

  N/A

• Lease for premises

• Follow - up required?

  Yes

  No

  N/A

Contract Service Level

• Hours of clinical service in line with contract

  Yes

  No

  N/A

• FTE allocation in line with contract

  Yes

  No

  N/A

• Service fees as per contract - are all aspects of service being charged

  Yes

  No

  N/A

• Mark up as per contract

  Yes

  No

  N/A

• Are reporting deadlines being met

  Yes

  No

  N/A

• Key KPIs being met

  Yes

  No

  N/A

• Have all variations to contract been documented

  Yes

  No

  N/A

Customer service/communications.

• When was the manager's last meeting with Hospital management - GM and DON. What is their process for handling Incidents/corrective actions?

  Date

• What is their process for handling Incidents/corrective actions?

Operational Processes

• My Patient process is being followed

  Yes

  No

  N/A

• Is the script owing process best practice?

  Yes

  No

  N/A

• Are PPIs provided?

  Yes

  No

  N/A

• Has the PPI target been achieved?

  Yes

  No

  N/A

• Are medscheck being provided?

  Yes

  No

  N/A

• Is the Medscheck target being achieved?

  Yes

  No

  N/A

• Is the PBS claim closed on the last day of the month?

  Yes

  No

  N/A

• Other observed processes