Australian Capital Territory
Health (Nurse Practitioner Position and Scope of Practice) Approval 2015 (No 1)*
Notifiable instrument NI2015-164
made under the
Health Regulation 2004 - section 8 (Approval of nurse practitioner positions) 

1	Name of instrument

This instrument is the Health (Nurse Practitioner Position and Scope of Practice) Approval 2015 (No 1).

2	Commencement

This instrument commences on the day after notification.

3	Scope of Practice for nurse practitioner positions

Under section 8, approval of nurse practitioner positions, I have approved the establishment of Medimobile nurse practitioner positions within an approved network of pharmacies in the ACT, for the specific purpose of administering influenza preventative vaccines and any health care deemed appropriate by the nurse practitioner in the event of an emergency such as anaphylaxis to the vaccine.  The scope of practice statement for this Nurse Practitioner position is attached within the attached business case. 

The Clinical Practice Guidelines for these positions have been approved and endorsed by the ACT Chief Nurse and Director-General ACT Health prior to being posted on the ACT Health Nursing & Midwifery website. 

Dr Peggy Brown
Director-General

14 April 2015

Attachment A

13 January 2015 Susan Marbrow Nurse Advisor
Nursing & Midwifery Office ACT Health
Level 3, Building 6| Canberra Hospital| PO Box 11|WODEN ACT 2606 Phone: 6244 2352 | Email: susan.marbrow@act.gov.au
Contact details:
Dr Kirsten Baulch MBS FRACGP  kirsten@medimobile.com.au
Ph 0433 141 166
NURSE PRACTITIONER
CLINICAL PRACTICE GUIDELINE INCORPORATING STANDARD OPERATING PROCEDURES, SCOPE OF PRACTICE AND BUSINESS CASE FOR:
VACCINE ADMINISTRATION IN AUSTRALIAN CAPITAL TERRITORY PHARMACIES
Reference:
•	Vaccine Management Policy, General Practice Support, Medicare Local 2012
•	The Australian Immunisation Handbook (10th edition)
•	Department of Health and Ageing, ‘National Vaccine Storage Guidelines 2nd Edition: Strive for 5’
•	Immunise Australia Program
•	Immunise Australia Information Line:1800 671 811
•	Department of Health Immunisation Program: 1300 882 008
•	MBS Online Search item numbers
•	Australian Childhood Immunisation Register (ACIR)
•	National Health & Medical Research Council (NHMRC)
•	The Australian Health Practitioner Regulation Agency (AHPRA)
•	ACT Draft Guidelines for Scope Of Practice for Nurse Practitioners 2013 (ACT Health)

SCOPE
The establishment and approval of Nurse Practitioner (NP} positions in the private health sector is governed by legislative requirements. This Clinical Practice Guideline with incorporated Scope of Practice aligns with both ACT and Commonwealth legislation and the Australian Health Practitioner Regulation Agency and outlines the process for Medimobile

Flu Services to:
•	Establish and implement Nurse Practitioner (NP) positions within the approved network of pharmacies for the purpose of administering influenza preventative vaccines +/- healthcare as deemed appropriate by the nurse practitioner in the event of an emergency, such as anaphylaxis to the injectable.
•	Comply with legislative requirements.

The key principles for the establishment of a nurse practitioner position within a private pharmacy are that:
•	NP positions are established to address gaps in service delivery to target populations by introducing new flexible and innovative models of care or by complementing existing services
•	The establishment and implementation of NP services is guided by a consistent process within a supportive and collaborative environment with the pharmacist
•	NPs must possess and maintain relevant knowledge, skills and competencies to support the provision of quality and safe health care;
•	NPs are always responsible and accountable for their own actions
•	NPs must maintain appropriate registration with the Australian Health Practitioners Regulation Agency, and
•	NPs are supported by robust clinical governance frameworks.

CPG STATEMENT
The aim of this clinical practice guideline is to ensure vaccine effectiveness from delivery to the time of administration by nurse practitioners.
Maintenance of the Cold Chain system requires that processes are in place to ensure that a potent vaccine reaches recipients, as vaccines which have lost their potency as a result of improper handling will not protect recipients from the diseases for which they are designed. Potency cannot be restored once lost, even if the storage conditions are rectified.
RESPONSIBILITY
Medimobile Vaccine Logistics Team, the pharmacist and the individual nurse practitioner at each site of health delivery.
COLD CHAIN
•	The term ‘cold chain’ refers to the system of transporting and storing vaccines within the safe temperature range of +2°C to +8°C, from the time of manufacture until administration
•	Lack of adherence to the cold chain may result in loss of vaccine effectiveness, undue vaccine failure and an increased rate of local reactions after administration. (Refer to section below titled ‘Cold Chain Breach’)
•	All staff involved in the vaccination process form part of the cold chain and should be aux fait in vaccine storage and handling, including delivery procedures and temperature logging.

VACCINE REFRIGERATORS

•	Purpose-built vaccine refrigerators are the choice form of vaccine storage to be located on site at the pharmacies.

•	Cyclic defrost and bar refrigerators are not recommended for vaccine storage
•	Vaccines are at greater risk when stored in domestic refrigerators as they do not have consistent temperatures throughout, and it is recommended to have the      refrigerator ‘mapped’ annually to be aware of cold spots in each refrigerator. This can be carried out using data loggers (Refer to section below titled ‘Temperature Data Loggers’)
•	If domestic refrigerators must be used for vaccine storage, refer to the guidelines listed in the Department of Health and Ageing – ‘National Vaccine Storage Guidelines 2nd Edition; Strive for 5’ and the Medimobile Vaccine Management Protocol
•	Only vaccines to be stored in fridge. Patient’s own medicines should be stored in a separate refrigerator
•	Food and drinks must not be stored in vaccine refrigerators, and a sign indicating such should appear on the door
•	Ensure that the power source to the refrigerator is secured, preventing the switch from being accidently turned off – use a dedicated power point
•	Door openings should be kept to a minimum - only open the door as necessary to access vaccines
•	Place reminder sign on front of refrigerator door – ‘STOP – Do You Need to Open It?’
•	A shelf-plan or photograph placed on the outside of the solid refrigerator door indicating where vaccines are located may assist staff to locate vaccines quickly.

VACCINE DELIVERY AND STORAGE

•	All (currently available) vaccines require refrigeration and protection from ultra violet and fluorescent light
•	Check the delivery consignment immediately for temperature monitors to ensure there is no evidence of cold chain breach (Refer to section below titled ‘Cold Chain Breach’)
•	Check the supplier’s vaccine delivery record to ensure that the quantities of delivered vaccines are as ordered
•	Sign and date the vaccine delivery record and keep as documentation of transport company dispatch date, delivery date, vaccine type, batch numbers and expiry dates
•	Check expiry dates and rotate vaccines with nearer expiry date to the front of storage area
•	Store vaccines in original packaging as removal of packaging exposes vaccines to room temperature and/or lighting, and makes it difficult to easily detect expired vaccines.

TEMPERATURE RECORD LOG
•	The Vaccine Refrigerator Temperature Record is used for monitoring and recording of vaccine refrigerator temperatures. The temperature log forms part of the patient medical record and must be kept for a minimum of seven (7) years for medico-legal reasons
•	The NP is responsible for recording the minimum and maximum temperatures. Temperatures will be checked first thing each morning, before vaccines are used, and ideally again at the end of the day
•	The Temperature Log will be kept near the front of each vaccine refrigerator as a visual reminder, and a separate log maintained for each refrigerator used for vaccine storage
•	Vaccines must be kept at a temperature range between +2°C to +8°C, striving for
+5°C

•	Freezing is the most common cause of vaccine damage, and most refrigerated vaccines are rendered ineffective at temperatures below 0°C. See product information for specific vaccines
•	Diluents must also be protected from freezing, as freezing may cause tiny cracks within the wall of the diluent container.

TEMPERATURE DATA LOGGERS
•	Data loggers are small, electronic devices that measure vaccine refrigerator shelf temperatures and keep a record of the results over a period of time.
•	Each logger is a self-contained miniature computer.
•	Once programmed via a standard computer, loggers are disconnected from the computer and placed in the vaccine refrigerator.
•	The logger operates independently on its own battery until the recording is downloaded on to the computer.
•	Minimum/maximum thermometer readings must be maintained allowing the twice daily temperature recording to continue as a timely alert to any cold chain breach.
•	The data logger will record the date, time and temperature of the vaccine refrigerator shelves in increments. This allows the identification of temperature deviations, when, and for how long these occurred.

EXPIRED VACCINES
•	The expiry dates of all stored vaccines must be checked prior to use and documented. For Influenza vaccines, they must only be used in the year of their expiry and all expire at the same time.
•	Vaccines may be used up until midnight of their expiry date
•	Expired vaccines are to be removed from the refrigerator and discarded in an approved biohazard waste sharps container
•	Review vaccine ordering process to ensure minimal wastage in the future: Vaccine Expiry Date

VACCINE STORAGE SELF-AUDIT CHECKLIST
Performing a Vaccine Storage Self-Audit is important because:
•	It is part of routine quality assurance and risk management process
•	It enables you to have confidence that you are providing a safe and effective vaccine for administration
•	Self-Auditing is recommended at least every 12 months
•	See ‘National Vaccine Storage Guidelines 2nd Edition; Strive for 5’ page 42 for Vaccine Storage Self-Audit

COLD CHAIN BREACH
•	Cold Chain breach occurs when vaccine storage temperatures have been outside the recommended range of +2°C to +8°C (excludes excursions up to +12°C, lasting no longer than 15 minutes, when stock taking or restocking).
•	Even with optimal compliance with storage guidelines, occasional problems occur. A mechanical or electrical power failure may jeopardize the potency of a vaccine supply; the refrigerator may have been accidentally unplugged or the door may not have been closed properly.

•	The decision to continue to use a vaccine under these circumstances depends on advice obtained from the Medimobile Medical Director and the vaccine supplier.

Important! Where it can be determined that a cold chain breach has occurred:

•	DO NOT DISCARD vaccines but isolate affected vaccines immediately and label ‘Do Not Use’
•	Keep affected vaccines refrigerated until advice has been sought from the Medimobile Medical Director and the appropriate vaccine supplier:

Management of a Cold Chain Breach

In the event of a cold chain breach, immediately call Medimobile on 1300 660 339 or 0418 985 149 and record the following:

•	Date of the breach
•	Quantities of each type of vaccine
•	Vaccine service provider number
•	Time for which vaccines were outside acceptable temperature range (if known)
•	Maximum and minimum recorded temperature
•	Type of refrigerator used for vaccine storage
•	When the thermometer battery was last changed
•	Where the temperature probe is situated within the refrigerator
•	What do you think was the cause of the cold chain breach?
•	Has anybody been vaccinated with potentially affected vaccines?
•	Document the advice given and action taken (including person responsible)
•	Where the Medimobile has advised that the vaccines are to be discarded, remove from outer packaging and place them in an approved biohazard waste sharps container
•	Where Medimobile has advised that the vaccines are still fit for use, they can be returned to stock and the refrigerator door kept closed for the remainder of the day. The refrigerator should not be used for vaccine storage until it can maintain the appropriate temperature.
Handy Hint: Store a copy of the Cold Chain Breach Protocol on or near each vaccine refrigerator in the practice.
POWER FAILURE
•	If possible, identify the cause of the power failure (check power point) and rectify
•	Contact electrical supplier to determine length of power outage
•	Mechanical breakdowns should be repaired immediately
•	During a power failure of 4 hours or less, keep the refrigerator door closed. Place appropriate signage on door to deter others from opening the refrigerator until power is restored
•	For power failures more than 4 hours store vaccines in a cooler/vaccine esky with ‘conditioned’ ice/gel packs.
•	Continue to monitor the vaccine temperature by placing the thermometer probe inside a vaccine box inside the cooler. (Refer to section below titled Transportation of Vaccines)

Handy hint: Prior to any power failure contact electrical supply company to determine which electrical grid the practice is on. Also determine the closest pharmacy, Medimobile vaccine storage facility, or general practice on another grid which may not be affected by the same blackout, and who may agree to store practice’s vaccines as required.
TRANSPORTING VACCINES / VACCINE ESKY

•	While transporting vaccines or preparing a back-up refrigerator, vaccines may be stored in a small insulated container or esky, containing ice/gel packs.
•	An appropriate cooler is a solid-walled insulated container with a tight fitting lid.
•	The importance of ensuring that correct vaccine temperatures are maintained during transportation, or storage in vaccine esky, must not be underestimated.
•	Monitoring of vaccine temperature should continue by placing the thermometer probe inside a vaccine box inside the cooler
•	Vaccines should be left in their original packaging and must not come into contact with ice or gel packs, as freezing may occur
•	Place polystyrene chips, shredded paper or other insulating material at the bottom of the container
•	Surround the vaccines with packing material which allows cold air to circulate
•	Place the conditioned ice/gel packs on top, and ensure that vaccine stock is not in direct contact with the ice/gel packs as freezing may occur
•	Before ice/gel packs are used, they should be left at room temperature until water or ‘sweat’ appears on the surface. This ‘conditioning’ of the ice/gel pack minimizes the risk of damaging vaccines due to freezing.

ANAPHYLAXIS
•	Anaphylaxis is a severe adverse event of rapid onset, characterised by sudden respiratory compromise and/or circulatory collapse. Early signs include involvement of the skin, e.g. generalized erythema, urticaria, and/or angioedema (swelling), and/or gastrointestinal tract, e.g. diarrhoea, vomiting.
•	Anaphylaxis following routine vaccination is very rare, but can be fatal and all immunisation service providers must be able to distinguish between anaphylaxis, convulsions and fainting. Refer to Post vaccination procedures

VACCINE ADMINISTRATION
•	Check availability of medical personnel, protocols, emergency equipment and drugs necessary for the management of anaphylaxis, prior to any vaccine administration
•	Refer to NHMRC guidelines – The Australian Immunisation Handbook (10th edition) and the Medimobile Nurses Manual/Health Management Protocol for current vaccination schedule and standard vaccination procedures.
•	Explain to the patient (or, if a child, their parent/carer) the purpose of the vaccination, and any risks associated with immunisation. The patient (or, if a child, their parent/carer) should have the opportunity to ask questions
•	Consent to immunise should be documented in appropriate Medimobile® consent forms

Prior to administration, ensure the following:
•	Correct patient
•	Correct drug and dose (check expiry date)
•	Correct site
•	Correct route of administration
•	Any known allergies/contraindications?
•	Do not prime the vaccine with the needle cap completely off as there will be spray escape into the air and onto the immuniser.
•	Alcohol swabs are not used on the skin prior to vaccination
•	No need to draw back on syringe prior to administration
•	Leave small portion of need visible in case of sudden movement by the patient and the needle breaking – makes it easier to retrieve if there is a portion out of the skin
•	Administer vaccine safely
•	Dispose of needles, syringes and vaccine vial in accordance with standard infection guidelines
•	Document vaccination details in patient Medimobile Consent Record, including batch number. (Important in the event of product recall)
•	Keep vaccinated patients under observation in waiting area for at least 15 minutes after vaccination
•	Record all significant adverse events following immunisation

Resources

•	Australian Capital Territory Health Immunisation Program

The Medimobile Vaccine Logistics Team are available for extended hours on 1300 660 339 or 0418 985 149. The Medimobile CEO and Medical Director is also on-call via 1300 660
339 0418 985 149 for extended hours 7 days per week.
The ACT Health Immunisation Program provides information for service providers about ordering vaccine for the National Immunisation Program and other state vaccine programs. Telephone: (02) 6205 2300
•	Australian Childhood Immunisation Register (ACIR)

The Australian Childhood Immunisation Register records details of vaccinations given to children under the age of seven who live in Australia. It can provide you with information on your child’s vaccination history.
Telephone: 1800 653 809
•	Immunise Australia National Info line

The Immunise Australia National Info line provides information on immunisation. You can also phone the Info line to access Commonwealth produced immunisation resources.
Telephone: 1800 671 811
•	For advice on Communicable Disease Control / Public Health Reporting
Phone (02) 6205 2155

Fax (02) 6205 0711
Email cdc@act.gov.au
•	Immunisation
Phone (02) 6205 2300
Fax (02) 6205 0711
•	CDC Emergency pager (24hrs)
(02) 9962 4155

Address:
Howard Florey Centenary House 25 Mulley Street
Holder ACT 2611