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					(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control


DCGPA would like to acknowledge QIP/AGPAL for permission to reproduce parts
of this section from the QIP/AGPAL Policy and Procedure Manual 2006

4.1      Principles of infection control
Policy

Infection control procedures aim to prevent or minimise the spread of infection by
limiting the exposure of susceptible people to microorganisms that may cause
infection.

Because many infectious agents are present in health care settings, patients may
be infected while receiving care, health care workers (which include GPs and
nurses) may be infected during the course of their duties and other people (such
as receptionists) may be infected when working or interacting with patients.

Infectious agents evolve and constantly present new challenges in the health care
setting. Continually modifying and improving procedures is important in meeting
these challenges and to minimise the risk of litigation.

Our practice has a written policy on infection control processes within our practice
and this includes:

   Sharps injury management (Refer to section 3)
   Blood and body fluid spills management. (Section 4)
   Blood and body fluid exposure (refer to section 3)
   Hand hygiene
   A regular cleaning schedule describing the frequency of cleaning, products
    and procedures in clinical and non-clinical areas of our practice (Refer section
    5)
   The provision of sterile instruments whether by the use of disposables, or by
    onsite or offsite sterilisation of re-useable instruments
   Procedures for all aspects of the sterilisation process if instruments are
    sterilised onsite or for those instruments sterilised offsite, procedures covering
    both their sterilisation and transport there should be procedures for validating
    or obtaining evidence of validation for all on and offsite aspects of sterilisation
   Procedures for waste management including the safe storage and disposal of
    clinical waste (including sharps)
   The appropriate use of standard and additional precautions
   Prevention of disease in the workplace by serology and immunisation. (Refer
    to Section 3)
   Staff training (Refer Section 8)

 Hint
Helpful Resources:
                                                          Nov-99, Feb-2001, Dec-2001,
               Feb2003
                                                Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                         Sec.4 Infection Control

        QbAY >> Treatment Room,

        Department of Health and Ageing Infection control guidelines for the prevention of
         transmission of infectious diseases in the health care setting,

    
                                                                           th
          RACGP Infection Control Standards for Office Based Practices, 4 Edition

        RACGP 3rd Edition Standards 5.3.4


4.2        Blood and body fluid spills

Policy

Our practice has management systems for dealing with blood and body
substance spills.
    Blood and body fluids, include blood, vomit, urine, faeces, sputum and
      body tissue are treated a potentially infectious substances that can transmit
      disease should contact occur.
    Doctors, Nurses, other health professionals, practice staff and external
      contractors (eg. cleaners) consistently use standard precautions to achieve
      a basic level of infection control regardless of the known or perceived
      infection status of the patient.
    Any spillage needs to be treated promptly to reduce the potential for
      contact with other patients, staff or visitors.
    The employer is responsible to ensure all staff are familiar with the
      practice‟s policy and procedure for the management of blood and body
      fluid spills and staff receive adequate training on how to appropriately clean
      blood and body substance spills which is appropriate for the tasks they are
      expected to perform.

Our practice has a spills kit readily available consisting of a rigid walled container
with a lid containing:
   1 small bucket (with water level marked) and pre-measured amount of
detergent* (in a labelled container) to be made up when necessary
   Utility rubber gloves
   Face and eye protection: Goggles/safety glasses/face shield/mask
   Disposable or reusable impermeable/plastic apron/gown
   Roll of paper towelling (that retains strength when wet)
   Scrapers (2 pieces of firm cardboard or plastic)
   Hazard/cleaning sign
   Biohazard bag
   Polymerising beads or other absorbent material
   List of contents to assist restocking after use
       Copy of the instructions for cleaning spills


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(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

*The detergent used for general cleaning is satisfactory for treating most spills
(Source:Infection control standards for office based practices, 4th Edition)


Procedure
As part of the induction process all staff are provided with information about our
practice‟s protocol for managing spills of blood and body fluids.

In our practice, the Spills Kit is located (*Insert the location of the Spills Kit
here).

It is the responsibility of (*Insert staff member here eg the practice nurse) to
maintain the Spills Kit and to ensure all items are replaced after each use and the
items are not expired.


The management of spills should be flexible enough to cope with different types
of spills, taking into account the following factors:

   the nature of the spill, for example sputum, vomit, faeces, urine or blood
   the pathogens most likely to be involved in these different types of spills, for
    example stool samples may contain viruses or bacteria, whereas sputum may
    contain Mycobacterium tuberculosis
   the size of the spill, such as a spot, small or large spill
   the type of surface, for example carpet or vinyl flooring
   the area involved, such as whether the spill occurs in a contained area such
    as a consultation room or in a public area such as the waiting area.
   The possibility of some material remaining on a surface where cleaning is
    difficult (eg between tiles) and of bare skin contact with that surface ,

The affected area must be left clean and dry. Disposable items in the Spills Kit
must be replaced after each use and reusable items cleaned according to
protocol.

Method for cleaning spills
         Standard precautions apply. Use Personal Protective equipment.
            Tear off enough paper towel
            Prepare detergent and water
            Prepare rubbish bag
        If the spill is on a hard surface
                          -   Wipe up any solid matter and excess material



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                            -       Clean with detergent and water using a clean piece of
                                    paper towel each time.
                            -       Dry the surface


          If the spill is on a soft fabric or carpet
                            -       Use polymerising beads or other absorbent material
                            -       Scrape up residue
                            -       Dispose of contaminated material
                            -       Clean with detergent and water
                            -       Quarantine the area until dry
                            -       Consider arranging for the carpet to be cleaned with
                                    an industrial cleaner as soon as possible
                            -       an industrial carpet cleaner
               A disinfectant may be used after cleaning
 Hint
      Helpful Resources:

                                   QbAY >> Treatment Room,

         Department of Health and Ageing Infection control guidelines for the prevention of
          transmission of infectious diseases in the health care setting,

      
                                                                             th
          RACGP Infection Control Standards for Office Based Practices, 4 Edition

         DCGPA content of a spills kit resource available from the web www.dcgpa.com.au
      or at the end of this section in the Forms, Templates and checklists section


           rd
RACGP 3 Edition Standards Criterion 5.3.4



4.3       Hand washing and hand hygiene

Policy

Effective Hand hygiene has been proven to reduce the spread of infection. This
minimises the risk of cross-contamination through physical contact with patients
and co-workers, and touching inanimate objects which include door handles and
telephones.


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(Practice Name) Policy & Procedure Manual                     Sec.4 Infection Control

Gloves are not a substitute for hand cleaning. Fingernails are kept short and clean
and Jewellery to a minimum as these may harbour bacteria. Cuts and abrasions
are covered with water resistant dressings. Nailbrushes are not used.

The employer is responsible to ensure all staff have been educated on effective
hand hygiene and hand care.

Staff wash their hands

    Before and after examining and treating        After routine use of gloves
    patients
    Before and after and between performing        Before and after eating
    any procedure
    Before and after taking blood,                 Before and after smoking
    Before and after giving an injection           After blowing your nose
    After handling pathology specimens             After going to the toilet
    After handling any equipment that might        When visibly soiled or perceived
    have been soiled with blood or other body      to be soiled
    substance

Easy access to hand hygiene facilities is promoted with dedicated hand washing
facilities (with hot and cold water, liquid soap and single use paper towel) readily
available in every clinical management or treatment area.

Hand disinfectants designed for use without water, such as alcohol based hand
gel can be used in the following situations:

   emergency situations where there may be insufficient time and/or facilities eg
    in the Doctors Bags.
   when hand washing facilities are inadequate, eg reception areas, home visits
   in all treatment and examination areas to encourage hand hygiene in addition
    to hand washing facilities.
Visible soil must be removed with detergent based wipes first. If significant direct
physical contact with a patient or patient‟s blood or body fluids is likely to occur
this should ideally take place in an area where access to hand washing facilities is
available.


Hand Hygiene products need to be selected with consideration of the following
factors:
     Type of hand hygiene requires ie routine, aseptic (clinical), or surgical.
     The location of the product.
     Compatibility of agents if multiple agents are used eg hand creams, ointments.
     Care and protection of staff hands and sensitivities.
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(Practice Name) Policy & Procedure Manual                 Sec.4 Infection Control

There are no soap bars utilised in our practice. Where possible Liquid hand wash
dispensers with disposable cartridges, including a disposable dispensing nozzle,
are used. Where these are not available a pump pack is used. These are never
topped up and are ideally discarded when empty. Should they need to be refilled,
the container is washed and dried thoroughly prior. The nozzle is kept clean and
free of dried soap.

Appropriate facilities for drying hands are provided. Hot air dryers are not used in
clinical areas. Single use towels (paper or cloth) are provided in shared locations
and clinical areas. Disposable paper towel is used prior to aseptic procedures.

Hand moisturiser is made available for staff use.

Procedure

     Routine hand cleaning for soiled hands

     The following procedure is followed for a routine hand wash:
     1. wet hands thoroughly and lather vigorously using liquid soap
     2. wash for 10-15 seconds
     3. rinse thoroughly
     4. Dry with paper towel or single use cloth towel.
     5. use paper towel to turn taps off if not “hands free”


     Hand Washing for aseptic (non-surgical or clinical) procedures

     The following procedure is followed for a non-surgical hand wash:
     1. wash hands thoroughly using neutral liquid soap or an anti-microbial
     cleaner (eg 2% Chlorohexidine)
     2. wash for 1 minute
     3. rinse thoroughly
     4. dry thoroughly with paper towel or single use cloth towel
     5. use paper towel to turn taps off if not “hands free”.

     Hand washing prior to surgical (invasive) procedures
     The following procedure is followed for a surgical hand wash:
     1. Remove Jewellery
     2. Wet hands and forearms
     3. Wash hands, nails and forearms thoroughly with an antimicrobial
          cleaner (eg 4% chlorohexidine, 0.75% detergent based povidone, or
          1% aqueous povidine)
     4. first wash 5 minutes and each subsequent wash 3 minutes
     5. rinse carefully keeping hands above the elbows
     6. do not touch taps. (ask another staff member to do this if not “hands
          free”)
     7. dry thoroughly with sterile paper or cloth towels.
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(Practice Name) Policy & Procedure Manual                      Sec.4 Infection Control



*insert details specific to your practice
Location               hand washing           Equipped for     Equipped for    Equipped for
                       facilities             routine hand     aseptic hand    Surgical hand
                                              washing          washing         washing
Patient toilets        Liquid soap            yes              no              no
                       Air dryer
Consulting rooms Liquid Soap                  yes              yes             no
                 Antimicrobial
                 cleaner (2%
                       Chlorhexidine)

                       Paper towel
Treatment room         Liquid Soap            yes              yes             yes
                       Antimicrobial
                       cleaner (4%
                       Chlorhexidine)
                       Paper towel
                       Sterile towel



 Hint
Helpful Resources:

         QbAY >> Treatment Room,

         Department of Health and Ageing Infection control guidelines for the prevention of
          transmission of infectious diseases in the health care setting

          Handwashing wall chart available from the Prepared and Protected CD/DVD and
          resources http://www.health.gov.au.

      
                                                                          th
          RACGP Infection Control Standards for Office Based Practices, 4 Edition

           rd
RACGP 3 Edition Standards Criterion 5.3.4


4.4       Handling and use of chemicals
Policy




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(Practice Name) Policy & Procedure Manual                   Sec.4 Infection Control

Our practice does not use cleaning agents or other chemicals, which are known to
be toxic to the user, such as glutaraldehyde and chlorine based products.
Chemicals and cleaning agents used in our practice are used according to the
manufacturer‟s instructions.

Cleaning solution (detergents) that is mixed with other liquids by our practice is
made at the beginning of each working day and discarded at the end of each
working day with the container rinsed and left upside down to dry overnight. This
is to avoid the spread of microorganisms, which may have contaminated the
solution. To avoid wastage, only enough solution is made up for the day.

All containers of chemical agents are appropriately labelled. This is to ensure that
the contents of containers can be readily identified and used correctly. For this
reason, labels must be kept fixed to the container at all times and clearly
understood.

Specifically, it is recommended that a container with diluted cleaning agent state:

   name, type and purpose of chemical agent
   instructions on preparing and discarding the solution
   warnings and/or health and safety instructions.

Material safety data sheets (MSDS) are made available for all substances used in
our practice as required by State or Territory legislation. The use and handling of
chemicals, including cleaning agents, must comply with the manufacturer‟s
instructions, and these can be found on the label or MSDS.

It is also important that chemicals are stored in a safe area, to prevent
unauthorised access. Check local, state or territory legislation for specific handling
and storage requirements.

Containers of chemicals are stored in a cupboard out of the reach of children. If
the cupboard is below the waist, a childproof lock should be fitted.

Staff members who are required to handle chemicals are trained in their correct
and safe use, and this includes the correct use of personal protective equipment
(PPE).

All chemicals and cleaning equipment is used for the purpose intended and in
accordance with the manufacturers instructions and dilution ratios are strictly
adhered to.

Procedure

Our practice has the listed chemical and cleaning products for the following uses:


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(Practice Name) Policy & Procedure Manual                 Sec.4 Infection Control

 Product                      Use                 Storage location        MSDS
                                                                          available
                                                                               

                                                                               

                                                                               

                                                                               

                                                                               


Material safety data sheets are located (*Insert where your practice stores
Material safety data sheets).

 Hint
Helpful Resources: QbAY >> Treatment Room

          rd
RACGP 3 Edition Standards (Criterion 5.3.4)



4.5      Single use equipment
Policy

Equipment and medications labelled by the manufacturer as disposable or single
patient use are not reprocessed and re-used in this Practice.
This includes, but is not limited to: Oxygen masks and tubing, nebulizer sets,
spacers, razors, spatulas, auriscope tips, liquid nitrogen applicators, pins for
sensory testing and medications such as eye drops and ointment, lancets for
blood testing, and Spirometer and peak flow mouthpieces.
Single use packaging is the only acceptable presentation for dressings, suture
materials, suture needles, hypodermic needles, syringes and scalpels.

Multiple dose containers of local anaesthetic (or other injectable substances)
present an unacceptable infection hazard.




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Items marked by the manufacturer as “single use” must never be reused under
any circumstances. Some items may be reprocessed for use by the same patient
if labelled “single patient use” and in this case the manufacturer‟s instructions for
reuse must be followed. These may include cleaning requirements and limitations
to the number of times the item can be reprocessed.

Single use items or equipment contaminated with blood or body fluid fall within the
category of designated infectious waste and are disposed of accordingly.


Where possible saline solution and skin preps are purchased in single use
sachets or containers. Larger containers, if used, are dated when opened and
changed regularly.
          rd
RACGP 3 Edition Standards 5.3.4


 Hint


Helpful Resources:
    QbAY >> Treatment Room,
        Department of Health and Ageing Infection control guidelines for the prevention of
        transmission of infectious diseases in the health care setting,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                         th




4.6      Instrument and Equipment processing area
Policy

The RACGP Standards recommend a designated area should be used for
processing all instruments and equipment for reuse to prevent possible
contamination of processed items.

A workflow pattern, systematically moving from dirty to clean, must be established
within the designated area. All staff must understand and adhere to the
designated work flow pattern.

The equipment processing area needs to include:

   Adequate bench space with surfaces made of a smooth, non-porus material
without cracks or crevaces to allow for cleaning
   good lighting
   Bins for specific waste
   Adequate storage space for materials and equipment.
   Specified cleaning equipment such as:


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(Practice Name) Policy & Procedure Manual                       Sec.4 Infection Control

  i.        Heavy duty utility gloves, plastic apron to protect clothing, protective
            eyewear and if items are grossly soiled, a mask or visor.
 ii.        A non-corrosive, non-abrasive, free rinsing and mildly alkaline detergent in
            the original container or a clean, well labelled bottle.
 iii.       Cleaning brushes of a suitable size to effectively reach all parts of the item
            being cleaned.
 iv.        Low-linting towelling for drying the cleaned items.

The workflow pattern must enable items to progress from the cleaning area to the
steriliser packaging/unloading and sterile stock storage area without re-
contamination.

Sinks and containers need to be cleaned daily.

Procedure

In our practice, our equipment processing area is located (*Insert location here)
and our facilities include:

(Select from option 1, 2 or 3 depending on which best describes your
practice equipment cleaning facilities. Delete other options

(Option 1) Dedicated double sink with adequate bench space either side for work
to flow from dirty to clean area. A separate hand washing area is also available
elsewhere in the room.

           Use the sink on the dirtiest side (according to the workflow pattern) to
            wash the dirty instruments with the plug inserted. This is the dirty sink.
           Use the other sink to initially rinse the instruments and then for the final
            rinse. Do not insert the plug but rinse under running water.
           Use the separate hand washing area for hand cleansing

 (Option 2) A double sink with adequate bench space either side for work to flow
from dirty to clean area. This sink is also the only area available for hand washing.

           Obtain and label a large plastic container to act as the dirty sink and place
            this on the dirtiest side (according to the workflow pattern)of the existing
            sink .Use this container to wash the dirty instruments in.
           Use the sink directly adjacent to initially rinse the instruments and then for
            the final rinse. Do not insert the plug
           Use the second adjacent sink as a dedicated hand washing area.
OR
           Use the sink on the dirtiest side (according to the workflow pattern) to
            wash the dirty instruments with the plug inserted. This is the dirty sink.
           Use the other sink to initially rinse the instruments and then for the final
            rinse. Do not insert the plug but rinse under running water. This is the clean
            sink
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(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

        The clean sink can also be used for washing hands. However, it must be
         cleaned after washing instruments to render it suitable for hand washing.


(Option 3) A single is sink available to use for cleaning items. Separate hand
washing facilities are available.

        Obtain and label a large plastic container to act as the dirty sink and place
         this on the dirtiest side (according to the workflow pattern)of the existing
         sink .Use this container to wash the dirty instruments in.
        Use the sink to initially rinse the instruments and then for the final rinse.
         Do not insert the plug.
        Use the separate hand washing area for hand cleansing


 (Option 4) A single is sink available to use for cleaning items and washing
hands.

        Obtain and label a large plastic container to act as the dirty sink and place
         this on the dirtiest side (according to the workflow pattern)of the existing
         sink .Use this container to wash the dirty instruments in.
        Use the sink to initially rinse the instruments and then for the final rinse.
         Do not insert the plug
        The sink can also be used for washing hands. However, it must be
         cleaned after washing instruments to render it suitable for hand washing.


Environmental Issues

The area and equipment associated with instrument and equipment processing:

   is only cleaned or managed by appropriately trained Practice Staff
   must remain in a clean and tidy manner throughout the day
   is thoroughly cleaned at the end of the day

If a plastic utility container is used as the Dirty sink for washing the instruments
this container must be treated with due care. The container is not touched with
ungloved hands and it is thoroughly washed at the end of the day as part of the
practice‟s routine cleaning. This container is not to be used for any purpose other
than instrument pre-cleaning

          rd
RACGP 3 Edition Standards 5.3.4
 Hint




                                                          Nov-99, Feb-2001, Dec-2001,
               Feb2003
                                                Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                      Sec.4 Infection Control

If your Equipment processing area provides challenges due to lack of space contact your
local division for additional assistance with options for setting up your equipment
processing area.
Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4th Edition


4.7      Cleaning reusable Instruments and equipment
Policy

A basic risk assessment is required to determine the appropriate level of
processing required for specific instruments. The site/manner where an
instrument will be used can assist in determining the risk of infection. This
analysis determines the level of processing required to minimise the probability of
infection to the patient.
More information to assist with this risk assessment can be obtained from RACGP
Infection Control Standards for Office Based Practices, 4th Edition (page 51)

Staff whose duties require them to process equipment for reuse must have
received adequate training and competency assessment in this area.
More information about aspects that require training and competency can be
obtained from RACGP Infection Control Standards for Office Based Practices, 4th
Edition (page 52)

Thorough physical cleaning of items to remove blood and other debris is needed if
effective disinfection or sterilisation is to be achieved. Preliminary cleaning must
be done as soon as possible during or after use to prevent coagulation of blood
and other proteins.

Any delay will increase the bio-burden (through bacterial multiplication) and also
increases the difficulty of removing adherent soil. The effectiveness of sterilisation
is dependent on the bio-burden being as low as possible.


Procedure

All staff cleaning reusable items:

   Wear appropriate PPE
   Use equipment as specified
   Have received appropriate formal or in house training.
   Are appropriately immunised



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(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

Our practice follows this procedure for all instruments and equipment that is
going to be reused for patient care. This includes items that
 need to be clean but are not required to be sterile for re-use eg kidney
   dishes, ear syringes
 need to be sterilised after use, but not used as sterile eg vaginal
   speculums
    need to be sterile for re-use eg surgical instruments

     Step 1     Wash hands with liquid soap and dry thoroughly with paper or
                single use towel.
     Step 2     Put on personal protective equipment including goggles, plastic
                apron and heavy duty kitchen gloves.
     Step 3     During or immediately after use open instruments and, dry- or
                damp-wipe off gross soil. Rinse the item under gently running tepid
                water over the clean sink.
     Step 4     If unable to clean instruments immediately, open instruments and
                soak in a container with a lid in tepid water and detergent until they
                can be cleaned. Clean instruments as soon as possible as
                prolonged soaking damages instruments. Use fresh water and
                detergent
     Step 5     Prepare dirty sink/basin by filling with sufficient tepid water and the
                correct amount of detergent to cover the items being washed.
     Step 6     Thoroughly wash each instrument in the dirty sink/basin to remove
                all organic matter. Open and disassemble items to be cleaned.
                Keeping items under the waterline to minimise splashing and
                droplets, scrub items with a clean, firm-bristled nylon brush. Use a
                thin brush to push through lumens, holes or valves.
     Step 7     Rinse the washed instruments in gently running hot water over the
                clean sink/basin.
     Step 8     Inspect instruments to ensure they are clean. Look at hinges,
                handles and working surfaces.
     Step 9     Place each washed instrument on a clean lint free cloth or surface
                and repeat the above process until all instruments have been
                cleaned and rinsed.
     Step       Carefully discard dirty water down the sink. If using a container,
     10         aim to pour the dirty water directly into the plughole rinsing the sink
                afterwards with running water.
     Step       Wash cleaning brushes/cloths with detergent and tepid water after
     11         every use. Hang to dry. Can consider sterilising these in the last
                load of the day.
     Step       Wash the dirty and clean sink/basin by rinsing it with tepid water
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(Practice Name) Policy & Procedure Manual                     Sec.4 Infection Control

       12        and detergent. Wipe down the sink/basin with a disposable towel.
       Step      Remove kitchen gloves and replace with non sterile disposable
       13        gloves...Carefully dry each instrument with a clean, lint free cloth.
                 Do not allow to air dry.
       Step      Remove and Clean personal protective equipment by washing or
       14        wiping down and drying.
       Step      Wash hands with liquid soap and dry thoroughly with paper or
       15        single use towel.


          rd
RACGP 3 Edition Standards 5.3.4
 Hint
If your practice uses an ultrasonioc cleaner you will require a protocol for use and
maintenance. Refer to pages 64-66 of the RACGP Infection Control Standards for Office
                   th
Based Practices, 4 Edition, or the current edition of AS/NZS 4815 for information.

Helpful Resources:
    QbAY >> Treatment Room,
   
                                                                        th
         RACGP Infection Control Standards for Office Based Practices, 4 Edition


4.8      Provision of sterile items
Policy

This practice is able to provide assurance that any items provided for procedures
into normally sterile tissue, sterile cavities or the bloodstream are sterile.

This practice understands that sterilisation is more than simply putting loads
through a steriliser and the process of sterility assurance includes all aspects of
equipment reprocessing, and staff education.

 Hint
Helpful Resources:
        QbAY >> Treatment Room,
        Department of Health and Ageing Infection control guidelines for the prevention of
        transmission of infectious diseases in the health care setting,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                         th

          rd
RACGP 3 Edition Standards 5.3.4

Procedure




                                                             Nov-99, Feb-2001, Dec-2001,
                Feb2003
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(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

Option 1: (Select if “single use disposable” instruments are used. Delete
options 2 & 3 and proceed to “4.9 Storage of Sterilised Equipment"
procedure)
This practice purchases single use sterile disposable instruments to use where
appropriate.
It is the responsibility of all staff to ensure that disposable instruments are placed
in the correct waste bins (yellow topped contaminated waste bins) following use.
This waste must be removed from our practice in such manner to prevent patient-
to-patient or patient-to-staff cross contamination.

Appropriate PPE is worn when handling waste.


The batch number of all instruments used is recorded to enable tracking of the
instruments if necessary.
The Class 1 Chemical Indicator and packaging integrity is checked prior to
opening an instrument pack for use.
After using an instrument, replacement stock is ordered to maintain an adequate
stock of instruments for our requirements.
Option 2: (Select if a “off site facility is used to provide sterilisation
services. Delete Options 1 & 3 and proceed to “4.9 Storage of Sterilised
Equipment" procedure)
Policy

Our practice has a supply of reusable instruments that are maintained in good
working order and are free of rust and surface damage. The correct procedures
must be followed to ensure that these instruments are cleaned and sterilised after
each use. We do not have a Steriliser on our premises therefore we have
arranged for the instruments to be autoclaved offsite. Our practice has contracted
(*Insert name of the off site sterilisation providers) to provide this service.
The following documentation is maintained:
     A copy of their current accreditation certificate (eg accredited general
       practice or ACHS accredited hospital)
     An agreement between the practice and off site sterilisation facility stating
       the required duties, washing packaging and transport protocols, turnaround
       time, quoted prices and names of contact people for both organisations.
        A steriliser log book detailing the pack contents, the load number, contents
         of the cycle performed off site, the condition of the pack received back and


                                                         Nov-99, Feb-2001, Dec-2001,
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         the identity of the staff preparing loads for sterilisation and releasing loads
         for use.
        Practice must have appropriate policies and procedures to ensure
         preliminary cleaning of items, packaging and transportation arrangements


Procedure

It is the responsibility of (*Insert staff member‟s name) to co-ordinate the off site
sterilisation arrangements.

1. Ensure that all instruments that require sterilisation are cleaned in accordance
   with the steps outlined in the Cleaning of reusable items” procedure.
2. Items are packaged and labelled prior to despatch to the facility in accordance
   with agreed procedures between both facilities.
3. place all instruments in a plastic container labelled “contaminated” with a firmly
   fitting lid. If items are not cleaned prior, standard precautions must be adhered
   to when handling this container and contents.
4. document all instruments leaving the practice.
5. telephone to inform the offsite sterilisation service provider that a cycle of
   instrument sterilisation needs to be undertaken for our practice and to arrange
   a delivery and pick-up time
6. Use a different plastic container “labelled sterilised items” to collect the items
   from the sterilisation facility
7. on return of the instruments following sterilisation, check the packages for
   damage thoroughly before signing off.
 Hint
The onus of proof is on the practice to ensure that what is happening at the off site facility
meets the RACGP standards. Insert copies of the protocols/guidelines followed by the off
site facility, any agreements between the off site facility and your practice, as well as
evidence of current Accreditation & annual sterilization process validation, of the off site
facility. If a packaging procedure is not issued by the off site facility, personalise the “Pack
content and packaging” procedure then proceed to “Management of Sterile items”.



Option 3: (Select if the practic‟se own steriliser is used to provide sterile
items. Delete Option 1 & 2 )
   Policy




                                                               Nov-99, Feb-2001, Dec-2001,
                Feb2003
                                                     Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                      Sec.4 Infection Control

Our practice has a supply of reusable instruments that are maintained in good
working order and are free of rust and surface damage. The correct procedures
must be followed to ensure that these instruments are cleaned and sterilised after
each use. Our practice uses steam at high temperature under pressure for
sterilising cleaned instruments. This is the most reliable and cost effective method
of sterilisation and is recommended for use in general practice.

   Specific instructions on the packaging and use of the autoclave must be
   displayed next to the machine. These instructions must include a
   comprehensive workflow schedule to ensure that there is no possible
   contamination of the clean areas where the sterile instruments are unloaded
   and stored.

   All items to be sterilised must be thoroughly cleaned first. Our practice
   documents each cycle in a sterilisation log.

   Our portable steam steriliser has a closed door drying cycle that must be used
   when processing wrapped articles so as to ensure that instrument packs are
   dry before unloading.

   Our practice validates our sterilisation process annually at the servicing of the
   steriliser. Refer to Validation of the sterilisation process.

   (*Insert name of staff member) is responsible for correct operation and
   training staff on how to process instruments.


   Holding times for steam sterilisation

   All times are based on the assumption that the items to be sterilised are
   thoroughly clean.

     Temperat       Pressure                Holding time       Penetration       TOTAL
     ure @ C       KPa      psi            for steam          time if           STERILISATI
                                            sterilisation      applicable        ON TIME
                                            (this includes     (as
                                            safety factor)     determined
                                                               by
                                                               technician)
    121C           103        15       15 minutes

    126C           138        20       10 minutes

    134C           203        30       3 minutes
    (wrapped

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    items)


   Reference: Recognised temperature, pressure, time relationships (AS 4185:
   Draft 2005).

   The “holding time” does not include:
         the time taken for heating the load to the desired temperature
         any large volumes of material or heavily wrapped/packaged items
            included in a given load, and
         time taken to allow the inside of the packs to achieve the desired
            temperature.
This is the “Penetration time” and must be added to the holding time.

   STERILISATION TIME = PENETRATION TIME + HOLDING TIME.
 Hint
Helpful Resources:
        QbAY >> Treatment Room,
        Department of Health and Ageing Infection control guidelines for the prevention of
        transmission of infectious diseases in the health care setting,
   
                                                                          th
         RACGP Infection Control Standards for Office Based Practices, 4 Edition

   Packaging of instruments
   Policy

   Our practice ensures the packaging and wrapping of items for sterilisation
   provides an effective barrier against sources of potential contamination in
   order to maintain sterility and to permit aseptic removal of the contents of the
   pack.

   Procedure

   Our practice follows this procedure when packaging instruments:

     Step 1         After instruments have been cleaned and dried, unhinge and
                    open them.
     Step 2         Pack instruments using wrapping, bags or pouches and the
                    following principles:
                        use tip protectors if necessary to prevent sharp instruments
                         from perforating the material
                        if using laminated pouches, pack hollow items such as
                         bowls and kidney dishes with the open side against the
                         paper

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(Practice Name) Policy & Procedure Manual                      Sec.4 Infection Control

     Step 3         Place a Class 1 chemical indicator on the pouch or bag. Note
                    that most pouches have a peel-off strip that is also a Class 1
                    chemical indicator which can be inserted inside the pouch.
                    Pouches or bags should have a Class 1 chemical indicator
                    manufactured on the outside of packaging or steriliser tape can
                    be used.
     Step 4             If the steriliser has a printer, check sufficient paper is in the
                         printer.
                           OR
                        If the steriliser does not have a printer, then a Class 4, 5 or
                         6 chemical indicator must be included in one pouch and/or
                         on the tray.(usually this is into the largest pack or placed in
                         the coolest part of the steriliser chamber)
     Step 5             Remove peel-off strip from pouch and fold exactly along the
                         dotted line.
                          OR
                        Seal or close the pack with sterilisation tape (2-3 folds)
                    OR
                       heat seal to ensure that no air is able to enter.
                    Do not use pins, staples, string or non-adhesive tape to seal
                    packages.
     Step 6         Inspect pack to ensure packaging material is intact.
     Step 7             Use a felt-tip, non-toxic, solvent-based marker pen to label
                         the pack with the date of sterilisation, load number and
                         contents of the package (if opaque packaging). For example
                         the 1st load on the 25th of July 2003 would look like
                         25/07/03–1. If you are using sequential numbering it may
                         look like 25/07/03–456.        OR
                        Adjust the date and cycle number on the sterilising labeller
                         and apply to pack.

     Step 8         Record details in the sterilisation log.
 Hint


Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th




   Loading the steriliser

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               Feb2003
                                                   Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

   Policy

   Correct loading of sterilisers is needed for successful sterilising to:

        allow efficient air removal
        permit total steam penetration of the load
        allow proper drainage of condensation and to prevent wet loads
        prevent damage to items in the load
        maximise efficient utilisation of steriliser
        when loading the steriliser, care needs to be taken that the steam can
         circulate effectively and that all surfaces are accessible and exposed to
         steam. Never load the chamber when it is at 75% capacity

   Procedure

   Our practice follows this process when loading the steriliser:

       Step 1     Load items into the steriliser following these points:
                    allow enough space between each item to allow air removal,
                     steam penetration and drying to occur
                    do not crush items together
                    do not allow items to touch the floor, top or walls of the
                     chamber
                    follow the pattern of loading described in the practice
                     validation protocol when doing a full load.
       Step 2     Fill the chamber with or ensure reservoir has sufficient
                  deionised/demineralised water as per the manufacturer‟s
                  instructions.
       Step 3     Turn on electricity, ensure printer is “on” and has sufficient paper.
       Step 4     Monitor the sterilisation process by one of the following:
                   automatic printout or computerised data logger download
                    (records at a minimum of 60 second intervals)
                   use of a class 4, 5 or 6 chemical indicator with every cycle
                   manually record time and temperature throughout the cycle at
                    least every 30 seconds.
       Step 5     Close and secure chamber door as per manufacturer‟s
                  instructions.
       Step 6     Press “Start” button or relevant button to commence the cycle as
                  per manufacturer‟s instructions.

 Hint

                                                          Nov-99, Feb-2001, Dec-2001,
                Feb2003
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(Practice Name) Policy & Procedure Manual                 Sec.4 Infection Control


Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th




   Sterilisation cycle parameters
The steriliser settings used at our practice are based on the manufacturer
recommendations and Instructions for use, and the results of the validation of the
sterilisation process.
All staff operating the steriliser are conversant with the sterilisation cycle
parameters required to yield sterile items at our practice and the settings/
operation of our steriliser required to achieve this..
*Insert the parameter settings used a your practice and instructions if these
need to be manually set by the operator


  PARAMETER                        CONFIRMED PARAMETER SETTING
                                   FOR ROUTINE WRAPPED LOAD

  Temperature                      134oC

  Total Processing Time:
  (TPT=PT+H)

  Pressure

  Drying Cycle                     activated


Staff are able to interpret printouts or loggers and other monitoring requirements
to ensure these required parameters have been met for every cycle.



   Unloading the steriliser
   Policy

   For items wrapped in porous packaging materials, the period of time between
   their removal from a steriliser (any type) and their return to room temperature
   is recognised as being the most critical time with respect to assurance of
   sterility.

   Cooling generates a tiny flow of room air into the pack at flow rates
   demonstrated to breach porous packaging materials leading to their failure to
   provide a microbiological barrier.
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   Correct cooling practice is needed to maintain sterility. When a sterile item is
   not cooled in the correct manner the article can have moisture build up, which
   can contaminate stock. The item must be reprocessed if the packaging is torn,
   punctured or wet.

   Procedure

   Our practice follows this process when unloading the steriliser:

     Step 1       When cycle is complete, check printout, data logger, or Class 4, 5
                  or 6 chemical indicator to ensure the temperature has reached
                  the parameters of at least 3 minutes at 134c and stayed above
                  134c for the specified period determined during penetration
                  study.
                  Note a minimum of 3 minutes at 134c is required for unwrapped
                  goods. For wrapped, packed or pouched items, these
                  measurements need to be confirmed by a technician, known as
                  penetration time and time at temperature testing at validation.
     Step 2       Circle and sign these parameters on the printout and attach to the
                  sterilisation log.
     Step 3       Open the steriliser door to its maximum to allow contents to cool.
     Step 4       Turn off electricity or as per manufacturer‟s instructions.
     Step 5       Wash hands with liquid soap and dry thoroughly with paper or
                  single use towel or put on clean, dry gloves. Use gloves
                  specifically designed for removing hot sterilising racks from the
                  chamber to prevent staff receiving burns.
     Step 6       Visually examine packages to ensure that:
                   the load is dry
                   the packages are intact
                   the indicators have changed colour.
                  Any items that are dropped on the floor, torn, wet or have broken
                  or incomplete seals are contaminated and must be repackaged
                  and reprocessed.
     Step 7       Take items from the sterilising chamber and place on a cooling
                  rack on a clean field until cool (or allow items to cool inside the
                  chamber once packages have been checked).
     Step 8       Record details in the sterilisation log.
 Hint


Helpful Resources:
                                                             Nov-99, Feb-2001, Dec-2001,
               Feb2003
                                                 Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                    Sec.4 Infection Control

        QbAY >> Treatment Room,
    
                                                                        th
         RACGP Infection Control Standards for Office Based Practices, 4 Edition


    Documentation of the Cycle.

Policy
A sterilisation log is maintained which contains details of:


   Date of cycle
   Steriliser Identification (only if more than 1 steriliser in the practice)
   Load Number.
   Contents of the load
   Identification of the person who prepared the load
   Class 1 Chemical indicator has change
   Condition of the packs. (dry with seals and package integrity intact)
   Evidence of the process such as a print out or class 4,5 or 6 Chemical
    Indicator or if a data download logger is used, sign off that it was viewed
    and is correct
   Signature of the person releasing the load.
   Any comments or problems such as failed cycles and actions taken.


Procedure
   The Loading section of the sterilization log is completed and signed when the
    steriliser is loaded.
 The unloading section of the sterilization log is completed and signed when
    the steriliser is unloaded.
 Sterilisation log sheets are retained and filed according to the procedures for
    medical records.
Failed cycle
In the event of a failed cycle:
   document failed cycle with a brief summary of the problem in the Steriliser
    General Logbook
   notify any other staff members
   Do not use items from the steriliser until the error is rectified
   refer to the troubleshooting guide on the operating instructions
   re-process the instruments
   if fault occurs again contact the service technician for advice and record
    any actions in the Steriliser Maintenance Log Sheet
 Hint



                                                            Nov-99, Feb-2001, Dec-2001,
                Feb2003
                                                  Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                     Sec.4 Infection Control

Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                          th

    Sterilisation log is located at the end of this section in the forms and templates


   Maintenance of the steriliser

Policy
It is critical that the steriliser is maintained by practice staff and service personnel,
in accordance with the steriliser manufacturer‟s instructions and that routine
servicing by suitably qualified person occurs at least annually.
The maintenance procedures must be clearly documented, performed and
recorded on an ongoing basis (daily, weekly and monthly) by practice staff and
service. The operating instructions are located next to the steriliser.(*insert
location if different)


Procedure
Changing the water
Deionised or distilled water is used and the water reservoir is checked prior to use
and drained and refilled weekly.
Cleaning the steriliser
Scale build up and corrosion in the chamber is regularly cleaned using a
phosphoric acid or citric acid solution or paste. Outlet drains are visually
checked to ensure they are free of debris and seals are visually checked for
signs of wear and tear.
Servicing the steriliser
A maintenance contract for servicing of the steriliser is established with
(*Insert Name of Organisation) the steriliser is serviced at least 12 monthly
or more frequently if required and is next due (*Insert month and year).
The servicing companies contact number is (*Insert number and contact
person's name if known).
Validation of the sterilisation process is performed at least annually or more
frequently if required, according to the validation protocol. Usually this is following
the service.

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Documentation
All maintenance and servicing is documented in the maintenance log. This
includes maintenance performed by staff such as changing the water, cleaning
and checking the door seal and outlet drain.
Evidence of validation is documented in the validation certificate in the following
section.
 Hint


Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                         th

    Sterilisation Maintenance log is located at the end of this section in the forms and
        templates



   4.9 Storage of sterilised items

   (Include for Options 1,2&3)

   Policy

   All sterile items, including those processed in the practice facility and those
   procured from commercial supplies, shall be stored and handled in a manner
   that maintains the sterility of the packs and prevents contamination from any
   source.

   Factors that influence shelf life are event-related (not time-related) and are
   dependent on storage and handling conditions.


   Procedure

   Instruments in our practice are stored:

        in a clean, dry and well ventilated area
        in an area free from draughts
        in an area where there is reduced chance of contamination from dust and
         water
        with dust covers should items be stored for a long period of time
        in a manner which allows stock rotation, eg place recently used items at
         the back and take from the front


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        with the contents of the package clearly visible to reduce handling of
         instruments.

   Instruments and items used for procedures in other locations such as aged
   care facilities and home visits are transported to the facility in a separate rigid
   walled container with a lid labelled sterile items. Care is taken to maintain the
   sterility of these while transporting to the facility.

   Waste and sharps or disposable single use instruments are disposed of into
   the appropriate waste stream according to the waste protocols.

   Instruments and items requiring cleaning for reuse are wiped of gross soil at
   the time of use and placed in a separate rigid walled container with a lid
   labelled “dirty items”. These are cleaned as soon as possible in accordance
   with the cleaning of reusable items protocol. This dirty container and items
   within are managed using standard precautions.

          rd
RACGP 3 Edition Standards 5.3.4
 Hint
Do not store sterile items in cupboards or drawers under the steriliser or basins where the
risk of water damage is possible. Consider using disposable sterile items for off site
procedures to avoid transporting contaminated items back to the practice. Take
appropriate waste containers with you.
Helpful Resources:
    QbAY >> Treatment Room,
        Department of Health and Ageing Infection control guidelines for the prevention of
        transmission of infectious diseases in the health care setting,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                         th




   4.10 Monitoring the Sterilisation Process

   (Only applicable to option 3. Delete this section if you selected option 1
   or 2 and proceed to “4.11 Management of waste”)

   Policy

   Monitoring is a programmed series of checks and challenges, repeated
   periodically, and carried out according to a documented protocol, which
   demonstrates that the process being studied is both reliable and repeatable.




                                                             Nov-99, Feb-2001, Dec-2001,
               Feb2003
                                                  Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

   If the temperature or pressure of the steam inside the autoclave is above or
   below what it should be, the steam will not be able to condense and
   sterilisation will be unreliable. The efficiency of the sterilisation process should
   therefore be checked on a regular basis according to the manufacturer‟s
   specifications or those documented in the current edition of AS/NZS 4815.

   Procedure


   Our practice follows these methods of monitoring:

     Test – Processed
     Method           Class 1 chemical indicator
     Frequency        A class 1 chemical indicator must be used for:
                        every wrapped item (external), or
                        every load, if unwrapped.
     Test – Time, temperature and pressure
     Method           Time, temperature and pressure can be measured by
                      using:
                         a steriliser with a print out facility, or
                        data logger/computer download, or
                        manually recording of temperature and pressure
                         throughout the cycle, or
                        Class 4, 5 or 6 chemical indicator (time and
                         temperature only).
     Frequency        Every load
     Test – Calibration
     Method            By a qualified service technician
     Frequency            6 – 12 monthly (or more frequently as per manufacturer‟s
                          instructions)
     Test – Validation
     Method            See definition and process below
     Frequency         12 monthly and as required

         rd
RACGP 3 Edition Standards 5.3.4
 Hint
Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th




                                                         Nov-99, Feb-2001, Dec-2001,
               Feb2003
                                                Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                 Sec.4 Infection Control




Validation of the sterilisation process
   Policy

   “Validation” is a documented procedure for obtaining, recording and
   interpreting results required to establish that the sterilisation
   protocols/procedures followed by our practice will consistently yield sterile
   instruments and equipment, as exactly the same procedure is followed for
   every part of each sterilisation process.

    “Sterilisation” is more than simply putting loads through a steriliser. Successful
   sterilisation to achieve and maintain sterility of equipment and instruments
   reliably and repeatedly is a process which begins with pre-cleaning of
   equipment after use, cleaning of the instruments, drying, packaging, loading
   the chamber, the sterilisation cycle, unloading the chamber, monitoring of
   each cycle, recording cycle details and monitoring in the log book, storage and
   traceability of the sterilised equipment, detection of abnormalities in the
   process and corrective appropriate action, and daily, weekly and annual
   steriliser maintenance.

   Validation covers three activities, which are:
     installation qualification („commissioning‟)
     operational qualification („commissioning‟)
     performance qualification.

   The validation process must be carried out by our practice on installation and
   annually in conjunction with a maintenance contractor. A qualified service
   technician must ensure that all gauges and process recording equipment fitted
   to the steriliser are calibrated using independent test equipment. The
   contractor must also document results of heat distribution studies on an empty
   chamber and conduct a penetration test using our practice‟s challenge pack.

   Validation of the sterilisation processes must be completed as soon as
   possible after the routine annual calibration and service and immediately after
   any of the events listed below:

      commissioning a new steriliser (a service technician should install the
       steriliser according to manufacturer‟s instructions and should then check
       the operation of the machine)
      significant changes are made to the existing steriliser, such as major
       repairs or re-calibration, which could adversely affect the result of the
       sterilisation process



                                                        Nov-99, Feb-2001, Dec-2001,
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                                               Feb-2004, Feb 2005, Feb 2006, Feb 2008
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       changes to any part of the sterilisation process, such as changes to the
        contents, packing or packaging of the “challenge pack” or to loading details
        of the “challenge load”.

   If validation of the sterilisation process is successful then any load
   subsequently processed over the next twelve months can be treated as sterile.
   This is provided that:

       all the validated documented sterilisation procedures continue to be
        followed exactly
       the pack contents, packing, and packaging and chamber loading do not
        exceed the parameters of the validated packs/loading
       each cycle is monitored correctly and no changes are made to any part of
        the sterilisation process, which could adversely affect it.

   Procedure

   Our practice follows this process when conducting validation:

       Step 1       Review and perform your infection control policies and procedures
                    including:
                     workflow issues
                     cleaning of instruments
                     pack contents, packing and packaging
                     loading of the steriliser
                     sterilisation cycle
                     unloading the steriliser
                     storage of sterile items
                     maintenance of the steriliser.
       Step 2       Check that the procedures were successful in terms of
                    performance and reliability and sign-off each one using the
                    validation methodology checklist. Attach the validation
                    methodology checklist to the validation record.
       Step 3       Select the hardest to sterilise items (challenge pack) in terms of
                    product or pack density to create your challenge pack and record
                    details on the validation record.
       Step 4       At time of routine service, request the service person to:
                     calibrate the machine
                     conduct a heat distribution or “cold spots” study in an empty
                        chamber (usually performed only on installation, or available
                        from the manufacturer or otherwise determined by the
                        sterilisation technician)

                                                         Nov-99, Feb-2001, Dec-2001,
                Feb2003
                                               Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

                       obtain the penetration time using a thermocouple or data logger
                        by choosing the hardest to sterilise items in terms of product or
                        pack density to create your challenge pack
                     undertake a time at temperature analysis to ensure the
                        temperature is maintained throughout the entire sterilisation
                        phase.
                     provide servicing/testing documentation detailing the outcome.
                    Where onsite technical support is not immediately available, please
                    refer to the current edition of the AS/NZS 4815.
     Step 5         Using the validation record template, record the following details:
                     date of annual validation
                     batch number and biological indicators
                     cycle that is being used for validation
                     temperature and time at which validation is being done
                     attach your servicing/testing documentation to the validation
                       record.
     Step 6         Select the items that you will include in the load and record details
                    on the validation record including the “challenge pack”.
     Step 7         Label the biological indicators to reflect cycle as follows:
                      1st Cycle label one Indicator 1M (for the 1st Indicator placed in
                       the 1st cycle challenge pack in the middle of the pack) and the
                       other 1C (for the non packed Indicator placed on the tray
                       nearest the coldest part of the steriliser chamber)
                      2nd Cycle label one Indicator 2M (for the 2nd Indicator placed in
                       the 2nd cycle challenge pack in the middle of the pack) and the
                       other 2C (for the non packed Indicator placed on the tray
                       nearest the coldest part of the steriliser chamber)
                      3rd Cycle label one Indicator 3M (for the 3rd Indicator placed in
                       the 3rd cycle challenge pack in the middle of the pack) and the
                       other 3C (for the non packed Indicator placed on the tray
                       nearest the coldest part of the steriliser chamber)
                      the 7th Indicator can be labelled Z. This indicator is never
                       sterilised and is usually placed beside the steriliser whilst the
                       three (3) consecutive cycles are being run. This 7th indicator will
                       prove that the batch of indicators was active.
     Step 8         Place the biological indicators inside the challenge pack and in the
                    coldest spot of the chamber and outside of the steriliser. Record
                    the location in the test indicator diagram on your validation record.
     Step 9         Load the steriliser as documented above and draw or photograph
                    details in the loading diagram on your validation record.
     Step 10        Perform three consecutive, identical loads and cycles including the
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(Practice Name) Policy & Procedure Manual                   Sec.4 Infection Control

                    test indicators as marked. With each load, unpack and repack the
                    challenge pack. All items for each load must be at room
                    temperature.
     Step 11        Send the biological indicators for testing/incubation to the
                    pathology company or use an in-house incubator set at correct
                    temperature for incubation.
     Step 12        Document the findings and investigate any failures (a pass result is
                    100%).
     Step 13        Any load run subsequently and which does not exceed the
                    parameters of the validated load can be treated as a load not
                    requiring biological test indicators.
     Step 14        Attach this checklist to the validation record.

 Hint


Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th




4.11 Management of waste
Policy

Since the introduction of the RACGP Standards for General practices (3rd Edition)
The National Health and Medical Research Council (NHMRC) National Guidelines
for Waste Management in the Health Care Industry published in 1999 have been
rescinded.

The RACGP Infection control standards for Office Based Practices outline policies
and procedures to assist our practice to safely manage waste. We are also aware
of any relevant local, State or Territory and/or Federal regulations that impact on
our waste management.
 Our waste policies include:
     Use of Standard precautions when handling waste
     Correct segregation of waste into three streams: “Clinical”, “Related” and
       “General” waste.
     Storage of waste
     Disposal of waste


Effective and safe waste management is important for infection control and also to
reduce the impact on the environment and reduce costs.

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(Practice Name) Policy & Procedure Manual                Sec.4 Infection Control

All staff receives education regarding the management and handling of waste,
appropriate to their role, including the safe use and disposal of sharps.


These categories are defined as:

   clinical waste has the potential to cause sharps injury, infection or public
    offence and includes: discarded sharps, human tissues (but excluding hair,
    teeth, urine and faeces) and materials or solutions containing free flowing or
    expressible blood. It also includes related waste such as cytotoxic waste,
    pharmaceutical waste, chemical waste and radioactive waste
   General Waste is any waste that does not fall into the clinical or related
    category. And may include office waste, Kitchen waste, urine, faeces, teeth,
    hair, nails, sanitary napkins, tampons, disposable nappies, used tongue
    depressors, disposable vaginal specula, cervical cytology spatulas and plastic
    cytology brushes, nonhazardous pharmaceutical waste (eg out of date saline).
    NB: General waste contaminated with blood or body substances (though not
    to such an extent that it would be considered clinical waste, ie not
    contaminated with „expressible blood‟) must be stored in out of reach or
    access to children.


Procedure

All staff use appropriate personal protective equipment which always includes
gloves as a minimum when handling waste. Clinical waste is removed by trained
staff. Waste, either general or clinical is not compressed by hand.

Clinical waste, includes sharps disposal containers and designated biohazard
bins. These are located in each area where clinical waste is generated. They are
emptied at the end of each day or when full.

Containers used for “non sharp” Clinical Waste in our practice:
   Have a good sealing lid.
   Hand free operation (eg wide open mouth, foot pedal or sensor operated)
   Rigid walls
   Should be lined with a plastic bag (preferably a yellow biohazard identified
      bag)
   Have a biohazard sign affixed to the outside.
   Are located away from the reach of children.

While awaiting collection non sharp clinical waste is double bagged using a
biohazard identified yellow bag and stored securely inside a locked yellow
biohazard identified bin in an area that is separate from clean stores and with
restricted access.


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(Practice Name) Policy & Procedure Manual                 Sec.4 Infection Control

Sharps are defined as anything that can penetrate the skin and some examples
include: needles, scalpels, stitch cutters, glass ampoules, sharp plastic items,
punch biopsy equipment, lancets, wire cytology brushes, razors, scissors and
disposable surgical instruments.

Containers used for disposal of “sharp” clinical waste:
   Comply with Australian standards
   Are placed out of reach of children.
   Cannot be knocked over.
   Are located so that the neck is clearly visible to health professionals when
      disposing on items.
   Have scalpel blade removers securely mounted to the walls.
   Are closed and replaced when the full indicator is reached

While awaiting collection sharps containers are never reopened and are stored
with the other clinical waste for collection.

Related waste
    Cytotoxic products are disposed of into the sharps containers.
    Pharmaceutical waste is disposed of in accordance with the state/
      regulations. Refer to Drugs and Poisons Unit website for more information.
      Usually it is taken to the pharmacy for appropriate disposal.
    Chemical waste such as formalin need to be disposed of according to
      state/territory and local government regulations and OH&S requirements.

This practice has a service agreement, with (*insert name of company), who are
contractors specifically licensed to dispose clinical waste through special burial
and high temperature incineration. The bins are collected every (*Insert
frequency of clinical waste collection). (*Insert name or title,eg principle
Doctor, nurse, practice manager) is delegated responsibility to ensure adequate
stock levels of clinical waste containers are maintained and collection schedules
are timely.

General Waste is segregated at the point of use into recyclable, non recyclable
and shred only waste at the point of use according to the local regulations and
being mindful of privacy.
      Waste contaminated with blood or body fluids, that are not considered
       clinical waste, cannot be recycled and is placed into a bin lined with a bag
       which kept out of reach of children. This is disposed of into the normal
       garbage collection.
      Waste containing sensitive information is shredded in accordance with
       privacy requirements.
      All other eligible recyclable waste, is disposed of into the recycle bin.

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Contaminated general waste and clinical waste is not accessible to children.
(Reference: RACGP, 3rd Edition Standards, p. 76)


 Hint: In some settings wide mouthed sharps containers can be used for all clinical
waste. Please amend this procedure if this is the situation in your practice.


        Helpful Resources: QbAY >> Treatment Room,
    
                                                                        th
         RACGP Infection Control Standards for Office Based Practices, 4 Edition
        Drugs and Poisons Unit information: www.health.vic.gov.au/dpu/reqhealth.htm


RACGP 3rd Edition Standards 5.3.4


4.12        Sharps Management
Policy

Our practice makes every attempt to minimise the risk of injury to both staff and
patients, and prevent the possible transmission of disease by discarded sharps.
Sharps represent the major cause of accidents involving potential exposure to
blood-borne diseases. All sharp items contaminated with blood and body fluids
are regarded as a source of potential infection. Safe handling and disposal of
sharps is essential to protect the operator and staff from injury and possible
transmission of disease. Sharps may be defined as any object or device that
could cause a penetrative injury.

Consideration is given to the purchase and use of devices that significantly
reduce the risk of sharps injury.

The staff member who generates or uses a sharp is responsible for the safe use
and disposal of that sharp. This responsibility cannot be delegated.

Procedure

Sharps disposal containers are placed in all areas where sharps are generated.
Where possible they are located between hip and shoulder height. Sharps are
placed into rigid-walled, puncture-resistant yellow containers that meet the
relevant Australian Standard. Containers are not in a location accessible to
children either when in use or when awaiting collection.

The following procedures are undertaken when disposing of sharps:

   the person using the sharp is legally responsible for its safe disposal

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   sharps must be disposed of immediately or at the end of the procedure
    whichever is most appropriate
   sharps must be placed in a yellow puncture-resistant container bearing the
    black biohazard symbol (AS 4031)
   used sharps must not be carried about unnecessarily
   injection trays must be used to transport the needle and syringe to and from
    the patient
   needles and syringes must be disposed of as one unit
   needles must not be recapped
   needles must not be bent or broken prior to disposal
   containers must not be overfilled as injuries can occur whilst trying to force the
    sharp into an overfilled container – close container securely when at the fill
    line.
   the lid must be sealed once the container is full. For push-on lids, use both
    hands and apply pressure only to the edges of the lid
   sharps disposal units must be conveniently placed in all areas where sharps
    are generated
   sharps containers must not be placed on the floor or in areas where
    unauthorised access or injury to children can occur
   sharps containers must not be placed directly over other waste or linen
    receptacles
   assistance must be obtained when taking blood or giving injections to an
    uncooperative patient or to a child.

For removal and disposal of the sharps container, refer to the instructions
detailed under „Waste Disposal‟ above.


This practice assumes an active role in reducing the opportunities for sharps
injury by purchasing safe equipment whenever such an option is available without
compromising the quality and safety of patient care. Examples include:
        self retracting single use lancets for blood glucose testing
        self retracting canula insertion devices and needleless . IV administration
         systems.
        vacuum blood collection tubes
        scalpel blade removal devices
        plastic ampoules
RACGP 3rd Edition Standards 5.3.4
 Hint
        Helpful Resources: QbAY >> Treatment Room,
    
                                                                        th
         RACGP Infection Control Standards for Office Based Practices, 4 Edition

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                Feb2003
                                                  Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                   Sec.4 Infection Control




4.13 Standard Precautions
Policy

Standard precautions are standard operating procedures that apply to the care
and treatment of all patients, regardless of their perceived or confirmed infectious
status. Standard precautions also apply to the handling of blood and other body
fluids.

Standard precautions are work practices that are used consistently to achieve a
basic level of infection control in all health care settings and all situations.

Standard precautions are designed to protect both patients and staff, and
comprise the following measures:
 hand washing
 use of appropriate personal protective equipment (PPE) for example gloves,
   plastic aprons and eyewear
 use of aseptic technique to reduce patient exposure to microorganisms
 safe management of sharps, blood and body fluid spills, linen and clinical
   waste
 appropriate immunisation of GPs, clinical and administrative staff
 routine environmental cleaning
 effective reprocessing of reusable equipment and instruments
 environmental controls such as design and maintenance

Procedure

All staff involved in Patient care or who may have contact with blood or body fluids
are required to understand and use standard precautions when they are likely to
be in contact with:
    o Blood
    o Other body fluids, secretions or excretions, except sweat (eg urine, faeces)
    o Non intact skin
    o Mucous membranes


RACGP 3rd Edition Standards 5.3.4
 Hint
Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                       th

    Department of Health and Ageing Infection control guidelines for the prevention of
        transmission of infectious diseases in the health care setting
    Prepared and Protected CD/DVD and resources http://www.health.gov.au
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               Feb2003
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(Practice Name) Policy & Procedure Manual                     Sec.4 Infection Control




4.14      Additional Precautions
Policy

Additional precautions are measures used in addition to standard precautions
when extra barriers are required to prevent transmission of specific infectious
diseases.

Additional precautions require:

    „isolation‟ of the infectious source to prevent transmission of the infectious
     agent to susceptible people in the health care setting
    a means for alerting people entering an isolation area of the need to wear
     particular items to prevent disease transmission.

There are three additional precaution categories based on routes of infection
transmission in a health care environment. These are:

    contact precautions
    droplet precautions
    airborne precautions.

Outline of requirements for specified categories of additional precautions

    Requirement       Additional precautions type
                      Airborne         Droplet                  Contact transmission
                      transmission     transmission
 Gloves               None            None                     For all manual contact
                                                               with patient, associated
                                                               devices and immediate
                                                               environmental surfaces
 Impermeable          None                  None               Use when health care
 apron/gown                                                    workers‟ clothing is in
                                                               substantial contact with
                                                               the patient (includes
                                                               items in contact with the
                                                               patient and their
                                                               immediate environment)




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 Requirement          Additional precautions type
                      Airborne          Droplet                  Contact transmission
                      transmission      transmission
 Respirator or       Particulate filter Surgical mask           Protect face if splash
 mask                mask P2 (N95)                              likely
                     For
                     Tuberculosis or
                     pandemic
                     influenza
                     otherwise
                     Surgical mask.


 Goggles/face-       Protect face if        Protect face if     Protect face if splash
 shields             splash likely          splash likely       likely
 Special handling None                      None                Single use or reprocess
 of equipment                                                   before reuse on next
                                                                patient (includes all
                                                                equipment in contact
                                                                with patient)
 Transport of        Surgical mask          Surgical mask     Notify area receiving
 patients            for patient            for patient       patient
                     Notify area            Notify area
                     receiving patient      receiving patient
 Other               Encourage         None                     Remove gloves and
                     patients to cover                          gown, and wash hands
                     nose and mouth                             before
                     when coughing
                     or sneezing and
                     to wash their
                     hands after
                     blowing nose

Adapted from the Department of Health and Ageing Infection control guidelines
for the prevention of transmission of infectious diseases in the health care setting
RACGP 3rd Edition Standards 5.3.4


 Hint
Helpful Resources:
    QbAY >> Treatment Room,
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th

    Prepared and Protected CD/DVD and resources http://www.health.gov.au



                                                              Nov-99, Feb-2001, Dec-2001,
                Feb2003
                                                   Feb-2004, Feb 2005, Feb 2006, Feb 2008
(Practice Name) Policy & Procedure Manual                Sec.4 Infection Control



4.15 Personal Protective Equipment (PPE)
Policy

Our practice uses PPE in all cases where there is potential for a staff member to
come into contact with blood or body fluids. PPE is also used when handling
chemicals such as cleaning products.

Personal protective equipment includes:
     gloves
     masks
     face and eye shields
     gowns and plastic aprons.

All staff have received education in the correct use of PPE and understand:
    The use and type of PPE selected depends on the situation and the risk, and
    Are aware of the correct fitting and removal of PPE and the safe disposal of
     these items.

Procedure

PPE is located (*Insert the location of Personal Protective equipment)
maintenance and reordering of PPE is the responsibility of (*insert staff member
name)

Type of personal protective equipment and its appropriate use

    PPE               Appropriate use
    Disposable       Disposable gloves should be used:
    gloves             when handling blood and body substances or when
                        contact with such is likely
                       when handling equipment or surfaces contaminated with
                        such substances
                       during contact with non-intact skin
                       during venipuncture – although needlestick injury may still
                        occur, the presence of the glove layer could reduce the
                        volume of any inoculum.
    Sterile gloves   Sterile gloves should be used:
                       during any surgical procedure involving penetration of the
                        skin or mucous membrane and/or other tissue
                       when venipuncture is performed for the purpose of
                        collecting blood for culture.
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 Heavy duty          Heavy duty gloves should be used:
 gloves                during general cleaning and disinfection
                       during instrument processing
                       during cleaning blood or body fluid and other substance
                        spills.
 Surgical            Surgical Masks can be used:
 Masks                 during procedures or activities that might result in
                        splashing and the generation of droplets of blood, body
                        substances or bone fragments
                       When there is a risk of droplet transmission of disease.
                                        -   To protect unimmunised staff and patients
                                        -   Worn by the patient to prevent the spread
                                            of disease (suspected or known)
 P2 or N95           Worn by staff when there is a risk of airborne transmission of
 Masks               disease (suspected or known) Tuberculosis and pandemic
 (Particulate        influenza.
 filter masks)
 Protective          Protective eyewear should be used to prevent splashing or
 eyewear             spraying of blood and body fluids into the wearers eyes such
                     as during surgical procedures, venipuncture, or cleaning of
                     spills, contaminated areas or instruments.
                      Worn by staff when there is a risk of airborne/droplet
                      transmission of disease (suspected or known).
 Gowns and           Gowns and plastic aprons should be used when there is a risk
 plastic aprons      of contamination of wearer‟s clothing or skin with blood and
                     body substances such as during surgical procedures,
                     venipuncture, or cleaning of spills, contaminated areas or
                     instrument processing.
                     Worn by staff when there is a risk of airborne/droplet
                     transmission of disease (suspected or known).
 Sterile gowns       Sterile gowns should be used:
                       during procedures that require a sterile field.


All staff use appropriate PPE when undertaking any of the following procedures:
   any examinations requiring contact with mucous membranes
   cleaning or dressing wounds, taking down bandages
   cleaning up after procedures
   preparing instruments and equipment for sterilisation
   assisting with or performing procedures
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   vigorous scrubbing or cleaning of contaminated surfaces
   using chemicals
   taking blood
   handling all pathology specimens before they are bagged
   controlling bleeding.

RACGP 3rd Edition Standards 5.3.4
 Hint
Helpful Resources:
    QbAY >> Treatment Room,
    Prepared and Protected CD/DVD and resources http://www.health.gov.au
    RACGP Infection Control Standards for Office Based Practices, 4 Edition
                                                                    th



    Order of fitting and removing PPE wall chart available from the Prepared and Protected
    CD/DVD and resources http://www.health.gov.au. A Link is also available on the DCGPA
    website or at the end of this section in the Forms, Templates and checklists section

A list of recommended PPE practices should have is available at the end of this section in
the Forms, Templates and checklists section



4.16           Laundry
Policy


All staff at our practice have received education regarding the management of
soiled linen, including when to change linen, the use of appropriate precautions
during handling, and the washing, drying and storage of linen.

Procedure

Linen needs to be changed if:
   A patient requires the use of contact precautions, (eg known or suspected of
    having CAMRSA, scabies or lice)
   Blood or body fluid has been spilt on the linen
   It is visibly soiled.
   Before an operative procedure.
When changing linen:
 Staff use PPE and standard precautions as required
   Care is taken to ensure sharps are not caught up in the linen
Clean linen is located in a clean, dry dust free location away from dirty linen and
items. (*insert location)

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(Practice Name) Policy & Procedure Manual                  Sec.4 Infection Control

Option 1: (select if you purchase all disposable linen for your practice)
This practice uses only disposable linen on all examination couches and patient
treatment areas.
Linen is changed regularly and, provided it does not contain expressible blood or
body fluid, it is disposed of into the normal domestic rubbish.
Any linen that is contaminated with expressible blood or body fluid is disposed of
immediately into the clinical infectious waste bin.
(Please delete the rest of this procedure)
Option 2: Select you wash launder and reuse your linen (delete Option 1)
Used linen is stored in a covered, lined container which is located away from
clean items in the (*insert location) before laundering.
Any linen that is contaminated with blood or body fluids is collected in a plastic
bag before being (*insert option), (A) placed in the used linen receptacle and
rinsed in cold water with oxygenated stain removal at the earliest opportunity, or
(B) disposed of according to the management of waste procedure.
All linen is transported in a leak proof container and a separate clean,
container or basket is used to return laundered linen to the practice.
Linen is washed in a washing machine on a hot or cold cycle using an
activated oxygen based laundry detergent and dried in the dryer.
OR
The laundering is contracted out to a commercial laundry service. A copy of
our agreement is available.


RACGP 3rd Edition Standards 5.3.4
 Hint
Helpful Resources:
    QbAY >> Treatment Room,
   
                                                                       th
        RACGP Infection Control Standards for Office Based Practices, 4 Edition


4.17     Safe handling of pathology specimens
Procedure

The following process is followed when handling pathology specimens:


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   Label and name all containers before use to avoid the need for extensive
    handling after the specimen has been collected.
   after collection of blood and body substances these should be placed in the
    appropriate specimen container, as specified by the testing laboratory
   Wipe the container clean to remove any visible soiling and check specimen is
    correctly identified.
   securely seal to prevent any leakage during transport
   place the container upright in a waterproof bag or container
   take care to avoid contamination of pathology slips by keeping them separate
    from the clinical specimens
   For transport between institutions and interstate, pack the primary specimen,
    surrounded by sufficient material to absorb its contents, in a sealable inner
    container and provide a sealable outer container of waterproof, robust
    material. Label in accord with postal and other transport regulations. Keep cool
    if necessary.

 Hint
Helpful Resources:
    QbAY >> Treatment Room,




                                                       Nov-99, Feb-2001, Dec-2001,
               Feb2003
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(Practice Name) Policy & Procedure Manual                   Sec.4 Infection Control

4.18     Forms, Templates & Checklists



 Infection control Forms, Templates & Checklists (may
                  require customising)
       These are also available to download from www.dcgpacom.au

 1.    Section 4.2             Contents of a spills kit

 2.    Section 4.8             Sterilisation Log (2 options available/ with or
                               without patient item use tracking)
 3.    Section 4.8             Maintenance Log

 4.    Section 4.10            Validation checklist

 5.    Section 4.10            Guidelines for using Biological Indicators in
                               general Practice
 6.    Section 4.8             Off site sterilisation Guidelines

 7.    Section 4.15            PPE checklist




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(Practice Name) Policy & Procedure Manual              Sec.4 Infection Control




       RECOMMENDED CONTENTS OF A SPILLS KIT


Our practice has a spills kit readily available consisting of a
rigid walled container with a lid containing:


 1 small bucket (with water level marked) and pre-
measured amount of detergent* (in a labelled container) to be
made up when necessary
 Utility rubber gloves
 Face and eye protection: Goggles/safety glasses/face
shield/mask
 Disposable or reusable impermeable/plastic apron/gown
 Roll of paper towelling (that retains strength when wet)
 Scrapers (2 pieces of firm cardboard or plastic)
 Hazard/cleaning sign
 Biohazard bag
 Polymerising beads or other absorbent material
 List of contents to assist restocking after use
   Copy of the instructions for cleaning spills
*The detergent used for general instrument cleaning is
satisfactory for treating most spills

(Source: Infection control standards for office based
practices, 4th Edition)

                                                     Nov-99, Feb-2001, Dec-2001,
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              (Practice Name) Policy & Procedure Manual                                  Sec.4 Infection Control

                                                STERILISER GENERAL LOG SHEET



                             LOADING                                              UNLOADING                          GENERAL
                                                                 Class 1     Printout     Package                  Comments
                                                                 Chemical    or Class     integrity,
Date   Load    Contents of the load                  Operator                                          Operator    (validation, failed
                                                                 Indicator   4,5 or 6     seals &
       No.                                           signature                                         Signature   loads,
                                                                 check                    packs dry
                                                                             Indicator                             maintenance etc)
                                                                             checked




                                                                                    Nov-99, Feb-2001, Dec-2001,
                                      Feb2003
                                                                       Feb-2004, Feb 2005, Feb 2006, Feb 2008
             (Practice Name) Policy & Procedure Manual                                               Sec.4 Infection Control

                                                  STERILISER GENERAL LOG SHEET




                              LOADING                                                               UNLOADING                       GENERAL

                                                                                  Class 1            Printout or      Operator    Comments
                                                                                  Chemical           Class 4,5 or 6   Signature
Date   Load No.     Contents of the load/ individual items   Operator signature                                                   (validation, failed
                                                                                  Indicator and
                                                                                                     Indicator                    loads,
                                                                                  Packaging check
                                                                                                     checked                      maintenance etc)

                    Patients name & details for tracking




                                                                                                    Nov-99, Feb-2001, Dec-2001,
                                 Feb2003
                                                                                    Feb-2004, Feb 2005, Feb 2006, Feb 2008
        (Practice Name) Policy & Procedure Manual                              Sec.4 Infection Control

                              STERILISER MAINTENANCE LOG SHEET



Date   Reason for maintenance             Signature of person    Description of maintenance and location of supporting
                                          performing             documentation if applicable.
       (Routine, Servicing, or Repairs)
                                          maintenance




                                                                             Nov-99, Feb-2001, Dec-2001,
                              Feb2003
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(Practice Name) Policy & Procedure Manual                               Sec.4 Infection Control


                                 Dandenong Casey General Practice Association
                            VALIDATION DOCUMENTATION CHECKLIST

This checklist will assist practices with compiling all the relevant information for
sterilization process validation .to ensure they have retained all the required
documentation for accreditation. As items are checked off the original, or a copy,
should be placed in a file or folder with this sheet as the cover, for easy reference by
the surveyor.
TECHNICIANS MAINTENANCE REPORT                                                                       


Organisation

Name of Technician

ID of steriliser (Brand/model, type, serial Number)

Complete routine check of all gauges, valves and filters, steriliser operation(incl. Drying cycle)
calibration and servicing.

Date of servicing and calibration

Heat distribution study (empty chamber) identifying 2 or 3 spots

Penetration time (with challenge load)

Time at Temperature (Physical check of temperature inside challenge pack during the entire
processing time)

Total Processing time required

Parameter settings including drying cycle

WRITTEN POLICIES AND PROCEDURES THAT HAVE BEEN CHECKED IE VALIDATED                                  


Cleaning environment and workflow issues

Pre-cleaning of instruments

Pack contents and packaging

Loading of the steriliser

Steriliser operation and monitoring including settings if applicable

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Unloading the steriliser

Storage of sterile items

Steriliser log that records:    Date for each
                                Load / batch number
                                Contents of the load
                                Routine monitoring results (eg printout)
                                Operators signature
                                Pack conditions and class 1 indicator change
Maintenance log that records: Routine maintenance as per manufacturers instructions
                                Repairs carried out
                                Servicing details

OTHER                                                                                             


Process printout or data logger that records the temperature every 60 seconds or class 4,5 or
6 chemical indicator

Records of staff training and name of staff member or doctor responsible for sterilisation

DETAILS RELATING TO THE 3 VALIDATION TEST CYCLES                                                  


Description of the challenge pack contents and packaging

Diagram showing the placement of packs in the challenge load

Position/location of Biological indicators

Time/date of each validation test cycle

Results of Biological indicators including processed indicators and control




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Guidelines for using Biological Indicators in General
Practice
All practices should have implemented validation of the sterilisation process.
Validation Testing with BIs should be repeated at least annually and also after any major
service or maintenance work.
   PLEASE READ THE INFORMATION SHEET WITH YOUR INDICATORS CAREFULLY
   THE BIOLOGICAL INDICATORS (BIS) USED FOR A TEST MUST ALL BE FROM THE SAME
    BATCH/LOT NUMBER AND BE NOT EXPIRED. (NOTE THE EXPIRY DATE IS EXPRESSED IN
    REVERSE ORDER YEAR/MONTH NOT MONTH/YEAR. THE BATCH/LOT NUMBER IS COMPRISED
    OF THE EXPIRY DATE AND FOLLOWING LETTERS)
   CHECK THE INTERNAL GLASS VIAL IS INTACT PRIOR TO USE AND THAT THE BI USED IS
    SUITABLE FOR YOUR TYPE OF STERILISER
Validation:
Usually 7 BIs are required. Label the BIs before use. One is placed inside the Challenge pack and the other
in the coolest part of the steriliser chamber. This is repeated for 3 consecutive loads. The other BI, the
“positive control”, is not processed.

All the processed BI‟s (usually 6) must be incubated before a result can be read. The positive control BI
should also be incubated to demonstrate that the spores and media solution were viable, the incubator is
operating at the correct temperature, and that all the BIs have been stored correctly.

These Biological Indicators must be incubated to indicate a pass or fail. Once cooled the indicators
are ready to incubate. If you do not have a suitable incubator, arrangements should be made for „off
site” incubation prior to processing the BI so the incubation can begin within 24 hours of use. Usually
the Microbiology department of Pathology Laboratories offer this service. Care should be taken to
ensure the glass vial is not ruptured until immediately prior to incubation

The BI results must be documented on the Validation Record Template Form

Action to take if your Biological Indicator Fails
If the processed Biological Indicator fails (shows growth)
Check the sterilisation parameters have not been inadvertently altered and the steriliser is operated
according to the manufacturer‟s manual. Retest the steriliser immediately using another set of Biological
Indicators. A second failure indicates the steriliser needs to be serviced/repaired and sterility of items
processed since the last successful Biological Indicator test cannot be guaranteed and is in doubt. Any
instruments identified to fit into this category must not be used as sterile and should be resterilised after the
steriliser is repaired and successfully validated.

If the Control Biological Indicator fails (does not show growth):
The storage or incubation conditions of the Biological Indicators used for the test were
compromised.
Repeat the test again using Biological Indicators from a new batch, as the test results are meaningless, and
provide no information about the sterilisation cycle

For further information please contact Rose Griffiths, the Infection Control Support Officer at the DCGPA on
pH 9706 7311



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Off site sterilisation Guidelines

Reusable items should be pre cleaned according to the practice procedure at the point of use.

The items should be wrapped and then sent in a container with a lid to the “off site” facility to be
sterilised. Packaging items prior to dispatching to the off site facility may assist with identifying
your items at the facility.

A separate container must be provided to be used for the return of the sterilised items. These dirty
and clean containers should be clearly labelled so they are not mixed up.

You must have written protocols for the precleaning, packaging and transport of items.

The onus is on your practice to provide evidence that the off site facility maintains adequate
standards. Their current Accreditation Certificate and copies of documentation demonstrating the
annual validation of their sterilisation process should be requested by you and retained in a file.
(For example their sterilisation procedures, and validation record)

The “off site” facility may also request a copy of your precleaning, packaging and transport of
items protocols.

All items denoted as “Single use” should be discarded after use and never cleaned for reuse.

Items that will not be used in sterile procedures or contact non intact skin or mucous membranes
(eg Kidney dishes) must be cleaned according to the precleaning procedure before reuse

Other supplies required for sterile procedures should be purchased as sterile prepackaged
products from a medical supply company. Such items would include dressing trays, extra gauze
and swabs.

Metal vaginal speculums must be cleaned according to the precleaning procedure and sterilised
before reuse. They do not need to be packaged to maintain sterility. Disposable plastic speculums
may be an easier option.

Ensure a sterile speculum is used if a procedure is being performed which requires a sterile set up
such as those, which penetrate the uterine cavity, or involve non-intact mucous membranes such
as insertion of an IUD.

Sufficient supplies of instruments are required to allow for the turnaround time. Extra instruments
and some disposable vaginal speculums may need to be purchased.

The batch/cycle number of all instruments used should be referenced in the patient chart or a log
book to assist in the event of an instrument recall.

Staff need to be fully conversant with these protocols.




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  (Practice Name) Policy & Procedure Manual                                        Sec.4 Infection Control


                                   Dandenong Casey General Practice Association
  Personal Protective Equipment for Respiratory Diseases
                           (PPE)

ITEM                               COMMENTS                                                                        

P2 (N95) mask                      Should be worn by the doctor or practice staff member caring for the sick
                                   person. When fitted correctly a P2 (N95) mask offers protection from disease
                                   spread by droplet and airborne transmission. Fit first: remove last by
                                   touching only the ties. WASH HANDS

Surgical Mask                      Should be worn by the sick person to limit the spread of droplets through
                                   talking, coughing or sneezing. Unless it needs to be removed for examination
                                   purposes, the infectious case should wear a surgical mask when other people
                                   are within 1 metre or are in the same room.

Disposable non sterile gloves      Replace gloves between patient contacts or if they become contaminated or
                                   damaged. Place the gloves over the gown cuffs. Fit last: remove first by
                                   gripping the cuffs. Dispose into appropriate waste. WASH HANDS

Plastic apron                      Useful if gown is not waterproof and splashing of blood, body fluids,
                                   excretions or secretions is anticipated.

Protective eyewear                 For example, goggles/visor/shield. Some protective eyewear can be cleaned
                                   and disinfected for re-use. Refer to manufacturer‟s instructions. Fit second:
                                   remove second.

Long sleeved cuffed gown           Fit third: remove third. When removing, only touch the inside of the gown;
                                   pull from the neck and shoulders, then arms, turning inside out as gown is
                                   removed. Discard into the appropriate waste.

Cap                                Useful in high risk situations where there may be increased aerosols.

Alcohol based wipes                For cleaning surfaces. If visible soiling present then refer to your spills
                                   protocols.

Alcohol-based hand rub.            Hand hygiene is the single most effective way to prevent the spread of
                                   infection. Wash hands before putting on PPE, after removing gloves and when
                                   all PPE removed.




       Based on resources from the Australian Government Department of Health and Ageing. November 2005
  Order of fitting and removing PPE wall chart available from the Prepared and Protected
  CD/DVD and resources http://www.health.gov.au.




                                                                                 Nov-99, Feb-2001, Dec-2001,
                      Feb2003
                                                                  Feb-2004, Feb 2005, Feb 2006, Feb 2008

				
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