1996--No. 179 PODIATRISTS ACT 1989--REGULATION (Relating to infection control standards) NEW SOUTH WALES [Published in Gazette No. 61 of 17 May 1996] HIS Excellency the Governor, with the advice of the Executive Council, and in pursuance of the Podiatrists Act 1989, has been pleased to make the Regulation set forth hereunder. Andrew Refshauge Deputy Premier and Minister for Health. Commencement 1. This Regulation commences on 8 July 1996. Amendments 2. The Podiatrists Regulation 1995 is amended: (a) by inserting after clause 2 1 the following clause: Infection control standards 21A. A registered podiatrist must not, without reasonable excuse, fail to comply with the infection control standards set out in Schedule 1 to the extent that they apply to the registered podiatrist in the practice of podiatry. (2) In determining whether or not a registered podiatrist has a reasonable excuse for failing to comply with a standard, particular consideration is to be given to whether the podiatrist's employer failed to provide the necessary equipment, including providing access to it and training in its use, that would have enabled the podiatrist to comply with the standard (and whether the failure to provide such equipment was reported by the podiatrist to the Director-General of the Department of Health). 2 1996-No. 179 (b) by inserting at the end of the Regulation the following Schedule: SCHEDULE 1--INFECTION CONTROL STANDARDS (Cl. 21A) Part 1--Preliminary Definitions 1. (1) In this Schedule: "body substance" includes any human bodily secretion or substance; "invasive procedure" means any one or more of the following: (a) surgical entry into body tissue, cavities or organs; (b) surgical repair of traumatic injuries; "patient" includes (but is not limited to) a person who is accessing medical or health services or who is undergoing any medical or health procedure; "sharps" means any object capable of inflicting penetrating injury, and includes hollow bore needles, suture needles, scalpel blades, wires, trocars, auto lancets, stitch cutters or broken glassware. (2) The requirements set out in this Schedule apply to a registered podiatrist who is assisting in performing a procedure in the same way as they apply to a registered podiatrist who is actually in performing the procedure. Part 2--General standards applying to registered podiatrists General precautions and aseptic techniques 2. ( 1 ) Procedures must be followed in order to avoid direct exposure to a patient's blood or other body substances. This requirement applies regardless of whether there is any perceived risk of infection. (2) Aseptic techniques must be used in the course of complying with the requirements of this Schedule. Hand and skin washing 3. ( 1 ) Hands must be washed and dried immediately before and after any direct patient care. (2) Hands or other skin surfaces that are contaminated with a patient's blood or other body substance must be washed as soon as i t is practicable to wash them. 3 1996--No. 179 (3) The requirement to wash and dry hands applies regardless of whether gloves are also required to be worn. Protective gowns and aprons 4. A gown or apron made of impervious material must be worn during any procedure where there is a likelihood of clothing being splashed or contaminated with blood or other body substances. Gloves 5 . (1) Gloves must be worn while handling blood or other body substances. (2) In particular, gloves must be worn: (a) during any procedure where direct contact is anticipated with a patient's blood or other body substances, mucous membranes or non-intact skin; and (b) while suctioning a patient; and (c) while handling items or surfaces that have come into contact with blood or other body substances; and (d) while performing an invasive procedure, venipuncture or a finger or heel stick; and (e) during any procedure where skin penetration is anticipated. (3) Sterile gloves must be worn if the procedure involves contact with sterile tissue. (4) Gloves must be changed and discarded: (a) as soon as they are torn or punctured; and (b) after contact with each patient. (5) Gloves must also be changed if separate procedures are being performed on the same patient and there is a risk of infection from one part of the body to another. Masks and protective eye wear 6. ( 1 ) A mask and protective eye wear must be worn while performing any procedure where there is a likelihood of splashing or splattering of blood or other body substances. (2) In cases where a mask is required to be worn, it must be worn and fitted in accordance with the manufacturer's instructions. (3) A mask must be discarded once it has been worn and i t must not be used again. 4 1996--No. 179 Sharps 7. (1) Sharps must not be passed by hand between a registered podiatrist and any other person. However, this requirement does not apply if, in any case involving an invasive procedure, the proper conduct of the procedure would be adversely affected. (2) A puncture resistant tray must be used to transfer sharps. (3) A needle must not be removed from a disposable syringe for disposal, or be purposely broken or otherwise manipulated by hand, unless: (a) it is necessary to remove the needle for technical reasons; or (b) the registered podiatrist is performing a procedure where a needle is required to be bent. (4) A needle must not be bent after it is contaminated with blood or body substances. (5) In any case where resheathing of a needle is required: (a) the needle must be properly recapped; and (b) the sheath must not be held in the fingers; and (c) either a single handed technique or forceps, or a suitable protective guard designed for the purpose, must be used. (6) Reusable sharps must, immediately after being used, be placed in a puncture resistant container specially labelled for that purpose. (7) Non-reusable sharps must, immediately after being used, be disposed of in a puncture resistant container. Management of waste 8. ( 1 ) Contaminated waste must be segregated. placed in a suitable leak proof bag or container and contained at the place i t is generated before being disposed of in an appropriate manner. Contaminated waste includes microbiological waste or pathological waste, or any material or item (for example, sharps, dressings or disposable linen) that is soiled or contaminated with blood or other body substances and that is likely to cause infection or injury to any person. (2) Splashing or contamination of skin while disposing of blood or body substances must be avoided as far as practicable. 5 1996--No. 179 Part 3--Specific standards applying to registered podiatrists Sterile medications and solutions 9. (1) A medication or solution may only be taken from a multi-dose vial or ampoule (or other similar container) if the medication or solution is not readily available in another form. (2) If any medication or solution is taken from a multi-dose vial or ampoule (or other similar container), a sterile needle and syringe must be used to withdraw the contents. (3) The needle and syringe must be discarded once the needle and syringe have been used. (4) Precautions must be taken to ensure that the injection of contaminated material or fluid into a multi-dose vial or ampoule (or other similar container) does not happen. Invasive procedures 10. (1) In cases where it is technically feasible, retractors must be used for exposure and access during an invasive procedure. (2) Fingers must not be used for the purposes of an invasive procedure to expose or increase access for the passage of a suture. (3) Only one sharp at a time is to be placed in a puncture resistant tray that is being used in connection with an invasive procedure. Part 4--Processing of instruments and equipment Cleaning of instruments and equipment 11. (1) Any instrument or equipment that comes into contact with intact skin must be cleaned before it is used. (2) Any instrument or equipment that is required to be sterilised or disinfected must be cleaned before it is sterilised or disinfected. (3) The process of cleaning must involve water, mechanical or physical action (such as an ultrasonic cleaner) and a cleaning agent (such as detergent or a proteolytic enzyme). Disinfection of instruments and equipment 12. ( 1 ) Any instrument or equipment that comes into contact with non-sterile tissue (other than intact skin) must be disinfected before it is used. They should also be sterilised if they are capable of withstanding that process. (2) The process of disinfection must involve either thermal or chemical methods. Chemical disinfection may only be used in cases where thermal methods are unsuitable. 6 1996--No. 179 Sterilisation of instruments and equipment 13. (1) Any instrument or equipment used to enter, or that is capable of entering, tissue that would be sterile under normal circumstances, or the vascular system of a patient, must be sterilised before it is used. (2) The method of sterilisation must be compatible with the particular type of instrument or equipment. (3) If the method of steam under pressure (i.e. moist heat sterilisation) is used, the recommended temperature/pressure holding time must be attained and the relevant manufacturer's instructions must be followed. (4) If a dry air oven is used, the instrument or equipment must be held for at least 1 hour at 160 degrees celsius and the relevant manufacturer's instructions must be followed. (5) Instruments and equipment may be sterilised chemically, by using low temperature hydrogen peroxide plasma in a 75 minute cycle, or by using ethylene oxide, or by using low temperature peracetic acid in a sealed chamber in a 30 minute cycle. EXPLANATORY NOTE The object of this Regulation is to specify the standards for controlling infection that are required to be followed by registered podiatrists in the practice of podiatry. The standards are designed to enhance protection of patients against HIV infection and other infectious diseases. The standards to be followed include general requirements (e.g. hand washing before and after direct patient care, wearing gloves while handling blood or other body substances, and proper handling of sharps). The standards also require the cleaning, disinfection and sterilisation of instruments and equipment. This Regulation is made under the Podiatrists Act 1989, including section 34 (the general regulation making power, in particular section 34 (2) (l)).