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ORAL HEALTH STERILIZING ASSESSMENT TOOLDistrict: Oral Health facility: Date:
CRITERIA RISK RATING &ACTIONS REQUIRED
REVIEW DATE BY WHOM
1. OPERATIONS1.1 CLEANING REUSABLE DENTAL INSTRUMENTS & EQUIPMENT1.1.1 All reusable items are cleaned in an area physically separate to other areas within the sterilizing processing facility Building and Refurbishment
1.1.2 Before reusable items are returned to the sterilizing processing facility gross soil such as blood, body fluids and skin preparation solutions are removed as close as possible to the point of use by either dry wiping, damp wiping and rinsing or both. Cannulated instruments must not become dry. QH D&S ICG Section 1
1.1.3 Collection trays/trolleys for the collection of used reusable items are puncture and leak resistant with a lid or liner that can be securely closed SOP1.1 & QH D&S ICG Section 1
1.1.4 The collection container/trolley is cleaned at the end of each collection round of used reusable items SOP1 & QH D&S ICG Section 1
1.1.5 All items that have been unwrapped are considered to be contaminated and must undergo a full cleaning process SOP1
1.1.6 All items including specialised items (eg. powered tools, multi-part instruments) are cleaned in accordance with manufactures guidelines and appendix’s B&C of AS/NZS 4187:2003 and 4815:2006 SOP1 & Cleaning Complex instruments
1.1.7 In order to prevent damage to the surfaces of instruments or residual cleaning residue, abrasive cleaners such as steel wool or abrasive cleaning powders are not to be used SOP1
1.1.8 Chemicals are packaged and dispensed in a safe manner which prevents contamination SOP1
1.1.9 Cleaning methods within the department do not generate aerosols nor add to the formation of bioburden SOP1
1.1.10 Prior to the cleaning, items are sorted according to type and cleaning method plus instrument trays are checked for completeness and defects SOP1
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1. OPERATIONS cont.1.1 CLEANING REUSABLE INSTRUMENTS & EQUIPMENT1.1.11 Cleaning methods used are appropriate for the design of the items being processed.
1.1.12 Any defective instruments are cleaned, dried and sterilized prior to being sent for repairs SOP1
1.1.13 At the completion of the cleaning process, items are visually inspected to ensure they are clean and free from detergent residue SOP2
1.1.14 All equipment and instruments undergo a mechanical cleaning process appropriate for the item and the items are processed for the complete cycle SOP1
1.1.15 Automated washer disinfector machines have the following cycles: pre-rinse with water wash, in warm water and cleaning agent as per manufacturers
recommendations one or more rinses with hot water at 80°C-90°C, with drying
agent added drain, leaving contents at a temperature for quick drying drying, either by radiant heat from an element or hot air blast
SOP1 brackets for hand pieces
1.1.16 Each time the ultrasonic cleaner is filled, water is added first, then the manufacturers recommended detergent followed by degassing of the machine before instruments are placed in the basket for processing SOP1
1.1.17 An ultrasonic cleaner is used to clean jointed, serrated, cannulated instruments not insulated instruments, mirrors or lenses SOP1
1.1.18 When items are removed following being cleaned in an ultrasonic they are rinsed in warm to hot water prior to drying SOP1
1.1.19 The ultrasonic solution is replaced at least daily or when the solution is contaminated SOP1
1.1.20 Safety instructions are followed during the operation of all mechanical washers eg mechanical lifters for heavy equipment, lid is kept closed during ultrasonic operation and no part of the operators body is submerged inside the water tank of an ultrasonic cleaner during operation SOP1
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1.1.21 At the end of each cleaning session the manual cleaning equipment is cleaned and thermally disinfected or sterilized SOP1
1.1.22 Powered instruments and hoses are cleaned as follows- kept clean during surgical procedure cleaned with disposable low-lint cloth, detergent and water not immersed in water not placed in a mechanical washer hose and handpiece to stay attached during cleaning inspect for wear and tear detergent rinsed off items drying cabinet to dry items test prior to sterilization damaged tools and hoses sent for repair by a qualified person
SOP1
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 16/22)
INADEQUATE (<70%)
1.1 OVERALL COMMENTS FOR THIS SECTION:
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1. OPERATIONS cont.1.2 PACKAGING & WRAPPING1.2.1 Individual packs do not include combinations of hollowware, instruments, dressings, drapes or tubing SOP2
1.2.2 Instruments with hinges or ratchets are opened and unlocked prior to packing SOP2
1.2.3 Instruments with multiple parts are dismantled or loosened prior to being packed in accordance with manufacturers instructions SOP2
1.2.4 When packaging instruments sets with delicate items, these items are protected to prevent damage SOP2
1.2.5 When packaging sharp instruments the tips are protected to prevent the perforation of the flexible packaging material SOP2
1.2.6 When packaging instruments that require lubrication the lubricant is water miscible, compatible with the sterilizing process and used in accordance with manufacturers instructions SOP1
1.2.7 When packaging hollowware- all openings face in the same direction non-porus spacers are used to separate each piece of
hollowware contents cannot move inside the pack SOP2
1.2.8 When packaging powered instruments and hoses- lubricate only as necessary, not inside the hose and follow
manufacturers instructions test prior to sterilization disassemble prior to sterilization hoses are loosely coiled SOP1
1.2.9 When determining size, mass and contents of items, consideration is given to the sterilizers ability to- effectively sterilize the pack facilitate the drying process of the pack establishing the efficiency of air elimination from the load SOP2
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1. OPERATIONS cont.1.2 PACKAGING & WRAPPING1.2.10 Prior to use, textile wraps are laundered and checked for holes or threadbare patches SOP2
1.2.11 Only textile wraps as specified in AS3789.2, AS3789.8, AS1079.2, AS1079.5 are used QH D&S ICG Section 2
1.2.12 Hollowware (gallipots) are placed with opening against the paper side of the flexible wrapping material SOP2
1.2.13 Nylon packaging material is only used with a dry heat sterilizer QH D&S ICG Section 2
1.2.14 Methods used to wrap items complies with AS 4815:2006
1.2.15 The method used to seal packs include heat sealers and sterilizing indicator tape SOP2
1.2.16 Only suitable equipment is used for heat sealing bags and flexible packaging materials SOP2
1.2.17 After heat sealing packs the seal is checked to ensure that it is complete (especially over gusset folds of bags or pouches)SOP2
1.2.18 Only non-toxic solvent based felt-tipped marking pens and/or rubber stamps using similar ink are used for labelling packs prior to processing SOP2
1.2.19 Each packaged item labelling includes- contents of pack batch control data - Sterilizer identification number, date of
sterilization and cycle or load number an additional batch control label is included in the sterilizer
cycle record book the treating clinician places the batch control label or barcode
from the packaged item into the individual patients record SOP3
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1. OPERATIONS cont.1.2 PACKAGING & WRAPPING
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 13/19)
INADEQUATE (<70%)
1.2 OVERALL COMMENTS FOR THIS SECTION:
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1. OPERATIONS cont.1.3 STERILIZING EQUIPMENT1.3.1 The methods for processing used in the sterilizing facility includes (please identify)- steam under pressure dry heat
1.3.2 The sterilizing cycle and temperature reflects the type of load and wrapping material QH D&S ICG Section 3
1.3.5 Portable sterilizers without a drying cycle are only used for processing unwrapped items QH D&S ICG Section 3
1.3.6 Portable sterilizers with a drying cycle are used to process small numbers of simple packs QH D&S ICG Section 3
1.3.7 Dry heat sterilizers are used only to sterilize anhydrous items and items sealed in impermeable containers which can not be sterilized by steam under pressure QH D&S ICG Section 3
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 5/7)
INADEQUATE (<70%)
1.3 OVERALL COMMENTS FOR THIS SECTION:
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1. OPERATIONS cont.1.4 LOADING A STERILIZER1.4.1 When loading a sterilizer, space is left between items being processed and the items do not come in contact with the chambers walls SOP3
1.4.2 Loading patterns and loading techniques are consistent with the sterilizers loading pattern during Performance Qualification (PQ) SOP3
1.4.3 Flexible packaging material is loaded on the edge of the laminate or placed flat with the paper surface downwards SOP3
1.4.4 Once the sterilizer is loaded the cycle is commenced and monitored for the entire cycle SOP3
Portable (benchtop), downward displacement and pre-vacuum sterilizers1.4.5 Hollowware is tilted on its edge at a 45º angle in a draining position and not placed above textile packs QH D&S ICG Section 3
1.4 6 Packs of drapes are loaded with layers vertical QH D&S ICG Section 3
1.4.7 Only a single layer of packs is placed on the loading tray QH D&S ICG Section 3
1.4.8 Items to be sterilized unwrapped are placed on a perforated mesh tray flat on the sterilizer shelf with a new chemical indicator placed in the loading tray (dependent on validation of the sterilizer) QH D&S ICG Section 3
1.4.9 A “control” pouch, containing a class 5 or 6 chemical indicator and batch label attached, shall be included in all sterilization cycles. It is not required in test cycles such as vacuum/leak test and air removal steam penetration tests e.g. Bowie Dick type tests (as per direction from the Chief Dental Officer, Jan 2010) SOP 3.2
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1. OPERATIONS cont.1.4 LOADING A STERILIZER
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 7/9)
INADEQUATE (<70%)
1.4 OVERALL COMMENTS FOR THIS SECTION:
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1. OPERATIONS cont.1.5 UNLOADING OF STERILIZERS1.5.1 The sterilizer door is not opened prior to completion of the processing cycle SOP3
1.5.2 Cooling items are placed on racks not solid surfaces SOP3
1.5.3 Processed items are cooled before being place into new polyethylene dust covers and sealed SOP3
1.5.4 The sterilizing parameters are checked prior to a load being released SOP3
1.5.5 A sterilization cycle record is made for each cycle and shows specific contents and signatures of responsible persons SOP3
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 4/5)
INADEQUATE (<70%)
1.5 OVERALL COMMENTS FOR THIS SECTION:
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1. OPERATIONS cont.1.6 STORAGE AND HANDLING OF PROCESSED ITEMS1.6.1 Sterile items are not stored in ultraviolet cabinets or in disinfectants QH D&S ICG Section 2
1.6.2 All unwrapped medical items (including critical, semi-critical and non-critical) undergo a cleaning and sterilizing process prior to being stored in a clean dedicated container/draw QH D&S ICG Section 2
1.6.3 Storage containers, trolley and cupboards are clean, dry and in good condition (cardboard boxes are not used) SOP4
1.6.4 Access to the sterile stock area is restricted SOP4
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 3/4)
INADEQUATE (<70%)
1.6 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE2.1 CLEANING PROCESS & EQUIPMENT2.1.1 The water supply is potable and good quality SOP 5.1 & QH D&S ICG Section 2
2.1.2 The detergents and drying agents used in instrument cleaning are compatible with the quality of clean water supply SOP1.3 & QH D&S ICG Section 2
2.1.3 Cleaning agents are used as recommended by the manufacturer for their intended purpose: acid-based agents are only used for stainless steel surfaces; enzymatic cleaners used for sensitive equipment; household detergents are not usedSOP 1.3 & QH D&S ICG Section 2
2.1.4 All mechanical cleaning equipment have daily checks of washer/disinfector function and detergent and rinse additivesSOP 1.10 & SOP 5.4
2.1.5 Automated washers disinfectors used to process semi-critical items intended for immediate use achieve the following time-temperature combination SOP 1 & SOP 5 QH D&S ICG Section 5
Surface T° Time90° C 1min80° C 10min75° C 30min70° C 100min
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 4/5)
INADEQUATE (<70%)
2.1 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.2 MINIMUM STANDARDS FOR MONITORING OF MECHANICAL CLEANING EQUIPMENT2.2.1 Automated washer disinfector machines- documented time at temperature check every cycle if thermal disinfection required continuous performance checks for - T° and cleanliness of
items to be checked after each load documented daily test for chemical residue SOP5
2.2.2 Ultrasonic cleaner- daily performance testing and documentation – aluminium foil
test or pencil load or other test methods as per manufacturers instructions SOP5
2.2.3 Monitoring item cleaning and daily routine cleaning, checking cleaning equipment efficiency testing SOP5 daily surface cleaning checking and cleaning filters, door seals, jets, doors, door
gaskets, base plates detergent and rinse dispensers are clear and functioning detergent and rinse additives are checked daily and
replenished as necessary continuous checks of switches, gauges and lights SOP5
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 2/3)
INADEQUATE (<70%)
2.2 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.3 PACKAGING & WRAPPING2.3.1 Each packaging and wrapping material used has been tested to establish penetration rates and drying characteristics QH D&S ICG Section 2
2.3.2 All packaging and wrapping materials selected are compatible with the item being sterilized and the sterilizing process QH D&S ICG Section 2
2.3.3 Sterilizing indicator tape used for packaging has the following is compatible with the selected wrapping material used when processed changes colour which is uniform distinctly different from the unprocessed tape has the name of the manufacturer, batch number and date of
manufacturer clearly marked on its core is heat, moisture stable and permeable to sterilizing agents only used to seal bags or laminating pouches in the event of
breakdown of heat sealing equipment as per figure 3.3 page 34 AS/NZS 4815:2006 SOP2 & QH D&S ICG Section 2
2.3.4 Heat sealer- daily check for seal integrity pre and post sterilizing QH D&S ICG Section 2
2.3.5 The rigid containers used to pack items for sterilization allows for steam penetration and the removal of sterilizing agents plus has the ability to ensure sterility QH D&S ICG Section 2
2.3.6 Rigid containers have the following properties- all components are easily disassembled for cleaning, drying
and storage for benchtop steam sterilizers, the base and lids are
perforated containers are compatible with cleaning and sterilization
methods and equipment adequate trials have been undertaken to assess use of the
container system onsite testing using physical & biological testing, & efficiency
of drying cycle have been established during Performance Qualification
containers are not damaged QH D&S ICG Section 2
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2. QUALITY ASSURANCE cont.2.3 PACKAGING & WRAPPING
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 4/6)
INADEQUATE (<70%)
2.3 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.4 STERILIZING EQUIPMENT2.4.1 Dryness fraction of the sterilizers is 97% or above (a dryness fraction below 97% is associated with wet packs in steam sterilization) - for large sterilizers only QH D&S ICG Section 3
2.4.2 Steam is not superheated i.e. not heated beyond 2°C above the sterilizing temperature QH D&S ICG Section 3
2.4.3 Penetration times have been established and added to the holding times (121°C - 15mins, 132°C – 4 mins, 134°C – 3 mins) see page 36, AS/NZS 4815 QH D&S ICG Section 3
2.4.4 On completion of the sterilizer drying stage the load is immediately removed from the sterilizer and the following actions occur: visual inspection of load occurs noting that the load is dry,
seals are intact, correct labelling of the items and the sterilizing indicators have changed to the required colour
recording charts and print outs are checked and the sterilizers recording sheets are signed
loading cars with cooling items are not placed in a high activity area
recently processed items are not assisted to cool by means such as fans or boosted air-conditioning SOP3
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 3/4)
INADEQUATE (<70%)
2.4 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.5 STERILIZER MONITORING & RECORDS 2.5.1 Daily routine checking and cleaning program for each type of sterilizer- floor of sterilizer is free of debris recording devices are functioning correctly door gasket is undamaged air filter is clean- if applicable chamber drain (if present and applicable) humidity reservoir, if externally fitted and applicable distilled water container, if fitted- and applicable lid seal and carrier undamaged vaporizer system (if applicable) SOP5
2.5.2 Records are kept for each sterilizing cycle, which includes date of cycle sterilizer number or code exposure time, temperature and pressure name or identification of loading operator name or identification of person authorised to release load
contents form the sterilizing processing facility specific contents of load including all packs, all items and all
trays/cassettes readout results of physical, chemical or biological/enzymatic
indicators used SOP3
2.5.3 Pre-vacuum sterilizer- every pack has an external chemical indicator each cycle has an electronic printout daily leak rate test where no air detector daily Bowie Dick test weekly leak rate test if air detector SOP5
2.5.4 Downward displacement (Jacketed) and portable bench-top sterilizers with drying cycle- every pack has an external chemical indicator every cycle has an electronic printout QH D&S ICG Section 3
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2. QUALITY ASSURANCE cont.2.5 STERILIZER MONITORING & RECORDS
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 6/8)
INADEQUATE (<70%)
2.5 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.6 STERILIZER COMMISSIONING & VALIDATION 2.6.1 On commissioning of a sterilizer the following tests and checks are performed- installation qualification operational qualification performance qualification of the sterilizer certification of performance qualification of the sterilizer QH D&S ICG Section 4
2.6.2 Recommissioning is performed when engineering work that may have altered the performance of
the sterilizer when routine monitoring records, testing and performance prequalification indicates data outside the original parameters determined during validation QH D&S ICG Section 4
2.6.3 Performance qualification (PQ) is performed when- after commissioning whenever change to product, package to be processed or
changes to loading pattern 12 months (depending on calibration history) QH D&S ICG Section 4
2.6.4 Installation qualification consists of - environmental temperature and humidity is maintained within
specified limits there is no evidence of interference from or to other
equipment during the sterilizing cycle accuracy of T° and/or pressure measurement are within
specified limits when verified by calibration QH D&S ICG Section 4
2.6.5 Operational qualification consists of- when operated with an empty chamber, the T° and pressures
recorded and indicated throughout the sterilizing cycle on instrumentation permanently fitted to the sterilizer, compare with specified limits determined for that process
air detector is functioning bowie dick tests are run for air removal (pump function) microbiological lethality is determined via placement of
biological/enzymatic indicators in identified cold spots QH D&S ICG Section 4
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2. QUALITY ASSURANCE cont.2.6 STERILIZER COMMISSIONING & VALIDATION 2.6.6 Performance Qualification consists of- achieve the minimum sterilizing assurance level (SAL) 10-6 documentation of heat distribution date and time when each of the three performance
qualification cycles were run identification of sterilizer & cycle and process parameters
selected- T°, time and pressure description of loads to be processed (over page) location and position of all temperature sensors and
biological/enzymatic indicators performance of heat penetration studies into each nominated
type of sterilizer load for reusable oblong or square based rigid containers the
placement of physical, chemical and biological/enzymatic indicators into each corner of the container
investigations and corrective actions taken if any cycle fails name and signature of person undertaking the PQ the name and signature of the person confirming the results
QH D&S ICG Section 4
2.6.7 There is documentary evidence of commissioning and recommissioning performance qualifications reports
2.6.8 Certification of validation records include- copy of the original specification of the sterilizer and
subsequent changes location and unique identification of the sterilizer documentation to demonstrate safety specifications
compliance pressure vessel certificates operating instructions copies of test certificates verification of calibration of all instruments fitted to the
sterilizer instillation instructionsapproved test report of validation QH D&S ICG Section 4
2.6.9 A system is evident for the routine calibration of the sterilizer by a trained competent person QH D&S ICG Section 4
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2. QUALITY ASSURANCE cont.2.6 STERILIZER COMMISSIONING & VALIDATION 2.6.10 All associated equipment used within the sterilizing processing facility undergoes regular validation commissioning/recommissioning performance qualification/requalification processes QH D&S
ICG Section 4
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 7/10)
INADEQUATE (<70%)
2.6 OVERALL COMMENTS FOR THIS SECTION:
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2. QUALITY ASSURANCE cont.2.7 STORAGE STERILE STOCK2.7.1 Storage areas for sterile items are – dedicated for sterile storage only are dust, insect and vermin free have open shelving that is 250mm above floor level and
440mm from ceiling fixtures protected from sunlight SOP4
2.7.2 Temperatures and humidity within the sterile storage areas are constant between 18°C to 22°C and 35% to 68% humidity SOP4
2.7.3 All equipment used to transport sterile items are to be clean, dry and in good condition SOP4
2.7.4 There is a system in place for stock rotation and checking for sterile stock which is non-conforming SOP4
2.7.5 There is a system in place to record items released from sterile stock area which includes identification of item, cycle item has undergone, time of release and name of person authorising release SOP3
ADEQUATE (100%)
REQUIRES IMPROVEMENT (>70% = 4/5)
INADEQUATE (<70%)
2.7 OVERALL COMMENTS FOR THIS SECTION:
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3. EDUCATION3.1 100%ff undertaking oral health instrument reprocessing have undergone an annual performance appraisal process which includes- review of each staff members role description review of annual CHRISP workplace skills assessment review of each staff members training needs mandatory training (as per District policy) QH D&S ICG Section 1
3.2 70% of staff undertaking oral health instrument reprocessing have undertaken formal training (Certificate III) in Sterilization Practice QH D&S ICG Section 1
3.3 100% of new employees undertaking oral health instrument reprocessing (including casual and agency staff) have undertaken a formal orientation process including: preceptoring with a qualified staff member completion of workplace skills assessments provision of information regarding how to access the sterilizing
services instructions QH D&S ICG Section 1 & QH D&S ICG Section 4
3.4 100% of oral health staff undertake the Oral Health Easi-Sterilize Workplace Skills Assessment annually.
3.5 A formal Oral Health Sterilizing in-service program has been implemented, is undertaken annually, and is routinely evaluated QH D&S ICG Section 1 & QH D&S ICG Section 4
3.6 In-service is provided to all staff when new instrumentation or equipment is procured, prior to initial use QH D&S ICG Section 1 & QH D&S ICG Section 4
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3. EDUCATIONADEQUATE
(100%)REQUIRES IMPROVEMENT
(>70% = 5/6)INADEQUATE
(<70%)
3.1 OVERALL COMMENTS FOR THIS SECTION:
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4. MANAGEMENT4.1 There is a copy of AS 4187: 2003, AS 4815:2006 and associated relevant standards such as:
AS 1410- Pre vacuum Sterilizers
AS 1079- Packaging of items (sterile) for patient care
AS 1079.2 Part 2 Non-reusable papers- For wrapping of goods undergoing sterilization in HCF
AS 1079.4- Part 4- Flexible packaging systems – for single use in hospitals
AS 1079.5- Part 5: Non-reusable, non-woven wrapping materials- for goods undergoing sterilizing in HCF
AS 2182- Sterilizers- Steam-benchtop
AS 2192- Sterilizers-Steam-Downward displacement
AS 2437- Flushers/sanitisers for bed pans & urine bottles
AS 2478- Dry heat sterilizers
AS 2514- Drying cabinet for medical equipment
AS 2773.1- Ultrasonic cleaner-non portable
AS 2773.2- Ultrasonic cleaner- benchtop
AS 2774- Drying cabinet for respiratory apparatus
AS 2945- Batch-type washer/disinfector
AS 3789- Textiles for healthcare facilities and institutions
AS 3789.2- Part 2- Theatre linen and pre-packs
AS 3789.6- Part 6- fabric specifications
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AS 3789.8- Part 8 – recyclable barrier fabrics
AS3836- Rack conveyor type washers
AS4021- Non-reusable containers for the collection of sharp medical items used in health care areas
AS3816- Management of clinical and related wastes
AS4146- Laundry practice
AS4261- Reusable containers for the collection of sharp items used in human and animal medical applications
4.2 CHRISP Standard Operating Procedures are operationalised to meet the needs of the department
4.3 Standard Precautions and Workplace Health and Safety protocols are applied during all stages of the cleaning, disinfection and sterilizing process SOP1
4.4 Items designed to be reprocessed are processed to a level for their intended use eg cleaning followed by sterilization for all Semi-critical and critical items QH D&S ICG Section 1
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4. MANAGEMENT cont.4.5 Manufactures instructions are provided and available to staff for the processing of reusable medical devices QH D&S ICG Section 4 and Cleaning Complex instruments
4.6 Material Safety Data Sheets (MSDS) are available for all cleaning agents and chemicals which have been read and understood by staff prior to initial use SOP1 &QH D&S ICG Section 2
4.7 Labelling on cleaning agents are to comply with any statutory obligations and includes the following information: name of product name and addresses of manufacturer description & purpose of the product directions for dilution and use batch number expiry date advice not to mix cleaning agent with other chemicals safety & first aid instructions specific storage requirements SOP1 & Chem Alert
4.8 Chemicals used within the department are registered with the Therapeutic Goods Association QH D&S ICG Section 4 & QH D&S ICG Section 5
4.9 Manufacturers instructions are followed in relation to load content QH D&S ICG Section 3
4.10 Process in place for the notification of the manager or shift supervisor for all faults or failed processes (eg. cleaning cycles, sterilizing loads) SOP 3
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4. MANAGEMENT cont.4.11 The sterilizing processing facility has standard operating procedures for the following;
collection of used reusable items for areas outside the sterilizing processing facility e.g. ward, other facilities
cleaning items, equipment and the environment
inspection of cleaned items
assembly and disassembly of items
handling and processing of specialised items
packaging of items
loading of items for processing
sterilization cycle
process for linking sterilizer cycle batch information to items that have been sterilized to the patient
calibration, routine monitoring and recording of sterilizing equipment and cycles
unloading of sterilizers
storage of sterile items
validation of process for sterilizers
management of deviations and faults associated with processing of items
distribution of sterile items
recall of supplies or stored loads
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complaints procedure SOP1 to 5
4.12 Staffing profile is reviewed annually and meets the needs of the unit
4.13 Clear professional and operational reporting structure within the facility is evident
4.14 Incidents relating to the processing of reusable medical equipment are reported, risk rated and actioned within corporate and facility policy and the unit is provided with a summary of incidents regularly
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4. MANAGEMENT cont.ADEQUATE
(100%)REQUIRES IMPROVEMENT
(>70% = 10/14)INADEQUATE
(<70%)
4.1 OVERALL COMMENTS FOR THIS SECTION:
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5. CONSULTATION5.1 There is a formal communication process within Oral Health for the following: purchasing of instrumentation changes to configuration of instrument trays procedure scheduling development and implement an annual instrument stock take
procedure QH D&S ICG Section 4
5.2 There is a clearly defined relationship between Oral Health and other services within the District/facility, including but not limited to: infection control maintenance department patient safety officer peri-operative and surgical services Central Sterilizing Departments clinical procurement officer QH D&S ICG Section 4
5.3 There is a formal consultation process with the manager of the sterilizing facility for the purchase of all reusable medical devices QH D&S ICG Section 4
5.4 The design and workflow supports designated areas for cleaning, packaging, sterilizing and storage of sterile items Building & Refurbishment
5.5 Operation manuals for the sterilizers are readily available for maintenance and sterilizing staff to access QH D&S ICG Section 4
5.6 Each sterilizer and associated equipment has a preventative maintenance program (monthly, quarterly, annually) QH D&S ICG Section 4
5.7 Medical records departments are consulted about the management of sterilizing records that are to be archived QH D&S ICG Section 4
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5. CONSULTATIONADEQUATE
(100%)REQUIRES IMPROVEMENT
(>70%= 5/7)INADEQUATE
(<70%)
5.1 OVERALL COMMENTS FOR THIS SECTION:
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