BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices: Unit Three

Original text document can be opened in a print-friendly format here
Image certifying Chris Larham’s attainment of the BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices can be seen here
Image certifying Chris Larham’s competence in all six modules of the BTEC Level 3 Certificate in the Decontamination of Reusable Medical Devices can be seen here
Images of the Assessment Checklist pertaining to Unit Three can be seen here: page one; page two; page three.
Images of Evidence 3A can be seen here: page one; page two; page three.
Images of the original work submitted for Unit Three can be seen here: page one; page two; page three; page four; page five; page six; page seven; page eight.

LEVEL 3 CERTIFICATE IN DECONTAMINATION OF REUSABLE MEDICAL DEVICES: UNIT THREE

UNIT THREE: CONTENTS

Explain the function of each piece of decontamination equipment when in use.
Summarise the checks that are carried out on the decontamination equipment in line with relevant legislation and guidance requirements.
Clarify the concentrations of detergents and other chemicals used in the wash area.
Evaluate the importance of working as a team and knowing when to refer to an appropriate person. Explain the process followed when discovering abnormal performance of Decontamination equipments.
Explain why it is important to ensure Personal Protective Equipment is maintained.
Check off instruments against checklist and take notice of any comments made by theatre staff.
Keep sets of items being processed together where possible.
Accurately and legibly record details in accordance with organisational procedures.
Describe the operating instructions for washer/disinfectors.
Dismantle items to be processed and use brush and jet sprays and ensure instrument is fully submerged.
Maintain permissible weight and reach limits in accordance with manual handling regulations.
Load items in the correct position in the baskets with maximum exposure to the process.
Identify and manually clean items requiring special attention and handle in accordance with manufacturers’ instructions.
State the time and temperature requirements to achieve decontamination and disinfection of all items processed in the washer/disinfectors.
Explain the procedure to follow with inadequately cleaned items.

Explain the function of each piece of decontamination equipment when in use.

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Two four-chamber Tunnel Washers (Washers One and Two) and one single-chamber Cabinet Washer (Washer Three) are the major pieces of decontamination equipment in the SSD Wash Room. The Tunnel Washers’ water tank capacity is 35 litres and the Cabinet Washer’s water tank capacity stands at 30 litres. Since there should be approximately 5mls of detergent per litre of water tank capacity, the detergent dosage is 175mls per Tunnel Washer cycle and 150mls per Cabinet Washer cycle. A detergent dosage in the range of 170-300mls is acceptable for the Tunnel Washers, whereas the dosing range for the Cabinet Washer is 135-295mls; this forms one of the major parameters determining whether a cycle is ‘passed’ or ‘failed’ when the carriage comes to be unloaded in the IAP Area. The other difference between the Tunnel Washers and the Cabinet Washer is the fact that no ultrasonic action occurs in the Cabinet Washer, regardless of the magnet alignment of the carriage loaded into the chamber; if a carriage with a magnet alignment of ‘A C T’ (i.e. an ultrasonic carriage) is loaded into the Tunnel Washer then ultrasonic action will occur during the cycle (see paragraph five for specifics regarding carriages’ magnet alignment). Otherwise, the same cycle applies to both the Tunnel Washers and the Cabinet Washer, and will be described in detail in the following paragraph – clearly, the entire cycle takes place in the same chamber in the Cabinet Washer.

In chamber one, carriages undergo a cold water Pre-Rinse for approximately three minutes with normal water at a temperature not exceeding 35 degrees Celsius. During this phase a major part of the soils is flushed away; if the water temperature exceeds 35 degrees Celsius, blood can coagulate, denature and bond to the instruments, becoming harder to remove. Following this Pre-Rinse phase, the detergent is added and carriages receive a four-minute Wash at 65 degrees Celsius; the major cleaning takes place during this process. A thirty-second Post-Rinse ensues, ensuring complete removal of soap suds, before the carriage moves into chamber two. If a non-sonic carriage (magnet alignment ‘A D T’) is being processed, no action is taken in the second chamber – the carriage simply sits there until chamber three is available. If an ultrasonic carriage is being processed, the carriage is lowered into the ultrasonic tank and ultrasonic action takes place. As described in the Department of Health’s CFPP 01-01 Part D:Washer-disinfectors, high frequency sound waves are generated within the water by transducer-induced vibration of the surface of the ultrasonic tank, converting electrical energy into vibrations of the required frequency and amplitude – these high frequency sound waves effect ‘cavitation’, the rapid formation and collapse of tiny bubbles within the water, which provides effective cleaning action, particularly on instruments that have deep interstices that may be contaminated with bodily tissues, such as drills, reamers and burrs. The ultrasonic phase of the wash cycle lasts approximately seven-and-a-half minutes, after which the carriage moves into chamber three. Thermal Disinfection takes place in chamber three – a one-and-a-half minute Clean Rinse using RO water (Reverse Osmosis – a water purification process that uses a semipermeable membrane to remove larger particles [the solute] from the water molecules [the solvent]) takes place, before the water is heated up to 90 degrees Celsius over a period of approximately five minutes (the carriage is washed while the temperature is being raised) and then the carriage is washed at 90 degrees Celsius for a minimum of two minutes in order to meet the criterion for disinfection. Following this Thermal Disinfection phase, the carriage moves into chamber four. This final chamber is the dedicated Drying zone; hot air (115 degrees Celsius) is blown into the chamber, and the carriages are dried for fifteen minutes. Completion of the Drying phase marks the end of the cycle, and carriages move forward into the IAP Area ready to be unloaded.

A further piece of specialist Washroom cleaning equipment is the Oscar Cleaning System, used specifically for cleaning instruments in the Cement Removing Sets. A PowerPoint presentation emailed to all staff by Tim Booth (SSD Training Manager) gives step-by-step instructions on its use: firstly, Oscar is plugged in; secondly, a new cleaning cell is inserted; Oscar is then turned on by pressing the green button (Oscar must be turned off before cleaning cell insertion/removal); a connected handpiece and lead is returned in the Cement Removing Set – the lead must now be removed from this handpiece and the white cable attached to Oscar should be plugged into the end of the handpiece, ensuring that the red dots on Oscar’s cable and the handpiece are correctly aligned; the first instrument from the Cement Removing Set that requires cleaning should be screwed into the handpiece; this instrument is then inserted into the cleaning cell until some resistance is encountered – it is important not to push down too far, as this can result in piercing the cell; Oscar’s orange light illuminates to signify that the instrument has been inserted correctly, accompanied by a ‘clucking’ noise as Oscar begins cleaning the item; and upon termination of the ‘clucking’ noise, the instrument is withdrawn and inspected. This cycle of instrument insertion-withdrawal continues until all contaminated instruments have been cleaned to an acceptable standard.

Summarise the checks that are carried out on the decontamination equipment in line with relevant legislation and guidance requirements.

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Certain Washer checks are necessary in order to remain compliant with the validation requirements set out in the above-mentioned CFPP 01-01 Part D: Washer-disinfectors. These maintenance and testing duties are outlined in the SSD policy document ‘SOP-5, Rev.5’. Chemical residue testing must be undertaken at least once a year by the dosing agent supplier; in addition to this, the Medical Physics Department must undertake a quarterly bacterial endotoxin test on the RO water. In accordance with ISO11737-1 by the Andersen Caledonia, surgical instruments must be sent for bio-burden testing to measure the total number of viable micro-organisms on the medical devices prior to final sterilization and before implantation or use. The Trust’s Engineers are duty-bound to validate the Washers on a weekly basis, recording the results in the relevant Washer logbook – if this weekly testing is not undertaken then ‘FORM-42’ must be completed by the test person. Weekly Washer tests carried out by the Engineers include: safety checks; water hardness checks; RO water conductivity tests; and performing weekly cleaning efficacy tests, using Browne’s Ninhydrin protein detection test. Quarterly tests (undertaken by the Engineers following the expiration of the Washer warranty period) include: safety checks; automatic control test; checking the calibration of Washer instruments; thermometric testing for thermal disinfection; and cleaning efficacy tests. In order to remain compliant with the standards set out in the Welsh Health Technical Memorandum 01-01 Decontamination of medical devices within acute services (superseding the previous Health Technical Memorandum 2030 document), the following annual checks are listed in ‘SOP-5, Rev.5’: all the quarterly tests undertaken by the Engineers mentioned above; drainage checks; doors and door interlocks testing; water vapour discharge test; aerosol discharge check; tests on load carriers and air quality; checking load dryness; and over-temperature cut-out testing.

Daily Washer checks are outlined in the SSD policy document ‘B-16, Rev.2’ and daily carriage checks are listed in ‘B-21, Rev.2’. ‘Form-18’ is used to record the daily Washer checks and the daily carriage checks; these checks can only be carried out by staff members who have received the training necessary to competently undertake these processes. Daily Washer checks include: ensuring there is an adequate supply of detergent, connecting new containers if necessary; cleaning the inserted sieve in the chamber, taking care that no trapped item gets into the aspiration port of the circulating pump (remove the service window, remove the inserted sieve and clean it in the sink, remove any parts or items that may have fallen into the wash chamber, replace the inserted sieve and then replace the service window); performing a visual check of the central couplings; performing a visual check for damage on the inspection door and seals; performing a visual check of the top and bottom of the wash arms for any damage or blockages; ensuring that the wash arms are free to rotate; and performing a Washer cleaning efficacy test, by putting a Browne’s Load Check Integrator in a holder and placing it on a laden carriage and sending the carriage through the Washer to check for residual soil – if residual red soil is discovered, a non-conformance must be raised, all the above-mentioned Washer checks must be repeated, and the Washer cleaning efficacy test must once again be performed.

As regards the daily carriage checks, these encompass: ensuring the banding is present on the carriages – if it is missing it must be replaced; checking the carriage magnets are not loose or missing and ensuring that the alignment of the magnets represent the type of carriage to be processed (the magnet alignment for an ultrasonic carriage is ‘A C T’, non-ultrasonic carriages are ‘A D T’, and carriage ‘Q’ [‘Spikey’ – used for vitalograph tubings and LMAs] is ‘A E T/A T/B E T’); checking the wash arms are free to rotate and free from blockages; making certain that cart wheels are free to rotate, stable and not damaged; and checking that cart wheel brakes are working.

Clarify the concentrations of detergents and other chemicals used in the wash area.

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Several chemicals are used in the Wash Room. Actichlor (a chlorine disinfectant) is used for surface disinfection of blood spills – one tablet is placed in the Actichlor bottle and diluted with 1000ml of cold water. Surgistain is an efficient revitalizing solution that removes rust, pitting, stains and corrosions from stainless steel surgical instruments – one part Surgistain is mixed with seven parts hot water in a non-porous container. Surgislip is a non-sticky, non-toxic, silicone-free and water-soluble mineral oil lubricant that can withstand the high temperatures of autoclaving without becoming gummy. It forms a protective barrier on surgical instruments, preventing rusting, staining, and spotting while restoring articulation to sticky box-locks and joints and is diluted in the ratio of one part Surgislip to ten parts warm water. Process pH Plus is an aluminium-safe, lightly-fragranced alkaline sink detergent designed to ease the manual removal process. In line with the SSD policy document ‘B-1, Rev.3’, the sink must be filled with warm water in the temperature range 20-35 degrees Celsius up to either the lower line (20 litres) or the higher line (40 litres); 30mls of Process pH Plus is required for the twenty litre line, and 60mls of Process pH Plus is needed for the forty litre line. Sani-Cloth 70s are disinfectant wipes saturated with a 70% solution of Isopropyl Alcohol, used to pre-clean or decontaminate Medical Devices prior to sterilisation.

Evaluate the importance of working as a team and knowing when to refer to an appropriate person. Explain the process followed when discovering abnormal performance of Decontamination equipment.

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In order to efficiently process the high volume of work returned to the Wash Room it is important to work as a team. Many fully-laden buggies are received in the Wash Room throughout each shift and it is unfair to expect one person to empty and clean all of them singlehandedly; this would lead to an unacceptable level of fatigue and increase that staff member’s susceptibility to injury owing to the constant lifting and bending involved. It is common practice for various staff members to share buggy-emptying and -cleaning duties.

Once the work has been unloaded and separated according to the categories described in Unit Two, it is best to assign specific sets to different members of staff: one person will be in charge of ophthalmic sets and spares; another member of staff will process the basic sets; handwash duty and processing items from Colposcopy/A.N.C/Emergency Gynae Unit/Endoscopy will be assigned to another member of staff; and so on. Working in this way reduces the chance of priority items being overlooked.

If a large quantity of high-priority loan sets needs to be fast-tracked, it is most efficient if two staff members share the workload – in this way the loan sets can be loaded into the industrial Washers in succession, decreasing the chance of these sets being overlooked in the IAP Area as they will be unloaded onto the same trolley therein. The most important aspect of Wash Room teamwork is in relation to loading the industrial Washers – one person should be placed in charge of loading the Washers following the process described in Unit Two, in order to minimize the risk of carriages being loaded in an incorrect sequence on the HESSDA traceability system.

All issues that arise during a shift (for example, the detergent running out, a huge volume of work necessitating further assistance from other departments in the SSD for completion, the Washers being loaded incorrectly, abnormal functioning of the decontamination equipment etc) must be reported to a Supervisor who will take appropriate action. In the latter case, a Supervisor will attempt to rectify malfunctioning decontamination equipment; if the problem is complex and requires expert knowledge to correct, the Supervisor will inform an Engineer. Three members of the Estates & Facilities Department provide day-to-day engineering assistance to the SSD between the hours of 0800-1600. As outlined in RCHT’s Planned and Reactive Maintenance Policy, if an urgent issue arises outside of these hours, the Supervisor must telephone the Estates & Facilities Department’s Call Centre in order to receive on-call engineering assistance; a priority system and job log identification is provided for each request, with response times and priorities recorded. Less pressing requests can be logged using the electronic ‘PLANET’ system.

Explain why it is important to ensure Personal Protective Equipment is maintained.

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In line with the SSD policy document ‘B-28, Rev.1’, staff should ensure that there is an adequate supply of PPE (blue nitrile ‘inner’ gloves, surgical hats, water-repellent aprons, glasses, full-face visors and blue PVC ‘outer’ gloves), clinical waste bags, detergent, cloths, and other stock items for the remainder of the shift. If this check is not undertaken (for example, at the beginning of a 2-10pm shift), certain members of staff (for example, staff who work a 4pm-10pm or a 6pm-10pm shift) may not have a supply of PPE when their shift commences. It is important that all the members of Wash Room staff wear the PPE provided in order to protect against the risk of direct contact with bodily-fluid-contaminated equipment. If any PPE becomes compromised (for example, holes in gloves/aprons) it must be discarded and replaced immediately.

Check off instruments against checklist and take notice of any comments made by theatre staff.

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The importance of checking off instruments against the associated checklist is explained in Unit Two, and the details of logging any comments made by Theatre staff are outlined in Unit One.

Keep sets of items being processed together where possible.

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Certain sets need to be separated into two DIN containers, owing either to the number of instruments therein (for example, Cardiovascular Sets/Vaginal Hysterectomy Sets) or the fact that certain instruments in a set must be manually washed whereas the rest must be processed through the industrial Washer (for example, Halo Sets). Whenever a set is split into two DIN containers a labelled wooden tongue depressor (detailing the set name, set’s seven-digit number, and set’s destination) must be attached to the non-barcoded container so that they can be matched up after being unloaded in the IAP Area. Both DIN containers for the Cardiovascular/Vaginal Hysterectomy Sets should be placed next to each other on the carriage to further minimize the risk of confusion during the unloading process in the IAP Area.

Accurately and legibly record details in accordance with organisational procedures.

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The need to accurately and legibly record details in accordance with organisational procedures has been explained in relation to the processing of loan sets (including Duchy sets), and also in terms of scanning the set’s barcode rather than the checklist when loading a carriage, in Unit Two.

Describe the operating instructions for washer/disinfectors.

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Operating instructions for the loading of Washers in terms of correct recording on the HESSDA traceability system are detailed in Unit Two; the SSD policy document ‘B-18, Rev.2’ makes it clear that heavier sets should be placed on the bottom of the carriage, and carriages should not be overloaded as the wash arms will not rotate correctly.

Dismantle items to be processed and use brush and jet sprays and ensure instrument is fully submerged.

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A simple example of an item that must be dismantled before processing through the Washer is a ‘Johans Forceps’. The Johans Forceps must be carefully removed from its black outer sheath, and any heavy soiling should be removed by washing it in the sink, using a soft brush to avoid damaging the instrument. The outer sheath must be flushed through with the water jet, as is the case with all cannulated items as outlined in the SSD policy document ‘B-1, Rev.3’; in this example, the black outer sheath is too delicate to withstand the insertion of flexistem, but the majority of cannulated items (such as Stryker Pin Collets/Striker Wire Collets/Suction Nozzles/Reamers/Cholangeogram Forceps and so on) must undergo flexistem ‘flushing’ prior to use of the water gun. All instruments must be submerged while scrubbing/flushing takes place in order to minimize the risk of splashing oneself or other SSD staff members.

Maintain permissible weight and reach limits in accordance with manual handling regulations.

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When loading washed items onto a carriage, it is best practice to load heavy sets onto the lower shelves (in order to minimize muscle strain and remain within the manual handling guidelines outlined in Unit Two, Evidence 2A) and to ensure a sensible weight distribution between the left- and right-hand side of a carriage, thus preventing the carriage from sliding/tipping in the industrial Washer.

Load items in the correct position in baskets with maximum exposure to the process.

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The SSD policy document ‘SOP-4’ outlines the correct manner in which to load instruments and hollowware: instrument jaws should be fully opened in order to ensure maximum exposure to the wash process and facilitate effective washing; jugs and bowls should be placed upside down in a suitably deep DIN basket to keep the items from moving or turning over; and precautions must be taken to avoid items becoming entangled in the spray arms (Breast Pump Tubing should be placed in a small, lidded DIN basket, and Diathermy Leads should be placed beneath the instruments in an ‘Ortho Basic Set’, for example).

Instruments that benefit from an ultrasonic wash (for example, Vaginal Speculums/C Nail Sets) should be placed on a red ultrasonic carriage (Carriages ‘O’ and ‘I’); items that either cannot withstand- or do not require- ultrasonic processing (such as telescopes/plastic containers/basic sets) are placed on a blue, non-sonic carriage. Instruments which require additional support to remain fully exposed to the wash cycle (such as Laryngeal Mask Airways/Quivers) are placed on carriage ‘Q’; this carriage receives decontamination with no ultrasonic action or rinse aid, and must be loaded into Washer Three.

Identify and manually clean items requiring special attention and handle in accordance with manufacturers’ instructions.

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Certain items require manual cleaning rather than processing through the industrial Washers, as they are either too delicate to withstand the industrial wash cycle or they contain exposed electrical components that will be damaged by a fifty-minute wash. Examples of items requiring a manual wash are: Dental Handpieces; Formula Stryker Shavers; Harmonic Handpieces; Halo Sets (as mentioned above); Bard Magnum Biopsy Guns; and Lead Hands. When these items are unloaded from the Theatre buggies they are placed on a trolley for the attention of whomever has been allocated the manual washing task; this ensures that these sets do not get buried amongst the ‘basic’ sets, and gives the designated manual wash staff member a clearer picture of that specific workload – this ensures that the manual wash process is started early enough to finish the task before shift completion.

The process for manual cleaning is as follows: firstly, the sink and surrounding splashboards are thoroughly washed using Actichlor and a blue cloth, and dried using sheets of Kleenex roll; the sink is filled to either the twenty- or forty-litre line (depending on the workload) with water in the 20-35 degrees Celsius temperature range, and the appropriate amount of Process pH Plus is added; the draining area of the sink is then covered in Kleenex roll, providing a drying area for instruments post-wash; a trolley designated for post-manually-washed items will be prepared by wiping down the surfaces using Sani-Cloth 70s – any DIN baskets needed for transporting Dental Handpieces/Lead Hands/Formula Stryker Shavers will likewise be cleaned, together with the relevant Theatre tags (Trauma/Oral/Oral P.D.S./Orthodontics/St. Michaels/Penzance); all items are then scanned into the ‘Manual Wash’ function of the HESSDA traceability system, before being immersed in the water, taking care not to immerse exposed electrical components – dental handpieces are the exception to this immersion, as they are simply cleaned with a sink-water-and-detergent-laden blue cloth before being rinsed with clean water and placed on the Kleenex roll; after a period of soaking designed to loosen any contamination, the items are cleaned with soft brushes, flexistem, the jet spray, and a blue cloth as appropriate, before being rinsed off with clean water and placed to dry on the Kleenex roll-covered draining area – as stated in RCHT’s Decontamination Policy, the water and detergent must be changed if it becomes obviously soiled or contaminated during the manual wash process; more Kleenex roll is used to dry any items that have not dried naturally once all the instruments have been manually washed; the items are wiped with Sani-Cloth 70s and placed in the DIN baskets on the aforementioned post-manual wash trolley; once all the manual wash items have been processed they are then passed into the IAP Area via the transfer hatch and the process is completed on the HESSDA traceability system by clicking on ‘Finish’ and confirming the action in line with the SSD policy document ‘HESSDA-13, Rev.3’. Prior to using Sani-Cloth 70s to clean the Dental Handpieces, the tapered end of the handpiece should be placed in a Kavo Cleanpac pouch and the working end of the handpiece should be sprayed with Kavo spray in line with the SSD policy document ‘B-13, Rev.2’, stopping when the spray comes out of the end of the handpiece; Kavo spray helps to ensure a long life for the handpieces, as well as flushing out anything that might have been missed during the manual wash process. Photographic evidence for the manual wash procedure is given in Evidence 3A [available to view at the end of the document mentioned in the first link at the top of this webpage].

Telescopes are another set of items that require special care and attention when processing in the Wash Room, since any damage caused by incorrect handling is an expensive mistake – telescopes cost upwards of three thousand pounds each. The SSD policy document ‘B-12, Rev.3’ outlines the following process for dealing with telescopes: the telescope is first placed on the draining board, ready to process, and any protective sheath is removed; both hands must be used to remove a telescope from its own tray, supporting both the eyepiece and the distal end – the telescope must be handled with great care at all times, holding it by the eyepiece when gently removing soil with a cloth and warm water; the outer light connector should be disconnected, the inner sleeve loosened, and the light connector loosely re-connected prior to replacing the telescope in its tray – if the scope has its own metal cage, the lid is replaced on top, otherwise the lid must be placed underneath its case; if the telescope case sits loosely on the carriage it should be placed in an empty DIN container; and the telescope must be scanned onto a non-sonic carriage.

State the time and temperature requirements to achieve decontamination and disinfection of all items processed in the washer/disinfectors.

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An A0=600 value is stipulated as the minimum requirement (where ‘A0’ is a physical parameter denoting the inactivation of microorganisms) for the disinfection cycle of the Washer-Disinfectors in EN ISO 15883-1; this corresponds to 80 degrees Celsius for ten minutes/90 degrees Celsius for 1 minute/93 degrees Celsius for 30 seconds. As mentioned above, the Washer-Disinfectors in the SSD achieve a wash temperature in excess of 90 degrees Celsius for over two minutes, comfortably surpassing the minimum standard.

Explain the procedure to follow with inadequately cleaned items.

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Occasionally, items need to be non-conformed from the IAP Area to the Wash Room owing to inadequate cleaning. As outlined in the SSD policy document ‘HESSDA-6, Rev.3’, the following steps are performed to non-conform an item to an earlier stage in the Decontamination Cycle: the Non-Conform icon must be clicked; a reason for the non-conformance must be specified after clicking on the ‘Select Reason’ button; the return location should be selected from the dropdown box (after optionally entering a comment into the ‘Comment’ box); and if a particular instrument is the source of the non-conformance, ‘Show Contents’ must be clicked and the relevant instrument selected by ticking the appropriate box and clicking ‘OK’. An explanatory note will be returned with the set, specifying the reason for the non-conformance (for example, “Blood in grooves of Lanes Toothed Dissecting Forceps”). When such sets are returned to the Wash Room, the member of staff that re-processes the set will pay particular attention to cleaning the offending item, ensuring it is scrubbed clean in the sink prior to the set being scanned onto a carriage once again.

Copyright 2016-present day sharedsapience.info. Permission to use quotations from this BTEC Unit is granted subject to appropriate credit being given to Chris Larham and sharedsapience.info as authorial and website sources, respectively.

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34-year-old father of three wonderful children [William, Seth, and Alyssa]. Works as an Assistant Technical Officer in the Sterile Services Department of Treliske Hospital, Cornwall. Enjoys jogging, web design, being a bit of a geek, and supporting Arsenal FC. Obtained a BA degree in English from the University of Bolton in 2008, and has continued to gain qualifications in a diverse range of subjects thereafter.

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