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

LINKS TO PRINTABLE DOCUMENT AND IMAGES OF ORIGINAL WORK AND CERTIFICATION:

Original text document can be opened in a print-friendly format here
A document displaying RCHT’s weight-related manual handling guidelines [Evidence 2A] can be seen here
A document that shows how to log Internal/External Non-Conformances & Traylist Amendments [Evidence 2B, 2C, 2D] can be seen here
Images relating to the use of RCHT’s Incident Reporting System [Evidence 2E] can be seen 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 Two: page one; page two.
An image of the Assessment Plan relating to Units Two and Three can be seen here
Images of the Assessment Reports pertaining to Units Two and Three can be seen here: page one; page two; page three; page four.
Images of the Witness Testimony pertaining to Units Two and Three can be seen here: page one; page two.
Images of the original work submitted for Unit Two can be seen here: page one; page two; page three; page four; page five.
Images of the supporting Evidence submitted for Unit One: Evidence 2A; Evidence 2B – page one, page two, page three; Evidence 2C; Evidence 2D – page one, page two, page three, page four; Evidence 2E.

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

UNIT TWO CONTENTS:

Sort items according to the cleaning and disinfection process.
Outline the types of hazardous items that may be found in returned items.
Explain the importance of checking returned items against tray checklists in accordance with organisational requirements.
Summarise the precautions needed when handling contaminated waste in relation to returned packs.
Remove and dispose of any waste in line with organisational requirements. Explain the potential consequences of not complying with organisational requirements in relation to disposal of waste.
Explain the reasons why DIN trays/containers must be matched to sets.
Describe how to maintain accurate and complete electronic records.
Describe why it is important to follow relevant legislation, policies and procedures in relation to sorting returned items.
Complete incident report documentation legibly with full details and report to the appropriate person.

Sort items according to the cleaning and disinfection process.

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Many different items are received in the SSD Wash Room. It is essential to sort items according to their wash methods: some difficult-to-clean cannulated items require an ultrasonic wash to ensure all contamination is thoroughly flushed out (for example, ‘Mr Finlay’s Goldfinger’ or Pretzelflex Retractors); certain items with exposed electrical components (for example, Stryker Shavers) must be manually handwashed as they cannot withstand processing through the industrial washers – the same goes for delicate items such as dental handpieces; and other sets are able to be processed in a straightforward, non-sonic wash (all the ‘basic’ sets – for example, Basic Hand Sets, General Basic Sets, General Breast Sets).

In the case of items such as Pretzelflex Retractors whereby special sonic action is required, the set will be placed in the benchtop ultrasonic before processing through the industrial washer. Form ‘B-17, Rev.2’ outlines the daily checks, maintenance, and operating instructions for the benchtop ultrasonic. Key operating points to follow when using the benchtop ultrasonic machine are: ensure the machine has a sufficient supply of Tri-Active 8 detergent; load instruments into the basket correctly before placing the basket in the wash tank (no instruments are placed directly in the bottom of the tank – instruments must sit in the basket); the basket slides sideways to lock in position in the wash tank, ensuring that the flush ports are positioned over the docking ports on the wash tank bed; close the lid, make certain that cycle P1 is selected and press start; and thirty minutes later the cycle will finish, the lid can be lifted and the instruments removed.

To facilitate efficient processing of items in the washroom, it is vital to further sort sets into the following categories: ophthalmic; basic sets; laparoscopic equipment; loan sets (which are often priority items), including Duchy sets; items from Oral Surgery/Orthodontics/ENT-OPD; sets from PAMW Maternity; St. Michaels OPD and Penzance OPD; items from RCHT wards (Endoscopy/Colposcopy/A.N.C/Emergency Gynae Unit/Dermatology); and sets and spares from outside customers – these are placed in the blue ‘procedures’ container. This categorisation of items ensures that sets can be processed according to their priority.

Outline the types of hazardous items that may be found in returned items.

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Hazardous items are occasionally returned with the above-mentioned sets. Examples include: sharp blades still attached to knife handles; half-full vials of anaesthetic fluid returned with dental cartridge syringes; and afterbirth mess left in sets from PAMW Maternity. Whenever hazardous items are spotted in the washroom, a Supervisor must be informed, and photographic evidence may be taken for proof. A DATIXWeb record must be completed, as outlined in detail in Unit One. The photographic proof can be used in the Divisional Manager-led investigation which follows the DATIXWeb reporting of all such incidents. Once these procedures have been followed in relation to the above-mentioned examples: the knife handle blade would be carefully removed and disposed of in the ‘sharps’ bin; the anaesthetic fluid would be thoroughly flushed down the sink with plenty of water; and the afterbirth mess would be placed in the orange waste disposal bag next to the sink, before being tied securely, taken outside, and placed in the yellow bin on the loading bay ready to be taken away for incineration.

As outlined in the SSD policy document ‘B-27, Rev.1’, in the case of an actual needle stick injury: the Supervisor must be informed, and will ring the Theatre/Clinic/Outside Customer concerned; a photo will be taken of the offending item; an Internal Non-Conformance must be completed on the Q-Pulse system; the traylist will be scanned through to the Packing Room with the Non-Conformance number written on it; a DATIXWeb form must be completed; and the offending item will be disposed of in the yellow ‘sharps’ bin. Once the affected staff member has thoroughly washed out his/her needle stick wound, s/he must go to the Accident and Emergency Department for further treatment.

Explain the importance of checking returned items against tray checklists in accordance with organisational requirements.

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It is crucial to check returned items against tray checklists when processing sets in the Wash Room. If an instrument has not been noted as missing in Theatre it could simply have been returned to the SSD in the Theatre ‘spares’, in which case it must be reunited with the set before despatch to Theatre so that the surgeon has the full complement of instruments to work with in future operations. In worse case scenarios, the instrument (a source of contamination) could have been left in the Theatre or even left in a patient.

‘SOP-30, Rev.4’ outlines the key processes associated with the SSD staff noting that an instrument is missing: an Internal Non-Conformance record should be logged on Q-Pulse, recording the member of the SSD staff who originally assembled the set, the Theatre staff member/s who signed the checklist, the Theatre details where the set was used, and the Patient Number involved in the operation; the Q-Pulse log number thus generated should be written on the checklist, and the checklist should be scanned and printed for the attention of the Supervisor in the Packing Room; if the instrument is not found following a search of any associated trays and the industrial washers, the most senior member of Theatre staff must be informed; the member of Theatre staff may authorise the issue of the set despite the instrument’s absence – otherwise, the set will be quarantined; if the SSD duty Supervisor or Production Controller decides to replace the missing instrument or to reissue the set despite the instrument’s absence, a note will be made on the Q-Pulse Non-Conformance record. Supervisors can alter the checklist and mark the instrument as missing by following the guidelines on ‘HESSDA-7, Rev.2’, specifying the reason for the item’s removal.

Summarise the precautions needed when handling contaminated waste in relation to returned packs.

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RCHT’s Decontamination Policy highlights the importance of wearing PPE when dealing with the spill of blood or bodily fluids, stating that eye/face protection must be worn in addition to gloves and an apron if there is any risk of splashing. The policy stresses that in instances where sharp material is involved in a spillage, forceps should be used to remove the hazardous article and it must be placed immediately in a ‘sharps’ bin. The spillage should then be dealt with as soon as possible by using paper towels to mop up the excess, placing the used towels in a clinical waste bag, and cleaning the affected area by applying detergent and warm water with a disposable cloth or a mop. Additionally, in line with the SSD’s Health and Safety Policy, it is the duty of all staff members to replace compromised PPE – for example, gloves will not offer adequate protection if they are riddled with holes.

Remove and dispose of any waste in line with organisational requirements. Explain the potential consequences of not complying with organisational requirements in relation to disposal of waste.

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The SSD’s Health and Safety Policy outlines requirements concerning waste disposal: clear plastic bags are used for recyclable materials, such as plastic Azo Wipe containers (these must be rinsed out prior to bagging); the yellow ‘sharps’ bin is used for the disposal of sharps; the orange lidded container is used for glass; and orange sacks are used for the disposal of clinical waste. RCHT’s Waste Management Policy gives guidance on the types of container appropriate for different kinds of waste, specifying that orange sacks are used for infectious and potentially-infectious waste whilst black sacks are solely for domestic waste, not clinical or recyclable materials.

It is important to dispose of waste in line with these organisational requirements in order to minimize the risk of injury to oneself and others – for example, placing afterbirth mess in a black sack would likely result in a serious incident whereby an unsuspecting bin man becomes exposed to highly contaminated clinical waste. Single-use instrumentation is disposed of in the yellow ‘sharps’ bin, and the instrument details are written on a wooden tongue depressor and sent through to the IAP area so that staff members therein can fill out a form to send to the relevant Outside Customer, reminding them that single-use items are not to be returned to the SSD. A record of all returned single-use items is also kept in the IAP area.

Explain the reasons why DIN trays/containers must be matched to sets.

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Incorrect instrumentation is occasionally returned in DIN trays/containers – for example, a container with a labelled description as ‘Dermatology Set Standard-01’ might actually contain a Dermatology Lead and Forceps. It is important that DIN trays and containers are matched to sets. This is achieved by checking that the correct checklist has been returned with the set- the checklist ID should match the barcode of the DIN tray/container- and then ensuring that all the items on the checklist are present in the DIN tray. In instances where an incorrect checklist has been returned with the set, an effort should be made to locate the correct checklist – a checklist mix-up usually occurs between similar sets (for example, the checklist for ‘Gynae Laparoscopic Set-05’ might be returned with ‘Gynae Laparoscopic Set-06’).

When it is not possible to locate the correct checklist, the procedure outlined in the SSD policy document ‘B-7, Rev.3’ should be followed: the checklist must be looked up on the HESSDA traceability system by clicking on ‘Image and Document Assist’, entering the name or ID number of the set, selecting the correct set and clicking ‘OK’, and finally clicking on the ‘Checklist’ option. If DIN trays are sent through the Washer with incorrect contents, the efficiency of processing in the IAP is reduced as staff members have to spend time solving the problem rather than inspecting and wrapping sets; in the unlikely event that the problem is not picked up on in the IAP, incorrectly-labelled sets will be sent to Theatre, causing further inefficiency in the sense that sets will be unwrapped (thus becoming unsterile and needing to be reprocessed) and not even used, since Theatre staff did not find therein the instruments they expected and needed.

Describe how to maintain accurate and complete electronic records.

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As described in Unit One [together with the diagram of ‘The Traceability Cycle’], accurate and complete electronic records for every item processed in the SSD is achieved by scanning all items into the HESSDA traceability software at every stage of the decontamination cycle. Information is available on the Department’s Q-Pulse system regarding the correct usage of the traceability system at each stage of the decontamination cycle.

With reference to the Wash Room, ‘HESSDA-3’ details the process for loading sets and instruments onto carriages: on the main Wash Area screen, click on the relevant carriage, scan your name, scan the item, and click ‘Close’ when you have finished loading – when the carriage screen is open the ‘Edit Quantity’ icon can be used to specify a quantity of non-traceable items (such as ‘spares’), and the ‘Remove Item’ icon can be used if an item is scanned erroneously.

‘HESSDA-4’ provides information on loading the tunnel washers (Washers One and Two) and the single-chamber washer (Washer Three): after clicking on the relevant Washer and scanning your name badge, click the ‘Add From Cart’ icon and choose the correct carriage from the list, click ‘OK’, and finally click ‘Finish Loading’ and confirm the action. Handwashed items are processed according to the instructions in ‘HESSDA-13’ – the ‘Manual Wash’ icon is clicked and your name badge is scanned, the handwashed items are scanned, and then the ‘Finish’ button is clicked and the action confirmed.

Detailed guidelines on how to employ the traceability system are given for each stage of the decontamination cycle, for example: how to unload the Washers in the IAP Area (HESSDA-5); how to return items back to the SSD when working in the stores/autoclaves area (HESSDA-9); and how to locate a set (HESSDA-11), how to non-conform items to an earlier stage in the decontamination cycle (HESSDA-5), and so on.

Describe why it is important to follow relevant legislation, policies and procedures in relation to sorting returned items.

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RCHT’s Manual Handling Information & Theory Booklet for Clinical Staff provides information that is relevant to sorting returned items in the Wash Room, namely to work with weights that you are comfortable with (see Evidence 2A for suggested weight guidelines for men and women). These guidelines are particularly relevant when lifting carriages onto trolleys and pushing fully-laden carriages to the industrial Washers – it is advisable to ask another member of staff for help if the weight involved in these tasks is in excess of your personal capability.

Several SSD policy documents give details on how to sort and process specific items, such as On Loan Equipment (B4, Rev.3), Laryngeal Masks (B-6, Rev.3), and Ophthalmic Sets and Spares (B-10, Rev.3, and B-11, Rev.3). On loan equipment is received in the Wash Room and is accompanied by a form stating where it is to be despatched to, the Consultant’s name, the date and time it is needed, and whether it is to be sterilized or decontaminated only after use. Staff members have to write relevant information (despatch location, Consultant’s name, date and time of use) on a wooden tongue depressor, and attach this to the set. The On Loan Form accompanying the set is then scanned into the IAP area and filed as a record, with any photographs or associated paperwork being passed into the IAP area via the transfer hatch. A similar process is undertaken with sets from Duchy Hospital – these sets have been loaned from RCHT Theatres, and the paperwork returned with the set must be stapled to a sheet that is completed by Wash Room staff members, recording the set name, set ID number, and the Theatre that the set was loaned from. This stapled paperwork is then filed in the black folder situated in the Wash Room and kept as proof that the SSD has processed the set.

Laryngeal masks must be cleaned in the sink first to remove visible contamination, before the unique code numbers on the side of the laryngeal masks are scanned onto carriage ‘Q’. Carriage ‘Q’ is then loaded into Washer Number 3. When processing ophthalmic sets in the Wash Room it is necessary to have a single-tier non-sonic carriage (onto which the empty trays/containers will be loaded) and a multi-tier non-sonic carriage (onto which the sets will be placed, once all hinged instruments have been opened); there is an additional process involved in the case of Alcon Phaco Handpiece Sets, since the handpiece must be flushed through with the water gun, Azo-wiped clean, and placed on a clean tray before being passed into the IAP area via the transfer hatch. It is important to place an appropriate theatre tag or labelled wooden tongue depressor in with ophthalmic spares, as well as ensuring that the spare instruments in the small plastic containers correspond to the label on the box. All ophthalmic equipment is very delicate and must be handled with care.

Complete incident report documentation legibly with full details and report to the appropriate person.

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The intricacies of the DATIXWeb incident reporting system have been outlined in Unit One and earlier in this Unit, as well as the importance of informing a Supervisor of all such incidences. Logging Internal Non-Conformances, External Non-Conformances, and Tray List Amendments on the Q-Pulse system was described in Unit One. Evidence 2B demonstrates two examples of how to log an External Non-Conformance; Evidence 2C highlights how to log an Internal Non-Conformance; Evidence 2D outlines how to log a Tray List Amendment; and Evidence 2E shows how the DATIXWeb incident reporting system can be used in the case of ‘sharps’ being returned in sets.

Copyright 2016-present date 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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