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Wandsworth PCT
User guide to
the decontamination service from Synergy Healthcare
and
Compliance with Health Act 2006 and healthcare
commission standard Core standard C4c “All reusable
medical devices are properly decontaminated prior to use and
that the risks associated with Decontamination facilities and
processes are well managed”
for
Community Podiatry Service
Issued by Support Services Partnership South West London
Issue date: 01 July 2009
Issue no. 4
This user guide has been written for those who use the Synergy Healthcare
decontamination service on a day-to-day basis. It is for guidance only. You
should refer to your PCT’s policy on decontamination (in the policy section of
your PCT’s website).
Contents
1. Synergy Healthcare decontamination service .................................................... 3
2. Delivery and collection of instruments ................................................................ 3
3. What to do with clean instruments ..................................................................... 4
4. What do to with used instruments ...................................................................... 5
5. Barcode numbers .............................................................................................. 6
6. Tracking of instruments or sets of instruments ................................................... 6
7. Contents of instrument trays or sets .................................................................. 7
8. Podiatry domiciliary visits ................................................................................... 7
9. “Home” clinic for instruments ............................................................................. 8
10. Reporting problems ....................................................................................... 8
11. Protocol and liabilities for lost instruments ..................................................... 9
12. Making changes to the service..................................................................... 10
13. Buying new instruments ............................................................................... 10
14. Fast track service......................................................................................... 10
15. Supply of soft packs and disposable instruments ......................................... 10
16. Staff health and safety ................................................................................. 11
17. Synergy service hours ................................................................................. 11
18. Management and monitoring of Synergy contract ........................................ 11
19. Contact details ............................................................................................. 11
20. Amendments to this user guide.................................................................... 12
Appendix I. Delivery and collection schedule for your PCT ..................................... 13
Appendix II. Delivery note (sample) ....................................................................... 14
Appendix III. Sample label ...................................................................................... 15
Appendix IV. Service defect report form ................................................................. 16
Appendix V. Change control note ........................................................................... 17
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1. Synergy Healthcare decontamination service
1.1. Synergy Healthcare provides a decontamination service to the five south
west London PCTs from two sites. The service to Wandsworth PCT is
provided from Synergy’s Lewisham and Guildford sites. Synergy’s service
covers the PCT’s following clinical services:
Community Podiatry (Lewisham Branch)
Queen Mary’s Hospital Podiatry (Guildford Branch)
Queen Mary’s Hospital Roehampton (Guildford Branch)
1.2. Synergy’s decontamination service only covers reusable instruments.
1.3. Synergy’s service is compliant with and is accredited to the following
quality assurance standards:
EC 93/42 Medical Devices Directive Annex V
BS EN 46002/ISO13488
ISO 13485.
1.4. The contract with Synergy runs until 31 May 2011 and may be extended
to 31 May 2013.
2. Delivery and collection of instruments
2.1. Deliveries are made to an agreed delivery point on your site, according to
a defined schedule. The delivery schedule for your clinic is in appendix I.
2.2. Instruments and sets of instruments are delivered in a blue plastic box
with a green tamper proof tag. The usual size is 600 x 400 x 320
(although this may vary depending on the volume of instruments). The
Synergy driver tries to get the delivery signed for by a PCT representative.
There is a sample delivery note in appendix II.
2.3. Once the clean instruments have been removed from the delivery box, the
plastic liner should be placed inside the box. This box is now ready to be
the collection box for dirty instruments.
2.4. When the dirty instruments box is ready for collection, you should:
seal the box with the yellow tamper proof tag
turn the box label so it shows the Synergy Healthcare address
take the box to the collection point for your building or clinic area.
2.5. Synergy’s drivers do not accept dirty instruments in any other kind of box.
2.6. The boxes are collected by the Synergy driver according to an agreed
schedule (see appendix I). The instruments are normally returned on the
driver’s next delivery.
2.7. Ideally the dirty instruments box should not be left in a clinical area prior to
being sealed. In some cases this is unavoidable due to limited space.
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2.8. You should not leave the dirty instruments collection box in areas
accessible to the public. If this is unavoidable you should make sure the
box has been sealed with the yellow tamper proof tag.
2.9. Collection/ delivery boxes are all bar-coded and there is a charge if they
are lost.
2.10. If extra boxes are required, telephone Synergy who will bring them on the
next delivery.
3. What to do with clean instruments
Unpacking instruments
3.1. You should unpack clean instruments from the delivery box as soon as
possible (the delivery box then becomes the dirty instruments collection
box – see section 2). You should store the instruments in designated
storage cupboards. These storage cupboards meet infection control
requirements and instruments should not be stored elsewhere.
Before using instruments
3.2. Each reprocessed instrument or set has a label similar to the sample in
appendix III. Before using the instrument or set you must check the
following:
Is the process indicator (the word “steam”) purple-grey rather than
pink?
If there is tape on the package, does it show a stripe?
Is the packaging intact, undamaged and dry?
Is the package within its expiry date?
3.3. If the answer to any of the above questions is no, you must not use the
item. Place it in the dirty instruments box for Synergy to collect and
reprocess.
Instrument shelf life
3.4. Instruments which arrive from Synergy have a shelf life of 12 months from
the date of sterilisation, provided that storage meets the following
conditions:
stable temperature
dry well ventilated store
not stored near sinks or wash basins
out of direct sunlight
wrapping has not been punctured and seals are intact.
3.5. After one year they are no longer guaranteed sterile. It is therefore
important that your clinic has a system for ensuring that the most recently
delivered items are used last.
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3.6. If an instrument has exceeded its shelf life it must not be used and must
be placed in the dirty instruments box for Synergy to collect and
decontaminate.
3.7. To avoid this waste it is sensible to use the First In First Out storage
method (FIFO). When new stock arrives the current stock is moved to the
front of the storage shelf and the new stock is placed behind.
4. What to do with used instruments
Sets of instruments
4.1. Once a set of instruments has been used, you should replace the
instruments and the barcode tag in the tray, place the tray inside one of
the plastic pouches it came with, and place the pouch inside the brown
plastic liner in the dirty instruments collection box. Where possible, the
barcode for the instrument tray is glued to the tray itself rather than being
on a separate tag.
Individual or supplementary instruments
4.2. Once an individual instrument has been used, you should place it inside
one of the plastic pouches it came with, along with the barcode tag for that
instrument. If more than one supplementary instrument has been used for
a procedure you can place them all in the same plastic pouch as long as:
a) their barcode tags are all included, and
b) there were not two of the same type of instrument used during the
same procedure. If you used two of the same type of instrument then
you must place these two instruments in separate pouches with their
own barcode tags.
Instruments returned to Synergy
4.3. Any instrument or set which is returned from a clinic is regarded by
Synergy as contaminated and is put through the full decontamination
cycle, no matter what its immediate history.
Sharps and disposable instruments
4.4. All blades, needles and other dangerous items must be removed using a
blade remover and disposed of safely before equipment is collected by
Synergy. Synergy takes seriously any injury caused to a member of its
staff because of such items. If sharps or other such items are found,
Synergy issues an incident report to the clinic and copies it to your PCT’s
Risk Manager. Such an occurrence may be a breach of your PCT’s policy
and if so an incident form must be completed.
Loan sets
4.5. You may occasionally have a set of instruments on loan from another
PCT or from instrument manufacturers. In this case the loan set form
should be used. There is a pad of these forms in each clinic area.
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5. Barcode numbers
5.1. Each pack from Synergy carries two barcode numbers. One is the
product code, which stays with the instrument or set for its life. The other
is the serial number, which is unique to the reprocessing cycle. For single
instruments, the product code barcodes are on a separate barcode tag
which arrives with the instrument. For trays of instruments, the product
code barcodes are either glued to the instrument trays or are on a
separate tag.
5.2. It is important not to mix up or lose the barcode tags. They are necessary
to ensure that the instrument is returned to you, and for tracking
instruments to patients (see section 6). If an instrument arrives at
Synergy without a barcode tag, either there is a charge for replacing the
barcode tag, or the instrument is thrown away.
5.3. There are different barcode tag colours for each of the five PCTs in south
west London:
Croydon: orange
Kingston: red
Richmond & Twickenham: yellow
Sutton & Merton: blue
Wandsworth: green
5.4. You will easily be able to identify if you have received a set or
supplementary instrument by mistake that belongs to another PCT.
6. Tracking of instruments or sets of instruments
6.1. In this context tracking means being able to trace a particular instrument
or set of instruments back to the individual patient and procedure. (It does
not refer to tracking the location of the instruments in the building.)
Tracking of instruments to patients is part of the Healthcare Commission
requirements for decontamination.
6.2. There are two ways of recording instrument use on patients:
For paper notes:
Place one of the two peel-off sections of the barcode label (see
sample in appendix III) in the patient’s notes. This peel-off section
contains information about the set or instrument (product code) and
about the decontamination procedures it has gone through (serial
number). If you use more than one set or more than one instrument,
you must add the peel-off section for each set/ instrument to the
patient’s notes.
You should place the second peel-off section in the theatre record
book, where used.
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For electronic notes:
Enter only the serial number from the peel-off section of the barcode
label (see sample in appendix III) in the patient’s electronic record
(EPR). These numbers give sufficient information for Synergy to be
able to identify the set/ instrument and the decontamination
procedures it has undergone. If you use more than one set or more
than one instrument, you must enter the serial number for each set/
instrument in the patient’s electronic record.
At present there is no set space in the EPR for these numbers to be
entered so they should go in the Notes section. In future it is
anticipated there will be a designated field for these numbers. Take
care when entering the number to avoid making mistakes.
6.3. Either procedure a or procedure b above must be used for every patient
treatment episode.
Marking instruments or holders
6.4. Do not mark polypropylene equipment (bowls, jugs, kidney dishes, etc)
with permanent markers. The equipment becomes useless once the
marks start flaking off and there is a risk of wound contamination..
7. Contents of instrument trays or sets
7.1. Attached in appendix III is a list of the contents of the instrument sets or
trays which you use in your clinic. These lists are also laminated so they
can be displayed in the clinic. This makes it easier to identify if any
instruments are missing.
7.2. If you are using a complicated set of instruments (usually in a community
hospital) the set list may not be attached in the appendix. In this case the
set arrives from Synergy with a list of what it should contain.
7.3. On the label of each set or instrument is an exceptions box (see sample
label in appendix III). If a set has been authorised to be packed without
an instrument, this will be listed in the exceptions box and should not be
the subject of a service defect form.
8. Podiatry domiciliary visits
8.1. Podiatrists are supplied with boxes marked “clean” and “dirty” for making
home visits. One of the regulations governing the transportation of
category B infectious material is UN 3291. The boxes supplied for
domiciliary visits comply with this container specification. The boxes
come in two sizes. The smaller can hold about 5 standard podiatry sets
and the larger box can hold about 15 sets.
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8.2. All clean, sterile packages must be protected from the elements, therefore
it is essential that you carry sterile packs in the clean box to the place of
use.
8.3. Used instruments present a potential infectious risk and therefore, for the
safety of both patients and staff, you should place them immediately in the
dirty box. If this is not possible, you should place them in a leak proof
container (e.g. the plastic pouch they came in or a plastic bag) and
transfer them into the dirty box as soon as possible.
8.4. Lids of both clean and dirty boxes should remain closed at all times when
not is use.
8.5. Dirty boxes should be emptied into a collection box at a clinic as soon as
possible, although they can safely be kept sealed overnight.
8.6. Clean and dirty boxes do not need to be kept upright.
8.7. Both clean and dirty boxes should be sent to Synergy for cleaning once
every 3 – 6 months. Place them in the larger Synergy collection boxes.
They will be collected and returned by Synergy as part of their usual
round. The boxes are all bar-coded and Synergy returns them to their
“home” location.
9. “Home” clinic for instruments
9.1. Each instrument or set of instruments has a “home” clinic to which it is
returned, regardless of where it has been collected from. This means that
podiatrists doing home visits can return their instruments to any clinic in
their PCT.
9.2. If you want to change the home clinic for any reason (e.g. you want to
reduce or increase the number of instruments held at a given clinic, or you
want to close or move the clinic) this can be easily arranged – see section
12 on service changes.
10. Reporting problems
Problems with instruments
10.1. Despite your and Synergy’s best efforts, problems will sometimes occur.
The two mostly likely problems needing reporting are:
incomplete sets or lost instruments
instruments needing sharpening, repair or replacement
10.2. In both cases you should use the service defect report form (there is a
sample in appendix IV). There is a pad of these forms in each clinic area.
10.3. Please do not report problems which have already been identified in the
“exceptions” box on the label (see sample label in appendix III).
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10.4. Complete sections 1, 2 and 3 of the form. You must give the serial
number for the item in question, or else the problem cannot be
investigated. You can attach one of the peel-off labels onto the form but
you must also write the serial number on the form (or it will not appear on
the second and third copy of the form).
10.5. In the case of instruments needing repair or sharpening, it will help
Synergy to identify the instrument if you attach a red repair tag to it.
These tags are supplied by Synergy to every clinic. These tags are
additional to the service defect report form – they do not replace the form.
10.6. Return the top two copies of the form to Synergy with the problem set.
Attach the form to the set of instruments if possible (e.g. with a rubber
band), but do not put it inside the pouch with the dirty instruments.
10.7. If you want a speedy response you should ring Synergy about the
problem and follow this up by faxing the form to Synergy (see contact
details for fax number).
10.8. If the problem could give rise to potential risks to patients or staff then you
should also complete an Accident and Incident (AIR) form and return it to
your PCT’s Risk Department.
10.9. Synergy will organise the sharpening or repair of the instrument(s) you
have identified. Synergy has a repair contract with a surgical instrument
supplier. Where warranties require that only authorised person(s) are to
be used, please indicate this when reporting the defect. Synergy keeps
the set of instruments on its site until the instrument is returned. The cost
of the sharpening or repairs is included in Synergy’s monthly invoice to
your PCT.
10.10. Synergy uses a similar service defect report form to report any problems
back to a clinic, such as missing instruments or sharps being left in an
instrument tray.
10.11. Monthly statistics are generated by Synergy from these forms. The forms
are signed off by the SSP’s contract manager (see section x). They are
also reviewed regularly by the Service Review Committee (see section
18).
Service problems
10.12. You should report service problems such as persistently late deliveries to
Synergy using the same procedure as for problems with instruments. Put
the top two copies of the form into the collection box.
11. Protocol and liabilities for lost instruments
11.1. Instruments may be lost by the PCT or by Synergy. There are two points
at which missing instruments may be noticed:
by the clinician at the point of use. In this case it is Synergy’s
responsibility to replace the missing instrument(s).
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by Synergy after the first wash cycle. In this case it is the PCT’s
responsibility to replace the missing instrument(s).
11.2 Instruments found by Synergy that cannot be identified on their
equipment tracking system (e.g. an instrument which arrives without a
barcode tag) will be placed on an unidentified stock list and
communicated to the PCT. In the event that instruments are not identified
they will be held for 6 months and then disposed of.
12. Making changes to the service
12.1. You can suggest changes to the service at any time – changes to delivery
schedules or delivery points, changes to tray contents, adding new or
different types of instruments, etc.
12.2. You should complete part A of the change control note (see appendix V)
and send the form to your service lead. Your service lead will decide
whether to authorise the service change and, if so, will forward the form to
Synergy. Each change will have financial implications. In most cases
changes can be made easily and quickly.
13. Buying new instruments
13.1. Before you buy any new instruments it is advisable to send the
manufacturer’s reprocessing instructions to Synergy. Synergy processes
instruments in accordance with the Department of Health Hospital
Technical Memorandum HTM 01 01 Parts A and B, which means that
instruments must be compatible with:
pressure/ vacuum sterilisation at 134 C – 137 C
mechanical disinfection at 93 C.
13.2. Adding new instruments to standard trays, or adding new individual
instruments, needs to be managed through a change control note (see
section 12).
14. Fast track service
14.1. It is possible to have a fast track service whereby instruments are
returned within 24 hours or less, instead of the normal 48 hours. This
service is expensive. You should only need to use this service very
rarely, as more than enough instruments have been purchased for a
standard 48 hour turnaround. Use of the fast track service will be
identified and discussed at the Service Review Committee meetings (see
section 18 on contract management) with a view to reducing it.
15. Supply of soft packs and disposable instruments
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15.1. Your PCT may have arrangements with Synergy for them to supply you
with soft packs and/or disposable instruments. This provision is being
managed outside the standard decontamination service. You will be
informed of the ordering process for these items separately.
16. Staff health and safety
16.1. If you are treating a known infectious patient, please telephone Synergy
for advice (see section 19 for contact details) on how (or if) to transport
instruments safely to them. In certain circumstances you may need to
destroy the equipment rather than reprocess it.
17. Synergy service hours
17.1. Synergy’s sterile services units operate during the following hours:
07.00 Monday to 00.00 Friday
08.00 - 15.00 Saturday
08.00 - 13.00 Sunday
17.2. Synergy operates a Sunday service during public holidays.
18. Management and monitoring of Synergy contract
18.1. The SSP manages the contract on behalf of the five PCTs. If you have
any concerns about the service you should contact the SSP contract
manager (contact details are in section 19).
18.2. The service will be evaluated over the first few months of the contract (to
end July 2008) and changes may be made as a result. During this period
there will be no penalty charges for lost barcode tags, etc.
Service Review Committee
18.3. A Service Review Committee (SRC) meets quarterly. It has
representation from each of the five PCTs and from each of the services
which receives the decontamination service from Synergy. If you have
suggestions for changing or improving the service, your SRC
representative would be pleased to hear from you. The SSP’s contract
manager can tell you how to contact your SRC representative.
Customer satisfaction
18.4. Synergy circulates a 6 monthly survey form in order to assess overall
satisfaction with the service being provided.
19. Contact details
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19.1. You should contact Synergy for day-to-day operational issues such as
missing instruments. You should contact the SSP contract manager for
contractual issues such as changes to the service.
Synergy Healthcare
19.2.
Phil Harding
Deputy General Manager
Oakwood Close
Off Birdwood Avenue
Hither Green
Lewisham SE13 6RJ
Telephone: 020 8695 5599
Fax: 020 8695 6632
Email: philip.harding@synergyhealthplc.com
19.3. SSP contract manager
Pete Black
Estates & Facilities Contracting Manager
Support Services Partnership South West London
The Wilson
Mitcham
Surrey, CR4 4TP
Telephone: 020 8687 4631
Fax: 020 8687 7098
Mobile: 07810 541706
peter.black@swlondonssp.nhs.uk
20. Amendments to this user guide
20.1. For any corrections, amendments or updates to this user guide please
contact the SSP contract manager.
Appendices
I. Delivery and collection schedule
II. Delivery note – sample
III. Sample label
IV. Service defect report form
V. Change control note
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Appendix I. Delivery and collection schedule for your
PCT
Monday Tuesday Wednesday Thursday Friday
WANDSWORTH
PCT
Stormont HC 09:40 -10:00 09:40 -10:00 09:40 -10:00
St Christopher's HC 10:00 -10:20 10:00 -10:20 10:00 -10:20
Doddington 10:30 - 10:50 10:30 - 10:50 10:30 - 10:50
Bridge lane HC 11:10 - 11:30 11:10 - 11:30 11:10 - 11:30
Eileen Lecky Clinic 11:50 - 12:10 11:50 - 12:12 11:50 - 12:10
Queen Mary's
12:30 - 12:50 12:30 - 12:50 12:20 - 12:50
Hospital
Tudor Lodge HC 13:10 - 13:30 13:10 - 13:30 13:10 - 13:30
Brocklebank HC 13:50 - 14:10 13:50 - 14:10 13:50 - 14:10
St Johns Therapy 14:30 - 14:50 14:30 - 14:50 14:30 - 14:50
Centre
Tooting HC 15:10 - 15:30 15:10 - 15:30 15:10 - 15:30
Balham HC 15:50 - 16:10 15:50 - 16:10 15:50 - 16:10
Applicable to this user Guide
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Appendix II. Delivery note (sample)
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Appendix III. Sample label
Process indicator: the word STEAM goes purple-grey when it
has been successfully sterilised
Pack name (and code)
Exceptions list: anything exceptional
about this pack which you have agreed
with Synergy – this is rarely used
Peel-off sections (2)
Manuf = date of processing
Expiry = expiry date of pack
Product code: the permanent number for the
instrument/set
Serial number: this changes with every
reprocessing cycle
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Appendix IV. Service defect report form
SYNERGY SSD SERVICE REPORT
Pad No: Reference:
Originator please complete sections 1,2,3 & issue to Synergy Unit
Date: / /
1 Origination of Report PLEASE PRINT CLEARLY
Reporting Theatre
Department: Hospital: Ward or Clinic T,W,C
Name of
Reporter: Position
Severity Score
SSD to Trust: Destination Department: (1 - 4)
2 Classification of Defect (Tick below) (See Note Below)
Missing Instrument Damaged Wraps Incorrect Assembly
Extra Item on Tray Dirty Item Incorr. Packing Spec
Wrong Item on Tray Wet Pack/Tray Incorrect Labelling
DAMAGED ITEM WORN ITEM Late Supply Other
3. Details of Product (essential for tracing) Affix pack label if available
Tray/Pack Name Full Set No. Serial No (from Tray List)
Other Relevant Details
General Fault Estimate of Number affected:
4. Actions by Recipient Dept. (To be entered on TrakStar within 5 working days)
Immediate Action: Date Received
In Dept: / /
Name: Signature:
Long Term Action (Preventative)
Name: Signature:
5. Reviewed (Trust and Synergy)
Signed for Trust: Signed For Synergy:
6. Defect Responsibility (Tick Below)
Synergy Trust Joint Void
Within Synergy: Check / Wash / Inspect / Check & Pack / Sterilise / Delivery
7. Repair Service Instrument Description
Return to Theatres with Decontamination Report TICK FAO
for Attention of NAME
or Send for Repair via local agreement
Severity Score
1 = Minor Fault , little or no patient risk 2 = Moderate Fault , small patient risk
3 = Operation postponed , small patient risk 4 = Major Fault, operation postponed actual patient risk
Distribution: Top Copy to Target Department Second Copy to Originating Department
Third Copy to File
Chap 12 Doc 5.220 18/02/2005 Rev 5
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Appendix V. Change control note
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