Tracking and Tracing – What is the difference?

Do the terms “tracking”, “tracing”, “traceability” and “batch control identification” confuse you? You are not alone. Even the experts have trouble agreeing on what these terms mean. Because we use these terms in relation to reprocessing (sterilisation) of Reusable Medical Devices (RMD) in dentistry and medicine, it is very important that we have a clear idea about their purpose.

Where do the terms come from?
The terms tracking and tracing have logistical origins.
Tracking is a process where you know where any item is at any time.
Tracing is being able to tell the history of where an item has been.

Why does it matter?
1. In the event of a failure in your reprocessing system you need to know how to do a recall of instruments (tracking) or recall of patients who were exposed to those instrument (tracing).
2. In the event of a patient acquiring an infection only attributed to their healthcare experience/treatment (HAI) then it is important to be able to determine whether reprocessing of RMD (tracing) played a part in the HAI.
[3. Accreditation requires these processes are in place because they are important aspects of safety and quality systems.]

Why is the confusion with terms?

Dentists traditional are more familiar with the term “batch control number” or “batch control indentification (BCI)” (AS 4815:2006). Using BCI, RMD are linked to a sterilization cycle batch (tracking) and if the RMD are used, then traced to a patient.

In newer AS/NZS 4187:2014 and National Standards (used in accreditation) the term “Traceability” is used instead of “tracking and tracing” or Batch Control identification. This is because traceability is no longer just concerned to items going through a steriliser “batch“, but include any RMD’s reprocessed in high level chemical disinfection system. Batch Control Identification is just considered a version of “traceability”.

Unfortuately ADA Guidelines for Infection Control (Third Edition) 2015 says that traceability has no place in dental practice!

What!
Don’t misinterpret this statement.

The ADA guidelines make that statement about “traceability” ONLY because the ADA guidelines authors took a very specific view/interpretation of the meaning of  “traceability”.  In fact the ADA Guidelines fully supports the use of BCI, which is the form of traceability required by the standards for general dental practice.
The version of  ‘Traceability‘ which is considered unnecessary by the ADA in dentistry involves high levels of instrument identification and high levels of tracing history. e.g. being able to trace individual instruments (laser or otherwise uniquely identified) each time they are used on patients and then each time they are reprocessed. Imagine the pointless data bloat if we traced the history of patient use and sterilisation cycles for each identifiable individual instrument, over a compulsory 7 year period. e.g. 10 instruments in your cons kit X 3 sterilisations per day X 3 patients treatment X 5 days per wk X 52 wks per year X each 7 years = 163800 individual records for one cons kit.

How traceable does traceability need to be?

“As a minimum, the traceability system shall be sufficient to enable the identification of a patient(s) where a nonconforming product has been used in an event that a recall is necessary.” [AS/NZS 4187:2014]
Procedures need to be in place to detect a nonconforming product before they are used on a patient.

A. What needs to be traced when we reprocess a RMD?

AS 4815:2006 AS 4187:2014 ADA Guidelines RACGP Standards!
Patient R R R O
Steriliser Batch R R R O
Semi-critical# RMD  R^
Critical# RMD R R* R O
R – Required
O- Optional but recommended
* Individually identifiable RMD if implantable and reprocessed
^ If undergoing high level chemical disinfection
# Semi-critical RMD are those that come into contact with mucous membranes or non-intact skin.
# Critical RMD are those that come into contact with the vascular system or sterile tissue and that shall be sterile at the time of use. e.g. surgical instruments.
! RACGP Standards for General Practice July 2017 (medical drs)

B. Where is the Traceability information recorded?
The Traceability system forms part of the release and quality assurance management of RMD. The system of traceability could vary depending on whether an electronic system or paper system is used.

Where to start

Any healthcare organisation who packages instruments can set up an extremely simple system for traceability and quality control.
A. Sterilisation log
All practices are required to keep a sterilisation log book. This can be a paper book; a paper log that is scanned into a computer; or an electronic logging system. The record requirements are the same in each case (see table). Each sterilisation load has a separate sterilisation load (or batch) number. This load number must be unique especially if you have more than one steriliser.
B. Recording information on the packaging of RMD’s
By recording the sterilisation cycle + date we have a link back to all the respective data on the sterilisation log for that cycle. The date helps us use the oldest pack first and if necessary an expiry date. The packaging staff member initals the pack so if the pack instruments are incorrect or nonconforming (not clean) then we can consult; educate and correct this process. The external chemical indicator allows the end user (dental practitioner) to check themselves as to whether the instruments went through the steriliser. The stage of examining and opening the package is a “release” phase in reprocessing and would be the responsibility of the operater or assistant.
(Est time to do this. 2 second with a self inking date and cycle stamp – cost $110 for 1000’s of prints)
C. Patient records
The steriliser cycle number is added into the patients records which will already include a date. This cycle information allows us to find the patient should a future recall of instruments from that particular sterilisation cycle occurs.
Time to do this: 2 seconds.

Packages of RMD Steriliser Log Patient Record
Cycle Number Cycle Number (unique) Cycle Number
Date processed Date processed Date of use
Packing person Load and release person/s
Contents * if not obvious due to packaging Contents of load: RMD name or set and number
Chemical indicator Parameters printout
Functional tests e.g. Bowie Dick/Helix

Traceability can be simple or complex. You can trace each load or only critical instruments. The best, quickest and easiest system is one that is consistent for all instruments and staff at the practice.

References:
Guidelines for Infection Control 2015 Australian Dental Association
RACGP Standards for General Practice Jul 2017

dental equipment needs sterilising

 

 

Facts and Myths Infection Control

infection control myths and facts

Facts and Myths of infection control (heard or read in 2016)

  1. Via “tracking” you can demonstrate a patient hasn’t got an infection from your practice (controlling infection control!)
  2. An ultrasonic is needed even if you have a washer-disinfector.
  3. It’s quicker to ask the ADA than seek the answer yourself.
  4. No-one has ever got an infection from a dental practice.
  5. Ever Sterilisation cycle needs a PCD (Helix or Bowie Dick)
  6. An ICMP (infection control management plan) replaces your sterilisation manual.

Let’s look at the statements –
1. Tracking instruments
Tracking is required to keep dentists and their staff “on the ball”. Tracking tries to demonstrate that a particular pack of instruments has been through a particular steriliser cycle. BUT unless your tracking system takes a picture of the pack with the steriliser tape color changed you aren’t even really demonstrating the pack went through a cycle!
Most systems only tell you that you know the number of a cycle that has been completed.

However that doesn’t mean I disagree with tracking. We track all our instruments because I think it is good idea. However personally I would be cautious about investing a lot of money into a scanning tracker system at this stage because I think they will improve in the future. I imagine a time when the scanner picks up the changes in the packaging that occur with sterilisation rather than just reading a bar code that remains unchanged in the steriliser.

Of course sterilisation is a theoretical practice. When we sterilise we do so with an assurance that the possiblity instruments have one viable bacteria on them is one item in one million. However we know that if instruments are not cleaned properly then this figure is incorrect and people have been infected via instruments that have been through sterilisers (not dental instruments) at correct time, temperature and pressure.
If stats were taken literally:
21,000 dentists in Australia  X 48 sterilisation cycles = 1 million cycles
So does that mean that you never want to be the 49th patient a dentist sees because you are likely to have THE VIABLE micro-organism!
Nahhh… but it isn’t that simple.

Track all your instruments for convenience because simple systems are the quickest and the best.

2. Ultrasonic Cleaners
Ultrasonic cleaners were basically introduced for staff occupational health and safety (safe non-scrubbing). They are designed to reduce operator error in instrument cleaning. However in dentistry we all know that unless you remove composite and cements from instruments immediately chairside then an ultrasonic cleaner nor a washer-disinfector are not going to work.
Washer-disinfectors are used similarly to ultrasonics in dental practices so generally if you use one then you dont need the other. You should speak to other dentists who use washer-disinfectors or ultrasonics when you are looking to buy a new one. Some washer-disinfectors have an ultrasonic mechanism built in.

Testing ultrasonic cleaners each morning is for the benefit of the practice. It is of no use placing instruments into an ultrasonic cleaner that is not working!!!
Also remember that research has shown if you place instruments into dirty ultrasonic cleaning liquid they will be dirtier than when you put them in.

3. ADA versus Google
It’s always nice to speak to a person at the ADA but for many issues it is quicker googling and asking the source. Examples: Fair Work – look up the staff award and read it yourself. You are supposed to have an award accessible for the staff anyway; Long Service leave – this is a state based function and Victoria has a really helpful help line.
The ADA committee members have a wealth of knowledge but you need to allow time to get onto the correct person.
Other options of information:
Generally some of the facebook groups for dentistry are interesting for different opinions and you can often get a quick response as dentists play online. The ADA Inc site has helpful HR resources but check that they are current and applies to your own state.

Remember the ADA in Australia is a professional group of dentists and have no power to set “rules”. Even the ADA infection control guidelines can be seen as an “interpretation” of AS 4815 and the NHMRC guidelines. The Dental Board resources should be looked at first for clinical advice. The Oral Therapeutic Guidelines are also important for conventional requirements. The ADA has representatives on the Therapeutic Guidelines Committees and on Standards Australia committees.
For SmartDentist subscribers check out your “Clinical Guidelines” [Resources > Clinical Guidelines] first as this is a group of documents to help you make effective clinical decisions.

4. No-one has ever got an infection from a dental practice (other than the contriversial HIV dentist)
This is not correct. There have been documented cases of infection transfer.
The recent 4 cases of Infection control breaches in 4  NSW practices has had a review and they know 26 people from the practices have now newly discovered they have BBV.
http://www.health.nsw.gov.au/Infectious/reports/Documents/dental-investigation-report-2016.pdf
Check out this most recent review on dental transmission.
https://www.cdc.gov/oralhealth/infectioncontrol/pdf/pathogentransmission.pdf

5. Every sterilisation cycle needs a PCD
Helix or Bowie Dick devices are required at the start of each day for an empty steriliser. They aim to “challenge” a Process – hence the name Process Challenge Devices. The process they “challenge” is the ability of the steriliser to remove all air from the steriliser so it can fill up totally with steam. You can use a specific device made to test this in your normal cycles but these tend to be slightly different in nature. While this is heavily promoted by a particular supplier of these consumables (yes, they sell them) the evidence for their use has not been declared manditory by AS 4815.
The requirement by Australian Standards is to have the device used at the start of the day.

6. An ICMP (infection control management plan) replaces your sterilisation manual.
No your sterilisation policy manual is only part of the infection control management plan. The idea of a “management plan” is that you:

  1. Work out what you need to manage.e.g. what are your infection control risks? Name and sham each one of them. Use a Risk analysis tool to document the risks and have them in your risk register so you can review them at a later date.
  2. Document how you are managing these infection control risks. e.g. this is via your policies and procedures so this is where your infection control manual fits in. You cant just use the ADA guidelines as that document isn’t a procedure manual and says in some parts…”you can do this….or you can do that”.
  3. Plan staff training so everyone is part of implementing your plan

SmartDentist subscribers have an online Infection control management plan – easy!

ICMP for Dentists

Infection Control Management Plan Qld Dentists
Are you a dentist in Queensland?
Do you understand your practice is required to have an Infection Control Management Plan (ICMP)?

The DBA Meeting in March 2016 reports that the Chief Health Officer of Queensland’s Department of Health asked the Board to make practitioners aware of the requirement under the Public Health Act 2005 (Qld) for all dental practices (private and public) to have an Infection Control Management Plan.
Interestingly this has been a requirement since Dec 2006 but just recently the Health Department has decided to randomly audit dental practices.

SmartDentist makes the process of developing an ICMP easy. We have templated policies covering the 10 core elements of a ICMP. SmartDentist also has templated the core risk assessment  requirements and provides a simple means to provide online training and the timetabling and recording of training.
The solutions within SmartDentist provides the means for keeping your ICMP a ‘living’ part of your dental practice. Incident reporting and auditing, via Smartdentist, supplement the way the ICMP actually works within a practice.

The Qld Health Department doesn’t recognise the ‘introduction to Dental Practice Accreditation’ as evidence of compliance but the elements of an ICMP should be covered when practices complete accreditation against the NSQHS standards. Your dental practice accreditation should have included infection control policies covering the 10 Core Elements of an ICMP; Register of IC risks and Staff training.

View a completed Infection Control Management Plan
This youtube video demonstrates the ICMP within SmartDentist and how the process of bringing together the core aspects of your Infection Control Management Plan is made manageable with the solutions in SmartDentist.

Dental Practices can either chose a solution for their ICMP which repects the need for ongoing review and compliance with infection control or just worry about a temporary paper chase when the Health Department contacts them.
For help in creating a management solution or any aspect of your ICMP contact me directly glenda@smartdentist.com.au or join SmartDentist today.

PS. Check your own policies against these infection control elements.
The ten core elements in an ICMP are:

  1. Hand washing and hand hygiene
  2. Personal protective equipment
  3. Management of blood/body fluid exposures
  4. Infection control and employee health
  5. Immunisation
  6. Environmental hygiene
  7. Pre-treatment assessment of infection control risk
  8. Non-reuse of single-use medical devices and reprocessing of reusable medical devices
  9. Delegation of responsibility for infection control
  10. Process for the investigation of infection control incidents

practice validation and the ADA

Have you read the ADA News Bulletin Aug 2016- Practice Validation and infection control
Glazed eyes? Confused? Yes infection control is an unromantic topic.
Here is my attempt in trying to explain what the author might have meant by “Practice validation and infection control” –

In your dental practice you need to consider what you do about infection control because it has to be:

  1. as required by law
  2. written down (computer is ok)
  3. what staff actually do

Your procedures must include the collection and saving (storing) of some physical evidence that staff have actually done what they are supposed to do in particular areas of procedures.

The topics you need to cover with written procedures may best be sourced from the list in “The ADA guidelines for infection control”. The ADA Guidelines list was the basis for SmartDentist template procedures. You can use these as for your own procedure manual (e.g. Go to the template library and press +add. Then change as required)
The Accreditation standard 3, quoted in the article as a reference source for appropriate policies and procedures, does not ONLY cover infection control but includes preventing infections – hence the confusing inclusion of antimicrobial prescribing etc. (check out SmartDentist for policies and procedures in these additional accrediation areas)

The ADA News Bulletin article goes on with detailed information specific to the validation of autoclaves (moist heat sterilisers).
[I wonder if this is because I have recently seen sales info. that says you can buy a sterliser that comes supplied with a validation certificate! That is a big no no! (except if you are in a remote area)]

For practices that think they need to conform to AS/NZ 4187 be warned that the information in this article falls well short of the requirements for validation in AS/NZ 4187 but most of us will use AS4815 as discussed in the article.

It seems a bit odd for the ADA to state in writing (for others to quote later) that it is the dentist’s responsibility that steriliser validation is properly conducted. It is a bit onerous to need to be the expert instead of the technician.
Instead here is a quick checklist for you to pick a suitable technician:

  1. Do they also service and repair sterilisers?
  2. Do they provide a validation certificate and records?
  3. Will they remind you when validation is due again?
  4. Do they require staff to supply a range of “usual packs” of instruments?
  5. Do they require biological indicators to be incubated over time so they DO NOT provide immediate certification?

Rather than push responsibility back to the dentist for being a steriliser technician the ADA could consider an “ADA approval” process for those who service and do validation on office based sterilisers.

New to SmartDentist: You can upload your validation certificate into SmartDentist.

HOW TO SAVE YOUR VALIDATION CERTIFICATE:

  1. Add your Steriliser to Equipment Register
  2. Set up a Service timetable
  3. When the service is due and completed upload the validation certificate and the service timetable will re-date to the next service time.

Sterilizer records for dental practice

[or how to put your old Mobile phone to good use]

Login to SmartDentist and check out the “Steriliser Documents and Monitoring Policy”, or if you aren’t part of SmartDentist look at the ADA guidelines for Infection Control P28 (and P20).

How do you improve the efficiency of your document storage and collection?

  1. Establish a routine. Doing the same thing for every instrument is most efficient although it isn’t required. If staff don’t need to work out separate processes for different instruments the time saving is immense.
  2. Use an old Mobile Phone. Are you collecting paper copies of sterilisation documents? If you are then use an old mobile phone to take photos of printout and your sterilisation log sheets and download these when the phone gets full. You can leave the phone with its charger in the steri room. The additional benefit is that the photo’s taken with the phone will be dated (make sure it is always charged so the date is correct)
  3. Sterilisation log book -(our practice has a sterilisation log page). All tests are recorded within the one sheet. Our packs are labeled with a date and cycle self-inking stamp; and so it out sterilisation log page. The sterilisation log page can be scanned onto the computer (make sure it is located somewhere so it is saved for 7 years e.g. into patient computer software is ideal) for storage or a photo can be taken and the image stored.

See SmartDentist’s Reference and document links page to download a sample Sterilisation log page as this might help you with your own system.
SmartDentist also has a “What tests do I need for my steriliser?” aid. See RESOURCES.

Infection control of hands [Week 3]

IMG_1757The ADA guidelines say you need in your infection control manual…

Information and specifications in the manual must include:
• methods of hand hygiene (both routine and surgical);

SmartDentist subscribers: Go now and delete you old hand hygiene policy and go to the Common Policy Library and select the latest Hand hygiene Policy. It will come with links to

  1. Hand Hygiene Australia ;
  2. My favourite youtube video on Hand Hygiene;
  3.  WHO: Hand wash and Hand rub poster;
  4. Donning surgical gloves (Ansell site)
  5. Latex allergy help site.

TASK for this week
Download the Hand hygiene poster; save it to a UBS; go to Office Works and get a copy printed for each wash sink (0.88 cents per copy) and laminate it (1.75 per copy).
Get some blue tack and put them up at work!
(See picture above: I really do do what I say. Here is a selfie of me with the 5 posters – one for each surgery and one for the steri-room)

 

 

Let’s follow the ADA [WEEK 2]

Let’s follow the ADA [WEEK 2*]Screen Shot 2016-02-05 at 4.16.03 pm

The Dental Board says you MUST have your own infection control manual.
So what does that look like? Guess what. There isn’t ‘one’ answer to that question.
But we are going to follow the ADA guidelines with our OWN manual.
To save you checking what the ADA guidelines says you need to include in an infection control manual I have copied the text from P31. (see below)

This week’s 5 minute infection control task* is to login to SmartDentist.com.au and go to POLICIES and find the link to the Common Policy Template Library. You will find a list with all our infection control policies. There are 16 in my list so make sure each one of these policies is ADDED to your policy list. This is very quick and I don’t expect you to read them at this time – just make sure you have added them in preparation for our future blog articles.
If you don’t subscribe to SmartDentist you could audit your policies against this list or alternatively start a Word Doc with the list so you can begin to create your own infection control manual.

(From P31 of ADA guidelines for infection Control 2015-
Information and specifications in the manual must include:
• methods of hand hygiene (both routine and surgical);
• personal protective equipment requirements;
• setting up the treatment area between patients;
• environmental cleaning protocol;
• defined zones that require barrier protection and cleaning between patients;
• protocol following an exposure incident, e.g. a sharps injury;
• handling and disposal of sharps;
• waste disposal;
• processing of reusable items (cleaning, packaging, sterilisation, disinfection, storage);
• processing of radiographs in a manner to avoid cross-contamination;
• quality control mechanisms including documentation for the maintenance and monitoring of equipment;
• immunisation requirements;
• single-use items;
• recording of information during patient treatment in a manner to avoid cross-contamination;
• use of computers and computer-run equipment during patient treatment in a manner to avoid cross-contamination;
• management of waterlines used in direct patient contact; and
• handling latex allergy in dental patients and dental staff.
Practice infection control manuals must be regularly updated if and when new guidelines are produced by the Dental Board, the ADA or the NHMRC.)

[* Each week we will be looking at infection control compliance – just for 5 minute.]

Who sets the rules for dental infection control? [WEEK 1]

Who sets the rules for dental infection control? [Week 1]football-referee-with-hand-gestures_318-42804.png

Many dentists and staff get quite confused about the rules for infection control.
The Dental Board is the government regulator of dentistry and they say that dental practices should use 3 documents to guide their infection control procedures.

The documents are:

  1. The Australian Standard for reprocessing instruments (e.g how you clean and sterilize instruments) . Unless you are a hospital you will use AS 4815. An alternative standarad is a new version of AS 4187. This is a very very hard standard to meet so just ignore it for now. SmartDentist subscribers have access to AS 4185  via their login. It is 97 pages long and was finished in 2006.
  2. Australian Guidelines for the Prevention and Control of Infection in Healthcare published by the National Health and Medical Research Council (NHMRC). This document is available online and was finished in 2010 and is 262 pages long.
  3. ADA guidelines for infection control. This has just been revised and is about 50 pages long.

So why have 3 documents, and why don’t they just tell us what to do?

  • Each document is different. Yes, sometimes they can be interpreted to be in conflict or at least not clear about requirements.
  • The easiest document to read and understand is the ADA guidelines.
    ABOUT THE ADA GUIDELINES: Because the ADA is an organisation of dentists it is easy to understand that a government regulator would not be happy in just letting dentists decide on their own standards. Similarly the ADA looked at the other 2 documents which have wide ranging membership and tried to be practical and sensible in what it says dentists should do and use out of those other documents.
  • These documents are the source to go to if you are in dispute about what should be done in your practice.
  • You DON’T really want people to tell you exactly what to do because they don’t work in your building, with your equipment, with your staff or know exactly how your workplace functions. For example; in a big hospital do you need a first-aid kit when staff have access to emergency hospital care; do you need a designated spill kit for large spills of blood in a suburban dental clinic.
  • *When a sales person say…the ADA now requires you to ‘x’ then ask them to show you in the ADA guidelines before you buy their sales item. The ADA is not the government or controling body of dentists. They are a voluntary organisation.

Order of priority (by me)

  1. ADA guidelines: if that still does not solve your dilemma then –
  2. NHMRC guidelines for an overview of concepts and information apon which to base a decision.
  3. AS 4815 on technical requirements for sterilising and record keeping – just remember that it is nearly 20 years old and some things weren’t even invented e.g. USB sticks instead of printers.

NOTE: For those that play tennis, have a hit of golf or drive –

  1. Rules of Tennis – 30 pages
  2. Rules of Golf – 208 pages
  3. Road Rules NSW – 188 pages

 

Closer scrutiny -infection control in dental practices

“But no-one  else I know is…”

The most common complaint I have heard from dental practitioners, who have been “required” to make changes to their infection control practices, is that no-one else is actually doing what they are now required to do.
Of course this isn’t true but we do all have a universal wish to be treated fairly and to conform to the ‘norms’ of our peers.

The Dental Board of Australia (the Dental Board) should be commended for holding a forum of infection control stakeholders in late 2015.

The DBA got together with the ADA, consumer reps, the State regulators of dentists and representatives of the Australian Commission on Safetyand Quality in Health Care.
With the numerous cases of infection control breaches in NSW that have resulted in massive patient notifications about the risk of acquired infections, it isn’t a surprise that government bodies and regulators are really keen to have conformity and a universal standard of excellence for dental practices in infection control.

It will be interesting to see if the DBA chooses to include accreditation as a formal requirement for Dental Practices in the future.

Dental Council of NSW – making dentist uncomfortable

NSW Dentists are feeling uncomfortable

“The Dental Council of NSW is conducting an audit of infection control measures in dental practices.”
So stated an offical letter to all NSW Dentists. 

Not withstanding the proviso that it only applied to NSW Dentists who have an open complaint, it is a good idea to work through the directives from Dental Council of NSW and see that you have everything in order.

One of the requirements is a completed DBA Infection Control Guideline Self-Audit. Check out how SmartDentist answers the audit. 
Some practical practice resources:

  1. DBA Infection Control Guideline Self-Audit by SmartDentist.
  2. Sterilizer (autoclave) log sheet to use for your logbook.
  3. What tests do I need for my steriliser? by SmartDentist

Disaster recovery worst practice: Don’t test your backups.
Tomorrow I go into the clinic just to meet our IT specialist and we are going to do a backup recovery of our patient management software.
Similarly the DBA self-audit does take a bit of thinking and time – but helps get rid of that uncomfortable feeling we would all have, if we were queered by the Board.

Whether you are in NSW or another state…do the self-audit and smile.
🙂
Warm wishes for Christmas
Holiday well.