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

 

 

Flu shots and immunisation for dental staff

Time for Flu shots and immunisation checks for dental staff

Get the flu shot immunisation today

It’s never too late to vaccinate/ immunisation for health

There is nothing that bonds all the dental team together better than having your flu shots at work!

Why now?
April is the ideal time to arrange your flu shots. The peak season for flu is late July August so having the flu shot now means you will build up immunity by the time the risk of catching the flu is greatest.
Flu vaccinations are one of the recommended vaccinations for healthcare workers (or anyone in contact with the public!)

Immunisation for Dental Staff

The ADA’s latest News Bulletin outlined the requirements for Dental Staff immunisation. SmartDentist subscribers have an easy way to meet staff immunisation obligations. To find out more you and your staff can do an online training course on the flu and your immunisation obligations. This will earn you CPD points as well!
Dental practices with accreditation need to fulfil staff training obligations so encourage each staff member to learn and join in the conversation about immunisation, the flu and infection control.

SmartDentist is the easy solution to fulfilling all your immunisation requirements with:

  • a practice policy that includes management of staff refusal;
  • employee and pre-employment immunisation forms;
  • an immunisation register;
  • information for staff on vaccine preventable diseases

Mandatory immunisation of healthcare workers

Queensland Health now require job applicants for dental roles to supply evidence of vaccination or evidence that they are not susceptible to prescribed vaccine preventable diseases.

Dental practices would be wise to follow the lead of Queensland health and use their pre-employment forms and their evidence criteria (all available online).
SmartDentist has pre-employment forms and recommends dental practice adopt this vaccination requirement for new staff. It helps streamline the practices obligations and reduces stress if a sharps injury occurs.

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