If My Dental Regulatory Body Does Not State, That I Need To Track And Track, Then Who Is Telling Me To Track And Trace?

If my dental regulatory body does not state specifically, that I need to track and trace, then who is telling me to track and trace?

A terrific question for any busy dental office to pose … who is telling me to track and trace?  To answer the ‘who’ one must understand the ‘why’.  Once the ‘why’ is understood through a risk management lens and professional responsibility to keep the public safe, the who loses its debate as you will be the person telling yourself to track and trace! 

Tracking and tracing are linking a sterilized package to the client it was used on.  Why do we label packages with the date, sterilizer #, load #, contents, and initialize? It is not just to label to see when it was sterilized but also where it’s going or in past tense, has gone. The label is the first step of having a recall system in place, it’s the tracking of packages. The label data then needs to be inputted into the clients’ clinical notes as a means of connecting,  and tracing, the sterilized package to the client. In the event of an IPAC lapse or a complaint from a patient, the office needs to promptly initiate an instrument recall. How would an office find where the packages went and what instrument or kits were used on a patient if it is not tracked and traced including the client's clinical notes? This would be as enjoyable as finding a needle in a haystack! Time-consuming in a situation that is beyond time-sensitive attached to the office’s reputation as a safe healthcare facility.

Can the office rely on the sterilization logs and the software appointment book?  No, because the instruments used are not simultaneous to the day and time they were sterilized. The flow of sterilized instrument distribution to operatories includes the use of instruments from the previous day, the previous week, or longer. If the office is quarantining to release once the BI outcomes are confirmed, there still needs to be a track and trace system.  Why? In the case of needing to prove the instruments used on Jane Doe were sterilized on this date, in this sterilizer, in this load, by this person is a critical piece of liability information. Quarantining delivers the validation that the sterilization process is successful, however, it does not tell what instruments were used on who. Quarantining offers internal validation only on the fact the office is 100% sure those instruments are sterilized as there is no waiting on pending results of the BI.  Dental professionals do not think of complaints from the public. Complaints are a possibility, a risk, therefore we must mitigate the risk and be ready.

Do dental offices use CPR every day? No, but because there is a risk, we mitigate the risk by having simulation emergency training as a risk management system to be ready in the unfortunate event it should unfold. It would be negligent if we were not ready to act efficiently and effectively in an emergency situation. This can be paralleled to an IPAC lapse whether the lapse is internal from a sterilization failure or external as an issued complaint,  it is an IPAC emergency. Is it worth the liability and stress of having a dental office inspection, a tarnished reputation, a lawsuit, or even a shutdown for not performing the mere task of inputting the package data in the client’s chart? Not worth it.  Personally, what do I do in my office? I track and trace. Have I had to recall packages, yes.  Have I found all of them, yes.  Did I divert a potentially horrible situation? Yes. Did the recall go well? Yes.  Why? My team was ready and knew what to do! What do dental educational facilities teach and what systems do they use? For years, they have tracked and traced and students input the package data in the client chart.

Is the establishment of a recall system a new concept?  Not at all as it’s a base element of a hospital and any offsite medical clinic reprocessing policies and procedures. As a matter of fact, it has always been stated in the Canadian Standards Association Group (CSA) reprocessing standards and updated in the latest edition from 2023 (CSA Z314:23). The CSA explains that without a track and trace system, the healthcare facility is vulnerable to a high level of risk. In the 2023 update, the CSA committee altered the name of the document to read “Canadian medical device reprocessing in all health care settings”.  Is a dental office a healthcare facility? Yes. Does it use medical devices for reprocessing? Yes. This means the CSA standards are a National Standard, a best practice resource that are applicable to dental offices in Canada. Furthermore, the newly released 2023 Reprocessing Standard 5.8.3.1.3. Risk Assessment states “a system of traceability (i.e. a system for documentation of label information into a patient treatment record)”.  This clearly defines WHAT a system means … “a system for documentation of label information into a patient treatment record”.  It does not get any clearer than this!

The CSA does not have the authority to enforce or police healthcare facilities, however, they are THE evidence-based body that offers National Standards. Perform a search and look at resources from a respectable IPAC authority like public health departments and note how their reference page cites CSA. Dental offices are unaware of the CSA standards as naturally dental professionals rely heavily on their dental regulatory bodies to disseminate information. Just because a dental office does not know CSA writes national standards, it does not mean there is no hierarchy in the writing of standards. One of the reasons why the CSA standards are not known is most likely because they are not complementary, the fee to purchase is $605.00. At times the dental regulatory bodies have not yet updated their standards or have perceived the trace and trace as a system the dental professional will take the onus to establish. As such, many regulatory standards have a blanket statement referring to something like, ‘there is a recall process in place’ or ‘there is a means of recalling instruments.’ Hint, hint! The dental regulatory bodies have done their due diligence.  They do not know EVERY office reprocessing system therefore cannot possibly state word for word what to do in a recall system in YOUR office. The torch is then passed to the dental professional to put their risk management glasses on break down all the counterparts of the possible risk and find a system to mitigate each point, including documentation into the client chart.

Let’s go back to the beginning.  Who is telling dental offices to track and trace?  You are when understanding why tracking and tracing is required and when looking at IPAC through a risk management lens. The $605.00 fee is a worthwhile investment for clarity placing YOU the dental professional in the driver's seat in the process of informed IPAC decision-making. Not tracking and tracing or only doing sub-parts of the system is an enormous risk when there are effective approaches available to have a comprehensive program that protects the public and safeguards the dental professional.

Michelle Aubé-Simmonds RDH

Michelle Aubé (Simmonds) RDH, maxill Dental Hygiene Educator

Michelle is a Dental Hygiene Speaker, Consultant and Educator with over 30 years of experience as a RDH and 4 years as a CDA. She is a professor and curriculum writer at Fanshawe College in both the dental hygiene and continuing education program sharing her knowledge in IPAC, professional practice, periodontal classification, social justice, advocacy and clinical applications. She is maxill's CE and IPAC Director and wears various IPAC hats including auditing federal correctional facilities dental clinics for IPAC standards. Michelle is ODHA's Regional Board Director and authors articles for CDHA's OH Canada professional publication and continues to practice clinically in London ON. She is a CDHO IPAC Remedial Facilitator and IPAC Expert Opinion. Her strong ethics has allowed her to serve on the Discipline Committee at Algonquin College and hold the position of a CDHO Quality Assurance Assessor for 7 years. As a lifelong learner she is completing a BA in Adult Education at Brock University. Her diverse dental background and current status as a practicing RDH offer a fulsome and realistic view of dental-related topics. As a passionate champion for the profession, she advocates for equity, professional autonomy, and systemic change, true grassroots leadership at its finest.

Michelle can be reached at michellea@maxill.com