Addressing the Risks and Liabilities of Chairside Services (Regulatory Standards CE)

It is recognized in the dental industry that the relationship between dentists and dental technicians is evolving into more complex cooperative patient treatment efforts. Technology seems to be driving the need for chairside services. These services can include:

• Performing shade-taking or verifications
• Making adjustments/alterations/repairs
• Fabricating implant and conventional set-ups
• Scanning intraoral digital images
• Consulting on implant guidance
• Consulting on material choice
• Performing intraoral verification
• Fabricating immediate device (or denture) conversion
• Taking photographs during patient treatment

This opportunity appears to be welcomed and embraced by dentists and dental technicians. As with most business models, there are risks and liabilities that both parties need to address. Prior to the actual performance of these services, business owners should conduct a risk management analysis in order to identify loss exposures before they occur. This analysis should address the scope of the services, legality of performance of the services, liabilities to both parties during the performance of these services, and regulatory requirements that apply. This course is intended to provide the basic considerations that should be agreed upon beforehand by the dentist and dental laboratory to protect the dentist, dental laboratory owner, dental technician, and patient.

Legality of the Performance of the Services

Every state's Board of Dentistry and Dental Practice Act regulate the relationship between the dentist and the dental laboratory. That means that each state can handle it differently and in some cases may not address this business relationship at all. Some states define a dental laboratory, require registration, and define the services that can be provided by the laboratory, but some don't. Most states only require a prescription to authorize an unlicensed person to perform laboratory services and do not mention where the services can be performed. 

Here are some questions applying to state laws that should be answered prior to agreeing on chairside services: 1) Are dental technicians allowed to perform work for the dental laboratory outside the physical location of the dental laboratory? 2) Are there any limitations on the services the dental technician can perform if permitted to work in the dental office with patients? 3) Does the state have specific educational requirements or licensing requirements for anyone allowed to assist with conversions or other work? 4) Are there any state laws that cover whether the dentist has liability for the dental laboratory's dental technician when performing chairside services? 4) Are there any limitations on the rights of the dentist to delegate work or services to a patient by a non-dentist individual? 5) Are there any state laws that apply to the use of a mobile dental laboratory? 6) Does the authorization (prescription and/or work authorization) by the dentist to the dental laboratory define the scope of the service to be provided by the dental technician in the dental office and is it clear when the service begins and when it ends?

Insurance for Liability Concerns

As with most insurance, business owners don't always understand the coverage they have until they need to use it. Insurance coverage for the performance of chairside services can include product liability, workers' compensation, professional liability, and property damage. Both the dentist and the dental laboratory owner should inform their insurance carrier/broker of these activities. They can then be advised on the limitations of their current coverage and determine which entity (dental practice or dental laboratory) should maintain the coverage. The following are some insurance coverage considerations.

Devices fabricated in dental client's office:Does the dental laboratory's product liability coverage protect against items fabricated in the dental office? Product liability insurance covers the safety and performance of the device and may only cover the device when manufactured at the primary place of business.

Interactions with patients:If the patient is injured as a result of the product that is fabricated in the dental office by the dental laboratory's dental technician, does the dental laboratory's product liability insurance or other insurance protect the laboratory? Does the laboratory have professional liability coverage  (for errors and omissions) that includes the acts of the laboratory's dental technician while on-site at a dental practice performing the services requested? Does the dental practice's professional liability coverage protect the dental laboratory's technician should there be a lawsuit by a patient for work performed while the dental technician was on-site and participating in treatment?

Miscellaneous liabilities: Whose workers' compensation insurance covers the laboratory dental technician while on dental office premises? Workers' compensation insurance covers injury to a worker while on the job. Does the laboratory's business owner's policy cover the equipment or other property that the laboratory's dental technician takes to the dental practice to perform the service? If a mobile dental laboratory is being used by the dental laboratory, how do these types of insurance coverage affect that type of operation?

Other Regulatory Considerations

The Food and Drug Administration (FDA) requires dental laboratories to develop and implement a Quality System (QS) based on the Quality System Regulation at 21 CFR Part 820.¹ Such affected sections of the QS can include: 1) Standard Operating Procedures and Work Instructions that indicate that manufacturing is performed in locations other than the primary physical location of the dental laboratory; 2) the existence of work authorizations for the design input from the dentist; 3) documentation of the competency of the dental technician to perform the services; 4) evidence of preventive maintenance on equipment that is provided by the dentist and used in the fabrication of a dental device; 5) selection process for patient contact materials provided by the dentist for the fabrication of the dental device; and 6) cleanliness and decontamination procedures in place in the area where the dental device is fabricated.

Safety of the dental technician

The dental laboratory owner must protect the dental technician when at an off-site facility providing services. This part of the course will address how the dental laboratory can establish safe practices to protect its employees. In the following information, the location where the chairside services are performed will be referred to as the “off-site facility.”

Hazard communication

The Hazard Communication Standard² requires employers to identify hazardous materials, provide education and training to employees exposed to the materials, and use administrative and engineering controls to eliminate or minimize the hazards. There are a number of considerations when chairside services are performed at off-site facilities and the materials are provided by the off-site facility. It is best for laboratories to be proactive and prepare ahead of time. Laboratories should train employees on the hazards of the material upon hire, when new chemicals are introduced into the workplace, and when employees move to another workplace where there are hazardous chemicals. A Safety Data Sheet (SDS) should be provided for the chemicals. When materials are used outside of the dental laboratory, then the dental technician must have access to the SDSs used at the off-site facility. Lastly, chemicals should be labeled to provide immediate warning of any relevant hazards to the worker.

Equipment use

If the dental technician is taking equipment to the off-site facility, then training on the use of the equipment is the responsibility of the dental laboratory owner. If the off-site facility is providing the equipment to be used by the dental technician, then the off-site facility will provide training on safe use of the equipment, ie, digital imaging acquisition unit, camera, etc.

Restricted areas in the off-site facility

The off-site facility will inform the dental technician of the risk areas and any areas where access is restricted to the off-site facility's employees. This restriction could be due to possible exposures to chemical hazards, equipment hazards, biological hazards, and radiation.

The dental laboratory owner should instruct the dental technician on the protocol to be followed when the technician's presence is requested in the patient treatment room by the off-site facility, ie, contact with the patient, supervision during patient treatment.

The dental technician must abide by the off-site facility's rules regarding eating, drinking, smoking, and/or use of consumables in the off-site facility's risk areas. Good hand hygiene practices must be observed such as washing hands before and after gloving and using the restroom.

Disposal of biohazard waste and sharps

The off-site facility will inform the dental technician on the use and location of biohazard waste containers for the proper disposal of contaminated personal protective equipment (PPE) and any other potentially infectious items. Also the location and use of sharps containers will be explained to the dental technician for the proper disposal of sharp items.

Personal protective equipment

The dental laboratory owner must ensure that the dental technician is provided PPE when administrative and engineering controls do not eliminate exposures. The employer is responsible for providing PPE at no charge to the employee. When the services being performed at the off-site facility require the use of PPE, then the dental laboratory owner must provide the PPE or make arrangements with the off-site facility to provide the PPE. The dental laboratory owner must determine the risks of exposure at the off-site facility and train the dental technician on the safety precautions, including the use of PPE.

Handling potentially infectious items

Infection control procedures must be developed in order to provide guidelines for the safety of the dental technician from cross-contamination and exposure to biological hazards. These guidelines must take into consideration OSHA's requirements under the Bloodborne Pathogen Standard³ and the Centers for Disease Control's (CDC) recommendations for infection control in dentistry dated 2003⁴ and 2016.⁵ The dental laboratory owner must offer the Hepatitis B vaccine to its dental technicians who provide these types of services. The refusal or acceptance by the dental technician must be documented.

Establishing Infection Control Protocols

The following are components of an Infection Control Protocol to be developed for the protection of the dental technician.

Universal precautions

Use Universal or Standard Precautions in the handling of every item that has been in contact with the oral cavity. The dental technician should not assume that these items have been properly disinfected by the off-site facility’s staff.

The dental technician should have access to an area with a sink in order to disinfect all items that have been in contact with the oral cavity prior to further handling of the item. This includes wearing safety eyewear, gown, gloves, and mask, as well as disinfecting counters and work surfaces using a spray-wipe-spray method.

Tag and mark impressions with the proper identification so that they will be returned to the correct pan after having been disinfected and poured. Rinse all items that have been in a patient’s mouth, and place items in a container for disinfection. However, if after rinsing with water, the item still contains visible blood, then soak in an appropriate cleaner, such as an enzyme cleaner, to remove blood. Then rinse prior to continuing with disinfection steps below.

Follow the manufacturer of the impression material’s instructions for proper disinfection of impressions. The CDC recommends at a minimum using a hospital-grade, EPA-registered, intermediate-level tuberculocidal disinfectant. Completely spray, soak, or submerge item in disinfectant to reach all surfaces. Set timer for indicated time that the disinfectant label indicates to kill tuberculosis (mycobacterium tuberculin). Once the time has been met, rinse the item under water. After clearing it of all items, disinfect the counter. When everything has been disinfected, remove gloves, dispose of them properly, and wash hands.

Repairing appliances

When repairing appliances that have been in the oral cavity, the dental technician must also take the necessary precautions to prevent exposure to biological hazards. The first steps are wearing a gown, mask, and safety eyewear when working on appliance repairs. Do not use the same pumice for new work and repair work. For repairs, pre-measure pumice in small amounts and discard it after use. Soak brush wheels and rag wheels used on items that have been in a patient’s mouth in a disinfectant. Completely spray, soak, or submerge item in disinfectant to reach all surfaces. Rinse and air-dry overnight. (Consider the use of disposable items whenever possible instead of disinfecting these items.) After using pumice in a repair, disinfect the appliance using proper disinfection procedures as listed above. These materials are only surface disinfectants; when the surface is broken by grinding or using pumice, the appliance must be disinfected again.

When operating a model trimmer, brush trimmer, or rag wheel with pumice, technicians should wear a face mask and eye protection or a face shield. Keep a small bowl of disinfectant at the workbench where repair appliances will be ground or altered; soak item in disinfectant to reach all surfaces. Rinse. The pressure pot used for repairs should also be disinfected between repairs or the repairs isolated in a container prior to placing in the pressure pot. The final disinfection or sterilization of appliances should be the responsibility of the off-site facility unless state laws indicate otherwise.

Post Exposure Evaluation and Follow-up

Needlesticks, other percutaneous injury, or spray or splatter of body fluids sustained by the dental technician while at an off-site facility must be handled immediately by the off-site facility. The procedures to be followed by the dental technician must be determined by the dental laboratory owner and off-site facility. The incident must be documented on the appropriate Injury Form and the Post Exposure Evaluation and Follow-up procedure must be followed.

Handling of Emergency and Security Procedures

Since OSHA requires employers to be prepared to promptly handle emergency situations, the off-site facility should review its emergency and security procedures with the dental technician. After the initial training, any changes to the emergency action procedures and/or security procedures should be conveyed to the dental technician on the next scheduled visit.

Conclusion

There is a growing need for dental laboratory owners to provide chairside services to the dentist. To make this arrangement legal and viable for both the dentist and the dental laboratory, both should agree on the scope of the services, safety protection for the laboratory’s dental technician, and other risk management issues such as insurance coverage for product liability, product warranty, professional liability and general business liability. It’s advisable for both parties to consult with their legal teams to determine if a formal, written agreement should be entered into. That agreement may be known as a liability waiver or “hold harmless agreement” and is a document that provides an attempt to remove legal liabilities.

In summary, the steps for protecting your business and the employees providing the chairside services are to:

1. Define the services requested by the off-site facility;
2. Conduct a risk management analysis;
3. Explore legal requirements in the state where services are to be performed;
4. Determine the insurance coverage needed;
5. Verify regulatory requirements;
6. Seek legal advice for preparation of a written agreement; and
7. Establish safety protocols to protect the employee providing the services. Taking the time to recognize and resolve the liabilities that can be associated with chairside services protects the dental laboratory, the dental practice, and ultimately the patient. Addressing the issues discussed in this course prior to providing the services will help make this a mutually beneficial relationship.

About the Author

Mary A. Borg-Bartlett
President
SafeLink Consulting, Inc.

References

1. Medical Devices. Code of Federal Regulations, Title 21, Volume 8. US Food & Drug Administration web site. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1. Accessed April 1, 2017.

2 Hazard Communication. Occupational Safety and Health Administration web site. Available at: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 . Accessed October 17, 2017.

3. Bloodborne pathogens. Occupational Safety and Health Administration web site. Available at: www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051 . Accessed October 17, 2017.

4. CDC’s Guidelines for Infection Control in Dental Health-Care Settings (2003). Centers for Disease Control web site. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm. Accessed October 17, 2017.

5. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care (2016). Available at: www.cdc.gov/oralhealth/infectioncontrol/pdf/safe-care.pdf. Accessed October 17, 2017.