1. Legal Issues, Quality Assurance, and Infection Control
Chapter 40
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 1

2. Chapter 40 Lesson 40.1
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 2

3. Learning Objectives Pronounce, define, and spell the Key Terms.
Describe the components of informed consent with regard to dental radiographs.
Describe the types of laws affecting the practice of dental radiography.
Describe the Consumer-Patient Radiation Health and Safety Act.
Identify the individual who “owns” dental radiographs.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 3

4. Introduction
As a dental assistant, it is your responsibility to understand the laws that apply to you when you are exposing dental radiographs.
Both federal and state regulations control the use of dental x-ray equipment.
To ensure the highest quality and minimal risk to patients in radiation exposure, a quality-assurance program is necessary.
Dental radiography procedures are not usually considered high-risk for the transmission of diseases. However, infectious diseases present a significant hazard in the dental office and dental professionals are at an increased risk of such diseases.
Who are infection-control guidelines designed to protect? (Both patients and employees.)
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 4

5. Legal Issues
There are three major categories of legal considerations with which the dental assistant should be familiar in regard to the use of x-rays in dentistry:
Federal and state regulations regarding x-ray equipment and its use
Licensure for individuals exposing radiographs
Risk management for avoiding potential lawsuits
Who determines the qualifications for licensure for individuals obtaining radiographs?
What act mandates that those taking radiographs be trained and certified?
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 5

6. Federal and State Regulations
The use of dental x-ray equipment is regulated by both federal and state regulations.
All dental x-ray machines manufactured or sold in the United States after 1974 must meet federal regulations which include safety specifications for minimum filtration and accuracy of the milliamperage time and kilovoltage settings.
Many states require x-ray machines to be registered and charge a fee for this registration.
Most states have laws that require inspections of dental x-ray equipment on a regular basis, for instance, every 5 years.
What are some quality control tests that ensure x-ray equipment meets safety standards?
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 6

7. Licensure Requirements
The Consumer-Patient Radiation Health and Safety Act is a federal law that requires persons who take dental radiographs to be properly trained and certified.
It is up to the individual state to determine its own policy regarding the qualifications of individuals exposing radiographs.
X-ray certification requirements for the dental assistant vary from state to state.
Some states require certification by the Dental Assisting National Board; other states may require an additional examination.
Each state deals with dental radiography differently.
What is the purpose of requiring licensure for persons who take radiographs?
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 7

8. Risk Management
Risk-management policies are designed to reduce the likelihood of a malpractice lawsuit against the dentist.
The dental assistant has an important role in risk management.
The dental assistant must be careful never to say anything negative about the x-ray equipment or how it is working.
Statements made without thinking—such as “The timer must be off,” “This thing never works right,” or “The solutions are weak”—are unnecessary and can make the patient feel uncomfortable.
Statements made by anyone at the time of an alleged negligent act are admissible as evidence in court.
Can a dental assistant be sued for malpractice or negligence? (These liabilities are typically the dentist’s responsibility, but there are some actions for which an assistant can be held accountable.)
What is the dental assistant’s role in risk management? (Dental assistants can help design quality-assurance programs and, because they interact often with patients, it is important for them to project an air of confidence and competence.)
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 8

9. Informed Consent
It is the dentist’s responsibility to discuss the need for radiographs and treatment procedures with the patient.
The dental assistant may participate in the process of obtaining informed consent.
Patients must give informed consent for dental radiographs, as well as for other procedures.
What information is required for informed consent?
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 9

10. For Valid Informed Consent
The patient must be provided with the following information in lay terms:
The risks and benefits of the radiographs
The person who will be exposing the radiographs
The number and type of radiographs
The consequences of not having the radiographs
Any alternative diagnostic aids that may provide the same information as the radiographs
The dental assistant must be very careful to use lay terms (e.g., for “amalgam” and “composite”) in a way that patients understand.
Dental assistants should not oversimplify an explanation.
Calling radiation harmful might make a patient uneasy. Explain to the patient that many common things are harmful in excess. Radiation is something patients are exposed to every day by being in the sun.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 10

11. Liability
Under state laws, the supervising dentist is legally responsible, or liable, for the actions of the dental auxiliary.
This is called respondeat superior doctrine. It means that the employer is responsible for the actions of the employee.
However, even though dental assistants work under the supervision of a licensed dentist, they can also be held legally liable for their own actions.
When might an assistant be held liable? (Anything done maliciously.)
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 11

12. Patient Records
It is very important to document the exposure of dental radiographs.
The number of films exposed, as well as the quality of the radiographs, may be an important issue in a malpractice suit.
Radiographs that are of poor quality and are nondiagnostic reflect poorly on the dentist.
Nondiagnostic radiographs are sometimes unavoidable, but a competent technician can keep these to a minimum.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 12

13. Documentation of Dental Radiographs
The dental record must include the following information:
Informed consent
The number and type of radiographs exposed
The rationale for exposing the radiographs
The diagnostic interpretation
The diagnostic interpretation must be made by the dentist.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 13

14. Ownership of Dental Radiographs
Radiographs are the property of the dentist, even though the patient, or the patient’s insurance company, paid for them.
This is because dental radiographs are a part of the patient’s records.
Patients have a right to reasonable access to their records.
Make an entry in the chart stating when and to whom duplicate radiographs were sent.
Never give or send the original radiographs to a patient.
Some patients may have trouble understanding that they do not own the radiographs. Explain to them that they are paying for the interpretation or diagnosis of those radiographs.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 14

15. When Patients Refuse Dental Radiographs
When this occurs, the dentist must decide whether an accurate diagnosis can be made without radiographs and whether treatment can be provided.
The use of dental radiographs is now the accepted standard of care.
No document can be signed to release the dentist from liability. Even if the patient suggests signing a release or waiver that will release the dentist from liability, it would be considered invalid if an injury did result.
It should be recorded in the patient’s record if a patient refuses recommended radiographs. The dentist must then choose whether or not to continue treating this patient.
A dentist should never work without a current radiograph of the problem area.
Patients who refuse x-rays need to understand that the risk from radiation is minute compared with the risk of working without a radiograph.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 15

16. Patient Education
As a dental assistant, you should understand and be sensitive to the patient’s concern and fears about exposure to radiation during dental radiographs.
The dental assistant is often the person to whom the patient feels most comfortable confiding these fears.
The dental assistant can explain to the patient just how important radiographs are in detecting diseases and planning treatment.
Patients can be informed of the federal and state laws enacted for their protection.
Pamphlets can also be used as an educational aid.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 16

17. Chapter 40 Lesson 40.2
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 17

18. Learning Objectives
Name the eight annual tests recommended for x-ray equipment.
Describe the components of a quality-assurance program.
Describe the quality-control tests for processing solutions.
Explain the use of a stepwedge.
Discuss the purpose of a reference radiograph.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 18

19. Quality Assurance in the Dental Office
Quality assurance is a means of ensuring that everything possible is being done to produce high-quality diagnostic radiographs.
It includes both quality-control tests to monitor the condition of dental x-ray equipment, view boxes, supplies, and film processing and quality-administration procedures, including records of maintenance and other logs.
Although the dentist is responsible for ensuring that these things are done, the tasks themselves are typically left for the assistants.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 19

20. Fig. 40-2 Viewbox with clean Plexiglas and new bulb.
Scratched Plexiglas or dim bulbs can make radiographs difficult to read.
Maintenance of these items is part of quality assurance.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 20

21. Fig. 40-3 A, Unexposed film with coin on it.
This is used to test the safelight.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 21

22. Fig. 40-3 B, Radiograph showing outline of coin.
The safelight is unsuitable for use.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 22

23. Fig. 40-4 Radiograph of a stepwedge.
This is used to ensure that the developer solution is of the proper strength.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 23

24. Chapter 40 Lesson 40.3
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 24

25. Learning Objectives
Explain the infection-control requirements for preparation of a radiography operatory.
Implement the Centers for Disease Control and Prevention guidelines for infection control in dental radiology.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 25

26. Infection Control in Dental Radiography
Dental radiography presents unique infection-control problems because of the potential for operator contamination and cross- contamination of other patients and other members of the dental team.
Constant movement by the operator from the oral cavity to the exposure controls outside the operatory to the darkroom and finally to film mounting increases the risk that others will be exposed to infectious diseases.
When film with an outer barrier is being used, the barrier should be removed and the film placed in an aseptic container. This will keep the darkroom aseptic.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 26

27. Surfaces Likely to Become Contaminated During Dental X-Ray Procedures
X-ray tubehead
Position-indicating device (PID)
X-ray control panel
Exposure button
Lead apron
Dental-chair controls
Operatory counter surfaces
Darkroom equipment
Sleeves on automatic processors
All of these surfaces should be covered.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 27

28. Radiography Operatory Preparation
The first step in the preparation of the operatory is to determine which surfaces need to be covered or disinfected with a high-level surface disinfectant.
In general, surfaces that cannot be easily cleaned and disinfected should be protected with a barrier, most commonly plastic or foil.
Surface barriers are preferred for electrical switches because of the possibility that the cleaner or disinfectant will cause an electrical short.
The operatory should be completely prepared before the patient is brought in.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 28

29. Fig. 40-6 Radiography operatory with barriers in place.
The barriers should be changed after each patient.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 29

30. The X-Ray Machine
The tubehead, PID, control panel, and exposure button must all be covered or carefully disinfected.
Because disinfectant must sit on a surface for 10 minutes to work, it is best to use barriers in a busy operatory.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 30

31. The Lead Apron
The lead apron should be considered contaminated and wiped down with a disinfectant after each use.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 31

32. The Dental Chair
The back and arms of the chair, the headrest, and the headrest-adjustment controls must all be covered or disinfected.
Once the radiography operatory is set up, the film and film-holding devices should be prepared.
Working neatly, especially while a full-mouth series is being taken, helps speed the series and ensures that the same area is not accidentally exposed twice.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 32

33. The Work Area
The work area where the x-ray film and film-holding devices are placed during exposure should be disinfected, after which a barrier should be placed.
This barrier may be a paper sheet, paper towels, or plastic cover.
Once the procedure has been completed, the barriers should be discarded. Surfaces that are not protected with barriers should be cleaned and disinfected.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 33

34. Fig. 40-7 A, Plastic surface barrier is placed over the work surface
Fig A, Plastic surface barrier is placed over the work surface. B, After each exposure, the dental assistant wipes the film dry using a paper towel and then places the exposed film in a plastic bag that has been taped to the wall. (Courtesy of the University of California School of Dentistry, Oral Radiology Department; photographs by Thomas Cao.) A B
An empty plastic cup works just as well as a plastic bag.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 34

35. Preparation of Supplies and Equipment
To help decrease the chance of cross-contamination, gather all of the supplies that you might need before beginning the procedure.
For example, think about the type of film-holding devices, cotton rolls, and bite-wing tabs that may be needed if the patient has an edentulous area.
If you need additional supplies during the procedure, either use overgloves (food handler’s gloves) or ask someone for assistance.
Preparation is important both for infection control and time savings.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 35

36. The Film
Dental film should be dispensed from a central area in a disposable container, such as a paper cup or envelope.
A clear plastic barrier envelope may be placed over the film packet to minimize contamination by saliva.
Films enclosed in clear plastic barrier packets are available commercially.
The barrier-protected film packets are exposed and brought to the processing area.
The barriers are contaminated; the dental assistant must remove them very carefully, without touching the inner packet, so that he or she can handle the packet with bare hands.
It is best to dispose of the barrier before bringing the films to the processing area.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 36

37. Fig. 40-8 Protective barrier on x-ray film.
Remove the barrier over an aseptic container, such as a plastic cup, and allow the exposed film to drop into the cup without touching it.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 37

38. Contaminated Film Packets
The contaminated film packet is the major source of cross-contamination during radiographic procedures.
When the packet is removed from the patient’s mouth, it is coated with saliva (or, on occasion, with blood).
For this reason the operator must always wear gloves while handling contaminated film packets.
Any film that goes into a patient’s mouth, not just film with blood on it, is considered contaminated,.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 38

39. Decontamination of Film Packets
Wipe saliva from the film packet using a dry
2 × 2-inch gauze sponge or a paper towel.
Do not attempt to sterilize the film packet. Heat sterilization will destroy the image.
Some film manufacturers permit light spraying of film packets with a disinfectant spray; however, immersion of the packet in a disinfecting solution can allow solution to seeping into the emulsion, damaging the image.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 39

40. Film-Holding Devices
Film-holding instruments and bite-blocks that are placed in the patient’s mouth are semicritical items and must be sterilized or subjected to high-level disinfection before reuse.
The alternative is to use disposable film holders and discard them after a single use.
Sterilized film-holding devices should remain packaged until the patient is seated and the patient can view the opening of the package.
Patients appreciate knowing that proper infection-control procedures are in place throughout the office.
Extension-cone-paralleling (XCP) devices should be placed in a sterilization pouch and steam-sterilized.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 40

41. Miscellaneous Items
Other useful items include cotton rolls that can be used to stabilize film placement and paper towels that can be used to wipe saliva from exposed films.
A disposable container, such as a paper cup labeled with the patient’s name, is also necessary to collect the exposed films.
All miscellaneous items should be dispensed from a central supply area.
Patients may wish to have a tissue as well to wipe saliva from their face. Saliva may get on the patient’s face while films are removed or if the patient drools while holding the bite-block in place.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 41

42. Preparation of the Operator
Gloves and protective clothing must be worn by the dental assistant exposing radiographs and handling contaminated films.
Because radiographic procedures do not involve the aerosol produced by the dental handpiece, a mask and glasses are optional while radiographic films are being made.
If the patient has a cold or allergy, glasses and a mask should be worn.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 42

43. Fig Wearing the appropriate personal protection, the operator places the lead apron on the patient.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 43

44. Infection Control During Exposure
After gloving, the operator should be careful not to touch any surfaces that have not been covered.
The best way to do this is to develop a sequence in which the operator touches as few surfaces as possible.
After each exposed film is removed from the patient’s mouth, it must be wiped with a paper towel to remove excess saliva.
Barrier films only need the barrier removed rather than being wiped.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 44

45. Collection of Contaminated Films
Once dried, each film must be placed in a disposable container (plastic bag or paper cup) labeled with the patient’s name.
This container will be used to transport the films to the darkroom.
The outside surface of this container must not be touched by gloved hands.
As a means of preventing film fog caused by radiation, the container should never be placed in a room where additional films are being exposed.
Exposed films should never be placed in the operator’s laboratory or uniform pocket.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 45

46. Film-Holding Devices
During exposure, film-holding devices should be transferred from the covered work area to the patient’s mouth and then back to the same area.
Contaminated instruments should never be placed on an uncovered surface.
What should the dental assistant do if he or she accidentally places a contaminated instrument on a covered surface? (Use a high-level disinfectant on the surface for 10 minutes, then wipe it clean.)
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 46

47. Management of Contaminated Items After Exposure
After completion of film exposure, all contaminated items must be discarded and any uncovered surfaces must be disinfected.
Contaminated radiography items must be handled in the same manner as that recommended for other contaminated dental instruments.
The dental assistant must wear gloves to discard contaminated items, including the disposable surface coverings.
The operator should carefully unwrap all covered surfaces; the actual surfaces that are wrapped should not be touched by gloved hands.
(Cont’d)
For added infection control, lightly spray the uncovered surfaces before rewrapping.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 47

48. Management of Contaminated Items After Exposure
(Cont’d)
Film-holding devices
While the operator is wearing gloves, the contaminated film-holder must be removed from the treatment area and placed in the area designated for contaminated instruments.
Handwashing
After the removal and disposal of all contaminated items, gloves must be removed and the hands washed.
Surface disinfection
Any uncovered areas that were contaminated during exposure must be cleaned and disinfected with the use of an Environmental Protection Agency-registered hospital-grade disinfectant and utility gloves.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 48

49. Film Transport
The disposable container should never be touched by gloved hands.
Only after the gloves have been removed, the hands have been washed and dried, the patient has been dismissed, and the area has been cleaned and disinfected should the operator carry the disposable container holding the contaminated films to the darkroom.
Avoid leaving an operatory contaminated, even if you plan to come back later and clean it up. The contaminated operatory may be entered by another person, unaware of its contaminated status, who may then contaminate other areas of the clinic.
Copyright © 2009, 2006 by Saunders, an imprint of Elsevier Inc. All rights reserved. 49