Chapter 4715-20 Patient and Personal Protection

4715-20-01 Patient and personnel protection.

(A) Immunization - All dentists and dental health care workers must show evidence of immunity to or immunization against the hepatitis B virus as specified by board guidelines. Such immunization must begin prior to patient contact. Medical documentation must be maintained in the dental facility for each dentist and dental health care worker providing care in that facility. This medical documentation must be made available immediately upon request by an authorized agent of the state dental board.

(B) Hand hygiene:

(1) Hand hygiene methods and indications as recommended in table 2 of the United States department of health and human services, Centers for disease control and prevention's "Guidelines for infection control in Dental Health-Care Settings - 2003" must be utilized at all times, including, but not limited to:

(a) Before and/or after patient contact;

(b) Before glove placement and after glove removal;

(c) After touching inanimate objects likely to be contaminated by blood, saliva, or body fluids;

(d) Before leaving the dental operatory or laboratory;

(e) After removing gloves that are torn, cut or punctured; and

(f) When hands are visibly soiled.

(2) Reference materials for paragraph (B)(1) of this rule may be found at the centers for disease control and prevention, 1600 Clifton Rd., Atlanta, GA 30333, U.S.A.; telephone: (404) 639-3311; public inquiries: (404) 639-3534 / (800) 311-3435; internet website address: www.cdc.gov.

(C) Barrier techniques:

(1) Gloves - All dentists and dental health care workers must wear disposable gloves whenever placing their fingers into the mouth of a patient, or when handling blood/saliva contaminated items, instruments and equipment. Disposable gloves shall not be washed and/or reused for any purpose. Overgloving between patients is not permitted.

(2) Face protection - Chin length face shields, or masks and eyewear with protective side shields must be worn by dentists and dental health care workers when spattering of blood or other body fluids is likely.

(D) Waiver - The board may waive the requirements set forth in paragraph (A) of this rule if the board determines that such waiver is justified based on medical documentation indicating that such immunization threatens their health and well being. Any board-approved waiver must be renewed according to the discretion of the board.

Effective: 05/22/2009
R.C. 119.032 review dates: 03/04/2009 and 03/01/2014
Promulgated Under: 119.03
Statutory Authority: 4715.03
Rule Amplifies: 4715.30
Prior Effective Dates: 11-1-87, 7-25-93, 4-7-00, 4-7-05

4715-20-02 Sterilization and disinfection.

(A) Heat sterilization:

(1) Sterilization must be accomplished by an FDA-approved device or method, for example, autoclave, dry heat, or unsaturated chemical vapor.

(2) All high speed and surgical handpieces, low speed contra angles, prophy angles, and nose cones must be thoroughly cleaned prior to being subjected to heat sterilization between patients. Sterilization must be accomplished by an FDA-approved device or method.

(3) All instruments and all items that are able to withstand repeated exposure to heat must be thoroughly cleaned prior to being subjected to heat sterilization between patients. The following instruments and items (but not limited to) must be heat sterilized between patients:

(a) All hand and orthodontic instruments;

(b) All burs and bur changers, including contaminated laboratory burs and diamond abrasives;

(c) All endodontic instruments;

(d) Air-water syringe tips;

(e) High-volume evacuator tips;

(f) Surgical instruments;

(g) Ultrasonic periodontal scalers and tips; and

(h) Electro-surgery tips;

(i) Metal impression trays; and

(j) Intra-oral radiographic equipment that can withstand heat sterilization.

(4) All heat sterilizing devices must be tested for proper function on a weekly basis by means of a biological monitoring system that indicates microorganism kill. The biological monitoring system used must include a control to verify proper microbial incubation. In the event of a positive biological spore test, the dentist must take immediate remedial action to ensure that heat sterilization is being accomplished.

(5) Biological monitoring documentation:

(a) In-office testing documentation - Documentation must be maintained in the form of a log reflecting dates, person(s) conducting the testing, and the results of the test capsule and control capsule.

(b) Independent testing documentation - Reports from the independent testing entity shall be used.

(c) Documentation of testing and repairs shall be maintained for a period of at least two years, and shall be maintained in the dental facility and be made immediately available upon request by an authorized agent of the state dental board.

(B) Chemical sterilization:

Instruments and items that cannot withstand heat sterilization must be subjected to a chemical sterilization process between patients, which is defined as use of a sterilant cleared by the FDA in a 510(k) in accordance with the manufacturer's instructions.

(C) Surface disinfection:

(1) Environmental surfaces that are contaminated by blood or saliva must be properly cleaned prior to disinfection. Disinfection must be accomplished with an appropriate disinfectant that is registered with the environmental protection agency and used in accordance with the manufacturer's instructions. The disinfection process must be followed between each patient.

(2) Impervious backed paper, aluminum foil or plastic wrap must be used to cover surfaces or items that may be contaminated by blood or saliva and that are difficult or impossible to disinfect. The cover must be removed, discarded and then replaced between patients.

(D) Single use items:

All single use or disposable items, labeled as such, used in patient treatment, or have come in contact with blood or saliva, must be discarded and not reused. Single use items include but are not limited to:

(1) Disposable needles and syringes;

(2) Local anesthetic carpules;

(3) Saliva ejectors, high volume evacuator tips, and air water syringe tips;

(4) Prophy angles, cups, and brushes;

(5) Polishing discs, cups, points;

(6) Fluoride trays; and

(7) Disposable impression trays.

(E) Dental laboratory items:

All items that have been placed in the mouth, or are otherwise contaminated with blood or saliva, must be thoroughly rinsed, placed in, and transported to the dental laboratory in an appropriate case containment device that is properly sealed and labeled.

Effective: 05/05/2014
R.C. 119.032 review dates: 02/14/2014 and 04/01/2019
Promulgated Under: 119.03
Statutory Authority: 4715.03
Rule Amplifies: 4715.03
Prior Effective Dates: 11-1-87, 7-25-93, 3-3-95, 4-7-00, 5-15-03, 5-22-09, 4/2/10

4715-20-03 Disposal of sharps.

All sharps items must be disposed of in containers specifically designed and manufactured for the management and/or disposal of sharps in accordance with the requirements established by local and state environmental agencies.

Effective: 04/02/2010
R.C. 119.032 review dates: 12/29/2009 and 01/30/2015
Promulgated Under: 119.03
Statutory Authority: 4715.03
Rule Amplifies: 4715.03 , 4715.30
Prior Effective Dates: 11/1/1987, 4/7/2000