The purpose of this rule is to establish and modify the requirements for administering the office facilities and equipment required for safe and effective administration and the applicable standards of care, in addition to providing for reporting of adverse occurrences related to anesthesia administration.
These requirements are part of a recent attempt by state licensing boards to regulate “oral conscious sedation." Oral conscious sedation drugs are being marketed to dentists for the purpose of managing patient anxiety surrounding dental work in patients that remain conscious throughout the procedure. There are inherent risks to public health and safety that must be managed.
SECTIONS 1, 2, 3, 4, 5, 6 and 7 add new definitions for “anxiolysis," various levels of sedation, types of sedation, routes of sedation and sedation levels; and amends definitions of “local anesthesia," “conscious sedation" and “direct supervision."
SECTION 8 establishes and modifies requirements for administering levels 1 and 2 nitrous oxide or oxygen inhalation analgesia, level 3 enteral conscious sedation, level 3 parenteral sedation, and levels 4 and 5 deep sedation and general anesthesia. It further establishes the requirements for conforming the office facilities and equipment required for safe and effective administration and the applicable standards of care, e.g. emergency preparedness, in addition to providing for reporting of adverse occurrences related to anesthesia administration. In addition to the supervision levels set forth in this section, a permit requirement is added. Finally, the section adds a reporting requirement for dentists for any mortality or other incident resulting in any physical or mental injury that requires hospitalization if that event occurred as a result of anesthesia administration regulated by this chapter.
SECTION 9 repeals ss. DE 11. 11 and 11.12.
A comparison with any existing or proposed federal regulation:
No proposed or existing federal regulation intended to address oral conscious sedation currently exists.
A comparison of similar rules in adjacent states:
Illinois
The Illinois Dental Practice Act contains specific provisions governing anesthesia. Permits are required for the administration of conscious sedation. Dentists are required to have specialized training and office facilities must contain certain equipment Adverse occurrences are also required to be reported. Permits must be renewed biennially. Additional information is available at the Illinois website:
http://www.ildpr.com/WHO/ARpropsd/WEBdentrules.pdf
Indiana
The Indiana State Board of Dentistry requires dentists to obtain a permit prior to administering general anesthesia, deep sedation, or light parenteral conscious sedation. Education and training are required to obtain such permits. Permits must be renewed biennially. Five hours of continuing education are required for permit renewal. Certain emergency equipment is also required. Additional information is available at Indiana's website:
http://www.ai.org/legislative/iac/T08280/A00030.PDF
Iowa
The Iowa Board of Dental Examiners requires a permit for the administration of deep sedation, general anesthesia, and conscious sedation. Dentists are required to have specialized training and office facilities must contain certain equipment. Adverse occurrences are also required to be reported Six hours of continuing education are required for permit renewals. Additional information is available at Iowa's website:
http://www.legis.state.ia.us/Rules/Current/iac/650iac/65029/65029.pdf
Michigan
Minnesota
The Minnesota Board of Dentistry has rules governing general anesthesia and conscious sedation. Education and training are required for both. However, no special permit is issued. Additional information is available at Minnesota's website:
http://www.revisor.leg.state.mn.us/arule/3100/3600.html
To view the proposed rule and submit written comments via e-mail/internet, you may visit the following website:
Fiscal Estimate
The Department of Regulation and Licensing has determined that this rule has no significant fiscal effect on the private sector.
Initial Regulatory Flexibility Analysis
These proposed rules will have no significant economic impact on a substantial number of small businesses, as defined in s.
227.114 (1) (a), Stats
Copies of Rule and Contact Person
Copies of this proposed rule are available without cost upon request to: Pamela Haack, Department of Regulation and Licensing, Office of Administrative Rules, 1400 East Washington Avenue, Room 171, P.O. Box 8935, Madison, Wisconsin 53708 (608) 266-0495
Notice of Hearings
Health and Family Services
NOTICE IS HEREBY GIVEN that pursuant to ss. ss.
254.71 (6) and
254.74 (1), Stats., and interpreting ss.
254.61 to
254.62,
254.64 to
254.72,
254.74 and
254.85, Stats., the Department of Health and Family Services will hold public hearings to consider the proposed permanent rules amending HFS 196.04 (1) (b), (2) (b) 4., Table HFS 196.04, 196.05 (2) (a) and (b), 196.07 and Appendix; and creating HFS 196.03 (1g), (1r) and (3m) and 196.04 (1) (d) and (e), relating to restaurants and affecting small businesses.
Hearing Information
The public is invited to attend the hearing at the time and locations listed below. Comments will be heard by interactive videoconferencing from each of the listed sites.
Thursday October 7, 2004, 9:30 a.m. to 12:30 p.m.
Main Broadcast Center
Madison
UW Pyle Center
Room 227
702 Langdon Street
Madison, WI 53706
Waukesha
Waukesha State Office Building
Department of Transportation Offices
Room 153
141 NW Barstow St.
Waukesha, WI 53188
Appleton
Fox Valley Technical College
Room G1131
1825 Bluemound Dr
Appleton, WI 54913-2277
Wisconsin Rapids
Dept of Transportation
Room 120
1681 2nd Ave S
PO Box 8021
Wisconsin Rapids, WI 54495-8021
Eau Claire
Eau Claire State Office Building
Room 139
718 W. Clairemont Ave
Eau Claire, WI 54702
Spooner
WI DNR Northern Region Office
Conference Room
810 West Maple St.
Spooner, WI 54801
The hearing sites are fully accessible to people with disabilities. If you are hearing or visually impaired, do not speak English, or have circumstances that might make communication at a hearing difficult and if you, therefore, require an interpreter or a non-English, large print or taped version of the hearing document, contact the person at the address or phone number given above at least 10 days before the hearing. With less than 10 days notice, an interpreter may not be available.
Written comments may be submitted at the public hearing or in lieu of attending a public hearing, written comments can be submitted by regular mail or email to the contact person listed below. Written comments may also be submitted to the Department using the Wisconsin Administrative Rules Internet website at the web address listed below.
Deadline for Comment Submission
The deadline for submitting comments is 4:30 p.m., on October 22, 2004.
Analysis Prepared by the Department of Health and Family Services
This order proposes revising ch.
HFS 196, relating to restaurants, including its Appendix, known as the Wisconsin Food Code. The operator of every restaurant in the state must have a permit from the Department of Health and Family Services or an agent local health department before the restaurant may open for business and the restaurant must maintain its permit in order for it to continue operating. The permit signifies that the restaurant complies with the requirements in ch.
HFS 196, which is intended to protect public health and safety. The requirements of this chapter are enforced either by the Department or a local health department that the Department has designated as the Department's agent.
The Department's current rules for restaurants were established in 1985 and most recently revised in 2001. Through sections one to six of this order, the Department is proposing to make the following revisions in HFS 196:
•change the term “limited term restaurant" to “pre-packaged restaurant;"
•define the terms “caterer," “contract cook" and “pre-packaged restaurant;"
•modify table HFS 196.04 to eliminate reference to the term “limited;"
•clarify that caterers operating from their permitted restaurants need not obtain additional permits for locations where the caterer serves food; and
•specify operating conditions under which contract cooks are not required to obtain restaurant permits.
Section seven of this order pertains to the Wisconsin Food Code Appendix to HFS 196 and contains the bulk of the proposed changes. The existing Wisconsin Food Code is modeled after the 1999 Food and Drug Administration (FDA) Model Food Code, which contains model requirements for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. Over 44 U.S. states and territories have adopted some version of the FDA Model Food Code and 9 states or territories are in the rulemaking process to adopt the FDA Model Food Code. The Department, which regulates Wisconsin restaurants under ch.
HFS 196, and the Department of Agriculture, Trade, and Consumer Protection (DATCP), which licenses and inspects retail food establishments, such as grocery stores under ch.
ATCP 75, jointly adopted the Wisconsin Food Code in 2001 for their respective regulatory activities. A common Wisconsin Food Code for restaurants and retail food establishments ensures that the same rules will apply to all types of food establishments, including combinations. Although DATCP and DHFS (or their local agents) coordinate their activities so that a combined grocery store and restaurant is regulated by DATCP or DHFS, but not both, joint adoption and updating of the Wisconsin Food Code is still important for consistent regulation.
The FDA revised its Model Food Code in 2001. The Department proposes to update the Wisconsin Food Code to the 2001 FDA Model Food Code, which reflects the most currently available science and trends in food safety. In addition, the Department proposes to clarify or correct areas of the Wisconsin Food Code that do not reflect current Department policy. Revisions to the Wisconsin Food Code will also reflect modifications from both the Wisconsin Conference on Food Protection and the National Conference on Food Protection, as well as mutually agreed upon suggestions derived from two years of field application by both the Department and DATCP.
