TITLE examining-boards

Part V. State Board of Dental Examiners

Chapter 109. Conduct

Subchapter L. Anesthesia and Anesthetic Agents

22 TAC §109.171

The State Board of Dental Examiners proposes amendments to §109.171, concerning the effective date of §109.171, §109.172, §109.173, §109.174, and §109.175.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that the proposed amendment to §109.171 clarifies the effective dates amended rules affecting anesthesia procedures.

There will be no effect on small and large businesses and on persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17, 1999.

The amended rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act.

The proposed amended rule does not affect other statutes, articles, or codes.

§109.171.Effective Date.

Unless specifically provided otherwise, the provisions of rules 109.172, 109.173, 109.174, and 109.175 of this title (relating to Anesthesia and Anesthetic Agents) that require equipment and/or certifications not required by those rules that were in effect on September 1, 1998, shall not be enforced until September 1, 2000. All other provisions of subchapter L of this chapter, as amended become effective as provided by law. [ The effective date of these sections shall be July 1, 1988. ]

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902004

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


22 TAC §109.172

The State Board of Dental Examiners proposes amendments to §109.172, concerning definitions.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that §109.172 clarifies certain definitions relative to administration of anesthesia.

There will be no effect on small and large businesses and on persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17, 1999.

The amended rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act.

The proposed amended rule does not affect other statutes, articles, or codes.

§109.172.Definitions.

The following words and terms, when used in subchapter L, Anesthesia and Anesthetic Agents [ this chapter ], shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Analgesia - the diminution or elimination of pain [ or production of increased tolerance to pain in the conscious patient ].

(2)

Competent - displaying special skill or knowledge derived from training and experience.

(3)

[ (8) ] [ Parenteral ] Conscious Sedation - a minimally depressed level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal command, and that is produced by a pharmacologic or non-pharmacologic method, or a combination thereof. In accord with this particular definition, the drugs and/or techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely. Further, patients whose only response is reflex withdrawal from repeated painful stimuli would not be considered to be in a state of conscious sedation.

(4)

Continual - repeated regularly and frequently in a steady succession.

(5)

Continuous - prolonged without any interruption at any time.

(6)

[ (9) ] [ Parenteral ] Deep Sedation - an induced [ A Controlled ] state of depressed consciousness accompanied by partial loss of protective reflexes, including the inability to continually maintain an airway independently and/or respond purposefully to verbal command, and is produced by a pharmacological or non-pharmacological method, or a combination thereof.

(7)

[ (2) ] Direct supervision - the dentist responsible for the sedation/anesthesia procedure shall be physically present in the office and shall be continuously aware of the patient's physical status and well being.

(8)

Enteral - any technique of administration in which the agent is absorbed through the gastrointestinal (GI) tract or oral mucosa (i.e., oral, rectal, sublingual) .

(9)

Facility - the primary office where a permit holder practices dentistry and provides anesthesia services.

(10)

Facility inspection - an on-site inspection to determine if a facility is supplied, equipped, staffed, and maintained in a condition to support provision of anesthesia services that meet the minimum standard of care; may be required by the State Board of Dental Examiners prior to the issuance of a sedation/anesthesia permit or any time during the term of the permit if the holder of or applicant for a permit owns or operates a primary facility or satellite facility.

(11)

[ (3) ] General anesthesia - an induced [ A controlled ] state of unconsciousness accompanied by partial or complete loss of protective reflexes, including inability to independently maintain an airway and respond purposefully to physical stimulation or [ to ] verbal command, and is produced by a pharmacological or non-pharmacological method or a combination thereof.

(12)

Immediately available - on-site in the facility and available for immediate use.

(13)

Inhalation - a technique of administration in which a gaseous or volatile agent is introduced into the pulmonary tree and whose primary effect is due to absorption through the pulmonary bed (e.g. nitrous oxide/oxygen sedation).

(14)

[ (4) ] Local anesthesia - the elimination of sensations, especially pain, in one part of the body by the [ topical application or ] regional injection of a drug.

(15)

[ (5) ] May [ or could ] - indicates freedom or liberty to follow a reasonable [ suggested ] alternative.

(16)

[ (6) ] Must or shall - indicates an imperative need and/or duty; an essential or indispensable item; mandatory.

(17)

[ (7) ] Nitrous Oxide/oxygen inhalation conscious sedation - the administration by inhalation of a combination of nitrous oxide and oxygen producing an altered level of consciousness that retains the patient's ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and/or verbal command.

(18)

Parenteral - a technique of administration in which the drug bypasses the gastrointestinal (GI) tract, i.e., intramuscular (IM), intravenous (IV), intranasal (IN), submucosal (SM), subcutaneous (SC).

(19)

Patient Physical Status Classification:

(A)

ASA - American Society of Anesthesiologists

(B)

ASA I - a normal health patient

(C)

ASA II - a patient with mild systemic disease

(D)

ASA III - a patient with severe systemic disease

(E)

ASA IV - a patient with severe systemic disease that is a constant threat to life

(F)

ASA V - a moribund patient who is not expected to survive without the operation

(G)

ASA VI - a declared brain-dead patient whose organs are being removed for donor purposes

(H)

E - emergency operation of any variety (used to modify the ASA I - ASA VI).

(20)

[ (10) ] Personal supervision - the provider [ dentist ] responsible for the sedation/ anesthesia procedure shall be physically present in the room with the patient at all times during the induction and maintenance of the procedure.

(21)

Portability - the ability of a permit holder to provide permitted anesthesia services in a location other than a facility or satellite facility.

(22)

Satellite facility - an additional office or offices owned or operated by the permit holder, or owned or operated by a professional organization through which the permit holder practices dentistry, or a licensed hospital facility.

(23)

[ (11) ] Should - indicates the recommended manner to obtain the standard; highly desirable.

(24)

Time-oriented anesthesia record - documentation at appropriate intervals of drugs, doses and physiologic data obtained during patient monitoring.

(25)

Topical Anesthesia - the elimination of sensations, especially pain, in one part of the body by the topical application of a drug.

(26)

Transdermal/transmucosal - a technique of administration in which the drug is administered by patch or iontophoresis.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902005

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


22 TAC §109.173

The State Board of Dental Examiners proposes amendments to §109.173, concerning minimum standard of care.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that §109.173 communicates unambiguously that practicing dentists must follow generally accepted protocols and/or standards of care for management of complications and emergencies and informed consent will be required only where there is a reasonable probability of complications from a procedure.

There will be no effect on small and large businesses and on persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17,1999.

The amended rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act.

The proposed amended rule does not affect other statutes, articles, or codes.

§109.173.Minimum Standard of Care.

Each dentist licensed by the [ Texas ] State Board of Dental Examiners and practicing in Texas shall conduct his/her [ their ] practice in a manner consistent with that of a reasonable and prudent dentist under the same or similar circumstances. Further, each dentist:

(1)

(No change.)

(2)

Shall maintain and review an initial medical history and perform limited physical evaluation for all dental patients to wit:

(A)

(No change.)

(B)

The initial limited physical examination should [ shall ] include, but shall not necessarily be limited to, blood pressure and pulse/heart rate as may be indicated for each patient.

(3)

(No change.)

(4)

Shall, for office emergencies:

(A)-(B)

(No change.)

(C)

provide training to dental office personnel in emergency procedures which shall include, but not necessarily be limited to, basic cardiac life support, inspection and utilization of emergency equipment in the dental office, and office procedures to be followed in the event of an emergency as determined by a reasonable and prudent dentist in the same or similar circumstances; and

(D)

shall adhere to generally accepted protocols and/or standards of care for management of complications and emergencies.

(5)

Shall sucessfully complete a current course in basic cardiopulmonary resuscitation [ every two years ] offered by either the American Heart Association or the American Red Cross.

(6)

Should maintain a written informed consent for all procedures where a reasonable possibility of complications from the procedure exists, and such consent should disclose risks or hazards that could influence a reasonable person in making a decision to give or withhold consent. [ Shall obtain an informed consent in all situations where required by law. ]

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902006

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


22 TAC §109.174

The State Board of Dental Examiners proposes amendments to §109.174, concerning sedation, anesthesia permits.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that §109.174 will assure that the overall quality of anesthesia procedures meets the standard of care.

The effect on small businesses that are required to comply with the rule as proposed shall be their staffs remain qualified to meet the standard of care for anesthesia procedures or such businesses shall not be authorized by the State Board of Dental Examiners to perform anesthesia procedures. The fiscal impact on small businesses required to comply with the rule as proposed will be contingent upon each business' cost of permits and staff training for the anesthesia procedure authorized by the State Board of Dental Examiners and concomitant costs associated with each permitted procedure, e.g., equipment and staff. Such costs assure a minimum quality of care that is reasonable for the public safety. These costs, however, are not so negative as to impact the economic viability of a small business. Therefore, the State Board of Dental Examiners has determined that compliance with the proposed rule will not have an adverse economic impact on small businesses as the cost of compliance will be minimal.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17,1999.

The amended rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act.

The proposed amended rule does not affect other statutes, articles, or codes.

§109.174.Sedation/Anesthesia Permit.

(a)

The [ Texas ] State Board of Dental Examiners shall appoint advisory consultants for advice and recommendations to the Board on permit requirements, applicant and facility approval.

(b)

[ From the effective date of these sections, each ] A dentist licensed by the [ Texas ] State Board of Dental Examiners and practicing in Texas, who desires to utilize nitrous oxide/oxygen inhalation conscious sedation, parenteral conscious sedation, and/or parenteral deep sedation and general anesthesia, must obtain a permit [ of authorization ] from the [ Texas ] State Board of Dental Examiners for the requested procedure.

(1)

A permit may be obtained by completing an application form approved by the State Board of Dental Examiners, a copy of which may be obtained from the SBDE.

(2)

The application form must be filled out completely and appropriate fees paid.

(3)

Prior to issuance of a sedation/anesthesia permit the Board may require that the applicant undergo a facility inspection or further review of anesthesia credentials. The SBDE may direct an Anesthesia Consultant, who has been appointed by the Board, to assist in this inspection or review. The applicant will be notified in writing if an inspection is required and provided with the name of an Anesthesia Consultant who will coordinate the inspection. The applicant must make arrangements for completion of the inspection within 180 days of the date the notice is mailed. An extension of no more than 90 days may be granted if the designated Anesthesia Consultant requests one.

(4)

An applicant for a sedation/anesthesia permit must be licensed and in good standing with the State Board of Dental Examiners. For purposes of Rules 109.171 through 109.175, of this title (relating to Anesthesia and Anesthetic Agents) "good standing" means that a licensee is not suspended, whether or not the suspension is probated. Applications from licensees who are not in good standing will not be approved.

(c)

Any dentist approved by the [ Texas ] State Board of Dental Examiners under previous rules prior to the effective date of this section for the utilization of nitrous oxide/oxygen inhalation conscious sedation, parenteral conscious sedation, or parenteral deep sedation/general anesthesia, except as described in subsection (d) of this section, shall remain permitted provided that the appropriate fees have been paid and that the dentist has a current license. [ or general anesthesia may qualify for a new permit. ]

(d)

Once a permit is issued, the State Board of Dental Examiners upon payment of required fees shall automatically renew the permit annually unless after notice and opportunity for hearing the Board finds the permit holder has, or is likely to provide anesthesia services in a manner that does not meet the minimum standard of care. At such hearing the Board shall consider factors including patient complaints, morbidity, mortality, and anesthesia consultant recommendations. [ Each holder of an existing permit shall be required to complete and submit a new application for the procedure(s) desired within one year from the effective date of these sections to the Texas State Board of Dental Examiners. If the new permit application is not received within this designated period, the prior permit shall be canceled. Each new application shall be reviewed to determine if the permit holder meets the "standard of care" requirements for the permit requested. If the requirements are met, a new permit shall be issued. If the requirements are not met, the permit applicant shall be notified and provided an appropriate period, at the discretion of the Board, to correct the deficiency. ]

(e)

Annual dental license renewal certificates shall include the annual permit renewal, except as provided for in subsection (d) of this section and shall be assessed an annual renewal fee of $5.00 payable with the license renewal. New permit fees are $28.75 payable with the application for permit. [ For new applicants who are otherwise properly qualified, a temporary provisional permit may be issued for one year by the Board, based solely upon the credentials contained in the application. ]

(f)

Permit Restrictions: [ Prior to or after the issuance of any permit, the Texas State Board of Dental Examiners may, at its discretion, require an on-site office evaluation to determine if all standards of these sections are being met. ]

(1)

A sedation/anesthesia permit is valid for the dentist's facility, if any, as well as any satellite facility.

(2)

Portability of a sedation/anesthesia permit will be granted to a dentist who, after September 1, 2000, applies for portability if the dentist is granted:

(A)

a deep sedation/general anesthesia permit; or

(B)

an intravenous parenteral conscious sedation permit if training for the permit was obtained on the basis of completion of

(i)

a specialty program approved by the Commission on Dental Accreditation of the American Dental Association, or

(ii)

a general practice residency, approved by the Commission on Dental Accreditation of the American Dental Association, or

(iii)

an advanced education in general dentistry program, approved by the Commission on Dental Accreditation of the American Dental Association, or

(iv)

a Continuing Education (CE) program specifically approved by the SBDE. The board may approve a graduate of a CE program under this subsection only if the applicant can demonstrate administration of intravenous parenteral conscious sedation in at least 30 cases that are documented showing provision of anesthesia services in keeping with the standard of care as determined by one or more of the SBDE's anesthesia consultants; and the applicant establishes that the program consisted of

(I)

sixty hours of didactic courses;

(II)

administration of intravenous parenteral conscious sedation in at least 20 cases where the applicant was the anesthesia provider.

(3)

When anesthesia services are provided by a dentist at a location other than a facility or a satellite facility, the dentist shall strictly adhere to all rules of the State Board of Dental Examiners which may apply. The dentist shall ascertain that the location is supplied, equipped, staffed and maintained in a condition to support provision of anesthesia services that meet the standard of care.

(4)

A dentist holding a permit to administer parenteral conscious sedation on the effective date of this rule who is qualified by training or experience to administer intravenous parenteral conscious sedation anesthesia on a portable basis, and who desires to do so must file with the State Board of Dental Examiners proof of completion of:

(A)

a specialty program approved by the Commission on Dental Accreditation of the American Dental Association, or

(B)

a general practice residency approved by the Commission on Dental Accreditation of the American Dental Association, or

(C)

an advanced education in a general dentistry program approved by the Commission on Dental Accreditation of the American Dental Association, or

(D)

a Continuing Education program and administration of intravenous parenteral conscious sedation in at least 30 cases that are documented showing provision of anesthesia services in keeping with the standard of care as determined by one or more of the SBDE's anesthesia consultants.

(E)

The records of all dentists permitted to administer parenteral conscious sedation will be annotated showing whether portability status is granted.

(F)

Any applicant whose request for portability is not granted on the basis of the application will be provided an opportunity for hearing pursuant to Texas Government Code, Section 2001 et.seq.

(5)

A dentist holding a permit to administer parenteral deep sedation/general anesthesia on the effective date of this rule who desires to provide anesthesia on a portable basis must file with the State Board of Dental Examiners a request for a portability designation.

(A)

The records of all dentists permitted to administer parenteral deep sedation/general anesthesia will be annotated showing whether portability status is granted.

(B)

Any applicant whose request for portability status is not granted on the basis of the application will be provided an opportunity for hearing pursuant to Texas Government Code, Section 2001 et.seq.

(6)

The Board may elect to issue a temporary sedation/anesthesia permit which will expire on a date certain. A full sedation/anesthesia permit may be issued after the dentist has complied with requests of the Board which may include, but shall not be limited to, review of the dentist's anesthetic technique, facility inspection and/or review of patient records to ascertain that the minimum standard of care is being met. If a full permit is not issued, the temporary permit will expire on the stated date, and no further action by the State Board of Dental Examiners will be required, and no hearing will be conducted.

(g)

Educational/Professional requirements for sedation/anesthesia permits: [ Once a permit is issued, the Texas State Board of Dental Examiners shall automatically renew the permit annually unless the holder of said permit is informed by the Board that an evaluation of the permit is required. Prior to an evaluation of an existing permit, the Board shall consider factors to include patient complaints, morbidity, mortality, and advisory consultant recommendations. ]

(1)

Nitrous Oxide/Oxygen Inhalation Conscious Sedation

(A)

To administer nitrous oxide/oxygen inhalation conscious sedation, the dentist must satisfy one of the following criteria:

(i)

must have completed training consistent with that described in Part I or Part III of the American Dental Association (ADA) Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry; or

(ii)

must have completed an ADA accredited post-doctoral training program which affords comprehensive and appropriate training necessary to administer and manage nitrous oxide/oxygen inhalation conscious sedation.

(B)

The following shall apply to the administration of nitrous oxide/oxygen inhalation conscious sedation in the dental office:

(i)

provision of nitrous oxide/oxygen inhalation conscious sedation by another duly qualified dentist or physician anesthesiologist requires the operating dentist and his/her clinical staff to maintain current expertise in Basic Life Support (BLS);

(ii)

when a Certified Registered Nurse Anesthetist (CRNA) is permitted to function under the supervision of a dentist, in the dental office, provision of nitrous oxide/oxygen inhalation conscious sedation by a CRNA shall require the operating dentist to have completed training in nitrous oxide/oxygen inhalation conscious sedation, and to be permitted for its utilization.

(2)

Parenteral Conscious Sedation

(A)

To administer parenteral conscious sedation, the dentist must satisfy one of the following criteria:

(i)

completion of a comprehensive training program in parenteral conscious sedation that satisfies the requirement described in Part III of the American Dental Association (ADA) Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry at the time training was commenced; or

(ii)

completion of an ADA accredited post-doctoral training program which affords comprehensive and appropriate training necessary to administer and manage parenteral conscious sedation.

(B)

The following shall apply to the administration of parenteral conscious sedation in the dental office:

(i)

provision of parenteral conscious sedation by another duly qualified dentist or physician anesthesiologist requires the operating dentist and his/her clinical staff to maintain current expertise in Basic Life Support (BLS);

(ii)

when a Certified Registered Nurse Anesthetist (CRNA) is permitted to function under the supervision of a dentist, in the dental office, provision of parenteral conscious sedation by a CRNA shall require the operating dentist to have completed training in parenteral conscious sedation, and to be permitted for its utilization;

(iii)

a dentist administering parenteral conscious sedation must document current, successful completion every three years of an advanced emergency procedures course approved by the State Board of Dental Examiners or an Advanced Cardiac Life Support (ACLS) course, or a Pediatric Advanced Life Support (PALS) or age appropriate equivalent course.

(3)

Parenteral Deep Sedation/General Anesthesia

(A)

To administer parenteral deep sedation/general anesthesia, the dentist must satisfy one of the following criteria:

(i)

completion of an advanced training program in anesthesia and related subjects beyond the undergraduate dental curriculum that satisfies the requirements described in Part II of the American Dental Association (ADA) Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry at the time training was commenced; or,

(ii)

completion of an ADA accredited post-doctoral training program which affords comprehensive and appropriate training necessary to administer and manage parenteral deep sedation/general anesthesia.

(B)

The following shall apply to the administration of parenteral deep sedation/general anesthesia in the dental office:

(i)

provision of parenteral deep sedation/general anesthesia by another duly qualified dentist or physician anesthesiologist requires the operating dentist and his/her clinical staff to maintain current expertise in Basic Life Support (BLS);

(ii)

when a Certified Registered Nurse Anesthetist (CRNA) is permitted to function under the supervision of a dentist, in the dental office, provision of parenteral deep sedation/general anesthesia by a CRNA shall require the operating dentist to have completed training in parenteral deep sedation/general anesthesia, and to be permitted for its utilization;

(iii)

a dentist administering parenteral deep sedation/general anesthesia must document current, successful completion every three years of an advanced emergency procedures course approved by the State Board of Dental Examiners or an Advanced Cardiac Life Support (ACLS) course, or a Pediatric Advanced Life Support (PALS) or age appropriate equivalent course.

[ (h)

Annual dental license renewal certificates shall include the annual permit renewal, except as provided for in (g) above, and shall be assessed an annual renewal fee of $5.00 payable with the license renewal beginning March 1 and thereafter. New permit issuances will be charged a $25.00 fee, payable with the application for permit, beginning March 1, 1992. ]

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902007

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


22 TAC §109.175

The State Board of Dental Examiners proposes amendments to §109.175, concerning permit requirements and clinical provisions.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that §109.175 will assure that the overall quality of anesthesia procedures meets the standard of care.

The effect on small businesses that are required to comply with the rule as proposed shall be their staffs remain qualified to meet the standard of care for anesthesia procedures or such businesses shall not be authorized by the State Board of Dental Examiners to perform anesthesia procedures. The fiscal impact on small businesses required to comply with the rule as proposed will be contingent upon each business' cost of permits and staff training for the anesthesia procedure authorized by the State Board of Dental Examiners and concomitant costs associated with each permitted procedure, e.g., equipment and staff. Such costs assure a minimum quality of care that is reasonable for the public safety. These costs, however, are not so negative as to impact the economic viability of a small business. Therefore, the State Board of Dental Examiners has determined that compliance with the proposed rule will not have an adverse economic impact on small businesses as the cost of compliance will be minimal.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17, 1999.

The amended rule is proposed under Texas Government Code §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act.

The proposed amended rule does not affect other statutes, articles, or codes.

§109.175. Permit Requirements and Clinical Provisions .

(a)

Nitrous Oxide/oxygen inhalation conscious sedation. To induce and maintain this type of conscious sedation on patients having dental/oral and maxillofacial surgical procedures in the State of Texas, the following requirements must be met:

(1)

Professional requirements.

(A)

Each dentist wishing to utilize this technique must be permitted by the State Board of Dental Examiners (SBDE) to deliver nitrous oxide/oxygen conscious sedation after having met the Education Requirements as detailed in rule 109.174 (g)(1) of this title (relating to Sedation/Anesthesia Permit). [ Each dentist wishing to utilize this technique must produce satisfactory evidence of completion of a didactic and clinical course of instruction in this technique. Such courses of instruction shall: ]

[ (i)

be directed by qualified instructors with advanced education in comprehensive pain control and with broad clinical experience in this technique; ]

[ (ii)

include a minimum of four hours of didactic work in pharmacodynamics of nitrous oxide/oxygen inhalation conscious sedation; ]

[ (iii)

include a minimum of six hours of clinical experience under personal supervision. ]

(B)

Nitrous oxide/oxygen inhalation conscious sedation shall be induced and maintained by a dentist licensed by the State of Texas and practicing in Texas, a physician anesthesiologist licensed by the Texas State Board of Medical Examiners, or a Certified Registered Nurse Anesthetist (CRNA) licensed in Texas. [ Each dentist must produce satisfactory evidence of completion of a continuing education course in the nitrous oxide oxygen inhalation/ conscious sedation which includes the prevention and management of emergencies in the dental office; or, ]

[ (C)

Each dentist must have successfully completed qualifications governing the use of parenteral conscious sedation as noted in subsection (b) of this section or deep sedation/general anesthesia as noted in subsection (c) of this section. ]

(2)

Standard of care requirements. Each dentist must maintain the minimum standard of care as detailed in rule 109.173 of this title (relating to Minimum Standard of Care), and shall in addition:

(A)

adhere to the clinical requirements as detailed in paragraph (3) of this subsection; [ Each dentist must maintain the minimum standard of care as noted in 109.173 of this title (relating to Minimum Standard of Care). ]

(B)

maintain under continuous direct supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of nitrous oxide/oxygen inhalation conscious sedation. [ Each dentist shall induce, monitor, and provide continuous personal supervision of the inhalation conscious sedation procedure, or the dentist shall induce and may delegate under direct supervision, as defined in Rule 109.172, the monitoring of the nitrous oxide inhalation conscious sedation procedure to a dental auxiliary who has been certified by the Board. Certification is obtained by successful completion of a written examination offered by the Board on said subject. ]

(C)

maintain current certification in basic cardiopulmonary resuscitation for the assistant staff by having them pass a course sponsored by the American Heart Association or the American Red Cross; and

(D)

not allow a nitrous oxide/oxygen inhalation conscious sedation procedure to be performed in his/her office by a Certified Registered Nurse Anesthetist (CRNA) unless the dentist holds a permit issued by the State Board of Dental Examiners for the procedure being performed.

(3)

Clinical Requirements. Each dentist must meet the following clinical requirements for utilization of nitrous oxide/oxygen inhalation conscious sedation:

(A)

Patient Evaluation. Patients subjected to nitrous oxide/oxygen inhalation conscious sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II), this may be simply a review of their current medical history and medication use. However, with individuals who may not be medically stable or who have a significant health disability (ASA III, IV) consultation with their primary care physician or consulting medical specialist regarding potential procedure risk should be considered.

(B)

Pre-Procedure preparation, informed consent:

(i)

the patient and/or guardian must be advised of the procedure associated with the delivery of the nitrous oxide/oxygen inhalation conscious sedation.

(ii)

the inhalation equipment must be evaluated for proper operation and delivery of inhalation agents prior to use on each patient;

(iii)

determination of adequate oxygen supply must be completed prior to use with each patient;

(iv)

baseline vital signs should be obtained at the discretion of the operator depending on the medical status of the patient and the nature of the procedure to be performed.

(C)

Personnel and Equipment Requirements:

(i)

in addition to the dentist, at least one member of the assistant staff should be present during the administration of nitrous oxide/oxygen inhalation conscious sedation in non-emergency situations;

(ii)

the inhalation equipment must have a fail-safe system that is appropriately checked and calibrated;

(iii)

if nitrous oxide and oxygen delivery equipment capable of delivering less than 25% oxygen is used, an in-line oxygen analyzer must be utilized;

(iv)

the equipment must have an appropriate nitrous oxide/oxygen scavenging system.

(v)

regardless of the sedation/anesthesia technique, the ability of the provider and/or the facility to deliver positive pressure oxygen must be maintained.

(D)

Monitoring and Documentation:

(i)

maintain personal supervision of the patient during induction of the nitrous oxide/oxygen inhalation conscious sedation procedure and during maintenance of nitrous oxide/oxygen inhalation conscious sedation for such a period of time necessary to establish pharmacologic and physiologic vital sign stability. The dentist may delegate under direct supervision, as defined in Rule 109.172 of this title (relating to Definitions), the monitoring of the nitrous oxide/oxygen inhalation conscious sedation procedure to a dental auxiliary who has been certified to monitor the administration of nitrous oxide/oxygen inhalation conscious sedation by the State Board of Dental Examiners. Certification is obtained by successful completion of a written examination offered by the State Board of Dental Examiners on said subject.

(ii)

individuals present during administration should be documented;

(iii)

maximum concentration administered must be documented.

(E)

Recovery and Discharge:

(i)

recovery from nitrous oxide/oxygen inhalation conscious sedation, when used alone, should be relatively quick, requiring only that the patient remain in an operatory chair as needed;

(ii)

patients who have unusual reactions to nitrous oxide/oxygen inhalation conscious sedation should be assisted and monitored either in an operatory chair or recovery room until stable for discharge;

(iii)

the dentist must determine that the patient is appropriately responsive prior to discharge.

(F)

Emergency Management. The dentist, personnel and facility must be prepared to treat emergencies that may arise from the administration of nitrous oxide/oxygen inhalation conscious sedation.

(b)

Parenteral conscious sedation (intravenous (IV), intramuscular (IM), subcutaneous (SC), submucosal (SM), intranasal (IN) ). To induce and maintain this type of conscious sedation on patients having dental/oral and maxillofacial surgical procedures in the State of Texas, the following requirements must be met:

(1)

Professional Requirements: [ parenteral conscious sedation shall be induced and maintained by a dentist licensed by the State of Texas and practicing in Texas, a physician anesthesiologist licensed by the Texas State Board of Medical Examiners, or a Certified Registered Nurse Anesthetist licensed in Texas (see paragraph (3) (G) of this subsection). ]

(A)

each dentist wishing to utilize these techniques must be permitted by the State Board of Dental Examiners (SBDE) to deliver parenteral conscious sedation after having met the educational requirements as detailed in Rule 109.174(g)(2) of this title (relating to Sedation/Anesthesia Permit).

(B)

parenteral conscious sedation shall be induced and maintained by a dentist licensed by the State of Texas and practicing in Texas, a physician anesthesiologist licensed by the Texas State Board of Medical Examiners, or a Certified Registered Nurse Anesthetist (CRNA) licensed in Texas.

(2)

Standard of Care Requirements. Each dentist must maintain the minimum standard of care as detailed in Rule 109.173 of this title (relating to the Minimum Standard of Care) and shall in addition: [ Professional requirements are as follows: ]

(A)

adhere to the clinical requirements as detailed in paragraph (3) of this subsection; [ has satisfactorily completed an intensive course that meets the "Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry" published by the American Dental Association Council on Dental Education for the parenteral conscious sedation technique requested; or ]

(B)

maintain a written informed parenteral conscious sedation consent for each dental patient on whom each procedure is performed; such consent shall specify that the risks related to the procedure include cardiac arrest, brain injury and death; [ has satisfactorily completed an approved graduate program by the Commission on Dental Accreditation of the American Dental Association where training to competency in parenteral conscious sedation is a minimum standard required in the training guidelines (oral and maxillofacial surgery, pediatric dentistry, periodontics, and some general practice residencies); or ]

(C)

maintain a time oriented, written anesthetic record which shall record dosages of anesthetic agents utilized and which shall include physiologic vital sign monitoring during the course of the procedure; [ has satisfactorily completed qualifications governing the use of general anesthesia. ]

(D)

maintain under continuous personal supervision auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of parenteral conscious sedation;

(E)

maintain current certification in basic cardiopulmonary resuscitation for the assistant staff by having them pass a course sponsored by the American Heart Association or the American Red Cross.

(F)

not allow a parenteral conscious sedation procedure to be performed in his/her office by a Certified Registered Nurse Anesthetist (CRNA) unless the dentist holds a permit issued by the State Board of Dental Examiners for the procedure being performed.

(3)

Clinical Requirements. Each dentist must meet the following clinical requirements for utilization of parenteral conscious sedation: [ Standard of care requirements. Each dentist shall utilize the following standard of care in addition to the minimum standards noted in section 109.173 of this title (relating to Minimum Standard of Care) for each parenteral conscious sedation procedure: ]

(A)

Patient Evaluation. Patients subjected to parenteral conscious sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II) this may be simply a review of their current medical history and medication use. However, with individuals who may not be medically stable or who have a significant health disability (ASA III, IV) consultation with their primary care physicians or consulting medical specialists regarding potential procedure risk or special monitoring requirements should be considered. [ maintain an informed conscious sedation consent by each dental patient on whom each procedure is performed, which consent shall specify that the risks related to the procedure include brain damage and death; ]

(B)

Pre-procedure preparation, informed consent: [ maintain an adequate written sedation record which shall include physiologic vital sign monitoring during the course of the procedure; ]

(i)

the patient and/or guardian must be advised of the procedure associated with the delivery of any sedative agents and the appropriate informed consent must be obtained;

(ii)

if inhalation equipment is used in conjunction with parenteral conscious sedation, the equipment must be evaluated for proper operation and delivery of inhalation agents prior to use on each patient;

(iii)

determination of adequate oxygen supply must be completed prior to use with each patient;

(iv)

baseline vital signs should be obtained;

(v)

pre-treatment physical evaluation must be performed as deemed appropriate;

(vi)

specific dietary restrictions must be delineated based on the technique used and patient's physical status;

(vii)

appropriate verbal or written instructions regarding the procedure must be given to the patient and/or guardian;

(viii)

an intravenous line must be established and secured throughout a procedure utilizing an intravenous conscious sedation technique and should be maintained with other parenteral conscious sedation techniques when the patient's physical or medical condition warrants, except as provided in subparagraph (F) of this paragraph.

(C)

Personnel Requirements and Equipment: [ maintain continuous direct supervision of the sedation procedure and patient vital sign monitoring during the course of the procedure; ]

(i)

during the administration of parenteral conscious sedation the dentist and at least one member of the assistant staff who is currently competent in Basic Life Support (BLS) must be present;

(ii)

any inhalation equipment utilized in conjunction with parenteral conscious sedation must have a fail safe system that is appropriately checked and calibrated;

(iii)

if nitrous oxide and oxygen delivery equipment capable of delivering less than 25% oxygen is used, an in-line oxygen analyzer must be utilized;

(iv)

the inhalation equipment must have an appropriate nitrous oxide/oxygen scavenging system;

(v)

regardless of the sedation/anesthesia technique, the ability of the provider and/or the facility to deliver positive pressure oxygen must be maintained.

(D)

Monitoring and Documentation. Maintain personal supervision of the patient during the induction of parenteral conscious sedation and during maintenance of parenteral conscious sedation for a period of time necessary to establish pharmacologic and physiologic vital sign stability. When a Certified Registered Nurse Anesthetist (CRNA) provides the parenteral conscious sedation care, he/she shall be under the direct supervision of the dentist in the dental office. Delegation of personal supervision may occur if a second dentist or physician anesthesiologist is delivering the anesthesia care. [ maintain current certification in basic cardiopulmonary resuscitation for the assistant staff by having them pass a course sponsored by the American Heart Association or the American Red Cross; ]

(i)

Oxygenation. Color of mucosa, skin or blood shall be continually evaluated. Oxygen saturation shall be evaluated continuously by pulse oximetry except as provided in subparagraph (F) of this paragraph.

(ii)

Ventilation. Must perform observation of chest excursions and/or auscultation of breath sounds.

(iii)

Circulation.

(I)

Shall take and record blood pressure and pulse continually at least every 10 minutes;

(II)

Shall perform continuous EKG monitoring of all patients with electrocardioscopy, except as provided in subparagraph (F) of this paragraph. of this section.

(iv)

Documentation. A written time-oriented anesthetic record must be maintained. Individuals present during the administration of parenteral conscious sedation shall be documented.

(E)

Recovery and Discharge. [ in utilizing parenteral conscious sedation via an intravenous (IV) route of administration, the dentist shall: ]

(i)

positive pressure oxygen and suction equipment must be immediately available in the recovery area and/or operatory; [ maintain personal supervision of the patient during the induction of conscious sedation and for a period of time necessary to establish pharmacologic and physiologic vital sign stability. When a certified registered nurse anesthetist (CRNA) provides the conscious sedation care, he/she shall be under the direct supervision of the dentist. Delegation of personal supervision may occur if a second dentist or anesthesiologist is delivering the anesthesia care; and ]

(ii)

continual monitoring of vital signs when the sedation/anesthesia is no longer being administered; i.e., the patient must have continuous supervision until oxygenation, ventilation and circulation are stable and the patient is appropriately responsive for discharge from the facility; [ utilize visual and mechanical methods for vital sign monitoring which shall include, but shall not necessarily be limited to, pulse rate, patient color texture, blood pressure, respiration, blood and tissue oxygenation. Mechanical monitoring shall include a minimum of pulse oximetry; ]

(iii)

the dentist must determine and provide for documentation that oxygenation, ventilation, circulation, activity, skin color and level of consciousness are appropriate and stable prior to discharge;

(iv)

must provide explanation and documentation of postoperative instructions to patient and/or a responsible adult at time of discharge;

(v)

the dentist must determine that the patient has met discharge criteria prior to leaving the office.

(F)

Special situations include multiple/combination techniques and single dosage techniques (IN, IM and SC) and types of special patients. In selected circumstances, parenteral conscious sedation may be utilized without establishing an indwelling intravenous line or continuous EKG monitoring with electrocardioscopy or pulse oximerty. These circumstances include sedation for very brief procedures; young children managed entirely by non-intravenous techniques; or the establishment of intravenous access, EKG monitoring, or pulse oximetry after sedation has been induced due to poor patient cooperation. Vital sign monitoring and IV access during special situations should in as far as possible adhere to generally accepted standards of care. When these situations occur, the dentist responsible for administering parenteral conscious sedation shall document the reasons preventing the recommended preoperative or intraoperative management. [ maintain direct supervision of auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of parenteral conscious sedation; and ]

(G)

Emergency Management. [ not allow a parenteral conscious sedation procedure to be performed in his/her office by a certified registered nurse anesthetist (CRNA) unless the dentist holds a permit for the procedure being performed issued by the Texas State Board of Dental Examiners. ]

(i)

the sedation/anesthesia permit holder/provider is responsible for the anesthetic management, adequacy of the facility and treatment of emergencies associated with the administration of parenteral conscious sedation, including immediate access to pharmacologic antagonists and equipment for establishing a patent airway and providing positive pressure ventilation with oxygen;

(ii)

advanced airway equipment, resuscitation medications must be available.

(iii)

a defibrillator should be immediately available when ASA I and ASA II status patients are consciously sedated and, a defibrillator must be immediately available when ASA III and ASA IV status patients are consciously sedated.

(c)

Parenteral deep sedation and/or general anesthesia. To induce and maintain parenteral deep sedation/general anesthesia on patients having dental/oral and maxillofacial surgical procedures in the State of Texas, the following requirements must be met:

(1)

Professional Requirements: [ Deep sedation/general anesthesia shall be induced and maintained by a dentist licensed by the State of Texas and practicing in Texas, a physician anesthesiologist licensed by the Texas State Board of Medical Examiners, or a certified registered nurse anesthetist licensed in Texas. (see paragraph (3) (G) of this subsection). ]

(A)

Each dentist wishing to utilize either of these techniques must be permitted by the State Board of Dental Examiners (SBDE) to deliver parenteral deep sedation and/or general anesthesia after having met the education requirements as detailed in rule 109.174 (g)(3) of this title (relating to Sedation/Anesthesia Permit).

(B)

Parenteral deep sedation/general anesthesia shall be induced and maintained by a dentist licensed by the State of Texas and practicing in Texas, a physician anesthesiologist licensed by the Texas State Board of Medical Examiners, or a Certified Registered Nurse Anesthetist (CRNA) licensed in Texas.

(2)

Standard of care requirements. Each dentist must maintain the minimum standard of care as detailed in rule 109.173 of this title (relating to Minimum Standard of Care) and shall in addition: [ professional requirements are as follows: ]

(A)

adhere to the clinical requirements as detailed in paragraph (3) of this subsection; [ has completed a minimum of one year of advanced training in anesthesia and related academic subjects beyond the undergraduate dental school level in a training program as described in Part II of the "Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry" of the American Dental Association Council on Dental Education; or ]

(B)

maintain a written parenteral deep sedation and/or general anesthesia consent for each dental patient on whom each procedure is performed, such consent shall specify that the risks related to the procedure include cardiac arrest, brain injury and death: [ has completed an approved graduate program by the Commission on Dental Accreditation of the American Dental Association where training to competency in general anesthesia is a minimum standard in the training guidelines and maintains an equivalency to one year of anesthesia training (oral and maxillofacial surgery); or ]

(C)

maintain a time oriented, written anesthetic record which shall record dosages of anesthetic agents utilized and shall include physiologic vital sign monitoring during the course of the procedure; [ has completed the requirements for admission to and has passed the fellowship exam in the American Dental Society of Anesthesiology. ]

(D)

maintain under continuous direct supervision a minimum of two auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of parenteral deep sedation and/or general anesthesia;

(E)

maintain current certification in basic cardiopulmonary resuscitation for the assistant staff by having them pass a course sponsored by the American Heart Association or the American Red Cross;

(F)

not allow a parenteral deep sedation and/or general anesthesia procedure to be performed in his/her office by a Certified Registered Nurse Anesthetist (CRNA) unless the dentist holds a permit issued by the State Board of Dental Examiners for the procedure being performed.

(3)

Clinical Requirements. Each dentist must meet the following clinical requirements for utilization of parenteral deep sedation and/or general anesthesia: [ Standard of care requirements. Each dentist shall utilize the following standard of care in addition to the minimum standards noted in 109.173 of this title (relating to Minimum Standard of Care): ]

(A)

Patient Evaluation. Patients subjected to parenteral deep sedation/general anesthesia must be suitably evaluated prior to the start of any sedative/anesthetic procedure. In healthy or medically stable individuals (ASA I, II) this may be simply a review of their current medical history and medication use. However, with individuals who may not be medically stable or who have a significant health disability (ASA III, IV), consultation with their primary care physician or consulting medical specialist regarding potential procedure risk or special monitoring should be considered. [ maintain an informed deep sedation/general anesthesia consent by each dental patient on whom this technique is performed, which consent shall specify that the risks related to the procedure include brain damage and death; ]

(B)

Pre-Procedure preparation, informed consent: [ maintain an adequate written anesthesia record which shall include, but shall not necessarily be limited to, physiologic vital signs and all medications administered during the course of the procedure; ]

(i)

the patient and/or guardian must be advised of the procedure associated with the delivery of any sedative agents and the appropriate informed consent should be obtained;

(ii)

if inhalation equipment is used in conjunction with parenteral deep sedation and/or general anesthesia, the equipment must be evaluated for proper operation and delivery of inhalation agents prior to use on each patient;

(iii)

determination of adequate oxygen supply must be completed prior to use with each patient;

(iv)

baseline vital signs should be obtained;

(v)

pre-treatment physical evaluation should be performed as deemed appropriate;

(vi)

specific dietary restrictions must be delineated based on technique used and patient's physical status;

(vii)

appropriate verbal or written instructions regarding the procedure must be given to the patient and/or guardian;

(viii)

an intravenous line which is secured throughout the procedure must be established, except as provided in subparagraph (F) of this paragraph..

(C)

Personnel and Equipment Requirements: [ maintain personal supervision of the patient during the induction and maintenance of the anesthesia. When a certified registered nurse anesthetist (CRNA) provides the deep sedation/anesthesia care, he/she shall be under the direct supervision of the dentist. Delegation of personal supervision may occur if a second dentist or anesthesiologist is delivering the deep sedation/anesthesia care. Vital sign monitoring shall utilize visual and mechanical methods which shall include, but shall not necessarily be limited to, pulse rate, patient color/texture, blood pressure, respiration, blood and tissue oxygenation, and heart rhythm. Mechanical monitoring shall include a minimum of pulse oximetry and an electrocardioscope. ]

(i)

a provider permitted to administer parenteral deep sedation and/or general anesthesia shall be designated to be in charge of the administration of anesthesia care;

(ii)

two additional individuals who are currently certified in basic cardiopulmonary resuscitation or its equivalent, one of whom is trained in patient monitoring shall be present for the delivery of anesthesia care;

(iii)

when the same individual administering the parenteral deep sedation and/or general anesthesia is performing the dental/oral and maxillofacial procedure, one of the additional two individuals present for the delivery of anesthesia care must monitor the patient and record required information on the anesthesia record;

(iv)

equipment suitable to provide advanced airway management and advanced life support should be on premises and available for use.

(v)

any inhalation equipment utilized in conjunction with parenteral deep sedation/general anesthesia must have a fail safe system that is appropriately checked and calibrated.

(vi)

if nitrous oxide/oxygen delivery equipment capable of delivering less than 25% oxygen is used, an in-line oxygen analyzer must be utilized.

(vii)

the inhalation equipment must have an appropriate nitrous oxide/oxygen scavenging system.

(viii)

regardless of the sedation/anesthesia technique, the ability of the provider and/or the facility to deliver positive pressure oxygen must be maintained.

(D)

Monitoring and Documentation. Maintain personal supervision of the patient during the induction and maintenance of parenteral deep sedation and/or general anesthesia and during maintenance of parenteral deep sedation and/or general anesthesia for a period of time necessary to establish pharmacologic and physiologic vital sign stability. When a Certified Registered Nurse Anesthetist (CRNA) provides the anesthesia care, he/she shall be under the direct supervision of the dentist in the dental office. Delegation of personal supervision may occur if a second dentist or physician anesthesiologist is delivering the anesthesia care. [ maintain original certification in advanced cardiac life support from a course sponsored by the American Heart Association. The dentist shall require his/her assistant staff to maintain current certification in basic life support as obtained by courses offered by the American Heart Association or the American Red Cross; ]

(i)

Oxygenation. Color of mucosa, skin or blood shall be continually evaluated. Oxygenation saturation shall be evaluated continuously by pulse oximetry;

(ii)

Ventilation. Intubated patient - must auscultate breath sounds and monitor of end-tidal CO2. Non-intubated patient - auscultation of breath sounds, observation of chest excursions and/or monitoring of end-tidal CO2;

(iii)

Circulation. Continuous EKG monitoring of all patients throughout the procedure with electrocardioscopy shall occur. Shall record blood pressure and pulse continually at least every five minutes;

(iv)

Temperature. A device capable of measuring body temperature should be readily available, if needed, during the administration of parenteral deep sedation/general anesthesia. When agents implicated in precipitating malignant hyperthermia are utilized, continual monitoring of body temperature must be performed;

(v)

Documentation. A written time-oriented anesthetic record must be maintained. Individuals present during the administration of parenteral deep sedation/general anesthesia shall be documented.

(E)

Recovery and Discharge: [ maintain the necessary emergency equipment and medications to perform advanced cardiac life support under the guidelines of the American Heart Association (airway equipment, required intravenous equipment and medication, defibrillator, electrocardioscope, etc. ]

(i)

oxygen and suction equipment must be immediately available in the recovery area and/or operatory;

(ii)

continual monitoring of vital signs when the anesthetic is no longer being administered, i.e., the patient must have continuous supervision until oxygenation, ventilation, circulation and temperature, as indicated, are stable and the patient is appropriately responsive for discharge from the facility;

(iii)

the dentist must determine and document that oxygenation, ventilation, circulation activity, skin color, level of consciousness and temperature, as indicated, are stable prior to discharge;

(iv)

must provide explanation and documentation of post-operative instructions to patient and/or a responsible adult at the time of discharge.

(v)

the dentist must determine and provide for documentation that the patient has met discharge criteria prior to leaving the office.

(F)

Special situations include multiple/combination techniques single dosage techniques (IN, IM and SC) and types of special patients: [ maintain a minimum of two auxiliary personnel who shall be capable of reasonably assisting in procedures, problems, and emergencies incident to the use of deep sedation/general anesthesia; and ]

(i)

In selected circumstances, parenteral deep sedation/general anesthesia may be utilized without first establishing an indwelling intravenous line. These circumstances include parenteral deep sedation/general anesthesia for very brief procedures, or brief periods of time, which, for example, may occur in some pediatric patients; or the establishment of intravenous access after parenteral deep sedation/general anesthesia has been induced due to poor patient cooperation. Vital sign monitoring and IV access during special situations should in as far as possible adhere to generally accepted standards of care. When these situations occur, the dentist responsible for administering parenteral deep sedation/general anesthesia shall document the reasons preventing the recommended preoperative of intraoperative management.

(ii)

Due to the fact that some dental patients undergoing parenteral deep sedation/general anesthesia are mentally and/or physically challenged, it is not always possible to suitably evaluate these patients prior to administering care. When these situations occur, the dentist responsible for administering the parenteral deep sedation/general anesthesia shall document the reasons preventing the recommended preoperative management.

(G)

Emergency Management: [ not allow a deep sedation/general anesthesia procedure to be performed on a dental patient in his/her office by a certified registered nurse anesthetist (CRNA) unless the dentist maintains a permit for deep sedation/general anesthesia issued by the Texas State Board of Dental Examiners ]

(i)

the anesthesia permit holder/provider is responsible for the anesthetic management, adequacy of the facility and treatment of emergencies associated with the administration of parenteral deep sedation and/or general anesthesia including immediate access to pharmacologic antagonists and equipment for establishing a patent airway and providing positive pressure ventilation with oxygen;

(ii)

advanced airway equipment, resuscitation medications and a defibrillator must also be immediately available;

(iii)

appropriate pharmacologic agents must be immediately available if known triggering agents of malignant hyperthermia are part of the anesthesia plan.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902008

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


Subchapter T. Agreements with Non-dentists

22 TAC §109.500

The State Board of Dental Examiners proposes new Subchapter T, Agreements with Non-Dentists, new §109.500, concerning management service agreements.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for state or local government as a result of enforcing the rule.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be to clarify the activities that individuals or entities having management service contracts or agreements with a dentist or an organization providing dental services will result in the contract management practicing dentistry in violation of the Dental Practice Act.

It is unknown if there will be any fiscal implications for small businesses. Should such costs be incurred they will not be of such magnitude to impact the economic viability of a small business. Therefore the SBDE has determined that compliance with the proposed new rule will not have an adverse economic impact on small businesses as the cost of compliance, if any, will be minimal.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400 To be considered all comments must be received by the State Board of Dental Examiners on or before May 17, 1999.

The new rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act, and Article 4551a which defines the practice of dentistry.

The proposed new rule does not affect other statutes, articles, or codes.

§109.500.Management Service Agreement.

(a)

For the purposes of this rule, the term dentist shall include the following:

(1)

a dentist licensed by the State Board of Dental Examiners;

(2)

a professional corporation wholly owned by one or more dentists;

(3)

other entities composed of wholly owned by, or controlled by a dentist or dentists.

(b)

Any dentist entering into any contract, partnership or other agreement which allows any person other than a dentist any one or more of the following rights, powers or authorities shall be presumed to have violated the provisions of the Dental Practice Act, Article 4551a regarding managing, controlling, attempting to control, influencing, attempting to influence or otherwise interfering with the exercise of a dentist's independent professional judgment regarding the diagnosis or treatment of any dental disease, disorder or physical condition:

(1)

controlling, owning or setting any conditions for access to or the specific contents of dental records of patients of a dentist.

(2)

setting a maximum or other standardized time for the performance of specific dental procedures.

(3)

placing any limitations or requirements on treatments, referrals, or consultations except those based on the professional judgment of the dentist.

(4)

limiting or imposing requirements concerning the type or scope of dental treatment, procedures or services which may be recommended, prescribed, directed or performed, except that a dentist may limit the dentist's practice or the practice of a dentist employed by or contracting with the dentist to certain procedures or the treatment of certain dental diseases.

(5)

limiting or imposing requirements concerning the supplies, instruments or equipment deemed reasonably necessary by a dentist to provide diagnoses and treatment of the patients of the dentist.

(6)

limiting or imposing requirements for the professional training deemed necessary by the dentist to properly serve the patients of the dentist.

(7)

directing or influencing the selection of specific diagnostic examinations and treatment or practices regarding patients without due regard to the recommended diagnostic examinations and treatment agreed upon by the dentist and the patient, except that a dentist having the responsibility for training or supervising another dentist may reasonably limit treatment or practices as a part of the training or supervision of a dentist based upon the training and competency of a dentist to perform certain treatment or practices.

(8)

limiting or determining the duties of professional, clinical or other personnel employed to assist a dentist in the practice of dentistry.

(9)

establishing professional standards, protocols or practice guidelines which in the professional judgment of the dentist providing dental service to the dentist's patient, conflict with generally accepted standards within the dental profession.

(10)

entering into a dental practice management agreement providing for a fee determined by a percentage of the revenue earned by a dentist from the dentist's practice.

(11)

placing limitations or conditions upon communications that are clinical in nature with the dentist's patients.

(12)

precluding or restricting a dentist's ability to exercise independent professional judgment over all qualitative and quantitative aspects of the delivery of dental care.

(13)

scheduling patients of the dentist in a manner that may have the effect of discouraging new patients from coming into the dentist's practice, or postponing future appointments or that give scheduling preference to an individual, class or group.

(14)

penalizing a dentist for reporting violations of a law regulating the practice of dentistry.

(15)

conditioning the payment of fees to a dentist or the amount of management fees a dentist must pay, on the referral of patients to other health care providers specified by a non-dentist, or collecting a management fee that is not reasonably related to the fair market value of services provided.

(c)

The entry into one or more of the following agreements by a dentist shall not be presumed to have violated the Texas Dental Practice Act, Article 4551a, Section (8):

(1)

leases, mortgages, ownership agreements or other arrangements regarding use of space for dental offices, based on a set, non percentage fee reasonably related to the fair market value of the office space provided at the time the lease or other arrangement is entered into.

(2)

agreements regarding the purchase, sale, financing or lease of dental equipment, instruments and supplies so long as the dentist maintains the complete care, custody, and control of the dental instruments and supplies and the lease does not provide for a payment or fee based upon a percentage of the revenue received by the dentist, or the dental practice.

(3)

agreements providing for accounting, bookkeeping, investment or similar financial services.

(4)

the financing, lease, use or ownership of non-dentist business equipment such as telephones, computers, software, and general office equipment at reasonable, market related fees.

(5)

services regarding the pledge, collection or sale of accounts receivable from patients.

(6)

agreements regarding billing and collection services.

(7)

advertising and marketing services so long as the dentist remains solely responsible for the content of any advertising or marketing services and for ensuring that such conform to all applicable legal requirements.

(8)

agreements regarding consulting, professional development, business practices and other advisory agreements which do not limit the dentist's ability to use the dentist's independent professional judgment regarding the diagnosis or treatment of any dental disease, disorder or physical condition.

(9)

employment agreements which specify that the dentist shall continue to have the right to use the dentist's independent professional judgment regarding the diagnosis or treatment of any dental disease, disorder or physical condition, provided that in practice the dentist is allowed to use the dentist's professional judgment.

(d)

The provisions of subsection (c) of this section herein may be rebutted and the entry into these agreements or other undertakings may be found to be in violation of the Dental Practice Act if it can be shown that the agreements or other undertakings result in the control, attempt to control, influence, attempt to influence or otherwise interfere with the exercise of a dentist's independent professional judgment regarding the diagnosis or treatment of any dental disease, disorder or physical condition.

(e)

This rule shall not be applicable to dentists or others covered by Article 4551b, entitled Exceptions, Article 4551m, regarding administration of an estate and continuation of practice nor Article 4551n regarding employment of dentists.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902009

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


Chapter 115. Extension of Duties of Auxiliary Personnel Dental Hygiene

22 TAC §115.20

The State Board of Dental Examiners proposes amendments to §115.20, concerning the Dental Hygiene Advisory Committee its purpose and composition.

Douglas A. Beran, Executive Director, State Board of Dental Examiners, has determined that for the first five-year period the rule is in effect there will be no fiscal implications for local government as a result of enforcing the rule; however, for state government, there will be an annual fiscal implication of approximately $720 compensatory per diem and $2,400 transportation expenses for members of the Dental Hygiene Advisory Committee.

Mr. Beran has determined that for each year of the first five years the rule is in effect the public benefit anticipated as a result of enforcing the rule will be that the Dental Hygiene Advisory Committee may be continued in existence for four years and that the committees performance will be reviewed annually by the State Board of Dental Examiners. The Dental Hygiene Advisory Committee will advise the State Board of Dental Examiners on matters relating to dental hygiene and any rule proposed by the State Board of Dental Examiners relating to the practice of dental hygiene will be reviewed and commented upon by the Dental Hygiene Advisory Committee.

There will be no effect on small and large business and on persons who are required to comply with the rule as proposed.

Comments on the proposal may be submitted to Mei Ling Clendennen, Executive Assistant, State Board of Dental Examiners, 333 Guadalupe, Tower 3, Suite 800, Austin, Texas 78701, 512-463-6400. To be considered all comments must be received by the State Board of Dental Examiners on or before May 17, 1999.

The amended rule is proposed under Texas Government Code, §2001.021 et. seq.; Texas Civil Statutes, Article 4543 §2 and 4551d which provide the State Board of Dental Examiners with the authority to adopt and promulgate rules consistent with the Dental Practice Act, and Article 4551e, §4A, which establishes the Dental Hygiene Advisory Committee and specifies its duties.

The proposed amended rule does not affect other statutes, articles, or codes, except for Texas Government Code §2110 which addresses advisory committees in general.

§115.20.Dental Hygiene Advisory Committee - Purpose and Composition.

(a)

The Dental Hygiene Advisory Committee is established pursuant to Texas Civil Statutes, Article 4551e, §4A, for the purpose of advising the Board on matters relating to dental hygiene. [ The Committee shall be comprised of a balanced representation between members of the dental hygiene profession and consumers of services provided by the profession, pursuant to Article 6252-33, V.T.C.S. This balance shall be achieved through voluntary action of current members or through Board action in order to achieve the required representation. ]

(b)

The Board shall annually evaluate the Committee's work, its usefulness, and the costs related to the Committee's work to include agency staff time in support of the Committee's activities. Reimbursement of costs shall be determined as set out in the General Appropriations Act and under Article 4551e, §4A, .

(c)

The Committee shall elect from among its members a presiding officer who shall serve for one year and who shall report to the Board on Committee activities as may be required, but no less often than annually [ at or following the May schedule for Committee evaluation and review. This report shall coincide with the Board's annual evaluation of the Committee's work ].

(d)

The Committee is abolished on September 1, 2003, [ May 1 of the third year following adoption of these rules ] unless the Board affirmatively votes prior to that date to continue the existence of the Committee.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 5, 1999.

TRD-9902010

Douglas A. Beran, Ph.D.

Executive Director

State Board of Dental Examiners

Earliest possible date of adoption: May 16, 1999

For further information, please call: (512) 463-6400


Part VIII. Texas Appraiser Licensing and Certification Board

Chapter 153. Provisions of the Texas Appraiser Licensing and Certification Act

22 TAC §153.18

The Texas Appraiser Licensing and Certification Board proposes an amendment to §153.18, relating to continuing education required for the renewal of an appraiser trainee authorization. The amendment will clarify and resolve confusion as to the number of classroom hours required to be devoted to the Uniform Standards of Professional Appraisal Practice (USPAP) required for the third, fifth, seventh, etc. renewals, and increase that amount to 15 hours.

Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Mr. Liner also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be for appraiser trainees to be better educated in the Uniform Standards of Professional Appraisal Practice (USPAP)which will result in more competent and knowledgeable appraisals which in tern will protect financial institutions and the public. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the section as proposed.

Comments on the proposal may be submitted Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, P.O. Box 12188 Austin, Texas 78711-2188.

The amendment is proposed under the Powers and Duties of the Board, Texas Appraiser Licensing and Certification Act, §5 (Texas Civil Statutes, Article 6573a.2), which provides the board with authority to adopt rules. Section 14, Certificate and License Renewal, and Section 17, Appraiser Trainees, will be affected by the proposal.

§153.18.Appraiser Continuing Education.

(a)

(No change.)

(b)

Renewing an Appraiser Trainee Authorization. As a condition for renewing an appraiser trainee authorization, a trainee must successfully complete educational courses during the one-year period preceding the expiration of the appraiser trainee authorization being renewed. The courses must comply with the fundamental education requirements for application for licensing and certification set out is §153.13 (e)-(n) of this title (relating to Educational Requirements):

(1)-(2)

(No change.)

(3)

Beginning with the third annual renewal, every other annual renewal (third, fifth, seventh, etc.) must include a minimum of 15 [ 7 ] classroom hours devoted to the USPAP , which shall include the successful completion of an examination, in addition to [ as part of the ] 30 classroom hours of fundamental real estate appraisal courses specifically approved by the board ;

(c)-(d)

(No change.)

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 1, 1999.

TRD-9901962

Renil C. Liner

Commissioner

Texas Appraiser Licensing and Certification Board

Proposed date of adoption: May 16, 1999

For further information, please call: (512) 465-3950


22 TAC §153.22

The Texas Appraiser Licensing and Certification Board proposes new §153.22, License Holder's Responsibility to the Board. New §153.22 is being added to clarify that all licensees are subject to all provisions of the Act, and to provide that all licensees and those applying for renewals, must respond to inquiries of the Board within 20 days and comply with final actions and orders of the board or be subject to disciplinary action.

Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Mr. Liner also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be for the board to more efficiently and effectively carry out, respond to and resolve complaints and its other licensing and regulatory duties, and to assure adherence to decisions and final orders of the board. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the section as proposed.

Comments on the proposal may be submitted to Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, P.O. Box 12188 Austin, Texas 78711-2188.

The new section is proposed under the Powers and Duties of the Board, Texas Appraiser Licensing and Certification Act, §5 (Texas Civil Statutes, Article 6573a.2), which provides the board with authority to adopt rules. Section 12, Enforcement Proceedings; Section 12A, Contested Case Proceedings; and Section 14, Certificate and License Renewal, may be affected by the proposal.

§153.22.License Holder's Responsibility to the Board.

(a)

A certified or licensed appraiser or appraiser trainee or applicant for renewal is subject to all provisions of the Act and board rules and shall, within 20 days of notice to said individual's address of record, unless granted a written extension by the board, answer all inquiries concerning matters under the jurisdiction of the board, and shall fully comply with final decisions and orders of the board.

(b)

Failure to comply with this section constitutes a separate violation of §152.20(a)(2) of this title (relating to Guidelines for Revocation, Suspension or Denial of Licensure or Certification).

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 1, 1999.

TRD-9901961

Renil C. Liner

Commissioner

Texas Appraiser Licensing and Certification Board

Proposed date of adoption: May 16, 1999

For further information, please call: (512) 465-3950


Chapter 155. Rules Relating to Standards of Practice

22 TAC §155.1

As part of the rule review specified by the General Appropriations Act, HB-1, 75th Legislature, Regular Session, 1997, the Texas Appraiser Licensing and Certification Board proposes an amendment to §155.1, relating to Standards of Practice. The amendment will require that all licensees comply with the Uniform Standards of Professional Appraisal Practice (USPAP)in all their appraisal activities by adding "appraisal service," and "appraisal practice" to the more narrowly defined "appraisal."

Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.

Mr. Liner also has determined that for each year of the first five years the section is in effect the public benefit anticipated as a result of enforcing the section will be the users of appraisal services, financial institutions and the public will be better served and protected by eliminating a possible loophole in the requirement for compliance with the Uniform Standards of Professional Appraisal Practice (USPAP) in all appraisal activities by licensees. There will be no effect on small businesses. There is no anticipated economic cost to persons who are required to comply with the section as proposed.

Comments on the proposal may be submitted to Renil C. Liner, Commissioner, Texas Appraiser Licensing and Certification Board, P.O. Box 12188 Austin, Texas 78711-2188.

The new section is proposed under the Powers and Duties of the Board, Texas Appraiser Licensing and Certification Act, §5 (Texas Civil Statutes, Article 6573a.2), which provides the board with authority to adopt rules. Section 12, Enforcement Proceedings, and Section 12A, Contested Case Proceedings, will be affected by the proposal.

§155.1.Standards of Practice.

An appraisal , appraisal service, or appraisal practice, performed by a person subject to the Texas Appraiser Licensing and Certification Act must conform with the "Uniform Standards of Professional Appraisal Practice" (USPAP) of the Appraisal Foundation in effect at the time of the appraisal , appraisal service, or appraisal practice .

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State, on April 2, 1999.

TRD-9901999

Renil C. Liner

Commissioner

Texas Appraiser Licensing and Certification Board

Proposed date of adoption: May 16, 1999

For further information, please call: (512) 465-3950