ARC 4556C

ARC 4556C

DENTAL BOARD[650]

Adopted and Filed

Rule making related to sedation and nitrous oxide

The Dental Board hereby rescinds Chapter 29, "Sedation and Nitrous Oxide Inhalation Analysis," and adopts a new Chapter 29, "Sedation and Nitrous Oxide," Iowa Administrative Code.

Legal Authority for Rule Making

This rule making is adopted under the authority provided in Iowa Code sections 147.76 and 153.33.

State or Federal Law Implemented

This rule making implements, in whole or in part, Iowa Code sections 153.33 and 153.33B.

Purpose and Summary

The primary purpose of this rule making is to update the requirements for providing sedation and nitrous oxide in dental offices. The rules in new Chapter 29 were drafted based on updated recommendations from the American Dental Association and input from the Board's Anesthesia Credentials Committee.

The new chapter contains updated requirements for providing moderate sedation, deep sedation and general anesthesia in dental offices. The chapter specifies the conditions under which the administration of the sedation services may be performed by another health care provider, such as an anesthesiologist or nurse anesthetist.

The new chapter clarifies that training in the use of nitrous oxide during enrollment in an accredited school of dentistry or dental hygiene is approved for the purposes of these rules. The chapter also clarifies what a dental assistant is allowed to do or required to do, or both, while monitoring the administration of nitrous oxide.

The new chapter establishes a requirement for training in the monitoring of patients under moderate sedation, deep sedation or general anesthesia. Due to the increased risk of these levels of sedation, the training allows an option to focus on additional training in observation of a patient under sedation and prepare staff to recognize signs of an adverse reaction or occurrence.

The new chapter establishes a prohibition of the use of drugs intended for deeper levels of sedation from being employed for the purposes of moderate sedation. The chapter clarifies which facilities and locations are subject to inspection and specifies the equipment required to be maintained at each facility where moderate sedation, deep sedation or general anesthesia, or all three are performed.

The new chapter contains updated terminology to be more specific and clarifies the requirements for providing sedation or nitrous oxide inhalation analgesia. The new chapter also reflects the reordering of some rules for clearer understanding and reference.

Public Comment and Changes to Rule Making

Notice of Intended Action for this rule making was published in the Iowa Administrative Bulletin on March 27, 2019, as ARC 4358C. Four written comments were received and reviewed by the Board.

One of the comments received was fully in support of the rules and recommended that the Board adopt the rules as originally drafted. The remaining three comments, submitted by the Iowa Association of Nurse Anesthetists (IANA) and the Iowa Society of Anesthesiologists (ISA), were generally supportive of the rules but included suggestions for changes to some of the provisions proposed in the Notice of Intended Action. The comments and suggestions are summarized below.

Comments from IANA:

1.IANA disagrees with the use of the term "delegated" in conjunction with requesting the services of another anesthesia provider. IANA requests that the Board update the language in the preamble to strike "delegated to" from the language, and use other terminology such as "performed by" or other similar language.

2.IANA requests that the use of the term "patient monitor" as defined in rule 650—29.1(153) be changed to other terminology to minimize confusion. IANA states that "patient monitor" generally refers to a piece of equipment and not to a licensee/registrant whose purpose is to observe the patient while under sedation. IANA suggests use of "patient observer" or "patient supervisor" in lieu of "patient monitor."

3.IANA requests that the Board clarify or update rules (29.6(2), 29.7(2)) to allow another anesthesia provider (as defined in the draft) to provide sedation services to pediatric patients and ASA III, IV patients even in cases where the dentist permit holder may not have that specific qualification. IANA indicates that the scope of practice would allow a CRNA or anesthesiologist to provide those services without additional qualifications or training.

4.IANA requests that the Board clarify or update the rule (29.6(3)) to allow an anesthesia provider (CRNA, anesthesiologist) to be counted as one of the licensees/registrants required to monitor a patient under sedation.

5.IANA requests that the Board clarify that the proposed rule (29.9(2)) would allow a moderate sedation permit holder or a general anesthesia permit holder to allow an anesthesia provider to administer moderate sedation, deep sedation, or general anesthesia in a dental office regardless of the specific permit held by the dentist.

6.IANA requests that the Board clarify or update subrule 29.9(2) that the dentist need not remain present in the recovery room/area following completion of the dental procedure in cases when an anesthesia provider has administered the sedation.

7.IANA requests that the Board update subrule 29.9(4) to specify that an anesthesia provider is allowed (or not restricted) to determine patient suitability for sedation separate and apart from any decisions made by the dentist.

Comments from ISA:

In its first written comments, ISA primarily referenced the 2015 "Standards for Basic Anesthetic Monitoring" issued by the American Society of Anesthesiologists (ASA), and legal changes related to sedation in California.

ISA submitted additional written comments on May 15, 2019, which are intended to be a supplement to the comments submitted previously.

1.ISA referred to the ASA recommendation that "qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care."

2.ISA requests that an individual other than the practitioner performing the procedure be designated to monitor the patient throughout the procedure. The comments referred to a recommendation for a dedicated and independent anesthesia provider if the patient is under the age of seven as "a recommendation contained in the California Dental Board's new rules."

3.ISA requests that the individual responsible for monitoring the patient be trained in the recognition of apnea and airway obstruction and be authorized to seek additional help.

4.ISA requests that the individual responsible for monitoring the patient not be a member of the procedural team and that the individual only be allowed to assist with minor, interruptible tasks.

5.ISA requests that two patient monitors be required for moderate sedation.

6.ISA requests that the Board require that a licensed sedation provider be required to serve as one of the two patient monitors required when deep sedation or general anesthesia is administered in a dental office. ISA does not believe that a dentist with a general anesthesia permit is able to adequately supervise the patient monitors. More specifically, ISA believes that the requirements for patient monitors as proposed in the Notice are inadequate in situations where a patient requires the sedation to be redosed during the procedure.

Following discussion at its meeting, the Board adopted this rule making, which includes rule revisions in response to comments as follows:

Responses to IANA comments/suggestions:

Comment 1. Updated language in the preamble of this rule making as suggested.

Comment 2. The Board did not adopt the recommendations made in this comment. The ADA guidelines almost exclusively reference the term "monitor" with respect to the service provided by the licensee/registrant to the patient who is under sedation.

Comment 3. Revised subrule 29.9(1) to update the rules as requested.

Comment 4. Added a new subrule 29.9(3) to clarify the rules as requested and renumbered the subsequent subrules of the rule.

Comment 5. Revised subrule 29.9(1) to clarify the rules as requested.

Comment 6. Revised subrule 29.9(2) to clarify the rules as requested.

Comment 7. Revised renumbered subrule 29.9(5) to clarify the rules as requested.

Responses to ISA comments/suggestions:

Comment 1. The Board did not adopt the recommendations made in this comment as the Board believes that the sedation training requirements are sufficient for the purposes of administering sedation in dental offices.

Comment 2. The Board did not adopt the recommendations made in this comment since the standard referred to in this comment was not included in the California legislation that was signed into law. Additionally, the new California law will not become effective until 2022.

Comment 3. Revised subrule 29.6(3) to further clarify the training required of licensees/registrants to serve as a patient monitor.

Comment 4. Revised the definition of "patient monitor" in rule 650—29.1(153) to clarify that the primary responsibility of the patient monitor shall be to observe the patient under sedation.

Comment 5. The Board did not adopt the recommendations made in this comment since studies have not conclusively shown that two patient monitors increase safety to the patient when moderate sedation is administered.

Comment 6. The Board did not adopt the recommendations made in this comment since the rules provide minimum training standards for deep sedation/general anesthesia, which include successful completion of a Commission on Dental Accreditation (CODA)-accredited advanced education program that includes training in deep sedation and general anesthesia and a minimum of one year of advanced training in anesthesiology and related academic subjects. Additionally, the rules allow a licensed dentist to request the services of another licensed sedation provider (e.g., an anesthesiologist, a nurse anesthetist, or another dentist with a sedation permit) if the dentist believes that doing so is preferable or warranted. There is not any evidence that suggests that the higher standard of regulation increases patient safety. Should the evidence become available, the Board could revisit the issue quickly and amend the rules as deemed appropriate. Lastly, concerns have been raised about diminished access to care due to increased costs for services if the standards recommended in the comment were to be adopted.

Adoption of Rule Making

This rule making was adopted by the Board on June 7, 2019.

Fiscal Impact

This rule making has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rule making, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Board for a waiver of the discretionary provisions, if any, pursuant to 650—Chapter 7.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

Effective Date

This rule making will become effective on August 21, 2019.

The following rule-making action is adopted:

Rescind 650—Chapter 29 and adopt the following new chapter in lieu thereof:

CHAPTER 29

SEDATION AND NITROUS OXIDE

650—29.1(153) Definitions. For the purpose of these rules, relative to the administration of deep sedation, general anesthesia, moderate sedation, minimal sedation, and nitrous oxide inhalation analgesia by licensed dentists, the following definitions shall apply:

"ACC" means the anesthesia credentials committee of the board.

"ASA" refers to the American Society of Anesthesiologists Patient Physical Status Classification System. Category I means normal healthy patients, and category II means patients with mild systemic disease. Category III means patients with severe systemic disease, and category IV means patients with severe systemic disease that is a constant threat to life.

"Board" means the Iowa dental board established in Iowa Code section 147.14(1)"d."

"Capnography" means the monitoring of the concentration of exhaled carbon dioxide in order to assess physiologic status or determine the adequacy of ventilation during anesthesia.

"Current ACLS or PALS certification" means current certification in advanced cardiac life support (ACLS) or pediatric advanced life support (PALS). Current certification means certification by an organization on an annual basis or, if that certifying organization requires certification on a less frequent basis, evidence that the individual has been properly certified for each year covered by the renewal period. The course for the purposes of certification must include a clinical component.

"DAANCE" means the dental anesthesia assistant national certification examination as offered by the American Association of Oral and Maxillofacial Surgeons (AAOMS).

"Deep sedation" means drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.

"Facility" means any dental office or clinic where sedation is used in the practice of dentistry. The term "facility" does not include a hospital.

"General anesthesia" means a drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

"Licensed sedation provider" means a physician anesthesiologist currently licensed by the Iowa board of medicine or a certified registered nurse anesthetist (CRNA) currently licensed by the Iowa board of nursing.

"Minimal sedation" means a minimally depressed level of consciousness produced by a pharmacological method that retains the patient's ability to independently and continuously maintain an airway and respond normally to tactile stimulation and verbal command. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. A patient whose only response reflex is withdrawal from repeated painful stimuli is not considered to be in a state of minimal sedation.

"Moderate sedation" means a drug-induced depression of consciousness, either by enteral or parenteral means, during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. A patient whose only response reflex is withdrawal from a painful stimulus is not considered to be in a state of moderate sedation.

"Monitoring nitrous oxide inhalation analgesia" means continually observing the patient receiving nitrous oxide and recognizing and notifying the dentist of any adverse reactions or complications.

"MRD" means the manufacturer's maximum recommended dose of a drug as printed in FDA-approved labeling.

"Nitrous oxide inhalation analgesia" refers to 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 or verbal command.

"Patient monitor" means a dental assistant, dental hygienist, nurse or dentist whose primary responsibility is to continuously monitor a patient receiving moderate sedation, deep sedation or general anesthesia until the patient meets the criteria to be discharged to the recovery area.

"Pediatric" means patients aged 12 or under.

"Permit holder" means an Iowa licensed dentist who has been issued a moderate sedation or general anesthesia permit by the board.

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

650—29.2(153) Advertising. A dentist shall ensure that any advertisements related to the availability of antianxiety premedication or minimal sedation clearly reflect the level of sedation provided and are not misleading.

650—29.3(153) Nitrous oxide inhalation analgesia.

29.3(1) A dentist may use nitrous oxide inhalation analgesia sedation on an outpatient basis for dental patients provided the dentist has completed training and complies with the following:

a. Has adequate equipment with fail-safe features.

b. Has routine inspection, calibration, and maintenance on equipment performed every two years and maintains documentation of such and provides documentation to the board upon request.

c. Ensures the patient is continually monitored by a patient monitor while receiving nitrous oxide inhalation analgesia.

29.3(2) A dentist shall provide direct supervision of the administration and monitoring of nitrous oxide and establish a written office protocol for taking vital signs, adjusting anesthetic concentrations, and addressing emergency situations that may arise. The dentist shall be responsible for dismissing the patient following completion of the procedure.

29.3(3) A dental hygienist may administer and monitor nitrous oxide inhalation analgesia provided the services have been prescribed by a dentist and the hygienist has completed training while a student in an accredited school of dental hygiene or a board-approved course of training.

29.3(4) A dental assistant may monitor a patient who is under nitrous oxide after the dentist has induced a patient and established the maintenance level, provided the dental assistant has completed a board-approved expanded function course. A dental assistant may make adjustments to decrease the nitrous oxide concentration while monitoring the patient or may turn off oxygen delivery at the completion of the dental procedure.

29.3(5) Record keeping. The patient chart must include the concentration administered and duration of administration, as well as any vital signs taken.

650—29.4(153) Minimal sedation standards.

29.4(1) A dentist shall evaluate a patient prior to the start of any sedative procedure. In healthy or medically stable patients (ASA I, II), the dentist should review the patient's current medical history and medication use. For a patient with significant medical considerations (ASA III, IV), a dentist may need to consult with the patient's primary care provider or consulting medical specialist. A dentist shall obtain informed consent from the patient or the patient's parent or legal guardian prior to providing minimal sedation.

29.4(2) Record keeping. A time-oriented anesthesia record must be maintained and must contain the names of all drugs administered, including local anesthetics and nitrous oxide, dosages, time administered, and monitored physiological parameters, including oxygenation, ventilation, and circulation.

29.4(3) Minimal sedation for ASA I or II nonpediatric patients.

a. A dentist may prescribe or administer a single medication for minimal sedation via the enteral route that does not exceed the MRD for unmonitored home use. A dentist may administer a supplemental dose of the same drug provided the total aggregate dose does not exceed 1.5 times the MRD on the day of treatment. The dentist shall not administer a supplemental dose until the clinical half-life of the initial dose has passed.

b. A dentist may administer a single medication for minimal sedation via the enteral route that does not exceed the MRD for monitored use on the day of treatment.

c. A dentist may utilize nitrous oxide inhalation analgesia in combination with a single enteral drug.

29.4(4) Minimal sedation for ASA III, ASA IV or pediatric patients.

a. A dentist may prescribe or administer a single medication for minimal sedation via the enteral route for ASA III or IV patients or pediatric patients that does not exceed the MRD for unmonitored home use.

b. A dentist may administer a single medication for minimal sedation via the enteral route that does not exceed the MRD for monitored use on the day of treatment.

c. A dentist may administer nitrous oxide inhalation analgesia for minimal sedation of ASA III or IV patients or pediatric patients provided the concentration does not exceed 50 percent and is not used in combination with any other drug.

650—29.5(153) Shared standards for moderate sedation, deep sedation and general anesthesia.

29.5(1) Prior to administering moderate sedation, deep sedation or general anesthesia, a dentist must obtain a current moderate sedation permit or general anesthesia permit pursuant to rule 650—29.11(153).

29.5(2) A dentist administering moderate sedation, deep sedation or general anesthesia must maintain current ACLS certification. A dentist administering moderate sedation to pediatric patients may maintain current PALS certification in lieu of current ACLS certification.

29.5(3) A dentist shall evaluate a patient prior to the start of any sedative procedure. A dentist should review a patient's medical history, medication(s) and NPO (nothing by mouth) status. For a patient with significant medical considerations (ASA III, IV), a dentist may need to consult with the patient's primary care provider or consulting medical specialist. The dentist should consult the body mass index as part of the preprocedural workup.

29.5(4) A dentist who administers sedation or anesthesia shall ensure that each facility where sedation services are provided is appropriately staffed to reasonably handle emergencies incident to the administration of sedation. A patient monitor shall be present in the treatment room and continually monitor the patient until the patient returns to a level of minimal sedation.

29.5(5) The dentist must provide postoperative verbal and written instructions to the patient and caregiver prior to discharging the patient.

29.5(6) The dentist must not leave the facility until the patient meets the criteria for discharge.

29.5(7) The dentist or another designated permit holder or licensed sedation provider must be available for postoperative aftercare for a minimum of 48 hours following the administration of sedation.

29.5(8) The dentist must establish emergency protocols which comply with the following:

a. A dentist must establish a protocol for immediate access to backup emergency services;

b. A patient monitor shall employ initial life-saving measures in the event of an emergency and shall activate the EMS system for life-threatening complications;

c. A dentist who utilizes an immobilization device must avoid chest or airway obstruction when applying the device and shall allow a hand or foot to remain exposed; and

d. The recovery room for a pediatric patient must include a functioning suction apparatus as well as the ability to provide >90% oxygen and positive-pressure ventilation, along with age- and size-appropriate rescue equipment.

29.5(9) Record keeping. A time-oriented anesthesia record must include preoperative and postoperative vital signs, drugs administered, dosage administered, anesthesia time in minutes, and monitors used. Pulse oximetry, heart rate, respiratory rate, and blood pressure must be recorded continually until the patient is fully ambulatory. The chart should contain the name of the person to whom the patient was discharged.

650—29.6(153) Moderate sedation standards.

29.6(1) Moderate sedation for ASA I or II nonpediatric patients.

a. A dentist may prescribe or administer a single enteral drug in excess of the MRD on the day of treatment.

b. A dentist may prescribe or administer a combination of more than one enteral drug.

c. A dentist may administer a medication for moderate sedation via the parenteral route.

d. A dentist may administer a medication for moderate sedation via the parenteral route in incremental doses.

e. A dentist shall ensure the drug(s) or techniques, or both, carry a margin of safety wide enough to render unintended loss of consciousness unlikely.

f. A dentist may administer nitrous oxide with more than one enteral drug.

29.6(2) Moderate sedation for ASA III, ASA IV or pediatric patients. A dentist who does not meet the requirements of paragraph 29.11(3)"c" is prohibited from administering moderate sedation to pediatric or ASA III or IV patients. The following constitutes moderate sedation:

a. The use of one or more enteral drugs in combination with nitrous oxide.

b. The administration of any intravenous drug.

29.6(3) A dentist administering moderate sedation in a facility shall have at least one patient monitor observe the patient while under moderate sedation. The patient monitor shall be capable of administering emergency support and shall complete one of the following:

a. A minimum of three hours of on-site training in airway management that provides the knowledge and skills necessary for a patient monitor to competently assist with emergencies including, but not limited to, recognizing apnea and airway obstruction;

b. Current ACLS or PALS certification; or

c. Current DAANCE certification.

29.6(4) Use of capnography or pretracheal/precordial stethoscope is required for moderate sedation providers.

a. All moderate sedation permit holders shall use capnography to monitor end-tidal carbon dioxide unless the use of capnography is precluded or invalidated by the nature of the patient, procedure or equipment.

b. In cases where the use of capnography is precluded or invalidated for the reasons listed previously, a pretracheal or precordial stethoscope must be used to continually monitor the auscultation of breath sounds at all facilities where licensed sedation providers provide sedation.

650—29.7(153) Deep sedation or general anesthesia standards.

29.7(1) The administration of anesthetic sedative agents intended for deep sedation or general anesthesia, including but not limited to Propofol, Ketamine and Dilaudid, shall constitute deep sedation or general anesthesia.

29.7(2) A dentist shall have at least two patient monitors observe the patient while the patient is under deep sedation or general anesthesia. The patient monitors who observe patients under deep sedation or general anesthesia shall be capable of administering emergency support and shall have completed one of the following:

a. Current ACLS or PALS certification; or

b. Current DAANCE certification.

29.7(3) A dentist shall use capnography and a pretracheal/precordial stethoscope.

29.7(4) If the dentist has a recovery area separate from the operatory, the recovery area must have oxygen and suction equipment.

650—29.8(153) Facility and equipment requirements for moderate sedation, deep sedation or general anesthesia.

29.8(1) Change of address or addition of facility location(s). A permit holder shall notify the board office in writing within 60 days of a change in location or the addition of a sedation facility.

29.8(2) Facilities shall be permanently equipped. A dentist who administers moderate sedation, deep sedation or general anesthesia in a facility is required to be trained in and maintain, at a minimum, the following equipment to be properly equipped:

a. Electrocardiogram (EKG) monitor;

b. Positive pressure oxygen;

c. Suction;

d. Laryngoscope and blades;

e. Endotracheal tubes;

f. Magill forceps;

g. Oral airways;

h. Stethoscope;

i. Blood pressure monitoring device;

j. Pulse oximeter;

k. Emergency drugs;

l. Defibrillator;

m. Capnography machine to monitor end-tidal carbon dioxide;

n. Pretracheal or precordial stethoscope; and

o. Any additional equipment necessary to establish intravascular or intraosseous access, which shall be available until the patient meets discharge criteria.

29.8(3) The board or designated agents of the board may conduct facility inspections. The actual costs associated with the on-site evaluation of the facility shall be the primary responsibility of the licensee. The cost to the licensee shall not exceed the fee specified in 650—Chapter 15.

650—29.9(153) Use of another licensed sedation provider or permit holder.

29.9(1) A dentist may only use the services of a licensed sedation provider or another permit holder to administer moderate sedation, deep sedation, or general anesthesia in a dental facility if the dentist holds a current moderate sedation or general anesthesia permit. A permit holder who does not meet the training requirement in paragraph 29.11(3)"c" to administer moderate sedation to pediatric or ASA III or IV patients may use a licensed sedation provider or another qualified permit holder to administer moderate sedation to pediatric or ASA III or IV patients. A dentist who does not hold a sedation permit is prohibited from using a licensed sedation provider or permit holder to provide moderate sedation, deep sedation or general anesthesia.

29.9(2) The dentist must remain present in the treatment room for the duration of any dental treatment.

29.9(3) When a licensed sedation provider or another permit holder is used to administer moderate sedation, deep sedation or general anesthesia, that provider constitutes one patient monitor for the purpose of complying with subrule 29.6(3) or 29.7(2).

29.9(4) A permit holder who has a licensed sedation provider or another permit holder administer moderate sedation, deep sedation or general anesthesia services must maintain a permanently and properly equipped facility pursuant to the provisions of this chapter.

29.9(5) A permit holder shall assess the need and the patient suitability for sedation services. A permit holder shall not interfere with any independent assessment performed by a licensed sedation provider.

650—29.10(153) Reporting of adverse occurrences related to sedation or nitrous oxide.

29.10(1) All licensed dentists must submit a report to the board office within a period of seven days of any mortality related to sedation or nitrous oxide or any other incident related to sedation or nitrous oxide which results in the patient receiving inpatient treatment at a hospital or clinic. The report shall include a complete copy of the patient record and include responses to the following:

a. Description of dental procedure.

b. Description of preoperative physical condition of patient.

c. List of drugs and dosage administered.

d. Description, in detail, of techniques utilized in administering the drugs utilized.

e. Description of adverse occurrence:

(1)Description, in detail, of symptoms of any complications, to include but not be limited to onset, and type of symptoms in patient.

(2)Treatment instituted on the patient.

(3)Response of the patient to the treatment.

f. Description of the patient's condition on termination of any procedures undertaken.

29.10(2) Failure to report an adverse occurrence, when the occurrence is related to the use of sedation or nitrous oxide, may result in disciplinary action.

650—29.11(153) Requirements for issuance of a moderate sedation or general anesthesia permit.

29.11(1) No dentist shall administer moderate sedation, deep sedation or general anesthesia for dental patients unless the dentist possesses a current permit issued by the board.

29.11(2) A dentist who intends to obtain a sedation permit must submit a completed application and pay the fee specified in 650—Chapter 15.

29.11(3) To qualify for a moderate sedation permit, the applicant shall have successfully completed the following education and training:

a. A training program, approved by the board, that consists of a minimum of 60 hours of instruction and management of at least 20 patients, or an accredited residency program that includes formal training and clinical experience in moderate sedation.

b. Training that includes rescuing patients from a deeper level of sedation than intended, including managing the airway, intravascular or intraosseous access, and reversal medications.

c. For a dentist who intends to utilize moderate sedation on pediatric or ASA III or IV patients: an accredited residency program that includes formal training in anesthesia and clinical experience in managing pediatric or ASA III or IV patients.

29.11(4) To qualify for a general anesthesia permit, the applicant shall have successfully completed the following education and training:

a. An advanced education program accredited by the Commission on Dental Accreditation that provides training in deep sedation and general anesthesia.

b. A minimum of one year of advanced training in anesthesiology and related academic subjects beyond the undergraduate dental school level, in a training program approved by the ACC.

c. Formal training in airway management.

d. Current ACLS certification.

29.11(5) Prior to issuance of a new permit, all facilities where the applicant intends to provide sedation services must have passed inspection by the board or designated agent.

29.11(6) The applicant may be required to complete a peer review evaluation, if requested by the ACC, prior to issuance of a permit.

650—29.12(153) ACC.

29.12(1) The ACC shall be chaired by a member of the board and shall include at least six additional members who are licensed to practice dentistry in Iowa. At least four members of the ACC shall hold deep sedation/general anesthesia or moderate sedation permits issued under this chapter.

29.12(2) The ACC shall perform the following duties:

a. Review all permit applications and take action as authorized.

b. Perform peer reviews as needed and report the results to the board.

c. Other duties as delegated by the board.

650—29.13(153) Review of permit applications.

29.13(1) Referral to the ACC. All applications will be referred to the ACC for review at its next scheduled meeting.

29.13(2) Review by the ACC. Following review and consideration of an application, the ACC may take any of the following actions:

a. Request additional information;

b. Request that the applicant appear for an interview;

c. Approve issuance of the permit;

d. Approve issuance of the permit under certain terms and conditions or with certain restrictions;

e. Recommend denial of the permit;

f. Refer the permit application to the board for review and consideration with or without recommendation; or

g. Request a peer review evaluation.

29.13(3) Review by board. The board shall consider applications and recommendations referred by the ACC. The board may take any of the following actions:

a. Request additional information;

b. Request that the applicant appear for an interview;

c. Grant the permit;

d. Grant the permit under certain terms and conditions or with certain restrictions; or

e. Deny the permit.

29.13(4) Appeal process for denials. If a permit application is denied, an applicant may file an appeal of the final decision using the process described in rule 650—11.10(147).

650—29.14(153) Renewal. A permit to administer deep sedation/general anesthesia or moderate sedation shall be renewed biennially at the time of license renewal. Permits expire August 31 of every even-numbered year.

29.14(1) To renew a permit, a licensee must submit the following:

a. Evidence of renewal of current ACLS certification or of current PALS certification if the permit holder provides sedation services for pediatric patients.

b. A minimum of six hours of continuing education in the area of sedation. These hours may also be submitted as part of license renewal requirements.

c. The appropriate fee for renewal as specified in 650—Chapter 15.

29.14(2) Failure to renew the permit prior to November 1 following its expiration shall cause the permit to lapse and become invalid for practice.

29.14(3) A permit that has been lapsed may be reinstated upon submission of a new application for a permit in compliance with the provisions of this chapter and payment of the application fee as specified in 650—Chapter 15.

650—29.15(147,153,272C) Grounds for nonrenewal. A request to renew a permit may be denied on any of the following grounds:

29.15(1) After proper notice and hearing, for a violation of these rules or Iowa Code chapter 147, 153, or 272C during the term of the last permit renewal.

29.15(2) Failure to pay required fees.

29.15(3) Failure to obtain required continuing education.

29.15(4) Failure to provide documentation of current ACLS or PALS certification.

29.15(5) Failure to provide documentation of maintaining a properly equipped facility.

29.15(6) Receipt of a certificate of noncompliance from the college student aid commission or the child support recovery unit of the department of human services in accordance with 650—Chapter 33 or 650—Chapter 34.

650—29.16(153) Noncompliance. Violations of the provisions of this chapter may result in revocation or suspension of the dentist's permit or other disciplinary measures as deemed appropriate by the board.

These rules are intended to implement Iowa Code sections 153.13, 153.33, and 153.33B.

[Filed 6/19/19, effective 8/21/19]

[Published 7/17/19]

Editor's Note: For replacement pages for IAC, see IAC Supplement 7/17/19.