NEW JERSEY REGISTER
VOLUME 34, NUMBER 14
MONDAY, JULY 15, 2002
RULE PROPOSAL

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
NEW JERSEY STATE BOARD OF DENTISTRY
PARENTERAL CONSCIOUS SEDATION


Proposed Amendment: N.J.A.C. 13:30-8.2

Authorized By: New Jersey State Board of Dentistry, Kevin B. Earle, Executive Director.

Authority: N.J.S.A. 45:6-1 and 45:1-15.1.
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2002-237.

Submit comments by September 13, 2002 to:

Kevin B. Earle, Executive Director

New Jersey State Board of Dentistry

124 Halsey Street

PO Box 45005

Newark, New Jersey 07101

The agency proposal follows:

Summary

Pursuant to its general rulemaking authority, N.J.S.A. 45:1-15.1, the New Jersey State Board of Dentistry (the Board) proposes various amendments to N.J.A.C. 13:30-8.2, which sets forth requirements for the proper administration of parenteral conscious sedation (PCS) by licensed dentists. The Board proposes to amend N.J.A.C. 13:30-8.2 in order to make the requirements of the rule more consistent with the American Dental Association (ADA) guidelines on the use of PCS and with the PCS regulations promulgated by a majority of states.

N.J.A.C. 13:30-8.2(d) currently requires a licensed dentist who wishes to obtain a permit to administer PCS to submit proof that he or she has completed a minimum of 100 hours of didactic training and 100 hours of clinical training in the administration of PCS. The Board believes that because the current rule does not specify what the required didactic and clinical training must encompass, the rule does not provide licensees and administrators of PCS training programs with sufficient guidance as to appropriate training program content. In an effort to clarify the existing rule, the Board undertook a thorough review of ADA guidelines on PCS administration, as well as the regulations governing PCS administration in at least 40 states. Based upon its review, the Board has determined that the current training standard established in N.J.A.C. 13:30-8.2(d) is inconsistent with the training requirements supported by the ADA and implemented in a majority of states.

The PCS guidelines issued by the ADA provide that proper training in PCS administration requires a minimum of 60 hours of comprehensive coursework in PCS and additional laboratory experience. The ADA guidelines also state that proper training should include the supervised management by the PCS trainee of at least 20 patients who have been administered PCS. A dentist being trained in the administration of PCS must achieve competency in numerous areas before such training is deemed complete.

The Board notes that currently most PCS programs offered by academic institutions or hospitals are structured to adhere to these ADA guidelines. However, applicants who complete such programs and establish their competency in PCS administration are required, nevertheless, to take additional course and clinical work that is repetitive, in order to satisfy the current requirements in N.J.A.C. 13:30-8.2(d). The Board does not believe that this requirement serves a beneficial purpose. Rather, the Board believes that the competency- based training standard supported by the ADA is more appropriate than the standard currently articulated in N.J.A.C. 13:30-8.2(d), and that once implemented in New Jersey, it will help to ensure that only those dentists who receive proper training will be permitted to administer PCS.

The Board is proposing to amend N.J.A.C. 13:30-8.2(d) to require an applicant for a PCS permit to submit a certification from an accredited university, teaching hospital or training institution, which establishes that the applicant has completed formal training in the administration of PCS. Formal PCS training must consist of a combined 80 hours in didactic instruction and supervised clinical training. The supervised clinical training must include delivering intravenous, intramuscular, subcutaneous, submucosal and inhalation medications, monitoring patient activity, and managing patient care for at least 20 patients who have been administered PCS. As part of the applicant's submission, the institution must certify that the applicant is competent to perform all functions associated with the administration of PCS. The Board believes that a combined 80 hours of instruction, along with the requisite certification of competency from the institution, will be sufficient to ensure that applicants are properly trained. The Board believes that requiring a combined 80 hours of instruction, as opposed to 60 hours of didactic training with additional clinical work, will allow academic institutions and hospitals greater flexibility in structuring their PCS programs. The academic institutions and hospitals, the Board believes, will ensure that such programs fall within the parameters established by the ADA guidelines.

In addition to the proposed amendments to the training requirements of subsection (d), the Board is also proposing amendments to the minimum equipment requirements outlined in N.J.A.C. 13:30-8.2(g). Subsection (g), which currently requires PCS permit holders to certify that their facilities contain certain emergency equipment, is amended to require each permit holder to ensure that his or her facility includes an EKG monitor and a pulse oximeter, in addition to the equipment currently required. The Board is proposing to require that the facility also be equipped with back-up, battery-operated lighting, suction and pulse oximetery equipment, which must be readily accessible and properly operating. The Board believes that the proposed amendments will help to ensure that permit holders have basic equipment and supplies available when administering PCS to adequately protect patients should an emergency situation arise.

The Board is also proposing a new subsection (j) in order to clarify the requirements imposed upon the holder of a PCS permit who administers PCS in the dental facility of another Board licensee. The Board proposes this amendment in response to concerns among many in the regulated community that permit holders who provide itinerant PCS services should have their mobile equipment and supplies inspected in the same manner as do permit holders who provide their services in one facility. Proposed new subsection (j) provides that any permit holder who is invited by a dentist to provide PCS services in a dental facility will be responsible for compliance with minimum assisting staff and equipment requirements. Existing subsections (j), (k) and (l) are recodified as subsections (k), (l) and (m).

For similar safety reasons, the Board is proposing to amend subsection (c) in order to clarify for permit holders who have branch offices that they must obtain a PCS permit for each branch office or facility in which they administer PCS. Except in the case of itinerant PCS providers, a PCS permit must be issued for a specified practice location. The Board proposes this amendment in order to ensure that each facility in which a permit holder administers PCS is properly equipped and staffed so as to provide the highest level of patient care.

The Board also proposes to amend N.J.A.C. 13:30-8.2(e) and (f) which provide that a PCS permit holder and his or her assisting staff, respectively, must complete the Basic Life Support Course C offered by the American Heart Association. The proposed amendment provides permit holders and their assisting staff with the option of taking either the basic life support course or a course in Advanced Cardiac Life Support. The Board believes that both courses are acceptable and proposes this amendment in order to provide permit holders and their staff with greater flexibility in their choice of training.

The Board proposes technical amendments to the remaining sections of N.J.A.C. 13:30-8.2 in order to clarify the existing requirements of the rule. Specifically, the Board proposes technical amendments to existing subsections (a), (b), (h) and (i), and recodified subsections (k), (l) and (m), for clarification purposes. The Board is proposing to delete existing subsection (m), which provides that a licensee who administers PCS without a permit will be deemed to have engaged in occupational misconduct, because the provision is duplicative of N.J.A.C. 13:30-1.1(c), which provides that a violation of any Board rule may be deemed professional misconduct and may subject a licensee to disciplinary action. The Board has determined that the comment period for this proposal shall be 60 days; therefore, pursuant to N.J.A.C. 1:30-3.3(a)5, this proposal is excepted from the rulemaking calendar requirement.

Social Impact

The Board believes that the proposed amendments to N.J.A.C. 13:30-8.2 will have a positive impact upon licensees and the patients they serve. The proposed amendments to N.J.A.C. 13:30-8.2(c), which will require a permit holder who has multiple offices to obtain a PCS permit for each branch office or facility in which he or she administers PCS, will ensure that each facility will be properly equipped and staffed. In addition, the Board believes that the new training requirements proposed in subsection (d) will help to ensure that only those applicants who have fulfilled the educational requirements of a structured PCS training program, and have been certified as competent in all areas of PCS administration, will be granted permits to administer PCS.

The Board also believes that the proposed amendments to subsection (g), which require a PCS permit holder to maintain an EKG monitor, a pulse oximeter, and additional battery-operated, back-up equipment at the facility where PCS will be administered, will ensure that PCS permit holders are appropriately equipped to deal with emergency situations. The requirements of recodified subsection (j) will also have a positive impact upon patients by ensuring that PCS permit holders who are providing PCS services in one or more dental facilities will comply with the minimum requirements imposed by the Board as to assisting staff and equipment, regardless of the number of facilities in which they provide their services. In addition, recodified subsection (j) will also positively impact patients by ensuring that the mobile equipment and supplies of the itinerant PCS provider are inspected and approved by the Board or its designee once every three years.

Economic Impact

The Board believes that the proposed amendments to N.J.A.C. 13:30-8.2(c) may have an economic impact upon applicants for PCS permits and current PCS permit holders to the extent that applicants and permit holders may incur administrative expenses associated with submitting applications, complete with any required documentation, for each branch office or facility in which the licensee will administer PCS. In addition, the proposed amendments to subsection (d) may have an economic impact upon applicants for PCS permits to the extent that such licensees will have to satisfy the training requirements outlined in subsection (d) prior to being granted a PCS permit. The Board believes that the costs associated with satisfaction of the required training will vary depending upon which university, teaching hospital or training institution a licensee chooses to attend in order to obtain the requisite training. Licensees, once they have been granted a PCS permit, will also incur the added expense associated with obtaining emergency life support training on a biennial basis. The proposed amendments to N.J.A.C. 13:30-8.3(g) may also have an economic impact upon applicants for PCS permits to the extent that they will incur costs associated with purchasing the required safety equipment and supplies. In addition, the Board believes that the proposed amendments to subsection (g) may have an economic impact upon current PCS permit holders to the extent that permit holders may have to purchase the new equipment and supplies that will now be required to be maintained in a dental office in which PCS is administered. The Board cannot estimate the costs that may be incurred by new PCS permit holders or by current PCS permit holders in terms of the equipment and supplies that must be purchased because such costs will vary depending on the type of equipment and supplies licensees choose to purchase in order to satisfy the requirements of the rule.

The Board believes that any economic impact that may be borne by PCS permit holders as a result of the proposed amendments will be outweighed by the benefit to patients in ensuring that PCS permit holders are appropriately trained and properly equipped to administer PCS.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments to N.J.A.C. 13:30-8.2 are governed by N.J.S.A. 45:6-1 et seq., and are not subject to any Federal standards or requirements.

Jobs Impact

The Board does not believe that the proposed amendments to N.J.A.C. 13:30- 8.2 will result in the creation or the loss of any jobs in the State. It is possible, however, that the proposed amendments to N.J.A.C. 13:30-8.2(d), which will decrease the number of training hours that an applicant for a PCS permit must complete, may result in an increase in the number of applicants for such permits. The Board, however, cannot anticipate at this time what impact, if any, the proposed amendments will have on the number of jobs available for PCS permit holders, because such impact will vary depending on the number of licensees who seek PCS permits in the future.

Agriculture Industry Impact

The Board does not believe that the proposed amendments will have any impact on the agriculture industry in the State.

Regulatory Flexibility Analysis

The Regulatory Flexibility Act (the Act), N.J.S.A. 52:14B-16 et seq., requires the Board to provide a description of the types and an estimate of the number of small businesses to which the proposed amendments will apply. Currently, the Board licenses approximately 9,616 dentists. If these Board licensees are considered "small businesses" within the meaning of the Act, then the following analysis applies.

The Act requires the Board to set forth the reporting, recordkeeping and other compliance requirements of the proposed amendments, including the kinds of professional services likely to be needed to comply with the requirements. The Act further requires the Board to estimate the initial and annual compliance costs of the proposed amendments, to outline the manner in which it has designed the proposed amendments to minimize any adverse economic impact upon small businesses, and to set forth whether the proposed amendments establish differing compliance requirements for small businesses.

The proposed amendments do not impose any reporting requirements upon Board licensees. N.J.A.C. 13:30-8.2(k) imposes recordkeeping requirements upon licensees to the extent that licensees must retain a patient's complete medical history, obtained prior to the administration of PCS, for at least seven years.

The existing provisions of N.J.A.C. 13:30-8.2, as well as the proposed amendments, will impose various compliance requirements upon Board licensees. N.J.A.C. 13:30-8.2(a) requires licensees administering PCS to satisfy all requirements outlined in N.J.A.C. 13:30-8.2. N.J.A.C. 13:30-8.2(c) prohibits a dentist from administering PCS unless he or she possesses a PCS permit. Subsection (c) also requires that a dentist obtain a separate PCS permit for each practice location where PCS is to be administered.

N.J.A.C. 13:30-8.2(d) requires a licensee applying for a PCS permit to submit a completed application to the Board. The application must contain a certification from an accredited university, teaching hospital or other training institution or facility, establishing that the applicant has completed formal training in the administration of PCS. As part of this training, the applicant for a PCS permit must have completed a combined 80 hours of didactic instruction and supervised clinical training in the administration of PCS. The supervised clinical training must have included the management of patient care for a minimum of 20 PCS patients. N.J.A.C. 13:30-8.2(d) also requires that this formal training have been completed within three years preceding the date of application. The certification submitted by the applicant's training facility must specify that the applicant is competent to: evaluate the medical status of patients and perform management assessments; understand and evaluate the effects of conscious sedation agents on patients; perform venipunctures and maintain intravenous access during PCS procedures; recognize and manage complications from drug administrations; understand the clinical pharmacology and interactions of the drugs used for PCS; maintain patient airways and support ventilation; monitor patients during the administration of PCS; recognize and manage anesthetic and medical emergencies arising from the use of PCS; manage patients during the post-operative period; and maintain accurate records.

N.J.A.C. 13:30-8.2(e) requires all applicants for PCS permits to obtain emergency training by completing the American Heart Association's Basic Life Support Course C, or its equivalent, or a course in Advanced Cardiac Life Support, or its equivalent. N.J.A.C. 13:30-8.2(f) requires all applicants for PCS permits to certify upon their application, and upon permit renewal, that the dentist employs no fewer than two persons who will be present in the office when PCS is administered. The applicant must also certify that such employees are appropriately trained in basic life support or advanced cardiac life support.

N.J.A.C. 13:30-8.2(g) requires all applicants for PCS permits to certify as part of their initial application, and upon renewal, that they possess basic equipment and supplies, which are readily accessible and properly operating. The facilities must contain, at a minimum, an emergency drug kit, positive pressure oxygen, a stethoscope, suction, nasopharyngeal tubes, oropharyngeal tubes, a blood pressure monitoring device, an EKG monitor and a pulse oximeter. The permit holder's facility must also contain back-up, battery-operated lighting, suction and a pulse oximeter.

N.J.A.C. 13:30-8.3(i) requires a PCS permit holder who administers PCS at the office of another dentist to remain present during the administration of PCS and retain full responsibility for the procedure until the patient has fully recovered and has been discharged. N.J.A.C. 13:30-8.2(j) requires a PCS permit holder who administers PCS at the office of another dentist to ensure that minimum requirements for assisting staff and equipment are satisfied. In addition, subsection (j) also requires that the mobile equipment and supplies of such permit holders be inspected once every three years. N.J.A.C. 13:30-8.2(l) requires all PCS permit holders to certify, upon biennial renewal, that they have completed at least 20 credits of continuing education in PCS.

No additional professional services will be needed to comply with the proposed amendments. The costs of compliance with the proposed amendments are discussed in the Economic Impact statement above. The Board believes that the proposed amendments should be uniformly applied to all PCS permit holders in order to ensure the health, safety and welfare of the general public in the administration of PCS and, therefore, no differing compliance requirements for any permit holder are provided based upon size.

Smart Growth Impact

The Board does not believe that the proposed amendments will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Full text of the proposal follows:

<< NJ ADC 13:30-8.2 >>

13:30-8.2 Parenteral conscious sedation

(a) <<-The use of parenteral conscious sedation (hereinafter referred to as "PCS") by a dentist without first having met the minimum standards of training and procedure as stated herein shall constitute a deviation from the normal standards of practice required of a licensee.->> <<+No dentist shall administer parenteral conscious sedation ("PCS") unless the minimum standards of training and procedure set forth in this section are satisfied.+>>

(b) <<-Parenteral conscious sedation->> <<+PCS+>> is defined as a depressed level of consciousness produced by the parenteral administration of pharmacologic substances that <<-retains->> <<+allows+>> the patient<<-'s->> <<+to retain the+>> ability to independently and continuously maintain an airway and respond appropriately to physical stimulation or verbal command. This modality includes administration of medications via all parenteral routes, that is, intravenous, intramuscular, subcutaneous, submucosal, or inhalation, but does not include nitrous-oxide inhalation analgesia.

(c) No dentist shall use PCS for dental patients unless such dentist possesses a PCS permit issued by the State Board of Dentistry<<-. The dentist holding such permit shall be subject to review, and such permit->> <<+for a specified practice location which+>> shall be renewed biennially. <<+A dentist shall obtain a separate PCS permit for each practice location at which PCS is administered, except as set forth in (j) below.+>>

(d) <<-Any->> <<+A+>> dentist <<-who wishes to obtain->> <<+ applying for+>> a Board permit to <<-employ->> <<+administer+>> PCS shall complete an application as provided by the Board <<-office and shall provide certified or verifiable proof that the dentist has completed a minimum of 100 hours of continuing education in didactic training and 100 hours in clinical training in PCS within thee years preceding the application->>. <<+The dentist shall submit as part of a completed application a certification from an accredited university, teaching hospital or other training institution or facility approved pursuant to N.J.S.A. 45:6-2, establishing that the applicant has completed formal training in the administration of PCS. Such formal training shall consist of, at a minimum, a combined 80 hours in didactic instruction and supervised clinical training in the administration of PCS. Such formal training shall have been completed within three years preceding the date of application. Supervised clinical training shall consist of, at a minimum, delivering intravenous, intramuscular, subcutaneous, submucosal and inhalation medications, monitoring patient activity and managing patient care for 20 PCS patients. As part of the dentist's PCS permit application, the institution shall certify the applicant is competent to:+>>

<<+1. Evaluate the medical status of patients and perform risk management assessments according to American Society of Anesthesiology (ASA) Classification by use of patient histories, physical examinations, vital signs, and pertinent laboratory data and information obtained by medical consultations, and that the applicant can modify treatment plans accordingly;+>>

<<+2. Understand and evaluate the effects of conscious sedation agents on the medical, physical and psychological status of patients;+>>

<<+3. Perform venipunctures and maintain intravenous access during PCS procedures;+>>

<<+4. Recognize and manage complications from drug administrations;+>>

<<+5. Understand the clinical pharmacology and interactions of the drugs used for PCS;+>>

<<+6. Maintain patient airways and support ventilation;+>>

<<+7. Monitor patients during the administrationof PCS using clinical evaluations and mechanical means including the use of an EKG monitor and a pulse oximeter and the interpretation of such readings;+>>

<<+8. Recognize and manage anesthetic and medical emergencies arising from the use of PCS;+>>

<<+9. Manage patients during the post-operative period and assess patients' suitability for discharge; and+>>

<<+10. Maintain accurate anesthetic records including drug dosages, vital signs and patient responses.+>>

(e) <<-Every->> <<+An+>> applicant for a <<+PCS+>> permit <<-to use PCS->> shall obtain emergency training by completing "Basic Life Support: Course C" of the American Heart Association or its equivalent <<+or a course in Advanced Cardiac Life Support or its equivalent+>> and shall maintain current certification in <<-the->> <<+such+>> course. The applicant shall furnish proof of this training and certification to the Board upon application for a <<+PCS+>> permit and proof of recertification upon biennial renewal of the permit.

(f) <<-Every->> <<+An+>> applicant for a <<+PCS+>> permit <<-to use PCS additionally->> shall certify to the Board <<+upon application for a permit and upon biennial renewal of the permit+>> that the dentist employs no fewer than two persons who will be present in the office, at least one of whom <<-will->> <<+shall+>> assist in monitoring the patient whenever PCS is employed. The applicant shall further certify that these persons are trained in and capable of monitoring vital signs and of assisting in emergency procedures and that they maintain current certification in "Basic Life Support: Course C" or its equivalent <<+or in Advanced Cardiac Life Support or its equivalent+>>.

(g) <<-Every->> <<+An+>> applicant for a <<+PCS+>> permit <<-to use PCS->> shall certify as part of the application <<+for a permit and upon biennial renewal of the permit+>> that he or she possesses basic equipment and supplies to deal with emergency situations. The permit holder's facility shall contain the following readily accessible and properly operating equipment: emergency drug kit; positive pressure oxygen; stethoscope; suction; nasopharyngeal tubes; oropharyngeal tubes; <<-and->> a blood pressure monitoring device<<+; an EKG monitor; and a pulse oximeter or its equivalent+>>. <<+The permit holder's facility shall also contain back-up, battery-operated equipment consisting of, at a minimum, lighting, suction and a pulse oximeter, which shall be readily accessible and properly operating+>>.

(h) <<-Any->> <<+A+>> licensee who holds a current general anesthesia permit issued by the Board of Dentistry shall be authorized to use PCS and shall not be required to <<-make application->> <<+apply+>> for a <<+ PCS+>> permit pursuant to this section.

(i) <<-Any->> <<+A+>> dentist who utilizes the services of a PCS permit holder or an M.D. or D.O. <<-who is a member of the anesthesiology staff of an accredited hospital->> <<+who is authorized to perform anesthesia services by the Board of Medical Examiners pursuant to N.J.A.C. 13:35-4A.1+>> shall not be deemed to be <<-practicing->> <<+ administering+>> PCS, provided that <<-such->> <<+the PCS+>> permit holder or anesthesiologist <<-must->> remain<<+s+>> present <<+during the administration of PCS+>> and bears full responsibility during the entire procedure <<-and->> until <<-any->> <<+the+>> patient has recovered fully and has been <<-dismissed->> <<+discharged+>>. <<-Any permit holder invited by a dentist to provide PCS services shall bear full responsibility for compliance with all terms and conditions of this rule including, but not limited to, the minimum requirements for equipment and assisting staff.->>

<<+(j) A PCS permit holder invited by a dentist to provide PCS services at a specific location shall bear full responsibility for compliance with all provisions of this section including the minimum requirements for assisting staff and equipment set forth in (f) and (g) above. When a PCS permit holder utilizes mobile equipment and supplies to administer PCS pursuant to this section, the mobile equipment and supplies of the permit holder shall be inspected by the Board or its designee not less than once every three years. "Mobile equipment and supplies," for purposes of this subsection, means any equipment and/or supplies which are transported and used by a permit holder to administer PCS in one or more locations. When more than one permit holder utilizes the mobile equipment and supplies, it shall be the responsibility of the permit holder using the equipment and supplies to ensure that the mobile equipment and supplies satisfy the requirements of this section as set forth in (g) above prior to the administration of PCS.+>>

<<-(j)->><<+(k) +>>Prior to the administration of a PCS agent for the purpose of controlling pain, a physical evaluation <<+of the patient+>> shall be made by the permit holder and a complete medical history shall be obtained which shall include previous medications, allergies and sensitivities. <<-Said->> <<+The patient+>> history shall be maintained in the files of each dentist for a period of not less than seven years. Specific records on the use of PCS shall be kept as part of every patient chart and shall include the type of agent, the dosage<<+,+>> and the duration of sedation.

<<-(k)->><<+(l) +>><<-Every->> <<+A+>> licensee who holds a PCS permit shall <<-present satisfactory proof->> <<+certify+>> to the Board upon biennial renewal that the holder has completed a least 20 <<- credit->> hours during the previous two-year period in continuing education courses devoted to PCS <<-and presented by an accepted program in a suitable institution. Satisfactory credit hours to fulfill this continuing education requirement may be obtained from the following:->> <<+consistent with the requirements set forth in N.J.A.C. 13:30-5.1.+>>

<<-1. Professional service review organizations;->>

2. Teaching;

3. Lectures;

4. Seminars; or

5. Other methods approved by the Board.<<-->>

<<-(l)->><<+(m) +>>Any designee of the Board shall be authorized during ordinary business hours to enter and inspect any dental office <<+or mobile equipment and supplies+>> for the purpose of enforcing the provisions of this rule.

<<-(m) Any licensee who administers PCS without first having obtained a permit from the Board or any licensee who fails to comply with the rules set forth herein, shall be deemed to have engaged in professional misconduct and/or gross malpractice or negligence and may be subjected to appropriate disciplinary action including an action for the suspension or revocation of the licensee's license to practice dentistry in the State of New Jersey.->>



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