02 department of professional and financial regulation 313 maine state board of dental examiners chapter 14: rules for use of sedation and general anesthesia by dentists summary



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02 DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION
313 MAINE STATE BOARD OF DENTAL EXAMINERS
Chapter 14: RULES FOR USE OF SEDATION AND GENERAL ANESTHESIA BY DENTISTS

Summary: This rule prescribes the circumstances under which dentists may administer Minimal, Moderate, and Deep Sedation and General Anesthesia in the State of Maine.


I. ADOPTION OF THE ADA GUIDELINES FOR THE USE OF SEDATION AND GENERAL ANESTHESIA BY DENTISTS.
The Board adopts and incorporates into this Chapter by reference the American Dental Association’s “Guidelines for the Use of Sedation and General Anesthesia by Dentists” (as adopted by the October 2007 ADA House of Delegates)[hereinafter referred to in these rules as “ADA Sedation Guidelines”]. All Dentists shall comply with the “ADA Sedation Guidelines” in addition to any other requirement imposed by the Board pursuant to this Chapter. In the event of a conflict between a standard in the “ADA Sedation Guidelines” and a provision of this Chapter, the provision of this Chapter shall govern.
Copies of the ADA “Guidelines for the Use of Sedation and General Anesthesia by Dentists” (as adopted by the October 2007 ADA House of Delegates) are available at:
American Dental Association
211 East Chicago Ave.
Chicago, IL 60611-2678
312-440-2500
The electronic version may be accessed on line at:
www.ada.org/sections/professionalResources/pdfs/anesthesia_guidelines.pdf

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II. ADOPTION OF THE ADA GUIDELINES FOR THE USE OF SEDATION AND GENERAL ANESTHESIA BY DENTISTS
The Board adopts and incorporates into this Chapter by reference the American Dental Association’s “Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (as adopted by the October 2007 ADA House of Delegates). [hereinafter referred to in these rules as “ADA Teaching Guidelines”]. All Dentists shall comply with the “ADA Teaching Guidelines” in addition to any other requirement imposed by the Board pursuant to this Chapter. In the event of a conflict between a standard in the “ADA Teaching Guidelines” and a provision of this Chapter, the provision of this Chapter shall govern.
Copies of the ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students” (as adopted by the October 2007 ADA House of Delegates) are available at:
American Dental Association
211 East Chicago Ave.
Chicago, IL 60611-2678
312-440-2500
The electronic version may be accessed on line at:
www.ada.org/sections/professionalResources/pdfs/anxiety_guidelines.pdf

III. PERMITS REQUIRED. No dentist may administer moderate sedation or deep sedation/general anesthesia to any person without first being issued a permit by the Board. A dentist issued a Permit for Moderate Sedation Level II (Parenteral) by the Board may also perform moderate sedation level I (enteral) and minimal sedation. A dentist issued a Permit for Deep Sedation/ General Anesthesia by the Board may also perform any type of moderate or minimal sedation.


  1. Posting of Permits. All dentists who have been issued a permit pursuant to this Chapter are required to post such permit within the dental practice in an area that is accessible to the public.

B. Minimal Sedation


(1) General. No dentist shall be required to obtain a permit in order to administer minimal sedation as defined by the “ADA Guidelines.”
(2) Exception. Dentists who administer minimal sedation to patients age 12 and under require a Permit for Moderate Sedation, which sedation may only be administered to the child inside the dental office, if:
(a) The dentist prescribes a preoperative sedative to be administered to the child (Level I – Enteral); or
(b) The dentist administers a combination of minimal sedation methods (i.e. oral sedative and nitrous oxide)(Level I – Enteral).
C. Moderate Sedation
(1) Permit Required. No dentist shall employ or use moderate sedation as defined by the “ADA Guidelines” on an outpatient basis for dental patients, unless such dentist possesses a “Permit for Moderate Sedation” issued by the Maine Board of Dental Examiners (The Board).
(2) Duration of Permits. Permits issued by the Board pursuant to this rule shall not exceed five (5) years in duration, and must be renewed in order for the dentist to continue to perform moderate sedation. Dentists holding such permits shall be subject to review of their education, training, and office equipment and procedures at the discretion of the Board.
(3) Method of Obtaining Permits. In order to receive such permits, dentists must apply on a prescribed application form to the Board, submit a permit application fee of $500.00, and meet the educational and training requirements established by this Chapter for the type of permit requested.
(4) Types of Permits for Moderate Sedation: The Board shall issue two types of permits for moderate sedation:
(a) Permit for Moderate Sedation Level I (Enteral); and
(b) Permit for Moderate Sedation Level II (Parenteral).
(5) Qualifications for Permits for Moderate Sedation: In order to obtain a Permit for Moderate Sedation, applicants must meet the following educational and training criteria established for the type of permit for which he/she applies:
(a) Permit for Moderate Sedation Level I (Enteral). Applicants for this type of permit must:
(i) Have successfully completed a Board-approved comprehensive training program of a minimum of twenty-four (24) hours duration, plus management of at least ten (10) adult case experiences by the enteral and/or enteral-nitrous oxide/oxygen route as described in the “ADA Teaching Guidelines.” The ten (10) cases must include at least three live clinical dental experiences managed by participants in groups no larger than five (5). The remaining cases may include simulations and/or video presentations, but must include one experience in returning (rescuing) a patient from deep to moderate sedation. Participants should be provided supervised opportunities for clinical experience to demonstrate competence in airway management. Clinical experience will be provided in managing healthy adult patients. This course in moderate enteral sedation is not designed for the management of children (aged 12 and under). Additional supervised clinical experience is necessary to prepare participants to manage medically compromised adults and special needs patients. This course in moderate enteral sedation does not result in competency in moderate paraenteral sedation.
Waiver: The Board may waive the educational and training requirements established by this section for any dentist who holds a current and unrestricted Maine dental license and who executes an affidavit on a form developed by the Board attesting that the dentist has a minimum of five (5) patient experiences utilizing “moderate sedation” (as defined by the ADA Guidelines as adopted by the October 2007 ADA House of Delegates) within the previous three (3) years prior to the enactment of this rule. Any application for a waiver under this section must be made within one (1) year of the enactment of this rule.
(ii) Possess a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course; and
(iii) Have successfully completed an on-site facility, equipment, personnel, procedures, techniques and documents inspection by the Anesthesia Subcommitee, a subcommittte established by this Chapter whose membership is appointed by the Board to act as its agent(s) in performing these inspections. In performing the on-site facility inspections, the Anesthesia Subcommittee shall employ the “ADA Sedation Guidelines.” In the case of a mobile or portable facility, one inspection of that facility shall be conducted in the office of a Maine licensed dentist where sedation is administered. The applicant/dentist shall provide the Anesthesia Subcommittee with a written statement that includes a list of all monitors, emergency equipment and other materials, which the mobile sedation provider agrees to have available at all times while administering sedation in multiple locations. This evaluation may also include the observance of at least one actual or simulated procedure where the general anesthetic or sedation techniques are employed. Hospitals licensed by the State of Maine are exempt from an on-site facility and equipment inspection.
(b) Permit for Moderate Sedation Level II (Parenteral). Applicants for this type of permit must:
(i) Have successfully completed a Board-approved comprehensive training program of a minimum of sixty (60) hours of instruction, plus management of at least 20 patients by the intravenous route per participant as described in the “ADA Teaching Guidelines.” Clinical experience in managing a compromised airway is critical to the prevention of emergencies. Participants should be provided supervised opportunities for clinical experience to demonstrate competence in management of the airway. Typically, clinical experience will be provided in managing healthy adult patients. Additional supervised clinical experience is necessary to prepare participants to manage children (aged 12 and under) and medically compromised adults.
Waiver: The Board may waive the educational and training requirements established by this section for any dentist who holds a current and unrestricted Maine dental license and who executes an affidavit on a form developed by the Board attesting that the dentist has a minimum of five (5) patient experiences utilizing “moderate sedation” (as defined by the ADA Guidelines as adopted by the October 2007 ADA House of Delegates) within the previous three (3) years prior to the enactment of this rule. Any application for a waiver under this section must be made within one (1) year of the enactment of this rule.
(ii) Possess a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course; and
(iii) Have successfully completed an on-site facility, equipment, personnel, procedures, techniques and documents inspection by the Anesthesia Subcommitee, a subcommittte established by this Chapter whose membership is appointed by the Board to act as its agent(s) in performing these inspections. In performing the on-site facility inspections, the Anesthesia Subcommittee shall employ the “ADA Sedation Guidelines.” In the case of a mobile or portable facility, one inspection of that facility shall be conducted in the office of a Maine licensed dentist where sedation is administered. The applicant/dentist shall provide the Anesthesia Subcommittee with a written statement that includes a list of all monitors, emergency equipment and other materials, which the mobile sedation provider agrees to have available at all times while administering sedation in multiple locations. This evaluation may also include the observance of at least one actual or simulated procedure where the general anesthetic or sedation techniques are employed. Hospitals licensed by the State of Maine or CODA accredited clinical settings are exempt from an on-site facility and equipment inspection.
(c) Temporary Permit for Moderate Sedation. The Board may issue a Temporary Permit for Moderate Sedation Level I or Level II. Temporary permits are nonrenewable and may not exceed six (6) months duration. To be eligible to receive a temporary permit, an applicant must show proof satisfactory to the Board that:
(i) He/she has successfully completed a comprehensive training program as described in the “ADA Teaching Guidelines” that is commensurate with the level of temporary permit for moderate sedation sought;
(ii) He/she possesses a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course; and
(iii) He/she has scheduled but not undergone an on-site facility, equipment, personnel, procedures, techniques and documents inspection by the Anesthesia Subcommitee.
(6) Renewal of Permit for Moderate Sedation. The Board may renew a permit if the following criteria are met:
(a) The Board receives an application to renew the permit;
(b) An on-site re-evaluation has been successfully completed by the Anesthesia Subcommittee within one (1) year prior to permit renewal;
(c) The applicant has completed a minimum of six (6) continuing education hours biannually directly related to anesthesia/sedation, physical diagnosis, complications, techniques, A.C.L.S. and B.C.L.S;
(d) The applicant possesses a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course;
(e) The applicant pays the $500.00 permit renewal fee; and
(f) There are no other grounds to deny the renewal of the permit.
(7) Board Access to Dental Practice. By applying for and obtaining a permit for moderate sedation from the Board, an applicant or permitee agrees to allow the Board or its agent(s) access to his/her dental practice in order to inspect and evaluate the facility, equipment, personnel, procedures, techniques and documents to ensure that they comply with the “ADA Sedation Guidelines.” The Board, in its discretion, may perform random quality assurance audits, which may include, but are not limited to, a review of documentation of pre-sedation evaluations, sedation and recovery records, and documentation of appropriateness for discharge. The permit holder shall be responsible for the actual costs incurred in a formal reevaluation, not to exceed two hundred dollars.
(8) Permits are Site Specific. All moderate permits are site specific and cannot be relocated to or extended to another site without site approval and a new permit issued by the Board.


  1. Deep Sedation and General Anesthesia

(1) Permit Required. No dentist shall employ or use deep sedation or general anesthesia as defined by the “ADA Guidelines” on an outpatient basis for dental patients, unless such dentist possesses a “Permit for Deep Sedation/General Anesthesia” issued by the Maine Board of Dental Examiners (The Board).


(2) Duration of Permits. Permits issued by the Board pursuant to this rule shall not exceed five (5) years in duration, and must be renewed in order for the dentist to continue to perform moderate sedation. Dentists holding such permits shall be subject to review of their education, training, and office equipment and procedures at the discretion of the Board.
(3) Method of Obtaining Permits. In order to receive a Permit for Deep Sedation/General Anesthesia, dentists must apply on a prescribed application form to the Board, submit an application fee of $500.00, and meet the educational and training requirements established by this Chapter.
(4) Qualifications for Permits for Deep Sedation/General Anesthesia: In order to obtain a Permit for Deep Sedation/General Anesthesia, dentist applicants must meet the following educational and training criteria:
(a) Have successfully completed an advanced education program accredited by the ADA Commission on Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary to administer and manage deep sedation or general anesthesia commensurate with Part IV.C of the “ADA Sedation Guidelines;”
(b) Possess a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course;
(c) Have a properly equipped facility for the administration of deep sedation or general anesthesia staffed with a supervised team of auxiliary personnel capable of reasonably handling procedures, problems, and emergencies as outlined in the “ADA Sedation Guidelines;” and
(d) Successfully completed an on-site facility, equipment, personnel, procedures, techniques and documents inspection by the Anesthesia Subcommitee, a subcommittte established by this Chapter whose membership is appointed by the Board to act as its agent(s) in performing these inspections. In performing the on-site facility inspections, the Anesthesia Subcommittee shall employ the “ADA Sedation Guidelines.” This evaluation may also include the observance of at least one actual or simulated procedure where the general anesthetic or sedation techniques are employed. Hospitals licensed by the State of Maine or CODA accredited clinical settings are exempt from an on-site facility and equipment inspection.
(5) Temporary Permit for Deep Sedation/General Anesthesia. The Board may issue a Temporary Permit for Deep Sedation/General Anesthesia to any applicant who meets the criteria established in sections (a) to (c) above, and have scheduled but not yet undergone an on-site inspection of his/her facility, equipment, personnel, procedures, techniques and documents inspection by the Anesthesia Subcommitee. Temporary permits for deep sedation/general anesthesia shall be nonrenewable and no more than six (6) months in duration.
(6) Renewal of Permit for Deep Sedation/General Anesthesia. The Board may renew a permit if the following criteria are met:
(a) The Board receives an application to renew the permit;
(b) An on-site re-evaluation has been successfully completed by the Anesthesia Subcommittee within one (1) year prior to permit renewal;
(c) The applicant has completed a minimum of six (6) continuing education hours biannually directly related to anesthesia/sedation, physical diagnosis, complications, techniques, A.C.L.S. and B.C.L.S;
(d) The applicant possesses a current certification in: (a) Basic Life Support for Healthcare Providers (BCLS); and (b) Advanced Cardiac Life Support (ACLS) or an appropriate dental sedation/anesthesia emergency management course;
(e) The applicant pays the $500.00 permit renewal fee; and
(f) There are no other grounds to deny the renewal of the permit.
(7) Board Access to Dental Practice. By applying for and obtaining a permit for deep sedation/general anesthesia from the Board, an applicant agrees to permit the Board or its agent(s) access to his/her dental practice in order to inspect and evaluate the facility, equipment, personnel, procedures, techniques and documents to ensure that they comply with the “ADA Sedation Guidelines.” The Board, in its discretion, may perform random quality assurance audits, which may include, but are not limited to, a review of documentation of pre-sedation evaluations, sedation and recovery records, and documentation of appropriateness for discharge. The permit holder shall be responsible for the actual costs incurred in a formal reevaluation, not to exceed two hundred dollars.
(8) Permits are Site Specific. All deep sedation/general anesthesia permits are site specific and cannot be relocated to or extended to another site without site approval and a new permit issued by the Board.

IV. STANDARD OF CARE


  1. Minimal Sedation. All dentists shall comply with the generally accepted standards as established by the “ADA Sedation Guidelines” for the administration of minimal sedation.

B. Moderate Sedation. All dentists administering moderate sedation shall:


(1) Comply with the generally accepted standards as established by the “ADA Sedation Guidelines” for the administration of moderate sedation; and
(2) Not have more than one patient under moderate sedation simultaneously with other patients in the dental office. EXEMPTION: A moderate sedation permittee may administer moderate sedation to no more than three patients within a Board-approved educational setting, for purposes of acting as an instructor.
C. Deep Sedation/General Anesthesia. All dentists shall comply with the generally accepted standards as established by the “ADA Sedation Guidelines” for the administration of deep sedation/general anesthesia. In addition, each permitted dentist administering deep sedation/general anesthesia:
(1) Must employ and document the use of continuous E.C.G. monitoring for all patients to whom deep sedation/general anesthesia is administered; and
(2) Must not have more than one patient under deep sedation/general anesthesia and/or moderate sedation simultaneously.

V. THE ANESTHESIA SUBCOMMITTEE


  1. General. The Board shall create an Anesthesia Subcommittee, which shall be comprised of at least three dental licensees who have successfully completed an advanced education program accredited by the ADA Commission on Dental Accreditation (CODA) that affords comprehensive and appropriate training necessary to administer and manage deep sedation or general anesthesia commensurate with Part IV.C of the “ADA Sedation Guidelines.”




  1. Authority. The Anesthesia Subcommittee is an agent of the Board created pursuant to 32 M.R.S. §1073(1) & (2) in order to facilitate the Board’s inspection of numerous dental facilities located throughout the State of Maine that administer moderate and deep sedation/general anesthesia. As agents of the Board, Anesthesia Subcommittee members shall be reimbursed for travel expenses incurred while performing any inspection required prior to the issuance of a permit for moderate or deep sedation/general anesthesia pursuant to this Chapter.




  1. Duties. The Anesthesia Subcommittee shall:

(1) Perform all on-site inspections of the facilities, equipment, personnel, procedures, techniques and documents of any applicant or permittee as required by this Chapter.


(2) Evaluate the applicant’s facility, equipment, personnel, procedures, techniques and documents employing the “ADA Sedation Guidelines.” This evaluation may also include the observance of at least one actual or simulated procedure where the general anesthetic or sedation techniques are employed.
(3) Create a written report of the evaluation following the inspection.
(4) Provide the Board and the applicant or permittee with a copy of the report of inspection.
(5) Perform any follow-up inspections of the facility, equipment, personnel, procedures, techniques and documents of any applicant or permittee as directed by the Board.
(6) At the discretion of the Board, perform random quality assurance audits of permittees, which may include, but are not limited to, a review of documentation of pre-sedation evaluations, sedation and recovery records, and documentation of appropriateness for discharge. The permit holder shall be responsible for the actual costs incurred in a formal reevaluation.
(7) Advise the Board on any issues involving moderate sedation or deep sedation/general anesthesia.
(8) Perform any other act not explicitly stated herein in the performance of its duties for the Board.



        1. BOARD ACTION




  1. Board Action Upon Receipt of Application. The Board staff shall ensure that the application is complete and that all paperwork has been completed and all fees remitted before processing an application for a permit. Once a completed application is received, the Board staff shall consult with the Board’s president or vice-president, who may decide, on behalf of the Board, to issue a temporary permit or full permit.




  1. Board Action Upon Receipt of Evaluation Report. In the event that the Board deems the inspection or evaluation unsatisfactory, a written explanation documenting deficiencies and suggested remedies shall be forwarded to the applicant or permittee within fourteen days. The Board may issue a permit based on documentation that deficiencies have been corrected; or the Board may require a formal evaluation; or the applicant or permittee may request an appearance before the Board to address the documented deficiencies.




  1. Board Action Upon Receipt of Adverse Event Report. In the event that the Board receives a report regarding any mortality or morbidity occurring in the out-patient facilities of a dentist, the Board may, in its discretion, investigate the circumstances surrounding the mortality or morbidity, including but not limited to a review of the dentists’ documentation of pre-sedation evaluations, and sedation and recovery records.



        1. PROHIBITED CONDUCT. No dentist, without personally obtaining the appropriate sedation permit, may employ or work in conjunction with a moderate or deep sedation/general anesthesia provider in an out-patient dental facility, unless he/she has met the requirements outlined below.



VIII. SITE PERMIT REQUIREMENTS. Failure to comply with the requirements of this section may result in disciplinary action against the operating dentist. If a licensed operating dentist intends to utilize the services of an appropriately permitted dentist, licensed physician anesthesiologist, or a certified registered nurse anesthetist, the licensed operating dentist utilizing an appropriately permitted dentist, licensed physician anesthesiologist or certified registered nurse anesthetist must meet the following requirements:
A. The sedation provider is a dentist holding a valid moderate or deep sedation/general anesthesia permit issued under this rule, provided that:
(1) The licensed operating dentist must submit to the Board a completed application indicating that moderate or deep sedation/general anesthesia services are provided at his or her facility by a licensed Maine dentist holding a current moderate or deep sedation/general anesthesia permit;
(2) The licensed operating dentist must provide the Board with the application/inspection fee;
(3) The dental facility has successfully completed a Board-approved facility inspection within six (6) months of the licensed operating dentist providing the Board with written notification that the moderate or deep sedation/general anesthesia services are provided at the facility by a permitted dentist, which inspection shall be repeated at intervals not to exceed five (5) years; and
(4) The licensed operating dentist ensures that the moderate or deep sedation/general anesthesia provider remains on the premises of the dental facility until any patient given moderate or deep sedation/general anesthesia has adequately recovered.
B. The sedation provider is a Maine-licensed physician who has successfully completed graduate medical education in the field of anesthesiology, as defined by the Maine Board of Licensure in Medicine, provided that:
(1) The licensed operating dentist must submit to the Board a completed application indicating that moderate or deep sedation/general anesthesia services are provided at his or her facility by a licensed Maine physician anesthesiologist holding a current certification in advanced cardiac life support whenever moderate or deep sedation/general anesthesia;
(2) The licensed operating dentist must provide the Board with the application/inspection fee; The moderate or deep sedation/general anesthesia provider, whether a dentist or physician, remains on the premises of the dental facility until any patient given moderate or deep sedation/general anesthesia has adequately recovered;
(3) The dental facility where the physician anesthesiologist will be providing moderate or deep sedation/general anesthesia has successfully completed a Board-approved facility inspection within six (6) months of the operating dentist providing the Board with written notification that the moderate or deep sedation/general anesthesia services are provided at the facility by a physician anesthesiologist, which inspection shall be repeated at intervals not to exceed five (5) years; and
(4) The licensed operating dentist ensures that the physician anesthesiologist providing moderate or deep remains on the premises of the dental facility until any patient given moderate or deep sedation/general anesthesia has adequately recovered.
C. The sedation provider is a Maine licensed certified registered nurse anesthetist, as defined by the Maine State Board of Nursing, provided that:
(1) The licensed operating dentist must submit to the Board a completed application indicating that moderate or deep sedation/general anesthesia services are provided at his or her facility by a licensed Maine certified registered nurse anesthetist holding a current certification in advanced cardiac life support whenever moderate or deep sedation/general anesthesia;
(2) The licensed operating dentist must provide the Board with the application/inspection fee;
(3) The dental facility where the certified registered nurse anesthetist will be providing moderate or deep sedation/general anesthesia has successfully completed a Board-approved facility inspection within six (6) months of the operating dentist providing the Board with written notification that the moderate or deep sedation/general anesthesia services are provided at the facility by a certified registered nurse anesthetist, which inspection shall be repeated at intervals not to exceed five (5) years; and
(4) The licensed operating dentist ensures that the certified registered nurse anesthetist providing moderate or deep sedation/general anesthesia remains on the premises of the dental facility until any patient given moderate or deep sedation/general anesthesia has adequately recovered.

IX. PENALTIES FOR VIOLATIONS. A violation of these rules pertaining to the use of Moderate or Deep Sedation/General Anesthesia shall constitute unprofessional conduct and may result in disciplinary action against the licensee.

STATUTORY AUTHORITY: 32 M.R.S.A. §§ 1073(2), 1089


EFFECTIVE DATE:

June 7, 1995


EFFECTIVE DATE (ELECTRONIC CONVERSION):

October 14, 1996


AMENDED:

May 21, 2005 – filing 2005-169

May 22, 2007 – filing 2007-205

February 11, 2009 – filing 2009-65

September 28, 2009 – filing 2009-503

June 27, 2010 – filing 2010-262



September 9, 2012 – filing 2012-256




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