[35 Pa.B. 2880]
[Continued from previous Web Page]
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 33. STATE BOARD OF DENTISTRY
Subchapter B. LICENSURE OF DENTISTS AND DENTAL HYGIENISTS § 33.110. Volunteer license.
(a) Purpose and definitions.
(1) The following subsections implement the Volunteer Health Services Act (35 P. S. §§ 449.41--449.50) and provide for the issuance of a volunteer license to a qualified individual who retires from active practice and seeks to provide professional services as a volunteer. A volunteer license authorizes the holder to practice only in an organized community-based clinic without remuneration.
(2) The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:
Approved clinic--
(i) An organized community-based clinic offering primary health care services to individuals and families who cannot pay for their care, to Medical Assistance clients or to residents of medically underserved areas or health professionals shortage areas.
(ii) The term includes a State health center, nonprofit community-based clinic and Federally qualified health center, as designated by Federal rulemaking or as approved by the Department of Health or the Department of Public Welfare.
Unrestricted license--A license which is not restricted or limited by order of the Board under its disciplinary power.
(b) License. A volunteer license may be issued to a licensee or certificateholder of the Board who documents to the satisfaction of the Board that the licensee will practice without personal remuneration in approved clinics and meets one of the following conditions:
(1) Holds a currently renewed, active, unrestricted license, registration or certificate in this Commonwealth and retires from active practice at the time the licensee applies for a volunteer license.
(2) Retires from the active practice of dentistry, or as a dental hygienist or as an expanded function dental assistant in this Commonwealth in possession of an unrestricted license, registration or certificate which was allowed to lapse by not renewing it. A retired licensee, registrant or certificateholder shall meet any requirements of the act or the regulations pertaining to continued education or continued competency to be eligible for renewal.
(c) Applications. An applicant for a volunteer license shall complete an application obtained from the Board. In addition to providing information requested by the Board, the applicant shall provide:
(1) An executed verification on forms provided by the Board certifying that the applicant intends to practice exclusively:
(i) Without personal remuneration for professional services.
(ii) In an approved clinic.
(2) A letter signed by the director or chief operating officer of an approved clinic that the applicant has been authorized to provide volunteer services in the named clinic by the governing body or responsible officer of the clinic.
(d) Validity of license. A volunteer license shall be valid for the biennial period for which it is issued, subject to biennial renewal. During each biennial renewal period, the volunteer license holder shall notify the Board of any change in clinic or volunteer status within 30 days of the date of the change, or at the time of renewal, whichever occurs first.
(e) Biennial renewal. A volunteer license shall be renewed biennially on forms provided by the Board.
(1) As a condition of biennial renewal, the applicant shall satisfy the same continuing education requirements as the holder of an active, unrestricted license.
(2) The applicant shall be exempt from payment of the biennial renewal fee in § 33.3 (relating to fees).
(f) Return to active practice. A volunteer license holder who desires to return to active practice shall notify the Board and apply for biennial registration on forms provided by the Board.
(g) Disciplinary provisions. A volunteer license holder shall be subject to the disciplinary provisions of the act and this chapter. Failure of the licensee to comply with the Volunteer Health Services Act or this section may also constitute grounds for disciplinary action.
(h) Permits to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(1) A dentist who applies for a volunteer license under subsection (b) who holds a current permit to administer anesthetic modalities may also apply for reissuance of an unrestricted or restricted permit of the type issued to the dentist as an active licensee under § 33.333 (relating to types of permits).
(2) A retired dentist who applies under subsection (b)(1) and (2) for a volunteer license who, within 2 years of the date of application, held an unrestricted permit or a restricted permit I, may apply for reissuance of the permit, but shall be required to comply with § 33.336a (relating to requirements for unrestricted permit and restricted permit I) by completing:
(i) An attestation in accordance with § 33.336a(b).
(ii) ACLS/PALS certification in accordance with § 33.336a(c).
(iii) Continuing anesthesia education in accordance with § 33.336a(d).
(3) A retired dentist who applies under subsection (b)(1) and (2) for a volunteer license who, within 5 years of the date of application, held a restricted permit II may apply for reissuance of the permit, but shall be required to comply with § 33.337(b) (relating to requirements for restricted permit II) by providing:
(i) A statement containing the make, model and serial number of nitrous oxide/oxygen analgesia equipment.
(ii) A certification that the equipment is properly calibrated, maintained, contains a fail-safe system and is in working order.
(iii) An attestation that the applicant has written procedures for handling emergencies.
(4) A dentist who applies for a volunteer license who does not qualify for a permit under paragraphs (1)--(3) and who wishes to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia under § 33.332(a) (relating to requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia) shall satisfy the educational requirements of § 33.335(a)(1), § 33.336 or § 33.337(a) (relating to requirements for unrestricted permit; requirements for restricted permit I; and requirements for restricted permit II), as applicable.
(5) Volunteer license holders will not be subject to any fee for the issuance, reissuance or renewal of a permit under this subsection.
(i) Supervision. Volunteer dental hygienists shall meet the supervision requirements of § 33.205(c)(1) (relating to practice as a dental hygienist). Volunteer expanded function dental assistants shall meet the supervision requirements of section 2 of the act (63 P. S. § 121).
Subchapter C. MINIMUM STANDARDS OF CONDUCT AND PRACTICE 33.209. Preparing, maintaining and retaining patient records.
(a) A dentist shall maintain a dental record for each patient which accurately, legibly and completely reflects the evaluation and treatment of the patient. A patient dental record shall be prepared and maintained regardless of whether treatment is actually rendered or whether a fee is charged. The record shall include, at a minimum, the following:
(1) The name and address of the patient and, if the patient is a minor, the name of the patient's parents or legal guardian.
(2) The date of each patient visit.
(3) A description of the patient's complaint, symptoms and diagnosis.
(4) A description of the treatment or service rendered at each visit and the identity of the person rendering it.
(5) Information as required in § 33.208 (relating to prescribing, administering and dispensing medications) and this section with regard to controlled substances or other medications prescribed, administered or dispensed.
(6) The date and type of radiographs taken and orthodontic models made, as well as the radiographs and models themselves. Notwithstanding this requirement, the dentist may release orthodontic models to the patient. This transaction shall be memorialized on a form which is signed by the patient. The signed form shall become part of the patient's record.
(7) Information with regard to the administration of local anesthesia, nitrous oxide/oxygen analgesia, conscious sedation, deep sedation or general anesthesia. This shall include results of the preanesthesia physical evaluation, medical history and anesthesia procedures utilized.
(8) The date of each entry into the record and the identity of the person providing the service if not the dentist of record-for example, dental hygienist, expanded function dental assistant, dental assistant, and the like.
(b) A patient dental record shall be retained by a dentist for a minimum of 5 years from the date of the last dental entry.
(c) Within 30 days of receipt of a written request from a patient or a patient's parents or legal guardian if the patient is a minor, an exact copy of the patient's written dental record, along with copies of radiographs and orthodontic models, if requested, shall be furnished to the patient or to the patient's new dentist. This service shall be provided either gratuitously or for a fee reflecting the cost of reproduction.
(d) The obligation to transfer records under subsection (c) exists irrespective of a patient's unpaid balance for dental services or for the cost of reproducing the record.
(e) Dentists shall provide for the disposition of patient records in the event of the dentist's withdrawal from practice, incapacity or death in a manner that will ensure their availability under subsection (c).
(f) The components of a patient dental record that are prepared by a dentist or an agent and retained by a health care facility regulated by the Department of Health or the Department of Public Welfare shall be considered a part of the patient dental record required to be maintained by a dentist, but shall otherwise be exempt from subsections (a)--(e). The components of a patient dental record shall contain information required by applicable Department of Health and Department of Public Welfare regulations--see, for example, 28 Pa. Code § 141.26 (relating to patient dental records)--and health care facility bylaws.
(g) This section does not restrict or limit the applicability of recordkeeping requirements in §§ 33.207 and 33.208 (relating to prescribing, administering and dispensing controlled substances; and prescribing, administering and dispensing medications).
(h) A dentist's failure to comply with this section will be considered unprofessional conduct and will subject the noncomplying dentist to disciplinary action as authorized in section 4.1(a)(8) of the act (63 P. S. § 123.1(a)(8)).
Subchapter E. ADMINISTRATION OF GENERAL ANESTHESIA, DEEP SEDATION, CONSCIOUS SEDATION AND NITROUS OXIDE/OXYGEN ANALGESIA § 33.331. Definitions.
The following words and phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:
AAOMS--American Association of Oral and Maxillofacial Surgeons.
AAOMS Guidelines--AAOMS Parameters and Pathways 2000 Clinical Practice Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities (AAOMS Par Path 2000), 4/15/99.
AAOMS Manual--AAOMS Office Anesthesia Manual, 6th Edition, 2000.
AAPD--American Academy of Pediatric Dentistry.
AAPD Guidelines--AAPD Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients (May, 1998).
ACLS--Advanced Cardiac Life Support.
ADA--American Dental Association.
ADA Guidelines--ADA Guidelines for the Use of Conscious Sedation, Deep Sedation and General Anesthesia for Dentists (October, 2000).
Adult patient--A patient 18 years of age or older.
Authorized agent--An organization or individual that the Board has officially authorized to act as the Board's agent in carrying out the mandates of the Board, the act or this chapter.
BLS--Basic Life Support
Board--The State Board of Dentistry.
CRNA--A registered nurse certified as a Registered Nurse Anesthetist by the Council on Certification or Recertification of Nurse Anesthetists of the American Association of Nurse Anesthetists authorized to administer anesthesia under § 21.17 (relating to the administration of anesthesia by a registered nurse.)
Clinical evaluation--A determination of the dentist's current technical competency to safely administer general anesthesia, deep sedation or conscious sedation and to effectively respond to anesthesia related emergencies, in accordance with the AAOMS Manual for OMSs or the ADA Guidelines (for adult patients) and the AAPD Guidelines (for pediatric patients) for general dentists.
Communications equipment--Equipment capable of being used to elicit a response in an emergency by voice, video or electronic data transmission, such as a telephone, video link, intercom, two-way radio or other similar device.
Conscious sedation--A minimally depressed level of consciousness that is produced by a pharmacologic method, a nonpharmacologic method, or a combination of both, in which the patient retains the ability to maintain an airway independently and continuously and to respond appropriately to physical stimulation or verbal command.
Deep sedation--A controlled, pharmacologically induced state of depressed consciousness from which the patient is not easily aroused and which may be accompanied by a partial loss of protective reflexes, including the ability to maintain a patent airway independently or respond purposefully to physical stimulation or verbal command, or both.
General anesthesia--A controlled state of unconsciousness that is produced by a pharmacologic method, a nonpharmacologic method, or a combination of both, and that is accompanied by a complete or partial loss of protective reflexes that include the patient's inability to maintain an airway independently and to respond purposefully to physical stimulation or verbal command.
General dentist--A dentist who is not an oral and maxillofacial surgeon.
Nitrous oxide/oxygen analgesia--The diminution or elimination of pain in the conscious patient through the use of nitrous oxide/oxygen.
OMS--Oral and Maxillofacial Surgeon who is a current member of the PSOMS or AAOMS.
Office inspection--A determination as to whether the offices where the dentist administers anesthesia is properly equipped as prescribed in § 33.340(a)(2), § 33.340a(a)(2) or § 33.340b(a)(2) (relating to duties of dentists who are unrestricted permitholders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders), as appropriate to the type of permit, and in accordance with the AAOMS Manual for OMSs, or the ADA Guidelines (for adult patients) and the AAPD Guidelines (for pediatric patients) for general dentists.
PALS--Pediatric Advanced Life Support.
PSOMS--Pennsylvania Society of Oral and Maxillofacial Surgeons.
Patient physical evaluation--An assessment of the patient's physical and mental condition relevant to the surgery to be performed and anesthesia or anesthetic to be utilized.
Pediatric patient--A patient under 18 years of age.
Peer evaluation organization--An entity approved by the Board for administering a program whereby licensed dentists conduct office inspections and clinical evaluations for dentists seeking initial or renewal unrestricted or restricted I permits in accordance with § 33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections).
Peer evaluator--A licensed dentist with a current unrestricted permit or restricted permit I who conducts an office inspection or clinical evaluation under the auspices of an approved peer evaluation organization.
Physician--A Pennsylvania licensed medical or osteopathic physician who is currently certified by the American Board of Anesthesiology or the American Osteopathic Board of Anesthesiology, or is credentialed to administer anesthesia in a hospital or ambulatory surgical facility licensed by the Department of Health.
§ 33.332. Requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(a) Permit required for administration of anesthetic modality in dental office. A dentist shall possess a current permit issued by the Board under this subchapter before administering, or supervising the administration of, general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in a dental office.
(b) Permit not required for administration of anesthetic modality in other facilities. A dentist is not required to possess a permit under this subchapter before administering, or supervising the administration of, general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in a State- or Federally-regulated facility other than a dental office.
(c) Failure to comply. A dentist's failure to comply with subsection (a) will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
§ 33.333. Types of permits.
The Board will issue the following permits to licensees qualified under this subchapter:
(1) Unrestricted permit. A permit which authorizes the holder to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(2) Restricted permit I. A permit which authorizes the holder to administer conscious sedation or nitrous oxide/oxygen analgesia.
(3) Restricted permit II. A permit which authorizes the holder to administer nitrous oxide/oxygen analgesia.
(4) Temporary permit. A permit limited to 1 year which authorizes the applicant for an unrestricted, restricted I or restricted II permit to administer the appropriate type of anesthesia relevant to the applicant's qualifications.
§ 33.334. Application for permit.
(a) A dentist who desires to obtain a permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, or a temporary permit, shall submit an application on a form provided by the Board, pay the permit fee prescribed in § 33.339 (relating to fees for issuance of permits) and meet the requirements for the permit applied for as prescribed in this subchapter.
(b) Application forms may be obtained from the State Board of Dentistry, Post Office Box 2649, Harrisburg, Pennsylvania 17105-2649.
§ 33.335. Requirements for unrestricted permit.
(a) To secure an unrestricted permit, a dentist shall have done one of the following:
(1) Successfully completed at least 2 years in a postgraduate program for advanced training in anesthesiology and related academic subjects that conforms to Part II of the American Dental Association's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.
(2) Possess current certification as a Diplomate of the American Board of Oral and Maxillofacial Surgeons, a Fellow of the American Association of Oral and Maxillofacial Surgery or a Fellow of the American Dental Society of Anesthesiology, or be eligible for examination by the American Board of Oral and Maxillofacial Surgery.
§ 33.336. Requirements for restricted permit I.
To secure a restricted permit I, a dentist shall have successfully completed a course on conscious sedation comprising at least 60 hours of undergraduate or postgraduate didactic instruction and clinical experience in a program that conforms to Part I (for an undergraduate program) or Part III (for a postgraduate program) of the ADA's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.
§ 33.336a. Requirements for unrestricted permit and restricted permit I.
(a) Office inspections and clinical evaluations.
(1) Initial permits. Initial unrestricted and restricted I permit applicants shall satisfactorily complete an office inspection and clinical evaluation conducted by an approved peer evaluation organization under § 33.336b (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections).
(2) First renewal permit beginning April 1, 2005. Beginning April 1, 2005, renewal unrestricted and restricted I permit applicants shall satisfactorily complete an office inspection and clinical evaluation as a condition for permit renewal. Completion of an office inspection and clinical evaluation may be waived if the applicant can demonstrate satisfactory completion of an office inspection and clinical evaluation, administered by an organization approved by the Board, within 6 years preceding April 1, 2005.
(3) Subsequent renewal permit. Following the applicant's initial permit renewal after April 1, 2005, unrestricted and restricted permit I renewal applicants shall satisfactorily complete an office inspection and clinical evaluation once every 6 years.
(4) Report of office inspection and clinical evaluation. An application for an initial or renewal permit shall contain documentation from the peer review organization that conducted the office inspection and clinical evaluation that evidences the applicant's satisfactory completion of an office inspection and clinical evaluation and a written report of the results of the office inspection and clinical evaluation.
(b) Standards for anesthesia administration.
(1) An OMS applicant for an unrestricted or restricted I permit shall attest that the administration of anesthesia to adult and pediatric patients will be conducted in conformance with the standards outlined in the AAOMS Guidelines and the AAOMS Manual.
(2) A general dentist applicant for an unrestricted or restricted I permit shall attest that the administration of anesthesia to adult patients will be conducted in conformance with the standards outlined in the ADA Guidelines and that the administration of anesthesia to pediatric patients will be conducted in conformance with the standards outlined in the AAPD Guidelines.
(c) ACLS/PALS certification.
(1) Adult patients. An applicant for an unrestricted or restricted I permit shall have successfully completed and maintained current certification in ACLS prior to the administration of anesthesia to an adult patient.
(2) Pediatric patients. An applicant for an unrestricted or restricted I permit shall have successfully completed and maintained current certification in PALS prior to the administration of anesthesia to a pediatric patient.
(d) Continuing anesthesia education.
(1) Beginning April 1, 2005, and for all subsequent renewal periods, the following hours of continuing education are required as a condition of permit renewal:
(i) Unrestricted permit. An applicant for an unrestricted permit shall have completed 15 hours of Board approved courses related to general anesthesia and deep sedation.
(ii) Restricted permit I. An applicant for a restricted permit I shall have completed 15 hours of Board approved courses related to conscious sedation.
(2) Continuing anesthesia education will be credited toward the permitholder's continuing education requirement under § 33.401(a)(1) (relating to credit-hour requirements).
§ 33.336b. Approved peer evaluation organizations for administering clinical evaluations and office inspections.
(a) The following organizations are deemed qualified to conduct clinical evaluations and office inspections and do not require prior approval from the Board:
(1) The American Association of Oral and Maxillofacial Surgeons (AAOMS).
(2) The Pennsylvania Society of Oral and Maxillofacial Surgeons (PSOMS).
(b) An organization of oral and maxillofacial surgeons or of unrestricted permit and restricted permit I holders that does not qualify as an organization to conduct clinical evaluations and office inspections under subsection (a) may apply to the Board for approval to serve as an organization to conduct clinical evaluations and office inspections. In determining whether to grant approval, the Board will consider the following factors:
(1) Whether the organization agrees to utilize peer evaluators meeting the following criteria:
(i) A minimum 5 years experience administering general anesthesia and deep sedation (for unrestricted permitholders) or conscious sedation (for restricted permit I holders) within the last 7 years.
(ii) A current unrestricted permit or restricted permit I.
(iii) Completion of a minimum 7-hour course in conducting office inspections and clinical evaluations.
(2) Whether the organization has sufficient peer evaluators that meet the criteria listed in § 33.336d (relating to qualifications of peer evaluation conducting office inspecting and clinical evaluations) to conduct office inspections and clinical evaluations.
(3) Whether the organization has the technical competence to administer office inspections and clinical evaluations to applicants for initial and renewal permits.
(4) Whether the organization's fee for office inspections and clinical evaluations is based upon reasonable costs.
(5) Whether the organization has standards for satisfactory completion of an office inspection and clinical evaluation.
(6) Whether the organization has an internal appeal procedure to contest the office inspection or clinical evaluation.
(7) Whether the organization has a peer review oversight committee whose members meet the following criteria:
(i) A minimum 5 years experience administering general anesthesia and deep sedation.
(ii) A current unrestricted permit.
(8) Whether the organization has procedures to facilitate fair, unbiased and equitable office inspections and clinical evaluations.
(9) Whether the organization agrees to make records of all office inspections and clinical evaluations available to the Board upon request and agrees to maintain these records for at least 5 years.
(10) Whether the organization agrees to conduct a subsequent office inspection or clinical evaluation within a reasonable time if the results of the initial office inspection or clinical evaluation are unsatisfactory.
(11) Whether the organization agrees to conduct office inspections and clinical evaluations in conformance with the standards outlined in the AAOMS Manual and AAOMS Guidelines (for OMSs) and the ADA Guidelines or AAPD Guidelines (for general dentists), and in accordance with §§ 33.340 and 33.340a (relating to duties of dentists who are unrestricted permitholders; and duties of dentists who are restricted permit I holders).
(12) Whether the organization agrees to utilize peer evaluator teams consisting of at least two permitholders as follows:
(i) For office inspections and clinical evaluations of unrestricted permitholders and applicants, a team of at least two unrestricted permitholders.
(ii) For office inspections and clinical evaluations of restricted permit I holders and applicants, a team consisting of at least two unrestricted permitholders, or a team consisting of at least one unrestricted permitholder and one restricted permit I holder.
(c) An approved peer evaluation organization may not require a permit applicant to become a member of the organization as a precondition for the organization to conduct a clinical evaluation and office inspection for the applicant.
§ 33.336c. Standards for office inspections and clinical evaluations.
Office inspections and clinical evaluations shall be conducted in accordance with the AAOMS Manual and AAOMS Guidelines for OMSs and the ADA Guidelines and AAPD Guidelines for general dentists.
§ 33.336d. Qualifications of peer evaluators conducting office inspections and clinical evaluations.
(a) A peer evaluator conducting office inspections and clinical evaluations of unrestricted permitholders and applicants shall be a licensed dentist holding a current unrestricted permit.
(b) A peer evaluator conducting office inspections and clinical evaluations of restricted permit I holders and applicants shall be a licensed dentist holding either a current unrestricted permit or a current restricted permit I, provided that a peer evaluator holding a current restricted permit I may only conduct office inspections and clinical evaluations when part of a team consisting of at least one unrestricted permitholder.
(c) A peer evaluator shall be independent from, and have no conflict of interest with, the dentist or dental practice being reviewed.
(d) The administering approved peer evaluation organization shall ensure that its peer evaluators are qualified under this section.
§ 33.336e. Confidentiality of peer evaluation reports.
(a) Office inspection and clinical evaluation reports and related information shall remain confidential except as provided in § 33.336a(a)(4) (relating to requirements for unrestricted permit and restricted permit I) and the act of June 21, 1957 (P. L. 390, No. 212) (65 P. S. §§ 66.1--66.4), known as the Right-to-Know Law.
(b) An administering approved peer evaluation organization shall submit to the Board a written report of the results of the office inspection and clinical evaluation within 30 days from the date the office inspection and clinical evaluation was that documents whether the applicant has successfully completed the office inspection and clinical evaluation.
(c) If a clinical evaluation or office inspection reveals that the noncompliance of a dentist or dental office presents an immediate and clear danger to the public health and safety, the administering approved peer evaluation organization shall immediately notify the commissioner of the Bureau.
§ 33.337. Requirements for restricted permit II.
(a) To secure a restricted permit II, a dentist shall have successfully completed a course in nitrous oxide/oxygen analgesia comprising at least 14 hours of undergraduate or postgraduate didactic instruction and clinical experience in a program that conforms to Part I (for an undergraduate program) or Part III (for a postgraduate program) of the ADA's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.
(b) Initial restricted II permit applicants shall provide the following:
(1) The make, model and serial number of any nitrous oxide/oxygen analgesia equipment utilized by the applicant.
(2) Certification that the equipment is properly calibrated and maintained, contains a fail-safe system and is in working order.
(3) An attestation that the applicant has written office procedures for administering nitrous oxide/oxygen analgesia and handling emergencies related to the administration of nitrous oxide/oxygen analgesia.
(c) Subsequent renewal permits. Following the applicant's initial permit renewal after April 1, 2004, for each subsequent renewal period, an applicant shall provide an attestation to the Board, in accordance with § 33.338(b)(4) (relating to expiration and renewal of permits), that the nitrous oxide/oxygen analgesia equipment that the applicant uses is properly calibrated and maintained and contains a fail-safe system.
§ 33.337a. Requirements for temporary permit.
(a) To secure a temporary unrestricted permit, restricted permit I or restricted permit II, an applicant shall include with the application proof that the applicant possesses the qualifications required for the type of permit requested.
(b) Temporary permits expire 1 year following the effective date and may not be renewed.
§ 33.338. Expiration and renewal of permits.
(a) A permit issued by the Board under this subchapter will expire at the same time as the permitholder's dental license but may be renewed biennially at the same time the dental license is renewed.
(b) A dentist who desires to renew a permit shall submit the following:
(1) A renewal application on a form provided by the Board.
(2) The permit renewal fee prescribed in § 33.339 (relating to fees for issuance of permits).
(3) Proof of current certification in ACLS (adult patients) or PALS (pediatric patients), or both (for unrestricted permits and restricted I permits).
(4) An attestation, on the renewal application, that any equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia has been installed, properly calibrated and maintained according to the equipment manufacturer's guidelines and contains a fail-safe system (for all permits).
(5) Proof of compliance with the continuing anesthesia education requirement under § 33.336a(d) (relating to requirements for unrestricted permit and restricted I permit).
(6) Proof of compliance with the office inspection and clinical evaluation requirements under § 33.336a(a).
§ 33.339. Fees for issuance of permits.
The following fees are charged for the issuance of permits under this subchapter:
(1) Unrestricted permit. (i) Initial $100 (ii) Renewal $200 (iii) Temporary $100 (2) Restricted permit I. (i) Initial $100 (ii) Renewal $200 (ii) Temporary $100 (3) Restricted permit II. (i) Initial $15 (ii) Renewal $50 (iii) Temporary $15 § 33.340. Duties of dentists who are unrestricted permitholders.
(a) A dentist who possesses an unrestricted permit issued under this subchapter shall ensure that:
(1) Prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, the permitholder takes or updates a patient medical history and gives the patient a physical evaluation sufficient to determine the patient's suitability to receive general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(2) The dental office in which the permitholder administers general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia on an outpatient basis contains the following:
(i) An operating room.
(ii) An operating table or chair.
(iii) A lighting system.
(iv) Suction equipment commensurate with the patient's age, size and condition.
(v) Oxygen and supplemental gas delivery systems, including primary and back-up sources and a fail-safe control mechanism.
(vi) A sterilization area.
(vii) A recovery area.
(viii) A gas storage area and scavenger system.
(ix) Emergency airway equipment and medications, including intravenous emergency equipment.
(x) Communications equipment.
(xi) Patient transport equipment.
(xii) Monitoring equipment, procedures and documentation to conform to the age, size and condition of the patient and the AAOMS Manual and AAOMS Guidelines for adult and pediatric patients (OMS); the ADA Guidelines for adult patients (general dentists); and the AAPD Guidelines for pediatric patients (general dentists).
(xiii) Capnograph for intubated patients and pulse oximeter.
(xiv) ECG.
(xv) Blood pressure monitoring device.
(xvi) Defibrillator.
(xvii) Results of patient medical history and patient physical evaluation, and identification of anesthesia procedures to be utilized, prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(xviii) Signed, written, informed patient consent, prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, which includes a description of the procedure, its risks and possible alternative treatments. Consent for a minor patient shall be obtained from the minor's parent or guardian.
(xix) Stethoscope.
(3) Auxiliary personnel who assist the permitholder in the administration of general anesthesia, deep sedation or conscious sedation:
(i) Are trained to perform the duties that the permitholder delegates to them, if the duties do not require the professional judgment and skill of the permitholder and do not involve the actual administration of general anesthesia, deep sedation or conscious sedation.
(ii) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(iii) Do not render assistance in areas that are beyond the scope of the permitholder's authority.
(iv) Are currently certified in BLS.
(4) CRNAs who are delegated the duties of administering general anesthesia, deep sedation or conscious sedation:
(i) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(ii) Do not perform duties that are beyond the scope of the permitholder's authority.
(iii) Are currently certified in ACLS.
(5) The dentist possesses a current certification in ACLS for adult patients and PALS for pediatric patients.
(6) The Board receives a complete report of a death or incident requiring medical care and resulting in physical or mental injury that directly resulted from the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by the permitholder or by a CRNA working under the supervision of the permitholder. The permitholder shall submit the report within 30 days of the death or incident.
(7) The Board receives prior notice of the first time that a dental office of the permitholder will be used for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(8) General anesthesia or deep sedation administered to pediatric patients by or under the delegation of a general dentist is administered by a person dedicated solely to the administration and monitoring of anesthesia, and the dental procedures are performed by a dental licensee who is not involved in the administration of the general anesthesia.
(9) Monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is installed, maintained and calibrated according to the equipment manufacturer's guidelines; is in proper working condition prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia; and monitoring equipment is being used during the administration of general anesthesia.
(10) If the permitholder travels to the offices of non-permitholders for the purpose of administering general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, the permitholder shall satisfactorily complete a clinical evaluation and the equipment transported to the nonpermitholder dentist's office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by a permitholder shall satisfactorily complete an inspection conducted by an approved peer evaluation organization under § 33.336b(a) (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections) in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines (OMS). As part of that clinical evaluation and inspection, the permitholder shall certify that each office location in which general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia is administered by the permitholder has the equipment required by paragraph (2) and that the staff is properly trained to handle anesthesia-related emergencies.
(11) General anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMSs) or to adult patients in accordance with the ADA Guidelines (general dentists) or to pediatric patients in accordance with the AAPD Guidelines (general dentists). Conflicts between the AAOMS Guidelines, the AAOMS Manual, the ADA Guidelines, or the AAPD Guidelines and this subchapter shall be resolved in favor of this subchapter.
(12) Patient records are prepared, maintained and retained in accordance with § 33.209 (relating to preparing, maintaining and retaining patient records).
(b) A dentist's failure to comply with this section will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
§ 33.340a. Duties of dentists who are restricted permit I holders.
(a) A dentist who possesses a restricted permit I issued under this subchapter shall ensure that:
(1) Prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia, the permitholder takes or updates a patient medical history and gives the patient a physical evaluation sufficient to determine the patient's suitability to receive conscious sedation or nitrous oxide/oxygen analgesia.
(2) The dental office in which the permitholder administers conscious sedation or nitrous oxide/oxygen analgesia on an outpatient basis contains the following:
(i) An operating room.
(ii) An operating table or chair.
(iii) A lighting system.
(iv) Suction equipment commensurate with the patient's age, size and condition.
(v) Oxygen and supplemental gas delivery systems, including primary and back-up sources and a fail-safe control mechanism.
(vi) A sterilization area.
(vii) A recovery area.
(viii) A gas storage area and scavenger system.
(ix) Emergency airway equipment and medications, including intravenous emergency equipment.
(x) Communications equipment.
(xi) Patient transport equipment.
(xii) Monitoring equipment, procedures and documentation to conform to the age, size and condition of the patient and the AAOMS Manual and AAOMS Guidelines for adult and pediatric patients (OMS); the ADA Guidelines for adult patients (general dentists); and the AAPD Guidelines for pediatric patients (general dentists.)
(xiii) Pulse oximeter.
(xiv) ECG.
(xv) Blood pressure monitoring device.
(xvi) Defibrillator.
(xvii) Results of patient medical history and patient physical evaluation, and identification of anesthesia procedures to be utilized, prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia.
(xviii) Signed, written, informed patient consent, prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia, which includes a description of the procedure, its risks and possible alternative treatments. Consent for a minor patient shall be obtained from the minor's parent or guardian.
(xix) Stethoscope.
(3) Auxiliary personnel who assist the permitholder in the administration of conscious sedation:
(i) Are trained to perform the duties that the permitholder delegates to them, if the duties do not require the professional judgment and skill of the permitholder and do not involve the actual administration of conscious sedation.
(ii) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(iii) Do not render assistance in areas that are beyond the scope of the permitholder's authority.
(iv) Are currently certified in BLS.
(4) CRNA who are delegated the duties of administering conscious sedation:
(i) Perform their duties under the direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.
(ii) Do not perform duties that are beyond the scope of the permitholder's authority.
(iii) Are currently certified in ACLS.
(5) The dentist possesses a current certification in ACLS for adult patients and PALS for pediatric patients.
(6) The Board receives a complete report of a death or incident requiring medical care and resulting in physical or mental injury that directly resulted from the administration of conscious sedation or nitrous oxide/oxygen analgesia by the permitholder or by a CRNA working under the supervision of the permitholder. The permitholder shall submit the report within 30 days of the death or incident.
(7) The Board receives prior notice of the first time that a dental office of the permitholder will be used for the administration of conscious sedation or nitrous oxide/oxygen analgesia.
(8) Monitoring equipment and equipment used to administer conscious sedation and nitrous oxide/oxygen analgesia is installed, maintained and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and is in proper working condition prior to the administration of conscious sedation or nitrous oxide/oxygen analgesia.
(9) If the permitholder travels to the offices of non-permitholders for the purpose of administering conscious sedation or nitrous oxide/oxygen analgesia, the permitholder shall satisfactorily complete a clinical evaluation and the equipment transported to a non-permitholder dentist's office for the administration of conscious sedation or nitrous/oxide oxygen analgesia by a permitholder must satisfactorily complete an inspection conducted by an approved peer evaluation organization under § 33.336b(a) (relating to approved peer evaluation organizations for administering clinical evaluations and office inspections) in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines, the ADA Guidelines or the AAPD Guidelines, as applicable. As part of that clinical evaluation and inspection, the permitholder shall certify that each office location in which conscious sedation or nitrous oxide/oxygen analgesia is administered has the equipment required by paragraph (2) and that the staff is properly trained to handle anesthesia-related emergencies.
(10) Conscious sedation and nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMSs) or to adult patients in accordance with the ADA Guidelines (general dentists) or to pediatric patients in accordance with the AAPD Guidelines (general dentists). Conflicts between the AAOMS Guidelines, the AAOMS Manual, the ADA Guidelines, or the AAPD Guidelines and this subchapter shall be resolved in favor of this subchapter.
(11) Patient records are prepared, maintained and retained in accordance with § 33.209 (relating to preparing, maintaining and retaining patient records).
(b) A dentist's failure to comply with this section will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
§ 33.340b. Duties of dentists who are restricted permit II holders.
(a) A dentist who possesses a restricted permit II issued under this subchapter shall ensure that:
(1) Prior to the administration of nitrous oxide/oxygen analgesia, the permitholder takes or updates a patient medical history and gives the patient a physical evaluation sufficient to determine the patient's suitability to receive nitrous oxide/oxygen analgesia.
(2) The dental office in which the permitholder administers nitrous oxide/oxygen analgesia on an outpatient basis contains the following:
(i) An operating room.
(ii) An operating table or chair.
(iii) A lighting system.
(iv) Dental office suction equipment.
(v) Oxygen and supplemental gas delivery systems, including primary and back-up sources and a fail-safe control mechanism.
(vi) A sterilization area.
(vii) A gas storage area and scavenger system.
(viii) Communications equipment.
(ix) Monitoring equipment, procedures and documentation to conform to the age, size and condition of the patient and the AAOMS Manual and AAOMS Guidelines for adult and pediatric patients (OMS), the ADA Guidelines for adult patients (general dentists) and the AAPD Guidelines for pediatric patients (general dentists).
(x) Results of patient medical history, patient physical evaluation and identification of the nitrous oxide/oxygen analgesia procedure to be utilized, prior to the administration of nitrous oxide/oxygen analgesia.
(xi) Signed, written, informed patient consent, prior to the administration of nitrous oxide/oxygen analgesia, which includes a description of the procedure, its risks and possible alternative treatments. Consent for a minor patient shall be obtained from the minor's parent or guardian.
(xii) Stethoscope.
(3) Nitrous oxide/oxygen analgesia is administered to adult and pediatric patients in accordance with the AAOMS Guidelines and AAOMS Manual (OMS) or to adult patients in accordance with the ADA Guidelines (general dentists) or to pediatric patients in accordance with the AAPD Guidelines (general dentists). Conflicts between the AAOMS Guidelines, the AAOMS Manual, the ADA Guidelines or the AAPD Guidelines and this subchapter shall be resolved in favor of this subchapter.
(4) Monitoring equipment and equipment used to administer nitrous oxide/oxygen analgesia is installed, maintained and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and is in proper working condition prior to the administration of nitrous oxide/oxygen analgesia.
(5) Patient records are prepared, maintained and retained in accordance with § 33.209 (relating to preparing, maintaining and retaining patient records).
(b) A dentist's failure to comply with this section will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
§ 33.341. Duties of dentists who are not permitholders.
(a) A dentist who does not possess a permit issued under this subchapter may not allow general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia to be administered on an outpatient basis in his dental office unless the following conditions are met:
(1) The Board receives prior notice of the first time that the dental office will be used for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(2) The dental office meets the appropriate equipment and facility requirements prescribed in § 33.340(a)(2), § 33.340a(a)(2) or § 33.340b(a)(2) (relating to duties of dentists who are unrestricted permitholders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders) and the Board receives a written certification from the dentist to that effect.
(3) The general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia, are administered by one of the following:
(i) The holder of a permit under this subchapter or CRNA delegatee.
(ii) A physician as defined in § 33.331 (relating to definitions).
(4) Either the dentist who performs the dental procedure or the CRNA, physician or permitholder who administers the general anesthesia, deep sedation or conscious sedation possesses a current certification in ACLS.
(5) The nonpermitholder dentist receives a written certification from the permitholder that all monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is present in the non-permitholder's office, is properly installed, maintained and calibrated according to the equipment manufacturer's guidelines, contains a fail-safe system and is in proper working condition prior to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, and that monitoring equipment is being used during the administration of general anesthesia.
(6) The nonpermitholder receives a written certification from the permitholder that the permitholder has satisfactorily completed a clinical evaluation and the equipment transported to the nonpermitholder dentist's office for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by a permitholder has satisfactorily completed an inspection conducted by an approved peer evaluation organization under § 33.336b(a) (relating to approved peer evaluation organizations for administering clinical evaluations and office inspection), in accordance with the requirements of the AAOMS Manual and AAOMS Guidelines (OMS), ADA Guidelines or AAPD Guidelines, as applicable.
(b) A dentist shall submit to the Board a complete written report on a death or an incident requiring medical care and resulting in physical or mental injury that directly resulted from the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in his dental office. The report shall be submitted within 30 days of the death or incident.
(c) A dentist's failure to comply with this section will be considered unprofessional conduct and will subject the dentist to disciplinary action under section 4.1 of the act (63 P. S. § 123.1).
(d) Beginning April 1, 2005, and for all subsequent renewal periods, non-permitholder licensees who maintain offices in which general anesthesia, deep sedation or conscious sedation is administered, shall have completed 5 hours of Board approved courses related to anesthesia. These 5 hours shall be credited toward the nonpermitholder licensee's continuing education requirement under § 33.401(a)(1) (relating to credit hour requirements).
§ 33.342. Inspection of dental offices.
(a) Inspections. The Board, through its authorized agents, may conduct inspections of a dental office with or without prior notice, for the purpose of determining whether the office is in compliance with the equipment and facility requirements prescribed in § 33.340(a)(2), § 33.340a(a)(2) or § 33.340b(a)(2), (relating to duties of dentists who are unrestricted permitholders; duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders) or as follows:
(1) Upon a death or injury related to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in the office.
(2) Upon a complaint that the office or the dentist who operates the office is not in compliance with this subchapter.
(3) Upon a reasonable belief that conditions exist in the office that pose a danger to the health or safety of the public.
(b) Notice of inspection. Prior to the start of an inspection of a dental office, the Board's authorized agents will advise the dentist whose office is being inspected that the inspection is being made under this section and is limited in scope by this section.
(c) Access during inspection. A dentist shall give the Board's authorized agents access to:
(1) Areas of the dental office where general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia are administered.
(2) Equipment, supplies, records and documents relating to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
(3) Interviews with auxiliary personnel.
(d) Guideline for inspection. An inspection will be conducted under provisions pertaining to office facilitiesand equipment in § 33.340(a)(2), § 33.340a(a)(2), § 33.340b(a)(2) or § 33.341(2) (relating to duties of dentists who are not permitholders).
(e) Inspection showing noncompliance.
If an inspection reveals that a dental office is not in compliance with the equipment and facility requirements prescribed in § 3.340(a)(2), § 33.340a.(a)(2), § 33.340b.(a)(2) or § 33.341(2), the Board will give the dentist whose office was inspected written notice of the deficiencies and of the deadline for correcting the deficiencies. A reinspection shall take place within 30 days, and, if noncompliance is still shown, formal administrative charges may be initiated.
[Pa.B. Doc. No. 05-939. Filed for public inspection May 13, 2005, 9:00 a.m.]
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