RULES AND REGULATIONS
Title 49--PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF DENTISTRY
[49 PA. CODE CH. 33]
Administration of General Anesthesia, Deep Sedation, Conscious Sedation and Nitrous Oxide/Oxygen Analgesia
[35 Pa.B. 2880] The State Board of Dentistry (Board) amends §§ 33.110 and 33.209 (relating to volunteer license; and preparing, maintaining and retaining patient records) and Subchapter E (relating to administration of general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia) to read as set forth in Annex A.
A. Effective Date
The final-form rulemaking will be effective upon publication in the Pennsylvania Bulletin.
B. Statutory Authority
The Board is authorized to adopt regulations concerning anesthesia under sections 3(o) and 11.2(a) of The Dental Law (act) (63 P. S. §§ 122(o) and 130c(a)).
C. Background and Purpose
The final-form rulemaking is in response to the act of November 25, 2002 (P. L. 1109, No. 135) (Act 135) and Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999), which held that the term ''appropriate monitoring equipment'' in § 33.340 (relating to duties of dentists who are unrestricted permitholders) is unconstitutionally vague. Shortly after the decision, the Board constituted an Anesthesia Committee (Committee). The Committee was tasked with reviewing state-of-the-art equipment, procedures and protocols for safe and effective delivery of anesthesia and analgesia in dental offices. Several drafts of the proposed rulemaking were developed. On March 23, 2001, the Board approved the final draft for promulgation as proposed rulemaking. Proposed rulemaking was published at 31 Pa.B. 6691 (December 8, 2001).
Following the comment period, the Board and its Committee reviewed the comments received. The Committee met on March 14, 2002, to consider the suggestions and prepare responses. Just prior to that meeting, the Committee learned that Dr. Robert S. Muscalus, Physician General, had several concerns regarding the proposed rulemaking. Accordingly, the Committee invited Dr. Muscalus to address these concerns at the Committee's March 14, 2002, meeting. The entire Board entertained Dr. Muscalus's suggestions at the March 15, 2002, Board meeting.
A final rulemaking package approved by the Board was under internal Department of State (Department) review on November 25, 2002, when Act 135 was signed by the Governor and became effective December 25, 2002. The passage of Act 135 required that the Board's anesthesia regulations be rewritten.
Changes required by Act 135 and implementation issues were reviewed by the Department and the Committee, in particular implementation of the clinical evaluations and office inspections. The Board's current regulations, adopted in 1988, require clinical evaluations and office inspections for unrestricted and restricted I permitholders. However, clinical evaluations and office inspections have never been implemented due to the inability to find individuals or organizations willing to conduct them due to liability concerns.
The following options were explored: 1. Commonwealth employee--This option provides the protection of sovereign immunity for governmental employees. However, because of the complexity of the subject matter and the need for persons trained in dentistry, surgery and anesthesia, the costs of training current Department inspectors or hiring oral and maxillofacial surgeons (OMS) or unrestricted permitholders are prohibitive. It is not feasible to train current Department inspectors, none of whom have medical, dental or anesthesia backgrounds. If current inspectors were to perform the clinical evaluations and office inspections, the evaluations and inspections would have to be considerably simplified, which the Board believes would not accomplish the goal of public protection.
The Department had, in the past, made efforts to hire qualified dentists. However, none of these efforts produced a single dentist willing to accept employment at Commonwealth salaries.
2. Independent contractor--Nongovernmental agents may act for the government only as independent contractors and cannot be indemnified by the Commonwealth. Potential contractors were not found.
3. Volunteer--Volunteers would also be subject to contracts defining the scope of their activities and limits of authority, and liability coverage or a statutory exemption from certain types of liability would be necessary. The Board had been involved, both prior to and following the passage of Act 135, in discussions with the Pennsylvania Society of Oral and Maxillofacial Surgeons (PSOMS) concerning the possibility of the PSOMS conducting the clinical evaluations and office inspections for nonmember permitholders. The PSOMS, the only known organization to date with the experience and expertise to conduct the clinical evaluations and office inspections, has conducted clinical evaluations and office inspections for its members since 1975. The clinical evaluations and office inspections are performed by volunteer PSOMS members, who are provided with liability insurance coverage by the PSOMS' insurance carrier.
4. Legislative amendment to the act to grant limited immunity to evaluators/inspectors--The PSOMS prepared a draft amendment, which was supported by the Department. In May 2004, House Bill 2651 (P.N. 3950) was introduced. This bill would provide limited immunity for persons conducting clinical evaluations and office inspections and extends certain deadlines for Act 135 compliance. However, this bill was not enacted during the 2004 session.
As a result, the Board's second proposed rulemaking package sets up an ''approved peer evaluation'' system for clinical evaluations and office inspections. Although the regulations leave it open for any organization to apply to be an approved peer evaluation organization, the PSOMS was the only entity that the Board was currently aware of that had the resources and ability to conduct these highly technical and fairly lengthy evaluations and inspections.
Proposed rulemaking incorporating all changes required by Act 135 was published at 34 Pa.B. 1949 (April 10, 2004).
Publication was followed by a 30-day public comment period during which the Board received comments from five organizations and two individuals. The Board received public comments from the PSOMS; the Pennsylvania Dental Association (PDA); the Pennsylvania Society of Anesthesiologists (PSA); the Pennsylvania Association of Nurse Anesthetists (PANA); Highmark Inc. and its dental subsidiary, United Concordia Companies, Inc. (UCCI); and two individual dentists. The Board also received comments from the House Professional Licensure Committee (HPLC) and the Independent Regulatory Review Commission (IRRC) under the Regulatory Review Act (71 P. S. §§ 745.1--745.12). The Board did not receive comments from the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC).
Following the comment period, the Board and its Committee reviewed all comments received. The Board met on June 4, 2004, to consider the suggestions and prepare responses. However, since all comments had not been received by that date, the Board instructed its Committee to review all comments and to determine initial responses for this final rulemaking package. The Committee met by means of a teleconference on July 26, 2004. After considering all of the public comments, this final-form rulemaking was drafted and presented to the Board at its October 22, 2004, meeting. The Board subsequently voted to adopt the final-form rulemaking at its December 3, 2004, meeting.
D. Comment and Regulatory Review of Proposed Rulemaking
Volunteer Regulations
The HPLC and IRRC commented that the Board's existing volunteer license regulations need to be amended to conform to the amendments to the anesthesia regulations and to cross-reference the requirements for continuing anesthesia education and office inspections and clinical evaluations. In response, the Board amended § 33.110 to cross-reference certain provisions in §§ 33.336a and 33.337 (relating to requirements for unrestricted permit and restricted permit I; and requirements for restricted permit II) regarding the qualifications of the volunteer licensee to administer anesthesia. However, because volunteer license holders are required to provide their services only in an approved clinic, as defined by section 3 of the Volunteer Health Services Act (35 P. S. § 449.43), the Board did not extend the office inspection/clinical evaluation requirement to those facilities. The Board notes that as of January 2005, the Board has only three active volunteer dentist licensees and that none of these licensees hold an anesthesia permit.
Compliance with Act 135
The HPLC noted that Act 135 requires that as of April 1, 2004, all initial applications for permits and initial applications for renewal of permits include an office inspection and clinical evaluation. The Board notes that section 1 of Act 135 which amends section 11.2(b)(1) of the act requires that, beginning April 1, 2004, only initial permits to administer general anesthesia, deep sedation or conscious sedation (unrestricted permit and restricted permit I) require a clinical evaluation and office inspection. The Board acknowledges that this deadline has passed. Section 11.2(b)(6) requires that, as of April 1, 2005, unrestricted and restricted I permitholders seeking renewal for the biennial period beginning April 1, 2005, must have a clinical evaluation and office inspection. The Board intended this regulation to be effective prior to April 1, 2005, and has provided actual notice to each current holder of an unrestricted permit or a restricted permit I of Act 135 requirements regarding office inspection and clinical evaluations. The Board notes that section 11.2(b)(6) of the act allows the Board to waive the clinical evaluation and office inspection requirement for unrestricted and restricted I permit renewals beginning April 1, 2005, if the permitholder can demonstrate to the Board's satisfaction that he has satisfactorily undergone a clinical evaluation, administered by an organization acceptable to the Board, within the 6 years immediately preceding April 1, 2005. As of January 1, 2005, there were 466 unrestricted permitholders and 477 restricted I permitholders. According to the PSOMS, most of the 466 unrestricted permitholders are members of the PSOMS and many have satisfactorily undergone both a clinical evaluation and office inspection within the previous 6 years. In addition, the PSOMS is now offering inspections and clinical evaluations to nonmembers. The Board anticipated that a majority of these permitholders will have complied with the requirement prior to April 1, 2005.
The HPLC also noted that the proposed rulemaking was delivered to the Committee on March 31, 2004, 1 day before the statutorily imposed deadline. The Board acknowledges that unresolved issues and uncertainty regarding implementation of this final-form rulemaking has taken a considerable amount of time and effort on behalf of the Board and the Department. The Board would refer the HPLC to the efforts undertaken by the Board as outlined in Section C of this preamble to implement the Act 135 requirements in a timely manner. The Board feels that it has worked consistently on this final-form rulemaking from inception of the first proposed rulemaking through this final-form rulemaking. Given the technical nature of the final-form rulemaking and the varying opinions of the various organizations and other interested parties, the Board sought to assure that the final-form rulemaking safeguards the public's health and safety, while not unduly restricting access to care for the citizens of this Commonwealth.
Noting that Act 135 permits the Board to contract with dental schools, organizations and individuals to perform clinical evaluations and office inspections, the HPLC questioned why the proposed rulemaking did not mention contracting with any of those entities. IRRC agreed that it does not appear that the Board has exercised the option to contract with other entities or individuals to carry out the mandates of Act 135, and requested an explanation as to why it has not pursued the contracting option, whether there were other organizations that should be recognized as qualified peer evaluation organizations and how the Board intends to address the liability issue. The HPLC also requested an explanation as to why the Board had not explored the possibilities listed in section 11.2(b)(1) of the act with respect to who may conduct the clinical evaluations and office inspections.
The Board has made numerous attempts to identify viable options for providing the office inspections and clinical evaluations as outlined in Section C of this preamble. Additionally, under the direction of the Commissioner of Professional and Occupational Affairs, the Board is also, in addition to publishing this final-form rulemaking, working simultaneously on a Request for Proposal (RFP) for independent contractors; again attempting to hire anesthesia trained dentists at Commonwealth salaries; supporting a statutory amendment to grant immunity to inspectors and an extension of time for Act 135 compliance; and issuing temporary permits as authorized by section 11.2(c) of the act to initial applicants until April 1, 2005.
Moreover, none of the three dental schools in this Commonwealth have indicated an interest in providing the clinical evaluations and office inspections. After more than 5 years of study, the only organization identified by the Board that is willing and able to conduct the required inspections and evaluations is the PSOMS. However, the Board continues to actively seek qualified providers and would welcome inquiries from other qualified organizations under § 33.336b(b) (relating to approved peer evaluation organizations for administering evaluations and office inspections).
With regard to the liability issue, the Board would still support the legislation that was proposed in the last legislative session that would limit inspectors' liability. However, given the fact that the PSOMS has been able to obtain the necessary liability coverage to extend their existing peer evaluation program to nonmembers, the Board believes that the liability issue previously raised should not be an impediment to other organizations who wish to become approved peer review organizations.
Notice to Licensees
The HPLC requested information as to whether the Board has provided any notice or information to licensees regarding the clinical evaluations and office inspections. Information has been provided to licensees in the Board's newsletter mailed to each licensee during the summer of 2004. In addition, a special notice was sent to all unrestricted and restricted I permitholders in August 2004 to notify them of the requirements that they obtain an office inspection and clinical evaluation prior to renewing their anesthesia permits in 2005.
Individuals as Peer Review Evaluators
IRRC questioned whether individual permitholders could apply to conduct peer evaluations. Section 11.2(b)(1) the act allows the Board to contract with dental schools, organizations or individuals to perform the clinical evaluations and office inspections. While authorized by the act to contract with individuals, the regulations have now been amended to require peer evaluator teams consisting of at least two individuals due to the highly technical and lengthy inspection and evaluation process. Therefore, the Board elected not to amend the regulations to include ''individuals'' as peer evaluators.
Peer Review Organizations--Restricted Permit I Holders
IRRC, the PDA and Dr. Walter Laverick, D.M.D. recommended that other dental organizations representing the specialties of pediatric dentistry, periodontology, and the like, be permitted to apply to become an organization to conduct office inspections and clinical evaluations of restricted permit I offices to ensure that dentists of the same specialties and permit types are available to conduct inspections and evaluations for permit level I holders. The PDA commented that restricting the pool of potential peer evaluators to only those who hold an unrestricted permit places an undue burden on those permitholders who make up approximately 1/2 of the affected permitholders. The Board has addressed this comment by amending the regulations to allow restricted permit I holders to conduct office inspections and clinical evaluations of restricted permit I holders and applicants, but only when part of a team that is comprised of at least one unrestricted permitholder.
Criteria for Review of Peer Review Organizations
IRRC requested an explanation as to how the criteria were developed for reviewing a peer review organization application. The Board developed some of the criteria by reviewing the criteria used by other professional board and commissions, which use similar evaluation systems, and other criteria were developed by the Board independently. IRRC also requested an explanation as to how the Board will determine an applicant's compliance with the criteria in paragraphs (3), (5) and (8) regarding technical competence to administer evaluations and inspections, standards for satisfactory completion of an office inspection and clinical evaluation and procedures to facilitate fair, unbiased and equitable office inspections and evaluations. IRRC suggested that the Board specify the documentation an applicant must produce to demonstrate compliance with these paragraphs. The Board has developed specific requirements for inspections and evaluations, which have currently been incorporated in the RFP. The Board expects to require the same types of documentation from applicants for peer review organizations under the regulations as they would of potential contractors under the RFP. These currently include a management summary, work plan, statement of experience and qualifications, statement of personnel assigned to the program, description of training provided to peer evaluators, description of facilities and equipment dedicated to the program and similar information. Sample inspection and evaluation forms, curricula vitae of peer evaluators, written protocols for performance of inspections and evaluations are all examples of documentation that may be provided. However, the Board has declined to list all of the documents that could possibly be utilized to comply with this section in the regulations. Organizations that wish to apply to become approved peer review organizations will be provided guidelines to assist them in preparing their applications when requested.
Continuing Education
The HPLC commented on the reduction of hours of continuing education for permitholders and requested the Board's rationale for this reduction. Act 135, not the Board, has reduced the number of hours of continuing education required as a condition of permit renewal by specifying a certain number of hours of continuing education in anesthesia (restricted--15 hours; restricted I--15 hours; nonpermitholders allowing anesthesia in offices--5 hours) and crediting the continuing anesthesia education toward the permitholder's 30 hours of continuing education required for licensure under section 3(j.2)(2) of the act. The Board had recommended that anesthesia permitholders be required to obtain the anesthesia continuing education hours in addition to the 30 hours of continuing education already required for a dental license.
Educational Requirements
IRRC requested the basis for reducing the required number of hours of instruction and clinical experience in § 33.336 (relating to requirements for restricted permit I) from 80 to 60, and for reducing the required number of hours of instruction and clinical experience from 40 to 14 in § 33.337. These reductions were done to comply with changes to the American Dental Association's (ADA) Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry (Guidelines).
BLS/ACLS/PALS
The HPLC noted that the requirement in Act 135 that assistants be certified in cardiopulmonary resuscitation (CPR). The Committee sought clarification that Basic Life Support (BLS) includes CPR. BLS generally includes adult, child and infant CPR, as well as rescue breathing for those persons who have stopped breathing but are not in cardiac arrest, and training on foreign body airway obstruction and the use of automatic external defibrillators.
C. Richard Bennett, D.D.S., Ph.D., a teacher of dental anesthesiology for the past 37 years, commented that the training received by dental anesthesiologists far exceeds that obtained in an Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS) course. Dr. Bennett questioned ''why the state insists on installing a false sense of security by requiring that dentists be trained in ACLS,'' believing that this will allow dentists to manage catastrophic emergencies such as cardiac arrests. Dr. Bennett commented that with proper patient evaluation, selection and attentive patient monitoring, catastrophic emergencies such as cardiac arrest should be preventable. The Board agrees that proper patient evaluation, selection and monitoring are of utmost importance in the administration of anesthesia in dental offices, which is one reason the final-form rulemaking is needed. The Board has required all dentists who want to obtain permits to deliver anesthesia to adult and pediatric patients to hold current certifications in ACLS and PALS as a minimum standard. Certainly many dental professionals in this Commonwealth obtain more advanced training in this area and are to be commended.
Recordkeeping Requirements
The HPLC pointed out that Act 135 requires dentists to maintain records of the physical evaluation, as well as records of the medical history and type of anesthesia utilized, but the proposed rulemaking was silent with respect to this requirement. IRRC also noted that the rulemaking is silent regarding recordkeeping requirements for peer review organizations. Current § 33.209 (relating to preparing, maintaining and retaining patient records) requires dentists to maintain a dental record for each patient that accurately, legibly and completely reflects the evaluation and treatment of the patient. It further requires a description of all treatment and services rendered and information with regard to any controlled substances or other drugs prescribed, administered or dispensed. Section 33.209(a)(7) specifically requires information with regard to the information of local anesthesia, nitrous oxide, oxygen analgesia, conscious sedation or general anesthesia. Section 33.209(b) requires that a patient's dental record be retained by a dentist for a minimum of 5 years from the date of the last dental entry. IRRC recommended that the proposed rulemaking specify how long records must be maintained and in what form, include deep sedation in § 33.209, and insert cross-references to § 33.209 in § 33.340 and §§ 33.340a and 33.340b (relating to duties of dentists who are restricted permit I holders; and duties of dentists who are restricted permit II holders). The Board has amended these sections to specifically mention the physical evaluation, medical history and type of anesthesia utilized, as well as adding the term ''deep sedation.''
Peer Review Organization Records
The HPLC and IRRC suggested that peer review organizations be required to maintain records of office inspections and clinical evaluations performed. The Board agrees and has updated the final-form rulemaking accordingly.
Definitions
The HPLC recommended that the addresses of organizations listed in § 33.331 (relating to definitions) be deleted as the addresses are subject to change. The Board has removed the addresses.
IRRC and PANA suggested that the Board include language in § 33.331 recognizing the successor volumes for each of the documents (American Association of Oral and Maxillofacial Surgeons (AAOMS) Parameters and Pathways 2000 Clinical Practice Guidelines for Oral and Maxillofacial Surgery, Anesthesia in Outpatient Facilities (Guidelines), AAOMS Office Anesthesia Manual (Manual), American Academy of Pediatric Dentistry (AAPD) Guidelines for the Elective Use of Conscious Sedation, Deep Sedation and General Anesthesia in Pediatric Dental Patients (Guidelines) and ADA Guidelines) so it is not necessary to revise the regulation each time a manual or set of guidelines is updated. The Board appreciates that this option would certainly be easier, but in the interest of providing specific notice to permitholders and mindful of the cautionary instruction of the Commonwealth Court in Watkins, the Board believes that the sounder choice is to specify the edition to be used in the evaluation process. Further, the Board believes that its review and approval of any successor editions will assure that changes in standards conform to the legislative intent of Act 135.
IRRC suggested the Board revise the definition of ''physician'' to be consistent with the definition in the Medical Practice Act of 1985 (63 P. S. §§ 422.1--422.51a). The PSA suggested the following definition of 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.'' The Board has adopted the PSA's definition of: physician. The Board was concerned that the definition of physician contained in the Medical Practice Act of 1985 was too broad.
IRRC suggested that the definition of ''communications equipment'' be revised for clarity purposes. The Board has revised the definition and added examples in an attempt to clarify that each operating room in which anesthesia is administered must have equipment capable of being utilized by voice, video or electronic data transmission to elicit a response in an emergency.
IRRC suggested that the Board define the term ''authorized agent.'' The Board has defined ''authorized agent'' as ''any organization or individual that the Board has officially authorized to act as its agent in carrying out the mandates of the Board, The Dental Law or this chapter.'' This definition is broad enough to encompass peer evaluation organizations, independent contractors that may be identified through the RFP process or inspectors and investigators acting through the Department's Bureau of Enforcement and Investigation.
Dentist Administering Anesthesia in State or Federal Facility
IRRC suggested that § 33.332(b) (relating to requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia) be amended by inserting ''for dental procedures'' after ''nitrous oxide/oxygen analgesia'' for clarity. The PSA recommends the following changes: ''(b) Permit not required for administration of anesthetic modality for dental procedures 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 for dental procedures in a state or federally regulated facility other than a dental office, and a permit issued under this subchapter does not permit the administration of general anesthesia, deep sedation, conscious sedation, or nitrous oxide/oxygen analgesia for non-dental procedures.'' The PDA recommends § 33.332(b) be amended by inserting the words ''for dental procedures'' prior to '' . . . in a State or Federally regulated facility other than a dental office . . .''
This final-form rulemaking establishes the requirements for licensed dentists to administer anesthesia in dental offices. Subsection (b) is meant to acknowledge the fact that the administration of anesthesia by dentists or other health care professionals in facilities such as general and special hospitals and ambulatory surgical facilities is regulated by the Department of Health and is outside of the scope of these regulations. The regulations of the Department of Health contemplate that a dentist anesthetist may provide anesthesia services for practitioners as diverse as surgeons, obstetricians, dentists, podiatrists and so forth. See 28 Pa. Code § 123.7 (relating to dental anesthetist and nurse anesthetist qualifications). Therefore, the Board has declined to adopt this suggestion.
Proof of Successful Clinical Evaluations/Office Inspections
IRRC questioned why an applicant for an initial permit was required to submit an ''original letter'' from a peer review organization. The Board has amended this section to require documentation from the peer review organization that indicates whether the applicant has satisfactorily completed the clinical evaluation and office inspection.
IRRC also questioned why a ''written report of the results of the clinical evaluation/office inspection'' is also required, if the applicant produces a letter demonstrating satisfactory completion of the clinical evaluation/office inspection. A written report of the results is required because Act 135 specifically requires a written report of the results of all inspections and evaluations (emphasis added). See section 11.2(b)(1) of the act. In addition, the requirement will assist the Board in assuring that the inspections and evaluations are conducted by the peer review organizations in conformance with the regulations and the guidelines.
IRRC noted that under § 33.336e(b) (relating to confidentiality of peer evaluation reports), a peer review organization is required to notify the Board ''as to whether the clinical evaluation and office inspection report has been accepted or rejected by the peer evaluation organization.'' IRRC suggested that the language be changed to reflect that the applicant has ''successfully completed the clinical evaluation/office inspection'' to clearly reflect its intent. The Board agrees and has inserted this clarification. The Board has also added language that clarifies the requirement that the peer evaluation organization must submit a written report of the results of all inspections and evaluations.
Guidelines for Clinical Evaluations and Office Inspections
PANA suggested omitting the AAPD and the AAOMS Guidelines and model compliance in accordance with the ADA Guidelines, as in most other states. The organization suggested that the regulations would require dentists and anesthesia providers to be familiar with up to three sets of guidelines, and it is unclear under which circumstances one guideline would prevail over another. The Board believes that the regulations clearly specify that an OMS applicant for an unrestricted or restricted permit I must conform to the AAOMS standards for adult and pediatric patients. A general dentist applicant must conform to the ADA Guidelines for adult patients and the AAPD Guidelines for pediatric patients. Therefore, an OMS would only need to be familiar with one set of guidelines. A general dentist who administers anesthesia to both adult patients and pediatric patients would need to be familiar with two sets of guidelines. When those guidelines and these regulations conflict, the regulations would control. The Board has reviewed all of the guidelines and feels that this requirement is appropriate and provides clear guidance to permitholders and applicants.
IRRC requested the reason a separate attestation for unrestricted permitholders and restricted permit I holders was necessary under § 33.336a(b). The Board has required the attestation as additional assurance that the appropriate guidelines will be followed. The attestation will be part of the application form and will not impose an undue burden on applicants.
Equipment Maintenance
IRRC and the PSA suggested that the renewal applicant be required to show that equipment has been properly maintained, as well as calibrated in § 33.338(b)(4) (relating to expiration and renewal of permits) and § 33.340(a)(9). The PDA recommends that § 33.338(b)(4) be amended by the words ''and maintained'' after '' . . . properly calibrated.'' The PDA believes that periodic preventive maintenance, as well as calibration, is an accepted standard of practice and should apply to equipment in dental offices. The Board has added a maintenance requirement to all affected sections of the regulations.
The HPLC noted that under Act 135, nonpermitholders shall certify that the equipment used is in compliance with the safety measures adopted in the act and that § 33.341(a)(5) (relating to duties of dentists who are not permitholders) as proposed merely requires the non-permitholder to verify with the permitholder that the equipment meets the statutory standards regarding safety. This section requires that a nonpermitholder provide a written certification to the Board that the office complies with the equipment and facility requirements of the regulations have been met. The Board has amended this section to require the nonpermitholder to obtain written certification from the permitholder that all monitoring equipment and equipment used to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia is present in the non-permitholder's office, is properly installed, maintained and calibrated and that monitoring equipment is being used during the administration of general anesthesia. The nonpermitholder shall also receive a written certification that the permitholder has satisfactorily completed a clinical evaluation and the equipment transported to the nonpermitholder's office has been inspected as required.
One commentator asked why so much emphasis is placed on calibration of a nitrous oxide machine, while no mention of calibration a general anesthesia machine or a vaporizer is made. The regulations include a requirement that all monitoring equipment and all equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia be installed, calibrated and maintained according to the equipment manufacturer's guidelines, contain a fail-safe system and be in proper working order. However, this comment brought to light a revision needed in § 33.338 (relating to expiration and renewal of permits), which required an attestation on the biennial renewal notice regarding the installation, calibration and maintenance of nitrous oxide/oxygen analgesia equipment, but failed to mention equipment used to administer general anesthesia, deep sedation or conscious sedation. This section has been revised to require an attestation to that effect covering all of these equipment types, as applicable to the level of permit.
Medical History and Physical Evaluation
IRRC suggested that § 33.340(a)(1) be amended to specify that the permitholder must take the medical history and conduct the physical evaluation, subsection (a)(12) should be deleted and the same clarification made in §§ 33.340a(a)(1) and 33.340b(a)(1). The PSA also commented regarding section 1 of Act 135, which amends section 11.2 of the act and requires permitholders to conduct the physical evaluation. The PSA points out that State hospitals and ambulatory surgical facilities require that physicians perform the physical evaluation and take the medical history, and recommends that § 33.340(a)(12) be amended by adding ''or a physician'' and deleting ''CRNA.'' The Board agrees with IRRC that Act 135 requires the permitholder who administers the anesthesia to take the medical history and conduct the physical evaluation. Therefore, the regulations have been amended to meet that requirement. The scope of these regulations does not extend to hospitals or ambulatory surgical facilities, therefore, the Board has declined to adopt the PSA's suggestion.
Auxiliary Personnel
IRRC requested clarification of the term ''auxiliary personnel'' in § 33.340a(3). Auxiliary personnel are defined in § 33.1 (relating to definitions) as ''persons who perform dental supportive procedures authorized by the act and this chapter under the general or direct supervision of a dentist.'' The Board has amended the final-form rulemaking to make it clear that auxiliary personnel assist the permitholder in the administration of anesthesia, and that they must be trained to carry out the tasks delegated to them, provided that those tasks do not involve the actual administration of the anesthesia.
Person Dedicated Solely to Anesthesia Administration/Monitoring
IRRC requested clarification as to why § 33.340(a)(8) requires that general anesthesia or deep sedation administered to a pediatric patient be administered by a person dedicated solely to the administration and monitoring of anesthesia. Michael G. Warfel, Vice President, Government Affairs, Highmark, expressed a general concern that the individual designated as the ''anesthetizer/sedator/monitor'' is the same person as the ''dentist/operator'' and that this concern is heightened in pediatric dental cases. He recommends that two distinct providers perform these services for all patients, not just pediatric patients. Michael Warfel suggested that true anesthesia, under which the patient is actually paralyzed and cannot breathe on his own, requires a separate anesthetist from the provider. The PSA recommends that the standard levels of practice within the medical community should be maintained in dental practice as well, and recommends that any patient under general anesthesia or deep sedation, no matter what their age, should have the anesthetic administered by someone dedicated solely to their monitoring and anesthetic administration. Conversely, the PDA recommends deleting § 33.340(a)(8) entirely, questioning why this is a requirement only for unrestricted permitholders who have completed postgraduate programs that conform with Part II of the ADA Guidelines, when these practitioners have the most extensive training in the administration of anesthesia. The PDA believes that this requirement is impractical and will hinder dental patients' access to care. The Board believes that the regulations adequately protect the health and safety of an adult patient without requiring a separate person dedicated to administering and monitoring anesthesia. Pediatric patients, however, can present more difficulties with anesthesia, and therefore the regulations require a separate provider whenever general anesthesia or deep sedation is administered to a pediatric patient.
Inspection of Nonpermit Holder Office and Equipment Transported There
IRRC commented that § 33.340(a)(10) requires that nonpermitholders' offices and equipment transported to the nonpermitholder's office be inspected by an approved peer review organization. IRRC requested clarification as to when the transported equipment was to be inspected since, it would not necessarily be in the non-permitholder's office at the time of the office inspection. With regard to § 33.341(a)(2), IRRC, the PDA and Dr. Laverick suggested that the inspection of the non-permitholder's office is not necessary. They believe that the inspection of the permitholder's equipment is sufficient, and note that Act 135 does not require inspections of nonpermitholders' offices. IRRC and the PDA opined that the permitholder should be responsible for ensuring that all appropriate equipment and facility requirements are met. IRRC and the PDA suggest that the provision in § 33.341(a)(5) requiring the nonpermitholder to verify with the permitholder that the equipment is installed properly and calibrated should be deleted as only permitholders should be responsible for verifying that the standards are met. IRRC and the PDA were also concerned that this subsection did not specify what type of verification is required. The HPLC suggested that the verification be in writing.
The PDA recommends an initial process when itinerant anesthesia providers are evaluated and their equipment is inspected and certified before they visit multiple nonpermitholders' offices and that the nonpermitholder's office is not inspected. The PDA suggests that to subsequently coordinate an inspection and evaluation simultaneously with each nonpermitholders' request for an itinerant's services would needlessly delay dental treatment and compromise patients' oral health and that this will be particularly detrimental to children and special needs patients who often require immediate care. The PDA also contends that requiring redundant inspections of the same mobile equipment in different non-permitholder's offices would also be too costly for the non-permitholder and it would be more cost-effective to have the unrestricted permitholder submit verification for each non-permitholder's office that equipment standards are met, and that auxiliary office personnel have been trained appropriately by the permitholder. This process will not disrupt the patient's ability to access dental care in a timely manner. Nonitinerant permitholders are not required to be reinspected each time they experience turnover of staff that assist in the administration of anesthesia. In a similar fashion, the permitholder is charged with training the new staff. The PDA also recommends deletion of § 33.341(a)(5), which requires the nonpermit- holder to verify with the permitholder that all monitoring equipment is properly installed and calibrated, because only permitholders should have to verify that the standards for equipment are met.
The Board has amended these sections to require itinerant permitholders to satisfactorily complete a clinical evaluation, and to require the equipment transported to nonpermitholders' offices be inspected. As part of the clinical evaluation, the permitholder would be required to certify that each office location has the equipment required by the regulations and that the staff has been properly trained to handle anesthesia-related emergencies. This eliminates the need for redundant inspections of every office in which an itinerant permitholder provides services. In addition, the regulations have been amended to require the nonpermitholder to receive a written certification from the permitholder that the equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia and all monitoring equipment is present, properly installed, maintained and calibrated and in proper working order. In addition, the nonpermitholder shall receive a written certification from the permitholder that the permitholder has satisfactorily completed a clinical evaluation and the equipment transported to the non-permitholder's office has satisfactorily passed an inspection.
Certified Registered Nurse Anesthetists (CRNAs)
IRRC points out that § 33.340a(a)(4)(i) requires CRNAs to perform under the ''direct on-premises supervision of the permitholder, who shall assume full responsibility for the performance of the duties.'' The same language appears in § 33.340a(3)(ii). IRRC questioned the need for these provisions since the State Board of Nursing regulations specify supervision requirements applicable to CRNAs in § 21.17(3) and (4) (relating to anesthesia). IRRC suggested that the Board amend these sections to cross-reference the supervision requirements for CRNAs. PANA sees the regulations as providing a disincentive to utilize CRNAs to administer anesthesia by requiring dentists to obtain the same permit level while working with a CRNA that he must obtain if administering anesthesia personally but not requiring this when a dentist utilizes an anesthesiologist or another permitted dentist. PANA recommends removing the requirement that CRNAs be under the direct supervision of the dentist in §§ 33.340(a)(4)(i) and (ii) and 33.340a(a)(4)(i) and (ii).
The Board has the authority to specify the requirements for CRNAs practicing under a dentist's anesthesia permit. Permits are issued to dentists to administer anesthesia on an out-patient basis in dental offices. CRNAs practicing in a dental office setting are practicing under the dentist's permit, that is, they are delegated the duties of administering anesthesia by the dentist who holds the permit. Since 1988, the Board's regulations have required CRNAs to perform their anesthesia administration duties under the direct on-premises supervision of the permitholder, who assumes full responsibility for the performance, and do not perform duties beyond the scope of the permitholder's authority. Therefore, the Board has declined to adopt PANA's suggestion.
Renewal Fees
IRRC questioned why renewal fees for permits under this subchapter are twice as much as the initial issuance fees. In general, the fees for initial issuance of licenses and permits reflect the actual cost of processing the applications. However, the bulk of the Board's revenues comes from renewal fees for licenses and permits. These fees are set at a level that supports the overall operations of the Board, including administrative costs, legal expenses and enforcement and investigation. The Board has proposed rulemaking increasing renewal fees across all categories of licenses and permits, published at 34 Pa.B. 5596 (October 9, 2004), in which they proposed an increase in the renewal fee for restricted permit II to $50. That increase is also incorporated in this final-form rulemaking.
General Impact of the Final-Form Rulemaking
Dr. Bennett commented that the proposed rulemaking, with the emphasis on sophisticated monitors, are unduly restrictive, confusing and will not contribute to patient safety. Dr. Laverick suggested that the proposed rulemaking would limit access to dental care to groups with the greatest need, that is, ''dental phobic'' individuals with special physical and mental needs and fearful pediatric patients. He opined that the proposed rulemaking would allow these patients unfettered access to care in offices of OMSs, as they should, but impose excessive or redundant requirements for these same patients treated in the offices of general dentists. He argues that as these patients will or can only have dental treatment if they are deeply sedated or anesthetized and if the only venue for this service is an OMS, the dental treatment most often provided will be extraction.
In response, the Board notes that the final-form rulemaking has been driven primarily by the Watkins case, in which Commonwealth Court found the requirement for ''appropriate monitoring equipment'' to be unconstitutionally vague, and the requirements of Act 135. The Board has endeavored to focus its regulatory efforts on defining the term ''appropriate monitoring equipment'' and on a combined clinical evaluation and office inspection of unrestricted and restricted permit I holders based upon standards which it believes will provide the best public protection while not unduly restricting access to care.
E. Description of Amendments
The amendments to Subchapters B and C (relating to licensure of dentists and dental hygienists; and minimum standards of conduct) and Subchapter E make substantive and editorial changes to §§ 33.110, 33.209 and 33.331--33.342.
§ 33.110. Volunteer license.
In response to comments received from the HPLC and IRRC, this section has been amended to reference updated permit requirements mandated by Act 135 and to apply those requirements to dentists who hold volunteer licenses.
§ 33.209. Preparing, maintaining and retaining patient records.
Requirements for maintaining patient records related to the administration of anesthesia has been updated to include Act 135 requirements.
§ 33.331. Definitions.
In response to comments received, the definitions have been amended to delete addresses for the AAOMS and the AAPD, which are subject to change. In addition, a definition for the term ''authorized agent'' has been added. The definition of ''communications equipment'' has been amended in the interest of clarity and examples were added. The definition of ''peer evaluation organization'' was amended to cross reference § 33.336b. The definitions for ''clinical evaluation'' and ''office inspection'' were amended to clarify that OMSs will be inspected and evaluated in accordance with the AAOMS Manual and Guidelines and that general dentists will be inspected and evaluated in accordance with the ADA Guidelines (for adult patients) and the AAPD Guidelines (for pediatric patients). Finally, the definition of physician was amended as recommended by the PSA.
§ 33.332. Requirement of permit to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia.
This section clarifies that a permit is required to administer deep sedation in a dental office.
§ 33.333. Types of permits.
This section clarifies that an unrestricted permit is required to administer deep sedation and would create a new type of permit, a temporary permit, which is limited to 1 year, as required by Act 135.
§ 33.334. Application for permit.
This section makes permit application requirements applicable to permission to administer deep sedation and to the temporary permit.
§ 33.335. Requirements for unrestricted permit.
As proposed, this section removes one of the three possible requirements that must be met for securing an unrestricted permit, specifically that of having administered general anesthesia on a regular basis in the course of dental practice for 5 years prior to January 1, 1986. The 1985 ''grandfathering'' clause of section 11.2(b) of the act tracked in the regulation is no longer necessary.
This section also increases the time required in a postgraduate program for advanced training in anesthesiology from 1 to 2 years to conform to the ADA's Guidelines.
§ 33.336. Requirements for restricted permit I.
This section removes one of the two possible requirements for securing a restricted permit I, specifically that of having administered conscious sedation on a regular basis in the course of dental practice for 5 years prior to January 1, 1986. As described previously, that requirement is no longer necessary.
This section also reduces the number of hours of undergraduate or postgraduate didactic instruction and clinical experience in a program conforming to Part I or III of the ADA Guidelines.
§ 33.336a. Requirements for unrestricted permit and restricted permit I.
Subsection (a) requires all initial unrestricted and restricted I permit applicants to have satisfactorily completed an office inspection and clinical evaluation conducted by an approved peer evaluation organization. Beginning April 1, 2005, all renewal applicants shall complete an office inspection and clinical evaluation for permit renewal. If an applicant can demonstrate satisfactory completion of an office inspection and clinical evaluation within the 6 years preceding April 1, 2005, the office inspection and clinical evaluation may be waived.
This subsection requires all renewal applicants to satisfactorily complete an office inspection and clinical evaluation every 6 years. Subsection (a)(4) has been amended based on comments received to require that applications for initial or renewal permits must contain ''documentation'' from the peer review organization that conducted the office inspection and clinical evaluation evidencing the applicant's satisfactory completion of the office inspection and clinical evaluation.
Subsection (b) requires an OMS applicant to attest that the administration of anesthesia to adult and pediatric patients will be conducted in conformance with standards outlined in the AAOMS Guidelines and Manual. It requires a general dentist applicant to attest that the administration of anesthesia to adult patients would be conducted in accordance with the ADA Guidelines and that the administration of anesthesia to pediatric patients would be conducted in conformance with the AAPD Guidelines.
Under subsection (c), applicants are required to have successfully completed and maintained current certification in ACLS prior to the administration of anesthesia to an adult patient, and certification in PALS prior to the administration of anesthesia to a pediatric patient.
Subsection (d) provides that as of April 1, 2005, applicants for unrestricted permits are required to complete 15 hours of Board approved courses related to general anesthesia and deep sedation, and restricted permit I applicants would have to complete 15 hours of Board approved courses related to conscious sedation. These continuing anesthesia education hours are credited toward the permitholder's regular continuing education requirement.
§ 33.336b. Approved peer evaluation organizations for administering clinical evaluations and office inspections.
This section specifies peer evaluation organizations approved by the Board for conducting clinical evaluations and office inspections. The Board initially has approved the AAOMS and the PSOMS. Other organizations may apply to the Board for approval to serve as an organization that conducts clinical evaluations and office inspections. Based on comments received, this section has been amended to include restricted permit I holders as potential peer evaluators. However, the Board has determined that a restricted permit I holder may only conduct office inspections and clinical evaluations of restricted permit I holders and applicants when part of a team including at least one unrestricted permitholder.
Subsection (b) outlines factors the Board will consider in approving an organization. This subsection has been amended to require that approved peer evaluation organizations agree to maintain records of office inspections and clinical evaluations for at least 5 years. It has also been amended to require peer evaluation organizations to utilize teams of two inspectors for conducting office inspections and clinical evaluations.
§ 33.336c. Standards for office inspections and clinical evaluations.
This section has been amended to clarify that office inspections and clinical evaluations will be conducted in accordance with the AAOMS Manual and 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.
This section requires peer evaluators to be licensed dentists and be independent from, and have no conflict of interest with, the dentist or dental practice being reviewed. This section has been amended to include restricted permit I holders as peer evaluators, but only when part of a team consisting of at least one unrestricted permitholder.
§ 33.336e. Confidentiality of peer review reports.
This section provides that office inspection and clinical evaluation reports and related information remain confidential except when included in the permit application to the Board. Subsection (b) has been amended to clarify that the peer evaluation organization must submit a written report of the results of all inspections and evaluations and notify the Board within 30 days to document whether the applicant has successfully completed the office inspection and clinical evaluation. Subsection (c) has been added to include a requirement that the peer evaluation organization immediately notify the Bureau 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.
§ 33.337. Requirements for restricted permit II.
This section removes one of the two possible requirements that must be met for securing a restricted permit II, specifically that of having administered nitrous oxide/oxygen analgesia on a regular basis in the course of dental practice for 5 or more years prior to January 1, 1986, for the reasons set forth previously. Also, the number of required hours of undergraduate or postgraduate didactic instruction and clinical experience in a conforming program is reduced from 40 to 14 to comply with changes to the ADA's Guidelines for Teaching the Comprehensive Control of Pain and Anxiety in Dentistry.
Subsections (b) and (c) have been amended based on comments received to require initial permit applicants to certify and renewal permit applicants to provide an attestation that the equipment used to administer nitrous oxide/oxygen analgesia is properly calibrated and maintained, contains a fail-safe system and is in working order.
§ 33.337a. Requirements for temporary permit.
This section requires an applicant for a temporary permit of any type to include with the application proof that the applicant possesses the qualifications for the permit requested. Temporary permits expire in 1 year and are not renewable.
§ 33.338. Expiration and renewal of permits.
Renewal requirements have been amended to include proof of current certification in ACLS or PALS or both for unrestricted and restricted I permits; an attestation that any equipment used to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia has been installed, calibrated and maintained according to the equipment manufacturer's guidelines and contains a failsafe system; proof of compliance with anesthesia continuing education requirements; and proof of compliance with office inspection and clinical evaluation requirements.
§ 33.339. Fees for issuance of permits.
Permit fees have been amended as follows: initial unrestricted permits and restricted permit I fees is $100 and the initial restricted permit II fee remains $15. The renewal unrestricted permit and restricted permit I fee is $200. The Board proposed to increase the renewal restricted permit II fee from $15 to $50 in proposed rulemaking published at 34 Pa.B. 5596. In response to comments received, the Board has incorporated that increase in this final rulemaking package.
§ 33.340. Duties of dentists who are unrestricted permitholders.
This section establishes the standards for the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia by unrestricted permitholders. It lists the equipment and supplies that are required in the office and requires that auxiliary personnel who assist the permitholder must be currently certified in BLS. The section has been amended based on comments received by the Board to clarify auxiliary personnel may assist the permitholder so long as they are trained to perform the duties that the permitholder delegates to them, but are not permitted to actually administer the anesthesia. This section has also been amended to clarify that monitoring equipment and the equipment used to administer general anesthesia, deep sedation, conscious sedation and nitrous oxide/oxygen analgesia is installed, maintained, calibrated and in proper working condition.
The requirements for itinerant permitholders, that is, permitholders who travel to the offices of non-permitholders for the purpose of administering general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia, have been amended to require itinerant permitholders to complete a clinical evaluation and the equipment they transport to nonpermitholders' offices must be inspected. As part of the clinical evaluation and inspection, the permitholder is expected to certify that each office in which general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia is administered meets the equipment requirements of this subchapter and that the staff is properly trained to handle anesthesia-related emergencies.
Finally, this section was amended to clarify that the permitholder shall conduct the patient medical history and patient physical evaluation as required by Act 135 and to provide a cross-reference to § 33.209.
§ 33.340a. Duties of dentists who are restricted permit I holders.
This section establishes the standards for the administration of conscious sedation or nitrous oxide/oxygen analgesia for restricted permit I holders. It has been amended in substantially the same manner as § 33.340.
§ 33.340b. Duties of dentists who are restricted permit II holders.
The requirements for restricted permit II holders have been amended to require that monitoring equipment and equipment used to administer nitrous oxide/oxygen analgesia be installed, maintained and calibrated according to the equipment manufacturers' guidelines, contain a fail-safe system and be in proper working condition. In addition, a cross-reference to § 33.209 has been added.
§ 33.341. Duties of dentists who are not permitholders.
This section establishes the duties of dentists who are not permitholders, but who allow permitholders to administer general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in their offices. In response to comments to the proposed rulemaking, this section has been amended to require the non-permitholder to certify that the dental office meets the equipment and facility requirements prescribed in this subchapter. In addition, rather than verify with the permitholder that the equipment used by a permitholder is properly installed, maintained and calibrated, the regulations now require that a nonpermitholder receive a certification from the permitholder to that effect prior to allowing the administration of anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia in the office. In addition, the nonpermitholder shall obtain a certification from the permitholder that the permitholder has successfully completed a clinical evaluation and that the equipment transported to the non-permitholder's office has been inspected as required. A cross-reference to the definition of ''physician'' in § 33.331 has been added.
§ 33.342. Inspection of dental offices.
This section allows inspections of dental offices by Board authorized agents as defined in § 33.331 to determine if the equipment and facilities requirements have been met. This section anticipates that the Board may, through its authorized agents, conduct inspections when a death or injury related to the administration of general anesthesia, deep sedation, conscious sedation or nitrous oxide/oxygen analgesia has occurred; when a complaint has been filed alleging that a dentist or dental office is not in compliance with this subchapter; or when a reasonable belief exists that conditions exist in the office that pose a danger to the health or safety of the public. It also allows for a reinspection to take place within 30 days of an inspection finding deficiencies.
F. Fiscal Impact and Paperwork Requirements
Some of the provisions of this final-form rulemaking will have a fiscal impact upon permitholders. Fees for an office inspection and clinical evaluation will be set by the approved peer evaluation organizations. Although the fee amounts are not known at this time, the Board upon information provided to it estimates that the combined fee for the office inspection and clinical evaluation will be in the $700 to $900 range. The one-time initial permit fee for these permitholders is increased from $15 to $100. The permit renewal fees for both unrestricted and restricted permit I holders will be $200. The initial permit fee for restricted permit II holders remains the same ($15), while the renewal fee for these permitholders is being increased to $50. In addition, requirements for current certification in ACLS and some additional required monitoring equipment may entail increased costs to permitholders. Act 135 permits the Board to ''grandfather'' the successful clinical evaluation and office inspection of an applicant within the last 6 years, and thereafter a clinical evaluation and office inspection is required once every 6 years. This will lessen the initial fiscal impact upon permit applicants. If the cost of a clinical evaluation and office inspection is an average of $800, the cost per year is $133, which the Board believes is a reasonable amount. At this stage, it is not possible to estimate the fiscal impact with precision.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on March 30, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 1949, to IRRC and the Chairpersons of the HPLC and the SCP/PLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on March 30, 2005, the final-form rulemaking was approved by the HPLC. On April 13, 2005, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on April 14, 2005, and approved the final-form rulemaking.
I. Contact Person
Additional information can be obtained by contacting Cynthia K. Montgomery, State Board of Dentistry, P. O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7200.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of proposed rulemaking published at 34 Pa.B. 1949.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing act identified in Part B of this preamble.
K. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 33, are amended by amending §§ 33.110, 33.209, 33.331--33.336, 33.337, 33.338--33.340, 33.341 and 33.342 and by adding §§ 33.336a--33.336e, 33.337a, 33.340a and 33.340b to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect on publication in the Pennsylvania Bulletin.
VEASEY B. CULLEN, Jr., D.M.D.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 35 Pa.B. 2073 (April 30, 2005).)
Fiscal Note: Fiscal Note 16A-4614 remains valid for the final adoption of the subject regulations.
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