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        PRIOR PRINTER'S NO. 1636                      PRINTER'S NO. 3386

THE GENERAL ASSEMBLY OF PENNSYLVANIA


HOUSE BILL

No. 1394 Session of 1999


        INTRODUCED BY BLAUM, CIVERA, GEORGE, SCHRODER, HALUSKA, TIGUE,
           YOUNGBLOOD, HASAY, WALKO, E. Z. TAYLOR, TRELLO, STABACK,
           MELIO, MUNDY, HARHAI, YUDICHAK, BELARDI, VEON AND SAYLOR,
           APRIL 26, 1999

        AS REPORTED FROM COMMITTEE ON PROFESSIONAL LICENSURE, HOUSE OF
           REPRESENTATIVES, AS AMENDED, APRIL 18, 2000

                                     AN ACT

     1  Amending the act of May 1, 1933 (P.L.216, No.76), entitled "An
     2     act relating to dentistry; defining and providing for the
     3     licensing and registration of dentists and dental hygienists,
     4     and for the revocation and suspension of such licenses and
     5     registrations, subject to appeal, and for their
     6     reinstatement; defining the powers and duties of the State
     7     Dental Council and Examining Board and the Department of
     8     Public Instruction; providing penalties; and repealing
     9     existing laws," further providing for definitions and for      <--
    10     anesthesia.

    11     The General Assembly of the Commonwealth of Pennsylvania
    12  hereby enacts as follows:
    13     Section 1.  Section 2 of the act of May 1, 1933 (P.L.216,      <--
    14  No.76), known as The Dental Law, is amended by adding a
    15  definition to read:
    16     Section 2.  Definitions.--* * *
    17     "Pediatric dental patient" means a dental patient who is
    18  under nine years of age.
    19     Section 2.  Section 11.2 of the act, added December 20, 1985
    20  (P.L.513, No.118), is amended to read:


     1     Section 11.2.  Anesthesia.--(a)  Prior to January 1, 1987,
     2  the board shall promulgate regulations which:
     3     (1)  Establish minimal training and education or
     4  certification for the issuance of permits to dentists to
     5  administer general anesthesia on an outpatient basis. Such
     6  regulations shall include a requirement of a minimum of one year
     7  in an approved program of advanced training in anesthesiology
     8  and related academic subjects, beyond the undergraduate dental
     9  school level.
    10     (2)  Establish further requirements relating to the use of
    11  general anesthesia, including, but not limited to, the
    12  collection of permit fees, the collection of biennial license
    13  and license renewal fees and the conducting of workplace
    14  inspections.
    15     (3)  Establish minimal training and education for the
    16  issuance of permits to dentists to administer conscious sedation
    17  on an outpatient basis. Such regulations shall include a minimum
    18  period of time of didactic instruction and clinical experience
    19  in an accredited educational institution or program.
    20     (4)  Establish further requirements relating to the use of
    21  conscious sedation, including, but not limited to, the
    22  collection of permit fees, the collection of biennial license
    23  and license renewal fees and the conduct of workplace
    24  inspections.
    25     (5)  Establish minimal training and education for the
    26  issuance of permits to dentists to administer analgesia on an
    27  outpatient basis. Such regulations shall include a minimum
    28  period of time of didactic instruction or clinical experience in
    29  an accredited educational institution or program.
    30     (6)  Establish further requirements relating to the use of
    19990H1394B3386                  - 2 -

     1  analgesia, including, but not limited to, the collection of
     2  permit fees, the collection of biennial licenses and license
     3  renewal fees and the conduct of workplace inspections.
     4     (7)  Establish fees for temporary permits which permits may
     5  be issued by the board for one year to a person whose
     6  application indicates that he possesses the necessary
     7  qualifications pending a complete processing of the application.
     8     (b)  The board may issue the appropriate permits in
     9  accordance with this section to a dentist who has been
    10  administering general anesthesia, conscious sedation agents or
    11  nitrous oxide or oxygen analgesia if the dentist submits
    12  evidence satisfactory to the board that he has been
    13  administering these agents for a period of at least five years
    14  prior to the effective date of this section and that the dentist
    15  has applied within one year of the effective date of the
    16  regulations.
    17     (c)  Prior to the administration of a general anesthetic, the
    18  written informed consent of the patient must be obtained. The
    19  consent must include a description of the procedure, its risks
    20  and possible alternative treatments.
    21     (d)  Dental procedures requiring the use of general
    22  anesthesia on a pediatric dental patient shall be performed in a
    23  hospital setting.
    24     Section 3.  This act shall take effect in 60 days.
    25     SECTION 1.  SECTION 11.2 OF THE ACT OF MAY 1, 1933 (P.L.216,   <--
    26  NO.76), KNOWN AS THE DENTAL LAW, ADDED DECEMBER 20, 1985
    27  (P.L.513, NO.118), IS AMENDED TO READ:
    28     SECTION 11.2.  ANESTHESIA.--(A)  [PRIOR TO JANUARY 1, 1987,
    29  THE] THE BOARD SHALL PROMULGATE REGULATIONS WHICH:
    30     (1)  ESTABLISH MINIMAL TRAINING AND EDUCATION OR
    19990H1394B3386                  - 3 -

     1  CERTIFICATION FOR THE ISSUANCE OF PERMITS TO DENTISTS TO
     2  ADMINISTER GENERAL ANESTHESIA ON AN OUTPATIENT BASIS. SUCH
     3  REGULATIONS SHALL INCLUDE A REQUIREMENT OF A MINIMUM OF ONE YEAR
     4  IN AN APPROVED PROGRAM OF ADVANCED TRAINING IN ANESTHESIOLOGY
     5  AND RELATED ACADEMIC SUBJECTS, BEYOND THE UNDERGRADUATE DENTAL
     6  SCHOOL LEVEL.
     7     (2)  ESTABLISH FURTHER REQUIREMENTS RELATING TO THE USE OF
     8  GENERAL ANESTHESIA, INCLUDING, BUT NOT LIMITED TO, THE
     9  COLLECTION OF PERMIT FEES, TEMPORARY PERMIT FEES, [THE
    10  COLLECTION OF BIENNIAL LICENSE AND LICENSE] BIENNIAL RENEWAL
    11  FEES, OFFICE INSPECTION FEES, CLINICAL EVALUATION FEES,
    12  EQUIPMENT STANDARDS AND THE CONDUCTING OF WORKPLACE INSPECTIONS.
    13     (3)  ESTABLISH MINIMAL TRAINING AND EDUCATION FOR THE
    14  ISSUANCE OF PERMITS TO DENTISTS TO ADMINISTER CONSCIOUS SEDATION
    15  ON AN OUTPATIENT BASIS. SUCH REGULATIONS SHALL INCLUDE A MINIMUM
    16  PERIOD OF TIME OF DIDACTIC INSTRUCTION AND CLINICAL EXPERIENCE
    17  IN AN ACCREDITED EDUCATIONAL INSTITUTION OR PROGRAM.
    18     (4)  ESTABLISH FURTHER REQUIREMENTS RELATING TO THE USE OF
    19  CONSCIOUS SEDATION, INCLUDING, BUT NOT LIMITED TO, THE
    20  COLLECTION OF PERMIT FEES, TEMPORARY PERMIT FEES, [THE
    21  COLLECTION OF BIENNIAL LICENSE AND LICENSE] BIENNIAL RENEWAL
    22  FEES, OFFICE INSPECTION FEES, CLINICAL EVALUATION FEES,
    23  EQUIPMENT STANDARDS AND THE [CONDUCT] CONDUCTING OF WORKPLACE
    24  INSPECTIONS.
    25     (5)  ESTABLISH MINIMAL TRAINING AND EDUCATION FOR THE
    26  ISSUANCE OF PERMITS TO DENTISTS TO ADMINISTER NITROUS
    27  OXIDE/OXYGEN ANALGESIA ON AN OUTPATIENT BASIS. SUCH REGULATIONS
    28  SHALL INCLUDE A MINIMUM PERIOD OF TIME OF DIDACTIC INSTRUCTION
    29  OR CLINICAL EXPERIENCE IN AN ACCREDITED EDUCATIONAL INSTITUTION
    30  OR PROGRAM.
    19990H1394B3386                  - 4 -

     1     (6)  ESTABLISH FURTHER REQUIREMENTS RELATING TO THE USE OF
     2  NITROUS OXIDE/OXYGEN ANALGESIA, INCLUDING, BUT NOT LIMITED TO,
     3  THE COLLECTION OF PERMIT FEES, [THE COLLECTION OF BIENNIAL
     4  LICENSES AND LICENSE] TEMPORARY PERMIT FEES, BIENNIAL RENEWAL
     5  FEES, EQUIPMENT STANDARDS AND THE CONDUCT OF WORKPLACE
     6  INSPECTIONS.
     7     [(7)  ESTABLISH FEES FOR TEMPORARY PERMITS WHICH PERMITS MAY
     8  BE ISSUED BY THE BOARD FOR ONE YEAR TO A PERSON WHOSE
     9  APPLICATION INDICATES THAT HE POSSESSES THE NECESSARY
    10  QUALIFICATIONS PENDING A COMPLETE PROCESSING OF THE
    11  APPLICATION.]
    12     (B)  [THE BOARD MAY ISSUE THE APPROPRIATE PERMITS IN
    13  ACCORDANCE WITH THIS SECTION TO A DENTIST WHO HAS BEEN
    14  ADMINISTERING GENERAL ANESTHESIA, CONSCIOUS SEDATION AGENTS OR
    15  NITROUS OXIDE OR OXYGEN ANALGESIA IF THE DENTIST SUBMITS
    16  EVIDENCE SATISFACTORY TO THE BOARD THAT HE HAS BEEN
    17  ADMINISTERING THESE AGENTS FOR A PERIOD OF AT LEAST FIVE YEARS
    18  PRIOR TO THE EFFECTIVE DATE OF THIS SECTION AND THAT THE DENTIST
    19  HAS APPLIED WITHIN ONE YEAR OF THE EFFECTIVE DATE OF THE
    20  REGULATIONS.]
    21     (1)  BEGINNING APRIL 1, 2003, PRIOR TO ISSUING INITIAL
    22  PERMITS TO ADMINISTER GENERAL ANESTHESIA OR CONSCIOUS SEDATION,
    23  THE BOARD SHALL REQUIRE PERMIT APPLICANTS TO SATISFACTORILY
    24  UNDERGO CLINICAL EVALUATIONS AND OFFICE INSPECTIONS. THE BOARD
    25  MAY CONTRACT WITH DENTAL ORGANIZATIONS OR INDIVIDUALS EXPERT IN
    26  DENTAL OUTPATIENT ANESTHESIA TO PERFORM SUCH OFFICE INSPECTIONS
    27  AND CLINICAL EVALUATIONS. A WRITTEN REPORT OF THE RESULTS OF ALL
    28  INSPECTIONS AND EVALUATIONS SHALL BE PROVIDED TO THE BOARD IN A
    29  TIMELY MANNER. IF THE RESULTS OF THE EVALUATION OR INSPECTION
    30  ARE DEEMED UNSATISFACTORY, SUBSEQUENT EVALUATIONS OR INSPECTIONS
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     1  MAY BE CONDUCTED, WITHIN A REASONABLE TIME, UPON WRITTEN REQUEST
     2  OF THE APPLICANT. NO PERMIT SHALL BE ISSUED UNTIL THE APPLICANT
     3  SATISFACTORILY COMPLETES A CLINICAL EVALUATION AND OFFICE
     4  INSPECTION.
     5     (2)  BEGINNING APRIL 1, 2003, PRIOR TO ISSUING INITIAL
     6  PERMITS TO ADMINISTER NITROUS OXIDE/OXYGEN ANALGESIA, THE BOARD
     7  SHALL REQUIRE PERMIT APPLICANTS TO PROVIDE THE MAKE, MODEL AND
     8  SERIAL NUMBER OF ANY NITROUS OXIDE/OXYGEN ANALGESIA EQUIPMENT
     9  UTILIZED BY THE APPLICANT, AND CERTIFICATION THAT THE EQUIPMENT
    10  IS IN PROPER WORKING ORDER. THEREAFTER, SUCH PERMIT HOLDERS
    11  SHALL PROVIDE EVIDENCE TO THE BOARD THAT THEIR EQUIPMENT IS
    12  PROPERLY CALIBRATED, AT LEAST ONCE EVERY SIX YEARS.
    13     (3)  THE BOARD SHALL ADOPT BY REGULATION THOSE GUIDELINES,
    14  STANDARDS AND PROCEDURES NECESSARY TO PERFORM CLINICAL
    15  EVALUATIONS AND OFFICE INSPECTIONS. SUCH GUIDELINES, STANDARDS
    16  AND PROCEDURES SHALL INCLUDE, BUT NOT BE LIMITED TO, THE
    17  REQUIREMENT THAT EQUIPMENT BE MAINTAINED IN GOOD WORKING ORDER
    18  AND IN ACCORDANCE WITH THE MANUFACTURER'S SPECIFICATIONS. THE
    19  STANDARDS FOR EQUIPMENT SHALL BE UPDATED PERIODICALLY.
    20     (4)  PERMIT HOLDERS WHO TRAVEL TO OFFICE LOCATIONS OTHER THAN
    21  THEIR OWN TO ADMINISTER ANESTHESIA SHALL ENSURE THAT THE OFFICE
    22  LOCATION HAS THE EQUIPMENT REQUIRED BY BOARD REGULATION, AND
    23  THAT THE STAFF IS PROPERLY TRAINED TO HANDLE ANESTHESIA-RELATED
    24  EMERGENCIES.
    25     (5)  A LICENSEE WHO DOES NOT POSSESS A PERMIT ISSUED PURSUANT
    26  TO THIS SECTION SHALL NOT ALLOW GENERAL ANESTHESIA, CONSCIOUS
    27  SEDATION OR NITROUS OXIDE/OXYGEN ANALGESIA TO BE ADMINISTERED ON
    28  AN OUTPATIENT BASIS IN HIS OR HER DENTAL OFFICE UNLESS THE
    29  OFFICE IS IN COMPLIANCE WITH BOARD REGULATIONS, INCLUDING THOSE
    30  REGULATIONS PERTAINING TO EQUIPMENT REQUIREMENTS AND STAFFED
    19990H1394B3386                  - 6 -

     1  WITH A SUPERVISED TEAM OF AUXILIARY PERSONNEL CAPABLE OF
     2  APPROPRIATELY MANAGING PROCEDURES AND EMERGENCIES INCIDENT TO
     3  THE ADMINISTRATION OF ANESTHESIA.
     4     (6)  AS A CONDITION OF PERMIT RENEWAL FOR THE BIENNIAL
     5  RENEWAL PERIOD BEGINNING APRIL 1, 2003, PERMIT HOLDERS FOR THE
     6  ADMINISTRATION OF GENERAL ANESTHESIA AND CONSCIOUS SEDATION
     7  SHALL HAVE SATISFACTORILY UNDERGONE A CLINICAL EVALUATION AND
     8  OFFICE INSPECTION PURSUANT TO THIS SECTION. THE BOARD MAY WAIVE
     9  THIS REQUIREMENT FOR PERMIT HOLDERS WHO CAN DEMONSTRATE TO THE
    10  BOARD'S SATISFACTION THAT HE OR SHE HAS SATISFACTORILY UNDERGONE
    11  A CLINICAL EVALUATION, ADMINISTERED BY A DENTAL ORGANIZATION
    12  ACCEPTABLE TO THE BOARD, WITHIN THE SIX YEARS IMMEDIATELY
    13  PRECEDING THE EFFECTIVE DATE OF THIS CLAUSE. THEREAFTER, PERMIT
    14  HOLDERS SHALL SATISFACTORILY UNDERGO CLINICAL EVALUATIONS AND
    15  OFFICE INSPECTIONS AT LEAST ONCE EVERY SIX YEARS.
    16     (C)  BEGINNING ON APRIL 1, 2003, THE BOARD MAY ISSUE
    17  TEMPORARY PERMITS TO ADMINISTER GENERAL ANESTHESIA, CONSCIOUS
    18  SEDATION OR NITROUS OXIDE/OXYGEN ANALGESIA, WHICH SHALL BE VALID
    19  FOR ONE YEAR, TO INDIVIDUALS WHOSE APPLICATION INDICATES THAT HE
    20  OR SHE POSSESSES THE NECESSARY QUALIFICATIONS PENDING A COMPLETE
    21  PROCESSING OF THE APPLICATION. TEMPORARY PERMITS SHALL NOT BE
    22  SUBJECT TO RENEWAL.
    23     (D)  AS A CONDITION OF PERMIT RENEWAL FOR THE BIENNIAL
    24  RENEWAL PERIOD BEGINNING APRIL 1, 2003, AND ALL RENEWAL PERIODS
    25  THEREAFTER, GENERAL ANESTHESIA PERMIT HOLDERS SHALL HAVE
    26  COMPLETED FIFTEEN HOURS OF BOARD-APPROVED COURSES OF STUDY
    27  RELATED TO GENERAL ANESTHESIA AND CONSCIOUS SEDATION PERMIT
    28  HOLDERS SHALL HAVE COMPLETED FIFTEEN HOURS OF BOARD-APPROVED
    29  COURSES OF STUDY RELATED TO CONSCIOUS SEDATION. LICENSEES WHO
    30  ARE NOT PERMIT HOLDERS, BUT WHO MAINTAIN OFFICES IN WHICH
    19990H1394B3386                  - 7 -

     1  GENERAL ANESTHESIA OR CONSCIOUS SEDATION IS ADMINISTERED, SHALL
     2  HAVE COMPLETED FIVE HOURS OF BOARD-APPROVED COURSES OF STUDY
     3  RELATED TO ANESTHESIA. CONTINUING ANESTHESIA EDUCATION SHALL BE
     4  CREDITED TOWARD A PERMIT HOLDER'S OR LICENSEE'S CONTINUING
     5  EDUCATION REQUIREMENT UNDER SECTION 3(J.2) OF THIS ACT.
     6     (E)  PERMIT HOLDERS SHALL CONDUCT A PHYSICAL EVALUATION AND
     7  TAKE A MEDICAL HISTORY OF A PATIENT PRIOR TO THE ADMINISTRATION
     8  OF GENERAL ANESTHESIA, CONSCIOUS SEDATION OR NITROUS
     9  OXIDE/OXYGEN ANALGESIA, AND MAINTAIN RECORDS OF THE PHYSICAL
    10  EVALUATION, MEDICAL HISTORY AND ANESTHESIA PROCEDURES UTILIZED.
    11     (F)  PERMIT HOLDERS SHALL OBTAIN THE WRITTEN INFORMED CONSENT
    12  OF A PATIENT PRIOR TO THE ADMINISTRATION OF GENERAL ANESTHESIA,
    13  CONSCIOUS SEDATION OR NITROUS OXIDE/OXYGEN ANALGESIA. THE
    14  CONSENT SHALL INCLUDE, BUT NOT BE LIMITED TO, A DESCRIPTION OF
    15  THE PROCEDURE, ITS RISKS AND POSSIBLE ALTERNATIVE TREATMENTS. IN
    16  THE CASE OF A MINOR PATIENT, THE CONSENT SHALL BE OBTAINED FROM
    17  THE MINOR'S PARENT OR GUARDIAN.
    18     (G)  NONCOMPLIANCE WITH ANY OF THE PROVISIONS OF THIS SECTION
    19  SHALL BE CONSIDERED A VIOLATION OF THIS ACT.
    20     (H)  THE BOARD SHALL PROMULGATE THE REGULATIONS REQUIRED BY
    21  THIS SECTION WITHIN ONE YEAR OF THE EFFECTIVE DATE OF THIS
    22  SUBSECTION.
    23     SECTION 2.  THIS ACT SHALL TAKE EFFECT IN 30 DAYS.





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