Subchapter C. MINIMUM STANDARDS OF CONDUCT
AND PRACTICE

§ 33.201. Use of titles and other designations.

 (a)  Dentists, dental hygienists and expanded function dental assistants may use only the following titles when formally holding themselves out to the public as members of their respective professions:

   (1)  Dentists.

     (i)   ‘‘Doctor’’ or ‘‘Dr.’’ if the licensee’s name and a title permitted under subparagraph (ii) or (iii) follows immediately. The Board specifically prohibits the use of the word ‘‘Doctor’’ or its abbreviation except in combination with one of these titles.

     (ii)   ‘‘Dentist,’’ ‘‘Doctor of Dental Surgery,’’ ‘‘Doctor of Dental Medicine,’’ or a title such as ‘‘Orthodontist,’’ signifying a specialty recognized by the Board in which the dentist has advanced training in conformity with §  33.203(d)(1) (relating to advertising), when preceded by the licensee’s name.

     (iii)   ‘‘D.D.S.’’ or ‘‘D.M.D.,’’ when preceded by the licensee’s name.

   (2)  Dental hygienists.

     (i)   ‘‘Dental Hygienist’’ or ‘‘D. H.,’’ when preceded by the licensee’s name.

     (ii)   ‘‘Registered Dental Hygienist’’ or ‘‘R.D.H.,’’ when preceded by the licensee’s name.

   (3)  Expanded function dental assistants. ‘‘Expanded function dental assistant’’ or ‘‘EFDA’’ when preceded by the certificate holder’s name.

 (b)  In addition to the titles approved under subsection (a), licensees may use, in conjunction with their names, designations of advanced degrees earned from accredited institutions and designations of advanced professional status—such as diplomate or fellow.

 (c)  References in this section to the licensee’s or certificate holder’s name shall be interpreted to mean the name appearing on the licensee’s or certificate holder’s current license or certificate but to allow for the use of initials preceding the licensee’s or certificate holder’s surname.

   The provisions of this §  33.201 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  Dentists may use a fictitious name that is not false, misleading or deceptive.

 (b)  Dentists who wish to practice under a fictitious name shall submit to the Board a fictitious name registration and the fee specified in §  33.3 (relating to fees). The dentist who submits the registration shall be associated with the facility and shall assume responsibility for compliance with this section. The owner of the facility, if different from the applicant, shall be identified on the registration.

 (c)  Changes in the ownership of a dental facility, changes in the designation of the responsible dentist, changes in the scope of practice or changes in professional staffing, shall be reported in writing within 10 days.

 (d)  Advertisements in any medium shall include the name, as it appears on the current biennial renewal certificate, and the degree—D.D.S. or D.M.D.—of at least one licensed dentist who is associated with the dental facility. The lettering for the name of the dentist shall be at least equal in size to the lettering used for the fictitious name. The dentist referred to in this subsection and the dentist who registered to use the name under subsection (b) shall be jointly responsible for the advertisement.

 (e)  A directory listing the names of the dentists practicing at that location shall be prominently displayed in the entrance or reception area of the dental facility.

 (f)  The names of dentists who have practiced under the fictitious name shall be maintained in the records of the dental facility for at least 5 years following their departure from the practice.

 (g)  The use of the name of a dentist no longer actively associated with the practice may be continued for up to 1 year.

 (h)  Dentists who are specialists under §  33.203(d)(1) (relating to advertising) may incorporate their area of specialization in their fictitious name. A specialist in one area may include another recognized specialty area, or a nonspecialty area, in a fictitious name (examples: a specialist in orthodontics using Central Orthodontics and Pediatric Dentistry or a specialist in periodontics using Central Periodontics and Cosmetic Dentistry) only if the specialist conspicuously discloses, in every medium in which the name is used, that specialty status does not extend to the other specialty or nonspecialty area.

 (i)  Dentists who are not specialists under §  33.203(d)(1) may incorporate any area of dentistry in their fictitious name, including the recognized specialties, only if the name, in every medium in which it is used, is accompanied by the conspicuous disclosure that services are provided by a general dentist.

 (j)  A fictitious name may not include the word ‘‘clinic’’ unless the name designates a public or quasipublic facility as defined in §  33.1 (relating to definitions).

 (k)  A fictitious name may not include the word ‘‘institute’’ unless the name designates an educational or research facility.

 (l)  A fictitious name may not, by the use of plurals or otherwise, misrepresent the number of dentists practicing at a facility or the number of dentists at the facility who are specialists under §  33.203(d)(1).

   The provisions of this §  33.202 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 23, 1997, effective May 24, 1997, 27 Pa.B. 2547. Immediately preceding text appears at serial pages (223032) to (223034).

 (a)  Advertising is permitted to provide the public with a sufficient basis for making an informed selection of a dentist. For purposes of this section, the term ‘‘advertising’’ includes signs, letterheads, business cards, and printed or broadcast announcements of services to the public.

 (b)  Advertising that is false, misleading or deceptive is prohibited under section 4.1(a)(10) of the act (63 P. S. §  123.1(a)(10)). Advertising is false, misleading or deceptive if it does one or more of the following:

   (1)  Contains a material misrepresentation of fact, or omits a fact necessary to make the statement considered as a whole not materially misleading.

   (2)  Is likely to create an unjustified expectation about results the dentist can achieve.

   (3)  Compares the advertising dentist’s services with the services of other dentists unless the comparison can be factually substantiated.

 (c)  A dental advertisement in any medium shall contain the name of at least one dentist whose services are being advertised. Each dentist whose name appears in the advertisement shall assume responsibility for the advertisement and shall use the name that appears on the dentist’s current biennial renewal certificate. A dentist who advertises under a fictitious name shall comply with §  33.202 (relating to fictitious names).

 (d)  A dental advertisement in any medium may identify the dentist as a specialist in a particular area of dentistry, state that the practice is limited to a particular area of dentistry or merely designate the kinds of dental services available. In addition, the following shall be met:

   (1)  An advertisement may not hold out or imply that the dentist is a specialist in any area unless the conditions in subparagraphs (i) and (ii) are satisfied. Holding out as a specialist includes the use of the terms ‘‘specialist’’ and ‘‘limited to specialty of’’ or of words such as ‘‘endodontist’’ and ‘‘pediatric dentist,’’ which denote a practitioner of the dental specialties listed in subparagraph (i).

     (i)   The area must be recognized by the Board as a dental specialty. The Board has adopted the American Dental Association’s (ADA’s) standards for recognizing the following specialties:

       (A)   Dental public health.

       (B)   Endodontics.

       (C)   Oral and maxillofacial surgery.

       (D)   Oral pathology.

       (E)   Orthodontics.

       (F)   Pediatric dentistry.

       (G)   Periodontics.

       (H)   Prosthodontics.

     (ii)   The dentist shall have successfully completed a specialty training program approved by the ADA’s Commission on Dental Accreditation.

   (2)  A dentist who is a specialist in one area under paragraph (1) and advertises, in conjunction with the specialty, that services are provided in another recognized specialty area, or in a nonspecialty area (examples: a specialist in orthodontics announcing additional services in pediatric dentistry or a specialist in periodontics announcing additional services in placing dental implants) shall conspicuously disclose that specialty status does not extend to the other specialty or nonspecialty area.

   (3)  A specialist under paragraph (1) may not hold out or imply that general dentists associated with the practice are specialists.

   (4)  A dentist who is not a specialist under paragraph (1) may list the area in which the dentist practices or to which the practice is limited. If the advertisement identifies an area by a term that designates a recognized specialty under paragraph (1)(i), the advertisement shall conspicuously disclose that services are provided by a general dentist. For example, an advertisement that announces services in prosthodontics or oral surgery shall include the general dentist disclosure, whereas an advertisement that announces services such as crown and bridge work or extractions may omit the disclosure.

   (5)  Neither general dentists nor specialists may hold out or imply that a nonspecialty area of dentistry has specialty status. For example, dentists may not state that they specialize in or limit their practice to temporomandibular joint disorders or implantology but may announce services in, or a practice limited to diagnosing or treating temporomandibular joint disorders, or placing dental implants.

 (e)  A dental advertisement in any medium may contain the fees charged by the advertising dentist for dental services, as defined in subsection (k). If a minimum fee is advertised, the advertisement shall contain a statement disclosing that the advertised fee is the minimum fee charged for the advertised service and that the actual fee may vary depending on the degree of complexity involved in treatment. The disclosure statement shall be at least as prominent in the context of the advertisement as the fee information contained in the advertisement. If the fee information is verbal, the disclosure statement also shall be verbal and shall be at least equal to the fee information in volume, quality and duration. If the fee information is in writing, the disclosure statement also shall be in writing and shall be at least equal to the fee information in size, legibility and length.

 (f)  A dental advertisement in any medium may state that dental services, as defined in subsection (k), will be rendered free of charge.

 (g)  For at least 60 days following final publication or broadcast of an advertisement containing information about fees or free services, the advertising dentist shall neither increase the advertised fees nor charge fees for services advertised as free unless the advertisement specifically and conspicuously stated that the advertised fees or free services would be available for a shorter period of time. When a dental patient agrees, within the 60-day period or the period otherwise stated in the advertisement, to accept a treatment plan for services for which fees have been advertised, the advertising dentist may not charge a fee higher than the advertised fee, even if the services are rendered beyond the 60-day period or the period otherwise stated in the advertisement. When a dental patient

   agrees, within the 60-day period or the period otherwise stated in the advertisement, to accept a treatment plan for services advertised as free, the advertising dentist may not charge fees for services, even if the services are rendered beyond the 60-day period or the period otherwise stated in the advertisement.

 (h)  A dental advertisement in any medium may state the dentist’s office hours.

 (i)  A recorded copy of an advertisement on radio or television shall be retained for 1 year following the final broadcast of the advertisement. The dentist who is responsible for the advertisement under subsection (c) shall furnish the Board with a copy of the advertisement within 20 days of being requested to do so.

 (j)  If the narrator of a dental advertisement on radio or television is represented as a dentist, that person shall be the dentist so represented.

 (k)  This subsection contains definitions of some but not all of the various types of dental services for which fees may be advertised under subsection (e). Whenever a fee is advertised for one of the defined terms listed in paragraphs (1)—(10), the meaning of the term, as used in the advertisement, is at least as inclusive as the definition set forth in this subsection. These definitions will help ensure that commonly used terms for dental services convey the same meanings in advertisements, thus providing consumers with a better opportunity to compare fees for equivalent services.

   (1)  Examination. A study of the structures of the oral cavity, including the recording of the condition of the structures and the appropriate history. At a minimum, the study shall include the charting of caries; the notation of periodontal disease, occlusal discrepancies, and oral lesions; and a written diagnosis. If a dentist intends to render services in addition to the examination and to charge a separate fee for the additional services, the dentist shall disclose this separate fee to the patient before rendering the additional services.

   (2)  Treatment planning. A written statement of treatment recommendations following an examination and diagnosis. This statement shall include an itemized treatment recommendation and an itemized fee statement.

   (3)  Radiographs. X-rays of the hard and soft oral structures to be used as an aid to diagnosis.

   (4)  Oral prophylaxis. Scaling and polishing of teeth by a licensed dentist or dental hygienist.

   (5)  Restorative dentistry. Procedures involving restoration of tooth structure. The advertisement shall indicate type of restoration and materials to be used.

   (6)  Endodontics. Treatment of the dental pulp, its replacement with suitable material and associated surgery, if indicated.

   (7)  Orthodontics. Prevention and treatment of irregular dentition.

   (8)  Periodontics. Treatment of diseases of the hard and soft tissue surrounding and supporting the oral dentition, including curettage, root planing, surgery, splinting, equilibration and hygiene control procedures.

   (9)  Prosthodontics. Restoration and replacement of teeth and other oral structures by artificial devices, including:

     (i)   Fixed prosthetics. Crowns and bridges. The advertisement shall indicate the type of prosthesis and materials to be used.

     (ii)   Removable prosthetics. Partial and full dentures. The advertisement shall indicate type of prosthesis and materials to be used.

   (10)  Surgery. Surgical treatment of hard or soft tissues, extractions, and treatment of oral pathology, injuries, pain, dysfunction, deformities or other conditions of the oral cavity and its surrounding structures.

   The provisions of this §  33.203 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 Dental procedures shall be assigned to a competent person who the dentist deems appropriate as defined by and consistent with the act.

 (a)  Scope of professional practice. A dental hygienist may offer to perform or perform services that involve:

   (1)  Placement of antimicrobial cord.

   (2)  Periodontal probing, scaling, root planing, polishing or another procedure required to remove calculus deposits, accretions, excess or flash restorative materials and stains from the exposed surfaces of the teeth and beneath the free margin of the gingiva to the base of the junctional epithelium.

   (3)  Evaluation of the patient to collect data to identify dental hygiene care needs.

   (4)  The application of fluorides and other recognized topical agents for the prevention of oral diseases.

   (5)  Conditioning of teeth for and application of sealants.

   (6)  Taking of impressions of the teeth for athletic appliances.

 (b)  Prohibition against independent practice. A dental hygienist is prohibited from establishing or maintaining an office or other workplace for the provision of dental hygiene services separate or independent from the office or other workplace in which the supervision of a dentist is provided.

 (c)  Practice sites. A dental hygienist may engage in professional practice at the following sites under the supervision of a dentist as required in subsection (d):

   (1)  In dental facilities.

   (2)  In public or private institutions such as schools, hospitals, public health care agencies, nursing homes, mobile health units and homes for juveniles, the elderly and the handicapped.

   (3)  In institutions under the jurisdiction of Federal, State or local health agencies.

 (d)  Supervision.

   (1)  In subsection (c)(1) practice sites, the following apply:

     (i)   A dental hygienist may provide the professional service identified in subsection (a)(1) to patients in any ASA Class under the direct supervision of a dentist.

     (ii)   A dental hygienist may provide the professional services identified in subsection (a)(2) to ASA Class I patients under the general supervision of a dentist.

     (iii)   A dental hygienist may provide the professional services identified in subsection (a)(2) to ASA Class II—ASA Class V patients under the direct supervision of a dentist.

     (iv)   A dental hygienist may provide the professional services identified in subsection (a)(3)—(6) to patients in any ASA Class under the general supervision of a dentist.

   (2)  In subsection (c)(2) and (3) practice sites, a dental hygienist shall provide professional services under the general supervision of a dentist. For the purposes of this paragraph, general supervision is defined as supervision by a dentist who authorizes and takes full professional responsibility for the provision of the services. A single authorization may, when appropriate, apply to one or more classes or categories of students/patients.

   (3)  For professional services not identified in subsection (a)(1)—(6) or §  33.302 (relating to auxiliary personnel performing radiologic procedures), the dentist shall compare the listed services and the supervision required with the unlisted service and utilize the appropriate supervision. Supervision for noncomparable services shall be determined by the Board on a modality basis.

   (4)  Notwithstanding the supervision requirements in this subsection, a dental hygienist may provide oral health education and perform preliminary dental screenings in any setting without the supervision of a dentist.

   The provisions of this §  33.205 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

   Ripeness

   Petition for review of these regulations was dismissed as the association of dental hygienists’ allegations of direct and immediate harm did not establish the justiciability of a pre-enforcement challenge to this regulation. The association’s allegations of change in their work schedule, reduced availability of dental hygiene services, reduced income, possible unemployment and the uncertainty of the ongoing day-to-day operations of dental hygiene care are merely anticipatory, speculative and too remote to support a claim of direct and immediate harm. Pennsylvania Dental Hygienists’ Association v. State Board of Dentistry, 671 A.2d 1130 (Pa. Cmwlth. 1996).

 (a)  Scope of professional practice.

   (1)  An expanded function dental assistant may offer to perform or perform the following services:

     (i)   Placing and removing rubber dams.

     (ii)   Placing and removing matrices.

     (iii)   Placing and removing wedges.

     (iv)   Applying cavity liners and bases.

     (v)   Placing and condensing amalgam restorations.

     (vi)   Carving and contouring amalgam restorations.

     (vii)   Placing and finishing composite resin restorations and/or sealant material or both.

   (2)  Each of the professional services identified in paragraph (1) shall be performed under the direct supervision of a dentist.

 (b)  Prohibitions. An expanded function dental assistant may not:

   (1)  Examine, diagnose or plan treatment.

   (2)  Cut hard or soft tissue.

   (3)  Prescribe drugs, medicaments or lab authorizations.

   (4)  Approve the final occlusion.

   (5)  Perform pulp capping, pulpotomy and other endodontic procedures.

   (6)  Perform final placement/cementation of fixed and removable prosthetic appliances.

   (7)  Administer local anesthesia, parenteral or inhalational sedation, nitrous oxide analgesia or general anesthesia.

   (8)  Take impressions other than for study models or diagnostic casts.

 (c)  Supervision. Expanded function dental assistants shall perform under the direct supervision of a dentist. Direct supervision means that a dentist is in the dental office or treatment facility, personally diagnoses the condition to be treated, personally authorizes the procedure and remains in the dental office or treatment facility while the procedure is being performed by the expanded function dental assistant, and, before dismissal of the patient, evaluates the work performed by the expanded function dental assistant.

   The provisions of this §  33.205a amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 (a)  The name, address, telephone number and dental license number of the prescribing dentist shall appear on prescriptions for drugs, services or supplies.

 (b)  Noncompliance with subsection (a) 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)).

 (a)  When prescribing, administering or dispensing controlled substances as defined in section 4 of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-104), a dentist shall comply with, or cause compliance with, the following minimum standards:

   (1)  Scope of authority. A dentist may prescribe, administer or dispense a controlled substance only:

     (i)   In good faith in the course of the dentist’s professional practice.

     (ii)   Within the scope of the dentist-patient relationship.

     (iii)   In accordance with treatment principles accepted by a responsible segment of the profession.

   (2)  Dental examination and medical history. A dental examination shall be conducted and a medical history shall be taken before a dentist initially prescribes, administers or dispenses a controlled substance to a patient. The examination and medical history shall be complete enough to justify the prescription, administration or dispensation of the controlled substance. The examination shall focus on the patient’s dental problems, and the resulting diagnosis shall relate to the patient’s specific complaint. The patient’s dental record shall contain written evidence of the examination and medical history.

   (3)  Records.

     (i)   On each occasion when a controlled substance is prescribed, administered or dispensed to a patient, an entry shall be made in the patient’s dental record containing the following information:

       (A)   The name, quantity and strength of the controlled substance.

       (B)   The directions for use.

       (C)   The date of issuance.

       (D)   The condition for which the controlled substance was issued.

     (ii)   For the purpose of this subsection, health care facility records will be considered part of the patient’s dental record. A patient’s dental record that contains entries pertaining to the issuance of controlled substances shall be retained by the dentist for a minimum of 5 years following the date of the last entry of any kind in the record.

   (4)  Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate short-term prescription may be telephoned to a pharmacist. An emergency prescription for a Schedule II controlled substance shall be covered by a written prescription delivered to the dispensing pharmacist within 72 hours. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history as required by paragraph (2).

   (5)  Exception. This subsection, except for paragraph (1), does not apply when a controlled substance is prescribed, administered or dispensed to a patient in a health care facility regulated by the Department of Health or by the Department of Public Welfare.

 (b)  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)).

 (c)  This section does not restrict or limit the applicability of The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § §  780-101—780-144) or of another statute or regulation and does not relieve a dentist from complying with more stringent standards that may be imposed by another regulation or statute.

   The provisions of this §  33.207 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 (a)  When prescribing, administering or dispensing medications not included under §  33.207 (relating to prescribing, administering and dispensing controlled substances), dentists shall comply with, or cause compliance with, the following minimum standards:

   (1)  Scope of authority. A dentist may prescribe, administer or dispense medication only:

     (i)   In good faith in the course of the dentist’s professional practice.

     (ii)   Within the scope of the dentist-patient relationship.

     (iii)   In accordance with treatment principles accepted by a responsible segment of the profession.

   (2)  Dental examination and medical history. A dental examination shall be conducted and a medical history shall be taken before a dentist initially prescribes, administers or dispenses medication to a patient. The examination and medical history shall be complete enough to justify the prescription, administration or dispensation of the medication. The examination shall focus on the patient’s dental problems, and the resulting diagnosis shall relate to the patient’s specific complaint. The patient’s dental record shall contain written evidence of the examination and medical history.

   (3)  Records. On each occasion when medication is prescribed, administered or dispensed to a patient, an entry shall be made in the patient’s dental record containing the following information:

     (i)   The name, quantity and strength of the medication.

     (ii)   The directions for use.

     (iii)   The date of issuance.

     (iv)   The condition for which the medication was issued.

   (4)  Emergency prescriptions. If an emergency requires the issuance of a prescription, an appropriate short-term prescription may be telephoned to a pharmacist. A dentist may not order a renewal or a refill of an emergency prescription unless the order is in writing and the dentist has given the patient a dental examination and has taken a medical history as required by paragraph (2).

 (b)  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)).

   The provisions of this §  33.208 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492.

 (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)).

   The provisions of this §  33.209 amended under sections 3(c) and 11.2(a) of the Dental Law (63 P. S. § §  122(o) and 130c(a)).

   The provisions of this §  33.209 adopted June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 12, 2000, effective May 13, 2000, 30 Pa.B. 2359; amended May 13, 2005, effective May 14, 2005, 35 Pa.B. 2880. Immediately preceding text appears at serial pages (266034) to (266036).

   Patient’s Complaint

   The State Board of Dentistry’s findings that the dentist failed to properly record the parents’ complaint was supported by substantial evidence, where, based on the expert testimony, the Board found that the dentist should have recorded the parents’ complaint that their son had black spots on his teeth or recorded ‘‘no complaints’’ on the child’s record, and where the Board stated that while the dentist recorded the child’s cavities, such an activity constituted a diagnosis, which is a separate recording requirement. Watkins v. State Board of Dentistry, 740 A.2d 760 (Pa. Cmwlth. 1999).

 Dentists who administer or dispense drugs shall comply with the following standards:

   (1)  Each drug storage area shall be maintained in a clean and orderly condition.

     (i)   The storage area shall be dry, well ventilated and well lighted. Provision shall be made for adequate dust, humidity and temperature controls to ensure drug stability.

     (ii)   The storage area shall contain only drugs and related supplies and equipment which are necessary for the administration and dispensing of drugs to the dentist’s own patients.

     (iii)   Drugs in the storage area shall be accurately labeled. Until a drug is administered or dispensed to a dental patient, it shall be kept in the manufacturer’s original container showing the manufacturer’s lot number and the expiration date.

     (iv)   Drugs in the storage area shall be free from adulteration. Appropriate procedures shall be established to minimize the hazards of cross contamination.

     (v)   Outdated or deteriorated drugs shall be identified as such and shall be segregated in the storage area pending their return to the manufacturer or their appropriate disposal. The dentist shall maintain records reflecting the final disposition of these products.

   (2)  Controlled substances shall be stored in a substantially constructed, locked container such as a cabinet or safe. Access to the locked container where controlled substances are kept in order to clean, replenish supplies or perform other necessary functions shall be allowed only when a dentist is present and supervising.

   (3)  The dentist shall provide for the safe, secure and sanitary disposal of drug-containing refuse.

   (4)  This section prescribes minimum standards for the storage of drugs in dental offices. It does not relieve a dentist from complying with more stringent standards that may be imposed by another regulation or by statute.

   (5)  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)).

 (a)  Dentists. Unprofessional conduct, as defined in section 4.1(a)(8) of the act (63 P. S. §  123.1(a)(8)), includes the following conduct by a dentist:

   (1)  Knowingly or negligently employing as a dentist, dental hygienist or expanded function dental assistant a person whose license or certificate is not current or has been suspended or revoked.

   (2)  Failing to carry out supervisory responsibility with regard to auxiliary personnel or dental residents/interns.

   (3)  Delegating to a person duties that the dentist knows, or has reason to know, the person is not competent to perform or not authorized to perform.

   (4)  Withdrawing dental services after a dentist-patient relationship has been established so that the patient is unable to obtain necessary dental care in a timely manner.

   (5)  Physically, sexually or verbally abusing a patient.

   (6)  Unnecessarily exposing a patient to ionizing radiation.

   (7)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control or to ensure that auxiliary personnel and other supervisees follow these Federal guidelines.

   (8)  Failing to provide necessary dental care to a patent in a timely manner or to apprise the patient of the need for the care.

   (9)  Failing to make available to a patient, within 30 days of a request, information sufficient to enable the patient to complete an insurance form.

 (b)  Dental hygienists. Unprofessional conduct, as defined in section 4.1(a)(8) of the act includes the following conduct by a dental hygienist:

   (1)  Practicing as a dental hygienist without the supervision of a dentist.

   (2)  Performing a service that the dental hygienist knows, or has reason to know, the hygienist is not competent to perform or not authorized to perform.

   (3)  Physically, sexually or verbally abusing a patient.

   (4)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control.

   (5)  Unnecessarily exposing a patient to ionizing radiation.

 (c)  Expanded function dental assistants. Unprofessional conduct, as defined in section 4.1(a)(8) of the act includes the following conduct by an expanded function dental assistant:

   (1)  Practicing as an expanded function dental assistant without the direct supervision of a dentist.

   (2)  Performing a service that the expanded function dental assistant is not competent or not authorized to perform.

   (3)  Physically, sexually or verbally abusing a patient.

   (4)  Failing to follow current infection-control recommendations issued by the Federal Centers for Disease Control.

   (5)  Providing ionizing radiation in violation of §  33.302 (relating to auxiliary personnel performing radiologic procedures).

   The provisions of this §  33.211 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

 As used in section 4.1(a)(2) of the act (63 P. S. §  123.1(a)(2)), the phrase ‘‘misleading, deceptive, untrue or fraudulent representations’’ includes the following conduct by dentists, dental hygienists and expanded function dental assistants:

   (1)  Misrepresenting or concealing a material fact in obtaining, renewing or seeking reinstatement of a license or certificate.

   (2)  Misrepresenting or concealing a material fact in obtaining payment for dental services.

   (3)  Writing a prescription for a controlled substance or other medication in the name of a person other than for whom the controlled substance or other medication is intended under § §  33.207 and 33.208 (relating to prescribing, administering and dispensing controlled substances; and prescribing, administering and dispensing medications).

   (4)  Falsifying a patient’s record regarding treatment or the issuance of a controlled substance or other medication.

   The provisions of this §  33.212 amended under sections 2—5.1, 10—11.5 and 11.7 of the Dental Law (63 P. S. § §  121—124.1, 129—129.1, 130, 130e and 130h).

   The provisions of this §  33.212 adopted January 18, 1965; amended September 12, 1975, effective September 13, 1975, 5 Pa.B. 2397; reserved April 28, 1989, effective April 29, 1989, 19 Pa.B. 1840; amended June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended May 12, 2000, effective May 13, 2000, 30 Pa.B. 2359. Immediately preceding text appears at serial page (223045).

 (a)  Background. The safety of dental amalgams, specifically, whether the mercury in amalgams causes or contributes to a variety of health problems, has become a recurring issue in dentistry. The Board has neither the resources nor the mandate to make or endorse scientific findings on this issue. It is aware, however, of no conclusive evidence that the removal of amalgams will cure or ameliorate disorders other than those associated with confirmed allergic reactions to mercury. Nonetheless, nonallergic patients may request replacement of amalgam restorations in the belief, or merely the hope, that a medical condition will thereby disappear or improve. Dentists receiving these requests must make ethical and professional decisions compatible with the best interests of their patients.

 (b)  Purpose. Section 4.1(a)(8) and (9) of the act (63 P. S. §  123.1(a)(8) and (9)) authorizes the Board to take disciplinary action against licensees who engage in unprofessional conduct or commit acts of negligence, incompetence or malpractice. The replacement of amalgams may implicate both provisions by, for example, generating complaints of unnecessary or even harmful treatment. The Board therefore provides the following guidelines to assist its licensees in conforming their behavior to the requirements of the act. In a disciplinary action brought against a dentist for treatment associated with replacing amalgams, the Board will consider whether these guidelines were followed.

 (c)  Guidelines.

   (1)  The Board recommends that, before replacing amalgams in a nonallergic patient, the dentist:

     (i)   Explain to the patient the current status of research on the safety of dental amalgams.

     (ii)   Provide the patient with information on contraindications and costs associated with removal/replacement of amalgam restorations.

     (iii)   Advise a patient relying on third-party payment to ascertain whether the insurer will cover removal/replacement procedures.

     (iv)   Encourage a patient seeking amelioration of a medical condition to consult with a physician and, as appropriate, secure from the physician documentation of recommendations made to the patient.

     (v)   Memorialize in writing the disclosures made to the patient and the patient’s informed consent.

   (2)  The Board recognizes the right and duty of dentists to refuse to replace amalgam restorations when, in their professional judgment, this procedure would not be in the best interests of the patient.

 (a)  Purpose. This section provides guidelines for compliance with the act of May 26, 1988 (P. L. 403, No. 66) (35 P. S. § §  449.21—449.23), which requires practitioners of the healing arts, before referring a patient to a facility or entity engaged in providing health-related services, tests, pharmaceuticals, appliances or devices, to disclose to the patient any financial or ownership interest of the practitioner in the facility or entity.

 (b)  Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise:

   Appliances or devices—The term includes therapeutic equipment, instruments and prosthetic appliances.

   Disclose to the patient—The practitioner of the healing arts makes known to the patient at the time a referral is made that the practitioner has a financial or ownership interest in the facility or entity to which the patient is referred. The practitioner shall also inform the patient of the patient’s freedom to choose an alternate provider.

   Facility or entity—The term includes another practitioner of the healing arts, licensed health care practitioner, partnership, association, group practice, business corporation and professional corporation not on the premises of the practitioner.

   Financial interest of the practitioner or ownership by the practitioner in the facility or entity—A financial or ownership interest to any extent or degree, including interests held by the practitioner, the practitioner’s spouse or the practitioner’s minor children.

   Health-related services—The term includes radiologic services, physical therapy, counseling and laboratory services.

   Pharmaceutical—Pertaining to a drug or pharmacy.

   Practitioner of the healing arts—A dentist or dental hygienist.

   Referral—The act of prescribing, ordering, directing, redirecting or recommending to a patient a specific facility or entity which provides a health-related service, test, pharmaceutical, appliance or device, either by means of prescription, recommended course of treatment, or direction concerning diagnostic or therapeutic treatment or services.

   Test—The term includes a test necessary for dental diagnosis or treatment.

 (c) Use of patient disclosure forms.

   (1)  It is the practitioner’s responsibility to disclose to the patient a financial or ownership interest when making a referral covered by the act. Meaningful disclosure shall be given to each patient at the time a referral is made. The disclosure may be made orally or in writing. In either event, the Board recommends that the disclosure be memorialized, dated and signed at the time of referral by the practitioner and the patient, and that the practitioner maintain written evidence of the disclosure. If the practitioner delegates the disclosure to another person in the practitioner’s office, the Board recommends that the disclosure be memorialized, dated and signed by the person making the disclosure and the patient.

   (2)  The memorialization of the disclosure shall be substantially in the following form:

   I ACKNOWLEDGE THAT I HAVE BEEN ADVISED BY MY DENTIST/DENTAL HYGIENIST THAT HE/SHE HAS A FINANCIAL OR OWNERSHIP INTEREST IN THE FACILITY OR ENTITY TO WHICH HE/SHE HAS REFERRED ME, AND THAT HE/SHE HAS ADVISED ME THAT I AM FREE TO CHOOSE ANOTHER FACILITY OR ENTITY TO PROVIDE THE SERVICE, DRUG, DEVICE OR EQUIPMENT.

   (3)  In an enforcement proceeding before the Board, the memorialization referred to in paragraphs (1) and (2) shall constitute presumptive evidence that the practitioner made the required disclosure. The disclosure to the patient is not, however, the act of the patient signing the form but is, rather, the act of the practitioner disclosing to the patient the practitioner’s financial or ownership interest and advising the patient of the patient’s freedom of choice.

 (d)  Guidelines for disclosure. With regard to patients who are minors, unconscious, of unsound mind or otherwise incompetent to understand their freedom of choice in selection of a facility or entity, disclosure shall be made to the guardian, spouse or closest adult next of kin. Disclosure of a practitioner’s interest cannot be accomplished unless patients are competent to understand their freedom of choice. A practitioner will not be disciplined for failure to disclose in the event of an emergency which prevents consulting the patient or the patient’s representative.

 (a)  Background and purpose. The use of lasers in experimental and institutional settings has raised questions with regard to using this technology in the dental office. In addressing this issue, the Board has been mindful of its principal mandate: protection of the public. Section 4.1(a)(8) and (9) of the act (63 P. S. §  123.1(a)(8) and (9)) authorizes the Board to take disciplinary action against licensees who engage in unprofessional conduct or who commit acts of negligence, incompetence or malpractice. The use of lasers may implicate both provisions by, for example, generating complaints of incompetent treatment or treatment that fails to conform to acceptable standards of practice. The Board offers the following guidelines to assist its licensees in conforming their behavior to the act. In a disciplinary action brought against a dentist for treatment involving a laser, the Board will consider whether these guidelines were followed.

 (b)  Guidelines. A dentist who uses a laser in private practice shall:

   (1)  Be familiar with and conform to regulations on lasers promulgated by the Food and Drug Administration.

   (2)  Possess clinical competency in the use of lasers. The Board recommends a minimum of 6 hours of instruction given by an accredited institution or by a manufacturer of lasers sponsored by such an institution. The instruction should include hands-on training and should cover all known risks to paitents, staff and the practitioner.

 (a)  General rule. Under 23 Pa.C.S. §  6311 (relating to persons required to report suspected child abuse), Board regulated practitioners who, in the course of their employment, occupation or practice of their profession, come into contact with children shall report or cause a report to be made to the Department of Public Welfare when they have reasonable cause to suspect on the basis of their professional or other training or experience, that a child coming before them in their professional or official capacity is a victim of child abuse.

 (b)  Staff members of public or private agencies, institutions and facilities. Board regulated practitioners who are staff members of a dental or other public or private institution, school, facility or agency, and who, in the course of their employment, occupation or practice of their profession, come into contact with children shall immediately notify the person in charge of the institution, school, facility or agency or the designated agent of the person in charge when they have reasonable cause to suspect on the basis of their professional or other training or experience, that a child coming before them in their professional or official capacity is a victim of child abuse. Upon notification by the Board regulated practitioner, the person in charge or the designated agent shall assume the responsibility and have the legal obligation to report or cause a report to be made in accordance with subsections (a), (c) and (d).

 (c)  Reporting procedure. Reports of suspected child abuse shall be made by telephone and by written report.

   (1)  Oral reports. Oral reports of suspected child abuse shall be made immediately by telephone to ChildLine (800) 932-0313.

   (2)  Written reports. Written reports shall be made within 48 hours after the oral report is made by telephone. Written reports shall be made on forms available from a county children and youth social service agency.

 (d)  Written reports. Written reports shall be made in the manner and on forms prescribed by the Department of Public Welfare. The following information shall be included in the written reports, if available:

   (1)  The names and addresses of the child and the parents or other person responsible for the care of the child, if known.

   (2)  Where the suspected abuse occurred.

   (3)  The age and sex of the subjects of the report.

   (4)  The nature and extent of the suspected child abuse including any evidence of prior abuse to the child or siblings of the child.

   (5)  The name and relationship of the persons responsible for causing the suspected abuse, if known, and any evidence of prior abuse by those persons.

   (6)  Family composition.

   (7)  The source of the report.

   (8)  The person making the report and where that person can be reached.

   (9)  The actions taken by the reporting source, including the taking of photographs and X-rays, removal or keeping of the child or notifying the medical examiner or coroner.

   (10)  Other information which the Department of Public Welfare may require by regulation.

   The provisions of this §  33.250 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

   The provisions of this §  33.250 adopted November 8, 1996, effective November 9, 1996, 26 Pa.B. 5410.

 A Board regulated practitioner may take or cause to be taken photographs of the child who is subject to a report and, if clinically indicated, cause to be performed a radiological examination and other medical tests on the child. Medical summaries or reports of the photographs, X-rays and relevant medical tests taken shall be sent to the county children and youth social service agency at the time the written report is sent or as soon thereafter as possible. The county children and youth social service agency shall have access to actual photographs or duplicates and X-rays and may obtain them or duplicates of them upon request.

   The provisions of this §  33.251 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

   The provisions of this §  33.251 adopted November 8, 1996, effective November 9, 1996, 26 Pa.B. 5410.

 A Board regulated practitioner who has reasonable cause to suspect that a child died as a result of child abuse shall report that suspicion to the coroner of the county where death occurred or, in the case where the child is transported to another county for medical treatment, to the coroner of the county where the injuries were sustained.

   The provisions of this §  33.252 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

   The provisions of this §  33.252 adopted November 8, 1996, effective November 9, 1996, 26 Pa.B. 5410.

 Under 23 Pa.C.S. §  6318 (relating to immunity from liability), a Board regulated practitioner who participates in good faith in the making of a report, cooperating with an investigation, testifying in a proceeding arising out of an instance of suspected child abuse or the taking of photographs shall have immunity from civil and criminal liability that might result by reason of the Board regulated practitioner’s actions. For the purpose of any civil or criminal proceeding, the good faith of the Board regulated practitioner shall be presumed. The Board will uphold the same good faith presumption in any disciplinary proceeding that might result by reason of a Board regulated practitioner’s actions in participating in good faith in the making of a report, cooperating with an investigation, testifying in a proceeding arising out of an instance of suspected child abuse or the taking of photographs.

   The provisions of this §  33.253 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

 To protect children from abuse, the reporting requirements of § §  33.250—33.252 (relating to suspected child abuse—mandated reporting requirements; photographs, medical tests and X-rays of child subject to report; and suspected death as a result of child abuse—mandated reporting requirement) take precedence over any other ethical principle or professional standard that might otherwise apply to a Board regulated practitioner.

   The provisions of this §  33.254 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

 (a)  Disciplinary action. A Board regulated practitioner who willfully fails to comply with the reporting requirements in §  33.250 (relating to suspected child abuse—mandated reporting requirements) will be subject to disciplinary action under section 4.1 of the act (63 P. S. §  123.1).

 (b)  Criminal penalties. Under 23 Pa.C.S. §  6319 (relating to penalties for failure to report), a Board regulated practitioner who is required to report a case of suspected child abuse who willfully fails to do so commits a summary offense for the first violation and a misdemeanor of the third degree for a second or subsequent violation.

   The provisions of this §  33.255 issued under the Child Protective Services Law, 23 Pa.C.S. §  6383(b)(2); and section 3(o) of The Dental Law (63 P. S. §  122(o)).

   The provisions of this §  33.291 adopted September 12, 1975, effective September 13, 1975, 5 Pa.B. 2397; reserved June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492. Immediately preceding text appears at serial page (135712).