02-313 C.M.R. ch. 12, § I - GENERAL PRACTICE REQUIREMENTS

The following practice responsibilities apply to individuals licensed as indicated below:

A. INFECTION CONTROL

(1) All licensees shall utilize the CDC Guidelines for Infection Control in Dental Health-Care Settings, 2003.

(2) A licensee who is providing general supervision or direct supervision must ensure the supervised individual's training and/or certification is completed to comply with the CDC Guidelines noted in Section I (A)(1).

B. RADIATION PROTECTION; DENTAL RADIOGRAPHS; PATIENT SELECTION

(1) A licensee who is providing dental services utilizing radiological equipment is required to operate and maintain such equipment in compliance with Maine's Radiation Control Program, as provided for in the Radiation Protection Act, 22 M.R.S. §§ 671-690.

(2) A licensee who is authorized to practice dental radiography or use ionizing radiation for diagnostic purposes is required to place on or over a patient's body radiation barriers, such as protective aprons and thyroid shields, prior to exposing that patient to ionizing radiation.

(3) A licensee shall utilize the ADA/FDA publication "Dental Radiographic Examinations: Recommendations for Patient Selection and Limiting Radiation Exposure" (as revised in 2012) when selecting patients for dental radiographic examinations and utilizing ionizing radiation.

C. LOCAL, STATE, AND FEDERAL HEALTH AND SAFETY REGULATIONS

(1) All licensees shall comply with the following:

(a) Premises shall be kept clean, orderly and free of accumulated rubbish and similar substances;

(b) Premises shall be kept free of all insects and vermin by utilizing proper control and eradication methods;

(c) Piped water supply shall conform with local, state and federal regulations. Use of other water sources shall comply with the CDC Guidelines for Infection Control in Dental Health-Care Settings, 2003;

(d) All structures shall be in compliance with local and state building codes;

(e) Sanitary conditions shall be maintained at all times for patients and employees, including immediately available toilet facilities. See 29 C.F.R. § 1910.141(c); and

(f) Operations shall be in compliance with OSHA Standards applicable to dental practices related to bloodborne pathogens, hazard communication, ionizing radiation, and exit routes and emergency planning. See 29 C.F.R. §§ 1910.35-1910.39, 1910.1030, 1910.1096, 1910.1200.

D. EMERGENCY PROTOCOL

(1) All licensees shall comply with the following:

(a) Adopt and follow a written protocol for managing medical or dental emergencies;

(b) Maintain a current emergency drug kit appropriate to scope of practice;

(c) Maintain communication equipment that ensures rapid access to emergency responders and others as necessary;

(d) Provide training, if responsible for hiring and/or supervising staff, to ensure that staff are trained upon employment/supervision, and at least annually thereafter, to implement the emergency protocols; and

(e) Maintain accessibility to an automated external defibrillator device.

E. DENTAL ADVERSE OCCURENCE REPORT

(1) All licensees shall report the following adverse conditions to the Board:

(a) Death of a patient within 48 hours after the administration of a dental practice procedure. Such reporting shall be made within 72 hours of the death.

(b) Activation of an emergency response of a patient or emergent transport of a patient to another facility. Such reporting shall be made within 72 hours of obtaining knowledge of the emergency.

(2) Information to be included in the adverse report:

(a) Date and time of occurrence;

(b) Name of patient;

(c) Dental practice procedure involved, if any;

(d) Type and dosage of nitrous oxide analgesia, local anesthesia, sedation, and/or general anesthesia used in the procedure; and

(e) Description of the occurrence.

(3) In the event the licensee does not have knowledge or cannot reasonably be expected to have knowledge, but subsequently obtains actual knowledge of an adverse occurrence, then such licensee shall report to the Board the earlier of 72 hours after obtaining knowledge of a patient death, or 30 days after obtaining knowledge of the permanent organic brain dysfunction or hospitalization of a patient related to a dental procedure.

F. CONTROLLED SUBSTANCES; INVENTORY CONTROL

(1) Dentists who are authorized to dispense, administer, and prescribe any controlled substances shall do so in accordance with 32 M.R.S. §18308, Board Rules, Chapter 21, and the provisions of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §§ 801-971.

(2) Dentists authorized to prescribe, administer and dispense controlled substances shall adopt protocols to maintain inventories and records of controlled substances in accordance with state and federal laws and regulations. Protocols shall be reviewed at least annually and updated as needed. Licensees who hold permits issued by the United States Department of Justice, Drug Enforcement Administration shall adhere to the practitioner requirements as outlined in the "Practitioner's Manual - An Informational Outline of the Controlled Substances Act" (2006 Edition), published by the Drug Enforcement Administration, Office of Diversion Control.

G. PATIENT RECORDS: Commensurate with a licensee's scope of practice, patient records shall include, but are not limited to, dental charts, photographs, patient histories, examination and test results, diagnoses, treatment plans, progress notes, anesthesia charts, prescriptions, radiographs, patient consents, and billing records.

(1) Confidentiality of Patient Records. All patient records shall be maintained in a manner that ensures confidentiality and access for patients and authorized practitioners who may wish to obtain a copy of patient records as required by the state and federal requirements. See 22 M.R.S. §1711-C; 45 C.F.R. §§ 164.500164.534 (privacy rule of the Health Insurance Portability and Accountability Act, or "HIPAA").

(2) Record Retention Requirement. A dentist, denturist, dental hygienist who is practicing with an independent practice dental hygiene authority, public health dental hygiene authority, or dental therapy authority (including a provisional authority) shall maintain a patient's original dental record and original radiographs for a minimum of seven (7) years from the date of the last patient treatment.

Licensees who do not have legal authority or ownership over patient records in the delivery of their services shall, at a minimum, maintain access to such records to comply with this subsection.

(3) Availability of Dental Records

(a) The licensee shall provide upon written request by a patient or another specifically authorized person, a copy of the patient's dental record. A copy of the patient record, including radiographs, shall be provided within a reasonable amount of time not to exceed 21 days from the receipt of the request. The licensee may charge a reasonable fee for the expense of providing a patient's record, not to exceed the cost of either labor and/or materials incurred in the copying of the patient record and radiographs. The licensee shall not require payment for services rendered as a condition of providing a copy of the patient record.

(b) Electronic patient records shall be unalterable and producible in paper form upon request.

H. CONTENT OF PATIENT RECORDS: All licensees shall comply as set forth below:

(1) The patient record shall be a complete record of all patient contact, including, but not limited to, a general description of the patient's medical and dental history and status at the time of examination, diagnoses, patient education, treatment plan, referral for specialty treatment, medications administered and prescribed, pre- and post-treatment instructions, and information conveyed to the patient.

(2) Patient records shall be legible and clear in meaning to a subsequent examining or treating dentist, the patient, dental auxiliaries or other authorized persons.

(3) At a minimum, a patient's record shall include:

(a) Patient Information

i. Name, address and date of birth of the patient;

ii. If the patient is not of the age of majority, the name of the parent or legal representative; and

iii. Patient's telephone numbers(s) and electronic mail addresses, except if the patient declines to provide this information.

(b) Medical and Dental History Form. The patient's medical history and dental history shall include, but not be limited to:

i. A review of past and present illnesses, diseases and disabilities;

ii. Systemic disease(s);

iii. Current prescription and non-prescription medications as well as any known drug allergies;

iv. Documentation of consultation with the patient's medical physician(s) as appropriate;

v. Date of the patient's last dental visit and frequency of dental visits; and

vi. At each patient visit, the licensee shall inquire and document in the patient record any changes in the patient's medical history, including but not limited to, changes in medications.

(c) Record of Examination. Each patient record shall include documentation of the results of a comprehensive examination of the following areas:

i. Head and neck;

ii. Radiographic images as necessary and appropriate to facilitate a comprehensive diagnosis of the patient. Radiographs shall be clearly identified with the patient name, and date the radiographic exposure was taken;

iii. Intra-oral and extra-oral soft tissue examination, including charting of existing restorations and current status of patient's hard and soft tissue;

iv. Comprehensive periodontal screening;

v. Oral cancer screening;

vi. Examination of the teeth;

vii. Duration of edentulousness, and any previous or existing removable prosthesis;

viii. Results of any other examination performed as necessary and appropriate to facilitate comprehensive diagnoses of the patient's dental status;

ix. Findings which are within or outside of normal limits; and

x. Baseline blood pressure at initial consultation visit, and as clinically necessary thereafter.

(d) Diagnoses. The patient record shall include written diagnoses of the patient's current dental status based on the evaluation of the patient's medical and dental history, examination, and radiographic findings.

(e) Treatment Plan. The patient record shall include a written treatment plan describing in detail the proposed treatment. The proposed treatment plan, including alternatives to treatment, and information regarding estimated fees must be reviewed with the patient prior to the commencement of treatment. The treatment plan shall also include referrals to other providers as necessary. If there is no treatment plan this must be explained and documented in the patient record.

(f) Informed Consent. There are two categories of informed consent: implied consent and express consent.

i. Implied Consent. Implied consent is a presumed type of permission based on the patient's conduct and it applies primarily to non-invasive procedures such as consultations, examinations, and diagnoses.

ii. Express Consent. Express consent is a more formal type of permission founded on words, either oral or written, and it applies to more invasive procedures. Written informed consent is an express consent which includes the signature of (at least) both the licensee and the patient (or the patient's legal guardian).

(g) Progress Notes. The patient record shall include written documentation of the treatment provided by the dentist and/or dental auxiliary, including but not limited to:

i. Administration of medicines and medicaments including the type, amount, and route of administration;

ii. A statement of services provided including patient reaction, if any, during the treatment visit, procedures performed, and diagnoses;

iii. A description of the pre- and post-treatment instructions including, if applicable, plans for subsequent treatment;

iv. Documentation of any referral for specialty treatment, including the name of the specialist the patient is referred to; and

v. A dated written or electronic signature by the dentist or dental auxiliary who treated the patient.

(h) Patient Financial Payment/Record. The patient's financial record shall include, but not be limited to, the name of the patient's dental insurer, documentation of fees for treatment and payment schedule, and claims submitted to third parties.

I. PATIENT DISMISSAL: Dentists, denturists, dental hygienists who are practicing with an independent practice dental hygiene authority, a public health hygiene authority, or a dental therapist authority (including provisional) shall comply as set forth below:

(1) A written notice of dismissal shall be sent to the patient and/or patient's guardian by certified return/receipt mail. The dismissal is effective as of the date of the letter. However, the licensee must offer the patient a 30-day emergency care period from the date of the dismissal notice. The date identifying the end of the 30-day emergency care period must also be clearly indicated in the dismissal notice; and

(2) The licensee shall offer and supply copies of the dismissed patient's dental records upon request by the dismissed patient and/or patient's guardian, regardless of the patient meeting his/her financial obligation. Offering to supply the patient's records should be clearly noted, as well, within the termination letter. Supplying records may not be contingent on receipt of payment.

J. PRACTICE SALE AND CLOSURE NOTIFICATIONS; WAIVER

(1) Licensees who either sell or close a practice shall provide to the Board in writing within 10 days from the date of sale or closure the following documentation:

(a) Practice sale. If the practice sale includes the transfer of patient records, then contact information including the name, address, phone number of the new owner and/or individual responsible for the patient records shall be submitted to the Board.

(b) Practice closure. If the practice closure includes the transfer of patient records, then contact information including the name, address, phone number of the individual responsible for the patient records shall be submitted to the Board.

(c) Practice closure. Submit documentation of the communication tools used such as newspaper ads, social media accounts, email notifications, or letters notifying patients at least 30 days in advance of the closure. The notification shall list specific times for patients to obtain copies of their records.

(d) Board waiver. The Board retains the authority to waive the requirements where immediate sale and/or closure is a result of sudden illness, incapacity, death, or other cause as determined by the Board.

Notes

02-313 C.M.R. ch. 12, § I