243 CMR 2.07
General Provisions Governing the Practice of Medicine
243 CMR 2.07 addresses some issues relating to the practice of medicine by licensees. The
Practice of Medicine is defined in 243 CMR 2.01(4).
(1) Acupuncture. Acupuncture is the practice of medicine and may be performed only by a full
licensee or by an acupuncturist duly licensed and registered in the Commonwealth.
(2) Interpretation of Blood Pressure Measurements. The interpretation of blood pressure
recordings by any method is the practice of medicine.
(3) Standards Pertaining to the Practice of Medicine by Medical Students. A full licensee may
permit a medical student to practice medicine under his or her supervision and subject to the
provisions of M.G.L. c. 112, § 9A. The full licensee's supervision of the medical student's
activities must meet the following requirements:
(a) The full licensee requires that the medical student is identified as a medical student to
each patient and informs patients that they have a right to refuse examination or treatment
by the medical student.
(b) The full licensee ensures that the medical student practices medicine in accordance with
accepted medical standards.
(4) Delegation of Medical Services. There shall be no delegation of medical services to an
individual who is not licensed to perform those services in Massachusetts.
Nothing in 243 CMR 2.07(4) shall be construed as permitting an unauthorized person to
perform activities requiring a license to practice medicine. A full licensee who knowingly
permits, aids or abets the unlawful practice of medicine by an unauthorized person is subject to
discipline pursuant to M.G.L. c. 112, § 5, and 243 CMR 1.05(6).
(5) The Controlled Substances Act. A licensee who violates M.G.L. c. 94C or any regulation
promulgated thereunder also violates 243 CMR 2.00.
(6) Hospital Privileges. (Reserved).
(7) Retirement from the Practice of Medicine (Reserved).
(8) Duty to Report Registration Changes Occurring Outside of the Application or Renewal
Process. Pursuant to 243 CMR 2.04, an applicant or licensee shall notify the Board in writing
when information provided on his or her licensing or renewal application changes during the
application or renewal period. The application or renewal period means the day the initial
application or renewal application is filed to the day the license is issued or renewed. In
addition, a licensee has a duty to report to the Board when the following information provided
to the Board as part of the registration process changes. The licensee shall notify the Board in
writing within 30 days of when the change occurred. The applicant or licensee shall keep the
following information current:
(a) Home and Business Address. A licensee must report to the Board a change of home or
business address within 30 days of the date of the change of address.
(b) Change of Name. An applicant or licensee who changes his or her name shall provide
notice to the Board, within 30 days of the date of the name change, on a form prescribed by
the Board.
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(c) Change in Sex. An applicant or licensee who changes his or her sex shall provide notice
to the Board within 30 days.
(9) Discrimination Against Recipients of Public Assistance Prohibited.
(a) General Rule. A licensee may not discriminate against a person seeking medical
services solely because the person is a recipient of public assistance. 243 CMR 2.07(9)(a)
prohibits a licensee from acting differently toward a recipient of public assistance in any
material manner and requires a licensee to provide medical services of the same quality and
in the same manner to a recipient of public assistance as he or she would to any other person
in similar circumstances who is not a recipient of public assistance.
(b) Limitations on General Rule. A licensee may act in any of the following ways without
violating 243 CMR 2.07(9)(a):
1. The licensee may impose limits upon the availability of his or her services, in other
than medical emergencies, which are based upon nondiscriminatory criteria, e.g.,
professional training and experience;
2. The licensee may impose a limit upon the availability of his or her services, in other
than medical emergencies, that requires a person seeking services to present reasonable
evidence of the person's ability to pay for services prior to his or her rendition;
3. The licensee may withdraw from or decline to participate in the Commonwealth's
medical assistance and medical benefits programs established by M.G.L. c. 118E; or
4. If the licensee is not a Provider within the meaning of M.G.L. c. 118E, § 8, the
licensee may require personal payment of his or her usual charge for services by a person
who is a beneficiary of the Commonwealth's medical assistance and medical benefits
program, after he or she has informed the person, in a manner which the person
understands, of the following:
a. He or she is not a Provider within the meaning of the laws regulating the
Commonwealth's medical care and assistance program;
b. If the person nonetheless requests that the licensee provide medical services, the
licensee will require the person to pay directly his or her usual charge for the
services; and
c. Other physicians who are Providers and would not charge the person directly are
available; and he or she states that, upon request, he or she will attempt to make a
referral to a Provider physician.
(10) Provision of Medical Services in Emergencies.
(a) General Rule. A licensee shall render medical services to a person experiencing a
medical emergency. A medical emergency is a set of circumstances that immediately
threatens a person's life or is likelyto cause serious injuryabsent the provisions of immediate
professional assistance. A licensee shall assume that a person who is referred to him or her
by another licensee for the purpose of securing medical services of an emergency nature is
experiencing a medical emergency.
(b) Limitations on General Rule.
1. A licensee whose professional training or experience is insufficient to enable him or
her to provide medical services of adequate quality to a person experiencing a medical
emergency is excused from complying with the requirement of 243 CMR 2.07(10)(a).
However, he or she must provide reasonable assistance to the person and make a
reasonable attempt to secure competent medical services for the person.
2. A licensee whose professional training or experience, while not insufficient to enable
him or her to provide medical services of adequate quality, is not as appropriate as that
of another licensee or other competent source of assistance known to him or her, may
refer a person experiencinga medical emergencyto such an alternative source of services
if, in the exercise of reasonable professional judgment, doing so would be in the person's
best interests and he or she establishes through verbal communication with the source of
services that the person will be seen promptly.
(c) Refusal to Provide Medical Services. A licensee may not refuse to provide medical
services in the ordinary course of his or her practice to a person experiencing a medical
emergency because the person is unable to pay for the services.
(11) Advertising and Professional Notices by a Full Licensee.
(a) A full licensee engaged in the practice of medicine may advertise for patients by means
which are in the public interest. Advertising that is not in the public interest includes the
following:
1. Advertising that is false, deceptive, or misleading;
2. Advertising that has the effect of intimidating or exerting undue pressure;
3. Advertising that guarantees a cure; or
4. Advertising that makes claims of professional superiority which a licensee cannot
substantiate.
(b) A full licensee may advertise fixed prices, or a stated range of prices, for specified
routine professional services, provided such advertisement clearly states whether additional
charges may be incurred for related services which may be required in individual cases.
(c) A full licensee may advertise in any print or electronic media, including television,
radio, or Internet, provided that he or she maintains a complete, accurate, and reproducible
version of the audio and visual contents of that advertising for a period of three years. The
licensee must furnish a complete copy of this advertising to the Board upon request. The
cost of maintaining and providing this advertising copy shall be borne by the licensee.
(d) A full licensee shall include in an advertisement or professional notice his or her name,
business address and degree (M.D. or D.O.).
(e) A full licensee may not represent that he or she holds a degree from a medical school
other than that degree that appears on his or her application for registration and has been
verified in accordance with the Board's requirements.
(12) Requirement to Respond to Board.
(a) 30-day Period. A licensee shall respond within 30 days to a written communication
from the Board or its designee and shall make available to the Board any relevant and
authorized records with respect to an inquiry or complaint about the licensee's professional
conduct. The 30-day period commences on the date the Board sends the communication by
any method of mailing that provides confirmation of delivery to the licensee's mailing
address of record with the Board.
(b) Ten-day Order to Respond. If the licensee fails to respond to the initial request of the
Board or its Committees within the 30-dayperiod set forth 243 CMR 2.07(12)(a), the Board,
or its Licensing, Data Repository or Complaint Committees, may issue an order that the
licensee respond to its communication within ten days. The Ten-dayOrder to Respond is an
administrative order. A licensee's failure to respond to a written communication from the
Board under 243 CMR 2.07(12)(a) and to a Ten-day Order from a Board or its committees
under 243 CMR 2.07(12)(b) may be considered grounds for a complaint under 243 CMR
1.03(5): Grounds for Complaint.
(13) Medical Records.
(a) Length of Time to Maintain Patient Records. A licensee shall maintain a medical record
for each patient that is complete, timely, legible, and adequate to enable the licensee or any
other health care provider to provide proper diagnosis and treatment. Any records received
from another health care provider involved in the care and treatment of the patient shall be
maintained as part of the patient's medical record. With respect to patient records existing
on or after January 1, 1990 and unless otherwise required by law, a licensee must maintain
a patient's medical records for a minimum period of seven years from the date of the last
patient encounter. However, if the patient is a minor on the date of the last patient encounter,
the licensee must maintain the minor patient's records for a minimum period of either seven
years from the date of the last patient encounter or until the patient reaches 18 years of age,
whichever is the longer retention period. A licensee must maintain a patient's records in a
manner which permits the former patient or a successor physician reasonable access to the
records within the terms of 243 CMR 2.00. 243 CMR 2.00 applies to all licensees including,
but not limited to, those with active, inactive, lapsed, suspended, revoked, resigned or retired
status.
(b) Providing Medical Records. Upon a patient's request, a licensee shall provide the
following in a timely manner, to a patient, other licensee or other specifically authorized
person:
1. The opportunity to inspect that patient's medical record, except in the circumstances
described at 243 CMR 2.07(13)(e);
2. A copy of such record, except in the circumstances described at 243 CMR
2.07(13)(e);
3. A copy of any previously completed report required for third-party reimbursement.
(c) Fees. A licensee may charge a reasonable fee for the expense of providing the material
enumerated in 243 CMR 2.07(13)(b); however, a licensee may not require prior payment of
the charges for the medical services to which such material relates as a condition for making
the records available. Charges for providing copies of medical records must be in
compliance with M.G.L. c. 111, § 70, M.G.L. c. 112, § 12CC and 45 CFR 164.524(c)(4).
Charges for providing copies of X-rays and similar documents not reproducible by ordinary
photocopying may be at the licensee's actual cost.
(d) Medical Record Requested in Relation to a Needs-based Benefit Program. A licensee
shall not charge a fee of any applicant, beneficiary or individual representing said applicant
or beneficiaryif the record is requested for the purpose of supporting a claim or appeal under
any provision of the Social Security Act or any federal or state financial needs-based benefit
program.
Any person for whom no fee shall be charged shall present reasonable
documentation at the time of such record request that the purpose of such request is to
support a claim or appeal under any provision of the Social Security Act or any federal or
state financial needs-based benefit program.
(e) Psychiatric Records. Licensees who devote a substantial portion of their time to the
practice of psychiatry shall abide by the provisions of 243 CMR 2.07(13). Pursuant to
M.G.L. c. 112, § 12CC, if, in the reasonable exercise of his or her professional judgment,
such a licensee determines that providing the entire medical record would adversely affect
the patient's well-being, the licensee shall make a summary of the record available to the
patient. If a patient continues to request the entire record, notwithstanding the licensee's
determination, the licensee shall make the entire record available to the patient's attorney,
with the patient's consent, or the patient's legal representative, or to such other
psychotherapist as designated by the patient.
(f) Medical Records of Deceased Physician. The executor or administrator of a deceased
physician licensed pursuant to M.G.L. c. 112, § 2, shall retain medical records in existence
upon the death of the physician and provide reasonable access to patients' requesting their
medical records. The executor or administrator must maintain a patient's medical records for
a minimum period of seven years from the date of the last patient encounter.
(14) Breast Cancer. (Reserved).
(15) Medicare Payments. When a licensee accepts for treatment a beneficiary of health
insurance under Title XVIII of the Social Security Act (Medicare), the licensee shall not charge
to or collect from such beneficiaryanyamount in excess of the Medicare Physician Fee Schedule
charge for that service as determined by the United States Secretary of Health and Human
Services and as administered by the Centers for Medicare and Medicaid Services.
(16) Mandatory Professional Malpractice Liability Insurance. As a condition of rendering any
direct or indirect patient care in the Commonwealth, a licensee must obtain medical malpractice
insurance as follows, except as provided in 243 CMR 2.07(16)(d):
(a) Professional Malpractice Liability Insurance shall include only insurance or self
insurance coverage provided by an entity which provides certification to the Board, upon
request, or the Division of Insurance, by a Member of the Casualty Actuarial Society, that
funding of the entity is adequate to provide the coverage required under 243 CMR 2.07(16).
(b) The coverage amount shall be at least $100,000 per claim, with a minimum annual
aggregate of not less than $300,000, unless otherwise established by law. Coverage may be
provided on an individual or shared limit basis.
(c) 243 CMR 2.00 shall not preclude anyhospital or other health care facilityfrom requiring
greater coverage amounts as a condition of appointment or granting privileges.
(d) A Health Care Provider, for purposes of 243 CMR 2.07(16) only, shall mean a health
care provider as defined in M.G.L. c. 175, § 193U, and shall not apply to the following
categories of licensees:
1. Licensees who are not engaged in the practice of medicine in the Commonwealth.
2. Licensees whose patient care in the Commonwealth is limited to professional services
rendered at or on behalf of federal, state, county or municipal health care facilities.
3. Licensees holding only limited registrations pursuant to M.G.L. c. 112, § 9, who are
insured through the programs designated on the licensees' certificates of registration.
4. Administrative licensees.
(e) In lieu of obtaining such professional malpractice liability insurance, the licensee may
petition the Board for permission to obtain a suitable bond or other indemnityagainst liability
for professional malpractice, in the amounts specified in 243 CMR 2.07(16)(b).
(f) Coverage required by 243 CMR 2.00 shall be continued until the expiration of any
statute of limitations relevant to the events or occurrences covered. Compliance may be
through occurrence coverage or claims made with appropriate tail coverage.
(17) Reporting Requirements. (Reserved).
(18) Excessive Treatment and Billing of People Involved in Automobile Accidents.
(Reserved).
(19) Self-prescribing and Prescribing for Family Members. A licensee is prohibited from
prescribing controlled substances in Schedules II, III, and IV for his or her own use. Except in
an emergency, a licensee is prohibited from prescribing Schedule II substances to a member of
his or her immediate family, including a spouse (or equivalent), parent, child, sibling,
parent-in-law, son/daughter-in-law, brother/sister-in-law, step-parent, step-child, step-sibling,
or other relative residing in the same residence as the licensee. A licensee who prescribes any
controlled substance to a member of his or her immediate family, as defined herein, shall
maintain a medical record for such person.
(20) Prescribing Anabolic Steroids. A licensee is prohibited from prescribing anabolic steroids
for the purpose of enhancing a patient's athletic ability or performance.
(21) PrescribingAnorectics. A licensee is prohibited from prescribinganycontrolled substance
in Schedule II for its anorectic effect.
(22) Business Organizations and the Practice of Medicine.
(a) A licensee may practice medicine through the following business organizations:
1. A professional corporation pursuant to M.G.L. c. 156A;
2. A nonprofit organization, a nonprofit hospital services corporation organized under
M.G.L. c. 176A, a nonprofit medical services corporation organized under
M.G.L. c. 176B;
3. A limited liability company organized under M.G.L. c. 156C, provided there are no
LLC provisions limiting or eliminating the licensee's liability for intentional tort or
negligence;
4. A partnership (including a registered limited liability partnership) organized under
M.G.L. c. 108A, provided the partnership has no provisions limiting or eliminating the
licensee's liability for intentional torts or negligence; or
5. An organization similar to those organizations described in 243 CMR 2.07(22)(a)1.
through 4. and organized under a comparable law of anyother United States jurisdiction.
(b) Nothing in 243 CMR 2.07(22) shall prohibit a licensee from practicing medicine as an
employee of a licensed health care facility.
(23) Exemption for Reports of Drug or Alcohol Misuse to the Board under M.G.L. c. 112, § 5F.
(a) Requirements for Reporting Exemption to Apply. A health care provider as defined by
M.G.L. c. 111, § 1, who is required to report a physician to the Board pursuant to
M.G.L. c. 112, § 5F, is exempt from filing such a report if all four of the following
conditions are present:
1. Reasonable Basis to Believe Impairment. The health care provider has a reasonable
basis to believe that the physician is or has been impaired by, dependent upon or
misusing alcohol or drugs such that a report could be required under M.G.L. c. 112, § 5F;
2. No Violation of Law or Regulation. The physician has not violated any statute or
regulation, including M.G.L. 94C, and including any Board statute or regulation;
3. No Allegation of Patient Harm or Impairment at the Workplace or While on Call.
The physician's involvement with alcohol or drugs has not involved an allegation of
patient harm or any impairment occurring at the workplace or while the physician is "on
call"; and
4. Confirmation of Compliance with the Treatment Program. The physician is currently
in compliance with a drug or alcohol program, approved under 243 CMR 2.07(23)(b),
and the health care provider obtains direct confirmation from such drug or alcohol
program, within 30 days of acquiring the "reasonable basis to believe" under 243 CMR
2.07(23)(a), that the physician is in compliance with such program. If the health care
provider fails to obtain direct confirmation from such program or if the physician at any
time fails to comply with such program, the exemption to the reporting requirement set
forth in 243 CMR 2.07(23) ceases and the health care provider must report the
impairment to the Board as required by M.G.L. c. 112, § 5F.
(b) Requirements for Drug or Alcohol Program to Qualify for 243 CMR 2.07(23).
1. The drug or alcohol program must be approved by a majority vote of the Board.
Approval may be withdrawn, at any time, for cause, by majority vote of the Board and
with reasonable advance notice to the program of the reasons for the proposed
withdrawal of approval and an opportunity to dispute such reasons. However, nothing
herein shall be construed to provide a right to an adjudicatory hearing pursuant to
M.G.L. c. 30A.
2. The drug or alcohol program shall require as a condition of the physician's
participation that the physician consent, pursuant to 42 CFR 1, subpart A, part 2,
subsection C, to disclosure of relevant information to the Board, under any of the
following conditions:
a. If the physician fails to correct, within a reasonable period of time, a failure to
provide documentation of his or her continuing freedom from unauthorized substance
use;
b. If the physician is known by the program to be in a state of unauthorized
substance use, or if the physician is in a state of unauthorized substance use after
signing his or her contract with the program;
c. If the program has a reasonable basis to believe that the physician, for any reason,
cannot render professional services without undue risk to the public;
d. If the physician revokes consent to disclose information to the Board during the
course of his or her contract with the program; or
e. If the physician terminates his or her contract with the program for any reason
other than his or her successful recovery, in which the program concurs.
3. The drug or alcohol program requires that the physician consent to confirmation to
the reporter, pursuant to federal regulations, that the physician is participating in the
program, to the extent that the reporter needs such confirmation pursuant to 243 CMR
2.07(23)(c).
(24) Standards for Reading and Interpreting Mammography.
(a) Initial Qualification. Pursuant to M.G.L. c. 112, § 5L, a licensee may read and interpret
mammography only if the licensee meets the following criteria:
1. Is licensed to practice under M.G.L. c. 112, § 2; and
2. Has American Board of Radiology (ABR) or American Osteopathy Board of
Radiology(AOBR) certification, or Royal College of Physicians and Surgeons of Canada
(RCPSC) certification; or
3. Has successfully completed and graduated from an accredited radiology residency
within the past 24 months; or
4. Has had at least three months of documented formal training in the interpretation of
mammograms and in topics relating to mammography. The training shall include
instruction in radiation physics, including radiation physics specific to mammography,
radiation effects and radiation protection. The mammographic interpretation component
shall be under the direct supervision of a physician who meets the requirements of
243 CMR 2.07(24)(a).
(b) Experience for Initial Qualification. The licensee has read and interpreted an average
of no less than 480 mammograms in the prior year, and continues to perform mammograms
at this frequency.
(c) CME Requirements for Initial Qualification. If initially qualified before April 28, 1999,
the licensee has successfully completed or taught a minimum of 40 hours postgraduate
Category 1 CME instruction in mammography interpretation; or, if initially qualified after
April 28, 1999, has successfully completed or taught a minimum of 60 hours of Category 1
CME instruction in mammography interpretation; and of the Category 1 CME instruction
hours required in 243 CMR 2.07(24)(c), 15 hours of the total Category 1 CME hours were
acquired within the three years immediately prior to the licensee's qualification date.
(d) Renewal Qualifications. The licensee shall interpret 960 mammographic examinations
over a 24-month period, and shall take at least 15 hours of Category 1 CME in
mammography in a 36-month period while performing the duties of an Interpreting
Physician.
(e) New Mammographic Modalities. Before an Interpreting Physician may independently
interpret mammograms produced by a new mammographic modality, i.e., a mammographic
modality in which the physician has not previously been trained, the Interpreting Physician
shall have at least eight hours of training in the new mammograms.
(f) Interpreting Physician. In addition to the requirements of 243 CMR 2.07, a licensee
acting as an Interpreting Physician shall meet the requirements of the Radiation Control
Board as set forth in 105 CMR 127.014: Requirements of the Interpreting Physician.
(g) Responsible Physician. A licensee acting as a responsible physician, as defined in the
regulations of the Radiation Control Program of the department of public health, at 105 CMR
127.005: Definitions, must:
1. Meet the requirements of 243 CMR 2.07(24)(a)1. through 3.;
2. Actively practice medicine at least ten hours per week;
3. Have read and interpreted 960 mammograms in the prior 24 months;
4. Continues to perform mammograms at this frequency;
5. Has successfullycompleted or taught a minimum of 40 hours postgraduate instruction
in mammography prior to beginning mammography activities; and
6. Completes or teaches 15 hours of Category 1 CME every 36 months while
performing the duties of a Responsible Physician.
(25) Prescribing Hydrocodone-only Extended-release Medication. Prior to prescribing a
hydrocodone-only extended release medication that is not in an abuse deterrent form, a licensee
must:
(a) Thoroughly assess the patient, including an evaluation of the patient's risk factors,
substance abuse history, presenting condition(s), current medication(s), a determination that
other pain management treatments are inadequate, and a check of the patient’s data through
the online Prescription Monitoring Program;
(b) Discuss the risks and benefits of the medication with the patient;
(c) Enter into a Pain Management Treatment Agreement with the patient that shall
appropriately address drug screening, pill counts, safe storage and disposal and other
requirements based on the patient's diagnoses, treatment plan, and risk assessment, unless
a Pain Management Treatment Agreement is not clinically indicated due to the severity of
the patient’s medical condition;
(d) Supply a Letter of Medical Necessity as required by the Board of Registration in
Pharmacy pursuant to 247 CMR 9.04(8)(c); and
(e) Document 243 CMR 2.07(25)(a) through (d) in the patient's medical record.
The purpose of 243 CMR 2.07(25) is to enhance the public health and welfare by promoting
optimum therapeutic outcomes, avoiding patient injury and eliminating medication errors.
Nothing in 243 CMR 2.07(25) shall alter the standard of care a licensee must use when
prescribing any Schedule II, III or IV controlled substance.
(26) Informed Consent. A physician has the obligation to obtain and record a patient's written
informed consent before diagnostic, therapeutic or invasive procedures, medical interventions
or treatments. Informed consent means that the physician has disclosed and explained to the
patient's satisfaction the process used to arrive at the medically reasonable and recommended
procedure, intervention or treatment, based on reliable evidence of the expected benefit and risk
of each alternative, free from any impermissible bias. Written informed consent means that the
patient, who has demonstrated capacity, or the patient's representative, has been given ample
opportunity to ask questions, with all questions having been answered to the patient's or
representative's satisfaction, and with the patient or representative giving consent in writing to
the procedure, intervention or treatment.
(a) Definitions. For purposes of 243 CMR 2.07, and 243 CMR 3.10: Qualified Patient
Care Assessment Program - Specified Requirements in the Practice of Medicine, the terms
listed in 243 CMR 2.07(26) have the following meanings:
Attending Physician/Primary Operator means the physician licensed under M.G.L. c. 112,
§§ 2 through 9B who has been credentialed by the health care facility to independently
perform the patient's procedure, medical intervention or treatment and to supervise physician
trainees or physician extenders. The attending physician/primary operator is responsible for
discussing the risks and benefits of the procedure, intervention or treatment and obtaining
the patient's written informed consent.
Physician means a person licensed to practice medicine under M.G.L. c. 112, §§ 2 through
9B.
Physician Extender means a person who is participating in the patient's procedure, medical
intervention or treatment and who is under the direct supervision of the attending
physician/primary operator. A physician extender may be a resident, a fellow, a physician
assistant, an advanced practice registered nurse or other person authorized by the health care
facility to participate in the procedure, intervention or treatment and who is directly
supervised by the attending physician/primary operator.
(b) Written Policy on Written Informed Consent. Every physician shall have written
policies and procedures designed to address the written informed consent process. At a
minimum, the policies should address:
1. The medical procedures, interventions and treatments for which informed consent is
required and the content of the information provided.
2. Designation of persons responsible for obtaining informed consent from the patient.
3. How the written informed consent will be documented.
4. Designation of appropriate persons, other than the patient, from whom consent may
be obtained, and the circumstances when consent may be obtained from a person other
than the patient.
(c) When Informed Consent Is Necessary. Written consent shall be obtained before all
diagnostic, therapeutic or invasive procedures, medical interventions or treatments where
disclosure of significant medical information, includingrisks involved, would assist a patient
in making an informed decision whether to undergo the proposed procedure, medical
intervention or treatment.
(d) Duty of Attending Physician/Primary Operator. It shall be the responsibility of the
attending physician/primary operator to obtain the written informed consent of the patient,
and to discuss sufficient medical information to enable the patient to decide whether to
undergo the proposed procedure, intervention or treatment. Although the attending
physician/primary operator is responsible for informing the patient, health care facility
personnel may assist in the completion of written informed consent documentation.
(e) Informed Consent Shall Be Clear and Detailed. A patient's written informed consent
shall be documented in writing with sufficient clarityand detail so as to satisfythe reader that
the patient was given and understood the medical information provided. The written
informed consent shall clearly identify the attending physician/primary operator of record.
The attending physician/primary operator shall sign the informed consent prior to the
procedure, intervention or treatment.
(f) Patient's Medical Record Must Reflect Who Will Participate in the Procedure. Prior to
the procedure, the attending physician/primary operator must inform the patient of who will
be participating in the procedure, intervention or treatment, including the names of all
physician extenders who are under the direct supervision of the attending physician/primary
operator. The attending physician/primaryoperator shall note the physician extenders on the
written informed consent form.
(g) Patient's Medical Record Must Reflect Any Absence of Attending Physician/Primary
Operator. The attending physician/primary operator at a medical procedure, intervention or
treatment requiring the patient's written informed consent shall be responsible for including
in the patient's medical record, or having included, written documentation of the attending
physician's presence or absence during the procedure, intervention or treatment. If the
attending physician/primary operator was absent for any part of the procedure, the medical
record shall reflect the time of the absence(s) and who was the attending physician/primary
operator during the absence(s).
(h) A patient is entitled to a copy of the written informed consent.
(27) Infection Prevention and Control.
(a) Whether practicing medicine in a surgical or in an outpatient setting, a physician must
implement and maintain infection control policies and procedures. These policies and
procedures should be tailored to the healthcare setting and to the patient population and
reassessed on a regular basis.
(b) The following are the minimum infection prevention practice areas that apply to all
patient care in any setting. They include:
1. Hand hygiene;
2. Use of Personal Protective Equipment (PPE) (e.g., gloves, gowns masks);
3. Safe injection practices;
4. Safe handling of potentially contaminated equipment or surfaces; and
5. Respiratory hygiene/cough etiquette.