243 Mass. Reg. 2.07 : BOARD OF REGISTRATION IN MEDICINE — Licensing and the practice of medicine — THE PRACTICE OF MEDICINE — 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.

(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 likely to cause serious injury absent 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 experiencing a medical emergency to 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-day period 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-day Order 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 beneficiary if 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 beneficiary any amount 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 any hospital or other health care facility from 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 indemnity against 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) Prescribing Anorectics. A licensee is prohibited from prescribing any controlled 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 any other 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 successfully completed 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, including risks 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 clarity and detail so as to satisfy the 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/primary operator 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: