North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 13 - NC MEDICAL CARE COMMISSION › Subchapter B - LICENSING OF HOSPITALS › Section .3300 - PATIENT'S BILL OF RIGHTS › Section 13B .3302 - MINIMUM PROVISIONS OF PATIENT'S BILL OF RIGHTS

Current through Register Vol. 39, No. 2, July 15, 2024
This Rule does not apply to patients in licensed nursing
					 facility beds since these individuals are granted rights pursuant to
					 G.S.
					 131E-117. A patient in a hospital facility
					 subject to this Rule has the following rights pursuant to
					 42 CFR
					 482.13, which is hereby incorporated by
					 reference including subsequent amendments and editions. This regulation can be
					 accessed at
https://www.ecfr.gov/cgi-bin/text-idx?SID=e867c7c6cbfeb689406afea7d88e8a80&mc=true&node=pt42.5.482&rgn=div5#se42.5.482_113
at no cost:
(1) A patient has the
				  right to respect, dignity, and comfort.
(2) A patient has the right, upon request, to
				  be given the name of his or her attending physician, the names of all other
				  physicians participating in his or her care, and the names and functions of
				  other health care persons having contact with the patient.
(3) A patient has the right to privacy
				  concerning his or her own medical care program. Case discussion, consultation,
				  examination, and treatment are considered confidential and shall be conducted
				  privately pursuant to 42 CFR
				  482.13(c)(1):
(4) A patient has the right to know what
				  facility rules and regulations apply to his or her conduct as a
				  patient.
(5) A patient has the
				  right to expect emergency procedures to be implemented without delay.
(6) A patient has the right to quality care
				  and professional standards that are maintained and reviewed.
(7) A patient has the right to information in
				  laymen's terms, concerning his or her diagnosis, treatment and prognosis,
				  including information about alternative treatments and possible complications.
				  When it is not possible or medically advisable to give such information to the
				  patient, the information shall be given on his or her behalf to the patient's
				  designee.
(8) Except for
				  emergencies, a physician must obtain informed consent prior to the start of any
				  procedure or treatment.
(9) A
				  patient has the right to be advised when a physician is considering the patient
				  as a part of a medical care research program or donor program. Informed consent
				  shall be obtained prior to participation in such a program. The patient or
				  legally responsible party may refuse to continue in any program that he or she
				  has previously given informed consent. An Institutional Review Board (IRB) may
				  waive or alter the informed consent requirement if it reviews and approves a
				  research study in accordance with federal regulations for the protection of
				  human research subjects including U.S. Department of Health and Human Services
				  (HHS) regulations under 45 CFR Part 46 and U.S. Food and Drug Administration
				  (FDA) regulations under 21 CFR Parts 50 and 56. 45 CFR Part 46 and 21 CFR Parts
				  50 and 56 are incorporated by reference, including subsequent amendments and
				  editions. These regulations may be accessed at
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html
at no cost. For any research study proposed for conduct under an FDA "Exception
				  from Informed Consent Requirements for Emergency Research" or an HHS "Emergency
				  Research Consent Waiver" that waives informed consent but community
				  consultation and public disclosure about the research are required, any
				  facility proposing to be engaged in the research study shall also verify that
				  the proposed research study has been registered with the North Carolina Medical
				  Care Commission. When the IRB has authorized the start of the community
				  consultation process required for emergency research, but before the beginning
				  of that process, notice of the proposed research study shall be provided to the
				  North Carolina Medical Care Commission. The notice shall include:
(a) the title of the research
				  study;
(b) a description of the
				  research study, including a description of the population to be
				  enrolled;
(c) a description of the
				  planned community consultation process, including proposed meeting dates and
				  times;
(d) instructions for opting
				  out of the research study; and
(e)
				  contact information including mailing address and phone number for the IRB and
				  the principal investigator.
The Medical Care Commission may publish all or part of the
					 above information in the North Carolina Register, in accordance with
					 26 NCAC
					 02C.0307, and may require the institution
					 proposing to conduct the research study to attend a public meeting convened by
					 a Medical Care Commission member in the community where the proposed research
					 study is to take place to present and discuss the study or the community
					 consultation process proposed.