42 C.F.R. Subpart B—Administration
Title 42 - Public Health
(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients. (b) The hospital must be— (1) Licensed; or (2) Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals. (c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws. The hospital must have an effective governing body legally responsible for the conduct of the hospital as an institution. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body. (a) Standard: Medical staff. The governing body must: (1) Determine, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the medical staff; (2) Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff; (3) Assure that the medical staff has bylaws; (4) Approve medical staff bylaws and other medical staff rules and regulations; (5) Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients; (6) Ensure the criteria for selection are individual character, competence, training, experience, and judgment; and (7) Ensure that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship, or membership in a specialty body or society. (b) Standard: Chief executive officer. The governing body must appoint a chief executive officer who is responsible for managing the hospital. (c) Standard: Care of patients. In accordance with hospital policy, the governing body must ensure that the following requirements are met: (1) Every Medicare patient is under the care of: (i) A doctor of medicine or osteopathy (This provision is not to be construed to limit the authority of a doctor of medicine or osteopathy to delegate tasks to other qualified health care personnel to the extent recognized under State law or a State's regulatory mechanism.); (ii) A doctor of dental surgery or dental medicine who is legally authorized to practice dentistry by the State and who is acting within the scope of his or her license; (iii) A doctor of podiatric medicine, but only with respect to functions which he or she is legally authorized by the State to perform; (iv) A doctor of optometry who is legally authorized to practice optometry by the State in which he or she practices; (v) A chiropractor who is licensed by the State or legally authorized to perform the services of a chiropractor, but only with respect to treatment by means of manual manipulation of the spine to correct a subluxation demonstrated by x-ray to exist; and (vi) A clinical psychologist as defined in §410.71 of this chapter, but only with respect to clinical psychologist services as defined in §410.71 of this chapter and only to the extent permitted by State law. (2) Patients are admitted to the hospital only on the recommendation of a licensed practitioner permitted by the State to admit patients to a hospital. If a Medicare patient is admitted by a practitioner not specified in paragraph (c)(1) of this section, that patient is under the care of a doctor of medicine or osteopathy. (3) A doctor of medicine or osteopathy is on duty or on call at all times. (4) A doctor of medicine or osteopathy is responsible for the care of each Medicare patient with respect to any medical or psychiatric problem that— (i) is present on admission or develops during hospitalization; and (ii) Is not specifically within the scope of practice of a doctor of dental surgery, dental medicine, podiatric medicine, or optometry; a chiropractor; or clinical psychologist, as that scope is— (A) Defined by the medical staff; (B) Permitted by State law; and (C) Limited, under paragraph (c)(1)(v) of this section, with respect to chiropractors. (d) Standard: Institutional plan and budget. The institution must have an overall institutional plan that meets the following conditions: (1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles. (2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense. (3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable. (4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following: (i) Acquisition of land; (ii) Improvement of land, buildings, and equipment; or (iii) The replacement, modernization, and expansion of buildings and equipment. (5) The plan must be submitted for review to the planning agency designated in accordance with section 1122(b) of the Act, or if an agency is not designated, to the appropriate health planning agency in the State. (See part 100 of this title.) A capital expenditure is not subject to section 1122 review if 75 percent of the health care facility's patients who are expected to use the service for which the capital expenditure is made are individuals enrolled in a health maintenance organization (HMO) or competitive medical plan (CMP) that meets the requirements of section 1876(b) of the Act, and if the Department determines that the capital expenditure is for services and facilities that are needed by the HMO or CMP in order to operate efficiently and economically and that are not otherwise readily accessible to the HMO or CMP because— (i) The facilities do not provide common services at the same site; (ii) The facilities are not available under a contract of reasonable duration; (iii) Full and equal medical staff privileges in the facilities are not available; (iv) Arrangements with these facilities are not administratively feasible; or (v) The purchase of these services is more costly than if the HMO or CMP provided the services directly. (6) The plan must be reviewed and updated annually. (7) The plan must be prepared— (i) Under the direction of the governing body; and (ii) By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution. (e) Standard: Contracted services. The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. (1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. (2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. (f) Standard: Emergency services. (1) If emergency services are provided at the hospital, the hospital must comply with the requirements of §482.55. (2) If emergency services are not provided at the hospital, the governing body must assure that the medical staff has written policies and procedures for appraisal of emergencies, initial treatment, and referral when appropriate. (3) If emergency services are provided at the hospital but are not provided at one or more off-campus departments of the hospital, the governing body of the hospital must assure that the medical staff has written policies and procedures in effect with respect to the off-campus department(s) for appraisal of emergencies and referral when appropriate. [51 FR 22042, June 17, 1986; 51 FR 27847, Aug. 4, 1986, as amended at 53 FR 6549, Mar. 1, 1988; 53 FR 18987, May 26, 1988; 56 FR 8852, Mar. 1, 1991; 56 FR 23022, May 20, 1991; 59 FR 46514, Sept. 8, 1994; 63 FR 20130, Apr. 23, 1998; 63 FR 33874, June 22, 1998; 68 FR 53262, Sept. 9, 2003] A hospital must protect and promote each patient's rights. (a) Standard: Notice of rights. (1) A hospital must inform each patient, or when appropriate, the patient's representative (as allowed under State law), of the patient's rights, in advance of furnishing or discontinuing patient care whenever possible. (2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital's governing body must approve and be responsible for the effective operation of the grievance process and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization. At a minimum: (i) The hospital must establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital. (ii) The grievance process must specify time frames for review of the grievance and the provision of a response. (iii) In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. (b) Standard: Exercise of rights. (1) The patient has the right to participate in the development and implementation of his or her plan of care. (2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. (3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). (4) The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital. (c) Standard: Privacy and safety. (1) The patient has the right to personal privacy. (2) The patient has the right to receive care in a safe setting. (3) The patient has the right to be free from all forms of abuse or harassment. (d) Standard: Confidentiality of patient records. (1) The patient has the right to the confidentiality of his or her clinical records. (2) The patient has the right to access information contained in his or her clinical records within a reasonable time frame. The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its recordkeeping system permits. (e) Standard: Restraint for acute medical and surgical care. (1) The patient has the right to be free from restraints of any form that are not medically necessary or are used as a means of coercion, discipline, convenience, or retaliation by staff. The term “restraint” includes either a physical restraint or a drug that is being used as a restraint. A physical restraint is any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body. A drug used as a restraint is a medication used to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition. (2) A restraint can only be used if needed to improve the patient's well-being and less restrictive interventions have been determined to be ineffective. (3) The use of a restraint must be— (i) Selected only when other less restrictive measures have been found to be ineffective to protect the patient or others from harm; (ii) In accordance with the order of a physician or other licensed independent practitioner permitted by the State and hospital to order a restraint. This order must— (A) Never be written as a standing or on an as needed basis (that is, PRN); and (B) Be followed by consultation with the patient's treating physician, as soon as possible, if the restraint is not ordered by the patient's treating physician; (iii) In accordance with a written modification to the patient's plan of care; (iv) Implemented in the least restrictive manner possible; (v) In accordance with safe and appropriate restraining techniques; and (vi) Ended at the earliest possible time. (4) The condition of the restrained patient must be continually assessed, monitored, and reevaluated. (5) All staff who have direct patient contact must have ongoing education and training in the proper and safe use of restraints. (f) Standard: Seclusion and restraint for behavior management. (1) The patient has the right to be free from seclusion and restraints, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. The term “restraint” includes either a physical restraint or a drug that is being used as a restraint. A physical restraint is any manual method or physical or mechanical device, material, or equipment attached or adjacent to the patient's body that he or she cannot easily remove that restricts freedom of movement or normal access to one's body. A drug used as a restraint is a medication used to control behavior or to restrict the patient's freedom of movement and is not a standard treatment for the patient's medical or psychiatric condition. Seclusion is the involuntary confinement of a person in a room or an area where the person is physically prevented from leaving. (2) Seclusion or a restraint can only be used in emergency situations if needed to ensure the patient's physical safety and less restrictive interventions have been determined to be ineffective. (3) The use of a restraint or seclusion must be— (i) Selected only when less restrictive measures have been found to be ineffective to protect the patient or others from harm; (ii) In accordance with the order of a physician or other licensed independent practitioner permitted by the State and hospital to order seclusion or restraint. The following requirements will be superseded by existing State laws that are more restrictive: (A) Orders for the use of seclusion or a restraint must never be written as a standing order or on an as needed basis (that is, PRN). (B) The treating physician must be consulted as soon as possible, if the restraint or seclusion is not ordered by the patient's treating physician. (C) A physician or other licensed independent practitioner must see and evaluate the need for restraint or seclusion within 1 hour after the initiation of this intervention. (D) Each written order for a physical restraint or seclusion is limited to 4 hours for adults; 2 hours for children and adolescents ages 9 to 17; or 1 hour for patients under 9. The original order may only be renewed in accordance with these limits for up to a total of 24 hours. After the original order expires, a physician or licensed independent practitioner (if allowed under State law) must see and assess the patient before issuing a new order. (iii) In accordance with a written modification to the patient's plan of care; (iv) Implemented in the least restrictive manner possible; (v) In accordance with safe appropriate restraining techniques; and (vi) Ended at the earliest possible time. (4) A restraint and seclusion may not be used simultaneously unless the patient is— (i) Continually monitored face-to-face by an assigned staff member; or (ii) Continually monitored by staff using both video and audio equipment. This monitoring must be in close proximity the patient. (5) The condition of the patient who is in a restraint or in seclusion must continually be assessed, monitored, and reevaluated. (6) All staff who have direct patient contact must have ongoing education and training in the proper and safe use of seclusion and restraint application and techniques and alternative methods for handling behavior, symptoms, and situations that traditionally have been treated through the use of restraints or seclusion. (7) The hospital must report to CMS any death that occurs while a patient is restrained or in seclusion, or where it is reasonable to assume that a patient's death is a result of restraint or seclusion. [64 FR 36088, July 2, 1999]
Title 42: Public Health
PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
Subpart B—Administration
§ 482.11 Condition of participation: Compliance with Federal, State and local laws.
§ 482.12 Condition of participation: Governing body.
§ 482.13 Condition of participation: Patients' rights.
