42 C.F.R. PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
Title 42 - Public Health
Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Source: 51 FR 22042, June 17, 1986, unless otherwise noted.
(a) Statutory basis. (1) Section 1861(e) of the Act provides that— (i) Hospitals participating in Medicare must meet certain specified requirements; and (ii) The Secretary may impose additional requirements if they are found necessary in the interest of the health and safety of the individuals who are furnished services in hospitals. (2) Section 1861(f) of the Act provides that an institution participating in Medicare as a psychiatric hospital must meet certain specified requirements imposed on hospitals under section 1861(e), must be primarily engaged in providing, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of mentally ill persons, must maintain clinical records and other records that the Secretary finds necessary, and must meet staffing requirements that the Secretary finds necessary to carry out an active program of treatment for individuals who are furnished services in the hospital. A distinct part of an institution can participate as a psychiatric hospital if the institution meets the specified 1861(e) requirements and is primarily engaged in providing psychiatric services, and if the distinct part meets the records and staffing requirements that the Secretary finds necessary. (3) Sections 1861(k) and 1902(a)(30) of the Act provide that hospitals participating in Medicare and Medicaid must have a utilization review plan that meets specified requirements. (4) Section 1883 of the Act sets forth the requirements for hospitals that provide long term care under an agreement with the Secretary. (5) Section 1905(a) of the Act provides that “medical assistance” (Medicaid) payments may be applied to various hospital services. Regulations interpreting those provisions specify that hospitals receiving payment under Medicaid must meet the requirements for participation in Medicare (except in the case of medical supervision of nurse-midwife services. See §§440.10 and 440.165 of this chapter.). (b) Scope. Except as provided in subpart A of part 488 of this chapter, the provisions of this part serve as the basis of survey activities for the purpose of determining whether a hospital qualifies for a provider agreement under Medicare and Medicaid. [51 FR 22042, June 17, 1986, as amended at 60 FR 50442, Sept. 29, 1995] (a) The services of an institution that does not have an agreement to participate in the Medicare program may, nevertheless, be reimbursed under the program if— (1) The services are emergency services; and (2) The institution meets the requirements of section 1861(e) (1) through (5) and (7) of the Act. Rules applicable to emergency services furnished by nonparticipating hospitals are set forth in subpart G of part 424 of this chapter. (b) Section 440.170(e) of this chapter defines emergency hospital services for purposes of Medicaid reimbursement. [51 FR 22042, June 17, 1986, as amended at 53 FR 6648, Mar. 2, 1988] (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] The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital's governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. (a) Standard: Program scope. (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes and identify and reduce medical errors. (2) The hospital must measure, analyze, and track quality indicators, including adverse patient events, and other aspects of performance that assess processes of care, hospital service and operations. (b) Standard: Program data. (1) The program must incorporate quality indicator data including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital's Quality Improvement Organization. (2) The hospital must use the data collected to— (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement and changes that will lead to improvement. (3) The frequency and detail of data collection must be specified by the hospital's governing body. (c) Standard: Program activities. (1) The hospital must set priorities for its performance improvement activities that— (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. (d) Standard: Performance improvement projects. As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects. (1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital's services and operations. (2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes. (3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects. (4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort. (e) Standard: Executive responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: (1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained. (2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety; and that all improvement actions are evaluated. (3) That clear expectations for safety are established. (4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital's performance and reducing risk to patients. (5) That the determination of the number of distinct improvement projects is conducted annually. [68 FR 3454, Jan. 24, 2003] The hospital must have an organized medical staff that operates under bylaws approved by the governing body and is responsible for the quality of medical care provided to patients by the hospital. (a) Standard: Composition of the medical staff. The medical staff must be composed of doctors of medicine or osteopathy and, in accordance with State law, may also be composed of other practitioners appointed by the governing body. (1) The medical staff must periodically conduct appraisals of its members. (2) The medical staff must examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates. (b) Standard: Medical staff organization and accountability. The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to an individual doctor of medicine or osteopathy or, when permitted by State law of the State in which the hospital is located, a doctor of dental surgery or dental medicine. (c) Standard: Medical staff bylaws. The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must: (1) Be approved by the governing body. (2) Include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, etc.) (3) Describe the organization of the medical staff. (4) Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body. (5) Include a requirement that a physical examination and medical history be done no more than 7 days before or 48 hours after an admission for each patient by a doctor of medicine or osteopathy, or, for patients admitted only for oromaxillofacial surgery, by an oromaxillofacial surgeon who has been granted such privileges by the medical staff in accordance with State law. (6) Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. (d) Standard: Autopsies. The medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. The mechanism for documenting permission to perform an autopsy must be defined. There must be a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed. [51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994] The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. (a) Standard: Organization. The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. (b) Standard: Staffing and delivery of care. The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient. (1) The hospital must provide 24-hour nursing services furnished or supervised by a registered nurse, and have a licensed practical nurse or registered nurse on duty at all times, except for rural hospitals that have in effect a 24-hour nursing waiver granted under §405.1910(c) of this chapter. (2) The nursing service must have a procedure to ensure that hospital nursing personnel for whom licensure is required have valid and current licensure. (3) A registered nurse must supervise and evaluate the nursing care for each patient. (4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient. (5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available. (6) Non-employee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing service. (c) Standard: Preparation and administration of drugs. Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under §482.12(c), and accepted standards of practice. (1) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. (2) All orders for drugs and biologicals must be in writing and signed by the practitioner or practitioners responsible for the care of the patient as specified under §482.12(c) with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment for contraindications. When telephone or oral orders must be used, they must be— (i) Accepted only by personnel that are authorized to do so by the medical staff policies and procedures, consistent with Federal and State law; (ii) Signed or initialed by the prescribing practitioner as soon as possible; and (iii) Used infrequently. (3) Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. If blood transfusions and intravenous medications are administered by personnel other than doctors of medicine or osteopathy, the personnel must have special training for this duty. (4) There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs. [51 FR 22042, June 17, 1986, as amended at 67 FR 61814, Oct. 2, 2002] The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital. (a) Standard: Organization and staffing. The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records. (b) Standard: Form and retention of record. The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentification and protects the security of all record entries. (1) Medical records must be retained in their original or legally reproduced form for a period of at least 5 years. (2) The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies. (3) The hospital must have a procedure for ensuring the confidentiality of patient records. In-formation from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas. (c) Standard: Content of record. The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services. (1) All entries must be legible and complete, and must be authenticated and dated promptly by the person (identified by name and discipline) who is responsible for ordering, providing, or evaluating the service furnished. (i) The author of each entry must be identifed and must authenticate his or her entry. (ii) Authentication may include signatures, written initials or computer entry. (2) All records must document the following, as appropriate: (i) Evidence of a physical examination, including a health history, performed no more than 7 days prior to admission or within 48 hours after admission. (ii) Admitting diagnosis. (iii) Results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient. (iv) Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia. (v) Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent. (vi) All practitioners' orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient's condition. (vii) Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow-up care. (viii) Final diagnosis with completion of medical records within 30 days following discharge. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical service. (a) Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. (2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services. (3) Current and accurate records must be kept of the receipt and disposition of all scheduled drugs. (b) Standard: Delivery of services. In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. (1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws. (2) Drugs and biologicals must be kept in a locked storage area. (3) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use. (4) When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law. (5) Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. (6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital-wide quality assurance program. (7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate. (8) Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff. (9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986] The hospital must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. (a) Standard: Radiologic services. The hospital must maintain, or have available, radiologic services according to needs of the patients. (b) Standard: Safety for patients and personnel. The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel. (1) Proper safety precutions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use, and disposal of radioactive materials. (2) Periodic inspection of equipment must be made and hazards identified must be promptly corrected. (3) Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure. (4) Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with State law, of other practitioners authorized by the medical staff and the governing body to order the services. (c) Standard: Personnel. (1) A qualified full-time, part-time, or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology. (2) Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures. (d) Standard: Records. Records of radiologic services must be maintained. (1) The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations. (2) The hospital must maintain the following for at least 5 years: (i) Copies of reports and printouts. (ii) Films, scans, and other image records, as appropriate. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986] (a) The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with part 493 of this chapter. (b) Standard: Adequacy of laboratory services. The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets requirements of part 493 of this chapter. (1) Emergency laboratory services must be available 24 hours a day. (2) A written description of services provided must be available to the medical staff. (3) The laboratory must make provision for proper receipt and reporting of tissue specimens. (4) The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations. (c) Standard: Potentially infectious blood and blood products—(1) Potentially HIV infectious blood and blood products are prior collections from a donor who tested negative at the time of donation but tests repeatedly reactive for the antibody to the human immunodeficiency virus (HIV) on a later donation, and the FDA-licensed, more specific test or other followup testing recommended or required by FDA is positive and the timing of seroconversion cannot be precisely estimated. (2) Services furnished by an outside blood bank. If a hospital regularly uses the services of an outside blood bank, it must have an agreement with the blood bank that governs the procurement, transfer, and availability of blood and blood products. The agreement must require that the blood bank promptly notify the hospital of the following: (i) If it supplied blood and blood products collected from a donor who tested negative at the time of donation but tests repeatedly reactive for the antibody to HIV on a later donation; and (ii) The results of the FDA-licensed, more specific test or other followup testing recommended or required by FDA completed within 30 calendar days after the donor's repeatedly reactive screening test. (FDA regulations concerning HIV testing and lookback procedures are set forth at 21 CFR 610.45-et seq.) (3) Quarantine of blood and blood products pending completion of testing. If the blood bank notifies the hospital of the repeatedly reactive HIV screening test results as required by paragraph (c)(2)(i) of this section, the hospital must determine the disposition of the blood or blood product and quarantine all blood and blood products from previous donations in inventory. (i) If the blood bank notifies the hospital that the result of the FDA-licensed, more specific test or other followup testing recommended or required by FDA is negative, absent other informative test results, the hospital may release the blood and blood products from quarantine. (ii) If the blood bank notifies the hospital that the result of the FDA-licensed, more specific test or other followup testing recommended or required by FDA is positive, the hospital must dispose of the blood and blood products in accordance with 21 CFR 606.40 and notify patients in accordance with paragraph (c)(4) of this section. (4) Patient notification. If the hospital has administered potentially HIV infectious blood or blood products (either directly through its own blood bank or under an agreement described in paragraph (c)(2) of this section) or released such blood or blood products to another entity or appropriate individual, the hospital must take the following actions: (i) Promptly make at least three attempts to notify the patient's attending physician (that is, the physician of record) or the physician who ordered the blood or blood product that potentially HIV infectious blood or blood products were transfused to the patient. (ii) Ask the physician to immediately notify the patient, or other individual as permitted under paragraph (c)(8) of this section, of the need for HIV testing and counseling. (iii) If the physician is unavailable, declines to make the notification, or later informs the hospital that he or she was unable to notify the patient, promptly make at least three attempts to notify the patient, or other individual as permitted under paragraph (c)(8) of this section, of the need for HIV testing and counseling. (iv) Document in the patient's medical record the notification or attempts to give the required notification. (5) Timeframe for notification. The notification effort begins when the blood bank notifies the hospital that it received potentially HIV infectious blood and blood products and continues for 8 weeks unless— (i) The patient is located and notified; or (ii) The hospital is unable to locate the patient and documents in the patient's medical record the extenuating circumstances beyond the hospital's control that caused the notification timeframe to exceed 8 weeks. (6) Content of notification. The notification given under paragraphs (c)(4) (ii) and (iii) of this section must include the following information: (i) A basic explanation of the need for HIV testing and counseling. (ii) Enough oral or written information so that the transfused patient can make an informed decision about whether to obtain HIV testing and counseling. (iii) A list of programs or places where the patient can obtain HIV testing and counseling, including any requirements or restrictions the program may impose. (7) Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for confidentiality and medical records. (8) Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient's behalf, the physician or hospital must notify the patient or his or her legal representative or relative. If the patient is deceased, the physician or hospital must continue the notification process and inform the deceased patient's legal representative or relative. [57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996] The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. (a) Standard: Organization. (1) The hospital must have a full-time employee who— (i) Serves as director of the food and dietetic service; (ii) Is responsible for the daily management of the dietary services; and (iii) Is qualified by experience or training. (2) There must be a qualified dietitian, full-time, part-time, or on a consultant basis. (3) There must be administrative and technical personnel competent in their respective duties. (b) Standard: Diets. Menus must meet the needs of the patients. (1) Therapeutic diets must be prescribed by the practitioner or practitioners responsible for the care of the patients. (2) Nutritional needs must be met in accordance with recognized dietary practices and in accordance with orders of the practitioner or practitioners responsible for the care of the patients. (3) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel. The hospital must have in effect a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients entitled to benefits under the Medicare and Medicaid programs. (a) Applicability. The provisions of this section apply except in either of the following circumstances: (1) A Utilization and Quality Control Quality Improvement Organization (QIO) has assumed binding review for the hospital. (2) CMS has determined that the UR procedures established by the State under title XIX of the Act are superior to the procedures required in this section, and has required hospitals in that State to meet the UR plan requirements under §§456.50 through 456.245 of this chapter. (b) Standard: Composition of utilization review committee. A UR committee consisting of two or more practitioners must carry out the UR function. At least two of the members of the committee must be doctors of medicine or osteopathy. The other members may be any of the other types of practitioners specified in §482.12(c)(1). (1) Except as specified in paragraphs (b) (2) and (3) of this section, the UR committee must be one of the following: (i) A staff committee of the institution; (ii) A group outside the institution— (A) Established by the local medical society and some or all of the hospitals in the locality; or (B) Established in a manner approved by CMS. (2) If, because of the small size of the institution, it is impracticable to have a properly functioning staff committee, the UR committee must be established as specified in paragraph (b)(1)(ii) of this section. (3) The committee's or group's reviews may not be conducted by any individual who— (i) Has a direct financial interest (for example, an ownership interest) in that hospital; or (ii) Was professionally involved in the care of the patient whose case is being reviewed. (c) Standard: Scope and frequency of review. (1) The UR plan must provide for review for Medicare and Medicaid patients with respect to the medical necessity of— (i) Admissions to the institution; (ii) The duration of stays; and (iii) Professional services furnished, including drugs and biologicals. (2) Review of admissions may be performed before, at, or after hospital admission. (3) Except as specified in paragraph (e) of this section, reviews may be conducted on a sample basis. (4) Hospitals that are paid for inpatient hospital services under the prospective payment system set forth in Part 412 of this chapter must conduct review of duration of stays and review of professional services as follows: (i) For duration of stays, these hospitals need review only cases that they reasonably assume to be outlier cases based on extended length of stay, as described in §412.80(a)(1)(i) of this chapter; and (ii) For professional services, these hospitals need review only cases that they reasonably assume to be outlier cases based on extraordinarily high costs, as described in §412.80(a)(1)(ii) of this chapter. (d) Standard: Determination regarding admissions or continued stays. (1) The determination that an admission or continued stay is not medically necessary— (i) May be made by one member of the UR committee if the practitioner or practitioners responsible for the care of the patient, as specified of §482.12(c), concur with the determination or fail to present their views when afforded the opportunity; and (ii) Must be made by at least two members of the UR committee in all other cases. (2) Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner or practitioners responsible for the care of the patient, as specified in §482.12(c), and afford the practitioner or practitioners the opportunity to present their views. (3) If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination, to the hospital, the patient, and the practitioner or practitioners responsible for the care of the patient, as specified in §482.12(c); (e) Standard: Extended stay review. (1) In hospitals that are not paid under the prospective payment system, the UR committee must make a periodic review, as specified in the UR plan, of each current inpatient receiving hospital services during a continuous period of extended duration. The scheduling of the periodic reviews may— (i) Be the same for all cases; or (ii) Differ for different classes of cases. (2) In hospitals paid under the prospective payment system, the UR committee must review all cases reasonably assumed by the hospital to be outlier cases because the extended length of stay exceeds the threshold criteria for the diagnosis, as described in §412.80(a)(1)(i). The hospital is not required to review an extended stay that does not exceed the outlier threshold for the diagnosis. (3) The UR committee must make the periodic review no later than 7 days after the day required in the UR plan. (f) Standard: Review of professional services. The committee must review professional services provided, to determine medical necessity and to promote the most efficient use of available health facilities and services. The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community. (a) Standard: Buildings. The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. (1) There must be emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available. (2) There must be facilities for emergency gas and water supply. (b) Standard: Life safety from fire. (1) Except as otherwise provided in this section— (i) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to hospitals. (2) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon the facility, but only if the waiver does not adversely affect the health and safety of the patients. (3) The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients in hospitals. (4) Beginning March 13, 2006, a hospital must be in compliance with Chapter 19.2.9, Emergency Lighting. (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to hospitals. (6) The hospital must have procedures for the proper routine storage and prompt disposal of trash. (7) The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities. (8) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies. (9) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a hospital may install alcohol-based hand rub dispensers in its facility if— (i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities; (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; (iii) The dispensers are installed in a manner that adequately protects against access by vulnerable populations; and (iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any additional changes are made to this amendment, CMS will publish notice in the (c) Standard: Facilities. The hospital must maintain adequate facilities for its services. (1) Diagnostic and therapeutic facilities must be located for the safety of patients. (2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. (3) The extent and complexity of facilities must be determined by the services offered. (4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. [51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005] The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. (a) Standard: Organization and policies. A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases. (1) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. (2) The infection control officer or officers must maintain a log of incidents related to infections and communicable diseases. (b) Standard: Responsibilities of chief executive officer, medical staff, and director of nursing services. The chief executive officer, the medical staff, and the director of nursing services must— (1) Ensure that the hospital-wide quality assurance program and training programs address problems identified by the infection control officer or officers; and (2) Be responsible for the implementation of successful corrective action plans in affected problem areas. The hospital must have in effect a discharge planning process that applies to all patients. The hospital's policies and procedures must be specified in writing. (a) Standard: Identification of patients in need of discharge planning. The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning. (b) Standard: Discharge planning evaluation. (1) The hospital must provide a discharge planning evaluation to the patients identified in paragraph (a) of this section, and to other patients upon the patient's request, the request of a person acting on the patient's behalf, or the request of the physician. (2) A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, the evaluation. (3) The discharge planning evaluation must include an evaluation of the likelihood of a patient needing post- hospital services and of the availability of the services. (4) The discharge planning evaluation must include an evaluation of the likelihood of a patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the hospital. (5) The hospital personnel must complete the evaluation on a timely basis so that appropriate arrangements for post-hospital care are made before discharge, and to avoid unnecessary delays in discharge. (6) The hospital must include the discharge planning evaluation in the patient's medical record for use in establishing an appropriate discharge plan and must discuss the results of the evaluation with the patient or individual acting on his or her behalf. (c) Standard: Discharge plan. (1) A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, a discharge plan if the discharge planning evaluation indicates a need for a discharge plan. (2) In the absence of a finding by the hospital that a patient needs a discharge plan, the patient's physician may request a discharge plan. In such a case, the hospital must develop a discharge plan for the patient. (3) The hospital must arrange for the initial implementation of the patient's discharge plan. (4) The hospital must reassess the patient's discharge plan if there are factors that may affect continuing care needs or the appropriateness of the discharge plan. (5) As needed, the patient and family members or interested persons must be counseled to prepare them for post-hospital care. (6) The hospital must include in the discharge plan a list of HHAs or SNFs that are available to the patient, that are participating in the Medicare program, and that serve the geographic area (as defined by the HHA) in which the patient resides, or in the case of a SNF, in the geographic area requested by the patient. HHAs must request to be listed by the hospital as available. (i) This list must only be presented to patients for whom home health care or post-hospital extended care services are indicated and appropriate as determined by the discharge planning evaluation. (ii) For patients enrolled in managed care organizations, the hospital must indicate the availability of home health and posthospital extended care services through individuals and entities that have a contract with the managed care organizations. (iii) The hospital must document in the patient's medical record that the list was presented to the patient or to the individual acting on the patient's behalf. (7) The hospital, as part of the discharge planning process, must inform the patient or the patient's family of their freedom to choose among participating Medicare providers of posthospital care services and must, when possible, respect patient and family preferences when they are expressed. The hospital must not specify or otherwise limit the qualified providers that are available to the patient. (8) The discharge plan must identify any HHA or SNF to which the patient is referred in which the hospital has a disclosable financial interest, as specified by the Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital under Medicare. Financial interests that are disclosable under Medicare are determined in accordance with the provisions of Part 420, Subpart C, of this chapter. (d) Standard: Transfer or referral. The hospital must transfer or refer patients, along with necessary medical information, to appropriate facilities, agencies, or outpatient services, as needed, for followup or ancillary care. (e) Standard: Reassessment. The hospital must reassess its discharge planning process on an on-going basis. The reassessment must include a review of discharge plans to ensure that they are responsive to discharge needs. [59 FR 64152, Dec. 13, 1994, as amended at 69 FR 49268, Aug. 11, 2004] (a) Standard: Organ procurement responsibilities. The hospital must have and implement written protocols that: (1) Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose; (2) Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement; (3) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes or to decline to donate. The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation; (4) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors; (5) Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place. (b) Standard: Organ transplantation responsibilities. (1) A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term “rules of the OPTN” means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act, or with the requirements of this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing. (2) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas. (3) If a hospital performs any type of transplants, it must provide organ-transplant-related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide such data directly to the Department when requested by the Secretary. [63 FR 33875, June 22, 1998] If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. (a) Standard: Organization and staffing. The organization of the surgical services must be appropriate to the scope of the services offered. (1) The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy. (2) Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as “scrub nurses” under the supervision of a registered nurse. (3) Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the surpervision of a qualified registered nurse who is immediately available to respond to emergencies. (4) Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner. (b) Standard: Delivery of service. Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. (1) There must be a complete history and physical work-up in the chart of every patient prior to surgery, except in emergencies. If this has been dictated, but not yet recorded in the patient's chart, there must be a statement to that effect and an admission note in the chart by the practitioner who admitted the patient. (2) A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies. (3) The following equipment must be available to the operating room suites: call-in-system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set. (4) There must be adequate provisions for immediate post-operative care. (5) The operating room register must be complete and up-to-date. (6) An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon. If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital. (a) Standard: Organization and staffing. The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by— (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c)of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist's assistant, as defined in §410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed. (b) Standard: Delivery of services. Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of preanesthesia and post anesthesia responsibilities. The policies must ensure that the following are provided for each patient: (1) A preanesthesia evaluation by an individual qualified to administer anesthesia under paragraph (a) of this section performed within 48 hours prior to surgery. (2) An intraoperative anesthesia record. (3) With respect to inpatients, a postanesthesia followup report by the individual who administers the anesthesia that is written within 48 hours after surgery. (4) With respect to outpatients, a postanesthesia evaluation for proper anesthesia recovery performed in accordance with policies and procedures approved by the medical staff. (c) Standard: State exemption. (1) A hospital may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital is located submits a letter to CMS signed by the Governor, following consultation with the State's Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law. (2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission. [51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, 2001] If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice. (a) Standard: Organization and staffing. The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered. (1) There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine. (2) The qualifications, training, functions, and responsibilities of nuclear medicine personnel must be specified by the service director and approved by the medical staff. (b) Standard: Delivery of service. Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice. (1) In-house preparation of radiopharmaceuticals is by, or under, the direct supervision of an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. (2) There is proper storage and disposal of radioactive material. (3) If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services specified in §482.27. (c) Standard: Facilities. Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be— (1) Maintained in safe operating condition; and (2) Inspected, tested, and calibrated at least annually by qualified personnel. (d) Standard: Records. The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures. (1) The hospital must maintain copies of nuclear medicine reports for at least 5 years. (2) The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests. (3) The hospital must maintain records of the receipt and disposition of radiopharmaceuticals. (4) Nuclear medicine services must be ordered only by practitioner whose scope of Federal or State licensure and whose defined staff privileges allow such referrals. [51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992] If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice. (a) Standard: Organization. Outpatient services must be appropriately organized and integrated with inpatient services. (b) Standard: Personnel. The hospitals must— (1) Assign an individual to be responsible for outpatient services; and (2) Have appropriate professional and nonprofessional personnel available. The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. (a) Standard: Organization and direction. If emergency services are provided at the hospital— (1) The services must be organized under the direction of a qualified member of the medical staff; (2) The services must be integrated with other departments of the hospital; (3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff. (b) Standard: Personnel. (1) The emergency services must be supervised by a qualified member of the medical staff. (2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients. (a) Standard: Organization and staffing. The organization of the service must be appropriate to the scope of the services offered. (1) The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services. (2) Physical therapy, occupational therapy, or speech therapy, or audiology services, if provided, must be provided by staff who meet the qualifications specified by the medical staff, consistent with State law. (b) Standard: Delivery of services. Services must be furnished in accordance with a written plan of treatment. Services must be given in accordance with orders of practitioners who are authorized by the medical staff to order the services, and the orders must be incorporated in the patient's record. The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care service. (a) Standard: Organization and Staffing. The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered. (1) There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge experience, and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis. (2) There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law. (b) Standard: Delivery of Services. Services must be delivered in accordance with medical staff directives. (1) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing. (2) If blood gases or other laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services specified in §482.27. (3) Services must be provided only on, and in accordance with, the orders of a doctor of medicine or osteopathy. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 FR 7136, Feb. 28, 1992] Psychiatric hospital must— (a) Be primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of mentally ill persons; (b) Meet the conditions of participation specified in §§482.1 through 482.23 and §§482.25 through 482.57; (c) Maintain clinical records on all patients, including records sufficient to permit CMS to determine the degree and intensity of treatment furnished to Medicare beneficiaries, as specified in §482.61; and (d) Meet the staffing requirements specified in §482.62. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986] The medical records maintained by a psychiatric hospital must permit determination of the degree and intensity of the treatment provided to individuals who are furnished services in the institution. (a) Standard: Development of assessment/diagnostic data. Medical records must stress the psychiatric components of the record, including history of findings and treatment provided for the psychiatric condition for which the patient is hospitalized. (1) The identification data must include the patient's legal status. (2) A provisional or admitting diagnosis must be made on every patient at the time of admission, and must include the diagnoses of intercurrent diseases as well as the psychiatric diagnoses. (3) The reasons for admission must be clearly documented as stated by the patient and/or others significantly involved. (4) The social service records, including reports of interviews with patients, family members, and others, must provide an assessment of home plans and family attitudes, and community resource contacts as well as a social history. (5) When indicated, a complete neurological examination must be recorded at the time of the admission physical examination. (b) Standard: Psychiatric evaluation. Each patient must receive a psychiatric evaluation that must— (1) Be completed within 60 hours of admission; (2) Include a medical history; (3) Contain a record of mental status; (4) Note the onset of illness and the circumstances leading to admission; (5) Describe attitudes and behavior; (6) Estimate intellectual functioning, memory functioning, and orientation; and (7) Include an inventory of the patient's assets in descriptive, not interpretative, fashion. (c) Standard: Treatment plan. (1) Each patient must have an individual comprehensive treatment plan that must be based on an inventory of the patient's strengths and disabilities. The written plan must include— (i) A substantiated diagnosis; (ii) Short-term and long-range goals; (iii) The specific treatment modalities utilized; (iv) The responsibilities of each member of the treatment team; and (v) Adequate documentation to justify the diagnosis and the treatment and rehabilitation activities carried out. (2) The treatment received by the patient must be documented in such a way to assure that all active therapeutic efforts are included. (d) Standard: Recording progress. Progress notes must be recorded by the doctor of medicine or osteopathy responsible for the care of the patient as specified in §482.12(c), nurse, social worker and, when appropriate, others significantly involved in active treatment modalities. The frequency of progress notes is determined by the condition of the patient but must be recorded at least weekly for the first 2 months and at least once a month thereafter and must contain recommendations for revisions in the treatment plan as indicated as well as precise assessment of the patient's progress in accordance with the original or revised treatment plan. (e) Standard: Discharge planning and discharge summary. The record of each patient who has been discharged must have a discharge summary that includes a recapitulation of the patient's hospitalization and recommendations from appropriate services concerning follow-up or aftercare as well as a brief summary of the patient's condition on discharge. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986] The hospital must have adequate numbers of qualified professional and supportive staff to evaluate patients, formulate written, individualized comprehensive treatment plans, provide active treatment measures, and engage in discharge planning. (a) Standard: Personnel. The hospital must employ or undertake to provide adequate numbers of qualified professional, technical, and consultative personnel to: (1) Evaluate patients; (2) Formulate written individualized, comprehensive treatment plans; (3) Provide active treatment measures; and (4) Engage in discharge planning. (b) Standard: Director of inpatient psychiatric services; medical staff. Inpatient psychiatric services must be under the supervision of a clinical director, service chief, or equivalent who is qualified to provide the leadership required for an intensive treatment program. The number and qualifications of doctors of medicine and osteopathy must be adequate to provide essential psychiatric services. (1) The clinical director, service chief, or equivalent must meet the training and experience requirements for examination by the American Board of Psychiatry and Neurology or the American Osteopathic Board of Neurology and Psychiatry. (2) The director must monitor and evaluate the quality and appropriateness of services and treatment provided by the medical staff. (c) Standard: Availability of medical personnel. Doctors of medicine or osteopathy and other appropriate professional personnel must be available to provide necessary medical and surgical diagnostic and treatment services. If medical and surgical diagnostic and treatment services are not available within the institution, the institution must have an agreement with an outside source of these services to ensure that they are immediately available or a satisfactory agreement must be established for transferring patients to a general hospital that participates in the Medicare program. (d) Standard: Nursing services. The hospital must have a qualified director of psychiatric nursing services. In addition to the director of nursing, there must be adequate numbers of registered nurses, licensed practical nurses, and mental health workers to provide nursing care necessary under each patient's active treatment program and to maintain progress notes on each patient. (1) The director of psychiatric nursing services must be a registered nurse who has a master's degree in psychiatric or mental health nursing, or its equivalent from a school of nursing accredited by the National League for Nursing, or be qualified by education and experience in the care of the mentally ill. The director must demonstrate competence to participate in interdisciplinary formulation of individual treatment plans; to give skilled nursing care and therapy; and to direct, monitor, and evaluate the nursing care furnished. (2) The staffing pattern must insure the availability of a registered professional nurse 24 hours each day. There must be adequate numbers of registered nurses, licensed practical nurses, and mental health workers to provide the nursing care necessary under each patient's active treatment program. (e) Standard: Psychological services. The hospital must provide or have available psychological services to meet the needs of the patients. (f) Standard: Social services. There must be a director of social services who monitors and evaluates the quality and appropriateness of social services furnished. The services must be furnished in accordance with accepted standards of practice and established policies and procedures. (1) The director of the social work department or service must have a master's degree from an accredited school of social work or must be qualified by education and experience in the social services needs of the mentally ill. If the director does not hold a masters degree in social work, at least one staff member must have this qualification. (2) Social service staff responsibilities must include, but are not limited to, participating in discharge planning, arranging for follow-up care, and developing mechanisms for exchange of appropriate, information with sources outside the hospital. (g) Standard: Therapeutic activities. The hospital must provide a therapeutic activities program. (1) The program must be appropriate to the needs and interests of patients and be directed toward restoring and maintaining optimal levels of physical and psychosocial functioning. (2) The number of qualified therapists, support personnel, and consultants must be adequate to provide comprehensive therapeutic activities consistent with each patient's active treatment program. [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986] A hospital that has a Medicare provider agreement must meet the following requirements in order to be granted an approval from CMS to provide post-hospital extended care services, as specified in §409.30 of this chapter, and be reimbursed as a swing-bed hospital, as specified in §413.114 of this chapter: (a) Eligibility. A hospital must meet the following eligibility requirements: (1) The facility has fewer than 100 hospital beds, excluding beds for newborns and beds in intensive care type inpatient units (for eligibility of hospitals with distinct parts electing the optional reimbursement method, see §413.24(d)(5) of this chapter). (2) The hospital is located in a rural area. This includes all areas not delineated as “urbanized” areas by the Census Bureau, based on the most recent census. (3) The hospital does not have in effect a 24-hour nursing waiver granted under §488.54(c) of this chapter. (4) The hospital has not had a swing-bed approval terminated within the two years previous to application. (b) Skilled nursing facility services. The facility is substantially in compliance with the following skilled nursing facility requirements contained in subpart B of part 483 of this chapter. (1) Resident rights (§483.10 (b)(3), (b)(4), (b)(5), (b)(6), (d), (e), (h), (i), (j)(1)(vii), (j)(1)(viii), (l), and (m)). (2) Admission, transfer, and discharge rights (§483.12 (a)(1), (a)(2), (a)(3), (a)(4), (a)(5), (a)(6), and (a)(7)). (3) Resident behavior and facility practices (§483.13). (4) Patient activities (§483.15(f)). (5) Social services (§483.15(g)). (6) Discharge planning (§483.20(e)). (7) Specialized rehabilitative services (§483.45). (8) Dental services (§483.55). [51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 51 FR 34833, Sept. 30, 1986; 54 FR 37275, Sept. 7, 1989; 56 FR 54546, Oct. 22, 1991; 59 FR 45403, Sept. 1, 1994; 65 FR 47052, Aug. 1, 2000]
Title 42: Public Health
PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
Section Contents
§ 482.1 Basis and scope.
§ 482.2 Provision of emergency services by nonparticipating hospitals.
§ 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.
§ 482.21 Condition of participation: Quality assessment and performance improvement program.
§ 482.22 Condition of participation: Medical staff.
§ 482.23 Condition of participation: Nursing services.
§ 482.24 Condition of participation: Medical record services.
§ 482.25 Condition of participation: Pharmaceutical services.
§ 482.26 Condition of participation: Radiologic services.
§ 482.27 Condition of participation: Laboratory services.
§ 482.28 Condition of participation: Food and dietetic services.
§ 482.30 Condition of participation: Utilization review.
§ 482.41 Condition of participation: Physical environment.
§ 482.42 Condition of participation: Infection control.
§ 482.43 Condition of participation: Discharge planning.
§ 482.45 Condition of participation: Organ, tissue, and eye procurement.
§ 482.51 Condition of participation: Surgical services.
§ 482.52 Condition of participation: Anesthesia services.
§ 482.53 Condition of participation: Nuclear medicine services.
§ 482.54 Condition of participation: Outpatient services.
§ 482.55 Condition of participation: Emergency services.
§ 482.56 Condition of participation: Rehabilitation services.
§ 482.57 Condition of participation: Respiratory care services.
§ 482.60 Special provisions applying to psychiatric hospitals.
§ 482.61 Condition of participation: Special medical record requirements for psychiatric hospitals.
§ 482.62 Condition of participation: Special staff requirements for psychiatric hospitals.
§ 482.66 Special requirements for hospital providers of long-term care services (“swing-beds”).
Subpart A—General Provisions
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§ 482.1 Basis and scope.
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§ 482.2 Provision of emergency services by nonparticipating hospitals.
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Subpart B—Administration
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§ 482.11 Condition of participation: Compliance with Federal, State and local laws.
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§ 482.12 Condition of participation: Governing body.
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§ 482.13 Condition of participation: Patients' rights.
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Subpart C—Basic Hospital Functions
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§ 482.21 Condition of participation: Quality assessment and performance improvement program.
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§ 482.22 Condition of participation: Medical staff.
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§ 482.23 Condition of participation: Nursing services.
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§ 482.24 Condition of participation: Medical record services.
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§ 482.25 Condition of participation: Pharmaceutical services.
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§ 482.26 Condition of participation: Radiologic services.
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§ 482.27 Condition of participation: Laboratory services.
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§ 482.28 Condition of participation: Food and dietetic services.
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§ 482.30 Condition of participation: Utilization review.
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§ 482.41 Condition of participation: Physical environment.
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§ 482.42 Condition of participation: Infection control.
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§ 482.43 Condition of participation: Discharge planning.
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§ 482.45 Condition of participation: Organ, tissue, and eye procurement.
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Subpart D—Optional Hospital Services
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§ 482.51 Condition of participation: Surgical services.
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§ 482.52 Condition of participation: Anesthesia services.
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§ 482.53 Condition of participation: Nuclear medicine services.
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§ 482.54 Condition of participation: Outpatient services.
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§ 482.55 Condition of participation: Emergency services.
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§ 482.56 Condition of participation: Rehabilitation services.
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§ 482.57 Condition of participation: Respiratory care services.
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Subpart E—Requirements for Specialty Hospitals
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§ 482.60 Special provisions applying to psychiatric hospitals.
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§ 482.61 Condition of participation: Special medical record requirements for psychiatric hospitals.
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§ 482.62 Condition of participation: Special staff requirements for psychiatric hospitals.
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§ 482.66 Special requirements for hospital providers of long-term care services (“swing-beds”).
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