Code of Federal Regulations 42CFR482

[Page 347-366]

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

      Authority: Secs. 1102 and 1871 of the Social Security Act (42U.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.

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      (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 Secs. 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]

Sec. 482.2 Provision of emergency services by nonparticipating hospitals.

      (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) Secton 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.

Sec. 482.12 Condition of participation: Governing body.

      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.

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      (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.
      (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, or a chiropractor, 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.
      (5)(i) To identify potential organ donors as defined in Sec. 485.302 of this chapter, the hospital has written protocols that--
      (A) Assure that the family of each potential organ donor knows of its option either to donate organs or tissues or to decline to donate;
      (B) Encourage discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors; and
      (C) Require that an organ procurement organization designated by the Secretary under Sec. 485.308 of this chapter be notified of potential organ donors.
      (ii) In the case of a hospital in which organ transplants are performed, the hospital 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. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act or with the requirements in 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.
      (iii) For purposes of this subparagraph, the term ``organ'' means a human kidney, liver, heart, lung, or pancreas.
      (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.

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      (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 Sec. 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.

[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]

      The governing body must ensure that there is an effective, hospital-wide quality assurance program to evaluate the provision of patient care.
      (a) Standard: Clinical plan. The organized, hospital-wide quality assurance program must be ongoing and have a written plan of implementation.

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      (1) All organized services related to patient care, including services furnished by a contractor, must be evaluated.
      (2) Nosocomial infections and medication therapy must be evaluated.
      (3) All medical and surgical services performed in the hospital must be evaluated as they relate to appropriateness of diagnosis and treatment.
      (b) Standard: Medically-related patient care services. The hospital must have an ongoing plan, consistent with available community and hospital resources, to provide or make available social work, psychological, and educational services to meet the medically-related needs of its patients.
      (c) Standard: Implementation. The hospital must take and document appropriate remedial action to address deficiencies found through the quality assurance program. The hospital must document the outcome of the remedial action.

[51 FR 22042, June 17, 1986, as amended at 59 FR 64152, Dec. 13, 1994]

Sec. 482.22 Condition of participation: Medical staff.

      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]

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Sec. 482.23 Condition of participation: Nursing services.

      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 Sec. 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 Sec. 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 Sec. 482.12(c). 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.

Sec. 482.24 Condition of participation: Medical record services.

      The hospital must have a medical record service that has administrative responsibility for medical records. A

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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.

Sec. 482.25 Condition of participation: Pharmaceutical services.

      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

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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]

Sec. 482.26 Condition of participation: Radiologic services.

      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.

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      (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]

Sec. 482.27 Condition of participation: Laboratory services.

      (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

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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]

Sec. 482.28 Condition of participation: Food and dietetic services.

      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.

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      (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.

Sec. 482.30 Condition of participation: Utilization review.

      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 Peer Review Organization (PRO) has assumed binding review for the hospital.
      (2) HCFA 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 Secs. 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 Sec. 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 HCFA.
      (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 Sec. 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 Sec. 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--

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      (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 Sec. 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 Sec. 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 Sec. 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 Sec. 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.

Sec. 482.41 Condition of participation: Physical environment.

      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 provided in paragraphs (b)(1)(i) through (b)(1)(iii) of this section, the hospital must meet the applicable provisions of the 1985 edition of the Life Safety Code of the National Fire Protection Association (which is incorporated by reference).\1\

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imposed by State law adequately protects patients in hospitals.
      (2) The hospital must have procedures for the proper routine storage and prompt disposal of trash.
      (3) 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.
      (4) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies.
      (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]

Sec. 482.42 Condition of participation: Infection control.

      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.

Sec. 482.43 Condition of participation: Discharge planning.

      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

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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.
      (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]

      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.

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      (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.

Sec. 482.52 Condition of participation; Anesthesia services.

      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 by only--
      (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 Sec. 410.69(b) of this chapter, who 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 Sec. 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.

[51 FR 22042, June 17, 1986 as amended at 57 FR 33900, July 31, 1992]

Sec. 482.53 Condition of participation: Nuclear medicine services.

      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 Sec. 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.

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      (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]

Sec. 482.54 Condition of participation: Outpatient services.

      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.

Sec. 482.55 Condition of participation: Emergency services.

      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.

Sec. 482.56 Condition of participation: Rehabilitation services.

      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.

Sec. 482.57 Condition of participation: Respiratory care services.

      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.

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      (2) There must be adequate numbers of respiratory therapists, respiratory therapy tech