42 C.F.R. Subpart C—Basic Hospital Functions
Title 42 - Public Health
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]
Title 42: Public Health
PART 482—CONDITIONS OF PARTICIPATION FOR HOSPITALS
Subpart C—Basic Hospital Functions
§ 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.
