[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR418.100]



[Page 923-926]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             HUMAN SERVICES

 

PART 418_HOSPICE CARE--Table of Contents

 

          Subpart E_Conditions of Participation: Other Services

 

Sec. 418.100  Condition of participation Hospices that provide inpatient 

care directly.



    A hospice that provides inpatient care directly must comply with all 

of the following standards.

    (a) Standard: Twenty-four-hour nursing services. (1) The facility 

provides 24-hour nursing services which are sufficient to meet total 

nursing needs and which are in accordance with the patient plan of care. 

Each patient receives treatments, medications, and diet as prescribed, 

and is kept comfortable, clean, well-groomed, and protected from 

accident, injury, and infection.

    (2) Each shift must include a registered nurse who provides direct 

patient care.

    (b) Standard: Disaster preparedness. The hospice has an acceptable 

written plan, periodically rehearsed with staff, with procedures to be 

followed in the event of an internal or external disaster and for the 

care of casualties (patients and personnel) arising from such disasters.

    (c) Standard: Health and safety laws. The hospice must meet all 

Federal, State, and local laws, regulations, and codes pertaining to 

health and safety, such as provisions regulating--

    (1) Construction, maintenance, and equipment for the hospice;

    (2) Sanitation;

    (3) Communicable and reportable diseases; and

    (4) Post mortem procedures.

    (d) Standard: Fire protection. (1) Except as otherwise provided in 

this section--

    (i) The hospice must meet the provisions applicable to nursing homes 

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 [reg] 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.html. Copies may be obtained from the 

National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 

02269. If any changes in



[[Page 924]]



this edition of the Code are incorporated by reference, CMS will publish 

notice in the Federal Register to announce the changes.

    (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition 

of the LSC does not apply to a hospice.

    (2) In consideration of a recommendation by the State survey agency, 

CMS may waive, for periods deemed appropriate, specific provisions of 

the Life Safety Code which, if rigidly applied would result in 

unreasonable hardship for the hospice, but only if the waiver would not 

adversely affect the health and safety of the patients.

    (3) The provisions of the adopted edition of the Life Safety Code do 

not apply in a State if CMS finds that a fire and safety code imposed by 

State law adequately protects patients in hospices.

    (4) Beginning March 13, 2006, a hospice must be in compliance with 

Chapter 9.2.9, Emergency Lighting.

    (5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 

does not apply to hospices.

    (6) Notwithstanding any provisions of the 2000 edition of the Life 

Safety Code to the contrary, a hospice may place 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 

Federal Register to announce the changes.

    (e) Standard: Patient areas. (1) The hospice must design and equip 

areas for the comfort and privacy of each patient and family members.

    (2) The hospice must have--

    (i) Physical space for private patient/family visiting;

    (ii) Accommodations for family members to remain with the patient 

throughout the night;

    (iii) Accommodations for family privacy after a patient's death; and

    (iv) Decor which is homelike in design and function.

    (3) Patients must be permitted to receive visitors at any hour, 

including small children.

    (f) Standard: Patient rooms and toilet facilities. Patient rooms are 

designed and equipped for adequate nursing care and the comfort and 

privacy of patients.

    (1) Each patient's room must--

    (i) Be equipped with or conveniently located near toilet and bathing 

facilities;

    (ii) Be at or above grade level;

    (iii) Contain a suitable bed for each patient and other appropriate 

furniture;

    (iv) Have closet space that provides security and privacy for 

clothing and personal belongings;

    (v) Contain no more than four beds;

    (vi) Measure at least 100 square feet for a single patient room or 

80 square feet for each patient for a multipatient room; and

    (vii) Be equipped with a device for calling the staff member on 

duty.

    (2) For an existing building, CMS may waive the space and occupancy 

requirements of paragraphs (f)(1) (v) and (vi) of this section for as 

long as it is considered appropriate if it finds that--



[[Page 925]]



    (i) The requirements would result in unreasonable hardship on the 

hospice if strictly enforced; and

    (ii) The waiver serves the particular needs of the patients and does 

not adversely affect their health and safety.

    (g) Standard: Bathroom facilities. The hospice must--

    (1) Provide an adequate supply of hot water at all times for patient 

use; and

    (2) Have plumbing fixtures with control valves that automatically 

regulate the temperature of the hot water used by patients.

    (h) Standard: Linen. The hospice has available at all times a 

quantity of linen essential for proper care and comfort of patients. 

Linens are handled, stored, processed, and transported in such a manner 

as to prevent the spread of infection.

    (i) Standard: Isolation areas. The hospice must make provision for 

isolating patients with infectious diseases.

    (j) Standard: Meal service, menu planning, and supervision. The 

hospice must--

    (1) Serve at least three meals or their equivalent each day at 

regular times, with not more than 14 hours between a substantial evening 

meal and breakfast;

    (2) Procure, store, prepare, distribute, and serve all food under 

sanitary conditions;

    (3) Have a staff member trained or experienced in food management or 

nutrition who is responsible for--

    (i) Planning menus that meet the nutritional needs of each patient, 

following the orders of the patient's physician and, to the extent 

medically possible, the recommended dietary allowances of the Food and 

Nutrition Board of the National Research Council, National Academy of 

Sciences (Recommended Dietary Allowances (9th ed., 1981) is available 

from the Printing and Publications Office, National Academy of Sciences, 

Washington, DC 20418); and

    (ii) Supervising the meal preparation and service to ensure that the 

menu plan is followed; and

    (4) If the hospice has patients who require medically prescribed 

special diets, have the menus for those patients planned by a 

professionally qualified dietitian and supervise the preparation and 

serving of meals to ensure that the patient accepts the special diet.

    (k) Standard: Pharmaceutical services. The hospice provides 

appropriate methods and procedures for the dispensing and administering 

of drugs and biologicals. Whether drugs and biologicals are obtained 

from community or institutional pharmacists or stocked by the facility, 

the facility is responsible for drugs and biologicals for its patients, 

insofar as they are covered under the program and for ensuring that 

pharmaceutical services are provided in accordance with accepted 

professional principles and appropriate Federal, State, and local laws. 

(See Sec. 405.1124(g), (h), and (i) of this chapter.)

    (1) Licensed pharmacist. The hospice must--

    (i) Employ a licensed pharmacist; or

    (ii) Have a formal agreement with a licensed pharmacist to advise 

the hospice on ordering, storage, administration, disposal, and 

recordkeeping of drugs and biologicals.

    (2) Orders for medications. (i) A physician must order all 

medications for the patient.

    (ii) If the medication order is verbal--

    (A) The physician must give it only to a licensed nurse, pharmacist, 

or another physician; and

    (B) The individual receiving the order must record and sign it 

immediately and have the prescribing physician sign it in a manner 

consistent with good medical practice.

    (3) Administering medications. Medications are administered only by 

one of the following individuals:

    (i) A licensed nurse or physician.

    (ii) An employee who has completed a State-approved training program 

in medication administration.

    (iii) The patient if his or her attending physician has approved.

    (4) Control and accountability. The pharmaceutical service has 

procedures for control and accountability of all drugs and biologicals 

throughout the facility. Drugs are dispensed in compliance with Federal 

and State laws. Records of receipt and disposition of all controlled 

drugs are maintained in sufficient detail to enable an accurate 

reconciliation. The pharmacist determines that drug records are in order



[[Page 926]]



and that an account of all controlled drugs is maintained and 

reconciled.

    (5) Labeling of drugs and biologicals. The labeling of drugs and 

biologicals is based on currently accepted professional principles, and 

includes the appropriate accessory and cautionary instructions, as well 

as the expiration date when applicable.

    (6) Storage. In accordance with State and Federal laws, all drugs 

and biologicals are stored in locked compartments under proper 

temperature controls and only authorized personnel have access to the 

keys. Separately locked compartments are provided for storage of 

controlled drugs listed in Schedule II of the Comprehensive Drug Abuse 

Prevention & Control Act of 1970 and other drugs subject to abuse, 

except under single unit package drug distribution systems in which the 

quantity stored is minimal and a missing dose can be readily detected. 

An emergency medication kit is kept readily available.

    (7) Drug disposal. Controlled drugs no longer needed by the patient 

are disposed of in compliance with State requirements. In the absence of 

State requirements, the pharmacist and a registered nurse dispose of the 

drugs and prepare a record of the disposal.



[48 FR 56026, Dec. 16, 1983; 48 FR 57282, Dec. 29, 1983; 49 FR 23010, 

June 1, 1984, as amended at 53 FR 11509, Apr. 7, 1988; 55 FR 50835, Dec. 

11, 1990; 68 FR 1386, Jan. 10, 2003; 69 FR 18803, Apr. 9, 2004; 69 FR 

49266, Aug. 11, 2004; 70 FR 15237, Mar. 25, 2005]