[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR483.315]

[Page 539-542]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES--Table of Contents
 
 Subpart F--Requirements That Must be Met by States and State Agencies, 
                           Resident Assessment
 
Sec. 483.315  Specification of resident assessment instrument.


    (a) Statutory basis. Sections 1819(e)(5) and 1919(e)(5) of the Act 
require that a State specify the resident assessment instrument (RAI) to 
be used by long

[[Page 540]]

term care facilities in the State when conducting initial and periodic 
assessments of each resident's functional capacity, in accordance with 
Sec. 483.20.
    (b) State options in specifying an RAI. The RAI that the State 
specifies must be one of the following:
    (1) The instrument designated by CMS.
    (2) An alternate instrument specified by the State and approved by 
CMS, using the criteria specified in the State Operations Manual issued 
by CMS (CMS Pub. 7) which is available for purchase through the National 
Technical Information Service, 5285 Port Royal Rd., Springfield, VA 
22151.
    (c) State requirements in specifying an RAI.
    (1) Within 30 days after CMS notifies the State of the CMS-
designated RAI or changes to it, the State must do one of the following:
    (i) Specify the CMS-designated RAI.
    (ii) Notify CMS of its intent to specify an alternate instrument.
    (2) Within 60 days after receiving CMS approval of an alternate RAI, 
the State must specify the RAI for use by all long term care facilities 
participating in the Medicare and Medicaid programs.
    (3) After specifying an instrument, the State must provide periodic 
educational programs for facility staff to assist with implementation of 
the RAI.
    (4) A State must audit implementation of the RAI through the survey 
process.
    (5) A State must obtain approval from CMS before making any 
modifications to its RAI.
    (6) A State must adopt revisions to the RAI that are specified by 
CMS.
    (d) CMS-designated RAI. The CMS-designated RAI is published in the 
State Operations Manual issued by CMS (CMS Pub. 7), as updated 
periodically, and consists of the following:
    (1) The minimum data set (MDS) and common definitions.
    (2) The resident assessment protocols (RAPs) and triggers that are 
necessary to accurately assess residents, established by CMS.
    (3) The quarterly review, based on a subset of the MDS specified by 
CMS.
    (4) The requirements for use of the RAI that appear at Sec. 483.20.
    (e) Minimum data set (MDS). The MDS includes assessment in the 
following areas:
    (1) Identification and demographic information, which includes 
information to identify the resident and facility, the resident's 
residential history, education, the reason for the assessment, 
guardianship status and information regarding advance directives, and 
information regarding mental health history.
    (2) Customary routine, which includes the resident's lifestyle prior 
to admission to the facility.
    (3) Cognitive patterns, which include memory, decision making, 
consciousness, behavioral measures of delirium, and stability of 
condition.
    (4) Communication, which includes scales for measuring hearing and 
communication skills, information on how the resident expresses himself 
or herself, and stability of communicative ability.
    (5) Vision pattern, which includes a scale for measuring vision and 
vision problems.
    (6) Mood and behavior patterns, which include scales for measuring 
behavioral indicators and symptoms, and stability of condition.
    (7) Psychosocial well-being, which includes the resident's 
interpersonal relationships and adjustment factors.
    (8) Physical functioning and structural problems, which contains 
scales for measuring activities of daily living, mobility, potential for 
improvement, and stability of functioning.
    (9) Continence, which includes assessment scales for bowel and 
bladder incontinence, continence patterns, interventions, and stability 
of continence status.
    (10) Disease diagnoses and health conditions, which includes active 
medical diagnoses, physical problems, pain assessment, and stability of 
condition.
    (11) Dental and nutritional status, which includes information on 
height and weight, nutritional problems and accommodations, oral care 
and problems, and measure of nutritional intake.
    (12) Skin condition, which includes current and historical 
assessment of skin problems, treatments, and information regarding foot 
care.

[[Page 541]]

    (13) Activity pursuit, which gathers information on the resident's 
activity preferences and the amount of time spent participating in 
activities.
    (14) Medications, which contains information on the types and 
numbers of medications the resident receives.
    (15) Special treatments and procedures, which includes measurements 
of therapies, assessment of rehabilitation/restorative care, special 
programs and interventions, and information on hospital visits and 
physician involvement.
    (16) Discharge potential, which assesses the possibility of 
discharging the resident and discharge status.
    (17) Documentation of summary information regarding the additional 
assessment performed through the resident assessment protocols.
    (18) Documentation of participation in assessment.
    (f) Resident assessment protocols (RAPs). At a minimum, the RAPs 
address the following domains:
    (1) Delirium.
    (2) Cognitive loss.
    (3) Visual function.
    (4) Communication.
    (5) ADL functional/rehabilitation potential.
    (6) Urinary incontinence and indwelling catheter.
    (7) Psychosocial well-being.
    (8) Mood state.
    (9) Behavioral symptoms.
    (10) Activities.
    (11) Falls.
    (12) Nutritional status.
    (13) Feeding tubes.
    (14) Dehydration/fluid maintenance.
    (15) Dental care.
    (16) Pressure ulcers.
    (17) Psychotropic drug use.
    (18) Physical restraints.
    (g) Criteria for CMS approval of alternate instrument. To receive 
CMS approval, a State's alternate instrument must use the standardized 
format, organization, item labels and definitions, and instructions 
specified by CMS in the latest issuance of the State Operations Manual 
issued by CMS (CMS Pub. 7).
    (h) State MDS collection and data base requirements. (1) As part of 
facility survey responsibilities, the State must establish and maintain 
an MDS Database, and must do the following:
    (i) Use a system to collect, store, and analyze data that is 
developed or approved by CMS.
    (ii) Obtain CMS approval before modifying any parts of the CMS 
standard system other than those listed in paragraph (h)(2) of this 
section (which may not be modified).
    (iii) Specify to a facility the method of transmission of data to 
the State, and instruct the facility on this method.
    (iv) Upon receipt of data from a facility, edit the data, as 
specified by CMS, and ensure that a facility resolves errors.
    (v) At least monthly, transmit to CMS all edited MDS records 
received during that period, according to formats specified by CMS, and 
correct and retransmit rejected data as needed.
    (vi) Analyze data and generate reports, as specified by CMS.
    (2) The State may not modify any aspect of the standard system that 
pertains to the following:
    (i) Standard approvable RAI criteria specified in the State 
Operations Manual issued by CMS (CMS Pub. 7) (MDS item labels and 
definitions, RAPs and utilization guidelines).
    (ii) Standardized record formats and validation edits specified in 
the State Operations Manual issued by CMS (CMS Pub. 7).
    (iii) Standard facility encoding and transmission methods specified 
in the State Operations Manual issued by CMS (CMS Pub. 7).
    (i) State identification of agency that collects RAI data. The State 
must identify the component agency that collects RAI data, and ensure 
that this agency restricts access to the data except for the following:
    (1) Reports that contain no resident-identifiable data.
    (2) Transmission of data and reports to CMS.
    (3) Transmission of data and reports to the State agency that 
conducts surveys to ensure compliance with Medicare and Medicaid 
participation requirements, for purposes related to this function.
    (4) Transmission of data and reports to the State Medicaid agency 
for purposes directly related to the administration of the State 
Medicaid plan.

[[Page 542]]

    (5) Transmission of data and reports to other entities only when 
authorized as a routine use by CMS.
    (j) Resident-identifiable data. (1) The State may not release 
information that is resident-identifiable to the public.
    (2) The State may not release RAI data that is resident-identifiable 
except in accordance with a written agreement under which the recipient 
agrees to be bound by the restrictions described in paragraph (i) of 
this section.

[62 FR 67212, Dec. 23, 1997]