CMS SOM App. J, Tag W124

client's medical condition, developmental and behavioral status, attendant risks of treatment,

and of the right to refuse treatment;

Guidance §483.420(a)(2)

Clients, their families or legal guardians are promptly informed of any change in the client’s

medical or behavioral needs that requires immediate alteration to programmatic or medical

intervention. Promptly is defined by the level of severity of the alteration. In each case, they

must also be informed of the attendant risks of any recommended treatments or interventions

and of their right to refuse treatment, training or services.

If parents or legal guardians wish for other members of the client’s family to be informed of

such changes, they must put this permission in writing.

The communication of this information must be provided in the manner and language

understood by the client or their family or legal guardian (language boards, sign language, etc.).

The term "attendant risks of treatment" describes the risk vs. risk and risk vs. benefit associated

with the treatment. These risks include possible side effects, other complications from

treatments including medical and drug therapy, unintended consequences of treatment, other

behavioral or psychological ramifications arising from treatment, etc.

The facility actively attempts to engage clients who refuse to participate in active treatment.

While the regulation recognizes the client’s right to refuse treatment, persistent refusal that

impacts the health and safety of the client and/or others, or the ability to provide overall active

treatment, may result in facility’s consideration of alternative placements for the client. It is

expected, however, that the facility has assessed the reason for refusal, and developed and

implemented all possible interventions to engage the client in active treatment programs prior

to referring the client to another therapeutic setting.

A client, his or her family member, or legal guardian who refuses a particular treatment (e.g., a

behavior control, seizure control medication or a particular intervention strategy) must be

offered information about acceptable alternatives to the treatment, if acceptable alternatives

are available. The client's preference about alternatives should be elicited and considered in

deciding on the course of treatment. If the client, family member, or legal guardian also refuses

the alternative treatment, or if no alternative exists to the treatment refused, the facility must

consider the effect this refusal may have on other clients, the client himself or herself, and if

they can continue to provide services to the client consistent with these regulations.

If the facility is unable to provide services to a client due to consistent refusal to participate,

they must weigh all options including an involuntary discharge. Involuntary discharge must be

for good cause (see 483.440(b)(4)(i)).

When a client is considered for participation in experimental research the client, his/her family

and/or legal guardian must be fully informed of the nature of the experiment (e.g., what

medications or physical interventions will be utilized, the length of the research, any possible

side effects and how the information from the research will be utilized). Information regarding

the possible consequences of participating or not participating must be provided to the client,

family member or legal guardian. The written consent of the client, his/her family or legal

guardian must be received prior to participation. For a client who is a minor or who has been

adjudicated as incompetent, the written informed consent of the parents of the minor or the

legal guardian is required. The signed, informed consent documentation must be in compliance

with HHS Guidelines for Research Involving Human Subjects. The signed consent must also

include a clear discussion of what treatments will be included in the research, the time limits for

the research and should clearly inform the client, family member or legal guardian that the

client may end participation at any time without fear of recrimination. If the research protocol

indicates that clients receive compensation, then clients are compensated per the protocol.

Any research must be reviewed and approved by the Specially Constituted Committee. See

W263.