CMS SOM App. L, Tag Q-0224

The ASC must comply with the following requirements:

(1) Provide the patient or, as appropriate, the patient’s representative with written

information concerning its policies on advance directives, including a description of

applicable State health and safety laws and, if requested, official State advance directive

forms.

(2) Inform the patient or, as appropriate, the patient’s representative of the patient’s

rights to make informed decisions regarding the patient’s care.

(3) Document in a prominent part of the patient’s current medical record, whether or

not the individual has executed an advance directive.

Interpretive Guidelines: §416.50(c)

Information on Advance Directives

An advance directive is a written instruction, such as a living will or durable power of

attorney for healthcare, recognized under State law (whether statutory or as recognized

by the courts of the State), relating to the provision of healthcare when the individual who

has issued the directive is incapacitated. (See 42 CFR 489.100.)

Each ASC patient has the right to formulate an advance directive consistent with

applicable State law and to have ASC staff implement and comply with the advance

directive, subject to the ASC’s limitations on the basis of conscience. To the degree

permitted by State law, and to the maximum extent practicable, the ASC must respect the

patient’s wishes and follow that process.

The facility must provide the patient or the patient’s representative, as appropriate, the

following information in writing, prior to the start of the surgical procedure:

• Information on the ASC’s policies on advance directives;

• A description of the applicable State health and safety laws. (Note that CMS does

not determine whether this description is accurate. State Survey Agencies are

responsible for making this accuracy determination.); and

• If requested, official State advance directive forms, if such exist.

The ASC must include in the information concerning its advance directive policies a

clear and precise statement of limitation if the ASC cannot implement an advance

directive on the basis of conscience or any other specific reason that is permitted under

State law. A blanket statement of refusal by the ASC to comply with any patient advance

directives is not permissible. However, if and to the extent permitted under State law, the

ASC may decline to implement elements of an advance directive on the basis of

conscience or any other reason permitted under State law if it includes in the information

concerning its advance directive policies a clear and precise statement of limitation. A

statement of limitation must:

• Clarify any differences between ASC-wide conscience objections and those that

may be raised by individual ASC staff;

• Identify the state legal authority permitting such objection; and

• Describe the range of medical conditions and procedures affected by the objection

For example, the ASC’s notice of limitation could, if permitted by State law, indicate that

it would always attempt to resuscitate a patient and transfer that patient to a hospital in

the event of deterioration.

The patient may wish to delegate his/her right to make informed decisions to another

person, even though the patient is not incapacitated. To the extent permitted by State

law, the ASC must respect such delegation. In some cases, the patient may be

unconscious or otherwise incapacitated. If the patient is unable to make a decision, the

ASC must consult the patient’s advance directives, medical power of attorney, or patient

representative or surrogate, if any of these are available. In the advance directive or the

medical power of attorney, the patient may provide guidance as to his or her wishes in

certain situations, or may delegate decision-making to another individual as permitted by

State law. If such an individual has been selected by the patient, or if a person willing

and able under applicable State law is available to make treatment decisions, relevant

information should be provided to the representative or surrogate, so that informed

healthcare decisions can be made for the patient. However, as soon as the patient is able

to be informed of his or her rights, the ASC should also provide that information to the

patient.

The right to make informed decisions presumes that the patient, or the patient’s

representative or surrogate, has been provided information about the patient’s health

status, diagnosis and prognosis. It includes providing consent to the surgical procedure(s)

to be performed in the ASC. The patient, or the patient’s representative or surrogate,

must receive adequate information, provided in a manner that the patient or the patient’s

representative or surrogate can understand, to assure that the patient can effectively

exercise the right to make informed decisions about care in the ASC. In many cases, the

informed consent may take place in a physician office outside the ASC and prior to the

patient’s visit to the ASC. Nevertheless, the ASC is responsible for ensuring an informed

process is in place for each patient. (See discussion of fully informing the patient under

§416.50(e)(iii).)

Documentation of Advance Directives

The ASC must document in the patient’s current medical record, i.e., the record for the

current ASC visit, whether or not the patient has executed an advance directive. This

documentation must be placed in a prominent part of the medical record where it will be

readily noticeable by any ASC staff providing clinical services to the patient. The

documentation requirement applies, even if the ASC is unable to comply with the

patient’s advance directive on the basis of conscience or a State law limitation.

If the patient with an advance directive is transferred from the ASC to another healthcare

facility, e.g., if there is an emergency transfer to a hospital, the ASC must ensure that a

copy of the patient’s advance directive is provided with the medical record when the

patient is transferred.

The ASC should provide education to its staff concerning the facility’s policies and

procedures on advance directives.

Survey Procedures: §416.50(c)

• Review the ASC’s policies and procedures related to the advance directive

requirements. Do they conform to the regulatory requirements?

• Ask to see a copy of the written notice of the ASC’s advance directive policies

and applicable State law. Does it contain all required information? If there is a

statement of limitations based on conscience or State law, does it include all

required information?

• If the State has an official advance directive form, ask the ASC to demonstrate

how it provides these forms upon request to patients.

• Ask the ASC how it documents that required advance directive information is

provided to the patient prior to the start of the surgical procedure. Review each

record in the survey sample to determine if there is evidence that the information

was provided to the patient or the patient’s representative prior to the start of the

surgical procedure.

• Review each record in the survey sample to determine if advance directive

information was provided prior to the start of the surgical procedure.

• Does the ASC advise patients, or the patient’s representative or surrogate, of their

right to make informed decisions about their care in the ASC?

• Review each record in the survey sample to determine if information is

prominently displayed as to whether or not there is an advance directive in effect

for the patient. Is the information displayed in a manner such that patients with

advance directives can be readily distinguished from patients without an advance

directive?

• Determine to what extent the ASC educates its staff regarding advance directives

and promoting informed decisions. Does the ASC have a training class or any

educational materials available for the staff regarding advance directives and

informed patient decision-making? Interview staff to determine their knowledge

of the advance directives of the patients in their care.