CMS SOM App. A, Tag A-0457

protocols for patient orders only if the hospital:

(i) Establishes that such orders and protocols have been reviewed and approved by the

medical staff and the hospital’s nursing and pharmacy leadership;

(ii) Demonstrates that such orders and protocols are consistent with nationally recognized

and evidence-based guidelines;

(iii) Ensures that the periodic and regular review of such orders and protocols is conducted

by the medical staff and the hospital’s nursing and pharmacy leadership to determine the

continuing usefulness and safety of the orders and protocols; and

(iv) Ensures that such orders and protocols are dated, timed, and authenticated promptly in

the patient’s medical record by the ordering practitioner or another practitioner responsible for

the care of the patient only if such a practitioner is acting in accordance with State law, including

scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.

Interpretive Guidelines §482.24(c)(3)

What is covered by this regulation?

There is no standard definition of a “standing order” in the hospital community at large (77 FR

29055, May 16, 2012), but the terms “pre-printed standing orders,” “electronic standing orders,”

“order sets,” and “protocols for patient orders” are various ways in which the term “standing

orders” has been applied. For purposes of brevity, in our guidance we generally use the term

“standing order(s)” to refer interchangeably to pre-printed and electronic standing orders, order

sets, and protocols. However, we note that the lack of a standard definition for these terms and

their interchangeable and indistinct use by hospitals and health care professionals may result in

confusion regarding what is or is not subject to the requirements of §482.24(c)(3), particularly

with respect to “order sets.”

• Not all pre-printed and electronic order sets are considered a type of “standing order”

covered by this regulation. Where the order sets consist solely of menus of treatment or care

options designed to facilitate the creation of a patient-specific set of orders by a physician or

other qualified practitioner authorized to write orders, and none of the treatment choices and

actions can be initiated by non-practitioner clinical staff before the physician or other

qualified practitioner actually creates the patient-specific order(s), such menus would not be

considered “standing orders” covered by this regulation. We note in such cases the menus

provide a convenient and efficient method for the physician/practitioner to create an order,

but the availability of such menu options does not create an “order set” that is a “standing

order” subject to the requirements of this regulation. The physician/practitioner may, based

on his/her professional judgment, choose to: use the available menu options to create an

order; not use the menu options and instead create an order from scratch; or modify the

available menu options to create the order. In each case the physician/practitioner exercises

his privileges to prescribe specific diagnosis and/or treatment activities that are to be

implemented for a patient.

• On the other hand, in cases where hospital policy permits treatment to be initiated, by a

nurse, for example, without a prior specific order from the treating physician/practitioner,

this policy and practice must meet the requirements of this regulation for review of standing

orders, regardless of whether it is called a standing order, a protocol, an order set, or

something else. Such treatment is typically initiated when a patient’s condition meets certain

pre-defined clinical criteria. For example, standing orders may be initiated as part of an

emergency response or as part of an evidence-based treatment regimen where it is not

practical for a nurse to obtain either a written, authenticated order or a verbal order from a

physician or other qualified practitioner prior to the provision of care.

• Hybrids, where a component for non-practitioner-initiated treatment is embedded within a

menu of options for the physician or other qualified practitioner, still require compliance with

the requirements for a standing order for that component. For example, if an order set

includes a protocol for nurse-initiated potassium replacement, that protocol must be reviewed

under the requirements of this regulation before it may become part of a menu of treatment

options from which a physician or other qualified practitioner would select treatments for a

particular patient

.

Requirements for “Standing Orders”

Hospitals have the flexibility to use standing orders to expedite the delivery of patient care in

well-defined clinical scenarios for which there is evidence supporting the application of

standardized treatments or interventions.

Appropriate use of standing orders can contribute to patient safety and quality of care by

promoting consistency of care, based on objective evidence, when orders

may be initiated as part of an emergency response or as part of an evidence-based treatment

regimen where it is not practicable for a nurse or other non-practitioner to obtain a verbal or

authenticated written order from a physician or other practitioner responsible for the care of the

patient prior to the provision of care.

In all cases, implementation of a standing order must be medically appropriate for the patient to

whom the order is applied.

Much of the evidence on the effectiveness of standing orders in hospitals has been narrowly

focused on aspects of their use by Rapid Response Teams addressing inpatient emergencies.

However, standing orders may also be appropriate in other clinical circumstances, including, but

not limited to:

• Protocols for triaging and initiating required screening examinations and stabilizing treatment

for emergency department patients presenting with symptoms suggestive of acute asthma,

myocardial infarction, stroke, etc. (This does not relieve a hospital of its obligations under

the Emergency Medical Treatment and Labor Act (EMTALA) to have qualified medical

personnel complete required screening and, when applicable, stabilizing treatment in a timely

manner.)

• Post-operative recovery areas.

• Timely provision of immunizations, such as certain immunizations for newborns, for which

there are clearly established and nationally recognized guidelines.

Standing orders may not be used in clinical situations where they are specifically

prohibited under Federal or State law. For example, the hospital patient’s rights

regulation at §482.13(e)(6) specifically prohibits the use of standing orders for restraint or

seclusion of hospital patients.

When deciding whether to use standing orders, hospitals should also be aware that, although use

of standing orders is permitted under the hospital Conditions of Participation, some insurers,

including Medicare, may not pay for the services provided because of the use of standing orders.

(77 FR 29056)

Minimum requirements for standing orders. Hospitals may employ standing orders only if

the following requirements are met for each standing order for a particular well-defined clinical

scenario:

• Each standing order must be reviewed and approved by the hospital’s medical staff and

nursing and pharmacy leadership before it may be used in the clinical setting. The

regulation requires a multi-disciplinary collaborative effort in establishing the protocols

associated with each standing order.

• The hospital’s policies and procedures for standing orders must address the process by

which a standing order is developed; approved; monitored; initiated by authorized staff;

and subsequently authenticated by physicians or other practitioners responsible for the

care of the patient.

• For each approved standing order, there must be specific criteria clearly identified in the

protocol for the order for a nurse or other authorized personnel to initiate the execution of

a particular standing order, for example, the specific clinical situations, patient

conditions, or diagnoses by which initiation of the order would be justified. Under no

circumstances may a hospital use standing orders in a manner that requires any staff not

authorized to write patient orders to make clinical decisions outside of their scope of

practice in order to initiate such orders.

Since residents are physicians, this regulation does not require specific criteria for a

resident to initiate the execution of a particular standing order. However, there may be

State laws governing the practice of residents in hospitals that are more restrictive; if so,

the hospital is expected to comply with the State law. Likewise, the hospital may choose

through its policies and medical staff bylaws, rules and regulations to restrict the role of

residents with respect to standing orders.

• Policies and procedures should also address the instructions that the medical, nursing, and

other applicable professional staff receive on the conditions and criteria for using

standing orders as well as any individual staff responsibilities associated with the

initiation and execution of standing orders. An order that has been initiated for a specific

patient must be added to the patient’s medical record at the time of initiation, or as soon

as possible thereafter.

• Likewise, standing order policies and procedures must specify the process whereby the

physician or other practitioner responsible for the care of the patient acknowledges and

authenticates the initiation of all standing orders after the fact, with the exception of

influenza and pneumococcal vaccines, which do not require such authentication in

accordance with § 482.23(c)(2).

(76 FR 65896, October 24, 2011 & 77 FR 29056, May 16, 2012)

• The hospital must be able to document that the standing order is consistent with nationally

recognized and evidence-based guidelines. This does not mean that there must be a template

standing order available in national guidelines which the hospital copies, but rather that the

content of each standing order in the hospital must be consistent with nationally recognized,

evidence-based guidelines for providing care. The burden of proof is on the hospital to show

that there is a sound basis for the standing order.

• Each standing order must be subject to periodic and regular review by the medical staff and

the hospital’s nursing and pharmacy leadership, to determine the continuing usefulness and

safety of the orders and protocols. At a minimum, an annual review of each standing order

would satisfy this requirement. However, the hospital’s policies and procedures must also

address a process for the identification and timely completion of any requisite updates,

corrections, modifications, or revisions based on changes in nationally recognized, evidence-based guidelines. The review may be prepared by the hospital’s QAPI program, so long as

the medical staff and nursing and pharmacy leadership read, review, and, as applicable, act

upon the final report. Among other things, reviews are expected to consider:

• Whether the standing order’s protocol continues to be consistent with the latest standards

of practice reflected in nationally recognized, evidence-based guidelines;

• Whether there have been any preventable adverse patient events resulting from the use of

the standing order, and if so, whether changes in the order would reduce the likelihood of

future similar adverse events. Note that the review would not be expected to address

adverse events that are a likely outcome of the course of patient’s disease or injury, even

if the order was applied to that patient, unless there is concern that use of the standing

order exacerbated the patient’s condition; and

• Whether a standing order has been initiated and executed in a manner consistent with the

order’s protocol, and if not, whether the protocol needs revision and/or staff need more

training in the correct procedures.

• An order that has been initiated for a specific patient must be added to the patient’s medical

record at the time of initiation, or as soon as possible thereafter.

The hospital must ensure

each standing order that has been executed is dated, timed, and authenticated promptly in the

patient’s medical record by the ordering practitioner or another practitioner responsible for

the care of the patient. Another practitioner who is responsible for the care of the patient

may date, time and authenticate the standing order instead of the ordering practitioner, but

only if the other practitioner is acting in accordance with State law, including scope of

practice laws, hospital policies, and medical staff bylaws, rules and regulations.

The hospital’s standing orders policies and procedures must specify the process whereby the

responsible practitioner, or another authorized practitioner, acknowledges and authenticates

the initiation of each standing order after the fact, with the exception of standing orders for

influenza and pneumococcal vaccines, which do not require such authentication. Further, the

responsible practitioner must be able to modify, cancel, void or decline to authenticate orders

that were not medically necessary in a particular situation. The medical record must reflect

the physician’s actions to modify, cancel, void or refusal to authenticate a standing order that

the physician determined was not medically necessary. (76 FR 65896, October 24, 2011)

Survey Procedures §482.24(c)(3)

• Ask the hospital’s medical staff and its nursing and pharmacy leadership whether

standing orders are used. If yes, ask them to describe how a standing order is developed

and monitored, and their role in the process.

• Ask to see an example of one or more standing orders, including documentation on the

development of the order, including:

• Reference to the evidence-based national guidelines that support it;

• Participation of medical staff and nursing and pharmacy leadership in the review

and approval of the standing order;

• Description of the protocol to be followed when initiating the execution of the

order, including description of the roles and responsibilities of various types of

staff;

• Description of the process for authenticating the order’s initiation by the

practitioner responsible for the care of the patient, or another authorized

practitioner;

• Evidence of training of personnel on the order’s protocol; and

• Evidence of periodic evaluation and, if needed, modification of the standing

order, including whether the order remains consistent with current evidence-based

national guidelines, staff adherence to the protocol for initiation and execution,

and whether there have been any preventable adverse events associated with the

order.

• Ask staff providing clinical services in areas of the hospital where standing orders might

be typically used, including but not limited to, the emergency department, labor and

delivery units, and inpatient units, whether standing orders are used. If they say yes, ask

them:

o To describe a typical scenario where a standing order would be used, and what

they would do in that case.

o For a copy of the protocol for that standing order. Does their description conform

to the protocol?

• Review a sample of medical records of patients where a nurse-initiated standing order

was used and verify that the order was documented and authenticated by a practitioner

responsible for the care of the patient.