CMS SOM App. A, Tag A-0406

contained within pre-printed and electronic standing orders, order sets, and protocols for

patient orders only if such orders meet the requirements of §482.24(c)(3).

§482.23(c)(3) - With the exception of influenza and pneumococcal polysaccharide vaccines,

which may be administered per physician-approved hospital policy after an assessment of

contraindications, orders for drugs and biologicals must be documented and signed by a

practitioner who is authorized to write orders in accordance with State law and hospital policy,

and who is responsible for the care of the patient as specified under §482.12(c)…

§482.23(c)(3)(iii) Orders for drugs and biologicals may be documented and signed by other

practitioners not specified under §482.12(c) only if such practitioners are acting in

accordance with State law, including scope of practice laws, hospital policies, and medical

staff bylaws, rules, and regulations.

Interpretive Guidelines §482.23(c)(1) (ii ),(c)(3) and (c)(3)(iii)

All orders for drugs and biologicals, with the exception of influenza and pneumococcal vaccines,

must be documented and signed by a practitioner who is responsible for the care of the patient, as

specified under §482.12(c), or who is another practitioner who is authorized by hospital policy

and medical staff bylaws, rules and regulations, and who is acting in accordance with State law,

including scope of practice laws.

Flu and pneumonia vaccines

Influenza and pneumococcal vaccines may be administered per physician-approved hospital

policy, i.e., hospital policy approved by the physician members of the medical staff. There must

be an assessment of contraindications prior to administration of the vaccine(s). There is no

requirement for authentication by a practitioner when influenza and pneumococcal vaccines are

administered to a patient in accordance with hospital policy and State law.

Standing orders

Nurses or other personnel authorized by hospital policy and in accordance with State law may

administer drugs and biologicals in accordance with pre-printed and electronic standing orders,

order sets, and protocols for patient orders, collectively referred to in this guidance as “standing

orders,” to address well- defined clinical scenarios involving medication administration. The

requirements governing the hospital’s development and use of standing orders are found at the

Medical Records CoP, under §482.24(c)(3). For the nursing services requirement

under§482.23(c)(1) (ii), compliance assessment focuses on whether nurses comply with the

hospital’s established standing orders policies and procedures when administering drugs or

biological in accordance with a standing order.

Survey Procedures §482.23(c)(1) (ii ), (c)(3) and (c)(3)(iii)

• Review the hospital’s policy for drug and biological orders. Does it require that all

administration of drugs or biologicals be based on either an applicable standing order or

the order of a practitioner who is responsible for the care of the patient or otherwise

authorized by hospital and medical staff policy and in accordance with State law to write

orders?

• Interview nursing staff to determine whether they initiate medications in accordance with

standing orders. Are they familiar with the hospital’s policies and procedures for using

standing orders? Are they following the policies and procedures? Ask to see the

protocol for a standing order used by nursing staff, and ask nursing staff to explain how

their practice conforms to the protocol.

• Review a sample of open and closed patient medical records. Although the regulation

applies to both inpatient and outpatient medical records, the sample should be weighted

to include more inpatient records.

• Determine whether all orders for drugs and biologicals, with the exception of influenza

and pneumococcal vaccines, are included in the patient’s medical record and

authenticated by a practitioner who is authorized to write orders by hospital and medical

staff policy and in accordance with State law and who is responsible for the care of the

patient.

• Determine whether all standing orders which were initiated by a nurse were authenticated

by an authorized practitioner.

• Determine whether all orders for drugs and biologicals contain the required elements.