Guideline text:
(Rev. 95, Issued: 12-12-13, Effective: 06-07-13, Implementation: 06-07-13)

§482.23(c)(1) (ii)- Drugs and biologicals may be prepared and administered on the orders 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.

Structured rule (JSON):
{"intent_tags": ["safety", "quality", "compliance"], "logic_config": {"required_artifact": "documented and signed order by an authorized practitioner", "trigger_assertion": "administration of a drug or biological (excluding influenza and pneumococcal vaccines)"}, "rule_type": "conditional_existence", "scope_tags": ["clinical", "facility", "legal"]}