STATEMENTS OF POLICY
Title 49—PROFESSIONAL AND VOCATIONAL STANDARDS
STATE BOARD OF NURSING
[49 PA. CODE CH. 21]
Interpretations Regarding the Administration of Drugs—Statement of Policy
[53 Pa.B. 1806]
[Saturday, April 1, 2023]The State Board of Nursing (Board) amends § 21.413(d) (relating to interpretations regarding the administration of drugs—statement of policy) to read as set forth in Annex A. This statement of policy is intended to provide guidance to Board-regulated practitioners, other healthcare providers, health and hospital systems and the general public.
Statutory Authority
Sections 8.2(c) and 8.3(b) of the Professional Nursing Law (RN Law) (63 P.S. §§ 218.2(c) and 218.3(b)) authorize certified registered nurse practitioners (CRNP) who meet the requirements of section 8.3(a) of the RN Law to prescribe medical therapeutic or corrective measures within the terms of the collaborative agreement. Section 21.401(d) (relating to interpretations: scope of practice) delineates the procedure for adopting a statement of policy, including publication of a notice and review indicating the date and place for the conduct of hearings and consideration of public comments received following publication of the notice.
Background and Purpose
Under section 8.2 of the RN Law, CRNPs are required to practice within the scope of practice of the particular clinical specialty area in which the nurse is certified by the Board and within the terms of their collaborating agreements. In 1998, when § 21.413(d) was last amended, CRNPs had not yet been granted the authority under the RN Law to prescribe. Since that time, sections 8.2(c) and 8.3(b) of the RN Law were added authorizing CRNPs who possess prescriptive authority to prescribe medical therapeutic or corrective measures. Because the administration of conscious sedation under § 21.284(b)(7) (relating to prescribing and dispensing parameters) is within a CRNP's authority to prescribe, the Board updates § 21.413(d) to reflect the changes in the RN Law. This amendment provides that CRNPs may order conscious sedation medications. Additionally, the Board clarifies that either a physician or a CRNP must be physically present in the room during administration.
Under § 21.401(a), the Board may, upon request of a licensed nurse, nursing association, health care facility or licensed health care professional, issue interpretations of Chapter 21 (relating to State Board of Nursing) as they apply to the question of whether the execution of specific practices are within the scope of professional or practical nursing. On December 28, 2018, the Pennsylvania Coalition of Nurse Practitioners (PCNP) requested that the Board modernize § 21.413(d)(1). It maintained that at times, in both inpatient (acute) and ambulatory (outpatient) settings, the CRNP may be the primary care provider for the patient or may be the only health care provider present, or both, especially overnight. Waiting for a physician to order the medications or be physically present for their administration creates unnecessary delays, for example, when a patient is in respiratory distress and needs to be intubated but no physician is present to order or view the administration or in cases where only CRNPs and physician assistants are manning intensive care units or emergency rooms.
The proposed interpretation is consistent with the Department of Health's regulations in 28 Pa. Code §§ 107.61, 107.62, 107.64, 107.65, 109.23, 109.61 and 211.7.
Although not required for the promulgation of a statement of policy, the Board sent an exposure draft to its' stakeholders on August 9, 2019. The Board received comments from nursing programs, nurses and associations representing nursing, medicine and healthcare. Except for one commentator who asked questions and one who opposed the proposal, all other commentators voiced their support for the proposal. At its December 5, 2019, meeting, the Board discussed the pre-draft comments with representatives from PCNP and the Pennsylvania Medical Society (PAMED) and voted to proceed with publishing the notice of intent to amend the statement of policy.
Notice of the statement of policy was published at 52 Pa.B. 3679 (July 2, 2022), under § 21.401(d). Included within the notice was the Board's advisement that it would entertain public comment until August 31, 2022, and would hold a hearing on the proposal on October 28, 2022. The Board received one comment, on July 13, 2022, from a CRNP and representative of Penn Medicine, who was also the sole commenter at the hearing. The commenter requested that the Board delete the term ''intravenous'' in § 21.413(d) and (d)(1) because conscious sedation can be administered intravenously, nasally, orally, intramuscularly and by inhalation. In addition, the commenter recommended that the Board delete the clause ''within the terms of their collaborative agreement'' in § 21.413(d)(1) on the grounds that it is ''redundant and unnecessary'' since section 8.2 of the RN Law requires that CRNPs practice within the terms of their collaborative agreements. The Board concurred with the recommended amendments and adopted this statement of policy at its October 28, 2022, meeting. Because the deletion of the term ''intravenous'' in § 21.413(d) and (d)(1) required additional amendments to (d)(2), (4), (6) and (7), the Board voted to approve the additional amendments to § 21.413(d) at its meeting on December 15, 2022.
Description of the Statement of Policy
This statement of policy clarifies that registered nurses may administer a specific amount of conscious sedation medication during minor therapeutic and diagnostic procedures upon a written order of either a physician or a CRNP when either a physician or CRNP is present during the administration. This statement of policy is expected to eliminate confusion about CRNPs' authority to order and supervise registered nurses' (RN) administration of conscious sedation under the circumstances outlined in subsection (d).
Subsection (d) provides guidance as to the circumstances under which an RN, who is not a certified registered nurse anesthetist, may administer a specific amount of conscious sedation medication during minor therapeutic and diagnostic procedures. Specifically, paragraph (1) identifies who provides the order and who must be present when the administration is given; paragraph (2) requires written guidelines; paragraph (3) specifies the monitoring equipment required; paragraph (4) identifies requirements for intravenous access; paragraph (5) addresses ACLS certification; paragraph (6) addresses the education required; paragraph (7) outlines concurrent responsibilities for the nurse administering the anesthesia; and paragraph (8) describes the length of monitoring.
In paragraph (1), this statement of policy clarifies that either a physician or a CRNP may order conscious sedation and either a physician or a CRNP must be present when the service is provided. It does not require that the same practitioner who ordered the conscious sedation be present when it is administered by the RN. Although the Board included PAMED's suggestion that the clause ''within the terms of their collaborative agreement'' modify ''certified registered nurse practitioner'' in the notice of its intent to amend paragraph (1), upon further discussion at the December 2022 meeting, the Board agrees that this addition is unnecessary as sections 8.2(b) and 8.3(a)(2) of the RN Law and §§ 21.282a, 21.283, 21.285(a)(1) and 21.288 govern the terms of a CRNP's practice. The statutory and regulatory provisions require a CRNP to always practice in accordance with the written agreement between the CRNP and the collaborating physician. Thus, including this clause in paragraph (1) is unnecessary and redundant.
With regard to the recommendation that the Board delete all references to ''intravenous'' in subsection (d), the Board agrees and therefore, deletes the term ''intravenous'' from paragraphs (1), (2), (6) and (7) as these provisions apply to all of the previously listed administration methods. Nonetheless, because paragraph (4) specifically addresses intravenous administration, the Board retains the term ''intravenous'' and adds ''when the conscious sedation is administered intravenously'' to the end of that paragraph.
Fiscal Impact and Paperwork Requirements
This statement of policy will have no adverse fiscal impact on the Commonwealth or its political subdivisions and will impose no additional paperwork requirements upon the Commonwealth, political subdivisions or the private sector.
Sunset Date
A sunset date is not being established for this statement of policy. Its need and efficacy will be periodically monitored by the Board.
Effective Date
This statement of policy will be effective upon publication in the Pennsylvania Bulletin.
Additional Information
Persons who require additional information about the statement of policy may submit inquiries to the Counsel, State Board of Nursing, P.O. Box 2649, Harrisburg, PA 17105-2649, (717) 783-7200, or RA-STRegulatoryCounsel@ pa.gov.
LINDA L. KMETZ, PhD, RN,
Chairperson(Editor's Note: Title 49 of the Pennsylvania Code is amended by amending the statement of policy in § 21.413 to read as set forth in Annex A.)
Fiscal Note: Fiscal Note 16A-5144 remains valid for the final adoption of the subject regulation.
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 21. STATE BOARD OF NURSING
Subchapter D. INTERPRETATIONS
STATEMENT OF POLICY § 21.413. Interpretations regarding the administration of drugs—statement of policy.
* * * * * (d) As used in this subsection, ''conscious sedation'' is defined as a minimally depressed level of consciousness in which the patient retains the ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal commands. The registered nurse who is not a certified registered nurse anesthetist may administer conscious sedation medications, under § 21.14, during minor therapeutic and diagnostic procedures, when the following conditions exist:
(1) The specific amount of conscious sedation medications has been ordered in writing by a licensed physician or certified registered nurse practitioner and a licensed physician or certified registered nurse practitioner is physically present in the room during administration.
(2) Written guidelines specifying the medications that the registered nurse may administer in a particular setting are available to the registered nurse.
(3) Electrocardiogram, blood pressure and oximetry equipment are used for both monitoring and emergency resuscitation purposes pursuant to written guidelines which are provided for minimum patient monitoring. Additional emergency resuscitation equipment is immediately available.
(4) The patient has a patent intravenous access when the conscious sedation is administered intravenously.
(5) The registered nurse involved in direct patient care is certified in advanced cardiac life support (ACLS). Provisions shall be in place for back-up personnel who are experts in airway management, emergency intubation and advanced life support if complications arise.
(6) The registered nurse possesses the knowledge, skills and abilities related to the management of patients receiving conscious sedation with evaluation of competence on a periodic basis. This includes, but is not limited to, arrhythmia detection, airway management and pharmacologic action of drugs administered. This includes emergency drugs.
(7) The registered nurse managing the care of the patient receiving conscious sedation medication may not have other responsibilities during the procedure. The registered nurse may not leave the patient unattended or engage in tasks which would compromise continuous monitoring.
(8) The registered nurse monitors the patient until the patient is discharged by a qualified professional authorized to discharge the patient in accordance with established criteria of the facility.
[Pa.B. Doc. No. 23-428. Filed for public inspection March 31, 2023, 9:00 a.m.]
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