BOARD OF REGISTERED NURSING PO Box 944210, Sacramento, CA 94244-2100 P (916) 322-3350 F (916) 574-8637 | www.rn.ca.gov

BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY • GOVERNOR EDMUND G. BROWN JR.

NURSING PRACTICE

COMMITTEE MEETING

Board of Registered Nursing – Hearing Room 1747 North Market Blvd. Sacramento, CA 95841

(916) 574-7600

AGENDA

March 8, 2017

THIS MEETING WILL IMMEDIATELY FOLLOW THE CONCLUSION OF THE INTERVENTION/DISCIPLINE COMMITTEE MEETING

Wednesday, March 8, 2017

10.0 Call to Order/Roll Call /Establishment of a Quorum 10.0.1 Review and Vote on Whether to Approve Previous Meeting’s Minutes:

January 11, 2017 10.1 Update on Rulemaking for Article 8 Standards for Nurse Practitioners; Discussion and

Possible Action to Approve Proposed Responses to the Comments Received from the 15-day Comment Period

10.2 Information Only: Epinephrine Auto Injectors: “Authorized Entity” 10.3 Information Only: Pupil Health: Naloxone Hydrochloride, and other Opioid Antagonist 10.4 Discussion and Possible Recommendation for the Board to Create Advanced Practice

committee 10.5 Public Comment for Items Not on the Agenda 10.6 Adjournment

NOTICE: All times are approximate. Meetings may be canceled without notice. For verification of meeting, call (916) 574-7600 or access the Board’s Web Site www.rn.ca.gov under “Meetings.” The meeting is accessible to the physically disabled. A person who needs a disability-related accommodation or modification in order to participate in the meeting may make a request by contacting the Administration Unit at (916) 574-7600 or email webmasterbrn@dca.ca.gov or send a written request to the Board of Registered Nursing Office at 1747 North Market Suite 150, Sacramento, CA 95834. (Hearing impaired: California Relay Service: TDD phone (800) 326-2297). Providing your request at least five (5) business days before the meeting will help to ensure the availability of the requested accommodation. Board members who are not members of this committee may attend meetings as observers only, and may not participate or vote. Action may be taken on any item listed on this agenda, including information only items. Items may be taken out of order for convenience, to accommodate speakers, or maintain a quorum. The public will be provided an opportunity to comment on each agenda item at the time it is discussed; however, the committee may limit the time allowed to each speaker.

BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY • GOVERNOR EDMUND G. BROWN JR.

BOARD OF REGISTERED NURSING PO Box 944210, SACRAMENTO, CA 94244-2100 P (916) 322-3350 F (916) 574-8637 www.rn.ca.gov

BOARD OF REGISTERED NURSING NURSING PRACTICE COMMITTEE MINUTES

January 11, 2017

Embassy Suites-Anaheim South

11767 Harbor Blvd. Garden Grove, CA 92840

(714) 539-3300

MEMBERS PRESENT Michael Jackson, MSN, BSN, RN, CEN, MICN Cynthia Klein, RN Elizabeth Woods, RN

MEMBER(S) NOT PRESENT Trande Phillips, RN STAFF PRESENT: Janette Wackerly, MBA, BSN, RN, SNEC, Staff Liaison January 11, 2017 Meeting called to order by Michael Jackson, RN Chair at 12:45 PM Member introductions: Michael Jackson RN, Cynthia Klein, RN, Elizabeth Woods, RN 10.0 Review and Vote on Whether to Approve Previous Meeting Minutes January 11, 2016

Motion: Michael Jackson

Second: Elizabeth Woods TP: absent CK: yes MJ: yes

EW: yes

10.1 Update on Rulemaking for Article 8 Standards for Nurse Practitioners; Vote on Recommendation

to Continue the Regulatory Process

Motion: Michael Jackson move agenda item to Board meeting Second: Elizabeth Woods TP: absent CK: yes MJ: yes EW: yes

The regulatory proposal amending Article 8 Nurse Practitioners §1480-1485 and to add section 1483.1 Requirements for Nurse Practitioner Education Programs in California, 1483.2 Requirements for Reporting Nurse Practitioner Education Programs, 1486 Requirements for Clinical Practice Experience for Nurse Practitioner Students Enrolled in Out of State Nurse Practitioner Education Program. There was no public testimony at the hearing on September 19th, 2016. During the comment period four organizations submitted comments. As a result of the submitted comments, the Board issued Modified Text to the proposed regulations. The Modified Text comment period was from November 21, 2016 to December 7, 2016. The Modified Text that was noticed on November 21, 2016, is attached and includes both the initial and modified language. The initial changes are designated by single underline and single strikeout and the modified language is designated by red double underline and red double strikeout. The following is the summary of the comments and proposed responses from the Modified Text comment period. UC Irvine Program in Nursing Science, California Action Coalition a HealthImpact program; California Nursing Students’ Association, American Nurses Association California, California Association of Nurse Anesthetists, Association of California Nurse Leaders, California Association of Clinical Nurse Specialists, Western University, California Association of Colleges of Nursing, California Association for Nurse Practitioners and California Nurse-Midwives .strongly supports the regulatory language and intent to require lead faculty and director of a nurse practitioner education program to be certified by a national organization. The following are letters from respondents are attached University of California, Irvine – Alison Holman, Ph.D., RN, FNP Interim Director, UC Irvine Program in Nursing Science California Action Coalition- Garrett Chan, Ph.D., NP, CNS, ACNP-C, CNS-BC, Susanne Phillips, DNP, NP, FNP_BC California Nursing Students Association- Patricia McFarland, MS, RN, FAAN, CEO American Nurses Association California- Marketa Houskova, RN, MAIA, BA Interim State Government Affairs Director, Director Senior Policy Analyst California Association of Nurse Anesthetists, Inc.- Marciel Reighard, DNAP, CRNA CANA President Association of California Nurse Leaders- Patricia McFarland, MS, RN, FAAN, CEO California Association of Clinical Nurse Specialist- Lianna Z. Ansryan, RN-BC, CNS, MSN President Western University of Health Sciences- Diana Lithgow, Ph.D., FNP, RN-BC Professor of Nursing, Director FNP Program, Director Ambulatory Care Program, Assistant Dean of Distance Operations California Association of Colleges of Nursing- Philip A. Greiner, DNSc, RN President California Association for Nurse Practitioners- Theresa Ullrich, MSN, FNP-C President

California Nurse-Midwives Association- Kim Q. Dau, CNM Chair, Health Policy Committee

10.2 Discussion and Possible Recommendation to Create Advanced Practice Subcommittee

Motion: Michael Jackson move agenda to next Board meeting

Second: Elizabeth Woods TP: absent CK: yes MJ: yes EW: yes

The purpose of the advanced practice subcommittee is to provide recommendations to the Board on issues involving nursing advanced practice. The advanced practice registered nurses are nurse practitioner, nurse anesthetist, nurse-midwives and clinical nurse specialist. The goals of the advanced practice subcommittee:

1. Clarify and articulate sufficiency of the four advanced practice roles and recommend changes to the Nursing Practice Act and rules

2. Develop recommendations for joint statements related to scope of practice and advanced practice nurse functions

3. Review national trends in the regulation of advance practice nurses and make recommendations to the board.

4. Collaborate with other Board committees on matters of mutual interest Suggestion for committee members to include 2 board members, 2 BRN staff, 4 NPs, 2 CRNA, 2 CNS, and 2 CNM Suggestion for committee meetings to be held semi-annually in Sacramento. 10.3 Information and Discussion: Memorandum of Understanding (MOU), with relevant state

agencies or partner agencies to share data; Possible Recommendation

Motion: no motion information only

Second: TP: CK: MJ: EW:

The State Auditor Report 2016-046, was publicly released in December 2016 is one of the recommendations, to ensure that it has prompt access to adequate information that could affect the status of a nurse’s license, BRN should do the following by June 2017.

Establish formal agreements with other agencies and other health boards that have information pertaining to a nurse’s misconduct.

Work with Consumer Affairs and other health boards to determine whether modifying BreEZe to include capability that would allow it to promptly notify BRN when another health board receives a complaint or takes disciplinary action against a licensed nurse is cost effective. If it is, add this functionality to BreEZe.

The BRN currently shares information with other healing arts boards pursuant to Government Code section 6254.5(e). However, the BRN has initiated contact with other health care boards to establish formal MOUs and will follow-up with Executive Officers/Directors at the scheduled Executive Officers/Directors meeting in January, 2017. The goal is to have MOUs with other health care boards in place by June 2017. The BRN has also initiated contact with other health and human services state agencies; follow-up/meetings will be conducted on January 18, 2017 with California Department of Public Health and Department of Corrections and Rehabilitation. The goal for completion for these two agencies is June 2017. Contact will be made with other agencies including, but not limited to, Department of Social Services and Community Care Licensing, Department of Justice Bureau of Medi-Cal Fraud and Elder Abuse, and Department of Aging. As previously stated in the Sunset Report, there was a recommendation from the recent enforcement audit to create legislation that requires mandatory reporting by all agencies that oversee employment of RNs or employ RNs as well as other boards or bureaus for RNs that hold multiple licenses. This legislation would require these facilities to report violations of the Nursing Practice Act to the BRN. 10.4 Public Comment for Items Not on the Agenda No Public Comment 10.5 Adjournment at 1:10 pm

Submitted by: Accepted by:

Janette Wackerly, MBA, BSN, RN, SNEC Trande Phillips, RN, Chair, Direct Practice Member Supervising Nursing Education Consultant NP Liaison

BOARD OF REGISTERED NURSING Nursing Practice Committee

Agenda Item Summary

AGENDA ITEM: 10.1 DATE: March 8, 2017

ACTION REQUESTED: Update on Rulemaking for Article 8 Standards for Nurse Practitioners; Discussion and Possible Action to Approve Proposed Responses to the Comments Received from the 15-day Comment Period

REQUESTED BY: Trande Phillips, RN, Chair

Nursing Practice Committee BACKGROUND: The regulatory proposal amending Article 8 Nurse Practitioners §1480-1485 and to add section 1483.1 Requirements for Nurse Practitioner Education Programs in California, 1483.2 Requirements for Reporting Nurse Practitioner Education Programs, 1486 Requirements for Clinical Practice Experience for Nurse Practitioner Students Enrolled in Out of State Nurse Practitioner Education Program. There was no public testimony at the hearing on September 19th, 2016. During the comment period four organizations submitted comments. As a result of the submitted comments, the Board issued Modified Text to the proposed regulations. The Modified Text comment period was from November 21, 2016 to December 7, 2016. The Modified Text that was noticed on November 21, 2016, is attached and includes both the initial and modified language. The initial changes are designated by single underline and single strikeout and the modified language is designated by red double underline and red double strikeout. The following is the summary of the comments and proposed responses from the Modified Text comment period. UC Irvine Program in Nursing Science Section 1484. Nurse Practitioner Education

• (d)(3) Faculty: Recommend that the lead nurse practitioner faculty educator who meets the faculty qualifications should be nationally certified in the same NP concentration (population foci) he or she serves as lead faulty

• (e)(1)(D) Director: Recommend that the nurse practitioner education program direct be certified by the board as a nurse practitioner and by a national certification organization as a nurse practitioner in one or more nurse practitioner concentrations.

Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national

certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Action Coalition a HealthImpact Program There are differences between California BRN certification and national board certification that are important to articulate. BRN certification ensures that NPs graduate from a California BRN-approved program. BRN certification also grants authority to practice and title protection. Every 2 years, BRN-certified NPs are required to have 30 continuing education (CE) hours to ensure the NP is current in the knowledge and practice of nursing and nurse practitioner practice. To be certified by a nationally-recognized certification organization, NPs must complete 100 CE hours over 5 years among other requirements. The national certification requirement is 25 CE hours above the BRN requirement for the same time frame of 5 years. In addition, the CEs must be completed in the certified population focus area to ensure the NP is current in trends and changes in practice. Lastly, of the 100 CEs, 25 CEs must be dedicated to pharmacology as pharmacotherapeutics can be of great benefit but also can cause great harm. Current clinical practice or re-examination is also required for recertification. These conditions of CE and either practice or re-examination for re-certification are much more stringent than the current BRN regulations and are important for the safe practice of NPs. It is recommended that the BRN require national certification for both the Program and Specialty Directors(s) to ensure the safety of students and patients. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Nursing Students’ Association Certification by a nationally recognized organization provides a rigorous assessment of clinical knowledge and competence in practice that is critical for a leader of an NP educational program. National certification for the lead nurse practitioner and program director provides substantial credibility to the program that will be preparing future nurse practitioners. Most schools of nursing that offer nurse practitioner programs recruit leaders with national certification. California programs follow the Commission on Collegiate Nursing Education

(CCNE) and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for program review that are already integrated into the national nursing education accreditation processes. The criteria have been established by national experts in NP education and reviewed by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the document and who support the requirement for national certification. These criteria are found in the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the requirement for national certification of lead faculty and directors of programs CNSA respectfully requests that the BRN require national certification for both the NP Program and Specialty Director(s). National certification will ensure the safety of our members, the current student population, future nursing students and our patients. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. American Nurses Association of California As the rightful leader in healthcare, CA is looked up to by other states in terms of our education requirements and nursing practice standards. When education standards for CA nurse practitioner programs are discussed, the issue of national certification is usually mentioned since CA NP students are all prepared and ready to sit for said exam. The need for national certification standards, in addition to CA certification and licensing standards, is especially apparent in today’s rapidly changing healthcare environment that forces us to reassess our roles, standards and responsibilities in preparing future nurse practitioners able to keep up with the latest advances in their specific area of practice. Moreover, it is important to recognize the difference between CA BRN NP and Nat’l NP Certifications. The national NP (re)certification does NOT require only 30 continuing education (CE) hours every 2 years, but 100 continuing education (CE) hours of specified NP education (i.e. CEs in certified population focus area) every 5 years which is 25 CE hours of specified evidence-based specialty education more than the current BRN license renewal requirement. Furthermore, 25 of those 100 CE hours MUST be dedicated to pharmacology only. This is significant as CA has no such NP requirement. This stringent requirement assures that CA NP Director of NP education program is up-to-date on the latest trends in national education and practice standards in his/her area of nursing practice thus appropriately qualified and responsible for NP program curriculum that ensures the safety and integrity of the NP Director, NP program and its graduates. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national

certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Association of Nurse Anesthetists Since California’s older regulations do not reflect the higher level standards, it is essential for the BRN as registered nursing’s regulatory body to move forward and validate advanced practice at the highest possible level through evidence-based means for assurances of safety and quality to the public. CANA recommends that the BRN require national certification for NP program and specialty directors to facilitate a consistent approach in the education and development of future NP leaders in California. The lack of such a requirement in policy undermines the ability of advanced level practitioners to achieve full practice authority. At the same time, we also believe it is important to consider grandfathering in those educators who have been serving in their respective roles without benefit of national certification. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. Association of California Nurse Leaders Certification by a nationally recognized organization provides a rigorous assessment of clinical knowledge and competence in practice that is critical for a leader of an NP educational program. National certification for the lead nurse practitioner and program director provides substantial credibility to the program that will be preparing future nurse practitioners. Most schools of nursing that offer nurse practitioner programs recruit leaders with national certification. California programs follow the Commission on Collegiate Nursing Education (CCNE) and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for program review that are already integrated into the national nursing education accreditation processes. The criteria have been established by national experts in NP education and reviewed by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the document and who support the requirement for national certification. These criteria are found in the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the requirement for national certification of lead faculty and directors of programs

ACNL respectfully requests that the BRN require national certification for both the NP Program and Specialty Director(s). National certification will ensure the safety of our members, the current student population, future nursing students and our patients. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Association of Clinical Nurse Specialists As advanced practice (AP) nurses working with our NP colleagues in academia, acute care, ambulatory and community settings we value the knowledge and expertise of our BRN-certified NPs. During clinical rotations NP students are receiving the benefits of preceptors hip from nationally certified NPs (as many employers are requiring APNs to have nationally certification for privileging or obtain one within the first year of employment). The academic settings that are contributing to the preparation of future NPs should be held to the same standards; as such program and specialty directors should be nationally certified. It is important for our academic colleagues to also be up-to-date with the developments in practice as they prepare future practitioners, especially during such a dynamic health care setting. It is also essential to keep in mind those educators/program/specialty directors that are currently in the role and consider grandfathering them in. We recommend that the BRN require national certification for both the Program and Specialty Director(s). Consistency in standardization in the preparation of academic and clinical NPs is key in mentoring the future workforce of NPs. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. Diane Lithgow, PhD, FNP, RN-BC, Western University In support of updating California’s Board of Registered Nursing’s regulations to require that all Directors of NP programs in BRN approved programs be nationally certified in the area of

specialty that they are Director over. This assures that the specialty NP Director is recertified via CEU updates on an ongoing basis and therefore not putting students at risk for not knowing the minimum competencies for that specialty. This also prevents potential risk for patients down the line of the care chain. Since most insurers, Medicare and Medicaid mandate national certification of any NP for reimbursement purposes, this is a moot point and nearly all California NPs must have this for employment purposes, so the Directors of specialty programs should be held to these same standards. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Association of Colleges of Nursing Certification by a nationally recognized organization provides a rigorous assessment of clinical knowledge and competence in practice that is critical for a leader of an NP educational program. National certification for the lead nurse practitioner and program director provides substantial credibility to the program that will be preparing future nurse practitioners. Most schools of nursing that offer nurse practitioner programs recruit leaders with national certification. Our programs follow the Commission on Collegiate Nursing Education (CCNE) and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for program review that are already integrated into the national nursing education accreditation processes. The criteria have been established by national experts in NP education and reviewed by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the document and who support the requirement for national certification. These criteria are found in the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the requirement for national certification of lead faculty and directors of programs CACN urges you to consider adopting the proposed language. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board.

California Association for Nurse Practitioners CANP believes that Program and Specialty Directors should receive national certification and should be required to complete 100 continuing education (CE) hours over five years in their certified population focus area, including 25 CEs in pharmacology. Requiring Program and Specialty Directors to be nationally certified will ensure NPs receive the proper training to provide direction and leadership within their respective specialties, and protect patients by ensuring appropriate training in pharmacotherapeutics. CANP recommends that both Program and Specialty Directors be required to be nationally certified. We believe this is consistent with our mission to allow NPs to play a broader role in the healthcare system and increase access to quality care. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board. California Nurse-Midwives Association The California Nurse‐Midwives Association (CNMA) believes that regulations related to NPs help raise the quality and standards for all APRNs. This includes the quality and standards that are set by requiring national certification; national certification is the mark of public safety assurance that are the ultimate responsibility and authority of licensing boards. Program and Specialty Directors of BRN-approved nurse practitioner programs should be nationally certified for mean reasons. First, having national certification, assures that the Directors are keeping up with the trends in practice and pharmacology. Second, national certification for Specialty Directors ensures that an appropriately-trained NP is providing leadership within the specialty. Recommend that the BRN require national certification for both the Program and Specialty Director(s). This will ensure the safety of students and patients. Proposed Response: Reject the comment. The nurse practitioner education program director and the lead nurse practitioner faculty educator instructor do not need to be certified by a national certification organization because the Board is not requiring applicants for nurse practitioner certification to successfully complete a program of study that has been approved or endorsed by any national certification organization. Furthermore, neither of these positions would require intimate or specialized knowledge of the certification process promulgated by any national certification organization since the Board is not relying exclusively upon an applicant possessing national certification as one of the requirements for certification by the Board.

NEXT STEPS: Place on Board agenda. FISCAL IMPACT, IF ANY: None PERSON(S) TO CONTACT: Janette Wackerly, MBA, BSN, RN

Supervising Nursing Education Consultant Janette.Wackerly@dca.ca.gov (916) 574-7686

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BOARD OF REGISTERED NURSING

MODIFIED TEXT

Proposed amendments are shown by single underline for new text and single strikeout for deleted text.

Modified text to the originally proposed language are shown by red double underline for new text

and by red double strikeout for deleted text. 1480. Definitions. (a) “Nurse practitioner” means an advanced practice registered nurse who meets board education

and certification requirements and possesses additional advanced practice educational preparation and skills in physical diagnosis, psycho-social assessment, and management of health-illness needs in primary health care, and/or acute care. who has been prepared in a program conforms to board standards as specified in Section 1484.

(b) “Primary health care” is that which occurs when a consumer makes contact with a health care provider who assumes responsibility and accountability for the continuity of health care regardless of the presence or absence of disease. “Primary care” means comprehensive and continuous care provided to patients, families, and the community. Primary care focuses on basic preventative care, health promotion, disease prevention, health maintenance, patient education and the diagnoses and treatment of acute and chronic illnesses in a variety of practice settings.

(c) “Clinically competent” means that one the individual possesses and exercises the degree of learning, skill, care and experience ordinarily possessed and exercised by a member of the appropriate discipline in clinical practice certified nurse practitioner providing healthcare in the same nurse practitioner category.

(d) “Holding oneself out” means to use the title of nurse-practitioner. “Acute care” means restorative care provided by the nurse practitioner to patients with rapidly changing, unstable, chronic, complex acute and critical conditions in a variety of clinical practice settings.

(e) “Category” means the population focused area of practice in which the certified nurse practitioner provides patient care.

(f) “Advanced health assessment” means the knowledge of advanced processes of collecting and interpreting information regarding a patient’s health care status. Advanced health assessment provides the basis for differential diagnoses and treatment plans.

(g) “Advanced pathophysiology” means the advanced knowledge and management of physiological disruptions that accompany a wide range of alterations in health.

(h) “Advanced pharmacology” means the integration of the advanced knowledge of pharmacology, pharmacokinetics, and pharmacodynamics content across the lifespan and prepares the certified nurse practitioner to initiate appropriate pharmacotherapeutics safely and effectively in the management of acute and chronic health conditions.

(i) “Nurse practitioner curriculum” means a curriculum that consists of the graduate core; advanced practice registered nursing core, and nurse practitioner role and population-focused courses.

(j) “Graduate core” means the foundational curriculum content deemed essential for all students pursuing a graduate degree in nursing.

(k) “Advanced practice registered nursing core” means the essential broad-based curriculum required for all nurse practitioner students in the areas of advanced health assessment, advanced pathophysiology, and advanced pharmacology.

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(l) “California based nurse practitioner education program” means a board approved academic program, physically located in California that offers a graduate degree or graduate level certificate to qualified students and is accredited by a nursing organization recognized by the United States Department of Education or the Council of Higher Education Accreditation.

(m) “Clinical practice experience” means supervised direct patient care in the clinical setting that provides for the acquisition and application of advanced practice nursing knowledge, skills, and competencies.

(n) “Direct supervision of students” means a clinical preceptor or a faculty member is physically present at the practice site. The clinical preceptor or faculty member retains the responsibility for patient care while overseeing the student.

(o) “Lead nurse practitioner educator faculty” means the nurse practitioner faculty member of the nurse practitioner education program who has administrative responsibility for developing and implementing the curriculum in the nurse practitioner category.

(p) “Major curriculum change” means a substantive change in a nurse practitioner education program curriculum, structure, content, method of delivery, or clinical hours.

(q) “National Certification” means the certified nurse practitioner has passed an examination provided by a national certification organization accredited by the National Commission for Certifying Agencies or the American Board of Nursing Specialties, as approved by the board.

(r) “Nurse practitioner education program director” means the individual responsible for administration, implementation, and evaluation of the nurse practitioner education program and the achievement of the program outcomes in collaboration with program faculty.

(s) “Non-California based nurse practitioner education programs” means an academic program accredited by a nursing organization recognized by the Unites States Department of Education or the Council of Higher Education Accreditation that offers a graduate degree or graduate level certificate to qualified students and does not have a physical location in California.

Authority cited: Sections 2715, 2725(c), 2725.5, 2835.5, 2836, 2836.1, Business and Professions Code. References: Section 2725.5, 2834, 2835.5, and 2836.1, Business and Professions Code. 1481. Categories of Nurse Practitioners. A registered nurse who has met the requirements of Section 1482 for holding out as a nurse practitioner, may be known as a nurse practitioner and may place the letters “R.N., N.P.” after his/her name alone or in combination with other letters or words identifying categories of specialization, including but not limited to the following: adult nurse practitioner, pediatric nurse practitioner, obstetrical-gynecological nurse practitioner, and family nurse practitioner. (a) Categories of nurse practitioners shall include, but are not limited to the following:

(1) Family/individual across the lifespan; (2) Adult-gerontology, primary care or acute care; (3) Neonatal; (4) Pediatrics, primary care or acute care; (5) Women’s health/gender-related; (6) Psychiatric-Mental Health across the lifespan.

(b) A registered nurse who has been certified by the board as a nurse practitioner may use the title, “advanced practice registered nurse” and/or “certified nurse practitioner” and may place the letters APRN-CNP after his or her name or in combination with other letters or words that identify the category.

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Authority cited: Sections 2715, 2835.5, 2836, Business and Professions Code. Reference: Sections 2834, and 2835.5, 2836, 2836.1, and 2837, Business and Professions Code. 1482. Requirements for Holding Out As a Certification as a Nurse Practitioner. The requirements for holding oneself out as a nurse practitioner are: (a) To obtain certification as a Nurse Practitioner, an applicant must hold a valid and active license as a registered nurse in California and possess a master’s degree in nursing, a master’s degree in a clinical field related to nursing, or a graduate degree in nursing and one of the following: (a) active licensure as a registered nurse in California; and (b) one of the following: (1) Successful completion of a nurse practitioner education program approved by the Board; of study which conforms to board standards; or (2) National Ccertification as a nurse practitioner by a national or state organization whose standards are equivalent to those set forth in Section 1484; or in one or more categories from a national certification organization accredited by the National Commission on Certifying Agencies or the American Board of Nursing Specialties, as approved by the Board. (3) (b) A nurse who has not completed an academically affiliated nurse practitioner education program of study which meets board standards as specified in Section 1484, or shall be able to provide: evidence of having completed equivalent education and supervised clinical practice, as set forth in this article. (A) Documentation of remediation of areas of deficiency in course content and/or clinical experience, and (B) Verification by a nurse practitioner and by a physician who meet the requirements for faculty members specified in Section 1484(c), of clinical competence in the delivery of primary health care. (c) Graduates who have completed a nurse practitioner education program in a foreign country shall meet the requirements as set forth in this article. The applicant shall submit the required credential evaluation through a board-approved evaluation service evidencing education equivalent to a master’s or doctoral degree in Nursing. Note: Authority cited: Section 2715, Business and Professions Code. Reference: Sections 2835, and 2836, Business and Professions Code. 1483. Evaluation of Credentials. (a) An application for evaluation of a registered nurse's qualifications to hold out to be certified as a nurse practitioner shall be filed with the board by submitting forms Application Requirements for Nurse Practitioner (NP) Certification (rev 5/2014) and Nurse Practitioner Furnishing Number Application (rev 10/2012), hereby incorporated by reference, which on a form prescribed by the board and shall be accompanied by the fee prescribed in Section 1417 and such evidence, statements or documents as therein required by the board. to conform with Sections 1482 and 1484. c (b) A Nurse Practitioner application shall include submission of the following information:

(1) Name of the graduate nurse practitioner education program or post-graduate nurse education practitioner program.

(2) Official sealed transcript with the date of graduation or post-graduate program completion, nurse practitioner category, credential conferred, and the specific courses taken to provide sufficient evidence the applicant has completed the required course work including the required number of supervised direct patient care clinical practice hours.

c

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(c) A graduate from a board-approved nurse practitioner education program shall be considered a graduate of a nationally accredited program if the program held national nursing accreditation at the time the graduate completed the program. The program graduate is eligible to apply for nurse practitioner certification with the board regardless of the program’s national nursing accreditation status at the time of submission of the application to the Board. c (d) The board shall notify the applicant in writing that the application is complete and accepted for filing or that the application is deficient and what specific information is required within 30 days from the receipt of an application. A decision on the evaluation of credentials shall be reached within 60 days from the filing of a completed application. The median, minimum, and maximum times for processing an application, from the receipt of the initial application to the final decision, shall be 42 days, 14 days, and one year, respectively, taking into account Section 1410.4(e) which provides for abandonment of incomplete applications after one year. Note: Authority cited: Sections 2715, and 2718, Business and Professions Code. Reference: Sections 2815, and 2835.5, Business and Professions Code. 1483.1 Requirements for Nurse Practitioner Education Programs in California. (a) The nurse practitioner education program shall:

(1) Provide evidence to the board that the nurse practitioner program is in an accredited academic institution located in California.

(2) Be an academic program approved by the board and accredited by a nursing organization recognized by the United States Department of Education or the Council of Higher Education Accreditation that offers a graduate degree or graduate level certificate to qualified students.

(3) Provide the board with evidence of ongoing continuing nurse practitioner education program accreditation within 30 days of the program receiving this information from the national nursing accreditation body.

(4) Notify the board of changes in the program’s institutional and national nursing accreditation status within 30 days.

(b) The board may grant the nurse practitioner education program initial and continuing approval when the board receives the required accreditation evidence from the program. (c) The board may change the approval status for a board-approved nurse practitioner education program at any time, if the board determines the program has not provided necessary compliance evidence to meet board regulations notwithstanding institutional and national nursing accreditation status and review schedules. Authority cited: Section 2715, Business and Professions Code. Reference: Sections 2785, 2786, 2786.5, 2786.6, 2788, 2798, 2815, and 2835.5, Business and Professions Code. 1483.2 Requirements for Reporting Nurse Practitioner Education Program Changes. (a) A board-approved nurse practitioner education program shall notify the board within thirty (30) days of any of the following changes:

(1) A change of legal name or mailing address prior to making such changes. The program shall file its legal name and current mailing address with the board at its principal office and the notice shall provide both the old and the new name and address as applicable.

(2) A fiscal condition that adversely affects students enrolled in the nursing program. (3) Substantive changes in the organizational structure affecting the nursing program.

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(b) An approved nursing program shall not make a substantive change without prior board notification. Substantive changes include, but are not limited to the following:

(1) Change in location; (2) Change in ownership; (3) Addition of a new campus or location; (4) Major curriculum change.

Authority cited: Section 2715, Business and Professions Code. Reference: Sections 2785, 2786, 2786.5, 2786.6, 2788, 2798, 2815, and 2835.5, Business and Professions Code. 1484. Standards of Nurse Practitioner Education. c (a) The program of study preparing a nurse practitioner shall meet the following criteria: be approved by the board and be consistent with the nurse practitioner curriculum core competencies as specified by the National Organization of Nurse Practitioner Faculties. (a) (b) Purpose, Philosophy and Objectives (1) have as its primary purpose the preparation of registered nurses who can provide primary health care; The purpose of the nurse practitioner education program shall be to prepare a graduate nurse practitioner to provide competent primary care and/or acute care services in one or more of the categories. (2) have a clearly defined philosophy available in written form; Written program materials shall reflect the mission, philosophy, purposes, and outcomes of the program and be available to students. (3) have objectives which reflect the philosophy, stated in behavioral terms, describing the theoretical knowledge and clinical competencies of the graduate. Learning outcomes for the nurse practitioner education program shall be measurable and reflect assessment and evaluation of the theoretical knowledge and clinical competencies required of the graduate. (b) (c) Administration and organization of the nurse practitioner education program shall: (1) Be conducted in conjunction with one of the following: (A) (1) An institution of higher education that offers a baccalaureate or higher degree in nursing, medicine, or public health. Be taught in a college or university accredited by a nursing organization that is recognized by the United States Department of Education or the Council of Higher Education Accreditation that offers a graduate degree to qualified students. (B) (2) A general acute care hospital licensed pursuant to Chapter 2 (Section 1250) of Division 2 of the Health and Safety Code, which has an organized outpatient department. Prepare graduates for national certification as a certified nurse practitioner in one or more nurse practitioner category by the National Commission on Certifying Agencies or the American Board of Nursing Specialties. (2) (3) Have admission requirements and policies for withdrawal, dismissal and readmission that are clearly stated and available to the student in written form. (3) (4) Have written policies for clearly Iinforming applicants of the academic accreditation and board approval status of the program. (4) (5) Provide the graduate with official evidence indicating that he/she has demonstrated clinical competence in delivering primary health care and has achieved all other objectives of the program. Document the nurse practitioner role and the category of educational preparation on the program’s official transcript. (5) (6) Maintain systematic, retrievable records of the program including philosophy, objectives, administration, faculty, curriculum, students and graduates. In case of program discontinuance, the board shall be notified of the method provided for record retrieval. Maintain a method for retrieval of records in the event of program closure.

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(6) (7) Provide for program evaluation by faculty and students during and following the program and make results available for public review. Have and implement a written total program evaluation plan. (8) Have sufficient resources to achieve the program outcomes. (c) (d) Faculty. There shall be an adequate number of qualified faculty to develop and implement the program and to achieve the stated objectives. (1) There shall be an adequate number of qualified faculty to develop and implement the program and to achieve the stated outcomes. (1) (2) Each faculty person member shall demonstrate current competence in the area in which he/ or she teaches. (3) There shall be a lead nurse practitioner faculty educator who meets the faculty qualifications and is nationally certified in the same category track he or she serves as the lead faculty. (4) Faculty who teach in the nurse practitioner education program shall be educationally qualified and clinically competent in the same category as the theory and clinical areas taught. Faculty shall meet the following requirements:

(A) Hold an active, valid California registered nurse license; (B) Have a Master’s degree or higher degree in nursing; (C) Have at least two years of clinical experience as a nurse practitioner, certified nurse midwife, clinical nurse specialist, or certified registered nurse anesthetist within the last five (5) years of practice and consistent with the teaching responsibilities.

(5) Faculty teaching in clinical courses shall be current in clinical practice. (6) Each faculty member shall assume responsibility and accountability for instruction, planning, and implementation of the curriculum, and evaluation of students and the program. (7) Interdisciplinary faculty who teach non-clinical nurse practitioner nursing courses, such as but not limited to, pharmacology, pathophysiology, and physical assessment, shall have a valid and active California license issued by the appropriate licensing agency and an advanced graduate degree in the appropriate content areas. (e) Director. (1) The nurse practitioner education program director shall be responsible and accountable for the nurse practitioner education program within an accredited academic institution including the areas of education program, curriculum design, and resource acquisition, and shall meet the following requirements: (2) The director or co-director of the program shall:

(A) be a Hold an active, valid California registered nurse license; (B) Have hold a Master's or a higher degree in nursing or a related health field from an accredited

college or university; (C) Hhave had one academic year of experience, within the last five (5) years, as an

instructor in a school of professional nursing, or in a program preparing nurse practitioners.

(D) Be certified by the board as a nurse practitioner and by a national certification organization as a nurse practitioner in one or more nurse practitioner categories. (2) The director, if he or she meets the requirements for the certified nurse practitioner role, may fulfill the lead nurse practitioner faculty educator role and responsibilities. (f) Clinical Preceptors. (1) A clinical preceptor in the nurse practitioner education program shall: (3) Faculty in the theoretical portion of the program must include instructors who hold a Master's or higher degree in the area in which he or she teaches.

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(4) (A) A clinical instructor shall Hhold an active licensure valid, California license to practice his/ or her respective profession and demonstrate current clinical competence. (5) (B) A clinical instructor shall Pparticipate in teaching, supervising, and evaluating students, and shall be appropriately matched competent with in the content and skills being taught to the students. (2) A clinical preceptor is a health care provider qualified by education, licensure and clinical competence in a nurse practitioner category and who provides direct supervision of the clinical practice experiences for a nurse practitioner student. (3) Clinical preceptor functions and responsibilities shall be clearly documented in a written agreement between the agency, the preceptor, and the nurse practitioner education program including the clinical preceptor’s role to teach, supervise and evaluate students in the nurse practitioner education program. (4) A clinical preceptor is oriented to program and curriculum requirements, including responsibilities related to student supervision and evaluation; (5) A clinical preceptor shall be evaluated by the program faculty at least every two (2) years. (d) (g) Curriculum Students shall hold an active, valid California registered nurse license to participate in nurse practitioner education program clinical experiences. (h) Nurse Practitioner Education Program Curriculum. The nurse practitioner education program curriculum shall include all theoretical and clinical instruction that meet the standards set forth in this section and be consistent with national standards for graduate and nurse practitioner education, including nationally recognized core role and category competencies and be approved by the board. (1) The program shall include all theoretical and clinical instruction necessary to enable the graduate to provide primary health care for persons for whom he/she will provide care. (2) The program shall provide evaluation evaluate of previous education and/ or experience in primary health care for the purpose of granting credit for meeting program requirements. (3) (2) Training for practice in an area of specialization shall be broad enough, not only to detect and control presenting symptoms, but to minimize the potential for disease progression. The curriculum shall provide broad educational preparation and include a graduate core, advance practice registered nurse core, the nurse practitioner core role competencies, and the competencies specific to the category. (4) (3) Curriculum, course content, and plans for clinical experience shall be developed through collaboration of the total faculty. The program shall prepare the graduate to be eligible to sit for a specific national nurse practitioner category certification examination consistent with educational preparation. (5) (4) Curriculum, course content, methods of instruction and clinical experience shall be consistent with the philosophy and objectives of the program. The curriculum plan shall have appropriate course sequencing and progression, which includes, but is not limited to the following:

(A) The advance practice registered nursing graduate core courses in advanced health assessment, advanced pharmacology, and advanced pathophysiology shall be completed prior to or concurrent with commencing clinical course work. (B) Instruction and skills practice for diagnostic and treatment procedures shall occur prior to application in the clinical setting. (C) Concurrent theory and clinical practice courses in the category shall emphasize the management of health-illness needs in primary and/or acute care. (D) The supervised direct patient care precepted clinical experiences shall be under the supervision of the certified nurse practitioner and or physician.

(6) (5) Outlines and descriptions of all learning experiences shall be available, in writing, prior to enrollment of students in the program. The program shall meet the minimum of 500 clinical hours of

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supervised direct patient care experiences as specified in current nurse practitioner national education standards. Additional clinical hours required for preparation in more than one category shall be identified and documented in the curriculum plan for each category. (6) The nurse practitioner education curriculum shall include content related to California Nursing Practice Act, Business & Professions Code, Division 2, Chapter 6, Article 8, Nurse Practitioners and California Code of Regulations Title 16, Division 14, Article 7 Standardized Procedure Guidelines and Article 8 Standards for Nurse Practitioners, including, but not limited to: (A) Section 2835.7 of Business & Professions Code Authorized standardized procedures; (B) Section 2836.1 of Business & Professions Code Furnishing or ordering of drugs or devices by nurse practitioners, and other appropriate codes, Pharmacy, Welfare and Institution. (7) The program may be full-time or part-time, and shall be comprised of not less than thirty (30) semester units, (forty-five (45) quarter units), and shall be consistent with national standards for graduate and nurse practitioner education, which shall that include theory and supervised clinical practice. (8) The course of instruction shall be calculated according to the following formula: The course of instruction program units and contact hours shall be calculated using the following formulas: (A) One (1) hour of instruction in theory each week throughout a semester or quarter equals one (1) unit. One (1) hour of instruction in theory each week throughout a semester or quarter equals one (1) unit. (B) Three (3) hours of clinical practice each week throughout a semester or quarter equals one (1) unit. Three (3) hours of clinical practice each week throughout a semester or quarter equals one (1) unit. Academic year means two semesters, where each semester is 15-18 weeks; or three quarters, where each quarter is 10-12 weeks. (C) One (1) semester equals 16-18 weeks and one (1) quarter equals 10-12 weeks. (9) Supervised clinical practice shall consist of two phases: at least 12 semester units or 18 quarter units.

(A) Concurrent with theory, there shall be provided for the student, demonstration of and supervised practice of correlated skills in the clinical setting with patients. (B) Following acquisition of basic theoretical knowledge prescribed by the curriculum the student shall receive supervised experience and instruction in an appropriate clinical setting. (C) At least 12 semester units or 18 quarter units of the program shall be in clinical practice.

(10) The duration of clinical experience and the setting shall be such that the student will receive intensive experience in performing the diagnostic and treatment procedures essential to the practice for which the student is being prepared shall be sufficient for the student to demonstrate clinical competencies in the nurse practitioner category. (11) The nurse practitioner education program shall have the responsibility arrange for arranging for clinical instruction and supervision for of the student. (12) The curriculum shall include, but is not limited to: (A) Normal growth and development (B) Pathophysiology (C) Interviewing and communication skills (D) Eliciting, recording and maintaining a developmental health history (E) Comprehensive physical examination (F) Psycho-social assessment (G) Interpretation of laboratory findings (H) Evaluation of assessment date to define health and developmental problems (I) Pharmacology (J) Nutrition

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(K) Disease management (L) Principles of health maintenance (M) Assessment of community resources (N) Initiating and providing emergency treatments (O) Nurse practitioner role development (P) Legal implications of advanced practice (Q) Health care delivery systems (13) The course of instruction of a program conducted in a non-academic setting shall be equivalent to that conducted in an academic setting. Authority cited: Sections 2715, 2835.5, 2835.7, 2836, 2836.1, Business and Professions Code. Reference: Sections 2835, 2835.5, 2835.7, 2836, 2836.1, 2836.2, 2836.3, 2837, Business and Professions Code. 1486. Requirements for Clinical Practice Experience for Nurse Practitioner Students Enrolled in Out-of-State Nurse Practitioner Education Programs. (a) The out-of-state Nurse Practitioner education program requesting clinical placements for students

in clinical practice settings in California shall: (1) Obtain prior board approval; (2) Ensure students have successfully completed prerequisite courses and are enrolled in the

nurse practitioner education program; (3) Secure clinical preceptors who meet board requirements; (4) Ensure the clinical preceptorship experiences in the program meet all board requirements and

national education standards and competencies for the nurse practitioner role and population; (5) A clinical preceptor in the nurse practitioner education program shall: (a) Hold a valid and active California license to practice his or her respective profession and

demonstrate current clinical competence. (b) Participate in teaching, supervising, and evaluating students, and shall be competent in the

content and skills being taught to the students. (c) Be a health care provider qualified by education, licensure and clinical competence in the

assigned nurse practitioner category to provide direct supervision of the clinical practice experiences for a nurse practitioner student.

(d) Be oriented to program and curriculum requirements, including responsibilities related to student supervision and evaluation;

(e) Be evaluated by the program faculty at least every two (2) years. Clinical preceptor functions and responsibilities shall be clearly documented in a written agreement between the agency, the preceptor, and the nurse practitioner education program including the clinical preceptor’s role to teach, supervise and evaluate students in the nurse practitioner education program.

(b) Students shall hold an active, valid California registered nurse license to participate in nurse practitioner education program clinical experiences.

(c) The nurse practitioner education program shall demonstrate evidence that the curriculum includes content related to legal aspects of California certified nurse practitioner laws and regulations.

(1) The curriculum shall include content related to California Nursing Practice Act, Business & Professions Code, Division 2, Chapter 6, Article 8, Nurse Practitioners and California Code of Regulations Title 16, Division 14, Article 7 Standardized Procedure Guidelines and Article 8 Standards for Nurse Practitioners, including, but not limited to:

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(A) Section 2835.7 of Business & Professions Code Authorized standardized procedures; (B) Section 2836.1 of Business & Professions Code Furnishing or ordering of drugs or devices by nurse practitioners, and other appropriate codes, Pharmacy, Welfare and Institution.

(d) The nurse practitioner education program shall notify the board of pertinent changes within 30 days.

(e) The board may withdraw authorization for program clinical placements in California, at any time. Authority cited: Section 2715, Business and Professions Code. Reference: Sections 2729, 2835, 2835.5, and 2836, Business and Professions Code.

UNIVERSITY OF CALIFORNIA, IRVINE BERKELEY • DAVIS • IRVINE • LOS ANGELES • MERCED • RIVERSIDE • SAN DIEGO • SAN FRANCISCO SANTA BARBARA • SANTA CRUZ

Office of the Director Program in Nursing Science 252D Berk Hall

Irvine, CA 92697-3959 PHONE: 949-824-9057 FAX: 949-824-0470 December 5, 2016 Ronnie Whitaker, Regulations Coordinator Board of Registered Nursing 1747 N. Market Blvd., Suite 150 Sacramento, CA 95834 Ronnie.whitaker@dca.ca.gov Re: Proposed Modifications: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification Dear Members of the Board of Registered Nursing,

The University of California, Irvine Program in Nursing Science applauds the Board of Registered Nursing for revising and updating Title 16 regulations pertaining to Nurse Practitioners. Our program has been educating primary care nurse practitioners for twenty-one years and our faculty has been actively engaged in national nurse practitioner curricular leadership since that time.

Pertaining to the new proposed modifications provided to the public effective November 22,

2016, we respectfully make the following recommendations to ensure safety and integrity of NP graduates: 1484. Nurse Practitioner Education.

• (d) (3) Faculty: We strongly recommend that the lead nurse practitioner faculty educator who meets the faculty qualifications should be nationally certified in the same NP concentration (population foci) he or she serves as lead faculty.

o Rationale: This requirement, as recommended by expert, nationally-recognized nurse practitioner educator leaders, is necessary to ensure that appropriately-trained NPs are providing curricular leadership within the NP concentration.

• (e) (1) (D) Director: We strongly recommend the nurse practitioner education program director be certified by the board as a nurse practitioner and by a national certification organization as a nurse practitioner in one or more nurse practitioner concentrations.

o Rationale: This requirement, as recommended by expert, nationally-recognized nurse practitioner educator leaders, is necessary to ensure the Directors are current in state and national trends in practice and pharmacology.

We understand that the National Organization of Nurse Practitioner Faculties, the national leader in nurse practitioner curricular development and educational leadership, has provided similar recommendation to this Board. This criterion has been endorsed by the Commission on Collegiate Nursing Education as well as the National League for Nursing and has been integrated into the nursing education accreditation process. The Program in Nursing Science at the University of California, Irvine fully supports the language and intent to require lead faculty and program directors to be certified by a national organization. We most strongly advocate that national certification is an important requirement for creating and maintaining a strong NP educational program. Respectfully submitted,

Alison Holman, Ph.D., RN, FNP Interim Director, UC Irvine Program in Nursing Science

November 22, 2016

Ronnie Whitaker 1747 N. Market Blvd., Suite 150 Sacramento, CA 95834 Ronnie.whitaker@dca.ca.gov Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification Dear Members of the Board of Registered Nursing, We would like to personally thank the Board of Registered Nursing for revising and updating Title 16 regulations pertaining to nurse practitioners (NPs). This is an important step forward to ensuring that California regulations stay abreast of current needs in an ever-changing healthcare environment. As BRN-certified NPs, we value our certification as it is the mark of public safety assurance that are the ultimate responsibility and authority of licensing boards. There are differences between California BRN certification and national board certification that are important to articulate. BRN certification ensures that NPs graduate from a California BRN-approved program. BRN certification also grants authority to practice and title protection. Every 2 years, BRN-certified NPs are required to have 30 continuing education (CE) hours to ensure the NP is current in the knowledge and practice of nursing and nurse practitioner practice. To be certified by a nationally-recognized certification organization, NPs must complete 100 CE hours over 5 years among other requirements. The national certification requirement is 25 CE hours above the BRN requirement for the same time frame of 5 years. In addition, the CEs must be completed in the certified population focus area to ensure the NP is current in trends and changes in practice. Lastly, of the 100 CEs, 25 CEs must be dedicated to pharmacology as pharmacotherapeutics can be of great benefit but also can cause great harm. Current clinical practice or re-examination is also required for recertification. These conditions of CE and either practice or re-examination for re-certification are much more stringent than the current BRN regulations and are important for the safe practice of NPs. Program and Specialty Directors should be nationally certified for many reasons. First, having national certification, as mentioned above, assures that the Directors are keeping up with trends in practice and pharmacology. Second, national certification for Specialty Directors ensures that an appropriately- trained NP is providing curricular leadership within the specialty. The proposed regulations are drafted to ensure the safety and integrity of the NP and of graduates. The following provides an example to highlight the importance of the concept of national certification:

Dr. Chan is educated, trained, and nationally certified as an Acute Care Nurse Practitioner (ACNP). While he is qualified to take care of critically ill patients in the Adult/Gerontology populations, it would be unsafe for him to direct a Neonatal Nurse Practitioner (NNP) program. Without the requirement of a being nationally certified as the Specialty Director in the population focus of the NNP program, Dr. Chan could, without violation of regulation or statute, be allowed to serve as the Specialty Director of the NNP program and therefore put students at

risk for not knowing the minimum competencies for NNP practice. This could eventually place patients at risk for adverse outcome.

On behalf of the California Action Coalition representing both professional nurse practitioners and nurse practitioner faculty with expertise in nationally-developed NP competencies, we strongly recommend that the BRN require national certification for both the Program and Specialty Director(s). This will ensure the safety of students and patients. Please feel free to contact us if you have any questions. Sincerely, Garrett Chan, PhD, NP, CNS, ACNP-C, CNS-BC Susanne Phillips, DNP, NP, FNP-BC gchan_rn@me.org sjphilli@uci.edu Co-Leads, Recommendation #1 Work Group California Action Coalition

Mary Dickow, MPA | Statewide Director | 415 307 9476 | marydickow@me.com | CAactioncoalition.org

December 5, 2016 Ronnie Whitaker Regulations Coordinator Board of Registered Nursing 1747 N. Market Blvd, Ste. 150 Sacramento, CA 95834 Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification Dear Members of the Board of Registered Nursing, The California Nursing Students’ Association (CNSA) supports the language in the proposed regulations that would require all California Board-approved nurse practitioner education programs to have a lead nurse practitioner faculty educator (subsection (d)(3)), and a nurse practitioner education program director (subsection (e)), who are certified by a national certification organization. Certification by a nationally recognized organization provides a rigorous assessment of clinical knowledge and competence in practice that is critical for a leader of an NP educational program. National certification for the lead nurse practitioner and program director provides substantial credibility to the program that will be preparing future nurse practitioners. Most schools of nursing that offer nurse practitioner programs recruit leaders with national certification. California programs follow the Commission on Collegiate Nursing Education (CCNE) and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for program review that are already integrated into the national nursing education accreditation processes. The criteria have been established by national experts in NP education and reviewed by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the document and who support the requirement for national certification. These criteria are found in the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the requirement for national certification of lead faculty and directors of programs CNSA respectfully requests that the BRN require national certification for both the NP Program and Specialty Director(s). National certification will ensure the safety of our members, the current student population, future nursing students and our patients. If we can be of additional assistance, please contact me at 916-779-6949. Sincerely,

Patricia McFarland, MS, RN, FAAN CEO California Nursing Students’ Association

Ronnie Whitaker 1747 N. Market Blvd. Suite 150 Sacramento, CA 95834 Dec 6th, 2016 RE: Nurse Practitioners - Action to Amend Title 16 of the California Code of Regulations To the Members of the Board of Registered Nursing, ANA\C is a bi-partisan professional organization representing the interests of nearly 400,000 licensed registered nurses in California. Our mission is to advance the quality of health care and ethical practice of nursing in contemporary society through legislation, regulations and policy advocacy. ANA\C has been extensively involved in legislative and regulatory efforts, supporting many bills and updating regulations that are assisting in making California a place of nursing excellence. ANA\C appreciates the Board of Registered Nursing in taking the time and effort to revise and update Title 16 regulations pertaining to the language and requisites for Nurse Practitioners (NPs). As the rightful leader in healthcare, CA is looked up to by other states in terms of our education requirements and nursing practice standards. When education standards for CA nurse practitioner programs are discussed, the issue of national certification is usually mentioned since CA NP students are all prepared and ready to sit for said exam. The need for national certification standards, in addition to CA certification and licensing standards, is especially apparent in today’s rapidly changing healthcare environment that forces us to reassess our roles, standards and responsibilities in preparing future nurse practitioners able to keep up with the latest advances in their specific area of practice. As healthcare professionals, it is our duty to stay educated at the top of our profession and/or specialty by assuring NPs are certified at the highest level of national competency, to deliver the highest standards of care to our patients and clients, and to protect the public from those unable or unqualified to do so. Moreover, it is important to recognize the difference between CA BRN NP and Nat’l NP Certifications. The national NP (re)certification does NOT require only 30 continuing education (CE) hours every 2 years, but 100 continuing education (CE) hours of specified NP education (i.e. CEs in certified population focus area) every 5 years which is 25 CE hours of specified evidence-based specialty education more than the current BRN license renewal requirement. Furthermore, 25 of those 100 CE hours MUST be dedicated to pharmacology only. This is significant as CA has no such NP requirement. This stringent requirement assures that CA NP Director of NP education program is up-to-date on the latest trends in national education and practice standards in his/her area of nursing practice thus appropriately qualified and responsible for NP program curriculum that ensures the safety and integrity of the NP Director, NP program and its graduates.

1121 L Street, Suite 406 Sacramento, CA 95814 O: (916) 346-4590 E: anac@anacalifornia.org

As a professional nursing association, whose members are RNs, APRNs, NPs and nursing faculty alike, we appreciate BRN’s ongoing effort in updating nurse practitioner standards and regulation that are aligned with today’s changing practice environment. We are aware of the amount of work and dedication it takes to update a regulatory section and we would like to express our thanks and gratitude to the Board Members and acknowledge the tireless work of BRN staff.

Please, do not hesitate to contact us on this matter.

We remain your trusted partner.

Thank you, Marketa Houskova ___________________________________________ Marketa Houskova, RN, MAIA, BA Interim State Director Government Affairs Director | Senior Policy Analyst American Nurses Association\ California marketa@anacalifornia.org

1121 L Street, Suite 406 Sacramento, CA 95814 O: (916) 346-4590 E: anac@anacalifornia.org

CANA ♦ PO Box 1412 ♦ Sonoma, CA 95476 ♦ TEL 707-480-0096 ♦ FAX 707-581-1706

President

Maricel Reighard, DNAP, CRNA

President-Elect

Elizabeth Bamgbose, PhD, CRNA

Treasurer

Dawn Clark, DNP, CRNA

Secretary

Debra Malina, DNSc, MBA, CRNA

Three Year Director

Gayle Ulshafer, MSN, CRNA

Trustees

Nathan Adams, MSNA, CRNA

Terence Burrows, DNAP, CRNA

Nilu Patel, DNAP, CRNA,

Richard Paulsen, MSN, CRNA

Student Representatives

Alison Goltermann, SRNA – USC

Andy Chang, SRNA – SMU

Johnny Garza, SRNA – LLU

Ellison Concepcion, SRNA – CSUF

Kristina Hintzsche, SRNA – NU

Association Manager

Mary Davis, BS

Mission Statement

CANA - the leader in advancing

patient safety, fostering access to

the highest quality anesthesia care,

and supporting the profession of

nurse anesthesia in California.

CRNAs: The solution for a healthier California

November 22, 2016

Mr. Ronnie Whitaker

1747 North Market Blvd, Suite 150

Sacramento, CA 95834

Ronnie.Whitaker@dca.ca.gov

Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National

Certification

Dear Members of the Board of Registered Nursing,

On behalf of the California Association of Nurse Anesthetists (CANA), we would like to

thank the Board of Registered Nursing (BRN) for updating Title 16 regulations pertaining to

nurse practitioners (NPs). We strongly urge the BRN to continue this work to ensure the

safety of the public by aligning California regulations to meet current standards of excellence.

The development of the 1980s version of California NP regulations was based on educational

preparation during a time when few national educational and credentialing standards existed.

The identification of nationally-vetted core and population-focused competencies for NP

entry into practice upon graduation evolved significantly between 2000 and 2011. Since

California’s older regulations do not reflect the higher level standards, it is essential for the

BRN as registered nursing’s regulatory body to move forward and validate advanced practice

at the highest possible level through evidence-based means for assurances of safety and

quality to the public.

As a professional association representing APRNs, CANA strongly recommends that the

BRN require national certification for NP program and specialty directors to facilitate a

consistent approach in the education and development of future NP leaders in California. The

lack of such a requirement in policy undermines the ability of advanced level practitioners to

achieve full practice authority. At the same time, we also believe it is important to consider

grandfathering in those educators who have been serving in their respective roles without

benefit of national certification. Of note, all CRNAs must pass the national certifying

examination in order to be eligible to use the title “certified registered nurse anesthetist,”

inclusive of CRNA program directors and educators.

Thank you for your time and attention to this matter. If I can provide additional information,

please feel free to contact me.

Sincerely,

Maricel Reighard, DNAP, CRNA

CANA President

California Association of Nurse Anesthetists, Inc.

December 5, 2016 Ronnie Whitaker Regulations Coordinator Board of Registered Nursing 1747 N. Market Blvd, Ste. 150 Sacramento, CA 95834 Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification Dear Members of the Board of Registered Nursing, The Association of California Nurse Leaders, the voice of nursing leadership, supports the language in the proposed regulations that would require all California Board-approved nurse practitioner education programs to have a lead nurse practitioner faculty educator (subsection (d)(3)), and a nurse practitioner education program director (subsection (e)), who are certified by a national certification organization. Certification by a nationally recognized organization provides a rigorous assessment of clinical knowledge and competence in practice that is critical for a leader of an NP educational program. National certification for the lead nurse practitioner and program director provides substantial credibility to the program that will be preparing future nurse practitioners. Most schools of nursing that offer nurse practitioner programs recruit leaders with national certification. California programs follow the Commission on Collegiate Nursing Education (CCNE) and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for program review that are already integrated into the national nursing education accreditation processes. The criteria have been established by national experts in NP education and reviewed by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the document and who support the requirement for national certification. These criteria are found in the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the requirement for national certification of lead faculty and directors of programs ACNL respectfully requests that the BRN require national certification for both the NP Program and Specialty Director(s). National certification will ensure the safety of our members, the current student population, future nursing students and our patients. If we can be of additional assistance, please contact me at 916-779-6949. Sincerely,

Patricia McFarland, MS, RN, FAAN CEO Association of California Nurse Leaders

i/ornia Association Clinical Nurse Specialists

November 25,2016

Ronnie Whitaker 1747 N. Market Blvd., Suite 150 Sacramento, CA, 95834 Ronnie.Whitabker@dc.ca.gov

Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification Dear California Board of Registered Nursing:

The California Association of Clinical Nurse Specialists acknowledges the Board of Registered Nursing for the work in revising and updating Title 16 regulations pertaining to nurse practitioners (NPs). The continuous evaluation of such matters are pertinent in keeping our communities throughout the state of California safe.

As advanced practice (AP) nurses working with our NP colleagues in academia, acute care, ambulatory and community settings we value the knowledge and expertise of our BRN-certified NPs. During clinical rotations NP students are receiving the benefits of preceptors hip from nationally certified NPs (as many employers are requiring APNs to have nationally certification for privileging or obtain one within the first year of employment).

The academic settings that are contributing to the preparation of future NPs should be held to the same standards; as such program and specialty directors should be nationally certified. It is important for our academic colleagues to also be up-to-date with the developments in practice as they prepare future practitioners, especially during such a dynamic health care setting. One of the important purposes of national certification is "demonstration of an individual's commitment to a profession and to lifelong learning" (ANCC statement on certification, 2010), program directors are one of the primary role models to uphold this value for NP students.

As the Board of Registered Nursing revises Title 16 regulations, it is also essential to keep in mind those educators/program/specialty directors that are currently in the role and consider grandfathering them in.

On behalf of the California Association of Clinical Nurse Specialists representing advanced practice nurses in the state, we strongly recommend that the BRN require national certification for both the Program and Specialty Director(s). Consistency in standardization in the preparation of academic and clinical NPs is key in mentoring the future workforce ofNPs.

Please feel free to contact if you have any questions.

Respectfull y,

~8 Lianna Z. Ansryan RN-BC, CNS,

President, California Association of Clinical Nurse Specialists

November 23, 2016 Ronnie Whitaker 1747 N. Market Blvd., Suite 150 Sacramento, CA 95834 Re: Nurse Practitioner Proposed Regulations for NP Program Directors and National Certification To Members of the Board of Registered Nursing, I am writing in support of updating California’s Board of Registered Nursing’s regulations to require that all Directors of NP programs in BRN approved programs be nationally certified in the area of specialty that they are Director over. This assures that the specialty NP Director is recertified via CEU updates on an ongoing basis and therefore not putting students at risk for not knowing the minimum competencies for that specialty. This also prevents potential risk for patients down the line of the care chain. As one of only two states left in the country to not require national specialty certification to practice (CA, KS), it is really quite an embarrassment that our standards are not of the highest. Since most insurers, Medicare and Medicaid mandate national certification of any NP for reimbursement purposes, this is a moot point and nearly all California NPs must have this for employment purposes, so the Directors of specialty programs should be held to these same standards. I am a Family Nurse Practitioner of 31 years experience and I am the current Director of the FNP program at Western University of Health Sciences, College of Graduate Nursing and the Assistant Dean of Distance Operations, and I hold national certification as an FNP from AACN. All of our students are required to take a National Certification exam (either ANCC or AANP), yet California’s regulations do not support this important standard. Please shore up this weak link in our regulatory requirements in California and make National Certification a requirement for Directors of Nurse Practitioner specialty programs in California schools. Thank you for your time in consideration of this important issue. Respectfully,

Diana Lithgow, PhD, FNP, RN-BCProfessor of NursingDirector FNP Program Director Ambulatory Care ProgramAssistant Dean of Distance OperationsCollege of Graduate NursingWestern University of Health Science909-469-5523 (CGN Office)DLithgow@WesternU.edu

November 28, 2016

Ronnie Whitaker

Regulations Coordinator Board of Registered Nursing

1747 N. Market Blvd, Ste. 150

Sacramento, CA 95834

Dear Members of the California Board of Registered Nurses

The California Association of Colleges of Nursing, the voice of California baccalaureate and

graduate nursing education, supports the language in the proposed regulations that would require

all Board-approved nurse practitioner education programs to have a lead nurse practitioner

faculty educator (subsection (d)(3)), and a nurse practitioner education program director

(subsection (e)), who are certified by a national certification organization.

Certification by a nationally recognized organization provides a rigorous assessment of clinical

knowledge and competence in practice that is critical for a leader of an NP educational program.

National certification for the lead nurse practitioner and program director provides substantial

credibility to the program that will be preparing future nurse practitioners.

Most schools of nursing that offer nurse practitioner programs recruit leaders with national

certification. Our programs follow the Commission on Collegiate Nursing Education (CCNE)

and National Organization of Nurse Practitioner Faculty (NONPF) evaluation criteria for

program review that are already integrated into the national nursing education accreditation

processes. The criteria have been established by national experts in NP education and reviewed

by a broader group of nurse practitioners with 480 nurse practitioners providing comments on the

document and who support the requirement for national certification. These criteria are found in

the document Criteria for Evaluation of Nurse Practitioner Programs and state specifically the

requirement for national certification of lead faculty and directors of programs

CACN urges you to consider adopting the proposed language.

Sincerely,

Philip A. Greiner, DNSc, RN

President

November 22, 2016 Board of Registered Nursing Nursing Practice Committee c/o Ronnie Whitaker 1747 N. Market Blvd., Suite 150 Sacramento, CA 95834 RE: Proposed Nurse Practitioner Regulations for Directors and National Certification To the Board of Registered Nursing, On behalf of the California Association for Nurse Practitioners (CANP), I write to express our appreciation for the California Board of Registered Nursing’s (BRN) efforts to update the Title 16 nurse practitioner regulations. CANP aligns itself with the position and comments of the California Action Coalition (CAC), submitted to the board in CAC’s recent letter on this issue, dated November 2016. Nurse practitioners (NPs) are advanced practice registered nurses who are licensed by the Board of Registered Nursing and have pursued higher education, either a master’s or doctoral degree, and certification as a NP. NPs play an important role in the healthcare delivery system and provide care in a variety of settings including hospitals, community clinics, and private practice settings, many of which are located in medically underserved communities. CANP was established over thirty years ago to represent nurse practitioners and their patients, working to remove unnecessary barriers to care and to protect and expand the practice of nurse practitioners. Like CAC, CANP believes that Program and Specialty Directors should receive national certification and should be required to complete 100 continuing education (CE) hours over five years in their certified population focus area, including 25 CEs in pharmacology. Requiring Program and Specialty Directors to be nationally certified will ensure NPs receive the proper training to provide direction and leadership within their respective specialties, and protect patients by ensuring appropriate training in pharmacotherapeutics. CANP commends the BRN’s efforts to revise the Title 16 NP regulations and, as stated above, recommends that both Program and Specialty Directors be required to be nationally certified. We believe this is consistent with our mission to allow NPs to play a broader role in the healthcare system and increase access to quality care. Please contact our Sacramento representative, Kristy Wiese with Capitol Advocacy, at (916) 444-0400 or kwiese@capitoladvocacy.com, if you have any questions. Sincerely,

Theresa Ullrich, MSN, FNP-C President cc: Susanne J. Phillips, DNP, APRN, FNP-BC, California Action Coalition Garrett Chan, PhD, APRN, ACNP-C, CNS-BC, FAAN, California Action Coalition

1415 L Street, Suite 1000 Sacramento, CA 95814 916 441-1361 O Ι 916 443-2004 F

canpweb.org

 

   November  24,  2016    Mr.  Ronnie  Whitaker  Administration  Unit  Board  of  Registered  Nursing  Department  of  Consumer  Affairs  Ronnie.Whitaker@dca.ca.gov    Re:  Nurse  Practitioner  Proposed  Regulations  for  Directors  and  National  Certification    Dear  Mr.  Whitaker:    The  California  Nurse-­‐Midwives  Association  (CNMA)  continues  to  be  in  support  of  revising  and  updating  the  Title  16  regulations  that  pertain  to  nurse  practitioners  (NPs).    This  is  an  important  step  forward  to  ensuring  that  California  regulations  stay  abreast  of  current  needs  in  an  ever-­‐changing  healthcare  environment.    The  BRN  recognized  both  nurse  practitioners  (NPs)  and  nurse-­‐midwives  as  “advanced  practice  registered  nurses  (APRN).”  CNMA  believes  that  regulations  related  to  NPs  help  raise  the  quality  and  standards  for  all  APRNs.  This  includes  the  quality  and  standards  that  are  set  by  requiring  national  certification;  national  certification  is  the  mark  of  public  safety  assurance  that  are  the  ultimate  responsibility  and  authority  of  licensing  boards.    There  are  differences  between  BRN  certification  and  national  certification  that  are  important  to  articulate.    BRN  certification  ensures  that  NPs  graduate  from  a  BRN-­‐approved  program.    BRN  certification  also  grants  authority  to  practice  and  title  protection.    Every  2  years,  BRN-­‐certified  NPs  are  required  to  have  30  continuing  education  (CE)  hours  to  ensure  the  NP  is  current  in  the  knowledge  and  practice  of  nursing  and  nurse  practitioner  practice.    To  be  certified  by  a  nationally-­‐recognized  certification  organization,  NPs  must  complete  100  CE  hours  over  5  years.    The  national  certification  requirement  is  25  CE  hours  above  the  BRN  requirement  for  the  same  time  frame  of  5  years.    In  addition,  the  CEs  must  be  completed  in  the  certified  population  focus  area  to  ensure  the  NP  is  current  in  trends  and  changes  in  practice.    Lastly,  of  the  100  CEs,  25  CEs  must  be  dedicated  to  pharmacology  as  pharmacotherapeutics  can  be  of  great  benefit  but  also  can  cause  great  harm.    Current  clinical  practice  or  re-­‐examination  is  also  required  for  recertification.  These  conditions  of  CE  and  either  practice  or  re-­‐examination  for  re-­‐certification  are  much  more  stringent  than  the  BRN  and  are  important  for  the  safe  practice  of  NPs.    Program  and  Specialty  Directors  of  BRN-­‐approved  nurse  practitioner  programs  should  be  nationally  certified  for  many  reasons.    First,  having  national  certification,  as  mentioned  above,  assures  that  the  Directors  are  keeping  up  with  trends  in  practice  and  pharmacology.    Second,  national  certification  for  Specialty  Directors  ensures  that  an  appropriately-­‐  trained  NP  is  providing  leadership  within  the  specialty.    The  proposed  regulations  are  drafted  to  ensure  the  safety  and  integrity  of  the  NP  and  of  graduates.    On  behalf  of  the  California  Nurse-­‐Midwives  Association,  representing  over  1200  professional  nurse-­‐midwives  and  nurse-­‐midwife  faculty  in  California,  we  strongly  recommend  that  the  BRN  require  national  certification  for  both  the  Program  and  Specialty  Director(s).    This  will  ensure  the  safety  of  students  and  patients.    Please  feel  free  to  contact  us  if  you  have  any  questions.    Sincerely,  

 Kim  Q.  Dau,  CNM  Chair,  Health  Policy  Committee  California  Nurse-­‐Midwives  Association  

BOARD OF REGISTERED NURSING Nursing Practice Committee

Agenda Item Summary

AGENDA ITEM: 10.2 DATE: March 8, 2017

ACTION REQUESTED: Information Only: Epinephrine Auto Injectors: “Authorized Entity”

REQUESTED BY: Trande Phillips RN

Chair Practice Committee

BACKGROUND: Authorized entity” means any for profit, nonprofit, or governmental entity or organization that employs at least one person or utilizes at least one volunteer or agent that has voluntarily completed training course to administer epinephrine auto-injector. “Authorized entity,” trained individual may use an epinephrine auto-injector to render emergency care to another person in accordance with these provisions. The law would also authorize a pharmacy to furnish epinephrine auto-injectors to an authorized entity, The law would require an authorized entity to create and maintain a specified operations plan relating to its use of epinephrine auto-injectors, and would require those entities to submit a report to the Emergency Medical Services Authority of each incident that involves the administration of an epinephrine auto-injector, not more than 30 days after each use. The law would also require the authority to publish an annual report summarizing the reports submitted to the authority pursuant to the law provisions. NEXT STEPS: Place on Board agenda. FISCAL IMPACT, IF ANY: PERSON(S) TO CONTACT:

Janette Wackerly, MBA, BSN, RN Supervising Nursing Education Consultant Janette.Wackerly@dca.ca.gov (916) 574-7686

Assembly Bill No. 1386

CHAPTER 374

An act to add Section 4119.4 to the Business and Professions Code, toamend Section 1714.23 of the Civil Code, to amend Section 49414 of theEducation Code, and to amend Section 1797.197a of the Health and SafetyCode, relating to emergency medical care.

[Approved by Governor September 16, 2016. Filed withSecretary of State September 16, 2016.]

legislative counsel’s digest

AB 1386, Low. Emergency medical care: epinephrine auto-injectors.(1)  Existing law authorizes a prehospital emergency medical care person,

first responder, or lay rescuer to use an epinephrine auto-injector to renderemergency care to another person, as specified. Existing law requires theEmergency Medical Services Authority to approve authorized trainingproviders and the minimum standards for training and the use andadministration of epinephrine auto-injectors. The existing Pharmacy Lawalso authorizes a pharmacy to dispense epinephrine auto-injectors to aprehospital emergency medical care person, first responder, or lay rescuerfor the purpose of rendering emergency care in accordance with theseprovisions. A violation of the Pharmacy Law is a crime. Existing law requiresschool districts, county offices of education, and charter schools to provideemergency epinephrine auto-injectors, as defined, to school nurses andtrained personnel who have volunteered to use epinephrine auto-injectorsunder emergency circumstances, as specified, and authorizes school nursesand trained personnel to use epinephrine auto-injectors to provide emergencymedical aid to persons suffering, or reasonably believed to be suffering,from an anaphylactic reaction.

This bill would permit an “authorized entity,” as defined, to use anepinephrine auto-injector to render emergency care to another person inaccordance with these provisions. The bill would also authorize a pharmacyto furnish epinephrine auto-injectors to an authorized entity, as provided.Because a violation of these provisions would be a crime, the bill wouldimpose a state-mandated local program. The bill would require an authorizedentity to create and maintain a specified operations plan relating to its useof epinephrine auto-injectors, and would require those entities to submit areport to the Emergency Medical Services Authority of each incident thatinvolves the administration of an epinephrine auto-injector, not more than30 days after each use. The bill would also require the authority to publishan annual report summarizing the reports submitted to the authority pursuantto the bill’s provisions. The bill would define the term “epinephrine

89

auto-injector” for purposes of these provisions and other related provisionsthat authorize the use of epinephrine auto-injectors, as specified.

(2)  Under existing law, everyone is generally responsible, not only forthe result of his or her willful acts, but also for an injury occasioned toanother by his or her want of ordinary care or skill in the management ofhis or her property or person, except so far as the latter has, willfully or bywant of ordinary care, brought the injury upon himself or herself. Existinglaw also provides that a prehospital emergency care person, first responder,or lay rescuer who administers an epinephrine auto-injector to another personwho appears to be experiencing anaphylaxis at the scene of an emergencysituation, in good faith and not for compensation, is not liable for any civildamages resulting from his or her acts or omissions in administering theepinephrine auto-injector, if that person has complied with specifiedcertification and training requirements and standards.

This bill would provide that an authorized entity is not liable for any civildamages resulting from any act or omission connected to the administrationof an epinephrine auto-injector, as specified. The bill would also exemptan authorizing physician and surgeon from certain sanctions for the issuanceof an epinephrine auto-injector under those provisions, except as specified.

(3)  The California Constitution requires the state to reimburse localagencies and school districts for certain costs mandated by the state. Statutoryprovisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act fora specified reason.

The people of the State of California do enact as follows:

SECTION 1. Section 4119.4 is added to the Business and ProfessionsCode, to read:

4119.4. (a)  Notwithstanding any other law, a pharmacy may furnishepinephrine auto-injectors to an authorized entity, for the purpose ofrendering emergency care in accordance with Section 1797.197a of theHealth and Safety Code, if both of the following requirements are met:

(1)  The epinephrine auto-injectors are furnished exclusively for use by,or in connection with, an authorized entity.

(2)  An authorized health care provider provides a prescription thatspecifies the quantity of epinephrine auto-injectors to be furnished to anauthorized entity described in subdivision (a) of Section 1797.197a of theHealth and Safety Code. A new prescription shall be written for anyadditional epinephrine auto-injectors required for use.

(b)  The pharmacy shall label each epinephrine auto-injector dispensedwith all of the following:

(1)  The name of the person or entity to whom the prescription was issued.(2)  The designations “Section 1797.197a Responder” and “First Aid

Purposes Only.”(3)  The dosage, use, and expiration date.

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— 2 —Ch. 374

(c)  Each dispensed prescription shall include the manufacturer’s productinformation sheet for the epinephrine auto-injector.

(d)  Records regarding the acquisition and disposition of epinephrineauto-injectors furnished pursuant to subdivision (a) shall be maintained bythe authorized entity for a period of three years from the date the recordswere created. The authorized entity shall be responsible for monitoring thesupply of epinephrine auto-injectors and ensuring the destruction of expiredepinephrine auto-injectors.

(e)  The epinephrine auto-injector dispensed pursuant to this section maybe used only for the purpose, and under the circumstances, described inSection 1797.197a of the Health and Safety Code.

(f)  For purposes of this section, “epinephrine auto-injector” means adisposable delivery device designed for the automatic injection of apremeasured dose of epinephrine into the human body to prevent or treat alife-threatening allergic reaction.

SEC. 2. Section 1714.23 of the Civil Code is amended to read:1714.23. (a)  For purposes of this section, the following definitions shall

apply:(1)  “Anaphylaxis” means a potentially life-threatening hypersensitivity

or allergic reaction to a substance.(A)  Symptoms of anaphylaxis may include shortness of breath, wheezing,

difficulty breathing, difficulty talking or swallowing, hives, itching, swelling,shock, or asthma.

(B)  Causes of anaphylaxis may include, but are not limited to, insectstings or bites, foods, drugs, and other allergens, as well as idiopathic orexercise-induced anaphylaxis.

(2)  “Epinephrine auto-injector” means a disposable delivery devicedesigned for the automatic injection of a premeasured dose of epinephrineinto the human body to prevent or treat a life-threatening allergic reaction.

(b)  (1)  Any person described in subdivision (b) of Section 1797.197aof the Health and Safety Code who administers an epinephrine auto-injector,in good faith and not for compensation, to another person who appears tobe experiencing anaphylaxis at the scene of an emergency situation is notliable for any civil damages resulting from his or her acts or omissions inadministering the epinephrine auto-injector, if that person has compliedwith the requirements and standards of Section 1797.197a of the Health andSafety Code.

(2)  (A)  An authorized entity shall not be liable for any civil damagesresulting from any act or omission other than an act or omission constitutinggross negligence or willful or wanton misconduct connected to theadministration of an epinephrine auto-injector by any one of its employees,volunteers, or agents who is a lay rescuer, as defined by paragraph (4) ofsubdivision (a) of Section 1797.197a of the Health and Safety Code, if theentity has complied with all applicable requirements of Section 1797.197aof the Health and Safety Code.

(B)  The failure of an authorized entity to possess or administer anepinephrine auto-injector shall not result in civil liability.

89

Ch. 374— 3 —

(3)  This subdivision does not affect any other immunity or defense thatis available under law.

(c)  The protection specified in paragraph (1) of subdivision (b) shall notapply in a case of personal injury or wrongful death that results from thegross negligence or willful or wanton misconduct of the person who rendersemergency care treatment by the use of an epinephrine auto-injector.

(d)  Nothing in this section relieves a manufacturer, designer, developer,distributor, or supplier of an epinephrine auto-injector of liability under anyother applicable law.

(e)  An authorizing physician and surgeon is not subject to professionalreview, liable in a civil action, or subject to criminal prosecution for theissuance of a prescription or order in accordance with Section 1797.197aof the Health and Safety Code unless the physician and surgeon’s issuanceof the prescription or order constitutes gross negligence or willful ormalicious conduct.

SEC. 3. Section 49414 of the Education Code is amended to read:49414. (a)  School districts, county offices of education, and charter

schools shall provide emergency epinephrine auto-injectors to school nursesor trained personnel who have volunteered pursuant to subdivision (d), andschool nurses or trained personnel may use epinephrine auto-injectors toprovide emergency medical aid to persons suffering, or reasonably believedto be suffering, from an anaphylactic reaction.

(b)  For purposes of this section, the following terms have the followingmeanings:

(1)  “Anaphylaxis” means a potentially life-threatening hypersensitivityto a substance.

(A)  Symptoms of anaphylaxis may include shortness of breath, wheezing,difficulty breathing, difficulty talking or swallowing, hives, itching, swelling,shock, or asthma.

(B)  Causes of anaphylaxis may include, but are not limited to, an insectsting, food allergy, drug reaction, and exercise.

(2)  “Authorizing physician and surgeon” may include, but is not limitedto, a physician and surgeon employed by, or contracting with, a localeducational agency, a medical director of the local health department, or alocal emergency medical services director.

(3)  “Epinephrine auto-injector” means a disposable delivery devicedesigned for the automatic injection of a premeasured dose of epinephrineinto the human body to prevent or treat a life-threatening allergic reaction.

(4)  “Qualified supervisor of health” may include, but is not limited to, aschool nurse.

(5)  “Volunteer” or “trained personnel” means an employee who hasvolunteered to administer epinephrine auto-injectors to a person if the personis suffering, or reasonably believed to be suffering, from anaphylaxis, hasbeen designated by a school, and has received training pursuant tosubdivision (d).

(c)  Each private elementary and secondary school in the state mayvoluntarily determine whether or not to make emergency epinephrine

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— 4 —Ch. 374

auto-injectors and trained personnel available at its school. In making thisdetermination, a school shall evaluate the emergency medical response timeto the school and determine whether initiating emergency medical servicesis an acceptable alternative to epinephrine auto-injectors and trainedpersonnel. A private elementary or secondary school choosing to exercisethe authority provided under this subdivision shall not receive state fundsspecifically for purposes of this subdivision.

(d)  Each public and private elementary and secondary school in the statemay designate one or more volunteers to receive initial and annual refreshertraining, based on the standards developed pursuant to subdivision (e),regarding the storage and emergency use of an epinephrine auto-injectorfrom the school nurse or other qualified person designated by an authorizingphysician and surgeon.

(e)  (1)  Every five years, or sooner as deemed necessary by theSuperintendent, the Superintendent shall review minimum standards oftraining for the administration of epinephrine auto-injectors that satisfy therequirements of paragraph (2). For purposes of this subdivision, theSuperintendent shall consult with organizations and providers with expertisein administering epinephrine auto-injectors and administering medicationin a school environment, including, but not limited to, the State Departmentof Public Health, the Emergency Medical Services Authority, the AmericanAcademy of Allergy, Asthma and Immunology, the California School NursesOrganization, the California Medical Association, the American Academyof Pediatrics, Food Allergy Research and Education, the California Societyof Allergy, Asthma and Immunology, the American College of Allergy,Asthma and Immunology, the Sean N. Parker Center for Allergy Research,and others.

(2)  Training established pursuant to this subdivision shall include all ofthe following:

(A)  Techniques for recognizing symptoms of anaphylaxis.(B)  Standards and procedures for the storage, restocking, and emergency

use of epinephrine auto-injectors.(C)  Emergency followup procedures, including calling the emergency

911 telephone number and contacting, if possible, the pupil’s parent andphysician.

(D)  Recommendations on the necessity of instruction and certificationin cardiopulmonary resuscitation.

(E)  Instruction on how to determine whether to use an adult epinephrineauto-injector or a junior epinephrine auto-injector, which shall includeconsideration of a pupil’s grade level or age as a guideline of equivalencyfor the appropriate pupil weight determination.

(F)  Written materials covering the information required under thissubdivision.

(3)  Training established pursuant to this subdivision shall be consistentwith the most recent Voluntary Guidelines for Managing Food Allergies InSchools and Early Care and Education Programs published by the federal

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Ch. 374— 5 —

Centers for Disease Control and Prevention and the most recent guidelinesfor medication administration issued by the department.

(4)  A school shall retain for reference the written materials preparedunder subparagraph (F) of paragraph (2).

(f)  A school district, county office of education, or charter school shalldistribute a notice at least once per school year to all staff that contains thefollowing information:

(1)  A description of the volunteer request stating that the request is forvolunteers to be trained to administer an epinephrine auto-injector to aperson if the person is suffering, or reasonably believed to be suffering,from anaphylaxis, as specified in subdivision (b).

(2)  A description of the training that the volunteer will receive pursuantto subdivision (d).

(g)  (1)  A qualified supervisor of health at a school district, county officeof education, or charter school shall obtain from an authorizing physicianand surgeon a prescription for each school for epinephrine auto-injectorsthat, at a minimum, includes, for elementary schools, one regular epinephrineauto-injector and one junior epinephrine auto-injector, and for junior highschools, middle schools, and high schools, if there are no pupils who requirea junior epinephrine auto-injector, one regular epinephrine auto-injector. Aqualified supervisor of health at a school district, county office of education,or charter school shall be responsible for stocking the epinephrineauto-injector and restocking it if it is used.

(2)  If a school district, county office of education, or charter school doesnot have a qualified supervisor of health, an administrator at the schooldistrict, county office of education, or charter school shall carry out theduties specified in paragraph (1).

(3)  A prescription pursuant to this subdivision may be filled by local ormail order pharmacies or epinephrine auto-injector manufacturers.

(4)  An authorizing physician and surgeon shall not be subject toprofessional review, be liable in a civil action, or be subject to criminalprosecution for the issuance of a prescription or order pursuant to this section,unless the physician and surgeon’s issuance of the prescription or orderconstitutes gross negligence or willful or malicious conduct.

(h)  A school nurse or, if the school does not have a school nurse or theschool nurse is not onsite or available, a volunteer may administer anepinephrine auto-injector to a person exhibiting potentially life-threateningsymptoms of anaphylaxis at school or a school activity when a physicianis not immediately available. If the epinephrine auto-injector is used it shallbe restocked as soon as reasonably possible, but no later than two weeksafter it is used. Epinephrine auto-injectors shall be restocked before theirexpiration date.

(i)  A volunteer shall initiate emergency medical services or otherappropriate medical followup in accordance with the training materialsretained pursuant to paragraph (4) of subdivision (e).

(j)  A school district, county office of education, or charter school shallensure that each employee who volunteers under this section will be provided

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defense and indemnification by the school district, county office ofeducation, or charter school for any and all civil liability, in accordancewith, but not limited to, that provided in Division 3.6 (commencing withSection 810) of Title 1 of the Government Code. This information shall bereduced to writing, provided to the volunteer, and retained in the volunteer’spersonnel file.

(k)  A state agency, the department, or a public school may accept gifts,grants, and donations from any source for the support of the public schoolcarrying out the provisions of this section, including, but not limited to, theacceptance of epinephrine auto-injectors from a manufacturer or wholesaler.

SEC. 4. Section 1797.197a of the Health and Safety Code is amendedto read:

1797.197a. (a)  For purposes of this section, the following definitionsshall apply:

(1)  “Anaphylaxis” means a potentially life-threatening hypersensitivityor allergic reaction to a substance.

(A)  Symptoms of anaphylaxis may include shortness of breath, wheezing,difficulty breathing, difficulty talking or swallowing, hives, itching, swelling,shock, or asthma.

(B)  Causes of anaphylaxis may include, but are not limited to, insectstings or bites, foods, drugs, and other allergens, as well as idiopathic orexercise-induced anaphylaxis.

(2)  “Authorized entity” means any for-profit, nonprofit, or governmententity or organization that employs at least one person or utilizes at leastone volunteer or agent that has voluntarily completed a training course asdescribed in subdivision (c).

(3)  “Epinephrine auto-injector” means a disposable delivery devicedesigned for the automatic injection of a premeasured dose of epinephrineinto the human body to prevent or treat a life-threatening allergic reaction.

(4)  “Lay rescuer” means any person who has met the training standardsand other requirements of this section but who is not otherwise licensed orcertified to use an epinephrine auto-injector on another person.

(5)  “Prehospital emergency medical care person” has the same meaningas defined in paragraph (2) of subdivision (a) of Section 1797.189.

(b)  A prehospital emergency medical care person or lay rescuer may usean epinephrine auto-injector to render emergency care to another person ifall of the following requirements are met:

(1)  The epinephrine auto-injector is legally obtained by prescription froman authorized health care provider or from an authorized entity that acquiredthe epinephrine auto-injector pursuant to subdivision (e).

(2)  The epinephrine auto-injector is used on another, with the expressedor implied consent of that person, to treat anaphylaxis.

(3)  The epinephrine auto-injector is stored and maintained as directedby the manufacturer’s instructions for that product.

(4)  The person using the epinephrine auto-injector has successfullycompleted a course of training with an authorized training provider, as

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described in subdivision (c), and has current certification of training issuedby the provider.

(5)  The epinephrine auto-injectors obtained by prehospital emergencymedical care personnel pursuant to Section 4119.3 of the Business andProfessions Code shall be used only when functioning outside the courseof the person’s occupational duties, or as a volunteer, pursuant to this section.

(6)  The Emergency Medical Services System is activated as soon aspracticable when an epinephrine auto-injector is used.

(c)  (1)  The authorized training providers shall be approved, and theminimum standards for training and the use and administration ofepinephrine auto-injectors pursuant to this section shall be established andapproved, by the authority. The authority may designate existing trainingstandards for the use and administration of epinephrine auto-injectors byprehospital emergency medical care personnel to satisfy the requirementsof this section.

(2)  The minimum training and requirements shall include all of thefollowing components:

(A)  Techniques for recognizing circumstances, signs, and symptoms ofanaphylaxis.

(B)  Standards and procedures for proper storage and emergency use ofepinephrine auto-injectors.

(C)  Emergency followup procedures, including activation of theEmergency Medical Services System, by calling the emergency 9-1-1telephone number or otherwise alerting and summoning more advancedmedical personnel and services.

(D)  Compliance with all regulations governing the training, indications,use, and precautions concerning epinephrine auto-injectors.

(E)  Written material covering the information required under thisprovision, including the manufacturer product information sheets oncommonly available models of epinephrine auto-injectors.

(F)  Completion of a training course in cardiopulmonary resuscitationand the use of an automatic external defibrillator (AED) for infants, children,and adults that complies with regulations adopted by the authority and thestandards of the American Heart Association or the American Red Cross,and a current certification for that training.

(3)  Training certification shall be valid for no more than two years, afterwhich recertification with an authorized training provider is required.

(4)  The director may, in accordance with regulations adopted by theauthority, deny, suspend, or revoke any approval issued under thissubdivision or may place any approved training provider on probation upona finding by the director of an imminent threat to public health and safety,as evidenced by any of the following:

(A)  Fraud.(B)  Incompetence.(C)  The commission of any fraudulent, dishonest, or corrupt act that is

substantially related to the qualifications, functions, or duties of trainingprogram directors or instructors.

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(D)  Conviction of any crime that is substantially related to thequalifications, functions, or duties of training program directors orinstructors. The record of conviction or a certified copy of the record shallbe conclusive evidence of the conviction.

(E)  Violating or attempting to violate, directly or indirectly, or assistingin or abetting the violation of, or conspiring to violate, any provision of thissection or the regulations promulgated by the authority pertaining to thereview and approval of training programs in anaphylaxis and the use andadministration of epinephrine auto-injectors, as described in this subdivision.

(d)  (1)  The authority shall assess a fee pursuant to regulation sufficientto cover the reasonable costs incurred by the authority for the ongoing reviewand approval of training and certification under subdivision (c).

(2)  The fees shall be deposited in the Specialized First Aid TrainingProgram Approval Fund, which is hereby created in the State Treasury. Allmoneys deposited in the fund shall be made available, upon appropriation,to the authority for purposes described in paragraph (1).

(3)  The authority may transfer unused portions of the Specialized FirstAid Training Program Approval Fund to the Surplus Money InvestmentFund. Funds transferred to the Surplus Money Investment Fund shall beplaced in a separate trust account, and shall be available for transfer to theSpecialized First Aid Training Program Approval Fund, together with theinterest earned, when requested by the authority.

(4)  The authority shall maintain a reserve balance in the Specialized FirstAid Training Program Approval Fund of 5 percent of annual revenues. Anyincrease in the fees deposited in the Specialized First Aid Training ProgramApproval Fund shall be effective upon determination by the authority thatadditional moneys are required to fund expenditures pursuant to subdivision(c).

(e)  (1)  An authorized health care provider may issue a prescription foran epinephrine auto-injector to a prehospital emergency medical care personor a lay rescuer for the purpose of rendering emergency care to anotherperson upon presentation of a current epinephrine auto-injector certificationcard issued by the authority demonstrating that the person is trained andqualified to administer an epinephrine auto-injector pursuant to this sectionor any other law.

(2)  An authorized health care provider may issue a prescription for anepinephrine auto-injector to an authorized entity if the authorized entitysubmits evidence it employs at least one person, or utilizes at least onevolunteer or agent, who is trained and has a current epinephrine auto-injectorcertification card issued by the authority demonstrating that the person isqualified to administer an epinephrine auto-injector pursuant to this section.

(f)  An authorized entity that possesses and makes available epinephrineauto-injectors shall do both of the following:

(1)  Create and maintain on its premises an operations plan that includesall of the following:

(A)  The name and contact number for the authorized health care providerwho prescribed the epinephrine auto-injector.

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(B)  Where and how the epinephrine auto-injector will be stored.(C)  The names of the designated employees or agents who have

completed the training program required by this section and who areauthorized to administer the epinephrine auto-injector.

(D)  How and when the epinephrine auto-injector will be inspected foran expiration date.

(E)  The process to replace the expired epinephrine auto-injector, includingthe proper disposal of the expired epinephrine auto-injector or usedepinephrine auto-injector in a sharps container.

(2)  Submit to the authority, in a manner identified by the authority, areport of each incident that involves the use of an epinephrine auto-injector,not more than 30 days after each use. The authority shall annually publisha report that summarizes all reports submitted to it under this subdivision.

(g)  This section shall not apply to a school district or county office ofeducation, or its personnel, that provides and utilizes epinephrineauto-injectors to provide emergency medical aid pursuant to Section 49414of the Education Code.

(h)  This section shall not be construed to limit or restrict the ability ofprehospital emergency medical care personnel, under any other statute orregulation, to administer epinephrine, including the use of epinephrineauto-injectors, or to require additional training or certification beyond whatis already required under the other statute or regulation.

SEC. 5. No reimbursement is required by this act pursuant to Section 6of Article XIII B of the California Constitution because the only costs thatmay be incurred by a local agency or school district will be incurred becausethis act creates a new crime or infraction, eliminates a crime or infraction,or changes the penalty for a crime or infraction, within the meaning ofSection 17556 of the Government Code, or changes the definition of a crimewithin the meaning of Section 6 of Article XIII B of the CaliforniaConstitution.

O

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Assembly Bill No. 1386

CHAPTER 374

An act to add Section 4119.4 to the Business and Professions Code, to amend Section 1714.23 of the Civil Code, to amend Section 49414 of the Education Code, and to amend Section 1797.197a of the Health and Safety Code, relating to emergency medical care.

[Approved by Governor September 16, 2016. Filed with Secretary of State September 16, 2016.]

legislative counsel’s digest

AB 1386, Low. Emergency medical care: epinephrine auto-injectors. (1) Existing law authorizes a prehospital emergency medical care person,

first responder, or lay rescuer to use an epinephrine auto-injector to render emergency care to another person, as specified. Existing law requires the Emergency Medical Services Authority to approve authorized training providers and the minimum standards for training and the use and administration of epinephrine auto-injectors. The existing Pharmacy Law also authorizes a pharmacy to dispense epinephrine auto-injectors to a prehospital emergency medical care person, first responder, or lay rescuer for the purpose of rendering emergency care in accordance with these provisions. A violation of the Pharmacy Law is a crime. Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors, as defined, to school nurses and trained personnel who have volunteered to use epinephrine auto-injectors under emergency circumstances, as specified, and authorizes school nurses and trained personnel to use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction.

This bill would permit an “authorized entity,” as defined, to use an epinephrine auto-injector to render emergency care to another person in accordance with these provisions. The bill would also authorize a pharmacy to furnish epinephrine auto-injectors to an authorized entity, as provided. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. The bill would require an authorized entity to create and maintain a specified operations plan relating to its use of epinephrine auto-injectors, and would require those entities to submit a report to the Emergency Medical Services Authority of each incident that involves the administration of an epinephrine auto-injector, not more than 30 days after each use. The bill would also require the authority to publish an annual report summarizing the reports submitted to the authority pursuant to the bill’s provisions. The bill would define the term “epinephrine

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Ch. 374 — 2 —

auto-injector” for purposes of these provisions and other related provisions that authorize the use of epinephrine auto-injectors, as specified.

(2) Under existing law, everyone is generally responsible, not only for the result of his or her willful acts, but also for an injury occasioned to another by his or her want of ordinary care or skill in the management of his or her property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon himself or herself. Existing law also provides that a prehospital emergency care person, first responder, or lay rescuer who administers an epinephrine auto-injector to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation, in good faith and not for compensation, is not liable for any civil damages resulting from his or her acts or omissions in administering the epinephrine auto-injector, if that person has complied with specified certification and training requirements and standards.

This bill would provide that an authorized entity is not liable for any civil damages resulting from any act or omission connected to the administration of an epinephrine auto-injector, as specified. The bill would also exempt an authorizing physician and surgeon from certain sanctions for the issuance of an epinephrine auto-injector under those provisions, except as specified.

(3) The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

The people of the State of California do enact as follows:

SECTION 1. Section 4119.4 is added to the Business and Professions

Code, to read: 4119.4. (a) Notwithstanding any other law, a pharmacy may furnish

epinephrine auto-injectors to an authorized entity, for the purpose of rendering emergency care in accordance with Section 1797.197a of the Health and Safety Code, if both of the following requirements are met:

(1) The epinephrine auto-injectors are furnished exclusively for use by, or in connection with, an authorized entity.

(2) An authorized health care provider provides a prescription that specifies the quantity of epinephrine auto-injectors to be furnished to an authorized entity described in subdivision (a) of Section 1797.197a of the Health and Safety Code. A new prescription shall be written for any additional epinephrine auto-injectors required for use.

(b) The pharmacy shall label each epinephrine auto-injector dispensed with all of the following:

(1) The name of the person or entity to whom the prescription was issued. (2) The designations “Section 1797.197a Responder” and “First Aid

Purposes Only.” (3) The dosage, use, and expiration date.

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(c) Each dispensed prescription shall include the manufacturer’s product information sheet for the epinephrine auto-injector.

(d) Records regarding the acquisition and disposition of epinephrine auto-injectors furnished pursuant to subdivision (a) shall be maintained by the authorized entity for a period of three years from the date the records were created. The authorized entity shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors.

(e) The epinephrine auto-injector dispensed pursuant to this section may be used only for the purpose, and under the circumstances, described in Section 1797.197a of the Health and Safety Code.

(f) For purposes of this section, “epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.

SEC. 2. Section 1714.23 of the Civil Code is amended to read: 1714.23. (a) For purposes of this section, the following defi shall

apply: (1) “Anaphylaxis” means a potentially life-threatening hypersensitivity

or allergic reaction to a substance. (A) Symptoms of anaphylaxis may include shortness of breath, wheezing,

diffi breathing, diffi talking or swallowing, hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to, insect stings or bites, foods, drugs, and other allergens, as well as idiopathic or exercise-induced anaphylaxis.

(2) “Epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.

(b) (1) Any person described in subdivision (b) of Section 1797.197a of the Health and Safety Code who administers an epinephrine auto-injector, in good faith and not for compensation, to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation is not liable for any civil damages resulting from his or her acts or omissions in administering the epinephrine auto-injector, if that person has complied with the requirements and standards of Section 1797.197a of the Health and Safety Code.

(2) (A) An authorized entity shall not be liable for any civil damages resulting from any act or omission other than an act or omission constituting gross negligence or willful or wanton misconduct connected to the administration of an epinephrine auto-injector by any one of its employees, volunteers, or agents who is a lay rescuer, as defined by paragraph (4) of subdivision (a) of Section 1797.197a of the Health and Safety Code, if the entity has complied with all applicable requirements of Section 1797.197a of the Health and Safety Code.

(B) The failure of an authorized entity to possess or administer an epinephrine auto-injector shall not result in civil liability.

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(3) This subdivision does not affect any other immunity or defense that is available under law.

(c) The protection specified in paragraph (1) of subdivision (b) shall not apply in a case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person who renders emergency care treatment by the use of an epinephrine auto-injector.

(d) Nothing in this section relieves a manufacturer, designer, developer, distributor, or supplier of an epinephrine auto-injector of liability under any other applicable law.

(e) An authorizing physician and surgeon is not subject to professional review, liable in a civil action, or subject to criminal prosecution for the issuance of a prescription or order in accordance with Section 1797.197a of the Health and Safety Code unless the physician and surgeon’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

SEC. 3. Section 49414 of the Education Code is amended to read: 49414. (a) School districts, county offices of education, and charter

schools shall provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered pursuant to subdivision (d), and school nurses or trained personnel may use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction.

(b) For purposes of this section, the following terms have the following meanings:

(1) “Anaphylaxis” means a potentially life-threatening hypersensitivity to a substance.

(A) Symptoms of anaphylaxis may include shortness of breath, wheezing, diffi breathing, diffi talking or swallowing, hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to, an insect sting, food allergy, drug reaction, and exercise.

(2) “Authorizing physician and surgeon” may include, but is not limited to, a physician and surgeon employed by, or contracting with, a local educational agency, a medical director of the local health department, or a local emergency medical services director.

(3) “Epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.

(4) “Qualified supervisor of health” may include, but is not limited to, a school nurse.

(5) “Volunteer” or “trained personnel” means an employee who has volunteered to administer epinephrine auto-injectors to a person if the person is suffering, or reasonably believed to be suffering, from anaphylaxis, has been designated by a school, and has received training pursuant to subdivision (d).

(c) Each private elementary and secondary school in the state may voluntarily determine whether or not to make emergency epinephrine

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auto-injectors and trained personnel available at its school. In making this determination, a school shall evaluate the emergency medical response time to the school and determine whether initiating emergency medical services is an acceptable alternative to epinephrine auto-injectors and trained personnel. A private elementary or secondary school choosing to exercise the authority provided under this subdivision shall not receive state funds specifically for purposes of this subdivision.

(d) Each public and private elementary and secondary school in the state may designate one or more volunteers to receive initial and annual refresher training, based on the standards developed pursuant to subdivision (e), regarding the storage and emergency use of an epinephrine auto-injector from the school nurse or other qualifi person designated by an authorizing physician and surgeon.

(e) (1) Every five years, or sooner as deemed necessary by the Superintendent, the Superintendent shall review minimum standards of training for the administration of epinephrine auto-injectors that satisfy the requirements of paragraph (2). For purposes of this subdivision, the Superintendent shall consult with organizations and providers with expertise in administering epinephrine auto-injectors and administering medication in a school environment, including, but not limited to, the State Department of Public Health, the Emergency Medical Services Authority, the American Academy of Allergy, Asthma and Immunology, the California School Nurses Organization, the California Medical Association, the American Academy of Pediatrics, Food Allergy Research and Education, the California Society of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, the Sean N. Parker Center for Allergy Research, and others.

(2) Training established pursuant to this subdivision shall include all of the following:

(A) Techniques for recognizing symptoms of anaphylaxis. (B) Standards and procedures for the storage, restocking, and emergency

use of epinephrine auto-injectors. (C) Emergency followup procedures, including calling the emergency

911 telephone number and contacting, if possible, the pupil’s parent and physician.

(D) Recommendations on the necessity of instruction and certification in cardiopulmonary resuscitation.

(E) Instruction on how to determine whether to use an adult epinephrine auto-injector or a junior epinephrine auto-injector, which shall include consideration of a pupil’s grade level or age as a guideline of equivalency for the appropriate pupil weight determination.

(F) Written materials covering the information required under this subdivision.

(3) Training established pursuant to this subdivision shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies In Schools and Early Care and Education Programs published by the federal

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Centers for Disease Control and Prevention and the most recent guidelines for medication administration issued by the department.

(4) A school shall retain for reference the written materials prepared under subparagraph (F) of paragraph (2).

(f) A school district, county office of education, or charter school shall distribute a notice at least once per school year to all staff that contains the following information:

(1) A description of the volunteer request stating that the request is for volunteers to be trained to administer an epinephrine auto-injector to a person if the person is suffering, or reasonably believed to be suffering, from anaphylaxis, as specified in subdivision (b).

(2) A description of the training that the volunteer will receive pursuant to subdivision (d).

(g) (1) A qualified supervisor of health at a school district, county office of education, or charter school shall obtain from an authorizing physician and surgeon a prescription for each school for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high schools, middle schools, and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. A qualifi supervisor of health at a school district, county offi of education, or charter school shall be responsible for stocking the epinephrine auto-injector and restocking it if it is used.

(2) If a school district, county office of education, or charter school does not have a qualified supervisor of health, an administrator at the school district, county office of education, or charter school shall carry out the duties specified in paragraph (1).

(3) A prescription pursuant to this subdivision may be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers.

(4) An authorizing physician and surgeon shall not be subject to professional review, be liable in a civil action, or be subject to criminal prosecution for the issuance of a prescription or order pursuant to this section, unless the physician and surgeon’s issuance of the prescription or order constitutes gross negligence or willful or malicious conduct.

(h) A school nurse or, if the school does not have a school nurse or the school nurse is not onsite or available, a volunteer may administer an epinephrine auto-injector to a person exhibiting potentially life-threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available. If the epinephrine auto-injector is used it shall be restocked as soon as reasonably possible, but no later than two weeks after it is used. Epinephrine auto-injectors shall be restocked before their expiration date.

(i) A volunteer shall initiate emergency medical services or other appropriate medical followup in accordance with the training materials retained pursuant to paragraph (4) of subdivision (e).

(j) A school district, county office of education, or charter school shall ensure that each employee who volunteers under this section will be provided

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defense and indemnification by the school district, county office of education, or charter school for any and all civil liability, in accordance with, but not limited to, that provided in Division 3.6 (commencing with Section 810) of Title 1 of the Government Code. This information shall be reduced to writing, provided to the volunteer, and retained in the volunteer’s personnel file.

(k) A state agency, the department, or a public school may accept gifts, grants, and donations from any source for the support of the public school carrying out the provisions of this section, including, but not limited to, the acceptance of epinephrine auto-injectors from a manufacturer or wholesaler.

SEC. 4. Section 1797.197a of the Health and Safety Code is amended to read:

1797.197a. (a) For purposes of this section, the following definitions shall apply:

(1) “Anaphylaxis” means a potentially life-threatening hypersensitivity or allergic reaction to a substance.

(A) Symptoms of anaphylaxis may include shortness of breath, wheezing, diffi breathing, diffi talking or swallowing, hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to, insect stings or bites, foods, drugs, and other allergens, as well as idiopathic or exercise-induced anaphylaxis.

(2) “Authorized entity” means any for-profit, nonprofit, or government entity or organization that employs at least one person or utilizes at least one volunteer or agent that has voluntarily completed a training course as described in subdivision (c).

(3) “Epinephrine auto-injector” means a disposable delivery device designed for the automatic injection of a premeasured dose of epinephrine into the human body to prevent or treat a life-threatening allergic reaction.

(4) “Lay rescuer” means any person who has met the training standards and other requirements of this section but who is not otherwise licensed or certified to use an epinephrine auto-injector on another person.

(5) “Prehospital emergency medical care person” has the same meaning as defined in paragraph (2) of subdivision (a) of Section 1797.189.

(b) A prehospital emergency medical care person or lay rescuer may use an epinephrine auto-injector to render emergency care to another person if all of the following requirements are met:

(1) The epinephrine auto-injector is legally obtained by prescription from an authorized health care provider or from an authorized entity that acquired the epinephrine auto-injector pursuant to subdivision (e).

(2) The epinephrine auto-injector is used on another, with the expressed or implied consent of that person, to treat anaphylaxis.

(3) The epinephrine auto-injector is stored and maintained as directed by the manufacturer’s instructions for that product.

(4) The person using the epinephrine auto-injector has successfully completed a course of training with an authorized training provider, as

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Ch. 374 — 8 —

described in subdivision (c), and has current certification of training issued by the provider.

(5) The epinephrine auto-injectors obtained by prehospital emergency medical care personnel pursuant to Section 4119.3 of the Business and Professions Code shall be used only when functioning outside the course of the person’s occupational duties, or as a volunteer, pursuant to this section.

(6) The Emergency Medical Services System is activated as soon as practicable when an epinephrine auto-injector is used.

(c) (1) The authorized training providers shall be approved, and the minimum standards for training and the use and administration of epinephrine auto-injectors pursuant to this section shall be established and approved, by the authority. The authority may designate existing training standards for the use and administration of epinephrine auto-injectors by prehospital emergency medical care personnel to satisfy the requirements of this section.

(2) The minimum training and requirements shall include all of the following components:

(A) Techniques for recognizing circumstances, signs, and symptoms of anaphylaxis.

(B) Standards and procedures for proper storage and emergency use of epinephrine auto-injectors.

(C) Emergency followup procedures, including activation of the Emergency Medical Services System, by calling the emergency 9-1-1 telephone number or otherwise alerting and summoning more advanced medical personnel and services.

(D) Compliance with all regulations governing the training, indications, use, and precautions concerning epinephrine auto-injectors.

(E) Written material covering the information required under this provision, including the manufacturer product information sheets on commonly available models of epinephrine auto-injectors.

(F) Completion of a training course in cardiopulmonary resuscitation and the use of an automatic external defi (AED) for infants, children, and adults that complies with regulations adopted by the authority and the standards of the American Heart Association or the American Red Cross, and a current certification for that training.

(3) Training certification shall be valid for no more than two years, after which recertification with an authorized training provider is required.

(4) The director may, in accordance with regulations adopted by the authority, deny, suspend, or revoke any approval issued under this subdivision or may place any approved training provider on probation upon a finding by the director of an imminent threat to public health and safety, as evidenced by any of the following:

(A) Fraud. (B) Incompetence. (C) The commission of any fraudulent, dishonest, or corrupt act that is

substantially related to the qualifications, functions, or duties of training program directors or instructors.

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(D) Conviction of any crime that is substantially related to the qualifications, functions, or duties of training program directors or instructors. The record of conviction or a certified copy of the record shall be conclusive evidence of the conviction.

(E) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of this section or the regulations promulgated by the authority pertaining to the review and approval of training programs in anaphylaxis and the use and administration of epinephrine auto-injectors, as described in this subdivision.

(d) (1) The authority shall assess a fee pursuant to regulation sufficient to cover the reasonable costs incurred by the authority for the ongoing review and approval of training and certification under subdivision (c).

(2) The fees shall be deposited in the Specialized First Aid Training Program Approval Fund, which is hereby created in the State Treasury. All moneys deposited in the fund shall be made available, upon appropriation, to the authority for purposes described in paragraph (1).

(3) The authority may transfer unused portions of the Specialized First Aid Training Program Approval Fund to the Surplus Money Investment Fund. Funds transferred to the Surplus Money Investment Fund shall be placed in a separate trust account, and shall be available for transfer to the Specialized First Aid Training Program Approval Fund, together with the interest earned, when requested by the authority.

(4) The authority shall maintain a reserve balance in the Specialized First Aid Training Program Approval Fund of 5 percent of annual revenues. Any increase in the fees deposited in the Specialized First Aid Training Program Approval Fund shall be effective upon determination by the authority that additional moneys are required to fund expenditures pursuant to subdivision (c).

(e) (1) An authorized health care provider may issue a prescription for an epinephrine auto-injector to a prehospital emergency medical care person or a lay rescuer for the purpose of rendering emergency care to another person upon presentation of a current epinephrine auto-injector certifi card issued by the authority demonstrating that the person is trained and qualified to administer an epinephrine auto-injector pursuant to this section or any other law.

(2) An authorized health care provider may issue a prescription for an epinephrine auto-injector to an authorized entity if the authorized entity submits evidence it employs at least one person, or utilizes at least one volunteer or agent, who is trained and has a current epinephrine auto-injector certification card issued by the authority demonstrating that the person is qualifi to administer an epinephrine auto-injector pursuant to this section.

(f) An authorized entity that possesses and makes available epinephrine auto-injectors shall do both of the following:

(1) Create and maintain on its premises an operations plan that includes all of the following:

(A) The name and contact number for the authorized health care provider who prescribed the epinephrine auto-injector.

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(B) Where and how the epinephrine auto-injector will be stored. (C) The names of the designated employees or agents who have

completed the training program required by this section and who are authorized to administer the epinephrine auto-injector.

(D) How and when the epinephrine auto-injector will be inspected for an expiration date.

(E) The process to replace the expired epinephrine auto-injector, including the proper disposal of the expired epinephrine auto-injector or used epinephrine auto-injector in a sharps container.

(2) Submit to the authority, in a manner identified by the authority, a report of each incident that involves the use of an epinephrine auto-injector, not more than 30 days after each use. The authority shall annually publish a report that summarizes all reports submitted to it under this subdivision.

(g) This section shall not apply to a school district or county office of education, or its personnel, that provides and utilizes epinephrine auto-injectors to provide emergency medical aid pursuant to Section 49414 of the Education Code.

(h) This section shall not be construed to limit or restrict the ability of prehospital emergency medical care personnel, under any other statute or regulation, to administer epinephrine, including the use of epinephrine auto-injectors, or to require additional training or certification beyond what is already required under the other statute or regulation.

SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the defi of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.

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BOARD OF REGISTERED NURSING PO Box 944210, Sacramento, CA 94244-2100 P (916) 322-3350 F (916) 574-8637 | www.rn.ca.gov

BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY • GOVERNOR EDMUND G. BROWN JR.

Emergency medical care, epinephrine auto-injectors

“Authorized Entity”

Legislative session 2015-2016 An act to add Section 4119.4 to the Business and Professions Code, to amend Section 1714.23 of the Civil Code, to amend Section 49414 of Education Code, relating to emergency medical care. AB No.1386 (Low) Chapter 374 Emergency medical care: epinephrine auto- injector Authorized Entity (1) Existing law authorizes a prehospital emergency medical care person, first responder, or lay rescuer to use an epinephrine auto-injector to render emergency care to another person. Existing law requires the Emergency Medical Services Authority to approve authorized training providers and the minimum standards for training and the use and administration of epinephrine auto-injectors. The existing Pharmacy Law also authorizes a pharmacy to dispense epinephrine auto-injectors to a prehospital emergency medical care person, first responder, or lay rescuer for the purpose of rendering emergency care.. Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors, as defined, to school nurses and trained personnel who have volunteered to use epinephrine auto-injectors under emergency circumstances, and authorizes school nurses and trained personnel to use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. “Authorized entity” means any for profit, nonprofit, or governmental entity or organization that employs at least one person or utilizes at least one volunteer or agent that has voluntarily completed training course to administer epinephrine auto-injector. “Authorized entity,” trained individual may use an epinephrine auto-injector to render emergency care to another person in accordance with these provisions. The law would also authorize a pharmacy to furnish epinephrine auto-injectors to an authorized entity, The law would require an authorized entity to create and maintain a specified operations plan relating to its use of epinephrine auto-injectors, and would require those entities to submit a report to the Emergency Medical Services Authority of each incident that involves the administration of an epinephrine auto-injector, not more than 30 days after each use. The law would also require the authority to publish an annual report summarizing the reports submitted to the authority pursuant to the law provisions. This law would provide that an employee, agents, or other trained individuals of an authorized entity who administers an epinephrine auto-injector to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation, in good faith and not for compensation, is not liable for any civil damages resulting from his or her act or omission in administer the epinephrine auto-injector, if the person has complied with specified certification and training requirement standards. The law would also provide that an authorized entity located in this state shall not be liable, in this state, for any injuries or related damage that results from the provision or administration of an epinephrine auto-injector by its employees or agents outside of this state if the entity or its employee or agent would not have been liable for those injuries or related damages had the provision or administration occurred within this state.

The law requires an authorized entity to create and maintain as specified operational plan relating to its use of epinephrine auto-injectors, and would require those entities submit a report to the Emergency Medical Services Authority of each incident that involves the administration of an auto-injector, not more than 30 days after each use. The authorized entity would be require the authority to publish an annual report summarizing the reports submitted to the department authority . For complete information on all aspects of emergency medical care, epinephrine auto-injectors go to the specific amended sections, Business and Professions Code 4119.4; Civil Code 1714.23; and Education Code 49414.

BOARD OF REGISTERED NURSING Nursing Practice Committee

Agenda Item Summary

AGENDA ITEM: 10.3 DATE: March 8, 2017

ACTION REQUESTED: Information Only: Pupil Health: Naloxone Hydrochloride, and other Opioid Antagonist

REQUESTED BY: Trande Phillips RN

Chair Practice Committee

BACKGROUND: This bill would authorize a school district, county office of education, or charter school to provide emergency naloxone hydrochloride or another opioid antagonist to school nurses and trained personnel who have volunteered, as specified, and authorizes school nurses and trained personnel to use naloxone hydrochloride or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. The bill would expressly authorize each public and private elementary and secondary school in the state to voluntarily determine whether or not to make emergency naloxone hydrochloride or another opioid antagonist and trained personnel available at its school and to designate one or more school personnel to receive prescribed training regarding naloxone hydrochloride or another opioid antagonist from individuals in specified positions. NEXT STEPS: Place on Board agenda. FISCAL IMPACT, IF ANY: PERSON(S) TO CONTACT:

Janette Wackerly, MBA, BSN, RN Supervising Nursing Education Consultant Janette.Wackerly@dca.ca.gov (916) 574-7686

BOARD OF REGISTERED NURSING PO Box 944210, Sacramento, CA 94244-2100 P (916) 322-3350 F (916) 574-8637 | www.rn.ca.gov

BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY • GOVERNOR EDMUND G. BROWN JR.

Pupils; pupil health: opioid antagonist

Legislative Session 2015-2016 An act to add Section 4119.8 to the Business and Professions Code, and to add Section 49414.3 to the Education Code, relating to pupils. AB 1748, (Mayes) Chapter 557 Pupils: pupil health: opioid antagonist. Existing law authorizes a pharmacy to furnish epinephrine auto-injectors to a school district, county office of education, or charter school if certain conditions are met. Existing law requires the school district, county office of education, or charter school to maintain records regarding the acquisition and disposition of epinephrine auto-injectors furnished by the pharmacy for a period of 3 years from the date the records were created. The governing board of any school district is required to give diligent care to the health and physical development of pupils, and may employ properly certified persons for that work. Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors to school nurses or trained volunteer personnel and authorizes school nurses and trained personnel to use epinephrine auto-injectors to provide emergency medical aid to persons suffering or reasonably believed to be suffering, from an anaphylactic reaction, as provided. This law authorize’ s a pharmacy to furnish naloxone hydrochloride or another opioid antagonist to a school district, county office of education, or charter school if certain conditions are met. The law would require the school district, county office of education, or charter school to maintain records regarding the acquisition and disposition of naloxone hydrochloride or another opioid antagonist furnished by the pharmacy for a period of 3 years from the date the records were created. This law authorize’s a school district, county office of education, or charter school to provide emergency naloxone hydrochloride or another opioid antagonist to school nurses and trained personnel who have volunteered, and authorizes school nurses and trained personnel to use naloxone hydrochloride or another opioid antagonist to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an opioid overdose. The law expressly authorizes each public and private elementary and secondary school in the state to voluntarily determine whether or not to make emergency naloxone hydrochloride or another opioid antagonist and trained personnel available at its school and to designate one or more school personnel to receive prescribed training regarding naloxone hydrochloride or another opioid antagonist from individuals in specified positions.

The Superintendent of Public Instruction to establish minimum standards of training for the administration of naloxone hydrochloride or another opioid antagonist, to review these standards every 5 years or sooner, and to consult with organizations and providers with expertise in administering naloxone hydrochloride or another opioid antagonist and administering medication in a school environment in developing and reviewing those standards. The qualified supervisor of health or administrator at a school district, county office of education, or charter school electing to utilize naloxone hydrochloride or another opioid antagonist for emergency medical aid to obtain the prescription for naloxone hydrochloride or another opioid antagonist from an authorizing physician and surgeon, and would authorize the prescription to be filled by local or mail order pharmacies or naloxone hydrochloride or another opioid antagonist manufacturers. The school nurses or, if the school does not have a school nurse, a person who has received training regarding naloxone hydrochloride or another opioid antagonist, to immediately administer naloxone hydrochloride or another opioid antagonist under certain circumstances. The law would provide that no volunteers may administer naloxone hydrochloride or another opioid antagonist only nasal spray or auto-injector. The individuals initiate emergency medical services or other appropriate medical followup in accordance with written training materials. The law would prohibit an authorizing physician and surgeon from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for any act in the issuing of a prescription or order, pursuant to these provisions, unless the act constitutes gross negligence or willful or malicious conduct. The law would prohibit a person trained under these provisions, who acts with reasonable care in administering naloxone hydrochloride or another opioid antagonist, in good faith, to a person who is experiencing or is suspected of experiencing an opioid overdose from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for this administration. This bill would provide that an employee who volunteers pursuant to this section may rescind his or her offer to administer emergency naloxone hydrochloride or another opioid antagonist at any time, including after receipt of training. The volunteer shall be allowed to administer naloxone hydrochloride or another opioid antagonist in the available form the volunteer is most comfortable with. The State Department of Education to include on its Internet Web site a clearinghouse for best practices in training nonmedical personnel to administer naloxone hydrochloride or another opioid antagonist to pupils. The law would require a school district, county office of education, or charter school choosing to exercise the authority to provide emergency naloxone hydrochloride or another opioid antagonist to provide the training for the volunteers at no cost to the volunteers and during the volunteers’ regular working hours. The law would delete the requirement that those individuals who are authorized to administer naloxone hydrochloride or another opioid antagonist under certain circumstances initiate emergency medical services or other appropriate medical followup in accordance with written training materials. The law would provide that training include basic emergency followup procedures, including but not limited to, a school or charter school administrator or, if the administrator is not available, another school staff

member to call the emergency 911 telephone number and to contact the pupil’s parent or guardian. The law would provide that the requirement for the school or charter school administrator or other school staff member to call the emergency 911 telephone number shall not require a pupil to be transported to an emergency room. The law would prohibit a person trained under these provisions who administers naloxone hydrochloride or another opioid antagonist, in good faith and not for compensation, to a person who appears to be experiencing an opioid overdose from being subject to professional review, being liable in a civil action, or being subject to criminal prosecution for this administration.

Assembly Bill No. 1748

CHAPTER 557

An act to add Section 4119.8 to the Business and Professions Code, andto add Section 49414.3 to the Education Code, relating to pupils.

[Approved by Governor September 24, 2016. Filed withSecretary of State September 24, 2016.]

legislative counsel’s digest

AB 1748, Mayes. Pupils: pupil health: opioid antagonist.(1)  Existing law authorizes a pharmacy to furnish epinephrine

auto-injectors to a school district, county office of education, or charterschool if certain conditions are met. Existing law requires the school district,county office of education, or charter school to maintain records regardingthe acquisition and disposition of epinephrine auto-injectors furnished bythe pharmacy for a period of 3 years from the date the records were created.

This bill would authorize a pharmacy to furnish naloxone hydrochlorideor another opioid antagonist to a school district, county office of education,or charter school if certain conditions are met. The bill would require theschool district, county office of education, or charter school to maintainrecords regarding the acquisition and disposition of naloxone hydrochlorideor another opioid antagonist furnished by the pharmacy for a period of 3years from the date the records were created.

(2)  Under existing law, the governing board of a school district is requiredto give diligent care to the health and physical development of pupils andmay employ properly certified persons for that work. Existing law requiresschool districts, county offices of education, and charter schools to provideemergency epinephrine auto-injectors to school nurses or trained volunteerpersonnel and authorizes school nurses and trained personnel to useepinephrine auto-injectors to provide emergency medical aid to personssuffering, or reasonably believed to be suffering, from an anaphylacticreaction, as provided.

This bill would authorize a school district, county office of education, orcharter school to provide emergency naloxone hydrochloride or anotheropioid antagonist to school nurses and trained personnel who havevolunteered, as specified, and authorizes school nurses and trained personnelto use naloxone hydrochloride or another opioid antagonist to provideemergency medical aid to persons suffering, or reasonably believed to besuffering, from an opioid overdose. The bill would expressly authorize eachpublic and private elementary and secondary school in the state to voluntarilydetermine whether or not to make emergency naloxone hydrochloride oranother opioid antagonist and trained personnel available at its school andto designate one or more school personnel to receive prescribed training

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regarding naloxone hydrochloride or another opioid antagonist fromindividuals in specified positions.

The bill would require the Superintendent of Public Instruction to establishminimum standards of training for the administration of naloxonehydrochloride or another opioid antagonist, to review these standards every5 years or sooner as specified, and to consult with organizations andproviders with expertise in administering naloxone hydrochloride or anotheropioid antagonist and administering medication in a school environment indeveloping and reviewing those standards. The bill would require the StateDepartment of Education to include on its Internet Web site a clearinghousefor best practices in training nonmedical personnel to administer naloxonehydrochloride or another opioid antagonist to pupils.

The bill would require a school district, county office of education, orcharter school choosing to exercise the authority to provide emergencynaloxone hydrochloride or another opioid antagonist to provide the trainingfor the volunteers at no cost to the volunteers and during the volunteers’regular working hours. The bill would require a qualified supervisor ofhealth or administrator at a school district, county office of education, orcharter school electing to utilize naloxone hydrochloride or another opioidantagonist for emergency medical aid to obtain the prescription for naloxonehydrochloride or another opioid antagonist from an authorizing physicianand surgeon, as defined, and would authorize the prescription to be filledby local or mail order pharmacies or naloxone hydrochloride or anotheropioid antagonist manufacturers.

The bill would authorize school nurses or, if the school does not have aschool nurse, a person who has received training regarding naloxonehydrochloride or another opioid antagonist to immediately administernaloxone hydrochloride or another opioid antagonist under certaincircumstances. The bill would provide that volunteers may administernaloxone hydrochloride or another opioid antagonist only by nasal spray orby auto-injector, as specified.

The bill would prohibit an authorizing physician and surgeon from beingsubject to professional review, being liable in a civil action, or being subjectto criminal prosecution for any act in the issuing of a prescription or order,pursuant to these provisions, unless the act constitutes gross negligence orwillful or malicious conduct. The bill would prohibit a person trained underthese provisions who administers naloxone hydrochloride or another opioidantagonist, in good faith and not for compensation, to a person who appearsto be experiencing an opioid overdose from being subject to professionalreview, being liable in a civil action, or being subject to criminal prosecutionfor this administration.

The people of the State of California do enact as follows:

SECTION 1. Section 4119.8 is added to the Business and ProfessionsCode, to read:

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4119.8. (a)  Notwithstanding any other law, a pharmacy may furnishnaloxone hydrochloride or another opioid antagonist to a school district,county office of education, or charter school pursuant to Section 49414.3of the Education Code if all of the following are met:

(1)  The naloxone hydrochloride or another opioid antagonist is furnishedexclusively for use at a school district schoolsite, county office of educationschoolsite, or charter school.

(2)  A physician and surgeon provides a written order that specifies thequantity of naloxone hydrochloride or another opioid antagonist to befurnished.

(b)  Records regarding the acquisition and disposition of naloxonehydrochloride or another opioid antagonist furnished pursuant to subdivision(a) shall be maintained by the school district, county office of education, orcharter school for a period of three years from the date the records werecreated. The school district, county office of education, or charter schoolshall be responsible for monitoring the supply of naloxone hydrochlorideor another opioid antagonist and ensuring the destruction of expired naloxonehydrochloride or another opioid antagonist.

SEC. 2. Section 49414.3 is added to the Education Code, to read:49414.3. (a)  School districts, county offices of education, and charter

schools may provide emergency naloxone hydrochloride or another opioidantagonist to school nurses or trained personnel who have volunteeredpursuant to subdivision (d), and school nurses or trained personnel may usenaloxone hydrochloride or another opioid antagonist to provide emergencymedical aid to persons suffering, or reasonably believed to be suffering,from an opioid overdose.

(b)  For purposes of this section, the following terms have the followingmeanings:

(1)  “Authorizing physician and surgeon” may include, but is not limitedto, a physician and surgeon employed by, or contracting with, a localeducational agency, a medical director of the local health department, or alocal emergency medical services director.

(2)  “Auto-injector” means a disposable delivery device designed for theautomatic injection of a premeasured dose of an opioid antagonist into thehuman body and approved by the federal Food and Drug Administrationfor layperson use.

(3)  “Opioid antagonist” means naloxone hydrochloride or another drugapproved by the federal Food and Drug Administration that, whenadministered, negates or neutralizes in whole or in part the pharmacologicaleffects of an opioid in the body, and has been approved for the treatmentof an opioid overdose.

(4)  “Qualified supervisor of health” may include, but is not limited to, aschool nurse.

(5)  “Volunteer” or “trained personnel” means an employee who hasvolunteered to administer naloxone hydrochloride or another opioidantagonist to a person if the person is suffering, or reasonably believed to

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be suffering, from an opioid overdose, has been designated by a school, andhas received training pursuant to subdivision (d).

(c)  Each public and private elementary and secondary school in the statemay voluntarily determine whether or not to make emergency naloxonehydrochloride or another opioid antagonist and trained personnel availableat its school. In making this determination, a school shall evaluate theemergency medical response time to the school and determine whetherinitiating emergency medical services is an acceptable alternative to naloxonehydrochloride or another opioid antagonist and trained personnel. A privateelementary or secondary school choosing to exercise the authority providedunder this subdivision shall not receive state funds specifically for purposesof this subdivision.

(d)  (1)  Each public and private elementary and secondary school in thestate may designate one or more volunteers to receive initial and annualrefresher training, based on the standards developed pursuant to subdivision(e), regarding the storage and emergency use of naloxone hydrochloride oranother opioid antagonist from the school nurse or other qualified persondesignated by an authorizing physician and surgeon. A benefit shall not begranted to or withheld from any individual based on his or her offer tovolunteer, and there shall be no retaliation against any individual forrescinding his or her offer to volunteer, including after receiving training.Any school district, county office of education, or charter school choosingto exercise the authority provided under this subdivision shall provide thetraining for the volunteers at no cost to the volunteer and during thevolunteer’s regular working hours.

(2)  An employee who volunteers pursuant to this section may rescindhis or her offer to administer emergency naloxone hydrochloride or anotheropioid antagonist at any time, including after receipt of training.

(e)  (1)  The Superintendent shall establish minimum standards of trainingfor the administration of naloxone hydrochloride or another opioid antagonistthat satisfies the requirements of paragraph (2). Every five years, or sooneras deemed necessary by the Superintendent, the Superintendent shall reviewminimum standards of training for the administration of naloxonehydrochloride or other opioid antagonists that satisfy the requirements ofparagraph (2). For purposes of this subdivision, the Superintendent shallconsult with organizations and providers with expertise in administeringnaloxone hydrochloride or another opioid antagonist and administeringmedication in a school environment, including, but not limited to, theCalifornia Society of Addiction Medicine, the Emergency Medical ServicesAuthority, the California School Nurses Organization, the California MedicalAssociation, the American Academy of Pediatrics, and others.

(2)  Training established pursuant to this subdivision shall include all ofthe following:

(A)  Techniques for recognizing symptoms of an opioid overdose.(B)  Standards and procedures for the storage, restocking, and emergency

use of naloxone hydrochloride or another opioid antagonist.

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(C)  Basic emergency followup procedures, including, but not limited to,a requirement for the school or charter school administrator or, if theadministrator is not available, another school staff member to call theemergency 911 telephone number and to contact the pupil’s parent orguardian.

(D)  Recommendations on the necessity of instruction and certificationin cardiopulmonary resuscitation.

(E)  Written materials covering the information required under thissubdivision.

(3)  Training established pursuant to this subdivision shall be consistentwith the most recent guidelines for medication administration issued by thedepartment.

(4)  A school shall retain for reference the written materials preparedunder subparagraph (E) of paragraph (2).

(5)  The department shall include on its Internet Web site a clearinghousefor best practices in training nonmedical personnel to administer naloxonehydrochloride or another opioid antagonist to pupils.

(f)  Any school district, county office of education, or charter schoolelecting to utilize naloxone hydrochloride or another opioid antagonist foremergency aid shall distribute a notice at least once per school year to allstaff that contains the following information:

(1)  A description of the volunteer request stating that the request is forvolunteers to be trained to administer naloxone hydrochloride or anotheropioid antagonist to a person if the person is suffering, or reasonably believedto be suffering, from an opioid overdose.

(2)  A description of the training that the volunteer will receive pursuantto subdivision (d).

(3)  The right of an employee to rescind his or her offer to volunteerpursuant to this section.

(4)  A statement that no benefit will be granted to or withheld from anyindividual based on his or her offer to volunteer and that there will be noretaliation against any individual for rescinding his or her offer to volunteer,including after receiving training.

(g)  (1)  A qualified supervisor of health at a school district, county officeof education, or charter school electing to utilize naloxone hydrochlorideor another opioid antagonist for emergency aid shall obtain from anauthorizing physician and surgeon a prescription for each school for naloxonehydrochloride or another opioid antagonist. A qualified supervisor of healthat a school district, county office of education, or charter school shall beresponsible for stocking the naloxone hydrochloride or another opioidantagonist and restocking it if it is used.

(2)  If a school district, county office of education, or charter school doesnot have a qualified supervisor of health, an administrator at the schooldistrict, county office of education, or charter school shall carry out theduties specified in paragraph (1).

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(3)  A prescription pursuant to this subdivision may be filled by local ormail order pharmacies or naloxone hydrochloride or another opioidantagonist manufacturers.

(4)  An authorizing physician and surgeon shall not be subject toprofessional review, be liable in a civil action, or be subject to criminalprosecution for the issuance of a prescription or order pursuant to this section,unless the physician and surgeon’s issuance of the prescription or orderconstitutes gross negligence or willful or malicious conduct.

(h)  (1)  A school nurse or, if the school does not have a school nurse orthe school nurse is not onsite or available, a volunteer may administernaloxone hydrochloride or another opioid antagonist to a person exhibitingpotentially life-threatening symptoms of an opioid overdose at school or aschool activity when a physician is not immediately available. If the naloxonehydrochloride or another opioid antagonist is used it shall be restocked assoon as reasonably possible, but no later than two weeks after it is used.Naloxone hydrochloride or another opioid antagonist shall be restockedbefore its expiration date.

(2)  Volunteers may administer naloxone hydrochloride or another opioidantagonist only by nasal spray or by auto-injector.

(3)  A volunteer shall be allowed to administer naloxone hydrochlorideor another opioid antagonist in a form listed in paragraph (2) that thevolunteer is most comfortable with.

(i)  A school district, county office of education, or charter school electingto utilize naloxone hydrochloride or another opioid antagonist for emergencyaid shall ensure that each employee who volunteers under this section willbe provided defense and indemnification by the school district, county officeof education, or charter school for any and all civil liability, in accordancewith, but not limited to, that provided in Division 3.6 (commencing withSection 810) of Title 1 of the Government Code. This information shall bereduced to writing, provided to the volunteer, and retained in the volunteer’spersonnel file.

(j)  (1)  Notwithstanding any other law, a person trained as required undersubdivision (d), who administers naloxone hydrochloride or another opioidantagonist, in good faith and not for compensation, to a person who appearsto be experiencing an opioid overdose shall not be subject to professionalreview, be liable in a civil action, or be subject to criminal prosecution forhis or her acts or omissions in administering the naloxone hydrochloride oranother opioid antagonist.

(2)  The protection specified in paragraph (1) shall not apply in a case ofgross negligence or willful and wanton misconduct of the person who rendersemergency care treatment by the use of naloxone hydrochloride or anotheropioid antagonist.

(3)  Any public employee who volunteers to administer naloxonehydrochloride or another opioid antagonist pursuant to subdivision (d) isnot providing emergency medical care “for compensation,” notwithstandingthe fact that he or she is a paid public employee.

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(k)  A state agency, the department, or a public school may accept gifts,grants, and donations from any source for the support of the public schoolcarrying out the provisions of this section, including, but not limited to, theacceptance of naloxone hydrochloride or another opioid antagonist from amanufacturer or wholesaler.

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BOARD OF REGISTERED NURSING Nursing Practice Committee

Agenda Item Summary

AGENDA ITEM: 10.2 DATE: March 8, 2017

ACTION REQUESTED: Discussion and Possible Recommendation to Create Advanced Practice Committee

REQUESTED BY: Trande Phillips, RN, Chair

Nursing Practice Committee BACKGROUND: The purpose of the advanced practice committee is to provide recommendations to the Board on issues involving nursing advanced practice. The advanced practice registered nurses are nurse practitioner, nurse anesthetist, nurse-midwives and clinical nurse specialists. The goals of the advanced practice committee:

1. Clarify and articulate sufficiency of the four advanced practice roles and recommend changes to the Nursing Practice Act and rules

2. Develop recommendations for joint statements related to scope of practice and advanced practice nurse functions

3. Review national trends in the regulation of advance practice nurses and make recommendations to the board.

4. Collaborate with other Board committees on matters of mutual interest Suggestion for committee members to include 2 board members, 1 BRN staff, 1 NEC, 4 NPs, 2 CRNA, 2 CNS, and 2 CNM. The committee members are requested to have diverse and rich backgrounds. Members include nurses from various areas of nursing agencies and health care setting throughout the state. Each member may serve a maximum of two consecutive terms. Suggestion for committee meetings to be held semi-annually in Sacramento in person and by WebEx The Senate Committee on Business, Professions and Economic Development and the Assembly Business and Professions Committee recommends the BRN should establish an Advanced Practice Committee, separate from the Nursing Practice Committee, whose goal is to survey existing laws and regulations and determine what is lacking for regulation of APRNs. The BRN should seek legislation, promulgate regulations, and develop advisories to ensure APRNs have sufficient guidance in all practice settings.

NEXT STEPS: Place on Board agenda. FISCAL IMPACT, IF ANY: Possible travel costs PERSON(S) TO CONTACT: Janette Wackerly, MBA, BSN, RN

Supervising Nursing Education Consultant Janette.Wackerly@dca.ca.gov (916) 574-7686