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Oregon Bulletin

February 1, 2011

Oregon Health Licensing Agency,
Board of Direct Entry Midwifery
Chapter 332

Rule Caption: Standardization of rules, amend definitions, qualification standards, application, education, examination and license posting requirements.

Adm. Order No.: DEM 4-2010

Filed with Sec. of State: 12-30-2010

Certified to be Effective: 1-1-11

Notice Publication Date: 10-1-2010

Rules Adopted: 332-015-0080

Rules Amended: 332-015-0000, 332-015-0030, 332-015-0040, 332-015-0050, 332-015-0070

Rules Repealed: 332-015-0010, 332-015-0060, 332-015-0065

Subject: General amendments to OAR 332 division 15 to align with current industry, agency and statewide rulemaking standards and principles.

Streamline definitions to meet rulemaking protocols and define relevant terms where utilized within the rule for efficiency including defining agency, baby, consultation when used in a non-absolute risk setting, and LDM as a licensed direct entry midwife.

Clarify and streamline application requirements for the following pathways:

Certified Professional Midwives (CPM) Credential and proof of 10 of the 50 births being within two years preceding the date of application.

Passage of North American Registry of Midwives (NARM) examination within three years preceding the date of application and proof of 10 of the 50 births being within two years preceding the date of application.

Delineate requirements for multiple birth attendants present at the same birth, one must be designated as the primary birth attendant.

Reference by rule general education requirements listed in the NARM CPM candidate information bulletin and the and the NARM examination as the qualifying examination for licensure.

Amend legend drugs and devices initial program with includes realignment of the 40 hours of training to reflect appropriate and actual training needs. Division of treatment of shock and intravenous therapy to allow specific hours in each area of training.

Adopt rule delineating licensure posting requirements for LDMs.

Repeal specific rules to streamline application process and remove redundancies.

Rules Coordinator: Samantha Patnode—(503) 373-1917

332-015-0000

Definitions

The following definitions apply as used in OAR 332-015-0000 through 332-030- 0000.

(1) “Agency” means the Oregon Health Licensing Agency. The agency is responsible for the budget, personnel, performance-based outcomes, consumer protection, fee collection, mediation, complaint resolution, discipline, rulemaking and record keeping.

(2) “Antepartum” means the period of time before the onset of labor.

(3) “Board” means, pursuant to ORS 687.470, the entity that advises the agency on matters relating to the practice of direct entry midwifery, and determines practice standards, education and training, and provides consultation to the agency on all disciplinary issues in accordance with ORS 687.405 to 687.495.

(4) “Baby” means the fetus and the newborn.

(5) “Consultation” means a dialogue for the purpose of obtaining information or advice from a health care provider by phone, written notes, or in person, which may include, but is not limited to identification of and recommendation regarding management of maternal or fetal conditions.

(6) “Fetal distress” is a condition in which the fetus demonstrates progressive and irresolvable clinical signs of compromise, which may include, but are not limited to, abnormal fetal movement; loss of heart tone variability; non-reassuring fetal heart rate deceleration patterns such as late decelerations; and non-reassuring changes in fetal heart baseline rate.

(7) “Informed Consent” means the consent obtained following a thorough and easily understood explanation of the information to the mother or the mother’s guardian. Refer to OAR 332-025-0080.

(8) “Intrapartum” means the period of time from the onset of labor through the birth of the placenta.

(9) “LDM” means licensed direct entry midwife.

(10) “MANA” means the Midwives Alliance of North America.

(11) “MEAC” means the Midwifery Education and Accreditation Council.

(12) “NARM” means the North American Registry of Midwives.

(13) “Peer review” means the discussion of cases with other health care providers and students for the purpose of obtaining and providing suggestions regarding care.

(14) “Postpartum” means the period of time immediately after and up to eight weeks following the birth of the baby.

(15) “Prenatal” means the period of time from conception to the onset of labor.

(16) “Primary birth attendant” means the midwife who assumes direct responsibility for mother and baby care.

(17) “Sharps” means items that includes needles, intravenous tubing with needles attached, scalpel blades, lancets, glass tubes that could be broken during handling and syringes that have been removed from their original sterile containers.

Stat. Auth.: ORS 687.485

Stats. Implemented: ORS 183.450(7) & 687.485

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-1998, f. 2-27-98, cert. ef. 3-1-98; DEM 1-1999(Temp), f. 9-1-99, cert. ef. 9-9-99 thru 2-29-00; DEM 2-1999, f. 12-17-99, cert. ef. 12-20-99; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

332-015-0030

Application Requirements

An individual applying for licensure to practice direct entry midwifery must:

(1) Meet the requirements of OAR 331 division 30.

(2) Submit a completed application form prescribed by the agency, which must contain the information listed in OAR 331-030-0000 and be accompanied by payment of the required application and license fees.

(3) Submit current certification in cardiopulmonary resuscitation for adults, neonates and infants.

(4) Submit documentation of required education in approved legend drugs and devices as provided in OAR 332-015-0070 on a form prescribed by the agency.

(5) Submit a written plan for emergency transport for mother or newborn pursuant to OAR 332-025-0020.

(6) In addition to requirements listed in subsection (1) through (5) of this rule, an applicant must provide documentation of one of the following pathways:

(a) Pathway 1 — Certified Professional Midwives (CPM) Credential:

(A) Submission of satisfactory evidence of having current CPM credential from NARM; and

(B) Pursuant to ORS 687.420, participation as an assistant at 25 deliveries, 25 deliveries for which the applicant was the primary birth attendant, participation in 100 prenatal care visits, 25 newborn examinations, and 40 postnatal examinations. The applicant must have provided continuity care for at least 10 of the primary birth attendant deliveries, including four prenatal visits, one newborn examination and one postpartum exam. Of these 50 births, at least 25 deliveries must have taken place in an out-of-hospital setting and 10 births must have occurred within the two years or 24 months preceding the date of application.

(C) If there is more than one birth attendant present at the same birth, the birth attendants must designate which birth attendant is primary.

(b) Pathway 2 — Passage of NARM Examination:

(A) Submission of satisfactory evidence of passage of the NARM examination within three years preceding the date of application, which must include official documentation of a passing score; and

(B) Pursuant to ORS 687.420, participation as an assistant at 25 deliveries, 25 deliveries for which the applicant was the primary birth attendant, participation in 100 prenatal care visits, 25 newborn examinations, and 40 postnatal examinations. The applicant must have provided continuity care for at least 10 of the primary birth attendant deliveries, including four prenatal visits, one newborn examination and one postpartum exam. Of these 50 births, at least 25 deliveries must have taken place in an out-of-hospital setting and 10 births must have occurred in the two years or 24 months preceding the date of application.

(C) If there is more than one birth attendant present at the same birth, the birth attendants must designate which birth attendant is primary.

Stat. Auth.: ORS 687.420 & 687.485

Stats. Implemented: ORS 687.420 & 687.485

Hist.: DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-1998, f. 2-27-98, cert. ef. 3-1-98; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

332-015-0040

Education

Applicant’s education must incorporate the general educational requirements listed in the NARM CPM candidate information bulletin, including:

(1) Core competencies developed by MANA;

(2) NARM written test specifications;

(3) NARM skills assessment test specifications;

(4) NARM written examination primary reference list; and

(5) NARM skills assessment reference list.

Stat. Auth.: ORS 183, 687.420, 687.480 & 687.485

Stats. Implemented: ORS 183, 687.420, 687.480 & 687.485

Hist.: DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-1998, f. 2-27-98, cert. ef. 3-1-98; DEM 2-1998, f. 4-14-98, cert. ef. 4-15-98; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

332-015-0050

NARM Midwifery Examination

The qualifying examination is the NARM examination. An applicant is responsible for payment of all fees for NARM applications, examinations, and any other fees paid directly to NARM.

Stat. Auth.: ORS 676.615, 687.480 & 687.485

Stats. Implemented: ORS 676.615, 687.480 & 687.485

Hist.: DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-1998, f. 2-27-98, cert. ef. 3-1-98; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

332-015-0070

Approved Legend Drugs and Devices Prescribed Education

(1) To be granted a license, an applicant must successfully complete the Initial Legend Drugs and Devices Program consisting of 40 clock hours of instruction in the approved curriculum. Each component of the initial program must be completed within the two years or 24 months immediately preceding the date of application. The initial program must be taught by a MEAC accredited or pre-accredited school, the Oregon Midwifery Council, or by an organization authorized by the Board. The program is composed of theory, hands-on practice, and skills testing for competency.

(2) The initial program consists of:

(a) Eight clock hours in Pharmacology covering drugs listed in OAR 332-025-0040 and 332-025-0050;

(A) Mechanism of Pharmacological Action;

(B) Indications;

(D) Side Effects/Adverse Reactions;

(E) Contraindications;

(F) Incompatibilities/Drug Interactions; and

(G) Drug administration including:

(i) Dosage;

(ii) Dosage Form and Packaging;

(iii) Routes of Administration;

(iv) Onset of Action;

(v) Peak Effect; and

(vi) Duration of Action.

(b) Four clock hours of administration of medications through injection, which includes:

(A) Universal precautions including the use and disposal of sharps;

(B) Equipment including:

(i) Needles;

(ii) Filter Needles (for use with glass ampules);

(iii) Syringes;

(iv) Skin surface disinfectants; and

(v) Medication containers (ampules, multi- and single-use vials).

(D) Procedures for drawing up and administering drugs;

(E) Special case: Administration of Medications Intravenously; and

(F) Care of equipment.

(A) Theory of shock; and

(B) Treatment of shock.

(d) Ten clock hours in intravenous therapy, which includes:

(A) Intravenous fluid therapy;

(B) Purpose of IV fluid therapy;

(D) Appropriate sites;

(E) Procedure;

(F) Rate of administration; and

(G) Care of equipment.

(e) Four clock hours in neonatal resuscitation, which includes:

(A) Basic life support techniques;

(B) Cardio-Pulmonary Resuscitation (CPR);

(D) Positive pressure ventilation (bag, valve, mask).

(f) 10 clock hours in suturing which includes:

(A) Explanation of the pelvic floor and genital anatomy;

(B) Assessing the degree of damage for repair;

(D) Equipment including:

(i) Sutures;

(ii) Needles; and

(iii) Instruments.

(E) Use of needle holder and working with curved needle;

(F) Knot tying (instrument knot);

(G) Basic stitching techniques including:

(i) Interrupted;

(ii) Basting;

(iii) Lock Blanket; and

(iv) Running mattress.

(H) Repairing a simple first-degree tear;

(I) Repairing a second-degree tear; and

(J) Repairing a third-degree tear.

(3) A copy of Board-approved curriculum objectives will be retained on file at the agency and made available upon receipt of a written request and payment of an administrative fee for acquiring public records. Refer to OAR 331-010-0030.

Stat. Auth.: ORS 676.615, ORS 687.485 & 687.493

Stats. Implemented: ORS 676.615, ORS 687.485 & 687.493

Hist.: DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 2-2008(Temp), f. 9-15-08 cert ef. 10-1-08 thru 3-30-09; DEM 1-2009, f. 3-31-09, cert. ef. 4-1-09; DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

332-015-0080

License Display and Posting Requirements

(1) A licensee must show proof of valid license with the agency upon request or post the license document in public view at the licensees primary workplace.

(2) A licensee may temporarily conceal the address printed on the license document with a covering that is removable.

(3) A licensee must carry the license identification card (pocket card), or post in plain view, the official license anytime services are being provided.

Stat. Auth.: ORS 687.485 & 687.615

Stats. Implemented: ORS 687.425, 687.485, 676.606 & 676.607

Hist.: DEM 4-2010, f. 12-30-10, cert. ef. 1-1-11

Rule Caption: Standardization of rules, amend requirements for renewal, late renewal, continuing education, data collection and fees.

Adm. Order No.: DEM 5-2010

Filed with Sec. of State: 12-30-2010

Certified to be Effective: 1-1-11

Notice Publication Date: 10-1-2010

Rules Adopted: 332-020-0017

Rules Amended: 332-020-0000, 332-020-0010, 332-020-0015, 332-020-0020

Rules Repealed: 332-020-0020(T)

Subject: General amendments to OAR 332 division 20 to align with current industry, agency and statewide rulemaking standards and principles.

Align renewals with agency standards and protocols, including renewal, inactive renewal up to three years, and expired renewal requiring reapplication under one of two pathways. Added requirements for renewal and late renewal including proof of current neonatal resuscitation and MANAstats reporting.

Reduce timeframe required to obtain continuing education in legend drugs and devices for renewal to two years to align with other continuing education requirements. Reduce number of continuing education hours required for legend drugs and devices from 12.5 to eight and a half hours and specify how many hours in each subject. Amend procedure for the continuing education audit process.

Adopt rule to align with statutory provisions pursuant to ORS 687.495 regarding data collection. Requires that all licensees report to a national database (MANAstats) through the Midwifery Alliance of North American (MANA) beginning June 2011 and send an individual report to the agency upon renewal beginning in June 2012.

Align fees with statutory provisions pursuant to ORS 687.435, by establishing a reactivation fee and ORS 676.615 by establishing a dormant renewal fee. Amend number of years a licensee can renew late up to three years to align with renewal requirements and agency protocol. Adopt temporary rule permanently regarding $500 original issuance license fee discount.

Rules Coordinator: Samantha Patnode—(503) 373-1917

332-020-0000

License Issuance and Renewal

(1) LICENSING: A licensee is subject to the provisions of OAR Chapter 331, division 30 regarding the issuance and renewal of a license, and provisions regarding authorization to practice, identification, and requirements for issuance of a duplicate license.

(2) LICENSE RENEWAL: License renewal must be made prior to the license entering inactive status. The licensee must submit the following:

(a) Renewal application form;

(b) Payment of required renewal fee;

(c) Attestation of having obtained required continuing education including legend drugs and devices pursuant to OAR 332-020-0010;

(d) Evidence of current certification in cardiopulmonary resuscitation for adults and infants;

(e) Evidence of current certification in neonatal resuscitation;

(f) Evidence of having completed peer review documented on a form prescribed by the agency pursuant to 332-025-0020; and

(g) Submit a copy of individual MANAstats practice report pursuant to OAR 332-020-0017.

(3) INACTIVE LICENSE RENEWAL: License renewal made after the license enters inactive status. A license may be inactive for up to three years. The licensee must submit the following:

(a) Renewal application form;

(b) Payment of delinquency and license fees pursuant to OAR 332-020-0020;

(c) Attestation of having obtained required continuing education including legend drugs and devices pursuant to OAR 332-020-0010;

(d) Evidence of current certification in cardiopulmonary resuscitation for adults and infants;

(e) Evidence of current certification in neonatal resuscitation; and

(f) Evidence of having completed peer review on a form prescribed by the agency pursuant to 332-025-0020.

(g) Submit a copy of individual MANAstats practice report pursuant to OAR 332-020-0017.

(4) EXPIRED LICENSE: A license that has been inactive for more than three years is expired and must meet the requirements listed in OAR 332-015-0030.

(5) A licensee failing to meet continuing education requirements listed under OAR 332-020-0010 must reapply and meet requirements pursuant to OAR 332-015-0030.

Stat. Auth.: ORS 676.605, 676.615, 687.420, 687.425, 687.430, 687.485 & 687.493

Stats. Implemented: ORS 676.605, 676.615, 687.420, 687.425, 687.430, 687.485 & 687.493

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 1-2008, f. 9-15-08 cert. ef. 10-1-08; DEM 5-2010, f. 12-30-10, cert. ef. 1-1-11

332-020-0010

Continuing Education

(1)(a) HOURLY REQUIREMENTS: To qualify for license renewal an LDM must complete approved continuing education requirements as follows:

(b) Two years from the date of initial licensure and every two years thereafter:

(A) Thirty clock hours relevant to women’s health, neonatal, fetal or midwifery knowledge or care, ethics, communication, or professional development.

(B) Eight and a half clock hours pertaining to legend drugs and devices that include the components listed under OAR 332-015-0070 with the exception of neonatal resuscitation under OAR 332-015-0070(e), which is required annually upon renewal. The eight and a half hours pertaining to legend drugs and devices must be taught by a MEAC accredited or pre-accredited school, the Oregon Midwifery Council or by an organization authorized by the board.

(i) One hour in pharmacology;

(ii) One half hour in administration of medications through injection;

(iii) One hour in advanced treatment of shock;

(iv) Three hours in intravenous therapy; and

(v) Three hours in suturing.

(2) CONTINUING EDUCATION PROVIDERS/SPONSORS: Continuing education includes attendance or participation at an instructional program presented, recognized, or under the auspices of any board approved institution or professional organization or association:.

(3) CONTINUING EDUCATION PATHWAYS:

(a) Attendance at lectures, post-secondary school or postgraduate courses, scientific sessions at conventions, courses offered by an agency or board approved association or licensed/accredited school, classes or courses offered through an institution such as the American Red Cross, hospitals, health care clinics, correspondence courses or internet courses.

(b) Continuing education relating to subject matter listed in subsection (1)(a)(A) of this rule may also be obtained through research or teaching (provided that no more than half the required hours be in teaching).

(c) Up to nine clock hours of continuing education relating to subject matter listed in subsection (1)(a)(A) of this rule may be completed through self-study and documented on forms provided by the agency.

(4) DOCUMENTATION REQUIREMENTS: Submission to the agency of proof of participation in continuing education is the responsibility of the LDM. The following provisions specify requirements for documenting completion of continuing education:

(a) Documentation must include the name of the sponsoring institution, association or organization, title of presentation, description of content, name of instructor or presenter, date, duration in hours, and license or statement of attendance or completion provided by the sponsor.

(b) Documentation verifying completion of all required continuing education must be accumulated and held by the LDM for two years following any reporting period, or until notification of audit is received. Continuing education documentation must be available and provided to the agency upon request. Refer to OAR 332-020-00105.

(5) ADDITIONAL REQUIREMENTS AND PROVISIONS: In addition to other requirements specified in this rule section, the following provisions apply toward meeting continuing education requirements as a condition of license renewal:

(a) In accordance with ORS 687.425 a licensee who has attended fewer than ten births in the previous two years is required to take an additional ten hours of continuing education in subjects listed in subsection (1)(a)(A) of this rule.

(b) Hours of continuing education that are obtained in excess of the minimum requirements listed in this rule will not be carried forward as credit for the subsequent license renewal reporting cycle.

(c) Continuing education is required for renewal even if the LDM license has been inactive, revoked or suspended during that period.

Stat. Auth.: ORS 676.615, 687.425 & 687.485

Stats. Implemented: ORS 676.615, 687.425 & 687.485

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 2-2008(Temp), f. 9-15-08 cert. ef. 10-1-08 thru 3-30-09; DEM 1-2009, f. 3-31-09, cert. ef. 4-1-09; DEM 5-2010, f. 12-30-10, cert. ef. 1-1-11

332-020-0015

Continuing Education: Audit, Required Documentation and Sanctions

(1) The agency will audit a select percentage of licenses determined by the board to verify compliance with continuing education requirements.

(2) A licensee notified of selection for audit of continuing education attestation must submit to the agency, within 30 calendar days from the date of notification, satisfactory evidence of participation in required continuing education in accordance with OAR 332-020-0010.

(3) If selected for audit, the licensee must provide documentation of the required continuing education, which must include:

(a) Certificate of completion, official transcript, statement or affidavit from the sponsor attesting to attendance or other documentation approved by the agency.

(b) Name of sponsoring institution/association or organization;

(d) Name of instructor or presenter;

(e) Date of attendance and duration in hours; and

(f) Course agenda.

(4) If documentation of continuing education is incomplete, the licensee has 30 calendar days from the date of notice to submit further documentation to substantiate having completed the required continuing education.

(5) Failure to meet continuing education requirements shall constitute grounds for disciplinary action, which may include but is not limited to assessment of a civil penalty and suspension or revocation of the license.

Stat. Auth.: ORS 687.425 & 687.485

Stats. Implemented: ORS 687.425 & 687.485

Hist.: DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 5-2010, f. 12-30-10, cert. ef. 1-1-11

332-020-0017

Reporting Requirements

(1) In accordance with ORS 687.495 an individual licensed as an LDM must submit data on every mother and baby electronically to the MANAstats Project on any form prescribed by MANA, and in accordance with the policies and procedures established by MANA. A licensee must:

(a) Begin data collection with MANA for each mother who initiates care as of June 1, 2011; and

(b) Submit a copy of their individual MANAstats practice report annually to the agency at the time of license renewal, beginning June 2012.

(2) A licensee is required to notify the agency of the number of mothers who decline consent to participate in the MANAstats data collection system annually on a form prescribed by the agency.

(3) When a mother declines consent to participate in the MANAstats data collection, the licensee must provide de-identified mother and baby data to the agency on a form prescribed by the agency. If there are multiple licensees present at the same birth, the licensees must determine which licensee will report to the agency.

Stat. Auth.: ORS 687.485 & 676.615

Stats. Implemented: ORS 687.425, 687.435, 687.485, 687.495, 676.606 & 676.607

Hist.: DEM 5-2010, f. 12-30-10, cert. ef. 1-1-11

332-020-0020

Fees

(1) An applicant and licensee are subject to the provisions of OAR 331-010-0010 and 331-010-0020 regarding payment of fees, penalties and charges.

(2) Fees established by the Oregon Health Licensing Agency are as follows:

(a) Application:

(A) License: $150.

(B) License by reciprocity: $750.

(b) Examination — Oregon laws & rules: $50.

(d) Renewal — License: $630 for one year;

(e) Reactivation of license: $150.

(f) Other administrative fees:

(A) Delinquency fee: $50 for each year in expired status up to three years.

(B) Replacement of license, including name change: $25.

(D) Affidavit of licensure for reciprocity: $50.

(E) An additional $25 administrative processing fee will be assessed if a non-sufficient funds or non-negotiable instrument is received for payment of fees, penalties and charges. Refer to OAR 331-010-0010.

(3) Applicants for original issuance of direct entry midwifery licensure may be granted a $500 original issuance of license fee discount, upon application for licensure. This license fee discount is available to fully qualified direct entry midwife applicants residing in Oregon, as long as funding remains available, and only to those fully qualified applicants who have not previously held direct entry midwife licensure in Oregon. To be eligible for this discount, applicants must meet all qualifications in accordance with OAR 332-015-0000, 332-015-0010 and 332-015-0030.

Stat. Auth.: ORS 676.605, 676.615, 687.435 & 687.485

Stats. Implemented: ORS 676.605, 676.615, 687.435 & 687.485

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-1997(Temp), f. 7-22-97, cert. ef. 7-23-97; DEM 1-1999(Temp), f. 9-1-99, cert. ef. 9-9-99 thru 2-29-00; DEM 2-1999, f. 12-17-99, cert. ef. 12-20-99; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 1-2008, f. 9-15-08 cert. ef. 10-1-08; DEM 1-2010(Temp), f. 3-31-10, cert. ef. 4-1-10 thru 9-13-10; DEM 2-2010, f. & cert. ef. 9-9-10; DEM 3-2010(Temp), f. 9-29-10, cert. ef. 10-1-10 thru 3-30-11; DEM 5-2010, f. 12-30-10, cert. ef. 1-1-11

Rule Caption: Clarify guidelines for risk criteria and practice/care standards. Create standard for information/ethics/terminating care.

Adm. Order No.: DEM 6-2010

Filed with Sec. of State: 12-30-2010

Certified to be Effective: 1-1-11

Notice Publication Date: 10-1-2010

Rules Adopted: 332-025-0070, 332-025-0080, 332-025-0100

Rules Amended: 332-025-0020, 332-025-0021, 332-025-0022, 332-025-0030, 332-025-0040, 332-025-0050, 332-025-0060, 332-030-0000

Subject: General amendments to OAR, chapter 332 division 25 and 30 to align with current industry, agency and statewide rulemaking standards and principles.

Align with current industry general practice standards to allow for flexibility and efficiency as well as support statutory requirements. Delineate requirements for multiple birth attendants present at the same birth, one must be designated as the primary birth attendant. Require risk assessment criteria be provided with the patient disclosure form and signature/date of client attesting to receipt and understanding of the emergency transport plan. Requires LDM to maintain current certification in cardiopulmonary resuscitation for adults and infants and current certification in neonatal resuscitation and register all births with Department of Human Services (DHS) Vital Records Section. Remove DHS requirements regarding vitamin K and ophthalmic prophylaxis and add to mother and baby practice standards under newborn care.

Amendments made to risk assessment practice standards to align with midwifery and medical standards for client safety including mother and baby. Additions made to “absolute risk” where “transfer of care” for the mother and/or baby is required. “Absolute risk” has been made more inclusive to reflect the potential or actual risk that some situations or special circumstances may impose in an out-of-hospital birth including certain breech presentation, multiple gestation, post dates and vaginal birth after cesarean. Additions made to “non-absolute risk” where the licensee must “transfer care” or consult, discuss and document discussion of information including contrary actions. Clarification made to “non-absolute risk” include defining transfer of care, consultation and Oregon licensed health care provider to ensure licensees have clear guidelines and expectations.

Align mother and baby practice standards, previously standards of care, with current industry standards by referencing the current Midwifery Alliance of North America (MANA) core competencies, including antepartum, intrapartum and newborn care. Provide guidelines for fetal surveillance testing by 41 weeks and three days and establish procedure for evaluating fetal heart rate. Clarify declining protcols to include mother declining vitamin K and ophthalmic prophylaxis and DHS rule reference and requirements.

Align legend drugs and devices with current industry standards including adding instruments for completing a repair to the list of approved devices.

Adopt rule to clarify licensee’s requirements for records of care practice standards including readability, maintenance and content.

Adopt rule to establish requirements for informed consent and risk information practice standards including defining informed consent to mean, “the consent obtained following a thorough and easily understood explanation of the information to the mother or mother’s guardian.” The rule provides guidelines for how and what information must be provided to mother. Requires that LDM provide each mother with risk information regarding an out-of hospital birth and special circumstance birth including breech, twin and multiple gestation, vaginal birth after cesarean, and post date birth. The risk information would be standardized and updated by the board and the agency. Requirements for risk information would begin on June 1, 2011.

Adopt rule to provide guidance to licensees regarding practice standards for terminating midwifery care in a non-emergency and emergency situation. Rule clarifies the LDM’s role if the mother refuses transfer of care.

Rules Coordinator: Samantha Patnode—(503) 373-1917

332-025-0020

General Practice Standards

Pursuant to ORS 687.480, licensees must comply with the following practice standards when, advising the mother and in rendering antepartum, intrapartum and postpartum care.

(1) A licensee must include the designation LDM after the licensee’s name when completing birth certificates; and

(2) As a condition of license renewal, licensees must participate in peer review meetings in their regions or in conjunction with professional organization meeting(s), which must include, but are not limited to, the discussion of cases and obtaining feedback and suggestions regarding care. Documentation must be made on forms approved by the board. Licensees must participate in peer review according to the following schedule:

(a) Once per year if the licensee served as the primary birth attendant at 40 or fewer births during the license year; or

(b) Twice per year if the licensee served as the primary birth attendant at more than 40 births during the license year.

(c) For the purpose of reporting peer review, if there is more than one birth attendant present at the same birth, the birth attendants must designate which birth attendant is primary.

(3) In accordance with ORS 687.480 and 687.493 a licensee must maintain equipment necessary to: assess maternal, fetal and newborn well being; maintain aseptic technique; respond to emergencies requiring immediate attention; and to resuscitate mother and newborn when attending an out-of-hospital birth.

(4) A licensee must dispose of pathological waste resulting from the birth process in accordance with the Department of Human Services Public Health Division under OAR 333 Division 056. Provisions include:

(a) Incineration, provided the waste is properly containerized at the point of generation and transported without compaction to the site of incineration; or

(b) Burial on private property if burial of human remains on such property is not prohibited or regulated by a local government unit at the designated site.

(5) Licensees must dispose of biological waste materials that come into contact with blood and/or body fluids in a sealable plastic bag (separate from sealable trash or garbage liners) or in a manner that protects the licensee, mother, baby, and others who may come into contact with the material during disposal. Biological wastes may also be incinerated or autoclaved in equipment dedicated to treatment of infectious wastes.

(6) Licensees must dispose of sharps that come into contact with blood or bodily fluids in a sealable, (puncture proof) container that is strong enough to protect the licensee, mother, baby and others from accidental cuts or puncture wounds during the disposal process.

(7) Sharps must be placed into appropriate containers at the point of generation and may be transported without compaction to a landfill having an area designed for sharps burial or transported to an appropriate health care facility equipped to handle sharps disposal, provided the lid of the container is tightly closed or taped to prevent the loss of content and the container is appropriately labeled.

(8) Licensees must maintain a “patient disclosure form” providing current and accurate information to prospective clients. Licensees must provide the mother with this information. This statement must include, but is not limited to:

(a) Philosophy of care;

(b) Midwifery training and education;

(d) Services provided to mother and baby;

(e) Types of emergency medications and equipment used;

(f) Responsibilities of the mother and her family;

(g) Fees for services including financial arrangements;

(h) Malpractice coverage;

(i) Risk assessment criteria as listed in OAR 332-025-0021; and

(j) Signature of mother and date of signature documenting discussion and receipt of patient disclosure form.

(9) A licensee must maintain a plan for emergency transport and must discuss the plan with the mother. The plan must include, but is not limited to:

(a) Place of transport;

(b) Mode of transport;

(d) Availability of private vehicle or ambulance including emergency delivery equipment carried in the vehicle.

(10) Signature of mother and date of signature documenting discussion of emergency transport plan must be placed in the mother’s record.

(11) A licensee must maintain complete and accurate written records documenting the course of midwifery care as listed under OAR 332-025-0070.

(12) A licensee must maintain current certification in cardiopulmonary resuscitation for adults and infants and current certification in neonatal resuscitation.

(13) All births must be registered with the Department of Human Services Vital Records Section, as provided in ORS chapter 432.

Stat. Auth.: ORS 676.605, 676.615, 687.480 & 687.485

Stats. Implemented: ORS 676.605, 676.615, 687.480 & 687.485

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 2-1998, f. 4-14-98, cert. ef. 4-15-98; DEM 1-1999(Temp), f. 9-1-99, cert. ef. 9-9-99 thru 2-29-00; DEM 2-1999, f. 12-17-99, cert. ef. 12-20-99; DEM 2-2000(Temp), f. 8-22-00, cert. ef. 8-22-00 thru 2-17-00; DEM 2-2000(Temp), f. 8-22-00, cert. ef. 8-22-00 thru 2-17-01; DEM 3-2000, f. 9-29-00, cert. ef. 10-1-00; DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; Administrative correction 11-7-01; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0021

Risk Assessment Practice Standards

Licensees must assess the appropriateness of an out-of-hospital birth taking into account the health and condition of the mother and baby according to the following absolute and non-absolute risk criteria:

(1) “Absolute risk” as used in this rule means conditions or clinical situations of obstetrical or neonatal risk that cannot be resolved and that preclude out-of-hospital birth. If the mother or baby presents with any absolute risk factors, the LDM must:

(a) During the antepartum period, plan for transfer of care and an in-hospital birth;

(b) During the intrapartum period, arrange transportation to the hospital and transfer of care unless the birth is imminent;

(c) When the birth is imminent, take the health and condition of the mother and baby and conditions for transport into consideration in determining whether to proceed with out-of-hospital birth or to arrange for transportation to a hospital and transfer of care;

(d) During the postpartum period, arrange for transportation of mother or baby to a hospital and transfer of care;

(2) The following constitute absolute risk factors:

(a) ANTEPARTUM ABSOLUTE RISK CRITERIA:

(A) Active cancer;

(B) Cardiac condition with hemodynamic consequences;

(D) Severe liver disease — active or chronic;

(E) Uncontrolled hyperthyroidism;

(F) Chronic obstructive pulmonary disease;

(G) Essential chronic hypertension over 140/90;

(H) Pre-eclampsia/eclampsia;

(I) Current venous thromboembolic disease;

(J) Current substance abuse known to cause adverse effects for the mother or baby;

(K) Incomplete spontaneous abortion;

(L) Hemoglobin under nine at term;

(M) Placental abruption;

(N) Placenta less than 2.0 centimeters from internal os at onset of labor;

(O) Persistently or severely abnormal quantity of amniotic fluid;

(P) Signs and symptoms of chorioamnionitis;

(Q) Ectopic pregnancy;

(R) Pregnancy lasting longer than 43 weeks gestation (21 days past the due date);

(S) Any pregnancy with abnormal fetal surveillance tests;

(T) Active acquired immune deficiency syndrome (AIDS);

(U) Higher order multiples (three or more);

(V) Monochorionic, monoamniotic twins;

(W) Twin-to-twin transfusion;

(X) Presenting twin transverse;

(Y) Three cesarean sections unless previous successful vaginal birth;

(Z) Placenta accreta, percreta or increta;

(AA) Non-cephalic presentation except as noted in non-absolute risk criteria;

(BB) Previous classical uterine incision, T-incision, prior uterine rupture or extensive transfundal surgery;

(CC) Four or more cesarean sections; and

(DD) Pre-existing diabetes requiring oral medication or insulin.

(b) INTRAPARTUM ABSOLUTE RISK CRITERIA:

(A) Documented intrauterine growth restriction at term;

(B) Suspected uterine rupture;

(D) Suspected complete or partial placental abruption;

(E) Suspected placenta previa;

(F) Signs and symptoms of chorioamnionitis;

(G) Pre-eclampsia/eclampsia;

(H) Thick meconium-stained amniotic fluid without reassuring fetal heart tones and birth is not imminent;

(I) Evidence of fetal distress or abnormal fetal heart rate pattern unresponsive to treatment or inability to auscultate fetal heart tones;

(J) Excessive vomiting, dehydration, acidosis or exhaustion unresponsive to treatment;

(K) Blood pressure greater than or equal to 150/100 which persists or rises, and birth is not imminent;

(L) Labor or premature rupture of membrane less than 35 weeks according to estimated due date;

(M) Current substance abuse known to cause adverse effects for the mother or baby;

(N) Retained placenta with suspected placenta accreta;

(O) Active herpes lesion in an unprotectable area;

(P) Primary herpes outbreak in labor; and

(Q) Footling breech when a foot or knee is presenting, except if well applied to the buttocks, as determined by vaginal examination.

(A) Retained placenta with suspected placenta accreta;

(B) Retained placenta with abnormal or significant bleeding;

(D) Uncontrolled postpartum bleeding;

(E) Increasingly painful or enlarging hematoma;

(F) Development of pre-eclampsia; and

(G) Signs or symptoms of shock unresponsive to treatment.

(d) INFANT ABSOLUTE RISK CRITERIA:

(A) Apgar less than 7 at 10 minutes of age;

(B) Respiration rate greater than 100 within the first two hours postpartum, and greater than 80 thereafter, lasting more than one hour without improvement;

(D) Seizures;

(E) Apnea;

(F) Central cyanosis;

(G) Large or distended abdomen;

(H) Any condition requiring more than 12 hours of observation postbirth;

(I) Persistent poor suck, hypotonia or a weak or high-pitched cry;

(J) Persistent inability to maintain temperature between 97-100 degrees Fahrenheit;

(K) Persistent projectile vomiting or emesis of fresh blood; and

(L) Signs and symptoms of infection in the infant.

(3) “Non-absolute” means a condition or clinical situation that places a mother or baby at increased obstetric or neonatal risk, but does not automatically exclude a mother and baby from an out-of-hospital birth.

(4) When a mother or baby presents with one or more non-absolute risk factors, the LDM must:

(a) Arrange for the transfer of care of the mother or baby; or

(b) Comply with all of the following:

(A) Consult with at least one Oregon licensed health care provider regarding the non-absolute risk factors present.

(B) Discuss the non-absolute risk(s) with the mother, including:

(i) Possible adverse outcomes;

(ii) Whether an out-of-hospital birth is a reasonably safe option based upon the risk(s) present;

(iii) The anticipated risk(s) and the likelihood of reducing or eliminating said risks;

(iv) The midwife’s experience with said risk(s);

(v) The ease and time involved in accomplishing transport or transfer of care;

(vi) Recommendation(s) given by the consulting Oregon licensed health care provider(s); and

(vii) Recommendation(s) given by the LDM to the mother.

(D) To the extent the LDM acts contrary to the recommendations given by the consulting Oregon licensed health care provider, the LDM must document the justification.

(E) Informed consent must be obtained and documented in records.

(5) The following are non-absolute risk factors:

(a) MATERNAL ANTEPARTUM NON-ABSOLUTE RISK CRITERIA:

(A) Conditions that could negatively affect maternal or fetal status that require ongoing medical supervision or ongoing use of medications;

(B) Inappropriate fetal size for gestation;

(D) Abnormal fetal cardiac rate or rhythm;

(E) Decreased fetal movement;

(F) Uterine anomaly;

(G) Anemia (hematocrit less than 30 or hemoglobin less than 10 at term);

(H) Seizure disorder requiring prescriptive medication;

(I) Platelet count of less than 75,000;

(J) Isoimmunization to blood factors;

(K) Psychiatric disorders;

(L) History of thrombophlebitis and hemoglobinopathies;

(M) Dichorionic, diamniotic twins;

(N) Monochorionic, diamniotic twins;

(O) Known fetal anomalies that require medical attention at birth;

(P) Two cesarean sections without previous successful vaginal birth;

(Q) Three cesarean sections with a previous successful vaginal birth;

(R) Blood coagulation defect;

(S) Significant glucose intolerance unresponsive to dietary and exercise intervention;

(T) Gestational diabetes well controlled with diet or oral glycemic medications; and

(U) Primary herpes outbreak.

(b) INTRAPARTUM NON-ABSOLUTE RISK CRITERIA:

(A) No prenatal care or unavailable records;

(B) History of substance abuse during this pregnancy;

(C) Signs and symptoms of infection including but not limited to a temperature 100.4 degrees Fahrenheit or higher with adequate hydration in the mother;

(D) Labor or premature rupture of membrane from 35 to 36 weeks gestation;

(E) Frank and complete breech presentation, as determined by vaginal examination;

(F) Lack of adequate progress in second stage:

(i) Lack of adequate progress in vertex presentation is when there is no progress after a maximum of three hours in cases with full dilation, ruptured membranes, strong contractions and sufficient maternal effort; and

(ii) Lack of adequate progress in breech presentation is when there is no progress in descent after a maximum of one hour in cases with full dilation, ruptured membranes, strong contractions and sufficient maternal effort.

(A) Signs and symptoms of infection;

(B) Any condition requiring more than 12 hours of postpartum observation;

(D) Evidence of urinary retention that cannot be resolved in an out-of- hospital setting; and

(E) Third-degree lacerations if LDM is qualified and has documented training.

(d) INFANT NON-ABSOLUTE RISK CRITERIA:

(A) Apgar less than 7 at five minutes without improvement;

(B) Weight less than 2,270 grams (five lbs.);

(D) Excessive pallor, ruddiness, or jaundice at birth;

(E) Any generalized rash at birth;

(F) Birth injury such as facial or brachial palsy, suspected fracture or severe bruising;

(G) Baby with signs and symptoms of hypoglycemia unresolved in the out-of-hospital setting;

(H) Weight decrease in excess of 10 percent of birth weight that does not respond to treatment;

(I) Maternal-infant interaction problems;

(J) Direct Coomb’s positive cord blood;

(K) Infant born to HIV positive mother;

(L) Suspected or evident major congenital anomaly;

(M) Estimated gestational age of less than 35 weeks;

(N) Maternal substance abuse identified postpartum; and

(O) Cardiac irregularities, heart rate less than 80 or greater than 160 (at rest) without improvement, or any other abnormal or questionable cardiac findings.

(6) For the purpose of this rule “transfer of care” means the process whereby any LDM who has been providing care relinquishes this responsibility to a hospital or to licensees under ORS chapter 682.

(a) The LDM must provide the following at the time of transfer, to the hospital or licensees under ORS chapter 682: medical history, prenatal flow sheet, diagnostic studies, laboratory findings, and maternal and baby care notes through time of transfer;

(b) In cases of emergency, at the time of transfer, the LDM must provide the records required in subsection (a) to the hospital or licensees under ORS chapter 682, including notes for care provided during the emergency, if available. If notes are not available, an oral summary of care during the emergency must be made available to the hospital or licensees under ORS chapter 682; and

(c) Under no circumstances shall the midwife leave the mother or baby until such a time that transport is arranged and another Oregon licensed health care provider or a licensee under ORS chapter 682 assumes care.

(7) For the purpose of this rule “consultation” means a dialogue for the purpose of obtaining information or advice from an Oregon licensed health care provider who has direct experience handling complications of the risk(s) present, as well as the ability to confirm the non-absolute risk, which may include, but is not limited to confirmation of a diagnosis and recommendation regarding management of medical, obstetric, or fetal problems or conditions. Consultation may be by phone, in person or in writing.

(8) For the purpose of this rule “Oregon licensed health care provider” means a physician or physician assistant licensed under ORS 677, a certified nurse midwife or nurse practitioner licensed under ORS 678, a naturopath licensed under ORS 685, or a licensee under ORS 687.

Stat. Auth.: ORS 676.605, 676.615, 687.480 & 687.485

Stats. Implemented: ORS 676.605, 676.615, 687.480 & 687.485

332-025-0022

Mother and Baby Care Practice Standards

(1) An LDM may:

(a) Order and receive laboratory and ultrasound results;

(b) Fit barrier methods of contraception at the six-week check up, if qualified to fit barrier methods of contraception.

(2) For mother and baby care practice standards the agency and board adopt by reference the MANA core competencies, current version as approved by MANA. Reference http://mana.org/manacore.html for current version.

(3) In addition to and not in lieu of the MANA core competencies, an LDM must adhere to the following mother and baby care practice standards:

(a) Care During Pregnancy (Antepartum) - The LDM must:

(A) Provide health care, support and information to the mother throughout pregnancy;

(B) Determine the need for consultation or referral as appropriate;

(D) Assess, identify, evaluate and support maternal and fetal well-being throughout the process of pregnancy;

(E) Thoroughly educate and counsel mother regarding the childbearing cycle;

(F) Identify preexisting conditions in a woman’s health history that are likely to influence her well-being when she becomes pregnant;

(G) Educate mother regarding nutritional requirements of pregnant mother and provide methods of nutritional assessment and counseling;

(H) Educate mother regarding changes in emotional, psychosocial and sexual variations that may occur during pregnancy;

(I) Identify and educate mother regarding environmental and occupational hazards for pregnant mother.

(J) Educate mother regarding genetic factors that may indicate the need for counseling, testing or referral;

(K) Educate mother regarding the growth and development of the unborn baby;

(L) Identify and educate mother regarding indications for, risks and benefits of bio-technical screening methods and diagnostic tests used during pregnancy;

(M) Educate mother regarding anatomy, physiology and evaluation of the soft and bony structures of the pelvis;

(N) Exercise palpation skills for evaluation of the fetus and uterus;

(O) Assess and educate mother regarding causes and treatment of the common discomforts of pregnancy;

(P) Identify implications of and appropriate treatment for various infections, disease conditions and other problems that may affect pregnancy;

(Q) Identify and educate of special needs of the Rh(D)-negative woman;

(R) Arrange for fetal surveillance testing by 41 weeks and three days by recommending one or more of the following:

(i) Biophysical profile weekly and non-stress test bi-weekly; or

(ii) Amniotic fluid index and non-stress test bi-weekly;

(b) Care During Labor, Birth and Immediately Thereafter (Intrapartum) — the LDM must:

(A) Provide health care, support and information to the mother throughout labor, birth and the hours immediately thereafter;

(B) Determine the need for consultation or referral as appropriate;

(D) Evaluate maternal and fetal well-being during labor, birth and immediately thereafter, including relevant historical data;

(E) For mothers and babies without signs of risk factors, during the active phase of the first stage of labor, evaluate the fetal heart rate at least every 30 to 60 minutes, listening toward the end of a contraction and for at least 30 seconds after;

(F) For mothers and babies with risk factors, auscultate fetal heart tones more frequently than every 30 to 60 minutes and listen through contractions as indicated in the active stage of labor;

(G) Auscultate fetal heart tones approximately every 5 to 10 minutes or after every contraction, as indicated, with active pushing;

(H) Assess birthing environment, assuring that it is clean, safe and supportive, and that appropriate equipment and supplies are on hand;

(I) Assess emotional responses and their impact during labor, birth and immediately thereafter;

(J) Provide comfort and support measures during labor, birth and immediately thereafter;

(K) Evaluate fetal and maternal anatomy and their interactions as relevant to assessing fetal position and the progress of labor;

(L) Utilize techniques to assist and support the spontaneous vaginal birth of the baby and placenta;

(M) Assess and meet fluid and nutritional requirements during labor, birth and immediately thereafter;

(N) Assess and support maternal rest and sleep as appropriate during the process of labor, birth and immediately thereafter;

(O) Assess causes of, evaluate and treat variations that occur during the course of labor, birth and immediately thereafter;

(P) Provide appropriate support for the newborn’s transition during the first minutes and hours following birth;

(Q) Evaluate and care for perineum and surrounding tissues; and

(R) Before the LDM leaves or the family is discharged, the placenta must be delivered and the mother’s general condition, blood pressure, pulse, temperature, fundus, lochia, and ability to ambulate and urinate must be assessed. Mother’s and baby’s condition must be found to be within normal limits.

(A) Provide health care, support and information to the mother throughout the postpartum period;

(B) Determine the need for consultation or referral as appropriate;

(D) Educate mother regarding lactation support and appropriate breast care including evaluation of, identification of and treatments for problems with nursing;

(E) Evaluate and promote maternal well-being;

(F) Assess causes of, evaluate and treat maternal discomfort;

(G) Evaluate and educate emotional, psychosocial and sexual variations;

(H) Monitor and educate mother regarding maternal nutritional requirements during including methods of nutritional evaluation and counseling;

(I) Assess causes of, evaluate and treat problems arising during the postpartum period, consulting as necessary;

(J) Provide family with written and verbal postpartum instructions; and

(K) Provide support, information and referral for family planning methods, as the individual woman desires.

(d) Newborn Care — The LDM must:

(A) Provide health care to the newborn;

(B) Provide support and information to parents regarding newborn care;

(D) Evaluate anatomy and physiology of newborn and support of the newborn’s adjustment during the first days and weeks of life;

(E) Evaluate newborn wellness including relevant historical data and gestational age;

(F) Assess and educate the mother regarding nutritional needs of the newborn;

(G) Educate mother regarding state laws concerning indications for, administration of, and the risks and benefits of prophylactic bio-technical treatments and screening tests commonly used during the neonatal period;

(H) Educate mother regarding causes of, assessment of, appropriate treatment and emergency measures for newborn problems and abnormalities;

(I) Adhere to state guidelines for the administration of vitamin K and ophthalmic prophylaxis pursuant to ORS 433.306 and OAR 333-021-0800; and

(J) Ensure infant metabolic screening is performed and documented according to the Department of Human Services recommendations unless the mother declines, as provided ORS Chapter 432 and OAR 333-024-0205 through 0235.

(4) Declined Procedure: In the event the mother refuses any testing or procedures required by administrative rule or recommended by the LDM, the LDM must document discussion with the mother of why the test or procedure is required or recommended, and document the mother’s refusal of the test or procedures, including the mother’s signature in the chart. In addition, the LDM must follow the requirements of ORS Chapter 432, 433.306, OAR 333-021-0800 and 333-024-0205 through 0235 when the mother declines administration of vitamin K or infant metabolic screening.

Stat. Auth.: 676.605, 676.615, 687.480 & 687.485

Stats. Implemented: 676.605, 676.615, 687.480 & 687.485

332-025-0030

Access to and Administration of Legend Drugs and Devices

Pursuant to ORS 687.493, an LDM who satisfactorily completes the prescribed education outlined in OAR 332-015-0070 is authorized access to and administration of specific legend drugs and devices listed in OAR 332-025-0040, 332-025-0050, and 332-025-0060. The following requirements must be adhered to:

(1) Licensees must comply with all local, state and federal laws and regulations regarding the administration, distribution, storage, transportation and disposal of approved legend drugs and devices listed in OAR 332-025-0040 through 332-025-0060.

(2) Approved legend drugs must be inventoried and securely stored by the LDM at all times the product is not in use, including samples or any remaining portion of a drug.

(3) Records regarding approved legend drugs and devices must be maintained for a period of three years. Records must be kept on the business premises and available for inspection upon request by the Oregon Health Licensing Agency Enforcement Officers. Upon request by the board or agency, an LDM must provide a copy of records. Records must include, but are not limited, to the following:

(a) Name of drug, amount received, date of receipt, and drug expiration date;

(b) Name of drug and to whom it was administered; date and amount of drug administered to client;

(4) Expired, deteriorated or unused legend drugs must be disposed of in a manner that protects the licensee, client and others who may come into contact with the material during disposal.

Stat. Auth.: ORS 676.605, 676.615, 687.485, 687.493

Stats. Implemented: ORS 676.605, 676.615, 687.485, 687.493

Hist.: DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0040

Approved Legend Drugs For Maternal Use

Licensees may administer the following legend drugs as approved by the board for maternal use:

(1) Anti-Hemorrhagics for use by intramuscular injection includes:

(a) Synthetic Oxytocin (Pitocin, Syntocin and generic);

(b) Methylergonovine (Methergine);

(2) Anti-Hemorrhagics by intravenous infusion is limited to Synthetic Oxytocin (Pitocin, Syntocin, and generic).

(3) Anti-Hemorrhagics for oral administration is limited to:

(a) Methylergonovine (Methergine);

(b) Misoprostol (Cytotec).

(4) Anti-Hemorrhagics for rectal administration is limited to Misoprostol (Cytotec).

(5) Resuscitation is limited to medical oxygen and intravenous fluid replacement.

(6) Intravenous fluid replacement includes:

(a) Lactated Ringers Solution;

(b) 0.9% Saline Solution;

(d) D5W (5% Dextrose in water).

(7) Anaphylactic treatment by subcutaneous injection is limited to Epinephrine.

(8) Local anesthetic includes:

(a) Lidocaine HCl (1% and 2%) (Xylocaine and generic);

(b) Topical anesthetic;

(d) Sterile water papules.

(9) Rhesus Sensitivity Prophylaxis is limited to Rho(d) Immune Globulin (RhoGAM, Gamulin Rh, Bay Rho-D and others).

(10) Tissue adhesive (Dermabond or generic).

Stat. Auth.: ORS 676.605, 676.615, 687.485 & 687.493

Stats. Implemented: ORS 676.605, 676.615, 687.485 7 687.493

Hist.: DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0050

Approved Legend Drugs For Neonatal Use

Licensees may administer the following legend drugs as approved by the board for neonatal use:

(1) Eye Prophylaxis for disease of the newborn is limited to Erythromycin Ophthalmic (0.5%) Ointment (Ilotycin, AK-Mycin and generics).

(2) Prophylaxis for hemorrhagic disease of the newborn for oral use is limited to Mephyton.

(3) Prophylaxis for hemorrhagic disease of the newborn for intramuscular injection includes:

(a) AquaMephyton; and

(b) Konakion.

(4) Resuscitation is limited to medical oxygen.

Stat. Auth.: ORS 676.605, 676.615, 687.485 & 687.493

Stats. Implemented: ORS 676.605, 676.615, 687.485 & 687.493

Hist.: DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0060

Approved Devices

Licensees may use or provide as appropriate the following devices as approved by the board:

(1) Devices for injection of medications including:

(a) Needles; and

(b) Syringes.

(2) Devices for administration of intravenous fluids including:

(a) Drip sets; and

(b) Catheters.

(3) Devices for maternal and neonatal resuscitation including:

(a) Suction devices;

(b) Oxygen-delivery devices; and

(4) Devices for rupturing the amniotic sac.

(5) Devices for repairing the perineal area including:

(a) Sutures;

(b) Instruments for completing a repair; and

(6) Barrier methods of contraception.

Stat. Auth.: ORS 183, 487.485 & 687.493

Stats. Implemented: ORS 183, 687.485 & 687.493

Hist.: DEM 1-2001(Temp), f. & cert. ef. 10-1-01 thru 3-29-02; DEM 1-2002, f. 2-25-02 cert. ef. 3-1-02; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0070

Records of Care Practice Standards

(1) The LDM must maintain complete and accurate records of each mother and baby.

(2) Records mean written documentation, including but not limited to:

(a) Midwifery care provided to mother and baby;

(b) Demographic information;

(d) Diagnostic studies and laboratory findings;

(e) Emergency transport plan defined under OAR 332-025-0020;

(f) Informed consent and risk information documentation under OAR 332-025-0080;

(g) Health Insurance Portability and Accountability Act (HIPAA) releases;

(h) Description of the reasoning for transfer of care defined under OAR 332-025-0021 of the mother and baby;

(i) Documentation of all consultations and recommendations from health care providers as defined under OAR 332-015-0000;

(j) Documentation of all consultations and recommendations regarding non-absolute risk factors from Oregon licensed health care providers as defined under OAR 332-025-0021;

(k) Documentation of any declined procedures under OAR 332-025-0022;

(l) Documentation of termination of care under OAR 332-025-0100; and

(m) Documentation that the patient disclosure form has been received by the mother under OAR 332-025-0020.

(3) Records must be maintained for no less than seven years. All records are subject to review by the agency.

(4) All records must be legibly written or typed, dated and signed.

(5) All records must include a signature or initial of the LDM.

Stat. Auth.: ORS 487.485 & 676.615

Stats. Implemented: ORS 687.425, 687.480, 687.485, 676.606 & 676.607

Hist.: DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0080

Informed Consent and Risk Information Practice Standards

(1) Informed consent means the consent obtained following a thorough and easily understood explanation of the information to the mother or mother’s guardian.

(2) The explanation must be both verbal and written.

(3) An LDM must document the verbal explanation and the written informed consent process in the client’s record. Informed consent information must include the following:

(a) Definition of procedure or process;

(b) Benefits of procedure or process;

(d) Description of adverse outcomes;

(e) Risk of adverse outcomes; and

(f) Alternative procedures or processes and any risk(s) associated with them.

(4) An LDM must obtain mother’s dated signature acknowledging she has received, reviewed, and understands the information, and has made an informed choice.

(5) Beginning on June 1, 2011, each LDM must provide risk information as published on the agency’s website www.Oregon.gov/OHLA, and obtain informed consent for the following circumstances:

(a) Out-of-hospital birth;

(b) Vaginal birth after cesarean (VBAC);

(d) Multiple gestations; and

(e) Pregnancy exceeding 42 weeks gestation.

Stat. Auth.: ORS 487.485 & 676.615

Stats. Implemented: ORS 687.425, 687.480, 687.485, 676.606 & 676.607

Hist.: DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-025-0100

Practice Standards for Terminating Midwifery Care

(1) The procedure for terminating midwifery care in a non-emergent situation is as follows:

(a) Provide written notice no fewer than three business days as postmarked, unless the mother is in labor or during an emergency, at which time the LDM must continue to provide midwifery care until another provider assumes care;

(b) Notice must be sent to the last known address of the mother by certified mail, return receipt requested, as well as by regular mail.

(2) To terminate midwifery care in an emergency, the LDM must activate the 911 emergency system and transfer care to a licensee under ORS chapter 682.

(3) An LDM in the home setting may leave after transferring care to a licensee under ORS Chapter 682.

(4) If the mother refuses assistance from licensees under ORS chapter 682 the LDM must continually urge the mother to transfer care to a licensee under ORS Chapter 682 and may:

(a) Continue care to save a life; and

(b) Only perform actions within the technical ability of the LDM.

(5) If the mother loses consciousness, the LDM must activate the 911 emergency system and transfer care to a licensee under ORS Chapter 682.

Stat. Auth.: ORS 487.485 & 676.615

Stats. Implemented: ORS 687.425, 687.480, 687.485, 676.606 & 676.607

Hist.: DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

332-030-0000

Investigative Authority

The Oregon Health Licensing Agency may initiate and conduct investigations of matters relating to the practice of direct entry midwifery, pursuant to ORS 676.608, and may take appropriate disciplinary action in accordance with the provisions of ORS 676.612 and 687.445.

Stat. Auth.: ORS 676.608 & 687.445

Stats. Implemented: ORS 676.608 & 687.445

Hist.: DEM 1-1993(Temp), f. & cert. ef. 12-22-93; DEM 1-1994, f. & cert. ef. 6-15-94; DEM 1-2000(Temp), f. 7-14-00, cert. ef. 7-15-00 thru 12-1-00; DEM 4-2000, f. 9-29-00, cert. ef. 10-1-00; DEM 1-2004, f. 6-29-04, cert. ef. 7-1-04; DEM 6-2010, f. 12-30-10, cert. ef. 1-1-11

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2010.