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TITLE 844 MEDICAL LICENSING BOARD OF INDIANA

Final Rule
LSA Document #15-448(F)

DIGEST

Adds 844 IAC 17 to establish requirements for certification, certification fees, continuing education requirements, peer review procedures, collaboration requirements, standards of competent practice, and emergency plans for certified direct entry midwives. Effective 30 days after filing with the Publisher.



SECTION 1. 844 IAC 17 IS ADDED TO READ AS FOLLOWS:

ARTICLE 17. CERTIFIED DIRECT ENTRY MIDWIVES


Rule 1. Certified Direct Entry Midwives


844 IAC 17-1-1 Scope

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 1. This rule establishes requirements for certification, certification fees, continuing education requirements, peer review procedures, collaboration requirements, standards of competent practice, and emergency care plans for certified direct entry midwives.
(Medical Licensing Board of Indiana; 844 IAC 17-1-1; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-2 Definitions

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 2. The definitions in IC 25-23.4-1 apply throughout this rule.
(Medical Licensing Board of Indiana; 844 IAC 17-1-2; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-3 Application requirements

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 3. (a) An applicant for certification as a certified direct entry midwife shall file an application on a form supplied by the board and submit the fees required by section 4 of this rule.

(b) In addition to the requirements of IC 25-23.4-3-1, the applicant for certification shall provide the following:
(1) A notarized or certified copy of the applicant's Certified Professional Midwife credentials conferred by the North American Registry of Midwives or its successor organization.
(2) A certified copy of the original postsecondary educational institution diploma from which the applicant graduated. The following are requirements in the event that such diploma has been lost or destroyed:
(A) The applicant shall submit, in lieu thereof, a statement under the signature and seal of the dean of the postsecondary educational institution from which the applicant graduated, stating that the applicant has satisfactorily completed the prescribed course of study, the actual degree conferred, and the date of graduation.
(B) The applicant shall submit an affidavit fully and clearly stating the circumstances under which his or her diploma was lost or destroyed.
(C) In exceptional circumstances, the board may accept, in lieu of a diploma or certified copy thereof, other types of evidence, which establish that the applicant received a diploma and completed all academic requirements relating thereto.
(3) An original transcript of the applicant's postsecondary education, including the degree conferred and the date the degree was conferred. If an original transcript is not available, the applicant must submit the following:
(A) A notarized or certified copy of the original transcript, which must include the degree conferred and the date the degree was conferred.
(B) An affidavit fully and clearly stating the reasons that an original transcript is not available.
(4) The applicant shall submit evidence of the following to the board:
(A) Satisfactory completion of an educational curriculum approved by the Midwifery Education Accreditation Council or a successor organization, or the educational equivalent of a Midwifery Education Accreditation Council curriculum approved by the board.
(B) Documented practical experience as outlined in the Certified Professional Midwife credentialing process in accordance with the standards of the North American Registry of Midwives or a successor organization.
(C) Certification in adult cardiopulmonary resuscitation conferred by an accredited association approved by the board.
(D) Completion of the American Academy of Pediatrics program in neonatal resuscitation, excluding endotracheal intubation and the administration of drugs.
(E) Completion of the Certified Professional Midwife credentialing process birth requirements, observation of an additional twenty (20) births, attendance at an additional twenty (20) births conducted by a physician, assistance with an additional twenty (20) births, and acting as the primary attendant for an additional twenty (20) births. The additional births must take place in the United States, and all births except the additional twenty (20) births conducted by a physician, must be overseen by a preceptor approved by the North American Registry of Midwives.
(F) Completion of an emergency skills training course approved by the North American Registry of Midwives for inclusion in the Midwifery Bridge Certificate Program, which includes course material as required by IC 25-23.4-3-2(2).
(G) Proof of maintaining a liability insurance policy that at a minimum provides coverage of one hundred thousand dollars ($100,000) per incident and three hundred thousand dollars ($300,000) yearly aggregate.
(5) Where the name on any document differs from the applicant's name, a notarized or certified copy of a marriage certificate or legal proof of name change must be submitted with the application.
(6) All applicants who are now, or have been, licensed to practice any health profession in another state must submit verification of license status. This information must be sent by the state that issued the license directly to the board.
(Medical Licensing Board of Indiana; 844 IAC 17-1-3; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-4 Fees

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 4. Every applicant for certification as a certified direct entry midwife shall pay to the agency the following fees:
  Initial certification fee  $50 
  Biennial renewal fee  $50 
(Medical Licensing Board of Indiana; 844 IAC 17-1-4; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-5 Certification renewal

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 5. Every certified direct entry midwife holding a certificate issued by the board shall renew such license with the board biennially.
(Medical Licensing Board of Indiana; 844 IAC 17-1-5; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-6 Continuing education requirements

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 6. (a) When renewing a certificate, each certified direct entry midwife shall provide to the board documentation of the successful annual completion of fifteen (15) hours of board approved continuing education credits, with:
(1) at least one (1) hour annually in pharmacology;
(2) at least one (1) hour every two (2) years in each of the following:
(A) Emergency life support procedures.
(B) Identification of high risk births for mothers.
(C) Identification of potential complications during labor.
At least fifty percent (50%) of these hours must be obtained from courses attended in person.

(b) In addition to courses offered or approved by an approved organization pursuant to IC 25-1-4-0.2, board approved continuing education courses include courses offered or approved by the following:
(1) Certifying bodies accepted by the North American Registry of Midwives.
(2) The Indiana Midwives Association.
(3) The American Academy of Pediatrics.
(4) The American College of Nurse Midwives.
(5) Other organizations who provide coursework relevant to the practice of midwifery as approved by the board.
(Medical Licensing Board of Indiana; 844 IAC 17-1-6; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-7 Peer review

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 7. (a) A certified direct entry midwife shall participate in an approved peer review session at least twice a year.

(b) An approved peer review session is a peer review session as follows:
(1) Sponsored by one (1) of the following organizations:
(A) The North American Registry of Midwives.
(B) The Indiana Midwives Association.
(C) The Association of Indiana Midwives.
(D) Any other state or national midwifery organization approved by the board.
(2) Where at least four (4) of the participants present are any of the following:
(A) A certified professional midwife.
(B) A certified direct entry midwife.
(C) A certified nurse midwife.

(c) In addition to the requirements of subsection (b), a certified direct entry midwife shall participate in and have reviewed in an approved peer review session, within six (6) months, any cases resulting in:
(1) death of a client or client's child;
(2) intrapartum or postpartum transport of a client from the planned delivery location to a hospital, urgent care center, physician's office, or similar facility for further care or treatment; or
(3) significant adverse event or injury to the client or client's child, whether temporary or permanent in nature.

(d) When renewing a certificate, a certified direct entry midwife shall attest under the penalties of perjury that they have participated in approved peer review sessions as required by this section.
(Medical Licensing Board of Indiana; 844 IAC 17-1-7; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-8 Physician collaboration requirements

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 8. (a) In addition to the requirements of IC 25-23.4-5, a certified direct entry midwife shall enter into a collaborative agreement with a physician holding an unrestricted license to practice medicine in Indiana. The collaborating physician shall be actively engaged in the practice of obstetrics and shall have staff membership privileges at the designated hospital in the client's emergency care plan, or have coverage arrangements with another physician who has obstetrical/gynecological privileges at the designated hospital.

(b) A collaborating physician may not enter into more than four (4) collaborative agreements, without board approval, at any given time.

(c) Unless the board approves otherwise, the planned location of a delivery attended by a certified direct entry midwife shall be either:
(1) within the county or adjoining county, or ninety (90) miles, whichever is further, from the collaborating physician's primary practice location; or
(2) within the county or adjoining county, or sixty (60) miles, whichever is further, from the hospital designated in the client's emergency care plan as the location where the client can receive emergency care.

(d) When considering whether to approve more than four (4) collaborative agreements, or to permit a longer distance between the collaborating physician's primary practice location or the hospital designated in the client's emergency care plan and the planned location of a delivery, the board shall consider the physician's ability to collaborate with the certified direct entry midwife in a manner that protects the client's safety. The burden is on the certified direct entry midwife and collaborating physician to establish that the collaboration will not be harmful to the client.

(e) A collaborating physician shall review a certified direct entry midwife's client encounters in accordance with IC 25-23.4-5-1. A collaborating physician shall also review all certified direct entry midwife's client encounters resulting in:
(1) death of a client or client's child;
(2) intrapartum or postpartum transport of a client from the planned delivery location to a hospital, urgent care center, physician's office, or similar facility for further care or treatment;
(3) significant adverse event or injury to the client or client's child, whether temporary or permanent in nature; or
(4) transfer of care if required by section 9 of this rule.

(f) Collaboration may occur in either face-to-face encounters, or by electronic or other telecommunication means.
(Medical Licensing Board of Indiana; 844 IAC 17-1-8; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-9 Referrals

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 9. (a) In addition to the requirements of this section and IC 25-23.4-6-1, a certified direct entry midwife shall refer for consultation or transfer care to a physician if there is a case, which in the judgment of the certified direct entry midwife or the collaborating physician, the client or the client's fetus is at risk of serious harm or injury, or any other case requiring care that exceeds the scope of the certified direct entry midwife's training or skill.

(b) A certified direct entry midwife shall refer for consultation or transfer care to a physician if any of the following prenatal conditions exist in either the client or the client's fetus:
(1) Active cancer.
(2) Cardiac disease.
(3) Severe renal disease.
(4) Severe liver disease.
(5) Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
(6) Uncontrolled hyperthyroidism.
(7) Chronic obstructive pulmonary disease (COPD).
(8) Seizure disorder requiring prescriptive medication.
(9) Severe psychiatric disorders requiring hospitalization or medication known to have adverse effects.
(10) Current substance abuse known to cause adverse effects.
(11) Chronic hypertension.
(12) Insulin dependent diabetes or uncontrolled gestational diabetes.
(13) Previous second trimester miscarriage.
(14) Previous premature delivery.
(15) Preterm rupture of membranes.
(16) Prior intrauterine growth retardation.
(17) Primary outbreak of genital herpes.
(18) Inappropriate fetal size for gestation as documented by ultrasound.
(19) Significant second or third trimester bleeding.
(20) Incomplete spontaneous abortion.
(21) Abnormal fetal cardiac rate or rhythm.
(22) Uterine anomaly.
(23) Suspected platelet disorder.
(24) Prior caesarean section or uterine surgery with a fundal incision or myomectomy, or both.
(25) Rh or other blood group isoimmunization.
(26) History of hemoglobinopathies.
(27) Acute or chronic deep vein thrombosis (DVT).
(28) Anemia where hematocrit is less than thirty (30) or hemoglobin is less than ten (10) at term.
(29) Blood coagulation defect.
(30) Preeclampsia or eclampsia.
(31) Uterine ablation.
(32) Placental abruption.
(33) Placenta previa or complete, marginal, or low-lying placenta after eighteen (18) weeks of gestation.
(34) Documented oligohydramnios or polyhydramnios.
(35) Suspected chorioamnionitis.
(36) Ectopic pregnancy.
(37) Pregnancy lasting longer than forty-two (42) weeks with an abnormal nonstress test.
(38) Abnormal fetal surveillance tests.
(39) Suspected malpresentation incompatible with vaginal delivery.
(40) Suspected multiple gestation.
(41) Suspected serious perinatal mood disorder; or
(42) Fetal demise.

(c) A certified direct entry midwife shall refer for consultation or transfer care to a physician if any of the following intrapartum conditions exist in either the client or the client's fetus:
(1) Current substance abuse.
(2) Documented intrauterine growth retardation (IUGR) or fetus small for gestational age (SGA) at term.
(3) Suspected uterine rupture.
(4) Active herpes lesion in a location that cannot be covered during delivery.
(5) Prolapsed cord or cord presentation.
(6) Suspected complete or partial placental abruption.
(7) Suspected placenta previa.
(8) Suspected chorioamnionitis.
(9) Preeclampsia or eclampsia.
(10) Thick meconium stained amniotic fluid without reassuring fetal heart tones when birth is not imminent.
(11) Suspected malpresentation incompatible with vaginal delivery unless birth is imminent.
(12) Abnormal auscultated fetal heart rate pattern unresponsive to treatment or inability to auscultate fetal heart tones.
(13) Excessive vomiting, dehydration, or exhaustion unresponsive to treatment.
(14) Blood pressure greater than 140/90 that persists or rises and birth is not imminent.
(15) Maternal fever equal to or greater than one hundred and four-tenths (100.4) degrees Fahrenheit.
(16) Labor or premature rupture of membranes (PROM) less than thirty-seven (37) weeks of gestation, documented by ultrasound or clinically calculated due date in the absence of ultrasound.

(d) A certified direct entry midwife shall refer for consultation or transfer care to a physician if any of the following maternal postpartum conditions exist:
(1) Undelivered placenta.
(2) Uncontrolled hemorrhage.
(3) Maternal shock.
(4) Signs of deep vein thrombosis (DVT).
(5) Subinvolution of the uterus.
(6) Repair of laceration beyond the skill of the certified direct entry midwife.
(7) Failure of laceration or episiotomy to heal and with signs of infection or breakdown.
(8) Infection requiring prescriptive therapy; or
(9) Severe perinatal mood disorder or psychosis.

(e) A certified direct entry midwife shall refer for consultation or transfer care to a physician if any of the following neonatal conditions exist:
(1) Persistent respiratory distress.
(2) Persistent pallor or central cyanosis.
(3) Jaundice within the first twenty-four (24) hours after birth.
(4) Hemorrhage.
(5) Signs of infection.
(6) Seizure.
(7) Major congenital anomaly not diagnosed prenatally.
(8) Unstable vital signs.
(9) Persistent hypotonia, lethargy, flaccidity, or irritability.
(10) Birth weight under five (5) pounds.
(11) Abnormal laboratory test results, including abnormal newborn screening results.
(12) Two (2) vessel cord.
(Medical Licensing Board of Indiana; 844 IAC 17-1-9; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-10 Collaborative agreements

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 10. (a) A collaborative agreement is a written document signed by the collaborating physician and the certified direct entry midwife that meets the following:
(1) Includes the:
(A) name;
(B) address; and
(C) phone number;
of the collaborating physician and the certified direct entry midwife.
(2) Describes the method or methods of collaboration, including a description of how often the physician will review client encounters of the certified direct entry midwife.
(3) Specifies the insurance coverage of the certified direct entry midwife.
(4) Includes a recitation of IC 25-23.4-8.
(5) Specifies the scope of services the certified direct entry midwife may provide.
(6) Specifies circumstances that are in addition to those specified under section 9 of this rule in which the certified direct entry midwife must refer or transfer care to the collaborating physician.

(b) Collaborative agreements shall be reviewed on an annual basis by the collaborating physician and certified direct entry midwife.

(c) A physician who enters into a collaborative agreement with a certified direct entry midwife shall:
(1) register with the board on a form prescribed by the board;
(2) file the written collaborative agreement; and
(3) submit a statement that the physician will collaborate with the certified direct entry midwife in accordance with this rule, pursuant to the provisions of IC 25-23.4-5-2.

(d) Any amendment to the collaborative agreement shall be submitted to the board, and the certified direct entry midwife may practice under any amended collaborative agreement unless the agreement has been denied by the board.
(Medical Licensing Board of Indiana; 844 IAC 17-1-10; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-11 Emergency care plans

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 11. A certified direct entry midwife shall develop a written emergency care plan that is as follows:
(1) Specific to each client.
(2) Signed by the client and certified direct entry midwife.
(3) Maintained in the client's medical record.
(4) Specifies the planned location of delivery.
(5) Designates a hospital or hospitals, including directions to the hospital or hospitals from the planned location of delivery, where the client can receive emergency care.
(6) Includes the:
(A) name;
(B) address; and
(C) telephone number;
of the collaborating physician, certified direct entry midwife, the infant's physician, and any other designated practitioner.
(7) Includes the:
(A) name;
(B) address; and
(C) telephone number;
of an emergency contact or contacts for the client.
(8) Includes a signed release of the client's medical records in accordance with IC 25-23.4-4-1(a)(5).
(9) Filed with the designated hospital or hospitals listed in the emergency care plan.
(Medical Licensing Board of Indiana; 844 IAC 17-1-11; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)


844 IAC 17-1-12 Standards of competent practice

Authority: IC 25-22.5-2-7; IC 25-23.4-2-6

Sec. 12. (a) In the conduct of the practice of midwifery, a certified direct entry midwife shall abide by and comply with the standards of competent practice in this rule.

(b) A certified direct entry midwife shall only practice in nonhospital settings.

(c) A certified direct entry midwife shall exercise reasonable care and diligence in the certified direct entry midwife's practice of midwifery based upon generally accepted scientific principles, methods, and current professional theory and practice.

(d) The North American Registry of Midwives, Midwives Alliance of North America, Indiana Midwives Association, and National Association of Certified Professional Midwives' guidelines shall be considered as authoritative sources of such current professional theory or practice.

(e) A certified direct entry midwife shall provide an informed disclosure of practice form, pursuant to IC 25-23.4-4-3, to the potential client, specifically including the monetary amount covered by the liability insurance policy held by the certified direct entry midwife.
(Medical Licensing Board of Indiana; 844 IAC 17-1-12; filed Apr 20, 2017, 9:26 a.m.: 20170517-IR-844150448FRA)

LSA Document #15-448(F)
Notice of Intent: 20151223-IR-844150448NIA
One Year Requirement (IC 4-22-2-25): 20160831-IR-844150448ARA
Proposed Rule: 20170104-IR-844150448PRA
Hearing Held: February 23, 2017
Approved by Attorney General: April 5, 2017
Approved by Governor: April 18, 2017
Filed with Publisher: April 20, 2017, 9:26 a.m.
Documents Incorporated by Reference: None Received by Publisher
Small Business Regulatory Coordinator: Darren R. Covington, J.D., Indiana Professional Licensing Agency, Indiana Government Center South, 402 West Washington Street, Room W072, Indianapolis, IN 46204, (317) 234-2011, dcovington@pla.in.gov

Posted: 05/17/2017 by Legislative Services Agency

DIN: 20170517-IR-844150448FRA
Composed: May 03,2024 8:13:22PM EDT
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