DEPARTMENT OF HEALTH AND SOCIAL SERVICES
ORDER
NATURE OF THE PROCEEDINGS:
The Department of Health and Social Services (“DHSS”) initiated proceedings to adopt Rules and Regulations Governing the Practice of Non-Nurse Midwifery. The DHSS proceedings to adopt regulations were initiated pursuant to 29 Delaware Code Chapter 101 and authority as prescribed by 16 Delaware Code, Chapter 1, Section 122(3) h.
On November 1, 2001 (Volume 5, Issue 5), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by December 3, 2001, or be presented at a public hearing on November 28, 2001, after which time DHSS would review information, factual evidence and public comment to the said proposed regulations.
Verbal and written comments were received and evaluated. The results of that evaluation are summarized in the accompanying “Summary of Evidence.”
SUMMARY OF EVIDENCE
A public hearing was held on November 28, 2001 at 3:00 p.m. in room 400-B of the Delaware Technical and Community, Terry Campus, Route 13 and Denneys Road, Dover, Delaware 19901, before David P. Walton, Hearing Officer, to discuss the proposed Department of Health and Social Services (DHSS) Rules and Regulations Pertaining to the Practice of Non-Nurse Midwifery. The announcement regarding the public hearing was advertised in the Delaware State News, the News Journal and the Delaware Register of Regulations in accordance with Delaware Law. Ms. Prue Albright from the Community Health Care Access (CHCA) Section, Division of Public Health (DPH), made the agency’s presentation. Attendees were allowed and encouraged to discuss and ask questions regarding all sections of the proposed regulations. Public testimony was given at the public hearing and written comments were also received during the comment period. Groups represented that offered comments included:
Home Birth Mothers and Fathers
State Representative Pamela Maier (Debbie Puzzo)
Christiana Care, Director Internal Fetal Medicine
Certified Nurse Midwives (CNM)
Certified Professional Midwives (CPM)
Midwives Alliance of North America (MANA)
Certified Midwives (CM)
Registered Nurses (RN)
Physicians (DO, MD & OB/GYN)
Emergency Medical Technician (EMT)
Advanced Practice Nurse (APN) Council,
Delaware Nurse Association
Medical Society of Delaware
Delaware's American College of Emergency Physicians
American College of Nurse-Midwives
Citizens for Midwifery, Inc.
Midwifery Task Force (National midwifery
advocacy organization)
American College of Obstetricians and Gynecologists
(Delaware Section)
Women’s Care Associates of Dover, P.A.
Delaware Perinatal Board
Standards Committee, Delaware Perinatal Board
Delaware Friends of Midwives
North American Registry of Midwives (NARM)
All public comments and the DHSS (Agency) responses are as follows:
• Regulation Section III & IV There was a suggestion to change the physician Collaborative Agreement part of the regulation from physician to a Delaware licensed Obstetrician/Gynecologist or physician with obstetrical hospital privileges.
Agency Response: While considering this comment it was determined that the agency had fully intended the collaborative agreement to be with a Delaware licensed physician with obstetrical hospital privileges. In the final version, the regulation was amended to reflect this requirement.
• Regulation Section III & IV Concern was voiced that the physician Collaborative Agreement sections of the regulation are too restrictive and that non-nurse midwives should not be required by regulation to have such an agreement. The agreement should be between the patient (expectant mother) and the physician.
Agency Response: While the agency acknowledges childbirth as a natural biological process, obstetrical emergencies do arise and are most successfully dealt with, with a well thought out plan of action. The agency believes this plan should be developed a head of time through a collaborative agreement between the non-nurse midwife and physician. The agency also agrees that having a physician collaborative agreement is restrictive, but is a necessary step in ultimately providing the best possible medical interventions available to protect and preserve the health of mother and newborn.
• Regulation III & IV A suggestion was voiced that the Collaborative Agreement be amended to ensure the planned birth site is within 30 minutes of the hospital where the back-up physician has hospital privileges.
Agency Response: While this sort of requirement would add a degree of timeliness to an emergency event, it also may unnecessarily infringe on a home birth mother’s choice to deliver at home. Rather than a cover-all regulatory requirement, the agency thinks this sort of requirement should be based on individual pregnancy risk factors or on a case-by-case basis. During the pregnancy, the physician, non-nurse midwife and expectant mother are in the best position to decide on distance and time limitations to the hospital. Making the time/distance to hospital decision on an individual basis also recognizes the fact that the birth of a baby is a natural, biological event, which can happen safely with very little medical intervention.
• Regulation Section IV Concern was expressed about this section of the regulation requiring non-nurse midwives to have personal medical malpractice insurance. Delaware physicians and nurses are not required by law to carry personal medical malpractice insurance.
Agency Response: Research through the Board of Medical Practice and Board of Nursing revealed that there is no statutory or regulatory mandate requiring physicians or nurses to have personal medical malpractice insurance. It is highly recommended for both of these groups. As a result, the regulatory requirement for non-nurse midwives to have personal medical malpractice insurance will be deleted from the regulation.
• A general concern was expressed that it was premature to promulgate regulations while legislation (HB 299) is being considered in the General Assembly.
Agency Response: While on the surface this appears to be a valid concern, these regulations should have actually been updated right after the nurse midwives were removed from under the authority of the Department and placed under the Board of Nursing in January 2000.
• Concerns were expressed that some language in the regulation would grant medication prescriptive authority to non-nurse midwives and that the term midwife was not clearly defined in the regulation.
Agency Response: Research of the regulation revealed that medication prescriptive authority is actually specifically addressed in the physician/non-nurse midwife Collaborative Agreement (Section IV). The regulation requires the physician to maintain prescriptive authority and outline guidelines and protocols to access medications. To further define midwife, the definition of Nationally Certified Midwife was added to the Definitions section (Section III) of the regulation and the terms Nationally Certified Midwife were subsequently added to the Qualifications section (Section IV) of the regulation. Additionally, the definition of Direct entry/non-nurse midwife was further refined for clarity purposes.
• A suggestion was offered that the regulation be amended to license the Certified Midwife for home, birth center or hospital births.
Agency Response: To permit non-nurse midwives to practice at specific locations is beyond the authority of the Department. The back-up physician, as well as birth centers and hospitals need to be part of the decision for a non-nurse midwife to practice in said facilities.
In addition to changes recommended in this Summary of Evidence, minor grammatical corrections were made to the draft regulations.
The public comment period was open from November 1, 2001 to December 3, 2001.
Verifying documents are attached to the Hearing Officer’s record. The regulation has been approved by the Delaware Attorney General’s office and the Cabinet Secretary of DHSS.
FINDINGS OF FACT:
The Department finds that the proposed regulations, as set forth in the attached copy should be adopted in the best interest of the general public of the State of Delaware.
The proposed regulations include modifications from those published in the November 1, 2001, Register of Regulations, based on comments received during the public notice period. These modifications are deemed not to be substantive in nature.
THEREFORE, IT IS ORDERED, that the proposed Rules And Regulations Governing The Practice of Non-Nurse Midwifery are adopted and shall become effective April 10, 2002, after publication of the final regulation in the Delaware Register of Regulations.
VINCENT P. MECONI
SECRETARY
Delaware State Board Of Health
Rules And Regulations Pertaining To The
Practice Of Midwifery
Adopted by the State Board of Health on April 17, 1978, amended September 19, 1978, and December 22, 1982, and amended to be effective 5/15/85.
Under the authority granted to the State Board of Health under 16 Del. C. §122 (3) (h), the Board of Health of the State of Delaware hereby adopts the following regulations pertaining to the practice of midwifery in the State of Delaware.
Section I - Definitions
a. Midwifery is the management of the woman throughout an essentially uncomplicated maternity cycle and includes the immediate care of the newborn. Management may include but is not limited to the following acts: physical examination during the maternity cycle; history taking; prenatal, postpartum and family planning education and counseling; preparation for childbirth; physical and emotional monitoring during labor and delivery including diagnostic tests; attending spontaneous vaginal births; routine inspection of the vagina and cervix throughout the maternity cycle; providing local anesthesia for perineal repair; performing and repairing episiotomies; resuscitating the newborn according to accepted procedures; documenting activities in appropriate maternity records; signing Birth Certificates: Provided, however, that these regulations shall not apply to a person assisting a licensed physician who may perform any of the above listed acts, or under emergency circumstances.
b. Essentially uncomplicated refers to periodic mutual determinations by the midwife and physician that the woman's physical and support needs can be met safely by a midwife.
c. Alliance is a relationship between a midwife and a physician(s) licensed to practice medicine or osteopathy in Delaware whereby medical consultation and referral, available on a 24-hour basis, is agreed upon in writing, signed by both parties, and filed with the State Board of Health.
Section II - Qualifications
No permit to practice midwifery in the State of Delaware shall be issued by the State Board of Health unless an applicant can demonstrate that said applicant has met the following qualifications:
a. Age of 21 years or older;
b. Licensed as a Registered Professional Nurse in the State of Delaware;
c. Possesses a valid certification by the American College of Nurse Midwives;
d. Submits a sworn statement that he/she has not been convicted of a felony; been professionally penalized or convicted of substance addiction; had a professional nursing license suspended or revoked in this or another state; been professionally penalized or convicted of fraud; is physically and mentally capable of engaging in the practice of midwifery; and
d. Has formed an alliance.
Section III - Application
Any person desiring to obtain a permit to practice midwifery shall make a written application to the Secretary of the State Board of Health. Such application shall be accompanied by the necessary documents setting forth the facts that the applicant possesses the qualifications in Section II. If after investigation of the application by the State Board of Health or its designee, it appears the applicant is qualified to practice midwifery, the State Board of Health shall issue a permit to practice midwifery in the State of Delaware.
Section IV - Maintenance of Permit
No person granted a permit under these regulations shall engage in active practice of midwifery without having an established alliance with a physician(s) licensed to practice medicine or osteopathy in the State of Delaware. Should the alliance be terminated during the permit period, the midwife must form a new alliance and submit the agreement to the State Board of Health before continuing to practice as a midwife. Failure to do so will result in automatic and immediate revocation of permit.
Loss of certification as a midwife from the American College of Nurse Midwives or suspension or revocation of the license to practice professional nursing in Delaware will result in automatic and immediate revocation of the permit to practice midwifery in Delaware.
Section V - Renewal of Permit
Any permit granted to practice midwifery in the State of Delaware shall terminate annually on December 31. The fee for such annual permit shall be $15.00. Said permit shall be renewable annually with the filing of an application and documentation setting forth continued qualification in items "b" through "e" of Section II. Should said permit not be renewed by January 31, the permit is considered lapsed and the midwife shall apply according to Section III.
Section VI - Exclusion
Any person who on September 19, 1978, held a valid permit issued by the State Board of Health to practice midwifery in the State of Delaware may be granted a permit to practice midwifery even though that person does not meet the qualifications specified in items "b" and "c" of Section II of these Rules and Regulations providing such midwife must continue to demonstrate to the State Board of Health full compliance with all other provisions of these Regulations and any special conditions as set forth by the State Board of Health to assure full compliance with all other provisions.
Section VII - Complaints
Any person may make a complaint in writing to the State Board of Health concerning incompetency, negligence, addiction to drugs and/or alcohol, physical or mental impairment, misrepresentation, willful breach of confidence, failure of a midwife to report a birth, or failure to otherwise comply with these regulations. Complaints shall be investigated by the State Board of Health or its designee and a determination made as to the need for a hearing. In the event a hearing is to be held, the midwife shall be notified by certified mail at least fifteen (15) days prior to the hearing as to the time and place of the hearing and any allegations which the Board intends to investigate. If such complaint is found to be justified, the permit of the midwife against whom the complaint has been lodged may, at the discretion of the State Board of Health, be revoked or suspended.
Section VIII - Illegal Practice
Any person who practices as a midwife as defined in item "a" of Section I in the State of Delaware without a permit issued by the State Board of Health shall be subject to a fine pursuant to 16 Del. C. § 107.
Section IX - Effective Date
These Regulations shall become effective January 14, 1983, and shall replace Rules and Regulations Pertaining to the Practice of Midwifery which were in effect until that date.
Section X - Severability
Should any section, sentence, clause, or phrase of these Rules and Regulations be legally declared unconstitutional or invalid for any reason, the remainder of said Rules and Regulations shall not be affected thereby.
Amendment To
Delaware State Board Of Health
Rules And Regulations Pertaining To The
Practice Of Midwifery
A waiver to the qualifications requirements may be approved by the State Board of Health to allow practice by a traditional midwife under the following circumstances and qualifications:
a. Evidence is submitted to the State Board of Health of a reasonable attempt to secure a licensed professional midwife.
b. An alliance has been formed with a physician licensed in Delaware and certified by the American Board of Obstetrics and Gynecology.
c. Evidence is submitted of acceptable training and experience as a midwife that meets criteria established by the Board.
d. Is at least 21 years of age.
e. Submits a sworn statement that he/she has not been convicted of a felony or charged with substance abuse, and is physically and mentally capable of engaging in such practice.
f. The area of practice shall be limited, by agreement with the allied physician, to a population which is medically underserved or has religious tenets opposed to medical practices.
g. Agrees to abide by all laws and regulations applicable to the care of newborn infants and registration of births.
If the above requirements are met, a limited license may be approved, to be renewed annually, and the license so designated.
Adopted by the State Board of Health to become effective May 15, 1985.
STATE OF DELAWARE
RULES AND REGULATIONS PERTAINING TO THE
PRACTICE OF NON-NURSE MIDWIFERY
These regulations replace regulations previously adopted on April 17, 1978; amended September 19, 1978, December 22, 1982, and May 15, 1985, by the Delaware State Board of Health. Effective Date: [Xxx xx, xxxx April 10, 2002].
Section I – Purpose
The purpose of these Regulations is to establish and define conditions under which individuals may be granted permits to practice direct entry/non-nurse midwifery in the State of Delaware. The Department of Health and Social Services, through the Division of Public Health, will recognize and issue a permit to practice midwifery for direct entry/non-nurse midwives.
Section II – Authority
Title 16, Delaware Code, Chapter 1, Section 122 (3) h.
Section III – Definitions
a. Midwifery practice: is the management of women’s health care, focusing particularly on pregnancy, childbirth, the postpartum period, care of the newborn, and the family planning and gynecological needs of women, including the prescription of appropriate medications and devices within this defined scope of practice. The midwife practices within a health care system that provides for consultation, collaborative management or referral as indicated by the health status of the client.
b. [Direct entry/non-nurse midwife: A person who has met the qualifications and received a permit from the Delaware Division of Public Health to practice midwifery in Delaware who is not licensed as an advanced practice nurse midwife. Direct entry /non-nurse midwife: A midwife that has entered the profession directly through midwifery education and training and not through a prerequisite program of nursing and has met the qualifications and received a permit from the Delaware Division of Public health to practice midwifery in DE.]
c. [Certified midwife: A person who has met the criteria stated in Section IVa (possesses a valid certification by national certification body). Nationally Certified Midwife: a direct entry midwife that has met national certification from North American Registry of Midwives (Certified Professional Midwife CPM ) or American College of Nurse Midwives (Certified Midwife)]
d. Collaborative Agreement: Written verification of health care facility approved clinical privileges; or health care facility approved job description; or a written document that outlines the process for consultation and referral between a direct entry/non-nurse midwife and a [physician. Delaware licensed physician with obstetrical hospital privileges.]
e. Guidelines/Protocols: Suggested pathways to be followed by direct entry/non-nurse midwives for managing a particular medical problem. These guidelines/protocols shall be developed collaboratively by the midwife and a [licensed physician. Delaware licensed physician with obstetrical hospital privileges.]
f. Referral: The process whereby a direct entry/non-nurse midwife directs the client to a physician or another health care professional for management of a particular problem or aspect of the client’s care.
Section IV - Qualifications
To receive a permit to practice direct entry/non-nurse midwifery in the State of Delaware, an applicant must submit documentation to the Division of Public Health that they meet the following qualifications:
a. [Possesses a valid certification by the American College of Nurse-Midwives Certification Council, Inc.; has completed a midwifery education program accredited by the ACNM’s Division of Accreditation; or has completed an equivalent program of studies as determined by the certification agency, including Certified Professional Midwives (CPM) and/or Certified Midwife (CM). Demonstration of completion of an accredited midwifery education program and is a Nationally Certified Midwife as demonstrated by possessing a valid certification of Certified Professional Midwives (CPM) from the North American Registry of Midwives or Certified Midwife (CM) from the American College of Nurse –Midwives Certification Council or an equivalent certification.]
b. Submits a sworn statement that he/she has not been convicted of a felony; been professionally penalized or convicted of substance addiction; had a professional midwifery license suspended or revoked in this or another state; been professionally penalized or convicted of fraud; and is physically and mentally capable of engaging in the practice of midwifery.
c. Establishes a collaborative agreement with a [medical provider Delaware licensed physician with obstetrical hospital privileges] which includes at a minimum:
• a minimum number of medical provider prenatal visits.
• guidelines and protocols that must include access and use of oxygen, medications (including Intravenous medications), emergency protocols for labor, delivery, and postpartum for both mother and neonate.
d. Possesses personal medical malpractice insurance.
[e d]. Submits to the Division of Public Health a sample contract between the midwife and the pregnant women outlining the scope of practice and potential risk factors and complications.
Section V – Application
Any person who wishes to obtain a permit to practice direct entry/non-nurse midwifery shall make a written application to the Division of Public Health. Such application shall be accompanied by the necessary documents demonstrating that the applicant possesses the qualifications in Section IV. If, after investigation of the application by the Division of Public Health, it appears the applicant is qualified to practice direct entry/non-nurse midwifery, a permit to practice midwifery in the State of Delaware will be issued.
Section VI – Maintenance of Permit
No person granted a permit under these regulations shall engage in active practice of direct entry/non-nurse midwifery without continuously meeting the qualifications in Section IV. Changes that occur during the permit period (one year) must be reported to the Division of Public Health.
Section VII – Renewal of Permit
Any permit granted to practice direct entry/non-nurse midwifery in the State of Delaware shall terminate annually on December 31. The fee for such annual permit shall be determined annually (in July) by the Division of Public Health and not be less than $15.00. Permits shall be renewable annually with the filing of an application and documentation setting forth continued qualifications as specified in Section IV. Should a permit not be renewed by January 31, the permit is considered lapsed and the direct entry/non-nurse midwife shall apply according to Section V.
Section VIII – Complaints
Any person may make a complaint in writing to the Division of Public Health concerning failure to comply with these regulations. The Division of Public Health will investigate complaints about direct entry/non-nurse midwives.
Section IX – Illegal Practice
Any person who practices as a direct entry/non-nurse midwife, as defined in Section III, in the State of Delaware without a permit issued by the Division of Public Health shall be subject to a fine pursuant to 16 Del. C 107.
Section X - Severability
Should any section, sentence, clause, or phase of these Rules and Regulations be legally declared unconstitutional or invalid for any reason, the remainder of these Rules and Regulations shall not be affected.