4 CCR 739-1
RULES AND REGULATIONS Adopted April 1, 2002 These rules are promulgated and adopted by the Director of Registrations pursuant to § 12-37-106(1)(a), C.R.S.
RULE 1 - STANDARDS FOR TRAINING BEFORE JULY 1, 2003 The purpose of this rule is to establish minimum training requirements to become registered as a direct- entry midwife before July 1, 2003 as required by § 12-37-103(5) & (6), C.R.S. Each applicant for registration shall submit proof of training that meets the following minimum criteria.
A. The apprenticeship or clinical practice shall be for a minimum of one calendar year.
B. The theoretical and tutorial content shall include, at a minimum:
1. Basic knowledge and skills in the following:
2. Antepartum care:
3. Intrapartal care:
4. Postpartal care:
5. Care of the Newborn
6. Legal issues:
C. Qualified individuals to verify the training of the applicant shall include:
1. A physician whose license is in good standing in the jurisdiction in which the training was conducted and who has at least 5 years experience in the care of mothers and infants during the prenatal through the postpartum period.
2. A nurse-midwife whose license is in good standing in the jurisdiction in which the training was conducted and who has at least 5 years experience in the care of mothers and infants during the prenatal through the postpartum period.
3. A direct-entry midwife whose authorization to practice was in good standing in the jurisdiction in which the training was conducted and who has been responsible as the primary birth attendant from the prenatal through the postpartum period of a minimum of 60 women. Birth experiences during the supervising midwife's apprenticeship or supervised clinical practice are not applicable.
RULE 2 - STANDARDS FOR EDUCATION ON OR AFTER JULY 1, 2003 The purpose of this rule is to establish minimum education requirements to become registered as a direct- entry midwife on or after July 1, 2003 as required by § 12-37-103(6), C.R.S.
A. To become registered in Colorado on or after July 1, 2003, instead of an apprenticeship, an applicant will have to have graduated from an accredited midwifery educational program approved by the Midwifery Education and Accreditation Council (“MEAC”).
B. An applicant may also become registered if such applicant has obtained a “substantially equivalent” education approved by the Director of Registrations. Substantially equivalent education can be achieved by one of the following methods:
1. An applicant who is credentialed as a Certified Professional Midwife (“CPM”) as established and administered by the North American Registry of Midwives (“NARM”) will automatically be deemed eligible for registration.
2. Completion and certification under NARM's entry-level Portfolio Evaluation Process (“PEP”). If the PEP determines that the applicant has obtained a substantially equivalent education as that required in Colorado, then such applicant will be eligible for registration. All expenses associated with PEP are the applicant's responsibility 3. Applicants can utilize one of the above methods in addition to having a credential review performed by the International Credentialing Associates (“ICA”) or International Consultants of Delaware (“ICD”). The Director will not accept a credentials evaluation from an organization not listed in this rule and all expenses associated with the review are borne by the applicant.
C. Failure to satisfy one of the three methods listed in this rule will result in the Director denying the application.
RULE 3 - EDUCATIONAL STANDARDS FOR THE ADMINISTRATION OF OXYGEN The purpose of this rule is to establish minimum training requirements for directentry midwives with respect to the safe administration of oxygen to patients pursuant to § 12-37-105(13), C.R.S.
A. Prior to administering oxygen, the direct-entry midwife shall submit to the Director proof of having completed education in the administration of oxygen to women in labor and infants. Such education shall include content and practice with the use of equipment to administer oxygen by nasal canula, mask and bag, and mask. The topics and areas to be included, at a minimum, are:
1. basic anatomy of the respiratory and circulatory system in adults and fetal/newborn differences;
2. indications for the use of oxygen (maternal and infant);
3. selection of method for oxygen administration for mother and infant;
4. determination of airway status;
5. clearing the infant airway by use of bulb and DeLee suctioning;
6. flow rate selection for mother or infant;
7. assessment of effectiveness of the oxygen administration to mother and infant;
8. indications for discontinuing the use of oxygen; and 9. setting up and maintaining the oxygen equipment, including changing tanks and regulators and cleaning and disinfecting bags and masks between patients.
B. In order to receive the Director's approval of the sufficiency of such training, the direct-entry midwife must submit proof that the instructor was qualified to present the class, including proof of appropriate education and a minimum of one year's experience with infants and mothers. RULE 4 - PRACTICE RESTRICTIONS The purpose of this rule is to define the practice restrictions applicable to a registered direct-entry midwife.
A. The registered direct-entry midwife shall not provide care to any woman whose medical history exhibits the following signs or symptoms:
1. diabetes mellitus or gestational diabetes;
2. hypertensive disease (blood pressure greater than 140/90 at rest);
3. pulmonary disease or cardiac disease which interferes with activities of daily living;
4. a history of thrombophlebitis or pulmonary embolism;
5. blood dyscrasia, for example sickle cell anemia;
6. seizures controlled by medication if the mother has seized within the last year;
7. Hepatitis B, HIV positive, or AIDS;
8. current use of psychotropic medications if woman is not under the care and monitoring of a physician during the pregnancy;
9. current substance abuse of drugs or alcohol;
10. Rh sensitization (positive antibody titre), an incompetent cervix, or previous uncontrollable postpartum hemorrhage;
11. The midwife shall not provide care to any woman who has had a previous cesarean section whose emergency plan does not include the ability to transport consistent with Rule 10 to a facility able to perform a cesarean section, and 12. infants who were premature, stillborn, or neonatal deaths associated with maternal health or genetic anomaly, unless there is a normal amniocentesis ruling out said anomaly, without an intervening normal pregnancy.
B. The registered direct-entry midwife shall not:
1. perform any operative or surgical procedures;
2. utilize any instruments or mechanical means of delivery, other than hemostats to clamp the cord;
3. perform versions; or 4. administer any medications except for eye prophylaxis of the newborn. RULE 5 - MINIMUM PRACTICE REQUIREMENTS REGARDING ANTEPARTUM CARE The purpose of this rule is to define and clarify generally accepted standards of safe care for women and infants regarding antepartum care.
A. The registered direct-entry midwife shall schedule patient visits at least once a month beginning in the first trimester through 28 weeks; every 2 weeks from 28 weeks through 35 weeks; and weekly from 36 weeks to delivery.
B. At the time of the initial visit for care, the registered direct-entry midwife shall, at a minimum:
1. obtain a medical, obstetrical, family and nutritional history;
2. determine the EDC and perform a baseline physical examination;
3. arrange to or obtain laboratory testing to include: blood group and Rh type, if unknown; Coombs test for all Rh negative mothers; CBC with differential; rubella titre; serology for syphilis; hepatitis B screen, urine for protein and glucose, culture if indicated; Gonococcal Culture screen and Chlamydia culture if needed based on social history, offer HIV testing;
4. discuss home birth, options to home birth, risk assessment, and referral procedures;
5. provide the client with the “Mandatory Disclosure” form and obtain informed consent on forms approved or provided by the Director; and 6. complete the emergency plan.
C. Care consistent with generally accepted standards of safe care for women and infants during each prenatal visit shall include, at a minimum, but not be limited to:
1. vital signs and weight;
2. urine dipstick for protein and glucose;
3. assessing for:
4. chart all findings, interventions, and outcomes including the quickening date;
5. provide teaching, guidance, and referral as appropriate; and 6. discuss the emergency plan and revise if needed.
D. Laboratory studies that are repeated during pregnancy include Indirect Coombs test at 28 and 36 weeks, if indicated; Hemoglobin and Hematocrit at 28 and 36 weeks; and a one-hour Glucose Tolerance Test with a minimum of a 50 Gram glucose loading dose shall be offered to the patient at 26-28 weeks.
E. At least one home visit shall be made during the third trimester to assure that environmental conditions are appropriate, supplies are procured, and birth participants are prepared for the home birth.
F. The registered direct-entry midwife shall refer mothers for evaluation by a qualified licensed health care provider and shall not continue as the care provider when a multiple gestation or a presentation other than vertex at the onset of labor are noted.
G. The registered direct-entry midwife shall refer mothers for evaluation by a qualified licensed health care provider and shall not continue as the primary care provider without the mother's consultation with a health care provider when the following conditions are noted until the mother has been assessed by the licensed health care provider and that provider has determined, based upon generally accepted medical standards, the pregnant woman is not exhibiting signs or symptoms of increased risk of medical or obstetrical or neonatal complications or problems during the completion of her pregnancy, labor, delivery or the post partum period, and is not exhibiting signs and symptoms of increased risk that her child may develop complications or problems during the first 6 weeks of life:
1. urine glucose of 2+ or greater on two sequential visits or if other signs or symptoms of gestational diabetes occur with the urine glucose;
2. hyperemesis beyond the 24th week of gestation;
3. hypertension - blood pressure greater than 140/90 or an increase from the baseline of greater than 30 mm Hg in the systolic or 15 mm Hg in the diastolic pressure;
4. signs and symptoms of preeclampsia including but not limited to persistent edema, increased blood pressure or proteinuria, increased reflexes, persistent headaches, epigastric pain or, visual disturbances;
5. seizures;
6. vaginal bleeding after 20 weeks;
7. signs and symptoms of urinary infections or sexually transmitted disease;
8. oral temperature in excess of 101° F for more than 24 hours accompanied by other signs or symptoms of clinically significant infection, or, which does not resolve within 72 hours;
9. laboratory results indicating need for medical treatment, for example, a positive culture;
10. anemia not responding to over the counter iron therapy as measured by Hemoglobin below 11 grams or Hematocrit below 34% at term;
11. signs and symptoms of polyhydramnios or oligohydramnios;
12. suspected fetal demise - lack of fetal movement, inability to auscultate fetal heart tones;
13. decreased fetal movements;
14. gestation longer than 42 weeks;
15. rupture of membranes for longer than 12 hours without labor;
16. premature labor - less than 37 weeks gestation;
17. active herpes;
18. intrauterine growth retardation; or 19. suspected abnormality of pelvis;
H. The registered direct-entry midwife shall perform pervimetry by 36 weeks gestation. RULE 6 - MINIMUM PRACTICE REQUIREMENTS REGARDING INTRAPARTUM CARE The purpose of this rule is to define and clarify generally accepted standards of safe care for women and infants regarding intrapartum care.
A. The direct-entry midwife is responsible for making arrangements to be with the patient by the time active labor has been established as determined by contractions occurring every 5 minutes and lasting for 60 seconds or cervical dilation of 5 cm or more, once labor has been so established, the registered direct-entry midwife shall remain with the mother.
B. When membranes rupture, the registered direct-entry midwife shall perform a sterile vaginal exam for prolapsed cord if the presenting part is not engaged and record fetal heart tones. In the case of premature rupture of the membranes, no further vaginal checks shall be made.
C. Aseptic technique and universal precautions will be used while rendering care.
D. The registered direct-entry midwife is responsible for monitoring the status of the mother and baby during labor and delivery including:
1. maternal vital signs and physical well being such as:
2. fetal vital signs and well being such as:
3. progress of labor including cervical effacement and dilation, station, presenting part and position;
4. coaching the birthing family;
5. obtaining a cord blood specimen, if feasible, which shall accompany the infant in case of transport;
6. checking the placenta and blood vessels and estimating blood loss;
7. checking the perineum and vaginal vault for tears; and 8. checking the cervix for tears and, if present, making appropriate referral.
E. The registered direct-entry midwife shall arrange for immediate consultation and transport according to the emergency plan if the following conditions exist:
1. bleeding other than capillary bleeding (“show”) prior to delivery;
2. signs of placental abruption including continuous lower abdominal pain and tenderness;
3. prolapse of the cord;
4. any meconium staining without reassuring fetal heart tones, moderate or greater meconium staining regardless of status of fetal heart tones;
5. significant change in maternal vital signs such as;
6. failure to progress in labor such as:
7. fetal heart rate below 120 or above 160 between contractions;
8. protein or glucose in the urine;
9. seizures;
10. atonic uterus;
11. retained placental fragments;
12. vaginal or cervical lacerations requiring repair; or 13. client requests transport.
RULE 7 - MINIMUM PRACTICE REQUIREMENTS REGARDING POSTPARTUM CARE The purpose of this rule is to define and clarify generally accepted standards of safe care for women and infants regarding postpartum care.
A. The direct-entry midwife shall remain with the mother and infant for a minimum of two hours after the birth or until the mother and infant are stable, whichever is longer.
B. The direct-entry midwife shall make a follow up visit within 72 hours to assess the progress of the mother and infant. Such visit shall include an assessment of, at a minimum, fundus, lochia, perineum, breasts, nutrition, hydration, elimination, emotional adjustment and bonding.
C. The direct-entry midwife shall instruct the mother and family in self care until the follow up visit is done.
D. The direct-entry midwife shall refer all Rh negative mothers for Rhogam within 72 hours of the birth.
E. The direct-entry midwife shall arrange for consultation and/or transport when:
1. There is maternal blood loss of more than 500 cc;
2. The mother has a fever of greater than 101°;F on any of the second through 10th days postpartum;
3. The mother cannot void within 6 hours after birth;
4. The lochia is excessive, foul smelling, or otherwise abnormal; or 5. There are signs of clinically significant depression (not the “baby blues”). RULE 8 - MINIMUM PRACTICE REQUIREMENTS REGARDING NEWBORN CARE The purpose of this rule is to define and clarify generally accepted standards of safe care for women and infants regarding newborn care.
A. The direct-entry midwife will perform the following care for the newborn:
1. Apgar scores at one minute and five minutes after birth and at 10 minutes if the 5 minute score is below 7;
2. a physical assessment including assessing presence of femoral pulses.
3. eye prophylaxis within 1 hour after birth as provided by 25-4-303, C.R.S.;
4. weigh the infant, measure height and head circumference, and check for normal reflexes;
5. perform a gestational age assessment; and 6. arrange to or obtain laboratory testing on the infant of an Rh negative mother to include blood type and Coombs test.
B. The direct-entry midwife shall arrange for or obtain the required newborn screenings required by § 25- 4-1004, C.R.S.
C. The direct-entry midwife shall recommend that the mother arrange for the administration of Vitamin K by a licensed health care provider birth within 72 hours.
D. The direct-entry midwife shall arrange for immediate transport for the infant who exhibits the following signs:
1. Apgar of 7 or less at ten minutes;
2. respiratory distress exhibited by respirations greater than 60 per minute, grunting, retractions, nasal flaring at one hour of age that is not showing consistent improvement;
3. inability to maintain body temperature;
4. medically significant anomaly;
5. seizures;
6. fontanel full and bulging;
7. suspected birth injuries;
8. cardiac irregularities;
9. pale, cyanotic, gray newborn; or 10. lethargy or poor muscle tone.
E. The direct-entry midwife will arrange for consultation and transport for an infant who exhibits the following:
1. signs of hypoglycemia including jitteriness;
2. abnormal cry;
3. passes no urine in 12 hours or meconium in 24 hours;
4. projectile vomiting;
5. inability to suck;
6. pulse greater than 180 or less than 80 at rest;
7. jaundice within 24 hours of birth; or 8. positive Coombs test.
F. Follow-up visits shall include assessment of the infant to include umbilical cord, temperature, pulse, respirations, weight, skin color and hydration status, feeding and elimination, sleep/wake patterns, and bonding.
RULE 9 - MINIMUM PRACTICE REQUIREMENTS REGARDING RECORD KEEPING The purpose of this rule is to define and clarify generally accepted standards of safe care for women and infants regarding record keeping.
A. The direct-entry midwife shall keep appropriate records on all patients. All records shall, at a minimum:
1. be accurate, current, and comprehensive, giving information concerning the condition and care of the client and associated observations;
2. provide a record of any problems that arise and the actions taken in response to them;
3. provide evidence of care required, interventions by professional practitioners and patient responses;
4. include a record of any factors (physical, psychological or social) that appear to affect the patient;
5. record the chronology of events and the reasons behind decisions made;
6. provide baseline data against which improvement or deterioration may be judged;
7. have a signature and date for each entry; and 8. all records shall be made available to the receiving health care provider in the event of transfer of care or the transport of mother or newborn.
B. The patient records shall include, at a minimum:
1. risk assessment;
2. mandatory disclosure form;
3. informed consent form and emergency plan;
4. assessments, interventions and recommendations for each prenatal visit;
5. progress of labor and maternal assessments during labor;
6. fetal assessments during labor;
7. Apgar scores and newborn examination;
8. administration of eye prophylaxis;
9. refusal of care by the mother;
10. filing the birth certificate as required by § 25-2-112, C.R.S.;
11. follow-up postpartum visits;
12. statement of verification that one copy of the record was provided to the mother or the health care provider of her choice; and 13. baseline blood pressure determined prior to the end of the second trimester or upon the initial visit if such visit occurs subsequent to the second trimester. RULE 10 -EMERGENCY PLAN The purpose of this rule is to establish the following emergency plan parameters pursuant to § 12-37- 105(6), C.R.S.:
The time required for transportation to the nearest facility capable of providing appropriate treatment shall not exceed 30 minutes unless the emergency plan prepared by the direct-entry midwife and the client, on the form prescribed by the Director, includes an estimate of time for transportation for appropriate treatment for the conditions listed above in Rules 5G, 6E, 7E, 8D, and 8E, and such plan is consented to by both the patient and the direct-entry midwife. A copy of such plan shall be given to the client. RULE 11 - DECLARATORY ORDERS The purpose of this rule is to establish procedures for the handling of requests for declaratory orders filed pursuant to the Colorado Administrative Procedures Act at § 24-4-105(11), C.R.S.
A. Any person registered pursuant to Article 37, Title 12, C.R.S., may petition the Director of Registrations (“Director”) for a declaratory order to terminate controversies or remove uncertainties as to the applicability of any statutory provision or of any rule or order of the Director.
B. The Director will determine, in his/her discretion and without notice to petitioner, whether to rule upon such petition. If the Director determines that s/he will not rule upon such a petition, the Director shall promptly notify the petitioner of his/her action and state the reasons for such decision.
C. In determining whether to rule upon a petition filed pursuant to this rule, the Director will consider the following matters, among others:
1. Whether a ruling on the petition will terminate a controversy or remove uncertainties as to the applicability to petitioner of any statutory provisions or rule or order of the Director.
2. Whether the petition involves any subject, question or issue that is the subject of a formal or informal matter or investigation currently pending before the Director or a court involving one or more petitioners.
3. Whether the petition involves any subject, question or issue which is the subject of a formal or informal matter or investigation currently pending before the Director or a court but not involving any petitioner.
4. Whether the petition seeks a ruling on a moot or hypothetical question or will result in an advisory ruling or opinion.
5. Whether the petitioner has some other adequate legal remedy, other than an action for declaratory relief pursuant to CRCP 57, that will terminate the controversy or remove any uncertainty as to the applicability to the petitioner of the statute, rule, or order in question.
D. Any petition filed pursuant to this rule shall set forth the following:
1. The name and address of the petitioner and whether the petitioner is registered pursuant to Article 5.5, Title 12, C.R.S.
2. The statute, rule, or order to which the petition relates.
3. A concise statement of all of the facts necessary to show the nature of the controversy or uncertainty and the manner in which the statute, rule, or order in question applies or potentially applies to the petitioner.
E. If the Director determines that s/he will rule on the petition, the following procedures shall apply:
1. The Director may rule upon the petition based solely upon the facts presented in the petition. In such a case:
2. If the Director rules upon the petition without a hearing, s/he shall promptly notify the petitioner of his/her decision.
3. The Director may, at his/her discretion, set the petition for hearing, upon due notice to petitioner, for the purpose of obtaining additional facts or information or to determine the truth of any facts set forth in the petition or to hear oral argument on the petition. The hearing notice to the petitioner shall set forth, to the extent known, the factual or other matters that the Director intends to inquire. For the purpose of such a hearing, to the extent necessary, the petitioner shall have the burden of proving all of the facts stated in the petition, all of the facts necessary to show the nature of the controversy or uncertainty and the manner in which the statute, rule or order in question applies or potentially applies to the petitioner and any other facts the petitioner desires the Director to consider.
F. The parties to any proceeding pursuant to this rule shall be the Director and the petitioner. Any other person may seek leave of the Director to intervene in such a proceeding, and leave to intervene will be granted at the sole discretion of the Director. A petition to intervene shall set forth the same matters as are required by Paragraph D of this rule. Any reference to a “petitioner” in this rule also refers to any person who has been granted leave to intervene by the Director.
G. Any declaratory order or other order disposing of a petition pursuant to this rule shall constitute agency action subject to judicial review pursuant to § 24-4-106, C.R.S.