PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of section 405.21 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 2505-a
Subject:
Perinatal Services.
Purpose:
To update the Breastfeeding Mother's Bill of Rights to conform with recommended standards of care.
Text of final rule:
Subdivision (f)(3) Section 405.21 is amended to read as follows:
(f)(3) Education and orientation of the mother who is planning to raise the baby.
(i) The hospital shall provide instruction and assistance to each maternity patient who has chosen to breastfeed and shall provide information on the advantages [and disadvantages] of breastfeeding and possible impacts of not breastfeeding to women who are undecided as to the feeding method for their infants. At a minimum:
(a) the hospital shall designate at least one person who is thoroughly trained in breastfeeding physiology and management to be responsible for ensuring the implementation of an effective breastfeeding program. At all times, there should be available at least one staff member qualified to assist and encourage mothers with breastfeeding;
(b) written policies and procedures shall be developed, updated, implemented, and disseminated annually to staff providing maternity or newborn care to assist and encourage the mother to breastfeed which shall include, but not be limited to:
(1) prohibition of the application of standing orders for anti-lactation drugs;
(2) placement of the newborn skin-to-skin for breastfeeding immediately following delivery, unless contraindicated;
(3) restriction of the newborn’s supplemental feedings to those indicated by the medical condition of the newborn or of the mother;
(4) provision for the newborn to be fed on demand;
(5) pacifiers or artificial nipples may be supplied by the hospital to breastfeeding infants to decrease pain during procedures, for specific medical reasons, or upon the specific request of the mother. Before providing a pacifier or artificial nipple that has been requested by the mother, the hospital shall educate the mother on the possible impacts to the success of breastfeeding and discuss alternative methods for soothing her infant, and document such education;
[provision for distribution of discharge packs of infant formula only upon a specific order by the attending practitioner or at the request of the mother;]
(6) prohibition of the distribution of marketing materials, samples or gift packs that include breast milk substitutes, bottles, nipples, pacifiers, or coupons for any such items to pregnant women, mothers or their families;
(7) prohibition of the use of educational materials that refer to proprietary product(s) or bear product logo(s), unless specific to the mother’s or infant’s needs or condition; and
(8) prohibition of the distribution of any materials that contain messages that promote or advertise infant food or drinks other than breast milk.
(c) the hospital shall provide an education program as soon after admission as possible which shall include but not be limited to:
(1) the importance of scheduling follow-up care with a pediatric care provider within the timeframe following discharge as directed by the discharging pediatric care provider;
(2) the nutritional and physiological aspects of human milk;
(3) the normal process for establishing lactation, including care of the breasts, common problems associated with breastfeeding and frequency of feeding;
(4) the potential impact of early use of pacifiers on the establishment of breastfeeding;
[(4)] (5) dietary requirements for breastfeeding;
[(5)] (6) diseases and medication or other substances which may have an effect on breastfeeding;
[(6)] (7) sanitary procedures to follow in collecting and storing human milk;
[(7)] (8) sources for advice and information available to the mother following discharge; and
(d) for mothers who have chosen formula feeding or for whom breastfeeding is medically contraindicated, hospitals shall provide individual training in formula preparation and feeding techniques.
Subdivision (f)(5) of Section 405.21 is amended to read as follows:
(f)(5) Discharge planning. The discharge of mother and newborn shall be performed in accordance with section 405.9 of this Part. In addition, prior to discharge, the hospital shall determine that:
(i) sources of nutrition for the infant and mother will be available and sufficient and if this is not confirmed, the attending practitioner and an appropriate social services agency shall be notified;
(ii) follow-up medical arrangements [for mother and infant], consistent with current perinatal guidelines and recommendations, have been made for mother and newborn;
(iii) the mother has been informed of community services, including the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), and shall make referrals to such community services as appropriate.
[(iii)] (iv) the mother has been instructed regarding normal postpartum events, care of breasts and perineum, care of the urinary bladder, amounts of activity allowed, diet, exercise, emotional response, family planning, resumption of coitus and signs of common complications;
[(iv)] (v) the mother has been advised on what to do if any complication or emergency arises;
[(v)] (vi) the newborn has had a documented and complete physical examination and verification of a passage of stool and urine;
[(vi)] (vii) the means of identification of mother and newborn are matched. If the newborn is discharged in the care of someone other than the mother, the hospital shall ensure that the person or persons are entitled to the custody of the newborn; and
[(vii)] (viii) the newborn is stable; sucking and swallowing abilities are normal. Routine medical evaluation of the neonate's status at two to three days of age shall have been conducted or arranged[as well as newborn]. Newborn screening shall be conducted at time of discharge, provided discharge is greater than 24 hours after the birth, or between the third and fifth day of life, whichever occurs first, in accordance with Part 69 of this Title.
Final rule as compared with last published rule:
Nonsubstantive changes were made in section 405.21(f)(3) and (i)(b)(7).
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.
Assessment of Public Comment
Public comments were submitted to the New York State Department of Health (DOH) in response to the proposed changes to Title 10 NYCRR section 405.21, requiring updates to the minimum standards for hospitals regarding perinatal services. The Department received comments from two health care organizations, one hospital, and one city health department. These comments and DOH’s responses are summarized below.
COMMENT: A comment suggested that the prohibition of the distribution of formula discharge packs should also pertain to obstetrical practices.
RESPONSE: These regulations, including the prohibition in the distribution of marketing materials, samples and gift bags to pregnant women, mothers and their families, apply to general hospitals, general hospital extension clinics and freestanding birthing centers providing perinatal services. Private obstetrical practices, however, are outside the Department’s legislated authority.
COMMENT: A comment suggested the elimination of “dietary requirements for breastfeeding,” or changing the word “requirements” to “suggestions” in section 405.21(f)(3)(i)(c)(5).
RESPONSE: In its Dietary Guidelines, the United States Department of Agriculture (USDA) states that: “When you are pregnant or breastfeeding, you have special nutritional needs.” See http://www.choosemyplate.gov/moms-breastfeeding-nutritional-needs. DOH believes that using the term “requirements” accomplishes the intent of the above guidance.
COMMENT: A comment suggested that information on the advantages of breastfeeding and possible impacts of not breastfeeding should be offered to all maternity patients, not just to those who are undecided.
RESPONSE: DOH encourages all women to be educated about the advantages of breastfeeding and possible impacts of not breastfeeding during prenatal care visits. However, the decisions of pregnant women who have been admitted to the hospital for delivery, and who have already decided to not breastfeed, should be respected.
COMMENT: A comment suggested that the regulations should specify that “skin-to-skin” placement applies in the case of both vaginal births and births by cesarean section, unless contraindicated.
RESPONSE: The regulations do not specify the method of delivery, but rather that all newborns should be placed skin-to-skin for breastfeeding immediately following delivery, unless contraindicated. DOH believes that the regulations provide sufficient clarity that skin-to-skin contract should occur after a birth by cesarean section.
COMMENT: A comment suggested that the Supplemental Nutrition Assistance Program (SNAP) be added to section 405.21(f)(5)(iii), in addition to the reference to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
RESPONSE: The regulations require mothers to be informed of community services. A specific reference to WIC is included because WIC targets pregnant and postpartum women, infants and children. Referrals to additional community services, including SNAP, are also encouraged. Furthermore, the WIC program is required to make referrals to SNAP, if an individual is eligible for SNAP but not enrolled.
