Karen R. Mcalmon, MD

Karen R. McAlmon, MD

23 North Hill Drive

Lynnfield, Ma 01940

781-756-2067

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October 28, 2016

Dear Sir or Madam:

I am a neonatologist who has been the Director of the Level IIB Special Care Nursery at Winchester Hospital and a member of the Division of Newborn Medicine at Boston Children’s Hospital for over 20 years. I am also a past president of the Massachusetts Chapter of the American Academy of Pediatrics and currently its representative to the Perinatal Advisory Committee. In addition, I was a participant in the revisions of the Perinatal Regulations that were promulgated in 2006. I tell you these things to give you my credentials, however, this testimony is submitted on my personal behalf and not for any of the entities previously mentioned.

GENERAL COMMENTS:

Thank you for these careful revisions to Hospital Licensure regulations. I would specifically like to address Maternal Newborn Services regulations—105 CMR 130.601 to 150 CMR 130.650

I respect the desire to remove overtly prescriptive language that could limit a hospital’s ability to develop new and innovative approaches to patient care as standards of practice evolve, however, I also recognize that guidance may be needed to define and establish minimum and consistent standards for practice. Would the department consider issuing guidelines to supplement these regulations treating them much like Bylaws which define the what and Policy and Procedures which define the how of governance? This would be especially important for hospitals considering development of new services where more specific guidance would be helpful and in fact required. Examples that could now be transformed to guidelines include language sections deleted in 130.615, 130.616, 130.619, 130.621-130.624, 130.630, and 130.640. As guidelines, they would be much easier to change as new practices and standards are developed.

These regulations become somewhat confusing when the levels of care are addressed. I know the goal is to simplify and to make each level inclusive of the previous level, but there does not appear to be consistency in the detail addressed in each section where some have duplications and some do not mention topics so that it is unclear if they were intentionally deleted or not. I found the Level III section particularly confusing and would request that 130.630-130.650 be reviewed again for consistency and ease of understanding.

SPECIFIC COMMENTS

130.605 B

Is there no longer the requirement for site visits for approval of any new application?

130.610 Establishment of the Statewide Perinatal Advisory Committee

I request that the following be added. “The Department shall strive to have adequate representation from all appropriate disciplines, levels of care, constituency groups and geographic areas.”

130.616 Administration and Staffing

(A) Perinatal Committee

I believe more guidance is needed as currently not all hospitals adhere to the details of the regulations. Please consider addition of the following language: This committee should include representation from physician and nurse leaders from both the maternal and newborn services and representatives from other services as appropriate and should meet on a regular basis.

(B) Written Collaboration and Transfer Agreements

The latter part of this statement is not clear and somewhat confusing. (1) Each hospital with a maternal and newborn service that is not designated as a Level III service shall develop a written collaboration/transfer agreement with at least one primary Level III maternal and newborn service. The agreement shall include provisions for consultation; guidelines for maternal and newborn transfer, including provision of relevant medical information and ongoing patient-centered communications before, during and after transport or retro-transfer; and provision for professional educational offerings; and take into consideration unusual circumstances, such as lack of available bed or patient request. May I suggest the following to replace the blue bold wording at the end of the sentence that I believe would have the same intent: “assistance with management under unusual circumstances such as lack of bed availability”. I would also suggest that it would flow better if placed after the word retro-transfer and before provision for professional educational offerings.

(B) (5). I am concerned with the removal of the requirement for retrotransfer. There clearly needs to be and there are requirements for transfer to a higher level of care. There should also be for retrotransfer to a lower level of care, when appropriate. One of the things that distinguishs Massachusetts is its collaboration between levels of care with placing mother and newborn in the right place for the right care at the right time. The Level IB and Level IIA and IIB units have a definite role in the community for caring for and preparing infants for discharge to home. Level III hospitals should be encouraged to return maternal and neonatal patients to the transferring hospital when it is clinically appropriate.

130.616 (C) Administrative Policies

The added language is not clear and these populations (previously discharged, retrotransferred and antenatal patients) are distinct.

Besides 1. I would suggest adding the following:

2. Criteria for management of high risk mothers and newborns including guidelines for transfer to a higher level of care

3. Criteria for readmission of previously discharged infants

4. Criteria for re-admission of transferred infants and mothers

(2) The maternal and newborn service shall be self-contained and discrete from other hospital services and be situated so as to accommodate patient flow without passing through other functional areas of the hospital. There shall be limited access to the service.

I would suggest that it be moved to 130.618 Environment

(D) Patient Care Policies

It appears to me that too much has been removed and there needs to be more distinction between issues of care of the mother vs care of the newborn. I would suggest:

1) Care of the mother. Each maternal and newborn service shall develop and implement written patient care policies and procedures, supported by evidence based resources, which include, but are not limited to:

1. Criteria for induction and C/S delivery

2. Management of Labor including fetal monitoring

3. Pain management

4. Postpartum management of mothers and newborns

5. Lactation support

2) Care of the Newborn. Each maternal and newborn service shall develop and implement written patient care policies and procedures, supported by evidence based resources, which include, but are not limited to Such policies shall provide for the following:

1. Requirements for pediatrician/neonatologist presence at delivery

2. Apgar scores, etc.

3. In f delete At a minimum, the policy shall address: and all the further bullets. These are more guidelines than regulations.

For (l) Hearing screening through Universal Newborn Screening Program

(viii) Screening Protocols ADD

d. Prior to implementing a significant change in a hearing screen protocol approved by the Department, a hospital or birth center must request and have received written approval of the change from the Department.

I believe policies regarding discharge are important to keep and would reinstate the previously deleted 13. (13) Planning for discharge, including documentation of follow-up care arrangements and referral to appropriate community services and providers for both mother and infant.

160.616 (F) Nurse Staffing

The nurse is the first health care worker to examine a newborn and determine if there are issues of concern. Since the physician may not exam a newborn until 24 hours after birth (as noted in earlier regulation), there must be the requirement of an assessment by a health care worker and notification of any problems or abnormalities so that a physician can intervene as appropriate in a timely manner. I recommend that (4) which was deleted be reinstated. (4) A registered nurse shall complete an initial newborn nursing assessment and shall be responsible for notifying the physician of any abnormalities or problems.

130.624: Nursery

I wholeheartly agree with removal of large space requirements from Well Newborn Nursery, especially in light of current practice of rooming in and integrated care for the mother baby dyad on the postpartum unit. However, there are times when a baby should be in the Well Newborn Nursery—if closer monitoring is needed, mother is ill and not able to care for the newborn, newborn needs to stay in the hospital longer than mother for phototherapy—and in these cases there should be some guidance about space. I do not know the answer about how much; this would require further investigation. In addition, if babies are rooming in, there should be guidance regarding the availability of appropriate equipment in postpartum rooms/LDRPs to care for babies if acute stabilization/resuscitation is needed.

160.624 Nursery

Gowning is not required except for infants on precautions and then gowns are available at the bedside. The requirement for a gowning area should be removed.

(ED) Well-newborn nurseries shall ensure restricted, secure access. Special care nurseries shall be arranged so that entrance is gained solely through a well-lighted anteroom with provision for a handwashing and gowning area.

130.626 Infection Control

Standard precautions is equal to universal precautions. Other precautions may be required based on the presence of infection or colonization as outlined by CDC. The word standard should be removed. The vaccination should be that required by health care professionals. (A) Each maternal and newborn unit shall develop and implementhave policies incorporating standard precautions as defined in guidelines issued by the Centers for Disease Control and Prevention, and addressing, at a minimum, the ability for mothers and infants to be placed in isolation together and required vaccination of health care professionals.

Infection control issues are so important that I believe the policies and procedures for cleaning and disinfecting should be maintained in this area. I would not delete: Policies and procedures for cleaning, disinfecting or sterilization of patient care areas, equipment, supplies and infant linen shall be established, approved and periodically reviewed by the hospital’s infection control officer or equivalent.

160.627 Records

A. Maternal Record

(10) Not all infants have blood types checked. Can only be included in mother’s record if it was done. Add, if appropriate to this requirement. Infant’s condition at birth including gestational age, weight, Apgar score, blood type (if appropriate), and results of initial physical assessment.

B. Newborn Record

(3) Details need to be more comprehensive including Group B Strep results. Maternal antibodies is sufficient; Coombs is not from maternal studies. I would amend as follows: Maternal antenatal blood serology, blood typetyping, Rh factors, rubella antibody titer, coombs test for maternal antibodies if indicated, and prenatal HBsAg test and Group B strep culture results. In addition, results of maternal HIV testing, if applicable.

(8) The complete description of labor is not needed, but any complications should be noted. I would amend as follows: DComplete description of progress of labor including complications, diagnostic tests, treatment rendered and reasons for induction or operative procedures, if applicable.

(11) Time of sustained respirations is not required. I would amend as follows: Condition of the infant at birth including Apgar score, resuscitation required, time of sustained respirations, description of congenital anomalies, gestational age, head circumference, length, weight, pathological conditions and treatments.

(15) A nurse practitioner of physician’s assistant could do the initial medical exam. Should remove physician designee and replace with designee. I would amend as follows: Report of infant’s initial medical examination within 24 hours of birth, signed by the infant’s attending physician or his/ or her physician designee.

130.628: Data Collection and Reporting Systems

Standardization of quality metrics with validated measures and comparisons are vital for the ability to improve care across the state. The Vermont Oxford Network (VON) requires reporting that is valuable to the state and removes the need for the state to build systems to obtain, validate and review these metrics. All Level III units (except the freestanding children’s hospital) are currently members of VON. Some joined because of this regulatory requirement that was promulgated in 2006. There has been benefit with all Level III units using the same quality system, both to the individual units and to the state. This requirement should not be removed. I recommend reinstating: (E) Each hospital with a Level III maternal and newborn service shall develop and maintain quality improvement initiatives, through participation in the Vermont Oxford Network’s Very Low Birth Weight (VLBW) Database, and shall make Vermont Oxford Network data reports available to the Department upon request.

130.630: Level I – Community based Maternal and Newborn Service

(A) Collaboration/Transfer Agreements is a duplicate. It is already stated in 130.616.

(B) Administration and Staffing

There is no mention of the role of a nurse practitioner. She or he could clinically function in this environment.

I believe it is important to keep the information about emergency management and transfer of mothers and newborns and the need for on site physician presence. I recommend these be reinstated: (4) Emergency management of maternal patients, including the capacity to resuscitate and stabilize the patient prior to transfer. In the event of the need for emergency resuscitation and/or stabilization of the mother, an obstetrician shall be either onsite or called to come in to manage the emergency prior to transport of the mother to a Level II or Level III service.

(5) Emergency management of neonates, including the capacity to resuscitate and stabilize the patient prior to transfer. In the event of the need for emergency resuscitation and/or stabilization of the infant a pediatrician shall be either onsite or called to come in to manage the emergency prior to transport of the infant to a Level III service. All infants requiring ongoing mechanical ventilation shall be transferred to a Level III service.

(6) Arrangements for emergency transport to Level II and III services as stipulated in collaboration/transfer agreements. Infants shall be transferred to an appropriate service within geographic proximity except under unusual circumstances such as lack of available bed or by parental request.

(E) (1) Administration and Staffing

Should not refer to special care newborns as this can be confused with a special care nursery that is a Level II. Recommend removal of the words special care:

A physician certified by the American Board of Pediatrics with experience in the care of special care newborns shall be designated as the medical director of the Level IB Continuing Care Nursery Service.