Section 640.42 Level II and Level II with Extended Neonatal Capabilities - Standards for Perinatal Care

Section 640

Section 640.42  Level II and

Level II with Extended Neonatal Capabilities − Standards for Perinatal

Care

To be designated as Level II or

Level II with Extended Neonatal Capabilities, a hospital shall apply to the

Department as described in Section 640.60 of this Part; shall comply with all

of the conditions described in Subpart O of the Hospital Licensing Requirements

that are applicable to the level of care necessary for the patients served; and

shall comply with the following provisions (specifics regarding standards of

care for both mothers and neonates as well as resource requirements to be

provided shall be defined in the hospital's letter of agreement with its APC):

a)         Level II and Level II with Extended Neonatal Capabilities −

General Provisions

A Level II or

Level II with Extended Neonatal Capabilities hospital shall:

1)         Provide all services outlined for Level I (Section 640.41(a));

2)         Provide diagnosis and treatment of selected high-risk

pregnancies and neonatal problems;

3)         Accept selected neonatal transports from Level I or other

Level II hospitals as identified in the letter of agreement with the APC; and

4)         Maintain a system for recording patient admissions,

discharges, birth weight, outcome, complications and transports to support

network CQI activities described in the hospital's letter of agreement with the

APC.  The hospital shall comply with the reporting requirements of the State

Perinatal Reporting System

el II hospitals as identified in the letter of agreement with the APC; and

4)         Maintain a system for recording patient admissions,

discharges, birth weight, outcome, complications and transports to support

network CQI activities described in the hospital's letter of agreement with the

APC.  The hospital shall comply with the reporting requirements of the State

Perinatal Reporting System.

b)         Level II  – Standards for Maternal Care

1)         The following maternal patients are considered to be

appropriate for management and delivery by the primary physician at Level II hospitals

without requirement for a maternal-fetal medicine consultation; however, the

hospital's letter of agreement shall establish the specific conditions for the

Level II hospital:

A)        Those listed for Level I (see Section 640.41(b));

B)        Normal current pregnancy although obstetric history may suggest

potential difficulties;

C)        Selected medical conditions controlled with medical treatment

such as, mild chronic hypertension, thyroid disease, illicit drug use, urinary

tract infection, and non-systemic steroid-dependent reactive airway disease;

D)        Selected obstetric complications that present after 32 weeks gestation,

such as,  mild pre-eclampsia/pregnancy induced hypertension, placenta previa,

abrupto placenta, premature rupture of membranes or premature labor;

E)        Other selected obstetric conditions that do not adversely

affect maternal health or fetal well-being, such as, normal twin gestation,

hyperemesis gravidium, suspected fetal macrosomia, or incompetent cervical os;

F)         Gestational diabetes, Class A1 (White's criteria).

2)         The attending health care provider shall consult a maternal-fetal

medicine subspecialist, as detailed in the letter of agreement with the APC and

outlined in the hospital's obstetric department policies and procedures, for

each of, but not limited to, the current pregnancy conditions listed in Section

640.Appendix H.Exhibit B

Gestational diabetes, Class A1 (White's criteria).

2)         The attending health care provider shall consult a maternal-fetal

medicine subspecialist, as detailed in the letter of agreement with the APC and

outlined in the hospital's obstetric department policies and procedures, for

each of, but not limited to, the current pregnancy conditions listed in Section

640.Appendix H.Exhibit B.  Subsequent patient management and site of delivery

shall be determined by mutual collaboration between the patient's physician and

the maternal-fetal medicine subspecialist.

3)         Hospitals

shall have the capability for continuous electronic maternal-fetal monitoring

for patients identified at risk, with staff available 24 hours a day, including

physician and nursing, who are knowledgeable of electronic maternal-fetal

monitoring use and interpretation. Physicians and nurses shall complete a

competence assessment in electronic maternal-fetal monitoring every two years.

c)         Level II – Standards for Neonatal Care

1)         The following neonatal patients are considered appropriate for

Level II hospitals without a requirement for neonatology consultation:

A)        Those listed for Level I (see Section 640.41(c));

B)        Premature infants at 32 or more weeks gestation who are

otherwise well;

C)        Infants with mild to moderate respiratory distress (not

requiring assisted ventilation in excess of six hours);

D)        Infants with suspected neonatal sepsis, hypoglycemia responsive

to glucose infusion, and asymptomatic neonates of diabetic mothers; and

E)        Infants with a birth weight greater than 1500 grams who are

otherwise well.

2)         The attending physician shall consult a neonatologist for the

following neonatal conditions

(not

requiring assisted ventilation in excess of six hours);

D)        Infants with suspected neonatal sepsis, hypoglycemia responsive

to glucose infusion, and asymptomatic neonates of diabetic mothers; and

E)        Infants with a birth weight greater than 1500 grams who are

otherwise well.

2)         The attending physician shall consult a neonatologist for the

following neonatal conditions.  Consultation shall be specified in the letter

of agreement with the APC and outlined in the hospital's pediatric department

policies and procedures for conditions including, but not limited to:

A)        Birth weight less than 1500 grams;

B)        10 minute Apgar scores of 5 or less;

C)        Handicapping conditions or developmental disabilities that

threaten subsequent development in an otherwise stable infant.

3)         Minimum conditions for transport shall be specified in the letter

of agreement and outlined in the hospital's pediatric department policies and

procedures for conditions including, but not limited to:

A)        Premature birth that is less than 32 weeks gestation;

B)        Birth weight less than 1500 grams;

C)        Assisted ventilation beyond the initial stabilization period of

six hours;

D)        Congenital heart disease associated with cyanosis, congestive

heart failure or impaired peripheral blood flow;

E)        Major congenital malformations requiring immediate

comprehensive  evaluation or neonatal surgery;

F)         Neonatal surgery requiring general anesthesia;

G)        Sepsis, unresponsive to therapy, associated with persistent

shock or other organ system failure;

H)        Uncontrolled seizures;

I)         Stupor, coma, hypoxic ischemic encephalopathy Stage II or

greater;

J)         Double-volume exchange transfusion;

K)        Metabolic derangement persisting after initial correction

therapy;

L)        Handicapping conditions that threaten life for which transfer

can improve outcome

rapy, associated with persistent

shock or other organ system failure;

H)        Uncontrolled seizures;

I)         Stupor, coma, hypoxic ischemic encephalopathy Stage II or

greater;

J)         Double-volume exchange transfusion;

K)        Metabolic derangement persisting after initial correction

therapy;

L)        Handicapping conditions that threaten life for which transfer

can improve outcome.

d)         Level II – Resource Requirements

Resources

shall include all those listed for Level I (Section 640.41(d)) as well as the

following:

1)         Experienced blood bank technicians shall be immediately

available in the hospital for blood banking procedures and identification of

irregular antibodies. Blood component therapy shall be readily available.

2)         Experienced radiology technicians shall be immediately

available in the hospital with professional interpretation available 24 hours a

day. Ultrasound capability shall be available 24 hours a day.  In addition,

Level I ultrasound and staff knowledgeable in its use and interpretation shall

be available 24 hours a day.

3)         Clinical laboratory services shall include microtechnique

blood gases in 15 minutes and electrolytes and coagulation studies within one hour.

4)         Personnel skilled in phlebotomy and intravenous (IV) placement

in the newborn shall be available 24 hours a day.

5)         Social work services provided by one social worker, with

relevant experience and responsibility for perinatal patients, shall be

available through the hospital social work department.

6)         Protocols for discharge planning, routine follow-up care, and

developmental follow-up shall be established.

7)         A respiratory care practitioner with experience in neonatal

care shall be available.

8)         One dietitian with experience in perinatal nutrition shall be

available to plan diets to meet the needs of mothers and infants

through the hospital social work department.

6)         Protocols for discharge planning, routine follow-up care, and

developmental follow-up shall be established.

7)         A respiratory care practitioner with experience in neonatal

care shall be available.

8)         One dietitian with experience in perinatal nutrition shall be

available to plan diets to meet the needs of mothers and infants.

9)         Capability to provide neonatal resuscitation in the delivery

room shall be satisfied by current completion of a nationally recognized neonatal

resuscitation program by medical, nursing and respiratory care staff or a

hospital rapid response team.

e)         Application for

Designation, Redesignation or Change in Network

1)         To be

designated or to retain designation, a hospital shall submit the required

application documents to the Department. For information needed to complete any

of the processes, see Section 640.50 and Section 640.60.

2)         The

following information shall be submitted to the Department to facilitate the

review of the hospital's application for designation or redesignation:

A)        Appendix A (fully

completed);

B)        Resource

Checklist (fully completed) (Appendices L, M, N and O);

C)        A

proposed letter of agreement between the hospital and the APC (unsigned); and

D)        The curriculum

vitae for all directors of patient care, i.e., obstetrics,  neonatal, ancillary

medical care and nursing (both obstetrics  and neonatal).

3)         When

the information described in subsection (e)(2) is submitted, the Department

will review the material for compliance with this Part. This documentation will

be the basis for a recommendation for approval or disapproval of the applicant

hospital's application for designation

nt care, i.e., obstetrics,  neonatal, ancillary

medical care and nursing (both obstetrics  and neonatal).

3)         When

the information described in subsection (e)(2) is submitted, the Department

will review the material for compliance with this Part. This documentation will

be the basis for a recommendation for approval or disapproval of the applicant

hospital's application for designation.

4)         The

medical co-directors of the APC (or their designees), the medical directors of

obstetrics and maternal and newborn care, and a representative of hospital

administration from the applicant hospital shall be present during the PAC's

review of the application for designation.

5)         The

Department will make the final decision and inform the hospital of the official

determination regarding designation. The Department's decision will be based

upon the recommendation of the PAC and the hospital's compliance with this Part

and may be appealed in accordance with Section 640.45. The Department will

consider the following criteria or standards to determine if a hospital is in

compliance with this Part:

A)        Maternity

and Neonatal Service Plan (Subpart O of the Hospital Licensing Requirements);

B)        Proposed

letter of agreement between the applicant hospital and its APC, in accordance

with Section 640.70;

C)        Appropriate

outcome information contained in Appendix A and the Resource Checklist;

D)        Other

documentation that substantiates a hospital's compliance with particular

provisions or standards of perinatal care set forth in this Part; and

E)        Recommendation

of Department program staff

agreement between the applicant hospital and its APC, in accordance

with Section 640.70;

C)        Appropriate

outcome information contained in Appendix A and the Resource Checklist;

D)        Other

documentation that substantiates a hospital's compliance with particular

provisions or standards of perinatal care set forth in this Part; and

E)        Recommendation

of Department program staff.

f)         Level II with Extended Neonatal Capabilities – Standards for Special

Care Nursery Services

1)         The following patients are considered appropriate for Level II

with Extended Neonatal Capabilities hospitals with SCN services:

A)        Those listed in subsection (c) of this Section;

B)        Infants with low birth weight greater than 1250 grams;

C)        Premature infants of 30 or more weeks gestation;

D)        Infants on assisted ventilation.

2)         For each of the following neonatal conditions, consultation

between the Level II with Extended Neonatal Capabilities attending physician

and the APC or Level III neonatologist is required. The attending neonatologist

at the Level II with Extended Neonatal Capabilities hospital and the attending

neonatologist at the APC or Level III hospital shall determine, by mutual collaboration,

the most appropriate hospital to continue patient care. The Level II hospital

with Extended Neonatal Capabilities shall develop a prospective plan for

patient care for those infants who remain at the hospital.  Both the letter of

agreement with the APC and the hospital's department of pediatrics' policies

and procedures shall identify conditions that might require transfer to a Level

III hospital, including, but not limited to::

A)        Premature birth that is less than 30 weeks gestation;

B)        Birth weight less than or equal to 1250 grams;

C)        Conditions listed in subsections (c)(3)(C) through (L) of this

Section

nt with the APC and the hospital's department of pediatrics' policies

and procedures shall identify conditions that might require transfer to a Level

III hospital, including, but not limited to::

A)        Premature birth that is less than 30 weeks gestation;

B)        Birth weight less than or equal to 1250 grams;

C)        Conditions listed in subsections (c)(3)(C) through (L) of this

Section.

g)         Level II with Extended Neonatal Capabilities – Resource

Requirements

1)         Resources shall include all those listed in Section 640.41(d)

for Level I care and in Section 640.42(d) for Level II care, as well as the

following:

A)        Obstetric activities shall be directed and supervised by a full-time

obstetrician certified by the American Board of Obstetrics and Gynecology or a

licensed osteopathic physician with equivalent training and experience and certification

by the American Osteopathic Board of Obstetrics and Gynecology.

B)        Neonatal activities shall be directed and supervised by a full-time

pediatrician certified by the American Board of Pediatrics Sub-Board of

Neonatal/Perinatal Medicine or a licensed osteopathic physician with equivalent

training and experience and certification by the American Osteopathic Board of

Pediatricians.

C)        The directors of obstetric and neonatal services shall ensure

the back-up supervision of their services when they are unavailable.

D)        The obstetric-newborn nursing services shall be directed by a

full-time nurse experienced in perinatal nursing, preferably with a master's

degree.

E)        The pediatric-neonatal respiratory therapy services shall be

directed by a full-time respiratory care practitioner with at least three years

experience in all aspects of pediatric and neonatal respiratory therapy, with a

bachelor's degree and completion of the neonatal/pediatric specialty

examination of the National Board for Respiratory Care

sing, preferably with a master's

degree.

E)        The pediatric-neonatal respiratory therapy services shall be

directed by a full-time respiratory care practitioner with at least three years

experience in all aspects of pediatric and neonatal respiratory therapy, with a

bachelor's degree and completion of the neonatal/pediatric specialty

examination of the National Board for Respiratory Care.

F)         Preventive services shall be designated to prevent, detect,

diagnose and refer or treat conditions known to occur in the high risk newborn,

such as: cerebral hemorrhage, visual defects (retinopathy of prematurity), and

hearing loss, and to provide appropriate immunization of high-risk newborns.

G)        A person shall be designated to coordinate the local health

department community nursing follow-up referral process, to direct discharge

planning, to make home care arrangements, to track discharged patients, and to

collect outcome information.  The community nursing referral process shall

consist of notifying the high-risk infant follow-up nurse in whose jurisdiction

the patient resides.  The Illinois Department of Human Services will identify

and update referral resources for the area served by the unit.

H)        Each Level II hospital with Extended Neonatal Capabilities

shall develop, with the help of the APC, a referral agreement with a neonatal

follow-up clinic to provide neuro-developmental assessment and outcome data on

the neonatal population.  Hospital policies and procedures shall describe the

at-risk population and referral procedure to be followed.

I)         If the Level II hospital with Extended Neonatal Capabilities

transports neonatal patients, the hospital shall comply with Guidelines for

Perinatal Care, American Academy of Pediatrics and American College of

Obstetricians and Gynecologists

data on

the neonatal population.  Hospital policies and procedures shall describe the

at-risk population and referral procedure to be followed.

I)         If the Level II hospital with Extended Neonatal Capabilities

transports neonatal patients, the hospital shall comply with Guidelines for

Perinatal Care, American Academy of Pediatrics and American College of

Obstetricians and Gynecologists.

2)         To provide for assisted ventilation of newborn infants beyond

immediate stabilization, the Level II hospital with Extended Neonatal Capabilities

shall also provide the following:

A)        Effective July 1, 2011, a pediatrician or advanced practice

nurse whose professional staff privileges granted by the hospital specifically

include the management of critically ill infants and newborns receiving

assisted ventilation; or an active candidate or board-certified neonatologist

shall be in the hospital the entire time the infant is receiving assisted

ventilation. If infants are receiving on-site assisted ventilation care from an

advanced practice nurse or a physician who is not a neonatologist, an active

candidate or board-certified neonatologist shall be available on call to assist

in the care of those infants as needed.

B)        Suitable backup systems and plans shall be in place to prevent

and respond appropriately to sudden power outage, oxygen system failure, and interruption

of medical grade compressed air delivery.

C)        Nurses caring for infants who are receiving assisted

ventilation shall have documented competence and experience in the care of those

infants.

D)        A respiratory care practitioner with documented competence and

experience in the care of infants who are receiving assisted ventilation shall

also be available to the nursery during the entire time that the infant

receives assisted ventilation

urses caring for infants who are receiving assisted

ventilation shall have documented competence and experience in the care of those

infants.

D)        A respiratory care practitioner with documented competence and

experience in the care of infants who are receiving assisted ventilation shall

also be available to the nursery during the entire time that the infant

receives assisted ventilation.

h)         Application for

Designation, Redesignation or Change in Network

1)         To be

designated or to retain designation, a hospital shall submit the required

application documents to the Department. For information needed to complete any

of the processes, see Section 640.50 and Section 640.60.

2)         The

following information shall be submitted to the Department to facilitate the

review of the hospital's application for designation or redesignation:

A)        Appendix

A (fully completed);

B)        Resource

Checklist (fully completed) (Appendices L, M, N and O);

C)        A

proposed letter of agreement between the hospital and the APC (unsigned); and

D)        The

curriculum vitae for all directors of patient care, i.e., obstetrics, neonatal,

ancillary medical, and nursing (both obstetrics  and neonatal).

3)         When

the information described in subsection (h)(2) is submitted, the Department

will review the material for compliance with this Part. This documentation will

be the basis for a recommendation for approval or disapproval of the applicant

hospital's application for designation.

4)         The

medical co-directors of the APC (or their designees), the medical directors of

obstetrics and maternal and newborn care, and a representative of hospital

administration from the applicant hospital shall be present during the PAC's

review of the application for designation.

5)         The

Department will make the final decision and inform the hospital of the official

determination regarding designation

o-directors of the APC (or their designees), the medical directors of

obstetrics and maternal and newborn care, and a representative of hospital

administration from the applicant hospital shall be present during the PAC's

review of the application for designation.

5)         The

Department will make the final decision and inform the hospital of the official

determination regarding designation. The Department's decision will be based

upon the recommendation of the PAC and the hospital's compliance with this

Part, and may be appealed in accordance with Section 640.45. The Department

shall consider the following criteria or standards to determine if a hospital

is in compliance with this Part:

A)        Maternity

and Neonatal Service Plan (Subpart O of the Hospital Licensing Requirements);

B)        Proposed

letter of agreement between the applicant hospital and its APC in accordance

with Section 640.70;

C)        Appropriate

outcome information contained in Appendix A and the Resource Checklist;

D)        Other

documentation that substantiates a hospital's compliance with particular provisions

or standards of perinatal care set forth in this Part; and

E)        Recommendation of

Department program staff.