Section 640.41 Level I – Standards for Perinatal Care

Section 640

Section 640.41  Level I – Standards

for Perinatal Care

To be designated as Level I, a

hospital shall apply to the Department as described in Section 640.60; shall

comply with all 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:

a)         Level I − General Provisions

1)         The Maternity and Neonatal Service Plan shall include:

A)        A letter of agreement between the hospital and its APC establishing

criteria for maternal and neonatal consultation; criteria for maternal and neonatal

transports; standards of care of mothers and neonates; and support services to

be provided.  (Section 640.70 establishes the minimum components for the letter

of agreement.);

B)        Continuing education of staff in perinatal care; and

C)        Participation in the CQI program implemented by the APC.

2)         The critical considerations in the care of patients

anticipating delivery in these hospitals are as follows:

A)        The earliest possible detection of the high-risk pregnancy

(risk assessment); consultation with a maternal-fetal medicine subspecialist or

neonatologist as specified in the letter of agreement; and transfer to the

appropriate level of care; and

B)        The availability of trained personnel and facilities to provide

competent emergency obstetric and newborn care.  Included in the functions of

this hospital are the stabilization of patients with unexpected problems,

initiation of neonatal and maternal transports, patient and community

education, and data collection and evaluation.

3)         The

Level I hospital shall provide continuing education for medical, nursing,

respiratory therapy, and other staff providing general perinatal services, with

evidence of a yearly competence assessment appropriate to the patient

population served

unexpected problems,

initiation of neonatal and maternal transports, patient and community

education, and data collection and evaluation.

3)         The

Level I hospital shall provide continuing education for medical, nursing,

respiratory therapy, and other staff providing general perinatal services, with

evidence of a yearly competence assessment appropriate to the patient

population served.

4)         The Level I hospital shall maintain a system of recording

patient admissions, discharges, birth weight, outcome, complications, and

transports to meet the requirement 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 I – Standards for Maternal Care

1)         The maternal patient with an uncomplicated current pregnancy

and no previous history that suggests potential difficulties is considered

appropriate for Level I hospitals; however, the hospital's letter of agreement

shall establish the specific conditions for the Level I hospital.

2)         Other than those maternal patients identified in subsection

(b)(1), pregnancies of fewer than 36 weeks gestation constitute potentially

high-risk conditions for which the attending health care provider shall consult

with a board-certified obstetrician or maternal-fetal medicine subspecialist to

determine whether a transport or transfer to a higher level of care is needed.

The letter of agreement shall specify policies for consultation and the

hospital's obstetric policies and procedures for each of, but not limited to,

the pregnancy conditions listed in Section 640.Appendix H. Exhibit A.

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 fetal monitoring use

and interpretation

and procedures for each of, but not limited to,

the pregnancy conditions listed in Section 640.Appendix H. Exhibit A.

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 fetal monitoring use

and interpretation. Physicians and nurses shall complete a competence

assessment in electronic maternal-fetal monitoring every two years.

4)         Hospitals

shall provide caesarean section decision-to-incision capabilities within 30

minutes.

c)         Level I – Standards for Neonatal Care

1)         Neonatal patients greater than 36 weeks gestation or greater

than 2500 grams without risk factors and infants with physiologic jaundice are

generally considered appropriate for Level I hospitals; however, the hospital's

letter of agreement shall establish the specific conditions for Level I hospitals.

2)         For all neonatal patients other than those identified in

subsection (c)(1), consultation with a neonatologist is required to determine

whether a transport to a higher level of care is needed. Consultation shall be

specified in the letter of agreement and outlined in the hospital's pediatric

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

A)        Small-for-gestational age (less than 10

th

percentile)

B)        Documented sepsis

C)        Seizures

D)        Congenital heart disease

E)        Multiple congenital anomalies

F)         Apnea

G)        Respiratory distress

H         Neonatal asphyxia

I)         Handicapping conditions or developmental disabilities that

threaten life or subsequent development

J)         Severe anemia

K)        Hyperbilirubinemia, not due to physiologic cause

L)        Polycythemia

d)

Level I – Resource Requirements

The following

support services shall be available:

1)         Blood bank technicians shall be on call and available within

30 minutes for performance of routi

ndicapping conditions or developmental disabilities that

threaten life or subsequent development

J)         Severe anemia

K)        Hyperbilirubinemia, not due to physiologic cause

L)        Polycythemia

d)

Level I – Resource Requirements

The following

support services shall be available:

1)         Blood bank technicians shall be on call and available within

30 minutes for performance of routine blood banking procedures.

2)         General anesthesia services shall be on call and available

within 30 minutes to initiate caesarean sections.

3)         Radiology services shall be available within 30 minutes.

4)         Clinical laboratory services shall include microtechnique for

hematocrit, blood gases, and routine urinalysis within 15 minutes; glucose, blood

urea nitrogen (BUN), creatinine,  complete blood count (CBC), routine blood

chemistries, type, cross, Coombs' test and bacterial smear within one hour; and

capability for bacterial culture and sensitivity and viral culture.

5)         A physician for the program shall be designated to assume

primary responsibility for initiating, supervising and reviewing the plan for management

of distressed infants.  Policies and procedures shall assign responsibility for

identification and resuscitation of distressed neonates to individuals who have

completed a nationally recognized neonatal resuscitation program and are both

specifically trained and immediately available in the hospital at all times,

such as another physician, a nurse with training and experience in neonatal

resuscitation, or a respiratory care practitioner.

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

rained and immediately available in the hospital at all times,

such as another physician, a nurse with training and experience in neonatal

resuscitation, or a respiratory care practitioner.

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 (Designation and Redesignation of

Non-Birthing Center, Level I, Level II, Level II with Extended Neonatal

Capabilities, Level III Perinatal Hospitals, and Administrative Perinatal

Centers) and Section 640.60 (Application for Hospital Designation and

Redesignation as Non-Birthing Center, Level I, Level II, Level II with Extended

Neonatal Capabilities, Level III Perinatal Hospital, and Administrative

Perinatal Center, and Assurances Required of Applicants).

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);

C)        A

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

D)        The

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

neonatal,  ancillary medical and nursing.

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

s 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 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

(Appendices L, M, N and O);

D)        Other

documentation that substantiates a hospital's compliance with particular

provisions or standards of perinatal care; and

E)        Recommendation of

Department program staff.