Section 640.43 Level III – Standards for Perinatal Care

Section 640

Section 640.43  Level III

–

Standards for Perinatal Care

To be designated as Level III, a

hospital shall apply to the Department for designation; shall comply with all

of the conditions prescribed in this Part for intensive (Level III) perinatal

care; shall comply with all of the conditions prescribed in Subpart O of the

Hospital Licensing Requirements 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 III − General Provisions

1)         A Level III hospital shall provide all services outlined for

Level I and II (Sections 640.41(a) and 640.42(a)), general, intermediate and special

care, as well as diagnosis and treatment of high-risk pregnancy and neonatal

problems. Both the obstetrical and neonatal services shall achieve Level III

capability for Level III designation.  The hospital shall provide for the

education of allied health professionals and shall accept selected maternal and

neonatal transports from Level I, Level II and Level II with Extended Neonatal

Capabilities hospitals.

2)         The Level III hospital shall make available a range of

technical and subspecialty consultative support such as pediatric

anesthesiology, ophthalmology, pediatric surgery, genetic services, intensive

cardiac services and intensive neurosurgical services.

3)         To qualify as a Level III hospital, these standards and

resource requirements are necessary to ensure adequate competence in the

management of certain high-risk patients. These criteria will be assessed by

reviewing the resources and outcomes of each hospital's admissions, and which

admissions include patients who are subsequently transferred, for the three

most recent calendar years, combined, for which data are available

tal, these standards and

resource requirements are necessary to ensure adequate competence in the

management of certain high-risk patients. These criteria will be assessed by

reviewing the resources and outcomes of each hospital's admissions, and which

admissions include patients who are subsequently transferred, for the three

most recent calendar years, combined, for which data are available.

4)         A Level III hospital that elects not to provide all of the

advanced level services shall have established policies and procedures for

transfer of these mothers and infants to a hospital that can provide the

service needed.

5)         The Level III hospital shall maintain a system for recording

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

transports to meet requirements 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 III – Standards of Care

1)         The Level III hospital shall have a policy requiring general

obstetricians and newborn care physicians to obtain consultations from or

transfer care to the appropriate subspecialists as outlined in the standards

for Level II.

2)         The

Level III hospital shall accept all medically eligible Illinois residents.

Medical eligibility is to be determined by the obstetric or neonatal director

or his/her designee based on the Criteria for High-Risk Identification

(Guidelines for Perinatal Care, American Academy of Pediatrics and American

College of Obstetricians and Gynecologists).

3)         The

Level III hospital shall provide or facilitate emergency transportation of

patients referred to the hospital in accordance with guidelines for inter-hospital

care of the perinatal patient (Guidelines for Perinatal Care))

Criteria for High-Risk Identification

(Guidelines for Perinatal Care, American Academy of Pediatrics and American

College of Obstetricians and Gynecologists).

3)         The

Level III hospital shall provide or facilitate emergency transportation of

patients referred to the hospital in accordance with guidelines for inter-hospital

care of the perinatal patient (Guidelines for Perinatal Care)). If the Level

III hospital is unable to accept the patient referred, the APC Level III

hospital shall arrange for placement at another Level III hospital or

appropriate Level II or Level II hospital with Extended Neonatal Capabilities.

4)         The

Level III hospital shall have a clearly identifiable telephone number,

facsimile number or other electronic communication, either a special number or

a specific extension answered by unit personnel, for receiving consultation

requests and requests for admissions. This number shall be kept current with

the Department and with the Regional  Perinatal Network.

5)         The

Level III hospital shall provide and document continuing education for medical,

nursing, respiratory therapy, and other staff providing general, intermediate

and intensive care perinatal services.

6)         The

Level III hospital shall provide caesarean section decision-to-incision

capabilities within 30 minutes.

7)         The

Level III hospital shall provide data relating to its activities and shall

comply with the requirements of the State Perinatal Reporting System.

8)         The

medical co-directors of the Level III hospital shall be responsible for

developing a system ensuring adequate physician-to-physician communication.

Communication with referring physicians of patients admitted shall be

sufficient to report patient progress before and at the time of discharge

tivities and shall

comply with the requirements of the State Perinatal Reporting System.

8)         The

medical co-directors of the Level III hospital shall be responsible for

developing a system ensuring adequate physician-to-physician communication.

Communication with referring physicians of patients admitted shall be

sufficient to report patient progress before and at the time of discharge.

9)         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.

10)         The

Level III hospital, in collaboration with the APC, shall establish policies and

procedures for the return transfer of high-risk mothers and infants to the

referring hospital when they no longer require the specialized care and

services of the Level III hospital.

11)         The

Level III hospital shall provide backup systems and plans shall be in place to

prevent and respond to sudden power outage, oxygen system failure and

interruption of medical grade compressed air delivery.

12)         The

Level III hospital shall provide or develop a referral agreement with a

developmental follow-up clinic to provide neuro-developmental services for the

neonatal population.  Hospital policies and procedures shall describe the

at-risk population and the referral procedure to be followed for enrolling the

infant in developmental follow-up.  Infants shall be scheduled for assessments

at regular intervals.  Neuro-developmental assessments shall be communicated to

the primary care physicians. Referrals shall be made for interventional care in

order to minimize neurologic sequelae

icies and procedures shall describe the

at-risk population and the referral procedure to be followed for enrolling the

infant in developmental follow-up.  Infants shall be scheduled for assessments

at regular intervals.  Neuro-developmental assessments shall be communicated to

the primary care physicians. Referrals shall be made for interventional care in

order to minimize neurologic sequelae. A system shall be established to track,

record and report neuro-developmental outcome data for the population, as

required to support network CQI activities.

13)         Neonatal

surgical services shall be available 24 hours a day.

c)         Level III – Resource Requirements

1)         Obstetric

activities shall be directed and supervised by a full-time subspecialty

obstetrician certified by the American Board of Obstetrics and Gynecology in

the subspecialty of Maternal and Fetal Medicine, or an  osteopathic physician

with equivalent training and experience and certification by the American Osteopathic

Board of Obstetricians and Gynecologists. The director of the obstetric

services shall ensure the backup supervision of his or her services by a

physician with equivalent credentials.

2)         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/Neonatal-Perinatal

Medicine. The director of the neonatal services shall ensure the backup

supervision of his or her services by a physician with equivalent credentials.

3)         An

administrator/manager with a master's degree shall direct, in collaboration

with the medical directors, the planning, development and operation of the

non-medical aspects of the Level III hospital and its programs and services

tal

Medicine. The director of the neonatal services shall ensure the backup

supervision of his or her services by a physician with equivalent credentials.

3)         An

administrator/manager with a master's degree shall direct, in collaboration

with the medical directors, the planning, development and operation of the

non-medical aspects of the Level III hospital and its programs and services.

A)        The

obstetric and newborn nursing services shall be directed by a full-time nurse

experienced in perinatal nursing, with a master's degree.

B)        Half

of all neonatal intensive care direct nursing care hours shall be provided by

registered nurses who have two years or more of nursing experience in a Level

III NICU.  All NICU direct nursing care hours shall be provided or supervised

by  registered nurses who have advanced neonatal intensive care training and

documented competence in neonatal pathophysiology and care technologies used in

the NICU. All nursing staff working in the NICU shall have yearly competence

assessment in neonatal intensive care nursing.

4)         Obstetric

anesthesia services under the direct supervision of a board- certified

anesthesiologist with training in maternal, fetal and neonatal anesthesia shall

be available 24 hours a day. The directors of obstetric anesthesia services

shall ensure the backup supervision of their services when they are

unavailable.

5)         Pediatric-neonatal

respiratory care services shall be directed by a full-time  respiratory care

practitioner with a bachelor's degree.

A)        The

respiratory care practitioner responsible for the NICU shall have at least

three years of experience in all aspects of pediatric and neonatal respiratory

care at a Level III NICU and completion of the neonatal/pediatrics specialty

examination of the National Board for Respiratory Care

vices shall be directed by a full-time  respiratory care

practitioner with a bachelor's degree.

A)        The

respiratory care practitioner responsible for the NICU shall have at least

three years of experience in all aspects of pediatric and neonatal respiratory

care at a Level III NICU and completion of the neonatal/pediatrics specialty

examination of the National Board for Respiratory Care.

B)        Respiratory

care practitioners with experience in neonatal ventilatory care shall staff the

NICU according to the respiratory care requirements of the patient population,

with a minimum of one dedicated neonatal respiratory care practitioner for

newborns on assisted ventilation, and with additional staff provided as

necessary to perform other neonatal respiratory care procedures.

6)         A

physician for the program shall assume primary responsibility for initiating,

supervising and reviewing the plan for management of distressed infants in the

delivery room. Hospital policies and procedures shall assign responsibility for

identification and resuscitation of distressed neonates to individuals who are

both specifically trained and immediately available in the hospital at all

times. Capability to provide neonatal resuscitation in the delivery room may be

satisfied by current completion of a neonatal resuscitation program by medical,

nursing and respiratory care staff or a rapid response team.

7)         A

board-certified or active candidate obstetrician shall be present and available

in the hospital 24 hours a day. Maternal-fetal medicine consultation shall be

available 24 hours a day.

8)         Medical

director-neonatal: to direct the neonatal portion of the program

etion of a neonatal resuscitation program by medical,

nursing and respiratory care staff or a rapid response team.

7)         A

board-certified or active candidate obstetrician shall be present and available

in the hospital 24 hours a day. Maternal-fetal medicine consultation shall be

available 24 hours a day.

8)         Medical

director-neonatal: to direct the neonatal portion of the program.  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 certified by the American Osteopathic Board of

Pediatricians/Neonatal-Perinatal Medicine.  The directors of the neonatal

services shall ensure the back-up supervision of their services when they are

unavailable.

9)         Neonatal

surgical services shall be supervised by a board-certified surgeon or active

candidate in pediatric surgery appropriate for the procedures performed at the

Level III hospital.

10)       Neonatal

surgical anesthesia services under the direct supervision of a board-certified

anesthesiologist with extensive training or experience in pediatric

anesthesiology shall be available 24 hours a day.

11)       Neonatal

neurology services under the direct supervision of a board-certified or active

candidate pediatric neurologist shall be available for consultation in the NICU

24 hours a day.

12)       Neonatal

radiology services under the direct supervision of a radiologist with extensive

training or experience in neonatal radiographic and ultrasound interpretation

shall be available 24 hours a day.

13)       Neonatal

cardiology services under the direct supervision of a pediatric board-certified

or active candidate by the American Board of Pediatrics sub-board of pediatric

cardiology shall be available for consultation 24 hours a day

upervision of a radiologist with extensive

training or experience in neonatal radiographic and ultrasound interpretation

shall be available 24 hours a day.

13)       Neonatal

cardiology services under the direct supervision of a pediatric board-certified

or active candidate by the American Board of Pediatrics sub-board of pediatric

cardiology shall be available for consultation 24 hours a day.  In addition,

cardiac ultrasound services and pediatric cardiac catheterization services by

staff with specific training and experience shall be available 24 hours a day.

14)       A

board-certified or active candidate ophthalmologist with experience in the

diagnosis and treatment of the visual problems of high-risk newborns (e.g.,

retinopathy of prematurity) shall be available for appropriate examinations,

treatment and follow-up care of high-risk newborns.

15)       Pediatric

sub-specialists with specific training and extensive experience or subspecialty

board certification or active candidacy (where applicable) shall be available

24 hours a day, including, but not limited to, pediatric urology, pediatric

otolaryngology, neurosurgery, pediatric cardiothoracic surgery and pediatric

orthopedics appropriate for the procedures performed at the Level III hospital.

16)       Genetic

counseling services shall be available for inpatients and outpatients, and the

hospital shall provide for genetic laboratory testing, including, but not

limited to, chromosomal analysis and banding, fluorescence in situ

hybridization (FISH), and selected allele detection.

17)       The

Level III hospital shall designate at least one person to coordinate the

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

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

appropriate enrollment in a developmental follow-up program

analysis and banding, fluorescence in situ

hybridization (FISH), and selected allele detection.

17)       The

Level III hospital shall designate at least one person to coordinate the

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

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

appropriate enrollment in a developmental follow-up program.  The community

nursing referral process shall consist of notifying the follow-up nurse in

whose jurisdiction the patient resides of discharge information on all

patients. The Illinois Department of Human Services will identify and update

referral resources for the area served by the unit. The hospital shall

establish a protocol that defines the educational criteria necessary for

commonly required home care modalities, including, but not limited to,

continuous oxygen therapy, electronic cardio-respiratory monitoring,

technologically assisted feeding and intravenous therapy.

18)       One

or more full-time  social workers with perinatal/neonatal experience shall be available

to the Level III hospital.

19)       One

registered pharmacist with experience in perinatal pharmacology shall be

available for consultation on therapeutic pharmacology issues 24 hours a day.

20)       One

dietitian with experience in perinatal nutrition shall be available to plan

diets and education to meet the special needs of high-risk mothers and neonates

in both inpatient and outpatient settings.

d)         Application for Hospital

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

needs of high-risk mothers and neonates

in both inpatient and outpatient settings.

d)         Application for Hospital

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 (d)(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

nt 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;

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.