Fla. Admin. Code Ann. R. 64C-6.003 - Standards - Specific

(1) Standards for Neonatal Component - Level III Neonatal Intensive Care - The following standards pertain to the facilities, services, and population to be served under the neonatal component for Level III neonatal intensive care services.

(a) Personnel.

1. Physicians.

a. The director of the RPICC neonatal unit shall be a CMS consultant neonatologist.

b. Each center shall have available a CMS consultant pediatric surgeon available at all times.

c. Each RPICC neonatal unit shall have 24-hour coverage by CMS consultant neonatologists for patient care and for communication with physicians in other hospitals.

d. Each center shall have a CMS consultant pediatric cardiologist available at all times.

e. Two neonatologists are required within 3 years of designation of a unit as a RPICC.

2. Nurses.

a. A head nurse, who is registered by the State of Florida, as defined in Chapter 464, F.S., with training and experience in neonatal intensive care nursing, shall be responsible for the organization and quality of nursing care provided in the RPICC neonatal unit.

b. Additional staffing for each shift for infants requiring intensive care shall include, as a minimum, a ratio of one member of the nursing staff to two patients for the critical care of unstable neonates. Half of the nursing personnel must be registered nurses.

This ratio of nurses to infants shall be maintained at all times.

3. Respiratory Therapy Technician - At least one certified respiratory therapy technician, with expertise in the care of neonates, shall be available in the hospital at all times. One therapist for every four infants receiving assisted ventilation is required.

(b) Area and Equipment - All standards in subsection 59C-1.042(10), F.A.C., which is hereby incorporated by reference, are required. In addition, the following standards are also required.

1. Each patient station in the RPICC Level III neonatal intensive care unit shall have:

a. Availability of continuous blood pressure measurement.

b. Availability of devices capable of measuring continuous arterial oxygenation in the patient.

2. Each RPICC neonatal unit shall have one ventilator available for every three intensive care beds.

(c) Patient Eligibility.

1. Eligibility for funding under the RPICC Program shall be limited to neonates admitted to the Level III neonatal intensive care unit in one of the designated RPICCs. All neonates who meet the established medical criteria upon direct referral by the attending physician, must be admitted to the center, regardless of geographic origin in Florida or financial eligibility. The only valid grounds for refusal of admission to a center shall be the lack of functional bed space or unavailability of transport. Admission to a center does not constitute acceptance of a patient for eligibility under the RPICC Program.

2. All neonates admitted to a center shall be evaluated for RPICC Program eligibility. Only those patients who meet both the medical and financial criteria shall be eligible for the RPICC Program.

3. The following medical criteria will be considered by the RPICC director of neonatology, or designee, to determine medical eligibility for each neonate admitted to the center or under this program:

a. All low birth weight neonates under 1500 grams.

b. All low birth weight neonates from 1500 to 2500 grams with any of the following:

(I) Birth asphyxia or 5 minute Apgar of 6 or less.

(II) Oxygen dependent respiratory disease.

(III) A specific medical illness.

c. Neonates over 2500 grams birth weight with any of the following:

(I) Birth asphyxia or 5 minute Apgar of 6 or less.

(II) The need for supplemental oxygen for more than 24 hours.

(III) A specific medical illness.

4. All referred infants who meet at least one of the above criteria are medically eligible. Infants who are born at a center hospital must require more than 48 hours of care in an intensive care bed to be medically eligible under any of the specific medical diagnostic categories. Inborn neonates who die prior to receiving 48 hours of care in an intensive care bed may be medically eligible for the program.

5. Only neonates whose attending physician is a CMS consultant neonatologist in a RPICC center are eligible for the RPICC Program. Neonates who are patients of other physicians or neonates referred to other physicians by the neonatologist, are not eligible for the RPICC Program.

(d) Services.

1. Physician Services - The patient record shall contain written comments on the patient's treatment and condition by the CMS consultant neonatologist or a resident's note co-signed by the CMS consultant documenting the neonatologist's continuing involvement in the care of the neonate.

2. Nursing Services - Nurses working in the neonatal intensive care unit (NICU) shall have knowledge and skills in the following:

a. Cardio-respiratory monitoring.

b. Assisting in ventilation and administering I.V. fluids.

c. Pre-operative and post-operative care of newborns requiring surgery.

d. Providing emergency treatment of conditions such as apnea and seizures.

e. Management of neonates being transported to the center.

3. Laboratory and X-Ray Services.

4. Nutrition Services - Each center shall have a dietician or nutritionist to provide information on patient dietary needs while in the center and to provide the patient or patient's family instruction or counseling regarding the appropriate nutritional and dietary needs of the patient after discharge.

5. Respiratory Therapy Services.

6. Social Services.

7. Each center shall provide a written discharge plan for each RPICC Program neonate.

(2) Standards for Neonatal Component - Level II neonatal intensive care unit - The following standards pertain to the facilities, services, and population to be served under the neonatal component for Level II neonatal intensive care services of the RPICC Program.

(a) Personnel.

1. Physicians.

a. Each Level II neonatal intensive care unit shall have 24 hour consultation and primary coverage by CMS consultant neonatologists for patient care.

2. Nurses.

a. A head nurse, who is registered by the State of Florida, as defined in Chapter 464, F.S., with specialized training and experience in the care of sick infants, will be responsible for the organization and quality of nursing care in the Level II neonatal intensive care unit. The head nurse of the Level III neonatal intensive care unit may assume this role.

b. Additional staffing for each shift for infants in the Level II neonatal intensive care unit must include one member of nursing staff for every four such infants, with a minimum of half of such nursing personnel being registered nurses. This ratio of nurses to infants must be maintained at all times.

3. Respiratory Therapy Technician - A certified respiratory therapy technician with expertise in the care of neonates shall be available to the Level II neonatal intensive care unit at all times.

(b) Area and Equipment - All standards in subsection 59C-1.042(9), F.A.C., which is hereby incorporated by reference, are required. In addition, the following standards are also required:

1. Each Level II neonatal intensive care unit shall have available to the unit on demand the availability of continuous blood pressure measurement.

2. Each Level II neonatal intensive care unit shall have available the capability for short-term assisted ventilation until return to a RPICC Level III neonatal intensive care unit is available.

(c) Patient Eligibility.

1. Eligibility for funding under the RPICC Program shall be limited to neonates admitted to the Level II neonatal intensive care unit from one of the designated RPICC Level III neonatal intensive care units.

2. Infants served in Level II neonatal intensive care units shall be under the care of a CMS consultant neonatologist, must have received CMS RPICC Program Level III NICU care, and may require specialized nutritional support, or may require oxygen which does not exceed 40 percent at ambient pressure, or whose weight or medical or surgical diagnosis precludes discharge to recovery care.

(d) Services.

1. Physician Services.

2. Nursing Services.

3. Laboratory and X-Ray Services.

4. Nutrition Services.

5. Respiratory Therapy Services.

6. Social Services.

(3) Standards for Obstetrical (OB) Component - The following standards pertain to the facilities, services, and population to be served under the obstetrical component of the RPICC Program.

(a) Personnel.

1. Physicians.

a. The obstetrical service shall have 24-hour coverage by a CMS consultant obstetrician for patient care and for communication with physicians in other hospitals.

b. An anesthesiologist, with special training or experience in maternal-fetal anesthesia, shall direct anesthesia services.

c. Specialists in pediatrics, internal medicine, cardiology, surgery, and genetics shall be available to provide consultation.

2. Nurses.

a. The nursing supervisor for obstetrics, registered by the State of Florida, as defined in Chapter 464, F.S., shall have training and experience in the nursing care of normal and high risk obstetric patients, and shall preferably be certified as a clinical nurse specialist or advanced registered nurse practitioner.

b. Each outpatient, antepartum, postpartum, and labor and delivery area shall have a registered nurse, with experience in the specific area and experience in the management of high risk obstetrical patients, who shall be responsible for the organization and quality of nursing care provided in that area.

(b) Area and Equipment.

1. Outpatient Area.

a. The outpatient area shall have available a waiting room of adequate size. Each patient shall be afforded privacy during the examination and there shall be available a dressing area which assures the patient privacy. Toilet facilities shall be located near the examining rooms. An area for displaying patient education materials shall be available.

b. Equipment necessary for pre or postnatal examinations shall be available in the clinic area.

c. An emergency cart with the necessary medications and equipment for maternal and infant resuscitation and an emergency delivery set shall be available in the clinic area.

2. Labor and Delivery Area - The labor and delivery area shall have, as a minimum:

a. An observation area available for patients who are not in active labor, but who are being observed for labor and a room available and equipped for patients requiring obstetrical intensive care.

b. One fetal monitor per five hundred deliveries per year or two fetal monitors for less than one thousand five hundred deliveries per year for continuous direct and indirect electronic fetal monitoring.

c. Equipment for continuous electronic cardiac monitoring.

d. EKG equipment with printout capability.

e. Intravenous solutions and infusion pumps.

f. Equipment for obtaining fetal scalp blood samples.

g. An emergency cart with the necessary medications and equipment for maternal and infant resuscitation and an emergency delivery set.

h. Each labor room shall have, as a minimum:

(I) A labor bed with adjustable side rails and a foot stool.

(II) A sphygmomanometer and stethoscopes, both regular and fetal.

(III) Oxygen and suction equipment.

i. Each delivery room shall have, as a minimum:

(I) A delivery table that will allow variation in position for delivery.

(II) A sphygmomanometer and stethoscopes, both regular and fetal.

(III) Equipment for inhalation and regional anesthesia, including equipment for emergency resuscitation.

(IV) Oxygen and suction for mother and infant.

(V) Instruments and equipment for normal or operative delivery.

(VI) Necessary medications for mother and infant.

(VII) Heated infant examination and resuscitation unit, including laryngoscopes, endotracheal tubes, drugs, and suction catheters, and the necessary equipment for the adequate identification of the infant.

(VIII) Wall clock with second hand.

3. OB Recovery Room

a. A separate recovery room shall be available for patients following deliver and shall be located in close proximity to the delivery room.

b. The recovery room shall have as a minimum:

(I) Oxygen and suction equipment at each patient station.

(II) Sphygmomanometers and stethoscopes.

(III) Emergency drugs and resuscitation equipment.

(IV) EKG equipment.

4. Antepartum and Postpartum Area

a. A separate bed area shall be available for undelivered patients who are designated as "high risk."

b. The antepartum and postpartum unit shall have, as a minimum:

(I) Sphygmomanometers and stethoscopes.

(II) Fetoscopes or external fetal monitoring equipment.

(III) Sterile amniocentesis tray, available at all times.

(IV) Oxygen and suction at each patient station.

(V) I.V. solutions and supplies.

(VI) Emergency drugs and resuscitation equipment.

(VII) An emergency delivery set.

(c) Patient Eligibility.

1. Eligibility for RPICC Program sponsorship shall be limited to pregnant women residing in the State of Florida who meet both current CMS financial eligibility criteria and medical eligibility criteria.

2. Determination of medical eligibility of pregnant women for RPICC sponsorship shall be made by the RPICC director of obstetrics or CMS obstetrician consultant designee at the time of referral or following the initial examination at the center. The final medical decision for admission of a patient to a center shall be made by the director of obstetrics or CMS obstetrician consultant designee.

3. Demographic, medical, and fiscal data shall be collected on all RPICC Program patients, and entered into the RPICC data system.

4. The director of obstetrics or designee shall consider major maternal conditions which may significantly alter the usual management of pregnancy or of the newborn when determining medical eligibility for RPICC Program sponsorship. Major maternal conditions to be considered include, but are not limited to the following:

a. Severe pregnancy induced hypertension (BP 160/110) or eclampsia.

b. Isoimmune disease in a patient who has had a previously affected infant.

c. Labor or ruptured membranes at less than 34 weeks gestation or, anticipated severe neonatal infection.

d. Uterine bleeding or central placenta previa at less than 34 weeks gestation, requiring delivery or continued intensive hospitalization.

e. Diabetes mellitus, requiring insulin.

5. Only patients whose attending physician is a CMS consultant obstetrician in a center are eligible for RPICC Program funding.

6. A patient record on each RPICC Program pregnant woman shall be maintained by the center liaison and shall include patient eligibility information and patient demographic, medical, and fiscal data.

7. Termination of Program Eligibility.

a. Financial Eligibility.

(I) A patient's financial status may be reviewed at any time following her acceptance into the RPICC Program.

(II) If a patient is determined financially ineligible for RPICC Program sponsorship, the patient's enrollment in the program shall be terminated, only if referred elsewhere for medical care, as documented in the record.

b. Medical Eligibility.

(I) The obstetric director, or obstetrician designee, may terminate a patient's sponsorship under the program if the condition for which the patient was admitted to the RPICC Program no longer exists, only if the patient is referred elsewhere for medical care, as documented in the record.

(II) The obstetrician or designee shall provide written notification to the patient and referring physician or clinic of the termination of RPICC Program sponsorship.

(d) Services.

1. Physician.

a. Patient management at designated centers shall include, but not be limited to, availability of the following tests:

(I) Amniocentesis.

(II) Ultrasound.

(III) Antepartum and intrapartum electronic fetal monitoring.

(IV) Intrauterine transfusion.

(V) Fetal scalp blood sampling.

b. Performance or interpretation of these tests shall be made by, or under the supervision of the CMS consultant obstetrician.

2. Nursing services shall include, but not be limited to:

a. Assessment of the patient's health status during the antepartum, intrapartum and postpartum periods of hospitalization.

b. Monitoring the patient's condition, oxytocin induction management and fetal monitoring interpretation.

c. Nursing management of complications occurring during antepartum, intrapartum, and postpartum periods of hospitalization.

d. Patient education, including but not limited to, dietary and family planning counseling, postpartum instruction and infant care.

e. In addition to other routine functions, the nurse shall have knowledge and skills in:

(I) Initiation of fluid replacement by I.V. catheter or needle and management of intravenous infusions, including medications.

(II) Managing blood transfusions.

(III) Administering oxygen.

(IV) Performing external cardiac massage.

(V) Maintaining respiration and patent airway.

(VI) Management of spontaneous delivery and third stage of labor.

(VII) Newborn resuscitation.

3. Twenty-four hour anesthesia services.

4. Capability for performing cesarean sections in the delivery room, within 15 minutes.

5. Capability for obtaining intra-arterial blood pressure.

6. Ancillary health services to include:

a. Twenty-four hour blood bank services.

b. Twenty-four hour routinely available X-ray services, with capability for performing diagnostic ultrasound examinations capable of determining placental position and fetal cephalometry, if this service is not provided by the obstetric department.

c. Twenty-four hour laboratory services, with capabilities for performing amniotic fluid analysis, including studies of fetal maturity and fetal well-being; and bio-chemical tests of fetal placental well-being, such as either estriol or human placental lactogen measurements.

d. Twenty-four hour respiratory therapy services to include twenty-four hour blood gas determination with capability for microcapillary technique for scalp blood pH determination.

e. Nutrition Services - Each center shall have a dietician or nutritionist to provide information on patient dietary needs relating to pregnancy and fetal nutrition and information on infant nutritional needs.

f. Social Services - Each center shall make available the services of the hospital's social services department to patients and their families which shall include, but are not limited to, patient and family counseling and referral to appropriate agencies for services. Each designated center liaison shall refer all eligible women to the Medicaid Program for consideration of funding.

g. Psychological Services - Each center shall provide for or arrange for access to psychological services to patients and their families which include, but are not limited to patient or family counseling and referral to appropriate mental health agencies for services.

h. Prenatal classes - Each center shall provide for or arrange for access to prenatal classes for patients, as recommended by the CMS consultant obstetrician.

Notes

Fla. Admin. Code Ann. R. 64C-6.003

Rulemaking Authority 383.19 FS. Law Implemented 383.19 FS.

New 9-1-81, Amended 8-25-85, Formerly 10J-7.03, Amended 6-13-87, 5-15-96, Formerly 10J-7.003.

New 9-1-81, Amended 8-25-85, Formerly 10J-7.03, Amended 6-13-87, 5-15-96, Formerly 10J-7.003.