New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter V - Medical Facilities
Subchapter A - Medical Facilities-minimum Standards
Article 1 - General
Part 400 - All Facilities-General Requirements
Section 400.22 - Statewide perinatal data system
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 400.22
Current through Register Vol. 46, No. 52, December 24, 2024
(a) All hospitals and freestanding birthing centers which provide care and services to parturient women and/or neonates shall participate in the statewide perinatal data system by providing required information in accordance with this section. Facilities contributing data to the system may only access data from the system in accordance with this section and other applicable laws and regulations.
(b) As used in this section the following terms shall have the following meanings:
(1)
The statewide perinatal data system (SPDS) shall mean the
electronic maternal and newborn data collection and analysis system established
and maintained by the Department of Health which includes the data elements,
organized in modules, which comprise the New York State certificate of live
birth for births occurring in New York State outside of New York City, or the
New York City certificate of live birth for births occurring in New York City,
and other data elements which relate to maternal and newborn health and care in
hospitals and free-standing birthing centers.
(2) The core module shall be
the New York State certificate of live birth, a data set consisting of elements
specified by the Commissioner of Health and collected for all parturient women
and newborns in New York State outside of New York City; and for births
occurring in New York City, the core module shall be the New York City
certificate of live birth, a data set consisting of elements specified by the
New York City Commissioner of Health and Mental Hygiene and collected for all
parturient women and newborns in New York City.
(3) The supplemental module
shall mean a set of data supplied by the patient consisting of data elements
specified by the Commissioner of Health in consultation with the Commissioner
of the New York City Department of Health and Mental Hygiene. Supplemental
module data elements shall be related to quality of prenatal care and maternal
factors that may be related to birth outcomes.
(4) The high risk obstetric
module shall mean a data set consisting of data elements that provide
clinically-relevant information on pregnant women who are referred to
obstetricians for specialty care in the antepartum period or who are
transported to a higher level facility for delivery or care in the antepartum,
intrapartum or postpartum period. Elements will be as specified by the
Commissioner of Health in consultation with the Commissioner of the New York
City Department of Health and Mental Hygiene concerning all pregnant women
identified as having high risk pregnancies, inclusive of maternal transports to
higher levels of care. The data elements shall supplement core module data,
providing additional data on clinical risk status and interventions for high
risk births.
(5) The high
risk neonatal module (NICU module) shall mean a data set consisting of
data elements that provide clinically-relevant information on the neonate at
the time of entry to the neonatal intensive care unit. The elements will be as
specified by the Commissioner of Health in consultation with the Commissioner
of the New York City Department of Health and Mental Hygiene and data will be
collected on all neonates entering all special care and intensive care
nurseries for longer than four hours. The high risk neonatal module shall also
include information on all newborns who die in the delivery room, in transit to
the neonatal special or intensive care unit, and in the neonatal special or
intensive care units. The data elements shall supplement core module data,
providing additional data on clinical risk status and interventions for high
risk newborns.
(6) The
newborn Medicaid eligibility module shall consist of the
Medicaid client identification number (CIN) and other Medicaid-specific
information as specified by the Commissioner of Health, and shall be available
solely to authorized Office of Medicaid Management staff and departmental staff
authorized to help maintain the SPDS files and the programming required
thereby.
(7)
De-identified
patient data shall mean data from which individual patient names have
been expunged and other identifiers have been modified so that there is no
reasonable basis to believe that individual patients can be identified by using
such data except by the facility which provided the patient care and
services.
(8)
Quality
improvement shall mean any use or analysis of SPDS data that
identifies for further investigation any poor outcomes potentially amenable to
intervention (sentinel events), trends by hospital, hospital level or region,
potential problem areas or any issues with quality of care; and further, may
lead to improvement of the care provided by the regional perinatal center, its
affiliate hospitals or regional perinatal system providers through development
of initiatives designed to address the potential problems identified, or to
improve the quality of the data collected via the SPDS.
(9)
Target area for a community-based
organization under contract to the New York State Department of Health
shall mean the organization's specified area of operation and/or influence as
noted in their current contract.
(c) Participation in the statewide perinatal data system (SPDS).
(1) All
hospitals and freestanding birthing centers that provide perinatal health care
services shall participate in the statewide perinatal data system. All live
births shall be entered into the state perinatal data system. For births
occurring in New York City, the core module shall be implemented on January 1,
2007.
(2) Each hospital and
freestanding birthing center shall submit core module data to the agency
responsible for collecting birth records. In addition, all hospitals shall
submit data from the supplemental module, the high risk obstetric module, and
the Medicaid eligibility module, and, if the hospital has a neonatal special or
intensive care unit, from the high risk neonatal module as well, to the
department in a form and manner prescribed by the department. The hospital
shall be responsible for retaining signed consent forms, if any, for at least
six years. The hospital will only transmit data as required under the
regulations and any additional data for which it has consent, when consent is
needed. Data elements in the system shall address the following:
(i) mother's Medicaid information to be used
only to determine newborns' Medicaid eligibility;
(ii) public health surveillance of birth
outcomes; and
(iii) improvement of
prenatal, obstetric, and newborn care for mothers and infants.
(3) New York City Department of
Health and Mental Hygiene will continue to exercise oversight of the use and
release of the New York City birth certificate and the information contained
therein. Nothing contained herein shall abridge the authority of the New York
City Department of Health and Mental Hygiene to maintain the New York City
Vital Records System. Nothing contained herein shall abridge the authority of
the New York State Department of Health to maintain the New York Vital Records
System outside of New York City.
(4) Access to SPDS data shall be limited to
staff authorized by the Department of Health, and in the case of core module
data for births occurring in hospitals and freestanding birthing centers
located in New York City, staff authorized by the New York City Department of
Health and Mental Hygiene, in the following settings for the purposes
specified. Identifying SPDS information may be disclosed to authorized staff
when and to the extent the disclosure is consistent with the Public Health Law,
and for core module data from New York City consistent with applicable New York
City law and regulations, and necessary to conform to an identified requirement
of the Public Health Law or one of its implementing regulations and when that
disclosure is not otherwise prohibited or restricted by or inconsistent with
the Public Health Law or its implementing regulations.
(i) Authorized staff of a facility shall have
access to data submitted to the SPDS by that facility, with the exclusion of
the Medicaid eligibility module; use of data shall conform with facility
policies regarding use of confidential data.
(ii) A regional perinatal center shall have
access to de-identified data submitted to the SPDS by its perinatal affiliates,
with the exclusion of the Medicaid eligibility module, with a unique identifier
that can be linked to identifying information only by the originating hospital
for reference in evaluation of patient outcomes as specified in section
721.9 of this Title. De-identified
data may also be used to monitor regional trends.
(iii) A comprehensive prenatal/perinatal
services network or other community-based organization under contract to the
Department of Health may be given access to available selected aggregate core
and supplemental module data about births within its target area with all
patient and provider identifiers eliminated. The level of aggregation and/or
the geographic area targeted must ensure that no patients or providers are able
to be identified from the data provided. Data shall be used only in furtherance
of the organization's role in assessing and improving perinatal health in their
target area, as specified in their contract with the department.
(iv) Staff authorized by the Department of
Health shall have access to individual-level perinatal data system data
reported by hospitals and freestanding birthing centers except in the case of
core module data for births occurring in hospitals and freestanding birthing
centers located in New York City, where staff access to core module data will
be authorized by the New York City Department of Health and Mental Hygiene. For
births occurring in hospitals and freestanding birthing centers located in New
York City, SPDS data, including core and supplemental modules, shall be
available to the New York City Department of Health and Mental
Hygiene.
(v) Regional perinatal
centers, affiliate hospitals and freestanding birthing centers with access to
the data in the statewide perinatal data system (SPDS) shall not use the data
for purposes other than quality improvement as defined in these regulations.
SPDS data is confidential and must be appropriately secured by the regional
perinatal centers, affiliate hospitals and freestanding birthing centers and
shall not be redisclosed, except to the department or its authorized agents or
contractors.
(d) The commissioner shall waive for up to one year, upon request from the New York City Department of Health and Mental Hygiene on behalf of the facilities located within that vital records registration district, the data collection requirements of this section under the following circumstances:
(1) An
application for a waiver must be submitted that:
(i) is received at least three months before
the effective date of the SPDS in the registration district;
(ii) identifies the financial, administrative
or other hardship which necessitates the request;
(iii) describes the measures to be taken to
eliminate the hardship and the anticipated completion date of those measures;
and
(iv) assures continued access
by hospitals to data comparable to that required in this section prior to
implementation of SPDS.
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