Current through Reg. 49, No. 38; September 20, 2024
(a) The department
reviews the applicant documents and approves the appropriate level of facility
designation.
(b) A facility is
defined under this subchapter as a single location where inpatients receive
hospital services or each location if there are multiple buildings where
inpatients receive hospital services and are covered under a single hospital
license.
(c) Each location must be
considered separately for designation and the department approves the
designation level for each location based on the location's ability to
demonstrate designation criteria are met.
(d) The department determines requirements
for the levels of maternal designation. Facilities seeking Levels II, III, and
IV maternal designation must meet department-approved requirements validated by
a department-approved survey organization.
(e) Facilities seeking Level I maternal
designation must submit a self-survey and attest to meeting department-approved
requirements.
(f) The four levels
of maternal designation are:
(1) Level I
(Basic Care). The Level I maternal designated facility must:
(A) provide care for pregnant and postpartum
patients who are generally healthy and do not have medical, surgical, or
obstetrical conditions that present a significant risk of maternal morbidity or
mortality; and
(B) have skilled
personnel with documented training, competencies, and annual continuing
education specific for the patient population served.
(2) Level II (Specialty Care). The Level II
maternal designated facility must:
(A) provide
care for pregnant and postpartum patients with medical, surgical, or
obstetrical conditions that present a low to moderate risk of maternal
morbidity or mortality; and
(B)
have skilled personnel with documented training, competencies, and annual
continuing education specific for the patient population served.
(3) Level III (Subspecialty Care).
The Level III maternal designated facility must:
(A) provide care for pregnant and postpartum
patients with low risk conditions to significant complex medical, surgical, or
obstetrical conditions that present a high risk of maternal morbidity or
mortality;
(B) ensure access to
consultation to a full range of medical and maternal subspecialists and
surgical specialists, and behavioral health specialists;
(C) ensure capability to perform major
surgery on-site;
(D) have
physicians with critical care training available at all times to actively
collaborate with Maternal Fetal Medicine physicians or Obstetrics and
Gynecology physicians with obstetrics training and privileges in maternal
care;
(E) have skilled personnel
with documented training, competencies, and annual continuing education,
specific for the population served;
(F) facilitate transports; and
(G) provide outreach education related to
trends identified through the QAPI Plan, specific requests, and system needs to
lower level designated facilities, and as appropriate and applicable, to
non-designated facilities, birthing centers, independent midwife practices, and
prehospital providers.
(4) Level IV (Comprehensive Care). The Level
IV maternal designated facility must:
(A)
provide comprehensive care for pregnant and postpartum patients with low risk
conditions to the most complex medical, surgical or obstetrical conditions and
their fetuses, that present a high risk of maternal morbidity or
mortality;
(B) ensure access to
on-site consultation to a comprehensive range of medical and maternal
subspecialists, surgical specialists, and behavioral health
specialists;
(C) ensure capability
to perform major surgery on-site;
(D) have physicians with critical care
training available at all times to actively collaborate with Maternal Fetal
Medicine physicians or Obstetrics and Gynecology physicians with obstetrics
training, experience and privileges in maternal care;
(E) have a maternal fetal medicine critical
care team with expertise and privileges to manage or co-manage highly complex,
critically ill or unstable maternal patients;
(F) have a placenta accreta spectrum disorder
multidisciplinary care team with expertise to complete risk factor screening,
evaluation, diagnosis, consultation, and management of patients with
anticipated or unanticipated placenta accreta spectrum disorder, including
postpartum care;
(G) have skilled
personnel with documented training, competencies, and annual continuing
education, specific for the patient population served;
(H) facilitate transports; and
(I) provide outreach education related to
trends identified through the QAPI Plan, specific requests, and system needs to
lower level designated facilities, and as appropriate and applicable, to
non-designated facilities, birthing centers, independent midwife practices, and
prehospital providers.
(g) Facilities seeking maternal designation
must undergo an on-site or virtual survey as outlined in this section and:
(1) are responsible for scheduling a maternal
designation survey through a department-approved survey organization;
(2) must notify the department of the
maternal designation survey date;
(3) are responsible for expenses associated
with the maternal designation survey;
(4) must not accept surveyors with any
conflict of interest; and
(5) must
provide the survey team access to records and documentation regarding the QAPI
Plan and process related to maternal patients.
(h) If a conflict of interest is present for
a facility seeking maternal designation, the facility must decline the assigned
surveyor through the surveying organization. A conflict of interest exists when
a surveyor has a direct or indirect financial, personal, or other interest
which would limit or could reasonably be perceived as limiting the surveyor's
ability to serve in the best interest of the public. The conflict of interest
may include a surveyor that personally trained a key member of the facility's
leadership in residency or fellowship, collaborated with a key member of the
facility's leadership professionally, participated in a designation
consultation with the facility, had a previous working relationship with the
facility or facility leaders, or conducted a designation survey for the
facility within the past four years.
(1)
Surveyors cannot be from the same PCR or TSA region or a contiguous region of
the facility's location.
(2)
Designation site survey summary and record reviews performed by a surveyor with
an identified conflict of interest may not be accepted by the
department.
(i) The
survey team evaluates the facility's evidence that department-approved
designation requirements are met and documents all requirements that are not
met in the maternal designation site survey and medical record
reviews.
