SECTION 133.203. General Requirements

(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.

Source Note: The provisions of this §133.203 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986