Part I.
Texas Department of Health
Chapter 1.
Texas Board of Health
Subchapter C. Fair Hearing Procedures
25 TAC §1.41
The Texas Department of Health (department) adopts new §1.41
concerning adoption by reference of 1 Texas Administrative Code, Chapter 357,
§§357.1, 357.3, 357.5, 357.7, 357.9, 357.11, 357.13, 357.15, 357.17,
357.19, 357.21, 357.23, 357.25, 357.27, and 357.29, Medicaid fair hearings
rules, adopted by the Texas Health and Human Services Commission regarding
the procedures for fair hearings for recipients in the Medicaid program. The
section is adopted with changes to the proposed text as published in the April
9, 1999, issue of the
Texas Register
(24 TexReg
2841).
Specifically, new §1.41 will standardize the fair hearing process
for all Medicaid funded services so that recipients may participate in uniform
hearings conducted by the Texas Department of Health, Texas Health and Human
Services Commission (HHSC), Texas Department of Human Services, and the Texas
Department of Mental Health and Mental Retardation. The Commissioner of the
Texas Health and Human Services Commission is required to promulgate uniform
fair hearing rules under the Government Code, Chapter 531.
The department is making the following minor change due to staff comments
to improve the accuracy of the section.
Change: Concerning §1.41(a), the language ", effective March 31, 1999"
was deleted.
No comments were received regarding adoption of the new rule.
The new section is adopted under the Health and Safety Code,
§12.001, which provides the board with the authority to adopt rules for
its procedure and for the performance of each duty imposed by law on the board,
the department, or the commissioner of health.
The new section affects the Health and Safety Code, Chapter 12.
§1.41. Medicaid Uniform Fair Hearing Procedures.
(a)
Authority. The Texas Department of Health (department)
adopts by reference rules regarding Medicaid fair hearings adopted by the
Texas Health and Human Services Commission under 1 Texas Administrative Code
(TAC), Chapter 357, §§357.1, 357.3, 357.5, 357.7, 357.9, 357.11,
357.13, 357.15, 357.17, 357.19, 357.21, 357.23, 357.25, 357.27, and 357.29.
(b)
Scope. These rules establish fair hearing procedures which
the department will follow when the department is required to conduct a fair
hearing for Medicaid funded services.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on June
28, 1999.
TRD-9903848
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 18, 1999
Proposal publication date: April 9, 1999
For further information, please call: (512) 458-7236
Subchapter M. Texas Perinatal Care System
25 TAC §§37.251-37.259
The Texas Department of Health (department) adopts new §§37.251-37.259
concerning the establishment of a voluntary perinatal health care system.
Sections 37.251-37.253 and 37.256-37.259 are adopted with changes to the proposed
text as published in the April 2, 1999, issue of the
Texas Register
(24 TexReg 2595). Sections 37.254 and 37.255 are adopted
without changes, and therefore will not be republished.
These rules implement Health and Safety Code, Chapter 32, Subchapter B,
which requires the Texas Board of Health (board) to adopt minimum standards
and objectives to implement a voluntary perinatal health care system. Specifically,
the sections cover the purpose of the rules; definitions; professional standards/guidelines;
statewide oversight of the perinatal care system and interstate cooperation;
perinatal planning areas (PPAs); perinatal resource coordinating groups (PRCGs);
perinatal plans; data analysis and progress report; and designation of perinatal
care facilities.
The intent of the legislation and these sections is the promotion of safe,
quality, risk-appropriate perinatal care for women and for their infants;
continuity and comprehensiveness of care; optimal and cost-effective utilization
of perinatal personnel and facilities; and the provision of health promotion
and health education for women from preconception through the postpartum period,
as well as parenting information through the first year of their infants'
lives.
The following comments were received concerning the proposed rules. Following
each comment is the department's response and any resulting change(s).
Comment: Concerning the subchapter as a whole, one commenter supported
the overall content, but expressed skepticism that the rules as proposed would
establish effective regulation of certain "for-profit" practices in perinatal
care such as false advertising and selective transports of pregnant women
and neonates. The commenter added that the "medical home" of the woman and/or
neonate should remain financially responsible for transport.
Response: The department acknowledges the commenter's concern about the
overall effectiveness of a voluntary perinatal system. However, the department
believes the rules will enable PRCGs in each of the PPAs to focus on issues
such as those the commenter raises through the perinatal system planning process.
No changes were made as a result of this comment.
Comment: Concerning the subchapter as a whole, one commenter stated that
implementation of the rules will require the department to incur costs through
its regions.
Response: The department agrees. When the 74th Legislature mandated establishment
of the voluntary perinatal health care system, no accompanying legislative
appropriation was provided. Until and if the legislature appropriates funds
to support development of the perinatal health care system, plans for allocating
existing funds within the department must evolve. No changes were made as
a result of this comment.
Comment: Concerning the subchapter as a whole, one commenter stated that
because of the time required for collaboration, reporting, verification of
facility designations, and other activities, local governments, communities,
and facilities will incur costs in implementing the sections on a local level.
The commenter stated that the department should establish the system so that
everyone can participate on a truly "cost-neutral" basis. The commenter also
stated that increasing or improving maternal commitment would most directly
improve pregnancy outcomes in his part of the state.
Response: The legislature directed the department to assist local communities,
facilities, and providers in regions across the state in a collaborative planning
process to support and strengthen local perinatal provider relationships and
referral arrangements in order to improve the quality of the perinatal service
delivery system. Participation in the development of an integrated perinatal
health care system is optional, and if undertaken, will require varying commitments
of time and resources. Such planning might ultimately distribute provider
costs, reimbursements, and responsibility to clients in a more open and equitable
manner. Also, since the planning process for the perinatal health care system
not only allows but encourages participation by consumers and community-based
support service entities, inclusion of these groups should help address issues
such as "maternal commitment". No changes were made as a result of these comments.
Comment: Concerning the subchapter as a whole, one commenter stated that
formation of PRCGs in Public Health Regions 9/10 and 11 might be helpful in
addressing issues concerning funding for prenatal care for the undocumented.
The commenter added the department's Medicaid Managed Care Committee and the
Regional EMS Committees may have suggestions for successful implementation.
Response: The department agrees that the process of establishing a perinatal
health care system across Texas may also help particular areas and communities
find solutions to problems such as funding for perinatal care for undocumented
persons. No changes were made as a result of this comment.
Comment: Concerning §37.251(1), one commenter suggested that addition
of the phrase "risk-appropriate perinatal" would more precisely define the
purpose of the statewide perinatal health care system.
Response: The department agrees and has amended the section by adding the
phrase "risk- appropriate perinatal".
Comment: Concerning §37.252(7), one commenter stated that the definition
of the term "neonate" should be changed to "an infant from birth through 28
completed days after birth" for consistency with the current World Health
Organization definition of "neonatal period".
Response: The department agrees and has amended the definition accordingly.
Comment: Concerning §37.252(15), one commenter stated that the definition
of "subspecialty perinatal facility" should include approximately the same
level of detail as the definitions of "specialty perinatal facility" and "basic
perinatal facility".
Response: The department agrees and has deleted the qualifications required
for physicians who supervise subspeciality perinatal facilities. Specific
designation criteria for basic, specialty, and subspecialty perinatal facilities
are adopted by reference at §37.253 of this title (relating to Professional
Standards/Guidelines).
Comment: Concerning §37.253(a)(1), one commenter stated that some
of the page references from the publication
Guidelines
for Perinatal Care, Fourth Edition
should be amended for accuracy and
also suggested that a new standard/guideline concerning "Risk Assessment and
Management" should be added.
Response: The department agrees and has changed the page numbers and added
the new standard/guideline references.
Comment: Concerning §37.253(a)(2), one commenter suggested that the
section should be amended to add three new standards/guidelines concerning
"Content of Reproductive Health Screening", "Early Pregnancy Risk Identification",
and "Ongoing Pregnancy Risk Identification".
Response: The department agrees and has added the three new subparagraphs.
Comment: Concerning §37.255, one commenter stated that the PPAs are
too large for effective coordination.
Response: The department acknowledges that PRCGs in each of the PPAs will
confront different issues, and that the PRCGs in some PPAs may find it necessary
to create two or more subgroups that can address the needs of specific geographic
areas within the PPA. The perinatal plan for each PPA will reflect its own
needs. No changes were made as a result of this comment.
Comment: Concerning §37.256(a), one commenter stated that the rules
should include specific criteria and/or standards concerning use of helicopters
and fixed-wing aircraft for transport.
Response: The section requires each PRCG to develop a perinatal plan which
includes referral and transport protocols. The PRCGs may consult the health
care literature and seek guidance from health care professionals, department
staff, and other sources to establish standards of practice for transports.
No changes were made as a result of this comment.
Comment: Concerning §37.256(a), one commenter stated that rather than
requiring PRCGs to "establish" perinatal networks, PRCGs should support their
development by the communities in the PPAs.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.256(d), one commenter stated that the subsection
should be amended to allow a broad spectrum of providers to participate in
the PRCGs.
Response: The department agrees and has amended the subsection as suggested.
Comment: Concerning §37.256(g)(5), one commenter suggested that the
section should be amended to clarify that PRCGs should support rather than
impose integration of community resources and planning efforts.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.257, one commenter stated that the section
should be amended to state that PPAs may include one or more perinatal networks,
depending on the area's needs.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.257(c)(4)(B), one commenter suggested adding
the word Aperinatal@ before the word "provider" to clearly define one of the
sources of information and opinion upon which perinatal plans must be based.
Response: The department agrees and has amended the section as suggested.
Comment: Concerning §37.258, maternal deaths should be investigated,
but that information is not included among the information to be provided
by the department to the PRCGs.
Response: Although the "maternal mortality rate" is listed in §37.258(a)(1)(A),
as one of the statistics to be monitored, the section as proposed does not
include information on causes of maternal deaths. Section 37.258(a)(1)(B)(viii)
has been amended accordingly.
Comment: Concerning §37.258(a)(1)(A), one commenter stated that the
descriptive phrase following "postneonatal" should be amended for consistency
with the current World Health Organization definition of the term "neonatal
period".
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.258(b)(4), one commenter suggested adding
the word Aperinatal@ before the word "provider" to emphasize that the annual
report to be filed by each PRCG must document "perinatal provider education".
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.259, one commenter suggested changing the
description of the review teams for basic, specialty, and subspecialty perinatal
facilities to allow inclusion of a group of perinatal providers and one or
more department representatives, if desired.
Response: The department agrees and the section has been amended as requested.
Comment: Concerning §37.259, one commenter stated that self-declaration
of the level of care by facilities presents a problem and that state inspection
should be required.
Response: The department disagrees that mandatory state inspection of perinatal
facilities is necessary to assure accurate designations of level of care.
Section 37.253(a)(1)-(2) lists the designation criteria for levels of inpatient
perinatal care, and the department will publish the self-declared perinatal
center designations. Although §37.259(d) authorizes the department to
conduct site visit reviews at the request of a PRCG or at random, community
knowledge and ownership of the health care issues should prompt facilities
to make accurate level of care designations and to improve and/or expand their
operations if needed. Continuing community pressure and PRCG scrutiny may
be more effective than a site visit by the state once every three years. The
rules set up an infrastructure for service planning and delivery that addresses
the communities' needs and is evaluated on the basis of health care outcomes.
That process will result in heightened attention, visibility, and vigilence
regarding perinatal health care, all of which will make it more difficult
for poor quality health care practices to survive. No changes were made as
a result of this comment.
Comment: Concerning §37.259, one commenter stated that one hospital
in each region should be designated as the perinatal hospital for that region.
Response: The department disagrees. Each PRCG will address the service
delivery and provider patterns in the perinatal plan for the region. The plan
will vary from region to region depending on the resources in the region.
No changes were made as a result of this comment.
Comment: Concerning §37.259(e), one commenter stated that the subspecialty
of "neonatal-perinatal medicine" should be listed before the specialty of
Apediatrics@ in the description of the review team for specialty and subspecialty
perinatal facilities in order to establish a more effective survey process.
Response: This section has been amended in response to another comment
to provide greater flexibility in the composition of facility review teams.
No changes were made as a result of this comment.
The new sections are adopted under Health and Safety Code, §32.042,
which authorizes the Texas Board of Health (board) to adopt rules to implement
a perinatal health care system; and Health and Safety Code, §12.001,
which authorizes the board to adopt rules to implement every duty imposed
by law on the board, the department, and the commissioner of health.
§37.251. Purpose.
The purpose of these sections is to establish the procedures and standards
for the implementation of a statewide system for perinatal health care that
fosters:
(1)
safe, quality, risk-appropriate perinatal care for women
and for their infants;
(2)
continuity and comprehensiveness of care;
(3)
optimal and cost-effective utilization of perinatal
personnel and facilities; and
(4)
access for women to health promotion and health education
from preconception through the postpartum period, and parenting information
through the first year of their infants' lives.
§37.252. Definitions.
The following words and terms pertain explicitly to this subchapter
and shall have the following meanings, unless the context clearly indicates
otherwise.
(1)
Basic perinatal facility - An inpatient facility providing
care during the prenatal period for women and infants whose care is or is
expected to be uncomplicated.
(2)
Department - Texas Department of Health, 1100 West
49th Street, Austin, Texas 78756.
(3)
Health education - Provision of health information
and anticipatory guidance concerning nutrition, fitness, and the prevention
and early recognition of perinatal risk conditions and/or illnesses.
(4)
Health promotion - Provision of information or activities
which motivate individuals to adopt healthy behaviors, including the appropriate
use of health resources.
(5)
Infant - An individual from birth through the first
year of life.
(6)
Intrapartum - The period beginning at the onset of
labor or childbirth and ending with delivery.
(7)
Neonate - An infant from birth through 28 completed
days after birth.
(8)
Parenting information - Information provided to any
person responsible for the care of a child about practices which promote the
child's mental and physical health and quality of life.
(9)
Perinatal - The period which begins before conception
in a woman of child-bearing age and ends on the infant's first birthday.
(10)
Postpartum - The six-week period following delivery.
(11)
Prenatal - The period beginning on the date of conception
and ending with the commencement of labor or childbirth.
(12)
Provider - A person, facility, and/or organized
entity that delivers or affects the delivery of perinatal care.
(13)
Specialty perinatal facility - An inpatient facility
providing care during the prenatal period for women and infants whose care
is or is expected to be uncomplicated as well as for the majority of those
women and infants who are at high risk for or who require complicated care.
(14)
State - The State of Texas.
(15)
Subspecialty perinatal facility - An inpatient facility
providing care during the prenatal period for all pregnant women and infants,
including those with serious illnesses and abnormal health conditions.
§37.253. Professional Standards/Guidelines.
(a)
Activities of the department and providers pursuant to
this subchapter will be conducted in accordance with guidelines and standards
for perinatal care found in the following obstetric and pediatric professional
publications:
(1)
Guidelines for Perinatal Care,
Fourth Edition
(American Academy of Pediatrics, American College of
Obstetricians and Gynecologists, 1997).
(A)
Table 1-1: Ambulatory Prenatal Care Provider Capabilities
and Expertise, page 3;
(B)
Table 1-2: Health Screening for Women of Reproductive
Age, page 10;
(C)
Table 2-1: Recommended Nurse/Patient Ratios for Perinatal
Care Services, page 19;
(D)
Table 4-2: Risk Factors Associated with Spontaneous Preterm
Labor and Birth, page 89;
(E)
Appendix B: Early Pregnancy Risk Identification for Consultation,
pages 299-300;
(F)
Appendix C: Ongoing Pregnancy Risk Identification for
Consultation, pages 301-302;
(G)
Appendix D: Federal Requirements for Patient Screening
and Transfer, pages 303-309;
(H)
In-Hospital Perinatal Care, pages 4-7;
(I)
Inpatient Perinatal Care Services, pages 13-50;
(J)
Interhospital Care of the Perinatal Patient, pages 51-61;
(K)
Patient Education, pages 68-70;
(L)
Risk Assessment and Management, page 76;
(M)
Intrapartum Care, pages 91-125; and
(2)
Toward Improving The
Outcomes of Pregnancy, The 90s and Beyond
(March of Dimes, American
Academy of Pediatrics, and American College of Obstetricians and Gynecologists,
1993);
(A)
Table 1: Content of Reproductive Health Screening, page
15;
(B)
Appendix 4a: Early Pregnancy Risk Identification, page
96;
(C)
Appendix 4b: Ongoing Pregnancy Risk Identification, page
97;
(D)
Appendix 6: Levels of Inpatient Perinatal Care, pages
102-115.
(b)
Copies of these publications may be viewed during normal
business hours at the Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756-3199 or they may be obtained from the American Academy of Pediatrics,
the American College of Obstetricians and Gynecologists, or the March of Dimes
publications office. Contact numbers for these organizations are available
from the department at the address in this subsection.
§37.254. Statewide Oversight of the Perinatal Care System and Interstate Cooperation.
(a)
The department shall develop and maintain a reporting
and analysis system to monitor outcomes of the statewide perinatal care system.
(b)
The department shall request information as specific issues
arise from persons with expertise in the provision of perinatal care, data
analysis, and community networking/systems development, including, but not
limited to, individuals from academic institutions, professional groups, advocacy
groups, and other state agencies. The department shall also seek ongoing input
from consumers or recipients of perinatal care and from representatives of
their identified community-based social support systems (e.g. extended families,
churches).
(c)
The department shall facilitate the organization and operations
of the perinatal resource coordinating groups described in §37.256 of
this title (relating to Perinatal Resource Coordinating Groups).
(d)
The department shall facilitate cooperation and coordination
with perinatal care providers and systems in adjoining states.
§37.255. Perinatal Planning Areas.
(a)
Eight perinatal planning areas (PPAs), encompassing every
county in the state, shall be established for descriptive, planning, and continuous
quality improvement purposes. The PPA boundaries shall be based upon the regional
organization of the Texas Health and Human Services Commission (HHSC).
(b)
PPA boundaries are not intended to restrict decisions
concerning client referral or transfer to other facilities or providers.
(c)
The perinatal planning areas shall include the following
counties:
(1)
Area One (HHSC Region 1): Armstrong, Bailey, Briscoe,
Carson, Castro, Childress, Cochran, Collingsworth, Crosby, Dallam, Deaf Smith,
Dickens, Donley, Floyd, Garza, Gray, Hale, Hall, Hansford, Hartley, Hemphill,
Hockley, Hutchinson, King, Lamb, Lipscomb, Lubbock, Lynn, Moore, Motley, Ochiltree,
Oldham, Parmer, Potter, Randall, Roberts, Sherman, Swisher, Terry, Wheeler,
and Yoakum;
(2)
Area Two (HHSC Region 2/3): Archer, Baylor, Brown,
Callahan, Clay, Coleman, Collin, Comanche, Cooke, Cottle, Dallas, Denton,
Eastland, Ellis, Erath, Fannin, Fisher, Foard, Grayson, Hardeman, Haskell,
Hood, Hunt, Jack, Johnson, Jones, Kaufman, Kent, Knox, Mitchell, Montague,
Navarro, Nolan, Palo Pinto, Parker, Rockwall, Runnels, Scurry, Shackelford,
Somervell, Stephens, Stonewall, Tarrant, Taylor, Throckmorton, Wichita, Wilbarger,
Wise, and Young;
(3)
Area Three (HHSC Region 4/5): Anderson, Angelina,
Bowie, Camp, Cass, Cherokee, Delta, Franklin, Gregg, Harrison, Henderson,
Hopkins, Houston, Jasper, Lamar, Marion, Morris, Nacogdoches, Newton, Panola,
Polk, Rains, Red River, Rusk, Sabine, San Augustine, San Jacinto, Shelby,
Smith, Titus, Trinity, Tyler, Upshur, Van Zandt, and Wood;
(4)
Area Four (HHSC Region 6/5): Austin, Brazoria, Chambers,
Colorado, Fort Bend, Galveston, Hardin, Harris, Jefferson, Liberty, Matagorda,
Montgomery, Orange, Walker, Waller, and Wharton;
(5)
Area Five (HHSC Region 7): Blanco, Bosque, Brazos,
Burleson, Burnet, Caldwell, Coryell, Falls, Fayette, Freestone, Grimes, Hamilton,
Hays, Hill, Lampasas, Lee, Leon, Limestone, Llano, McLennan, Madison, Milam,
Mills, Robertson, San Saba, Travis, Washington, and Williamson;
(6)
Area Six (HHSC Region 8): Atascosa, Bandera, Bexar,
Calhoun, Comal, De Witt, Dimmit, Edwards, Frio, Gillespie, Goliad, Gonzales,
Guadalupe, Jackson, Karnes, Kendall, Kerr, Kinney, La Salle, Lavaca, Maverick,
Medina, Real, Uvalde, Val Verde, Victoria, Wilson, and Zavala;
(7)
Area Seven (HHSC Region 9/10): Andrews, Borden, Brewster,
Coke, Concho, Crane, Crockett, Culberson, Dawson, Ector, El Paso, Gaines,
Glasscock, Howard, Hudspeth, Irion, Jeff Davis, Kimble, Loving, McCulloch,
Martin, Mason, Menard, Midland, Pecos, Presidio, Reagan, Reeves, Schleicher,
Sterling, Sutton, Terrell, Tom Green, Upton, Ward, and Winkler; and
(8)
Area Eight (HHSC Region 11): Aransas, Bee, Brooks,
Cameron, Duval, Hidalgo, Jim Hogg, Jim Wells, Kenedy, Kleberg, Live Oak, McMullen,
Nueces, Refugio, San Patricio, Starr, Webb, Willacy, and Zapata.
§37.256. Perinatal Resource Coordinating Groups.
(a)
A perinatal resource coordinating group (PRCG) shall be
established within each perinatal planning area (PPA) to examine outcomes,
to develop community-based plans for continuous improvement of perinatal care
services, to work with communities in order to foster perinatal networks,
and to develop at-risk and emergency transfer/transport protocols, considering
the standards/guidelines listed in §37.253 of this title (relating to
Professional Standards/Guidelines).
(b)
A PRCG shall be established in each PPA within five years
from the date this subchapter becomes effective.
(c)
PRCG members shall be initially recruited by the following
department staff:
(1)
the Regional Medical Director or designee from the region
in which most of the counties in the PPA are located;
(2)
a representative of the Emergency Medical Services
Division; and
(3)
representatives from the Medicaid and maternal and
child health programs.
(d)
PRCG membership shall include broad-based community representation
from the counties in the PPA; perinatal providers, including basic, specialty,
and subspecialty perinatal care facilities; advocacy groups; consumers; social
support systems; and primary care residency programs. PRCG membership shall
reflect the demographics of the population.
(e)
Each PRCG shall adopt bylaws describing the purpose; membership
and member terms; officers and their terms of office; and periodicity of meetings.
(f)
The department shall provide data and technical assistance
to the PRCGs.
(g)
Each PRCG shall be charged with:
(1)
analyzing perinatal data, including, but not limited to
the following:
(A)
reports provided by the department concerning the perinatal
vital statistics in the PPA; and
(B)
aggregated reports of problems identified by the maternal,
neonatal, and infant mortality review committees of each participating facility
and by communities in the PPA;
(2)
responding to consumer and/or provider complaints
that pertain to perinatal care and that have been directed to the PRCG;
(3)
responding to complaints that pertain to perinatal
care originally received by the Texas Department of Insurance and/or the department;
(4)
identifying and supporting health care delivery systems
and social support infrastructures within the communities of the PPA that
enhance the quality of perinatal health care;
(5)
providing technical assistance to communities to
enhance coordination of perinatal service planning and delivery among perinatal
network providers (including perinatal transport providers), consumers, and
community-based support entities within the PPA;
(6)
identifying unmet community needs, such as gaps in
perinatal care or breakdowns in communications; and
(7)
developing a community-based perinatal plan to coordinate
existing services and address unmet needs that builds upon and bolsters community
strengths, health care delivery systems, and social support infrastructures.
The plan will address community-based, culturally competent health promotion
activities, both consumer and provider health education, the development and
support of perinatal networks, and referral/transport protocols for high-risk
pregnant women and newborn infants.
§37.257. Perinatal Plans.
(a)
The perinatal resource coordinating group (PRCG) in each
perinatal planning area (PPA) shall submit for approval to the department
an initial perinatal plan concerning the provision of perinatal care for women
of child-bearing age and infants within the PPA. The plan shall be submitted
in a format specified by the department.
(b)
Each PRCG shall submit an annual revised plan in a format
specified by the department.
(c)
The initial plan and any revisions shall be subject to
approval by the department, contingent upon documentation of the following:
(1)
individuals representing the geographic and demographic
diversity of all counties within the PPA have been involved in the development
and implementation of the plan;
(2)
individuals representing all perinatal care facilities
have been given an opportunity to participate in the planning and implementation
process, through participation in either the PRCG or the perinatal network(s);
(3)
mechanisms are in place for communication and coordination
of services among the PPA perinatal network(s);
(4)
the plan includes:
(A)
a list of participants in the PRCG and the perinatal network(s);
(B)
a list of identified strengths and unmet needs of the
PPA based on analysis of the PPA data, registered complaints, and discussions
with consumers, community-based support entities, and perinatal providers;
(C)
a list of goals and objectives to improve the quality
of perinatal care based upon the identified strengths and unmet needs in the
PPA and the health outcomes measures referenced in §37.258 of this title
(relating to Data Analysis and Progress Report);
(D)
mechanisms for completing referrals and returning reports
of care provided among the perinatal care providers;
(E)
protocols for exchange of confidential patient records
among participating providers in the perinatal planning area;
(F)
descriptions of emergency transport capability requirements
and protocols;
(G)
protocols for at-risk and emergency maternal and neonatal
transfer from one hospital to another for the purpose of receiving more intensive
or specialized care;
(H)
protocols for return transfer of a pregnant woman and/or
her infant from a referral center to the original referring hospital or to
a local hospital for continuing care;
(I)
triage criteria for appropriate level referrals; and
(J)
mechanisms and protocols for:
(i)
conducting high-risk screening and counseling guidance;
(ii)
increasing community awareness of the existence of the
perinatal plan(s) and the importance of early and preventive care for women
of child-bearing age and infants;
(iii)
increasing consumer access to the perinatal network(s);
(iv)
continuing improvement of the quality of perinatal care;
and
(v)
community-based and area-wide perinatal health education,
health promotion, and dissemination of parenting information.
§37.258. Data Analysis and Progress Report.
(a)
Annually the department shall provide each perinatal resource
coordinating group (PRCG) with:
(1)
information pertaining to the population of women of child-bearing
age and infants within its perinatal planning area (PPA), including:
(A)
neonatal mortality rate, postneonatal (beginning after
28 completed days after birth and extending through one completed year of
life) mortality rate, infant mortality rate, and maternal mortality rate;
(B)
information collated from birth and death certificates,
including but not limited to:
(i)
trimester of entry into prenatal care;
(ii)
number of prenatal visits related to time of entry into
prenatal care;
(iii)
maternal use of tobacco, drugs, and alcohol;
(iv)
number of low birth weight infants;
(v)
number of pre-term infants;
(vi)
numbers and rates of low birth weight and very low birth
weight infants by facility of birth;
(vii)
causes of infant deaths;
(viii)
causes of maternal deaths;
(ix)
maternal transports and infant transports; and
(C)
other information available from state reported data and
registries upon request of the PRCG; and
(2)
information recorded by the department pertaining
to the perinatal care facilities within the PPA, including licensure status
and level designation as perinatal center.
(b)
Each PRCG shall file an annual report in a format approved
by the department describing its activities and progress toward outcome objectives
projected in the plan or in the revised plan, as described in §37.257
of this title (relating to Perinatal Plans). The report shall include:
(1)
evidence that the members of the PRCG and perinatal networks
are involved in evaluation and management of the plan;
(2)
changes in the membership of the PRCG;
(3)
documentation of community-based consumer education,
including topics concerning prevention of health risks; the importance of
early and regular preventive health check-ups; and access to the perinatal
care systems;
(4)
documentation of perinatal provider education concerning
the availability of high risk screening tools, patient counseling, referral
protocols, and population-based health needs assessment; and
(5)
documentation of progress toward the goals and objectives
stated in their plan.
(c)
The department shall maintain the confidentiality of all
information in these reports to the extent authorized by the Texas Open Records
Act, Government Code, Chapter 552.
§37.259. Designation of Perinatal Care Facilities.
(a)
The department or its designee(s) shall request inpatient
facilities to report to the department their self-designations as basic, specialty,
or subspecialty perinatal care facilities. Designations shall be self-reported
by facilities based upon the standards and guidelines in the publications
listed in §37.253 of this title (relating to Professional Standards/Guidelines).
Facilities shall select the designation category that most accurately describes
their capacity to provide perinatal care.
(b)
Each facility providing inpatient perinatal care may voluntarily
report to the department its self-designated category.
(c)
The department shall publish the designation categories
of all participating perinatal facilities in each perinatal planning area
annually.
(d)
The department or its designees may evaluate a facility
to confirm the facility's self- declared designation category through a random
review process or upon request by a perinatal resource coordinating group
(PRCG), at the discretion of the department.
(e)
The review team for specialty and subspecialty perinatal
facilities may include board certified/eligible specialists in obstetrics,
maternal-fetal medicine, pediatrics, and neonatal-perinatal medicine, as appropriate
for the facility to be reviewed, and one or more department representatives.
(f)
The review team for basic perinatal facilities may include
one or more active perinatal care providers and one or more department representatives.
(g)
The department shall provide a copy of the review report
and recommendations to the reviewed facility, the review team, and the PRCG.
(h)
Whenever a facility review is conducted, the department
may confirm the self-declared designation or approve a different designation.
(i)
If a perinatal care facility disagrees with the department's
designation decision, the facility may request an administrative hearing which
shall be conducted according to §§1.51-1.55 of this title (relating
to Fair Hearing Procedures).
(j)
A participating perinatal care facility shall notify the
department and its PRCG within 30 days if it is unable or chooses not to continue
providing perinatal care commensurate with its designation category.
This agency hereby certifies that the adoption has been reviewed
by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on June
28, 1999.
TRD-9903847
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: July 18, 1999
Proposal publication date: April 2, 1999
For further information, please call: (512) 458-7236
Subchapter M. Regulation of Food, Drug, Device, and Cosmetic Salvage Establishments and Brokers
Chapter 37.
Maternal and Infant Health Services
Chapter 229.
Food and Drug