Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 1.
TEXAS BOARD OF HEALTH
Subchapter A. PROCEDURES AND POLICIES
The Texas Department of Health (department) adopts the repeal of §1.2
and amendments to §1.1, and §§1.3-1.8 concerning procedures
and policies of the Board of Health (board). Section 1.6 and §1.7 are
adopted with changes to the proposal published in the January 28, 2000, issue
of the
Texas Register
(25 TexReg 496). Sections
1.1-1.5 and 1.8 are adopted without changes and therefore will not be republished.
Specifically the sections address the purpose of the sections, organization
of the board, powers and duties of the board, meetings of the board, actions
requiring board approval, the commissioner of health, and press and public
relations. The repeal of the section on membership of the board is adopted
in order to delete language which is redundant of state law.
Government Code, §2001.039 requires each state agency to review and
consider for readoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedure Act). Sections 1.1 - 1.8 have
been reviewed and the department has determined that the reasons for adopting
these sections, other than §1.2 on membership of the board, continue
to exist; however, the language of the sections should be updated and language
that is redundant of state law should be deleted. The language is redundant
of state law found in the Health and Safety Code, Chapters 11 and 12 relating
to appointments of the chair and vice-chair of the board, advisory committees
appointed by the board, meetings of the board, and reimbursement of expenses
of board members; Open Meetings Act, Texas Government Code, Chapter 551 relating
to meetings of governmental bodies; and Texas Civil Statutes, Article 6252-31
relating to dissenting votes in board meetings. In addition to clarifying
language throughout the sections, §§1.4, 1.6, and 1.7 are amended
to conform with House Bill 2641, enacted by the 76th Legislature. This law
establishes new relationships among the Health and Human Services Commission,
the Board of Health, and the Commissioner of Health (commissioner). Section
1.5(e) is added to state that time limits may be established for public comments
or testimony at board and committee meetings.
The department published a Notice of Intention to Review the sections in
the
Texas Register
(23 TexReg 9075) on September
4, 1998. No comments were received by the department on these sections.
No comments were received on the proposal during the comment period; however,
the department is making the following changes.
Change: Concerning §1.6, language was added to address the approval
by the board of assistant commissioners.
Changes: Concerning §1.7(b)(2), language was added to expressly authorize
the commissioner to designate one or more employees of the department to approve
expenditure vouchers of the department. The Government Code and the rules
of the Comptroller of Public Accounts authorize a governing body of an agency
to authorize its executive director to designate employees to approve vouchers.
Inclusion of this language constitutes the board's approval for the commissioner
to designate employees. Subsection (c) is added to provide further explanation
concerning the vouchers.
25 TAC §§1.1, 1.3 - 1.8
The amendments are adopted under the Health and Safety Code,
Chapters 11 and 12 which allow the board to adopt rules relating to advisory
committees and board meetings and §12.001 which provides the board with
the authority to adopt rules for its procedures and for the performance of
each duty imposed by law on the board, the department, and the commissioner
of health.
§1.6.Actions Requiring Board Approval.
(a)
Strategic plan. The strategic plan is subject to approval
by the Board of Health.
(b)
Appropriation request. The department's appropriation request
and annual operating budget are subject to approval by the board prior to
submission to the legislature.
(c)
Rules. The board shall adopt rules for its own procedure
and for the performance of each duty imposed by law on the board, the department,
and the commissioner.
(d)
Appointment of the director of the Internal Audit Division.
The appointment or removal of the director of the Internal Audit Division
by the commissioner is subject to approval by the board.
(e)
Of those appointments made by or coordinated with the commissioner,
the following shall be subject to the approval of the board:
(1)
the executive deputy and deputy commissioners of the department;
(2)
the associate commissioners of the department;
(3)
the assistant commissioners of the department;
(4)
the regional directors of the department;
(5)
the director of the Texas Center for Infectious Disease;
and
(6)
the director of the South Texas Hospital.
(f)
Contracts. The chair of the board shall appoint a subcommittee
of no more than three members to review contract activities to which the department
is a party, involving payment greater than $1 million. The subcommittee shall
report major contract activity to the board on a quarterly basis.
(g)
Other actions. The board may approve any other action by
the commissioner or the department where the approval of the board is required
by law, delegated by the commissioner of the Health and Human Services Commission,
or requested by the commissioner.
§1.7.Commissioner of Health.
(a)
The powers and duties of the commissioner of health under
this section are subject to the authority of the Health and Human Services
Commission (commission) under Government Code, Chapter 531 and the memorandum
of understanding between the commissioner of health and the commissioner of
the Health and Human Services Commission. The commissioner of health, as the
executive director of the Texas Department of Health (department), shall perform
the duties delegated and assigned by the Board of Health (board), the commissioner
of the Health and Human Services Commission, and state law.
(b)
The commissioner of health shall:
(1)
administer and enforce federal and state health laws applicable
to the department by issuing orders, making decisions, awarding and executing
contracts, and implementing the duties delegated or assigned to the commissioner
of health by the board and the commissioner of the Health and Human Services
Commission;
(2)
administer and implement department services, programs,
and activities, maintain professional standards within the department, and
represent the department as its chief executive. To accomplish this goal,
the commissioner of health is authorized to hire and supervise personnel,
establish appropriate organization, acquire suitable administrative, clinical,
and laboratory facilities, obtain sufficient financial support, provide for
the operation of the department, designate one or more employees of the department
to sign and approve expenditure vouchers of the department, and further delegate
to departmental personnel duties delegated or assigned by the board and the
commissioner of the Health and Human Services Commission;
(3)
hire and supervise all personnel subject to §1.6(e)
of this title;
(4)
execute all contracts to which the department is a party
involving payment greater than $1 million. This duty may not be delegated;
and
(5)
provide information to the board's subcommittee on contracts
concerning contracting activities anticipated to be for payment greater than
$1 million, including requests for proposals, invitations for bid, and other
procurement activities.
(c)
Expenditure vouchers under subsection (b)(2) of this section
include Uniform Statewide Accounting System (USAS) payment documents, USAS
payroll documents, Uniform Statewide Purchasing System (USPS) payroll documents,
and vouchers submitted to the Comptroller of Public Accounts on paper. All
employees who are properly designated and listed on the department's voucher
signature cards have the authority to approve each payment voucher type.
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 July 27, 2000.
TRD-200005193
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
25 TAC §1.2
The repeal is adopted under the Health and Safety Code, Chapters
11 and 12 which allow the board to adopt rules relating to advisory committees
and board meetings and §12.001 which provides the board with the authority
to adopt rules for its procedures and for the performance of each duty imposed
by law on the board, the department, and the commissioner of health.
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 July 27, 2000.
TRD-200005192
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: January 28, 2000
For further information, please call: (512) 458-7236
Subchapter T. SCHOOL-BASED HEALTH CENTERS
25 TAC §§37.531 - 37.538
The Texas Department of Health (department) adopts new §§37.531
- 37.538 concerning school-based health centers. Sections 37.532, 37.537,
and 37.538 are adopted with changes to the proposed text as published in the
June 9, 2000, issue of the
Texas Register
(25 TexReg 5550). Section 37.531 and §§37.533 - 37.536 are adopted
without change, and therefore will not be republished.
The new sections implement House Bill 2202, Acts 1999, 76th Legislature, §1,
which added Education Code, §§38.0095, 38.011, and 38.012. This
legislation requires the Texas Board of Health (board) to adopt rules to establish
procedures for awarding grants to assist school districts with the costs of
operating school-based health centers, and to establish standards for health
care centers supported by such grants. Adoption of these sections will assure
that grants to support school-based health centers will be awarded fairly
and consistently and that the goals which funded health centers strive to
attain also are consistent with department policy. Specifically, the sections
cover the purpose of the rules; definitions; number of awards; dollar amount
of awards; matching funds; competitive process, guidelines for requests for
proposals; and standards for school-based health centers.
The sections include changes made in response to comments, with the objective
of increasing flexibility during implementation of the program in a manner
consistent with the intent of the legislation. Particular concerns and suggestions
by stakeholders included such issues as reproductive services, program protocols,
funding sources, and the number and location of funded school-based health
centers.
The department is making the following minor changes to clarify the intent
and improve the accuracy of the sections.
Change: Concerning new §37.532(8), a definition of "parent" has been
added to avoid the necessity of repeating the phrase "parent, guardian, or
other person having legal control of the student" in several sections. Paragraphs
(8) and (9) as proposed have been renumbered.
Change: Concerning §37.538(2)(i), the phrase "or guardian" has been
deleted because it is included in the definition of "parent" added at §37.532(8).
Change: Concerning §37.538(2)(ii), the phrase "or guardian" has been
deleted because it is included in the definition of "parent" added at §37.532(8).
Change: Concerning §37.538(2)(E)(v), the phrase "guardian, or other
person having legal control of the student" has been deleted because it is
included in the definition of "parent" added at §37.532(8).
Change: Concerning §37.538(2)(E)(v), the department has clarified
the reference to "consent" by adding that "informed consent" is required for
some procedures or services involving risks or hazards to the student, for
the protection of the school district, the provider, as well as the student.
Change: Concerning §37.538(2)(E)(viii), the phrase "concerning the
clinical treatment" has been added to clarify that coordination by the staff
of the school-based health center staff with a student's primary care physician
includes a clinical component which impacts the quality of care provided,
as well as the necessity to obtain prior authorization for services in order
to seek reimbursement from third-party payors.
Change: Concerning §37.538(2)(E)(xi), a new clause has been added
to clarify that school-based health centers must maintain documentation of
their efforts, required by other sections of the rules, to involve the student's
parent in identification of the student's health-related concerns as well
as notification of the student's parent of scheduled appointments and proposed
services, coordination with the student's primary care physician, and consent
for services by the student's parent, including informed consent when required
for specific services.
The following comments concerning the proposed rules were received during
the public comment period. Following each comment is the department's response
and any resulting change(s).
Comment: Concerning the subchapter as a whole, one commenter stated that
the department should award grant funds only to those school-based health
centers that plan to provide comprehensive services to children.
Response: Education Code, §38.011 requires that school districts,
with assistance from their local health care advisory councils, assess the
need for school-based health centers, and then determine the types of services
to be provided. The department will evaluate those decisions as part of an
applicant's proposal for funding, but has chosen not to require the provision
of specific "comprehensive health care services". No changes were made as
a result of this comment.
Comment: Concerning the subchapter as a whole, one commenter stated that
the department should require school districts to collaborate with health
care agencies in order to receive funds.
Response: Education Code, §38.011(h) authorizes but does not require
a school district to collaborate with public health agencies in the community,
and §38.011(b) authorizes a school district to contract with persons,
to provide services at a school-based health center. The department strongly
encourages local school districts to collaborate with any providers of health
care services in their communities, including individual persons. No changes
were made as a result of this comment.
Comment: Concerning the subchapter as a whole, one commenter stated that
the department should fund at least one school-based health center in each
of the major cities in Texas with an equal number being funded in heavily
populated urban areas, moderate sized cities, and rural areas.
Response: Education Code, §38.011(p) requires that grants be awarded
annually on a competitive basis and that school districts located in rural
areas or that have low property wealth per student must be given preference
in funding decisions. No changes were made as a result of this comment.
Comment: Concerning the subchapter as a whole, one commenter suggested
that the department should require funded applicants to participate in the
Texas Association of School- Based Health Care as well as the National Assembly
For School-Based Health Care.
Response: The department disagrees. While the department supports participation
by school districts in professional organizations, requiring such activities
by rule exceeds the scope of the Legislature's mandate. No changes were made
as a result of this comment.
Comment: Concerning §37.533, several commenters requested that the
department fund more than two grant applications per year.
Response: The department's legislative appropriation for school health
activities during the current biennium is finite. The department agrees that
the mandate from the Legislature to fund at least two school-based health
center contracts per year is a minimum standard rather than a maximum limit.
No changes were made as a result of this comment.
Comment: Concerning §37.533, commenters requested that the department
continue to fund established school-based health centers as well as applicants
for new grants.
Response: The department interprets references at Education Code §38.011(b)
and (h) to apply to school districts which seek assistance with the initial
establishment of a school-based health center, subject to availability of
federal or state appropriated funds. No changes were made as a result of this
comment.
Comment: Concerning §37.537(5), one commenter recommended that the
department should evaluate applicants' proposals on the basis of their "stated
willingness" as well as their ability to comply with the standards for school-based
health centers.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.538, one commenter suggested that the following
language should be added as a new paragraph (5). "Compliance. A funded applicant
shall be subject to audit by the department in order to ensure that all department
requirements are being met. A funded applicant must also provide the following:
(A) An annual written report detailing the methods by which the funded applicant
has met department requirements; and (B) A statement signed by a representative
of the school district that states that the district has made a good faith
effort to meet all requirements of the department."
Response: The department agrees that a funded applicant will be obligated
by rule and its contract to expend grant funds only as described in its application.
Section 37.538(4)(B)(iv) requires funded applicants to produce an annual report
with data evaluating the effectiveness of the school-based health center,
including its impact on student attendance and performance. Since the annual
report already required should enable the department to determine if a funded
applicant is complying with program standards, mandating an additional report
as suggested appears unnecessary. The department has added a new paragraph §37.538(5)
requiring annual assurances by representatives of funded applicants of their
good faith efforts to meet all department requirements.
Comment: Concerning §37.538(1), one commenter recommended that the
paragraph be amended to clarify that school-based health centers must comply
with "all" strategies listed for facilitating community-based solutions.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.538(1)(D), one commentor recommended that
funded applicants should "require" rather than "encourage" parental involvement,
including accompaniment of the child and attendance at school-based health
center appointments.
Response: The department agrees that funded applicants should require parental
involvement in the health care services their children receive at and through
school-based health centers and has amended the section accordingly. However,
requiring parental accompaniment would mean some children whose parent(s)
are interested and wish to be involved would be denied services at school-based
health centers if their parent(s) could not accompany them. The department
will continue to "encourage" parental accompaniment of their children when
receiving services at school-based health centers and attendance at appointments.
Comment: Concerning §37.538(1)(D), one commentor recommended that
parental accompaniment be encouraged for any child younger than 18 years of
age.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.538(2)(E)(i), one commentor recommended adding
the words "or other person having legal control of the student".
Response: The department has added a definition of "parent" at §37.532(8),
which includes the word "guardian" as well as the phrase "or other person
having legal control of the student" when used in this subchapter. No changes
were made as a result of this comment.
Comment: Concerning §37.538(2)(E)(iii), one commenter suggested that
"reproductive services" should be defined as "family planning services" is
defined at 25 Texas Administrative Code (TAC) §56.102, but added that
referrals for treatment of sexually transmitted diseases or prenatal care
would not be excluded by such an amendment.
Response: The department agrees and has added new §37.532(9). The
department agrees that treatment for sexually transmitted diseases and prenatal
care is not within the scope of "reproductive services" as defined at 25 TAC §56.102.
No changes were necessary to clarify the ability of school-based health centers
to provide referrals for sexually transmitted diseases or prenatal care.
Comment: Concerning §37.538(2)(E)(iii), several commenters stated
that school-based health centers receiving grant funds should be prohibited
from providing reproductive services, counseling, or referrals even if the
services are paid for with other nongrant funds.
Response: The department agrees and has amended the section accordingly.
Comment: Concerning §37.538(2)(E)(iii), several commenters stated
that school-based health centers should not provide contraceptives, abortions,
and/or referrals to Planned Parenthood.
Response: By law, school-based health centers may not provide reproductive
services, as defined at §37.532(8). No changes were made as a result
of this comment.
Comment: Concerning §37.538(2)(E)(v), one commenter requested that
the phrase "for each treatment occasion" be added.
Response: The department has added the phrase, including clarification
that a student's parent may provide specific written consent for more than
one treatment occasion at once. The department also has deleted the definition
of "treatment occasion" which was proposed as §37.532(10) because it
is inconsistent with the Legislature's intent, stated at Education Code, §38.011(f).
Comment: Concerning §37.538(2)(E)(viii), one commenter suggested that
coordination with the person's primary physician before delivering a service
should include "obtaining an authorization form" from the physician.
Response: The department agrees that school-based health centers must obtain
authorization prior to delivery of services if a student has a primary care
physician under Medicaid or another health plan in order to seek reimbursement
and has amended the section accordingly.
Comment: Concerning §37.538(3)(A)-(E), one commenter stated that the
referenced population-based strategies are too vague, and that the department
should adopt and implement protocols.
Response: The department believes these more general strategies rather
than specific protocols will allow community-based programs to address their
unique needs in culturally appropriate ways in line with current practice
patterns in their own regions of the state. No changes were made as a result
of this comment.
The following commenters were generally in favor of the rules, but had
concerns, questions, and/or suggestions for change: Representative Arlene
Wohlgemuth; Citizens for Excellence in Education; Global Maintenance Services,
Inc.; and Campus Care Centers, Brownsville, Texas.
The following commenter had questions and suggestions for change, but was
neither for nor against the rules in their entirety: Hays Consolidated Independent
School District.
The new sections are adopted under Education Code, §38.011(n),
which requires the commissioner of health to adopt rules to establish procedures
for awarding grants in accordance with the section; Education Code, §38.011(q),
which requires the commissioner of health to adopt rules establishing standards
for health care centers funded through said grants; and Health and Safety
Code, §12.001, which authorizes the Texas Board of Health (board) 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.
§37.532.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise:
(1)
Applicant--A school district applying for a grant from
the Texas Department of Health to assist with the costs of operating a school-based
health center.
(2)
Conventional health services--Family and home support;
health care, including immunizations; dental health care; health education;
and preventive health strategies.
(3)
Department--The Texas Department of Health.
(4)
Funded applicant--A school district that applies for a
grant from the Texas Department of Health to assist with the costs of operating
a school-based health center and with which the Texas Department of Health
subsequently executes a contract to operate a school-based health center.
(5)
Grant--A sum of money awarded to a selected applicant on
the basis of a Request for Proposals that results in a contract.
(6)
Local health education and health care advisory council--Persons
appointed by the board of trustees of a school district to make recommendations
to the district concerning the establishment of school-based health centers
and to assist the district in ensuring that local community values are reflected
in the operation of each center. In addition to the majority of appointees
who shall be parents of students, the board of trustees shall also appoint
at least one person from each of the following groups:
(A)
teachers;
(B)
school administrators;
(C)
licensed health care professionals;
(D)
the clergy;
(E)
law enforcement;
(F)
the business community;
(G)
senior citizens; and
(H)
students.
(7)
Low property wealth per student--An assessed valuation
per student in the applicant school district of no more than 25% of the state
average assessed valuation per student.
(8)
Parent--The mother, a man presumed to be the biological
father, a man legally determined to be the biological father, a man who has
been adjudicated to be the biological father by a court of competent jurisdiction,
an adoptive mother or father, a guardian, or other person having legal control
of the student.
(9)
Reproductive services--Family planning services as defined
by §56.102 of this title (relating to Definitions).
(10)
Rural area--A county with a population of not greater
than 50,000, or an area that has been designated under state or federal law
as:
(A)
a health professional shortage area;
(B)
a medically underserved area; or
(C)
a medically underserved community as defined by the Center
for Rural Health Initiatives.
(11)
School-based health center--An entity established by a
school district or by a school district jointly with a public health agency
at one or more campuses in the school district to deliver cooperative health
care programs, prevention of emerging health threats that are specific to
the district, and conventional health services for students and their families.
§37.537.Guidelines for Requests for Proposals.
The department shall complete one Request for Proposals (RFP) process
for school-based health centers per state fiscal year according to the following
guidelines.
(1)
Proposals submitted in response to the RFP for school-based
health centers shall be screened, reviewed, and evaluated according to a competitive
process described in full in the RFP.
(2)
The department's School Health Program shall utilize a
standard evaluation instrument for scoring applicants' proposals. A copy of
the instrument shall be included in the RFP.
(3)
A primary review of all applicants' proposals shall be
performed by a member of the School Health Program staff. The reviewer shall
award the same number of bonus points to each applicant located in a rural
area and/or that has low property wealth per student.
(4)
The School Health Program shall select and train evaluators
to score proposals after primary review.
(5)
Proposals shall be evaluated based on the applicant's ability
and stated willingness to comply with the department's standards for school-based
health centers described in §37.538 of this title (relating to Standards
for School-Based Health Centers).
§37.538.Standards for School-Based Health Centers.
Funded applicants shall comply with the following standards for school-based
health care centers.
(1)
Community-based solutions. The funded applicant shall facilitate
collaboration among families, schools, and members of the community to assess
and meet the health needs of the community's children and families. The funded
applicant shall utilize all the following strategies for facilitating community-based
solutions:
(A)
Establish a local health education and health care advisory
council to make recommendations to the district on the establishment of school-based
health centers and to assist the district in ensuring that local community
values are reflected in the operation of each center and in the provision
of health education.
(B)
Establish and/or enhance links between school personnel,
school-based health center personnel, other health/social services providers
and agencies in the community, and other supportive community sectors.
(C)
Enable students and families to be responsible decision-makers
in promoting their own health and well-being, making connections with community
systems that help to prevent the social isolation and alienation of individuals
and families, and using the health care system wisely.
(D)
Require parental involvement in and management of the health
care of children receiving services from the center; encourage parental accompaniment
of any child younger than 18 years of age at visits to the center; notify
the child's parent in writing at least one week in advance of the scheduled
appointment; and encourage the parent to attend the appointment.
(2)
Administration. The funded applicant shall plan and administer
a school-based health center that meets the health needs of the community's
children and families by use of the following strategies:
(A)
Deliver primary and preventive health services to children
and families in a school-based setting.
(B)
Establish efficient, client-friendly procedures for utilizing
all available sources of funding to compensate the district for services provided
by the school-based health center, including money available under the state
Medicaid program, a state children's health plan program, private health insurance
or health benefit plans, and the ability of those using a school-based health
center to pay for the services.
(C)
Contract for provision of services at the school-based
health center if necessary and appropriate.
(D)
Develop and present a specific, detailed plan for future
funding of the school-based health center that demonstrates how the center
will continue to operate when grant funding is no longer available.
(E)
Research, develop, and implement the forms and administrative
procedures necessary to remain in compliance with all applicable and relevant
legislation and regulations. Required procedures contained in applicable legislation
for operation of school-based health centers include but are not limited to
the following:
(i)
provision of services to a student only if the school district
or the provider with whom the district contracts has obtained written consent
to the services from the student's parent within the one-year period preceding
the date on which the services are provided, and the consent has not been
revoked;
(ii)
joint identification by school-based health center staff
and the student's parent of any health-related concerns of the student that
may affect the student's health and/or success in school;
(iii)
provision of neither reproductive services, counseling,
nor referrals through the school-based health center receiving grant funds
awarded under this subchapter;
(iv)
provision of all services by only appropriately licensed,
certified, or credentialed professionals as required by law;
(v)
referral of a student for mental health services only upon
notification of and with the written consent of the student's parent, which
must be followed by written consent by the student's parent for each treatment
occasion(s) authorized by the provider, including informed consent when required
for specific services;
(vi)
a good faith effort by staff of a school-based health
center located in a rural area described by §37.532(8) of this title
(relating to Definitions) to identify and coordinate with existing health
care providers;
(vii)
provision of notice by the staff of the school-based
health center to the primary care physician of a student who has received
services;
(viii)
coordination by the staff of the school-based health
center with the primary care physician concerning the clinical treatment of
any person who has a primary care physician under the state Medicaid program
or another health plan and obtaining authorization before delivering a service;
(ix)
utilization of all available sources of funding to compensate
the school district or provider with whom the district contracts for services
provided by a school- based health center;
(x)
conduct or facilitation of the conduct of client surveys
in school-based health centers by funded applicants; and
(xi)
documentation in the student's medical record of the school-
based health center's efforts to involve the student's parent in identification
of the student's health- related concerns; notification of the student's parent
of scheduled appointments and proposed services; coordination with the student's
primary care physician; and maintenance of written consent for treatment by
the student's parent, including informed consent when required for specific
services.
(3)
Emphasis on prevention. A funded applicant shall provide
for primary emphasis on the delivery of conventional health services and secondary
emphasis on the implementation of population-based models that prevent emerging
health threats by use of the following strategies:
(A)
increasing substantially the number of children in the
community with health-care (medical) homes;
(B)
facilitating access to appropriate primary and preventive
care for children and families;
(C)
educating, enabling, and empowering individuals for healthier
lifestyles;
(D)
involving the community in identifying priorities and developing
health promotion strategies; and
(E)
relying on the evidence of effective prevention to develop
interventions that can demonstrate impact.
(4)
Focus on outcomes. A funded applicant shall focus on the
achievement of outcomes that can be documented, using the following strategies:
(A)
delivering conventional health services and disease prevention
of emerging health threats through access to appropriate primary and preventive
care for children and families through a program designed to achieve the following
goals:
(i)
a reduction in student absenteeism and drop-out rates;
(ii)
an increase in each student's ability to meet his or her
academic potential; and
(iii)
stabilization of each student's physical well-being.
(B)
A funded applicant shall research, document, analyze, and
evaluate outcomes, including the goals listed in subparagraph (A) of this
paragraph, by activities that include but are not limited to the following:
(i)
gathering data and statistics, monitoring outcomes, and
producing data by use of quantitative measurement systems to report on project
impact as required by the Request For Proposals;
(ii)
providing quarterly reports as required by the department;
(iii)
conducting client surveys and other qualitative measures
of client satisfaction; and
(iv)
producing an annual written report that includes a project
evaluation with baseline data; data and analysis from client surveys; any
available statistics related to increased academic success, improved student
health, and improved performance on student assessment instruments administered
under Education Code, Chapter 39, Subchapter B; and other information as specified
by the department.
(5)
Compliance. A funded applicant shall provide to the department
annually a statement signed by a representative of the school district stating
that the district has made a good faith effort to meet all requirements of
the department.
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 July 27, 2000.
TRD-200005213
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: June 9, 2000
For further information, please call: (512) 458-7236
25 TAC §§96.101, 96.201 - 96.203, 96.301 - 96.304, 96.401, 96.402, 96.501, 96.601
The Texas Department of Health (department) adopts new §§96.101,
96.201- 96.203, 96.301-96.304, 96.401-96.402, 96.501, and 96.601, concerning
the standards for occupational exposure of governmental unit employees to
bloodborne pathogens. Sections 96.101, 96.302, and 96.401 are adopted with
changes to the proposed text as published in the March 10, 2000, issue of
the
Texas Register
(25 TexReg 1941). Sections
96.201-96.203, 96.301, 96.303-96.304, 96.402, 96.501, and 96.601 are adopted
without changes, and therefore the sections will not be republished.
The exposure control plan which is referenced in §96.202, Exposure
Control Plan, was published as a miscellaneous document in the March 10, 2000,
issue of the
Texas Register
(25 TexReg 2192).
This exposure control plan is adopted with changes as described in this preamble
in the comments and responses and will be republished with changes as a miscellaneous
notice in this issue of the
Texas Register.
These sections are adopted to extend the protections provided to employees
of private entities by Occupational Safety and Health Administration (OSHA)
rules, to employees of state and local governments, and for related purposes.
The new sections are required by Health and Safety Code, Chapter 81, Subchapter
H, which was added by Chapter 1411 (House Bill 2085), §§26.01-26.03,
76th Legislature.
The new sections decrease the risk of exposure to bloodborne pathogens
for employees who work in governmental units by increased training and education;
increased use of vaccination for employees; and increased use of personal
protective equipment. The recommendation for the use of needleless systems
and sharps with engineered sharps injury protection will reduce the risk of
injury and transmission of bloodborne pathogens to governmental unit employees.
The following comments were received concerning the proposed sections.
Following each comment is the department's response and any resulting change(s).
Comment: Concerning the proposed preamble for Chapter 96. Bloodborne Pathogen
Control, one commenter wrote, "that the second paragraph of the preamble to
the Final (sic) Proposed Bloodborne Pathogen Rule be amended to state: The
rules are needed to adopt minimum standards for an exposure control plan.
The plan would decrease the risk of exposure to bloodborne pathogens for employees
who work in governmental units by increased training and education; increased
use of vaccination for employees; and increased use of personal protective
equipment. The recommendation for the use of needleless systems and sharps
with engineered injury protection will reduce the risk of injury and transmission
of bloodborne pathogens to governmental unit employees. However, there are
other needlestick prevention technologies which the U.S. Food and Drug Administration
has determined to be safe and effective in reducing the risk of needlestick
injuries. These alternative technologies may also be used by governmental
units, if appropriate for their work site (...)".
Response: The department disagrees. The law is specific to the types of
devices to be addressed and the rules are written to strictly implement the
legislation. The proposed preamble cannot be amended because it is not part
of the rule. No change was made as a result of this comment.
Comment: Concerning the rules in general, one commenter wrote, "We support
the requirement to fully implement the OSHA bloodborne pathogen standard for
public and/governmental hospitals." The commenter has revised their exposure
control plan and is addressing the issue of safe needle devices. "We believe
that implementation of these regulations will improve employee and health
care worker safety."
Response: The department agrees and appreciates the commenter's support
for the proposed rules. No change was made as a result of this comment.
Comment: Concerning the rules in general, a commenter voiced concern about
"the short time for preparation and compliance with the new rules. Specifically
implementation by September 1, 2000, will be difficult due to a) limited supplies
reported by vendor, (b) limited budget for sharps systems changes and filing
fees (budgets already set), and (c) limited staff for registering, monitoring
compliance, and reporting as proposed."
Response: The department partially agrees. Many governmental agencies implemented
bloodborne pathogen standards for their agency several years ago when the
OSHA Bloodborne Pathogen Standards were implemented for the private sector.
For governmental agencies that did not implement an exposure control plan
similar to the OSHA standards set in 1992, the new rule will require the governmental
agencies to develop an exposure control plan, monitor their compliance, and
in addition report sharp injuries to their local health authority. The department
adhered to compliance dates set by the legislation during the rule making
process. The department is not clear on the reference on limited supplies
since this is a recommendation not a mandate. The department is not clear
about the commenter's statement regarding "limited staff for registration."
If the commenter is referring to the registration of needleless devices or
sharps with engineered sharps injury protection, this is the responsibility
of vendors working with the department to register devices. The department
will make a list of registered devices available to governmental agencies.
This activity will not be a local governmental unit activity. No change was
made as a result of this comment.
Comment: Concerning the rules in general, one commenter asked "Does the
rule apply to all TDCJ staff or only those who work in medical settings? The
definitions of sharps and sharp exposure appear limited to medical settings,
but the guards may have an exposure to a sharp that does not meet the definition
in the rule. For example, a paper clip sharpened and used as a tattoo needle."
Response: Section 96.401(d) regarding sharps injury reporting applies to
individuals working in a health care setting. The department agrees that other
types of sharp injuries occur outside of medical facilities on occasion. The
reporting component of this rule is limited to sharps that are encountered
in a health care setting. Sections 96.202 and 96.203 applies to all governmental
unit employees at risk for an occupational blood exposure regardless of their
employment setting. No change was made as a result of this comment.
Comment: Concerning the rules in general, one commenter stated, "The medical
staff in TDCJ is employed by UTMB or Texas Tech. It is not clear to me that
compliance would be the responsibility of the managed care contractors or
of TDCJ. Administratively, it would be difficult for TDCJ to hold the compliance
responsibility for the medical staff, since they already work for an employer
that has an infection control plan. There would also be a duplication of effort."
Response: The department agrees. A governmental employer is responsible
for implementation of an exposure control plan involving training their paid
employees regarding universal precautions and work practice controls, and
for ongoing treatment of a paid employee according to the employer's current
procedure for post-exposure follow-up. Unless otherwise specified in an agency
contract, a governmental agency that uses contract employees to provide services
within the governmental agency is not required to do exposure control training,
nor provide follow-up for bloodborne exposures that occur while the contract
employee is working in a governmental unit. The governmental agency would
be responsible to report the contractual employee's contaminated sharp injury
through the normal reporting mechanism. The employer is ultimately responsible.
Here both contractor and contracting entity are governmental agencies so contract
could address responsibilities. No change was made as a result of this comment.
Comment: Concerning proposed §96.101(4), "contaminated sharps injury"
definition, renumbered as §96.101(5), one commenter was concerned that
the definition would lead readers to believe that if blood or body fluids
are invisible on the sharp, then the sharp is not contaminated. The commenter
suggested that §96.101(4) be changed to read, "Any sharps injury that
occurs with a sharp used or encountered in a health care setting."
Response: The department partially agrees. The word "contaminated" has
been defined to mean the presence or reasonably anticipated presence of blood
or other potentially infectious material on an item or surface. By definition
"contaminated" does not depend on whether or not blood or other potentially
infectious body fluids are visible. The department agrees that sharp injuries
can occur prior to the use of the sharp (while the sharp is sterile) and during
or after use of the sharp. In addition, a "contaminated" sharp may not be
covered with blood or a body fluid that is visible to the naked eye. The department
also agrees that employers may require employees to report all sharp injuries
that occur, regardless of whether or not the sharp was contaminated. For the
purposes of this rule, the department only requires governmental entities
report "contaminated sharp injuries." The definition for the word "contaminated"
has been added to §96.101 as a result of this comment.
Comment: Concerning proposed §96.101(20)(G), "a dental knife, drill,
or bur", renumbered as §96.101(21)(G), one commenter suggested deleting
dental knife, since no such instrument is used in treating patients. "The
only dental type tool referred to as a "knife" is used in a laboratory, a
situation absent the possibility of blood contact." The commenter also suggested
deleting the word "drill." "These are more properly designated "handpieces"
and are not instruments capable of causing injuries; it is the burs used in
them that cause injury. The commenter suggested adding "(H) to include excavators,
explorers, and scalers."
Response: The department disagrees with the commenter regarding §96.101(20)(G).
"A dental knife, drill, or bur" is part of the definition supplied by the
statute and the department does not have the authority to change this language.
There are such devices as dental knives (officially referred to as periodontic
knives by the FDA) and they do indeed have clinical uses and could be associated
with a sharps related injury. No change was made as a result of this comment.
Comment: Concerning proposed §96.101(6), "employee" definition, renumbered
as §96.101(7), one commenter stated, "This regulation exceeds the federal
statute. It includes non-paid employees, such as students, public health nurses,
etc., who are not supervised or controlled by the governmental entity. It
would cause double reporting of healthcare workers' injuries as reports would
be filed by both their employer and by the governmental entity where working
at the time of the accident." Another commenter wrote, "The definition of
"employee" in §96.101(6) is overly broad and encompasses both contract
and temporary workers. While §96.201(c.) appears to limit the requirements
placed on the governmental unit for certain types of "employees," this limitation
requires further clarification."
Response: These new rules were written to implement state law, House bill
2085, Article 26. Federal regulations do not directly apply to these rules.
The committee that developed the proposed rule struggled with the definition
of employee during the rule making process. The Honorable Senator Bernsen
clarified the legislative intent regarding which employees are covered by
the statute for the committee. In a letter dated November 12, 1999, Senator
Bernsen wrote, "If the Board were to confine the reporting only to exposures
involving direct employees, the utility of the data would be dramatically
reduced. Obviously, we would then have no data on the scope of the problem.
As it is, only data from public institutions will be collected, but that is
data that can be projected with some degree of confidence on the state as
a whole. If reporting will vary widely from institution to institution based
on who contracts for services, how pervasively and in which departments, there
will be no way that meaningful conclusions can be drawn. Furthermore, the
extremely important Epidemiology of whether there is meaningful safety difference
between employees and contract personnel would be totally lost." No change
was made as a result of this comment.
Comment: Concerning proposed §96.101(9) "exposure incident" definition,
renumbered as §96.101(10), one commenter requested a clearer definition
of what constitutes an exposure incident. The commenter wrote "This broad
definition leads the regulated community to question when the requirements
for post-exposure evaluation and follow-up must occur. The plan requires post-exposure
evaluation and follow-up when an employee incurs an "exposure incident." This
follow-up includes numerous requirements, including medical evaluation and
counseling of the employee. Under the broad exposure incident definition,
would exposure to feces, urine, and other potentially infectious materials
of a special education teacher's or aide's in the course of potty training
a student qualify? Would this same teacher's changing of a diaper qualify?"
Response: The department disagrees. The occupational tasks of potty training
and diaper changing are not in and of themselves an exposure incident; but
both are activities during which an employer should reasonably anticipate
an exposure incident could occur. It is incumbent on the employer to train
employees regarding exposure control and provide the appropriate protective
equipment. Urine and feces are not body substances that normally contain blood
or bloodborne pathogens; but feces may contain other pathogens such as, hepatitis
A virus or Shigella. If an exposure incident should occur then the employee
should receive follow-up and/or treatment in order to prevent infection. For
example, immune globulin may be given to a teacher who has been exposed to
the stool of a child who has hepatitis A infection, thus preventing the teacher
from becoming ill with symptoms of hepatitis A infection. An employer would
not be required to report such an exposure as these rules require reporting
of sharp injuries only. No change was made as a result of this comment.
Comment: Concerning §96.101, "definitions", one commenter wrote, "Add
Sharps injury prevention technology to the list of definitions under Section
96.101 as number 22 and renumber accordingly."
Response: The department disagrees. Although the statute was written to
recommend the use of needleless systems and sharps with engineered sharps
injury protection, it does not exclude the use of other devices like the one
manufactured by this commenter. No change was made as a result of this comment.
Comment: Concerning §96.201, "applicability", one commenter wrote,
"that the first sentence of §96.201(c) be revised to read as follows:
Employees who are directly compensated by a governmental unit and who have
a risk of occupational exposure are subject to all provisions of this chapter."
Response: This language used in the proposed rule is directly from the
statute and does not include the word "occupational." No change was made as
a result of this comment.
Comment: Concerning §96.201(b), "local- or state-funded university
student infirmaries", one commenter stated that "the presence of such an infirmary
might make the university a "governmental unit" subject to this rulemaking
and applicable statute, the infirmary itself would not be a "governmental
unit."
Response: The department agrees. If a school infirmary is being operated
under the authority of a governmental unit then the rules would apply. If
the infirmary is privately operated under contract so that it comes under
existing OSHA regulations, then these rules would not apply. No change was
made as a result of this comment.
Comment: Concerning §96.203, "minimum standards", one commenter suggested
that the section be amended to allow employers to exclude provisions irrelevant
to their particular facility or organization.
Response: The department disagrees. Section 96.203(b) states, "Governmental
units may modify the plan appropriately to their respective practice settings.
Employers will need to include provisions relevant to their particular facility
or organization in order to develop an effective comprehensive exposure control
plan specific to their facility or organization." The current language allows
governmental units to modify the exposure control plan in order to make it
specific to their agency. No change was made as a result of this comment.
Comment: Concerning §96.301, "safety recommendations", one commenter
suggested §96.301(a) be "amended to state that: The Texas Department
of Health (department) recommends that governmental units implement needleless
systems and sharps with engineered sharps injury protection for employees.
However, there are other needlestick prevention technologies which the U.S.
Food and Drug Administration has determined to be safe and effective in reducing
the risk of needlestick injuries. These alternative technologies may also
be used by governmental units, if appropriate for their work site."
Response: The department disagrees. The intent of the statute was to recommend
the use of needleless systems and sharps with engineered sharps injury protection;
it does not preclude the use of any other technology that exists. No change
was made as a result of this comment.
Comment: Concerning §96.301(b)(1)(B), "waiver for undue burden," one
commenter wrote, "a more complete definition or explanation for "unduly burdensome"
would be very helpful."
Response: With regard to §96.301, in general, the department deliberately
left out a definition for unduly burdensome in the rule. The department has
no enforcement authority in this matter: it is the responsibility of the governmental
unit through it's evaluation committee to determine what constitutes an undue
burden. No change was made as a result of this comment.
Comment: Concerning §96.301(b), "waiver for undue burden," a commenter
wrote, "Section 81.305, Texas Health and Safety Code does not set up any procedure
or requirement for Texas Department of Health to issue a waiver of the Board's
recommendation regarding the implementation of needless (sic) systems and
sharps with engineered sharps injury protection. Instead, under Section 81.305(b)
of this statute, the evaluation committee of a governmental unit decides whether
the recommendation applies and then reports its decision to the Texas Department
of Health."
Response: The department agrees and has no enforcement authority over this
section of the rule. The department intends to acknowledge receipt of a request
for waiver for undue burden and maintain the waiver in an active file should
questions regarding the waiver arise. No change was made as a result of this
comment.
Comment: Concerning §96.301(a), three commenters requested clarification
of this section. "The section recommends the use of needleless systems and
engineered sharps, but (b) provides for waivers." "It is unclear why a waiver
is needed for something that is a recommendation and not a requirement. Please
clarify." "This makes paragraph (a) sound like a requirement, not a recommendation.
I always thought a recommendation could be ignored, and think this would be
clearer if it were reworded." "Suggest removing paragraph (b) and leaving
only paragraph (a) to remove ambiguity."
Response: Article 26, House Bill 2085, directs the Board of Health to recommend
the use of these devices, not require the use of them. The statute also provides
a waiver to the recommendation if an evaluation committee created in conformance
with §96.301(c)(1)(2) has established that the use of the needleless
systems or sharps with engineered sharps injury protection will jeopardize
patient or employee safety with regard to specific medical procedures or will
be unduly burdensome. No change was made as a result of these comments.
Comment: Concerning §96.301(a), one commenter supports the concept
of the use of needleless systems and sharps with engineered sharps injury
protection, but requests the implementation date, for the use of the devices,
be extended to January 1, 2002. The extended date would allow the governmental
unit to identify appropriate funding for this rule.
Response: The department has no authority to extend the implementation
dates as requested by the commenter. The statute sets the compliance dates
for the rule; any changes in these dates would have to be made by the legislature.
Section 96.301(b)(1)(B) provides a waiver to the recommendation in §96.301(a)
if an "evaluation committee" has determined that compliance would be unduly
burdensome or jeopardize patient or employee safety with regard to a specific
medical procedure. No change was made as a result of this comment.
Comment: Concerning §96.301(a), one commenter urges the department
" to replace your recommendation with a mandate in order to effectively protect
Texas healthcare workers."
Response: The Texas Board of Health was mandated by the legislature to
recommend the use of these devices; legislation would be required for the
department to mandate the use of these devices. No change was made as a result
of this comment.
Comment: Concerning §96.301(a), one commenter suggested broadening
the implementation recommendations. The commenter wrote, "The Texas Department
of Health (department) recommends that governmental units implement needleless
systems, (delete and) sharps with engineered sharps injury protection, or
other sharps injury prevention technology for employees." The commenter stated
that this wording is consistent with the 1999 OSHA Compliance Directive requiring
"comprehensive approach" and "not advocating the use of one particular device
over another." The commenter further explained that the added language "allows
and encourages the use of other appropriate technologies as they become available.
The Department would not have to rewrite regulations if the Legislature changed
recommends to required."
Response: The department disagrees. By adding the term "sharps injury prevention
technology" to §96.301(a), as suggested by the commenter, the types of
devices eligible for inclusion in the registration program would be expanded
beyond the scope of the statutory definitions for the terms "needleless system"
or "engineered sharps injury protection". No change was made as a result of
this comment.
Comments: Concerning §96.302(a), "device registration", one commenter
suggested adding the terminology "sharps injury prevention technology." The
commenter wrote, "The Texas Department of Health (department) shall compile
and maintain a list of needleless system devices, (delete and) sharps devices
with engineered sharps injury protection and sharps injury prevention technology
that are available in the commercial marketplace and registered with the department
to assist governmental units to comply with this chapter." The commenter also
wrote, "In (b), (c), (e), (g), (h), (k)(4), (l) add or sharps injury prevention
technology after engineered sharps injury protection."
Response: The department disagrees. By adding the term "sharps injury prevention
technology" to §96.302(a), as suggested by the commenter, the types of
devices eligible for inclusion in the registration program would be expanded
beyond the scope of the statutory definitions for the terms "needleless system"
or "engineered sharps injury protection". No change was made as a result of
this comment.
Comment: Concerning §96.301(a), §96.302, and §96.303, "safety
recommendations, device registration, and registration procedures" one commenter
wrote, "Paragraph 301(a) does not state that registered needleless devices
are recommended or required. Sections 302 and 303, however, offer lengthy
discussion for needeless (sic) device manufacturers to register their product(s)
with TDH. This ambiguous information should be clarified."
Response: The department disagrees. Article 26 House Bill 2085 directed
the Board of Health to recommend the use of needleless devices and sharps
with engineered sharps injury protection. In addition, the statute directed
the department to compile and maintain a list of needleless system devices
and sharps with engineered sharps injury protection that are available in
the commercial market place to assist governmental units to comply with this
chapter. Each device manufacturer who manufactures a needleless system device
or sharps device with engineered sharps injury protection and wants to register
with the department will pay a fee to be on this list of devices. Governmental
units may use the list to identify available products in the marketplace,
but the department does not endorse any device that is registered with the
department nor does the department require the use of the devices on the list.
No change was made as a result of this comment.
Comment: Concerning §96.303(a), one commenter wrote, "add sharps injury
prevention technology to registration procedures in section 96.303(a) after
engineered sharps injury protection."
Response: The department disagrees. By adding the term "sharps injury prevention
technology" to §96.303(a), as suggested by the commenter, the types of
devices eligible for inclusion in the registration program would be expanded
beyond the scope of the statutory definitions for the terms "needleless system"
or "engineered sharps injury protection". No change was made as a result of
this comment.
Comment: Concerning §96.304, "registration fees", one commenter stated
that "the requirement for a registration fee is onerous on its face and the
$1,500 initial fee with a $1,000 annual renewal is excessive in any case.
The most likely effect of these fees will be to prevent healthcare workers
from learning about new technology, especially from smaller manufacturers
due to the high fee amounts. It is also unclear whether the fees apply to
a "class" or type of product, or to each individual item. In either case we
urge you to waive all fees to assure complete participation by manufacturers
so that Texas healthcare providers and workers will have access to the most
current and effective technologies."
Response: The department disagrees. Section 81.307, Article 26, House Bill
2085, directs the Board of Health to charge fees for the registration of each
device to be included in a list that will be made available to governmental
entities. The statute clearly indicates that these fees may be appropriated
only to the department to implement the Subchapter. The department anticipates
that program costs will include, among other activities, the review and approval
of device registration applications, compiling and maintaining the registration
list, the collection and reporting of sharps injuries data, waiver request
review, and the dissemination of information related to bloodborne pathogen
control. The department has deliberated at length through its stakeholder
committee meetings, which included industry representation, in order to establish
fees that will be expected to cover the startup and operational costs associated
with this new program. The department realizes that these costs may change
over time and therefore intends to continually reevaluate the appropriateness
of the fees. In addition, the department believes that the language in §§96.302
and 96.303 is sufficient to reflect that the registration fee for each device
is not meant to refer to a class or type of product, but rather to each device
as identified by name. Nothing prevents manufacturers from using traditional
promotion methods to inform healthcare workers about their products. No change
was made as a result of this comment.
Comment: Concerning §96.304, "registration fees", one commenter wrote,
"add sharps injury prevention technology to registration fees in Section 96.304."
With the suggested change the section would read, "The Texas Department of
Health (department) shall charge a fee to register a needleless system device
or sharps device with engineered sharps injury protection or sharps injury
prevention technology."
Response: The department disagrees. The legislation is specific to needleless
system devices or sharps with engineered sharps injury protection, and the
rules are written to comply with this legislation. No change was made as result
of this comment.
Comment: Concerning §96.401(d), "sharps injury log", one commenter
wrote, "the deadline for reporting contaminated sharps injury should be extended
to one month plus ten working days after the injury has been reported. The
current deadline is too restrictive and may occasionally not be met."
Response: The department disagrees with the commenter to extend the deadline
for reporting; the department expects reporting in a timely fashion. On occasion
a contaminated sharps injury may occur that would pose a difficulty for the
agency to meet the reporting deadline, but there is no penalty for late reporting.
No change was made as a result of this comment.
Comment: Concerning §96.401, "sharps injury log", one commenter stated,
"this rulemaking raises the possibility of the dual reporting of a contaminated
sharps injury for example, if a medical resident receives such an injury both
the medical school and the hospital may need to report the injury."
Response: The department disagrees. Section 96.401 does not require that
both entities report the injury. For example, if the medical student is injured
while working within the hospital, the hospital should report the injury.
This may require better communication and coordination of reporting efforts
between entities that have dual responsibilities for employees. No change
was made as a result of this comment.
Comment: Concerning §96.401, "sharps injury log", one commenter stated
"As many as 50% of sharps injuries may not be reported by healthcare workers.
The department requires collection of a large volume of data for each sharps
injury. How does the department plan to make use of this data given that it
may represent no more than half of the sharps injuries that occur? How will
the data be analyzed? What is the denominator? How will the data be reported
back to the institutions that provided it? Will benchmarks be established?
Another commenter wrote, "The sharps injury log is an overbearing way of gathering
statistics. At most, filing this data should be voluntary. Implementing such
a requirement at the universities and agencies would be nearly impossible.
Suggest that the TDH coordinate with the Texas Workers' Compensation Commission
(TWCC) to generate sharps injury reports from TWCC electronic files, which
will include all state agency employees. This would reduce the burden on individual
employers and eliminate a paperwork jumble."
Response: Health and Safety Code, §81.306, Article 26, House Bill
2085, states "the board by rule shall require that information concerning
exposure incidents be recorded in a written or electronic sharps injury log
to be maintained by a governmental unit. This information must be reported
to the department and must include: the date and time of the exposure incident;
the type and brand of sharp involved; and a description of the exposure incident,
including; the job classification or title of the exposed employee; the department
or work area where the exposure incident occurred; the procedure that the
exposed employee was performing at the time of the incident; how the incident
occurred; the employee's body part that was involved in the exposure incident;
and whether the sharp had engineered sharps injury protection and, if so,
whether the protective mechanism was activated and whether the injury occurred
before, during, or after the activation of the protective mechanism." The
department is also required in Health and Safety Code, §81.306(c) to
make the information reported available in aggregate form, provided that the
name and other information identifying the facility is deleted and the information
is provided according to public health regions established by the department.
The department will report the total number of needlesticks (numerator data
only) by public health region. The department understands the commenter's
concern about not collecting a denominator in order to calculate rates, but
at this time the collection of a denominator is not feasible. Benchmarking
for sharp injuries by the department is not feasible; it is anticipated that
institutions could develop benchmarks for themselves. Since governmental agencies
are currently sending reports of sharp injuries to the TWCC and if the report
contains all the required elements to be reported to the department the governmental
unit could consider sending a copy of the TWCC report to the department. No
change was made as a result of this comment.
Comment: Concerning §96.401(c)(11), regarding the history of hepatitis
B vaccine, one commenter wrote, "Some healthcare workers are poor historians
and do not remember receiving three doses of the hepatitis B vaccine or attending
bloodborne pathogen education. While this information can be verified for
our own employees, it would be labor intensive trying to obtain and verify
this information on non-employees. Statistical information in which we have
no control may result in skewed numbers that may reflect adversely on the
governmental entity." Another commenter wrote, "In relation to sharps injuries, §96.201
and §96.401 would apparently require the governmental unit to supply
information regarding whether a contract or temporary worker had completed
a hepatitis B vaccination series and had received training on the Exposure
Control Plan during the last 12 months. Compliance with these requirements
for a contract or temporary worker would be difficult and burdensome."
Response: The department partially agrees. In the rare instance that contract
or temporary employees may not recall their hepatitis B vaccination status
nor recall their training history, immediately after an exposure incident,
verification may be difficult. In these instances where the worker does not
easily recall the information, the reporting entity might need to state that
the information requested is "unknown." No change was made as a result of
this comment.
Comment: Concerning §96.401, "sharps injury log", one commenter indicated
that the facilities within the TDCJ system routinely report to the central
office in Huntsville and "Reporting from each facility would impose a dual
reporting burden on the facility, since they must report to Huntsville in
order to get reimbursed for treating an exposure."
Response: The department agrees. Agencies should report sharp injuries
to the department using their normal reporting mechanisms. In most instances
this reporting would be through the local health department. Agencies with
non-traditional reporting mechanisms (i.e., do not routinely send reports
to the local health department) can continue to use their standard reporting
procedures (i.e., report to their regional office or directly to the central
office). No change was made as a result of this comment.
Comment: Concerning §96.401(c) , "sharps injury log", one commenter
wrote that the "sharps log seems out of place. It is in the middle of the
reporting requirements. If this is the information that must be reported,
then it should be labeled as such. Another sentence could be added that the
information also has to be maintained in a log." Another commenter wrote,
"It will also be difficult to include an updated listing of implemented needleless
systems and safety- engineered sharps available to an injured employee with
each sharps injury report as required in §96.401(b)(18)."
Response: The department agrees that clarification is needed. Language
has been added to §96.401(d) to read, "Information contained in §96.401(c)(1)
(17) concerning each contaminated sharps injury shall be reported not later
than 10 working days after the end of the calendar month in which it occurred."
Concerning §96.401(b)(18), Article 26 House Bill 2085 requires that a
listing of available needleless systems and sharps with engineered sharps
injury protection be available for employees within the governmental entity
and is not part of the reporting requirement. A change in §96.401(d)
has been made as a result of these comments.
Comment: Concerning §96.402, "confidentiality statement", one commenter
wrote, Texas Hospital Association (THA) "strongly supports the department's
efforts to maintain the confidentiality of information related to occupational
exposures that is reported to TDH or its agents. The department has indicated
that it expects to address actual disclosure of this information through TDH
policies and procedures, so that hospitals' concerns about confidentiality
and use of the information reported may be addressed. THA recommendation:
that THA be included in the discussions and development of TDH policies and
procedures regarding disclosure of information reported to or compiled by
TDH, so that THA's concerns about the confidentiality and use of the information
may be addressed."
Response: Standard policies and procedures exist to govern reporting of
surveillance data and these data are considered both confidential and privileged.
Certainly the department would be willing to discuss the issue with any concerned
party. No change was made as a result of this comment.
Comment: Concerning the exposure control plan "compliance methods" section,
published in the March 10, 2000, issue of the
Texas
Register
(25 TexReg 2192), one commenter believes the plan should be
amended to "explicitly permit the use of a wide range of effective needlestick
prevention technologies." The commenter requested, that in the third sentence
of the second paragraph which starts "Examples include .", the following be
added to the sentence "other technologies that the U.S. Food and Drug Administration
has determined to be safe and effective in reducing the risk of needlestick
injuries..." The commenter also stated "The decision of which FDA-cleared
and approved needlestick prevention devices to use should rest with the employer."
Response: The department's exposure control plan "compliance methods" section
states, "Engineering and work practice controls are used to eliminate or minimize
exposure to employees. Where occupational exposure remains after institution
of these controls, personal protective equipment is used. Examples include
safety design devices, sharps containers, needleless systems, sharps with
engineered sharps injury protection for employees, passing instruments in
a neutral zone, etc." "Work practice controls" means controls that reduce
the likelihood of exposure by altering the manner in which a task is performed
and "engineering controls" means controls that isolate or remove the bloodborne
pathogens hazard from the workplace. This language adequately addresses the
commenter's concern about the existence of other technologies without a long
list of other available controls available in the marketplace. No change was
made as a result of this comment.
Comment: Concerning the exposure control plan "interaction with healthcare
professionals" section, one commenter suggested that item (5) be revised to
read as follows: "(5) whether the employee has been told about any medical
conditions resulting from exposure to blood or other potentially infectious
materials which require further evaluation or treatment (all other findings
or diagnosis shall remain confidential and shall not be included in the written
report); and"
Response: The department agrees. Under the section "Interaction with Healthcare
Professionals," regarding written opinions from the healthcare professionals,
the second #5 has been changed to the commenter's suggested wording.
Comment: Concerning the exposure control plan, one commenter requested
that the department allow the employer to determine whether to make hepatitis
B vaccine available to employees as a pre-exposure or as a post-exposure series.
"Since post-exposure vaccination is effective in most instances, it would
be much more reasonable and cost effective to provide flexibility in the HBV
vaccination program."
Response: The department disagrees. According to the CDC Personnel Health
Guideline published in 1998,"nosocomial transmission of HBV is a serious risk
for health care personnel. Approximately 1000 health care personnel were estimated
to have become infected with HBV in 1994." The guideline also states, "Hepatitis
B vaccination of health care personnel who have contact with blood and body
fluids can prevent transmission of HBV and is strongly recommended." The guideline
does not include the option of the sole use of post-exposure vaccination as
a means to prevent this infection. The department agrees that post-exposure
vaccination in conjunction with hepatitis B immune globulin is effective in
reducing the risk of HBV infection in employees who refuse hepatitis B vaccine
or who are hepatitis B vaccine non- responders. As stated in §96.203(b)
"Governmental units may modify the plan appropriately to their respective
practice settings. Employers will need to include provisions relevant to their
particular facility or organization in order to develop an effective, comprehensive
exposure control plan specific to their facility or organization." No change
was made to the exposure control plan as a result of this comment.
Comment: Concerning the exposure control plan regarding "training", one
commenter wrote, "Annual refresher training is burdensome."
Response: The department disagrees. Effective training is a critical element
of any overall exposure control plan. The department has concluded that it
is essential for employees to understand the nature of the hazards they may
face in the course of their employment and the procedures to follow to minimize
or eliminate the risks associated with their exposure to these hazards. Because
of the severity of the diseases and the potential to contract them from a
single event, it is also important to retrain workers exposed to bloodborne
pathogens on an annual basis. Annual retraining allows an employer to refresh
and update employee knowledge and may not require the extensive efforts in
the initial training. It also provides an opportunity to present new information
that had not been available at the time of initial training. No change was
made to the exposure control plan as a result of this comment.
Comment: Concerning the exposure control plan, one commenter wrote, "The
first item listed to be covered in the training program requirements is the
OSHA Bloodborne Pathogen Final Rule. Covering the TDH Bloodborne Pathogen
Control Rule makes more sense."
Response: The department partially agrees. The first item on the list should
include Chapter 96. Bloodborne Pathogen Control but the OSHA Bloodborne Pathogen
Final Rule should also be reviewed. Covering Chapter 96 will include the minimum
standards for exposure control and a review of the OSHA Bloodborne Pathogen
Final Rule will give employees a basis for the department's exposure control
plan. The exposure control plan list has been changed.
Comment: Concerning the exposure control plan "record keeping" section,
one commenter wrote, "In the recordkeeping section, the plan states, 'According
to OSHA's Bloodborne Pathogens Standard, medical records (and training records)
are maintained by:' Does this mean the employers are to follow OSHA's requirements
(i.e., retention for 30 years)? Keeping medical records for 30 years, as required
by the OSHA standard, would be very cumbersome."
Response: Under the "Recordkeeping"" section of the plan no reference to
the length of time medical record information should be maintained is cited.
Governmental units should maintain employee records according to agency policy
and/or in accordance with any applicable state or federal regulations regarding
record retention. The department developed this exposure control plan to be
analogous to the OSHA Bloodborne Pathogen standard as required by the statute.
As stated in the "Guidance" section of the exposure control plan, "Governmental
units may modify the plan appropriately to their respective practice settings.
Employers will need to include provisions relevant to their particular facility
or organization in order to develop an effective, comprehensive exposure control
plan." No change was made to the exposure control plan as a result of this
comment.
Comment: Concerning the exposure control plan "post exposure evaluation
and follow up" section, one commenter suggested the plan "allow versus require
testing of the source. In the alternative, specifically state that if the
source does not want to consent to the test the affected governmental entity
is not required to obtain consent."
Response: The department partially agrees. The wording "require testing
of the source" is not contained in the Post Exposure Evaluation and Follow
up section of the exposure control plan. The department has clarified the
section by deleting "If possible, the identification of the source individual.
The blood of the source is tested for HIV/HBV infectivity. Consent is obtained
if required by law." The department has added the following to the post exposure
evaluation and follow up section of the exposure control plan as a result
of this comment. "Identification and documentation of the source individual,
unless the employer can establish that identification is infeasible or prohibited
by state or local law. After obtaining consent, unless law allows testing
without consent, the blood of the source individual should be tested for HIV/HBV
infectivity, unless the employer can establish that testing of the source
is infeasible or prohibited by state or local law."
Comment: Concerning the exposure control plan, one commenter requested
amendment of "the exposure control plan to provide more flexible and less
stringent standards than OSHA's standards based on input from affected governmental
entities."
Response: The department disagrees. The language contained in §96.203(b)
states, "Employers should review the plan for particular requirements as applicable
to their specific situation. Governmental units may modify the plan appropriately
to their respective practice settings. Employers will need to include provisions
relevant to their particular facility or organization in order to develop
an effective, comprehensive exposure control plan specific to their facility
or organization." The language in this section adequately addresses the commenter's
concern regarding flexibility with the exposure control plan. No change was
made to the exposure control plan as a result of this comment.
Comment: Concerning the exposure control plan "personal protective equipment"
section, one commenter respectfully requested, "the Exposure Control Plan
proposed by the department be amended so as to include "puncture resistant
protective fingerguards" on the list of examples of available PPE.
Response: The department disagrees. The department feels that these devices
are adequately addressed as safety design devices in the ECP "compliance methods"
section which states; "Examples include safety design devices, sharps containers,
needleless systems, sharps with engineered sharps injury protection for employees,
passing instruments in a neutral zone, etc." No changes was made to the exposure
control plan as a result of this comment.
Comment: Concerning the exposure control plan, Appendix B, "assessment
tool", one commenter requested that the following be added to the tool, "Employees
wear appropriate needlestick prevention finger guards during those procedures
where fingers and thumb are at risk to percutaneous injury."
Response: The department disagrees. The assessment tool adequately addresses
the commenter's concern about the use of engineering controls in the work
center in statement #4 of the assessment tool. Appendix B is designed as a
model for governmental entities to use to monitor compliance with their specific
agency's exposure control plan. Monitoring of compliance is the responsibility
of the agency and the manner in which they use the tool is up to the employer.
The employer may choose to include a list of devices available in the agency
and monitor compliance with each device with the assessment tool. No change
was made to the exposure control plan as a result of this comment.
Comment: Concerning the exposure control plan "laundry procedures" section,
one commenter wrote, "If the rule applies to all of TDCJ, I do not think the
exposure control plan properly addresses laundry. It would be a burden to
consider all TDCJ laundry to be contaminated. This requirement should be limited
to laundry generated in the medical department." Two other comments regarding
the laundry section were received. One commenter wrote," ...the ECP requires
all used laundry be treated as contaminated although this is not an OSHA requirement."
The other commenter suggested deleting the first sentence in the Laundry Procedure
section.
Response: The department agrees. The Laundry Procedures section of the
exposure control plan has been reworded. The following statement from The
Centers for Disease Control and Prevention, "Guidelines for isolation precautions
in hospitals" regarding Linen and Laundry has been modified and has been added
to the exposure control plan section labeled "Laundry Procedures." "Although
soiled linen may be contaminated with pathogenic microorganisms, the risk
of disease transmission is negligible if it is handled, transported, and laundered
in a manner that avoids transfer of microorganisms to patients, personnel,
and environments. Rather than rigid rules and regulations, hygienic and common
sense storage and processing of clean and soiled linen are recommended. The
methods for handling, transporting, and laundering of soiled linen are determined
by the agencies written policy and any applicable regulations." The last sentence
in the Laundry Procedures section will be maintained, "Laundry is cleaned
at: (designate onsite or name offsite facility.)"
Comment: In the Post Exposure Follow up section of the exposure control
plan, results of the source individual's testing must be made available to
the exposed employee. I believe statutes only clearly allow this if the exposed
employee is a medical employee. If it is a public safety officer, disclosure
is only clearly allowed if the source is tested under mandatory testing (81.050,
Health and Safety Code). I would like to be able to disclose results to our
exposed security officers without having to go through the formality of 81.050,
so would actually like to see this addressed legislatively, the next time
Chapter 81 is opened in legislature.
Response: The department agrees that this issue needs to be addressed at
the legislative level. No change was made to the exposure control plan as
a result of this comment.
Comment: Concerning the exposure control plan "hepatitis B vaccine" section,
one commenter suggested to "Amend the plan by deleting the requirements that
the hepatitis B vaccine be provided at no cost to employees. Alternatively,
amend the plan to allow governments to assess the level of exposure risk and
at their discretion provide certain employees with the hepatitis B vaccine
at no cost."
Response: The department disagrees. The exposure control plan in the exposure
determination section states, " (plan) requires employers to perform an exposure
determination for employees who have occupational exposure to blood or other
potentially infectious materials. The exposure determination is made without
regard to the use of personal protective equipment." The hepatitis B vaccine
section of the plan states, "All employees who have been identified as having
occupational exposure to blood or other potentially infectious materials are
offered the hepatitis B vaccine, at no cost to the employee, under the supervision
of a licensed physician or licensed healthcare professional." This language
adequately addresses the commenter's concern. No change was made to the exposure
control plan as a result of this comment.
Comment: Concerning the exposure control plan "personal protective equipment"
section, one commenter requested the plan be amended "to give affected governmental
entities the discretion to provide equipment to certain employees free of
cost to the employee. Amend the plan to give affected governmental entities
the discretion to decide which employees should be trained and recommend rather
than mandate the appropriate credentials for trainers."
Response: The department disagrees. Regarding the commenter's concern about
personal protective equipment the plan states, "Personal protective equipment
is chosen based on the anticipated exposure to blood or other potentially
infectious materials." This language adequately addresses the commenter's
concern about providing personal protective equipment. Under the training
section the plan states, "Training for all employees is conducted prior to
initial assignment to tasks where occupational exposure may occur." The language
in this section adequately addresses the commenter's concern. No change was
made to the exposure control plan as a result of this comment.
Comment: Concerning the exposure control plan, one commenter wrote, "The
ECP "Housekeeping" section requires the use of an EPA registered germicide
although the OSHA standards in this area are not so restrictive."
Response: The department agrees. Under the "Housekeeping" section of the
plan the first sentence will be deleted. The following sentence has been added,
"Employers shall ensure that the worksite is maintained in a clean and sanitary
condition. The employer shall determine and implement an appropriate written
schedule for cleaning and method of decontamination based upon the location
within the facility, type of surface to be cleaned, type of soil present,
and tasks or procedures being preformed in the area."
Comment: Concerning the exposure control plan, one commenter wrote, "The
ECP "Specimens" section exempts certain containers with specimens from labeling
requirements, but this exemption is not mentioned in the "Labels" section.
Response: The department agrees that some clarification is needed regarding
the "Specimens" and "Labels" sections. The "Specimens" section applies to
the collection of blood or other specimens from a person. In the "Specimens"
section the following changes have been made. The first two sentences in the
section have been deleted. The title of the section has been changed to "Collection
of Specimens." The following statements have replaced the first two deleted
sentences. "Specimens of blood and other potentially infectious body substances
or fluids are usually collected within a hospital, doctor's office, clinic,
or laboratory setting. Labeling of these specimens should be done according
to the agency's specimen collection procedure. This procedure should address
placing the specimen in a container, which prevents leakage during the collection,
handling, processing, storage, transport, or shipping of the specimens. In
facilities where specimen containers are sent to other facilities and/or universal
precautions are not used throughout the procedure, a biohazard or color-coded
label should be affixed to the outside of the container." The rest of the
section will remain the same. The "Labels" section has been clarified by changing
the section title to "Use of Biohazard Labels." Agencies should have a procedure
that determines when biohazard-warning labels are to be affixed to containers
or placed in color- coded bags. The procedure should include the types of
materials that should be labeled as biohazard material. These materials may
include but are not limited to, regulated waste, refrigerators and freezers
containing blood or other potentially infectious materials, and other containers
used to store, transport, or ship blood or other potentially infectious materials.
The department appreciates the commenter's suggestions for clarification.
Comment: Concerning the exposure control plan, one commenter wrote, "Appendix
B, item 21 of the ECP is confusing. It discusses requirements for "regulated
medical waste", waste," and "regulated waste" and should be clarified."
Response: The department agrees. In appendix B, item 21 has been changed
to read "Employees demonstrate knowledge of the agency's policies regarding
disposal and transport of regulated waste by placing regular waste, special
waste, and/or biohazard waste in appropriate containers and transporting the
waste according to policy."
Comment: Two comments were received regarding the reporting form to be
provided by the department for governmental entities to use to report sharp
injuries. One commenter requested that the form be changed to state "student
working in the provision of health care." The other commenter stated, "Line
2, Type and brand of sharp Does not mention dental instruments; Line 3, Original
intended use It lists drilling but does not specify medical or dental use;
Line 10, Location where sharps injury occurred--Should list university, not
just a school, clinic should specify medical or dental; Line 11, Work area
where injury occurred Should include dental operatory, dental clinic, operating
room, student health clinic."
Response: The comments have been forwarded to the Infectious Disease Epidemiology
and Surveillance Division for their consideration of this comment on the reporting
form. The form is not a part of the rule and comments regarding the form may
be directed to Dr. Kate Hendricks, Division Director, Infectious Disease Epidemiology
and Surveillance Division. The department appreciates the commenter's review
of the Sharps Injury Reporting Form.
The commenters were Representative Harryette Ehrhardt, Senator David Bernsen,
Harris County Hospital District, University of Texas Medical Branch at Galveston,
City of Denton Landfill, SafetySyringes, Inc.
TM
,
Austin/Travis County Health and Human Services Department, Parkland Health
and Hospital System, Primary Care Department City of Austin, Texas Association
of School Boards, University of Texas MD Anderson Cancer Center, Texas Hospital
Association, MedPro, Inc., Texas Department of Criminal Justice, Texas A&M
University System, Bio Medical Disposal, University of Texas System, Digit-Pro,
Inc. Three commenters were in favor of the rules in their entirety. The other
commenters were not against the rules in their entirety, however they expressed
concerns, asked questions, and suggested recommendations for change as discussed
in the summary of comments.
The new sections are adopted under Health and Safety Code §81.303
which requires the department to establish an exposure control plan; Health
and Safety Code §81.304 which requires the board to adopt minimum standards
to implement the exposure control plan; Health and Safety Code §81.305
which requires the board to recommend by rule that governmental units implement
needleless systems; Health and Safety Code §81.306 which requires the
board to require the reporting of information concerning exposure incidents;
Health and Safety Code §81.307 which requires the board to implement
a registration program for existing needleless systems and sharps with engineered
sharps injury protection; Chapter 1411 (House Bill 2085), §26.02, 76th
Legislature, which allows the board by rule to waive application of Health
and Safety Code, Chapter 81, Subchapter H, for certain rural counties; Health
and Safety Code §81.021 which requires the board to exercise its power
in matters relating to protecting the public health to prevent the introduction
of disease into the state; Health and Safety Code §81.004 which allows
the board to adopt rules necessary for the effective administration and implementation
of Chapter 81; and Health and Safety Code, §12.001, which provides the
board with authority to adopt rules to implement every duty imposed by law
on the board, the department, and the commissioner of health.
§96.101.Definitions.
The following words and terms when used in this chapter shall have
the following meanings unless the context clearly indicates otherwise.
(1)
Blood - Human blood, human blood components, and products
made from human blood.
(2)
Bloodborne pathogens - Pathogenic microorganisms that are
present in human blood and that can cause diseases in humans, and include:
(A)
hepatitis B virus (HBV);
(B)
hepatitis C virus (HCV); and
(C)
human immunodeficiency virus (HIV).
(3)
Contaminated The presence or reasonably anticipated presence
of blood or other potentially infectious material on an item or surface.
(4)
Contaminated equipment - Any equipment used in the workplace
that has been soiled with blood or other potentially infectious materials
on an item or surface.
(5)
Contaminated sharps injury - Any sharps injury that occurs
with a sharp used or encountered in a health care setting that is contaminated
with human blood or body fluids.
(6)
Device - An instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory that is:
(A)
recognized in the official United States Pharmacopoeia
National Formulary or any supplement to it;
(B)
intended for use in the diagnosis of disease or other conditions,
or in the cure, mitigation, treatment, or prevention of disease in man or
other animals; or
(C)
intended to affect the structure or any function of the
body of man or other animals and that does not achieve any of its principal
intended purposes through chemical action within or on the body of man or
other animals and is not dependent on metabolization for the achievement of
any of its principal intended purposes.
(7)
Employee - An individual who works for a governmental unit
or on premises owned or operated by a governmental unit whether or not he
or she is directly compensated by the governmental unit.
(8)
Employs - Engages the services of employees.
(9)
Engineered sharps injury protection - A physical attribute
that:
(A)
is built into a needle device used for withdrawing body
fluids, accessing a vein or artery, or administering medications or other
fluids and that effectively reduces the risk of an exposure incident by a
mechanism, such as barrier creation, blunting, encapsulation, withdrawal,
retraction, destruction, or another effective mechanism; or
(B)
is built into any other type of needle device, into a nonneedle
sharp, or into a nonneedle infusion safety securement device that effectively
reduces the risk of an exposure incident.
(10)
Exposure incident - A specific eye, mouth, other mucous
membrane, nonintact skin, or parenteral contact with blood or other potentially
infectious materials that results from the performance of an employee's duties.
(11)
Governmental unit - This state and any agency of the state,
including a department, bureau, board, commission, or office and includes:
(A)
a political subdivision of this state, including any municipality,
county, or special district; or
(B)
any other institution of government, including an institution
of higher education.
(12)
HBV - Hepatitis B virus.
(13)
HCV - Hepatitis C virus.
(14)
Health care professional - A person whose legally permitted
scope of practice allows him or her to independently evaluate an employee
of a governmental unit and determine the appropriate interventions after an
exposure incident; this would include hepatitis B vaccination and postexposure
evaluation and follow up.
(15)
HIV - Human immunodeficiency virus.
(16)
Needleless system - A device that does not use a needle
and that is used:
(A)
to withdraw body fluids after initial venous or arterial
access is established;
(B)
to administer medication or fluids; or
(C)
for any other procedure involving the potential for an
exposure incident.
(17)
Occupational exposure - A reasonably anticipated skin,
eye, mucous membrane, or parenteral contact with blood or other potentially
infectious materials that may result from the performance of an employee's
duties.
(18)
Other potentially infectious materials include:
(A)
the following human body fluids: semen, vaginal secretions,
cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal
fluid, amniotic fluid, saliva in dental procedures, any body fluid that is
visibly contaminated with blood, and all body fluids in situations where it
is difficult or impossible to differentiate between body fluids;
(B)
any unfixed tissue or organ (other than intact skin) from
a human, living or dead; and
(C)
HIV-containing cell or tissue cultures, organ cultures,
and HIV- or HBV- containing culture medium or other solutions; and blood,
organs, or other tissues from experimental animals infected with HIV or HBV.
(19)
Personal protective equipment - Specialized clothing or
equipment worn by an employee for protection against a hazard. General work
clothes (eg, uniforms, pants, shirts, or blouses) not intended to function
as protection against a hazard are not considered to be personal protective
equipment.
(20)
Regulated waste/special waste from health care-related
facilities - Solid waste which if improperly treated or handled may serve
to transmit an infectious disease(s) and which is composed of the following:
(A)
animal waste;
(B)
bulk blood, bulk human blood products, or bulk human body
fluids;
(C)
microbiological waste;
(D)
pathological waste; or
(E)
sharps.
(21)
Sharp - An object used or encountered in a health care
setting that can be reasonably anticipated to penetrate the skin or any other
part of the body and to result in an exposure incident and includes:
(A)
needle devices;
(B)
scalpels;
(C)
lancets;
(D)
a piece of broken glass;
(E)
a broken capillary tube;
(F)
an exposed end of a dental wire; or
(G)
a dental knife, drill, or bur.
(22)
Sharps injury - Any injury caused by a sharp, including
a cut, abrasion, or needlestick.
(23)
Universal precautions/standard precautions - Approaches
to infection control as defined in Title 29 Code of Federal Regulation §1910.1030,
Occupational Safety and Health Administration (OSHA), Bloodborne Pathogens
Standard and Morbidity and Hospital Infection Control Practices Advisory Committee,
Guideline for isolation precautions in hospitals published in
Infection Control Hospital Epidemiology
, 1996;17:53-80, and
American Journal of Infection Control
, 1996;24:24-52. According to
the concept of universal precautions, all human blood and certain human body
fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne
pathogens.
§96.302.Device Registration.
(a)
The Texas Department of Health (department) shall compile
and maintain a list of needleless system devices and sharps devices with engineered
sharps injury protection that are available in the commercial marketplace
and registered with the department to assist governmental units to comply
with this chapter.
(b)
Each needleless system device or sharps device with engineered
sharps injury protection that is the subject of the department's device registration
application shall be in conformance with all applicable premarket notification
or premarket approval requirements established by the U.S. Food and Drug Administration
(FDA) unless otherwise exempted from such requirements.
(c)
Each device manufacturer who manufactures a needleless
system device or sharps device with engineered sharps injury protection and
who desires to register the device for the first time with the department
shall apply for registration in accordance with the procedures found in §96.303
of this title (relating to Registration Procedures).
(d)
If a device manufacturer introduces more than one needleless
system device or sharps device with engineered sharps injury protection into
commerce, the manufacturer shall register each device separately in order
for the device to be included on a list maintained by the department.
(e)
Each sharps device with engineered sharps injury protection
that is the subject of the department's device registration application shall
contain physical attributes consistent with those recognized as effective
for engineered sharps injury protection, as defined in §96.101(9) of
this title (relating to Definitions).
(f)
The department may accept reports from authorities in other
jurisdictions, including the FDA, to determine the extent of compliance with
these sections and with the provisions of Health and Safety Code, Chapter
81, Subchapter H.
(g)
The department shall register a needleless system device
or sharps device with engineered sharps injury protection that meets the requirements
of these sections.
(h)
Registration of a needleless system device or sharps device
with engineered sharps injury protection by the department does not constitute
an endorsement or recommendation of such device.
(i)
Registration certificates shall not be transferable from
one device to another or from one device name to another. Any request for
transfer of registration due to a change in ownership shall be made pursuant
to the requirements in subsection (l) of this section.
(j)
All device registration certificates shall expire on December
31, 2001 and annually thereafter.
(k)
Renewal of registration.
(1)
Upon expiration of a device registration, the registration
may be renewed by filing an application for renewal on a form prescribed by
the department, accompanied by the appropriate renewal fee.
(2)
The renewal registration certificate shall be valid through
December 31st of the year issued.
(3)
The appropriate registration renewal form and renewal fee
for each device should be submitted to the department not later than 30 days
following the expiration date of the current device registration in order
to maintain the device on the department's list of existing needleless system
devices and sharps devices with engineered sharps injury protection.
(4)
The department shall renew the registration of a needleless
system device or sharps device with engineered sharps injury protection following
receipt of the appropriate renewal form and renewal fee.
(l)
The device manufacturer shall notify the department in
writing of any change that would render the information required in the initial
registration application no longer accurate. Upon receipt of a written notification
involving a change, the department may update the information contained in
its list of needleless system devices and sharps devices with engineered sharps
injury protection in order to reflect the change.
§96.401.Sharps Injury Log.
(a)
The chief administrative officer for each facility within
a governmental unit shall report, as required by this section, each employee,
as defined in §96.101(7) of this title (relating to Definitions), who
sustains a contaminated sharps injury, as defined in §96.101(5) of this
title. The chief administrative officer of the governmental unit may designate
an employee for each facility within the governmental unit to serve as the
reporting officer.
(b)
Information concerning each contaminated sharps injury
shall be recorded in a written or electronic sharps injury log which shall
be maintained by a governmental unit, in accordance with Health and Safety
Code, Chapter 81, Subchapter H, and this chapter.
(c)
The following information must be recorded in the sharps
injury log:
(1)
name and address of facility where injury occurred;
(2)
name and phone number of the chief administrative officer
or reporting officer;
(3)
date and time of the injury;
(4)
age and sex of the injured employee;
(5)
type and brand of sharp involved;
(6)
original intended use of the sharp;
(7)
whether the injury occurred before, during, or after the
sharp was used for its original intended purpose;
(8)
whether the exposure was during or after the sharp was
used;
(9)
whether the device had engineered sharps injury protection,
as defined in §96.101(9)(A) and (B) of this title (relating to Definitions),
and if yes, was the protective mechanism activated and did the exposure incident
occur before, during, or after activation of the protective mechanism;
(10)
whether the injured person was wearing gloves at the time
of the injury;
(11)
whether the injured person had completed a hepatitis B
vaccination series;
(12)
whether a sharps container was readily available for disposal
of the sharp;
(13)
whether the injured person received training on the exposure
control plan during the 12 months prior to the incident;
(14)
the involved body part;
(15)
the job classification of the injured person;
(16)
the employment status of the injured person;
(17)
the location/facility/agency and the work area where the
sharps injury occurred; and
(18)
a listing of the implemented needleless systems and sharps
with engineered sharps injury protection for employees available within the
governmental entity.
(d)
Information contained in subsection(c)(1) - (17) of this
section concerning each contaminated sharps injury shall be reported not later
than ten working days after the end of the calendar month in which it occurred.
(e)
A chief administrative officer for each facility within
a governmental unit or the designee shall report the contaminated sharps injury
to the local health authority where the facility is located. The local health
authority, acting as an agent for the Texas Department of Health (department),
shall receive and review the report for completeness, and submit the report
to the department. If no local health authority is appointed for the jurisdiction
where the facility is located, the report shall be made to the regional director
of the Texas Department of Health (department) regional office in which the
facility is located.
(f)
A contaminated sharps injury shall be reported on the department's
Contaminated Sharps Injury Reporting Form or through an electronic means established
by the department. Copies of the Contaminated Sharps Injury Reporting Form
can be obtained on the Internet at http://www.tdh.state.tx.us/ideas/report/sharps.htm
or from the Texas Department of Health Public Health Regional offices.
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 July 27, 2000.
TRD-200005195
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: March 10, 2000
For further information, please call: (512) 458-7236
Subchapter C. ENFORCEMENT
25 TAC §137.26
The Texas Department of Health (department) adopts new §137.26,
concerning the regulation of birthing centers without changes to the proposed
text as published in the March 17, 2000, issue of the
Texas Register
(25 TexReg 2291), and therefore the section will not
be republished.
New §137.26 implements certain provisions of Senate Bill 1232, 76th
Legislature, 1999, which grants the department the authority to appoint a
monitor for a center to ensure compliance with Health and Safety Code Chapter
244, when the center's failure to comply with Chapter 244 creates a serious
threat to the health and safety of the public. The rule places the cost of
a monitor on the birthing center, and clarifies who may be appointed as a
monitor, qualifications, and the purpose of a monitor. The rule language was
developed by an ad hoc advisory committee convened by the department to implement
the statutory language of §244.006(b).
No comments were received on the proposal during the comment period.
The new section is adopted under Health and Safety Code, Chapter
244, which authorizes the department to appoint a monitor for a center to
ensure compliance with Health and Safety Code Chapter 244, when the center's
failure to comply with Chapter 244 creates a serious threat to the health
and safety of the public; and Health and Safety Code, §12.001, which
provides the Texas Board of Health (board) with the authority to adopt rules
for the performance of every duty imposed by law on the board, the department,
and commissioner of health.
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 July 27, 2000.
TRD-200005197
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: March 17, 2000
For further information, please call: (512) 458-7236
Subchapter E. DOG AND CAT STERILIZATION
25 TAC §169.101
The Texas Department of Health (department) adopts an amendment
to §169.101 concerning the expiration date of the terms of office for
the members of the Animal Friendly Advisory Committee without changes to the
proposed text published in the April 14, 2000, issue of the
Texas Register
(25 TexReg 3164), and therefore, the section will not
be republished.
The section is amended to change the expiration date from September 1 to
January 31, making it conform with the statute which created the committee,
Health and Safety Code, §828.015.
No comments were received on the proposal during the comment period.
The amendment is adopted under the Health and Safety Code, §828.015,
which provides for the appointment of an Animal Friendly Advisory Committee;
and §12.001, which provides the Texas Board of Health (board) with the
authority to adopt rules for the performance of every duty imposed by law
on the board, the department, and the commissioner of health.
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 July 27, 2000.
TRD-200005194
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: April 14, 2000
For further information, please call: (512) 458-7236
Subchapter C. TEXAS ASBESTOS HEALTH PROTECTION
25 TAC §§295.31, 295.32, 295.63
The Texas Department of Health (department) adopts amendments
to §§295.31 and 295.32 and new §295.63 concerning authority
of the department to administer and enforce the federal Asbestos Hazard Emergency
Response Act (AHERA, 40 CFR, Part 763 Subpart E, excluding appendices) without
changes to the proposed text as published in the June 2, 2000, issue of the
Amended §295.31 expands the scope of the rules to include administration
and enforcement of AHERA by the department. Amended §295.32 adds one
new definition. New §295.63 transfers authority from U.S. EPA to the
department for administration and enforcement of AHERA.
No comments were received regarding the proposal during the comment period.
The amendments and new section are adopted under Texas Civil
Statutes, Article 4477- 3a, §12(c), which provides the Board of Health
(board) with the authority to adopt rules specifying performance standards
at least as stringent as applicable federal standards, and the Health and
Safety Code, §12.001, which provides the board with the authority to
adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner of health.
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 July 27, 2000.
TRD-200005196
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: August 16, 2000
Proposal publication date: June 2, 2000
For further information, please call: (512) 458-7236
Chapter 409.
MEDICAID PROGRAMS
The Texas Department of Mental Health and Mental Retardation (TDMHMR)
adopts the repeals of §409.1, §409.2, §409.3, §409.5,
and §409.7 of Chapter 409, Subchapter A, concerning general reimbursement
methodology for all medical assistance programs; §409.213 of Chapter
409, Subchapter F, concerning case management program requirements; and §409.256
of Chapter 409, Subchapter G, concerning case management for persons with
severe and persistent mental illness. The repeals are adopted without changes
to the proposal as published in the April 14, 2000, issue of the
Texas Register
(25TexReg3164-3166).
Sections 409.1, 409.3, 409.5, and 409.7 are repealed because they are duplicative
of 1 TAC §§355.701, 355.703, 355.705, and 355.707. Section 409.2
is repealed because it conflicts with 1 TAC §355.702, which was amended
effective September 1, 1999. Sections 409.213 and 409.256, both relating to
right to appeal, are repealed because provisions regarding fair hearings for
Medicaid recipients of service coordination (previously referred to as case
management) are described in 25 TAC §412.464. The two sections were inadvertently
omitted when TDMHMR repealed the subchapters concerning case management.
No public comment on the proposal was received.
Subchapter A. GENERAL REIMBURSEMENT METHODOLOGY FOR ALL MEDICAL ASSISTANCE PROGRAMS
25 TAC §§409.1 - 409.3, 409.5, 409.7
The repeals of the sections are adopted under the Texas Health
and Safety Code, §532.015(a), which provides the Texas Board of Mental
Health and Mental Retardation with broad rulemaking authority; the Texas Government
Code, §531.021(a), and the Texas Human Resources Code, §32.021(a),
which provide HHSC with the authority to administer the federal medical assistance
(Medicaid) program in Texas; Acts 1995, 74th Legislature, Chapter 6, §1,
(Senate Bill 509), which clarifies the authority of HHSC to delegate the operation
of all or part of a Medicaid program to a health and human services agency;
and the Texas Human Resources Code, §32.021(c), which provides an agency
operating part of the Medicaid program with the authority to adopt necessary
rules for the proper and efficient operation of the program.
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 July 31, 2000.
TRD-200005285
Charles Cooper
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: August 20, 2000
Proposal publication date: April 14, 2000
For further information, please call: (512) 206-5216
25 TAC §409.213
The repeal of this section is adopted under the Texas Health
and Safety Code, §532.015(a), which provides the Texas Board of Mental
Health and Mental Retardation with broad rulemaking authority; the Texas Government
Code, §531.021(a), and the Texas Human Resources Code, §32.021(a),
which provide HHSC with the authority to administer the federal medical assistance
(Medicaid) program in Texas; Acts 1995, 74th Legislature, Chapter 6, §1,
(Senate Bill 509), which clarifies the authority of HHSC to delegate the operation
of all or part of a Medicaid program to a health and human services agency;
and the Texas Human Resources Code, §32.021(c), which provides an agency
operating part of the Medicaid program with the authority to adopt necessary
rules for the proper and efficient operation of the program.
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 July 31, 2000.
TRD-200005286
Charles Cooper
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: August 20, 2000
Proposal publication date: April 14, 2000
For further information, please call: (512) 206-5216
25 TAC §409.256
The repeal of this section is adopted under the Texas Health
and Safety Code, §532.015(a), which provides the Texas Board of Mental
Health and Mental Retardation with broad rulemaking authority; the Texas Government
Code, §531.021(a), and the Texas Human Resources Code, §32.021(a),
which provide HHSC with the authority to administer the federal medical assistance
(Medicaid) program in Texas; Acts 1995, 74th Legislature, Chapter 6, §1,
(Senate Bill 509), which clarifies the authority of HHSC to delegate the operation
of all or part of a Medicaid program to a health and human services agency;
and the Texas Human Resources Code, §32.021(c), which provides an agency
operating part of the Medicaid program with the authority to adopt necessary
rules for the proper and efficient operation of the program.
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 July 31, 2000.
TRD-200005287
Charles Cooper
Chairman, Texas MHMR Board
Texas Department of Mental Health and Mental Retardation
Effective date: August 20, 2000
Proposal publication date: April 14, 2000
For further information, please call: (512) 206-5216
Subchapter O. ENROLLMENT OF MEDICAID WAIVER PROGRAM PROVIDERS
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Chapter 96.
BLOODBORNE PATHOGEN CONTROL
Chapter 137.
BIRTHING CENTERS
Chapter 169.
ZOONOSIS CONTROL
Chapter 295.
OCCUPATIONAL HEALTH
Part 2.
TEXAS DEPARTMENT OF MENTAL HEALTH AND MENTAL RETARDATION
Subchapter F. CASE MANAGEMENT PROGRAM REQUIREMENTS
Subchapter G. CASE MANAGEMENT FOR PERSONS WITH SEVERE AND PERSISTENT MENTAL ILLNESS
Chapter 419.
MEDICAID STATE OPERATING AGENCY RESPONSIBILITIES