Taken from http://www.sos.state.tx.us/texreg/archive/December111998/adopted/health-services.html#282
Chapter 100. Immunization Registry
25 TAC §§100.1-100.11
The Texas Department of Health (department) adopts new §§100.1-100.11 concerning the creation
of an immunization registry and for reporting requirements. Sections 100.1-100.9 and 100.11 are
adopted with changes to the proposed text as published in the August 7, 1998, issue of the Texas
Register (23 TexReg 8018). Section 100.10 is adopted without change and therefore will not be
republished.
These rules will implement House Bill 3054 passed by the 75th Legislature, 1997, which enacted
Chapter 900, adding Health and Safety Code §§161.007-161.009 requiring the department to establish
an immunization registry. The rules implement the legislative intent to protect the confidentiality
of patients, insure that their participation is only with informed consent and permit their
withdrawal from the registry. At the same time the registry is designed to implement the legislative
intent of establishing a repository of accurate, complete, and current immunization records to be
used in aiding, coordinating, and promoting efficient disease prevention efforts. The legislature
specifically envisioned use of the registry to provide notices by mail, telephone, personal contact,
or other means to parents.
Specifically, the sections define terms used in this chapter; address the criteria for inclusion
of information and its confidentiality; the responsibilities of providers and payors; the effect of
withdrawing consent; the information to be reported to the registry; data quality assurance; the
responsibilities of managed care, health maintenance organizations, and insurance companies; reports
back to providers; exchange of information between the department and providers; and use of registry
data for school and day care enrollment.
The department is making the following changes due to staff comments to clarify the intent and
improve the accuracy of the section.
Change: For clarity the term "shall" is used throughout the rules where action or
activity is mandated or required. In §100.3(a) it is used in new language. It is substituted for
"will" in §§100.4(a) twice, (b), (c), 100.5(a),(b),(c),(e),(f),(h), 100.7(b), the
caption to 100.8, 100.8(a), (b) twice, 100.9(b), 100.11(a),(b),(c). It is substituted for
"should" in §100.5(d). It is substituted for "must" in §100.5(d).
Change: Concerning §§100.1, 100.2(b), the age was changed from "21" to "18"
to properly reflect the legal age of adulthood. In §100.5(a), the term "21st" was changed
to "18th".
Change: Concerning §100.1, the phrase "and are used interchangeably within the rules"
was changed in the following definitions: "child", "consent", "immunization
history", and "parent" due to clarifications in these definitions and for easier
reading of the rules.
Change: Concerning §100.1, the term " patient, client, and child" was changed to
"child" for easier reading of the rules. This change occurs in §§100.2(a) twice, and
100.2(a)(4).
Change: Concerning §100.1, the term "consent or parental consent" was changed to
"consent" for easier reading of the rules. The phase "parental consent" was
shortened to "consent" to conform with the new definition. This change occurs in
§§100.1, 100.2(a), 100.2(a)(5) twice, 100.3(e), 100.4(a), 100.5(b), (d), (k) twice, 100.7(b), and
100.8(a).
Change: Concerning §100.1, the definition of the term "consent" was clarified for
easier reading of the rules.
Change: Concerning §100.1, the term and definition of "division" was deleted because
it was not used.
Change: Concerning §100.1, the term "parent, managing conservator or guardian" was
changed to be included in the definition of "Parent" for easier reading of the rules. This
change occurs in §§ 100.1(2), 100.1(8), 100.2(a), 100.2(a)(4), (b) and (d), 100.3(c), 100.4(a),(b)
twice, (c), (c)(4), (c)(6), 100.5(g), and 100.6(b), managing conservator or guardian were also
deleted.
Change: Concerning §100.1, the term "immunization history and record" was split and
redefined as "immunization history" and "immunization record" to distinguish
between information going into and being released from the registry and for easier reading of the
rules. The term "immunization history" was substituted in the following: for record in
§§100.1(2), 100.1(5); for "information" in §§100.2(a), 100.2(a)(4), 100.2(a)(1),
100.2(b), 100.3(d), 100.4(b) four times, 100.5(b) twice,(d), (e), and (k), 100.6(a), 100.7(b), and
100.8(a); in §100.2(a)(1) for "demographic information and immunization record;" in
§100.2(a)(3) for "information on my child", in §100.1(7) for "histories;" for
"record" or "a record" in §§100.1(2), 100.1(5), 100.5(a), 100.5(c) twice,
100.5(d), 100.5(g)(3)(E) and (j), 100.6(b)(1),(2),and (3), 100.7(a) and (b), and 100.8(a); in
§100.5(e) for "vaccine administered;" and in §100.8 caption for "data."
Change: The term "immunization record" was used to signify information released from
the registry, to conform with its definition and to be consistent throughout. The term was used in
new language in §100.1(2), and as a substitute for the term "information" in
§§100.2(a)(2) and (a)(3).
Change: Concerning §100.1, the word "Registry" was made lower case to be consistent
with other definitions and for easier reading of the rules.
Change: Concerning §100.1, the definition of the term "immunization registry" was
clarified for easier reading of the rules.
Change: Concerning §100.2(a), the word "section" was changed to "subsection"
to be more precise and for easier reading of the rules.
Change: Concerning §100.2(a), for consistency, the term "health plan" or "health
plans" were used throughout to conform with its definition, in place of lengthier phrases. In
§§100.2(a) and 100.5(e) it was used in new language. In the caption to §100.3 it was substituted
for "Health Plans and Insurance Companies." In §100.3(b) it was substituted twice for
"Insurance companies health maintenance organizations or other organizations." It was
substituted in §100.5(k) for "insurance company, health maintenance organization or other
organization that pays or reimburses a claim or encounter for administration of an
immunization." It was also substituted in §100.5(k) for "third party payor." In the
caption to §100.8 it was substituted for "Texas Managed Care organizations, Texas Health
Maintenance Organizations and other Texas Insurers." In §100.8(a) it was substituted for
"Organizations."
Change: Concerning §100.2(a), the following language: "§100.4 of this title (relating to
Withdrawal of Consent)" was substituted for: "paragraph (4) of this section" to be a
more precise cross-reference and for easier reading of the rule.
Change: Concerning §100.2(a), the following language: "sent to a health plan or the
department to be" was added to be more precise and for easier reading of the rule.
Change: Concerning §100.2(a), grammar change "of a" to "from the" was made.
This was due to a change in the definition.
Change: Concerning §100.2(a), "sent to the health plan or the department to be" was
added for clarification.
Change: Concerning §100.2(a), the word "subsection" was changed to "section"
to be more precise and for easier reading of the rules.
Change: Concerning §100.2(a)(2), the words "Department of Health's" were added to be
more precise and for easier reading of the rules.
Change: Concerning §100.2(a)(2), the words "immunization records on my child to a parent of
the child" replace "information concerning my child's immunizations to myself" to be
more precise and for easier reading of the rules.
Change: Concerning §100.2(a)(4), was renumbered as §100.2(a)(3) due to the deletion of proposed
§100.2(a)(3).
Change: Concerning §100.2(a)(4), the last five sentences were deleted since the same information
is covered in §100.4.
Change: Concerning §100.2(a)(5), this subsection was added using language from the previous
§100.2(a)(4) to separate the information being presented. The words "or if the status of
consent is unknown" were added to be more precise.
Change: Concerning §100.2(d) and (e), the words "health care" were removed to match
the changed definition of "provider."
Change: Concerning §100.3(a), this was added to clarify provider's responsibility to report if
they are not reimburse for an immunization. Subsequent subsections were relettered.
Change: Concerning §100.3(b), the words "After December 31, 1998, an insurance company, a
health maintenance organization, or another organization" were removed and replaced with
"a health plan" for simplification. The words "an immunization history" were
replaced by "immunizations from only the current claim submitted" for clarification. The
words "if consent has been obtained" was added. The words "pay" and
"reimburse" were made plural to match new wording. This occurred in three places in the
paragraph. The words "On or before December 31, 1998, an insurance company, a health
maintenance organization, or another organization that pay or reimburse a claim for an immunization
of a person younger than 18 years of age may provide an immunization history to the department"
were removed to be consistent with definition changes. The words "forward consented
immunization information to the registry" was added for simplification and the following was
deleted: "must document parental consent for inclusion in the registry before the record is
submitted to the department. Insurance companies, health maintenance organizations or other
organizations that pay or reimburse a claim will develop a system for documentation of consent
status and develop systems or forms necessary to gather required information for the immunization
registry. The payor is not required to send the department records where parental consent has been
denied." This change was made to allow health plans to establish their own means of assuring
that consent exists as required by law.
Change: Concerning §100.3(c), the word "each" was replaced by "a" to
simplify the process. The words "their child's" was added to the sentence for
clarification.
Change: Concerning §100.4(a), the words "described in §100.2(a)(4) of this title (relating
to Inclusion of Information and Confidentiality" were removed and were replaced by the word
"consent" to be a more precise definition of consent. Moved the word "entire"
from before the word "child's" to after the word for clarification. The words
"Immunization Division" were removed and replaced it with "immunization
registry" due to the removal of the term "Division" in §100.1, definitions.
Change: Concerning §100.4(b), the words "history to the department or health plan for
inclusion in the immunization registry" were added for clarification.
Change: Concerning §100.4(b) the term "statewide" was deleted as redundant.
Change: Concerning §100.4(c), the words "mailed to the Texas Department of Health,
Immunization Registry, 1100 West 49th Street, Austin, Texas 78756 and" were added to replace
the previous deletion of the address in §100.2(a)(4).
Change: Concerning §100.4(c)(5), the words "where the parent can receive a confirmation
notice" were substituted for clarification, and "for confirmation notice" was
deleted.
Change: Concerning §100.5(a), the word "All" was removed and replaced with the word
"Information on" for clarification. The words "after the effective date of these
rules" was removed since the effective date of the statute is the same as the effective date of
the rules (January 1, 1999). The words "for which there is consent shall" were added to
emphasize that only consented information be sent to the immunization registry. The words "and
archived" were added to reflect accurately the disposition of the records.
Change: Concerning §100.5(b), the words "following: last name, first name, date of birth,
gender and address of the child who is immunized; name of parent, guardian, or managing conservator
and relationship to child; mothers maiden name for record matching; vaccine administered; dose or
series number; vaccine lot number; and, manufacturer of the vaccine administered" were removed
and replaced with "information listed in subsections (g)(2) and (3) of this section" to be
more precise and for easier reading of the rule.
Change: Concerning §100.5(c), this subsection was added using existing language from §100.5(b).
Subsequent subsections have been relettered.
Change: Concerning §100.5(d), the word "the record should" was changed to
"immunization shall" for clarification. The second sentence was removed and replaced with
the language from the Health and Safety Code §161.007(d).
Change: Concerning §100.5(e), the words "Providers and health plans may contact the
department (1100 West 49th Street, Austin, Texas 78756, 1-800-252-9152) to establish a provider
number and a system of reporting" were added for clarification.
Change: Concerning §100.5(g), the words "health plan" were added for clarification.
Change: Concerning §100.5(g)(1), (2), and (3) the words "must include" was added for
clarification.
Change: Concerning §100.5(g)(3), the words "if know" were added for clarification.
Change: Concerning §100.5(g)(3)(E), the words "has been" was replaced by
"is" to change verb tense. The words as "defined as" were changed to is to
change verb tense.
Change: Concerning §100.5(h), the words "be reported" were added for clarification.
Change: Concerning §100.5(j), the words "from the parent" were added for
clarification. The word "historical" was replaced by "all" for clarification.
Change: Concerning §100.5(k), the words "to the department" were added for
clarification.
Change: Concerning §100.5(k) the term "state-wide" was deleted as redundant.
Change: Concerning §100.6(a), the word "was" was replaced by "were" to make
it more grammatical.
Change: Concerning §100.6(a)(4), a period was added to the end of the sentence.
Change: Concerning §100.6(b), a colon was replaced by a period.
Change: Concerning §100.6(a), a phone number was provided for the convenience of the public.
Change: Concerning §100.6(b)(3), the words "as specified in §100.4 of this title (relating
to Withdrawal of Consent)" was added for clarification.
Change: Concerning §100.7(a), the words "of children whose names appear in the
registry" were added for clarification.
Change: Concerning §100.8(a), a period was added to the sentence.
Change: Concerning §100.9(b), the words "The provider, health plan and department"
were removed and replaced with "Any user of the immunization registry" for clarification.
Change: Concerning §100.11(c), the abbreviation "ID" was replaced with
"identification number" for clarification.
The following comments were received concerning the proposed rules. Following each comment is the
departments response and any resulting changes.
Comment: One commenter, regarding the preamble, questions the cost estimate of $1.00 per patient
encounter where an immunization is provided and $500 a year of participation for the average
insurer. The commenter believes this is an underestimate.
Response: The department agrees in part and disagrees in part. The estimate that the commenter
refers to is an estimate based on the amount of time to inform a patient about the registry, receive
a signature, and submit consented data. The department recognizes that reporting may cost some
organizations more than others depending how, or if, information was collected in the past, and any
changes which may be made to existing systems. No change was made as a result of this comment.
Comment: Concerning §100.1, one commenter suggested alphabetizing the definitions.
Response: The department agrees and has alphabetized the definitions.
Comment: Regarding §100.1(3), renumbered as §100.1(9), twenty-six comments stated objections to
the department defining all providers as agents for the purposes of the immunization registry.
Response: The department agrees. The suggested language was removed from the rules, which is
renumbered as §100.1(9).
Comment: Concerning §100.1(4), renumbered as §100.1(10), one commenter believes that the
definition of "user" is lax and appears to intentionally remove government employees from
accountability.
Response: The department disagrees. The department allows access to those users defined in the
Health and Safety Code, §161.008(c)(2). No change was made as a result of this comment.
Comment: Concerning §100.1(6), renumbered as §100.1(11), one comment was received recommending
the definition of "vaccine" needs to be redefined and the commenter suggests listing all
vaccines to be tracked.
Response: The department agrees in part. The definition of vaccine has been redefined and changes
were made to renumbered §100.1(11). As new vaccines become available and medical standards change
accordingly, the registry may be modified. Listing all vaccines in the rules would not allow for the
addition of new vaccines without rule making.
Comment: Concerning §100.1(8), now renumbered as §100.1(4), one commenter suggests the
definition of a health plan needs to be clarified as to whether or not third party administrators
and self funded employers are included within the meaning of "health plan."
Response: The department disagrees and responds that the rules are based on the definition for a
health plan from the language used in the Health and Safety Code, §161.007(c), which states that
any organization that pays or reimburses a claim for an immunization shall provide information. No
change was made as a result of this comment. This term was renumbered §100.1(4)
Comment: Concerning §100.1(5), (9), (10), and (11), one commenter suggested the department end
each definition with "...are used interchangeably within the rules."
Response: The department has deleted this phrase from all definitions.
Comment: Concerning §100.2(a) and §100.5(a), twenty-five comments were received with objections
to the length of time the department plans to store data.
Response: The department disagrees and responds that the Health and Safety Code, §161.008 states
that the registry must contain information on the immunization history on each person younger than
18 years of age. The law does not specify the department destroy the data following the child's 18th
birthday. Most universities require proof of immunizations prior to enrollment. The department has
numerous requests each year from college students attempting to track down this information. After
age 18, the department will remove the record from the immunization registry and archive the data.
No change was made as a result of this comment.
Comment: Concerning §100.2(a)(1), one commenter asks under what statutory authority is the
department collecting demographic information.
Response: The department disagrees and responds that the statutory authority used for collecting
demographic information is found in Health and Safety Code, §161.007(d) which states the report
shall be in a format prescribed by the department. It is also implied in the Health and Safety Code,
§161.007(e) which states the department may use the registry to provide notices by mail, telephone,
personal contact, or other means. This task could not be accomplished without demographic
information. Demographic information is also necessary for matching and the avoidance of mistaken
identity. No change was made as a result of this comment.
Comment: Concerning §100.2(a), one commenter states that this section does not authorize or
allow a parent who did not sign a consent form, access to copies of immunization records. Also,
children 18 or older should be authorized to receive copies of their own records.
Response: The department agrees. In §100.2(a)(1), the word "myself" was changed to
"the parent" in §100.2(a)(2). Although the statute does not expressly allow for release
of information to children in the registry when the child becomes 18 years old or older; under the
Open Records Act, Government Code, §552.023 such a person would have a special right of access to
their own immunization record.
Comment: Concerning §100.2(a)(2)(C), one commenter suggested the word "to" should be
changed to "of."
Response: The department disagrees. The word "to" was used in the Health and Safety
Code, §161.008(c)(2). No change was made as a result of this comment.
Comment: Concerning §100.2(a)(2)(D), (E), and (G), twenty-eight comments were received stating
objections to release of information to the Commissioner of Health or designee, past or present
health plan, and the Texas Department of Health and Human Services.
Response: The department agrees with the comments. The language was deleted from §100.2(a)(2).
Comment: Concerning §100.2(a)(3), twenty-six commenters object to the re-release of data to
providers who both administer and promote vaccine.
Response: The department agrees. Proposed §100.2(a)(3) was deleted.
Comment: Concerning §100.2(a)(3), twenty-six comments were received with concerns about the
re-release of data to other state registries and concerns that this will allow release of
information to a national registry in the event one is created.
Response: The department agrees and responds that the legislation did not address re-release to
other state registries, therefore the language in proposed §100.2(a)(3) has been deleted.
Comment: Concerning §100.2(a)(4), renumbered now as §100.2(a)(3), one commenter feels that when
a request for withdrawal of a record is received by the department from the parent, it should also
be forwarded to the health plan.
Response: The department disagrees. The registry does not track the health plan with whom the
child is affiliated. It is the responsibility of the parent to notify the provider that consent has
been withdrawn and no further records should be forwarded to the department. No change was made as a
result of this comment.
Comment: Concerning §100.2(a)(5) renumbered as §100.2(a)(4), one commenter believes the
department can not be trusted to carry out the task of completely deleting a child's entire record
upon the request of the parent.
Response: The department disagrees and responds that any parent who suspects that their child's
records have not been deleted can verify deletion by asking the department, or any authorized user,
to check their child's information in the registry. No change was made as a result of this comment.
Comment: Concerning §100.2(a)(5) renumbered as §100.2(a)(4), one commenter suggested the
following words should be added to the end of the paragraph "or if the status of parental
consent is unknown."
Response: The department agrees and has added the suggested language to renumbered §100.2(a)(4).
Comment: Concerning §100.2(a)(5) renumbered as §100.2(a)(4), one commenter states there is
reference to a signature block, but it is unclear to what document this is referring.
Response: The department disagrees and responds that the context makes clear that the signature
block relates to the parental consent statement. Providers may develop their own forms, using the
parental consent language defined in the rules, however, the form must include a signature block or
place for the parent signature. No change was made as a result of this comment.
Comment: Concerning §100.2(a)(5) renumbered as §100.2(a)(4), one commenter asked how consent
will be communicated between the provider and the health plan. The commenter also states that this
creates a potential for either duplication or inadvertent lack of reporting.
Response: The department responds that §100.3(d) renumbered as §100.3(e), states that the
written consent for inclusion shall be maintained with the provider. If the provider has consent and
does not submit the immunization to a health plan, they should indicate that consent has been
received when the record is forwarded to the department, see Health and Safety Code, §161.003(c).
If the provider submits the immunization history to a health plan it is the responsibility of the
health plan and the provider to decide how to communicate the consent status. Section 100.3(a)
renumbered as §100.2(b), states that only the consented immunization histories should be forwarded
to the department. No change was made as a result of this comment.
Comment: Concerning §100.2(b), twenty-eight comments were received with objections to consent
obtained on a child's birth certificate and previous consent procedures utilizing the Vaccine
Information Statements (VIS).
Response: The department disagrees with the first comment and agrees with the second comment.
Immunizations begin at birth. For those parents that desire for their children to be included in the
registry, it is important that we capture as many immunizations as possible. Parents make many
important decisions at the time of birth. The department will provide informational materials to
obstetricians for dissemination prior to the birth of the child. The consent forms the commenters
refer to are the forms used prior to the legislation requiring parental consent. The new forms have
the parental consent language for the registry separate from the consent for the immunization. The
department has begun distribution of the new forms, with instructions to destroy and recycle
outdated forms. The parental consent language is based on the most current consent language at the
time of printing. No change was made as a result of this comment.
Comment: Concerning §100.2(b), twenty-six comments were received stating objections to the
consent being required "one time only."
Response: The department disagrees. Health and Safety Code, §161.007(a), states that the
department by rule shall develop guidelines for requiring the written consent of the parent,
managing conservator, or guardian. It does not specify that parents must re-sign consent forms at
each immunization visit. Parents have the option to rescind their consent at any time. No change was
made as a result of this comment.
Comment: Concerning §100.2(b), one commenter states that gaining consent on the birth
certificate is an excellent approach, but it will only benefit the health plan if they have access
to the information.
Response: The department disagrees that health plans should have access to the information. The
Health and Safety Code §161.008(c)(2) does not allow the department to release consent status to
the health plans. No change was made as a result of this comment.
Comment: Concerning §100.2(d), one commenter states that parents who have lawful medical or
religious exemptions could be subject to routine warning letters about their child being "past
due" for immunizations.
Response: The department disagrees. Private providers who do their own recall will now have the
ability to know who has medical or religious exemptions. A contact "yes" or "no"
flag is available in the state immunization registry. The flag can be set to "no contact"
if the child's parents do not wish to be contacted for recall and reminder and the department is
notified of that fact. No change was made as a result of this comment.
Comment: Concerning §100.2(e), two commenters requested that "good faith" be defined.
Response: The department disagrees with the commenter. The law defines "good faith" as
an intangible and abstract quality with no technical meaning or statutory definition, and it
encompasses, among other things an honest belief, the absence of malice and the absence of design to
defraud. The definition of "good faith" was not added to §100.1. No change was made as a
result of this comment.
Comment: Concerning §100.2(a)(2)(G), one commenter objects to release of immunization data to a
health care plan in which a child is or was enrolled.
Response: The department agrees with the comment. The language was deleted from the rules.
Comment: Concerning §100.3(a) renumbered as §100.3(b), one comment was received about the
communication process for record transfer between provider and the health plan. The health plans
believe the law and the rules create a "broken information loop."
Response: The department disagrees and responds that the information flow the commenter refers to
is mandated by the law, Health and Safety Code, §161.007(d). No change was made as a result of this
comment.
Comment: Concerning §100.3(a) renumbered as §100.3(b), one commenter suggests "health
plan" be used in place of "insurance company."
Response: The department agrees. "Health plan" has been substituted each place an
"insurance company, a health maintenance organization or other organization that pays or
reimburses a claim" in §§100.3(b), 100.5(d) and (k), and section title of §100.8.
Comment: Concerning §100.3(c) renumbered as §100.3(d), one commenter feels this section,
requiring external systems supplying the immunization registry with data to contain a consent flag,
is not needed in the rules.
Response: The department disagrees. This rule states that external computer systems supplying
immunizations to the department must include a parental consent flag indicating parental consent.
Since only records flagged "yes" will be forwarded to the registry, this indicator flag
will allow external systems to query their databases and only send the registry records where the
indicator flag has been set to "yes." No change was made as a result of this comment.
Comment: Concerning §100.3(a) renumbered as §100.3(b), a commenter believes the paragraph
should be modified to read "vaccines must be administered by a licenced health care facility
and an individual licensed health care professional."
Response: The department disagrees. The definition of a provider is found in renumbered
§100.1(9) and is not necessary in this section of the rules. No change was made as a result of this
comment.
Comment: Concerning §100.3(c) renumbered as §100.3(d), one commenter states that maintaining a
system to document consent by the health plan could be cost prohibitive.
Response: The department disagrees and responds that a method or system for the documentation
consent status is necessary, but the precise method is up to the health plan. The health plans must
be able to separate the consented data from the non-consented data. Only the consented data can be
forwarded to the registry. No change was made as a result of this comment.
Comment: Concerning §100.3(c) renumbered as §100.3(d), one comment was received about
immunization registry linking with other unspecified databases and the need for "external
computer systems" to incorporate a computer field that indicates whether or not consent has
been obtained. The commenter feels the department should list external computer systems that can be
linked to the tracking system.
Response: The department disagrees. Insurance companies, private providers, managed care
organization, health maintenance organizations, public health and other billing vendors will be
supplying the department with immunization histories. An indicator field will be used by the
external systems to only supply the immunization registry with consented records. It is not feasible
to list all the external computer systems that will be supplying the immunization registry with
data. No change was made as a result of this comment.
Comment: Concerning §100.4(a), one commenter is concerned that only immunization information
will be deleted, leaving the department to maintain all other personal information in the files.
Response: The department agrees in part and responds §100.4(a) states the child's entire
history, which includes the immunization and identifying demographic information, will be removed
from the immunization registry. The wording of this subsection has been changed to clarify this
point.
Comment: Concerning §100.4(a), one commenter believes a copy of the confirmation of a withdrawal
letter, which is sent to the parent, should also be sent to the health plan.
Response: The department disagrees. The law does not allow the department to release information
to the health plans. No change was made as a result of this comment.
Comment: Concerning §100.4(c)(5), one commenter asks if the department intends to issue vaccine
notices and how that will affect fiscal implications.
Response: The department may assist providers with recall notices. Recall and reminder reports
will, for the most part, be generated by the providers. The provider may or may not choose to use
recall and reminder features. The department believes that dollars spent on immunizations and recall
are appropriately utilized, and that this use of the registry is authorized by Health and Safety
Code, §161.007(e). No change was made as a result of this comment.
Comment: Concerning §100.5, one commenter states that the rules do not appear to request any
information regarding negative reactions to specific vaccines.
Response: The department confirms this interpretation of the rules. The rules do not request any
information regarding negative reactions to specific vaccines. The registry is not designed to be a
medical record, only a database holding a list of vaccines administered to the child. The provider
is appropriately responsible to determine any contraindications to vaccinations. The registry does
include an "adverse reaction flag" which defaults to "no," but may be changed to
yes, if an adverse reaction is reported. The flag produces a reminder notice to the provider to
submit an adverse reaction report to the department. No change was made as a result of this comment.
Comment: Concerning §100.5(a), one commenter feels this rule leaves the door open for the
department to change or add other required vaccines.
Response: The department confirms this interpretation of the rules. The rules are left flexible
allowing the immunization registry the ability to add or change required vaccines as medical
standards change. No change was made as a result of this comment.
Comment: Concerning §100.5(b), and (f) renumbered as §100.5(g), one commenter feels the
information requested should be compatible with the required information on the Health Care
Financing Administration (HCFA) 1500 form.
Response: The department agrees in part with this comment. The information will be compatible
with most of the required information on the HCFA 1500, however, this form does not capture some of
the required information for the registry. No change was made as a result of this comment.
Comment: Concerning section §100.5(d) renumbered as §100.5(e), one commenter questions why
health plans must submit the immunization data within 25 days after the receipt from the provider
and when the data are received directly from the immunization provider they are given 30 days to
submit their information.
Response: The department responds immunizations are recommended at two month intervals during the
first 6 months of life. The insurance companies must forward the information to the department after
it is received from the provider. The department is concerned that the last doses will not be
recorded before the next series is due. The provider needs this information to appropriately assess
current immunization status. No change was made as a result of this comment.
Comment: Concerning §100.5(f)(2) renumbered as §100.5(g)(2), twenty-seven comments were
received stating objections to the amount of data the department is requiring for the registry.
Response: The department disagrees and responds that the Health and Safety Code, §161.008(a)
states: an immunization record is part of the immunization registry. "An immunization record
contains the: (1) name and date of birth of the person immunized; (2) dates of immunization; (3)
types of immunization administered; and (4) name and address of the health care provider
administering the immunization." The definition of an immunization record in the Health and
Safety Code refers to what a record consists of when released, in hard copy, from the registry. This
was never intended to be the only information the registry receives. The information provided in
this list is not enough to match records or adequately track a child's immunization history. If the
parent consents to participate in the registry, they consent for the tracking of the "required
fields". Children could be adversely affected, if decisions were made based on records that are
not accurate. No change was made as a result of this comment.
Comment: Concerning §100.5(f)(2)(C) renumbered as §100.5(g)(2)(C), twenty-seven comments were
received stating objections to social security number being labeled in the rules as "if
available", not "optional."
Response: That department disagrees and responds that a record will be accepted without a social
security number for the child if this number is not available to the provider. This information is
very important in creating a unique record. The department needs the social security number to
assure that immunization records are reliable and matched to the appropriate child. No change was
made as a result of this comment.
Comment: Concerning §100.5(f)(3) renumbered as §100.5(g)(3), one commenter asks if the vaccine
type, date of vaccine, vaccine lot number, dose or series number and name of manufacturer are
included on the immunization records requested by parents.
Response: The department responds that only the vaccine type, date of vaccine and dose and series
number are provided on the reports requested by parents. The vaccine lot number and manufacturer are
provided only to the provider. No change was made as a result of this comment.
Comment: Concerning §100.5(f)(3)(D) renumbered as §100.5(g)(3)(D), one commenter states that if
this section applies to health plans it should be restated to read "dose or series number (if
known)."
Response: The department agrees. The language was added to the section.
Comment: Concerning §100.5(f)(3) renumbered as §100.5(g)(3), one commenter questioned the
accuracy and availability of data provided by the health plans. The commenter also stated concern
about the ability of department to match records. Also, concern that the health plan does not
receive much of the "required" information, such as vaccine lot number, dose and series
numbers.
Response: In response to this concern, the department utilizes sophisticated software which
matches imported records. With all required information listed in §100.5(g)(2) and (3), the
registry can accurately match records. The health plan cannot forward consented information to the
registry that it does not receive from the provider. No change was made as a result of this comment.
Comment: Concerning §100.5(f) renumbered as §100.5(g), one commenter is concerned that claims
billing systems are not set up to automatically capture the level of detailed information required
for the registry. Adding fields and modifications to pre-existing programs is expensive and time
consuming.
Response: The department responds that the mandate to receive immunization histories from health
plan billing systems was determined by the Health and Safety Code, §161.007(c). No change was made
as a result of this comment.
Comment: Concerning §100.5(g) renumbered as §100.5(h), one commenter states that the department
needs to clarify how to report evidence of immunity to vaccine preventable disease.
Response: The department responds that the registry will be modified to accept evidence of
immunity in lieu of immunization. Until the registry is modified, specific guidelines for reporting
can not be provided. No change was made as a result of this comment.
Comment: Concerning §100.5(j) renumbered as §100.5(k), one commenter asks if this section
pertains to information submitted by providers when the child does not have any type of health
coverage.
Response: The department confirms this interpretation of the rules. This section applies to
immunizations that are not billed to a health plan. No change was made as a result of this comment.
Comment: Concerning §100.6(a), twenty-seven comments were received with objections to the use of
data obtained prior to the effective date of these rules.
Response: The department disagrees. Many parents throughout the state believe, and are expecting,
the department to be collecting immunization data for their children. All records, for which consent
status could not be determined, obtained through the Bureau of Vital Statistics were deleted in June
1998. No change was made as a result of this comment.
Comment: Concerning §100.6(a), one commenter requests no deleting of any currently loaded public
data because the registry is only worthwhile if it is populated.
Response: The department agrees with the commenter on the importance of grandfathering data. No
change was made as a result of this comment.
Comment: Regarding §100.7(a), two commenters object to providers being required to permit the
inspection of immunization records for quality assurance purposes by the department. One commenter
suggests that this may be illegal.
Response: The department disagrees. Chapter 900, §2, Acts of the 75th Legislature, states:
"The Texas Department of Health shall evaluate the immunization registry, established under
Section 161.007, Health and Safety Code, as added by this Act, two years after its implementation
date to determine if the immunization registry is meeting its stated goals and objectives. The Texas
Department of Health shall report to the legislature on February 1 of each odd-numbered year
concerning the maintenance and operation of the registry." In order to evaluate the quality of
the data, the department must be able to inspect immunization records. For clarification the rules
were modified in §100.7(a) to read "records of children whose names appear in the
registry" will be inspected.
Comment: Concerning section §100.8(a), one commenter is concerned that 25 business days is not
adequate time to provide the immunization information from the health plan unless a consent is
received with each immunization.
Response: The department disagrees. It is the responsibility of the provider and the health plan
to communicate that consent to participate in the registry has been obtained. Health plans do not
have to research consent status. Health plans are only responsible for forwarding records to the
department when they are assured that consent has been given. No change was made as a result of this
comment.
Comment: Concerning §100.8(a), one commenter proposed changing 25 business days to 60 business
days, giving health plans more time to comply.
Response: The department disagrees. Immunizations are recommended at two month intervals during
the first 6 months of life. If the health plan waited the full 60 days for reporting, the child
would be due for the next series before the first series was received and entered into the registry.
The provider needs this to appropriately assess current immunization status. No change was made as a
result of this comment.
Comment: Concerning §100.8(a), one commenter asks if the health plan is obligated to confirm
consent on each submission to the registry. If so, the statement should be expanded to require a
consent modifier on each claim submitted.
Response: The department disagrees and responds that the health plan is under no obligation to
confirm consent on each submission. The providers must communicate changes in consent status to the
health plans. No change was made as a result of this comment.
Comment: Concerning §100.8(b), twenty-seven comments were received with objections to the use of
the Health Level 7 (HL7) data format.
Response: The department disagrees. Health Level 7 (HL7) is a "data standard". It is a
common language used for the transfer of data electronically. Completed parts of the HL7 format are
being used by other states and countries. The only sharing of data, would be at the request of the
parent, to transfer their child's immunization information from our system to another. HL7 will
provide a standard format for reporting. No change was made as a result of this comment.
Comment: Concerning §100.9(a), twenty-five comments were received with concerns that no limits
are written into the rule for recall and reminder systems.
Response: The department disagrees that limits should be defined by rule. However, currently the
immunization registry only has the capacity to recall a child three times. No change was made as a
result of this comment.
Comment: Regarding §100.9(b), twenty-seven comments were received stating objections to the
department omitting schools and day cares facilities from confidentiality requirements.
Response: The department agrees. The language was rewritten to state that any user of the
immunization registry will maintain the confidentiality of all immunization reports. A certain
amount of sharing of information may be required by Education Code §38.002(b). No change was made
as a result of this comment.
Comment: Concerning section §100.11, one commenter asked if the health plans have access to this
information.
Response: The department responds that the Health and Safety Code, §161.008(c)(2), states the
information can be released to a public health , a local health department, a physician to the
child, or a school or child care facility in which the child is enrolled. This does not include
health plans. Release to health plans has been removed from this section of the proposed rules. No
change was made as a result of this comment.
Comment: Concerning rules in general, one commenter recommends that our rules include a provision
that allows the release of immunization data from the registry for research purposes.
Response: The department responds that the law defines who can have access to the immunization
data, and there is no provision for research use. No change was made as a result of this comment.
Comment: Concerning rules in general, twenty-seven comments were received stating objection to
the lack of penalties for misuse of the registry.
Response: The department responds that penalties are outlined in the Health and Safety Code
161.009.No change was made as a result of this comment.
Comment: Concerning rules in general, twenty-eight comments were received with objections to the
lack of protection against those who choose not to participate.
Response: The department disagrees and responds it is not the practice of immunization providers
to pressure parents into entering their children's information into the registry. No change was made
as a result of this comment.
The commenters were Belinda Martel, Stacy Shelton, Julie A. Durham, Karen Walters, Debbie Otwell,
Mrs. Linda Lowder, Charles Erwin, Trace Carpenter, Mrs. Stacey Burks, Terri Erwin, Kelli Beaty,
Angie Wilson, William M. Chop, Jr., M.D., State Senator Jerry Patterson, David L. Tyson, Jon Van
Slaars, Angela Nash, Christine Orbin, L.L. Davidson, U.S. Senator Phil Gramm, Randy V. Curtis, M.D.,
Tina K.King, J. Wilson, Bryan Malatesta, Ms. Joy Rex, Douglas Moore, Nick Curry, M.D., M.P.H.; Texas
Medical Association, Tim Nash, Stephanie Marchbanks, Alison Mullins, Francisco Casales, Marcia Cook,
Gary Fritzsche; Blue Cross and Blue Shield of Texas, Inc., Roger L. and Sara Moncus, Christine
Casales, Candyce B. Hall, Randi Smerud, Larry L. Coffman, Doris M. Brown, Dawn Richardson, Paul
Ochoa, Susan Failes, Kathi Seay, Conservative Coalition, Janice Borne, State Representative Jerry
Madden, Camellia May, Laurie Smith, T.C. Wascher, M.D., Rebecca Rex, Patricia Zuercher, North
Central Texas HEDIS Coalition, Virginia Moore, M.D., Jill Hunt, Jeannine Kline, Mr. & Mrs. R.
David Oltrogge, Robert W. Bueker, C.P.A., State Represetative Bob Hunter, Jana Kappel, Denise M.
Burgos, M.D. Most commenters were opposed to the proposed rules. Some expressed concerns, asked
questions and made suggested recommendations for changes as discussed in the summary of comments.
The effective date of the rules is January 1, 1999.
The new sections are adopted under the Health and Safety Code, §§161.007-161.009 requiring the
department to establish an immunization registry and by rule develop guidelines; and §12.001, which
provides the Texas Board of Health with the authority to adopt rules for the performance of every
duty imposed on the board, the department, and the Commissioner of Health.
§100.1. Definitions.
The following words and terms, when used in this chapter, shall have the following meanings,
unless the context clearly indicates otherwise.
(1)
Child-The person or individual under 18 years of age, to whom a vaccine has been administered.
(2)
Consent-A statement signed by a parent agreeing that the child's immunization history can be
included in the registry, and that the child's immunization record may be released from the
registry. Consent must be obtained one time only and is valid until the child attains 18 years of
age. Parents may choose to withdraw consent at any time.
(3)
Department-The Texas Department of Health.
(4)
Health Plan-An insurance company, a health maintenance organization, or another organization that
pays or reimburses a provider for immunizations administered.
(5)
Immunization history-An accounting of all vaccines that a child has received and other
identifying information.
(6)
Immunization record- That part of the immunization registry that is released. An immunization
record contains the name and date of birth of the person immunized; dates of immunization; types of
immunization administered; and name and address of the provider administering the immunization.
(7)
Immunization registry-The database or single repository that contains immunization histories
which include necessary personal data for identification. This database is confidential, and access
to content is limited to authorized users.
(8)
Parent-The parent, managing conservator, or guardian from whom consent is obtained.
(9)
Provider-Any physician, health care professional, or facility personnel duly licensed or
authorized to administer vaccines.
(10)
User-An entity or individual authorized by the department to access immunization registry data.
(11)
Vaccine-Includes toxoids and other immunologic agents which are administered to children to
elicit an immune response and thus protect against an infectious disease.
§100.2. Inclusion of Information and Confidentiality.
(a)
The immunization registry shall contain information on the immunization history that is obtained
by the department under this section of each person who is younger than 18 years of age and for whom
written consent has been obtained in accordance with this section. The department shall remove
information from the registry for any person for whom consent has been withdrawn under §100.4 of
this title (relating to Withdrawal of Consent). The provider shall obtain the written consent from
the parent of a child before any immunization history relating to the child is sent to a health plan
or the department to be included in the registry. The consent language should be substantially
similar to the text of paragraphs (1), (2) and (3) of this subsection. The department shall prepare
appropriate forms to obtain consent and make sure they are available to providers.
(1)
"I authorize the placement of my child's immunization history into the Texas Department of
Health's Immunization Registry.
(2)
"I authorize the Texas Department of Health's Immunization Registry to release past,
present, and future immunization records on my child to a parent of the child and any of the
following:
(A)
public health district;
(B)
local health department;
(C)
physician to the child;
(D)
school in which the child is enrolled; and
(E)
child care facility in which the child is enrolled.
(3)
"I understand that I may withdraw the consent to place my child's immunization history in
the immunization registry and my consent to release my child's immunization record from the
immunization registry at any time by written communication to the Texas Department of Health,
Immunization Registry, 1100 West 49th Street, Austin, Texas, 78756."
(4)
A parent of a child who agrees to the submission of their child's immunization history to the
immunization registry should sign a signature block indicating their written consent to participate.
(5)
A consent statement must be signed for participation in the immunization registry. No information
should be forwarded to the department if consent is denied or if the status of consent is unknown.
(b)
At birth, parents will be able to consent for the child's future immunization history to be
included in the immunization registry by indicating approval on the birth certificate. This written
consent will be valid until age 18 unless the parent notifies the department that consent is
withdrawn.
(c)
As required by Health and Safety Code, §161.007, all information which identifies individuals
shall be protected as medical information in accordance with the Medical Practice Act, Texas Civil
Statutes, Article 4495b, §5.08.
(d)
As provided in Health and Safety Code, §161.007(e), the department may use the registry to
provide notices by mail, telephone, personal contact, or other means to a parent regarding his or
her child who is due or overdue for a particular type of immunization according to the department's
immunization schedule. The department shall consult with providers to determine the most efficient
and cost-effective manner of using the immunization registry to provide these notices.
(e)
A provider or health plan which provides information to the immunization registry in good faith
pursuant to this section is not subject to civil liability, as described in Health and Safety Code,
§161.007(g).
§100.3. Providers and Health Plans.
(a)
After December 31, 1998, a provider that administers a vaccine to a person younger than 18 years
of age and does not submit a claim for reimbursement to a health plan shall provide an immunization
history to the department if consent has been obtained.
(b)
A health plan that pays or reimburses a claim for an immunization of a person younger than 18
years of age shall provide the immunizations from only the current claim to the department, if
consent has been obtained. A health plan that pays or reimburses a claim may forward consented
immunization history to the registry.
(c)
A provider shall inform a parent of the child about the immunization registry in writing, and
provide them with an opportunity to consent to the inclusion of their child's information in the
immunization registry.
(d)
External computer systems supplying the immunization registry with immunization history will
incorporate an indicator field that records whether written consent for inclusion has been obtained.
(e)
If consent for participation in the immunization registry is obtained, the written consent for
inclusion shall be maintained with the provider.
§100.4. Withdrawal of Consent.
(a)
Upon receipt of a request to withdraw consent, the child's entire history shall be removed from
the immunization registry. A written confirmation shall be provided to the parent of removal from
the immunization registry within 30 business days of receipt by the immunization registry.
(b)
Providers shall forward a child's immunization history to the department or health plan for
inclusion in the immunization registry only when the parent has signed a written consent for the
immunization history to be included in the immunization registry. The department shall not keep a
child's immunization history in the immunization registry or other files when the parent has
requested in writing that the immunization history be deleted from the immunization registry.
(c)
The department shall prepare appropriate forms to withdraw consent to participate in the
immunization registry, and shall make them available to providers. A completed form is not required
to refuse to participate in the immunization registry. A parent who consents and wishes to withdraw
the consent at a later date, may send a signed request, in lieu of the form prepared by the
department. The written request must be mailed to the Texas Department of Health, Immunization
Registry, 1100 West 49th Street, Austin, Texas 78756 and contain the following information:
(1)
child's name;
(2)
child's date of birth;
(3)
child's gender;
(4)
name of parent;
(5)
an address where the parent can receive a confirmation notice;
(6)
signature of parent; and
(7)
date of signature.
§100.5. Reportable Information.
(a)
Information on vaccines administered shall be sent in a manner consistent with these rules and
procedures issued by the department. All immunizations for which there is consent shall be reported
to the immunization registry until the child's 18th birthday. The immunization history will be
purged or removed automatically from the immunization registry and archived on the child's 18th
birthday.
(b)
After consent is obtained, a provider reporting directly to the immunization registry, shall
submit all the immunization history required. Required immunization history consists of the
information listed in subsections (g)(2) and (3) of this section.
(c)
A child's immunization history shall be accepted without a social security number. However,
social security numbers are very important to assure that the immunization histories are complete
and adequately match. If available, the social security numbers shall be forwarded to the
department. Other information specified on forms and data file layouts as optional should be
provided, with the consent of a parent, when available.
(d)
Providers receiving notifications from parents requesting that their child's immunization history
not be reported to the immunization registry shall maintain documentation of the notice at the
provider's office and no information shall be forwarded to the department. A health care provider
who administers an immunization to a person younger than 18 years of age shall provide an
immunization history to the department unless the immunization history is submitted to a health plan
that pays or reimburses a claim for an immunization to a person younger than 18 years of age. If
consent for participation in the immunization registry is obtained, the immunization history shall
be forwarded to the department by the health plan.
(e)
Beginning on January 1, 1999, immunization histories shall be reported to the department by paper
forms, electronic transfer, fax, mail, telephone, or direct data entry into the immunization
registry within 30 business days of administering a vaccine in a format prescribed or approved by
the department. Providers and health plans may contact the department (1100 West 49th Street,
Austin, Texas 78756, 1-800-252-9152) to establish a provider number and a system of reporting.
Reporting by telephone is limited to providers that administer vaccine to less than 25 children per
month.
(f)
Reports submitted by electronic transfer shall meet data quality, format, security, and
timeliness standards prescribed by the department.
(g)
Beginning on January 1, 1999, with written consent from a parent, providers and health plans
shall report the following necessary information to identify a child, adequately track the child's
immunization status, allow for effective recall and reminder systems and satisfy the required data
elements in the immunization registry.
(1)
Provider information must include:
(A)
the health care provider's name (first, middle initial, last);
(B)
business address (street, city, zip code); and
(C)
business telephone number (including area code).
(2)
Child and parent information must include:
(A)
child's name (first, middle initial, last);
(B)
child's address;
(C)
child's social security number (if available);
(D)
gender of the child;
(E)
child's date of birth; and
(F)
mother's maiden name (if available).
(3)
Vaccine information must include:
(A)
type of vaccine administered;
(B)
date the vaccine was administered (month, day, year);
(C)
vaccine lot number (if known);
(D)
dose or series number (if known); and
(E)
name of vaccine manufacturer (if known). If the immunization history is entered as historical
data, the lot number and manufacturer are not required. Historical data are immunizations that were
administered prior to the present date and/or administered by a different provider.
(h)
Evidence of immunity to vaccine preventable disease shall be reported.
(i)
In addition to data required, optional information which aids in the tracking of children in the
immunization registry may be supplied at the discretion of the parent.
(j)
If written consent is obtained from a parent, providers should enter all immunization history.
(k)
Beginning January 1, 1999, with written consent, a provider shall submit immunization history to
the immunization registry. The provider is not required to submit immunization information to the
department when the immunization information is submitted to a health plan. Providers shall submit
evidence of consent when they submit the documentation of services provided to the health plan.
§100.6. Information Included in the Immunization Registry Prior to September 1, 1997.
(a)
Immunization histories contained in the immunization registry prior to September 1, 1997 that
were obtained from the following sources will remain in the immunization registry and may be
released from the immunization registry:
(1)
Integrated Client Encounter System (ICES);
(2)
Women, Infants and Children (WIC);
(3)
Medicaid; and
(4)
Texas Health Steps (formerly known as Early and Periodic Screening Diagnosis and Treatment -
EPSDT).
(b)
The department will develop informational materials for distribution and posting at all
provider's offices who have access to the immunization registry and in the provider offices using
the Integrated Client Encounter System (ICES), Women, Infants and Children (WIC), Medicaid, Texas
Health Steps (formerly known as Early and Periodic Screening Diagnosis and Treatment - EPSDT) that
will notify parents about the following.
(1)
Their child may already have an immunization history in the immunization registry from the one or
more of the sources listed in subsection (a) of this section.
(2)
The parent may request that the department search the immunization registry for the possibility
of an existing immunization history. They may call the department's toll free number, (800)
252-9152, or make the request in writing.
(3)
The parent may request that any existing immunization history be withdrawn and deleted from the
immunization registry as specified in §100.4 of this title (relating to Withdrawal of Consent).
§100.7. Data Quality Assurance.
(a)
As needed and for the purpose of assuring the quality and accuracy of the consented data
submitted to the immunization registry, each provider will allow the department to inspect the
immunization history of children whose names appear in the registry stored with the provider.
(b)
For immunization history with written consent, a provider shall, upon request of the department,
supply missing immunization history, if known, or clarify immunization history submitted to the
department.
§100.8. Health Plans Shall Provide Immunization History to the Department.
(a)
Health plans to which providers submit a claim or encounter information for an immunization,
shall in turn submit the required immunization history to the department within 25 business days
from receipt from the provider. The organization must be able to verify the presence of the consent
for participation in the immunization registry before the history is forwarded to the department.
(b)
Automated data exchange shall conform to standards prescribed by the department. Data exchange
shall follow the national standard for data exchange, known as Health Level 7 (HL7), when this
format is completed.
§100.9. Reports.
(a)
Authorized and registered providers or health plans may request recall and reminder reports from
the immunization registry to provide notices of an upcoming or overdue immunization.
(b)
Any user of the immunization registry shall maintain the confidentiality of all immunization
reports.
§100.11. Confidentiality.
(a)
Information contained in the immunization registry is confidential. Registered providers using
the immunization registry shall be required to sign a confidentiality disclaimer statement.
(b)
The department shall register providers and assign security levels.
(c)
Registered providers shall be assigned a user identification number and password. The registered
provider will be encouraged to periodically change the assigned password. The password will be
displayed on the screen as asterisks.
Filed with the Office of the Secretary of State on November 24, 1998.
TRD-9817962
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: January 1, 1999
Proposal publication date: August 7, 1998
For further information, please call: (512) 458-7236
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