PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 100. IMMUNIZATION REGISTRY
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§100.1 - 100.6, the repeal of §100.7 and §100.8, and new §§100.7 - 100.10, concerning the Texas Immunization Registry (the Registry). The amendments to §100.4 and §100.5, and new §100.7, §100.8, and §100.10 are adopted with changes to the proposed text as published in the March 21, 2008, issue of the Texas Register (33 TexReg 2478). The repeal of §100.7 and §100.8, amendments to §§100.1 - 100.3 and 100.6, and new §100.9 are adopted without changes and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The amendments, repeal, and new sections are necessary to implement portions of Senate Bill (SB) 11, 80th Legislature, Regular Session (2007), which amended Health and Safety Code (the Code), Chapter 161. New sections and amendments implement SB 11 requirements regarding the following scenarios: potential and declared disasters; public health emergencies; terrorist attacks; hostile military or paramilitary actions; and/or extraordinary law enforcement emergency events. SB 11 mandates a major expansion in the existing scope of the Registry. Under that legislation, the Registry must contain specified information regarding persons who receive an immunization, antiviral, and/or other medication administered to prepare for, and/or in response to, the listed scenarios. SB 11 also expanded the scope of the Registry by allowing first responders (and their immediate family members, as defined, over 18 years of age) to request that a provider who administers an immunization to that person provide information regarding the immunization to the department for inclusion in the Registry. This rulemaking also makes various clarifying amendments designed to improve the efficiency and readability of these rules sections. Also, the amendments, repeal, and new sections update the department, division, section, and branch names, and reorders text and sections to improve rule clarity.
The only change to the rules from proposal to adoption is the addition of a P.O. Box address for the department in rule language where the department's address is given.
Government Code, §2001.039, requires that each state agency review and consider for readoption every 4 years each rule adopted by that agency pursuant to the Government Code, Chapter 2001. Sections 100.1 - 100.8 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed to carry out the department's responsibilities under statute. Renumbering and revisions resulted in new §100.9 and §100.10.
SECTION-BY-SECTION SUMMARY
Section 100.1(2) is adopted to clarify that a managing conservator or legal guardian can also grant the requisite consent. Section 100.1(3) is adopted to reflect the language of the Code, §161.0001(1), including amendments made by SB 11. Section 100.1(4) is adopted to reflect the current name of the department. Former §100.1(5) is adopted and renumbered as §100.1(9), changing "child" to "person" to reflect SB 11 requirements. Former §100.1(6) and (7) are adopted and renumbered as §100.1(10) and (11), respectively. Former §100.1(8) is deleted as confusing and unnecessary language, and replaced with a new definition for "immediate family member" to reflect the requirements of SB 11. Former paragraphs (9), (10), and (11) in §100.1 are adopted and renumbered to §100.1(12), (14), and (17), respectively. Former §100.1(12) is adopted and renumbered to §100.1(18), with "a person" replacing "children" in order to reflect SB 11 requirements. New definitions are adopted and numbered as paragraphs (5) - (8), (13), (15), and (16) to implement SB 11 requirements.
Section 100.2(a) is adopted to reflect amendments made to the Code, §161.0073(a) by SB 11, and adds language to reflect that a managing conservator or legal guardian may also offer the required consent. Section 100.2(b) is adopted to add a statement which expressly states that Registry information may only be accessed by the persons listed in rule, for the purposes enumerated in the rule. Further amendments are adopted to reflect the new classes of persons brought into the regulatory scheme by SB 11. Amendments are also adopted at subsection (b) to reflect that a managing conservator or legal guardian may also offer the required consent.
Section 100.3 is adopted to change the section title to reflect that "guardian" is a reference to a "legal guardian." Section 100.3(a) is adopted to add managing conservators and legal guardians to the list of those to be informed under the requirement, along with a cross-reference to the method to be used. The subsection is also adopted to add language that reflects changes to §161.007(a) of the Code made by SB 11. Section 100.3(b) is adopted to add managing conservators and legal guardians to the list of persons who will receive the referenced materials. Section 100.3(c) is adopted to add managing conservators and legal guardians to the list of persons who may receive the referenced notices. Section 100.3(d) is adopted to add managing conservators and legal guardians to the list of persons that will receive the referenced notices. Section 100.3(d)(6) is adopted to add managing conservators and legal guardians to the list of persons regarding reporting the referenced violation, and to insert "alleged" in front of "violation" to reflect that such a violation will not have been proven at that point in the process.
Section 100.4 is adopted to change the section title, and subsection (a), to reflect that this rule section is only applicable to Registry consent and withdrawal relating to minors, since these same issues are dealt with separately in new §100.7 and §100.8 regarding SB 11 requirements as to certain adults. Section 100.4(a)(2) is adopted to update the current name and contact information of the department. Former subsection (b) is adopted and renumbered as subsection (c), with a new subsection (b) adopted which describes the consent process by which information on minors is included in the Registry. In the new subsection (b), the cross-reference to new §100.7 is necessary because SB 11 provides for inclusion of information regarding minors into the Registry without consent (and therefore without consent needing to be verified) in the limited situations described in that new rule section. New subsection (b) specifies how the department will handle consent verifications in situations involving minors where such verification is required, which is authorized under the authority given to the department under changes to the Code, §161.007(a)(5) made by SB 11. This process is designed to maximize efficiency of Registry operations. Former subsection (c) is adopted as new subsection (d), and is adopted to add managing conservators and legal guardians to the list of persons regarding withdrawal of consent, and is also adopted to add a cross-reference to new §100.7 to reflect the exception to the ability to withdraw consent, per SB 11. Former subsection (d) is adopted and renumbered as new subsection (e) to add managing conservators and legal guardians to the list of persons who may request exclusion of the information, while paragraph (2) updates the department's current name and contact information and also includes a cross-reference to new §100.7 to reflect the exception to the ability to request exclusion, per SB 11.
Section 100.5 is adopted to renumber former subsection (a) as new subsection (b), with changes that: reflect the new classes of persons brought into the Registry via SB 11; clarify that managing conservators and legal guardians are included in the list of persons who can submit the referenced information; improve readability; and expressly state that submissions of the referenced information must be according to department requirements. New subsection (a) is adopted to provide a comprehensive list of the classes of persons who will have information contained in the Registry, given SB 11 requirements. Former subsection (b) is adopted as new subsection (c), with changes that reflect the new classes of persons brought into the Registry via SB 11, as well as changes to improve readability. Former subsection (c) is adopted as new subsection (e), with changes that: effectively reflect the statutory scheme for release of immunization records; expressly states the limitations of use (if any) for each class of person listed, to prohibit parties allowed direct access to the Registry from viewing records beyond those they are authorized to see, given state and federal confidentiality laws; and expresses the limitation of direct electronic access to the Registry, which is necessary due to resource constraints of the department and is advisable to help preserve confidentiality. Former subsection (d) is adopted as subsection (h), with changes that better express liability limitations by cross-referencing the applicable Code provision, rather than attempting to paraphrase statutory language. A new subsection (d) is adopted to concisely set out the methods the department has to choose from when verifying consent, under the authority granted the department under §161.007(a)(5) of the Code as amended by SB 11. Former subsection (e) is adopted as new subsection (i), with changes to reflect the new classes of persons brought into the Registry via SB 11. New subsection (f) is adopted to provide a cross-reference to new §100.7 regarding release of information under the scenarios described in that rule. New subsection (g) is adopted to provide a cross-reference to new §100.8 relating to release of information regarding first responders and their immediate family under that rule.
Section 100.6 is adopted to add language to the section title which states that the section covers medical verifications as well, and that the entire section is applicable only to minors (as opposed to adults added to the Registry scheme under SB 11, which are covered elsewhere in the rules). Amended subsection (a) is adopted with improvements to readability and clarity. Amended subsection (b) is adopted to delete confusing and outdated text and replace it with a clear statement regarding the providers' obligation to submit the required data elements to the department within the stated 30-day deadline. Amended subsection (c) is adopted in an approach similar to subsection (b), except that (c) applies to applicable payors as opposed to providers. Amended subsection (d) is adopted to add managing conservator and legal guardian to the list of persons who can provide a child's immunization history to the department. Former subsection (e) is deleted because its subject matter is covered under other provisions under this section as reorganized. Former subsection (f) is adopted as subsection (e), with changes to improve clarity. Former subsection (g) is adopted as subsection (f).
The text in existing §100.7 and §100.8 is adopted as §100.9 and §100.10, respectively, with changes as part of the reorganization of this chapter (see discussion as follows).
New §100.7 is adopted to implement changes to the Code, Chapter 161, amended by SB 11 regarding the following scenarios: potential and declared disasters; public health emergencies; terrorist attacks; hostile military or paramilitary actions; and/or extraordinary law enforcement emergency events. Senate Bill 11 mandates a major expansion in the existing scope of the Registry. Under that legislation, the Registry must contain specified information regarding persons who receive an immunization, antiviral, and/or other medication administered to prepare for, and/or in response to, the listed scenarios--as stated in adopted new subsection (a) in this section. The provider deadline to submit data elements is set at 30 days in the new subsection (b). This will allow the Registry to reflect an accurate picture of the immunizations, etc. being administered in the emergency so that information will be available to those who need it. Senate Bill 11 amends §161.00705 of the Code to include requirements for the department to track adverse reactions in these situations, and adopted new rule subsection (c) implements this requirement. The rule language states that such tracking will be based on reports the department receives from health care providers, as opposed to being based on an impractical attempt by the department to proactively contact all providers who were active in any given disaster/emergency. The statute does not make such reporting mandatory for providers, and the department does not have the resources to attempt to identify and contact all these providers who administered health care during the emergency. Senate Bill 11 provides that consent is not necessary for the health care information at issue to be included in the Registry, but goes on to charge the department with determining the time period following the disaster/emergency event after which consent would be required for continued inclusion. Department Preparedness Program staff have analyzed this situation, using their long expertise in public health and emergency management in Texas, and have determined that the appropriate time period is five years after the end date of the emergency scenario. Reasons for choosing this time period are based on public health needs:
(1) The 5-year period is commonly used as the interval for when boosters are recommended (e.g., tetanus, pneumonia if >64 years). To avoid over-immunizing individuals under adopted §100.7, and to avoid the costs of revaccinating persons who don't keep personal records, a five-year period in the Registry would be sufficient for record-checking purposes.
(2) Adequate time is needed to track individuals with adverse reactions that are reported to the department by the providers at issue. It is currently unknown how many adverse reactions will result from use of antiviral drugs, antibiotics, vaccines, or emergency use authorization (EUA) drugs that may be used during a scenario described in adopted §100.7. The department tracking of adverse reactions following such a scenario may take years, especially if a large number of individuals are affected. Five years is a minimal time in which to examine trends.
New §100.7(d) specifies the details of how this post-emergency transition period will work. Since the Texas Legislature did not define the various emergency terms used in SB 11, and did not include an explicit method for determining their duration, the adopted new subsection (d) states that: for types of emergencies where existing statutes provide for the duration, that will be the controlling trigger dates; for types of emergencies where the law does not so provide, the department will determine the end date and post it on the department website. The department will use its expertise in public health and emergency management to make the latter determinations, and the website posting should be an effective method of getting this information disseminated. Once the time period referenced in subsection (d) has passed, consent is required under SB 11 and adopted new subsection (e) details the mechanics of that process. Adopted new subsection (f) pertains to department release of the information, and implements SB 11 changes to the Code, §161.00705(g).
New §100.8 implements changes to the Code, Chapter 161, amended by SB 11 regarding immunization information of first responders and their immediate families. SB 11 contains a second major expansion in the existing scope of the Registry. Under that legislation, first responders (and immediate family members, as defined, over 18 years of age) may request that a provider who administers an immunization to the person provide information regarding that immunization to the department for inclusion in the Registry, as described in adopted new rule subsection (a). Unlike the scenarios described in adopted new §100.7, SB 11 does not make this requirement mandatory. Rather, it is an available option for the persons covered. Adopted new subsection (b) requires the provider to submit that information, upon receiving such a request, as mandated by SB 11 through amendments to §161.00706(b) of the Code. The language in this rule subsection goes on to articulate deadlines and mechanics for how this works, including the logistics and methodologies for verification of the request for inclusion in the Registry. Adopted new subsection (c) describes the logistics of making the request. Adopted subsection (d) covers the issue of medical verification regarding information submitted under this section, and lists documents that will be acceptable for that purpose. Adopted new subsection (e) details when the department can release such information, and this language tracks SB 11 amendments to §161.00706(d) of the Code. Adopted new subsection (f) details the ability of persons to have their information removed from the Registry, and this language tracks SB 11 amendments to §161.00706(e) of the Code.
New §100.9 provides the definition for an official immunization record, and is merely the language from existing §100.7 moved as part of the reorganization of this chapter.
New §100.10 provides instructions for filing complaints about the Registry, and details the department's associated reporting requirements. This is the language from existing §100.8 moved as part of the reorganization of this chapter, but with changes that: insert "alleged" in front of "failure to comply" to reflect that such a violation will not have been proven at that point in the process; improve readability; and include new reporting requirements associated with SB 11.
COMMENTS
The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenters were two individuals and the following associations: Texas Children's Hospital, Houston Area Immunization Partnership, and the Texas Pediatric Society. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments.
Preliminary Comments
The department communicated with stakeholders during the rules development process and provided proposed rules to stakeholders in advance of the 30-day public comment period. The department requested preliminary comments from stakeholders. The department received written comments from stakeholders in response to the request for preliminary comments. All but one of the comments received during the preliminary comment period were also submitted or raised by other commenters during the formal (30-day) comment period. Comments and the department responses are summarized as follows.
Preliminary Comment: Concerning §100.3(a), one commenter suggested that "childhood" be removed, as most vaccine protection extends throughout the lifespan and adolescent vaccines are becoming more prominent.
Response: Although the department is not required by the Administrative Procedure Act (APA) to respond to this preliminary comment, the department offers the following reply: the department disagrees with this preliminary comment because the term "childhood" reflects the primary purpose of the registry as stated in Code, §161.007 and §100.3 specifically only covers persons under 18 years of age. No change was made to the rule as a result of this comment.
Formal Comments (30-day comment period)
Comment: Concerning new §100.5(b), several commenters expressed concern that the language will restrict reporting by some entities, listing as examples local immunization registries, health information exchanges, daycare providers, insurance companies, and elementary, middle and high schools. Some commenters suggested that "any verifiable source" be able to submit data and that the burden should be on the department to accept data from as many sources and in as many formats as possible. Some commenters objected to the requirement for data submission "according to the procedures and format prescribed by the department," saying such language could limit what entities can submit data to the Registry and also saying that such language would put the responsibility on those parties submitting data electronically into the Registry to interface with the computer system the department uses. One commenter said that if that phrase was meant to refer to "technical procedures" or "administrative requirements," then "it may be a reasonable requirement."
Response: Long-standing language in the Code, §161.008(c), which was unchanged by SB 11, limits what types of entities and individuals can submit data to the Registry. The new language for §100.5(b), and indeed all the language in this rule chapter, reflects this statutory limitation. The department does not have the authority to expand acceptable data sources by rule. Local immunization registries, health information exchanges, day cares, and schools are not listed in the statutory provision. Insurance companies are, however, under the term "payor." The only place in the Code, Chapter 161, that mentions local immunization registries or "regional health information exchanges" at all is at §161.007(a)(5), which was added by SB 11 and which only has the effect of including these entities (which are not defined) in the consent verification process. This language has no bearing whatsoever on the allowable entities from which the department can accept data in the first place, as limited by §161.008(c).
The Code requires that data elements be "submitted in a format prescribed by the department." The language added to the end of §100.5(b) is in recognition of the fact that numerous methods and procedures now exist for transmitting electronic data. However, some methods, though technologically feasible, may not be appropriate for secure transmission of confidential public health data. Also, the department has very limited information technology resources and is, therefore, constrained in what kind of electronic computer system it can implement. This new requirement in §100.5(b) is designed to allow the department to establish appropriate standards for secure data submission, to maximize Registry efficiency and control department costs. This new rule language does not prevent the department from expanding the acceptable formats for submitting data if additional funding becomes available. Based on stakeholder input, and working with providers and electronic medical records vendors, the department is researching technology to allow the submission of data in as numerous appropriate data formats as resources allow. No change was made to the rule as a result of these comments.
Comment: Concerning §100.5(c), commenters expressed concern that the new rule language would prohibit the department from retaining submitted data for a set period of months while consent is verified. Periods as long as 6 months were suggested to be put in the rule for retention of unconsented data to allow for verification of consent.
Response: The Code does not allow the department to retain Registry data for which consent cannot be verified (except under the emergency circumstances as described in new §100.7 where consent is not required). While there is an implied period of time in the statute where consent verification is sought, the department does not believe it has the authority to implement a specific retention period for unconsented data by rule. However, the improvements in this rulemaking to the consent verification process are intended to increase the efficiency (and thus the speed) of consent verification. Also, the department notes that old rule language at §100.6(e), was moved in substantially similar form to §100.4(b) as part of the overall chapter reorganization, calls for the provider to be notified when consent cannot be verified which should help clear up consent verification miscommunication or glitches. No change was made to the rule as a result of these comments.
Comment: Concerning §100.5(d)(1), some commenters suggested that the parent be allowed to grant consent by electronic signature directly on the birth certificate in order to facilitate the enrollment of newborns into the Registry, and argue that the Code requires this option. It is argued that the current newborn enrollment system as well as the system that is set up under the new rule would be less efficient that one that was in place at some point in the past where a parent checked a "consent" box on the birth certificate itself.
Response: The Code, §161.007(a-1) and §161.0071(e), were written to authorize a parent, managing conservator, or guardian of a child to provide written consent, or request exclusion, by using an electronic signature on the child's birth certificate. The Code, §161.007(c) and §161.007(d), require the department to verify consent prior to including information in the Registry, and prohibit the department from retaining information about a person for whom consent cannot be verified. It is the department's position that verification of consent must require that the parent be provided with sufficient information regarding the Registry to ensure that the parent understands what the Registry is and what they are agreeing to. This interpretation is consistent with the circumstances surrounding the passage of House Bill (HB) 1921 (78th Legislature, 2003), which amended the Code to require the department to implement new procedures for allowing a parent to request exclusion from the Registry during the birth registration process and for verifying consent prior to inclusion of client information in the Registry.
Prior to implementation of HB1921, which was implemented in January 2005, the parent's consent for a newborn's participation in ImmTrac was obtained by checking a box on the birth registration worksheet that hospital birth registrars commonly used to collect information for preparation of the birth certificate. The birth certificate was typically prepared and filed several days or weeks later. From a process perspective, obtaining the parent's signature "on" the birth certificate document was not feasible because the birth certificate was typically not prepared and filed until after the parent left the birthing facility.
The requirements of HB1921 relating to the requirement to provide the parent an option to either grant consent or request exclusion, and the requirement for verification of consent by the department, as well as the department's determination that verification of consent would require that the parent was sufficiently educated about the Registry so that consent could be considered to be informed, resulted in implementation of the process being replaced by the new rules. Also, the use of birth registration worksheets was being phased out as part of a move toward an electronic birth registration system. The department asserts that the new rules, which authorize the department to verify consent by accepting electronic affirmation by a birth registrar that consent has been obtained, will simplify and streamline the newborn consent process and facilitate the enrollment of newborns in the Registry at a higher level than previous processes. Under this new system, there will be no need for multiple visits with the parents and there will be no need for faxing forms or processing and storing electronic images in order to obtain and verify consent.
The department asserts that the new rules will result in a greater number of children participating in the Registry generally, while also fulfilling the necessity for the department to verify that informed consent has been obtained. No change was made to the rule as a result of this comment.
Comment: Concerning §100.5(d)(3), several commenters stated that the department does not have the authority under the Code to prescribe the "manner" in which parental consent is obtained, and suggested that the department allow parental consent by use of private physician electronic medical records software and local immunization registry consent forms.
Response: For years, the Code has required that the department verify that consent has been given for inclusion of the information in the Registry. Two elements the department sees as inherent in this legislatively-mandated duty are: (1) ensuring that the consent is for inclusion of the data in ImmTrac, as opposed to some other registry; and (2) taking steps to ensure that the consent was informed. Regarding the first point, consent for inclusion in a local registry, for example, is not the same as consent for ImmTrac inclusion. Even if a form used by some third party attempted to include language, which also covered ImmTrac consent, there would always be the matter of whether such language was legally sufficient to actually achieve that additional consent. Regarding the second point, it is the department's position that only informed consent equals "consent." If the person granting consent has not been given enough information to know what they are agreeing to, then it is not true consent and thus the department cannot verify that proper consent has been given. Legislative intent when consent verification legislation was passed would appear to be that the department was to begin verifying consent in order to provide consistency in the way consent is obtained, so that it would truly be informed consent. Private physician electronic medical sources and local registry consent forms may not contain information to address either of the two concerns outlined previously in this preamble. Senate Bill 11 specifically allows the department to determine the "process" by which consent is verified, including affirmation by the parties listed at the Code, §161.007(a)(5), and it did not relax the underlying consent verification itself that the department must conduct. No change was made to the rule as a result of this comment.
Comment: Concerning §100.5(e)(2), some commenters suggested the addition of language that would specifically allow for the release of ImmTrac data to immunization registries in other states.
Response: While the department may feel that such sharing of data is beneficial from a public health standpoint, the Code unfortunately does not allow for such a release of information. The department does not have the authority to address this issue by rule. The Code, §161.008(c) and (d), include "local health departments," and "public health districts," as entities that may submit information to, and view information from, ImmTrac. These two terms are established at the Code, §121.031 and §121.041, and are entities created under Texas statute. Under existing law, these definitions cannot be interpreted to include out-of-state counterparts. To the extent that any ImmTrac information would "relate to cases or suspected cases of diseases or health conditions," the release the commenters suggest would also be prohibited by the Code, §81.046. Amendments to the Code at all these sections would be necessary before the department may write the rule language as sought by the commenters.
Comment: Concerning §100.5(e)(2)(A), several commenters objected to language which limits use of Registry data by local health departments and public health districts for public health purposes "within their areas of jurisdiction." Commenters suggested that providers and local health departments should be authorized to view records for any client who seeks treatment in their facility, regardless of in which jurisdiction that child resides. Commenters also object to the rule language that would limit use of Registry data by providers to that of "treating the child as a patient," based on the supposition that such language would block data exchange between ImmTrac and local immunization registries and/or regional health information exchanges. One commenter suggested that the department should limit its revisions to those based on statutory language changes in SB 11.
Response: The phrase "within their areas of jurisdiction" in the new rule language refers to the public health purposes, not to the original residence or origin of the individual patient being treated by that local health entity. This limitation would not limit data exchange or restrict access for any public health purpose that occurs within a public health entity's jurisdiction. Therefore, in the situations mentioned by the commenters where people flee the scene of an emergency and receive health care from a local health department in a different part of the state, that health department would still be able to access the Registry data regardless of whether the child resides within the jurisdiction of that local health department. Because of confidentiality restrictions in federal and state law, the proposed language is intended to state what the department believes is a non-controversial, long-standing proposition--namely, that a public health district or local health department cannot see this confidential information unless it is for a legitimate public health purpose. For example, a local health department in the Panhandle region of North Texas could not legitimately look at the ImmTrac records for a child who lives in the Valley area of South Texas and who is not being treated by that Panhandle local health department.
The immunization records at issue here are confidential under a variety of state and federal statutes and regulations, and any exemption to that confidentiality requires specific statutory authority. Not all doctors may see the records of all persons who are being treated by a doctor, for example. In the case of ImmTrac, the Code, §161.008(c), the exemption is phrased as being applicable to "a physician to the child." The proposed rule merely reflects that statutory requirement. The fact that the statutory language in question was enacted prior to SB 11 is irrelevant...nothing in SB 11 changed that language or its effect, and the department is not limited in its rulemaking powers to only implementing new legislative amendments. In fact, the 4-year regulatory review required in Government Code, §2001.039, is designed to make agencies periodically review the appropriateness of their rules, which includes a fresh look at how the rules in question flow from the statutory authority for those rules. In this instance, the rule language is amended to better reflect a clear statutory limitation on the exception regarding provider access to confidential information. Additionally, as stated previously in the department's answer to comments regarding §100.5(b), long-standing language in the Code, §161.008(c) and (d), which was unchanged by SB 11, limits what types of entities and individuals can submit data to, and view information in, the Registry. Nothing in the statute gives local immunization registries or health information exchanges the ability to conduct "data exchanges" as referenced by the commenters. So any rule changes sought to create or facilitate this type of Registry access by these two types of entities are invalid on their face and will not be considered. No change was made to the rule as a result of this comment.
Comment: Concerning §100.5(e)(3), several commenters suggested striking this language because it could be interpreted to prevent electronic interfaces or other types of two-way exchanges with other state and local registries in the event of an emergency; and could also be interpreted to limit data sharing with local immunization registry systems or health information exchanges, thereby limiting the ability of local communities to populate their local database and increase the over-all number of immunization records captured. One commenter claims that the most recent consent system for "older children" under the rules was "very unmanageable" and that the department conducts "no outreach" into local communities to populate the Registry.
Response: The department disagrees because §100.5(e)(3) specifies that direct electronic access to the Registry shall be limited to the same entities, and under the same limitations of use, as specified in §100.5(e)(2), which relates only to the release of data constituting an immunization record. This is consistent with the Code, §161.008(c) and (d). The commenters say that the rule could be interpreted to prevent the development of electronic interfaces linking users directly to ImmTrac from local registries or health information exchanges. It is the statute, under which these rules are promulgated, that prevents the linkage referenced in the comment. The two types of entities the commenter references are not included in the statutory list of entities that may submit information to, and access information from, ImmTrac. Further, while the department does not agree with the commenter's characterization of the system under the previous version of the rules, the improvements to consent processes that will be implemented under these new rules will add efficiency and ease-of-use to the system. All entities allowed by law to interface with the system should benefit from these improvements. Out of state registries are not allowed under Texas law to interface with the Registry, as detailed in the department response to the comments regarding §100.5(e)(2). Further, the statutory limitations on Registry interface found in the Code, §161.008(c) and (d), are not trumped by any language in the Code, §161.010 and §161.0101. The outreach activities referenced in these statutory provisions are one that the department, in fact, conducts and these activities include collaboration with a wide variety of public and private, regional and local entities around the state. However, it is not a prerequisite of that outreach that entities the department works with in spreading awareness about the vaccines and the Registry have direct access to ImmTrac. The provisions of the Code, §161.008(c) and (d), control in this matter and there is no conflict within the statute on this question. The department notes that it has conducted outreach to increase ImmTrac registration for many years, and will continue to do so in an effort to maximize the number of individuals with records in the Registry and the number of health care providers and other allowed users participating in, and reporting immunizations to, the Registry. The department provides support and coordinates outreach activities with its regional offices and local health departments to educate parents about the Registry, encourage enrollment of children in the Registry, recruit providers and promote provider participation, and encourage providers to use Registry data in an effective way to promote public health. The department's education, promotion, and outreach activities, in coordination with the work of many stakeholders across the state, have contributed to significant growth in the Registry's total client participation, immunization records reported, and participation by providers and other allowed users.
The Code, §161.007(a), directs the department to establish and maintain an immunization registry for the primary purpose of "establishing and maintaining a single repository" of immunization records. The Code does not direct (or allow) the department to enter into data sharing relationships, with the entities referenced by the commenters, to populate local community databases. No change was made to the rule as a result of this comment.
Comment: Concerning §100.6(a), several commenters objected to language stating that electronic data submissions be in the "format and manner" prescribed by the department. Commenters stated that the burden should fall on the department to accept data from as many potential data sources and in as many data formats as possible from "any verifiable source."
Response: Please reference the department answers to comments on §100.5(b) regarding entities that can input data, and have access, to ImmTrac. No change was made to the rule as a result of this comment.
Comment: Concerning §100.6(e), several commenters objected to removal of the requirement that the department notify providers when consent cannot be verified; commenters requested that previous language not be deleted.
Response: As stated in the proposal preamble for this rulemaking, and during subsequent stakeholder discussions, the requirement that the department notify the provider if consent cannot be verified has not been eliminated. For more efficient organization of the chapter, the notification requirement has been removed from §100.6(e) and substantially similar language is now included in §100.4(b), which relates specifically to consent requirements. The department agrees that provider notification under this language is important. No change was made to the rule as a result of these comments.
Comment: Concerning §100.7(d), a commenter stated that 4 years is a significant time to collect data, however it is far too long a time to commit to a valid epidemiological record. This commenter suggested that an 18 to 24 month period is a more appropriate period to collect data relating to a disaster, and recommended that statistical analysis with consideration for disaster/population dynamics be applied to control, contain, and prevent possible disease migration. Another commenter recommended that the department extend the period of time for retention of unconsented disaster-related Registry information to a period longer than five years.
Response: The department did not fully understand the comment relating to a period of time to collect data. Section 100.7(d) pertains to the period of time that data collected during a disaster or emergency event will be retained in the Registry after the end of the event if consent is not obtained. The department disaster preparedness experts have determined that 5 years is the appropriate retention time period, for all the reasons listed in the Section-by-Section summary above regarding this rule section. It does not appear to the department that this commenter has provided any basis for re-evaluating that 5-year period.
The commenter that recommended an extended retention period did not put forward substantive information for the department to consider regarding why a longer time period would be appropriate. No change was made to the rule as a result of this comment.
Comment: Concerning §100.7(f), some commenters suggested the language be modified to clarify that providers would not need to re-consent patients in order to share immunization records with other providers and health departments in the event of a disaster.
Response: The language now §100.7(f) reflects the language in SB 11, which amended the Code, §161.00705(g). The proposed rule does not add an additional consent requirement--one proper consent is all that would be required. If consent is informed, as these proposed rules would ensure, then consent to have data included in ImmTrac includes consent to have that data viewed in ImmTrac by the persons listed in the statute/rules. Also, see department response to comments regarding §100.5(d)(3) previously. No change was made to the rule as a result of this comment.
Comment (general): Some commenters expressed concern that, through promulgation of the proposed rules, the department appears to be attempting to narrow the scope of with whom data may be properly exchanged going beyond the language and intent of the statute. Commenters object to any language in the rules, which has this effect, with specific concerns relating to data exchange with local registries and health information exchanges, as a misuse of the department's discretion pursuant to the APA set forth in Government Code, §2001.174(2). One commenter also urges the department to "consider future technological advancements and how Texas communities will use these tools over the coming decades to improve and enhance the public health and well-being of residents across this state."
Response: The department shares the desire of these commenters to maximize immunization data in the Registry as a way of improving the public health in Texas. However, long-standing language in The Code, §161.008(c), which was unchanged by SB 11, limits what types of entities and individuals can submit data to the Registry. New language in this rule chapter reflects this statutory limitation. The department does not have the authority to expand acceptable data sources by rule. Local immunization registries and health information exchanges are not listed in the statutory provision. The only place in the Code, Chapter 161, that mentions local immunization registries or "regional health information exchanges" at all is at §161.007(a)(5), which was added by SB 11 and which only has the effect of including these entities (which are not defined) in the consent verification process. This language has no bearing whatsoever on the allowable entities from which the department can accept data in the first place, as limited by §161.008(c).
The APA provision cited by commenter actually supports the department's position in this matter. While the cited provision concerns how the standard of review in a suit challenging an agency rulemaking is determined, it is instructive to note that the trigger for a court action adverse to an agency is when that agency adopts a rule that is at odds with the agency's statutory authority to promulgate that rule. As discussed immediately above, and throughout this preamble, it is precisely the limitations of the Health and Safety Code, which prohibit the department from writing a rule with the content the commenters seek. If the department were to allow, by rule, entities beyond those provided for at the Code, §161.008(c) and (d), to submit information to, and access information from, the Registry--that would constitute the improper department action, which the APA provision contemplates.
Regarding the general statement concerning "future technological advancements," the department responds that it does try to stay abreast of such developments and to incorporate those, which our very-limited electronic information systems resources allow. The department is working to maximize the efficiency and effectiveness of the ImmTrac system and associated processes within these very real limitations. No change was made to the rule as a result of these comments.
The only change to the rule text from proposal to adoption is the addition of a P.O. Box address each place that the department's physical address is located.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendments and new rules are adopted under Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004, which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and Chapter 161, concerning the Immunization Registry; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.
§100.4.Registry Consent and Withdrawal Relating to a Minor.
(a) A parent, managing conservator or legal guardian of a patient younger than 18 years of age may consent to the inclusion of the child's immunization history in the immunization registry by doing one of the following:
(1) indicating consent at birth certificate registration, including by electronic signature;
(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch at (800) 252-9152 to request a consent form;
(3) completing written consent to be submitted to a heath care provider, birth registrar, regional health information exchange, or local immunization registry, who may review that consent and affirm that consent has been obtained via an affirmation process as directed by the department.
(b) Unless otherwise provided by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event), the department shall verify consent before including the reported information regarding the child in the immunization registry. Under Health and Safety Code, §161.007(a)(5), the department may elect to verify consent by receiving affirmation from a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained. The department shall provide notice to a provider that submits data elements for a person for whom consent cannot be verified. The notice shall contain instructions for obtaining and affirming consent and resubmitting the data elements to the department.
(c) Consent is required to be obtained only one time, and is valid until the child becomes 18 years of age, unless the consent is withdrawn in writing.
(d) A parent, managing conservator or legal guardian of a patient younger than 18 years of age may withdraw consent for the child to be included in the registry at any time by submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch at (800) 252-9152 to request a consent withdrawal form. Unless otherwise provided by §100.7 of this title, the department shall remove information from the immunization registry for any person for whom consent has been withdrawn, and the department shall send the parent, managing conservator or legal guardian a written confirmation of the removal of the information. The department may not retain individually identifiable information about any person for whom consent has been withdrawn except as provided for by §100.7 of this title.
(e) A parent, managing conservator or legal guardian may request exclusion of a child's immunization history from the immunization registry by doing one of the following:
(1) indicating the request for exclusion at birth certificate registration, including by electronic signature; or
(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch at (800) 252-9152 to request an exclusion form. Unless otherwise provided by §100.7 of this title, on receipt of a written request to exclude a child's immunization records from the registry, the department shall send the parent, managing conservator or legal guardian a written confirmation of receipt of the request, and shall exclude the child's records from the registry. The department may not retain individually identifiable information about any person for whom an exclusion has been requested, unless otherwise allowed under §100.7 of this title.
§100.5.Receipt and Release of Registry Data.
(a) The immunization registry must contain information on the immunization history obtained by the department under this chapter regarding:
(1) a person who is younger than 18 years of age and for whom consent has been obtained;
(2) persons immunized to prepare for or in response to an event under §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event); and
(3) first responders and/or their immediate family members for whom a request has been submitted, as described at §100.8 of this title (relating to First Responder Immunization Information).
(b) The department may obtain the data constituting an immunization record for a person from a public health district, a local health department, the parent, managing conservator or legal guardian of a patient younger than 18 years of age, a physician, a payor, or from any health care provider licensed (or otherwise legally authorized) to administer vaccines. Submission of this information must be according to the procedures and in the format prescribed by the department.
(c) Except as provided by §100.7 and §100.8 of this title, the department shall verify consent before including information received under subsection (b) of this section in the immunization registry. The department may not retain individually identifiable information about a person for whom consent cannot be verified.
(d) When the department verifies consent under subsection (c) of this section, it may do so by any of the following, at its discretion:
(1) manual or electronic review of the consent form document signed (including by electronic signature) by a parent, managing conservator or legal guardian at birth certificate registration;
(2) manual or electronic review of a consent form signed by a parent, managing conservator or legal guardian and submitted to the department by mail to the Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756 (consent forms may also be received by facsimile);
(3) affirmation by a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained, as described in Health and Safety Code, §161.007(a)(5), and in a manner prescribed by the department.
(e) Except as limited by subsections (f) and (g) of this section, the department may release the data constituting an immunization record:
(1) to the parent, managing conservator, and/or legal guardian of a person younger than 18 years of age; and/or
(2) to the following entities, with those entities subject to the stated limitations:
(A) a Texas public health district or a Texas local health department, for public health purposes within their areas of jurisdiction;
(B) a physician or any health care provider licensed (or otherwise legally authorized) to administer vaccines in Texas, for treating the child as a patient;
(C) a Texas school or Texas child care facility, for a child enrolled in that school or child care facility;
(D) a payor currently authorized by the Texas Department of Insurance to operate in Texas, for immunization records related to the specific person in Texas covered under the payor's policy; and/or
(E) a state agency having legal custody of a child.
(3) Direct electronic access to the immunization registry information shall be limited to entities described in paragraph (2) of this subsection, for use under the stated limitations and subject to registration and access requirements as provided by the department.
(f) For persons immunized to prepare for, or in response to, an event covered by §100.7 of this title, the department may release information from the registry as provided in §100.7(f) of this title.
(g) For first responders and/or their immediate family members 18 years of age or older, the department may release information from the registry as provided in §100.8(e) of this title.
(h) Health and Safety Code, §161.0105, provides limited liability protections, as described in those provisions.
(i) The department may release nonidentifying summary statistics related to the registry that do not individually identify an individual.
§100.7.Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event.
(a) The immunization registry shall contain information regarding persons who receive an immunization, antiviral, and/or other medication administered:
(1) to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, and/or an extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title (relating to Definitions);
(2) in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action and/or extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title.
(b) A health care provider who administers an immunization, antiviral, and/or other medication as described in subsection (a) of this section shall provide the data elements to the department, within 30 days of that medical treatment, in a format and manner prescribed by the department.
(c) The department shall track, in the immunization registry, adverse reactions to an immunization, antiviral, and/or other medication administered as described in subsection (a) of this section. A health care provider who administers such an immunization, antiviral, and/or other medication may provide data related to adverse reactions to the department, in a format and manner prescribed by the department, for inclusion in the immunization registry. Department tracking will be based on the reports it receives under this subsection.
(d) Unless consent is obtained and verified, the individually identifiable information collected in the registry under this section shall only be retained in the registry for a period of 5 years following the end of the event as described in subsection (a) of this section. The end date of these occurrences shall be as specifically provided for by law. In the absence of law which specifically determines the end date, the department shall determine such an end date and post that date on its website.
(e) An individual or, if a child, the child's parent, managing conservator or legal guardian, may consent in writing to the continued inclusion of the person's information collected under this section in the registry past the retention time period specified in subsection (d) of this section by:
(1) mailing (or faxing) written notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a consent form may be obtained by calling the Immunization Branch at (800) 252-9152, or online at www.ImmTrac.com); or
(2) completing a consent form document, which must be verified by affirmation by a health care provider in a manner prescribed by the department.
(f) The department may release the information collected in the registry under this section with consent of the individual or, if a child, the child's parent, managing conservator or legal guardian, or to a state agency or health care provider for:
(1) the purposes outlined in Health and Safety Code, Chapter 161, Subsection A; and/or
(2) the purpose of aiding and coordinating communicable disease prevention and control efforts during an event as described in subsection (a) of this section.
§100.8.First Responder Immunization Information.
(a) A person 18 years of age or older who is a first responder or an immediate family member of a first responder may request that a health care provider who administers an immunization to the person provide the data elements regarding the immunization to the department for inclusion in the registry.
(b) A health care provider, on receipt of a request under subsection (a) of this section, shall submit the data elements to the department within 30 days of administration of the vaccine in a format and manner prescribed by the department. The department shall verify the request before including the information in the registry. The department may elect to verify the request for inclusion in the registry by obtaining an affirmation from the health care provider that a request has been received.
(c) A person 18 years of age or older who is a first responder or an immediate family member of a first responder may request inclusion of that person's immunization history in the registry by:
(1) mailing written notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a request form may be obtained by calling the Immunization Branch at (800) 252-9152, or online at www.ImmTrac.com); or
(2) completing a written request to the person's health care provider, to be verified by affirmation (in a manner prescribed by the department) by the health care provider that such a request has been received.
(d) The department shall ensure that the immunization history submitted by the individual under subsection (c)(1) of this section is medically verified immunization information by requiring the individual to submit evidence that includes a true and accurate copy of one or more of the following:
(1) the individual's medical record indicating the immunization history and including a provider's signature and the name and address of the provider;
(2) a vaccine-specific invoice from a health care provider for the immunization;
(3) vaccine-specific documentation showing that a claim for the immunization was paid by a payor;
(4) an immunization record signed by a school official; or
(5) an immunization history provided by a local or state immunization registry.
(e) The department may release the information collected in the registry under this section with consent of the individual or to any health care provider licensed or otherwise authorized to administer vaccines.
(f) A person whose immunization records are included in the registry under this section may request in writing that the department remove the information from the registry. The department shall remove the person's immunization records from the registry not later than the 10th day after receiving a request.
§100.10.Complaints.
(a) A person may file a complaint with the department related to the department's alleged failure to comply with a request for exclusion of an individual from the registry by mailing such a complaint to: Manager, Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Manager, Immunization Branch, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Branch at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written complaint within 30 days of that receipt of that complaint.
(b) A person may report an incident of discrimination for requesting exclusion of an individual from the registry, or for using an exemption for a required immunization, by mailing written notification to: Manager, Department of State Health Services, Immunization Branch, MC-1946, P.O. Box 149347, Austin, Texas 78714-9347, or by courier to Manager, Immunization Branch, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Branch at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written notification within 30 days of receipt of that notification.
(c) The department shall report to the Legislative Budget Board, the governor, the lieutenant governor, the speaker of the House of Representatives, and appropriate committees of the legislature not later than September 30 of each even-numbered year. The report shall:
(1) include the number of complaints received by the department related to the department's alleged failure to comply with requests for exclusion of individuals from the registry;
(2) identify all reported incidents of discrimination for requesting exclusion of individuals from the registry or for using an exemption for a required immunization;
(3) include the number of complaints received by the department related to the department's alleged failure to remove information from the registry as required by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event) after an event described in that section; and
(4) include the number of complaints received by the department related to the department's alleged failure to comply with written requests for the removal of information relating to first responders and their immediate family under §100.8 of this title (relating to First Responder Immunization Information).
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 28, 2008.
TRD-200803893
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 21, 2008
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The repeals are adopted under Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004, which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and Chapter 161, concerning the Immunization Registry; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.
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 28, 2008.
TRD-200803894
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 21, 2008
For further information, please call: (512) 458-7111 x6972
25 TAC §§129.1, 129.2, 129.4, 129.5, 129.7 - 129.13
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts the repeal of §§129.1, 129.2, 129.4, 129.5, and 129.7 - 129.13, concerning the voluntary registration and regulation of opticians without changes to the proposal as published in the March 7, 2008, issue of the Texas Register (33 TexReg 1959) and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The repeals are necessary to consolidate existing Professional Licensing and Certification Unit program rules in 25 Texas Administrative Code (TAC) Chapter 140, Health Professions Regulation. The new rules transfer and update existing language, and do not impose any new requirements or fees on applicants or licensees. The new rules also clarify that one registration certificate, not two, will be issued to a dual registrant, and eliminate language permitting the "carryover" of hours from one continuing education period to the next.
SECTION-BY-SECTION SUMMARY
The repeal of §§129.1, 129.2, 129.4, 129.5, and 129.7 - 129.13 is necessary to combine the Professional Licensing and Certification Unit rules in one chapter, 25 TAC Chapter 140, Health Professions Regulation.
COMMENTS
The department, on behalf of the commission, did not receive any comments regarding the proposed repeal during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the repeal, as adopted, has been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The repeal is authorized by Occupations Code, Chapter 352, which authorizes the adoption of rules regarding the regulation of opticians; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
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 25, 2008.
TRD-200803795
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 14, 2008
Proposal publication date: March 7, 2008
For further information, please call: (512) 458-7111 x6972
SUBCHAPTER G. OPTICIANS
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts new §§140.275 - 140.285, concerning the voluntary registration and regulation of opticians without changes to the proposed text as published in the March 7, 2008, issue of the Texas Register (33 TexReg 1961) and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The repeal of §§129.1, 129.2, 129.4, 129.5, and 129.7 - 129.13 and the new rules are necessary to consolidate existing Professional Licensing and Certification Unit program rules in 25 Texas Administrative Code (TAC) Chapter 140, Health Professions Regulation. The new rules transfer and update existing language, and do not impose any new requirements or fees on applicants or licensees. The new rules also clarify that one registration certificate, not two, will be issued to a dual registrant, and eliminate language permitting the "carryover" of hours from one continuing education period to the next.
SECTION-BY-SECTION SUMMARY
New §140.275 sets forth purpose and scope of the rules. New §140.276 includes definitions for terms used within the rules. New §140.277 lists the fees required for application, registration, renewal, and issuance of a duplicate certificate. New §140.278 describes application procedures and qualifications for registration as an optician. New §140.279 covers procedures related to the issuance of a certificate of registration, including duplicate certificates, titles, and expiration date of an initial certificate. New §140.280 sets forth information concerning registration renewal and late renewal, including renewal procedures for a registration on active military duty. New §140.281 sets forth continuing education requirements. New §140.282 sets forth procedures for a change of name or address. New §140.283 sets out violations, procedures concerning complaints and investigations, and actions the department may take against a person when violations have occurred. New §140.284 sets out the guidelines and criteria on the eligibility of persons with criminal backgrounds to obtain registration. New §140.285 details professional and ethical standards, including standards related to advertising by a registrant.
COMMENTS
The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The new rules are authorized by Occupations Code, Chapter 352, which authorizes the adoption of rules regarding the regulation of opticians; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.
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 25, 2008.
TRD-200803796
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 14, 2008
Proposal publication date: March 7, 2008
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts the repeal of §157.11, new §157.11, and amendments to §157.38 and §157.44, concerning the regulation of emergency medical services (EMS) providers, continuing education (CE) and instructors without changes to the proposed text as published in the March 28, 2008, issue of the Texas Register (33 TexReg 2655) and, therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The repeal and new §157.11 are necessary to implement two recent legislative changes to the Texas Health and Safety Code. The Texas Health and Safety Code, Subchapter A, §773.004 and §773.041 were amended by the 80th Legislature, Regular Session, 2007, (Senate Bill 10) to remove exemptions for physician-directed ground ambulance transfers of patients and to require that all ground transport of patients by stretcher be completed by a licensed EMS provider. Texas Health and Safety Code, §773.014, was amended by the 80th Legislature, Regular Session, 2007, (House Bill 2827) to require the department to adopt rules requiring EMS vehicles to be equipped with an epinephrine auto-injector device or similar device to treat anaphylaxis and requiring EMS personnel to complete continuing education training in the administration of anaphylaxis treatment. New §157.11 also contains some clean-up and other new language regarding mutual aide, volunteer EMS personnel exemptions, EMS medical director documentation, signage on ambulances, EMS provider advertisements, subscription program requirements, and EMS provider operating policies.
The amendments to the graphic in §157.38(c), EMS Continuing Education, added a new continuing education content area, regarding pediatrics, to maintain and enhance EMS personnel's knowledge of pediatric care. Also, continuing education hours were amended in two other areas of the graphic.
The amendments to §157.44, EMS Instructor Certification, clarify instructor responsibilities, curriculum requirements, clarify and add reasons for instructor disciplinary actions and surrender of instructor certification.
Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 157.11, 157.38 and 157.44 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
New §157.11 requires ground ambulance transfers of patients by stretcher to be performed by licensed EMS providers. New §157.11 requires EMS vehicles to be equipped with an epinephrine auto-injector device or similar device to treat anaphylaxis and requires EMS personnel complete continuing education training in the administration of anaphylaxis treatment. New §157.11 clarifies that EMS providers licensed in adjoining states responding to provide mutual aid in Texas may be exempt from holding a Texas EMS provider license, that EMS providers staffed with 75% volunteer personnel are exempt from payment of licensing fees, that EMS providers maintain documentation of medical director contracts, that EMS providers may obtain liability insurance from a company eligible to do business in Texas, that EMS vehicles must comply with federal specifications for body types, that current EMS provider license numbers must be displayed on the provider's ambulance vehicles, that EMS providers must place notices in the local media when providers are unable to provide continuous coverage, that clarifies the location of no smoking signs inside an ambulance, and that clarifies equipment requirements when lower level EMS vehicles are authorized to provide advanced level capabilities. New §157.11 clarifies that EMS provider subscription programs requirements will include written authorization from the highest local elected officials, written authorization by the county judge or city mayor as appropriate, and documentation of the beginning and ending dates of subscription enrollment periods, and requires EMS providers to develop, implement and enforce written operating policies.
Amendments to the graphic in §157.38(c) added a new CE content area, entitled: "Pediatric." The required number of hours for the content area entitled: "Minimum Units in Content Areas" was increased and the required number of hours for the content area, entitled: "Additional Units in any Approved Category" was reduced to reconcile the total number of CE hours required for recertification eligibility.
Amendments to §157.44 eliminated EMS skills verification orientation requirements, added wording to allow for EMS instructor examination by non-department entities, clarified curriculum requirements, itemized additional EMS instructor responsibilities, replaced language outdated as a result of the department's reorganization and further defined reasons for EMS instructor disciplinary action and surrender of the EMS instructor certificate.
COMMENTS
The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.
SUBCHAPTER B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES
STATUTORY AUTHORITY
The repeal is authorized by Health and Safety Code, §773.050, which allows the department to set the minimum standard for EMS providers, EMS personnel recertification and EMS instructors; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.
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 28, 2008.
TRD-200803879
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 28, 2008
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The new section is authorized by Health and Safety Code, §773.050, which allows the department to set the minimum standard for EMS providers, EMS personnel recertification and EMS instructors; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.
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 28, 2008.
TRD-200803880
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 28, 2008
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §773.050, which allows the department to set the minimum standard for EMS providers, EMS personnel recertification and EMS instructors; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.
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 28, 2008.
TRD-200803877
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 28, 2008
For further information, please call: (512) 458-7111 x6972
STATUTORY AUTHORITY
The amendment is authorized by Health and Safety Code, §773.050, which allows the department to set the minimum standard for EMS providers, EMS personnel recertification and EMS instructors; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.
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 28, 2008.
TRD-200803878
Lisa Hernandez
General Counsel
Department of State Health Services
Effective date: August 17, 2008
Proposal publication date: March 28, 2008
For further information, please call: (512) 458-7111 x6972