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PROVE Addresses Board of Health Objecting Second Set of Rules
September 11, 1998
Texas Board of Health
1100 West 49th Street
Austin, TX 78756
Fax (512) 458-7202
Dear Texas Board of Health:
Hello, my name is Dawn Richardson. I appreciate the opportunity to speak with you today as parent
who is greatly concerned with TDH's proposed rules implementing a statewide immunization tracking
system. I understand that the rules did not appear on today's agenda, however, it would be very
difficult for my family if I had to travel to Harlingen next month to speak with you.
The Texas Department of Health's initial attempt to legislate a statewide immunization tracking
system in HB 3054 would have mandated the tracking of our children where families didn't have a
choice. Doctors and insurance companies would have been required to give TDH our children's
confidential medical records for a nationally accessible database regardless of whether the parent
had given consent or not. Parents shared their concerns about their freedom of choice in health care
decisions for their family and their right to privacy of their children's medical information with
legislators. Consequently, TDH's controversial plans were thwarted when the legislature astutely
amended the legislation to require parental consent and limit medical record access and release.
Despite the law, TDH has repeatedly circumvented consent requirements. In February, TDH published
rules allowing them to "assume" parental consent. TDH wrote provisions which promoted
unrestricted data exchange. Objections from parents and legislators led TDH to withdraw the rules
and re-write them, and we just completed a second public comment period.
When I found my daughter in TDH's immunization registry on Monday, March 23rd, 1998, I
was angry, frustrated and felt betrayed by TDH. Neither my husband nor I had ever given our consent
at any time. We had worked hard within the system to protect our rights to keep our daughter out of
any immunization tracking database. Now it is evident that TDH employees not only lied to parents
and misled legislators, but they actually ignored the consent provisions of HB 3054 thus breaking
the law.
Just three days prior, I participated in a meeting at TDH where I represented a grassroots effort
by parents concerned about TDH's first set of proposed rules. I sat across a table from the director
of the Immunization Division Robert Crider, the Associate Commissioner of Disease Control Dr. Diane
Simpson, legal counsel for TDH Monty Waters, ImmTrac Administrator Vicky Cowling, and Government
Relations Representative to TDH Jim Audette. My most significant concern at the time was TDH's
unwillingness to implement the consent provisions in the law in their proposed rules. TDH employees
looked me in the eye and assured me that the "hypothetical" set of circumstances where my
child would get into this system without my consent would never occur. Imagine the shock and
repulsion I felt when I learned that not only was my daughter already in this registry along with
mine and my husband's social security numbers, but the ImmTrac employees had deliberately taken this
information without my consent from the confidential portion of my daughter's birth certificate
application. All of these employees of TDH knew they already had this information on my child and
never told me. If I hadn't found out on my own by calling up and asking questions of phone support
staff, I would have never found out.
What occurred to my family concerned State Senator Jerry Patterson enough to write an inquiry
letter to TDH to try and ascertain the real status of ImmTrac. The reply letter revealed that TDH
had entered 3.3 million children's records since 1995. Furthermore, over 700,000 records had been
created from the confidential portion of birth certificate applications without the parents'
knowledge or consent like in my daughter's case. The legislature had authorized the creation of the
registry unaware of TDH's covert premature efforts.
To make matters worse, TDH faxed my daughter's report to me based on a telephone request where
all I provided was my name, my daughter's name, her birthday and the county we live in. Once I found
my daughter was in the registry, I wanted to know what was recorded about her and us, so I asked TDH
to fax her report to me. How did TDH know it was really me? I hadn't signed a release form like the
law requires. Anybody could have impersonated me to get this information faxed to them.
How do I know so clearly that TDH broke the law and misled legislators? Almost a year earlier I
had testified before the Senate Health and Human Resources Committee with my concerns that parents
needed to be able to protect their children's private personal and medical information. Even though
Mr. Crider gave misleading statements concerning TDH's intentions for the registry (please see
appendix for my husband's letter submitted in the first comment period), the committee agreed, and
Senator Patterson submitted an amendment which required TDH to get written consent from a
parent to include their child in the registry and to release data from the registry to anyone. HB
3054 was signed into law on June 18th, 1997 by Governor Bush with these written consent
requirements. Despite all this, TDH misled me and "helped themselves" to my daughter's
personal records with the intention of releasing them to all registry users. They then faxed it out
over the phone to an unverified caller. TDH still needs to be held accountable for this.
My next opportunity to meet with TDH to discuss our concerns occurred on May 26th,
1998 at the state capitol with the Commissioner of Health Dr. Archer, ImmTrac Administrator Vicky
Cowling, and Government Relations Representative Jim Audette. Rebecca Rex, another concerned parent,
and I were accompanied by Senator Jerry Patterson and his staff including legislative aides Mark
Loeffler and Melvin Edwards. This effort by Dr. Archer to make himself available to concerned
parents was very much appreciated.
Just prior to the meeting, I was able to review a rough draft of a partial second set of proposed
rules which revealed another whole set of concerns. Some of these concerns are even more troublesome
in light of the fact that Dr. Archer, in his position of Health Commissioner for TDH, promised us
all in our meeting together on May 26th that these problems would be corrected in the new
rules. Based on his sincere attempts to listen to concerned parents, I believe he was not even aware
that his staff did not make the requested changes to TDH's second attempt at proposed rules. This
has dire implications for the agency and the Immunization Division's employees.
A large area of concern to us contained the broad release provisions. When Senator Patterson read
the consent language, he picked up the problems with the statements on the form allowing for release
of information to the "Commissioner or Designee" and as well the re-release to those who
administer and promote vaccines. Dr. Archer agreed. Not only have the rules left in this language,
but they've added even more recipients that were never approved by the legislature like DHS and past
and current health plans despite the verbal agreements that only the record from a paid claim should
be accessed by an insurance company.
Another crucial area of concern was restricting the registry to a Texas database by not allowing
for the out of state release of a child's records since TDH could not guarantee the security and
confidentiality of a Texan's confidential medical records on a database out of state. This was
additionally agreed upon, but left in the rules. I am especially concerned with the implications
this has for national database plans. To better understand my concerns, you may review my written
testimony against the National Immunization Registry Plan posted on the Centers for Disease
Control's National Immunization Registry Clearinghouse web site at http://www.cdc.gov/nip/registry/i_pubcom.htm.
This national system is clearly not in the best interest of Texas citizens.
The third area we discussed were forceful consent forms. Mark Loeffler had copies of the consent
forms TDH uses for the registry. The forms bundle vaccine consent with registry consent. In other
words, as long as you get a shot and have to sign the shot consent form, you are included in the
registry by default in spite of your wishes. This was supposed to be taken care of in the rules as
well, but it hasn't been.
And lastly, we discussed the vulnerable positions parents are in during the birth process and
obtaining consent at birth was not appropriate. It was pointed out by Melvin Edwards that parents
are not in an emotional or physical state of mind while in active labor to consent to this system. I
feel TDH knows this and is taking advantage of the parent to gain consent by default. Additionally,
TDH is only proposing a yes/no check box on the birth certificate application. This is not informed
consent. It was originally Dr. Archer's opinion that they could address this by getting parents
printed material to take home and read, but after we discussed the other problems with birth
certificate consent which are outlined below, he agreed this could be inappropriate.
Unfortunately, at the time of our meeting, we were only provided with a subset of the final
proposed rules. During the recent public comment period which just ended Monday, I uncovered many
other concerns. Although on the surface this set of proposed rules appears to protect private
information, closer examination reveals loopholes which compromise informed consent and the
legislative protections governing the security, collection, and release of confidential medical
information. In the interest of time today, I will not go through my specific concerns with the
rules, but I have provided all of you with copies in an appendix to my letter so that you may read
them at your convenience.
My visibility with the public regarding this immunization tracking issue has brought about some
surprises. I was recently appointed as Legislative Director for Immunization Tracking Systems for
the National Vaccine Information Center. It is humorous and disturbing at the same time because I
was not appointed because of my legal training - I don't have any. I was appointed because of my
"on the job training" I received while being obligated as a concerned parent to speak up
against these actions by TDH. In addition, this visibility has brought parents from around the state
to contact me with their personal stories and concerns regarding immunization tracking and forced
vaccinations. I am including these notes for your benefit as well. I think they will give you an
idea how real families are being treated and not respected. I also have a written statement by
another concerned parent who has been involved with this issue since the introduction of HB 3054 as
well, Rebecca Rex.
I will close my comments today by respectfully asking you to reject these rules in your upcoming
vote until all of these concerns are resolved. I don't know if it means anything to you, but my
personal experience with this agency regarding this issue has been very unpleasant and emotionally
trying for my family. It will take a tremendous turn around in the behavior and attitudes of TDH
employees to restore my trust in this agency. Thank you for your time and willingness to listen.
Sincerely,
Dawn Richardson
Appendix A
Objections to Proposed Rules Implementing a Statewide Immunization Tracking System
PREAMBLE I OBJECT TO FORMS TO DECLINE PARTICIPATION IN THE REGISTRY.
No Forms for Non-Participation
The fifth paragraph of the preamble to the proposed rules states that doctors will have the added
expense of providing forms to patients to decline participation in the registry. This is not an
acceptable practice when the law requires the burden of action on TDH to obtain consent to
participate, not the burden on the parent to sign a form to decline participation. According to the
statute, parents who don't want to have their children in the registry should not have to do
anything.
DATA COLLECTION I OBJECT TO THE AMOUNT OF DATA TDH IS REQUIRING AND THE LENGTH OF TIME THEY
ARE STORING IT.
Too Much Data
The law defines the information that can be collected by TDH to be: the child's name and date
of birth; the types and dates of immunization; and the immunization provider's name and address
(Texas Health and Safety Code Section 161.008 (b)). Despite this definition, the proposed rules
in Section 100.5 (b) (f) and (g) call for the additional reporting of the provider's business
telephone number; the child's gender, address, and social security number; the names and
relationships of parent(s), guardian(s), or managing conservator(s); the mother's maiden name;
and evidence to immunity to vaccine preventable disease. The Texas Legislature previously
rejected the proposed inclusion of such information in the registry when it amended HB 3054 to
incorporate the limiting language reflected in Texas Health and Safety Code Section 161.008 (b).
I object to TDH's attempt to obtain information through its rules that the Legislature has
already denied by statute. TDH must not be allowed to circumvent the privacy protections built
into the statute by exceeding its statutory authority to gather information.
Holding Data Too Long
The law establishes a "childhood immunization registry" not an adult immunization
registry (Health and Safety Code Sections 161.007 (a) and (b)). However, the proposed rules
allow TDH to keep children's data until they reach the age of 21, without any option for
withdrawing themselves from the registry after they reach the age of 18 (sections 100.1 (10),
100.2 (b), 100.5 (a)). TDH should not be allowed to keep an immunization record on the registry
past the child's 18th birthday.
Optional Data Unclearly Labeled
Section 100.5 (h) of the rules states that "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." However, TDH's forms mislead providers and parents by
failing to indicate which information is required and which is optional. The proposed rules too
often give discretion to providers rather than parents regarding the submission of patients'
personal information to the registry. For example, instead of informing parents that certain
information is optional and leaving the decision to them, the proposed rules instruct providers
to report the information "if available." Most providers will have all the data
available and will supply it without parents ever having a chance to decline the optional items.
The rules should provide that all unrequired data must be clearly labeled "optional."
DATA RELEASE I OBJECT TO TDH'S UNRESTRICTED REGISTRY DATA RELEASE AUTHORIZATIONS.
Too Many Recipients
The law authorizes data to be released only to a public health district, a local health
department, the child's physician, and a school or child care facility in which the child is
enrolled (Health and Safety Code Section 161.008 (c) (2)). The proposed rules unacceptably
expand the list of registry data recipients, to include "the Commissioner of Health or
designee" (section 100.2 (a) (2) (E)). This gives the Health Commissioner unlimited
discretion to release registry data to anyone. This kind of open-ended authorization must not be
allowed.
The proposed rules have also added past and current health care plans to the list of registry
data recipients (section 100.2 (a) (2) (G)) without statutory authorization. A health plan
receives all the data it needs to process an immunization related claim from the child's
provider, so it is especially unnecessary for a past or present insurance company to be able to
access the child's entire registry file.
TDH is also attempting to give registry access to the Texas Department of Human Services
(DHS) (section 100.2 (a) (2) (D)) without statutory authorization. The majority of people in the
state are not on public assistance programs, and DHS's public health immunization providers
already have access to the registry. DHS, as an agency, was not authorized release privileges by
the legislature and therefore should not be allowed release privileges by TDH.
DATA RE-RELEASE I OBJECT TO TDH'S UNRESTRICTED RE-RELEASE OF DATA ON A CHILD TO
"ADMINISTRATORS AND PROMOTERS" OF VACCINES AND OTHER STATE REGISTRIES.
Unrestricted and Uncontrollable Data Exchange
Under Texas law, only the Health Department is authorized to release a child's confidential
immunization record. Release is authorized only to a public health district, a local health
department, the child's physician, the child's school or child care facility , or a parent.
However, the proposed rules purport to expand this list of recipients without statutory
authority. Furthermore, the law does not authorize any of these recipients to re-release
information from the registry (Health and Safety Code Section 161.008 (c) and (d)). Although the
law was written this way to protect the private information, the proposed rules attempt to give
sweeping authority to all registry users to re-release any child's confidential record to
unknown, unlimited and unrestrained "entities and individuals who both administer and
promote immunizations and the immunization registries of other states" (Section 100.2 (a)
(3)). This includes out-of-state recipients who are beyond the reach of Texas law and TDH rules.
The effect of these proposed rules is to promote uncontrollable data exchange without
security guarantees. I object to this gross, unauthorized and abusive expansion of data exchange
under the proposed rules. At a minimum, all registry users should be required to enter an
enforceable agreement with TDH that they will comply with all Texas laws and rules concerning
the uses of registry information. No data release outside of Texas should be allowed.
CONSENT I OBJECT TO TDH'S INADEQUATE EFFORTS TO OBTAIN THE STATUTORILY REQUIRED WRITTEN
INFORMED CONSENT FROM THE PARENT FOR REGISTRY INCLUSION AND RELEASE OF RECORDS.
Not at Birth
The proposed rules and current practice of TDH having a consent "check box" on
birth certificates forces parents to make an unrelated decision at a very inappropriate time.
(Section 100.2 (b)). Not only are many women emotionally and physically exhausted during and
after labor, but most are under the physical and mind-altering effects of pain management drugs
and anesthesia. In addition, birth certificates are retyped by hospital staff, and there are
documented instances of hospital staff changing a parent's registry consent status from
"no" to "yes". This has lifetime repercussions for families who did not want
their children's confidential information released. An immunization registry has nothing to do
with vital statistic data. Birth certificate consent appears to be an attempt of TDH to push
inclusion by catching families at a vulnerable time when they are unlikely to give truly
informed consent. Consent at birth is inappropriate and should not be allowed to continue now or
in the future.
Current Forms Force Inclusion
HB 3054 initiated the statewide immunization registry on September 1, 1997. Even
though this law authorizes only a purely voluntary registry, the consent forms TDH continues to
use today (C-90, C-97, C-106, etc.) bundle immunization consent with registry consent under one
signature. In other words, all parents who consent to having their child immunized are forced by
default into the registry. This puts the burden on parents to discover they have the right to
withdraw consent and to contact TDH to withdraw. There are documented instances of families
being bullied and misled by doctors, nurses and school health staff into believing they had no
choice because their consent to the administration of vaccine automatically would include them
in the registry. Additionally, the current consent forms do not inform the parent of everyone
who will have access to their child's personal information or about their right to later
withdraw consent and how to do so. Not only should current consent forms be replaced
immediately, but TDH should be required to contact every family forced to be included in the
registry in this manner since September 1, 1997 with a new separate registry consent form that
includes withdrawal information and release disclosures.
No "Grandfathering" of Data
The legislative basis for the registry, HB 3054, which reads "An Act relating to the creation
of an immunization registry", did not authorize the registry to be initiated until
September 1, 1997. In fact, TDH implemented the registry years before it was authorized to do so
by the Texas Legislature. None of the statute's privacy protections were in place during that
time. For example, the Texas Health and Safety Code expressly states in Section 161.008 (a) (3)
that TDH must have parents' consent before it may add their children to the registry. In fact,
since 1995 TDH has entered at least 3.3 million children into its registry wholly or largely
without any parental consent whatever. Despite these unauthorized and abusive actions, and
although TDH has admitted that it cannot verify the required consent for these records, the
proposed rules in section 100.6 (a) state that TDH will keep information in the registry that
was entered prior to September 1, 1997. TDH's half-hearted proposal for contacting the parents
of these children is to post notices in doctor's offices which state that they may already be
in the registry. This is unacceptable. TDH should instead be required to directly contact those
families and either obtain truly informed consent in writing or delete those records from the
registry.
Not One Time Only
Federal law and the Vaccine Injury Compensation Program (VICP) require parents to be provided
with printed information about the benefits and risks of a vaccine before it is administered to
their child, as well as how to monitor and report an adverse vaccine reaction. Section 161.008
(c) of the Texas Health and Safety Code requires that TDH may obtain or release registry data
only with the prior written consent of a parent. However, the proposed rules state that
"consent must be obtained one time only and is valid until the child attains 21 years of
age" (Section 100.1 (10)). Further, this one-time consent is to include "past,
present, and future information" concerning the child's immunizations (Section 100.2 (a)
(2)). This proposed rule appears to be an attempt by TDH to force inclusion by default rather
than to obtain true informed consent. A "one time only" consent is not adequate as
children change providers many times. How will a new doctor know whether consent was obtained at
birth or from another provider, or was denied? Since other federally mandated forms are already
being distributed at the time of vaccination, it is convenient and necessary for the protection
of our children's information that written consent for the registry be obtained at the time of
each vaccination. There are over 200 new vaccines being developed, and since no parent knows
what future vaccines will be required, consent for registry inclusion and release should be
obtained with each new vaccine being administered.
MISSING PROTECTIONS I OBJECT TO TDH'S LACK OF PROTECTIONS IN THE RULES. DATA SECURITY AND
PENALTIES ARE INADEQUATE, NO LIMITS EXIST TO STOP THE HARASSMENT OF AGGRESSIVE OUTREACH AND
COMPLIANCE PROGRAMS, AND THERE ARE NO PROTECTIONS AGAINST PUNITIVE MEASURES FOR FAMILIES CHOOSING
NOT TO PARTICIPATE IN THE REGISTRY.
Inadequate Data Security
Immunization registry records are confidential medical information (Health and Safety Code
Section 161.007 (a) (1)). However, the proposed rules require only "immunization providers,
health plans, and TDH" to "maintain the confidentiality of all immunization
reports" (Section 100.9 (b)). In addition, the rules require only providers to sign
confidentiality statements, register, and be provided with security levels, a user ID, and a
password (Section 100.11 (a-c)). Why has TDH left out schools, day care facilities, and other
registry users from these security and confidentiality requirements? The way this section of the
proposed rules is written allows virtually anyone at a registry user's location to have
unsecured access to the personal information in any child's record. All registry users, not just
providers, must be required to maintain the confidentiality of an immunization record.
Missing Penalties
The proposed rules do not prescribe any penalty for anyone who fraudulently or wrongfully
obtains or releases registry information when a parent has not given written consent. Without
enforceable penalties, there are no incentives for providers and health plans to take the
measures necessary to prevent entries and releases of registry information about children from
families who object to being tracked, and other similar abuses. At a minimum, the rules should
reflect the applicable penalties provided for in the Texas Health and Safety Code as well as
provide for exclusion from access to the registry system.
No Limits on "Notices"
TDH drafted the language of HB 3054 which authorizes intrusive notification and compliance
measures. The bill states that TDH can provide notices "by mail, telephone, personal
contact, or other means" of "overdue" immunizations according to the department's
schedule (Health and Safety Code Section 161.007 (e)). House and Senate committee hearing
recordings reveal that TDH never informed the legislature of the immunization registry's home
telephone auto-dialer machines and CDC sponsored pilot programs where vaccination vans show up
on the doorstep of families who don't respond to the automated calls in a "timely"
manner. Since the statute does not clearly define or place limits on "personal
contact", "other means", or frequency of notices, the rules need to include some
protections and limits. Given that the registry does not provide for exemption information,
parents declining certain immunizations for medical, religious, or conscientious reasons could
be continually harassed.
Missing Protections for Not Participating
Since inclusion in the registry is voluntary, the rules should state that parents who refuse
consent will not be penalized, retaliated against, or in any way harassed. Families choosing not
to participate in the registry must be protected from any backlash by registry users, including,
but not limited to: insurance companies, health maintenance organizations, other organizations
that pay or reimburse claims for immunizations, physicians, public health offices, employers,
schools, or child care establishments.
DATA FORMAT I OBJECT TO TDH REQUIRING IMMUNIZATION REGISTRY DATA FOLLOW HEALTH LEVEL 7 (HL7)
FORMAT.
No National and International Monitoring of Vaccination Status
The proposed rules state the HL7 format will be used by the registry for automated data
exchange (Section 100.8 (b)). HL7 format has a format specific to immunizations that allows for
the sharing of records and monitoring of vaccine status nationally and internationally. This
data exchange format was chosen by TDH because of their intentions to release our children's
records to databases outside of Texas despite strong parental objections and absence of
statutory authority. The HL7 format promotes this.
AGENTS I OBJECT TO TDH DEFINING ALL PROVIDERS AS AGENTS FOR THE TEXAS DEPARTMENT OF HEALTH
FOR THE PURPOSES OF THE IMMUNIZATION REGISTRY.
No Agents
There is no statutory authority for making providers the agents of TDH for registry purposes,
and the implications of so doing are unclear. Defining providers as agents of TDH could shield
them from legal liability under their statutory obligation to maintain doctor/patient
confidentiality as well as other wrongful uses of the registry, such as reporting or disclosing
private information without securing written consent (Section 100.1 (3)). I request that TDH
explain its intentions and the potential ramifications of making providers its agents for
registry purposes.
Appendix B
Notes From other Parents Mistreated about the Registry and Immunizations
----Original Message-----
To: [email protected] <[email protected]>
Date: Tuesday, August 18, 1998 8:25 AM
Subject: HELP!
>Dear Dawn;
>When (Lisa) enrolled at the local public high school, a school nurse
>began really harrassing her about getting a measles shot.This harrassment
>went on for several weeks as I was tied up and unable to get her to get
>the shot any sooner. She was called out of class and into the
>principal's office and pressed in a threatening way. The nurse wrote me
>a letter, which was the only letter I ever received, yet it said "final
>notice" all over it and it was covered with an almost rediculous amount
>of red pen marks, astericks and yellow highlighting. The letter was
>threatening. ( I still have the letter.) Actually, her letter stated
>that an MMR was required, but I knew that the law only required a measles
>booster.
>
>I decided to take (Lisa) to the TDH clinic in Corsicana for the shot. I
>called ahead to ask if I would be required to sign a medical release,
>because I do not believe that I should be required to sign a medical
>release when I am being forced by law to get the immunization against my
>will. I was assured that no such release would be required.
>
>When I arrived at the clinic, I was questioned as to why I didn't bring
>the letter from the school. (I truly just forgot it!) This seemed to be
>a big problem, and they wouldn't administer the shot at first. The nurse
>that I spoke with checked with first one supervisor and then another,
>each time stating that there was "a problem." I didn't understand what
>the "problem" was. They kept saying that they couldn't "just blindly
>immunize" her without the letter from the school. (I didn't understand
>why they could take the school's word, but not mine as her parent.) They
>tried to call the school nurse but couldn't get her. They finally agreed
>to give her the immunization, but only after I called my home and had my
>son read the letter over the phone.
>
>Then, of course, I was presented with not only a medical release, but a
>release which contained a statement that said that I gave my permission
>for them to put (Lisa) into a computerized tracking system.I am
>vehemently opposed to my children being entered into any tracking system
>because of privacy issues. I questioned the release and the permission
>statement, and I was treated very unkindly by the attendant. I was told
>that they would not give the shot unless I signed the form. I was told
>that I had no choice in the matter. When I asked if I could line out the
>portion of the release which had the permission statement, the attendant
>laughed and said that it didn't matter how I altered the form, that they
>would just put it into the computer that I signed and gave permission.
>The original form and how I had altered it would be irrelevant. I
>expressed my unwillingness to sign a false statement under duress. The
>entire release was a false statement for me in this situation, because I
>didn't want to get the immunization in the first place. To sign a
>statement that states otherwise is signing a false statement. I
>expressed to the attendant that I didn't want the shot at all, but was
>merely obeying the law. The attendant told me that it really didn't
>matter what I did or didn't do, or did or didn't think, she had orders to
>put the information into the computer, and that was what she was going to
>do, whether I liked it or not. I also asked for a measles shot only, but
>was told that all the clinic had was an MMR. She said that they didn't
>have the measles shot by itself, even though it was listed on the
>clinic's card, so I was forced to get the MMR. I left truly upset, and I
>felt like I had dealt with the Gestapo. I truly couldn't believe that
>this had happened to me in America.
>
>That's my story. Let me know if you are able to forward my story for me,
>or whether I need to do it myself.
>
>Thanks very much.
When I was pregnant with my first child, I was asked if I planned to have him vaccinated. It was
an issue I had not considered. I began to research and gather abundant literature on the topic. I
then made the informed decision not to vaccinate my child because I was very concerned about the
potential harm it could cause. I believed the risks outweighed the benefits.
Upon discharge from the hospital, after the birth of my son, I learned he had been injected with the
Hepatitis B vaccine. When I questioned why, the nurse showed me a consent form that bore my
signature. I did not recognize the form but I had indeed signed it. I was told that I had received
it along
with the other forms of consent (i.e. for delivery, blood transfusion, etc. ) all of which I
received during active labor.
I was extremely frustrated and angry because the mistake that had been made could not be corrected.
The shot could not be taken back. I had made my decision on the matter. I had done my part and
educated myself beforehand. I thought I was prepared. What I was not prepared for was to be
blindsided
with a consent form while I was in a physically, mentally, and emotionally compromised situation.
I was adamantly opposed to my child receiving that vaccination, however, I was somehow coerced into
consenting to it simply by the manner in which the form was presented. That is appalling.
At my son's two-month check-up. I expressed my concerns regarding the vaccinations to my
pediatrician. I anticipated a conflict so I merely told him I wanted to wait until my child was a
little older. I told him that I was not comfortable injecting numerous toxins in my 12 pound infant
son. I was prepared for a disagreement but assumed that since I was educated on the matter that he
would respect my decision. He did no such thing. His tone immediately became hostile and agitated.
He was extremely condescending and even accused me of abuse and neglect. He then abruptly told me to
find another doctor.
I was horrified. I was treated with absolutely no respect. My concerns were not even acknowledged by
the very person who is supposedly in the position to guide and educate. I was under the apparently
mistaken impression that I, as the mother of my child, was not only capable of, but rightfully
entitled
to, making informed decisions regarding his health care. I was faced not with an acceptance of my
choice, but rather with bullying and the use of scare tactics in an effort to force me to conform.
After I gave birth to my second child, I filled out the birth certificate form. There was a question
requesting consent to release my child's vaccination records to a state registry. I answered no to
this question. I was not familiar with this registry and did not want to release any of my child's
medical records that should rightfully be kept confidential. As I was proofing the form after it was
printed out by the computer I noticed the consent box was checked yes. I promptly requested that it
be changed to what
I had answered, "no". Again, I was treated with no respect. I was told "it's really
no big deal" in a very condescending manner. Although I was made to feel that my decision was a
ridiculous one, I stood my ground and expressed that I was quite capable and responsible enough to
keep track of my own
child's records.
This experience was also very frustrating. A woman is expected to make an important decision at a
very inappropriate time and place. When decisions are made in an uninformed, hurried manner it
inevitably results in conformity. In my experiences it. has become quite clear that we are not
merely encouraged but are expected to consent to whatever political agenda is currently on the rise.
And the field of health care, by its very nature, is the perfect forum for such agendas because
every mother wants to do what is
best for her child. Unfortunately, the information health care professionals provide is limited and
our society fosters ignorance rather than free thinking. Has our society digressed so far that we
freely support and accept the woman who chooses to end the life of her child while we in turn
criticize and alienate the woman who chooses to protect it?
Appendix C
Submitted Public Comments Illustrating TDH Misleads Legislature
Scott Richardson
913 Forest Trail
Cedar Park, TX 78613
(512) 918-9661
[email protected]
March 18, 1998
Robert D. Crider, Jr., M.S., M.P.A.,
Director, Immunization Division
1100 West 49th Street
Austin, TX 78756
Phone: (512) 458-7284
Fax: (512) 458-7288
[email protected]
Subject Proposed Rules on H.B. 3054, Immunization Registry, Not Acceptable (Public Comment)
Dear Mr. Crider,
I have some very serious concerns with the proposed rules. I am offended and disturbed that your
testimony before the Senate Health and Human Resources Committee on 5/16/97 reassured parents and
legislators that their privacy and confidentiality concerns would be addressed by TDH and yet the
proposed rules don't address these agreements despite the amended legislation.
It appears that you deliberately misled legislators and private citizens in order to get this
legislation passed. It is becoming clear that TDH never had any intention of addressing privacy and
confidentiality concerns. The proposed rules ignore the amendment adopted on May 22, 1997 and look
like the first version of H.B. 3054.
In order to clarify my concerns, I would like to revisit the Senate Health and Human Resources
committee hearing on May 16, 1997. I have reviewed the tape of this hearing, and unofficially
transcribed the testimony given.
The first person called to testify is Rebecca Rex, a parent from Houston, in opposition to the
current version of H.B. 3054. Her main concern is that even though a child may be exempt from the
registry, TDH still has the ability to access the child's medical records without consent of the
parent because the current legislation mandates insurance companies report this data to TDH.
She states that Texas law guarantees her child's medical records with her physician as
confidential unless she gives her doctor the ability to release those medical records to her
insurance company or somewhere else. She goes on to further clarify that, "We questioned the
amendment, we talked to the Texas Department of Health, and we have been told that although we can
exempt our child from the registry, the department still has access to our records. That hasn't been
clarified. It's my understanding that the registry and the department's access are two very
different things. I would like to be able to sign something in my physicians office giving him the
ability to release those records to the department just like do when I signed giving him permission
to release to my insurance company."
After some brief discussion, Senator Jerry Patterson asks, "My question is, this disclosure,
this medical information release without parents knowledge or consent, does it include the name of
the patient?"
Immunization director, Robert Crider is called as a resource witness.
Crider answers, "As it is now designed, we would get that information by name. But we
recognize, as madam chair outlined, the sensitivity with this. And as senator Moncrief asked, one
looks at epidemics that have occurred in the Texas areas, and we would not use that information to
recall or remind those people who don't want us to do that - that legislation as it is outlined
allows for us to not do that - does not permit us do that. It just gives the department, as well as
other providers, the ability to know where there are problem areas. And we at this point in any way
would not use that information to contact those parents or as some people might say harass
them."
Senator Jerry Patterson asked, "Two questions, #1 Why do you need the name - I can
understand demographics, I can understand certain types of demographic information such as age and
weight you know height, things like that, that might medically give some indication or a variety of
other demographic information. But the name, to me is completely of no significance or interest to
you."
Crider responds, "I think that would be negotiable sir, if we could have the other
demographic information in terms of ages, birth areas of where they live. I don't see how that would
be important to us to know the name."
Zaffirini says, "We could develop a floor amendment that would address those additional
concerns."
Crider responds, "Yes, and there is a statement that is required for all providers. It is a
vaccine information statement and we've included in there just a simple question 'Do you want your
child's information to be included in this registry or not?' We'll have to, through rules and regs,
develop that more fully, but the department sincerely understands people's personal desires even
though it might be a better benefit for the total population. So it is not our intent to use that
information if people don't want us to. We just want the aggregate data so that we know for planning
purposes more importantly in tight budget situations where money needs to go to try to help
children."
When Senator Zaffirini asks Senator Patterson if there were any additional concerns, he said,
"I am willing to vote this out, but of course there are no guarantees, but we have to insure
that unless the parent affirmatively offers up the name to be put in the registry, I mean that
medical information is private."
Senator Zaffirini asks Crider if that is acceptable to the Department. His reply is "Yes, as
long as we could get information that would give us the data ages or whatever."
Senator Zaffirini asks "Will you work with Senator Patterson to develop that amendment that
still gives you enough information that you need and satisfies the concerns of those who address the
issues of privacy and confidentiality?"
Crider answers, "Yes, if we are talking about non-identification by name, yes."
Senator Moncrief asks Rebecca Rex if this would satisfy her concerns as a parent. She says,
"As long the name and address of the child is kept confidential, I believe it would."
Crider interjects, "But I would like to clarify address being not say a specific mailing
address or residence, but a zip code or census track area."
Senator Patterson comments, "That's fine. Yes. That gives you some tracking data for certain
types of illnesses - a preponderance in certain areas and that's good."
Crider affirms, "Yes."
When Dawn Richardson, another parent opposing the current bill, is called, Senator Zafirini asks
her if she heard the previous conversation that took place and if the suggested changes would
alleviate her concerns.
Richardson replies, "Some of them, but not all of them. Right now, where my concern is, the
way the legislation is written, it is written that the parent has to contact TDH in order to let
them know that they do not want to be part of the registry."
Senators Patterson and Zaffirini state simultaneously that they are going to change that.
Then there is some discussion that in the interest of time things move forward, and that the
concerned parents work with the author of the amendment to make sure their concerns are addressed.
When asked if all of her concerns have been addressed, Richardson answers, "One last concern
that I have is that when parents are in the office of the doctor, that they are able to right then
and there decide and sign permission. I just want to state that and make sure the parents sign
permission in order to release their medical records."
Then all committee members vote H.B. 3054 forward with the agreement that a floor amendment will
be presented to cover the concerns that were discussed. Senator Jerry Patterson drafted this
amendment with the input of TDH and the concerned parents. HB 3054 was amended on May 22, 1997 to
address privacy and confidentiality concerns.
After reviewing the rules, the amended version of H.B. 3054, and the testimony given at the
committee hearing, I have concluded that TDH knowingly misled parents and legislators. The
agreements made by Robert Crider were never implemented into the rules.
The final version of H.B. 3054 addresses Rebecca Rex and Dawn Richardson' concerns brought
forward in their testimony; it was made clear that parents wishing for their children's records to
be included in the registry would sign a consent form. They would NOT be required to contact TDH if
they did not consent. It was also made clear that TDH would have no access to any personal
information about the child without the parent's consent.
Section 161.008 pertaining to the immunization record states that "the department, only with
the consent of a child's parent, managing conservator, or guardian may: 1) obtain the data
constituting an immunization record for the child from a public health district, a local health
department, or a physician to the child."
Section 161.007 section c) states that "An insurance company, health maintenance
organization, or other organization is not required to provide an immunization history to the
department under this subsection for a person for whom consent has not been obtained in accordance
with the guidelines adopted under Subsection (a) or for whom consent has been withdrawn."
Section 161.007 section d) states that "A health care provider is not required to provide an
immunization history to the department under this subsection for a person for whom consent has not
been obtained in accordance with the guidelines adopted under Subsection (a) or for whom consent has
been withdrawn."
The proposed rules violate this. In the preamble to the rules, Robert Crider writes, "Those
who wish to decline participation or withdraw consent must communicate this to the department,
involving minimal postage." The rules also state in section 100.3 Providers, Health Plans,
and Insurance Companies, that insurance companies can assume consent and they "shall"
provide an immunization history to the department.
Let's refer back to the testimony cited above given on May 16, 1997. Senator Patterson asked
Robert Crider if the release of medical information without a parent's consent included name, and
Crider answers in the affirmative. He goes on to say that TDH would not use that information to
"harass" parents. This is contradictory to a press release found on the TDH web page from
May 30, 1996 which mentions TDH had been awarded a Computerworld Smithsonian Award. "The system
also can provide parents with proof of their children's immunizations, and an added feature of the
program will be to automatically notify parents by phone when the records show that a child is due
or late in getting a required vaccination or booster." Apparently TDH does not consider
automated computer calls to homes to be "harassment."
The rules do not provide for vaccine exemption data entry. Since the department has no way to
know this, parents of exempt children will be harassed by the department providing "notices by
mail, telephone, personal contact, or other means to a parent, managing conservator, or guardian
regarding his or her child or ward who is overdue for a particular type of immunization according to
the department's immunization schedule." The rules do not state how often the notices will be
given or what "other means" could involve.
Robert Crider, in his testimony, agrees that TDH would not need personal data of name and address
for non-consenting parents. It is very disturbing that TDH writes rules that REQUIRE the collection
of "child's name and address, social security number, gender, child's date of birth, mother's
maiden name, and vaccine information," (Section 100.5 Reportable Information) and then allows
opportunities for the department to have access to that personal information of non-consenting
parents. Senator Patterson's amendment to H.B. 3054 addressed the privacy issues for consenting
parents by limiting what data can be collected by the department pertaining to immunizations.
Section 161.008 b) defines an immunization record in the registry to contain:
1. the name and date of birth of the person immunized;
2. dates of immunization;
3. types of immunization administered;
4. the name and address of the health care provider administering the immunization.
TDH has written the rules to usurp the legislation.
In his testimony, Robert Crider also states that TDH has provided a registry inclusion consent
statement in the vaccine information statements given by the doctor. The paperwork I have reviewed,
provided by TDH to our physician, bundles registry inclusion consent with consent of vaccination and
side effect disclosure. These consents need to require unique signatures. TDH should not be allowed
to strong-arm parents into an all or nothing vaccine related consent by bundling this all under one
signature. They are very different issues.
In conclusion, I would like to state that I am not happy with the continued insufficient actions
of this department to protect peoples' confidentiality and privacy rights with regards to
immunizations. I understand that TDH's motives include public health, but that does not give TDH the
right to mislead legislators and citizens and circumvent the protections in the laws that parents
and legislators worked so hard to provide. These proposed rules are not acceptable, and I request
the Texas Board of Health consider these comments when voting on this and future rules. The
Immunization Division of TDH has demonstrated a pattern of manipulative and deceptive practices with
regard to this immunization tracking system. It is time for it to stop.
Sincerely,
Scott Richardson
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