TITLE health-services

Part I. Texas Department of Health

Chapter 1. Texas Board of Health

Subchapter S. Requests for Providing Public Information

The Texas Department of Health (department) proposes the repeal of §§1.251-1.255 and new §1.251, concerning procedures for handling requests for public information. Specifically the new section describes how the department will handle requests for public information under the Public Information Act, Government Code, Chapter 552 (Act). The repeal is necessary because some of the existing language will be replaced by or clarified in new §1.251 and other existing language will be moved into the department's written policy on charges for records under the Act. Until September 1, 1997, §552.2611 of the Act required that charges for public records by a State agency be specified in rules. That section was repealed by Acts 1997, 75th Legislature (House Bill 951); therefore, the department's rules on charges are no longer required and charges may be addressed adequately through department policy.

John Burlinson, Acting Chief, Bureau of Support Services, has determined that for the first five-year period the proposed section is in effect there will be no fiscal implications to state or local government as a result of enforcing or administering the section as proposed.

Mr. John Burlinson has determined that for each year of the first five years the proposed section is in effect, the public benefit will be that staff will be able to handle public information requests more expediently; and that the policy and procedures will be clearly stated so the public can readily understand the time frame and the materials needed to comply with their public information requests. There is no anticipated cost to persons or small businesses, who may be required to comply with the section. There will be no effect on local employment.

Comments on the proposal may be submitted to John Burlinson, Acting Chief, Bureau of Support Services, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7720. Comments will be accepted for 30 days following the date of publication of this proposal in the Texas Register .

25 TAC §§1.251-1.255

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The repeal is proposed under the Public Information Act, Government Code, §552.230 which authorizes a state agency to promulgate reasonable rules of procedure under which public information may be inspected and copied efficiently, safely, and without delay; and Health and Safety Code, §12.001, which provides the Board of Health with authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the Commissioner of Health.

The repeal affects the Government Code, Chapter 552.

§1.251. Definitions.

§1.252. Charges for Providing Copies of Public Information.

§1.253. Access to Information Where Copies are Not Requested.

§1.254. Format for Copies of Public Information.

§1.255. Estimates and Waivers of Public Information Charges.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 20, 1998.

TRD-9805468

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


25 TAC §1.251

The new section is proposed under the Public Information Act, Government Code, §552.230 which authorizes a state agency to promulgate reasonable rules of procedure under which public information may be inspected and copied efficiently, safely, and without delay; and Health and Safety Code, §12.001, which provides the Board of Health with authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the Commissioner of Health.

The new section affects the Government Code, Chapter 552.

§1.251. Procedures for Handling Requests for Public Information.

(a)

The department requires that all public information requests be in writing unless there are special circumstances. Program staff may determine whether a verbal request may be accepted.

(b)

The program handling the request for public information will review the request and determine what records are requested; who is requesting the records; whether inspection or actual copies of the records are requested; and whether the requested records are open, confidential, or partially open and partially confidential. The Office of General Counsel is available to provide assistance in making these determinations.

(c)

To the extent possible the department will attempt to accommodate a requestor by providing information in the format requested. For example, if a requestor asks that information be provided on a diskette and the requested information is electronically stored, the department should provide the information on diskette. The department is not required to acquire software, hardware, or programming capabilities that it does not already possess to accommodate a particular kind of request except in accordance with the Public Information Act (Act), §552.231.

(d)

Provision of a copy of public information in the requested medium must not violate the terms of any copyright agreement between the department and a third party.

(e)

The program handling the request for public information must have the records ready for inspection or copies duplicated within 10 business days after the date the department received the request. If the program cannot produce the public information for inspection or duplication within 10 business days after the date the department received the request, the program will certify that fact in writing to the requestor and set a date and hour within a reasonable time when the information will be available for inspection or duplication.

(1)

Prior to the end of the 10 business days or the set date and hour, if applicable, the program will notify the requestor of the estimated costs if the costs will be over $100.

(2)

The program may require a cash deposit on requests for copies of public information which are estimated to exceed $100. The breakdown on deposit requirements are outlined in the department's operating procedures relating to charges for records under the Act.

(3)

All efforts should be made to process requests as efficiently as possible so that requested information will be provided at the lowest possible charge.

(4)

Full disclosure must be made to the requesting party as to how the charges were calculated.

(5)

All charges for public information in an amount of $100 or more must be paid to the department before the public information is actually provided to the requestor by inspection or duplication. On orders under $100, the program staff have the option to require prepayment before providing the information or they have the option to provide the information to the requestor along with a specially encoded remittance envelope for return of their payment.

(6)

If a request for information requires programming or manipulation of data pursuant to the Act, §552.231 and the department's policy established under that section, the time frame in this subsection will not apply until the requestor files the written statement described in the Act, §552.231 (d)(1) or (2). Once the written statement is filed, the program handling the request shall comply with this subsection.

(7)

When payment is required in advance of providing the public information, failure of the requestor to pay the costs of the copies within 30 days of notification of the estimated costs, or a longer period of time, if granted by the program, will be considered a withdrawal of the request for information.

(f)

The program, at its discretion, may provide public information without charge or at a reduced charge if the waiver or reduction of the charge is in the public interest, because providing the copies primarily benefits the general public, or if the cost for the collection of a charge will exceed the amount of the charge.

(g)

The department may set the price for publications it publishes for public dissemination or it may disseminate them free of charge. This rule and department policy do not limit the costs of departmental publications.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 20, 1998.

TRD-9805469

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


Chapter 103. Injury Prevention and Control

25 TAC §§103.1-103.4, 103.7, 103.8

The Texas Department of Health (department) proposes amendments to §§103.1 - 103.4, 103.7 - 103.8, concerning the reporting and control of traumatic brain injuries. Specifically, these amendments implement Chapter 893 of the 75th Legislature, including traumatic brain injuries as reportable injuries to the department. The amended sections cover purpose; definitions; list of reportable conditions; reporting requirements; confidential nature of case reporting; and investigations.

Specifically, the amendment to §103.1 adds traumatic brain injuries on the list of reportable conditions. The amendment to §103.2 adds three new definitions (health care entity, state trauma registry, and traumatic brain injury) and amends one other (spinal cord injury). The amendment to §103.3 adds traumatic brain injuries to the list of reportable conditions and specifies what the reports of injuries may include. The amendment to §103.4 clarifies the reporting requirements by specifying how submersion, spinal cord and brain injuries are to be reported, by whom, and how often; adds rehabilitation facilities as sentinels for spinal cord and brain injuries; adds language requiring hospitals to report admitted cases of spinal cord and brain injuries to the State Trauma Registry; adds language regarding the department to provide summary data to local and regional health departments; and adds language allowing the department to contact hospitals and rehabilitation facilities regarding suspected cases of reportable injuries. The amendment to §103.7 strengthens the confidential nature of case reporting to include all information and records related to injuries. The amendment to §103.8 adds language that provides for joint investigations of spinal cord injuries and/or brain injuries with the Texas Rehabilitation Commission and Texas Traumatic Brain Injury Advisory Board.

David Zane, M.S., Director, Injury Prevention and Control Program, has determined that for the first five year period that the sections are in effect that there will be no fiscal implications to state or local government as a result of enforcing and administering the sections as proposed.

David Zane has also determined that for each year of the first five years the sections are in effect, the public benefit anticipated as a result of enforcing the sections as proposed will be improved knowledge of the prevalence of injuries and an expanded ability to identify common causes of injuries in Texas. There is no anticipated effect on small businesses. The economic costs to persons who are required to comply with the sections as proposed will be the staff time to complete reporting requirements which is approximately 15 minutes per case (estimated $2.75 per case). There will be no impact on local employment.

Comments on the proposal may be submitted to David Zane, M.S., Director, Injury Prevention and Control Program, Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3180, (512) 458-7269. Comments will be accepted for 30 days following the date of publication of the proposed rules in the Texas Register .

The amendments are proposed under the Health and Safety Code, §92.002, which requires the Texas Board of Health (board) to adopt rules necessary to implement the reporting of injuries; and §12.001 which allows the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The amendments will affect the Health and Safety Code, Chapter 92.

§103.1. Purpose.

These sections implement the Texas Injury Prevention and Control Act, Health and Safety Code, Chapter 92, [ House Bill 343, 73rd Legislature, 1993, ] which authorizes the Texas Board of Health to adopt rules concerning the reporting and control of injuries. These sections also implement Chapter 893, 75th Legislature, 1997, which amends the Texas Injury Prevention and Control Act to include traumatic brain injuries as reportable injuries. Nothing in the rules shall be construed to preempt or impede the authority of a health authority, a local health department, a public health district, a municipality, or a county to conduct the same activities within its jurisdiction.

§103.2. Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1)

Board--The Texas Board of Health.

(2)

Case--A person in whom an injury is diagnosed by a physician, medical examiner, or justice of the peace, based upon clinical evaluation, interpretation of laboratory and/or roentgenographic findings, and an appropriate exposure history.

(3)

Commissioner--The commissioner of the Texas Department of Health.

(4)

Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3180.

(5)

Director--The director of the Texas Department of Health, who is the commissioner.

(6)

Health authority--A physician designated to administer state and local laws relating to public health under the Local Public Health Reorganization Act, Health and Safety Code, Chapter 121. The health authority, for purposes of these sections, may be the chief administrative officer of a public health district or a local health department, or the physician who is to administer state and local laws relating to public health.

(7)

Health care entity - A health care entity that is capable of treating an injured person. Health care entities include, but are not limited to, emergency medical service providers, hospitals, and rehabilitation facilities.

(8)

Injury--Damage to the body that results from intentional or unintentional acute exposure to thermal, mechanical, electrical, or chemical energy, or from the absence of essentials such as heat or oxygen.

(9)

Reportable injury--Any injury or condition required to be reported under this chapter.

(10)

Report of an injury--The notification to the appropriate health authority of the occurrence of a specific injury in a human, including all information required by the rules and forms promulgated by the Board of Health.

(11)

Spinal cord--That portion of the central nervous system which extends from the foramen magnum to the cauda equina. All nerve roots within the spinal canal are included.

(12)

Spinal cord injury - An acute, traumatic lesion of the neural elements in the spinal canal, resulting in any degree of sensory deficit, motor deficits, or bladder/bowel dysfunction. The neurologic deficit or dysfunction can be temporary or permanent. The following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes are to be used to identify cases of spinal cord injury: 806.0-806.9 and 952.0-953.9.

(13)

State Trauma Registry - A statewide database which documents and integrates medical and system information related to the provision of trauma care by health care entities.

(14)

Submersion injury--A drowning (a death resulting from suffocation within 24 hours of submersion in water) or near-drowning (survival for at least 24 hours after suffocation from submersion in water).

(15)

Suspected case--A case in which an injury is suspected, but the final diagnosis is not yet made.

(16)

Traumatic brain injury - An acquired injury to the brain, including brain injuries caused by anoxia due to near drowning. The term does not include brain dysfunction caused by congenital or degenerative disorders or birth trauma. The following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) diagnostic codes are to be used to identify cases of traumatic brain injury: 800.0-801.9, 803.0-804.9 and 850.0-854.1. The ICD-9-CM diagnostic code to be used to identify traumatic brain injury caused by anoxia due to near drowning is 348.1.

§103.3. List of Reportable Injuries or Conditions.

Spinal cord injuries, traumatic brain injuries and submersion injuries are reportable injuries. Reports of these injuries shall include, but not be limited to: patient's name, address, age, gender, race/ethnicity, name of health care facility, and name of attending physician, and may include patient's occupation and employer.

§103.4. Reporting Requirements.

(a)

The following persons or their designees shall report in writing within ten [ 10 ] working days all newly diagnosed cases or suspected cases of submersion injuries [ reportable injuries ] to the local health authority, or where there is no local health authority, the regional health authority:

(1)

a physician who diagnoses or treats a reportable injury or a suspected case of a reportable injury; [ and ]

(2)-(3)

(No change.)

(b)

The reporting physician, medical examiner, or justice of the peace shall make the submersion report in writing on a form or forms prescribed by the Texas Department of Health (department).

(c)

A local health authority or regional health authority shall transmit any reports of submersion [ reportable ] injuries to the Bureau of Epidemiology, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3180, on a weekly basis.

(d)

Transmission of submersion [ injury ] reports shall be made by mail, courier, or electronic transfer.

(1)-(2)

(No change.)

(e)

The following entities or their designees shall report all newly diagnosed cases or suspected cases of spinal cord injuries and traumatic brain injuries to the department:

(1)

a physician who diagnoses or treats a spinal cord injury or a traumatic brain injury or a suspected case of a spinal cord injury or a traumatic brain injury;

(2)

a medical examiner;

(3)

justice of the peace;

(4)

a hospital that admits a patient with a spinal cord injury or a traumatic brain injury or a suspected case of a spinal cord injury or a traumatic brain injury; or

(5)

a rehabilitation facility that admits or treats a patient with a spinal cord injury or a traumatic brain injury or a suspected case of a spinal cord injury or a traumatic brain injury.

(f)

The reporting physician, medical examiner, justice of the peace, or rehabilitation facility shall make the spinal cord injury report or the traumatic brain injury report (excluding reports of traumatic brain injuries caused by anoxia due to near drowning) in writing on a form or forms prescribed by the department within ten working days. A physician shall be exempt from reporting if a hospital admitted the patient and fulfilled the reporting requirements as stated in subsection (g) of this section.

(g)

The reporting hospital shall report the spinal cord injury or the traumatic brain injury (excluding traumatic brain injuries caused by anoxia due to near drowning) through electronic transmission via modem to the department's State Trauma Registry on at least a quarterly basis as described in Chapter 773 of the Health and Safety Code.

(h)

All entities listed in subsection (e)(1)-(5) of this section shall report a traumatic brain injury caused by anoxia due to near drowning as a submersion injury in the manner described in subsections (a)-(d) of this section.

(i)

The department shall provide annual summary data to the local and regional health authorities.

(j)

[ (e) ] The department may contact a medical examiner, justice of the peace, [ or ] physician, hospital, or rehabilitation facility attending a person with a case or suspected case of a reportable injury.

§103.7. Confidential Nature of Case Reporting.

(a)

All information and records relating to injuries [ individual injury case reports ] received by the local health authority or the Texas Department of Health (department), including information electronically submitted to the State Trauma Registry and information from injury investigations, are confidential records and not public records. These records shall be held in a secure place and accessed only by authorized [ health care ] personnel.

(b)

Information or records relating to any personal injury may not be released or made public on subpoena or otherwise, except that release may be made:

(1)

for statistical purposes, but only if a person and/or health care entity is not identified;

(2)

with the consent of each person and health care entity identified in the information released; or

(3)

(No change.)

(c)

(No change.)

§103.8. Investigations.

(a)-(d)

(No change.)

(e)

When the department investigates spinal cord injuries and traumatic brain injuries, the Texas Rehabilitation Commission shall be informed at the earliest opportunity.

(f)

When the department investigates traumatic brain injuries, the Texas Traumatic Brain Injury Advisory Board shall be informed at the earliest opportunity.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 20, 1998.

TRD-9805464

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


Chapter 169. Zoonosis Control

Subchapter C. Training of Animal Shelter Personnel

25 TAC §§169.61-169.65

The Texas Department of Health (department) proposes amendments to §§169.61-169.65, concerning the training of animal shelter personnel. Specifically, the sections cover the purpose of the sections, definitions, types of courses, prerequisites for course attendance, and course content. The amendments define the terms "satisfactory completion," and "animal control officer (ACO) course," delete definitions either for clarification or because they were already provided in the associated statute, describe the basic, advanced, and administrative ACO courses, modify the prerequisites for course attendance, and list the content of courses.

James H. Wright, D.V.M., M.P.V.M., Director, Zoonosis Control Division, has determined that for each year of the first five-year period the sections are in effect, there will be an estimated cost to state government of approximately $400 per year as a result of copying and mailing materials for additional administrative courses. The impact on local government would be an anticipated savings of $2,000 per year as a result of being able to send animal shelter/control personnel to a department administrative course, developed specifically for those occupations, instead of a generalized administrative training course provided by a commercial company.

James H. Wright also has determined that for each year of the first five years that the sections will be in effect, the public health benefit as a result of enforcing or administrating the sections would be decreases in human exposures to rabies, animal rabies cases, animal bites, pet overpopulation, and free-roaming animals, plus an increase in the humane treatment of animals, by increasing the accessibility of advanced and administrative training courses for animal shelter/control personnel through less restrictive course prerequisites. There will be no costs to small businesses or persons required to comply with these sections as proposed and no effect on local employment.

Written comments may be submitted to James H. Wright, D.V.M., M.P.V.M., Director, Zoonosis Control Division, 1100 West 49th Street, Austin, Texas 78756. Comment on the proposed rule will be accepted for 30 days following publication in the Texas Register .

The amendments are proposed under the Texas Health and Safety Code, Chapter 823, "Animal Shelters," §823.004, which provides the Texas Board of Health (board) with the authority to prescribe standards for training animal shelter personnel in animal health and disease control, humane care and treatment of animals, control of animals in an animal shelter, and transportation of animals; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The amendments affect Texas Health and Safety Code, §823.004.

§169.61. Purpose.

The purpose of these sections is to set standards and charge fees for the training of animal shelter and animal control personnel as to animal health and disease control, humane care and treatment, transportation of animals, and the control of animals in an animal shelter.

§169.62. Definitions.

The following words and terms, when used in this subchapter [ undesignated head ], shall have the following meanings, unless the context clearly indicates otherwise.

[ Animal control officer (ACO)

- Any person enforcing local ordinances and/or Texas Department of Health rules.]

[ Animal shelter

- An entity that legally collects, transports, keeps, or impounds stray, homeless, abandoned, or unwanted animals.]

[ Animal shelter personnel

- Any person, excluding veterinarians, working in an animal shelter.]

(1)

Animal Control Officer (ACO) course [ Course ] - An appropriate training session administered by the Texas Department of Health (department). There are three types of training: [ for ] basic [ animal control officers ], advanced [ animal control officers ], and [ or ] administrative [ animal control officers ].

(2)

Department - The Texas Department of Health [ (TDH) ]

(3)

Satisfactory completion - In order to satisfactorily complete an ACO course, an individual must attend all sessions and attain a passing score as set by the department on all post-course tests and/or practical exercises.

Courses [ Levels of Proficiency ].

(a)

The basic ACO course [ level ] gives introductory instruction in the topics listed in §169.65(a) of this title (relating to course content) [ encompasses the minimum proficiency required to do an acceptable job as an ACO ].

(b)

The advanced ACO course [ level ] covers the same topics as the basic course, but at a higher level and with emphasis on verbal communication skills [ encompasses the proficiency necessary for the optimum performance of duties as an ACO ].

(c)

The administrative ACO course [ level ] includes instruction in [ the ] supervisory and management skills necessary to implement and direct application of the concepts taught in the basic and advanced courses [ direct an animal shelter operation ].

§169.64. Prerequisites for Course Attendance.

(a)

Basic, advanced, or administrative. A person must[ : ] have applied [ apply ] for attendance with the department's Regional Zoonosis Control Program conducting the ACO course. Course enrollment will be based on space availability policies set by the region hosting the course .

(b)

Advanced. A person must have :

(1)

[ have ] satisfactorily completed a basic ACO course and, subsequently, worked or volunteered [ have been employed ] in animal shelter/ animal control activities [ work ] at least 2,000 hours [ one year ]; and

(2)

provided a recommendation from the individual's supervisor to include a statement that the person meets prerequisites for course attendance [ provide proof of high school graduation or equivalency ].

(c)

Administrative. A person must provide a recommendation from the individual's supervisor to include a statement that the person meets one of the following prerequisites for course attendance :

(1)

[ have ] satisfactorily completed an advanced ACO course; [ and ]

(2)

worked in an administrative position for two years; or

(3)

[ (2) ] [ have ] completed 60 [ 30 ] hours of college credit [ (each year of full-time employment as a supervisor or administrator in animal control may be substituted for five hours of college credit) ].

§169.65. Course Content.

(a)

The basic and advanced courses will include technical coverage of topics deemed pertinent to animal shelter/ animal control personnel by the department's Zoonosis Control Division (ZCD) including, but not limited to, animal health and disease control, humane care and treatment of animals, control of animals in an animal shelter, and the transportation of animals [ animal capture, restraint, impoundment and disposition; animal health, including zoonotic diseases; animal identification; sanitation and disease control; record keeping; shelter safety and occupational hazards; public relations; and animal laws and regulations relating to these topics ]. The administrative course will include instruction in [ coverage of ] supervisory and management skills necessary to implement and support the concepts taught in the basic and advanced courses .

(b)

There is no cost for attending a course. However, the Animal Control Officer Training Manual, which can be purchased from the department, is an essential reference.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 1998.

TRD-9805447

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


Chapter 181. Vital Statistics

Subchapter A. Miscellaneous Provisions

25 TAC §181.8, §181.9

The Texas Department of Health (department) proposes amendments to §181.8 and §181.9, concerning supplemental birth certificates and access to files. These sections revise and eliminate the word legitimation since the statutes no longer use this word and updates rule language concerning creation of a supplemental certificate of birth based on paternity determination. In addition, the rule directs the Bureau of Vital Statistics to notify the Office of the Attorney General, the Title IV-D agency for the State of Texas, of any supplemental birth records based on paternity.

Richard B. Bays, Chief, Bureau of Vital Statistics has determined that for the first five-year period the sections are in effect, there will be no fiscal implications to state government as a result of administering or enforcing the sections as proposed. There will be no fiscal implications for local government.

Mr. Bays has also determined that for each year of the first five years the sections are in effect, the public benefit will be the updating and improvement of rule language. There will be no effect on small business. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Richard B. Bays, State Registrar, Bureau of Vital Statistics, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3191, (512) 458-7692. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

The amendments are proposed under the Health and Safety Code, §191.003, which provides the Board of Health (board) with the authority to adopt necessary rules for collecting, recording, transcribing, compiling, and preserving vital statistics; §192.006 which provides that supplemental birth certificates shall be prepared and filed in accordance with board rules; and §12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The amendments affect the Health and Safety Code, Chapter 192.

Supplemental Birth Certificates [ Adoptions, Legitimations, and Paternity Determinations ].

(a)

When a supplemental [ an amended ] certificate of birth is prepared and filed based on adoption [ ,legitimation, ] or paternity determination, a copy of the new certificate shall be forwarded to each local registration official in whose office is recorded the original [ natural ] birth record of such child.

(b)

Wherever possible, the local registration official shall [ ,unless otherwise requested by the adoption parents, ] remove from his or her files the original [ natural ] birth record and forward it to the State Bureau of Vital Statistics. Where it is not possible to remove the original [ natural ] birth record, the local registration official shall cancel such record in such manner as to preclude the disclosure of any information contained therein. In its place he or she shall substitute the supplemental [ amended ] certificate of birth.

(c)

(No change.)

(d)

Where application is made for the filing of a supplemental [ an amended ] certificate based on paternity [ a marriage of the parents subsequent to the birth ], the applicant shall submit to the State Bureau of Vital Statistics a certified copy of the certificate of marriage indicating the subsequent marriage of the parents , an acknowledgment of paternity [ parentage ] prepared on a form prescribed by the Texas [ State ] Department of Health ,or a certified copy of the court decree if the information concerning the court decree is not already in the bureau files .

§181.9. Access to [ Sealed Legitimation and ] Paternity [ Determination ] Files.

(a)

After the supplemental [ supplementary ] certificate of birth based on [ legitimation or ] paternity [ determination ] is filed, any information disclosed from the record shall be made from the supplemental [ supplementary ] certificate, and access to the original certificate of birth and to the documents filed upon which the supplemental [ supplementary ] certificate is based shall not be authorized except upon order of a court of competent jurisdiction.

(b)

The Bureau of Vital Statistics shall notify the Office of the Attorney General, the Title IV-D agency for the State of Texas, in a manner agreed by both agencies of any supplemental birth records based upon paternity.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 1998.

TRD-9805439

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


Subchapter B. Vital Records

25 TAC §181.30

The Texas Department of Health (department) proposes new §181.30, concerning instructions and requirements for filing amendments to medical certification of certificate of death with a local registrar before submission to the department.

Richard B. Bays, Chief, Bureau of Vital Statistics has determined that for the first five-year period the section is in effect, there will be no fiscal implications to state or local government as a result of administering or enforcing the section as proposed.

Mr. Bays has also determined that for each year of the first five years the section is in effect, the benefits to the public, state, and local government will be beneficial and will aid the department in getting the medical amendment filed timely. There will be no effect on small business. There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment. The decedent's family members and funeral homes will be able to purchase amended certified copies of death certificates used in the application for insurance benefits, settlement of pension claims, and transfer of title of real and personal property.

Comments on the proposed rule may be submitted to Richard B. Bays, State Registrar, Bureau of Vital Statistics, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3191, (512) 458-7692. Public comments will be accepted for 30 days after publication in the Texas Register .

The new section is proposed under authority of the Health and Safety Code, §191.003, which provides the Board of Health (board) with authority to adopt necessary rules for collecting, recording, transcribing, compiling, and preserving vital statistics, and §191.028 which provides for filing amendments to certificates; and §12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The new section affects Health and Safety Code, Chapter 193.

§181.30. Instructions and Requirements for Filing of Amendments to Medical Certification of Certificate of Death with a Local Registrar.

(a)

An amending certificate (medical amendment) may be filed with the appropriate local registrar to complete or correct medical certification information on a certificate of death that is incomplete or inaccurate. The medical amendment must be on a form prescribed by the department.

(b)

A certificate described in subsection (a) of this section shall only be filed upon completion by the individual responsible for the certification of the original death certificate. If the original was signed by a physician, and a justice of the peace (JP) or medical examiner's office (ME) has subsequently conducted an inquest as authorized by the Code of Criminal Procedure, Chapter 49, the medical amendment may be filed by the JP or ME that conducted the inquest.

(c)

The local registrar shall carefully examine each medical amendment when presented for registration to determine if it is complete as required by the state registrar's instructions.

(d)

If the medical amendment is incomplete or unsatisfactory, the local registrar shall call attention to the defects in the return.

(e)

The local registrar shall number the medical amendment with the same file number assigned to the original death certificate. The local registrar shall sign each medical amendment to attest to the date the amendment is filed in the local registrar's office. The signature may be either handwritten or a facsimile stamp, and must be written or stamped with permanent black or blue ink. The medical amendment shall be attached to and become a part of the legal record of the death if the amendment is accepted for filing.

(f)

The local registrar shall make a photographic duplication of the medical amendment as authorized by the Local Government Code, Chapters 201 or 204. The copy shall be permanently preserved in the local registrar's office as the local record, in the manner directed by the state registrar.

(g)

The local registrar shall forward the original, properly filed medical amendment to the state registrar within ten days of filing.

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 17, 1998.

TRD-9805440

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236


Chapter 289. Radiation Control

Subchapter E. Registration Regulations

25 TAC §289.230

The Texas Department of Health (department) proposes an amendment to §289.230, concerning certification of mammography systems. The amendment to §289.230 incorporates changes to requirements on state certification, inspections, and violations as the result of House Bill 1534, 75th Texas Legislature, and requirements for the department to become an accreditation body in accordance with the federal Mammography Quality Standards Act. The revision includes new definitions supporting accreditation and accreditation fees. The amendment will give registrants an option of obtaining accreditation through the state instead of the American College of Radiology. Requirements for technologists and continuing education requirements for medical physicists performing surveys on mammography equipment to comply with federal standards have been added. Other minor grammatical changes were made to the section.

Mrs. Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration and Standards, Bureau of Radiation Control, has determined that for each year of the first five-year period the section will be in effect, there will be fiscal implications for state or local government who choose accreditation through the state as a result of enforcing or administering the section as proposed.

The department will receive an additional $21,600 in revenue for the first year, $108,000 in revenue the second year, and $252,000 for each remaining year of the first five-year period. Proposed fees for accreditation of a facility's first mammography unit are $720 and $345 for each additional unit. Fees for accreditation by the American College of Radiology are $900 for the first unit and $700 for each additional unit. The fiscal impact to state or local government entities that choose accreditation through the state will be a decrease in accreditation fees ranging from $180 to $4085 depending on the number of mammography machines possessed.

Mrs. McBurney also has determined that for each year of the first five years the proposed section will be in effect, the public benefit anticipated as a result of enforcing the section will be to ensure continued protection of the public and workers from unnecessary exposure to radiation by recovering the majority of the costs of the regulatory program from those entities possessing sources of radiation and by requiring appropriate training for individuals operating and evaluating mammography equipment. The amendment also provides mammography facilities an option for accreditation at a lower cost. The specific effect on small businesses and persons who are required to comply with the section as proposed will vary depending on the number of mammography machines authorized on a certificate of registration. There is no anticipated impact on local employment.

Comments on the proposal may be presented to Ruth E. McBurney, C.H.P., Director, Division of Licensing, Registration and Standards, Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3189, Telephone (512) 834-6688 or electronic mail at Ruth.Mcburney@tdh.state.tx.us. Public comments will be accepted for 30 days following publication of this proposal in the Texas Register . In addition, a public hearing to accept oral comments will be held at 9:00 a.m., Tuesday, May 26, 1998, in Conference Room N218, Texas Department of Health, Bureau of Radiation Control, located at the Exchange Building, 8407 Wall Street, Austin, Texas.

The amendment is proposed under the Health and Safety Code, Chapter 401, which provides the Texas Board of Health (board) with authority to adopt rules and guidelines relating to the control of radiation; and §12.001, which authorizes the board to adopt rules for the performance of every duty imposed by law on the board, the department and the commissioner of health.

The amendment affects Health and Safety Code, Chapter 401.

§289.230. Certification of Mammography Systems.

(a)

Purpose and scope [ Scope and purpose ].

(1)

This section provides for the certification of mammography systems and the accreditation of mammography facilities . No person shall use x-ray producing machines for mammography of humans except as authorized in a state certification of mammography systems issued by the agency in accordance with the requirements of this section and in a certificate issued by the United States Food and Drug Administration (FDA) .

(2)

(No change.)

(3)

In addition to the requirements of this section, all registrants are subject to the requirements of §289.112 of this title (relating to Hearing and Enforcement Procedures), [ §289.113 of this title (relating to Standards for Protection Against Radiation), §289.114 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), ] §289.201 of this title (relating to General Provisions), §289.202 of this title (relating to Standards for Protection Against Radiation) [ §289.122 of this title (relating to Registration of Radiation Machine Use and Services) ], §289.203 of this title (relating to Notices, Instructions, and Reports to Workers; Inspections), §289.204 [ §289.126 ] of this title (relating to Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services), and §289.226 of this title (relating to Registration of Radiation Machine Use and Services), [ §289.201 of this title (relating to General Provisions) ].

(b)

Definitions. The following words and terms, when used in this section, shall have the following meaning[ , ] unless the context [ text ] clearly indicates otherwise.

(1)

Accreditation - An official approval of a mammography facility by an accrediting body.

(2)

[ (1) ] Accreditation [ Accrediting ] body - An entity that has been approved by the FDA [ United States Food and Drug Administration (FDA) ] under 42 United States Code §263b(e)(1)(A) to accredit mammography facilities.

(3)

Agency - The Texas Department of Health.

(4)

[ (2) ] Automatic exposure control (AEC) - A device that [ which ] automatically controls one or more technique factors in order to obtain at preselected locations a required quantity of radiation . [ (See definition for phototimer). ]

(5)

[ (3) ] Average glandular dose - The value in millirad (mrad) or milligray (mGy) for a given breast or phantom thickness that [ which ] estimates the average absorbed dose to the glandular tissue extrapolated from free air exposures and based on fixed filter thickness and target material.

(6)

[ (4) ] Beam-limiting device - A device that [ which ] provides a means to restrict the dimensions of the x-ray field.

(7)

[ (5) ] Calibration of instruments - The comparative response or reading of an instrument relative to a series of known radiation values over the range of the instrument. [ ; or the strength of a source of radiation relative to a standard. ]

(8)

Calibration of machines - The measurement and specification of absorbed dose to a medium, or exposure in air, at a defined point in a radiation beam.

(9)

Certificate of Registration - A form of permission given by the agency to an applicant who has met the requirements for registration or mammography system certification set out in the Texas Radiation Control Act (Act) and this chapter.

(10)

Certification of mammography systems (state certification) - A form of permission given by the agency to an applicant who has met the requirements for mammography system certification set out in the Act and this chapter.

(11)

[ (6) ] Contact hour - 50 minutes of attendance and/or participation in instructor-directed activities.

(12)

[ (7) ] Continuing education - Acquiring contact hours by attendance and/or participation in lectures, conferences, or seminars; or participation in self-study programs.

(13)

[ (8) ] Control panel - That part of the radiation machine control upon which are mounted the switches, knobs, push buttons, and other hardware necessary for manually setting the technique factors.

(14)

[ (9) ] Dedicated mammographic equipment - Equipment that has been specifically designed and manufactured for mammography.

(15)

[ (10) ] Equipment (See definition for x-ray equipment).

(16)

[ (11) ] Facility - A hospital, outpatient department, clinic, radiology practice, mobile unit, an office of a physician, or other person that conducts breast cancer screening or diagnosis through mammography activities, including any or all of the following:

(A)

the operation of equipment to produce a mammogram;

(B)

processing of film;

(C)

initial interpretation of the mammogram; or [ and ]

(D)

maintaining the viewing conditions for that interpretation.

(17)

[ (12) ] Formal training - Attendance and participation in instructor-directed activities. This does not include self-study programs.

(18)

[ (13) ] Half-value layer (HVL) - The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value. In this definition, the contribution of all scattered radiation, other than any which might be present initially in the beam concerned, is deemed to be excluded.

(19)

[ (14) ] Interpreting physician - A physician who interprets mammographic images and who meets the requirements of subsection (d)(2)(A) of this section .

(20)

[ (15) ] Image receptor - Any device, such as a fluorescent screen or radiographic film, that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

(21)

[ (16) ] kV - Kilovolt.

(22)

[ (17) ] kVp - Kilovolt peak.

(23)

[ (18) ] mA - Milliampere.

(24)

[ (19) ] Mammogram - A radiographic image produced through mammography.

(25)

[ (20) ] Mammographic phantom - A test object used to simulate radiographic characteristics of compressed breast tissue and containing components that radiographically model aspects of breast disease and cancer. The phantom shall be approved or accepted by the FDA.

(26)

[ (21) ] Mammography - The use of x-radiation to produce an image of the breast on film, paper, or digital display that may be used to detect the presence of pathological conditions of the breast.

(27)

[ (22) ] Mammography system - A system that includes the following:

(A)

an x-ray unit used as a source of radiation in producing images of breast tissue;

(B)

an imaging system used for the formation of a latent image of breast tissue;

(C)

an imaging processing device for changing a latent image of breast tissue to a visual image that can be used for diagnostic purposes;

(D)

a viewing device used for the visual evaluation of an image of breast tissue if the image is produced in interpreting visual data captured on an image receptor;

(E)

a medical radiological technologist who performs a mammography; and

(F)

a physician who engages in, and who meets the requirements adopted by this section [ board rule ] relating to the reading, evaluation, and interpretation of mammograms [ mammogram ].

(28)

[ (23) ] mAs - Milliampere-second.

(29)

[ (24) ] Medical physicist - A person meeting the qualifications for a medical physicist specified in subsection (d)(2)(C) of this section.

(30)

[ (25) ] Medical radiological technologist - An individual specifically trained in the use of radiographic equipment and the positioning of patients for radiographic examinations and who meets the requirements in subsection (d)(2)(B) of this section.

(31)

[ (26) ] Mobile services - The utilization of [ Utilizing ] radiation machines in temporary locations for limited time periods. The radiation machines may be fixed inside a mobile van or transported to temporary locations.

(32)

[ (27) ] Mobile x-ray equipment (See definition for x-ray equipment).

(33)

[ (28) ] Optical density (OD) - A measure of the percentage of incident light transmitted through a developed film and [ ; it is ] defined by the equation . [ : ]

Figure: 25 TAC §289.230(b)(33)

[ Figure: 25 TAC §289.230(b)(28) ]

(34)

[ (29) ] Patient - Any individual who undergoes clinical evaluation in a mammography facility, regardless of whether the person is referred by a physician or is self-referred.

(35)

[ (30) ] Phantom image - A radiographic image of a phantom.

(36)

Physician - An individual licensed by the Texas State Board of Medical Examiners with license in good standing.

(37)

[ (31) ] Self-referral mammography - The use of x-radiation to test asymptomatic women for the detection of diseases of the breasts when such tests are not specifically and individually ordered by a licensed physician.

(38)

Severity Level I Violation - Examples of a severity level I violation include but are not limited to the following:

(A)

unqualified interpreting physician;

(B)

unqualified mammography operator;

(C)

unqualified medical physicist;

(D)

failing phantom images for over three months;

(E)

failure to perform processor quality control for over two months;

(F)

failure to have a quality control program in place and being performed; and

(G)

operating with a denied accreditation certificate.

[ (32)

SID (See definition for source-to-image receptor distance).]

(39)

[ (33) ] Source-to-image receptor distance (SID) - The distance from the source to the center of the input surface of the image receptor.

(40)

[ (34) ] Survey - An on-site physics consultation and evaluation of a mammography system performed by a medical physicist.

(41)

[ (35) ] Technical aspects of mammography - In relation to continuing education, some or all of the following subjects must be included:

(A)

anatomy and physiology of the female breast;

(B)

mammographic positioning;

(C)

technical factors used in mammography;

(D)

mammographic film evaluation and critique;

(E)

breast pathology; or [ and ]

(F)

mammographic quality assurance procedures.

(42)

Technique chart - A chart that provides all necessary generator control settings and geometry needed to make clinical radiographs when the radiography system is in manual mode.

(43)

[ (36) ] X-ray equipment - An x-ray system, subsystem, or component thereof. Types of x-ray equipment are as follows:

(A)

mobile x-ray equipment - x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled;

(B)

stationary x-ray equipment - x-ray equipment that [ which ] is installed in a fixed location.

(44)

[ (37) ] X-ray field - That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

(45)

[ (38) ] X-ray tube - Any electron tube that [ which ] is designed to be used primarily for the production of x rays.

(c)

Exemptions.

(1)

Mammography machines or cabinet x-ray units used exclusively for examination of breast biopsy specimens are exempt from the requirements of this section. These units are required to meet applicable provisions of §289.226 of this title and §289.227 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine) [ Texas Regulations for Control of Radiation (TRCR) Part 32 as adopted by reference in §289.116 of this title (relating to Use of Radiation Machines in the Healing Arts and Veterinary Medicine) and TRCR Part 42 as adopted by reference in §289.122 of this title ].

(2)

Xerography systems not used for detection of diseases of the breast are exempt from the requirements of this section. These units are required to meet applicable provisions of §289.226 of this title and §289.227 of this title [ TRCR Part 32 as adopted by reference in §289.116 of this title and TRCR Part 42 as adopted by reference in §289.122 of this title ].

(3)

Mammography systems not meeting the AEC requirements of subsection (e)(1)(G) of this section are exempt from this requirement if changes in the facility's technique chart reflect the density settings required to maintain the film density to within plus or minus 0.3 OD when the AEC is utilized. This change shall be addressed in the operating and safety procedures.

(4)

Mammography systems used exclusively for invasive interventions for localization or biopsy procedures or other unique mammographic imaging modalities are exempt from the requirements of this section [ part ] except for those listed in subsection (f)(6) of this section.

(d)

Operational controls for mammographic equipment.

(1)

Quality assurance.

(A)

Quality assurance program. Each registrant shall have a written, ongoing quality assurance program specific to mammographic imaging covering all components of the diagnostic x-ray imaging system to ensure consistently high-quality images while minimizing patient exposure. Responsibilities under this requirement include the following :

(i)-(iv)

(No change.)

(B)

Quality control. The registrant shall ensure that the following quality control items are performed at least as often as the frequency specified [ , ] when mammographic equipment is initially installed, replaced, or reassembled after moving . [ , and after tube or tube inserts are installed. ] When the results of tests performed in accordance with this subparagraph and subparagraph [ paragraph ] (C) of this paragraph do not meet the required acceptance criteria, corrective action shall begin within 30 days following the check and completed no longer than 90 days from commencement, unless authorized by the agency. Clinical images of mammographic examinations shall not be processed using a processor that deviates from the requirements of clause (i) of this subparagraph. A processor, other than the one commonly in use, may be used temporarily provided that the backup processor has been tested according to clause (i) of this subparagraph and has shown to be in tolerance, and a phantom image from the mammography system shall be acquired and run in the backup processor and evaluated for acceptable quality according to clause (iv) of this subparagraph, prior to the first patient exposure. Records of the quality control checks, including any correction or repair, shall be maintained for a minimum of two years for inspection by the agency. Films that [ which ] result from the performance of quality control tests shall be maintained for a minimum of 12 months.

(i)

Processor performance shall be evaluated by sensitometric and densitometric means and by developer temperature daily, or on each day of use for mammography, and the results recorded before the first patient exposure. The calibration of the densitometer must be checked every 12 months. Film processors utilized for mammography shall be adjusted to and operated at the specifications recommended by the mammographic film manufacturer, or at other settings such that the sensitometric performance is at least equivalent. For any registrant performing mammography and using film processors at multiple locations, such as a mobile service, each processor shall be subject to the requirements of this clause [ this requirement ]. Corrective action shall be taken in the event of the following [ when ]:

(I)

deviations exceeding plus or minus 0.15 in OD from established operating levels occur for readings of mid-density and DD on the sensitometric control charts; and/or

(II)

(No change.)

(ii)-(xvi)

(No change.)

(C)

Additional quality control requirements. When deviations are found, corrections or repairs shall be made in accordance with subparagraph (B) of this paragraph [ paragraph (1)(B) of this subsection ].

(i)-(iii)

(No change.)

(D)

Retention of clinical images. A registrant shall maintain and make available to a [ mammography ] patient of the facility any original mammograms performed at the facility until the earlier of either:

(i)

the fifth anniversary of the mammography; [ or ]

(ii)

the tenth anniversary of the mammography, if an additional mammogram of the same [ mammography ] patient is not performed [ within the five year period ] by the facility [ , the tenth anniversary of the mammography ]; or

(iii)

at the request of the [ mammography ] patient, the date the [ mammography ] patient's medical records are forwarded [ permanently transferred ] to another medical institution, to a physician of the [ mammography ] patient, or to the [ mammography ] patient. If the medical records are permanently transferred, this institution or physician will maintain and become responsible for the original film until the fifth or tenth anniversary as specified in clauses (i) and (ii) of this subparagraph.

(E)

Interpretation of clinical images. Each facility shall prepare a written report of the results of any mammography examination. Such report shall be completed as soon as reasonably possible and shall be :

(i)

[ be ] signed by the interpreting physician or [ be ] signed by electronic signature by the interpreting physician ; [ and include permission to use an electronic signature for the report; and ]

(ii)

maintained in the mammography patient's medical record in accordance with clauses (i) and (iii) of this subparagraph. A facility is not required to maintain copies of the lay person summary; and

(iii)

provided as follows:

(I)

to the mammography patient's physician(s);

(II)

if the mammography patient's physician is not available, the report shall be sent directly to the mammography patient and shall include a summary written in language easily understood by a lay person; or

(III)

if the patient is self-referred, such report shall comply with the provisions of paragraph (4) of this subsection.

[ (ii)

be provided to the mammography patient's physician(s); or]

[ (I)

if the mammography patient's physician is not available the report shall be sent directly to the mammography patient; and]

[ (II)

if such report is sent to the mammography patient, it shall include a summary written in language easily understood by a lay person; or]

[ (III)

if the patient is self-referred, such report shall comply with the provisions of paragraph (4) of this subsection; and]

[ (iii)

be maintained in the mammography patient's medical record in accordance with clauses (i) and (ii) of this subparagraph. A facility is not required to maintain copies of the lay person summary.]

(F)

Follow-up on interpretation of clinical images. Each facility shall establish procedures for reviewing outcome data from all mammography performed, including follow-up on the disposition of positive mammograms and correlation of surgical biopsy results with mammogram reports.

(G)

[ (F) ] Processing of mammographic images. Each registrant shall utilize the same processor for clinical mammographic and mammographic phantom images. Clinical images shall be processed within an interval not to exceed 24 hours from the time the first clinical image is taken.

(i)

Each clinical image shall be marked by a film flasher device, lead marker, or printed label in a non-critical area on the film. The information shall include, but is not limited to, facility name, patient's name, and the date of the film.

(ii)

Information shall also be maintained for each clinical image by utilizing a label on each film, recording on the film jacket, or maintaining a log or other means. The information shall include, but is not limited to, compressed breast thickness or degree of compression, and kVp.

(iii)

Facilities utilizing batch processing shall:

(I)

use a container to transport clinical images that will protect the film from exposure to light and radiation;

(II)

maintain a log to include each patient name and unique identification number, date and time of the first exam of each batch, and date and time of batch development.

(H)

[ (G) ] Xerography. Processing equipment for xerography shall be evaluated daily on each day of use before the first mammography patient exposure. Processing and maintenance of equipment shall be performed in accordance with manufacturer's recommendations. Xerography systems shall comply with all the requirements for mammography in this subsection and in subsection (e) of this section except for the following: subparagraphs (B)(i)-(iii), (vi), (viii), and (ix); (C)(ii) and (iii); and (G) of this paragraph [ subparagraph (B)(i)-(iii), (vi), (viii), and (ix) of this paragraph; subparagraph (C)(ii) and (iii) of this paragraph; and subparagraph (F) of this paragraph].

(2)

Personnel qualifications.

(A)

Interpreting physician. Each physician interpreting mammograms shall:

(i)

hold a current Texas license issued by the Texas State Board of Medical Examiners[ ; ] and be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or one of the other bodies approved by the FDA to certify interpreting physicians or have equivalent formal training and experience;

[ (I)

be certified by the American Board of Radiology, the American Osteopathic Board of Radiology, or one of the other bodies approved by the FDA to certify interpreting physicians; or]

[ (II)

have equivalent formal training and experience;]

(ii)

have had 40 hours of documented continuing medical education credits in mammography. (Continuing education credits shall be approved by the Accreditation Council for Continuing Medical Education [ (ACCME) ] or the Committee on Continuing Medical Education of the American Osteopathic Association.) Forty hours specifically devoted to mammography during residency will be accepted if documented in writing by the radiologist, and if the residency program has been approved by the Accreditation Council for Graduate Medical Education [ (ACGME) ] or the Council on Postdoctoral Training of the American Osteopathic Association [ (COPT-AOA) ];

(iii)

have [ the following ] initial experience six months preceding application in reading and interpretation of mammograms from the examinations of :

(I)

[ have read and interpreted the mammograms from the examinations of ] at least 240 mammography patients; or

(II)

[ have read and interpreted the mammograms from the examinations of ] at least 240 mammography patients under the direct supervision of a qualified interpreting physician; and

(iv)

have the following continuing experience:

(I)

reading [ read ] and interpretation of [ interpret ] mammograms from the examination of an average of at least 40 mammography patients per month over 24 months; and

(II)

participation [ participate ] in education programs, either by teaching or completing an average of at least five continuing medical education credits in mammography per year at intervals not to exceed three years.

(B)

Operators of equipment. The x-ray mammographic machines shall be operated by an individual currently certified as a medical radiologic technologist under Texas Civil Statutes, Article 4512m and who has completed a minimum of 40 hours of formal mammographic training as outlined in subsection (z)(1) of this section. Medical radiologic technologists shall accumulate an average of at least five continuing education hours per year in the technical aspects of mammography at intervals not to exceed three years.

[ (i)

The x-ray mammographic machines shall be operated by an individual certified as a medical radiologic technologist under Chapter 1096, Acts of the 70th Legislature, Regular Session, 1987 (Texas Civil Statutes, Article 4512m) who has completed:]

[ (I)

a minimum of 20 hours of formal mammographic training as outlined in subsection (o)(1) of this section;]

[ (II)

five years of documented experience performing mammography; or]

[ (III)

holds an American Registry of Radiologic Technologists (ARRT) Certificate of Advanced Qualification in Mammography.]

[ (ii)

Medical radiologic technologists meeting the requirements of clause (i)(I)-(III) of this subparagraph shall accumulate an average of at least five continuing education hours per year in the technical aspects of mammography at intervals not to exceed three years.]

(C)

Medical physicist. The person evaluating the performance of mammographic systems in accordance with these regulations shall hold a current Texas license under the Medical Physics Practice Act, Article 4512n in diagnostic radiological physics. The person must also be registered with the agency in accordance with §289.226(e) [ 42.22 of TRCR Part 42 as adopted by reference in §289.122 ] of this title and the Texas Radiation Control Act unless exempted by §289.226(b)(6) [ 42.2(f) of TRCR Part 42 as adopted by reference in §289.122 ] of this title. The person must participate in education programs, either by teaching or completing an average of at least five continuing medical education credits in mammography per year at intervals not to exceed three years.

(3)

Personnel responsibilities.

(A)

Supervising physician responsibilities shall include the following: [ are as follows: ]

(i)-(iv)

(No change.)

(v)

to select a technologist to perform the quality control tests; [ and ]

(vi)

to review the technologists' quality control test results at least every three months, or more frequently if consistency has not yet been achieved; and [ to review the physicists' results annually or more frequently when needed. ]

(vii)

to review the physicists' results annually or more frequently when needed.

(B)

Equipment operators' responsibilities shall include performing and recording the results of the following tests or tasks at the frequency indicated. The facility may assign the responsibility for individual tasks within the quality assurance program to a quality control technologist.

(i)-(xi)

(No change.)

(C)

Medical physicists' responsibilities include the following:

(i)

conducting an annual on-site mammography survey of the entire mammography system while the medical physicist is physically present, to include performance of the following:

(I)

alignment of beam limiting device in accordance with subsection (e)(1)(D) of this section;

(II)

evaluation of focal spot performance in accordance with subsection (e)(1)(E) of this section;

(III)

kVp accuracy in accordance with subsection (e)(1)(F) of this section;

(IV)

beam quality assessment (HVL measurement) in accordance with subsection (e)(1)(H) of this section;

(V)

AEC performance in accordance with subsection (e)(1)(G) of this section;

(VI)

uniformity of screen speed;

(VII)

average glandular dose in accordance with subsection (e)(2) of this section;

(VIII)

output reproducibility, mA and mAs linearity in accordance with subsection (e)(1)(N) of this section;

(IX)

image quality evaluation in accordance with subsection (e)(1)(L) of this section;

(X)

artifact evaluation; and

(ii)

performing a survey that verifies that the mammographic unit meets the equipment standards in subsection (e)(1) of this section and the average glandular dose meets the requirements of subsection (e)(2) of this section on equipment that is initially installed, replaced, or reassembled after moving; and

(iii)

verifying the average glandular dose within 60 days of replacement in accordance with subsection (e)(2) of this section on mammographic units that have had a tube or tube insert replaced.

(D)

The medical physicist shall provide the following to the facility:

(i)

a written report of the results of the tests listed in subparagraph (C) of this paragraph;

(ii)

written recommendations for corrective actions according to the test results; and

(iii)

a review of the test results with the supervising physician or his/her designee and the technologist(s) performing the quality control.

(E)

Records of the survey listed in subparagraph (C)(i) of this paragraph shall be maintained by the facility for seven years.

[ (C)

Medical physicists' responsibilities include an annual on-site mammography survey of the entire mammography system. Records of the survey shall be maintained by the facility for seven years. The survey by the medical physicist shall include:]

[ (i)

performing the tests listed below:]

[ (I)

alignment of beam limiting device in accordance with subsection (e)(1)(D) of this section;]

[ (II)

evaluation of focal spot performance in accordance with subsection (e)(1)(E) of this section;]

[ (III)

kVp accuracy in accordance with subsection (e)(1)(F) of this section;]

[ (IV)

beam quality assessment (HVL measurement) in accordance with subsection (e)(1)(H) of this section;]

[ (V)

AEC performance in accordance with subsection (e)(1)(G) of this section;]

[ (VI)

uniformity of screen speed;]

[ (VII)

average glandular dose in accordance with subsection (e)(2) of this section; and]

[ (VIII)

output reproducibility, mA and mAs linearity in accordance with subsection (e)(1)(N) of this section;]

[ (IX)

image quality evaluation in accordance with subsection (e)(1)(L) of this section; and]

[ (X)

artifact evaluation; and]

[ (ii)

providing the following to the facility:]

[ (I)

a written report of the test results;]

[ (II)

written recommendations for corrective actions according to the test results; and]

[ (III)

a review of the test results with the supervising physician or his/her designee and the technologist(s) performing the quality control.]

[ (D)

The medical physicists' responsibilities shall also include:]

[ (i)

performing a survey that verifies that the mammographic unit meets the equipment standards in subsection (e)(1) of this section and the average glandular dose meets the requirements of subsection (e)(2) of this section on equipment that is initially installed, replaced, or reassembled after moving; and]

[ (ii)

verifying the average glandular dose within 60 days of replacement in accordance with subsection (e)(2) of this section on mammographic units that have had a tube or tube insert replaced.]

(4)

Self-referral mammography. Any person proposing to conduct a self-referral mammography program shall not initiate such a program without prior approval of the agency. When requesting such approval, that person shall submit the following information:

(A)-(B)

(No change.)

(C)

written procedures to include methods of [ the following ]:

(i)

[ method of ] advising individuals of the results of the self-referral mammography procedure and any further medical needs indicated. If a report is sent to the mammography patient, it shall include a summary written in language easily understood by a lay person;

(ii)

[ method of ] advising private physicians of the results of the self-referral mammography procedure and any further medical needs indicated;

(iii)

[ method of ] follow-up to confirm that mammography patients with positive findings and mammography patients needing repeat exams[ , ] have received proper notification; and

(iv)

[ method of ] follow-up to confirm that practitioners have received proper notification of patients with positive findings needing repeat exams; and

(D)

(No change.)

(5)

Records required to be kept with units authorized for mobile services.

(A)

In addition to the requirements of §289.203(b) [ 22.11 of TRCR Part 22 as adopted by reference in §289.114 ] of this title, copies of the following shall be kept with units authorized for mobile services:

(i)-(iii)

(No change.)

(iv)

current [ TRCR Part 13 as adopted by reference in ] §289.112 of this title, §289.201 of this title, §289.202 of this title, §289.203 of this title, §289.226 of this title, and §289.230 of this title [ TRCR Part 21 as adopted by reference in §289.113 of this title, TRCR Part 22 as adopted by reference in §289.114 of this title, TRCR Part 42 as adopted by reference in §289.122 of this title, §289.201 of this title, and this section ].

(v)

copy of certification of mammography system; [ and ]

(vi)

certification of inspection or notice of failure from last inspection if applicable ; and [ . ]

(vii)

copy of mammography facility accreditation.

(B)

(No change.)

(6)

Records required at authorized use locations. Copies of the following shall be kept at authorized use locations:

[ (A)

In addition to the requirements of 22.11 of TRCR Part 22 as adopted by reference in §289.114 of this title, copies of the following shall be kept at authorized use locations:]

(A)

[ (i) ] operating and safety procedures in accordance with paragraph (7) of this subsection;

(B)

[ (ii) ] quality assurance program in accordance with paragraph (1) of this subsection;

(C)

[ (iii) ]credentials for interpreting physicians operating at that location in accordance with paragraph (2)(A) of this subsection;

(D)

[ (iv) ] credentials for medical radiologic technologists operating at that location in accordance with paragraph (2)(B) of this subsection;

(E)

[ (v) ] quality control records in accordance with paragraph (1) of this subsection;

(F)

[ (vi) ] training and continuing education records for interpreting physicians and medical radiologic technologists operating at that location in accordance with paragraph (2)(A) and (B) of this subsection;

(G)

[ (vii) ]current physicist annual survey of the mammography system;

(H)

[ (viii) ] current §289.112 of this title, §289.201 of this title, §289.202 of this title, §289.203 of this title, §289.204 of this title, §289.226 of this title, and §289.230 of this title; [ current TRCR divisions "General (G)" and "Registration (R)"; ]

(I)

[ (ix) ] copy of certification of mammography system;

(J)

[ (x) ] certification of inspection or notification of failure if applicable;

(K)

[ (xi) ] records of receipts, transfers, and disposal in accordance with paragraph (10) of this subsection; [ and ]

(L)

[ (xii) ] calibration, maintenance, and modification records in accordance with paragraph (13) [ (15) ] of this subsection ; and [ . ]

(M)

copy of mammography facility accreditation.

[ (B)

All records required by this section shall be maintained at a specific location for inspection by the agency.]

(7)

Operating and safety procedures. Each registrant shall have and implement written operating and safety procedures that shall be made available to each individual operating x-ray equipment, including any restrictions of the operating technique required for the safe operation of the particular x-ray system. These procedures shall include a quality assurance program in accordance with paragraph (1) of this subsection. These procedures may be included in a radiation protection program required by §289.202(e) [ 21.101 of TRCR Part 21 as adopted by reference in §289.113 ] of this title.

(8)

Occupational [ Radiation ] dose limitation and personnel monitoring. Except as otherwise exempted, all individuals who are associated with the operation of a radiation machine are subject to the occupational [ radiation ] dose requirements of §289.202 (f), (j), (l), and (m) [ §289.113 ] of this title regarding dose limits to individuals and the personnel monitoring requirements of §289.202(q) of this title.

(9)

Technique Chart. A chart or manual shall be provided or electronically displayed in the vicinity of the control [ central ] panel of each machine that [ which ] specifies technique factors to be utilized versus patient's anatomical size except for systems that have only automatic exposure control. The technique chart shall be used by all operators.

(10)-(13)

(No change.)

(e)

Mammographic x-ray systems.

(1)

Equipment standards. Only x-ray systems meeting the following standards shall be used:

(A)

System design. The [ Only ] equipment must have [ that has ] been specifically designed and manufactured for mammography in accordance with 21 Code of Federal Regulations (CFR) [ CFR ] 1010.2, 1020.30, and 1020.31 [ shall be used ].

(B)

(No change.)

(C)

Target/Filter. The x-ray system must have the capability of providing kVp/target/filter combinations compatible with image receptor systems meeting the requirements of subparagraph (B) of this paragraph [ paragraph (1)(B) of this subsection ].

(D)

(No change.)

(E)

Evaluation of focal spot performance: Focal spot performance shall be evaluated by measuring both parallel and perpendicular to the anode-cathode axis and determining whether they are in compliance with manufacturer-provided and National Electrical Manufacturers Association [ (NEMA) ] specifications. Focal spot performance also may be evaluated by determining limiting resolution by using a high-contrast resolution pattern. All focal spot dimensions shall be measured.

(F)

Accuracy of kVp. The actual kVp shall meet manufacturer's specifications or in the absence of manufacturer's specifications shall be within plus or minus 5.0% of the indicated kVp.

(G)

Automatic exposure control performance.

Figure: 25 TAC §289.230(e)(1)(G)

[ Figure: 25 TAC §289.230(e)(1)(G) ]

(H)

Beam quality. When used with screen-film image receptors, and the contribution to filtration made by the compression device is included, the HVL shall be greater than or equal to kVp/100 + 0.03 (in units of millimeters (mm) of aluminum (A1) but less than kVp/100 + C (mm of Al) [ (millimeters of aluminum) ] where C = 0.12 mm [ millimeters ] Al for molybdenum/molybdenum, C = 0.19 mm [ millimeters ] Al for molybdenum/rhodium, and C = 0.22 mm [ millimeters ] Al for rhodium/rhodium. Facilities with mammographic units with anode/filter combinations that do not meet the requirements of this paragraph may request an exemption. The exemption request should include manufacturer's specifications for HVL for the specific anode/filter combination. For xeroradiography, the HVL of the useful beam with the compression device in place shall be at least 1.0 and not greater than 1.6 mm [ millimeters ] aluminum equivalent, tested at the kVp used under clinical conditions.

(I)

(No change.)

(J)

Compression. The x-ray system shall be capable of compressing the breast with a force of at least 25 pounds and shall be capable of maintaining this compression for at least 15 seconds. For systems with automatic compression, the maximum force applied without manual assistance shall not exceed 40 pounds; and the chest wall edge of the compression paddle must be aligned with the chest wall edge of the image receptor to within plus or minus 1.0% of the SID with the compression paddle placed 6 cm [ centimeters ] above the patient support device.

(K)

Screen-film contact. Cassettes shall not be used for mammography if one or more large areas (greater than 1 square centimeter (cm2 ) ) of poor contact can be seen in a 40 mesh test.

(L)

Image quality.

(i)

The mammographic x-ray imaging system shall be capable of producing images of the mammographic phantom in which the following objects are visualized:

(I)

the four largest fibers with thicknesses of: 1.56 mm [ millimeters ], 1.12 mm [ millimeters ], 0.89 mm [ millimeters ], and 0.75 mm [ millimeters ].

(II)

the three largest speck groups with diameters of: 0.54 mm [ millimeters ], 0.40 mm [ millimeters ], and 0.32 mm [ millimeters ]; and

(III)

the three largest masses with thicknesses of: 2.0 mm [ millimeters ], 1.0 mm [ millimeters ], and 0.75 mm [ millimeters ];

(ii)

The optical density of the film should be greater than 1.20 with control limits of plus or minus 0.20; while the density difference should be [ about ] 0.40 with control limits of plus or minus 0.05 for a 4 mm [ millimeter- ] thick disc.

(iii)

(No change.)

(M)

Technique settings. The technique settings used for subparagraph (L) of this paragraph and paragraph (2) of this subsection shall be those used by the facility for its clinical images of a 50% adipose/50% glandular 4.0 to 4.5 cm [ centimeters ] compressed breast, utilizing the processor used for patient films.

(N)

Output reproducibility. Output reproducibility and ma or mAs linearity shall comply with the following:

(i)

Exposure reproducibility.

Figure: 25 TAC §289.230(e)(1)(N)(i)

[ Figure: 25 TAC §289.230(e)(1)(N)(i) ]

(ii)

Linearity.

Figure: 25 TAC §289.230(e)(1)(N)(ii)

[ Figure: 25 TAC §289.230(e)(1)(N)(ii) ]

(2)

Dose. The average glandular dose for one craniocaudal view of a 4.0 to 4.5 cm [ centimeters ] (1.8 inch) compressed breast, composed of 50% adipose/50% glandular tissue, shall not exceed the following values:

(A)

100 mrad [ millirads ] (1 (mGy) [ milligray ]) for film/screen systems without grid;

(B)

300 mrad [ millirads ] (3 (mGy) [ milligray ]) for film/screen systems with grid; and

(C)

400 mrad [ millirads ] (4 (mGy) [ milligray ]) for xeroradiographic systems.

(f)

Certification requirements. In addition to the requirements of §289.226(c) and if applicable, (g) [ 42.20 and 42.25 of TRCR Part 42 as adopted by reference in §289.122 ] of this title, [ if applicable, ] each applicant shall comply with the following.

(1)-(2)

(No change.)

(3)

An applicant for certification must obtain a certification on each mammography system that is used by the applicant or the applicant's agent (for the purposes of the requirements of this paragraph, the word "used" refers to the entity other than the technologist that directs the application of radiation to humans). An application for mammography system certification may contain information on multiple mammography x-ray units. Each x-ray unit must be identified by referring to the machine's manufacturer, model number, and serial number of the control panel. An applicant or applicant's agent shall provide proof of current accreditation by an accrediting body approved by the FDA on forms prescribed by the agency or submit an application for accreditation in accordance with subsection (p) of this section.

(4)

The applicant shall be qualified by reason of training and experience to use the mammographic machines for the purpose requested in accordance with this chapter [ these rules ] in such a manner as to minimize danger to public health and safety.

(5)

Each applicant shall submit documentation of the following:

(A)

(No change.)

(B)

personnel qualifications including dates of licensure or certification in accordance with subsection (d)(2) of this section;

(C)

model and serial number of each mammographic unit control panel; [ and ]

(D)

evidence of the following by a physicist holding a current Texas license under the Medical Physics Practice Act, Article 4512n with a specialty in Diagnostic Radiological Physics [ that ]:

(i)-(ii)

(No change.)

(E)

self-referral program information in accordance with subsection (d)(4) of this section, if the facility offers self-referral mammography [ , self-referral program information in accordance with subsection (d)(4) of this section ; ].

(6)

An applicant for certification of mammography stereotactic systems or other unique mammographic imaging modalities shall comply with subsections (d)(1)(A), (B)(xi)-(xiv), and (xvi); (d)(2)(B) and (C); (d)(3)(A)-(C), as applicable; (d)(5) and (6) as applicable; (d)(7)-(13); (e)(1)(E)-(H), and (N); (f) except for the accreditation requirements of FDA in (f)(3); (g)-(i) as applicable; (j)-(n); (o)(2)-(8); and (z)(1) and (2) of this section as applicable [ (d)(1)(A), (B)(xi)-(xiv), and (xvi); (2)(B) and (C); (3)(A) and (B) as applicable; (3)(C) as applicable; (6) as applicable; (7)-(13); (e)(1)(E)-(H), and (N); (f) except for the accreditation requirements of FDA in (f)(3); (g); (h); (i) as applicable; (j); (k); (l); (m); (n)(1)(B)-(G); (o)(1); and (2) as applicable, of this section ]. The purpose and scope of this section and the definitions in subsection (b) of this section also apply to certification of these systems.

(7)

(No change.)

(8)

Notwithstanding the provisions of §289.204 [ 12.11(a) of TRCR Part 12 as adopted by reference in §289.126 ] of this title, reimbursement of application fees may be granted in the following manner:

(A)-(B)

(No change.)

(C)

If the request for full reimbursement authorized by subparagraph (A) of this paragraph is denied, the applicant may then request a hearing by appeal to the Commissioner of Health for a resolution of the dispute. The appeal will be processed in accordance with Formal Hearing Procedures, §1.21-1.34 of this title (relating to the Texas Board of Health). [ the formal hearing procedures of the Texas Department of Health, §§1.21-1.34 of this title (relating to Formal Hearing Procedures). ]

(g)

Issuance of certification of mammography systems. Issuance of certification of mammography systems shall be in accordance with §289.226(k) [ 42.29 of TRCR Part 42 as adopted by reference in §289.122 ] of this title.

(h)

Specific terms and conditions of certification of mammography systems. Specific terms and conditions of certification of mammography systems shall be in accordance with §289.226(l) [ 42.31 of TRCR Part 42 as adopted by reference in §289.122 ] of this title.

(i)

Responsibilities of registrant.

(1)

In addition to the requirements of §289.226(m)(2) and (4)-(7) [ 42.32(b), (d), (e) and (f) of TRCR Part 42 as adopted by reference in §289.122 ] of this title, a registrant shall notify the agency in writing prior to any changes that would render the information contained in the application or the certification of mammography systems inaccurate. These include but are not limited to the following :

(A)-(B)

(No change.)

(C)

mammographic x-ray units.

[ (i)

A facility with an existing certification of mammography system may begin using a new or replacement unit before receiving an updated certification if the paperwork regarding the unit has been submitted to the agency with a licensed medical physicists's report verifying compliance of the new unit with the regulations. The physicist's report is required prior to using the unit on patients.]

[ (ii)

Loaner units may be used on patients for 60 days without adding the unit to the certification. A licensed medical physicist's report verifying compliance of the loaner unit with the regulations must be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use.]

[ (iii)

Units involved in clinical trial evaluations may be used on patients for 60 days without adding the unit to an existing certification. A licensed medical physicist's report verifying compliance of the loaner unit with the regulations must be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use. If the use period will exceed 60 days, the facility will be required to add the unit to their certification and a prorated fee will be assessed.]

[ (iv)

No fees will be assessed for loaner units or evaluation periods of 60 days or less.]

[ (v)

Loaner units or units involved in clinical trial evaluations are exempt from the inspection requirement in subsection (n)(1)(A) of this section.]

(2)

(No change.)

(3)

The following criteria applies to new, replacement, or loaner units and units used for clinical trial evaluations.

(A)

A facility with an existing certification of mammography system may begin using a new or replacement unit before receiving an updated certification if the paperwork regarding the unit has been submitted to the agency with a licensed medical physicists's report verifying compliance of the new unit with the regulations. The physicist's report is required prior to using the unit on patients.

(B)

Loaner units may be used on patients for 60 days without adding the unit to the certification. A licensed medical physicist's report verifying compliance of the loaner unit with the regulations must be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use.

(C)

Units involved in clinical trial evaluations may be used on patients for 60 days without adding the unit to an existing certification. A licensed medical physicist's report verifying compliance of the loaner unit with the regulations must be completed prior to use on patients. The results of the survey must be submitted to the agency with a cover letter indicating period of use. If the use period will exceed 60 days, the facility will be required to add the unit to their certification and a prorated fee will be assessed.

(D)

No fees will be assessed for loaner units or evaluation periods of 60 days or less.

(E)

Loaner units or units involved in clinical trial evaluations are exempt from the inspection requirement in subsection (o)(1) of this section.

(4)

[ (3) ] Records of training and experience and all other records required by this section shall be maintained for review in accordance with subsection (z)(2) [ (o)(2) ] of this section.

(j)

Expiration [ and termination ] of certification of mammography systems. [ Expiration and termination of certification of mammography systems shall be in accordance with 42.33 of TRCR Part 42 as adopted by reference in §289.122 of this title. ]

(1)

Except as provided by subsection (l) of this section, each certification of mammography systems expires at the end of the day in the month and year stated on the certificate of registration on the expiration date specified. Expiration of the certification of mammography systems does not relieve the registrant of the requirements of this chapter.

(2)

If a registrant does not submit an application for renewal of the certification of mammography systems under subsection (l) of this section, as applicable, the registrant shall on or before the expiration date specified in the certification of mammography systems:

(A)

terminate use of all radiation machines;

(B)

submit a record of the disposition of the x-ray units; and

(C)

pay any outstanding fees in accordance with §289.204 of this title.

(k)

Termination of certification of mammography systems. When a registrant decides to terminate all activities involving radiation machines authorized under the certification of mammography systems, the registrant shall:

(1)

notify the agency immediately;

(2)

request termination of the certification of mammography systems in writing;

(3)

submit a record of the disposition of the x-ray units; and

(4)

pay any outstanding fees in accordance with §289.204 of this title.

(l)

[ (k) ] Renewal of certification of mammography systems.

(1)

Application for renewal of certification shall be filed in accordance with this subsection [ (f) of this section ] and §289.226(c) and (g) [ 42.20 and 42.25 of TRCR Part 42 as adopted by reference in §289.122 ] of this title, as applicable.

(2)

If a registrant files an application in proper form at least 30 days before the existing certification expires, such existing certification shall not expire until the application status has been determined by the agency.

(3)

A certification for a mammographic unit is valid for three years from the date of issuance unless the certification of the facility is revoked prior to such deadlines [ one year and may be renewed annually on payment of the required fee ]. This is effective for certificates issued after September 1, 1997.

(A)

If a registrant fails to renew the certification by the required date, the registrant may renew the certification on payment of the annual [ renewal ] fee and a late fee. If the certification is not renewed before the 181st day after the date on which the certification [ certificate ] expired, the registrant must apply for an original certification under this section.

(B)

A mammography system may not be used after the expiration date of the certification unless the holder of the expired certification has made a timely and sufficient application for renewal of the certificate as provided in this subsection and §289.226(c) and (g) [ (j) of this section and 42.20 or 42.25 of TRCR Part 42 as adopted by reference in §289.122 ] of this title, as applicable.

(m)

[ (l) ] Modification and revocation of certification of mammography systems. Modification and revocation of certification of mammography systems shall be in accordance with §289.226(q) [ 42.35 of TRCR Part 42 as adopted by reference in §289.122 ] of this title.

(n)

[ (m) ] Reciprocal recognition of out-of-state certificates of registration. Mammographic x-ray units will not be granted reciprocal recognition and must comply with the requirements of [ subsection (e) of ] this section.

(o)

[ (n) ] Inspections. In addition to the requirements of §289.201(e) of this title, the following applies to inspections of mammography systems.

[ (1)

Routine inspection of mammography systems.]

(1)

[ (A) ] The agency shall inspect each mammography system that receives a certification in accordance with this chapter not later than the 60th day after the date the certification is issued.

(2)

[ (B) ] The agency shall inspect, at least once annually, each mammography system that receives a certification.

(3)

[ (C) ] To protect the public health, the agency may conduct more frequent inspections than required by this subsection [ section ].

(4)

[ (D) ] The agency shall make reasonable attempts to coordinate inspections in this chapter with other inspections required in accordance with this section for the facility where the mammography system is used.

(5)

[ (E) ] After each satisfactory inspection, the agency shall issue a certificate of inspection for each mammography system inspected. The certificate of inspection must be posted at a conspicuous place on or near the place where the mammography system is used. The certificate of inspection shall include the following :

(A)

[ (i) ] specific identification of [ specifically identify ] the mammography system inspected;

(B)

[ (ii) ] [ state ] the name and address of the facility where the mammography system was used at the time of the inspection; and

(C)

[ (iii) ][ state ] the date of the inspection.

(6)

[ (F) ] Any Severity Level I violation [ as described in 13.9 of TRCR Part 13 as adopted by reference in §289.112 of this title, ] found by the agency [ , ] constitutes grounds for posting notice of failure of the mammography system to satisfy agency requirements.

(A)

[ (i) ] Notification of such failure shall be posted:

(i)

[ (I) ] on the mammography x-ray unit at a conspicuous place if the violation is machine-related; or

(ii)

[ (II) ]near the place where the mammography system practices if the violation is personnel-related; and

(iii)

[ (III) ] in a sufficient number of places to permit the patient to observe the notice.

(B)

[ (ii) ] The notice of failure shall remain posted until the facility is authorized to remove it by the agency. A facility may post documentation of corrections of the violations submitted to the agency along with the notice of failure until approval to remove the notice of failure is received from the agency.

(7)

[ (G) ] The agency shall [ may ] require registrants to notify [ mammography ] patients on whom the facility performed a mammography during the 30 days preceding the date of the inspection that revealed the failure. [ whose health or safety may have been or may be adversely affected by failure of a mammography system to meet the requirements of the Act or this chapter. ] The facility shall:

(A)

inform the patient that the mammography system failed to satisfy the department's certification standards;

(B)

recommend that the patient have another mammogram performed at a facility with a certified mammography system; and

(C)

list the three facilities closest to the original testing facility that have a certified mammography system.

[ (i)

The patient notification, if required, shall include:]

[ (I)

explanation of the mammography system failure to the patient; and]

[ (II)

the potential consequences to the mammography patient.]

[ (ii)

The registrant shall maintain a record of the mammography patients notified in accordance with subsection (d)(1)(G) of this section for inspection by the agency. The records shall include the name and address of each mammography patient notified, date of notification, and a copy of the text sent to the individual.]

(8)

In addition to the requirements of paragraph (7) of this subsection, the agency may require a facility to notify a patient of any other failure of the facility's mammography system to meet the agency's certification standards.

(9)

The patient notification shall include the following:

(A)

explanation of the mammography system failure to the patient; and

(B)

the potential consequences to the mammography patient.

(10)

The registrant shall maintain a record of the mammography patients notified in accordance with paragraphs (7) and (8) of this subsection for inspection by the agency. The records shall include the name and address of each mammography patient notified, date of notification, and a copy of the text sent to the individual.

[ (2)

A mammography system that has been issued a certification under subsection (f)(3) of this section is exempt from the inspection requirements of paragraph (1)(A) of this subsection.]

(p)

Accreditation of mammography facilities.

(1)

All mammography facilities must be accredited by an authorized FDA accrediting body. All facilities applying for and receiving accreditation through the agency shall comply with §289.112 of this title, §289.201(c), (h)-(j), and (l)-(n) of this title, §289.203 of this title, subsections (b), (c)(1)-(3), (d)(1)-(3) and (7)-(13), and (e)(1) and (2) of this section.

(2)

In order to be accredited by the agency, the applicant shall submit an application for accreditation on forms and accompanying instructions prescribed by the agency.

(A)

Each application must be signed by a licensed physician.

(B)

The agency may at any time after the filing of the original application require further statements in order to enable the agency to determine whether the accreditation document should be issued, denied, modified, or revoked.

(C)

Applications and documents submitted to the agency may be made available for public inspection except that the agency may withhold any document or part thereof from public inspection in accordance with §289.201(n) of this title.

(D)

Each application for accreditation shall be accompanied by the fee prescribed in subsection (q) of this section.

(E)

Each applicant shall submit documentation of the following:

(i)

quality assurance program in accordance with subsection (d)(1) of this section;

(ii)

personnel qualifications, training, and experience in accordance with subsection (d)(2) of this section;

(iii)

model and serial number of each mammographic unit control panel;

(iv)

procedures on clinical image interpretation, patient notification, and patient data tracking; and

(v)

evidence of the following by a physicist holding a current Texas license under the Medical Physics Practice Act, Article 4512n with a specialty in Diagnostic Radiological Physics:

(I)

each unit meets the equipment standards in subsection (e)(1) of this section; and

(II)

the average glandular dose for one craniocaudal view for each unit does not exceed the appropriate values in subsection (e)(2) of this section.

(F)

Upon notification by the agency, each applicant shall directly submit the following to the American College of Radiology (ACR) in accordance with their procedures:

(i)

clinical images;

(ii)

phantom images; and

(iii)

processor data.

(q)

Fees for accreditation of mammography facilities.

(1)

Each application for accreditation of a mammography facility shall be accompanied by a nonrefundable fee. No application will be accepted for filing or processed prior to payment of the full amount specified.

(2)

A nonrefundable fee in accordance with paragraph (4) of this subsection shall be paid every three years for each accredited mammography unit. The fee shall be paid in full on or before the expiration date of the accreditation document if the facility wishes to remain accredited with the agency.

(3)

Fee payments shall be in cash or by check or money order made payable to the Texas Department of Health. The payments may be made by personal delivery to the Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas, or mailed to the Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3189.

(4)

Fees for accreditation of mammography facilities are as follows.

(A)

The accreditation fee for the first mammography unit is $720.

(B)

The accreditation fee for each additional mammography unit is $345.

(C)

The fee for reevaluation of clinical images is $220 per unit.

(r)

Issuance of accreditation of a mammography facility. An accreditation document will be issued when the mammography facility meets the requirements of subsection (p) of this section and becomes accredited by the agency. In order for an accreditation to be issued, the agency must be notified by the ACR that the applicant met criteria for clinical images, phantom images, and processor quality control.

(s)

Specific terms and conditions of accreditation of mammography facilities.

(1)

Each accreditation document issued in accordance with this section shall be subject to the applicable provisions of the Act, now or hereafter in effect, and to the applicable requirements and orders of the agency.

(2)

No accreditation document issued by the agency under this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person.

(t)

Responsibilities of an accredited facility. A facility shall notify the agency at least annually of any changes that would render the information contained in the application inaccurate.

(u)

Expiration and renewal of accreditation of mammography facilities.

(1)

The accreditation shall expire on the date specified on the accreditation document.

(2)

Application for renewal of accreditation shall be filed in accordance with subsection (p) of this section and subsection (q) of this section.

(3)

If a registrant files an application in proper form at least 30 days before the existing accreditation expires, such existing accreditation shall not expire until the application status has been determined by the agency.

(4)

Accreditation for a mammographic facility is valid for three years from the date of issuance, unless accreditation of the facility is revoked prior to such deadline.

(5)

Issuance of renewal of accreditation shall be in accordance with subsection (r) of this section.

(v)

Denial of accreditation of mammography facilities.

(1)

Any application for accreditation may be denied by the agency when the applicant fails to meet established criterion for accreditation or fails to respond to requests for information. Agency action on an application will be abandoned due to lack of response by the applicant. Abandonment of such actions does not provide an opportunity for a hearing; however, the applicant retains the right to resubmit the application at any time.

(2)

Before the agency denies an application for accreditation, the agency shall give notice by personal service or by certified mail, return receipt requested, of the intent to deny, the facts warranting the denial, and afford the applicant an opportunity for a hearing. If no request for a hearing is received by the director of the Radiation Control Program within 30 days of personal service or the date of mailing, the agency may proceed to deny. The applicant shall have the burden of proof showing cause why the application should not be denied.

(w)

Modification and revocation of accreditation of mammography facilities.

(1)

Any accreditation document may be revoked, suspended, or modified, in whole or in part, for any of the following:

(A)

any material false statement in the application or any statement of fact required under provisions of the Act;

(B)

conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant an accreditation document on an original application; or

(C)

violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the accreditation document, or order of the agency.

(2)

Except in cases of willfulness or those in which the public health, interest or safety requires otherwise, no accreditation document shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate or achieve compliance with all lawful requirements.

(x)

On-site facility visit. Each accredited facility shall:

(1)

afford the agency, at all reasonable times, opportunity to audit the facility where mammography equipment or associated equipment is used or stored; and

(2)

make available to the agency for inspection, upon reasonable notice, records maintained in accordance with this chapter.

(y)

Complaints. Each facility shall publish the following address where complaints may be filed with the Mammography Accreditation Program of the Bureau of Radiation Control: Texas Department of Health, Bureau of Radiation Control, Mammography Accreditation Program, 1100 West 49th Street, Austin, Texas 78756-3189.

(z)

[ (o) ] Appendices.

(1)

Subjects to be included in mammography training shall be as follows:

(A)

anatomy and physiology of the female breast that [ which ] shall include:

(i)

mammary glands;

(ii)

external anatomy;

(iii)

retromammary space;

(iv)

central portion;

(v)

cooper's ligament;

(vi)

vessels, nerves, lymphatics; and

(vii)

breast tissue:

(I)

fibro-glandular;

(II)

fibro-fatty;

(III)

fatty; and

(IV)

lactating; [ and ]

(B)

mammography positioning that [ which ] shall include actual positioning of patients and/or models as follows:

(i)

craniocaudal;

(ii)

mediolateral oblique;

(iii)

supplemental;

(iv)

magnification;

(v)

errors in positioning;

(vi)

postoperative breast and the augmented breast;

(vii)

breast localization and specimen radiography; and

(viii)

use of compression;

(C)

technical factors;

(D)

film evaluation and critique;

(E)

pathology; and

(F)

quality assurance program.

(2)

Time requirements for record keeping shall be in accordance with the following chart.

Figure: 25 TAC §289.230(z)(2)

[ Figure: 25 TAC §289.230(o)(2) ]

This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.

Filed with the Office of the Secretary of State on April 20, 1998.

TRD-9805506

Susan K. Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: May 31, 1998

For further information, please call: (512) 458-7236