Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 289.
RADIATION CONTROL
Subchapter E. REGISTRATION REGULATIONS
25 TAC §289.232
The Texas Department of Health (department) proposes new §289.232,
concerning radiation control regulations for dentists using radiation machines.
The new section consolidates requirements that are applicable only to dentists
using radiation machines from the current requirements in §289.201 of
this title (relating to General Provisions for Radioactive Material), §289.202
of this title (relating to Standards for Protection Against Radiation from
Radioactive Material), §289.203 of this title (relating to Notices, Instructions,
and Reports to Workers; Inspections), §289.204 of this title (relating
to Fees for Certificates of Registration, Radioactive Material(s) Licenses,
Emergency Planning and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.226
of this title (relating to Registration of Radiation Machine Use and Services),
and §289.227 of this title (relating to Use of Radiation Machines in
the Healing Arts and Veterinary Medicine). The requirements for radioactive
materials and other types of radiation machines found in those sections are
much lengthier and more complex. Therefore, separating and consolidating the
requirements applicable only to dental radiation machines, provide for a more
efficient rule and less burden on the dentists required to comply with these
requirements.
In addition to consolidation of requirements, the new section includes
clarification of several definitions. The fee for dental facilities that possess
10 or more radiation machines is increased to correct an error in the amount
as compared to the fee for dental facilities possessing one to nine radiation
machines. Language is added to clarify that persons who receive, possess,
use, or acquire radiation machines prior to receiving a certificate of registration
are also subject to the requirements in this chapter. The language that allows
the department to make exemptions to the requirements of this chapter is revised
to reflect changes made as a result of House Bill 1172 passed by the 76th
Legislature. Language that specifies the department may enter public or private
property to determine compliance with department rules and orders is added.
The method by which inspections are performed is modified based upon a review
of how dental radiation machines are regulated, compliance history, and the
health and safety risk associated with the use of such machines. The condition
requiring monitoring of radiation exposures to minors is modified. The condition
requiring monitoring of radiation exposures to a declared pregnant woman is
modified and clarified to state that the dose limit requiring monitoring for
a declared pregnant woman is applicable only for the nine-month gestation
period. Other minor grammatical changes are made to the section for clarification.
This section is part of the department's continuing effort to update, clarify,
and simplify its rules regarding the control of radiation based upon technological
changes, public concerns, legislative directives, or other factors.
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 years the section is in effect, there will be fiscal implications
to state or local government as a result of enforcing or administering the
section as proposed. The fiscal impact to state or local government entities
that possess 10 or more radiation machines at a dental facility will be an
annual increase of $50 in the certificate of registration fees. An additional
cost ranging from $0 to $25 will be incurred every four years to test the
radiographic entrance exposure from the machine(s). The department will receive
approximately $9,310 in additional revenue for each year of the first five-year
period. The increased revenue will recover costs of regulating entities that
possess 10 or more radiation machines.
Mrs. McBurney has also determined that for each year of the first five
years the section is in effect, the public benefit anticipated as a result
of enforcing or administering the section will be to ensure continued protection
of the public and workers from unnecessary exposure to machine-produced radiation.
The effect on small businesses and micro-businesses and persons required to
comply with the section as proposed will vary depending on the number of dental
radiation machines authorized on a certificate of registration. In addition,
a cost ranging from $0 to $25 will be incurred every four years to test the
radiographic entrance exposure from the machine(s). There is no anticipated
impact on local employment.
Comments on the proposal may be submitted 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, (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 meeting to accept oral comments will be held at 9:00 a.m., Tuesday,
May 9, 2000, in Conference Room N218, Texas Department of Health, Bureau of
Radiation Control, located at the Exchange Building, 8407 Wall Street, Austin,
Texas.
The new section 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 provides the board with the authority to adopt rules for its procedure
and for the performance of every duty imposed by law on the board, the department,
and the commissioner of health.
The proposed new section affects Health and Safety Code, Chapter 401 and
Chapter 12.
§289.232. Radiation Control Regulations for Dentists Using Radiation Machines.
(a)
Purpose. This section establishes the following.
(1)
Fees for certificates of registration for dental facilities
and provisions for their payment.
(2)
Requirements for the registration of persons using
radiation machines. No person shall use radiation machines except as authorized
in a certificate of registration issued by the agency in accordance with the
requirements of this section. A person who receives, possesses, uses, owns,
or acquires radiation machines prior to receiving a certificate of registration
is subject to the requirements of this chapter.
(3)
Requirements designed to control the receipt, possession,
use, and transfer of radiation machines by any person so the total dose to
an individual, including doses resulting from all sources of radiation other
than background radiation, does not exceed the standards for protection against
radiation prescribed in this section. However, nothing in this section shall
be construed as limiting actions that may be necessary to protect health and
safety in an emergency.
(4)
Requirements for the use of radiation machines in
dentistry. All usage of such machines under this section shall be made by
or under the supervision of a dentist. The registrant shall assure that the
requirements of this section are met in the operation of such radiation machines.
(5)
Specific record keeping requirements and general
provisions for records and reports.
(6)
Requirements for providing notices to employees and
instructions and options available to such individuals in connection with
agency inspections of registrants to ascertain compliance with the provisions
of the Texas Radiation Control Act and rules, orders, and certificates of
registration issued thereunder regarding radiological working conditions.
(7)
Governing of the following in accordance with the
Texas Radiation Control Act, the Texas Administrative Procedure Act, Texas
Government Code, Chapter 2001, and the Formal Hearing Procedures, Chapter
1, §§1.21 - 1.34 of this title (relating to the Texas Board of Health):
(A)
proceedings for the granting, denying, renewing, transferring,
amending, suspending, revoking, or annulling of a certificate of registration;
(B)
determining compliance with or granting of exemptions
from agency rule, order, or condition of certificate of registration;
(C)
assessing administrative penalties; and
(D)
determining propriety of other agency orders.
(b)
Scope.
(1)
Except as specifically provided in other sections of this
chapter, this section applies to persons who receive, possess, use, or transfer
dental radiation machines. The dose limits in this section do not apply to
doses due to background radiation, to exposure of patients to radiation for
the purpose of dental diagnosis, to exposure from individuals administered
radioactive material and released in accordance with this chapter, or to voluntary
participation in medical research programs. However, no radiation may be deliberately
applied to human beings except by or under the supervision of an individual
licensed by the Texas State Board of Dental Examiners, with license in good
standing.
(2)
Persons who are also registered by the agency to
receive, possess, acquire, transfer, or use class IIIb and class IV lasers
in dentistry must also comply with the requirements of §289.301 of this
title (relating to Registration and Radiation Safety Requirements for Lasers).
(3)
Except as otherwise specifically provided, the requirements
in this section apply to any applicant for, or holder of a certificate of
registration for dental radiation machines issued in accordance with subsection
(h) of this section.
(4)
The agency may, by rule, order, or condition of certificate
of registration, impose upon any registrant such requirements in addition
to those established in this chapter as it deems appropriate or necessary
to minimize danger to public health and safety or property or the environment.
(c)
Definitions. The following words and terms when used in
this section shall have the following meaning, unless the context clearly
indicates otherwise.
(1)
Absorbed dose - The energy imparted by ionizing radiation
per unit mass of irradiated material. The units of absorbed dose are the gray
(Gy) and the rad.
(2)
Accessible surface - The external surface of the
enclosure or housing provided by the manufacturer.
(3)
Administrative law judge (ALJ) - A judge employed
by the State Office of Administrative Hearings.
(4)
Administrative penalty - A monetary penalty assessed
by the agency in accordance with the Texas Radiation Control Act, §401.384,
to emphasize the need for lasting remedial action and to deter future violations.
(5)
Adult - An individual 18 or more years of age.
(6)
Agency - The Texas Department of Health.
(7)
Agreement State - Any state with which the United
States Nuclear Regulatory Commission has entered into an effective agreement
under the Atomic Energy Act of 1954 (42 United States Code et seq.), as amended.
(8)
As low as is reasonably achievable - Making every
reasonable effort to maintain exposures to radiation as far below the dose
limits in this section as is practical, consistent with the purpose for which
the registered activity is undertaken, taking into account the state of technology,
the economics of improvements in relation to the state of technology, the
economics of improvements in relation to benefits to the public health and
safety, and other societal and socioeconomic considerations, and in relation
to utilization of ionizing radiation and registered radiation machines in
the public interest.
(9)
Automatic exposure control - A device that automatically
controls one or more technique factors in order to obtain a required quantity
of radiation at preselected locations (See definition for phototimer).
(10)
Background radiation - Radiation from cosmic sources;
non-technologically enhanced naturally occurring radioactive material, including
radon, except as a decay product of source or special nuclear material; and
including global fallout as it exists in the environment from the testing
of nuclear explosive devices or from past nuclear accidents such as Chernobyl
that contribute to background radiation and are not under the control of the
registrant. "Background radiation" does not include radiation from sources
of radiation regulated by the agency.
(11)
Barrier (See definition for protective barrier).
(12)
Beam-limiting device - A device that provides a
means to restrict the dimensions of the x-ray field.
(13)
Beam quality (diagnostic x-ray) - A term that describes
the penetrating power of the x-ray beam. This is identified numerically by
half-value layer and is influenced by kVp and filtration.
(14)
Board - The Texas Board of Health.
(15)
Calibration - As pertaining to radiation detection
instruments, the comparative response or reading of an instrument relative
to a series of known radiation values over the range of the instrument.
(16)
Certificate of registration - A form of permission
given by the agency to an applicant who has met the requirements for registration
set out in the Texas Radiation Control Act and this section.
(17)
Certified equipment - Equipment that has been certified
in accordance with Title 21, Code of Federal Regulations.
(18)
Coefficient of variation or C - The ratio of the
standard deviation to the mean value of a population of observations. It is
estimated using the following equation:
Figure: 25 TAC §289.232(c)(18)
(19)
Collective dose - The sum of the individual doses
received in a given period of time by a specified population from exposure
to a specified source of radiation.
(20)
Contested case - A proceeding in which the agency
determines the legal rights, duties, or privileges of a party after an opportunity
for adjudicative hearing.
(21)
Continuous pressure type switch - A switch so constructed
that a circuit closing contact can be maintained only by continuous pressure
on the switch by the operator.
(22)
Control panel - The 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.
(23)
Declared pregnant woman - A woman who has voluntarily
informed the registrant, in writing, of her pregnancy and the estimated date
of conception. The declaration remains in effect until the declared pregnant
woman voluntarily withdraws the declaration in writing or is no longer pregnant.
(24)
Deep dose equivalent, that applies to external whole
body exposure - The dose equivalent at a tissue depth of 1 centimeter (1000
milligrams per square centimeter)).
(25)
Dentist - An individual licensed by the Texas State
Board of Dental Examiners, with license in good standing.
(26)
Diagnostic source assembly - The tube housing assembly
with a beam-limiting device attached.
(27)
Dose - For external exposure to x-ray radiation
from radiation machines, a generic term that means absorbed dose, dose equivalent,
or total effective dose equivalent. For purposes of this section, "radiation
dose" is an equivalent term.
(28)
Dose equivalent - The product of the absorbed dose
in tissue, quality factor, and all other necessary modifying factors at the
location of interest. The units of dose equivalent are the sievert and rem.
(29)
Dose limits - The permissible upper bounds of radiation
doses established in accordance with this section. For purposes of this section,
"limits" is an equivalent term.
(30)
Embryo/fetus - The developing human organism from
conception until the time of birth.
(31)
Enforcement conference - A meeting held by the agency
with management of a registrant to discuss the following:
(A)
safety or safeguards;
(B)
compliance with regulatory registration condition requirements;
(C)
proposed corrective measures including, but not limited
to, schedules for implementation; and
(D)
enforcement options available to the agency.
(32)
Entrance exposure - The exposure expressed
in roentgens (R), measured in air with the specified technique, calculated
or adjusted to represent the exposure at the point where the center of the
useful beam enters the patient.
(33)
Exposure - The quotient of dQ by dm where "dQ" is
the absolute value of the total charge of the ions of one sign produced in
air when all the electrons (negatrons and positrons) liberated by photons
in a volume element of air having mass "dm" are completely stopped in air.
The SI unit of exposure is the coulomb per kilogram. For purposes of this
section, this term is used as a noun.
(34)
Exposure rate - The exposure per unit of time.
(35)
External dose - That portion of the dose equivalent
received from any source of radiation outside the body.
(36)
Extremity - Hand, elbow, arm below the elbow, foot,
knee, and leg below the knee. The arm above the elbow and the leg above the
knee are considered part of the whole body.
(37)
Field emission equipment - Equipment that uses an
x-ray tube in which electron emission from the cathode is due solely to the
action of an electric field.
(38)
Filter - Material placed in the useful beam to preferentially
absorb selected radiations.
(39)
Gray - The SI unit of absorbed dose. One gray is
equal to an absorbed dose of 1 joule per kilogram or 100 rad.
(40)
Half-value layer - 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.
(41)
Healing arts - Any system, treatment, operation,
diagnosis, prescription, or practice for the ascertainment, cure, relief,
palliation, adjustment, or correction of any human disease, ailment, deformity,
injury, or unhealthy or abnormal physical or mental condition.
(42)
Hearing - A proceeding to examine an application
or other matter before the agency in order to adjudicate rights, duties, or
privileges.
(43)
Human use - For exposure to x-ray radiation from
radiation machines, the external administration of radiation to human beings
for healing arts purposes or research and/or development specifically authorized
by the agency.
(44)
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.
(45)
Individual - Any human being.
(46)
Individual monitoring - The assessment of dose equivalent
to an individual by the use of:
(A)
individual monitoring devices; or
(B)
survey data.
(47)
Individual monitoring devices - Devices designed
to be worn by a single individual for the assessment of dose equivalent. For
purposes of this section, "personnel dosimeter" and "dosimeter" are equivalent
terms. Examples of individual monitoring devices are film badges, thermoluminescence
dosimeters, optically stimulated luminescence dosimeters, pocket ionization
chambers (pocket dosimeters), and electronic personal dosimeters.
(48)
Inspection - An official examination and/or observation
including, but not limited to, records, tests, surveys, and monitoring to
determine compliance with the Texas Radiation Control Act and agency rules,
orders, requirements, and conditions of the certificate of registration.
(49)
Institutional Review Board - Any board, committee,
or other group formally designated by an institution to review, approve the
initiation of, and conduct periodic review of biomedical research involving
human subjects.
(50)
Interested person - A person who participates in
a hearing concerning a contested case but who is not admitted as a party by
the ALJ.
(51)
Ionizing radiation - Any electromagnetic or particulate
radiation capable of producing ions, directly or indirectly, in its passage
through matter. Ionizing radiation includes gamma rays and x rays, alpha and
beta particles, high speed electrons, neutrons, and other nuclear particles.
(52)
kV - Kilovolt.
(53)
kVp - Kilovolt peak (See definition for peak tube
potential).
(54)
kWs - Kilowatt-second. It is equivalent to 10 E
3 watt-second, where 1 watt-second =1 kilovolt x 1 milliampere x 1 second.
(55)
Lead equivalent - The thickness of lead affording
the same attenuation, under specified conditions, as the material in question.
(56)
Leakage radiation - Radiation emanating from the
diagnostic assembly except for the useful beam and radiation produced.
(57)
Lens dose equivalent - The external dose equivalent
to the lens of the eye at a tissue depth of 0.3 centimeters (300 milligrams
per square centimeter).
(58)
License - A form of permission given by the agency
to an applicant who has met the requirements for licensing set out in the
Texas Radiation Control Act and this chapter.
(59)
Licensed material - Radioactive material received,
possessed, used, or transferred under a general or specific license issued
by the agency.
(60)
Licensed medical physicist - An individual holding
a current Texas license under the Medical Physics Practice Act, Texas Civil
Statutes, Article 4512n.
(61)
Licensee - Any person who is licensed by the agency
in accordance with the Texas Radiation Control Act and this chapter.
(62)
Licensing state - Any state with rules equivalent
to the Suggested State Regulations for Control of Radiation relating to, and
having an effective program for, the regulatory control of naturally occurring
or accelerator-produced radioactive material (NARM) and has been designated
as such by the Conference of Radiation Control Program Directors, Inc.
(63)
mA - Milliampere.
(64)
mAs - Milliampere-second.
(65)
Medical research - The investigation of various
health risks and diseases using radiation machines as part of the evaluation
process.
(66)
Member of the public - Any individual, except when
that individual is receiving an occupational dose.
(67)
Minor - An individual less than 18 years of age.
(68)
Mobile services - The utilization of radiation machines
in temporary locations for limited time periods. The radiation machines may
be fixed inside a mobile van or transported to temporary locations.
(69)
Mobile x-ray equipment - (See definition for x-ray
equipment).
(70)
Monitoring - The measurement of radiation and the
use of the results of these measurements to evaluate potential exposures and
doses. For purposes of this chapter, "radiation monitoring" and "radiation
protection monitoring" are equivalent terms.
(71)
Non-certified equipment - Equipment manufactured
and assembled prior to certification requirements of 21 Code of Federal Regulations.
(72)
Notice of violation - A written statement of one
or more alleged infringements of a legally binding requirement. The notice
normally requires the registrant to provide a written statement describing
the following:
(A)
corrective steps taken by the registrant and the results
achieved;
(B)
corrective steps to be taken to prevent recurrence; and
(C)
the projected date for achieving full compliance. The
agency may require responses to notices of violation to be under oath.
(73)
Occupational dose - The dose received by an
individual in the course of employment in which the individual's assigned
duties involve exposure to radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. Occupational dose does not include dose received from background
radiation, from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released in
accordance with this chapter or from voluntary participation in medical research
programs, or as a member of the public.
(74)
Order - A specific directive contained in a legal
document issued by the agency.
(75)
Party - A person designated as such by the ALJ.
A party may consist of the following:
(A)
the agency;
(B)
an applicant, licensee, registrant, accredited mammography
facility, or certified industrial radiographer; and
(C)
any person affected.
(76)
Patient - An individual subjected to dental
examination, diagnosis, or treatment.
(77)
Peak tube potential - The maximum value of the potential
difference across the x-ray tube during an exposure.
(78)
Person - Any individual, corporation, partnership,
firm, association, trust, estate, public or private institution, group, agency,
local government, any other state or political subdivision or agency thereof,
or any other legal entity, and any legal successor, representative, agent,
or agency of the foregoing, other than the United States Nuclear Regulatory
Commission, and other than federal government agencies licensed or exempted
by the United States Nuclear Regulatory Commission.
(79)
Personnel monitoring equipment (See definition for
individual monitoring devices.)
(80)
Phototimer - A method for controlling radiation
exposures to image receptors by the amount of radiation that reaches a radiation
monitoring device. The radiation monitoring device is part of an electronic
circuit that controls the duration of time the tube is activated (See definition
for automatic exposure control).
(81)
Portable x-ray equipment - (See definition for x-ray
equipment).
(82)
Primary protective barrier - (See definition for
protective barrier).
(83)
Protective barrier - A barrier of radiation absorbing
materials used to reduce radiation exposure. The types of protective barriers
are as follows:
(A)
primary protective barrier - The material, excluding filters,
placed in the useful beam, for protection purposes, to reduce the radiation
exposure.
(B)
secondary protective barrier - A barrier sufficient to
attenuate the stray radiation to the required degree.
(84)
Public dose - The dose received by a member
of the public from exposure to radiation from licensed/registered and unlicensed/unregistered
sources of radiation, whether in the possession of the licensee/registrant
or other person. It does not include occupational dose or doses received from
background radiation, from any medical administration the individual has received,
from exposure to individuals administered radioactive material and released
in accordance this chapter or from voluntary participation in medical research
programs, or as a member of the public.
(85)
Rad - The special unit of absorbed dose. One rad
is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram
(0.01 gray).
(86)
Radiation - One or more of the following:
(A)
gamma and x rays; alpha and beta particles and other atomic
or nuclear particles or rays;
(B)
stimulated emission of radiation from any electronic device
to such energy density levels as to reasonably cause bodily harm; or
(C)
sonic, ultrasonic, or infrasonic waves from any electronic
device or resulting from the operation of an electronic circuit in an electronic
device in the energy range to reasonably cause detectable bodily harm.
(87)
Radiation area - Any area, accessible to individuals,
in which radiation levels could result in an individual receiving a dose equivalent
in excess of 0.005 rem (0.05 millisievert) in one hour at 30 centimeters from
the radiation machine or from any surface that the radiation penetrates.
(88)
Radiation machine - Any device capable of producing
ionizing radiation except those devices with radioactive material as the only
source of radiation.
(89)
Radiation safety officer - An individual who has
a knowledge of and the authority and responsibility to apply appropriate radiation
protection rules, standards, and practices, who must be specifically authorized
on a certificate of registration, and who is the primary contact with the
agency.
(90)
Radiograph - An image receptor on which the image
is created directly or indirectly by an x-ray pattern and results in a permanent
record.
(91)
Registrant - Any person issued a certificate of
registration by the agency in accordance with the Texas Radiation Control
Act and this chapter.
(92)
Regulation (See definition for rule.)
(93)
Rem - The special unit of any of the quantities
expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed
dose in rad multiplied by the quality factor (1 rem = 0.01 sievert).
(94)
Remote inspection - An examination by the agency
of information submitted by the registrant on a form provided by the agency.
(95)
Requestor - A person claiming party status as a
person affected.
(96)
Research and development - Research and development
is defined as:
(A)
theoretical analysis, exploration, or experimentation;
or
(B)
the extension of investigative findings and theories of
a scientific or technical nature into practical application for experimental
and demonstration purposes, including the experimental production and testing
of models, devices, equipment, materials, and processes.
(97)
Restricted area - An area, access to which
is limited by the registrant for the purpose of protecting individuals against
undue risks from exposure to radiation. Restricted area does not include areas
used as residential quarters, but separate rooms in a residential building
may be set apart as a restricted area.
(98)
Roentgen (R) - The special unit of exposure. One
roentgen (R) equals 2.58 x 10
-4
coulombs per
kilogram of air. (See definition for exposure.)
(99)
Rule - Any agency statement of general applicability
that implements, interprets, or prescribes law or policy, or describes the
procedure or practice requirements of an agency. The term includes the amendment
or repeal of a prior section but does not include statements concerning only
the internal management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as "regulation."
(100)
Scattered radiation - Radiation that has been deviated
in direction during passage through matter.
(101)
Secondary protective barrier (See definition for
protective barrier).
(102)
Severity level - A classification of violations
based on relative seriousness of each violation and the significance of the
effect of the violation on the occupational or public health or safety.
(103)
Shallow dose equivalent - The dose equivalent at
a tissue depth of 0.007 centimeters (7 milligrams per square centimeter) averaged
over an area of 1 square centimeter (applies to the external exposure of the
skin or an extremity).
(104)
SI - The abbreviation for the International System
of Units.
(105)
Sievert - The SI unit of any of the quantities
expressed as dose equivalent. The dose equivalent in sievert is equal to the
absorbed dose in gray multiplied by the quality factor (1 sievert = 100 rem).
(106)
Source of radiation - Any radioactive material,
or any device or equipment emitting or capable of producing radiation.
(107)
Source-to-image receptor distance - The distance
from the source to the center of the input surface of the image receptor.
(108)
Source-to-skin distance - The distance between
the source and the skin of the patient.
(109)
Special units - The conventional units historically
used by registrants, i.e., rad (absorbed dose), and rem (dose equivalent).
(110)
Stationary x-ray equipment - (See definition for
x-ray equipment).
(111)
Stray radiation - The sum of leakage and scattered
radiation.
(112)
Supervision - The delegating of the task of applying
radiation in accordance with this section to persons not licensed in dentistry,
who provide services under the dentist's control. The dentist assumes full
responsibility for these tasks and must assure that the tasks will be administered
correctly.
(113)
Survey - An evaluation of the radiological conditions
and potential hazards incident to the production, use, transfer, and/or disposal
of radiation machines. When appropriate, such survey includes, but is not
limited to, tests, physical examination of location of equipment or radiation
machines, and measurements of levels of radiation present, and evaluation
of administrative and/or engineered controls.
(114)
Technique chart - A chart that provides all necessary
generator control settings and geometry needed to make clinical radiographs
when the radiation machine is in manual mode.
(115)
Technique factors - The conditions of operation
that are specified as follows:
(A)
for capacitor energy storage equipment, peak tube potential
in kilovolt and quantity of charge in milliampere-second;
(B)
for field emission equipment rated for pulsed operation,
peak tube potential in kilovolt and number of x-ray pulses; and
(C)
for all other equipment, peak tube potential in kilovolt
and either tube current in milliamperes and exposure time in seconds or the
product of tube current and exposure time in milliampere-second.
(116)
Termination - A release by the agency of the
obligations and authorizations of the registrant under the terms of the certificate
of registration. It does not relieve a person of duties and responsibilities
imposed by law or rule.
(117)
Texas Regulations for Control of Radiation (TRCR)
- All sections of Title 25 Texas Administrative Code, Chapter 289.
(118)
Total effective dose equivalent - For external
exposures only to x-ray radiation from radiation machines, the total effective
dose equivalent is equal to the deep dose equivalent. If an individual receives
an occupational dose from both radiation machines and radioactive materials,
the total effective dose equivalent is the sum of the deep dose equivalent
for external exposures and the committed effective dose equivalent for internal
exposures as defined in §289.201(b) of this title.
(119)
Tube - An x-ray tube, unless otherwise specified.
(120)
Tube housing assembly - The tube housing with tube
installed. It includes high-voltage and/or filament transformers and other
appropriate elements when such are contained within the tube housing.
(121)
Unrestricted area (uncontrolled area) - An area,
access to which is neither limited nor controlled by the registrant. For purposes
of this section, "uncontrolled area" is an equivalent term.
(122)
Useful beam - The radiation emanating from the
tube housing port or the radiation head and passing through the aperture of
the beam-limiting device when the exposure controls are in a mode to cause
the system to produce radiation.
(123)
Violation - An infringement of any rule, license
or registration condition, order of the agency, or any provision of the Texas
Radiation Control Act.
(124)
X-ray control - A device that controls input power
to the x-ray high-voltage generator and/or the x-ray tube. It includes components
such as timers, phototimers, automatic brightness stabilizers, and similar
devices that control the technique factors of an x-ray exposure.
(125)
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)
portable x-ray equipment - x-ray equipment designed to
be hand-carried; or
(C)
stationary x-ray equipment - x-ray equipment that is installed
in a fixed location.
(126)
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.
(127)
X-ray high-voltage generator - A device that transforms
electrical energy from the potential supplied by the x-ray control to the
tube operating potential. The device may also include means for transforming
alternating current to direct current, filament transformers for the x-ray
tubes, high-voltage switches, electrical protective devices, and other appropriate
elements.
(128)
X-ray system - An assemblage of components for
the controlled production of x rays. It includes minimally an x-ray high-voltage
generator, an x-ray control, a tube housing assembly, a beam-limiting device,
and the necessary supporting structures. Additional components that function
with the system are considered integral parts of the system.
(129)
X-ray subsystem - Any combination of two or more
components of an x-ray system.
(130)
X-ray tube - Any electron tube that is designed
to be used primarily for the production of x rays.
(131)
Whole body - For purposes of external exposure,
head, trunk including male gonads, arms above the elbow, or legs above the
knee.
(132)
Worker - An individual engaged in work under a
certificate of registration issued by the agency and controlled by a registrant,
but does not include the registrant.
(133)
Year - The period of time beginning in January
used to determine compliance with the provisions of this chapter. The registrant
may change the starting date of the year used to determine compliance by the
registrant provided that the change is made at the beginning of the year and
that no day is omitted or duplicated in consecutive years.
(d)
Exemptions.
(1)
The agency may, upon application therefor or upon its
own initiative, exempt a source of radiation or a kind of use or user from
the requirements of this section if the agency determines that the exemption
is not prohibited by law and will not result in a significant risk to public
health and safety. In determining such exemptions, the agency will consider:
(A)
state of technology;
(B)
economic considerations in relation to benefits to the
public health and safety; and
(C)
other societal, socioeconomic, or public health and safety
considerations.
(2)
Electronic equipment that produces radiation
incidental to its operation for other purposes is exempt from the registration
and notification requirements of this section, provided that the dose equivalent
rate averaged over an area of 10 square centimeters does not exceed 0.5 millirem
per hour at 5 centimeters from any accessible surface of such equipment. The
production, testing, or factory servicing of such equipment shall not be exempt.
(3)
Radiation machines in transit or in storage incident
to transit are exempt from the requirements of this section. This exemption
does not apply to the providers of radiation machines for mobile services.
Facilities that have placed all radiation machines in storage, including storage
in place, and have notified the agency in writing, are exempt from the requirements
of this section. This exemption is void if any radiation machine is energized
resulting in the production of radiation.
(4)
Inoperable radiation machines are exempt from the
requirements of this section. For the purposes of this section, an inoperable
radiation machine means a radiation machine that cannot be energized when
connected to a power supply without repair or modification.
(5)
Financial institutions that take possession of radiation
machines as the result of foreclosure, bankruptcy, or other default of payment
are exempt from the requirements in this section to the extent that they demonstrate
that the radiation machine is operable for the sole purpose of selling, leasing,
or transferring.
(6)
No individual monitoring shall be required for personnel
operating only dental radiation machines for dental diagnostic purposes. However,
if the registrant chooses to provide individual monitoring, the registrant
should comply with the individual monitoring requirements of §289.231(n)
and (q)-(s) of this title (relating to General Provisions and Standards for
Protection Against Machine-Produced Radiation).
(7)
Portable radiation machines designed to be hand-held
are exempt from the requirements of subsection (i)(6)(D) of this section.
The portable radiation machines must be held by the tube housing support or
handle.
(8)
Individuals who are sole practitioners and sole operators
and the only occupationally exposed individual are exempt from the following
requirements:
(A)
subsection (i)(3) of this section; and
(B)
subsection (i)(5)(C) of this section.
(9)
In accordance with the Dental Practice Act,
Texas Civil Statutes, Article 4551o, dental practices are exempt from the
Medical Physics Practice Act, Texas Civil Statutes, Article 4512n. Dentists
required to have tests performed in accordance with subsection (i)(6)(J)(i)
of this section may select any qualified person authorized by registration
through the Bureau of Radiation Control.
(10)
A registrant is not required to post caution signs
in areas or rooms containing radiation machines for periods of less than eight
hours, if each of the following conditions is met:
(A)
the radiation machines are constantly attended during
these periods by an individual who takes the precautions necessary to prevent
the exposure of individuals to radiation in excess of the limits established
in this section; and
(B)
the area or room is subject to the registrant's control.
(e)
Communications.
(1)
Except where otherwise specified, all communications and
reports concerning this chapter and applications filed under them should be
mailed by postal service to the Bureau of Radiation Control, Texas Department
of Health, 1100 West 49th Street, Austin, Texas, 78756-3189. Communications,
reports, and applications may be delivered in person to the agency's office
located at 8407 Wall Street, Austin, Texas.
(2)
Documents received by the agency will be deemed to
have been received on the date of the postmark, telegram, telefacsimile, or
electronic media transmission.
(f)
Interpretations. Except as specifically authorized by
the agency in writing, no interpretation of the meaning of this chapter by
any officer or employee of the agency other than a written interpretation
by the Office of General Counsel, Texas Department of Health, will be considered
binding upon the agency.
(g)
Fees for Certificates of Registration for Dental Facilities.
(1)
Payment of fees.
(A)
Each application for a certificate of registration for
which a fee is prescribed in paragraph (2) of this subsection shall be accompanied
by a nonrefundable fee equal to the appropriate annual fee. No application
will be accepted for filing or processed prior to payment of the full amount
specified. For facilities possessing ten or more machines at a single authorized
use location, the fee is specified in paragraph (2) of this subsection.
(B)
A nonrefundable fee, in accordance with paragraph (2)
of this subsection, shall be paid annually for each certificate of registration
for radiation machines. For facilities possessing one to nine machines at
a single authorized use location, the fee consists of a base fee plus a fee
for each machine possessed.
(C)
Each application for reciprocal recognition of an out-of-state
registration in accordance with subsection (h)(8) of this section shall be
accompanied by the applicable annual fee, provided that no such fee has been
submitted within 12 months of the date of commencement of the proposed activity.
(D)
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 central office, 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.
(2)
Schedule of annual fees for certificates of
registration for dental radiation machines. The annual fees for certificates
of registration for dental radiation machines include the following:
Figure: 25 TAC §289.232(g)(2)
(3)
Failure to pay prescribed fees.
(A)
In any case where the agency finds that an applicant for
a certificate of registration has failed to pay the fee prescribed in this
section, the agency will not process that application until such fee is paid.
(B)
In any case where the agency finds that a registrant has
failed to pay a fee prescribed by this section by the due date, the registrant
shall pay an annual late payment fee of 20% of the annual fee prescribed in
this paragraph and paragraph (2) of this subsection, in addition to the annual
registration fee. The annual late payment fee shall not exceed $10,000 for
each registrant who fails to pay the fees prescribed by this section.
(C)
In any case where the agency finds that a registrant has
failed to pay a fee prescribed by this section by the due date, the agency
may implement compliance procedures as provided in subsection (k)(2)(C) of
this section.
(h)
Registration of Radiation Machine Use.
(1)
Application for registration.
(A)
Each person having a radiation machine used in dentistry
shall apply for registration with the agency within 30 days following the
commencement of the operation of the radiation machine, except for mobile
services that shall be registered in accordance with paragraph (4) of this
subsection and clinical trial evaluations that shall be registered in accordance
with paragraph (4)(F) of this subsection.
(B)
Application for registration shall be completed on forms
prescribed by the agency and shall contain all the information required by
the form and accompanying instructions.
(C)
The applicant shall be qualified by reason of training
and experience to use the radiation machines for the purpose requested in
accordance with this section in such a manner as to minimize danger to public
health and safety.
(D)
A radiation safety officer shall be designated on each
application form. The qualifications of that individual shall be submitted
to the agency with the application. The radiation safety officer shall meet
the applicable requirements of paragraph (9) of this subsection and carry
out the responsibilities of paragraph (10) of this subsection.
(E)
An application for use of a radiation machine in dentistry
must be signed by a licensed dentist. The signature of the administrator,
president, or chief executive officer will be accepted in lieu of a licensed
dentist's signature if the facility is a licensed hospital or a medical facility
with more than ten radiation machines. The application shall also be signed
by the radiation safety officer if the radiation safety officer is someone
other than the licensed dentist.
(F)
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 certificate of registration should be issued or denied.
(G)
An application for a certificate of registration may include
a request for a certificate of registration authorizing one or more activities.
If an application includes a request for an additional authorization other
than use of a radiation machine in dentistry, compliance with other applicable
sections of this chapter will be required.
(H)
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 subsection
(j)(1)(K)-(N) of this section.
(I)
Each application for a certificate of registration shall
be accompanied by the fee prescribed in subsection (g) of this section.
(J)
BRC Form 226-1, Franchise Tax Information Form, shall
be submitted with the application to confirm that no tax owed the state under
Tax Code, Chapter 171, is delinquent.
(K)
The applicant's proposed radiation machines, facilities,
and operating and safety procedures shall be adequate to minimize danger to
public health and safety.
(2)
Application for registration of mobile services
used in dentistry. In addition to the requirements of paragraph (1) of this
subsection, each applicant shall apply for and receive authorization for mobile
services before beginning mobile service operation. The following shall be
submitted.
(A)
An established main location where the machine, records,
etc. will be maintained for inspection. This must be a street address, not
a post office box number.
(B)
A sketch or description of the normal configuration of
each x-ray machine's use, including the operator's position and any ancillary
personnel's location during exposures. If a mobile van is used with a fixed
radiation machine inside, furnish the floor plan indicating protective shielding
and the operator's location.
(C)
For dental radiation machines used in mobile services,
current copy of the applicant's operating and safety procedures regarding
radiological practices for protection of patients, operators, employees, and
the general public.
(3)
Issuance of certificate of registration.
(A)
Upon a determination that an application meets the requirements
of the Texas Radiation Control Act and the rules of the agency, the agency
may issue a certificate of registration authorizing the proposed activity
in such form and containing such conditions and limitations as it deems appropriate
or necessary.
(B)
The agency may incorporate in the certificate of registration
at the time of issuance, or thereafter by amendment, such additional requirements
and conditions with respect to the registrant's possession, use, and transfer
of radiation machines subject to this section as it deems appropriate or necessary
in order to:
(i)
minimize danger to public health and safety;
(ii)
require such reports and the keeping of such records,
and to provide for such inspections of activities under the registration as
may be appropriate or necessary; and
(iii)
prevent loss or theft of radiation machines subject
to this section.
(4)
Specific terms and conditions of certificates
of registration.
(A)
Each certificate of registration issued in accordance
with this section shall be subject to the applicable provisions of the Texas
Radiation Control Act, now or hereafter in effect, and to the applicable rules
and orders of the agency.
(B)
No certificate of registration issued or granted under
this section shall be transferred, assigned, or in any manner disposed of,
either voluntarily or involuntarily, to any person unless the agency authorizes
the transfer in writing.
(C)
Each person registered by the agency for radiation machine
use in accordance with this section shall confine use and possession of the
radiation machine registered to the locations and purposes authorized in the
certificate of registration.
(D)
The registrant shall notify the agency within 30 days
of any changes that would render the information contained in the application
for registration and/or the certificate of registration inaccurate.
(E)
The following criteria applies to loaner radiation machines
and radiation machines used for clinical trial evaluations.
(i)
Radiation machines used for clinical trial evaluations
and loaner radiation machines may be used for up to 60 days without adding
the radiation machines to an existing certificate of registration. The facility
is required to notify the agency in writing of the period of use. If the use
period will exceed 60 days, the facility will be required to add the radiation
machines to their certificate of registration and a fee will be assessed.
(ii)
Facilities who do not have existing certificates of registration
may not evaluate radiation machines unless an application for a certificate
of registration has been submitted to the agency along with the appropriate
fees prior to beginning use of the radiation machine.
(iii)
No fees will be assessed for the operation of loaner
radiation machines or evaluation periods of 60 days or less unless the loaner
radiation machines or evaluation periods are in a facility described in clause
(ii) of this subparagraph.
(F)
The following applies to voluntary or involuntary petitions
for bankruptcy.
(i)
Each registrant shall notify the agency, in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy.
(ii)
The notification specified in clause (i) of this subparagraph
must include:
(I)
the bankruptcy court in which the petition for bankruptcy
was filed; and
(II)
the date of the filing of the petition.
(iii)
A copy of the "petition for bankruptcy" shall be submitted
to the agency along with the written notification.
(G)
The registrant is responsible for complying with this
section and the conditions of the certificate of registration.
(H)
No person shall use machines that are not authorized in
the certificate of registration issued by the agency.
(5)
Expiration of certificates of registration.
(A)
Except as provided by paragraph (7) of this subsection,
each certificate of registration that specifies an expiration date expires
at the end of the day on that date. Expiration of the certificate of registration
does not relieve the registrant of the requirements of this section.
(B)
If a registrant does not submit an application for renewal
of the certificate of registration under paragraph (7) of this subsection,
as applicable, the registrant shall on or before the expiration date specified
in the certificate of registration:
(i)
terminate use of all radiation machines;
(ii)
submit a record of the disposition of the radiation machines;
and
(iii)
pay any outstanding fees in accordance with subsection
(g) of this section.
(6)
Termination of certificates of registration.
When a registrant decides to terminate all activities involving radiation
machines authorized under the certificate of registration, the registrant
shall notify the agency immediately and:
(A)
request termination of the certificate of registration
in writing;
(B)
submit a record of the disposition of the radiation machines;
and
(C)
pay any outstanding fees in accordance with subsection
(g) of this section.
(7)
Renewal of certificate of registration.
(A)
Application for renewal of registration shall be filed
in accordance with paragraph (1) of this subsection.
(B)
If a registrant files an application in proper form before
the existing certificate of registration expires, such existing certificate
of registration shall not expire until the application status has been determined
by the agency.
(8)
Reciprocal recognition of out-of-state certificates
of registration.
(A)
Whenever any radiation machine is to be brought into the
state for any temporary use, the person proposing to bring such machine into
the state shall file written notice with the agency at least three working
days before such machine is to be used in the state. The notice shall include:
(i)
the number and type of radiation machines;
(ii)
the nature, start date, duration, and scope of use;
(iii)
the exact location where the radiation machines are
to be used;
(iv)
the name of the Texas licensed dentist;
(v)
a copy of the person's operating and safety procedures;
and
(vi)
the name and address where the machine users can be reached
while in the state.
(B)
If, for a specific case, the three-day period would impose
an undue hardship on the person, he/she may, at the determination of the agency,
obtain permission to proceed sooner.
(C)
The out-of-state person shall provide a copy of their
certificate of registration or equivalent document. If the state from which
the machines are proposed to be brought does not issue certificates of registration
or equivalent documents, a certificate of registration must be obtained from
the agency in accordance with the provisions of this section.
(D)
In addition, the out-of-state person shall:
(i)
submit an annual fee as specified in subsection (g)(1)(D)
of this section;
(ii)
comply with all applicable requirements of the agency;
and
(iii)
supply the agency with such other information as the
agency may reasonably request.
(E)
The agency may withdraw, limit, or qualify its acceptance
of any certificate of registration or equivalent document issued by another
agency upon determining that such action is necessary in order to prevent
undue hazard to public health and safety or property.
(9)
Training and qualification requirements for
radiation safety officers.
(A)
All radiation safety officers shall meet the following
training requirements:
(i)
educational courses related to ionizing radiation safety
or a radiation safety officer course;
(ii)
experience in the use and familiarity of the type of
radiation machine used; and
(iii)
knowledge of potential radiation hazards or emergency
precautions.
(iv)
licensed dentist radiation safety officers with documentation
of licensing board number; or
(v)
non-practitioner radiation safety officers with the following:
(I)
evidence of a valid general certificate issued under the
Medical Radiologic Technologist Certification Act, Texas Civil Statutes, Article
4512m, and at least two years of supervised use of radiation machines;
(II)
evidence of a valid limited general certificate issued
under the Medical Radiologic Technologist Certification Act, Texas Civil Statutes,
Article 4512m, and at least four years of supervised use of radiation machines;
(III)
evidence of registry by the American Registry of Radiologic
Technologists (ARRT) or the American Registry of Clinical Radiologic Technologists
(ARCRT) and at least two years of supervised use of radiation machines;
(IV)
evidence of associate degree in radiologic technology,
health physics, or nuclear technology, and at least two years of supervised
use of radiation machines;
(V)
evidence of registration with the Board of Nurse Examiners
as a Registered Nurse or a Registered Nurse with an extended scope of practice
(Nurse Practitioner) performing radiologic procedures, and at least two years
of supervised use of radiation machines in the respective practitioners' specialty;
(VI)
evidence of registration with the Texas State Board of
Physician Assistant Examiners, and at least two years of supervised use of
radiation machines in the respective practitioners' specialty;
(VII)
evidence of:
(-a-)
registration with the Texas State Board of Dental Examiners
performing radiologic procedures under a dentist's instruction and direction
or evidence of a valid certificate as a registered dental hygienist; and
(-b-)
at least four years of supervised use of radiation
machines in the respective dentists' specialty;
(VIII)
evidence of bachelor's (or higher) degree in a natural
or physical science, health physics, radiological science, nuclear medicine,
or nuclear engineering; or
(IX)
evidence of a current Texas license under the Medical
Physics Practice Act, Texas Civil Statutes, Article 4512n, in medical health
physics, diagnostic radiological physics, or medical nuclear physics for diagnostic
x-ray facilities.
(B)
Academic institutions and/or research and development
facilities shall have radiation safety officers who are faculty or staff members
in radiation protection, radiation engineering, or related disciplines. (This
individual may also serve as the radiation safety officer over the dental
section of the facility).
(C)
The radiation safety officer identified on a certificate
of registration issued before September 1, 1993, need not comply with the
training requirements in this subsection.
(10)
Responsibilities of radiation safety officers.
Specific duties of the radiation safety officer include, but are not limited
to, the following:
(A)
establishing and overseeing operating and safety procedures
that maintain radiation exposures as low as reasonably achievable, and to
review them regularly to ensure that the procedures are current and conform
with this section;
(B)
if individual monitoring is provided, ensuring that individual
monitoring devices are properly used by occupationally-exposed personnel,
that records of the monitoring results are maintained, and that timely notifications
are made as required by subsections (k) and (n) of this section;
(C)
investigating and reporting to the agency each known or
suspected case of radiation exposure to an individual or radiation level detected
in excess of limits established by this section and each theft or loss of
radiation machines, determining the cause, and taking steps to prevent its
recurrence;
(D)
having a thorough knowledge of management policies and
administrative procedures of the registrant;
(E)
assuming control and having the authority to institute
corrective actions including shut-down of operations when necessary in emergency
situations or unsafe conditions;
(F)
maintaining records as required by this section;
(G)
ensuring that personnel are adequately trained and complying
with this section, the conditions of the certificate of registration, and
the operating and safety procedures of the registrant.
(i)
Use of Radiation Machines in Dentistry.
(1)
As low as reasonably achievable. The registrant shall
use, to the extent practical, procedures and engineering controls based upon
sound radiation protection principles to achieve occupational doses and public
doses that are as low as reasonably achievable.
(2)
Prohibited uses.
(A)
The agency may prohibit use of dental radiation machines
that pose significant threat or endanger public health and safety, in accordance
with subsections (a)-(f), (i)(1) and (2), and (k)(2) of this section.
(B)
Individuals shall not be exposed to the useful beam except
for healing arts purposes and unless such exposure has been authorized by
a dentist. This provision specifically prohibits deliberate exposure for the
following purposes:
(i)
exposure of an individual for training, demonstration,
or other non-healing arts purposes;
(ii)
exposure of an individual for the purpose of research
except as authorized by subsection (i)(7) of this section.
(3)
Operating and safety procedures. Each registrant
shall have and implement written operating and safety procedures. These procedures
shall be made available to each individual operating a radiation machine,
including any restrictions of the operating technique required for the safe
operation of the particular x-ray system. These procedures shall include,
but are not limited to, the following procedures as applicable.
(A)
use of a technique chart in accordance with paragraph
(6)(B) of this subsection;
(B)
radiation dose requirements in accordance with subsection
(i)(4)(A) of this section;
(C)
holding of patients or film in accordance with subsection
(i)(12)(A), (C) and (D) of this section;
(D)
film processing program in accordance with paragraphs
(13) and (14) of this subsection;
(E)
posting notices to workers in accordance with subsection
(i)(5)(C) of this section;
(F)
instructions to workers in accordance with subsection
(i)(4)(D) of this section;
(G)
notifications and reports to individuals in accordance
with subsection (j)(3)(B) and (C) of this section;
(H)
ordering x-ray exams in accordance with subsection (b)(1)
of this section; and
(I)
posting of a radiation area in accordance with subsection
(i)(5)(B) of this section.
(4)
Personnel requirements.
(A)
Occupational dose limits.
(i)
The registrant shall control the occupational dose to
individuals, to the following dose limits.
(I)
An annual limit shall be the total effective dose equivalent
being equal to 5 rems (0.05 sievert).
(II)
The annual limits to the lens of the eye, to the skin,
and to the extremities shall be:
(-a-)
a lens dose equivalent of 15 rems (0.15 sievert); and
(-b-)
a shallow dose equivalent of 50 rems (0.5 sievert)
to the skin or to any extremity.
(III)
The annual limits for a minor shall be 10% of the annual
occupational dose limits specified in subclauses (I) and (II) of this clause.
(IV)
If a woman declares her pregnancy, the registrant shall
ensure that the dose equivalent to an embryo/fetus during the entire pregnancy,
due to occupational exposure of a declared pregnant woman, does not exceed
0.5 rem (5 millisievert). If a woman chooses not to declare pregnancy, the
occupational dose limits specified in subclauses (I) and (II) of this clause
are applicable to the woman.
(ii)
The assigned deep dose equivalent and shallow dose equivalent
shall be for the portion of the body receiving the highest exposure.
(iii)
The deep dose equivalent, lens dose equivalent, and
shallow dose equivalent may be assessed from surveys, calculations, or radiation
measurements for the purpose of demonstrating compliance with the occupational
dose limits, if the individual monitoring device was not in the region of
highest potential exposure, or the results of individual monitoring are unavailable.
(iv)
The registrant shall reduce the dose that an individual
may be allowed to receive in the current year by the amount of occupational
dose received from radiation machines or radioactive materials while employed
by any other person.
(B)
Dose limits for individual members of the public.
(i)
Each registrant shall conduct operations so that:
(I)
the total effective dose equivalent to individual members
of the public from exposure to radiation from radiation machines does not
exceed 0.5 rem (5 millisieverts) in a year, exclusive of the dose contribution
from background radiation, exposure of patients to radiation for the purpose
of medical diagnosis or therapy, or to voluntary participation in medical
research programs; and
(II)
the dose in any unrestricted area from external exposure
to radiation from radiation machines does not exceed 0.002 rem (0.02 millisieverts)
in any one hour.
(ii)
If the registrant permits members of the public to have
access to restricted areas, the limits for members of the public continue
to apply to those individuals.
(iii)
The agency may impose additional restrictions on radiation
levels in unrestricted areas in order to restrict the collective dose.
(C)
Occupational doses from other sources of radiation. Individuals
who receive occupational doses from sources of radiation other than dental
radiation machines may be required to comply with the requirements of §289.231(n)
and (q)-(s) of this title.
(D)
Instructions to workers.
(i)
All individuals likely to receive in a year an occupational
dose in excess of 100 millirem (1 millisievert) shall be:
(I)
kept informed of the storage, transfer, or use of radiation
machines in the registrant's workplace;
(II)
instructed in the health protection problems associated
with exposure to radiation, in precautions or procedures to minimize exposure,
and in the purposes and functions of protective devices employed;
(III)
instructed in, and instructed to observe, to the extent
within the worker's control, the applicable provisions of agency requirements
and certificates of registration, for the protection of personnel from exposures
to radiation occurring in such areas;
(IV)
instructed of their responsibility to report promptly
to the registrant any condition that may constitute, lead to, or cause a violation
of agency requirements or certificate of registration conditions, or unnecessary
exposure to radiation;
(V)
instructed in the appropriate response to warnings made
in the event of any unusual occurrence or malfunction that may involve exposure
to radiation; and
(VI)
advised as to the radiation exposure reports that workers
may request in accordance with subsection (j)(3)(D) of this section.
(ii)
The extent and frequency of these instructions shall
be commensurate with potential radiological health protection problems associated
with the radiation machines in the workplace.
(5)
Facility requirements.
(A)
General surveys and monitoring.
(i)
Each registrant shall make, or cause to be made, surveys
that:
(I)
are necessary for the registrant to comply with this section;
and
(II)
are necessary under the circumstances to evaluate:
(-a-)
the magnitude and extent of radiation levels; and
(-b-)
the potential radiological hazards.
(ii)
The registrant shall ensure that instruments and equipment
used for quantitative radiation measurements, including entrance exposure,
are operable and calibrated:
(I)
by a person licensed or registered by the agency, another
agreement state, a licensing state, or the United States Nuclear Regulatory
Commission to perform such service;
(II)
at intervals not to exceed 12 months;
(III)
after each instrument or equipment repair;
(IV)
for the types of radiation used and at energies appropriate
for use; and
(V)
at an accuracy within 20% of the true radiation level.
(B)
Caution signs. Unless otherwise authorized by the agency,
the standard radiation symbol prescribed shall use the colors magenta, or
purple, or black on yellow background. The standard radiation symbol prescribed
is the three-bladed design as follows:
Figure: 25 TAC §289.232(i)(5)(B)
(i)
the cross-hatched area of the symbol is to be magenta,
or purple, or black; and
(ii)
the background of the symbol is to be yellow.
(C)
Posting of notices to workers.
(i)
Each registrant shall post current copies of the following
documents:
(I)
this section;
(II)
the certificate of registration and conditions or documents
incorporated into the certificate of registration by reference, and amendments
thereto;
(III)
the operating procedures applicable to work under the
certificate of registration; and
(IV)
any notice of violation, if applicable, involving radiological
working conditions, or order issued in accordance with subsections (b) and
(k)(2) of this section and documentation of the corrections of any violations.
(ii)
If posting of a document specified in clause (i) of this
subparagraph is not practicable, the registrant shall post a notice that describes
the document and states where it may be examined.
(iii)
Bureau of Radiation Control (BRC) Form 232-1, "Notice
to Employees," as contained in subparagraph (D) of this paragraph, or an equivalent
document containing at least the same wording as BRC Form 232-1, shall be
posted by each registrant as required by this section.
(iv)
Documents, notices, or forms posted in accordance with
this subsection shall:
(I)
appear in a sufficient number of places to permit individuals
engaged in work under the certificate of registration to observe them on the
way to or from any particular work location to which the document applies;
(II)
shall be conspicuous; and
(III)
shall be replaced if defaced or altered.
(D)
Notice to employees. The following form, or an equivalent
as stated in subparagraph (C)(ii) of this paragraph, shall be posted.
Figure: 25 TAC §289.232(i)(5)(D)
(E)
Posting requirements. The registrant shall post each radiation
area with a conspicuous sign or signs bearing the radiation symbol and the
words "CAUTION, RADIATION AREA."
(F)
Exceptions to posting requirements. A registrant is not
required to post caution signs in areas or rooms containing radiation machines
for periods of less than 8 hours, if each of the following conditions is met:
(i)
the radiation machines are constantly attended during
these periods by an individual who takes the precautions necessary to prevent
the exposure of individuals to radiation in excess of the limits established
in this section; and
(ii)
the area or room is subject to the registrant's control.
(6)
Radiation machine requirements.
(A)
Inventory.
(i)
Each registrant shall annually inventory all radiation
machines possessed.
(ii)
Notification is required within 30 days of any change
of radiation machine inventory. This includes installation or removal and
the disposition of any machine disposed of or transferred. The assembler's
notification of installation may be accepted in lieu of notification by the
registrant. This does not relieve the registrant of the responsibility to
assure that proper notification has been made.
(B)
Technique chart.
(i)
A technique chart relevant to the particular x-ray machine
shall be provided or electronically displayed in the vicinity of the control
panel and used by all operators.
(ii)
Technique and exposure indicators.
(I)
The technique factors to be used during an exposure shall
be indicated before the exposure begins except when automatic exposure controls
are used, in which case the technique factors that are set prior to the exposure
shall be indicated.
(II)
On radiation machines having fixed technique factors,
the requirement of subclause (I) of this clause may be met by permanent markings.
(III)
The x-ray control shall provide visual indication of
the production of x rays.
(IV)
The indicated technique factors shall be accurate to
within manufacturer's specifications. If these specifications are not available
from the manufacturer, the factors shall be accurate to within ±10%
of the indicated setting.
(C)
Labeling radiation machines. Each registrant shall ensure
that each radiation machine is labeled in a conspicuous manner that cautions
individuals that radiation is produced when it is energized. This label shall
be affixed in a clearly visible location on the face of the radiation machine.
(D)
Mechanical support of tube head. The tube housing assembly
shall be adjusted to remain stable during an exposure unless tube housing
movement is a designed function of the x-ray system. The tube housing assembly
supports shall not be hand-held.
(E)
Battery charge indicator. On battery-powered x-ray generators,
visual means shall be provided on the control panel to indicate whether the
battery is in a state of charge adequate for proper operation.
(F)
Radiation from components other than the diagnostic source
assembly. The radiation emitted by a component other than the diagnostic source
assembly shall not exceed 2 millirem in one hour at 5 centimeters from any
accessible surface of the component when it is operated in an assembled x-ray
system under any conditions for which it was designed. Measurement is averaged
over an area of 100 square centimeter with no linear dimension greater than
20 centimeters.
(G)
Beam quality. The following requirements apply to beam
quality.
(i)
Half-value layer.
(I)
The half-value layer of the useful beam for a given x-ray
tube potential shall not be less than the values shown in the following Table
II. If it is necessary to determine such half-value layer at an x-ray tube
potential that is not listed in Table II, linear interpolation may be made.
Figure: 25 TAC §289.232(i)(6)(G)(i)(I)
(II)
For capacitor energy storage equipment, compliance with
the requirements of subparagraph (G) of this paragraph shall be determined
with the maximum quantity of charge per exposure.
(ii)
Filtration controls. For x-ray systems that have variable
kilovolt peak and variable filtration for the useful beam, a device shall
link the kilovolt peak selector with the filters and shall prevent an exposure
unless the minimum amount of filtration required by clause (i) of this subparagraph
is in the useful beam for the given kilovolt peak that has been selected.
Any other system having removable filters shall be required to have the minimum
amount of filtration as required by clause (i)(I) of this subparagraph permanently
located in the useful beam during each exposure.
(H)
Multiple tubes. Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes that have been selected
shall be clearly indicated prior to initiation of the exposure. This indication
shall be both on the x-ray control panel and at or near the tube housing assembly
that has been selected.
(I)
X-ray control. An x-ray control shall be incorporated
into each x-ray system such that an exposure can be terminated by the operator
at any time, except for exposures of 0.5 second or less. Each x-ray control
shall be located in such a way as to permit the operator to remain in an area
of less than 2 millirem in any one hour during the entire exposure. The exposure
switch shall be of the continuous pressure type.
(J)
Equipment performance evaluation for dental facilities.
(i)
For all x-ray systems, the registrant shall perform, or
cause to be performed, tests necessary to assure proper function of equipment
with the indicated standard for each item specified. The following tests shall
be performed every four years after installation at the authorized use location.
(I)
Timer.
(-a-)
The accuracy of the timer shall meet the manufacturer's
specifications. If the manufacturer's specifications are not obtainable, the
timer accuracy shall be ±10% of the indicated time with testing performed
at 0.5 second.
(-b-)
Means shall be provided to terminate the exposure
at a preset time interval, a preset product of current and time, a preset
number of pulses, or a preset radiation exposure to the image receptor. In
addition, it shall not be possible to make an exposure when the timer is set
to a "zero" or "off" position if either position is provided.
(II)
Exposure reproducibility. When all technique factors
are held constant, including control panel selections associated with automatic
exposure control systems, the coefficient of variation of exposure for both
manual and automatic exposure control systems shall not exceed 0.05. This
requirement applies to clinically used techniques.
(III)
Kilovolt peak. If the registrant possesses documentation
of the appropriate manufacturer's kilovolt peak specifications, the radiation
machine shall meet those specifications. If the registrant does not possess
documentation of the appropriate manufacturer's kilovolt peak specifications,
the indicated kilovolt peak shall be accurate to within ñ 10% of the
indicated setting(s). For radiation machines with fewer than three fixed kilovolt
peak settings, the radiation machine shall be checked at those settings.
(IV)
Tube stability. The x-ray tube shall remain physically
stable during exposures. In cases where tubes are designed to move during
exposure, the registrant shall assure proper and free movement of the radiation
machine.
(V)
Collimation. Field limitation shall meet the requirements
of paragraph (11) of this subsection.
(VI)
Radiographic entrance exposure limits for dental facilities.
The in-air exposure determined for the technique used for the specified average
human adult patient thickness for routine intraoral (bite wing) dental radiography
shall not exceed the following entrance exposure limits.
(-a-)
450 millirem for dental intraoral at 60 kilovolt peak
and above; and
(-b-)
600 millirem for dental intraoral less than 60
kilovolt peak.
(ii)
Any items not meeting the specifications of the tests
shall be corrected or repaired. Correction or repair shall begin within 30
days following the check and shall be performed according to a plan designated
by the registrant. Correction or repair shall be completed no longer than
90 days from discovery unless authorized by the agency.
(K)
Security and control of radiation machines.
(i)
The registrant shall secure radiation machines from unauthorized
removal.
(ii)
The registrant shall use devices and/or administrative
procedures to prevent unauthorized use of radiation machines.
(L)
Modifications to radiation machines. The registrant shall
document modifications to radiation machines that would alter the use of the
radiation machine from the intended use as originally designed and manufactured.
(7)
Dental research. Any research using radiation
machines on humans must be approved by an Institutional Review Board as required
by 45 Code of Federal Regulations Part 46 and 21 Code of Federal Regulations
Part 56. The Institutional Review Board must include at least one dentist
to direct any use of radiation in accordance with subsection (b)(1) of this
section.
(8)
Educational facilities. Facilities conducting training
using non-humans are held to all the requirements of this section except for
paragraphs (13) and (14) of this subsection concerning film processing, and
paragraph (6)(J) of this subsection concerning equipment performance evaluation.
(9)
Certified radiation machines for dental facilities.
In addition to the requirements of this section, the registrant shall not
make, nor cause to be made, any modification of components or installations
of components certified in accordance with the United States Food and Drug
Administration Title 21, Code of Federal Regulations Part 1020, "Performance
Standards for Ionizing Radiation Emitting Products," as amended, in any manner
that could cause the installations or the components to fail to meet the requirements
of the applicable parts of the standards specified in Title 21, Code of Federal
Regulations Part 1020, except where a variance has been granted by the Director,
Center for Devices and Radiological Health, United States Food and Drug Administration.
A copy of the variance shall be maintained by the registrant in accordance
with subsection (k)(1)(X) of this section for inspection by the agency.
(10)
Additional requirements for dental intraoral systems.
(A)
Source-to-skin distance. X-ray systems designed for use
with an intraoral image receptor shall be provided with means to limit source-to-skin
distance to not less than:
(i)
18 centimeters if operable above 50 kilovolt peak; or
(ii)
10 centimeters if not operable above 50 kilovolt peak.
(B)
Field limitation. Radiographic systems designed for use
with an intraoral image receptor shall be provided with means to limit the
x-ray beam such that:
(i)
if the minimum source-to-skin distance is 18 centimeters
or more, the x-ray field at the minimum source-to-skin distance shall be restricted
to a dimension of no more than 7 centimeters; and
(ii)
if the minimum source-to-skin distance is less than 18
centimeters, the x-ray field at the minimum source-to-skin distance shall
be restricted to a dimension of no more than 6 centimeters.
(11)
Additional requirements for dental extraoral
systems.
(A)
Field limitation. Dental rotational panoramic systems
shall be provided with means to restrict the x-ray beam to the following:
(i)
the imaging slit in the transverse axis; and
(ii)
no more than a total of 0.5 inches larger than the imaging
slit in the vertical axis.
(B)
All other dental extraoral radiographic systems (e.g.,
cephalometric) shall be provided with means to restrict the x-ray field to
the image receptor. The x-ray field shall not exceed the image receptor by
more than:
(i)
2.0% of the source-to-image receptor distance for the
length or width of the image receptor for rectangular collimation; or
(ii)
2.0% of the source-to-image receptor distance for the
diagonal of the image receptor for circular or polygon collimation.
(12)
Additional operational controls.
(A)
Film holding devices shall be used except in individual
cases in which the dentist has determined that such holding devices are contraindicated.
Written operating and safety procedures required by paragraph (3) of this
subsection shall state the criteria under which the exception may apply.
(B)
The operator shall stand at least six feet from the useful
beam or behind a protective barrier. The operator shall maintain verbal, aural,
and visual contact with the patient.
(C)
The tube housing support shall be constructed and adjusted
so that the tube housing shall not drift from its set position during an exposure.
Neither the tube housing nor support housing shall be hand-held during an
exposure.
(D)
Holding of patient or film. When a patient or film must
be held during a radiation exposure, the procedures for selecting an individual
who holds or supports the patient or film, and the procedure that the holder
shall follow, shall be included in the written operating and safety procedures.
(13)
Automatic and manual film processing for dental
facilities and mobile dental services.
(A)
Films shall be developed in accordance with the time-temperature
relationships recommended by the film manufacturer. The specified developer
temperature for automatic processing and the time-temperature chart for manual
processing shall be posted in the darkroom. If the registrant determines an
alternate time-temperature relationship is more appropriate for a specific
facility, that time-temperature relationship shall be documented and posted.
(B)
Chemicals shall be replaced according to the chemical
manufacturer's or supplier's recommendations or at an interval not to exceed
three months.
(C)
Darkroom light leak tests shall be performed and any light
leaks corrected at intervals not to exceed six months.
(D)
Lighting in the film processing/loading area shall be
maintained with the filter, bulb wattage, and distances recommended by the
film manufacturer for that film emulsion or with products that provide an
equivalent level of protection against fogging.
(E)
Corrections or repairs of the light leaks or related deficiencies
in subparagraphs (C) and (D) of this paragraph shall be initiated within 72
hours of discovery and completed no longer than 15 days from detection of
the deficiency unless a longer time is authorized by the agency.
(F)
Documentation of the items in subparagraphs (B), (C),
and (E) of this paragraph shall be made in accordance with subsection (j)(2)(A)(vii)-(ix)
of this section.
(14)
Alternative processing systems. Users of daylight
processing systems, laser processors, self-processing film systems, or other
alternative processing systems shall follow manufacturer's recommendations
for image processing.
(j)
Records and reports.
(1)
General provisions for records and reports.
(A)
All records required by this section shall be accurate
and factual.
(B)
Records are only valid if stamped, initialed, or signed
and dated by authorized personnel or otherwise authenticated. Records, such
as letters, drawings, and specifications, shall include all pertinent information,
such as stamps, initials, and signatures.
(C)
Each registrant shall use the SI units gray, sievert,
and coulomb per kilogram, or the special units rad, rem, and roentgen, including
multiples and subdivisions, and shall clearly indicate the units of all quantities
on records required by this section.
(D)
The registrant shall make a clear distinction among the
quantities entered on the records required by this section, such as, total
effective dose equivalent, shallow dose equivalent, lens dose equivalent,
and deep dose equivalent.
(E)
Each record required by this section shall be legible
throughout the specified retention period.
(F)
The record shall be the original or a reproduced copy
or a microform, provided that the copy or microform is authenticated by authorized
personnel and that the microform is capable of producing a clear copy throughout
the required retention period.
(G)
The record may also be stored in electronic media with
the capability for producing legible, accurate, and complete records during
the required retention period.
(H)
The registrant shall maintain adequate safeguards against
tampering with and loss of records.
(I)
Subject to the limitations provided in the Texas Public
Information Act, Government Code, Chapter 552, all information and data collected,
assembled, or maintained by the agency are public records open to inspection
and copying during regular office hours.
(J)
Any person who submits written information or data to
the agency and requests that the information be considered confidential, privileged,
or otherwise not available to the public under the Texas Public Information
Act, shall justify such request in writing, including statutes and cases where
applicable, addressed to the agency.
(i)
Documents containing information that is claimed to fall
within an exception to the Texas Public Information Act shall be marked to
indicate that fact. Markings shall be placed on the document on origination
or submission.
(I)
The words "NOT AN OPEN RECORD" shall be placed conspicuously
at the top and bottom of each page containing information claimed to fall
within one of the exceptions.
(II)
The following wording shall be placed at the bottom of
the front cover and title page, or first page of text if there is no front
cover or title page:
Figure: 25 TAC §289.232(j)(1)(J)(i)(II)
(ii)
The agency requests, whenever possible, that all information
submitted under the claim of an exception to the Texas Public Information
Act be extracted from the main body of the application and submitted as a
separate annex or appendix to the application.
(iii)
Failure to comply with any of the procedures described
in subparagraphs (A) and (B) of this paragraph may result in all information
in the agency file being disclosed upon an open records request.
(K)
The agency will determine whether information falls within
one of the exceptions to the Texas Public Information Act. The Office of General
Counsel will be queried as to whether or not there has been a previous determination
that the information falls within one of the exceptions to the Texas Public
Information Act. If there has been no previous determination and the agency
believes that the information falls within one of the exceptions, an opinion
of the Attorney General will be requested. If the agency agrees in writing
to the request, the information shall not be open for public inspection unless
the Attorney General's office subsequently determines that it is not an exception.
(L)
Requests for information.
(i)
All requests for open records information must be in writing
and refer to documents currently in possession of the agency.
(ii)
The agency will ascertain whether the information may
be released or whether it falls within an exception to the Texas Public Information
Act.
(I)
The agency may take a reasonable period of time to determine
whether information falls within one of the exceptions to the Texas Public
Information Act.
(II)
If the information is determined to be public, it will
be presented for inspection and/or copies of documents will be furnished within
a reasonable period of time. A fee will be charged to recover agency costs
for copies.
(iii)
Original copies of public records may not be removed
from the agency. Under no circumstances shall material be removed from existing
records.
(2)
Specific record keeping requirements.
(A)
The registrant shall ensure that the following records
are made and/or maintained for each radiation machine and that each record
is maintained in accordance with subsection (k)(1)(X) of this section for
inspection by the agency.
(i)
Receipt, transfer, and disposal of radiation machines.
Records of receipt, transfer, and disposal of radiation machines shall uniquely
identify the radiation machine and include the date of the receipt, transfer,
and disposal.
(ii)
Surveys.
(I)
As applicable, include a unique identification of the
survey instrument used, and an exact description of the location of the survey.
(II)
The registrant shall retain the results of surveys to
determine the dose from external sources of radiation used, in the absence
of or in combination with individual monitoring data, in the assessment of
individual dose equivalents in accordance with subsection (d)(6) of this section
until the agency terminates each pertinent registration requiring the record.
(III)
Include the date and the identification of the person
making the record.
(iii)
Calibrations. Include the date and the identification
of the person making the record.
(iv)
Equipment performance evaluation tests. Records of the
test results, including any numerical readings, and any corrections or repairs
shall be maintained.
(v)
Inventory. Include the manufacturer name, model number,
and serial number from the control panel or console of the radiation machine.
(vi)
Modifications performed on the radiation machine.
(vii)
Corrections/repairs. Corrections/repairs for darkrooms
and film processing/loading areas shall include the date and initials of the
person performing these functions.
(viii)
Processor chemical replacement. Documentation shall
be made and maintained at the location where processor chemical replacement
is performed, or at the record location for mobile services, and shall include
the date and initials of the individual performing this function.
(ix)
Darkroom light leak tests. Documentation shall be made
and maintained at the location where darkroom light leak tests are performed,
or at the record location for mobile services, and shall include the date
and initials of the individual performing this function.
(B)
Copies of records required in accordance with paragraph
(A) of this subsection and by certificate of registration condition that are
relevant to operations at an additional authorized use location shall be maintained
at that location in addition to the main location specified on a certificate
of registration.
(3)
Reports.
(A)
Reports of stolen, lost, or missing radiation machines.
(i)
Each registrant shall report to the agency by telephone
a stolen, lost, or missing radiation machine immediately after its occurrence
becomes known to the registrant.
(ii)
Each registrant required to make a report in accordance
with clause (i) of this subparagraph shall, within 30 days after making the
telephone report, make a written report to the agency that includes the following
information:
(I)
a description of the radiation machine involved, including,
the manufacturer name, model and serial number;
(II)
a description of the circumstances under which the loss
or theft occurred;
(III)
a statement of disposition, or probable disposition,
of the radiation machine involved;
(IV)
exposures of individuals to radiation, circumstances
under which the exposures occurred, and the possible total effective dose
equivalent to persons in unrestricted areas;
(V)
actions that have been taken, or will be taken, to recover
the radiation machine; and
(VI)
procedures or measures that have been, or will be, adopted
to ensure against a recurrence of the loss or theft of radiation machines.
(iii)
Subsequent to filing the written report, the registrant
shall also report additional substantive information on the loss or theft
within 30 days after the registrant learns of such information.
(iv)
The registrant shall prepare any report filed with the
agency in accordance with this subsection so that names of individuals who
may have received exposure to radiation are stated in a separate and detachable
portion of the report.
(B)
Reports of incidents.
(i)
Notwithstanding other requirements for notification, each
registrant shall immediately report each event involving a radiation machine
possessed by the registrant that may have caused or threatens to cause an
individual to receive:
(I)
a total effective dose equivalent of 25 rems (0.25 sievert)
or more;
(II)
a lens dose equivalent of 75 rems (0.75 sievert) or more;
or
(III)
a shallow dose equivalent to the skin or extremities
of 250 rads (2.5 grays) or more.
(ii)
Each registrant shall, within 24 hours of discovery of
the event, report to the agency each event involving loss of control of a
radiation machine possessed by the registrant that may have caused, or threatens
to cause an individual to receive, in a period of 24 hours:
(I)
a total effective dose equivalent exceeding 5 rems (0.05
sievert);
(II)
a lens dose equivalent exceeding 15 rems (0.15 sievert);
or
(III)
a shallow dose equivalent to the skin or extremities
exceeding 50 rems (0.5 sievert).
(iii)
Registrants shall make the initial notification reports
required by clauses (i) and (ii) of this subparagraph by telephone to the
agency and shall confirm the initial notification report within 24 hours by
telegram, mailgram, or facsimile to the agency.
(iv)
The registrant shall prepare each report filed with the
agency in accordance with this section so that names of individuals who have
received exposure to sources of radiation are stated in a separate and detachable
portion of the report.
(C)
Reports of exposures and radiation levels exceeding the
limits.
(i)
In addition to the notification required by subparagraph
(B) of this paragraph, each registrant shall submit a written report within
30 days after learning of any of the following occurrences:
(I)
incidents for which notification is required by subparagraph
(B) of this paragraph;
(II)
doses in excess of any of the following:
(-a-)
the occupational dose limits for adults in subsection
(i)(4)(A)(i) of this section;
(-b-)
the occupational dose limits for a minor in subsection
(i)(4)(A)(i)(III) of this section;
(-c-)
the limits for an embryo/fetus of a declared pregnant
woman in subsection (i)(4)(A)(i)(IV) of this section;
(-d-)
the limits for an individual member of the public
in subsection (i)(4)(B) of this section; or
(-e-)
any applicable limit in the registration;
(III)
levels of radiation in:
(-a-)
a restricted area in excess of applicable limits in
the certificate of registration; or
(-b-)
an unrestricted area in excess of 10 times the
applicable limit set forth in this section or in the certificate of registration
conditions, whether or not involving exposure of any individual in excess
of the limits in subsection (i)(4)(B) of this section.
(ii)
Each report required by subparagraph (C)(i) of this paragraph
shall describe the extent of exposure of individuals to radiation, including,
as appropriate:
(I)
estimates of each individual's dose;
(II)
the levels of radiation involved;
(III)
the cause of the elevated exposures, dose rates; and
(IV)
corrective steps taken or planned to ensure against a
recurrence, including the schedule for achieving conformance with applicable
limits, and associated registration conditions.
(iii)
Each report filed in accordance with subparagraph (C)(i)
of this paragraph shall include for each individual exposed: the name, social
security number, and date of birth. With respect to the limit for the embryo/fetus
in subsection (i)(4)(A)(i)(IV) of this section, the identifiers should be
those of the declared pregnant woman. The report shall be prepared so that
this information is stated in a separate and detachable portion of the report.
(iv)
All registrants who make reports in accordance with subparagraph
(C)(i) of this paragraph shall submit the report in writing to the agency.
(D)
Reports to individuals of exposures.
(i)
If applicable, radiation exposure data for an individual
shall be reported to the individual as specified in this paragraph. The information
reported shall include data and results obtained in accordance with agency
requirements, orders, certificate of registration conditions, as shown in
records made and maintained by the registrant in accordance with this subsection.
Each notification and report shall:
(I)
be in writing;
(II)
include appropriate identifying data such as the name
of the registrant, the name of the individual, and the individual's identification
number;
(III)
include the individual's exposure information; and
(IV)
contain the following statement: "This report is furnished
to you under the provisions of the Texas Regulations for Control of Radiation,
25 Texas Administrative Code §289.232(i)(4)(A)-(C). You should preserve
this report for further reference."
(ii)
If applicable, each registrant shall advise each worker
annually of the worker's estimated dose as shown in records made and maintained
by the registrant in accordance with subparagraph (C) of this paragraph.
(iii)
At the request of a worker formerly engaged in activities
controlled by the registrant, each registrant shall furnish a written report
of the worker's exposure to radiation if individual monitoring was provided.
The report shall include the dose record for each year the worker was monitored
in accordance with subsection (d)(6) of this section. Such report shall be
furnished within 30 days from the date of the request, or within 30 days after
the dose of the individual has been determined by the registrant, whichever
is later. The report shall cover the period of time that the worker's activities
involved exposure to radiation and the dates and locations of work under the
certificate of registration in which the worker participated during this period.
(iv)
When a registrant is required in accordance with subparagraphs
(B) and (C) of this paragraph to report to the agency any exposure of an identified
occupationally exposed individual, or an identified member of the public,
to radiation, the registrant shall also notify the individual and provide
the individual with a copy of the report submitted to the agency, including
the information required by clause (i) of this subparagraph. Such reports
shall be transmitted at a time not later than the transmittal to the agency.
(v)
At the request of a worker who is terminating employment
with the registrant in work involving exposure to radiation during the current
year, each registrant shall provide at termination to each such worker, or
to the worker's designee, a written report regarding the radiation dose received
by that worker from operations of the registrant during the current year or
fraction thereof, if individual monitoring was provided. If the most recent
individual monitoring results are not available at that time, a written estimate
of the dose shall be provided together with a clear indication that this is
an estimate.
(k)
Compliance procedures.
(1)
Inspections.
(A)
The agency may enter public or private property at reasonable
times to determine whether, in a matter under the agency's jurisdiction, there
is compliance with the Texas Radiation Control Act, the agency's rules, certificate
of registration conditions, and orders issued by the agency.
(B)
Each registrant shall afford to the agency at all reasonable
times opportunity to inspect machines, activities, facilities, premises, and
records in accordance with this section.
(C)
During an inspection, agency inspectors may consult privately
with workers as specified in subparagraphs (I)-(R) of this paragraph. The
registrant may accompany agency inspectors during other phases of an inspection.
(D)
If, at the time of inspection, an individual has been
authorized by the workers to represent them during agency inspections, the
registrant shall notify the inspectors of such authorization and shall give
the workers' representative an opportunity to accompany the inspectors during
the inspection of physical working conditions.
(E)
Each workers' representative shall be routinely engaged
in work under control of the registrant and shall have received instructions
as specified in subsection (i)(4)(D) of this section.
(F)
Different representatives of registrants and workers may
accompany the inspectors during different phases of an inspection if there
is no resulting interference with the conduct of the inspection. However,
only one workers' representative at a time may accompany the inspectors.
(G)
With the approval of the registrant and the workers' representative,
an individual who is not routinely engaged in work under control of the registrant,
for example, a consultant to the registrant or to the workers' representative,
shall be afforded the opportunity to accompany agency inspectors during the
inspection of physical working conditions.
(H)
Notwithstanding the other provisions of this section,
agency inspectors are authorized to refuse to permit accompaniment by any
individual who deliberately interferes with a fair and orderly inspection.
With regard to any area containing proprietary information, the workers' representative
for that area shall be an individual previously authorized by the registrant
to enter that area.
(I)
Agency inspectors may consult privately with workers concerning
matters of occupational radiation protection and other matters related to
applicable provisions of agency regulations and certificates of registration
to the extent the inspectors deem necessary for the conduct of an effective
and thorough inspection.
(J)
During the course of an inspection any worker may bring
privately to the attention of the inspectors, either orally or in writing,
any past or present condition which that individual has reason to believe
may have contributed to or caused any violation of the Texas Radiation Control
Act, the requirements in this section, certificate of registration conditions,
or any unnecessary exposure of an individual to radiation from any radiation
machine under the registrant's control. Any such notice in writing shall comply
with the requirements of subparagraph (L) of this paragraph.
(K)
The provisions of subparagraph (J) of this paragraph shall
not be interpreted as authorization to disregard instructions in accordance
with subsection (i)(4)(D) of this section.
(L)
Any worker or representative of workers who believes that
a violation of the Texas Radiation Control Act, the requirements of this section,
or certificate of registration conditions exists or has occurred in work under
a certificate of registration with regard to radiological working conditions
in which the worker is engaged, may request an inspection by giving notice
of the alleged violation to the agency. Any such notice shall be in writing,
shall set forth the specific grounds for the notice, and shall be signed by
the worker or representative of the workers. A copy shall be provided to the
registrant by the agency no later than at the time of inspection except that,
upon the request of the worker giving such notice, the worker's name and the
name(s) of individual(s) referred to therein shall not appear in such copy
or on any record published, released, or made available by the agency, except
for good cause shown.
(M)
If, upon receipt of such notice, the agency determines
that the request meets the requirements set forth in subparagraph (L) of this
paragraph, and that there are reasonable grounds to believe that the alleged
violation exists or has occurred, an inspection shall be made as soon as practicable
to determine if such alleged violation exists or has occurred. Inspections
in accordance with this section need not be limited to matters referred in
the request.
(N)
No registrant, contractor or subcontractor of a registrant
shall discharge or in any manner discriminate against any worker because of
the following:
(i)
such worker has filed any request or instituted or caused
to be instituted any proceeding under this section;
(ii)
such worker has testified or is about to testify in any
such proceeding; or
(iii)
because of the exercise by such worker on behalf of
that individual or others of any option afforded by this section.
(O)
If the agency determines, with respect to a request under
subparagraphs (L)-(N) of this paragraph, that an inspection is not warranted
because there are no reasonable grounds to believe that a violation exists
or has occurred, the agency shall notify the requestor in writing of such
determination. The requestor may obtain review of such determination in accordance
with the provisions of the Texas Radiation Control Act and the Government
Code, Chapters 2001 and 2002.
(P)
If the agency determines that an inspection is not warranted
because the requirements of subparagraph (L) of this paragraph have not been
met, the agency shall notify the requestor in writing of such determination.
Such determination shall be without prejudice to the filing of a new request
meeting the requirements of subparagraph (L) of this paragraph.
(Q)
The routine inspection interval for dental facilities
is four years. On-site inspections and remote inspections may be alternated.
The inspection interval specified is based upon the average number of health-related
violations per inspection, as determined from compliance history data. This
interval will be reviewed at least every two years, and appropriate adjustments
will be made. Registrants having certificates of registration authorizing
multiple uses will be inspected on-site at the most frequent interval specified
for the uses authorized.
(R)
Notwithstanding the inspection interval specified in subparagraph
(Q) of this paragraph, the agency may inspect registrants more frequently
due to:
(i)
the persistence or severity of violations found during
an inspection;
(ii)
investigation of an incident or complaint concerning
the facility;
(iii)
a request for an inspection by a worker(s) in accordance
with subparagraphs (L)-(N) of this paragraph;
(iv)
any change in a facility or radiation machine that might
cause a significant increase in radiation output or hazard; or
(v)
a mutual agreement between the agency and registrant.
(S)
The agency will conduct inspections of dental radiation
machines in a manner designed to cause as little disruption of a dental practice
as is practicable.
(T)
For remote inspection of radiation machines, each registrant
shall:
(i)
respond to a request from the agency for a remote inspection;
(ii)
complete the remote inspection forms in accordance with
the instructions included with the forms; and
(iii)
return to the agency the completed remote inspection
forms with documentation of the most recent equipment performance evaluation
performed in accordance with subsection (i)(6)(J) of this section by the deadline
indicated on the forms.
(U)
Each registrant shall perform, upon instructions from
the agency, or shall permit the agency to perform such reasonable surveys
as the agency deems appropriate or necessary including, but not limited to,
surveys of:
(i)
radiation machines;
(ii)
facilities wherein radiation machines are used or stored;
(iii)
radiation detection and individual monitoring instruments;
and
(iv)
other equipment and devices used in connection with utilization
or storage of radiation machines.
(V)
A person who performs on-site inspection of dental radiation
machines will have training in the design and uses of the products as specified
in subparagraph (W) of this paragraph.
(W)
Training for agency inspectors of radiation machines.
(i)
Objectives. Training of agency inspectors of radiation
machines will be conducted by the agency. Upon completion of training, the
inspector will be able to:
(I)
select and operate the necessary testing equipment used
to perform an inspection of radiation machines;
(II)
utilize radiation protection principles;
(III)
operate radiation detection instruments;
(IV)
define basic regulatory terminology;
(V)
apply this section regarding radiation machines;
(VI)
perform routine agency inspections of radiation machines;
(VII)
complete agency inspection documentation;
(VIII)
demonstrate knowledge of agency ethics, professional,
and technical policies; and
(IX)
successfully achieve the objectives in this clause.
(ii)
Initial training program.
(I)
Initial training will be conducted during a six-month
period.
(II)
All training evaluation instruments will be developed
by the agency.
(III)
Instruments to be used in determining a proficiency
level are as follows:
(-a-)
evaluation of each inspector's training needs prior
to initial training;
(-b-)
evaluation of knowledge obtained and verification
of tasks performed by each inspector subsequent to training received by the
agency; and
(-c-)
evaluation of each inspector's task performance
by the agency.
(iii)
Continuing education.
(I)
The agency inspector of radiation machines will accumulate
24 hours of continuing education regarding radiation machines, at intervals
not to exceed 24 months. These hours of continuing education may be acquired
as follows:
(-a-)
documented continuing education earned in an agency-accepted
training format; and
(-b-)
agency staff meetings.
(II)
Failure to obtain 24 hours of continuing education within
each 24 month interval may result in a reassessment by the agency of an agency
inspector's proficiency level.
(III)
After the initial training period, each inspector of
radiation machines will be evaluated by the agency, at intervals not to exceed
12 months.
(iv)
Agency proficiency standards. The agency proficiency
standards for agency inspectors of radiation machines are as follows.
(I)
Level I. The agency inspector has not successfully achieved
the objectives in clause (i) of this subparagraph after the initial training
period. Additional training is required. Unsupervised inspections will not
be performed.
(II)
Level II. The agency inspector has partially achieved
the objectives in clause (i) of this subparagraph, but has not achieved the
objective in clause (i)(IX) of this subparagraph after the initial training
period. Additional training is required. Unsupervised inspections are not
permitted for the type of radiation machines for which the objectives of clause
(i)(IX) of this subparagraph have not been achieved. Unsupervised inspections
may be performed for the type of radiation machines for which the objectives
in clause (i)(IX) of this subparagraph have been successfully achieved.
(III)
Level III. The agency inspector has successfully achieved
the objectives in clause (i) of this subparagraph. Supervision is not required
for routine inspections.
(X)
Records/documents for agency inspection.
(i)
Each registrant shall make the following records/documents
available to the agency for inspection, upon reasonable notice.
Figure: 25 TAC §289.232(k)(1)(X)(i)
(ii)
For radiation machines authorized for mobile service,
copies of the records specified in clause (i)(I)-(VI) of this subparagraph
shall be maintained with the radiation machine in accordance with clause (i)
of this subparagraph for inspection by the agency. If on-board processors
are utilized, film processing records for the last two years shall also be
made on board in accordance with subsection (j)(2)(A)(vii)-(ix) of this section
and maintained in accordance with clause (i) of this subparagraph for inspection
by the agency.
(iii)
For authorized records locations for mobile services,
copies of the records specified in clause (i)(II), (III), (VI)-(IX), and (XI)
of this subparagraph shall be maintained with the radiation machine in accordance
with clause (i) of this subparagraph for inspection by the agency. In addition,
copies of film processing records for that location shall be made in accordance
with subsection (j)(2)(A)(vii)-(ix) of this section and maintained in accordance
with clause (i) of this subparagraph for inspection by the agency, excluding
the two years of on-board processing records.
(2)
Hearing and enforcement procedures.
(A)
Violations. An injunction or other agency order may be
obtained prohibiting any violation of any provision of the Texas Radiation
Control Act or any rule or order issued thereunder. Any person who violates
any provision of the Texas Radiation Control Act or any rule or order issued
thereunder may be subject to civil and/or administrative penalties. Such person
may also be guilty of a misdemeanor.
(B)
Denial of an application for a certificate of registration.
(i)
When the agency contemplates denial of an application
for a certificate of registration, the registrant shall be afforded the opportunity
for a hearing. Notice of the denial shall be delivered to the registrant by
personal service or certified mail, addressed to the last known address.
(ii)
Any applicant or registrant against whom the agency contemplates
denial of an application may request a hearing by writing the director within
30 days of service or date of mailing.
(I)
The written request for a hearing must contain the following:
(-a-)
statement requesting a hearing; and
(-b-)
name and address of the applicant or registrant;
(II)
Failure to submit a written request for a hearing within
30 days will render the agency action final.
(C)
Compliance procedures for registrants.
(i)
A registrant who commits a violation(s) will be issued
a notice of violation.
(ii)
The terms and conditions of all certificates of registration
shall be subject to amendment or modification. A certificate of registration
may be modified, suspended, or revoked by reason of amendments to the Texas
Radiation Control Act, or for violation of the Texas Radiation Control Act,
the requirements of this section, a condition of the certificate of registration,
or an order of the agency.
(iii)
Any certificate of registration may be modified, suspended,
or revoked in whole or in part, for any of the following:
(I)
any material false statement in the application or any
statement of fact required in accordance with provisions of the Texas Radiation
Control Act;
(II)
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 a certificate of registration on an original
application; or
(III)
violation of, or failure to observe applicable terms
and conditions of the Texas Radiation Control Act, this section, or of the
certificate of registration, or order of the agency.
(iv)
If another state or federal entity takes an action such
as modification, revocation, or suspension of the certificate of registration,
the agency may take a similar action against the registrant.
(v)
When the agency determines that the action provided for
in clause (viii) of this subparagraph or subparagraph (D) of this paragraph
is not to be taken immediately, the agency may offer the registrant an opportunity
to attend an enforcement conference.
(vi)
Notice of any enforcement conference shall be delivered
by personal service, or certified mail, addressed to the last known address.
An enforcement conference is not a prerequisite for the action to be taken
under clause (viii) of this subparagraph or subparagraph (D) of this paragraph.
(vii)
Except in cases in which the public health, interest,
or safety requires otherwise, no certificate of registration 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
accorded an opportunity to demonstrate compliance with all lawful requirements.
(viii)
When the agency contemplates modification, suspension,
or revocation of the certificate of registration, the registrant shall be
afforded the opportunity for a hearing. Notice of the contemplated action,
along with a complaint, shall be given to the registrant by personal service
or certified mail, addressed to the last known address.
(ix)
Any applicant or registrant against whom the agency contemplates
an action described in clause (viii) of this subparagraph may request a hearing
by writing the director within 30 days of service or date of mailing.
(I)
The written request for a hearing must contain the following:
(-a-)
statement requesting a hearing;
(-b-)
name, address, and identification number of the
registrant against whom the action is being taken.
(II)
Failure to submit a written request for a hearing within
30 days will render the agency action final.
(D)
Assessment of Administrative Penalties.
(i)
When the agency determines that monetary penalties are
appropriate, proposals for assessment of and hearings on administrative penalties
shall be made in accordance with the Texas Radiation Control Act, §401.384,
and applicable sections of the Formal Hearing Procedures, Chapter 1, §§1.21
- 1.34 of this title.
(ii)
Assessment of administrative penalties shall be based
on the following criteria:
(I)
the seriousness of the violation(s);
(II)
previous compliance history;
(III)
the amount necessary to deter future violations;
(IV)
efforts to correct the violation; and
(V)
any other mitigating or enhancing factors.
(iii)
Application of administrative penalties. The agency
may impose differing levels of penalties for different severity level violations
and different classes of users as follows.
(I)
Administrative penalties may be imposed for severity level
I and II violations. Administrative penalties will be considered for severity
level III, IV, and V violations when they are combined with those of higher
severity level(s) or for repeated violations that could have been prevented
by corrective action and for which the registrant did not take effective corrective
action.
(II)
The following Tables IA and IB show the base administrative
penalties.
Figure: 25 TAC §289.232(k)(2)(D)(iii)(II)
(III)
Adjustments to the severity levels and percentages in
Table IB may be made for the presence or absence of the following factors:
(-a-)
prompt identification and reporting;
(-b-)
corrective action to prevent recurrence;
(-c-)
compliance history;
(-d-)
prior notice of similar event;
(-e-)
multiple occurrences; and
(-f-)
negligence that resulted in or increased adverse
effects.
(IV)
The penalty may be in an amount not to exceed $10,000
a day for a person who violates the Texas Radiation Control Act or a rule,
order, or certificate of registration issued under the Texas Radiation Control
Act. Each day a violation continues may be considered a separate violation
for purposes of penalty assessment.
(iv)
The Office of General Counsel may conduct settlement
negotiations.
(E)
Severity levels of violations for registrants.
(i)
Violations for registrants shall be categorized by one
of the following severity levels.
(I)
Severity level I are violations that are most significant
and may have a significant negative impact on occupational and/or public health
and safety or on the environment.
(II)
Severity level II are violations that are very significant
and may have a negative impact on occupational and/or public health and safety
or on the environment.
(III)
Severity level III are violations that are significant
and which, if not corrected, could threaten occupational and/or public health
and safety or the environment.
(IV)
Severity level IV are violations that are of more than
minor significance, but if left uncorrected, could lead to more serious circumstances.
(V)
Severity level V are violations that are of minor safety
or environmental significance.
(ii)
Criteria to elevate or reduce severity levels.
(I)
Violations may be elevated to a higher severity level
for the following reasons:
(-a-)
more than one violation resulted from the same underlying
cause;
(-b-)
a violation contributed to or was the consequence
of the underlying cause, such as a management breakdown or breakdown in the
control of registered activities;
(-c-)
a violation occurred multiple times between inspections;
(-d-)
a violation was willful. This means the violation
was the result of careless regard for requirements, deception, or other indications
of willfulness by the registrant or employees of the registrant; or
(-e-)
compliance history.
(II)
Violations may be reduced to a lower level for the following
reasons:
(-a-)
the registrant identified and corrected the violation
prior to the agency inspection; or
(-b-)
the registrant's actions corrected the violation
and prevented recurrence.
(iii)
Examples of severity levels. Examples of severity levels
are available upon request to the agency.
(F)
Impoundment of radiation machines. Radiation machines
shall be subject to impounding in accordance with §401.068 of the Texas
Radiation Control Act and this paragraph.
(i)
In the event of an emergency, the agency shall have the
authority to impound or order the impounding of radiation machines possessed
by any person not equipped to observe or failing to observe the provisions
of the Texas Radiation Control Act, or any rules, certificate of registration
conditions, or orders issued by the agency. The agency shall submit notice
of the action to be published in the
Texas Register
no later than 30 days following the end of the month in which the
action was taken.
(ii)
At the agency's discretion, the impounded radiation machines
may be disposed of by:
(I)
returning the radiation machine to a properly registered
owner, upon proof of ownership, who did not cause the emergency;
(II)
releasing the radiation machine as evidence to police
or courts;
(III)
returning the radiation machine to a registrant after
the emergency is over and settlement of any compliance action; or
(IV)
sale, destruction or other disposition within the agency's
discretion.
(iii)
If agency action is necessary to protect the public
health and safety, no prior notice need be given the owner or possessor. If
agency action is not necessary to protect the public health and safety, the
agency will give written notice to the owner and/or the possessor of the impounded
radiation machine of the intention to dispose of the radiation machine. Notice
shall be the same as provided in subparagraph (C)(viii) of this paragraph.
The owner or possessor shall have 30 days from the date of personal service
or mailing to request a hearing under the Formal Hearing Procedures, Chapter
1, §§1.21 - 1.34 of this title, and in accordance with subparagraph
(C)(ix) of this paragraph, concerning the intention of the agency. If no hearing
is requested within that period of time, the agency may take the contemplated
action, and such action is final.
(iv)
Upon agency disposition of a source of radiation, the
agency may notify the owner and/or possessor of any expense the agency may
have incurred during the impoundment and/or disposition and request reimbursement.
If the amount is not paid within 60 days from the date of notice, the agency
may request the Attorney General to file suit against the owner/possessor
for the amount requested. If the owner/possessor desires to contest the amount
of such charge, the owner/possessor may request a hearing under the Formal
Hearing Procedures, Chapter 1, §§1.21 - 1.34 of this title and in
accordance with paragraph (2)(I) of this subsection.
(v)
If the agency determines from the facts available to the
agency that an impounded radiation machine is abandoned, with no reasonable
evidence showing its owner or possessor, the agency may make such disposition
of the radiation machine as it sees fit.
(G)
Emergency orders for certificates of registration.
(i)
When an emergency exists requiring immediate action to
protect the public health or safety or the environment, the agency may, without
notice or hearing, issue an order citing the existence of such emergency and
require that certain actions be taken as it shall direct to meet the emergency.
The agency shall, no later than 30 days following the end of the month in
which the action was taken, submit notice of the action for publication in
the
Texas Register
. The action taken will
remain in full force and effect unless and until modified by subsequent action
of the agency. These emergency orders shall apply to certificates of registration.
(ii)
An emergency order takes effect immediately upon service.
(iii)
Any person receiving an emergency order shall comply
immediately.
(iv)
The registrant shall be afforded the opportunity for
a hearing on an emergency order. Notice of the action, along with a complaint,
shall be given to the registrant by personal service or certified mail, addressed
to the last known address. A hearing shall be held on an emergency order if
the person receiving the order makes a written application to the agency for
a hearing within 30 days of the order date.
(I)
The hearing shall be held not less than 10 days nor more
than 20 days after receipt of the written application for hearing.
(II)
At the conclusion of the hearing and after the proposal
for decision is made as provided in the Texas Administrative Procedure Act,
Texas Government Code, Chapter 2001, the commissioner shall take one of the
following actions:
(-a-)
determine that no further action is warranted;
(-b-)
amend the certificate of registration;
(-c-)
revoke or suspend the certificate of registration;
(-d-)
rescind the emergency order; or
(-e-)
issue such other order as is appropriate.
(III)
The application and hearing shall not delay compliance
with the emergency order.
(H)
Miscellaneous provisions.
(i)
Computation of time. A time period established by the
requirements of this section shall begin on the first day after the event
that invokes the time period. When the last day of the period falls on a Saturday,
Sunday, or state or federal holiday, the period shall end on the next day
that is not a Saturday, Sunday, or state or federal holiday. The time period
shall expire at 5:00 p.m. of the last day of the computed period.
(ii)
Interested person.
(I)
An interested person may:
(-a-)
make sworn or unsworn statements;
(-b-)
attend a hearing and may present evidence after
the presentation of evidence by the parties; or
(-c-)
be represented by an attorney.
(II)
An interested person may not:
(-a-)
cross-examine the witnesses of the parties;
(-b-)
object to evidence presented by the parties; or
(-c-)
appeal a decision rendered by the agency.
(III)
An interested person is not responsible for sharing
the costs of the transcription of the hearing, but may purchase a transcript.
(IV)
The parties may cross-examine witnesses presented by
an interested person.
(V)
At the discretion of the ALJ an interested person may
make an unsworn statement. Such statement shall not be made a part of the
record.
(iii)
Hearing location. Hearings will be held at the offices
of the State Office of Administrative Hearings in Austin unless the ALJ specifies
another location.
(iv)
Prior testimony. Testimony and evidence presented in
the hearing to determine standing have the same weight at the hearing on the
merits if a tape recording or written transcript of the standing hearing is
available.
(v)
Non-party witness and mileage fees.
(I)
A witness or deponent who is not a party (or an employee,
agent, or representative of a party) and who is subpoenaed or otherwise compelled
to attend an agency hearing or a proceeding to give a deposition, or to produce
books, records, papers, accounts, documents, or other objects necessary and
proper for the purposes of the hearing or proceeding may receive reimbursement
for transportation and other costs at rates established by the current Appropriations
Act for state employees.
(II)
The person requesting the attendance of the witness or
deponent must deposit with the agency the funds estimated by the ALJ to accrue
in accordance with subclause (I) of this clause when filing a motion for the
issuance of a subpoena or a commission to take a deposition.
(vi)
Service. A return of service by the person who performed
personal service, postal return receipt, or proof of mailing to the last known
address shall be conclusive evidence of service.
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 10, 2000.
TRD-200002551
Susan K. Steeg
General Counsel
Texas Department of Health
Earliest possible date of adoption: May 21, 2000
For further information, please call: (512) 458-7236
Chapter 1301.
HEALTH CARE INFORMATION
Subchapter A. HOSPITAL DISCHARGE DATA RULES
The Texas Health Care Information Council (Council) proposes amendments
to §§1301.11 - 1301.18, the repeal and new of §1301.19, and
new §1301.20, concerning hospital discharge data rules. Existing §1301.19
is being repealed in order to propose a new regulation regarding a scientific
review panel. The language contained in existing §1301.19 is being amended
and proposed under a new §1301.20. This action is being done in order
to comply with the Texas Administrative Code numbering scheme. On July 9,
1999, the Texas Health Care Information Council (Council) published notice
in the
Texas Register
(24 TexReg 5219) of
the proposed review of Title 25, Part XVI, Chapter 1301, Subchapter A as required
by the General Appropriations Act, Article IX, Section 167, 75th Legislature.
The Subchapter A rules are referred to herein as the Hospital Discharge Data
Rules. The reasons for initially adopting the Hospital Discharge Data Rules
continue to exist: The Council is required by its enabling legislation in
Chapter 108 of the Health and Safety Code, specifically §108.006, to
"develop a statewide health care data collection system to collect health
care charges, utilization data, provider quality date, and outcome data to
facilitate the promotion and accessibility of cost-effective, good quality
health care."
The Council received comments on its review of the Hospital Discharge Data
Rules from the Texas Hospital Association (THA).
The amendments to the Hospital Discharge Data Rules proposed hereby results
from 1) the Council's analysis of THA's comments, 2) House Bill 1513 enacted
by the 76th Texas Legislature, and 3) input from the Council's Health Information
Systems Technical Advisory Committee (HIS TAC).
The Council proposes to remove the word "report" or "reports" and insert
the word "file" or "files" respectively in the following subsections: §1301.11
(Batch, Discharge File, Discharge Report, Error, Required minimum data set,
Submission and Submitter); §1301.12(a), §1301.12(b)(4)-(5), §1301.12(c)
- (g); §1301.13(Section Title), (a){does not include paragraphs 1 - 4
of subsection (a)}, §1301.13(d); §1301.14(Section Title), (a), (a)(4),
(b), (c){does not include paragraphs 1 - 3 of subsection (c)}; §1301.15(a)(1),
(a)(2), (a)(2)(A), (a)(previously 3, changed to 4), (a)(previously 4, changed
to 5); §1301.16(Section Title), (b), (b)(1), (b)(3), (c)(1), (c)(2),
(e); §1301.17(previously "e," changed to "f"); §1301.18(h); §1301.20(Section
Title), (a), (a)(1), (f).
The Council proposes removing the words "report" and "reports"and inserting
the words "encounter data" in the following subsections: §1301.17(Section
Title), (b), (c); §1301.18(e)(3), (e)(4).
The Council proposes adding the word "calendar" before the word "days"
to clarify the length of time for specific events to occur in the following
subsections: §1301.12(e) - (g); §1301. 13(a), (c); §1301.14(a)
- (c); §1301.15(a) - (c); §1301.16(b) - (c); §1301.17(b); §1301.20(c).
The proposed amendments delete the word "admitting" and insert the word
"attending" in subsections §1301.11 and 1301.17(a).
The Council proposes to define "Attending Physician," "Certification,"
"Discharge Encounter," "Edit," "ICD," "Provider quality data," "Research Data
File," "Scientific Review Panel," "Treating Physician" and "Validation" in §1301.11.
The Council proposes to remove the definition of "Geographic Identifier" because
of the amendments to §108.103(c) from Section 7 of HB1513 (76th Texas
Legislature). The Council proposes to remove the definitions of "Health benefit
plan," and "Uniform Payer identifier" because the terms are not used in the
rules. The Council assigned numbers to the definitions as required by 1 TAC §91.23.
Included in the proposed amendments to §1301.11 is the modification of
the definition of "Discharge" to clarify that an "inpatient" would be formally
released from the hospital. The Council proposes to amend the definition of
"Other health professional"by deleting "will encompass" and inserting "encompasses"
in the third sentence and including nurse practitioners, and nurse midwives
in the definition. These other health professionals are added to the "Other
health professional" list for individuals who should be allowed to review
and comment on patient data that may appear on a claim {transaction set}.
The Council also proposes to amend the definition of "Physician" in §1301.11
by deleting "(Article 4495b, Vernon's Texas Civil Statutes)." The Council
proposes to amend the definition "Required minimum data set" to clarify that
this is a list of data elements that are required to be submitted. Complementary
ANSI X12 Form 837 language is inserted for the following definitions to clarify
the terms "Batch," "Discharge claim," "Discharge file," "Error," "Required
minimum data set," "Submission," and "Submitter." The proposed amendments
expand the definition of "Public use data file" and "Uniform physician identifier."
Complementary ANSI X12 Form 837 language is included in the following subsections: §1301.12(a)
- (g); §1301.13(a); §1301.14(a) - (c); §1301.15(a); §1301.16(a),
(c) - (e); §1301.17 (a), (c); §1301.18 (d), (f), (i); §1301.20
(a), (c), (e) - (f).
The Council's enabling legislation found at Chapter 108 of the Health and
Safety Code directs the Council to collect and obligates hospitals to furnish
to the Council data for discharged inpatients attended or treated by physicians.
The Council is aware, however, that certain inpatients are attended and treated
by other health professionals as defined in §1301.11. The Council believes
that the costs of compliance with these sections will be reduced if hospitals
are afforded the opportunity, but not obligated, to submit data for discharged
inpatients who are attended or treated by other health professionals. Therefore,
when these sections impose a duty to submit discharge data or establish deadlines
for submitting discharge data, the duty or deadline applies solely to data
relating to discharged inpatients who are attended or treated by physicians.
The proposed amendments to §1301.12(a) describe the hospitals' duty to
submit data for discharged inpatients who are attended and treated by physicians
and afford hospitals the opportunity to report data for discharged inpatients
who are attended or treated by other health professionals.
The proposed amendment to §1301.12(a) provides that claims {transaction
sets} or consolidated claim {transaction sets} are to be submitted and allow
hospitals the option to submit data regarding the other health professionals
names and numbers on discharged inpatient claim data. New language is proposed
for §1301.12(b)(3) clarifying that when an inpatient has no third party
coverage and the hospital does not consolidate claims, then the hospital shall
submit the claims {transaction sets} as submitted to the payer. When the hospital
anticipates no payment, the hospital shall submit a separate claim {transaction
set} for each unit in which the patient was served. The proposed amendment
to §1301.12(b)(5) clarifies that "alcohol and substance abuse patients"
are the patients covered by 42 USC 290dd-2 and 42 CFR Part 2.1. The Council
proposes to amend 1301.12(c) to clarify that a letter exempting a hospital
from reporting electronically will come from the executive director.
The Council proposes to amend §1301.13(b) to limit the use of 1998
discharge data to test data and for the preparation of reports to the Council
members, governor and legislators. The proposed amendment to §1301.13(c)
extends the maximum number of days the executive director is authorized to
grant an extension to the submission deadline.
The proposed amendments to §1301.14(a)(2)(B) and §1301.14(c)(2)(B)
require the use of the three character Council assigned code for the facility
identifier to be included on the external identifications attached to the
tape or diskettes. The proposed amendments to §1301.14(a)(2)(G) and §1301.14(c)(2)(G)
insert "THCIC" before DISCHARGE DATA to clarify that the data submitted on
tape, diskettes or paper is for the purpose of fulfilling the Council's mandate.
The proposed amendments to §1301.14(b) remove as unnecessary the sentence
"Record length is 192 characters for all records" and add the requirement
that the Council furnish notifications in writing. The Council proposes to
amend the first sentence of §1301.14(c)(3) by deleting the word "filing"
and inserting the word "submitting" to maintain consistent language throughout
this title.
The Council proposes to amend §1301.15 (a)(1) to clarify the language
regarding the due date for submitting collected data when a hospital ceases
to be exempt. In subparagraph §1301.15(a)(2)(A) the Council proposes
to remove the assumption phrase "which will usually be daily, weekly or monthly."
A new paragraph three is proposed for §1301.15(a)(3) clarifying that
hospitals which have been granted authorization to submit more often than
once a quarter will certify data on a quarterly basis. The proposed amendment
to §1301.15(b)(1) establishes who is authorized to sign the exemption
request. The proposed amendments to §1301.15(b)(3)(B) and §1301.15(b)(4)(B)
provide for additional information to be used in making an appeal to the Council's
Board members.
The proposed amendment to §1301.16(c)(1) adds language requiring the
Council's executive director to establish policies and procedures for reviewing
discharge data. The proposed amendment to §1301.16(c)(2) establishes
30 calendar days from the date of receipt of a notification of errors as the
deadline for returning corrected data and clarifies that some inpatient discharge
data may not be able to be corrected. This data may be marked, using the Council's
data correction software, that it is as good as it can be. The proposed amendment
to §1301.16(c)(3) essentially reiterates §1301.16(c)(2) and clarifies
that data that has been edited, returned to hospital for certification and
was not certified maybe released. The proposed amendments to §1301.16(d)
provide for an annual review of the editing criteria relating to individual
data elements, in conjunction with the health information systems technical
advisory committee.
The proposed amendments to §1301.17(a) clarify that the Council will
return data, excluding certain data elements such as uniform patient identifiers,
uniform physician identifiers and other contractually prohibited data (for
example the 3M APR-DRG's, severity of illness and risk of mortality scores),
to hospitals for certification. Language is also added providing that the
electronic data will include other reports and additional information to assist
hospitals and their physicians in reviewing the data. The proposed amendments
to §1301.17(b) establish the requirement of responding to the certification
data and reiterate that the chief executive officer's designated agent may
sign the certification form. The proposal requires the Council's executive
director to determine the necessity and feasibility of data correction requests.
The proposed amendment establishes deadlines for the returning of data to
the Council or the Council's agent. Language is added to establish a procedure
for additional discharges not previously submitted and data corrections received
after the deadline and provides for corrected data received from authorized
hospitals to be included in a supplemental file in conjunction with the next
scheduled release of the public use data file. Data corrections received after
the deadline from hospitals that have not received approval by the executive
director will not be published. The Council will not include discharges in
the supplemental discharge file that occurred before the quarter preceding
the quarter currently being certified. The proposed amendment to §1301.17(c)
clarifies ambiguities regarding the hospital discharge report certification
process and establishes that the other health professionals may write comments
and any errors that are brought to the attention of the chief executive officer
or the officer's designee. The Council proposes a new subsection to §1301.17(d)
which requires the executive director to provide to hospitals a second file
containing un-edited data for the purpose of reviewing all the data elements
that may be requested under §1301.18(m) of this title. The proposed amendment
to §1301.17(d) to be renumbered to (e) adds language clarifying the due
dates for the certification form and the end of the reporting quarter. An
exemption process is proposed by which the Council may grant exemptions to
hospitals from certifying data and providing that the exempted hospital's
uncertified data will not be released in a public use data file. The Council
proposes to renumber subsection §1301.17(e) to (f). The proposed amendment
to §1301.17(f) to be renumbered to (g) provides that failing to return
the certification form by the due date is punishable by civil penalty.
The proposed amendments to §1301.18(a) clarify that only the public
use data file will be available at the Council for public inspection and the
original discharge claims are not available. The proposed amendment to §1301.18(b)
changes the number of paragraphs from four to two for the subsection because
of the proposed removal of paragraphs (2) and (3). The Council proposes deleting §1301.18(b)(2)
which requires the executive director to establish a process to assign geographic
identifiers to the public use data file. This proposal is in response to the
passage of House Bill 1513 which changed the language regarding the release
of and access to a patient's ZIP code in Health and Safety Code §108.013(c)(1).
The Council also proposes deleting §1301.18(b)(3) to remove the requirement
to create a uniform payer identifier. The proposed amendment to §1301.18(c)
provides for an annual review of the data elements to be included in the public
use data file. The Council proposes a new subsection (c)(1) to §1301.18
which provides a list of the data elements that shall be released with each
public use data file. The proposed amendment to §1301.18 (c)(1) renumbered
to §1301.18(c)(2) removes the uniform patient identifier, county code
assignment and the patient's date of birth and clarifies that the patient's
name and the insured's name shall be removed from the public use data file.
The Council proposes deleting the requirement to convert payer names and numbers
to a uniform payer identifier and insert the requirement to attach the comments
submitted by hospitals and physicians in §1301.18(c)(7). The Council
proposes to amend §1301.18(c)(13) which establishes that policies and
procedures are to be in place to remove uniform physician identifiers that
may potentially identify physicians in certain situations. The Council is
requesting comments on this paragraph. The proposed amendment to §1301.18(e)
establishes a "no later than" date for release of the public use data file.
The proposed amendments to §1301.18(e)(1) require the Council's executive
director to develop policies and procedures for use in evaluating whether
discharge encounters that have known errors and should be excluded from the
public use data file. The proposed amendment to §1301.18(e)(2) establishes
that discharge claims {transaction sets} that have not been submitted from
one previous reporting quarter may be submitted and will be made available
to the public in a supplemental file. The proposed amendments to §1301.18(e)(3)
establishes data on patients discharged in1998 will be used for testing, calibrating
and providing reports to Council members, governor and the legislature. The
proposed amendments to §1301.18(e)(4) establish first and second quarter1999
as the first data to be released in a public use data file. The proposed amendment
to §1301.18(f) capitalizes the word "state" that occurs in the first
sentence. The proposed amendment to §1301.18(j) requires the Council's
executive director to post a summary of requests for discharge data on the
Council's Internet site and publish the list of names in the next numbered
letter published after the request and when public use discharge data for
a specific hospital is requested the executive director is required to notify
the affected hospital. The proposed amendment to §1301.18(k) provides
that the Council's executive director will attach corresponding reporting
quarters' comments with the release of public use data file and research file
or any report prepared by the Council. The Council proposes a new subsection §1301.18(l)
that requires the Council to review of the public use data elements with the
assistance of the health information systems technical advisory committee.
The proposed new subsection §1301.18 (m) establishes that the Council
shall establish guidelines for data security and confidentiality regarding
the release of data by the Council. The Council proposes a new subsection §1301.18(n)
to establish criteria for releasing data that are not required to be certified
by the hospitals. These new subsections are proposed in response to the passage
of HB 1513.
New §1301.19 establishes the Scientific Review Panel. The proposed
subsections establish membership, meetings, guidelines for decision making
and reports to the Council.
The proposed changes under old §1301.19(a)(1) new §1301.20(a)(1)
provide that the Council will accept versions 006.0 and 005.0 of the HCFA
UB-92 electronic file format and will follow the HCFA guidelines when only
one version is acceptable to HCFA. The proposed changes to old §1301.19(a)(2)
new §1301.20(a)(2) correct a misspelling in the first sentence, the latest
approved version of the American National Standards Institute (ANSI) X12N
form 837 from 30.70 to 40.10 and provide that the Council will follow the
HCFA guidelines when only one version is acceptable to HCFA. The proposed
change to old §1301.19(a)(3) new §1301.20(a)(3) emphasizes that
HCFA 1450 paper versions are only acceptable when approved by the Council's
executive director. The proposed change to old §1301.19(c)(4)(A) and
(B) new §1301.20(c)(4)(A) and (B) adds "UB92" to clarify that the acceptable
standard source of payment codes are acceptable with data submitted in the
HCFA UB92 Electronic Format or HCFA 1450 paper forms and requires that secondary
and tertiary non-standard source of payment codes be submitted on corresponding
sequence number "22" Records. The Council recommends that data reported in
HCFA UB92 Fields 4, 5, 6, 7 and 8 on the "22" Record also be filled with the
same information as reported in the first "22" Record (sequence 01). The proposed
change to old §1301.19(c)(4)(A)(viii) new §1301.20(c)(4)(A)(viii)
capitalizes the acronym of Civilian Health and Medical Program of the Uniformed
Services - CHAMPUS. The Council proposed a new subparagraph to old §1301.19(c)(4)(C)
new §1301.20(c)(4)(C) that establishes acceptable claim filing indicator
codes for ANSI X12N Form 837 Electronic Format. The Council proposes changes
to old §1301.19(e)(12) new §1301.20(e)(12) to add "non-standard"
source of payment codes to the required minimum data set. The proposed changes
to old §1301.19(e)(39)-(41) new §1301.20(e)(39)-(41) clarify that
either the HCFA UPIN or the State license number is required on the required
minimum data set. The Council proposes changes to old §1301.19(e)(42)-(44)
new §1301.20(e)(42)-(44) to clarify that the physician's name or other
health professional's name should be reported as HCFA or the appropriate state
licensing boards list their names. The proposed change to old §1301.19(f)
new §1301.20(f) emphasizes that alcohol and substance abuse patients
are the patients who are covered by 42 USC 290dd-2 and 42 CFR Part 2.1. The
proposed change to old §1301.19(g) new §1301.20(g) updates the rule
to a current version of the UB-92 electronic format for the data elements
listed in §1301.20 (g)(1) through (13).
THA'S COMMENTS AND COUNCIL'S RESPONSES
§1301.12(b)(3)
The commenter recommended the removal of skilled nursing facility (SNF)
inpatient data from the public use data file and the flagging of patients
who were served in other specialty units. The Council disagrees with removing
SNF inpatient data from the public use data file because these patients will
also be flagged as required in §1301.18(c)(12). The relative lengths
of stays for each specialty unit the patient was served in will be indicated
on the public use data file with a maximum of five specialty units.
§1301.12(b)(4)
The commenter recommended an amendment to §1301.12(b)(4), to reduce
the reporting requirements to the minimum data set as specified in §1301.20(e).
The Council agrees that moving to a state specified data set would facilitate
hospitals in reporting their inpatient data. The Council disagrees with making
this amendment at this time in the final development stages of health care
data collection system. The Council believes that such a change will create
a burden on the hospitals to change their reporting requirements at this late
date. The Council recognizes that the required data elements specified in §1301.20(e)
will be the primary data elements analyzed in the public use data file, but
the other data elements reported, for example; condition, value and occurrence
codes have analytical and statistical value for research studies involving
the payers and consumer groups. The Council will continue to look at and discuss
the practicality of going to a specified data set.
§1301.13(b)
The commenter proposed limiting the data collected from calendar year 1998
for test and certification purposes. The Council agrees and proposes new language
to limit the use of the 1998 data for testing purposes, to produce reports
for the Council's meetings, and for reports to the governor and legislature
regarding the status of the statewide health care data collection system.
§1301.13(c)
The commenter recommended an amendment to extend from ten days to thirty
working days the maximum number of days that the executive director could
have to grant an extension to processing due dates, stating that ten working
days do not provide enough time to meet the due dates with certain situations,
such as computer failures. The Council agrees that ten working days may not
be adequate for certain situations, but disagrees that the maximum length
of time should be thirty working days. Computer failures should have proper
backup systems. The Council proposes that the executive director be authorized
to grant a maximum twenty-one calendar day extension to processing due dates.
The 21 day time period coincides with the maximum allowable time for corrections
of the discharge encounter data that is returned for certification.
§1301.14(a)(2)
The commenter recommended that no limitations be established on the number
of tapes or diskettes per submission. The Council disagrees. The Council's
rule allowing submission by tapes and diskettes is intended to assist smaller
hospitals. The Council expects larger hospitals to transmit transaction sets
by electronic data interchange (modem) or to have a vendor do it for them.
The Council strongly encourages large scale data submissions to be by modem.
§1301.15(a)(1)
The commenter recommended an increase from 30 to 90 days for hospitals
that lose their reporting exemption status before the hospitals are responsible
for collecting discharge data and to allow them at least 180 days to submit
their first initial discharge file after the loss of their exempt status.
The Council agrees with increasing the number of days to 90 calendar days
between the loss of exempt status notice and the date the hospital is responsible
for submitting data. The Council disagrees with establishing the number of
days after notice until the first initial submission to be greater than 180
days. The Council has established rules and guidelines that closely track
HCFA for reporting claims {transaction sets}. Approximately 40 percent of
claims in Texas are Medicare related; thus the Council assumes that the hospital
would have systems in place to submit claims to Medicare. The Council proposes
to require hospitals to submit their initial discharge data claims {transaction
sets} the first due date as specified in §1301.13(a) for the data collected
in the reporting quarter that occurs 90 days after the date the loss of exemption
is given.
§1301.15(b)(3)(B) and (b)(4)(B)
The commenter proposed language to §1301.15(b)(3)(B) and (b)(4)(B)
to allow additional information to be presented during an appeal of the Council's
executive directors decision, regarding exempt status of a hospital, to the
Council board members. The Council agrees with the proposed language and has
incorporated it in the proposed amendments.
§1301.16(b)
The commenter recommended new language for the third sentence of §1301.16(b)
to increase from 10 to 14 the number of working days the hospital is allowed
to correct and return data. The Council disagrees. This section deals only
with improper media, physically damaged media or problems with the file structure
of the submission. These are errors that would be corrected by the hospital
generating and re-sending a replacement file. This would normally be done
in a few days from the data used to prepare the original files, batches and
claims {communications envelope and interchange envelopes, functional groups
and transaction sets}.
§1301.16(c)(2)
The commenter stated that the language in §1301.16(c)(2) is confusing
and proposed the following language: "Within 30 days of receiving initial
notice of errors in a discharge report, the hospital shall correct all discharge
files containing errors, add any discharge files determined to be missing
from the initial discharge report and resubmit any or all discharge files."
The Council agrees with the intent of the proposed language and has proposed
language to allow a hospital to submit complete and corrected files, batches
and claims {communications envelope and interchange envelopes, functional
groups and transaction sets}. The proposed amendment provides several options
for correcting data, including the use of the data correction software provided
by the Council. The current correction pathways follow: 1) The hospital can
submit claims {transaction sets} with adjustment or replacement bill type
codes (e.g. XX6 (Adjustment) or XX7(Replacement Claim)). 2) The hospital can
submit files, batches and all individual claims {communications envelope and
interchange envelopes, functional groups and all transaction sets} for a selected
time frame utilizing XX8 (Void/Cancel previous claim) and then resubmit the
corrected data using original bill types. The hospital may elect to submit
XX8 claims, then corrected original (XX0, XX1, XX2, XX3, XX4, or XX5) claims
for only the errant claims {transaction sets}. 3) Hospitals have the option
of utilizing the Council supplied data correction software to make corrections,
delete errant claims {transaction sets} or mark individual claims as "accept
as is"when the hospital cannot correct the claim due to circumstances in which
the data cannot be obtained. 4) Hospitals that cannot submit adjustment (XX6),
replacement (XX7) or Void/Cancel (XX8) claims and are not using the Council's
data correction software will need to contact the Council and request to contract
with the Council's agent (there is a cost to the hospital associated with
this process) to have the files, batches or claims {communications envelope
and interchange envelopes, functional groups and transaction sets} with errors
deleted. After the errors are deleted, the correct claims can be submitted
and processed. Hospitals that have numerous errors or errors on each claim
{transaction set} may elect to use the latter method. Hospitals that do not
delete errant claims or have claims deleted and submit corrected claims {transaction
sets} with the original bill types will be marked as duplicate claims {transaction
sets} and the encounter data will not be corrected, but will be processed
and checked for errors. The adjustment, replacement and void/cancel claims
{transaction sets} will be merged at the time the Council creates the certification
files and other review files.
§1301.16(e)
The commenter recommended new language for §1301.16(e) so that hospitals
would be required to correct discharge claims {transaction sets} to a substantial
level of accuracy prior to the deadline for making corrections, stating concerns
of possible fraud allegations. The commenter states that the hospitals must
submit one response for Medicare and a different response for the Council.
The Council disagrees. The commenter's recommended language is subjective
and not enforceable. The Council has established its reporting requirements
using the United States Department of Health and Human Service, Health Care
Financing Administration's guidelines, and the data corresponds.
§1301.17(b)
The commenter suggested adding the word "substantially" prior to accurate
in the first sentence of §1301.17(b). The Council disagrees with using
the word "substantially" because the word is too subjective and would not
be legally enforceable. The language of §1301.17(b) has been modified
to state that the hospital's chief executive officer (CEO) or the designee
must respond to and sign a form supplied by the Council regarding the accuracy
of the data. For example, if the chief executive officer elects not to certify
the encounter data because the CEO has evidence that the data does not accurately
represent the inpatient data history of the hospital, then the CEO is required
to indicate on the form supplied by the Council that the CEO or the CEO's
designated agent do not certify the data. The CEO or the CEO's designated
agent must also submit a written explanation regarding the errors and how
the hospital anticipates correcting them. The form should be signed by the
CEO or the CEO's designated agent and a facsimile communication delivered
to the Council by the deadlines specified in §1301.17(e) of the proposed
amended rules. Error corrections so noted by the hospital are then due to
the Council by the deadlines specified in §1301.17(b).
§1301.17(c)
The commenter recommended an amendment of the first sentence of §1301.17(c)
to include the phrase "substantially accurate." The Council disagrees. The
phrase is subjective and is not legally enforceable. The language in §1301.17(c)
has been modified to emphasize on the signed certification form that the data
submitted to THCIC accurately represents the hospital's administrative status
of discharged inpatients for the quarter. The commenter suggested that the
words "admitting" and "treating" have different meanings to different hospitals.
The Council agrees and has proposed an amendment deleting "admitting" and
inserting "attending." Definitions for "attending physician" and "treating
physician" have been added in §1301.11 of this title.
§1301.17(d)(relettered to (e))
The commenter recommended that hospitals should not be required to certify
data that is more than six months old. The Council disagrees because by the
time the certification is due, the data will be eight months old. The Council
has proposed language to provide the Council the opportunity to exempt one
or more hospitals from the requirements of certifying the data as specified
in §1301.17(e). Data from hospitals that are granted an exemption from
the certification process shall not be released in a public use data file.
§1301.18(e)(3)
The commenter recommended the inclusion of all 1998 discharge data as test
data. The Council agrees and has proposed language to exclude the 1998 data
from a public use data file. The Council will use the data to produce reports
to the Council members, the governor and legislators as needed to provide
information about the status and capabilities of the health care data collection
system.
Old §1301.19(b)
The commenter recommended an amendment that would require the Council to
publish the dates on which specifications were posted, when they would become
effective, and the period of data that would be affected. The Council agrees
and has included the language as proposed.
Jim Loyd, Executive Director, has determined that for the first five-year
period the proposed sections are in effect, there will be no additional costs
associated with administering or enforcing the sections as amended for establishing
selected data elements for the public use data file or for receiving secondary
and tertiary "non-standard source of payment codes." However, there is an
estimated cost of reviewing and deleting data that are below the required
minimum cell size criteria as established in §1301.18 and a cost for
providing travel reimbursement for the Scientific Review Panel (SRP) members.
The cost is anticipated to be less than $3,940 for each year of the first
five years. The value is based on an estimated annual cost of $1,100 derived
from an expected maximum number of 300 report pages per year with a maximum
of five fields below the minimum cell size criteria; average of 10 minutes
per page to review cells and a maximum of 2 minutes per cell to delete and
mark reports, using $22 as the average hourly salary of Council staff members
who would perform the function. An estimated cost of $1,440 for staff time
to evaluate research proposals, compile make copies of proposals, and disseminate
information to SRP members, then coordinate the arrangements for the SRP meetings
and provide support for the meeting, are eighty person hours at an average
hourly salary ($18) of the Council staff personnel involved with these duties.
The yearly estimated cost of reimbursement for SRP members is anticipated
to not exceed $8,400, and this amount is based on the average travel reimbursement
per trip of the Council's board members ($200) times the (maximum of seven)
of SRP members times an estimate six trips a year.
Mr. Loyd has also determined that for the first five-year period the proposed
sections are in effect there, will be no anticipated costs to most local government
affected by as a result of enforcing or administering the new amended sections.
There are anticipated costs for local governments that do own hospitals or
hospital districts and are required to report data to the Council. The Council
anticipates that the requirement of submitting a "22" Record, Field 09 "non-standard
source of payment codes" that correspond to the "30" Record, Field 04 "Standard
source of payment codes" for the secondary and tertiary payers, as specified
by §1301.20(c)(4), would have an initial cost and a recurring cost for
each claim submitted. The initial cost is dependent upon each hospital's information
systems capabilities and their staff resources. Based on previous changes
to data extract systems, the anticipated maximum cost would be no more than
$15,000 for some hospitals (several hospitals that are using a vendor to assist
them in their data collection and submission efforts have report charges up
to $10,000 for making changes to their data extract system) and there would
be no additional costs for some hospitals that already submit the corresponding
"22" Record information, regarding "non-standard source of payment codes."
The University of Texas, M.D. Anderson Cancer Center estimated of $2,500 to
make the initial change to their system. Texas State Hospitals estimates $25,000
(for 10 hospitals) to make the initial change to their systems. The University
of Texas, Medical Branch Hospital at Galveston estimates no additional costs
are anticipated to make the initial change to their systems. South Texas Hospital
estimates $2,600 to make the initial change to their systems. Texas Center
for Infectious Disease estimates no additional costs are anticipated to make
the initial change to their systems. The University of Texas, Health Center
in Tyler estimates no additional costs are anticipated to make the initial
change to their systems. Harris County Psychiatric Hospital estimates $2,500
as the cost to make the initial change to their systems. The Council anticipates
that the additional recurring costs for submitting this information would
not be greater than four cents per claim for some hospitals and some hospital
would have no additional recurring costs since they have already provided
this information. The University of Texas, M.D. Anderson Cancer Center estimates
no additional costs are anticipated for recurring costs with their system.
Texas State Hospitals estimates no additional costs are anticipated for recurring
costs with their systems. The University of Texas, Medical Branch Hospital
at Galveston estimates no additional costs are anticipated for recurring costs
with their systems. South Texas Hospital estimates no additional costs are
anticipated for recurring costs with their systems. Texas Center for Infectious
Disease estimates no additional costs are anticipated for recurring costs
with their systems. The University of Texas, Health Center in Tyler estimates
no additional costs are anticipated for recurring costs with their systems.
Harris County Psychiatric Hospital estimates no additional costs are anticipated
for recurring costs with their systems. There are no foreseeable fiscal implications
relating to revenues of the other state or local governments as a result of
enforcing or administering the other new sections.
Mr. Loyd also has determined that for each year of the first five-year
period the proposed sections are in effect the public benefit anticipated
will be clearly defined set of data elements to be released in the public
use data file, clarified language regarding certification of data, more detailed
payer source code information, and established guidelines for releasing non-certified
data. Mr. Loyd estimates that there will be anticipated costs to providers
as a result of enforcing or administering the new sections or to small businesses
that own hospitals. The Council anticipates that the requirement of submitting
a "22" Record, Field 09 "non-standard source of payment codes" that correspond
to the "30" Record, Field 04 "Standard source of payment codes" for the secondary
and tertiary payers, as specified by §1301.20(c)(4), would have an initial
cost and a recurring cost for each claim submitted. The initial cost is dependent
upon each hospital's information systems capabilities and their staff resources.
Based on previous changes to data extract systems, the anticipated maximum
cost would be no more than $15,000 for some hospitals (several hospitals that
are using a vendor to assist them in their data collection and submission
efforts have report charges up to $10,000 for making changes to their data
extract system) and there would be no additional costs for some hospitals
that already submit the corresponding "22" Record information, regarding "non-standard
source of payment codes." The Council anticipates that the additional recurring
costs for submitting this information would not be greater than 4 cents per
claim for some hospitals and some hospital would have no additional recurring
costs since they have already provided this information.
Comments on the proposed sections may be submitted to Jim Loyd, Executive
Director, Texas Health Care Information Council, Brown-Heatly Building, 4900
North Lamar, Suite 3407, Austin, Texas 78751-2399 no later than 30 calendar
days from the date that these proposed sections are published in the
25 TAC §§1301.11 - 1301.18
The amendments are proposed under the Health and Safety Code, §§108.006
and 108.009. The Council interprets §108.006 as authorizing it to adopt
rules necessary to carry out Chapter 108, including rules concerning data
dissemination requirements. The Council interprets §108.009 as authorizing
the Council to adopt rules regarding the collection of data from hospitals
in uniform submission formats to make the incoming data substantially valid,
consistent, compatible and manageable.
The Health and Safety Code, §§108.006, 108.009, 108.010, 108.011
and 108.012 are affected by these proposed amendments and new section.
§1301.11.Definitions.
The following words and terms, when used in this chapter, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Attending Physician - The individual licensed
under the Medical Practice Act (Occupations Code, Chapter 151) primarily responsible
for the care of the patient from the beginning of the hospital episode. For
Skilled Nursing Facility (SNF) services,(that is, swing bed), the attending
physician is the individual who certifies the SNF plan of care.
(2)
[
(3)
Certification-- Confirmation by a
hospital of the accuracy and completeness of the data set required to produce
the public use data file.
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
Discharge Encounter--A representation
of a patient's billing information for their hospital stay from admission
through discharge. This could be a single patient bill representing admission
through discharge, or a consolidated bill comprised of multiple bills which
could include one or more of the following bill types: "Replacement Bills",
"Adjustment Bills", "Late Charges", "Zero Charge Bills" or "Interim Bills".
(10)
[
(11)
Edit--An electronic standardized
process developed and implemented by the Council to identify potential errors
and mistakes in data elements by reviewing data fields for the presence or
absence of data and the accuracy and appropriateness of data.
(12)
[
(13)
[
(14)
[
(15)
[
[
[
(16)
[
(17)
[
(18)
ICD-International Classification
of Disease.
(19)
[
(20)
[
(21)
[
(22)
[
(23)
[
(24)
[
(25)
Provider quality data --A report
or reports regarding providers created from data collected by the Council
or obtained from other resources.
(26)
[
(27)
[
(28)
Research data file--A data file that
includes the public use data elements and additional data elements collected
by providers. The research data file shall not include any patient or physician
identifying information (e.g., Last Name, First Name, Middle Initial, Patient
Address, Date of Birth, and Social Security Number, Claim Certificate Identification
Number). The additional data elements shall include but is not limited to
all uniform patient and physician identifiers, revenue codes, revenue code
charges, actual dates of service, occurrence codes, occurrence dates, value
codes and revenue code. These additional data elements are subject to release
to a requestor who complies with the requirements specified in §1301.18(n)
of this title (relating to Hospital Discharge Data Release).
(29)
[
(30)
[
(31)
[
(32)
Scientific Review Panel - Council
appointees who have experience and expertise in ethics, patient confidentiality,
and health care data who review and approve or disapprove requests for information
other than the public use data file.
(33)
[
(34)
[
(35)
[
(36)
Treating Physician -The person licensed
under the Medical Practice Act who has treated the patient or who has consulted
on the patient's case. The term includes any physician listed on the claim
{transaction set} other than the attending physician.
(37)
[
(38)
[
(39)
[
[
(40)
[
(41)
Validation--The process by which
a provider verifies the accuracy and completeness of data and corrects any
errors identified before certification.
§1301.12.Collection of Hospital Discharge Data.
(a)
All hospitals in operation for all or any
part
of the reporting periods described in §1301.13 of this title (relating
to Schedule for
Submitting
[
(b)
All inpatient discharges shall be reported. Except as noted
in paragraphs (1) - (5) of this subsection, one or more discharge
claims
{transaction sets}
[
(1)
Separate discharge
claims {transaction sets}
[
(2)
Hospitals shall either submit separate discharge
claims {transaction sets}
[
(3)
Where
an inpatient
[
(4)
For all
discharged inpatients
[
(5)
For all
alcohol and substance abuse
patients
who
[
(c)
All hospitals shall
submit
[
(d)
All hospitals shall submit discharge
claims {transaction
sets}, batches {functional groups) and discharge files {communications envelopes
and interchange envelopes}
[
(e)
Hospitals shall submit discharge
files {communications
envelopes and interchange envelopes}
, [
(f)
Hospitals may submit discharge
files {communications
envelopes and interchange envelopes}
, [
(g)
If requested by the Council, a hospital shall provide the
executive director or the director's agent, the Texas Department of Health,
access to, copies of and/or information from the hospital documents and records
underlying and documenting the discharge
file {communications envelopes
and interchange envelopes}
[
§1301.13.Schedule for Submitting [
(a)
For discharges occurring on or after January 1, 1998, hospitals
shall
submit
[
(1)
Each discharge
claim {transaction set}
[
(2)
Each discharge
claim {transaction set}
[
(3)
Each discharge
claim {transaction set}
[
(4)
Each discharge
claim {transaction set}
[
(b)
[
(c)
Extensions to processing due dates may be granted by the
executive director for a maximum of
21 calendar
[
(d)
Failure to
submit
[
§1301.14.Instructions for Submitting [
(a)
Magnetic Media. A discharge
file
[
(1)
Media specifications are:
(A)
Diskette: MS-DOS formatted; PC Text file (ASCII); Record
length = 192 characters, fixed; 3.5 inch diskette, 1.4 megabyte, high density.
(B)
Nine track tape: Density = 1600 or 6250 BPI, nine track;
Collating sequence = EBCDIC; Record length = 192 characters, fixed; Blocking
= blocked (170 records per block recommended; 40 records per block minimum);
Labeling = IBM standard or facsimile.
(C)
Other magnetic media: Discharge
files
[
(2)
Hospitals shall submit no more than one tape
or two diskettes per submission, with the following external identification
affixed as listed in subparagraphs (A)-(G) of this paragraph:
(A)
hospital name;
(B)
facility identifier
(THCIC Code)
;
(C)
reporting period for discharges;
(D)
number of records by record type;
(E)
tape density: 1600/6250 BPI (if applicable);
(F)
collating sequence for tapes (if applicable);
(G)
the description: "
THCIC
DISCHARGE DATA."
(3)
Data for more than one hospital may be submitted
on a single tape if the submitter provides external identification items (A)
through (D) for each hospital.
(4)
In addition to the provisions of this section, the
Council shall document instructions for
submitting
[
(b)
Electronic Data Interchange. Discharge
files
[
(c)
Paper Forms. Only hospitals granted an exemption from electronic
submitting
[
(1)
All UB-92 forms filed shall be on the form currently approved
by the federal Health Care Finance Administration. Photocopies are not acceptable.
(2)
Hospitals shall submit no more than one batch of paper
forms per submission, with the following external identification affixed as
listed in subparagraphs (A)-(E) of this paragraph:
(A)
hospital name;
(B)
facility identifier;
(THCIC Code);
(C)
reporting period for discharges;
(D)
number of forms; and
(E)
the description:
"THCIC
DISCHARGE DATA."
(3)
In addition to the provisions of this section,
the Council shall document instructions for
submitting
[
§1301.15.Exemptions from Submitting [
(a)
Types of Exemptions.
(1)
Exemption as a rural provider or other exempted provider.
All hospitals except those owned by the federal government shall submit discharge
files {communications envelopes and interchange envelopes}
[
(2)
Exemptions from Quarterly
Submission
[
(A)
The exemption request includes the specific schedule on
which the hospital will make its discharge
files {communications envelopes
and interchange envelopes}
[
(B)
The exemption request states the medium in which submissions
will be made.
(C)
The exemption request will not result in data on any discharge
being submitted to the Council at a later date than it would have been if
the standard schedule had been followed.
(D)
The hospital agrees to adhere to the schedule specified
in the exemption request until the hospital notifies the executive director
in writing that it wishes to end the exemption and report according to the
standard schedule, or until a new exemption letter is issued.
(3)
Hospitals that are approved for
submitting discharge files {communications envelopes and interchange envelopes}
more often than quarterly shall certify data as specified in §1301.17
of this title (relating to Certification of Discharge Data).
(4)
[
(5)
[
(b)
Requests for exemptions shall be submitted and processed
using the following procedures as shown in paragraphs (1)-(4) of this subsection.
(1)
A hospital requesting an exemption shall submit to the
executive director a letter requesting the exemption and providing all information
necessary to establish the hospital's entitlement to the exemption. The exemption
request shall be signed by the
hospital's
chief executive officer
or the chief executive officer's designated agent
[
(2)
The executive director shall review the request for
exemption. The executive director may request additional information from
the hospital relevant to the exemption request. Within 30
calendar
days of receipt of a request, the executive director shall issue a letter
granting or denying the exemption. If denied, the letter shall state in detail
the reasons for the denial. The executive director shall notify Council members
of exemptions requested and the disposition of these requests for information
only.
(3)
If the executive director denies an exemption request
the hospital may:
(A)
resubmit the request along with any additional information
or analysis the hospital deems relevant to the executive director. The resubmission
shall be considered in the same manner as an initial submission; or
(B)
appeal the executive director's decision to the Council.
The hospital may make an appeal directly to the Council. In making its determination,
the Council will consider
any information and analysis provided by the
hospital and the executive director
[
(4)
The executive director may revoke any type of
exemption if facts indicate that a hospital no longer meets the criteria required
for an exemption. The executive director shall give the hospital written notice
of the revocation at least 30
calendar
days prior to the effective
date of the revocation. The notice shall include a detailed statement of the
facts on which the revocation is based. A hospital may challenge the revocation
of its exemption by:
(A)
requesting the executive director to reconsider the revocation
by submitting any information or analysis the hospital deems relevant to the
executive director in writing at least ten
calendar
days prior
to the effective date of the revocation; and
(B)
by appealing to the Council if the executive director does
not grant the request for reconsideration. In making its determination, the
Council will consider
any information and analysis provided by the hospital
and the executive director
[
(c)
Reporting loss of exemptions. Hospitals shall notify the
executive director in writing within 30
calendar
days of their
loss of an entitlement to an exemption authorized by subsection (a) of this
section.
§1301.16.Acceptance of Discharge Files [
(a)
To verify the accuracy of all discharge
claims {transaction
sets}
[
(b)
Upon receipt of a discharge
file
, [
(1)
The physical media and labeling do not conform to the specifications
in §1301.14 of this title (relating to Instructions for [
(2)
The physical media are unreadable due to physical
damage.
(3)
The file structure does not conform to the specifications
in
§1301.20
[
(c)
Correction of Errors.
(1)
The executive director shall
establish policies and
procedures to
review all discharge
files, batches and claims {communications
envelope and interchange envelopes, functional groups and transaction sets}
[
(2)
Within 30
calendar
days of receiving
the
initial notice of errors [
(3)
Within ten
calendar
days of receiving corrections
to a discharge
claim {transaction set}
[
(d)
The executive director will document and the Council will
approve all acceptance and editing criteria utilized in reviewing discharge
[
(e)
Failure to correct a discharge
claim {transaction
set}
[
§1301.17.Certification of Discharge Encounter Data [
(a)
Within
four months
[
(b)
The chief executive officer of each hospital shall
respond to statements on the form, sign and return the certification form
corresponding to
[
(c)
The
signed
certification
form
shall
represent that
:
[
(1)
policies and procedures are in place within
the hospital's processes to validate and
assure the accuracy of the
discharge
encounter data
[
(2)
all errors and omissions known to the
hospital have been corrected
;
[
(3)
to the best of their knowledge and belief,
the data submitted
accurately represents the hospital's administrative
status of discharged patients for the reporting quarter;
[
(4)
the hospital has provided physicians and
other health professionals [
(d)
The executive director shall provide to
the hospital an additional review file or files to accompany the file or files
to be certified. The review file or files shall contain other data elements
submitted by the hospital that are not required to be certified. The review
file or files may be used by the hospital for its review of submitted data
which are available through requests made under §1301.18(n) of this title
(relating to Hospital Discharge Data Release).
(e)
[
(f)
[
(g)
[
§1301.18.Hospital Discharge Data Release.
(a)
Council records are public records under Government Code,
Chapter 552, except as specifically exempted by Health and Safety Code, §108.010
and §108.013[
(b)
Creation of codes and identifiers. The executive director
shall develop the following codes and identifiers, as listed in paragraphs
(1)-
(2)
[
(1)
The executive director shall create a process for assigning
uniform patient identifiers, uniform physician identifiers and uniform other
health professional identifiers using data elements collected. This process
is confidential and not subject to public disclosure. Any documents or records
produced describing the process or disclosing the person associated with
an identifier are confidential and not subject to public disclosure.
[
[
(2)
[
(c)
Creation of public use data file.
The executive director
shall establish a public use file data element list (specified in paragraph
(1) of this subsection) and the Council with the assistance of the advisory
committee described in Health and Safety Code, §108.003(g)(5) shall review
the list annually.
The executive director will create a public use data
file by creating a single [
(1)
data elements to be included in the public
use data file:
(A)
Provider Name (Facility Name)
(B)
Patient Sex/Gender
(C)
Type of Admission
(D)
Source of Admission
(E)
Patient ZIP (5-digits)
(F)
Patient State
(G)
Patient Status
(H)
Patient Race
(I)
Patient Ethnicity
(J)
Source of Payment Code, Non-Standard Codes (Keep
first two records, if submitted)
(K)
Source of Payment Code, Standard Codes (Keep
first two records)
(L)
Type of Bill
(M)
Encounter Indicator
(N)
Principal Diagnosis Code (Current version of
ICD codes at the time data is submitted)
(O)
Other Diagnosis Codes (1)(Current version of
ICD codes at the time data is submitted)
(P)
Other Diagnosis Codes (2)(Current version of
ICD codes at the time data is submitted)
(Q)
Other Diagnosis Codes (3)(Current version of
ICD codes at the time data is submitted)
(R)
Other Diagnosis Codes (4)(Current version of
ICD codes at the time data is submitted)
(S)
Other Diagnosis Codes (5)(Current version of
ICD codes at the time data is submitted)
(T)
Other Diagnosis Codes (6)(Current version of
ICD codes at the time data is submitted)
(U)
Other Diagnosis Codes (7)(Current version of
ICD codes at the time data is submitted)
(V)
Other Diagnosis Codes (8)(Current version of
ICD codes at the time data is submitted)
(W)
Principal Procedure code (if applicable )(Current
version of ICD codes at the time data is submitted)
(X)
Other Procedure code (1)(Current version of
ICD codes at the time data is submitted)
(Y)
Other Procedure code (2)(Current version of
ICD codes at the time data is submitted)
(Z)
Other Procedure code (3)(Current version of
ICD codes at the time data is submitted)
(AA)
Other Procedure code (4)(Current version of
ICD codes at the time data is submitted)
(BB)
Other Procedure code (5)(Current version of
ICD codes at the time data is submitted)
(CC)
Admitting Diagnosis (Current version of ICD
codes at the time data is submitted)
(DD)
External Cause of Injury (if applicable)(Current
version of ICD codes at the time data is submitted)
(EE)
Day of Week Patient is admitted code (Sun.
= 1, Mon. = 2, Tues. = 3, Wed. = 4, Thur. = 5, Fri. = 6, Sat. = 7 )
(FF)
Length of Stay (Statement Covers Period Through
- Admission/Start of Care Date)
(GG)
Age of patient in years at date of discharge
(Statement Covers Period Through date minus Patient Birth Date)
(HH)
Encounter Indicator: This indicates whether
more than one claim {transaction set} was used to create the encounter
(II)
Day number of Principal Procedure (Calculated
Principal Procedure Date minus Admission/Start of Care Date)
(JJ)
Day number of Procedure (1) (Calculated Procedure
Date (1) minus Admission/Start of Care Date)
(KK)
Day number of Procedure (2) (Calculated Procedure
Date (2) minus Admission/Start of Care Date)
(LL)
Day number of Procedure (3) (Calculated Procedure
Date (3) minus Admission/Start of Care Date)
(MM)
Day number of Procedure (4) (Calculated Procedure
Date (4) minus Admission/Start of Care Date)
(NN)
Day number of Procedure (5) (Calculated Procedure
Date (5) minus Admission/Start of Care Date)
(OO)
HCFA-DRG Code (Obtained from the 3M HCFA-DRG
Grouper)
(PP)
APR-DRG Code (Obtained from 3M APR-DRG Grouper)
(QQ)
Risk of Mortality Score (Obtained from 3M
APR-DRG Grouper)
(RR)
Severity of Illness Score (Obtained from 3M
APR-DRG Grouper)
(SS)
Uniform Physician Identifier assigned to Attending
Physician
(TT)
Uniform Physician Identifier assigned to Operating
or Other Physician
(UU)
Uniform Physician Identifier assigned to Other
Physician #1
(VV)
Uniform Physician Identifier assigned to Other
Physician #2
(WW)
Accommodations Private Room Charges
(XX)
Accommodations Private Room Days
(YY)
Accommodations Semi-Private Charges
(ZZ)
Accommodations Semi-Private Days
(AAA)
Accommodations Ward Charges
(BBB)
Accommodations Ward Days
(CCC)
Accommodations Intensive Care Charges
(DDD)
Accommodations Intensive Care Days
(EEE)
Accommodations Coronary Care Charges
(FFF)
Accommodations Coronary Care Days
(GGG)
Ancillary Service- Other Charges
(HHH)
Ancillary Service- Pharmacy Charges
(III)
Ancillary Service- Medical/Surgical Supply
Charges
(JJJ)
Ancillary Service- Durable Medical Equipment
Charges
(KKK)
Ancillary Service- Used Durable Medical Equipment
Charges
(LLL)
Ancillary Service- Physical Therapy Charges
(MMM)
Ancillary Service- Occupational Therapy Charges
(NNN)
Ancillary Service- Speech Pathology Charges
(OOO)
Ancillary Service- Inhalation Therapy Charges
(PPP)
Ancillary Service- Blood Charges
(QQQ)
Ancillary Service- Blood Administration Charges
(RRR)
Ancillary Service- Operating Room Charges
(SSS)
Ancillary Service- Lithotripsy Charges
(TTT)
Ancillary Service- Cardiology Charges
(UUU)
Ancillary Service- Anesthesia Charges
(VVV)
Ancillary Service- Laboratory Charges
(WWW)
Ancillary Service- Radiology Charges
(XXX)
Ancillary Service- MRI Charges
(YYY)
Ancillary Service- Outpatient Services Charges
(ZZZ)
Ancillary Service- Emergency Service Charges
(AAAA)
Ancillary Service- Ambulance Charges
(BBBB)
Ancillary Service- Professional Fees Charges
(CCCC)
Ancillary Service- Organ Acquisition Charges
(DDDD)
Ancillary Service- ESRD Revenue Setting
Charges
(EEEE)
Total Charges - Accommodations, for the
Claim
(FFFF)
Total Ancillary Charges, for the Claim
(GGGG)
Total Non-Covered Accommodation Charges,
for the Claim
(HHHH)
Total Non-Covered Ancillary Charges, for
the Claim
(2)
[
(3)
[
(4)
[
(5)
[
(6)
[
(7)
[
(8)
[
(9)
[
(10)
[
(11)
[
(12)
[
(13)
For each public use data file released
and each report issued by the Council, the executive director shall establish
policies and procedures that prevent uniform physician identifiers from being
published when the total number of patients (in a hospital) associated with
specific diagnosis related group counts are less than five or when the number
of physicians associated with a particular diagnosis related group has less
than five uniform physician identification numbers listed in the attending
physician field from the hospital that quarter.
(d)
Release of public use data
discharge encounters
[
(e)
The executive director will make available a public use
data file on magnetic
or electronic
media for each quarter not
later than [
(1)
The executive director shall release public use data from
hospitals that have certified the data as required by §1301.17 of this
title (relating to Certification of Discharge Reports). A hospital's failure
to execute the certification form after six months shall not prevent the executive
director from releasing the hospital's data if the director believes the data
submitted is reasonably accurate and complete. The executive director shall
not include in the public use data file
discharge encounters
[
(2)
If additional discharge
claims {transaction sets}
from one prior quarter to the quarter that is currently being certified
[
(3)
The other sections of these rules not withstanding,
the executive director shall not create a public use data file from the discharge
encounter data
[
(4)
The other sections of these rules not withstanding,
the executive director shall not create or release a public use data file
from discharge
encounter data
[
(f)
The Council shall not charge Texas State agencies a fee
for data requested solely for the internal use of the agency to comply with
Health and Safety Code, §108.012(b). Prior to filling the request of
a state agency without fee, the executive director shall secure an interagency
agreement imposing restrictions on distribution, republication or reuse of
the data in ways that would diminish user fees to the Council.
(g)
The executive director shall establish procedures for screening
all requests to assure that filling the request will not violate the provisions
of Health and Safety Code, §108.013(c).
(h)
The data elements specified for discharge
claims {transaction
sets}
[
(i)
A public use data file which is specified by the requestor
shall not be considered a "report issued by the Council" as referenced in
Health and Safety Code, §108.011(f).
(j)
Requests for
discharge encounters
[
(k)
With any public use data file
, research file or report
prepared by the Council, the executive director shall attach all comments
submitted by providers which relate to any data included in the file. The
Council shall also make these comments available at the Council's offices
and on the Council's Internet site.
(l)
The Council shall review the data elements
listed in subsection (c)(1) of this section annually. The Council, with the
assistance of the technical advisory committee described in Health and Safety
Code, §108.003(g)(5), shall consider the value of each data element to
be added or deleted, including the technical feasibility of establishing data
accuracy and consistency. Additional data elements not currently collected
shall be added in accordance with §1301.14 (a)(4) of this title (relating
to Instructions for Submitting Discharge Files).
(m)
The Council, with the assistance of the
technical advisory committee described in Health and Safety Code §108.003(g)(5),
shall establish the following policies, procedures and guidelines listed in
subsection (n)(1)-(4) of this section regarding the release of data.
(n)
Non-certified data shall be
released provided the following criteria are met:
(1)
the Texas Health Care Information Council Research
Data Request Form is completed and submitted to the Council's executive director;
(2)
the research request is reviewed by the
Scientific Review Panel and it has determined the research proposed outcome
can be achieved with the available data;
(3)
the Council's Scientific Review Panel grants
authorization to the request or restricts access to specified data elements
determined to be inappropriate for the research proposal in accordance with §1301.19
of this title (relating to Scientific Review Panel); and
(4)
the requestor has signed a written data
release agreement and made payment according to the Council's fee schedule.
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 10, 2000.
TRD-200002535
Jim Loyd
Executive Director
Texas Health Care Information Council
Earliest possible date of adoption: May 21, 2000
For further information, please call: (512) 424-6490
Part 16.
TEXAS HEALTH CARE INFORMATION COUNCIL
(1)
] Batch
{Functional
Group}
[
file
]-- A set of computer
claims or {transaction
sets} in a national standard format
[
records
]as specified
in
§1301.20
[
§1301.19
] of this title (relating
to Discharge [
Reports
]
Files
--Records, Data Fields and
Codes) which contains one or more discharge
claims {transaction sets}
[
files
] and other required header and trailer records. A
batch
{functional group}
contains discharge
claims {transaction
sets}
[
files
] for only one hospital.
(2)
] Charge--The amount billed
by a provider for specific procedures or services provided to a patient before
any adjustment for contractual allowances, government mandated fee schedules
or write-offs for charity care, bad debt or administrative courtesy. The term
does not include co-payments charged to health maintenance organization enrollees
by providers paid by capitation or salary in a health maintenance organization.
(3)
] Council--The Texas Health
Care Information Council.
(4)
] Data format- The sequence
or location of data elements on a paper form or electronic record according
to prescribed specifications.
(5)
] Discharge--The formal
release of
an inpatient
[
a patient
] by a hospital; that
is, the termination of a period of hospitalization by death or by disposition
to a residence or another health care provider.
(6)
] Discharge
Claim
{transaction set}
[
File
] --A set of computer
data elements
[
records
] as specified in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) relating to a specific patient.
Except for some normal newborn infants there will be one or more discharge
claims {transaction sets}
[
files
] for each inpatient.
(7)
] Discharge [
report-A
]
File {Communications Envelope and Interchange Envelope}-A
computer file as defined in
§1301.20
[
§1301.19
]
of this title (relating to Discharge [
Reports
]
Files
--Records,
Data Fields and Codes) periodically submitted
by
[
on
]
or on behalf of a hospital in compliance with the provisions of this chapter.
(8)
] Electronic filing--The
submission of computer records in machine readable form by modem transfer
from one computer to another or by recording the records on a nine track magnetic
tape, computer diskette or other magnetic media acceptable to the executive
director.
(9)
] Error--Data submitted
on a discharge
file, batch, claim, {communications envelopes and interchange
envelopes, functional group, or transaction set}
[
report
]
which are not consistent with the format and data standards contained in this
section or with editing criteria established by the executive director, or
the failure to submit required data.
(10)
] Ethnicity - The status
of patients relative to Hispanic background.
(11)
] Executive director--The
chief administrative officer of the Council, or, in the event the Council
is without an executive director, the person designated by the chairperson
of the Council to perform the functions and exercise the authority of the
executive director.
(12)
Geographic identifier--A set of
codes and accompanying maps prepared by the Council covering Texas and adjacent
states with each code consisting of two or more zip codes, a set of codes
and accompanying maps prepared by the Council covering the rest of the United
States consisting of three digit zip codes, a set of codes and accompanying
maps prepared by the Council covering Canada and Mexico consisting of a separate
code for each state or province and a set of codes for each of the other countries.
]
(13)
Health benefit plan - A plan provided
by a health maintenance organization or an approved nonprofit health corporation
certified under the Medical Practice Act, §5.01(a) that holds a certificate
of authority issued by the Commissioner of Insurance under Article 21.52F
of the Insurance Code.
]
(14)
] Health care facility--A
hospital, an ambulatory surgery center licensed under Chapter 243 of the Health
and Safety Code, a chemical dependency treatment facility licensed under Chapter
464 of the Health and Safety Code, a renal dialysis center, a birthing center,
a rural health clinic, or a federally qualified health center as defined by
42 United States Code, §1396(1)(2)(B).
(15)
] Hospital--A public,
for-profit, or nonprofit institution licensed or owned by this state that
is a general or special hospital, private mental hospital, chronic disease
hospital, or other type of hospital.
(16)
] Inpatient--A patient,
including a newborn infant, who is formally admitted to the inpatient service
of a hospital and who is subsequently discharged, regardless of status or
disposition. Inpatients include patients admitted to medical/surgical, intensive
care, nursery, subacute, skilled nursing, long-term, psychiatric, substance
abuse, physical rehabilitation and all other types of hospital units.
(17)
] Other exempted provider
- A hospital exempt from state franchise, sales, ad valorem, or other state
and local taxes that does not seek or receive reimbursement for providing
health care services to patients from any source, including the patient or
any person legally obligated to support the patient; a third party payer;
or Medicaid, Medicare, or any other federal, state or local program for indigent
health care.
(18)
] Other health professional--A
person licensed to provide health care services other than a physician. An
individual other than a physician who admits patients to hospitals or who
provides diagnostic or therapeutic procedures to inpatients. The term
encompasses
[
will encompass
] persons licensed under various
Texas practice statutes, such as psychologists, chiropractors, dentists
, nurse practitioners, nurse midwives,
and podiatrists who are authorized
to admit or treat patients.
(19)
] Patient control number--A
number assigned to each patient by the hospital which appears on each computer
record in a patient discharge
claim {transaction set}
[
file
]. This number is not consistent for a given patient from one hospital
to the next, or from one admission to the next in the same hospital. The Council
deletes or encrypts this number to protect patient confidentiality prior to
release of data.
(20)
] Physician--An individual
licensed under the laws of this state to practice medicine under the Medical
Practice Act [
(Article 4495b, Vernon's Texas Civil Statutes)
].
(21)
] Provider--A physician
or health care facility.
(22)
] Public use data file--A
data file composed of discharge [
files
]
encounters that have
been edited, and verified for accuracy and consistency. This file shall be
appended
with risk and severity adjustment scores
and
[
which have been
] altered by [
the
] deletion, encryption or
other modification of data fields to protect patient and physician confidentiality
and to satisfy other restrictions on the release of hospital discharge data
imposed by statute.
(23)
] Race--A division of
patients according to traits that are transmissible by descent and sufficient
to characterize them as distinctly human types. Hospitals shall report this
data element according to the following racial types: American Indian, Eskimo,
or Aleut; Asian or Pacific Islander; Black; White; or Other.
(24)
] Required minimum data
set--The
list of
data elements which hospitals are required to
submit in a discharge
claim {transaction set}
[
file
]
for each inpatient
discharged from a service unit within the hospital
when the hospital anticipates no payment or bill will be created,
regardless
of whether [
or not
] the hospital would have prepared a
claim
{transaction set}
[
bill
] for the inpatient. The required
minimum data set is specified in
§1301.20(e)
[
§1301.19(d)
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes).
(25)
] Risk adjustment - A
statistical method to account for a patient's severity of illness at the time
of admission and the likelihood of development of a disease or outcome, prior
to any medical intervention.
(26)
] Rural provider - A
health care facility located in a county with a population of not more than
35,000 as of July 1 of the most recent year according to the most recent United
States Bureau of the Census estimate; or located in a county with a population
of more than 35,000 but with 100 or fewer licensed hospital beds and not located
in an area that is delineated as an urbanized area by the United States Bureau
of the Census[
;
] and is not state owned, or not managed or directly
or indirectly owned by an individual, association, partnership, corporation,
or other legal entity that owns or manages one or more other hospitals. A
health care facility is not a rural provider if an individual or legal entity
that manages or owns one or more other hospitals owns or controls more than
50% of the voting rights with respect to the governance of the facility.
(27)
] Severity adjustment
- A method to stratify patient groups by degrees of illness and mortality.
(28)
] Submission--
The
transfer of a
[
A
] set of computer records
(discharge
file, {Communications Envelope and Interchange Envelope}, batch {functional
group} and claims {transaction sets})
as specified in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) that constitutes
the discharge
file {communications envelopes and interchange envelopes}
[
report
] for one or more hospitals.
(29)
] Submitter--
A hospital
or
[
The
]
the
person
who
or organization
which physically prepares discharge [
reports
]
files {communications
envelopes and interchange envelopes}
for one or more hospitals and submits
them to the Council. A submitter may be a hospital or an agent designated
by a hospital or its owner.
(30)
] Uniform facility identifier--A
unique number assigned by the Council to each health care facility in the
state. For hospitals this will be the hospital's state license number.
When
[
Where
] a hospital operates multiple facilities under
one license number, the Council will assign a suffix for each separate facility.
The relationship between facility identifier and the name, license number,
and assigned suffix of the facility is public information.
(31)
] Uniform other health
professional identifier--A unique number assigned by the Council to an individual
other health professional who is reported as
attending
[
admitting
] or treating a hospital inpatient, and composed of numeric, alpha,
or alphanumeric characters, which remains constant across hospitals. The relationship
of the identifier to the health professional-specific data elements used to
assign it is confidential.
(32)
] Uniform patient identifier
- A unique number assigned by the Council to an individual patient and composed
of numeric, alpha, or alphanumeric characters, which remains constant across
hospitals and inpatient admissions. The relationship of the identifier to
the patient-specific data elements used to assign it is confidential.
(33)
Uniform payer identifier--A unique
number assigned by the Council to every third party payer of UB-92 bills.
Whenever possible the Council will use established numbering systems such
as that maintained by the National Association of Insurance Commissioners.
The relationship between payer identifier and the name of the payer is public
information.
]
(34)
] Uniform physician identifier--A
unique number assigned by the Council to any physician or other health professional
who is reported as
attending
[
admitting
] or treating
a hospital inpatient which remains constant across hospitals. The relationship
of the identifier to the physician-specific data elements used to assign it
is confidential.
Filing
] Discharge
Files
[
Reports
]) shall submit
claims {transaction sets}
or a consolidated claim {transaction set} on
[
discharge files on
] all
discharged
inpatients
attended or treated by physicians
to the Council.
Hospitals may submit claims {transaction sets}
or a consolidated claim {transaction set} on all discharged inpatients treated
by other health professionals to the Council.
Hospitals owned by the
federal government and hospitals exempted as rural providers may submit hospital
discharge
claims {transaction sets}
[
files
].
files
] shall be submitted for each patient
for each discharge covering all services and charges from admission through
discharge.
files
] shall normally be submitted for mothers and newborns. Hospitals
are not required to create a separate discharge file for a normal newborn
infant if the delivery is covered by a third party payer and the third party
payer does not require separate
claims {transaction sets}
[
bills
] for the mother and the infant. For any birth where there is no
third party coverage, separate discharge
claims {transaction sets}
[
files
] are required for the mother and the infant.
files
] corresponding to each interim,
revised, or final
claim {transaction set}
[
bills
] or
submit a single consolidated final
claim {transaction set}
[
bill
] for each discharged patient.
a patient
]
has been served in multiple units of a hospital (e.g., acute care, skilled
nursing care, comprehensive medical rehabilitation, substance abuse) during
a single continuous stay, some third party payers require that separate bills
be prepared for services in acute and sub-acute units while others do not.
Where a patient has third party coverage, the discharge
claims
[
files
] submitted by the hospital shall correspond to the bills
submitted to the payer.
Where a patient has no third party coverage,
and the hospital is not submitting a consolidated claim {transaction set}
as authorized in paragraph (4) of this subsection, the discharge claims {transaction
sets} submitted by the hospital shall correspond to the claims {transaction
sets} submitted to the payer.
Where a patient has no third party coverage
and the hospital does not anticipate payment to be received
, the hospital
shall submit a separate discharge
claim {transaction set}
[
file
] for each unit.
patients
] for which the hospital prepares one or more
claims {transaction
sets}
[
bills
] for inpatient services, the hospital shall
submit a discharge
claim {transaction set}
[
file
] corresponding
to each bill containing the required data elements [
required by
]
specified by §1301.20
[
§1301.19
] of this title
(relating to Discharge [
Reports
]
Files
--Records, Data
Fields and Codes) and all other data elements included on the bill whether
included because of the requirements of third party payers or because of hospital
policy. For all patients for
whom
[
which
] the hospital
does not prepare a
claim {transaction set}
[
bill
] for
inpatient services, the hospital shall submit a discharge
claim {transaction
set}
[
file
] containing the required minimum data set.
that
] are covered by 42 USC 290dd-2 and 42 CFR Part
2.1, a hospital shall submit a discharge
claim {transaction set}
[
bill
] containing the data elements required by
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) and all other
data elements included on the bill, whether included because of the requirements
of third party payers or because of hospital policy. The hospital shall replace
the patient identifying information with the default values specified in
§1301.20(f)
[
§1301.19(f)
] of this title (relating
to Discharge [
Reports
]
Files
--Records, Data Fields and
Codes) or submit the patient identifying information if release of patient
identifying information is authorized in writing by the patient or patient's
guardian.
file
]
discharge
files {communications envelopes and interchange envelopes}
by electronic submission
[
reports by electronic filing
] unless
the hospital receives an exemption letter from the
executive director
[
Council
].
files and discharge reports
]
in the format specified in
§1301.20
[
§1301.19
]
of this title (relating to Discharge [
Reports
]
Files
--Records,
Data Fields and Codes).
reports
] data certifications,
exemption requests and other required information to the Council or its agents
at physical or telephonic addresses specified by the executive director. The
executive director shall notify all hospitals and submitters in writing and
by publication in the
Texas Register
at least
30
calendar
days before any change in the addresses.
reports
] or may designate
an agent to submit the
files {communications envelopes and interchange
envelopes}
[
reports
]. If a hospital designates an agent,
it shall inform the Council of the designation in writing at least 30
calendar
days prior to the agent's submission of any discharge
file {communications envelopes and interchange envelopes}
[
report
]. The hospital shall inform the Council in writing at least 30
calendar
days prior to changing agents or making the submissions itself.
Designation of an agent does not relieve the hospital of responsibility for
compliance with this chapter or other related law.
reports
] submitted, as well as
other patient related documentation deemed necessary to audit hospital data
to verify its accuracy and reliability. Each request from the Council shall
detail the reasons for such request, provide the hospital with at least 14
calendar
days advance notice, and ensure that confidentiality of patient
records is maintained.
Filing ] Discharge Files [ Reports ].
file
] discharge reports
files {communications
envelopes and interchange envelopes}
according to the following schedule
as shown in paragraphs (1)-(4) of this subsection unless a hospital has received
an exemption letter from the Council.
report
] covering inpatient discharges occurring between January 1 and
March 31, inclusive, shall be submitted no later than June 1 of the calendar
year in which the discharge occurred.
report
] covering inpatient discharges occurring between April
1 and June 30, inclusive, shall be submitted no later than September 1, of
the calendar year in which the discharge occurred.
report
] covering inpatient discharges occurring between July 1
and September 30, inclusive, shall be submitted no later than December 1 of
the calendar year in which the discharge occurred.
report
] covering inpatient discharges occurring between October
1 and December 31, inclusive, shall be submitted no later than March 1 of
the year following the year in which the discharge occurred.
On or before May 31, 1998, hospitals shall submit
a discharge report drawn from inpatient
]
Inpatient
[
discharges
]
discharge claims
occurring between January 1,
1998, and
December
[
March
] 31, 1998, inclusive[
. This discharge report
] shall be used for test [
and certification
] purposes [
only
]
and for reporting .
[
The
discharge report may include all discharges for the quarter, but the hospital
is only required to submit discharge files covering discharges for any consecutive
30 days of the quarter.
]
The Council intends to use this data
to produce reports for Council meetings and the governor and legislature regarding
the status of the health care data collection system. Data released in these
reports will have no uniform patient identifiers, uniform physician identifiers
or facility identifiers. These reports shall not be considered as the "report'
described in the Texas Health and Safety Code, §108.011(f).
ten working
] days in response to a written request signed by the hospital's chief
executive officer
or chief executive officer's designated agent
.
Requests must be in writing, must be received at least five working days prior
to the due date and must be accompanied by adequate justification for the
delay.
file
] a discharge
file
[
report
] on or before the due date without an extension,
is punishable by a civil penalty pursuant to Health and Safety Code, §108.014.
Filing ] Discharge Files [ Reports ].
report
] may be filed on computer diskettes, nine track tapes or other magnetic
media approved by the executive director. All discharges shall be reported
using the same file and record formats specified in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) regardless of medium.
reports
] may be filed on other magnetic media only with the prior written
approval of the executive director. The executive director will not normally
approve any medium which the Council is not currently equipped to read.
filing
] discharge
files {communications envelopes and interchange envelopes}
[
reports
] on magnetic media and shall make this documentation
available to hospitals at no charge and to the public for the cost of reproduction.
The Council shall notify hospitals or their designated agents directly in
writing at least 90
calendar
days in advance of any change in instructions
for filing discharge
files {communications envelopes and interchange
envelopes}
[
reports
] on magnetic media. The Council's instructions
shall follow Department of Information Resources standards for magnetic media
established under 1 TAC Chapter 201.
reports
] may be
submitted
[
filed
] by modem
using electronic data interchange (EDI). All discharges shall be reported
using the same file
{communications envelope and interchange envelope}
,
batch {functional group}
and
claim {transaction set}
record formats
or loops, segments and data elements
specified
in
§1301.20
[
§1301.19
] of this title (relating
to Discharge [
Reports
]
Files
--Records, Data Fields and
Codes) regardless of the medium of transmission, unless the hospital has obtained
an exemption authorized by §1301.15 of this title (relating to Exemptions
from
Submitting
[
Filing
]). [
Record length is 192
characters for all records.
] The Council shall document instructions
for
submitting
[
filing
] discharge
files {communications
envelopes and interchange envelopes}
[
reports
] by EDI and
shall make this documentation available to hospitals at no charge and to the
public for the cost of reproduction. The Council shall notify hospitals and
their designated agents directly in writing at least 90
calendar
days in advance of any change in instructions for filing discharge
files
{communications envelopes and interchange envelopes}
[
reports
]
by EDI. The Council's instructions shall follow Department of Information
Resources standards for EDI.
filing
] of discharge
files
[
reports
] may
submit
[
file
] discharge
claims {transaction
sets}
[
reports
] using paper UB-92 billing forms. Hospitals
using paper forms are required to provide all data elements specified in
§1301.20
[
§1301.19
] of this title (relating to
Discharge [
Reports
]
Files
--Records, Data Fields and
Codes).
Hospitals receiving approval to submit paper claims shall make
requests to continue submitting paper claims each year between June 1 through
June 14.
filing
] paper UB-92 forms and shall make this documentation available to hospitals
at no charge and to the public for the cost of reproduction. The Council shall
notify hospitals or their designated agents at least 90
calendar
days in advance of any change in instructions for filing paper forms.
Filing ] Requirements.
reports
] to the Council unless the Council determines that the hospital is
a rural provider or other exempted provider. The executive director shall
make a determination of which hospitals are entitled to this exemption at
least annually and shall notify qualifying hospitals by publication in the
files
] on all discharges
that occur
90 calendar
[
30
] days after loss of the exemption.
The initial discharge
file {communications envelope and interchange envelope}
[
report
] shall not be due until
the deadline as specified
in §1301.13(a) of this title (relating to Schedule for Submitting Discharge
Files), for discharge data collected
90
calendar
days after
notice is given. Subsequent discharge
files {communications envelopes
and interchange envelopes}
[
reports
] are due as specified
in §1301.13(a) of this title (relating to Schedule for
Submitting
[
Filing
] Discharge
Files
[
Reports
]).
Filing
] of Discharge
Files
[
Reports
]. Hospitals
that wish to submit discharge
files {communications envelopes and interchange
envelopes}
[
reports
] to the Council more often than quarterly
may do so by requesting an exemption to the standard submission schedule.
The Council may also issue general exemptions based on the processing arrangements
for data collection. Exemption requests meeting the following criteria as
shown in subparagraphs (A)-(D) of this paragraph will normally be approved.
reports which will usually be daily,
weekly or monthly
].
(3)
] Exemption from Electronic
Submission
[
Filing
] of Discharge
Files
[
Reports
]. The Council will grant exemptions from electronic filing of
discharge
claims {transaction sets}
[
reports
] only when
a hospital can demonstrate that it lacks electronic data processing capacity.
If granted, the exemption is valid for one year and must be renewed annually
[
by the hospital
]. The exemption from electronic filing of discharge
claims {transaction sets}
[
reports
] does not change the data
the hospital is required to
submit
[
file
] on each discharge
as specified in
§1301.20
[
§1301.19
] of this
title (relating to Discharge [
Reports
]
Files
--Records,
Data Fields and Codes), nor the schedule for submission specified in §1301.14
of this title (relating to Instructions for
Submitting
[
Filing
] Discharge
Files
[
Reports
]). Exemptions from
electronic reporting to the Council will not normally be granted unless the
hospital shows that it does not currently electronically
submit
[
file
] UB-92 [
bills
]
claims {transaction sets}
[
with
]
to
any payer, or has not done so in the last
12 months prior to the request for exemption.
(4)
] Exemption from electronic
filing in standard formats. Exemptions from electronic filing of discharge
files {communications envelopes and interchange envelopes}
[
reports
] in the standard formats specified in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) shall be granted to hospitals
that demonstrate that alternative formats are universally accepted by payers
and other entities to whom hospitals are required by law or contract to furnish
hospital discharge data for complementary purposes. The exemption from electronic
filing of discharge
files {communications envelopes and interchange envelopes}
[
reports
] in the standard formats does not change the data
elements the hospital is required to
submit
[
file
] on
each discharge as specified in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes), or the schedule for submission specified
in §1301.14 of this title (relating to Instructions for
Submitting
[
Filing
] Discharge
Files
[
Reports
]).
of the hospital
who shall certify
]
certifying
that all information contained
in the request is true and correct.
only those facts and issues
which have been previously presented to the executive director
]. The
Council will decide exemption appeals by majority vote of members present.
only those facts and issues which have
been previously presented to the executive director
]. The Council will
decide exemption appeals by majority vote of members present.
Reports ] and Correction of Errors.
files
] prior to public release, the executive director
shall establish procedures for the review of all discharge
claims {transaction
sets}
[
reports
] to determine whether the
discharge claims
{transaction sets} are
[
report is
] acceptable, as required
by Health and Safety Code, §108.011.
report
] the executive director shall determine if it satisfies minimum criteria
for processing. If it does not, the executive director shall return the discharge
file
[
report
] in the same submission format and media that
is approved for that provider and state the deficiencies in writing within
ten
calendar
days of receipt. The hospital shall resubmit the
file
[
report
] within ten
calendar
days of notification
by the executive director. A discharge
file
[
report
]
does not meet minimum standards for processing under the following circumstances
as shown in paragraphs (1)-(3) of this subsection.
Filing
]
Submitting
Discharge [
Reports
]
Files
).
§1301.19
] of this title (relating
to Discharge [
Reports
]
Files
--Records, Data Fields and
Codes), unless the hospital has received a letter from the Council authorizing
filing in another format.
reports
] accepted for processing and will process all discharge
files
, batches and claims {communications envelope and interchange envelopes,
functional groups and transaction sets}
against the editing criteria
established by this section and by the executive director. Within 30
calendar
days of receipt of an accepted discharge
file, batches
and claims {communications envelope and interchange envelopes, functional
groups and transaction sets},
[
report
] the executive director
shall notify the hospital in detail of all errors detected in the discharge
files, batches and claims {communications envelope and interchange envelopes,
functional groups and transaction sets}
[
report
].
in a discharge report
], the
hospital shall correct all discharge files
, batches and claims {communications
envelope and interchange envelopes, functional groups and transaction sets}
containing errors, add any discharge files
, batches and claims
{communications envelope and interchange envelopes, functional groups and
transaction sets}
determined to be missing from the initial discharge
file, {communications envelope and interchange envelopes}
[
report
] and
submit
[
resubmit
] the
corrected and
previously missing
discharge files
, batches and claims {communications
envelope and interchange envelopes, functional groups and transaction sets}
. If the hospital disagrees with any identified error
or has no
way to correct the identified error (e.g. the street address and ZIP code
recorded were not valid or identifiable and the patient died before the information
could be obtained)
, the hospital shall submit written justification
of the correctness or completeness of its data
or indicate that the claim
{transaction set} data cannot be corrected. (The claim {transaction set} is
as good as it can be)
. Each hospital shall submit such modified and/or
additional discharge
claims {transaction sets}
[
files
]
as may be required to allow the chief executive officer or the chief executive
officer's
designated
agent to certify the discharge report as required
by §1301.17 of this title (relating to Certification of Discharge
Files
[
Reports
]). Corrections to a discharge
claim {transaction
set}
[
report
] shall be submitted in the same medium and format
as the original discharge
claim {transaction set}
[
report
]
unless the executive director approves another medium.
report
] from
a hospital, the executive director shall notify the hospital of any remaining
errors. The hospital shall have ten
calendar
days from
the
date
[
receipt
] of this notice
(notification starts for
each hospital when the "notice of errors" is sent to the hospital)
to
correct the errors noted or submit a written explanation of why the data should
be deemed correct and complete. This process shall be repeated until the executive
director is satisfied that the data submitted by the hospital is substantially
accurate[
and until the hospital is able to certify the discharge report
as required by §1301.17 of this title (relating to Certification of Discharge
Reports)
].
Discharge data that has been edited, returned to hospital
and is not certified may be released and published in the public use data
file as specified §1301.18(e) of this title (relating to Hospital Discharge
Data Release).
reports
]
claims {transaction sets}. The editing criteria
shall be reviewed on an annual basis by the Council with the assistance of
the advisory committee described in Health and Safety Code, §108.003(g)(5).
If acceptance and editing criteria are incorporated into computer software,
and if the software is the property of the Council, the executive director
will make copies of the portions of the software containing the criteria available
on paper or magnetic media. The executive director shall make this information
available to submitters without charge and to others for the cost of reproduction.
report
] which has been [
filed
]
submitted
but contains errors or omissions within the due dates in §1301.13
of this title (relating to Schedule for [
Filing
]
Submitting
Discharge [
Reports
]
Files
) is punishable by a
civil penalty pursuant to Health and Safety Code, §108.014.
Reports ].
120 days
] after
the
last day
[
end
] of each reporting quarter the executive
director shall compile
one or more
[
an
] electronic data
files
[
file
] for each reporting hospital using all discharge
claims {transaction sets}
[
files
] received from
the
[
each
] hospital. The file shall have one
discharge encounter
[
record
] for each patient discharged during the reporting
quarter and one
discharge encounter
[
record
] for any
patient discharged during
one
[
a
] previous reporting
quarter for whom additional discharge
claims {transaction sets}
[
files
] have been received
and one discharge encounter for
corrected claim data on any patients discharged and received from hospitals
authorized in accordance with subsection (b) of this section
.
These
files
[
This file
] will include [
all
] data submitted
by the hospital which the executive director intends to use in the creation
of the public use data file
and supplemental file excluding the uniform
patient identifiers, uniform physician identifiers and data that are calculated
or processed and cannot be released due to contractual obligations
.
The
electronic
data [
file will
]
files, including
reports and any additional information returned to the hospital, allows the
hospital to
provide physicians and other health professionals the opportunity
to review, request correction of, and comment on
the data
[
records
] of
discharged
patients for whom they are shown as
attending
[
admitting
] or treating. The executive director
shall determine the format and medium in which the quarterly
discharge
file (communication's envelope and interchange envelopes) or reports or any
additional information is
[
file will be
] delivered to hospitals.
certify that
] the discharge
encounter
data
[
report
] for each quarter [
is accurate
] using
forms supplied by the Council. The certification form may be signed by a person
designated by the chief executive officer and acting as the officer's agent.
Designation of an agent does not relieve the chief executive officer of personal
responsibility for the certification. If the chief executive officer
or chief executive officer's designated agent
does not believe the quarterly
certification
file
or files
is
or are
accurate,
the officer shall provide the executive director with detailed comments and
[
data
]
provide a written request (on a form supplied by the
Council) to correct data. The executive director shall establish policies
and procedures to determine the necessity and feasibility of the change request
and respond in writing within 7 calendar days of the receipt of the request.
Pending approval, the executive director shall have policies and procedures
established to receive data or information
necessary to correct any
inaccuracy and certify the file subject to those corrections being made.
Corrected data shall be submitted on or prior to six months and 21 calendar
days (Quarter 1 - October 21; Quarter 2 - January 21; Quarter 3 - April 21;
Quarter 4 - July 21) after the last day of each reporting quarter and shall
be included in the public use data file and research data files as specified
in §1301.18 of this title (relating to Hospital Discharge Data Release).
Additional discharge claims {transaction sets} submitted after six months
and 21 calendar days from the end of the reporting quarter shall be placed
in a supplemental file and published with the next quarter's public use data
file. Corrected claims {transaction sets} received after six months and 21
calendar days after the last day of the reporting quarter from hospitals which
have received approval from the executive director to submit corrected claims,
as specified in this subsection shall certify the corrected data in conjunction
with the following quarter's certification file. Corrected claims {transaction
sets} received after six months and 21 calendar days after the last day of
the reporting quarter from hospitals which have not received approval from
the executive director to submit corrected claims, as specified in this subsection,
shall not be published in the next published public use data file. Additional
claims {transaction sets} (not previously submitted) from one quarter prior
to the current quarter that is being certified and that is received on or
before the deadline for submitting corrected data for inclusion in the next
public use data file, as specified in this subsection shall be published in
a supplemental file that is released in conjunction with the public use data
file.
a complete review of hospital records was
accomplished to
]
report
] and any corrections
submitted
;
[
, that
]
, and that
]
is accurate
and complete. The certification shall also represent that
]
and
on its medical staff
]a reasonable
opportunity to review
and comment on
the discharge
data of
patients
[
files
] for which they were the [
admitting
]
attending (as recorded in Record 80 Field 5 (Attending Physician Identifier)
and Field 9 (Attending Physician Name), {(Identification Code Qualifier) Level
- Detail, Position - 250, Loop - 2310A , Segment ID - NM108, Data Element
-66 and (Identification code (number)) Level - Detail, Position - 250, Loop
- 2310A , Segment ID - NM109, Data Element -67 and (Last name) Level - Detail,
Position - 250, Loop - 2310A , (Last name) Segment ID - NM103, Data Element
-1035 and (First name) Level - Detail, Position - 250, Loop - 2310A , Segment
ID - NM104, Data Element -1036 and (Middle name) Level - Detail, Position
- 250, Loop - 2310A , Segment ID - NM105, Data Element -1037} )
or treating
(as recorded in Record 80 Field 6 (Operating or Other Physician Identifier)
and Field 10 (Operating or Other Physician Name), {(Identification Code Qualifier)
Level - Detail, Position - 250, Loop - 2310B , Segment ID - NM108, Data Element
-66 and (Identification code (number)) Level - Detail, Position - 250, Loop
- 2310B , Segment ID - NM109, Data Element -67 and (Last name) Level - Detail,
Position - 250, Loop - 2310B , (Last name) Segment ID - NM103, Data Element
-1035 and (First name) Level - Detail, Position - 250, Loop - 2310B , Segment
ID - NM104, Data Element -1036 and (Middle name) Level - Detail, Position
- 250, Loop - 2310B , Segment ID - NM105, Data Element -1037} or as recorded
in Record 80 Field 7 or 8 (Other Physician Identifier) and Field 11 or 12
(Other Physician Name), {(Other Physician Identification Code Qualifier) Level
- Detail, Position - 250, Loop - 2310C , Segment ID - NM108, Data Element
-66 and {Other Physician Identification code (number)) Level - Detail, Position
- 250, Loop - 2310C , Segment ID - NM109, Data Element -67 and (Last name)
Level - Detail, Position - 250, Loop - 2310C , (Last name) Segment ID - NM103,
Data Element -1035 and (First name) Level - Detail, Position - 250, Loop -
2310B , Segment ID - NM104, Data Element -1036 and (Middle name) Level - Detail,
Position - 250, Loop - 2310C , Segment ID - NM105, Data Element -1037} )
physician or other health professional [
prior to certification,
]
. The physicians or other health professionals may write comments and
have[
corrected any
] errors brought to the [
hospital's
]
attention
of the chief executive officer or the chief executive officer's
designated agent
and [
have included with the discharge report
]
the chief executive officer or the chief executive officer's designated agent
shall include
any comments on the accuracy of the data
and correct
any errors noted
[
submitted
] by
the
physicians
or other health professionals.
If the chief executive officer or the
officer's designee elects not to certify the discharge encounter data for
a specific quarter, a
[
Written
]
written
explanation
of any unresolved [
disagreements with the executive director
]
data issues
concerning the accuracy and completeness of the data at
the time of the certification shall be
included or
attached to
the certification form.
(d)
] Each hospital must
submit
[
file
] its certification
form
[
of
]
for
each quarter's data
to
[
with
] the Council [
within six months
]
by the first day of the six month (Quarter 1
- October 1; Quarter 2 - January 1; Quarter 3 - April 1; Quarter 4 - July
1)
following the last day of the reporting quarter
(Quarter 1 -
March 31; Quarter 2 - June 30; Quarter 3 - September 30; Quarter 4 - December
31)
. Extensions to this period will not be granted.
The Council,
by majority vote, may grant exemptions to hospitals from the requirements
to certify data. Data from hospitals that are exempted from the certification
requirements shall not be released in a public use data file or supplemental
file. Discharge data that has been edited, returned to hospital and is not
certified may be released and published in the public use data file.
(e)
] Hospitals, physicians or other
health professionals may submit concise written comments regarding any data
submitted by them or relating to services they have delivered which may be
released as public use data. Comments shall be submitted to the Council no
later than six months following the last day of the reporting quarter. Commenters
are responsible for assuring that the comments contain no patient or physician
identifying information. Comments shall be submitted electronically using
the methods described in §1301.14(a) and (b) of this title (relating
to Instructions for
Submitting
[
Filing
] Discharge
Files
[
Reports
]).
(f)
] Failure to
return a
[
timely file a
] certification [
of
]
form by the dates
specified in subsection (e) of this section corresponding to
discharge
data previously submitted is punishable by a civil penalty pursuant to Health
and Safety Code, §108.014.
, and are available for public inspection during normal
business hours
]. Copies of such records may be obtained upon request
and upon payment of user fees established by the Council.
The public
use data file shall be available for public inspection during normal business
hours. Discharge claims {transaction sets}
[
Discharge files
]
in the original format as submitted to the Council
are not available
to the public, are not stored at the Council's office and
are exempt
from disclosure pursuant to Health and Safety Code, §108.010 and §108.013,
and shall not be released. Likewise, patient
and physician identifying
[
specific
] data collected by the Council through
editing
[
audits
] of hospital data shall not be released.
(4)
] of this subsection, required for creation
of the public use data file and for other purposes.
(2)
The executive director shall create
a process for assigning geographic identifiers to each discharge record. Each
geographic identifier shall be composed of two or more postal five digit zip
codes. The identity of the zip codes included in each geographic identifier
is public information. The zip codes for each geographic region shall be included
with each public release of this information.
]
(3)
The executive director shall create
a process for assigning uniform payer identifiers to each discharge record.
The identity of the payer associated with each payer identifier is public
information. The executive director shall also create codes designating primary
source of payment. The payer codes shall be included with each public release
of this information.
]
(4)
] The executive director
shall create a process for assigning a uniform facility identifier to each
health care facility and other provider submitting data. The identity of the
health care facility or other provider associated with each facility identifier
is public information. These facility identifiers shall be included with each
public release of this information.
record
]
encounter
for each
inpatient discharge and adding, modifying or deleting data elements [
in the following manner as listed in paragraphs (1)-(11) of this subsection
]
as follows
:
(1)
] delete patient,
and insured name, Social Security Number, address and certificate data elements,
if submitted; delete patient control and medical record numbers. [
Assign
uniform identifiers and county codes;
]
(2)
] convert patient birth
date to age
in years and age in days
;
(3)
] convert admission and
discharge dates to a length of stay measured in days and a code for the day
of the week of the admission;
(4)
] convert procedure and
occurrence dates to day of stay values;
(5)
] delete physician and other
health professional names and numbers: assign uniform identifiers;
(6)
]
attach comments as
mandated by Health and Safety code §108.011(g);
[
convert payer
names and identification numbers to uniform payer identifiers: assign codes
indicating the primary source of payment;
]
(7)
] convert facility name,
address and identification numbers to a facility identifier;
(8)
] convert all procedure
codes to ICD[
-9-CM
]
codes (version that is current for the
date the data was due to be submitted)
;
(9)
] add risk and severity
adjustment scores utilizing an algorithm approved by the Council;
(10)
] add indicators of whether
the hospital is a children's specialty hospital and whether the hospital is
a teaching hospital;
(11)
] add indicators of whether
the patient was served in an acute care unit or in a specialty unit such as
skilled nursing, long-term care, or psychiatric.
files
]. The Council shall release in an aggregate form without uniform
patient, physician or other health professional identifiers public use data
relating to hospitals described by the Health and Safety Code, §108.0025(1)
that are not rural providers
or
because they do not meet the requirements
of §108.0025(2).
seven months
]
the last day of the eighth month
(Quarter 1 - November 30; Quarter 2 - February 28 or 29; Quarter 3 - May 31;
Quarter 4 - August 31)
after the
last day
[
end
]
of the
reporting
quarter.
records
] derived from hospital discharge
claims {transaction sets}
[
files
] which contain
known
[
material
]
errors
either detected by Council established edits or errors reported
by the hospital during the certification process.
The executive director
will include with the public use data file information on the number of discharge
claims {transaction sets}
[
files
] received from each hospital
and the number of discharge
claims {transaction sets}
[
files
] from each hospital included on the public use data file.
files
] become available after the initial release of the public
use data file [
for any quarter
], the executive director will add
these records to the
supplemental file that is released in conjunction
with the
public use data file and make the additional records available
to the public.
reports
] covering discharges occurring in
[
the first quarter of
] 1998. It is the intent of the Council to
utilize this data [
only
] for testing and calibration of its data
processing systems,
to prepare reports for the Council members, the governor
and the legislature,
and to allow hospitals the opportunity to test
and calibrate their own data reporting systems.
reports
] covering discharges
for the
first
[
second
] quarter of
1999
[
1998
] until a public use data file covering discharges for the
second
[
third
] quarter of
1999
[
1998
]
is created and released. The Council will initially release six months of
data in order to provide a more reliable body of data for analysis and decision-making
and to make available public use data files on a quarterly schedule thereafter.
reports
] in
§1301.20
[
§1301.19
] of this title (relating to Discharge [
Reports
]
Files
--Records, Data Fields and Codes) do not constitute "Provider Quality
Data" as discussed in Health and Safety Code, §108.010.
data
files
] including data on one or more providers are matters of public
record and copies of all requests shall be maintained by the Council for two
years from the date of receipt. The executive director
shall make available
on the Council's Internet site and publish in the Council's numbered letter
for hospitals
[
will transmit monthly
] a summary of all requests
for public use data
received [
to all hospitals submitting discharge
data to comply with Health and Safety Code, §108.011(e)
].
When the Council receives data requests for specific hospitals, the executive
director shall notify the affected hospitals of the requests after releasing
the public use discharge data to the requesters.