25 TAC §§73.22, 73.24, 73.25
The Texas Department of Health (department) adopts amendments
to §§73.22, 73.24, and new §73.25 concerning fees for laboratory
services, the certification of drinking water, milk, and shellfish laboratories,
and voluntary environmental laboratory accreditation, with changes to the
proposed text as published in the December 1, 2000, issue of the
Texas Register
(25 TexReg 11863) as a result of comments received during
the 30 day comment period.
An amendment to §73.22 increases fees for laboratories and is needed
to recover the costs to administer the laboratory certification program. An
amendment to §73.24 removes drinking water certification from this section.
Drinking water certification is addressed in new §73.25. New §73.25
implements added Chapter 421 (Senate Bill 1238, Chapter 447, 76th Legislature
1999, Subtitle E, Title 5, Health and Safety Code, "Accreditation of Environmental
Laboratories"). This legislation requires the department to administer the
program and the Board of Health (board) to adopt rules and set fees to defray
the cost of administering the program. Adoption of the rules will allow the
department to meet the requirements to become a National Environmental Laboratory
Accreditation Program approved accrediting authority.
Changes made to the proposed text result from comments received during
the comment period. The details of the changes are described in the summary
of comments that follow. Other minor editorial changes were made for clarification
purposes.
The following comments were received concerning the proposed rules. Following
each comment is the department's response and any resulting change(s).
Comment: Concerning §73.22, one commenter expressed concerns that
"the proposed fees appear to apply equally to accreditation and certification".
Response: The department agrees that the same fee structure is used for
both accreditation and certification. No changes were made as a result of
this comment.
Comment: Concerning the proposed title of §73.25, one commenter suggested
changing the title of the proposed rule to more accurately reflect the two-tiered
program for laboratory certification and accreditation that is described in
the rule.
Response: The department agrees with the commenter and has changed the
title of the proposed §73.25 to " Environmental Laboratory Certification
and Accreditation".
Comment: Concerning proposed §73.25 in general, one commenter expressed
concern "that throughout the proposed rule, the language is difficult to understand
because of the dual certification/accreditation programs."
Response: The department agrees with the commenter and has reorganized
the rule by putting the requirements for certification and accreditation into
separate sections.
Comment: Concerning proposed §73.25 in general, one commenter suggested
there is no need to have a dual program "because EPA's Office of Ground Water
and Drinking Water has recognized that a NELAC accreditation will be acceptable
for SDWA certification". They predict that very few, if any, laboratories
would need to be "certified" and recommended that the department remove the
certification aspects from this proposed rule.
Response: The department agrees in part with the commenter, that the EPA
will accept NELAC accreditation for SDWA certification, however, the two-tiered
approach described in this section ensures that the small laboratories, that
are so vital to the Texas Natural Resource Conservation Commission's Drinking
Water Program, will not be forced out of business due to the cost of regulatory
compliance. These small laboratories will be required to meet the minimum
requirements in the Environmental Protection Agency's, Manual for the Certification
of Laboratories Analyzing Drinking Water as described in §73.25(e). No
changes were made as a result of this comment.
Comment: Concerning proposed §73.25, one commenter observed that while
certain NELAC standards are specifically addressed in the proposed rule, others
appear to be addressed (only) through general references to the NELAC documents
and suggests that only general references to the NELAC standards be used in
the rules with detailed information provided in guidance documents or that
the proposed rules add specific NELAC requirements which they identified.
Response: The department agrees with the commenter, however the department
feels that specific references provide the details that a laboratory needs
to comply with this section. No changes were made as a result of this comment.
Comment: Concerning proposed §73.25, one commenter suggested that
the department "make it more clear that accreditation of laboratories may
include laboratories performing tests in compliance with the Resource Conservation
and Recovery Act (RCRA) and other statutes that involve environmental measurement.
Response: The department disagrees because it will only offer accreditation
for testing in compliance with the Safe Drinking Water Act and the Clean Water
Act at this time. No changes were made as a result of this comment.
Comment: Concerning proposed §73.25(b)(1) and (2), one commenter suggested
that the phrase "that is certified" be deleted from the definitions of "Accreditation"
and "Certification".
Response: The department agrees with the commenter and has revised the
definitions.
Comment: Concerning proposed §73.25(b)(5)(A), several commenters expressed
concern that the definition of "environmental laboratory" was too restrictive
and proposed alternate definitions.
Response: The department agrees with the commenters and has expanded the
definition.
Comment: Concerning proposed §73.25(e)(3), one commenter recommended
that this section be removed because it conflicts with NELAC standards.
Response: The department agrees with the commenter and has removed the
paragraph.
Comment: Concerning proposed §73.25(f)(4)(B), one commenter stated
that the language in this section appears to indicate that laboratories accredited
by third party organizations would automatically be granted NELAC accreditation
which is in direct conflict with NELAC standards. The commenter states further
that if the intent of the language is to allow such accreditation to occur,
the language should be removed.
Response: The department disagrees with the commenter, this subsection
refers to the requirement for an on-site assessment, not accreditation. No
changes were made as a result of this comment.
Comment: Concerning proposed §73.25(f), one commenter stated that
"it is unclear which portions of section §73.25(f) apply to all laboratories
and which apply to in-state laboratories only and which apply to accreditation
versus certification".
Response: The department agrees with the commenter and has clarified the
rule by placing the requirements for certification and accreditation into
separate subsections in new §73.25(e) and (f).
Comment: Concerning proposed §73.25(f)(1)(D), one commenter suggested
that the proposed language "location of laboratory" be replaced with "physical
address".
Response: The department agrees with the commenter and has added suggested
change to new §73.25(e)(2)(A)(vi).
Comment: Concerning proposed §73.25(f)(1)(A)-(K), one commenter stated
that the listing of items required on the application does not include information
required by the NELAC standard.
Response: The department agrees with the commenter and has referenced §§4.1.7.1
and 4.1.7.2 of the NELAC standards in the new §73.25(f)(3)(A) which refers
to the completion of an application for accreditation.
Comment: Concerning proposed §73.25(f)(2), one commenter identified
an incorrect reference.
Response: The department agrees and has made the correction to new §73.25(e)(2)(B).
Comment: Concerning proposed §73.25(f)(3), §73.25(h), and §73.25(k)(1),
two commenters recommended that the term "interdependent analyte group" be
removed from the rule because the concept no longer exists in the NELAC standard.
Response: The department agrees with the commenters and has made the suggested
change to new §73.25(e)(4), and §73.25(e)(7).
Comment: Concerning proposed §73.25(f)(3)(C), several commenters stated
that the categories of testing in these sections were incorrect and or restrictive.
Response: The department agrees and has rewritten new subsection (f).
Comment: Concerning proposed §73.25(f)(4), one commenter expressed
concerns that out-of-state laboratories would gain a competitive advantage
compared to in-state laboratories if they were exempt from paying accreditation
fees.
Response: The department disagrees. The proposed fee structure for accreditation
and certification of laboratories includes both an administrative fee and
a category fee. Each applicant must pay the administrative fee and the appropriate
category fee (microbiology, radiochemistry, etc) for the fields of testing
for which they seek accreditation. The purpose of the category fees is to
recover the cost of performing an on-site assessment. Since out-of-state laboratories
are accredited through reciprocity and the department does not perform the
on-site assessment the department has exempted them from paying the category
fees. No changes were made as a result of this comment.
Comment: Concerning proposed §73.25(f)(6), one commenter stated that
the proposed rules refer to "applicant" and "applicant laboratory", which
have not been defined, interchangeably with "laboratory". The commenter suggested
using "laboratory" throughout.
Response: The department agrees with the commenters suggestion to replace
the terms "applicant" and "applicant laboratory" with "laboratory" and has
made the suggested change throughout new §73.25(e) and (f).
Comment: Concerning proposed §73.25(f)(6), one commenter noted that
the department had incorrectly stated that the statement of compliance must
be signed and dated by the laboratory owner, director and quality assurance
officer and that this statement was a contradiction to the NELAC standard.
Response: The department agrees and has deleted the statement. The correct
signature requirements for the statement of compliance are included in the
broad reference to NELAC accreditation requirements found in new §73.25(f)(3).
Comment: Concerning proposed §73.25(g)(1), one commenter stated that
the terms "accreditation" and "certification " appear to be used interchangeably
and that the rules are unclear regarding whether the department intends to
accept out-of-state accreditation by a NELAP-approved accrediting authority,
a state or federal SDWA certification authority, a third-party accrediting
organization, or all of these for purposes of Texas SDWA certification. The
commenter suggests revising the proposed rules to accept NELAP approved accrediting
authorities and state SDWA certification authorities.
Response: The department agrees with the commenter and has made the changes
suggested with regard to acceptance of NELAP approved accrediting authorities
and state SDWA certification authorities. The department has eliminated the
confusion related to "accreditation" and "certification" by placing the requirements
for accreditation and certification in separate sections of the rule in §73.25(e)
and (f).
Comment: Concerning proposed §73.25(g)(3), one commenter stated that
the proposed rules were unclear regarding whether a state's certificate or
certification program must meet the departments requirements and suggested
replacing "certificate" with "certification program".
Response: The department agrees and has made the suggested change to new §73.25(e)(3)(B)
and (C).
Comment: Concerning proposed §73.25(17) renumbered to §73.25(19),
one commenter stated that the terms "stringent criteria" in the definition
of "Proficiency testing study provider" are not adequately defined and suggested
an alternate definition.
Response: The department agrees in part with the commenter that the terms
"stringent criteria" are vague. However this definition was taken directly
from the NELAC standard. No changes were made as a result of this comment.
Comment: Concerning proposed §73.25(g)(3) and (4), one commenter stated
that these sections of the proposed rule imply that the department will review
other state programs for adequacy and that it is difficult to determine whether
this applies to certified and/or accredited laboratories. Furthermore, such
a review would be considered a supplemental requirement under NELAC, allowable
only with approval of NELAC.
Response: The department agrees with the commenter and has reorganized
the rule by putting the requirements for certification and accreditation into
separate subsections and removed the statement referring to review of other
state programs from the subsection on accreditation.
Comment: Concerning proposed §73.25(g)(5), one commenter suggested
using "revoked" instead of "downgraded" which has not been defined.
Response: The department agrees and has substituted the word "revoked"
for "downgraded" in new §73.25(e)(10)(D) and (f)(10)(B).
Comment: Concerning proposed §73.25(h)(1), one commenter noted that
the statement that laboratories must analyze PT samples for each analyte/analyte
group where available should be clarified to indicate, "that PT samples are
only required to be analyzed for those analytes established by NELAC".
Response: The department agrees with the commenter and has clarified the
PT requirements for certification and accreditation in new §73.25(f)(5)(A).
Comment: Concerning proposed §73.25(h)(3), one commenter suggested
that the reference to "prior approval" be deleted.
Response: The department agrees with the commenter and has made the requested
change to new §73.25(e)(4)(C).
Comment: Concerning proposed §73.25(h)(6), one commenter states that
the proposed rules are unclear regarding whether an out-of-state laboratory
may direct a proficiency test provider to submit results to the department
electronically and suggests adding language to allow this.
Response: The department agrees with the commenter and has deleted the
statement about out-of-state laboratories so that all laboratories have the
option of directing a proficiency test provider to submit results to the department
electronically, in new §73.25(e)(4)(E).
Comment: Concerning proposed §73.25(h)(9) and (10), one commenter
suggested that these sections are duplicative and recommends that §73.25(h)(10)
be deleted.
Response: The department agrees with the commenter that these sections
appear to be duplicative, however §73.25(h)(9) states the proficiency
testing requirements for accreditation while §73.25(h)(10) states the
proficiency testing requirements for certification. This issue has been resolved
by placing the requirements for certification and accreditation in separate
subsections of the rule in new §73.25(e) and (f).
Comment: Concerning proposed §73.25(i)(5), one commenter suggests
that this section appears to allow NELAP accreditation by third-party accreditation
organizations which conflicts with the NELAC standard.
Response: The department agrees and has added language that limits the
scope of a third-party's responsibility to perform on-site assessments to
new §73.25(f)(6)(A)(iii).
Comment: Concerning proposed §73.25(j)(3), one commenter noted that
the proposed rules are unclear regarding the scope and form of the department's
response to a corrective action report.
Response: The department agrees with the commenter and has added clarifying
language to new §73.25(e)(6)(C).
Comment: Concerning proposed §73.25(j)(2), one commenter suggested
adding "to the department" at the end of the sentence.
Response: The department agrees and has made the suggested change to new §73.25(e)(6)(B).
Comment: Concerning proposed §73.25(j)(6) and (8), one commenter stated
that these proposed rules appear to conflict with each other and are unclear
regarding the process for releasing information and suggested making §73.25(j)(8)
an exception to §73.25(j)(6) and deleting the phrase "and are to be released".
Response: The department agrees and has made the suggested change to new §73.25(e)(6)(F)
and proposed §73.25(j)(8) was deleted.
Comment: Concerning proposed §73.25(k)(3), one commenter states that
this section implies that the department would approve the methods laboratories
would use which is not a NELAC requirement and suggests that it be removed.
Response: The department agrees and the statement has been removed.
Comment: Concerning proposed §73.25(o), two commenters noted that
this section of the proposed rule appears to address regulatory compliance
rather than laboratory accreditation and recommends that it be removed.
Response: The department agrees and has made the recommended change.
Comment: Concerning proposed §73.25(p)(5), one commenter is concerned
that the proposed rules are unclear regarding who must apply on behalf of
a laboratory for a hearing.
Response: The department agrees and has added appropriate language to new §73.25(e)(10)(D).
Comment: Concerning proposed §73.25(q), one commenter states that
the notification requirements in this section omit some of the key criteria
for notification identified in the NELAC standard and suggests that they should
be added.
Response: The department agrees and has made the suggested change to new §73.25(e)(11).
The commenters where the American Council of Independent Laboratories,
TXU Electric and Gas, The Texas Eastman Division of the Eastman Chemical company
and the Texas Natural Resource Conservation Commission. All commenters were
in favor of the rules, however, they raised questions, offered comments for
clarification purposes, and suggested clarifying language concerning specific
provisions in the rules.
The amendments and new section are adopted under Health and Safety
Code, §421.003, which provides the board the authority to set an accreditation
fee in an amount sufficient to defray the cost of administering Chapter 421;
and §421.005, which provides the board the authority to adopt rules to
implement Chapter 421 and minimum performance and quality assurance standards
for accreditation of an environmental testing laboratory, §12.031 - 12.032
which allows the board to establish fees for public health services, and §12.001
which provides the board with the authority to adopt rules for the performance
of every duty imposed by law on the board, the department, and the commissioner
of health.
§73.22.Fees
(a)
Purpose. This section establishes fees pursuant to the
Health and Safety Code, §§12.031, 12.032, and 12.034 for laboratory
services provided by the Bureau of Laboratories (bureau) of the Texas Department
of Health (department). The fees will enable the department to offset costs
incurred when delivering certain laboratory services.
(b)
General. Services are offered at the discretion of the
department subject to laws and rules in effect at the time of the request
for services.
(1)
The fees assessed are intended to recover the reasonable
service costs and shall not exceed the costs of providing the service as determined
by the department.
(2)
Each fee for which a maximum cap is set within this section
shall be calculated annually by department staff in accordance with paragraph
(1) of this subsection.
(3)
A schedule of all fees will be available upon request from
the Texas Department of Health, Bureau of Laboratories, 1100 West 49th Street,
Austin, Texas 78756, (512) 458-7318.
(4)
The department will determine whether a fee must be paid
with submission of the specimen or whether the department will bill later
for the fee unless stated otherwise in this section.
(5)
The submission of specimens to the department shall be
in compliance with the bureau's Manual of Reference Services and other written
instructions established by the bureau.
(A)
The manual outlines clinical and scientific standards,
procedures and requirements of the department.
(B)
Failure to submit a specimen as required may result in
the department's refusal to perform the requested services.
(C)
The manual and other written instructions may be obtained
upon request from the Texas Department of Health, Bureau of Laboratories,
1100 West 49th Street, Austin, Texas 78756, (512) 458-7318.
(6)
Failure to pay a fee in a timely manner may result in the
department's refusal to accept specimens or samples until the fee is paid.
(7)
A fee paid is nonrefundable.
(c)
Fees.
(1)
The annual fees for certification of milk, shellfish, and
environmental laboratories and proficiency testing for milk laboratories are
as follows:
(A)
antibiotic milk laboratories--$250;
(B)
milk industry laboratories--$400;
(C)
full service milk laboratories--$500;
(D)
milk proficiency testing (non-Texas certified laboratories)--$250;
(E)
shellfish laboratory--$500;
(F)
environmental laboratory administrative fee -- $460;
(G)
environmental laboratory microbiology category fee -- $115;
(H)
environmental laboratory radiochemistry category fee --
$430;
(I)
environmental laboratory chemistry category fee for a single
category -- $430;
(J)
environmental laboratory chemistry category fee for two
categories -- $860;
(K)
environmental laboratory chemistry category fee for three
categories -- $1290 and/or;
(L)
environmental laboratory chemistry category fee for four
or more categories -- $1720;
(2)
The fee for testing blood for the presence of lead shall
not exceed $10 per test.
(3)
The fee for a newborn screening test kit shall not exceed
$20 per test kit.
(4)
The fees for testing of bottled water, drinking water systems,
drinking water fountains in day care centers or schools, or individual home
drinking water systems shall not exceed the following amounts:
(A)
tests for minerals and physical properties:
(i)
chloride--$22.50;
(ii)
fluoride--$22.50;
(iii)
nitrate--$30;
(iv)
nitrite--$30;
(v)
sulfate--$22.50;
(vi)
total dissolved solids--$37.50;
(vii)
phenols--$66;
(viii)
turbidity--$24;
(ix)
color--$30;
(x)
odor--$37.50;
(xi)
bromate--$83;
(xii)
bromide--$35;
(xiii)
total organic carbon, water--$53;
(xiv)
chlorate--$75;
(xv)
chlorite--$75;
(xvi)
nitrate and nitrite--$27;
(xvii)
routine water (minerals panel)--$180; and
(xviii)
UV 254--$75;
(B)
tests for trace metals:
(i)
all metals panel: Al, Sb, As, Ba, Be, Cd, Cr, Cu, Fe, Pb,
Mn, Hg, Ni, Se, Ag, Th, Zn--$357;
(ii)
total recoverable metals digestion (performed only if
turbidity equals or exceeds 1 NTU)--$36;
(iii)
Pb-Cu--$27;
(iv)
Pb--$22;
(v)
cadmium--$22;
(vi)
arsenic--$22;
(vii)
antimony--$22;
(viii)
ICP metals panel: Ba, Cr, Cu, Fe, Mn, Ag, Zn, Al, Ni,
Be--$165;
(ix)
mercury--$31;
(x)
selenium--$22;
(xi)
single ICP metal--$22; and
(xii)
thallium--$22;
(C)
tests for organics:
(i)
volatile organic compounds, including trihalomethanes--$180;
(ii)
ethylene dibromide (EDB) and dibromochloropropane (DBCP)--$192;
(iii)
carbamate insecticides--$246;
(iv)
chlorophenoxy herbicides--$270;
(v)
polychlorinated biphenyl and chlorinated insecticides--$280;
(vi)
polyaromatic hydrocarbons (PHA), phthalates--$354;
(vii)
diquat--$297;
(viii)
endothall--$439;
(ix)
glyphosate--$208;
(x)
haloacetic acids (EPA method 552)--$370;
(xi)
haloacetonitriles (EPA method 551)--$231;
(xii)
insecticides, drinking water (EPA method 505)--$225;
(xiii)
organophosphate insecticides, drinking water (EPA method
507)--$340;
(xiv)
polychlorinated biphenyls (PCB), drinking water (EPA
method 508A)--$360; and
(xv)
trihalomethanes, drinking water (EPA method 502.2)--$82;
(D)
radiochemical testing:
(i)
gross alpha and beta--$111;
(ii)
total alpha emitting radium--$87;
(iii)
radium 226--$100;
(iv)
radium 228--$84;
(v)
uranium isotopes--$93; and
(vi)
radon--$81;
(E)
bacteriological examination for coliforms--$20; and
(F)
miscellaneous drinking water chemistry procedures--$96
per hour.
(5)
The fees for testing environmental samples from nuclear
power plants and other users or holders of radiation sources shall not exceed
the following amounts:
(A)
miscellaneous (per hour) Nuclear Chemical Branch--$96;
(B)
gross alpha or beta, water--$99;
(C)
gross alpha and beta, water--$111;
(D)
gamma emitting isotopes, water--$91;
(E)
radium-226, water--$100;
(F)
alpha spectrum preparation, water--$162;
(G)
radium-228, water--$84;
(H)
uranium isotopes, water--$93;
(I)
thorium isotopes, water--$87;
(J)
plutonium, water--$88;
(K)
tritium, water--$61;
(L)
total alpha emitting radium, water--$87;
(M)
radon, water--$81;
(N)
strontium-89 or 90, water--$124;
(O)
carbon-14, water--$133;
(P)
gross alpha or beta, soil--$79;
(Q)
gross alpha and beta, soil--$100;
(R)
gamma emitting isotopes, soil--$138;
(S)
alpha spectrum preparation, soil--$151;
(T)
radium-226, soil--$133;
(U)
radium-228, soil--$108;
(V)
uranium isotopes, soil--$84;
(W)
thorium isotopes, soil--$87;
(X)
plutonium, soil--$88;
(Y)
tritium, soil--$98;
(Z)
strontium-89 or 90, soil--$160;
(AA)
gross alpha or beta, vegetation/tissue--$79;
(BB)
gross alpha and beta, vegetation/tissue--$109;
(CC)
gamma emitting isotopes, vegetation/tissue--$135;
(DD)
alpha Spectrum preparation, vegetation/tissue--$151;
(EE)
radium-226, vegetation/tissue--$133;
(FF)
radium-228, vegetation/tissue--$96;
(GG)
uranium isotopes, vegetation/tissue--$84;
(HH)
thorium isotopes, vegetation/tissue--$87;
(II)
plutonium, vegetation/tissue--$88;
(JJ)
tritium, vegetation/tissue--$97;
(KK)
strontium-89 or 90, vegetation/tissue--$160;
(LL)
gross alpha or beta, wipe/filter/cartridge--$48;
(MM)
gross alpha and beta, wipe/filter/cartridge--$63;
(NN)
alpha spectrum preparation, wipe/filter/cartridge--$151;
(OO)
radium-226, wipe/filter/cartridge--$133;
(PP)
radium-228, wipe/filter/cartridge--$96;
(QQ)
uranium isotopes, wipe/filter/cartridge--$84;
(RR)
thorium isotopes, wipe/filter/cartridge--$87;
(SS)
plutonium, wipe/filter/cartridge--$88;
(TT)
tritium, wipe/filter/cartridge--$61;
(UU)
strontium-89 or 90, wipe/filter/cartridge--$160;
(VV)
carbon-14, wipe/filter/cartridge--$142;
(WW)
gamma emitting isotopes, wipe/filter/cartridge--$78;
(XX)
asbestos identification--$55;
(YY)
asbestos fiber counting--$46;
(ZZ)
dust identification--$60;
(AAA)
organic chemicals, by group, such as insecticides, herbicides,
volatile organic compounds, semi-volatile organic compounds in water or soil/sediment,
including routine sample preparation procedures--$542 per group per sample;
(BBB)
metals, per analyte in water or soil/sediment, including
routine sample preparation procedures--$77 per analyte per sample; and
(CCC)
inorganic chemicals, per analyte in water or soil/sediment--$105
per analyte per sample.
(d)
Newborn screening procedures.
(1)
Newborn screening is required by the Health and Safety
Code, Chapter 33.
(2)
The department through the bureau will provide newborn
screening test kits upon written request from a provider of newborn screening.
A test kit is the department-designed collection device, demographic information
form and envelope used to submit a newborn's blood specimens for screening
by the bureau. A separate test kit is required for each screening panel. Each
newborn must have two screening panels performed. Additional screening panels
may be necessary under certain circumstances. Testing providers include hospitals,
birthing centers, physicians, midwives, and clinics.
(3)
The department shall accept only its test kit for submission
of specimens.
(4)
The department will provide test kits for Medicaid-eligible
or charity care newborns at no cost to the provider.
(5)
The department will provide test kits for all other newborns
at a fee as described in subsection (c)(3) of this section.
(6)
A Medicaid-eligible newborn is a patient whose mother is
a Medicaid recipient or who is otherwise eligible for Medicaid coverage for
the newborn-related services. A charity care newborn is a patient who is not
insured and is not covered or eligible to be covered for newborn screening
services by Medicaid or any other government program.
(7)
When a provider requests test kits, the provider must identify
the number estimated to be needed for Medicaid-eligible newborns, charity
care newborns, and other newborns. The provider's estimates shall be based
on the provider's newborn screening services provided in the most recent fiscal
or calendar year if the provider has previously provided these services. A
provider shall provide further information upon request of the department
to verify the appropriateness of the number of test kits provided at no cost.
(8)
The department will bill the requesting provider for test
kits when the test kits are sent to the provider. Payment is due within 120
days from the provider's receipt of the test kits.
(9)
A provider may use the no-cost test kit only for a Medicaid-eligible
or charity care newborn.
(10)
A provider shall ensure that the identifying and demographic
information provided with the test kit is complete and accurate when submitted
to the department.
(11)
A provider may use the department's previous newborn screening
forms until May 31, 1998. Beginning on June 1, 1998, all providers must use
the department's new test kits for newborn specimens.
§73.24.Certification of Milk and Shellfish Laboratories
(a)
Purpose. This section establishes the procedures for milk
and shellfish laboratories to become certified laboratories under federal
or state law.
(b)
Definitions. The following words and terms, when used in
this section, shall have the following meanings unless the text clearly indicates
otherwise.
(1)
Assessment--A fact-finding process performed either by
an approved third party or by the Texas Department of Health (department)
in which information and observations are collected and evaluated for the
purpose of judging the laboratory's conformance with established certification
standards. Assessment includes an onsite inspection.
(2)
Certification--An official and legal approval granted by
the department to a laboratory, permitting analysis of milk or shellfish samples
in accordance with applicable federal and state laws and rules based on the
process outlined in this section. Certification means that a certified laboratory
has been judged capable of performing the analyses for which it is certified
correctly. Certification does not imply or mean that the department certifies
the results produced by the certified laboratory.
(c)
Certification application.
(1)
A laboratory must submit an application for certification
directly to the department on a form specified by the department.
(2)
Payment of the appropriate fee for certification under §73.22
of this title (relating to Fees) must accompany the application.
(3)
Payment may be by check or money order made payable to
the Texas Department of Health.
(4)
A laboratory may apply for certification in a single category
or any combination of categories from among the following: milk analysis-antibiotics,
milk analysis-raw, milk analysis-full service, or shellfish analysis-full
service.
(5)
The department shall perform an assessment for each milk
and shellfish laboratory applying for certification.
(6)
Each certified laboratory must reapply for certification
every two years and pay the appropriate certification fee. After initial certification,
the laboratory will be assessed the certification fee on an annual basis.
(d)
Standards.
(1)
The minimum standards for certification are as specified
by the United States Environmental Protection Agency (EPA) applying to drinking
water and the United States Food and Drug Administration (FDA) applying to
milk and shellfish. These specifications are available for review during normal
business hours at the department's Bureau of Laboratories, 1100 West 49th
Street, Austin, Texas.
(2)
Each applicant laboratory will be evaluated, at a minimum
on the following factors: credentials and experience of staff, quality assurance
plan, manuals of procedures, performance on evaluation unknowns, equipment,
calibrations and standards, methodology, facilities, sample acceptance policies,
sample tracking, record keeping, reporting, and results interpretation.
(e)
Inspections. The department may conduct inspections of
laboratories to ascertain adherence to minimum standards and the effectiveness
of the certification system. For laboratories for which the department serves
as both the assessing and certification authority, inspections will be conducted
on at least a biennial basis.
(f)
Withdrawal of certification.
(1)
A laboratory must meet all minimum standards, pass all
performance evaluation sets, and pass onsite inspection no less than every
two years to be certified.
(2)
A laboratory that fails to meet requirements by scoring
outside the acceptable limits on a set of performance evaluation unknowns,
has serious deficiencies at the time of an onsite inspection, fails to notify
the department within 30 days of major changes which might impair analytical
capability (personnel, equipment, or location), or fails to notify the state
or public of certain problems as required by notification regulations may
be placed on provisionally certified status.
(3)
Failure on two consecutive performance evaluation sets
or failure to correct major deficiencies following onsite inspection may result
in the withdrawal of certification. The correction action must take place
within the time frames set by the appropriate federal regulatory authority,
which are 90 days or less.
(4)
Certification may be suspended or revoked immediately if
the standards of the EPA or FDA require suspension or revocation, or if continued
operation of the laboratory will jeopardize public health. Due process will
be afforded to the laboratory whose certification is revoked or suspended.
(5)
Certification shall be revoked for a laboratory which submits
as its own work the results for analysis of any performance evaluation sample
which was analyzed by a different laboratory. The laboratory may not reapply
for certification for a period of not less than three years.
§73.25.Environmental Laboratory Certification and Accreditation
(a)
Purpose. This section establishes a two-tiered program
for the certification and accreditation of environmental laboratories. The
first tier of this program is established to certify laboratories performing
microbiological and chemical analysis of drinking water for compliance with
EPA regulations issued pursuant to the Safe Drinking Water Act (SDWA). The
second tier of this program is established to accredit laboratories performing
analysis for compliance with the SDWA and the Clean Water Act (CWA) federal
programs that voluntarily comply with the consensus standards adopted at the
National Environmental Laboratory Accreditation Conference (NELAC).
(b)
Definitions. The following words and terms when used in
this section shall have the following meanings unless the context clearly
indicates otherwise.
(1)
Accreditation--The recognition of a laboratory as having
met the requirements of subsection (f) of this section.
(2)
Accrediting Authority--The territorial, state or federal
agency having responsibility and accountability for environmental laboratory
accreditation and which grants accreditation.
(3)
Certification--The recognition of a laboratory as having
met the requirements of subsection (e) of this section.
(4)
CWA--The Clean Water Act also known as the Federal Water
Pollution Control Act.
(5)
Deficiency--A noncompliance with one or more of the requirements
of this section.
(6)
Environmental laboratory--a scientific laboratory that
performs analyses to determine the chemical, molecular, or pathogenic components
of drinking water, wastewater, hazardous wastes, soil, or air.
(7)
EPA--The United States Environmental Protection Agency.
(8)
Federal Water Pollution Control Act (Clean Water Act)--The
enabling legislation under 33 United States Code §§1251 et seq.,
Public Law 92-50086, Stat. 816, that empowers EPA to set discharge limitations,
write discharge permits, monitor, and bring enforcement action for non-compliance.
(9)
Fields of Testing--NELAC's approach to accrediting laboratories
by program, method and analyte or component.
(10)
Interim accreditation--The temporary accreditation status
for a laboratory that has met all accreditation criteria except for a pending
on-site assessment, which has been delayed for reasons beyond the control
of the laboratory.
(11)
Interim certification--The temporary certification status
for a laboratory that has met all certification criteria except for a pending
on-site assessment, which has been delayed for reasons beyond the control
of the laboratory.
(12)
NELAC--The National Environmental Laboratory Accreditation
Conference.
(13)
NELAC Standards--Standards that include procedures for
consistently evaluating and documenting the ability of laboratories performing
environmental measurements to meet nationally defined standards established
by the National Environmental Laboratory Accreditation Conference.
(14)
NELAP--The National Environmental Laboratory Accreditation
Program.
(15)
NELAP Approved Accrediting Authority--An accrediting authority
that has received recognition from NELAP.
(16)
NELAP Primary Accrediting Authority--The agency or department
designated at the Territory, State or Federal level as the recognized authority
with the responsibility and accountability for granting NELAC accreditation
for a specified field of testing.
(17)
NELAP Secondary Accrediting Authority--The territorial,
state of federal agency that grants NELAC accreditation to laboratories, based
upon their accreditation by a NELAP-recognized Primary Accrediting Authority.
(18)
Proficiency testing program--The aggregate of providing
rigorously controlled and standardized environmental samples to a laboratory
for analysis, reporting of results, statistical evaluation of the results
and the collective demographics and results summary of all participating laboratories.
(19)
Proficiency testing study provider--Any person, private
party, or government entity that meets stringent criteria to produce and distribute
NELAC proficiency testing samples, evaluate study results against published
performance criteria and report the results.
(20)
Revoke--To remove a laboratory's certification or accreditation
or the approval for a certified or accredited laboratory to perform one or
more specified methods.
(21)
Safe Drinking Water Act (SDWA)--The enabling legislation,
42 United States Code §§300f
et seq.
(1974), (Public Law 93-523), that requires the EPA to protect the quality
of drinking water in the United States by setting maximum allowable contaminant
levels, monitoring, and enforcing violations.
(22)
SDWA--The Safe Drinking Water Act.
(23)
Suspension--The temporary removal of a laboratory's accreditation
or certification for a defined period of time, which shall not exceed 6 months,
to allow the laboratory time to correct deficiencies or areas of non-compliance
with this rule.
(24)
TNRCC--The Texas Natural Resource Conservation Commission.
(c)
Administration by department. The department shall administer
the environmental laboratory certification and accreditation program established
by the Health and Safety Code, Chapter 421 and this section.
(d)
Implementation.
(1)
Laboratories currently certified by the department have
two years from promulgation of this rule to comply with all requirements of
this rule.
(2)
The department shall not implement subsection (f) of this
section until it is recognized as an accrediting authority by NELAP.
(e)
Certification.
(1)
Standard for certification. A laboratory certified by the
department pursuant to this rule shall comply with the standards outlined
in the EPA's Manual for the Certification of Laboratories Analyzing Drinking
Water, EPA 815-B-97-001, March 1997, and is adopted by reference into this
rule. This document is available for review during normal business hours at
the department's Bureau of Laboratories, 1100 West 49th Street, Austin Texas.
(2)
Certification requirements. To become certified, to renew
certification, or to become recertified under this rule, a laboratory must:
(A)
submit a completed application to the department, on forms
provided by the department that shall include:
(i)
the legal name of the laboratory;
(ii)
the mailing address;
(iii)
the billing address;
(iv)
the name of the laboratory owner;
(v)
the mailing address of the owner;
(vi)
the physical address of the laboratory;
(vii)
the name and phone number of technical director(s), however
named, and the lead technical director (if applicable);
(viii)
the name and daytime phone number of the laboratory
quality assurance officer;
(ix)
the name and daytime phone number of a laboratory contact
person;
(x)
the laboratory hours of operation;
(xi)
fields of testing for which the laboratory is requesting
certification;
(xii)
methods employed including components;
(xiii)
description of laboratory type (for example):
(I)
commercial;
(II)
federal;
(III)
hospital or health care facility;
(IV)
state;
(V)
academic institutes;
(VI)
public water system;
(VII)
public waste water system;
(VIII)
industrial (an industry with a discharge permit);
(IX)
mobile; or
(X)
other (describe).
(xiv)
fee enclosed (if applicable);
(xv)
description of geographical location;
(xvi)
fax number;
(xvii)
lab identification number; and
(xviii)
quality manual;
(B)
be enrolled in a proficiency-testing program and meet all
requirements of paragraph (4) of this subsection;
(C)
pay all fees under §73.22 of this title prior to the
issuance of a certificate:
(i)
out-of-state laboratories that meet requirements through
reciprocity are exempt from category fees;
(ii)
laboratories that use third party assessors to meet the
on-site assessment requirements are exempt from category fees.
(D)
pass an on-site assessment by meeting all requirements
of paragraphs (5) - (7) of this subsection.
(3)
Certification of laboratories outside the State of Texas.
(A)
The department shall certify an out-of-state laboratory
to perform environmental sample analysis provided:
(i)
the laboratory is certified by the EPA or a State Certification
Authority for those fields of testing in which the laboratory is requesting
certification pursuant to this rule;
(ii)
the laboratory submits to the department a completed application,
copies of the laboratory's two most recent proficiency test results, and its
written quality assurance manual;
(iii)
the laboratory submits to the department a copy of its
most recent (less than two years old) on-site assessment report from the EPA
or State Certification Authority together with a current copy of the laboratory's
certification listing the categories, analytes or components, and approved
methods; and
(iv)
the department determines that the out-of-state certification
program is equivalent to the requirements of this rule.
(B)
If upon review of the required documents, the department
determines that the out-of-state certification program is equivalent to the
requirements of this rule, the department will not require an on-site assessment
by its assessors and certification shall be granted after the assessed fees
are paid.
(C)
If upon review of the required documents, the department
determines that the out-of-state certification program is not equivalent or
cannot determine if the out-of-state certification is equivalent to the requirements
of this rule, the department will notify, in writing, the applicable certification
authority and the laboratory. However, the laboratory is to be notified only
in situations where no administrative or judicial prosecution is contemplated.
(D)
If the laboratory's status is changed from certified to
provisionally certified or not certified by the laboratory's primary certification
authority, the laboratory shall notify the department within 30 days of receipt
of notification of the intent to downgrade by the primary certification authority.
(4)
Proficiency testing requirements for certification. For
a laboratory to become certified or to maintain certification for a component
by a specific method, the laboratory shall, at its own expense meet the proficiency
testing requirements of this subsection.
(A)
The laboratory shall enroll and participate in a proficiency
testing program for each component for which it seeks certification. For each
of these components for which proficiency testing is not available, the laboratory
shall establish, maintain, and document the accuracy and reliability of its
procedures through a system of internal quality management.
(B)
The laboratory shall participate in more than one proficiency
testing program if necessary to be evaluated to obtain or maintain approval
to analyze a component.
(C)
The laboratory shall use a proficiency test provider that
is accredited by the National Institute of Standards and Technology.
(D)
The laboratory shall follow the proficiency testing provider's
instructions for preparing the proficiency testing sample and shall analyze
the proficiency testing sample as if it were a client sample.
(E)
The laboratory shall direct the proficiency testing provider
to send, either in hard copy or electronically, a copy of each evaluation
of the laboratory's proficiency testing study results to the department. The
laboratory shall allow the proficiency testing provider to release all information
necessary for the department to assess the laboratory's compliance with this
rule.
(F)
Proficiency testing providers shall evaluate results from
all proficiency testing studies using NELAC-mandated acceptance criteria described
in Chapter 2, Appendix A, of the NELAC standards.
(G)
In each calendar year, the laboratory shall complete at
least two separate proficiency testing studies for each component. The department
may determine the months of participation in the proficiency testing program.
(H)
The laboratory shall be successful in at least one of the
most recent two proficiency testing studies for each field of testing, subgroup,
or component for which it is certified.
(I)
The laboratory shall be successful in at least one proficiency
testing study annually for each SDWA method for which it is certified.
(J)
The certified laboratory shall not:
(i)
discuss the results of a proficiency testing study with
any other laboratory until after the deadline for receipt of results by the
proficiency testing provider;
(ii)
if the laboratory has multiple testing sites or separate
location, discuss the results of a proficiency testing study across sites
or locations until after the deadline for receipt of results by the proficiency
testing provider;
(iii)
send proficiency testing samples or portions of samples
to another laboratory to be tested; or
(iv)
knowingly receive proficiency testing samples from another
laboratory for analysis and fail to notify the department of the receipt of
the other laboratory's sample within five business days of discovery.
(K)
The following are strictly prohibited:
(i)
performing multiple analyses (replicates, duplicates) which
are not normally performed in the course of analysis of routine samples;
(ii)
averaging the results of multiple analyses for reporting
when not specifically required by the method; or
(iii)
permitting anyone other than bona fide laboratory employees
who perform the analyses on a day-to-day basis for the laboratory to participate
in the generation of data or reporting of results.
(L)
The laboratory shall maintain a copy of all proficiency
testing records, including analytical worksheets and proficiency testing provider
report of results.
(5)
On-site assessments for certification.
(A)
The department is authorized to conduct on-site assessments
of the laboratory at any time during normal business hours.
(B)
An on-site assessment shall be conducted prior to the issuance
of a certificate. Thereafter, an on-site assessment shall be conducted every
two years. If the laboratory completes all of the requirements for continued
certification except that of an on-site assessment because the department
is unable to schedule the assessment, the department may issue interim certification
for a period not to exceed six months.
(C)
The laboratory shall ensure that its documented Quality
System, analytical methods, quality control data, proficiency test data, laboratory
standard operating procedures, and other records needed to verify compliance
with this rule are available for review during the on-site laboratory assessment.
The laboratory shall allow the department's authorized personnel to examine
records; observe the laboratory's procedures, facilities, and equipment; and
interview staff as necessary to determine such compliance.
(D)
The department shall issue an assessment report to the
laboratory documenting any deficiencies found by the assessor within 30 calendar
days of the on-site assessment.
(E)
The department shall adopt procedures specifying the application
criteria for acceptance and approval of approved third-party laboratory accreditation
organizations.
(6)
Corrective action reports in response to on-site assessment
for certification.
(A)
A corrective action report must be submitted by the laboratory
to the department in response to any assessment report received by the laboratory
after an on-site assessment. The corrective action report shall include the
action that the laboratory shall implement to correct each deficiency and
the time period required to accomplish the corrective action.
(B)
After being notified of deficiencies, the laboratory shall
have 30 calendar days from the date of receipt of the assessment report to
provide a corrective action report to the department.
(C)
The department shall evaluate the corrective action report
and respond to the laboratory within 30 calendar days of receipt of the report.
(D)
If the corrective action report (or a portion) is deemed
unacceptable to remediate a deficiency, the laboratory shall have an additional
30 calendar days to submit a revised corrective action report.
(E)
If the corrective action report is not acceptable to the
department after the second submittal, certification shall be revoked for
all or any portion of its scope of certification for all or any of a field
of testing, method, or component within a field of testing.
(F)
All information included and documented in an assessment
report and the corrective action report are considered to be public information
with the exception of proprietary data such as: confidential business information
and classified national security information which will be excluded from all
public records.
(G)
If the laboratory fails to implement the corrective actions
as stated in their corrective action report, certification for fields of testing,
specific methods, or components within those fields of testing shall be revoked.
(7)
Method approval for certification.
(A)
A laboratory must request approval to analyze for a component
as part of its application for certification or renewal of certification.
The laboratory must specify the method by which the analysis shall be performed.
Approval to analyze for a component by the specific method shall be granted
only after an on-site assessment. The laboratory shall:
(i)
provide documentation that it has the necessary equipment
and trained technical employees to perform the test;
(ii)
provide documentation that the laboratory has passed two
proficiency testing studies for the component(s) in question;
(iii)
provide its standard operating procedure for the method
used for the component(s) in question;
(iv)
provide documentation of its initial demonstration of
analytical capability; and
(v)
provide documentation establishing the laboratory's method
detection limit for the component.
(B)
At any time a laboratory may request approval to analyze
for additional components or to analyze by additional methods by submitting
a written request together with the documentation required in subparagraph
(A) of this paragraph. The department may require an on-site assessment prior
to the granting of approval.
(C)
SDWA methods of analysis shall be as specified in 40 Code
of Federal Regulations Chapter 141 of the National Primary Drinking Water
Regulation, or by any alternative analytical technique as specified by the
department and approved by the Administrator of the EPA under 40 Code of Federal
Regulations §141.27.
(D)
The department adopts by reference the federal regulations
referred to in subparagraph (C) of this paragraph. These documents are available
for review during normal business hours at the department's Bureau of Laboratories,
1100 West 49th Street, Austin Texas.
(8)
Period of certification.
(A)
The period of certification shall be 24 months from the
date of issuance of the certificate.
(B)
To renew certification, a laboratory shall reapply to the
department and meet all the requirements for certification prior to the termination
of their certification.
(9)
Display of certificate. A current certificate shall be
displayed at all times in a prominent place in each certified laboratory where
it may be viewed by the public.
(10)
Denial and revocations of certification.
(A)
The department is authorized to deny, suspend, limit, or
revoke the certification of any laboratory that does not comply with the requirements
in the EPA's Manual for the Certification of Laboratories Analyzing Drinking
Water, EPA 815-B-97-001, March 1997, and this rule.
(B)
In determining the denial, revocation, suspension, or limitation,
the department shall consider such factors as the gravity of the offense,
the danger the offense poses to the public, the intent of the violation, the
extent of the violation, and the proposed correction of the problem.
(C)
The department is authorized to immediately suspend the
certification of a laboratory when the department determines that any condition
in the laboratory presents a clear and present danger to public health and
safety.
(D)
Any laboratory, which has its certification revoked, denied,
suspended, or limited shall be allowed to apply for a fair hearing conducted
by the department. The technical director or quality assurance officer shall
submit a written request to the department within 30 days of receipt of notice.
The hearing will be conducted using the department's fair hearing procedures
in 25 Texas Administrative Code, Chapter 1, Subchapter C (relating to Fair
Hearing Procedures).
(11)
Changes of name or ownership. A certified laboratory must
notify the department in writing within 30 days of major changes in personnel,
equipment or laboratory location. A major change in personnel is defined as
the loss or replacement of the laboratory supervisor or a situation in which
a trained and experienced analyst is no longer available to analyze a particular
parameter for which certification has been granted.
(f)
Accreditation.
(1)
Standard for accreditation. A laboratory accredited by
the department pursuant to this rule shall comply with the consensus standards
adopted at the National Environmental Laboratory Accreditation Conference
(NELAC). The NELAC Constitution, Bylaws, and Standards, EPA 600/R-99/068,
revised as of June 29, 2000, are adopted by reference into this rule. These
specifications are available for review during normal business hours at the
department's Bureau of Laboratories, 1100 West 49th Street, Austin Texas.
(2)
Fields of Testing. The department will offer accreditation
for analysis performed for compliance purposes with the Safe Drinking Water
Act and the Clean Water Act.
(3)
Accreditation requirements. To become accredited, to renew
accreditation, or to become reaccredited under this rule, a laboratory must
meet all the requirements of the NELAC standard and:
(A)
submit a completed application to the department, on forms
provided by the department that shall include the information required by §§4.1.7.1
and 4.1.7.2 of the NELAC standards;
(B)
be enrolled in a proficiency testing program and meet all
requirements of subsection (5) of this section;
(C)
pay all fees under §73.22 of this title (relating
to Fees) prior to the issuance of accreditation. Out of state laboratories
that meet the requirements through reciprocity are exempt from category fees;
(D)
pass an on-site assessment to determine competence in the
areas listed in §3.6.1 of the NELAC Standard and meet all requirements
of paragraph (6) of this subsection.
(4)
Reciprocity. An out-of-state laboratory shall be eligible
for reciprocal accreditation to perform environmental sample analysis provided
the laboratory is accredited by an agency recognized as a NELAP approved accrediting
authority for those fields of testing in which the laboratory is requesting
accreditation pursuant to this rule.
(A)
To apply for reciprocal accreditation the laboratory shall
submit to the department:
(i)
a completed application;
(ii)
copies of the laboratory's three most recent proficiency
test results;
(iii)
its written quality assurance manual; and
(iv)
a copy of its most recent (less than two years old) on-site
assessment report from the accrediting authority or from the accrediting authority's
delegated assessor body, together with a current copy of the laboratory's
accreditation that lists the categories, analytes, or components , and methods
accredited.
(B)
The department shall review the documentation submitted
by the laboratory and grant reciprocal accreditation in compliance with §6.2.1
of the NELAC standard.
(5)
Proficiency testing requirements for accreditation.
(A)
To be accredited initially and to maintain accreditation
a laboratory must comply with the proficiency testing requirements of §§2.4,
2.5 and 2.7 of the NELAC standard.
(B)
The laboratory shall direct the proficiency testing provider
to send, either in hard copy or electronically, a copy of each evaluation
of the laboratory's proficiency testing study results to the department. The
laboratory shall allow the proficiency testing provider to release all information
necessary for the department to assess the laboratory's compliance with this
rule.
(C)
Proficiency testing providers shall evaluate results from
all proficiency testing studies using NELAC-mandated acceptance criteria described
in Chapter 2, Appendix, C the NELAC standards.
(D)
The laboratory shall maintain a copy of all proficiency
testing records, including analytical worksheets and proficiency testing provider
report of results.
(6)
On-site assessments for accreditation.
(A)
On-site assessments will be conducted by the department
in accordance with the requirements outlined in Chapter 3 the NELAC standard.
(i)
The department is authorized to conduct on-site assessments
of the laboratory at any time during normal business hours.
(ii)
An on-site assessment shall be conducted prior to granting
accreditation. Thereafter, an on-site assessment must be completed at least
every two years. If the laboratory completes all of the requirements for continued
accreditation except that of an on-site assessment because the department
is unable to schedule the assessment, the department may issue interim accreditation
for a period not to exceed six months. Assessments for cause may be conducted
at any time.
(iii)
The department shall adopt procedures specifying the
application criteria for acceptance and approval of third-party laboratory
accreditation organizations to perform the onsite assessment.
(iv)
The department shall issue an assessment report to the
laboratory documenting any deficiencies found by the assessor within 30 calendar
days of the on-site assessment.
(B)
Preparation and evaluation of corrective action reports
in response to on-site assessment shall be in compliance with §4.1.3
of the NELAC standard.
(i)
The laboratory must submit a plan of corrective action
to the department within 30 days of receipt of any assessment report. The
corrective action plan shall include the action that the laboratory shall
implement to correct each deficiency and the time period required to accomplish
the corrective action.
(ii)
The department shall respond to the action noted in the
corrective action report within 30 calendar days of receipt.
(iii)
If the corrective action report (or a portion) is deemed
unacceptable to remediate a deficiency, the laboratory shall have an additional
30 calendar days to submit a revised corrective action report.
(iv)
If the corrective action report is not acceptable to the
department after the second submittal, the laboratory shall have accreditation
revoked pursuant to §4.4.3 of the NELAC standard for all or any portion
of its scope of accreditation for any or all of a field of testing, method,
or component within a field of testing.
(v)
All information included and documented in an assessment
report and the corrective action report are considered to be public information
and are to be released.
(vi)
If the laboratory fails to implement the corrective actions
as stated in their corrective action report, accreditation for fields of testing,
specific methods, or analytes within those fields of testing shall be revoked.
(vii)
Proprietary data, confidential business information and
classified national security information will be excluded from all public
records.
(7)
Awarding of accreditation. The department shall award accreditation
in compliance with §4.6 of the NELAC standard. When the laboratory has
met the requirements specified for receiving accreditation, the laboratory
shall receive a certificate awarded on behalf of the department as the accrediting
authority. The certificate shall be signed by a member of the department and
shall be considered an official document. It will be transmitted as a sealed
and dated (effective date and expiration date) document containing the NELAP
insignia. The certificate shall comply with §4.6 of the NELAC standard
and include:
(A)
name of laboratory;
(B)
address of laboratory;
(C)
fields of testing (program, method, analyte or component);
and
(D)
addenda or attachments (these shall be considered to be
official documents.
(8)
Period of accreditation.
(A)
The period of accreditation shall be 12 months from the
date of issuance.
(B)
To renew accreditation, a laboratory shall reapply to the
department and meet all requirements for accreditation prior to the termination
of their accreditation.
(9)
Display of accreditation. A current accreditation document
shall be displayed at all time in a prominent place in each accredited laboratory
where it may be viewed by the public.
(10)
Denial and revocations of accreditation.
(A)
Pursuant to §4.4 of the NELAC standard, the department
is authorized to deny, suspend, limit, or revoke the accreditation of any
laboratory that does not comply with the requirements in the NELAC Standards
and this rule.
(B)
Any laboratory, which has its accreditation, revoked, denied,
suspended, or limited shall be allowed to apply for a fair hearing conducted
by the department. The technical director or quality assurance officer shall
submit a written request to the department within 30 days of receipt of the
notice. The hearing will be conducted using the department's fair hearing
procedures in 25 Texas Administrative Code, Chapter 1, Subchapter C (relating
to Fair Hearing Procedures).
(11)
Notification and reporting requirements. The accredited
laboratory shall notify the department of any changes in key accreditation
criteria within 30 calendar days of the change. This written notification
includes but is not limited to changes in the laboratory ownership, location,
key personnel and major instrumentation. All such updates are public record
and any or all of the information contained therein may be placed in the national
database.
(12)
Technical Committee.
(A)
The department shall establish one or more technical committees
for the assistance in interpretation of requirements and for advising the
department on the technical matters relating to the operation if its environmental
laboratory accreditation program.
(B)
Appointments to the committee shall be made from lists
of nominees solicited by the department, and shall provide adequate representation
of interested parties and environmental laboratories subject to this rule.
(C)
The department shall determine the terms of office of appointees.
All committee members shall serve without compensation and shall pay their
own expenses incurred as a result of attending meetings or engaging in any
other activity pursuant to this section.
This agency hereby certifies that the adoption
has been reviewed by legal counsel and found to be a valid exercise of the
agency's legal authority.
Filed with the Office of
the Secretary of State on May 25, 2001.
TRD-200102987
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 14, 2001
Proposal publication date: December 1, 2000
For further information, please call: (512) 458-7236