Louisiana Administrative Code
Title 48 - PUBLIC HEALTH-GENERAL
Part V - Preventive Health Services
Subpart 28 - Drinking Water Laboratories
Chapter 80 - Certification of Laboratories Performing Drinking Water Analyses
Subchapter B - Program Procedures and Requirements
Section V-8039 - Denial, Suspension, Revocation and Voluntary Withdrawal of Certification
Universal Citation: LA Admin Code V-8039
Current through Register Vol. 50, No. 9, September 20, 2024
A. Denial of Certification. Denial means to refuse to certify in part or in total a laboratory applying for initial certification or resubmission of initial application.
1. Reasons to deny an initial
application may include:
a. failure to submit
a completed application;
b. failure
of laboratory staff to meet the personnel qualifications as required by the
USEPA Manual for the Certification of Laboratories Analyzing Drinking Water.
These qualifications include, but are not limited to, education, training and
experience requirements;
c. failure
to successfully analyze and report PT samples as required in the USEPA Manual
for the Certification of Laboratories Analyzing Drinking Water;
d. failure to attest that analyses are
performed by methodologies as required in 40 CFR Parts 141 and 143 for the
analysis of drinking water parameters;
e. failure to implement a quality system as
defined in the USEPA Manual for the Certification of Laboratories Analyzing
Drinking Water;
f. failure to
respond to a deficiency report from the on-site assessment with a corrective
action report within 30 calendar days after receipt of the assessment
report;
g. failure to implement the
corrective actions detailed in the corrective action report within the
specified time frame as required by the department;
h. failure to pay required fees;
i. failure to pass required on-site
assessment(s) as specified in
§8033 of this Chapter ;
j. misrepresentation of any material fact
pertinent to receiving or maintaining certification; or
k. denial of entry during normal business
hours for an on-site assessment as mentioned under
§8033.B of this Chapter.
2. A laboratory shall
have two opportunities to correct the areas of deficiencies which results in a
denial of certification.
3. If the
laboratory is not successful in correcting the deficiencies as required by
§8033 of this Chapter, the laboratory must
wait 6 months before again reapplying for certification.
4. Upon reapplication, the laboratory shall
be responsible for all or part of the fees incurred as part of the initial
application for certification.
5.
No laboratory's certification will be denied without the right to due process.
The laboratory has a right to an administrative hearing thereon, if requested
in writing within 20 days of receipt of the denial letter. Said administrative
hearing shall be held before an Administrative Law Judge and in accordance with
the Louisiana Administrative Procedure Act (R.S.
49:950 et seq.).
B. Suspension of Certification. Suspension means the temporary removal of a laboratory's certification for a defined period of time which shall not exceed 6 months. The purpose of suspension is to allow a laboratory time to correct deficiencies or areas of non-compliance with this Chapter.
1. A laboratory's certification
may be suspended in part or in total. The laboratory shall retain those areas
of certification where it continues to meet the requirements of this
Chapter.
2. Reasons for suspension
may include:
a. the department finds during
the on-site assessment that the public interest, safety or welfare requires
emergency action;
b. failure to
successfully complete PT studies and maintain a history of at least two
successful PT studies for each affected certified field of testing out of the
most recent three PT studies;
c.
failure to notify the certification body of any changes in key certification
criteria, as set forth in
§8029 of this Chapter;
d. failure to maintain a quality system as
defined in
§8037 of this Chapter; or
e. failure of the laboratory to employ staff
who meet the personnel qualifications including, but not limited to, education,
training and experience as required by this Chapter.
3. A laboratory under suspension will not
have to reapply for certification if the cause/causes for suspension are
corrected within 6 months. The laboratory's suspended certification status will
change to certified when the laboratory complies with this Chapter.
4. A suspended laboratory:
a. cannot continue to analyze samples for the
affected fields of testing for which it holds certification; and
b. shall remain suspended (without appeal
rights) due to unacceptable proficiency testing sample results.
5. If the laboratory is unable to
correct the reason for the suspension, the laboratory's certification shall be
revoked in total or in part within 6 months after the effective date of the
suspension.
6. No laboratory's
certification will be suspended without the right to due process. The
laboratory has a right to an administrative hearing thereon, if requested in
writing within 20 days of receipt of the suspension order. Said administrative
hearing shall be held before an Administrative Law Judge and in accordance with
the Louisiana Administrative Procedure Act (R.S.49:950 et seq.)
C. Revocation of Certification. Revocation means partial or total withdrawal of a laboratory's certification by the department.
1. The department's
Laboratory Services Section shall revoke a laboratory's certification, in part
or in total, for failure to correct the deficiencies after certification had
been suspended. The laboratory shall retain those areas of certification where
it continues to meet the requirements of this Chapter.
2. Reasons for revocation, in part or in
total, include a laboratory's:
a. failure to
submit an acceptable corrective action report in response to a deficiency
report and failure to implement corrective action(s) related to any
deficiencies found during a laboratory assessment(the laboratory may submit two
corrective actions plans within the time limits specified by the department);
or
b. failure to correctly analyze
a parameter(s) in three consecutive PT studies. Should this occur, the
laboratory's certification shall be revoked for each affected certified field
of testing(s), method(s) and analyte(s).
3. Reasons for total revocation include a
laboratory's:
a. failure to respond with a
corrective action report within the required 30 calendar days;
b. failure to participate in the PT program
as required by
§8031 of this Chapter;
c. submittal of PT sample results generated
by another laboratory as its own;
d. misrepresentation of any material fact
pertinent to receiving or maintaining certification;
e. denial of entry during normal business
hours for an on-site assessment as required by
§8033 of this Chapter;
f. conviction of charges for the
falsification of any report of or relating to a laboratory analysis;
or
g. failure to remit the
certification fees within the time limit as established by the department may
be grounds for immediate revocation.
4. After correcting the reason/cause for
revocation, the laboratory may reapply for certification no sooner than six
months from the official date of revocation.
5. No laboratory's certification will be
revoked without the right to due process. The laboratory has a right to an
administrative hearing thereon, if requested in writing within 20 days of
receipt of the revocation order. Said administrative hearing shall be held
before an Administrative Law Judge and in accordance with the Louisiana
Administrative Procedure Act (R.S. 49:950 et seq.).
D. Voluntary Withdrawal of Certification. If an environmental laboratory wishes to withdraw from the laboratory certification program, it must submit written notification to the department no later than 30 calendar days before the end of the certification year.
AUTHORITY NOTE: Promulgated in accordance with R.S. 36:254(B)(7).
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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