La. Admin. Code tit. 48 § V-8039

Current through Register Vol. 50, No. 9, September 20, 2024

Section V-8039 - Denial, Suspension, Revocation and Voluntary Withdrawal of Certification

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.

La. Admin. Code tit. 48, § V-8039

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 38:3222 (December 2012), Amended by the Department of Health, Office of Public Health, LR 461095 (8/1/2020).

AUTHORITY NOTE: Promulgated in accordance with R.S. 36:254(B)(7).