26.08.05.13

.13 Laboratory Certification Denial, Provisional Certification, and Revocation of Certification.

A. Denial of Initial Certification.

(1) The Department may deny initial certification to a water quality laboratory for any of the following reasons:

(a) Failure to comply with the minimum standards and qualifications required by this chapter;

(b) Failure to participate in or analyze proficiency test samples;

(c) Submittal of another water quality laboratory’s results for proficiency tests;

(d) Intentionally false statements made on the application forms or any document associated with the certification application;

(e) Conviction of any violation of the laws of Maryland related to water quality;

(f) Fraudulently or deceptively obtaining or attempting to obtain a certification;

(g) Failure to pay the prescribed certification fees; or

(h) Failure to submit or complete acceptable corrective actions to an on-site evaluation.

(2) The denial of initial certification because a water quality laboratory does not satisfactorily meet certification criteria is not appealable.

B. Provisional Certification.

(1) The Department may downgrade a certification of a water quality laboratory for any of the following reasons:

(a) Violation of any provision of this chapter;

(b) Failure to report compliance data in accordance with COMAR 26.04.01 to the public water system or the Department in a timely manner, thereby preventing compliance with federal or State regulations or endangering public health;

(c) Failure to participate in or analyze proficiency test samples in a timely manner;

(d) Failure to report a change in ownership, management, location of facilities, or name of a water quality laboratory within a period of 30 days after the change has occurred; or

(e) Failure to submit or complete acceptable corrective actions to an on-site evaluation.

(2) Procedure for Downgrading Laboratory Status to Provisional.

(a) If a laboratory is subject to downgrading on the basis of criteria in §B of this regulation, the Certification Authority shall notify the laboratory director or owner by certified mail of its intent to downgrade within 30 days from becoming aware of the situation warranting downgrading.

(b) The laboratory director shall send a written response to the Certification Authority within 30 days of receipt of the letter specifying what immediate corrective actions are being taken and any proposed corrective actions that need the concurrence of the Certification Authority.

(c) The Certification Authority shall notify the laboratory in writing, by certified mail, within 14 days of receipt of the laboratory’s response whether the corrective action taken is adequate or if the laboratory is being downgraded to provisionally certified status.

(d) Provisionally certified status may not exceed 90 days.

(3) Testing Under Provisional Certification.

(a) If the Certification Authority determines that the laboratory results are reliable, a provisionally certified laboratory may analyze drinking water samples for compliance purposes.

(b) The laboratory shall notify its clients of its downgraded status in writing on any report.

C. Revocation of Certification for the Water Quality Laboratory.

(1) The Department may revoke certification to a water quality laboratory for one or more of the following reasons:

(a) Failure to comply with the minimum standards and qualifications required by this chapter;

(b) Failure to participate in or analyze proficiency test samples, or to obtain acceptable laboratory results of tests required on the samples annually;

(c) Operation in such a manner as to endanger the public health or safety;

(d) Intentionally false statements made on the application forms or any document associated with certification;

(e) Fraudulence, deliberate falsification, or misrepresentation of federal and State laws when reporting test results;

(f) Conviction of any violation of the laws of Maryland related to water quality laboratories or public drinking water systems;

(g) Documentation of repeated episodes of unethical conduct of water quality laboratory operation;

(h) Failure to pay the prescribed fees associated with certification or renewal of certification;

(i) Fraudulent or deceptive use of a certification;

(j) Fraudulently or deceptively obtaining or attempting to obtain a certification;

(k) Submittal of another water quality laboratory’s results for proficiency tests; or

(l) Failure to implement corrective actions to an on-site evaluation.

(2) Procedure for Revocation.

(a) The Certification Authority shall notify the laboratory, by certified mail, of the intent to revoke certification. The notification shall state the reasons that the laboratory’s certification is being revoked and set forth corrective actions when applicable.

(b) The laboratory shall have 30 days from receipt of the notice of intent to revoke to submit documentation that shows the decision does not meet the criteria in this section. The documentation and a letter of explanation shall be sent by certified mail to the attention of the certification officer.

(c) If the laboratory has not responded within 30 days of the notification of the intent to revoke the certification, the Certification Authority may issue a notice of revocation. A copy of the Department’s judicial review process shall be included with each notice of revocation.

(d) If the laboratory provides documentation and an explanation within the required time, the Certification Authority shall review the submission and determine whether to proceed with revocation.

(e) Within 30 days of receipt of the laboratory’s submission, the Certification Authority shall notify the laboratory either that the documentation is satisfactory to address the reasons for revocation or that certification is revoked.

(f) If the Certification Authority determines after review of the laboratory’s submission to revoke the certification, the revocation date may not be sooner than 30 days from the Certification Authority’s notification to the laboratory. A copy of the Department’s judicial review process shall be included with each notice of revocation.

(3) Upon revocation:

(a) A water quality laboratory shall return its certificate and parameter list; and

(b) A water quality laboratory may not analyze drinking water samples for compliance.

D. Request for Reinstatement of Certification.

(1) Revoked Certification. Through a written request, a laboratory may seek reinstatement of certification if a laboratory can demonstrate to the Certification Authority’s satisfaction that the deficiencies which resulted in revocation have been corrected. The Certification Authority may require an on-site evaluation, successful analysis of unknown samples, or other measures before determining that a laboratory’s certification should be reinstated.

(2) Expired Certification. If a water quality laboratory demonstrates that it meets all renewal requirements, the Department may reinstate the certification of the water quality laboratory.