La. Admin. Code tit. 48 § V-8033

Current through Register Vol. 50, No. 11, November 20, 2024

Section V-8033 - On-Site Assessment

A. The department will perform an initial on-site assessment of an environmental laboratory seeking certification, except as provided in §8017, prior to granting certification, and reassessments at intervals of three years and at such other times as the department deems necessary to determine continued compliance to this rule. All assessments performed by the department shall be pursuant to the USEPA Manual for the Certification of Laboratories Analyzing Drinking Water.

B. The department may conduct announced or unannounced on-site assessments of an environmental laboratory to ensure compliance with this Chapter or orders issued by the department at any time.

C. The laboratory shall ensure that records including its quality manual, analytical methods, standard operating procedures, quality assurance/quality control data, proficiency testing data, and all records needed to verify compliance to the federal Safe Drinking Water Act (42 USC 300f et seq.) and its implementing regulations (40 CFR Parts 141 and 143); the Louisiana State Sanitary Code (LAC 51) and this rule are available for review during the on-site assessment. The laboratory shall allow the department's authorized personnel to examine records, observe laboratory procedures, facilities, equipment and to interview staff during the on-site assessment.

D. The department will provide the laboratory with a written assessment report documenting any findings found by the department, observations documenting competence and conformity, within 30 calendar days of the last day of the assessment.

E. The laboratory shall submit a corrective action plan to the department within 30 calendar days from receipt of the on-site assessment report from the department where the department has found deficiencies. The corrective action plan shall document the corrective action taken by the laboratory to correct each deficiency.

F. In addition to on-site assessments, the department shall perform other surveillance activities to monitor certified laboratories' continued compliance to the provisions of this Chapter throughout the period of certification. Annually, the department shall review among other things, proficiency testing, internal audits, corrective action reports and any other certification-related laboratory records the department deems appropriate to establish continued compliance to the provisions of this Chapter.

G. Nothing in this Section shall be construed as requiring the department to reassess a laboratory prior to taking a regulatory or administrative action affecting the status of the laboratory's certification. Nothing in this Section shall be construed as limiting in anyway the department's ability to revoke or otherwise limit a laboratory's certification upon the identification of such deficiencies as to warrant such action.

H. Copies of all assessment reports, checklists, and laboratory responses shall be retained by the department for a period of at least 10 years, or longer if required by specific State or Federal regulations.

La. Admin. Code tit. 48, § V-8033

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 38:3220 (December 2012), Amended by the Department of Health, Office of Public Health, LR 461094 (8/1/2020).

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