La. Admin. Code tit. 51 § IX-133

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

Section IX-133 - Requirements for Laboratory Certification [formerly paragraph 9:002-16]

A. The laboratory and laboratory analysts are required to receive a satisfactory evaluation during an on-site visit by the shellfish evaluation officer for the state of Louisiana or FDA laboratory evaluation officer in order to be certified.

1. The purpose of the evaluation will be to assure the uniform application of standard procedures and methods in the sampling and analytical examination of shellfish growing waters and to determine and assure the adequacy of facilities, equipment and personnel to perform analytical testing necessary to meet the requirements recommended by the National Shellfish Sanitation Program and found to be acceptable by the Louisiana Molluscan Shellfish Program, administered by the Department of Health, Office of Public Health. Evaluation is not an endorsement of the laboratory facility, its staff the operation as this implies continuing guarantee of performance.

2. A satisfactory rating is achieved by demonstration during an on-site evaluation that the laboratory and laboratory personnel are found to conform or conditionally conform with all requirements as listed in the Shellfish Laboratory Evaluation Check Lists provided by the Federal Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, Shellfish Aquaculture and Policy Branch. A satisfactory rating indicates that FDA recognizes that the laboratory complies with recommended procedures and capabilities and that the analytical results produced by the laboratory are in support of the Louisiana Shellfish Sanitation Program and are acceptable to FDA.

3. No reference shall be made in any advertising or sales promotion which would indicate or imply that the Louisiana state shellfish evaluation officer or FDA laboratory evaluation officer evaluated this laboratory or approves, endorses or recommends any proprietary materials, services, or publications mentioned herein or which has as its purpose and intent to cause directly or indirectly the advertised materials or services to be used or purchased because of the evaluation.

B. An applicable, currently dated (i.e., the last satisfactory on-site evaluation shall be documented to have been held within the prior three year period) satisfactory FDA Shellfish Standard Laboratory Evaluation Form and narrative report submitted by the appropriate laboratory evaluation officer to the FDA Division of Cooperative Programs, Shellfish Sanitation Branch with a copy to the appropriate FDA shellfish specialist and the public health laboratory director shall be on file or available upon request.

1. Said narrative report shall include the identity of the laboratory, the date of evaluation, name of evaluator, information on personnel and procedures and conclusions and shall precisely and accurately describe the conditions which existed during the evaluation, including what recommendations were made to correct deficiencies and proposed timetable for any corrective action necessary to bring the laboratory into substantial conformity with the requirements of NSSP as approved by the Louisiana State Shellfish Sanitation Program.

2. If any deficiencies or recommendations were noted in the narrative report, the laboratory shall demonstrate that the stated deficiencies and/or recommendations have been satisfactorily corrected or addressed within the proposed timetable and that the laboratory is substantially in compliance with the requirements of NSSP as approved by the Louisiana state Sanitation Program.

3. Failure to be found to conform or provisionally conform during the on-site evaluation by the appropriate Laboratory Evaluation Officer and/or failure to correct or address deficiencies or recommendations as noted in the narrative report within the stated timetable shall result in loss of satisfactory evaluation.

C. As samples are available, the laboratory shall periodically participate in a split-sample program to test laboratory proficiency and shall receive a grade of satisfactory.

1. Refusal to participate and/or repeated failure to receive a satisfactory grade shall result in loss of satisfactory evaluation.

D. The laboratory shall maintain a list of qualified analysts who have received a satisfactory rating as a result of the evaluation procedures and who are consequently approved to conduct analysis in the laboratory.

La. Admin. Code tit. 51, § IX-133

Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 28:1299 (June 2002), Amended by the Department of Health, Office of Public Health, LR 481849 (7/1/2022), Amended LR 482138 (8/1/2022).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:4.A.(1), R.S. 40:5.A.(2)(3)(5)(7)(9)(15)(17)(19)(20) and R.S. 40:5.3.