La. Admin. Code tit. 48 § V-8035
Current through Register Vol. 50, No. 9, September 20, 2024
Section V-8035 - Issuance and Display of Certificate and Use of CertificationA. The department will issue a certificate to each laboratory meeting the requirements of this Chapter indicating that the laboratory is certified by the department. The numbered certificate will be signed by a laboratory director, or assistant laboratory director, of the department's Laboratory Services Section and the designated laboratory certification staff personnel and will be considered an official document. It will be transmitted as a sealed and dated (effective date and expiration date) document and contain the certification logo. Addenda or attachments to the certificate shall be considered official documents. Information on the addenda or attachments shall include the matrix, fields of certification, methods, analyte/analyte group and technologies.
1. The certified laboratory shall display their most recent certificate in a prominent place in the laboratory, visible to the public. The certificate shall include the certification status of the laboratory and a list all fields of testing for which the laboratory is certified.B. A certified laboratory must not use its certificate, certification status and/or certification logo to imply, either orally or in any literature, endorsement of the laboratory by the state of Louisiana or the department. A certified laboratory must not make any inaccurate statements concerning their fields of certification and certification status.C. A certified laboratory's certification number or other identifier shall be included when the certification body's name is used on general literature such as catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical reports or other material.D. The laboratory must distinguish between proposed testing for which the laboratory is certified and the proposed testing for which the laboratory is not certified.E. The laboratory must return to the department any revoked certification certificate(s) and must discontinue use of all catalogs, advertising, business solicitations, proposals, quotations, laboratory analytical results or other materials that contain reference to their past certification status and/or display their past certification logo.F. The department shall take suitable actions including, but not limited to, legal action when incorrect references to the certification body's certification, misleading use of the laboratory's certification status and/or unauthorized use of the certification logo is found in catalogs, advertisements, business solicitations, proposals, quotations, laboratory analytical reports or other materials. All reports of questionable laboratory practices must be reported to the department's laboratory director, or assistant laboratory director, and to the department's laboratory certification program manager. The department's laboratory certification program manager shall investigate the merits of the report and forward the findings to the department's laboratory director, or assistant laboratory director. If it is determined that a formal investigation is needed, the department's laboratory director, or assistant laboratory director, shall contact the Bureau of Legal Services within the Department of Health (LDH) for guidance and assistance in the investigation. If the investigation determines that action is merited, the laboratory shall be issued a revocation order via certified mail revoking the laboratory's certification. All legal actions taken by the department shall proceed in accordance with the Louisiana Administrative Procedure Act (R.S. 49:950 et seq.) and under the direction of LDH's Bureau of Legal Services. No laboratory's certification shall 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 hearing shall be held before an Administrative Law Judge and in accordance with the Louisiana Administrative Procedure Act (R.S. 49:950 et seq.) All documents related to the investigation(s), including the final disposition, shall be retained by the department for 10 years from the date of such final disposition.G. Certification may be transferred when the legal status or ownership of a certified laboratory changes without affecting its staff, equipment, and organization. The department may conduct an on-site assessment to verify the effects, if any, of such changes on laboratory performance.H. The following conditions apply to the change in ownership and/or the change in location of a laboratory, as well as to a change in top management, key personnel, resources, or premises that is, or previously was, certified by the department under a previous owner and/or at a previous location. 1. In the event there are any changes in the name, location, ownership, top management, key personnel, main polices, resources or premises of a certified laboratory to which the provisions of this Chapter apply, written notice thereof shall be made within 30 days to the entity below: Laboratory Certification Program
Laboratory Services
Department of Health,
Office of Public Health
1209 Leesville Avenue
Baton Rouge, LA 70802
2. The department shall evaluate the significance of any change that might alter or impair the laboratory's capability and quality, and indicate to the affected laboratory the results of the evaluation in writing. The department shall retain records to indicate that such an evaluation was conducted.3. A change in ownership and/or location will not necessarily require recertification or reapplication in any or all of the categories in which the laboratory is currently certified.4. A change in ownership and/or location may require an on-site assessment with the elements of the assessment being determined by the assessor.5. Any change in ownership shall assure historical traceability of the laboratory certification number(s).6. For a change in ownership, the following additional conditions shall be in effect. a. The previous owner (transferor) shall agree in writing, before the transfer of ownership takes place, to be accountable and liable for any analyses, data and reports generated up to the time of legal transfer of ownership.b. The buyer (transferee) must agree in writing to be accountable and liable for any analyses, data and reports generated after the legal transfer of ownership occurs.c. All records and analyses performed pertaining to certification shall be kept for a minimum of 10 years and are subject to review and inspection by the department during this period without prior notification to the laboratory. This stipulation is applicable regardless of change in ownership, accountability or liability.d. If ownership is transferred, the transferee shall not be responsible for payment of fees to the department during the remainder of the calendar year, provided that the previous owner has fully paid the required fees to the department.La. Admin. Code tit. 48, § V-8035
Promulgated by the Department of Health and Hospitals, Office of Public Health, LR 38:3221 (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).