HDC Laboratory Registration
Registration Process
- Complete and submit an application form here. Applications will be processed in the order received.
- Once an application has been processed, an email will be sent to the email address provided on the application. This email will prompt the applicant to log into TDA’s secure portal and upload required documents. Please submit all documents at the same time. See required documents listed below.
- Once all required documents are uploaded to TDA’s secure portal, TDA will review the documents for final approval. If TDA has questions about the documents provided, the applicant will be contacted.
- With final approval of documents, an email will be sent to the email address provided on the application. The email will provide notification of the specific testing that the laboratory has been approved for registration.
- A certificate of registration will be sent to the email address provided on the application.
Documents Required for Laboratory Registration
1. Certificate and Scope of Accreditation
* May be a single document
* Accreditation must be active/unexpired
* Accrediting body must be an ILAC signatory
* Both fixed and flexible scopes of accreditation are acceptable
* The laboratory’s name and address must match the name and address on the application
2. Example Certificate(s) of Analysis (COA)
* This may also be referred to as a test report
* A mock COA is acceptable for the application process; actual client information need not be submitted for the review
* Results must be included for each analyte requested on the application
* Multiple example COAs may be submitted to cover the full scope of approval being requested
* Reference Tenn. Comp. R. & Regs. 0080-10-02 for additional requirements
* Subcontracting or send-out testing is a common and permissible laboratory practice. If a laboratory elects to subcontract one or more testing categories, data generated by the subcontractor may be included on the COA, provided that the following conditions are met:
-- Subcontracted test results are clearly identified as such
--The laboratory or laboratories performing the subcontracted testing are approved separately by the Department for the work performed; the laboratory sending out the samples for subcontracted testing may or may not be independently approved for the subcontracted testing
-- The laboratory or laboratories performing the subcontracted testing are clearly identified, per result, by name and address, which must match exactly with what is on file with the Department
3. Additional Information
* Scopes of accreditation will also be reviewed for the following:
-- Listing of specific analytes (e.g., mercury, aflatoxin B1, and Salmonella spp.)
-- Limits of quantitation or detection, as appropriate
* In cases where the above listing of specific analytes and limits are not clearly stated on the scope of accreditation, the uploading of additional information will be required to address each one. As accrediting bodies utilize different formats for their scopes of accreditation, the additional information uploaded is expected to vary by laboratory. However, documents included in validation/verification data packages that would ordinarily be provided to a laboratory’s accrediting body will likely contain most, if not all, of the necessary information. Data package elements may include, but are not limited to, standard operating procedures, analyst worksheets, instrument parameters, instrument response (e.g., chromatograms and calibration curves), control data/control charts, and proficiency testing records.
* For laboratories with fixed scopes of accreditation, the review process will only consider specific analytes and limits of quantitation/detection when those are clearly stated on the scope of accreditation. For example, if specific pesticides are enumerated on the scope of accreditation (rather than a broader “pesticides” category), all pesticides required by Tenn. Comp. R. & Regs. 0080-10-02-.05 must be listed on the scope. In these cases, laboratories are expected to work with their accrediting body to address the laboratory’s needs prior to approval. A formal memo on letterhead from a laboratory’s accrediting body may be sufficient to clarify ambiguities.