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Frequently Asked Questions

ORELAP Frequently Asked Questions and Answers

The TNI Standard is a document outlining requirements for accreditation of environmental laboratories. It was developed by The NELAC Institute (TNI), a non-profit consensus standard development body with a goal of creating a national accreditation program for environmental laboratories. ORELAP is one of several state accreditation bodies involved in the development of standards for environmental laboratory accreditation. ORELAP uses the TNI Standard to evaluate a laboratory’s ability to generate data of known and documented quality. ORELAP will not accredit a laboratory that does not comply with the TNI Standard.

As of Jan. 1, 2021, ORELAP uses the 2016 TNI Standard to assess laboratories. A copy of the 2016 TNI Standard can be purchased at https://nelac-institute.org/content/CSDP/standards.php.

​A list of Cannabis fields of accreditation can be found on the “Cannabis Testing” page on the ORELAP website. These are currently the analytes a Cannabis laboratory can be accredited for. 

A list of psilocybin fields of accreditation can be found on the “Psilocybin Testing” page on the ORELAP website. These are currently the analytes a psilocybin laboratory can be accredited for. 

Environmental laboratories can be accredited for a wide range of analytes, including emerging pollutants. A complete list of analytes that ORELAP currently accredits for can be found in the ORELAP Data Input and Edit (ODIE) system. Please be aware ORELAP may be phasing out certain analytes, adding new analytes, or changing analyte names or codes as new information becomes available. If you cannot find a specific analyte in ODIE, first check to see if the analyte can be found in TNI’s National Laboratory Accreditation Management system (LAMs).

If the analyte is found in LAMs, please contact ORELAP at ORELAP.info@odhsoha.oregon.gov with a request to add the analyte to ODIE. Be sure to provide the TNI Analyte Code in your request. 

If the analyte is not found in LAMs, submit a request to TNI to add the analyte using the “Request Analyte Code” link on the TNI LAMs webpage. Then contact ORELAP at ORELAP.info@odhsoha.oregon.gov when you have received notification from TNI the analyte has been added to LAMs. Please provide the TNI Analyte Code in your request. 

ORELAP invoices should be paid by check when possible. Depending on how quickly the check can be generated it can be faster, in some cases, to pay by check through the mail. If you need to pay by credit card, forward the invoice email you received with the invoice attached to ORELAP.info@odhsoha.oregon.gov and request an account receivable be set up for online payment. An accounts receivable allows the laboratory to pay an invoice by credit card via a weblink.

Once your completed application has been submitted online through the ORELAP Data Input and Edit (ODIE) system, ORELAP can begin its review. ORELAP staff will review your requested fields of accreditation for accuracy. Submitted documents are checked for completeness and agreement with program requirements. The steps below will help the process move efficiently. 

1. The following documents must be submitted electronically in ODIE: a signed copy of the certification of compliance, a quality manual, standard operating procedures (SOPs), technical director credentials (i.e., resume and transcripts), applicable demonstrations of capability (DOCs) and method detection limits (MDLs). These documents can be submitted in the window that opens when you click the “Complete Application” button. The file size limit for uploading a document is 10 megabytes. Contact ORELAP staff for larger file sizes. 

2. Make sure you have completed two proficiency testing (PT) samples for each analyte found on The NELAC Institute’s (TNI) Fields of Proficiency Testing (FoPT) tables, and for each Cannabis analyte. PT reports must be sent directly from the PT vendor to ORELAP.PT@odhsoha.oregon.gov. Most, if not all, PT vendors will allow you to select which agency you send PT reports to when you report the results. For ORELAP, select “Oregon," “ORELAP," “Oregon State Public Health Laboratory” or other similar name to ensure we receive them. ORELAP cannot accept any PT report directly from the laboratory. 

3. The 2016 TNI Standard is your source for regulatory requirements and how to qualify for and maintain accreditation under the National Environmental Laboratory Accreditation Program (NELAP). The standard can be purchase from TNI at http://nelac-institute.org/content/CSDP/standards.php?ap3=1_2. Use the 2016 TNI Standard to conduct an internal audit of your laboratory as an indicator of readiness. A checklist for the 2016 TNI Page 2 of 2 Standard can be downloaded at http://nelac-institute.org/content/NELAP/qscheck2016-access.php. Do not schedule an onsite assessment with ORELAP prior to performing an internal audit of your laboratory. The onsite assessment will determine whether your laboratory meets the standards for accreditation and can become accredited, it is not the time for correcting major deficiencies. 

4. Upon an initial review of the completed application, an invoice will be emailed to the laboratory. Payment is made by check. Please include your ORELAP ID number and the invoice number on the memo line for easier tracking. If you cannot pay by check, contact ORELAP staff for alternatives. An onsite assessment cannot be performed prior to payment of an invoice. Late or missing payment is the most common delay in the process. 

5. Following payment, a more thorough desk review and review of PT performance is conducted. Any issues will be communicated to the laboratory for correction. 

6. Once desk review is finished, an onsite assessment will be scheduled with the laboratory for a mutually agreeable time. Assessments are scheduled for 1-5 days depending on the scope of the testing. 

7. Within 30 calendar days after the end of the onsite assessment, ORELAP will provide an assessment report to the laboratory. The report will document any findings identified during the onsite assessment requiring corrective action from the laboratory. The laboratory must respond to these findings within 30 calendar days with a corrective action plan. ORELAP will review the corrective action plan and respond within 30 calendar days, indicating whether the corrective actions are acceptable or unacceptable. If any corrective actions are unacceptable, the laboratory must respond within 30 calendar days of ORELAP’s response. This will be the laboratory’s last chance to submit an appropriate corrective action plan. Not responding within 30 calendar days may result in denial of the laboratory’s application. All of this takes place in the ODIE system online. 

8. Once the assessment report findings have acceptable corrective actions, the assessment is closed, and the laboratory is issued an accreditation certificate

The fees for accreditation can be found in our administrative rules, at OAR 333-064- 0060. A laboratory seeking primary accreditation must pay an application fee every year and an assessment fee every other year. Laboratories seeking secondary (i.e., reciprocal) accreditation must pay only the application fee. Out-of-state laboratories must also pay all travel expenses associated with performing assessments.