§ 100850 Laboratory Certification Requirements

This law says a state board gives a lab a certificate when it applies and follows all the rules, can take the certificate away if the lab messes up things like test samples or an onsite check, and can give a short‑term certificate while waiting for the full check, but only for up to a year.

Key Takeaways

•A lab gets certification only after the board finds it fully follows the article and its regulations.
•The board can deny or revoke a certificate if the lab fails proficiency testing, doesn’t do the tests, uses another lab’s results, fails the onsite check, or breaks any other rule.
•The board may give a temporary (interim) certificate while waiting for the onsite check; it lasts no longer than one year and can’t be renewed.

Example

A medical testing lab applies for certification, passes its proficiency‑testing samples, and gets a site visit that goes well, so the board issues a certificate. Later the lab submits test results that actually came from another lab, so the board revokes the certificate.

The lab first got a certificate because it followed all the steps. When it broke the rule about using its own test results, the board used the law to take the certificate away.

(a) Upon the filing of an application for ELAP certification or TNI accreditation and after a finding by the state board that there is full compliance with this article and regulations adopted under this article, the state board shall issue to the owner certification or accreditation in the fields of testing for which the laboratory is seeking certification and with respect to which the state board has determined there is full compliance. (b) The state board shall deny or revoke a certificate if it finds any of the following: (1) The laboratory fails to report acceptable results in the analysis of proficiency testing samples. (2) The laboratory fails to analyze proficiency testing samples. (3) The laboratory submits, as its own, proficiency testing sample results generated by another laboratory. (4) The laboratory fails to pass an onsite assessment. (5) The laboratory is not in compliance with any other provision of this article or regulations adopted under this article. (c) Upon the filing of a complete application for certification or accreditation pursuant to subdivision (a) and Section 100870, the state board may issue to a laboratory interim certification or accreditation pending the completion of onsite assessment. Interim certification and accreditation shall be nonrenewable and shall remain in effect until certification and accreditation is either granted under subdivision (a) or denied under subdivision (b), but not later than one year after the date of issuance. (Amended by Stats. 2017, Ch. 327, Sec. 6. (AB 1438) Effective January 1, 2018.)

Key Takeaways

•A lab gets certification only after the board finds it fully follows the article and its regulations.
•The board can deny or revoke a certificate if the lab fails proficiency testing, doesn’t do the tests, uses another lab’s results, fails the onsite check, or breaks any other rule.
•The board may give a temporary (interim) certificate while waiting for the onsite check; it lasts no longer than one year and can’t be renewed.

Example

The lab first got a certificate because it followed all the steps. When it broke the rule about using its own test results, the board used the law to take the certificate away.

Key Takeaways

Example

Key Terms

References

§ 100850 Laboratory Certification Requirements

Key Takeaways

Example

Key Terms

References

Key Takeaways

Example

Key Terms

Related Statutes

References

Key Takeaways

Example

Key Terms

Related Statutes

References