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HomeHealth and Safety CodeDiv. 101Pt. 1Ch. 4Art. 3§ 100865 Laboratory Inspection Authority

§ 100865 Laboratory Inspection Authority

Health and Safety Code·California
AI Summary·Official Text·Key Terms·Related Statutes·References
AI SummaryVerified

§ 100865 Laboratory Inspection Authority

This law lets state board officials go into labs that want special certifications, look around, take pictures, and ask for paperwork, and says labs must let them in or lose the certification.

Key Takeaways

  • •State board reps can inspect certified labs, take photos, and copy records.
  • •Labs must give requested reports and records within 15 days of a request.
  • •Refusing entry or trying to stop an inspection is a misdemeanor and can cause the lab to lose its certification or accreditation.

Example

A medical testing lab wants an ELAP certification. An authorized state board representative shows up during business hours and asks to see the lab’s equipment and records.

If the lab says no, the law says the lab will be denied the certification or have it taken away. If the lab tries to block the inspector, the person could be charged with a misdemeanor.

AI-generated — May contain errors. Not legal advice. Always verify source.

Official Source
View on CA.gov

§ 100865 Laboratory Inspection Authority

(a) In order to carry out the purpose of this article, any duly authorized representative of the state board may do the following: (1) Enter and inspect a laboratory that is ELAP certified or TNI accredited pursuant to this article or that has applied for ELAP certification or TNI accreditation. (2) Inspect and photograph any portion of the laboratory, equipment, any activity, or any samples taken, or copy and photograph any records, reports, test results, or other information related solely to certification under this article or regulations adopted pursuant to this article. (3) Require an owner of a laboratory to provide, within 15 days of receiving a request from a duly authorized representative of the state board, reports, test results, and other information required to implement this article, including, but not limited to, applicable standard operating procedures, quality control or quality assurance manuals, quality control or quality assurance data, employee qualifications, training records, or information relating to accreditation with another state or agency. The state board may require a laboratory to conduct proficiency testing in any of the laboratory’s accredited fields of testing. (b) It shall be a misdemeanor for any person to prevent, interfere with, or attempt to impede in any way, any duly authorized representative of the state board from undertaking the activities authorized by this section. (c) If a laboratory that is seeking ELAP certification, TNI accreditation, ELAP recertification, or TNI reaccreditation refuses entry of a duly authorized representative during normal business hours for either an announced or unannounced onsite assessment, the certification, accreditation, recertification, or reaccreditation shall be denied or revoked. (d) Refusal of a request by a TNI approved accrediting authority, the state board, or any employee, agent, or contractor of the state board, for permission to inspect, pursuant to this section, the laboratory and its operations and pertinent records during the hours the laboratory is in operation shall result in denial or revocation of ELAP certification or TNI accreditation. (Amended by Stats. 2017, Ch. 327, Sec. 12. (AB 1438) Effective January 1, 2018.)

Last verified: January 11, 2026

Key Terms

ELAP certificationTNI accreditationduly authorized representativeinspectiondenial or revocation

Related Statutes

  • § 100840 Laboratory Certification Application Requirements
  • § 100850 Laboratory Certification Requirements
  • § 100855 Laboratory Certification Denial Notice
  • § 100910 Laboratory Certification Revocation Process
  • § 100915 Laboratory Certification Suspension

References

  • Official text at leginfo.legislature.ca.gov
  • California Legislature. Health and Safety Code. Section 100865.
View Official Source