California's Clinical Laboratory Registration for Waived Tests

In most states a practice running rapid strep and A1c tests needs one thing: a federal CLIA Certificate of Waiver. California adds a second. Business and Professions Code § 1265(a)(2) says a clinical laboratory "performing clinical laboratory tests or examinations subject to a certificate of waiver or a certificate of provider-performed microscopy under CLIA, shall register with the department." The department is the California Department of Public Health (CDPH), and the work is done by its Laboratory Field Services (LFS) branch. Labs running moderate or high complexity tests need a full state license instead (§ 1265(a)(1)).

There is no physician office exemption. The chapter's exclusions in § 1241(b) cover federal labs, public health labs, forensic-only labs, research and teaching labs that do not use patient results, and a few narrow cases such as caregivers checking a diabetic child's glucose, EMTs and paramedics doing only waived glucose tests under their own Certificate of Waiver, and people testing themselves with over-the-counter kits. A family practice, urgent care center, pharmacy or med spa running waived tests registers.

Who applies, and what does the application contain?

The statute is specific. "Application shall be made by the owners of the laboratory and the laboratory directors prior to its opening" (§ 1265(b)). When the owners are not the directors, the registration "shall be issued jointly to the owners and the laboratory directors," and they are "severally and jointly responsible" for the lab.

The application lists:

• the owners, the laboratory directors, and the lab's name and location;
• each test by name and the total number performed annually, excluding quality control, quality assurance and proficiency testing runs;
• "the tests and the test kits, methodologies, and laboratory equipment used";
• the education, training and experience of the people directing, supervising and performing the testing; and
• for PPM, "the name of the provider or providers performing those tests."

This is a separate filing from the CMS-116, which in California goes to the same branch: CMS lists CDPH Laboratory Field Services, LFSCLIA@cdph.ca.gov and (213) 620-6160, as the State Agency.

How much does California charge?

Section 1300(n) sets the registration fees, as of October 2026:

• Waived tests only: $155 a year.
• PPM only, or waived plus PPM: $235 a year.

Those are on top of the federal fee the lab pays CMS: $248 every two years for a Certificate of Waiver or $297 for PPM, as of October 2026. A site doing moderate or high complexity testing pays a license fee instead, from $335 a year at under 2,001 tests and rising with volume. Labs located outside California also reimburse CDPH's travel costs for any onsite inspection (§ 1300(q)).

Does every location need its own registration?

Yes, with four exceptions in § 1265(d). A separate license or registration "shall be obtained for each laboratory location," except:

1. labs "that are not at a fixed location," such as mobile units, health screening fairs or other temporary testing sites, which may register once for the primary site or home base;
2. not-for-profit or government labs doing limited public health testing (no more than a combination of 15 moderately complex or waived tests), which may hold a single registration, with a $28 fee for each additional location approved under that exception (§ 1300(t));
3. hospital labs in contiguous buildings on one campus under common direction; and
4. "Locations within a single street and city address that are under common ownership," at the owners' discretion.

The fourth exception is California's own. It helps a medical building with two suites under one owner. It does not help a group with clinics at different addresses, which registers each one, just as each needs its own federal certificate. See one certificate per site, and the three exceptions.

Is there a deadline for CDPH to decide?

The statute sets a response rule rather than a deadline for approval: "If the department does not within 60 days after the date of receipt of the application issue a license or registration, it shall state the grounds and reasons for its refusal in writing" (§ 1265(f)). Before issuing anything, the department must be "satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter" and that "the owners and laboratory directors are each of good moral character" (§ 1265(c)). Withdrawing an application after filing does not stop the department from acting on it without its written consent (§ 1265(h)).

A practice adding PPM procedures has one extra step on the application: "If the laboratory is performing tests subject to a provider-performed microscopy certificate, the name of the provider or providers performing those tests shall be included." Hiring a new provider who will run wet mounts is a change to report, not only an HR event.

How do pharmacies register?

Section 1206.6 lets a pharmacy run waived tests if it "obtains a valid CLIA certificate of waiver," "obtains a registration from the department pursuant to Section 1265," and the tests "are performed only by a pharmacist" as part of routine patient assessment under § 4052.4. For CLIA purposes the person directing testing "shall be the pharmacist-in-charge," and § 1265(k) makes the pharmacist-in-charge the "laboratory director" on the state registration. Our post on CLIA certificates for pharmacies covers the federal side.

What can cause a registration to be revoked?

Two rules in § 1265 run on 30-day clocks and both are automatic:

• Major change of director or ownership. A registration "shall be automatically revoked 30 days from a major change of laboratory directorship or ownership." The lab must submit a new application within those 30 days "or cease engaging in clinical laboratory practice" (§ 1265(e)(1)).
• Unreported changes. Owners and directors must notify CDPH in writing "of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory directors within 30 days." Failure to report a director change within 30 days "shall result in the automatic revocation" of the registration (§ 1265(g)). Until proper notice arrives, the owners and directors on the current registration stay responsible.

Closing has a rule too: owners and directors notify CDPH within 30 calendar days after a lab stops all testing for 30 days at that location (§ 1265(j)). And a registration lasts one year (§ 1265(e)(1)), so unlike the two-year federal certificate, it renews annually.

California also covers labs outside the state. The chapter applies to labs "receiving biological specimens originating in California" (§ 1241(a)), so an out-of-state lab testing California specimens needs a California license or registration. See testing specimens from other states.

What does a typical California opening look like?

For a new urgent care clinic, the order that avoids rework is: settle the test menu from the kits you will stock, file the CMS-116 with LFS, pay the CMS coupon when it arrives by email, and file the state registration with the same owners, director, tests and kits. The two filings must match. A test added later goes on both, and a new medical director triggers the 30-day rule above.

Which of our services covers it?

We prepare both filings for your owners and director to review and sign: the CMS-116 and the CDPH registration, with the test, kit and equipment lists built from each kit's instructions. Any CDPH online account stays in your lab's name, and you pay CDPH and CMS directly. Our State Lab Registration is $299 per state on top of the $399 Certificate of Waiver Application, and Renewal and Compliance Tracking ($299 per year) watches the annual state renewal and the 30-day rules. The California requirements page keeps the details current.