SB 482 — Biological data analysis services: regulation.
Last action — Returned to Secretary of Senate pursuant to Joint Rule 56.
-
✓Introduced
-
2In Committee
-
3Passed Senate
-
4Passed Assembly
-
5To Executive
-
6Enacted
This bill died with 2009-2010 Regular Session. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
Summary
Existing law provides for the licensure and regulation of clinical laboratories and clinical laboratory personnel by the State Department of Public Health and makes a violation of these provisions a misdemeanor. Under existing law, only designated health care personnel are authorized to perform, under specified conditions, clinical laboratory tests or examinations that are classified as waived, moderate complexity, or high complexity under federal law. This bill would require an entity that provides post-CLIA bioinformatics services, as defined, to contract with a licensed clinical laboratory to process biological specimen collection kits, except as specified. The bill would require an entity that provides post-CLIA bioinformatics services to employ a specified expert for approval of the algorithms used in the interpretation of the biological data of a customer. The bill would further impose on an entity that provides post-CLIA bioinformatics services specified privacy, recordkeeping, disclosure, and audit requirements, and would impose specified duties on the State Department of Public Health in that regard. The bill would also subject those entities to specified provisions of existing law prohibiting unearned rebates, refunds, and discounts, a violation of which constitutes a crime. Because the bill would expand the scope of a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.
Bill Text
- Amended 04/14/09 - Amended Senate Current pdf April 14, 2009
- Introduced 02/26/09 - Introduced pdf February 26, 2009
- SB482 View text html
Action History
-
Returned to Secretary of Senate pursuant to Joint Rule 56.
-
Re-referred to Com. on JUD.
-
From committee: Do pass, but first be re-referred to Com. on RLS. (Ayes 7. Noes 1. Page 675.) Re-referred to Com. on RLS.
-
Set for hearing April 27.
-
Re-referred to Coms. on B., P. & E.D. and RLS.
-
From committee with author's amendments. Read second time. Amended. Re-referred to Com. on RLS.
-
To Com. on RLS.
-
From print. May be acted upon on or after March 28.
-
Introduced. Read first time. To Com. on RLS. for assignment. To print.
Sponsors
- Stephen C. Padilla · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 0 co-sponsors · 121 not signed on
Sponsors (1)
- Padilla, Stephen C. Democratic
Co-sponsors (0)
None.
Not signed on (121)
121 members have not signed on to this bill.
Show all 121 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Votes
| Party | Yea | Nay | Present | Not Voting |
|---|---|---|---|---|
| Unaffiliated | 8 | 1 | 0 | 2 |
| Total | 8 | 1 | 0 | 2 |
| % of votes cast | 73% | 9% | 0% | 18% |
How each member voted (11)
| Member | Party | Vote |
|---|---|---|
| Yee | — | Yea |
| Negrete | — | Yea |
| Oropeza | — | Yea |
| Romero | — | Yea |
| Aanestad | — | Nay |
| McLeod | — | Yea |
| Walters | — | Not Voting |
| Wyland | — | Yea |
| Corbett | — | Not Voting |
| Correa | — | Yea |
| Florez | — | Yea |
Subjects
Frequently asked questions
- What does SB 482 do?
- Existing law provides for the licensure and regulation of clinical laboratories and clinical laboratory personnel by the State Department of Public Health and makes a violation of these provisions a misdemeanor. Under existing law, only designated health care personnel are authorized to perform, under specified conditions, clinical laboratory tests or examinations that are classified as waived, moderate complexity, or high complexity under federal law. This bill would require an entity that provides post-CLIA bioinformatics services, as defined, to contract with a licensed clinical laboratory to process biological specimen collection kits, except as specified. The bill would require an entity that provides post-CLIA bioinformatics services to employ a specified expert for approval of the algorithms used in the interpretation of the biological data of a customer. The bill would further impose on an entity that provides post-CLIA bioinformatics services specified privacy, recordkeeping, disclosure, and audit requirements, and would impose specified duties on the State Department of Public Health in that regard. The bill would also subject those entities to specified provisions of existing law prohibiting unearned rebates, refunds, and discounts, a violation of which constitutes a crime. Because the bill would expand the scope of a crime, the bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason.
- Who sponsors SB 482?
- SB 482 is sponsored by Padilla, Stephen C. (Democratic).
- What is the current status of SB 482?
- This bill died with 2009-2010 Regular Session. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track SB 482?
- Track SB 482 free on One Click Politics — get push/email alerts when it moves.
Make your voice heard on SB 482
Find the representatives who decide this bill and tell them where you stand — for yourself, or mobilize your whole list in one click with One Click Politics advocacy software.
Stay ahead of SB 482
Last checked for changes 3 months ago · updated continuously
One Click Politics tracks every bill in Congress and all 50 states.
Track this bill →