BILL ANALYSIS Ó AB 186 Page 1 Date of Hearing: March 22, 2011 ASSEMBLY COMMITTEE ON HEALTH William W. Monning, Chair AB 186 (Williams) - As Introduced: January 25, 2011 SUBJECT : Reportable diseases and conditions. SUMMARY : Permits the California Department of Public Health (DPH) to modify the list of communicable diseases and conditions for which clinical labs must submit specimens to the local public health laboratory to undergo further testing and allows DPH to modify the list at any time in consultation with the California Conference of Local Health Officers (CCLHO) and the California Association of Public Health Laboratory Directors (CAPHLD). Specifically, this bill : 1)Makes legislative findings and declarations regarding the need to enable prompt identification of an outbreak, send positive specimens to the public health laboratory for identification, and enable DPH to include newly emerging diseases and conditions in a timely manner. 2)Requires DPH to establish a list of communicable diseases and conditions for which clinical laboratories shall submit a culture or a specimen to the local public health laboratory to undergo further study. 3)Permits DPH to modify the list at any time, after consultation with the CCLHO and the CAPHLD, without being subject to California's Administrative Procedures Act (APA), which governs the adoption of regulations, but requires that DPH file the revised list with the Secretary of State for publication in the California Code of Regulations (CCR). 4)Exempts clinical labs that fail to submit cultures or specimens for mandatory diseases from civil and criminal penalties, unless the requirement has been noticed by DPH for at least six months in the CCR. 5)Deletes specific diseases that are enumerated in law as mandatory reportable diseases, thereby allowing DPH to reconstitute the list in consultation with CCLHO. EXISTING LAW : AB 186 Page 2 1)Requires DPH to establish a list of diseases and conditions which health care providers and local health officers are required to report to the local public health department. Allows DPH to modify this list and exempts this modification from requirements, governing changes in administrative regulations under APA. 2)Under regulation, requires labs to report test results on certain diseases considered to be of "public health importance." 3)Does not exempt DPH from complying with APA requirements when modifying the list of reportable diseases and conditions for which public health labs are required to submit specimens. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, technology is not currently available in California public health laboratories for different sub-typing techniques, such as DNA fingerprinting, that can be used to identify clusters of various organisms that cause illness. The author states that use of this specialized testing can help identify outbreaks and sources of outbreaks so they can be mitigated, and for this to be an effective public health tool, the public health laboratory needs to obtain the necessary specimens from all sources in order to be able to quickly identify the organisms causing illnesses and compare the subtypes, thus allowing a timely public health response. The author contends that by allowing DPH to quickly add conditions to the list of diseases for which clinical laboratories must submit specimens, this bill may save lives during an emergency. 2)BACKGROUND . Health care providers who know of a case, or suspected case, of any disease or condition on the DPH list are required to report to the local health officer of the jurisdiction where the patient resides and are required to send specimens to a clinical laboratory. Clinical laboratories include all hospital laboratories and community laboratories that receive tests from health care providers for analysis. Clinical laboratories are also required by AB 186 Page 3 regulation to report positive specimens to the local public health department. Currently laboratories are required to report communicable diseases, pathogens, and viral infections. Clinical laboratories are required to submit specimens for those listed diseases and conditions, while specimens for non-listed diseases and conditions are submitted on a voluntary basis. If there is a known or suspected outbreak of a particular disease or condition that is listed, the local health officer must report to DPH within a specified time period, and take the necessary steps to prevent further contamination or infection. The list of communicable diseases and conditions for which laboratories must submit cultures is established by regulation and adding or deleting a disease or condition requires an administrative regulation change under APA. The APA was intended to ensure transparency and full public participation when agencies change their regulations. The APA does permit adoption of emergency regulations, but requires a five-day public notice, and emergency regulations can only remain in effect for up to 180 days. According to the sponsor, it could take one and one-half to two years for DPH to update the list of reportable diseases, whereas under this, it could take as little as two months. 3)SUPPORT . The Health Officers Association of California (HOAC), the sponsors of this bill, write that public health laboratories are the front line in the war against disease outbreaks. These labs can quickly identify sub-types of contaminants such as E coli so that a common source outbreak can be identified and investigated. HOAC further states that public health laboratories can also examine avian flu isolates for strain typing to determine their potential to result in a human pandemic. HOAC contends that this bill will enable public health laboratories to better protect all Californians during the outbreak of a dangerous disease. 4)PREVIOUS LEGISLATION . a. AB 2786 (Committee on Health) of 2010 contained identical provisions to this bill. AB 2786 was vetoed by Governor Schwarzenegger, who stated in part: "The Department of Public Health, in a public health emergency, already has broad authority to request and receive laboratory data. I am also concerned that the Department, AB 186 Page 4 without such a public health emergency, could enact changes that affect both private and public laboratories without any regulatory oversight." b. SB 356 (Negrete McLeod) of 2007 is nearly identical to this bill. SB 356 was vetoed by Governor Schwarzenegger because the delay in passing 2008-2009 State Budget forced him to prioritize the bills sent to his desk. According to the Governor, SB 356 did not meet his standard as priority legislation. c. AB 1091 (Negrete McLeod), Chapter 262, Statutes of 2003 allows DPH, in consultation with the California Conference of Local Health Officers, to modify the list of reportable diseases that health care providers are required to report. DPH can modify this list at any time without having to comply with APA requirements. REGISTERED SUPPORT / OPPOSITION : Support Health Officers Association of California (sponsor) Opposition None on file. Analysis Prepared by : Melanie Moreno / HEALTH / (916) 319-2097