Fireside Chat with MBC Kimberly Kirchmeyer Executive Director Medical Board of California

Evolution of the Outpatient Surgery Setting Program 1995 – Outpatient Surgery Setting Laws passed Any setting after July 1, 1996 that uses anesthesia at a level placing the patient at risk of losing their life-preserving reflexes has to meet Board accredited via four accreditation agencies – number of accredited - Unknown 2000 – required reporting of death or transfer of patient to hospital where stay lasts longer than 24 hours be reported to the Board 2007 – Capen v Shewry in 2007 requiring all settings that were any portion physician owned to be accredited, and not licensed by CDPH. Now the Board has 900 OSSs that are only accredited and total in database 1300, which include those also CMS certified.

Evolution of the Outpatient Surgery Setting Program 2011 in addition to newspaper articles regarding patient harm in these settings and continued discussion on the Board’s oversight of these facilities SB 100 passed and became effective January 2012 requiring significant changes in outpatient settings For MBC: Required a database that posted information on OSSs including accreditation status and action, owner information, accreditation agency information, effective and expiration date, etc. Evaluate AAs Evaluate complaints against an AA Maintain inspection information and make deficiencies, plans of correction, requirement for improvement, etc. public – which the MBC posts on the database Investigate all complaints

Evolution of the Outpatient Surgery Setting Program For OSSs: Post the plan of correction in public view and remove a certificate if revoked, surrendered, or denied Disclose full report of denial if applying to a different agency Require Adverse event reporting to CDPH (now to MBC) Submit a plan to the AA for procedures and protocols to be followed in the event of a serious complication Require all sites to be inspected – not a sample Comply with corrective action within timeframe from AA

Evolution of the Outpatient Surgery Setting Program For AAs: Conduct investigation of prior history of the OSS prior to accreditation Inspect OSSs at least every three years Upon receipt of complaint from MBC, inspect OSS within 5 days if poses an immediate risk; other complaints – report findings to board within 30 days Notify and update MBC on all OSSs that are accredited Notify Board within 24 hours when setting is reprimanded, suspended, revoked, or placed on probation or within 3 days if OSS is denied If OSS is revoked, notification letter sent to OSS saying can no longer perform procedures requiring accreditation

Evolution of the Outpatient Surgery Setting Program – Board’s Sunset Review – the OSS process and Board’s role was discussed and in some areas criticized. The Legislature, the public, and the Board believed a more active role by the Board was needed in the oversight of the OSSs.

OSS PROGRAM IMPROVEMENTS The Board established a two member Outpatient Surgery Setting Task Force. The task force in conjunction with staff have made some great improvements: Improved the Board’s database to where all information on the OSS is in the system where it can be viewed – caveat MBC requested all information from the AAs on the settings they have, whether certified or accredited and if CMS certified we placed a Yes in a data field so, those settings that are CMS certified only may not contain all information Improved the information for consumers on the website to make it more user-friendly Requested all complaint information come to the board first and then we will forward to the AAs for processing

OSS PROGRAM IMPROVEMENTS Determined that the Adverse Events need to be reported to the Medical Board and not CDPH. This language was included in the Board’s Sunset bill – SB 304 and became effective this January 1, 2014 This report is considered confidential by the Board The Board can issue a citation If a citation is issued for not sending a report, that will be public and posted to the OSS website profile

OSS PROGRAM IMPROVEMENTS Reviewed all laws and regulations pertaining to OSSs and AAs and recommended several other legislative changes Requiring the same reporting CDPH licensed facilities have to do for OSHPD under H&S code section 1216 for accredited agencies Requiring initial certifications of accreditation to be valid for only two years, instead of three Requiring inspections, after the initial inspection, to be unannounced Requiring peer review for all physicians in an OSS even if there is only one physician performing procedures in the OSS Lastly the task force also wanted to remove the section of law allowing an OSS to meet the requirements for accreditation by submitting a detailed procedural plan for handling medical emergencies

WHERE ARE WE NOW? Legislative proposals were submitted to the Senate Business and Professions Committee. The Board will seek an author in 2015 to carry the legislative proposals. The Board will be working to find a resolution to the third pathway for accreditation language with interested parties, too.

FUTURE ACTIONS The Board will continue to work on future legislative proposals The Board plans to conduct consumer outreach to notify the public they can check the accreditation status of their OSS The Board is developing an easier way to get data from the AAs and put it into the database, as it takes significant staff time The Board will work with the AAs to obtain information on which of the OSSs have both accreditation and CMS and which are only CMS The Board will continue to find ways to improve the oversight it has on the AAs and OSSs