A “Fireside” Chat with CDPH Dr. Steven Otto Chief Medical Consultant CDPH / L&C Email: steven.otto@cdph.ca.gov Phone: 916-552-8672 California Department of Public Health

Radiology Supervision A new final rule at 416.49(b)(2) has changed the requirements for the supervision of radiologic services. The individual basically will have the same responsibilities as existed for the supervising radiologist as to safety, badges, etc. Now will NOT have to actually be a radiologist, but one who is qualified to be responsible.

Radiology Supervision

2nd Round of Surveys Generally, we have noticed marked improvement over the initial round 3 years ago. The actual regulations have changed in multiple areas, particularly Infection Control and Anesthesia

2nd Round of Surveys Check the Appendix L of the State Operating Manual periodically (at least twice a year) to see any changes. This is available anytime free of charge on the CMS website. Surveyors are all similarly trained, but are individuals in their approaches.

2nd Round of Surveys Uniformity of the Survey Process includes: Common training and certification of surveyors The depth of findings is also partially dependent upon the training and level of the surveyor i.e. a physician vs. HFEN i.e. an infection control consultant vs. HFEN

2nd Round of Surveys

Disputing a Finding The actual dispute of any findings would be directly with CMS after they have received and accepted the survey results collected by CDPH, who is the official “agent” of CMS in California. Informal discussion can occur between the survey Team and the facility, usually during the exit conference

Disputing a Finding The 2567 is NOT the forum for disputing a finding, but rather to put forward the facility’s Plan of Correction for deficiencies which were cited. A critical point: You will always be held to “do what you said you were going to do” – what is in your policies and procedures must be followed, and they must reflect the appropriate standards

Waivers A waiver is basically permission to provide an alternative approach to a proscribed regulation Waivers may ONLY be granted directly by CMS, as CDPH has no authority to grant any waiver of Federal reguations. Application would be directly to CMS

Infection Control CMS considers the following as accepted national guidelines: AORN APIC CDC SHEA AAMI

Infection Control Q-0241, §416.51(a) Standard: Sanitary Environment The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

Infection Control The following are more specialty-related guidelines which may be applicable: AAMI (reprocessing) WHO (mimics CDC generally) You may specify different guidelines for different areas – just make sure you have documented those choices and adjusted your policies and procedures accordingly

Infection Control Failure to adopt or identify a nationally recognized guideline will lead directly to a Conditions of Participation deficiency

Infection Control

Anesthesia §416.42(a) - Standard: Anesthetic Risk and Evaluation (2): Before discharge from the ASC, each patient must be evaluated by a physician or by an anesthetist as defined at §410.69(b) of this chapter, in accordance with applicable State health and safety laws, standards of practice, and ASC policy, for proper anesthesia recovery.

Anesthesia The regulations (as well as ASA standards) would require either a physician or anesthesia provider to physically remain in the facility until the patient is physically discharged (left) from the facility

Anesthesia

Cross-Reporting Between Agencies CDPH does report significant findings in an ASC (i.e. Immediate Jeopardy) directly to the Medical Board of California, which is the actual licensor of an ASC. CDPH does report sub-standard or criminal behavior on the part of a provider directly to the Medical Board of California

Cross-Reporting CDPH may also report the actions of a RN to the BRNA if warranted

Cross-Reporting

Hospital Privileges A question was asked regarding if an anesthesiologist on staff at an ASC had to have admitting privileges at a local hospital if a transfer agreement was not in place. If that physician is ONLY providing anesthesia services and has not surgical privileges, such as pain management, privileges would not be required

Anesthesia Limitations A question was asked regarding if there were limitations on which patients could receive services at an ASC based on medical conditions? Every ASC is charged with formulating their own P&P regarding which patients and conditions may receive services. The surveyor guidelines suggest some national standards guideline basis be established.

Anesthesia Limitations The most commonly used basis are the ASA Cardiac status guidelines. Most facilities will allow scheduling of patients up through an ASA Category III condition on a fairly routine basis. The evaluation and decisions are documented primarily in the Pre-Anesthesia evaluation, which must be signed by a Physician, and must be individualized and unique to each patient.

California Department of Public Health Thank you for your attention and participation