1. GI Labs Steven Otto, MD EJD Chief Medical Consultant CDPH / Licensing & Certification

2. Survey Considerations Required personnel in suite Required personnel in suite Conscious Sedation Conscious Sedation Personnel Personnel Training Training Agents Agents PACU PACU

3. Recovery Room Recovery area must be staffed by qualified and training nursing personnelRecovery area must be staffed by qualified and training nursing personnel ACLSACLS PALS (if indicated)PALS (if indicated)

4. Personnel in Suite An R.N. is required to be present or immediately available as the Circulating NurseAn R.N. is required to be present or immediately available as the Circulating Nurse Physician may use RN, LPN, Surgical Tech to assist (optional)Physician may use RN, LPN, Surgical Tech to assist (optional) Another R.N. would be required if any level of Conscious Sedation is givenAnother R.N. would be required if any level of Conscious Sedation is given

5. Personnel The physician may use a tech or trained MA to assist in the procedure itselfThe physician may use a tech or trained MA to assist in the procedure itself Passing instrumentsPassing instruments Helping manipulate biopsy instrumentsHelping manipulate biopsy instruments May NOT act as circulating nurseMay NOT act as circulating nurse

6. Personnel If RN is acting to administer sedation agents, may NOT leave the head of the patient for any purpose during procedureIf RN is acting to administer sedation agents, may NOT leave the head of the patient for any purpose during procedure May NOT assist in operating biopsy toolsMay NOT assist in operating biopsy tools May NOT circulate within the roomMay NOT circulate within the room

7. Conscious Sedation A R.N. with specialized training may be allowed to administer mild-moderately sedation agentsA R.N. with specialized training may be allowed to administer mild-moderately sedation agents Training provided / approved by the facilityTraining provided / approved by the facility This would require full-time attention to patient at head of table.This would require full-time attention to patient at head of table.

8. Conscious Sedation Agents are administered by the trained R.N. per direct physician ordersAgents are administered by the trained R.N. per direct physician orders Including agentIncluding agent Dosage to be administeredDosage to be administered Physician’s presence in actual suite must be continuousPhysician’s presence in actual suite must be continuous

9. Conscious Sedation RN must be able to safely monitor the level of sedation in the patientRN must be able to safely monitor the level of sedation in the patient RN must be able to maintain a safe airway for the patientRN must be able to maintain a safe airway for the patient

10. Conscious Sedation Levels of SedationLevels of Sedation Mild: minimal sedation, patient conscious and can quickly respond to requestsMild: minimal sedation, patient conscious and can quickly respond to requests Moderate: patient may be resting but can be easily aroused to respond to a requestModerate: patient may be resting but can be easily aroused to respond to a request Deep: patient has lost part or all of protective airway reflexes, not immediately arouseableDeep: patient has lost part or all of protective airway reflexes, not immediately arouseable

11. Conscious Sedation CMS regulations allow the use of Mild or Moderate Sedation Agents to be administered by a trained RN under the physician’s direct supervisionCMS regulations allow the use of Mild or Moderate Sedation Agents to be administered by a trained RN under the physician’s direct supervision Deep sedation agents must only be administered by a licensed provider who has the privileges for anesthesia administrationDeep sedation agents must only be administered by a licensed provider who has the privileges for anesthesia administration

12. Conscious Sedation Deep Sedation Agents (per CMS)Deep Sedation Agents (per CMS) Diprovan (proprofol)Diprovan (proprofol) KetamineKetamine General anesthetic agentsGeneral anesthetic agents

13. Conscious Sedation FentanylFentanyl Great caution must be used with this agentGreat caution must be used with this agent Capable of quickly causing deep sedationCapable of quickly causing deep sedation Associated with “Stiff Chest Syndrome”Associated with “Stiff Chest Syndrome”

14. Contact Info My contact info: Dr. Steven Otto 1615 Capitol Drive, MS 3401 Sacramento, CA 95814 Phone: (916) 552-8672 Email: steven.otto@cdph.ca.gov