Dr. Steven Otto, Chief Medical Consultant Licensing and Certification Program

California Department of Public Health Licensing and Certification Program

CMS-directed Surveys

CMS Mandate for Survey

• In 2010, CMS the State to survey all of the existing certified ASC facilities • The goal is to survey each facility every 3 years for compliance with Federal regulations • Survey facilities are chosen by CMS and/or the State, and findings are all reported to CMS

CMS Criteria for Survey

• The Federal surveys in the ASC are based upon Title 42 of the Code of Federal Regulations (42 CFR) • The State Operating Manual (SOM) provides guidance for these surveys, and is found in Appendix L of the SOM

Areas Reviewed in Survey

• Patient Rights • Governing Body and Management • Surgical Services • Nursing Services • Infection Control • Patient Assessment and Discharge • Pharmacy Services

Areas Reviewed in Survey

• Quality Assurance Performance Improvement (QAPI) • Lab and Radiology • Environment • Medical Records

KEY POINT

• •

No matter what title is on the door of an ASC…..

It is first and foremost considered an ASC for survey purposes

CMS definition of ASC

• Located at 42 CFR 416.2

• An ASC is: – A distinct entity – Operates exclusively to provide surgical services to patients whose expected care is less than 24 hours – Has an ASC supplier agreement – Complies with all ASC Conditions for Coverages (CfCs)

Governing Body & Management

• 42 CFR 416.41: ASC must have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the ASC’s total operation.

– Must maintain oversight and accountability for QAPI program – Must have developed and maintained a disaster preparedness plan – Must ensure care in a safe environment

Surgical Services

• 42 CFR 416.42: ASC surgical services must be performed: – In a safe manner – By physicians who are qualified and granted clinical privileges – In manner consistent with generally accepted national standards of clinical practice – In a manner consistent with applicable State and local laws

Surgical Services

• 42 CFR 416.42(a) and (b) address the Anesthesia Services, providing for pre-op risk assessment and evaluation and the actual administration of analgesia/anesthesia.

• Analgesia: use of medication to provide relief of pain at the receptor level without altering the level of consciousness

Surgical Services

• Anesthesia types include: – General anesthesia, where patient is generally unconscious and whose life functions are supported/monitored by a trained anesthesia provider – Regional anesthesia, including epidural, spinal, and regional blocks such as a Bier Block

Surgical Services

• Anesthesia types also include Monitored Anesthesia Care (MAC) where sedation medications are administered and monitored by a trained anesthesia provider – Includes any Deep Sedation procedure Local anesthetics are the remaining class

Sedation Considerations

• CMS has defined 3 levels of sedation for a procedure – Minimal: consciousness is not affected, patient is generally awake and alert – Moderate: consciousness is not affected, though patient may require mild tactile or vocal stimulation to arouse – Deep: consciousness level is affected, patient may only respond to painful tactile stimulation

Sedation Considerations

• Sedation is a “continuum” and the potential for the patient slipping into the next higher level of sedation must always be addressed • CONSCIOUS SEDATION: this term actually includes both mild and moderate levels of sedation – Specifically excludes Deep Sedation, which will be discussed later in presentation

General Consideration Surgery

• Safe practices to include: – Sound infection control practices – Proper use of all equipment – Proper handling of any specimens – Implantable devices inspected and documented in record – Accounting for all instruments and materials – Avoidance of surgical fires

Patient Assessment & Discharge

• An ASC is expected to assess patients – Before surgery to assure it is reasonably safe for the patient to undergo the procedure – After surgery to assure the patient is ready for discharge or in need of additional care/transfer – The ASC retains the overall responsibility for these items, and cannot shift it all to the physicians

Patient Assessment & Discharge

• Anesthesia pre-assessments – If general anesthetic or MAC is to be used, must be performed by a

PHYSICIAN or CRNA

– The anesthesia services may be performed by a CNRA without supervision, as California is an opt-out state for this requirement. This does not extend to the pre-anesthesia requirement, however.

Patient Assessment & Discharge

• Each patient must have to be discharged: – A discharge order – Written discharge instructions – Overnight supplies – Follow-up physician appointment if applicable – Adult accompaniment unless exempted

Nursing Services

Nursing Services

• Under 42 CFR 416.46, the nursing services of the ASC must be directed and staffed to assure that the nursing needs of all patients are met.

– Must be under the direction of a designated RN – Must be sufficient in number and with appropriate qualifications

Infection Control

Infection Control

• Under 42 CFR 416.51, the ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.

Infection Control

416.51(a)

• The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

416.51(b)

• The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The ASC must demonstrate it is following acceptable national IC guidelines.

Infection Control

• The IC program must be under the direction of a designated and qualified professional who has training in infection control.

• IC must be an integral part of the facility’s QAPI program.

• Leadership must be on-site, but may be performed by a consultant

Infection Control

• Components of ongoing program include: – Development and implementation of IC activities related to all ASC personnel – Mitigation of the risk of healthcare-associated infections (HAI) – Identifying infections – Monitoring IC program compliance – QAPI– program evaluation and revision when indicated

Hand Hygiene

Hand Hygiene

• Cornerstone of infection control • Single-most effective method of preventing the spread of communicable disease • Can be performed with either soap and water or waterless hand gels (alcohol based)

Hand Hygiene

• Important to consider with use of gloves – Non-sterile gloves worn by personnel to help protect employee and prevent contamination by body fluids – Must wash hands after removing, even if donning a new pair of gloves

Conscious Sedation

Conscious Sedation

• CMS most recently updated the regulations concerning Conscious Sedation in the GACH regulations • The regulations in the Appendix L of the State Operating Manual are not as clear and concise regarding sedation policies

Conscious Sedation

• Understand that the new GACH directions on conscious sedation are primarily based upon the national guidelines set forth by the American Society of Anesthesiologists • GACH regulations do not hold legal authority in the ASC, but in this case can provide very helpful guidance in creating an effective policy on this topic

Conscious Sedation Definitions (ASA)

• Minimal Sedation: a drug-induced state during which patients respond normally to verbal commands. Ventilatory and cardiac functions are unaffected.

• Moderate Sedation: a drug-induced depression of consciousness during which patients respond “purposefully” to verbal commands, either alone or accompanied by light tactile stimulation.

Conscious Sedation Definitions

• Moderate (cont): No interventions are required to maintain a patient airway, and spontaneous respiration is adequate. This is also referred to as “Conscious Sedation” • Deep sedation: a drug-induced depression of consciousness during which patients cannot be easily aroused, but will respond “purposefully” following repeated or painful stimulation. The ability to independently

Conscious Sedation Definitions

• Deep (cont.): maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, as spontaneous ventilation may be inadequate. • General Anesthesia: a drug-induced loss of consciousness where patients are generally unarousable. Airway, ventilation, and cardiovascular support generally needed, including positive-pressure ventilation.

Conscious Sedation

• Currently, deviations from the standard care expected for a patient regarding conscious sedation will and are being written – Nursing Condition – Pharmacy Condition

Conscious Sedation Nursing

• 416.46(a): …Nursing services must be provided in accordance with recognized standards of practice – ASA does specifically outline the role of a “sedation nurse” – California Board of Registered Nursing has set out a scope of practice for the RN performing sedation. The Interpretive Guidelines specify here that services provided

Conscious Sedation Nursing

– are consistent with State laws governing nursing scope of practice, as well as nationally recognized standards The BRN determination delineates that a RN with special training and proof of competency may perform “conscious sedation” under the direct supervision of the physician. It also states that the Sedation Nurse may ONLY perform minimally interruptible tasks once a patient is stable and sedated.

Conscious Sedation Pharmacy

• 416.48: The ASC must provide drugs…in a safe and effective manner, in accordance with accepted professional practice • 416.48(a): Drugs must be prepared and administered according to established practices and acceptable standards of practice

Conscious Sedation Pharmacy

• The most applicable guidelines again for what drugs and how they are administered can be found in the ASA guidelines • Propofol and Ketamine – Defined by CMS in the GACH regulations as DEEP sedation agents only – Each has a black box warning which limits administration to a licensed anesthesia provider

Conscious Sedation State of the Practice

• Sedation Nurse may be used – RN with special training, ACLS, competency – Under direct supervision of physician – Able to recognize and rescue from Deep Sed.

– May do “minimal interruptible” tasks which do not require leaving patient’s side or continuously monitoring the patient – May not circulate or otherwise assist MD

Conscious Sedation State of the Practice

• Deep Sedation – Must be by a physician (or CRNA) with specialized training and privileged by the GB – May not utilize a RN for administering drugs, unless CRNA – May not perform procedure and serve as the sedation provider during same case – Must be trained and competent to rescue from a general anesthesia

Infection Control

• The standards for Infection Control have been strengthened and emphasized in CMS surveys in the ASC.

• 42 CFR 416.51:

The ASC must maintain an infection control program that seeks to minimalize infections and communicable diseases.

Infection Control

• CMS has instituted a standardized worksheet for surveying this condition which is very long and very detailed.

• IC is one of the most frequently-written deficiencies found in ASCs.

Infection Control Hotspots

• Endoscopy: cleaning and decontamination of the endoscopes • Sterility: assurance of sterilization for all surgical instruments for a procedure • Cleaning: assuring that instruments such as glucometers, hemoglobin testing meters are properly cleansed and sanitized between patients

Infection Control Hotspots

• Cross-contamination in the ASC – Hand washing protocols – Use of surgical scrubs properly in any operating area – Traffic patterns within the ASC – Separation of clean and dirty utility areas and instruments

California Department of Public Health Licensing and Certification Program

California Department of Public Health Licensing and Certification Program