Download PHAM Contributors Meeting - the California Ambulatory Surgery

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
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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