Transcript Slide 1
Complying with Medicare’s
Conditions for Coverage:
Preparing for a Survey
Minnesota ASC Association
2011
Dawn Q. McLane RN, MSA, CASC, CNOR
RVP, Health Inventures
Are You Becoming a
Boiled Frog?
2DQMK
Overview of Changes
Conditions for Coverage (CfC) = the requirements that ASCs
have to meet to participate in Medicare (CFR sec. 416)
Must meet requirements for all patients not just Medicare
patients
Effective date: May 18, 2009
Currently 10 Conditions with 16 Standards
New: 13 Conditions with 35 Standards
Interpretive guidelines
http://ascassociation.org/guidelines.pdf - CfC interpretive
guidelines – December 2009
Summary of Changes
Conditions
Standard
Change?
State Law
No Change
Governing Body and Management
Contract Services
Hospitalization
Disaster Preparedness Plan
Revised
Surgical Services
Anesthetic Risk and Evaluation
Administration of Anesthetic
State Exemption
Revised
Quality Assessment and Improvement
Program Scope
Program Data
Program Activities
Performance Improvement Projects
Governing Body Requirements
Revised
Summary of Changes Continued…
Environment
Physical Environment
Safety from Fire
Emergency Equipment
Emergency Personnel
No Change
Medical Staff
Membership and Clinical
Reappraisals
Other practitioners
No Change
Nursing Services
Organization and Staff
No Change
Medical Records
Organization
Form and Content
No Change
Pharmaceutical Services
Administration of Drugs
No Change
Summary of Changes Continued…
Laboratory and Radiologic Services
Laboratory Services
Radiologic Services
Revised
Patient Rights
Notice of Rights
Advance Directives
Submission and Investigation of Grievences
Exercise of Rights and Respect for Property and Person
Privacy and Safety
Confidentially of Clinical Records
Change
Infection Control
Sanitary Environment
Infection Control Program
Change
Patient Admission, Assessment and Discharge
Admission and Pre-Surgical Assessment
Post- Surgical Discharge
Discharge
Change
Change in Definition of an ASC
a distinct entity that operates exclusively
for the purpose of providing surgical
services to patients not requiring
hospitalization
the expected duration of services would
not exceed 24 hours following admission
must have agreement with CMS and meet
the CfC
Governing Body and Management
responsible for policies governing
operations
Oversight and accountability for QAPI
program
Develops and maintains disaster
preparedness plan
ASC has transfer agreement with CMS
hospital or physicians performing surgery
have admitting privileges at hospital (that
meets CMS requirements)
Governing Body and Management
Disaster preparedness plan
written plan
provides for emergency care of patients,
staff and others in the facility in the event of
fire, natural disaster, functional failure of
equipment or other unexpected events that
would threaten the health and safety of those
in the ASC
coordinates the plan with state and local
authorities, as appropriate
conducts drills at least annually & completes
written evaluation of drill, promptly
implementing corrections
Quality Improvement
Develop, implement, and maintain
an ongoing, data-driven QAPI program
Standard - Scope:
demonstrates measurable improvement in patient
outcomes
improves patient safety – use of quality indicators,
performance measures or reduced medical errors
measure, analyze and track quality indicators, adverse
patient events, infection control and other aspects of
care
Standard - Data:
must incorporate data to:
monitor the effectiveness of services and quality of care
identify areas for improvement and changes in patient
care
Quality Improvement
Standard - Program Activities: Set priorities
for PI activities
focus on high risk, high volume, and problem-prone
areas
consider incidence, prevalence and severity of
problems
affect health outcomes, patient safety and quality of
care
track adverse patient events, examine cause,
implement improvement and ensure improvement
is sustained
implement preventative strategies targeting adverse
patient events and assure staff is familiar
Quality Improvement
Standard – PI projects
number and scope of projects reflects scope and
complexity of the organization
document projects being conducted – including (minimum)
reason for implementing the project and a description of
the project’s results
Standard – GB responsibilities – ensure that the
QAPI program:
defined, implemented, and maintained
addresses the ASC’s priorities and all improvements are
evaluated for effectiveness
clearly establishes expectations for safety
adequately allocated sufficient staff time, information
systems and training to implement the program
Patient Rights
ASC must inform the patient of patient’s
rights and must protect and promote the
exercise of such rights
Notice of rights
provide patient verbal and written notice
of patient’s rights
in advance of the date of the procedure
in a language and manner that the patient
understands
Patient Rights
Post the written notice of rights in place(s)
where it will be noticed by patients waiting for
treatment, including:
name, address, phone of State agency where patient
can report complaint
website for Office of the Medicare Beneficiary
Ombudsman
Disclose physician financial interests or
ownership in the ASC
in writing
In advance of the date of the procedure
Patient Rights
Advanced Directives
Provided the patient in advance of the date
of the procedure:
information concerning policies on advanced
directives
description of applicable state health and safety
laws
if requested, official state advanced directives
form
Inform patient of right to make informed
decisions regarding their care
Document in MR whether or not the patient
has executed an advanced directive
Patient Rights
Submission and investigation of
grievances
grievance policy documenting existence,
submission, investigation and disposition of a
patient’s written or verbal grievance to ASC
related to mistreatment, neglect, verbal,
mental sexual or physical abuse
document grievance
reported immediately to person in authority
if substantiated, reported to state and/or local
authority
specify timeframe for review and response
Patient Rights
investigate all grievances about care provided
document how grievance was addressed and
written notice of decision to patient including
o
o
o
o
name of contact person at ASC
steps taken to investigate
results of grievance process
date grievance process completed
Respect for property and person
no discrimination or reprisal
voice grievances regarding treatment
be fully informed about treatment / procedure
and expected outcomes prior to procedure
if incompetent, rights of patient exercised by
person appointed to act on behalf of patient
Patient Rights
Privacy and safety
receive care in a safe setting
free from all forms of abuse or harassment
Confidentiality of clinical records
comply with HIPAA related to privacy and security
of PHI and ePHI
Patient Rights Notification
Urgent Cases
May notify the patient on the day of
surgery only if the case is considered
urgent – must be documented by the
physician
the patient would be harmed (reduced likelihood of
good outcome if the procedure is not performed
same day or the patient would suffer increased
pain)
the ASC is an appropriate site of service for this
procedure
rights notification is performed prior to consenting
the patient
Infection Control
ASC maintains ongoing program to
prevent, control, and investigate
infections and communicable diseases:
include documentation that ASC is following
nationally recognized infection control
guidelines
Program is:
under direction of designated and qualified
professional with specialized training in infection
control
integral part of QAPI program
responsible for providing plan of action for
preventing, identifying and managing infections and
communicable diseases and immediately
implementing corrective and preventative measures
resulting in improvement
Pt admission, assessment and discharge
ASC ensures patient has appropriate
pre-surgical and post-surgical
assessments
all elements of discharge requirements
are met
Pre-surgical H&P
not more than 30 days before date of
surgery (may be performed same day)
comprehensive medical H&P completed by a
physician or other qualified practitioner
(state defined)
Pt admission, assessment and discharge
Upon admission
pre-surgical assessment completed by a physician or
other qualified practitioner
includes:
updated medical record entry documenting an exam for
any changes in the patient’s condition since the H&P
patient allergies to drugs and biologicals
placed in MR prior to surgical procedure
Post surgical assessment
condition must be assessed and documented in the
MR by a physician or other qualified practitioner or
RN with post –op experience
post surgical needs must be assessed and included in
the discharge notes
Pt admission, assessment and discharge
Discharge – ASC must:
provide patient with written discharge instructions
and overnight supplies
make FY appointment with physician when appropriate
either prior to procedure or before discharge,
provide
prescriptions
post-op instructions
Physician contact information for follow-up care
ensure patient has discharge order signed by the
physician who performed the procedure
ensure patients are discharged in the company of a
responsible adult, except patients exempted by the
attending physician
Hot Topics - Session Objectives
Review & Discuss Specific CMS
Regulations for the ASC
- Identify “Hot Buttons” YTD
- Assess Compliance Approach
w/Attendees
- Implementation Strategies
CMS “Hot Buttons” for 2011
ASC - 416.41(a) Contract Services:
“When services are provided through a
contract with an outside resource, the
ASC must assure that these services
are provided in a safe and effective
manner”.
Implementation Strategies:
Housekeeping:
- Review proposed cleaning schedule, products, supplies
& compare w/facility P&P; do OIG query.
- Contract should contain HIPAA language and/or have
on-site staff sign confidentiality/security
statements.
- Request immunization status for TB (suggest Hep.B)
- Evaluation process w/their supervisor should be
established.
- Direct observation, provide feedback.
- This service must be reviewed by GB on annual basis.
Implementation Strategies:
Lab/Pathology:
Obtain copy of license from physician lab Director,
perform verification; perform OIG query.
Obtain copy of malpractice insurance.
Obtain copy of the lab’s CLIA & CAP certification.
Ensure HIPAA language is included in contract.
Assess services performed (ie, timing of PAT
results, critical lab values, path reports).
This service must be reviewed by GB on annual basis.
Implementation Strategies:
Radiology: (also 482.26c)
Radiologist (MD/DO) must be credentialed effective
12/30/09 for at least consulting privileges.
Radiology techs must be credentialed as AHP
(AAAHC only), otherwise obtain copy of license, do
verification; OIG query; obtain malpractice
insurance.
Assess timeliness of follow-up radiology reports
when applicable.
Obtain input from Radiology Director for educational
purposes (ie., Radiation Safety, QC checks, etc.).
This service must be reviewed by GB on annual basis
CMS “Hot Buttons” for 2011
ASC - 416.52(a) Admission and Pre-surgical Assessment:
Each patient must be examined by a physician (or
other qualified practitioner in accordance w/state law)
on the DOS, prior to the start of the
surgery/procedure in order to assess changes in their
medical condition since the most recent H&P was done.
The physician may decide the extent of the update
assessment needed.
(This regulation should not be confused w/416.42(a)
which states that a physician must examine the
patient immediately before surgery to evaluate the
risk of anesthesia & of the procedure to be
performed).
CMS “Hot Buttons” for 2011
Same Day Procedures:
Patients may be admitted for
procedures the same day as the
procedure if:
the procedure is urgent and peforming
the procedure same day will
Result in an improved outcome
Waiting will cause the patient increased pain
and suffering
CMS “Hot Buttons” for 2011
The surgeon must document the
following:
reason for performing the procedure the
same day as notification of patient rights
(see previous slide)
the ASC is the appropriate site of
service
the patient received Patient Rights
Notification prior to consent for the
procedure
Implementation Strategies:
• If the physician finds no changes in the
patient’s condition since the most recent H&P
was performed, the following documentation in
the medical record is suggested per CMS IG:
• H&P reviewed, patient examined, no changes
noted in patient’s condition since H&P
performed. (check-box?)
• Likewise, any changes in patient condition must
be documented by the physician in the update
note prior to start of surgery/procedure.
• The H&P and this pre-surgical assessment
(DOS) must be placed in the medical record
before the surgery/procedure is performed.
CMS “Hot Buttons” for 2011
ASC - 416.42(a) Anesthetic Risk and Evaluation:
Before discharge from the ASC, each patient
must be evaluated by a physician (or by an
anesthetist in accordance with applicable State
health and safety laws*, standards of practice,
ASC policy) for proper anesthesia recovery.
*(ie, Opt-out states such as IA, KS, MN, NE)
Implementation Strategies:
Although the regulations do not specify the criteria that
must be used for this post-op evaluation, the IG suggest
that “recognized guidelines” be followed (ie, ASA as in the
article below).
Based on Practice Guidelines for Post-anesthetic Care,
Anesthesiology, Vol 96, No 3, March ‘02, the assessment
should include:
Respiratory function (RR, airway patency, O2 sat)
CV function (BP, P)
Temp
Pain
Nausea/Vomiting
Post-op Hydration
Mental Status
Other (depending on type of surgery/procedure)
Implementation Strategies: (continued)
Example Discharge Assessment (a check box could be used for applicable items or Y,
N, NA):
Alert / Oriented
Ambulating
Voided
Tolerated PO nourishment
Op site satisfactory
Peripheral circ. satisfactory
Reviewed instructions
Written instructions
Prescriptions
Pain Minimal <5 on Pain Scale (0-10)
Pt. assessed; medical condition and all vital signs (BP/P/R/O2sat/temperature) are
stable, may discharge per routine.
MD Signature:
Time:
In the above example, nursing staff could complete the 1st section, a physician must
complete the bottom section after reviewing the information in section 1.
Ultimately, the time documented above for the physician evaluation must reflect a
time prior to the patient’s actual discharge from the facility (HI Recommends eval
done within 45-1 hr prior to pt. D/C)
CMS “Hot Buttons” for 2011
ASC - 416.42(b) Administration of Anesthesia
Anesthetics must be administered only by:
- A qualified anesthesiologist.
- A physician qualified to administer
anesthesia, a CRNA or an AA.
- Unless state exempted for non-physicians,
the CRNA must be under the supervision of
the operating physician; AA’s must be under
the supervision of an anesthesiologist.
Implementation Strategies:
Local, topical anesthesia, IV moderate
sedation must be included on DOP form for
applicable physician in credentialing file.
CRNA’s should have a sponsoring/supervising
physician listed on DOP.
CRNA supervision must be listed on DOP
of corresponding physician or have a
separate DOP for this purpose.
Anesthesia contract/agreement and facility
P&P’s should address supervision of CRNA’s.
CMS “Hot Buttons” for 2011
ASC - 416.52(c)(2) Discharge:
The ASC must ensure that each patient has
a discharge order, signed by the physician
who performed the surgery or procedure.
ASC - 416.52(c)(3) Discharge:
The ASC must ensure all pts are D/C’d in
the company of a responsible adult, except
those pts exempted by the attending
physician (exemptions must be specific to
individual pts).
Implementation Strategies:
IG states, “no patient may be discharged from
the ASC unless the physician who performed the
surgery or procedure signs a discharge order”.
IG also says, “it is expected that a patient will
actually leave the facility within 15-30 minutes
after the discharge order is signed. (???)
Verify on pre-op phone call if pt will have a
responsible adult accompany them (get name and
number); provide rationale, facility policy. If noshow upon D/C, decisions will have to be made
for signing out AMA vs. calling cab, etc.
CMS “Hot Buttons” for 2011
ASC - 416.48(a) Administration of Drugs
Drugs must be prepared and administered
according to established policies and acceptable
standards of practice*.
*(In accordance w/state, federal laws and
nationally recognized expertise).
Implementation Strategies:
Any drawn syringes must be labeled with:
Time of draw, initials of person drawing,
medication name, strength, expiration date or
time.
Drawn syringes must be used on 1 patient and
discarded after the initial use.
Medications should not be prepared too far in
advance of their use (ie, do not draw up day
before or early morning for use throughout the
day)
This should only be administered by the person
who drew it up.
CMS “Hot Buttons” for 2011
ASC – 416.48(a) Administration of Drugs
Orders given orally for drugs and
biologicals must be followed by a written
order & signed by the prescribing
physician.
Implementation Strategies:
Must have P&P’s pertaining to a verification
process for verbal orders rec’d by a licensed
professional (ie, VORB).
ASC - The prescribing physician must sign, date
and time the written order in the patient’s
medical record as soon as possible after the
verbal order is issued (and in accordance
w/state law).
Take Aways….
• Ongoing, periodic re-assessment of educational
needs for employees and medical staff
regarding “CMS Hot Buttons”.
• Each CMS CfC is “pass or fail” from a
regulatory compliance perspective.
• Review your facility P&P Manuals; ensure that
corresponding documentation has been updated
to reflect CMS/AAAHC/TJC/state-specific
regs as applicable.
• All policies/procedures must be reflective of
active practice; assess if new process needed in
a certain area(s).
Thank You !
Questions?