Ambulatory Surgical Centers - Nevada State Health Division

Ambulatory Ambulatory Surgical Surgical
Centers Centers

Ambulatory Surgical Centers
•Overview
Outline Outline
• IInfection f ti CControl t l RRules l and d
Regulations
• Hepatitis C Outbreak in Nevada
• Recovery y
Act

Overview
• 59.47% increase in ASCs since 2002
• 43% of same- day surgery
• 15% of all ASCs with Condition Level
Noncompliance p during g
FY 2008

Updated Regulations
• New SOM in effect May y 18, , 2009
• Aspen tags and regulatory text revised and
renumbered
• Addition of CoP for Infection Control
• Infection Control Tool

ASC Guidelines for Infection Control
CFR 416.51 Condition of Participation: Infection Control
• “Th “The ASC must t maintain i t i an infection i f ti control t l program
that seeks to minimize infections and communicable
diseases.”
Standards (Q241-Q245)
• Sanitary Environment
• Ongoing IC program following IC guidelines
• Qualified professional directs IC program
• IC program an integral i t l part t of f QAPI
• IC program has a plan of action for combating infections
and communicable diseases

Survey Process
• Off-Site Survey Preparation
• Entrance Activities
• Information Gathering/ g Investigation g
• Preliminary Decision-Making and Analysis
of Findings
• Exit Conference
• Post- Survey y
Activities

Survey Procedures for Infection Control
CFR 461.51 Conditions for Coverage
IC Survey Procedures:
Infection Control Tool
• Developed by CDC, comprehensive tool to assist
surveyors in evaluating the IC practices of an ASC
(SOM Exhibit 351)
• One surveyor assigned to complete this tool during
survey, but all surveyors on the look out for
possible IC breaches
• Tool utilizes combination of direct observations
and interviews

Infection Control Tool

Interpretive Guidelines:
Infection Infection Control Program
Program
SOM Appendix pp L Tag g Q240 Q
• Maintenance of an Infection Control Program
– Functional and sanitary y environment
– Based on nationally recognized guidelines
– Directed by designated I.C. professional
– Integrated into QAPI program and ongoing
– Actions to prevent, identify and manage infections
– MMechanism h i for f immediate i di t implementation
i l t ti

Standard 416.51(a) (Q241): Sanitary Environment
Survey Su ey Procedures ocedu es
• Observe throughout the ASC the cleanliness of the
waiting areas, areas the recovery rooms rooms, the OR/procedure
rooms, floors, horizontal surfaces, patient equipment,
air inlets, mechanical rooms, supply, storage areas
• Interview staff to determine whether cleaning/
disinfection takes place appropriately. Ask for
supporting documents to confirm interviews
• Determine whether ASC has procedure for
decontamination after spills of blood or other bodily
fluid, whether used sharps are properly disposed, and
whether ASC re-uses single use devices. If so, are they
sent to an FDA-approved FDA approved vendor for reprocessing?

Standard 416.51(b) (Q242): Maintaining
ongoing ongoing IC IC program program Survey Survey Procedures
Procedures
• Determine whether ongoing program for
prevention, control and investigation of
infections and communicable disease among
patients and ASC personnel exists
• Determine whether policies and procedures of
IC program are implemented correctly
• Review parameters of the program to
determine whether it is consistent with
nationally recognized IC guidelines. Is there
documentation that the ASC has developed p
procedures and policies based on these
guidelines?

Standard 416.51(b)(1) (Q243): IC Program under
Qualified Qualified Professional
Professional
Survey Procedures
• Determine whether a qualified individual has
been designated with the responsibility of
leading the IC program
• Review personnel p file of the IC individual to
determine whether he/she is qualified through
ongoing education, training, or certification to
oversee the h IC C program

Standard 416.51(b)(2) (Q244): IC
Program Program integral part of QAPI Program
Survey y Procedures
• Determine whether ASC’s QAPI program
includes measures/indicators and activities
related to IC on an ongoing basis
• Determine whether there is evidence that QAPI
IC activities result in specific actions designed
to improve IC within the ASC

Standard 416.51(b)(3) (Q245): IC Program
responsible for providing providing a plan of action
Survey Procedures
• Ask IC professional to describe an actual
example of how, as a result of the action
plan, IC issues were identified and
corrected. Ask for documentation to
support.
• Ask IC professional to review IC plan of
action with h you and d explain l how h it
addresses basic elements of an IC
program program.

What Surveyors are looking for:
SOM Appendix pp L (Q241-Q245)
(Q Q )
• Sanitary Environment
• Ongoing IC program
• IC Program following recognized IC guidelines
• Qualified IC trained professional as director
• Identification and reporting system to track
infections
• Staff receive IC training
• Correct IC practices

Preventing Preventing the the Spread Spread of of Infection Infection
in in in in ASCs ASCs ASCs ASCs
• Maintenance of Sanitary Environment
• Implementation of appropriate prophylaxis
• AAseptic ti techniques t h i
• Hand washing
• Safe injection practices
• Appropriate use of equipment
• Disinfectants, antiseptics, and germicides
• Education

Reuse Reuse Results Results in in
Condition Condition Condition Condition Level Level Level Level Noncompliance
Noncompliance
Noncompliance
Noncompliance
• Needles
• Syringes
• Medication vials (single ( g dose) )
• IV solution bags
• Medication administration tubing g and
connectors
• Reprocessed p single-use g devices without
approval by FDA or FDA- approved
reprocessor for reprocessing

ASC ASC Hepatitis Hepatitis C C Outbreak Outbreak
Nevada Nevada Nevada Nevada 2008 2008
2008 2008

When infection isn’t prevented…
Hepatitis epattsCOutb C Outbreak ea 2008 008
• January 2, 2008- 2 cases of Hepatitis C
discovered at 1 facility y during g complaint p
investigation by state surveyors
• CDC identified 4 additional cases
• January 17,2008- 17,2008 Facility corrected unsafe
injection practices but still noncompliant with
2 CoPs during Federal Survey by state
surveyors
• January 30, 2008- Sister facility received
State Licensure and Federal Survey by state
surveyors and found to be noncompliant with
3C 3 CoPs, P including i l di reuse issues i
• Source- Reuse of syringes and multi-use of
single-dose medication vials
• Both facilities closed due to termination of
business license

When infection isn’t prevented…
Hepatitis C Outbreak 2008
2008
• February y 15, , 2008- Third facility y received State
Licensure Survey and Federal Survey by State
Surveys and many IC problems identified
• Late February- CMS notified by Nevada Bureau
of Licensure and Certification of potential
outbreak tb k
• February 27, 2008- Southern Nevada Health
District and NBLC held joint press conference

When infection isn’t prevented…
Hepatitis C Outbreak 2008
2008
• March 5- April p 4, , 2008- All ASCs received
State Licensure Surveys
• March 6- May 12, 2008- 25 Federal Surveys
Conducted (In addition to 3 conducted
earlier by State)
• June 5, 2008- 77 additional cases of
Hepatitis C linked to first facility
• June 2008- Hepatitis C Registry created
• 53,000 patients possibly infected with
HHepatitis titi BB, CC, and d HIV

Response p by y State
All 51 of Nevada ASCs received
State State Licensure Licensure Surveys Surveys
• 28 of 51 surveyed by the state had deficiencies
100%
80%
60%
40%
20%
0%
1 2 3 4 5 6
X Axis Details
1. Steralization/ Disinfection Issues
2. Reusing Single Dose Vials For Multiple Patients
3. Biological Testing Issues
4. Noncompliance with Manufacturer's Recommendations
5. IC Deficiencies
6. No Deficiencies
Total # ASCs
Surveyed
ASCs with
Problems

Response p by y CMS
28 ASCs received federal surveys
• 64% Condition Level Noncompliance
• 93% Federal F d l citations it ti
• 60% Infection Control issues
• 14% Syringe and single dose vial reuse
• 18% Involuntary terminated

% of ASCs with Infection Control Issues
during Federal Federal Survey
% of o ASCs with w Infectioon
Control/
Reusee
Deficienccies
70
60
50
40
30
20
10
0
Single dose Vial and
Syringe Reuse
IC Deficiencies
# of ASCs % of ASCs
Single dose vial and Syringe Reuse 4 14
Some level of Infection Control Deficiencies 17 60

2008 Pilot Program g
• Maryland, Oklahoma, North Carolina
• Test of a new II.C. C survey instrument
and use of tracer methodology
• Findings

American Recovery and Reinvestment
Act Initiative
Initiative
“To To carry carry out out activities activities to to implement implement
healthcare-associated infections
reduction strategies”
• 10 million to expanding ASC oversight
• Implement new survey process
• Increase frequency of inspections

Recovery Act impact on survey
procedure procedure…
Additional Features:
• Infection Control Instrument
• Tracer Methodology gy
• Additional Surveyor
• Frequency q y of surveys y increase to 33% of
ASCs per year

Recovery Act Implementation
• 10 million dollars for State Agencies
• Full implementation of new survey process
by FY 2010

July y 2009
Recovery Act Schedule
• Selection of states for 2009 implementation
• Start implementation in 2009 volunteer states
August 30, 2009
• Submission of plan for FY 2010 funding
September 2009
• Notice to states of FY 2010 approval and
funding levels
October 2009
• In-person training- All states

Recovery Act
GOALS
• Expand State Survey Agency’s capability
for conducting ASC surveys
• Ensure ASCs follow appropriate IC
standards and practices
• Improve IC deficiencies

Implications of Recovery Act
GOALS
• Double # of ASCs surveyed y
• 1/3 of all non-accredited ASCs surveyed
• 50% increase in IC deficiencies identified
• 95% of identified Condition-level deficiencies
remedied within 14-180 days y of the Plan of
Correction

Thank you! y
Questions?
steven.chickering@cms.hhs.gov
415-744-3679
Website
http://www http://www.cms.hhs.gov/Survey
cms hhs gov/Survey
CertificationGenInfo/01_Overvi
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