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Indiana Federation of Ambulatory
Surgical Centers
September 27, 2013
To promote and provide essential public health
services
Indiana Ambulatory Surgery Centers
Indiana ASC Provider Count
CY 1990 - 2013
2013 Excludes 11 Pending Applications
160
140
120
100
80
60
40
20
0
1990
92
94
96
98
00
02
Total
04
06
08
10
12
Average Number of Deficiencies
Deficiencies per Certification Survey
2008 – 1.0
2009 – 7.1
2010 – 7.7
2011 – 7.1
2012 – 5.1
2013 – 4.8
Source: Indiana data from CMS PDQ
S&C 13-58.2000
2000 Edition National Fire Protection
Association (NFPA) 101® Life Safety
Code (LSC) Waivers
Categorical Waivers for:
Medical Gas Alarms
Opening Exit Enclosures
Emergency Generator & Standby Power
Doors
Suites
Extinguishing Requirements
Clear Waste & Patient Record Recycling
Containers
S&C 13-25 LAC & ASC
Relative Humidity (RH): Waiver of Life
Safety Code (LSC) Anesthetizing
Location Requirements; Discussion
of Ambulatory Surgical Center (ASC)
Operating Room Requirements
Categorical Waiver for:
Relative humidity:
Minimum: ≥ 20%
Maximum: ≤ 60%
Cannot affect ventilation system
performance.
REGULATIONS AND
COMPLIANCE
ASC Physician Requirement

Definition of Ambulatory Surgery Center:
IC 16-18-2-14(a)(2)
– Is operated under the supervision of at least
one (1) licensed physician or under the
supervision of the governing board of the
hospital if the center is affiliated with a
hospital
ASC Physician Requirement

410 IAC 15-2.5-4(b)(3)(r): Medical Staff
– A physician shall be available to the center
during the period any patient is present in the
center.
– The interpretive guidelines for surveyors
include verification that there is a physician
immediately available by phone, during the
period a patient is in the center, to respond to
patients requiring emergency care and then
available on the premises within an acceptable
period of time, if necessary, and in accordance
with medical staff policies.
ASC Anesthesiologist Requirement

410 IAC 15-2.1-2(c)(1((a): Medical Staff
– Requires that a physician with specialized
training or experience in the administration of
an anesthetic supervise the administration of
the anesthetic to a patient and remain present
in the facility during the surgical procedure,
except when only a local infiltration anesthetic
is administered.
Hospital Physician Requirement

410 IAC 15-1.4-1(d)(3): Governing Board
– (A) In hospitals with at least 100 acute care staffed
beds, provide a licensed physician on the premises at
all times who has the responsibility to respond to
patients requiring emergency care
– (B) In hospitals of less than 100 beds, a minimum of a
licensed physician who has the responsibility to
respond to patients requiring emergency care and who
is on call at all times and immediately available by
phone and then available on the premises with 30
minutes
Question
Our ASC was built in the late 1980s.
We would like to remove the hopper
that was originally installed. The
center is ophthalmology and we do
not use the hopper. Can we remove
it? Do we need to obtain a waiver for
this? Who do we contact?
Response
Contact Todd Hite, Health Care
Engineering Program:
[email protected]
317-233-7166 for assistance in
determining required components for
an ASC per the AIA guidelines and/or
the possibility for waiver, if the
component is required.
Question
Review the new Medicare rule
regarding advanced directives and
not having a blanket statement that
living wills are not honored.
Although our recent survey was not
a federal survey, the surveyors did
not know about this rule when we
asked their opinion on the rule.
Response
Surveyor opinion about the regulation
is irrelevant.
Staff have been provided the update.
Rule: no blanket statement.
Centers: consult with counsel.
Question
The local hospital completes the biomedical safety checks on
our equipment. The print out for each piece of equipment
documents a pass/fail grade. The last surveyor said this
was not acceptable because it did not include the ground
current leakage results on the form. The hospital has
criteria that if not met, the equipment is taken out of
circulation. This is the same report that has been given to
us for over 20 years and now this surveyor states it is not
sufficient. The director at the hospital even mentioned a
previous ISDH surveyor said their policy meet the standard.
Also the surveyor said a triennial electrical current leakage
report was required. What rule is this?
Response
Rule: 410 IAC 15-2.5-7(b)
Specifically: 15-2.5-7(b)(4)(B)(iii)
Waiver?
Was a citation given?
Question
The surveyor mentioned if the
generator battery is not enclosed, we
need to complete a yearly
hygrometer testing of the specific
acid in the battery. Where is this rule
located?
Response:
“Buried” in the LSC, Code 110,
Appendix as a ‘should’.
Maintenance free: not allowed.
Cited??
Question
Please let the membership know where
the 2008 rules with the guidance to
surveyors are located. Is there any
document that denotes the changes
from the 2000 edition compared to
the 2008 edition?
Response
http://www.in.gov/isdh/files/410_iac_15-2.pdf
No cross-walk from 2000 to 2008
Question
The surveyor reviewed the pest control
report and mentioned it should
include not only the product that was
used but also what bugs they were
looking for. What rule is this?
Response
No rule; but…..
Question
Part 2 Infection Control and Related Practices Page
10 Letter K "Multidose medications used for more
than one patient are not stored or accessed in the
immediate areas where direct patient contact
occurs"
1-Does this include enclosed and locked anesthesia
carts located in the OR's?
2-If so, what are acceptable storage and access
methods if multidose medications are used in
order to meet this regulation?
Response
Yes: 2. B.11 If multi‐dose vials are used for more than one patient,
they do not enter the immediate patient treatment area (e.g.,
operating room, patient room, anesthesia carts) . Note: if
multi‐dose vials are found in the patient care area they must be
dedicated for single patient use and discarded after use.
If using multi-dose vials, store them somewhere besides ORs, patient
rooms or anesthesia carts.
Question
Ask if an endoscopy center can get a
waiver for the scrub sink or at the
very least put it in the locker room.
Also want to know if you can call any
sink a scrub sink or does it
technically have to be a ‘scrub sink’?
Response
Scrub sinks are a defined type of sink.
Not any sink can be a ‘scrub’ sink.
No scrub sinks in locker rooms.
A waiver request may be submitted for
good cause shown.
(V) Chicago Active Providers = 669 Total Number of Surveys = 114
%
Providers
Tag #
Tag Description
# Citations Cited
Q0104 SAFETY FROM FIRE
54
8.10%
Q0100 ENVIRONMENT
44
6.60%
Q0241 SANITARY ENVIRONMENT
27
4.00%
Q0162 FORM AND CONTENT OF RECORD
26
3.90%
Q0242 INFECTION CONTROL PROGRAM
24
3.60%
Q0181 ADMINISTRATION OF DRUGS
22
3.30%
Q0221 NOTICE OF RIGHTS
19
2.80%
Q0224 ADVANCED DIRECTIVES
14
2.10%
Q0220 NOTICE - POSTING
12
1.80%
Q0262 PRE-SURGICAL ASSESSMENT
12
1.80%
Q0223 NOTICE - PHYSICIAN OWNERSHIP
10
1.50%
Q0061 ANESTHETIC RISK AND EVALUATION
9
1.30%
Q0043 DISASTER PREPAREDNESS PLAN
9
1.30%
Q0101 PHYSICIAL ENVIRONMENT
9
1.30%
Q0232 SAFETY
9
1.30%
Q0261 ADMISSION ASSESSMENT
8
1.20%
Q0202 RADIOLOGIC SERVICES
8
1.20%
Q0233 SAFETY - ABUSE/HARASSMENT
8
1.20%
Q0141 ORGANIZATION AND STAFFING
7
1.00%
%
Surveys
Cited
47.40%
38.60%
23.70%
22.80%
21.10%
19.30%
16.70%
12.30%
10.50%
10.50%
8.80%
7.90%
7.90%
7.90%
7.90%
7.00%
7.00%
7.00%
6.10%
Tag #
Q0242
Q0221
Q0224
Q0162
Q0223
Q0220
Q0241
Q0106
Q0232
Q0181
Q0202
Q0141
Q0083
Q0101
Q0233
Q0225
Q0182
Q0084
Q0226
Total
Indiana Number
Active
of
Providers Surveys =
= 122
25
%
Providers
Tag Description
# Citations Cited
INFECTION CONTROL PROGRAM
9
7.40%
NOTICE OF RIGHTS
9
7.40%
ADVANCED DIRECTIVES
7
5.70%
FORM AND CONTENT OF RECORD
7
5.70%
NOTICE - PHYSICIAN OWNERSHIP
7
5.70%
NOTICE - POSTING
7
5.70%
SANITARY ENVIRONMENT
6
4.90%
EMERGENCY PERSONNEL
5
4.10%
SAFETY
5
4.10%
ADMINISTRATION OF DRUGS
4
3.30%
RADIOLOGIC SERVICES
4
3.30%
ORGANIZATION AND STAFFING
3
2.50%
PERFORMANCE IMPROVEMENT PROJECTS
3
2.50%
PHYSICIAL ENVIRONMENT
3
2.50%
SAFETY - ABUSE/HARASSMENT
3
2.50%
SUBMISSION AND INVESTIGATION OF GRIEVANCES
3
2.50%
ADMINISTRATION - ADVERSE REACTIONS
2
1.60%
GOVERNING BODY RESPONSIBILITIES
2
1.60%
GRIEVANCES - MISTREATMENT, ABUSE
2
1.60%
%
Surveys
Cited
36.00%
36.00%
28.00%
28.00%
28.00%
28.00%
24.00%
20.00%
20.00%
16.00%
16.00%
12.00%
12.00%
12.00%
12.00%
12.00%
8.00%
8.00%
8.00%
Indiana State Department of Health Mission
To promote and provide essential
public health services