Transcript 34 - the California Ambulatory Surgery Association

Making the Case for Why…
“… It’s Quality, not Quantity”
Bruce B. Ettinger, MD, MPH
Certified Federal Medicare Surveyor (Ret)
Consultant for Regulatory & Accreditation Compliance
© 2013 B. Ettinger MD/MPH
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Proposals:
 Harm (risk of) in ASCs - a function of
• rapid growth and development of the ASC
industry
• related activities within individual ASCs.
 QAPI - the most critical Condition for Coverage
• operational effectiveness and efficiency
• safety and quality of care
© 2013 B. Ettinger MD/MPH
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Presentation Objectives

Understand and apply the Regulations to operations
and clinical practices, to create and maintain a “safe,
sanitary, and functional environment” of care.

Employ the regulations as guidelines and checklists
as a method of “quality control” for all clinical,
operational, and administrative services.

Incorporate the concepts of “systems' approach” and
“minimum necessary standard,” when developing
and implementing facility policies and procedures.
© 2013 B. Ettinger MD/MPH
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Session Overview
• Risk of harm in the ASC
• Regulatory Focus for Quality Assessment/
Performance Improvement
• Survey Experience
• (Selected Issues)
• Summary and Conclusions
© 2013 B. Ettinger MD/MPH
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PLEASE NOTE that the purpose of this discussion is to promote
awareness of heath care regulations as guidelines for safe
practices and quality of care in Ambulatory Surgery Centers.
The opinions, suggestions, and conclusions are those
of the presenter, as based on experience with surveys and the
regulations, but they are not intended to replace more specifically
directed consultations, including legal advice, to address the
needs of specific facilities, issues, or providers.
Nevertheless, inquiries are welcome, but thereafter we
recommend follow-up discussions with your ASC consultants and
appropriate health care attorneys to confirm compliance with
all applicable laws and regulations, and their application and
relationship to the federal Conditions for Coverage and related
Accreditation requirements.
© 2013 B. Ettinger MD/MPH
5
Request:
This work includes intellectual property
that is in copyrighted, and in preparation
for publication. Please do not distribute or
otherwise use at this time.
Thank you.
© 2013 B. Ettinger MD/MPH
6
But don’t despair…
MURPHY'S LESSER-KNOWN LAW
The things that come to those who wait,
will be the things that were left behind
by those who got there first !
© 2013 B. Ettinger MD/MPH
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“Listen carefully, I don’t have much time.”
Charles Barsotti, New Yorker Magazine, July 8 & 15, 2013, p 28
© 2013 B. Ettinger MD/MPH
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ISSUES
“Little is known about ASC quality…. The
immaturity“ of the ASC quality measurement
literature [and] the lack of controls for patient
risk factors, points to the need for more
research.”
RAND Health, 2009. California Ambulatory Surgery Centers:
A Comparative Statistical and Regulatory Description
“Far too many surgery centers tend to allow
shortcuts in surgeon's H&Ps, anesthesia
supervision, infection control, safety, peer review
and quality improvement.”
Herzog G. Outpatient Surgery Magazine Online, 11/5/12
© 2013 B. Ettinger MD/MPH
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Rapid Growth of the ASC Industry

Increasing number of ASCs - 67%, 1997 - 2004 (1)

Increasing volume of patients
•
•

3.3 million Medicare beneficiaries (2010) (2)
older; coexisting medical problems
Increasing number, type & complexity of procedures
•
•
•
•
•
~ 23 million surgeries annually (1)
advances in technology and skills
longer procedure time
longer and deeper levels of anesthesia
stacking multiple procedures at one time
(1)
(2)
© 2013 B. Ettinger MD/MPH
American Hospital Association, 2011
MEDPAC Report to Congress: Medicare Payment Policy, 2012
10
Number of Medicare-Certified ASCs
5260 in
2013
Amer Hosp Assoc
5175 in
2008
Rpt to Congress
2010: Medicare
ASC Value-Based
Purchasing Plan
1000 in
1988
1 in
1970
Source: MedPAC, Data Book, June 2006
in Ambulatory Surgery Centers: A Positive Trend in Health Care
http://www.leg.state.nv.us/74th/Interim_Agendas_Minutes_Exhibits/Exhibits/HealthCare/E042108L-2.pdf 4/21/08
© 2013 B. Ettinger MD/MPH
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FORECASTED DEMAND GROWTH IN THE
NUMBER OF ASC PROCEDURES BY SPECIALTY
Source: Etzioni DA, et al. Ann Surg. 2003 Aug;238(2):170-7, The aging population and its impact on the surgery workforce, in Ambulatory Surgery
Positive MD/MPH
Trend in Health Care (http://www.leg.state.nv.us/74th/Interim_Agendas_Minutes_Exhibits/Exhibits/HealthCare/E042108L-2.pdf 4/21/08)
©Centers:
2013 B.AEttinger
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Rapid Growth of ASC industry
 Volume + Complexities creates risk for Injury

Problems include (CMS)
•
•
•
•

inappropriate use of technology (overuse,
under-use, misuse)
inappropriate cost containment policies &
practices
short cuts - “Time is money”
“The cost of poor quality… doing things badly”
Need - increased Governing Body oversight
to keep pace with rapid increases in volume,
technology, internal facility growth, etc.
© 2013 B. Ettinger MD/MPH
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Why does harm occur?
 Uncertainty for the patient
• randomness of disease (occurrence; severity)
• relative lack of knowledge

Uncertainty for the physician
•
•
•
diagnosis – best educated guess
effect of interventions - failure to keep pace with
science and technology.
other
 Variation in processes and outcomes of care
 Unclear lines of accountability
•
© 2013 B. Ettinger MD/MPH
provider; facility
14
Why does harm occur?

Health Care
• variation, uncertainty, randomness - lead to
entropy

Entropy
• disorder or unpredictability
• uncertainty associated with a random variable
• entropy + lack of accountability = risk of harm
• “Left unattended, things can go wrong.”
© 2013 B. Ettinger MD/MPH
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Institute of Medicine
Medical Error
Active Errors

unsafe acts
• commission
• omission (lack of action)
committed by an individual
 immediate potential for
harm
 uncommon - sporadic unpredictable

“ To Err is Human,” National Academy Press, 2000;
© 2013 B. Ettinger, MD/MPH
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Institute of Medicine
Medical Error
Active Errors

unsafe acts
• commission
• omission (lack of action)
committed by an individual
 immediate potential for
harm
 uncommon - sporadic unpredictable

Latent Errors






system deficiencies
dormant – hidden within
system’s infrastructure
potential for harm
sequence of events - not a
single cause
activated by triggering event
not incompetence or
negligence
• “aligning the holes in Swiss
cheese”
Includes all support services and other operational and administrative services
“ To Err is Human,” National Academy Press, 2000
© 2013 B. Ettinger MD/MPH
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Clinical Concern
Active Error
X
OUCH !
Adverse Event
© 2013 B. Ettinger MD/MPH
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Clinical Concern
Triggering Event
X
(Layers of Defense)
Policies & Procedures
Credentialing; Competency
Infection Control
QAPI; etc.
Clinical
Providers
Lab, X-Ray,
Blood Bank, etc.
Management &
Administration
Facility
Infrastructure, etc.
Adapted from Reason J. Managing the
Risks of Organizational Accidents, 1997
© 2013 B. Ettinger MD/MPH
Latent (Systems)
Factors
OUCH !
Adverse Event
19
Institute of Medicine; Joint Commission
Preventable Medical Error, Adverse Event

unplanned, unanticipated, unexpected event
•
unrelated to the underlying condition

use of wrong plan, or failed or unexecuted plan

resulting in harm …

•
death, or serious physical or psychological harm
•
with or without permanent effect
… or the risk of harm
© 2013 B. Ettinger MD/MPH
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Incident Causation Model
Adapted from Patient Safety: Achieving a new standard
for care. National Academies Press, 2004, p228
NEAR MISS
Return to Normal
Technical
Failure
Human
Failure
YES
YES
Dangerous
Situation
Adequate
Defenses
Adequate
Recovery
NO
Organization
Failure
NO
Developing
incident
ADVERSE
EVENT
PROCESSES OF CARE
© 2013 B. Ettinger MD/MPH
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21
- Regulatory Focus Safer Practices, Patient Safety
and Quality of Care
“Safe, sanitary, and functional” environment of care”
© 2013 B. Ettinger MD/MPH
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Quality Defined
The Quality of Health Care in the United States:
Shuster MA, in Crossing the Quality Chasm, pp 231-249

“The degree to which health services…
increase the likelihood of desired health outcomes,
and are consistent with current professional
knowledge.”

“Providing patients with appropriate services,
in a technically competent manner, with good
communication, shared decision making, and
cultural sensitivity.”
© 2013 B. Ettinger MD/MPH
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The Why of QAPI and Regulations
Patient Safety: Achieving a new standard of care.
Institute of Medicine: National Academy Press, 2004
“Safety - freedom from accidental injury, …
a preeminent feature of health care quality.”
“Quality Chasm” - The gap between what health care
should be, and what it is - what people should receive,
and what they actually receive.
“If we cannot measure outcomes, we cannot begin to
manage them.”
Gee, R, et al. Obstet/Gynecol 2013:121;507
© 2013 B. Ettinger MD/MPH
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The “How” of QAPI and Regulations
“… fundamentally designed as guidelines to
preemptively protect patients.”
IOM 2004, Patient Safety: Achieving a New Standard of Care
Guidelines for structures and processes of care
•
•
•
•
what must be in place (not how to accomplish)
broad terms - each facility adapts the regulations
to its mission and community of service
bylaws, rules, regulations, policies and procedures
required facility documents - must be implemented
“Minimum necessary standards”
© 2013 B. Ettinger MD/MPH
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Critical Purpose of the Regulations

Reduce the occurrence of active/latent errors,
adverse events, and near misses (potential or
risk for AEs).

In QAPI terms - minimize the “SCOPE, SEVERITY,
and FREQUENCY” of errors, adverse events and
near misses.

Provide tools and directives in the Regulations,
Interpretive Guidelines, and Survey Procedures.
© 2013 B. Ettinger MD/MPH
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Regulatory Oversight and Compliance
NEAR MISS
Return to Normal
Technical
Failure
Human
Failure
YES
Dangerous
Situation
Adequate
Defenses
NO
Organization
Failure
Developing
incident
YES
Adequate
Recovery
NO
ADVERSE
EVENT
PROCESSES OF CARE
© 2013 B. Ettinger MD/MPH
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QAPI - The Linch-Pin for Quality in ASCs
 Specific Program/Plan is not required
•
but strongly recommended (ASC mission, vision, values)
 Program and Process musts (no choice)
•
•
•
comprehensive (facility-wide) – ongoing - systems
approach
identify opportunities to improve patient care
data-driven to demonstrate improvements
• use quality indicators &/or performance measures
• identify problems - implement remedial actions
•
monitor effectiveness – evaluate corrective actions
© 2013 B. Ettinger MD/MPH
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Summary of Quality Assessment/Performance
Improvement Regulations (Q 80 - 84)


Focus
•
high risk/volume, problem prone procedures (low volume)
•
adverse events, near miss (active/latent errors, w/o injury)
•
all other areas for latent factors (operational,
administrative, e.g., credentialing, RN staffing, etc.
•
Patient-centered – surveys
Measurable = ability to compare
•
•
•
•
benchmark - before/after
“track and trend”
incidence (prevalence, severity)
improvements = PDCA
© 2013 B. Ettinger MD/MPH
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Quality Indicators - Processes and Outcomes

Known, validated indicators
•

consistent with national professional societies,
and/or accepted standards of care
Internal indicators
•
•
high risk, high volume
problem-prone areas
•
•
•
•
New Technology
New Skills,
Co-Morbidities, etc.
adverse events & near misses
low volume procedures
infection control (refer to Q 240)
every other aspect of care and services in the ASC
© 2013 B. Ettinger MD/MPH
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•
Burn - % of ASC patients experiencing burn before discharge
•
Prophylactic intravenous antibiotic timing - % of ASC
patients receiving appropriate antibiotics , on time
•
Hospital transfer/admission - % of ASC patients transferred,
prior to formal discharge
•
Fall - % of ASC patients experiencing a fall
•
Wrong site, side, patient, procedure, implant,
[medication] - % of ASC admissions experiencing any “wrong”
© 2013 B. Ettinger MD/MPH
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IG Examples of Quality Indicators (Q82)
(based on National Quality Forum (NQF) standards for ASCs)
• Burn - % of ASC patients experiencing burn before discharge
Theseintravenous
are theantibiotic
same timing
as - % of ASC
• Prophylactic
patients receiving appropriate antibiotics , on time
•
current ASC Quality
Hospital transfer/admission - % of ASC patients transferred,
prior toReporting
formal discharge requirements!
• Fall - % of ASC patients experiencing a fall
• Wrong site, side, patient, procedure, implant,
[medication] - % of ASC admissions experiencing any “wrong”
© 2013 B. Ettinger MD/MPH
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QAPI - Quantitative, Data-Driven Methodology

Track and Analyze - incidence (prevalence, severity)

Benchmark and Gap Analysis/closure
•
•
•

identify desired goal (benchmark)
identify (root) causes for differences
close gap between current activity and goal
Demonstrate sustained improvements
• implement preventive strategies
• compare before/after implementing corrective actions

Sophisticated statistical methods not expected
• must have appropriately qualified personnel to collect and
interpret data
• on-line programs, consultant okay
© 2013 B. Ettinger MD/MPH
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Benchmarking (goal-setting)
 Purpose
•
•
comparison with accepted standards
uses specific indicators, and data (metrics) of performance
•
understand differences (gaps)
 Examples
•
•
•
Internal - patient surveys; staff focus groups; incidence
calculations
Best Practice standard - preliminary evidence of
effectiveness, w/wo expert opinion
Evidence-Based standard - best available evidence from
simple observations to bona fide systematic research
© 2013 B. Ettinger MD/MPH
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Incidence
Rate (frequency) at which a situation occurs
•
•
•
think… “I” stands for “Interval”
measured in intervals over time (day, month, year, etc.)
expressed as %
(# of problems or observations)
(total # of “at risk” situations over time)
I =
I =
(# Antibiotics given on time)
(Total number of cases at risk
for SSI, for a month, or year)
X 100 = %
I (ABx) = (800 ABx on time) / (1000 procedures per year)
= 8/10 x 100 = 80% w appropriate ABx per year
© 2013 B. Ettinger MD/MPH
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Benchmarking and Gap Analysis/Closure to
Improve Processes and Outcomes of Care

If Incidence of on-time Abx is 80%, and benchmark
(local, regional, or national average) is 97% *
•

Gap is 17% --- ASK: Why the difference ?
Implement program to reduce the gap
•
•
•
•
•
Investigative methods, e.g. root cause analyses (case)
Look for common causes, issues, events (“trend”- all
cases)
Implement corrective actions to close the GAP
Re-measure at defined intervals (“track”)
Repeat until gap is closed, or as close as possible after
repeated trials.
© 2013 B. Ettinger MD/MPH
* Medicare Hospital Compare, 7/18/13. 10 0 Patient Safety Benchmarks,
Becker's Hospital Review, 8/12/13. www.beckershospitalreview.com
36
CAUSES
EFFECT
Ishikawa Fishbone Diagram
© 2013 B. Ettinger MD/MPH
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Benchmarking - Key to Safer Practices
Similar to Mission, Vision and Value Statements
Organizational
Directives
Benchmarking
Mission
Who you are.
What you do.
Reveals gaps
(Where you are)
Vision
Where you want to go,
from where you are.
How you plan to get
there.
The goals for best practices
and outcomes.
(Actual benchmarks)
Value
Ethics, qualities, and
processes to fulfill
mission and vision.
Processes to close the gaps,
Gap Analysis, (RCA
FMEA, PDCA, etc.)
© 2013 B. Ettinger MD/MPH
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QAPI: Governing Body Responsibilities (Q 84*)

QAPI Program Defined
•
•
•

QAPI Projects
•
•
•

expectations for safety
ASC’s priorities - chooses indicators
implemented, maintained, evaluated for effectiveness
conducted on annual basis (not episodic)
reflects scope and complexity of ALL services & operations
specifies data collection methods, frequency, details
Allocates sufficient staff, time, information systems,
and training to implement the QAPI program
* Q84, with IGs & Survey Procedures, provides the outline for developing
QAPI Program, from which Projects are derived and implemented.
© 2013 B. Ettinger MD/MPH
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Survey Experience
© 2013 B. Ettinger MD/MPH
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ASC Survey Findings
LA County, June 2009 - December 2010

47 ASC surveys - 32 reports (68%) available for
review

399 total violations (Conditions, Standards)
•
•
•
average 8 - 9 per facility
range 0 to 26
2 facilities with 26 violations

2/3rds of facilities with 10 or more violations

225 of 399 violations (56.4%) were repetitive
•
i.e., identified across facilities
© 2013 B. Ettinger MD/MPH
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TABLE 1.
REGULATORY DOMAIN
(in order of publication in the Federal Regulations)
Total # Violations in 32 ASCs
Condition
(% *)
Standard
(% *)
1. General Conditions, and
2. Compliance with Laws
7
(6.40)
0
3. Governing Body, Management
23
(21.0)
4
Totals
(% *)
(0)
7 (1.6)
19
(6.6)
42 (10.5)
(3.7)
8
(2.8)
12 (3.0)
18
(16.5)
69
(23.8)
87 (21.8)
4
(3.7)
23
(7.9)
27
(6.8 )
20
(18.3)
43
(14.8)
63
(15.8)
8. Nursing Services
8
(7.3)
13
(4.5)
21
(5.3)
9. Medical Records
1
(1.0)
18
(6.2)
19
(4.8)
10. Pharmacy Services
13
(12.0)
17
(5.9)
30
(7.5)
11. Lab and Radiology
4
(3.7)
11
(3.8)
15
(3.8)
12. Patient Rights
1
(1.0)
16
(5.5)
17
(4.3)
13. Infection Control
5
(4.6)
27
(9.3)
32
(8.0)
14. Admit, Assess, Discharge
1
(1.0)
26
(9.0)
27
(6.8)
Totals * Rounded for presentation
109 (100.2)*
4. Surgical Services
5. QAPI
6. Environment of Care
7. Medical Staff
© 2013 B. Ettinger MD/MPH
290 (100.1)*
399 (100)
42
Frequency of Regulatory Violations (by Domain)
90
80
Number of
Violations
Condition
Standard
70
60
Combined
50
40
30
20
10
0
nd
Co
it io
&
ns
ws
La
v
Go
Bo
dy
rg
Su
ce
Sv
h
y
ff
ol
ts
PI
nt
ds
iol
ng
ac
isc
ntr
Sta
ec
igh
ad
me
QA
r si
m
D
o
/
n
u
R
R
R
r
d
C
s
o
a
N
d
nt
Me
es
vi r
Ph
b&
on
Me
tie
ss
En
La
ct i
A
e
Pa
/
f
t
In
mi
Ad
Regulatory Domains
© 2013 B. Ettinger MD/MPH
43
The frequency of regulatory violations changes,
when the regulations are
combined into functional groups
of related activities and accountability.
© 2013 B. Ettinger MD/MPH
44
Federal ASC Conditions for Coverage
(listed in order of publication, State Operations Manual)
1. General Conditions
7. Medical Staff
2. Compliance with Federal,
8. Nursing Services
State, Local Laws
3. Governing Body,
Management
4. Surgical Services
5. Quality Assessment/
Performance Improvement
6. Environment of Care
9. Medical Records
10. Pharmacy Services
11. Laboratory & Radiologic
Services
12. Patient Rights
13. Infection Control
14. Admission, Assessment,
Discharge
(57 “Standards” (sub-regulations); 1-14 for each Condition )
© 2013 B. Ettinger MD/MPH
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Realigning the CfCs into
Functional SYSTEMS of Accountability
Functional Grouping
Domain of Accountability
1. Governing Body; QAPI;
General Requirements & Laws
● Facility oversight
2. Medical and Nursing Staffs
● Verification of credentials,
competency; provision of care
3. Infection Control and
Environment of Care
● “Safe, sanitary, functional”
environment
4. Surgical Services; Admission,
Assessment and Discharge
● Clinical evaluations
and procedures
5. Pharmacy, Laboratory,
and Radiologic Services
● Ancillary services
6. Medical Records
and Patient Rights
● Required documentation of
patient care, and services
© 2013 B. Ettinger MD/MPH
46
REGULATIONS
GROUPED BY
FUNCTION
Violations
Total (%)
Conditions (n)
Standards (n)
(Rounded)
Governing Body;
QAPI; Laws & Regs
48
88
136 (34)
Medical Staff;
Nursing Service
28
56
84 (21)
Infection Control;
Environment
9
50
59 (15)
Lab, Radiology;
Pharmacy
17
28
45 (11)
Surgery; Admit/
Assess/ Discharge
5
34
39 (10)
Patient Rights;
Medical Records
2
34
36 (9)
109
290
399
Totals
© 2013 B. Ettinger MD/MPH
47
REGULATIONS
GROUPED BY
FUNCTION
Violations
Total (%)
Conditions (n)
Standards (n)
(Rounded)
48
88
136 (34)
28
56
84 (21)
Infection Control;
Environment
9
50
59 (15)
Lab, Radiology;
Pharmacy
17
28
45 (11)
Surgery; Admit/
Assess/ Discharge
5
Patient Rights;
Medical Records
2
34
36 (9)
109
290
399
Governing Body;
QAPI; Laws & Regs
Medical Staff;
Nursing Service
Totals
© 2013 B. Ettinger MD/MPH
70%
55%
34
39 (10)
48
Field Experience – Acute Care Hospitals

Investigation of 4 maternal and 5 fetal deaths
during labor and delivery, 1 each in 9 different,
unrelated hospitals in LA County.

Findings of non-compliance were similar across
all hospitals
•
•
•
repetitive clustering of specific system domains
failure to develop/implement policies & procedures
failure to implement/enforce internal rules and
regulations
© 2013 B. Ettinger MD/MPH
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Multiple Errors …

Occurred at different operational levels within each
hospital
•
administrative, clinical, and support

Exposed multiple concurrent, unsafe systems (latent)
and practices (active errors)

Three regulatory domains were consistently cited
•
•
•
© 2013 B. Ettinger MD/MPH
Governing Bodies (Administration)
Medical Staffs
Nursing Services
50
REGULATIONS
GROUPED BY
FUNCTION
Violations
Total (%)
Conditions (n)
Standards (n)
(Rounded)
Governing Body;
QAPI; Laws & Regs
48
88
136 (34)
Medical Staff;
Nursing Service
28
56
84 (21)
Infection Control;
Environment
9
50
59 (15)
Lab, Radiology;
Pharmacy
17
Surgery; Admit/
Assess/ Discharge
Patient Rights;
Medical Records
Totals
© 2013 B. Ettinger MD/MPH
55%
28
45 (11)
5
34
39 (10)
2
34
36 (9)
109
290
399
51
Key Points for QAPI
from Surveys and Investigations

Every activity in the ASC should be reviewed/included
in the QAPI program
•
clinical, operations, administration

Governing Body (GB) has absolute responsibility,
especially for the QAPI program (Regulation)

Most GBs do not fully appreciate the QAPI concepts
or methodology (interviews and GB meeting minutes)
•
•
•
therefore not properly implemented
labor & time intensive (time is $$$)
critical violation
© 2013 B. Ettinger MD/MPH
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Governing Body; QAPI; Laws and Definitions

Domain
•
•

facility oversight
includes Life/Safety (Building Codes)
Accountability (quality indicators; framework for systems of care)
•
•
•
•
•
Legal responsibility and accountability
Transfers
Contracts
Disaster preparation
Everything Else
© 2013 B. Ettinger MD/MPH
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Medical and Nursing Staffs

Domain
•
•

verification of credentials and competency
provision of care
Accountability (quality indicators; framework for systems of care)
•
•
•
MD - How to credential; initial proctor; peer review
for re-credential; vs. GACH medical staff letter
(why every 2 years for ASC)
RN, others – annual competency & skills assessment
Staff – licenses; scope of practice vs. assignment of
duties
© 2013 B. Ettinger MD/MPH
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Infection Control & Environment of Care

Domain
•

“safe, sanitary, functional” effective environment
Accountability
•
•
•
•
•
(quality indicators; framework for systems of care)
Survey w/in survey
Qualified (training, experience) in-house designated
person for day to day (IC consultant – recommended)
Includes elements of life/safety for environment
(e.g. HVAC, etc.)
Adverse events related to unsafe environment
Cross refer to Pts’ Rights to receive care in safe setting
(Q232)
© 2013 B. Ettinger MD/MPH
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Surgical Services; Admission, Assessment,
and Discharge

Domain
•

clinical evaluations and procedures
Accountability (quality indicators; framework for systems of care)
•
•
•
•
•
•
•
3 patient assessments – who performs
surgical checklists/time out
provision of anesthesia and monitoring vital signs (scope
of practice) vs. assignment of duties
emergency equipment, supplies
clinical assessments at discharge
specific discharge instructions
discharge to responsible adult (unless waived by MD)
© 2013 B. Ettinger MD/MPH
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Pharmacy, Laboratory, and Radiology

Domain
•

ancillary services
Accountability (quality indicators; framework for systems of care)
•
•
•
•
Dedicated oversight for these services in accordance
with laws and regulations
Includes individual &/or facility licenses & permits
Lab – defined policies for indicated lab studies before
procedures and emergencies
Radiology - GACH requirements
© 2013 B. Ettinger MD/MPH
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Patient Rights & Medical Records

Domain
•
•
•

Protect patients
Ensure adequate care through required actions
Required documentation
Accountability (quality indicators; framework for systems of care)
•
•
•
•
•
•
•
DO NOT MINIMIZE IMPORTANCE - 26 pages in SOM
Provision and Posting of Rights
Informed Consent & Advance Directives
Grievances; Privacy & Safety
Confidentiality of clinical records (HIPAA)
Protection of medical records – secure storage to protect
confidentiality, integrity, and availability
other
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Joint Commission Perspectives, 2013;33(4);1
Top 10 ASC Compliance Domains & Issues, 2012

Medical Staff - Physician Credentialing
•

Pharmacy and Medication Control
•

Unsafe…storage of medications; use of lookalike/sound-alike medications; management of highalert and hazardous medications
Infection Control / Environment
•

Granting initial, renewed, or revised clinical privileges
Risk from… medical equipment, devices, supplies;
acquiring/ transmitting infections; CDC/WHO hand
hygiene guidelines; hazardous materials & waste;
conditions in the environment
Universal Protocols
•
Time-out before the procedure
© 2013 B. Ettinger MD/MPH
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Selected Issues
Just Culture
Patient-Centered Care
Systems of Care
“Patient Safety and ‘Just Culture:’
A Primer For Health Care Executives”
Marx D, 2001 www.ahrq.gov



Competent professionals make mistakes
C
• “To Err is Human” - inadvertent, unplanned, unintentional o
n
At-risk behavior - competent professionals develop
t
unhealthy “norms“
i
• convincing oneself that corners can be cut
• choosing shortcuts that lead to increased risk – (entropy) n
• "routine rule violations”
u
u
Reckless behavior - choosing to put others in harm's way
m
•
knowingly performing tasks /procedures beyond the scope
of one’s licensing and training
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Culture of Safety - Human Factor Engineering
“Righting Wrong Site Surgery” Carayon et al. Jt Comm J Qual Saf 2004:30(7)

Interactions of humans and a “work system”
•
•

tasks, tools, technologies, physical environment,
organizational conditions
human strengths, capabilities, limitations
How systems work in actual practice
•
the "fit" between user, and the work system

Minimize - risk of error in complex environments

Optimize - system performance, quality, safety

For QAPI - how change (benchmarking) affects the
processes of care
© 2013 B. Ettinger MD/MPH
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Establishing a “Just Culture” for Safety
Adapted from Dana-Farber Cancer Institute, Principles of a Fair and Just Culture
(www.dana-farber.org/.../principles-of-a-fair-and-just-culture.pdf)
 open interdisciplinary discussion of untoward
events (include patient, family)
• respect, compassion, support for all staff
• individuals accountable to job responsibilities,
not system flaws
 improve the workplace
• best fit – between worker, job duties, scope of
practice, skills and competencies
• environment, actions, attitudes - monitored for
effectiveness to reduce errors (QAPI)
• ongoing education, interventions, safety-based
leadership (QAPI)
© 2013 B. Ettinger MD/MPH
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Just Culture of Care / Employee Satisfaction

Employee satisfaction - translates to patient
satisfaction
•
•

Employee assessment - ASC safety & quality of care
•
•

patients recognize when staff members are not
happy
significant association with staff attitudes, body
language, and cross talk
would you recommend family, friend?
if not, why not?
Leadership Issue for QAPI !
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Patient Surveys

Older surveys - factors unrelated to care
•
•

New CMS hospital survey - focus on patient-centered
experiences (1)
•

strongly correlated with better outcomes (2)
CMS developing ASC survey on patient-reported
experiences and outcomes (3)
•
•

e.g., fulfillment of desires
no correlation with processes and outcomes
pain; nausea & vomiting; infection
deep vein thrombosis; pneumonia; urinary retention
Consider revised patient survey now – include in QAPI !
(1) Manary NEJM 2013; 368:201; (2) www.cms.gov/Medicare/Quality-InitiativesPatient-Assessment -Instruments; (3) Federal Register, 1/25/13, p 5459
© 2013 B. Ettinger MD/MPH
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“Shadowing patients and families during
the Care Experience”
DiGioia AM, 2013. Univ. Pittsburg Med Ctr. Patient & Family Centered Care
(www.pfcc.org/shadowing-resources)

For Internal QAPI (CMS “Tracer” Observations)
•
•
•
•
•
how care givers interact among themselves and
patients/families
flow of care - how long each process takes
comments and concerns raised by care givers
comments, questions, and concerns raised by
patient & family
how helpful are discharge instructions to patient &
family
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AHRQ - Project R E D
Re-Engineered Discharge - for Hospitals

Reduce preventable readmission
•
•
•

patient-centered, standardized approach to
discharge planning
prepare for self care
education and post-hospital follow-up
Align organizational values with patient demands
•
•
•
•
care coordination
patient centeredness
organizational culture
transparency and organizational learning
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AHRQ Project RED
PATIENT SAFETY
CARE
COORDINATION
PATIENT
CENTEREDNESS
ORGANIZATIONAL
CULTURE
TRANSPARENCY &
ORGANIZATIONAL
LEARNING
Reliability
Foundational Elements
Overview of
Safety,
Harm
Human Factors
& Cognitive
Psychology
Culture
Just Culture
Teamwork &
Communication
Leadership &
Facilitation
Adapted from Patient Safety Leadership Fellowship Brochure, 2013-2014. © 2011 American Hospital
Association. American Hospital Association/National Patient Safety Foundation. (PSLF 2013-2014 Brochure©FINAL.pdf)
2013 B. Ettinger MD/MPH
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AHRQ - Safety Program for Ambulatory Surgery
http://ascsafetyprogram.org

Support CMS’ Conditions for Coverage
•
•
especially QAPI, infection control
Quality Reporting Program.

Improve quality, teamwork and communication
within ambulatory settings, nationally

Benchmarking

Expected outcomes
•
•
•
•
improve patient safety culture
enhance teamwork and communication
improve patient, provider, and staff satisfaction
reduce SSIs and complications
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PATIENT SAFETY
TRANSPARENCY &
PATIENT Assessment/
ORGANIZATIONAL
Quality
ORGANIZATIONAL
CENTEREDNESS
CULTURE
LEARNING
Performance Improvement
is integral
to
an
ASC’s
Reliability
organizational value systems
CARE
COORDINATION
Foundational Elements
Overview of
Safety,
Harm
© 2013 B. Ettinger MD/MPH
Human Factors
& Cognitive
Psychology
Culture
Just Culture
Teamwork &
Communication
Leadership &
Facilitation
70
System of Care

Integration and coordination of factors to address
clinical problems and situations
•
•
•
•
•
individual skills, competency, and performance
processes of care
technology
administrative oversight
other unique factors to the system under evaluation
© 2013 B. Ettinger MD/MPH
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Systems Approach
Agency for Healthcare Research and Quality

prospectively identify situations or factors with potential
for error

implement changes to reduce the likelihood of
occurrence and/or severity of impact
•

error analysis - predictable human failings in the context of poorly
designed systems
focus on human factors when designing protocols,
schedules, etc.
•
•
more likely to be effective than efforts to create flawless providers
avoids individual blame, reprimand, corrective efforts, etc.
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Robert Wachter (ACOG ACM 2009)
Old Model of Patient Safety

Culture of low expectations
• “Perfection is not possible.”
•
•
•
complexities, technology
machinery vs. human factors
medication similarities and numbers
 “Unless I’m sure it’s wrong – it must be right.”

Culture of blame – individual’s accountability
© 2013 B. Ettinger MD/MPH
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Robert Wachter (ACOG ACM, 2009)
New Model of Patient Safety

Use of Checklists (Regulations)
•
•
•
•

Science of Safety
•

simplify
standardize
performance expectations
accountable
analyze and learn from mistakes
“Unless I’m sure it’s right – it must be wrong.”
© 2013 B. Ettinger MD/MPH
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Conclusions

“Left to their own devices – things can go wrong.”

Risks to patient safety increase when
•
•
•

staff are unprepared to manage complications
adverse events are not anticipated
“routine” practices not regularly evaluated on
ongoing basis.
Compliance (with regulations and accreditation
standards ) = risk management
© 2013 B. Ettinger MD/MPH
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Increased Governing Body oversight for …
•
•
•
ongoing internal review of all processes and
procedures
pre-emptive planning
standardizing systems and process of care
•
implementing and enforcing minimum standards
to eliminate substandard/ unsafe care
•
implement strategies for safer environments and
responses to unexpected events
•
monitoring compliance
Consider “the cost of poor quality”
“You can pay me now, or you can pay me later!”
© 2013 B. Ettinger MD/MPH
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Why it’s Quality …

Regulations and Interpretive Guidelines can be confusing
•
•
•

Advantage of the Guidelines and Survey Procedures
•
•
•

convoluted
redundancies
multiple cross references
text-book for safe systems and practices
constant updating (vs. static text that is updated every few years,
but outdated at time of re-publication)
supplemented by AFLs, S&C Letters, feed-back from CMS & CDPH
Implement as a functional and integrated clinical,
operational, and administrative system.
© 2013 B. Ettinger MD/MPH
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Systems Defenses
The holes in Havarti
cheese are smaller
than in Swiss cheese.
Systems
Failures
“The bigger the holes,
the weaker the
defenses against
system failures.”
Getting to Havarti. Veltman
Obst Gynecol 2007;110:1147
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Systems Defenses
Systems
Failures
”Make the holes
smaller. Lessen
the risk for adverse
outcomes at every
level of care and
service.”
Minimize the risk
of harm.
Getting to Havarti. Veltman
Obst Gynecol 2007;110:1147
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“The obstacles lie in beliefs,
intention, cultures, and choices.
All of these can change.”
Donald Berwick
Former CMS Administrator
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