1. No category

2014 Continuing Compliance Master Series
Interim Self-Inspection: What is it and How to do it
John D. Olson, MD, PhD, FCAP
March 19, 2014
www.cap.org
Today’ss Presenter - John D.
Today
D Olson,
Olson MD,
MD PhD
Dr. John Olson graduated from the University of
Colorado and received his Medical Degree from
Georgetown University. Following his residency at the
Mayo Clinic he received his PhD degree from the
University of Minnesota. He is currently Professor and
Vi
Vice
Ch
Chair
i for
f Clinical
Cli i l Affairs
Aff i in
i the
th Department
D
t
t off
Pathology at the University of Texas Health Science
Center in San Antonio and is the Director of the
Clinical Laboratories for the South Texas Reference
Laboratories.
Dr. Olson served on the CAP Coagulation Resource
Committee from 1993-2004, serving as its chair 19992004. He is currently a member for the Continuous
Compliance Committee
Committee. Dr
Dr. Olson
Olson’ss academic
career has focused on issues of hemostasis and
thrombosis. He also has interest in quality
management in the laboratory.
© 2014 College of American Pathologists. All rights reserved.
2
Learning Objectives
A a result
As
lt off participating
ti i ti
iin thi
this activity,
ti it you will
ill be
b able
bl to:
t
o Explain the importance of the interim self-inspection
o Apply
pp y best p
practices to y
your interim self-inspection
p
o Describe how the interim self-inspection will help prepare
you for an unannounced on-site inspection
o Describe how the interim self-inspection
self inspection will help improve
laboratory quality and promote continuous compliance
with accreditation requirements.
© 2014 College of American Pathologists. All rights reserved.
3
Purpose of the Self
Self-Inspection
Inspection
• Ongoing compliance with the Standards
• Update
p
laboratory
yp
practice to comply
p y with current
checklist requirements
• Prepare for the next on-site inspection
• Laboratory improvement and better patient care
© 2014 College of American Pathologists. All rights reserved.
4
GEN 23584: Interim Self
GEN.23584:
Self-Inspection
Inspection
• Th
The laboratory
l b
t
conducts
d t an interim
i t i self-inspection
lf i
ti
and documents efforts to correct deficiencies
g that p
process.
identified during
© 2014 College of American Pathologists. All rights reserved.
5
GEN 23584 (Continued)
GEN.23584
•
NOTE: The interim self-inspection is an important aspect of
continuing education and laboratory improvement.
improvement The use of a
variety of mechanisms for self-inspection (residents, technologists or
other inspectors) is strongly endorsed. Self inspection by personnel
familiar with, but not directly involved in, the routine operation of the
l b
laboratory
t
section
ti
to
t b
be iinspected
t d iis a b
bestt practice.
ti
Documentation of performance of the interim self-inspection with
correction of deficiencies is a requirement for maintaining
y must document that p
personnel
accreditation. The laboratory
responsible for each laboratory section have reviewed the findings
of the interim self-inspection.
•
Evidence of Compliance:
•
Written evidence of self-inspection findings with records of corrective
action
© 2014 College of American Pathologists. All rights reserved.
6
Get a Fresh Look at Your Operations
Use the interim self-inspection to look at your
laboratory or have someone else look at your
laboratory as if seeing it for the first time.
© 2014 College of American Pathologists. All rights reserved.
7
Let’ss Get Organized
Let
Plan for completion
p
before y
your Self-inspection
p
Verification Form is due to be returned to the CAP:
1. Identify a Team Leader for your self-inspection
process ((t-60 days)
p
y)
2. The team leader will identify inspectors to perform
the self-inspection (t-45 days)
3 Perform inspection (t-30
3.
(t 30 to t-15
t 15 days)
4. Team meets to review findings
5. Summation Conference (t-7 days)
6. Mail self-inspection confirmation to CAP (t-7 to t-1
days)
7 Corrective action and documentation (t+30 days)
7.
© 2014 College of American Pathologists. All rights reserved.
8
Team Leader
• Someone with experience
p
with the inspection
p
process
• Has p
previously
y been a team leader or member of a
team inspecting another laboratory
• Has taken the Team Leader Training
g offered online
at CAP.org:
http://learning.cap.org/catalog/options/view/c
cf50d5a 9a33 438a 8872 469831d6194f
cf50d5a-9a33-438a-8872-469831d6194f
• An opportunity to lead a project
© 2014 College of American Pathologists. All rights reserved.
9
Self-Inspection
Self
Inspection Team Members
• Use supervisory staff, experienced non-supervisory
technical staff, residents, fellows
• Cross discipline lines when practical
- Cultivates new team members for future inspections
- Provides depth for unannounced on-site inspections
- Prepares staff for inspection interviews
- Elucidates weaknesses
• Explore exchange with other laboratories in your region
• All team members should take the inspector training at
CAP.org:
http://learning.cap.org/catalog/options/view/d9c451f3
-addd-4d09-b24a-5b1f83d27a3e
© 2014 College of American Pathologists. All rights reserved.
10
Initial Team Leader Meeting with Inspectors
1. Assignments and distribution of checklists
- Have the checklists provided for the inspection
- Be clear about the assignments for each team member
- Define any focus issues
2. Establish timing
- Timing is flexible so set precise goals
- Lay out the entire timeline
3. Define communication and “esprit de corps”
- New members will have questions. Provide them support
- Collegial process, inspector and laboratory are both
learning
© 2014 College of American Pathologists. All rights reserved.
11
Inspection Process
•
Focus Issues
o Prior inspection deficiencies, on site or self-inspection
− There is no reason for and there should not be
recurrence of prior deficiencies
o Known issues in your laboratory (products of your event
management program)
− Many of the events that occur in the laboratory are
related to accreditation requirements
− Check that all events have documented corrective
action; verify that you are compliant for accreditation
© 2014 College of American Pathologists. All rights reserved.
12
Inspection Process
• Focus Issues
o Common problems (deficiencies) found in
inspections of other laboratories
- We will review some common issues that are
found during
g inspections
p
g
generally.
y
- Data is a compilation of the findings of all CAP
inspections.
© 2014 College of American Pathologists. All rights reserved.
13
Inspection Process
• 2012: Common Deficiencies
o Among the checklist items, many laboratories
are cited for the same issues
o Comparing the current list of common
d fi i
deficiencies
i tto th
those off prior
i years, we find
fi d
that the most frequently cited deficiencies
are similar from one year to the next, and do
not necessarily involve new requirements
© 2014 College of American Pathologists. All rights reserved.
14
Inspection Process
Most Common Deficiencies in 2012
GEN.55500 Competency Assessment
GEN.20375 Document Control System
GEN.75400 Annual Fire Drill
COM.01700 Proficiency Testing (PT) Evaluation
COM.10000 Complete Procedure Manual
COM 01400 PT Attestation
COM.01400
Att t ti
Statement
St t
t
CHM.10100 Procedure Review
POC.06900 Competency Assessment
CHM 13600 AMR Validation
CHM.13600
V lid ti
COM.10300 Knowledge of Procedures
0
100
© 2014 College of American Pathologists. All rights reserved.
200
300
400
500
600
15
Inspection Process
Five Phase II Items Most Often Cited from the All Common
Checklist:
o COM.01100 Laboratory has procedure for grading
g intended to be graded,
g
, but which were
challenges
not
o COM.01500 Alternative Assessment
o COM.01600 Proficiency Testing Integration into
Routine Workload
o COM.01700 Proficiency Testing & alternative
assessment: evaluation and corrective action
o COM.10100 Procedure Manual Review had been
annual now at least every two years
annual,
© 2014 College of American Pathologists. All rights reserved.
16
Polling Question 1
While performing your self inspection, you are asked to
review the Proficiency Testing records.
records You find that your
Director has correctly signed every attestation sheet for the
past 2 years except for the A mailing of the CGL survey this
year.
year
What do you do?
A Cite a Phase II deficiency for failure to sign the
A.
attestation.
B. Issue a recommendation the laboratory has
established practice of signing.
C. This is minor, cite yourself for only a Phase I
deficiency.
© 2014 College of American Pathologists. All rights reserved.
17
Inspection Process
Most Cited Discipline Specific Deficiencies in 2012
POC.06900 Competency Assessment
CHM.13600
C
3600 Validation of Analytic
y Measurement Range
g
TLC.11425 Delegation of Director Duties
CHM.13800 Method Comparisons
MIC.11020 Quality
y Control Monthly
y Review
POC.07300 Daily Control Testing
TRM.31450 Method Comparisons
HEM.24000 Reagent
g
Labeling
g
ANP.12087 Cryostat Decontamination
ANP.08216 Formaldehyde Monitoring
0
100
© 2014 College of American Pathologists. All rights reserved.
200
300
400
500
600
18
Inspection Process
CHM.13600 (Phase II) Validation of the analytical
measurementt range (AMR) is
i performed
f
d with
ith matrixti
appropriate materials which include the low, mid and
high range of the AMR, appropriate acceptance criteria
are defined,
d fi d and
d th
the process is
i documented.
d
t d
Common reasons for citations:
o Did nott revalidate
lid t every 6 months
th
o Did not include materials than span the assay range
o Did not include all applicable analytes in the
validation process (e.g. blood gases, BNP, and TNI)
o New issue in Hemostasis that is generating questions
© 2014 College of American Pathologists. All rights reserved.
19
Inspection Process
TLC.11425 (Phase II) If the laboratory director has
delegated some functions to others
others, documentation
specifies the individuals and the specific activities so
authorized.
Common reasons for citations:
o No documentation
o Duties or individuals not included
o Delegated activities that must not be delegated
such as new procedure or policy review
o Letter/memo needs to be specific regarding the
duties that are being delegated
© 2014 College of American Pathologists. All rights reserved.
20
Inspection Process
CHM.13800 (Phase II) If the laboratory uses more
th
than
one instrument/method
i t
t/
th d to
t test
t t for
f a given
i
analyte, the instruments/methods are checked
against
g
each other at least twice a y
year for
correlation of results.
Common reasons for citations:
o Not performed twice per year
o Not including all the appropriate
instruments/methods
o No established criteria for acceptability
o Also
Al TRM
TRM.31450
31450 (Ph
(Phase II)
© 2014 College of American Pathologists. All rights reserved.
21
Inspection Process
MIC.11020
MIC
11020 (Phase II) Quality control data are
reviewed and assessed at least monthly by the
laboratory director or designee.
Common reasons for citation:
o No documentation
o Not completed monthly
o Not performed by a documented designee
o Also POC.07300 Managing controls for POCT
© 2014 College of American Pathologists. All rights reserved.
22
Inspection Process
ANP.23410 (Phase II) There is a documented
procedure for the routine decontamination of the
cryostat at defined intervals, and decontamination
records are evident.
Common reasons for citations:
o Lack of documentation
o Laboratories sometimes use uv or fog, but do not physically
wipe the cryostat down
o LLaboratories
b
t i aren’t
’t using
i
the
th cryostat
t t daily
d il and
d are unsure
of the frequency of decontamination
o Laboratories have a difficult time decontaminating once
per week due to high volumes and only one cryostat
available.
© 2014 College of American Pathologists. All rights reserved.
23
Inspection Process
ANP.08216 (Phase II) Formaldehyde and xylene
vapor concentrations are maintained below the
f
following
i
maxima,
i
expressed as parts per million,
i i
in
i
all areas of the Anatomic Pathology Department
where formaldehyde or xylene are used.
Common Reasons for Citations:
•
Laboratories sometimes don
don’tt do both the 15 minute and the 8
hour monitoring
•
Laboratories have small quantities of these chemicals and
believe that the requirement does not apply to them.
them
•
Do not repeat the monitor when changes have taken place in
the laboratory that could potentially increase exposure such as
changes
h
in
i production,
d ti
equipment,
i
t personnell
© 2014 College of American Pathologists. All rights reserved.
24
Polling Question 2
While performing your self inspection you find a procedure was
l t reviewed
last
i
d and
d signed
i
d 18 months
th previously.
i
l Your
Y
laboratory’s
l b
t ’
quality plan states that procedures are reviewed annually.
you do?
What do y
A. Current CAP regulations require review every 24 months so
this is compliant.
e laboratory’s
abo a o y s policy
po cy sstates
a es the
e review
e e iss to
o be every
e e y 12
B.. The
months. This is a Phase II deficiency.
C. The laboratory’s policy states the review is to be every 12
months. Write a recommendation to update the policy.
© 2014 College of American Pathologists. All rights reserved.
25
Inspection Process
Encourage
g inspectors
p
to:
o Spend time in the laboratory!
o Interview non-supervisory staff (bench techs,
phlebotomists,
hl b t
i t order
d entry
t personnel)
l)
− Structure the interim self-inspection to be
as similar to the on
on-site
site inspection as
possible:
− Interview non-supervisory personnel during
th self
the
lf inspection
i
ti
-- does
d
everyone know
k
the policies as well as the supervisors?
© 2014 College of American Pathologists. All rights reserved.
26
Inspection Process
Testing Readiness
o “If your supervisor were not here on the day of
the inspection,
p
how would y
you respond
p
if y
you
were asked by the inspector…”
− …for a certain procedure or practice?
− …where PT policies are located?
− …where the Chemical Hygiene plan is housed?
− …where
where the maintenance records are kept?
− …etc.
© 2014 College of American Pathologists. All rights reserved.
27
Inspection Process
• An Example:
p
What’s the p
problem?
• GEN.41067 (Phase II)
• No written policy.
• “D
“Does th
the LLaboratory
b
t
director review the
format of the report
p
on
a bi-annual basis?”
• N
No documentation
d
t ti
that this is occurring.
• I look at report formats
every day!
© 2014 College of American Pathologists. All rights reserved.
28
Inspection Process
The Lesson:
• Provide
documentation that
th activity
the
ti it is
i being
b i
performed.
• “If
If you didn
didn’tt
write it down, it
did ’t
didn’t
happen……”
• Failure to document
equals non
noncompliance.
© 2014 College of American Pathologists. All rights reserved.
29
Inspection Process
Famous Last Words
“Oh yes, we do all of that all of the time!”
Dr. I. M. Complacent,
p
Medical Director
Mediocre Laboratories, USA
When you are in
Wh
i a familiar
f
ili environment,
i
t same place
l
and
d activity,
ti it
day after day, you can overlook details, forget best practices
and become complacent.
Consistency is also an issue. Do all of the staff perform the same
procedures the same way.
© 2014 College of American Pathologists. All rights reserved.
30
Inspection Process
Safety
y
o Safety procedures and policies posted readily
available to all employees?
o Documentation of safety training to new
employees.
o During the Interim Self-Inspection,
Self Inspection interview
personnel regarding contents of the safety
manual.
− Choose several items to ask non-supervisory
staff.
© 2014 College of American Pathologists. All rights reserved.
31
Inspection Process
Competency Assessment
o During
D i
th
the fi
firstt year off patient
ti t ttesting,
ti
competency assessment must be performed
every six months.
o Competency must be reassessed at least
annually.
o Confirm all six elements are included for each
test system (if applicable).
o Managing Competency for POCT is a problem
i many iinstitutions.
in
tit ti
o PPMP now requires competency with the same
detail as others who p
perform testing.
g
© 2014 College of American Pathologists. All rights reserved.
32
Inspection Process
Point of Care Testing
g
o Inspection of POCT requires the use of the POCT
checklist and all applicable portions of the
L b
Laboratory
t
General
G
l checklist.
h kli t
o For accreditation, all analytes being measured
under the program/site are included in the live
CAP inspection.
o POCT is often overlooked in the self-inspection.
o Not in the Laboratory, but the Laboratory
provides oversight. Be sure all elements are
compliant
compliant.
© 2014 College of American Pathologists. All rights reserved.
33
Inspection Process
(GEN.20375) Elements of Document Control System
• Policies, procedures and processes (P/P/P) current
• Personnel have read the relevant documents
• P/P/P have been authorized by the director
• P/P/P reviewed annually by the director or designee
• Discontinued P/P/P are archived and quarantined a in
separate file
• Are all required elements present? Are Documents
current?
© 2014 College of American Pathologists. All rights reserved.
34
Polling Question 3
Your laboratory has a new director. She started as the
director just a month ago. As you review the procedures,
you
o note that onl
only one ne
new major re
revision
ision has occurred
occ rred
that she has signed. All other procedures have been
signed by the prior director.
What do you do?
A. The new director must only sign the new procedures from
her start date, not prior procedures.
B. Cite a Phase II deficiency. The new director is required to
approve and sign ALL procedures.
g all procedures
p
but is allowed a
C. The director must sign
“reasonable time” to complete the task.
© 2014 College of American Pathologists. All rights reserved.
35
Inspection Process
Team Leader Assessment of the Laboratory Director
and Quality Checklist
• Evaluate the qualifications of the Laboratory
Director.
• Assess the effectiveness with which that individual
implements and supports the Standards of the
Laboratory Accreditation Program.
• C
Conduct
d t th
the iinterview,
t
i
it can help
h l provide
id d
depth
th
for the on-site inspection.
© 2014 College of American Pathologists. All rights reserved.
36
Inspection Process
Team Leader Assessment of the Laboratory Director and
Q lit Checklist
Quality
Ch kli t
• Review documents:
o QM plan -- include review of specific monitors,
corrective actions.
o Organizational chart -- does it represent operations?
• H
Has th
there been
b
a change
h
in
i the
th Laboratory
L b
t
Director?
Di
t ?
o COM.10400: If there is a change in laboratory
directorship, the new laboratory director reviews and
approves (over a reasonable period of time) that
laboratory procedures are current.
− Create your own goals, write them down and
document
docu
e that
a you a
are
ep
progressing.
og ess g.
© 2014 College of American Pathologists. All rights reserved.
37
Inspection Process
Quality Management
• Your event management
g
program
p g
drives much of
your quality management
g
selection of indicators
• Thoughtful
• Corrective actions documented
• Director’s
Di
t ’ iinvolvement
l
t iin d
development
l
t and
d
management of Quality
© 2014 College of American Pathologists. All rights reserved.
38
Inspection Process
Review of Proficiency Testing
• Variant Proficiency Testing performance report
• “Drill down” troublesome analytes
• Alternative Assessment
• Do not share or refer Proficiency Testing results!
© 2014 College of American Pathologists. All rights reserved.
39
Inspection Process
Patient Safety
y Policy
y
• Rigorous adherence to patient identification
p
procedures
• Reporting of life threatening conditions/ critical
values
• Strategies for preventing medical errors
• Institutional approach
© 2014 College of American Pathologists. All rights reserved.
40
Inspection Process
H dli
Handling
off C
Complaints
l i t
• Honestly review the culture of your laboratory.
• Do a policy and procedure exist?
• Do the policy and procedure match actual
practice?
© 2014 College of American Pathologists. All rights reserved.
41
Team Meeting at Completion of Inspection
• Review all deficiencies identified during the
inspection
o Common issues may arise
o Discuss any
y issues about which an inspector
p
may
y
be uncertain
• O
Organize
g
the summation conference
© 2014 College of American Pathologists. All rights reserved.
42
Summation Conference
• Hold a formal summation conference
• Invite the leadership of the organization
p
Administration, Director of Organization,
g
o Hospital
Quality
o Your opportunity to shine
• Identify the strengths and quality of the laboratory
• Review the opportunities for improvement that have
been identified
o All inspectors or just the team leader
• Open and Close on a positive note
© 2014 College of American Pathologists. All rights reserved.
43
Paperwork
• Send to the CAP:
o Self
Self-inspection
inspection Verification Form
− Signed by Director
© 2014 College of American Pathologists. All rights reserved.
44
Corrective Actions
• Plan corrective action for all cited deficiencies
• Collect documentation that the corrective action
has addressed the problem
p
• Complete these tasks within ? days, fix the time
frame
• File the information for review by the next on-site
inspection team
• In 6 months, pull the file and document that the
corrective actions have been successful
© 2014 College of American Pathologists. All rights reserved.
45
Inspector Summation Report: Five Crucial Questions
At your on-site inspection, the inspection team leader
with
ith write
it a reportt iincluding
l di
th
the ffollowing
ll i
elements.
l
t
Consider these same elements as you conclude the
self-inspection process:
1. Does the laboratory meet the standards?
2. Is the Director qualified?
3. If no, is there a qualified supervisor for each
section?
4. Is administration satisfied?
5 Is the medical staff satisfied?
5.
© 2014 College of American Pathologists. All rights reserved.
46
What Inspectors Will Focus on About Your SelfInspection
• IInspectors
t
h
have b
been instructed
i t
t d tto review
i
the
th
results of the interim self-inspection
o Request list of cited deficiencies and scrutinize
documentation of corrective action
• Probing questions will be asked about the self
selfinspection
o How seriously did the laboratory take the
process?
o Were genuine concerns detected and
corrected?
© 2014 College of American Pathologists. All rights reserved.
47
Summary of Best Practices
• Involve multiple
p staff members in the self-inspection
p
• Make this a formal event for your laboratory
• Look at y
your laboratory
y as if y
you are seeing
g it for the
first time
• Ask questions of the bench technologists and other
staff
t ff
• Hold a summation conference encouraging all who
are able to attend
• Document corrective action for all deficiencies
cited
© 2014 College of American Pathologists. All rights reserved.
48
The Interim Self
Self-Inspection
Inspection – The Bottom Line
The laboratory
y is required
q
to p
perform the interim selfinspection, but don’t do the inspection because it is
required, do it because it will help you maintain and
improve the quality of your laboratory.
laboratory Sustaining
continuous compliance with the accreditation
standards is a challenge for Laboratories regardless of
size
i and
d complexity
l it and
d requires
i
a robust
b t quality
lit
program. The inspection process is an important
g part
p
of that p
program
g
and, when p
performed
integral
well, helps the continuous improvement of the
Laboratory.
© 2014 College of American Pathologists. All rights reserved.
49
Acknowledgements/Thank You
• Thanks to Dr. Renee Ellerbroek and Dr. Earle Collum
• Thanks to Continuous Compliance Committee
members, Accreditation Education Committee
members, Suzan Mraibie, Jean Ball, Rodney Stewart
and other CAP staff for assistance in preparing this
presentation.
presentation
• Thank you to our participants for their time.
Keep in mind the tool kit is available with the link
your site coordinator has received
© 2014 College of American Pathologists. All rights reserved.
50
Questions
© 2014 College of American Pathologists. All rights reserved.
51
Technical Assistance
http://www.cap.org
Email: [email protected]
p g
800 323 4040 ext.
800-323-4040,
t 6065
© 2014 College of American Pathologists. All rights reserved.
52
53