Womack Army Medical Center, Fort Bragg, NC
“Committed to Those We Serve”
Quality System Essentials
• Quality Control – provides feedback to
operational staff about the state of the process
that is in progress.
– Acceptable – continue with process
– Unacceptable – stop until a problem is resolved
• Quality Assurance – activities that are not tied to
the actual performance of the process.
– Retrospective review and evaluation of operational
performance
• Quality Management – interrelated processes in
the context of the organization
– Leadership role in commitment to quality
– Encompasses the quality systems approach
Quality System Essentials
•
•
•
•
•
•
•
•
•
•
•
•
Documents and Records
Organization
Personnel
Equipment
Purchasing and Inventory
Process Control
Information Management
Occurrence Management
Internal and External Assessment
Process Improvement
Customer Service
Facilities and Safety
Quality System Essentials
• Quality Management as an Evolving
Science
– The principles and tools in use today will
change as research provides new knowledge
of organizational behavior, as technology
provides new solutions, and as the field of
laboratory medicine presents new challenges
» AABB Technical Manual – 15th ed
Quality System Essentials
QSE Tools
Monthly QA Checklists
• Submitted monthly by section supervisors
• Summary of their QA activities
– QC/QC reviews
– Preventive Maintenance
– Timed activities
• Weekly, monthly, quarterly, semi-annual, annual
– Corrective actions taken
• Reviewed by Quality Manager
• Reviewed by section’s Medical Director
• Which QSE does this address??
QUALITY ASSURANCE CHECKLIST
MONTH:___________
YEAR:_______
Weekly
Review
By/Date
Review of Hematology Quality Control
Charts
Spun Hematocrit
Sickle-Chex
15 Minute ESR
60 Minute ESR
Retic QC Chart
Fertility QC Chart
FDP QC Chart
Atlas Level 1
Atlas Level 2
Kova-Trol Level 1
Kova-Trol Level 3
Corrective Action Control Logs
Parrallel Testing Logs
Review of Hematology Maintenance Charts
Microscopre Maintenance
Refrig/Freezer Temperature
STA-1 Daily
STA-1 Weekly
STA-2 Daily
STA-2 Weekly
Centrifuge Maintenance
LH 750-1
LH 750-2
Clinitek Maintenance
Nikon Maintenance
Eye Wash Check
Microhematocrit
MIdasII Maintenance-Stainer
ESR Maintenance Log
QA Coordinator:_________________
Weekly
Review
By/Date
Weekly
Review
By/Date
Weekly
Review
By/Date
Monthly
Review
By/Date
Quality System Essentials
Document Control
• Document Control Standard Operating
Procedure (SOP)
– Standard format for SOPs and Forms
– Matches up with items on the control logs
– Only the current version in use
• Document Control Logs
– Location, version, reviews
• Forms Control Logs
• What QSE does this represent?
WOMACK ARMY MEDICAL CENTER
DEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310
Copy
MCXC-PA-QM
14 January 2008
STANDARD OPERATING PROCEDURE
DOCUMENT CONTROL
I.
PURPOSE: To establish a uniform system of document control throughout the
Department of Pathology and Outlying Clinics. This system will provide a more
organized tracer system for location of policies and procedures. This will ensure the most
up to date version is in place at all locations.
II.
PRINCIPLE: The laboratory document management system has been implemented to
ensure that all documents in use are written in the approved formats, reflect the current
version, and are reviewed and approved by the appropriate individuals in a timely
manner. Generally, procedures are reviewed by the Quality Manager and forwarded to
the laboratory manager and the responsible pathologist for signature.
III.
APPLICABILITY: This procedure is applicable to all Department of Pathology and
Outlying Clinic personnel who read, write, or review standard operating procedures
(SOP) and policies for their respective laboratories.
IV.
PROCEDURE:
A. Procedures/Policies Control
1. Prior to implementation, all policies and procedures require approval by the
medical director of the respective section and the laboratory manager.
2. Personnel affected by the policy/procedure and any revisions thereafter will
read and acknowledge their understanding by signature and date. Procedure
version or revision will be designated by the date in the header.
3. Policies and procedures will be managed and distributed to the appropriate
locations by the proponent. The proponent will be designated in the header of the
SOP following the department designation –PA.
4. The proponent (section supervisor) of the SOP will maintain a control log of
all procedures and policies that they are responsible for. When more than one
copy of the SOP is required, the first copy will remain with the proponent.
Section: Safety (Admin.)
Copy
Number
1
2
3
4
5
6
7
8
9
1
2
3
4
5
6
7
8
9
Location
Safety SOP
Manual
Hematology
STAT
Histology
Clark HC
Joel HC
Robinson HC
BDC
Laboratory
(Phlebotomy)
Safety SOP
Manual
Hematology
STAT
Histology
Clark HC
Joel HC
Robinson HC
BDC
Laboratory
(Phlebotomy)
Updated: 19 Jul
2-Jul-07
2004
CPT Tonia Urick, 71A, MS
Updated: 22 Jan 2008
Joanna Horne, MT, ASCP
SOP Name
Last
Revision
Review
Review
Review
General Laboratory Safety
25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 08
Chemical Hygiene Plan
25 Jan 07 22 Feb 07 25 Jun 07 22 Jan 08
Review
WOMACK ARMY MEDICAL CENTER
DEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310
Hematology Section
QUALITY ASSURANCE CHECKLIST
Body of Form
HEM FORM 39
December 12, 2007
Quality System Essentials
Forms Control Log
LIS Form # Form Date
Form Name
Associated SOP(s)
1
2
3
4
5
May 9, 2006
May 9, 2006
May 10, 2006
May 25, 2006
May 11, 2006
Computer/Printer Maintenance
Specimen Master Log Review Checksheet
Corrective Action Report
Action Needed Form
Automated Patient Result Verification
Computer/Printer Maintenance
Result Review and Error Procedure
Result Review and Error Procedure
Result Review and Error Procedure
Result Review and Error Procedure
7
May 27, 2006
CHCS Training Checklist
CHCS Training SOP
Quality System Essentials
Audit Tool
• Audit schedule – annual
– Cross reference monthly QA Checklist to make sure
original documents reflect the items listed on the QA
Checklist
– Spot check document control accuracy
– Annual/Semi annual Competency audit
– Quality Control records and corrective action
documentation
– Phlebotomy Area – Patient identifiers, safety, HIPAA
• Unannounced audits – based on observation
• Which QSE does this address?
Quality System Essentials
Quality Management Audits
YEARLY AUDIT SCHEDULE
JANUARY
FEBRUARY

Chemistry –
QC Audit 1st shift

Hematology –
QC Audit 1st shift

SOP updates

SOP updates
MAY

Outlying Clinics –
QC & QM (weekly)
Audits, Document
Control Forms
SOP / Action Comparison
(SOP matches practice)

JUNE

SEPTEMBER

MARCH
Hematology –
QM (weekly) Review,
Document Control
Forms
Bi-Annual Review of QM
Yearly Planning Calendar
– (proficiency testing not
on survey)

Microbiology –
QC & QM (weekly)
Audits
JULY

OCTOBER

Stat Lab –
QC Audits
APRIL
AUGUST
Chemistry –
QA (weekly) Review
Document Control
Forms
NOVEMBER

Phlebotomy Room
Observation / Audit

Stat Lab –
QA (weekly) Review

Safety SOP Review
DECEMBER

CAF Review –
All departments
Quality System Essentials
Occurrence Management
• DA4106 (Incident report)
– Log item and resolution
– Interdepartmental
• Lab generated
• Generated Outside Dept of Pathology
• Quality Management report
– Internal to Department of Pathology
– Errors caught prior to release of results
• What QSE does this represent?
Location
Date
TYPE OF ERROR (Check all that apply)
Pre-Analytic Errors
Analytic Errors
Order Error
Method/assay error
Order missed
Wrong test ordered
Test ordered on wrong patient
Cancellation error
Other order error
Specimen collection Error
Specimen mislabeled/unlabeled
Wrong container or tube
Wrong patient drawn
Delay in collection
Instrument problem
Faulty reagent/standard/etc
Incorrect/expired calibration
Technical Error
Misinterpretation/misidentifcation
Dilution/pipetting error
Calculation error
Run accepted-QC out of range
Result accepted-outside linear limits
Sample mix-up
No initials/date/time for collection
Transcription/Entry Error
Specimen not received in lab
Other
Specimen contaminated with fluids
Post-Analytic Errors
Processing Error
Delay in testing/sending to other site
Specimen lost
Courier delay
Other
Delay in reporting
STAT/Critical not called/documented
Other
BB entry/issue/processing Error
 - Patient Safety or Quality Issue/Concern
Description of Occurrence (Include person identifying error):
Specimen Saved for further investigation? __Yes __No
Amended Report? (If so, must be attached)__Yes __No
This Form Completed By:
____More on Back
Specimen Recollected? __Yes __No
POC for amended report ______________
Corrective Action and Suggestions for Improvement (Include steps taken):
____More on Back
Date
Section
on/pip
terpre
isiden
error
tificati
on
Transcription Entry
errors
PostAnalytic
Errors
BB E
rrors
in Re
portin
g
Critic
al n o
tc
docu
mente alled and/o
d
r n ot
Othe
r
errors
Analytic Errors
Delay
Entry
Technical Errors
iption
Method/ Assay
Errors
Trans
cr
lation
error
Run a
ccepte
d-QC
out o
f rang
Resu
e
lt acc
epted
-outs
ide lin
Samp
ear li
le mix
mits
-up
eting
tation
/m
Pre-Analytic Errors
Calcu
Diluti
Processing
Errors
Misin
Specimen Collection Errors
Instru
m
Fault ent Proble
y rea
m
gent/
Incorr
stand
ect/e
ard/e
xpire
tc
d cali
bratio
n
Spec
in tes
ting/s
endin
g to o
imen
ther s
mispla
ite
Couri
ced
er de
lay fr
om o
Othe
ther s
r
ite
s
Order Errors
Delay
imen
misla
beled
Wron
/unla
g con
beled
taine
r or tu
Wron
be
g pati
ent d
ra
w
Delay
n
in coll
ection
No in
itials/d
ate/tim
e for
Spec
collec
imen
tion
not re
ceive
Spec
d
imen
conta
mina
ted w
Othe
r
ith flu
id
Spec
Orde
r Mis
sed
Wron
g Tes
t Ord
ered
Test
ordere
d on
wron
g pati
Canc
ent
ellatio
n Err
or
Othe
r Ord
er Err
or
Quality System Essentials
Quality Monitoring Report Log
Post-Analytic Errors
BB
Errors
Description of error
Quality System Essentials
Proficiency Testing
• Is your testing process in control?
– Measuring system
– Technical competence
– Clerical
• Investigation of failed proficiency testing
– Use a comprehensive form
– Determine root cause
– Prove you can obtain the correct result
• What QSE does this address?
Department of Pathology
1 Dec 07
Chief
Department of Pathology
COL Bradley Harper
Office of the Chief
Laboratory Manager
LTC Linda Guthrie
Decentralized Laboratories
Vera Claude
Accreditation oversight
Laboratory NCOIC
MSG Larry Reyes
Secretary
Lynn Salley
QI Coordinator
Robin Wein
Point of Care Coordinator
Jackie Vennero
Quality Assurance
Joanna Horne
Supply
Mary Martin-Mitchell
SGT Carpenter Anthony
Anatomic Pathology
Laboratory Manager
LTC Linda Guthrie
Clinical Pathology
Chief
MAJ Branch
Laboratory Manager
LTC Linda Guthrie
Transcription
OIC Clinical Pathology
VACANT
Cytology
Medical Director
CPT Foster
Civilian Supervisor
Walter Thornton
Chief
MAJ Charles Scott
NCOIC Cytology
SGT Delena Roper
BioSafety Laboratory
Laboratory NCOIC
MSG Larry Reyes
NCOIC Clinical Pathology
SFC Cassandra Maxwell
Laboratory Manager
LTC Linda Guthrie
OIC BSL
CPT Krishnaswamy
BSL Supervisor
Patricia Dempsey
Microbiology
Vacant
Hematology
Rhonda Tucker
Histology
Civilian Supervisor
Mona Wheat
Chemistry
Bonnie McGrady
Autopsy
Medical Director
MAJ Branch
STAT Lab
Linda Thompson
Transfusion Medicine
Blood Donor Center
Laboratory Manager
LTC Linda Guthrie
OIC Blood Donor Center
MAJ Jason Corley
Quality Assurance
Transfusion Medicine
Karen Royster
Civilian Supervisor
Vacant
NCOIC Blood Donor Center
SGT Isom, Cherise
Transfusion Services
Laboratory Manager
LTC Linda Guthrie
Medical Director
MAJ John Schaber
Pathology Support
Quality Assurance
Transfusion Medicine
Karen Royster
Shipping, Receiving, HIV
Shanika, Reeves
Which QSE is addressed?
Outpatient Collections
Shanika Reeves
Medical Director
MAJ John Schaber
Civilian Supervisor
Shannon Grovenger
OIC Blood Donor Center
CPT Jason Corley
Quality System Essentials
Personnel
• Gains and Losses
• New Employee Orientation
– Learning methods
•
•
•
•
AV- Audiovisual
V- Verbal
R-Review of Documents
I-In service
• Training
• Competency assessment
– 6 month
– Annual
ACTIONS
Leadership Introductions
Tour & Staff Introductions
Lockers
Supply Room
Admin/Reception
Break Room
Location of SOP’s/Policies & Regulations.
Safety Manual
QA Manual
CHCS Manual
MSDS/ Hazardous Material Storage Location
DEPARTMENT POLICIES
Hours
Leave
Personal Items/GOVT property Security
Essential Employees/ Inclement weather
Telecommunication/ Internet usage:
Directories/Paging/Roster sites
Hospital Parking Policy
Location & use of Emergency Red Power Outlets
PERFORMANCE
Job Description
Performance standards
Personal conduct
Rating Scheme
Initiate Competency Assess. File -6pt folder
CHCS ACCESS
System Administrator (Laboratory)
Register for AKO Account
Register for WAMC Badge and Network access (WAMC form 25-1U)
SAFETY
Fire Alarm Code (Bldg B. zone 06-07)
RACE/PASS
Evacuation rally point -(Back loading dock)
Fire alarm/ extinguisher locations
Emergency eye wash/showers
MSDS/HAZMAT storage
Code Responses (Yel, Blue, Orange, Purple, Silver, Pink, Red, Gold, Green)
Personal Protective Equipment usage
Needle Stick Procedures-Packets
Safety Accident Procedures- Packets
Use of ABC cart system
Isolation Techniques/ Ward rounds
TRAINING
HIPAA online training
Anti-terrorism training
Hospital Orientation Scheduled
COMPETENCY
METHOD
LEVEL
VERIFICATION
10. Observance of Lab Safety policies.
11. Oversees MLT training and ensures students meet
accreditation standards.
12. Ensures staff is trained in all areas of the Chemical
Hygiene Plan and EPP.
Verification Method Codes:
C-Course/Class Presentation
D-Demonstration
G-Group Discussion/Case Study
NA-Not Applicable
O-Observe Daily Workflow
S-Self Assessment
V-Verbalizes Knowledge
I-In-service
M-Mock Survey/Drill
W-Written Example
Q-QI Monitor
R-Review of Paperwork/QC/SOP
Competency Level:
E-Exceeds Expectations
S-Satisfactory
N-Needs Improvement
The above named employee is competent to perform the assessed skills on the Competency Assessment – Section Supervisor
without/with listed exceptions. If any exceptions are listed, attach a separate sheet of paper listing the exceptions and plans for
remediation.
____________________________________
__________________________________________
Signature
Date
Lab Manager Signature
Date
Quality System Essentials
QI Monitor
SUBJECT
POC
OPENED
FREQUENCY
Blood Culture
Contamination
Rate
Ms. Dempsey
Jan 07
Monthly
CLOSED
LOG #7
Microbiology
ESTABLISHED THRESHOLD <3%
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
331
305
303
314
303
282
273
11
10
9
3.6%
3.5%
3.3%
NOV
DEC
2007
Total #
of Sticks
338
320
338
#Conta
mi
nates
12
6
13
5
9
5
16
% Cont
3.8%
1.8%
3.8%
1.6%
3.0%
1.7%
5.1%
6.00%
5.00%
4.00%
3.00%
% Cont
2.00%
1.00%
0.00%
JAN
FEB
MARCH
APRIL
MAY
JUNE
JULY
AUG
SEPT
OCT
Which QSE is addressed?
NOV
DEC
Quality System Essentials
Integration into QI Program/Minutes
• QI Worksheet
– Broken down by QSE
– Submitted monthly
• By section supervisors
• One week prior to QI meeting
• Collated by Quality Manager
– Presented at QI meeting
– Submitted as the QSE attachment to the minutes
WOMACK ARMY MEDICAL CENTER
DEPARTMENT OF PATHOLOGY
FORT BRAGG, NC 28310
Quality Improvement Report Form
I. The report below is submitted by the _____________________ section for inclusion in
the minutes for the (month) __________________QI meeting.
II. Old Business
QI Monitors/Issues:
TITLE:
QA LOG #:
(Circle one)
Sentinel Indicator
New Issue
Old Issue
FINDINGS:
CONCLUSION:
RECOMMENDATION:
ACTION:
EVALUATION:
III. New Business
A. Personnel
1. Gain/Losses:
2. Training Completions:
Individual ___________________ Completely Trained for __________________
3. Competency Assessments:
Individual _____________________ Assessed for __________________
4. Continuing Education Report (see attached attendance roster)
Class _________________________ Instructor______________________
B. Equipment
1. Demonstrations
2. Validations
3. Issues
C. Purchasing and Inventory
1. Supply Issues
2. Contracts
D. Process Control
1. Proficiency Testing
Survey ____________# Responses____________#Acceptable______________
2. Monthly QAP QA report form submitted
3. SOP Updates
E. Documents and Records
-archived/updated/document control
F. Information Management
-Upgrades/downtime/issues
G. Occurrence Management
- DA4106
H. Assessments
1. Point of Care Testing report
2. Internal/External
I. Process Improvement
1. Utilization Review item(s)
a. TAT reports, etc
b. Workload
2. New Tests in evaluation
3. Teams/Committee activity
J. Customer Service and Satisfaction
1. Complaints – physicians, patients, staff
2. Satisfaction Surveys
K. Facilities and Safety
1. Infection Control report
2. Safety Report
Y
N
Comments: ________________________________________________________
_________________________________
Section Supervisor
Quality System Essentials
The Final Product
• QSE attachment to Department of
Pathology monthly QI minutes
• All 12 QSEs addressed during QI meeting
• Opportunity for discussions
– Add/correct items
• Laboratory Director and Laboratory
manager as well as staff are aware of all
quality activities at that snapshot in time