labman tqm -++
TRANSCRIPT
TOTAL QUALITY
MANAGEMENT
1
LEARNING OBJECTIVES
2
Appreciate the importance of TQM in the laboratory setting
Learn the different Quality System Essentials (QSE) and their importance in providing quality health services to the best level
What is Quality?
3
Essential to all aspects of health care are laboratory results that are:
accurate
reliable
timely
4
Achieving a 99% level of quality
means
accepting a error rate1%
5
In France a 1% error rate would mean everyday
14 minutes without water or electricity
50,000 parcels lost by postal services
22 newborns falling from midwives’
hands600,000 lunches contaminated by bacteria3 bad landings at Orly Paris airport
6
Result of 1% error
7
Laboratory errors cost in
time
personnel effort
patient outcomes
8
Negative consequences of laboratory error
unnecessary treatment; treatment complications
failure to provide the proper treatment
delay in correct diagnosis
additional and unnecessary diagnostic testing
9
Quality Management System
coordinated activities to direct and control an organization with regard to quality (ISO,CLSI)
ALL aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system
10
•Data & Laboratory Management•Safety•Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Testing
Record Keeping
Reporting
Personnel CompetencyTest Evaluations
11
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase
Path of Workflow
12
Why is the path of workflow essential to consider in health
laboratories?
13
The entire process of managing a sample must be considered:• The beginning: sample collection• The end: reporting and saving of
results• All processes in between
Laboratory tests are influenced by:laboratory environment
knowledgeable & competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping 14
Twelve Quality System Essentials
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities &
Safety
15
Organization
ResponsibilitiesAuthorities
Communication
Provision
of Resources
Quality Policy
16
human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education
Personnel
17
safe working environment
transport management
containment
security
waste managementlaboratory safety
ergonomics
Facilities and Safety
18
acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records
Equipment
19
vendor qualifications
supplies and reagents
critical services
contract review
inventory management
Purchasing and Inventory
20
quality control
sample management
method validation
method verification
Process Control
21
confidentiality
requisitions
logs and records
reports
Information Management
computerized laboratory information systems (LIS)
22
creation
revisions and review
control and distribution
Documents Records
collection
review
storage
retention
23
complaints
mistakes and problems
documentation
root cause analysis
immediate actionscorrective actions
preventive actions
Occurrence Management
24
INTERNAL
Quality Indicators
Audit Program
Laboratory Assessment
EXTERNAL
Proficiency Testing (EQA)
Inspections
AccreditationsAudit Review
25
opportunities for improvement (OFIs)
stakeholder feedback
risk assessment
problem resolution
preventive actionscorrective actions
Process Improvement
26
customer group identification
customer feedback
customer needs
Customer Service
27
ImplementingQuality Management
does notguarantee
an
ERROR-FREELaboratory
28
But it detects errors that may occur and prevents them from recurring.
29
Organization
Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Managemen
t
Assessment
Process Improvement
Customer Service
Facilities &
Safety
Laboratories notimplementing a
quality managementsystem guarantees
UNDETECTED ERRORS
30
Coordinated activities to direct and control an organization
with regard to quality.
---ISO 9000:2000
31
Laboratory Quality Management System
Innovators of Quality
Walter Shewhart1891-1967
W. Edwards Deming
1900-1993
Joseph Juran 1904-2008 (103 years) Philip Crosby
1926-2001
Robert Galvinb. 1922
32
Brief History of Quality Management
Innovator Date Cycle Walter A.Shewhart 1920s Statistical Process
Control
W. Edwards Deming 1940s Continual Improvement
Joseph M. Juran 1950s Quality Toolbox
Philip B. Crosby 1970s Quality by Requirement
Robert W. Galvin 1980s Micro Scale Error Reduction
33
Standards Organizations
ISO International Organization
for Standardization
CLSI Clinical and Laboratory
Standards Institute(formerly known as NCCLS)
Guidance for quality in manufacturing and service
industries
Standards, guidelines, and best practices for quality in medical laboratory testing
Broad applicability; used by many kinds of
organizations
Detailed; applies specifically to medical
laboratories
Uses consensus process in developing standards
Uses consensus process in developing standards
34
ISO Documents - Laboratory
ISO 9001:2000 Quality Management System Requirements Model for QA in design, development production, installation, and servicing
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 15189:2007 Quality management in the clinical laboratory
35
CLSI Quality Documents
HS1-A2 A Quality Management System Model for Health Caredescribes quality system model, 12 essentialsaligns to ISO 15189 and parallels ISO 9000 applies to all health care systems
GP26-A3 Application of Quality Management System Model for Laboratory Servicesdescribes laboratory application of quality system modelrelates the path of workflow to the quality system essentials assists laboratory in improving processesrelates to HS1-A2 and ISO 15189
36
ORGANIZATION
37
Learning Objectivesdescribe organizational elements
needed for a quality management system
discuss management roles and responsibilities in a quality system
explain the process for implementing, maintaining, and improving the laboratory quality management system
Implementation
Planning Process
Monitoring: Maintenance
and Improvement
Leadership, Managerial Roles
Organizational Structure
39
Leadership
exercising responsible authority, while providing motivation and visioninfluencing and encouraging staff to good performance
Organizational Structure
establish a working structure thatensures sufficiency at all parts in thelaboratory work flow
designate responsibilities and roles; develop an organization chart
designate a Quality Manager
allocate sufficient resources41
LABORATORY DIRECTOR
CHARGETECHNOLOGIST
ASSISTANT CHARGE
TECHNOLOGIST TECHNOLOGIST
QUALITY MANAGER
NURSING DIRECTOR
NURSING
HOSPITAL DIRECTOR
42
Quality Manager
ISO 15189 requirement
has responsibility and authority to oversee compliance
reports directly to the decision-making level of laboratory management
Quality Manager Responsibilities
monitor quality management system
assure compliance
review all records
conduct, coordinate audits
investigate deficiencies
Planning for Quality Management System
approaches vary with local situation
many factors influencestarting point
include all quality elements in plan
may implement in stepwise process
Keep in mind
communicate, be transparent
set feasible timelines
develop realistic, measurable objectives
set priorities, proceed stepwise
determine the gaps, using quality management systems checklist
develop a task list
prioritize by:– quick fixes first
– determine what
would have the
greatest positive impact
— GAP ANALYSIS —
Conduct Gap Analysis
Gap Analysis: Common Problems Identified
test ordering
sample managementtraining level (competence)of technical staffquality control
analytical process
recording and reporting results
Quality Manual
a document describing the quality management system of an organization
essential organizational step
management responsibility
49
Quality Manual
communicates information
serves as a framework for meeting quality system requirements
demonstrates management’s commitment to quality
Maintaining the Quality Manual
communicates quality policy
needs management approval
requires updating
Successful Implementation Requires
having management commitment
understanding the benefits of a quality management system
engaging staff at all levels
striving to continually improve
having realistic expectations
52
Quality
Manual
Intent to Action
53
Intent to Action
assign responsibility for implementation
allocate resources
develop and distribute a quality manualimplement quality system
monitor compliance with quality management system requirements
54
• Quality is not a science, it’s a way of thinking.
• Spend time today to gain rewards tomorrow:–quality results–efficiency–professional, personal
satisfaction–peer recognition
Remember:
55
FACILITIES AND
SAFETY
56
Learning Objectivesrelate how facility design impacts the
efficiency and safety of laboratory workers
describe practices to prevent or reduce risks
describe steps to take in response to emergencies
list personal protective equipment (PPE) that should be used routinely
Effects of Laboratory Accident
loss of staff confidence
loss of reputation
loss of customers
increased cost --- litigation, insurance
Negligence of laboratory safety is
costly!58
Everyone
is responsible for quality and safety 59
All diagnostic and health care laboratories must be designed
and organized for
Biosafety level 2 or above
60
Laboratory Designpath followed by the sample
• reception and registration of patients• sampling rooms• dispatch between different
laboratories• analysis of samples
report delivery, filing
service rooms61
Blood clotting
Hematology
Biochemistry
Washroo
m
Bacteriology
Gynaecological samples
Blood samples
Common room, stairs
to offices
Disinfection
Laboratory Design 62
Registration Desk
63
Safety During Service
no unauthorized personsno friendsno childrenno animals
64
Sample Collection Room
65
Blood clotting
Hematology
Biochemistry
Washroo
m
Bacteriology
Gynaecological samplescollection
Blood samples
collection
Common room, stairs to offices
Disinfection
Patient
Reception
ENTRANCE 66
Blood clotting
Hematology
Biochemistry
Washroo
m
Bacteriology
Gynaecological samplescollection
Blood samples
collection
Common room, stairs
to offices
Disinfection
SampleReception
ENTRANCE
67
Main Door
Doors and Large Equipment
68
Blood clotting
Hematology
Biochemistry
Washroom
Bacteriology
Gynaecological samples collection
Blood samples collection
Common room, stairs to offices
Disinfection
Waste
Reception
69
Premiseshigh ceiling with good ventilation
use washable, glossy painteasy to clean and disinfect
walls and ceiling
floor
easy to clean and disinfect 70
Benchtopsnon-porous covering, easy to clean, resistant to chemicals and disinfectant
no wood, no steel
71
Scheduled Cleaningdaily
• bench tops• floors
weekly
• ceilings, walls
others
• refrigerators, freezers, storage areas72
General Safety Equipment
shower
eye washer fire safety PPE
waste disposal73
Standard Safety Practices
75
Standard Safety Practices
DO
76
Safety Signs
77
Laboratory Hazards
physical
chemical
biological
78
needles,
syringes
broken glass, sharps
Aspiration
through pipettes
Spills, sprays
Bites, scratches animal or parasites Accidents,
injuries
79
Physical Hazards
80
do not recap needles
always use puncture-resistant, leakproof, sharps containers
always use specific waste disposal containers
never directly handle broken glass
81
82
Do you see anything wrong?
83
Do NOT reuse disposable injection equipment
84
separate cabinets for storage
spill containment cabinet
hazardous waste storage
Chemical Hazards
flammable liquids storage
85
Material Safety Data Sheet
86
aerosols and droplets
Biological Hazards
ocular invasion
inhalation
ingestion
skin penetration
87
Laboratory Fire Safety
88
PERSONNEL
89
Laboratory Staff
laboratory’s greatest asset
critical to quality
partners in public health
qualified professionals
90
Personnel Management
Job Descriptions
Orientation
Training
Competency Assessment
Continuing Education
Performance Appraisal
91
praise
recognition
bonuses
benefits
flexible time
Motivated employees are more committed to their work
92
Job Descriptions
“Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.”
ISO 15189:2007
93
Orientation
Competency Assessment
Task-specific Training
Competency Recognition
Job Description
Qualified New Employee
Retraining
94
Orientation
95
• Direct Observationchecklists
• Indirect Observations– monitoring records– re-testing– case studies
Technologist Name Technologist Title
Procedure for Evaluation
Evaluation Date Evaluator
Procedure item Accept Partial No Comment
Read procedure manual
Equipment set up appropriately
Work area neat
Reagent preparation
Perform task accurately
Perform task timely
Other: Specify
Competency Assessment Methods
96
• use standard forms • date and keep
confidential
Competency assessment documentation
Training
Continuing Education98
99
Performance Appraisal
Performance Appraisal
Competency Assessmen
CONFIDENTIAL
John Smith
Training Records
Competency Assessment
Personnel Records
100
EQUIPMENT
101
Performance high level
Test resultsVariation/ Time
Lowers repair costs Lengthens
lifespan
Equipment Management Benefits
102
Reduces interruption of services
Increases safety
Greater customer
satisfaction
Equipment Management Benefits
103
Selecting and Acquiring Equipment
easy to use
language
warranty
safety
will it fit?
104
Negotiating Equipment Acquisition
wiring diagrams
software information
parts list
operator manual
installation by manufacturer
trial period105
Before Equipment Installation
confirm vendor’s responsibilities in writing
establish checklist
106
Equipment Installation
when possible, have manufacturer install and set up
do not attempt to use prior to proper installation
verify package contents
copy software, if part of system
107
After Equipment InstallationInventory
Record
Calibration Verification Operating
Procedures
Maintenance Program
Train ALL Operators108
• perform initial calibration– use calibrators or
standards– follow
manufacturer’s instructions
• determine frequency of routine calibrations
Equipment Calibration
109
Performance Evaluation
Test known samples, analyze data
Establish stability for temperature- controlled equipment
Validate performance with parallel samples
NEW EQUIPMENT
110
Preventive Maintenance
routine cleaning
adjustment, replacement of equipment parts
111
Function Checks
Monitor instrument parameters:
– periodically, daily, weekly, monthly
– after major instrument repair
Examples:– incubator temperatures– wavelength calibration– autoclave temperature chart
112
Create an Equipment Inventory Log
instrument type, model number, serial numberlocation in laboratorydate purchased
manufacturer and vendor contact info
warranty, spare parts
113
TroubleshootingWhat is the source of the problem?
• Sample?• Reagent?• Water,
Electricity?• Equipment?
114
When in-house efforts fail:
• call manufacturer orother technical expert
• look for options to continue service obtain back-up instrument
from central stores or manufacturer
refer sample to nearby laboratory 115
Do NOT use equipment that does not function properly
WARNING OUT OF ORDER
DO NOT USE
• manufacturerslaboratory must schedule routine
manufacturer’s maintenancewarranty may require repair handled by
manufacturer
• in-house biomedical service technicians
Service and Repair
Recording Problems
date problem occurred, equipment removed from service
reason for breakdown or failure
corrective actions taken
date returned to use
change in maintenance or in function checks
118
Example of logbook 1
119
Example of logbook 2
120
Example of logbook 3
121
PURCHASING AND INVENTORY
122
Benefits of an Inventory Management Program
Quality Maintained
Minimize waste
Stay within budget
Supplies and reagents always available
123
Inventory Management Challenges
balance between stock availability and expiration dates
life-span of laboratory reagents varies
In-stock
Expiry
Date
124
Establish a System to Qualify and Select
Vendorsdefine criteria for supplies and services to be purchased
use information from other laboratories
evaluate before purchase and after receipt
125
Determine payment
mechanisms
Negotiate prices
Review Contracts
Understand government
requirements
Assure reliable
availability, delivery
Purchasing Considerations
126
INVENTORY
CONTROL
Assign
responsibility
Analyze
needs
Establish
minimum stock
needsDevelop
forms and logs
Establish
system for
receiving, storing
Maintain
inventory system
in all storage
areas
How to Implement Inventory Control
127
Analyze Needs
listing all tests in the laboratory
identifying all supplies needed for each test
using available information to estimate usage
128
Item Description
Unit of
count
Usage/
month (quantification)
Priority
Level
Order lead
time/
delivery
time
Storage
space,
conditions
Information Required for Analysis of Needs
129
Quantification: How?
consumption-based method
morbidity-based method
130
Quantification: Consumption-Based
based on actual usage
must take into account:• health-supplies actually used• waste: expired or spoiled supplies• supplies out of stock for more
than 15 days during any time of year 131
Quantification: Consumption-Based
0102030405060708090
1stQtr
2ndQtr
3rdQtr
4thQtr
Slides
Immersion Oil
Collectioncontainers
132
Quantification: Morbidity-Based
based on actual number of episodes
must take into account:• population size• disease incidence• accuracy of morbidity data• treatment guidelines
133
Quantification: Morbidity-Based
0
20
40
60
80
100
120
140
160
180
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
Influenza
Diarrhea
TB
134
Inventory Control: Documentation
Maintain records: date received lot number pass or fail acceptance criteria date placed in service or disposition
May be useful to keep records in stockroom.
Stock Logbook
Includes: name and
signature date of receipt quantity date of expiry minimum stock stock balance
Other information:– shelf number– destination 136
inspect new orders at time of delivery• verify contents
• check integrity
• record date each item received
• record expiration date
• store new shipment behind existing shipment
• create or update records
137
Use clearly visible dating labels
date opened
date expired
138
Continuous Monitoring of Inventory
Inventory Control
Assign responsibility
Maintain inventory system
in all storage areas
Conduct weekly physical counts
Update records
139
Computerized Stock Management
advantages
• exact current state of stock• management of expiration dates• makes inventory tasks easier
drawbacks
• on-site computer is needed• requires trained staff 140
PROCESS CONTROL
141
The result of any laboratory examination is only as good as the sample received in the laboratory.
142
143
Components
LaboratoryHandbookPolicies & Practices
144
• contains information needed by those who collect samples
• available to all sample collection areas
• must be understood by all laboratory staff
• referenced in the quality manual
Laboratory Handbook
145
Laboratory Handbook
name and address of laboratory contact names and telephone
numbers hours of operation list of tests that can be ordered sample collection procedures sample transport procedures expected turn around times (TAT) how urgent requests are handled 146
Define a good labeling systemAssess all samples -
preexamination
Provide sample collection information
What- When- How
Provide appropriate containers and supplies
The Laboratory’s Responsibilities
• patient ID
• tests requested
• time and date of sample collection
• source of sample, when appropriate
• clinical data, where indicated
• contact information of requesting physician
Test Requisition
148
• patient preparation• patient identification• type of sample
required• type of container
needed• labeling• special handling• safety precautions
Collection Requirements
149
Labeling
patient’s name
patient’s unique ID numbertest ordered
time and date of collection
collector’s initials
150
Outcomes of Improper Collection
delays in reporting test results
unnecessary re-draws/re-tests
decreased customer satisfaction
increased costs
incorrect diagnosis / treatment
injury and death151
Preexamination Steps• Verify
–completeness of test request
–appropriateness of sample
–information on label
• Record in register or log
• Enforce sample rejection criteria 152
Labeled samples, completed requisitions
Spilled urine sample, a cause for rejection
153
Actions for Rejected Samples
inform authorized person
request another sample
record rejected samples
retain rejected sample based on preset criteria
extraordinary circumstances may require testing suboptimal samples
154
Sample Register or Log
date and time of collectiondate and time of receiptsample typepatient namedemographics as requiredlaboratory assigned
identificationtests to be performed
155
Sample Handling
Handle all samples as if infectious
156
Sample Disposal
• set policy for sample disposal• compliance with local and country
regulations • disinfection procedures
157
Sample Transport
Maintain integrity of sample– temperature– preservation of sample– special transport containers– time limitations
Assure safety regulationsare met
158
Classification of Infectious Substances
New Classification in 2005: based on two transport categories
Category A: infectious substances capable of causing • permanent disability
• life-threatening or fatal disease to humans or both human and animals
Packaging: most durable triple packaging with full dangerous goods documentation
Training of transport staff
159
Category B: infectious substances not included in Category A
less stringent triple packaging
no dangerous goods documentation required
Classification of Infectious Substances
160
Category A
161
Quality Control (QC) is part of quality management focused on fulfilling quality requirements ISO 9000:2000 (3.4.10)
QC is examining “control” materials of known substances along with patient samples to monitor the accuracy and precision of the complete examination (analytic) process.
162
The goal of QC is to detect errors and correct them before patients’ results are reported.
163
Quantitative Examinations
Measure the quantity of a particular substance in a sample.
Measurements should be both accurate and precise
164
Qualitative ExaminationsExaminations that do not have
numerical results
growth or no growthpositive or negativereactive or non-reactive color change
165
Semi-Qualitative Examinations
Results are expressed as an estimate of the measured substance
“trace amount”, “moderate amount,” or “1+, 2+, or 3+” number of cells per microscopic field titers and dilutions in serologic tests
166
QC Progra
m Steps
Establish written
policies and procedures
Train all staff
Assure complete
documentation
Review
QC data
include corrective actions
167
What is a Control?
material that contains the substance being analyzed
used to validate reliability of the test system
include with patient samples when performing a test
run after calibrating the instrumentrun periodically during testing
168
Calibrators vs. Controls
169
Calibrators
A substance with a specificconcentration. Calibrators are used to set(calibrate) the measuring points on a scale.
1 2 3 4 5
Controls
A substance similar to patients’ samples that has an establishedconcentration.
Controls are used to ensurethe procedure is working properly.
1 2 3 4 5
170
Characteristics of Control Materials
appropriate for the diagnostic sample
values cover medical decision points
similar to test sample (matrix)
available in large quantity; ideally enough for one year
can store in small aliquots
171
Types of Control Materials
may be frozen, freeze-dried, or
chemically preserved
requires very accurate
reconstitution if this step is necessary
172
Sources of Controls Materials
commercially prepared
made “in house”
obtained from another laboratory, usually central or reference
laboratory
173
Control Materials
ASSAYEDTarget value predeterminedVerify and use
UNASSAYEDTarget value not predeterminedFull assay required before using
“IN-HOUSE”In-house pooled seraFull assay, validation
174
Choosing Control Materials• values cover medical decision points
• similar to the test sample• controls are usually available in high,
normal, and low ranges
175
Steps in Implementing Quantitative QC
obtain control materialrun each control 20 times over 30 days
Mean
1SD
1SD
2SD
3SD
2SD
3SD
calculate mean and +/-1,2,3 Standard Deviations
176
Measurement of Variability
Variability is a normal occurrence when a control is tested repeatedly
Operatortechnique
Environmental
conditions
Performance
characteristics of
the measurement
The goal is to differentiate between variability due to chance from that due to error
177
Measures of Central Tendency Although variable, sets of data are
distributed around a central value
Frequency
Measurement178
Measures of Central Tendency
Mode the value which occurs with the greatest frequency
Median the value at the center or midpoint of the observations
Mean the calculated average of the values
179
Not all central values are the same.
Frequency
Measurement
Mean Mode
Median
180
Symbols Used in Calculations
∑ is the sum of (add data points)
n = number of data points
x1 - xn = all of the measurements (1 through n)
__ X represents the mean
181
Quality Control is used to monitor the accuracy and the precision of
the assay.
What are accuracy
and precision?
182
Accuracy
The closeness of measurements to the true value
Precision
The amount of variation in the measurements
Bias
The difference between the expectation of a test result and an accepted reference value
183
Accuracy and Precision
Accurate and Precise
Precisebut Biased Imprecise
Accurate = Precise but not Biased184
Standard Deviation and Probability
68.2%
95.5%
99.7%F
req
uen
cy-3s - 2s -1s Mean +1s
+2s +3s
XFor a set of data with a normal distribution, a random measurement will fall within:
+ 1 SD 68.3% of the time
+ 2 SD 95.5% of the time
+ 3 SD 99.7% of the time
185
Levey-Jennings Chart
Graphically Representing Control Ranges
186
Statistics for Quantitative QC
assay control material at least 20 data points over a 20-30 day period
ensure procedural variation is represented
calculate mean and + 1, 2 and 3 SD
187
MEAN+1SD
+2SD
-1SD
-2SD
-3SD
+3SD
Days
190.5
192.5
194.5
196.5
188.5
186.5
184.6
Chart name: Lot number:
Draw lines for Mean and SDs(calculated from 20 controls)
188
Number of Controls
Interpretation depends on number of controls run with patients’
samples.
Good: If one control: accept results if control is within ± 2SDunless shift or trend
Better: If 2 levels of controls apply Westgard multirule system
189
Detecting Error• random error: variation in QC results
with no pattern- only a cause for rejection if outside 2SDs.
• systematic error: not acceptable, correct the source of errorExamples:– shift–control on one side of the mean 6
consecutive days– trend–control moving in one direction–
heading toward an “out of control” value
190
MEAN+1SD
+2SD
-1SD
-2SD
-3SD
+3SD
Days
190.5
192.5
194.5
196.5
188.5
186.5
184.6
Levey-Jennings Chart Shift
191
MEAN+1SD
+2SD
-1SD
-2SD
-3SD
+3SD
Days
190.5
192.5
194.5
196.5
188.5
186.5
184.6
Levey-Jennings Chart Trend
192
If QC is out of control
• STOP testing• identify and correct problem• repeat testing on patient
samples and controls after correction
• Do not report patient results until problem is solved and controls indicate proper performance
193
Solving out-of-control problems
identify problem
refer to established policies and procedures for remedial action
194
Possible Problems
• degradation of reagents or kits• control material degradation• operator error• failure to follow manufacturer’s
instructions• an outdated procedure manual• equipment failure• calibration error
195
Qualitative or Semi-quantitative tests
• microscopic examinations • dipsticks • serologic procedures • microbiological procedures • any reaction that produces non-
numeric results
196
Quality Control Materials
built-in controls
control materials that mimic patient samples
reference organisms
197
Built-in Controls
integrated into the design of a test kit device
automatically run with each test performed
assess certain aspects of kit performance
may not assess entire testing process 198
Stock Cultures for QC
reference strains
in-house developed strains
predictable reactions in stains and media
ensure media, reagents and supplies work as intended
199
Sources for Obtaining Reference Strains
ATCC-American Type Culture Collection
CIP- Pasteur Institute Collection (France)
NTCC-National Type Culture Collection (UK)
200
Stain Management
use established procedure for preparation or reconstitution
store appropriately
label: content, concentration, date prepared and placed in service, expiration, initials
201
Quality Control for Stains
check with known organisms or cells
examine for contaminants such as bacteria and fungi
examine for crystal shards or for precipitation
Left: Wright stain
Right: Gram stain
202
QC of Microbiology Media
verify performance of all media
commercially prepared: new lot only
in-house prepared: all batches
MacConkey Agar
QC
Left: non-lactose fermenter
Right: lactose fermenter
203
Media Problems to Avoid
out-dated dried-out contaminated
Human blood should not be used because: too much batch to batch variationmay include inhibitory substances, including antimicrobialsmay contain biohazards (e.g., hepatitis virus)
204
DOCUMENTS AND RECORDS
205
Documents communicate
information via policies, processes, and procedures
need updating
Records capture information
on worksheets, forms, labels, and charts
permanent, do not change
RECORDS
Documents and Records—How do they differ?
206
Why do laboratories need to manage documents and records?
To find information whenever it is needed!
207
Information is the major product
of the laboratory.
208
Laboratory Documents
Policies
ProcessesProcedures
209
Policies - The “WHAT TO DO” A written statement of overall intentions and directions defined by those in the organization and endorsed by management.” (CLSI HS1-A3)
Processes - The “HOW IT HAPPENS”
A “set of interrelated or interacting activities that transform inputs into outputs.” (ISO 9000 4.3.1)
Procedures - The “HOW TO DO IT”
Standard operating procedures (SOP)210
Hierarchy of Documents
“How to do it”
“How it happens”
“What to do”
211
Documents are the communicators of the quality management system
Verbal instructions often are:
• not heard• misunderstood• quickly forgotten• difficult to follow
212
Why are documents important?
• essential guidelines for laboratory
• quality manual• SOPs• reference materials
• required by formal laboratory standards 213
Documents are a reflection of the laboratory’s organization and its quality management.
A good rule to follow is:
“Do what you wrote and write what you are doing.”
214
Good Documents are:
• clear
• concise
• user-friendly
• explicit
• accurate
• up-to-date
215
Documents for work processes should be accessible to staff at the work site
• instructions on handling incoming samples• SOPs for each test• quality control charts
and trouble-shooting instructions
• safety manuals and precautions
216
Standard Operating Procedures (SOPs) are documents that:
describe how to perform a test using step-by-step instructions
written SOPs help ensure:–consistency–accuracy–quality
217
A Good SOP
• provides detailed, clear, and concise direction for testing techniques
• is easily understood by new personnel
• is reviewed and approved by management
• is updated on a regular basis218
Standardized SOP Format
• Computerized procedure• Standardization:
– Header– Version/chapter/
reference– Author/reader/validator– Recipients– Version date/Application
date– Typical outline
• Updating and storage of different versions is easy
Complete Standardized Header
Use at the top of the first page only
220
Reduced Standardized Header
• other pages of every procedure
• use at the top of all other pages
221
determineprocedure
to use
assess scientific validity
include each step
gather all documents
establish means for
updating
When Preparing SOPs
Suggested Outline for SOPs
• Title: Name of Test• Purpose: Medical use• Instructions:
– Preexamination – Examination– Postexamination
• References to verify the method is established
• Author’s name• Approval signature(s)–initial and date
223
Do not rely solely on manufacturer product inserts
Inserts do not provide specific information for test sites, such as:
• materials required, but not in kit
• specific safety requirements
• external quality control requirements
224
Job Aids
• shortened version of SOPs• hand written or printed • visible location at testing site• useful tool to assure all testing steps
are correctly performed
225
Job Aids
226
Document Controlassures that the
most current version is used
ensures availability when needed
Preparation
Review
Issue Distribution
Revision Approval
Document Preparation and Control Process
228
Common Document Control Problems
• outdated documents• too many documents are
distributed and the systemcannot be maintained
• lack of control of documentsof external and internal origin
229
Laboratory Records
Sample log book
or register
WorkbooksWorksheets
Instrument printouts
Maintenance records
Quality control
data
EQA / PT
records
Patient test
reports
230
More Records
Personnel records
Internal audits results
External audits results
Continuous improvement
User surveys
Customer feedback
Critical communications
231
Test Report Contents ISO 15189
• test identification• laboratory
identification• patient unique
identification and location
• name and address of requestor
• date and time of collection
• time of receipt in lab• date and time of
release of report
• primary sample type• results (SI units)• biological reference
intervals• interpretive
comments• person authorizing
release, with signature when possible
• note if reporting a corrected result
INFORMATION MANAGEMENT
233
Quality Lab Report
The test result is the final product of the laboratory.
234
Paper-based
Electronic
Establish processes for managing data
Patient information
accessible accurate timely secure confidential private
Quality Lab Report
ID 0905120047
Information Management
235
Effective communication
Effective communication
Effective reporting systems
Effective reporting systems
ConfidentialConfidentialData
protectionData
protection
Checking processesChecking processes
Logs, worksheets
Logs, worksheets
Standardized request forms
Standardized request forms
Unique identifierssamples, patients
Unique identifierssamples, patients
Important elements
236
Protect Confidentiality
safeguard a patient’s privacy
assure laboratory data confidentiality
237
Data Protection
Paper-based systems• use durable materials for
recording
• store records properly
Computerized systems• schedule regular backup of data
238
Computer systems
incompatible
Computer systems
incompatible
Transmission errors
Transmission errors
Data organized
poorly
Data organized
poorly
Archivingpoor
Archivingpoor
Forms inadequate
Forms inadequate
IDinsufficient
IDinsufficient
Data incomplete
Data incomplete
Common Problems
239
Integrate with other
sites
Integrate with other
sites
Financial managementFinancial
management
Access control
Access control
Track,analyze trends
Track,analyze trends
Track reportsTrack
reports
Detailed, legible reports
Detailed, legible reports
Data retrievaloptions
Data retrievaloptions
QC QC
Error reductionError
reduction
240
Back-up requirements
Back-up requirements
Costs:purchase
and maintenance
Costs:purchase
and maintenance
Adapting to a new system
Adapting to a new system
Training:time
and money
Training:time
and money
241
OCCURRENCE MANAGEMENT
242
What is an occurrence?Any event that has a negative impact
on an organization, includes personnel, product, equipment, or the environment.
243
Some Common Laboratory Occurrences
• proficiency testing error
• no action on out of range controls
• false negative result
• late reports
• missing reports
• complaints
• laboratory accident 244
equipment not properly maintained
equipment not properly maintained
QC, EQA not
performed
QC, EQA not
performed
test kits not stored
properly
test kits not stored
properlytranscription
errors checks
not done
transcription errors checks
not done
training not done
or not completed
training not done
or not completed
written procedures not followed
written procedures not followed
no written proceduresno written
procedures
individual responsibilities
unclear
individual responsibilities
unclear
Common CAUSES of Error
245
THE PATIENT Test selection Sample Collection
Sample Transport
Laboratory Analysis Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase
Errors can occur throughout the testing process
246
wrong sample collected
Preexamination Errors
sample mislabeled or unlabeled
sample transported inappropriately
reagents or test kits damaged by improperstorage
247
incorrect timing of test
Examination Errors
results reported when control results out of range
improper dilution and pipetting of sample or
reagents
reagents stored inappropriately
248
transcription error in reporting
Postexamination Errors
report illegible
report sent to the wrong location
report not sent
249
Communicate
ACTION
Awareness
Investigate
The Occurrence Cycle
250
AccreditationCertification
Seeking OFIs
Quality indicators
External audits
PT / EQA
Internal audits
Monitoring complaints
Customer satisfaction
Management Review
How are occurrences detected?
251
EVENTSee the potential event and plan to avoid it
Preventiveactions
Address the eventand its consequences
Remedial actions
Correctiveactions
Learn from the eventand avoid its recurrence
Occurrence Management
252
ASSESSMENTS
254
Why perform an assessment?
• learn “where we are” in terms of quality management
• measure gaps• need information for:
planning and implementationmonitoring continuous improvement
255
Important Skills
for Auditors
Attention
to detail
Trained
Diplomatic
Technical/ Quality
management expertise
Communicate effectively
256
Continuous monitoring is
the key element to success in the Quality System
257
“It isn’t what you find…
it’s what you doabout what you
find.”
-Philip Crosby258
EQA Methods
ProficiencyTesting
Rechecking
Retesting
On-siteEvaluation
259
External Quality Assessment (EQA)
comparison among different test sites early warning for systemic problems objective evidence of testing quality areas that need improvement training needs 260
External Quality Assessment (EQA)
• important for improvement• a measure of laboratory
performance
261
Proficiency Testing
ISO/IEC Guide 43-1:1997
“Proficiency testing schemes (PTS) are interlaboratory comparisons that are organized regularly to assess the performance of analytical laboratories and the competence of the analytical
personnel.” 263
PT organization /provider
Laboratory
Analyze
Evaluation
PT performance report
Returnresults
PT samples sent regularly
ReceivePT report
Corrective Actions
Proficiency Testing
264
Laboratory 1 Laboratory 2
No discussion between labs
Final PT report received
ISO 15189
Analyze same manner with same personnel
Improvement
PT sample
Patient sample
265
Information received from PT participation must be directed toward improvement in the laboratory to receive the full value.
266
PT Limitations
PT results are affected by variables not related to patient samples
PT will not detect all problems in the laboratory
PT may not detect problems with pre- and post examination procedures
267
Retesting
tested by reference laboratory performed on dried blood spots or
serum not blinded statistically significant primarily used to assess HIV rapid
testing
268
EQA
Identifyproblems
TakeCorrective
Action
EQA Should Lead to Actions
271
Standardization Bodies
ISO
CLSI
CEN
WHO 272
International Organization for Standardization
world's largest developer and publisher of international standards
standards are applicable to many kinds of organizations including clinical and public health laboratories
273
Clinical and Laboratory Standards Institute
global, nonprofit, standards-developing organization
promotes the development and use of voluntary consensus standards and guidelines within the health care community 274
European Committee for Standardization
national standards bodies in the European Economic Community and associated countries
general terms include openness and transparency, consensus, and integration
275
World Health Organization
has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles
276
Elements of an Accreditation Process
Accreditation BodyStandards
Assessors
User laboratory
278
Certification and
Accreditation Bodies
Competent staff
Objective
Standards-based
KnowledgeableApproved
279
Laboratory
Opening today!
Licensure
Laboratory
Certification
ISO 9001
Quality Manual
SOPs
ReferenceLaboratory
ISO 15189WHO POLIO
ISO 9001
Quality Manual
SOPs
Accreditation
Where is your Laboratory?
280
not one to be taken lightly or without forethought
Requirements
knowledge resources
commitment planning
Process for Accreditation
281
Accreditation does not guarantee success, it is only one step along the quality journey
CONTINUALIMPROVEMENT
QUALITYMANAGEMENT
CUSTOMERSATISFACTION
ACCREDITATION
ERRORREDUCTION
282
Accredited laboratories tend to:
perform better on proficiency testing
are more likely to have a working quality management
system283
2008
MAINTAINED
2009
MAINTAINED
2010
MAINTAINED
2007
PRIMARY
It is an ACHIEVEMENT
to maintain accreditation
284
It is an accomplishmentto receive accreditation
2007
PRIMARY
285
COSTUMER SERVICE
286
Quality is meeting customer needs.
Philip CrosbyFour Absolutes of Quality
Management 1979
287
Who is responsible for Customer Service?
Everyone in the
laboratory!
288
Program for Improving Customer Satisfaction
Requires:• commitment from all staff• planning• knowledge of monitoring tools• resources
289
Community
Patients
Public Health
Laboratory
PhysiciansHealth care
provider
The Laboratory and Its Clients
290
Customer service is an integral part of a quality management
system
Good customer service provides:
• valuable information for best patient care
• valuable information to improve surveillance
• professional image of laboratory
293
interviews, focus groups
satisfaction surveys
management review
internal audit
qualityindicators
complaint monitoring
MONITOR
Methods for Assessing Customer Satisfaction
294
Complaints
Actual dissatisfied customers!
295
Monitoring quality indicators
Conducting internal audits
Reviewing by management
ACTION
Assessment Methods
296
analyzed in a timely
manner
analyzed in a timely
manner
no leading questions, unbiased
no leading questions, unbiased
pre-testedpre-tested
organizedorganized
plannedplanned
Successful surveys
Customer Surveys
297
An active Quality Management Systemensures Laboratories Meet
ALL Client Requirements
298
PROCESS IMPROVEMENT
299
W. Edwards Deming14 Points for Quality
Two points address continual improvement:
• create constancy of purpose for improvement
• improve constantly and forever
300
Act
Plan
Do
Check
The Deming Cycle
301
Continual Improvement(ISO 15189:2007)
develop plan for
improvementidentify potential sources of error
implement
review the effectiveness
of action
adjust the action plan
and modify the
system
302
Optimizing space, time, and activity to improve the physical paths of workflow.
Lean
New Trends-Improvement Tools
303
Organized processes to assist in decision making for continual improvement:
control define measure analyze improve
Structure in Six Sigma
304
Quality Indicators
• indicate performance
• determine quality
• highlight concerns
• identify areas needing further study
• track changes over time
305
Use an indicator only as long as it provides
useful information.
Don’t get tied to your indicators.
Quality Indicators and Timing
306
Use an indicator only as long as it provides
useful information.
Don’t get tied to your indicators.
Quality Indicators and Timing
307
References
308
Thank you!309