1. 1

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
2

3. 3

4. Essential to all aspects of health care
are laboratory results that are:
accurate
reliable
timely
4

5. Achieving a level of quality
means
accepting a 1% error rate
5

6. In France a error rate
would mean everyday
14 minutes without water or electricity
50,000 parcels lost by postal services
22 newborns falling from midwives’ hands
600,000 lunches contaminated by bacteria
3 bad landings at Orly Paris airport
6

7. Result of
error
7

8. time
personnel
effort
patient
outcomes
8

9. unnecessary treatment; treatment
complications
failure to provide the proper treatment
delay in correct diagnosis
additional and unnecessary diagnostic
testing
9

10. 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

11. Reporting Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
•Data & Laboratory
Management
•Safety
•Customer Service
Sample Receipt and
Accessioning
Record Keeping
Sample Transport
Quality Control
Testing
11

12. THE PATIENT Test selection Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport Report Creation
Result Interpretation Postexamination Phase
12

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
13

14. Laboratory tests are influenced by:
laboratory environment
knowledgeable & competent staff
reagents and equipment
quality control
communications
process management
occurrence management
record keeping 14

15. Organization Personnel Equipment
Purchasing Process Information
& Control Management
Inventory
Documents
& Occurrence Assessment
Records Management
Facilities
Process Customer
&
Improvement Service
Safety
15

16. Responsibilities
Authorities
Quality
Policy
Provision
Communication
of
Resources
16

17. human resources
job qualifications
job descriptions
orientation
training
competency assessment
professional development
continuing education 17

18. safe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics
18

19. acquisition
installation
validation
maintenance
calibration
troubleshooting
service and repair
records 19

20. vendor qualifications
supplies and reagents
critical services
contract review
inventory management
20

21. quality control
sample management
method validation
method verification
21

22. confidentiality
requisitions
logs and records
reports
computerized laboratory
information systems (LIS)
22

23. creation collection
revisions and review
review
storage
control and
distribution retention
23

24. complaints
mistakes and problems
root cause analysis
documentation
immediate actions
corrective actions
preventive actions
24

25. INTERNAL EXTERNAL
Quality Proficiency
Indicators Testing (EQA)
Audit Program Inspections
Audit Review Accreditations
25

26. opportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions
26

27. customer group identification
customer needs
customer feedback
27

28. Implementing
Quality Management
an
Laboratory
28

29. 29

30. Organizatio Personnel Equipment
n
Purchasing Information
Process
& Management
Control
Inventory
Documents
Occurrence
& Assessment
Managemen
Records
t
Customer Facilities
Process
Service &
Improvement
Safety
30

31. 31

32. Walter W. Edwards
Shewhart Deming
1891-1967 1900-1993
Joseph Juran
Philip Crosby Robert Galvin
1904-2008 (103 years)
1926-2001 b. 1922
32

33. 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

34. ISO CLSI
International Organization Clinical and Laboratory
for Standardization Standards Institute
(formerly known as NCCLS)
Guidance for quality in Standards, guidelines, and
manufacturing and service best practices for quality in
medical laboratory testing
industries
Broad applicability; used Detailed; applies
by many kinds of specifically to medical
organizations laboratories
Uses consensus process in Uses consensus process in
developing standards developing standards
34

35. 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

36. HS1-A2 A Quality Management System Model
for Health Care
describes quality system model, 12 essentials
aligns to ISO 15189 and parallels ISO 9000
applies to all health care systems
GP26-A3 Application of Quality Management
System Model for Laboratory Services
describes laboratory application of quality system model
relates the path of workflow to the quality system essentials
assists laboratory in improving processes
relates to HS1-A2 and ISO 15189
36

37. 37

38. describe 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

39. Leadership, Managerial Roles
Organizational
Structure
Planning
Process
Implementation
Monitoring:
Maintenance
and Improvement
39

40. exercising responsible
authority, while
providing motivation
and vision
influencing and
encouraging staff
to good performance

41. establish a working structure that
ensures sufficiency at all parts in the
laboratory work flow
designate responsibilities and roles;
develop an organization chart
designate a Quality Manager
allocate sufficient resources
41

42. HOSPITAL DIRECTOR
LABORATORY
DIRECTOR NURSING
DIRECTOR
CHARGE QUALITY
TECHNOLOGIST MANAGER
ASSISTANT CHARGE
NURSING
TECHNOLOGIST TECHNOLOGIST
42

43. ISO 15189 requirement
has responsibility and authority to
oversee compliance
reports directly to the decision-making
level of laboratory management

44. monitor quality management system
assure compliance
review all records
conduct, coordinate audits
investigate deficiencies

45. approaches vary
with local situation
many factors
influence
starting point
include all quality
elements in plan
may implement in
stepwise process

46. Keep in mind
communicate, be
transparent
set feasible
timelines
develop realistic,
measurable
objectives
set priorities,
proceed stepwise

47.  determine the gaps, using
quality management
systems checklist — GAP ANALYSIS —
 develop a task list
 prioritize by:
– quick fixes first
– determine what
would have the
greatest positive impact

48. test ordering
sample management
training level (competence)
of technical staff
quality control
analytical process
recording and reporting
results

49. a document describing the quality
management system of an organization
essential
organizational step
management
responsibility
49

50. communicates information
serves as a framework for
meeting quality system
requirements
demonstrates management’s
commitment to quality

51. communicates quality policy
needs management approval
requires updating

52. having management commitment
understanding the benefits of a quality
management system
engaging staff at all levels
striving to
continually improve
having realistic
expectations
52

53. 53

54. assign responsibility for implementation
allocate resources
develop and distribute a quality manual
implement quality system
monitor compliance with quality
management system requirements
54

55. • Spend time today to
gain rewards tomorrow:
– quality results
– efficiency
– professional, personal
satisfaction
– peer recognition
55

56. 56

57. relate how facility design impacts the
efficiency and safety of laboratory
workers
describe practices to prevent or reduce
risks
list personal protective equipment (PPE)
that should be used routinely
describe steps to take in response to
emergencies

58. loss of staff confidence
loss of reputation
loss of customers
increased cost --- litigation, insurance
Negligence
of laboratory safety is
costly! 58

59. 59

60. All diagnostic
and health care
laboratories
must be designed
and organized for
Biosafety level 2
or above
60

61. path followed by the sample
• reception and registration of patients
• sampling rooms
• dispatch between different laboratories
• analysis of samples
report delivery, filing
service rooms
61

62. Common
room, stairs to
offices
Gynaecological
samples
Blood clotting
Wash
room Blood
samples
Hematology
Biochemistry
Disinfection
Bacteriology
62

63. 63

64. no unauthorized persons
no friends
no children
no animals
64

65. 65

66. Common
room, stairs to
offices
Gynaecological
samples
collection
Blood
clotting
Blood
samples
Hematology
collection
Wash
Biochemistry room
Patient
Reception
Disinfection
Bacteriology
66
ENTRANCE

67. Common
room, stairs to
offices
Gynaecological
samples
collection
Blood clotting
Blood
samples
Hematology
collection
Wash
Biochemistry
room
Sample
Reception
Disinfection
Bacteriology ENTRANCE
67

68. Main
Door
68

69. Common
room, stairs to
offices
Gynaecological
samples
Blood collection
clotting
Blood
Hematology samples
collection
Wash
Biochemistry room
Waste
Reception
Disinfection
Bacteriology
69

70. high ceiling with good ventilation
walls and ceiling
use washable, glossy paint
easy to clean and disinfect
floor
easy to clean and disinfect
70

71. non-porous covering, easy to
clean, resistant to chemicals and
disinfectant
no wood, no steel
71

72. daily
• bench tops
• floors
weekly
• ceilings, walls
others
• refrigerators, freezers, storage areas
72

73. 73

74. 74

75. 75

76. 76

77. 77

78. physical
chemical
biological
78

79. needles,
syringes
Bites,
scratches
animal or broken
parasites Accidents, glass,
sharps
injuries
Aspiration
Spills, through
sprays pipettes
79

80. 80

81. do not recap needles
always use puncture-
resistant, leakproof,
sharps containers
always use specific waste
disposal containers
never directly handle broken
glass
81

82. 82

83. Do you see anything wrong?
83

84. Do NOT reuse disposable injection equipment
84

85. separate cabinets for storage
spill containment cabinet
hazardous waste storage
flammable liquids storage
85

86. 86

87. aerosols and droplets
ocular invasion
inhalation
ingestion
skin penetration
87

88. 88

89. 89

90. laboratory’s greatest asset
critical to quality
partners in public health
qualified professionals
90

91. Job
Descriptions
Performance
Orientation
Appraisal
Personnel
Management
Continuing
Training
Education
Competency
Assessment
91

92. Motivated employees are more
committed to their work
 praise
 recognition
 bonuses
 benefits
 flexible time
92

93. “Laboratory Management shall
have job descriptions that
define qualifications and duties
for all personnel.”
ISO 15189:2007
93

94. Qualified New Employee
Job Description
Orientation Task-specific Training
Retraining
Competency Assessment
Competency Recognition
94

95. 95

96. • Direct Observation Technologist Name Technologist Title
checklists
Procedure for Evaluation Date Evaluator
Evaluation
Procedure item Accept Partial No Comment
• Indirect Observations Read procedure
manual
– monitoring records Equipment set up
appropriately
– re-testing Work area neat
– case studies Reagent preparation
Perform task
accurately
Perform task timely
Other: Specify
96

97. • use standard forms
• date and keep
confidential

98. Training
Continuing Education
98

99. competencies
adherence
professional
to policy
behavior
Performance
Appraisal
observation
punctuality to safety
customer
service communication
99

100. Training Records Performance
Appraisal
Competency
Assessment
John Smith
Competency Assessmen
CONFIDENTIAL
100

101. 101

102. Test results
Variation/
Time
Performance
high level
Lowers
Lengthens
repair costs
lifespan
102

103. Increases safety
Reduces
interruption
of services
Greater
customer
satisfaction
103

104. easy to use
language
warranty
safety
will it fit?
104

105. wiring diagrams
software information
parts list
operator manual
installation by
manufacturer
trial period
105

106. confirm vendor’s responsibilities in
writing
establish checklist
106

107. 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

108. Inventory
Record
Operating
Calibration Verification
Procedures
Maintenance Program
Train ALL Operators
108

109. • perform initial
calibration
– use calibrators or
standards
– follow
manufacturer’s
instructions
• determine frequency
of routine calibrations
109

110. Test known samples,
analyze data
Establish stability
for temperature-
controlled
equipment
NEW
Validate
EQUIPMENT performance with
parallel samples
110

111. routine cleaning
adjustment,
replacement of
equipment parts
111

112. Monitor instrument parameters:
– periodically, daily, weekly,
monthly
– after major instrument repair
Examples:
– incubator temperatures
– wavelength calibration
– autoclave temperature chart
112

113. instrument type, model number,
serial number
location in laboratory
date purchased
manufacturer and
vendor contact info
warranty, spare parts
113

114. What is the source of the
problem?
• Sample?
• Reagent?
• Water, Electricity
?
• Equipment?
114

115. When in-house efforts fail:
• call manufacturer or
other technical expert
• look for options to continue service
 obtain back-up instrument from
central
stores or manufacturer
 refer sample to nearby laboratory
115

116. Do NOT use equipment that does not
function properly
WARNING
OUT OF ORDER
DO NOT USE

117. • manufacturers
laboratory must schedule routine
manufacturer’s maintenance
warranty may require repair handled by
manufacturer
• in-house biomedical
service technicians

118. 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

119. Example of logbook 1
119

120. Example of logbook 2
120

121. Example of logbook 3
121

122. 122

123. Minimize waste
Supplies and
reagents always Stay within
available Quality budget
Maintained
123

124. balance between stock
availability
and expiration dates Expiry
In- Date
stock
life-span of laboratory
reagents varies
124

125. define criteria for supplies and services to
be purchased
use information from other laboratories
evaluate before purchase and after
receipt
125

126. Understand government
requirements
Negotiate Review
Contracts
prices
Assure reliable
availability, delivery
Determine
payment
mechanisms
126

127. Assign
responsibility
Maintain
inventory system Analyze
in all storage needs
areas
INVENTORY
CONTROL
Establish Establish
system for minimum stock
receiving, storing needs
Develop
forms and logs
127

128. listing all tests in the laboratory
identifying all supplies needed for
each test
using available information to
estimate usage
128

129. Unit of
count
Storage Usage/
space, month
(quantification)
conditions
Item
Description
Order lead
time/ Priority
delivery Level
time
129

130. consumption-based method
morbidity-based method
130

131. 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

132. 90
80
70
60 Slides
50
40 Immersion Oil
30
20 Collection
10 containers
0
1st 2nd 3rd 4th
Qtr Qtr Qtr Qtr
132

133. based on actual number of episodes
must take into account:
• population size
• disease incidence
• accuracy of morbidity data
• treatment guidelines
133

134. 180
160
140
120
Influenza
100
Diarrhea
80
TB
60
40
20
0
1st Qtr 2nd Qtr 3rd Qtr 4th Qtr
134

135. 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.

136. Includes:
 name and signature
 date of receipt
 quantity
 date of expiry
 minimum stock
 stock balance
Other information:
– shelf number
– destination
136

137. 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

138. Use clearly visible dating labels
date opened
date expired
138

139. Assign
responsibility
Maintain
Update Inventory inventory system
records Control in all storage
areas
Conduct weekly
physical counts 139

140. advantages
• exact current state of stock
• management of expiration dates
• makes inventory tasks easier
drawbacks
• on-site computer is needed
• requires trained staff 140

141. 141

142. The result of any laboratory
examination is only as good as
the sample received in the
laboratory.
142

143. 143

144. Laboratory
Handbook
Policies & Practices
144

145. • 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
145

146.  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

147. Provide sample
Provide appropriate
collection information
What- When- How
containers and supplies
Define a good
Assess all samples - labeling system
preexamination

148. • patient ID
• tests requested
• time and date
of sample collection
• source of sample,
when appropriate
• clinical data,
where indicated
• contact information of
requesting physician
148

149. • patient preparation
• patient identification
• type of sample
required
• type of container
needed
• labeling
• special handling
• safety precautions
149

150. patient’s name
patient’s unique ID
number
test ordered
time and date of
collection
collector’s initials
150

151. delays in reporting test results
unnecessary re-draws/re-tests
decreased customer satisfaction
increased costs
incorrect diagnosis / treatment
injury and death
151

152. • Verify
–completeness of test
request
–appropriateness of sample
–information on label
• Record in register or log
• Enforce sample rejection
criteria
152

153. Labeled samples, Spilled urine sample,
completed requisitions a cause for rejection
153

154. inform authorized person
request another sample
record rejected samples
retain rejected sample
based on preset criteria
extraordinary circumstances may
require testing suboptimal samples
154

155. date and time of collection
date and time of receipt
sample type
patient name
demographics as required
laboratory assigned identification
tests to be performed
155

156. Handle all samples as if
infectious
156

157. • set policy for sample disposal
• compliance with local and country
regulations
• disinfection procedures
157

158. – temperature
– preservation of sample
– special transport containers
– time limitations
158

159. 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

160. Category B: infectious substances
not included in Category A
less stringent triple packaging
no dangerous goods
documentation required
160

161. 161

162. 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

163. The goal of QC is to detect errors
and correct them before patients’
results are reported.
163

164. Measure the quantity of a particular
substance in a sample.
Measurements should be both
accurate and precise
164

165. Examinations that do not have
numerical results
growth or no growth
positive or negative
reactive or non-
reactive
color change
165

166. 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

167. Establish include
written corrective
policies and actions
procedures
Review QC
Train
QC Program
all staff
data Steps
Assure
complete
documentation
167

168. material that contains the
substance being analyzed
include with patient samples when
performing a test
used to validate reliability of the test
system
run after calibrating the instrument
run periodically during testing
168

169. 169

170. Calibrators Controls
A substance with a specific A substance similar to
concentration. patients’ samples that
has an established
Calibrators are used to set concentration.
(calibrate) the measuring
points on a scale. Controls are used to ensure
the procedure is working
1 2 3 4 5 properly.
1 2 3 4 5
170

171. 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

172. may be
frozen, freeze-
dried, or chemically
preserved
requires very
accurate
reconstitution if this
step is necessary
172

173. commercially prepared
made ―in house‖
obtained from another
laboratory, usually central or
reference laboratory
173

174. Target value predetermined
ASSAYED
Verify and use
Target value not predetermined
UNASSAYED
Full assay required before using
In-house pooled sera
“IN-HOUSE”
Full assay, validation
174

175. • values cover medical decision points
• similar to the test sample
• controls are usually available in
high, normal, and low ranges
175

176. obtain control material
run each control 20
times over 30 days
3SD
calculate mean and 2SD
+/-1,2,3 Standard 1SD
Deviations Mean
1SD
2SD 176

177. Variability is a normal occurrence
when a control is tested repeatedly
Performance
Operator Environmental
characteristics of
technique
conditions the measurement
177

178. Although variable, sets of data are
distributed around a central value
F
r
e
q
u
e
n
c
y
Measurement
178

179. 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

180. Not all central values are the same.
Mean Mode
F Median
r
e
q
u
e
n
c
y
Measurement
180

181. 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

182. Quality Control is used to monitor
the accuracy and the precision of the
assay.
What are
accuracy
and
precision?
182

183. The closeness of measurements
to the true value
The amount of variation in the
measurements
The difference between the
expectation of a test result and an
accepted reference value
183

184. Accurate Precise
and Precise but Biased Imprecise
Accurate = Precise but not Biased
184

185. For a set of data with a X
normal distribution, a
Frequency
random measurement will
fall within: 68.2%
+ 1 SD 68.3% of the time 95.5%
99.7%
+ 2 SD 95.5% of the time
-3s- 2s -1s Mean +1s +2s +3s
+ 3 SD 99.7% of the time
185

186. Graphically Representing Control Ranges
186

187. 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

188. Draw lines for Mean and SDs
(calculated from 20 controls)
Chart name: Lot number:
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
188

189. Number of Controls
Interpretation depends on number of
controls run with patients’ samples.
Good: If one control:
accept results if control is within ± 2SD
unless shift or trend
Better: If 2 levels of controls
apply Westgard multirule system
189

190. : variation in QC results
with no pattern- only a cause for
rejection if outside 2SDs.
: not acceptable,
correct the source of error
Examples:
– 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

191. Levey-Jennings Chart
Shift
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
191

192. Levey-Jennings Chart
Trend
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
192

193. 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

194. Solving out-of-control problems
identify problem
refer to established
policies and procedures
for remedial action
194

195. • 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

196. • microscopic examinations
• dipsticks
• serologic procedures
• microbiological procedures
• any reaction that produces non-numeric
results
196

197. built-in controls
control materials that
mimic patient samples
reference organisms
197

198. 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

199. reference strains
in-house developed strains
predictable reactions
in stains and media
ensure media,
reagents and supplies
work as intended
199

200. ATCC-American Type Culture
Collection
NTCC-National Type Culture
Collection (UK)
CIP- Pasteur Institute Collection
(France)
200

201. use established procedure for
preparation or reconstitution
label: content, concentration, date
prepared and placed in
service, expiration, initials
store appropriately
201

202. check with known organisms or cells
examine for crystal shards or for
precipitation
examine for contaminants such as
bacteria and fungi
Left:
Wright stain
Right:
Gram stain
202

203. verify performance of all media
in-house prepared: all batches
commercially prepared: new lot only
MacConkey Agar
QC
Left: non-lactose
fermenter
Right: lactose
fermenter
203

204.  out-dated
 dried-out
 contaminated
Human blood should not be used because:
 too much batch to batch variation
may include inhibitory substances,
including antimicrobials
may contain biohazards
(e.g., hepatitis virus)
204

205. 205

206. Documents and Records—How do they
differ?
Documents Records
 communicate  capture information
information via on worksheets,
policies, processes, forms, labels, and
and procedures charts
 need updating  permanent, do not
change
RECORDS
206

207. Why do laboratories need to
manage documents and records?
To find information
whenever it is needed!
207

208. Information is the
major product
of the laboratory.
208

209. Policies
Laboratory
Documents
Procedures Processes
209

210. 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

211. “How to do it”
“How it happens”
“What to do”
211

212. Documents are the communicators
of the quality management system
Verbal instructions often are:
• not heard
• misunderstood
• quickly forgotten
• difficult to follow
212

213. Why are documents important?
• essential guidelines for laboratory
• quality manual
• SOPs
• reference materials
• required by formal laboratory
standards
213

214. 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

215. Good Documents are:
• clear
• concise
• user-friendly
• explicit
• accurate
• up-to-date
215

216. 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

217. 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

218. 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 basis
218

219. 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

220. Complete Standardized Header
Use at the top of the first page only
220

221. Reduced Standardized Header
• other pages of every procedure
• use at the top of all other pages
221

222. When Preparing SOPs
determine
procedure
to use
establish
assess
means for
scientific
updating
validity
gather all include
documents each step

223. 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

224. 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

225. 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

226. Job Aids
226

227. Document Control
assures that the
ensures availability
most current
when needed
version is used

228. Document Preparation and Control
Process
Preparation
Issue
Distribution
Review
Revision Approval
228

229. Common Document Control Problems
• outdated documents
• too many documents are
distributed and the
system
cannot be maintained
• lack of control of
documents
of external and internal
origin
229

230. Sample
log book
or register
Patient
test Workbooks
reports Worksheets
EQA /
Instrument
PT
printouts
records
Quality
control Maintenance
data records
230

231. Personnel
records
Critical Internal
communications audits
results
External
Customer
audits
feedback
results
User Continuous
surveys improvement
231

232. Test Report Contents ISO 15189
• test identification • primary sample type
• laboratory identification • results (SI units)
• patient unique • biological reference
identification and intervals
location
• name and address of • interpretive comments
requestor • person authorizing
• date and time of release, with signature
collection when possible
• time of receipt in lab • note if reporting a
• date and time of release corrected result
of report

233. 233

234. The test result is the final
product of the laboratory.
Quality Lab
Report
234

235. Establish processes for
managing data
Paper- Quality Lab Report
based ID 0905120047
Patient  accessible
information
 accurate
 timely
 secure
 confidential
Electronic  private
235

236. Unique
identifiers
samples,
Effective patients Standardized
communication request forms
Effective
reporting Important Logs,
systems worksheets
elements
Confidential Checking
Data processes
protection
236

237. safeguard a patient’s privacy
assure laboratory data
confidentiality
237

238. Paper-based systems
• use durable materials for recording
• store records properly
Computerized systems
• schedule regular backup of data
238

239. Data
incomplete
Computer
ID
systems
insufficient
incompatible
Common
Transmission Problems Forms
errors inadequate
Data
Archiving
organized
poor
poorly
239

240. Error
Integrate reduction QC
with other
sites
Data
Financial
retrieval
management
options
Detailed,
Access
legible
control
reports
Track,
Track
analyze
reports
trends
240

241. Training:
time
and money
Adapting
Back-up
to a new
requirements
system
Costs:
purchase
and
maintenance
241

242. 242

243. Any event that has a negative impact
on an organization, includes
personnel, product, equipment, or
the environment.
243

244. • proficiency testing error
• no action on out of range controls
• false negative result
• late reports
• missing reports
• complaints
• laboratory accident
244

245. individual
equipment responsibilities
not properly unclear
maintained no written
procedures
QC, EQA Common written
procedures
not
performed
CAUSES not followed
of Error
test kits training
not stored transcription not done
properly errors or
checks not completed
not done
245

246. THE PATIENT Test selection Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport Report Creation
Result Interpretation Postexamination Phase
246

247. wrong sample collected
sample mislabeled or
unlabeled
sample transported
inappropriately
reagents or test kits
damaged by improper
storage
247

248. incorrect timing of test
results reported when control
results out of range
improper dilution and
pipetting of sample or
reagents
reagents stored inappropriately
248

249. transcription error in reporting
report illegible
report sent to the wrong
location
report not sent
249

250. Awareness
Communicate Investigate
ACTION
250

251. How are occurrences detected?
Customer
satisfaction
Accreditation Monitoring
Certification complaints
Management
Seeking Review Internal
OFIs audits
External
Quality
audits
indicators
PT / EQA
251

252. Learn from the event
and avoid its recurrence
Preventive
actions Corrective
actions
See the
potential
EVENT
event and
plan to
avoid it
Remedial
actions
Address the event
and its consequences
252

253. 254

254. • learn ―where we are‖ in terms of
quality management
• measure gaps
• need information for:
planning and implementation
monitoring
continuous improvement
255

255. Attention
to detail
Communicate
effectively Trained
Important
Skills
for
Auditors
Technical/
Quality
management
Diplomatic
expertise
256

256. Continuous
monitoring is the
key element to
success in the
Quality System
257

257. ―It isn’t what you
find…
it’s what you do
about what you
find.‖
-Philip Crosby
258

258. EQA
Methods
Proficiency Rechecking On-site
Testing Retesting Evaluation
259

259.  comparison among different test
sites
 early warning for systemic problems
 objective evidence of testing quality
 areas that need improvement
 training needs
260

260. • important for improvement
• a measure of laboratory
performance
261

261. 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

262. PT organization Laboratory
/provider
Analyze
PT samples
sent regularly
Return
results
Evaluation
Receive
PT performance PT report
report
Corrective Actions
264

263. ISO 15189
PT Patient
Laboratory 1
sample sample
Laboratory 2
Analyze same manner
with same personnel
Final PT
report
Improvement
No discussion received
between labs
265

264. Information received from PT
participation must be directed
toward improvement in the
laboratory to receive the full
value.
266

265.  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

266.  tested by reference laboratory
 performed on dried blood spots or serum
 not blinded
 statistically significant
 primarily used to assess HIV rapid testing
268

267. EQA
Take
Corrective
Action
Identify
problems
271

268. ISO
CLSI
CEN
WHO
272

269. world's largest
developer and
publisher of
standards are applicable
international
to many kinds of
standards
organizations including
clinical and public health
laboratories
273

270. global, nonprof
it, standards-
developing
promotes the development
organization
and use of voluntary
consensus standards and
guidelines within the
health care community
274

271. national
standards bodies
in the European
general terms include Economic
openness and Community and
transparency, consensus, associated
and integration countries
275

272. has developed several standards for
disease-specific diagnostic
laboratories, such as
polio, tuberculosis, influenza, measles
276

273. Accreditation Body
Standards
Assessors
User laboratory
278

274. Approved Knowledgeable
Certification
and
Accreditation
Bodies Standards-
based
Competent
staff
Objective
279

275. Where is your Laboratory?
Reference
Laboratory
Laboratory
Laboratory Accreditation
Certification
Licensure
280

276. not one to be taken lightly
or without forethought
commitment planning
Requirements
knowledge resources
281

277. Accreditation does not guarantee success,
it is only one step along the quality journey
QUALITY
MANAGEMENT
ERROR CUSTOMER
REDUCTION SATISFACTION
CONTINUAL
IMPROVEMENT
ACCREDITATION
282

278. Accredited laboratories tend to:
perform better on proficiency
testing
are more likely to have a working
quality management system
283

279. 2010
2007
MAINTAINED
PRIMARY
2009
MAINTAINED
2008
It is an
ACHIEVEMENT
MAINTAINED to maintain
accreditation
284

280. It is an accomplishment
to receive accreditation
2007
PRIMARY
285

281. 286

282. Philip Crosby
Four Absolutes of Quality
Management
1979
287

283. 288

284. Requires:
• commitment from all staff
• planning
• knowledge of monitoring tools
• resources
289

285. Laboratory
Public Health
Community
Patients Physicians
Health care
provider
290

286. Good customer service
provides:
• valuable information for best patient care
• valuable information to improve
surveillance
• professional image of laboratory
293

287. complaint
monitoring
interviews, quality
focus groups indicators
MONITOR
satisfaction internal
surveys audit
management
review
294

288. Complaints
Actual
dissatisfied
customers!
295

289. Monitoring
Conducting
quality indicators
internal
audits
Reviewing by
management
ACTION
296

290. planned
analyzed
in a timely organized
manner
Successful
surveys
no leading
questions, pre-tested
unbiased
297

291. An active
Quality Management System
ensures Laboratories Meet
ALL Client Requirements
298

292. 299

293. W. Edwards Deming
14 Points for Quality
Two points address continual
improvement:
• create constancy of purpose for
improvement
• improve constantly and forever
300

294. Plan
Act Do
Check
301

295. Continual Improvement
(ISO 15189:2007)
develop plan
for
identify improvement
potential
sources
of error
adjust the implement
action plan
and
modify the
system review the
effectiveness
of action
302

296. Lean
Optimizing
space,
time, and
activity to
improve the
physical paths of
workflow.
303

297. Organized processes to assist in decision
making for continual improvement:
 control
 define
 measure
 analyze
 improve
304

298. • indicate performance
• determine quality
• highlight concerns
• identify areas needing
further study
• track changes over
time
305

299. Use an indicator only as
long as it provides
useful
information.
Don’t get tied to
your indicators.
306

300. Use an indicator only as
long as it provides
useful
information.
Don’t get tied to
your indicators.
307

301. 308

302. 309