Impact of Laboratory Automation on Quality and TRT. Evaluating and Selecting an Automation System

1. Prof. Moustafa Rizk
5/16/2022 2:31 AM 1

2.  What is automation?
 Recommended process for a clinical lab to evaluate their need for
automation and to determine what solution(s) will work best.
 Examples of automation activities not involving track and robotics
 How to measure the benefit of what you did.
 Examples of modular pre-or post-analytic and task-targeted
automation systems
 Total Quality Management
5/16/2022 2:31 AM 2

3.  Generally speaking, it is automation of
manual processes and involves automated
or robotic equipment.
5/16/2022 2:31 AM 3

4.  However, for purposes of this presentation
and especially for smaller laboratories with
limited capital funds, re-engineering of
manual processes is part of the definition.
5/16/2022 2:31 AM 4

5.  Over the next several years, options for
automated systems can be expected to
increase along with the technical
sophistication of these systems.
 The shortage of qualified medical
technologists is only going to get worse.
Automation and process
re-engineering are
the chief ways to address this.
5/16/2022 2:31 AM 5

6.  Incomplete understanding of
current environment...processes,
costs, customer expectations
 Loss in flexibility due to fixed processes and
limited throughput
 Unrealistic expectations
of system...cost reduction,
throughput, return
on investment
5/16/2022 2:31 AM 6

7.  Unplanned and poorly developed
‘workarounds’ required to interface
automation with manual processes
 Unclear expectations of system functionality
 Overbuilt and unnecessarily complicated
system design
5/16/2022 2:31 AM 7

8.  Inadequate technical support
 Hidden costs...labor, supplies
maintenance
 Failure to optimize current
processes prior to automation→never
automate a poor process!
5/16/2022 2:31 AM 8

9. 1. Evaluation of needs (move current state to
desired state)
2. Logistics and handling issues
3. Facilities and space considerations
4. Temperature considerations
5. Mapping workflow, timing workflow
6. Finding bottlenecks and time wasters
7. Identify possible solutions to meet needs
8. Evaluation of alternatives
9. Progress measures
10. Cost justification
5/16/2022 2:31 AM 9

10.  What is laboratory’s specimen volume?
 Chart specimen count by hour of day and
day of week
5/16/2022 2:31 AM 10

11.  What percentage are centrifuged?
 What percentage are aliquotted?
5/16/2022 2:31 AM 11

12.  What percentage of specimens are shared
between two lab sections?
 What percentage of specimens are
refrigerated or frozen?
Whole blood: CBP, ESR and osmotic fragility.
Plasma : PT and other coagulation factors.
Serum : Most chemical analyses, Hormones
5/16/2022 2:31 AM 12

13.  How and where do specimens arrive?Courier
vehicles, tube system, dumb waiter, window,
phlebotomists, patient walk-ins, nurse
delivery?Are these near each other or in
separate areas?
 Patient registration -is it required, is it before
or after processing, where is it located, who
does it -lab personnel or hospital personnel?
5/16/2022 2:31 AM 13

14.  Patient identification: is there a wrist band
bar code system linked to the LIS?
 How do phlebotomists
verify patient ID?
5/16/2022 2:31 AM 14

15.  Do nurses or patient care assistants (i.e.,
employees not under lab control) draw or
collect specimens?
 For tests ordered on the floors, do LIS labels
print on the floors or in the lab?
5/16/2022 2:31 AM 15

16.  Where are tubes centrifuged? Specimen
Processing or at other labs?
 Pour-offs and aliquotting –what is the
workload?
5/16/2022 2:31 AM 16

17.  Sorting -how much sorting of specimens
occurs -in Specimen Processing and in lab
sections?
 Transport -delivery by Specimen Processing
or pick-up by labs?
What are the distances
covered?
5/16/2022 2:31 AM 17

18.  How, where, and for how long , archived
specimens are stored?
 Centralized or decentralized?
 Manual system or using bar codes ?
5/16/2022 2:31 AM 18

19.  What is the percentage of repeat testing?
 What is the percentage of additional testing
requested to be added to archived
specimens?
5/16/2022 2:31 AM 19

20.  If there is the opportunity to design a new
facility, great.Whether yes or no, here are
several worthwhile ideas:
 Arrange the facilities in a manner that follows
the flow of the specimens.
5/16/2022 2:31 AM 20

21.  Position highest volume testing (Chemistry,
Hematology, etc.) closest to Specimen
Receiving and lowest volume testing furthest
away.
 Avoid having all lab traffic go through a key
area such as Specimen Receiving.
 Position client service and exception handling
activities in or close to Specimen Receiving.
5/16/2022 2:31 AM 21

22.  Specimens flows
 Data flow diagram-done at different layers of
detail
 Workload map-can be used in simulation
studies
5/16/2022 2:31 AM 22

23.  Purpose is to count and time everything in
relation to the workflow map.
 One idea: use pre-printed slips taped to tubes,
racks, etc. to note the date & time of each step,
number of tubes in each batch, employee ID at
that step, etc.
 Analysis of data leads to elapsed times each step
takes at different times of day.
 Identifies bottlenecks, idling time, and time
wasters.
5/16/2022 2:31 AM 23

24.  Tracking Local &
 Category 21:30 23:30 1:30 3:30 7:00 8:00 9:00 10:00
10:30 12:00 Airborne 14:30 Totals
 No. of Boxes 20 41 9 36 10 6 3
6 18 6 3 4 162
 Specimens 299 1418 475 1305 402 409 50 279
53 200 12 86 4988
 No. of Tracking Slips 22 92 37 106 16 9 3
8 8 12 4 3 320
 Median IntervalTimes
 Arrival to Unpack 0:21 0:25 0:03 0:30 0:05 0:00 0:00
0:03 0:10 0:07 0:00 0:00
 Unpacking Time Per Box 0:04 0:06 0:25 0:09 0:16 0:10 0:07
0:10 0:02 0:03 0:03 0:06
 Arrival to Manifest 0:20 0:45 0:03 0:33 0:15 0:06 0:02
0:04 0:16 0:13 0:00 0:03
 Manifest to ROE 0:16 0:37 0:35 0:41 0:26 1:34 1:04
0:22 0:33 0:28 0:27 0:32
 ROE to Labeled 0:24 0:41 0:22 0:26 0:47 1:33 1:56
2:13 2:21 1:14 0:23 0:50
 Labeled to Sort 0:31 0:18 0:25 0:28 0:29 0:21 0:00
0:40 0:16 0:45 0:30 0:53
 ARRIVAL to SORT by ROE 1:17 2:37 1:30 2:28 2:19 3:20 4:00
3:19 3:19 2:48 2:05 1:56
 Manifest to SPR 0:10 1:43 1:35 1:50 1:15 0:30 NA
0:32 NA 1:16 1:15 NA
 SPR Start to Finish 0:09 0:05 0:05 0:07 0:03 0:02 NA
1:30 NA 0:05 0:05 NA
 SPR Finish to Sort 0:59 0:19 0:10 0:37 1:19 1:09 NA
0:04 NA 0:17 0:10 NA
 ARRIVAL to SORT by SPR 1:35 3:08 1:53 3:18 2:52 2:40 NA
2:12 NA 1:57 1:30 NA
 MEDIAN DELAY or (GAIN) for SPR 0:17 0:30 0:22 0:50 0:33 (0:40)
NA (1:07) NA (0:51) (0:35) NA
 ARRIVAL TO SORT, OVERALL 1:30 2:42 1:43 2:28 2:19 2:40 4:00
2:50 3:19 2:00 2:05 1:56
 Pour Off Start to Finish 4:12 NA 4:11 5:20 NA 4:50 NA
NA NA NA NA NA
 Pour Off Start to Sort 4:25 NA 4:16 5:35 NA 5:24 NA
NA NA NA NA NA
 Pour Offs Arrival to Sort 5:40 NA 13:01 10:40 NA 8:04 NA
NA NA NA NA NA
 Sort to Lab Pick Up 6:40 3:55 3:05 0:40 0:20 0:15 1:15
0:31 1:24 0:21 1:19 0:02
 Sort to Log Out Table 0:00 NA NA NA NA 0:01 NA
0:12 NA NA NA NA
 Time to Wait for Pick Up 6:25 NA NA 1:32 NA 0:14 NA
0:41 NA NA NA NA
 Pick Up to UHSC Receipt 0:14 NA NA 0:23 NA 0:57 NA
NA NA NA NA NA
 Label to ROU 3:46 1:59 2:19 4:01 NA NA 8:25
7:02 6:16 5:30 NA 3:58
 ROE to ROU 4:16 2:35 2:40 4:33 NA NA 10:21
8:40 7:42 7:05 NA 4:36
 ROU to Document Scan 8:09 5:43 5:21 20:23 NA NA 7:38
8:14 8:23 8:25 NA 8:20
5/16/2022 2:31 AM 24

25.  Use quality and turn-around time measures,
workflow, and timing studies to find bottlenecks
and potential areas for re-engineering.
 Re-engineering of processes should precede
introduction of automation.
 Not all solutions need to involve automation
 Several seemingly small, low-cost re-
engineering projects sometimes have more
impact on laboratory performance than an
expensive automation project.
 “Automating a poor process still leaves one with
a poor process.”
5/16/2022 2:31 AM 25

26.  Use continuous quality improvement (CQI) tools such
as Lean and Six Sigma to foster process
improvements
 Standardize processing procedures to “best practice”
solutions with fewest “hand-offs.”
 Reduce or eliminate non-value added handling and
sorting.
 Eliminate “running around” to find shared specimens.
 Redesign workstations so that individuals process
orders from start to finish.
 Maximize the number of specimens at test run start
times.
5/16/2022 2:31 AM 26

27. EXAMPLES OF MODULAR
PREANALYTICAL ORTASK-
TARGETED AUTOMATION
SYSTEMS
5/16/2022 2:31 AM 27

28. Beckman Coulter’s AutoMate automation
system for labs with daily volumes of 500 –1500
specimens features an LED machine vision
system that inspects tubes through as many as
three labels to find the top of the serum and
the top of the packed red cells, then calculate
the serum volume based on tube diameter.
5/16/2022 2:31 AM 28

29. Motoman AutoSorter III –centrifugation, decapping, and
racking into analyzer specific racks
5/16/2022 2:31 AM 29

30. PVTVSII Aliquotter
PVT RSA Pro Aliquotting Sorting
System
PVT 1000 Sorter
5/16/2022 2:31 AM 30

31. 5/16/2022 2:31 AM 31

32. EXAMPLES OF
TOTAL LAB
AUTOMATION
SYSTEMS
5/16/2022 2:31 AM 32

33. AcceleratorTM Abbott Diagnostics (Inpeco)
5/16/2022 2:31 AM 33

34. Beckman Coulter Power Processor at Ohio State University
Hospital
5/16/2022 2:31 AM 34

35. Efficiency SeriesTM by Integrated Laboratory Automation Solutions, Inc.
(ILAS)(www.lab-ilas.com) has successfully connected to the Motoman AutoSorter III
(as shown here) and has point-in-space sampling connections with the Advia Centaur,
Beckman Coulter DxI, Dimension RXL, Ortho Fusion 5.1, Stago STA R,andTosoh AIA
2000 analyzers.
5/16/2022 2:31 AM 35

36. Ortho-Clinical Diagnostics
Single tube carrier
Micro-Chip contains
Sample ID,Tube Size, STAT,
Route Info
Multiple tube sizes
accepted (12/13 x 75/100,
16x 100)
Centrifuge ModuleUp to
300 tubes / hr
DecapperUp to 500
samples / hour
Ortho-Clinical Diagnostics
(Raritan, NJ) andThermo
Electron OCD, Finland
enGen ™
5/16/2022 2:31 AM 36

37. Roche/Hitachi Pre-Analytical Modular System
5/16/2022 2:31 AM 37

38. Siemens
(Bayer) ADVIA®LabCell®
(Dade Behring) Stream LAB®Analytical
Workcell
TheVersa CellTM system
merges the Immulite 2000
analyzer with either theADVIA
1800 or the Centaur XP
analyzers
5/16/2022 2:31 AM 38

39. A Peek Into the Future of Clinical LaboratoryAutomation
NewTrackTechnologies
FlexLink X45 conveyor
system with RFID pucks has
capacities (speeds) of up to
3000 pucks per hour
(20m/sec)
MagneMotion’s
MagneMoverTMLite
transport system uses Linear
Synchronous Motors (LSM)
and magnetic pucks to
achieve capacities (speeds) of
up to 18,000 pucks per hour
(120m/sec)
Automated Inspection
Systems (Machine
Vision)
Inspections for clots,
hemolysis, lipemia, and
icterus
Inspections for tube
type and size and cap
color
Inspections for
mislabeled specimens
5/16/2022 2:31 AM 39

40.  Laboratory testing plays a
critical role in health
assessment, health care, and
ultimately, the public health.
 Decisions about diagnosis,
prognosis and treatment are
based on the results and
interpretations of laboratory
tests, and irreversible harm may
be caused by erroneous results.
 In fact, estimates show that
clinical laboratories provide
about two-thirds of all objective
information on patients’ health
status

41.  Hence, every clinical chemistry laboratory
must have adequate procedures to assure
quality of the results reported
 Total quality management(TQM) means that
every variable that could possibly affect the
quality of the test results has been controlled.

42.  The quality of laboratory services depends upon many
characteristics, such as painless acquisition of a specimen,
specimen analysis, correctness of the test result, proper
documentation and reporting, quick turn-around time for
the test, and reasonable cost.
 To achieve good laboratory quality; the lab has to establish
the following, qualified and experienced staff, calibrated
and maintained equipment, standardized methods,
adequate checking, and lastly accurate recording and
reporting

43.  To ensure consistent specimen quality; specimen
collection and handling policies should be based on
specific guidelines such as those established by
National Committee for Clinical Laboratory
Standards (NCCLS), recently known as Clinical and
Laboratory Standards Institute (CLSI)
 Many of these variables are outside the laboratory,
hence their monitoring and control requires the
integrated efforts of many individuals and hospital
departments.

44.  The combination of these processes is now
considered to be part of the “total quality
system”.
 Laboratory quality management should
involve all activities in the laboratory

45. Variables
 Preanalytical
 Analytical
 Postanalytical
The major aim of the quality system is to reduce
or, ideally eliminate all defects within the whole
laboratory processes.

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

47. Preanalytical
Variables

48. Variables to consider include :
A - AppropriateTest Selection and ordering
B - Patient Preparation
C - Patient and Specimen Identification
D - Specimen Collection
E - SpecimenTransport
F - Specimen Separation and Aliquoting
G - Laboratory Logs and Work Lists
H - Transcription Errors
I - TurnaroundTime (TAT)

49. A - AppropriateTest Selection and
ordering
Knowledge of the indications for testing,
including test sensitivity and specificity
for the patient's condition is very
important.
Using appropriate test panels,cost,….

50. - Laboratory tests are affected by many factors,
such as recent food intake, alcohol, drugs, smoking,
caffeine, change in posture, bed rest, physical
exercise, sleep, stress, time of the day, and
menstruation.
- Instructions concerning patient preparation should
be included in ‘hospital procedure manuals’, and
should be transmitted to patients both in the form
of written and oral instructions.

51. Samples should be taken in the early morning after awaking
and about 8-10 h after last ingestion of food.
If the patient has eaten recently and the physician wants the
test to be performed anyway this should be noted on the
requisition form as non fasting.
Fasting includes abstinence of all food and drinks except
water .
Refraining from exercise and stressful activity the night
before and just prior to blood collection

52. Cortisol and ACTH, samples should be
collected at 8am and 8pm
Growth hormone : 8am after full awakening

53. 1-Fasting blood: glucose, insulin, C-peptide after 6-8h fast
2-Post-prandial blood glucose: 2 h after a meal with or
without intake of treatment as specified by the physician.
3-Oral glucose tolerance test: normal carbohydrate meal
should be taken 3 days before the test, sample collection
should be done after 10h fast, the patient is given 75g
glucose for non pregnant adults oraly.

54.  4-Lipid profile: fasting hours should be 12-14
5-TDM: the drug should be taken regularly for
5 days prior to sample collection, there
should be no vomiting or diarrhea 48h before
the analysis. Refer to the attachment for
timing of trough and peak schedule

55. Urine: patient should be provided with both written and
spoken instructions when a clean catch sample is required.
The 2Nd voided morning urine sample is preferred
Collection
.

56. • Hydroxyprolene: the patient should stop
eating meat and gelatin for 48h.
• Catecholamines andVMA: the patient
should stop tea, coffee, chocolate, vanilla,
soda, and banana for 72 hours.
• Aldosterone and Renin: the patient should
decrease dietary salt for 72 hours

57. C - Patient and Specimen Identification
Many errors arise from handwritten labels
and request forms.These can be eliminated
by :
1- Careful comparison of the patient’s name
and hospital number with those on the
request form and specimen collection labels.
2-The use of bar code technology significantly
reduces identification problems

58.  1-The following information on the requisition form should be
completed by the nurse:
 1 name 2 sex
 3 age 4 room number
 5 bed number 6 department
 7 patient medical record number
 8 date physician ordering the analysis

59.  Time of sample collection, specimen type.
 Date andTime collected: the date ,time and name of the
individual collecting the specimen
these information should be completed by the nurse when
specimens are collected on the unit such as urine, stool,
CSF and body fluid specimens

62. D - Specimen Collection :
1- Causes of Specimen Collection Problems :
a- Prolonged application of tourniquet:
This can lead to :
(i) Anoxia: which causes leakage of small solutes
from cell, e.g., K+.
(ii) Haemoconcentration: which causes an increase in
protein and protein-bound constituents. calcium,
billirubin, cholesterol, drugs, and enzymes.
Ideally tourniquet time should be brief (one minute),
and prolonged fist clenching should be discouraged

63. b- Intravenous infusion in an arm from
which blood has been withdrawn results in
dilution or contamination.
c- Haemolysis:
(i) Affects the concentration of analytes with
RBC/plasma concentration differential (e.g.
LDH, ALT, AST, K+, Pi).
(ii) Causes interference in some methods (e.g.
bilirubin, albumin).

64. 1- Causes of Specimen Collection Problems
d-Inappropriate anticoagulants or preservatives:
 e.g., EDTA, oxalate and citrate cause a
decrease in calcium
 Gel or serum separator tubes should not be
used for drug levels as the drug may be
absorbed into the gel.

65. 2 - How to Avoid Specimen Collection Problems:
a- Assigning a well trained team for specimen collection.
b-The team should be given clear instructions on sample
collection.
c- The identification of the person collecting the specimen
should be maintained.
d- Physicians should be encouraged to report inconsistent
results.
e-Any problem should be reviewed with the person in
charge.
f- Those showing quality performance should be awarded.

66. E - SpecimenTransport:
 Stability of the specimen during its transport is critical.
 The effect of time (e.g. in case of glucose), temperature (e.g. on
blood gases, NH3, PTH),
 exposure to light (e.g. on bilirubin and CK) may have an impact on
stability.
 - serum or plasma should be physically separated from contact
with cells as soon as possible
 -A maximum limit of two hours from the time of collection is
recommended.
 - A contact time of less than two hours is recommended for
potassium, phosphorus, glucose, ACTH, cortisol, lactic acid and
catecholamines

67. F - Specimen Processing ( Separation and Aliquoting):
These are under laboratory control.The main variables are :
1- Centrifuge Performance:
This is monitored by checking the speed, timer, and
temperature.
2- Container Monitoring:
a - Collection tubes, stoppers, pipets and aliquot tubes are sources
of calcium and trace metal contamination.
b-Cork and rubber stoppers increase calcium by 10- 15%.
c-Some plastic materials adsorb trace amounts of some
analytes, and should not be used for substances in
low concentrations, e.g. PTH.

68. 3 - Personnel Monitoring:
a - Personnel who process laboratory specimens should be
carefully trained and supervised
b - Written procedure manuals should be available.
c - Personnel performance and personnel safety should be
monitored.
d - The throughput time is an important part of the
performance which can be calculated by recording the time of
specimen arrival and the time when processing has been
completed.
e - The identification of the technologist should be recorded to
facilitate the detection and correction of problems.

69. G - Laboratory Logs andWork Lists:
1 -Once the specimen and request form arrive in the
laboratory, we should:
a - Check the matching of the patient’s name and
identification number on the request form and specimen
collection label.
b - Inspect for adequacy of volume.
c - Inspect for freedom from lipaemia or haemolysis.
d - Check that the requested tests are suitable for the
received sample.
2 - Then record the identification information, arrival time
and requested tests in a “Master Log Book”.
3 - If assays are to be done immediately, record the
specimen identification in “Work Sheets”.

70. 4 - After assay, if the run is “in control”, test results are
transferred to the “Result of Report Forms” for reporting.
However, prior to reporting of results, we should recheck
for transcription errors by comparing the results on the
report form with those on the master log.
5 - If specimens are to be retested after dilution or there
are any assay problems, this should be indicated on the
“Master Log” or on a “Delayed Report Log”.
6 -If the specimen is stored for subsequent analysis (i.e.
not assayed immediately), its identification, arrival time
and requested test(s) should be recorded in a “Master
Log”.

71. I - TurnaroundTime (TAT):

72.  Is the time taken from receipt of the
specimen in the lab to delivery of results to
the ward.

73.  It is imperative that the results are obtained
as soon as possible to optimize the best
possible outcome for the patients.

74.  TAT vary greatly based on individual hospitals
and the type of tests done to the patients.
 TAT varies between routine & STAT

75.  STAT testing is defined as any emergency
test ordered, requiring a turnaround time of 1
hour or less.

76.  Traditionally,TAT is affected by the three
phases: pre-analytic, analytic, and post-
analytic.

77.  The lab should prepare reports on actual turnaround
time.
 Documentation of every step; time of receipt of
request, time of sampling, time of receipt in the
lab….etc
 Comparison with previous figures for purposes of
internal control
 Share the information with other departments in
regular meetings

78. MAJOR PROBLEM
1. Delayed requests
2. Lost requests
3. Delayed sampling: patient not prepared
4. Lost samples
5. Delayed transport of samples

79. 6. Variations inTAT between:
 Regular day shift
 Regular evening shift
 Regular night shift
 Regular weekend shift
may be attributed to: diminished staff, less-
experienced personnel, less-available
equipment

80. I - TurnaroundTime (TAT):
1 -Causes of IncreasedTAT:
Delayed and lost requisitions, specimens, and reports
2 -Identification of the Cause of Delay:
This can be done by monitoring the actual times of specimen
collection, receipt in the laboratory, processing, analysis and
reporting of results.
This can be done manually or using a computer.
In the manual method, time-stamps can be used, these being placed
in blood-withdrawal areas, specimen-processing areas, result-
reporting areas, and wards.

81.  Delayed requests & sampling can be helped
by the implementation of Phlebotomy teams
in the system.

82.  Bar coding at the point-
of-phlebotomy
B-D id

84.  Standardized protocol for transport.
 Authority to reject delayed specimens.
 Clear rejection criteria to avoid wasting of
time.

85.  The use of computers and pneumatic tubes
for sample transport have reduced
turnaround time in large hospitals.
 Inter-departmental ( cross-functional teams)
meetings held to discuss turnaround time.

86.  A pneumatic tubing system consists of
stations throughout the hospital with a tube
interconnecting them. Carriers can be placed
in the tubes to carry samples to a desired
destination.This method has proved
successful in the reduction of the pre-analytic
phase of theTAT.

87.  Suitable number of centrifuges.
 Suitable number of personnel.
 Written procedure manual for different
specimens.
 Fast track for STAT.

88.  Calibration means a process of testing and adjusting an
instrument or test system to establish a correlation between
the measurement response and the concentration or amount
of the substance that is being measured by the test procedure.
 Calibration verification means the assaying of materials of
known concentration in the same manner as patient samples
to substantiate the instrument or test system's calibration
throughout the reportable range for patient test results.

89. Quality Control
1- Internal control procedures that
focus on monitoring single lab.
 Daily monitoring of the precision and accuracy of
the analytical method.
 In practice ,internal QC procedures only
detect changes in performance between
the present operation and the stable
operation that was characteristic during the
base line period when the analytical method
was thought to be operating properly .

90.  Initial method evaluation studies are essential to
ensure that systematic errors are not present before
the baseline period and the determination of the
mean and the control limits.
 The accuracy of the method should be initially
established by comparison with other analytical
methods and should continue to be monitored by
comparison with other analytical methods.

91.  Ongoing comparison -of-methods studies are
desirable to ensure that systematic errors do not
slowly increase and go undetected by internal QC
procedures.
 These ongoing comparison studies are provided by the
external QA programs, which in turn form the basis
for proficiency testing programs.

92. ProficiencyTesting (PT) :
 Periodic testing, by laboratories, of samples
received from a PT program.The PT program
grades the samples, based on the determined
value of the sample, and reports the results to
the laboratory .PT is important because it is a
tool the laboratory can use to verify the accuracy
of their testing.

93. PatientTest Management Record
keeping system
Patient identification
Confidentiality

94. Quality Assessment
Ongoing, overall plan to monitor and ensure
accurate, timely test results.

95. The quantitative management of quality requires that performance be
assessed and compared to the implied needs of customers and the defined
requirements of regulators and/or accreditors.This aspect of assessing
conformance to needs and requirements is described as:
•Validation. Action [or process] of proving that a procedure,
process, system, equipment, or method used works as expected and achieves
the intended result.
•Verification.The confirmation by examination and provision
of objective evidence that specified requirements have been fulfilled.

96. Do not fear mistakes…
fear only the absence of
constructive and
corrective responses
to those mistakes…

97.  InTheory the total error is the Random error +
the systematic error,
 In practice Random error is represented by the
SD or the CV %, on the other hand the
systematic error is represented by the Bias of
the Method.

98.  The total error is compared to what is called
Total Error Allowed (TEa) to check the
performance of the method.

99. TEa can be derived from CLIA and CAP providing
fixed limits
Total Error Limits (TEa) specify how far any result
can vary from the target value before reaching
an unacceptable Risk of Significant Error
Total Error (TE) is a function of method inaccuracy
and imprecision

100.  The calculation of total error requires four valid numbers:
 Target value (Peer Mean)
 TEa limit (CAP Survey Limit or CLIA Limit)
 Mean (Customer’s historical data, Actual)
 SD (Customer’s operating SD)

101.  The first step is to verify that
these four numbers are correct.

102. If you have the four numbers, you can use any of
the two following equations:
TE = Bias + 2 SD
%TE = %bias + 2 CV

103.  If the calculated total error is within the
specifiedTEa limits, then the method is
producing clinically acceptable results.
 If the performance of the method exceeds total
error limits, the cause must be investigated
and corrective action initiated.

104. Example 1
GLU Target Actual SD
275 269 4.5
TEa 6mg/dl or 10% (as per CAP/CLIA Limit)
So theTEa in this case will be 10% of your target value = 275 *
10% = 27.5
The Bias will be 275 - 269 = 6
TheTotal Error = Bias + 2 sd. which equals 6 + 9 = 15
TE is less thanTEa (15 < 27.5) the method is within the
acceptable performance

105. ALP Target Actual 1SD
260 320 10
TEa 30% (CAP or CLIA limit)
So theTEa in this case will be 30% of your target value
TEa= 260 * 30% =78
The Bias will be 320 - 260 = 60
Total Error = Bias + 2 SD = 60 + 20 = 80
TE is more thanTEa (80 > 78) the method is outside the
acceptable performance criteria and needs a corrective action

106. Acceptable Performance
Analyte
Target value ± 20%
Alanine aminotransferase (ALT)
Target value ± 10%
Albumin
Target value ± 30%
Alkaline phosphatase (ALP)
Target value ± 30%
Amylase
Target value ± 20%
Aspartate aminotransferase (AST)
Target value ± 0.4 mg/dL or ± 20%
Bilirubin, total
Target value ± 3 SD
Blood gas p02
Target value ± 5 mm Hg or ± 8%
Blood gas pCO2
Target value± 0.04
Blood gas pH
Target value ± 1.0 mg/dL
Calcium, total
Target value ± 5%
Chloride
Target value ± 10%
Cholesterol, total
Target value ± 30%
Cholesterol (HDL)
Target value ± 30%
Creatine kinase
MB elevated (present or absent) or Target
value ±3 SD Creatinine
Creatine kinase isoenzymes
Target value ± 0.3 mg/dl or ± 15%
Creatinine
Performance Standards for common Clinical Chemistry
Analytes as Defined by the CLIA

107. Target value ± 6 mg/dL or ±10%
Glucose
Target value ± 20%
Iron, total
Target value ± 20/0
Lactate dehydrogenase (LDH)
Target value ± 30%
LDH isoenzymes
Target value ± 25%
Magnesium
Target value ± 0.5 mmol/L
Potassium
Target value ± 4 mmol/L
Sodium
Target value ± 10%
Total protein
Target value ± 25%
Triglycerides
Target value ± 2 mg/dL or ± 9%
Blood Urea Nitrogen
Target value ± 17%
Uric acid
Performance Standards for common Clinical
Chemistry Analytes

108. I amyawning!!

109. Essential Elements for Control of
AnalyticalVariables:
1.Instrument maintenance and operation.
2.Method selection and evaluation protocol.
3.Documentation of analytical protocols.
4.Test calibration.
5.Quality control.
6.Proficiency testing.
7.Reagents and Supplies.
8.Personnel.

110. 5/16/2022 2:31 AM
110
Questions?