Laboratory Material Management: Ensuring Quality and Efficiency

 
Quality System Essential:
Inventory Management
 
Quality Management of
Laboratory Material
ISO 15189: 2012
 
9/10/2024
 
Labs for Life Project - India
 
1
 
Inventory management
 
Quantity Management
Ensuring the quantity of supplies as required
so as ensure smooth workflow
Serves to prevent stock outs and maintain
turnaround times (TAT)
 
9/10/2024
 
Labs for Life Project - India
 
2
 
Quality management – 
WHY ?
 
Reliable diagnostic services require
monitoring the quality of its inventory flow
Ensuring quality of material is an integral part
of quality assurance in the laboratory
The primary error prevention step: Quality
Reagents
 
 
9/10/2024
 
Labs for Life Project - India
 
3
 
Quality Controls (IQC/EQA) used for monitoring
of the precision/accuracy of analytical system,
are dependent on supply of quality reagents
 
Checking the quality of reagents and consumables
before procuring/using them
Important interfering variable in the final patient
report
 
9/10/2024
 
Labs for Life Project - India
 
4
 
Selection and procurement of diagnostic
laboratory materials is challenging given the
Wide choice of products and suppliers
Procurement policies prevalent in the system
A 
series of steps 
must be followed to ensure
the quality of materials used in the laboratory
 
Quality Management – 
HOW ?
 
9/10/2024
 
Labs for Life Project - India
 
5
 
9/10/2024
 
Labs for Life Project - India
 
6
 
Understanding Utility and Feasibility
 
9/10/2024
 
Labs for Life Project - India
 
7
 
Understanding requirements for the NEW
test: Initial thoughts
 
Clinical utility
Understand the needs of patients and users
Understand the performance of a test
Feasibility
Test demand
Cost effectiveness
Operationalizing
 
9/10/2024
 
Labs for Life Project - India
 
8
 
Clinical utility
(Need and Performance)
 
Discovery of novel biomarkers e.g. Lp(a),
homocysteine
Change in disease trends e.g. Swine flu
Recent advances in assay methods e.g.
Immunoassay, quantitative Trop I
Different testing objectives e.g. screening,
confirmatory, treatment monitoring, surveillance
etc
Relevance: diagnostic sensitivity & specificity,
positive & negative predictive values (Literature,
guidelines, pilot studies)
 
 
9/10/2024
 
Labs for Life Project - India
 
9
 
Feasibility
 
Cost inputs
Reagents
Quality controls
Proficiency testing
Calibrators
Equipment
Cost cutting
Improved TAT
Better performance
Improved safety
 
9/10/2024
 
Labs for Life Project - India
 
10
 
Survey the market for products
 
9/10/2024
 
Labs for Life Project - India
 
11
 
Market survey
 
Researching the available test options by
interacting with the vendors
Different product kit inserts should be
consulted to understand the differences in
performance characteristics of the various kits
 
9/10/2024
 
Labs for Life Project - India
 
12
 
Understand Operationalizing
Requirements
 
9/10/2024
 
Labs for Life Project - India
 
13
 
Challenges in Operationalizing
 
Test complexity
Compatibility with current equipment/
infrastructure/LIS
Staffing/training requirements
Space/ Open system/ Closed system
IQC/EQA requirements/ availability
Type and quantity of sample required
Patient/sample preparation required
Pre-analytical acceptance criteria and possible errors
Sample storage criteria
 
 
9/10/2024
 
Labs for Life Project - India
 
14
 
 
Initial thoughts…..
Gathering Evidence
Ensuring quality of the manufacturing process
 
9/10/2024
 
Labs for Life Project - India
 
15
 
Ensuring quality of the manufacturing
process
 
The specification may request products that
have been approved by national and
international regulatory agencies e.g. FDA, CE,
WHO etc.
 
 
9/10/2024
 
Labs for Life Project - India
 
16
 
Understanding Performance Specifications
stated by manufacturers
 
9/10/2024
 
Labs for Life Project - India
 
17
 
Quality requirements, Fitness for Purpose
 
All laboratory measurements carry some
uncertainty/error
Different testing objectives e.g. screening,
confirmatory, treatment monitoring, surveillance etc.
Lab must decide the level of error which could be
acceptable/ allowable: Quality Specifications
 
9/10/2024
 
Labs for Life Project - India
 
18
 
Quality requirements/ Specifications,
Fitness for Purpose
 
Precision (Dispersion of results in repeated
examinations)
Bias (Accuracy/ Comparability)
Linearity (AMR)
Analytical sensitivity,  LoB, LoD, LoQ
Analytical Specificity, interferences
Biological Reference Interval (BRI)
 
 
 
9/10/2024
 
Labs for Life Project - India
 
19
 
Which reagents?
 
 
For all reagents: Sensitivity, Specificity
 
Tests with numerical results: Deliberation on
Precision, Accuracy, Linearity, BRI
 
9/10/2024
 
Labs for Life Project - India
 
20
 
Precision
 
The agreement of the measurements of replicate
runs of the same sample.
It may be understood as the dispersion of
repeated measurements about the mean value.
Precision is measured in terms of coefficient of
variation (CV).
Most reagent manufacturers specify
repeatability (intra-assay/within-run precision)
intermediate (inter-assay/between-run) precision.
This also will be specified for different clinical
decision levels.
 
9/10/2024
 
Labs for Life Project - India
 
21
 
An example….
 
9/10/2024
 
Labs for Life Project - India
 
22
 
Accuracy
 
 
Comparability: 
Accuracy or trueness is the
degree of closeness 
of measured values (using a
given method) to the true/correct value and
comparability of the method to the reference
method
Bias
 is a quantitative measure of the average
difference between results from a given
measurement procedure and results from an
accepted reference measurement procedure.
 
9/10/2024
 
Labs for Life Project - India
 
23
 
9/10/2024
 
Labs for Life Project - India
 
24
 
How is accuracy denoted on a kit
insert?
 
Method comparison
’ in the kit insert.
Data from Regression analysis (Correlation
Coefficient, Slope, and Intercept)
Data from Difference Calculations
 
 
9/10/2024
 
Labs for Life Project - India
 
25
 
Data from Regression analysis (Correlation
Coefficient, Slope, and Intercept)
 
The correlation coefficient denotes the
comparability and should be > 0.975%. The ideal
is 1.
The slope and the intercept denote the bias
from the reference methods.  The number of
samples compared and the measurement range
covered for comparison studies are also given.
 
9/10/2024
 
Labs for Life Project - India
 
26
 
9/10/2024
 
Labs for Life Project - India
 
27
 
Data from Difference Calculations
 
9/10/2024
 
Labs for Life Project - India
 
28
 
Linearity
 
Analytical measurement range 
(AMR): 
Linearity is
the range of analyte values that a method can
directly measure on the specimen without any
dilution, concentration, or other pretreatment
not part of the usual assay process.
It indicates the consistency of imprecision and
accuracy (bias) over the range of measurement.
A higher range gives better advantage in analysis
 
9/10/2024
 
Labs for Life Project - India
 
29
 
An Example…
 
 
The Glucose procedure is linear from 10 - 800 mg/dL for
serum and cerebrospinal fluid determinations;
10 - 700 mg/dL for urine determinations. Samples
exceeding the upper limit of linearity should be diluted
and repeated. The sample may be diluted, repeated and
multiplied by the dilution factor automatically by
utilizing the AUTO REPEAT RUN.
 
 
9/10/2024
 
Labs for Life Project - India
 
30
 
Analytical Sensitivity
 
It is defined as the lowest
concentration of an
analyte/ substance that can
be distinguished from
background noise.
Limit of Blank (LoB)
Limit of Detection (LoD)
Limit of Quantitation
 
9/10/2024
 
Labs for Life Project - India
 
31
 
Analytical Specificity
 
 It is the ability of an assay procedure to
determine the concentration of a target analyte
without influence from other (potentially
interfering) substances or factors in the sample
matrix.
Includes:
cross reactivity
Interference
Endogenous
Exogenous
 
9/10/2024
 
Labs for Life Project - India
 
32
 
Cross reactivity
 
Cross Reactivity: 
refers to the erroneous
recognition of antigenically similar substances
e.g. genetically related microorganisms, cross
reacting antibodies/ antigens, etc
 
 
9/10/2024
 
Labs for Life Project - India
 
33
 
Interference
 
Interference
 is an artefactual increase or decrease in the
apparent quantity of an analyte due to the presence of a
substance that reacts nonspecifically with the measuring
system.
Endogenous interferences 
include hemolysis
(hemoglobin), icterus (bilirubin), lipemia, medications,
binding proteins
Exogenous interferences
 are caused by the
introduction of external factors or conditions not
normally present in native, properly collected and
stored samples e.g. blood collection tube additives,
serum separators.
 
9/10/2024
 
Labs for Life Project - India
 
34
 
Sensitivity Specificity 
an example..
 
9/10/2024
 
Labs for Life Project - India
 
35
 
Specificity, 
 
an example..
 
9/10/2024
 
Labs for Life Project - India
 
36
 
Biological Reference Intervals
 
When measurement of an analyte is performed
in a group of well-defined reference individuals,
the central 95% interval of results obtained is
referred to as the Biological Reference Interval for
that analyte.
It is frequently provided as the interpretive
information along with laboratory test results.
It may vary for different demographic samples
according to genetic and environmental factors.
 
9/10/2024
 
Labs for Life Project - India
 
37
 
Deciding on which reagent to purchase
Quality requirements, Fitness for
Purpose
 
Comparing the Stated Claims against
Acceptable Error Specifications
 
9/10/2024
 
Labs for Life Project - India
 
38
 
Acceptable error – where to look ?
 
Published literature – documented quality
specifications for the test e.g. BV database
Guidelines by international/national experts/
groups
Regulations e.g. CLIA
EQA/PT schemes: They recommend
acceptable error based on participant
provided data
Professional judgment
 
9/10/2024
 
Labs for Life Project - India
 
39
 
Milan Mandate 2015
 
Gives a hierarchy of sources to set performance
goals
a)
Goals based on analytical performance
related to Clinical Outcomes
b)
Goals based on Biological Variation
c)
Goals based on everything else e.g. Expert
group opinions/ guidelines, EQA/PT goals
 
9/10/2024
 
Labs for Life Project - India
 
40
 
Some resources
(online databases)
 
Biological Variation database
CLIA requirements for analytical quality
RCPA (Royal College of Pathologists of
Australasia)
French/Belgian EQA performance
specifications
European biologic goals
RiliBAK (Guidelines of the German Federal
Medical Council)
 
9/10/2024
 
Labs for Life Project - India
 
41
 
Comparing Manufacturers’ statements
 
9/10/2024
 
Labs for Life Project - India
 
42
 
Comparing Manufacturers’ statements
 
9/10/2024
 
Labs for Life Project - India
 
43
 
UNDERSTANDING QUALITY REQUIREMENTS
Desirable Biological Variation Database specifications
 
 
9/10/2024
 
Labs for Life Project - India
 
44
 
UNDERSTANDING QUALITY REQUIREMENTS
PUBLISHED SOURCES
 
9/10/2024
 
Labs for Life Project - India
 
45
 
Develop Checklists, assess
 
9/10/2024
 
Labs for Life Project - India
 
46
 
Understanding how to include Commercial
aspects
 
9/10/2024
 
Labs for Life Project - India
 
47
 
Extras that you can include into the
process:
 
Post-purchase verification process
Quality assurance through acceptance testing
Application support
Complaint resolution mechanisms
Review of agreement
Supplier track record evaluation
 
9/10/2024
 
Labs for Life Project - India
 
48
 
Writing Technical Specifications
Correctly, to your advantage
 
Writing Technical Specifications thus includes:
 
1.
Quality Specifications
2.
Operational Specifications
3.
Commercial Specifications
 
9/10/2024
 
Labs for Life Project - India
 
49
 
Two bid systems
 
The procurement of reagents and
consumables generally follows a two-bid
system where tenders are invited in two parts
Technical Bid
Price/ Financial Bid
 
9/10/2024
 
Labs for Life Project - India
 
50
 
Tips…
 
Maintain transparency
Be objective: minimize extraneous undue
influences on the process
Ensure reliability of suppliers, in terms of
quality and service
Conclude the process within the shortest
possible time span
 
9/10/2024
 
Labs for Life Project - India
 
51
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Effective inventory and quality management are crucial in laboratories to maintain workflow efficiency and prevent errors. Monitoring the quality of inventory flow, ensuring sufficient supplies, and procuring quality materials are key factors in maintaining a high standard of laboratory services. Quality controls and proper procurement procedures play a vital role in providing accurate diagnostic test results. Understanding the utility and feasibility of new tests, considering clinical needs and cost-effectiveness, is essential for operational success.


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  1. Quality System Essential: Inventory Management Quality Management of Laboratory Material ISO 15189: 2012 9/10/2024 Labs for Life Project - India 1

  2. Inventory management Quantity Management Ensuring the quantity of supplies as required so as ensure smooth workflow Serves to prevent stock outs and maintain turnaround times (TAT) 9/10/2024 Labs for Life Project - India 2

  3. Quality management WHY ? Reliable monitoring the quality of its inventory flow Ensuring quality of material is an integral part of quality assurance in the laboratory The primary error prevention step: Quality Reagents diagnostic services require 9/10/2024 Labs for Life Project - India 3

  4. Quality Controls (IQC/EQA) used for monitoring of the precision/accuracy of analytical system, are dependent on supply of quality reagents Checking the quality of reagents and consumables before procuring/using them Important interfering variable in the final patient report 9/10/2024 Labs for Life Project - India 4

  5. Quality Management HOW ? Selection and procurement of diagnostic laboratory materials is challenging given the Wide choice of products and suppliers Procurement policies prevalent in the system A series of steps must be followed to ensure the quality of materials used in the laboratory 9/10/2024 Labs for Life Project - India 5

  6. Quality Management Introducing a new method/ Retendering for an existing test For tests already in use 9/10/2024 Labs for Life Project - India 6

  7. Understanding Utility and Feasibility 9/10/2024 Labs for Life Project - India 7

  8. Understanding requirements for the NEW test: Initial thoughts Clinical utility Understand the needs of patients and users Understand the performance of a test Feasibility Test demand Cost effectiveness Operationalizing 9/10/2024 Labs for Life Project - India 8

  9. Clinical utility (Need and Performance) Discovery of novel biomarkers e.g. Lp(a), homocysteine Change in disease trends e.g. Swine flu Recent advances in assay methods e.g. Immunoassay, quantitative Trop I Different testing objectives e.g. screening, confirmatory, treatment monitoring, surveillance etc Relevance: diagnostic sensitivity & specificity, positive & negative predictive values (Literature, guidelines, pilot studies) 9/10/2024 Labs for Life Project - India 9

  10. Feasibility Cost inputs Reagents Quality controls Proficiency testing Calibrators Equipment Cost cutting Improved TAT Better performance Improved safety 9/10/2024 Labs for Life Project - India 10

  11. Survey the market for products 9/10/2024 Labs for Life Project - India 11

  12. Market survey Researching the available test options by interacting with the vendors Different product kit inserts should be consulted to understand the differences in performance characteristics of the various kits 9/10/2024 Labs for Life Project - India 12

  13. Understand Operationalizing Requirements 9/10/2024 Labs for Life Project - India 13

  14. Challenges in Operationalizing Test complexity Compatibility with current equipment/ infrastructure/LIS Staffing/training requirements Space/ Open system/ Closed system IQC/EQA requirements/ availability Type and quantity of sample required Patient/sample preparation required Pre-analytical acceptance criteria and possible errors Sample storage criteria 9/10/2024 Labs for Life Project - India 14

  15. Initial thoughts.. Gathering Evidence Ensuring quality of the manufacturing process 9/10/2024 Labs for Life Project - India 15

  16. Ensuring quality of the manufacturing process The specification may request products that have been approved by national and international regulatory agencies e.g. FDA, CE, WHO etc. 9/10/2024 Labs for Life Project - India 16

  17. Understanding Performance Specifications stated by manufacturers 9/10/2024 Labs for Life Project - India 17

  18. Quality requirements, Fitness for Purpose All laboratory measurements carry some uncertainty/error Different testing objectives e.g. screening, confirmatory, treatment monitoring, surveillance etc. Lab must decide the level of error which could be acceptable/ allowable: Quality Specifications 9/10/2024 Labs for Life Project - India 18

  19. Quality requirements/ Specifications, Fitness for Purpose Precision (Dispersion of results in repeated examinations) Bias (Accuracy/ Comparability) Linearity (AMR) Analytical sensitivity, LoB, LoD, LoQ Analytical Specificity, interferences Biological Reference Interval (BRI) 9/10/2024 Labs for Life Project - India 19

  20. Which reagents? For all reagents: Sensitivity, Specificity Tests with numerical results: Deliberation on Precision, Accuracy, Linearity, BRI 9/10/2024 Labs for Life Project - India 20

  21. Precision The agreement of the measurements of replicate runs of the same sample. It may be understood as the dispersion of repeated measurements about the mean value. Precision is measured in terms of coefficient of variation (CV). Most reagent manufacturers specify repeatability (intra-assay/within-run precision) intermediate (inter-assay/between-run) precision. This also will be specified for different clinical decision levels. 9/10/2024 Labs for Life Project - India 21

  22. An example. The following data was obtained using the Glucose Reagent on XYZ analyzers according to established procedures. Results obtained in individual laboratories may differ. The within run precision for serum samples is less than 3%CV and total precision is less than 3%CV =100 Within run Total Mean, mg/dl SD CV% SD CV% 59.1 0.4 0.7 0.9 1.6 258.1 1 0.4 3.8 1.5 9/10/2024 Labs for Life Project - India 22

  23. Accuracy Comparability: Accuracy or trueness is the degree of closeness of measured values (using a given method) to the true/correct value and comparability of the method to the reference method Bias is a quantitative measure of the average difference between results from a given measurement procedure and results from an accepted reference measurement procedure. 9/10/2024 Labs for Life Project - India 23

  24. 9/10/2024 Labs for Life Project - India 24

  25. How is accuracy denoted on a kit insert? Method comparison in the kit insert. Data from Regression analysis (Correlation Coefficient, Slope, and Intercept) Data from Difference Calculations 9/10/2024 Labs for Life Project - India 25

  26. Data from Regression analysis (Correlation Coefficient, Slope, and Intercept) The correlation coefficient denotes the comparability and should be > 0.975%. The ideal is 1. The slope and the intercept denote the bias from the reference methods. The number of samples compared and the measurement range covered for comparison studies are also given. 9/10/2024 Labs for Life Project - India 26

  27. Method Comparison (Serum) Patient samples were used to compare this Glucose Reagent with a reference reagent. The table below demonstrates representative performance on XYZ analyzers. Y Method XYZ1 X Method XYZ2 Slope 0.986 Intercept 0.4 1.000 Correlation Coefficient (r) No. of Samples (n) 180 Range (mg/dL) 10-644 9/10/2024 Labs for Life Project - India 27

  28. Data from Difference Calculations 9/10/2024 Labs for Life Project - India 28

  29. Linearity Analytical measurement range (AMR): Linearity is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment not part of the usual assay process. It indicates the consistency of imprecision and accuracy (bias) over the range of measurement. A higher range gives better advantage in analysis 9/10/2024 Labs for Life Project - India 29

  30. An Example The Glucose procedure is linear from 10 - 800 mg/dL for serum and cerebrospinal fluid determinations; 10 - 700 mg/dL for urine determinations. Samples exceeding the upper limit of linearity should be diluted and repeated. The sample may be diluted, repeated and multiplied by the dilution factor automatically by utilizing the AUTO REPEAT RUN. 9/10/2024 Labs for Life Project - India 30

  31. Analytical Sensitivity It is defined as the lowest concentration of an analyte/ substance that can be distinguished from background noise. Limit of Blank (LoB) Limit of Detection (LoD) Limit of Quantitation 9/10/2024 Labs for Life Project - India 31

  32. Analytical Specificity It is the ability of an assay procedure to determine the concentration of a target analyte without influence from other (potentially interfering) substances or factors in the sample matrix. Includes: cross reactivity Interference Endogenous Exogenous 9/10/2024 Labs for Life Project - India 32

  33. Cross reactivity Cross Reactivity: refers to the erroneous recognition of antigenically similar substances e.g. genetically related microorganisms, cross reacting antibodies/ antigens, etc 9/10/2024 Labs for Life Project - India 33

  34. Interference Interference is an artefactual increase or decrease in the apparent quantity of an analyte due to the presence of a substance that reacts nonspecifically with the measuring system. Endogenous interferences include hemolysis (hemoglobin), icterus (bilirubin), lipemia, medications, binding proteins Exogenous interferences are caused by the introduction of external factors or conditions not normally present in native, properly collected and stored samples e.g. blood collection tube additives, serum separators. 9/10/2024 Labs for Life Project - India 34

  35. Sensitivity Specificity an example.. 9/10/2024 Labs for Life Project - India 35

  36. Specificity, an example.. 9/10/2024 Labs for Life Project - India 36

  37. Biological Reference Intervals When measurement of an analyte is performed in a group of well-defined reference individuals, the central 95% interval of results obtained is referred to as the Biological Reference Interval for that analyte. It is frequently provided as the interpretive information along with laboratory test results. It may vary for different demographic samples according to genetic and environmental factors. 9/10/2024 Labs for Life Project - India 37

  38. Deciding on which reagent to purchase Quality requirements, Fitness for Purpose Comparing the Stated Claims against Acceptable Error Specifications 9/10/2024 Labs for Life Project - India 38

  39. Acceptable error where to look ? Published literature documented quality specifications for the test e.g. BV database Guidelines by international/national experts/ groups Regulations e.g. CLIA EQA/PT schemes: acceptable error based provided data Professional judgment They recommend participant on 9/10/2024 Labs for Life Project - India 39

  40. Milan Mandate 2015 Gives a hierarchy of sources to set performance goals a) Goals based on analytical performance related to Clinical Outcomes b) Goals based on Biological Variation c) Goals based on everything else e.g. Expert group opinions/ guidelines, EQA/PT goals 9/10/2024 Labs for Life Project - India 40

  41. Some resources (online databases) Biological Variation database CLIA requirements for analytical quality RCPA (Royal College of Pathologists of Australasia) French/Belgian EQA performance specifications European biologic goals RiliBAK (Guidelines of the German Federal Medical Council) 9/10/2024 Labs for Life Project - India 41

  42. Comparing Manufacturers statements Manufacturer A Manufacturer B 9/10/2024 Labs for Life Project - India 42

  43. Comparing Manufacturers statements 9/10/2024 Labs for Life Project - India 43

  44. UNDERSTANDING QUALITY REQUIREMENTS Desirable Biological Variation Database specifications CVI= within-subject biologic variation CVG= between-subject biologic variation I = desirable specification for imprecision B = desirable specification for inaccuracy TE = desirable specification for allowable total error 9/10/2024 Labs for Life Project - India 44

  45. UNDERSTANDING QUALITY REQUIREMENTS PUBLISHED SOURCES LoQ of different TSH assay methods Functional sensitivity (LoQ) 1.0-2.0 U/L Inter-assay CV TSH assay 1st generation <20% 2nd generation <20% 0.1-0.2 U/L 3rd generation <20% 0.01-0.02 U/L 4th generation <20% 0.001-0.002 U/L 9/10/2024 Labs for Life Project - India 45

  46. Develop Checklists, assess Bran d FDA /CE/ Other approvals Precision Accuracy Linear ity Sensiti vity Specific ity Scor e MD P 1 MDP 2 r Slope Inte %Bia s rcep t X Y Z 9/10/2024 Labs for Life Project - India 46

  47. Understanding how to include Commercial aspects 9/10/2024 Labs for Life Project - India 47

  48. Extras that you can include into the process: Post-purchase verification process Quality assurance through acceptance testing Application support Complaint resolution mechanisms Review of agreement Supplier track record evaluation 9/10/2024 Labs for Life Project - India 48

  49. Writing Technical Specifications Correctly, to your advantage Writing Technical Specifications thus includes: 1. Quality Specifications 2. Operational Specifications 3. Commercial Specifications 9/10/2024 Labs for Life Project - India 49

  50. Two bid systems The procurement of reagents and consumables generally follows a two-bid system where tenders are invited in two parts Technical Bid Price/ Financial Bid 9/10/2024 Labs for Life Project - India 50

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