LABORATORY QA biometrics, magnetic stripes, optical

character recognition (OCR), smart

cards, and voice recognition devices.
PRE-ANALYTICAL
2. NONTECHNICAL: The problem of
The pre-analytic testing phase occurs first in patient misidentification cannot be
the laboratory process. This phase may include reduced without implementing
specimen handling issues that occur even prior nontechnical methods along with
to the time the specimen is received in the introduction of automated technology
laboratory. for patient identification. This includes
APPROPRIATE TEST ORDERING BY implementation by the organization of
PHYSICIANS policies and procedures in the
laboratory for patient identification per
1. Developing clear written procedures CLSI guidelines, training of medical
2. Regular training by and assessing of the professionals on guidelines and
skills of the health care professionals procedures for patient identification,
3. Automating functions for support and specimen labeling, and patient safety
executive operations measures; health care organizations
4. Monitoring quality indicators must follow the procedures which best
5. Improving communication among health help to reduce risk and to improve
care and laboratory professionals patient safety.
PATIENT-SPECIMEN IDENTIFICATION Specimen Collection, Transport, and
The in patients should be asked to state their: Processing

 Full name Specimen Integrity- The second most

 Address essential requirement to reduce laboratory
 Birthdate error during the pre-analytical phase is
specimen integrity. Specimen integrity depends
 Age and/or
on the number of processes performed, such
 Unique identification number
as specimen collection, maintenance of
The laboratory technician, nurse, or treating specimen physiology, transportation, and
physician must compare this information with processing.
that listed on the identification wristband that
The following steps will ensure specimen
must be worn by the patient (when applicable)
integrity:
and the test requisition form or computer-
generated labels for that patient. 1. The laboratory should formulate easily
understood policies for collecting,
Health care professionals should approach
handling, and transporting specimens.
the problem of patient misidentification via
The laboratory must enforce standard
the following methods:
operating procedures (SOPs) for
1. TECHNICAL: The introduction of phlebotomy, which include proper
automated systems for positive patient procedures for specimen collection;
identification and specimen labeling universal precautions to be taken during
strongly helps to prevent diagnostic and specimen collection; and disposal of
medication errors. This can be achieved syringes, needles, and other materials
by using traditional bar codes or by used during the specimen collection
using the more innovative methods of process.
radio frequency identification (RFID),
 2. Laboratories should have evidence-  Automated Analysis- Initially, when
based criteria for specimen acceptance laboratory directors introduced
that must be implemented for handling automated instruments into laboratories,
the specimens before testing to assure these instruments were used mostly to
the reliability of analytical results.11 perform the tests that were requested
Laboratories should develop a most frequently.
standardized flowchart to detect and to  Validation of Analytical Procedures-
appropriately treat hemolyzed, clotted, The laboratory must carry out validation
and insufficient specimen material. of all analytical procedures to establish
that the performance characteristics of
NOTE: Important errors can occur during the
the method(s) in question meet the
pre-analytic phase with specimen handling and
requirements for the intended analytical
identification. Therefore, the pre-analytical
application
phase must have rigorous control measures to
 Verification of Reportable Range: A
avoid unwittingly allowing problems or errors to
minimum of 5 specimens with known
travel further "downstream."
values that cover the reportable range
given in the kit insert should be
analyzed in triplicate to assess the
ANALYTICAL PHASE reportable range.
The second phase is the analytic phases. This  Verification of Precision: The
phase includes what is usually considered the precision of the process indicates the
"actual" laboratory testing or the diagnostic reproducibility of its results. Personnel
procedures, processes, and products that will also calculate precision to a clinically
ultimately provide results. acceptable level of variation to assure
that the method meets clinical needs
ANALYTICAL PROCESS QUALITY  Verification of Analytical Accuracy:
1. The participation of the laboratory in an Analytical accuracy indicates the
internal QC program and in external veracity of the result. A minimum of 20
quality assessment procedures does not patient specimens that span the entire
directly ensure that the results reported testing range but do not exceed
by the laboratory are accurate and measurement range are required to
precise. determine this variable.
2. Laboratories usually do not calculate the  Verification of Analytical Sensitivity:
allowable total errors for all tests In this procedure, one calculates the
performed on all analytes, although this lower detection limit.
would improve the diagnostic process.  Verification of Analytical
3. Different laboratory report reference Interferences: There is no approved
values are nonspecific for age, sex, and protocol for performing this task, to our
physiological conditions (such as knowledge. Most commonly, laboratory
pregnancy). professionals test for lipemia, hemolysis,
and elevated bilirubin levels, usually by
Quality Improvement in the Analytical adding interfering materials to determine
Phase whether doing so changes the results;
also, these professionals determine
- To improve the quality of the analytical
potential interferences that are specific
phase of testing, the following
to the test and methodology used.
processes must be streamlined:
 Verification of Reference Limits:
Laboratory professionals adopt
 reference limits based on manufacturer laboratory, is the quality goal. When ATE is
recommendations, reference laboratory low, the laboratory needs less stringent QC
recommendations, and the reference rules; when ATE is high, the laboratory needs
limits mentioned in published articles. more stringent QC rules.
Each laboratory must verify its own
PEER REVIEW
reference limits by testing specific
analytes in healthy populations. - Peer review is the most widely used
Quality of Examination Procedures method to determine diagnostic
accuracy and to prevent diagnostic
- The laboratory must establish a well- errors in testing involving microbiology
defined and well documented program and pathology specimens.
for assessing and evaluating its
POST-ANALYTIC PHASE
examination procedures.
The post-analytic phase is the final phase of
The quality assurance program that should be
the laboratory process. This phase culminates
followed in the laboratory has 2 components:
in the production of a final value, result, or in
1. Internal QC Program: The QC program the case of histology, a diagnostic pathology
that is enacted by the laboratory at its report.
own level to assess its daily
CRITICAL VALUES: TURNAROUND TIME;
performance. This program uses
AND STAT VS. ROUTINE TEST PRIORITIES
continual checks to ensure that the
established reliability of the work of the  TURNAROUND TIME – is defined
laboratory does not fluctuate and that as the reporting interval
reports have been validated before they  CRITICAL VALUE – is a test result
are released. It demonstrates not only that conveys life or death information
the precision of results but is also a and is defined for “out of range” test
checkpoint at which reagents, results that must be acted upon as
instruments, and the proficiency of soon as possible
laboratory personnel are assessed.  STAT TEST – is defined as quick
2. External Quality Assurance Program: turnaround time, generally an hour or
All the errors arising in the laboratory less from specimen receipt until test
related to the accuracy and precision of result reporting
the process of analysis cannot be  ROUTINE TEST – turnaround
detected merely by use of the IQC applies to specimens for patients
program. Dependence on only without immediate need for results.
intralaboratory statistics (as in IQC) can
lead to lack of awareness of gradual or
sudden changes in the test system, LESSON 2: UNDERSTANDING THE
changes that are not under the control CLASSIFICATION OF LABORATORY
of the laboratory. REAGENTS
Calculation of the Allowable Total Error Types of reagents
(ATE)
 Grignard Reagent
The ATE is an analytical quality requirement
 Tollens' Reagent
that sets a limit for the imprecision (random
 Fehling's Reagent
error) and bias (systematic error) that are
 Collins Reagent
tolerable in a single measurement or single test
result. Calculated ATE, as performed by the  Fenton's Reagent.
  Solvents  SYNTHESIS GRADE CHEMICALS:
 Catalyst The primary purpose of this involves
 Enzymes organic synthesis and preparative tasks.
 LAB GRADE CHEMICALS: These are
commonly called UNILAB, Laboratory
LABORATORY REAGENTS Reagent (LR Grade chemicals), or
Chemically Pure (CP). You can find
- A laboratory reagent can be described them in educational or teaching labs.
as a substance used to measure, Though their purity levels are high, the
detect, or create other substances precise impurity levels remain
during a chemical reaction conducted in anonymous.
laboratories. In other words, we can say  AR GRADE CHEMICALS: These are
that these are the substances added to used for high precision work. In this,
the laboratory tests to carry out a trace impurities are restricted to the
chemical reaction or to check whether lowest possible limits for high precision.
any reaction occurs or not. Such reagents get used mainly for
analytical applications, research, and
quality control. If such reagents meet
WHAT IS REAGENT GRADING? the specifications of the American
Chemical Society Committee on
- the grading system is used to show how
Analytical Reagents, it will be denoted
pure a substance is. High grades are
as AR (ACS).
provided to the purest chemicals. As the
 ACS GRADE CHEMICALS: These
level of impurities increases, the grades
begin to get low. These impurities can reagents either meet or exceed all the
be metal, water, or other chemicals. standards stated by the American
Chemical Society (ACS). Their purity
- Validated methods specify the grade of
levels are exceptionally high, and they
reagents to be used. It is important to
are used in every domain wherever
use specified grades; otherwise, errors
quality factor can’t be ignored. So you
can arise due to contamination from
can easily find them in drug, food, or
reagents themselves. On the other
medical applications because they have
hand, you can incur additional costs in
above 95% purity.
the analysis if you use a superior grade
 GENERAL REAGENT (GR) – These
of reagent when your analysis does not
are the reagent that meets or exceed
have such high purity requirements.
AR grade specifications.
 EXTRA PURE GRADE CHEMICALS:
These are – suitable for laboratory
HOW ARE REAGENTS GRADED?
accreditations and also work requiring
 TECHNICAL GRADE CHEMICALS: compliance with pharmacopoeial
You may know this as TG (Tech Grade) standard requirements.
or Commercial Grade. It is used for low-
grade applications like commercial or
industrial purposes. Due to the present
impurities, it isn’t utilized for drug, food,
or medicinal purposes. You can also
find it in qualitative testing.
 CHEMICALS BASED ON THEIR  RESIDUE GRADE SOLVENTS – These
APPLICATIONS. solvents suitable for pesticide residue
analysis.
 ELECTRONIC GRADE CHEMICALS: –
these have very stringent limits for
metallic impurities as required for use in
CONCLUSIONS
electronic component industry as such
as below ppt or ppb levels - Result precision is of utmost importance
 HPLC GRADE CHEMICALS: These in laboratory testing. The choice of the
include adequately pure ion-pair right grade of reagent is essential for the
reagents, solvents, and buffers used as application in hand, and it is also
the mobile phase of High-Performance important to use reagents from the
Liquid Chromatography (HPLC). same source for high precision of
 SPECTROSCOPY GRADE results. With the provided information on
CHEMICALS: Various compounds are reagent grading, you will be able to pick
gained through organic synthesis. the correct reagents and ensure the
Nuclear magnetic resonance quality of your testing.
spectroscopy is the technique used for
their structural analysis.
DIFFERENT TYPES OF PURE WATER FOR
THE LABORATORY
ACIDS ARE GRADED DIFFERENTLY. YOU
CAN SEE A FEW EXAMPLES OF IT.
 SUPRAPUR (E – MERCK) – These
have high purity grade acids having
metallic impurities in ppb range.
 ENVIRONMENTAL GRADE
(ANACHEMIA) – These include high
purity acids refined through sub- boiling
distillation
 ENVIRONMENTAL GRADE PLUS
Type 1 Water (Ultrapure Water)
(ANACHEMIA) – Here, you can find
acids that get produced by additional Type I grade water, also known as Ultrapure
distillation of environmental grade acids. Water, is the purest form of water to be
produced. It’s used for the most critical
applications and advanced analytical
PESTICIDE RESIDUE ANALYSIS
procedures.
APPLICATIONS
This includes:
 HR OMNI GRADE SOLVENTS (EMD) –
These have GC impurities below • Cell and Tissue Cultures
ppt/ppb levels as tested by ECD • Liquid Chromatography, including High
detection. Performance Liquid Chromatography
 NANO GRADE – These meet ACS (HPLC)
grade specifications. They are used for • Gas Chromatography
extraction and pre-concentration • Inductively Coupled Plasma Mass
applications. Spectrometry (ICP-MS)
• Molecular Biology
 - Type I can also be used in applications water' through to 'drinking water' and
that require Type II water. This is quite a provides a valuable, non-specific
common practice that can help to avoid indication of the level of ions in the
the generation of by-products during water.
applications.
THE RESISTIVITY OF WATER
Type 2 Water
- Reported as Mega-Ohms per centimeter
Type II water grade doesn’t have the same (MO-cm) at 25oC, resistivity is related
pureness of Type I, but still maintains high to conductivity: a high resistivity
levels of purity. It is a good feed water for equals a low conductivity. As such, it
clinical analyzers as the calcium build-up is also provides a measure of the
reduced with this water type. water's ionic content. Unlike
conductivity, resistivity is primarily used
It can also be used in applications such as:
in the assessment of ultrapure water.
• General Lab Practices
ORGANIC COMPOUND LEVELS IN WATER
• Microbiological Analysis and preparation
• Electrochemistry - Organic compounds can exist in water
• FAAS (Flame ) in numerous forms and so measuring
• General Spectrophotometry every single one individually is
- It can also be used as feed water for Type I impractical. Instead, the most useful
water production. indicator is considered to be the total
organic carbon (TOC) content of the
Type 3 Water (RO Water)
solution. This is measured via a process
- Type III grade water, also known as that oxidizes the organic compounds
RO water, is water produced through present and then quantifies the
the purification technology reverse oxidation products generated. TOC is as
osmosis. Of all the pure water types it close as we can currently get to a
has the lowest level of purity, but is 'universal indicator' for the presence of
typically the starting point for basic lab organic impurities.
applications, such as cleaning BIOLOGICAL CONTAMINATION OF WATER
glassware, heating baths or media
preparation. It can also be used as a - The presence of biological contaminants
feed water for Type I water production. such as bacteria and other
microorganisms is a common issue in
untreated water. Bacterial levels
HOW IS LABORATORY WATER PURITY
reported as colony forming units per
ASSESSED AND DEFINED?
milliliter (CFU/ml) are kept low via
filtration, UV treatment and sterilant
solutions.
THE CONDUCTIVITY OF WATER
THE PRESENCE OF COLLOIDS IN LAB
- Conductivity is reported as WATER
microSiemens per centimeter (µS/cm) at
25oC and is the reciprocal of resistivity - Suspended particles can cause water
and provides a measure of a fluid's turbidity (measured in Nephelometric
ability to conduct electrical current. Turbidity Units, NTU) and are therefore
Conductivity is typically used when filtered out of laboratory water as much
assessing water ranging from 'raw as possible. This colloidal material is
 defined as being less than 0.5 µm in AMERICAN SOCIETY FOR TESTING AND
size and may contain iron, silica, MATERIALS (ASTM)
aluminium or organic materials. The
Fouling Index (FI) is frequently used to - The ASTM uses D1193-06 and has four
estimate the potential of water to block grades of water (see table below).
filters under 0.45 µm filter conditions. - *Requires use of 0.2 μm membrane
filter; **Prepared by distillation;
BOARDS SETTING THE STANDARDS OF ***Requires the use of 0.45 μm
WATER PURITY membrane filter.

WATER QUALITY PARAMETERS FOR ASTM

Clinical and Laboratory Standards Institute TYPES
(CLSI) – formerly NCCLS
Parameter Type Type Type Type IV
- As of 2006, the CLSI has moved away I* II** III***
from the typical Type I, II and III Conductivity 0.056 1.0 0.25 5.0
designations, instead preferring to (μS/cm) at 25oC,
suggest that water be simply ‘fit for
max
purpose’, and only describes one grade
in significant detail: Clinical Reagent Resistivity (MΩ- 18.0 1.0 4.0 0.2
Laboratory Water. The CLSI has also cm) at 25oC, max
briefly outlined other grades in less pH at 25oC – – – 5.0–8.0
detail, such Special Reagent Water
TOC (μg/l), max 50 50 200 No limit
(SRW) and instrument feed water.
Sodium (μg/l), 1 5 10 50
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO) max
Silica (μg/l), max 3 3 500 No limit
Parameter Grade Grade Grade Chloride (μg/l), 1 5 10 50
1 2 3 max
pH value at 25 C –
o
– 5.0–7.0
Conductivity 0.1 1.0 5.0
(μS/cm) at 25oC, max
Oxidisable matter – 0.08 0.4
Oxygen content (mg/l),
max
Absorbance at 254 nm 0.001 0.01 –
and 1 cm optical path
length, absorbance
units, max.
Residue after – 1 2
evaporation on heating
at 110oC (mg/kg), max
Silica (SiO2) content 0.01 0.02 –
(mg/l), max