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Quality Assurance of Laboratory Results: A Challenge in Health Care

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DYPJHS Volume 1 Issue 1 : 11-15 Oct-Dec. 2013
D Y Patil Journal of Health Sciences
REVIEW
Quality Assurance of Laboratory Results: A Challenge in Health Care Management
Yadav KS*, Chakraborty B
Abstract
In health care clinical laboratories plays very important role in
diagnosis and prognosis of the disease. So clinical laboratories are
rapidly transforming into an efficient and extremely automated
fashion and its metamorphosis has been expensive. Due to cost
factor, unbiased report, emergency services and shortage of skilled
manpower, running such establishment is tedious task. Atomization
of clinical laboratories minimizes certain workstations but quality
delivery was lacunas before few decades. Quality control in clinical
laboratories may be practiced prospectively and provide information
about the acceptability of the most recent analytical run(s) or may be
practiced retrospectively and provide information about past
performance. The results of quality control evolved with the growing
use of the multitest analyzer within the early 1970s. Laboratory
managers gradually accomplished that the applying of ±2s quality-
control limits to multitest analyzer. As early as 1974, Haven
expanded the allowable deviations of quality-control results by
defining a run as out of control if either a single control observation
exceeded the ±3s limits or 2 observations exceeded the ±2s limits.
This approach was rationalized by Westgards investigations into the
efficiency and appropriateness of various laboratory quality- control
rules which describes of two control rules, one sensitive to
systematic error and the other sensitive to random error. Point-of-
care (POC) analyzers are more precise and accurate but daily
electronic quality control recommend. Laboratory professionals are
reluctant to change systems if they are perceived to be working
satisfactorily. The great emphasis on proficiency testing in CLIA 88
laboratory quality reports enhanced.
Conclusion: The quality-control procedure must be set up in the
laboratory; every laboratory must have IQC and EQC. Finally, every
laboratory professional should establish their own quality and
reference ranges and the entire laboratory staff technical and non-
technical must be trained periodically.
Key words: Quality control, Quality assurance, laboratory,
automation, Westgards and Haven's rational.
Introduction
State-of-the-art prospective quality-control systems entail the
use of medically relevant, analyte-specific internal control
limits. With analyte-specific limits broader than those
typically used in the clinical laboratory, there will be fewer
false rejections, fewer reporting reanalyzes, and shorter
delays in run reportage. If the analyst-specific limits are
Corresponding author - K.S. Yadav, E-mail: ksy_rahul@rediffmail.com
Departmnt of Biochemistry, Padmashree Dr. D Y Patil Medical College,
Padmashree Dr. D Y Patil University, Navi Mumbai - 400 706.
11
ISSN 2347-3665
narrower than those employed in the laboratory, a lot of errors
are detected, however the user is in danger of characteristic
errors over that s/he and so the manufacturer have little or no
control. Theutilization of various patient data quality-control
algorithms are portrayed conservatism is stressed in adopting
manufacturers' tips for surrogate, nondestructive quality-
control testing. A simple, optimized approach is
recommended in the systematic retrospective review of
proficiency knowledge. Finally, the associate degree
approach is bestowed for changing from older, antecedently
accepted quality control procedures to more efficient analyte-
specific quality control.
Today's clinical laboratory is rapidly transforming into an
efficient and extremely automated business, driven by many
factors along with the ever-decreasing compensation for
laboratory tests, the event of miniaturized instrumentation for
point-of-care applications, the consolidation of numerous
analytical functions into single workstations operated beneath
token supervising, networked laboratory and medical data
systems, the widely blind acceptance of directors for workers
reductions, the existence of many extremely economical and
competitive national reference laboratories, and conjointly
the formation of monumental, enormous competitive,
integrated health care delivery systems consisting of hospitals
and primary and specialty care clinics. The extraordinarily
competitive healthcare business has resulted among the
merging, downsizing, and elimination of laboratories.
This laboratory metamorphosis has been expensive in terms
of the dislocated and (or) unemployed technologist, person,
individual, someone, somebody, mortal, human, soul and
laboratory scientist. The transformation tends to reduce the
standard of services of every the clinical laboratory and so the
clinical laboratory industry. Table 1 shows the number of the
factors that enabled the transformation can doubtless
compromise laboratory quality. The nationwide drive to
reduce costs has resulted in large-scale replacement of
medical technologists by less-trained medical laboratory
technicians, increasing workloads, a reducing reliance on
general float and temporary personnel, and a reduction of
supporting technical personnel with the resulting de-
emphasis skill. The widespread trend of integration the high-
volume chemistry, hematology, and coagulation laboratory
into a core laboratory will compromise quality because the
pool of highly competent technologists is reduced. Even the
pathologist's role within the clinical laboratory continues to
diminish needs. Tissue pathology, the pathologist's primary
responsibility, needs a lot of attention because it'll increase in
complexes whereas its compensation remains constant or
decreases.
Table 1. Various causes of decreasing quality results in
hospital clinical laboratories.
l Hospital laboratory Mergers, Downsizing and
increased workload
l Medical laboratory technicians doing medical
technologists' work
l "Core" laboratories, Clinical laboratory industry
l Lack of training, technical specialists, Staffing by
floats, temporary workers
l Less mentoring, Less technical support
l Sinking customer-supplier relationship
In these highly competitive times, the laboratory is more
captivated with the laboratory industry than ever before. The
laboratory not only needs well-designed, efficient
instruments however conjointly need the manufacturer to
continually improve those assays already in use and to provide
robust, transferable reference intervals. Unfortunately, the
manufacturer has been experiencing the changes related to
downsizing and mergers longer than the clinical laboratory
and conjointly is also delivering but optimal help of its clinical
customer (Table 1). To complicate issues further, the
perceived have to be compelled to reduce prices has increased
the power of various purchasing groups, which in turn has
diminished the strength of concern between the clinical
laboratory client and therefore the clinical laboratory
manufacturer. Choices to accumulate instrumentation are
primarily based less on total quality and more on costs or
perhaps the procurance of additional instrumentation for other
laboratory disciplines.
Table 2 lists the clinical laboratory's determinants of high-
quality testing. When well-trained and motivated
technologists use high quality assays per standard operating
procedures, the end result's usually extremely accurate and
precise testing. Unacceptable results are typically produced
even by the simplest systems, procedures must be devised to
12
detect and correct the error state of affairs and amend any
erroneous patient results. This text deals with quality control
and therefore the detection and reduction of analytical error.
I inform the reader that the majority laboratory mistakes occur
not during the analytical section however before or after
testing. Ross and backwoodsman [1] reviewed 363 incidents
that occurred in a very tertiary-care hospital in 1987, within
the 337 medical records reviewed, pre-analytical errors were
un- noticed or misinterpreted, incorrect laboratory orders
were placed, patient preparation was not up to the mark,
patient identity was mistaken, wrong specimen
instrumentation, and illegal or mishandled specimens and
post-analytical are delayed, untouchable, or incomplete
results mistakes are accounted for forty sixth and forty
seventh of the whole incidents, severally. Non-laboratory
personnel were accountable for twenty ninth of the mistakes.
Table 2. Parameter which enhances Laboratory quality testing
l Well-trained, motivated technologists, positive
mentorship
l High-quality assays from laboratory industry
l Standard operating procedures
l Adequate Internal quality External control assessment
l Unbiased administration, task force approach towards
patients.
Intense spirit of quality improvement
Quality control may be defined as the control of the testing
process to ensure that test results meet their quality
requirements [2,3] . Quality control may be practiced
prospectively and provide information about the acceptability
of the most recent analytical run(s) or may be practiced
retrospectively and provide information about past
performance. Prospective quality control can involve the
statistical analysis of reference samples, the review of patient
data, and even instrument-based electronic checks.
Retrospective quality control includes external quality
assessment or proficiency testing, the use of summary quality-
control data provided by a regional or manufacturer-supplied
quality-control program, calibration checking of unlike
analyzers, and even the follow-up of clinician inquiries.
Authentication rule, Westgards and Haven's rational:
± 2SD to ±3SD
The results of quality control evolved with the growing use of
the multitest analyzer within the early 1970s. Laboratory
managers gradually accomplished that the applying of ±2s
quality- control limits to multitest analyzer quality-control
data resulted in several falsely out-of-control events. When
the specimens in the out-of-control run were reanalyzed, the
analyst often discovered lowest variations between the
original and repeat determinations. As early as 1974, Haven[4]
expanded the allowable deviations of quality- control results
by defining a run as out of control if either a single control
observation exceeded the ±3s limits (a violation of the 13s
control rule) or 2 observations exceeded the ±2s limits (a
violation of the 22s control rule). This approach was
rationalized by Westgards investigations into the efficiency
and appropriateness of various laboratory quality-control
rules. In two seminal papers[5, 6], he introduced a language for
quality-control rules and procedures and used computer
simulations to calculate two probabilities of detecting the
error: the probability of false rejection and the probability of
error detection.
Westgard showed that quality-control procedures should
sometimes consist of two control rules, one sensitive to
systematic error and the other sensitive to random error. In a
subsequent paper he delineated a quality-control procedure[7]
consisting of a rule that screened for observations outside the
±2SD control limits and 2 rules that detected the occurrence of
random error and three rules that detected a systematic error.
This multirule combination, now noted as the Westgard
multirule procedure, is available on virtually all laboratory
information systems (LIS) and microcomputer-based
chemistry analyzers.
Westgard et al soon accomplished that quality control should
be specified by the instrument or even by analyte. The
application of the six-rule multirule procedure to highly
precise analyses cared-for detects tiny, sometimes
insignificant analytical error. Westgard used these most
systematic and random errors and therefore the power operate
diagrams to construct quality-control choice grids[8]. These
grids permitted the selection of better quality-control rules for
various amounts of tolerable error and error frequency.
Westgard is currently marketing a computer program[9] that
allows the user to specify associate degree analyte, it's
imprecision.
The laboratory technologist is a lot of actuated to use the
optimized quality-control procedure if it reduces the
frequency of quality control. Koch et al.[10] showed that the
application of optimized analyte-specific quality-control
practices reduced the frequency of falsely rejected runs,
reduced quality-control expenses and exaggerated the
efficiency of their high-volume chemistry analyzer.
13
The laboratory technologist is much less actuated to use the
optimized quality-control procedure if it will increase the
frequency of quality-control testing or detects a lot of
occurrences of analytical error. Such optimized quality-
control systems find issues with that the manufacturer might
not be able to facilitate, so inflicting a lot of issues in
convincing directors and technologists of the another price of
a lot of sensitive procedures. It is going to be more practical to
change or maybe replace the analytical procedure for another
stable and requiring less sensitive internal control.
Although the averages of patient clinical chemistry data were
originally described for quality control over thirty years
ago[11], a series of investigators found that the technique lacked
the error-detection capabilities of reference sample quality
control. The error-detection capabilities of patient averages
depend on multiple factors[19] with the most important being
the number of patient results averaged (Np) and therefore the
ratio of the standard deviation of the patient population (sp) to
the standard deviation of the analytical technique (sa).
Point-of-Care Quality-Control Practices
Glucose reflectance meters represent one of the first of point-
of-care devices to be introduced into hospitals. Quality-
control programs for point-of-care testing can thus be
patterned after those for whole-blood glucose testing. Kiechle
and I[12] provided a model for whole- blood glucose testing
includes: (a) two levels of quality control for each shift;
(b) one fasting laboratory correlation per operator per day
within +15% of the laboratory value; (c) meter results <500
mg/L verified by laboratory glucose determination;
(d) proficiency testing once in three month; (e) all
technologist trained to receive initial authorization; and
(f) annual skills validation or reauthorization.
Because many point-of-care analyzers are more precise
and accurate than whole-blood glucose meters, their
manufacturers recommend daily electronic quality control.
Most point-of-care analyzers are relatively new, and their
evaluations have been short-term and performed under ideal
conditions. The error-detection capabilities of a point-of-care
analyzers are not well characterized. For each point-of-care
analyzer, laboratory administrator must compile a database of
instrument malfunctions, error indicators, and the results of
running the electronic control and reference specimens before
installation.
IQC and EQC: Quality certification of reports
Because of the great emphasis on proficiency testing in
CLIA 88 [13, 14], laboratory technologist has to assure successful
proficiency testing. Although more effort recommended for
reducing pre-analytical and analytical variation and post-
analytical reporting errors, and thus decreasing the
probability of unsuccessful performance, little is expended in
interpreting proficiency results to determine the existence of
potentially correctable error conditions. The review of so few
results provides relatively little information about the
acceptability of an analytical run and about the presence of
substantial random or systematic error. Under CLIA 88, for
more information about systematic and random error is
provided.
Cembrowski et al.[15] have proposed a multirule system
(Table 3) to evaluate the HCFA-mandated proficiency test
results: (a) a screening rule; (b) a rule for the detection of
systematic error; and (c) two rules for the detection of random
error. The rules are used multiples of the standard deviation
index (SDI) which is calculated from: SDI = (laboratory value
– group mean) /group standard deviation.
Table 3. Multirule system to evaluate the proficiency testing
results
No. Rule Status of run value Cause/s of rule violation
1 Screening Outside +1 SDI limit or Systematic and
rule: –1 SDI limit random error
2/51sdi
2 Mean rule: Outside 1.5 SDI or is Systematic error
x1.5sdi less than –1.5 SDI
3 13sdi rule Outside +3SDI or the Random error
–3SDI
4 r4sdi rule Difference between the
largest and the smallest Random error
proficiency testing
result exceeds 4SDI
Because of the high specificity of the follow-up rules, their
violation should be followed by a review of the laboratory
records including the internal quality-control results.
The multi-rule system for inspecting proficiency testing data
is simple and easy to adopt. Its use results in a uniform style of
proficiency test evaluation by laboratory technologist. Many
reputed professionals adopted multi-rule approach [16].
Significant sources of both random and systematic errors have
been discovered and corrected by this technique. Many
proficiency test programs do not provide SDI summaries of
the participant's data. Lack of SDI summaries indicates that
14
the proficiency test provider is marketing a suboptimal
product.
Current Quality Control
Many quality control procedures have been proposed for the
clinical laboratory. In 1997, the 12s control rule appears to be
the most common single quality-control rule used for
analytical run rejection[17]. More than 20 years have passed
since Haven published his multirule approach and Westgard
started to develop the tools for designing more efficient
quality-control practices. In the 1994 survey of 505 College of
American Pathologists Q-Probe subscribers, Tetrault and
Steindel[17] documented great inter-laboratory variation in the
use of quality-control rules. About 25% of the clinical
chemistry laboratories used the complete six-rule Westgard
multi-rule; 20% used the Haven multi-rule, and another 15%
used a subset of the Westgard multi-rule.
In the survey, 30% of the respondents claimed to use analyte-
specific medical decision limits for quality control. Tetrault
and Steindel found, however, that the medical decision limits
used by the participants for quality control were often equal to
the usual statistical quality-control limits. The implication of
this finding is that many laboratory professionals do not
understand the concept of analyte-specific quality control.
Laboratory professionals are reluctant to change systems if
they are perceived to be working satisfactorily. A recent
survey of quality-control practices in over 370 US hospital
laboratories[18] indicates that 50% of the respondents believe
that their staff who make daily decisions about run reliability
and accuracy have at least an average understanding of
statistical process control rules; another 36% believe that their
staff have an above-average understanding; another 4% put
their staff in the "expert" category. Such high levels of
understanding imply a high satisfaction with their quality-
control knowledge and indirectly with their quality-control
systems.
Conclusions
Use of Westgard's quality-control selection grids[8] or else use
Westgards quality-control microcomputer program[9] or a related
manual[19] must be implemented for delivering quality results
and better health care. The quality-control procedure must be set
up in the analyzer software or LIS and tested. Finally, every
laboratory professional should establish their own quality
parameters and reference ranges and all of the laboratory staff
must be trained. Unfortunately, such conversions are major
undertakings in today's down-sized laboratory.
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