Quality Assurance of Laboratory Results: A Challenge

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The results of quality control evolved with the growing use of the multitest analyzer within the early 1970s. Laboratory managers gradually accomplished that the ...
DYPJHS Volume 1 Issue 1 : 11-15 Oct-Dec. 2013 D Y Patil Journal of Health Sciences

ISSN 2347-3665

REVIEW

Quality Assurance of Laboratory Results: A Challenge in Health Care Management Yadav KS*, Chakraborty B

Abstract

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 qualitycontrol 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 analytespecific quality control.

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 qualitycontrol 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-ofcare (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.

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.

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 nontechnical must be trained periodically. Key words: Quality control, Quality assurance, laboratory, automation, Westgards and Haven's rational.

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

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: [email protected] Departmnt of Biochemistry, Padmashree Dr. D Y Patil Medical College, Padmashree Dr. D Y Patil University, Navi Mumbai - 400 706.

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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.

supporting technical personnel with the resulting deemphasis skill. The widespread trend of integration the highvolume 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. Hospital laboratory Mergers, Downsizing and increased workload

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Medical laboratory technicians doing medical technologists' work

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Table 2. Parameter which enhances Laboratory quality testing

"Core" laboratories, Clinical laboratory industry

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Well-trained, motivated technologists, positive mentorship

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Lack of training, technical specialists, Staffing by floats, temporary workers

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Less mentoring, Less technical support

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Sinking customer-supplier relationship

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High-quality assays from laboratory industry

Standard operating procedures

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Adequate Internal quality External control assessment

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Unbiased administration, task force approach towards patients.

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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.

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 qualitycontrol data provided by a regional or manufacturer-supplied quality-control program, calibration checking of unlike analyzers, and even the follow-up of clinician inquiries.

Table 2 lists the clinical laboratory's determinants of highquality 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

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

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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.

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 qualitycontrol 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).

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.

Point-of-Care Quality-Control Practices Glucose reflectance meters represent one of the first of pointof-care devices to be introduced into hospitals. Qualitycontrol 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