Ana-Maria Simundic [*] [1] Elizabeta Topić [1]

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Total Quality Management

Total Quality Management (TQM) is a specific approach to the art of management in a company that aims to provide its customers with products and services that fully meet their needs (1). Implementing TQM means introducing the quality management system, defining the quality policy and procedures which are essential quality assurance and quality control instruments. Successful implementing TQM also requires commitment and full participation by all employees in continuous quality improvement activities, by continuously improving effectiveness and reducing the errors, defects and waste. Though originally developed for the manufacturing sector, TQM is today generally acknowledged as a supreme management philosophy, implemented in many organizations, institutions and companies of various activities and nature. It has also been successfully implemented in many healthcare organizations and clinical laboratories. Key components of the TQM are:
  • top quality of the services and products which fully meets customer needs and expectations;
  • top management commitment in defining quality goals, balanced with organization potentials, as well as the definition and implementation of the tools for achieving and appraising those goals;
  • continuous improvement based on the indicators of key processes and activities;
  • rapid response to customer needs and customer-driven and process-oriented product development;
  • evidence-based decision making, based on the data derived from the continuous monitoring of processes and activities;
  • active participation of all staff through continuous education and training, and encouraging each member of the organization to take the responsibility for quality;
  • promotion of the open and cooperative environment by the top management;

Basic idea of the TQM philosophy is to detect and eliminate weak points of the system and processes, and size down the error rate by the risk assessment and risk reduction.


How to measure quality?

Taking into account everything that has just been said about the continuous monitoring and improvement of the system as a whole, it should be emphasized that the main goal is to achieve the maximum quality with minimum waste and minimal error rate. As of clinical laboratory, it means to offer a right patient, right service in the right moment; i.e. to provide the reliable result from the best available sample with appropriate interpretation and in the most cost-efficient way. The biggest challenge is how to measure your own performance and how to assess your performance compared to other laboratories. That is what quality indicators are used for. Quality indicators are measurable, objective, quantitative measures of key system elements performance (2,3). They indicate the extent up to which a certain system meets the needs and expectations of the customers. Every clinical laboratory accredited according to the current standard for medical laboratories (EN ISO 15189) shall systematically monitor and evaluate its quality indicators (4). Many organizations have been dealing with quality indicators: College of American Pathologists, Centers for Disease Control and Prevention, Institute for Quality in Laboratory Medicine, Joint Commission on Accreditation of Healthcare Organizations, Centers for Medicare & Medicaid Services, and others.
Quality indicators can either be measures of processes, outcomes or contribution of the laboratory to the patient care. They can indicate the quality of the key, strategic (organization and management), and support (external services and supplies, maintenance, environmental safety) processes (5,6). It is of utmost importance that quality indicators address all three key processes in the laboratory: preanalytical, analytical and postanalytical (7,8).
Depending on the size of the laboratory, workload and test volume, every laboratory can chose to monitor various number of quality indicators. Small laboratories usually monitor less whereas larger laboratories monitor more indicators. Number of indicators can change with time. Certain indicator should be monitored as long as it provides useful information on the system performance.
Besides for self-evaluation, quality indicators can also be used for benchmarking. Therefore, unique definition of quality indicators is needed for their broad applicability. Though some attempts have been made already (9), there are still no widely accepted unique definitions of the quality indicators, meaning that each and every laboratory can and should define its own indicators. Quality indicators should have clear and unambiguous definition and interpretation, whereas the ability to measure the indicator is a prerequisite for its successful implementation, reproducible application, monitoring and evaluation.
Quality indicators for key processes in clinical laboratories can assess preanalytical, analytical and postanalytical phases of laboratory activity.
Quality indicators for preanalytical laboratory activity can be:
  • erroneous request;
  • error in patient identification;
  • test order appropriateness;
  • inadequate sample (hemolytic, lypemic, clotted etc.);
  • missing sample (sample lost or not received)
  • needle stick injuries.
Quality indicators for analytical laboratory activity can be:
  • external quality assurance results;
  • internal quality control results;
  • imprecision;
  • inaccuracy;
  • total error.
Quality indicators for postanalytical laboratory activity can be:
  • number of tests completed, but not requested by the clinician;
  • number of tests not completed
  • reports with erroneous patient or physician data;
  • hard copies of reports given out
  • average time for critical results reporting
  • number of critical results successfully reported
  • reports exceeding TAT (10);
  • customer satisfaction (patients and clinical staff);
  • number of reports corrected or withdrawn;
  • LIS downtime episodes;
  • technical staff errors.
Besides key processes, strategic and support processes are also important for successful functioning of a laboratory. Those processes refer to the laboratory organization, communication, education, environmental safety, resolving of complaints and nonconformities, etc. All those activities have a substantial effect to the overall quality of laboratory processes. It is therefore also important to monitor some indicators of those strategic and support processes. Ricos et al. have recently published a comprehensive review on strategic and support processes in laboratory medicine (5). Authors have established three indicators for the strategic processes:
·         goals reached;
·         referred tests for;
·         projects carried out.
Ricos et al. have identified 12 indicators for the support processes. Some of those indicators are:
·         physician satisfaction;
·         patients satisfaction;
·         written complaints;
·         verbal complaints;
·         corrective maintenance of instruments;
·         non-conformities to providers;
·         evaluation of training (number of hours received/number of hours worked).
It is also possible to monitor some financial indicators as well as the indicators of laboratory effectiveness, such as (2):
·         efficiency (defined as the cost per test);
·         productivity (defined as the workload per staff member);
·         total number of working hours;
·         preventive maintenance cost (11);
·         number of clinical trials, number of accredited tests (11).
Though having quite different meanings, efficiency and effectiveness are often mistakenly used synonyms. Efficiency refers to resources (time and money) spent by a certain process, while effectiveness defines the extent to which a process or a product meets its purpose and fulfills customer needs. Efficiency is therefore a measure of productivity whereas the effectiveness is a measure of quality.

Definition and implementation of quality indicators

What may only in the beginning seem as an easy task, is the exact and precise definition of the indicator and its successful implementation. For successful implementation of a specific quality indicator, following issues should be clearly defined:
·         what do we want to measure?
·         can we collect the data?
·         how shall we collect and analyze the data?
·         who is going to keep records of data needed for the indicator?
·         reporting intervals;
·         acceptance limits for the indicator;
·         the meaning of one bad result for our system;
·         what are we going to do when quality indicators fall outside acceptance limits? Are corrective actions available?;
·         For how long are we going to monitor the indicator?
Laboratory turnaround time (TAT) is one good example for a quality indicator of the key laboratory process. Physicians and other clinical staff usually assess the quality of the laboratory service by the time needed to get test results, often assuming that faster is better (12). Though not universally applicable, TAT can have a direct effect on the request-to-diagnosis time (13), request-to-therapy time and therefore indirectly influence the emergency department discharge delays and the hospital length-of-stay (14,15). There is no unique definition of TAT. TAT can be defined according to test (potassium, Hb, glucose), priority (stat or routine) and patient population (outpatients, emergency department, intensive care unit). TAT can also be classified by the steps of the total testing process: test request, blood collection, patient and sample identification, transport, sample preparation and distribution, analysis, verification, authorization, reporting, interpretation and decision making (16,17). For a successful implementation of TAT as a quality indicator, laboratory should monitor TAT for several tests referring to the different types of laboratory service (electrolyte testing, cardiac markers, acid-base status, urine testing etc.). Choice of a certain measure of TAT also depends largely on the data availability and the possibility to easily record data and periodically produce reports. Due to the data accessibility, laboratory mostly defines TAT as receipt-to-report time. On the other hand, clinicians define TAT as the request-to-report time (12). Due to the implementation of hospital information systems which offer bidirect link of the laboratory and hospital departments via electronic test request forms and test reports, it recently became possible to monitor the extra-laboratory time.
TAT can be described using two measures (16):
  • Average completion time (minutes) expressed by median;
  • Outlier rate.
TAT should be continuously monitored and its trends analyzed. If TAT indicator falls outside the acceptance limits, detailed analysis should be carried out to identify potential causes and improvement opportunities. Since TAT depends on many extra- and intralaboratory factors, improvements should be introduced in all those phases. Some improvements already shown to be beneficial are: electronic test request system implementation, automated sample transport systems (pneumatic tube, robots etc.), sample type (plasma, serum separator tubes, whole blood), use of primary sample for analysis, barcode identification, total laboratory automation including repeats, dilutions, verifications etc. (18).
By monitoring TAT as one of key laboratory quality indicators and by introducing corrective actions when needed, laboratory shows its commitment to provide and deliver products and services of utmost quality that fully meets customer needs.

Problems in definition and implementation of quality indicators

It is not always easy to develop and implement a quality indicator. For example, if critical values reporting is to be implemented as a quality indicator, following should be clearly defined:
·         critical values list,
·         exact reporting procedure (to whom values are to be reported, when and who is responsible for reporting, who keeps record of what is reported?)
·         indicator description (formula) and how indicator shall be presented.
Critical values reporting can be defined as the ratio of successfully reported values in a total number of critical values. Critical values are well established; any value of a laboratory result that indicates a life threatening condition and calls for an immediate clinical action, is a critical value (19). It is however to be pointed out that a clinical significance of every laboratory test result is assessed by a laboratory professional, taking into account all relevant clinical data, previous test results, diagnosis, age, patient population, sample quality etc. Such evaluation is at least to a certain extent, based upon subjective feelings or intuition and therefore not completely exact and reproducible. Thus, criteria and the concept are not completely standardized nor comparable. Many other factors make the standardization of the indicator difficult. Namely, in attempt to define a critical values reporting success, several important questions arise: is it acceptable if we report the critical value to a nurse or any clinical staff member? should we report the value only to the clinician responsible for that patient? how fast should we report it? is it acceptable if we report a hypoglycemia to the clinician in two hours period? is every reported critical value a successfully reported value, disregarding the time frame within which it was reported? All those issues are essential to the exact and uniform definition of the indicator, making the interlaboratory comparison problematic. And lastly, an essential prerequisite for the successful implementation is a possibility to keep records on reported critical values, either using the laboratory information system or manually.
The importance of continuous monitoring and trend analysis of quality indicators has already been emphasized, as well as the concept of continuous system improvement. Accordingly, critical values reporting success rate should be continuously monitored and potential causes for failure analyzed. If quality goals are not met, following corrective actions can be implemented:
·         staff education
·         communication with clinical staff should be improved (pagers);
·         a staff member responsible for critical values reporting should be designated
·         electronic reminders or automated reporting systems should be introduced.
As already previously mentioned, choice and number of indicators monitored in a laboratory may vary. Indicator should be closely monitored after a corrective action was undertaken, in order to appraise the effect of the implemented changes. Indicator can be monitored either for a certain period of time or permanently, depending on its nature and what it refers to. After some major process redesign, a laboratory can even stop monitoring an indicator and introduce another one if proven to be more representative of the system performance.


Analytical part of the diagnostic laboratory processes is highly standardized and surely presents the negligible source of the total volume of laboratory errors (20,21). Majority of errors occur outside of the laboratory, in the preanalytical phase (22,23) which comprises the patient identification, sampling, sample handling and transport to the laboratory. That extralaboratory segment has the major potential for improvement. As previously pointed out, clearly defined and easily comparable quality indicators are needed in order to quantify defects and limitations of system segments as well as to register and continuously monitor improvements resulting from system redesign and corrective actions. With the information we read out of the quality indicators, we can analyze our own trends, conceive changes over time and rank our own position on the national and international level. Proficiency testing and interlaboratory comparison are well established for the external independent evaluation of analytical phase of laboratory processes. For some 20 years ago, there have also been some preanalytical and postanalytical external quality assurance programs. First such programs for preanalytical external quality assurance were launched in 1989 (Q-probes) and 1998 (Q-tracks) (24,25) by College of American Pathologists (CAP). Those programs refer to the issues of patient identification, sample quality and appropriateness, TAT, critical values reporting, corrected and withdrawn reports, test request errors and some other. Several years later, Spanish Society of Clinical Chemistry and Molecular Pathology has also launched a similar external quality assurance program for preanalytical phase of laboratory diagnostics (26). External quality assurance programs for postanalytical phase have also been widely introduced and run in several countries, such as Italy (27,28), Australia (29,30) and United Kingdom (31).
Contemporary laboratory medicine envisions a laboratory with high quality standards, laboratory based on knowledge, competences and skills; built on the philosophy of continuous improvement. Laboratory accreditation and implementation of the quality management system is inevitable. Such concept implies the existence of a reliable and independent external quality assurance system for all phases of laboratory processes, using evidence-based quality indicators. Eventually, every such step forward is for the patient benefit and for the satisfaction of all users of the laboratory services.


Potential conflict of interest
None declared


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