Phlebotomy issues and quality improvement in results of laboratory testing

Laboratory testing is an integral part of the decision-making process, and results of laboratory testing often strongly influence medical diagnoses and therapies. There is a long history of quality requirements in laboratory medicine, which have mainly concerned the analytic phase of this process. Owing to the substantial advances in technology, laboratory automation and analytic quality, there is increasing evidence that further quality improvements should be targeted to extra-analytic phases of laboratory testing. Objective difficulties to monitor most of the preanalytic variables which lie outside the direct control or supervision of the laboratory personnel, such as phlebotomy, call for effective educational and preventive policies. Owing to high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training, there are several opportunities for making errors during phlebotomy, which mainly concern patient misidentification and collection of unsuitable specimens for testing due to unsuited venous accesses, venous stasis, inappropriate collection devices and containers. Improved standardization of phlebotomy techniques, along with operative guidelines dissemination, continuous education, certification, and training of health care professionals involved in blood drawing responsibilities would enhance the chance of obtaining specimens of consistent quality, with favorable revenues for the health care system and the patient's outcome.     

Appropriateness in programs for continuous quality improvement in clinical laboratories

BACKGROUND: External reviews and the accreditation of medical laboratories involve more than the mere assessment of conformance with standards for organisational processes. The new approaches to quality improvement suggest that, rather than using inspection to correct unusual errors, there should be more emphasis on improving the processes of health care to ensure that desired outcomes are produced. Appropriateness plays a key role in programs for quality improvement. METHODS: Appropriateness in laboratory medicine can be assessed, and improved, through the governance of the entire testing process. This begins with test selection, proceeds through valuable pre-, intra- and post-analytical procedures, and concludes by assuring the correct interpretation and utilization of laboratory information. RESULTS: The International Standard, specifically developed for medical laboratories (ISO 15189) recognizes the value of appropriate interpretation and advisory services, although it does not specify requirements for assessing appropriateness, requesting tests and interpreting results. The effectiveness of clinical laboratories can be assessed by using surrogate markers, which indicate physicians' satisfaction, and clinical audits. Effectiveness is also enhanced by stressing the importance of the technical and professional competence of evaluators. CONCLUSIONS: Inappropriate laboratory utilization unjustifiably increases health care costs, can harm patients and perpetuates the vision of laboratory testing as a commodity. Improvement in laboratory appropriateness can be achieved by seeking a better relationship with physicians and by stressing the role of laboratory specialists in providing clinical advice for the selection of laboratory tests, and the interpretation and utilization of their results, thus leading to more satisfactory clinical outcomes.     

Opportunities to improve quality in laboratory medicine

Modern laboratories offer cost-effective and precise analysis of specimens. Unfortunately, accurate laboratory tests still can result in bad outcomes because of errors in the pre- and postanalytic phases of testing. Important sources of error in the preanalytic phase include errors in test ordering, patient identification, specimen collection, transport, and accessioning. Errors in the postanalytic phase often relate to turn-around time, delivery of reports, or interpretation of results. This article focuses on the key opportunities for improvement in quality.     

Medical errors: impact on clinical laboratories and other critical areas

The Institute of Medicine (IOM) report (1999) stated that the prevalence of medical errors is high in today's health care system. Some specialties in health care are more risky than others. A varying blunder/error rate of 0.1–9.3% in clinical diagnostic laboratories has been reported in the literature. Many of these errors occur in the preanalytical and postanalytical phases of testing. It has been suggested that the errors occurring in clinical diagnostic laboratories are smaller in number than those occurring elsewhere in a hospital setting. However, given the quantum of laboratory tests used in health care, even this small rate may reflect a large number of errors. The surgical specialties, emergency rooms, and intensive care units have been previously identified as areas of risk for patient safety. Though the nature of work in these specialties and their interdependence on clinical diagnostic laboratories presents abundant opportunities for error-generating behavior, many of these errors may be preventable. Appropriate attention to system factors involved in these errors and designing intelligent system approaches may help control and eliminate many of these errors in health care.     

Patient safety and the preanalytic phase of testing.

The preanalytic phase of testing includes a variety of procedural steps and variables that affect the patient and the test results. During the preanalytic phase, the patient may be directly harmed or injured. Failures of technique during the preanalytic phase lead to incorrect laboratory results, which threaten the patient's health. This article highlights key problems in the preanalytic phase and offers plans to reduce the problems based on a review of the literature. The key problem areas include: order entry, patient identification, phlebotomy-induced suffering and injury, medical vampirism, and dangerously inaccurate test results caused by failures in preanalytic technique.     

Interpretative commenting: A tool for improving the laboratory-clinical interface

The clinical interpretation of laboratory results is an integral part of laboratory services. However, while many clinical laboratories provide comments of some form or other in their reports, this provision varies from one country to another, and between laboratories in a single country. Over the last decade, the focus on medical errors and patient safety has spread worldwide, involving all medical disciplines, including laboratory medicine. While available evidence demonstrates that in recent decades an impressive reduction has been achieved in the rates of analytical errors in clinical laboratories, the pre- and post-analytic phases of the testing cycle are still error prone and, even more dramatic, affected by errors that could translate into harm and adverse events for patients. Interest in post-analytic errors, in particular, has increased the identification of problems not only before and during the reporting of laboratory results, but also in the physician's reactions to the transmission of data, their interpretation, and the appropriate action to take for the patient. Therefore, greater efforts should be made to facilitate the review, interpretation and utilization of test results. The continuation and expansion of interpretative commenting, part of a broad strategy to improve the transmission and communication of laboratory results, appear to be favored by several factors, including the introduction of new and complex tests, clinical and regulatory guidelines, data on clinicians' satisfaction and the impact of interpretative comments on patient outcomes. The appropriate training and education of laboratory professionals is a fundamental component in assuring quality and safety of interpretative comments. Moreover, quality assurance programs and an appropriate clinical audit are required to evaluate and improve upon this activity.     

The laboratory and patient safety

Laboratory data are used extensively in patient care; consequently, laboratory errors have a tremendous impact on patient safety. Clinical laboratories were early leaders in efforts to minimize medical errors and improve patient safety. These efforts continue in many areas, including patient and specimen identification, laboratory result notification, and assistance in laboratory data interpretation. Emerging ideas on identifying and reducing laboratory errors, as well as specific strategies are reviewed and discussed with examples.     

Preanalytic indicators of laboratory performances and quality improvement of laboratory testing

Laboratory diagnosis is traditionally a three-part process that develops within the preanalytic, analytic and post-analytic phases. There is consolidated evidence that lack of standardization and monitoring of preanalytic variables, including procedures for patient identification, sample collection, handling and processing has an adverse influence on the reliability of test results, consuming valuable healthcare resources and compromising the patient's outcome. The preanalytic phase enfolds the greatest potential for quality improvement, once reliable strategies are identified and applied. A comprehensive quality program should outstrip the traditional confines of clinical laboratories, encompassing reliable monitoring policies of the state of quality across the entire process. Such an approach requires the adoption of a reliable global quality monitoring system based on a core set of broad, evidence-based preanalytic performance measures. The present article synthesizes current evidence on this topic, defining a tentative approach for implementation of a preanalytic quality monitoring system in clinical laboratories.     

The changing face of clinical laboratories.

Laboratory medicine has undergone a sea change, and medical laboratories must now adapt to, and meet new, customer-supplier needs springing from shifts in the patterns of disease prevalence, medical practice, and demographics. Managed care and other cost-containment processes have forced those involved in health care to cooperate to develop a full picture of patient care, and this has affected clinical laboratory objectives, the main focus now being on improvement in medical outcomes. More recently, the resource shortages in health care and results of cost/effectiveness analysis have demonstrated that the value of a laboratory test must be ascertained not only on the basis of its chemical or clinical performance characteristics, but also by its impact on patient management, the only true assessment of the quality of testing being quality of patient outcomes. The time is ripe for changing the vision of laboratory medicine, and some of the reasons for this are the availability of results in real-time, the introduction of more specific tests, and the trend to prevent diseases rather than cure them. The information from laboratory tests designed to evaluate biochemical or genetic risk and/or prognostic factors cannot be replaced either by physical examination and/or the assessment of symptoms. Today, the importance of laboratory scientists must be proven in three broad areas: a) guaranteeing the quality of tests, irrespective of where they are performed; b) improving the quality of the service; c) maximizing the impact of laboratory information on patient management.     

Governance of preanalytical variability: Travelling the right path to the bright side of the moon?

Medical errors can be traditionally clustered into 4 categories, which include errors of diagnosis, errors of treatment, errors of prevention, and an ‘other miscellaneous’ category. Owing to the volume and complexity of testing, and considering that laboratory error is defined as any defect from ordering tests to reporting results and appropriately interpreting and reacting on these, it is not surprising that mistakes in the total testing process occur with frequency, have connections to all four types of medical errors and represent a serious hazard for patient health. Throughout the laboratory diagnostics, preanalytical problems prevail. Moreover, the positive trends towards reduction of laboratory errors over the past decade, particularly those in the analytical phase, has little involved the preanalytical phase, which actually represents the most critical area to target. In particular, the high frequency of errors still attributable to processes external to the laboratory requires additional efforts for the governance of this mistreated phase of the total testing process, so that we can finally find the right path to progress from the dark to the bright side of the moon. As for any other type of medical errors, the most effective path to improvement is the implementation of a total quality management system, encompassing a multifaceted strategy for process and risk analysis, based on error prevention, detection, and management.     

Exploring the iceberg of errors in laboratory medicine

The last few decades have seen a significant decrease in the rates of analytical errors in clinical laboratories, and currently available evidence demonstrates that the pre- and post-analytical steps of the total testing process (TTP) are more error-prone than the analytical phase. In particular, most errors are identified in pre-pre-analytic and post-post analytic steps outside the walls of the laboratory, and beyond its control. However, in a patient-centered approach to the delivery of health care services, there is the need to investigate any possible defect in the total testing process that may have a negative impact on the patient. In fact, in the interests of patients, any direct or indirect negative consequence related to a laboratory test must be considered, irrespective of which step is involved and whether the error is caused by a laboratory professional (e.g., calibration or testing error) or by a non-laboratory operator (e.g., inappropriate test request, error in patient identification and/or blood collection). Data on diagnostic errors in primary care and in the emergency department setting demonstrate that inappropriate test requesting and incorrect interpretation account for a large percentage of total errors whatever the discipline involved, be it radiology, pathology or laboratory medicine. Patient misidentification and problems in communicating results, which affect the delivery of all diagnostic services, are widely recognized as the main goals for quality improvement. Therefore, some common problems affect diagnostic errors, although specific faults characterising errors in laboratory medicine should lead to preventive and corrective actions if evidence-based quality indicators are developed, implemented and monitored. The lesson we have learned is that each practice must examine its own total testing process to discover its weaknesses and identify appropriate remedies.     

Acute care testing. Blood gases and electrolytes at the point of care

The standard turnaround time for acute care laboratory testing in tertiary care institutions is typically less than 15 minutes for blood gas or electrolyte values. From a clinical perspective, however, the desirable turnaround time is more on the order of 5 minutes, and this is technically achievable. The 15-minute standard can be met with strategically located STAT laboratories. To achieve a turnaround time of 5 minutes, it is necessary to move the "laboratory" closer to the patient and to have more than one instrument available. This latter configuration is called near or bedside patient testing. Why the 5-minute standard is not used universally throughout the nation is probably related to differing perspectives on "cost" and "quality." As manufacturers, hospitals and laboratories address the issue of rapid turnaround time in acute care settings, the 5-minute standard may become more widespread. Direct costs have been decreasing as more manufacturers enter the market for acute care testing. The overall quality is also improving, not only in the engineering features built into the instruments, but also as nonlaboratory staff gain skill in performing the testing. As more sites implement POCT, standards and guidelines for managing testing outside of the laboratory are being established. Solutions to preanalytic problems are being developed and implemented. POCT testing for blood gases and electrolytes was once considered to lie in the future but is now commonplace and may one day become the standard of care.     

ISO 15189 Accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory I

AimMedical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence.MethodsInternational Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation.ResultsAccreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet.ConclusionPreparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has to concentrate on patient safety issues related to laboratory testing and should perform quality improvement projects.     

Analytic results of HIV-1 testing using blind proficiency testing.

The use of blind proficiency testing (PT) to examine analytic performance of human immunodeficiency virus type 1 (HIV-1) antibody testing. A total of 32 hospital, blood bank, public health, and commercial laboratories were included in this study. Test sera were introduced as clinical specimens for HIV-1 testing from private practitioners, group practices, clinics, and hospitals in Southern California. A total of 26 laboratories were located throughout California, with six laboratories located in six other states. Results from 306 enzyme immunoassay screening tests and 192 supplemental tests for HIV-1 were reported. Although one positive specimen was reported as indeterminate in almost 30% of results, screening and supplemental testing performances were excellent, with accuracy levels comparable to performance reported on open PT and performance evaluation surveys in the United States. The indeterminate results were attributed to the interpretive criteria used rather than to laboratory errors. Blind PT can be an important tool in improving the quality of total laboratory testing, the usefulness of laboratory results in patient care, and ultimately the health of the public.     

Application of a six sigma model to the evaluation of the analytical performance of serum enzyme assays and the design of a quality control strategy for these assays: A multicentre study

BackgroundSix medical testing laboratories at six different sites in China participated in this study. We applied a six sigma model for (a) the evaluation of the analytical performance of serum enzyme assays at each of the laboratories, (b) the design of individualized quality control programs and (c) the development of improvement measures for each of the assays, as appropriate.MethodsInternal quality control (IQC) and external quality assessment (EQA) data for selected serum enzyme assays were collected from each of the laboratories. Sigma values for these assays were calculated using coefficients of variation, bias, and total allowable error (TEa). Normalized sigma method decision charts were generated using these parameters. IQC design and improvement measures were defined using the Westgard sigma rules. The quality goal index (QGI) was used to assist with identification of deficiencies (bias problems, precision problems, or their combination) affecting the analytical performance of assays with sigma values <6.ResultsSigma values for the selected serum enzyme assays were significantly different at different levels of enzyme activity. Differences in assay quality in different laboratories were also seen, despite the use of identical testing instruments and reagents. Based on the six sigma data, individualized quality control programs were outlined for each assay with sigma <6 at each laboratory.ConclusionsIn multi-location laboratory systems, a six sigma model can evaluate the quality of the assays being performed, allowing management to design individualized IQC programs and strategies for continuous improvement as appropriate for each laboratory. This will improve patient care, especially for patients transferred between sites within multi-hospital systems.     

The EC4 register of European clinical chemists and EC4 activities

The freedom of movement of people and goods within the European Union (EU) has a large impact for the member states. Particularly within health care it is important to recognize, or if necessary obtain, an adequate level of the quality of profession and practice, so that citizens know that health care is offered in their country at a level comparable to other countries. The importance of recognition also applies to laboratory medicine. European Communities Confederation of Clinical Chemistry (EC4) is the organization of societies for clinical chemistry and laboratory medicine in the EU. In Europe, health care develops in the direction where patients are treated in a health care chain environment. In this chain, patients move quickly from primary health institutes to secondary and tertiary institutes, and vice versa. This situation involves many health care workers including several laboratories. Diagnosis and therapy are now 'core business' of health care. Medical laboratories play an essential role in this. The broad spectrum of medical laboratory investigations make consultancy of medical laboratory specialists ever more important. The quality of both professionals and laboratories, as well as continuity of laboratory data within and between laboratories, are of utmost importance.EC4 is active in giving support to attain such quality. In most countries, this is the case at present. EC4 plays a central role in the Coordination of Automatic Recognition of Equivalence of Standards (CARE), if such a level exists or is achieved. Such CARE is focussed at three levels, the profession, quality of laboratories and calibration of laboratory data. The EC4 Register of European Clinical Chemists is open for colleagues educated in (bio)chemistry, pharmacy, biology as well as medicine, and trained according to the EC4 Syllabus. Equivalence of standards has been granted to national training schemes of 13 European Union countries. Since its opening in 1998, the number of applicants is growing steadily and quickly, reaching 1225 in May 2001.EC4 has published essential criteria for quality systems of medical laboratories, which formed the basis for a ISO draft international standard regarding quality and competence of medical laboratories.EC4 stimulates projects like the Calibration 2000 project in the Netherlands which focus on continuity of laboratory data, within-as well as between-laboratories.     

Efficacy of clinical laboratory: Therapeutic TAT,safety, and medical errors

Health care services rely on continued technological advances and management of the operational systems for optimum reduction of medical errors. Significant gains in health care outcomes as indicated by recorded increases in life expectancies have been achieved due to the availability and application of technological advances for medical services. The inadequacies in the application of these systems for maximum benefit of the health care systems have however been the subject of recent publications dealing with patient safety and medical errors [1], [2], [3], [4]. Estimates by the Institute of Medicine (IOM) indicate that approximately 44,000–98,000 deaths occur each year as a consequence of inadequate safety and failure to prevent errors in the health care system. This puts medical errors in the top four leading causes of deaths per the IOM report. Other studies in the USA states of Colorado, Utah, and New York suggest that medical errors occur in 2–4% of hospitalizations. The paper by Raab et al. denoted a 6.7% discrepancy between original report and secondary case review, and 5% of the discrepancies have modest to significant effect on patient care [Raab SS, Grzybicki DM, Zarbo RJ, Meier FA, Geyer SJ, Jensen C. Anatomic pathology databases and patient safety. Arch Pathol Lab Med 2005;129:459–66]. This presentation focuses on the health care safety and medical errors relative to clinical laboratory. The impact of laboratory operations with resultant delays in test turn around times (TAT) and other laboratory errors on the health care services are presented. The role of governmental (US Department of Health and Human Services) and non-governmental regulatory agencies (CAP, AACC, IFCC, CLSI, etc) in mitigating these clinical laboratory errors is discussed. The use of payment system as a mechanism for improving the quality of laboratory services is also presented to illustrate the checks and balance systems aimed at reduction of medical errors. The presentation will conclude with the recommendation that majority of the clinical laboratory delays in turn around time and other errors can be prevented with appropriate analytical systems and operational processes under the overall guidance of the right regulatory agencies.     

Atorvastatin reduces plasminogen activator inhibitor-1 expression in adipose tissue of atherosclerotic rabbits

Considerable attention has been focused on definition and enhancement of the analytical quality in laboratory testing over the past decades. Advances in laboratory technology and computer informatics have allowed a major sense of confidence with the analytical phase and more efforts should now be focused on extra-analytical areas of improvement, that should further strengthen the link between cost effectiveness and clinical outcome. Deduction and implementation of common reference intervals, to be possibly shared by a regional network of clinical laboratories, appear so far a crucial step to increase efficiency and harmonization. With the experience gained from External Quality Control exercises and with the consensus of several contributory laboratories, this process is underway in Italy. Quality performances resulting from widespread implementation of common reference intervals and longitudinal comparison of patient's data, will allow clinical laboratories to accomplish with a major transferability, amplifying health benefits and meeting increasing health systems demand.     

The Henry Ford Production System: LEAN Process Redesign Improves Service in the Molecular Diagnostic Laboratory: A Paper from the 2008 William Beaumont Hospital Symposium on Molecular Pathology

Accurate and timely molecular test results play an important role in patient management; consequently, there is a customer expectation of short testing turnaround times. Baseline data analysis revealed that the greatest challenge to timely result generation occurred in the preanalytic phase of specimen collection and transport. Here, we describe our efforts to improve molecular testing turnaround times by focusing primarily on redesign of preanalytic processes using the principles of LEAN production. Our goal was to complete greater than 90% of the molecular tests in less than 3 days. The project required cooperation from different laboratory disciplines as well as individuals outside of the laboratory. The redesigned processes involved defining and standardizing the protocols and approaching blood and tissue specimens as analytes for molecular testing. The LEAN process resulted in fewer steps, approaching the ideal of a one-piece flow for specimens through collection/retrieval, transport, and different aspects of the testing process. The outcome of introducing the LEAN process has been a 44% reduction in molecular test turnaround time for tissue specimens, from an average of 2.7 to 1.5 days. In addition, extending LEAN work principles to the clinician suppliers has resulted in a markedly increased number of properly collected and shipped blood specimens (from 50 to 87%). These continuous quality improvements were accomplished by empowered workers in a blame-free environment and are now being sustained with minimal management involvement.Molecular diagnostic laboratories, just as for other areas of pathology, face challenges associated with increasing testing volumes, decreasing reimbursement, and maintaining and improving quality levels. Diagnostic accuracy is crucial in pathology; nucleic acid-based diagnostic test results are often important for subsequent therapeutic decision making. Accurate and timely molecular testing can add a great deal of value to total patient management. Specimen types such as peripheral blood, bone marrow aspirates, and formalin-fixed, paraffin-embedded (FFPE) tissue, are routinely evaluated using molecular techniques. For tissue-based nucleic acid assays to enter a clinical setting, nucleic acids must be obtainable through current practices of diagnostic pathology. This might involve dealing with individuals who are based at off-site locations, have different priorities, and often have very little understanding of molecular testing requirements. Finally, the isolation of nucleic acids from FFPE tissue, which makes it possible to bring molecular testing to surgical pathology, requires close collaboration between molecular and histology personnel. For accurate and reliable test results, FFPE tissue must be handled in a standardized fashion, similar to how blood and other body fluids are used in routine clinical assays. Furthermore, it is important for individuals doing molecular testing on blood samples collected at different locations to understand the factors outside of their laboratories or sphere of influence. All of these factors might require molecular laboratory personnel to collaborate and become intimately involved with the education of different customer and supplier groups involved in the preanalytic and sometimes postanalytic phases of the testing cycle. This way, roles and boundaries of responsibility pertaining to each group become well defined and the expertise of each group can be used in the most efficient way.Issues with the preanalytic phase of the testing cycle in particular are not unique to molecular laboratories. Other studies have shown that many laboratory errors occur during the preanalytic phase. These usually consist of all activities leading up to actual analysis of the specimen.^1,2,3 In 2006 Plebani⁴ reported that defects in specimen adequacy occurred most often, with more than 60% of preanalytic errors involving inadequate quantity or unacceptable quality of specimen. Causes of unacceptable quality included collection in the wrong container, improper collection procedure, and improper storage and transportation techniques. Preanalytic factors during collection, processing, and storage of blood specimens may affect DNA and RNA quality and their subsequent use as biomarkers.^5,6,7 In terms of FFPE tissues, factors such as fixation and storage can also affect quality of specimens,⁸ as can preanalytic tissue processing.⁹To streamline overall laboratory services at our institution a continuous quality improvement initiative was implemented in early 2006 as the Henry Ford Production System (HFPS).¹⁰ This approach to quality improvement was initially adopted in the various sections of the surgical pathology laboratory at Henry Ford Hospital but now is practiced as LEAN management by more than 500 anatomical and clinical pathology employees at Henry Ford Health System. The encompassing goal is to streamline work processes of the pathology department so they are analogous to manufacturing processes (in the creation of value in its work product). Therefore, our pathology laboratory benchmarked the continuous process improvement disciplines of the very successful Toyota LEAN Production System¹¹ as well as those of Henry Ford.¹² Our laboratory-based quality effort melded a cultural transformation of management''s role and the employees'' work approach to go beyond simple approaches of leaning out operations, with the aim of reducing commonly encountered defects and waste.^13,14 The chief focus of LEAN is a continuous effort to eliminate process defects and waste while improving practice efficiency.Baseline data analysis in our laboratory revealed that the greatest challenge for timely molecular test result generation was defects that occurred during the preanalytic phase of specimen collection and transport. We have defined defects to measure waste and reworked imperfections in product requirements including discrepancies in flow or deficiencies in specimen collection and processing resulting in a bottleneck. These defects caused work to be delayed, stopped, or returned to the sender, but once defects and waste were so defined, processes were modified and standardized in accordance with our own HFPS principles. Two types of specimens are currently used in the molecular laboratory: formalin-fixed, paraffin-embedded tissue, which is processed and archived in histology, and blood and bone marrow aspirate specimens, which are collected at Henry Ford Hospital, associated hospitals, and regional medical centers.In this study we share our experience with the participation of the molecular pathology laboratory in the Henry Ford Production System as a framework for implementation of LEAN process redesign. Through a blameless work environment and contributions from all workers, we undertook the process of eliminating non-value-added waste and standardizing the process of electronic test ordering, of reporting, and of specimen collection, triaging, and transport, all of which contributed to an increase in overall efficiency and greatly reduced testing turnaround times (TATs).     

ISO 15189 accreditation: Requirements for quality and competence of medical laboratories,experience of a laboratory II

ObjectivesOur laboratory was accredited for 531 tests according to ISO 15189 standard (ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories) in 2007. An ambitious and young group of laboratory personnel has spent efforts with commitment and dedication to complete the heavy work of preparation and passed through assessment with success. We herewith share our experience of the accreditation, the stages we have been through; our solutions to obstacles which we came across during the process.Design and methodsOur approaches to topics of environmental conditions, document management system (CentroDMS), use of the laboratory information system (CentroLIS), corrective/preventive actions and measurement uncertainty are summarized in this article.ResultsExperience of our laboratory in different areas of ISO 15189 accreditation is presented in summary.ConclusionAccreditation of medical laboratories increases the quality of the results, motivates the laboratory personnel and is beneficial for all interested bodies. Continous improvement and dedicated people are the key elements for continuation of the quality assurance in an accredited medical laboratory.