How clinicians should use the diagnostic laboratory in a changing medical world

In developed countries, clinicians are faced with a plethora of diagnostic tests to apply to patients to guide their clinical management. The quality, effectiveness, and efficiency of patient care should be foremost in the clinician's mind. Laboratory directors should make every effort to guide clinicians in appropriate laboratory test ordering, interpretation, and resulting actions. Medicine, being at its center a moral enterprise grounded in a covenant of trust, and laboratory medicine being a subset of medicine, must first care and advocate for the patient, and consider clinical outcomes as most important.     

Evidence-based laboratory medicine

Evidence-based medicine (EBM) is a method for solving problems concerning the assessment of laboratory testing in patient care. Practising EBM involves the use of the available evidence to make health care decisions. The best way to practice EBM is the development, validation and implementation of guidelines. Guidelines are considered as the process by which healthcare research and experience are translated into improved patient care. In laboratory diagnostics EBM can be best demonstrated in high-prevalence conditions. Because of the number of patients encountered, high-prevalence conditions have a greater impact on patient morbidity and health care expenditure. In evidence-based laboratory medicine the best evidence comes from systematic reviewing studies of diagnostic tests. The reviewing of diagnostic trials and the development of good practice guidelines on the basis of these studies must be an important task of the scientific associations of clinical chemistry and laboratory medicine.     

Charting the course of medical laboratories in a changing environment

BACKGROUND: In recent decades, dramatic changes have occurred in the organization, number and type of tests, and role of medical laboratories in healthcare. The role of laboratory professionals has undergone a radical change, which calls for greater analytical accuracy, and more stringent test selection, and interpretation of results. METHODS: The ancillary role of clinical laboratories in the past was analyzed in order to understand why the change has taken place, and to identify old and new areas in which laboratory information is largely used for improving upon decision making for treatment, and patient management. RESULTS: The availability of real-time laboratory results and more effective tests, the enhanced clinical consulting role, the involvement in therapeutic decisions, the efforts to prevent rather than cure disease, the shift from anecdotal care to evidence-based medicine, and the assessment of outcome for laboratory tests have all contributed to the changing role and duties of medical laboratories. CONCLUSIONS: Crucial elements in sustaining the changes in the role and contribution of medical laboratories to a high-quality healthcare are the ability of laboratory professionals to: guarantee the quality of laboratory tests irrespective of where they are performed; improve the quality of services; improve clinical outcomes; and perform joint clinical/laboratory research projects. A key factor in effecting the change has been the awareness of the importance of the knowledge and skills required for the new role of laboratory professionals.     

COVID‐19‐another influential event impacts on laboratory medicine management

BackgroundBefore public health emergencies became a major challenge worldwide, the scope of laboratory management was only related to developing, maintaining, improving, and sustaining the quality of accurate laboratory results for improved clinical outcomes. Indeed, quality management is an especially important aspect and has achieved great milestones during the development of clinical laboratories.Current statusHowever, since the coronavirus disease 2019 (COVID‐19) pandemic continues to be a threat worldwide, previous management mode inside the separate laboratory could not cater to the demand of the COVID‐19 public health emergency. Among emerging new issues, the prominent challenges during the period of COVID‐19 pandemic are rapid‐launched laboratory‐developed tests (LDTs) for urgent clinical application, rapid expansion of testing capabilities, laboratory medicine resources, and personnel shortages. These related issues are now impacting on clinical laboratory and need to be effectively addressed.ConclusionDifferent from traditional views of laboratory medicine management that focus on separate laboratories, present clinical laboratory management must be multidimensional mode which should consider consolidation of the efficient network of regional clinical laboratories and reasonable planning of laboratories resources from the view of overall strategy. Based on relevant research and our experience, in this review, we retrospect the history trajectory of laboratory medicine management, and also, we provide existing and other feasible recommended management strategies for laboratory medicine in future.     

The laboratory is a key partner in assuring patient safety

Medical errors have a great impact on patient outcomes. They can cause serious injury to patients or even result in their deaths. However, morbidity and mortality can sometimes be prevented by the timely and effective action of health care workers. Several IOM Reports have focused on the problem of errors in the United States health care system and identified gaps that need to be addressed. As part of the overall health care system, clinical laboratories are vulnerable to medical errors. Because of significant efforts on the part of both the laboratories and the manufacturers of laboratory equipment and reagents, the errors in the analytic phase of the total testing process now represent the smallest portion of testing errors. Currently, laboratory testing errors occur most frequently in the preanalytic phase. The primary reason for the high prevalence of preanalytic errors is that, at the present time, it is difficult to monitor all preanalytic variables and to implement necessary improvement processes, particularly when some of the variables (like phlebotomy) are not under the control of the laboratory. Considerable efforts have been made by laboratory professionals and other stakeholders to decrease testing errors. Minimal quality requirements have been set through regulations for both laboratory testing and the manufacture of medical equipment and reagents. At the same time, nonregulatory approaches have greatly affected the quality of laboratory testing. These include laboratory standards, various quality improvement programs, voluntary reporting of adverse events, and, in the near future, the National Report on the Quality of Laboratory Services. The introduction of successful approaches from other industries, such as Six Sigma and Lean, also will help reduce the rate of laboratory errors. The clinical laboratory has done more than most other sectors of health care to decrease the occurrence of medical errors, making it a key partner inpatient safety.     

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.     

Categorizing outcomes of health care delivery

After a patient presents with symptoms of illness and undergoes treatment, there are three features of care that require assessment: the impact of delivering care on the patient, the benefits and harms of treatment, and the functioning of the health care system. This formulation leads to three types of outcomes of care delivery that require assessment: 1) patient outcomes, which reflect the impact on patients of undergoing care; 2) treatment outcomes, which reflect the intended and unintended medical consequences of undergoing therapy; and 3) system outcomes, which reflect the impact on the system of delivering health care to a group of patients. In this paper, examples of these three types of outcomes are presented, with particular reference to coronary artery bypass graft surgery. It is argued that the current focus of computer simulation models on system outcomes should be expanded to include patient and treatment outcomes.     

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.     

A risk assessment based approach to the management of acute poisoning

Early assessment and management of poisoning constitutes a core emergency medicine competency. Medical and psychiatric emergencies coexist; the acute poisoning is a dynamic medical illness that represents an acute exacerbation of a chronic underlying psychosocial disorder. The emergency physician must use an approach that ensures early decisions address potentially time critical interventions, while allowing management to be tailored to the individual patient's needs in that particular medical setting. This article outlines a rationale approach to the management of the poisoned patient that emphasises the importance of early risk assessment. Ideally, this approach should be used in the setting of a health system designed to optimise the medical and psychosocial care of the poisoned patient.     

Why outcomes measurement must be the basis for the development of clinical guidelines

Three approaches to clinical quality improvement, health care standards, clinical guidelines, and quality improvement research, are differentiated by the quality of the available medical evidence linking health care processes to health care outcomes. The key determinant of Permanente Medical Group physician acceptance and use of a clinical guideline is the belief that solid data links the guideline's advice to improved patient outcomes. Purchasers, government agencies, regulatory organizations, and health plans must understand the difference between health care standards and clinical guidelines. Strict adherence to clinical guidelines should never be the basis for accountability for physicians, medical groups, or organized systems of care.     

A National Center for EMS Provider andPatient Safety: Helping EMS Providers Help Us

With the strong encouragement of leading health care agencies, business principles are being implemented throughout health care, including emergency medical services (EMS). The reason is simple—quality of care can be enhanced by incorporating the management concepts of continuous quality improvement (CQI). The CQI process couples carefully identified, measurable performance indicators with information systems to monitor, analyze, and trend data. Benchmarking outcomes with other EMS systems allows the identification of “best practices” and the evolution of standards. Emergency medical services professionals must actively participate with the broader health care community in creating performance measurements to ensure that high-quality care is delivered consistently.     

Predictors of doctor‐rated and patient‐rated gout severity: gout impact scales improve assessment

Rationale, aims and objectives Our objective was to describe the factors associated with doctor‐rated and patient‐rated gout severity to explain how doctor assessment involving patient‐reported outcomes can improve the clinical management of gout. Methods Patients completed a newly validated gout‐specific health‐related quality of life instrument, the Gout Impact Scale (GIS) and other questions regarding their gout. Both patients and their doctors gave an overall gout severity assessment. We conducted correlation analyses between each predictor of interest and the two different severity ratings (doctor‐rated severity and patient‐rated severity). Stepwise multiple regressions were performed to determine the best predictors for doctor‐rated and patient‐rated severity, respectively. Results Doctor‐rated severity more closely correlated with objective clinical and laboratory findings, particularly the presence of tophi, which was not a leading factor in patient‐rated severity assessments. Patient‐rated severity more closely correlated with the domains of the GIS, which expressed the impact of gout on health‐related quality of life. Conclusion Doctors might have a better understanding of their patients' level of disease impact if they incorporate an instrument such as the GIS in their evaluation of gout severity and their decisions regarding aggressiveness of treatment. The increased use of patient‐reported outcomes measures has the potential to improve quality of care and patient satisfaction, as well as reduce costs of health care utilization.     

Continuous quality improvement in the ambulatory endoscopy center

What does quality assessment have to do with the practicing gastroenterologist? Why should one spend the time and effort to incorporate CQI activities into an already busy practice? First and foremost, quality improvement should directly benefit the patient by ensuring that they receive the highest quality of care possible. For example, comparing endoscopic use or outcomes, such as procedure success or complications, with national standards or other endoscopists in the same community may identify physicians who could benefit from additional training. Similar analyses may likewise identify outstanding physicians who might serve as resources for other physicians. Surveys of patient satisfaction may reveal deficiencies, which might be unknown to a physician who is otherwise technically excellent; deficiencies that would never have been uncovered by traditional measures of quality. Second, applying the techniques of CQI to study one's own practice can provide a competitive edge when vying for managed care or corporate contracts. In this regard, CQI can be used to document physician or practice performance through tracking of endoscopic use, procedure success and complication rates, and patient satisfaction. Finally, the rising concern among various patient advocacy groups has led to an increased emphasis on quality improvement, and in most cases it is a required activity as part of the accreditation process. Steps to quality improvement There is more to quality improvement than simply selecting and implementing a performance improvement plan. A number of steps have been suggested to achieve fundamental improvement in the quality of medical care [3]. The first is to use outcomes management for improvement rather than for judgment. One of the major criticisms of QA is that it will be used to judge physicians providing care. It is feared that CQI will be used to identify poor performers who will then be punished. This strategy leads to fear and inhibits an honest pursuit of improvement. Second, learning must be viewed as a process. A quality improvement plan that is successful in one setting may not be as favorable in another situation. Clinicians must be able to focus on their individual situations and adapt what others have implemented to their own practice. Third, the most important aspect of the quality improvement is the implementation step. It matters little if elegant studies of endoscopic complications or patient satisfaction are completed if the information is not used to improve the delivery of health care to every single patient. The delivery of medical care continues to evolve. Resources are becoming increasingly scarce and the progressive rise of health care expenditures suggests a need for control. In this zeal for cost constraint, quality must not be sacrificed. This new-found attention to quality must be extended to the level of the individual practitioner to ensure that individual patients' interests are protected and the best possible care is delivered regardless of the economic implications. As providers of health care, endoscopists need to take an active role in these efforts both in understanding and implementing the techniques of quality assessment into their practices. If physicians are not actively involved in data collection and measurement to improve the quality and value of their own work, someone else will undoubtedly assume this role.     

How can we make laboratory testing safer?

BACKGROUND: Diagnostic errors occur in laboratory medicine resulting from an error or delay in diagnosis, a failure to employ indicated tests, and the use of outmoded tests. Since laboratory tests provide essential information used by physicians to make medical decisions, it is important to determine how often laboratory testing mistakes occur, whether they cause patient harm, where they are most likely to occur in the testing process, and how to prevent them from occurring. METHODS: The US Quality Institute Conference in 2003 and the Institute for Quality in Laboratory Medicine in 2005 brought together providers of, users of, and payers for laboratory services to explore how working together they could help to reduce laboratory testing errors and enhance patient safety. RESULTS AND CONCLUSIONS: Users of and payers for laboratory services must become partners in the laboratory's efforts to reduce laboratory testing errors and enhance patient safety. They must be linked to a laboratory information system that provides assistance in decisions on test ordering, patient preparation, and test interpretation. Laboratory quality assessment efforts need to be expanded to encompass the detection of non-analytical mistakes. Healthcare institutions need to adopt a culture of safety that is implemented at all levels of the organization.     

University of Iowa Hospital and Clinics: outcomes management

Delivery of quality patient care and management of patient outcomes is critical to the success of academic medical centers in the ever-changing health care market. The University of Iowa Hospitals and Clinics (UIHC) promotes quality care through the provision of organizational structures and processes that are described in this article. In addition, quality of care and outcomes management are described by members in various roles within the UIHC health care system. It is the authors' belief that understanding quality from these various perspectives helps UIHC work across departments to achieve excellence in patient care.     

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.     

Patient safety, errors and mistakes, and perioperative nursing

Today's world of advancing technology in health care represents complex diagnostic, operational, and administrative processes, all of which must be coordinated to ensure the delivery of safe, quality health care. Nonetheless, the health care industry's implementation and practice of quality measures fall below the standards of other industries, such as aerospace, telecommunications, or information technology. With health care performing at this lower level, it is no wonder that headline grabbers dwell on the deaths that occur as a result of medical errors. A new emphasis on quality management is essential in nursing education and in quality management to improve US health care. This article summarizes recent reports on medical errors and suggests strategies to improve patient safety.     

Congestive heart failure education study.

Nursing staff providing care to patients on a medical/surgical unit must be generalists rather than specialists in disease management. The diversity of illnesses seen among this population requires the nurse to be expert in many disease processes. The complexity of patients who are admitted to a medical/surgical unit continues to increase and is therefore challenging to nurses. Complex patient populations can be attributed to individuals living longer and the advancement of technology and information in treating serious medical conditions. Nursing expertise for different disease processes can vary according to experience, educational level, and knowledge regarding evidence-based practice. Lack of knowledge regarding current practice guidelines and care may result in poor patient outcomes and high cost. Confidence in performing safe and quality nursing care can also be affected by lack of knowledge. Continuing education for nursing must be made a priority for nurses to provide safe and high quality care. Education provided must be current and based on positive outcomes through research-based nursing practice.     

Considerations in the management of the patient with comorbid depression and anxiety

PURPOSE: To provide clinicians with guidelines for the assessment, evaluation, diagnosis, and management of comorbid depression and anxiety in the primary care setting. DATA SOURCES: Research-based articles in the medical and psychiatric literature, literature reviews by experts in the field, and DSM-IV-TR. CONCLUSIONS: Comorbid anxiety and depression occurs at a high rate in primary care, and is costly to both the individual and to society. These patients most often present in primary care settings, have more severe symptoms, and require more health care resources. The presentation of depression and anxiety together pose complicated diagnostic and treatment challenges, leading to inadequate diagnosis and treatment resulting in unnecessary patient distress and increased utilization of health care services. IMPLICATIONS FOR PRACTICE: This article is a review of comorbid depression and anxiety with a focus upon societal and patient significance and impact, under recognition and under treatment, diagnostic challenges, medical comorbidity, treatment considerations, and educational strategies. Effective assessment, evaluation, diagnosis and treatment can lead to better treatment outcomes and improved quality of life in primary care patients.     

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.