Patient Safety and Quality in Laboratory and Hemostasis Testing: A Renewed Loop?

More than three decades ago, George Lundberg first introduced the concept of the brain-to-brain loop for laboratory diagnostics. According to this pioneering model, the first step in the loop involves the selection of laboratory tests in the brain of the physician caring for the patient, and the final step is the transmission of test results back to the ordering physician. There are several intermediary steps, some of which are preanalytical (e.g., identification of patient and blood samples, the process of blood collection, and specimen handling); some are analytical and relate to the actual performance of the test(s); whereas others are postanalytical and involve release of test results into the medical record and further steps such as the physician's reaction to laboratory information, their interpretation of these results, and subsequent appropriate clinical action. Hemostasis testing should also be viewed within such a paradigm, so that quality throughout the total testing process can be assured. For hemostasis testing, particular attention is required to ensure provision of appropriate test samples in the preanalytical phase. Nevertheless, the timeliness of testing and an appropriate interpretation of test results are also paramount. This article overviews the concept of quality testing within hemostasis as critical to ensuring patient safety and optimal clinical and therapeutic management.

[1]  M. Bui,et al.  Book Review: So You’re Going to Collect a Blood Specimen , 2014 .

[2]  E. Favaloro,et al.  Proficiency testing/external quality assurance for the PFA-100® , 2012, Clinical chemistry and laboratory medicine.

[3]  G. Lippi,et al.  Quality Standards for Sample Processing, Transportation, and Storage in Hemostasis Testing , 2012, Seminars in Thrombosis & Hemostasis.

[4]  G. Lippi,et al.  Quality Standards for Sample Collection in Coagulation Testing , 2012, Seminars in Thrombosis & Hemostasis.

[5]  E. Favaloro,et al.  Clinical audit of antiphospholipid antibody testing in tertiary practice: towards improved relevance in thrombophilia investigations , 2012, Internal medicine journal.

[6]  B. Bikdeli,et al.  Prophylaxis for Venous Thromboembolism: A Great Global Divide between Expert Guidelines and Clinical Practice? , 2012, Seminars in Thrombosis & Hemostasis.

[7]  G. Westert,et al.  Needs and barriers to improve the collaboration in oral anticoagulant therapy: a qualitative study , 2011, BMC cardiovascular disorders.

[8]  G. Lippi,et al.  Laboratory testing of anticoagulants: the present and the future , 2011, Pathology.

[9]  G Lippi,et al.  Direct‐to‐consumer testing: more risks than opportunities , 2011, International journal of clinical practice.

[10]  Mario Plebani,et al.  The brain-to-brain loop concept for laboratory testing 40 years after its introduction. , 2011, American journal of clinical pathology.

[11]  S. Middeldorp,et al.  Thrombophilia in Childhood: To Test or Not to Test , 2011, Seminars in thrombosis and hemostasis.

[12]  G. Lippi,et al.  Laboratory diagnostics and appropriate care of people with haemophilia , 2011, Haemophilia : the official journal of the World Federation of Hemophilia.

[13]  Mario Plebani,et al.  Regulation of in vitro diagnostics (IVDs) for use in clinical diagnostic laboratories: towards the light or dark in clinical laboratory testing? , 2011, Clinical chemistry and laboratory medicine.

[14]  G. Lippi,et al.  Arterial thrombus formation in cardiovascular disease , 2011, Nature Reviews Cardiology.

[15]  Mario Plebani,et al.  Closing the brain-to-brain loop in laboratory testing , 2011, Clinical chemistry and laboratory medicine.

[16]  E. Favaloro,et al.  Assessment for antithrombin deficiency in the real world , 2011, International journal of laboratory hematology.

[17]  G. Lippi,et al.  Laboratory testing and/or monitoring of the new oral anticoagulants/antithrombotics: for and against? , 2011, Clinical chemistry and laboratory medicine.

[18]  E. Favaloro,et al.  A clinical audit of congenital thrombophilia investigation in tertiary practice , 2011, Pathology.

[19]  C. Otto Patient Safety and the Medical Laboratory Using the IOM Aims , 2011, American Society for Clinical Laboratory Science.

[20]  G. Lippi,et al.  Prevention of Venous Thromboembolism: Focus on Mechanical Prophylaxis , 2011, Seminars in thrombosis and hemostasis.

[21]  G. Di Minno,et al.  Prevention of Venous Thromboembolism in Medical Patients with Thrombocytopenia or with Platelet Dysfunction: A Review of the Literature , 2011, Seminars in thrombosis and hemostasis.

[22]  J. Barth Clinical quality indicators in laboratory medicine: a survey of current practice in the UK , 2011, Annals of clinical biochemistry.

[23]  M. Pai,et al.  Critical values in the coagulation laboratory: results of a survey of the North American Specialized Coagulation Laboratory Association. , 2011, American journal of clinical pathology.

[24]  E. Favaloro More on preanalytical variables affecting platelet function testing using light transmittance aggregometry , 2011, Clinical chemistry and laboratory medicine.

[25]  G. Lippi,et al.  Coagulation update: what's new in hemostasis testing? , 2011, Thrombosis research.

[26]  A. Cohen What is value in health care? , 2011, The New England journal of medicine.

[27]  S. Sandberg,et al.  External quality assessment of point-of-care International Normalized Ratio (INR) testing in Europe , 2011, Clinical chemistry and laboratory medicine.

[28]  M. Popovsky,et al.  Clinical Utility of Thromboelastography: One Size Does Not Fit All , 2010, Seminars in thrombosis and hemostasis.

[29]  G. Lippi,et al.  Notification of abnormal and critical values: the road ahead. , 2010, The American journal of medicine.

[30]  D. Fitzmaurice,et al.  Point‐of‐care testing in haemostasis , 2010, British journal of haematology.

[31]  N. Elder,et al.  Crossing the finish line: follow-up of abnormal test results in a multisite community health center. , 2010, Journal of the National Medical Association.

[32]  Mario Plebani,et al.  Is laboratory medicine a dying profession? Blessed are those who have not seen and yet have believed. , 2010, Clinical biochemistry.

[33]  G. Lippi,et al.  Quality issues in laboratory haemostasis , 2010, Haemophilia : the official journal of the World Federation of Hemophilia.

[34]  Mario Plebani,et al.  The “hospital central laboratory”: automation, integration and clinical usefulness , 2010, Clinical chemistry and laboratory medicine.

[35]  G. Lippi,et al.  Laboratory testing in pharmacies , 2010, Clinical chemistry and laboratory medicine.

[36]  E. Favaloro,et al.  Quality in coagulation and haemostasis testing , 2010 .

[37]  G. Lippi,et al.  Contemporary platelet function testing , 2010, Clinical chemistry and laboratory medicine.

[38]  M. Laposata,et al.  Assessment of critical values policies in Italian institutions: comparison with the US situation , 2010, Clinical chemistry and laboratory medicine.

[39]  Mario Plebani,et al.  The detection and prevention of errors in laboratory medicine , 2010, Annals of clinical biochemistry.

[40]  G. Lippi,et al.  Laboratory reporting of hemostasis assays: the final post-analytical opportunity to reduce errors of clinical diagnosis in hemostasis? , 2010, Clinical chemistry and laboratory medicine.

[41]  Izvorni znanstveni članak Quality in laboratory diagnostics : from theory to practice , 2010 .

[42]  G. Lippi,et al.  The role of ethnicity, age and gender in venous thromboembolism , 2010, Journal of Thrombosis and Thrombolysis.

[43]  B. Goswami,et al.  Pre-analytical factors that influence the interpretation of prothrombin time in the clinical laboratory: one year experience in a super speciality hospital in India. , 2009, Clinica chimica acta; international journal of clinical chemistry.

[44]  A. Viswanathan,et al.  Unsuspected coagulopathy rarely prevents IV thrombolysis in acute ischemic stroke , 2009, Neurology.

[45]  Giuseppe Lippi,et al.  Laboratory investigation of thrombophilia: the good, the bad, and the ugly. , 2009, Seminars in thrombosis and hemostasis.

[46]  G. Lippi,et al.  Influence of temperature and time before centrifugation of specimens for routine coagulation testing , 2009, International journal of laboratory hematology.

[47]  Mario Plebani,et al.  Exploring the iceberg of errors in laboratory medicine. , 2009, Clinica chimica acta; international journal of clinical chemistry.

[48]  E. Favaloro Internal quality control and external quality assurance of platelet function tests. , 2009, Seminars in thrombosis and hemostasis.

[49]  M. Laposata,et al.  Evaluation of effectiveness of a computerized notification system for reporting critical values. , 2009, American journal of clinical pathology.

[50]  G. Lippi,et al.  Milestones and perspectives in coagulation and hemostasis. , 2009, Seminars in thrombosis and hemostasis.

[51]  Giuseppe Lippi,et al.  Development and implementation of an automatic system for verification, validation and delivery of laboratory test results , 2009, Clinical chemistry and laboratory medicine.

[52]  G. Lippi,et al.  Pathogenesis of venous thromboembolism: when the cup runneth over. , 2008, Seminars in thrombosis and hemostasis.

[53]  G. Lippi,et al.  Preanalytical and Postanalytical Variables: The Leading Causes of Diagnostic Error in Hemostasis? , 2008, Seminars in thrombosis and hemostasis.

[54]  M. Plebani,et al.  Quality control in coagulation testing. , 2008, Seminars in thrombosis and hemostasis.

[55]  G. Lippi,et al.  Prevalence and type of pre-analytical problems for inpatients samples in coagulation laboratory. , 2008, Journal of evaluation in clinical practice.

[56]  B. Lämmle,et al.  Stability of coagulation assays performed in plasma from citrated whole blood transported at ambient temperature , 2008, Thrombosis and Haemostasis.

[57]  G. Lippi,et al.  Influence of the centrifuge time of primary plasma tubes on routine coagulation testing , 2007, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[58]  Anand Dighe,et al.  “Pre-pre” and “post-post” analytical error: high-incidence patient safety hazards involving the clinical laboratory , 2007, Clinical chemistry and laboratory medicine.

[59]  E. Favaloro Preanalytical variables in coagulation testing. , 2007, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[60]  C. Kluft,et al.  Performance goals for the laboratory testing of antithrombin, protein C and protein S , 2006, Thrombosis and Haemostasis.

[61]  G. Lippi,et al.  Quality and reliability of routine coagulation testing: can we trust that sample? , 2006, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[62]  G. Lippi,et al.  Preanalytical variability: the dark side of the moon in laboratory testing / Präanalytische Variabilität: die Schattenseite klinischer Laboruntersuchungen , 2006 .

[63]  Giuseppe Lippi,et al.  Laboratory medicine in the 2000s: programmed death or rebirth? , 2006 .

[64]  G. Lippi,et al.  Short-term venous stasis influences routine coagulation testing , 2005, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[65]  F. Meier,et al.  Heparin monitoring and patient safety: a College of American Pathologists Q-Probes study of 3431 patients at 140 institutions. , 2009, Archives of pathology & laboratory medicine.

[66]  Anand S Dighe,et al.  Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering. , 2004, Archives of pathology & laboratory medicine.

[67]  A. Dighe,et al.  Narrative interpretations for clinical laboratory evaluations: an overview. , 2001, American journal of clinical pathology.

[68]  D. Bruns,et al.  Laboratory-related outcomes in healthcare. , 2001, Clinical chemistry.

[69]  C G Fraser,et al.  Introduction: strategies to set global quality specifications in laboratory medicine. , 1999, Scandinavian journal of clinical and laboratory investigation.

[70]  G. Agnelli,et al.  Management of Oral Anticoagulant Therapy in Italy , 1999, Seminars in thrombosis and hemostasis.

[71]  G D Lundberg,et al.  The need for an outcomes research agenda for clinical laboratory testing. , 1998, JAMA.

[72]  R. Marlar,et al.  Minimum specimen volume requirements for routine coagulation testing: dependence on citrate concentration. , 1998, American journal of clinical pathology.

[73]  G D Lundberg,et al.  Acting on significant laboratory results. , 1981, JAMA.

[74]  F. Peabody The Physician and the Laboratory , 1922 .