Stored red cells undergo progressive structural and functional changes over time. In a study of 6002 patients undergoing cardiac surgery at a single institution, those who received blood stored for ...14 days or less had lower rates of complications and death than those who received blood stored for more than 14 days.
In a study of patients undergoing cardiac surgery, those who received blood stored for 14 days or less had lower rates of complications and death than those who received blood stored for more than 14 days.
More than 14 million units of blood are transfused annually in the United States.
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Considerable evidence suggests that transfusion increases the risk of serious complications and death in critically ill patients,
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especially in patients who are undergoing cardiac surgery.
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Some studies have suggested that the risk of complications after transfusion also increases when transfused blood has been stored for long periods.
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Blood collection and storage systems licensed by the Food and Drug Administration allow red cells to be stored for up to 42 days. (The median duration of storage of transfused red-cell units in the United States . . .
The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories ...offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology.
To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or "dry bench" analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests.
To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results . -A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP's molecular pathology checklist (MOL).
This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
The Laboratory Accreditation Program of the College of American Pathologists (CAP) began in 2015 to allow accredited laboratories to devise their own strategies for quality control of laboratory ...testing. Participants now have the option to implement individualized quality control plans (IQCPs). Only nonwaived testing that features an internal control (built-in, electronic, or procedural) is eligible for IQCP accreditation. The accreditation checklists that detail the requirements have been peer-reviewed by content experts on CAP's scientific resource committees and by a panel of accreditation participants. Training and communication have been key to the successful introduction of the new IQCP requirements.
Topoisomerase (topo) IIα and IIβ maintain genome stability and are targets for anti-tumor drugs. In this study, we demonstrate that the decatenation checkpoint is regulated, not only by topo IIα, as ...previously reported, but also by topo IIβ. The decatenation checkpoint is most efficient when both isoforms are present. Regulation of this checkpoint and sensitivity to topo II-targeted drugs is influenced by the C-terminal domain (CTD) of the topo II isoforms and by a conserved non-catalytic tyrosine, Y640 in topo IIα and Y656 in topo IIβ. Deletion of most of the CTD of topo IIα, while preserving the nuclear localization signal (NLS), enhances the decatenation checkpoint and sensitivity to topo II-targeted drugs. In contrast, deletion of most of the CTD of topo IIβ, while preserving the NLS, and mutation of Y640 in topo IIα and Y656 in topo IIβ inhibits these activities. Structural studies suggest that the differential impact of the CTD on topo IIα and topo IIβ function may be due to differences in CTD charge distribution and differential alignment of the CTD with reference to transport DNA. Together these results suggest that topo IIα and topo IIβ cooperate to maintain genome stability, which may be distinctly modulated by their CTDs.
Allergic reaction to transfusion is common. However, the review of a large series of allergic transfusion reactions has not been performed.
To review a large series of allergic transfusion reactions.
...A retrospective review of all reported and evaluated transfusion reactions during a 9-year period at 1 institution was performed. Associated clinical signs and symptoms were evaluated.
Large, tertiary-care teaching hospital.
A total of 1613 adverse reactions to transfusion were evaluated. Allergic transfusion reactions accounted for 17% (273 of 1613) of the transfusion reactions. Severe allergic reactions (anaphylaxis, anaphylactoid signs and symptoms, and/or hypotension) were observed in 21 patients (7.7% of allergic reactions, or 1.3% of all transfusion reactions). Serum tryptase, a marker for anaphylaxis, was measured in 1 patient and determined to be borderline elevated. Five patients experienced allergic transfusion reactions to autologous red cell transfusions. One patient experienced hives during the transfusion of a major ABO mismatched red blood cell. A wide variety of skin manifestations were observed, but 26 (9.5%) patients did not have skin manifestations. Allergic transfusion reactions were estimated to occur in approximately 1 in 4124 blood components transfused, or 1 in 2338 transfusion episodes. Severe allergic reactions occurred in approximately 1 in 30,281 transfusions. No deaths directly attributable to transfusion were observed in this patient group.
The clinical presentation of allergic transfusion reactions was quite variable, and the pathophysiology remains unclear. Recommendations for clinical evaluation and therapy remain problematic and often empirical.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
OBJECTIVE To test the hypothesis that perioperative transfusion of allogeneic and autologous red blood cells (RBCs) stored for a prolonged period speeds biochemical recurrence of prostate cancer ...after prostatectomy. PATIENTS AND METHODS We evaluated biochemical prostate cancer recurrence in men who had undergone radical prostatectomy and perioperative blood transfusions from July 6, 1998, through December 27, 2007. Those who received allogeneic blood transfusions were assigned to nonoverlapping “younger,” “middle,” and “older” RBC storage duration groups. Those who received autologous RBC transfusions were analyzed using the maximum storage duration as the primary exposure. We evaluated the association between RBC storage duration and biochemical recurrence using multivariable Cox proportional hazards regression. RESULTS A total of 405 patients received allogeneic transfusions. At 5 years, the biochemical recurrence–free survival rate was 74%, 71%, and 76% for patients who received younger, middle, and older RBCs, respectively; our Cox model indicated no significant differences in biochemical recurrence rates between the groups ( P =.82; Wald test). Among patients who received autologous transfusions (n=350), maximum RBC age was not significantly associated with biochemical cancer recurrence ( P =.95). At 5 years, the biochemical recurrence–free survival rate was 85% and 81% for patients who received younger and older than 21-day-old RBCs, respectively. CONCLUSION In patients undergoing radical prostatectomy who require RBC transfusion, recurrence risk does not appear to be independently associated with blood storage duration.
Optimal patient care is best defined in terms of outcome. Reliable laboratory test results are important to patient safety. The laboratory must use the tools available to it to minimize the ...uncertainty of measurement. Three sources of error contribute to uncertainty: Intermethod bias, which is minimized and trueness of measure maximized when laboratories use calibrators and methods traceable to higher order, reference standards; imprecision inherent in the analysis, which is seen as small differences between replicate tests; interference from factors external to the test itself, which are seen as erroneous values markedly deviant from trueness. Although improbable, such contributions to total analytical error may be the most misleading. Risk is best managed by identifying the sources of error and controlling for those sources most likely to contribute to total analytical error. Comprehensive control of error requires the laboratory scientist and physicians caring for patients to work together to ensure interpretability of results. Practice guidelines are available from the Clinical and Laboratory Standards Institute to address each of these factors.
The Laboratory Accreditation Program of the College of American Pathologists monitors the performance of its subscribers in proficiency testing (PT). Failure to perform as expected prompts the ...program to query the laboratory.
To determine whether laboratories are correcting apparent problems when contacted by the program about repeatedly unacceptable performance in a diagnostic test.
Retrospective analysis of 1 year's records (2002-2003) from the College's Proficiency Testing Exception Summary correspondence, which identifies clusters of PT failures. The analysis focused on those laboratories in which the Proficiency Testing Exception Summary algorithm identified repeated failures over 3 or 4 testing events; PT performance is monitored as a condition of accreditation. During 1 survey year, approximately 6300 accredited laboratories collectively tested approximately 1,205,000 analytes and submitted results to their PT providers on more than 3,500,000 PT challenges. During the period of observation, 14,085 Proficiency Testing Exception Summary reports were mailed to participants. Educational materials were included to help laboratories identify and correct each PT failure.
There were only 1304 cases of repeated PT failures after the initial correspondence from the accreditation program (9.3%). Of these, there were only 119 cases of unsatisfactory results on the subsequent PT event (9.1%). All systematic problems were resolved by the conclusion of the third round of correspondence.
Accredited laboratories generally perform well in proficiency testing. Identification of clusters of PT failures by the accreditation provider can help those laboratories having analytic difficulties to investigate and correct the problems.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
First identified in the United States in 1999, West Nile virus caused approximately 3,500 infections in the late summer and fall of 2002. The virus is predominantly transmitted by mosquitoes, and the ...risk of infection through blood product transfusion is believed to be low. We present a case of West Nile virus encephalitis transmitted by red blood cell transfusion at the time of coronary artery bypass grafting that resulted in the patient’s death. Individuals undergoing procedures with high blood product transfusion requirements, such as cardiac surgery or organ transplantation, may be at higher risk of this nosocomial infection during epidemics.
The cost of patient safety Hoeltge, Gerald A
Clinical leadership & management review,
2004 Nov-Dec, Letnik:
18, Številka:
6
Journal Article
Recenzirano
To ensure patient safety, it costs an organization time, money, and commitment. The clinical laboratory may promote patient safety or may contribute to medical error. Laboratory errors put a patient ...at risk at any point along the path of workflow. The cost of an initiative in patient safety may be considered from four perspectives: compliance, feasibility, present risk, and financial. Three examples are offered to illustrate the use of these approaches. Most patient-safety strategies in laboratory medicine are not expensive. They are affordable with a structured outlay of existing resources and a willingness to follow defined work practices without exception. More extensive projects, especially those that cross jurisdictional lines within an organization, do require comprehensive project management. Management ofboth kinds of initiatives is addressed by NCCLS' documents on quality practice.
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