A well- structured document man- agement system links policies, process de- scriptions, procedures, forms, and records to- gether in an organized and workable system. As with all previous editions, this revision is based on the solid foundation of knowledge gathered by past contributors to whom we are indebted. The donor history form and blood sample tubes are similarly la- beled with the unique number for each dona- tion. Forms should be carefully designed to be easy to use, minimize the likelihood of errors, facilitate data and in- formation retrieval, effectively capture out- comes, and support process traceability When it is not immediately evident what data should be recorded or how to record them, forms should include instructions for their use. Low-volume autologous collections may be retained if they are approved by a physi- cian.
When equipment is found to be operating outside acceptable parameters, the potential effects on the quality of products or test results must be evaluated and documented. Criterios de auditorías para la utilización de sangre Trasplantes 29. Additional assess- ments should include, where appropriate, 1 therapeutic apheresis; 2 use of blood recov- ery devices; 3 procurement and storage of he- matopoietic progenitor cells; 4 perioperative autologous blood collection; 5 procurement and storage of tissue; and 6 evaluation of evolving technologies and products, such as growth factors and cytokines. Most blood centers and hospitals surmount the associated collection, storage, and tracking logistical difficulties to provide this service. Wan- ing interest in autologous donations may re- flect the decline in viral risk associated with allogeneic blood transfusion and, consequent- ly, the minimal medical benefit and increased cost of autologous blood. Cold Agglutinin Titer Procedure Method 4-8.
Cancer Each year in the United States, blood centers receive hundreds of reports of cancer in indi- viduals who had donated blood. N Engl J Med 2006;355: 1730-5. No deferral for receipt of toxoids or synthetic or killed viral, bacterial, or rickettsial vaccines listed below if the donor is symptom free and afebrile. Howerton D, Anderson N, Bosse D, et al. Confirming Anti -A : in an A, or Weak A Subgroup Method 2-10. Examples of quality assurance activities in transfusion medicine and cellular therapies include record reviews, monitoring of quality indicators, and internal assessments. Along the same lines, I want to welcome Dr.
J Clin Apher 2010;25: 331-7. The facility should be kept clean and well maintained so that the products and services provided are not com- promised. Preoperative autologous blood do- nation: A therapy that needs to be scientifical- ly evaluated. It addresses the leadership role of executive management in creating a commitment to quality throughout the organization, the un- derstanding of suppliers and customers as partners in quality, the management of human and other resources, and quality planning. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the Publisher. However, even when effective end-product testing can be achieved, it is ad- visable to validate important processes to gen- erate information that can be used to optimize performance. To pool blood products Appropriate use of a sterile connecting device to pool platelets prepared from whole blood collection may obviate potential contamination from the spike and port entries commonly used.
Risk Assessment The cornerstone of an effective disaster man- agement program is a thorough assessment of the known hazards that can affect the organi- zation. These various deferral policies are currently defensible but should be reevaluated if new in- formation becomes available about the poten- tial for cancer transmission through blood transfusion. Effec- tive corrective and preventive action cannot be implemented until the underlying cause is determined and the process is evaluated in re- lationship to other processes. Hemolytic Disease of the Fetus and Newborn — Introduction Method 5-1. Withdrawals are much more common than recalls but are not published. The quality oversight personnel should assist in the development, review, and approv- al of training programs, including the criteria for retraining.
The original wording must not be obliterated in written records; the original may be crossed out with a single line, but it should remain legible. A continuing process of education for emergency managers at both the local and national levels is imperative to in- crease their awareness of issues related to blood. Potential Consequences on Operations Emergencies involving power outages, floods, or structural damage to facilities disrupt nor- mal operations. The service should review contracts and agreements to en- sure that all important aspects for their critical materials and services are addressed. During the assessment phase, it is impor- tant to know who is responsible for the asses- sors or inspectors while they are in the facility. For example, drills should address 1 the need to transport blood from a blood center to a hospital or hospitals to treat victims when local roads have been damaged or destroyed and 2 the effect of an unknown bio- logic agent release on the local blood supply, donors eg, need to defer donors , or both.
Internal and External Disaster Drills Drills can be conducted internally eg, a fire drill or simulated hazardous spill cleanup or in conjunction with other organizations. You could be submitting a large number of automated requests to our search engine. Staffing Blood centers and hospitals depend on their highly trained, competent, and motivated staff and volunteers to be successful in their mis- sion of recruiting blood donors and collecting, manufacturing, testing, and distributing blood components. Clin Lab Med 2007;27: 845-58. These indicators can be process based or outcome based. A well- structured document man- agement system links policies, process de- scriptions, procedures, forms, and records to- gether in an organized and workable system.
The pulse rate is often low during vasovagal reactions, but the rate is often high during volume depletion. Rec- ords provide evidence of what did happen ie, that a process was performed as intend- ed , and provide information needed to as- sess product and service quality. Aabb Technical Manual 16th Edition Pdf Free Download. Criterios de auditorías para la utilización de sangre Trasplantes 29. Geographic considerations must be taken into account in identifying off-site stor- age locations.
Above all else, the most important benefit of careful and continual planning is assurance that blood and blood components are avail- able to patients when and where needed. Such sorting or stratification can result in identification of situations that require closer monitoring or problems needing corrective or preventive action. Identificación de anticuerpos dirigidos contra antígenos eritrocitarios 17. Department of Homeland Securi- ty, 2008:4-8. Using the American Rare Donor Program 4. The facility should define in writing the authority and responsibilities of executive management to establish and maintain the quality management system. Calibrating Centrifuges for Platelet Separation Method 8-7.
These centers then allow these indi- viduals to donate if they have been asymptom- atic and able to perform their usual daily activities during this interval. The number of incorrect test result reports is an example of such an indicator. Many blood collectors no longer use social security numbers for donor identification because of regulations restricting their use and privacy concerns. Executive management needs to clearly com- municate its commitment to quality goals and create an organizational culture that embraces quality principles. Limited effectiveness of donor deferral registries for transfusion- transmitted disease markers. Assessments should cover the quality system and the major operating systems in the donor center and transfusion or cellular therapy service. No deferral for receipt of intranasal live attenuated flu vac- cine.