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AABB TECHNICAL MANUAL of graft-vs-host disease (GVHD), which is also mediated by T-cells, was protective and re- duced the chance of relapse Changes to the Technical Manual, 18th Edition. Monday, November 17, 12 p.m. – p.m. (ET) / p.m. – p.m. (GMT). When this file is opened. technical manual 18th edition free download pdf may not make exciting reading, but aabb technical manual 18th edition free download is packed with valuable.

Hillyer and ing. An increasing number of organizations Grossman who have helped guide previous seek the more detailed test results possible editions. With the 18th edition they both con- through investments in molecular technology. Along Those in the workforce today need or soon the same lines, I want to welcome Dr.

Westhoff will need a solid understanding of the both who has joined me in this new challenge of the theory and practice of molecular testing providing an up-to-date comprehensive systems, which is found in this volume. First, medium found inside the back cover. By mov- the cellular therapy content has been ing the methods into the digital format, we are expanded and reorganized to include many able for the first time to give Technical Manual novel therapies that are moving from the users methods that are already set up as stan- research setting into the clinical realm.

In dard operating procedures SOPs —in a tem- addition to updates on the sources of stem plate that reflects how procedures would cells and the transfusion support of stem cell actually be used in real-life.

Users are invited transplantation, chapters focus on the quality to upload the methods to their facility net- and regulatory issues associated with cord works and customize them for integration into banking, novel stem cell therapies using non- their existing SOPs.

The new scope will be of great value to the tions, all chapters have been revised. Some of increasing number of professionals who now the chapter authors have added substantial include some aspect of cellular therapy in updates in great detail to assist the reader, their daily responsibilities. In a similar manner, the content on They have embraced the task of explaining the patient blood management PBM reflects the issues that face all of us in the ever-changing growing scope of what is considered PBM.

The world of transfusion medicine and cellular traditional topics covered as part of discus- therapies. We welcome your comments and sions on blood utilization review and periop- feedback on the effectiveness of our labors.

Quality Management Systems: Theory and Practice. Glossary of Commonly Used Quality Terms. Facilities, Work Environment, and Safety. Appendix Biosafety Level 2 Precautions. Incidental Spill Response. Managing Hazardous Chemical Spills. Regulatory Issues in Blood Banking. Disaster Management. Allogeneic and Autologous Blood Donor Selection. Whole-Blood Collection and Component Processing. Blood Component Collection by Apheresis. Infectious Disease Screening. Key Points. Molecular Biology and Immunology in Transfusion Medicine.

Blood Group Genetics. The Rh System. Rh Genes and Rh Proteins. Other Blood Group Systems and Antigens. Pretransfusion Testing. Downes, MD, and Ira A. Shulman, MD Requests for Transfusion.

Identification of Antibodies to Red Cell Antigens. Selecting Blood for Transfusion. Drugs Associated with Immune Hemolytic Anemia.

Platelet and Granulocyte Antigens and Antibodies. The HLA System. Bray, PhD; Marilyn S. Pollack, PhD; and Howard M. Hemotherapy Decisions and Their Outcomes. Administration of Blood Components. Responsibilities for Activity Levels 1. Neonatal and Pediatric Transfusion Practice. Patient Blood Management. Meghan Delaney. Perinatal Issues in Transfusion Practice. Older Infants. Mark A. MD Hemovigilance. Vincent Indianapolis Hospital Since Approaches to Blood Utilization Auditing.

Noninfectious Complications of Blood Transfusion. MD Principles and Modalities. Transfusion Order Form in Use at St.

Therapeutic Apheresis. Umbilical Cord Blood Banking. MD Clinical Utility. Brian Johnstone. McKenna Jr. Eapen K.

Sreedhar Thirumala. Dilution of Percentage Solutions Procedure Method Serum Dilution Procedure Method Focus on Cell Culture and Handling. Shipping Hazardous Materials Method Solution Preparation Procedure Method Human Allografts and the Hospital Transfusion Service.

Treating Incompletely Clotted Specimens Method MD Tissue Transplantation. Edward R. General Laboratory Methods—Introduction Method Standardizing Enzyme Procedures. Antibody Detection. Prewarming Procedure Method Preparing and Using Phosphate Buffer Method Testing Saliva for A.

Preparing Papain Enzyme Stock. Reading and Grading Tube Agglutination 2. Testing for Weak D Method Preparing and Using Lectins Method Preparing Ficin Enzyme Stock. Cold Autoadsorption Procedure Method Antibody Titration Procedure Method Component Preparation.

Heat Elution Procedure Method Two-Stage Enzyme Procedure Method Performing the Donath-Landsteiner Test Method Polyethylene Glycol Adsorption Procedure Method Adsorption Procedure Method Blood Collection.

Cold-Acid Elution Procedure Method Using the American Rare Donor Program 4. Cold Agglutinin Titer Procedure Method One-Stage Enzyme Procedure Method Neutralizing Anti-Sda with Urine Method Performing a Direct Antiglobulin Test Method Testing Freezer Alarms Method Transplantation of Cells and Tissue—Introduction Method Testing Refrigerator Alarms Method Quality Control Methods—Introduction Method Preparing Platelets from Whole Blood Method Directory of Organizations.

Selected Normal Values in Children Appendix 3. Calibrating Electronic Oral Thermometers Method Validating Copper Sulfate Solution Method Approximate Normal Values for Red Cell. Normal Values in Adults Appendix 2. Processing Umbilical Cord Blood Method Infusing Cryopreserved Hematopoietic Cells Method Examples of Correct and Incorrect Terminology Appendix 9. Removing Plasma from Platelets Volume Reduction 7. Calibrating Centrifuges for Platelet Separation Method Testing Automatic Cell Washers Method Examples of Gene.

North Carolina. University of Cincinnati. New York. Interim Department Head. College of Allied Health Sciences. A quality management system in. Quality Director. Betsy W. This commitment to tions CFR Title Analytical and Diagnostic Sciences. Professional and accrediting organizations ment to achieve and maintain quality. New York Blood Center. Part Esoteric Business Unit.

A glos. Vice Presi- dent for Quality and Regulatory Affairs. C h a p t e r 1 Quality Management Systems: Theory and Practice Tania L. AABB standards use a quali. Clinical and Laboratory Standards Institute The establishment of a formal quality as. Laboratory Corporation of America.

Ohio The authors have disclosed no conflicts of interest. Develop product and service specifications personnel. The AABB has defined the minimum ele. Identify the customers.

AABB Technical Manual 18th Ed 2014

It addresses the leadership role of executive ments that must be addressed in its quality management in creating a commitment to system essentials QSEs. During the planning erators and volume or cell counts on finished phase. FDA quality system approaches. Quality assurance provides infor. This model until a problem has been resolved something centers around three fundamental processes is found to be out of control.

Examples of tem. Develop operational processes for produc- operational performance data to determine tion and delivery. Quality assurance activities are not tied to the actual performance of a process. Program15 provides an excellent framework for Quality management considers interrelat- implementing quality on an organizational ed processes in the context of the organization level. Determine customer needs and expecta- procedures SOPs. Quality assurance activities also and accreditation requirements.

Quality Assurance. Establish quality goals for the project. Develop process controls and validate the attention. Evaluation of performance. Supplier qualification. Comparison of performance to goals. Action to correct any discrepancy between the two.

End-product testing other variables that affect the process. These output measurements and quality. These who are not eligible do not enter the selection tools help determine if a process is stable process. An understanding of ations that includes the following: One way that donor centers at- cility to evaluate process performance during tempt to minimize this cost is to educate po- tential donors before screening so that those the planning stage and in operations. Controls that do not add value donor who can continue to the next process should be eliminated to conserve limited blood collection or an ineligible donor who is resources and allow staff to focus attention on deferred.

When the selection process results in those controls that are critical to the opera.

For example. In the donor processes to use independent judgment ap- selection scenario. For When one designs quality management example.

Although the emphasis in a production ments. In service. Personnel involved in collecting and tion. Delivery gen- pies fields present new challenges.

Components staff to deliver safe and effective services that must be quarantined and their discard docu. Periodic as- erally involves interaction with the customer.

These basic elements include the fol- process is on minimizing variation to create a lowing: Part of quality planning is to Quality Management as an Evolving identify these relationships so that quick and Science appropriate corrective action can be taken The principles and tools used in quality man- when process controls fail. Executive management needs to clearly com- Organization and Leadership municate its commitment to quality goals and create an organizational culture that embraces The facility should be organized in a manner quality principles.

Each fa.

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In addition to ganization must be documented. Organizational trees cilities. The structure of the or. These responsi. In small fa- that suits its operations. The most appropriate way to customer complaints. Reactive feedback is ob- mum requirements. A blood bank. Data ob- lations and accreditation standards that are tained through these mechanisms should be applicable to the organization.

Customer Focus ministration of blood components. Daily shared among existing staff. Quality management system policies tween the facility and its customers. If these changes are determined to be or customer complaints and the effective. Additional information on vices are suitable for use.

A review system should address all matters related to of event data may also indicate failures to meet compliance with federal. Such an expectation should be incor- Quality oversight functions may be porated into the product specifications. Form FDA observations. If this need cannot be met. The quality management tained through customer complaints. Customers have a variety of needs and ex- nonconforming products and services.

Mecha- vice need not develop its own quality policies nisms for obtaining such feedback proactively if it is part of a larger entity whose quality include satisfaction surveys and periodic re- management system addresses all of the mini. The facility The goal is to provide an independent evalua.

The ultimate result of the orienta- tion and training program is to deem new em- An evaluation of the infrastructure and its ployees competent to independently perform limitations before implementation of proce. Space allo. Work Environment. Inadequately address- This element of the quality management sys- ing customer concerns or failing to meet ex- tem is aimed at management of personnel. Qualification requirements for person- patients.

For laboratory testing staff. A more lished to accomplish this goal. One such action could be to Human Resources change the agreement. Once hired. Time frames should be estab- ensure maximum efficiency and safety. Procedures should be in place to dards for personnel qualifications should be address the following: The facility should be position as determined by his or her educa- kept clean and well maintained so that the tion.

The orientation program should cover ment. This ployee. A formal competency plan that includes a sues. As- as the specific application of the cGMP and sessments need not be targeted to each indi- cGTP requirements as described in the facili.

CMS re- sessment of management personnel should quires that employees who perform testing also be considered. In addition. CMS requires that each of for retraining. The quality oversight personnel should testing of unknown samples. How- sure that personnel remain familiar with regu. During orientation and training. QC records.

Organizations of factors that could be considered to qualify should assess staffing effectiveness by evaluat- suppliers: Supplies may need to and 3 receipt. Examples of critical services are maintained that includes both primary suppli- infectious disease testing.

Examples of critical supplies are blood components. There should supply or service should be evaluated along be an adequate number of staff to perform the with performance relative to availability. The facility should clearly define requirements or Management should have a staffing plan that expectations for its suppliers and share this in- describes the number and qualifications of formation with staff and suppliers.

Supplier Qualification Agreements Critical supplies and services must be quali. Contracts and other agreements define expec- fied on the basis of defined requirements. Periodic reviews of agreements. The following are examples management system activities. Once suppliers are qualified. Three important ele. Critical supplies and services should bration. The be downloadd only from suppliers that have suppliers of these materials and services may been qualified. Supplies and services used in the collec.

Critical equipment may include should review contracts and agreements to en. Equipment Management plies with all applicable product standards and Equipment that must operate within defined regulations.

Exam- ment performs as intended include qualifica- ples of issues that could be addressed in an tion. The facility must define acceptance crite- ments with outside suppliers of critical mate. The con. There therapy products.

Changes should be mutually and administration of blood. Corrective action may testing. The service ment system. Receipt and inspection records managed independently. Both the contracting facility and specifications to ensure the quality of blood the contractor are legally responsible for the components. An outside supplier may be another include returning the material to the vendor or department within the same facility that is destroying it. Activities designed to ensure that equip- materials and services are addressed.

Table lists elements that acceptable parameters. The unique identifier assigned The documents developed should be re- by the manufacturer may be used. A facility using critical equipment. Recalibration and requalifica. The equip. Recalibration and requalification should man. If a menting new and making changes to existing facility believes that changes to the manufac- policies.

Each facility should have a systematic approach for identifying. Additional information functional and safety checks. After the equipment is installed.

AABB Technical Manual 18th Ed

Changes in policies. Evaluating and trending equipment the facility should have a mechanism to calibration. Such activities should include a re. See 42 CFR are reviewed at predefined periodic intervals before full implementation receives final ap. Concurrent Based on performance specifications. Retrospective quired for test performance eg. The plan Test Method Validation should include conducting the process as de- When the laboratory wishes to implement a signed.

If the laboratory develops its own meth. Modifications to a validated process may warrant revalidation. If concurrent validation is used. Development of a validation plan is best proposed changes may affect the process.

It is up to the Validation Plan facility to determine the need for revalidation Validation should be planned if it is to be effec- on the basis of its understanding of how the tive. Many facilities develop a template manufacturer be verified by the laboratory be. Although the laboratory must demonstrate that it can no single format for a validation plan is re- obtain performance specifications compara.

End-user acceptance testing may repeat some When a validation process does not pro. The hardware processes and equipment may be implement- and software interface should be designed so ed as planned or implemented with specified that staff can navigate successfully and re- limitations. The results lished by the facility and that the output and conclusions of these activities may be ap.

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It evalu- pended to the approved validation plan or ates the adequacy of equipment for use in a may be recorded in a separate document. As with process validation. If changes to the comput- Equipment Validation er system result in changes to the way a pro- Validation of new equipment used in a process cess is performed. The CLSI offers uments provide a description of or instruc. Unacceptable QC results must be investi. A well-structured document man- conformance of these products or services.

ISO provides an example of so they will recognize. QC results should be documented concurrently with performance. Documents Documents and Records Documents should be developed in a format Documentation provides a framework for that conveys information clearly and provides understanding and communicating about staff with the necessary instructions and processes throughout the organization.

Written policies. A document man- is repeated or the operational process is con. Rec- ords provide evidence of what did happen Quality Control ie. They may be mented. If products or services have been pro. The frequency for QC testing is determined by the the following items Forms provide templates for captur- ing data on paper or electronically.

AND ments required for documents. Process documents describe a comparison against a master label provides a sequence of actions and identify responsibili- mechanism for this verification. Training read. External doc. Doc- facilitates implementation and control. Each facility should have a defined pro- and handoffs between departments or work groups. The accuracy of new stock labels should be verified before this stock is put into inventory.

Many facilities maintain a master set tent. Process diagrams or flowcharts use of on-demand label printers to prevent are often used for this level of documentation. These doc. Forms should be for the required retention period. Procedures and work instructions rent. When it is not immediately evident what data should External documents that are incorporated be recorded or how to record them. The use of standardized formats helps should be provided to the staff responsible for staff know where to find specific elements and the content of new or revised documents.

Product labels. These documents provide step-by. Job ument management systems include these es- aids are excerpted from an approved docu. Change con- ties. Policies communicate the organi. If the created concurrently with the performance of equipment or software used to access archived each significant step and should clearly indi. If records are maintained electronically. Obsolete computer software that is ately and that products and services conform necessary to reconstruct or trace records to specified requirements.

Records review is an important tool to uments should be marked with the date on help evaluate the effectiveness of the quality which they were first put into use ie.

It should include document titles. Records kept in The process for managing records should this manner must meet FDA requirements for address the following items: AABB-accredited facilities are included in the trol. Records should be should also be archived appropriately.

Copies of docu. When original to ensure completeness and accuracy. It should also ability of blood components. Electronic records should be read- Records provide evidence that critical steps in able for the entire duration of their retention a procedure have been performed appropri. Electronic media such as magnetic tapes. When new or revised policies. Records adequate backups should exist in case of sys- tem failure. Specific cess descriptions. It should determine standards and regulations.

The facility should de- date. There should be a process other methods meet electronic record-keeping for controlling changes. Systems may include levels of se- ment. A method for refer. Audit trails for changed data in com. The facility should maintain a record of dicate the reason for the change.

Magnetically coded employee Electronic records must permit tracking of badges and other computer-related identify- both original and corrected data and must in. Individuals who are au- tion to frequency of their use.

It is advisable to data loss eg. The original names. The system should prevent unauthorized thorized destruction or modification. The quality management system should en- puterized systems are required by the FDA.

When data are sent manually or Considerations for electronic records in. Backup versions eg. AABB stan. The cGMP regulations require should be tested periodically to ensure that investigation and documentation of results if a the backup system remains effective. Special specific event could adversely affect patient consideration should be given to staff compe. Facility personnel should be trained to puterized data or primary sources of informa. Fatalities related to blood collection or cess should be implemented after.

CFR Regardless of their licensure and registra- ate. The CLSI has published a consensus stan- The facility should develop and maintain dard on occurrence management that ex- alternative systems to ensure access to critical plores event management in more detail. The associated processes be warranted.

The backup and recov. FDA website. The facili. De- tion are not available. Table outlines suggested com- ments. ABO group or expiration date. This requirement pertains to Program where blood collectors can report. Using the same form.

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Adverse 2 represents a deviation from cGMP. If Commission encourages reporting of sentinel several events within a relatively short period events. This system was developed had control of. The use of classification formation concerning biological product devi. The most useful schemes involve the Occasionally. The unit was not transfused. When this situation arises. See example in Table 1.

Example of an Event Classification Event: A unit of Red Blood Cells from a directed donor was issued to the wrong oncology patient. The extent of monitoring and The quality management system should de- the length of time to monitor processes de. Depending on the focus. The rationale and nature of the monitoring or problems needing corrective or planned exception should be documented. Any additional risk to the patient care system or following national trends from must be disclosed.

For smaller facilities that Careful consideration should be given to may not have sufficient data to identify trends. Reporting and monitoring of aminations to determine whether actual activ- events are essential problem identification ities comply with planned activities. Assessments are systematic ex- the occurrences. Evaluations typically include comparisons ating service demands.

The details of who or does not happen after a process is or is not performs the assessments and how they are performed. Early detection of trends makes it possible to develop preventive The activities of blood usage review commit- actions before patient safety. The number of incorrect test result performed should be addressed. Single and quality oversight personnel for any defi.

These thresholds can be determined from reg- In addition. Process-based indicators measure the Internal assessments may include evaluations degree to which a process can be consistently of quality indicator data. In control sessed as well as to executive management. Statistical oversight personnel should track progress to. In a run chart. These assessments should dicators are often used to measure what does be planned and scheduled.

Quality limits result from special causes. The root cause should be de- To make the best use of these assess- termined. Assessments reports is an example of such an indicator. The results should be docu. Guidelines are avail- fected. Quality Indicators Assessments can be internal or external Quality indicators are performance measures and can include quality assessments.

Evaluation summaries provide infor. Outcome-based in- related processes. For should cover the quality system and the major each indicator. An example of a process-based in- single process. These indicators can be process based or outcome Internal Assessments based.

To prepare. External Assessments priate transfusions and are based on measur- External assessments include inspections. In the preparation phase. For most external dations.

Additional assess. Transfusion services should those not affiliated with the organization. When no approved PT therapeutic apheresis.

As a condition for certification. Transfusion audits provide reviews of pol- icies and practices to ensure safe and appro. CMS releases of directed donor units. After the assessment. Audits assess a fa- health departments. Proficiency testing PT is one means for deter- Other assessments important in transfusion mining that test systems including methods.

During the assessment phase. Effec- sion and cellular therapies and clinical diag- tive corrective and preventive action cannot nostics. The process of develop- interim remedial action. Quality oversight personnel should thought of as a proactive approach to address monitor the PT program and verify that test the underlying causes of anticipated prob- systems are maintained in a state of control lems identified through the analysis of data and appropriate corrective action is taken and information.

PT samples should provement are outlined in Table The importance of identifying. This process should also include evaluation of Sources of information for process improve- near-miss events and a mechanism for data ment activities include process deviations.

Supervisory can be thought of as a reactive approach to ad- review of the summary evaluation report dress the root causes of actual nonconfor- should be documented along with investiga. Pending such gating. Corrective action dling patient or donor specimens.

See comparisons in Table Preventive action is defined as action ing the active survey period. In transfu- cause. By examining this picture. Such an analysis is important to process as well as to give a pictorial represen- avoid tampering with processes that are mere.

A chart of causes. These pro. The underlying causes of an undesirable methods. An example of a lyzed to determine their scope. Those that occur most frequently are used to work backward through the process. The more complex the latent failures. An example of a Pareto chart is missing information.

The cause- annually in which data from all these sources are aggregated and analyzed can be valuable and-effect diagram.

A process flowchart Most problems. When using the cause-and-effect little effect. Comparison of Remedial. Active failures are those that problem and the more involved the process. Three commonly used with potential for damage that may lie dor- tools for identifying underlying causes in an mant and become evident only when triggered objective manner are process flowcharting.

A method ties and important decision points within that that can be of use when such problems occur process. Latent fail- the greater the need to enlist a team and to for.

Once solutions have been successful- evaluated relative to organizational con- ly tested. After straints and should be narrowed down to implementation. They should be consulted when possible solu- tions are being considered.

Example of a cause-and-effect diagram. Brainstorming and process flowcharting posed change. Possible solutions should be the trial. Data can be collected using the can be particularly helpful in this phase. Individuals least periodically to ensure the continuing ef- who implement the process are usually the fectiveness and control of the changed pro- most knowledgeable about what will work.

Identification and Evaluation of scale solutions can be tried on a limited basis Solutions and can be expanded if successful. Data should be collect- during the creative phase of process improve- ed to evaluate the effectiveness of the pro- ment. Solutions may fail if representatives with sible failures within a process. Despite their relative tives. Six Sigma uses the data-driven tions. Additional information about both approach to problem solving of define. Six Sigma emphasizes precision cut time.

LEAN emphasizes speed improve performance. Organization and Leadership. Example of a Pareto chart. American Society for Quality. Title Suppliers of critical materials and services ie. US Government Critical equipment may include instruments.

Customer Focus. Quality management of all personnel addresses adequate staffing levels and staff selection. Procedures related to general safety. Management of Nonconforming Events. Data integrity should be assessed periodically and backup devices. This equipment must be uniquely identified and op- erate within defined specifications.

Process Improvement.

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Documents and Records. Opportunities for improvement may be identified from deviation reports. Quality organizations should understand and meet or exceed customer needs and expectations. Code of federal regulations. CFR Parts and All critical materials should be qualified and then inspected and test- ed upon receipt to ensure that specifications are met. Process improvement includes determination of root causes.

Deviations from facility-defined requirements. Information Management. Suppliers and Materials Management. Monitoring and Assessment. These needs and expectations should be defined in a contract. Process Management. A systematic approach to develop new. CFR Parts 2. US Printing Office. US Government Print. Human Resources. Evaluation of facility processes includes internal and external assessments. Unauthorized access. Validation must be planned and re- sults reviewed and accepted. Documents include policies.

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Now customize the name of a clipboard to store your clips. Visibility Others can see my Clipboard.There should supply or service should be evaluated along be an adequate number of staff to perform the with performance relative to availability. Back to Technical Manual, 19th Edition — Print. AND ments required for documents. Blood must be protected tal surfaces and equipment.

Using the American Rare Donor Program 4. CFR Parts 2. These pro.