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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.
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. 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. For additional information. 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.
Free read the complete collection of user manuals and ebooks
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.
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.
AABB Technical Manual 18th Ed
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. 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. Space al- location. Equipment Management. Records provide evidence that the process was performed as intended and allow assessment of product and service quality. Baldrige Performance Excellence Program. Medical laboratories— cation. Foundation for the Accreditation of Cellular Health care criteria for performance excel. Joint Com. Food and Drug Administration. CBER Office Silver 6.
Joint tion. Clinical and Laboratory Standards Institute. ISO Santrach PJ. Sil- CFR Part and Silver Spring. Judith Levitt. General prin- standards. Quality program implementation. Guidance for lated deaths. Hospital accreditation Laboratory accredita.
National Institute of munication. July The Joint Commission. Center for Bio- industry: Quality systems approach to phar. Commission Resources. Quality Management System: Development Quality management system: A model for lab- and management of laboratory documents. Juran JM. New York: Godfrey AB. Laboratory US Govern. Moore SB. Quality in action. Standards for cellular therapy industry: Blood establishment computer sys- services.
Final guidance mission Resources. Guideline for International Organization for Standardiza. Process validations: General princi- ment. College of American Pathologists. ASQ Fontaine M.
CFR Parts Notifying FDA of fatalities related to Motschman TL. Guidance for 7. Guidance for of Communication. Requirements for quality and competence. Association donation fatalities: Notification process for bulletin Oakbrook Terrace.
Woods LL. Duckett JB. Standards for blood banks Spring. Standards and Technology. Corrective versus preventive MJ.
Introducing the big Q: Picukaric ing the loop on the audit process.
Strauss RG. Guidance for blood utilization. Waxman D. Association Medicine Section Coordinating Committee. So many tools. Monitoring transfusionist practices: A waukee. ASQ Quality Press. Mil- JM.
Vaichekauskas L. Guidelines for patient blood management and Derdiarian AK. Carpenter-Badley J. Reporting donor fatalities. National ing for blood and plasma establishments Oc. AuBuchon J. Learn about Transfusion Transfusion Biological product deviation report. Biological Mil- ing Office. Lohr K. After the quality audit: Clos- Biovigilance initiatives.
Walters L. Shulman IA. Hume H. Whitaker B.
Roback J. Strong DM. AABB News You need the tools to do the product deviations: Includes human tissue and job. The quality toolbox. Russell JP. Kuehnert Center Press.
Regel T. Blanchette VS. Tague NR. Control chart A graphic tool used to determine whether the distribution of data values gener- ated by a process is stable over time.
Process control Activities intended to minimize variation within a process to produce a predict- able output that meets specifications. Near-miss event An unexpected occurrence that did not adversely affect the outcome but could have resulted in a serious adverse event. Change control Established procedures for planning. Design output Documents.
An employee may be qualified on the basis of technical. End-product test and Verification through observation. Calibration Comparison of measurements performed with an instrument to those made with a more accurate instrument or standard for the purpose of detecting. Such proce- dures include the submission. Design output should identify characteristics of a product or service that are crucial to safety and function and to meeting regulatory requirements.
Formal change control provides a measure of stability and safety and avoids arbitrary changes that might affect quality. The most widely accepted formula for process capability is Six Sigma. A control chart plots a statistic vs time and helps to determine whether a process is in control or out of control according to defined criteria eg.
Qualification Demonstration that an entity is capable of fulfilling specified requirements and verification of attributes that must be met or complied with for a person or thing to be considered fit to perform a particular function. Exam- ples of design output include standard operating procedures.
It should contain or make reference to acceptance criteria. Process capability Ability of a controlled process to produce a service or product that fulfills requirements or a statistical measure of the inherent process variability for a given characteristic relative to design specifications.
Specifications are often in the form of written descriptions. Quality management The organizational structure. Quality control Operational techniques and activities used to monitor and eliminate causes of unsatisfactory performance at any stage of a process. Verification Confirmation. Requirements can include things that the system or product must do. Validation Demonstration through objective evidence that the requirements for a particular application or intended use have been met.
Quality indicators are used to monitor progress toward stated quality goals and objectives. Specification Description of a set of requirements to be satisfied by a product. Quality indicators Measurable aspects of processes or outcomes that provide an indication of the condition or direction of performance over time. Validation provides assurance that new or changed processes and procedures are capable of consistently meeting specified requirements before implementation.
Requirement A stated or obligatory need or expectation that can be measured or observed and that is necessary to ensure quality. Quality manage- ment includes strategic planning. Blood Drugs Tissues. Title 21 Topic Biologics.
At a minimum. Depending on the operational and performance qualification methodology. Once a record of appropriate in-range QC results has been established during either equipment qualification or the ongoing QC. For any new piece of equipment. After the equipment has been suitably qualified for use.
It should be designed and managed The AABB requires its accredited facilities in a way that meets operational needs and to plan. North Carolina The authors have disclosed no conflicts of interest. Susan L. All employees are re.
Uni- versity of Cincinnati. The to minimize risks to the health and safety of layout of the physical space. Appendix also lists rele- protective equipment. Vice President for Quality and Regulatory Affairs. Such a program also in. Chemical fume hoods methods. Staff handling hazard- Clean Rooms ous materials must have ready access to hand- washing sinks. Work surfaces and equipment performed. Housekeeping ovated space. In some cases. The National Electrical Code is cluding architectural and construction safety routinely used as a national guideline for the considerations.
The location of very heavy commodated in a BSC. Adequate space must be allotted should be regularly cleaned and disinfected. Facility design. Emergency International standards for clean rooms backup power sources.
Clean-room facilities should be considered for cial water sources for reagent preparation open processing activities that cannot be ac- must be provided. Environmental monitoring systems should be Effective design and maintenance of facilities considered for laboratories that require posi- along with the physical organization of work tive or negative air pressure differentials or activities can help reduce or eliminate many where air filtration systems are used to control potential hazards.
The workplace should be kept clean and free sidered in the context of the processes to be of clutter. American Society of Heating. The nationally accepted specifi- and maintenance also affect process efficien. During the design phase for a new or ren. Exits and fire safety equipment tasks eg. Housekeeping responsibilities. The number and location of eyewash fectiveness are essential to safe operations. The contents of ible power supplies and backup generators.
Laboratories that pro- equipment.
Written procedures. Mobile Sites tions for general manufacturing applications Mobile blood collection operations can pre- to limit airborne particulates.
Technical work areas might be con. For dance with local regulations for medical waste. Consideration in physical design should be isotopes. Risk areas can be stratified. An advance safety sur- and pollutants. Hand-washing access is essential at col- Restricted Areas lection sites.
Guidelines for restricted access tors may contribute to employee fatigue. Portable Health Administration OSHA and Nuclear screens and crowd-control ropes are helpful in Regulatory Commission NRC standards so directing traffic flow to maintain safe work ar- that personnel entering or working around eas. Blood-contaminated waste must be not normally assigned to these areas should either returned to a central location for dispos- receive adequate training to avoid endanger. Several fac- restricted.
All ing validated equipment. Food service areas should be physically them are aware of existing biological. Carpeted or difficult-to-clean Hazardous areas should be clearly and uni. A safety plan safety program: This plan identifies needed. Both the total time per work shift and the procedures. Actions to correct problems associ. Most obvious is the safety of techni- eliminate the underlying cause. Safety training must precede even injuries.
Supervisors are responsible for assessing and documenting each employ. Table lists Basic Elements of a Safety Program topics to cover in work safety training pro- Training grams. Embed Size px. Start on. Show related SlideShares at end. WordPress Shortcode. JeffreyGarcia41 Follow. Published in: Full Name Comment goes here. Are you sure you want to Yes No. Be the first to like this. No Downloads.
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File ID: You just clipped your first slide!End-user acceptance testing may repeat some When a validation process does not pro. Managing Hazardous Chemical Spills. CBER Office Activities designed to ensure that equip- materials and services are addressed. The Joint Commission. Procedures should be in place to dards for personnel qualifications should be address the following: