The facility should be position as determined by his or her educa- kept clean and well maintained so that the tion, training, experience, certifications, and products and services provided are not com- licensure. For laboratory testing staff, the stan- promised. Procedures should be in place to dards for personnel qualifications should be address the following: compatible with the regulatory requirements established under CLIA.

Effective job de- Biological safety eg, protection from blood- scriptions clearly define the qualifications and borne pathogens. Fire safety. Radiation safety, if applicable. Orientation, Training, and Competence Discard of biologic and other hazardous Assessment substances. Once hired, employees should be oriented to their position and the organizations policies cGMP regulations require quality plan- and procedures and be trained in their new ning and control of the physical work environ- duties.

The orientation program should cover ment, including the following: facility-specific requirements and policies that address issues such as safety, quality, informa- Adequate space and ventilation. The Sanitation and trash disposal. Training should be provided for Water systems. 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- the duties and responsibilities defined in their dures or installation of equipment will help job descriptions.

Time frames should be estab- ensure maximum efficiency and safety. A more lished to accomplish this goal. During orientation and training, employees Performance of instrument maintenance should be given the opportunity to ask ques- and function checks. Monitoring of the recording and reporting All aspects of the training should be docu- of test results. Assessment of FDA cGMP training is required for staff Test performance by testing previously involved in the manufacture of blood and analyzed specimens, internal blind test- blood products, including staff involved in col- ing samples, or external proficiency test- lection, testing, processing, preservation, stor- ing samples.

As- as the specific application of the cGMP and sessments need not be targeted to each indi- cGTP requirements as described in the facili- vidual test or procedure performed by the em- tys own written operating procedures. This ployee; instead, they can be grouped together training should be provided periodically to en- to assess similar techniques or methods. How- sure that personnel remain familiar with regu- ever, any test with unique aspects, problems, latory requirements.

CMS re- sessment of management personnel should quires that employees who perform testing also be considered. In addition, Direct observations of The Joint Commission requires analyses of ag- Routine patient test performance in- gregate competence assessment data to iden- cluding patient preparation, if applica- tify staff learning needs. Staffing that they are reliable sources of materials. 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.

Suppliers personnel needed to perform the facilitys ability to consistently meet specifications for a functions safely and effectively. There should supply or service should be evaluated along be an adequate number of staff to perform the with performance relative to availability, deliv- operational activities and support quality ery, and support.

The following are examples management system activities. Organizations of factors that could be considered to qualify should assess staffing effectiveness by evaluat- suppliers: ing human resource indicators eg, overtime, staff injuries, and staff satisfaction in con- Licensure, certification, or accreditation. The results of this evaluation should Results of audits or inspections.

Experience with that supplier. Cost of materials or services. Suppliers and Materials Management Delivery arrangements. Materials, supplies, and services used as in- Financial security, market position, and puts to a process are considered critical if they customer satisfaction.

Examples of critical supplies are blood components, blood bags, test kits, and A list of approved suppliers should be reagents. Examples of critical services are maintained that includes both primary suppli- infectious disease testing, blood component ers and suitable alternatives for contingency irradiation, transportation, equipment cali- planning. Critical supplies and services should bration, and preventive maintenance.

The be purchased only from suppliers that have suppliers of these materials and services may been qualified. Once suppliers are qualified, be internal eg, other departments within the periodic evaluations of supplier performance same organization or external outside ven- help ensure suppliers continued ability to dors.

Supplies and services used in the collec- meet requirements. Tracking suppliers ability tion, testing, processing, preservation, storage, to meet expectations gives the facility valuable distribution, transport, and administration of information about the stability of each suppli- blood components, cellular therapy products, ers processes and commitment to quality.

Three important ele- tification of the supplier, quality oversight per- ments of supplier and materials management sonnel, and management with contracting are 1 supplier qualification; 2 agreements; authority, if applicable. Supplies may need to and 3 receipt, inspection, and testing of in- be replaced or quarantined until all quality is- coming supplies. Supplier Qualification Agreements Critical supplies and services must be quali- Contracts and other agreements define expec- fied on the basis of defined requirements.

Sim- tations and reflect the concurrence of the par- ilarly, suppliers should be qualified to ensure ties involved. Changes should be mutually and administration of blood, components, tis- agreed upon and incorporated as needed. Corrective action may testing. An outside supplier may be another include returning the material to the vendor or department within the same facility that is destroying it.

Receipt and inspection records managed independently, or it may be another enable the facility to trace materials that have facility eg, contract manufacturer. The con- been used in a particular process and provide tracting facility assumes responsibility for the information for ongoing supplier qualifica- manufacture of the product; ensuring the safe- tion. Both the contracting facility and specifications to ensure the quality of blood the contractor are legally responsible for the components, cellular therapy products, tis- work performed by the contractor.

The service ment system. Critical equipment may include should review contracts and agreements to en- instruments, measuring devices, and comput- sure that all important aspects for their critical er systems hardware and software.

Activities designed to ensure that equip- materials and services are addressed. Exam- ment performs as intended include qualifica- ples of issues that could be addressed in an tion, calibration, maintenance, and monitor- agreement or contract include the responsibil- ity for a product or blood sample during ship- ing.

Calibration, functional and safety checks, ment; the suppliers responsibility to promptly and preventive maintenance should be sched- notify the facility when changes have been uled and performed according to the manu- made that could affect the safety of blood facturers recommendations and regulatory re- components, cellular therapy products, tis- quirements of the FDA and CMS.

Receipt, Inspection, and Testing of When one selects new equipment, it is important to consider not only the perfor- Incoming Supplies mance of the equipment as it will be used in Before acceptance and use, critical materials the facility but also any issues regarding ongo- such as reagents, blood components, cellular ing service and support by the supplier.

There therapy products, tissues, and derivatives should be a written plan for installation, oper- should be inspected and tested if necessary ational, and performance qualifications. After the equipment is installed, any prob- Performance measures. Recalibration and requalifica- Current knowledge eg, of other successful tion may be necessary if repairs are made that practices. Recalibration and requalification should man, materials, and equipment.

The facility must develop a mechanism to Documents needed for the new or changed uniquely identify and track all critical equip- process es.

The unique identifier assigned The documents developed should be re- by the manufacturer may be used, or a unique viewed by management personnel with direct identification code may be applied by the authority over the process and by quality over- transfusion or cellular therapy service or sight personnel before implementation.

Maintain- Changes in policies, processes, and proce- ing a list of all critical equipment helps in the dures should be documented, validated, re- control function of scheduling and performing viewed, and approved.

Additional information functional and safety checks, calibrations, pre- on policies, processes, and procedures can be ventive maintenance, and repair. The equip- found in the Documents and Records sec- ment list can be used to ensure that all appro- tion later in this chapter. Evaluating and trending equipment the facility should have a mechanism to calibration, maintenance, and repair data help ensure that procedures are performed as de- the facility assess equipment functionality, fined and that critical equipment, reagents, manage defective equipment, and identify and supplies are used in conformance with equipment needing replacement.

When manufacturers written instructions and facili- equipment is found to be operating outside ty requirements. Table lists elements that acceptable parameters, the potential effects constitute sound process control among oth- on the quality of products or test results must er elements of a quality management system. A facility using critical equipment, reagents, or Process Management supplies in a manner that is different from the manufacturers directions should validate such Written and approved policies, processes, and use.

Each facility should have a systematic approach for identifying, planning, and imple- see 21 CFR If a menting new and making changes to existing facility believes that changes to the manufac- policies, processes, and procedures that affect turers directions would be appropriate, it the quality of the facilitys tests, products, or should encourage the manufacturer to make services.

Such activities should include a re- such changes in the labeling ie, the package view of at least the following: insert or user manual. Process Validation specifications before reporting patient results. However, even when effective Reference intervals normal values. Prospective validation is used Any other performance characteristic re- for new or revised processes. Retrospective quired for test performance eg, specimen validation may be used for processes that are or reagent stability.

Concurrent Based on performance specifications, the validation is used when required data cannot laboratory must also establish calibration and be obtained without performance of a live control procedures and document all activities process.

If concurrent validation is used, data for test method validation. See 42 CFR are reviewed at predefined periodic intervals before full implementation receives final ap- Modifications to a validated process may warrant revalidation, depending on the nature and extent of the change.

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. Development of a validation plan is best proposed changes may affect the process. The plan Test Method Validation should include conducting the process as de- When the laboratory wishes to implement a signed.

Additionally, a significant amount of nonwaived test using an FDA-approved or effort should be targeted at attempts to -cleared test system, CLIA requires that the break the process to identify weaknesses and performance specifications established by the limitations. Many facilities develop a template manufacturer be verified by the laboratory be- for the written validation plan to ensure that fore it reports patient results.

Although the laboratory must demonstrate that it can no single format for a validation plan is re- obtain performance specifications compara- quired, most plans include the following com- ble to those of the manufacturer for accuracy, mon elements: precision, reportable range, and reference in- tervals normal values.

System description. If the laboratory develops its own meth- Purpose or objectives. The validation plan should be reviewed its and specifications supplied by the and approved by quality oversight personnel manufacturer.

Performance qualification demonstrates Staff responsible for carrying out the vali- that the equipment performs as expected dation activities should be trained in the pro- for its intended use in the processes estab- cess before the plan is executed. The results lished by the facility and that the output and conclusions of these activities may be ap- meets the facilitys specifications.

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.

This specific process that uses the facilitys own documentation typically contains the follow- personnel, procedures, and supplies in a ing elements: normal working environment. Expected and observed results.

Testing by the com- Approval signatures. Implementation timeline. End-user acceptance testing may repeat some When a validation process does not pro- of the validation performed by the developer, duce the expected outcome, its data and cor- such as load or stress testing and verification rective actions must be documented as well.

In addition, the end user should evalu- should provide final review and approval of ate the ability of personnel to use the the validation plan, results, and corrective ac- computer system as intended within the con- tions and determine whether new or modified text of actual work processes. 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.

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, process revalidation should should include installation, operational, and also be performed. As with process validation, performance qualifications, as follows quality oversight personnel should review and approve validation plans, results, and Installation qualification demonstrates that corrective actions and should determine wheth- the instrument is properly installed in envi- er implementation may proceed with or with- ronmental conditions that meet the manu- out limitations.

For additional information, facilities Operational qualification demonstrates should refer to FDA guidance on computer that the installed equipment operates as in- system validation in the users facility. Rec- ords provide evidence of what did happen Quality Control ie, that a process was performed as intend- ed , and provide information needed to as- QC testing is performed to ensure the proper sess product and service quality.

Together, functioning of materials, equipment, and documents and records are used by quality methods during operations. QC performance oversight personnel to evaluate the effective- expectations and acceptable ranges should be ness of a facilitys policies, processes, and defined and be made readily available to staff procedures.

ISO provides an example of so they will recognize, and respond appropri- quality system documentation that includes ately to, unacceptable results and trends. The frequency for QC testing is determined by the the following items facility in accordance with the applicable The quality policy and objectives. QC results should be documented concurrently with performance. Documented procedures for the control of QC testing should include the following: documents, records, and nonconforming Identification of personnel performing the products and for corrective action, preven- test.

Identification of reagents including lot Records related to the quality management numbers and expiration dates. Testing date and, when applicable, time. All other documents needed by the organi- Results. Written policies, process descriptions, procedures, work instructions, job aids, labels, Unacceptable QC results must be investi- forms, and records are all part of the facilitys gated and corrective action must be imple- document management system.

They may be mented, if indicated, before the QC procedure paper based or electronic. A document man- is repeated or the operational process is con- agement system provides assurance that doc- tinued. If products or services have been pro- uments are comprehensive, current, and vided since the last acceptable QC results were available and that records are accurate and obtained, it may be necessary to evaluate the complete.

A well-structured document man- conformance of these products or services. 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.

Doc- templates for recording data. The CLSI offers uments provide a description of or instruc- guidance regarding general levels of tions regarding what is supposed to happen. Policies communicate the organi- the requirements in a document management zations highest-level goals, objectives, and in- system. Many facilities maintain a master set tent. The rest of the organizations documenta- of labels that can be used as a reference to veri- tion interprets, and provides instructions fy that only currently approved stock is in use.

Process documents describe a comparison against a master label provides a sequence of actions and identify responsibili- mechanism for this verification. Change con- ties, decision points, requirements, and accep- trol procedures should be established for the tance criteria.

Process diagrams or flowcharts use of on-demand label printers to prevent are often used for this level of documentation. Each facility should have a defined pro- and handoffs between departments or work groups. These documents provide step-by- review and approval of new or revised docu- step directions on performing job tasks and ments; a method for keeping documents cur- procedures.

Procedures and work instructions rent; a process for control of document distri- should include enough detail to perform a task bution; and a process for archiving, protecting, correctly but not so much as to be difficult to and retrieving obsolete documents. Training read. 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.

Doc- facilitates implementation and control. Job ument management systems include these es- aids are excerpted from an approved docu- tablished processes: ment and condense information into a short- er, more readily viewable format. External doc- Verifying the adequacy of the document be- uments eg, from a manufacturers manual or fore its approval and issuance. Forms provide templates for captur- ing data on paper or electronically. These doc- tions in which they will be used.

Retaining and retrieving previous versions uments specify the data requirements called for in SOPs and processes. Forms should be for the required retention period. Preventing unintended use of outdated or carefully designed to be easy to use, minimize obsolete documents.

When it is not immediately evident what data should External documents that are incorporated be recorded or how to record them, forms by reference become part of the document should include instructions for their use. Retention periods. When new or revised policies, process de- Confidentiality. The facility should de- date. It should determine standards and regulations.

Specific cess descriptions, procedures, forms, and la- requirements for records to be maintained by bels is useful for maintaining document con- AABB-accredited facilities are included in the trol. It should include document titles, relevant AABB standards. It should also ability of blood components, cellular therapy identify the number and locations of con- products, tissues, and derivatives as required trolled copies in circulation.

Copies of docu- by federal regulations. If records are maintained electronically, Records adequate backups should exist in case of sys- tem failure. 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- period.

Obsolete computer software that is ately and that products and services conform necessary to reconstruct or trace records to specified requirements. Records should be should also be archived appropriately. If the created concurrently with the performance of equipment or software used to access archived each significant step and should clearly indi- data cannot be maintained, the records should cate the identity of the individuals who per- be converted to another format or copied to formed each step and when each step was another medium to permit continued access.

When original to ensure completeness and accuracy. Records kept in The process for managing records should this manner must meet FDA requirements for address the following items: electronic record-keeping. Creation and identification of records.

The medium selected should be appropriate Protection from accidental or unauthorized to comply with the retention requirements. Each facility must have a policy for alter- Verification of completeness, accuracy, and ing or correcting records.

The original names; inclusive dates of employment; and wording must not be obliterated in written corresponding signatures, identifying initials, records; the original may be crossed out with a or identification codes of personnel autho- single line, but it should remain legible. Write- rized to create, sign, initial, or review reports overs and scratch-outs should not be used.

Magnetically coded employee Electronic records must permit tracking of badges and other computer-related identify- both original and corrected data and must in- ing methods are generally accepted in lieu of clude the date and identity of the person who written signatures, provided that the badges or made the change.

There should be a process other methods meet electronic record-keeping for controlling changes. A method for refer- requirements. Audit trails for changed data in com- The quality management system should en- puterized systems are required by the FDA. Privacy of patient and donor records should be addressed to maintain the Storage of records in a manner that protects security and confidentiality of such records.

Individuals who are au- tion to frequency of their use. Systems may include levels of se- ment, such as computer hardware, and curity defined by job responsibility and re- software to view archived records.

Retention of original color-coded records Periodic integrity checks should be conducted when only black-and-white reproductions to ensure that critical data have not been inad- are available. When data are sent manually or Considerations for electronic records in- electronically from one point to another, a clude the following: process should be in place to ensure that the data accurately and reliably reach their final A method of verifying the accuracy of data destination in a timely manner.

Backup versions eg, disks, tapes, or du- Prevention of unintended deletion of data plicate hard copies of critical data should be or access by unauthorized persons. It is advisable to data loss eg, when a storage device is full. Envi- basis of investigations and root cause anal- ronmental conditions in the backup storage yses.

Tem- data about events and their causes. Archival copies of computer Evaluate effectiveness of the corrective ac- operating systems and applications software tions and preventive actions taken. 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.

De- tion are not available. The backup and recov- pending on the severity of an event and risk to er y procedures for computer downtime patients, donors, and products as well as the should be defined, and validation documenta- likelihood of recurrence, investigation of con- tion should show that the backup system tributing factors and underlying causes may works properly.

The associated processes be warranted. 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- safety or the safety, purity, or potency of blood tence and readiness to use the backup system.

A summary of each event, investiga- tions from accepted policies, processes, and tion, and any follow-up activities must be procedures or in failures to meet require- prepared. Table outlines suggested com- ments, as defined by the facility, AABB stan- ponents of an internal event report.

The facili- ly. Who Reporting individual s Individual s involved by job title in committing, compounding, discovering, investi- gating, and initiating any immediate action Patient or donor identification code Reviewer s of report What Brief description of event Effects on and outcomes for patient, donor, blood component, or tissue Name of component and unit identification number Manufacturer, lot number, and expiration dates of applicable reagents and supplies Immediate actions taken When Date of report Date and time event occurred Date and time of discovery Date and time, if applicable that immediate action was taken.

Units released from donors who are or should have been either temporarily or permanently deferred because of their medical history or a history of repeatedly reactive viral marker tests. Shipment of a unit with repeatedly reactive viral markers.

Units released from donors for whom test results were improperly interpreted because of testing errors related to improper use of equipment. Units released before completion of all tests except as an emergency release. Sample used for compatibility testing that contains incorrect identification. Testing error that results in the release of an incorrect unit. Incorrectly labeled blood components eg, ABO group or expiration date.

Incorrect crossmatch label or tag. Storage of biological products at an incorrect temperature. Microbial contamination of blood components when the contamination is attributed to an error in manufacturing. Adverse 2 represents a deviation from cGMP, estab- transfusion reactions and events or incidents lished specifications, or applicable regula- can be reported voluntarily to the Centers for tions or standards or that is unexpected or un- Disease Control and Prevention CDC Nation- foreseen; 3 may affect the products safety, al Healthcare Safety Network NHSN Hemo- purity, or potency; 4 occurs while the facility vigilance Module.

This system was developed had control of, or was responsible for, the through a public-private collaboration that in- product; and 5 involves a product that has left cluded the Department of Health and Human Services and its agencies, and the private sec- the facilitys control ie, has been distributed. This requirement pertains to Program where blood collectors can report, events that are unexpected or unforeseeable analyze, and benchmark adverse donor reac- but may relate to the transmission or potential tions.

The use of classification formation concerning biological product devi- schemes may facilitate trend analysis and typi- ation reporting can be found on the FDA web- cally involves one or more of the following cat- site. The most useful schemes involve the Occasionally, there may be a need for a fa- use of multiple categories for each event, cility to deviate from approved procedures to which allows data to be sorted in a variety of meet the unique medical needs of a particular ways so that patterns that were previously not patient.

When this situation arises, a medically obvious can emerge. See example in Table 1- indicated exception should be planned and 3. Such sorting or stratification can result in approved in advance by the facilitys medical identification of situations that require closer director. The rationale and nature of the monitoring or problems needing corrective or planned exception should be documented.

For smaller facilities that Careful consideration should be given to may not have sufficient data to identify trends, maintaining a controlled process and verifying pooling data with a larger entity eg, the labo- the safety and quality of the resulting product ratory or all transfusion services in a health- or service. Any additional risk to the patient care system or following national trends from must be disclosed.

The extent of monitoring and The quality management system should de- the length of time to monitor processes de- scribe how the facility monitors and evaluates pends on the frequency and critical aspects of its processes.

Assessments are systematic ex- the occurrences. Reporting and monitoring of aminations to determine whether actual activ- events are essential problem identification ities comply with planned activities, are imple- methods for process improvement activities in mented effectively, and achieve objectives.

Depending on the focus, assessments can. Event: A unit of Red Blood Cells from a directed donor was issued to the wrong oncology patient. The unit was not transfused. Event Classification Type of event: patient Procedure involved: issuing products Process involved: blood administration Product involved: Red Blood Cells Location: transfusion service Other factors: directed donor Other factors: oncology patient.

Underlying Causes Proximate cause: two patients with similar names had crossmatched blood available Root cause: inadequate procedure for verification of patient identification during issue. Outcome Severity: serious, FDA reportable Patient: no harm, correct product was obtained and transfused Product: no harm, product returned to inventory Donor: not applicable. Successful Barriers Problem detected during the patient identification verification step of blood administration.

Quality Indicators Assessments can be internal or external Quality indicators are performance measures and can include quality assessments, peer re- designed to monitor one or more processes views, self-assessments, and proficiency test- during a defined time and are useful for evalu- ing.

Evaluations typically include comparisons ating service demands, production, personnel, of actual to expected results. These indicators can be process based or outcome Internal Assessments based. Process-based indicators measure the Internal assessments may include evaluations degree to which a process can be consistently of quality indicator data, targeted audits of a performed. An example of a process-based in- single process, or system audits that are dicator is turnaround time from blood product broader in scope and may cover a set of inter- ordering until transfusion.

Outcome-based in- related processes. These assessments should dicators are often used to measure what does be planned and scheduled. The details of who or does not happen after a process is or is not performs the assessments and how they are performed.

The number of incorrect test result performed should be addressed. Assessments reports is an example of such an indicator. For should cover the quality system and the major each indicator, thresholds are set that repre- operating systems in the donor center and sent warning limits, action limits, or both. These thresholds can be determined from reg- In addition, there should be a process for ulatory or accreditation requirements, bench- responding to the issues raised as a result of marking, or internal facility data.

The results should be docu- ity indicator data are run charts and control mented and submitted to management per- charts. In a run chart, time is plotted on the sonnel who have authority over the process as- x-axis and values on the y-axis.

In control sessed as well as to executive management. Single and quality oversight personnel for any defi- points outside the upper and lower control ciencies noted in the assessment. Quality limits result from special causes. Statistical oversight personnel should track progress to- rules for interpreting consecutive points out- ward implementation of corrective actions side 1 standard deviation SD , 2 SDs, and 3 SDs should be used to recognize a process that and monitor them for effectiveness.

The root cause should be de- To make the best use of these assess- termined, and corrective action should be ini- ments, there should be a process to track, tiated, if indicated.

Early detection of trends makes it possible to develop preventive The activities of blood usage review commit- actions before patient safety, blood, compo- tees in the transfusion setting are an example nents, tissues, or derivatives are adversely af- of internal assessment. Guidelines are avail- fected.

Evaluation summaries provide infor- able from the AABB for both adult and pediat- mation that is useful for addressing individual ric utilization review. Transfusion audits provide reviews of pol- icies and practices to ensure safe and appro- External Assessments priate transfusions and are based on measur- External assessments include inspections, sur- able, predetermined performance criteria.

Audits assess a fa- health departments. Participation in an exter- cilitys performance and effectiveness in the nal assessment program provides an indepen- following6: dent objective view of the facilitys performance.

External assessors often bring broad-based ex- Ordering practices. Such assessments are increas- Sample collection and labeling. Near-miss events. In the preparation phase, there is typically Usage and discard. To prepare, facilities can perform inter- Ability of services to meet patient needs. For most external dations. During the assessment phase, it is impor- One method of assessing the blood ad- tant to know who is responsible for the asses- ministration process is to observe a predeter- sors or inspectors while they are in the facility.

After the assessment, and practice may include reviews of transfu- identified issues should be addressed. Usually, sion reactions and transfusion-transmitted a written response is submitted. The review committee may monitor policies and practices for notifying recipients Proficiency Testing for Laboratories or recipients physicians of recalled products and notifying donors of abnormal test results. Proficiency testing PT is one means for deter- Other assessments important in transfusion mining that test systems including methods, practice include reviews of policies for in- supplies, and equipment are performing as formed consent, indications for transfusion, expected.

As a condition for certification, CMS releases of directed donor units, and outpa- requires laboratories to participate successful- tient or home transfusions. Additional assess- ly in an approved PT program for CLIA- ments should include, where appropriate, 1 regulated testing. When no approved PT therapeutic apheresis; 2 use of blood recov- program exists for a particular analyte, the lab- ery devices; 3 procurement and storage of he- oratory must have another means to verify the matopoietic progenitor cells; 4 perioperative accuracy of the test procedure at least twice autologous blood collection; 5 procurement annually.

PT must be performed using routine work American Society for Quality. PT samples should provement are outlined in Table However, a en to address the root causes of an existing CLIA-certified laboratory is prohibited from nonconformance or other undesirable situa- discussing the PT or sending the samples to a tion to reduce or eliminate the risk of recur- laboratory with a different CLIA number dur- rence.

Preventive action is defined as action ing the active survey period, even if the two taken to reduce or eliminate the potential for a laboratories are within the same organization nonconformance or other undesirable situa- and that would be the routine manner for han- tion to prevent occurrence.

Corrective action dling patient or donor specimens. 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- mances, deviations, complaints, and process tion and corrective action for unacceptable re- failures, whereas preventive action can be sults.

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. In transfu- cause. See comparisons in Table Effec- sion and cellular therapies and clinical diag- tive corrective and preventive action cannot nostics, this goal is tied to patient safety goals be implemented until the underlying cause is and expectations for the highest quality health determined and the process is evaluated in re- care.

The importance of identifying, investi- lationship to other processes. Pending such gating, correcting, and preventing problems evaluation, it may be desirable to implement cannot be overstated. The process of develop- interim remedial action. 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, collection and analysis as well as follow-up to nonconforming products and services, cus- evaluate the effectiveness of the actions taken.

Active monitoring programs may be set. The organization collects data to monitor its performance, including the following: Blood and blood component use. All confirmed transfusion reactions.

The organization compiles and analyzes data. The organization improves performance on an ongoing basis. These pro- tion is impractical, impossible, or outside the grams should be representative of the facility boundaries of the organization. Use of the re- processes and consistent with organizational petitive why prevents the mistake of inter- goals, and they should reflect customer needs.

The cause- annually in which data from all these sources are aggregated and analyzed can be valuable and-effect diagram, also known as the Ishika- to identify issues for performance improve- wa or fish-bone diagram, uses a specialized ment. An example of a lyzed to determine their scope, potential ef- cause-and-effect diagram is shown in Fig Such an analysis is important to process as well as to give a pictorial represen- avoid tampering with processes that are mere- tation of the ideas that are generated and their ly showing normal variations or problems with interactions.

When using the cause-and-effect little effect. The more complex the latent failures. Active failures are those that problem and the more involved the process, have an immediate adverse effect. Latent fail- the greater the need to enlist a team and to for- ures are more global actions and decisions malize the analysis.

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, by the presence of localized factors.

The key to use of the repetitive why, and the cause-and- successfully determining root causes is to effect diagram. Also new to this edition is online posting of the methods and appendices. More and more readers are becoming comfortable consulting digital resources; accordingly, the content methods, appendices of the USB flash card that was part of the printed edition is now online. An access code is printed in the book for easy, repeated reference and customization. Edited by: Claudia S.

Katz, MD. View Table of Contents pdf. View Preface pdf. View Sample Pages pdf. Privacy Policy Terms of Use. All Rights Reserved. Back to AABB. All Products. My Account Login. It is considered a comprehensive text that is sought after as a valuable resource assisting both seasoned professionals and newcomers in finding critical information quickly. With updated methods, illustrations, charts and more, each of the 32 chapters have been revised to reflect the latest research in the field.

What s New in this Edition: Key points summarizing each chapter. Expanded section on principles of immunology. Completely rewritten chapter on infectious diseases. Mail will not be published.

 
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Sorry, this item can only be purchased by current members. Additionally, this edition captures the late-breaking changes in donor deferrals made by the FDA just before publication. Other updates to the manual include:. Also new to this edition is online posting of the methods and appendices. More and more readers downloas becoming comfortable consulting digital resources; accordingly, the content methods, appendices of the USB flash card that was part of the printed edition is now online.

An access code is printed in the book for easy, repeated reference and customization. Edited by: Claudia S. Katz, MD. View Table of Contents pdf. Dowlnoad Preface pdf. View Sample Pages pdf.

Privacy Policy Terms of Use. All Rights Reserved. Back to AABB. All Products. My Account Login. Aabb technical manual free download Marketplace Product Details. Back to Technical Manual, 20th edition – Print. Technical Manual, 20th edition – Print Product Code: Technical Manual, 20th edition – Print. Write a Review. Back to Aabb technical manual free download Details. Please login to add items. Log In. Would /3891.txt like to Continue Shopping.

Want to save more? Log жмите to see if you qualify for a lower rate. Other updates to the manual include: Expanded PBM chapter. Critical update to discussion of massive transfusion. Emphasis on blood group antigen nomenclature. Added depth to relevant transfusion-transmitted diseases. Enhanced discussion of molecular testing. Transfusion Medicine Aabb technical manual free download Methods in Im Transfusion Therapy Antibody Identificat Technical Manual, Our Social Media.

 
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