Professional Documents
Culture Documents
Quality Systems
Q
UALITY, IN ALL ASPECTS of care Amendments to the 1967 Clinical Laboratory
and services, is the primary goal of Improvement Act, also known as “CLIA ’88,”
blood centers and transfusion ser- requires laboratories to establish and follow a
2
vices. A quality system is the organi- quality assurance program. In addition to the
zational structure, responsibilities, policies, blood product requirements in 21 CFR 606,
processes, procedures, and resources estab- the requirements in 21 CFR 211.22 describe
lished by executive management to achieve an independent quality control or quality as-
and ensure quality.1(p97) Many discrete activi- surance unit that has responsibility for the
ties, such as competence assessment of per- overall quality of the finished product and au-
sonnel, participation in laboratory proficiency thority to control the processes that may affect
testing programs, quality control (QC) of re- this product4 (see frequently used Code of Fed-
agents, procedures for equipment maintenance, eral Regulations quality-related citations in
and documentation of blood product deviation Appendix 1-1). As accrediting organizations,
investigations, are standard practice. Thus, for the American Association of Blood Banks
many organizations the foundation for a quality (AABB),1 the Joint Commission on Accredita-
system has been in place for some time. tion of Healthcare Organizations (JCAHO),6
The Centers for Medicare and Medicaid and the College of American Pathologists
7
Services (CMS)2 [formerly the Health Care Fi- (CAP) have also established requirements
nancing Administration (HCFA)] and the Food that address quality issues. The National Com-
and Drug Administration (FDA)3-5 have regu- mittee for Clinical Laboratory Standards
latory requirements for quality assurance. The (NCCLS) has developed a guideline on a qual-
1988 Clinical Laboratory Improvement ity system for the clinical laboratory.8
1
Copyright © 2002 by the AABB. All rights reserved.
2 AABB Technical Manual
A quality system includes QC, quality as- structure in any format that suits its opera-
surance (QA), and quality improvement, but is tions. Organizational trees or charts that show
broader in scope than these activities alone. the relationships, including operational indi-
The broader-based systems approach ensures viduals responsible for quality functions, are
application of quality principles throughout helpful.
the organization. Use of such an approach is The facility must define executive manage-
changing the focus of quality issues from de- ment and its responsibilities and authority.
tection to prevention. These include: facility operations, establish-
Business and industry have recognized the ment of and changes to the quality system,
benefit of a quality system approach for many compliance with regulatory and accreditation
years. They use the standards of the Interna- requirements, and assessment of the effective-
tional Organization for Standardization (ISO ness of the quality system. Such assessment
standards) to describe the elements of a qual- must be conducted through scheduled reviews.
ity system.9 The AABB Quality System Essen- The quality system must address all mat-
tials (QSEs)10 define the minimum aspects that ters related to compliance with federal, state,
must be addressed in a blood bank or transfu- and local regulations and accreditation stan-
sion service quality system. The AABB QSEs dards applicable to the organization. Manage-
were developed to be compatible with ISO ment must demonstrate active support of the
9000 standards and the FDA Guidelines for goals, objectives, and policies of the quality
Quality Assurance in Blood Establishments.5 function. There should be active participation
Implementation of the AABB QSEs is a good by management in the review and approval of
starting point for any facility interested in ac- quality and technical policies, processes, and
quiring ISO registration. Table 1-1 shows a procedures. The facility’s mission or vision
comparison of the AABB QSEs and ISO statement must show support of its quality
9000:2000 requirements. functions.
The remainder of this chapter discusses the A designated person who reports to man-
10 AABB QSEs and provides important infor- agement should oversee the quality functions.
mation a facility should consider when devel- This person has the responsibility to coordi-
oping its quality system. nate, monitor, and facilitate quality system ac-
tivities,5 but need not perform all of the quality
functions personally. Ideally, this person
should be independent of the operational
functions of the donor center or transfusion
service. However, in small facilities, this may
Organization not always be possible. The quality oversight
The first QSE relates to facility management. function has the authority to recommend
The facility must be organized in a manner and/or initiate corrective action when appro-
that promotes the implementation of an effec- priate.5 Depending on the size and scope of
tive quality system. The structure of the orga- the organization, the designated oversight per-
nization must be defined and documented son may work within a department (eg, trans-
and the responsibilities for the provision of fusion service), may have responsibilities cov-
blood, components, products, and services ering several areas (eg, laboratory-wide), may
clearly identified. The relationship of the posi- have a staff of workers (eg, quality unit), or
tion(s) responsible for key quality functions to may be part of an organization-wide unit (eg,
the rest of the organization must also be hospital quality management). Individuals act-
clearly defined. Each facility can define its ing in this oversight capacity, hereinafter re-
Table 1-1. Comparison of the AABB Quality System Essentials and the ISO
9000 Categories*
AABB Quality System Essentials ISO 9001:2000
tence evaluations of all staff whose activities ployee training and competence is re-
1(p76)
affect the quality of blood, components, tis- quired.
sues, or services.2,6 Depending upon the nature The quality oversight personnel should as-
of the job duties, such assessments should in- sist in the development, review, and approval
clude, but are not limited to: written evalua- of training programs, including the criteria for
tions; direct observation of activities; review of retraining.5 Quality oversight personnel also
work records or reports, computer records, monitor the effectiveness of the training pro-
and/or QC/QA records; testing of unknown gram and competence evaluations, review
samples; and evaluation of the employee’s proficiency testing results, and make recom-
5
problem-solving skills. mendations for changes as needed.
A formal competency plan that includes a
schedule of assessments, defined minimum ac-
ceptable performance, and remedial measures
is one way to ensure appropriate and consis- Equipment
tent competence assessments. Assessments
need not be targeted at each individual test or Equipment, instruments, measuring devices,
procedure performed by the employee; in- and computer systems (hardware and soft-
stead, they can be grouped together to assess ware), hereinafter referred to as equipment,
like techniques or methods and the specific are considered critical when used in the provi-
tests or procedures rotated. During routine re- sion of blood, components, tissues, and ser-
cord reviews, an exception log may be created vices.1(p4) This QSE addresses qualification,
to serve as a reference of employee compe- calibration, maintenance, and monitoring,
tence, rather than reviewing records for each which, when applicable, must be performed
specific employee. Written tests can be used for all critical equipment. Such activities help
effectively to evaluate problem-solving skills to ensure that equipment performs according
and to rapidly cover many topics by asking to the specifications (ie, requirements) defined
one or more questions for each area to be as- by the facility. Schedules for equipment moni-
sessed. For those personnel who participate, toring, calibration, and preventive mainte-
proficiency testing can be used to fulfill some nance provide a framework to conduct and
of the competence assessment requirements. review these activities. The diversity and com-
Assessments for testing personnel must be plexity of blood bank equipment require
compatible with “CLIA ’88,” which requires well-developed plans and procedures for qual-
that employees who perform testing be as- ification, implementation, and monitoring to
sessed 6 months after hire and annually there- ensure optimal and consistent performance.
after [42 CFR Part 493.1451(b)(9)]. For new equipment, policies and proce-
Prior to the introduction of a new test or dures should include a requirement to define
service, personnel must be trained to perform criteria for selection and requirements for in-
their newly assigned duties and deemed com- stallation, calibration, and qualification. After
petent. Annual reassessment of competence is installation, there must be documentation of
required thereafter.2 Although not required, any problems and the follow-up actions taken.
assessment of competence 6 months after the Recalibration and requalification may be nec-
introduction of these new duties may be pru- essary if repairs are made that affect the criti-
dent as well, particularly if the duties are com- cal operating functions of the equipment.
plex. Such early reassessment may prevent the Recalibration and requalification should also
inadvertent introduction of variation into the be considered when existing equipment is re-
process. Documentation of all aspects of em- located.
The facility must develop a mechanism to quirements.1(p7) The facility must have policies,
uniquely identify and track all critical equip- processes, and procedures to evaluate the sup-
ment. The version of software used in critical pliers’ abilities to meet these requirements.
equipment should also be tracked. The unique The three elements in this QSE focus on: sup-
identifier may be facility-specific or the manu- plier qualifications; agreements; and receipt,
facturer’s serial number can be used. If the fa- inspection, and testing of incoming supplies.
cility is part of a larger organizational struc- The quality oversight personnel play a major
ture, the mechanism may be part of a role in approving supplier requirements and
laboratory-wide or organization-wide identifi- the criteria for accepting supplies or services
cation system. A listing of all critical equip- and providing input into supplier contracts.
ment and its unique identifier serves as a tool
to assist in the control function of scheduling Supplier Qualification
and performing monitoring, calibrations, and The facility’s critical supplies and services and
preventive maintenance. Records of such ac- the functional requirements and expectations
tivities, as well as repairs, must be kept and pe- for each must be defined. The facility must
riodically reviewed. The equipment listing can also clearly define requirements or expecta-
be used to ensure that all appropriate records tions for the suppliers of these critical materi-
have been created and reviewed. Evaluation als and services and share these requirements
of equipment records and trends will assist the with staff and the supplier. Supplier names for
facility in assessing the functionality of the each critical supply or service should be docu-
equipment, allow for better control in manag- mented, as well as acceptable alternates for
ing defective equipment, and assist in identify- contingencies. Based on these defined expec-
ing equipment that may need replacement. tations, the facility can document a supplier’s
ability or inability to meet them. The greater
the potential risk to patients or to the safety of
Supplier and Customer the blood supply, the more emphasis should
be placed on evaluation and qualification of
Issues supplies, services, and their providers.
Each facility should identify which supplies Examples of factors that could be consid-
and services it considers critical and define re- ered to qualify suppliers are:
quirements for these critical supplies and ser- ■ Licensure, certification, or accreditation
1(p7)
vices, as well as requirements for the suppliers. (as required by AABB Standards ).
Examples of critical supplies are blood compo- ■ Supply or product requirements.
nents, blood bags, test kits, and reagents. Ex- ■ Review of supplier-relevant quality doc-
amples of critical services are infectious uments.
disease testing, blood component irradiation, ■ Results of audits or inspections.
transportation, and equipment calibration and ■ Review of quality summary reports.
preventive maintenance. Suppliers can be in- ■ Review of customer complaints.
ternal (eg, other departments within the same ■ Review of past experience with supplier.
organization) or external. Supplies and ser- ■ Cost of materials or services.
vices used in the collection, testing, processing, ■ Delivery arrangements.
preservation, storage, distribution, transport, ■ Financial security, market position, and
and administration of blood, components, and customer satisfaction.
tissue that have the potential to affect quality ■ Support after the sale.
should be qualified before use and obtained A list of approved suppliers should be
from suppliers who can meet the facility’s re- maintained. Critical supplies and services
should be purchased only from those suppliers gally responsible for the work performed by
who have been qualified. Once a supplier has the contractor.
been qualified, there should be periodic evalu- The blood bank or transfusion service
ation of performance to ensure continued abil- should participate in the evaluation and selec-
ity to meet requirements. Documented fail- tion of suppliers prior to agreement accep-
ures of supplies or suppliers to meet defined tance. They should be able to review contracts
requirements should result in immediate ac- and agreements and make suggestions to en-
tion by the facility. These actions should in- sure that all important aspects for their critical
clude notification of the supplier, quality over- materials and services are clearly covered. Ex-
sight personnel, and management with amples of issues that could be addressed in an
contracting authority, if applicable. Quaran- agreement or contract include: a definition of
tine or replacement of supplies until all quality the responsible party during shipment of the
issues are resolved may also be required. product; the responsibility of the supplier to
Tracking the supplier’s ability to meet ex- promptly notify the facility when changes that
pectations gives the facility valuable informa- could affect the safety of blood, components,
tion about the stability of the supplier and the or patients have been made to the materials or
supplier’s commitment to quality. services; and the responsibility of the supplier
Careful review of the documentation will to notify the facility when information that a
alert management to trends in the supplier’s product may not be considered safe is discov-
qualifications and should result in early detec- ered, such as during look-back procedures.
tion of supplier problems. Continued surveillance of the materials and
services, as discussed above, is critical.
to prevent inadvertent use until further action components, tissues, and services and for
is determined. Corrective actions could result making changes to existing ones. Medical and
in the return or destruction of these materials. technical policies, processes, and procedures
Receipt and inspection records provide the fa- must be reviewed by the quality oversight per-
cility with evidence of ongoing supplier quali- sonnel, technical management (medical direc-
fication regarding shipping and packaging of tor, or physician designee, of transfusion
critical materials. service or donor center), and executive man-
Facility policies and procedures should de- agement, if applicable, prior to implementa-
fine which materials and products require test- tion. Changes made to policies, processes, or
ing before their addition to the facility’s usable procedures must be documented, validated,
inventory. Generally, reagents used in critical reviewed, and approved. Additional informa-
procedures such as ABO, Rh, and infectious tion on policies, processes, and procedures can
disease marker testing must be checked be- be found in the Documents and Records
fore use in patient or donor testing. These tests section.
will give a measure of assurance that shipping Once process control has been imple-
and storage of the reagents did not adversely mented, the facility must have a mechanism to
affect their potency. ensure that processes and procedures are per-
formed as defined and that critical equipment
and supplies are used in conformance with
manufacturers’ written instructions and facil-
Process Control ity requirements. Table 1-2 lists elements that
Process control is the most encompassing of constitute sound process control.
the QSEs. Full compliance with this QSE al-
lows the facility to be in control of its operating Validation
processes. Policies, processes, and procedures Validation is the prospective development of
must exist for all critical functions in the facil- process requirements and documented verifi-
ity and be carried out under controlled condi- cation that they have been consistently met.
tions. Each facility must have a defined One of the most important aspects of valida-
mechanism for identifying, planning, and im- tion is the validation plan. The plan may out-
plementing new policies, processes, and proce- line prospective validation (most often used
dures that affect the quality of blood, for new or revised processes) or retrospective
validation (used for processes implemented be appended to the approved validation plan
before the validation requirement). Concur- or recorded in a separate document. This doc-
rent validation (used when required data can- umentation typically contains the following el-
not be obtained without performance of a ements:
“live” process) may also be performed if pro- ■ Results
spective validation is not an option. If concur- ■ Conclusions and limitations
rent validation is used, data are reviewed at ■ Approval signatures
predefined periodic intervals before final ap- ■ Supporting documentation
proval for full implementation occurs. ■ Implementation time line
Should the validation process not result in
Validation Plan the expected outcome, those data and the cor-
It is suggested that an organization develop a rective actions must be documented as well.
template for a validation plan. Development of The responsible quality oversight personnel
a validation plan is best accomplished after ob- should have final review and approval of the
taining an adequate understanding of the sys- validation plan, results, and corrective actions,
tem, which is the framework within which the and determine whether new or modified pro-
process will occur. Although no single format cesses and equipment may be implemented,
for a validation plan is required by regulation, or implemented with specified limitations.
the following elements are common to most: When there are significant changes to a pro-
■ System description cess, such as a change of equipment, revised
■ Purpose/objectives SOP, or change of supplies or reagents, the
■ Risk assessment need for revalidation must be evaluated.
■ Responsibilities
■ Validation procedures Computer System Validation
■ Acceptance criteria The FDA recently issued guidance for com-
■ Approval signatures puter software validation.12 This guideline de-
■ Supporting documentation fined a computer system to include: “hard-
Validation of new processes that include ware, software, peripheral devices, personnel,
equipment should include installation qualifi- and documentation.” Thus, validation plans
cation, operational qualification, and product for computer systems in blood banking must
qualification.11 include all of the areas referenced above.
■ Installation qualification focuses on the Computer systems may be custom-developed,
capability of the equipment to operate vendor-developed, or a hybrid. The develop-
within the established limits and specifi- ment of a validation plan specific to computers
cations supplied by the manufacturer. depends on the type of system to be used.
■ Operational qualification demonstrates Testing performed by the vendor or supplier
that the process will produce the desired of computer software is not a substitute for
result or defines the process limits. computer validation by the user. It should be
■ Product qualification provides assurance remembered that a computer is typically used
that the process results in acceptable within a process. Depending upon the nature
measurable or quantifiable specifica- of the computer functionality, changes to the
tions attributed to the product. computer system may result in changes to
Once the validation plan is approved, the how a process is performed. If this occurs, pro-
staff who are experienced in the process per- cess validation, conducted by personnel who
form the approved validation plan activities. will perform the process and use the computer
Results and conclusions of these activities may system, must also be performed. As with pro-
cess validation, quality oversight personnel mined by each facility in accordance with the
should review and approve validation plans, appropriate CLIA, FDA, AABB, state, and
results, and corrective actions, and determine manufacturer’s requirements. QC results must
whether implementation may proceed with or be documented concurrently with perfor-
without limitations. mance.3,4 Records of QC testing must include
identification of personnel, identification of re-
Proficiency Testing agent (including lot number, expiration dates,
etc), identification of equipment, testing date
Proficiency testing (PT) is one of several and time (when applicable), results, interpreta-
means for determining that test methods (in- tion, and reviews. Policies should be estab-
cluding supplies and equipment used in those lished for repeat QC testing when results fall
test methods) are working as expected and outside acceptable parameters. These should
that test outcomes are meeting predetermined include documentation of results for all initial
standards. Controlling the PT process, by hav- and repeat testing, as well as evaluation for
ing clearly defined SOPs, ensures that all staff trends. Corrective action for unacceptable QC
who perform both routine and backup test results should also be carefully documented
methods have a consistent process to follow. and reviewed. See Appendix 7 and Methods
SOPs should cover how to handle PT samples Section 8 for suggested QC testing frequencies
from receipt through testing and how to report and specific QC procedures.
the results. The review process for the sum-
mary evaluation should include how to per-
form and document corrective action when
applicable. Quality oversight personnel review Documents and Records
and monitor PT results, periodically evaluate
the proficiency program, and approve correc- The Documents and Records QSE sets the
tive action plans when PT results are unac- groundwork for many of the processes in the
ceptable. “CLIA ’88” requires in 42 CFR Process Control QSE. To comply with this es-
493.1213 that test performance be verified sential, facilities must have a process to ensure
for each analyte and defines consequences for that documents, which provide guidance for
failed proficiency testing.2 Blood centers and or evidence of performance of the job, are
transfusion services are required to participate controlled. This means that policies, process
in a CMS-approved proficiency testing pro- descriptions, procedures, and forms are identi-
gram.1(p9) fied, approved, implemented, and re-
tained.1(p68) Forms must be designed to effec-
tively capture outcomes and support process
Quality Control
traceability. Records (completed forms) must
QC is the testing routinely performed to en- be created concurrently with the performance
sure the proper functioning of materials, of each significant step and clearly indicate the
equipment, and methods. QC of reagents, identity of individuals who performed each
equipment, and methods used in collecting, step and when it occurred.13 When critical re-
testing, modifying, or otherwise affecting cords are generated, it is necessary to ensure
blood or component quality is essential. QC that they are reviewed by a second person for
performance characteristics and acceptable completeness and accuracy and are approved.
ranges should be readily available so that un- Records must be stored and archived in a de-
acceptable variations or results can be fined manner that meets the facility’s needs
promptly detected and appropriately handled. and is consistent with local, state, and federal
The frequency for QC testing should be deter- regulations. They must be maintained in us-
able condition, retained for specified periods, reasonable, provide staff with useable instruc-
a n d o rg a n i z e d f o r t ra c e a b i l i t y a n d tions and forms, and satisfy regulations.
retrievability. The facility’s documents and re- Documents should provide staff and others
cords management system may be manual with a clear idea of how objectives are accom-
and/or electronic. plished. Although there are many ways to de-
velop and maintain documents, the approach
Documents embraced by the AABB and the NCCLS14 is
The goal of the documents management sys- based on the ISO 9001 model.15 The NCCLS
tem is to achieve control of the facility’ docu- offers detailed instructions on how to write
ments. This requires a well-defined structure documents.14
that should be capable of linking policies, pro-
cess descriptions, procedures, forms, and re- Level I Documents
cords together in an organized and workable Document control based on the ISO 9001
system. model is best described as the pyramid shown
Document development within an organi- in Fig 1-1. At the top of the pyramid is Level I,
zation should be based on methods that are which consists of the facility’s quality policies
compiled into a quality manual or quality pro- tasks and are step-by-step directions on how to
gram. These documents are time-independent perform those tasks. The SOPs should be de-
and describe the facility’s overarching quality tailed enough to provide the information
policy, or mission statement, and the facility’s needed to perform the task, but not so detailed
policies regarding the 10 QSEs. The docu- as to make it difficult to find the directions for
ments also contain the facility’s policies that the task. Procedures should be in a standard-
conform to federal, state, and local regula- ized format to assist staff and management in
tions. Individuals from top-level management their control and implementation.1(p68) Proce-
and the quality oversight function usually dures must be written for QA, QC, clerical,
write these documents. These policies may be and operational functions. Procedures may
briefly stated in a single document and refer- also be incorporated by reference, such as
ence other, more detailed documents for addi- those from a manufacturer’s manual. Relevant
tional information. Alternatively, each policy procedures must be available to staff at each
can be addressed in a separate document con- site where the corresponding job tasks are per-
taining more detailed information, such as a formed.
1(p68)
The Process for Document Development ment distribution and superceded documents;
and Management and the process for archiving, protecting, and
retrieving obsolete documents. There must be
Each facility must have a process that defines
a description of the process for changing poli-
its approach for developing and maintaining
documents. This Level II process (sometimes cies and procedures and how to document
called the “SOP for SOPs”) should define: the and track the changes, as well as to review and
chosen structure for SOPs; the process for re- validate those changes when needed. The re-
view and approval of new or revised docu- view process should define who performs the
ments by quality oversight personnel and review, how the review is documented, and
management; annual review; control of docu- how often the review is performed.
Because supplies, reagents, and critical Requirements for Level IV document con-
equipment must be used in a manner consis- trol are similar to those for Level II and III
tent with the manufacturer’s directions (21 documents. Although Level IV documents
CFR 606.65), incorporating the manufac- may be blank forms, they must be reviewed
turer’s directions into the SOPs is advisable. In- prior to implementation to determine if they
corporation of these directions requires that the will capture the needed information and com-
facility have a mechanism to detect changes to ply with regulations. There must be a mecha-
a manufacturer’s package insert or user man- nism to control these forms, ie, validate their
ual so that corresponding changes to SOPs can accuracy and completeness, track their distri-
be made. If incorporated by reference, then bution, ensure their removal when super-
the facility must include these external docu- ceded, and control changes made to them.
ments in the document management process Included in the document management
(eg, review and approval prior to use, annual process is a master copy of each policy, pro-
review, and archiving of obsolete documents). cess description, and procedure; an index of
A facility using reagents, supplies, or critical all current policies, process descriptions, and
equipment in a manner that is different from procedures; and an archive of obsolete docu-
the manufacturer’s directions must have vali- ments.5 The number of policies, process de-
dated such use and may be required to re- scriptions, and procedures in circulation
quest a variance from the FDA under 21 CFR (working copies) should be controlled to en-
640.120. If a facility believes that changes to sure that none are overlooked when changes
the manufacturer’s directions would be appro- are implemented. To facilitate their replace-
priate, they should encourage the manufac- ment, it maybe also be helpful to include the
turer to make such changes in the labeling (ie, location of copies as well. It is essential to in-
package insert or user manual). clude the date of writing a policy, process, or
Many regulatory and accreditation bodies procedure and the dates of implementation
suggest that SOPs include examples of the and revision. Another helpful practice is to
forms used to record data. Inclusion of current keep a log of changes to documents and the
blood and component labels in SOP manuals rationale for the change.
is also desirable. Procedures for the review,
maintenance, and disposition of records must Document Review and Revision
be available. Written and/or pictorial descrip- After publication of each new edition of volun-
tions of how to read, score, and record all test tary standards, such as the AABB Standards
results and interpretations, when applicable, for Blood Banks and Transfusion Services,1 or
are helpful. Directions for managing possible upon receipt of any change in federal, state, or
problems should be included, as well as the local requirements, relevant documents
limits placed on an individual’s independent should be examined for conformance with the
judgment and criteria for consulting a supervi- new requirements. Review and approval of
sor. new or changed documents must occur before
Before implementation, procedures should their use.1(p68)
be validated, ie, tested for accuracy and com- When new or revised policies, process de-
pleteness, and evaluated for their confor- scriptions, procedures, or forms are added to
mance to regulations and for their potential or replaced in the facility manual, the docu-
impact on other systems. Procedures are to be ments must be marked with the effective date.
reviewed and approved by quality oversight One copy of retired documents must be re-
personnel and management before their im- tained as defined by existing and applicable
plementation. standards and regulations. Regulatory agen-
cies require appropriate demonstrable control fined by job responsibility and administered
of SOPs (no unauthorized, antiquated, or in- by the use of security codes and passwords.
consistent SOPs in use); however, those in If records are electronically maintained, ad-
charge are free to delegate such responsibili- equate backup must exist in case of electronic
ties. 21 CFR 211.100 requires SOPs to be system failure. Records must also be easily re-
drafted, reviewed, and approved by the appro- trieved for reference or review. It should be
priate organizational units and reviewed and noted that “easily retrieved” has various defi-
approved by the quality control unit (ie, qual- nitions depending on the organization re-
ity oversight personnel). questing retrieval.
Each facility should have a policy for alter-
ing or correcting records. A common practice
Records in use is to indicate the date, the change, the
When forms are used for capturing data or re- identity of the person making the change, and
cording steps or test results, the forms become evidence of review by a responsible person.
records. Each facility must define the content The original recording must not be obliterated
for each form and how to complete it. The fa- in written records; it may be circled or crossed
cility must also define the record review pro- out with a single line, but it should remain legi-
cess and time frames for the review. The ble. Computer records should permit tracking
policies, processes, and procedures must de- of both original and corrected data to include
scribe how reports and records are archived the date and the user identification of the per-
and their retention period. (See Appendices son making the change. There must be a pro-
1-2 to 1-7 for details on record-keeping re- cess for controlling changes.1(p70) A method for
quirements.) Obsolete computer software, referencing changes to records, linked to the
necessary to reconstruct or trace records, must original records, and a system for reviewing
also be archived appropriately. When copies changes for completeness and accuracy are es-
of records are retained, there must be a pro- sential. Audit trails for changed data in comput-
cess to verify that the copy contains complete, erized systems are required by the FDA.17 The
legible, and accessible content of the original information must be maintained electronically.
record before its destruction. The following are issues that might be con-
Electronic media such as magnetic tapes, sidered when planning record storage:
optical disks, or on-line computer data storage ■ Storage of records in a manner that pro-
are widely used for archiving documents. Re- tects them from damage and from acci-
cords kept in this manner must meet FDA re- dental or unauthorized destruction or
quirements for electronic record-keeping.17 modification.
The potential also exists to use microfiche and ■ Degree of accessibility of records in pro-
optical character-reading devices to archive portion to frequency of their use.
written records. The medium selected should ■ Method and location of record storage
be appropriate for the retention requirements. related to the volume of records and the
Confidentiality of blood bank records, as all amount of available storage space.
medical information, must be addressed. Or- ■ Availability of properly functioning
ganizations should establish policies and pro- equipment/hardware/software to view
cedures to maintain the security and confiden- archived records.
tiality of records. An appropriately maintained ■ Documentation that microfiched re-
computer access security system that will re- cords legitimately replace original docu-
strict unauthorized use must be described. ments that may be stored elsewhere or
This system may include levels of security de- destroyed.
19
Table 1-4. Components of an Internal Event Report
WHO ■ Identity of reporting individual(s)
■ Identity of individuals involved (by name or job title) in committing,
compounding, discovering, investigating, and initiating any immediate
action
■ Patient or donor identification
■ Reviewer(s) of report
WHAT ■ Brief description of the event
■ Effects on and outcome to patient, donor, or blood component
■ Name of component and unit identification number
■ Manufacturer, lot number, and expiration of applicable reagents and
supplies
■ Immediate action taken
WHEN ■ Date of report
■ Date and time the event occurred
■ Date and time of discovery
■ Collection and shipping dates of blood component(s)
WHERE ■ Physical location of event
■ Where in the process it was detected
■ Where in the process it was initiated
WHY/HOW ■ Explanation of how event occurred
■ Contributing factors
■ Root cause(s)
FOLLOW-UP ■ External reports or notifications (eg, FDA*, manufacturer, or patient’s
physician)
■ Corrective actions
■ Implementation dates
■ Effectiveness of actions taken
18
*All blood establishments (including licensed, registered but unlicensed, and unregistered transfusion services) are
required to notify the FDA if the following occur: deviations from cGMP regulations, applicable standards, or
established specifications that may affect the safety, purity, or potency of biological products or otherwise cause the
biological products to be in violation of the FD & C Act or the PHS Act (21 CFR 600.14). The FDA has identified the
following examples as reportable events if components or products are released for distribution:
– Arm preparation not performed or done incorrectly
– Units from donors who are (or should have been) either temporarily or permanently deferred due to their medical
history or a history of repeatedly reactive viral marker tests
– Shipment of a unit with repeatedly reactive viral markers
– ABO/Rh or infectious disease testing not done per manufacturer’s package insert
– Units from donors for whom test results were improperly interpreted due to testing errors related to improper use
of equipment
– Units released prior to completion of all tests (except as emergency release)
– Sample used for compatibility testing that contains the incorrect identification
– Testing error that results in the release of an incorrect unit
– Incorrectly labeled blood components (eg, ABO, expiration date)
– Incorrect crossmatch label or tag
– Storage of biological products at the incorrect temperature
– Microbial contamination of blood components when the contamination is attributed to an error in manufacturing
Table 1-4 outlines suggested components of tion relevant to these events, to the FDA using
an internal event report. Form FDA-3486 when the event:
Included in the process for reporting must ■ Is associated with manufacturing (ie,
be events involving blood components and testing, processing, packing, labeling,
critical materials that fail to meet established storing, holding, or distributing).
requirements at the time of incoming inspec- ■ Represents a deviation from current
tion, while held in inventory, or at the time of good manufacturing practice, applicable
distribution or issue. In a transfusion service, regulations or standards, established
reporting should include issue of an incorrect specifications, or is unexpected or un-
or unsuitable blood component, sample col- foreseen.
lection or testing failures that lead to such re- ■ May affect the safety, purity, or potency
lease, as well as reports of patients experienc- of the product.
ing adverse effects as a result of transfusion. ■ Occurs while the facility had control of
Events must also be reported if computer sys- or was responsible for the product.
tems are not functioning properly. ■ Involves product that leaves the control
Suspected cases of transfusion-associated of the facility (ie, distributed).18
diseases must be evaluated; confirmed cases The JCAHO requires the reporting of senti-
must be reported to the collecting facility. nel events, which for transfusion services
FDA requirements for look-back regarding means reporting hemolytic transfusion reac-
human immunodeficiency virus (HIV) have tions involving administration of blood or
been defined in 21 CFR Parts 610.46 and components having major blood group incom-
610.47 for collection and transfusion facilities. patibilities.6 There must also be a mechanism
The CMS has defined identical look-back re- to report medical device adverse events to the
quirements for transfusion services in 42 CFR FDA (21 CFR 803). Each facility should have
482.27(c). Additional FDA memoranda ad- processes and procedures in place that ad-
dress recommendations for other transfu- dress how to report each applicable type of
sion-transmitted diseases and should be refer- event.
enced when developing look-back procedures. Each facility should track all events re-
Fatalities related to blood collection or ported and look for trends. This usually re-
transfusion must be reported promptly to the quires the development of a mechanism for
FDA Center for Biologics Evaluation and Re- numbering the reports and classifying the
search (CBER). A report must be made within events. Classification schemes typically in-
24 hours by telephone (301-827-6220), volve one or more of the following categories:
e-mail (fatality2@cber.fda.gov), or fax the nature of the event, the process (or proce-
(301-827-6748). A written report must be dure) in which the event occurred, event se-
submitted within 7 days [21 CFR 606.170(b)] verity, and causes. If several events within a
to CBER Director, Office of Compliance and relatively short time period involve a particu-
Biologics Quality, Attn: Fatality Program Man- lar process or procedure, that process or pro-
ager (H FM-650), 1401 Rockville Pike, cedure should be further investigated. The
Rockville, MD 20852-1448. The report most useful schemes involve use of multiple
should include a description of any new proce- categories for each event, which allow data to
dures implemented to avoid recurrence. be sorted in a variety of ways so that patterns,
All licensed facilities, registered facilities, previously not obvious, can emerge (see exam-
and transfusion services must promptly report ple in Table 1-5). Such sorting can result in
biological product deviations (previously identification of situations that require closer
known as errors and accidents), and informa- monitoring or of problems needing corrective
that opportunities for improvement can be side 1 standard deviation (SD), 2 SD, and 3
recognized.1(p85),20 Early detection of trends SD indicate a process that is out of control; the
makes it possible to develop preventive ac- root cause should be determined and correc-
tions before patient safety or blood products tive action should be initiated if indicated.
are adversely affected. Evaluation summaries
provide information useful in correcting indi-
vidual or group performance problems and
Blood Utilization Assessment
ensuring adequacy of test methods and equip-
ment. In addition to review of assessment re- The activities of blood usage review commit-
sults, executive management must review any tees in the transfusion setting are an example
associated corrective or preventive action. of internal assessment. A transfusion audit is a
defined review of policies and practices to en-
sure safe and appropriate transfusions and is
Quality Indicators based on measurable, predetermined perfor-
mance criteria. Guidelines are available from
Quality indicators are specific performance
the AABB for both adult and pediatric utiliza-
measurements designed to monitor one or
tion review.21-23
more processes during a defined time and are
Peer review of transfusion practices, re-
useful for evaluating service demands, pro-
quired by the AABB, is also required by the
duction, adequacy of personnel, inventory
JCAHO6 for hospital accreditation, by the
control, and process stability. These indicators
CMS2 for hospitals to qualify for Medicare re-
can be process-based or outcome-based. Pro-
cess-based indicators measure the degree to imbursement, and by some states for Medicaid
which a process can be consistently per- reimbursement.
formed. An example of a process-based indi- Transfusion services should investigate an
cator is measurement of turnaround time from adequate sampling of cases (ie, 5% of the
blood product ordering until transfusion. Most number of cases occurring within a defined
frequently used are outcome-based indicators, time frame or 30 cases, whichever is larger).
which measure what does or does not happen The audit should assess the facility’s effective-
after a process is or is not performed. An ex- ness in:
ample of such an indicator is counting the ■ Monitoring blood ordering practices for
number of incorrect test result reports. For all categories of blood and products.
each indicator, thresholds are set that repre- ■ Monitoring wastage of blood compo-
sent warning limits and/or action limits. These nents.
thresholds can be determined from regulatory ■ Developing and approving policies and
or accreditation requirements, benchmarking, procedures for distribution, handling,
or internally derived from data. use, and administration of blood prod-
Tools frequently used for displaying quality ucts.
indicator data are run charts and control ■ Reviewing all confirmed transfusion re-
charts. In a run chart, time is plotted on the actions.
x-axis and values on the y-axis. In control ■ Ensuring that the institution’s transfu-
charts, the mean of the data and upper and sion service adequately meets patient’s
lower control limits, which have been calcu- needs.
lated from the data, are added to the chart. ■ Informing patients and physicians in a
Single points outside the upper and lower con- timely and confidential manner when
trol limits result from special causes. Statistical look-back is required for possible HCV
rules for interpreting consecutive points out- or HIV transmission.
Currently, JCAHO incorporates the above tion of evolving technologies and products
requirements into performance improvement such as solvent/detergent-treated plasma,
standards, which are listed in Table 1-6.6 growth factors, and cytokines. Appendix 1-8
One important aspect of transfusion safety lists blood utilization assessment examples.
is monitoring the blood administration pro-
cess, ie, following a unit of blood as it is issued External Assessments
for transfusion and observing the transfusion External assessments include inspections, sur-
procedure.22 Another aspect of transfusion veys, audits, etc, performed by those not affili-
safety is the review of transfusion reactions ated with the organization, such as the FDA,
and transfusion-transmitted diseases. The re- AABB, CAP, or JCAHO. Facilities must have
view committee may monitor policies and policies and procedures that ensure external
practices for notifying recipients of recalled assessments are obtained as required and de-
products (look-back notification) and donors fine how to manage such assessments. In the
of abnormal test results. Other assessments preparation phase of scheduled assessments,
important in transfusion practice include re- there is typically some data gathering and in-
view of policies for informed consent, indica- formation to submit to the organization per-
tion for transfusion, release of directed donor forming the assessment. Coordination of the
units, or outpatient and home transfusion. Ad- assessment, which includes arranging dates
ditional assessments should include, where ap- and notification of necessary personnel, needs
propriate: therapeutic apheresis, procurement to occur. During the assessment phase, it is im-
and storage of hematopoietic progenitor cells, portant to know how to greet the assessors or
perioperative autologous blood collection, inspectors and who is responsible for these in-
procurement and storage of tissue, and evalua- dividuals during the time they are in the facil-
ity. Clear descriptions of what information can tion can be thought of as a reactive approach to
be given to the external assessors or inspec- reported problems that includes a preventive
tors, and in what form, will help the facility component, whereas preventive action can be
through the assessment or inspection process. thought of as a proactive approach resulting
During the postassessment phase, issues iden- from analyzing information. In contrast, reme-
tified must be addressed and usually a written dial action is defined as the action taken to
response submitted. A clear delineation of the alleviate the symptoms of existing noncon-
responsibilities of all staff members in each formances or any other undesirable situa-
phase is essential. tion.25,26 Remedial action addresses only the
visible indicator of a problem, not the actual
cause (see comparisons in Table 1-7). Effec-
Process Improvement tive corrective action, and effective preventive
action as well, cannot be implemented until a
The importance of identifying, investigating,
process is evaluated in relationship to other
correcting, and preventing problems has been
processes and the underlying cause(s) deter-
clearly established in transfusion medicine.
mined. Pending such evaluation, it may be de-
The corrective and preventive action process
sirable to implement remedial action.
includes identification of problems and their
causes, and identification and evaluation of so-
lutions to prevent future problems. To be in
Identification of Problems and Their
compliance with this QSE, the facility must
Causes
have a defined process to identify the need for Sources of information for process improve-
corrective or preventive action. The process ment activities include the following: blood
must include a mechanism for data collection product and other deviations; nonconforming
and analysis, and follow-up to evaluate the ef- products and services; customer complaints;
fectiveness of the actions taken. Statistical QC records; proficiency testing; internal au-
tools and their applications may be found in dits; quality indicators; and external assess-
publications from the American Society for ments. Preparation of an annual facility
Quality, as well as specific AABB publica- quality report, in which data from all these
tions.25,26 sources are collated and analyzed, can be a
Corrective action is defined as the action valuable tool to identify issues for process im-
taken to eliminate the causes of an existing provement. Such a report is required of li-
nonconformance or other undesirable situa- censed manufacturing facilities by the FDA.
tion in order to prevent recurrence.1(p94) Pre- Selection of problem identification mecha-
ventive action is defined as the action taken to nisms is an important quality management de-
eliminate the causes of a potential noncon- cision. Mechanisms should be representative
formance or other undesirable situation in or- of the facility processes, consistent with orga-
der to prevent occurrence.1(p97) Corrective ac- nizational goals, and reflect customer needs.
27
Table 1-7. Comparison of Remedial, Corrective, and Preventive Action
Action Problem Approach Outcome
Other important decisions include whether to localized factors. The key to successfully de-
address the identified problems. This requires termining root cause is not to stop too soon or
careful consideration so that tampering with get caught in the trap of placing blame on an
processes that are just showing normal varia- individual.
tion does not occur. Most problems, particularly those that are
Identifying underlying causes for an unde- complex, have several root causes. A method
sirable condition or problem can be done by that can be of use when this occurs is the
an individual or group. The more complex the Pareto analysis. A chart of causes, laid out in
problem and the more involved the process, order of decreasing frequency, is prepared.
the greater the need to enlist a team of individ- Those that occur most frequently are consid-
uals and to formalize the analysis. The three ered the “vital few”; the rest are considered
most commonly used tools for identifying un- the “trivial many.” This method offers direc-
derlying causes in an objective manner are tion about where to dedicate resources for
process flowcharting, use of the “repetitive maximal impact.
why,” and the cause-and-effect diagram. A
process flowchart gives a detailed picture of Identification and Evaluation of Solutions
the multiple steps and the important decision Potential solutions to problems are identified
points within that process. By examining this during the creative phase of process improve-
picture, problem-prone areas may be identi- ment. Brainstorming and process flowcharting
fied. When the “repetitive why” is used, one can be particularly helpful in this phase. Possi-
works backward through the process and re- ble solutions should be evaluated relative to
peatedly asks the question “why?” until no organizational constraints, and narrowed
new information can be gleaned, the causal down to those most reasonable. Individuals
path cannot be followed because of missing in- who perform the process are usually the most
formation, or further investigation is impracti- knowledgeable about what will work. They
cal, impossible, or outside the boundaries of should be included when possible solutions
the organization. Use of the “repetitive why” are being considered. Individuals with knowl-
prevents the mistake of interpreting an effect edge of the interrelationships of processes and
as a cause. the more “global” view of the organization
The cause-and-effect diagram, also known should also be included. Solutions may fail if
as the Ishikawa or fish-bone diagram, employs representatives with these perspectives are not
a specialized form of brainstorming that involved.
breaks down problems into “bite-size” pieces. Potential solutions should be tested before
It is a method designed to focus ideas around full implementation, with a clear plan relative
the component parts of a process, as well as to methods, objectives, timelines, decision
give a pictorial representation of the ideas that points, and algorithms for all possible results
are generated and their interactions. When us- of the trial. Large-scale solutions can be tried
ing the cause-and-effect diagram, one looks at on a limited basis and expanded if successful;
equipment, materials, methods, environment, smaller scale solutions can be implemented
and human factors. Use of these tools identi- pending an effectiveness evaluation. Regard-
fies more than active failures, those in which less, data should be collected to evaluate the
there is an immediate adverse effect. It allows effectiveness of the proposed change. Data
identification of latent failures, those more can be collected by the methods used in ini-
global actions and decisions with potential for tially identifying problems or by methods spe-
damage that may lie dormant and become evi- cially designed for the trial. Once solutions
dent only when triggered by the presence of have been successfully tested, full implemen-
tation can occur. Following implementation, 3. Code of federal regulations. Title 21 CFR Parts
600-799. Washington, DC: US Government Print-
data to support the continuing effectiveness of ing Office, 2001 (revised annually).
the change should continue to be collected, on 4. Code of federal regulations. Title 21 CFR Parts
200-299. Washington, DC: US Government Print-
at least a periodic basis, to ensure that the pro- ing Office, 2001 (revised annually).
cess continues to stay in control. 5. Food and Drug Administration. Guideline for qual-
ity assurance in blood establishments. Docket
#91N-0450. (July 11, 1995). Rockville, MD:
CBER Office of Communication, Training, and
Manufacturers Assistance, 1995.
Facilities and Safety 6. Hospital accreditation standards. Oakbrook Ter-
race, IL: Joint Commission Resources, Inc., 2002.
Multiple federal, state, and local agencies have 7. College of American Pathologists Laboratory Ac-
regulations addressed in this QSE. To comply creditation Program checklists. Chicago, IL: Col-
lege of American Pathologists, 2001.
with this QSE, the facility must provide a safe 8. A quality system model for health care; NCCLS ap-
workplace with adequate environmental con- proved guideline (GP26-A). Wayne, PA: National
trols and emergency procedures for the safety Committee for Clinical Laboratory Standards,
1999.
of the employees, donors, patients, and all 9. ANSI/ISO/ASQ Q9000-2000 series – quality
other inhabitants or visitors.1(p87) Procedures management standards. Milwaukee, WI: ASQ
Quality Press, 2000.
must be in place that cover: 10. Quality program implementation. Association Bul-
■ General safety letin 97-4. Bethesda, MD: American Association
of Blood Banks, 1997.
■ Disaster preparedness 11. Food and Drug Administration. Guidance on gen-
■ Biologic safety (blood-borne pathogens) eral principles of process validation. (May 1, 1987).
Rockville, MD: CBER Office of Communication,
■ Chemical safety Training, and Manufacturers Assistance, 1987.
■ Radiation safety, if applicable 12. Food and Drug Administration. Guidance for In-
■ Discard of blood, components, and tis- dustry: General principles of software validation:
Final guidance for industry and FDA staff. (Janu-
sue ary 11, 2002). Rockville, MD: CBER Office of
Current good manufacturing practice regu- Communication, Training, and Manufacturers As-
sistance, 2002.
lations include requirements for: 13. Code of federal regulations. Title 21 CFR Part
■ Adequate space and ventilation 606.160(d). Washington, DC: US Government
Printing Office, 2001 (revised annually).
■ Sanitation and trash disposal 14. Clinical laboratory technical procedure manual.
■ Equipment for controlling air quality NCCLS approved guideline (GP2-A3). Wayne, PA:
National Committee for Clinical Laboratory Stan-
and pressure, humidity, and tempera- dards, 1996.
ture 15. Schlickman JJ. ISO 9000 quality management sys-
tem design. Milwaukee, WI: ASQ Quality Press,
■ Water systems 1998:3-20;69-80.
■ Toilet and hand-washing facilities 16. Ziebell LW. Process control. In: Ziebell LW,
An evaluation of the physical structure and Kavemeier K, eds. Quality control: A component of
process control in blood banking and transfusion
limitations of a facility is necessary prior to im- medicine. Bethesda, MD: AABB Press, 1999:
plementation of procedures or equipment to 1-12.
17. Code of federal regulations. Title 21 CFR Part 11.
ensure maximum efficiency and safety. A Washington, DC: US Government Printing Office,
more thorough discussion of safety can be 2001 (revised annually).
18. Code of federal regulations. 21CFR 600.3, 600.4,
found in Chapter 2. 606.3, 606.171. Washington, DC: US Govern-
ment Printing Office, 2001 (revised annually).
19. Motschman TL, Santrach PJ, Moore SB. Error/inci-
dent management and its practical application. In:
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pounds or that a low-volume unit was collected to offer autologous blood services without of-
■ Medical history with answers recorded as “yes” fering those services to individuals protected
or “no” for each question, with any pertinent ex- under the Americans with Disabilities Act.2
Documentation that the attending physician
planation
■ Identification of the interviewer has been notified if the units are positive for
■ Record of whether the donor was accepted evidence of infection due to a communicable
■ If the donor is deferred, reason and deferral pe- disease
Documentation of destruction of blood not re-
riod, with notation about temporary, indefinite,
or permanent deferral leased
■ Informed consent: ■ Apheresis (Cytapheresis and Plasmapheresis):
Consent to have blood drawn and tested The following record-keeping requirements are
An opportunity to exclude use for transfusion in addition to those that apply to Whole Blood do-
(if applicable) nation:
A statement that AIDS educational material is The name of the manufacturer and the lot
understood and an accurate medical history numbers and volumes of all solutions, soft-
has been given ware, and drugs used
The results of laboratory tests that qualify the
Permission for the blood bank to use blood as
it deems fit if unsuitable for transfusion and donor, time the procedure begins and ends,
signature of the donor the volume of blood processed, the volume of
■ Identification of the phlebotomist each component harvested, the estimated
■ The name of the manufacturer and lot number of blood cell loss, and any adverse events
Description of the procedure and informed
the container/anticoagulant
■ Record of whether the phlebotomy was satisfac-
consent
For apheresis donors who are given medica-
tory or unsatisfactory
■ Record of any donor reaction; symptoms, treat-
tions or are immunized, a separate informed
consent, as well as complete information on
ment, condition of the donor upon release; and
the drug or antigen source; the schedule, dos-
notation about whether the donor can be ac-
age, and route of administration; adverse
cepted again
Identification of person attending the donor
events; and response (eg, antibody titer) to
Time donor is released
the stimulating agent as measured by labora-
Notation if the donor refuses treatment or ad-
tory tests
All initial and periodic physical examinations
vice by a physician, including medical history in-
■ Documentation of postdonation information re-
terviews
ports Physician’s acceptance or rejection of the do-
Identity of the source of the information (eg,
nor, based on the accumulated laboratory data
from the donor, competent health-care pro- ■ Therapeutic Apheresis/Hematopoietic Progeni-
fessional) tor Cells:
Documentation of evaluation, investigation,
Physician’s order
and follow-up on these reports1 Patient identification
■ Documentation of implications in posttrans-
Diagnosis
fusion disease transmission
Appendix 1-4. Minimum Record Requirements (Donors and Donor Units) (cont’d)
Type of procedure performed ■ Name and volume of anticoagulant
Method used ■ Name of component
Extracorporeal blood volume ■ Date and time each component was prepared. (If
Nature and volume of component removed the preparation involves multiple steps such as
Nature and volume of replacement fluids separation, freezing, and thawing, documenta-
Any occurrence of adverse events tion of the time each step was performed.)
Medication administered ■ Date and time of component expiration
Informed consent ■ Volume of component, except for Cryoprecip-
■ Therapeutic phlebotomy: itated AHF and Red Blood Cells (RBCs) prepared
A record that the patient’s physician has or- in a routine manner from Whole Blood
dered phlebotomy ■ When recovered plasma is pooled for further
Volume of blood drawn manufacture, the donor unit number and the
Final disposition of unit identification of the collecting facility for each
If transfusion components are prepared, all unit in the pool
information required for blood donors ■ For pooled component labels:
Name of the pooled component
Tests on Donor Blood Samples Final volume of the pooled component
■ Donor unit number Name of the facility preparing the pooled com-
■ Reagents used, manufacturer, lot number, expi- ponent
ration date, control values and calculations if ap- Unique numeric or alphanumeric identifica-
plicable, and evidence that reagents have been tion
subjected to performance checks Number of units in the pool
■ Results and interpretation of ABO and Rh testing, ABO and Rh type of units in the pool
including the test for weak D if indicated
■ Results of tests for expected antibodies in the Labeling and Lot Release
ABO system ■ Documentation that ensures current, accurate
■ Results of positive and negative controls run with donor deferral registries have been checked and
the donor samples necessary action has been taken to prevent dis-
■ Results and interpretations of tests for the detec- tribution of unsuitable products
tion of unexpected antibodies, if indicated, in- ■ Documentation that verifies all records of test re-
cluding use of IgG-coated control cells if used sults are reviewed for completeness and accu-
■ Results and interpretation of serologic test for racy prior to labeling
syphilis ■ Identity of each component in quarantine to pre-
■ Results and interpretation of screening and sup- vent unsuitable units from being released
plemental tests for all infectious disease markers ■ Prior to release, documentation that the com-
and surrogate tests pletely labeled product has been examined for
Relevant calculations to define control and correct labeling. (This examination must be veri-
positive results. (The record of these calcula- fied by a second process.4)
tions may be kept separately from the results
of donor samples but must be readily associ- Disposition of Blood and Components
ated with specific sample records.) ■ Documentation and confirmation that all compo-
Record of incubation times and temperature nents from a unit have been quarantined, as indi-
Record of reason for invalidating a test result, cated; documentation of appropriate release
details of the investigation, records of super- from quarantine
visory review, outcome of the investigation, ■ When destruction is necessary, the identification
and, if indicated, any corrective action taken. of each of the components destroyed, reason for
(These records should be completed before destruction, date and method of destruction
any donor samples are retested.3) ■ When units are shipped, the shipping facility
■ Results and interpretation of tests that are per- must record the following information:
formed by outside testing laboratories, with the Name and address of receiving facility
name and location of the testing laboratory on Date and time of shipment
the record A list of each donor unit number, ABO and Rh
type, and expiration date
Component Preparation Name of each blood component
■ Donor unit number Results of final inspection of Whole Blood and
■ Date and, if appropriate, time drawn, and docu- components
mentation of method used (manual or automated)
Appendix 1-4. Minimum Record Requirements (Donors and Donor Units) (cont’d)
Name of person filling order tected; for reissued Whole Blood or components,
Periodic tests documenting that shipping a record that proper temperature has been main-
containers maintain an acceptable tempera- tained, that container and closure are intact and
ture range that inspection for abnormal color or appearance
is satisfactory
Blood and Components Received from Other Facil- ■ Notation of quarantine of unsatisfactory units,
ities record of any tests performed, and final disposi-
■ Name and address of shipping facility. (It is not tion of each unit
necessary to record the address with each unit if
this information is readily available.) Irradiated Blood and Components5
■ Name of blood component ■ Identification number of unit(s) irradiated
■ Donor unit number assigned by collecting facility ■ Identity of the source and strength, duration, and
■ Accession or inventory number, if any, assigned level/dose of irradiation
by receiving facility ■ Total dose of irradiation. If a product is irradiated
■ ABO and Rh type more than once, document the steps taken, indi-
■ Component expiration date and time, if indicated vidual irradiation dose, and the total (additive) ir-
■ Date component was received radiation dose
■ For blood that is received already crossmatched, ■ Temperature and length of time unit(s) out of
the name and identification number of the in- controlled storage
tended recipient and interpretation of results of ■ Identification of the operator and the date and
compatibility tests time of irradiation
■ Results and interpretation of tests done by the re- ■ New expiration assigned to component, when ap-
ceiving facility plicable
■ Inspection of incoming blood or components ■ Site of irradiation if the facility irradiating is dif-
■ Identification of receiving personnel ferent than the collecting facility
■ Quality control of the irradiating device, includ-
Storage and Inspection of Blood Components ing: results of irradiator indicator check for each
■ Central monitor listing every 4 hours of tempera- batch irradiated, calibration and monitoring of
tures, refrigerator identification, date, and time; dose delivered to the center of the container (cor-
or continuous monitoring chart for each piece of rected for air-liquid differences), turntable
equipment being monitored; or manual record- checks, timer checks, length of time required to
ing of time, temperatures, and staff identification deliver the radiation, records of calibration stud-
every 4 hours for each piece of equipment being ies conducted annually and after repairs, and ra-
monitored diation leak tests (eg, Geiger counting or wipe
■ Explanation of abnormal temperatures and ac- tests)
tion taken, and initials of personnel ■ Personnel training, including safety procedures
■ If components are stored in an open storage area, and radiation monitoring
ambient temperature recorded at least every 4 ■ Written agreement if product irradiation is to be
hours performed in a different facility (eg, hospital radi-
■ Records of periodic testing of alarm systems and ation therapy department) that specifies that the
backup power supply; comparisons of central irradiation of blood products is under the control
monitor readings with a calibrated reference of the blood establishment, and permits review of
thermometer training and audit by the blood establishment
■ Preissue inspections, date performed, unit num- ■ Monitoring personnel exposure to radiation
ber, and description of any abnormalities de-
1. Food and Drug Administration. Memorandum: Guidance regarding post donation information reports. (December
10, 1993). Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1993.
2. Pub. Law No. 101-336, 104 Stat. 327 (1990) codified at 42 U.S.C. §12101-12213.
3. Food and Drug Administration. Guidance for Industry: Revised recommendations regarding invalidation of test
results of licensed and 510(k)-cleared blood-borne pathogen assays used to test donors. (July 11, 2001). Rockville,
MD: CBER Office of Communication, Training, and Manufacturers Assistance, 2001.
4. Food and Drug Administration. Current good manufacturing practice in manufacturing, processing, packing, or
holding of drugs; revision of certain labeling controls. Final rule. Fed Regist 1993;58:147.
5. Food and Drug Administration. Guidance for Industry: Gamma irradiation of blood and blood components: A pilot
program for licensing. (March 15, 2000). Rockville, MD: CBER Office of Communication, Training, and
Manufacturers Assistance, 2000.
*Food and Drug Administration. Guidance for Industry. General principles of software validation: Final guidance for
industry and FDA staff. (January 11, 2002). Rockville, MD: CBER Office of Communication, Training, and
Manufacturers Assistance, 2002.
1. Food and Drug Administration. Guideline for quality assurance in blood establishments. (July 11, 1995). Rockville,
MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1995.
2. Food and Drug Administration. Memorandum: Changes in equipment for processing blood donor samples. (July 21,
1992). Rockville, MD: CBER Office of Communication, Training, and Manufacturers Assistance, 1992.
Management Data that May Prove Useful When Assessing Transfusion Services
1. Workload and productivity. Evaluation of activities and efficiency of the laboratory; may be analyzed by day
of week and by shift. Hours worked per unit transfused or patient transfused may be more valuable as an
efficiency measure than data obtained from traditional productivity calculations.
2. Event reports. Number of events dealing with laboratory processes (eg, labeling, preparation, testing, is-
sue); procedural events in blood administration; errors, accidents, and recalls by blood supplier(s).
3. Staff training and competency. Documentation of training and continuing competency of laboratory and
nursing staff to perform transfusion-related procedures and policies.
1. Comprehensive accreditation manual for hospitals: The official handbook. Oakbrook Terrace, IL: Joint Commission
Resources, Inc., 2002.
2. Guidelines for blood utilization review. Bethesda, MD: American Association of Blood Banks, 2001.