Quality and Compliance

Issues Part V

Chapter 23
Quality Management
Lucia M. Berte, MA, MT(ASCP)SBB, DLM, CQA(ASQ)CMQ/OE

Introduction Purchasing and Inventory Importance of a Facility Quality Management

Compliance Versus Quality Management Equipment System
Quality Building Blocks Process Management Summary Chart
Quality Control Documents and Records Review Questions
Quality Assurance Information Management References
Quality Management Systems Nonconformance Management Bibliography
Quality Management System Essentials Assessments
Organization Continual Improvement
Customer Focus A Quality Management System for Medical
Facilities and Safety Laboratories
Personnel The Cost of Quality

OBJECTIVES
1. Explain the differences between compliance and quality management.
2. List the three building blocks of quality.
3. Describe the framework of a quality system for a blood bank and a medical laboratory.
4. List 12 quality management system (QMS) essentials and the blood bank operations to which they are applied.
5. Describe a process using a flowchart.
6. Explain the role of validation in introducing a new process.
7. Name at least five blood bank process controls.
8. Describe the differences between a form and a record.
9. Explain the importance of document control for procedures.
10. State the differences between remedial and corrective action.
11. Describe the role of auditing in a QMS.
12. Identify at least six sources of input that can be used to improve processes.
13. Define the activities in a problem-solving process.
14. Describe the four types of quality costs.
15. Explain how to transition the QMS of a blood bank into that for a whole laboratory.

509
510 PART V Quality and Compliance Issues
Introduction
Several dictionaries define quality as “the degree to which
a product or service meets requirements.” Blood banks
must provide quality to their customers in many forms,
including:
• Safe, satisfying donation experiences for blood donors.
• Accurately labeled and tested blood components provided
to transfusion services.
• Timely, accurate transfusion services provided to physi-
cians and other health-care personnel.
• Safe and efficacious blood transfusions to patients.
Blood centers, hospital blood banks, and transfusion services
need to embrace the following quality philosophy to
ensure a high degree of safe blood donation and transfusion
practices to regulatory agencies, accrediting agencies, blood
donors, physicians, patients, and patients’ families:
Quality, safety, and effectiveness are built into a product;
quality cannot be inspected or tested into a product. Each
step in the process must be controlled to meet quality
standards.1
The method for bringing this quality philosophy into all
operations involves each facility developing the building
blocks of quality: quality control (QC), quality assurance
(QA), and quality management system (QMS). When the
building blocks are assembled, and the facility’s manage-
ment and staff are actively involved in monitoring and
maintaining the QMS, quality management (QM) has been
achieved.
Compliance Versus Quality
Management
Blood bank compliance with federal regulations and accred-
itation standards is required by the following organizations:
• United States Food and Drug Administration (FDA)2,3
• The Joint Commission4,5
• College of American Pathologists (CAP)6
• American Association of Blood Banks (AABB)7
Compliance programs evaluate how effectively the facility
meets the requirements by detecting errors, deficiencies,
and deviations. Compliance inspections (also called sur-
veys or assessments) measure the state of the facility’s pro-
gram with respect to the applicable requirements at a
single point in time and are usually conducted every 1 to
2 years. Although this process may seem logical, compli-
ance programs alone are inadequate to identify and prioritize
a facility’s problems.
Compliance simply requires the correction of identified
deviations and deficiencies and usually leaves the facility with
the false sense that it has solved its problems and has been
brought into compliance. However, subsequent inspections
often reveal the same deviations and deficiencies because
the facility’s current QC and QA programs do not identify the
fundamental quality problems. Remember that quality cannot
be inspected into a process; regulatory and accreditation
inspections only find deviations and deficiencies after they
occurred. Facilities need to design work processes in a way that
prevents deficiencies and errors from occurring in the first
place.
Quality management (QM) is actively and continuously
practiced by the blood bank’s leaders, managers, and staff
throughout all blood bank operations. With QM, the blood
bank is always ready for an inspection because it validates
its processes, monitors process performance, knows where
the problems are, continuously takes action to determine
root causes of problems and removes them, and documents
its actions. In QM organizations, quality is everyone’s job all
the time. Quality is not something we do in addition to our
jobs—it’s built into our jobs!
Quality Building Blocks
The building blocks of quality are quality control (QC),
quality assurance (QA), and quality management systems
(QMS). Figure 23–1 demonstrates these building blocks and
their internationally accepted definitions.8
Quality Control
Most blood bank technologists are familiar with routine blood
bank QC procedures, such as daily testing of the reactivity of
blood typing reagents; calibrating serologic centrifuges;
and monitoring temperatures of refrigerators, freezers, and
thawing devices. Requirements for the type and frequency of
QC are determined in regulations and accreditation standards,
manufacturers’ operator manuals and package inserts, and
state and local requirements. Regular performance of QC
reveals when a method, piece of equipment, or procedure is
not working as expected.
Quality
Management
Activities of the management function
that determine the quality policy
Organizational structure,
Quality procedures, processes,
System and resources needed to
implement quality management
Planned, systematic activities
Quality implemented within the quality
Assurance system to provide confidence
that requirements for quality
will be fulfilled
Quality Operational techniques and
activities used to fulfill the
Control requirements for quality
Figure 23–1. The building blocks of quality. (Definitions from International
Organization for Standardization: ISO 9000:2005 Quality management systems—
Fundamentals and vocabulary. International Organization for Standardization,
Geneva, 2005.)
 Chapter 23 Quality Management 511

Quality Assurance
BOX 23–1
QA is a set of planned actions that ensure that systems and Common Blood Bank QC Activities and QA Indicators
elements that influence the quality of the product or service
are working as expected, individually and collectively.8 QA QC Activities QA Indicators
looks beyond the performance of a test method or piece of Collection Equipment • Number of donor forms with
equipment; it addresses how well an entire process, which • Microhematocrit instrument incomplete or incorrect
is a sequence of activities, is functioning. This is particularly information
• Hemoglobin instrument
important in those processes that cross functional or depart- • Number and types of
• Apheresis equipment unusable units and blood
mental lines. For example, a blood center could monitor the • Blood-weighing scales components
number of times and reasons why a set of collected whole • Number of blood typing
Blood Components
blood units transported from the collection site to the discrepancies in donors and
component processing site did not arrive in time or was not • Red blood cell hematocrit patients
in an acceptable condition to make blood components. In • Cryoprecipitated • Number of and reasons for
antihemophilic factor invalid tests
the transfusion service, it is important to monitor the source,
• Platelet counts in platelet units • Number of and reasons for
the number of times, and the reason why specimens
• Residual leukocyte counts in labeling check failures
collected for compatibility testing do not meet predetermined leukocyte-reduced components
acceptance criteria. Box 23–1 lists common QC and QA • Number and source of
• Bacterial contamination of improper and incomplete
activities and indicators practiced by most blood banks.9 platelet units requests for blood
Reagents components
Quality Management Systems • Number and location of
• Copper sulfate patients without proper
A quality guideline published by the FDA10 set the meaning, • Reagent red blood cells identification at time of
emphasis, and organization of quality activities for blood • Reagent antisera specimen collection or
banks. Accrediting agencies such as the Joint Commission • Test kits for infectious disease transfusion
and AABB have established their quality requirements to be testing • Number of, source of, and
reasons for unacceptable
more comprehensive and more coordinated than either QC Laboratory Equipment specimens
or QA. A QMS provides a framework for applying quality • Heating instruments • Number of times wrong
principles and practices uniformly across all blood bank • Water baths component or ABO was
operations, starting with donor selection and proceeding • Thawing devices for blood selected for crossmatch
through transfusion outcomes. components or use
In its Standards for Blood Banks and Transfusion Services,8 • pH meters • Number and type of
the AABB defined quality system essentials (QSEs) for • Cell counters transfusion complications
blood collection and transfusion service facilities and the • Centrifuges, refrigerated and • Number of and reasons for
serologic turnaround time failures
blood bank operations to which they are applied. Box 23–2
lists the QSEs and blood bank operations on which the AABB • Cell washers
assesses blood banks in its accreditation program. • Blood irradiators
The next sections of this chapter describe the blood • Refrigerators
bank’s role and responsibilities in fulfilling QMS essentials, • Freezers
which extend far beyond historic QC and QA practices. • Platelet incubators
Figure 23–2 demonstrates that the QMS essentials are the • Blood warmers
building blocks that support blood bank operations in the • Shipping containers
path of workflow for both donor centers and transfusion
services.

Quality Management System
Essentials
The QMS essentials are in a logical order that can be
explained as follows for any new or changed product or
service. The blood center or transfusion service organization
develops its mission, vision, values, goals, and objectives
around the products and services it plans to offer. The facility
should have a customer focus by determining the needs and
expectations of its customers and designing its processes
and procedures to meet those needs and all regulatory and
accreditation requirements. The blood center or transfusion
service should have the physical facilities to support the
products and services offered and ensure that safety
requirements are met. The facility determines the qualifi-
cations needed for each job and hires qualified personnel
who are trained and who maintain competence in their
assigned duties.
Before products and services can be provided to cus-
tomers, equipment and materials need to be purchased and
maintained in inventory. Equipment needs to be managed
according to manufacturer, regulatory, and accreditation
requirements. Before any work can commence, the facility
needs to design, document, and validate work processes
with appropriate management to ensure their correct perform-
ance. Documents provide instructions for how the work
generates records of work performance. Patient and donor
information is managed in a way to ensure that requirements
512 PART V Quality and Compliance Issues

resources, and receives reports and information from all

BOX 23–2
QMS Essentials and Blood Bank Operations
QMS Essentials8
• Organization
• Facilities and safety
• Personnel
• Purchasing and inventory
• Equipment
• Process management
• Documents and records
• Nonconformance
management
• Assessments
• Continual improvement
Blood Bank Operations8
• Donor qualification
• Autologous donor qualification
• Apheresis donor qualification
• Blood collection
• Cytapheresis collection
• Preparation of components
• Testing of donor blood
• Final labeling
• Final inspection before
distribution
• Patient samples and requests
• Serologic confirmation of
donor blood ABO/D
• Pretransfusion testing of
patient blood
• Selection of compatible
blood and components
for transfusion
• Crossmatch
• Special considerations for
neonates
• Selection in special circum-
stances
• Issue for transfusion
• Blood administration
• Rh-immune globulin
hospital departments. The hospital-based blood bank or
transfusion service must participate in blood bank quality-
related activities, laboratory-wide quality initiatives, and the
hospital’s continual improvement program. The blood bank
should state in writing its policies, goals, and objectives for
each of the QMS essentials and relate them to the bigger
laboratory and hospital quality goals. There should be an
organizational chart showing the following:
• Relationships among blood bank personnel by job title
• The blood bank’s link to the laboratory
• The blood bank’s link to the hospital
• How the blood bank links to the hospital’s quality function
A freestanding blood center must develop and manage
the entirety of its QMS. There may be a quality council
represented by top-level management from the various
departments. The council develops the blood center’s QMS
policies, goals, and objectives and its strategies for QMS
implementation; provides resource support; prioritizes iden-
tified improvement projects; and provides support for cross-
functional process improvements. There may also be a
quality steering committee composed of senior managers
and department staff who operationalize the quality strategies
and implement process improvements.

for confidentiality and information integrity are met. The
process of capturing information on nonconformances is
managed to identify recurring process problems that can
affect patient safety, laboratory credibility, and the operating
budget. Internal and external assessments measure and mon-
itor the facility’s performance to identify opportunities for
improvement. The facility should constantly strive for
continual improvement.
Organization
The type and size of the organization determine the config-
uration of the blood bank’s QMS. In hospitals, there is
usually an organization-wide quality function or department
that prioritizes and coordinates quality projects, approves
Customer Focus
Although both blood centers and transfusion services toil on
behalf of patients, the real customers of these facilities is the
entity or person who receives and must be satisfied with a
product or service.8 For blood centers, the customers are the
donors, who want a safe and satisfying donation experience,
and the transfusion services served by the blood center,
which want properly tested and labeled blood components
of the appropriate types on demand. For transfusion services,
customers are the physicians, who want the blood transfu-
sions they order to occur in a timely manner, and the nurses,
who want the correctly issued blood components in a timely
manner for administration to patients. For all types of
facilities, internal customers are the employees.

A Quality Management System for the Blood Bank

Blood Bank Path of Workflow

Component Collections, Preparation, Testing, Labeling, Distribution, Compatibility Testing*, Issue, Administration

Quality System Essentials: The Building Blocks

The Blood Bank The Work The Performance

Organization Process Management Nonconformance Mgmt

Customer Focus Documents & Records Assessments
Facilities & Safety Information Management Continual Improvement
Personnel
Purchasing & Inventory
Equipment

*Links with Laboratory Path of Workflow, Figure 23-10

Figure 23–2. A quality system for the blood bank, showing the relationship of quality management system essentials to blood bank operations.
 Chapter 23 Quality Management 513

The important issue about having a customer focus is to

understand the customer’s needs and design the work BOX 23–3
processes and procedures to meet those needs. In addition Training for New Employees
to fulfilling customer needs, the processes and procedures
Orientation • Chemical hygiene program
must also meet regulatory and accreditation requirements.
• Organization • Hazardous waste disposal
• Department program
Facilities and Safety • Infection control (including
• Section
universal precautions,
In hospitals, the Joint Commission mandates an environ- Quality Training bioterrorism)
mental control program that addresses all significant envi- • Radiation safety, where
• Current good manufacturing
ronmental issues for facility management and maintenance practice (cGMP) applicable
such as temperature control, electrical safety, fire protection, • QMS Work Processes and
and so forth.4 The Joint Commission also requires that hos- • Team skills Procedures Training
pital laboratories have training programs for all laboratory • Problem-solving skills • Work processes performed on
personnel on emergency preparedness, chemical hygiene, the job
Computer Training
and infection control.4 Therefore, hospital-based blood • Procedures performed
banks and transfusion services are already participating in • Facility information system
(hospital, blood center) • New work processes and
facilities management and safety training. In addition, any procedures
• Department information
blood bank that performs irradiation of blood components • Revised work processes and
system (e.g., laboratory)
must also have a radiation safety program and document procedures
• Personal computers
appropriate training. Compliance Training
• E-mail
A freestanding blood center must develop its own facility • Medicare necessity
• Scheduling
management program. All regulations and accreditation requirements
• Online documentation
requirements for emergency preparedness, chemical hygiene, • Fraud and abuse reporting
infection control, and radiation safety training and documen- Safety Training
• Concerns about quality and
tation also apply. • Emergency preparedness safety
• Accident reporting
Personnel

Quality begins and ends with people. However, a quality

problem is seldom an individual employee’s fault. Rather, a
quality problem is almost always due to a faulty work
process. All the quality policies, goals, and objectives in the
world do not ensure safe and effective blood components
and transfusions unless the people involved in blood banking
know how their job fits into the organization, are trained to
know the work processes and procedures, and demonstrate
ongoing competence by doing it right the first time, every
time. Blood bank management needs to work with the blood
center’s or hospital’s human resources departments to define
qualifications for all blood bank jobs and to write job
descriptions that include educational qualifications, experi-
ence, and federal, state, and local licensing requirements,
where applicable, so that qualified persons can be hired.
Box 23–3 lists the major types of training that personnel
need to receive once they are hired. This training extends
significantly beyond only the task specifics of a particular
job. Periodic evaluation and documentation of the continuing
competence of personnel to perform their assigned job
functions and tasks is also required. Competence assessment
challenges can include direct observation of job task perform-
ance, review of records, and written, verbal, or practical tests.
Purchasing and Inventory
In hospital-based blood banks and transfusion services,
contract and purchasing issues are usually handled by the
hospital’s purchasing department. Blood bank personnel
may or may not have control over the specific vendors with
which the organization has agreements to purchase blood
components, reagents and kits for testing, equipment, and
other important supplies and materials. At a minimum,
hospital-based blood banks and transfusion services need
to have a process by which incoming blood components
and critical supplies are inspected and tested, where
required. In addition, blood banks and transfusion services
need to have effective processes for managing inventories
of reagents, supplies, and blood components.
Blood centers need to have specified processes for selecting
vendors of equipment, supplies, and services, and for entering
into and amending agreements. In addition, blood centers
must also have processes for receipt, inspection, and testing
(where required) of incoming critical materials (such as blood
bags and infectious disease testing kits), blood components
(such as leukocyte-reduced platelets), and blood products
(such as albumin, clotting factor concentrates, and immune
globulins).
Equipment
The blood bank needs to have a process for installing new
equipment and ensuring its proper functioning before it is
used in daily operations. Schedules for calibration, preventive
maintenance, and QC are required, with frequencies
determined by regulations, accreditation requirements,
manufacturers’ written instructions, usage, testing volume,
and equipment reliability. In addition to temperature-
controlled equipment (e.g., refrigerators, freezers, incubators),
514 PART V Quality and Compliance Issues
instruments such as automated analyzers, readers, pipettors,
and washers must also be installed and functioning properly
before routine use. Defective equipment and instruments
must be identified and repaired when necessary. Records
must be kept of all installation, calibration, maintenance, and
repair activities.
Process Management
A process can be defined as a set of interrelated resources
and activities that transforms inputs into outputs. Process
control is a set of activities that ensures a given work process
will keep operating in a state that is continuously able to
meet process goals without compromising the process itself.
Total process control is the evaluation of the performance
of a process, comparison of actual performance to a goal, and
action taken on any significant difference. Process control is
a means to build quality, safety, and effectiveness into the
product or service from the beginning. It is important to
understand and document the sequence of activities in a
process, develop and write procedures for the individual
activities, validate the entire process to ensure that it works
as expected before actual use, measure process parameters
to see that they stay in control, and understand when and
why the process has variations.
The FDA has published its requirements for process
control as the current Good Manufacturing Practices (cGMP)
that are cited in the Code of Federal Regulations.2,3 The
cGMP requires that facilities design their processes and pro-
cedures to ensure that blood components are manufactured
consistently to meet the quality standards appropriate for
their intended use.
Flowcharts
Figure 23–3 is a sequential flow of the elements of total
process control. An effective tool for understanding a process
is the flowchart. Flowcharts graphically represent the
sequence of activities in a process and show how the inputs
are converted into outputs. Flowcharts help to develop a
common understanding of a process. Mapping a facility’s
current work processes reveals bottlenecks; missing actions;
decision points; dead ends; and choices that can lead to
errors, delays, and unnecessary work. Mapping a new
process facilitates understanding of where human and other
resources will be needed for successful accomplishment.
Flowcharts can be created on paper or with commercially
available software programs. Figure 23–4 is a sample flow-
chart for the activities in the pretransfusion testing process.
It illustrates different decision points and test method
choices.
Standard Operating Procedures
A work process involves one or more persons who perform
a sequence of activities over a period of time. A process
flowchart describes “who does what and when” in a visual
manner and provides a big picture of “how it happens.” The
boxes in the flowchart represent activities performed by one
person; these activities need instructions that answer the
question, “How do I do this activity?”
Total Process Control
Process is flowcharted
Procedures are identified
Procedures are drafted
Process is validated
Procedures are finalized
Training is performed
Initial competence is assessed
Process performance is monitored
Figure 23–3. The sequential activities in total process control.
Standard operating procedures provide instructions for
each activity in the larger process. For example, the process
to provide a physician with a patient’s ABO and Rh type
involves ordering the test, collecting an appropriate specimen,
delivering it to the laboratory, performing the test, and
reporting the results. Different people order the test, collect
the specimen, perform the ABO/Rh test, and deliver the
results. In this process, there needs to be specific written
procedures for ordering tests manually or on the computer
system, collecting and labeling the blood specimen, delivering
the specimen to the laboratory, performing and recording the
ABO/Rh testing, and reporting the results.
Validation
To ensure that new processes will work as intended, they must
be validated before being put into use. Validation tests all
activities in a new process to ensure that the process will work
in the live environment. For example, when a new test for a
transfusion-transmitted disease is added to those performed on
donated blood units, the new test method—with its associated
instruments, test kits, computer functions, and procedures—
must be validated in each blood bank that will perform the new
test. The validation ensures that the new test will perform
as expected with that blood bank’s instrumentation, written
procedures, personnel, and computer systems. The culmination
of this activity is a validated process and set of new procedures
on which all personnel who will perform the new test must be
trained. Training must be documented and personnel deter-
mined to be competent in the new process and procedures
before they are implemented in the live environment.
 Chapter 23 Quality Management 515

Sample arrives

Sample and request are accessioned

Sample and request are evaluated

Red cell request is evaluated

Patient history is checked

Sample is processed

Automated
MANUAL TESTING AUTOMATED TESTING testing
process

ABO/D is done ANTIBODY SCREEN IS DONE

Or

Is there an Tube IAT screen Gel screen Solid phase screen

ABO or D
discrepancy?
Yes

ABO discrepancy is
resolved
and / or No
D discrepancy is
resolved Is the Yes
antibody screen and/or
positive?
Antibody Send
No identification out
process process
Are
red cell units
needed now? Yes

Crossmatch
No process
Sample and request are archived

Figure 23–4. An example of a flowchart for the pretransfusion testing process. (Adapted from Berte, LM (ed): Transfusion Service Manual of SOPs, Training Guides and
Competence Assessment Tools, 2nd ed. American Association of Blood Banks, Bethesda, MD, 2007.)

Process Controls Proficiency testing is another example of a process control.

It is essential to monitor processes to ensure that they
are performing as required, to correct process problems
before they affect output, and to improve processes to meet
changing needs and technology. Routine process controls
include:
• QC of test methods and reagents
• Review of work and QC records
• Capture of occurrences when the process did not perform
as expected
These routine process controls monitor whether a process is
functioning as needed.
In proficiency testing, one laboratory’s methods and proce-
dures are compared with those of other laboratories for the
ability to get the same result on a set of unknown specimens.
Regulations require that all laboratories participate in profi-
ciency testing for diagnostic laboratory testing. Blood bank
proficiency test challenges include serologic testing for blood
types, detecting and identifying unexpected antibodies,
checking compatibility of crossmatched blood, testing for
diseases transmitted through blood transfusion, and checking
for contamination of prepared blood components.
Other process controls include manual and automated
steps to prevent the occurrence of errors. One common
516 PART V Quality and Compliance Issues
process control in serologic testing is the use of green-
colored antiglobulin serum to ensure that the antiglobulin
serum was indeed added at the antiglobulin phase of testing.
Another common process control is the addition of IgG-
coated reagent red blood cells after the antiglobulin phase
reading to ensure that the antiglobulin serum was working.
Computer process controls include automatic comparison
of current blood type interpretation with the previous
computer records on the same donor or patient to prevent
ABO errors and warning signals when ABO-incompatible
units are issued for transfusion.
Documents and Records
Documents are approved information contained in a
written or electronic format. Documents define the QMS
for external inspectors and internal staff. Examples of
documents include written policies, process flowcharts,
procedures and instructions, forms, manufacturers’ pack-
age inserts, computer software and instrument operator
manuals, and copies of regulations and standards.
Records capture the results or outcomes of performing
procedures and testing on written forms or electronic
media, such as manual worksheets, instrument printouts,
tags, or labels. Both documents and records must be con-
trolled to provide evidence that regulations and standards
are being met.
Document Control
A structured document control system links a facility’s
policies, processes, and procedures and ensures that only
the latest approved copies of documents are available for
use. A typical document control system is structured as a
pyramid, as shown in Figure 23–5. The following example
best illustrates how a blood bank should link its policies,
processes, and procedures.
Quality Management System Documentation
Policy
(What will
be done)
Process
(How it happens)
Procedure
(How to do it)
Figure 23–5. A simple structure for organizing QMS documents.
The blood bank should have a written policy document
stating that the blood bank maintains a process and relevant
procedures for correcting erroneous entries or results on a
paper record or in the computer. A second document (such as
a process flowchart) should describe the sequence of activities
in identifying the need for a correction, obtaining any necessary
approvals for the changed information, making the correction
in the computer or on paper (or both), and notifying all
appropriate parties of the correction. Procedure documents
instruct staff members how to record the need for a correc-
tion, how to obtain any necessary approvals for making the
change, how to properly record a change to an entry on a
paper record, how to properly record a change to an entry in a
computer record, and how to notify appropriate parties of
the change and document the notification. The process and
procedures should be written in a way that ensures that all
regulatory and accreditation requirements are met. Recording
the actions taken throughout the process provides a tracking
record to provide evidence that the requirements were met.
The blood bank needs a system to control identification,
approval, revision, and archiving of its policies, process
descriptions, procedures, and related forms. The document
control system includes instructions for creating documents
in approved formats, assigning document identification and
version designation, approving new and revised documents,
preparing a master document list, and maintaining document
history files. This “change control” process usually requires
the completion and routing of a form that contains information
about the reason for a new document or a change to an
existing one. Other important change information includes
when the change was requested; who wants the change; what
other documents, if any, are affected by this change; and
dates for approval, training, and in-use.
A master copy of the new, approved version is added to
the master document history file, which contains copies of
all previous versions of that same document. The hard copies
within this master file capture the original signatures and
provide a paper backup when electronic files cannot be
accessed. The master document list is updated with the new
version number. When a revised version of a document
is ready for release, the distribution process needs to be
controlled to ensure that copies of the obsolete document
(e.g., procedures in a working manual) are replaced with the
new version and the obsolete copies destroyed. Employees
should not keep and refer to copies of procedures and forms
stashed in lockers, drawers, and personal files. Use of
unapproved, outdated documents could lead to errors or
omissions that could cause harm to patients.
Records Management
Forms are specially designed documents—either paper or
electronic—on which are recorded the results or outcomes
of performing a given procedure. Forms are subject to
the document control activities described in the previous
paragraph. The document identification system should
link the form to its respective procedure. Instructions for
completion of forms, when needed, can be conveniently
placed on the front or back side of the form. When a form

(either paper or electronic) is filled out, it becomes a record.
Regulations and accreditation requirements mandate the
review of records by authorized personnel and specify the
type of records and length of time they are stored for possible
future reference. State, local, and facility requirements for
record retention periods may also apply.
Information Management
Whereas documents provide information about what to do,
records tell what happened, who did it, and when it was
done. Information management activities include using and
manipulating the donor or patient information and test
results in the facility’s paper and electronic information
systems. For example, maintaining the confidentiality of
privileged donor and patient information is mandated by
government regulations,11 and the facility needs to ensure
its processes preserve that confidentiality. The facility must
also ensure the integrity of any data or information sent
inside or outside the facility, whether the medium used is
paper or electronic. For example, the facility needs to verify
that information faxed, e-mailed, or sent across instrument
and computer interfaces is identical to the original information.
Nonconformance Management
FDA regulations require that blood banks report any error
or accident in the manufacture of blood components that
may affect the safety, purity, potency, identity, or effectiveness
of the component or that compromises the safety of the
blood donor or recipient. Each blood bank must have a
process for detecting, reporting, evaluating, and correcting
deviations and any nonconformance with its own proce-
dures, products, or services. Nonconformance management
is one name for such a process. Other commonly used names
include occurrence, incident, or variation management.
Table 23–1 provides definitions of terms used to further
classify occurrences of nonconformance in blood banks.
Nonconformance Reporting
Information about events involving the blood bank that
deviate from accepted policy, process, or procedure need to
be captured and acted upon. Hospitals usually have a risk
management program in place; this program type typically
captures information about events involving patients and
visitors that could result in financial loss to the facility. An
internal blood bank nonconformance management system
captures and analyzes information about events that occurred
across the entire path of workflow for blood collection and
transfusion service activities whether or not a patient was
involved.
All employees need to participate in nonconformance
reporting. It is essential that staff not perceive nonconformance
reporting as a tool for finger-pointing or disciplinary action.
Instead, all staff needs to understand that nonconformances
represent blood bank processes that do not work as they
should, so knowledge of these problems provides opportuni-
ties for improvement. Nonconformances may be identified
Chapter 23 Quality Management 517
Table 23–1 Common Classifications
of Various Types of
Nonconformances
NONCONFORMANCE
TYPE DEFINITION
Accident Nonconformance generally not attribut-
able to a person’s mistake, such as a
power outage or an aged instrument’s
malfunction
Adverse reaction Complications that occurred to the donor
during or after the donation process
or to the recipient of transfused blood
components
Complaint Expression of dissatisfaction from
internal customers (physicians,
employees) or external customers
(donors, patients)
Discrepancy Difference or inconsistency in the
outcomes of a process, procedure,
or test results
Error Nonconformance attributable to a
human or system problem, such as
a problem from failure to follow
established procedure or a part of a
process that did not work as expected
Postdonation The receipt of information (call or
information letter) from a donor with
additional details regarding his or her
donation, such as subsequent illness
or neglecting to mention an illness or
medication
either by staff in the course of routine activities or by supervisors
during review of records. Complaints received in the blood
bank are also considered nonconformances. The facility needs
to capture information about all nonconformances, including
those identified before blood components are distributed or
issued. In the reporting process, employees describe the who,
where, and when and then briefly describe what happened
and what they did at the time to remediate the problem. A
standard report form can be used to capture information on
all occurrences of nonconformance (Fig. 23–6).
Investigation and Corrective Action
Supervisors and quality function personnel record the
nonconformances in a spreadsheet or database so that the
resolution process can be tracked. The nonconformances
are reviewed, investigated, and further classified as errors,
accidents, complaints, or another definition.
The immediate action, which is the initial quick-fix
solution, is known as remedial action. Such remedial actions
do not address the real cause of the problem, which can
be determined only through investigation. Investigation of
complaints or errors provides an opportunity to identify
underlying factors that contributed to the problem. Process
improvement tools (discussed later in this chapter) are
518 PART V Quality and Compliance Issues

NONCONFORMANCE REPORT FORM

Database number: __________________
ORIGINATOR: Reported by: ____________________________
Date and time occurred: _______________________________ Date and time discovered: _____________
Date and time reported: _______________________________

Explain the error / complaint / incident / nonconformance. Attach copies of any relevant records, as needed.

How was the error / complaint / incident / nonconformance discovered?

Describe what you did to take care of the immediate problem (remedial action):

INVESTIGATOR: Name: ________________________________

Findings of investigation: Attach copies of any related paperwork, as needed.

Will remedial action be effective in eliminating future nonconformances of this same type?
Circle one: Yes No

If no, what further action should be taken?

QUALITY DEPARTMENT: Name:________________________________ Date: _____________________

Is this nonconformance FDA reportable? Circle one: Yes No

If yes, initiate FDA-CBER report – see procedure.

What further action needs to be taken?

System, process, procedure, form change needed to reduce or eliminate recurrence:

DATABASE ADMINISTRATOR
Entered into database by: ______________________________________ Date: _____________________

Figure 23–6. An example of a nonconformance report form.

used to identify these contributing factors and to determine
the best way to remove them through implementing corrective
action.
Most corrective action involves making changes in the
process. All employees performing that process must then
be informed of the changes and retrained when necessary.
Sometimes the corrective action involves retraining only
specific individuals who may not have been adequately
trained initially or who have been taking unapproved
deviations from the established processes or procedures.
The nonconformance reporting process needs to be
clearly defined so that information is tracked and acted upon
and feedback is provided. The person responsible for the
quality function in the blood bank (usually called the QA
officer or quality manager) reviews all nonconformance
reports, assigns an accession number, and forwards the report
form to the sections or departments that will be involved
in the investigation. The completed report is returned to
the quality officer, who reviews it for completeness and
appropriateness of remedial and corrective action. If an
identified error or accident needs to be reported to the FDA,
the corresponding process is initiated.
In a good nonconformance management program, the
nonconformances are also mapped to the specific involved
processes in the blood bank’s workflow path. This infor-
mation is trended to determine which processes have the
most problems. Identifying problematic processes provides
significant support for defending when a process needs to
be changed. Facility staff must make a conscious decision
not simply to respond with remedial actions but also to use
nonconformance information for removing the underlying
root causes of the problem and to make improvements that
truly contribute to the safety and efficacy of transfusion
medicine.

Assessments
Assessments measure the state of a facility’s quality program
with respect to the applicable requirements at a single point
in time. There are internal and external assessments for
measuring and monitoring a facility’s performance to identify
opportunities for improvement.
Internal Assessments
Blood banks need to have processes in place to continuously
monitor the effectiveness of its QMS (see Fig. 23–2 for a
review of the QSEs supporting the blood bank’s workflow
path). Both the quality essentials and the facility’s specific
operations need to be assessed. Compliance inspection and
other checklists4–8 can be used as assessment tools; however,
these assess the adequacy of only the listed items. The quality
indicators monitored by hospital-based blood banks and
transfusion services as part of the laboratory’s QA program
are also helpful but do not usually cover all important
aspects of each operation.
Each blood bank should review all its processes and ask
the question, “What can we monitor on a scheduled basis to
ensure that this process is working as needed?” Quantitative
indicators can then be derived for which the numerator is
the number of times the process did or did not work, and
the denominator is the total number of times the process was
performed. Common transfusion service examples include
the percentage of specimens received in the compatibility
testing laboratory not acceptable for testing and the number
of times the transfusion service met its established turn-
around time for emergency release of uncrossmatched blood
to the emergency department (see Table 23–1 for additional
examples of quality indicators).
A very effective assessment tool is the internal audit.
Unlike compliance inspections, audits review a specific
facility process and determine—by examining documents and
records, interviews, and observations—whether the facility
is meeting the applicable requirements. For example, in a
retrospective audit of transfusion service records, an auditor
could randomly select a unit number for a red blood cell
component and track through each activity involved in how
the component was received, tested, issued, and transfused.
The training and competence assessment records of each
employee involved in handling the component are reviewed,
as are the QC records for the storage refrigerator and
the reagents, centrifuges, and other instruments used in
compatibility testing for that unit. The performance on the
proficiency test most recent to the unit’s testing is reviewed.
Copies of procedures and forms used at the workstations for
all testing and QC are examined to determine whether they
are the most current version, according to the master list.
Samples of records are reviewed for inclusion of all required
information, interpretations, and required supervisory
reviews.
For blood collection operations, a donor name or number
could be randomly selected and the same process repeated
for the donation record, computer files, all related procedures,
training and competence records, component production
Chapter 23 Quality Management 519
records, serologic and infectious disease testing records, and
related QC, labeling, storage, and shipping records.
When prospective audits are conducted, the auditor
watches the staff performing activities in the selected
process. The auditor may ask questions of staff members
such as, “How were you trained to perform this procedure
and when?” or “Where in the procedure are the instructions
for what you just did?”
Audits should be conducted by personnel who have
been trained to perform audits and to identify system prob-
lems. Auditors should not audit the procedures they per-
form in their jobs. In a hospital-based blood bank or
transfusion service, there may be insufficient personnel to
have a separate quality function, and the supervisor or
senior personnel or staff from another laboratory area may
have to perform some auditing activities. A freestanding
blood center should have sufficient personnel to designate
a quality officer and to separate the quality function from
routine operations.
The auditor presents his or her findings to the appropri-
ate management and operations personnel at the closing
meeting on a form similar to that in Figure 23–7. The
auditor may request corrective action for each finding. A
process should be in place for management personnel to
evaluate and review the audit to ensure that corrective
actions were implemented. Follow-up audits may be nec-
essary to ensure that the corrective action was successful
in removing the causes of the findings. Facilities must
prepare an annual summary of their audit findings and the
corrective actions taken.
External Assessments
There are two types of external assessments—proficiency
testing and external inspections. Proficiency testing is
a means to demonstrate that the facility’s testing processes
provide results comparable to those of other facilities with
the same instruments and methods. In proficiency testing,
the facility receives samples for testing from a designated
provider and performs the testing using its routine processes,
procedures, and staff. Results are compared to those of the
provider and the other laboratories and the facility gets a
report of its performance. Successful performance on profi-
ciency testing challenges is a requirement for laboratory
licensure and accreditation.12
The second type of external assessment is the external
inspection, performed by regulatory and accreditation
organizations for the purposes of obtaining and maintaining
the facility’s license or accreditation. External assessments
are periodically conducted by the FDA, the Joint Commission,
the CAP, and the AABB to determine the facility’s compliance
with the respective requirements.2–7,12
Continual Improvement
Information gathered from quality management activities
provides the facility’s leadership with a “report card” of how
well laboratory processes are functioning so that action can
be taken to improve any problematic processes.
520 PART V Quality and Compliance Issues

QUALITY ASSURANCE INTERNAL AUDIT

Area/Function Assessed

Subject Area: ________________________________________________ Date: _____________________

Key Positive Findings:

Key Opportunity Areas:

Recommendations for Improvements:

Auditors: ____________________________________________________ Date: _____________________

Response: Planned Actions and Completion Dates

Area Mgmt.: _________________________________________________ Date: _____________________

Approved by: ________________________________________________ Date: _____________________

Figure 23–7. An example of an internal audit form.

Identifying Opportunities for Improvement
Opportunities for improvement for both blood collection
facilities and transfusion services can be identified from
several main sources:
• The nonconformance trending process pointing to
operational areas that are not functioning as well as
intended
• Customer feedback such as complaints, solicited feedback,
or suggestions from external customers the facility serves
and from internal customers (employees)
• Information derived from monitoring quality indicators
of operations, particularly when it is compared with that
of peer groups in other institutions
• Internal audit feedback, whereby objective evidence
collected by the auditor should support the facility’s
understanding of why corrective action is needed and
should be taken
• Feedback from periodic external compliance inspections
(however, if the blood bank is already seriously involved
in the previous four activities, there should be little new
information learned of which the facility is not already
aware)
• Reports from other departments in the hospital’s
organization-wide quality committee function, such as
nursing or emergency department problems in dealing
with the blood bank
Using Teams
The hospital blood bank or laboratory’s quality committee,
or the blood center’s quality council, should set priorities for
the problems that need the most immediate attention. Many
organizations have successfully used teams to solve problems
or to design process improvements. Names such as process
improvement teams, quality action teams, continuous improve-
ment teams, and corrective action teams have all been used to
refer to groups of people representing different parts of a
given process who have been brought together to identify
and implement ways to remove the causes of the problem
and thereby improve the process. Teams need good team
 Chapter 23 Quality Management 521

skills to perform their assignments successfully. Team mem-

bers should receive team-building and problem-resolution BOX 23–4
training to ensure the most effective outcome for the time Appropriate Focus Points for Process Improvement
and resources expended.13 Common team dos and don’ts are Teams
listed in Box 23–4.
Teams Should Improve • Learning new skills,
Resolving Problems Processes That Affect: upgrading knowledge of
• Quality of product the business, developing
Many approaches to the problem-solving process have been
personal capabilities,
published. All the published problem-solving approaches • Quality and reliability of service team process
contain essentially the same activities of identifying problems, to internal and external customers
• Efficiency and accuracy of Teams Should Not
prioritizing, selecting the top-priority problem, collecting
job performance Work on These Issues:
data, analyzing the data, identifying possible solutions,
• Waste reduction, scrap, rework, • Problems governed by or
implementing the chosen solution, monitoring the perform-
and operating costs directly related to union
ance of the revised process, evaluating the effectiveness contracts
• Equipment performance,
of the implemented solution, and sustaining the gains. up-time, and reliability • Grievances and grievance
Figure 23–8 depicts one common approach to managing • Interdepartmental and procedures
the problem-solving process that includes these main intradepartmental • Seniority
activities:14 communications • Job classifications
• Improved process controls • Job assignments
• Developing a customer-oriented action plan
• Safety, hygiene, and work • Pay rates or benefits
• Putting the plan into action environment
• Measuring and monitoring to determine effectiveness of • Processes, procedures, training,
the action and competence
• Determining what to do based on the measurements

Plan-Do-Check-Act Process
Step1: Plan
A mission-consistent, customer-oriented action plan
• Identify opportunities for improvement from data sources
• Prioritize improvement activities
• Develop an action plan for the selected activity, either
- initiating a new process, or
- improving an existing process
• Identify
- customer needs
- participants
- timeframes
- outcome measurements
- success criteria
Step 2: Do
Put the plan into action
• Implement the action plan
- do a pilot project first
- broaden only after success
• Collect performance data
Step 3: Check
Has the planned and implemented change created intended improvement?
• Analyze collected data
• Compare performance data to established success targets and original performance data to
determine if improvement was achieved
• Identify any unexpected peripheral benefits
• Identify unanticipated problems in other areas
Step 4: Act
Decide what to do next
• Determine if customer needs were met
• Take action based on the results:
• Success:
- revise the processes for further improvements (optional), and
- assess again to determine if improvement is maintained, and
- if a pilot project, standardize to the bigger group
• Lack of success—re-do the action plan and repeat
Figure 23–8. Plan-Do-Check-Act Process. A common quality improvement process.
522 PART V Quality and Compliance Issues

Plan
• Determine product/service
specifications
• Provide products/services to
meet customer needs
• Prepare SOPs
• Define training requirements
• Describe process change
system
• Verify processes are reliable
and consistent
• Establish QC standards
Improve
• Train staff in use of
problem-solving methods
and tools
• Provide time to address Implement
problems • Appraise conformance to
• Provide information as standards
needed • Act on difference
• Monitor impact of process
improvements
• Recognize success
Assess
Perform on-going audits to
ensure:
• Design requirements are
met
• Process requirements are
met
• Finished product/services
meet specifications
• Finished product/services
meet customer needs
• All production activities are
controlled

Figure 23–9. The cycle of organization-wide quality management.

A formalized problem-resolution process is just one piece of
continual improvement. Figure 23–9 illustrates the whole
cycle that encourages continual improvement.
A Quality Management System for
Medical Laboratories
A laboratory-wide QMS can be derived by simply replacing
the blood bank path of workflow (see Fig. 23–2) with
the medical laboratory’s path of workflow, as shown in
Figure 23–10. All the quality system essentials (QSEs)
supporting the path of workflow remain the same because
these quality elements are universal. In fact, at the point of
compatibility testing in the blood bank path of workflow, the
laboratory’s (and transfusion service’s) path of workflow is
entered for all transfusion service testing.
A review of the International Organization for Standard-
ization quality standards demonstrates that blood bank
and laboratory QSEs are included in the international
standards.15,16 Therefore, all the discussion in the section on

A Quality Management System for the Laboratory

Laboratory Path of Workflow
Preanalytic Analytic Postanalytic

Test Order, Sample Collection, Transport, Receipt and Process, Testing, Reporting,Sample Archiving

Quality System Essentials: The Building Blocks

The Blood Bank The Work The Performance

Organization Process Management Nonconformance Mgmt

Customer Focus Documents & Records Assessments
Facilities & Safety Information Management Continual Improvement
Personnel
Purchasing & Inventory
Equipment

Figure 23–10. A QMS for the medical laboratory.


QSEs applies equally to hospital laboratories. It is not only
possible but also highly desirable to expand the blood bank’s
QMS building efforts so that the entire laboratory benefits
from improved organization, coordination, and effectiveness
of its many processes.17
The Cost of Quality
Although it may sound like much work and expense to
implement a QMS in a blood bank, transfusion service, or
medical laboratory, the costs involved are significantly lower
than the expenses the facility experiences when there are
major and minor nonconformances that need correction.
Expenses are multiplied when the same nonconformance
recurs and needs to be “fixed” again. A basic understanding
of the four different types of quality costs is vital to
comprehending the value of quality management to the
customers and patients served by the facility.18
Prevention Costs
The cost of implementing processes and controls to prevent
the occurrence of nonconformances is considered a “good”
quality cost. In the blood bank, transfusion service, and
medical laboratory, prevention costs include validation
activities, preventive maintenance, work process training,
and quality management activities such as improvement
teams and quality system training. A small amount of money
spent in these activities greatly reduces the chance of process
problems in the path of workflow that could compromise
the quality of the services provided or patient safety. Every
budget should contain funds for prevention activities.
Appraisal Costs
The cost of implementing processes and controls to appraise
or evaluate the blood bank, transfusion service, or medical
laboratory’s performance is also considered a “good” quality
cost. There are internal and external appraisal costs. Internal
evaluation costs include those for calibration materials and
reagents, equipment calibration, quality control materials
and reagents, any interim inspections of blood products or
records, and the internal audit program. External evaluation
costs include those for proficiency testing and periodic
licensure or accreditation inspections. The budget usually
always contains funds for these activities because they are
mandated by regulatory and accreditation agencies. Appraisal
helps ensure that problems are caught and corrected so as to
minimize any negative impact on customers and patients.
Internal Failure Costs
Internal failure costs are one of two costs considered to
be “bad” quality costs (the other is external failure costs).
Examples include discarded donated blood units, samples
Chapter 23 Quality Management 523
unacceptable for compatibility testing that need recollec-
tion, retesting when controls don’t give the proper results,
instrument failures, and downtime. Internal failures are
those caught and corrected before they adversely affect
customers or patients. However, operating funds have been
expended and wasted because the activity was not per-
formed correctly the first time. Additional operating funds
are then expended to correct the failure, thus eroding the
operating budget.
External Failure Costs
External failure costs are “bad” quality costs that are expensive
and hard to measure because they include both actual
and intangible costs incurred to correct a nonconformance
that has reached the customer. Examples of external failure
costs include customer complaint resolution, misdiagnoses,
recalls, and lawsuits. Consider the time, effort, and expense
involved in investigating nonconformances related to issuing
an erroneous report or blood component. The cost to correct
these and other “never” events greatly erodes the facility’s
operating budget and definitely erodes customer confidence
in the facility’s quality and credibility.
Reports have shown that some businesses waste up
to 40% of their operating budgets correcting internal and
external failures! Whereas there are no published data for
blood banks, transfusion services, and medical laboratories,
there is little reason to believe that the expenditures for
internal and external are significantly less. The important
issue is for a facility to identify its prevention, appraisal, and
internal and external failure costs and to use prevention and
appraisal activities to reduce failure costs wherever possible.
The old adage “An ounce of prevention is worth a pound of
cure” was never more appropriate!
Importance of a Facility Quality
Management System
Today, working in a QMS environment is needed to achieve
the standards of excellence necessary for surviving the
changes facing the nation’s health-care industry and providing
the level of patient safety that our donors and patients both
expect and deserve. Purchasers of health-care services want
evidence that health-care providers such as hospitals and
blood centers are involved in organization-wide quality
improvement programs that increase the safety of donors
and patients. Only those organizations demonstrating
measurable quality improvements are approved for agree-
ments for products and services. The cultural change needed
to create a QMS takes time, and organizations that have not
started must begin immediately to keep pace. Consumers of
blood center, hospital, and transfusion services accept no less
than total quality. Organizations that provide less will not
survive.
524 PART V Quality and Compliance Issues

SUMMARY CHART
Blood bank compliance with federal regulations and
accreditation requirements is mandated by the FDA,
the Joint Commission, the AABB, and the CAP.
Compliance inspections measure the state of the facility’s
program with respect to the applicable requirements at
a single point in time and are usually conducted every 1
to 2 years.
Quality control procedures in blood banking may
include daily testing of the reactivity of blood typing
reagents, positive and negative controls in infectious
disease testing, calibration of serologic centrifuges, and
temperature monitoring of refrigerators, freezers, and
thawing devices.
Quality assurance is a set of planned actions to provide
confidence that processes and activities that influence
the quality of the product or service are working as
expected individually and collectively.
A QMS provides a framework for uniformly applying
quality principles and practices across all blood bank
operations, starting with donor selection and proceeding
through transfusion outcomes.
Process control is a set of activities that ensures a given
process will keep operating in a state that is continuously
able to meet process goals without compromising the
process itself.
cGMP requires that facilities design their processes
and procedures to ensure that blood components are
manufactured consistently to meet the quality standards
appropriate for their intended use.
Process validation challenges all activities in a new
process before implementation to provide a high degree
of assurance that the process will work as intended.
Routine QC procedures, review of records, and capture
of nonconformances when the process did not perform
as expected are routine process control measures that
monitor whether a process is functioning as needed.
Nonconformance management is a name for processes
that detect, report, evaluate, and correct events in
blood bank operations that do not meet the facility’s
or other requirements.
An internal audit reviews a specific facility process and
determines—by examining documents and records,
interviews, and observations—whether the facility is
meeting applicable requirements and its own policies,
processes, and procedures.
A process improvement team is a group of people
who represent different activities in a given process
and who have been brought together to identify and
implement ways to solve process problems.

5. Which one statement below is correct?

Review Questions
a. A process describes how to perform a task.
1. A QMS is: b. A procedure simply states what the facility will do.
c. A procedure informs the reader how to perform a task.
a. Synonymous with compliance.
d. A policy can be flowcharted.
b. Active and continuous.
c. Part of quality control. 6. A blank form is a:
d. An evaluation of efficiency. a. Record.
2. QSEs are applied to: b. Procedure.
c. Flowchart.
a. Just the blood bank’s management staff.
d. Document.
b. Blood bank quality control activities.
c. Only blood component manufacturing. 7. An example of a remedial action is:
d. The blood bank’s path of workflow. a. Applying the problem-solving process.
3. cGMP refers to: b. Starting a process improvement team.
c. Resolving the immediate problem.
a. Regulations pertaining to laboratory safety.
d. Performing an internal audit.
b. Validation of testing.
c. Nonconformance reporting. 8. The PDCA cycle is used for:
d. Manufacturing blood components. a. Problem resolution.
4. Internal and external failure costs are: b. Process control.
c. Validation.
a. Readily identifiable in facility reports.
d. Auditing.
b. Controlled through prevention and appraisal.
c. Built into the facility’s operating budget.
d. Part of prevention and appraisal.

9. The difference between the blood bank and laboratory
QMSs is that:
a. The laboratory has a different path of workflow.
b. The blood bank does not include computer systems.
c. The QSEs are different.
d. The blood bank excludes testing.
10. The QSEs for the blood bank QMS can be used for the
laboratory because:
a. The paths of workflow are identical.
b. Both the laboratory and blood bank experience
accreditation inspections.
c. The QSEs are universal.
d. The QSEs are required by international standards.
References
1. Food and Drug Administration, Center for Biologics Evaluation
and Research: Guideline on General Principles of Process Vali-
dation. Food and Drug Administration, Rockville, MD, 2011.
2. Food and Drug Administration, Department of Health and
Human Services: Code of Federal Regulations, Title 21, Parts
200–299. U.S. Government Printing Office, Washington, DC,
revised annually.
3. Food and Drug Administration, Department of Health and
Human Services: Code of Federal Regulations, Title 21, Parts
600–799. U.S. Government Printing Office, Washington, DC,
revised annually.
4. The Joint Commission: Comprehensive Accreditation Manual
for Hospitals. Joint Commission Resources, Oakbrook Terrace,
IL, 2010.
5. The Joint Commission: Comprehensive Accreditation Manual
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Resources, Oakbrook Terrace, IL, 2010.
6. College of American Pathologists: Inspection Checklists for
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7. American Association of Blood Banks: Standards for Blood Banks
and Transfusion Services, 27th ed. American Association of
Blood Banks, Bethesda, MD, 2011.
8. International Organization for Standardization: ISO 9000:2005
Quality management systems—Fundamentals and vocabulary.
International Organization for Standardization, Geneva, 2005.
Chapter 23 Quality Management 525
9. American Association of Blood Banks: Technical Manual, 16th
ed. Bethesda, MD, 2008.
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tion and Research: Guideline on Quality Assurance in Blood
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11. Department of Health and Human Services: Code of Federal
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Salem, MA, 2003.
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15. International Organization for Standardization: ISO 9001:2008
Quality management systems—Requirements. International
Organization for Standardization, Geneva, 2008.
16. International Organization for Standardization: ISO 15189:2007
Medical laboratories—Particular requirements for quality and
competence. International Organization for Standardization,
Geneva, 2007.
17. Clinical and Laboratory Standards Institute: A Quality Man-
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Guideline, GP26, 4th ed. Wayne, PA, 2011.
18. Campanella, J (ed): Principles of Quality Costs: Principles,
Implementation, and Use, 3rd ed. American Society for Quality
Press, Milwaukee, WI, 1999.
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