Chapter 7
The Laboratory Quality Management Plan
This final chapter provides guidance in preparing and implementing a quality management
plan. Sample plans from three laboratories are included, and readers should feel free to excerpt
from these examples when developing plans for their own operations.
The CAP Laboratory Accreditation Program requires laboratories to maintain a written
plan that describes the overall quality management program of the laboratory.273 In 2004,
1.3% of laboratories inspected by the CAP were cited for not having an adequate quality
management plan.91
A quality management plan spells out the specific steps that a laboratory will take to
ensure that quality is being maintained. A well-constructed plan will be informed by material
in the previous chapters of this manual—case studies of quality failure, approaches to quality
management, regulatory and accreditation requirements, particular laboratory risks and control
measures, and feedback from customers and incidents.
Throughout this manual we have emphasized that laboratory quality and safety failures
may result from diverse causes, ranging from poor communication to human error and from
instrument failure to fraud. The laboratory director must ultimately choose which particular
quality and safety hazards a laboratory will address, and the controls that will be used to
mitigate each hazard. The laboratory’s quality management plan brings these decisions together
in a document that spells out the approach to managing quality and patient safety that will be
used in a particular organization.
Purpose
The purpose of the quality management plan is to describe the laboratory’s approach to the
management of quality and patient safety. A properly documented and implemented plan
will provide reasonable assurance that the laboratory (1) meets defined standards of quality
practice, (2) is in compliance with applicable laws and regulations related to quality and
patient safety, and (3) is engaged in credible quality improvement activities. A clinical
laboratory’s quality management plan will be of interest to laboratory owners, laboratory
users, external inspectors, and, potentially, to patients.
Some people have unrealistic expectations of what a quality management plan can
accomplish. They believe a plan can absolutely ensure the quality of every laboratory
operation, guarantee the accuracy of every laboratory report, and ensure complete and
continuous compliance with laws and regulations. However, the quality management plan
is primarily a system of controls, and all control systems have inherent limitations. Control
systems rely on judgments that may be faulty. Controls may be upset by breakdowns that
occur despite the existence of protective systems. Controls can be circumvented by collusion
between several individuals or by managers who choose to override control systems. Finally,
the design of any internal control system reflects resource constraints; controls will only be
implemented when their benefits are likely to exceed their costs. Therefore, a quality
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management plan can provide only reasonable assurance that the laboratory substantially
conforms to standards. It is not a guarantee.274
Authority
A quality management plan must be formally approved by the laboratory director on an
annual basis.275 This approval is normally evidenced by a signature. By approving a quality
plan, the laboratory director signifies that the activities described in the plan—if faithfully
executed—will reasonably ensure that the laboratory meets applicable quality and patient
safety standards and is committed to a program of quality improvement. If the director knows
of substantial quality deviations in laboratory operations that will not be detected or addressed
by a quality plan, the director should not approve the plan.
Some organizations require that individuals besides the laboratory director approve the
quality plan. Other individuals may approve quality plans, but the laboratory director must
also approve the plan to satisfy regulatory requirements. In 2004, 2.2% of laboratories
inspected by the CAP were cited because the quality management program had not been
reviewed for effectiveness during the previous year.91
Relation to Other Institutional Quality Programs
In small stand-alone clinical laboratories, the laboratory quality plan usually exists on its own.
In hospital-based laboratories, the laboratory quality plan may include a section that specifies
information that is to be reported to a higher-level authority, such as an institution-wide
quality committee. In very large operations, each section of the laboratory (eg, chemistry,
anatomic pathology) may have its own quality plan, and the implementation of the plan will
generate reports to a laboratory-wide quality officer or committee. In multi-site operations,
each testing site may have its own quality plan. The organizational level at which quality plans
are developed depends on the size and complexity of the laboratory and the nature of its
corporate ownership.
Plan Elements
What should be included in a quality plan? Certain elements are required by major accrediting
agencies,276 and we believe every plan should include several additional elements that have
been identified by the accounting profession as important components of management control
systems.25 We recommend the following elements be considered for inclusion in every quality
management plan.
A Commitment to Quality and Patient Safety
Quality and patient safety flourish in laboratories with the proper “tone.” This tone includes
an acceptance of standards, controls, discipline, structure, and responsibility. Management
should demonstrate that quality control and patient safety are taken seriously and create a
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work environment in which employees are encouraged to discuss quality and safety concerns
without fear of retribution. A statement to this effect within the laboratory quality plan helps
set the proper tone, although words alone are never enough.
Risk Assessment
The quality management plan should identify significant risks to quality and patient safety
that could impact laboratory operations. To some extent, CLIA regulations and the CAP
Laboratory Accreditation Program have already done 90% of the work required to identify
risks. The CAP LAP checklists (which incorporate relevant CLIA regulations) spell out
hundreds of problems that can interfere with the quality of laboratory operations, particularly
in the analytic phase of testing. These risks have been identified by experts in laboratory
medicine who are also familiar with the practical challenges of running a clinical laboratory.
The laboratory director participating in the CAP accreditation program need only be
concerned with the remaining 10%—risks that are unique to the director’s organization or
which local circumstances suggest require greater attention. In spelling out special local risks
to quality and safety, we suggest that authors of quality management plans focus on
(1) institutional priorities (perhaps the director’s institution has identified cancer care or heart
disease as a priority), (2) known problems with laboratory operations, (3) customer feedback,
and (4) recurring incidents or sentinel events. We believe the risk of fraud and malfeasance,
while small, needs to be addressed in a plan, and we suggest examples of how this risk can
be mitigated in one of our sample plans. There is a regulatory requirement that the quality
management plan must cover all aspects of a laboratory’s scope of care, such as inpatient
and outpatient services, reference laboratory services, satellite and point-of-care testing, and
consultative services. Therefore, risks should be identified for each area of service. There is
also a regulatory requirement that the quality management plan include all sections of the
laboratory and all shifts of operation.
In some institutions, a quality management plan contains a section called Quality Planning,
which includes the risk assessment activities discussed above as well as organized research into
customers needs and the development of products and services that meet those needs.
Control Activities
Control activities (sometimes called Quality Laboratory Practices) are the policies, processes,
procedures, and inventions that mitigate risks. For every significant risk, one or more control
activities should be in place. Control activities can take a variety of forms. For example, the
risk of receiving a bad lot of reagents is mitigated by a procedure to test each new lot of
reagents before placing the lot into service (as well as other controls). The risk of someone
misappropriating private health information is mitigated by the requirement that passwords be
used to access laboratory computer systems (as well as other controls). Most control measures
are spelled out in individual procedures; there is no need to repeat in the plan every control
activity that is already described elsewhere. When not specified in other documents, the
quality management plan should include a description of the control activities that the
laboratory will follow to address a particular hazard. Controls applied to broad laboratory
issues, such as turnaround time or specimen collection, often are described in quality
management plans.
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Information and Communication
If not described in other procedures, the quality management plan should specify how quality
and safety information is to be collected and disseminated. This is particularly important for
quality monitors that bridge traditional organizational boundaries. The frequency of data
collection, sources of information, and any calculations should be specified in the plan or a
separate procedure. If each section of a laboratory has its own quality plan, the information
that will be sent “upstream” to the laboratory director or laboratory-wide quality committee
should be specified. It may also be necessary to provide instructions for communicating with
an institution-wide quality committee and with suppliers or customers who are to receive
reports from the laboratory.
Monitoring
Internal control systems need to be monitored; that is, the performance of laboratory
operations over time and the internal control system itself need to be periodically reviewed.
At least three types of monitoring are performed and should be spelled out in a quality
management plan:
❖ First, complaints, incidents, and sentinel events should be reviewed. There must be an
organized program for documentation of external complaints and internal problems
involving the laboratory. Any problem that could potentially interfere with patient care
must be addressed, and the laboratory must document investigation and resolution of
the problem. For JCAHO-accredited hospitals, there is a regulatory requirement that all
sentinel events be investigated with a root cause analysis. The laboratory must be able to
demonstrate that it has implemented any appropriate risk-reduction activities based on
root cause analyses of sentinel events.
❖ Second, the results of ongoing measurement activities should be compared with
internal or external benchmarks and trended over time. If performance is significantly
worse than a laboratory’s past performance or industry norms, it is likely that processes
or procedures will need to be changed.
❖ Finally, the quality management plan itself requires regular (at least annual) review. The
plan need not be changed every year but should be reviewed annually and kept current,
as required. The annual review should be documented.
Continuous Improvement
A quality operation is committed to continuous improvement. At any point in time, some
aspects of laboratory operations should be explicitly targeted for improvement. The actions
that are planned to improve performance should be documented in the plan, and the effects
of past quality improvement efforts (successful or unsuccessful) should be documented. In an
organization committed to continuous improvement, small changes to operations are made
daily, often without lengthy or formal planning, to make processes work better. There is no
need to document these sorts of activities in an annual quality management plan. The plan
should focus on major quality improvement activities that extend over longer periods of time
and are more far-reaching.
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Format of the Plan
There is no required format for a quality management plan. The plan may be of the laboratory’s
own design, or it may follow a reference resource, such as CLSI guideline GP-22, Continuous
Quality Improvement: Integrating Five Key Quality System Components, or GP-26, Application
of a Quality Management System Model for Laboratory Services; the ISO 9000 series; JCAHO’s
model for improving organizational performance; or the AABB quality program. The document
need not be detailed, but it should itemize the essential aspects of the program. For a small
office-based laboratory, the quality management plan may be as short as two typed pages in
length; for a large laboratory, it may be several dozen pages long.
The quality management plan should contain all of the required elements listed in
preceding sections of this chapter or should reference the procedures that contain the required
elements. For example, the plan should either spell out the approach that will be used to
investigate and address complaints that could affect patient care or should reference a separate
procedure that contains this information.
The plan can exist as a separate document, or it can be a single procedure within a larger
laboratory procedure manual. One advantage of making the quality management plan a
procedure within a larger manual is that the plan will be reviewed automatically as part of the
annual review of the laboratory procedure manual.
Some organizations maintain a separate patient safety plan. We have incorporated patient
safety considerations into our sample quality management plans because combining the two
reduces paperwork and is consistent with our general philosophy that assuring patient safety
is part of quality management. Some organizations may prefer to address patient safety in a
separate document.
Implementing the Plan
A quality management plan that is not implemented has little value. Moreover, the CAP
accreditation standards require that the plan be implemented as designed.277 In 2004, 1.6% of
laboratories inspected by the CAP were cited for not implementing their quality management
plans.91 The authors of this manual share deep concerns about laboratory managers who create
beautiful paper documents that never come to life. Lest we lose site of our goal, it is worth
reminding ourselves that the purpose of quality management is to foster quality, not the
creation of quality plans.
How do plans become practice? Often it is helpful to make specific individuals responsible
for each task spelled out in the plan. Milestones and deadlines may be specified. Responsible
individuals should also be given sufficient time to carry out assigned tasks. Insufficient time
devoted to quality monitoring activities may result in incomplete or misleading information.
Many laboratories create a quality committee that meets regularly to receive reports of ongoing
measurements and to review complaints, problems, and any sentinel events. Social pressure
from the quality committee helps motivate responsible individuals to complete required tasks.
Evidence of plan implementation includes the minutes of the quality committee, the
results of ongoing measurement, and any documentation related to complaint investigation,
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problems, and adverse events. These records, along with the plan itself, should be available to
external inspectors. Quality management record-keeping need not be centralized, but on the
day of a CAP inspection, summaries of all QM records should be grouped and provided to the
inspector.
In our experience, plans are most easily implemented when a culture of safety and quality
already exists within an organization. There are many authors and consultants ready to help
managers cultivate a culture of safety and quality. Unfortunately, most approaches to promoting
the right culture have not been scientifically tested, and we are reluctant to recommend
specific techniques, even as we acknowledge the central importance of organizational culture
to successful plan implementation.
Sample Plans
Three sample quality management plans are provided. These samples are based on real plans
in current use, but the names of the laboratories from which they have been borrowed and
some laboratory-specific information have been changed. The samples included in this manual
are significantly longer than many quality management plans. Shorter plans that are well
constructed can meet regulatory requirements as well as these samples.
The first plan serves a fictitious 145-employee laboratory located within a Florida
community hospital. The second plan serves a microbiology section of a large free-standing
laboratory in Oklahoma, where each laboratory section maintains its own quality management
plan. The third plan serves a fictitious academic medical center in California.
The three samples address all of the elements we believe should be included in a quality
management plan. Yet each plan describes the laboratory’s quality program in its own way.
To conserve space, only the most significant portions of the sample plans are included in this
manual. Readers should feel free to borrow sections from any of these examples.
❖ ❖❖
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