Laboratory Management

Week 14-15: Quality Management

QUALITY MANAGEMENT SYSTEM

Quality Management System (QMS) is a management approach that requires the
management as well as the laboratory administration to be fully on board so that
the entire testing process, including its technical aspects, meets quality
requirements. The development of QMS in all aspects of a laboratory’s working
and organization, such as quality planning (QP), quality assurance (QA), quality
control (QC), as well as continuous quality improvement (CQI) processes requires
total focus.
 
Quality planning ensures the control of quality. It ensures that policies,
infrastructure, equipment, environment, and personnel requirements are met
before a testing procedure is undertaken.
 
Quality assurance stresses the anticipation and detection of errors before a test
report is released. Two key principles characterize QA: “Fit for purpose” (the test
is suitable for the intended purpose) and “the right first time and right every
time” (errors are eliminated before they occur).
           
It incorporates all three phases – works that need to be done before testing (pre-
analytical), during testing (analytical), and after completion of a test procedure
(post-analytical). In all three phases, QA should be planned and implemented
without any deviation. In the pre-analytical phase, collection, transportation, and
storage of specimens; In the analytical phase, the quality of diagnostic kits and
reagents, maintenance and calibration of laboratory equipment, environmental
control, testing procedures, and technical skill; and in the post-analytical phase,
the correct interpretation of results, their transcription and communication to the
appropriate person within a stipulated time (turnaround time).
 
It is generally seen that maximum effort is applied to the analytical phase of
quality assurance, even though it is well known that most errors occur during the
pre and post-analytical phases. Nevertheless, QA alone cannot guarantee the
quality of test results. It can be best summarized as the right result, at the right
time, on the right specimen, from the right patient, with the right result
interpretation based on correct reference data and delivered at the right cost.
 
Quality control refers to the institution of appropriate checks during the testing
procedures and constant monitoring of testing processes. While QA is process-
oriented and focuses on error prevention, QC is test-oriented and focuses on
error identification. It primarily concerns the control of errors in the performance
of tests and verification of test results, that is, the analytical phase of QA. Internal
quality control (IQC) and external quality assessment (EQA) are the two key pillars
of QC. They enable the laboratory to evaluate itself with both internal and
external resources and expertise. IQC is performed with both internal controls
provided by the manufacturer of test kits, as well as external controls procured or
prepared by the laboratory. The results of the tests performed on patient
specimens are validated based on the results of these controls. EQA provides
validation of test results between laboratories. It allows a comprehensive analysis
of results and discrepancies. Root cause analysis of discordant results ensures
that errors are corrected.
 
Continual quality improvement is aimed at the creation of an attitude that
continuously analyses capabilities and processes intending to deliver quality test
results. It is based on the premise that it is possible to achieve continual
improvement through small, incremental changes using scientific methods.
Documentation at all levels is the essence of a good QMS. If the procedure or
process is not documented; it is presumed to have not been performed.
 

 A diagrammatic representation (Figure 1) explains the relationship between QC,

QA, and QMS.
 Figure 1: Relationship between QC, QA, and QMS
 

Quality system
In an industrial unit, raw materials (input) are processed and transformed into a
product (output). A process is defined as the total of activities that use resources
to transform inputs into outputs. The process may consist of several procedures.
A procedure is a specified way to carry out an activity. Each procedure is
undertaken in such a way that it delivers the desired result through a systems
approach. Quality is ensured through a well-defined quality system.

Health laboratories also work on similar principles. The clinical (or environmental)
material constitutes the raw material (inputs) which is processed in the laboratory
to generate an output in the form of a report. Health laboratories also strive to
assure the quality of their product (report). However, quality does not just
happen on its own. Systematic efforts in the organizational structure and efficient
utilization of resources are needed to implement all the steps that will assure the
generation of quality reports by the laboratories. Quality System is a part of
overall quality management that aims at ensuring consistency, reproducibility,
traceability, and efficaciousness of the products or services.
 
Accordingly, a quality system is defined as the organizational structure and
resources needed to implement quality requirements. ISO defines the quality
system as the organizational structure, responsibilities, procedures, processes,
and resources needed for implementing quality management.
Key elements
The quality system consists of the following five key elements:
      Organizational management and structure.

      Referential (quality) standards and validation.

       Documentation
     Assessment (Monitoring and evaluation).
      Training
Organizational Management and Structure
The overall responsibility for the design, implementation, maintenance and
improvements in the quality system rests with the laboratory management.
Quality is the responsibility of all the staff members of the organization. However,
the top management needs to make a firm commitment to ensure quality and
allocate adequate resources. The quality policy reflects the intention and
commitment of the organization to attain quality. The policy can be translated
into implementation through a quality plan which, along with policy, needs to be
documented in the form of a quality manual.
 
Laboratory management delegates responsibility and authority to appropriate
individuals who are directly responsible for implementing the quality policy and
quality system and makes available adequate resources to efficiently discharge
their duties.
 
The management also makes all decisions and strategies with quality as the
overarching theme. Resources and size of the organization permitting, a Quality
Manager can be appointed to supervise and guide all activities related to the
implementation of quality. In smaller laboratories, a staff member can be given
the additional responsibility of a “quality manager”.
 
Referential (Quality) Standards and Validation
Referential standards are an integral part of the quality system. They are aimed at
ensuring safety and consistency. These need to be followed to meet regulatory
requirements as well as monitoring the functioning of the laboratory.
 
Both management and technical standards need to be followed to ensure quality.
These must also conform to local laws.
 
Validation is that part of a quality system that evaluates in advance the steps
involved in operational procedures or product preparation to ensure quality,
effectiveness, and reliability.
 
Documentation
Documentation is information that provides directions or instructions, including
policy statements, quality manuals, procedures, specifications, calibration tables,
reports, job descriptions, documents of external origin such as regulations,
guidelines and examination procedures, and user manuals of equipment. These
may be delivered through various media, such as hard copy or electronic copy.
 
The quality system of the laboratory shall define, document, and maintain
procedures to control all documents and information (from internal and external
resources). The current version of relevant documents shall be available at all
locations where operations needed for the effective functioning of the quality
system are performed. Records should be archived for the chosen period
following national and specific regulations and must be easily retrievable.
 

Assessment, Monitoring, and Evaluation

The laboratory management shall develop and implement quality indicators to
systematically monitor and evaluate the laboratory’s contribution to patient care.
When the program identifies opportunities for improvement within the system,
the laboratory management shall take appropriate steps to address them. Error
management shall be vigorously implemented.
 
Assessment of quality through audits (internal or external) and participation in
external quality assessment schemes are other tools, the results of which should
guide the management in further improving the quality.
 
Training
The quality system is only as good as the staff who actually work with it. No
matter how good the quality system is on paper if the theory cannot be translated
into practice, quality cannot be achieved. Training must also include an
understanding of why quality is important. Training should be competency-based
and must be followed by post-training support. The objective of the training is to
close the gap between theory and practice.
 
The existence of a quality system demonstrates that the laboratory has:
       Commitment to quality.

       A definite program for quality and its continuous improvement.

      Methods for processing laboratory specimens in the form of approved

written SOP.
      Evidence-based control systems.

      Appropriate documentation.

     Trained human resource.

    The mechanism for error management to detect how, when, and where
things have gone wrong and take necessary actions to prevent their
recurrence.
Development of a Quality System
The development of a quality system can be done in a stepwise approach as
shown in the following figure.
 
QUALITY ASSESSMENT—ERROR ANALYSIS
Two types of errors occur in error analysis: active error and latent error. An active
error is obvious. It occurs at the interface between a health care worker and the
patient (Box 1). In comparison, a latent error is less obvious. Latent failures are
related to the organization or design of a laboratory (Box 2). Ways to improve
overall errors include at least three strategies:

1.         Formal patient safety training, including discussion of the disconnect

between laboratory personnel and the patient
2.         Enhanced communication between patients and laboratory staff and
providers directly caring for patients
3.     Quality improvement projects that involve patient outcomes data and
feedback of the data to laboratory staff, with an analysis of the
consequences of high-quality and low-quality work.
 BOX 1: Examples of Active Errors
       Failing to identify a patient before phlebotomy
       Missing blood vessel during phlebotomy
       Errors with collection tubes
       Errors with transportation system (such as a pneumatic tube)
       Errors with data entry
       Errors with instrument or computer (such as ignoring instrument flag)
 

BOX 2: Examples of Latent Errors

       Staffing problems (such as chronic shortages)
       Information technology (such as no interface with technology)
       Equipment malfunctions (such as old error-prone analyzers)
       Work environment (such as multitasking, poor lab layout, and disconnect
between lab and patients)
       Policy and procedures (such as the relabeling of mislabeled or unlabeled
tubes and lab requisition variation)
       Teamwork factors (such as poor communication between shifts and
departmental “silos”)
       Management/organization (such as when profit is a goal, ignoring patient
safety, and deemphasis on incident reports and interventions based on
analysis)
 

QUALITY ASSESSMENT—PHASES OF TESTING

The total testing process (TTP) serves as the primary point of reference for
focusing on quality in the clinical laboratory. TTP is defined by activities in three
distinct phases related to workflow outside and inside the laboratory:

1.      Preanalytical (pre-examination)
2.      Analytical (examination)
3.     Postanalytical (post-examination)
Currently, the majority of laboratory errors are related to the pre-examination or
post-examination phases of testing rather than the examination phase. Specimen-
related errors continue to be a major problem (Fig.1), leading to unnecessary
costs to hospitals.

FIGURE 1: Clinical laboratory testing errors. A,  Preanalytical errors are 46% to
68.2% of total errors. B, Postanalytical errors are 18.5% to 47% of total errors.
To reduce and potentially eliminate laboratory errors, a QA program is mandated.
A QA program can be divided into two major components: nonanalytical factors
and the analysis of quantitative data (QC). CAP includes a variety of
considerations in QA management (Box 3). The Institute for Quality Laboratory
Medicine (IQLM) has developed 12 measures to evaluate quality in the
laboratory, based on the phase of testing (Boxes 4 and 5).
 
BOX 3 CAP Quality Assessment Considerations
       Supervision
       Procedure manual
       Specimen collection and handling
       Results reporting
       Reagents, calibration, and standards
       Controls
       Instruments and equipment
       Personnel
       Physical facilities
       Laboratory safety
 

BOX 4: IQLM Proposed Quality Assessment Measures

Preanalytical (Pre-examination) Phase
       Test order accuracy
       Patient identification
       Blood culture contamination
Test System/Preanalytical (Pre-examination)
       Adequacy of specimen information
Analytical Phase (Examination)
       Accuracy of point-of-care testing
       Cervical cytology/biopsy correlation
Test System/Analytical (Examination)
       Diabetes monitoring
       Hyperlipidemia screening
Postanalytical (Post-examination) Phase
       Critical value reporting
       Turnaround time
Test System/Postanalytical (Post-examination)
       Clinician satisfaction
       Clinician follow-up
 

 
BOX 5: Examples of Potential Preanalytical, Analytical, and Postanalytical Errors

Preanalytical (Pre-examination)
Specimen obtained from the wrong patient
Specimen procured at the wrong time
Specimen collected in the wrong tube or container
Blood specimens collected in the wrong order
 Incorrect labeling of specimen
Improper processing of the specimen
 
Analytical (Examination)
Oversight of instrument flags
Out-of-control quality control results
The wrong assay performed
 
Postanalytical (Post-examination)
Verbal reporting of results
Instrument: laboratory information system (LIS) incompatibility error
Confusion about reference ranges
 

Nonanalytical Factors in Quality Assessment

To guarantee the highest-quality laboratory results and to comply with CLIA
regulations, a variety of preanalytical and post-analytical factors need to be
considered. Nonanalytical factors that support quality testing include the
following:

1.       Qualified personnel
2.       Established laboratory policies
3.       Laboratory procedure manual
4.      Test requisitioning
5.      Patient identification, specimen procurement, and labeling
6.      Proper procedures for specimen collection and storage
7.      Specimen transportation and processing
8.      Preventive maintenance of equipment
9.      Appropriate methodology
 
QUALITY CONTROL
Assaying control specimens and standards along with patient specimens serves
the following major functions:

1.        Provides a guide to the functioning of equipment, reagents, and

individual technique.
2.       Confirms the accuracy of testing when compared with reference values.
3.       Detects an increase in the frequency of both high and low minimally
acceptable values (dispersion).
4.       Detects any progressive drift of values to one side of the average value
for at least 3 days (trends).
5.       Demonstrates an abrupt shift or change from the established average
value for 3 days in a row (shift).
QC oversees each procedure for an established protocol to ensure the quality of
the results. Usually, normal and abnormal control samples are analyzed at the
same time patient specimens are analyzed.
 
Accuracy versus Precision
The accuracy of a procedure refers to the closeness of the result obtained to the
true or actual value (Fig 2, whereas precision refers to repeatability, or
reproducibility, of obtaining the same value in subsequent tests on the same
sample (Fig.3). It is possible to have great precision, with all laboratory personnel
who perform the same procedure arriving at the same answer, but without
accuracy, if the answer does not represent the actual value being tested. The
precision of a test, or its reproducibility, may be expressed as standard deviation
(SD) or the derived coefficient of variation (CV). A procedure may be extremely
accurate but so difficult to perform that laboratory personnel is unable to arrive
at values close enough to be clinically meaningful.
 

In general terms, accuracy can be aided by the use of properly standardized

procedures, statistically valid comparisons of new methods with established
reference methods, the use of samples of known values (controls), and
participation in PT programs.
 
 FIGURE 2: Accuracy
 

FIGURE 3: Precision.
 

Precision can be ensured by the proper inclusion of standards, reference samples,

or control solutions; statistically valid replicate determinations of a single sample;
and duplicate determinations of sufficient numbers of unknown samples. Day-to-
day and between-run precision is measured by the inclusion of control specimens.
 
Sensitivity and Specificity of a Test
Laboratory results that give medically useful information, including the specificity
and sensitivity of the tests being ordered and reported, are important. Both
specificity and sensitivity are desirable characteristics for a test, but in different
clinical situations, one is generally preferred over the other.
 
For assessing the sensitivity and specificity of a test, four categories are needed:
tests positive, tests negative, disease present (positive), and disease absent
(negative). True positives are those patients who have a positive test result and
who also have the disease in question. True negatives represent those who have a
negative test result and who do not have the disease. False positives are those
patients who have a positive test result but do not have the disease. False
negatives are those who have a negative test result but do have the disease.
 
MONITORING QUALITY CONTROL
Levey-Jennings Charts
Most laboratories plot the daily control specimen values on a QC chart. Currently,
many instruments automatically generate QC charts on each day of testing. Out-
of-control specimen results are automatically flagged. If an instrument does not
generate QC charts, the laboratory professional must perform this task (Student
Procedure Worksheet 3-1).
 
Levey-Jennings (Shewhart) QC plots have traditionally been used to identify
unacceptable runs and then evaluate the source and magnitude of the deviation
to decide if results are to be released to patient charts. Software designed for
laboratory information systems and personal computers is available to automate
the plotting of control values. The software’s complexity and capabilities (for
multiple QC options) will vary among suppliers, but all typically provide a
graphical presentation of data using the traditional Levey-Jennings chart. The
main purpose of control charting in the clinical laboratory is to aid in maintaining
the stability of the analytical measuring system.
 
 Levey-Jennings quality control (QC) chart. (From Kaplan LA, Pesce AJ: Clinical
chemistry: theory, analysis, correlation,  ed 5, St Louis, 2010, Elsevier/Mosby.)
 
Shifts, Trends, and Dispersion
     Regular visual inspection of the control chart is useful for observing a
shift, trend, or increased dispersion of results in the assay results of the
control specimen.
     A shift is defined as a sudden and sustained change in one direction in
control sample values. A trend or drift is a gradual change in the control
sample results.
      A systematic drift or trend is displayed when the control value direction
moves progressively in one direction from the mean for at least 3 days.
     By comparison, dispersion is observed when a random error or lack of
precision increases. Each type of change is indicative of particular
problems. A shift or abrupt change may be observed with the sudden
malfunction of an instrument. A trend error suggests a progressive problem
with the testing system or control samples, such as deterioration of
reagents or control specimen.
  

Figure 7: Trend
  

The dispersion may indicate instability problems. Fig.8 resents the frequency of
various error conditions.

FIGURE 8: Conceptual basis of control charts.