S.LESSON%207

QUALITY MANAGEMENT
Quality Management of Preanalytical Processes

Even the most accurate measurement using the most up to date technology by a highly
trained technologist may cause an untoward clinical outcome if the wrong test is ordered or the
specimen is compromised prior to analysis. The preanalytical phase of the testing cycle is
complex and is prone to the most variation and the highest proportion of errors.
Preanalytical Process
A. Test selection and ordering
- The first step int the testing process occurs at the moment of test selection. While the
majority of laboratory testing is ordered by physicians and nurse clinicians, other
groups including pharmacists on some jurisdiction, can order tests.
- Information on laboratory testing is expansive and involves knowledge of the
indications for testing, including test sensitivity and specificity for the patient’s
condition or diagnosis
- Preanalytical errors associated with ordering tests include inaccuracies or omissions
when transcribing from paper requisitions into a laboratory computer system, tests
performed but not actually ordered associating the order with the wrong physician,
and mistakes with assigning priority status to the order
- The most common error associated with ordering test was assignment of the wrong
physician with an order, and the least common was test priority assignment. High
test volume, verbal orders and lack of laboratory policies and procedure ensures a
high-quality order entry process were associated with higher error rates.
B. Quality of specimen collection
- Laboratory test results may be affected by the patient’s condition at the time of
specimen collection, as well as by the materials and procedures used for specimen
collection.
- Special attention must be given to the collection of specimens for microbiological
examinations. Poor-quality specimens that are collected improperly or
inappropriately will produce useless or even misleading results that may be
misinterpreted as having significance to patient care. In some cases, specimen
quality can be evaluated by smear examinations before cultures are performed, and
specimens may be deferred form testing if judged to be of poor quality.
C. Patient and client satisfaction
- Typically, the only direct experience patients have with the laboratory is during
phlebotomy. Patient satisfaction with this experience is an important preanalytical
quality measurement.
- Laboratories should also conduct nurse and physician satisfaction surveys
D. Specimen transport, storage, receipts, and preanalytical processing
- Specimens can deteriorate through prolonged delays or failure to maintain proper
conditions during transport.
- Specifications for specimen transport and storage based on stability of ab\analytes
should be validated and documented.
- Accurate identification of the specimen throughout the testing process is vital
Quality Management of Analytical Processes
Quality management of the analytical phase involves reducing inaccuracy and
imprecision of test methods as much as possible. Attention to standardizing test procedures and
monitoring method performance with a well-designed quality control system are the key
elements for meeting this management goal. Appropriate method selection and proper training
are additional factors that are important for success.
A. Method selection and evaluation
- Method selection is laboratory dependent and based on characteristics that best fit
internal goals for cost, timeliness and reliability.
- The complexity of analysis including calibration, stability of reagents and controls,
sensitivity and specificity of the method, linear range of analysis, and interferences,
as well as types of internal and external proficiency systems, are factors that may
affect method selection decisions.
- Method evaluation and implementation involves assessing the analytical process
statistically by the use of control materials, establishing or validating the reference
range of the population being tested, documenting the procedure in writing, and
training personnel.
- When a new method is introduced, it must be compared to the old method before
bringing it into use.
Method evaluation and implementation
Stage 1
Prepare and document procedure
Validate linearity and calibration
Determine within-run imprecision
Evaluate for interferences
Stage 2
Determine between-day imprecision
Compare to old method
Evaluate acceptability of impression and bias
Perform or validate reference ranges
Stage 3
Establish final quality control ranges, critical values, and delta checks
Train personnel
Complete and sign procedure documents
Notify clients of any significant changes in method
B. Quality control
- The term “quality control’ describes the approach used to monitor the analytical
process to ensure that the test results meet their quality requirements.
- Quality control includes establishing specifications for the analytical process,
monitoring the analytical process to determine conformance to these specifications,
and taking any necessary corrective actions to bring the analytical process into
conformance
The primary quality characteristics that is monitored during the analytical process is the
deviation of an analytical measurement from expected
C. Quality control rules
Common quality control rules
1-2 SD: use as a rejection or warning when one control observation exceeds the
control limits; usually used as a warning
1-3SD: reject a run when one control observation exceeds the control limits.
Detects random error and large systematic error.
1-3.5SD: reject a run when one control observation exceeds the control limits.
Detects large random and systematic error. Use only with highly precise assays.
1-4SD: reject a run when one control observation exceeds the control limits.
Detects large random and systematic error. Use only with highly precise assays
2-2SD: reject a run when two consecutive control observations are on the same
side of the mean and exceed the control limits. Detects systematic error.
4-1SD: reject a run when 4 consecutive control observations are on the same
side of the mean and exceed either the control limits. Detects small systematic
error, very few applications.
10X: rejects a run when10 consecutive control observations are on the same
side of the mean. Detects very small errors; do not use.
R-4SD: reject a run if the range or difference between the maximum and
minimum control observation out of the last 4-6 control observations exceeds
4SD. Detects random errors; use within run.
x-0.01: reject a run if the mean of the last N control observation exceeds the
control limits that give a 1% frequency of false rejection (pfr=0.01).
R-0.01: Reject a run if the range of the last N control observations exceeds the
control limit that give a 1% frequency of false rejection (pfr= 0.01)
D. Use of patient data for quality control
Limit Check
- Repeated testing in the most timely manner if the initial results were “critical.”
- This kind of a check delays the reporting of the critical value to the caregiver.
Patient-sample comparisons
- These comparisons require the regular analysis of split samples on identical or
dissimilar instruments that measure the same analyte. Differences between
instruments that exceed predetermined limits are investigated and corrected
Average of patient (AOP)
- In AOP, an error condition is signaled when the average consecutive centrally
distributed patient data is beyond the control limits established for the average of the
patient data.
- The assumption underlying AOP is that the patient population is stable. Any shift
would this be secondary to an analytical shift
Delta Check
- A rule-based method to compare a patient’s current test result to a previous
measurement to check for unexpected differences that might be dure to analytical or
nonanalytical error in the testing process.
E. External quality control (proficiency testing) or EQAS
- Proficiency-testing programs provide samples of unknown concentrations of analytes
to participating laboratories.
- Their purpose is to evaluate the ability of laboratory personnel to achieve the correct
analysis.
- Participation in these programs is usually government-mandated, with the premise
that acceptable performance indicates proficiency in patient specimen analysis. this
assumes that proficiency specimens are comparable to and treated the same as
patient specimens.
Quality Management of Postanalytical Process
The 2 most important factors affecting the postanalytical phase of the testing
process are test reporting and result interpretation. Procedures for defining and reporting
critical laboratory test results must be developed and periodically reviewed by the
laboratory director in conjunction with the medical staff to ensure that clinicians are
immediately notified about abnormal results when necessary.
Quality management of result utilization and proper test interpretation is

underdeveloped at this time. For example, the appropriateness and timeliness of
treatment of patients with serious infections improve when the laboratory actively
broadcasts the finding of clinically significant bacterial culture results.
Turn around time
- Excessively prolonged laboratory test turnaround time is one of the most common
complaints voiced to the laboratory manager.
- The slow delivery of laboratory results is associated with increased diagnostic
uncertainty and delays in patient management.
- From an outcome perspective, slow test turnaround times lead to longer waiting
times for the patient or incomplete information at the time of a clinical encounter.

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QUALITY MANAGEMENT

Quality Management of Preanalytical Processes

D. Use of patient data for quality control

Quality management of result utilization and proper test interpretation is

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