total quality control, total quality leadership, continuous quality improvement, quality management science, industrial quality management.
it provides both a management process for improvement of quality in all aspects of work.
is defined as conformance to the requirements of users or customers and the satisfication of their needs and expectation
customer focus, management commitment, training, process capabilityy and control, measurement using quality- improvement tools.
occurs when problems are eliminated permanently.
shown that 85% of all problems are process problems, whereas the remaining 15% are problems requirig the action and performance improvement of individual employees.
views the organization as a support structure rather tha a command structure.
elements of a project by project approach to quality improvement
careful definition of the problem, establishment of baseline measures of process performance, identificiation of a remedy for the problem,identification of root causes of the problem, verification that the remedy actually works, standardization or generalization of the solution for routine implementation of an imrpoved process, establishment of ongoing measures for monitoring and control of the process
essentials of quality system
documents and records, organization, personnel, equipment, purchasing and inventory, process control, information management, occurence management, assessmen:external and internal,process improvement, customer service.
total quality management
emphasizes the estalishment of quality laboratory processes (QLPs), quality control,quality assessment, quality improvement, quality planning.
quality laboratory processes
QLP include analytical processes and the general policies, practices, and procedures that define how all aspects of the work are done.
QC emphasizes statistical control procedures, but also includes non-statistical check procedures, such as lineaRITY CHECKS, reagent and standard checks, and temperature monitors.
curently applied, monitors of laboratory performance, such as: turnaround time, specimen identification, patient identification, test utility.
occurs when problems are eliminated permanently.
industrial experience has shown that 85 percent of all problems, 15 percent are problems requiring the action and performance improvement of individual employees.
primarily management problems because only management has the power to change work processes.
necessary to standardize the remedy, establish measures for performance monitoring, ensure that the performance achieved satisfies quality requirements, document the new QLP
Five- Q framework
also defines how quality is managed ojectively with the scientific method, or the PDCA cycle; plan,do,check,act.
basis for objective management decisions
the methodology naturally applied in scientific experiments
total testing process
accurate and timely test reports are the responsibility of the laboratory. however many problems arise before and after submitted specimens are analyzed, therefore the total testing process must be managed properly in the reanalytical, analytical, and postanalytical.
Process; test ordering preanalytical
potnetial errors; inappropriate test, handwriting not legible, wrong patient identification,special requirements not specified, cost ofr delayed order
process; specimen acquisition, preanalytical
incorrect tube or container, incorrect impatient identification, inadequate volume, invalid specimen (e.g hemolyzed or too dilute), collected at wrong time,improper trasport conditions.
instrument not calibrated correctly, specimen mix-up, incorrect volume of specimen, interfering substance present, instrument precision problems
test reporting postanalytical
wrong patient identification, report not posted i chart, report not legible, report delayed, trascription error.
test interpatation postanalytical
interfering substances not reognized, specificity of test not understood, precision limitations not recognized, analytical sensitivity not appropriate, previous values not available for comparison.
control of preanalytical variables
establishing effective methods for the monitoring and control of preanalytical cariables is difficult because many of the variables are outside the traditional laboratory areas.
control of preanalytical variables
monitioring preanalytical variables requires the coordinated effort of many individuals and hospital departments, each of which must recognize the importance of these efforts i the maintenance of high-quality service. there are many variables i the preanalytical process.
variables in the preanalytical process
test usage and practice guidelines, patient identification, turnaround time, laboratory logs, transcription errors, patient preparation,specimen collection, specimen transport,specimen separation and distribution of aliquots.
correct identification of patients and specimens is a major concern for laboratories. the highest frequency of errors occurs with the use of handwritten labels and request forms.
turnaround time (TAT)
the elapsed time from when a test was ordered until the test result is reported is known as the turnaround time for the test delayed ad lost test requisitions, specimens, and reports contribute to unaccpetable TATs. therefore, in practice, it is necessary to record the actual times of; specimen collection, receipt in the laboratory,reporting of test results.
whe the serum aliquot tubes arrive in the laboratory, a request/report form generally accompanies the specimens. the patient name and identification number and the tests requested on the form should be checked against the information on the label of the specimen tube to ensure that they are the same.
in addition, the speimen should be inspected to confirm adequacy of volume and freddom from problems that may interfere with the assay, such as lipemia or hemolysis.
the specimens then should be stored appropriately, and the identification information and arrival time recorde in a master log.
in laboratories where elctronic identification and tracking have not been implemented, a substantial risk of transcription error exists from manual entry of data, even when results are double-checked.
laboratory tests are affected by many patient factors, such as recent intake of food, alcohol, or drugs,and smoking exercise, stress, sleep, posture during specimen collection, and other variables. proper patient preparation is essential to obtain meaniful test results. the laboratory must define the instructions and procedures for patient preparation and specimen acquisation
the techniques used to acruie a specimen affect laboratory tests. improper containers and incorrect preservatives also affect test results and make them inappropriate. one way to monitor and control this aspect of laboratory team to specime collection.
the stability of specimens during transport from the patient to the laboratory is critical for some tests performed locally and for most tests sent to regional centers and commercial laboratories.
to control specimen transport, the essential feature is the authority to reject specimens that arrive in the laboratory in an obviously unsatisfactory condition )such as a thawed specimen that should have remained frozen.
specimen separation and distribution of aliquots
separating blood specimens and distribution of aliquots are function usually performed under the direct control of the laboratory; centrifuges, containers, personnel
control of analytical variables
must be controlled carefully to ensure accurate measurements by analytical methods. reliable analytical methods are obtained through a careful process of: selection evaluation,implementation, maintenance, control.
documentation of analytical protocols
in practice, a process may be documented as a flowchart or table that describes operations within the laboratory.
are concerns with result reporting things done after analytical testing has been done. test reporting has manu parameters to consider such as was the patient fasting or not? was the specimen collected properly?
can make the difference between life and death in some cases.
external quality assessment and proficiency testing programs; two procedures are complementary
internal QC being necessary for the daily monitoring of the precision and accuracy of the analytical method, external QA being important in the maintenance of long-term accuracy of the analytical methods.
proficiency test and CLIA
participation in an external proficiency testing (PT) program is required for all U.S. laboratories that perform tests classified as moderate ad high complexity tests.
current approved providers of proficiency testing programs
deliver sets of up to five specifmens for analysis by the laboratory three times per year.
the laboratory reports its results to the provider
who then makes them avaiable to rhe regulatory agencies.
several external QA programs available to the clinical laboratory
are sponsored by professioal socities and manufacturers of control materials.
the basic operation of these programs involves all the participating laboratories
analyzing the same lot of control material, usually daily as part of the internal QC activities. the results are tabulated monthly and sent to the sponsoring group for data analysis.
summary reports are prepared by the program sponsor ad
distributed to all particapating laboratories.
advances in telecommunications and the accessibility and versatility of the ubiquitous internet
real time external QC is available
reports generated from external QA programs
often include extensive data analysis, statistacal summaries, and plots.
overall means of all laboratories in the program or the mean of values of all laboratories is taken as the
true or correct value and is used for comparison with the individual laboratory's mean
external quality assessment and proficiency testing
process in which simulated patient specimens made from a common pool are analyzed by a laboratory. the results of this procedure are evaluated to determin the quality of the laboratory;s performance.
external quality assessment and proficiency testing
participation in an external proficiency testing (PT) program is reuired for all U.S. laboratories that perform tests classified as moderate and high complexity tests.
proficiency testing and CLIA
CLIA '88 requires all U.S. laboratories to register with the government and to identify the tests they perform. tests are classified as weither waived or nonwaived.
are those that any laboratory can perform as long as they follow the manufacturers directions
there are no other requirements for quality management of those tests
laboratories that perform nonwaived tests are subject to the complete CLIA regulations and must be inspected periodically by the government or by certain professional organizations that are deemed to have standards at least as stringent as the CLIA requirements.
two such organizatons
college of american pathologists (CAP) and the JOINT COMMISSION (JC)
the CLIA implementation rules
and interpretative guidelines outline the criteria for acceptable performance in laboratory inspection and accreditation
the final rules dealt mainlyh with chages to the subpart on QS
with particular attention to preanalytical, analytical, and postanalytical systems.
places increased emphasis on having QS to
monitor preanalytical and postanalytical processes, yet the biggest impact of the final rule is on analytical QA ad analytical QS.
the CLIA '88
proposed criteria that group laboratory tests into specialty and subspecialty categories and specify represetative tests to be monitored in each category.
to succeed in a given category
a laboratory must produce correct results on four or five specimens for each of the analytes in that category and score overall at least 80 percent for three consecutive challenges.
if more than two incorrect result are produced for any analyte,the laboratory is considered
if a laboratory has two or more incorrect results for any analyte or an overall score less than 80 percent on two of three consecutive surveys.and must cease testing all analytes in that specialty category until it is reinstated.
new requirement of the final CLIA regulations
is that laboratories must perform method validation studies on all new tests introduced after april 24, 2003.
with the issuance of the final rules
the performance of all new tests must validated in each laboratory to document the reportable: range,precision, accuracy, reference intervals.
for some methods
it may also be necessary to determine the detection limit and to test for possible interferences.
another major change in the final rule
was the elimination of an earlierprocison that would have required the FDA to review a manufacturer's QC instructions.key provision for allowing laboratories to simply follow a manufacture's directions.
laboratories now have more resposibility fofr establishingeffective QC systems that will:
monitor the complete analytical process, take into account the performance specifications of the method, detect immediate errors,monitor long-term precision and accuracy.
standard operating procedures
standard operating procedure (SOP) IS A PROCEDURE document that provides step-by-step instructions that an individual neeeds to follow to successfullly complete one activity in the process, such a procedure is critical if a method is to provide the sameresults when usedbydifferent analysts over a long period of time. below the information that is contained in a procedure document. the contents needed in a laboratorymanual SOP is listed in a good practice.