QUALITY MANAGEMENT IN CLINICAL BIOCHEMISTRY  

Tapeshwar Yadav(Lecturer)BMLT, DNHE,

M.Sc. Medical Biochemistry

QUALITY Conformance to the requirements of users or customers satisfaction of their needs and expectations.

Total Quality ManagementA management approach that focuses on processes and their improvement.

FIVE ‘Q’ Framework

Quality Planning

Quality Lab Processes

Quality ControlQuality Assessment

Quality Improvement GoalsObjectivesQuality Requirements

‘PDCA’ CYCLE  PLAN DO CHECK ACT  QP - PROVIDES THE PLANNING STEP  QLP - ESTABLISHES STANDARD PROCESS FOR DOING

THINGS  QC AND - PROVIDES MEASURES FOR QA CHECKING , HOW WELL THINGS ARE DONE   QI - PROVIDES MECHANISAM FOR ACTING ON THESE

MEASURES

QUALITY ASSURANCE REQUIRES

1. CAUSES OF PROBLEMS BE IDENTIFIED AND ELIMINATED

 2. DETECTION OF THE PROBLEMS

EARLY ENOUGH TO PREVENT THEIR CONSEQUENCES

ELEMENTS OF QUALITY ASSURANCE

1. COMMITMENT

Dedication to quality service must be central. A true commitment is required by Lab Directors,Managers and Supervisors if the efforts of the lab personnel are to be successful.

2.FACILITIES AND RESOURCESLab must have the administrative support necessary to provide the quality of services that is desired. This means having , adequate space, equipment, materials, supplies, staffing, supervision and budgetary Resources.These resources provide the basis upon which quality services can be developed and maintained.

3. TECHNICAL COMPETENCE

High quality personnel are essential for high quality services. The educational background and experience are important. In service training can develop and maintain skills.

4. TECHNICAL PROCEDURESGood technical procedures are necessary Control of preanalytical conditions or variables such as Test requests

Patient preparationPatient identificationSpecimen acquisitionSpecimen transportSpecimen processingSpecimen distributionPreparation of work lists and logsMaintenance of records

Control of analytical variables, which includes  Analytical methodology

Standardization and calibration proceduresDocumentation of analytical protocols and

proceduresMonitoring of critical equipment and materials

  Monitoring of analytical quantity by the use of statistical methods and control charts. 

CONTROL OF PREANALYTICAL VARIABLES

The responsibility for accurate and timely test reports generally lies with the laboratory but many problems can arise prior to and after the analysis of the submitted specimens.

 So it is essential to perform a system analysis of the laboratory and to identify the type of preanalytical variables.

LABORATORY TESTING PROCESSES AND THEIR POTENTIAL ERRORS  PRE ANALYTICAL ERRORS

 PROCESS POTENTIAL ERRORS Test ordering inappropriate test

Handwriting not legibleWrong patients IDSpecial requirements not specified

 Specimen acquisitionIncorrect tube or containerIncorrect patient IDInadequate volumeInvalid specimen (hemolysed or diluted) Collected at wrong timeImproper transport conditions

ANALYTICAL ERRORS

 Analytical Instrument not calibrated Measurement correctly

Specimens mix – upIncorrect volume of specimenInterfering substances presentInstrument precision problem

Test reporting Wrong patient IDReport not legibleReport delayedTranscription error

POST ANALYTICAL ERRORS Test interpretation Interfering substance not recognized

Specificity of the test not understoodPrecision limitation not recognizedAnalytical sensitivity not appropriate

Previous values not available for comparison

HOW TO CONTROL THESE ERRORS? PRE ANALYTICAL VARIABLES  It is very difficult to establish effective methods for monitoring and controlling

preanalytical variables because many of the variables are outside the laboratory areas.

  Requires the coordinated effort of many individuals and hospital departments Patient Identification   The highest frequency of errors occurs with the use of handwritten labels and

request forms. The use of bar code technology has significantly reduced ID problems.

Turnaround timeDelayed and lost test requisitions, specimens and reports can be major problems for labs. Recording of the actual times of specimen collection, receipt in the lab and reporting of results with use of computers will solve these problems.

Transcription error  A substantial risk of transcription error exists from manual entry of data even

with the double checking of results, computerization will reduce this type of transcription error.

 Patient preparation Lab tests are affected by many factors, such as, recent intake of food, alcohol, or drugs smokingexercisestresssleepposture during specimen collection The lab must define the instructions and procedures compliance with these instructions can be monitored directly efforts should be made to correct non compliance

Specimen Collection  Prolonged tourniquet application causes local anoxia to cells and excessive venous

backpressure, venous stasis and hemoconcentration.   Blood collection from an arm into which an intravenous infusion is running can be diluted or

contaminated. Hemolysis during blood collection

Improper containers with incorrect preservatives

  To monitor and control these problems, specially trained lab team assigned to specimen collectionThe identification of the person collection a specimen should be maintained  Clinicians should be encouraged to report clinically inconsistent results.Pride of workmanship should be encouraged and quality performance should be rewarded.

 Specimen transport

The stability of specimens during transport from the patient to the lab is seldom monitored;

CONTROL OF ANALYTICAL VARIABLES

There are many analytical variables that must be carefully controlled –

Water qualityCalibration of analytical balancesCalibration of volumetric glassware and pipetsStability of electrical powerStability of temperature of heating baths,

refrigerators, freezers and centrifuges

The procedure Manual should contain the following

Procedure nameClinical significancePrinciple of methodSpecimen of choiceReagents and equipmentsProcedureReference valuesCommentsReferences

CONTROL OF THE ANALYTICAL QUALITY USING STABLE CONTROL MATERIALS

The performance of analytical methods can be monitored by analyzing specimens whose concentrations are known and then by comparing the observed values with known values.The known values are usually represented by an interval of acceptable values, or upper and lower limits for control (control limits)When the observed values fall within the control limits – analysis is working properlyWhen the observed value fall outside the control limits the analyst should be alerted to the possibility of problems in the analysis.

GENERAL PRINCIPLES OF CONTROL CHARTS  

Control charts are simple graphical displays in which the observed values are plotted versus the time when the observations are made.

 The control limits are calculated from the mean (x) and standard deviations (s)

SD

• Standard deviation - extent of random variation

• SD = d2

n-1

d= difference of individual result from meann= number of observations

CVCo-efficient of variation relative magnitude of variability while comparing two procedures

CV % = (SD x 100)/mean

Precision: Refers to the reproducibility of the result. Indicates how close test measurements are to

each other when the same test is run on the same sample repeatedly.

Accuracy: Indicates how close to the true value a

measurement is. The closer it is to the actual value the more

accurate.

ACCURACY AND PRECISION

Good Accuracy Good Precision

Good Precision

Only

Neither Good precision Nor Accuracy

Levey-Jennings Control Chart

External quality assessment :A quality program in which specimens are submitted to labs for analysis and the results of an individual lab are compared with the results for the group of participating labs.

Proficiency Testing:Process whereby simulated patient specimens made from a common pool are analyzed by labs the results of this procedure being evaluated to determine the quality of the lab performance.