QUALITY CONTROL MANAGEMENT Quality control is the sum of all those activities in which the laboratory is engaged to ensure

e that the information generated is correct. It includes all aspects of lab activities that affect results such as the choice of methods, education or personnel, handling of specimen and reporting of results Quality control programs vary with the product, available expertise, and the limitation of resources. In he case of hospital laboratories, the product is test data; standards of quality include timeliness of performance, accuracy of results, and effectiveness of communication. Establishing and maintaining of good program may sound expensive, but it pays off in terms of efficiency, higher staff morale and productivity and greater patient acceptance

* Numbers 1 & 2 are more emphasized because the information must be timely to be useful Control of tests Selection of tests should be based on four factors: 1. The result produced should be useful in a timereference frame. 2. The procedure should be feasible for the particular laboratory. 3. The value produced should be accepted to clinicians 4. The reports forwarded to clinicians should be uniform. A good report should be compact, consistent in terminology and format. The assessment factors for method evaluation and selection 1. Precision maybe defined as the extent to which measurements are repeated. The assessment is made by replicate analysis of a biological control containing stable and measurable amounts of the appropriate constituents(s) and expressed as the magnitude of error in the method. 2. Accuracy maybe defined as the extent to which measurement approach the true quantity of the constituent being analyzed. Measurement must be conducted on a reference material having a known composition and concentration. 3. Sensitivity maybe defined as either - the extent to which the minimum amount of constituent can be measured of - the reliability of a test to be positive in the presence of the disease it was design to detect 4. Specificity - maybe defined as either

Division of lab practices on quality control Lab practices on quality control can be divided into 3 major divisions: 1. Preventive are those activities done prior to the examination of specimen or sample and are intended to establish systems conducive to accuracy in analytic systems such as preventive maintenance and calibration of instruments, testing of media, orientation and training of personnel. 2. Assessment are those activities done during the testing to determine whether the test systems are performing correctly such as the use of standards and controls and maintenance of control charts. 3. Corrective are those activities done when error or possible error is detected to correct the system such as equipment trouble shooting, recalibration of instruments, etc. 4DMT 2012

- the extent to which measurements are those of single constituent or - the reliability of a test to be negative in the absence of a disease it was design to detect.

periodically verified to be without contamination or deterioration. 6. In the microbiology laboratory and blood bank where testing is largely the identification of unknowns (qualitative), frequent assessment of reagents and material quality provide the only means of assuring reliable test results. 7. In the clinical chemistry and hematology laboratories, where testing is largely quantitative of specifically requested constituents, biological controls containing the same constituents provide an alternative one step-method for assuring total integrity of test performance.

Control of specimen Collection of proper specimens is extremely important. Those involved in blood collection know the proper way to collect a specimen and the correct details concerning name of tests, containers and labels, time delivery, preparation of patients, preservation or anticoagulant, handling or storage of specimen before delivery to lab and special instruction. A good way to assure proper specimen is the distribution of specimen collection manual to those involved in collection. Control of reagents and supplies Reagent should be purchased only from reliable suppliers. But only the quantity you use in a reasonable time, date it upon receipt and again when opened for use. Guidelines in the use of reagent kits: 1. It should give consistent results from day to day and in patient samples with low, normal and elevated values. 2. The manufacturers data must be complete: statement of principle, description or test performance and calculation, data on precision, accuracy and stability of reagents. 3. Cheaper than manual methods 4. Every employee should be competent to use the kit. 5. The reliability of reagents and materials can never be taken for granted, and they must 4DMT 2012

Control of equipments There is usually some variation in the performance of equipment. The error can be exaggerated if the equipment is improperly calibrated of malfunctioning. Suggestions in the control of equipment: 1. Use National Bureau of Standard equivalent thermometers for monitoring water baths, heating blocks, incubators, refrigerators and similar equipment. 2. Verify the reliability of analytical balances and weights by inspection using National Bureau of Standards class S weights. 3. Verify the speed of centrifuges regularly using quality tachometer. 4. Check all water used in testing for its pH, purity and any foreign substance that could affect test results.

Control of staff The work of any laboratory can be as good as the quality of its workers. Therefore, the laboratory should seek to attract and keep only the best employees. Three important ingredients are: 1. Maintaining an atmosphere of professional challenge 2. Offering fair wages 3. Providing a means for obtaining continuing education * To be sure the staff is working at maximum efficiency- neither underutilized nor overworked a system of workload reporting is necessary

3. Worksheets they are used most commonly for recording test results and other informative data not usually reported. They are particularly well suited to most hospital chemistry and hematology laboratories.

4. Patient identification the customary practice is to attach identification band to all patients. The exact matching of all patient information appearing on the request with that on the bracelet should be done. 5. Distribution of test results in most instances, the recipients of the laboratory data include: a. nursing station personnel (patient chart attachment) b. hospital business office (patient bills) c. attending physician (personnel use) d. laboratory clerical section (department record) 6. Specimen reassignments reassigning specimens to a reference laboratory is considered only after the capabilities and cost of in-house performance are determined. Factors to be considered in the selection of reference laboratories: 6.a. range of available services (brochure listing) b. quality (staff, facilities, etc) c. location (transportation mode) d. turn-around-time (periodic review) e. fee schedule (comparison with laboratories of comparable structure)

Non-analytical quality control functions 1. Physician request all requests made by the attending physician should be stated clearly. 2. Request specification a. time specifications: - routine response for test requests within 24 hours, but may take longer for some procedures as culture - today response and test results within 8 hours - stat response within 10 min, no delay in test performance - specific time specimen collection within +/-5 min time designated, no delay in test performance b. condition specifications: pre-op, preadmissions, etc. c. patient category specifications: in-patient, out-patient etc.

Quality control charts

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Control charts assist in monitoring avoidable and unavoidable error. The usual format includes an ordinate for entering the range of values over which the control results are most likely to occur and abscissa for recording the time intervals at which the control results are obtained. A pair of horizontal lines are included to correspond with the permitted limits (values) of unavoidable error Quality control charts are used in: 1. Identifying the sporadic errors that are generally caused by the analyst control values falling out of acceptable range are rejected as avoidable errors that must be identified and corrected. All unknown tests belonging to this batch are repeated. In the absence of avoidable error, 95% of analysis should be within control values. 2. Determining subtle problems manifested by trends and shifts a trend occurs when control values continue to increase or decrease over consecutive days, suggesting reagent or equipment alterations. A shift is formed by control values that maintain a constant level on one side of the mean line, suggesting an incorrectly prepared reagent. Proficiency testing The major thrust or proficiency testing is to improve the quality of laboratory services by setting forth standards of performance that must be met or exceeded. A reference laboratory is one of the recognized competence, which examines in detail proficiency testing samples or other materials to authenticate identification, content or titer. The laboratory is specially qualified by experience, interest and accepted expertise. The analysis are done carefully and are performed in replicate.

The mean test results values are considered to approach true values and serve as a measurement of the accuracy of test results obtained by the participating laboratories. A referee laboratory is one recognized competence and a general participant in the proficiency program. It uses the same time schedule and performs the examination under the same condition as all other general participants. The identity of these laboratories is not revealed. Their test results are used as a measure of quality of the proficiency testing specimen and with the reference laboratories results, are influencing factors in deciding the acceptable range of results. A participating laboratory is enrolled in a proficiency program and adheres to testing all proficiency specimens in the identical manner employed for patient testing. Replicate analysis are avoided and duplicate assays are performed only when duplicate testing is a laboratory routine. Requirements for participation, frequency of specimen shipments, time allotted for returning results and methods of grading are determined by the organization conducting the program.

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