CN101303340A

CN101303340A - Method for performing quality control with patient specimen testing result difference value

Info

Publication number: CN101303340A
Application number: CNA2007100348876A
Authority: CN
Inventors: 佘鸥
Original assignee: Hunan Clinical Laboratory Center
Current assignee: Hunan Clinical Laboratory Center
Priority date: 2007-05-08
Filing date: 2007-05-08
Publication date: 2008-11-12

Abstract

The invention discloses a quality control method of the clinical examination field, that is, one detecting systems is taken as a reference standard detecting system (the system is calibrated by matching calibrating articles that can be traced back to the reference method and strictly monitored and controlled everyday by a matching quality control system, and is a detecting system of normative operations in good running status); the specimens of patients are concurrently detected in the reference standard detecting system and the controlled detecting system, and the differences between the results are made into a quality control chart so as to monitor and control the precision and accuracy of the controlled detecting system. The quality control method of the invention is beneficial to sustainable quality improvement of the detecting system and saving medical costs and relieving the pains of patients, and also solves the consistency problem of clinical examination results in laboratory.

Description

A kind of method of carrying out quality control with patient specimen testing result difference value

Technical field

The present invention relates to the method for quality control in a kind of clinical examination field.

Background technology

At present, the method that clinical labororatory carries out daily monitoring to detection system probably has two classes: the first is used the Quality Control thing, and it two is directly to map with the testing result of patient specimen.Testing result directly mapping is subjected to the influence of sampling value fluctuation on the same day bigger, is difficult for observing tendency and changes.Simultaneously, at home, in outer numerous large and medium-sized hospital, the analytical instrument that same laboratory has different brands, different model has become than general phenomenon, cause in same laboratory same sample on different instruments, to be analyzed, the deviation that measured value may occur is given assessment and explanation results and is brought difficulty to relying on the laboratory data dynamic monitoring clinically.

Summary of the invention

Make method that Quality Control figure carries out quality control (detection system is monitored) for the consistance that realizes clinical examination result in the laboratory with save that medical treatment cost reduces patient's burden and the scheme of design is with patient specimen testing result difference value: selects one can trace to the source that (this system carries out the daily monitoring of strictness through supporting caliberator calibration and supporting Quality Control thing as the standard detection system of reference to the detection system of reference method, and the detection system of the standard operation that running status is good), on this and controlled detection system, detect simultaneously with patient specimen then, the difference of testing result is made Quality Control figure, the method that the precision and the accuracy of controlled detection system are monitored.

The method for making of difference Quality Control figure:

1. determining of control limit: 1. writing down difference data every day, calculate the standard deviation (S) of the absolute value of the first two ten difference, is transverse axis with difference 0, serves as the warning line with 0 ± 2S line, and 0 ± 3S line is that line out of control is made Quality Control empty graph (see figure 1).2. after three months, calculating and detected the S of the absolute value of difference as a result in these three months, is transverse axis with difference 0 again, serves as the warning line with 0 ± 2S line, and 0 ± 3S line is that line out of control is made the Quality Control empty graph.Trimestral S makes the Quality Control empty graph of this month before every month later on.

2. draw difference Quality Control figure: with difference data record every day, and on the Quality Control empty graph of this month the described point line, draw the broken line Quality Control figure of difference.

3. criterion out of control: according to difference drop on site on the Quality Control figure according to Westgard more rules control method or Levey-Jennings control method to the standard determination of judgement out of control in control and out of control.

4. calculate mean value (X), standard deviation (S) and the coefficient of variation (CV) of of that month test item per the end of month.

Difference is good more near 0 explanation accuracy more, and the bright precision of novel is high more more for the CV of difference, and is good more with the correlativity of reference standard detection system.Every day, the result was apparent on the Quality Control figure, can carry out monitoring in real time to detection system, also can carry out long-term dynamic observing.

The beneficial effect that the present invention is used in the clinical examination quality control is: the quality improvement that is beneficial to the detection system continuation; Save medical treatment cost and reduce patient's burden; Also solved simultaneously clinical examination result's consistency problem in the laboratory.

Embodiment

1. material

1.1 instrument, equipment and reagent: the 1. semi-automatic blood analyser of Sysmex F-820 type, supporting AD-270 automatic dilutor, DB-1 sample cup and matched reagent, produce by Japanese Sysmex Co., Ltd..2. CD-3700 type automatic blood analyzer and supporting reagent.

1.2 caliberator, Quality Control thing: SCS-1000 caliberator that the semi-automatic blood analyser of Sysmex F-820 type is supporting and Eightcheck-3WP whole blood quality control materials.

1.3 patient's fresh whole blood: select the leucocyte testing result in term of reference, and the EDTA-K of non-blood disease and hepatopathy patients ₂The anti-freezing fresh whole blood.

2. method

2.1 the calibration of instrument: with the SCS-1000 caliberator the semi-automatic blood analyser of Sysmex F-820 type is calibrated, calibration steps is carried out in strict accordance with " the blood analyser calibrating standard " of check branch of Chinese Medical Association hematology, the promulgation of the osology Committee of Experts.

2.2Sysmex the daily Quality Control of F-820 type instrument: on Sysmex F-820, measure definite value Eightcheck-3WP whole blood quality control materials every morning, confirm that in strict accordance with Westgard more rules control method instrument is in control.

2.3CD-3700 the calibration of type instrument: with EDTAP dipotassium ethylene diamine tetraacetate (EDTA-K ₂) getting healthy people's fresh blood 10ml for the vacuum test tube of anti-coagulants, it is 1.5-2.2mg that every ml needs the concentration of anti-coagulants.Calibration steps is reference with the Sysmex F-820 type detection system of standard operation, carries out in strict accordance with " suggestion of blood analyser calibrating standardization ", and the result is traced to the source indirectly to international standard.

Determine 2.4 Quality Control figure controls limit: the fresh blood of 1. getting a patient every day is measured on Sysmex F-820 type and two blood analysers of CD-3700 type simultaneously, and measuring is finished in back 2 hours in blood sampling.Write down the testing result of leucocyte (WBC), and CD-3700 type measured value is subtracted Sysmex F-820 type measured value, difference is that timing is represented CD-3700 type measured value greater than Sysmex F-820 type measured value, otherwise for negative.2. calculating the standard deviation (0.49) of the first two ten absolute difference, is transverse axis with difference 0, serves as the warning line with 0 ± 0.98 line, and 0 ± 1.47 line is the Quality Control empty graph (see figure 2) that line out of control is made WBC.

2.5CD-3700 the daily Quality Control of type instrument: with 2.4 1., the difference of every day is marked at (see figure 3) on the of that month Quality Control empty graph.

2.6 criterion out of control: drop on site on the Quality Control figure according to the criterion out of control of Westgard more rules control method or Levey-Jennings control method according to difference, judge in control and out of control.Every day, the result was apparent on the Quality Control figure, carried out monitoring in real time.

2.7 mean value (X), standard deviation (S) and the coefficient of variation (CV) of of that month WBC difference are calculated in month end.

Accompanying drawing 1 is the empty graph of difference Quality Control figure.Numeral on the horizontal ordinate is measured the date (number of times).Numeral on the ordinate is the difference of measurement result, for just, below is negative more than 0, and ± 1 line is a standard deviation (S) control line, and ± 2 lines are two standard deviations (2S) control line (warning line), and ± 3S line is three standard deviations (3S) control line (line out of control).

Accompanying drawing 2 is Quality Control figure of leucocyte (WBC).Numeral on the horizontal ordinate (1,3 ..., 25) expression measures the date (number of times).Numeral on the ordinate is the difference of measurement result, for just, below be negative more than 0, ± 0.49 line is a standard deviation (S) control line, ± 0.98 line is two standard deviations (2S) control line (warning line), and ± 1.47 lines are three standard deviations (3S) control line (line out of control).

Accompanying drawing 3 is difference broken line Quality Control figure of leucocyte (WBC).

Claims

1, a kind of method of carrying out quality control with patient specimen testing result difference value.It comprises patient's sample, detection system, the difference of testing result, the standard deviation of difference, quality control chart, by the difference with patient's detection result of specimen controlled detection system is carried out the purpose that daily monitoring reaches quality control.It is characterized in that clinical examination quantitative measurement project carries out quality control with the difference of patient specimen measurement result.

2,, it is characterized in that with a detection system to reference method of can tracing to the source as the reference detection system, another is controlled detection system according to the described difference method of quality control of claim 1.

3,, it is characterized in that utilizing the difference making difference Quality Control figure of patient specimen measurement result that controlled detection system is monitored according to the described difference method of quality control of claim 1.

4, according to claim 3, it is characterized in that drawing broken line Quality Control figure according to difference.

5,, it is characterized in that utilizing the standard deviation of the difference of patient specimen measurement result to formulate the control limit according to the described difference method of quality control of claim 1.

6, according to the described difference method of quality control of claim 1, it is characterized in that clinical examination detection by quantitative system.