医疗机构血糖仪操作规范（Operation specification for blood glucose meter in medical institutions）

医疗机构血糖仪操作规范（Operation specification for blood glucose meter in medical institutions） 医疗机构血糖仪操作规范(Operation specification for blood glucose meter in medical institutions) "Medical institutions and the management of portable blood glucose meter The clinical operation specification (Trial) "notice Health bureaus of all provinces, autonomous regions and municipalities directly under the central government, the Health Bureau of Xinjiang production and construction corps: Specification for clinical use of portable blood glucose meter, blood glucose test standard clinical behavior, medical institutions to improve blood glucose detecting quality and level, guarantee medical quality and safety, the Ministry of transport formulated the "medical institutions of portable blood glucose meter and clinical management practices (Trial)", is issued to you, please refer to. Two December 30th 2010 (information disclosure form: active open) The medical institutions and the management of portable blood glucose meter The clinical operation specification (Trial) In order to strengthen the medical institutions at all levels of the portable blood glucose meter (hereinafter referred to as the blood glucose meter) clinical management, standardize clinical blood glucose testing, security testing quality and medical safety, according to the "Office of the Ministry of health on strengthening the administration of the use of the notice of the portable blood glucose meter" (Public Health Office of medical clinical FA 2009 No. 126), "on the norms of medical institutions for clinical use of portable blood glucose meter, blood sampling pen notice" (Wei Yifa 2008 No. 54) and People's Republic of China health industry standard "portable blood glucose meter, blood glucose testing guide" (WS /T 226-2002) and other documents required to develop this specification. This code is applicable to all kinds of medical institutions to use various types of portable blood glucose meter non diagnostic blood glucose monitoring. A blood glucose meter and medical institutions management. Blood glucose meter is real-time test (Point-of-care testing, POCT, also known as test bed equipment). The management should be part of the POCT management of medical institutions. (a) to establish and improve the clinical use of blood glucose meter management regulations. Medical institutions shall prepare and conscientiously implement this mechanism of blood glucose meter management procedures. Procedures should include the following contents: 1. sample collection procedures. The detailed steps include the correct specimen collection and measures to prevent cross infection. 2. blood glucose testing procedures. 3. quality control procedures. Record and report the quality control method for blood glucose and complete the test results. 4. test results of the report issued by the rules. The blood glucose test results are too high or too low, should put forward corresponding proposal. 5. waste disposal procedures. Processing method of waste used for blood collection, strip, etc. the sterilized cotton ball. 6. storage and maintenance procedures. (two) the evaluation and selection of appropriate test and blood glucose meter and corresponding device, and record management of all institutions in the use of blood glucose meter. (three) regularly organize medical personnel training and assessment, and records of training and examination results of the training and assessment of qualified personnel can be engaged in the operation of clinical blood glucose meter. The training content should include: blood glucose testing application value and its limitation, blood glucose meter detection principle, applicable scope and characteristics, instrument, test strip and the quality control of the storage conditions, specimen collection, blood glucose testing procedures, quality control and quality assurance, how to interpret the blood glucose test results, blood glucose test results of the error sources, safety preventive measures. (four) a blood glucose meter detection quality assurance system, including the system of internal quality control and perfect quality assessment. Comparison and evaluation of test results the test results of 1. blood glucose meter and biochemical mechanism method, every 6 months and not less than 1 times. 2. per meter should have the quality control records should include the test date, time, instrument calibration, strip batch number and validity, instrument number and quality control results. The management personnel shall regularly check the quality control record. The 3. day blood glucose test before each instrument shall be advanced for quality control testing. When the replacement of the new batch test strip, blood glucose meter, battery replacement or instrument and strip may not be in the best state, should be re tested additional quality control products. Each meter should have the corresponding concentration of glucose control, Usually include high and low concentration of two. 4. out of control analysis and processing: if the quality control result is not beyond the range of blood glucose were determined. Out of control should find out and correct, re quality determination, to obtain correct results. 5. medical institutions by blood glucose meter blood glucose testing shall participate in the blood glucose testing room quality assessment. Two, the choice of blood glucose meter (a) must conform to the national standard blood glucose meter, and approved by the State Food and Drug Administration registration clinical application of admission blood glucose meter. (two) blood glucose meter in the same medical unit shall in principle the same type selection, avoid detection results bring different blood glucose meter deviation. (three) accuracy requirements. The reference method for the detection and laboratory detection results of blood glucose meter error shall satisfy the following conditions: 1. when the blood glucose concentration is less than 4.2mmol/L, the detection results of at least 95% of the error in the range of 0.83mmol/L; 2. when the blood glucose concentration greater than or equal to 4.2mmol/L, the detection results of at least 95% of the error was within the range of 20%; 3.100% data acceptable in the clinical area (Annex 1). (four) accuracy requirements. Different date of the standard deviation of the measurement results (SD) shall not exceed 0.42% mmol/L (quality control liquid glucose concentration <5.5mmol/L) and coefficient of variation (CV%) shall not exceed 7.5% (control liquid glucose concentration > 5.5mmol/L). (five) the operation is simple, easily recognizable icons, numerical legible. Should the blood glucose meter values for plasma calibration. The unit should be locked in the international unit of "mmol/L". (six) the linear range of blood glucose testing of at least 1.1-27.7mmol/L, lower or higher than the detection range shall be specified. (seven) the scope of the product of red blood cell pressure of at least 30%-60% or automatically according to the hematocrit adjustment. (eight) peripheral capillary blood glucose meter is suitable for the detection of all. But the vein, artery and neonatal blood glucose detection, should be selected for the corresponding blood glucose meter. (nine) blood glucose meter should be equipped with disposable blood is blood, strips should be used outside of blood, to avoid cross infection. (ten) the different blood glucose meter working principle influenced by different common chemicals. Should choose the appropriate blood glucose meter according to the actual application. Common interference for temperature, humidity, altitude, and acetaminophen, vitamin C, salicylic acid, bilirubin, uric acid, triglyceride, oxygen, maltose, xylose and other substances (Annex 2). Three, the operation process of blood glucose detection (a) test preparation. 1. check the test strip and the quality control of storage is appropriate. The validity and barcode strip with 2. check. 3. clean blood glucose meter. The validity period of 4. inspection quality control. (two) blood glucose detection. 1. with 75% alcohol wipe blood sampling sites, to be dry after the skin puncture. 2. sampling site is usually used on both sides of the fingertips, heel and other peripheral capillary blood, edema or site of infection were not. 3. skin puncture after discarding the first drop of blood, second blood test in the designated area. 4. instruments and operating procedures in strict accordance with the manufacturer's operating instructions requirements (SOP) were detected. The determination results of 5. subjects including record name, date, time, and the determination unit, detection signature etc.. The following measures should be taken to 6. results: abnormal blood glucose when a repeat; inform the doctor to take a different intervention; if necessary intravenous biochemical blood glucose. Four main factors, affect the detection results of blood glucose meter (a) blood glucose meter is capillary blood glucose, and laboratory testing is glucose intravenous serum or plasma, blood glucose meter detection using numerical numerical and laboratory calibration of the fasting plasma is close to that of postprandial or postprandial capillary blood glucose may be slightly higher than in venous blood glucose, blood glucose meter detection with numerical calibration when fasting blood a numerical laboratory is about 12% lower, After a meal or postprandial capillary blood glucose and venous plasma glucose is close to. (two) the peripheral arteriovenous capillary is the junction of both venous blood components, there are blood components, so the blood glucose content and oxygen content and the venous blood is different. (three) the blood glucose meter with blood mostly blood, so the red blood cell pressure affected area, the same level of plasma glucose, with the increase of hematocrit, blood glucose detection value will be gradually reduced. If there is a blood glucose meter hematocrit correction can make a difference to a minimum. (four) biological enzyme method was used to determine the current clinical use of blood glucose meter technology, mainly glucose oxidase (GOD) and glucose dehydrogenase (GDH) two, and GDH is associated with the different coenzyme, respectively pyrroloquinoline quinone glucose dehydrogenase (PQQ-GDH), Huang Suxian (FAD-GDH) adenine dinucleotide glucose dehydrogenase and nicotinamide adenine dinucleotide glucose dehydrogenase (NAD-GDH) three. Different enzymes have different blood glucose meter should adapt to the crowd, choose different enzyme technology according to different conditions of patients. GOD blood glucose meter to glucose high specificity, no other carbohydrate interference, but are vulnerable to disturbance of oxygen. In the aerobic GDH blood glucose meter, without disturbance of oxygen. FAD-GDH and NAD-GDH blood glucose meter cannot distinguish the principle of xylose and glucose, PQQ-GDH blood glucose meter cannot distinguish the principle of maltose, galactose, carbohydrate and glucose, the blood glucose meter Mut.Q-GDH mutation improved the principle of maltose, xylose and other sugars interference. (five) the interference of endogenous and exogenous drugs, such as common interferents paracetamol, salicylic acid, vitamin C, bilirubin, uric acid, triglyceride, oxygen, maltose, xylose etc.. When there are a large number of distractors in the blood, blood glucose value will have a certain deviation. (six) pH value, temperature, humidity and altitude are likely detection results of blood glucose meter impact. Annex: biochemical method comparison 1. blood glucose meter and laboratory 2. kinds of principle of blood glucose meter is susceptible to interference substances Annex 1 Methods the comparison of blood glucose meter and biochemical laboratory program Methods according to the conditions of using one of the following regimens, was 50 cases. The number of samples The glucose concentration range (mmol/L) Two < 2.8 Eight More than 2.8 and less than 4.2 Ten More than 4.2 and less than 6.7 Fifteen More than 6.7 and less than 11.1 Eight More than 11.1 and less than 16.6 Five More than 16.6 and less than 22.2 Five More than 22.2 A comparison test of blood. The use of venous blood samples, gently reversed, the mixing, and the venous blood oxygen partial pressure of P (O2) is adjusted to 8.67 kPa + 0.67kPa (65mmHg + 5mmHg), take proper amount of whole blood for blood glucose meter detection, the remaining 15 minutes of centrifugal separation of plasma, 4 C preservation, 30 minutes laboratory reference plasma glucose test analyzer. The difference between the results of each vein plasma glucose meter test results of venous blood or provided by the manufacturer's conversion formula obtained with the reference analyzer test results is the deviation of the venous plasma. Samples of blood glucose concentration in the range of 2.8mmol/L-22.2mmol/L should be given by the original venous blood samples. Can be adjusted according to the following method of blood glucose concentration in the sample, the limit concentration of samples obtained at both ends: venous blood samples were collected with appropriate anticoagulant in the tube, the temperature in the incubation the blood sugar glycolysis, you can get the blood glucose concentration was less than 2. 8mmol/L samples. Get the system requirements of the sample need incubation conditions (such as temperature) shall be determined by the manufacturer. The venous blood samples were collected with appropriate anticoagulant in the tube, and then add the appropriate glucose, 22.2mmol/L blood glucose concentration samples can be obtained. Scheme two: Test of capillary blood and venous blood ratio. The fasting state, the first finger of peripheral blood by blood glucose meter method according to manufacturer instructions for testing. Then take immediate phlebotomize, Anticoagulation, within 15 minutes of centrifugal separation of plasma, 4 C preservation, 30 minutes by the laboratory reference analyzer blood glucose test. The difference between the peripheral venous plasma glucose results of each blood glucose meter test provided by the manufacturer or the conversion formula and reference analyzer test results is the deviation of the venous plasma. Note: 1. when necessary, in order to ensure the completion of inspection, the need for second skin prick blood. Blood samples available laboratory blood samples from 2. ends of the limiting concentration of alternative methods according to a plan. Annex 2 The principle of all kinds of blood glucose meter is susceptible to interference substances Interfering substances Blood glucose meter enzyme classification oxygen carbohydrate Malt dust xylose Galactose GOD + - - - NAD-GDH - - + - FAD-GDH - - + - PQQ-GDH - + + + Mut.Q-GDH - - - + Note: the "+" denotes interference, "-" said no interference. GOD: glucose oxidase; NAD-GDH: nicotinamide adenine dinucleotide glucose dehydrogenase; FAD-GDH: flavin adenine dinucleotide glucose dehydrogenase; PQQ-GDH: pyrroloquinoline quinone glucose dehydrogenase; Mut.Q-GDH: improved without interference of pyrroloquinoline quinone maltose glucose dehydrogenase.