Dr Piyush Tailor

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**Selection of internal quality control material**
  *Purchase internal quality control material from commercial sources with following quality  
    *Select quality control materials that react to the examining system in a manner as close as possible to patient samples. 
    *chooses concentrations of control materials, wherever possible, especially at or near clinical decision values, which ensure the validity of decisions made.
    *Use independent third party control materials , either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.
    *The sera should preferably from human source.
    *Ready to use sera, not requiring reconstitution, is preferred if composition of sera is not drastically altered (e.g adding preservatives in substantial amount) and freezing chain is maintained from day of production to day of use.
  *Find daily requirement of QC sera in ml.
  *Purchase QC sera in single lot, sufficient to last for 6 months (preferably one year).
  *If internal quality control material from commercial sources is not available, prepare laboratory pool from normal and abnormal samples. 
  *[[calibrator_and_qc|Currently selected reference material information]]  
  *[[Current Calibration Frequency, IQC and EQC policy]]

=====Examination of internal quality control material=====
  *[[Method of washing cups for QC and calibrators]]
===Preparation of quality control sample(Randox)===
  - QC material will be reconstituted by gravimetric method by using Schimatzu weighing machime.
  - Open the QC bottle carefully not to spill any content from bottle
  - keep bottle inside schimatzu and deduct weight of bottle.
  - Now take 1ml pipette and add QC water in bottle carefully gradually till 5gm
  - Mix it by gentle inversion and eversion.   
  - Put it at room temperature for 30 minute and watch for all powder particle has been dissolved.
  - Fill 10 ependroff cup of 500 microliter.and seal it with  parafilm.
===Preparation of quality control sample(VITROS3600)===
  - QC material will be reconstituted by gravimetric method by using Schimatzu weighing machime.
  - Open the QC bottle carefully not to spill any content from bottle
  - keep bottle inside schimatzu and deduct weight of bottle.
  - Now take 1ml pipette and add QC water in bottle carefully gradually till 5gm
  - Mix it by gentle inversion and eversion.   
  - Put it at room temperature for 30 minute and watch for all powder particle has been dissolved.
  - Fill 10 ependroff cup of 500 microliter.and seal it with  parafilm.

===Preparation of quality control samples for lipase===
  - Make low and high lipase serum pool as quality control samples. 
  - Define lot number of QC like LL01 LH01,LL02 LH02 ....etc
  - Do entry of QC lot in LIS-> Quality-> reagent, and also change QC lot number in LIS through phpmyadmin--> QC targets and QC. 
  - For low lipase serum pool , collect leftover serum from OPD samples.
  - Find serum lipase > 20 IU/L for 3-4 days.
  - Collect sample in 10 ml vacutte everyday.kept vacutte in deep freeze.
  - After approximately 10 ml serum collected,Centrifuge vacutte at 3000 RPM for 10 minutes.
  - Fill 150 microliter in ependroff cup. Make such 90 such ependroff cups.

===Preparation of quality control samples for Fluid Microprotein===
  - wash 50 ml flask. 
  - take 500 microliter of calibrator((make for two level of calibrators separately)) in that flask.
  - take DI water in flask upto the mark and wrap parafilm over mouth of flask.
  - mix it well.
  - wash 50 ml bottle and fill this diluted calibrators in flask in washed bottle.
  - make approximately 100 cup of MPR calibratorwith 500 microliter volume and airtight cup with parafilm.
  - Define lot number of QC like 5MO1 8M01,5M02 8M02....etc
  - Do entry of QC lot in LIS-> Quality-> reagent, and also change QC lot number in LIS through phpmyadmin--> QC targets and QC.
  - put all cups in deep fridge (-40<sup>o</sup>c).
**Note:** while making cup of 500 microliter shack 50 ml bottle with diluted calibrators intermittantly.

===Preparation of quality control samples for ADA===
  - Make low and high ADA pool as quality control samples.
  - Find ADA < 15 and ADA > 15 for 3-4 days.
  - Collect sample in 10 ml vacutte everyday.kept vacutte in deep freeze. 
  - After approximately 10 ml serum collected,Centrifuge vacutte at 3000 RPM for 10 minutes.
  - Fill 100 microliter in ependroff cup. Make such 90 such ependroff cups.
  - Define lot number of QC like AL01 AH01,AL02 AH02 ….etc
  - Do entry of QC lot in LIS→ Quality→ reagent, and also change QC lot number in LIS through phpmyadmin–> QC targets and QC.

===Preparation of quality control samples for CHE===
  - Take Normal and High range quality control(QC 5 & QC 8)
  - Dilute both level QC five times- take 100 ul QC 5 Or QC 8 and add 400 ul DI water_ 1:5 dilution.
  - Dilute QC freshly when Quality control run. Run QC of one level at a time when test done.
  - During calibration- dilute both level (Normal and high) Calibrator 2 & 3 for 5 times.

===Preparation of quality control samples for Urinary Sodium, Calcium, Phosphorus, Creatinine and Uric acid ===
  - Prepare 6M HCL by adding 2 ml of 12M HCL to 2 ml of D.I. water in 8 ml plastic bottle.
  - for 1ml of urine, 20ul of 6M HCL is added
  - Collect midstream urine from healthy individual in sterile urine container around 20ml.
  - Take another urine container and add 200ul of 6m HCl and take 10ml of the collected urine.
  - Make 50 cups of 200ul each from urine with and without 6M HCL. 
  - Define lot number of QC like UN01,UN02.
  - label the cups containing HCL as UN01, and without HCL as Na UN01.
  - 
  - 
  - Run the test of Urinary Sodium, Calcium, Phosphorus, Creatinine and Uric acid atleast 20 times from collected urine.
  - If precision is constant,Define lot number of QC like Urine IQC001, Urine IQC002, Urine IQC003 ….etc
  - Fill 200 microL urine in eppendroff cup and seal with parafilm, store them in deep freezer.
  - ||{{:nchsls:c:biochemistry:document:urine_ph_sop_1_1_.ods|}}

===Preparation of quality control samples for CKMB===
  -Reconstitute  kit control of CKMB with 2ML of DI Water 
  -Enter lot number and QC target in LIS through phpmyadmin--> QC targets and QC.
  -Upload QC literature for kit control in dokuwiki in SOP of CKMB as Current use kit control.
  -Wait for 15 minutes 
  -Fill the eppendroff cup with 150 microL of kit control and seal with parafilm
  -Approximately 12-14 cups will be filled 
  -store in deep freeze
  -Run control everytime after refilling reagent

===Preparation of quality control samples for CKTOTAL===
  -Reconstitute  kit control of CKMB with 2ML of DI Water 
  -Enter lot number and QC target in LIS through phpmyadmin--> QC targets and QC.
  -Upload QC literature for kit control in dokuwiki in SOP of CKTotal as Current use kit control.
  -Wait for 15 minutes 
  -Fill the eppendroff cup with 150 microL of kit control and seal with parafilm
  -Approximately 12-14 cups will be filled 
  -store in deep freeze
  -Run control everytime after refilling reagent

===Preparation of quality control samples for ketone bodies===
  -Prepare 20 ml urine pool from OPD samples of apparently healthy individual. Divide in to two parts.
Preparation of Positive control
  -In 10 ml of pooled urine- add 10 ul acetone.
  -Prepare aliquotes  of 200 ul and give lot number e.g KP1, KP2, KP3....
  -Seal ependrof cup with parafilm and store then in deep freezer
Preparation of Negative control
  - Take 10 ml of pooled urine
  - Prepare aliquotes  of 200 ul and give lot number e.g KN1, KN2, KN3....
  - Seal ependrof cup with parafilm and store then in deep freezer

===Preparation of quality control samples for Hemoglobin Electrophoresis-Detection of HbS,HbF and HbA===
 {{:nchsls:c:biochemistry:document:patient_consent_for_collection_of_samples_for_iqc_of_hb_electrophoresis.doc|Consent form}}\\
Preparation of HbF control\\
  - Prepare sterile urine container containing CPDA before collecting blood.
  - Collect cord blood from labor room in sterile Urine container with CPDA(49 ml CPDA for 350 ml so for 10 ml blood,1.4 ml CPDA required).
  - Define lot number as F01, F02,F03....etc and its expiry date(2 months from date of collection).
  - Prepare aliquots of 50 ul and labeled it as " F" and preserve it at 2-8 ' C temperature(Do not keep it Deep freeze).
  - Enter data & consent form in LIS---> Calibration.
    
Preparation of HbAS control\\
  - Find out sickle positive patient in which both S band and A band seen properly and take consent for blood collection for preparation of Control. Download Consent Form 
  - Prepare sterile urine container containing CPDA before collecting blood.
  - Collect blood from known case of sickle disease/trait in Sterile urine container with CPDA (49 ml CPDA for 350 ml so for 10 ml blood,1.4 ml CPDA required).
  - Define lot number as AS01, AS02,AS03....etc and its expiry date(2 months from date of collection).
  - Prepare aliquots of 50 ul and labeled it as " S or AS" and preserve it at 2-8 ' C temperature(Do not keep it Deep freeze)
  - Enter data & consent form in LIS---> Calibration.

===Preparation of quality control samples for Dithionite Test -Detection of HbS===
Preparation of HbA control(Negative control)\\
  - Find out Healthy individual or patient in which A band seen properly and take consent for blood collection for preparation of Control. Download Consent Form 
  - Prepare sterile urine container containing CPDA before collecting blood.
  - Collect blood from healthy individual in sterile Urine container with CPDA(49 ml CPDA for 350 ml so for 10 ml blood,1.4 ml CPDA required).
  - Define lot number as A01, A02,A03....etc and its expiry date(2 months from date of collection).
  - Prepare aliquots of 50 ul and labeled it as " A " and preserve it at 2-8 ' C temperature(Do not keep it Deep freeze).
  - Enter data & consent form in LIS---> Calibration.
    
Preparation of HbAS control(Positive control)\\
  - Find out sickle positive patient in which both S band and A band seen properly and take consent for blood collection for preparation of Control. Download Consent Form 
  - Prepare sterile urine container containing CPDA before collecting blood.
  - Collect blood from known case of sickle disease/trait in Sterile urine container with CPDA (49 ml CPDA for 350 ml so for 10 ml blood,1.4 ml CPDA required).
  - Define lot number as AS01, AS02,AS03....etc and its expiry date(2 months from date of collection).
  - Prepare aliquots of 50 ul and labeled it as " S or AS" and preserve it at 2-8 ' C temperature(Do not keep it Deep freeze)
  - Enter data & consent form in LIS---> Calibration.  
  - 
===Preparation of quality controL for HbA1C===
  - Take 10 ml wash solution provided with instrument
  - Add 50 microliter of edta sample cell part in 10 ml wash solution mix throughly
  - Prepare 500 ul of aliquots  parafilmed and labeled it as a HbA1C  QC preserve in deep freeze 
  - Preapre control of 2 range around 6 and 12
  - Run with batch

===Run Quality control sample in Erba XL-640===
  - Take out normal and abnormal quality control.
  - Program QC sample as any other sample in erba XL-640.See How to [[Run samples in Erba XL-640]].
  - For convenience Normal Serum Qc=5 and Abnormal Serum Qc=8.
  - For convenience Normal Urine Qc=4.
  - Format for giving Qc ID=5YYMMDDHH.((Y=year , M=Month ,D=Date ,H=hour))
  - For example,If you are doing Qc 9 a.m. in morning on 13th june,2014 then give Id=514061309 and 814061309.
  - Use the cups as samples as described at [[calibration_and_quality_control_frequency|Currently observed calibration and IQC frequency]]
  - After Qc sample run completed , [[lis_export_result_from_erba_xl_640|Export results from Erba XL-640]] and [[lis_Import_Qc_result|Import QC results to LIS]]
===Run Quality control sample in Erbachem===
  - For manual examination in Erba chem run quality control sample same as patient sample as written in [[list of examination procedures|Individual examination procedures]].
===Preparation of LJ chart===
  - Open 12.207.3.240.
  - Enter user name and password.
  - Click on 'QC--->LJ chart/Today/Show today LJ'.
  - Following window open.{{:nchsls:c:biochemistry:document:lj_chart_screenshot.png|}}
  - Click on EXTRA.
  - Following window open.{{:nchsls:c:biochemistry:document:screenshot2.png|}}
  - Black line in middle=Mean , Green line=1 SD , Blue line=2SD , Red line=3SD.
 
**Interpretation of examination of internal quality control material**
  *At end of a IQC measurement event, follow 1(3S) and 2(2S) rules for rejecting a run/accepting a run.
  *do not release patient results in the event of quality control failure. When the quality control rules are violated and indicate that examination results are likely to contain clinically significant errors, re-examine relevant patient samples after the error condition has been corrected and within-specification performance is verified. 
  *[[Analyse EQA and IQC results]], with results from interlaboratory comparison data to detect trends in examination performance that may indicate problems in the examination system. When such trends are noted, take preventive actions and record them.
  *[[Action taken when 1(3S) or 2(2S) rule violeted|Action to be taken when 1(3S) or 2(2S) rule violated]]
  *Whenever required [[insert QC comment]] in the LIS

=====Interpretation Flow=====
  * For all duplicate testing marks first reading RED, no comment required
  * Number of examination in a given sample out of 2S (rule applicable in our lab only if number of tests done is >10)
      * >5 (See below)
      * <5
          * For each examination out of 2S (Note: For Duplicate testing ignore first reading)
              * Is it Out of 3S
                  * Yes, Reject run
                  * No
                      * See another QC of same batch and Previous QC
                          * 2(2S) violated?
                              * Yes: Take action, Enter Comment
                                  * Repeat from Same QC cup
                              * No: Wait for next QC analysis

=====Procedure when new lot of QC is used=====
  - Overlap new and old lot Quality control sera to allow time for setting target values.
  - After 20 days,[[Sort data for new Qc in Excel sheet]].
  - **For blood gas analysis**, when new lot of QC arrives, it will be run for 2 time ( one in morning and one in evening) and mean will be derived from 2 data.
**Preparing target values and SD:**
   -**Starting a new lot of sera:**When assayed materials are used, the values stated on the assay sheets are used only as guides. Actual values for the mean and standard deviation is established by replicate testing in the laboratory. 
   -**Establishing the Value of the mean on a New Lot :**New lots of control material is analyzed for each analyte in parallel with the control material in current use. Ideally, a minimum of at least 20 results are obtained on separate days. If the desired 20 data points from 20 days are not available, provisional values are set from fewer than 20 days. One approach is making no more than four control measurements per day for at least five different days. 
   -**Establishing the Value of the Standard Deviation on a New Lot :**If there is a history of quality control data from an extended period of stable operation, the established estimate of the standard deviation is used with the new lot. The estimate of standard deviation is reevaluated periodically. If there is no history of quality control data, the standard deviation is estimated, preferably with a minimum of 20 data points from 20 separate days. This value is replaced with a better estimate when data from a longer period of stable operation becomes available. 
   -**Cumulative Values :**Estimates of the standard deviation (and to a lesser extent the mean) from monthly control data are often subject to considerable variation from month to month due to inherent difficulty of estimating a standard deviation from the available number of measurements (e.g., with 20 measurements, the estimate of the standard deviation might vary up to 30% from the true value; even with 100 measurements, the estimate may vary by as much as 10%). More representative estimates is obtained by cumulating the control data from shorter periods of time, e.g., combining control data from six consecutive one-month periods to provide six month cumulative. Care is taken to ensure that the mean is not changing consistently lower or consistently higher for the monthly periods being combined. 
   -**Establishing the Value of the Standard Deviation for new LIPASE/ ADA pooled sera lot :** because there is no internal quality control available for  Lipse and ADA we are taking high and low pooled serum as quality control. because fewer cups and fewer data available for setting SD for LJ chart we are taking weightage based SD.
  -**How to calculate weightage based SD**: calculate the no. of time QC done from same lot and find out there SD and CV.and as the lot change find out subsequent lot SD and CV. and then find out weighted based CV from data. from the weighted based CV find out weighted based SD. Round up this weighted based SD. that will be SD for perticular lot.{{:nchsls:c:biochemistry:document:lipase_cv_calculation.ods|How to find weighted based SD}} 
  -**For Example** {{ :nchsls:c:biochemistry:document:iqc_best_practice.ods |}}

=====  How to make serum pool for IQC of vitros 3600 =====

- First prepare serum pool of two level normal and abnormal of 50 ml in 50 ml plastic wash bottle 
  - Kept at room temperature for at least 2 hr 
  - Mix throughly and filled it in washed plain vaccutte for centrifugation 
  - make allicort of 400 microliter parafilmed it and kept in deep fridge

===== Frequency of IQC of VITROS-3600 =====
  - 1 level on every monday 
  - take two cup from deep fridge 
  - from 1 cup -ferritine,TSH,free T3,free T4 and PCT 
  - from 2nd cup -NBNP2,hsTni,FSH,LH,B-hCG and prolactin
 
=====Criteria for change in Target and SD=====
Criteria for change in Target
  -EQUAS SDI <1
  -delta SDI(Difference btween average mean and  LJ mean is divided by LJ SD) is >0.5
  -If one target is changed, also change target of another 
  -compare with manufacturer's mean, if it is comparable, change the target.
  -If not comparable, look at calibration. If manufacturer's mean is achieved, there may be interfernce in equipment.
Criteria for change in SD
  -20 % change in SD
  -change in method / equipment
  -No. of available data should be >60

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Dr Piyush Tailor

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