Effective Date: 
Tue, 05/01/2012
Thu, 05/27/2021
Thu, 05/27/2021


To identify control materials used throughout the laboratory and to formulate a comprehensive plan to perform, monitor, evaluate and take corrective action with control values obtained. A comprehensive quality control plan allows laboratory personnel to record and monitor the daily performance of the analyzers and reagents used throughout the laboratory and to predict shifts and trends in control materials over a period of time.

Expiration date checking is a component of Laboratory Quality Control, and all products with expiration dates are checked monthly, with any expired or expiring products sequestered and removed from use.




The Abaxis Piccolo is a Chemistry test system that incorporates internal quality control mechanisms that monitor all potential sources of error throughout the testing process. The Piccolo self—calibrates with each patient run, utilizing the onboard, continuous intelligent Quality Control (iQC), which monitors the analyzer, reagent reactions and sample to ensure chemistry and instrument integrity. As a waived test system external quality controls are run (per manufacturer) after each shipment, each different lot # or every 30 days, whichever comes first.

It is also important to check QC in the following situations:

    a. Whenever laboratory conditions have changed significantly

    b. When training or re—training of personnel is indicated

    c. When test results do not match patient symptoms or clinical findings


Control testing ensures that you are running the test correctly and that your FastPack® IP System is working properly. When control testing is performed, two control levels must be used. Qualigen recommends that users run controls whenever:

• Monthly, when patient testing is performed.

• A calibration is performed.

• Repair maintenance is performed.

• Improper storage or handling of FastPacks® is suspected.

• Questionable patient results are obtained.


1. Three levels of XN-L Check controls are run daily, prior to running patient samples, and after daily maintenance has been performed.  Daily Maintenance consists of starting up the instrument, which self-tests mechanical and hydraulic parts and verifies temperature stabilizaton. The self-test takes 15 minutes.

 2. lt is also important to check QC in the following situations:

  •  after replacement of reagents
  • . after instrument maintenance, if instructed by technical support
  •  when there is a concern about the accuracy of analysis values


Run Contols every 30 days, each new lot, each new operator(Run controls at the first of each month so that patient testing may proceed quickly.)



  1.  Run a normal and abnormal control each day of patient testing.
  2.  Run controls when a new container of strips is opened or when there is a new operator.
  3.  Controls should also be run if results on strip do not match the clinical picture of the patient and verification of test strips must be made.

Waived Kit Testing:

1. Follow manufacturers instructions for frequency of contol runs. Outside of scheduled control timing, controls must be run for each new lot, each new shipment and each new operator. 



1. Accept the run if:

a. Both the controls read within +/- 2 SD of the established mean.

2. Reject the run if:

a. Any control is greater than 2 SD from the established mean.

3. If the run is rejected:

a. Rerun the controls. If they are still outside acceptable limits, make up fresh controls and rerun. If the controls are within limits, run and report patient results.

b. If after the rerun, the controls are still out of acceptable limits, check the following variables: expiration date of reagents, change in lot numbers of controls or reagents, date of last calibration, and maintenance procedures.

c. If control values are still unacceptable, troubleshoot according to the manufacturers guidelines.

d. If the situation persists, do not run patient samples. Send specimens to the appropriate reference laboratory, according to the patient’s insurance carrier stipulations.

e. When the situation is corrected and controls are again acceptable, patient testing may resume and results may be reported.



A pictorial representation of quality control results, such as Levy-Jennings graphs, is a valuable tool for assessing control results. These graphs can illustrate a method’s accuracy and precision over time. Normally assayed material should show a random pattern clustering around an expected target point. Problems with the instrument, reagents, controls materials, and operators can be assessed by examining these graphs weekly to look for unexpected patterns.


A sudden change in direction, either up or down, of the values you are obtaining is called a shift. A common cause of this is changing to a new lot of reagents. As long as controls are still within range, you may continue to report outpatient results, but you should investigate the shift to eliminate the possibility of erroneous testing. You may need to recalibrate the analyte to resolve the shift in quality control values, but small shifts may be acceptable with the introduction of new lots of reagents.

A trend is when you observe five or more consecutive values which are progressively higher or lower than the stated mean. A number of factors can cause a trend, including deteriorating controls or reagent, instrument component failures, the need for instrument maintenance, drift in calibration, changes in standard lot number, or bacterial growth in your control material. Check to make sure there has been no change in reagent, control or standard lot numbers, beginning with the date the trend started. Proceed with the following steps:

• Try a new bottle of control

• Open or reconstitute new reagent

• Troubleshoot the instrument using the manufacturer’s guidelines or call the customer service representative

Again, as long as your control values are still within range, you may report outpatient results, but it is necessary to evaluate a trend to eliminate the possibility or reporting erroneous results.


"Assayed" controls have stated means and standard deviations in their product literature; however you should verify the established means and adjust them to your facility as necessary: ·

1. You may begin patient testing with the stated means and ranges, but you should gather at least 10 control points for each level in use.

2. The sum of these points divided by the number of samples run is your "actual mean" for that control.

3. Use this number to verify the "established mean" as stated in the manufacturer’s literature. If it is different, then adjust the mean and standard deviation to more closely reflect those established for the facility.

4. After 50 and 100 points are gathered, examine the resulting mean and Standard Deviation (SD) and make further small adjustments as necessary.

5. Once the laboratory’s mean and range is established it should then not be changed until the lot number of controls is changed. Any unexpected trends or shifts should be investigated as possible instrument, reagent, or control problems.

When "unassayed" control material is used, generally this means that the manufacturer has not established a mean for your instrument and/ or reagent. Therefore, a new mean and standard deviation will have to be determined each time a new lot of control material is to be put into use. This is should be done before existing control lots expire. You would also do this if a new brand of controls will be used, a new procedure is implemented or new equipment is acquired. It is important to perform this procedure in an adequate time frame, usually at least two weeks in advance of the change:

1. Identify the date for the change, preferably the first day of the month.

2. In the instrument QC program, input the manufacturer suggested mean and SD for each parameter if this information is available. If not, enter data for a method similar to the facility’s method.

3. Run the new control once a day, or in a morning and afternoon run.

4. Continue to run the old lot of control material as well, until sufficient data for the new lot of control has been established.

5. When at least 2O points of the new control material have been accumulated, determine the new mean and SD for each parameter.

6. When the old lot number of control material has been used up or is expired, the new one will be placed into use on the test system.

7. Once the new lot of control material is started, do not submit data from the old lot of QC to the evaluation or QAP program.

If for any reason, there is not enough time to perform the unassayed control procedure as established, use the following method:

1. Run the new control twice per day, in the morning and afternoon.

2. Obtain 10 points of data.

3. Use the mean from these points and the SD from the control insert sheet.

4. Review the data when 20 points are obtained to make adjustments as necessary.


Quality control graph records should be retained for a minimum of two years for all non-waived quantitative procedures. Electronic storage is acceptable, as long as the information can be accessed and as long as an electronic copy of the information is kept as a back-up. It is prudent to check this storage system periodically as a part of Quality Assessment.

Documentation of review of Quality Control Graphs, and/or individual quality control points is required. These graphs or points should be reviewed by the Laboratory Supervisor or designee at least monthly. Corrective actions can be documented directedly on the printouts. If review of electronic records is performed, this must be documented as well.


Some control materials offer a QAP program. Monthly control data may be downloaded from the analyzer computer system and sent to the QAP company for a compilation of both individual data and peer group comparison.

This information should be reviewed monthly by the Laboratory Supervisor and corrective actions performed and documented as needed.


For analyzers or testing that do not have on-board compilation of quality control data, either a log will be kept to document quality control values, or they may be placed on the worksheets, along with any tapes or reports from the analyzer to show testing of quality control material. Review of these should also be performed monthly and documented.

Key Points: 

See individual test policies for specifics.