How do I register for the Nova Quality Assurance Program?
Please contact the Quality Assurance Program Specialist at 800-458-5813 x 1441 or by email to QAP@novabio.com.
Who do I contact for QC questions or technical problems?
All technical or applications questions may be addressed to the QAP Administrator at 781-894-0800 x 1441 or by email to QAP@novabio.com.
Our in-house Technical Product Specialists can also assist with any technical questions you may have. They can be reached through Nova’s Technical Support Hotline at 1-800-545-6682.
Who do I contact to request forms, reports or to make corrections?
All requests for data entry forms, reports or corrections should be directed to our QAP Administrative Assistant at 800-458-5813 x 1441 or by email to QAP@novabio.com.
How much material do I have to sequester?
We request that you sequester at least one year of quality control material to ensure continuity. You will be assigned to a lot number of quality control material, and become a member of the peer group using that particular lot number.
How long is my commitment to the QA Program?
Your commitment begins when you register and arrange for the Quality Control material to be sequestered. You are considered a member of the Nova Quality Assurance Program until the end of your sequestered lot. You will be sent a reminder to renew your registration 60 days prior to the end of your commitment.
How is the material delivered?
The preferred method for shipping is bi-annually or quarterly. Special arrangements can be made for alternate delivery schedules as needed. Normal delivery is second day, however, overnight with AM delivery is available in case of emergencies. Heat sensitive material is shipped on cold packs.
What are the reports and statistical services available to QAP customers?
The following reports are available monthly of each analyzer registered in the Nova Quality Assurance program: Data Summary Report, Data Verification Report, Data History Report, and the Data Exceptions Report. Through the Quality Assurance Program, a laboratory will have the following monthly information:
- Current Lab Mean, SD, and CV
- Historical trending of the Mean, SD, and CD
- Inter lab comparison with other members of the Peer Group
- A summary of any exceptions observed in the monthly data Submission
How big is the peer group?
The size of the peer group varies depending on the number of instruments registered to a particular lot number of control. Please remember that group statistics cannot be generated until there is a minimum of five instruments in the group.
How do I know if my QC is in control?
When analyzing a quality control specimen, your Nova analyzer will generate a flag to indicate that your control did not pass. On your QAP report, the Exceptions Report will indicate whether the QC is within specification, or if not, will indicate the mode of failure for each analyte that is out of control. All QC failures should be investigated.
When do have to submit my monthly statistics?
All data must be received by the 11th of each month. When the 11th falls on a weekend, the data must be received the Friday prior to be included in peer group statistics. Data received after the cutoff date will be processed for lab statistics only.
How long after submission will my report be ready?
Reports will be available on the 15th of the following month unless it falls on a Holiday or weekend in which case it will be available on the next business day.
What is an “SDI”?
The Standard Deviation Interval (SDI) compares your laboratory’s mean to the peer group mean. It is an indication of bias. A negative SDI indicates low recovery, while a positive SDI indicates that your analyzer is running higher than the peer group. The traditional limits for SDI are +/- 2.0.
The calculation for SDI is:
SDI = ( Lab Mean - Peer Mean Peer) / SD
What is an “N”?
“N” is the Number of data points submitted for the month. An “N” of at least 7 data points is required for submission.
What are Fixed Limits?
Due to the superior performance of today’s technology, it may be possible that your analyzer is generating SD’s and CV’s that are significantly tighter than posted specifications. To maintain this level of tighter performance may require needless troubleshooting and expense. While of statistical significance, this variability may not represent clinical significance. Many certifying agencies now recommend the use of Fixed Performance Limits for evaluating laboratory performance.Fixed Performance Limits represent the Peer Group mean with fixed limits around the mean that the lab's mean should fall within. The limits are based on many months of tracking the typical performance of the analyzer through different reagent, control changes and sensor aging.
Do I have the option of using either +/- 2 SD or Fixed Limits?
The laboratory has the option of using one, or the other, or a combination of both methods to evaluate instrument performance. The goal should be to insure the highest reliability of results while minimizing unnecessary, troubleshooting and maintenance.
What is an Exceptions Report?
The Exceptions Report is a summary of any exceptions observed in the data submitted for the month. A brief statement appears if there were no QC failures during the month. If there are QC problems, exceptions are listed by analyte and control level along with a brief description of the exception observed. There is space provided on the Exception Report to document any corrective action needed. There is also space provided for the acceptance signature of the reviewer. The Exception Report provides a snapshot view of the month's QC activity simplifying the review process.
What should I do if my QC comes out “Failed”?
Contact Nova Technical Support at 1-800-545-6682.
Some of my data points are outside of the package insert. May I accept these points?
The package insert represents the range that the mean of your data must fall into.Depending on the model and instrument differences within a model your mean may be on the upper or lower side of the package insert range. If the mean is on the extreme edge of the package insert, there could be occasions when the value recovered is actually outside of the package insert. Please remember that each lab must establish its own QC range. The package insert is there to serve as a guideline. To determine if the results are acceptable, you may refer to the Data Summary Report. Compare your mean, SD, and CV to the Model statistics on the report. If your analyzer is showing similar performance, then the results are acceptable.
How can I do crossover studies on a pHOx, pHOx Ultra, Prime or Prime Plus analyzer?
Protocol For Lot To Lot Crossover
Crossover to a new Lot of Quality Control Material
Periodically there will be a need to change over to a new lot number of internal QC material on your analyzer. This will happen when the current lot expires, or you have run out of supplies and must order new QC material. The analyzer can accommodate only one box of QC material at a time (note: CCX can accommodate only one of each type of QC material at a time). It is not possible to run parallel lots of internal QC at the same time. With the installation of a new lot number of onboard QC, the data from the previous lot number is erased from the memory on the pHOx analyzer. Please note that the statistics of each lot on the CCX/pHOx Ultra, Prime and Prime Plus is kept in memory, however, it is not recommended to switch between boxes of different lot numbers of onboard control.
In order to facilitate the crossover to a new lot of onboard control, Nova recommends the following protocol.
- 1. Acquire a sufficient amount of Nova External Quality Control (amounts will vary depending on your QC requirements)
- 2. Establish the QC range for the external controls by analyzing a sufficient number of replicates for each control. (Nova recommends an N of 20)
- 3. After a sufficient number of data points have been collected, enter the established values and ranges into your analyzer.
- 4. When the crossover is to commence, remove the old lot of onboard QC and install the new lot number.
- 5. Analyze a sufficient number each level of onboard controls. (Nova recommends an N of 20)
- 6. During the data collection period, analyze the external controls as your daily QC.
- 7. Verify that the external QC is within the range that you have established. If QC is within established ranges, you may analyze patient specimens. If QC fails, troubleshoot and correct the problem then reanalyze the QC.
- 8. When a sufficient number of onboard QC have been analyzed, verify that the range is acceptable.
- 9. If acceptable, enter the new range for the onboard QC into your analyzer.
- 10. You may proceed with analyzing patient specimens, using the onboard QC to monitor the instrument performance.
What are my options for data submission?
You may submit data to the Nova Biomedical QAP several ways.
- Submit your data through the Nova Biomedical QAP Website, QAP.novabio.com
- Fax your data to the Nova QAP Administrator at 1-781-894-4683
- Mail your data to:
Nova Biomedical
Quality Assurance Program
200 Prospect Street
Waltham, MA. 02454-9141
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