STATS INTERLABORATORY QUALITY CONTROL PROGRAM

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1 STATS INTERLABORATORY QUALITY CONTROL PROGRAM The Streck STATS program is an effective way for laboratories to evaluate the performance of their instrument or method against a peer group and demonstrate compliance with quality practices. Peer groups are comprised of other labs using the same instrument, method and control lot number. STATS compiles data in personalized, easy-to-read reports to help labs detect changes in their systems before these signifi cantly impact patient results. An online report option, STATS-Link, allows labs to view current and archived reports. STATS is available to all customers and is always free of charge. streck.com

2 STATS REPORTS INCLUDE Interpretive comments which clearly explain the value and purpose of each component and calculation contained in the report Data exclusion page identifi es data outliers to facilitate prompt corrective action Peer group comparisons include essential lab and group statistics for the current submission period and cumulative data collected throughout the lot Levey-Jennings graphs on select parameters to easily identify shifts or trends SDI Reports for evaluation of bias compared to the group Historical Data Comparison Report, a chronological presentation of SD and CV over multiple submissions or lots, aids in establishing individual laboratory means and evaluating performance over time Consolidated Manager s Report, customized comparison data for administrators of multiple laboratories using a common method or instrument GETTING STARTED ENROLLMENT Enrollment in STATS is easy and only takes a few minutes. Enrollment forms can be downloaded from the STATS page on streck.com or customers can contact their Streck Sales Representative at or the STATS Department at Customers can enroll multiple products and/or instruments; enrollment forms are quickly processed and Welcome Packets with all the information needed to get started in the program are sent to new enrollees. HOW IT WORKS STATS reports are processed on a monthly basis. The STATS Due Date Schedule lists the due date for each product; it is included in the Welcome Packet and is also available at streck.com. Monthly data submission is encouraged so labs can monitor results throughout the dating of each lot. On each product s submission due date, customer data is sorted by lot number and instrument type, and entered into the STATS data system for statistical analysis and peer group comparison. Reports are generated and issued to customers within six business days following the monthly due date. Customers who select to participate in STATS-Link, the online option, receive notifi cation when reports are available and can immediately access reports via their secure STATS-Link account. Reports are archived and accessible for 12 months. Customers who do not participate in the online program receive reports via standard mail three to seven business days after the reports are generated. Customers can select to receive reports electronically during enrollment in the STATS program or at a later date. Additional supplies can be requested via the Supply Reorder Form on the STATS page. Please notify STATS of any laboratory updates such as instrument additions or upgrades, changes to existing equipment including serial number or software changes, or changes to laboratory contact information to ensure data is appropriately processed each month. STATS accepts data via and fax. To ensure proper processing, please include the lab #, instrument #, lot #, shift # and start and end dates with each submission. If submitting data for multiple instruments, shifts or lots, use separate forms or fi les. All data will be processed as shift 1 if the shift number is not indicated with the data. STATS representatives can provide guidance on determining the best submission method for each product.

3 SUBMITTING DATA DATA Instrument Files Consult the instrument manual for instructions on downloading QC data to a disk or fl ash drive. Download only the data from the instrument s QC fi les that should be processed. Once the data is saved, insert the disk or fl ash drive in a computer with access. Excel Submission Forms Customized Excel submission forms for both Daily and Summary submission methods can be found on the product s page on streck.com. To ensure your lab is using the most current form, download a new form prior to each data submission. Save the form with the data for the current Review the data for each level and delete any data or dates that should not be processed for the Be sure the form contains the lab #, instrument # and lot #. PDF Files Instrument QC fi le print-outs or any manual data forms can be compiled into a PDF. Be sure the data includes the lab #, instrument # and lot #. Create and save the PDF for the current Prepare all submissions with the following information: To: statsdata@streck.com Subject: Your Lab Name and Your Lab Number Message: Product Name, Lot Number, Instrument Name, Instrument Serial Number Attachment: Control fi le(s) for the appropriate level(s) A confirmation will be sent when the data is received by the STATS Department. EXCEL SUBMISSION FORM Interactive template forms for daily and summary submission, like the sample shown here, are available at streck.com. Enter the assay means and ranges to activate the highlight alerts to clearly show out-of-range data.

4 SUBMITTING DATA FAX DATA Faxes should include a cover page indicating the total number of pages sent, lab name, lab #, product name, lot # and shift #. If submitting data for multiple lots, instruments or shifts, include a separate cover page for each data set. Please include the lab # and lot # on every page. Review the data for each level and cross out any data or dates that should not be processed for the Ensure print is legible and dark enough for fax transmission. As an alternative, data can be scanned, saved as a PDF and ed to STATS. FREQUENTLY ASKED QUESTIONS ABOUT STATS Is participation in an ILQC program required? Participation in STATS is not required; however, it is encouraged by regulatory organizations which provide guidance for good laboratory practice. Each STATS report includes a Reviewed By section for managers to sign and date to indicate the report was received and reviewed. Two standards on the importance of interlaboratory participation include ISO 15189:2012 (5.6.3) and CLSI C24-A3, Vol. 26 No 25. Are a minimum number of data points required to participate in STATS? No. Streck will process reports with any amount of data received. If only submitting summary data, submit the mean, SD and N for all parameters tested to be compared with each parameter for the group. Submit daily run data for a comprehensive report. Does data need to be submitted every month? No, although monthly submission is encouraged so each lab can monitor QC and peer group data while the current lot is in use and quickly address potential problems. When is data due? Each product has a specifi c monthly due date; dates vary by product. Refer to the Due Date Schedule on the STATS page at streck.com. What if the due date is missed? How far back is the data accepted? Data can be submitted at any point during the month and will be held until the product due date. If data is received after the data is processed for that month, it will be held and processed the following month. There is no need to resubmit data the following month. Data will be accepted up to 6 months past each lot s expiration date. Is a confirmation provided to customers when data is received by STATS? If data is submitted via , a confi rmation is sent to the customer. Confi rmation is not provided for data submitted by any other method. Contact the STATS Department with any questions or concerns regarding submitted data. What if previously processed data is submitted with new data? Before data is submitted by any method, it should be reviewed and previously submitted data points should be excluded from the fi le by deleting the run or simply crossing a line through the data that should not be processed. On the Excel Submission Forms, be sure to list the start and end dates for the current submission. Excluding old data will avoid biasing the peer group data. Contact the STATS Department with any questions regarding submitted data.

5 FREQUENTLY ASKED QUESTIONS ABOUT STATS 3A Lab Acct Number: SAMPLE LAB REPORT 1234 MAIN STREET ANYTOWN, NE USA General Report ESR-Chex Instrument/Serial Number - ESR-Auto Plus (1.2 ml) (#1) Lot Number 1024 Instrument Number 166 Shift 1 Level Group Group Group S.D.I. Your Your Your N SD CV Mean SD CV Due Date 01/07/2012 Date Received 12/11/2012 Date From 11/01/2011 Date To 11/30/2011 Cumulative Submissions Total Number Of Labs: 523 Group Group Group Group S.D.I. Mean N SD CV ESR Current Submission Number of Labs: 45 Para- Assay Your Your Your Group Meter Mean Mean SD CV Mean Current Submission Number of Labs: 45 Para- Assay Your Your Your Group Meter Mean Mean SD CV Mean 1 4 Group N Level Cumulative Submissions Total Number Of Labs: 524 Group Group S.D.I. Your Your Your Group Group Group Group S.D.I. SD CV Mean SD CV Mean N SD CV ESR B If data for multiple instruments is submitted, how is it noted on the report? Laboratory and instrument information is listed at the top of the report, including instrument name and serial number, lab contact information, lab # and lot #. 1 If data for multiple months is submitted, how is it noted on the report? Each report will list the dates included in the report as well as the date the data was received at STATS and the due date for the period Your Data Group +2,-2 SD Group Mean Assay Mean Assay Range Your Mean Why is the number of labs listed for current and cumulative submissions different? The left side of the report (Current Submission 3A ) lists the number of labs that submitted data in the most recent report period. The right side of the report (Cumulative Submissions 3B ) is the total number of labs that submitted for this lot for all report periods. Is peer group data included in the report? Peer group data will be included in all summary and detailed reports if at least one other customer in the instrument group has submitted data for the lot. Group data calculations will be provided on the General Report 4, as well as on the Levey-Jennings graphs 5 and S.D.I. charts. CONTACT US STATS SUPPORT STATS Department: / Submit STATS data: Fax: statsdata@streck.com Mail Attn: STATS Dept, Streck, P.O. Box 45625, Omaha, NE STATS-Link: streck.com STRECK SUPPORT Sales Department: Customer Service: Technical Service: x 7510 Streck product information, including IFUs and Assays: streck.com