STATS INTERLABORATORY QUALITY CONTROL PROGRAM

INTERL ABOR ATORY QUALIT Y

CONTROL PROGR AM

STATS

®

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.

E N RO L L M E N T

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 800-843-0912 or the STATS Department at 800-898-9563. 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.

H O W I T W O R KS

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.

GETTING STARTED

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

Customers who select to participate in STATS-Link, the

online option, receive e-mail 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 e-mail 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.

E XC E L S U B M I S S I O N FO R M

Interactive template forms for daily and summary submission, like the sample shown here, are available at streck.com.

SUBMITTING DATA

E - M A I L 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 e-mail 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 submission period.

• Review the data for each level and delete any data or dates that should not be processed for the submission period. 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 submission period.

Prepare all e-mail submissions with the following information:

• To: [email protected]

• 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 confi rmation e-mail will be sent when the data is received by the STATS Department.

Enter the assay means and ranges to activate the highlight alerts to clearly show out-of-range data.

SUBMITTING DATA

FA X 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.

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.

FREQUENTLY ASKED QUESTIONS ABOUT STATS

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 confi rmation provided to customers when data is received by STATS?

If data is submitted via e-mail, a confi rmation e-mail 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.

• Review the data for each level and cross out any data or dates that should not be processed for the submission period.

• Ensure print is legible and dark enough for fax

transmission. As an alternative, data can be scanned,

320599-1

ESR-Chex

Lab Acct Number: 00100

Lot Number 1024 Date From Due Date Date Received Date To Instrument Number 166 Shift 1

Instrument/Serial Number - ESR-Auto Plus™ (1.2 ml) 5043559 (#1)

01/07/2012 12/11/2012 11/01/2011 11/30/2011 SAMPLE LAB REPORT

1234 MAIN STREET ANYTOWN, NE 12345 USA

Current Submission Number of Labs: 45

Cumulative Submissions Total Number Of Labs: 523 Level 1 10241380 Para-Meter Assay Mean Your Mean Your SD Your CV Group Mean Group SD Group CV S.D.I. Group N Your Mean Your SD Your CV Group Mean Group N Group CV S.D.I. Group SD General Report ESR 9 8 1.43 18.68 8 5192 1.51 19.67 -0.03 8 1.24 16.32 8 39330 1.57 20.12 -0.13 Current Submission Number of Labs: 45 Cumulative Submissions Total Number Of Labs: 524 Level 2 10241381 Para-Meter Assay Mean Your Mean Your SD Your CV Group Mean Group SD Group CV S.D.I. Group N Your Mean Your SD Your CV Group Mean Group N Group CV S.D.I. Group SD ESR 91 89 3.70 4.16 92 5220 5.03 5.49 -0.54 89 4.18 4.67 92 39570 5.51 6.01 -0.44

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. 2

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.

3 A 4 3 B 2 1 • Your Data Group +2,-2 SD Group Mean 91.60 Assay Mean 91.00 Assay Range 73.00-109.00 Your Mean 88.90 5 108.00 104.00 100.00 96.00 92.00 88.00 84.00 80.00 76.00 05 10 15 20 25

FREQUENTLY ASKED QUESTIONS ABOUT STATS

STAT S S U PP O R T

• STATS Department:800-898-9563 / 402-691-7495

• Submit STATS data:

› Fax:402-333-7874

› E-mail :[email protected]

› Mail Attn: STATS Dept, Streck, P.O. Box 45625, Omaha, NE 68145-0625 • STATS-Link:streck.com

CONTACT US

• Streck product information, including IFUs and Assays: streck.com