General Instructions

General Instructions
Follow these general instructions when preparing and sending your test results.

Precautions
All units of human blood or blood products used in preparing specimens, except those used in the Hepatitis and HIV Markers program, have tested negative for HBsAg, HCV antibody and HIV antibody at the donor level. Precautions described in CDC and FDA recommendations and OSHA blood borne pathogen rules should be followed when handling these specimens. These recommendations and rules include but are not limited to the following:

1. The specimens should be handled only while wearing impermeable gloves.
2. Gloves should be replaced if torn or contaminated.
3. Specimens should be opened in a hood or biological safety cabinet.
4. Do not pipet by mouth.
5. No eating, drinking or smoking is allowed in the laboratory.
6. Before leaving testing area, wash hands after removing gloves.
7. Specimens should be disposed of as hazardous waste.

1. Samples are shipped via Federal Express.
2. E-mail notification of the FedEx tracking number is sent the day of each shipment to those participants that have registered for email services.
3. Open immediately upon arrival. Check for damaged or missing specimens.
4. Call 800-234-5315 if replacements are required. Replacements will be sent only until the Monday following the shipment date. Hours are Monday thru Friday 8 a.m. - 5 p.m. Central Time.
5. Refrigerate specimens until they are analyzed.
6. Participants are responsible for notifying AAB when the testing kit has not been received within 3 days of the shipment date.
7. Alternate shipping dates cannot be provided.

Testing Regulations
The Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) requires PT specimens to be analyzed as if they were patient specimens. To be in compliance you must not delay testing PT specimens unless your patient testing is also being delayed. Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Failure to return PT results or have them postmarked by the cut-off date displayed in the 2008 schedule on page 2 is unsatisfactory performance and results in a score of 0 for the testing event.

1. See the sample reporting form on page 5 for more specific instructions on executing the forms.
2. To submit results via the internet, please see the instructions for online reporting on page 4.
3. The attestation statement on the reverse of the Centers for Medicare and Medicaid Services (CMS)-scored analytes forms must be signed for each analyte by the analyst performing the procedure. In addition to the analysts' signatures, the director or the director's designee must sign only once for each reporting form. The designee for moderate complexity testing is the technical consultant while the technical supervisor is the designee for high complexity testing. There is no attestation statement for non-CMS scored modules (1 & 2 vial programs). If your state or other regulating agency requires attestations for these programs, please use a copy of the general attestation form found on page 21.
4. Retain photocopies of your results and submit the red printed originals in the envelope provided. For online results, click the finish button to submit your results. Be sure to print the final results page which includes your confirmation number. No corrections can be made for any results without a confirmation number.
5. Telefaxes and photocopies are not acceptable. Originals are required for optical scanning.
6. Results must be postmarked by the cut-off date displayed in the 2008 schedule and on each reporting form.
7. AAB is not responsible for reports lost or delayed in the mail service. Late results will not be processed.
8. AAB is not responsible for results lost in the mail. Please consider taking advantage of our online reporting. If online reporting is not an option for you, consider the use of either an overnight service or a 2-day service that can provide confirmation of delivery.

Coding Your Methods
A Reporting Form Instruction Sheet is included with each shipment. The back of this sheet lists method data on file only for analytes for which results were submitted in the most recent survey. Since this data will determine how currently reported results will be evaluated, please verify the entries in this list. If an entry is correct, do not recode it.
If entries are missing or incorrect, please amend this list by coding/recoding method data directly on your results form(s). Methods for whole blood glucose and antigen screens must be entered each time. Do not return the Instruction Sheet.

To code methods, ensure that you use current method codes by referring only to those listed in red and white reporting form, the General Instructions pages or the Method Code Addendum for the current event. Only method codes (not method descriptions) can be used to code participants' methods on the reporting forms. If no acceptable method description can be found in the method list, leave the method code blank, paper clip a package insert and/or method description to the report and we will code your method. Please write your AAB account number on the insert to allow us to match the new method with your results. If you do not report, or if you are late in reporting your results for an event, your method codes will be deleted from our database. You must recode all methods, reagents and instruments the following event or your results will be graded as “Method Code Not Reported.”

Coding a method other than the one actually being used usually jeopardizes a participant's grading, even when results are transformed to mimic those of the method coded. We strongly recommend that participants report their results without transforming them to look like results from a method other than the one actually being used. Reporting untransformed results is not in violation of CLIA '88. CLIA '88 mandates that sample processing (not result processing) conform to that routinely applied to patient specimens.

CMS SCORING INSTRUCTIONS
To have your scores sent to CMS, your State Agency or COLA, place an "X" in the YES boxes on the reporting form. These boxes must be marked each reporting event. Scores will appear on the CMS cumulative score sheet only for those analytes that are checked YES. If the boxes are checked NO, no scores will be sent to CMS and will be indicated by a “DC” on the cumulative report unless state regulations override your request.

Choose only one analyte within the following groups to report to CMS. If multiple analytes are marked, only scores from the first listed analyte will be sent to CMS.

Address Changes
Address changes must be received in writing by either fax or mail on institutional letterhead. Notice must be received 14 days prior to the next shipment date for the address to be updated. Participants will be responsible for shipping charges to resend a shipment due to a late address change.

Cancellation Policy
A cancellation notice, on institutional letterhead, must be received by fax, email or mail 21 days prior to the shipping date in order to receive a credit or refund on a future shipment. Late enrollments received within the 21 days prior to the shipment waive the cancellation policy and no credit will be issued. The registration fee is nonrefundable.