Follow these general instructions when preparing and sending your test results.
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.
When handling specimens from AAB-PTS, follow all precautions and recommendations from CDC and FDA, as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). 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 wearing a face shield or other appropriate eye, nose and mouth protection.
- 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 biohazardous waste.
Receipt of the Kit
- 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.
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 2012 schedule on page 3 is unsatisfactory performance and results in a score of 0 for the testing event.
Per CMS requirement, under no circumstances should you ever send any proficiency testing sample to another laboratory for testing. This emphatically includes samples that you would normally send out for confirmation or follow up identification. This is to be followed REGARDLESS of your laboratory policy on such follow up testing. CMS will immediately revoke the license of any laboratory found to be referring proficiency testing samples, even if they are following their laboratory procedures for confirmation. Equally, CMS requires that you not perform testing on any sample that you suspect may be a proficiency testing sample received from another laboratory. You also must report laboratories you suspect of such activity. Severe penalties will apply to laboratories that perform proficiency testing for other laboratories or sites as well.
- 1. See the sample reporting form on page 6 for more specific instructions on executing the forms.
- 2. To submit results via the internet, please see the instructions for online reporting in the Program Guide or click
- 3. The attestation statement on the front or 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 at the end of the Program Guide.
- 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 shipping schedule and on each reporting form.
- 7. Late results will not be processed and will be scored as zero.
- 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
Each shipment includes Instruction sheets. Do not return the instruction sheets with your reports as they are for your use.
Method Data sheets are included with each shipment, which include your specific reported Method Codes from the last reporting event. These Method Data sheets are only carried for one quadrimester and then are deleted. Since this data will determine how your 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). One exception is the Method Codes for WHOLE BLOOD GLUCOSE. These must be entered each time.
When coding your methods, ensure that you use current method codes. Refer only to those codes 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. Paperclip 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
All scores for CLIA regulated analytes are automatically sent to CMS and State Agencies. Results are also sent to COLA for participants that supply a COLA number. Scores will appear on the CMS cumulative score sheet only for those analytes that are regulated. The lists below indicate the priority assigned for reporting CLIA equivalent analyte groups to report to CMS. If you would prefer that different analyte from a group be preferentially sent to CMS, please let us know in writing as to your preference and we will be happy to accommodate your needs.
Serum pregnancy, (qual-Basic Ch)
Serum pregnancy, (qualitative)
Urine pregnancy (qualitative)
Anti-HIV-1 or 1/2 Screen
HIV-1 p24 Antigen
Oral Fluid HIV Screen
Oral Fluid HIV Western Blot
Cardiac Markers/Isoenzymes, Plasma
Prothrombin Time (PT)
Whole Blood Prothrombin Time
Coaguchek PT, Comp
Coaguchek PT XS Comp
Hemachron Whole Blood PT
Whole Blood Glucose
Hematology w/Diff A, B, C, D, E, F, G
RPR, RST, trust
Please follow all directions in filling out your reporting form completely, including the “YES” and “NO” boxes for CMS reporting. Once a report is graded, CMS does not allow for corrections due to participant’s clerical and/or omission errors.
CMS requires that laboratories failing to participate in testing events to be given unsatisfactory performance and results in a score of 0 for that testing event. CLIA Law states in PART 493–LABORATORY REQUIREMENTS, Subpart H- 493.823(b) the following:
Sec. 493.823 Standard; Bacteriology
- (b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if–
- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results;
- (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and
- (3) The laboratory participated in the previous two proficiency testing events.
If the evaluation of your results indicatesthat corrective action is necessary, the Corrective Action Forms on pages 28-29 of the program guide may be copied and completed for your internal records. Do not submit these forms to AAB as it is for your internal use only.
Address changes must be received in writing by either fax, email, 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.
A cancellation notice, on institutional letterhead, must be received by either 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.