General Instructions

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.

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

• Samples are shipped via Federal Express.
• E-mail notification of the FedEx tracking number is sent the day of each shipment to those participants that have registered for email services. Call Customer Service to register. 800-234-5315.
• Open immediately upon arrival. Check for damaged or missing specimens.
• 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.
• Most samples require refrigerated storage upon receipt and some frozen storage if not testing immediately.  Please open the kit and read storage instructions.  Special instructions beyond refrigeration is found on the program reporting forms and in this Program Guide. Store samples as directed until they are analyzed.
• Participants are responsible for notifying AAB when the testing kit has not been received within 3 days of the shipment date.
• 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 schedule and on the bar coded reporting form 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.

REPORTING RESULTS

• See the sample reporting form on page 9 for more specific instructions on executing the forms.
• To submit results via the internet, please see the instructions for online reporting or go to the website, www.aab-pts.org, for instructions.
• The attestation statement on 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 an attestation statement for non-CMS scored modules (1 & 2 vial programs). If your state or other regulating agency requires attestations for these programs, complete the general attestation form that is provided with your reporting form.  CAP Participants, please note.  The College of American Pathologists requires a signed attestation for all analytes.  
• Retain photocopies of your results and submit the original printed forms in the envelope provided. For online results, be sure to click the SUBMIT button. 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.
• Photocopies of the original forms must meet the requirements described for use in submitting manual results.
• Results must be postmarked by the cut-off date displayed in the 2018 schedule and in the General Instructions for each event.
• Late results will not be processed and will be scored as zero as per CMS.
• AAB is not responsible for results lost or delayed 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.  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 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.  If submitting results online, enter comment and fax insert and/or method description to 713-781-5008. 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.

SECONDARY METHODS / INSTRUMENTATION

PT samples must be treated the same as patient testing. Testing proficiency samples by more than one test method or instrument during an event is not permitted by CMS, unless patients are also subjected to such testing.  Starting in 2015, AAB offers special events for secondary instruments called Instrument Comparison.  You can run and report the samples on your primary and secondary analyzers as you choose.  We will analyze the data and provide you with group statistics for each analyzer and a correlation analysis for your primary and secondary analyzers.  These program events ship after the scheduled PT event for the analyzers.

CMS SCORING INSTRUCTIONS

All scores for CLIA regulated analytes are automatically sent to CMS and State Agencies. Results are also sent to COLA and the CAP for participants that supply a COLA or LAP 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 a 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.

Please follow all directions in filling out your reporting form completely. Once a report is graded, CMS does not allow for corrections due to participant’s clerical and/or omission errors.

If you are unable to participate for a proficiency testing event, you must notify us in writing in advance of the event close. A CLIA requirement for excused non-participation is that patient testing not be performed during the time frame of the event. Therefore your statement of intent not to participate must include an attestation that patient testing is not being performed at the time of the event, the reason for not participating in a proficiency testing and event when or if patient testing is expected to resume.  This excused non-participation can only be granted once within a reporting year provided you participated in the two prior testing events..        

If the non-testing is permanent or has no anticipated resumption, then you will receive a code of “Dc” indicating to CMS or your CLIA deemed authority that you are no longer performing this test.  You must indicate that you are discontinuing testing to receive a “Dc”.

If you anticipate resumption of testing by the next scheduled testing event, and if you meet the CLIA requirement of participation in the two prior events, you will receive a code of “Er” or exclusion requested. Please be aware, that a code of “Er” is subject to review by CMS or your CLIA deemed authority. We are required to abide by their decision and will remove the “Er” and convert your report to “NR” with a score of 0 if they feel your reason for non-participation is inadequate.

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.

CORRECTIVE ACTION

If the evaluation of your results indicates that corrective action is necessary, the Corrective Action Forms on the back section of this 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.

Remember that ungraded samples require review.  You must determine that you have met the CMS requirement to demonstrate the accuracy of your method.  If your review indicates you may have an accuracy problem, you must complete a corrective action just as if you were flagged for a miss.

ADDRESS CHANGES

Address changes must be received in writing by either fax, email, or mail on institutional letterhead. Notice must be received 21 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 28 days prior to the shipping date in order to receive a credit or refund on a future shipment. Late enrollments received within the 28 days prior to the shipment waive the cancellation policy and no credit will be issued. The registration fee is nonrefundable.