Frequently Asked Questions
Kit & Specimen Questions:
Where are the instructions?
General Instructions should be attached to the outside of the kit under the shipping label. Specific instructions are online in the Program Guide and in your account portal. After you sign into your account, click on either Chemistry or Nonchemistry, and then under Forms, click on the program module name to go to the result form page. At the top of each result form will be a list of Attachments & Links including specimen instructions, codes, and a printable worksheet.
When I opened my kit the specimens were warm/the ice pack was thawed. What should I do?
Upon receipt of the kit, refrigerate specimens until testing. The samples are validated to be stable during normal shipping conditions without ice packs. The ice pack is merely included to protect the samples against extreme temperatures during shipping. An ice pack will only remain frozen for about 12 – 18 hours, and is therefore expected to arrive thawed. If your samples arrived within the normal 2 day time frame from the shipping date, these specimens are suitable for testing and will not be replaced. If samples arrive outside the 2 day time period and are visibly degraded, or samples which should contain intact cells are grossly hemolyzed, please contact Technical Support as quickly as possible at 800.234.5315. Any dry sample and most liquid samples will still be fine. However, we will work with you and replace sensitive samples at no charge. We will replace samples only if you contact us before the published deadline to allow ample time for the replacements to be sent.
What do I do if the samples arrive broken?
What do I do if my DAT samples are hemolyzed?
If cells are present, wash the cells with saline and test according to your protocol. If no cells are present, contact AAB-MLE for replacement samples if available.
My diluent is missing for microbiology specimens. What should I do?
Do not delay testing for cultures. The sample swab may be moistened with enriched media broth or sterile saline and used directly to inoculate primary culture plates or media. Sterile saline may also be used for paddle dip kits such as Uricult.
Testing & Reporting Questions:
How long can I delay testing for Endocrinology 1 (SC specimens), program module 860?
Refrigerated Endocrinology1/fertility specimens should be tested within 48 hours of receipt. If you anticipate any delays in testing the SC samples, freeze them immediately.
What should I do if I am not reporting results for this testing event?
Either submit an Exclusion Request Form, or from your web portal result form page, click the blue comment button at the bottom left to indicate you are not submitting any results for that page. Include an explanation.
How should I run specimens in “control mode”, and why - if it’s supposed to be treated like a patient?
PT samples are not exactly the same as freshly collected patient samples. They are manufactured for stability, and are usually made from the same materials as your quality controls. In some cases, a modified procedure needs to be followed to obtain accurate results. Check your package insert or manual for instructions for proficiency or “survey” samples. This is especially important for hematology analyzers, as some machines will need to be “told” the specimen is a control or QC sample in order to process it correctly. This may be done by entering the sample ID in a certain way, or by opening an old control file on the computer screen. Your instrument manufacturer’s technical support reps can explain exactly how to test the specimen as a control.
How many times should I run the proficiency samples?
Only do the test once- just like you would on a patient. PT should only be repeated if your routine procedure would be to repeat a patient test with the same result, such as when “out of range” or “flagged” high or low results occur. Some abnormal results are to be expected, since the test has to be able to detect a range of normal and abnormal values. If there is an error code and no result, consult the package insert or manual to determine what the code means.
Should we report results for multiple instruments or multiple testing personnel?
No. Proficiency testing is an external assessment of your facility as a whole, therefore, only one set of results should be submitted for each account / CLIA ID. A good practice would be to assign proficiency testing to staff members on a rotating basis throughout the year, so the PT is not always performed by the same individuals. It does not matter to AAB-MLE which individual performs the proficiency test, as long as it’s someone who routinely performs your patient testing.
Which machine should be used to run the proficiency test?
If you have multiples of the same machine or method used for the same test, use the primary one for PT. If one of your methods is waived and one is non-waived, use the higher complexity, non-waived method for PT. If you are transitioning to a new machine or method during the PT event, use the one currently in use for patient testing. AFTER the results submission due date, the secondary method can be tested. Keep the secondary results in your AAB-MLE binder until your evaluation report is received, then do a self-assessment of the ungraded results.
Should we test each practitioner who performs microscopy or other testing?
No. PT should only be tested one time, by one practitioner/provider, like you would for a patient sample. A good practice would be to assign proficiency testing to different staff members on a rotating basis throughout the year. There should not be any comparison of results before the results submission deadline. After the PT due date, certain samples, such as PPM photos, may be saved and used later as internal competency challenges for other testing personnel. Proficiency testing can be one component of competency assessment, but competency assessment is an internal evaluation of each individual’s performance of the entire testing process, including the pre- and post- analytical phases. An annual employee competency assessment includes the testing of samples of known value, such as saved PT samples, as well as direct observation of work procedures, QC, maintenance checks, recording and reporting of results, plus a review of records, worksheets, and assessment of the person’s troubleshooting ability.
What if my results are less than or greater than my reportable values?
For quantitative results that fall outside of the reportable range or range of linearity, type the symbol to the left of the numerical value in the result field. Use < for less than, or > for greater than, followed by the number representing the lower or upper limit of your test. (Example: a result of less than 5.0 would be entered as <5.0) If instead of a number, your instrument displays symbols or words such as HI or LO, you must consult the operator’s manual to determine what the code means. (i.e., greater than__, less than__, etc.)
What should I do if my analyzer will not produce a result?
Check the AAB-MLE sample instructions and your package insert or procedure manual to make sure you followed the correct testing procedure. If no result can be obtained, leave it blank and submit a note of explanation in the comment field at the bottom of the online result form.
What if a result will not fit in the space provided on the result form?
First, make sure your units of measurement match the units on the AAB-MLE result form. If not, your test results MUST BE CONVERTED to the units on the form. If the number of digits is too large to fit in the spaces provided on the form, round the number off so it will fit. The decimal point on the form cannot be moved. Follow these guidelines for rounding numbers:
- If your answer ends in 1, 2, 3, or 4, round down. Decrease your value to the next number. For example, report 13.1 as 13; report 40.32 as 40.3.
- If your answer ends in 6, 7, 8, or 9, round up. Increase your value to the next number. For example, report 13.8 as 14; report 20.47 as 20.5.
- If your answer ends in 5, round to make it even. Here’s how: Look at the digit immediately to the left of the 5. If that digit is even, drop the 5. If that digit is odd, increase your value to the next number. For example, report 13.5 as 14; report 18.45 as 18.4.
What codes do I use for antibiotics not listed?
Simply type the information into the comments field. Make sure the antibiotic is appropriate for the organism and source. CMS rules require us to score antimicrobials as incorrect if not listed as appropriate for the intended organism and source in the current edition of CLSI Performance Standards for Antimicrobial Susceptibility Testing (M100). Antimicrobials that are not added to the CLSI guidelines will not be added to our list.
Explain Microbiology Extent Testing
This refers to how specifically your laboratory identifies organisms in the culture. Report only one extent type for all of your cultures. This will be the highest extent to which you will result.
Extent 0 = Culture source not performed (eg, Leave the result field blank)
Extent 1 = Gram Stain (eg, Gram positive cocci)
Extent 2 = Presumptive ID (eg, Presumptive gram positive organism)
Extent 3 = Genus (eg, Staphylococcus species)
Extent 4 = Species (eg, Staphylococcus aureus)
Extent 5 = Anaerobes
Evaluation and Troubleshooting Questions:
How do I view my reports online?
Login to your online account using your account number and password used to submit results. Your Dashboard will display the events you reported. Click on the checkmark under the Results column to see your results and scores. Click on the blue “Print Results” link at the top left to create a printable copy of the report.
What do the #, ?, *, @, Dc, Er, Wv and ND symbols mean on my graded report?
A legend is included at the bottom of your results page which explains these symbols. The table below expands on the explanations.
|This result was not graded due to an insufficient number of method peer respondents. No appropriate default grouping was available and you received a default score of 100 for this specimen. The listed range should provide a reasonable guide to your performance. However, exercise caution when evaluating your result. You need to review this result to make sure that you can defend your response as accurate. Generally, if your result is within the given acceptable range, at a minimum a documented QA/QC review is required. Typical additional studies include split patient and known value material testing. Contact your Surveyor from your CLIA deemed regulatory body to determine if any other action is required. If you are outside the given acceptable range, you either need to justify why this range is not appropriate or treat this as a miss requiring corrective action.
|This score may not truly evaluate performance for this specimen which was not graded because of a lack of participant consensus. You have received a default score of 100 for this sample because our statistical checks indicated your group was not valid. You need to review this result to make sure that you can defend your response as accurate. Generally, if your result is within the given acceptable range, at a minimum a documented QA/QC review is required. Typical additional studies include split patient and know value material testing. Contact your Surveyor from your CLIA deemed regulatory body to determine if any other action is required. If you are outside the given acceptable range, you either need to justify why this range is not appropriate or treat this as a miss requiring corrective action.
|Out of range or incorrect response. This is a miss. Corrective action is required on your part.
|Unable to report due to technical difficulty. You were unable to obtain results and notified us that you had difficulties in performing testing on the sample. This is a null response and does not count for or against your grade.
|Dc is short for discontinued. You received this on your Cumulative report score for a regulated analyte because you have notified us during the testing event that you are no longer performing this test in your laboratory.
|Er is short for exclusion requested. You received this on your Cumulative report score for a regulated analyte because you have notified us during the testing event that: a) you are temporarily unable to report this analyte and provided us with a reason: b) you are not performing patient testing during the PT event and are referring specimens out for testing and: c) you participated in the two prior events.
|Wv is short for waived method. You received this on your Cumulative report score for a regulated analyte because you previously reported a non-waived method and now reported a waived method for this event.
|ND is short for Natural Disaster. You received this on your Cumulative report score for a regulated analyte because you notified us that you were unable to participate in this PT event due to a natural disaster event affecting your lab.
Do I need to send my results to CMS?
If you provide us with your CLIA ID number, we will electronically transmit your results to the appropriate state and federal agencies. If you are performing testing for medical use, you probably fall under the CLIA regulations and need to have your PT scores submitted to CMS.
What should you do when a state official says that their file shows a score of “0” for a waived test yet you received a passing grade from AAB-MLE?
If there are any questions as to your actual performance, then you should be able to show the state a copy of your results for the analyte and event in question. That should be sufficient to resolve any concerns. Please contact us at AAB Technical Support if you have further questions.
I know the reason we failed, but how should I document it?
Print a copy of the AAB-MLE Corrective Action Guide or use your own form. File the completed and signed form with the evaluation report for future reference.
Do I need to send corrective action forms to AAB-MLE?
No. Keep all corrective action and troubleshooting documentation, including repeat test results, in your AAB-MLE binder with your evaluation. You will need to have this information available for your next inspection.
What should I do if I missed the result deadline?
CMS does not allow PT programs to accept results for grading after the due date. You should do a “self-evaluation” or “self-grading” to see if your results would have been acceptable if submitted on time. Perform the testing, if you haven’t already, and record the results on paper. The Participant Summary will be available online approximately 2 weeks after the Target Evaluation date printed on the shipping calendar. You will need to use the Participant Summary data to compare your results to other labs using your test method. Print the relevant pages and keep this documentation for future reference. Review the Corrective Action Guide found on the Forms page, and perform troubleshooting as necessary for results that are not acceptable.
Did anyone else have the same problem with this test?
Everyone gets the same lot # of specimens, so if the test was graded, and your kit was received on time and stored at the proper temperature, then the specimens were OK. If a specimen is bad, more than one analyte will probably be affected. PT programs are required to have at least 80% consensus (agreement) in order to grade most tests, so that means at least 80% of the labs passed that challenge. The Participant Summary details the number of labs that submitted results for each test. Refer to the AAB-MLE Corrective Action Guide, found on the Forms page.
Influenza antigen results were negative but they should have been positive.
Was the PT specimen tested like a nasal washing or aspirate, as directed in the instructions? If a swab was used to sample the specimen, the correct procedure was not followed. The specimen needs to be tested “straight”, not extracted from a swab, which does not pick up enough of the antigen. Check your package insert or contact the kit manufacturer for instructions, then repeat the test using the correct procedure.
We had a PT failure but our controls are fine. What should I do?
Refer to the AAB-MLE Corrective Action Guide, found on the Forms page. A few additional tips:
- Check original printouts for clerical errors, data entry errors, or specimen mix-ups.
- Check your method printed on your evaluation report, to make sure it was recorded correctly and that you were graded against the correct comparison group.
- Retest the sample. If the original samples were not saved, you can purchase replacements. Verify that the specimen number is correct, that the AAB-MLE instructions are followed, and any special procedural instructions in the package insert of your kit are followed exactly.
- Check your QC records for the time period before and during the proficiency testing event. Find out exactly where the control values been falling within the range, and look for a similar pattern to what you see on your PT report. Even though controls have always been “in”, they might have all been running on the high or low side of the mean. Note the lot number and expiration date of the reagents that were used when you did your proficiency test.
- Call the instrument/kit manufacturer for technical support. They may be aware of a problem with a certain lot, or you may need to recalibrate or have a service technician check out your machine in person.
Will AAB-MLE send our records to the CAP, COLA, or state/CLIA/CMS?
Yes. You must provide the CLIA number assigned to your facility. The CLIA number is the unique 10-character alpha-numeric code on your CLIA certificate that is utilized by your state and CMS to identify and track your laboratory. If you have an accrediting body such as CAP, COLA, or New York State, we must have the number assigned to your lab by that body to transmit your PT enrollment and scores to them.