Thank you for submitting your proficiency testing questions. Dear API Abby is here with answers! The American Proficiency Institute (API) is pleased to share its technical expertise on all things proficiency testing. API, a global leader in proficiency testing programs, is dedicated to improving the accuracy and efficiency of clinical laboratory testing. Known for its constant innovation in the field, API offers technical expertise and checklists to help its laboratory customers become more proficient. Now let’s get to your questions!
Dear API Abby:
The laboratory world has always been my happy place, but writing skills, not so much. As much as I try to avoid them, typographical errors happen when submitting proficiency testing results. I really don’t mean to, but sometimes I type in the wrong number. What’s my penalty for these mistakes? Is there a corrective action that is assigned specifically for typographical errors?
Oops I Did It Again
Dear Oops:
Reporting results is an essential component of laboratory testing. While it might be rare for you to type patient results, there are times when this may be necessary. Transcription errors could go unnoticed in the laboratory and have serious consequences. That is why proficiency testing issues due to transcription errors are treated by regulators the same as other proficiency testing failures. Even little errors can create major concerns; so as laboratorians, we need to take them quite seriously.
As with any failure, you should determine its root cause. All laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) must have corrective action policies and procedures in place to ensure accurate and reliable patient results and reports. Checking those policies specific to your laboratory would be a good place to start.
When it is determined that a transcription or clerical error occurred, additional thought should go into the reason why. Was the employee rushing? Are they able to clearly read the instrument print out or interpret the test? Is the computer and work environment set up sufficiently? Is there a policy to proof manual entry? After questions such as these have been answered, you should determine what can be done to prevent this error from reoccurring. Retraining personnel on your laboratory’s policies and procedures, how to read the instrument print out, or interpretation of results may be necessary. Perhaps an employee may be due for an eye examination. This should be supported to ensure they are able to see computer screens and print texts clearly. Remember too that manual entry should be proofed before releasing results.
Even a small “oops” can have big consequences — for patients, for the laboratory, and for you. We applaud you for acknowledging the problem and encourage you to take action to prevent it from occurring again.
Dear API Abby:
I work in the microbiology laboratory of a hospital where my specialty is bacteriology. The last time we added a new method in bacteriology, we knew we wanted to do proficiency testing for it. But do we have to add proficiency testing specifically for each new method we add?
Curious Staph Member
Dear Curious:
Not necessarily, but there are several factors to consider. Proficiency testing for microbiology is regulated according to subspecialties: bacteriology, mycobacteriology, mycology, parasitology, and virology. Within each subspecialty, proficiency testing is not necessarily required for each specific method or technology used, but there are different types of testing that should be included as well as other regulatory requirements to keep in mind.
According to CLIA, a laboratory must perform a minimum of five challenges, three times per year for each of its microbiology subspecialties. Best practice is to spread the challenges over multiple procedures and methods within each subspecialty. For bacteriology, you should include methods for identification, antigen detection, toxin detection, gram stain, and susceptibility testing. If your laboratory has a large test menu, you will likely exceed the minimum five challenges per subspecialty. You should also review both your laboratory accreditation and state requirements as they may mandate additional proficiency testing for specific procedures.
Although it may seem like a lot of “proficiency testing,” you are actually meeting other requirements too. Proficiency testing may serve as the “blind testing” element required for CLIA personnel competency documentation as listed in §493.1413(b)(8) and §493.1451(b)(8). Proficiency testing also helps your laboratory demonstrate reliability and accuracy on all tests performed within the laboratory, as required in §493.1236.
Each of these requirements contributes to ensuring the overall quality of patient testing.
Dear API Abby:
I am responsible for reporting our microbiology proficiency testing results, and here is my question: For culture samples, why are there so many options when reporting results for the organism recovered? Is it totally up to me how general or specific my answer is, or is there some guidance I should be following?
A Person of Culture
Dear Culture:
For better or worse, the guidance is the same for all proficiency testing: treat the sample as you would a patient sample. This includes reporting. When testing and reporting a culture for a patient, sometimes you arrive at a species identification, and sometimes a genus or category is where your testing stops. Your protocols for testing and reporting different organisms are determined by your laboratory director and may depend on factors such as the sample source or patient history. That could be why you see reporting options not used in your laboratory.
Please note that CLIA requires that organisms reported for proficiency testing results are at the same taxonomy level as used for patient results, and the updated language in the July 11, 2022, CLIA final rule makes that clearer and easier to enforce now. So if you are looking at identification options for a proficiency sample and would report that patient result to the species level, do the same for the proficiency testing result. This does not mean all samples must have the same level of specificity, if that is what you are concerned about. Follow your laboratory procedure and choose the response that is closest to what you would report for a patient. If you have reviewed the list carefully and there is no match, your proficiency provider likely allows you to enter a description that would match what is used in your laboratory.
Dear API Abby:
I know there was a CLIA change related to prothrombin time, but I’m really not clear on all of the rules and how they will impact my lab. Would you clarify?
Rules Not Clotting Fast Enough
Dear Clotting:
Glad to lend a hand. First, remember that proficiency test results must be reported in the same manner as patient test results. For prothrombin time, we know that patient results may be reported in seconds or as an international normalized ratio (INR). Prior to the CLIA updates effective in 2025, only prothrombin time in seconds was a regulated analyte. CLIA now includes both prothrombin time in seconds and as INR. Therefore, if you report patient results as seconds, INR, or both, you must report your proficiency testing results the same way: as seconds, INR, or both. You probably have already been doing this.
Starting in 2025, if proficiency testing results are reported as INR, they will be evaluated according to regulatory criteria. The criteria for acceptable performance of prothrombin time, whether in seconds or INR, is a target of ±15 percent.
If a laboratory reports both prothrombin time in seconds and as INR, both will be evaluated according to regulatory criteria. However, only one score will be transmitted and monitored by the Centers for Medicare & Medicaid Services (CMS), and the agency has clarified they prefer the INR score, if available.
Dear API Abby:
Must I perform proficiency testing if my laboratory is only conducting waived testing? What are the rules on this?
Simon Says
Dear Simon:
CLIA does not require any laboratory to perform proficiency testing for waived tests, especially laboratories like yours, with a Certificate of Waiver or Certificate for Provider-Performed Microscopy. However, recent CLIA changes did mention proficiency testing for waived tests, so we understand your query. That change only affects moderate or high complexity laboratories. Keep reading for a question about that from another laboratory colleague at a different type of laboratory.
So for your waived testing laboratory, all that is required by CLIA is that you follow manufacturers’ instructions. But you should also follow up with your state or accrediting agency as they may have additional rules that could require proficiency testing for some waived tests.
And even if you, Simon, won’t say it, we will: proficiency testing is an essential tool for helping laboratories get the right results – no matter the complexity of testing. Proficiency testing provides an independent and external assessment in how tests are conducted, and helps laboratories manage risk. Proficiency test results are used to verify methods and equipment, and are excellent sources of continuous education for your laboratory staff. Even if it is not required for your laboratory, you may want to look deeper into how proficiency testing will ultimately benefit you.
Dear API Abby:
Can you help settle an argument in our laboratory? We have a moderate/high complexity laboratory, and we have point-of-care testing under the same CLIA number. But in point of care, we are only performing waived testing! Since the point-of-care testing is waived, I don’t think the CLIA rules about how to conduct proficiency testing apply to that department. Our new laboratory manager said that is not true.
Don’t Worry; It’s Waived
Dear Waived:
I’m sorry; I have to side with your new manager here. The recent CLIA change addresses this situation. The rule makes it clear that moderate or high complexity laboratories must treat all their proficiency testing the same, even proficiency testing for waived tests. This means you cannot test samples for waived tests more than once no matter how many staff you have performing those tests. You cannot assign your most experienced staff to perform all the proficiency testing, and you cannot discuss the results with other laboratories until after the due date for submitting results. All the usual rules about proficiency testing apply to any proficiency testing moderate or high complexity laboratories perform. The “waived” status of the test doesn’t waive the CLIA requirements about how to handle proficiency testing.
Kudos to your laboratory for performing proficiency testing on your waived tests! Even though that is not required by CLIA, proficiency testing participation helps to ensure reliable and accurate results.
