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WSLH Proficiency Testing

Wisconsin State Laboratory of Hygiene

Tag: clinical proficiency testing

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Important CLIA Changes to Proficiency Testing Requirements

The Centers for Medicare & Medicaid Services (CMS) published their final rule on July 2022 including Proficiency Testing (PT) revisions. PT revisions will go into effect January 1, 2025 and will include analytes that will be CMS regulated along with revised grading criteria for existing analytes. Please refer to this 2025 CLIA changes document for more information, including the effective date, and also the implementation date of the CMS final rule. 

Most of the modules WSLH PT offers already meet these requirements. Where possible, WSLH PT will reassign laboratories using a non-waived method enrolled in a 3-sample PT module to a 5-sample PT module. Reassignments will be reflected on 2025 Enrollment Quotes sent out in September 2024. The tables below list new CMS regulated analytes with their corresponding modules and revised scoring criteria.

Further changes will be communicated closer to the implementation date of January 1, 2025. If you have any questions about the new requirements, please contact WSLH PT at 800-462-5261 or ptservice@slh.wisc.edu.

To view the new CMS-regulated analytes, revised scoring criteria for currently regulated analytes,
and microbiology changes, please visit our webpage: 
CLIA and Proficiency Testing Changes – WSLH Proficiency Testing (wslhpt.org)

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Steering Clear: Avoiding common PT errors

Words like “failure” can be scary. In the world of medical laboratory science, the word failure takes on a whole new level of serious, real-life consequences, should failures occur during any kind of testing. Thankfully, when it comes to investigating proficiency testing (PT) failures, there is an abundance of information available online to help clinical laboratories develop corrective and preventative actions to avoid common pt errors.

Pre-examination, examination, and reporting checklists that are generated in root cause analysis, like this handy one from Lablogatory, can serve as a “launch pad” for the development of guidelines to take corrective action. Clinical laboratories use root cause analysis to identify, define, and resolve a core issue, so that resulting errors or failures cease in future proficiency testing efforts. This systematic process of analysis can help us ask the questions that give us the full story of why a failure occurred.

Much like journalists, we laboratory professionals ask “who, what, when, where, and why” questions to help us investigate. In the vein of root-cause analysis, WSLH Proficiency Testing has provided detailed scenarios of common PT failures exemplified throughout the proficiency testing process, from pre-examination to reporting. The review of detailed scenarios in specific proficiency testing programs, which are couched in real-world, empirical evidence can aid clinical lab staff in the development of strategies from investigation to action.

Let’s visit the world of hematology proficiency testing for our first scenario. Since hematology proficiency testing (PT) samples are manufactured material, most PT samples for hematology have to be tested in the quality control (QC) mode instead of patient mode to recover the correct values. In one particular instance, a laboratory did not use the barcode provided on the PT sample. Instead, the lab applied their own barcode which triggered the sample to be tested in patient mode, leading to failures on the differential parameters. The barcode provided by the PT provider would have triggered the sample to be tested in the correct QC mode; and, the lab would have recovered the correct values.

This is a common sample handling error seen in hematology PT and is very avoidable. Many times, labs are instructed to perform remedial action as required by their accreditation agency as a result of this handling error. Sometimes it is helpful to see an example, in order to be able to identify the causes that result in a lab testing in the wrong mode. 

Please see the snippet of a 2020 HemeReg1 report, for example.

Here are some key steps and resources to consider in avoiding this common error:

  • Always read the proficiency testing sample handling instructions that come with your PT kit. In this particular instance, there were specific handling instructions provided for each type of hematology instrument explaining how to test the PT samples in QC mode. If you do not understand the handling instructions, call your PT provider for clarification.
  • Your hematology instrument manufacturer can also be a resource to assist you with testing your PT samples in the mode specified by your PT sample handling instructions.
  • The CLIA Proficiency Testing and PT Referral booklet (pg. 7) provides some helpful guidance explaining that, although you are required to test PT samples like you would patient samples, sometimes PT samples require special treatment.

In the world of Blood Bank (Immunohematology) proficiency testing, the need for labs to seek out remedial testing most often stems from compatibility failures. The Blood Bank Comprehensive program includes a set of five samples (unknowns), plus a donor cell for compatibility testing. When reporting online, it is important to list the compatibility testing method used for each sample. Select if an immediate spin or anti-human globulin (AHG) method was used, so that the type of testing matches the situation and your lab protocol. Some labs use a combination of immediate spin (negative screen) and AHG (positive screen) testing. Others may use AHG for all compatibility testing samples regardless of the screen result. Let’s take a look at these two common errors and helpful hints we can employ to sidestep these failures in the future: 

  • If your lab performs anti-human globulin (AHG) crossmatches, you must perform them on the PT survey when warranted (i.e., when a sample has a positive antibody screen). Do not report an immediate spin crossmatch interpretation as your final result on samples that warrant an AHG crossmatch (has a positive screen) or you risk failure.
  • Labs that routinely perform both immediate spin and AHG testing on all samples should report the serologic interpretation as “Not compatible” if either test is positive.
  • Per CMS, labs using antiglobulin crossmatch methods (automated or manual) that employ a technology only designed to detect incompatibilities due to IgG antibodies, must also use an immediate spin crossmatch to detect incompatibilities due to IgM antibodies (i.e., ABO incompatibilities). 

(Please see the snippet of a 2020 BloodBank3 report, for example.)

Immunohematology proficiency testing samples have a shorter shelf life, as they are manufactured to simulate whole blood. When the PT event closes, these samples expire. Therefore, if a lab needs to troubleshoot a failure, the age or expiration of the samples should be noted with follow-up documentation.  

The oversight of any step, however small, can create major setbacks in proficiency testing. One such oversight commonly made among clinical laboratories is the failure to identify a PT sample—in other words, to treat a proficiency testing sample like a patient sample. Recently, one of our proficiency testing program coordinators received a call from a lab requesting replacement of Blood Gas proficiency testing samples. Upon receiving more context from the lab supervisor, the WSLH PT program coordinator learned that the lab had given the sample set and instructions to the selected Point-Of-Care analyst who was to run proficiency testing for the current event. The analyst ran all five samples without inputting the sample ID into the instrument (i-STAT). They then returned their printouts to the supervisor for submission to WSLH PT. When questioned, they reported that the samples had been run “in order”, but had no proof; so, those results could not be submitted for the event. Subsequently, the supervisor had to call WSLH PT to order (and pay for) a replacement sample set to retest with the sample IDs before they could complete the event.

These detailed, real-world instances that WSLH Proficiency Testing program coordinators have provided aim to assist clinical lab staff in the development of their own strategies, which are situated in root cause analysis. Investigation, planning, and communication with all participating staff can help clinical laboratories get to the root cause of common problems, and to make sure such errors do not happen again. WSLH Proficiency Testing offers a corrective action form online for clinical laboratories to use as a tool or guideline for investigating PT failures. Please refer to our Resource page where you can find this form among other helpful resources for clinical laboratories conducting PT. Utilizing resources and learning from scenarios such as these can aid laboratory professionals in initiating conversations, investigations, and trainings with staff so that common PT failures may be avoided in the future.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Feeling Thankful For The Lessons Learned

5 reasons we’re grateful for those teachable moments of the pandemic 

1. Assuring Laboratory Accuracy
When the pandemic hit, CMS determined that it would be business as usual. Yes, we are thankful for that. It meant more work for us creating different staffing models to do the same work. The reward was knowing that laboratory accuracy was still being measured. We are also thankful for the many lessons learned during this time too.

2. Lessons From The Supply Chain
We learned that the current method of procurement did not stand up to increased demand. In spite of the manufacturer’s ramping up production of needed items, raw materials were unavailable. Even when items could be produced, transportation bottlenecks confounded our ability to get what was needed. Distribution was sporadic; and, some facilities had much and others not enough. There was no system of sharing. We now know that we need better communication as well as a directory of alternate sources. We are thankful that these challenges are being talked about and addressed.

3. Staying Safe At Work
Offices in clinical and other healthcare settings got creative with how they worked, to allow staff and their families to shelter-in-place and quarantine safely. We put our public health values into practice, serving as models for how other workplaces across industries might implement public health measures in response to COVID-19. In particular, WSLH Proficiency Testing was able to shift to a blend of in-office and remote work, so that we could maintain proper social distancing and mitigate the possibility of transmission with less people in the office. We discovered that we could still effectively provide technical troubleshooting and responsive customer service from the safety of our homes. We continue to be grateful for this flexibility.

We learned that biosafety protocols needed review or revision. Clinical laboratories had to discover ways to stay safe, while managing a great influx of tests to process and analyze. From a biosafety standpoint, clinical laboratories had to take pause and assess biosafety challenges, such as how suspected or confirmed SARS-CoV-2 samples should be handled and transported. Clinical labs also had to practice greater care in practicing other testing procedures that are sure not to develop aerosols or droplets in unintentional or undetected ways. We are grateful for the published guidance and resources available for clinical labs to address biosafety challenges.

4. Adapting To Emergent Telecommunication Needs
We also adapted to new telecommunication needs, and to the various tools and platforms that continue to help us stay connected. Across organizations, we are now seeing a successful blending of online teleconferencing and networking platforms with in-person interaction. We hope this hybridization of communication techniques will be furthered in ways to increase inclusivity and promote public health safety in the workplace. We are thankful for the opportunity to learn how to optimize our use of the tools, platforms, and strategies to address emergent workplace needs, both in and beyond the realm of internal and external communications.

5. Everyone Plays A Part In Public Health
Sometimes our lessons learned are difficult to process, especially when we are in the midst of a challenge and might not be able to see how we might move forward. We have and continue to be challenged by disinformation and distrust as the pandemic was politicized from the start. This politicization of the pandemic also, in turn, politicized public health measures that we know work. This has made implementation of a nationwide vaccine program challenging, among other public health measures that we did not foresee would be contested in the political arena. We learned we needed to ramp up our educational outreach and hold media-based organizations accountable for how information about the pandemic was and continues to be disseminated. We learned that we needed to educate the public not just in the face of a pandemic but always in preparation for the inevitable recurrence of new and puzzling infections.

We wish we did not have to learn some of these lessons through the course of a global pandemic; but, such monumental challenges throughout history have been teachable moments for all of us clinical laboratory professionals, the broader scientific community, and champions of public health. The scientific world has pulled together their time, talents, and resources to create new testing platforms, to advance epidemiological tracking, and, through research and diligent work, to develop more than one vaccine to protect healthcare workers and the general population. We are grateful for the individuals and organizations who continue to work at all levels of society to make a changes, at the institutional level, at the individual level, and at the interactional level. We are, most of all, thankful to our customers and laboratories nationwide for not giving up and working together to find a solution. We all have a part to play, and we are grateful for your contributions.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

On The Road Again: A Look at the World of Tradeshows

 

By Kristine Hansbery
Director of WSLH Proficiency Testing

Adapting to the new world of digital technology and virtual communication has presented both opportunities and barriers. The COVID-19 pandemic has necessarily pushed us further into the world of virtual communication which, in turn, has effected the way we do events and tradeshows. These events have always provided the ability to acquire much needed Continuing Education Units (CEUs), and wonderful opportunity to network with our peers.

 

Numerous vendors and show sponsors have recreated this important venue in a virtual setting for laboratory personnel as well as vendors promoting their product. There have been some successes and some, well, not so much. This article provides a closer look at this world of virtual events that have been rather hit or miss, and those perennial favorites of the past, and what makes them so special. We at WSLH Proficiency Testing hope this guide provides potential show attendees with the opportunity to explore new shows as well as make informed decisions regarding the expense and value of each venue.

There just is no way you can replace human contact with virtual events. Something must be said regarding the person-to-person networking that happens at each event. Capturing the attention of attendees at a virtual venue can be difficult given that the structure at in-person events encourages networking naturally. From the perspective of a vendor, the best virtual event by far for us was the Lab Director’s Summit, sponsored by MLO. This event actually created events that mimicked the real one-on-one conversations that would exist at a live event. They took it a further step by allowing vendors to present their product line as a 30-minute presentation to attendees in the following ways:

  1. Have one-on-one meetings with each and every attendee (like a dating event). The vendor has a 15-minute meeting with an attendee, a bell rings and then the next attendee arrives in the booth.
  2. Initiate meetings either set by the attendee or the vendor, in a polite nonintrusive manner.

While the best of the virtual world allows for greater connection and networking, we have all experienced the limitations with this format, technologically and socially. It’s important for our species to connect and see each other in-person. Plus, how much more eye-strain and zoom fatigue can we handle, given that much of our personal lives are online these days? While we hope we can return to real-life shows in 2021, let’s take a look at some of the top live events that we find rewarding and, let’s face it, just plain fun.

American Society of Clinical Laboratory Scientists (ASCLS) meetings
While each and every one of these ASCLS state-sponsored events are good, some stand out as particularly engaging.

ASCLS Minnesota takes place yearly at the Earle Brown Center, which captured the horse lover in me with old timey pictures of the largest horse in the world (at one time) as well as some race horse facts and other photos. The venue is very well attended by both laboratory professionals and vendors. The opportunities to network are plentiful. What a great show!

ASCLS Montana provides one of the most welcoming shows with beautiful scenery wherever you look.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up to receive your digest of clinical lab news, memes, and more:

WSLH PT Blog

Bringing you clinical lab features, news, and updates via the WSLH PT Blog! If you are interested in receiving an email digest of news along with curated staff picks from around the internet, sign up for WSLH PT’s monthly newsletter, The MedLab Retriever.

Who’s who of laboratory regulations

By Kristine Hansbery
Director of WSLH Proficiency Testing

I am perpetually surprised at how confusing the world of laboratory regulations can be; so, I decided to write a brief summary that gets down to the basics.

All laboratories at minimum must meet CMS requirements as stated in CLIA 88 and can be inspected by their state agency.

If laboratory chooses to do more the agencies listed above are the most common alternates selected.

Proficiency testing is separate from the regulatory agencies. CLIA mandates which laboratory tests require proficiency testing; however, your regulatory agent may require more.

Proficiency testing providers provide unknown samples and score performance of laboratories testing those samples. The scores are reported to CMS and any other regulatory agent the laboratory is signed up with.

A list of proficiency testing providers can be found here.

In summary:

  • Laboratories must comply with CLIA 88 regulations. Laboratories can be inspected by their state agency (CLIA office) or sign up with an alternate regulatory agent approved by CMS/CLIA
  • Laboratories performing testing that is not waived must sign up for proficiency testing and there are several choices.

For further information, visit our Resource page.

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