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Wisconsin State Laboratory of Hygiene

Tag: CLIA

WSLH PT Blog

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Important CLIA Changes to Proficiency Testing Requirements

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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

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Even A PT Provider May Experience An Audit

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What policies and processes are in place in your laboratory? In preparation for a laboratory inspection, this is the question you have at the forefront of your mind. We also have this question at the forefront of our minds too, but for different intentions and outcomes. A proficiency testing provider may experience a routine audit, as well as annual reviews of accepted analytes conducted by an accreditation agency, such as those conducted by the College of American Pathologists (CAP). The purpose of a proficiency testing audit is to provide you with the best experience when it comes to participating in our proficiency testing services. These processes of review and approval assure that you can use our proficiency testing services alongside your accreditation agency. In this article, we share with you an overview of the auditing process, and how it impacts you, the clinical laboratory.

An Inside Look at a PT provider

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are today’s standards for compliance and accreditation. Following the passage of CLIA ’88, laboratories that are reporting clinical results are mandated by law to attain CLIA certification with CMS. All CLIA-certified labs are also required to perform proficiency testing on regulated analytes with any CMS-approved proficiency testing provider.  Accreditation agencies are approved to act on behalf of CMS as an accrediting body. In response, the College of American Pathologists, developed a routine process as an accreditation agency to accept PT providers. This process assures that any CAP-accredited laboratory may enroll with any PT provider that meets CAP’s requirements regarding the acceptability of materials, scoring processes, and transmission of data. Today, when CAP-accredited laboratories are choosing a PT provider, they are determining if the PT provider and the analytes they need are accepted by CAP.

In order for WSLH Proficiency Testing to be a CAP-accepted PT provider, CAP representatives audit WSLH PT services every 3 years. During the auditing process, WSLH PT shares data with CAP from laboratories that choose CAP for accreditation. The following are the kinds of questions WSLH PT answers in a CAP audit:

  1. Are laboratories getting the information they need?
  2. Is the information presented in such a way that is easy to understand?
  3. Does the PT provider maintain consistency in how their technical coordinators evaluate data?

CAP representatives conclude the audit by visiting our office at the Wisconsin State Lab of Hygiene in Madison, Wisconsin. This day-long visit includes a shared review and discussion of key findings in data. Review and discussion of data offer insights into issues that laboratories may be encountering throughout the proficiency testing process.

All regulated analytes that CAP-accredited laboratories select from a PT provider must pass through an annual approval process to be CAP-accepted. If an analyte is CAP-accepted, then CAP will accept the score transmission of a CAP-accredited laboratory from the PT provider. Every year PT providers have the opportunity to apply for CAP acceptance for an analyte by filling out a form and submitting it by July for potential approval the following year. At the very minimum, PT providers must have 20 data points for three events in a row for quantitative analytes. For qualitative analytes, PT providers need 10 data points for three events in a row. Beyond the review of grading data, there are other criteria that CAP uses in determining the acceptability of regulated analytes. The other information that CAP requests from PT providers include, but are not limited to:

  1. Instrumentation, methods used, and number of participants
  2. Participant summary data for events
  3. Number of challenges and shipments per year
  4. Supporting documentation for analyte specifications and event data
  5. A statement that all material vendors comply with specified product manufacturing standards

Not all regulated analytes offered by PT providers are approved by CAP; so, laboratories that want to use their materials to meet CAP’s accreditation requirements must first check with the appropriate PT providers. If you review WSLH Proficiency Testing’s clinical product catalog, you will see that any analytes that are not accepted by CAP are noted with an asterisk (*). When CAP-accredited laboratories approach WSLH PT to enroll, they know which analytes will meet their regulations with the CAP Laboratory Accreditation Program.

Routine audits and annual analyte acceptance conducted by CAP assure that we can serve and provide options to CAP-accredited laboratories. Aligning our services and processes with the CAP Laboratory Accreditation Program not only benefits CAP-accredited laboratories but all clinical laboratories that enroll with WSLH Proficiency Testing. Whether or not CAP is your accreditation agency, the findings we review in a CAP audit help us assure that our materials, from general instructions to evaluation reports and policies, are accurate, clear, and concise for all laboratories.  This inside look into our partnership with CAP provides some insight into how we pursue collaboration, usability, and continual development to lay a solid foundation for laboratory improvement.

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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

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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.

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WSLH PT Blog

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Decentralized Testing: Effect on the future of laboratories

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Laboratory professionals are seeing more and more testing moving away from the central lab. The tests might be at bedside, in the phlebotomy station, in radiology, the emergency room, ICU, and even at home. These tests are being performed by nurses, clinicians, and medical associates. Additionally, medical professionals are sending more complex testing that does not require rapid turnaround time to reference laboratories. 

What does that mean for the average hospital or clinic laboratory? What is our role as professional laboratorians in this changing environment? What are the advantages and disadvantages of this exodus of testing from the main lab?

Point-Of-Care Testing (POCT) has enabled rapid results to be obtained while remaining with or near the actual patient. The advantages of this proximity of processing tests to the patient are apparent in the ability to administer insulin 

or other life-saving medicines within moments clearly improving patient outcomes. In the case of radiology, another advantage is efficient workflow as a technician is able to evaluate the safety of administering contrast media through sampling creatinine (kidney function) levels. Obviously, these advantages are significant when it comes to patient outcomes, but there are risks as well.

POCT, from the individuals who are asked to conduct the tests to the test quality itself, comes with a number of concerns that are exacerbated by the increased proliferation of such tests. The greatest risk is the fact that you are placing testing in the hands of individuals who have not been trained in understanding the importance of quality control and in recognizing poor results. Therefore POCT is often considered the lowest element on their patient care list. My sister has lived this experience. In her 40 years as a registered nurse, she says, her focus was patient comfort. While testing was something that had to be done, there were far more immediate concerns that had to be addressed. An excellent educational foundation sets up individuals for success. Given that the education of laboratory professionals gives primary focus to the study of analytical procedures, testing done in a core laboratory lends to more reliable, quality patient testing.

There are certainly benefits and risks to weigh in medical professional settings when deciding to outsource testing from the core laboratory. This not only includes POCT but sending tests to reference laboratories. Weighing delays created by sample transport for referral testing against patient outcomes must be a consideration since test results drive the majority of medical decisions. Norman Moore, PhD, director of scientific affairs for infectious diseases at Alere Inc. says that, “the main advantage is that outsourcing usually saves cost per test. However, we are finding that the cost savings on a test level are not balanced by the cost on a patient level in most instances.” Often clinics and hospitals may decide to outsource given that a referral lab can process many tests at a time versus at the pace of the technician or technicians available to process tests one-by-one in house. The ability for referral laboratories to process large batches of testing samples is often also seen as a way to address laboratory staffing shortages. Dr. Moore adds that outsourcing for the purpose of cost-saving is not very advantageous for patient care, given that referral testing delays access to results which, in turn, delays the healthcare provider’s ability to provide a timely diagnosis for the patient.

During the winter time, when the spread of respiratory infections are at their peak, it is important to diagnose and treat early. Furthermore, this need for a quick testing response is more acute in emergency room settings to address emergent patient needs. Outsourcing, especially in context of the growing availability of more samples that can process multiple tests at once, is not sustainable in the long-run, regarding budgets and, ultimately, patient care. It seems that keeping testing in-house, while also addressing laboratory staffing shortages that put a strain on providing timely, accurate patient testing brings us back to the question of Point-Of-Care Testing to help alleviate challenges.

POCT is a proven approach for providing a faster turnaround time of laboratory results. What must be addressed now, as companies continue to improve POCT equipment, is how hospitals and clinics can assure best practices in POCT. I would encourage laboratories to actively engage in training, quality control and proficiency testing for the point of care testing areas. Last year, AACC released a guideline that can help administrators and lab leadership define POCT performance in their facilities. The key questions that they ask are:

  • What is the value of an interdisciplinary committee to oversee POCT?
  • Does education improve POCT performance?
  • What is the optimal staffing model for POCT?
  • Do proficiency testing (PT)/external quality assessment (EQA) programs improve POCT performance and patient outcomes?
  • Does data management improve POCT outcomes?
  • How should staff select POCT devices?
  • How does POCT improve process?

I would highly recommend that facilities use this guideline to not only help define their current POCT performance but to help develop best practice in POCT.

Several years ago, the AACC released an article aimed to help facilities improve POCT compliance through preparing staff for routine inspection. If nurse leadership and other medical staff responsible for POCT know what questions inspectors may ask and what staff can anticipate, the work towards the standardization of accurate POCT can start to become more integrated among all staff involved. In other words, preparing for a POCT inspection can serve as a starting point for staff to start defining POCT performance and to start implementing best practices in POCT.

In addition, testing across multiple platforms should occur to prevent discrepancies between in-lab testing and POCT. I would also caution that the laboratory evaluate testing to remain in house vs. sent out based on patient critical need. If facilities intend to rely on referral testing, the referring laboratory must ascertain and have available the credentialing of the reference laboratory such as the CLIA and/or CAP certificate.

Point-Of-Care Testing is here to stay. Outsourcing lab work is a strategy that isn’t going anywhere. These facts highlight the importance taking a closer look at our current practices outside of the core laboratory and weighing them against our patient care outcomes, especially if we are approaching our questions from a cost-benefit analytical framework. Professional organizations such as the AACC have provided the latest resources to help hospital and clinic staff to improve POCT best practices and assure POCT compliance.

Take advantage of those resources and keep an eye on helpful articles from proficiency testing providers and regulatory agencies for helpful tips and guidelines to tease out the more complex side of planning, organizing, and coordinating POCT and referral testing. Core laboratories are encouraged to partner with nursing staff and other medical personnel to create training infrastructure on POCT analysis. Laboratory staff can also help implement a routine, internal audit of POCT practices that is POCT compliant with regulatory agencies, which in turn, helps everyone involved be inspection ready.

Reference:  The Shift to Point of Care Testing: In Clinical Chemistry Q&A, lab industry leaders look at impact of technology, reimbursement, other factors in move from hospital-based settings.
Date: NOV.12.2015  // Source: CLN Stat

WSLH PT Blog

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Who’s who of laboratory regulations

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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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