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WSLH Proficiency Testing

Wisconsin State Laboratory of Hygiene

Tag: CAP

WSLH PT Blog

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Even A PT Provider May Experience An Audit

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.

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

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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