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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

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

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.

How We Cope During COVID-19

As we ring in the New Year, with hopes, goals, and challenges in mind, medical laboratory professionals continue to respond and adapt with inspiring tenacity to assure quality patient testing. Self-care has never been so important to minimize burnout and promote a more sustainable workplace. We hope what we share below encourages you to share with us how you and your team cope with stress through adaptive strategies like resource-sharing, self-care, and storytelling. Please share with us by replying by email at ptservice@slh.wisc.edu.

As we challenged assumptions about our own ability to adapt and learn new ways of working, we forged through some of the most difficult realities of our working life during the COVID-19 pandemic. Our individual and collective journeys as laboratory professionals have taught us lessons to help us adapt to difficult situations and conditions, or have taught us that a different career trajectory is possible, and needed, for our own well-being.

Should we decide that we might survive and thrive better in healthcare settings than in other workplace settings, finding healthy coping mechanisms has been integral to minimizing burnout and compassion fatigue, beyond the other immediate health problems that have come with the job throughout this pandemic.

According to an article published in July 2020 in the American Journal for Infectious Control, the primary ways that healthcare professionals managed best to cope with the stresses of their jobs included:

limiting their own exposure to media coverage and social media; limiting sharing their COVID-19 duty details with loved ones and community members; coping through religious practices and spiritual communities; and building capacity for altruism and empathy. Based on studies like these, the Centers for Disease Control and Prevention also recommends and provides some tips for adapting healthy coping strategies to manage stress, avoid physical or mental fatigue, and build resilience.

It is important to validate your feelings and experiences first in order to be able to recognize the need for self-care, indicates The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) in an article they released in July 2020. In their article, SAMHSA points out the signs of disaster-related distress and compassion fatigue; and offers tips and resources for getting help. They offer a downloadable pdf on their website; and it is suggested to print out the last page regarding resources and post it somewhere in your facility.

Regardless of our job titles, we all have important contributions to make to the stream of life and the web of humanity. As medical laboratory professionals and healthcare professionals, dealing with the unsustainability of work conditions present challenges that no human should be asked to overcome, and yet you have. How have you and your team promoted a more sustainable workplace through adaptive strategies like resource-sharing, self-care, and storytelling? Please share with us by replying by email at ptservice@slh.wisc.edu.

This article is featured in our monthly newsletter, The MedLab Retriever. Sign up for 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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