management/administration – Page 18

CLSI Publishes a New Document on Management of Critical- and Significant-Risk Results

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Management of Critical- and Significant-Risk Results (GP47-Ed1). This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results. Emphasis is placed on management responsibilities such as development of the policy, the process, procedures, job descriptions, and monitoring systems that ensure effective reporting and compliance with regulatory requirements.

This new document refers to results as critical risk and significant risk, depending on the degree of risk to the patient. The recommendations in the standard are intended to be consistent with best practices for patient safety, and compliant with current, pertinent regulatory and accreditation requirements. GP47 includes an executive summary and appendixes with sample policies, reporting methods, escalation procedures, and monitoring tools.

This document is intended for clinical and laboratory directors, managers, and personnel who develop and implement laboratory policies and processes. The standard is also intended for health care administrators who oversee compliance with regulatory requirements, accreditation, and clinical practice standards related to patient safety. The recommendations cover every laboratory discipline and pertain to clinical laboratories of every size, scope, and complexity.”

Lab Safety: A Deadly Ride?

Mumbai is one of the financial capitals in India, and millions of commuters ride its railway network to and from work every day. However, over the past several years, the available public transportation has not increased in proportion to the city’s rise in population. This has resulted in overcrowded trains and a staggering death toll from accidents and falls. In 2005, a total of 494 passengers lost their lives after falling from running trains. This figure went up subsequently in the coming years and climbed to 901 by 2013. In 2015 nine people a day, on average, lose their lives while on the move.

Knowing these facts, how inclined would you or your lab staff be to take a train ride in Mumbai? Not very. Yet, there are people in that city who willingly get on board every day. These conditions of danger are normal for them. This is their culture. They have become immersed in it, and it has become difficult for them to step back and look at the big picture–even for their own safety. They have to get to work.

In the past, laboratory professionals worked in departments where mouth-pipetting was normal, where eating, drinking and smoking was common, and where working without PPE was accepted. Today we look at old lab pictures of these behaviors and react (I hope) with surprise. But what applies to the commuters in Mumbai might also apply to labs of the past as well—those technologists were immersed in their culture.

Since those times, many lab safety regulations have been put in place, but that hasn’t fixed the safety culture everywhere. There may be, of course, other reasons for unsafe conduct in the laboratory. There may be behaviors that have been held onto after years of practice, there may be a lack of safety education, or safety may simply not be a priority for lab leadership. All of these factors are a part of the lab safety culture. Do you know the culture on your lab?

Assessing the culture in your laboratory is important. If you are in leadership, you should not assume that your singular view of the culture is accurate. There are several ways to evaluate the culture; make a visual assessment, review injury and exposure incidents, or have staff take a written culture assessment.

Provide adequate safety education for your staff. Are they aware that there might be a better, safer way? Do they know where the PPE and engineering controls are? Have they been trained in their use? Is there any safety leadership holding staff accountable so that there are not too many people on the train?

Laboratory professionals have to get to work, but unlike the workers of Mumbai, it’s not necessarily the trip to work that’s an issue; it’s the work places which are not inherently safe. It takes knowledge, education, training and focus to keep people safe in the laboratory. Put safety in its proper perspective: we are not dealing with falling from a train, but we do encounter injuries, exposures, and lab-acquired infections, some of which can be just as deadly as a fall. Know your safety culture, and learn what it will take to make the needed changes so that no one in your lab becomes a statistic.

-Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

One Part Interpreter

I’m thoroughly convinced that in order to change laboratory information systems (LIS) and get the new LIS to work correctly you need a mixture of one part laboratory professional, one part information technology (IT) specialist, and one part interpreter. Add together and then vortex vigorously.

The laboratory professional is a given. It is absolutely necessary to have a person or people who understand the lab tests inside and out, from linear range to reference intervals to instrument capabilities to antibiotic susceptibilities to type and cross-match. There must be people with an understanding of how the tests work and what type of information is needed in order to ensure that when a test result appears in the electronic medical record for the doctor to see, it is an accurate result that makes sense and is interpretable.

The IT specialist is also a given. This person or people must completely understand not only how to program the system, but what type of programming is possible – what the computer system is capable of doing – or not doing. Being currently immersed in changing LIS systems at my institution, I have come to appreciate more and more how these two individual types must be able to communicate with each other and work together to design and implement an LIS that is functional for everyone.

Which brings us to the “interpreter”. Sometimes IT and lab people simply don’t speak the same language. I know I sometimes feel as though the IT people have begun speaking in tongues. I’m occasionally amused by the totally blank looks on the faces around me, and no doubt on my own. Thus what a project like this requires is a facile communicator with enough knowledge of both the lab and the programming to successfully interpret between the experts. I’m calling this person an “interpreter”, but calling him/her a communicator would be just as accurate.

In my institution the interpreter role is most frequently filled by laboratory technologists who have gone over to the Dark Side, otherwise known as Information Technology. Much as I hate to lose them as medical laboratory scientists, they are pretty nearly worth their weight in gold as interpreters when changing LIS systems. To continue the analogy, without their input in the mix, the vigorous vortexing necessary often results in an emulsion, not a smooth mixture. The finished product may not function as desired simply because the programmer did not understand what was needed, or the laboratory professional did not understand the inherent capabilities of the LIS.

With any luck, we have enough interpreters in our mix to end up with a functional LIS we can all live with. I know the current meetings are going as smoothly as they are due to these people’s work.

-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

Are Feasibility Limits Feasible?

In the laboratory we’re constantly seeking ways to check that the test results that we put out are accurate. Our primary reason for doing this is that we want to make sure the patient is treated appropriately based on the results of the tests we run. Also, it’s nice not to release values that appear to be nonsense. A tool that is sometimes used to help us check results is something called feasibility limits.

Lab computer systems often allow you to enter feasibility limits for your test results or for your test parameters. These are values outside of which you would not expect to find an analyte concentration in a living person. For example, you might expect a serum creatinine of 200 mg/dL (17,680 µmol/L) in a zombie, but you wouldn’t expect to find one in a living human being. Setting feasibility limits helps you catch things that make no sense before the physician calls you on them, for instance if you have a decimal malfunction and mistakenly try to report a plasma calcium value of 90 mg/dL (22.5 mmol/L) instead of 9 mg/dL (2.25 mmol/L). The trick to feasibility limits is deciding on the highest or lowest value you might expect to see in a living human being. In the case of calcium, upper feasibility limits of 20 mg/dL (5 mmol/L) may give you wiggle room without letting you report nonsense. However, feasibility limits have their drawbacks also. One of those drawbacks is that I’ve found that with human beings, nearly anything is feasible, especially in the pediatric realm. I finally removed the feasibility limits from the LIS in my institution, after a couple of different episodes led me to that conclusion.

One was a body temperature on a blood gas analysis. Under normal circumstances one would not expect to encounter a body temperature much below 90° F (32.2 °C) ever. But of course hospitals are not known for their populations being “under normal circumstances”. The body temperature of the patient in question was 70° F (21°C) on a patient who had been cooled down for surgery. The blood gas instrument accepted the temperature, but the lab computer system would not because of the feasibility limits set in the computer. The patient’s blood gas results could not be released in the computer until we took the temperature feasibility limits out.

Another example was with sodium. It would seem reasonable to have an upper feasibility limit of 180 mmol/L for sodium. Yet we had a patient whose sodium was 199 mmol/L when he arrived in the ED. Reasonably expecting some sort of contamination issue, we requested another sample, which had a sodium of 204 mmol/L, followed by 200 mmol/L in the next sample. These were real sodium results and over the course of several days’ time the physicians managed to get the patient’s electrolytes normalized. Again, feasibility limits interfered with result reporting and had to be removed from the computer.

These episodes caused us to remove most of our feasibility limits from the computer. They also helped me to remember and important point: Tools are fine, but you must understand their uses and their limitations in order to use them appropriately. Feasibility limits can be useful as long as you keep in mind that with humans, you often see the unfeasible.

AMP Submitts Written Testimony about LDTs

From the press release:

“The Association for Molecular Pathology (AMP), the premier global, professional society serving molecular diagnostics professionals, yesterday submitted written testimony to the House Energy and Commerce Subcommittee on Health for their hearing on “Examining the Regulation of Diagnostic Tests and Laboratory Operations.” AMP urged the Committee to use AMP’s proposal to modernize the Clinical Laboratory Improvement Amendments (CLIA) at the Centers for Medicare & Medicaid Services (CMS) as the basis for legislation that would preserve innovative patient care by building upon the current CMS-based system for oversight of laboratory developed procedures (LDPs).

‘Molecular pathologists are highly trained professionals and our professional judgment is used throughout the design, validation, performance, ongoing monitoring, and interpretation of test results. It is our mission to ensure that patients have access to innovative, accurate, reliable, and medically useful laboratory testing procedures,’ said Roger D. Klein, MD, JD, AMP Professional Relations Chair. ‘The AMP CLIA Modernization proposal preserves patient access to essential laboratory services that would no longer be offered if a costly FDA-based regulatory system were imposed upon academic medical centers, cancer centers, hospitals and small independent laboratories,’ he added.”

To read the press release in full, visit www.amp.org.

CLSI Publishes a Revised Microbiology Document

From the press release:

“The Clinical and Laboratory Standards Institute (CLSI) has published a revised document titled Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria (M45-Ed3).This guideline informs clinical, public health, and research laboratories on susceptibility testing of infrequently isolated or fastidious bacteria that are not included in CLSI documents M02, M07, or M100. Antimicrobial agent selection, test interpretation, and quality control are discussed.
“Susceptibility testing is particularly necessary in situations in which the etiological agent belongs to a bacterial species for which resistance to commonly used antimicrobial agents has been documented, or could arise. The intent of this document revision is to assist labs in determining an approach for testing that is relevant to their individual practice settings.”

To order the document go to shop.clsi.org/m45.

Radiation in the Lab

Radioactivity is no longer common in most clinical laboratories. At one point in my career, radioimmunoassays were commonly found in laboratories, and most labs had institutional radiation safety plans and carefully followed the CAP checklist for handling and dealing with radioactivity. With the advent of enzyme-linked immunoassays, sensitive nephelometers, various fluorescent and chemiluminescent technologies, and then mass spectrometry, radiation was quickly replaced in most clinical labs. The general prevailing thought was: Why deal with radiation if you don’t have to? Now days, radioimmunoassays are essentially only found in reference labs and utilized for esoteric analytes or those which cannot be measured any other way.

Despite that being true, it’s important for a lab to know what to do if radioactive materials should appear in the lab. How likely is that to happen? Perhaps more likely than you may think. Last week a sample shipped to us from an outside institution set off the radioactivity monitor on our hospital loading dock. The package was on a delivery cart with other packages so per protocol, the whole cart went to nuclear medicine where it was determined that the radioactive package was for the lab and it was brought to us. The radioactive sample turned out to be a urine sample for VMA/HVA analysis from a patient on a new cancer treatment protocol. The urine was indeed radioactive.

The shipping institution was contacted and the packaging personnel had no idea either that the sample was radioactive, although they were aware a new protocol was going into place. Working with our nuclear medicine department and the institutional radiation safety group, we have now once again put appropriate processes in place to handle and deal with radioactivity. And we’ve dusted off our old CAP checklist regulations as well.

This episode actually turned out to be a benefit to us, as we discovered that our own nuclear medicine department will be starting this new protocol soon, and had not thought ahead to possible radioactive samples sent to the lab. We are now working closely with them to ensure proper procedures and safeguards, and have a plan of action clearly in place. We also continue to work with the institution that sends us samples. The very next sample from them was properly labeled as potentially radioactive.

Sample Stability and PO2–A Learning Opportunity

One of the interesting things about working in the field of laboratory medicine is that there are always opportunities for learning new things. Almost every call I get from my colleagues outside the lab allows me and the lab team these opportunities. And sometimes we are reminded of the reason we do the things we do, basically re-learning them.

Case in point: An ICU physician contacted the lab, understandably concerned. He had been monitoring the pO2 in a patient using an I-Stat point of care analyzer. Values had been in the range of 50-70 mmHg, and he had been adjusting ventilation on the basis of those results. A blood gas sample was sent to the main lab, analyzed on an ABL analyzer and gave a result of 165 mmHg, repeated shortly thereafter on a new sample with a 169 mmHg. Understandably, the physician wanted to know which analyzer was wrong and how he should be adjusting his patient’s ventilation.

We quickly did an investigation and determined an interesting fact that we hadn’t paid much attention to previously. A blood gas sample that is sent through the tube system that has any amount of air in the sample, will give falsely elevated pO2 result. We investigated this by collecting blood gas samples, running them on both the I-Stat and the ABL, and then sending them through the tube system and rerunning them on both instruments after tubing. The pO2 values matched on both instruments, both before and after tubing. But interestingly, if there was any air in the collection device when the device was sent through the tube system, the pO2 after tubing still matched on the two instruments, but the values were more than double the original values. If no air was present, there was very little change before and after tubing. We tested this by expressing all air from one set of samples before tubing and leaving air in the syringe on the other set.

The collection process for blood gas samples in our institution has always specified that the collector should express any air in the sample before sending the sample to the lab through the tube system, and after this incident the reason for that step became clear. However, the staff collecting blood gases on the floors needs to be periodically retrained in the collection, and the lab staff needs to be reminded that air in a blood gas syringe arriving through the tube station is a reason to reject the sample. We were reminded that education needs to be a continuous process. We also learned that when we discover the reason for a process, it’s a good idea to document that reason in order to both understand the need and to help motivate people to follow it.

Calling New Laboratory Directors and Managers

If you’re a laboratory director or manager who’s recently stepped into that role, the editors of Lab Medicine want to hear from you. As a new leader, you’re sure to have questions, challenges, and insecurities. Leave your questions in the comments, and it could be discussed in a future podcast.

Regulation of Laboratory Developed Tests (LDTs) – Revisited

Two years ago this coming September I posted a blog about the FDA’s intent to regulate LDTs and the need for laboratory professionals to both keep an eye on what happens and to be a part of it. I believe it’s time for an update on what has been happening and a further exhortation to stay involved.

The FDA is definitely going to regulate all LDTs. This is no longer a future possibility, but is now an approaching reality. In October of 2014, the FDA put out two new draft guidance documents for 120-day comment periods. One document, “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” lays out the FDA’s various risk categories and classifications for different LDTs and also lays out the FDA’s timeline for enforcing regulation of them. The second document, “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” delineates how labs will report their LDT testing to the FDA and the protocol for adverse event reporting to the FDA, which all labs performing LDTs will be required to do.

During the 120-day comment period, many groups commented, weighing in on their perspective about the FDA regulation of LDTs. AACC and the Association for Molecular Pathology (AMP) published position statements. CAP Today did a comprehensive article. Although nearly everyone agrees that some form of LDT regulation is necessary, there is a wide range of opinions on what that regulation should entail, and even who should ultimately be responsible for it.

Despite many suggestions that perhaps the FDA should approach this regulation differently, they plan to move forward. Their “Framework . . .” document lays out about a nine-year timeline for regulating all LDTs, starting first with the highest-risk group. LDTs will broadly be classified into three groups: low-risk, which are also known as “traditional” LDTS, moderate-risk and high-risk. Traditional LDTs are those developed by a single lab for use on a single patient population. This classification will cover many hospital-based LDTs and it will have the least rigorous regulation by the proposed guidance documents. Moderate and high-risk LDTs will be tackled first by the FDA and will require pre-market review and approval as part of the regulatory requirements.

The FDA is perhaps listening to some of the comments being generated however. Most recently the FDA has announced that an interagency taskforce will be formed to deal with LDT regulation. Currently that task force includes the FDA and CMS, although many laboratory associations are hoping it will be expanded to include more groups. As laboratory professionals, it’s up to us to stay informed of this new regulation headed our way, and to do our best to be involved in the process.