Category Archives: Lab Management

It doesn’t make any sense

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For a variety of reasons my wife recently had a full panel of PFTs (spiro+BD, lung volumes, DLCO) at a different hospital than the one I work at. I went with her and was pleased to see the technician perform the tests pleasantly, competently and thoroughly. I was able to glance at the results as the testing proceeded so I had a fairly good idea what the overall picture looked like by the time she was done.

The difficulty came later when my wife asked me to print out her results so we could go over them together. Many hospitals and medical centers have websites that let patients email their doctor, review their appointments and access their medical test results. They go by a variety of names such as MyChart, MyHealth, Patient Gateway, PatientSite, PatientConnect etc., etc. My hospital first implemented something like this over a dozen years ago so I had thought that by now they were fairly universal but conversations with a couple of friends from around the country have let me know that this isn’t really the case.

Regardless of this, the hospital where my wife had her PFTs does have a website for patients and her PFT results showed up about a week later. When I went to look at them however, I was completely taken aback. Not because the results were wrong but because they were presented in a way that made them incredibly difficult to read and understand.

Here’s the report (and yes, this is exactly what it looked like on the patient website):

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State Licensure requirements for PFT Testing

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There has been a fair amount of confusion about PFT lab staff licensure requirements. This information is not available on the AARC website, nor on any of the AARC state society websites. A month or so ago I reached out to all of the AARC state societies but received responses from only a handful of them. I was recently able to complete this research however, by visiting the websites of the remaining state licensing boards and state legislatures.

It turns out that the majority of states require licensure of PFT Lab staff, most often by requiring CRT or RRT credentials, occasionally by allowing CPFT and RPFT credentials and in a couple of cases, a state licensure exam. There were also a couple of cases where the regulations were so vaguely written that it wasn’t clear whether pulmonary function testing fell under the Respiratory Care practitioner scope of practice or not.

Anyway, based on state society feedback and my best interpretation of the relevant laws and regulations, the following list should be a reasonably accurate look at the licensure requirements for each state.

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What’s in a name?

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My lab is in the final stages of a software update that will allow for electronic signing of our reports. This has been a long and slow process partly because the release date of the software got pushed back several times but mostly because a wide variety of different hospital departments and sub-departments have had to be involved.

In all the years that I’ve had computers in the pulmonary function lab I’ve never gone through a software update that was either as easy as expected or occurred within the original schedule. This includes the time when all we had was a single IBM PC/AT with a 40 megabyte hard drive, no network and the only people that cared we were going through an update was ourselves. Since we now have a dozen networked PCs located in two different building on-campus as well as three off-site locations using an IS-managed SQL server and HL7 interface I didn’t have any expectations for a speedy update and so far I have not been disappointed.

This time because the update revolves around electronic signing the hospital’s Health Information Management (HIM, i.e. Medical Records) department has been significantly involved. Among other things this has led to HIM reviewing all of our reports and requiring changes to bring them up to hospital standards. To some extent this make sense since, for example, they require that patient identification be exactly the same on all reports from all departments (same fields, same locations).

However, they also questioned some of the terminology used on our test reports. We’ve used the default test names that were in our report format editor (yes, we’re that lazy) and until they were brought to our attention I never really thought how odd some of them were. In particular, some of the terms used for the diffusing capacity didn’t make a lot of sense. For example, DLCO corrected for hemoglobin was DsbHb and DLCO/VA was reported as D/Vasbhb. To some extent I understand where these names came from but the reality is that they are in part holdovers from the past, in part they come from a need to keep names short so they fit in what space is usually available on reports, and in some cases they were probably created by programmers who hadn’t the slightest idea what the correct nomenclature should have been.

Note: Dsb likely comes from a time when you needed to differentiate between the results of different types of DLCO tests (steady-state and single-breath). Since there hasn’t been a test system built for at least 40 years that could perform a steady-state DLCO, the need to make this distinction is long since past.

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Filter FUD

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A lab manager recently emailed me and asked my opinion about whether it was okay to use generic mouthpiece filters on their test systems. They had asked the same question of their equipment manufacturer and received the following statement (parts of which have been redacted by me):

“The [model number] PFT system was designed/tested/certified using the [manufacturer’s] filter. While other “off-label” filters may fit our devices, they have never been tested or approved for use by [the manufacturer]. The precision and accuracy of our devices could be compromised by using different type filters. It is our recommendation that you continue to use the [manufacturer’s] approved filters with your PFT equipment.”

Since I doubt the manufacturer has tested their equipment with any other mouthpiece filters than those they sell this is in some ways a true statement. Having said that, it is also a statement designed to sow fear, uncertainty and doubt (FUD) in the minds of their customers about a subject that is relatively straightforward.

The human respiratory tract is a potential source of particles in the 0.1 to 20 micron range, particularly when coughing but even to some extent during quiet breathing. Mouthpiece filters are barrier filters and intended to prevent these particles from getting into PFT equipment. Filter manufacturer’s claims are very similar and usually state a “Bacterial filtration efficiency: > 99.999% and Viral filtration efficiency: > 99.99%”. In one sense this statement is somewhat disingenuous because mouthpiece filters are not tested with bacteria or viruses (which have diameters as small as 0.03 microns) directly, but are instead tested with aerosols generated by a nebulizer.

A HEPA (High Efficiency Particle Absorption) filter is a true bacterial filter and to meet standards it must filter out 99.97% of all particles 0.3 microns or larger. Mouthpiece filters are not HEPA filters, partly because of cost but far more importantly because HEPA filters have a lot of resistance to air flow. A HEPA filter is a sieve mouthpiece with opening sizes that prevent particles above a specific size from passing through. Mouthpiece filters instead work by impaction and electrostatic attraction. Larger particles are captured by impacting or otherwise being intercepted by the filter fibers and the fibers usually also have an electrostatic charge that attracts smaller particles.

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Static reports, dynamic world

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Reports are how patient test results are distributed. Paper versions have become less common because reports are now stored electronically in hospital information systems. Even if the way in which a report’s image is now stored, retrieved and distributed has changed, reports are still generated by our lab’s software systems and the ways in which this is done have not changed in any significant way for quite a while.

Reports are the public face of any pulmonary function lab and they should be designed to be readable and pertinent. It is critically important for any lab to create and manage reports correctly. So why does our lab software make it so hard to do this?

Over the last several months I’ve had the opportunity to compare the reporting systems of the three largest manufacturers of pulmonary function equipment in the US. There are differences of course between each reporting system since each has its own approach towards formatting, editing and printing reports. What they all share however, is a similar underlying model for reports that I call static report pages.

What I mean by static is that the report elements and their position on a report page are determined and fixed in place when the report is formatted. When the report is printed, regardless of whether the results are present or not, the report page does not change. This means that if you format a report to contain spirometry, lung volumes and DLCO, and the only test you perform is spirometry, when you print the report the sections for lung volumes and DLCO will contain no results but they will still appear.

The number of tests that need to be placed on a report will vary from lab to lab depending on what equipment they are equipped with. For example, these tests are available on one manufacturer or another’s test systems:

Spirometry

Lung Volumes – Plethysmography

Lung Volumes – N2 Washout

Lung Volumes – Helium Dilution

Diffusing Capacity

RAW/SGaw

MIP/MEP

MVV

SBN2

6MWT

FOT/IOS

There are probably other tests as well but even if there aren’t, there are other report elements such as demographics, text notes, flow-volume loops, trends etc. that also need to be managed.

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Where are your emergency plans?

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Around 20 years ago I had to write the emergency evacuation plan for the pulmonary function lab. Like many other administrative duties I learned that I needed to do this when my new administrator asked where it was and whether I had documented that I had reviewed it with the lab staff. Since I didn’t even have a real procedure manual at the time (just reprints of pertinent articles and textbook chapters) I ended up getting a crash course in writing policies. Fortunately the manager of a nearby departments let me borrow their evacuation plan and I was able quickly to knock one out that met the requirements fairly quickly. Since then I’ve had to review it annually and update it every time the lab moved or when rooms were added or taken away.

Yesterday I was reading the recently published ERS/ATS technical standards for field walking tests (and if you perform 6-minute walk or incremental shuttle tests then you will probably need to read it and update your procedures). One important change has been that because a 6-minute walk test can evoke a VO2 and heart rate response similar to CPETs the same absolute and relative contraindications now apply. For the same reason in the table of equipment required for walking tests along with the stopwatch and pulse oximeter the ERS/ATS standard now includes “An emergency plan”.

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Looking for help with an orphaned system

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I was contacted recently by a reader who is trying to resurrect an older test system.  It is a Spirotech S600, manufactured by Graseby-Andersen and outfitted for spirometry, helium dilution lung volumes and single-breath DLCO.  It seems to be in reasonably good shape but he cannot test the components or use it in any way because he does not have the software for it.  He is working on a shoestring budget and does not have funds to purchase a newer system.

If you have version 4 of the Spirotech S600 software (most likely on 5-1/4″ floppy disks), or if you have a manual or schematic for this system please contact Gabriel at gabriel_mendiondo@hotmail.com.

I don’t know if Spirotech was absorbed by a larger company or went out of business but the last Spirotech spirometers that I know of were manufactured around 20 years ago. Many of us are fortunate enough to be able to occasionally replace older equipment (although this is usually only when the older equipment does not work and can’t be repaired, and even then you have to jump through hoops to justify a capital purchase).  I have been in the position of trying to keep an older system functioning numerous times. The problem has always been that once a given test system has been replaced by a manufacturer’s newer model finding parts for the older model becomes difficult at best. More often it becomes impossible.

I don’t blame our equipment manufacturers for this.  I’ve watched pulmonary function equipment evolve for over forty years and every model was built with the technology available at the time.  But time moves on and trying to keep an older technology alive is always a lot more expensive than adapting to newer technology (and that’s even presuming that it was worthwhile to keep the older technology alive in the first place).  Still, there is a fair amount of older equipment out there that is at least potentially capable of functioning.  3D printing may be a partial solution to missing parts but I think the bigger problem is not so much physical parts but computer software.  Computers and computer software have been evolving incredibly rapidly and even if the software for an older test system was located more than likely the computer hardware the software was written for may no longer exist.  But there’s always Ebay so even this problem can potentially be overcome.

So, hold onto the disks and manuals that came with your test systems.  Even if you no longer have the test systems they were intended for they may still be able to help somebody else who is trying to make the best they can of a nonexistent budget.

Seeing shouldn’t always be believing

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Although the numerical results are of course important, visual inspection of the volume-time and flow-volume loop graphs from a spirometry test are a critical part of interpretation. Spirometry quality and performance issues that don’t show up in the numbers are often highly evident in the graphs. Choices we make in creating and configuring reports however, can hide important visual details and have the potential to decrease interpretation quality.

Recently I was inspecting the results for a spirometry test. There wasn’t anything particularly unusual about the numbers or the graphics on the report, I just like to make spot-checks on spirometry quality and wanted to make sure the best results had been selected. When I pulled up the raw test date on my computer screen I noticed an unusual wavering pattern in the volume-time curve. I don’t remember seeing a volume-time curve like this before and when I checked all of the patient’s efforts were similar and all showed similar oscillations.

VT_Curve_waver_redacted

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Assessing change over a long period of time

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Because our lab database goes back 24 years, we’ve started to see a certain number of patients who had last been seen ten or even twenty years ago fairly often. For this reason I’ve been thinking about what is a clinically significant change over that long a time period. The guidelines my lab uses for interpreting change in test results came about from a consensus among the department’s pulmonary physicians close to twenty years ago. As usual there are some discrepancies between our guidelines and those the ATS-ERS have published.

Test: %Change Minimum Change:
FVC >=10% >= 200 ml
FEV1 >=10% >= 200 ml
TLC >=10% ?
DLCO >=10% >= 2 ml/min/mmHg

Our criteria came primarily from the standards for repeatability in test results. The ATS-ERS guidelines for interpretation takes repeatability into consideration but also what appears to the minimum statistically significant clinical change. For year to year changes these are:

Test: %Change
FVC >=15%
FEV1 >=15%
DLCO >=10%

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How long should patient test data be retained?

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 In a recent post on the AARC Diagnostics forum a PFT Lab manager asked how long they need to keep database records. The ostensible reason for this was that they had too many years of records and had been having database problems.

The poster wasn’t specific about what kinds of problems they were having. Database problems can be hard to diagnose particularly when a database is networked but with a modern SQL database the number of records shouldn’t be an issue. SQL databases containing millions of records are routinely used in demanding multi-user applications. If this was thirty years ago when computers first started to be commonplace in the PFT Lab I could understand since PC-based databases were still in their infancy then. It was at least partly for this reason that a number of PFT equipment manufacturers developed their own proprietary databases. This is no longer the case and I have difficulty believing that there are any manufacturers at this time that don’t use a commercial SQL database of one kind or another.

I am not suggesting the poster wasn’t having problems. Even though SQL databases tend to be very robust that doesn’t mean that incorrect settings or bugs in the software accessing the database can’t cause problems. Equipment manufacturers and hospital IT departments may not have the expertise or the patience (or even the desire) to diagnose and fix these kinds of problems either. What I found curious however, was that almost everybody responding to the original post seemed to be eager to get rid of their “old” patient data as soon as they possibly could.

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