Medicare Gets This One Right–For Now!

If you change your mind…

…I’m the first in line.

ABBA-1978

A few months ago I wrote a blog post about a Medicare proposal that was absolutely blowing my mind. CMS, the agency that runs Medicare, had it in it’s collective head that the prostate specific antigen (PSA) blood test, the test that checks men for prostate cancer, should get the boot, giving men a literal kick in the ass. The proposal apparently would have penalized the quality score of physicians who ordered the test to screen men for the disease. This prohibition even extended to men of an appropriate age for testing and in a high risk group such as being African American or having a strong family history of prostate cancer. Now I know the test isn’t perfect, but as a pathologist who sees about 30 cases of prostate cancer a week, and have also had my father die of the disease, I can tell you that any steps that help identify prostate cancer can’t be all bad.

I was not alone in my belief. CMS received 358 public comments about the proposed new policy. One of them came from me, maybe a few came from readers of my earlier blog post. The American Medical Association, The American Urological Association and The Large Urology Group Practice Association all chimed in. And CMS listened! Medicare has announced it has “temporarily suspended development of the draft measure.” That’s not exactly a strong endorsement for having a PSA test, but at least physicians who order it on their patients won’t face any penalties or sanctions. Thanks for coming to your senses, CMS!

As we have discussed before, PSA has its drawbacks. Many men with an increased PSA do not have prostate cancer. Some men who will be biopsied will have a cancer that does not require treatment. But as part of an all around health plan for men, and when the pros and cons are explained by a primary physician or urologist, the PSA test, definitely has a role. Maybe in the future we will have another test that is more reliable, equally available, and equally inexpensive. But right now, we don’t.

My dentist has a placard in his exam room reading “You only need to floss … the teeth you want to keep.” That is how I feel about PSA testing. I think I’ll hang a sign in MY office “You only need a PSA … for the men you want to keep.” Pass it on.

——————————————————-
You never know what you will find here. To subscribe type your email address in the box and click the “create subscription” button. It is completely spam free, and you can opt out at any time.

Can Newman and Redford Paint Our Lab or Fund Our House?

Remember-one man’s ceiling…

…is another man’s floor.

Paul Simon–1973

How many of you remember the two great Paul Newman/Robert Redford buddy films from the late 60’s-early 70’s? Most people of our certain age can probably recall “Butch Cassidy and the Sundance Kid,” but my favorite was “The Sting.” The two played a pair of con men trying to work the ultimate grift on gangster Doyle Lonnegan, played by the appropriately fierce Robert Shaw. In one scene, the con men and their team, posing as house painters, fake a Western Union agent out of his office and paint a wall or two before vacating, leaving the unhappy agent to return to a half painted office and a big mess. And that’s what we have here at the lab. No con, just the big mess!

The lab has been operating for more than 10 years, and the walls, floors and ceilings are showing their age, not to mention wear and tear from exposure to formalin, paraffin, and other assorted chemicals and solvents. So working with building management, we agreed on new paint, carpeting and ceiling tiles, as well as refreshing our vinyl flooring which was deemed too difficult to replace. The problem was how to coordinate all that work with a lab that has some sections open seven days a week, and others that work on a pretty tight schedule to get our cases out on a daily basis. No way can we shut down for a week, or even a day or two. And oh yes, we have an unannounced accreditation inspection coming up. We have to look all in order for that, whatever day it may fall on.

After multiple walk-throughs with the building agent and several different contractors, we arrived at a work schedule. We were provided with a floor plan of the lab, highlighted with seven different colors, each representing a different work phase, each to be done on a different weekend. Doing our best to not interfere with the daily work flow except for those pesky Chemistry and Microbiology sections with their weekend hours. Now that was really tough to work around!

So the painters and ceiling guys are hitting those sections on the run, painting Chemistry on a quiet Monday, and Micro between plate reads from Friday night to Saturday morning. We have pleaded with the painting crew not to unplug any incubators, refrigerators, our temperamental tissue processors, and so far they have been gentle. On the downside, the non-toxic paint is giving everyone a headache and making us all cranky. Our Safety Officer is popping the respirator masks out. And the paint just keeps on rolling.

So with the ragtime theme music from “The Sting” (Marvin Hamlisch playing Scott Joplin’s “The Entertainer”) playing in the background, I ask how all of you have dealt with maintenance in the workplace. Any secrets to your success?

——————————–

On the home front, construction is moving along, though not as quickly as everyone had hoped. First floor walls are up, and with good weather we should make some progress this week. Barb and I (well, mostly Barb) are struggling through all the essential decorating decisions. So many choices. So many permutations and combinations. So much money! But I have the ultimate trust in Barb to get it right, and still leave a few dollars in the rainy day fund. And if we go broke, we can always try pulling a con. It worked for Newman and Redford!

You never know what you will find here. To subscribe type your email address in the box and click the “create subscription” button. It is completely spam free, and you can opt out at any time.

Never Let a Doctor Plan Your Lunch!

You can get anything you want…

…at Alice’s Restaurant

Arlo Guthrie-1967

It seemed like an easy enough chore, planning for a laboratory meeting next week. We have a few things to discuss, including an upcoming accreditation inspection. Lunch time meetings tend to be the most convenient and are the norm, with the company usually ordering in the lunch. But I didn’t want the lunch room table cluttered with the large pizza boxes or or worse yet chaffing dishes, that would get in the way of the materials I was planning to distribute. Pre-ordered individual sandwiches seemed to be a good alternative. Along with a bag of chips, the sandwiches would be easy to pass out to each lab employee and still leave the table fairly free of clutter.

I had been hearing a lot of Jimmy John’s radio commercials recently, and I figured that any place that advertised Freaky Fast sandwiches should be a snap to set up and order from. I Googled their website and flipped over to it. What I wanted was a fax order form, something I could print out, stick on the lunch room table a few days in advance, and collect everyone’s order. Easy squeezy. Until I explored the web site. Couldn’t find the fax form that I had in mind. But there was a tab for “group ordering.” That’s what we were, right? A big group of hungry laboratorians.

First step, choose pick up or delivery. Fast delivery is what these guys are supposed to be known for, and besides, no one here has time to run out and do a pick up, so that was an easy choice. Entering our lab address for the delivery was a bit more frustrating. Enter the address, click next. Oops, getting an error message saying the nearest store is closed. Well, of course it is closed, it is 8:00 a.m. I didn’t want to talk to the store, just set up an online order on the system.

Finally, after 20 minutes of link pushing, I was able to have the lab address accepted and find the online order form. Let’s see how this works. Enter the date and time we want the delivery. Enter all my lab people’s email addresses so the site can send them an email with a link to our group order. I can include a little explanatory message. The employees can then follow the link and place an order. I can even limit the amount they can spend–we have some big eaters. I laboriously enter all the email address (can’t use the “quick option” because not all the emails are going to the same domain) and press “Send”. Error message pops up “You Must Choose Your Recipients.” OK, I put check marks in the boxes in front of everyone’s name and press “Send” again. Same error pop-up. Reclick same boxes and press “Send” for the third time. Success! Jubilation! Until I get three beeps from my Inbox. I check and see I have now received not one, not two, but three emails from Jimmy John’s inviting me to place my order. And oh yeah, the emails give me a 15 minute deadline for placing the order. Nice! Just right for confusing and/or panicking the employees.

Called the local Jimmy John’s–by now enough time had passed that they were open. Explained the situation, and got the expected “We don’t have anything to do with the website and don’t have any way for you to contact them.” But they were informed enough to let me know that unless everyone who had gotten an email responded, the order wouldn’t get placed. Great! One non-compliant employee and everyone starves, or at least misses lunch.

At this point I did two things right. First, I found the “Cancel Order” tab. Fortunately, that one worked. Second, I asked our lab office manager for some advice. She suggested Chipotle. They have a nice, easy to use, fax order form. And besides, we have a bacteriology lab. Worry about Salmonella? Not in our house!

Want to keep following? Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

5 Things Your Pathologist Never Told You

Doctor, doctor…

…give me the news.

Robert Palmer-1979

We have been called “The Doctor’s Doctor.” Pathologists stood in the background for decades, running laboratories, interpreting biopsies, staging tumors and making diagnoses. We rarely exposed ourselves directly to patients. There is even a law in New York State that explicitly prevents such contact. But now we live in a much more connected world. At the dawn of the digital age I created Pathwise, a company that “translated” biopsy reports from medical jargon to easy to understand English for patients with a desire to know. Now pathologists communicate via the Web, via Facebook, via Twitter. But even with all this improved interaction, there are still things you may not know about what really happens to your blood or your kidney or breast once it exits your doctor’s office, your hospital bed, the O.R. And even less that you might know about the pathologist who coordinates all the activity.

Most likely, the laboratory that analyzes your specimens has a pathologist as a Medical Director. To have an accredited laboratory, there is a long list of obligations and requirements that the Medical Director must ensure are occurring. This does NOT include running every blood test or making every slide personally. It DOES include verifying that qualified, well trained personnel are on hand to perform those tasks. And the scrutiny we are under to guarantee that keeps on growing.
Pathologists deal with our own version of Moore’s Law. In computing, Moore’s Law predicts that over time, denser and more powerful integrated circuits will be developed. In pathology, we are faced with the proposition that tissue samples are getting smaller and smaller, but the amount of information we need to derive from them is getting greater and greater. In the last decade, tests looking at cancer cells for the various changes in their genes–how these cells differ from normal cells–are becoming essential in determining the precise type of tumor in a biopsy, as well as in deciding what chemo- or immunotherapy treatments will work best for a particular patient. And by the way, those tests are not cheap.
The concept that there is a sharp line that separates “benign” from “malignant” can be a false one. Yes, in the vast majority of cases I can unequivocally call a biopsy benign or malignant. But that border line can be fuzzy; there can be a gray zone. Sometimes we just cannot accurately predict how a tumor will behave. And it is not just us local diagnosticians who are in this quandry. National experts don’t always agree on the nature of what they see under their microscope. And it can be a moving target. As new techniques are developed, and as our knowledge of the molecular underpinnings of illness grow, our interpretations and naming of disease processes change as well.
You may be surprised to see a bill from a lab halfway across the country. Not all of your blood tests or tissue tests are performed locally. Some large national laboratories operate central hubs which may handle all specimens from a wide geographic area. Some more esoteric tests, particularly molecular and genetic studies on tumors, may only be performed at one laboratory in the country. Laws relating to patenting of genetic testing have changed, but laboratories can still create test combinations that are difficult to duplicate elsewhere.
Pathologists are frequently leaders in a Medical Center. With offices and laboratories in the hospital, the pathologist often spends more time in the building than their clinical colleagues. This, combined with a general sense of trustworthiness, lead to many roles both within the administration of the hospital and the concerns of the physicians that make up the medical staff.

One more thing. Most pathologists love their job!

Want to keep on top of things? Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

March Madness Bracketology-Presidential Style

I’m winning…

…and I don’t intend, on losing again.

Santana, 1981

March Madness! How have your brackets been doing? Michigan State? Kanas? Oh, no, I am not talking about THAT March Madness. I am talking about that other hardcourt, hardball challenge, the 2016 Presidential Campaign. Just as the the NCAA Men’s Basketball Season started long ago, so did the Campaign. Lets gaze into our backward crystal ball and take a look at how these brackets shaped up way back in the fall of 2015. Think it was tough then to pick the top college bball team? How about trying to seed the candidates?

Republican Region Tournament:

Last fall was a long time ago, but the rankings were something like this:

Governor Division-Because the State House can produce a Jimmy Carter, a Bill Clinton, or a George W. Bush.

Jeb Bush
Chris Christie
John Kasich
Mike Huckabee
George Pataki
Scott Walker
Rick Perry
Jim Gilmore

Congress Division-Because we all love how functional our US Congress has been.

Ted Cruz
Marco Rubio
Rand Paul
Lindsey Graham
Rick Santorum

Outsider Division-Because if you can bankrupt a company you can run a country!

Ben Carson
Donald Trump
Carly Fiorina

So who was your money on way back then? Back before the debates, the name calling, the protests and the unholy alliances. If I were a betting man, which I rarely am, I would have put the short odds in the Governors Division on Jeb. So did most of the big money. So did the pollsters. But he never made much of a move, did he? Quite an upset. I am sure his lackluster performance busted a lot of brackets. Hard to predict that it would be Kasich coming out of that Governors Division on top. Who thought that last fall? Who outside of Ohio had even heard of him last fall? Just like a number 12 seed, some how slipping past higher rated rivals.

Oy, the Congress Division. Was there anyone in there that emanated “President?” Mean Ted is the division survivor, but I don’t see him getting out of the Final Four.

On to our Outsiders. In the NCAA Tournament everyone loves the Cinderella team. Everyone cheered Wichita State in 2013 as the Shockers made a run to the Final Four. Everyone loves an underdog. But who could have predicted that the Republican Cinderella, the one who could blindside all the guys and gals going for the glass slipper would be Donald Trump? The dude can hit from anywhere on the court, just like Stephen Curry. He plays a tenacious defense that hasn’t been seen since Scottie Pippen. This is NBA talent playing against college level ballers. He has clinched the Outsiders Division. But do we really want to see him win the Republican Region and advance to the Finals in November? Maybe it is time to call a few technical fouls and get him tossed from the tournament.

Democratic Regional Tournament:

Hillary Clinton
Bernie Sanders
Martin O’Malley

Not much of a bracket, is it? More like a long drawn out best of seven series. The Damn Yankees vs the Washington Senators. And Bernie Sanders isn’t getting secret help from the Lola or the Devil. Some excitement in the first couple of rounds, but I think we all know how this one will end up. Just wake me up before the final buzzer.

It’s been a long slog, and it has a long way to go until November. Just remember that if your candidate loses, there’s always another season. There is always 2020!

Want to stick around? Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

FISH: A Little Known Lab Test for an Important Disease

And it’s one two three…

…what are we fighting for?

Country Joe McDonald and the Fish-1965

It is early morning, 6:30 a.m. I sit in a dark room, staticky music from WXRT playing on the beat up radio in the corner. The setting is ripe for meditating, but my meditation consists of peering through a large, clunky, microscope. I see glowing blobs of blue, shiny pairs of dots reds and yellows, greens and aquas. I make notes on a score sheet. I am without a rod and reel, there is no lake or river nearby, but I am on my morning FISHing trip.

I’ve talked about prostate cancer and looking at biopsies a few times here, but we actually process more specimens related to bladder cancer. Sometimes we get small biopsy samples, taken by the urologist during a cystoscopy procedure, but more often it’s the Yellow River that provides the material for us to analyze.

Most people don’t realize that urine contains a myriad of cells that drift off the inner lining of the bladder into your pee. Our job in the lab is to look at those cells and determine if any of them are suggestive of cancer in the bladder. How do we do it? We have a couple of different methods.

Our simplest test is called cytology. Our great lab team first centrifuges and then processes the urine specimen until a thin layer of cells covers a glass slide. Those cells are then stained with the Papanicolaou stain, and yes that is the same one used in a traditional Pap smear. Several pairs of eyes look at the stained cells, and any significantly abnormal ones are noted and reported. We do about 50 of those cases a day.

But my early mornings are spent in the dark room FISHing. FISH, which stands for Fluorescent In-Situ Hybridization, is a technique in which a glass slide covered with cells is stained with probes that mark specific chromosomes in each cell. Each probe is formulated to light up a different color when examined in the dark under ultraviolet light. Our special microscope is equipped with a UV light and four different wavelength filters. We examine each cell, and by switching filters are able to count four different chromosomes. Two of a kind is normal, when a cell has an increased number of chromosomes, we start to worry.

Our system is automated. It is linked to a computer that can do the initial screening of the cells and then take digital photographs for the pathologists to examine. But I like to get into the FISH room in the morning, turn off the lights, and look at those cells myself. Peacefully floating down the FISH river is a great way to start the day!

Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

Donald Trump Takes On Artificial Intelligence

Oh the games people play now…

…Every night and every day now.

Joe South–1968

A “Downsize, Maybe” interview with Mr. Donald Trump:

“So I have been hearing a lot about this artificial intelligence machine, Google’s AlphaGo. I hear Google didn’t actually develop this thing, they just bought the company. It was a British company. Now I think that Google is smart for buying something like that instead of wasting time thinking about it, but if you check you will see the company was created by people with foreign sounding names. Google has got to be careful about that. And AlphaGo got all this publicity by beating another foreigner in a game called Go. That game is Chinese or Korean or Latvian or something. We do not need to waste our resources playing games with those Japs or whatever. They are all short with small hands, and we all know what that means…and don’t worry about the size of MY hands.

And I saw that artificial intelligence movie last year, Ex Machina. I didn’t really understand it, but Ava, that roboty cyber chick was hot. I’d take her to bed any day, even if she was mostly plastic and not really a real woman. Sort of like Hillary. But since these AI things are supposed to be so good at games, I want to play that Ava broad in my favorite game, Monopoly. We can do it in a big auditorium and I will have millions of people cheering for me. Worldwide television. I would be the Top Hat because it shows how rich I am, even better than releasing my tax returns. Ava can be the dog token because, well, all women are. I want to be the banker, but since I am a gentleman, Ava-robot-dog can move first.

I don’t know what that braniac’s strategy will be, but I have mine all figured out. If she buys any of those low rent foreign sounding properties like Baltic, or oh my god Oriental Avenue, I will just build a wall around them. No way am I going to risk landing on those. And just watch, I will make her pay for those walls. And I am going to find a way to get rid of that Free Parking space too. No one gets anything for free, unless this country is dumb enough to somehow elect Bernie Sanders President. He’ll give you college for free, and then how would Trump University make money?

Anyway, my Top Hat is going to really speed around the board. And I don’t care if Cruz and Rubio and Kasich are in the crowd and cheer on the robot. My supporters can always beat ’em up. Especially that wimp Kasich. I’ll pay my fans’ legal fees, and not just with Monopoly money. Anyway, before you know it I’ll have Boardwalk and Park Place, with four houses, a hotel, a casino and a Trump Tower on each. After that brain freak lands on one of them she will be in the poorhouse. She’ll be singing the Trump Pledge in half an hour or less. Nobody beats the Trump in real estate. Nobody. Of course it helps when you start with a little of Daddy’s money.”

“Downsize, Maybe” fact checker: None of the above is true. But it could be!

Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

We Have Wood! Construction Progress

Isn’t it good…

…Norwegian wood.

The Beatles-1965

Spring is definitely in the air. Daylight Savings Time begins this weekend. And a peak over our construction fence lets us know that this is the season for building. In the last week, quite a bit has been accomplished. The concrete foundation has cured, and a layer of black goop applied to several of the concrete walls. The goop is optional water proofing, and it makes sense in view of our proximity to the retention pond. We are throwing in an extra sump pump as well. Now is the time to be in full protection mode. An ounce of prevention and all that…

Our steel beams have been set as well. I am not an architect or engineer, but I trust we have enough steel to shoulder the load. We plan to have lots of house parties, those steel beams better be tough! But even bigger news is that the wood and accompanying crew have arrived. We can hear their hammers ringing out. Its a sound we have been waiting a long long time to hear. It’s not all perfect–one of my four new tires picked up a nail somewhere and I can only assume it was from the construction site. Fortunately it only caused a slow leak and Laurel BMW was able to patch me up. I hope the patch lasts at least as long as it takes to complete the house. I want to park all four of those tires in the new garage!

Now we expect to see the framing move ahead rapidly. Then it will be time to install that peculiar green sheathing, the ZIP system. We still haven’t seen very many residential homes using it, we just hope it lives up to its billing as an energy saver. Anyone out there have any experience with it?

So now the pressure is on us. Make our decisions, get things ordered. Barb has most choices narrowed down. But there are an awful lot of moving pieces to make all the puzzle parts fit together in a timely fashion. No back orders for us…we hope!

That’s our current construction summary. But I feel like a little music trivia today as well. The word “Wood” made me think of double “o’s”. How many musical acts can you think of that have a double o in their name. Goo-Goo Dolls is an easy one. They are a double double. But there are lots more. List them here, or send them to me at lesraff@post.com

———————

Want to follow along with construction and anything else that pops into my mind? Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

No “Lovie” for Our Lab

We’re Loyal to You Illinois…

…We’re “Orange and Blue” Illinois

The University of Illinois have some big news. Former Chicago Bears Head Coach Lovie Smith is the new Head Coach of the Fighting Illini football team. This really draws statewide attention to the school. What a tremendous boost for the team’s biggest challenge, recruitment.

And recruitment is tough. Now, I’m not talking about going to a high school students homes and convincing the child and his parents that he wants to battle on the offensive line in Champaign for the next four years. I’m talking about the battle we face in the lab every time we look for a technician or technologist with the special training and certification we require. There are a lot of laboratories in the Chicago area, and we all look to the same pool of potential employees. It is not a big pool, and there aren’t that many new people flowing through the spigot into that pool.

What makes a good place to work? Of course salary is important. Beyond that, one of our supervisors did some research and identified perks such as in house yoga, professional on-site chefs and variable work schedules. Regular demonstrations of appreciation also help. We haven’t tried the yoga or gourmet chefs here, though there are frequent celebratory lunches and birthday breakfasts. And we do try to offer a competitive salary, show respect to all of the staff, and allow some creativity within the bounds of all those detailed SOPs. But perhaps we need to do a better job with the pats on the back. And it is also important, though in a much longer term, to make sure there are always new students entering the lab pool, to help keep the spigot on the full-on position. We appreciate the schools and training programs that provide the needed education. And I speak at local career days, but not as often as I should.

What makes you want to stay with a company, or look for a new one? Will the place with the biggest budget always win out? How do we succeed in a field with a limited pool of qualified applicants? The challenge is always there for us. Maybe we DO need Lovie Smith to go knocking on some doors for us. And if that doesn’t work, does anyone know where I can find Mike Ditka?

On another note, I have an additional album title for our previous music trivia question. “Stop Making Sense” is both a movie and a soundtrack album from David Byrne and the Talking Heads. The phrase is from the song “Girlfriend is Better” that was performed live on the album.

To follow our blogs type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.

Testing the Tester–Lab Inspections 101

Hey look me over…

…lend me an ear.

Wildcat-1960

A few months ago I wrote about some difficulties at Theranos, the laboratory testing company in California that was going to do more with less. Less blood that is. Since then, Theranos has had another lab inspection with less than stellar results, and major business partner Walgreens is reportedly looking for a way out of their relationship.

Those lab inspections can swing a lot of weight, so I thought I would give you all a peak into what a typical inspection looks like. After all, I have been through about 30 of them, and led more than a few inspections myself. These inspections may be required to maintain licensure or to maintain a relationship with Medicare. Some are from state agencies, some from other professional organizations. The inspection team may be peer “volunteers”, or a full time paid inspectors. Let’s imagine you are the lab director at a small private lab that is to be inspected by the (fictional) Cooperative Laboratory Accreditation Program, better know as CLAP. The scenario is something like this.

As the lab director, you will get a letter from CLAP, informing you that the anniversary of the lab is approaching and your will be undergoing an inspection. You aren’t told the exact date, just given a 3 month window during which the inspection will occur. You can pick ten “blackout” days during that period where you can be assured you will not be inspected, but other than those ten days, any weekday is a potential target. And if your window stretches over the entire summer, it puts a crimp on a lot of family vacations, especially for supervisors and managers.

How does your lab prepare for the upcoming inspection? In addition to that announcement letter, you are provided with a set of checklists with hundreds and hundreds of items. Most of these items stay the same from year to year, but there are always changes. Some years it is just a few, other years there are major checklist overhauls. It is on these checklist items that you are going to be evaluated. In this preparatory phase, you will review each item and ensure that there is a documented standard operating procedure that addresses the checklist requirement. The SOPs must be accompanied by evidence that they been reviewed and are current. My lab used to have about 15 large three ring binders filled with SOP documentation and signature sheets, now it is all digital and securely stored on someone’s cloud. That digital transition is something some inspectors still haven’t come to grips with.

What is the nature of the checklist items? They start by examining the three phases of laboratory testing: pre-analytical, analytical, and post-analytical. That is, how do you prepare specimens for testing, how do you test them, and how do you then report out your results? The checklist also investigate the qualifications of lab personnel, the physical condition of the lab, and compliance with various safety agency requirements. A key element is the evaluation of the programs that are in place to verify quality. In our lab, we have a bout two dozen ongoing “quality monitors,” measuring everything from the daily temperature–of the lab, not of the lab techs–to how long it takes to get a biopsy report completed.

Very early on some unknown day during your window, the lab will get a phone call saying “I am Dr. Testhappy from CLAP, and my team and I will be at your front door in one hour.” You spring into action, following a predetermined plan. A quick run to Panera Bread to pick up breakfast treats for all. An order placed to Real Urban Barbecue for the inspectors lunch. Any smudges wiped off lab coats and counter tops. And you remind all your staff to smile and relax.

Once the inspection team arrives, things move swiftly. Introductions, a lab tour, and then the checklists appear. The inspectors display various degrees of diligence. Some want to see every document and dig in for every signature. Some are mostly interested in doughnuts and schmoozing. The better ones actually go into the laboratory to see if what you do in real life matches what you say on paper — or in your digital files. They look at the glass slides the pathologists use to make diagnosis. They have an opportunity to meet with administrators, and with the doctors whose patient specimens are tested at the lab. In truth, these spokespeople are all carefully chosen well in advance. It is unlikely an inspector will hear “This lab does a terrible job, but I love ’em like brothers.”

Your lab is inspected in one day. By afternoon it is time for a Summation Conference. Inspectors and staff gather around the break room table, last traces of lunch brushed aside. As lab director you are given a list of “deficiencies” that must be corrected. Even in the best of labs, the inspectors find something to justify the hassle of the inspection. The inspectors take their leave, the lab makes a few changes to their SOPs and sends them to CLAP. Within a month or so, a letter arrives congratulating the lab on another two years of accreditation or licensing or Medicare participation.

And two more years of reliable, timely, lifesaving results for your patients.

Type your email address in the box and click the “create subscription” button. My list is completely spam free, and you can opt out at any time.