Testing the Tester--Lab Inspections 101

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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.

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Tags: Lab Testing, Theranos

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