Ask the Expert

INTRODUCTION OF OUR NEW EXPERT (Barry Craig)

Laboratory Consulting, LLC was founded in 2000 with the goal of helping physician office laboratories provide quality, cost-effective services to their patients. Laboratory Consulting, LLC has a great reputation with regulatory and accrediting agencies, especially with CLIA and COLA. CLIA inspectors routinely recommend our services to POL’s (physician office laboratories) that are struggling with compliance problems. If you are just starting up, the CLIA application and accreditation process can be tricky, but Laboratory Consulting, LLC can streamline the process. The bottom-line: From starting your own in-house lab, post-inspection follow-up, to advice on tests and product selection, Laboratory Consulting, LLC can help!

Barry Craig has over 18 years experience in small laboratory management. He is currently the Laboratory Coordinator for 22 physician office laboratories for a large Birmingham health system. Barry has spent his entire career in laboratory medicine, working in all types of laboratories, both large and small. Over time, he found that his true interest was in helping POLs establish and maintain a great in-house laboratory. His focus has been on the small practice for years. He has developed a copyrighted system that is designed specifically for POLs and both technical and nontechnical users.

Hi everyone!

I am honored to take over this advice column from Dr. Sheila Dunn. Dr. Dunn is one of the greats in the field of Laboratory Medicine and is a personal hero of mine. She probably isn’t even aware she has groupies!

Needless to say, I will do my absolute best to answer your lab related questions with a large helping of humor and a small dash of wisdom. A small dash may be overstating. I look forward to the challenge, so bring on the questions!

July, 2008

Help! I have an inspection in three days and I feel so unprepared. What can I do to make it go smoothly?

Well, with only three days before inspection, I would take an extended vacation to a South American country with a “no extradition” treaty with the USA. That way your Medical Director can’t get her hands on you should things not go well.

Seriously, there are some basic guidelines you can follow to make any lab inspection better.

1. The devil is in the details

Look for gaps in all your record keeping. Initials or signatures that have been omitted or overlooked or QA reviews that were not completed. Any missing QC must be documented as to the reason. Reviews of PT must be signed. Any missing personnel documentation of training or annual competency testing and review must be resolved.

Organize your documentation in a logical, easy to follow order that will give your inspector an easier review. Group items by month or by week.

Try to have all documentation in one spot so that the inspector does not have to constantly ask you to go and find something. Remember, the less time the inspector has to wait, the sooner they get finished.

2. Attitude determines altitude

The inspector keys on how you present yourself. If you are nervous, short-tempered or hostile, the inspector will usually return the favor. Try to put yourself in their shoes. They visit hundreds of labs per year, and see the same violations repeatedly. They understand they are not going to win any awards for “Most Loved Profession”. They probably attend low self esteem meetings with IRS agents.

Treat them with respect by having the Lab Director at least greet them and shake their hand. A simple statement from the Lab Director of “ I am seeing patients today, but if I can be of any help, please let me know” usually is all that is necessary. The inspector understands that the physician’s first priority is to the patients and will usually not need the Lab Director any further.

Answer questions honestly. Any deception on your part will only cause them to dig deeper.  “I don’t know, but I will find out.” is a perfectly legitimate answer. Sometimes inspectors will ask a loaded question just to see if you will answer truthfully.

3. You say it best, when you say nothing at all

      Do not volunteer information that you are not ask for.

Example: If you are ask “Do you measure temperature and humidity?”, your answer should be “Yes, here are the logs for that.” Your answer should not be “Yes, but we have only kept records for that for the last four months”.

The inspector has a job to do, please do not do it for them! Make your answers YES and NO.

I drove this point home a little too well for a client one day before an inspection. I attended the inspection and the conversation went something like this. The inspector had been poring over records for several hours and turned to the Lab Tech and asked “Do you know what time it is?” The Lab Tech replied “Yes”. That was all she said. Looking puzzled, the inspector then said, “Would you mind telling me?” The Tech replied “No, I wouldn’t.” That was all she said. Finally, with a large grin, the inspector said, “WHAT TIME IS IT?” The Tech replied “12:15PM”

He grinned again and said, “I am sure glad I wasn’t on fire, I would have burned up before you could direct me to an extinguisher!”

Remember, inspections are only a few hours out of one day every two years. But how you organize, prepare, and conduct you lab day to day can make all the difference in the outcome.

I have trouble with my Hematology controls from time to time. Is there a way figure out whether the problem is the machine or the controls?

I wish we all had a Laboratory Crystal Ball upon which to gaze and determine what our lab problems are. Unfortunately, if we did have a magic orb in the laboratory, CLIA would make us calibrate it.

Here are some simple guidelines for Control Troubleshooting.

If your controls are not working, you have three possible problems:

1. An instrument problem.
2. A control problem
3. A human problem

An instrument problem

It is easy to determine if the instrument is the culprit.

For instance, if your platelet value on one of the controls is reading to high, change to another or new set of controls. If the platelet value for the same control continues to be out of range, you probably have an instrument problem. (see example below)

Old Control (Level Low)            New Control (Level Low)

89    Range  56 - 76                   86    Range  56 - 76

Check your calibration date, routine maintenance records, and previous quality control results.

A control problem

Control problems are a little trickier.

If a control has values that are out of range, open a new set of controls. If the new set performs within the expected ranges, the controls are usually the problem. But why do controls go bad before their expected lifespan? Ahhh, we now get to the major cause of most problems, the human. Pesky humans! As my granddad always said “People mess up everything! Left alone they could tear up a steel ball bearing!”

A human problem

If your control problems do not follow a set pattern or are sporadically out of range, you probably have a human related problem.

Observe your control errors: 

Do they occur only when certain employees run the controls? 

Are they being handled and mixed properly? 

Are they only out of refrigeration as long as the manufacturer states?

If only one control is bad, sometimes it is because the control has been dropped.

Excessive or rough handling of the controls can cause erroneous results.

Improper storage (temperature too high or too low) can cause erroneous results

If your problem can be traced to a particular employee, document reeducation and follow-up competency testing.

Also, your instrument manufacturer usually has a toll-free technical hotline. This is always a good choice if your troubleshooting skills do not reveal an answer to your problem.

My Medical Sales Rep says we can make XXX dollars if we add a certain test to our menu. How can I judge what the cost will be to run the test?

Sales Reps are notorious for quoting great profit numbers if you add a test to your menu, but they rarely include all the cost involved. Here is a list of the actual cost you may encounter when starting a new test.

1. Reagent cost – Any consumables used by the instrument or system.
2. Calibrator cost – This cost can vary depending on the test. Some tests only require twice yearly calibration while others may require calibration every two weeks.
3. Control cost – This can include the normal cost of controls but also figure in the cost for duplicate runs of your controls if they have to be repeated because of failure.
4. Instrument cost – Often the instrument can be obtained at a reduced cost or even free if the consumables are purchased on a “reagent rental” program.
5. Ancillary supplies – If you are performing a Hemoglobin level, your cost would also include one alcohol wipe, one lancet, one piece of gauze or tissue and one bandage per patient test.
6. Tech time – Remember you pay the person running the test for their time, usually an hourly rate. Divide the time it takes to collect, run, and report out the test by the lab person’s hourly rate. This give you an idea of how much their time cost per test.
7. Proficiency Testing – PT (Proficiency Testing) is required on all non-waived testing and is recommended for waived testing as well. Remember to add this annual cost into your calculations of the total testing cost.

What considerations do I have besides cost when selecting new “kit” type tests such as Mono or Rapid Flu?

In general, there are several considerations to look at.

Get samples of the tests you wish to add from your Medical Supply Rep. These should be available at no charge. Run several tests using the controls and patient samples. DO NOT REPORT OUT ANY PATIENT RESULTS FROM THE TESTS KITS YOU ARE TRYING OUT.

Look for ease of use, length of time to results, storage requirements, etc.

How long are the expiration dates on the kit? Will you use enough of the tests before a kit would expire?

Can you get the same lot number if you buy multiple kits? This can save on QC cost as some test only are required to have external QC run once per lot number change.

Is there a discount if you buy a bulk number of kits?

How does the kit in question perform on Proficiency Testing? You can look at PT results for a particular kit to see how many incorrect results were reported.