Ask the Expert: The Halloween Edition: Scary Things That Affect Your Lab Inspections

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Halloween is here! In honor of the holiday, we are going to look at scary things that affect the lab and how they affect your laboratory inspections. SCARY: These are items that have little chance of affecting patient care, but are still red flags for an inspector. FRIGHTENING: These are items that have the potential to affect patient care, and are considered major citations. ERRIFYING: These are items that can result in the shutdown of the laboratory.

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Ask the Expert: Assessing Quality in Your Lab

This month I am forgoing questions and focusing on one issue. Quality Assessment. All laboratories, whether Waived or Non-Waived, need a solid QA plan in place. For Non-Waived labs it is required, for Waived labs it is a good idea. A good QA plan focuses on things that happen before testing takes place (pre-analytical), things that happen during the testing (analytical) and things that happen after testing (post-analytical). Should problems be identified or should opportunities for improvement present themselves, corrective action should be taken to insure and maintain a high level of patient care. Since the QA program is designed to improve patient care, it should continuously identify and monitor potential problems which may deter the delivery of optimal services. The program should objectively assess the scope of the problems and determine priorities for investigating and resolving problems. The laboratory staff is responsible for compiling data, investigating and documenting all quality assessment...

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Ask The Expert: Falling Lab Reimbursements

I am a primary care physician with a small in house lab. My reimbursements continue to fall and it is getting harder to perform testing and stay "in the black." Do you have any recommendations? I hear this lot. With the added burdens and decline in payments related to ObamaCare, the laboratory is suffering. One thing you can do is look at alternative testing. As an example, most offices check blood sugar levels on a Waived meter approved for home use. This type of glucose testing does not reimburse much at all. However, this is one meter out there that uses a different methodology and is more accurate so it is allotted a different billing code that reimburses much better. The same is true for occult blood testing. The standard guaiac fecal occult blood test pays a very minimal $3.50 to $4.50. However the iFOB occult blood test reimburses around $21.58. This higher specificity methodology is different from the old methods, and hence, it pays more. This technology is available from seve...

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Ask the Expert: Questions From Physician Office Laboratories

I am having trouble contacting the state CLIA office for where I live. Is there a list or something with this info? Yes there is. Here is the link to the CLIA contact database. It lists all the state agencies for CLIA and their contact info including addresses, phone numbers and emails. Regulations-and-Guidance Who is required to review and sign off on the controls, calibrations, etc. that are produced by the lab? If the tech that runs the instrument signs off, is that sufficient? For all non-waived labs, it is required to have someone listed as either technical consultant (moderate complexity) or technical supervisor and general supervisor (high complexity). These positions should review all documentation produced by the lab. If the Lab Director fills more than one role and also serves in one of these roles, then they must review and sign off on these records. The laboratory inspector cited us for not having a "traceable" thermometer for our refrigerator. What does this mean?...

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Ask The Expert With Barry Craig | October 2013

Q: What is best way to keep up with expiration dates for reagents, controls, and other materials? A: I suggest making an Excel database for all items you currently use. You can set it up to change colors when an item listed reaches its expiration date. Another method you can use is a shelf system. Put newly received items on a lower shelf and mark them with the received date. Put items in use on a higher shelf and date them with an opened date and open expiration date. What is an open expiration date, you ask? Glad you are so full of questions! The open expiration date is the date that a product expires once opened. Most reagents, controls, and calibrators are good until the date printed on the label as long they are not opened. Once opened, the expiration date is usually shortened to 30 or 60 days. Q: Who is responsible for performing the competency assessment? A: The Technical Consultant (TC) for moderate complexity testing is responsible for performing and documenting competency assessme...

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Ask the Expert with Barry Craig | September 2013

Before I respond to this month's questions, a suggestion. Now is the best time of the year to stock up on your seasonal flu kits. Manufacturers are making deals now that they will not make any other time. You can cut your cost sometimes by 30% by ordering in bulk before the season hits. So stock up, and swab away! (Kids love having a large Q-tip shoved up their nose). Q: Help! In my lab, I stand in the same spot for hours at a time and my feet are KILLING me at the end of the day. I know this is not really a lab question, but my feet hurt! Any suggestions besides the standard foam mat?A: I would talk your physicians into purchasing one of the gel kitchen mats. These are expensive, but it is heaven on your feet. Make sure the one you get is non-porous. You can find them online for about 100 dollars. Your feet and sanity are worth it. If they will not get you one, tell them your sore feet are walking out! Q: How do I look up a test to determine what CLIA classification it is?A: You can go...

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Ask the Expert with Barry Craig | August 2013

Each month, Barry Craig, POR's expert on Physician Office Labs, posts answers to some of the questions submitted by POR Magazine and blog readers during the past month. You can ask your question at the blog & experts portion of our website. We have two medical assistants that run our hematology machine. We would like to have a nurse practitioner learn to use the analyzer as well. What are the lab regulations regarding who can train someone in our office to do the lab testing? If the medical assistants have documented training for the analyzer and have had their competency evaluated, they can train the other employee to use the analyzer. They will need to document the training and assess their competency before allowing them to test patients. They also would need to add that person to the proficiency testing rotation. We have a practice with approximately 6000 active patients and are thinking of putting a POL. Is that a good idea at this time of significant change in the medical fie...

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Ask the Expert with Barry Craig | July 2013

Happy Summer! If you live in the deep South as I do, summer means HOT, sticky weather. But this year, no corner of our country has escaped the relentless heat. So with that in mind, I have one Southern joke about heat that can be adapted to where you live. It was so hot in (place town here), I saw a dog chasing a cat and they were both walking................. ot weather can put a strain on cooling systems, equipment, etc. Make sure that your lab environment is still meeting the temperature guidelines for your instruments. Close shades on windows and keep instruments, kits, etc. out of direct or indirect sunlight. Now to this month's questions. I had a glucose read HIGH on my meter in the pediatric office where I work. We sent the child on to the emergency room and their glucose reading was 812 mg/dl. Is there any way I could do a dilution and get a result myself if this happens again? First, you would have to know the linearity of your meter. When it reads high, at what number did the...

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Ask the Expert with Barry Craig | June 2013

Are Waived instrument tests as accurate as full size analyzers? My office is reluctant to get Waived instruments because our doctors are not sure how usable the results would be.  Waived instruments have gone through the FDA clearance process which includes method comparisons to other analyzers. These Waived instruments produce accurate results as long as two things happen. Proper training and competency of the user is established The manufacturer's guidelines for maintenance and quality control are followed. These instruments are only as good as the person running them. Without proper training, the results may not meet the intended outcome Our clinic found a cheaper urine dipstick to use on our analyzer. Is it OK to use a different brand? You really need to check with the manufacturer. If the manufacturer's guidelines prohibit use of other dipsticks, you cannot. Even if this is allowed, and even if the "B" brand manufacturer claims compatibility, it is the lab's job to establish tha...

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Ask the Expert with Barry Craig | May 2013

Each month, Barry Craig, POR's expert on Physician Office Labs, posts answers to some of the questions submitted by POR Magazine and blog readers during the past month.  You can ask your question here.  Summer is here!  The kids are out of school, vacations are around the corner, and the grass grows faster than you can cut it. Summer can present some challenges for lab people. If your lab is Moderate or High Complexity, you are faced with personnel challenges if you want to leave the office for a few days. If you are keen on seeing Mickey in Orlando, you are going to need someone to run the lab in your absence. CLIA regulations require that anyone who touches your instruments or equipment must meet three criteria: Educational Requirements – For Moderate Complexity, at least a high school diploma or GED. For High Complexity, at least a two year degree in Laboratory Science (MLT). Test Training – Your substitute must have documented train...

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Ask the Expert with Barry Craig

Each month, BarryCraig, POR's expert on Physician Office Labs, answers questions submitted by POR Magazine and blog readers.  You can ask Barry a question here. Where can I get references for chemistrytests I run in my lab? I would like to get a wall chart that explains each tests, drug interactions, etc.  I get questions all the time from patients about what certain tests results mean and I would like to be more knowledgeable. It is great that you want to be able to answer patient's questions, but it is better to let the physician explain any results or give any recommendations to the patients. However, most companies that sell instrumentation will provide you with a reference chart or booklet explaining the test menu and will give you information on each test. Contact your rep that sold the equipment to you and they should be able to get you something. You can also check with American Association for Clinical Chemistry (www.aacc.org) to see if they have any resources availa...

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Ask the Expert with Barry Craig

Each month, Barry Craig, POR's expert on Physician Office Labs, answers questions submitted by POR Magazine and blog readers. We already perform Moderate Complexity and Waived testing. How do we get a CLIAcertificate for High Complexity testing? If you already have a CLIA Certificate of Compliance or Certificate of Accreditation, then you have what you need. There is not a separate certificate for High Complexity testing. And now, the fine print. (You know, the teeny weeny print at the bottom of the contract that says you are getting shafted and you are required to like it.)  The personnel requirements are different for High Complexity testing than Moderate Complexity testing. For clarity, we are going to abbreviate Moderate Complexity as MC and High Complexity as HC (plus, I am a lazy typist). Lab Director Under MC testing, the lab director can be a physician that takes an online course to be lab director. Under HC testing, the lab director must be either a pathologist, board...

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Ask the Expert with Barry Craig | February 2013

Barry Craig is a physician office laboratory (POL) and diagnostics expert. With over 20 years of lab consulting experience, Barry helps practices develop in-house labs as a place to obtain fast, accurate lab results and maintain a healthy profit.  Each month, Barry answers questions from POR Magazine and Blog readers.  Here is a selection from this month's questions. My service contract expires next month on my analyzer. It was free for the first year of our five year lease. Do I have to renew the service contract? It cost a lot of money and the instrument is running great. “My instrument is running great” is probably the worst jinx you could possibly do to yourself. Take that line back while you still can! With that being said, renewing the service contract depends on a few things. Does the contract include required preventive maintenance? If it does, then you will have to renew the contract.CLIA regulations state that maintenance must be performed as often as...

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Ask the Expert with Barry Craig | January 2013

How about that? We beat the Mayan predictions and are still here! Welcome to 2013, the year of major political, economic, and healthcare changes. What can we do as the medical community to protect healthcare and the private practitioner setting? 1. Keep our cost low – Reduce expenditures as much as possible. Comparison shop for the items we consume in the medical field. 2. Use your voice – Write your congressmen, the president, local officials, etc. and let them know how you feel. Websites like www.popvox.com give you an avenue to let your voice be heard. 3. Stay informed – I know we are distracted with Snookie having a baby, reruns of Friends, etc., but let’s keep our ear to the ground to stay current on news related to healthcare. 4.”Bulletproof” your office – Perform internal audits on your charges, billing tickets, CPT coding, etc. Find the problems and fix them before an outside audit does. Insurance companies have stepped up t...

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Ask The Expert with Barry Craig | November 2012

We are not happy with our reference lab. Is there a good way to pick another one or are they pretty much all the same?   There are several good criteria for choosing a reference lab for send-out testing.  Location: This will determine how far your specimen has to travel to be tested. Your turn around time for receiving results is tied to how far the specimen has to travel. Also, the integrity of the specimen loses ground the longer it bounces around on a delivery truck. Customer Service: How does the lab respond to problems? Do they have dedicated representative to work with your office? If they fix a problem does it stay fixed or just crop up again a few months later? Testing: How much of what you send them is actually performed by them at their site? How much of what you send to them do they have to turn around and send out themselves to get results? Supplies: Are they willing to provide you with all the supplies and materials necessary to collect, transport and prepare the specim...

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Ask The Expert With Barry Craig | September 2012

  Q: The chemistry instrument we have uses DI water. We have a unit that creates it and filters it. The doctor wants to stop using this device and get water in gallon jugs from the supermarket. He says it is the same thing. Does this really matter for the instrument?     A: Yes, it actually matters a lot. Deionized Water or "DI water"  is just what it sounds like: Water that has the ions removed. Tap water is usually full of ions from the soil (Na+, Ca2+), from the pipes (Fe2+, Cu2+), and other sources. Even water by the gallon, unless it is specifically deionized water, can have impurities in it.   When you are using a chemistry analyzer, the ions in water can cause interference. They can switch places with other ions you may be interested in finding. An example is calcium. If the water you are using has a lot of calcium ions in it, it could give you false results for calcium on your instrument. Also water with ions in it is also quite a lot more electrically con...

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Ask The Expert With Barry Craig | June 2012

We are thinking of doing lead testing in office in order to increase compliance with routine screening lead testing. I was advised that this will commit our practice to some regulatory result submissions. Is this just for abnormals? Can you advise me where I can investigate the requirements so that I may stay compliant with any medio-legal rules or regulations? A: The Lead Care 2 is the only device I am aware of that can be used in the physician office for lead testing that is in the Waived category. You would have to have a Certificate of Waiver to use it, but Proficiency Testing would not be required. If your state has regulations requiring submission of your results, you would need to contact the Department of Public Health for your state to learn what is required to be submitted. Q: How does our highly complex lab become a Blue Plus lab? I was told that our lab could perform more lab testing if Blue Cross recognized us as a Blue Plus lab and not just a POL. A: You need to contact...

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