IN THE LAB - Cloudinary...Once again, Jen Gummer, MT (ASCP) CLS (NCA) of Boze-man Deaconess Laboratory Services has issued a challenge to fellow laboratorians and phlebotomy employees

In the last ten years, nucleic acid amplification testing (NAAT) has transitioned from being performed only in esoteric reference laboratories to being readily available in small community hospitals. This occurred due to the avail-ability of automated testing platforms, the abundance of FDA-cleared test kits now being marketed, and simplifica-tion of the testing protocols. The excellent specificity and robust sensitivity of NAAT have rendered many traditional test methodologies obsolete.

Microbial identification is an obvious area where NAAT could prove beneficial over tradition laboratory methods. Many pathogenic organisms can be identified in an hour or less, with high specificity and sensitivity. Even some resistance gene markers can be detected, such as the mecA gene responsible for methicilin resistance (MRSA) and vanA and vanB genes responsible for vancomycin resistance (VRE). This can decrease the time for the identification of a pathogenic organism from days to a few hours, allowing for faster, more specific antimicrobial therapy and more effective treatment. Many viral targets are also available for detection.

Genetic mutations have also been targets for NAAT testing. Common mutations in the coagulation cascade that can lead to increased risk of thrombosis can now be factored in when deciding on the correct therapy for an individual patient.

At Bozeman Deaconess Laboratory Services we are steadily increasing our use of molecular testing. Current platforms include:

• Hologic Panther (Chlamydia and Gonorrhea detection) Run once per day, Monday through Friday

• Cepheid GeneXpert ( MRSA, Enterovirus, Group B Strep, C. difficile, and Leiden V/Factor II mutation testing) 1-2 hrs — Testing 24/7

• BD Affirm (Bacterial vaginosis, Trichomonas, and Candida spp.) 30 min — Testing 24/7

• Nanosphere Verigene (Positive Blood culture ID system) 2 hrs— Testing 24/7

• BioFire Film Array (Respiratory panel for 20 common pathogens) 90 min — Testing 24/7

• Ilumigene (Bordetella pertussis) Done daily

• Hologic Cervista (High Risk HPV and genotype 16/18 testing) Done 2x weekly

• In the future, most departments in the clinical and

pathology departments will perform molecular testing. Blood banking, pathology, immunology and microbiology all have new molecular testing platforms available, with FDA approved protocols. As testing becomes available, each new NAAT will be evaluated to determine if it is ap-propriate for incorporation into our testing menu. As with all new technologies, there are growing pains, and due diligence will be exercised to bring in only quality, track-proven methodologies that provide a true improvement for our physicians and patients.

MOLECULAR TESTING IS READY FOR PRIME TIME

F o r m o r e i n f o r m a t i o n p l e a s e v i s i t u s a t w w w . b o z e m a n d e a c o n e s s . o r g / l a b o r a t o r y s e r v i c e s

IN THE LABIN THE LABA quarterly newsletter for healthcare providers from Bozeman Deaconess Laboratory Services

J U L Y I S S U E — 2 0 1 4

F o r m o r e i n f o r m a t i o n p l e a s e v i s i t u s a t w w w . b o z e m a n d e a c o n e s s . o r g / l a b o r a t o r y s e r v i c e s | 4 0 6 4 1 4 1 0 1 0

Once again, Jen Gummer, MT (ASCP) CLS (NCA) of Boze-man Deaconess Laboratory Services has issued a challenge to fellow laboratorians and phlebotomy employees to get up and get active. Gummer inaugurated the Summer Chal-lenge last year, after learning colleagues got bored in Boze-man despite all the great summer activities available, and to promote pursuing activities with coworkers so everyone can get to know each other better.

Participants earn points for completing as many activi-ties Gummer devised for the 2014 Challenge as possible. Points awarded are loosely based on difficulty, distance and possible expense. Options this year include:

• Go to a Farmer’s Market• Attend Music on Main• Float the Yellowstone• Golf • Visit a national park• Jump off a bridge, rope swing, or cliff

• Take your picture with Kevin Pitzer• Bike Hyalite Canyon from Moser Creek to

Sourdough Creek• Hike Triple Tree trail, South Cottonwood trail, or

to Cinnamon Mountain Lookout

Gummer intentionally picked activities that can be achieved by anyone, and she can provide directions or more information. The 2014 challenge runs from May to September 30th. Participants are asked to submit photos proving they have completed each activity.

Last year 20 people took up the gauntlet, and this year more participants are expected to compete. The grand prize is dinner for four at Gummer’s home. New this year is a prize for the “best/epic fail.” This would be a picture of when something just didn’t go well, Gummer said, such as a hailstorm during a float trip.

For more information, email Gummer at [email protected]

2014 SUMMER LAB CHALLENGE

Denise Pugh and Steve White at the 2014 Memorial Day Parade working on the 2014 Summer Lab Challenge

Jose McAdams in YNP at Slough Creek working on the 2014 Summer Lab Challenge

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CAP INSPECTIONSEach year, laboratorians at hospitals across the country have a CAP inspec-tion that requires everyone to get all procedures, Quality Control (QC) documentation, instrument validations, etc., in order.

One year is typically a self-inspection, where we inspect each lab department (such as urinalysis, chemistry, special chemistry, hematology, pathology, histology, microbiology) ourselves. In this case, one or two people inspect each area.

Every other year we are treated to a surprise inspection, usually in May. This inspection team can be another Montana hospital lab team or it can be a team from another hospital from across the country. These teams can go through all of our records, and using a CAP (College of American Pathologists) check-

list, they can ask questions and review everything we do. If they find us deficient in any area, we then have to correct the situation, and write an explanation to CAP.

We always feel more pressure when other lab people come to our lab for a “look see” at all of our records. We always strive for no deficiencies.

On May 15, 2014, we took our BDH lab team to Benifis Health Care in Great Falls, MT. Thirteen Bozeman Deaconess Labora-tory Services staff members were in Great Falls, pouring through procedure manu-als, checking out how testing is done and

how instruments are monitored while everyone at BDH was enjoying ice cream sundaes to celebrate National Hospital Week. We take our inspections seriously, so when the lab people are distracted in May, there is a very good reason.

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What does EDTA Platelet Clumper mean? The most common cause of platelet clumping in an EDTA speci-men is either improper mixing of the tube or improper collection of the sample from a difficult or traumatic venipuncture. If these were not the case, then an EDTA cause should be investigated.

EDTA is the anticoagulant used in tubes for the determination of com-plete blood counts. Associated with this anticoagulant is a phenomenon that is well known to cause erroneous low platelet counts. This phenome-non has been reported, rarely, in both normal individuals and in association with a variety of diseases, occurring in approximately 0.1% of the general population. Clumping occurs when a patient’s plasma contains an antibody capable of causing in vitro platelet agglutination. Most such patients have an autoantibody that is active only in the presence of EDTA.

The process of clumping is time-

dependent. Therefore a count drawn and run stat usually is correct, while a count drawn and run with the usual lapse of time associated with a routine or reference sample will have a spuri-ously low platelet count. In a minority of patients, clumping will occur in the presence of any chelating anticoagu-lant. In an even smaller minority, the clumping will occur almost instanta-neously.

When we see flagging on our instru-ment printouts of “platelet clumping,” we check the specimen for obvious clots and review the smear for clumps. In the case of obvious clots, the cause is improper collection, mixing or trau-

matic venipuncture. This is when the specimen is rejected and a redraw is requested. In the case of no clots, we review a slide and if there are obvi-ous clumps, we will report the counts with a comment stating that there was a flag and clumps present. The comment also says to eliminate an EDTA cause to redraw with a lavender (EDTA) and a blue (sodium citrate). The platelet count can be obtained only from the sodium citrate and, because of the anticoagulant dilution, we multiply by a factor.

Occasionally there are patients that clump in everything. A possible solution is to draw and run immediately, but as stated above that is not always a solution either. These patients should be informed of this phenomenon so that every time they are drawn, they can inform the phle-botomist and an extra blue tube can be drawn and labelled “for platelet clumper” so they don’t have to be repeatedly redrawn.Clumped platelets

EDTA PLATELET CLUMPER

Jen Gummer at the CAP inspection in Great Falls when she found out about the hospital ice cream social

Ice cream social at BDH


As summer nears and Montanans

begin to enjoy the

great outdoors,

Bozeman Deaconess

Laboratory Services is seeing more requests

for Lyme disease testing. Montana De-partment of Public Health and Human Services urges outdoors enthusiasts to use insect repellent, wear long light-colored pants and clothing, avoid potential tick habitats and check for ticks after outdoor activity in potential tick infested areas.

Laboratory testing can be an im-

portant aid in the diagnosis of Lyme disease. Proper use and interpretation of laboratory tests requires an under-standing of the type of test, the stage of illness, and the underlying likeli-hood that the patient has the disease.

Like blood tests for many other infectious diseases, the test for Lyme disease measures antibodies made by white blood cells in response to infection. It can take several weeks after infection for the body to produce sufficient antibodies to be detected. Patients tested during the first few weeks of illness often will test nega-tive and conversely, patients who have had Lyme disease for longer than 4-6 weeks will almost always test positive.

If a tick is found and is attached, fol-

low these steps to remove it safely:Use fine-tipped tweezers to grasp

the tick as close to the skin’s surface as possible.

Pull upward with steady, even pres-sure. Don’t twist or jerk the tick; this can cause the mouth-parts to break off and remain in the skin. If this hap-pens, remove the mouth-parts with tweezers. If you are unable to remove the mouth easily with clean tweezers, leave it alone and let the skin heal.

After removing the tick, thoroughly clean the bite area and your hands with rubbing alcohol, an iodine scrub, or soap and water.

Enjoy the great outdoors and see your care provider if you suspect or see evidence of a tick bite.

Tick-borne illnesses in Montana.

Disease/ causal organism

Incidence in Montana

Symptoms Tick vectors

Rocky Mountain spot-ted fever/rickettsiosis (a bacterium, Rickettsia rickettsii)

Rare, much more common in some ar-eas along the Atlantic coast. About 3 cases per year, on average, are reported in Mon-tana.

Initially, a general feeling of mal-aise and/or aches. A characteristic rash develops, starting on the wrists and ankles and spreading to the rest of the body, including the palms and soles of feet. High fever is associated with infections.

Rocky Mountain wood tick, American dog tick.

Tularemia (a bacterium, Francisella tularensis )

Rare, only 1-2 cases, on average, are reported in Montana each year. Can be widespread in wild animals, particularly rabbits.

Sudden high fever, general weak-ness and swelling/pain of the lymph nodes.

Rocky Mountain wood tick, American dog tick. Most human infections occur from contact with the blood of infected animals (e.g., while skinning rabbits).

Colorado tick fever/bi-phasic fever (a virus)

Rare, only 1-2 cases, on average, are reported in Montana annually.

Generally flu-like, including ach-ing, fever, chills and fatigue. This typically lasts for 1 to 3 days. More severe complications sometimes develop.

Rocky Mountain wood tick, American dog tick.

Tick-borne relapsing fever/borreliosis (a bacterium, Borrelia hermsii)

Very rare. Rapidly developing fever 3 to 10 days after initial infection. Fever declines after about 4 days but may recur in multiple cycles.

Soft ticks of the genus Orni-thodoros that are associated with rodents (e.g., chipmunks, pine squirrels). Human infec-tions typically occur when camping in rustic cabins inhab-ited by infected rodents.

TICK-BORNE ILLNESSES

Note: The deer tick that carries the causative agent of Lyme’s Disease is not found in Montana. However, travelers to areas where the disease is endemic are at rick.

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QUARTERLY NEWSLETTER FOR HEALTHCARE PROVIDERS

4TH GENERATION H.I.V. TESTINGIn May, BDH Laboratory Services started providing HIV screening using fourth generation technology. The procedure includes two distinctive tests: one for antibodies to HIV 1 and 2, and one for the detection of the p24 antigen.

The p24 antigen can appear within days after infection and several weeks

before the antibody test will be posi-tive. Detection earlier in the infectious process is important for both disease prevention purposes and to provide the patient with early treatment op-tions.

A positive HIV 1/2 antibody test will be reported as “preliminarily positive” and will automatically be forwarded to

Mayo Medical Laboratories for confir-mation and differentiation. A positive p24 antigen test will be reported as “preliminarily positive” and will in-clude a comment asking the provider to order HIV-1 RNA quantification and to ask the patient to return for this testing.

Mike Long, BS, (ASCP)Medical Technologist

The Dear Labby column is featured in each issue and is intended to answer lab questions that others may have wondered about but have never asked. Please submit any lab related questions to: [email protected].

Dear Doctor: Most molecular testing for infectious diseases aren’t rec-

ommended to be used as a “test of cure” because dead or nonviable organisms can still shed for some time. Speci-mens containing intact DNA can give a positive result even in the absence of viable organisms. DNA is relatively stable (as compared to RNA) and can be present for a long time, and even fragments of degraded DNA can cause a positive result if the target sequences are present.

Positive patients should not be retested at all if they don’t have diarrhea (3 stools/24 hours that take the shape of the container). If diarrhea does not clear, retesting won’t help and is likely to be positive again. If a new onset of diarrhea is noted later – > 1 week – a retest may be indicated.

On the same note: if a patient is negative the first time he is tested, he shouldn’t be tested again for 6 days. After 7 days, they can be tested again. If a provider insists on retesting a negative patient in less than 7 days, the lab will collect a new sample and note that a retest was requested. It is rarely going to be positive, but lab mix-ups, patient misidentifications and the like can occur.

Labby

Dear Labby:I have a patient who was symptomatic and tested positive for C. difficile.

Now I’ve followed up treatment with testing that shows the patient to still be positive. How long after treatment should I expect a positive result?

DEAR LABBY


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DEAR LABBY (CONTINUED)


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Dear ACDC:A thrombotic risk profile (thrombophilia profile) can be

useful for: • Evaluating patients with thrombosis or hyperco-

agulability states• Detecting a lupus-like anticoagulant; dysfibrino-

genemia; disseminated intravascular coagulation/intravascular coagulation and fibrinolysis

• Detecting a deficiency of antithrombin, protein C, or protein S

• Detecting the factor V R506Q [Leiden] mutation, if indicated

• Detecting the prothrombin G20210A mutation

It also certainly can be useful and necessary in deter-mining if your patient needs further attention to prevent future untoward coagulation events.

However, in the setting of acute thrombosis, the inves-tigation for underlying defects is often difficult. Clotting, inflammation and acute phase reactants alter coagulation regulatory proteins. The testing of individuals who are al-ready receiving anticoagulants should also be avoided be-cause anticoagulants as well as the acute event confound the measured laboratory values. Moreover, it is unlikely that the data achieved from an investigation during acute thrombosis will alter the patient’s treatment during the initial thrombotic event or for the subsequent few months.

When testing for thrombophilia, timing is critical.

“Quite a few patients are labeled as having thrombo-philia simply because their blood was tested at the wrong time,” says Dr. Dorothy Funk, MD, medical director of Esoterix Coagulation. “I think we may have many people in this country who have been incorrectly labeled with antithrombin, protein C or protein S deficiency.” Misdiag-nosis arises when a patient’s blood is tested in the hospital shortly after a thrombotic event or when the patient is on anticoagulant therapy.

“The best time for evaluation of thrombophilia,” Dr. Funk says, “occurs when there is no anticoagulant therapy and no acute thrombosis.”

To obtain the most useful information, this testing is best performed in medically-stable patients who are not receiving oral vitamin K inhibitor (e.g. warfarin, Cou-madin), heparin, low-molecular-weight heparin, hirudin (Refludian), argatroban, fibronlytic agents (eg streptoki-nase, tissue plasminogen activator), or platelet GPIIbIIIa (alpha IIb beta 3) inhibitors (abxicimab [ReoPro], tirofiban, aggrastat). Also, factor Xa inhibitors, can alter PT, PTT and Lupus anticoagulant results.

Dr. Ben Blend, Bozeman Deaconess Laboratory Services clinical director, is available for consultation and can help you decide the efficacy of testing patients under differ-ing circumstances, including those who may be receiving anticoagulation therapy.

Labby

Dear Labby: A patient of mine recently presented with a deep vein thrombosis (DVT) after a long airplane ride and is being treated with Coumadin. I feel the patient needs to have a thrombotic risk profile performed, but wonder when would be the best time to obtain the testing.

Sincerely, A Concerned Doctor, of Course

Documents

IN THE LAB - Cloudinary...Once again, Jen Gummer, MT (ASCP) CLS (NCA) of Boze-man Deaconess Laboratory Services has issued a challenge to fellow laboratorians and phlebotomy employees