Theranos Under FDA Scrutiny
The Empowered Healthcare Manager: Why people get fired
Product Spotlight: CE Day
Ernst Appointed to CLSI Council
This month in Phlebotomy Today
Survey Says: Butterfly usage
What Should We Do?: Foot deformities and heelsticks
Tip of the Month: Ten truths about syringe draws

Theranos Under FDA Scrutiny

In the January issue of this newsletter we introduced you to Theranos, an upstart company in Palo Alto, California with potential to revolutionize the laboratory industry. Many other publications, including Smithsonian, have heralded the company as revolutionizing healthcare by being able to perform 30 tests on a single drop of capillary blood at a fraction of the cost of conventional testing.

Last month, the company's administrative offices---mere minutes from the San Andreas fault--- were rocked by shockwaves in the form of an FDA investigation and a scathing expose in the Wall Street Journal. According to subsequent articles in Fortune Magazine, the Wall Street Journal, and dozens more, the privately held company, valued at 9 billion, faces scrutiny for possibly cheating on its proficiency tests, failing to respond to complaints, producing inaccurate test results, and misrepresenting the nature of its testing. Theranos denies the claims.

The New York Times reports Theranos's proprietary Nanotainer, the device the company has been using to collect capillary samples, is not an approved medical device. On October 16, the  Wall Street Journal reported Theranos stopped collecting blood samples in the device under pressure from the FDA. Theranos said it was voluntary, and still use it for one of their FDA-approved tests.

On October 28, the FDA released two reports citing "observations" from unannounced visits from August through September. The reports cite issues with internal audits of its quality management system, inability to document their suppliers met the qualification, and concerns that their proprietary Nanotainer was made from materials supplied by unqualified suppliers. Theranos says every observation has been corrected.

The Empowered Healthcare Manager:  Why people get fired 

Every month, Phlebotomy Today-STAT! reprints one of the prior month's posts to The Empowered Healthcare Manager blog, written by Dennis Ernst. 

Employees are fired for two reasons. Either they choose to sabotage their own employment or they just don't have the skills to do the work. The empowered manager is good at knowing which is at play.

Both require the gentle, compassionate, patient guidance of the empowered manager. You coach them, nurture them, and train them how to keep their job. If they were hired for the wrong task, it ultimately becomes obvious they're just not suited for the work. So you reassign them, if possible, to the position he/she was made for. For those who choose to sabotage their employment, repositioning never works. Don't bother. You'll only poison another manager's well.

Instead, you point out the behaviors that aren't tolerated and the goals that must be met, restate your expectations, clarify the consequences, and monitor for deviations. When the sabotage continues, you push the reset button... again. Make sure the employee knows he/she is choosing to limit his/her potential, not you. Clarify one of your roles as manager is to implement the decisions your staff chooses you to make about their place in the organization. That they are in control of the decisions you have to make. They orchestrate it. They force it. They own it. You just implement.

Empowered managers don't let anyone play the victim.

Subscribe to The Empowered Healthcare Manager.

Product Spotlight:  Phlebotomy CE Day

Do you wish you could complete all your annual CE requirements in one day? Join industry expert Dennis J. Ernst MT(ASCP),NCPT(NCCT) as he presents the Center for Phlebotomy Education’s second annual Phlebotomy CE Day on December 5, 2015 in San Diego. With the interactive dynamics only a live event can provide, Mr. Ernst will deliver four lively presentations worth six P.A.C.E.^® continuing education credits total.

Here's what attendees at last year's CE day in San Francisco had to say about the event:

• "We were in the same room all day and I was NEVER bored!"
• "Wonderful! Loved the conference. Worth the travel and money."
• "I've never enjoyed a class like I enjoyed this one... seriously!"

List of presentations, to register or for more information. Half-day registrations worth 3 CE credits are also available. 

* This event meets California’s Department of Health Services’ requirements for maintaining phlebotomy licensure and for maintaining certification by most certifying agencies. The Center for Phlebotomy Education is approved as a provider of continuing education programs in the clinical laboratory sciences through the ASCLS P.A.C.E. program. Accepted by all nationally recognized phlebotomy certification agencies. All other healthcare professions, check with your credentialing agency. Provider #491. California #0001.  

Ernst appointed to CLSI Council 

Seven members of the CLSI Consensus Council met for an orientation meeting with CLSI officers in San Diego.

Dennis J. Ernst MT(ASCP) NCPT(NCCT), editor of Phlebotomy Today-STAT! was recently appointed to the Clinical and Laboratory Standards Institute's (CLSI) Consensus Council. The 12-member panel has authority over all CLSI standards development activities, including project approval, prioritization, status assessment, and consensus approval for document publication. 

"CLSI is honored Mr. Ernst has accepted the position on the Consensus Council," says CLSI Chief Executive Officer Glen Fine, MS, MBA. "Dennis continues to be a tireless champion for the global establishment and implementation of standardized best practices in all aspects of phlebotomy and related pre-analytical services. His leadership, commitment and expertise continue to have significant impact on the improvement of quality practices in laboratory medicine, and, ultimately, on the health and well-being of patients everywhere.”

Ernst has been actively involved with CLSI since attending an NCCLS seminar in 1996 on the standards organization's newly revised venipuncture standard. "After that meeting I knew this is an organization I want to be part of," says Ernst, "and that this is a standard I want to be involved in." Ernst was chosen to be on the working group that revised the standard again in 2003 and has chaired two subsequent revisions. He has also served on committees revising the industry's skin puncture standard, coagulation standard, sample handling guideline, and a guideline on blood collection tubes and additives. His committee's work on the latest revision of the venipuncture standard is nearing completion and is expected to be released in early 2016.

"It's an incredible honor to be selected from all those who were considered," said Ernst. "The work we have before us is tremendously important to laboratories around the world and every physician and patient they serve."

Other Council members include Mary Lou Gantzer (BioCore Diagnostics), Lucia Berte (Laboratories Made Better), Rex Astles (CDC), Karen Dyer (CMS), Thomas Fritsche (Marshfield Clinic), Loralie Langman (Mayo Clinic), Joseph Passarelli (Roche), James Pierson-Perry (Siemens), Andy Quintenz (Bio-Rad), Robert Rej (NY State Dept. of Public Health), and Zivana Tezak (FDA).

This Month in Phlebotomy Today:
 

Here’s what subscribers to Phlebotomy Today, the Center for Phlebotomy Education’s flagship newsletter currently in its 15th year of publication, are reading about this month:

Feature Article
The Art (and Magic) of Centrifugation

On the Front Lines
Hemolysis in one tube only

From the Editor's Desk
You and the bell curve

Sticks, Staph, and Stuff
The next big threat?

The Empowered Manager
Covenants, conditions and restrictions

Mythbusters
Is slapping the skin the best way to find veins?

What's Wrong Here?
A monthly image to test your powers of observations

Subscribe to Phlebotomy Today and get this issue immediately.

Survey Says:  Butterfly usage

Winged blood collection sets (aka, butterflies): patients love 'em for their miniature size and harmless-sounding name; managers hate 'em for their cost. Last month we asked Phlebotomy Today-STAT subscribers and visitors to our web site how many they used each month and how they handled patient requests for them. Here are the results of the frequency question: 

• I never use butterflies---1.6%
• fewer than five times per week---33.6%
• once per day---6.2%
• 2-5 times a day---25.8%
• 6-10 times a day---13.4%
• 11-20 times a day---3.1%
• More than 20 times a day---3.9%
• Other: 12.5%

The reason for usage varied. Some comments:

• That's all that's used at my job; its a specialty clinic
• I only use butterflies at my pediatric location
• As a trainer I don't collect every day, however I would use 2-3 butterfly collects each day that I work in phlebotomy
• When collecting blood cultures, infants and hand veins.
• My hospital uses only butterflies
• Only when needed for small fragile veins
• Neither I nor my facility are tracking our butterfly use. It has not gotten out of hand for our patient population. Plus in our hospital, nursing (particularly ER) has initiated a practice of double IV's- one for each AC space. So, often we are forced to use butterflies.
• We use butterflies for all blood culture collects, some paediatrics and occasional difficult collects
• The clinic where I work has a pediatric practice, so if I'm drawing a baby, toddler or elementary/ middle school age child, I'm going to use a butterfly.
• I assess an older (teenage) kid's veins and their level of comfort and experience and then determine what equipment is most appropriate to safely and efficiently draw the blood.
• All my draws are done with a butterfly needle. I work for a Pediatric Hospital and that is all that is provided.
• Once or twice a year

When asked how they react to patient requests for butterflies, the responses were split right down the middle. Half said they honor their request no matter what, while the other half said they only honor request when the patients' veins require one. Comments include:

• I always say, "Let me take a look to since I have not drawn you before, and we can go from there."
• We try to talk to patients about our training and experience. We are the experts and need to try to put the patient at ease to let them know what is appropriate and give good explanation as to the "why." If they still insist we use them. It's important to give explanation, but at the end we leave it up to the patient.
• I try to make the draw as comfortable as possible for the patient.
• A good conversation with the patient usually convinces them that I will select the correct equipment for them.
• I will ask them if I can look at their veins first and explain that it is a better sample if I can use regular needle.
• Some patients have had a bad experience with blood draws due to the inexperience of the phlebotomist. I have had patients tell me this and I put on the tourniquet and they have huge veins that can be felt but not seen. We need to teach that the vein has to be felt not necessarily seen.
• I explain to the patient that the butterfly may be a preferred choice for the person that has drawn their blood in the past, but for me the vacutainer system allows me to be successful in acquiring the proper amount of blood and insure a quality sample so we can give their physician results that properly represent their health. This usually helps to educate the patient and make them feel comfortable.
• I explain to the patient the potential consequences of using a butterfly and that it could result in their labs needing to be redrawn.
• The patient/client's needs come first. If they feel insecure or afraid, they might complain or move about while inserting the needle.
• I feel I use them more because of IV placement on the patients leaves me a lot of the time with only the hand to use. Our patients routinely have multiple IV's even if they have nothing running in them.
• I explain to them that an experienced phlebotomist chooses a collection method appropriate to the situation.
• I work in a Mental Health Hospital and try to accommodate anxiety if they request a butterfly
• I find that if I briefly explain to them the importance of a good specimen, in most cases the patient will allow, and be comfortable with, my choice to use or not use a butterfly.
• We use scripting to make sure we are only using them when needed. We are given 1 box a month and typically don't use them all. We have gone on a hunt for waste in our department and found a lot of phlebotomist using them just for the ease and not necessity. If there is a phlebotomist that is using a lot more than needed we used education to fix and re-educate them so they could use a straight needle or a syringe.
• This is a very sticky customer service situation that I have learned to handle over my 23 years. I honor their request no matter what--to a point. I find that often my assessment agrees with their request, but if it is just for a cbc then I will suggest a syringe draw, letting them know the needle is the same size but we just won't have all the tubing. Sometimes it is a matter of fear. I find it is best to answer to that and still use a butterfly but also talk to them about my assessment of their veins, letting them know how good they are and that next time we should try something more appropriate.
• Why make the patient hostile just to use a different kind of needle?
• I give my customer what they want. I want them to be happy with their visit and come back.
• Depends on the patient's personality as far as I can judge it. Sometimes it's better for the patient to feel they have been honoured and sometimes if I explain the vein doesn't require a butterfly, they are content to let me judge.
• I explain to them, that they might not need it etc. If they still insist then I will use one.
• I honour their request but during the collection process will discuss with them the best way forward for them so hopefully 'next time' they will be comfortable with a competent phlebotomist making the best choice of equipment for them. It is a lack of trust in the phlebotomist usually created by a previous bad experience and needs sincere empathy to turn that around.
• Because of customer service surveys going out to all patients, the company that I work for wants high scores, and tries to meet all our patients' needs.
• I will talk to the patient about their previous experiences to determine why they are requesting a butterfly. If they've been traumatized by previous unsuccessful IV starts, I explain why that was different than what we're doing at the moment. If a patient is insistent I won't argue, but talking about their concerns is often enough to instill confidence in them that I know what I'm doing. Having said that, if a patient has an amazing vein and wants a butterfly, and they aren't watching me, I'll use a straight needle instead. If we've established a rapport I'll let them know afterward what I used and why. My goal is always to educate and inform so my patient can have better experiences than they've had in the past.
• I educate the patient that they get a better result with a straight needle.
• Nothing bothers me more than when a patient tells me what kind of needle I have to use on them. Some patients insist that they need a butterfly even when they have huge veins. Just yesterday, a healthy man in his 60s came into the outpatient clinic where I work and completely freaked out when he saw the 22-gauge needle I was preparing to use, insisting he needed the "baby needle" so it wouldn't hurt. I think fewer people would insist on the "butterfly" if it didn't have such a cutesy nickname. I think I'm going to start calling it the "horsefly" needle. :)

This month we're asking about your facility's policy on multiple heelsticks on neonates, if you prewarm every heel, and if you puncture twice initially.

 Take the survey.

What Should We Do?:  Heelsticks on infants with foot deformities

 What Should We Do? gives you the opportunity to ask our team of technical experts for advice on your most pressing phlebotomy challenges. Whether technical or management in nature, we’ll carefully consider solutions and suggestions based on the industry’s best practices so that you and those in other facilities with the same problem can benefit, all the while maintaining your facility’s anonymity. What Should We Do? is your opportunity to ask us for suggestions on the best way to handle your real-life dilemmas.

This month's case study: I was recently approached by a RN in the NICU regarding the heel stick on an infant with a foot deformity. The concern was raised about multiple heel-stick collections on the non-deformed foot, and the proximity of the punctures to each other. I can find no documentation in regards to how any facilities might handle similar situations. What should we do about heelsticks on infants with deformed feet?

Our response: It's not unusual for newborns to be born with foot deformities. One study found the frequency to be around four percent. Eighty-seven percent corrected within 6 years. Common abnormalities include metatarsus adductus (the front half of the foot turns inward), clubfoot, flatfoot (flexible and rigid), and deformities of the toes. Clubfoot occurs in one out of 1240 live births. It has a higher incidence in Hispanics and lower in Asians.

Clubfoot makes positioning the foot difficult, and is associated with poor circulation, which can prevent phlebotomists from obtaining adequate samples. Those who perform heelsticks, however, are not trained to recognize foot deformities. We suggest educating your staff on what clubfoot looks like, and invite a pediatrician to discuss the proper approach to positioning and obtaining blood samples. We have found no information on the risks of heelsticks when drawing from infants with foot deformities, or strategies phlebotomists can use to minimize the risk and obtain adequate samples beyond traditional heel warming techniques. An image of an infant with clubfoot can be found here.

Each month, our “What Should We Do?” panel of experts collaborates on a response to one of the many compelling problems submitted by our readers. Panelists include Dennis J. Ernst, Catherine Ernst and Marijon Geurts, a certified Phlebotomy Technician in New Zealand. who has researched the topic extensively.

Got a challenging phlebotomy situation or work-related question? Email us your submission at [email protected] and you just might see it as a future case study. (Names and identifiers will be removed to assure anonymity.)

Tip of the Month

This month's featured Tip of the Month: 10 Truths About Syringe Draws
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