New Products Empowering Patients to Draw Their Own Blood
The road to a cheap, accurate, single-drop blood test is paved with peril. The Theranos meltdown is a classic example of how not to introduce "revolutionary" technology. But two companies are plodding forward methodically, cautiously, and with an abundance of due diligence, something Theranos overlooked.
Athelas (Mountain View, California) is empowering patients to draw their own fingerstick blood and test it for white blood count, neutrophils, lymphocytes, and platelets in the comfort and privacy of their own home or office. According to an article in Bloomberg, the goal of Athelas (named after the healing herb in The Lord of the Rings) is to enable cancer patients who rely on frequent blood draws to monitor blood cell counts, to know when it's time for another round of chemotherapy in advance. Because WBC counts are required to monitor the timing of chemotherapy dosages, patients who can get an accurate count at home can save themselves an unnecessary trip should their count be too low for their next dose. Saving cancer patients from unnecessary trips to their oncologist saves them not only the inconvenience, but prevents their exposure to community-acquired pathogens when they are the most vulnerable.
Athelas was founded by Tanay Tandon and Deepika Bodapati, dropouts from the University of Southern California, who claim their portable blood analyzer can run a complete blood-cell count from fingerstick blood. The patient performs her own fingerstick, touches a card to the drop of blood, inserts the card into the testing device, and receives the results in sixty seconds. According to the article, the point-of-care testing device is a black cylinder resembling Amazon's Echo device. The founders expect FDA approval this year, which will allow them to sell the device over the counter directly to consumers. It is their hope oncologists will recommend the device to their patients to help coordinate their care and bring down costs.
Another company, Seventh Sense BioSystems (Medford, Massachussetts), just launched the TAP (Touch-Activated Phlebotomy) device which extracts capillary blood into its patented device virtually painlessly for transport to testing facilities. TAP was showcased at last month's Global Summit on Best Practices in Preanalytics. and featured in the March 2017 issue of this newsletter.
Liability Insurance for Phlebotomists
What Should We Do?: Curbside draws
Dear Center for Phlebotomy Education:
Our collection centers will draw blood while the patient remains in their car when walking is difficult for the patient. Under these circumstances, can the used needle, with safety device activated, be taken back into the building and then placed in a sharps container? Or must the used needle be placed in a sharps and then carried back to the building?
In its Bloodborne Pathogens Standard, OSHA states that contaminated sharps shall be discarded immediately or as soon as feasible in containers that meet the requirements set forth in Section 1910.1030(d)(4)(iii)(A)(1) (Contaminated Sharps Discarding and Containment). No exception is made for the location of the draw.
In the same section, the standard further states that containers for contaminated sharps shall be easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. OSHA clarified this in 2007 in a Letter of Interpretation.
So, for phlebotomists performing curbside draws, they need to have collection supplies, including sharps containers, available at the point of use. They also need an appropriate secondary container to transport blood samples from the car into the facility. A phlebotomy tray equipped with needed supplies including an appropriate sharps disposal container would meet OSHA's requirement for the immediate disposal of used sharps, and provide an acceptable means for blood specimen transport.
Got a challenging phlebotomy situation or work-related question? Email us your submission at WSWDpanel@phlebotomy.com and you just might see it as a future case study. (Names and identifiers will be removed to assure anonymity.)
Preanalytical Answer Book Filling Void
The Lab Draw Answer Book (Center for Phlebotomy Education, Inc.) has been out only two months and is already filling the void in the libraries of healthcare professionals around the world.
Dennis J. Ernst signs a copy of The Lab Draw Answer Book at the recent Global Summit on Best Practices in Preanalytics.
The response has been overwhelming," says Dennis J. Ernst MT(ASCP), NCPT(NCCT), who coauthored the book with his wife, Catherine Ernst, RN, PBT(ASCP)CM. "It's probably the most successful product launch in our company's history."
The 440-page full-color reference book answers nearly 400 commonly asked questions on blood sample collection and handling, and managing phlebotomy services and personnel. It's the second edition of Blood Specimen Collection FAQs, which was released in 2008, with 100 new entries and all original entries updated to fully reflect CLSI's new venipuncture standard.
Chapters in the book include:
- Safety and Infection Control
- Training, Management and Certification
- Skin Punctures, Heelsticks, and Pain Management
- Patient Identification, Vein Selection, & Site Prep
- Tourniquets & Butterflies
- Order of Draw & Discard Tubes
- Hemolysis and Potassium Issues
- Blood Cultures
- Labeling and Post-venipuncture Care
- Line Draws & IV Starts
- Processing, Storage, & Transportation
- Patient Injuries & Complications
- Unorthodox Techniques
Copies are available from the Center for Phlebotomy Education. More information and preview pages.
Standards Update: Non-conforming events
The newly revised venipuncture standard released by the Clinical and Laboratory Standards Institute in April, 2017 is the most comprehensive revision in the document's history. With over 140 new mandates, facilities have a lot of changes to implement. This series discusses one or more substantive changes each month.
How are policy or procedure violations handled where you work? If you are a manager, what is your protocol? Do you have one that's well established, or are corrective measures randomly applied?
According to the newly revised CLSI standard, a nonconforming event (NCE) management program must be in place in every facility. Deviations from approved phlebotomy procedures must be investigated, documented, and classified, and remedial action taken. All deviations are significant and require implementation of the plan, but especially for:
- errors in establishing patient identification
- using an improper protocol when labeling samples
- failure to follow the established procedure when collecting, transporting, handling and/or processing samples
- customer service incidents
- safety violations
- confidentiality breaches
Implementing a NCE management program isn't only required when a patient is actually misidentified, a sample mislabeled, or confidential patient information leaked. It's prudent even when a procedural deviation doesn't result in an error. For example, if a phlebotomist labels a tube before it is filled when the facility's policy restricts labeling until after it is filled, it's an NCE even if correct label is applied because the procedure was performed improperly. If a computer screen projecting a patient's sensitive data is left unattended and potentially accessible to those who had no need for the information being projected, it's an NCE even if nobody saw the screen.
By implementing a facility's NCE management plan for such near-misses, the facility is taking proactive measures to prevent catastrophic consequences. It's the difference between being proactive and being reactive, between preventing an injury or breach and managing the damages from one.
To comply with the standard, an NCE management program must identify all problem-prone processes, improve the process to prevent the error, implement process and procedure changes, and acquire administrative support to eliminate the cause of the NCE.
Editor's note: Readers are urged to obtain their own copy of the standard as soon as possible and begin implementing all new provisions as soon as possible. The document, Collection of Diagnostic Venous Blood Specimens (GP41-A7), is the standard to which all facilities will be held if a patient is injured during the procedure or suffers from the consequences of an improperly performed venipuncture.
Read an interview by CLP Magazine with Dennis J. Ernst MT(ASCP), NCPT(NCCT) about the revised standard.
From the Editor's Desk
Listening. Creating. Empowering.
That sums up what we spend the majority of our working day doing here at the Center for Phlebotomy Education. It's a tag line at the end of our streaming videos, on our web site, and in many of our publications.
It's not just a cute, catchy marketing slogan. When I think of every activity my staff and I conduct in the course of any given day, we're either listening to healthcare professionals with their questions or problems by phone, email, or in person, creating educational products and materials to solve their preanalytic frustrations, or empowering them with information, inspiration, confidence, and hope to change the culture where they work.
Here's a classic example of our tag line functioning in practice. Recently a laboratory supply company came to us and asked if we'd produce a laminated card that healthcare professionals could attach to their ID badge as a reminder to follow the order of draw and to handle blood tubes properly. After several conference calls and multiple email exchanges (listening), we produced a design that they loved and had thousands printed and laminated for their catalog (creating). Because we've just added it to our catalog as well, they'll soon be distributed in healthcare facilities and academic institutions around the world by managers and educators who need the message they contain reinforced in practice (empowering). (The Order of Draw Badge Tag, is this month's Product Spotlight.)
Here in Indiana, the leaves have turned and are falling. The colors are gorgeous, as the trees go dormant for the winter in a blaze of glory. I don't rake leaves anymore. I stopped a long time ago. I don't live in a subdivision where I have to keep my yard as nice as those of the the neighbors, lest I be scowled at and gossiped about. Nor do I live where there's an association with covenants, conditions and restrictions about such things. I live deep in the woods surrounded by my own forest where nobody cares about my leaves---of which there are many. Myself included. My leaves fall on the ground and stay there until either the wind blows them into the woods or I mow them into mulch that disappears into the fescue.
Nice looking yards are overrated. Once you adopt that perspective, life gets a lot easier. Besides, I've got plenty of things I'd rather be doing than raking leaves on a Saturday, anyway. Take today, for example, which finds me alone in the office writing your newsletter. Listening. Creating. Empowering. Raking leaves accomplishes neither.
On a personal note, not a month goes by when I'm not stunned into disbelief by the perceptions that still persist about drawing blood samples. If you have a moment, follow me....
Dennis J. Ernst MT(ASCP)
Global Summit Raises the Bar
The Global Summit on Best Practices in Preanalytics, the first of its kind, raised the bar for preanalytical seminars last month in Charlotte, North Carolina, USA. Over 100 laboratory managers and educators gathered from around the world to discuss the universal problems plaguing laboratories and healthcare systems including safety, sample quality, staying fully staffed, managing the generational divide, training obstacles and managing change.
Moderated by Dennis J. Ernst MT(ASCP), NCPT(NCCT), a faculty of 11 industry authorities delivered twenty presentations in plenary sessions and breakouts. Two breakout tracks, one for management issues and the other for technical topics, were offered. Three plenary sessions discussed the new provisions of the recently revised CLSI venipuncture standard (GP41-A07), strategies for achieving consistently high patient satisfaction scores and change management.
On the final day, five members of the Global Summit faculty comprised a panel to discuss the international problem of staffing shortfalls among preanalytical personnel. In his opening comments as the panel moderator, Ernst shared the latest industry estimate of an 8 percent vacancy rate for phlebotomy departments, the highest of all laboratory professions. With the average hourly wage of $15.72 (U.S. Bureau of Labor Occupational Outlook), Ernst suggested low pay is only one of many reasons preanalytic personnel leave their positions, and challenged the panel to provide proven solutions attendees could implement in their facilities to secure longevity in their staff. Besides low hourly wages, panelists cited burnout, working short-staffed, inter-generational friction, poor leadership, the lack of a voice in workplace decisions, and bullying. The list of strategies and solutions from the panelists include:
An international audience attends the first annual Global Summit on Best Practices in Preanalytics in Charlotte, North Carolina last month.
- Articulate the importance of the role preanalytical personnel play in the laboratory and in patient care;
- Build trust with your staff so they know you have their backs;
- Get out of the office frequently to talk to the staff;
- Establish and enforce a Code of Conduct;
- Empower employees to speak up when they see problems;
- When adding new tasks to the staff, make it "workload neutral" by removing or reassigning something else;
- Perfect the hiring process by:
- assessing the individual's level of energy
- submit the applicant to a typing test and an attention-to-detail test
- releasing low performers within 30 days
- affiliate with phlebotomy schools with high-caliber programs and instructors
- develop a mentoring program with willing and trained preceptors
Attendees at the Global Summit were primarily from North America, but included representation from the U.S., Canada, South Korea, Finland, Austria, the United Kingdom, and Columbia. The event was produced by Greiner Bio-One and sponsored by the Center for Phlebotomy Education, Seventh Sense BioSystems, Drucker Diagnostics, and Retractable Technologies.
Clips of some speakers can be viewed on the Greiner Bio-One Facebook page. For information on next year's Global Summit, contact Greiner Bio-One by email at email@example.com.
Product Spotlight: Order of Draw Badge Tags
Do those who draw blood samples in your facility realize the order of draw is critical to accurate results, or do they think it's a myth? If they think it's a myth, the Center for Phlebotomy Education can help dispel it.
First, print our PDF titled Do I have to Follow the Order of Draw from our Free Stuff web page and post it where everyone who draws blood can see it.
Secondly, distribute our Order of Draw Badge Tag to your staff to attach to their ID badge so the order of draw is always in front of them. The Order of Draw Badge Tag graphically depicts the order of draw and explains why it's necessary. On the reverse are nine tips on proper tube filling and handling including:
- Fill all tubes according to the proper order of draw
- Mix all tubes with a gentle inversion 5-8 times, 3-5 times for citrate tubes
- Never combine the contents of two tubes
- Fill all tubes to the manufacturer's fill line
- Never refrigerate tubes to be tested for K+ prior to centrifugation
- Allow serum tubes to clot upright for 20-30 minutes prior to centrifugation
- When filling tubes from a syringe, always use a safety-transfer device.
The Order of Draw Badge Tag is printed in full color and laminated for durability. Each 10-pack contains 10 identical copies of the card for distribution to phlebotomists, nurses and all on staff who draw blood samples.
More information and to order.
The Empowered Healthcare Manager: When employees fire their managers
Every month we run an excerpt from our editor's popular blog, The Empowered Healthcare Manager.
Every time someone leaves your employment on their own accord, but stays in the area and the field, they've fired you as a manager.
Sure, people change employers for a variety of other reasons, but if they don't relocate and don't change professions, it should be a red flag. You've got to ask this question in the exit interview: what could I have done to keep you?
If their departure was for more money, don't sweat it. Chances are the difference is sizable and a chasm beyond which you can bridge. But nobody changes jobs for a dollar an hour more unless there's something else you're not providing.
Phlebotomy staffing is one of the most difficult skill sets to maintain in healthcare. Most labs have a revolving door in the phlebotomy department, and struggle to find and keep qualified personnel. If you're losing your best to other employers in the same community and industry, something you can control is probably causing the exodus.
Not everyone will be frank with you when you ask "what could I have done to keep you," but not asking only keeps the revolving door spinning.
Subscribe to the Empowered Healthcare Manager.
Tip of the Month: The Path of Least Resistance
Click here for this month's featured Tip of the Month from our rich library of archived Tips.