The following is a clinical research study conducted by VeniSTAT, Inc.  

Implementing Novel Venipuncture Stabilization Technologies to Improve Patient and Worker Safety and Satisfaction

Abstract

Healthcare professionals responsible for drawing and processing patient blood and biological specimens are faced with many unique challenges during the course of their work, most notably ensuring a successful first attempt at accessing a patient’s vein while protecting themselves and their patient against occupational injury.  First attempt success improves quality and comfort and can be compromised by patient movement, increasing not only the degree of venous access, but also increasing the risk of a needlestick injury.  According to our research, when using venipuncture arm stabilization technology (LabPro™ by VeniSTAT™ Inc., San Diego, CA), first attempt success and patient satisfaction improve, and the risk of occupational injury (repetitive motion and needlestick) can be reduced. 

Introduction

Accessing veins for intravenous therapy or blood sampling occurs more than 2.7 million times each day in the US alone (1,2).   Current techniques require a patient to remain seated in a chair with their arm held outward in a self-supported, hyperextended position.  Without a means of stabilizing a patient’s arm in a chair, the phlebotomist often times will assist in stabilizing the patient’s limb using their non-dominant hand.  In this compromised position, any unexpected patient movement inevitably creates a hazardous environment for both the healthcare worker and the patient. 

The hazards associated with patient movement can range anywhere from a failed first attempt to an increased risk of exposure to an accidental needlestick.  The LabPro™ is designed to stabilize a patient’s arm to reduce unwanted movement during venipuncture.  This research was designed to analyze the effects of the LabPro™ device on first attempt success, healthcare worker safety, and patient comfort. 

Needlestick Injury

The Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (BPS) (29 CFR 1910.1030) requires employers to evaluate and implement engineering controls that protect employees from exposure to blood, body fluids, and other potentially infectious materials that can cause occupational injury, illness, or infection.  According to national aggregate data reported by the International Safety Center’s Exposure Prevention Information Network (EPINet®), more than 10% of all sharps injuries and needlesticks occur during the collection of blood or a patient specimen. Other than disposable syringes (21.3%) and suture needles (24.4%), devices used for blood and specimen collection (winged steel needles, needles on blood collection tubes, lancets, etc.) make up the largest percentage of injuries (~9.5%).  (Ref: EPINet 2015) Since there is a stigma associated with a needlestick and many healthcare workers believe these types of injuries “come with the job”, published literature estimates that half of all injuries go unreported therefore it is critical to identify the sources of these injuries so they can be prevented (3).

Ergonomic Injury

Ergonomic injury continues to impend the health and safety of all healthcare workers and is the result of improper body mechanics.   Often times the healthcare worker compromises his or her body mechanics to accommodate the patient or procedure.  With regards to phlebotomy, proper training dictates that the phlebotomist should perform venipuncture either sitting or standing in an upright position, never leaning forward, with their working field approximately at elbow height.  Without proper support, the phlebotomist is forced to lean or bend over the patient during the procedure in an effort to stabilize and secure the patient's limb during venous blood draw.  Many of the phlebotomists surveyed in this study reported excessive back pain from having to lean or bend over the patient in order to hold and secure their limb during venous blood draw.

According a 2011 report published by the Occupational Safety and Health Administration (OSHA),

[O]n average, U.S. hospitals recorded 6.8 work-related injuries and illnesses for every 100 full-time employee. That is almost twice the rate for private industry as a whole.  In 2011, U.S. hospitals recorded 58,860 work-related injuries and illnesses that caused employees to miss work. In terms of lost-time case rates, it is more hazardous to work in a hospital than in construction or manufacturing. “Days away from work” include only the more severe injuries, and they do not account for injuries where an employee continues to work, but on modified duty.  The Bureau of Labor and Statistics (BLS) reported in 2011 Nearly half (48 percent) of injuries resulting in days away from work are caused by over-exertion or bodily reaction, which includes motions such as lifting, bending, or reaching. These motions often relate to patient handling. (OSHA, Worker Safety in Your Hospital).

First Attempt Success

Successful intravenous access can vary from patient to patient and requires skill and proper technique of the Phlebotomist in order to achieve what is known as first attempt success.  Patient re-sticking as a result of an unsuccessful first attempt can create anxiety for both the patient and the healthcare worker.  Patient anxiety, morphology, age, weight, nationality are all factors that can potentially influence the outcome of any venipuncture procedure.  It is estimated that 28% of adults and 44% of children between the ages of 3 and 10 years will be re-stuck as the result of an unsuccessful first attempt at venous access (5).   If a patient demonstrates a fear of needles, often times the patient will flinch or pull their arm back as the open needle approaches their limb.  According to the National Institute of Health (NIH) 1 out of 3 adults and 2 out of 3 children have an inherent fear of needles (6).  Hamilton suggests that a fear of needles can be associative whereby it is the result of a traumatic event or an inherited vasovagal reflex (7).  The basilic, cephalic, median cubital, and dorsal hand veins are commonly utilized during venous blood access and are often not much larger than the hypodermic needle used to access them.  As a result there is a small margin for error and unwanted limb movement only increases that margin.   

Patient Comfort

Since the implementation of the Affordable Care Act (ACA) of 2014, patient satisfaction scores are weighted against the total reimbursement amount hospitals will see as compared to the traditional “fee for service” model.  As a result, more attention has been given towards patient satisfaction.  Historically, venous blood collection has scored near the lower end of the spectrum with regards to patient satisfaction (8).   Lalongo suggests that pain, anxiety and discomfort are commonly felt by the patient at times when the phlebotomist is unsuccessful on their first attempt at venous access (9).

Methods

The LabPro was installed at two separate sites in 2016, a large (400+ bed) non-profit hospital located in San Diego, CA and a for-profit commercial patient service center (PSC) or clinical laboratory located in West Hills, CA.  Both sites were selected based on the volume of patient visits (minimum of 100/day) and the ease of access and follow-up with the participating staff.   In an effort to limit any bias between public and private managed healthcare centers, public and private healthcare sites were chosen.   A single LabPro was installed at the hospital’s outpatient laboratory for 21 consecutive days.  Hours of operation at the hospital site was 7 days per week, 24 hour per day.  Similarly, a single LabPro was installed at the PSC for 30 consecutive days, or approximately 3528 hours.  Since the PSC was not open 7 days per week for 24 hours per day, the approximate numbers of hours that the LabPro was available for use during this study was 1440 hours.

Phlebotomists at both sites were encouraged to freely rotate between using the LabPro and a traditional blood draw chair for their routine blood draw procedures.  During this study, the total number of participating phlebotomists at the hospital site was 9 phlebotomists: 5 full time phlebotomists and 4 part time phlebotomists.  Whereas the total number of participating phlebotomists at the PSC site was 5, all were full time.

 Upon using the LabPro, phlebotomists were instructed to provide each patient with a voluntary survey.  Each survey included 1 multiple choice and 2 “yes” or “no” type questions with an open comments section at the end (Below).

Voluntary Patient Survey:

(1)    How many needlestick attempts until your vein was successfully located?  One, two or three?

(2)    Would you request to have the “Arm Support” device used during your next visit?  Yes or no?

(3)    Did the “Arm Support” device increase your confidence in the person drawing your blood?  Yes or no?

(4)    Additional Comments:

Patient survey data was collected and results tabulated.

At the completion of the study, participating phlebotomists were given three questions to answer in relation to the increase or decrease in: ergonomics, safety, and productivity as the result of using the LabPro to collect patient blood samples (Below).

Phlebotomist Survey:

(1)    Did the LabPro add ergonomic value?

(2)    Did the LabPro increase your ability to stabilize the patients’ limb?

(3)    Did the LabPro make you feel more protected against accidental needlesticks?

Phlebotomist survey data was then collected and results tabulated.

Results

An estimated 700 patients had their blood drawn using the LabPro at the hospital site.  Of those patients, 10.7% or (N=75) completed the voluntary survey.   First attempt success was achieved at a rate 95% (figure 1).  With regards to the device, 67% patients reported that they would request the LabPro on their next visit and 59% reported an increase in confidence in the phlebotomist having had their blood drawn using the LabPro (figure 1). 

An estimated 600 patients had their blood drawn using the LabPro at the PSC.  Of those patients, 9.8% or (N= 55) completed the voluntary survey.  First attempt success was achieved at a rate of 98% (figure 1).  With regards to the device, 62% of patients reported that they would request the VeniSTAT LabPro on their next visit and 65% reported an increase in confidence in the phlebotomist having had their blood drawn using the LabPro (Figure 1).

FIGURE 1: Patient Survey Results

    The combined total number of participating phlebotomists from both sites are 14.  Of those phlebotomists, 71.4% or (N = 10) completed the survey.  With regards to patient stability, 84% of the phlebotomists surveyed reported an increase in their ability to stabilize the patients’ limb (Figure 2).  With regards to safety, 32% reported an increase in protection against accidental needlesticks (Figure 2).  With regards to ergonomics, 53% believed that the LabPro added ergonomic value (Figure 2).

    FIGURE 2: Phlebotomist Survey Results

      Discussion

      Overall, having a device engineered to stabilize a patient’s limb during venous blood collection increases safety, productivity and patient satisfaction as opposed to not having one at all.  Without stabilization the patient’s limb is more likely to move.  When the patient’s limb moves, the chances of first attempt success are dramatically decreased, the probability of occupational injury goes up and the chances of ergonomic injury due from leaning over the patient to regain control are also increased.   The phlebotomist survey data indicates that the majority, 84%, felt they had more control with the LabPro whereas only 32% felt more protected against occupational injury. 

      Perceived safety can be the result of many different factors.  Patient compliance, patient population, and phlebotomist tenure are all factors that influence perceived safety against occupational injury.  An extended trial period at both sites, may have increased the likelihood of encountering less compliant patient population with an increased risk of occupational injury.  Intuitively, the ability to stabilize a patient’s limb with a device and not their own hand will safeguard them from potential accidents.  On particular phlebotomist exclaimed, “If the patient didn’t have something to hold onto, she would have pulled away and the needle would have pulled out.”  Another phlebotomists said, “When you give the patient something to hold onto, they are less likely to pull away.” 

      As a result of this study, we have found that giving the patient something to hold onto yields high probability of first attempt success, 95% and 98% at the hospital and PSC sites, respectively, and increases their comfort level.  Over 50% of the patients surveyed had such a positive experience with the LabPro that they would request to have it available on their next visit.  We believe this is the result of having something available to hold onto that gave them a sense of control and an increased confidence in their phlebotomist, also over 50% at both sites.    Under the additional feedback section of the survey, one patient wrote, “I liked having something to hold onto.”  Another patient claimed, “The holding bar gave me extra support,” and “it felt more stable.”

      This study suggests that routine use of the LabPro and its ability to stabilize a patient’s limb during venous blood draw will have a positive effect of patient satisfaction when used in other facilities.  It also increased first attempt success and as such may subsequently decrease the risk of ergonomic injuries associated with human factors and repetitive motion associated with current means of venipuncture.  As patient movement is reduced, the institution of an engineering control like LabPro may subsequently decrease the risk of needlestick injury and potential occupational exposure to blood, body fluids, or other potentially infectious materials occurring from blood drawing and specimen collection. 

      Limitations of this study include the use of only one LabPro at each site, the limited number of sites and the absence of a control to compare results against.  

      Overall, incorporating a novel device (engineering control) that stabilizes a patient’s arm (or limb) during blood or specimen collection will have a positive impact not just on patient and worker safety and satisfaction, but also reduce errors, and improve quality.  Looking beyond blood collection, stabilization of a patient’s limb during intravenous therapy or arterial blood gas collection are also areas of healthcare where better engineering controls are necessary to improve patient outcomes and healthcare worker safety.

      References:

      1. Ogden-Grable H, Gill GW. Phlebotomy puncture juncture preventing phlebotomy errors: Potential for harming your patients. Lab Med. 2005;36(7):430–433.
      2. Walsh G. Difficult peripheral venous access: Recognizing and managing the patient at risk. J. Assoc. Vascular Access. 2008;13(4):198–203.
      3. CDC - Stop Sticks: Sharps Injuries – NIOSH.  Available at: https:// www.cdc.gov/ niosh/ stopsticks/ sharpsinjuries.html
      4. OSHA – Worker Safety in Your Hospital: Know the Facts.  Available at: https:// www.osha.gov/ dsg/hospitals/documents/1.1_Data_highlights_508.pdf
      5. Frost & Sullivan, 2009.
      6. Taddio, A., Ipp, M., et al. Survey Of The Prevalence of Immunization Non-Compliance Due To Needle Fears In Children and Adults.  Vaccine. 2012 July 6; 30(32): 4807-12.
      7. James G. Hamilton. Needle Phobia - A Neglected Diagnosis. Journal of Family Practice. 1995; 41 (2): 169–175 REVIEW. PMID 7636457.
      8. Young Rae Koh, MD., Shine Young Kim, MD., et al. Customer Satisfaction Survey With Clinical and Phlebotomy Services at a Tertiary Care Unit Level.  Ann Lab Med. 2014 Sep; 34(5): 380–385.
      9. Cristiano Lalongo, Sergio Bernadini.  Phlebotomy, a Bridge between Laboratory and Patient.  Biochem. Med. 2016 Feb 15; 26(1): 17–33.