My Scope of Practice: The Audacity of Determination

  Carelyn P. Fylling, RN, MSN, CWS, CLNC, wasted little time submerging herself in her work. She received her Bachelor of Science Degree in Nursing from North Park College (Chicago, IL), a Master’s Degree in Nursing from the University of California (San Francisco, CA), and became a Certified Wound Specialist and Certified Legal Nurse Consultant.

During the initial years of her career, Carelyn worked as a staff nurse on a surgical station where she was moved by the needs of people with diabetes; subsequently, she developed a comprehensive diabetes education program providing one-on-one patient education, in- and outpatient classes, and outreach programs specifically to address the needs of the diabetic community.

  Following graduate school, Carelyn was recruited to join the International Diabetes Center, Minneapolis, MN. There were not many diabetes educators and nurses were not part of multidisciplinary care teams. Fortunately for Carolyn and her colleagues and patients, she was afforded the opportunity to help establish the interdisciplinary team concept of diabetes education and management. “For 12 years, I consulted on diabetes and patient education nationally and internationally, conducted patient and professional education programs on a state- and region-wide basis, and developed patient education materials,” she says. She consulted with the National Institute of Health and the Centers for Disease Control and Prevention, served on the National Board of the American Diabetes Association (ADA) in addition to serving as Chair of its Patient Education Committee, and served on the ADA Governmental Relations and Public Education Committees. She was instrumental in initiating and securing Medicare coverage for therapeutic shoes to prevent development of diabetic neuropathic foot ulcers. Carelyn was deeply honored and humbled to receive the National Ames Award for Outstanding Health Professional Educator in the Field of Diabetes from the ADA.

  In 1986, Carelyn was recruited to help start Curative Health Services, a biotechnology company that specialized in autologous platelet releasates or autologous multiple growth factors for the treatment of nonhealing wounds (Procuren^®). “During this time, the diabetes world and the wound care world were approaching treatment modalities from very different vantage points,” Carelyn says. “It was exciting to help blend these worlds and influence clinicians in each arena to adopt some of the quality practices from the other.”

  For the past 9 years, Carelyn has served as Vice President of Professional Services for Cytomedix, Inc. (Rockville, MD), a biotechnology company that develops biologically active regenerative therapies for wound care, angiogenesis, and inflammation. Initially, the AutoloGel™ System (autologous platelet-rich plasma gel —PRP Gel) was developed for use in exuding wounds. It harnesses the patient's natural healing processes with the delivery of a platelet releasate gel and contains growth factors, cytokines, and chemokines required for cell growth and formation of new tissue to restore the balance in the wound environment to transition a nonhealing wound to a healing wound. Carelyn has helped develop the PRP gel system as a point-of-care, advanced wound care therapy that is custom-made for each patient.

  One of Carelyn’s many job duties entails overseeing the company’s clinical program, which facilitates evaluation and implementation of the gel as an advanced wound therapy. “I managed the first multicenter, prospective, randomized, blinded, controlled trial on the use of this PRP gel for the treatment of diabetic foot ulcers, the results of which were published in Ostomy Wound Management in 2006,” she explains. “This study was instrumental to receiving FDA clearance for this product’s use on exuding wounds such as diabetic foot ulcers, leg ulcers, pressure ulcers, and mechanically or surgically debrided wounds.”

  Carelyn’s responsibilities also include creating and establishing new initiatives for improved patient care. Her accomplishments include comprehensive wound management algorithms, interdisciplinary care for wound patients, high-quality education and training of wound care professionals, databases to monitor and improve patient care, and hundreds of wound care programs with organized systems for wound care. None were in place when she began her career. “It is exciting to see that these initiatives have become common place in the wound care community,” she says.

  An advocate for professional advancement, Carelyn says it is important to have a vision for the future with quality care and outstanding outcomes for patients as top priorities. She believes working through the healthcare or corporate system is the best opportunity to make such goals possible and has been gratified to put her knowledge to practice in order to influence care quality. “High standards set the tone for the professionalism and quality of service my company is providing,” she says. “As the clinician on the management team, you can have input to set direction and standards for the company, keeping the ultimate goal of healing patient wounds as your focal point.”

  Two of the obstacles Carelyn must face in pursuing clinical goals are helping the medical and/or scientific community accept new treatment modalities and dealing with reimbursement by third party payors. According to Carelyn, new therapeutics typically are not incorporated easily into care plans; the keys to overcoming these obstacles are professionalism, use of solid science, research, and quality clinical outcomes.

  The sweet counterparts to Carelyn’s busy workdays are catching up on the latest Danielle Steele novel or listening to the soothing sounds of Josh Groban and Celine Dion. She also spends her downtime planning her annual winter escape from northern Minnesota to southwest Florida. Carelyn also enjoys crafts and scrapbooking and is currently doing genealogical searches to develop a digital book of her family history. “Heritage means a lot to me and I want to preserve it for my extended family,” she says. “I love fishing and boating and even though I travel extensively for my career, I thoroughly enjoy traveling to new locations around the globe. In the past 3 years, my husband and I have discovered motor home travel. It provides a way for my home and office to be with me at all times while learning from the beautiful people we meet and seeing awesome scenery and unique sites.”

  Carelyn attests to the necessity of instilling hope and confidence in patients that they can be healed in a short period of time and that people with diabetes don’t always need to undergo amputation. One particularly memorable scenario is that of a young paraplegic woman who had an ischial pressure ulcer for 2 years. Even with sufficient care and the use of the latest wound care products, the wound would not heal. The patient’s quality of life was significantly limited due to offloading to try to heal the wound. She could not participate in social activities, her general activity was restricted, and she was in jeopardy of losing her job. “When I met with the patient the night before her first PRP gel treatment, I shared the exciting data regarding the healing rate of diabetic foot ulcers,” says Carelyn. “She asked me if there was any hope for those types of positive outcomes for her. I clearly recall responding with shear confidence, I don’t see why not. That prediction came true. Her ischial pressure ulcer was healed with the use of PRP gel in 4 weeks and she was able to return to her full life.”

  Looking ahead, Carelyn plans to continue designing, developing, and implementing the clinical program for using the PRP gel, developing protocols for using this gel in wound care, conducting outcomes studies, publishing, making presentations, and developing new applications for the product. “I like being a pioneer, designing and developing new things,” she says. “Throughout my career, I have climbed many mountains then turned whatever was developed over to another qualified individual to either maintain or take to the next level. I like to keep moving in order to climb the next mountain. Uncharted territory is not a fear for me — instead, it is a challenge I love to surmount.”

  Carelyn encourages everyone from nurses to clinicians to keep an optimistic attitude. “There is always a way to do things,” she says. “It might take some very creative thinking and hard work, but it can be done— nothing is impossible.” Carelyn utilizes a multifaceted brainstorming approach to tackle her workload, an ideals approach that involves asking the question, What is the most optimal outcome I want from a new initiative? “Dream big!” she encourages. “Once you have your dream in mind, then plug in constraints. By practicing this approach, you usually end up with a better end result as opposed to starting from the bottom and feeling overwhelmed by the problem.”

  One of the most valuable lessons Carelyn has learned over the years is to be open to unforeseen opportunities. “Many times these new opportunities are exciting new adventures in your career and enhance your ability to help patients and their families,” she says. Carelyn embraces opportunities and challenges as they pertain to the best interest of the patient —unyielding determination essential in her scope of practice.

This article was not subject to the Ostomy Wound Management peer-review process.