The National Association of Healthcare Quality (NAHQ) proudly established Healthcare Quality Week as a dedicated time to celebrate the profession and raise awareness of the positive impact these professionals have in their organizations and communities. According to NAHQ, “healthcare quality professionals are no longer the best-kept secret in healthcare,” and at Orsini, we couldn’t agree more wholeheartedly. In honor of Healthcare Quality Week, October 16th – 22nd, we asked several key team members to share their focus on ensuring quality in every aspect of Orsini’s work, from training and compliance to regulatory and operation, and invite you to enjoy highlights of their thoughtful discussion below.
Our Orsini experts bring more than 60 years of collective experience to their roles:
Lynn Black, Chief Operating Officer: earned Pharmacy and MBA degrees and has more than 30 years of experienced leadership growing and transforming businesses in the home infusion, specialty pharmacy, long-term care, and rare disease/orphan drug marketplace.
Kathi McDonell, Quality and Compliance Manager: 13 years at Orsini, leading quality teams since 2017.
Lisa McCulloh, Quality and Training Manager: earned an MBA and certification as a pharmacy technician. Has 15 years in the pharmaceutical industry, including working with manufacturers on clinical studies, training, document development, review, and drug launches.
Q: How has your role at Orsini evolved over the years to keep up with ongoing changes in quality requirements and standards?
Lynn: I look at the concept of quality as a driver of continuous performance improvement throughout the company. There’s an aspect of quality in everyone’s job that’s vital to be recognized as a leading independent specialty pharmacy. As it relates to operations, quality is the most essential component. You can’t have one without the other; if you’re running operations without focusing on quality, you won’t be in business very long. They are truly completely intertwined. At Orsini, we’re constantly in a cycle of earning new accreditation or gaining reaccreditation according to even higher quality standards. We focus on continually upgrading processes, systems, and training to meet new requirements.
Lisa: Over time, the Quality & Training department’s responsibilities have expanded due to the industry’s enhanced accreditation standards and the launching of new therapies, requiring the development of new processes in tandem with detailed standard operating procedures (SOPs) for employees to train on and follow. We maintain our company’s core set of SOPs, which must be reviewed and updated each time a change in accreditation standards occurs or other new requirements must be met. Because we’re a closely monitored industry, this can mean updating and training employees on up to 50 SOPs annually for accreditation bodies, including state agencies, ACHC, URAC, the Joint Commission, and the National Boards of Pharmacy.
We’re also part of the product launch team now, ensuring required training documentation and leading the development of new therapy protocols and call guides. These documents help our therapy teams understand everything needed to compassionately service our patients and dispense the new therapies according to manufacturer and accreditation quality requirements. With Orsini dispensing more than 50 high-touch therapies, the Quality & Training department stays busy ensuring our ever-growing therapy teams receive all initial and annual training. While our quality efforts focus on monitoring agencies’ requirements, what drives us is the ultimate goal of a positive patient, prescriber, and manufacturer partner experience with Orsini.
Kathi: Without a doubt, manufacturers’ and payors’ quality requirements have ramped up considerably in just the past few years. The FDA has become more demanding with drug manufacturers, which in turn means their requirements of us have also become more vigorous. Drug manufacturers, accreditation organizations, and health insurance companies are now looking for highly detailed information, constant collection of data, and documented process improvements.
We also interact regularly with state boards of pharmacy in all 50 states and the District of Columbia to ensure our compliance with licensing and regulatory requirements. Additionally, we audit 30 to 50 claims per week to ensure that we correctly dispense medications following the prescribers’ instructions and the health insurance payors’ plan requirements. And we are constantly providing education to our team members on quality processes to ensure these requirements are met and that patients are provided with the best care possible.
Q: What do you feel is most satisfying about working in quality at Orsini?
Lynn: There’s nothing more important than prioritizing quality when delivering services to our patients and interacting with prescribers and vendor partners. I find my greatest satisfaction in working to improve our training and compliance programs and our processes continuously. When those work well, the happier your patients are, the happier your prescribers and manufacturer partners are about your services and what you provide.
Lisa: One of the best parts of my job is partnering with our internal departments to help ensure our documents match our processes (and vice versa) and that both meet our multiple requirements. Next is ensuring that our Orsini program managers, patient care coordinators, pharmacists, admissions representatives, and others receive training on these documents and pharmacy processes. It’s very satisfying to support keeping everyone up to date on their training to ensure all required training documentation is available at a moment’s notice for an audit or other agency review.
Kathi: Striving for excellence in every part of the job with the ultimate goal of positive patient outcomes and the satisfaction of our multiple healthcare industry partners is what motivates me. I feel enormous satisfaction knowing that upholding high-quality standards makes a difference in our patient’s lives and our relationships with physicians, insurance companies, and the manufacturers we serve.
Q: Can you share some of your plans to further drive quality forward at Orsini in the future?
Lynn: Defining our path of continuous improvement for the future will include gaining increased recognition from our current accreditations, including URAC (a leading nonprofit accreditation organization), Accreditation Commission for Healthcare (ACHC) with Rare Disease Distinction, National Boards of Pharmacy, and the Joint Commission. We’ll always seek out new certifications and accreditations that are important for our business.
Lisa: When I started at Orsini three years ago, we had 125 employees, and now we are almost 300. Our business is growing quickly as we partner with more manufacturers and dispense more high-touch therapies — it’s wonderful! But it also means many new hires each week who need training on company SOPs and other role-based curricula, so we will continue to streamline our efforts and automate our processes wherever we can. We also have a planned SOP integration project and other useful process update implementations to help facilitate our accreditation processes.
Kathi: Our patient-facing team members at Orsini already have a lot on their plates. We want to make operational processes as simple as possible for them while remaining compliant with a myriad of legal, regulatory, business, and accreditation requirements. Continuous monitoring, data collection, evaluation, and creative problem-solving are crucial in attaining the best combination of quality and efficiency. I am excited to be a part of that effort with internal and external stakeholders, working toward the ultimate goal of providing better outcomes and higher satisfaction for both our patients and partners.
For more information on how Orsini works to ensure quality every step of the way for pharmaceutical manufacturers, payers, healthcare providers, and patients connect with a member of our team. Since 2009, Orsini, a leading specialty pharmacy, has helped patients with rare and complex conditions receive therapies and validates its ongoing diligence for the clinical, dispense, and home care nursing pharmacy services provided through national accreditations, including URAC, ACHC, the Joint Commission and the National Association of Boards of Pharmacy.