ORs of Tomorrow Can Yield Pay-offs Today

The operating room (OR) of the future is closer than many facilities think. While the level of sophistication in equipment and technology depends upon a facility’s budget and ability to retrofit to accommodate exciting new developments in OR modalities, facilities should be aware of the changing dynamics of OR design and planning.

The challenges of efficient and effective surgical planning are numerous, according to Charles Martin, AIA, and Lynne Shira, RN, BSN, both principals with the Seattle architecture firm NBBJ, who were part of the Designing High-Performance ORs, a day-long symposium presented by STERIS Corporation last October. Martin and Shira explain that owners/operators of medical facilities must find a way to juggle their increasing equipment needs, technology demands and compatibility issues. They see an upward trend among healthcare facilities in the overall demand for additional space to grow their surgical service lines, including new ORs, procedure rooms and the requisite spaces needed to support these new rooms. Today’s facilities require much greater flexibility in the infrastructure and its operational capacity to accommodate more integrated systems both in and out of the OR. Not only can this flexibility create an environment to better foster staff recruitment and retention, Martin and Shira say, but it can improve the patient experience.

The size of ORs has been increasing over time, with the OR of yesterday being about 400 to 500 square feet, with a total department space of about 2,000 square feet. The OR of today and tomorrow is now an average of 600 to 800 square feet, with a total departmental space between 3,200 and 4,500 square feet. The reason for this expansion can differ greatly from facility to facility, but many institutions are creating hybrid ORs that encompass and integrate surgical and interventional services, imaging and clinical services. This kind of OR can accommodate multiple care-delivery models and new technologies, as well as support clinical and administrative uses.

Fred Bentley, practice manager for syndicated research at the Advisory Board Co., says that ORs have been invaded by numerous “space-eating” technologies, such as PACS, C-arms, endoscopic towers, robotics and inter-operative MRIs. The space around the operating table has become increasingly cramped; an OR of 300 cubic feet frequently must accommodate about 115 cubic feet of surgical and anesthesia personnel and about 150 cubic feet of equipment, leaving just about 35 cubic feet of free space. It can be a struggle for facilities to balance comfort and efficiency, Bentley adds, that an OR of less than 400 square feet is now considered to be an anachronism because of its cramped, inflexible space; the 500-square-foot OR is now a tight fit; and an OR with more than 800 square feet is probably an over-indulgence and has the potential for too much dead space. The sweet spot, Bentley says, is an OR of about 600 to 650 square feet, which has enough space to accommodate equipment, but facilitates enough unimpeded circulation throughout the room. To cope with smaller ORs that cannot be immediately retrofitted, some facilities are opting to move some bulkier pieces of equipment out of the OR, such as a mobile C-arm that can stored in a corridor alcove or an adjacent equipment closet, or using utility booms to get equipment lifted off of the floor. Other facilities are opting for more streamlined integrated interventional suites that come turn-key from manufacturers such as STERIS.

A hybrid OR is quickly becoming a favorite option for some facilities wishing to make better use of their OR space. Neurological surgeon Jeffrey Yablon, MD, of the Lake Norman Regional Medical Center in Mooresville, N.C., defines a hybrid OR as “an actual operating room located within the surgical suite that accommodates uncompromised interventional, open and minimally invasive surgery within a given specialty.” Yablon says that a number of trends are driving the hybrid OR craze, especially recent technological advancements and specialists’ desire to expand their sphere of expertise amidst competing services. Another driver is the limited space with which many facilities must contend; Yablon says a hybrid OR can be used for several services or procedures and will provide maximum utilization of space. Yablon also cites increased competition for procedural services, with cardiothoracic moving into interventional cardiology, interventional radiology moving into vascular surgery and interventional cardiology moving into interventional radiology. Another factor is tighter reimbursement; Yablon says a hybrid OR’s flexibility will allow for this space to be fully used with a continual stream of reimbursement dollars. He adds that increased readiness and flexibility results in fewer complications and better outcomes, which ultimately achieves lower costs and higher profit margins.

Hybrid ORs are a win-win situation for surgeons, Yablon says, because they allow for improved patient care because of integrated technologies, and because they provide room flexibility and improved workflow. Nursing staff members like these ORs because they improve staff productivity, workflow and ergonomics, as well as improve room utilization and reduce scheduling challenges. And administrators like them because they help to retain surgeons and nurses as well as optimize capital monies. Yablon adds that hybrid ORs are not without their challenges – including costs, simultaneous competition for the room’s unique resources among surgeons and the need for continual future upgrades – but says the advantages frequently outweigh the challenges.

One healthcare system that has moved boldly into the OR of the future by embracing cutting-edge technology is the Carondelet Health Network in Tucson, Ariz., whose hybrid ORs boast the BrainSUITE iCT, a dual-room intraoperative large-bore, multi-slice CT with sliding-gantry from BrainLAB. Neurosurgeon Eric Sipos, MD, FACS, medical director of the Carondelet Neurological Institute, says the advantages of a two-room CT scanner system include the minimized disruption of the familiar surgical workflow with a maximized CT scanning range providing the widest range of patient positioning. The surgical table position for scanning can be stored prior to draping to avoid collisions with scanner, and once positioned for surgery, the patient is not moved, especially outside of the sterile air field; the anesthesia is fixed and constant throughout the surgical and imaging procedures. With a sliding gantry moving between two ORs, there might be the opportunity for cross-contamination, but Sipos emphasizes that the preservation of the sterile environment is achieved and the patient in the adjacent OR is not compromised in any way. Carl Colombi, technical consultant with the Integrated OR Solutions (iORS) Division of BrainLAB, says the BrainSUITE fully integrated intraoperative CT surgical operating room can facilitate surgical planning and navigation, as well as achieve data management and coordinated equipment integration.

While this level of technology might be reserved for the larger health systems, ASCs shouldn’t count themselves out of the technology game nor assume they cannot replicate a hybrid OR set-up. “Over the years, we have seen more and more surgical cases migrate to the outpatient environment, primarily due to the advances in anesthetic agents and minimally invasive technologies,” Shira says. “Our previous thinking that an outpatient surgery is for ‘minor’ surgical procedures simply doesn’t hold true any longer. The equipment and technology required for minimally invasive work demands a surgical footprint and boom configurations that are not unlike the inpatient environment. ASCs that want to plan for this technology in the future need to remember this as they are planning.” Shira continues, “Recognizing that ASCs are held to a different building standard than hospitals, there should still be planning for proper air exchanges, good surgical traffic patterns with non-restricted, semi-restricted and restricted zones understood with the design. And of course, there can be no compromise on safety protocols and cleaning protocols regardless of the location of the surgical environment.”

Martin and Shira emphasize that the numerous rapid advances in imaging technology are dictating some OR planning and design elements, and note that many imaging interventions are transitioning from diagnostic to therapeutic, thus blurring the boundaries between imaging and surgery. The goal of many facilities is to integrate these departments into a single service with common support in terms of supplies, equipment and staff. If designed correctly, this concept also can eliminate the all-too-common duplication of pre- and post-operative functions, as well as eliminate the duplication of space, equipment and supply storage. Martin and Shira add that integration of staff with similar skill sets can greatly improve operational efficiencies. The integration concept also can apply to universal procedure rooms that specialists can share, as well as universal prep and recovery areas that can accommodate varying patient volumes throughout the day, as well as minimize patient transfers and reduce the number of supply-distribution points.

While we have seen how the physicality of the OR is evolving for the future, it’s important to note that healthcare professionals are following suit. Bentley points to the trend of surgeons and interventionalists becoming one and the same in the future; in the past, these two groups have performed distinct classes of procedures, while in the present, some surgeons are learning select interventional techniques. In the OR of the future, it may be no surprise to see surgeons familiar with nearly all major interventional procedures and perform them frequently; there may also be the rise of the multi-purpose proceduralist. Bentley says these proceduralists can be co-located on the same floor of a facility, or they can even be housed in the same suite, functioning in what Bentley calls a “multi-purpose sandbox” to accommodate all kinds of disciplines.

No next-generation OR can be planned and executed without buy-in from all stakeholders during the project planning and management process, including surgeons and clinical personnel, administration, the architect, the engineer, the IT department and key vendors, according to collaborators Chris Kantorak, technical consulting manager with BrainLAB, Inc., Brian Hartman, project design manager with STERIS Corporation, and Paul Niehaus, project manager with Philips Healthcare. They say that advanced OR suites require space for technology, personnel and ancillary equipment, and that design input from all user groups must be obtained to ensure an optimal environment for all. More specifically in terms of roles among stakeholders, the architect is responsible for evaluating trends such as fixed-based imaging versus mobile imaging, and OR integration; providing for the expansion to a larger OR footprint ; and understanding the changes in sterility needs when going from an imaging suite to a flexible hybrid OR suite, for example. They must also design into the OR future flexibility, such as empty conduits for information/video routing, blank structural plates and positions to accommodate new equipment in the future. To this end, the equipment manufacturer can help plan for the support of new technologies as they are added. In turn, the vendor plays a key role by helping to maximize functionality and the placement of multiple technologies, offering design expertise with proper sequencing of design needs, and planning for both existing and future technologies or evolving clinical procedures.

Safety & Flexibility: Alcon Intrepid Polymer I/A Tips

Released by Alcon in late 2009, the Alcon Intrepid Polymer I/A tip has brought a sense of increased safety and flexibility into cataract procedures.  Although, not as soft as the Alcon silicone I/A tip, this polycarbonate material still provides the same safety in allowing to polish the capsule and maintaining the integrity of the capsular bag.

In addition to not only providing safety through its design, it is also a “true” single use device that is disposed of after each case thusly reducing potential factors (such as residual, cortical material)  that could attribute to TASS.  The tips come in three configurations, a straight, 20 degree soft curve, and the 35 degree bent tip.  Each of the tip configurations has a .3mm aspiration port and the flange design to allow for proper placement of the sleeve. All of the tips are fully compatible with the threaded Ultraflow handpieces and with all MicroSmooth sleeves.  The Intrepid Polymer I/A tips are unique and quality products to add to any cataract surgeons procedures.

Kaiser questions complexity of drug-safety programs

Kaiser Permanente is concerned that too many diverse drug safety programs will impose a burden on the healthcare system and on patients, and that this will drive up costs and limit access to therapies.

The integrated health plan wants a greater say in how the Food and Drug Administration (FDA) and drug companies design and implement these programs to ensure they don’t discriminate against certain healthcare providers and pharmacies.

In 2007, Congress expanded FDA’s authority to require drug makers to establish Risk Evaluation and Mitigation Strategies (REMS) to enhance the safe and appropriate use of marketed medicines. Most of the 80 or more approved REMS are fairly modest, only providing patients with printed medication guides that describe proper drug use.

But a growing number of these programs also include more extensive Elements to Assure Safe Use (ETASU), which tightly manage prescribing and dispensing of high-risk medicines. ETASU can involve limited distribution of the drug and certification of prescribers and pharmacists to ensure appropriate prescribing and dispensing; in some cases patients have to be tested to ensure they’re not pregnant, for example, or that the drug is not causing harmful reactions.

COST AND ACCESS QUESTIONED

Kaiser is concerned that its physicians and pharmacies will be cut out of such certification and distribution programs, and that its patients will have difficulty gaining access to needed therapies. Such requirements could increase costs for health plans and for consumers, limiting access to needed drugs and the overall benefits of the REMS safety program.

The problem has not been that noticeable so far because most REMS with ETASU have involved drugs for relatively small patient populations. However, FDA is considering a more involved REMS for the broad class of extended-use opioids, and might weigh such an approach for erythropoietin-stimulating agents (for red blood cell production), drugs that are expensive and widely used.

Consequently, Kaiser has formally petitioned FDA to open up its process for designing and approving REMS with ETASU. Kaiser proposes that FDA’s public advisory committees review such processes to make the proposals more transparent and to allow plans and providers to have a say. That would give Kaiser an opportunity to have its own specialty pharmacy operation included in a REMS network.

The health plan also wants to ensure that REMS programs protect the privacy of patient health information.

Clinical consequences drive the need for pharmacy integration

THE INTEGRATION OF pharmacy and medical data has gone a step further into the coordination of services. A whitepaper published in March 2009 by several pharmacy organizations attributes a new focus on collaboration to an uptick in clinical consequences and costs of medication misuse and non-adherence; a shift from acute to chronic care; the increasing role of pharmacists; and the growing number and complexity of medications.

“Coordinating pharmacy and medical benefits paints a total picture of compliance without a gap in data, and thus, impacts outcomes,” says Nita Stella, senior vice president, ActiveHealth Management, a care management company headquartered in New York City. “In addition, sharing information can increase medication safety and effectiveness by triggering alerts to flag drug-to-drug interactions, contraindicated drugs and non-compliance.”

Integration is an effective vehicle for identifying high-risk members and putting value-based benefit design into place. For example, an integrated system could identify high-risk members and lower copayments for those individuals or for an entire class of drugs, such as stains, to encourage compliance.

David Dross, leader of the managed pharmacy practice for Mercer Inc. in Houston, says that integration is easier if one vendor is managing both sides of the equation. While he believes that a carve-out pharmacy is willing to share its data, he says the medical vendor could be the “fly in the ointment” because there may be a fee attached to the provision of data.

The Clinical Pharmacy Cardiac Risk Service (CPCRS) at Kaiser Permanente Colorado combines KP HealthConnect, an electronic health record (EHR), with an electronic care registry, proactive patient outreach, wellness and medication management.

After high-risk patients for coronary artery disease are identified, they are referred to CPCRS. The program has served 21.000 patients since 1998.

“We are able to determine who has a cardiovascular event and deliver continuity of care cost-efficiently by integrating pharmacy and nursing teams with patients and their doctors and using technology and other tools to address problems,” says Jon Rasmussen, chief of clinical pharmacy, cardiovascular services. “Primary care physicians and cardiologists spend an inordinate amount of time with chronic care patients, so we’re looking for ways that pharmacists and nurses can relieve some of the burden. If these cardiac patients are managed consistently through collaboration, that frees up physicians to address acute issues.”

Results show the number of those meeting their LDL cholesterol goals increased from 26% to 73%, and screening for cholesterol rose from 55% to 97% during an average length of participation in the program of 2.3 years.

In addition, participants in the CPCRS program had an 88% reduced risk of dying from a cardiac-related cause when enrolled in the program within 90 days of a heart attack.

When members are close to release from the program, Kaiser Permanente rehabilitation nurses set up phone calls to discuss diet, exercise, depression, smoking cessation and medications. In a seamless process, Rasmussen says, after discharge, participants work closely with clinical pharmacists for long-term medication management.

Although the program has been successful by saving lives, reducing hospitalizations and recouping investment, it hasn’t been without its challenges. Among them have been getting clinicians to communicate via the EHR, developing multifunctional teams and making sure that “we target the right person with the right treatment at the right time,” he says.

THE FOUNDATION OF INTEGRATION

CIGNA is another insurer that relies on pharmacy to reduce medical costs through evidence-based medicine.

“Data sharing between the pharmacy benefit manager and the insurer is the foundation of integration,” says Claire Marie Burchill, vice president of strategy, product and marketing for CIGNA Pharmacy Management based in Bloomfield, Conn.

Many of CIGNA’s pharmacy programs demonstrate integration with the medical side with an emphasis on adherence. Although they are pharmacy-related, they have a large impact on medical cost reductions, such as emergency room visits and hospitalizations.

CIGNA’s Outcome Improvement Programs, which combine the use of prescriptions drugs, disease management and behavioral coaching, saw results in 2008:

• a 74% medication adherence rate led to 50% of those in the cholesterol program reaching their goals;
• a 78% decrease in LDL and the avoidance of 262 heart attacks annually saved $6.6 million;
• a 34% increase in use of drugs for treating asthma led to fewer emergency room visits and hospitalizations, cutting costs for participants by 50%;
• an adherence rate of 84% for diabetes drugs resulted in 13% fewer emergency room visits and 18% fewer hospitalizations; and
• a 35% increase in completion of depression treatment plans realized an 18% reduction in medical and behavioral healthcare costs.

Dovetailing with the program is CIGNA’s new CoachRx, an interactive Web site to enhance medication adherence with home delivery. A self-assessment helps members identify barriers to adherence and allows them to request daily reminders for self-care.

Those who need additional assistance can call toll-free for medication coaching sessions with a clinical pharmacist, who works with case managers. The coaching team will help find the most appropriate and cost-effective medications for a member, discuss possible side effects and reinforce the importance of taking prescribed medications as directed.

“In this way, we have used one intermediary to maximize health,” Burchill says.

To address high-cost drugs with the potential for side effects and infections, CIGNA offers TheraCare, a medication therapy management program targeting individuals using specialty injectable medications for 16 chronic conditions, such as multiple sclerosis.

“We still have a way to go in integrating pharmacy and medical benefits because the Rx benefit is administered in silos,” says Steve Mullenix, senior vice president of communications and industry relations for the National Council for Prescription Drug Programs (NCPDP). “Medicare Part D’s Medication Therapy Management Program is a step in the right direction, but we are still trying to buy drugs as inexpensively as possible without knowing the impact of the full picture. The right hand doesn’t know what the left hand is doing.”

For example, if a pharmacist dispenses a drug but it’s not refilled, that requires communication so that some action can be taken to encourage compliance.

Mullenix, whose organization focuses on developing consistent standards is concerned that without standardization, it will be difficult to create interoperability between proprietary systems.

“We are a proponent of a team approach to healthcare, including patients and pharmacists, who have become medication experts and need to be reimbursed for their guidance,” he says.

The Building Blocks of Patient Safety

Patient Safety Awareness Week is March 7-13, 2010, and this observance is always a good opportunity to review the patient safety initiatives you currently take at your ambulatory surgery center (ASC), as well as ask yourselves what you could do to take safety to the next level. I like what Doni Haas, RN and Lorri Zipperer, MA, have created in their “ABCs of Patient Safety” to remind healthcare professionals of common-sense ways to protect patients. With kudos to Haas and Zipperer and the National Patient Safety Foundation (NPSF), here are the ABC’s they recommend:

Accountability is not always about a person.

Blame hides the truth about error.

Cultures must change.

Document facts.

Error is our chance to see weakness in our systems and people.

Focus on prevention.

Gather evidence to support facts.

Hear when you listen.

Investigate cause.

Justice should include compassion, disclosure and compensation.

Knowledge must be shared.

Learning from others’ mistakes benefits all.

Make the effort to look beyond the obvious.

Nothing will change until you change it.

Opportunities for solutions are lost by blame.

Partner with patients and practitioners.

Question until you can no longer ask “why?”

Reporting error is suppressed by blame.

Systems are where practitioners practice.

Think about the blunt and sharp end.

Understand the role of accountability.

Value the patient’s perspective.

Why, Why, Why, Why, Why = root cause.

X-ray vision sees the deeper story.

You can make a difference.

Zeroing in on cause brings us one error closer to zero error.

For more resources, visit the NPSF at www.npsf.org.

Source: Haas D, Zipperer L. ABCs of patient safety. Focus Patient Safety. 2000;3(1):3.

Mock Surgery day

The 19^TH Annual Mock Surgery day at Brackenridge Hospital was a huge success. Approximately 1500 people attended the event. A wide variety of groups and organizations were represented as they shared information on various topics pertaining to good health and general safety. Those who attended learned about subjects like; kidney disease, diabetes, cancer, fire safety and more. The hospital also had staff on hand to show people how to bandage wounds and even the trauma department was represented.

Vantage Outsourcing was invited to participate in the event and for the first time ever cataracts were covered. Information was shared, which answered a variety of questions, such as:

• What is a cataract?
• How does it form?
• Who can get cataracts?
• How long does the procedure take?

Along with this information, the cataract surgery was described, the surgical instruments were on hand for viewing and some of the different types of lens implants were discussed. Overall, a lot of information was provided.

Vantage Outsourcing had a great time at this public event and is looking forward to further the publics knowledge when it comes to Cataract Procedures.

Steroids helpful for DME

For patients with diabetic macular edema (DME), intravitreal triamcinolone (IVTA) was able to improve vision in eyes that had continued to deteriorate despite receiving standard laser treatment, researchers at the University of Sydney, Australia, said in a university news item.  In the first three months after treatment, the patients initially treated with both IVTA and laser showed significantly better gains in vision than control group patients who were treated with laser only. After 2 years, patients in the original control group were also treated with IVTA. The beneficial effects persisted in most IVTA-treated patients throughout the 5-year study; however, 80% of patients in the initial IVTA group developed elevated intraocular pressure and 56% of them required therapy, the university said. Also, two-thirds of all patients required during the study period. Similar outcomes have been noted in other studies of steroid-based treatment and thus were not considered new safety concerns by the group.

Biologics can treat some cases of inflammatory bowel disease

INFLAMMATORY BOWEL DISEASE (IBD) includes ulcerative colitis and Crohn’s disease, two distinct conditions with similar symptoms, in which the intestines become inflamed, probably as a result of the body’s immune reaction mobilized against intestinal tissue. Ulcerative colitis affects the colon and the rectum, while Crohn disease’s may affect any portion of the gastrointestinal tract (most often the small intestine and/or the colon.) Symptoms typically include diarrhea, abdominal pain, nausea and vomiting, fever and weight loss. Sometimes there are associated complaints such as arthritis or skin problems.

Most patients have sporadic symptoms. About 20% to 25% have frequently relapsing disease, or chronically active disease. Drugs to treat IBD include mesalamine (a substance that helps control inflammation), antibiotics, corticosteriods, and immunosuppressants.

“For patients with mild to moderate disease, initial treatment would depend on their specific condition,” says Bruce Sands, MD, MS, vice chair of the American Gastroenterological Association Institute. “A person with moderate disease might have diarrhea three or four times a day, and some degree of urgency and belly pain, but they can take in adequate nutrition, and they are able to function in daily life.”

However, a significant proportion of patients, perhaps 15% to 20%, do not respond to conventional treatment. The introduction of tumor necrosis factor (TNF) inhibitors in 1999 dramatically altered treatment for these patients.

These medications are biologic substances that can locate and bind to the specific molecules involved in causing inflammation. Today, three TNF inhibitors are approved by the FDA for treatment of moderate to severe Crohn’s disease that has not responded to other drugs: Cimzia (certolizumab pegol), Humira (adalimumab), and Remicade (infliximab).

Remicade is also approved for treatment of moderate to severe ulcerative colitis that has not responded to other therapies. Tysabri (natalizumab) a monoclonal antibody, has been approved by the FDA for treatment of moderate to severe Crohn’s disease that has not responded sufficiently to other treatments.

“TNF inhibitors were a completely different type of agent that could produce a response in patients who had been refractory to all existing therapies,” says Dr. Sands. “Before the advent of TNF inhibitors, I had patients who were completely homebound by the disease. Not every patient responds, and some have a partial response, but in many cases patients were able to return to work and a normal lifestyle.”

These medications have side effects, which may include the risk of infection or rare cases of lymphoma, says Dr. Sands. When patients have mild symptoms, typically those medications are not recommended.

MAKING CHOICES

MCOs often rely on a prior authorization process for TNF inhibitors.

“We provide a number of options for members who have IBD, and we ask them to work with their physicians for a choice of agent,” says Brian Sweet, PharmD, MBA, chief pharmacy officer for WellPoint.

At WellPoint, pharmacists answer front line calls for prior authorizations and work with physicians to obtain documentation.

“If appropriate documentation is not met, then [the request] is sent to a medical director for medical review.” he says. “The medical director is the only person who can actually determine that the claim would not be paid or that the prior authorization criteria are not met.”

The prior authorization criteria WellPoint uses for TNF inhibitors for IBD treatment are aligned with FDA recommendations and the organization’s medical policy.

“Remicade is the only biologic approved for treatment of ulcerative colitis,” says Sweet. “If the doctor demonstrates the patient has not responded to conventional treatments, then Remicade would be approved for ulcerative colitis.”

Humira, Cimzia, and Remicade have been approved for Crohn’s disease, and Tysabri has been approved for moderate to severe Crohn’s disease that has not responded to conventional therapies or to TNF inhibitors

“There are significant safety concerns with Tysabri, related to the risk of PML [progressive multifocal leukoencephalopathy], so in that case there is an additional step edit,” says Sweet.

Sometimes the claims are paid as a medical claim, and sometimes as a pharmacy claim. Criteria must be consistent to ensure consistent access across the organization, he says. Specialty pharmaceuticals often are placed in the highest tier of the formulary and require the highest out-of-pocket costs.

“That’s because we want to ensure an appropriate amount of member coinsurance, so they understand the expense of these agents,” says Sweet.

Coinsurance for these medications is about $50 on average, although it may vary widely across different benefit designs.

This article is based on information supplied by The Medical Letter ( www.medicalletter.org), a non-profit organization that publishes newsletters offering critical appraisals of new drugs and comparative reviews of older drugs. The Medical Letter is completely independent of the pharmaceutical industry. It is supported entirely by subscription sales and accepts no advertising, grants or donations. Institutional site license inquiries can be sent toinfo@medicalletter.org. [info@medicalletter.org.]

FDA prioritizes drug safety, expects industry to be proactive

Early last month, the FDA launched the Safe Use Initiative, which aims to create and facilitate public and private collaborations within healthcare to reduce preventable harm associated with medication misuse, errors and other medication-related problems.

Through this initiative, the FDA hopes to improve upon current approaches, many of which were put in place over the last century as reactionary measures to specific needs or emergencies.

“Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems.” says FDA Commissioner Margaret A. Hamburg, MD, “The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries.”

Specifically, the initiative plans to unite federal agencies such as the FDA, Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control (CDC) and Drug Enforcement Agency (DEA), together with professional societies, pharmacies, hospitals, drug developers, manufacturers and distributors, as well as patients and their representative organizations in order to manage medication risk.

“All participants in the healthcare community have a role to play in reducing the risks and preventing injuries from medication use.” says Janet Woodcock, MD, Director of the FDA’s Center for Drug Evaluation and Research.

At present, millions of Americans require prescription and/or over-the-counter (OTC) medications to improve or preserve their health; with as many as 3 billion prescriptions written annually. As a result of this vast use of medications, it is estimated that at least 1.5 million preventable adverse drug events occur annually, resulting in hundreds of thousands of injuries and deaths.

Adverse events from medication use have been linked to more than 4 million visits to emergency departments, provider offices or other outpatient settings and greater than 100,000 hospitalizations each year. According to FDA officials, “many injuries associated with medication use could be prevented with currently available knowledge.”

In fact, current estimates suggest anywhere from 11% to 50% of injuries could be preventable.

During the initiative’s first year, the FDA plans to implement a small number of safety programs. Some key interventions include evaluating consumer medication information; communicating the risk of overexposure to acetaminophen; safeguards for alcohol-based surgical preparations and avoiding contamination of multiple use medication vials. FDA intends to hold a series of public meetings to gather feedback.

Teamwork and Talent Drive the ASC of Union County

Teamwork is a way of life for the 21 staff members and 50 physicians at the ASC of Union County, a two-OR, multi-specialty, physician-owned ambulatory surgery center in Union, N.J. At the heart of that teamwork lies a commitment to patient care that exceeds expectations and a family spirit that pervades everything at the center, which opened in 2000. And helping to drive that commitment are two individuals who work as the facility’s dynamic duo — Marcy Sasso, director of operations, and Debbi Holley, RN, BSN, director of nursing.

Nominating the duo for this year’s Who’s Who in Ambulatory Surgery is Glenn Davison, DPM, FACFAS, a board-certified podiatrist who is one of the owners of the center. He credits Sasso and Holley with leading the team to a number of notable achievements, including growing the physician pool and the center’s staff while cutting costs and increasing collections, as well as driving down the infection rate and causing patient satisfaction scores to skyrocket.

“Recruiting physicians is always challenging for any ASC,” Sasso acknowledges. “In New Jersey there are 300-plus ASCs so that translates into most doctors having their own place. We were fortunate in retrospect that our area hospital closed; we hired an outside marketing person to assist with recruitment. In 2008 we were at 80 percent capacity of our 7 a.m. to 3 p.m. block time so that marketing ended. Since then I found that word of mouth to other doctors was really our best means of recruitment. We have had several requests for credentialing packets every month for the past two years. I have a nice marketing packet put together that includes a brochure with our owners’ information, a physicians guide, all of our specific booking forms and criteria, information on our center from transportation to patient instructions, not to mention the give-aways such as letter openers, rolodex cards, sticky notes and pens. We also market all of our credentialed physicians on our Web site, and we place their business cards in our waiting room. When they come to tour the center we promote cross referrals and they meet with one of our financial coordinators to assist in educating their patients about our billing procedures.”

Building relationships is also key to working well with a diverse group of patients, physicians, colleagues, payors and vendors, and Sasso says the secret is “letting each person bring their unique talent and personality to work everyday. Really believing in their talents and bringing out their strengths that may have been dormant.” She adds, “The clinical staff here by far makes a lasting impression on our patients. The patients are greeted with a warm smile and often leave with a great cup of coffee and a hug. Our three administrative staff members multi-task as if they were a team of five and always with a smile and a kind word. They always look for ways to improve patient care and outside office communications.”

Sasso says that what she and her colleagues enjoy about the ambulatory care environment in part is the autonomy allowed by the center’s owners. “It allows Debbi and me to use our creativity, common sense and charitable side to run the ASC of UC so efficiently,” Sasso explains. “Being a smaller facility, we are able to cross-train and be a part of every day-to-day occurrence here. We have the opportunity to get to know our patients and they get to know us. Debbi and I don’t have to micro-manage in any way because when you come to an ASC setting you know you become part of a team and most days we consider our team our second family. It’s a positive and enthusiastic environment that one won’t find in the hospital setting.”

The ASC made a true believer out of Holley, who says, “My background was always in a hospital setting and the fear of joining an ASC was quite scary. I always believed that ASCs took away business from the hospital. When the local hospital closed, I had no choice but to jump in feet first to an ASC. I now see that the ASC has a warm and relaxing atmosphere. Nurses have enough time to spend with their patients to make them feel comfortable. They can have that idle chit-chat and not feel rushed to get onto the next patient.” Holley continues, “ASCs make it easier for the patient from arrival to discharge. Since our OR scheduling is close to or on time, patient scheduling is more convenient for patients and their family members. The patient has a specific OR scheduled time and they come in, their family member can sit with them in pre-op while waiting to go into the OR. After their procedure, the patient is offered coffee or juice cookies or muffins, then they go home. The patients feel more relaxed and comfortable before going in for their procedure and leave in a positive state of mind for a successful recovery.”

Sasso says the center’s team spirit and reliable retention rate are attributable to a number of factors, including treating everyone with fairness, equality and honesty, promoting a true open-door policy, as well as mentoring, coaching and supporting each other.

“A center can only work as well as their team,” Holley says. “To me, I am only one piece of the pie. Without the other pieces, there would be no pie. I feel that I would not be able to run a smooth and efficient center when one piece is missing. Our consistent reputation and positive work environment is cause for employee retention and terrific patient satisfaction. Positive feedback to the staff for all that they do on a daily basis is essential. No one wants to hear only the negative things that happen during the day.

“We also have pride and ownership, and we celebrate our successes,” Sasso says. Those celebrations of success range from an annual holiday party and bonus to a family picnic, staff birthday celebrations and a staff appreciation day, plus employment perks such as a retirement plan, paid health coverage and continuing education for all staff members.

The center had much to celebrate when they achieved accreditation with the Accreditation Association for Ambulatory Health Care (AAAHC). “Due to Marcy’s and Debbi’s leadership, we have received the highest accreditation from the AAAHC for a three-year term,” Davison says.

“Accreditation was something we had been putting off for several years for fear of the unknown,” Sasso explains. “When our medical director, Dr. Thomas Ragukonis told us we were ready and deserved to be in this prestigious category we took his suggestion and plunged in. During the pre-accreditation process we were able to review and improve many of our ‘stale policies.’ We split into sub groups to tackle the process; empowering all staff to take ownership along the way. We repaired some cracks in our foundation and Debbi wrote 65 new policies and re-vamped more than 100. Our staff philosophy has been treating each day as if the inspection were to happen and there is no need to worry when it does. Our two-day survey was intense and thorough, as they ought to be, and during our exit interview they told us that ‘we should be very proud of what we do here’ and we were rewarded with a three-year accreditation. Going through the process was an outstanding learning experience for all staff. Now we routinely review the assessment manual to be sure we keep this prestigious accreditation.”

Davison says that Sasso and Holley “believe in and promote continuing education, and every staff member has attended at least one or more courses last year. All staff members take the BLS course and all of our nurses take the ACLS course which we sponsor right here in the center.”

It is this focus on patient safety that has propelled the ASC of Union County in everything it does, including making ambulatory care the best option for healthcare professionals and patients.

“It is proven by all of the benchmarking statistics that ASC’s provide a cost-effective, top-notch setting for patients as opposed to the standard hospitals,” Sasso says. “The physicians feel that the latest technology is more available here and we are more patient-friendly. The doctors are able to perform more cases in one day here than they would be able to in the hospital. ASCs don’t have the ‘I am a number’ mentality, and patients are referred to by name and are remembered when they return for an additional visit. The infection control rate of most centers is 1 percent or less, and hospitals cannot offer that same optimistic statistic. (Ours, over the past eight years, is less than 1 percent). ASCs typically have better control of the flow over their patients, less red tape than a hospital from the registration process to the patient discharge much faster and fewer mistakes!”

Holley concurs, adding that ASCS must be prepared to face unique clinical challenges such as patient safety practices, especially proper identification. “What we do here is at registration, the patient is asked for the last four numbers of their Social Security number, birth date and a picture ID,” she explains. “In the pre-op area, the patient again is asked for their last four digits of their Social Security number, their birth date, what procedure they are having and where will be the incision site will be. The last four numbers of their social security number is on their identification band. This same list of questions is asked again during the consent period. Another challenge is having the patient bring in a list of medications that they are currently taking in order to complete the medication reconciliation at their time of discharge. Both the nurse and physician must sign the completed form at discharge. ASCs may find identifying the correct patient and information a little more difficult than in a hospital setting but with our process in place, we have not encountered any problems. We feel confident that we have the right patient here for the right procedure.”

Holley says that the ASC enhances patient satisfaction through positive encouragement and communication. “During our pre-op admission we instruct the patient that their discharge instructions and survey is in their envelope and hope that they will help us serve our community better by their comments. When patients are discharged we know something about them and we make a mention about this to let them know we heard them. We wheel or walk out every patient and wish them well. By the time they are leaving at least four people have said goodbye to them. We encourage patients to send back the survey when we make our next day post-op calls. We treat every patient as if they were a family member from start to finish.”

Holley adds that the ASC’s low infection rate is another accomplishment. “The most important part of keeping infections down is hand hygiene,” she says. Nurses must wash their hands immediately before and after touching a patient to prevent cross-contamination. We have constant monitoring; we have a full-time RN trained in infection control who runs in-services and is routinely changing signs in the patient/visitor areas. We also book 15-minute intervals between cases to clean and sterilize the ORs between cases.” Holley adds that in order to prepare for impending inspections, the ASC has a staff member do spot checks to ensure handwashing is done properly, and they also conduct mock surveys frequently to observe and educate staff on potential problems.

Contributing to the ASC’s clinical success is staff’s investment in the center and in their work. “I think ‘team’ and ‘ownership’ are the two words that describe our staff,” Holley says. “Each staff nurse has a specific job that they take ownership of. One nurse will be in charge of all the contracts for the center; it is her responsibility to update expired contracts on a monthly basis. Another nurse is responsible for the QA projects; she does monthly audits and chart reviews. Another staff nurse is responsible for keeping abreast of any OSHA problems and updates. This nurse will give monthly reports on any OSHA criteria. The nurses feel a sense of pride and accomplishment in their specific area. We also have two OR techs in nursing school and the other RNs take time to mentor them.”

Bringing staff together is the ASC’s quality assurance program, which also serves to audit physicians and their time in the OR. “Many book a case for a specific amount of time, and we are detecting some run-over in their allotted time and push other physicians back in their start time,” Holley explains. “This leads to physician and patients becoming frustrated with wait time. To improve patient satisfaction, we need to determine which physicians need extra allotted time for certain procedures. Dialogue between physicians and staff has improved by having an open communication policy. Physicians are asked on a monthly basis if anything needs to be improved or if they need a specific piece of equipment. The physicians educate the staff on procedures that are new or unfamiliar, and physicians allow any staff nurse to observe their cases. And during monthly staff meetings, they are encouraged to think of new ideas to make the center run smoothly.”

“Our staff enjoys coming to work and seeing the patients get well and leave happy,” Davison confirms.

The ASC staff echo this sentiment. Clinical coordinator Kathy Melnick, RN, BA, CCRN, emphasizes, “I have been a nurse for more than 40 years and I have never worked anywhere where the patient satisfaction surveys have come back with such glowing accolades; from the admitting process to the discharge, every staff member tries to make the patient stay as pleasant as possible. The staff prides themselves on a professional, compassionate and friendly demeanor which is demonstrated on a daily basis with every patient. A great percentage of our patients are repeat customers and we hear over and over again how they only want to come here for their procedures! It is an honor for me to be associated with a surgery center that provides exceptional patient care for the surgical patient.”

Jan Marsh, RN, says she appreciates the center’s dynamic environment. “Having worked in a hospital setting for most of my professional career, transferring to the ambulatory setting was a new experience for me. I truly enjoy the atmosphere at the ASC, which is professional yet patient friendly. The doctors and nurses work together as a team to deliver the best possible patient care for every individual.”

One of the center’s orthopedic surgeons, Clifford A. Botwin, DO, observes, “I don’t ever remember any institution receiving the accolades and satisfaction from patients, families and staff that have been attributed the ASC of Union County. Led by an outstanding administrator, Marcy Sasso, and staff this facility although relatively small has been in the forefront of community health and relations in our area.”

The center believes that participating in philanthropic efforts is a worthy way to give back to the community.

“Marcy organized and brought in more than 3,000 brand new toys for the local police holiday drive, and had more than 10 pallets of medical and child care items sent to Louisiana for Hurricane Katrina-related needs,” says Davison.

The local community in central New Jersey also benefited from the center’s generosity through its free health fair held last year.

“Our physicians came out in full support of this endeavor, with more than 15 doctors representing various specialties were available for the over 350 attendees,” says Mary E. Koch, RN, BSN, CNOR, the center’s OR supervisor. “In light of our current healthcare situation, there are many people who have no access to healthcare. This provided a unique opportunity for the public to speak with a physician. This is one of the many wonderful ways we care for our community, from Toys for Tots, Katrina relief supplies, Walk for Autism, and breast cancer awareness. I am proud to work in a surgery center that gives so much to the community in addition to the exemplary care we provide for our patients.”

“At our community health fair we saved and changed more lives in that one day than any of us ever expected,” Sasso says. “I believe you get what you give, so giving back was our motive for the health fair. The local hospital used to put on a health fair and since they closed several years ago the community was no longer afforded that special day. It seemed like the perfect opportunity to market our ASC and give back at the same time. It took just two days to get a commitment from our 15 owners, and we had six weeks to organize the fair. I called every one of our vendors, every local non-profit group, the blood bank, physical therapy, imaging centers, and the local chamber of commerce. The ‘give back’ message took hold with them and we had an overwhelming response. We had our 15 doctors on site talking to the public about their specialties — orthopedics, GI, general surgery, bariatric, pain management, podiatry, gynecology and chiropractic — as well as body fat screenings and all the give-aways a visitor would hope to find at a fair. We had 350-plus guests, gave away four glucomoters, took 185 blood pressure readings, and had 11 blood donors. Giving is so contagious, you can’t help it sometimes. That fair was one of the greatest achievements in my career.”

To read more about the ASC of Union County’s involvement in ASC advocacy and politics, don’t miss the January 2010 issue of SurgiStrategies.

Q&A with Marcy Sasso

What can other ASCs do to emulate the success of your center?

If ASCs strive to continually evaluate their actions and decisions in light of patients’ best care and treatment, they will automatically discover the path to success. Make safety your No. 1 priority, and put it on the agenda for every committee meeting. Monitor your patient surveys closely, as they will be valuable assessment tool; share them with all of your staff and physicians. Our surveys have been outstanding with some wonderful comments regarding our exceptional staff and comfort of our ASC, and 100 percent of our patients have indicated that they would return should the need arise. When we saw a comment about discharge instructions, we immediately held a brainstorming meeting and made a change as to when and to whom instructions were given. If an employee has drive and ambition, take a look at how they can bring additional value to the center. For example, Lauren, our OR tech, mentioned that it would be great to be an OR nurse and really admired our RNs. Mary is now her mentor while she is going to nursing school in the evenings. Our staff attends conferences and we encourage them to share their knowledge. Look inside your team, as you may find the next surgeon just waiting to be mentored!

How do you stay current in the industry?

I read at least nine trade publications weekly, and I have signed up for every “alert” there is. I attend the annual ASC conference and send many of my staff to specialty courses. I forward at least three or four “FYI” e-mails to my center’s owners on a weekly basis to be sure that they are kept up to date in the ASC world.

Next Page »