Jonathan Davidson M.D.
Advanced Sleep Disorder Centers
Modesto, CA

Clinicians looking to capitalize on the growing sleep field don’t want to wait when it comes to expansion. Fortunately, there are manufacturers that can help.

California’s Central Valley is world famous for its agricultural production, but Jonathan Davidson, MD, believes the area is also fertile ground for sleep medicine. The owner of Advanced Sleep Disorder Centers has so much faith in the burgeoning sleep market that he intends to double his number of sleep labs in 2011—going from three to six.

The fourth lab opened in January 2011 in Merced, California, a county of more than 200,000 people. His fifth and sixth labs will also be located in Merced (labs are located about 30 to 40 miles apart.)

Boosting locations by 100% in one year is powerful evidence that statistical projections for sleep are beginning to match objective reality. Experts predict that a whopping 90% of sleep apnea sufferers are still undiagnosed. Even if the number turned out to be half that, it would still add up to massive demand.

Florida-based Sleepvirtual USA Inc is helping savvy clinicians get up and running quickly to serve expansion growth in the sleep industry. Despite a terrain filled with large competitors, Sleepvirtual continues to grow as a strong challenger in the realm of PSG diagnostic equipment that allows users to record and score unlimited sleep studies.

The BWII PSG sleep system consists of two hardware pieces and a software program that can be used with PC computers running Windows XP, Vista, or W7. The software provides trace and scoring capabilities that are relied upon by users such as Davidson, who says the unit’s portability (under 10 pounds) and accompanying software features and functionalities make it a potent combination.

Customers appreciate the BWII’s price and value, but technical support and financing are the clinchers. Customers are financed internally, and do not need third party financing to purchase equipment. There are various options for the equip- ment: rent, lease to own or purchase choices, which allows price-conscious purchasers such as Davidson to equip their sleep labs without massive cash outlays.

Ultimately, Sleepvirtual’s sales have mirrored the growth of the industry with 2010 sales 60% higher when compared to 2009. “We expect to double our sales in 2011,” predicts Felipe Lerida, CPSGT, customer service manager for Sleepvirtual, Doral, Fla. “I believe our recent growth was due to greater brand recognition, direct referrals from happy clients, and repeat customer purchases. As word spreads, members of the sleep community have no choice but to notice.”

TIME IS OF THE ESSENCE

Seeking to become board certified in sleep medicine? Davidson warns that 2011 marks the last year that physicians can take the board exams without first completing a fellowship. The state boards exams are in November 2011, but there is still time to study.

For board certified physicians who wish to expand or open a new lab, Sleepvirtual’s equipment can be leased (prices vary) to avoid large capital outlay. “As far as training employees,” says Davidson. “The American Association of Sleep Medicine [AASM] has a 14-step training module that works well.”

As a sleep lab owner for the past decade, Davidson particularly likes that Sleepvirtual offers free lifetime technical support every day for as long as he owns the equipment. A live person is always available to answer the phone when he needs them, which is not always the case with larger manufacturers. “We have had problems with reps at major companies,” says Davidson, who opened his first three California sleep labs in Stockton, Sacramento, and Modesto. “At other manufacturers, reps get fired and they can’t replace them. Sleepvirtual is a privately owned company that is more interested in giving you personal service. Acquisition of data is easy, validation is easy, and the way the hardware is designed makes it simple to work with. The electrode headbox is light, and it’s a fraction of the size of its competitors.”

A colleague referred Davidson to Sleepvirtual, who eventually contacted the company to try a 1-month trial product. He liked what he saw and eventually ordered two BWII PSG sleep systems for his Stockton lab, replaced four machines in Modesto, and by the time he outfitted his Sacramento facility he had a dozen Sleepvirtual sleep systems (all of which are subject to free upgrades.)

EASING STICKER SHOCK

Lerida knows that many qualified physicians suffer from sticker shock when it comes to start-up expenses. In many ways, the old axiom is true, “you have to spend money to make money.” However, he says that hardware expenses do not have to be so burdensome.

“Physicians must be aware of initial upfront costs and look for solutions to minimize operating and staffing expenses,” says Lerida. “Physicians and lab owners should start off by looking for affordable and reliable equipment. We provide a fully AASM-compliant Type 1 PSG diagnostic system at the most competitive price in the market. We allow customers the option of in-house financing to alleviate additional finance charges that may be incurred by other companies, along with 24/7 free tech support both via telephone and remote internet.”

Too often, physicians assume all services are the same, but Lerida points out that companies vary in regards to length of extended warranty and technical services offered. “Sleepvirtual offers the most cost efficient extended warranty package, unlimited reading and scoring software licenses, and a 24-hour backup guarantee in case of any hardware issues for the life of the equipment,” says Lerida. “When it comes to financing, the Sleepvirtual’s philosophy is one specifically built for cash-strapped labs. Bank financing often takes months to get approved, but at Sleepvirtual internal financing is quicker and just as effective. So far, no customers have been turned down.”

THE BWII PSG FEATURES AT A GLANCE

• Score on the run which allows users to split the screen during the acquisition and start scoring the same study you are recording.
• Sleep statistic window which automatically gives updates on the AHI and other parameters in real-time.
• All necessary menus for recording a PSG on the same screen.
• Montages, filters, sensitivity, and speed of the page adjustments with the quick mouse click and keyboard options.
• One exam for one file for ease of transferring, copying, and e-mailing (HIPPA Compliant).
• Exclusive technology allows users to have the system working anywhere when the team moves around to different locations.
• The system can be used for acquisition in one location, be scored somewhere else and interpreted by the physician in a third place, it can also be archived in a completely different location.

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For more information about the BWII PSG sleep system, visit http://www.sleepvirtual.com

There are millions of people in North America alone who have an undiagnosed sleep disorder, but how do we identify them? A new entry from the world’s largest sleep diagnostics company aims to fill the preliminary investigation niche that can help identify new patients who may need a full PSG test.

The latest offering from Embla, makers of the familiar REMBrandt™, RemLogic™, and Sandman® PSG systems, is designed to identify the undiagnosed masses who have so far eluded treatment. Dubbed SleepImage™ for its ability to capture a total picture of sleep, CEO David Baker hopes to use the product to fill screening gaps that still persist in modern sleep medicine.

Embla officials contend that sleep is a unique field in the medical industry, because the most extensive test (the PSG) is run first, often without the benefit of screening or preliminary investigation. Every other medical procedure includes some form of triaging the patient starting from a simpler, inexpensive test followed by more extensive and often more expensive tests if necessary.

The protocol for having an in-lab sleep test is so intimidating that an estimated 25% to 30% of individuals who are referred to sleep labs hesitate to get the help they need. The presence of what Baker calls a first-line diagnostic tool can change that, and he believes the FDA-approved SleepImage system fits the bill. “If even half of the 25% to 30% population not wanting a PSG change their minds once they see the actual results of their test, the health and well being of patients would benefit significantly,” contends Baker.

Motivating Patients to Act

Embla officials believe sleep disorders are significantly under-diagnosed because there are no simple home sleep tests to objectively measure sleep quality that would be equivalent to a thermometer or blood pressure cuff. The thought of spending a night in a sleep clinic is threatening to many patients, and without tangible evidence of the disorder, many patients tend to ignore it.

“Home sleep testing is divided between subjective questionnaires and simple screeners which can indicate whether, for example, an apneic event may have occurred, but that won’t tell you if or how it impacted your sleep,” says Baker. “The real question is: Are you are having good quality sleep or not? We believe we have the only product in the market that offers the answer to this obvious, but overlooked question.”

A big concern about having non-objective testing is that you will often get the wrong answer. “If you ask a commercial driver how he sleeps, he will probably say he sleeps well, because he knows that if he is identified as having sleep apnea, his license could be in jeopardy,” says Baker. “People will answer questionnaires the way they want, and not necessarily the way they should. With SleepImage, you can actually test people and validate how they are actually sleeping.”

Sleep Quality is Key

Developed by physicians at the Beth Israel Deaconess Medical Center, an affiliate of Harvard Medical School, Cardio Pulmonary Coupling (CPC) technology, in conjunction with the SleepImage M1™ recorder, is able to measure actual sleep quality. According to Baker, CPC is the world’s first clinically validated technology to simply phenotype obstructive sleep apnea, and the more difficult to identify complex sleep apnea, which he says can now be spotted through a home sleep test thanks to SleepImage.

The SleepImage system consists of a small credit card sized sleep screener called the M1™, and a secure web-based software program that allows patient data to be uploaded securely from any Windows®-based PC for review by a clinician. The simple and inexpensive test allows physicians and clinicians of any discipline to evaluate sleep quality. This has never been done before and Embla officials believe it will be a paradigm shift in how sleep will be viewed in the future. It will show the impact of the changes in therapy, medication, sleep hygiene or weight gain/loss over time. There is also value in using the SleepImage system as a screener before surgery to identify patients with high risk of sleep disorders.

Uncovering the Truth

Baker points out that certain PSG or therapy device compliance data can indicate “everything looks fine” when that is far from the truth. SleepImage, he says, uncovers a reality that can shock potential patients into action. “CMS requires that the patient’s sleep disorder is ‘improved’ as a result of the therapy, not simply that they wore the device. A simple measurement of compliance does not address whether patients are sleeping well or that they actually have better quality sleep,” explains Baker. “That’s the paradigm shift between the old way of doing it, which is measuring the events, as opposed to asking whether patients are sleeping well, and answering the question in an objective way.”

The SleepImage system will make its debut at SLEEP 2011 in Minneapolis this year, and is currently being introduced to large sleep operations. A trial of the SleepImage system was done at the National Jewish Hospital in Denver to validate the model of using SleepImage within a sleep facility. Findings should be published soon.

Baker believes that much of the business potential for sleep labs to increase their occupancy starts with that 25% to 30% of patients who were identified, but refused for one reason or another, to take the full PSG test. Faced with the SleepImage data, which objectively measures patient sleep quality, the hope is to convince them to seek treatment in the sleep lab.

David Baker, president and CEO of Embla Systems, is based in Denver. He can be reached at david.baker@embla.com. For more information on Embla, visit http://www.embla.com

Natalie Morin
President & CEO, Sleep Strategies, Inc.

A behind the scenes look at how sleep scoring services aim to form seamless partnerships with clients.

The use of sleep scoring services has gained tremendous momentum as more and more hospitals and sleep labs change their internal operations to incorporate this progressive business practice. Over the course of the last decade the process of scoring sleep studies in-house has increasingly moved out of the laboratory and into the hands of specialized scoring service companies. This reflects not just a desire to cut costs, but a recognition of the value that a third party can provide as part of a strategic concentration of sleep laboratory resources.

By now, most hospital administrators and directors are aware that sleep record outsourcing can deliver more than just labour cost savings. By freeing up staff to work on marketing, community outreach and patient initiatives, sleep record outsourcing allows for the generation of new revenues, increases in productivity and the management of risk that would have been previously unaffordable. However, sleep record outsourcing offers more immediate benefits as well. Sleep scoring firms have the ability to provide rapid turnaround and perhaps the highest level of scoring quality available by registered technologists. Where cost cutting often forces labs to stretch their labour power—simultaneously jeopardizing patient care—most sleep scoring services are exclusively devoted to the sole task of ensuring the meticulous analysis of sleep studies. The level of quality available from a third party specialist is near impossible to achieve in a hospital or lab where there exists multiple duties to which need attending.

With so many benefits to be had by outsourcing sleep scoring, one might inquire as to why it isn’t yet standard practice. According to Chad Doucette, V.P. Sales & Marketing of Sleep Strategies Inc., “Many clients have told us that they were hesitant about the process at first—doubtful that an outside firm could easily integrate with pre-established internal procedures. But once they realized how a little initial diligence results in a seamless long-term relationship, their concerns are usually eased.” This article will familiarize readers with the step-by-step process of aligning with a scoring service. Using one of the industry’s leading scoring companies as a guide, it will show you how Sleep Strategies Inc. has managed to remain at the top of the game by not merely acting as a service provider, but as a virtual extension of their clients’ labs.

BEFORE YOU BEGIN

When it comes to the decision of whether or not to bring a sleep scoring service on board, scoring is surprisingly not the primary task on the agenda. The first question a sleep facility manager must ask themselves is WHY—why should we consider outsourcing our sleep studies? Begin by comparing your situation to the following statements made by various Sleep Strategies clients before they came on board:

• “Over the course of the last few months our lab has experienced a number of HR issues. Most importantly, we haven’t been able to find enough registered sleep technologists.”
• “Hospital administration has slashed our operating budget forcing us to scale back over-time hours.”
• “We have such a backlog of sleep studies that our patients sometimes have to wait weeks before receiving results.”
• “We don’t have a devoted quality department.”
• “We’re looking to expand our facility but don’t know if we can afford additional staff.”

The above are just some of the factors that commonly lead hospitals and labs to outsource their scoring. Whatever your reason, remember that once the decision to hire a scoring service has been made, you are hiring a partner for your sleep lab—one who must be trusted with your business practices and patients. Choose wisely.

THE SELECTION PROCESS

Demand for sleep studies has increased so significantly that it’s now surpassing the number of registered sleep technologists available—which means, if you’re not careful in your selection process, you could easily end up with an under-qualified scoring service. Below are five key questions to ask any potential scoring service:

• Do you have RPGSTs (registered polysomnographic technologists)? This is a must for efficiency and accuracy of test scoring, but don’t assume it’s a given. Establish in advance whether an RPGST will be handling the scoring process in its entirety—not just supervising the process.
• What about a Quality Assurance Department? A reputable scoring company will have a designated quality-assurance department. This department should have a program which includes: routine review of all scoring technologists, inter-rater reliability and audit reviews as well as scoring guarantees with a policy for re-scoring.
• Do you perform manual scoring? For the most reliable results, a registered technologist should score sleep studies manually. Automatic software scoring is not as accurate.
• Do you have Liability and Errors & Omissions Insurance? A sleep-scoring company should carry the same level of insurance as your sleep laboratory. This should include general liability as well as errors & omissions insurance.
• Is management separate from scoring? In some organizations, the person scoring your studies is the same person managing the company. Favour scoring services with a devoted management team, separate account reps and an RPGST committed solely to the task of scoring your studies.

Remember, qualified institutions will welcome such questions. Aligning yourself with a reputable service will not only enhance productivity and efficiency, but let’s not forget: your reputation too.

GETTING STARTED: THE INTEGRATION PHASE

Once you’ve decided on your ideal scoring service provider, the question that now remains is: how to get started? While the beginning phases of integrating with an external provider should be treated meticulously, the process need not be painful. “At Sleep Strategies we see ourselves as an extension of a sleep laboratory,” says Natalie Morin, president & CEO, Sleep Strategies Inc., who adds,” when clients are done asking us questions, we make time to ask a few of our own.” What Morin means by this is that for Sleep Strategies, the pre-scoring integration phase begins with the completion of a scoring questionnaire. This allows a lab to convey their expectations to the service provider, who in turn is equipped with the requisite understanding of pre-existing scoring criteria.

While a reputable scoring company will always score studies to meet AASM standards, individual sleep labs will typically have their own nuances or additional scoring criteria that they wish to have upheld. “The scoring questionnaire is the foundation for providing the successful delivery of sleep scoring,” says Doucette, who believes that one-size-fits-all solutions have no place in the world of scoring. “Good doctors and technologists have put years of experience and training into refining their scoring processes,” he adds, “It’s important that we tailor our approach to reinforce, not negate, the nuanced and varied habits of each of our clients.”

Once the scoring questionnaire is completed it is then subject to a detailed review by Sleep Strategies’ Quality Assurance department. Questions and clarifications are often necessary at this phase to ensure the team of registered technologists assigned to a given account fully understands their client’s scoring perimeters, which extend beyond industry standards. “No two sleep labs are the same and no two medical directors are the same. This questionnaire process allows us to adhere to strict standards while still honouring how one lab differs from another in its scoring technique,” Doucette emphasizes.

DATA TRANSFER PHASE

Delivering patient information over the Internet can be a simple, convenient and cost effective method for data transfer, as long as the method is secure. Provided that the scoring service provider uses a reputable transfer system, electronic methods of information exchange can allow for the delivery of sleep study results in record turnaround times.

“Ensuring that your sleep scoring service has a HIPAA compliant data transfer system is key”, says Morin, who explains that most such well-developed transfer systems are not only reliable, but also easy to install and operate. “Our transfer system is considered one of the most user-friendly systems that exists. Our clients regularly remark on its ease of use and simplicity,” says Doucette. However, what is perhaps even more important than ease of use is having a technical support team on hand to assist clients and ensure that the transfer system runs effectively and securely. “24-hour turnaround times is a lofty goal. We wouldn’t make this promise to our clients if we didn’t have faith in the useability and reliability of our software,” Doucette goes on to say.

THE CALIBRATION PHASE

The scoring questionnaire has been filled out and the transfer system has been installed to allow for the relay of patient sleep studies. The next step—once again—involves the Quality Assurance department. This time, they’re looking to review clients’ pre-scored, in-house sleep studies. Providing a scoring service with several internally scored “gold standard” studies allows a sleep scoring service provider to compare and cross reference real-life scores with the preferences outlined in the questionnaire results.

In doing so, ambiguities can be identified and resolved before the third-party scoring begins. In this sense, a good scoring service also serves as an external consultant who can identify inconsistencies and make recommendations for improvement. This process simultaneously gives the scoring service an example of a lab or hospital’s unique scoring protocols and procedures. For example, Hypopnea definitions can vary from facility to facility. Many doctors also want to see additional events scored, such as EKG arrhythmias, as opposed to just commenting on them—a good scoring service will have mechanisms to observe these client preferences.

THE SIGN-OFF PHASE

Once the scoring questionnaire and “gold standard” studies have been reviewed and all questions answered, Sleep Strategies asks for several patient sleep studies to be sent for the test scoring phase. This allows the client to assess the sleep scoring company’s approach before signing off on quality and allowing the scoring process to begin.

As is the case with most business partnerships, a service agreement will need to be signed to ensure such issues as patient confidentiality and adherence to process are fulfilled. Any sleep service that does not require clients to sign an agreement should be viewed with suspicion. Service agreements outline turnaround times, pricing structure, cancellation terms and confidentially requirements. For many hospitals the vendor will also need to provide proof of insurance at this phase, as well as a signed business associate’s agreement.

With the paper work out of the way, it’s now time to start the scoring process.

A BEHIND THE SCENES LOOK

A sleep scoring service is a busy operation. Organizations such as Sleep Strategies score studies for hospitals and sleep labs across the country. “On any given month, Sleep Strategies is scoring thousands of sleep studies. Each sleep lab has their own scoring nuances, turnaround times and expectations. We have some clients that are expanding, others that are going through accreditation and some that are dealing with unexpected growing pains—adapting to the various rhythms of each clients’ operations is a necessary part of our success. Flexibility and timing is everything in this business,” says Morin.

Scoring services are typically made up of various departments, such as a general polysomnography division, a specialized pediatric division and a research division, for example. In order to coordinate the multiple interests competing for attention, a scheduling department may also be necessary. This attention to detail is key so that all contracted scoring deadlines are met. ”Our scheduling department along with our specifically developed and proprietary scheduling software ensures our clients’ sleep studies are scored on-time, every time,” explains Morin.

Constructing a successful scoring service is more than just a matter of employing the best RPSGTs to conduct scoring; it requires a team of professionals from account executives, administrators, clinical directors, quality assurance managers to uphold the level of scoring this sector of sleep medicine has built its reputation on. “The true success of Sleep Strategies lies in the foundational belief that a scoring service is more than just a vendor for a sleep lab. We see ourselves as an extension of each and every one of our sleep labs and hospital partners,” says Morin, who hopes that such partners will continue to recognize the cost savings and efficiencies that come with bringing on a sleep scoring service.

Natalie Morin, President & CEO, Sleep Strategies Inc. proves that incorporating a scoring service as part of an operational business strategy can assist sleep labs and hospitals significantly cut costs and increase productivity.