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CLP08_p16-17_bestof_COVER_QA.indd 17 8/3/12 3:55:42 PM

18 Clinical Lab Products | Best of 2012

Table of Contents

20 Vista Clinical Diagnostics Exceeding Expectations By Jim HutH

24 Biocare Medical Patient-Centric Focus, Leading-Edge Innovation By CHris GaeriG

25 Health Network Laboratories Making Great Strides: The Mission By steven Bernstein

26 Medical Neurogenetics Medical Neurogenetics: Leading the Way By JoHn sHoffner, mD, anD KeitH HylanD, PhD

27 Morristown Medical Center LEAN Machine By Jl silverman

28 RPL Laboratory Solutions Inc Making Reality from Theory By renee Diiulio

CLP’s BesT of 2012 Program Panel

The editors of Clinical Lab Products extend their appreciation to the following industry professionals who assisted in the review process.

Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), founder, president, and CEORPL Laboratory Solutions IncCorona, Calif

Ronald A. Blum, PhDCOO (interim)Senior vice president, marketing and strategic business developmentPathology IncTorrance, Calif

Patricia Mullenix, BS, MT(ASCP)SHHematology/Satellite Labs technical managerMemorial Health University Medical CenterSavannah, Ga

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Best of 2012 | Clinical Lab Products 19

a supplement to Clinical Lab Products

Our annual profile of some of the industry’s top clinical lab professionals.

www.clpmag.com

Best of 2012 | clinical laBs

Arizona Community Physicians LaboratoryTucson, AZ520-547-3919www.azacp.com

Arkansas Valley Regional Medical Center LaboratoryLa Junta, CO719-383-6133www.avrmc.org

BioCARe MediCALConcord, CA925-603-8038www.biocare.net

Blanchard Valley HospitalFindlay, OH419-423-5318http://thecore.bvhealthsystem.org

Boone County Health CenterAlbion, NE402-395-3140www.boonecohealth.org

Breckinridge Health inc LaboratoryHardinsburg, KY270-756-6542www.breckhealth.org

Cardiovascular Medical Group of Southern CABeverly Hills, CA310-278-3400www.cvmg.com

Comprehensive Cancer Centers of NevadaLas Vegas, NV702-952-3400www.cccnevada.com

Fairbanks Memorial HospitalFairbanks, AK907-458-5624www.bannerhealth.com/Locations/Alaska/_Alaska+Locations.htm

Firelands Regional Medical Center Clinical LaboratorySandusky, OH419-557-7487www.firelands.com

Florida Hospital LaboratoryOrlando, FL407-303-1925www.flhosp.org

Genova diagnosticsAsheville, NC828-253-0621www.GDX.net

HeALtH NetwoRk LABoRAtoRieSAllentown, PA610-402-8170www.healthnetworklabs.com

Helen Hayes Hospital Clinical LaboratoryWest Haverstraw, NY845-786-4000www.helenhayes hospital.org

ingalls Memorial HospitalHarvey, IL708-915-5771www.ingalls.org

internal Medicine AssociatesLas Vegas, NV702-369-1344www.imalv.com

intracellular diagnostics incMedford, OR541-245-3212www.exatest.com

Jacobi Medical CenterBronx, NY718-918-5129www.nyc.gov/html/hhc/jacobi/html/home/home.shtml

John t. Mather Memorial HospitalPort Jefferson, NY631-473-1320www.matherhospital.org/

Laboratory Services, Sarasota Memorial Health Care SystemSarasota, FL941-917-1150www.smhcs.org

Lakeland Regional Medical CenterLakeland, FL863-687-1436www.lrmc.com

Magnolia Regional Medical CenterMagnolia, AR870-235-3477www.magnoliarmc.org

Maria Parham Medical Center Henderson, NC252-436-1130www.mariaparham.com

Mayo Clinic Health System - Red Cedar MenomonieMenomonie, WI715-233-7674www.mayoclinichealthsystem.org/locations/monemonie

Medical Center of NewarkNewark, OH740-788-7057www.mcnohio.com

MediCAL NeuRoGeNetiCS Atlanta, GA678-225-0222www.mnglab.com

Mercy Medical CenterSioux City, IA712-233-5246www.mercyhealth.com

Mercy St. Charles Hospital LaboratoryOregon, OH419-696-7291www.mercyweb.org

Methodist willowbrook Hospital LaboratoryHouston, TX281-737-1219www.methodisthealth.com/mwh.cfm?id=36920

Metro Health Hospital LaboratoryWyoming, MI616-252-7152http://metrohealth.net

Mississippi Baptist Medical CenterJackson, MS601-968-3070www.MBHS.org

Molecular Pathology department-Beaumont Hospital Royal oak Royal Oak, MI248-551-7261www.beaumonthospitals.com

MoRRiStowN MediCAL CeNteRMorristown, NJ973-971-5610www.atlantichealth.org/ morristown

Nationwide Laboratory ServicesFt Lauderdale, FL954-633-3580www.esrdlab.com

Northoaks Health SystemHammond, LA985-230-1269www.northoaks.org

NorthShore university HealthSystem LaboratoriesEvanston, IL847-570-2731www.northshore.org

overton Brooks VA Medical CenterShreveport, LA318-990-5392www.overtonbrooksVAmedical center.gov

Paul oliver Memorial Hospital LaboratoryFrankfort, MI231-352-2204www.munsonhealthcare.org/?id=308&sid=5

PhysicianCare LabTowanda, PA570-265-0110www.physiciancarepc.com

PhysicianCare LaboratoryTowanda, PA570-265-0110www.physiciancarepc.com

Portneuf Medical CenterPocatello, ID208-239-1671www.portmed.org

Quest diagnosticsTucker, GA866-709-0772www.QuestDiagnostics.com

Rehoboth Mckinley Christian HospitalGallup, NM505-863-7020www.rmchcs.org

Reid Hospital & Health Care Services Clinical LaboratoryRichmond, IN765-983-3134www.reidhospital.org

Riverview Regional Medical CenterGadsden, AL256-543-5782www.riverviewregional.com

RPL LABoRAtoRY SoLutioNS iNCCorona, CA888-566-5505www.rplLaboratorySolutions.com

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Salem township HospitalSalem, IL618-548-3194www.sthcares.org

Skyline Hospital LabWhite Salmon, WA509-637-2960www.skylinehospital.org

Springs Memorial HospitalLancaster, SC803-286-1214www.springsmemorial.com

Swedish Medical Center Englewood, CO303-788-3145www.swedishhospital.com

tampa General HospitalTampa, FL813-844-7143www.tgh.org

the Med (Regional Medical Center at Memphis)Memphis, TN901-545-7474www.the-med.org

university of Michigan Hospital-department of PathologyAnn Arbor, MI734-615-8863www.pathology.med.umich.edu

upper Connecticut Valley Hospital LaboratoryColebrook, NH603-388-4248www.ucvh.org

ViStA CLiNiCAL diAGNoStiCSClermont, FL352-536-9270www.vista-clinical.com

waianae Coast Comprehensive Health CenterWaianae, HI808-697-3648www.wcchc.com

willis knighton Health System LaboratoryShreveport, LA318-212-4615www.wkhs.com/lab

winchester HospitalWinchester, MA781-756-7658www.winchesterhospital.org

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What if your favorite fine restaurant were to start offering even better menu choices—while lowering their prices, and reducing your wait time? You’d probably start going there more often, while telling your friends about it. What if you were in the restaurant business as well? You’d definitely want to know how they were able to do all that! Well, this is how they did it… except we’re not really talking about a restaurant.

We’re talking about an independent lab that has grown at an average rate of 60% per year for 9 years. A lab that just recently began partnering with other labs—sharing their formula for success—and is now helping those labs grow as well.

Vista Clinical Diagnostics offers the industry’s most advanced testing (including molecular pathology), with prices at Medicare levels, in 44 spa-like centers, with 98.6% of their test menu results delivered the same day.

When Vista began offering same-day results in 2004, physician after physician would say, “You can’t give me results that fast. It’s impossible.” To which, Vista simply said they would, and they did. Then, as if that wasn’t enough, Vista began charging self-pay patients at the same low rates as Medicare reimbursement. And, for those who thought Vista’s low rates were just a market-penetration tactic for the short term, that pricing structure has remained in place for the long term.

Yet, none of these accomplishments would have been possible had Vista not been founded on the principle of always putting the patient first.

How It All BegAnIn 2000, Davian Santana (Vista founder and president) was

working for Beckman Coulter, installing and validating medical equipment in Florida. In doing his job, Santana got to see the

BY JIM HuTH

Exceeding Expectations

Vista Clinical Diagnostics

Vista Clinical Diagnostics offers the industry’s most advanced testing, and recently introduced a partnership program for smaller and medium-size labs.

internal operations of many laboratory facilities across the state. That’s when he began to notice an ongoing lack of personalized care, compounded by high prices and long wait times (for the patient’s on-site time, and for their results to be delivered).

“The patient was not being put first. Likewise, neither were the physicians or the facilities who depended on those labs to deliver timely and accurate results,” Santana says. “Everywhere I looked, it was another upside-down paradigm—another case of ‘the tail wagging the dog.’ ”

Santana had seen firsthand that, although many clinical laboratories talked about patient-focused care, most labs did not deliver with the hard work and dedication it took to create such an experience. Envisioning an opportunity in the existing market—for a focus truly based on service, value and timely accuracy—Santana shared his thoughts with longtime friend, Nathan Hawkins (Vista cofounder and vice president).

Hawkins and Santana met in 1996 while working as medical technologists at a hospital in Alabama. At the time, Santana had recently received an honorable discharge from the Navy, and Hawkins was still on active duty in the Air Force.

Then, after about 3 years in Alabama, Hawkins went to Ortho Clinical Diagnostics in Pennsylvania, while Santana made his move to Florida—where he soon saw the need for an organization like Vista, and contacted Hawkins.

“For 3 hours on the phone, we bounced ideas off each other—ideas that would become Vista,” Hawkins says. “Even though I’d just received a promotion and built a new home in Pennsylvania, by the end of that phone call I was already planning my move to Florida.”

Leveraging their homes, assets, and time, while often working a combined total of 200 hours a week between their day jobs and building their lab at night, Santana and Hawkins

Davian Santana, president, and Nathan Hawkins, vice president.

realized their vision when Vista Clinical Diagnostics was incorporated in July 2003.

CHoosIng Better servICeHaving been built upon the ethics of higher-quality health

care at affordable prices with excellent service, Vista has been consistently rewarded—allowing Santana and Hawkins’ first little laboratory in Minneola to progressively expand across 13 Florida counties.

Offering some Zen-like insight into their tremendous growth, Santana simply says, “What’s good for our patient is what works for us.” In other words, Vista has grown by choosing to provide better service.

Patients at each of Vista’s 44 locations are treated in a spa-like atmosphere that is relaxing, attentive, and never lengthy—only 10 or 15 minutes at most from the time they walk in the door. Clients, such as the more than 200 nursing homes and assisted living facilities that rely on Vista for everything from friendly and helpful couriers, to the different ways they need to receive their reports, are never disappointed.

“Whenever a patient or client wants better service, they choose Vista,” says Pat Owen, Vista office manager. “Our success story is told in the lives we’ve touched, and the beliefs that have changed in our patients who now think: not only is Vista the better choice, it’s that Vista is really trying to make a difference with their quality of care. Then, once they’ve experienced Vista, they keep coming back. Our retention rate is extremely high, and we earn that honor every day.”

In the very beginning, Vista recognized how lab work had become a commodity. “We took something that was a commodity,” Owen says, “and brought back humanity to it. This comes from the top and trickles all the way down. For example,

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Microbiology Department

one of our elderly patients, with the onset of dementia, was having a hard time. The daughter called to ask if anyone could be sent to the home as her mother was having difficulty getting up. Our phlebotomist did not hesitate in going to the home and obtaining the sample. People caring for people, that’s what it’s all about.”

“Our patients and clients also help determine where we go, and what we change,” Hawkins adds. “At Vista, we affect one patient at a time, and when we’re successful with that one patient… mission accomplished. When we do that for 6,000 to 7,000 patients a day… mission accomplished. And we do it all with a percentage of error that’s practically nonexistent—less than .01%. However, within that .01%, what matters most is how we correct it—what we do next, how we grow and change.” (As this article was going to press in July, Vista received an amazing 100% on its accreditation inspection - for the second time!)

“How MigHt we …?”“We’ve spent a lot of time and resources on reinvesting

in ourselves—to stay ahead electronically, technologically, and with our workforce because,” Hawkins says, “if people were to get frustrated and overworked, things could start to break down.”

“I think what’s really crucial at this point for Vista is that we reintroduce our people to—and really focus on—the program that started Vista 9 years ago,” he says. “It’s a strong and

proven program, and it’s based on experiences. When you come to Vista, what are you experiencing? And, what do you want other people to experience with you? It’s about understanding that each person in our organization believes in something better, and that each person in our organization has the power to make a difference.

“Which is why we make each and every one of our 250 employees part of the plan,” he says. “Their voice is of great concern to me. If you’re going to be in our culture, you have to be the culture—you have to contribute. The best thing about what Davian and I do is we help them create, we help them invent, we make them part of the plan. They contribute foresight, leadership, ideas, intellectual property. I think companies struggle, falter, and fail without these contributions. That’s why it’s important to always be asking, ‘How might we…?’ ”

Obviously, Vista has never been content to be just another clinical testing facility. This drive to always do things better has enabled Vista to truly change their industry. And, along the way, Vista has guaranteed that no matter how big or small their company is, there are certain fundamentals that will never change in their business model. These fundamentals are the cornerstone of the Vista mission statement. Based on that mission statement, Vista guarantees these 10 things to every patient, physician, and client.

• Noappointmentnecessary—ever.

• Averagevisittimesof15minutesorless.

• Medicareratesfortheuninsured.Neverapennymore.

• Real“live”customerservice.Apersonwillanswereverycall made to Vista.

• Around-the-clockaccess.Whenitcomestohealththereisno “time off.”

• Same-dayresults.IfitcanbetestedinaVistalab,you’llhave results before the day is over.

• Quality of supplies. Therearemanyefficientwaysofcuttingcosts.Materialsshouldneverbeoneof them.That iswhy Vista uses only the finest equipment, including needles, test tubes, and transportation techniques to ensure accuracy and comfort for the patient.

• Qualityofequipment.Only the latest in technology toensure the highest accuracy of results.

• Spa-likefacilities.Clean,comfortable,andinviting.

• Smiling,professional,andcourteous staff.Vistapridesitself on customer care that starts from the moment you walk into any Vista location.



Vista Partner ProgramAfter nearly a decade of 60%-per-year growth, what’s next

for Vista? Partnering with other labs that share Vista’s vision for putting the patient first.

“What if the smaller and medium-size labs were no longer available, and you no longer had a choice?” Santana asks. “A very real and vital concern for the future is: in a market totally dominated by the national labs, there would be no incentive for the national labs to improve their customer service—they’d already have the contracts, so they’d know the patients would have to come to them.”

“I find it frightening to consider a scenario where 70% of all medical decisions being made by physicians are determined by only one or two national labs,” Santana says. “It’s yet another reason why other parties should not be making decisions about your personal health. Not to mention what happens should all the small and medium-size labs go away, and all of their patients had to start crowding into the national labs, making them even more crowded than they are now.”

To help thwart those possibilities, Vista recently introduced a partnership program for smaller and medium-size labs. “We’re facing very difficult times with the cost of supplies, equipment, EMR, bidirectional interface, the cost of interfacing directly to a physician’s EMR, and more,” Santana says. “Partnering will reduce those costs, while increasing efficiencies.”

Basically, the partner program uses Vista’s buying power, individual property, resources management, and sales expertise to create better business models for smaller labs. The program can also be used by labs for software that creates a new customer base—enabling them to more cost-effectively interface with physicians. “Because some of these labs don’t have a half-million-dollar software system, they can’t even start interfacing with physicians. Or, when they do integrate the system, it can cost an additional $14,000 per physician. However, for our partners, Vista can do it for a fraction of that cost. Those are just a few of the benefits we offer other labs,” Santana says.

Recently, the partner program helped a smaller lab save several thousands of dollars per year. That lab was paying more than $20 for a particular test, and had been unable to negotiate a better rate. With Vista, that lab is now paying less than $7 for the same test.

a Partner’s success storyThe genesis of what became Vista’s partner program began

when Earl and Stephanie Adams were considering the purchase of a lab in New Port Richey, Fla. “We knew Davian and Nathan, and so we visited them at their Clermont facility to ask their advice. I knew they owned Vista, but had no idea they’d taken

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In the very beginning, Vista recognized how lab work had become a commodity. “We took something that was a commodity,” says Pat Owen, Vista office manager, “and brought back humanity to it.”



BEST2012

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Vista Clinical DiagnosticsClermont, Flavista-clinical.com

it to the level they had,” Earl Adams says.“They helped us get started, and to avoid the dangers and

pitfalls that come with this kind of growth. Thanks to their insight and knowledge, we’ve grown our business at a rate that would not have been possible otherwise. And, it has been a great relationship—we totally enjoy working with them. They’re focused on quality and patient care, and so are we. We’re very like-minded in that we treat our patients as individuals—instead of numbers, like the larger labs. Vista has the same philosophy as we do, and that’s important to us,” Adams says.

“Also, we do our ordering straight through Vista now. It’s much easier, and we get better pricing—with their quantity pricing—on everything now. With Vista’s buying power, Davian was able to negotiate exceptional terms for us on our new instrumentation—terms we were not getting on our own. Our annual cost savings alone has made it worth partnering up with Vista,” Adams says. “Now, thanks to our partnership, the rates we charge are typically 60% to 70% less than our competitors.”

Meanwhile, Back in the laBAt the heart of all that Vista stands for, everything ultimately

comes down to the lab and the people who work there. Vista’s cutting-edge, 35,000-square-foot facility in Clermont is the epitome of what a diagnostic lab should be. This is definitely not your typical “back room” operation. Rather, what Vista has created is akin to a “Silicon-Valley flagship” of the best

equipment, in the best surroundings, staffed by the best people.Of course, there’s all the latest technology from leading

suppliers, such as Abbott. And, just to be sure there is never any downtime, there are backups and built-in redundancies throughout the different labs.

The lab is spacious, well-organized, and very clean. The layout of the equipment and workstations was designed with the help of Vista lab personnel, and provides for a seamless flow of work.

To ensure the quality and reliability of their test results, 98.6% of Vista’s tests are done on-site in the Clermont facility; which also serves as a reference laboratory, offering more than 1,000 tests, ranging from routine screenings to highly esoteric molecular and genetic assays.

Also, Vista has its clinical pathology and anatomical pathology under one roof, instead of separate locations as with most other facilities. Thanks in part to this arrangement, Vista pathology testing results seamlessly integrate with clinical reports digitally.

However, what really makes Vista’s labs exceptional are its people and their dedication.

neeta Mauskar Ms, Mt(ascP)Neeta Mauskar, Vista’s microbiology/molecular biology/

serology manager, knows that when she sees a sample, she is seeing so much more—she is seeing the person behind the sample as well.

“Each and every patient is important to us. What if they were

someone from my family? If someone close to me were sick, I’d want them to receive the best care possible, so that’s the type of care I provide every patient,” she says. “Just knowing that one day that sample is going to represent me, and the people I love, makes me feel very responsible for what I do. And, this is how Davian and Nathan feel as well. It’s this type of thinking that brought me to Vista 8 years ago, and it’s what keeps me dedicated to what I do.”

kathy JonesAs Vista’s laboratory manager, Kathy Jones is always striving

for the best of the best. She says, “I’m the one who goes around and makes sure everything is done the right way. The right way according to the state, the instrument manufacturers, and the employees.” Nothing gets past her.

She makes sure everything is tested correctly and that all of the results Vista releases are valid, correct results. “If it comes to where we have a specimen that appears compromised, that specimen will not be run,” she says. “I have the highest integrity, and that’s what our patients deserve. In the end, the patient is going to win—and that’s why, when I go home at night, I feel good about what I did that day.”

Her following comments are a perfect representation of what you’ll hear throughout Vista. “I love my job. I have a lot of responsibility, but I love the people I work with, and I have a lot of freedom. If I want to launch a new test and have done the appropriate research, I will have full administrative support. That’s what makes Vista better—we’re always growing, always changing, always doing something new to improve our patient services. Our patients will always be our first priority.”

in closingThe quantity will NEVER supersede the quality Vista delivers

each and every day… “One Patient at a Time.”

Jim Huth is a professional writer and interviewer.

Pathology Department

Vista began charging self-pay patients at the same low rates as Medicare reimbursement. And, for those who thought Vista’s low rates were just a market-penetration tactic for the short term, that pricing structure has remained in place for the long term, says Davian Santana, founder and president.



The mission of Biocare Medical, Concord, Calif, is to serve its clients’ diagnostic needs, but perhaps more importantly; the company realizes that the real beneficiaries of its products are the patients. The company specializes in developing simultaneous Multiplex IHC tests for its customer base of clinical histology laboratories, pharmaceutical companies, CROs, and biotechnology companies as well as academic, government, military, and other nonprofit laboratories. However, the goal of providing improved patient care is never out of focus, and that is something that is not lost on Joe Vargas, director, Research and Development, Biocare Medical.

“Ultimately, it’s the patient that we’re looking at indirectly,” Vargas says. “We really focus on developing our products for their needs. Laboratories need to have the highest specificity possible to have the correct diagnosis for the patient. The goal is to make sure we do everything on our part to develop the highest-quality products so that pathologists can make the best diagnosis.

“Our quality is never an accident,” Vargas says. “It is a result of continuous improvement and dedicated efforts on our part. We are customer-based, and that’s what we strive for: to satisfy our customers’ needs and to continuously improve.”

Beginning as an electron microscopist, Vargas has held a variety of different positions throughout his career to gain full lab knowledge and learn new skills and techniques at each step along the way. Working for institutions such as the University of California, San Francisco (UCSF), and the Letterman Army Institute of Research, Vargas has learned techniques from in situ hybridization to immunohistochemistry, and has earned

By CHRIS GAeRIG

Patient-Centric Focus, Leading-Edge Innovation

Biocare Medical

Biocare Medical develops simultaneous Multiplex IHC tests for its customer base of clinical histology laboratories, biotechnology companies, nonprofit labs, and others.

his HTL from the American Society for Clinical Pathology. Nevertheless, it was his research with animal tissues at the Letterman Army Institute of Research and UCSF that prepared him for his current role.

“The most recent products that I’ve had the most influence upon are the animal polymer detections: our FARMA line of polymers that are specifically designed to work on a variety of animal tissues,” Vargas says. “That’s part of our PromARK™ line where anyone interested in performing IHC on animal tissues can use mouse, goat, rabbit, or rat antibodies with our detection systems. The background is very low, it is extremely sensitive, and is our most recent development as far as our detections are concerned. With my considerable background in animal work, I was primarily responsible for overseeing development [along with David Tacha, HTL (ASCP), PhD, vice president of R&D, chief scientific officer]. There were always these inherent issues with cross-reactivity associated with using a general detection on animal tissues. We really worked considerably long hours in order to develop these products.”

Though Vargas takes pride in all of the work he performs, his proudest achievement at Biocare was his participation in the company’s molecular RISH™ product line, a simple in situ hybridization technology using proprietary DNA probes for rapid visualization of mRNA target expression.

“I’ve been involved with quite a few things here,” Vargas says. “I would say my proudest achievement at Biocare would be the contributions and assistance with the RISH, our molecular product line. This product line is relatively new to Biocare. I spent about 2 to 3 years working on this project, and I would say that’s

Joe Vargas, director, Research and Development

probably my number one thing that comes to mind.”Never one to forget the company’s mission, however, Vargas

has also taken an active role in participating in technical support. He assists primarily with the molecular product lines to ensure the best results for clients. It is this dedication from both Vargas and the rest of Biocare that has afforded the company its continued success and awards.

“There are so many things that we’ve achieved here,” Vargas says. “We have a great team. Our Technical Support, our education Center, and our R&D staff are very knowledgeable, and I don’t think there’s another competitor out there that has our capacity to support and respond to the client in the way we do. We have a good group of excellent specialists here. Without them, it would be a very difficult thing to move forward and continue to improve.”

Chris Gaerig is associate editor for CLP.

Biocare MedicalConcord, Califwww.biocare.net

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Health Network Laboratories (HNL), Allentown, Pa, is a multiregional medical laboratory with technologically advanced facilities in Pennsylvania and New Jersey.

The company offers a full complement of clinical pathology, anatomic pathology, and forensic pathology services, including highly specialized esoteric testing to hospitals, physicians, long-term and assisted living facilities, businesses, and government agencies.

Highly rated by physicians in all areas of laboratory performance and highly rated by patients in all aspects of customer service, HNL aims to be a leader in diagnostic lab medicine by providing the highest-quality and most responsive and cost-effective service to its customers.

New LeadershipLeading HNL’s success is Peter Fisher, MD, MBA, the new

president and CEO, who replaces recently retired CEO David G. Beckwith, PhD. Fisher had previously been chairman of pathology and laboratory medicine at HNL. Prior to joining HNL, he served on the faculty at Columbia University Medical Center, New York, and as chairman of pathology, Palisades Medical Center, North Bergen, NJ.

respoNsive service to cLieNts aNd patieNts

As part of HNL’s commitment to excellence and its goal to become a leader in lab medicine by providing superior patient access, HNL has continued to expand its patient access points by opening four new patient service centers in the past 6 months; three in Pennsylvania, and most recently, one in Phillipsburg, NJ. Now with more than 45 conveniently located centers, patient access to expert phlebotomy service has never

BY STEvEN BErNSTEiN

Making Great Strides: The Mission

Health Network Laboratories

Health Network Laboratories is a recognized leader in clinical laboratory and anatomic pathology testing.

been more convenient. All centers provide interpretation services for patients with more than 150 languages available.

commitmeNt to highest-QuaLity Lab mediciNe

HNL, a full-service medical laboratory accredited and federally licensed under the Clinical Laboratory improvement Act, is approved by Medicare and Medicaid and accredited by the College of American Pathologists. Through its core and rapid response labs, HNL serves the public and health care communities with more than 60 million reportable clinical and pathology test results each year, performing 99% of all test orders in-house.

HNL’s Center for Anatomic Pathology provides a full range of subspecialty consulting and diagnostic services using state-of-the-art technology, thereby providing the best service available to its clients and their patients, including gynecological and nongynecological cytology, surgical pathology, molecular pathology, flow cytometry, toxicology, and forensic pathology.

board-certified physiciaNs aNd scieNtists

A staff of more than 25 board-certified and subspecialty fellowship-trained pathologists and PhD-level scientists work closely with HNL’s laboratory technical staff to provide the best expert consultation on the diagnosis and treatment of disease.

The Center’s experts also provide diagnostic services in immunohistochemistry, in-situ hybridization, immunofluorescence, electron microscopy, and flow cytometry. HNL pathologists also provide consultative services to other physicians regarding diagnostic tests, results, and treatment, and an unprecedented 24/7 access to its

pathologists through its customer service hotline.

affiLiatioNsAs part of its goal to be a leader in state-of-the-art lab

medicine, HNL is a designated roche Molecular Center of Excellence (MCOE). HNL is also licensed by Hunter Laboratories of Campbell, Calif, to perform the proprietary Hunter Heart Panel for cardiac risk assessment.

cuttiNg edge LeadiNg the wayHNL offers the highest-quality leading-edge lab testing,

including highly specialized esoteric testing to hospitals, physicians, long-term and assisted living facilities, businesses, and government agencies.

its breadth of sophistication and strategic effort enables HNL to be the regional leader in lab medicine and to be consistently highly rated in customer satisfaction by its clients and patients.

Steven Bernstein is a contributing writer for CLP.

Health Network LaboratoriesAllentown, Pawww.healthnetworklabs.com

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When you enter the state-of-the-art diagnostic and research facility of Medical Neurogenetics (MNG) in Atlanta, you immediately recognize the hallmarks of a successful company. The building is airy, modern, and bright, and provides an environment conducive to active discussion, interaction, and productivity.

MNG was formed by John Shoffner, MD, and Keith Hyland, PhD, in 2008 and has been rapidly expanding ever since. Prior to forming MNG, both had prestigious academic careers. John was associate professor of neurology and molecular medicine at Emory University and then directed the molecular diagnostics program at Children’s Healthcare of Atlanta. He is currently adjunct associate professor in the Department of Biology at Georgia State University. Keith was lecturer in biochemistry, University of London, UK. In 1989, he joined the Baylor University Medical Center in Dallas. He was professor in biomedical sciences at Baylor University and adjunct associate professor of neurology, University of Texas Southwestern Medical Center.

John is a leading expert in the area of mitochondrial disease, and Keith in the field of neurotransmitter disorders. The pair have more than 200 scientific publications and have presented at more than 100 national and international scientific symposiums.

”Many inherited neurological conditions require CSF analysis to allow diagnosis,” Hyland says. “These include movement disorders caused by defective neurotransmitter metabolism, seizure disorders that respond to pyridoxine or pyridoxal phosphate, and cerebral folate deficiency. The latter is being recognized as a major cause of neurological dysfunction.” Keith is very proud to have been involved in the initial discovery of many of these conditions, to have developed several of the tests used for diagnosis, and to have seen MNG become one of the foremost centers in the United States that specializes in CSF testing.

“The study of neurometabolic and mitochondrial disease has always been at the forefront of my clinical and research career,”

By JoHN SHoFFNEr, MD, AND KEITH HyLAND, PhD

Medical Neurogenetics: Leading the Way

Medical Neurogenetics

The company provides a complete spectrum of clinical care for patients with neurometabolic and other inherited disorders.

Shoffner says. “I discovered some of the first epilepsy mutations and some of the first gene mutations that cause mitochondrial disease. Correct mitochondrial function is vital for core cellular processes, including the production of energy that allows cells to grow and work properly. We are now moving to a point where we have sufficient knowledge to begin treating these disorders.”

MNG has become a leading force within the developing sector of neurogenetics. “The company is unique, by providing a complete spectrum of clinical care for patients with neurometabolic and other inherited disorders,” Shoffner says. “This encompasses the whole process, which includes clinical consultation, advanced metabolic and molecular diagnostic testing, treatment, education, and research.”

The reputation of the company is such that patient and sample referrals have grown rapidly. referrals cover an expansive geographic footprint that includes the United States, Canada, Australia, the Middle East, Europe, and South America.

on the diagnostic front, MNG employs a host of cutting-edge techniques, including advanced biochemistry, enzymology, sequencing using both capillary and next-generation techniques, and live cell analyses. It offers more than 1,100 different tests and is predicting to expand to more than 5,000 in the near future as it moves to provide many more targeted next-generation sequencing panels. New testing approaches are currently being patented.

“The advent of next-generation sequencing has revolutionized our approach to medical genetics,” Shoffner says. “Where a single gene used to be sequenced at a cost of several thousand dollars, we can now examine many thousands of genes for a similar price.”

MNG is developing next-generation sequencing panels targeted to particular neurogenetic sectors. These include seizure disorders, cellular energetics, neurotransmitter disorders, myopathies, muscular dystrophies, hereditary neuropathies, cardiomyopathies, and neurodegenerative conditions. Cost-effective approaches for many other categories of disease are under way.

Keith Hyland, PhD John Shoffner, MD

Medical NeurogeneticsAtlanta www.mnglab.com

The research background of the MNG owners ensures a continuing research focus within MNG. The company owns a proprietary human tissue bank and a relational database of clinical, metabolic, biochemical, and genetic data. “our tissue bank and database has significant test-development and drug-discovery implications,” Shoffner says. “The database can be used to select tissue or cell lines from our bank of over 15,000 samples. This is a highly unique resource containing cell lines, muscle, and CSF from patients with numerous biochemically and genetically defined disorders. We are currently in collaboration to test new drugs using cell lines from patients with clearly defined mitochondrial disease. Drugs having a protective effect on mitochondrial function can be beneficial not only to patients with mitochondrial disease, but also to patients with cardiac disease, Alzheimer’s disease, Parkinson’s disease, stroke, and many other disorders where there is secondary mitochondrial dysfunction.”

“research and development is a vital part of company growth,” Hyland says. “Since starting MNG, we have published over 30 papers, presented at multiple national and international meetings, and have received several federal and privately funded grants. our research on mitochondrial disease and autistic regression was named as one of the Top Ten Autism research Achievements by Autism Speaks. We know we are on the right track!”

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Helping patients at Morristown Medical Center has been a process in creating a structure and culture of process improvement and empowerment for its employees. The biggest changes in the system have been empowering the staff through process improvement. Michael Overa, Atlantic Health laboratory director, who started with Six Sigma in 2001, moved into LEAN because “it enables us to change the culture of the laboratory,” he says.

One of the unique features of Morristown is the implementation of a career-ladder program called PACT: Professional Advancement Clinical Tracks. In this program, a staff technologist signs up to do more than he or she does on a regular basis by taking on similar duties of a coordinator or manager-level employee. LEAN is a major portion of the PACT program. Staff members themselves come up with the process-improvement projects as part of the PACT program. At the end of the program, both the institutions and technologists benefit.

Having LEAN, and marrying it with the PACT program, has increased employee engagement scores considerably over the last couple of years, to where they are now among the highest within the institution of Morristown Medical Center. “We went from a 48% engagement score back in 2003/2004, and now we’re in the ‘90s,” Overa says. “What I try to convey is that not only are people happier to work here—more engaged—but their workload has increased about 33% at Morristown.”

Overa says when he first arrived at Morristown, employees were constantly saying, “We need more people.” More staff members weren’t necessarily added, but the processes in all lab sections were changed, with employee help. In doing that, the engagement scores have now essentially doubled. The LEAN program eliminated waste of extraneous activities such as answering phones or filing papers, freeing up technologists to do what technologists are trained to do.

“What I’m most proud of is that we’ve been able to improve

By JL SILvErMAN

LEAN Machine

Morristown Medical Center

Adoption of LEAN principles at Morristown Medical Center has increased employee buy-in and vastly improved lab operations.

Morristown Medical Center laboratory staff members

personnel,” Overa says. This saves patients a lot of time and worry. The lab no longer has to differentiate between STAT and routine tests. Everything that comes in is acted upon immediately.

LEAN principles have made significant changes for customers, including pharmacy, infection prevention, physicians, and nursing. Multidisciplinary projects driven by the laboratory to improve patient care include nosocomial infection marker reduction, positive patient identification for blood specimens collected in the emergency department, second specimen protocol for the blood bank, nursing duplicate test ordering, and blood inventory and tracking system in the operating department.

This has been culture change for many people. Many come from the experience that a physician spells out what to do. But at Morristown, everybody gets to be part of the process and take pride in that. When you’re part of the process, Morristown’s thinking is you should be part of fixing the process, or making it better … part of improving the process. Morristown Medical Center is constantly looking at what it does, and adapting to changes very quickly.

JL Silverman is a contributing writer for CLP.

Morristown Medical CenterMorristown, NJwww.atlantichealth.org/morristown

“What I’m most proud of is

that we’ve been able to

improve our quality, and one

of the measures of that is

turnaround times,”

says Michael Overa, Atlantic

Health laboratory director.

our quality, and one of the measures of that is turnaround times,” Overa says. “We have greatly improved turnaround times for all testing. The staff is much more engaged in the needs of their customers than they were in the past, and we’ve decreased our cost over time because we’re adding more volume. On a cost-per-unit basis, we’re much lower than we were previously, while offering a much higher-quality product.”

How does this improvement translate to better patient care? We have been able to decrease cost per test by more than 25%. We have been able to absorb approximately 500,000 tests annually while improving Test/FTE by 30%. During this same period, turnaround times have decreased significantly; for example, a STAT CBC with differential would have taken 2 hours in 2003. It is now completed within 18 minutes. A basic metabolic panel is completed within 28 minutes. “We have worked hard to have our medical laboratory scientists perform scientific tasks, and reallocating clerical duties to appropriate

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In theory, any clinical laboratory should be ready for an inspection at any time. In reality, there are many requirements that can vary with each inspecting organization. Laboratory administrators may not be aware of the differences between the regulatory bodies—some may have more stringent requirements than CLIA—or they may not have the tools or resources to properly meet all of the specific needs. The situation can be made more difficult as the regulations tend to be dynamic.

It can take time to determine what is needed for a specific inspection and pull the material together. With unannounced inspections, the time may not be enough. In some cases, small errors can lead to a fail.

“Laboratories don’t have the guidance,” says Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), founder, president, and CEO of RPL Laboratory Solutions Inc, Corona, Calif. They may lack the resources to hire outside help, or they may not have hired the right individual (in-house or contracted) to handle the process.

“Failed inspections are a primary driver for why we are contacted by new clients,” Stewart says. Working as an Expert CLIA Surveyor for CMS (formerly HFCA) and dealing with failed inspections was also what drove Stewart to found RPL in 1986. They are certainly not the only factor driving the growth of the laboratory consulting firm today, but they are a constant issue for the industry.

ComplianCe-FoCusedThe situation has been that way for some time. In the late

1980s, regulations tightened, particularly for physician-office laboratories (POLs). “I was approached by several manufacturer reps who were finding themselves having to consult with doctors, and it wasn’t their expertise. So they asked if I would

By REnEE DIIuLIO

Making Reality from Theory

RPL Laboratory Solutions Inc

RPL Laboratory Solutions Inc, Corona, Calif, helps laboratory clients achieve goals with compliance-focused, business-oriented consultative services.

do it, and I did it, a bit reluctantly. But once I started doing it, I really enjoyed it,” Stewart says.

Her experience as an Expert CLIA Surveyor for CMS gave her further motivation. “I didn’t like just going in and telling laboratories what I saw them doing incorrectly, particularly when I realized they were really struggling trying to comply. But as a Surveyor, you’re not allowed to offer guidance,” Stewart says.

So she completed her tenure and devoted herself full-time to RPL, where she could help labs achieve compliance rather than merely point out their flaws. RPL’s mission is “to provide essential expert professional assistance to the health care community in the specialty arena of laboratory medicine, simplifying the process of maintaining regulatory compliance while maximizing efficiencies, thereby empowering the health care provider with the ability to deliver quality lab testing.”

The operating philosophy is that “every kind of model should be able to offer lab services, if they choose, and control the quality, turnaround time, and availability of testing for their patients,” Stewart says.

Business-orientedThese maxims apply to new laboratories as well, a growing

segment of RPL’s business. “We’re seeing a lot of R&D groups that are developing genetic testing and want to move into the clinical arena,” Stewart says, estimating an average of one to two calls a month from new clients with that goal this year.

The trend repeats a pattern Stewart observed 20 years ago as manufacturers reposition themselves. “I’m seeing almost the same market protocol model emerge,” Stewart notes in regard to the genetic R&D companies.

When helping any client with a new venture, Stewart calls on

Rochelle P. Stewart, MBA, CLS, MLS(ASCP)CM, QLC(ASCP), CLC/MT(AMT), and Matt Stewart, director, IT Systems

her extensive corporate experience (she holds a graduate degree in business administration). “Finances and operations are always going to be a major factor, so we want to incorporate lab into what they’re doing without reinventing the wheel and staying attentive to cost,” Stewart says.

RPL offers a comprehensive program designed for new and existing labs to help meet regulatory requirements. Additional services include maintenance programs for long-term compliance, spot checkups, feasibility analyses, document and correspondence preparation, LIS/EMR project management, safety services, and other consultative expertise. The team is fluid and hired in response to market needs.

Stewart relies on this nationwide group to gather information out in the field on trends, issues, and new models, and to discuss it with an eye toward client needs. “Is it something we can implement across the board that will benefit everybody? Is it a trend laboratories need to prepare for? Is it misinformation we can raise awareness about?” Stewart asks. If the answer is yes, RPL will turn theories into reality.

Renee Diiulio is a contributing writer for CLP.

RPL Laboratory Solutions Inc Corona, Califwww.rplLaboratorySolutions.com

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