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Vaginitis Diagnosis: An Opportunity to Improve Patient Care Editor: Andrea J. Linscott, PhD Ochsner Health System, New Orleans Writer: Lena Chow Palo Alto, CA

DARK Daily Laboratory and Pathology News @ darkdaily.com


Vaginitis Diagnosis: An Opportunity to Improve Patient Care

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Table of Contents Preface by Robert L. Michel

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Chapter 1. Abstract

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Chapter 2. Background

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Chapter 3. The Three Common Underlying Causes of Vaginitis

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Chapter 4. Diagnosis of Vaginitis: Current Practice

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Chapter 5. DNA Probe Technology Opens the Door to Improved Vaginitis Care

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Chapter 6. Implications for Patient Care

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Chapter 7. Implications for the Laboratory

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Chapter 8. Assessing the Opportunity

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Chapter 9. Implementing DNA Probe Technology in the Lab

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Chapter 10. Marketing New Vaginitis Testing Capabilities

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Chapter 11. The BD Affirm VPIII Microbial Identification System at Work

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Chapter 12. Conclusion

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References

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Appendices A-1 About Andrea J. Linscott, PhD A-2 About BD A-3 About DARK Daily A-4 About The Dark Intelligence Group, Inc., and THE DARK REPORT A-5 About the Executive War College on Laboratory and Pathology Management A-6 About Lena Chow

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Terms of Use

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Preface

(Preface written by Robert L. Michel, Editor of The Dark Report) Clinical laboratory testing plays a crucial diagnostic role in healthcare in the United States. That’s good news for pathologists, laboratory directors, and clinical laboratory scientists.

Numerous new diagnostic tests are available in the clinical marketplace. However, few of these assays possess the right combination of increased sensitivity, reasonable test cost, and the ability to significantly contribute to clinical care.

With the advancements in technology, laboratory test results are helping physicians make earlier and more accurate diagnoses. Numerous new diagnostic tests are available in the clinical marketplace. However, few of these assays possess the right combination of increased sensitivity, reasonable test cost, and the ability to significantly contribute to clinical care. Pathologists and clinical laboratory scientists recognize how important it is that new diagnostic assays fit the following criteria: • Improved sensitivity and specificity over existing lab testing technologies. • Faster turnaround time to a complete result. • Specimen collection methods that are easier to use, safer to transport, and/or have a longer shelf life. • Easier for the laboratory to perform, preferably with automation available. Existence of a correct CPT code for submitting claims, along with established coverage guidelines and reimbursement schedules with most government and private health programs. Whenever all of these criteria are met, it presents clinical laboratories with the opportunity to hit a “diagnostic home run” with referring physicians. An example would the diagnosis of vaginitis. Currently there are several tests available for the detection of the causative agents for vaginitis, but few tests are available for the simultaneous detection of these causative agents from one collected specimen. Such www.darkdaily.com

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a test would be of significant benefit to the clinician and patient, as multiple specimens would not have to be collected.

Ten million times per year, there is an opportunity for the clinical laboratory to step up and improve the diagnosis, treatment, and therapeutic strategies of patients with this condition.

Published statistics indicate that, each year, there are more than 10 million visits to ob-gyn and primary care physicians because of vaginitis. Since this health condition could be caused by a number of different infectious agents, physicians—and their clinical laboratories— must often perform multiple diagnostic tests. That takes time, often doesn’t deliver a definitive diagnosis if the right infectious agent assays were not requested, and can frustrate both physician and patient. Thus, 10 million times per year, there is an opportunity for the clinical laboratory to step up and improve the diagnosis, treatment, and therapeutic strategies of patients with this condition. The following white paper brings together important information specifically designed to help laboratory professionals understand how new molecular technologies can be used in the clinical laboratory, and how their proper use can advance patient care and deliver improved patient outcomes. Every pathologist and laboratory scientist should evaluate this assay and review the clinical guidelines that call for its use in diagnostic and treatment decisions for vaginitis. This white paper is a good starting point. It has been organized to provide an accurate and broad overview of this subject. Please consider the broad range of information presented in this white paper as a starting point for considering how this new diagnostic technology can be used by your clinical laboratory to deliver additional value to referring physicians. We hope it opens a welcome door that enables your laboratory—as a team with your referring physicians—to improve the quality of care delivered to patients in your community. www.darkdaily.com

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Abstract Laboratories have an opportunity to make a measurable contribution to the care of vaginitis patients by offering a turnkey DNA probe test that is not limited by stringent specimen collection requirements and that can simultaneously detect the three pathogens associated with 90% of vaginitis cases in less than an hour. With correct diagnosis, physicians can follow established treatment guidelines and put patients on a path to resolution of the disease, thus reducing some of the frustration associated with inaccurate or incomplete diagnosis due to the limitations of microscopy and other traditional diagnostic methods. The BD Affirm™ VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/vaginosis. The evidence is equally compelling from a business perspective. The test is generally considered “medically necessary” for patients with symptoms of vaginitis and is reimbursed under CPT codes 87480 (Candida), 87510 (Gardnerella) and 87660 (Trichomonas). Customer experience validates that the BD Affirm VPIII Test fits readily into a lab’s workflow, with no requirements for specialized facilities or expertise. The test is well suited to an outreach program since specimen requirements are not stringent—with up to 72-hour stability at ambient temperature depending on the specimen collection device.

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Background These observations point to a lack of understanding of a disease for which effective treatment is available yet often not prescribed because of inaccurate or incomplete diagnosis.

Each year, some 10 million visits to the obstetrician-gynecologist’s office in the U.S. are attributed to vulvovaginitis, an inflammation of the vagina characterized by pain, itching and abnormal discharge.1 Just as significant are the estimated hundreds of millions of dollars spent on over-the-counter treatments and homeopathic drugs for self-diagnosed yeast infection.2 Additionally, some women who seek treatment end up getting counsel from physicians over the phone, even though practice guidelines discourage prescribing vaginitis treatment over the phone or basing treatment on a patient’s self-diagnosis of yeast infection.3 These observations point to a lack of understanding of a disease for which effective treatment is available yet often not prescribed because of inaccurate or incomplete diagnosis. Vaginitis is not a single disease. Three different pathogens account for up to 90% of vaginitis cases. Bacterial vaginosis (BV) is associated with a significant increase in the presence of Gardnerella vaginalis. Candidiasis, or yeast infection, is most commonly associated with Candida albicans. Trichomoniasis is the result of infection by a protozoan, Trichomonas vaginalis.4 Effective treatment is available for each of the three diseases. The key is correct diagnosis (identification of the causative pathogen) and complete diagnosis when multiple diseases are present. A recent study found more than one of the three pathogens in 22% of the vaginitis samples.5 The importance of proper diagnosis is further underscored by growing evidence that links vaginitis to pregnancy complications and increased risk of other infections.4

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Vaginitis Diagnosis: An Opportunity to Improve Patient Care

Favorable reimbursement, combined with the availability of cost-efficient DNA probe technology, offers compelling reasons for laboratories to explore the often-overlooked opportunity in vaginitis diagnosis.



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With the availability of state-of-the-art molecular diagnostics testing that can detect all three pathogens in a single sample in less than an hour, laboratories have an opportunity to play a meaningful role in improving the care of vaginitis patients, reducing the cost of inappropriate or delayed treatment and minimizing unnecessary repeat office visits. Favorable reimbursement, combined with the availability of cost-efficient DNA probe technology, offers compelling reasons for laboratories to explore the often-overlooked opportunity in vaginitis diagnosis.

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The Three Common Underlying Causes of Vaginitis Bacterial vaginosis (BV) is the most common form of vaginitis, accounting for up to 50% of all cases.3 BV is caused by a disruption of the normal vaginal flora. When vaginal pH is increased due to a reduction in the number of lactobacilli, which convert glucose to lactic acid and thus maintain an acid vaginal pH of 3.8 to 4.2, the normal ecosystem of otherwise benign microbial flora is altered. This shift in the normal ecosystem allows over-proliferation of Gardnerella vaginalis, which is an indicator organism for BV.6

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Vaginitis Diagnosis: An Opportunity to Improve Patient Care

Pregnant women positive for T. vaginalis are more likely to have preterm rupture of membranes as well as preterm labor and birth.



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Candidiasis, also called yeast infection, is the second most common cause of vaginitis. About 85-90% of candidiasis cases are caused by Candida albicans and are easily treated with single or short-term doses of medication.4,7 Women with vaginitis symptoms often selfdiagnose and self-treat using over-the-counter antifungal medications. A study of women who purchased over-the-counter antifungal medications showed that only 33.7% of the participants actually had candidiasis.8 Trichomoniasis is the most common non-viral sexually transmitted disease (STD) and is caused by a protozoan, Trichomonas vaginalis.4 Trichomoniasis is associated with increased risk of acquiring HIV and co-infection with other sexually transmitted diseases.4,9 Pregnant women positive for T. vaginalis are more likely to have preterm rupture of membranes as well as preterm labor and birth.4 T. vaginalis is a risk factor for the development of post-surgical gynecologic infections and for the development of post-hysterectomy cuff cellulitis.9,10

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Diagnosis of Vaginitis: Current Practice Just as important, multiple diseases may be present in some vaginitis cases, so initial diagnosis should take into account all three common pathogens associated with vaginitis.

Since effective treatments for vaginitis are available and are specific to the diverse causes of the symptoms, accurate and timely diagnosis is important for providing prompt relief and reducing complications. Just as important, multiple diseases may be present in some vaginitis cases, so initial diagnosis should take into account all three common pathogens associated with vaginitis. The role of microscopy and culture. Traditionally, vaginitis diagnosis is based on a combination of patient history, physical examination and the collection of vaginal samples for pH measurement, amine (whiff) test and microscopy. The presence of “clue� cells (cells with unclear borders, dotted with bacteria) under the microscope is indicative of BV. The diagnosis of candidiasis is based on the visualization of spores, hyphae or yeast buds. Trichomoniasis is also diagnosed by wet mount microscopy, where the presence of motile, flagellated trichomonads is diagnostic.3 If microscopy is performed by the physician, training and time constraints are a consideration. One study found that 42% of physicians did not perform microscopy as part of any evaluation of vaginitis.11 Another limitation is sensitivity. The diagnosis of trichomoniasis using wet mount microscopy to visualize motile trichomonads has a sensitivity rate of only 55-60%.12,13 The diagnosis of yeast based on visualization lacks sensitivity and specificity.14 If microscopy is performed in the laboratory, sample transport and workflow issues impose additional constraints.

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Lab personnel must be available to perform testing of the samples immediately upon their arrival. Culture is often ordered if initial diagnosis based on physical examination, pH or microscopy is ambiguous. (In the case of BV, a Gram stain, based on the Nugent scoring system, is commonly used.15) However, culture can require several days and is expensive. The emergence of point-of-care testing. Tests that are designed for use in the physician’s office are also available. These include the OSOM® Trichomonas Rapid Test (Genzyme Diagnostics, Framingham, MA), which tests for Trichomonas antigen; the OSOM BVBLUE® Test (Genzyme Diagnostics), which measures vaginal sialidases associated with BV but is not specific to G. vaginalis; and the QuickVue Advance® G. vaginalis Test (Quidel Corporation, San Diego, CA), which measures G. vaginalis proline iminopeptidase activity.

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DNA Probe Technology Opens the Door to Improved Vaginitis Care DNA probe technology identifies target organisms in a given sample based on their genetic “ fingerprints” and offers several advantages over traditional techniques…

Accurate, complete and timely diagnosis is the key to appropriate treatment and care of the vaginitis patient. And cost-efficiency must be part of the equation in today’s healthcare environment, where cost pressures are exacerbated by the shortage of trained laboratory personnel. DNA probe technology identifies target organisms in a given sample based on their genetic “fingerprints” and offers several advantages over traditional techniques such as microscopy, culture or Gram stain: (1) results are less dependent on the condition of the sample and independent of morphology, so speed of sample transport is not as critical and refrigeration is not required; (2) results interpretation is objective, not subjective, and not dependent on the reviewer’s expertise; and (3) multiple pathogens can be detected simultaneously using one single sample. Currently, the BD Affirm VPIII Microbial Identification Test (BD Diagnostics, Sparks, MD) is the only test for the simultaneous detection of the three pathogens associated with up to 90% of vaginitis cases.16 The BD Affirm VPIII Test uses nucleic acid hybridization technology. Complementary sequences of DNA in BD Affirm VPIII reagents bind or hybridize only with the nucleic acid of targeted organisms. This hybridization reaction is both highly sensitive and specific, and results in the simultaneous detection and identification of pathogens through clearly visible color reactions. The www.darkdaily.com

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sensitivity and specificity of the BD Affirm VPIII Test are 80.6% and 98.2% for Candida species, compared to culture; 83.8% and 100% for G. vaginalis, compared to Gram stain; and 92.8% and 99.9% for T. vaginalis, compared to wet mount.16 The BD Affirm VPIII Test is significantly more sensitive than microscopy, and comparable to culture for Candida, scored Gram stain for Gardnerella and Diamond’s culture for Trichomonas. Insurance providers generally consider BD Affirm VPIII testing for Trichomonas, Candida and Gardnerella “medically necessary” and reimburse the three separate tests under CPT codes 87480 (Candida), 87510 (Gardnerella) and 87660 (Trichomonas).17

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Implications for Patient Care Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis … remains difficult.

A recent study compared the accuracy of a standardized clinical diagnostic protocol with the BD Affirm VPIII Test. The clinical diagnostic protocol included patient history, pelvic examination, vaginal pH, vaginal fluid amines test and wet prep microscopy. The authors concluded: “Compared with [the BD Affirm VPIII Test], clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis … remains difficult.”5 An earlier study found that “primary care physicians were not as accurate as [the BD Affirm VPIII Test] in diagnosing vaginal infections.”18 In another study, “Affirm VPIII performed significantly better than clinical diagnosis (96% vs. 71% sensitivity, 99% vs. 94% specificity).”19

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Implications for the Laboratory Unlike wet mounts, DNA probe technology does not require immediate attention to samples, making it easier to fit vaginitis testing into the laboratory’s workflow.

For the laboratory, DNA probe technology in general and the BD Affirm VPIII Test in particular offer significant advantages in workflow, facility requirements, staff time and training needs. Unlike wet mounts, DNA probe technology does not require immediate attention to samples, making it easier to fit vaginitis testing into the laboratory’s workflow. Just as important, since samples do not have to be processed immediately, laboratories can offer vaginitis testing at community clinics as part of an overall lab outreach program. (The BD Affirm VPIII Ambient Temperature Transport System [ATTS] offers up to 72-hour stability for ambient temperature use.) Nucleic acid hybridization technology used in the BD Affirm VPIII Test has the further advantage of not requiring specialized facilities, unlike some PCR tests, which may require dedicated facilities to minimize problems of contamination. With the shortage of skilled personnel and increasing labor costs, the level of expertise required to deliver high-quality results is a key consideration. The simple procedure for the BD Affirm VPIII Test does not require specialized expertise, and training is minimal. Hands-on time is 5 minutes per sample. Once the sample is placed in the instrument, the operator can attend to other tasks. DNA probe hybridization and color development do not require operator intervention, and total time to result is less than an hour (or less than 2 hours for a batch of 12 samples). A clearly visible blue bead indicates a positive result.

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Vaginitis Diagnosis: An Opportunity to Improve Patient Care

With reimbursement policies already in place, billing follows standard practice.



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Quality control is integral to the BD Affirm VPIII Test. Two internal controls are included for each test: a positive control and a negative control. These control beads are tested simultaneously with each patient specimen. The positive control ensures the absence of interference; the negative control ensures the absence of non-specific binding from the specimen. Since the BD Affirm VPIII Microbial Identification Test is intended for use in the detection and identification of C. albicans, G. vaginalis and T. vaginalis, laboratories can get started without the more extensive testing and validation necessitated by a “home brew� test. With reimbursement policies already in place, billing follows standard practice.

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Assessing the Opportunity A volume of 1,000 vaginitis cases per year will readily justify a system.

Since vaginitis is a ubiquitous women’s health problem and DNA probe testing may offer a practical solution to delivering accurate, timely results, laboratories have the opportunity to improve patient care in a cost-efficient manner, making a positive impact not only on patient care but also on the laboratory’s financial performance and its reputation with clinicians. The starting point is a systematic review of how current needs for vaginitis care are being served, the ways in which the lab may help improve diagnosis, and the business rationale for implementing DNA probe testing. The following are some key considerations in such a review. Estimated volume The first step is to review the number of vaginitis cases for the healthcare facilities currently serviced by the lab. Many labs serve multiple facilities, including the main hospital in the case of a hospital lab, as well as satellite facilities, community clinics and private practices. This assessment of the potential volume should take into account both the current situation, which is based on the physicians the lab serves today, and a longer-term view, which includes potential for a higher volume if outreach efforts were to be launched. Consider, also, the flexibility to reach out to a larger geographic radius when the methodology does not demand freshly collected specimens. For example, the BD Affirm VPIII Ambient Temperature Transport System (ATTS) offers up to 72-hour stability for ambient temperature use. A volume of 1,000 vaginitis cases per year will readily justify a system.

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Current diagnostic testing

How results are consolidated, reported and billed should also be part of this review, with the goal of uncovering opportunities for improving efficiency in the workflow and information flow as well as charge capture and reimbursement.

A review of current methodology will highlight the issues that can be addressed with a more optimal testing methodology. For example, if diagnostic procedures such as pH and microscopy are being performed at the point of care by physicians, off-loading testing to the laboratory may help alleviate physician workload and make more time available for patient care, as well as improve the accuracy and completeness of diagnosis. If the laboratory performs microscopy, what is the requirement for speedy transport of specimens, and what is the impact on laboratory workflow when trained personnel need to be on standby to review specimens while they are still fresh? A look at the typical turnaround time for Gram stain or culture can also point to levels of clinician satisfaction as well as the implications of delayed treatment on patient satisfaction and the need for return visits. If point-of-care testing is being performed currently, a look at how it fits into the workflow and how results are consolidated across different methodologies can point to opportunities for improving efficiency and quality of results. How results are consolidated, reported and billed should also be part of this review, with the goal of uncovering opportunities for improving efficiency in the workflow and information flow as well as charge capture and reimbursement. Diagnosis and patient management Just as important as objective measures, such as turnaround time, costs and general satisfaction, is the clinician’s confidence in the results and the availability of advanced technology, such as DNA probe testing, to guide treatment and patient care. During this assessment phase, the laboratory can discuss the implications of more accurate and complete diagnosis with clinicians and begin to build a scenario where more accurate and more complete diagnosis can impact patient outcome and enhance the success of the clinical www.darkdaily.com

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practice by improving patient satisfaction and reducing repeat visits that can be time-consuming for the practice and frustrating to patients. Financial review

In addition to estimated volume, a review of current payer contracts and pricing would provide helpful information for making revenue projections.

Dr. Paul A. Granato, director of microbiology for Laboratory Alliance of Central New York, believes that a return on investment (ROI) analysis is of paramount importance in decision making. This begins with a financial review that takes into account the potential revenue in bringing DNA probe testing for vaginitis into the lab as well as the investment that needs to be made. In addition to estimated volume, a review of current payer contracts and pricing would provide helpful information for making revenue projections. The cost to acquire DNA probe testing will include facility setup, installation, training and staff requirements, in addition to instrument and reagent costs. A “plug and play� system that does not require special facilities will save significant up-front costs as well as prevent time delays. An easy-to-use system with minimal training and hands-on operator time may allow the lab to deploy its existing staff instead of adding new recruits, at least while the testing ramps up. This is where speaking to company representatives and soliciting proposals can begin to put the necessary pieces into a financial model. Getting buy-in from stakeholders Introducing a new diagnostic test will require the buy-in of laboratory personnel, the support of clinicians and the approval of administration. Policies and processes differ among institutions, but Dr. Andrea Linscott, director of microbiology at Ochsner Health System (New Orleans, LA), recommends sharing information with managers, section heads and department chairs early in the process and bouncing ideas off colleagues. www.darkdaily.com

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Benefits to patient care, improvements in laboratory efficiency and a positive financial impact are key.



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The new test must be evaluated from multiple perspectives. Benefits to patient care, improvements in laboratory efficiency and a positive financial impact are key. For physicians, a key deciding factor is the accuracy of the results, which will directly impact accuracy of diagnosis and treatment. Some physicians find it reassuring to be able to tell patients that state-of-the-art DNA technology is being applied to diagnose vaginitis. All of these points can help build physician loyalty and confidence that the laboratory is continuing to keep abreast of new developments and offer leading-edge technology. And this goodwill and positive image extend to the institution as a whole.

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Implementing DNA Probe Technology in the Lab The revenue model, operating plan and budget are the blueprint for getting started with DNA probe testing.

The revenue model, operating plan and budget are the blueprint for getting started with DNA probe testing. Some labs have found it useful to conduct process audits and to look for opportunities to implement LEAN Six Sigma improvements in preparation for, and in parallel with, deploying new technology. Expert consultants on the diagnostic manufacturer’s staff are available to provide such specialized services, often with dramatic improvements in productivity and cost-efficiency.

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Marketing New Vaginitis Testing Capabilities Programs targeting meetings of local chapters of physician organizations or efforts to place relevant and high-quality articles in local newspapers to benefit patients can also be effective.

Physician awareness of DNA testing capability and, even more important, the value of accurate and complete diagnosis of vaginitis and its impact on patient care are key. A core program includes a combination of grand rounds, lunch-and-learn and other in-service meetings at community clinics and group practices, and participation in community health fairs, supported by educational materials for physicians, nurses and patients, available from the laboratory in print copies or downloadable from websites. Programs targeting meetings of local chapters of physician organizations or efforts to place relevant and high-quality articles in local newspapers to benefit patients can also be effective. Many clinical diagnostics companies offer counsel and/or materials to help support outreach efforts. Reprints and other educational materials to support physician outreach efforts are often available by request. Patient education brochures are often available for customization with the name and contact information of the laboratory and/or the physician. They can be used by physicians and the office staff to educate patients on vaginitis and DNA probe testing, or distributed at community events to increase public awareness of the importance of proper diagnosis and the lab’s role.

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The BD Affirm VPIII Microbial Identification System at Work The BD Affirm VPIII Microbial Identification System includes the BD Affirm VPIII Microbial Identification Test, the BD MicroProbe Processor and BD Affirm VPIII Microbial Identification Collection Sets.

Six months after installation, the laboratory achieved the goal of 75-minute turnaround time 95% of the time, even though samples come in randomly throughout the day.

CentraCare Health System (St. Cloud, MN) provides comprehensive healthcare services in central Minnesota through three hospitals, four long-term care facilities, nearly a dozen clinics and numerous specialty care services. Women’s health is a focus for the system. The laboratory at CentraCare Health Plaza is one of five laboratories within the system. In June 2008, the laboratory installed two BD Affirm VPIII Microbial Identification Systems to manage the growing volume of vaginitis cases, about 3,000 a year at the time, replacing microscopy as the primary diagnostic method. The overall goal was to improve quality of results by standardizing the testing and providing more objectivity. Deb Reber, clinical laboratory scientist, notes that setup and training on the system took just one day. Six months after installation, the laboratory achieved the goal of 75-minute turnaround time 95% of the time, even though samples come in randomly throughout the day. Another noticeable improvement was the increased number of true positive results for all three pathogens (C. albicans, G. vaginalis and T. vaginalis), as well as the ability to identify multiple pathogens in the same patient specimen. Since the installation of the BD Affirm VPIII Microbial Identification Systems, the number of vaginitis samples has increased steadily, by about 50 tests per month, as more physicians utilize the new testing capability. In the words of one physician, “It’s a nobrainer if you have a better test.”

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Vaginitis Diagnosis: An Opportunity to Improve Patient Care

“With the availability of molecular testing, it just doesn’t make sense to stick to the old, laborintensive, timeconsuming methods that are not as accurate”



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Laboratory Alliance of Central New York (Liverpool, NY), a reference laboratory in Upstate New York, is owned by Community General Hospital, Crouse Hospital and St. Joseph’s Hospital Health Center, with 1,300-plus combined beds. In addition to the three owner hospitals, the laboratory provides services to some regional hospitals and more than 3,000 healthcare practitioners in the area. For more than a decade, BD Affirm VPIII testing has been used for vaginitis testing. Currently, a total of four units are placed at the Rapid Response Laboratory at each of the hospitals and at the central laboratory, performing a total of about 10,000 tests a year. Paul A. Granato, PhD, director of microbiology, notes that the decision to use the BD Affirm VPIII Microbial Identification System was based on the ability to detect all three key pathogens accurately and in less time, as well as the projected ROI. The appeal of DNA probe technology was also a factor. “With the availability of molecular testing, it just doesn’t make sense to stick to the old, labor-intensive, time-consuming methods that are not as accurate,” he adds. The BD Affirm VPIII Microbial Identification System was up and running immediately following installation. At each of the Rapid Response Laboratories, the BD Affirm VPIII System is run on each shift, making results available on a 24/7 basis, typically within hours after the specimen arrives. Ochsner Health System (New Orleans, LA) is an academic, multispecialty healthcare delivery system comprising seven hospitals and more than 35 health centers located throughout southeastern Louisiana. After Hurricane Katrina forced the closure of other area hospitals, Ochsner was absorbing more and more patient load. Working with Alfred Robichaux, III, MD, chairman of the Department of Obstetrics and Gynecology, Wanda Eppling, microbiology supervisor in the Department of Pathology and Laboratory Medicine, brought in two BD Affirm VPIII Microbial Identification Systems to replace wet mounts. Both felt that microscopy was too time-consuming and disruptive to workflow because slides required immediate attention. Also, patients www.darkdaily.com

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Vaginitis Diagnosis: An Opportunity to Improve Patient Care

An added convenience of the DNA probe system is that the lab can handle samples coming from as far as 70 miles away with no concern about sample degradation.



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who saw internists on their initial visit sometimes needed a separate appointment with the ob-gyn department for microscopy. An added convenience of the DNA probe system is that the lab can handle samples coming from as far as 70 miles away with no concern about sample degradation. More important, being able to detect all three pathogens at the same time provides a more complete diagnosis, helping improve patient care. Volume for vaginitis testing continues to grow and is currently at about 1,000 samples per month. Other hospitals in the area are also considering acquiring BD Affirm VPIII Microbial Identification Systems for their laboratories. Parkview Medical Center (Pueblo, CO) is a 305-bed regional hospital and certified level II trauma center serving Pueblo and 14 surrounding counties in southeastern Colorado. Many of the hospital’s patients lack health insurance and, as a result, use the Emergency Department for more routine healthcare needs, including vaginitis. Many of the patients present with serious conditions such as pelvic inflammatory disease and are screened for BV, trichomoniasis and candidiasis as well as other STDs. Microscopy and Gram stain were the main diagnostic tools for vaginitis; both were performed in the lab. Sample quality and subjective results interpretation resulted in many repeats and revisions of reports. In 2004, the lab brought in the BD Affirm VPIII Microbial Identification System. According to Candice Sobanski, MD, medical director for the ED, the lab reports many more positive BV and trichomoniasis results that were previously “indeterminate.” And given the number of walkin patients who may be difficult to track down for follow-up, another benefit is the quick turnaround, which allows the patient to leave the facility with prescription in hand. Test volume has grown steadily and is at about 90 tests per month today. “Getting information from genetic material, rather than from subjective review, is hard to argue with,” notes Lana Fairbanks, microbiology laboratory supervisor. In 2009, the hospital opened a satellite ED 8 miles away and installed a separate BD Affirm VPIII Microbial Identification System. www.darkdaily.com

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Conclusion To assess how the BD Affirm VPIII Microbial Identification Test can fit into your lab, contact your BD representative.

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References 1. Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol 1991;165:1168-1176. 2. Angotti LB, Lambert LC, Soper DE. Vaginitis: making sense of over-the-counter treatment options. Infect Dis in Obstet and Gynecol 2007; article ID 97424. 3. ACOG Practice Bulletin. Clinical management guidelines for obstetrician-gynecologists, Number 72, May 2006: Vaginitis. Obstet Gynecol 2006;107:1195-1206. 4. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Recomm Rep 2006;55:1-95. 5. Lowe NK, Neal JL, Ryan-Wenger NA. Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol 2009;113:89-95. 6. Fredricks DN, Fiedler TL, Marrazzo JM. Molecular identification of bacteria associated with bacterial vaginosis. N Engl J Med 2005;353:1899-1911. 7. Eschenbach DA. Chronic vulvovaginal candidiasis. N Engl J Med 2004;351:851-852. 8. Ferris DG, Nyirjesy P, Sobel JD, Soper D, Pavletic A, Litaker MS. Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis. Obstet Gynecol 2002;99:419-425. 9. Sobel JD. What’s new in bacterial vaginosis and trichomoniasis? Infect Dis Clin N Am 2005;19:387-406. 10. Soper DE, Bump RC, Hurt WG. Bacterial vaginosis and trichomoniasis vaginitis are risk factors for cuff cellulitis after abdominal hysterectomy. Am J Obstet Gynecol 1990;163:1016-1023. www.darkdaily.com

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11. Wiesenfeld HC, Macio I. The infrequent use of office based diagnostic tests for vaginitis. Am J Obstet Gynecol 1999;181:39-41. 12. Pastorek JG II, Cotch MF, Martin DH, Eschenbach DA. Clinical and microbiological correlates of vaginal trichomoniasis during pregnancy. The Vaginal Infections and Prematurity Study Group. Clin Infect Dis 1996;23:1075-1080. 13. Krieger JN, Tam MR, Stevens CE, et al. Diagnosis of trichomoniasis. Comparison of conventional wet-mount examination with cytologic studies, cultures and monoclonal antibody staining of direct specimens. JAMA 1988;259:1223-1227. 14. Abbott J. Clinical and microscopic diagnosis of vaginal yeast infection: a prospective analysis. Ann Emerg Med 1995;25:587-591. 15. Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol 1991;29:297-301. 16. BD Affirm™ VPIII Microbial Identification Test [package insert]. Sparks, MD: BD Diagnostics; 2010. 17. Aetna Clinical Policy Bulletin. www.aetna.com/cpb/medical/ data/600_699/0643.html 18. Ferris DG, Hendrich J, Payne PM, et al. Office laboratory diagnosis of vaginitis: clinician-performed tests compared with a rapid nucleic acid hybridization test. J Fam Pract 1995;41:575-581. 19. Master R, Wolf E, Jones R. Evaluation of the Affirm VPIII Microbial Identification Test for the diagnosis of vaginitis and bacterial vaginosis. In: Abstracts of the 98th General Meeting of the American Society for Microbiology; 1998. Abstract C-165.

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Appendices

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A-1 About Andrea J. Linscott, PhD Andrea J. Linscott, PhD, D(ABMM), is a clinical microbiologist in the Department of Pathology, Ochsner Healthcare System (New Orleans, LA). Prior to joining Ochsner in 2008, Dr. Linscott was the director of the Clinical Microbiology Laboratory and associate professor of pathology at the Louisiana State University Health Science Center in Shreveport, LA. Since 1998, Dr. Linscott has published actively and presented at numerous professional association meetings, academic settings and continuing education symposia. She received her PhD in microbiology from the University of North Texas, Denton.

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A-2 About BD Since 1897, BD has been a leading force in innovating medical devices, equipment, and diagnostic products. Our focus is to reduce the spread of infection, advance global health, advance therapy, and improve disease management. At BD Diagnostics–Women’s Health and Cancer, we provide solutions for early disease detection and diagnostic accuracy in the areas of cervical cancer screening, vaginitis, and STI identification. We offer accurate and innovative solutions for laboratories, health care professionals, and patients that help prevent infection and the spread of cancer through cell- and molecular-based diagnostics. BD is a company of innovators and humanitarians – people who care and who can and will continue to make a difference.

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A-3 About Dark Daily

“Dark Daily is a concise e-news/ management briefing on timely topics in clinical laboratory and anatomic pathology group management. It is a solution to the dilemma facing anyone in the laboratory profession.

DARK Daily is a concise e-news/management briefing on timely topics in clinical laboratory and anatomic pathology group management. It is a solution to the dilemma facing anyone in the laboratory profession. New developments, new technology, and changing healthcare trends make it imperative to stay informed to be successful. At the same time, the Internet, cell phones, blackberries, laptop computers and wireless devices are overwhelming any one individual’s ability to absorb this crushing Tsunami of data. DARK Daily is a quick-to-read, easy-to-understand alert on some key development in laboratory medicine and laboratory management. It has no counterpart in the lab world. Why? Because it is produced and written by the experts at The Dark R eport and The Dark Intelligence Group, who know your world, understand your needs and provide you with concise, processed intelligence on only those topics that are most important to you! You will find DARK Daily to also be an exceptionally valuable resource in laboratory and pathology management. Some of the lab industry’s keenest minds and most effective experts will be offering their knowledge, their insights and their recommendations on winning strategies and management methods. Many of these experts are unknown to most lab directors. As has proven true with The Dark Report for more than a decade, DARK Daily will be your invaluable— and unmatched—resource, giving you access to the knowledge and experience of these accomplished lab industry professionals.

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A-4 About The Dark Intelligence Group, Inc. and The Dark Report

“Membership is highlyprized by the lab industry’s leaders and early adopters. It allows them to share innovations and new knowledge in a confidential, non-competitive manner.

The Dark Intelligence Group, Inc., is a unique intelligence service, dedicated to providing high-level business, management and market trend analysis to laboratory CEOs, COOs, CFOs, pathologists and senior-level lab industry executives. Membership is highly-prized by the lab industry’s leaders and early adopters. It allows them to share innovations and new knowledge in a confidential, non-competitive manner. This gives them first access to new knowledge, along with the expertise they can tap to keep their laboratory or pathology organization at the razor’s edge of top performance. It offers qualified lab executives, pathologists and industry vendors a rich store of knowledge, expertise and resources that are unavailable elsewhere. Since its founding in 1996, The Dark Intelligence Group and The Dark Report have played in instrumental roles in supporting the success of some of the nation’s best-performing, most profitable laboratory organizations. The Dark Intelligence Group (TDIG) is headquartered in Austin, Texas. This location makes it very accessible for any laboratory organization seeking input, insight and support in developing their business operations, creating effective business strategies and crafting effective sales and marketing programs that consistently generate new volumes of specimens and increasing new profits. The Dark Intelligence Group, Inc. owns and operates two Web sites in the TDIG Website network:

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http://www.DarkDaily.com www.darkdaily.com

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A-5 About the Executive War College on Laboratory and Pathology Management Every spring since 1996, the lab industry’s best and brightest gather at the Executive War College on Laboratory and Pathology Management to learn, to share and to network. Many consider it to be the premier source of innovation and excellence in laboratory and pathology management. Each year, a carefully selected line-up of laboratory leaders and innovators tell the story of how their laboratories are solving problems, tackling the toughest challenges in lab medicine and seizing opportunities to improve clinical care and boost financial performance. The Executive War College is the place to get practical advice and solutions for the toughest lab management challenges. A unique case study format brings participants face-to-face with their most successful peers. They tell, first hand, how their laboratory solved intractable problems and successfully used new technology. Many lab management secrets are shared, along with specific “what-not-to-do’s” gained from hard-won experience! It’s not pie-inthe-sky theory, but useful knowledge that can be put to use in any lab. The Executive War College offers superlative networking, with lab administrators and pathologists attending from countries as far away as the United Kingdom, Germany, Brazil and Australia. It makes the Executive War College a melting pot for all the best ideas, new lab technologies and management strategies now reshaping the laboratory industry. It’s also become a recruiting ground used by headhunters and major lab organizations. In the United Kingdom, The Dark Intelligence Group and the Association of Clinical Biochemists (ACB) have co-produced a meeting every February since 2003. Known at Frontiers in Laboratory Medicine (FiLM), it attracts laboratory leaders and innovators in the United Kingdom. Also featuring a case study format, this meeting pioneered the international laboratory side-by-side case study, where a North American laboratory and a United Kingdom laboratory prepare a comparison of best practices and an operational assessment of their two organizations.

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In September 2005, a laboratory management meeting called Executive Edge was conducted in Toronto, Ontario, Canada, by The Dark Intelligence Group and QSE Consulting. It provided pathologists and lab directors in Canada with a customized meeting devoted to the strategic and operational issues of laboratory management in Canada.

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A-6 About Lena Chow

Lena Chow is president of City of Paris, Inc., a healthcare communication consultancy pioneering new agency models and leading the way to more collaborative, efficient and relevant agencyclient partnerships. She is the founder of Lena Chow Advertising, recognized for its award-winning work in communicating complex scientific advances to clinical and business communities. Lena received her BS in chemistry from the University of Hong Kong and did graduate studies in biochemistry at the University of Pennsylvania. She received her MBA from Santa Clara University. www.cityofparis.us

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Notes

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Notes

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Š 2010 by the Dark Intelligence Group, Inc.

Terms of Use: All rights reserved. No part of this report my be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, faxing, emailing, posting online, or by any information storage and retrieval system, with written permission from the Publisher. All trademarks and brands referred to herein are the property of their respective owners.

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Legal Notices While all attempts have been made to verify information provided in this publication, neither the author nor the publisher assumes any responsibility for error, omissions or contrary interpretations of the subject matter contained herein. The purchaser or reader of this publication assumes responsibility for the use of these materials and information. Adherence to all applicable laws and regulation, both referral and state and local, governing professional licensing, business practice, advertising, and all other aspects of doing business in the United State or any other jurisdiction, is the sole responsibility of the purchaser or ready. The author and publisher assume no responsibility or liability whatsoever on the behalf of any purchaser or reader of these materials. Any perceived slights of specific people or organizations are unintentional.

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Vaginitis Diagnosis  

Vaginitis Diagnosis: An Opportunity to Improve Patient Care