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IMPORTANT COVID-19 INFORMATION

Access COVID-19 Test Results: SonicMyAccess

 

IMPORTANT COVID-19 INFORMATION

Access COVID-19 Test Results: SonicMyAccess

Announcements

Announcements

Effective September 4, 2020, Due to a nationwide supply shortage, the Hologic Yellow Urine Aptima Tube cannot be supplied or processed at this time. The pandemic has prompted a massive increase in testing and demand for collection devices spanning from Women’s Health to COVID-19. The vendor is ramping up production of collection devices and manufacturing facilities, adding further manufacturing of penetrable caps and additional sourced options. We apologize for the inconvenience this may cause your practice and will notify you as soon as supply is restored.

Effective September 1, 2020, CPL will implement modifications to our Critical and Alert thresholds for therapeutic drug and toxicology monitoring.

These improvements underwent an extensive internal review and are driven by guidance from literature, instructions from test manufacturers and a selected survey of laboratories. As always, CPL works to establish critical and alert analytes and thresholds as a foundation for our client base, balancing the notification of a potential threat to patients against oversaturation of client alert notifications.  We encourage all clients to critically review our Critical and Alert policy, analytes, and thresholds, to determine if they are suitable for your patient population or require customization.  Please contact your CPL Account Representative for more information.

AUSTIN, Texas, July 22, 2020 /PRNewswire/ -- A new validation study published today, "Thyroid Cytology Smear Slides:  An Untapped Resource for ThyroSeq Testing", provided extensive validation of cytology smears as an acceptable alternative for ThyroSeq® GC testing in patients with indeterminate thyroid cytology.  The study was performed at UPMC and the University of Pennsylvania and reported in Cancer Cytopathology.

ThyroSeq, commercially available through Sonic Healthcare USA and their network of clinical laboratories and pathology practices throughout the United States, is a comprehensive molecular test for thyroid nodules and cancer that is typically performed using a sample collected during a fine needle aspiration (FNA) procedure. 

In this study, ThyroSeq performance was assessed in routinely prepared air-dried Diff-Quik® and alcohol-fixed Papanicolaou stained cytology smears and compared to the test results obtained using freshly collected FNA samples from the same nodules. 

The study showed that more than 80% of routinely prepared cytology smears, including all alcohol-fixed Papanicolaou stained smears, could be successfully used for ThyroSeq testing to assess multiple types of genetic markers and provide accurate test results in thyroid nodules with indeterminate cytology.

"The results of this two-institutional study expand the range of acceptable sample types for ThyroSeq Genomic Classifier," said Marina Nikiforova, MD, Professor of Pathology and Director of Molecular and Genomic Pathology Laboratory at University of Pittsburgh Medical Center, and lead author of the study. "This will enable more patients to benefit from ThyroSeq testing, save expenses associated with a second office visit and repeated FNA biopsy, while offering high diagnostic accuracy needed to improve patient management."

The ThyroSeq test can help avoid costly diagnostic thyroid surgeries by reliably distinguishing between benign and cancerous thyroid nodules. When a dedicated sample is not collected for molecular testing at the time of FNA procedure, cytology smears may be the only specimens available.  Expansion of ThyroSeq testing to cytology smears means that patients with indeterminate cytology will not have to come back into a physician's office to have another sample taken, instead the available smears can be sent for testing.  Previously validated and acceptable specimen types for ThyroSeq include fresh FNA samples collected into ThyroSeqPreserve solution, which remains the gold standard of specimen quality, cytology cell blocks, and formalin-fixed and paraffin-embedded tissue. This study demonstrates that ThyroSeq can be performed using routine cytology smears, while maintaining the robust diagnostic accuracy.

Link to validation study can be found here: Cancer Cytopathology

 

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year.  Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and over eight thousand US-based employees.  Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

About ThyroSeq

ThyroSeq® Genomic Classifier is an innovative test for thyroid nodules and cancer that utilizes next-generation sequencing technology to analysis both DNA and RNA collected from a thyroid nodule to generate comprehensive genomic profiling of cells and uses a proprietary genomic classifier, to provide comprehensive diagnostic and prognostic information on the nodule, empowering physicians to individualize patient management.  With more than a 10-year history of continuous refinement, it incorporates all major scientific discoveries and technological advances to offer the most accurate diagnosis of benign or malignant disease in thyroid nodules.

MEDIA CONTACTS:
Sonic Healthcare USA
Dr. Jerry Hussong, MD, MBA
Chief Executive Officer
jhussong@sonichealthcareusa.com
512.531.2216

In an effort to decrease the administrative burden on our client’s practices, NT-proBNP and D-dimer will no longer be included in CPL’s foundational Alert notification list. Unless ordered STAT, elevated values will be no longer be manually called as a laboratory Alert. As always, each practice should be aware of CPL’s Alert and Critical policy, analyte list, and thresholds to determine if these are appropriate for your patient population. Please contact your CPL Account Representative for more information.

Sonic Healthcare USA Signs Exclusive License Agreement with UPMC for Broader Patient Access to the ThyroSeq® Genomic Classifier

Austin, TX – November 5th, 2019 

Sonic Healthcare USA (Sonic) and UPMC have entered into an exclusive long-term, 15-year license agreement for access to ThyroSeq® Genomic Classifier.  The test has already been commercially available through CBLPath, a Sonic Healthcare Division, but will now be available through all of Sonic’s Clinical Laboratories and Anatomic Pathology practices across the United States.  CBLPath will continue to offer ThyroSeq and FNA interpretation with their team of expert cytopathologists, and as a leading provider and established center of excellence for thyroid cytology and molecular services.

The ThyroSeq Genomic Classifier is a next-generation sequencing-based test that utilizes DNA and RNA from thyroid cells collected during a Fine Needle Aspiration (FNA) procedure to improve the management of patients with thyroid nodules of indeterminate cytology. It distinguishes between benign and cancerous nodules and also provides specific genetic alteration information to guide individualized patient management, which may include determining the appropriate extent of surgery and selection of targeted therapies for specific patients. 

“This test offers patients and physicians a different level of information than previously provided, allowing the physician team to tailor the immediate and long-term care plan for these patients”, said Carlos D. Urmacher, MD, FCAP, FASCP, President of CBLPath. 

Sonic exhibited last week at the 89th Annual Meeting of the American Thyroid Association® in Chicago, Illinois, where updated data was presented on the clinical utility and performance of the ThyroSeq test.  Sonic Healthcare USA sponsored an Expo Theater Session on Friday, November 1, 2019, which highlighted ThyroSeq’s validated diagnostic accuracy in cytology smears, cost-effectiveness of molecular testing versus diagnostic lobectomy, and performance in Hürthle Cell Nodules. 

“We are very pleased to solidify our partnership with Sonic Healthcare, facilitating the expansion of patient and physician access to ThyroSeq”, said Yuri Nikiforov, MD, PhD, and Vice Chair of the Department of Pathology and Director of Molecular Genomic Pathology at UPMC.  “Sonic’s extensive federation of Clinical Laboratories and Anatomic Pathology practices coupled with the recent expansion of validated acceptable sample types will enable more patients to benefit from ThyroSeq testing.” 

Jerry Hussong, MD, MBA and Chief Executive Officer of Sonic Healthcare USA said, “As a company at the forefront of diagnostic medicine, the addition of ThyroSeq to our robust cytology and molecular services throughout the United States aligns itself well with our continued focus and emphasis on advancing innovations to deliver high-quality patient care.  The ThyroSeq test can help avoid costly diagnostic thyroid surgery by distinguishing between benign and cancerous thyroid nodules and is also validated for cytology smears, which is especially important when a dedicated sample is not collected for molecular testing.” 

 

About Sonic Healthcare USA 
Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com. 

About CBLPath, Inc. 
CBLPath, a Sonic Healthcare Company, is a leading provider of sub-specialized anatomic pathology and molecular diagnostic laboratory services. In addition, CBLPath is a Center of Excellence in the interpretation of fine needle aspiration (FNA) of thyroid nodules having a staff of expert cytopathologists dedicated to the interpretation of over 40,000 thyroid FNAs annually. For more information, please visit www.cblpath.com. 

About ThyroSeq 
ThyroSeq® Genomic Classifier is an innovative test for thyroid nodules and cancer that utilizes next-generation sequencing technology and a proprietary genomic classifier to analyze 5 classes of alterations in DNA and RNA collected from a thyroid nodule, with reported results empowering physicians to individualize patient management. With more than a 10-year history of continuous refinement, it incorporates all major scientific discoveries and technological advances to provide the most accurate diagnosis of benign or malignant disease in thyroid nodules. 

Clinical Pathology Laboratories, Inc Notifies Patients of a Data Security Incident

Clinical Pathology Laboratories, Inc. Notifies Patients of Data Security Incident

Austin, TX — July 12, 2019—Clinical Pathology Laboratories, Inc. (“CPL”) has been informed by Retrieval Masters Creditors Bureau d/b/a American Medical Collection Agency (“AMCA”) of a data security incident involving the AMCA payment website. AMCA is an independent collection agency that CPL and many other entities used for debt collection. The incident is limited to AMCA’s systems. The security of CPL’s systems was not affected by this incident.

According to AMCA, on March 21, 2019, AMCA became aware of facts indicating there had been a data security incident. After conducting an investigation, in May of 2019, AMCA notified CPL about the incident and informed CPL that an AMCA database containing information for some CPL patients had been affected. However, at the time of AMCA’s initial notification, AMCA did not provide CPL with enough information for CPL to identify potentially affected patients or confirm the nature of patient information potentially involved in the incident, and CPL’s investigation is on-going. Based on the information provided by AMCA, the following information belonging to CPL patients may have been affected by the incident: patient names, addresses, phone numbers, dates of birth, dates of service, balance information, credit card or banking information and treatment provider information. AMCA has advised CPL that its patients’ social security numbers were not involved in the incident. CPL does not provide AMCA healthcare records such as laboratory results and clinical history. The impact of this incident is limited to patients whose accounts were referred for debt collection and who reside in the United States.

Individuals with questions about this incident or questions about precautionary steps they can take may call 833.300.6927 or visit https://ide.myidcare.com/CPL for additional information.

CPL takes the security of its patients’ information very seriously, including the security of data handled by vendors. The privacy and protection of patient information is a top priority. As a result of the investigation, CPL is no longer using AMCA for collection efforts.

CPL greatly appreciates the patience and loyalty of its patients as it works to respond to this incident.

While we are unaware of the misuse of any patient’s information, we are providing the following information to help those wanting to know more about steps they can take to protect themselves:

 

What steps can I take to protect my personal information?

  • If you detect any suspicious activity on any of your accounts, you should promptly notify the financial institution or company with which the account is maintained. You should also promptly report any fraudulent activity or any suspected incidents of identity theft to proper law enforcement authorities.

  • Obtain a copy of your credit report, free of charge, directly from each of the three nationwide credit reporting agencies.  To do so, free of charge once every 12 months, please visit www.annualcreditreport.com or call toll free at 877.322.8228. Contact information for the three nationwide credit reporting agencies is listed at the bottom of this page.

  • Please notify your financial institution immediately of any unauthorized transactions made or new accounts opened in your name.

  • You can take steps recommended by the Federal Trade Commission to protect yourself from identify theft. The FTC’s website offers helpful information at www.ftc.gov/idtheft.

  • Additional information on what you can do to better protect yourself is included in your notification letter.

What should I do to protect myself from payment card/credit card fraud?

We suggest you review your debit and credit card statements carefully for any unusual activity.  If you see anything you do not understand or that looks suspicious, you should contact the issuer of the debit or credit card immediately.

How do I obtain a copy of my credit report?

You can obtain a copy of your credit report, free of charge, directly from each of the three nationwide credit reporting agencies. To order your credit report, free of charge once every 12 months, please visit www.annualcreditreport.com or call toll free at  877.322.8228. Contact information for the three nationwide credit reporting agencies is included in the e-mail and letter, and is also listed at the bottom of this page:

How do I put a fraud alert on my account?

You may consider placing a fraud alert on your credit report. This fraud alert statement informs creditors to possible fraudulent activity within your report and requests that your creditor contact you prior to establishing any accounts in your name. To place a fraud alert on your credit report, contact Equifax, Experian or TransUnion and follow the Fraud Victims instructions. To place a fraud alert on your credit accounts, contact your financial institution or credit provider. Contact information for the three nationwide credit reporting agencies is included in the letter and is also listed at the bottom of this page.

Contact information for the three nationwide credit reporting agencies is as follows:

Equifax Security Freeze
PO Box 105788
Atlanta, GA 30348
800.685.1111
www.equifax.com

Experian Security Freeze
PO Box 9554
Allen, TX 75013
888.397.3742
www.experian.com

TransUnion (FVAD)
PO Box 2000
Chester, PA 19022
800.888.4213
www.transunion.com

 
Introducing the New CPLLABS.COM

Clinical Pathology Laboratories (CPL) is proud to introduce our newly redesigned website, CPLLABS.COM.

A new look and feel allow for an enhanced user experience that gives you easy access to the information you need, wherever you are, while providing the same great service you have come to expect from CPL.

The primary objectives of our site development effort were focused on aesthetics, simplifying our content, and increasing the visibility of our programs. The new design also allows for streamlined menus, clear navigation, and a responsive layout for all platforms creating a user-friendly browsing experience for our valued customers and business partners.

We placed the upmost importance on providing a restructured and simplified navigational experience, providing quick links to some of the most central areas of our site. Whether you need to pay a bill, find pertinent test information, or need answers to questions, the new CPLLABS.COM makes it easier to find what you are looking for. In addition to our extensive menu of test offerings, customer support and online services, the new CPLLABS.COM is a fully-functioning mobile website that performs the same whether you are on a tablet, cell phone or laptop.

Whether on desktop or mobile, our updated site will provide an elevated experience. Our “Locations” section provides detailed information for our 250 patient service centers. You can now navigate directly to your nearest CPL draw site which integrates seamlessly with your smartphone or mobile device.

Health care providers can get details about the services CPL offers in the “Clinicians” section. Here, you will find state specific insurance lists, Medicare tools, information on connectivity and clinical solutions, ICD-10 coding reference materials, collection guides and more.

The “Patients” section now provides patients details about what to expect when coming in for lab work, FAQs, educational material, access to our secure results portal and online bill pay. We are constantly adding and updating the content to ensure that we continue to provide the most up to date and relevant information to our patients.

Thank you for choosing Clinical Pathology Laboratories for all your laboratory testing needs. We hope you enjoy our new user-friendly design. If you have any questions about the new website, please contact us and give your feedback. We look forward to hearing from you.

Vitamin D Coverage Policies

Aetna®, Cigna®, UnitedHealthcare® Community Plan and other commercial insurance providers have recently published coverage policies for Vitamin D testing and, in some circumstances, may no longer cover Vitamin D testing. The newly published coverage policies describe reimbursement for Vitamin D testing including a brief overview, instructions for use, medical necessity, general background information, and ICD-10 codes which are defined by the policy as medically supportive. Individual plans may vary. As always, for the most accurate coverage policy for each patient, please contact the patient’s health plan. 

Tests affected by the policy
Test NameUnit CodeCPT Code
Vitamin D, 25 Hydroxy495882306
Vitamin D, 1, 25 Dihydroxy4960823652

 

 The ICD-10 codes listed below are the top diagnosis codes currently utilized by ordering physicians for the tests indicated above that are also listed as medically supportive under these commercial policies. If ordering these tests for diagnostic purposes that are not covered under the policies, patients may be responsible for payment. The policies specify covered ICD-10 diagnosis codes with a note that the list of codes may not be all-inclusive and that deleted codes which are not effective at the time of service may not be eligible for reimbursement. 

Most common appropriate ICD-10 code descriptions
 
CodeDescriptionCodeDescription
E21.3Hyperparathyroidism, unspecifiedM06.9Rheumatoid arthritis, unspecified
E55.9Vitamin D deficiency, unspecifiedM81.0 Age-related osteoporosis without current pathological fracture
E83.51HypocalcemiaN18.2Chronic kidney disease, stage 2 (mild)
E83.52HypercalcemiaN18.3Chronic kidney disease, stage 3 (moderate)
K50.90Crohn’s disease, unspecified, without complicationsN18.4Chronic kidney disease, stage 4 (severe)
K51.90Ulcerative colitis, unspecified, without complicationsN18.9Chronic kidney disease, unspecified
K90.0Celiac diseaseZ79.899Other long term (current) drug therapy
K91.2Postsurgical malabsorption, not elsewhere classifiedZ98.84Bariatric surgery status

 

 Full Vitamin D coverage policies from the commercial insurers listed above can be accessed in the following links: 

AETNA Cigna UHC Community Plan

 Disclaimer: ICD-10 diagnosis codes are subject to change. Please see the insurers’ full vitamin D coverage policy for current diagnosis codes considered medically necessary. 

View Printable PDF

Cervical Screening at CPL

Clinical Pathology Laboratories is one of two US - and two Irish - laboratories that have provided Pap smear testing for the Irish cervical screening program since 2008, and CPL served the program from 2010 to 2013.

Since 2008, more than 3 million screening tests were performed by the four laboratories contracted by the Irish Health Services Executive (HSE). This testing was performed to the highest quality standards in order to assure the best possible outcomes for the women participating, and the HSE screening program has identified and treated cervical cancer and its precursors in more than 50,000 women.

The results of cervical cancer screens conducted by our lab and the three other labs are well above the accepted accuracy rate for the type of screening conducted and have been continuously monitored and repeatedly endorsed by Irish health authorities as well as US laboratory accrediting agencies.

CPL has a greater than 70-year history of providing high quality medical testing including cervical cancer screening. Our service is directed by physician pathologists; we adhere to the highest clinical standards, and we are regularly reviewed by the appropriate U.S. governmental and private accrediting agencies. The standard of Pap test screening in the US, including that provided by CPL, is among the best in the world and utilizes a combination of technologies including computer-assisted image analysis and concurrent or reflex HPV testing in accordance with US national guidelines.

Mark Silberman, M.D., Laboratory Director of Clinical Pathology Laboratories states, "At CPL we strongly believe in screening as an invaluable service to identify those at increased risk for cervical cancer and other life-altering diseases. We take particular pride in the quality of our services in women's health."

 Download the PDF version of Cervical Screening at CPL - Press Release

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Clinical Pathology Laboratories and Premier Patient Network Partner with innovative, Integrated Technology to deliver better patient care

DALLAS, Texas (September 09, 2015) - Premier Patient Network (PPN) and Clinical Pathology Laboratories (CPL) today announced an innovative partnership leveraging technology to deliver better patient care. CPL and PPN are expanding the role of laboratory medicine within the care team by bridging the data gap to bring actionable, real-time information to providers for improved patient care and outcomes.

In the push for meaningful use and widespread adoption of electronic health records (EHR), healthcare is clogged with countless independent systems incapable of communicating or sharing data in purposeful ways. PPN, a Dallas-based accountable care organization and group of more than 880 physicians, and Austin-based CPL, the largest U.S. laboratory in the Sonic Healthcare federation, have created a solution: melding proprietary technologies from each organization to give physicians a critical edge to facilitate healthier patient outcomes.

Through the power of predictive diagnostics and innovative patient engagement technologies, the program merges the best of PPN's 360 dashboard, a powerful population health management tool, and CPL's iMorpheus®, a real-time healthcare informatics tool providing clinical insights through its proprietary pattern recognition capabilities. 

"Clinical data drives diagnosis, disease monitoring, treatment selection and chronic disease risk evaluation, but only if we can access it in a timely manner," said Anwar Kazi, CEO of Sybrid, the managing partner of PPN's accountable care organization programs.

The new population health informatics program provides physicians a powerful tool to identify under-diagnosed and under-managed conditions in their patients, and better address them in a timely manner. This level of coordinated care management creates better health for patients while controlling overall costs. It is a key benefit for managing chronic illnesses like diabetes, which often require many lab tests to manage the disease.

"This joint technology integration empowers physicians to focus more on using the right data at the right time in delivering the highest quality of care across all patient touch points," said Steve Shumpert, president of CPL. "Our goals and business philosophy of empowering the independent primary care physician mirror those of Premier. We've been serving physicians and patients in Texas since 1948."

The program will deliver a real-time tool that helps physicians leverage laboratory insights and other medical data to:

  • Identify gaps in care and prioritize patients who need care the most
  • Aid in patient diagnosis, assess risk, and monitor patient progress
  • Improve Medicare quality reporting
  • More easily generate shared savings under the Medicare Shared Savings Program
  • Utilize real-time data to deliver actionable insights that improve care coordination efforts
  • Create impactful care and treatment plans in real-time during patient visits
  • Better engage patients in their own wellness, creating better health and quality of life
     

Physicians will save time and have a more cohesive view of a patient's case through a single interface rather than having to juggle multiple downloads and manual charts. Additionally, the new program allows physicians to process data in a way that simplifies paperwork needed for the Medicare Advantage and Medicare Shared Savings Programs. PPN created $11.9 million in shared savings in 2014. As this new integrated technology is utilized, even more savings are expected.  

The partnership between PPN and CPL underscores the goals of accountable care organizations. The nation is moving away from a cottage industry health system to more cooperation with physicians and ancillary providers. Fragmented care has given way to continuum care, with a coordinator incentivized to drive efficiencies in a patient's care management journey. 

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About Premier Patient Network

Premier Patient Network (PPN) is a newly formed alliance of two physician-owned, physician-led organizations: Premier Patient Health Care and Patient Physician Network of Plano. The alliance provides independent physicians a support vehicle for practicing in a value-based environment where technology, support resources, and contracting economies of scale are imperatives. For more information, visit www.premierphc.com. 

About Clinical Pathology Laboratories

Clinical Pathology Laboratories (CPL) is a physician-led member of the Sonic Healthcare federation of laboratories providing national support on a local level. It has served physicians and patients in Texas since 1948. Its mission is to serve the medical community with the highest quality laboratory services, catering to the individual needs of independent practicing physicians. CPL upholds the values and operating philosophies of medical leadership, personalized service to physicians and a commitment to the highest quality laboratory testing. For more information, visit www.cpllabs.com. 

Disclaimer: ICD-10 diagnosis codes are subject to change. Please see the insurers’ full vitamin D coverage policy for current diagnosis codes considered medically necessary.

Download a PDF version of this Premier-CPL Press release