Archive for the ‘Uncategorized’ Category

Long-Travel Piezomotors: New Innovations, New Solutions

February 13, 2012

This newly announced technology has the potential to be a disruptive game-changer for creating a new generation of ultra-fast, “personal” WSI scanners. Stay tuned for more on this.

Read full story.

by Scott Jordan and Stefan Vorndran, PI (Physik Instrumente) L.P., www.pi-usa.com; posted by Chris Warner | Tuesday, February 7, 2012 (ECN)

In a variety of fields, applications are placing conflicting demands on structural and motion subassemblies. Increasingly, positions must be controlled in more degrees of freedom with higher dynamic and static accuracy, yet faster throughputs and longer travels are necessary to meet financial metrics. Compactness is prized, yet high speeds are demanded. These conflicting requirements have, until recently, had no solution. Application examples abound: 

• Optic assemblies of escalating sophistication require multiple axes of nano-precision alignment, yet they must remain aligned for months of around-the-clock use. 

• Emerging nanoimprint lithographies demand exquisite positioning and trajectory control, yet they must retain alignment integrity under significant physical and thermal stresses. 

• Applications ranging from cell-phone cameras to endoscopy and fluid 
delivery require exceedingly small but stiff and responsive and reliable positioning of optics, probes, shutters and other small loads. 

Fortunately, a confluence of new piezo-based approaches has breathed new capability into the nano- and micro-positioning world. Some of these represent significant incremental advancement of essentially traditional mechanisms; others represent significant forks in the road of positioning technology. 

Read full story.

Docs Going Mobile

January 17, 2012

Courtesy of Dark Daily:

QuantiaMD’s survey confirms that physicians will increasingly seek real-time connectivity and consultation with medical laboratory service providers

Physicians are quickly becoming fans of mobile computing. Clinical laboratory managers and pathologists will be interested to learn that, in fact, mobile computing is taking hold among physicians faster than in the general population.

This was one conclusion from a recent survey, according to an article in Healthcare InformaticsQuantiaMD, a Waltham, MA-based mobile and online physician community, conducted a survey of 3,798 physicians. More than 80 % of the respondents said they own a mobile device capable of downloading applications. That means that a far higher percentage of physicians are using mobile devices than among the general public.

Read more at Dark Daily.

Computer ‘Pathologist’ Could Help Assess Breast Cancer Survival

November 15, 2011

Model under study may someday help, not replace, physicians, researchers say

November 9, 2011

In light of FDA comments on the same day these are the kind of tools and technologies that are additive to a pathologists' toolbox to appropriately diagnose and try to predict clinical behavior with morphology that digital pathology offers. In addiiton to what we can recognize — cell morphology, nuclear morphology, mitoses, tubules, stroma, etc… but there are a lot of details we cannot see with light microscopy alone and computer algorithms can help us with.  No way a single pathologist can accurately, reproducibly and consistently assess 6,000 cellular features on dozens of slides.  Early results on a limited number of patients but this looks promising.  Stay tuned.

By Kathleen Doheny
HealthDay Reporter

WEDNESDAY, Nov. 9 (HealthDay News) — A new computer model analyzes microscopic breast cancer images and predicts patient survival better than the pathologists who do the job now, new research suggests.

The computer program "provides information above and beyond what the physician provides, using the same data," said Daphne Koller, a professor of computer science at Stanford University and senior author of the study. The computer model is called Computational Pathologist, or C-Path.

Although the technique needs much more study, it may someday supplement analysis of breast cancer by pathologists, who use a process that has remained largely unchanged for 80 years, said Koller.

With the traditional method, pathologists examine a tumor visually under a microscope and score it according to an established scale. The scores help doctors figure out the type and diversity of the cancer. From that information, they calculate the outlook and course of treatment.

The pathologists' determination relies on three factors: what percent of the tumor is made up of tube-like cells; the diversity of the nuclei in the outer cells; and how often those cells divide.

But the system is subjective, said the study authors, whose computer model found that additional factors may influence survival. The study is published Nov. 9 in Science Translational Medicine.

Using the C-Path image analysis program, Koller's team trained the computer to analyze biopsied breast cancer tissue and to determine the cancer features that matter most and least in predicting survival.

The computer model looked at more than 6,000 cellular factors and found that characteristics of the cells surrounding the cancer — the cancer's environment — are also important in predicting survival.

"We found 11 [factors] ultimately that showed the most robust association with survival," said Dr. Andrew H. Beck, an assistant professor of pathology at Harvard Medical School, in Boston. He is the lead author of the study, done while he was a doctoral student at Stanford School of Medicine.

The researchers applied the C-Path system to images from two groups of patients with breast cancer. One group, from the Netherlands, included 248 people. The other, from Vancouver, Canada, had 328 patients.

The prognostic score generated by C-Path was strongly associated with survival in both groups, Koller said. The groups predicted to be high risk by C-Path were more likely to die in a given year than those predicted to be low risk, she said.

C-Path would help, not replace, pathologists. "We see it ultimately as a complementary approach," said Beck.

Neither Stanford nor the researchers has begun commercial development of the method, Koller said.

In a commentary accompanying the study, Dr. David L. Rimm, professor of pathology at Yale University School of Medicine, called the research ''landmark" work.

"C-Path potentially is the first truly objective, quantitative grading system for cancerous tissue and its surrounding stroma [connective tissue]," he writes.

However, Rimm and other experts agreed that further research is needed. "This isn't quite ready for prime time," he said.

Dr. Anil V. Parwani, a pathologist and division director of pathology informatics at the University of Pittsburgh Medical Center, said: "It (C-Path) has interesting potential and provides a novel look. The results are interesting, but the study is limited."

More information

To learn more about breast cancer, visit the College of American Pathologists.

Copyright © 2011 HealthDay. All rights reserved.

Tags: breast cancer, research, cancer, computers

 

A letter to digital pathology companies from a group of pathologists for digital pathology

November 7, 2011

Dear manufacturer,

We are a group of pathologists who appreciate your vision, inventions and innovations.  There is unlikely more than a handful of pathologists who on some level do not realize the advantages of digital pathology when compared with light microscopy.  The ability for multiple people to view the same slide at the same time, independent of slide or pathologist location and consult with colleagues or view remote slides to assist in patient care remains one of single greatest innovations in the day-to-day practice of pathology over the past several decades.  

PathvuIn our practice currently, we use video or scanner generated images to render diagnoses for remote frozens, immediate fine needle aspirations, image analysis, image morphometry, consults across our group or to other specialists and experts, virtual IHC, virtual consults, education, conferences, tumor boards and research.  It has been a useful adjunct technology just as IHC, improved laboratory information systems, voice recognition technologies and molecular techniques have. 

It is a rare day when an image other than that generated from a microscope itself is not used in some fashion to support the work of our pathology group caring for our patients.  

Multiheadmicroscope

We understand that last week the FDA and others presented at a panel at the annual Pathology Visions supported by the Digital Pathology Association (DPA) and others to review the requirements on regulating devices and software that comprise a digital pathology system.

We have been following this discussion since industry representatives and pathologist leaders in digital pathology met in October of 2009.  At that meeting we believe the FDA stated WSI systems are not class 1 exempt and therefore subject to pre-market approval (PMA).  Topics such as intended use which the FDA relies heavily upon, nature of the systems, patient safety and effectiveness were discussed in the available presentation entitled "Digital Pathology Devices Panel Meeting" presented by a FDA representative.

Prior to that meeting, specific clearances were given for image analysis and digital read applications for HER2 and PR were given a "green light" by the FDA.  More recently, another digital pathology system in addition to the slide stainer and immunohistochemical stain for HER2 were given the "go ahead" for digital reads.

In the past two years between public discussions, it is also our understanding that a DPA FDA Task Force representing a coalition of industry leaders has been in discussions with the FDA and projects such as "Project Pink" have been conducted to add to the body of knowledge towards clearance of whole slide imaging for primary H&E diagnosis.  

This is the good news.  The bad news now seems that despite not hearing much since October of 2009 we now know that these devices and systems will be regulated as Class 3 devices for primary H&E diagnosis although no mention of education, research, tumor board, previously cleared image analysis and interpretations nor consultations was discussed.  Additionally, a representative from CMS (which manages CLIA) stated that whole slide imaging could not be self-validated within a U.S. laboratory setting.

Our group has a difficult time reconciling prior clearances for immunohistochemical stains and no mention of consultations, which in many cases may represent the "primary" diagnosis that precedes a treatment and/or management plan or appropriate follow-up (this of course is the very reason someone is actually consulted in the first place much like any other specialty or industry that relies on sub-specialists to answer specific questions – in the case of pathology it is a diagnosis) and now a requirement for primary H&E diagnosis.   

Nonetheless, now we can stop worrying about what the FDA was going to say and prepare to cross this barrier with you.

While primary H&E diagnosis may not be our primary application we have no reservations about using it for such and offer our services to assist with your submissions.  Like thousands of laboratories in this country, we accession thousands of specimens annually and generate tens of thousands of slides from a broad range of specimen and part types encompassing a wide range of diagnoses, both neoplastic and non-neoplastic in nature.  We all recognize this is an important part of the diagnostic process but is best when used in conjunction with past medical history, clinical history, presentation, family history (when applicable) and gross clinical or surgical findings.  Fortunately, this information is commonly available or presented at the time of biopsy or surgery.  We are use to validating tests, technologies and procedures. CAP, CLIA and JCAHO accreditation mandate competency for laboratories for successful inspections and accreditations.  It happens on a daily basis.  Pathologists are also the consummate physicians when it comes to self-regulation and validation in terms of proficiency testing, internal quality assurance, mandatory internal peer reviews and external reviews in the best interests of diagnostic accuracy and patient safety.  As you know, much of this is commonly being done with digital pathology today.

Fortunately, more good news for both you as a provider of technology and we as consumers know that there is a long history of being able to make an H&E diagnosis off a computer monitor. In fact, many of us remember this newspaper headline from 1986 (Colburn D. The next best thing to being there.  And now, diagnosis by satellite. Washington Post 1986;August 27:7 – click on image to enlarge):

                               Satellitediagnosis

Since this proof-of-concept was successful, a search of PubMed for terms such as "digital pathology", "telepathology" and "whole slide images" reveals hundreds of peer-reviewed studies and publications with thousands of cases studied showing the effectiveness and validity of H&E diagnoses rendered with images on a computer monitor compared with conventional light microscopy.  A few historic notables include work done by the Veterans Administration Healthcare System (Dunn), University Health Network (Evans) and the U.S. Military Healthcare System (Kaplan) as examples of early validations and ongoing remote primary H&E diagnostic pathology services.

More recently, several peer-reviewed articles have been published suggesting that whole slide images offer not only equivalent accuracy when compared with "truth diagnoses" but actually may be superior to conventional microscope reads and offer not only better diagnoses but access of the right slide to the right person at the right time (i.e. primary diagnosis) in addition to the "same slide, same time" value proposition (i.e. secondary consultation) and more offer more intangibles not possible with glass slides alone.

A study in e-pub ahead of print in Clin Transplant (2011 Sep 29) looking at Banff score reproducibility from several folks at the University of Alberta who know a thing or two about this as they wrote the guidelines recently published "Superiority of virtual microscope versus light microscopy in transplantation pathology".  The authors conclude "The agreement for acute rejection between virtual and glass slides was not different from the agreement between two readings of glass slides. Thus, virtual microscopy is a reliable and more reproducible technology and has several advantages over glass slides, e.g., accessibility via internet, no fading. We recommend virtual microscopy for transplant diagnostics, including utilization for clinical trials."  

A group of researchers in France recently published "Prostate needle biopsy examination by means of virtual microscopy" and concluded "Virtual microscopy does not compromise, but might improve, the accuracy of grading in prostate needle biopsies".  

Thirdly, a collaboration of researchers in Denmark recently looked at "Automated digital volume measurement of melanoma metastases in sentinel nodes predicts disease recurrence and survival".

Last, but not least, multiple clinical investigators from several institutions and laboratories in Pittsburgh and Indianapolis recently published their experience with "Interinstitutional and interstate teleneuropathology". Lessons learned from this successful venture can be used to facilitate future efforts in this ever-growing practical vehicle for distributing pathology subspecialty expertise.

The time has come.  

To these pioneers we say, you are welcome to read our kidney transplants that are "rule out rejection" or compare thousands of our prostate biopsies and prostatectomies to insure accurate Gleason grading. Clearly we alone with our microscopes cannot automate volume of metastases in lymph nodes nor do many groups have immediate subspecialty expertise when the need arises.  

To all of the digital pathology technology providers we say that while we don't agree with the FDA requirement for PMA for your devices and software, we are ready to assist with the appropriate submissions and studies for what necessary clearance for us to provide the highest level of care possible to our patients with the help of your innovations to find solutions for everyday needs not unique to our group or laboratory.  Validated systems that can provide safe and reliable H&E reads will provide countless opportunities and together pathologists and technology providers can succeed.

Sincerely yours,

Pathologists for Digital Pathology 

 

 

 

 

 

 

 

Recent review article published on current state of whole slide imaging in pathology

August 24, 2011

A group of us recently summarized our thoughts from respective talks presented at the College of American Pathologists Companion Society meeting at this years' United States and Canadian Academy of Pathology.

I previously summarized who spoke at the actual meeting (see: Thoughts on CAP Companion Society Meeting at USCAP 2011).  

The publication is avaialble free of charge from the Journal of Pathology Informatics (see links) or you can download the PDF here.

Review of the current state of whole slide imaging in pathology

Liron Pantanowitz1Paul N Valenstein2Andrew J Evans3Keith J Kaplan4John D Pfeifer5David C Wilbur6Laura C Collins7Terence J Colgan8
1 Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
2 Department of Pathology, St. Joseph Mercy Hospital, Ann Arbor, MI, USA
3 Department of Pathology, (UHN) Toronto General Hospital, Toronto, ON, Canada
4 Carolinas Pathology Group, Charlotte, NC, USA
5 Department of Pathology, Washington University School of Medicine, Saint Louis, MO, USA
6 Department of Pathology, Massachusetts General Hospital, Boston, MA, USA
7 Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA
8 Department of Laboratory Medicine and Pathology, Mt. Sinai Hospital, Toronto, ON, Canada

 

    

Correspondence Address:
Liron Pantanowitz
Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA 
USA

© 2011 Pantanowitz et al; This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

DOI: 10.4103/2153-3539.83746

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   Abstract    

Whole slide imaging (WSI), or "virtual" microscopy, involves the scanning (digitization) of glass slides to produce "digital slides". WSI has been advocated for diagnostic, educational and research purposes. When used for remote frozen section diagnosis, WSI requires a thorough implementation period coupled with trained support personnel. Adoption of WSI for rendering pathologic diagnoses on a routine basis has been shown to be successful in only a few "niche" applications. Wider adoption will most likely require full integration with the laboratory information system, continuous automated scanning, high-bandwidth connectivity, massive storage capacity, and more intuitive user interfaces. Nevertheless, WSI has been reported to enhance specific pathology practices, such as scanning slides received in consultation or of legal cases, of slides to be used for patient care conferences, for quality assurance purposes, to retain records of slides to be sent out or destroyed by ancillary testing, and for performing digital image analysis. In addition to technical issues, regulatory and validation requirements related to WSI have yet to be adequately addressed. Although limited validation studies have been published using WSI there are currently no standard guidelines for validating WSI for diagnostic use in the clinical laboratory. This review addresses the current status of WSI in pathology related to regulation and validation, the provision of remote and routine pathologic diagnoses, educational uses, implementation issues, and the cost-benefit analysis of adopting WSI in routine clinical practice.

Keywords: Consultation, diagnosis, digital, education, frozen section, imaging, informatics, telepathology, validation, virtual microscopy, whole slide imaging

How to cite this article:
Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol Inform 2011;2:36

How to cite this URL:
Pantanowitz L, Valenstein PN, Evans AJ, Kaplan KJ, Pfeifer JD, Wilbur DC, Collins LC, Colgan TJ. Review of the current state of whole slide imaging in pathology. J Pathol Inform [serial online] 2011 [cited 2011 Aug 23];2:36. Available from: http://www.jpathinformatics.org/text.asp?2011/2/1/36/83746

 

Blood Test For Baby’s Gender Accurate, Potentially Controversial

August 11, 2011

On its front page, the New York Times (8/10, A1, Belluck, Subscription Publication) reports that according to a study published in the Journal of the American Medical Association, "a simple blood test that can determine a baby's sex as early as seven weeks into pregnancy is highly accurate if used correctly." Experts predict that "parents concerned about gender-linked diseases, those who are merely curious, and people considering the more ethically controversial step of selecting the sex of their children" are all likely to utilize this technology. The Times says similar tests have previously been commercially available but were often inaccurate. In response to concerns of gender selection, some companies require waivers from customers saying they will not use the test for that purpose.

USA Today (8/10, Szabo) reports, "The technology works by detecting 'cell-free fetal DNA,' or DNA from the fetus, which floats freely in a pregnant woman's blood." USA Today also notes specific concerns about possible misuse of the technology, citing a study in The Lancet estimating that "between 4.2 million and 12.1 million female fetuses were 'selectively' aborted in India from 1980 to 2010, a practice that is noticeably skewing the ratio of boys and girls in that country."

The AP (8/10, Tanner) specifies that the procedure tested in this study uses a PCR test for Y chromosome DNA to tell whether the fetus is biologically male or female. AP notes that testing was performed in research settings, while "tests that companies sell directly to consumers were not examined in the analysis." Researchers stated that "blood tests like those studied could be a breakthrough for women at risk of having babies with certain diseases, who could avoid invasive procedures if they learned their fetus was a gender not affected by those illnesses."

The Los Angeles Times (8/9, Khan) "Booster Shots" blog reported, "The researchers found that tests…are about 95% to 99% accurate, depending on several factors. They can be used well before ultrasound…and aren't invasive, unlike amniocentesis, which carries a small but real risk of miscarriage." However, science writer Karen Kaplan warns that "There's a whole industry of questionable genetic tests put out by 'entrepreneurs' that promise to tell parents-to-be practically anything about their future children, from ethnic heritage to most viable future sports activities."

The Wall Street Journal (8/9, Hobson, Subscription Publication) "Health Blog" noted that some diseases, such as congenital adrenal hyperplasia, require corticosteroid treatment of the mother throughout her pregnancy if the fetus is female. Therefore, the test would find that a woman carrying a female child with this condition should be treated, while a woman carrying a male child with the condition could avoid such treatment.

According to the Boston Globe (8/9, Kotz) "Daily Dose" blog, currently available tests in the US are unregulated by the US Food and Drug Administration. Notably, "Several years ago, Lowell-based Acu-Gen Laboratories promised that its Baby Gender Mentor blood test was '99.9 percent accurate' in detecting a fetus's sex at five weeks and offered refunds to anyone who received wrong results. The company was forced into bankruptcy in 2009 after hundreds of women with false results filed class action lawsuits after they said they weren't given any refunds." The researchers who published this study said the Acu-Gen test detected the "Y chromosome only 41 percent of the time." 

In a commentary for MSNBC (8/9), University of Pennsylvania Center for Bioethics director Arthur Caplan wrote that outside of testing for sex-linked genetic diseases, "everything about the early testing of fetal genes for sex identification spells ethical trouble." Caplan predicted these tests will soon be used for gender-selective abortion, paternity testing, and whether "your 7-week-old fetus is prone to early onset breast, colon or ovarian cancer, Down syndrome, cystic fibrosis, sickle cell disease, dwarfism, deafness, Alzheimer's." Caplan argued this test "promises to soon be a very morally contentious technology." 

MedPage Today (8/9, Fiore) reported, "In a review and meta-analysis, detection of Y-chromosome sequences had a sensitivity of about 95% and a specificity of nearly 99%, Stephanie Devaney, PhD, of the National Institutes of Health in Bethesda, Md., and colleagues reported." Researchers stated "that a disadvantage of fetal DNA blood testing is the need to validate female sex, because the test looks for male, or Y-chromosome, DNA." MedPage Today also noted that the National Human Genome Research Institute funded the study.

Travel Awards Available for the Pathology Informatics 2011 Conference

July 15, 2011

The Association for Pathology Informatics is awarding a limited number of stipends of $1,500 to attend the Pathology Informatics 2011 Conference at the Pittsburgh Wyndham Grand hotel in Pittsburgh. The conference will take place on October 4-7, 2011. Awardees must be residents, post-doctoral students, or fellows in accredited teaching programs. This is the premier pathology informatics conference in the country with three workshops, three discipline tracks, multiple keynote plenary lectures, 44 participating faculty members, and more than 40 exhibitors. Last year's PI-2010 presentation marked the first of these events. The conference represents a merger of two long-standing pathology informatics meetings, APIII and Lab InfoTech Summit. The application deadline for awards is August 1, 201, so those interested should apply soon. Applicants must be residents or fellows in a training program accredited by the Council for Graduate Medical Education (ACGME). More details can be obtained at the conference web site including details about how to apply.

via labsoftnews.typepad.com

Graduating Physicians Opt for Jobs in Hospital-Owned Practices over Private Practices

May 9, 2011

Courtesy of Dark Daily

Trend could prove unfavorable to independent clinical laboratory companies

More physicians now join hospital-owned practices than any other type of practice. That’s one conclusion reported in a survey conducted by the Medical Group Management Association (MGMA). This is a trend that may have negative implications for independent clinical laboratory companies and pathology groups that provide medical laboratory testing to office-based physicians. 

In the MGMA survey, higher compensation packages offered by hospital-owned practices were cited as one reason why growing numbers of physicians choose a hospital-owned practice. The survey also determined that physicians believe they will have a better chance for reimbursements in hospital-owned practice settings, compared to other practice models. 

Meanwhile, first-year compensation packages continue to show wide variation for single-specialty versus multi-specialty practices, as well as between specialists and primary care physicians. It is a bothersome trend, since the proportion of graduating physicians selecting primary care has declined in each year of the past decade.

Full story

President Bill Clinton to Keynote 2011 ASCP Annual Meeting

March 17, 2011

CHICAGO – March 14, 2011 – President Bill Clinton, the Founder of the William J. Clinton Foundation and the 42nd President of the United States and a champion for global health, will be the keynote speaker at the 2011 American Society for Clinical Pathology (ASCP) Annual Meeting on Wednesday, Oct. 19, in Las Vegas.
His address, “Embracing Our Common Humanity,” will set the stage for a truly international conference, which is serving as host to the World Association of Pathology and Laboratory Medicine (WASPaLM) XXVI World Congress. “A Global View of Pathology and Laboratory Medicine” is the theme of ASCP’s signature event, Oct. 19-22 at the Venetian-Palazzo Resort Hotel Casinos.

“President Clinton is the world’s leading advocate for global health initiatives, and ASCP has a corps of dedicated volunteers working to improve laboratory services in resource-limited countries,” said ASCP President John E. Tomaszewski, MD, FASCP.

After his two terms as U.S. President from 1993 to 2001, President Clinton established the William J. Clinton Foundation to strengthen the capacity of people around the world to meet the challenges of global interdependence.  The Clinton Health Access Initiative (CHAI), formerly the Clinton HIV/AIDS Initiative, works to strengthen integrated health systems in the developing world and expand access to care and treatment for HIV/AIDS, malaria and tuberculosis.

ASCP’s Institute for Global Outreach works to improve global health by identifying and implementing innovative methods and partnerships that improve laboratory practice.

ASCP Executive Vice President E. Blair Holladay, PhD, SCT(ASCP)CM, said ASCP and WASPaLM are partnering this year to build stronger bridges between national and international societies for all members of the laboratory team. WASPaLM represents 45 societies of pathologists and laboratory professionals in 34 countries.
Registration for the 2011 ASCP Annual Meeting is now open.

www.ascp.org/2011AnnualMeeting/register.html

CMS to Rescind Physician Signature Requirement; CMS’ Change in Policy Illustrates the Power of Grassroots Advocacy

February 13, 2011

The American Society for Clinical Pathology (ASCP) is pleased to announce that it has learned that the Centers for Medicare and Medicaid Services (CMS) is planning to rescind its recent rule requiring a physician's signature on requisitions for laboratory tests reimbursed under the Medicare clinical laboratory fee schedule. The CMS rule proved very controversial and prompted not only the collective opposition of the entire laboratory coalition but also the American Medical Association and a number of other medical specialty societies.

ASCP, in tandem with its partners in the Clinical Laboratory Coalition, mounted an aggressive campaign to protest the proposal. ASCP launched two separate advocacy campaigns on the rule. The first campaign let CMS know directly the concerns of ASCP members, while the second campaign was intended to encourage members of Congress to contact CMS in opposition to the rule. In total, ASCP members wrote more than 2,000 letters in opposition to the rule. CMS received a loud and clear message from Congress today as the agency received a letter from 89 members of the U.S. House of Representatives and another letter from more than 30 U.S. Senators.

In announcing the agency's intent to withdraw the rule, it was mentioned that the agency would officially withdraw the rule well in advance of the April 1 date that the rule was supposed to go into effect. For more information on the rule, click here.

 


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