Message from the ASC President – Eva M. Wojcik, MD

It seems like it was just yesterday that we met in Chicago for our Annual Scientific

Eva M. Wojcik, MD, MIAC

Eva M. Wojcik, MD, MIAC

Meeting, and it’s already February. Right after the Meeting the holiday season arrived with parties, potlucks, preparations, gift wrapping and everywhere work/projects were put slightly aside. In January, we all had to pay for the holiday season and catch up with our work. Although it seems illogical to do this, we all know we will repeat this cycle this year and all the years to come!

However, this does not mean that no work has been done at ASC. Holidays or no holidays, the regular Society’s activities are taking place. Since the last Annual Scientific Meeting, over 30 calls/committee meetings took place! I am in constant contact with our ASC National Office, having scheduled weekly calls with Beth Jenkins, our Executive Director. To ensure a smooth transition of the presidency, the Officers are equally involved. We have monthly calls to discuss and review all pertinent issues and events. For many committees, this has almost been the busiest time of the year. The best example is the Scientific Program Committee that has already met formally or informally five times.

In Chicago, I promised to “keep you in the loop.” We will use this blog to be a platform informing you throughout the year about the Society’s activities. Starting next month, we will have regular updates from main committees with the first report from the Scientific Program Committee. As you may remember, each committee was charged with identifying a specific project that the Committee will be concentrating on this year. Many exciting initiatives have been identified and a steady progress is being achieved and will be shared with the entire membership on this platform. Also, I asked all committee members to provide questions for our very successful Progressive Evaluation of Competency (PEC) program. I am happy to report that over 160 new questions have been submitted to the PEC Committee for their review and approval.

I am also happy to report the ASC-ASCP Workgroup’s flagship project – Advanced Cytopathology Education (ACE) course preparation is practically finalized. The program is exciting and will encourage participation of many local cytotechnologists, pathologists, residents, fellows and students. The two-day cytopathology education program speakers will be almost all of our well-known prominent ASC Executive Board members making the meeting more attractive.

Coming back to our Annual Scientific Meeting in New Orleans, a number of new exciting initiatives will take place. In the next blog, the Chair of the Scientific Program Committee, Dr. Kristin Atkins, will share the Committee’s plans or New Orleans to motivate you to attend this event.  One of my Presidency’s initiative and theme is concentrating on “What is Your Value?” The 2016 Annual Scientific Meeting will be a platform for you to share your story, your data and your research. All of us have a “story”: How did we improve our processes? How did we become more visible in our department, institution or hospital? How does our presence and our skills directly improve patient outcome? So, come to New Orleans and TELL US YOUR STORY!

Please, stay tuned for more information.

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Message from Dr. Eva Wocjik, the ASC President

It is my greatest honor to serve you and the Society as your President, and I am looking

Eva M. Wojcik, MD, MIAC  Loyola University Medical Center Maywood, Illinois

Eva M. Wojcik, MD, MIAC

forward to working with and for you in the upcoming year. The customary objective of the President’s Message is to describe the future and what is ahead for the Society. Of course, I do not hold a crystal ball in my hands and cannot predict all potential unexpected events; however, I am certain that whatever happens, we will be successful in this coming year simply because we all hold our future in our hands.

As Abraham Lincoln once said: “The best way to predict the future is to create it,” and that is what we’ll do this year – we will create our future! We also have to keep in mind what Theodore Roosevelt did say: “The more you know about the past, the better prepared you are for the future.” Therefore, what we do know:

  • We have a strong Foundation – Cytology is relevant today more then ever. We are the best suited to provide a diagnosis on minimal amount of material that is obtained in a least traumatic way.
  • We have a proven record – When we say “We Save Lives One Cell at a Time,” we mean it. This is not an empty slogan – that is what we do, every single day!
  • Our Membership is strong, dependable and growing.
  • We have a solid structure – our Bylaws are effective and our National Office is composed of people who devote their careers and lives to this Society.
  • We are financially stable due to the prudent stewardship of previous ASC Presidents and the Executive Board.
  • We are flexible and we can adapt – our Strategic Plan is being reviewed constantly and adjusted as needed to address new, unpredicted changes in our health care environment.
  • We are very proud of and committed to the Society – after all, the ASC is OUR Society.

Success Starts with Opportunity

The ASC has been MY Society for a quarter of the century. Exactly 25 years ago, I attended my first ASC Annual Scientific Meeting in Washington, DC. That was one of the proudest moments in my life. Just a few years earlier, I arrived in this country not speaking any English and then at this national meeting, I am a senior pathology resident presenting two posters! From day one, the ASC gave me an opportunity and that continued through all those years. Considering that “success starts with opportunity,” when it was time to work on committee appointments, I have followed these guiding principles: opportunity for everyone, inclusion, transparency, rules, and accountability. From the beginning my goal was to include all members who have volunteered through the Call for Volunteers. In order to achieve this, in most cases no multiple appointments were made and Executive Board members were not appointed to serve on other committees this year; however, Board members will have advisory roles as liaisons between the Board and their assigned committees.

I am very happy to report that whoever volunteered, 100% became a member of a committee! We made 95 new appointments out of 246 committee members (38.6%). Each committee has defined responsibilities, initiatives and charges according to the updated Strategic Plan. In addition, I asked each committee to identify a specific, measurable goal to be completed by the end of one year. Each project has to follow the “3T” rules: what is the final measurable Target, what is the Timeline and what is the Team responsible for individual milestones? I plan to write a Presidential Blog to keep you informed on the progress of our committees’ work.

In addition, each member of a committee will be expected to provide at least one question for the Progressive Evaluation of Competency (PEC) question pool. Of course, those members who have any conflicts of interest would be exempt. Also, each member will serve as an ad hoc reviewer for our journal, Journal of the American Society of Cytopathology (JASC). Therefore, there will be plenty of opportunities for everyone to serve our Society.

Theme – What’s your value?

I am not sure if you know, but once you are the President-Elect, everyone will ask you: What will be the theme for your presidency? For many months, I have been thinking, what will be my theme, what will be my theme? Considering all the changes around us while we are entering into a value based health care, the logical question coming to our minds is – what is our value and, the most important one, how to measure it? Currently, we are living in the “world of dashboarding.” Everything is measured and tracked, therefore, how to dashboard our value? How to translate our values into numbers? Many may see this as a challenge, but for me, I see an opportunity, opportunity for research.

So, I challenge you – provide basis, evidence for our value. Think outside the box; think about downstream effects of your contributions. For example, how your timely diagnosis affected the length of stay (LOS) or patient satisfaction. Use any opportunity to present your data locally, show your colleagues how your work positively influences patients’ outcome. Most importantly, we have to publish these data. We have to remember, published evidence-based data is the basis for any new guidelines, regulations, reimbursement, codes, etc. Therefore, let’s gather in New Orleans at our next Annual Scientific Meeting and share all these data with each other. I will work with the Scientific Program Committee to ensure a venue to exchange our experiences.

But that is not enough……remember, our future is in our hands; therefore, we have to become visible and become advocates for our profession, for ourselves. It is time to learn how to be comfortable being uncomfortable. It is time to get out of our “basements,” from behind our familiar, comfortable microscopes and tell everyone who we are and what our value is. We have to meet patients, most importantly talk to them, tell them that based on our diagnosis they can be treated, they can be healed.

We also have to remember, we are part of the Pathology family and we share visions and goals of our sister societies, and we also face common challenges. The scope of practice changes will affect all of us regardless of specialty or the level of training. What keeps us apart from others is that indeed we are taking the future in our hands and working on defining and discovering new career pathways. We are putting our words into action and we see the first results of our inter-societies collaborations. The best example is the work of the ASC/ASCP Workgroup, “Focusing on Emerging Role of Cytotechnology” and their very successful launch of an Advanced Cytopathology Education (ACE). The next ACE will take place on May 21-22, 2016 at the Loyola University Medical Center in Maywood, Illinois, a western suburb of Chicago.

New Strategic Plan

We have been very proud to follow our robust and visionary plan initiated in 2012 by our previous President, Dr. Lydia Howell and recently extensively updated under the leadership of Dr. Ritu Nayar and Dr. Michael Henry. However, it is time to take a more critical look and, most importantly, evaluate our current Strategic Plan’s relevance in the context of incoming changes in the health care environment. This could not be more relevant today, particularly in the context of a recently released Institute of Medicine (IOM) report on “Improving Diagnosis in Health Care.” The report was released on the 15th anniversary of the first IOM report, “To Err is Human” that transformed the way we think about the patient safety. The current report concentrates on diagnostic errors, and it proposes aspirational goals of improving the diagnostic process and gives concrete recommendations for major systems and process changes. Our goal will be to keep those recommendations as guiding principles and align our new Strategic Plan accordingly. This work will be lead by Dr. Michael Cohen, Professor and Vice Chair at the University of Utah who was one of 21 members of the IOM committee that created that report. The progress of this work will be presented on this forum.

WATTBAC – What A Time To Be A Cytologist!

In summary, exciting times and projects are ahead of us. We are extremely well positioned with our natural and historical team approach to patient care and, most importantly, with our proactive approach to our future. This is the time of opportunities for our profession and our Society!

Message from the ASC President

What an honor it is to have been elected to the presidency of the American Society of Michael Henry - ASC PresidentCytopathology. This organization has been central in my professional life for almost 30 years. Many of my friends and mentors have been Presidents of the ASC, and I feel extremely privileged to join their ranks. The ASC has grown and changed significantly since I first joined right out of residency. Over the years these changes have strengthened the organization and put it on a path, which should lead to continued success. As an example, it is interesting that my presidency came from changes made many years ago when we moved to a competitive election for officers, which allowed the members to select from at least two nominees rather than a single candidate. While I did not win the first time I was nominated, I became part of a growing group of well-qualified members with experience and expertise who could be tapped by the Nominating Committee for possible election. Overall, these electoral changes have resulted in a stronger electoral process and demonstrated the wisdom of the Officers and Members who made the changes.

Change and innovation are integral to the message I want to convey in this letter to the ASC membership. All of the messages written by the last several Presidents have talked about the changes that medicine is undergoing and how they may affect the field of cytology and the ASC. We live in an exciting and sometimes uncertain time of growth, new knowledge and innovative techniques, many of which will transform the way we practice medicine. Transformational forces come not only from the scientific side but also from the regulatory and business side of medicine. We are moving away from private practice – fee for service medicine – and no one is sure where this will lead. It is certain, however, that for the foreseeable future cytology will be a valuable part of diagnostic and therapeutic medicine.

The field of cytopathology is unique. In an age when most of pathology is subspecializing into smaller and smaller areas of expertise, cytology remains a generalist field. Cytologic specimens are derived from the entire gamut of tissue and disease. The range of specimens that we utilize is vast, derived from fine needle aspiration, fluids, brushes, washes, core biopsies or any other technique, which yields small tissue samples. To be a good cytopathologist requires knowledge that spans across all of the anatomic pathology specialties and even many of the clinical areas. This generalist background is one of the strengths of cytopathology, which will keep us relevant far into the future. But at the same time, we will need to work to keep this relevance and not let some of these collection techniques become the provenance of subspecialists.

Collaborative efforts between the ASC and other pathology and medical organizations will be necessary to move our agenda forward on a national basis. Under the leadership of our most recent Past Presidents we now have working arrangements or memorandums of understanding with many of the national pathology and other medical organizations. We will continue to make overtures with these and other organizations to collaborate in areas where it makes sense. We are the repository of vast experience in cytologic methods, diagnostic techniques and education. The ASC must be involved with any organization that is making decisions or recommendations where cytology is concerned.

In 2012, under the leadership of Dr. Lydia Powell the ASC Executive Board (EB) developed a new Strategic Plan, which was implemented along with an updated vision and mission statement. This Strategic Plan contained specific goals and benchmarks as well as strategies to accomplish them. Most recently, at the last Board Meeting the EB reviewed the plan to see how well we have accomplished these goals and to write new ones as appropriate. My next President’s Blog will detail the results of this review.

Finally, there are a couple issues that are foremost in my mind and that will need to be addressed in the near future. These are the future role of the cytotechnologist in the laboratory and the role of cytopathology in the field of molecular testing.

The Future Cytotechnologist

We know that primary GYN screening using Pap tests will continue to decrease. During the past year the long anticipated clearance for primary HPV testing with cytology as the reflex test was approved by the FDA. While this is concerning to many in the field, there has been no rush to start this testing on the part of primary care clinicians. As with most new techniques, this type of testing will slowly work its way into the field; and it is still unknown how quickly it will be accepted.

We have known this was coming for some time. The ASC and other organizations are already looking at how the field of cytotechnology will and should evolve as Pap screening becomes a smaller portion of the work cytotechnologists perform. At this year’s Annual Scientific Meeting, the CPRC presented the results of meetings to develop a professional scope of practice for a proposed mid-level pathology practitioner for the field of cytopathology. Over the next year we will work with the CPRC, ASCP, CAP, and ASCT on this concept, especially directed to determining the need for this type of practitioner through a detailed practice analysis. In the meantime, we will also look at how to help current cytotechnologists transition to new technologies from their primary screening roles.

While we still do not have a clear idea of the cytology workforce over the next several years there are worries that the cytotechnologists are aging and that given the small overall numbers in the profession a workforce deficiency is certainly a possibility. There is already a definite shortage of laboratory professionals in areas such as histotechnology and molecular biology and with the steadily decreasing number of cytotechnology schools, now down to only 25 active programs, cytotechnology may also be facing a similar shortage. The recent partnership with the ASCP, ASCT and CAP to provide membership to the CPRC as well as the development of the Cytology Education Learning Lab (CELL) will help to develop the new curriculums that will be needed to provide the innovative education for our cytotechnology students.

I would like to finish this section by talking about the role the Mayo Clinic has taken in redefining the practice of cytotechnology. Over the past 15 years, we have pioneered the use of cytotechnologists to perform many somewhat non-traditional tasks. We have leveraged the cytotechnologist morphology training to utilize them in the screening of FISH cases on cytologic preparations, digital analysis of breast prognostic markers on tissue, analysis of circulating tumor cells and most recently initial review of tissue for molecular studies. This is in addition to the more traditional roles of on-site evaluation of FNA specimens and screening of non-GYN cytology. We have moved away from GYN screening as the primary CT role as our numbers of GYN Pap tests have decreased. Currently, Pap screening involves less than 10% of our technologist workload but we have actually increased the number of cytotechnologists needed to support the laboratory’s needs. We have found that all of this has made economic sense for our laboratory as it has freed up the pathologists to do their job more efficiently. Will this work in other settings? I don’t know the answer to that, but I do believe that as the business of pathology changes, this type of innovative use of qualified cytotechnologists will become more common.

Cytology and Molecular Pathology

We are currently entering a new era of medicine based on molecular techniques used for diagnosis, therapy and the monitoring of treatment response and disease progression. As I mentioned above, the field of cytopathology is unique in the breadth of specimens that we handle and utilize. Many of these specimens can and are being used for molecular testing of many types. This past year the ASC worked closely with the Papanicolaou Society of Cytopathology (PSC) to develop a joint position statement on the use of molecular testing on cytologic specimens. This position statement was approved by the ASC Executive Board at the Annual Scientific Meeting in Dallas. Over the next year the two organizations are also writing a white paper on molecular testing on cytologic specimens that will flesh out the details on many of these techniques and how they can be applied to our practice.

It is obvious that multidisciplinary collaboration will be needed in the effective utilization of these molecular techniques in cytologic specimens. Many molecular tests need to be performed in specialized laboratories and the cytopathologist will be the intermediary between the clinician collecting the sample and the performing laboratory. In those instances cytopathologists and cytotechnologists are well placed to work with clinicians to determine the on-site adequacy of specimens and determine the appropriate triage for the most effective use of small samples. Other molecular tests such as FISH analysis can be performed directly on cytologic preparations such as is currently done for urinary tract cytology and biliary or esophageal brushings. In my opinion, these samples are best interpreted by cytotechnologists trained in FISH techniques. Their morphologic experience in interpreting cytologic preparations makes them the obvious choice to select the appropriate cells for FISH analysis on smears or liquid based preparations.

There are more challenges because of the broad gamut of our tissue samples. We not only have tissue fixed in formalin and paraffin embedded (FFPE) but have samples that are fixed in alcohol and smeared or prepped as thin layer samples. As noted in the position statement: “Given the versatility of cytopreparatory techniques, the development and careful validation of molecular assays for these platforms is important.” The next several years will be a time of growth and greater understanding of which molecular techniques have clinical importance and how we as cytopathologists and cytotechnologists will fit into this burgeoning field. It will be vitally important that the ASC takes a primary role making sure our members are ready to move into the molecular era.

In summary, these are fast changing and exciting times full of challenges to our membership. I will be working with the Officers, Executive Board and the Committees to ensure that the ASC will continue to move in a positive direction to meet these challenges. My challenge to the ASC Members, Officers and Committees is to take the ASC vision to heart and look for innovative ways to grow/move the ASC forward in these turbulent times. Let me know about your ideas. While the Officers, Executive Board and Committee leaders have a wealth of knowledge and expertise, we don’t have all of the answers or specific ideas for projects, educational tools or new ways of doing things. Your contributions can be large or small; it doesn’t matter as long as you are an active participant in the organization. Volunteer – we are always looking for new members to add to the committees or other activities but we can’t use you unless we know who you are. Forms for volunteers are located on the ASC Web site. You are never too young or inexperienced so don’t be shy. We all started somewhere and who knows, someday you may be writing this message yourself.

Michael R. Henry, MD

ASC: The 2014 Year In Review

Ritu Nayar, MD, Immediate Past PresidentRitu 2013
Chicago, Illinois

It has been my honor to have served as the ASC President in 2013-2014. I would like to take this opportunity to review where the ASC is today, and what we accomplished together in the past year.

In 2012-13, the ASC Executive Board, under the leadership of Drs. Lydia Howell and Andrew Renshaw, defined an updated Strategic Plan that identified our:

  • ASC Vision Statement: Saving Lives One Cell at a Time through Innovation, Teamwork, Education, Advocacy;
  • ASC Mission Statement: ASC promotes education, innovation, advocacy and professional ethics by the cytopathology team to achieve the best healthcare for individuals and communities worldwide;
  • Strategic Goals (chosen to work toward our mission and vision): The ASC identified 7 major strategic goals (membership, education, advocacy, organizational, quality and research) and a number of strategies to meet these goals; and
  • Volunteers: Our member volunteers who serve on ASC committees and as representatives to other organizations are key in identifying ways to accomplish these strategic goals.

Last year when I addressed the Society as incoming President, I talked about the “State of the Nation’s Health Care” as it pertains to our profession and its physician and cytotechnologist members.1 The basic challenges we are facing in the rapidly evolving healthcare arena are not unique to pathology or cytopathology, namely an evolving health care delivery system with rapidly emerging theranostics, along with workforce shortages and economic pressures. I based my priorities for the past year on the evolving health care dynamics that affect our specialty/ practitioners and the support of our ASC member needs as assessed by surveys and personal communications. In 2014, I chose to concentrate more specifically on practice changes relevant to cytopathology and the 3 strategic goals of membership, education and advocacy.

I am a firm believer in teamwork. With professional organizations, there is more that unites than divides us – we are all working towards bettering our profession, raising the standard of practice and improving patient care. Over the past year we have formalized several new collaborations and continue to foster prior ones, in order to ensure that ASC participates as a partner in organized leadership, and can proactively associate with the right efforts to advocate for our profession.

  • Association of Pathology Chairs (APC): In December 2013, the ASC joined the Pathology Collaborative Roundtable implemented by APC with the aim of facilitating networking and communication and promoting synergistic planning about issues and joint initiatives of high priority to our profession.
  • College of American Pathologists (CAP): A Memorandum of Understanding was signed between ASC and CAP in April 20142
  • American Board of Pathology (ABP): In August 2014, the ASC was approved as a cooperating society of the ABP, a member of the American Board of Medical Specialties.3
  • American Society of Clinical Pathology (ASCP). We continue to increase collaboration under the umbrella of the MOU signed with ASCP in 2012.4
  • Cytotechnology Programs Review Committee (CPRC) is a CAAHEP Committee on Accreditation for Cytotechnology training programs. In 2011, the ASC who sponsors the CPRC, welcomed ASCP, ASCT and CAP as co-sponsors; however ASC still remains the majority (50%) sponsor.
  • Cytopathology Education and Technology Consortium (CETC): The ASC collaborates with ASCP, American Society for Cytotechnology (ASCT), CAP, International Academy of Cytology (IAC), and the Papanicolaou Society of Cytopathology (PSC) on the CETC; ASC also provides the CETC’s administrative leadership support. The history of the CETC is rich and interesting; I refer you to the September 2013 issue of The ASC Bulletin to read about its accomplishments on behalf of cytopathology.
  • Other collaborative efforts have involved various other pathology and non-pathology organizations as detailed below.

PRACTICE CONSIDERATIONS

Cervical Cancer Screening
Since 2002, with increasing use of high risk HPV testing, we have seen shifts in cervical cancer screening and management guidelines, with movement from screening with cytology only to co-testing with cervical cytology + HPV and in April 2014, approval of HPV as a stand-alone option for screening. While all 3 strategies remain as current options for screening in the United States, the impact on cytopathology and cytotechnologists has been significant with respect to the volume of gynecologic cytology.

The ASC and its volunteers actively participated in the development of the 2012 ACS/ASCCP/ASCP screening guidelines. 5 In December 2013, the CETC published an updated HPV Test Utilization Statement in several journals. 6 At the March 2014 FDA hearing for pre-market approval of the Roche Cobas test for HPV Primary Screening, the ASC led the effort on behalf of the CETC to submit a written and verbal statement to the FDA advisory panel.7 The CETC raised concerns that included the use of laboratory-developed HPV tests, quality-control, specimen adequacy, and HPV-negative cancers. Our membership has been regularly kept informed about the laboratory considerations for HPV Primary screening via the President’s Blog 8 (LINK) and publications.9 At the ASC 2014 Annual Scientific Meeting, we organized a “Hot Topic” session entitled “Primary HPV Cervical Cancer Screening – Pros, Cons and Implications for Clinical Practice.”

Interim guidelines for HPV Primary screening in the United States, prepared by a task force appointed by the Society of Gynecologic Oncology (SGO) and the American Society of Colposcopy and Cervical Pathology (ASCCP), will be published in early 2015. 10 Drs. Diane Davey and Robert Goulart served as the joint ASC-ASCP-CAP representatives to this task force, and contributed the laboratory perspective for this guidance document. At this time it is not known when other professional societies, including the ACS and USPSTF, will issue updated guidelines for cervical cancer screening. Currently, cytology only testing, as well as co-testing, are being used variably in different age groups for cervical cancer screening. Any future adoption of primary HPV testing will most certainly require time and ongoing monitoring of clinician acceptance, patient compliance, in addition to cost-benefit and outcomes analysis.

Since mid-2006, the Advisory Committee on Immunization Practices (ACIP) has recommended routine vaccination of adolescent girls at ages 11 or 12 years with 3 doses of human papillomavirus (HPV) vaccine. The uptake has been low in the United States (only 37.6% adolescent females had received all 3 doses in 2013) compared to countries with organized screening programs. Vaccine cost/availability/ insurance coverage, patient /parental consent and social norms and values have all contributed to this.

In September 2014, the ASC released a new Cervical Cancer Screening Position Statement.11
The ASC and its membership are committed to supporting women’s health and working collaboratively with other pathology and clinical professionals to effectively prevent cervical cancer in the United States. The ASC supports innovations in technology and changes in testing and management based on scientific and clinically‐validated advancements. However, realizing that cervical cancer screening in the United States (a) remains opportunistic, with far from uniform test accessibility and patient compliance, and (b) 50% of cervical cancers diagnosed in the U.S are in women who were never screened, and an additional 10% of cancers occur among women not screened within the past five years, we believe that further improvement in cervical cancer prevention and mortality can only be obtained by screening everyone and HPV vaccination.

Ancillary/Molecular Testing
We have all witnessed the recent explosion of personalized medicine options that are becoming available in medical practice. As cytopathology practitioners, we are uniquely positioned as a crucial member of the multidisciplinary team charged with triaging patient cytologic samples for appropriate, and clinically relevant molecular diagnostic assays. It is essential that we engage relevant stakeholders in our respective institutions to allow for the judicious and effective integration of molecular ancillary testing with cytopathology specimen acquisition, processing, and analysis in order to ensure timely and appropriate patient management. The ultimate goal of these multidisciplinary efforts is to devise “best practice” approaches for cytologic specimen acquisition and processing.

In November 2013, I approached the Papanicolaou Society of Cytopathology (President, Dr. Zubair Baloch) to collaborate on “The Role of Molecular Testing in Cytology Specimens”. The appointed ASC-PSC Task Force (Chairs: Drs Michael Roh and Amy Clayton) formulated an ASC-PSC Joint Position Statement that was released on November 10, 2014.11 The group will continue to work on a “white paper” to provide guidance to practitioners dealing with FNA and small biopsy specimens for molecular testing.

In August 2014, in conjunction with the leadership of the Association for Molecular Pathology (AMP), I formally appointed an ASC-AMP liaison (Dr. Anna Berry) to coordinate efforts with respect to molecular testing on cytology and small biopsy specimens.

Needs Assessment – Data Collection
In 2014, the ASC Clinical Practice Committee (Chair, Dr. Christine Booth) was charged with surveying the membership on cellblock practices and assessing non-gynecologic practice patterns (done in conjunction with the ASCT). The latter will be available in a future issue of The ASC Bulletin for your review. Through our collaborations with ASCP and CAP, we are also planning collection and analysis of additional data relevant to our professions needs assessment.

Reporting Terminology
As anatomic pathologists and laboratorians, we serve as consultants to our clinical colleagues and patients and our pathology reports are the official basis of our communication. Therefore, it logically follows that our reports should clearly communicate the pathology findings in a predictable and reproducible manner so that patient management options can be correctly tailored by the clinician. This past year, the ASC has led the following two major terminology projects, both of which allow(ed) ample time for national and international public comments on proposed outlines.12

  • The Bethesda System for Reporting Cervical Cytology – ASC Bethesda 2014 Task Force
    The cervical cytology Bethesda System (TBS) terminology effort, initiated in 1988, led the way for standardized reporting in cytopathology. In the past decade, considerable experience has been gained with the use and impact of the Bethesda terminology for cervical cytology in clinical practice. Thus 2014 seemed to be the appropriate time for a review and update of the 2001 Bethesda System with incorporation of revisions and additional information into a third edition of the Bethesda Atlas. Since minimal changes were anticipated in terminology, there was no consensus meeting held in association with the 2014 update. Therefore I appointed a task force, chaired by Dr. David Wilbur, comprised of a relatively small group of cytopathologists, cytotechnologists and clinicians/epidemiologists in order to expeditiously accomplish this task. The atlas was completed and submitted to Springer in October 2014; publication is expected in spring of 2015. Another Bethesda Task Force, led by Drs. Daniel Kurtycz and Paul Staats has begun working on a companion web site for the updated (2014) Bethesda System for Reporting Cervical Cytology.
  • Urinary Cytopathology ASC/IAC Urine Cytology Terminology Task Force
    We know that pathologists actively and non-reproducibly use the terminology “suspicious,” “indeterminate” or “atypical,” which causes confusion for clinicians and patients. Despite two well established pathways and prognostic categories for urothelial carcinoma, the cytologic terminology for urinary cytology remains disparate and complex. Drs. Wojcik and Rosenthal took the initiative to streamline this and approached me and Dr. Vielh, President of the IAC, to have ASC/IAC co-sponsor an effort to develop a standardized terminology for reporting urinary cytology specimens, modeled after the cervical and thyroid Bethesda systems – The PARIS System. The group has been working actively within and outside the United States, and has presented the proposed terminology at a number of national and international conferences. A print atlas and corresponding web site are in development with publication expected in May 2016.

Practice Guidelines and Position Statement Updates
The ASC is the premier medical society dedicated to the practice of cytopathology, and as such its leadership recognizes the need for the ASC to take a position on issues of importance to the profession or the association and have policies, guidelines, position statements and recommendations for its members, other professionals and patients.

Over the past year, the ASC Guidelines & Position Statements Review Committee (Patricia Wasserman, MD, Chair) has diligently updated the Society’s Standard Operating Procedure for review of ASC Position Statements and Guidelines, created a “roadmap” to guide reviews, and worked with content experts on updating existing guidelines and formulating new position statements. All policies, guidelines and position statements are opened to the membership for a two week comment period before finalization and are then approved by the Executive Board before posting on the ASC Web site. The ASC has also decided to publish commentaries to accompany its position statements and guidelines.

The following new/updated position statements and guidelines have been approved and posted on line in 2014. 11

  1. Position Statement on Cervical Cancer Screening and Prevention
  2. Position Statement on Rapid On Site Evaluation (ROSE)
  3. Position Statement Regarding State Licensure for Cytotechnologists and Guidelines on State Licensure for Cytotechnologists
  4. ASC/PSC Joint Position Statement on the Use of Molecular Testing on Cytologic Specimens

A Commentary on Cervical Cancer Screening and Prevention was published in The ASC Bulletin, July 2014, and those on commentaries on ROSE and State Licensure for cytotechnologists will follow in our journal, JASC.

Legislative/Regulatory and Reimbursement Issues
We owe a great deal of thanks to the ASC Government Affairs and Economic Committee (GAEC) Chair and AMA Delegate (Dr. Margaret Havens Neal) and our representatives to the AMA RUC (Dr. Swati Mehrotra) and CPT (Dr. Carol Filomena) Committees. It was not until this year that I fully understood the immense time and effort that is spent participating in these committees on behalf of our specialty. I spoke about the process in greater detail in my August 2014 President’s Blog. To support these representatives, in March 2014, I appointed the new ASC AMA-CPT-RUC subcommittee comprised of the ASC officers, chair of our GAEC and the 3 AMA representatives.

In 2014 the ASC participated and represented cytopathology in conjunction with the CAP at the following AMA meetings.

  • AMA Pathology Section Council
    The ASC has a seat in the AMA and our delegate(s) participate in its Pathology Section Council. In 2013-14, a number of issues of importance to pathology were discussed and supported- Network Adequacy, Electronic Health Records-and Meaningful Use, Genetic Testing, Practice Costs across Sites of Service, Opposition to Insurance Company Policies that Interfere with Appropriate Outpatient Laboratory Services, Overregulation of Provider-Performed Microscopy Procedures for Ambulatory Health Care, Facilitating State Licensure for Telemedicine Services and revisions to the AMA Code of Medical Ethics .
  • The AMA Current Procedural Terminology (CPT) and Pathology Coding Caucus (PCC)
    One of the Advisory Committees’ primary objectives is to serve as a resource to the CPT Editorial Panel by giving advice on procedure coding and appropriate nomenclature as relevant to the member’s specialty. The Pathology Coding Caucus (PCC) is a partnership of the AMA and other pathology and laboratory groups, which develops consensus recommendations on proposed new and revised CPT codes prior to consideration by the AMA CPT Editorial Panel. ASC in collaboration with other pathology and laboratory groups contribute regularly to PCC deliberations as part of the work of the AMA CPT Advisory Committee. The majority of the discussions this year focused on Molecular Pathology codes.
    There are no new codes in the 2015 CPT Manual in the Cytopathology section.  The CPT 2015 will include HPV testing (87623, 87624, 87625) and revised immunohistochemistry codes (88342, 88341 and 88344).
  • The AMA/Specialty Society RVS Update Committee (RUC)
    The RUC’s mission is to make recommendations to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare Resource-Based Relative Value Scale. At the April RUC meeting 2 sets of cytology codes underwent review at the Practice Expense Subcommittee (88104-88106 and 88160-88162 family). The recommendations made by the ASC in conjunction with College of American Pathologists (CAP) were accepted with minor modifications by the RUC.
  • 2015 Physician Pay Schedule (PFS)
    On October 31, 2014, the 2015 Final Medicare Physician Fee Schedule was released.13 Several new policies in the 2015 Medicare rule were a direct result of professional society advocacy. Under CAP’s leadership, the ASC participated actively in the AMA, RUC and CPT process. Evaluation of specifics of the rule and development of appropriate action plans for pathology are ongoing. To address CMS concerns that immunohistochemistry codes were overvalued, review and refinement of the coding and reimbursement for immunohistochemistry codes has been a priority over the last few years and through efforts of multiple pathology organizations, CPT, and the RUC. For 2015 CMS has accepted those revisions, and abandoned use of the G codes that have been in effect for 2014. The revised codes will eliminate confusion between Medicare and non-Medicare payers, and allow for revaluation of the initial single antibody stain procedure as well as for each additional single antibody stain procedure when necessary. A separate code for multiplex procedures was also approved. In the Final Rule CMS “packaged” the technical components of roughly 200 physician services, including 30 pathology services into the hospital’s reimbursement for services provided in the hospital outpatient department (HOPPS) and in ambulatory surgical centers. Relevant to cytopathology are: 88305, 88173 88312, 88342, 88120/21, 88360/61.
  • Scope of Practice for Cytotechnologists
    The ASC has been working with ASCP to enhance the cytotechnologist’s scope of practice in California so that it parallels the scope of practice of cytotechnologists elsewhere in the United States, to revise the regulations for laboratory personnel, including the provisions related to the ability of cytotechnologists to perform molecular testing.

MEMBERSHIP

Workforce Consideration
Some areas of laboratory medicine have had a shortage of qualified non-physician personnel for the last several years as documented by professional societies and based on personal communications.14 Pathology and Laboratory Medicine also have an aging workforce, and recruitment, training and funding challenges. I participated in the Multisociety Pathology Workforce Summit organized by CAP, APC, ASCP, and USCAP in December 2013. The aim was to articulate the broad strokes of a statement of workforce needs in pathology and laboratory medicine suitable for sharing with health policy decision makers and key stakeholders. The focus will be on changes in training (and recruitment) of pathologists and laboratory professionals, how these shortages are likely to impact the workforce’s ability to fulfill its responsibilities to patients, and identifying shared opportunities to advance workforce issues affecting both pathology and laboratory professionals. Follow-up efforts from this group are in progress, and the ASC has participated in the following during 2014: (1) Task force to develop a pathology residency physician–scientist pathway, (2) Task force to address scope of practice issues in ACGME accredited fellowship training requirements and (3) Discussions on pathology extender workforce.

Cytotechnologists

Training Programs
The 2014 Cytotechnology Programs Review Committee (CPRC) Annual Report 15 indicates that currently in the United States we have 25 active (3 inactive) Cytotechnology programs. Of these 12 are Certificate‐only programs (a total of 21 programs offer a Certificate program), 9 are Degree‐only programs (4 offer a Masters level program) and 9 offer both Certificate and Degree programs. Data based on the last graduating class (2012‐2013) from 30 programs reported that of 262 student places available in accredited programs, only 168 (64.10%) were filled. Clearly we need to make the profession more attractive, modernize the curriculum and enable changes in the role(s) these graduates will take on when they enter the workforce.

The history of the ASC’s strategic discussions regarding workforce and preparedness for changes in the profession began in November 2001. Between 2001 and 2006, the ASC conducted surveys, gathered information, and explored ways to define the scope of practice of cytotechnologists in the context of workforce needs, and develop strategies for cytology educators to gear curricula to address those needs. A white paper entitled “Facing the Future of Cytopathology” that focused on discerning the future needs of our profession still remains a valuable source for future directions for the Cytotechnology professional.16

The CPRC, for the past several years, has championed the cause of developing an “advanced pathology laboratory professional” with core skills in cytopathology. A special CPRC retreat, held in February 2013 was successful in developing a revised curriculum to place Cytotechnology Programs on a more modern footing by including areas such as molecular diagnostics and digital pathology. The CPRC appointed a Resource subcommittee to undertake the task of providing Cytotechnology Programs with resources to meet the new Entry-level Competencies (ELC), which went into effect in July 2014. The CELL”- Cytology Education and Learning Lab was launched in February 2014 to support this endeavor17. The CPRC subcommittee and sponsors provided 120 resources for the CELL. As of the end of October 2014, CELL had 828 registrants of varying experience and areas of practice.

To continue implementation of the ELC, Phase II requires a change in the scope of practice of the traditional “cytology practitioner,” Thus in February 2014, the ASC and co-sponsors funded a second retreat for the CPRC to work on this. A “Mid‐level Pathology Practitioner” (MLPP) proposal was submitted by the CPRC to sponsors in March 2014. Responses were returned in September 2014. Committee members shared the MLPP proposal (along with sponsor feedback) with the cytopathology community for the first time in the CPRC Strategies in Cytotechnology Education session on November 14th at the ASC Annual Scientific Meeting in Dallas.

Current Cytotechnologist Roles in the Workforce
It appears that a large number of cytotechnologists in the workforce are still in traditional roles, with morphology comprising the majority of their workday, while others have taken on other “pathologist extender” tasks not previously performed by these laboratory professionals.18 Data from the ASCP Board of Certification (November 2014, personal communication) shows that there are 14,594 certified cytotechnologists of whom 650 hold an SCT certification. Of the 2,895 ASCP Molecular Biology (MB) certificates, 151 (5.2%) are held by cytotechnologists (CT or SCT). Besides the MB certification, the ASCP currently offers added qualification in immunohistochemistry (QIHC). We recognize that change for cytotechnologists is evident and inevitable, and we need to be at the forefront of this change to gather and triage data, create practice opportunities and develop applicable educational modules.

In order to support the growth, retention and placement of cytotechnologists who are already in practice, the ASC approached and began collaborations with the ASCP in June 2014 to form the “ASC/ASCP Workgroup: Focusing on Emerging Roles in Cytopathology.” This is a coordinated effort to (a) support identification of professional trends and offer meaningful resources to the cytopathology community, (b) focus on developing concrete goals towards addressing evolving practice changes while ensuring that education, practice and trending data support the Cytotechnology profession’s longevity and livelihood; and (c) support new roles for pathologists as cytotechnologists are increasingly expected to engage in the rapidly changing health care delivery system. The first year’s endeavors will focus on data collection and analysis, in support of our profession.

The ASC and ASCP also organized a panel presentation for the ASC Annual Scientific Meeting on “Emerging Roles for Cytotechnologists:Reallife Examples” in which five cytotechnologists provided empowering insights via presentations on what they have learned in their careers and what opportunities are available for cytotechnologists in transition. In preparation for this session, a survey was circulated that aimed to glean current insights and data from Cytotechnologists regarding goals and barriers in achieving professional goals; successes or inspirational experiences in expanding professional roles; characterization of future state of cytology professionals; skills that are being sought; and how national societies can contribute to goals. The session moderators (Ms. Amy Wendel Spiczka and Ms. Lynette Savaloja) received 350 responses!

The ASC hopes to enlighten and empower practicing cytotechnologists to pursue new opportunities and educational endeavors. Together with the ASCP, the ASC will be collecting trending data to support practice changes.

Pathologists

Educators
While there has been a projected decrease in the supply of pathologists,9 the demand end is yet to be determined with certainty, since the change in health care delivery systems, advances in technology and therapeutics as well as the political landscape are still in transition. They will all play a role in the need for the number and type of expertise required from medical professionals.

On July 1, 2014, core Anatomic and Clinical Pathology residency programs started to operate under the Next Accreditation System (NAS) from the Accreditation Council of Graduate Medical Education (ACGME). The NAS is designed to provide continuous accreditation data from residency programs to the ACGME each year, instead of three‐ to five‐year intervals between site visits in the old accreditation system. Cytopathology Fellowship Programs will start reporting Milestone data on fellows during in 2015. The ASC Cytopathology Program Directors Committee (CPDC), chaired by Dr. Deborah Chute, in an effort to assist Program Directors prepare for the new reporting requirements, addressed NAS, Milestones, developing a Clinical Competency Committee and assessment tools for Milestones in the 2013 and 2014 Strategies in Cytopathology Education Sessions.

The Committee has reenergized the ASC Program Directors Listserv with information exchange, and surveys. In October 2014, a survey was done to determine how Programs incorporate rapid on‐site evaluation (ROSE) in their Programs, and look for best practices and national trends. Results have been distributed back to the ASC Cytopathology Program Directors Listserv. The CPDC has also increased communications with members through The ASC Bulletin, the CPDC newsletter – Program Directors Communicator, and updates on the ASC Web site.

Pathology Residents and Fellows
The ASC is committed to providing input to the training and certification of pathology residents and fellows in the area of cytopathology. As of October 2014, the Society has 112 cytopathology fellows and 134 pathology resident members.

In August 2014, the ASC was approved as a cooperating society of the American Board of Pathology (ABP), which will allow input into the examination and certification process and input for ABP trustees. In September 2014, the ABP approved the Physician Scientist Research Pathway developed by APC with ASC participation (ASC representative, Marilyn Bui, MD). The ASC and PSC have joint representation on the Ad Hoc Fellowship Directors Committee developed by the Association of Pathology Chairs.

The ASC Progressive Competency Evaluation (PEC) exam has proved to be an extremely popular product for residents and fellows and it has been further strengthened in 2013-14 (PEC chair, Dr Claire Michael). Currently PEC has 234 participants – 118 fellows (75 programs) and 116 residents (13 programs). The PEC final examination performance has recently been reviewed and found to correlate positively with ABP certification.20

In October 2014, the CPDC released a new product on the ASC Web site- Problem‐based Learning Program for Cytopathology Education: seven cases that include Facilitator Notes, Learner Notes, an Assessment Quiz, and Objectives and References. Development of a Lab Management Curriculum and “Sound Bites” are in progress with four examples completed, and more in process.

State and Regional Organizations
Our members (and non-members) have often commented that networking and camaraderie are important factors that motivate them, in addition to the educational offerings to attend the ASC Annual Scientific Meeting. In today’s economy and staffing, not everyone can make it to the Meeting as often as they would like. Thus it was important for the ASC to help sustain local state society meetings. I charged the Executive Board Cytotechnologists to follow through with a needs assessment and develop a plan. They did a wonderful job in surveying and obtaining grant support for 4 societies per year to receive grants from the ASC Foundation to support regional meetings. We began to give these grants at our 2014 Annual Scientific Meeting.

Member Engagement
Our greatest asset is YOU – our members, who come together to support and volunteer to help us sustain the ASC and move us forward. As of October 2014, the ASC has 3038 members – 56.4% pathologists, and 43.6% cytotechnologists (Membership Committee Chair, Dr. Lourdes Ylagan). In 2013, when I appointed committees, 145/294 volunteer positions were new appointees and 85% of new volunteers were assigned to a committee.

The ASC has significantly expanded its communications with members during the past 2 years. While the listserv, The ASC Bulletin and emails are still utilized and popular, there has been good activity on social media (Face book, Twitter, YouTube and Instagram). In August 2014, we launched the ASC App, which provides members easier access to all ASC offerings. The “Member Communiqué,” “Member Spotlight” and CPDC Communicator are electronic communications to various groups in the membership. Since 2012, the ASC Presidents Blogs address various medical and non-medical topics relevant to our specialty and members. The ASC Web site is continually being improved for easy navigation and improved content – “Cytopathology News” and the calendar of events are updated regularly.

EDUCATION

Educational Offerings
The ASC offers a large variety of educational opportunities for the cytopathology community. (Table 1)
In July 2014, the Accreditation Council for Continuing Medical Education (ACCME) conducted a survey of ASC education programs and awarded full accreditation until 2018. The ABP recognizes the ASC as an accredited CME and SAM provider for Maintenance of Certification (MOC).

Table 1blog table

 

The ASC Scientific Program (Chair, Dr. Dina Mody) and Cyto-eConference (Chair, Dr. Güliz Barkan) Committees, overseen by the ASC Continuing Education Oversight Committee (Chair, Dr. Diane D Davey) must be congratulated for providing us a good balance of basics, research and new clinical applications in the ASC educational programming to keep us current. Note that the ASC provides free CME and SAM in the form of monthly e-Journal clubs and associated webinars as well as ASC Case Studies on the ASC Web site.

ASC Publications
In January 2014, the inaugural issue of the Society’s bimonthly journal- Journal of the American Society of Cytopathology (JASC) was published. The editorial team is led by Dr. Syed Ali (Editor in chief). The journal is receiving a steady supply of good articles and we encourage you to submit your research to JASC– Our Journal! In March 2014, a trainee award for the best trainee abstract at USCAP was initiated and will be presented annually. In October 2014, the publisher, Elsevier, released the JASC App for the iPhone and iPad. JASC is included as a member benefit for practicing Medical members and Voting Cytotechnologist members, and available at a discounted rate to other members.

In July 2014, the popular ASC Bulletin (Editor, Dr. Michael Thrall, incoming editor Ms. Brenda Sweeney) was merged with JASC, as one bi-monthly publication; however, the Bulletin remains freely available to all ASC members. This year the Web site Committee (Co-chairs –Drs. Brian Collins and Sara Monaco) presented a new, annual award for the best Case Study of the year at the Annual Scientific Meeting in Dallas.

Companion Meetings
The ASC’s Companion Meeting Committee (Chair, Dr. Eva Wojcik) coordinates educational sessions at a number of other pathology meetings, in coordination with both national and international professional organizations. In 2014, the ASC participated in USCAP, ASCP, and the European Congress of Cytology (ECC). For 2015, in addition to the above, we have planned companion sessions at CAP and also expanded our presence at clinical/non-pathology meetings including the American Association of Nurse Practitioner (AANP), American Urologic Association (AUA) and European Association of Urology (EAU).

ADVOCACY

The collaborations described above pertain to advocacy for our profession; however one of my goals in the past year was to increase advocacy efforts with the allied health care organizations and patient advocacy groups and help connect ASC members who wish to volunteer with educational, training and services required in low resource areas. This charge was assigned to the ASC Public Information and Advocacy Committee (Co-chairs: Drs. Rosemary Tambouret and Barbra Winkler).

In 2014:

  • A webpage has been created on the ASC Web site where volunteer opportunities & experiences are posted. I encourage you to read some of the stories our colleagues have shared and to tell us your own!
  • A list of ASC members who want to volunteer has been compiled.
  • ASC Advocacy Committee member, Britt-Marie Ljung, along with Drs. Ricardo Bardales and Ronald Balassanian led a mission to train of physicians on FNA technique for breast disease in Trujillo, Peru. This was sponsored by PATH, an organization associated with the Gates Foundation.
  • Tambouret, Benedict and Rollins will present a workshop on ultrasound guided FNA at the 2015 American Association of Nurse Practitioners (AANP) Meeting.
  • Tambouret and colleagues are working on the development of a universal curriculum for GYN cytology screening programs in low resource, underserved countries.

Other ASC Advocacy efforts include ASC Foundation Advocacy Grants and future collaborations with the CAP Foundation’s “See, Test and Treat” Program.

ASC Foundation Board
The primary function of the ASC Foundation is to fund the Society’s programs and expand its endowment to assure fiduciary responsibilities to the mission, membership and the public, as it insures the Society’s financial stability. In 2014, the Foundation Board under the leadership of Drs. Mary Schwartz and William Crabtree has collaboratively been designing a bold and innovative plan to ensure a strong future for the ASC Foundation. In April 2014, the Board had a retreat, during which the process of developing the framework for new initiatives and broadening the scope of fundraising activities, programs and services was started. Since then, the Foundation has developed a new logo and web site that gives the Foundation a separate but shared identity with ASC. Please refer to the September 2014 issue of The ASC Bulletin for more information of the Foundations contributions to the ASC mission and vision.

In summary, the Society has been prepared, present (at the right place, at the right time) and proactive in order to help shape the future of our profession.

I have been privileged to have been a member of this Society for the past 24 years, and I am honored to have served as its President. My professional life has been greatly enriched and influenced by the many teachers, mentors and colleagues I have met along the way, so many of whom are now close personal friends. I am grateful to the ASC Executive Board, the ASC staff and all the members and volunteers who worked closely with me to accomplish the past year’s goals. I encourage all of you to be volunteers and advocates and give back to the Society that has been pivotal in shaping our profession.  We are cytopathology professionals and the ASC is OUR Society!

REFERENCES

  1. Nayar, R. State of the Society. Journal of the American Society of Cytopathology, 2014; 3(1), pages I–IV.
  2. ASC-CAP MOU @http://www.cytopathology.org/cap-and-asc-collaborate-on-advancing-patient-care-through-cytopathology/.
  3. ASC and ABP@http://www.cytopathology.org/asc-abpath-collaboration-announcement/.
  4. ASC-ASCP MOU@ http://www.cytopathology.org/ascp-and-asc-sign-a-mou-to-partner/.
  5. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012;137: 516-542.
  6. Davey DD, Goulart R, Nayar R; Cytopathology Education and Technology Consortium (CETC). 2013 statement on human papillomavirus DNA test utilization. Am J Clin Pathol. 2014 May; 141(5):759.
  7. Cytopathology Education and Technology Consortium (CETC).Letter to the FDA regarding PMA hearing for HPV primary screening, February 27, 2014 [p. 179]. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Microbiology DevicesPanel/UCM393482.pdf. Accessed Nov 6, 2014.
  8. ASC Presidents Blog. Available @ https://ascpresidentsmessage.wordpress.com/2014/04/. Accessed November 10, 2014.
  9. Nayar R, Goulart R , Wasserman P, Davey D. Primary Human Papillomavirus Screening for Cervical Cancer in the United States – US Food and Drug Administration approval, clinical trials, and where we are today. Cancer Cytopath; 2014.
  10. Huh W, Ault K, Chelmow D, et al. Use of Primary High Risk Human Papillomavirus Testing for Cervical Cancer Screening: Interim Clinical Guidance. In press.
  11. American Society of Cytopathology Guidelines and Position Statements. Available at: http://www.cytopathology.org/asc-guidelines/ Accessed November 10,2014.
  12. https://paris.soc.wisc.edu/.
  13. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html?redirect=/physicianfeesched.
  14. ASCP 2013 Task Force on the Laboratory Professionals Workforce. Building a laboratory workforce to meet the future. Available at: http://www.ascp.org/PDF/Advocacy/ASCP-Task-Force-on-Lab-Pros.pdf. Accessed November 8, 2014.
  15. CPRC News @ http://www.caahep.org/Committees-On-Accreditation/?ID=CYTO Accessed November 6, 2014.
  16. ASC. Facing the future of cytopathology. Available at: http://www.cytopathology.org/wp-content/dynamic_uploads/3439.pdf. Accessed November 4, 2014.
  17. Cytology Education and Learning (CELL) Website. Available @ http://cytologyedlab.org/. Accessed November 4, 2014.
  18. Kane LE, Root RR, Voss JS, et al. Molecular diagnostics, personalized medicine, and the evolving role of the cytotechnologist: an institutional experience. Acta Cytol. 2012; 56(6):678-85.
  19. Robboy SJ, Weintraub S, Horvath AE, et al., for the Workforce Project Work Group. Pathologist workforce in the United States. Arch Pathol Lab Med 2013 Dec; 137(12):1723-32.
  20. Davey DD, Kaplan DR, Michael CW. Strong performance on the Progressive Evaluation of Competency fellowship final examination predicts American Board of Pathology Certification. Journal of the American Society of Cytopathology; 2014:3, 269-273.

 

 

 

 

PROFESSIONAL ADVOCATES AND VOLUNTEERS – ARE YOU ONE?

ASC President’s Blog
Ritu Nayar, MD, MIAC

August 2014

Advocacy is “the act or process of advocating or supporting a cause or proposal” (Merriam Webster) or the “active support of an idea or cause etc.; especially the act of pleading or arguing for something.” (Thesaurus)

All of us advocate frequently, for something or someone, at a personal or professional level.  So why and how is advocacy important to you, as an individual and as a member of the American Society of Cytopathology?

Advocacy raises awareness of the contributions pathology and cytopathology make in supporting local, state and national health care needs and advances the role of pathologists and laboratory professionals as team players in the healthcare system. While the ASC does not directly engage in lobbying, we do strongly support advocacy efforts for pathology and specifically cytopathology through our volunteer members who are extremely active throughout the year in various efforts led by the College of American Pathologists (CAP) and the American Society for Clinical Pathology (ASCP) and their lobbying efforts on behalf of pathology. The CAP works in close collaboration with our ASC leaders and representatives on several legislative/regulatory issues.

Some of our members have asked “what does the ASC do for us in the area of reimbursement and lobbying for our cause and why don’t we know what is happening?”  Most of us know there is a “RUC” and “CPT” committee and a “PCC.” However it was not until the past year, when I participated in and/or observed a lot of these discussions and meetings, that I better understood how much detailed work these groups do and the added value that our ASC volunteers bring to these advocacy efforts. So I wanted to take this opportunity to share some of what I have learned from our volunteers and the outstanding CAP staff:

  1. The AMA/Specialty Society RVS Update Committee (RUC)

This is a volunteer committee comprised of physicians and other health care professionals. The RUC’s mission is to make recommendations to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare Resource-Based Relative Value Scale.  In addition, societies seated in the AMA House of Delegates can also serve on the Advisory Committee to the RUC.  The Advisors attend the RUC meeting and present their societies’ recommendations, which the RUC evaluates.  ASC, CAP, as well as ASCP have appointed members of the RUC Advisory Committee who participate in the deliberations with the RUC and advocate for the specialty.

  1. The AMA Current Procedural Terminology (CPT) and Pathology Coding Caucus (PCC)

CPT is maintained by the CPT Editorial Panel, which meets three times a year to discuss issues associated with new and emerging technologies as well as difficulties encountered with procedures and services and their relation to CPT codes. Supporting the CPT Editorial Panel in its work is a larger body of CPT advisors, the CPT Advisory Committee. The members of this committee are primarily physicians nominated by the national medical specialty societies represented in the AMA House of Delegates.  One of the Advisory Committees’ primary objectives is to serve as a resource to the CPT Editorial Panel by giving advice on procedure coding and appropriate nomenclature as relevant to the member’s specialty.  Similar to the RUC Advisory Committee, ASC has an appointed member to the CPT Advisory Committee.  The Pathology Coding Caucus (PCC) is a partnership of the AMA and other pathology and laboratory groups, which develops consensus recommendations on proposed new and revised CPT codes prior to consideration by the AMA CPT Editorial Panel.  ASC in collaboration with other pathology and laboratory groups contribute regularly to PCC deliberations as part of the work of the AMA CPT Advisory Committee.

It is important to realize that the CPT and the RUC are staffed by physicians and professionals representing the entire house of Medicine.  The CPT and RUC processes are complex, complicated and can be rather laborious.  An incredible number of staff and volunteer hours are spent every day, to thoroughly evaluate each current issue and present the best recommendations on behalf of pathology and cytopathology.

The RUC is a unique multi-specialty committee dedicated to making relative value recommendations for new and revised codes as well as updating RVUs to reflect changes in medical practice. Because of this unique structure, the RUC has created the best possible advocate for physician payment – the physician. It is through the work of these dedicated physicians who contribute their time, energy and knowledge that make the RUC process a success that benefits all practicing physicians.

Although historically, RUC recommendations have had acceptance rates of 90% or more, CMS with its new authorities and directives from the Affordable Care Act has put the RUC activities and recommendations into heightened and intense scrutiny.  More recently, RUC recommendations have had acceptance rates below 80%, which represents a flag for RUC participants to step up to the plate and work harder to infuse more specialty society expertise through the RUC physician work survey process.

I would like to thank our outstanding ASC representatives: Dr. Margaret Havens Neal, ASC-AMA House of Delegate Member and Member RUC – Practice Expense Review Committee; Dr. Swati  Mehrotra, ASC/RUC Advisory Committee representative and Dr. Carol Filomena, ASC/CPT Advisory Committee representative as well as our wonderful colleagues;  Dr. Jonathan Myles, Chair, CAP Economic Affairs Committee and CAP/RUC Advisory Committee representative; Todd Klemp and Ayanna Wooding, Assistant Directors, CAP Economic and Regulatory Affairs, and Pam Johnson Director, CAP Economic and Regulatory Affairs.

As you know, the ASC now has memorandums of understanding (MOU) with the ASCP and the CAP.  At the ASC 2014 Annual Scientific Meeting in Dallas, we will have a CAP-ASC session, Advocating for Our Specialty and Our Patients. How and Why You Should Get Involved,” presented by Dr. Emily Volk, Vice Chair of CAP Council on Government and Professional Affairs (CGPA) and Nora Bowers, CAP staff and patient advocate. The ASCP-ASC session will focus on Emerging Roles for Cytotechnologists: Real-life Examples.  Be sure not to miss these exciting events at the Meeting.

Why should you be an advocate for Cytopathology?

Advocacy does not happen by itself.  The current landscape demands new ways of thinking and doing, be it in medicine/healthcare or any other arena.  We cannot assume that policy makers know what we do and how pathology and laboratory medicine contribute to the health care system. It is extremely important to have a presence and build sustainable relationships at all levels.  We can and should provide ongoing information and updates about our work, and the professional and public value of pathologists and laboratory professionals; specifically the various ways in which our specialty and practitioners contribute to patient care.  The number of people involved in a cause matters and the success of advocacy efforts is usually proportional to the strength of the advocating group.  If you and I don’t speak up for our cause, then others will speak up for their causes which will then be more likely get attention and resources.

THE VALUE OF VOLUNTEERING

A volunteer is “a person who voluntarily undertakes or expresses a willingness to undertake a service” (Merriam Webster) or “a person who performs or offers to perform voluntary service” (Thesaurus)

Central to these definitions is the fact that volunteering should be a choice that is freely made by an individual.  While it involves the desire to help others, volunteering does not exclude other concurrent motivations that encourage an individual to participating in such efforts.  While there are a variety of motivations, consistently ranked high are:  (1) Ability to make a difference, (2) Opportunity to “give back,” (3) Opportunity to learn and gain professional experience, (4) Boosts personal esteem and self-confidence, (5) Builds camaraderie and teamwork, and (6) Saves resources and strengthens communities or groups one works with.

While some may be uncomfortable with the notion that a person can “benefit” from doing volunteer work, there is really nothing wrong with a little “give and take” – both sides win.

I have talked to so many of you who have had wonderful experiences when volunteering in various roles, within and outside the United States. I asked three of our members to share their recent experiences with us:  Janie Roberson, SCT(ASCP) describes her trip to a Mission Hospital in South India- a project supported by an ASC Foundation Advocacy grant; Barbara MeGahey Frian, CT(ASCP), recently went to Botswana as part of ASCP’s Center for Global Health Programs, and Vijayalakshmi Padmanabhan, MBBS, MD shares the highlights of her trip to Peru as part of the CerviCusco program.

As I reflect back on my own training and career over the past 23 years, I can say without doubt, that volunteering and advocating for pathology, cytopathology and the ASC as well as other pathology organizations have been very fulfilling for me at so many levels. I have been mentored by so many wonderful and inspiring people, many of whom have become close personal friends, learned so much, and been able to give back a little to the profession I love.

How can you get Involved?

Among the ASC’s 3000+ membership of pathologists, cytotechnologists and scientists, we are fortunate to have many highly motivated individuals who dedicate their time and effort towards supporting the ASC and Cytopathology. This year, among a total of 294 ASC committee and liaison positions, I was able to assign 145 to new volunteers, and 85% of all those who expressed an interest in being involved were assigned to a committee.  If you would like to offer your time and expertise towards the ASC’s missions of education, advocacy, innovation and teamwork, please take a few minutes to fill out the volunteer form, which can be found on the member section of the ASC Website – no effort is too small!   You can refer to the ASC Website for a complete listing of ASC committees and initiatives.

This year we have advertised a number of volunteer opportunities on the ASC Website. Also, if you have had fruitful volunteer experiences you would like to share with your ASC colleagues, please submit them to ASC (email: lweber@cytopathology.org). Besides volunteering your time and expertise, there are other ways you can support the ASC. Our Foundation has many exciting endeavors that can be further supported by our contributions; and for your younger colleagues and those who are “tech” savvy, the power of social media’s reach to support our profession and professionals cannot be underestimated.

So next time you wonder what your professional organizations and the ASC are doing for you, ask what can I do to help?  Remember “ASC IS MY SOCIETY” – you and I are the ASC!

Acknowledgement:  My thanks to Meg Neal and Todd Klemp for helping me with the details of the RUC/CPT process.

HPV Primary Screening: Considerations for ASC Members

Ritu 2013

Ritu Nayar, MD ASC President

The ASC leadership and its membership are committed to supporting women’s  health and working collaboratively with other pathology and clinical professionals to effectively prevent cervical cancer in the United States.

Primary screening with HPV is now one of three currently available test options for cervical cancer screening. We can best serve our patients by:

a)    Understanding the value, as well as the limitations of various testing options available for cervical cancer screening.
b)    Offering clinically validated testing with adequate quality control in our laboratories.
c)    Keep abreast of the current published scientific data so that we are able to effectively communicate with our clinical colleagues and other professional organizations.

With the FDA approval of the first HPV test for primary cervical cancer screening on April 25th 2014, clinicians in the United States will now have 3 different first line screening options that they may offer to patients: the Pap test, co-testing with Pap and HPV tests, and HPV testing as a stand-alone test. Specifically, the Roche Cobas® HPV Test was approved for primary screening for cervical cancer as a stand-alone test. To date, none of the other FDA-approved HPV tests (Qiagen’s Digene Hybrid capture® 2, Hologic’s Cervista® HPV and Hologic-Genprobe’s APTIMA® HPV Assay) have been approved for this indication. Note that there is no role for low-risk HPV testing in cervical cancer screening and management.

As cytopathologists and cytotechnologists what should we be aware of with respect to discussing this testing option with our clinical colleagues and among ourselves when considering offering this test in our laboratory? Some key considerations are included below.

Which Test has been recently approved for primary cervical cancer screening by the US FDA?

The first, and currently only FDA approved test for Primary HPV screening for cervical cancer in women 25 and older in the United States is the cobas® HPV Test, which is manufactured by Roche Molecular Systems, Incorporated, Pleasanton, California.

The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus (HPV) in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting an additional 12 high- risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).

The cobas® HPV Test was first approved by the FDA in 2011 for use in conjunction with or as a follow-up to a Pap test. The additional approval expands the use of the test as a first-line primary cervical cancer screening test.

Cervical specimens that may be tested with the cobas® HPV Test include the following liquid based collection media and collection device:
• ThinPrep® Pap TestTM PreservCyt® Solution
• Endocervical Brush/Spatula

Details of the test and approval can be found in the cobas® HPV Test package insert and at www.hpv16and18.com. (Ref 1).

What was FDA’s basis for approving the Roche HPV test for primary screening?

The FDA requested the appointed advisory committee to assess whether the cobas® HPV Test is safe and effective for the proposed new intended use as a primary screening test for cervical cancer.
Data supporting the use of the cobas® HPV Test as a primary screening test for cervical cancer included the U.S. based, multicenter, prospective ATHENA study of approximately 40,000 women, ages 25 years and older undergoing routine cervical cancer screening. Women who had a positive Pap test or who screened positive for HPV, as well as a subset of women whose Pap and HPV tests were both negative, underwent a colposcopy and cervical biopsy. All biopsy results were compared to the Pap and cobas® HPV test results. Data from this study, which included three years of follow-up on women who went to colposcopy, suggested that the cobas® HPV Test is safe and effective for this expanded indication for use as a primary screening test (Ref 2-4).

Details of the FDA advisory meeting, including a complete transcript of the proceedings and supporting data are available on the FDA website (Ref 5-6). Additional data from Roche’s ATHENA trial, as well as data pertaining to comparison of HPV only testing at 3 years to Pap/HPV co-testing at 5 year intervals is due to be published later this year.

What should laboratorians be aware of when considering if they should offer HPV primary screening?

Since cervical cancer screening using HPV alone is a new option, with limited long term follow up data, it is important for laboratories who offer HPV primary screening to use methodology that has been FDA-approved for this specific indication and verified in the testing laboratory.  Laboratories should be enrolled in adequate proficiency testing and perform regular quality control and statistical analysis of HPV tests that are used for screening (co-testing/ primary screening) and triage.
Laboratorians should communicate with their clinical colleagues to clarify the various testing modalities that the laboratory is able to offer for cervical cancer screening and provide adequate and clear test options in order to enable appropriate test utilization.

Did the ASC and CETC give any input to the FDA before its approval of the Roche HPV test for Primary Screening?

The Cytopathology Education and Technology Consortium (CETC) member organizations include the American Society of Cytopathology (ASC), the American Society for Clinical Pathology (ASCP), the American Society for Cytotechnology (ASCT), the College of American Pathologists (CAP), the International Academy of Cytology (IAC) and the Papanicolaou Society of Cytopathology (PSC).

The CETC submitted a written statement to the FDA advisory panel for its March 12, 2014 hearing on the Roche PMA, and a summary of the CETC concerns was presented to the panel by CAP CETC liaison and ASC Executive Board member, Dr. Patricia Wasserman.

The CETC stated that
The Pap test and the dedication of professionals like cytotechnologists and pathologists have significantly benefited women’s health by reducing the incidence of, and mortality from, cervical cancer. However, cervical cancer screening in the United States remains opportunistic, with far from uniform test accessibility and patient compliance. It is not an organized national program with patient reminders as in the United Kingdom and other European countries that are considering adoption of primary HPV screening. To avoid an increase in cervical cancer, regular screening is required, with methodologies that provide an optimal balance between sensitivity and specificity and remain readily accessible and affordable for all women.”

The CETC asked the FDA advisory panel to consider the following concerns that may potentially impact safety and efficacy for cervical cancer screening in the United States, if HPV primary screening is approved by the FDA:
(1)Test internal control.
In the Roche package insert for the cobas® HPV test, information regarding specimen adequacy, the internal control for epithelial cellular components and potential interfering substances is limited. The Roche HPV test uses a beta-globin gene internal control as a measure of specimen adequacy; this is not specific for cervical epithelial cells. For example, Roche did not show that beta-globin from inflammatory cells could not cause a false assessment of a specimen as adequate if it contained only inflammatory cells and no epithelial cells. In the ATHENA trial, several morphologically unsatisfactory cytology samples did appear to have valid HPV testing results; however, more problems may arise when this testing is used outside of clinical trials.
(2) HPV Negative Cervical Cancer
As with any laboratory test, the sensitivity of HPV testing is not 100%. A subset of carcinomas, both squamous and glandular, and other tumor types may not be detected by HPV testing. A recent United States cancer registry study found that 9.4% of cervical cancers were HPV negative and an additional 3.2% contained rare HPV subtypes (Ref 7).
(3) HPV Testing Methodology
As laboratorians, CETC cautioned that primary screening should be performed using HPV tests that are FDA-approved for the specific indication of primary cervical cancer screening. The testing laboratory should be CLIA-approved and participate in regular proficiency testing and perform verification and continually monitor quality assurance.
(4) Follow up of Primary HPV screen results
Before primary HPV screening for cervical cancer is adopted in clinical practice, there should be clear evidence-based guidelines for the follow-up of positive and negative tests to prevent loss of women to appropriate follow up and potential increases in cervical cancer incidence.  The prevalence of HR-HPV types varies with demographic populations and the current US population is very diverse, in contrast to the patient populations in the prior European trials. Due to the documentation of HPV-negative squamous cell carcinoma and adenocarcinoma, women should have a morphological examination (Pap test) in their screening history and should not be screened solely with HPV tests. Screening younger women with HPV tests may increase overall patient harm from overtreatment of positive results that detect low grade squamous lesions and women under 30 may be better served using a less expensive, more specific test – the Pap test.

When will clinical management guidelines for HPV Primary Screening be available?

The Roche PMA sought the expanded indication for using HPV as a first-line screening test for the cobas® HPV Test – Roche specifically proposed that women who are 25 years and above can be tested first with the cobas® HPV Test in order to triage them into the appropriate risk groups as follows:
a)    Women who test negative for high-risk HPV tests by the cobas® HPV Test should be followed up in accordance with physician’s assessment of screening and medical history, other risk factors, and professional guidelines.
b)    Women who test positive for HPV genotype 16 and/or 18 by the cobas® HPV Test should be referred to colposcopy.
c)    Women who test high-risk HPV positive for any of the 12 other high-risk HPV types, but are 16 and 18 negative, should be followed up with cytology to assess the need for colposcopy.

The FDA approval of primary HPV screening does not change current medical practice guidelines for cervical cancer screening. Primary screening with HPV alone is currently not included in the consensus guidelines for cervical cancer screening in the U.S. and it will be up to our professional societies to discuss inclusion of such a screening option in future medical practice guidelines. Cervical cancer screening guidelines allow professional societies to distinguish preferred screening algorithms from acceptable screening algorithms. They are also able to provide detailed recommendations for how to follow-up on specific cytology results and/or specific combinations of cytology and HPV test results over time, even for women who do not have immediate colposcopy. A woman who is not sent immediately to colposcopy may be followed up in different ways depending upon her test results, history and clinical findings.

A task force appointed by the Society of Gynecologic Oncology (SGO) and the American Society of Colposcopy and Cervical Pathology (ASCCP) is preparing an interim clinical guidance document for HPV primary screening in the United States. This is expected to be published in the next few months. Drs Diane Davey, Robert Goulart and Ann Moriarty were the joint ASC-ASCP-CAP representatives to this task force. At this time it is not known when other professional societies, including the ACS and USPSTF, will issue updated guidelines for cervical cancer screening.

We know from experience with prior guidelines that it takes substantial time and effort to develop evidence-based algorithms and provide education for providers and patients. In spite of concerted efforts to disseminate the 2012 ASCCP Consensus Guidelines for the management of abnormal cervical cancer screening tests and cancer precursors, there is still significant variation with compliance. Currently, cytology only testing, as well as, co-testing are being used variably in different age groups for cervical cancer screening. It is estimated that co-testing is being utilized in less than 50% of patients in the United States. Thus as with any new testing strategy, the adoption of primary HPV testing will most certainly require time and ongoing monitoring of clinician acceptance, patient compliance, as well as, cost-benefit and outcomes analysis.

As we consider the current and future scientific data and literature, our overriding goal should remain the same – to provide the highest level of quality care to the patients we serve. However, we must remember and reiterate that no screening test is perfect. We cannot eliminate all risk with screening, no matter what is the test or target. The very basis of screening requires that it be done periodically and repeatedly be it a Pap test, mammogram or primary HPV screening.

The choice of cervical screening method may vary for a variety of reasons. Patient and provider preference, geographic, demographic, and socio-economic considerations may all affect the choice of screening modality in a specific country, region, or practice setting. As is well proven, any screening is better than no screening, and we must keep availability and cost to our patients for all of these screening options in the forefront of our discussions.

Selected References

  1. Cobas® HPV Test [package insert, US]. Branchburg, NJ: Roche Molecular Systems, Inc; 2011
  2. Stoler MH, Wright TC, Sharma A, et al. High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study. Am J Clin Pathol. 2011; 135(3):468-475.
  3. Wright TC Jr, Stoler MH, Sharma A, Zhang G, Behrens CM, Wright TL. Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol. 2011; 136: 578-586.
  4. Castle PE, Stoler MH, Wright TC Jr., Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older: a sub analysis of the ATHENA study. Lancet Oncol. 2011; 12(9):880–890.
  5. US FDA Primary HPV Screening Approval- Press Release
  6. US FDA Advisory Meeting materials
  7. Hopenhayn C, Christian A, Christian WJ, et al. Prevalence of Human Papillomavirus Types in Invasive Cervical Cancers From 7 US Cancer Registries Before Vaccine Introduction. Journal of Lower Genital Tract Disease 2014; 18(3). DOI:10.1097/LGT.0b013e3182a577c7

 

 

ASC Presidents Blog, March 2014

President’s Blog
March 14, 2014

Dear Colleagues

First, I would like to summarize the advisory meeting proceedings and the ASC’s participation:

On the morning of 3/12/14 you were provided the link to the FDA advisory meeting materials. Note that Roche is seeking approval for HPV as an alternate primary screening method. The role of the FDA is to determine safety and efficacy of the “candidate” relative to the “comparator”. In this case the comparator is cytology alone, not co-testing. Later that evening we informed the membership that the advisory panel unanimously (13:0) approved that the Cobas DNA test is safe and effective and that the benefits outweigh the risks for this indication. The FDA will take the panels feedback under advisement and in the near future will issue the final FDA decision. Yes -it is more than likely that FDA will approve the Primary Screening claim requested by Roche.

The submission data from Roche was substantial and I encourage you to look at it if you have not done so.

FDA Advisory Committee Information

The advisory panel was made aware that in addition to the Athena trial data submitted and presented by Roche, there is new data from Kaiser that shows that CIN3/cancer risk following a negative HPV test is smaller than after a negative Pap and almost as small as after a negative co-test suggesting the relative safety of primary HPV alone at an appropriate interval, conservatively 3 years. Publications from these sources are in preparation and/or press and will be available in the near future.

A number of questions were asked, and topics discussed during the advisory committee meeting. These included the potential impact of HPV vaccination on the proposed follow up algorithms; screening and follow up in the 25-29 years age group; Roche’s choice of CIN2/3 versus cancer as an end point, histology interobserver variability and adjudication with p16 in the HPV negative subset, and HPV negative cervical cancers. No doubt that for some of these questions there are no clear cut answers yet, however they have been noted by the advisory panel.

Clinicians in the United States will now have 3 different screening options that have different intervals, and different triage algorithms. We know from prior guidelines that it takes substantial time and effort to put together evidence-based algorithms and provide education for providers and patients. In spite of concerted efforts to disseminate the 2012 consensus guidelines for the management of abnormal cervical cancer screening tests and cancer precursors, there is still significant variation with compliance and currently cytology only as well as co-testing are being used variably in different age groups. Thus any new testing strategy will likely require on- going analysis including monitoring compliance, cost- benefit analysis, etc.

I would like to emphasize that the ASC was involved in the comment period for this FDA advisory meeting as well as in planning for future clinical guidance for HPV testing as a screening mechanism for cervical cancer in the United States.

1) Collaborating with our other professional organizations – ASCP, CAP, ASCT and PSC, and under the umbrella of the Cytopathology Education and Technology Consortium (CETC), the ASC submitted written concerns to the FDA panel. The CETC statement, which was read during the FDA meeting public comment period by Dr. Patricia Wasserman (ASC-EB member and CAP-CETC representative), specifically raised the laboratory-related issues of the beta globin control not being specific for epithelial cells (hence the possibility of inadequate specimens being called negative) and those related to the potential (mis)use of Laboratory Developed Tests (LDT), in this case, HPV tests, that are not clinically validated for primary screening. We also addressed the data/references on HPV negative cancers.

The CETC statement emphasized that: “The Pap test and the dedication of professionals like cytotechnologists and pathologists have significantly benefited women’s health by reducing the incidence of, and mortality from, cervical cancer. However, cervical cancer screening in the United States remains opportunistic, with far from uniform test accessibility and patient compliance. It is not an organized national program with patient reminders as in the United Kingdom and other European countries that are considering adoption of primary HPV screening. To avoid an increase in cervical cancer cases, regular screening is required, with methodologies that provide an optimal balance between sensitivity and specificity and remain readily accessible and affordable for all women”

2) The ASC, ASCP and CAP appointed 3 joint representatives-Dr. Diane Davey (ASC Past President, CAP Cytopathology Committee Past Chair and ASC CETC representative), Dr. Robert Goulart (ASCP CETC representative) and Dr. Ann Moriarty (ASC Past President, CAP Cytopathology Committee- Past Chair) who provided the laboratory perspective on a task force appointed by the Society of Gynecologic Oncology (SGO) and ASCCP to prepare a document for clinical guidance on HPV primary screening in the United States. Our representatives have been active in this group since December of 2013. The publication from this group will provide interim guidelines for usage of primary HPV screening and acknowledge the areas of caution, including the laboratory related issues raised by our representatives.

Secondly let’s not forget the other sustained efforts of the ASC leadership and volunteers – which includes so many of you – in proactively moving towards future training and practice models for cytotechnologists and more recently, pathologists.

1) History of ASC Efforts

The history of ASC’s strategic discussions regarding workforce and preparedness for change in practice, especially for cytotechnologists, began in November 2001, followed by consultation with The Forbes Group in 2006. This effort resulted in a report entitled “Plotting the Future of Cytotechnology: An Environmental Analysis of the Driving Forces of Cytology”, which outlines changes in market forces and the relationships between pathologists, clinicians, and other specialists that might lead to the emergence of new professions (or professional roles) in the future. It was recommended that the ASC hold an Alternative Futures Summit to engage potential stakeholders in dialogue encompassing different outcomes identified in the report. A summit was held in November 2009 that produced a white paper titled “Facing the Future of Cytopathology,” which focused on discerning the future needs of our profession. This document remains a valuable resource for future directions for the Cytotechnology professional.

With the challenge of decreasing cervical cytology volumes, many hospital based cytopathology laboratories have seen an increase in non-gynecologic volumes; procedure attendance and some have incorporated molecular testing in cytopathology laboratories. Innovative models, such as that at the Mayo Clinic in Rochester, Minnesota, have already proven the value that cytotechnologists can add in a variety of non-traditional roles in laboratory medicine. At the 2011 Annual ASC meeting in Baltimore, the Current Issues in Cytology session entitled “Transformation in Education and Practice for Cytotechnologists” was presented to discuss the impending changes and showcase the activities of laboratories that have been on the leading edge of adapting to the new environment.

2) Cytotechnology Program Review Committee (CPRC)

Until 2011, when we welcomed ASCP, CAP and ASCT as co-sponsors, the ASC was the sole sponsor of the Cytotechnology Program Review Committee (CPRC). Over the past decade, the CPRC has actively championed an evolution of the traditional cytotechnologist role in order to meet the challenges of changing practice patterns for these professionals. In 2011, the multi-organization sponsored CPRC, led by ASC, formally embarked on implementing a change in the scope of practice for cytotechnologists.

In 2012, the CPRC was sponsored to conduct a 2-day retreat in order to begin implementing Phase 1 of the change in scope of practice for cytotechnologists. This concentrated on curriculum review and revisions for entry level competencies. As a result of the CPRC recommendations, in November 2013, the Commission on Accreditation of Allied Health Education Programs (CAAHEP) approved “The Standards and Guidelines for the Accreditation of Educational Programs in Cytotechnology,” which detailed new entry-level competencies (ELC) for cytotechnologists that go into effect July 2014. The new ELC’s place the curriculum on a modern footing designed to integrate the emerging areas of molecular medicine and digital technology and to provide the basic tools necessary to expand the cytotechnologist’s role in diagnostic pathology.

In 2013, in response to the need to assist programs in locating appropriate resources to teach these new competencies, the CPRC and their sponsors (ASC, ASCP, ASCT, and CAP) participated in the creation of a committee to collect, edit, vet, and write various educational resources for use by Cytotechnology Programs. The members of this Cytology Education Learning Lab (CELL) Committee have already developed this resource. The “CELL” Website will be live shortly!

In February 2014, the CPRC was funded by the sponsors to hold a second two‐day, face‐to‐face meeting to move into Phase 2 of the implementation of changing scope of practice for cytotechnologists and develop recommendations for a new “mid-level pathology practitioner”. The group had a very successful retreat and the sponsors will be getting the recommendations from this group later this month.

3) Workforce shortage

The workforce shortage for laboratory professionals hit us a while ago. However, workforce shortages have been predicted more recently for pathologists, due to possible GME funding cuts and an aging workforce that will soon retire in large numbers. It is the opportune time to transition the current cytotechnologist roles, taking advantage of the strong morphology training plus the newly added skills of these highly trained individuals and develop a midlevel pathology practitioner to support needs of pathologists, patients and the health care system.

Multiple societies have recognized the need for pathologists and laboratorians to work together to address these workforce issues – ASC has actively joined these endeavors at the outset of collaborative discussions. In the past 4 months, the ASC became a member of the multi-society Pathology Roundtable, attended the multi-organization workforce summit and other leadership forums. We will be pursuing a number of initiatives to support our profession and practitioners through these team efforts.

So in summary – the ASC has been preparing judiciously and consistently to meet the challenges related to changing practice patterns that have been predicted for over a decade. This is the time for us to come together, brave the change, and continue to adapt to new roles. There is a lot that cytopathology, cytopathologists and cytotechnologists can contribute in the rapidly evolving health care arena- we need to seize these opportunities. Your leadership is very cognizant of our responsibility to support the needs of our current and future members. Our overriding goal remains the same- to be able to provide the highest level of quality care to the patients we serve.

Remember the ASC vision is “Saving Lives One Cell at a Time through Innovation, Teamwork, Education and Advocacy.”

With best wishes,
Ritu Nayar, MD, MIAC
President, American Society of Cytopathology.