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.

State of the Society by Ritu Nayar, MD, ASC President

Ritu Nayar, MD

Ritu Nayar, MD

State of the Society
Ritu Nayar, MD, ASC President

I would like to take this opportunity to review where the ASC has been, where we are today, and where we are going. Let me begin, however, with some background on the current state of the nation’s health care as it pertains to members of our profession. The basic challenges in the rapidly evolving health care arena are not unique to pathology or cytopathology- namely, a relatively new and evolving health care system, workforce shortages, and economic pressures. With the implementation of the Affordable Healthcare Act, there will be changes in consumer demographics and new delivery systems. These changes, along with an increased emphasis on health information technology and advances in genomic medicine will demand that we, as health care providers, continue to be innovative, revamp our training and education programs, and deliver our services quite differently than we did and perhaps still do today.The issue of workforce shortages in pathology and laboratory medicine has been on the minds of the federal government, our professional societies, and our leaders for some time. Our sister organizations, The College of American Pathologists (CAP) and The American Society of Clinical Pathology (ASCP), have done substantial work in this area.1,2 Although significant shortages already exist in many areas of laboratory medicine, it has been projected that employment of clinical laboratory technologists and technicians will grow by 13% between 2010 and 2020.3 Pathology and laboratory medicine also have an aging workforce, associated with recruitment, and training funding challenges. Consider that pathologists are the second oldest practicing specialty (mean age of 57.5 years).4 The projected increase in the number of practicing pathologists of only 3% during the 2000 to 2020 time frame versus the projected required increase of 23% is very concerning.5-7 The Council on Graduate Medical Education sees graduate medical education as an essential public investment in tomorrow’s health care system that furthers the nation’s goal to attain the triple aims of better health, better health care, and lower costs. Approximately $13 billion per year is invested in graduate medical education, which though a sizable amount, is <1% of the $1.4 trillion of federal and state expenditures on health care.8,9 The Council on Graduate Medical Education believes that better targeting of graduate medical education money by providing more effective training programs will result in a workforce that is better aligned with the country’s future needs.8 Although the medical community is considered to have been slow in responding to changing health care needs, in the past years, a number of new requirements for and from medical schools and accreditation organizations have been put forward. Some of these are already in effect and others need to be implemented in 2014-2015. They include competency-based medical education, accreditation changes such as the Next Accreditation System (NAS), the Clinical Learning Environment Review Program, and milestones, along with new teaching and learning methods such as practice-based learning.

Specifically in cytopathology, our practice is changing and continues to do so, in both gynecologic and nongynecologic areas, bringing with it opportunities for us to be innovative and to take charge of our future. Winston Churchill reminded us that “a pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty.”

So what has ASC done and what are we planning to do to address our evolving professional and member needs in the coming year(s)?
Our past leaders, so many of whom have been my personal mentors and role models, have paved the path for us over the past decade. The history of ASC’s strategic discussions regarding workforce and preparedness began in November 2001, when ASC members assembled with other cytology leaders at the Cytotechnology Education Consensus Retreat, to discuss the challenges facing cytotechnology educational programs, cytology professionals, and employers. Between 2001 and 2006, ASC conducted surveys, gathered information, and explored ways to define the scope of practice of cytotechnologists in the context of workforce needs. Then ASC developed strategies for cytology educators to gear curricula to address those needs. In 2006, The Forbes Group was hired as a consultant and presented the ASC with a report titled “Plotting the Future of Cytotechnology: An Environmental Analysis of the Driving Forces of Cytology.10” This document outlined 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, and it 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 2007 that produced a white paper titled “Facing the Future of Cytopathology,” focused on discerning the future needs of our profession.11 This document remains a valuable resource for future directions for the cytotechnology professional. The Cytotechnology Program Review Committee (CPRC), sponsored solely by the ASC for many years, has championed this cause, and just a few days before our annual meeting 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. 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. The profession needed these changes to allow for the potential of expanded roles in the future. Congratulations and thanks to everyone who worked so hard to get this done!

Today, the ASC has a committed, experienced executive director and staff and a new strategic plan with goals spanning organizational, financial, membership, educational, advocacy, quality, and research-related initiatives. Our greatest asset, however, is you, our members, who come together to support and volunteer to help sustain the ASC and move us forward.

My priorities for the coming year are based on the current “big picture” regarding evolving health care dynamics and the evaluation of our ASC member needs as assessed by surveys and personal communications. So what do our members value about being a part of the ASC family? Professional growth, education, networking, and friendships are high on the list. Thus, I have chosen to focus predominantly on 3 of our strategic goals: education, advocacy, and increasing ASC membership value, with emphasis on teamwork and partnerships.

The ASC’s mission is accomplished in large part due to the energy and dedication of our committee chairs and members toward advancing our strategic goals and keeping our vision alive and focused. This year we have 6 standing committees and 16 ad hoc committees with common responsibilities as well as specific goals. I have put forth expanded initiatives relevant to our challenges and member needs and also appointed additional members to motivate the committees to come up with great ideas and products that will foster our efforts and the ASC mission. In addition, we have 3 ad hoc task forces that have been established to fulfill specific short-term goals. This year, 145 of 294 volunteer positions were new appointees and 85% of new volunteers were assigned to a committee. If you would like to offer your time and expertise and get involved on ASC committees, do 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! The ASC also appoints a large number of liaisons and representatives to various other organizations and committees to collaborate and effectively represent the interests of cytopathology. Please refer to the ASC Website for a complete listing of ASC committee initiatives and members, so that you can review our goals for the coming year.

With respect to ASC’s support of pathologists’ and cytotechnologists’ training and accreditation efforts:

1. The ASC Cytopathology Program Directors Committee will be compiling resources for our residency and fellowship program directors that will help provide guidance for the many new training and accreditation requirements. This committee also organizes the annual meeting’s strategies in cytopathology education session in parallel with the session for cytotechnology training. To ensure representation for cytopathology training and accreditation requirements, the ASC and Papanicolaou Society of Cytopathology (PSC) have joint representation on a newly formed ad hoc Fellowship Directors Committee developed by the Association of Pathology Chairs. The ASC Progressive Evaluation of Competency (PEC) program has proved to be an extremely popular product for residents and fellows and it will be further strengthened in 2014.

2. In 2011, the ASC welcomed ASCP, ASCT and CAP as CPRC co-sponsors. In 2013, the CPRC appointed a subcommittee to undertake the task of providing cytotechnology programs with resources to meet the new entry-level competencies that will take effect in July 2014. The ASC is establishing a specific area on its Websited CELL (Cytology Education and Learning Lab) to support this endeavor. Rest assured that this dynamic collaborative group will represent us well.

I strongly believe in teamwork and that as professional organizations there is more that unites us than divides us. Thus, we have recently taken the following steps to make sure that ASC participates as a partner in organized leadership, ensuring that we are proactively associating ourselves with the right efforts and advocating for our profession.

1. “We can do more with less.” Sounds familiar right? In November 2013, ASC and the Papanicolaou Society of Cytology (PSC) appointed a joint ASC-PSC Task Force to review the “Current and Future Role of Cytologic and Small Biopsy Specimens in Ancillary Testing.” We hope that the document generated by this group will provide good guidance on the value of cytopathology in today’s pathology and personalized medicine practice, while also specifying qualitative and quantitative requirements.

2. ASC has joined the Pathology Collaborative Round Table, which was implemented in January 2013 by the Association of Pathology Chairs with the aim of facilitating networking and communication and promoting synergistic planning about issues and joint initiatives of high priority to our profession.

3. Primary human papillomavirus (HPV) testing is being piloted and/or is near implementation in the United Kingdom and parts of Europe. In the United States, we have a pending premarket approval supplement to the US Food and Drug Administration seeking the addition of a cervical cancer primary screening indication for the cobas HPV test (Roche Molecular Systems).12 The American Society for Colposcopy and Cervical Pathology and the Society for Gynecologic Oncology have organized a committee to provide clinical guidance on primary HPV testing, as a mechanism for cervical cancer screening in the United States. The ASC/CAP/ASCP jointly appointed 2 pathology representatives and 1 alternate to this group, which began its work in November 2013. Guidance from this effort is expected to be forthcoming in 2014.

4. A Multi Society Pathology Workforce Summit has been organized by CAP, Association of Pathology Chairs, ASCP, and USCAP. The goal of this meeting, which is scheduled for December 2013, is 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 affect the workforce’s ability to fulfill its responsibilities to patients, and to identify shared opportunities to advance workforce issues. ASC and our interests will be represented in person at this summit.

5. The ASC collaborates with ASCP, American Society for Cytotechnology, CAP, International Academy of Cytology, and PSC on the Cytopathology Education and Technology Consortium (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.13 In 2013, we updated the CETC policies and goals to align them with the current practice of cytopathology. Look out for an updated HPV test utilization statement to be published in early 2014 by this group, as well as other collaborative efforts that can be best achieved by multisociety participation.

6. The ASC’s Companion Meeting Committee organizes educational sessions at a number of other pathology meetings, in coordination with both national and international professional organizations. In the coming year, we hope to expand these further to include non-pathology organizations and begin to give some awards in recognition of participants’ work in cytopathology.

7. ASC has a memorandum of understanding with the ASCP, and we recently signed a nondisclosure agreement with the CAP to explore additional areas of overlapping interest. We look forward to further increasing collaborations with both of these societies. We are also actively exploring nonpathology organization collaborations.

The above mentioned partnerships pertain to advocacy for our profession; however, my additional goals in the coming year are to increase advocacy efforts with allied health care organizations and patient advocacy groups and to help connect ASC members who wish to volunteer to help with education, training, and hands-on services required in low-resource areas. This charge is among the initiatives assigned to the newly named ASC Public Information and Advocacy Committee.

Our members (and nonmembers) have asked about ASC’s support of the local and state cytopathology organizations. The identified needs include time, and costeffective networking, and continuing medical education credits. Over the past year, the ASC Executive Board cytotechnologists and representatives from the ASCP have been developing a course that will be held in 2014 in California. In addition to the ASCP, the California Society of Pathologists will also participate in this joint endeavor. This upcoming year, the Executive Board will look into how ASC may be able to provide support to sustain local/state cytology societies, and if warranted, the details of such support and a pilot will follow in 2014.
ASC’s educational efforts are strong and appreciated by our members. The Scientific Program and Cyto-eConference committees and The ASC Bulletin Editorial Board must be congratulated for continuing to provide us a wonderful balance of basic research and new clinical applications that keep us current. We now have JASC to add support to the ASC education and research missions. ASC provides a significant number of Accreditation Council for Continuing Medical Education (ACCME) continuing medical education/self-assessment module credits. Make sure you know how to take advantage of free CME and SAMs offered by ASC. In the coming year, ASC will also take the lead on 2 exciting new educational endeavors: (1) establish a standardized terminology for urinary cytology, in collaboration with the International Academy of Cytology, and disseminate it via a print atlas and educational web atlas; and (2) publish the third edition of the cervical cytology Bethesda atlas and update the corresponding Web atlas. Both these educational task forces will ask for your input on draft recommendations on the ASC Website. Please do participate and share your opinion, and stay tuned for the results to be shared in various upcoming national and international forums. A newly named and expanded ASC Website Committee has been charged with coordinating the look, functionality, and ease of finding relevant information for ASC Website users.

In summary, the society is proactively keeping abreast of anticipated changes in the health care arena by: (1) providing continuing education, discussion forums, and timely information to our members; (2) being engaged and present in the right place, at the right time; and (3) partnering with other professional organizations, other health care workers, and patients to help shape the future of our profession. These initiatives are true to the ASC visiondSaving Lives One Cell at a Time through innovation, teamwork, education, and advocacy. I am excited and honored to have been given the opportunity to lead our wonderful society and look forward to “roaring” with all of you in the coming year! Thank you in advance for your dedication, commitment, and hard work on behalf of the ASC, cytopathology, and the patients we serve.

References
1. 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 4, 2013.
2. Robboy SJ, Weintraub S, Horvath AE, et al., for the Workforce Project Work Group. Pathologist workforce in the United States [e-pub ahead of print]. Arch Pathol Lab Med. http://dx.doi.org/10.5858/arpa.2013-0200-OA, Accessed November 4, 2013.
3. Department of Labor, Bureau of Labor Statistics. Employment projections. May 2012. Available at: http://www.bls.gov/emp/ep_table_201. htm. Accessed November 4, 2013.
4. AAMC 2012 Physician Specialty Data Book. Available at: https://www.aamc.org/data/. Accessed November 30, 2013.
5. Health Resources and Services Administration. Physician supply and demand: projections to 2020. Available at: http://bhpr.hrsa.gov/healthworkforce/supplydemand/medicine/physician2020projections.pdf. Accessed November 4, 2013.
6. American Association of Medical Colleges. The complexities of physician supply and demand: projections through 2025. Available at: http://www.innovationlabs.com/pa_future/1/background_docs/AAMC%20Complexities%20of%20physician%20demand,%202008.pdf. Accessed November 5, 2013.
7. The physician workforce: projections and research into current issues affecting supply and demand. U.S. Department of Health and Human Services, Health Resources and Services Administration. December 2008. Accessed November 30, 2013.
8. Council on Graduate Medical Education. Twenty-First report: improving value in graduatemedical education.Available at: http://www.hrsa.gov/advisorycommittees/bhpradvisory/cogme/Reports/twentyfirstreport. Accessed November 4, 2013.
9. Centers for Medicare and Medicaid Services. National health expenditure projections 2009-2019: forecast summary. Available at: http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trendsand- Reports/NationalHealthExpendData/downloads/proj2009.pdf. Accessed November 4, 2013.
10. The Forbes Group. Plotting the future of cytotechnology: an environmental analysis of the driving forces of cytology. Available at: www. cytopathology.org. Accessed November 4, 2013.
11. ASC. Facing the future of cytopathology. Available at: http://www.cytopathology.org/wp-content/dynamic_uploads/3439.pdf. Accessed November 4, 2013.
12. Roche Molecular Diagnostics. Roche submits filing to FDA for cervical cancer primary screening indication for cobas HPV test. Available at: http://molecular.roche.com/News/LocalNews/Pages/RochesubmitsfilingtoFDAforcervicalcancerprimaryscreeningindication forcobasHPVTest.aspx. Accessed November 4, 2013.
13. ASC Bulletin September 2013. Available at: http://www.cytopathology.org/wp-content/uploads/2006/02/The-ASC-Bulletin-September-2013. pdf. Accessed November 30, 2013.

Chasing Mavericks

Chasing Mavericks is a movie about legendary big wave surfer Jay Moriarity. For those who like to see people rocket down ridiculously big waves just for the thrill of it (like me), the movie is a treat. Nevertheless, the critical response to the movie has been uneven. Interestingly, one reviewer pointed out that surfer movies in general are particularly hard to bring to the screen. As an audience we like movies that have a plot that moves from early struggles to a successful climax. There is a beginning, middle and end; however, surfing isn’t like that. Of course surfers are always seeking out that one big wave and that one perfect ride and as soon as they achieve it, they go right back looking for another wave to ride. There is no end to the story, no matter how fantastic any one wave, there is always another one just behind it.

In some ways this also describes cytology, and cytology screening in particular. Perhaps this is why cytology has struggled to advertise itself to the American public. Cytologists screen day in and day out. Everyone is looking for that one great case where they identify a single abnormal cell that makes all the difference in the life of a patient. For the patient, that cell is part of a story that is easy to tell. Everything was fine until crisis struck, and then with the help of a wide variety of health care professionals, the patient successfully overcomes the crisis.

For the cytologist who found that cell, there is of course satisfaction. Perhaps someone in the laboratory may even point out how great a call it was. But more often than not, few people in the laboratory will know what happened, and certainly no one outside the laboratory will think about how lucky that patient was to have that cytologist looking at his or her slides, especially if it was a really great call. Instead, that cytologist will go back to work and start screening more cases. They rode the big one, they did what everyone in the field wants to achieve someday, but the mission doesn’t change. No matter how great the call, there is always another wave coming up right behind it, and that does not fit well on the American movie screen.

But as the surfers in the movie point out, it doesn’t really matter. Sure they want their story on the screen, they want people to understand what they are doing and appreciate it. But at the end of the day all that really matters is that they are doing it, and are going to keep doing it because that is their mission in life. Perhaps we should learn something from these surfers, who are always quick to recognize when one of their own has succeeded, since no one else is likely to recognize us. We in the laboratory should all take a little more time to recognize the individuals who have succeeded in catching that big wave and identified a cell that may change someone’s life. We should acknowledge that it is those who screen who are really the big wave surfers of our world!

Andrew Renshaw, MD
ASC President, 2012-2013

Designing an Anatomic Pathology Practitioner

For several years now there has been a push to revise and update training for cytotechnologists to ensure that they are prepared for the needs of the future. Both the American Society for Clinical Pathology and the College of American Pathologists have submitted letter to the Cytotechnology Program Review Committee (CPRC) detailing specific areas that they would like to see covered in all cytotechnology training programs, and the CPRC has taken these suggestions to heart and is actively engaged in the process of implementing these recommendations as part of the Standards and Guidelines for the Accreditation of Educational Programs in Cytotechnology

As a practicing pathologist and cytologist and as a member of the American Society of Cytopathology, I strongly support these efforts. I look forward to the day when the cytotechnologists in my hospital system can be aiding in the interpretation not only of tests that are traditionally in the area of clinical pathology (FISH, molecular diagnostics, laboratory management) but also in areas that are traditionally the purview of pathologists (special stains, immunohistochemistry, primary sign out of non-gynecologic cytology). I foresee a time when the name “cytotechnologist” may be too restrictive, and titles such as “Anatomic Pathology Practitioner” may be more appropriate.

Nevertheless, while I strongly support these efforts, I do see an area where my vision of the future is slightly different than the one that is described in these letters. In these letters, the rivalry between cytotechnologists and medical technologists/medical technicians (MTs) remains strong today. While MTs are willing to give up very specific and limited areas of their field, they most certainly are hanging on tight to their primary role in the clinical laboratory. This makes sense – like cytotechnologists, MTs are under pressure from management to justify their utility, and I would be hanging on tight if I were in their shoes as well. Since there are many more MTs than cytotechnologists, in any competition between these two specialties, cytotechnologists can not come out ahead. Does this matter for the future of the cytotechnology?

I would say yes. There is an opportunity out there that I have not seen clearly articulated in any of these letters to date. That opportunity is in the very small hospitals (where I spend most of my time), not the academic centers. There are many small hospitals in this country, and there is a real need for assistants to pathologists in this setting. In academic centers, there is enough work to keep an “anatomic pathology practitioner” busy just doing anatomic pathology. In small hospitals there is not. In my hospital there are 1-2 hours of anatomic pathology a day, and in no circumstance would I ever be able to hire an “anatomic pathology practitioner” for this setting. It’s simply not a financially viable arrangement. On the other hand, if I could hire some one who can cut the frozen, examine it at the microscope (with my help via telepathology), do the rest of the AP processing, and then work in the clinical laboratory for the remaining 6 hours of the shift, that would be highly attractive to many pathology groups and hospitals. What I am describing of course is a cytotechnologists/histotechnologist/medical technologist hybrid.

Other specialties have also used these small hospitals to gain acceptance as full -fledged members of their health care teams. While nurse anesthetists work in larger hospitals under the direct supervision of anesthesiologists it is their role in smaller hospitals, where they are often the only person on site, and where the extent of what they can actually do has been demonstrated. The same could happen for cytotechnologists.
But can we actually get to this point? I believe the key step to making this happen is for cytotechnologists to give up – they are never going to win a fight with MTs. Instead they should create a hybrid program that gives them just enough qualification to work in the clinical laboratory, but then focus on developing their anatomic pathology skills. While there are many models that can successfully enlarge the practice sphere of cytotechnologists, if they really want to gain acceptance as full-fledged anatomic pathology specialists, perhaps the easiest route is through smaller hospitals. A license that contains permission to practice in the clinical laboratory is the key to greater responsibility in the anatomic pathology world.

Andrew Renshaw, MD
ASC President, 2012-2013

When is Lean too Lean?

“Lean” manufacturing or management is a popular program to improve the quality and productivity of laboratory operations, including cytology operations.  According to Wikipedia, “Lean,” is a production practice that considers the expenditure of resources for any goal other than the creation of value for the end customer to be wasteful, and thus a target for elimination…  Essentially, lean is centered on preserving value with less work. Lean manufacturing is a management philosophy derived mostly from the Toyota Production System (TPS).” This approach has been used to improve the performance of laboratories around the world.

While I think this approach is quite valuable for managing laboratories, every time I hear someone talk about it I am immediately reminded of Charles Perrow’s classic text, “Normal Accidents.”  In this text he reviews how and why accidents occur in high risk situations, including the airline and nuclear power industries.  In brief, he distinguishes between two different approaches to management, “tightly coupled” and “loosely coupled.”  In a tightly coupled scenario, the productivity is very high and there is no waste because the process has been streamlined to a very high degree.  In a loosely coupled scenario, things are not as streamlined, there is more redundancy, and there is simply more time and manpower to make sure a task gets done properly.  His essential point is that as long as humans are part of a process, there will always be mistakes.  In a loosely coupled process, there is time and opportunity for a human to catch a mistake before an accident occurs; while in a highly coupled process, there is less redundancy, and it is much more likely that a human mistake will lead to an accident.  His review of the history of accidents in high risk occupations repeatedly shows that accidents tend to occur more often and be more severe in a tightly coupled situation.  Not surprisingly, he suggests that we should not make industries where the consequences of an accident are severe tightly coupled organizations.

At first glance “Lean” seems to be all about creating a tightly coupled scenario.  The process is streamlined as much as possible to eliminate waste and redundancy and to improve productivity.  But this is not quite right.  Although I am no expert on “Lean,” in my experience, managers can implement “Lean” in two very different ways.  In the first way the process is streamlined to eliminate as many steps as possible, because each step is another chance for a human to make a mistake.  The less opportunities given to humans to err, the fewer errors there will be.  This is “Lean” the way I think it was meant to be implemented.  Obviously the other way to implement “Lean” is to eliminate the redundancy in a system.  While I am not sure this is what the originators of “Lean” intended, it certainly is a way in which it is in fact implemented.  While this will improve productivity, it will not reduce the overall chance of error since it does not reduce the opportunities for error.  Instead, it simply eliminates any chance to detect and correct any errors that might be in the system.  And since no one is looking for errors, it is not surprising that no one is finding any, and it is all too easy for everyone to think that the system is working just fine.

As we all head into the future of medical care, there will be more and more pressure to increase the productivity of every laboratory.  In this setting, it will be important for cytologists to recognize that we too work in a high risk environment where errors can have grave consequences.  We need to be ever vigilant that there are two very different approaches to streamlining a laboratory, and the impact on errors of these approaches is very different.  Management may not always be able to distinguish between the two results simply because one may not always look for errors.  Eliminating unnecessary steps to reduce the opportunity for humans to err is always beneficial, eliminating redundancy is not.  As my friends who do not do cytology always ask me when I complain about how hard my job can be, “why don’t you just look at every case twice?”  I have yet to come up with a very good answer to the question.

Andrew A. Renshaw, MD