The glory of gardening: hands in the dirt, head in the sun, heart with nature. To nurture a garden is to feed not just the body, but the soul.
— Alfred Austin
I want to talk about the importance of soil–and foundations. Soil is more than just dirt; it is teaming with essential microbial life and potential. If it’s healthy, it provides the necessary nutrients and minerals needed for growth. But soil requires attention, too- we all know that crop rotation was introduced due to soil depletion. Farmers understand that one needs to nourish the soil so that it can nourish plants. Sometimes that just means letting it lie, but sometimes it means composting, tilling, burning, slashing and mulching.
A large part of the ASC “soil” is our collaboration with otherorganizations- areas into which we can extend our roots and form symbiotic relationships. I’ve spent the first few months of my term solidifying relationships and creating new ones, as have many of the ASC leaders. Late last year, ASC President Edmund Cibas wrote a heartfelt letter to Dr John Kirby, Dean of the College of the Environment and Life Sciences, University of Rhode Island, to implore him to reconsider the closure of their excellent Cytotechnology Program. In it, he emphasized the changing roles of cytotechnologists and their contributions to cancer diagnoses other than Pap testing. The University of Rhode Island Cytotechnology Program services a large northeastern region and its loss would adversely impact personalized care to regional oncology patients. I’m pleased to report that his efforts, and those of the Program Director, Barbara Klitz MS, CT (ASCP), had the desired effect of keeping the program open. By unanimous decision, this program now falls under the Cell and Molecular Biology Department- a perfect fit! If you know of any potential cytotechnology student candidates, have them check out the University of Rhode Island program for enrollment, so that they may plant their feet in that rich soil.
Garden Soils are Microbiomes
One of my first actions was to write a personal letter to President R. Bruce Williams MD, College of American Pathologists (CAP), offering to partner with their organization for the See, Test and Treat Program to offer cervical cancer screening services to underserved women. In addition, we are exploring ways to team up on defining new roles for cytotechnologists to address future cytopathology workforce needs. The closure of cytotechnology (CT) schools is disturbing, but it also opens up opportunity to shift the focus of CT training from screening to supportive roles that advance newer oncology testing techniques, such as fluorescent in-situ hybridization (FISH), rapid on-site evaluation (ROSE) of minimally-invasive procedural specimens for adequacy and triage, and specimen preparation/selection for molecular analysis. The CAP also sponsors a National Pathology Organizations meeting of 9 organization which met February 9th to coordinate advocacy efforts. Common shared interests included the status of laboratory workforces, including shortages of cytotechnologists, medical technologists, and forensic pathologists; responses to FDA laboratory developed procedures and Centers for Medicare and Medicaid’s (CMS) request for information (RIF) on next-generation sequencing reimbursement; and support for graduate medical education and research. All of the organizations, including ASC, agreed to collaborate as a unified voice on common issues.
Cytology’s Role in Next Generation Sequencing testing
One of the ways that the ASC showed its support for sister organizations was in our response to CMS’s RIF on next-generation sequencing (NGS) reimbursement. In our on-line public comment response, ASC supported the Association for Molecular Pathology’s position by cautioning against the stringently drafted reimbursement guidelines for NGS testing. The ASC noted the unduly restrictive conditions that limit reimbursement to patients with advanced cancer and highlighted the important role that cytology plays in providing tissue for NGS testing. The restrictive proposal would exclude cytology specimens from reimbursement, because these require laboratory-developed procedures (LDP) for validation of ancillary tests performed. This would bar a large proportion of oncology patients from critical diagnostic and therapeutic/prognostic tests if cytology specimens are obtained.
Not Just Anyone Can Do Cytology…
The ASC is currently working in cooperation with several pathology organizations to formulate a response to a recent CMS call for public comment regarding Clinical Laboratory Act Amendment (CLIA) changes to laboratory testing and technical supervisory personnel. Briefly, the CMS is asking whether a nursing degree (Bachelor of Science in Nursing) qualifies individuals to perform laboratory testing and/or act as technical consultants. They also invite other proposed changes to existing CLIA personnel requirements. The Government Affairs and Economic Policy Committee provided me with an in-depth outline of the issues and background supporting data and our response is in development. Fortunately, CLIA protects cytotechnologists with very stringent personnel requirements and we all agree not to disturb that soil.
Self-Collected Pap tests?
Along other regulatory lines, the ASC was represented at a January 11th meeting of the FDA seeking public comment on the feasibility of introducing self-collection devices for Pap testing. Paul Staats, MD gave an astute presentation on the issues, problems and risks of self-collection devices for cytology, and Dorothy Rosenthal, MD provided insight on logistics and the potential chemical dangers to patients. I issued an ASC statement at the end of the meeting emphasizing our concerns that women might opt-out of clinical visits in favor of self-testing, with the potential ill effect of increasing the rates of cervical cancer in previously well-screened populations through extended delays in follow up. Although the FDA specifically did not address self-testing for primary HPV testing as a cervical cancer screening test, this is certain to be soon on the docket for discussion.
A little soil disruption can go a long way: the ASC voted to remain neutral in the ongoing discussion about Maintenance of Certification (MOC) and the requirement by many Specialty Boards for a re-certification examination every 10 years. However, pathology is fortunate in that the American Board of Pathology (ABP), the last specialty to introduce MOC, remains on the cutting edge of exploring reasonable alternatives to document competency of its diplomates. As a step towards easing the pain of reporting, the ABP is collaborating with the Accreditation Council for Continuing Medical Education (ACCME) to create automated reporting of a diplomate’s educational and practice improvement activities for MOC to the ABP. The registration of educational activities and reporting of diplomates’ completion data to the ABP is done by CME accredited providers, using the ACCME’s Program and Activity Reporting System (PARS). PARS is a web‐based system that collects data about educational activities. Beginning in 2018, PARS will be available for CME accredited providers, such as the ASC, to register their educational activities for MOC and report diplomate completion data to the ABP. CME accredited providers will also be able to identify and categorize their CME, SAMs, and Part IV activities that will be searchable by diplomates in ACCME’s CME Finder.
ASC’s Most Supportive Microbe
There is always a “most prevalent” organism (organization) that supports a microbiome, and for the ASC, it is the CETC. The Cytopathology Education and Technology Consortium is a comprised of representatives from the American Society of Cytopathology (ASC), American Society for Clinical Pathology (ASCP), American Society for Cytotechnology (ASCT), College of American Pathologists (CAP), International Academy of Cytopathology (IAC) and the Papanicolaou Society of Cytopathology (PSC). The consortium has been very active lately with multiorganizational responses to suggested guidelines or governmental calls for information. In October 2017, CETC submitted a succinct, coordinated response to the United States Preventive Service Task Force cautioning on their recommended guidelines to introduce primary HPV screening for cervical cancer without sufficient longitudinal evidence. Similarly, they outlined laboratory concerns about Pap test self-collection devices for submission to the FDA. Ritu Nayar, MD, an ASC former President, is the CETC’s representative on the American Society for Colposcopic and Cervical Pathology (ASCCP)- National Cancer Institutes (NCI) working group for risk-based guidelines to follow up abnormal cervical cancer screening tests. The CETC has been the watchdog for our organization; quickly bringing important issues to our attention and coordinating solutions. It is truly a symbiotic relationship and highly valued.
The sun is setting, my hands are dirty, but I can’t go wash up without mentioning one other critical partner- the College of American Pathologists. Through the CAP Center, the ASC and 7 other societies have published guidelines for the appropriate collection and handling of thoracic specimens for laboratory testing, soon to be published. Sinchita Roy-Chowdhuri, MD, a molecular and cytopathologist, is the Co-Chair of this critical consortium. Cytology specimens play a central role in reducing the morbidity and mortality of lung cancer diagnoses, and our seat at this table was critical to ensure that patients continued to have a cytology alternative for diagnosis.
The soil is prepared…Next up- planting seeds.