The Best Laid Plans: A “Trial by Fire”

From around 2009 to 2016, I worked very closely with a USA-trained surgeon, Dr. Brian Camazine of Earthwide Surgical Foundation, who visits Nigerian Christian Hospital in Aba, Nigeria for one month every quarter. He performs between 200 to 300 surgeries, which produce 40 to 60 surgical pathology specimens each visit.  Dr. Camazine has invested time, energy, and money into training local Nigerians in surgical skills, acquiring surgical and medical supplies to support his patient population, and following up all of his patients with Skype clinics after he returns.

My role in Dr. Camazine’s activities was to receive the surgical pathology samples, process them, and return results for him as quickly as possible. When Dr. Camazine contacted me, there was no pathology laboratory at NCH. Dr. Camazine uses a heavily subsidized model for all of the services provided at NCH such that a patient may pay ~$200 for a surgery (complete care including pathology) that would have cost them $2,000 to $4000 elsewhere in Nigeria. My hospital at the time had an ongoing project of a similar fashion with several sites in Africa but the costs of that program were growing. Dr. Camazine agreed to pay a fee of $25 per sample to my hospital to offset the technical costs of our laboratory processing the samples, and I provided all diagnostic results pro bono. Dr. Camazine was only charging patients $20 per case for pathology; thus, he subsidized the service further.

I had many long and difficult discussions with Dr. Camazine about this program and how we needed to focus on a sustainable solution that did not involve transport to the US for processing for many reasons including (but not limited to): a) danger and difficulty with sending tissue, b) long turnaround time because of shipping delays, c) chain of custody and requisition challenges, and d) capacity building in pathology. We kept at it with this long-term plan in mind but, as I departed my hospital to join ASCP in 2016, a drastic decision had to be made because I would no longer be able to shepherd this service. Dr. Camazine reached out locally to Nigerian laboratories and was fortunate to meet Dr. Chidi Onwuka from the Department of Histopathology at the University of Uyo Teaching Hospital. Brian and Chidi came to a feasible financial arrangement and, with the closeness of the laboratory, Chidi can return results to Brian in about 1 week (Meet Chidi and read Brian’s Blog here). This was a great success for Brian and Chidi because it represented moving from a non-sustainable, bridging program (i.e., what I had set up with Brian) to a permanent solution with the local laboratory. For over two years, Chidi has provided high quality service with quick turnaround time and massively improved the patient care journey for NCH patients.

On June 27th, 2018, however, that complete pathology solution came to a screeching halt when a fire swept through the laboratory and destroyed all of the equipment and reagents. The laboratory in question had just been completely updated with 40 Million Naira (~$115,000 USD) worth of equipment and upgrades, but it was all lost. Dr. Chidi reached out to Brian, myself, and many others with an urgent request to help him get a replacement laboratory up and running. After so much success, it was heartbreaking to hear such a loss had occurred.

IMG_20180627_143654 (1).jpg

The ASCP Partners for Cancer Diagnosis and Treatment in Africa Initiative was launched in 2015 with a goal of bringing 100% access to cancer diagnostics services to all patients. Although the population of patients Brian cares for and Chidi diagnoses are within Africa and within the scope of the Partners Initiative, at the time of the fire, there were at least 10 laboratory projects (including equipment, training, IHC, telepathology, etc.) in process through the Partners project. We were seemingly “at capacity” to help. What could we do? Although we have ASCP member volunteers that donate equipment, we have a waiting list of labs wanting to receive the equipment. Although Brian and Chidi are my colleagues and friends, the distribution of global health resources, assistance, and capacity should always be done with equity. As part of the Partners Initiative, ASCP Center for Global Health acquires equipment (typically through donation which means donor requirements of the local countries) and covers shipping costs to move the equipment to the recipient sites but we had not yet formalized this process. But, for Chidi, I simply didn’t have the equipment available to send.

Then, I received a WhatsApp message from Chidi on August 3rd with a small bit of good news. He had located a microtome in the USA that he could purchase; however, he did not have sufficient funds to ship the equipment. Now, finally, ASCP could help him! But it was not quite that easy!

ASCP staff member Dr. Debby Basu got the microtome in the USA to Chidi in Nigeria. This was not an easy task. Debby faced two major challenges for organizing Chidi’s shipment. First, she had to establish key templates and tools necessary to facilitate donation. Although we have several sets of donated equipment that are to be shipped from ASCP to other sites, Chidi’s microtome was the first actual piece of equipment that would go with our new shipping agent. As this was our first shipment with Bollore, she first had to work with Bollore to determine what documentation ASCP was responsible for providing. She then developed the in-house documents, templates and tools needed to facilitate shipment using Bollore’s services (e.g. commercial invoice, packing list, Shipper’s Letter of Instructions (SLI) Form (customs information), donor letters, etc.). She served as the liaison between the original vendor, recipient and shipper to make sure that donation and shipping documentation was consistent, and that information was clear and available to all parties. The second challenge was understanding the complex international shipping guidelines for exporting scientific instruments and goods on US side and importing donation on receiving end. To address this on the domestic side, she worked closely with the shipper directly to clarify domestic customs guidelines specific to the context of the items being shipped and ensure customs documentation was completed appropriately. On the Nigerian side, she connected Chidi to Bollore’s Nigeria-based shipping team to establish a local point of contact for him. She then coordinated with both the US-based and Nigeria-based shipping teams to clarify country-specific importation requirements and provide Chidi with necessary documentation to ensure smooth receipt of instrument. It had been ASCP’s intention to use Bollore for the donation program but Chidi’s emergency pushed our agenda forward and Debby was able to race into action to make the process go. Now, Chidi has his microtome (and is replacing his other equipment) and ASCP’s shipping donation program has its process finalized for the next series of donations.

SPC L4 (1).jpg

ASCP is so grateful to all of our members and member volunteers who have made the Partners Initiative a functional and impactful global health program. We are careful in our assessments, planning, and development of implementation plans with each of our sites and their leadership. However, terrible things happen unexpectantly. We hope that ASCP can always be a light in the dark when all others have gone out.

 

milner-small

-Dan Milner, MD, MSc, spent 10 years at Harvard where he taught pathology, microbiology, and infectious disease. He began working in Africa in 1997 as a medical student and has built an international reputation as an expert in cerebral malaria. In his current role as Chief Medical officer of ASCP, he leads all PEPFAR activities as well as the Partners for Cancer Diagnosis and Treatment in Africa Initiative.

Innovative Diagnostics for the Developing World

My last two posts have focused on the WHO Essential Diagnostics List (EDL). The EDL, modeled after the Essential Medicines List, is meant to serve as a model guide for countries to use in the development of laboratory services for diagnosis, treatment, and monitoring of common diseases. The EDL is meant to be tailored to an individual nations disease burden, and India is on track to be the first country with a country-specific EDL. I think this is a tremendous step forward for the field of laboratory medicine worldwide, but I do wonder how this will roll out Low or Middle Income Countries (LMIC). How we will got from a list (actually a draft of a list) to real-time diagnostics in the developing world? Let’s take a step back and look at what access to laboratory testing really looks like, and then discuss some innovative diagnostics that might help increase access to useful diagnostics.

In the US, we have many labs tests available – so much so that laboratory utilization has become a very real area of study with groups like Choosing Wisely, PLUGS, and Preventing Overdiagnosis dedicated to helping guide appropriate use of in-vitro diagnostics (IVDs). The US has over 250,000 accredited laboratories, and 18,000 clinical pathologists. That’s about 5.7 pathologists per 100,000 people. In contrast, the continent of Africa has about 1 million people per pathologist, and some African countries have over 5 million people per pathologist. It’s difficult to find a number of laboratories in LMICS, because many are mom and pop type shops that aren’t registered with the Ministry/Department of Health. Test menus are often limited to cell counts and rapid testing, and proficiency testing or quality control is not practiced.

Challenges to building laboratory capacity in LMICs are environment, economics, and education. Environmental challenges include extreme temperatures, limited electricity, and limited access to water. Some point of care options that might be able to work in these environments just aren’t affordable. Many people in LMICS make around $2 USD a day and a $10 iStat/Piccolo/your favorite POC chemistry device cartridge is just out of reach especially if the testing needs to be repeated frequently for monitoring disease progression. Lastly, education remains a challenge as laboratory medicine including not not only technical skills but also the use and interpretation of lab tests is not frequently taught in LMICS.

However, there are many different innovative diagnostics being debuted or in development with these challenges in mind. There are definitely trends in the area of new diagnostics for the developing world. The most distinctive trends are: smartphone imaging, smartphone spectrophotometers, transdermal testing, and paper based sample collection. In my next few posts, I’ll take us through examples of each of these, and I’ll start now with smartphone imaging.

Smartphone imaging is essentially using light boxes, cameras, or apps, to turn a smartphone into an imaging device. Smartphones are even being used as simple ultrasounds! A smartphone microscope can be useful in diagnosing tropical infectious diseases. A good example is the LoaScope, developed by the Fletcher Lab at UC Berkeley. Dr. Daniel Fletcher is known as the “father of the cell phone microscope”. The LoaScope is a mobile phone based microscopy platform plus an app-based algorithm for the detection of L. Loa. The device is elegantly simple: a 3D printed case with a rest of the mobile phone. The case contains a USB port, bluetooth controller board, and LED array, and a carriage for a capillary slide. Blood is introduced to the capillary slide and imaged by the phone. A 5 sec video is captured by the phone, and then analyzed via app that uses a algorithm based on the the wiggling motion of the loa worm. The algorithm actually distinguishes the movement of blood cells as the loa worms move between them! The interpretation of the video lets the user know if the parasite is present or not present. Another bonus the device is that a georeference is captured with every video, which is great for epidemiological studies. In 2017, the LoaScope was used by the NIAID to testing over 16,000 subjects in Cameroon. Because of the LoaScope, over 15,000 subjects were successfully treated with ivermectin without serious complications.

There are some key elements to the LoaScope that are common across the new, innovative diagnostics for the developing world. First, the 3D printed case. 3D printing seems to really be helping this field jump ahead by decreasing the costs associated with creating the physical structure of the devices. Secondly, the device does not require special specimen preparation, nor does it need reagents. Lastly, a simple read-out is a available to the user in real time.

In summary, the EDL is great for telling us what test are, well, essential. Innovative diagnostics are going to help us get to those hard-to-reach places. I look forward to continuing to investigate these with you!

 

Sarah Brown Headshot_small

Sarah Riley, PhD, DABCC, is an Assistant Professor of Pediatrics and Pathology and Immunology at Washington University in St. Louis School of Medicine. She is passionate about bringing the lab out of the basement and into the forefront of global health.  

Vending Laboratory Safety

When you put your money into a vending machine, there is always a gamble. There is a risk of the machine not working- it will take your money but not dispense any products, or the item might just get stuck inside the machine and no amount of banging or tipping will help. As humans, though, we take that risk, and the “danger” is only the loss of some money.

The potential danger for a patient in the hospital can be higher. For years, healthcare organizations have been working with other agencies to improve patient safety. Two professions that often serve as the gold standards of safety culture are the airline and nuclear industries. I have seen many speakers over the years from those agencies give amazing speeches on attaining such high safety ratings. On my more cynical days, I often think that hospital caregivers will probably never reach the same level of safety that is seen in the nuclear and airline industries, and I feel there is a “logical” reason for that. If a pilot or an employee at a nuclear plant makes an error, it potentially places his or her own life at risk, so more attention is paid and fewer errors are made. If an employee makes a mistake when treating patients, the error affects the patient and not the employee, so paying constant attention may not seem as urgent to the worker (I told you these were cynical thoughts).

Now let’s go back to the vending machine. There is some risk to take when putting money into the machine, but once the money is accepted, we feel free to make our selection. Now, if you’ve ever watched someone make such a selection, you may notice that they will not risk making a mistake- they will check, double-check, and even triple-check to make sure they press the right button combination so they get the correct item. The outcome of any mistake made here directly affects the person craving that specific soda or candy bar, so the caution taken to ensure a proper selection is greater. Is that just human behavior? Do we make safer choices if the risk directly affects us?

If that theory is true, then laboratory employees should always work safely. They should always wear proper PPE, they should never eat or drink in the labs, and they would never use their cell phones in the department. Yet many lab safety professionals know that these unsafe behaviors still exist, even in today’s world where we handle highly infectious organisms and deal with bloodborne pathogens daily. If unsafe behaviors lead to exposure- to harm that directly affects the employee- why do these behaviors remain? What’s missing from the picture? I believe the answer lies somewhere between complacency and education, but I also believe both can be handled with increased safety awareness.

Staff who have been in the lab for many years can lose their respect for the chemicals and samples they handle every day. They know that they have worked with them for many years with no negative outcomes, and older lab employees remember the days when all of those unsafe behaviors ran rampantly. Ask a mature lab tech about smoking in the lab, placing party casseroles in the microbiology incubator to keep it warm for the party, and even mouth pipetting. Many laboratory employees worked in environments like that and came out unscathed. But not everyone did.

The reason OSHA and other lab accrediting agencies put forth more stringent safety regulations over the years is because so many lab employees were infected, injured, or killed as a direct result of those unsafe actions. Even in the span of my ten years in lab safety, I can tell a different horror story to each person who says they are fine not paying attention to safety rules. It’s important to do that. Injuries and exposures occur every day in labs, and if they happen in your lab, it is vital the story is told to other staff. Transparency and discussing methods of prevention with staff makes an impact because it makes the danger real and more personal. If you’re in a lab where accidents are rare, that’s great- but make sure you continually raise awareness of the inherent dangers in the lab work place by finding stories of events in other labs and talking about them. Tell stories of near miss events as well. It is good to discuss events that were averted through solid safety practices as well.

Lab safety education, both initial and on-going, are key to helping staff understand the environments in which they work. Safety competencies, drills, and tests are good tools to keep awareness of the lab’s safety issues on the minds of employees every day. Telling safety stories and sharing incidents are other actions that can also reduce safety complacency. Every day our employees come to work, and the potential dangerous possibilities are always there in the lab “vending machine.” Help them to be careful to make the correct selection so they can remain healthy and happy with the career choice they have made.

 

Scungio 1

Dan Scungio, MT(ASCP), SLS, CQA (ASQ) has over 25 years experience as a certified medical technologist. Today he is the Laboratory Safety Officer for Sentara Healthcare, a system of seven hospitals and over 20 laboratories and draw sites in the Tidewater area of Virginia. He is also known as Dan the Lab Safety Man, a lab safety consultant, educator, and trainer.

Laboratory Medicine for Transgender Patients: An Introduction

Welcome to a new series where I’ll explore the role of lab medicine in the care of transgender patients! Many of you may be asking yourself, “Why should I care? I’m in the lab far separated from these dicey patient care issues.” However, the lab plays important roles as the patient moves through the healthcare setting. Everywhere from name confirmation by phlebotomists and before blood transfusion to sex-specific reference intervals, the lab interacts with the healthcare of transgender patients in important ways. With more transgender patients presenting for clinical management, and more clinicians armed with hormone therapy guidelines created and endorsed by the Endocrine Society, it will be expected for laboratory professionals to know how to manage these patients too.

For me, my first encounter with transgender healthcare through the laboratory was during my clinical chemistry rotation when the lab paged me about a very high estradiol value 10 times higher than the upper limit of normal. I found that the patient was a transgender woman taking excessive hormone doses. Their doctor counseled them and persuaded them to stick with their prescribed dose, because the risks of supraphysiologic estrogen is not known. While we were glad the patient didn’t have an estrogen secreting tumor, I wondered how this hormone therapy may affect other aspects of their health and physiology as reflected by lab values.

After a literature review, I found there were few studies that addressed changes in lab values with hormone therapy. Those papers I found had limited numbers of patients, so I decided to find the answers for myself. Subsequently, I (along with two medical students) studied a large number of patients attending transgender specific clinics.  I’ll discuss our findings as a part of this series.

For now, I’ll go over terminology so everyone can be on the same page. Many of us are likely unfamiliar with the experiences of transgender individuals and don’t realize how what appears to be a verbal misstep can be offensive. The first distinction to make is the difference between sex assigned at birth and gender. Sex is assigned at birth to a child, often based on external anatomy. Gender is the set of behaviors and roles that society or culture assigns to a person that ranges from masculine to feminine. However, gender identity is a deeply held internal sense of whether you consider yourself male, female, both or neither. This is distinct from sexual orientation, which one colleague explains: “orientation is who you go to bed with, gender expression is what you go to bed wearing, and gender is who you go to bed as.” When one’s gender identity is concordant with their sex assigned at birth, they are called cisgender; whereas, discordance between sex assigned at birth and gender identity is termed transgender (I think of cis and trans stereochemistry in organic chemistry). The process of using medical or surgical interventions to transition is referred to as gender-affirming hormone therapy or gender-affirming surgery.

The easiest way to address someone whose preferred name doesn’t match their sex in their record is to address them as they appear: use female pronouns if they are dressed as a woman and male pronouns if they are dressed as a man. And if you’re not comfortable with that, a simple “How would you like to be addressed?” is appreciated. I will go into the importance and challenges of legal sex/name and pronouns in the electronic health record in a later discussion.

To round out the topic of terminology, I’d also like to mention a few terms that should be avoided. “Transgendered” adds an unnecessary “-ed” as transgender is already an adjective. It is further confusing, because it makes the word sound past tense (we wouldn’t say “lesbianed,” for example). Rather, a person undergoes gender transition as they accept and express their gender identity through a set of social, physical, medical or legal changes (sometimes call gender affirmation process). Using terms like pre-op/ post-op/ sex change overly emphasizes the role of surgery in the process, and thus gender transition is more inclusive. Similarly, asking for someone’s “real name” overly emphasizes their legal name and there are limited situations where that would be necessary to use. Derogatory terms include tranny, hermaphrodite, or transvestite and shouldn’t be used even when referring to people who are intersex or wear clothes of the opposite sex.

Thanks for making it all the way through this first post, I look forward to hearing any questions you have and exploring this topic together further!

References

  1. Goldstein Z, Corneil TA, Greene DN. When Gender Identity Doesn’t Equal Sex Recorded at Birth: The Role of the Laboratory in Providing Effective Healthcare to the Transgender Community. Clinical Chemistry 2017; 63(8):1342-1352.
  2. Rosendale N, Goldman S, Ortiz GM et al. Acute Clinical Care of Transgender Patients. JAMA Intern Med. Published online August 27, 2018.
  3. Roberts TK, Kraft CS, French D et al. Interpreting laboratory results in transgender patients on hormone therapy. Am J Med. 2014;127(2):159-62.

SoRelle Picture

-Jeff SoRelle, MD is a Molecular Genetic Pathology fellow at the University of Texas Southwestern Medical Center in Dallas, TX. His clinical research interests include understanding how the lab intersects with transgender healthcare and advancing quality in molecular diagnostics.

Up to Date or Up for Debate?

Hello again everyone! Welcome back.

This month I think it’s important to take a step back from clinical pearls, developing our interpersonal skills, and interdisciplinary dynamics and go back to what I started writing about here on Lablogatory: public health and shaping policy. (Sorry, no Transformers, Simpsons, or Star Trek this time.)

Now, you may or may not have heard in recent news that the United States Preventive Services Task Force (USPSTF) updated their long-standing guidelines for screening women for cervical cancer. Normally I wouldn’t file this away under “exciting must-read,” but I was piqued when I also read that ASCP along with the College of American Pathology (CAP), American Society of Cytopathology (ASC), American Society for Colposcopy and Cervical Pathology (ASCCP), the Society of Gynecologic Oncology, the American College of Physicians (ACP), the American Society for Cytotechnology (ASCT), the American Cancer Society (ACS) the Papanicolaou Society of Cytopathology, as well as the American College of Gynecologists (ACOG) and other professional institutions and individuals voiced concerns over the changes to the USPSTF standard.

This is a topic that can be discussed for days, but I’ll do my best to give you the readers’ digest and present the main contentions regarding this standard of patient care and laboratory methodology.

Woah. What’s going on?

Basically, because of some new research and recommendations, the USPSTF—a body which publishes the standard of care for nearly every conceivable aspect of preventive care in the US—rolled back on the algorithms for screening women for HPV and cervical cancer. It all comes down to the utilization of co-testing (doing both Pap smear cytology and HPV testing for certain age demographics) as a point of contention. Under a banner of addressing keywords like “cost” and “harm,” these new recommendations have left clinicians both in and out of the lab in stirrups—sorry, couldn’t resist that one. But don’t worry, I wouldn’t be able to track these changes or even understand them without some sort of visualization. When it comes to recommendations, standards, and guidelines I’m about as proficient as a broken manual diff counter…

cotesting1
Figure 1. These are the guidelines as they stand from each of the major professional organizations concerned with cervical cancer screenings. Dissenting/recommended opinions are highlighted. To the untrained eye this is very unexciting. The bottom line is that the USPSTF no longer recommends co-testing for screening. Source: adapted from UpToDate

Slow down. Explain co-testing and primary testing? What exactly do the old and new recommendations mean?

Okay. When women undergo routine cervical cancer screening they receive Pap smears (cytologic examinations) every three years. This testing has been the standard for a number of years and is adequately sensitive for women up to the age of 30. Often times, these younger women may have slight intraepithelial changes (LGIL) which are considered low grade and remiss on their own. After that age it has become standard practice to add the additional test (while collecting the Pap specimen) of HPV DNA testing. This adds an increased level of sensitivity/specificity and is called co-testing. The new recommendations depart from this co-testing model, citing that there are increased harms (in the form of false positives) which ultimately lead to waste and unnecessary testing for women after the age of 30. Primary testing would mean only screening with HPV DNA assays after 30. According to the National Cancer Institute, all available literature on the subject of HPV and cervical cancer testing adequately demonstrates that co-testing is the best option. A number of studies were compiled to address the harm vs. benefit of Pap and HPV testing. Together, however, these tests decrease the incidence of cervical cancer. New guidelines were made based off mathematical projections and cost-benefit analyses which try and minimize losses for screening. Dr. J. Kim, a public health researcher at Harvard, was integral in contributing models which projected the cost/benefit of changing HPV guidelines. Essentially, the study projected that, when considering “harm” (i.e. colposcopy/false negative) abandoning co-testing changed the mortality rate from 0.3-0.76 per 1000 women with co-testing, to 0.23-0.29 per 1000 women with primary HPV testing. An impressive and significant statistical advantage. However, the total number of unscreened women with mortality rates was between 1-2%. This study was a microsimulation done from historical data within rates of cytologic detection and retrospective testing data on women, projected for a future hypothetical 5 year interval. Fascinated by this study, I tried to reach out to Dr. Kim to discuss limitations in using models and simulations and public health evidence to change practices, but I’m sure she is busy and could not respond in time.

So, to co-test or not to co-test, that’s the question. Right?

In its simplest sense, yes. The major medical professional societies also publish their most current recommendations for practice standards—and the issue is that the USPSTF took a departure from what most of the professional societies recommend regarding co-testing. Late last year, the CAP, ASC, ASCT, ASCP, and the PSC issued a statement under their independent collaboration called the Cytopathology Education and Technology Consortium (or CETC). In this response to the USPSTF guideline changes, they discussed their concerns. Specifically, their objections center around the fact that without co-testing for screening, cancer prevention might be impacted negatively. The CETC claimed that sensitivity is already maximized with previously recommended co-testing guidelines. They also cite that there is only one FDA approved HPV primary screening test available—and not all labs have it! More so, CETC discussed the need to keep morphological testing continuous for women who have histories of Pap smears, the potential to overwhelm colposcopy services for screening all positive HPV patients, and the honest reality that not all clinicians would be compliant with the way the USPSTF recommends testing. The bottom line from this consortium:

  1. Cytology and high-risk HPV co-testing should be kept as the standard screening for women aged 30-65
  2. Primary HPV screening should only be done with validated, FDA approved testing methodologies
  3. HPV screening methods should continue their current schedule until longitudinal data can offer new evidence for changes

So, what’s the current technological climate for how we test for HPV?

Currently, most clinicians do co-testing. The standard for Pap smears utilizes a physical tool to collect epithelial cells from the cervix at vaginal, ectocervical, and endocervical sites. The swabs are prepped on 1-2 slides, fixed with alcohol or other spray cell-preservatives and sent to labs for cytologic examination. The basic Papanicolaou staining procedure uses hematoxylin for nuclear staining, and two cytoplasmic counterstains.  This is essentially a modified H&E stain to clearly visualize morphology.  Staining is rarely done manually and some instruments offer stain/prep combination capability. I couldn’t find too much information on this, but I remember there not being too many official FDA approved prep machines for Pap specimens. Cytotechs and pathologists read the slides and issue sign outs on morphology according to the Bethesda system—very heavy read, don’t bother; essentially it has three main categories of normal, benign changes, and abnormal. According to ASC “for squamous lesions, TBS terminology includes atypical squamous cells of undetermined significance (ASCUS), low grade intraepithelial lesion (LGSIL or LSIL), high grade intraepithelial lesion (HGSIL or HSIL) and squamous cell carcinoma.  Some laboratories also incorporate other terminologies of dysplasia and/or cervical intraepithelial neoplasia (CIN) into their reports.  For glandular lesions, TBS terminology includes atypical glandular cells of undetermined significance (AGUS) and adenocarcinoma.”

As of now FDA approval for HPV primary testing for high-risk strains is limited to the Roche Cobas hrHPV test. I could link you to their website, but you’ll be sold right away. They tout the future of HPV screening is HPV primary testing and to do away with the Pap! Their graphs and figures are impressive (just like their price tag!) and there’s no doubt that sensitivity is something that real-time PCR provides more than cytologic examination. But, as always, more assays will be approved, and advancements will tweak the sensitivity and specificity higher and higher.

Got it. So, technology and lab tests are always advancing, why can’t we make this change?

It’s not so easy to change the method or assay we use to screen or diagnose patients in the lab. If you recall, I talked about how the hospital I’m currently rotating in is leading the region in advancing the new high-sensitivity troponin assays. It’s still a hard sell to many even though the data and projections seem to all point to a green light. But that’s a paradigm shift that involves side-stepping from one immunochemical assay to a more sensitive immunochemical assay. It’s the same stuff, just sharper and with more clinical data to interpret with regards to acute coronary symptoms and clinical risk stratification. Swapping an old car for a new car. This conversation is a bit more complex. The recommendations for cervical cancer screening suggest that we should move away from mostly morphologically-driven, human-based cytology interpretation and move toward PCR-based assays for detection. Literally apples to oranges. We might think we know which one is better right now, but longitudinal studies are the only way to really tease out if this change in practice to improve patient outcomes in the long run.

Where do we go from here?

Ultimately, I think a few things need to happen for this recommendation to become standard practice. First, professional societies in every discipline from gynecology to cytology need to come to an agreement. It remains to be seen whether certain agencies will adopt and recommend the USPSTF guidelines, and statements from groups like CETC reveal a vote of no confidence in this current climate. Ultimately, because of numerous objections (including the ones from ASCP and the CETC) the USPSTF does say that co-testing is still optional between patient and provider, so we’re not really in crisis mode. But what happens when the advancements and the recommendations catch up to our ability to abandon the cytologic contributions of a future useless Dr. Papanicolou? We could probably deal with that when it comes to fruition, but until then we have a real discussion about what “harm” really is. Is colposcopy flat out harm? Or are the false positives that reflex to further testing? Is the current practice a safety-net for populations across socio-economic tiers with varying access to screening in the United States? When compared to other countries, HPV prevention, vaccination, and screening is much more easily facilitated. Is this a contributing factor for our messy guidelines? Will there be more options for FDA approved methodology in the near future? There remain a number of good questions which require examining cross-sections of data and patient outcomes. And, I believe, we may see change soon—but not quite yet.

What are your thoughts? What have you experienced in your lab or clinic? Leave your comments below!

Thank you and see you next month!

References

  1. ASCP One Lab. 2018. ASCP Declares Victory for Patients with Revised USPSTF Cervical Cancer Recommendation. Aug 21, 2018. Accessed Sep 2018: http://labculture.ascp.org/community/news/2018/08/21/ascp-declares-victory-for-patients-with-revised-uspstf-cervical-cancer-recommendation
  2. 2018. Vaccines and Preventable Diseases. HPV Vaccine Recommendations. Centers for Disease Control and Prevention. Atlanta, GA. Accessed Sep 2018. https://www.cdc.gov/vaccines/vpd/hpv/hcp/recommendations.html
  3. 2017. Response to New USPSTF Draft Guidelines for Cervical Cancer Screening. Cytopathology Education and Technology Consortium. Accessed Sep 2018: https://s3.amazonaws.com/ascpcdn/static/ONELab/pdf/2017/CETC+-USPSTF+Letter+10-2-17.PDF
  4. Basu, S. 2013. Complexity in Mathematical Models of Public health: A Guide for Consumers of Models. PLOS, Medicine. Oct 29, 2013. https://doi.org/10.1371/journal.pmed.1001540
  5. Felscher, K. 2018. The science behind new screening guidelines for cervical cancer. An Interview with Dr. J. Kim. Harvard T.H. Chan, School of Public Health. Accessed Sep 2018: https://www.hsph.harvard.edu/news/features/science-behind-new-screening-guidelines-cervical-cancer/
  6. Kim, J. 2017. Screening for Cervical Cancer in Primary Care. Journal of the American Medical Association (JAMA). 2018;320(7):706-714. Doi:10.1001/jama.2017.19872
  7. Lerman, L. 2018. Screening for Cervical Cancer – New Tools and Opportunities. Journal of the American Medical Association (JAMA) – Opinion, Editorial. Vol. 320(7):647-649
  8. Nayar, R. 2017. Primary HPV Cervical Cancer Screening in the United States: Are We Ready? Journal of the American Society of Cytopathology (2017) 7, 50e55
  9. Nelson, R. 2018. USPSTF Updated Recommendations for Cervical Cancer Screening. Medscape. Accessed Sep 2018: https://www.medscape.com/viewarticle/900985#vp_3
  10. 2018. Cervical Cancer Screening (PDQ) Health Professional Version. National Cancer Institute. Accessed Sep 2018: https://www.cancer.gov/types/cervical/hp/cervical-screening-pdq#link/_133_toc
  11. Sawaya, G. 2018. Cervical Cancer Screening—Moving from the Value of Evidence to the Evidence of Value. Journal of the American Medical Association (JAMA), Internal Medicine. doi:10.1001/jamainternmed.2018.4282
  12. Up To Date. 2018. Cervical cancer screening recommendations from United States professional organizations. Accessed Sep 2018: https://www.uptodate.com/contents/image?topicKey=7575&search=&source=outline_link&imageKey=PC%2F82951
  13. 2018. Cervical Cancer: Screening. Recommendation Summary. August 2018. Accessed Sep 2018: https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/cervical-cancer-screening2
  14. USPSTF. 2018. Screening for Cervical Cancer, US Preventive Task Force Recommendation Statement. US Preventive Task Force. Journal of the American Medical Association (JAMA) 2018;320(7):674-686. Doi:10.1001/jama/2018.10897

 

ckanakisheadshot_small

–Constantine E. Kanakis MSc, MLS (ASCP)CM graduated from Loyola University Chicago with a BS in Molecular Biology and Bioethics and then Rush University with an MS in Medical Laboratory Science. He is currently a medical student actively involved in public health and laboratory medicine, conducting clinicals at Bronx-Care Hospital Center in New York City.

History of Generations: GenZ

The newest generation, Generation Z, is born in the 21st century. The oldest are now 18, which means that some have started entering the work force in entry-level positions. This generation is even more comfortable with technology than Millennials, as they grew up with computers, laptops, cellphones, internet and social media all around them.

The older Gen Zers are aware of the financial crisis that occurred, which created a strong focus on saving money. This generation was brought up with a sense of “Stranger Danger” so they are concerned with their own and public safety. They have a strong family orientation and consider themselves global citizens. They are characterized by an entrepreneurial spirit, the idea that anyone can be famous, are open-minded, and care deeply about the environment.

Because of the rising cost of education, many are worried about the price of college and about saving money for their parents. It is a little too early to tell because this generation is still young, but they could have feelings of unsettlement and insecurity due to the state of the economy, environment, and world. They are very loyal, compassionate and independent and have friends around the world, even if they have never traveled abroad themselves.

lotte-small

-Lotte Mulder earned her Master’s of Education from the Harvard Graduate School of Education in 2013, where she focused on Leadership and Group Development. She’s currently working toward a PhD in Organizational Leadership. At ASCP, Lotte designs and facilitates the ASCP Leadership Institute, an online leadership certificate program. She has also built ASCP’s first patient ambassador program, called Patient Champions, which leverages patient stories as they relate to the value of the lab.


 

I think we’re embarking on an incredible generation. I interviewed someone from each of our generations about how they observed, interacted with, learned from the Generation Zs. Here are their thoughts.

The Traditionalist: Ned the Grandpa

As the grandpa of two Gen Z grandsons, Ned found them to have an expanded knowledge base of the entire world. They are sophisticated in their analysis and critical thinking because of their exposure to information that their phones and computers provide them.

Lastly, they value human diversity far more than his own generation.

The Baby-boomer: Donna the Grandma

Donna is a “Grandma Boomer” and finds the Gen Z grandchildren’s vocabulary amazing. She says they are obsessed with the mechanical stuff and are used to doing 2-3 things at the same time. They still love sports, however, it’s like a class that they study. They attend practices but still play with their friends on their computers or phones. However, they “only” text. They don’t talk on the phone.

The Gen Z’s are far more sophisticated than the Boomers, yet they can’t write or spell as well as other generations. They don’t know cursive, and the first question they ask when going somewhere is, “do they have WIFI?” Oh, and “do you have a charger?”

Another Boomer: Susan the Grandma

Susan’s greatest concern was that many high-schoolers were being treated for levels of anxiety. Why? There’s no “turn off switch” with the world. They are almost required to stay tuned to respond or react to friends 24/7. Life is all about them from Instagram to Twitter, and Snapchat and tracking the number of followers.

The GenXer, Kim the Aunt

Her nephews are definitely focused on technology. They do not like talking on the phone and prefer to only text. They have incredible access to information, but they still like to play family games because they value tradition. Her nephews are great travelers and most comfortable with airports, planes and trains, Vs. just cars or bicycles. This is attributed to their expanded world. So what’s their greatest fear? A dead battery!

Maddie the Millennial

Maddie was shocked when she noticed that her sister, who is a Gen Z, was communicating via texting with her friend who was in the same room!

 

Stakenas-small

-Catherine Stakenas, MA, is the Senior Director of Organizational Leadership and Development and Performance Management at ASCP. She is certified in the use and interpretation of 28 self-assessment instruments and has designed and taught masters and doctoral level students.  

Regulatory Inspections: Are You Ready?

Whether your laboratory is accredited by CAP, COLA, JCAHO, or simply adheres to local state and federal CLIA regulations, all laboratories are subject to regular inspections from their accrediting agencies. Normally the thought of an inspection places staff into panic or hiding mode (“Whew, glad I’ll be off that week!”), but if you prepare ahead of time, the inspection process can be an extremely valuable tool to access the overall quality of your laboratory program. Over the next 3 blog posts we’ll review tips on 1) how to prepare before your inspection, 2) what to expect during the inspection itself, and 3) how to address any deficiencies identified by the inspection team.

Part One: The Inspectors Are Coming!

Know the Regulations. As technology evolves and new laboratory methodology is introduced, the requirements for your respective regulatory agencies will be updated as well. Know what version of your checklists or standards you will be getting inspected on, and ensure all staff are familiar with any updates and changes. By engaging all staff in the inspection process from lab assistants up through management, everyone will be aware of what the requirements are and can actively participate to ensure the lab is meeting those requirements.

Focus on Previous Citations. Your inspectors will have access to your previous inspection results, and will be following up on any citations. Ensure that the corrective actions and preventive actions you said you were going to implement have actually gone into effect. For any procedural changes, have documentation (Read & Understand) ready to show that all staff were made aware of and have been trained on the changes. Make sure that those corrections have been sustained and are effective at addressing the noted citation. It’s great to add on new forms to document instrument maintenance – but not if your staff doesn’t have the time to complete them. Again, engage your staff to see what is working, and what needs to be reevaluated.

What is New? New regulatory requirements, new staffing, new instruments, new testing methodologies… These are all key areas that the inspectors will focus on. Have you kept current with your regulatory updates and implemented any necessary changes to address the new requirements? Do you have documented training and competency for each new staff member for each task they are performing? For new instruments, ensure they have been fully validated and correlated to similar instruments prior to being placed into use for patient testing. When adding on new tests, ensure you have a full validation summary with medical director approval and sign off, and that your testing activity menu has been updated as well.

Have a Plan. Depending upon the size and scope of your laboratory, there can be a lot to cover for your inspection preparations. If you wait until your inspection window opens to start getting ready, things will be overlooked or simple “quick fixes” will be implemented instead of finding a long term sustainable solution to any potential issues. Instead, schedule tasks throughout the year to continually review your quality assurance program. Ask management to review 3 – 5 SOPs each month for content (does SOP match the current manufacturer package insert, does SOP match current practice in use), rather than a mass annual sign off. Perform quarterly reviews of your maintenance documentation to ensure all logs have been filled out completely with corrective action documented when appropriate. Utilize calendar reminders to track proficiency testing sample results, and ensure proper follow-up for any non-satisfactory results.

Perform Meaningful Self-Audits. For most regulatory agencies, performing self-audits on your non-inspection years is a requirement. Make this task meaningful by using a fresh set of eyes to review your documents. Ask the hematology staff to inspect the chemistry department; chemistry to inspect urinalysis; urinalysis to inspect microbiology…. You don’t need to understand how to actually perform a specific weekly maintenance task on a particular instrument; you just need to ensure that all those weekly tasks have been documented every 7 days (or less). You don’t need to understand what reagent ‘XYZ’ is used for, you just need to ensure that the vial is properly labeled with an open and expiration date, and that it is not currently expired and still being used. Self-audits should not be punitive; they are meant to catch things that you may be taking for granted are compliant, when in fact they truly are not.

Stay tuned for part 2 coming out next month, where we’ll discuss the inspection process itself and what to expect from the inspection team.

 

Nevins-small

-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.