I don’t think anyone enjoys filling out
the paperwork at a doctor’s office. For transgender individuals, this can be an
experience that ranges from irksome to offensive. Most intake forms don’t allow
for expression of their gender identity. Furthermore, confusion on gender and
sex can create real confusion and healthcare failures in several places that
laboratory medicine encounters a transgender individual.
Arguably the first place the lab
encounters a transgender patient is via the phlebotomist. These professional
collectors of blood must confirm two patient identifiers, which are often name
and date of birth. The “name” used is the legal name. Using a transgender
person’s “dead name” (name given at birth) represents a gender they do not want
to be associated with and can be a very offensive experience. “Isn’t it obvious
that name is not what I look like?”
While names can be legally changed, this
happens with varying difficulty and legal cost in different states. A solution
is to improve training of phlebotomists to explain the necessity of confirming
a legal name so lab results are properly matched to the patient. Additionally,
front-desk intake workers should be similarly trained to interact with
transgender patients when recording demographic information. This can be aided
by electronic health records (EHR) becoming more flexible and inclusive of the
Traditionally, EHR would only include one
field for SEX: M or F.
Several in the laboratory community have
asked how many different gender options should be included? Facebook included
up to 71 options in 2017. That’s a big step up from the 2 traditional EHRs are
The World Professional Association for
Transgender Health (WPATH) executive committee in 2011 outlined the recommended
fields to include in EHR: preferred name, sex assigned at birth, gender, and
pronoun preference. EHRs are evolving and can be flexible depending on the user
requirements. At my program, we use EPIC at 3 different different sites (children’s,
county and university hospitals) and each has a different version.
From what I’ve seen preferred name is an easy addition and would not interfere with
functions of the EHR or Laboratory Information Systems (LIS), which is the
Lab’s version of EHR.
If the field for sex assigned at birth is different from gender, then it would clear up any confusion about whether the
person is transgender and then they should be addressed by the pronouns
matching the gender. While there is a spectrum of genders, only transgender males
and transgender females are of a high enough prevalence to have medically
relevant recommendations. Plus, if a system at least starts here, they could
expand further as necessitated by their population.
EHR could include preferred pronouns, but I haven’t seen this implemented in an EHR
yet. Ideally, you would just use the pronouns that match the intended
appearance of the individual (ma’am to someone wearing a dress, etc.).
Lastly, I think Legal sex should be added to the EHR as well. One of our hospitals
has this and it makes several processes easier such as processing hormone
Legal (or administrative) sex, sex assigned at birth, and gender data fields provide the clearest and simplest picture of a patient
and should be a minimum for labs making recommendations for changes to HER.
Next month I will describe in greater
detail the issues that can arise in the lab when gender or sex are entered
incorrectly in the system for transgender patients and how this can negatively
affect care delivery.
Deutsch MB, Green J, Keatley J, Mayer G, Hastings J, Hall AM, World Professional Association for Transgender Health EMR Working Group. Electronic medical records and the transgender patient: recommendations from the World Professional Association for Transgender Health EMR Working Group. J Am Med Inform Assoc. 2013 Jul-Aug; 20(4):700-3.
Gupta S, Imborek KL, Krasowski MD. Challenges in Transgender Healthcare: The Pathology Perspective. Lab Med. 2016 Aug; 47(3):180-188.
-Jeff SoRelle, MD is a Chief Resident of Pathology 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 improving genetic variant interpretation.
I merrily wait in line at Starbucks for my iced
cappuccino with soy milk, pay $5+ for $0.25 worth of goods poured into my
$14.00 souvenir mug, and walk out the door with my head held high, joyous with
the privileges of conspicuous consumption. My server was super-cheery and the
brief exchange we had was so pleasant—they really love me! I need that high because I am off to the
Department of Motor Vehicles (DMV) for a driving-related task and know–just
know–that there will be an incredibly long line at the end of which sits a
disgruntled government employee who doesn’t care if I show up or not. Their
motivation to help us is non-existent. “Why would anyone ever work here?” I
ask, sipping my delicious beverage.
Today, a doctor called someone in the United
States (US) and told them the biopsy taken from their leg earlier this week has
come back as invasive cancer. A bit distraught and nervous, the patient called
up a nationally recognized cancer center, from which they only live a few
miles, and on the end of the line is a caring, pleasant voice who informs them they
can be seen today! The valet parking is gorgeous, the building is gleaming with
glass and steel, and every face they see as they journey from check-in to
clinic is smiling, compassionate, and sincere. Their nurse and then doctor are
both genuine people with their patient’s best interest in mind, and they
carefully and completely explain what has been found, what needs to be done, and
how they are going to get through all of this together. As they depart, the
receptionist grabs them for a brief moment to return their private insurance
card and waves at them as they depart, adding, “We will see you soon!”
Today, someone in Africa went back to the hospital—an
8-hour journey from their home—where their biopsy was performed a month ago,
hoping to get the result. After several people searched multiple offices and
inquired with several people, the result is found and brought to them, a single
piece of paper. Payment is required before they can receive the biopsy results.
They have brought money with them, which they gathered from three neighbors, their
brother, and by selling some chickens, and pays for the report. They read the
report and, at the bottom, notices that it says additional testing is needed.
Confused, they ask for help and a pathologist comes to find them. Respectfully,
the pathologist explains that additional testing is needed, which is not
available in the hospital despite the pathologist’s strong desire to have it,
but they can send the biopsy to a lab elsewhere to do the testing which will
cost about 3 times what they just paid for the primary report. They happen to
have enough and pay the amount requested. The report will be back in about a
month. Two months later, they have returned to the hospital for the 4th time
and the report is now available. The testing that was done simply confirms that
the primary diagnosis is accurate. They go to the oncology clinic on the same
campus and sit in the waiting area with 3 dozen other people. They sleep at the
clinic overnight outside with about a dozen people. The following afternoon, they
are finally seen and the oncologist reviews the report. He notes that if the
patient had come to the clinic as soon as they had the biopsy result three
months ago, a simple surgery would have cured them of this lesion. But now,
because they waited so long, there is only chemotherapy available which is
expensive and, the oncologist reports, doesn’t actually work very well for this
Before you shed a tear for this terrible situation
(while I sip my cappuccino and a nurse begins someone’s chemotherapy in a
shiny, brightly lit, and expansively windowed infusion unit not far away), we
have to ask ourselves what is really going on? First and foremost, this is an
allegory to make a few points but the situation is repeated over and over again
every day in the US and Africa. However, as a simple, superficial explanation,
the person with cancer in the US is receiving their cancer therapy from
Starbucks and the person in Africa had to go to the DMV.
Cancer care in the United States is almost
entirely in the private sector, dispersed among the 1500 cancer treatment
facilities, of which 70 are comprehensive cancer centers.[i]
Based on the US population, the expected cancer rate, 100% detection, and 240
working days for a given cancer center, there are on average only 5 new
patients per day per cancer center. Is that why one can often get that appointment
right away in a major cancer center or is it really a concierge customer
service effort? A standard private insurance plan for which I pay, for example,
$250 per month and my employer pays $1300 per month is accepted by cancer
centers and results in small co-pays for multiple appointments, which can be
covered with a Flexible Spending Account (FSA) or Health Savings Account (HSA).
On insurance statements after appointments, some of the services received cost
thousands of dollars but the patient portion was only, say, a hundred dollars,
again, which may be paid with FSA/HSA. It’s so great that we have insurance
because the insurance company is bearing the brunt of costs. But are they?
In the United States, 79% of facilities providing
health care are private, a mix of non-profit and for-profit.[ii]
But 64% of all healthcare in the United States is paid for by the US government
through Medicare, Medicaid, the Veterans Administration (VA) system, and Children’s
Health Insurance Program (CHIP).[iii],[iv]Since
almost every cancer care facility is private (or, stated another way, “not
free”), that means that for every one of us at the cancer center getting
treatment, for which we and our employer are paying through insurance, there
are two people getting the same treatment at the same high-level quality of
care for which the government is paying. Those other deductions from our
paychecks for Medicare and Medicaid (which everyone pays, regardless of how
old, as long as they are employed and regardless of their own health insurance
plan) are going towards the 64% coverage. The point is not that the US
healthcare system is expensive. The
point is that there is a lot of revenue and resource being put into the
healthcare system and, thus, there is a high-quality product or experience that
If we look at any low GINI index country and
compare their GDP with the US GPD and compare their spending on healthcare as a
% of GDP, we don’t even need to do the math to see that there is very little
money per person available in the system for any type of healthcare. The
challenge in low-resourced settings (by which it is meant low-resourced
patients in low-resources locations) is both a lack of funding available to
provide healthcare services along with a lack of “stuff” to provide those
services. We can invoke the law of supply and demand to try and argue that the
people can rise up and demand more healthcare facilities and “someone” will
meet that supply. In the US, this results in the Starbucks model. In a
low-resourced setting who has the incentive to meet that supply? Where does the
government get the money from to create such a system? What private corporation
is going to start a healthcare program that provides universal coverage
regardless of what you can pay?
The answer is really quite simple. This model of
healthcare is insufficient for cancer and isn’t going to work for all patients.
Moreover, the Starbucks model is not really applicable, sustainable, nor
equitable. When we go to Starbucks for their coffee, to some degree, our choice
of Starbucks is because of the a) flavor of the coffee, b) cost of the coffee,
c) perception of the coffee, and/or d) convenience of the coffee. We could
always choose Dunkin’, Peet’s, Tim Horton’s (maybe let’s not go there for this
analogy), or Green Mountain coffee at a different location. There is variation
in pricing and convenience. There is variation in the condiments we can use to
doctor our coffee. An economy and series of markets exist which allow Starbucks
to gather resources from dozens of other companies to provide your coffee. But,
ultimately, we are all buying coffee which has caffeine which has a desired
effect. We can go to a free AA meeting or to a soup kitchen and get some pretty
basic coffee if we don’t have the money to pay. The point is we have choices
and we can pay a high price, a low price, or no price and we get coffee.
The Starbucks model does work for a certain sector
of the population but not everyone. Since vast majority of cancer care in the
US is private, the Starbucks model falls down because we don’t actually have
any free options as a society and “low-cost healthcare” is not typically
appealing to most Americans with cancer because they have their mortality at
stake (no one wants cancer nor does anyone want to die from cancer). In fact,
desperation in the face of cancer is what makes the US one of the only places
in the developed world where people go bankrupt trying to be treated for
cancer. The ultimate inequity is that cancer care is “pay to play” in the US
and there essentially aren’t safety nets for any populations that can’t pay
(homeless) or are living below a certain income threshold (i.e., the ~10% of
Americans without healthcare plus a large percentage with insufficient
Please remember, these are human beings and they
didn’t choose to get cancer (there is no demand for cancer… there is only
demand for cancer care!). Since they didn’t have a choice in the disease they
have to be burdened with, why is there an expectation that they should pay for
the treatment? Moreover, if a patient has a stage I cancer, easily surgically
removed and cured vs. a Stage III cancer requiring months of various therapies
at a very high cost, how do we ethically explain an increased cost for a worst
state of disease? It’s really an inverse quality spectrum and we make patients
pay more for getting a lot less. We pay for insurance in case we ever do get
cancer (or other major disease). It’s a risk reduction or risk aversion
pre-payment. Like we do with our car or our house or our boat. Those last three
things we choose to have (and are luxuries). We don’t get to choose to have
health. It’s just an inherent part of being human so holding someone
accountable for it because they didn’t have the resources to “prepare for the
worst” is really the wrong attitude. Our healthcare system isn’t perfect but
there are gaps that could be easily filled if resources are allocated
efficiently to meet the whole populations needs—that’s the benefit of having a
large resource supply into the system. We just have to find the operational
efficiency to make the costs work.
However, when we remove the luxuries of insurance, Medicare, and Medicaid and other payments systems from the health sector or, worse, simply assume the government’s role is to provide healthcare 100% free to all citizens in a resource-limited or resource-constrained setting, we suddenly have an untenable situation. The economy and tax-base are not there to create the resources. We find overworked, underpaid, and undersupplied medical staff working in crowded conditions. For single entity care (e.g., HIV, tuberculosis, malaria), vertical programs have made great strides in combatting these diseases even in some of the poorest countries in the world. But cancer is anything but simple with the complexity of cross-discipline collaboration, spectrum of disease, range of treatments, and inherent costs creating huge gaps in the delivery of cancer care. Economic and physical infrastructure for the provision of care is what is needed to meet this challenge. Our current Starbucks model in the US would be extremely difficult to replicate in a low-resourced setting due to the lack of infrastructure. However, when this infrastructure is assessed, planned for, and implemented, cancer care can be delivered in these settings at a significantly lower cost per patient. Adding infrastructure implementation high-quality private facilities and public-private partnerships creates a way forward to pump resources into the system and insure that no patient is left behind. To round out this allegory, AAA locations (a commercial car-servicing company) in various parts of the US allow one to renew your driver’s license with them, rather than the DMV. I did this once, it was VERY fast, friendly, and efficient. This type of public-private partnership worked for me and I believe it will work for cancer if we are willing to try.
[ii] “Fast Facts on US Hospitals”.
Aha.org. Retrieved December 1, 2016.
Himmelstein DU, Woolhandler S (March 2016). “The Current and Projected
Taxpayer Shares of US Health Costs”. American Journal of Public Health.
106 (3): 449–52. doi:10.2105/AJPH.2015.302997. PMC 4880216. PMID 26794173.
Government’s share of overall health spending was 64% of national health
expenditures in 2013
Leonard K (January 22, 2016). “Could Universal Health Care Save U.S.
Taxpayers Money?”. U.S. News & World Report. Retrieved July 12, 2016.
-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.
A 44 year old male with history of cocaine use presented with 1 year history of headache and progressive frontal lobe syndrome, including symptoms like apathy, personality changes, lack of ability to plan, poor working memory for verbal information or spatial information, Broca aphasia, disinhibition, emotional lability, etc. CT scan found extensive destruction of osteocartilaginous structures of the nasal cavity and MRI showed extensive edema of the frontal lobe. Biopsy showed chronic inflammation but negative for granulomatous inflammation. Patient’s CSF laboratory analysis was normal but ANCA was tested positive, in a P-ANCA pattern without MPO detectable. Patient was diagnosed as CIMDL. After stopping cocaine use, patient was doing better but still has mild frontal lobe syndrome.
Anti-neutrophil cytoplasmic antibody (ANCA) are a group of
autoantibodies that directed toward antigens expressed mainly in neutrophil
granulocytes, such as proteinase 3 (RP3) and myeloperoxidase (MPO). The
presence of ANCA is mainly associated with a distinct form of small vessel
vasculitis, known as ANCA-associated vasculitis, but is also detected in other
disease, like autoimmune hepatitis, primary sclerosing cholangitis, ulcerative
colitis, and other chronic inflammatory disease. The gold standard laboratory
method to screen ANCA is indirect immunofluorescence assay (IFA or IIF), which qualitatively
capture antibodies in serum/or plasma bound to fixed human neutrophil
Two form of ANCA-associated vasculitis, granulomatous with
polyangiitis (GPA) and eosinophilic granulomatous with polyangiitis (EGPA), are
systemic diseases that commonly associated with necrotizing granulomatous
vasculitis. GPA has a primary involvement of the upper and lower respiratory
tract and kidney. Autoantibodies to PR3 are found in 90% of active GPA cases,
which generates a cytoplasmic-ANCA (C-ANCA) pattern on ANCA IFA test. EGPA is a
rare form of systemic necrotizing vasculitis characterized by asthma and
eosinophilia. A perinuclear-ANCA (P-ANCA) IFA pattern directing towards MPO
antibody are often seen in EGPA cases.
Both GPA and EGPA may also present with sinonasal
involvement, causing non-infectious inflammatory lesions of the sinonasal
tract. Sinonasal inflammatory disease can also result from bacterial and fungal
infections, or other non-infectious process, such as sarcoidosis,
polychondritis, or obstruction. ANCA is detected in the majority of GPA and
EGPA case, therefore it provides useful information in differential diagnosis
of sinonasal inflammatory disease. Both GPA and EGPA are autoimmune diseases,
corticosteroids and immunosuppressive agents are effective treatment.
Sinonasal inflammation can also been seen in a subset of
patients with cocaine abuse, who normally present with midline destructive
lesions, known as cocaine-induced midline destruction lesions (CIMDL). Long-term
cocaine use has been associated with ischemia of mucosal tissue, cartilage and
bone, and cocaine abuser using intranasal inhalation route can have midline
deformity and septal perforation. Interestingly, ANCA are also found in a large
portion of CIMDL, and in contrast to GPA or EGPA, ANCA in CIMDL are primarily
directed against neutrophil elastase, generate a P-ANCA or atypical P-ANCA
pattern, without detection of MPO. Therefore, ANCA serology testing could help
the differentiation between CIMDL and GPA although these two can overlap
clinically and histopathologically. Also, CIMDL does not respond well to
immunosuppressive therapy and only consistent removal of stimuli (cocaine) can
halt the disease process.
Montone KT. Differential Diagnosis of Necrotizing Sinonasal Lesions. Arch Pathol Lab Med. 2015 Dec;139(12):1508-14. doi: 10.5858/arpa.2015-0165-RA.
Trimarchi M, Bussi M, Sinico RA, Meroni P, Specks U. Cocaine-induced midline destructive lesions – an autoimmune disease? Autoimmun Rev. 2013 Feb;12(4):496-500. doi: 10.1016/j.autrev.2012.08.009. Epub 2012 Aug 24.
Madani G, Beale TJ. Sinonasal inflammatory disease. Semin Ultrasound CT MR. 2009 Feb;30(1):17-24.
Timothy R. Helliwell Non-infectious Inflammatory Lesions of the Sinonasal Tract. Head Neck Pathol. 2016 Mar; 10(1): 32–39.
-Xin Yi, PhD, DABCC, FACB, is a board-certified clinical chemist,
currently serving as the Co-director of Clinical Chemistry at Houston
Methodist Hospital in Houston, TX and an Assistant Professor of Clinical
Pathology and Laboratory Medicine at Weill Cornell Medical College.
Last month, I wrote about some
projects I did while rotating through the pathology program at Danbury
Hospital in Connecticut. This month I’m in a more clinical setting with a
hematology/oncology clerkship at Northwell’s Staten Island University Hospital.
But, over the past few months of rotations (and arguably a lot longer before
medical school) I’ve been noticing a part of laboratory medicine which often
intersects with our clinical colleagues at the bedside. I’ve told you about the
pitfalls and successes in the relationships
between surgeons and anatomic pathologists before, where frozen sections
are critical and time is of the essence. And we’ve all seen collaboration
between the bench and bedside before—think microbiology and infectious disease,
blood bank and literally everyone, etc. Still, one collaborative effort sort of
happens behind the shadows, behind phone calls and lab reports, and sometimes
with no communication at all! So, what kind of vigilante medicine am I talking
about? Who is this Batman of medicine? It’s just our friends in hematology.
When you’re working the hematology bench in the lab, it’s
pretty commonplace for a physician on a hematology service to call and ask for
a peripheral smear to review. Many times, it’s for the purpose of teaching
residents, fellows, or medical students but more often than not it’s a
confirmatory exercise. See, when that hematologist asks to review a slide,
she’s probably coming down to the lab to look at the morphology of red cells
and white cells to help in their differential diagnosis. They might have a
patient with a suspected thalassemia or hemoglobinopathy and, before starting
the full work up of lab tests, just want to see if there are any RBC morphology
traits or target cells that stand out. Thrombocytopenia? Let’s make sure
there’s no platelet clumping. Maybe they’ve got a patient with some kind of
liver or kidney pathology and are on the hunt for acantho- or echinocytes. Or
better yet, someone went hiking, there’s an infectious etiology on their
differential—let’s go hunting for babesia, malaria, oh or even erlichia!
I know what you’re thinking. Wait—that’s our job as
medical laboratory scientists; our literal job. Our instruments, that we
validate, and correlate, and make sure work fantastically give us flags. We
investigate those flags and look at smears ourselves! We collaborate with other
lab techs, and with our pathologist colleagues and send out final lab results
with all kinds of helpful information: including platelet clumping,
microorganisms, RBC and WBC morphology, and loads more. What gives?
Hold on to your lab coats. I’ll get there in a minute.
Slide review and differential training in medical school
[This section intentionally left blank]
A Differential, Differential
So let me address the issue I brought up: why do
hematologists come down to the lab to look at the slides themselves, when
perfectly capable BOC certified, degree-holding medical laboratory scientists
and pathologists sign out validated differentials? It might not happen this way
at all hospitals, but I think the answer is a simple two-part problem.
First, as with the many things I’ve learned in medical
school, one of the lab-centric pieces of information that is well understood is
that, well, no one really knows what the lab does and how it operates.
Virtually nobody knows the depth and breadth of the testing that pathologists
manage, let alone the scientific precision and accuracy that instrument
validation requires. Learning that MLS techs are certified, can hold graduate
degrees, and even do their own research is often surprising to most of our
clinical colleagues. And—I will tell you for a fact—that pathology and
laboratory testing methodology is not covered in medical school the way you
might think. Pathology is more of a class of distinguishing the identifying
details of a disease, not understanding the interdisciplinary diagnostic
teamwork that goes into those CBC index results on a computer screen on the
Second, hematologists are specialists just like any other
practicing clinician. They know their stuff! They manage patient diagnosis,
treatment, and follow-up with the most up to date literature, national cancer
guidelines, and anything else available to better their patients’ outcomes. Despite
the notes in the CBC results that there are numerous macrocytes with
hypersegmented neutrophils, or 3+ schistocytes reported in a manual
differential—seeing is believing. It helps to see the slide yourself and get a
feel for the disease “state” with your own eyes. Moreso, it could be a learning
opportunity. It’s well within a clinicians’ scope to come down and look at a
peripheral smear, I actually encourage it. But it should come with a few
caveats…I’ll get to those too…
One of the places I was proud to hang my lab coat was
actually my first job as an assistant lab technician in the blood bank at Rush
University Medical Center in Chicago. Before I got my MLS and way before grad
school or med school, I was a blood bank “expediter.” Super fancy title, but
all I did was make sure specimens were logged in and blood products were up to
par with labels on their way out. Clerical but critical! (Let me have this,
please…haha) Anyway, part of the culture at that hospital has stayed with me
all these years. I’ve talked before about culture and the
way it permeates an institution’s practice like at the Mayo Clinic, but for
my first foray into clinical work their acronym was clutch: I CARE.
I for innovation
C for collaboration
A for accountability
R for respect and
E for excellence
Why am I telling you this? No, there are no royalties. I
just think it’s an easy way to remind ourselves about the meaning of
interdisciplinary medicine and they way we should work together across
specialties, and from bench to bedside. When we incorporate those values into
our work for the purpose of improving patient care and outcomes, everyone wins.
In this case, effective utilization of resources tells us that peripheral slide
review means different things to different people. In the setting of
hematologic work-ups, flags and review at the bench can signal something to the
clinician which could spark a conversation with the pathologist. All parts
contributing to a whole of patient care. Vigilante medicine is bad news.
Collaboration is key.
One place I was lucky enough to be a part of this
interdisciplinary collaboration was Swedish Covenant Hospital. One of the
hematology physicians would routinely call me and ask to look as peripheral
smears down in the lab, often as a group with med students, residents, and
fellows. I’d throw the image of his patients’ slides on a large flat screen and
go over what certain traits meant with regard to morphology and identification
from the lab setting. Dr. Cilley would add what this all meant clinically and
discuss treatment algorithms and next steps. That was collaboration at it’s
finest: lab tech working with pathologists, clinicians working with the lab,
and patient’s benefiting from all of it.
Teamwork makes the dream work
About those caveats for collaboration I mentioned earlier…
Let me put it briefly: it’s well within the scope of a clinician to come over
to the laboratory and get some information on their patient’s lab
results/testing. But why not consider the following:
If a physician calls to review a smear, offer
to go over it with them. Likewise, to our clinical friends: if you go to the
lab for a slide don’t be batman—ask the tech what they think!
Experienced techs are one of the hospital’s most valuable resources. Some
folks I’ve worked with have been looking at slides longer than I’ve been using
my eyes at all! They’ll save you and your residents the time when those
terrifying intracellular microorganisms are really just overlying platelets. I
mean, they’ve got a cute halo.
If you need help, just ask. This applies to
Talking with the tech about the slide is great start, but there’s more
resources in the lab than most people know what to do with! Clinical
physicians: check the shelves around the hematology microscope. Stuck on
something? Find a CAP atlas or a proficiency survey booklet guide. Easy to
read. Techs and pathologists: have someone who constantly comes down for slide
review despite your immaculate and detailed SOPs on CBC results reporting? Have
a quick chat about the work that goes into resulting those diffs—you might even
improve your heme TAT, who knows?
If it’s well within the right of a physician
to leave the unit and see a patient’s slide, logic says that maybe, just maybe,
it should be okay for a pathologist to leave the lab and see a patient at the
are full of never-ending rounding white coats, all asking patients questions,
and all contributing specialty notes to their charts. But its not only
to prevent patients from getting a decent nap. We’re all parts of a large
interdisciplinary patient team. A recent Medscape survey found that somewhere
around 3% of pathologists see patients, routinely! Got an interesting case in
the lab, someone who’s part of lots of tumor boards, someone with an
interesting case to write up, or even someone who nobody knows exactly what’s
going on with? Try walking over to 4 south and have a conversation with Mr.
Jones; it might help. At least he’ll know how many people are working on his
The bottom line: we’re in this together, and like the flag
on the ASCP ship says, we’re Stronger Together. Innovation,
collaboration, accountability, respect, and excellence are—and should be—simple
cornerstones of clinical medicine that translate across every discipline. When
we share information and expertise, everyone gets better at what they do.
Thanks for reading!
See you next time!
–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.
In previous blog posts we discussed some hints and tips for how to survive when your lab is being inspected. Today we get to flip things around and let you be the inspector. Whether it’s an internal audit of your own laboratory, or an external inspection of a peer laboratory, we’ll discuss some ways to help keep you on track to cover the most important aspects of the overall testing process in a limited amount of time.
For external audit preparation, the CAP has a wonderful training program that all volunteer inspectors are required to take prior to participating in an inspection. For labs that are not CAP accredited, they still have helpful information on their website that is free and open to all: https://www.cap.org/laboratory-improvement/accreditation/inspector-training. CLSI document QMS15-A (Assessments: Laboratory Internal Audit Program; Approved Guideline) is another great resource to use when planning your audit.
The primary role of an auditor is to review policies, processes, and procedures to identify any inconsistencies (does your SOP match the manufacturer recommendations, and is staff following the SOP as written). Audits should focus on collecting objective evidence and facts, rather than subjective opinions. For example, staff failing to document required weekly maintenance tasks, as opposed to an auditor simply not liking the particular form the tasks are being documented on.
Define the Objective of the Audit
Laboratory leadership should be involved in the planning process to help define the scope and expected goal of performing the audit. This can range from an overall assessment of general laboratory quality and safety, to a more directed and focused audit on either a single department, instrument/test, or test process (specimen collection, physician notification of critical values, etc). The format for the audit findings should also be discussed – will the site require a formal, written report outlining all observations detected, or will a simple informal summation discussion be sufficient?
Draft a Schedule for the Audit
Once the scope of the audit is defined, a tentative schedule should be created so all staff involved in the audit process are aware and available to participate. If the audit will encompass multiple departments and all phases of testing (pre-analytic, analytic, post-analytic), it may be necessary to split the audit up over multiple days, or to recruit multiple auditors. The frequency of audits will depend on the perceived risk to quality based on previous findings or complaints received, but at a minimum should be completed annually.
Prepare for the Audit
Reach out to the local management team of the site being audited for help in gathering the information you’ll need to prepare. This can include things such as a testing activity menu, list of new instrumentation or new test validation studies, employee roster if personnel and competency records will be reviewed, and copies of previous audit/inspection results to check for corrective action implementation and sustainability. Review the information provided, and use it as a guide for where you feel your efforts should be focused on based on highest risk.
Utilize a Patient Tracer
Ask the site to pull all related records and reports for a particular patient sample by choosing a date, and specifying any particular characteristics for the specimen that you want to follow (such as age of the patient, sex, or focusing on abnormal/critical results). By asking the sites to prepare a patient tracer ahead of time, this will reduce the amount of time spent waiting and digging for specific files or log sheets as they are already organized and ready when you walk in for the audit. Tracers should adhere to the defined scope/objective of the audit, and will help you follow the path of a specimen through the entire process from pre-analytical, analytical, and finally post-analytical phases.
Pre-analytical: Include any specimen collection instructions or a printout/photocopy from the test directory for each test requested. This information should be compared to the information within the applicable SOPs to ensure they match and are both current and accurate. Physician orders can be included to confirm that the correct test was ordered and performed based on what was requested by the clinician.
Analytical: Copies of the related SOPs for the test being reviewed should be included. Ensure the SOPs have all required elements, including a current, valid signature of approval from the medical director. Instrument QC and maintenance logs for the day of testing, calibration records, and patient correlation studies should also be reviewed, along with the reagent lot-lot validation performed. When available, copies of the actual instrument printouts should be included to check for accuracy in result transcription. Training and competency records for the staff who performed any handling or testing of the specimens in question may also be reviewed.
Post-analytical: Check for supervisory review of patient log sheets and QC records, along with appropriate corrective actions documented as applicable. Review the patient results in the same format that is seen by the physician: confirm reference ranges and units of measure are accurate, interpretive notes are valid and appropriate, test methodology is stated when applicable, abnormal values are flagged, and confirm result transcription accuracy from the original instrument printout. Proficiency testing results should be reviewed for any unsuccessful events to confirm sustainability of corrective actions.
Conduct the Audit
Perform an objective review of the documents provided, along with any affiliated records and logs based on the scope of the audit (temperature logs, reagent inventory records, decontamination records, etc). As with an official inspection, be transparent with the staff as issues are identified so they can have an opportunity to clarify any confusion, or locate additional records that may be missing or incomplete. Document any discrepancies or possible issues noted, as well as any good lab practices observed that should be celebrated. When logging your findings, be specific and provide as much details as possible so the staff can quickly identify what was found and make the needed corrections (SOP numbers, dates, instrument serial numbers, etc).
In addition to reviewing documentation, perform a direct observation of the staff doing specific tasks. Are they following the steps outlined in their procedures, or are deviations noted? Rather than a formal interview, ask the staff to explain what they are doing, or why they are performing certain steps in a particular order. Again, the audit is not meant to be punitive or to ‘catch someone in the act’, but rather to help identify areas for improvement or clarification so that testing processes can be improved and standardized among all staff members. Asking open ended questions will provide more information than directed ones. For example, “Show me how you would access testing instructions if your computer network was down” as opposed to “Where are the paper versions of your SOPs?”
Prepare an Audit Report
The audit findings should be summarized for the site based on the format agreed upon during the initial planning stage (written report, verbal discussion). Whenever possible, similar findings should be grouped together so the location can identify systemic problems that need to be addressed on a more global level (expired reagents found in multiple departments, staff failing to utilize appropriate PPE in multiple departments, etc). Depending on the number and severity of the issues identified, sites may prefer to have the observations grouped by department as well for easy assignment of follow-up action items to the department leaders. Issues should also be ranked by risk severity so that the site knows where to focus their improvement efforts first: 1) Patient care and employee safety issues; 2) Regulatory compliance gaps; 3) Recommendations for improved overall good laboratory practice.
Implement Corrective Actions
Any issues identified during the audit should be assigned to a specific person for follow-up, along with an anticipated date of completion. Perform a proper root cause analysis to identify why the issue happened, and then decide how to correct it and prevent it from happening again. Depending on the scope of the audit, the audit team members may be involved with these tasks, or this may fall to the sole responsibility of the management team being inspected.
Evaluate the Effectiveness of the Audit
The utility of the audits will depend greatly on the commitment of laboratory leadership to both implement, and sustain, effective corrective actions based on the quality gaps identified. This can be assessed by the overall level of compliance with the regulations being checked, and comparing the results of this audit to previous and subsequent ones to hopefully show a downward trend in potential citations detected. The audit team should obtain feedback on the audit process to assess the inspected lab’s overall satisfaction with the program, the amount of support offered to the inspected laboratory, effectiveness of communication between the teams, and any potential areas for improvement in the process.
Performing internal audits is a great way to meet regulatory, accreditation, and customer requirements. It allows you an opportunity to identify non-conformances and risks that can affect both quality, and patient/employee safety. By performing regularly scheduled internal audits, not only will staff members become more experienced and better prepared for the official external inspections from regulatory and accrediting agencies, but the laboratory will move from a culture of reactive, corrective actions to that of a proactive model of continual improvements.
-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.
When a complete
blood count (CBC) and differential is ordered by a physician, most labs today
have instrumentation capable of performing an automated differential. Depending
on the instrument results and flags, we may need to perform a scan, review of
the slide, or a manual differential. However, the definition of a manual
differential today may be a bit different than the historical definition. A
typical manual differential, when I first started working as a technologist,
consisted of counting and differentiating 100 white blood cells under a
microscope, and performing a red blood cell morphology along with a platelet
estimate. Today, the 3 components of the manual differential have not changed,
but more and more labs are using an
automated digital counting device, such as CellaVision. Whether counting cells
under the microscope or scanning and verifying or reclassifying cells in CellaVision,
it is important to always address all 3 parts of the manual review.
CBC has flagged that abnormal RBC morphology may be present, a peripheral blood
smear should be reviewed. Reporting the red blood cell (RBC) morphology is an
important component of a differential. Evaluation and interpretation of RBC
morphology may provide the physician with important diagnostic information
regarding the underlying cause of a variety of disorders, including anemia and
systemic disease. Therefore, it is important to be able to accurately recognize and
identify RBC morphologic abnormalities.
Red blood cell
morphology can be subjective, and therefore inconsistent. Therefore, Laboratories
must have training and competency programs as well as procedures which dictate how they will report
RBC morphology. Some labs use a numbering system, 1+, 2+, 3+, and others
‘few’, moderate’ or ‘many’. Some morphological, such as rouleaux, can just be
reported as present, with no quantified. Any method is acceptable, as long as
there is consistency in reporting.
RBC morphology, these semi-quantitative
report formats for should be based on clinical significance. Some RBC
morphologies and inclusions are clinically significant,even when
they are present in very low numbers. Sickle cells are one of these
abnormalities that are significant even if only seen in very small numbers.
Malaria or other parasites are clinically significant in any number. Fragmented
cells such as schistocytes and helmet cells should also be noted if seen in any
number. Other abnormalities which can be clinically significant in very low
numbers are polychromasia, spherocytes and teardrop cells.
There are many
other abnormal RBC morphologies which are only clinically significant if seen
in larger numbers. Laboratories may choose to only report the presence of
ovalocytes, target cells, burr cells, macrocytes, microcytes or hypochromia
when greater than a defined percentage of cells exhibit these morphologies.
Other laboratories choose to not report macrocytes, microcytes and hypochromia
at all, instead relying on the physician to use the RBC indicies for their
indication. The 2 most important things to remember, whatever your procedures
are, is to be consistent, and not to ignore the:RBC morphology.
addition to performing RBC morphology, a manual differential also requires
platelet examination. A smear should be examined for a platelet estimate and
abnormalities. This is particularly important when platelet clumps or an
abnormal platelet scattergram are flagged on the CBC. If an instrument uses optical platelet
counts, large platelets can be missed. A fluorescent platelet count (PLT-F) ,
performed on Sysmex analyzers, will stain only platelets and give an accurate platelet
count. The fluorescent count eliminates interferences seen with other methods.
However, even when reporting a PLT-F, it may still required to review the smear
for a platelet estimate, particularly with a very low count, or with clumped
platelet flags. Clumped platelets are not an uncommon phenomenon, and an
accurate platelet count can not be reported if significant clumping is present.
The presence of giant platelets or hypogranular platelets, seen on the
slide, can also aid the physician in
diagnosis or patient management.
CellaVision users have the added benefit of automation which simplifies the process of performing manual differentials. The system automatically locates and takes digital images of cells, including white blood cells, red blood cells and platelets.This simplifies the process of performing a manual differential. White blood cells are pre-classified, RBC images are provided, and platelet images allow platelet estimates to be performed easily. The new advanced RBC application software can pre-classify RBCs. This makes it even easier than before to perform reliable, standardized RBC morphology. (Watch for my next Hematology blog about the new RBC software!)
disorders or abnormalities often involve characteristic changes to RBC
morphology “Assessment of RBC morphology can be the best tool for
laboratory hematology professionals to recommend clinical and laboratory follow‐up in a patient with anemia and to select the
right tests for definitive diagnosis.”1 Too
often, I have seen technologists perform a manual differential and either
superficially skim over the RBC and platelet components, or totally forget
them. Don’t forget
your RBC morphology and platelet estimate and morphology! With today’s
automated differential and autovalidation, 75-85% of CBCs are autovalidated.
This allows us to spend quality time on those manual reviews that need to be
done. Be sure to spend your time thoroughly reviewing the slides. A scan, slide
review or manual differential, whether done under the scope of with CellaVision,tells
the physician that we have looked at the slide or cells, which must include all
3 parts of manual review… WBCs , RBCs and platelets. Don’t sign it out until
J. Ford, Red Blood Cell Morphology.
International Journal of Laboratory Hematology. 2013
-Becky Socha, MS, MLS(ASCP)CM BB CM graduated from Merrimack College in N. Andover, Massachusetts with a BS in Medical Technology and completed her MS in Clinical Laboratory Sciences at the University of Massachusetts, Lowell. She has worked as a Medical Technologist for over 30 years. She’s worked in all areas of the clinical laboratory, but has a special interest in Hematology and Blood Banking. When she’s not busy being a mad scientist, she can be found outside riding her bicycle.