There are multiple types of risk assessments required when
managing a laboratory safety program. OSHA’s Bloodborne and Airborne pathogens
standards require assessing the risk of employees’ exposure to particular lab
hazards. Risk assessments can be used to determine whether or not to add an
emergency eyewash station, and all lab chemicals need to be assessed for the
hazards they pose. These are just some assessments that are needed, and there
are particular steps to take when performing them. But what about the lab
emergency management plan? Should the lab perform a risk assessment for that?
The answer is yes, although the terminology used may be different. To prepare a
disaster readiness plan for the lab, the risk assessment that is needed is
known as a Hazard Vulnerability Analysis (HVA).
The Centers for Medicare & Medicaid Services (CMS)
requires that all healthcare facilities use an “all-hazards” approach when
considering emergency preparedness and planning. While some laboratories may be
included with the facility-wide disaster plan, the lab should absolutely have
its own plan with specific instructions that apply directly to the department.
That means the lab should also consider an all-hazards approach.
It may seem daunting to try to consider every possible
disaster that could occur in the department, but that is not exactly what the
directive from CMS dictates. An all-hazards approach means that emergency plans
should be scalable or flexible so that it can be used for many types of
disasters. The plan should focus on the lab’s ability to continue to offer
services, especially those deemed critical, as a disaster situation unfolds.
The first step to the plan creation is the risk assessment-
the Hazard Vulnerability Analysis. The HVA can be a table that lists all of the
potential types of disaster; natural, man-made, facility-specific, etc. List as
many as you can think of, and be sure to include specific disasters that may be
particular to your locale (earthquakes, blizzards, etc.). Rate each disaster
type by probability, severity of impact, and level of readiness of the lab to
respond. Using that data, you can calculate the risk percentage for each
One other requirement imposed by CMS is that facilities must
include emerging infectious diseases as one potential type of hazard class.
With the advent of particular diseases in the past years like Ebola, Zika, and
certain influenza types, it is important to consider how an outbreak would
affect lab operations and staffing. The risk level of infectious diseases may
vary as incidents and outbreaks occur in particular geographic regions or if
The HVA should be reviewed and updated as necessary each
year. Things change that can affect what is on your HVA list. The addition of a
nearby airport might make you consider adding airline disaster to the HVA. A
change in weather patterns could occur as well. In 2011 a surprise earthquake
in Virginia made state facilities re-look at their HVA list of possible emergency
situations. Also, the actual list of disasters might not change, but there may
be a change in the potential of a particular incident occurring.
If your lab or facility has not yet performed the HVA risk
assessment, there is no need to panic. There are several model HVA tools
available on line that can be used. As with any risk assessment, be sure to
keep documentation readily available, review it each year, and make sure staff
are trained about not only the HVA process, but in how to use the emergency
management plan as well. There is a great amount of work that can go into
preparing for a disaster, and training and drills for your staff will help to
facilitate a smoother activation of the plan when the real emergency situation
–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.
For most people working in laboratory
medicine, their first encounter with transgender patients likely arose from an
issue involving the Electronic Health Record (HER). For me, I was called into
the reference lab, because an abnormally high estradiol result was found by the
referring lab. They were concerned this might be coming from a hormone
secreting tumor, but inspection of the patient’s record revealed they had been
taking higher than recommended doses of their feminizing hormones.
Today I will share stories from issues
that arise in EMR when gender doesn’t equal sex. While these may not
specifically happen to all of you, I hope they can be informative or help you
anticipate future problems.
Transgender issues came up at one of our
institutions when providers were getting dozens of messages in their in-baskets
about new flagged lab results for multiple patients. This is very annoying,
because they have to address each of these messages or they are out of
compliance with the hospital. An investigation revealed that all of the
patients involved were transgender patients. In order to get estradiol, sold as
oral contraception pills, the pharmacy had to administratively change their sex
in the EHR for approval, then change it back.
This moved their corresponding reference
ranges out of sync, which triggered a new results flag. Changing the sex back
triggered other flags and more messages. This was finally resolved after a
committee was convened and several meetings occurred, but no one would have
anticipated this type of issue arising from a simple action to get patients
Sometimes transgender patients have their
sex changed legally. If an EHR only includes one sex entry instead of gender
and sex assigned at birth, then certain lab errors may prevent processing of
important samples. The pregnancy test for a transgender man could be
auto-rejected. This can be an issue even for providers in front of the patient
as was recently reported in a case to the NEJM about a transman who was
mistaken as obese instead of pregnant and miscarried their child.
Similarly, a prostate biopsy from a
transgender woman could be auto-rejected by a surgical pathology system as an
inappropriate specimen type for the patient. Even further, an EHR could fail to
prompt a provider from making a prostate cancer risk assessment in a
transgender woman, which could result in improper screening.
I would recommend that EHR includes three
separate fields (sex assigned at birth, gender, and legal sex) to fully
recognize transgender patients and provide optimal personalized healthcare to
Gupta S, Imborek KL, Krasowski MD. Challenges in Transgender Healthcare: The Pathology Perspective. Lab Med. 2016 Aug; 47(3):180-188.
Stroumsa D, Roberts EFS, Kinnear H, Harris LH. The Power and Limits of Classification – A 32-YearOld Man with Abdominal Pain. N Engl J Med. 2019 May 16;380(20):1885-1888. doi:10.1056/NEJMp1811491.
-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
Kumarasen Cooper, MD, PhD completed his medical training
from his home country in South Africa and his PhD at Oxford. He now works as a
surgical pathologist at the University of Pennsylvania and is responsible for
leading the initiative to engage the pathology department in the Botswana-UPenn
partnership through the Perelman School of Medicine Center for Global Health. He
has over 260 publications and has lectured in 5 continents. Despite this busy
schedule, Dr. Cooper devotes two separate months of the year to work in
Botswana’s only academic pathology department, where he pours his energy into
helping the department advance.
I met Dr. Cooper through email when I heard about the work
he was doing in Africa. He generously agreed to come visit my department to
give an excellent Grand Rounds lecture on his experiences working in Global
Pathology, and he led a much-appreciated resident slide session of unusual and
difficult cases from his work in Botswana. Humility and grace envelop Dr.
Cooper despite his brilliant accomplishments. He also proved to be incredibly
generous with a refusal of his speaker honorarium, in exchange for an agreement
that we would collect pathology textbooks to send to the under-supplied
residency program in Botswana. I’m excited to share the inspiring work that he
does through the Botswana-UPenn partnership with all of you today, as I think
this program could be used as a model for all institutes to involve their
pathology departments in global health opportunities.
Q: What began your interest
in global health?
A: I was born,
raised, and completed my medical training in South Africa. I spent 15 years
working as a Pathologist and served as the Chair of Pathology in Johannesburg
until I was recruited to the US to work as Vice-Chair at the University of
Vermont. I knew when I left Africa that I would always come back, and that I
could use what I learned abroad to give back in some way. I wasn’t sure in what
form that would take at the time, but I knew there was work that still needed
to be done. This was also influenced by my visits to the pathology departments
in many different countries over the years…I was able to gain a sense of the
‘haves and have-nots’, and so developed a strong feeling that I needed to give
A: When I first discovered
the partnership, I thought that this may be an avenue for me to participate in
global pathology. At the time, the pathology department was not involved in any
of the ongoing BUP projects, though other clinical departments at UPenn were. After
my initial assessment of the Botswana pathology department and its resources in
April of 2016, I was able to identify ways that I could help. Together with the
Director of BUP, I approached the Chairman of my department with the proposal,
and we started the pathology partnership program in October of that year. Since
then, I travel to Botswana twice a year for one month at a time, and each time
I take 1-2 residents from UPenn along with me.
Q: Can you describe
the pathology department in Botswana?
A: To serve a
population of just over 2 million people, Botswana has only one academic
pathology department, a College of the University of Botswana (UB) School of
Medicine, which consists of six pathologists who
are all from other countries. There are currently no Botswana pathologists
working in the department. There are about six technicians working in the
laboratory, all of whom were trained internationally. The laboratory receives
around 7,000 surgical specimens yearly, plus cytology, and autopsy. They work
with an extremely limited panel of immunostains that are not routinely used but
are spared for the rare case that cannot be diagnosed with morphology alone.
The residency program is still very new. There are six
residents in the program at the present time, and the program is designed so
that they will spend the first two years in Botswana and then they will
continue their final years of training in South Africa. I look forward with
anticipation to the first Botswana trained pathologists in the country.
Q: What is your role
when visiting Botswana?
A: We try to help
with everything we can. I sign out cases with the residents during the time I
am there, and I teach the residents using these cases every day. The UPenn
residents that I bring with me are eager to teach as well, so they deliver
didactics regularly also. We all participate in tumor boards and the FNA
clinic. We each take on projects that we can partner with them to tackle…things
like improving turnaround time, quality improvement, and SOP preparations. We also work on developing academic programs, grossing
templates and manuals (A UPenn pathology PA spent two weeks working in Botswana
on this project), synoptic reports, cancer guidelines…anything they need I try
to help them with.
Q: How are the UPenn pathology
residents given credit in their home program to join you?
A: As of this
year, the BUP pathology program is now offered as one of the official electives
that residents are allowed to choose from. They are able to use elective time
and their travel expenses are paid for by a resident travel grant.
Q: In your role as
supervisor of the UPenn residents, what do you see the residents gaining from
A: The residents
that have come with me to Botswana are very compassionate and are eager to
contribute in any way they can. Experiencing pathology in Botswana, where
people are trying to achieve so much with so little resources, it makes the
UPenn residents even more grateful for all of the resources they have available
to them. They also have the opportunity to not only learn from the unusual
cases that present in Botswana, but also the opportunity to contribute their
own unique set of skills – some have focused on teaching autopsy technique,
others give enthusiastic and detailed
lectures, and one gave a talk about successful study techniques. [For more
information about the resident experience, one can read more about it in the UPenn
blog here: https://pathology.med.upenn.edu/department/blogs/residency-matters/penns-pathology-residency-program-reaches-botswana]
Q: How do you see the
BUP pathology partnership affecting the trainees in Botswana? What changes have
you seen since you started working with them?
A: The residents in
Botswana really appreciate the partnership that we have formed. I have seen the residents develop so much
since working with them. At first, they were reserved and now they actually
request lectures on topics they feel they could improve on. They are still very
humble and respectful, but I have encouraged them to be advocates for
themselves. They have really embraced their program and I’m very proud of them.
We have a deep appreciation for each other and are proud of what we have
We’ve also started hosting Botswana residents at UPenn for a
one month rotation so they have the opportunity to supplement their training
even further. We fly them to the US, house them, and include them in our
residency training program for the month. They have the opportunity to sit in
on sign-outs, shadow grossing and autopsy, attend conferences, and be exposed
to the advanced testing that we routinely perform in the US.
Q: How do you see the
pathology partnership growing in years to come?A: I’m currently helping them find placements in
South Africa or possibly partnering with private laboratories to help expose
the residents to a greater diversity and volume of cases. As the program
continues to grow, we look forward to seeing the fruits of the partnership for
many years to come.
-Dana Razzano, MD is a Chief Resident in her third year in
anatomic and clinical pathology at New York Medical College at
Westchester Medical Center and will be starting her fellowship in
Cytopathology at Yale University in 2020. She was a top 5 honoree in
ASCP’s Forty Under 40 2018 and was named to The Pathologist’s Power List
of 2018. Follow Dr. Razzano on twitter @Dr_DR_Cells.
Last month, it was as fun to write about hematology peripheral
smear differentials as it was to address the importance of
interdisciplinary collaboration. I found myself in a unique position both as a
medical student as well as a former medical laboratory scientist in what was a
great clinical training rotation in hematology/oncology. Now, with just one
rotation left until the end of my medical school journey, I want to take you on
a look back at some of the very first posts I made here on Lablogatory and
update you on the intersectional, collaborative topic that I shared with you
almost two years ago: Zika!
In a recent digital article on ASCP’s partner, The
Pathologist, author and staff editor Michael Schubert wrote about the
connectivity between public health, epidemiologic research, laboratory
medicine, and clinical patient outcomes. He examined the effectiveness and
accuracy of Zika testing availability in commercially available assays and
spoke with a leading virologist in the field from Berlin. You may recall one of
those “ancient” posts I made about Zika, where I was part of a research team
that used the same methodology! Combined immunoglobulin-specific assays,
arbovirus detection in the heat of a public health epidemic’s epicenter, and
lab medicine that complimented my concurrent immunology class in med
school—what more could you ask for?
And, since the last tagged Lablogatory Zika update I can see
by Dr. Sarah Riley in February of 2017, here’s my update! Dr. Riley’s post
was a fantastic summary of the Zika epidemic, its troublesome diagnostic
assessments, and the recommendations and plans of organizations like the World
Health Organization (WHO). She was, and still is, right—the “struggle is still
real’ when it comes to Zika testing. Curious about what it was like during the
2016 epidemic? Who was doing testing, what kind of testing, and what was the
lab data climate? Well…it feels like it’s time for a…
*** FLASHBACK ***
An Arbovirus Abroad
Hey! My inaugural
post! It was fun to go back and see the data from the work then (Spoilers:
epidemiologic updates are on your horizon). We were just getting started to
take an assessment of the situation and address it as a public health concern.
My then Caribbean location was a great place to study Zika trends coming from
Brazil, Puerto Rico, and Florida. As a snapshot, at that time (Dec 2016) there
were a purported almost 2,000 cases, however less than a fifth of those cases
were serologically confirmed by lab testing. Before the recommendations to move
toward RT-PCR, most labs in the region were requesting commercially available
screening tests for IgG/IgM assays.
How do you reach people when you’ve got compelling public health
lab data that translates to possible prevention of infection and spread of
disease? Easy: go
to where the people are and engage them when and where they’re comfortable.
One of the overarching themes in public health is mitigating barriers to change
by way of utilizing social humility. This a certainly a type of
interdisciplinary collaboration because if we’re the experts on IgM and IgG
trends in testing confirmations, the public are the experts in social
determinants of health within their communities.
Laboratory Data and Global Health Security
As my team and I were busy preparing SOPs, conducting a new
project aimed at improving local health literacy and source reduction, securing
IRB approval, and collecting data about the residents of Sint Maarten to
correlate with local Health Ministry projections, one of the officials—who now
serves as a regional director for PAHO—took our work to the Global
Health Security Agenda Summit. Talk about motivation! In and out of the
lab, I worked with teams who were getting some fantastic work done on the
ground with respect to mosquito-borne virus research.
IRBs and Public Heath Pathology
For those of us who work in laboratory medicine, it’s easy
to talk about the best way to test, detect, and treat an epidemiologic
threat—it’s even exciting when it’s a current threat. But to really be
successful, you’ve got to collaborate with those outside of the lab, and often
this means thinking “outside the box.” Public
health is different from lab medicine in that while lab-work is based
around results, testing, and organized data-driven decisions, success in public
health is highly determined by community buy-in in the form of partnerships!
*** FLASH …
So, after my time in Sint Maarten, I came to New York City
to rotate through my clinical clerkships. And, if you’ve seen some more recent
post-Zika posts on this website, you know they’ve been going great! Within a
few months of being here, my wife brought back some swag from a training
session she attended. (Side note: she’s a graduate-level nurse, working in the
public health non-profit sector with vulnerable populations in the inner
city—she’s too busy to blog.) After months of both of us working and learning
about Zika and public health initiatives in the Caribbean, we were greeted by
this fantastic toolkit from the New York State Department of Public Health!
The take home message: collaboration is key, both inside and
out of the lab. Schubert’s piece in The Pathologist created a fantastic
dialogue in addressing the clinical needs for interdisciplinary collaboration.
The best testing means finding out exactly where the needs are and using
data-driven decisions to implement change or action. In the lab, that means
constantly working for higher quality and better patient outcomes in every
test, result, report, and (mosquito) byte of data. In the field, it means the
same thing, but instead of metrics like sensitivity, specificity, and TAT it’s
about cultural humility, attainable goals, and dynamic timing.
Thanks for reading! Hope most of our national heat wave spared you, but if it didn’t remember: don’t keep standing water around, wear light loose clothing, and use appropriate insect repellent!
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.
who works in a laboratory knows that there are certain rules and regulations to
be followed to ensure accuracy in testing, and the safety of both the patient
and testing personnel. With all the acronyms floating around (CLIA, FDA, CAP,
CMS, TJC) it can get confusing to keep track of who controls what, and which
rules apply to your specific lab. In the first installment of this 3-part
series on regulations, we’ll review the different federal agencies responsible
for oversight and moderation of the laboratory. In part 2 we’ll go further
in-depth to demystify testing complexity (waived, non-waived, PPM) and why it’s
important to know the correct classification for the tests you perform. Lastly,
we’ll review the optional accreditations available to labs, and how
accreditation differs from certification.
refers to the Clinical Laboratory Improvement Amendments of 1988. These
amendments were drafted to the Public Health Services Act, in which the federal
program was revised to include certification and oversight of clinical
laboratory testing. Although there have been two additional amendments made
after 1988 (1997, 2012), the law still continues to be cited as CLIA ’88 as it
is named within legislation.
CLIA regulations helped to establish quality standards for all U.S. laboratory
testing performed on human specimens (except for research) for the purpose of
assessment of health, or the diagnosis, prevention, or treatment of disease.
The regulations cover all aspects of testing including general laboratory
requirements, quality monitors, pre-analytics, analytic performance,
post-analytics, and personnel requirements.
addition to setting the basic ground rules for performing quality laboratory
testing, the CLIA regulations also require clinical laboratories to be
certified by their state as well as the Center for Medicare & Medicaid
Services (CMS) before accepting human samples for diagnostic testing.
Laboratories can obtain multiple types of CLIA certificates, based on the kinds
of diagnostic tests they perform. In order for laboratories to receive payments
from Medicare or Medicaid, laboratories must be properly certified for the
testing they are performing and billing for.
3 federal agencies responsible for enforcing the CLIA regulations: The Food
& Drug Administration (FDA), Center for Medicaid Services (CMS) and the
Center for Disease Control and Prevention (CDC). Each agency has a unique role
in assuring quality laboratory testing.
Centers for Medicare & Medicaid Services (CMS) is the federal agency
responsible for ensuring that the CLIA standards are upheld and enforced. Their
responsibilities include the following:
inspections and enforcing regulatory compliance
private accreditation organizations (such as CAP) for performing inspections,
and approves state exemptions
laboratory performance on Proficiency Testing (PT) and approving PT programs
CLIA rules and regulations
& Drug Administration (FDA) is primarily responsible for reviewing and
approving new tests, instruments, and equipment used in diagnostic laboratories.
They also perform the following tasks:
tests based on complexity
requests for Waiver by Application from manufacturers
rules/guidance for CLIA complexity categorization
for Disease Control and Prevention (CDC) responsibilities include the following
analysis, research, and technical assistance
technical standards and laboratory practice guidelines, including standards and
guidelines for cytology
laboratory quality improvement studies
proficiency testing practices
and distribute professional information and educational resources
the Clinical Laboratory Improvement Advisory Committee (CLIAC)
summarize, CLIA establishes the rules and guidelines that laboratories must
follow to ensure they are providing accurate laboratory results. Federal
agencies then work together to support the CLIA amendments and enforce
compliance. All certified laboratories will be subject to inspection by
regulatory agencies to ensure compliance with the rules. In some cases, your
local state Department of Health (DOH) or accrediting agency may be more
stringent or have additional requirements to be followed – always go with the
stricter requirement to ensure compliance with all agencies.
up next we’ll review how the FDA decides the complexity of each test, and how
this designation will affect the CLIA rules to be followed.
-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.
The general public doesn’t always know a lot about laboratory
testing in general, but most people know a little about blood types, even if
it’s what they have learned from TV! Blood types do seem to come up in casual
conversation. We might hear a conversation about blood type after someone has
donated blood, or between family members comparing notes, who ask “What’s your
type?” Yet, even with medical technologists, there can still be some confusion
about blood types and blood typing, particularly if one has not worked in Blood
Bank in many years. I recently received an email from a colleague who had a few
questions about blood types, as she has not worked in Blood Bank for over 40
years. I always tell my students that no question is a bad question, and indeed,
she asked some very good questions, which I will address with this case study.
What blood type is listed on a patient’s chart if they type “O
What blood type is recorded on a donated unit of blood typed “O
What type of blood does an “O Du” patient receive?
Can an “O Du” patient have a transfusion reaction if they are
transfused with O positive blood? Would she need to receive O negative blood in
Does an “O Du” patient need to receive RhoGAM if she pregnant and
her husband is Rh positive?
If you have ever wondered or can’t remember details about any of
these questions, you’re in the right place. So, what’s new, if anything, with
Landsteiner discovered the ABO blood group system in 1901, and
identified A, B and O blood types, using experiments performed on blood from
coworkers in his laboratory. The discovery of the codominant AB blood type soon
followed, but it was not until around 1940 that the Rh blood group was first described.
In 1946, Coombs and coworkers described the use of the antihuman globulin (AHG)
to identify weak forms of Rh antibodies in serum. For us old blood bankers, the
original name for this test was the Coombs’ test. (You will still find
physicians ordering a Coombs’ test!) The current and proper name for this is
the direct antibody test (DAT), which is used to detect in vivo sensitization
of RBCs. AHG can also be used to detect in- vitro sensitization of RBCs using
the 2 stage indirect antibody test (IAT).
Since Landsteiner’s work, we have not discovered any new blood groups
that are part of the routine blood type. The ABO and Rh blood groups are still
the most significant in transfusion medicine, and are the only groups consistently
reported. However, we currently recognize 346 RBC antigens in 36 systems.1 Serological tests determine RBC
phenotypes. Yet, today we can also determine genotype with family studies or
molecular testing. This case study and 2 part blog reviews some terminology in
phenotyping, some difficulties and differences encountered, and explores the
possibility of RHD genotyping to assess a patient’s true D status.
Our case study involves a 31 year old woman who is newly married.
She is not currently pregnant, has never been pregnant, is not scheduled for
surgery but has had a prior surgery 15 years ago, and has never received any
blood products. She and her husband recently donated blood and, as first time
blood donors, just got their American Red Cross (ARC) blood donor cards in the
mail. The husband noted that his card says that he is type O pos. The woman
opens her card, and, with a puzzled look on her face, says “My card says I’m an
O Pos, too. There must be a mistake.” She knows she has been typed before and
checks her MyChart online. Sure enough, her blood type performed at a local
hospital is listed in her online MyChart as O negative. She further checks
older printed records and discovers that 15 years ago, before surgery, she was
typed at a different hospital as “O Du”. She is very upset, wondering how she
can have 3 different blood types. She is additionally concerned because they
are planning to have children and recalls being told that because she is Rh
negative, that she would need Rhogam. Is she Rh negative or positive, and what
does Du mean? Will she need Rhogam when pregnant? She has many questions and calls
the ARC donor center for an explanation.
What blood type is listed on a patient’s chart
if they type “O Du”?
What is happening here, what is this woman’s actual blood type, and what testing can be done to ensure accuracy in Rh typing? From the patient reports, it appears that this woman has what today we call a “weak D.” Du is an older terminology that should no longer be used, and that has been replaced by the term “weak D.” But, why does she have records that show her to be an O neg, a type O, Du (today, this would be written O weak D), and now, a card from ARC stating she is O pos?
RhD negative phenotypes are ones that
lack detectable D antigen. The most common Rh negative phenotype results from
the complete deletion of the RHD gene. Serologic testing with anti-D is usually
expected to produce a strong 3+ to 4+ reaction. A patient with a negative
anti-D at IS and at IAT would be Rh negative. If the patient has less than 2+ strong
reaction at immediate spin (IS), but reacts at IAT, they would be said to have
a serologically weak D.1 Historically, weak D red blood cells (RBCs)
are defined as having decreased D antigen levels which require the IAT for
detection. Today’s reagents can detect many weak D
types that may have been missed in the past, without the need for IAT. However,
sometimes IAT is still necessary to detect a weak D. When this is necessary is
dependent on lab SOPs and whether this is donor testing or patient testing. The
reported blood type of this patient also depends on the SOPs of the laboratory
that does the testing. And, the terminology used for reporting is also lab
dependent. It is not required by AABB to test patient samples for weak D
(except for babies of a mother who is D negative). There is also no general
consensus as to the terminology to be used in reporting a weak D. Some labs would
result this patient as O negative, weak D pos. Some labs may result O pos, weak
D pos. Others may show the individual reactions but the resulted type would be
O pos. Labs who do not perform weak D testing would report this patient as O, Rh
negative. The following chart explains why this patient appears to have 3 types
What blood type is recorded on a donated unit
of blood typed “O Du?”
AABB Standards for Blood Banks and
Transfusion Services requires all donor blood to be tested using a method that
is designed to detect weak D. This can be met through IAT testing or another
method that detects weak D. If the test is positive, the unit must be labeled
Rh positive. This is an important step to prevent alloimmunization in a
recipient because weak D RBCs can cause the production of anti-D in the
recipient. This also explains why the ARC donor card this patient received
lists her type as O pos.
of blood does an “O Du” patient receive?
Historically, weak D red blood cells
(RBCs) were defined as having decreased D antigen levels which require the IAT
for detection. A patient who is serologic weak D has the D antigen, just in
fewer numbers. This type of weak D expression primarily results from
single-point mutation in the RHD gene that encodes for a single amino acid
change. The amino acid change causes a reduced number of D antigen sites on the
RBCs. Today we know more about D antigen expression because we have the
availability to genotype these weak D RBCs. More than 84 weak D types have been
identified, but types 1, 2, and 3 represent more than 90% of all weak D types
in people of European ethnicity.2 An Rh negative patient has no D
antigen and should, under normal circumstances, only receive Rh negative blood.
Yet, there has been a long history of transfusing weak D patients with Rh
positive RBCs. 90% of weak D patients genotype as Type 1, 2 or 3 and may
receive Rh positive transfusions because they rarely make anti-D. 2
It is now known that weak D can actually
arise from several mechanisms including quantitative, as described above, position
effect, and partial D antigen. Molecular testing would be needed to
differentiate the types, but, with the position effect, the D antigen is
complete and therefore the patient may receive Rh positive blood with no
adverse effects. On the other hand, a partial D patient may type serologically
as Rh negative or Rh positive and can be classified with molecular testing. It
is important to note that these partial D patients are usually only discovered
because they are producing anti-D. If anti-D is found, the patient should
receive Rh negative blood for any future transfusions.
Thus, 3 scenarios can come from typing
the same patient. With a negative antibody screen, and because 90% of weak D
patients have been found to be Type 1, 2 or 3 when genotyped, many labs do not routinely
genotype patients and will report the blood type as Rh pos and transfuse Rh pos
products. However, depending on the lab medical director and the lab’s SOPs,
these same patients may be labeled Rh neg, weak D and receive Rh negative
products. There is no general consensus on the handling and testing of weak D
samples. The 3rd scenario is that many labs do not test for weak D
in patients at all, and a negative D typing at IS would result in reporting the
patient as Rh neg, with no further testing. In this case, the patient would be
transfused with Rh negative products.
Can an “O
Du” patient have a transfusion reaction if they are transfused with O positive
blood? Would she need to receive O negative blood in a transfusion?
This question was covered
somewhat in the above discussion. Policies regarding the selection of blood for
transfusion are lab dependent, dictated by the lab medical director, and are
based on the patient population, risk of developing anti-D, and the
availability or lack of availability of Rh negative blood products. Anti-D is
very immunogenic. Less than 1 ml of Rh pos blood transfused to an Rh negative
person can stimulate the production of anti-D. However, not all patients
transfused with Rh positive blood will make and anti-D. As discussed above, 90%
of weak D patients are types 1, 2 or 3, would be unlikely to become
alloimmunized to anti-D. If a weak D patient with a negative antibody screen
receives a unit of D pos RBCs, there is a very small possibility that they are
a genotype who could become alloimmunized to the D antigen and produce anti-D. However,
as stated above, the majority of weak D patients can be
transfused with D positive RBCs. Thus, with few exceptions, from a historical
perspective, one can safely classify the weak D as D positive.
This question gets a little trickier
when dealing with females of childbearing age. We particularly want to avoid
giving Rh positive blood to females to avoid anti-D and the complications of
Hemolytic Disease of the Fetus and Newborn. Therefore, when dealing with these
patients, lab policies and physicians tend to be more conservative in their
approach to transfusion. The consequences, however, in males and older females
are less serious and these patients could be given Rh positive blood if there
exists a shortage of Rh negative units. Any patient who becomes alloimmunized
to the D antigen, would thereafter be transfused with Rh negative products.
Does an “O
Du” patient need to receive RhoGAM if she pregnant and her husband is Rh
This, again, would be up to the medical
director, the lab’s SOPs or the patient’s physician. Depending on lab practice,
the lab may or may not perform weak D testing. If the lab does not perform weak
D and results this patient as Rh neg, the patient would get Rhogam. If the lab
does do weak D testing and finds a weak D phenotype, the decision whether or
not to give Rhogam would be up to lab practices and the practitioners involved.
The lab’s policy on terminology used in resulting the type may also reflect the
decision whether or not to give Rhogam. This brings up a lot of questions in
the lab because we know that a patient who would not make anti-D would not need
Rhogam. So, what is the best course of action? Read my next blog to learn more
about troubleshooting and resolving D typing discrepancies!
From the discrepancies in reported type in this individual, and putting all the pieces of the puzzle together, we can conclude that this patient is a weak D phenotype. However, the type reported and the terminology used varies from lab to lab. Molecular testing is available, yet most labs are still using serological testing for blood types for both donors and patients. This is based on several factors within the lab setting. Stay tuned for my next Blood Bank blog exploring D typing discrepancies and the financial aspects of performing genotype on pregnant patients to clarify Rh type.
-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.
Large biological and chemical spills are not a common
occurrence in the laboratory. That’s a good thing, but when they do occur, they
can create a very dangerous situation. It is vital that lab staff know how to handle
such events even though they may not be commonplace.
Some laboratories differentiate between large and small
spills. They may have an emergency number to call for a hazardous spill
response team. Other smaller facilities simply don’t have that in place. Either
way, it’s important for laboratory professionals to know they are the experts
about the biological and chemical materials they use, and they need to be in
charge as the experts when a spill situation needs to be managed.
Most laboratory spills can be managed using a standardized step-wise
process known as the S.P.I.L.L.E.D. procedure. I don’t usually ask lab staff to
memorize the acronym, but having the information contained on a poster with the
lab spill kits can make a clean-up procedure go smoothly.
S = Secure the Site – Make sure no one walks through the
area where a spill has occurred. It could be a dangerous situation if a
hazardous chemical is spilled, and you would never want someone slipping in the
area or tracking the spilled material to another area.
P = Protect Yourself – Arm yourself with the
appropriate Personal Protective Equipment (PPE). In a lab spill event, this
would mean using a lab coat, gloves, and face protection to prevent accidental splashes.
I = Inspect the Spill – Look to see what was spilled.
If it is a hazardous chemical, is there a concern about fumes? Obtain a Safety
Data Sheet to see if section 6 will give any special information about handling
the accidental release or spill of that chemical. Consider other spill concerns
such as broken glass or possible ignition sources if flammable material is
L = Lay Down a Barrier – If the spill is large and
spreading, lay down spill pillows or booms designed to contain a flow of
liquids. Surround the spill area with these materials. Sometimes, the use of an
emergency shower can create the need for a barrier to be made.
L = Lay Down Absorbents – No matter the size of the spill,
the next step is to place any absorbent powders, granules or clean-up pads to
soak up the spilled material. If the absorbent is also a neutralizer, make sure
you allow the necessary time for neutralization to occur.
E = Extract the Mess – Use implements to pick up the
materials used for stopping and absorbing the spill.
D = Dispose of the Waste – Properly dispose of all
materials involved with the spill clean-up. If there was glass involved, be sure
to use a sharps container. Biohazard
material should go into an appropriate container, and chemical waste materials
may need to be disposed of separately for pick-up by a chemical waste vendor.
Lab staff should be able to access spill control materials
quickly, and the necessary items should be stored in a location designated by
signage. Perform an inventory of spill supplies and make sure there are
adequate materials that could handle spills of the biohazards and chemicals stored
and used in the department. Be sure items in the spill kit are not expired, and
if there is no expiration date for absorbent powders, check them at least
annually for effectiveness.
All laboratory staff need to have complete spill clean-up
training. Give information about the types and locations of spill kits and how
to handle various types of spills that can occur. Once that training is done,
it will become important to perform spill drills in the department. Drills can
be performed a number of different ways, but a common method involves having a “victim”
spill water onto the floor and claim the material splashed into their eyes.
Watch from a distance to see how the staff reacts. Do they provide appropriate
first aid? Do they inspect the container label? Do they access the correct
clean-up supplies and facilitate cleaning efficiently? Make notes of how the
drill went, discuss them with the staff, and repeat the drills until all staff
are comfortable with a spill situation.
and chemical spills should not be a common occurrence in the lab. When they do
occur, however, the situation can become serious quickly, and a fast and effective
clean-up needs to occur. Because these events are rare, it becomes important to
provide regular spill training and drills so staff can remain ever-ready to
–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.