So far
we have reviewed the different federal regulatory agencies responsible for
establishing laboratory testing guidelines, a brief overview of the different
roles each department plays, as well as a discussion on testing complexity. In
today’s post we’ll cover the optional accreditations available to labs, and how
accreditation differs from certification.
In the
simplest of terms, certification is a mandatory requirement, whereas accreditation
is optional. Certification is required in order for laboratories to receive
payments from Medicare or Medicaid. Laboratories must meet the minimum
requirements set forth by CLIA to earn and maintain their certification status.
Accreditation
is an extra additional step that laboratories can take to set themselves apart
from neighboring labs by holding themselves to a higher standard. Accredited
laboratories must still adhere to the minimum CLIA requirements, but there are
additional rules and requirements to be satisfied depending upon the different
accreditation agencies.
More
rules and paperwork, why would anyone volunteer to take that on? Depending on
the size, complexity, and client population that your lab serves, the benefits
to obtaining accreditation can greatly outweigh the challenges of maintaining
that accreditation status.
One of
the requirements to maintaining your CLIA certification is routine inspections
to confirm compliance with the rules. Accreditation agencies require
inspections as well, but thankfully in most cases your CLIA inspection can be
satisfied by your accrediting agency; meaning your lab will receive a single
inspection to satisfy both groups. Results will vary for each lab, but
generally speaking the accreditation inspections are perceived to be easier to
get through than those conducted by the federal inspectors. For example, agencies
like The CAP and COLA tend to be more focused on sharing of ideas and good
laboratory practices, rather than coming in as the “lab police” and looking
only for problems. The explanation of their regulatory requirements tends to be
more user friendly and easier to interpret as well, rather than the formal CLIA
laws which are legal documents and read as such.
Recognition
by an accrediting agency confirms that the laboratory is qualified and
competent to perform testing for which it has received the accreditation for.
This stamp of approval can help patients and clients feel comfortable in
choosing your laboratory for their testing needs. For laboratories that perform
testing as part of clinical trial evaluations, this can help reduce the number
of requested on-site audits by the client themselves, as the client may choose
to rely on the third-party accreditation assessment due to their high
standards. It may also help encourage new clients to choose you for their
testing needs, as the accreditation confirms your commitment to higher quality
standards.
Another
possible benefit of having accreditation status is the impact on your laboratory
staff. Continually striving to raise the bar on your standards and going above
the bare minimum instills a sense of professionalism in your employees. By
continually reviewing the regulations and preparing for or responding to
inspections, staff are more likely to be committed to complying with your
organization’s quality management system and standards of performance. Staff
who are familiar with the requirements and the reasoning behind why a certain
task is performed or documented, are more likely to comply with those policies
and procedures.
There
are currently 7 CLIA approved accreditation agencies: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf. Some agencies are focused on a
specific discipline, such as AABB for transfusion medicine, and others are more
encompassing for all of the laboratory departments. Organizations looking to become accredited
should research each option in order to determine which ones would be best to
meet their specific needs. It is also common for labs to maintain more than one
accreditation at a time, for example AABB and CAP. As always, the regulatory
agency with the most stringent rules would be the ones the lab is expected to
adhere to. In cases of joint accreditation, multiple inspectors may be needed
to complete the biennial inspection; however the agencies will try to
coordinate efforts and work together so that the inspections occur
simultaneously. Sticking with our AABB & CAP example, CAP will work with
AABB to locate an AABB approved inspector for the transfusion medicine
checklist, while the remainder of the CAP inspection will be carried out by CAP
inspectors. The AABB inspector would then inspect the transfusion medicine
department for compliance with both CAP and AABB requirements at the same time.
The accreditation process may be challenging, but once you have obtained that esteemed status, the opportunities for continual education and improvement of your laboratory will be endless.
-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.
I’m writing to you now back in Manhattan after visiting
sunny Phoenix, AZ for this year’s ASCP Annual Meeting. Last month
I talked about downtime, pathology emergencies, and introduced you all to our
insightful and dynamic colleague, Jalissa Hall. It was great working with her
and one of the last things we talked about was getting to go to professional
society meetings. We also talked about the upcoming meeting next year in
Austin, TX! And that’s exactly what I’d like to talk about with you this time:
why going to meetings like ASCP is not only educational, but an excellent way
to network with your laboratorian peers from around the country.
Image 1a. My wife and I made it to the Phoenix Hyatt Regency on registration day! ASCP swag on, obviously.Image 1b. Behind the Scenes – Hosting the ASCP 2019 Facebook Live broadcast with two fantastic colleagues, Dr. K. Mirza and Dr. A. Booth! Did you catch us? But more about social media later…
I couldn’t go to every single session—there’s just too
many—but I did learn so much valuable, practical information at the educational
sessions. Here are just a mere few insights from the long list of fantastic
speakers I had the chance to visit!
I participated in an interactive session on the
ASCP/CAP/ASH guidelines for lymphoma workup…
Figure 1. All the multidisciplinary expertise must go through rigorous adjustment and evaluation all the way throughout the process of seeking out and publishing proper guidelines. (Source: ASCP 2019 session 5007-19; Kroft, S., Sever, C., and Cheung, M.)
Drs. Kroft, Sever, and Cheung discussed updates from the WHO
2016 guidelines as well as relating any changes in concurrent literature to
appropriate diagnostic accuracy with evidence-based guidelines. If it sounds
familiar, it’s because I talked about these guidelines a
few months ago! In my month clerkship at The Mayo Clinic in Rochester, MN I
presented a therapy-related AML case in the setting of Li-Fraumeni disorder. In
my discussion I stressed the utility and importance of having organized and
algorithmic guidelines to diagnose patients accurately, effectively, and
timely. This time, instead of just talking about the guidelines, I got to
listen to some of the folks who actually put them together—and,
according to them, it’s no easy task!
I learned about culturally appropriate leadership
training…
Figure 2. The panelists each had something insightful and moving to contribute to this wonderful discussion on female empowerment in our profession, and ultimately how it relates to improving patient care! (Source: ASCP 2019 session 8012-19; Mulder, L., Upton, M., Vuhahula, E., Abedl AlThagafi, M., Papas, F., and Sanford, K.)
This year’s ASCP president, Dr. Melissa Upton moderated this
fantastic panel and opened with an old proverb: “If you want to go fast, go
alone. If you want to go far, go together.” This was definitely a theme for
each of the mini-sessions’ discussions. ASCP’s own Lotte Mulder discussed her
research on culturally applicable leadership training using her Leadership
Institute Initiative. She talked about countries that are culturally different
and developmentally different up and down the spectrum can all benefit from
leadership development and opportunity. Next came Dr. Edda Vuhahula, an
accomplished physician, educator, and advocate in Tanzania. She related her
experiences of women in leadership roles, and challenges on the horizon as more
women rise to these positions every day. Dr. Malak Abed AlThagafi talked about
her “hats:” as an entrepreneur, a medical director, and a researcher in her
whirlwind story of empowerment and accomplishment. Finally, medical laboratory
scientist and former Philippine Army colonel, Filipinas Papas gave her personal
perspectives on sexism, education, bias, and opportunity.
Celebrated my colleagues and my contributions to the 6thChoosing Wisely list of recommendations…
Figure 3. My totally biased favorite slide from Dr. Lee H. Hilbourne, chair of the ASCP Effective Test Utilization Steering Committee. It’s an honor to be included in this year’s list, alongside so many accomplished contributors.
The Choosing Wisely initiative, partnering with the
American Board of Internal Medicine and many other specialty organizations, is
one of my favorite programs at ASCP. To date, our lab medicine organization has
the highest number of effective test utilization recommendations. ASCP seeks
active contributions to our expanding lists of recommendations to eliminate
wasteful, unnecessary testing and to improve patient outcomes. This talk was
also a great opportunity to honor the ASCP 2019 Choosing Wisely
Champions: Dr. Gary W. Procop from the Cleveland Clinic, Dr. Lucy Nam from the
Inova Lab best practice team, and Dr. Alyssa Ziman from UCLA Health. Want to read
the most updated list of recommendations ASCP made to the Choosing Wisely initiative?
I watched some cutting-edge exchanges about cellular
therapy…
Image 2. Here I am with laboratorian S. Malakian and Dr. Gastineau with The Mayo Clinic after they discussed the future of complex cell therapies.
One really effective take-home message from this seminar was
that, if we’re going to rely on cellular therapy in the future—especially as it
relates to “individualized medicine”—then who do you think should be in charge?
Who’s got the most experience and knowledge when it comes to cell storage,
transfusion protocol, patient outcomes, and high reliability? Short answer:
it’s us. Long answer: go back and check out a piece
I wrote about high-stakes responsibility in and out of the lab!
Popped into fascinating hematologic cases at our
neighboring SHEAHP2019 meeting…
Listen, I like hematopathology, I’ll be the first to tell
you that. There were so many people giving presentations in this near
standing-room-only meeting, that I recognized from papers, abstracts, and
journals that I’ve read in the past year alone! There were so many interesting
sessions at this meeting, I wish I could have seen more…
Image 3. Here’s Dr. J. Dalland from Mayo Clinic Pathology discussing a lymphoproliferative disorder with associated eosinophilia. These talks go deep into morphology and photypic patterns, so that Hemepath colleagues have a chance to assess their workup and protocols. It’s also great learning for avoiding pitfalls—this case shows architectural changes in lymph nodes which could cause someone to misdiagnose!
Learned how to create an impactful dialogue with patients
directly…
What do you do as a pathologist when a patient wants to
speak to you? Yes, you. Not a typo! This was the last talk I went to and it was
a great way to close out this awesome conference.
Image 4. Me with (left to right) Dr. K. Sanford from VCU, Patient Champion Anthony Reed, Dr. M. Sitorius from the University of Nebraska, and M. Mitchell. All of these individuals had amazing things to say about bridging the gap between the bench and the bedside!
In their own ways these patient advocates demonstrated that
if you want to represent our lab profession as one of accuracy, answers, and
hope, we’ve got the skills and resources to do it! Dr. Sanford sees so many
patients in her transfusion services and discusses their care plans regularly.
Mr. Reed is an ASCP patient champion who, after being diagnosed with ESRD,
became a learned lab ally. Dr. Sitorius is a family medicine physician at a
pathology conference, talking about empathy and connection! Ms. Mitchell has
done fantastic work with her pathology colleagues after beating cancer and
fighting for patient education every day! These folks have taken our field of
laboratory medicine to its outer edges, touching patients’ lives directly—and I
left energized to take it further in the future.
And of course, I learned so much about the utilization of
social media as a practical tool for education, advocacy, and outreach…
I can’t list every single session, lecture, keynote,
presentation, or panel in this article. This was just a glimpse of what
meetings like this have to offer. You will learn, obviously, but you’ll also
gain access to new perspectives and meet people who reinvigorate your passion
for your profession in ways you didn’t even consider. One of the most
fulfilling experiences of this meeting was being on the ASCP Social Media Team!
Posting to Instagram, Facebook, and Twitter with the hashtags #ASCP2019,
#ASCPSoMeTeam, or the scavenger hunt #ASCPiSpy was a great way to bolster our
enthusiastic network. This was my third ASCP Annual Meeting, and I met so many
wonderful people I can’t wait for the next one! Here’s a few of my favorite
snaps from the meeting:
Image 5. Here’s part of our amazing #SocialMediaTeam: (left to right) A. Odegard from Baptist Health, myself, Dr. S. Mukhopadhyay from the Cleveland Clinic, Dr. A. Booth from the University of Texas, and Dr. K. Mirza from Loyola Chicago!Image 6. At my first ASCP meeting in California, Jeff Jacobs, ASCP’s Chief Science Officer, gave me some of the best advice for my own personal and professional growth, “Stay Humble” he told me. Nearly 5 years later, he added “Don’t Give Up” on goals, yourself, or anything in life. You can’t pick that up in a path review book. I feel lucky to know people like him.Image 7. #SoMe FTW (Social Media for the win!) At this great talk, Dr. C. Arnold, Dr. L. Shirley, and Dr. D. Gray III, all from the Ohio State University discussed how to use social media to build a reputation and expand your impact as a pathologist, educator, and advocate!Image 8: Conferences are a great time to run into old friends and colleagues whom you may have spent a month rotating with! If you read about my time at Danbury Hospital in Connecticut, Drs. O. Olayinka and G. Kuar were part of it and I’m glad to call them friends!Image 9: Presented by the ASCP Resident and Pathologist Councils, this was a great networking session to discuss fellowships, employment, and how to plan for the first 100 days of working in laboratory medicine from PGY-1 and on! I certainly learned a lot!Image 10: (left to right) Dr. K. Chaztopoulos from the Mayo Clinic, myself, and K.C. Booth, RN in front of his finalist poster in the scientific category! Another valuable professional connection and friend made through my experiences in laboratory medicine.Image 11. When one of your mentors (Dr. K. Mirza) is signing copies of The Pathologist magazine that featured him on the cover, you get in line for one …obviously.Image 12. Dr. M. Upton is an inspirational speaker and insightful individual both on stage and in person. She had words of encouragement for my upcoming residency interview season and made sure I felt I could rely on ASCP for whatever I needed professionally. Thank you, Dr. Upton!Image 13. Some more colleagues from Mayo Clinic Pathology (left to right): Dr. A. Ravindran, Dr. D. Larson, Dr. J. Dalland, and myself. These folks were very busy with all the great hematology sessions at the SHEAHP2019 meeting.Image 14: No ASCP Annual Meeting would be complete without the leadership, passion, and vision of our CEO Dr. Blair Holladay. He, his leadership team, and this organization have been integral in my path to pathology and I can’t wait to see what’s in store for the future!
Social media has become so valuable in our field. Not just
for networking, but sharing cases, impressions, publications, and more! It’s so
easy to rally behind a hashtag and support a cause in so many instances—why not
in our profession? Get involved, be an active voice for your own practice as
well as your colleagues.
If you want to learn more about the sessions you may have
missed, download the ASCP2019 app from the Apple App Store or Google App Store!
Thanks for reading! See you on social media, because when we
communicate and collaborate, we are #StrongerTogether! I’m on twitter at
@CKanakis, until 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.
Last
month we reviewed the different federal regulatory agencies responsible for
establishing laboratory testing guidelines, and a brief overview of the
different roles each department has. This month we’ll attempt to demystify
testing complexity (waived, non-waived, PPM) and why testing classification
matters. Still to come, we’ll review the optional accreditations available to
labs, and how accreditation differs from certification.
For all
in vitro diagnostic tests, the FDA is responsible for categorizing each test
based on their perceived complexity during the pre-market approval process.
From least to most complex, the categorizations are waived, moderate
complexity, and high complexity. The reason this is important is because with
each jump in test category, the CLIA rules associated with performing testing
will change – as will the permit designation required to perform testing. This
includes things such as QC requirements, validation testing, and personnel
requirements to define who can perform testing in the first place.
Waived tests are considered easy to use,
with little to no chance that the test result will provide wrong information or
cause harm if it is done incorrectly. This includes over-the-counter tests such
as home use urine pregnancy kits, where if the sample is applied incorrectly or
in insufficient volume there will simply be no result obtained at all. Many
Point of Care tests fall under this category, with testing performed in a wide
variety of locations including physician offices, urgent care clinics, imaging
centers and nursing homes. Locations performing waived testing only are still
required to obtain an appropriate CLIA Certificate of Waiver. (See the reference links at the end for a
list of all FDA approved CLIA-Waived tests.)
For
waived testing, laboratories must follow the manufacturer’s instructions for
testing, including the stated FDA approved intended use, without any deviation.
If the procedure is modified, or the test is used with specimens not approved
by the FDA – the complexity classification of the test will change from waived
to high complexity. A common situation where this occurs is with fingerstick
whole blood glucometers. Most device manufacturers on the market today for
point of care glucose testing are not FDA approved for use with
critically ill patients. Using these waived meters for patients deemed
“critically ill” based on your local institution’s designation would change the
complexity of testing from waived, to high, for this population of patients as
it would be considered “off-label use” – meaning you are using it against FDA
recommendations and approved forms of use for the test/instrument.
Another
caveat to be mindful of is your local state regulations. Certain states (NY,
especially) have very strict rules regarding testing complexity designation. In
NY, all tests performed within the same designated laboratory space will have
the same testing complexity designation. Meaning that if you have a moderate
complexity CBC analyzer in the same room you perform your waived urine
pregnancy tests – both are now considered moderate complexity. Even though
you’re following the manufacturer’s instructions for the pregnancy kit, using
only approved specimen types, and the kit is on the FDA approved CLIA-Waived list
– that test is now moderate complexity just because it is in the same room as
other higher complexity tests. That same pregnancy kit is considered waived
when kept separate in the emergency department, but becomes moderate complexity
(or higher) when used in the central laboratory.
Nonwaived tests refer to both moderate and
high complexity testing. After the FDA has approved a marketing submission,
their CLIA categorization of the test follows by utilizing a scorecard to grade
the test complexity on 7 different criteria. All phases of testing
(preanalytic, analytic and postanalytic) are evaluated in these steps:
Knowledge
– low scores require minimal scientific and technical knowledge to perform the
test, and knowledge needed can be easily obtained through on-the-job
instruction.
Training
& Experience – low scores require minimal training and limited experience
to perform the test.
Reagents
& Materials Preparation – low scores have stable and reliable reagents, and
require no special handling, precautions, or storage conditions. They typically
come prepackaged, premeasured, and ready for use; whereas high scores may
include manual steps such as volumetric measurements and/or reconstitution.
Characteristics
of Operational Steps – low scores have automatically executed steps (such as
dispensing specific volumes of sample/reagent, temperature monitoring, or
timing of steps); high scores require close monitoring or control, precise
temperatures or timing, accurate pipetting or extensive calculations.
Calibration,
Quality Control, and Proficiency Testing Materials – low scores have all
required reagents, controls and PT material commercially available and products
are stable.
Test
System Troubleshooting & Equipment Maintenance – low scores have automatic
troubleshooting or self-correction of errors (failed internal QC will
automatically repeat), or requires minimal judgement. Equipment maintenance
will be performed by the manufacturer or is minimal and easily performed,
whereas high scores require decision-making and direct intervention to resolve
most issues, or maintenance tasks require special skills and abilities.
Interpretation
& Judgement – low scores require minimal interpretation and judgement for
resolution of problems or determination of test results.
Low
scores indicate low complexity, with tests obtaining a total score of ≤12 being
categorized as moderate complexity. Tests with final scores >12 are
categorized as high complexity.
PPM: Within the category of nonwaived
tests is a subcategory referred to as Provider Performed Microscopy (PPM).
These are tests that are performed directly by a clinician during a patient
visit, and require the use of a microscope limited to bright-field or
phase-contrast microscopy. Based on the nature of the sample obtained, testing
must be performed immediately at the time of collection as delays could
compromise the accuracy of test results. As controls are typically not
commercially available for these tests, the testing is restricted to clinicians
only as knowledge and judgment is required to confirm testing accuracy and
correlation to the clinical presentation.
Tests
allowed under a PPM certificate are mostly related to OB/GYN procedures, with a
full list available through CMS here:
So the
next time you receive a request to add a new test at your laboratory, you’ll be
armed with a fairly long list of the requirements that come with that test
based on its complexity. Coming up next month we’ll discuss the difference
between laboratory certification and accreditation, along with the benefits of
obtaining accreditation for your lab.
-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.
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
emergency type.
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
pandemics arise.
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
occurs.
–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.
Everyone
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.
CLIA
CLIA
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.
These
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.
In
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.
There are
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.
CMS
The
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:
Issuing
laboratory certificates
Collecting
user fees
Conducting
inspections and enforcing regulatory compliance
Approving
private accreditation organizations (such as CAP) for performing inspections,
and approves state exemptions
Monitoring
laboratory performance on Proficiency Testing (PT) and approving PT programs
Publishing
CLIA rules and regulations
FDA
The Food
& 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:
Categorize
tests based on complexity
Review
requests for Waiver by Application from manufacturers
Develop
rules/guidance for CLIA complexity categorization
CDC
The Center
for Disease Control and Prevention (CDC) responsibilities include the following
tasks:
Provide
analysis, research, and technical assistance
Develop
technical standards and laboratory practice guidelines, including standards and
guidelines for cytology
Conduct
laboratory quality improvement studies
Monitor
proficiency testing practices
Develop
and distribute professional information and educational resources
Manage
the Clinical Laboratory Improvement Advisory Committee (CLIAC)
To
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.
Coming
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.
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
involved.
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.
Biological
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
handle them.
–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.
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
gender diversity.
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
built around.
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
medication.
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.
References
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.
