In this issue: Focusing on POCT

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Professional certification in point-of-care testing

T. Scott Isbell1, Elaine Colwell2, Elizabeth L. Frank3, Brad S. Karon4,
Veronica Luzzi5, Lou Ann Wyer6
1
Department of Pathology, Division of Laboratory Medicine, Saint Louis University, U.S.A.
2
Department of Professional Education, American Association for Clinical Chemistry, U.S.A.
3
Department of Pathology, University of Utah Health, U.S.A.
4
Department of Laboratory Medicine and Pathology, Mayo Clinic Rochester, U.S.A.
5
TriCore Research Institute, U.S.A.
6
Sentara Healthcare, U.S.A.

ARTICLE INFO ABSTRACT

Corresponding author: Professional certification is affirmation and docu-

T. Scott Isbell PhD, DABCC, FAACC mentation that the certified individual has the knowl-
Division of Laboratory Medicine
Department of Pathology edge, training, and skills necessary to practice some
Saint Louis University School of Medicine aspect of medicine or other profession. Herein is a
St. Louis, Missouri description of the genesis of a professional certifica-
United States
Phone: +1-314-977-4635 tion in point of care testing (POCT), inclusive of ra-
E-mail: [email protected] tionale and goals. A distinction between professional
Key words:
certification and certificate training programs is
quality assurance, professionalism, made. Details regarding eligibility to sit for the board
professional certification, standards exam are provided along with a list exam content ar-
eas. Finally, successes of this professional certifica-
tion program are highlighted.

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 T. Scott Isbell, Elaine Colwell, Elizabeth L. Frank, Brad S. Karon, Veronica Luzzi, Lou Ann Wyer
Professional certification in point-of-care testing

INTRODUCTION disease management programs incorporating

CLIA-waived POCTs (4).
Per recent market reports the size of the point-
of-care testing (POCT) sector is anticipated to
POCT TRAINING
reach USD 50.6 billion by 2025 up from USD
29.5 billion in 2020 (1). Demand remains high Training in the oversight and management of
for easy to use, portable technologies provid- POCT is variable. There is no standardized cur-
ing rapid results, that when properly integrat- riculum to teach principles of best practice in
ed into clinical workflows, have been shown point of care testing embedded within schools
to improve patient outcomes, increase health- of nursing, pharmacy or even medical laborato-
care provider and patient satisfaction and de- ry technology/clinical laboratory science. Much
crease cost (2). Point of care testing can be of training for many POCT personnel occurs on-
found throughout the hospital – in operating the-job. Certificate programs in POCT are avail-
rooms, the emergency department, intensive able to supplement or learn about POCT. These
care units, and the general medical wards. programs include but may not be limited to the
POCT devices have proven useful in the field AACC POC Specialist Program (elaborated more
as tools to assess patients during transport to below), a Pharmacy-based Point-of-Care Testing
hospital within ambulance and helicopters. Certificate Program from the NCPA launched in
They are found in long term care facilities and February 2021, a Point-of-Care Testing (POCT)
are often used to make transfer of care deci- Specialist REACH Certificate Course from the
sions. The personnel operating these devices American Medical Technologists association
usually are not laboratory medicine profes- and the Community Pharmacy-based Point-
sionals trained in clinical laboratory science of-Care Testing Certificate Program from the
but rather other healthcare professionals such National Association of Chain Drug Stores
as nurses, respiratory therapists, and medical (NACD). Based on a review of publicly available
assistants. In the U.S.A., pharmacists can be course learning objectives the certificate pro-
added to this list, given the expansion of POCT grams offered by laboratory medicine based
in community/retail pharmacy settings. Per the associations are focused primarily on quality
U.S.A based National Community Pharmacists
management and the administration of point of
Association (NCPA),
care testing programs while pharmacy associa-
Point-of-care testing provides an excellent tion certificate programs, having some overlap,
opportunity for community pharmacies appear to be focused more on the clinical ap-
to enhance revenue by expanding patient plication of POCT in a pharmacy setting and in-
care services while improving health at the clude such topics as assessment of clinical signs
patient and population levels (3). and symptoms of common infectious diseases
(e.g. influenza, group A Streptococcal disease)
Community pharmacies offer an attractive alter- and the performance of physical assessments
native to the emergency department for minor (e.g. cervical lymph node examination, oxygen
acute illnesses, especially given their abundant
saturation, body temperature).
locations and expanded hours. For more infor-
mation of one example, I point you to a recent
POC SPECIALIST CERTIFICATE PROGRAM
review in the Journal of Clinical Microbiology
by S. R. Herbin, D. G. Klepser, and M. E. Klepser Recognizing early a gap in POCT education,
on the subject of pharmacy-based infectious AACC in collaboration with the Critical and

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 T. Scott Isbell, Elaine Colwell, Elizabeth L. Frank, Brad S. Karon, Veronica Luzzi, Lou Ann Wyer
Professional certification in point-of-care testing

POCT Division (CPOCT) of the AACC launched in knowledge which can then be applied in daily
2008, a Point-of-Care (POC) Specialist Certificate practice. Successful completion is determined
Program - an assessment-based online course, by the participant achieving an accomplish-
consisting of eight learning modules covering ment, signified by the provision of an official
topics including: regulations, quality manage- document, i.e., certificate by an authoritative
ment, policies/procedures, instrument selec- body, in this case AACC. From an educational
tion/validation, connectivity/information tech- perspective, this is akin to certificate programs
nology (IT), education/training, administration, granted by institutes of higher education (i.e.,
and communication (5). Upon completion of the the authority) where there are requirements
online modules, participants are administered and standards (i.e., learning objectives and as-
an examination to assess their learning and are sessments) that must be satisfied.
provided a certificate of successful completion.
Professional certification is the affirmation and
To date, 1733 individuals have completed this
documentation that the certified individual has
professional development certificate program.
met predetermined standards of knowledge,
Future versions of this course may be expanded
training, and skills deemed necessary to practice
to include international regulatory standards
such ISO 15189 (Medical Laboratories) and ISO some aspect of medicine or other profession.
22870 (Point of Care Testing) thus providing Professional certifications are administered by a
professional development course with an even governing body, or board, of relevant stakehold-
broader worldwide application. ers – often practitioners who themselves have
demonstrated an elevated level of learning and
ASSESSMENT BASED CERTIFICATE competency and are normally certified by the
PROGRAMS VS. PROFESSIONAL very board they serve on. These boards are le-
CERTIFICATION gally or administratively autonomous from oth-
er entities and responsible for all essential de-
It is important to mark the distinction between cisions related to the certification activities (6).
professional certification and a course which In the medical field, certifications often become
yields a certificate. Many professional educa- requirements to practice, individuals are said to
tion courses offer a certificate of attendance: a be “board certified.” Examples of U.S.A. profes-
record that an individual attended the program. sional certification boards within the specialty
A certificate of attendance does not reflect of laboratory medicine include but are not lim-
whether an individual has successfully com- ited to, the American Board of Clinical Chemistry
pleted the program. Assessment-based certifi- (ABCC), the American Board of Pathology (ABP),
cate programs recognize when a participant has the American Board of Medical Microbiology
successfully participated in and completed the (ABMM). American Society for Clinical Pathology
intended education and training objectives (6). (ASCP) Board of Certification, American Medical
The AACC POC Specialist Program, for example, Technologists (AMT), and the American Board of
is an assessment-based certificate program. This Medical Genetics and Genomics (ABMGG).
educational, professional development course
has specific learning outcomes that a partici- CREATION OF A PROFESSIONAL
pant must prove they have accomplished to be
CERTIFICATION IN POCT
awarded a certificate. The purpose of this pro-
gram is to provide education and training to be Given the opportunity and position to lead, the
more knowledgeable about POCT applications, continued and predicted growth of POCT, along

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 T. Scott Isbell, Elaine Colwell, Elizabeth L. Frank, Brad S. Karon, Veronica Luzzi, Lou Ann Wyer
Professional certification in point-of-care testing

with the need to set professional standards, in assessments or testing. This partnership was
AACC made the establishment of a professional crucial to ensure an accurate and valid assess-
board certification in POCT one of its strategic ment was developed. (Table 1 and Table 2)
priorities. In 2017, AACC formed a task force for Following the development of the certification
the development of a professional certification exam an AACC POCT Professional Certification
examination to assess one’s applied knowledge Board was established to oversee all aspects of
and competencies in the field of POCT. The task the professional certification process from ap-
force was populated by individuals with exper- plication, to examination, scoring, and mainte-
tise in POCT with a range of educational back- nance of the exam item bank. Two of the mem-
grounds from bachelors to doctoral level (PhD), bers of the task force were selected to serve on
representing different perspectives (point of the inaugural board along with other well-rec-
care coordinator, medical directors of POCT, and ognized experts. See Figure 1 for organization
industry scientists). See Table 1. for list of task and initial population of the board. The goal
force members. In addition, the task force re- over time is that the AACC POCT Professional
lied on the extraordinary work of a larger group Certification Board will eventually be populated
of POCT experts to assist with exam develop- by those individuals that it has certified.
ment, see Table 2. The task force partnered Individuals that successfully meet eligibility re-
with professional psychometricians, individuals quirements and pass the certification exam are
who, per the U.S.A. based Psychometric Society, credentialed as Certified Point-of-Care Testing
are trained in the science of quantitative mea- Professionals, abbreviated as CPP, and are en-
surement practices in psychology, education, couraged to use this credential as a suffix fol-
and the social sciences. In other words, experts lowing their educational degree (7). (Figure 1)
Table 1 AACC Professional Certification exam development task force

Name Title Institution

T. Scott Isbell Medical Director, Clinical Saint Louis University School

PhD, DABCC, FAACC Chemistry and POCT of Medicine

Corinne Fantz Director, Scientific Affairs

Roche Diagnostic Corporation
PhD, DABCC, FAACC POCT

Kerstin Halverson, MS Clinical Applications Manager Instrumentation Laboratory

Karen Jenkins Emory University Hospital

Point of Care Coordinator
MT(ASCP) – Midtown

Peggy Mann Ambulatory POCC/Program University of Texas Medical

MS, MT(ASCP), CPP Manager Branch

Elaine Colwell Associate Director, American Association for

[ex-officio] Professional Education Clinical Chemistry

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Professional certification in point-of-care testing

Table 2 Professional Certification exam item writers

Name Institution

Adonica Wilson A. I. duPont Hospital for Children

Alan Wu University of California at San Francisco

Bob Kaplanis Laboratory Sciences of Arizona/Banner Health

Bradley Karon Mayo Clinic

Brenda Suh-Lailam Ann & Robert H. Lurie Children’s Hospital of Chicago

Charbel Abou-Diwan Nova Biomedical

Charlotte Bismark Dixie Regional Medical Center

Christine Cursio University Health Network

Christopher McCudden The Ottawa Hospital General Campus

Corrine Fantz Roche Diagnostic Corp.

David Kinninburgh Alberta Centre for Toxicology

Dawn Smith UNC Health Care

Joint Commission on Accreditation of Healthcare

Elia Mears
Organizations

Elizabeth L. Frank University of Utah and ARUP Laboratories

Gerald Kost University of California Davis

James Nichols Vanderbilt University Medical Center

The Ottawa Hospital University of Ottawa and Eastern

Julie Shaw
Ontario Regional Laboratories Association

Karen Jenkins Emory University Hospital Midtown

Kathleen David TriCore Reference Lab

Kerstin Halverson Instrumentation Laboratory

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Professional certification in point-of-care testing

Kim Skala Instrumentation Laboratory

Lilah Evans Thomas Jefferson University Hospital

Lou Ann Wyer Sentara Healthcare

LuAnn Hildebrand York Hospital

Marcia Zucker ZIVD LLC

Mark Kellogg Boston Children’s Hospital

Nam Tran University of California Davis

Nichole Korpi-Steiner University of North Carolina

Nicole Tolan Sciex Diagnostics

Octavia Peck-Palmer University of Pittsburgh Medical Center

Paul Yip University Health Network

Peggy Mann University of Texas Medical Branch

Rachel Edwards Texas Children’s Hospital

Robert Nerenz Dartmouth-Hitchcock Medical Center

T. Scott Isbell Saint Louis University School of Medicine

Sheila Cruthis Moses Cone Health System

Sonya Evans Greenville Health System

Veronica Luzzi TriCore Research Institute

William Clarke Johns Hopkins University School of Medicine

The Certified Point-of-Care Testing Professional education and training, instrument selection
(CPP) credential certifies individuals as profi- and validation/verification, connectivity and
cient in point-of-care testing. information technology, leadership and com-
The credential is evidence that the individual munication, specimen types, policies and proce-
has demonstrated competency in U.S.A. regu- dures, clinical applications, and technology and
lations and compliance, quality management, methodology.

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Professional certification in point-of-care testing

Figure 1 Inaugural AACC POCT Professional Certification Board

The first ever professional certification exam This could include laboratory managers, nursing
in POCT was administered by the board in managers, point-of-care coordinators, respira-
November 2018. The exam has been admin- tory therapists, pharmacists, pharmacy practi-
istered twice a year in the spring and the fall tioners, and physician assistants. Professional
since 2019. To date sixty-nine individuals have certification is a visible way to let colleagues, in-
met the requirements of the board, successfully stitutions, and your patients know that you are
passed the certification exam, and attained CPP competent practitioner of POCT. While there is
certification. a focus on the application of U.S.A. regulatory/
compliance knowledge, this does not preclude
REQUIREMENTS TO SIT FOR THE EXAM international applications, all who meet the eli-
gibility criteria will be considered.
Who is a candidate for POCT professional cer-
tification? Professional certification is geared To be eligible for the CPP credential, you must
towards those individuals who have significant have either a four-year degree in a biological,
responsibility related to point-of-care device chemical, physical, or medical laboratory sci-
selection and validation, quality management, ence or in nursing and at least two years of
operator training, regulatory compliance, and direct work experience in point-of-care test-
overall management of a point of care program. ing. Alternatively, individuals with a two-year

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Professional certification in point-of-care testing

degree in medical laboratory science or medical national and international boards and commit-
laboratory technology and four years of direct tees concerned with best practice in POCT.
work experience in point-of-care testing will
be considered. Interested applicants can find REFERENCES
eligibility requirements and apply for certifica- 1. Point of Care/Rapid Diagnostics Market by Product
tion at www.aacc.org/cpp. Applications to sit (Glucose, Infectious Disease (Hepatitis C, Influenza), Co-
for the board exam are reviewed by the POCT agulation), Platform (Microfluidics, Immunoassay), Mode
of Purchase (Prescription, OTC), Enduser (Hospital, e-
Professional Certification Board’s Credentials comm, Home Care) - Global Forecast to 2025. Markets
Committee. For detailed information please and Markets Report. February, 2021.
refer to the AACC Point-of-Care Professional 2. Price CP. Point of care testing. BMJ. 2001;322(7297):1285-
Certification – Procedures for Examination and 1288. doi:10.1136/bmj.322.7297.1285
Certification handbook (8). 3. Point of Care Testing. National Community Pharmacists
Association (NCPA). https://ncpa.org/point-care-poc-test-
LOOKING TO THE FUTURE ing Accessed March 27. 2021.
4. Herbin, S. R., et al. (2020). “Pharmacy-Based Infec-
It is one of the goals of the POCT Professional tious Disease Management Programs Incorporating
Certification Board that as the number of in- CLIA-Waived Point-of-Care Tests.” J Clin Microbiol 58(5):
e00726-00719.
dividuals credentialed as a CPP grows so does
their potential for greater leadership oppor- 5. AACC POC Specialist Certificate Program. https://
www.aacc.org/education/online-certificate-programs/
tunities, greater job secur ity, and higher pay. certificate-programs/point-of-care-specialist-certificate-
Testimonials from recently certified individuals program
are indicating this to be true. Darlene Paskovics, 6. Institute for Credentialling Excellence. Defining Fea-
CPP notes, “my CPP allowed me to advance to a tures of Quality Certification and Assessment-Based Cer-
leadership position and apply my knowledge to tificate Programs. Washington, DC: Institute for Creden-
tialing Excellence, 2010.
a diverse group of testing platforms,” and Christa
Williams, CPP states, “achieving my CPP desig- 7. AACC Launches Point-of-Care Professional Certification.
CLN. 2018 https://www.aacc.org/media/press-release-
nation has given me an edge in my field and will archive/2018/08-aug/aacc-launches-point-of-care-
open new career opportunities.” Metrics of suc- professional-certification
cess for this professional certification program, 8. AACC Point-of-Care Professional Certification – Proce-
will be the observation of increased numbers of dures for Examination and Certification. https://www.
CPPs providing technical and quality direction aacc.org/-/media/Files/Education-and-Career/POC-Cer-
tification-Test/AACC-PointofCare-Professional-Certifica-
for POCTs, writing practice guidelines, advanc- tion-Candidate-Handbook_08012019.pdf?la=en&hash=3
ing the field through research, and serving on D239915B1011E36FFBF8E4B046131FFAA55CF05

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