Download Point-of-care testing for infectious diseases

TOOLS FOR ADVANCING PHARMACY PRACTICE
Point-of-care testing for infectious
diseases: Opportunities, barriers, and
considerations in community pharmacy
Paul O. Gubbins, Michael E. Klepser, Allison M. Dering-Anderson, Karri A. Bauer, Kristin M. Darin,
Stephanie Klepser, Kathryn R. Matthias, and Kimberly Scarsi
Received August 13, 2013, and in revised
form September 30, 2013. Accepted for
publication September 30, 2013.
Abstract
Objectives: To identify opportunities to perform point-of-care (POC) testing and/or screening for infectious diseases in community pharmacies, provide an overview of such tests and how they are used in current practice,
discuss how the Clinical Laboratory Improvement Amendments of 1988
(CLIA) affect pharmacists performing POC testing, and identify and discuss
barriers and provide recommendations for those wanting to establish POC
testing for infectious diseases services in community pharmacies.
Data sources: PubMed and Google Scholar were searched from November
2012 through May 2013 and encompassed the years 2000 and beyond for the
narrative review section of this article using the search terms rapid diagnostic
tests, POC testing and infectious diseases, pharmacy services, CLIA waiver, and
collaborative drug therapy management. All state boards of pharmacy in the
United States were contacted and their regulatory and legislative websites
accessed in 2012 and January 2013 to review relevant pharmacy practice
laws.
Data synthesis: POC testing for infectious diseases represents a significant
opportunity to expand services in community pharmacies. Pharmacist education and training are addressing knowledge deficits in good laboratory
practices and test performance and interpretation. Federal regulations do
not define the qualifications for those who perform CLIA-waived tests, yet
few pharmacists perform such services. Fewer than 20% of states address
POC testing in their statutes and regulations governing pharmacy.
Conclusion: POC testing for infectious diseases could benefit patients and
society and represents an opportunity to expand pharmacy services in community pharmacies. Existing barriers to the implementation of such services
in community pharmacies, including deficits in pharmacist training and education along with state regulatory and legislative variance and vagueness
in statutes governing pharmacy, are not insurmountable.
Keywords: Rapid diagnostic tests, Clinical Laboratory Improvement
Amendments, collaborative practice, pharmacy services, laws and legislation.
J Am Pharm Assoc. 2014;54:163–171.
doi: 10.1331/JAPhA.2014.13167
Paul O. Gubbins, PharmD, FCCP, is Professor and Associate Dean, University of
Missouri–Kansas City School of Pharmacy
at Missouri State University, Springfield.
Michael E. Klepser, PharmD, FCCP, is
Professor, Department of Pharmacy Practice, College of Pharmacy, Ferris State
University, Kalamazoo, MI. Allison M.
Dering-Anderson, PharmD, is Clinical Assistant Professor, Department of Pharmacy
Practice, College of Pharmacy, University
of Nebraska Medical Center, Omaha. Karri
A. Bauer, PharmD, BCPS, is Specialty
Practice Pharmacist, Infectious Diseases,
Ohio State University Medical Center,
Columbus. Kristin M. Darin, PharmD,
BCPS, is Research Assistant Professor
in Medicine–Infectious Diseases, Center
for Global Health, Northwestern University
Feinberg School of Medicine, Chicago, IL.
Stephanie Klepser, PharmD, is Director
of Clinical Services, Kalamazoo Center for
Medical Studies Pharmacy, Kalamazoo,
MI. Kathryn R. Matthias, PharmD, BCPS
(AQ-ID), is Assistant Professor, Pharmacy
Practice & Science, College of Pharmacy,
University of Arizona, Tucson. Kimberly
Scarsi, PharmD, MS, BCPS, is Associate
Professor, Pharmacy Practice, College of
Pharmacy, University of Nebraska Medical
Center, Omaha.
Corresponding Author: Paul O. Gubbins,
PharmD, FCCP, Professor and Associate
Dean, University of Missouri–Kansas City
School of Pharmacy at Missouri State University, 327 West Mill Street, #425, Springfield, MO 65806. Fax: (816) 235–5190. Email: [email protected]
Disclosure: Drs. M. Klepser and DeringAnderson have developed a Certificate
Program for Community Pharmacists interested in performing point-of-care testing
and/or screening for infectious diseases in
a community pharmacy. Drs. Gubbins, M.
Klepser, Bauer, Darin, S. Klepser, Matthias,
and Scarsi were members of the Society
of Infectious Diseases Pharmacists Rapid
Diagnostic Testing in Infectious Diseases
Task Force.
Acknowledgments: To the Society of Infectious Diseases Pharmacists Board of
Directors for their review and approval of
this work; to Justin Kuhns, Danny Anderson, and Eric Hackbarth for assistance in
contacting state boards of pharmacy for this
paper.
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POINT-OF-CARE TESTING FOR INFECTIOUS DISEASES
P
oint-of-care (POC) tests can potentially improve the
detection and management of infectious diseases by
reducing the time between testing for and the diagnosis
of an infection. Rapidly diagnosing an infection benefits
the patient by facilitating timely access to care and initiation of therapy; it may also benefit the population at
large by reducing the probability of disease transmission.1 Furthermore, rapidly identifying the cause of an
infection and promptly initiating appropriate therapy
may reduce inappropriate antimicrobial use in the community.2
Although no universally accepted definition of POC
testing exists, it typically involves performing a robust
diagnostic test outside of a laboratory at or near the patient that produces a reliable result rapidly to aid in disease screening, diagnosis, and/or patient monitoring.3–5
To improve clinical management (e.g., triage, referral,
and treatment decisions), such tests must be convenient
and simple to perform, and have a rapid turnaround of
results. With POC testing, the screening or diagnostic
At a Glance
Synopsis: Point-of-care (POC) testing for infectious diseases provides a unique opportunity for
community pharmacists to expand their patient
care services while also benefitting patients and
developing in the public health role of the profession, according to the authors of this Tools for
Advancing Pharmacy Practice article. Through a
literature review and research into state laws and
regulations, the authors determined that pharmacists in many states could apply for Clinical
Laboratory Improvement Amendments (CLIA)
waivers for POC testing and offer such testing for
common infectious diseases such as influenza,
group A streptococcal pharyngitis, human immunodeficiency virus, and hepatitis C virus. Existing
barriers to the implementation of POC testing services in community pharmacies, including deficits in pharmacist training and education along
with state regulatory and legislative variance and
vagueness in statutes governing pharmacy, are
not insurmountable.
Analysis: Challenges to the implementation of POC
testing for infectious diseases are not insurmountable
if pharmacists obtain the proper training, understand
their state regulations and statutes, and work with
regulators and stakeholders to ensure such services and
follow-up care are provided legally, safely, accurately
and efficiently. POC testing for infectious diseases has
many potential patient and population level benefits
and could expand community pharmacy’s patient care
service offerings.
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process can be completed during a single clinical encounter, a key difference from laboratory-based testing.
While being convenient, simple, and quick are important, these POC testing characteristics are meaningless if
the test result does not improve access to care, counseling, and/or patient outcomes.6
Community pharmacies represent an ideal setting to perform POC testing for infectious diseases.
POC tests for infectious diseases are waived under the
Clinical Laboratory Improvement Amendments of 1988
(CLIA). Pharmacists can charge patients directly or bill
third-party payers for services using these tests as they
would with other CLIA-waived POC tests. For a more
comprehensive discussion about establishing POCtesting services and pharmacist compensation for providing services, including CLIA-waived tests, in a community pharmacy, the reader is referred to two excellent
reviews on these topics.7,8
The purpose of this Tools for Advancing Pharmacy
Practice article is to identify opportunities to perform
POC testing and/or screening for infectious diseases in
a community pharmacy, provide an overview of POC
infectious disease tests and how they are used in current practice, and discuss how CLIA affects pharmacists
performing POC testing. We also identify and discuss
barriers community pharmacists may encounter when
establishing infectious disease POC-testing services and
provide recommendations for those considering implementation of such services.
POC-testing opportunities in community
pharmacies
In 2010, an estimated 274,900 pharmacists were practicing in the United States, and this figure is expected
to grow at least 25% by 2020.9 Nearly 200,000 pharmacists practice in the community setting in the United
States.10,11 By virtue of patient volume and diverse locations nationwide, community pharmacies are highly
visible health care facilities that are easily accessible to
the public without appointment.12,13 Despite their ubiquity, pharmacies are currently an underused health care
resource staffed with highly trained health care professionals.14
As community pharmacies continue to evolve toward a primary mission of provision of patient care services, the profession has a clear opportunity to expand
pharmacist services beyond medication dispensing and
patient counseling to encompass convenient, accessible,
and affordable primary care services.14 In fact, many
community pharmacies have expanded their services by
implementing on-site health care clinics or “retail clinics” that provide preventive health care services such as
health screenings, diagnostic services, and vaccinations,
as well as treatment for many common illnesses or complications.14 Given the knowledge, skills, and accessibility of community pharmacists, POC-testing services for
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infectious diseases represent a focused means through
which community pharmacies can expand their services
to improve the prevention and treatment of infectious
diseases.
Data demonstrate that community pharmacists and
pharmacies can significantly improve the prevention
and management of infectious diseases, such as influenza, herpes zoster, and streptococcal pharyngitis.15–18
Community pharmacists have become critical to population-based vaccination efforts. With their ubiquity,
community pharmacies are proven important elements
of efforts to reach populations that might otherwise go
unvaccinated (e.g., medically underserved, healthy
young and middle-aged adults).12,15–21
Performing POC testing for common infectious
diseases in community pharmacies could also produce
a significant societal benefit by lessening inappropriate antimicrobial use, reducing transmission of these
pathogens in the community, and improving the capacity to monitor population exposure to an infectious
agent (e.g., influenza). In addition to situations in which
pharmacists can initiate POC management (e.g., needleexchange programs for injection drug users, clinical services for chronic diseases), limited data have emerged
to suggest that community pharmacists’ screening for
diseases such as human immunodeficiency virus (HIV),
hepatitis C virus, and other communicable diseases of
public health interest could improve linkage to care and
have a positive impact on disease identification and outcomes.22,23
Overview of POC infectious disease
tests
POC tests for infectious diseases are based on a variety
of microbial particle-based or antibody-based detection
methods, including agglutination, enzyme-linked immunosorbence, optical immunoassays, or lateral flow
immunochromatography.24 Common POC tests for
infectious diseases can detect a variety of infections or
microorganisms from patient specimens. Although data
describing the use of POC tests for infectious diseases
are limited at this time, such tests can likely be incorporated into community pharmacy practice in two ways.
First, POC infectious disease tests can be used in
community pharmacies to screen for communicable diseases of public health interest. For example, performing
POC screening tests for HIV and hepatitis C virus can
improve linkage to appropriate care or counseling services for patients with reactive test results.25 Expanded
surveillance through the use of these tests may also provide more accurate data on disease prevalence as well as
increase public health agencies’ ability to reach targeted
populations for screening.1
For example, some pharmacies are performing POC
testing for influenza and group A streptococci and piloting work to augment public health efforts by reporting
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positive cases and outbreaks.25 A 2013 report by the National Association of County and City Health Officials
on partnerships between community pharmacies and
health departments recognized the potential for POC
testing for infectious diseases to improve data sharing
and facilitate collaboration that would inform disease
surveillance efforts.26
With the rapid changes now under way in available
technology, some equipment used for infectious disease
POC tests can store data and also facilitate data sharing
and communication with public health agencies. Using
these tests to screen for communicable diseases of public health interest could also extend antimicrobial stewardship activities to the community practice setting. For
example, having more accurate data on the prevalence
of influenza in the community could improve the allocation of vaccines to areas in highest need or help curtail
inappropriate use of antibacterial agents.2,26,27
A second way that POC infectious disease tests can
be used in community pharmacies is as an aid in the rapid
identification or diagnosis of treatable infectious diseases in
individual patients. For example, POC testing for influenza and group A streptococcal pharyngitis can yield information that rapidly leads to initiation of cost-effective
treatment.17,18
Overview of CLIA’s certificate of waiver
All facilities that conduct laboratory testing on human
specimens for health assessment, diagnosis, prevention,
or treatment of disease, including all POC tests, are regulated by the Centers for Medicare and Medicaid Services (CMS) through CLIA.28 Locations that perform only
CLIA-waived tests, including community pharmacies,
are considered “laboratories” and must obtain a CLIA
Certificate of Waiver before initiating testing services.
Requirements for a CLIA Certificate of Waiver vary
from state to state. State CMS offices are a resource from
which to gain specific information about obtaining and
maintaining a CLIA Certificate of Waiver. Information
on how to apply for a CLIA Certificate of Waiver can also be obtained from the CMS website at www.cms.hhs.
gov/clia.
The U.S. Food and Drug Administration (FDA) classifies laboratory tests into one of three categories based
on their level of complexity and potential for risk to public health.29 Waived tests are those defined as simple laboratory examinations and procedures that are cleared by
FDA for home use, use methodologies that are so simple
and accurate as to render the likelihood of erroneous
results negligible, or pose no reasonable risk of harm to
the patient if the test is performed incorrectly.29 CLIAwaived tests are available for 120 analytes. A complete
list of these can be accessed at www.accessdata.fda.
gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm.
Currently, 16 analytes are used in CLIA-waived
tests for infectious diseases, and not all of them have
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Table 1. CLIA-waived analytes for infectious diseases
Analyte
Aerobic/anaerobic organisms–vaginal
Intended use
Local (in tears of the eye) adenovirus detection
associated with acute infectious conjunctivitis
Detection of sialdase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp.,
and Mobiluncus spp. in vaginal fluid
Group A streptococcus
Aid in rapid diagnosis of group A streptococcal
infection
Throat swab
Helicobacter pylori and
Helicobacter pylori antibodies
Most aid in diagnosis of infection by H. pylori.
Some aid in presumptive identification of H.
pylori in gastric biopsy specimens from patients.
Whole blood
Aid in diagnosing HCV
Whole blood
Aid in the detection of HIV. Used for initial
screening. Tests detect either the HIV-1 antibody
or both the HIV-1 and HIV-2 antibodies
Whole blood, oral fluid
Aid in diagnosis of infectious mononucleosis
Whole blood
Adenovirus
Hepatitis C virus (HCV)
antibody
Human immunodeficiency virus (HIV) antibodies;
HIV-1 antibody; HIV-1
and HIV-2 antibodies
Infectious mononucleosis
antibodies
Influenza A, A/B, B
Lyme disease antibodies
(Borrelia burgdorferi
antibodies)
Respiratory syncytial
virus (RSV)
Trichomonas
Aid in rapid differential diagnosis of influenza A
and B viral infections
For qualitative presumptive detection of IgG
and IgM antibodies to B. burgdorferi in human
serum or blood
Aid in diagnosis of RSV infections in pediatric
patients
For qualitative detection of Trichomonas antigens in patients with symptoms or suspected
exposure
Required specimen
Tears
Vaginal fluid
Nasal swabs or washes
Whole blood
Nasal swabs or washes; nasopharyngeal
aspirate
Vaginal swab
Comments
Intended for use in an office, clinic, or
hospital.
Intended for use in an office, clinic, or hospital. Because of the means of specimen
collection, this test may not be appropriate
for all pharmacies.
Some tests are only intended for in-vitro
diagnostic use in clinical and physician
office laboratories.
Not all tests are suitable for use at point-ofcare testing sites.
Intended for use in public health settings,
physician office, community health clinic,
laboratories, and emergency departments.
Only one currently approved test is suitable
for in-home testing. Results from tests
from two different manufacturers can be
used to confirm HIV infection.
Tests are intended for point-of-care and
other use by health professionals.
Test could be performed in a community
pharmacy. Any follow-up of negative test
results by cell culture would require a
laboratory.
Intended for use in clinical and physician
office laboratories.
Negative test results should be confirmed
by cell culture.
Intended for use in clinical and physician
office laboratories.
Abbreviations used: HCV, hepatitis C virus; HIV, human immunodeficiency virus; RSV, respiratory syncytial virus; IgG and IgM, immunoglobulins G and M, respectively.
Source: Adapted in July 2013 from CLIA (Clinical Laboratory Improvement Amendments) Currently Waived Analytes, available on the website of the Food and Drug Administration, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm
tests that are intended for POC use (Table 1).
In the past decade, the number of pharmacies
with a certificate to offer CLIA-waived laboratory services increased nearly threefold, and the percentage of
waived facilities that are pharmacies increased from
2% to 5%.28,30 Although the reasons for these increases
have not been studied, the trend may reflect a need to
enhance nondispensing revenues to compensate for
declining prescription reimbursement rates, a means to
improve patient services and public image, or a way of
gaining a competitive advantage in the changing health
care delivery environment.31 Perhaps the successes observed with the expansion of clinical services in community pharmacy practice to include immunizations
have prompted pharmacists and health care systems to
explore a greater role in primary care.12
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Barriers to infectious disease POC
testing in community pharmacies
Lack of training
Although CLIA-waived POC tests are classified as simple to use with low risk for erroneous results, they are
not error-proof.29 Regardless of how POC infectious disease tests are used in the community pharmacy setting,
they should be performed only by trained individuals
and according to the manufacturer’s instructions. Studies by the Centers for Disease Control and Prevention
(CDC) and CMS indicate that, in general, CLIA-waived
sites (including pharmacies) usually take measures
to perform testing correctly. However, available data
raise quality-control concerns about practices that could
lead to errors in testing and adverse events.32 Specific
concerns include lack of understanding about good
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laboratory practices and inadequate training on how
to perform a test, the interpretation and knowledge of
test shortcomings, and requirements treatment, record
keeping, and disease reporting.28
While such deficits exist, current standards and proposed competencies for educating and training pharmacists have begun to address these gaps in knowledge.
The most recent Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading
to the Doctor of Pharmacy degree from the Accreditation Council for Pharmacy Education (ACPE), effective
in 2011, list diagnostic tests among the elements of the
science foundation about which pharmacy practitioners
should be knowledgeable and competent before receiving their degree.33
A joint National Association of Chain Drug Stores
(NACDS) Foundation–National Community Pharmacists Association–ACPE Task Force formulated practice
competencies for entry-level practitioners in 2012. These
require each entry-level graduate to be able to apply
public health policy in clinical situations and list specific objectives to “collect, interpret, and make recommendations based on the results of health and wellness
screenings and diagnostic tests” and “describe the need
for CLIA waiver and describe documentation of testing
done in the community pharmacy.”34
Regulatory variability and vagueness
The scope of practice for pharmacists varies among
states based on laws and board of pharmacy regulations. The actions of pharmacy and other health regulatory boards are subject to legislative and regulatory
oversight, and the political process adds to the variability in state statutes governing the practice of pharmacy.
Because of these legal realities, it remains unclear
from a national perspective which states may allow
pharmacists to provide POC tests for infectious diseases
and what role, if any, pharmacists may have in performing these services. Legislative and regulatory variability
and vagueness may produce confusion among practitioners and therefore presents a barrier to pharmacists
performing POC tests for infectious diseases in the community setting.
Interestingly, a national survey of 194 licensed pharmacists from 40 different states regarding their knowledge and perceptions of POC tests used for the identification of infectious diseases found that more than 85%
of respondents were unaware if their state practice acts
allow them to conduct such tests (unpublished data,
personal communication with Danielle Daunais, principal investigator).
Even if POC testing is addressed in the state statutes
and regulations governing the practice of pharmacy, individual provisions may lack specificity or be worded
vaguely. To evaluate the variability in the United States
with regards to such regulations, we assessed the scope
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of practice for all 50 states and the District of Columbia
by reviewing the websites of the boards of pharmacy
and/or contacting representatives of state boards of
pharmacy via e-mail. This review took place from January 2012 to January 2013. Only 8 (16%) states (California, Colorado, Delaware, Georgia, New Jersey, North
Dakota, Pennsylvania, and Washington) explicitly address POC testing in their respective pharmacy practice
acts, and in Maryland, it is addressed in the regulations
governing laboratories. In five of these eight states, the
practice act specifies POC tests that pharmacists are allowed to perform.
If the practice act of a state does not explicitly address POC testing directly, such tests may be addressed
under collaborative drug therapy management (CDTM)
provisions in state regulations or statutes. At the start of
2012, according to the National Association of Boards of
Pharmacy Survey of Pharmacy Law, 43 states had some
form of CDTM provisions in their regulations or statutes. In late 2012, Missouri became the 44th state to have
such provisions, leaving Alabama, Delaware, the District of Columbia, Illinois, Kansas, Oklahoma, and South
Carolina as the only states without enabling CDTM
provisions.35 In 19 of these 44 states (42%) (Arkansas,
California, Colorado, Georgia, Idaho, Iowa, Louisiana,
Maryland, Michigan, Montana, New Jersey, Nebraska,
New Mexico, North Dakota, Oregon, Texas, Vermont,
Washington, and Wyoming), the CDTM provisions explicitly state that pharmacists are allowed to perform
POC testing. One other state, Pennsylvania, specifically
allows pharmacists in institutional practice settings to
order laboratory tests and order and perform other diagnostic tests needed to manage drug therapy with a
CDTM protocol as long as such activities are consistent
with the standards of the institution. The CDTM provisions in Pennsylvania are silent on whether pharmacists in the community setting could engage in similar
practices. In 7 of these 19 states, POC testing is also addressed in pharmacy practice acts: California, Colorado,
Georgia, New Jersey, North Dakota, Pennsylvania, and
Washington.
The variability in how POC testing is addressed in
state statutes and regulations governing the practice of
pharmacy is not surprising, given that the regulatory
oversight for CLIA and its Certificate of Waiver program is a responsibility of state agencies or departments
other than state boards of pharmacy.
Limited implementation of services
Without more widespread implementation of community pharmacy services involving POC tests for infectious diseases, individual efforts to establish such services may be stifled because stakeholders will likely continue to fail to recognize their potential benefits and value.
CLIA does not define the professional qualifications for
the director or testing personnel at waived sites.29
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Table 2. Checklist of resources for community pharmacists considering offering infectious disease point-of-care testing services
❚❚ Obtain education and training on CLIA waivers and performance of
waived tests.
ŽŽ Attend continuous professional development programs.
❚❚ Be familiar with local statutes and regulations governing pharmacy
practice and CDTM agreements.
ŽŽ Review pharmacy practice act and state board rules and regulations.
❚❚ Be familiar with other state and federal regulations.
ŽŽ CLIA regulations (www.cms.gov) and regional or state CMS office
ŽŽ Occupational Safety and Health Administration regulations for
health care workers and needlestick precautions (www.osha.gov)
ŽŽ Centers for Disease Control and Prevention28
❚❚ Develop standard operating procedures that address documentation
of testing and follow-up of test results.
ŽŽ Centers for Disease Control and Prevention28
❚❚ Consider partnering with stakeholders to pilot services.
ŽŽ National Association of County and City Health Officials
(www.naccho.org)26
ŽŽ State professional organizations, state agencies, nonprofit and/or
nongovernmental quality improvement organizations
❚❚ Check liability insurance.
Abbreviations used: CLIA, Clinical Laboratory Improvements Amendments;
CDTM, collaborative drug therapy management; CMS, Centers for Medicare and
Medicaid Services; MMWR, Morbidity and Mortality Weekly Report.
Data indicate that these tests are not commonly
being performed in pharmacies or by pharmacists. In
2002–04, a national survey with 3,788 respondents indicated that the majority (86%) of the directors of their
CLIA-waived sites were either physicians or nurses. The
other 14% of site directors had a variety of medical or
nonmedical training, including some with only a general educational development (GED; high school equivalency) degree. Only 76 (2%) respondents indicated the
directors of CLIA-waived sites were pharmacists.28
In a CMS study, 5,511 respondents provided information about the professional training of the individuals who performed the testing at their CLIA-waived
site. The top four categories were nurses (46%), medical assistants (25%), physicians (9%), and high school
graduates or persons with a GED (7%). Only 55 (1%) respondents indicated the testing personnel at their CLIAwaived sites were pharmacists. According to data from
2004, only 3,294 (3%) of the 109,820 CLIA-waived sites
were identified as pharmacies.28
Currently, an estimated 64,000 community pharmacies are operating in the United States; data indicate that
8,856 (14%) of all community pharmacies have a CLIA
Certificate of Waiver.8,9,30 Given the minority of community pharmacies possessing a CLIA Certificate of Waiver, and the small number of pharmacists identified in the
past as being directors of CLIA-waived sites or even as
testing personnel, the potential for pharmacies to offer
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such services or for pharmacists to provide these tests
has clearly not been realized.
Recommendations for pharmacy-based
POC testing for infectious diseases
Based upon the opportunities and barriers identified
above and after considering sound business planning
practices, we believe pharmacists should consider the
following when contemplating whether to establish services for POC testing for infectious diseases in community pharmacies (Table 2).
Obtain education and training
In late 2005, CDC published a report that provided
recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting
quality waived testing. These recommendations include
considerations before introducing waived testing, including outlining the management responsibility for
testing, regulatory, safety, physical, and environmental
requirements along with determining how the tests will
benefit care offered at the testing site and the associated
costs, staffing, and documentation.
The recommendations provide good laboratory
practices to follow at each testing phase: before (e.g.,
test ordering and specimen collection), during (e.g., control testing, test performance, result interpretation and
recording), and after (e.g., result reporting, documentation, confirmatory testing, and biohazard waste disposal). These recommendations can be used to form the
basis of standard operating procedures for the testing
facility. Overall, the recommendations are intended for
those who would benefit from improving their knowledge of good laboratory practices.28
Pharmacists considering implementing POC infectious disease testing need to ensure that patients receive
appropriate post-test follow-up or counseling services.
For this reason, pharmacists performing POC infectious
disease testing should possess adequate training in infectious diseases or collaborate with another infectious
disease-credentialed health care professional. Pharmacists should also be adequately trained on the performance and interpretation of waived tests.
In addition to these recommendations, faculty from
the colleges of pharmacy at University of Nebraska
Medical Center and Ferris State University (including
authors MEK and AMD) have collaborated to develop
an ACPE-approved professional development certificate program to provide pharmacists with exposure to
the practice skills and policy requirements necessary to
safely and effectively incorporate POC testing into their
clinical practice. This program has been endorsed by the
Society of Infectious Diseases Pharmacists and NACDS.
The program is managed by the Michigan Pharmacists
Association.
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Review governance of pharmacy practice and
CDTMs
The lack of reference to CLIA-waived POC testing in
state regulations and statutes governing pharmacy
practice does not preclude pharmacists from performing these tests; rather, permission for testing is granted
by CMS through issuance of CLIA Certificates of Waiver. The process of applying for and maintaining a CLIA
waiver is not difficult. In general, it involves completing
a standard form (CMS-116), which can be obtained from
the CMS website (www.cms.gov). Once completed, the
form must be sent to the applicable state agency, which
will process it and issue a fee remittance coupon listing
the CLIA identification number and the amount due
for the certificate. The process takes approximately 2–3
months.8 The waiver is renewed by fee every 2 years.
Pharmacists performing POC testing in community
pharmacies must ensure that the pharmacy has a valid
CLIA waiver just as they would look for a valid pharmacy license. Although pharmacists practicing in CLIAwaived pharmacies do not need board of pharmacy permission to perform a POC test, it would be prudent to
check local statutes and regulations to determine what,
if any, additional approvals are needed, such as CDTM
agreements or exemptions from other state agencies
governing laboratory practices.
Often the vagueness of state statutes and regulations
governing the practice of pharmacy regarding POC testing in community pharmacies may be addressed by specifically including the performance and interpretation of
such tests in a CDTM agreement with a licensed physician or other licensed diagnostician. For example, the
ability of the pharmacist to render a professional opinion about a POC test result likely depends on the scope
of practice defined by individual state regulations and
statutes governing pharmacy practice. Thus, before developing services to provide POC testing for infectious
diseases in a community pharmacy, pharmacists must
understand what their state regulations and statutes
governing pharmacy practice allow with regard to test
result interpretation and application to clinical care.
In many cases, such actions may be allowed under
the CDTM provisions of state regulations and statutes
governing pharmacy practice. However, CDTM regulations vary in scope across states and still do not exist in a few states.35 In our examination of the scope of
practice of all 50 states and the District of Columbia, 12
states with CDTM provisions did not allow pharmacists
to perform POC testing (Connecticut, Hawaii, Indiana,
Kentucky, Maine, Massachusetts, New York, North Carolina, Ohio, Rhode Island, Utah, and Virginia). Therefore, in states with very limited or no CDTM provisions
in their statutes and regulations governing the practice
of pharmacy, community pharmacies may not be able
to offer such services unless POC testing is explicitly addressed in their respective pharmacy practice acts.
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Develop follow-up and documentation procedures
Performing POC testing for infectious diseases in the
community pharmacy setting will be meaningless to
the patient and wasteful for the health care system if a
follow-up plan to address the test result is not included
as part of standard operating procedures. Because of the
variability in CDTM provisions that exists across the
United States, pharmacists must understand their state
regulations and statutes to determine how to legally
and efficiently provide follow-up care as a result of performing POC tests for infectious diseases. In some cases,
follow-up may be mandated as a necessary element of
a CDTM agreement and allow for follow-up of specific
diseases in any patient, while in other states CDTM regulations may require issuance of a prescription for each
patient.
Consider partnering with stakeholders to pilot services
State boards of pharmacy and legislative bodies often require data and experience to expand the scope of practice.
While gaining regulatory support and endorsement is
ultimately vital to changes in practice, it is not the starting point. Rather, pharmacy demonstration projects in
collaboration with physicians and other stakeholders,
such as third-party payers and patients, may be needed
to advance practice and expand services to include POC
testing for infectious diseases in community pharmacies.
To ensure such efforts are productive, state boards of
pharmacy and other state regulators must be involved.
Check for liability insurance
Pharmacists planning on providing POC testing for infectious diseases under a CDTM must understand that
they will incur more liability. Depending on how the
CDTM is structured, the collaborating physician is generally not liable for the actions of the pharmacist, just as
they are not liable for the pharmacist’s action in the administration of a vaccine or the dispensing of a prescription. In addition to understanding state regulations, the
pharmacist should also contact their liability insurance
carrier to determine whether an individual or pharmacy policy covers performing and/or interpreting POC
tests.
In doing so, pharmacists must understand that insurance companies cannot insure an illegal activity.
Even if an activity is legal, a given carrier still may not
underwrite it. Thus, pharmacists may need to involve
their state board of pharmacy representative in discussions with their insurance representative so that the
company has a full understanding of and is comfortable
with the proposed practice.
Conclusion
POC testing for infectious diseases has many potential
patient and population-level benefits. Offering such serj apha.org
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POINT-OF-CARE TESTING FOR INFECTIOUS DISEASES
vices in a community pharmacy represents an opportunity to expand pharmacy services beyond medication
dispensing and patient counseling to encompass convenient, accessible, and affordable primary care services.
Challenges facing the widespread implementation of
POC testing for infectious diseases in community pharmacies include deficits in pharmacist training and education and the variance and vagueness in state statutes
and regulations governing the practice of pharmacy.
However, these challenges are not insurmountable if
pharmacists obtain proper training, understand their
state regulations and statutes, and work with regulators and stakeholders to ensure that such services and
follow-up care are provided legally, safely, accurately,
and efficiently.
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