Getting to the Point: Finger-Stick Testing in
Pharmacy Practice
September 7, 2013
Peter Kim, PharmD
PGY1 Community Pharmacy Resident
University of New England
Martin’s Point Health Care
At the end of this presentation, the
learner should be able to:
• Discuss point-of-care testing and current opportunities within
pharmacy practice
• Describe what a CLIA waiver is and how to obtain one
• Identify CLIA waived tests that have been approved in Maine
• Discuss the impact point-of-care testing has on pharmacy practice
• Given a complex patient case, assess which CLIA waived tests may
be done at the pharmacy
Background
• Expansion of pharmacy practice
– ASHP Statement on the Pharmacist’s Role in Primary Care
(1999)
– ASHP statement on role of health-system pharmacists in
public health (2008)
– RADM Scott Giberson “A Report to the US Surgeon General
2011”
• Development of point-of-care testing
– Establishing a Pharmacy-Based Laboratory Service (2000)
– Point-of-care testing: an introduction (2004)
Point-of-care Testing
Point-of-care testing
• Diagnostic testing performed at or near the
site of patient care
• It is a supplement to, not a replacement for,
central laboratory testing
• The test is convenient and immediate for the
patient
General applications
• Screening
– Identifies persons at high risk for disease
– Screening events
• Disease/drug monitoring
– Determines efficacy of therapy
– Used with patients already diagnosed with a disease
• Diagnosing
– Determines presence of a disease (not a function of
pharmacists)
Opportunities
• Outpatient
– Community pharmacy
– Ambulatory care
• Inpatient
– Emergency medicine
– Critical care
Common Tests
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Outpatient
Blood glucose
Cholesterol
AST/ALT
Pregnancy
HIV
STDs
Drug
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Inpatient
Cardiac Markers
INR
CBC
HLA Typing
Hepatitis C
Legal and Regulatory
Requirements
Legal and Regulatory Requirements
• Basic OSHA and CLIA-waive standards
• These regulations differ from those governing
other typical pharmacy activities
Maine legislature
• Maine BOP has recognized point of care
testing to be within the scope of pharmacy
practice
• Awaiting release of official wording of rules
and regulations
OSHA
• Occupational Safety and Health
Administration
• Develops and enforces workplace safety and
health regulations
• Created to save lives, prevent injuries, and
protect the health of America’s workers
https://www.osha.gov/law-regs.html
OSHA regulations
• Performing laboratory tests
• Consistent use of personal protective
equipment
• Safe procedures
CLIA
• Clinical Laboratory Improvement Amendments
• Passed by Congress in 1988
• Established quality standards for laboratory testing
• Ensures accuracy, reliability, and timeliness
• Final regulations published in Federal Register on
February 28, 1992
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124202.htm
CLIA Waived Tests
• Simple laboratory examinations and procedures
• Insignificant risk of an erroneous result
• Tests that meet risk, error, and complexity
requirements are issued a CLIA certificate of waiver
• November 2007 – CLIA waiver provisions revised by
Congress to make it clear that tests approved by the
FDA for home use automatically qualify for CLIA waiver
Blood Glucose
• Bayer A1CNow
• Bayer Contour Blood Glucose System
Images taken from www.cliawaived.com
Cholesterol
• CardioChek Analyzer
• Cholestech LDX Lipid Profile
Images taken from www.cliawaived.com
Pregnancy Tests
• Pregnancy Urine Cassette Test
• Clinitest hCG Pregnancy Test
Images taken from www.cliawaived.com
HIV/HCV
• Oraquick ADV HIV 1-2 Rapid Test Kit
• Oraquick HCV Rapid Antibody Test
Images taken from www.cliawaived.com
Obtaining a Certificate of Waiver
• Go to:
http://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/How_to_Apply_for_a_C
LIA_Certificate_International_Laboratories.html
• Scroll down to “Related Links”
• Click “CMS 116 PDF”
Obtaining a Certificate of Waiver
• Fill out the CMS-116 form and send to the State
Survey Agency
– Information provided at the end of the presentation
• Biennial Certificate Fee of $150
• To maintain CLIA license, you must agree to
announced inspections by CMS
– The purpose is to ensure the quality of the point-ofcare testing conducted in each laboratory
Establishing a CLIA waived site
Location
• Clean, stable, level workspace
• Patient confidentiality
• Temperature/humidity
• Utilities
• Safe waste disposal
http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf
Personnel
• Required personnel
• Able to demonstrate competency
• Employee training
http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf
Testing Equipment
• Know how to use the test
• Are there reagents needed?
• Temperatures of refrigerators and storage
areas
• Lot numbers of kits and reagents
http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf
Other requirements
• Recordkeeping
• Exposure control plan
• In Maine, you need a Health Screening Permit
What happens in emergencies?
• Be prepared!
• Supplies you should have on hand
– Make a kit
• Smelling salts
• Bandages
• Ice pack
Point-of-care Program
Incorporation
CDTM and MTM
• Collaborative Drug Therapy Management
– Initiating, monitoring, modifying and discontinuing of a patient’s
drug therapy by a pharmacist in accordance with a collaborative
practice agreement
• Medication Therapy Management
– Monitoring and evaluating patient’s response to medication
– Developing a plan for resolving medication-related problems
– Educating the patient on use of medications and monitoring
devices
– Monitoring and assessing the results of the patient’s laboratory
testing
Outcomes
Outcomes
• A Randomized Trial of the Effect of Community
Pharmacist Intervention on Cholesterol Risk
Management (2002)
– Tsuyuki et. al
– Randomized, controlled trial conducted in 54 community
pharmacies
– 675 patients enrolled
– Early termination of the study because of striking evidence
of benefit in the intervention group compared with the
usual care group (p < 0.0001)
– A community-based intervention program improved the
process of cholesterol management in high-risk patients
Outcomes
• Does point-of-care testing lead to the same or
better adherence of medication? (2009)
– Gialamas et. al
– Multicenter, cluster randomized controlled trial using
non-inferiority analysis
– 4968 patients with established type 1 or type 2
diabetes, established hyperlipidemia, or requiring
anticoagulant therapy
– Point-of-care testing was non-inferior to pathology
laboratory testing in relation to the proportion of
questionnaire responses indicating medication
adherence
Outcomes
• Evaluation of a pharmacist-managed lipid
clinic that uses point-of-care lipid testing
(2010)
– Gerrald, Dixon, Barnette, Williams
– Retrospective, observational analysis
– 81 patients met study inclusion criteria
– An outpatient hospital-based, pharmacistmanaged lipid clinic improved LDL-C goal
attainment
Outcomes
• Warfarin Management Using Point-of-Care
Testing in a University-Based Internal
Medicine Residency Clinic (2012)
– Smith, Harrison, Ripley, Grace, Bronze, Jackson
– Anticoagulation-focused quality improvement
initiative
– 167 INR values obtained
– The results showed significant improvement in the
percentage of patients who were in the the
therapeutic range with the use of POCT
Case
ML is a 28 year old female who wants to use
your point-of-care testing services. She cannot
go to a doctor because she does not have any
insurance.
Which point-of-care tests would you
recommend to use on ML?
FYI
CLIA PROGRAM
Division of Licensing & Regulatory Services
41 Anthony Avenue, Station #11
Augusta, ME 04333-0011
(207) 287-9339
Fax: (207) 287-9304
Contact: Dale Payne
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf
Resources
• http://wwwn.cdc.gov/clia/Resources/WaivedT
ests/pdf/WavedTestingBookletWeb.pdf
• http://wwwn.cdc.gov/clia/Resources/WaivedT
ests/pdf/ReadySetTestBooklet.pdf
References
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Galt KA, Demers RF, Herrier RN. ASHP Statement on the Pharmacist’s Role in Primary Care. AJHP
1999; 56: 1665-7.
Subramaniam V, et al. ASHP Statement on the Role of Health-System Pharmacists in Public Health.
AJHP 2008; 65: 462-7.
Giberson S, Yoder S, Lee MP. Improving Patient and Helath System Outcomes through Advanced
Pharmacy Practice. A Report to the US Surgeon General. Office of the Chief Pharmacist. US Public
Health Service. Dec 2011.
Rosenthal WM. Establishing a Pharmacy-Based Laboratory Service. J AM Pharm Assoc 2000; 40(2).
Accessed August 19, 2013.
Gutierres SL, Welty TE. Point-of-care testing: an introduction. Ann Pharmacother 2004; 38(1): 11925.
Rodis JL, Thomas RA. Stepwise Approach to Developing Point-of-Care Testing Services in the
Community/Ambulatory Pharmacy Setting. J Am Pharm Assoc 2006; 46(5): 594-604.
How to Obtain a CLIA Certificate. CMS/CDC 2003. Accessed August 5, 2013.
Tsuyuki R, et al. A Randomized Trial of the Effect of Community Pharmacist Intervention on
Cholesterol Risk Management: The Study of Cardiovascular Risk Intervention by Pharmacists
(SCRIP). Arch Intern Med 2002; 162:1149-55.
Gerrald KR, Dixon DL, Barnette DJ, Williams VG. Evaluation of a pharmacist-managed lipid clinic that
uses point-of-care lipid testing. J Clin Lipidology 2010; 4(2):120-125.
Smith M, Harrison D, Ripley T, Grace S, Bronze M, Jackson R. Warfarin Management Using Point-ofCare Testing in a University-Based Internal Medicine Resident Clini. AJMS 2012; 344(4):289-293.
Gialamas A, et al. Does point-of-care testing lead to the same or better adherence to medication? A
randomised controlled trial: the PoCT in General Practice Trial. MJA 2009; 191(9): 487-491.
Question 1
How do you obtain a CLIA Certificate of Wavier?
A.
Complete the CLIA application (Form CMS-116) and send it to the
Maine Board of Pharmacy. There is a one-time minimal
registration fee
B. Pay a one-time minimal registration fee that covers the cost of the
CLIA enrollment in addition to a compliance fee that covers the
cost of initial inspection by the CMS local state agency
C. Complete the CLIA application (Form CMS-116) and send it to the
CMS local state agency. There is a biennial certificate fee
D. Pay a minimal registration fee that covers the cost of the CLIA
enrollment. Once CMS receives verification from the accreditation
organization that you have selected, you will pay a certificate fee
and validation fee to CMS.
Question 1
How do you obtain a CLIA Certificate of Wavier?
A.
Complete the CLIA application (Form CMS-116) and send it to the
Maine Board of Pharmacy. There is a one-time minimal
registration fee
B. Pay a one-time minimal registration fee that covers the cost of the
CLIA enrollment in addition to a compliance fee that covers the
cost of initial inspection by the CMS local state agency
C. Complete the CLIA application (Form CMS-116) and send it to
the CMS local state agency. There is a biennial certificate fee
D. Pay a minimal registration fee that covers the cost of the CLIA
enrollment. Once CMS receives verification from the accreditation
organization that you have selected, you will pay a certificate fee
and validation fee to CMS.
Question 2
In terms of point-of-care testing, what are pharmacists
allowed to do?
A. Pharmacists are allowed to perform point-of-care tests on
patients in all patient settings
B. Pharmacists are only allowed to assist physicians
performing tests on patients within an institutional setting
C. Pharmacists are only allowed to supervise patients
performing tests on themselves in an outpatient setting
D. Pharmacists are allowed to perform tests, as well as
diagnose the problem in all patient settings.
Question 2
In terms of point-of-care testing, what are pharmacists
allowed to do?
A. Pharmacists are allowed to perform point-of-care tests
on patients in all patient settings
B. Pharmacists are only allowed to assist physicians
performing tests on patients within an institutional setting
C. Pharmacists are only allowed to supervise patients
performing tests on themselves in an outpatient setting
D. Pharmacists are allowed to perform tests, as well as
diagnose the problem in all patient settings.
Question 3
In terms of health care screening events, which statement
is correct?
A. Screening events allow pharmacists the ability to
diagnose a problem in a timely manner
B. Screening events must match the specific audience at
the specific time of day at that specific location in
accordance with an obtained CLIA waiver
C. Screening events allow pharmacists to engage in
profitable business venture
D. Screening events must engage as many patients as
possible, regardless of accuracy.
Question 3
In terms of health care screening events, which statement
is correct?
A. Screening events allow pharmacists the ability to
diagnose a problem in a timely manner
B. Screening events must match the specific audience
at the specific time of day at that specific location in
accordance with an obtained CLIA waiver
C. Screening events allow pharmacists to engage in
profitable business venture
D. Screening events must engage as many patients as
possible, regardless of accuracy.
Question 4
Which of the following CLIA waived tests could
you see at a pharmacy?
A.
B.
C.
D.
Blood glucose readings
Pregnancy urinalysis
Liver enzyme activity
All of the above
Question 4
Which of the following CLIA waived tests could
you see at a pharmacy?
A.
B.
C.
D.
Blood glucose readings
Pregnancy urinalysis
Liver enzyme activity
All of the above
Questions?