Getting to the Point: Finger-Stick Testing in Pharmacy Practice

September 7, 2013

Peter Kim, PharmDPGY1 Community Pharmacy Resident

University of New EnglandMartin’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

Outpatient• Blood glucose• Cholesterol• AST/ALT• Pregnancy• HIV• STDs• Drug

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-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_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-of-care

testing conducted in each laboratory

Establishing a CLIA waived site

Location

• Clean, stable, level workspace

• Patient confidentiality

• Temperature/humidity

• Utilities

• Safe waste disposalhttp://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 reagentshttp://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, pharmacist-

managed 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 PROGRAMDivision of Licensing & Regulatory Services41 Anthony Avenue, Station #11Augusta, ME 04333-0011(207) 287-9339Fax: (207) 287-9304Contact: Dale Payne

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf

Resources

• http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf

• http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/ReadySetTestBooklet.pdf

References• 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): 119-25.• 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-of-Care 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 1How 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 1How 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. Blood glucose readingsB. Pregnancy urinalysisC. Liver enzyme activityD. All of the above

Question 4

Which of the following CLIA waived tests could you see at a pharmacy?

A. Blood glucose readingsB. Pregnancy urinalysisC. Liver enzyme activityD. All of the above

Questions?