At the end of this presentation, the learner should be able to:

1. Getting to the Point: Finger-Stick Testing in Pharmacy PracticeSeptember 7, 2013Peter Kim, PharmDPGY1 Community Pharmacy ResidentUniversity of New EnglandMartin’s Point Health Care

2. 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

3. 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)

4. Point-of-care Testing

5. 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

6. 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)

7. Opportunities • Outpatient • Community pharmacy • Ambulatory care • Inpatient • Emergency medicine • Critical care

8. Common Tests Outpatient Inpatient Cardiac Markers INR CBC HLA Typing Hepatitis C • Blood glucose • Cholesterol • AST/ALT • Pregnancy • HIV • STDs • Drug

9. Legal and Regulatory Requirements

10. Legal and Regulatory Requirements • Basic OSHA and CLIA-waive standards • These regulations differ from those governing other typical pharmacy activities

11. 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

12. 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

13. OSHA regulations • Performing laboratory tests • Consistent use of personal protective equipment • Safe procedures

14. 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

15. 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

16. Blood Glucose • Bayer A1CNow • Bayer Contour Blood Glucose System Images taken from www.cliawaived.com

17. Cholesterol • CardioChek Analyzer • Cholestech LDX Lipid Profile Images taken from www.cliawaived.com

18. Pregnancy Tests • Pregnancy Urine Cassette Test • ClinitesthCG Pregnancy Test Images taken from www.cliawaived.com

19. HIV/HCV • Oraquick ADV HIV 1-2 Rapid Test Kit • Oraquick HCV Rapid Antibody Test Images taken from www.cliawaived.com

20. 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”

21. 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

22. Establishing a CLIA waived site

23. Location • Clean, stable, level workspace • Patient confidentiality • Temperature/humidity • Utilities • Safe waste disposal http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf

24. Personnel • Required personnel • Able to demonstrate competency • Employee training http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf

25. 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

26. Other requirements • Recordkeeping • Exposure control plan • In Maine, you need a Health Screening Permit

27. What happens in emergencies? • Be prepared! • Supplies you should have on hand • Make a kit • Smelling salts • Bandages • Ice pack

28. Point-of-care Program Incorporation

29. 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

30. Outcomes

31. 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

32. 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

33. 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

34. 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

35. 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?

36. 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

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

38. 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. • GibersonS, 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 Pharmacother2004; 38(1): 119-25. • RodisJL, 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 ClinLipidology 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.

39. Question 1 How do you obtain a CLIA Certificate of Wavier? • Complete the CLIA application (Form CMS-116) and send it to the Maine Board of Pharmacy. There is a one-time minimal registration fee • 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 • Complete the CLIA application (Form CMS-116) and send it to the CMS local state agency. There is a biennial certificate fee • 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.

40. Question 1 How do you obtain a CLIA Certificate of Wavier? • Complete the CLIA application (Form CMS-116) and send it to the Maine Board of Pharmacy. There is a one-time minimal registration fee • 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 • Complete the CLIA application (Form CMS-116) and send it to the CMS local state agency. There is a biennial certificate fee • 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.

41. Question 2 In terms of point-of-care testing, what are pharmacists allowed to do? • Pharmacists are allowed to perform point-of-care tests on patients in all patient settings • Pharmacists are only allowed to assist physicians performing tests on patients within an institutional setting • Pharmacists are only allowed to supervise patients performing tests on themselves in an outpatient setting • Pharmacists are allowed to perform tests, as well as diagnose the problem in all patient settings.

42. Question 2 In terms of point-of-care testing, what are pharmacists allowed to do? • Pharmacists are allowed to perform point-of-care tests on patients in all patient settings • Pharmacists are only allowed to assist physicians performing tests on patients within an institutional setting • Pharmacists are only allowed to supervise patients performing tests on themselves in an outpatient setting • Pharmacists are allowed to perform tests, as well as diagnose the problem in all patient settings.

43. Question 3 In terms of health care screening events, which statement is correct? • Screening events allow pharmacists the ability to diagnose a problem in a timely manner • Screening events must match the specific audience at the specific time of day at that specific location in accordance with an obtained CLIA waiver • Screening events allow pharmacists to engage in profitable business venture • Screening events must engage as many patients as possible, regardless of accuracy.

44. Question 3 In terms of health care screening events, which statement is correct? • Screening events allow pharmacists the ability to diagnose a problem in a timely manner • Screening events must match the specific audience at the specific time of day at that specific location in accordance with an obtained CLIA waiver • Screening events allow pharmacists to engage in profitable business venture • Screening events must engage as many patients as possible, regardless of accuracy.

45. Question 4 Which of the following CLIA waived tests could you see at a pharmacy? • Blood glucose readings • Pregnancy urinalysis • Liver enzyme activity • All of the above

46. Question 4 Which of the following CLIA waived tests could you see at a pharmacy? • Blood glucose readings • Pregnancy urinalysis • Liver enzyme activity • All of the above

47. Questions?