Point of Care Testing: An Opportunity to Provide Patient Centered and Collaborative Care John T. Holmes, PharmD, BCPS Idaho State University Pharmacist Objectives Examine the risks and benefits of implementing a community pharmacy based point of care testing (POCT) program from the patient, provider and payer perspectives. Utilize previously implemented community pharmacy based POCT programs to gain institutional support for dissemination of a POCT program in your practice. Design and implement an evidence based POCT program in your practice setting. 1
Technician Objectives Differentiate point of care testing from other forms of laboratory testing. Utilize previously implemented community pharmacy based POCT programs to gain institutional support for dissemination of a POCT program in your practice. Design and implement an evidence based POCT program in your practice setting. What is Point of Care Testing (POCT)? Laboratory testing that takes place at or near the site where the patient is located Common traits: Minimally invasive Quick to perform Immediate results Screening, diagnostic, and monitoring Gutierres SL, Welty WE. Ann Pharmacother. 2004 Jan;38(1):119 25. Goble JA, Rocafort PT. J Pharm Pract. 2015 Jun 19. Terminology Clinical Laboratory Improvement Amendments (CLIA) waived tests Over 120 CLIA waived tests minimal level of complexity and low risk of erroneous results Waiver for testing in a nonlaboratory setting http://www.accessdata.fda.gov/scripts/cdrh/cfdoc s/cfclia/analyteswaived.cfm 2
Terminology Rapid Diagnostic Tests A subset of POCT Diagnostic test that is done easy and quick to perform Infectious Diseases Akinwale TP, et al. Currents in Pharmacy Teaching and Learning 2015; 7:131-136. Common Pharmacy Based POCTs Hemoglobin A1c Blood Glucose Cholesterol Serum chemistries Group A Streptococcus (RDT) Influenza (RDT) Helicobacter pylori (RDT) Thyroid Stimulating Hormone Do you currently have POCT available at your practice site? Yes No 3
How often do you perform POCT? Daily Weekly Monthly A couple times a year Never I would be comfortable discussing tests or test results with patients or prescribers. Strongly Agree Agree Neutral Disagree Strongly disagree Pharmacists and Public Health Screening 7 million people with undiagnosed diabetes 240,000 people with undiagnosed HIV 800,000 people with undiagnosed Hepatitis C Diagnostic Access to care, costs, early diagnosis/treatment Chronic Disease Monitoring and Management Inappropriate drug therapy Achievement of clinical outcomes 4
Access to Pharmacy Care Approximately 260,000 pharmacists in the US Between 59,000 and 67,000 community pharmacies in the US 13 billion visits to a pharmacy per year 275 million patient visits to a pharmacy each week 4,000 patient visits a week per pharmacy 92% of people live within 1.6 miles of a pharmacy Burley E, Klepser S, Klepser M. Mich Pharm. 2014;52(2):8 11. Each visit to a pharmacy represents a possible encounter!! Pharmacy Based POCT In March 2016, 9110 pharmacies held a CLIAwaiver Approximately 14% of all community pharmacies Majority of waivers held by chains and supermarkets 5 th leading CLIA laboratory site 10.7% increase in non Walgreens pharmacies holding a CLIA waiver between 5/15 and 3/16 Klepser ME, et al. Res Social Adm Pharm. 2016 Jul-Aug;12(4):614-21 Adams AJ, et al. Res Social Adm Pharm. 2016 Jul-Aug;12(4):666-7. 5
Historical Barriers to POCT Pharmacists lack of familiarity with POCT programs processes Pharmacists lack of physical assessment and specimen collection skills Feasibility incorporating into workflow Fragmentation of care and acceptability Administrative burden Limited financial incentives Burley E, et al. Michigan Pharmacist. 2014; 52(2):8-11. Gilbreath M. https://www.pharmacist.com/sites/default/files/files/poct%20policy%20background%20paper%20-%20final.pdf For those with POCT available, what barriers to performing POCT have you encountered?? HIV Screening Example Objective: Test feasibility of offering POC HIV testing in community pharmacies and retail clinics Setting: 21 community pharmacies and retail clinics Intervention Conceptual model for counseling and testing Training materials Relationship with health department (stakeholder) Point of care HIV testing Referral for confirmatory and HIV care if needed Marketing Weidle PJ, et al. J Am Pharm Assoc. 2014 Sep-Oct;54(5):486-92. 6
HIV Screening Example Results: 1540 test performed between 2011 and 2013 Time 4 minutes pretest counseling, consent and collection 23 minutes waiting for result 3 minutes for posttest counseling 17/21 sites planned to continue HIV testing Weidle PJ, et al. J Am Pharm Assoc. 2014 Sep-Oct;54(5):486-92. Influenza RDT Example Objective: Examine effectiveness of physicianpharmacists collaboration to treat influenza like illness Setting: 55 pharmacies in Michigan, Minnesota, and Nebraska Intervention: Brief physical exam and rapid influenza diagnostic test Referred or treated per collaborative practice agreement (CPA) Patient f/u in 24 48 hours Klepser ME, et al. J Am Pharm Assoc (2003). 2016 Jan;56(1):14-21 Influenza Example Results: 121 patients screened 45 (37%) excluded and referred to PCP or urgent care 75 (62%) eligible for participation 8 (11%) tested positive and treated per CPA Approximately 35% of patients tested had no PCP 38.7% of patients tested outside of normal business hours Klepser ME, et al. J Am Pharm Assoc (2003). 2016 Jan;56(1):14-21 7
STEP WISE APPROACH TO POCT DEVELOPMENT AND IMPLEMENTATION Rodis JL, Thomas RA. J Am Pharm Assoc. 2006;46(5):594 604. Gubbins PO, et al. J Am Pharm Assoc. 2014;54(2):163 71. Needs Assessment Evaluation Research and Organizing Implementation Materials Development Needs Assessment SWOT Analysis Strengths (internal) Location, students, pharmacist desire Weaknesses (internal) Coverage, no CLIA certificate, training Opportunities (external) Community demographics, collaborative providers Threats (external) Cost, patient acceptance 8
Needs Assessment Who are the patients that visit my pharmacy? Prescription record reports Age, gender, zip codes, medications as disease surrogates, etc. Patient Survey Focus Groups Patients, staff, medical neighborhood, etc. Stakeholder Engagement Health Departments Community Advocacy Groups Medical Providers Pharmacy Staff Patients Other Pharmacies? Research and Organize Go look at other sites conducting POCT Ask LOTS of questions!!!! Partner with other entities University faculty and students Other groups already conducting screenings Begin to work out logistics Students Residents 9
Research and Organize How will this POCT service fit into my current environment? Practice site restructuring Assessment of current and future state workflow Consider staffing, time, space, etc. Other wellness and quality improvement programs Example: Screening for ADEs Workflow Diagram Klepser ME, Adams AJ, Klepser DG. Health Secur. 2015 May-Jun;13(3):166-73. Research and Organize Regulations State Regulations State Board of Pharmacy Idaho Bureau of Laboratories Disease reporting (Infectious Diseases) Federal Regulations Occupational Safety and Health Administration (OSHA) Bloodborne pathogens PPE HIPAA 10
Do State Boards of Pharmacy allow pharmacists to conduct POCT? Yes No Idaho Board of Pharmacy Definition of Pharmaceutical Care Services (updated 2016) ordering and interpreting laboratory tests Idaho Board of Pharmacy. How to Obtain a CLIA Waiver and Begin Testing. 2016. https://bop.idaho.gov/continuing_education/2016-08-17_ce-howtoobtainacliawaiverandbegintesting.pdf Washington Board of Pharmacy Monitoring of drug therapy by pharmacists Ordering and evaluating the results of laboratory tests relating to drug therapy including, but not limited to, blood chemistries and cell counts, drug levels in blood, urine, tissue or other body fluids, and culture and sensitivity tests when performed in accordance with policies and procedures or protocols applicable to the practice setting which include appropriate mechanisms for reporting to the prescriber monitoring activities and results Washington State Pharmacy Laws and Rules. Monitoring of drug therapy by pharmacists. 246-863-110. Available at http://www.doh.wa.gov/portals/1/documents/pubs/690214.pdf 11
Montana Board of Pharmacy Definition of Clinical Practice Experience ordering and monitoring medications, and/or laboratory tests in accordance with established standards of practice. Montana Board of Pharmacy. 24.174.525. Available at http://www.mtrules.org/bookview/printcontent.asp?sl=chpt&id=348&bd=5%2f1 2%2F2017 Idaho CLIA Certificate of Waiver State of Idaho Clinical Laboratory Registration form http://www.keysurvey.com/votingmodule/votin G3/f/993225/d72c/?msig=f88532fc59887 Federal CMS Form 116 laboratory registration form https://www.cms.gov/medicare/cms Forms/CMS Forms/Downloads/CMS116.pdf Washington CLIA Certificate of Waiver Certificate of Waiver Medical Test Site http://www.doh.wa.gov/portals/1/documents/pu bs/505038.pdf Do NOT need to complete CMS Form 116 12
Montana CLIA Certificate of Waiver Federal CMS Form 116 laboratory registration form Send to the Montana CLIA Program via: Fax 406 444 3456 Email mtssad@mt.gov Mail No other forms CLIA Certificate of Waiver General information Type of certificate (CoW) Setting (pharmacy) Hours of testing Number of sites Approx. number of tests per year Name, address and signature of laboratory director CLIA Certificate of Waiver Both forms must be completed for each pharmacy Cost State registration is no charge CMS registration (Form 116) is $150 Time Expect 1 3 weeks for processing Renew every 2 years Idaho Board of Pharmacy. How to Obtain a CLIA Waiver and Begin Testing. 2016. 13
Training What are the basic qualifications each pharmacist should have to be able to provide care within this new POCT service? National guidelines (e.g. AHRQ App) Visit another pharmacy currently doing POCT Conferences Industry partnerships POCT Certificate Program Community Pharmacy Based Point of Care Testing Certificate Supported by the National Association of Chain Drug Stores 12 hours of home study; 8 hours of live training Also have a train the trainer program http://nacds.learnercommunity.com/point of Care Testing Certificate Entry Level Pharmacist Competencies Collect, interpret, and make recommendations based on the results of health and wellness screenings and diagnostic tests Describe the need for Clinical Laboratory Improvement Amendments (CLIA) waiver and describe documentation of testing done in the community pharmacy Accreditation Council for Pharmacy Education. Guidance for the accreditation standards and key elements for the professional program in pharmacy leading to the doctor of pharmacy degree. Available at: https://www.acpe-accredit.org/pdf/guidanceforstandards2016final.pdf. 14
Select a Device Device specifications Portability Testing procedure Should be simple, fast and accurate Cost Device, supplies, warranty Lease versus buy versus share Reimbursement Direct payment for the service Collaborating directly with third party payers and other stakeholders Reimbursement for the test Third party payers may pay for this Reimbursement for the pharmacists time Burley E, et al. Mich Pharm. 2014;52(2):8 11. Darin KM, et al. J Am Pharm Assoc. 2015;55(1):81 88. Develop Materials Standard Operating Procedures Care of the machine Testing procedure Quality assurance testing Documentation Patient and provider follow up and communication Checklists 15
Goals of the Program Develop short and long term goals Specific, measurable, achievable, realistic, timebound By November 30, 2017 5% of patients born between 1945 and 1965 with a prescription fill in the past 6 months will have had a hepatitis C screening test at our pharmacy. Develop a timeline Consider budget, staffing, competing priorities, etc. Task or Action Person Responsible Timeline Date Due Completed SWOT Analysis Brett 6/1/2017 Yes CLIA Certificate of Waiver Brett 7/15/2017 No Pharmacy Workflow Susan 7/15/2017 Yes Redesign SOPs and Training Material Joe 8/1/2017 Yes Device Purchase Brett 8/1/2017 No Staff Training Susan 8/15/2017 No Marketing Joe 9/1/2017 No Documentation and Patient Visits Don t recreate the wheel. Ask other pharmacies doing POCT, consult potential payers, etc. Electronic versus paper Consent forms with HIPAA statement Medical history form Documentation of encounters form 16
Collaboration Consider collaborating with a local physicians office or health department on certain initiatives Collaborative practice agreements Standing orders Implementation of treatment protocols Implementation Who is my target audience? Marketing Signage, messages on receipts, mailers, bag stuffers, etc. Personal marketing (staff and customers) Community wide advertising Ask patients who receive POCT how they heard about the service and why they utilized the service Evaluate the Program Continuous Quality Improvement Process versus patient outcomes Evaluate each step of process Patient satisfaction survey, chart review Financial Feedback from stakeholders What works, what needs improved Use students!!! 17
IHI. http://www.ihi.org/resources/pages/howtoimprove/default.aspx Useful Resources Centers for Disease Control and Prevention https://wwwn.cdc.gov/clia/resources/waivedtest s/ Ready? Set? Test! To Test or Not to Test MMWR R&R Good Laboratory Practices for Waived Testing Sites Activity Think Pair Share Is there a business case for POCT in your pharmacy setting? Who are the patients at your site that may benefit from a POCT service? Who are the key stakeholders you need to engage to implement this service? How could POCT be implemented in your site? 18
Selected References Idaho Board of Pharmacy. How to Obtain a CLIA Waiver and Begin Testing. 2016. https://bop.idaho.gov/continuing_education/2016 08 17_CE HowtoObtainaCLIAWaiverandBeginTesting.pdf Gilbreath M. Point of Care Testing: Background Paper Prepared for the 2015 2016 APhA Policy Committee. Available at: https://www.pharmacist.com/sites/default/files/files/poct%20policy%20background%20paper%20 %20FINAL.pdf ACPE. Guidance for the accreditation standards and key elements for the professional program in pharmacy leading to the doctor of pharmacy degree. Available at: https://www.acpe accredit.org/pdf/guidanceforstandards2016final.pdf. Gutierres SL, Welty WE. Point of care testing: an introduction. Ann Pharmacother. 2004 Jan;38(1):119 25. Burley E, Klepser S, Klepser M. Opportunities for pharmacists to improve access to primary care through use of CLIA waived tests. Mich Pharm. 2014;52(2):8 11. 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. Gubbins PO, Klepser ME, Dering Anderson AM, et al. Point of care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy. J Am Pharm Assoc. 2014;54(2):163 71. Weidle PJ, et al. HIV testing in community pharmacies and retail clinics: a model to expand access to screening for HIV infection. J Am Pharm Assoc. 2014 Sep Oct;54(5):486 92. Adams AJ, Klepser ME, Klepser D. An update on community pharmacies as CLIA waived facilities. Res Social Adm Pharm. 2016 Jul Aug;12(4):666 7. Klepser ME, Adams AJ, Srnis P, Mazzucco M, Klepser D. U.S. community pharmacies as CLIA waived facilities: Prevalence, dispersion, and impact on patient access to testing. Res Social Adm Pharm. 2016 Jul Aug;12(4):614 21. Goble JA, Rocafort PT. Point of Care Testing: Future of Chronic Disease State Management? J Pharm Pract. 2015 Jun 19. Klepser ME, Adams AJ, Klepser DG. Antimicrobial stewardship in outpatient settings: leveraging innovative physician pharmacist collaborations to reduce antibiotic resistance. Health Secur. 2015 May Jun;13(3):166 73. Akinwale TP, Adams AJ, Dering Anderson AM, & Klepser ME. Pharmacy based point of care testing for infectious diseases: Considerations for the pharmacy curriculum. Currents in Pharmacy Teaching and Learning. 2015; 7:131 136. Darin KM, Klepser ME, Klepser DE, et al. Pharmacist provided rapid HIV testing in two community pharmacies. J Am Pharm Assoc. 2015;55(1):81 88. Klepser ME, et al. Effectiveness of a pharmacist physician collaborative program to manage influenza like illness. J Am Pharm Assoc. 2016 Jan;56(1):14 21 19