Community HIV Testing Policies & Procedures Iowa Pharmacy Association

Version 1.0

TABLE OF CONTENTS

1. Mission Statement, Vision, Goals 2. Overview and Timeline

a. Evaluation/Outcomes 3. Practice Considerations

a. CLIA Waivers b. Patient Education

4. IDPH Testing Requirements a. Testing Requirements

b. Informed Consent c. Reactive Test: Client Level Data Collection d. Active Referral to Confirmatory Testing e. Anonymous Testing f. Policy for Mailing Confidential Patient Information g. Record Storage and Retention Requirements h. Ordering INSTI Rapid Test Kits and Forms

5. Relevant Law a. Reporting Results b. Related Laws

6. Quality Assurance Measures a. Minimum Quality Expectations b. Quality Control Procedures

7. HIV Testing Process a. Preparing Testing Area, Materials, and Equipment b. Preparing to Conduct the HIV Test c. Performing the HIV Test d. Counseling on Results e. Referrals for Confirmatory Testing

8. Appendix and Resources

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APPENDIX Attachment A Letter of Commitment Attachment B Rapid HIV Test Case Report Form (Sample) Attachment C HIV Information and Testing Agreement Attachment D Pharmacist Referral to Confirmatory Testing Flowchart Attachment E INSTI Rapid HIV Testing Quality Issue Report Attachment F INSTI Rapid HIV Test Usage Log Attachment G Pharmacist Testing Work Flow Attachment H Collaborative Practice Agreement Attachment I Coordination of Confirmatory Testing Agreement Form (CCTA) Attachment J Referral for Confirmatory Testing Card (Sample) Attachment K Minor’s Consent Form for HIV Testing Attachment L IDPH Funded Test Sites Attachment M HIV Risk Reduction Patient Referral Card (Sample) Attachment N Cohort 1 Test Sites

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MISSION____________________________________________________________________________ Developing a community pharmacy-based HIV screening and referral program that fully utilizes the knowledge and expertise of pharmacists to improve patients’ health outcomes and provide a safe and cost-effective screening service. VISION_____________________________________________________________________________ To create a collaboration with patients, health care providers, and the Iowa Department of Public Health to share responsibility for improving positive patient outcomes by improving access to HIV screening in coverage gap areas in the state of Iowa by expanding and integrating clinical pharmacy functions currently underutilized in the health care system GOALS_____________________________________________________________________________ The community pharmacy-based HIV testing program strives to meet the following goals:

1) Enhance patient safety a. Increase patient access to HIV testing sites by expanding areas of coverage in

community pharmacies in selected areas throughout the state. b. Provide counseling and referrals for confirmatory testing to ensure patients begin and

continue proper treatment. c. Decrease risk of co-morbidity and reduce stigma associated with HIV.

2) Gain recognition by patients, providers, and payers of healthcare as a valuable service. a. Become integral to physicians, patients, families and the entire healthcare team by

serving and functioning as an accessible site for patients to receive important health screenings and become integrated into the health system.

b. Educate healthcare payers 3) Improve patient health outcomes

a. Measurable, reproducible outcomes b. Provide data that can be evaluated to show progress to pharmacists, physicians,

patients and overall healthcare system 4) Reproducible 5) Professionally rewarding

a. Align with current pharmacy education experiences 6) Financially sustainable

a. Decrease overall patient healthcare costs

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Community HIV Testing

Project Overview & Timeline Iowa Pharmacy Association

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Project Overview & Timeline

SUMMER 2018________________________________________________________

I. Community HIV Testing Contact List Verified a. Update Contact List b. Send out feasibility survey to selected sites

II. Establish project expectations with pharmacies and others

a. Purpose/Mission III. Letter of Understanding

a. Pharmacy commitment to the project ideas and implementation IV. Finalize detailed information- Policy Handbook Created

a. Define mission and policies in bullet points b. Toolkit binder tabs for each of the original task force workgroups

V. Provide Structure for pilot implementation a. Determine workflow for pilot sites b. Job descriptions for pharmacist and technicians c. Establish minimum requirements needed for pilot sites

VI. Establish Policies & Procedures a. POC Screening tool b. CLIA waivers

VII. Create an economic model for the Community-based Pharmacy HIV Testing Program a. Determine value of services

VIII. Finalize verbal commitment from pharmacy pilot sites a. Inform pharmacies about the program b. Collect written statement commitment

IX. Send invitation and letter of commitment to focus counties. X. Establish Patient and Public Education

a. Create Pamphlets/Summaries b. Create marketing campaign for participating sites with the help of IDPH

FALL 2018___________________________________________________________

I. Communicate to physician community, nurses, ARNPs and other healthcare providers about new pilot project

II. Pharmacist education and trainings III. Encourage committed sites to begin preparing for program roll-out

a. Pharmacist education and training b. Educate patients on transition, make necessary pharmacy modification

IV. Collect preliminary data if necessary

JANUARY 2019 AND ONWARD__________________________________

I. Implement Pilot Project

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ONGOING EFFORTS__________________________________________________

I. Update IPA membership quarterly II. Inform Legislators of Community-based Pharmacy HIV Testing Program III. Inform Pharmacists Mutual about upcoming pilot project IV. Communicate with healthcare providers about the new implementation of the pilot project

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Evaluation/Outcomes

Objective: Provide technical assistance and trainings to support the implementation of HIV/HCV screening within Iowa community-based pharmacies. Iowa Pharmacy Association (IPA) along with the Iowa Department of Public Health (IDPH) will develop a training curriculum for Iowa community-based participating pharmacies. By monitoring CDC and other relevant websites and publications, this training will be current and up-to-date. Participating pharmacists will be required to complete this in-person training to learn how to perform the test with the INSTI HIV-1 Antibody test kit. This training will provide technical expertise for each pharmacist to correctly and accurately perform a screening test. IPA will also provide education and information to participating community-based pharmacies and other Iowa-based pharmacies on webinars and trainings relevant to the provision of preventive services, including special and target populations.

Throughout the project, IPA’s Lead Project Manager will be available to field questions and provide technical assistance throughout the duration of the program. Each pharmacist will have resources, which are found at the end of this manual, to help with ordering kits and forms, performing control tests, performing the screening test, what to do in the event of faulty tests, a decision tree detailing the process of conducting a screening test, referral sites for confirmatory testing in reactive tests, and a contact list to direct questions and concerns.

Objective: Monitor preventive services guidelines and develop the framework for a best practices manual for community-based pharmacies. Participating pharmacies will help Identify barriers and successes to providing preventive services at pharmacies. IPA will compile a best practices screening manual and revise throughout the multiyear project as needed. This manual serves as the resource for participating pharmacies of the project. The Lead Project Manager and IDPH will check in periodically with all sites in ensuring that data collection is being done properly and in a timely manner. This will also help IDPH and IPA address any issues that may arise throughout the pilot program. Keeping up to date with the CDC guidelines will help participating pharmacies stay informed. This manual will be updated and distributed as needed when a change should be made.

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Practice Considerations Iowa Pharmacy Association

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CLIA Waivers

How to Apply for a CLIA Certificate APPLICATION FOR A CLIA CERTIFICATE: FORM CMS-116

The Centers for Medicare & Medicaid Services (CMS) has made available the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Application for Certification Form, CMS-116. This form should be completed and mailed to the address of the local State Agency for the state in which your laboratory or pharmacy resides. The CMS-116 form and its instructions are found as a download at the website www.cms.hhs.gov/clia inside the CMS section and contain the following information: • The CLIA application form, CMS-116; • Instructions for completing the CMS-116; • Guidelines for counting tests for CLIA; • Certificate fees for laboratories established under CLIA; and • Tests commonly performed and their corresponding laboratory specialties/subspecialties. CLIA requires all entities that perform even one test, including waived test on ... "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program. The CLIA application collects information about a laboratory's operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed. NOTE: If you have any questions regarding the completion of the CMS-116 form, contact the appropriate State. You should also contact this State Agency for additional forms that may be necessary to complete the registration process or for any additional questions. Be sure to contact your State Agency to ensure that you have all the necessary information that is required for the application.

Iowa CLIA Compliance Manager: Kristi Rotzoll 319-335-4398, Kristine-rotzoll@uiowa.edu

Individuals who attended foreign schools must have an evaluation of their credentials determining equivalency of their education to education obtained in the United States. Failure to submit this information will delay the processing of your application.

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Patient Education Teaching the public and your patients about your new initiatives will be imperative to its success. First and foremost, it is important that the patient knows what their pharmacist does. IPA will create patient facing marketing materials. Furthermore, IPA and IDPH have customizable materials available for print as well as social media. For more information, contact IPA’s Lead Project Manager.

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Iowa Department of Public

Health Testing Requirements Iowa Pharmacy Association

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Testing Requirements

Pharmacy locations offering testing will receive INSTI RAPID HIV Test Usage Log which will be used to track only the number of test kits used.

Informed Consent

In order for a pharmacist to administer the test to a client, the client must first give consent. To give informed consent, the client must understand the purpose of the test, as well as the meaning of a non-reactive or a reactive result. When that is completed, the pharmacist should give the client a few minutes to review the Manufacturers Subject Information Pamphlet and answer any questions. The pharmacist should then discuss the following things with the client:

• The difference between confidential and anonymous testing

• The difference between rapid and conventional testing

• The difference between a screening and confirmatory test

• The procedure for a negative result and a reactive result The client should be asked if they have any questions or concerns before continuing. If not, the client should be asked about support systems in place if the test is reactive. Once the client has been adequately informed about the testing process, they can sign the consent form.

Reactive Test & Client-Level Data Collection

Only tests that are a reactive positive require client-level data collection. In order for an administered test to satisfy minimum contractual reporting requirements, it is necessary to collect client information using the Rapid HIV Screening Case Report Form (Attachment B). The following required information:

• Year of birth

• Ethnicity

• Race

• Current Gender ID

• Assigned Sex at Birth

• Previous 900 Test?

• If so, what were the results?

If any of the above information is missing, the test cannot count toward IDPH requirements, and the HIV testing location will be asked by IDPH to correct the test forms. If the client does not identify with

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any of the given classes of race or ethnicity, the testing pharmacist should select “Declined” as their response. If the client receives a preliminary reactive test result, the field at the bottom of the Rapid HIV Testing Case Report Form must also be completed:

• If positive result, referral?

• Mode of Referral

• If Declined Referral, Why? Once the client has left, it is important to ensure the completion of the Rapid HIV Testing Case Report Form, the HIV Test Usage Log, and any other internal paperwork. Prior to returning to the pharmacy, pharmacists should review the test form, verifying the accuracy of information recorded during the testing session and writing any useful additional information in the notes field at the bottom of the Rapid HIV Testing Case Report Form. The forms shall be completed accurately, completely and legibly, and submitted to IPA’s Lead Project Manager within 3 days.

Active Referral to Confirmatory Testing

If a client receives a reactive result, the testing pharmacist must provide the client with an active referral to confirmatory testing. The pharmacist may choose to perform this active referral using a collaborative practice agreement with a local provider or the pharmacist may refer the patient to an Iowa Department of Public Health funded test site.

Anonymous Testing

Non-clinical testing supported by IDPH is confidential, and not anonymous. This means that name and demographic information must be collected.

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Policy for Submitting Rapid HIV Screening Case Report Form

A copy of the Rapid HIV Screening Case Report should be scanned and emailed directly to IPA’s Lead Project Manager within 3 days of the positive reactive test. The original copy of the Report should be kept at the pharmacy. IPA will then report all case reports to IDPH on a monthly basis.

Record Storage and Retention Requirements

HIV Screening Case Report documentation must be kept under the three-lock rule—there must be three locks (example: locked Pharmacy door, locked office, locked cabinet) between the entrance of a pharmacy location and where patient identifying information is stored. Pharmacies must retain HIV Information and Testing Agreement, Rapid HIV Screening Case Report Form and Collaborative Practice Agreement / Coordination of Confirmatory Testing Agreement and Minor Consent form if applicably, for a period of five years, after which the pharmacy locations may destroy testing records. Custodians of records must ensure that information in confidential or privacy-protected records is protected from unauthorized disclosure through the ultimate destruction of the information. Ultimate destruction is accomplished through cross-shredding, pulping, burning, and overwriting or physically destroying media. Deletion of confidential or privacy-protected information in computer files or other electronic storage media is not acceptable. If a pharmacy ceases operation prior to the end of the five-year period, or if IDPH deems that confidentiality is not being maintained, all Reporting Forms and other testing information containing patient identifiers must be returned to IDPH for storage.

Ordering INSTI Rapid Test Kits and Forms

INSTI test kits and Rapid HIV Screening Reporting Forms can be ordered by emailing the IPA’s Lead Project Manager, Kellie Staiert, kstaiert@iarx.org

• The Lead Project Manager will order Test Kits and Test Kit Controls by contacting IDPH. Include in the email the following information:

o Email subject line: HIV Test Kit Order o Pharmacy Address o Date o Site representative/Contact Name o Pharmacy phone number/Contact Phone Number o Quantity of Item Needed o Indicate if Urgent (Yes/No) o Comments or notes regarding request

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• Test Kits and Test Kit Controls will be mailed directly to the pharmacy. Please allow a 7-10 day turnaround.

• Under pads, clipboards, and sharps containers can be provided by IDPH if needed. Include your request in Test Kit Order Email

As the length of time required to ship forms may vary, it is recommended to keep at least 100 Rapid HIV Screening Case Report forms on-hand. As the length of time required to ship INSTI tests, it is recommended to keep at least a one-month supply of test kits on-hand (the exact number will vary by individual store). Should you run low or run out of tests please contact your supervisor immediately. Any questions regarding the ordering of test kits can be addressed to IPA’s Lead Project Manager.

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Relevant Law Iowa Pharmacy Association

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Reporting Results

The state of Iowa does not have a mandatory reporting law for rapid testing processes. Only for positive reactive tests is information from patients, including test results, reported to IDPH and used for epidemiological data. In the event of a positive reactive result, if necessary a DIS will be assigned to the patient and offer them assistance in notifying their sexual and/or drug use partners that may have been exposed to HIV. The DIS will also offer HIV testing to any partners identified by the client.

Related Laws

99 Acts, Ch 181, §8 2007 Acts, Ch 70, §5 2011 Acts, Ch 63, §26 https://www.legis.iowa.gov/DOCS/ACO/IC/LINC/Section.139A.3.pdf https://www.legis.iowa.gov/docs/publications/iactc/84.1/CH0063.pdf https://www.legis.iowa.gov/docs/publications/iactc/82.1/CH0070.pdf

https://www.legis.iowa.gov/docs/publications/iactc/82.1/CH0070.pdf

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Quality Assurance Measures Iowa Pharmacy Association

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Minimum Quality Expectations

i. Patients must be tested in a confidential manner, and in a location that provides privacy. ii. Testing pharmacists must complete all mandated trainings before conducting rapid HIV testing.

iii. Testing pharmacists conducting rapid HIV testing shall determine, on an individual basis, the sobriety and/or mental status of each client. A rapid HIV test shall not be performed, nor results provided, if the tester believes that the client cannot comprehend the meaning of the test or may be a danger to him or herself or others.

iv. Persons who have identified themselves as HIV-positive and who are requesting a test to prove their status for any reason, such as medical care, case management, etc., shall not be retested with a rapid HIV test. Instead, these individuals shall be referred to the local health department or an infectious disease clinic for serum testing. In some cases, HIV-positive individuals may present for testing in order to maintain their own confidentiality (i.e., large-scale testing events, a group of friends who all decide to get tested together, etc.). In these cases, a rapid test can be performed, but a confirmatory test need not be conducted. For continuity of paperwork, pharmacies shall collect sufficient data needed to confirm a client’s previous HIV diagnosis and transmit this information to IDPH.

v. Testing pharmacists may provide testing only to those patients who sign the HIV Information and Testing Agreement.

vi. Before conducting an HIV test, testing pharmacists shall inform the client that the test is a screening test, and further testing must be done to confirm a preliminary positive result. In delivering a preliminary positive HIV test to a client, pharmacists shall again remind the client that the test is a screening test and that a confirmatory test will need to be conducted by a partner agency.

vii. All testing sites must display a copy of the original CLIA certificate of waiver. viii. Pharmacists shall offer the client the INSTI HIV-1 Antibody Test Subject Information Brochure

during the testing session. ix. Pharmacists conducting testing shall read and understand the package insert. Pharmacists also

must have read the Pharmacy HIV Testing Policies, Procedures and Quality Control document (this manual).

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Quality Control Procedures

INSTI HIV-1 Antibody Test Kit External Controls When to Run Controls

• INSTI HIV-1 Positive and Negative Controls must be run under the following circumstances: o With each newly-trained INSTI operator prior to performing their first test on patient

specimens. o When opening a new INSTI test kit lot. o Whenever a new shipment of test kits is received (even if test kits are from the same lot

previously received). o If the temperature of the test kit storage area falls outside of 59-86°F. o If the temperature of the testing area falls outside of 59-86°F.

Quality Control Specimen Handling

• Test Kit Controls will be placed in the freezer immediately upon receipt of shipment.

• Test Kit Controls are to be stored at a temperature of < -4°F when not in use for up to 1 year. Remove from storage at < -4°F and allow the Controls to reach room temperature before testing with INSTI. Test Kit Controls should be left out for 15 minutes in order to come to room temperature.

• Once the controls are thawed following storage at < -4°F, they remain stable for 28 days in the refrigerator at a temperature of 35.6-46.4°F. Do not re-freeze. When control vials are opened, they will be marked with the date opened and the date to be discarded (28 days from open date). Each Control vial contains enough specimen to conduct 8 quality control tests.

• Temperature of the freezer and refrigerator will be monitored by the pharmacy staff twice daily and will be documented on the Temperature Log.

• Do not use Test Kit Controls beyond the expiration date.

Performing External Controls

• Cover the workspace area with a clean, absorbent under-pad.

• The testing pharmacist is to put on gloves prior to starting the Quality Control process.

• Remove one Positive Control vial and one Negative Control vial from storage at < -4°F and allow Controls to reach room temperature before testing with INSTI. Test Kit Controls should be left out for 15 minutes in order to come to room temperature.

• Open the INSTI HIV-1 Test Membrane Unit by tearing at the notches on the top of each side of the foil pouch. Do not touch the center well of the Membrane Unit. Do not use if the foil pouch has been previously opened or if the packaging integrity is compromised in any manner. Once the Membrane Unit has been opened, it must be used immediately.

• Place the Positive Control vial and Membrane Unit on the absorbent pad with the tab of the Membrane Unit facing the testing pharmacist.

• Remove one vial of Sample Diluent (Solution 1), Color Developer (Solution 2), and Clarifying Solution (Solution 3) and place on absorbent pad. Remove one single-use pipette and place on absorbent pad.

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• Mix the Positive Control by swirling for 5 seconds prior to use. Uncap the Positive Control vial. Take the pipette and lightly depress the top bulb. Insert the pipette tip into the clear liquid in the Positive Control vial, slowly releasing the top bulb to completely fill the pipette stem. Ensure that the liquid in the stem reaches only to the fill line, designating 50 μL. Open the Sample Diluent (Solution 1) and transfer the Positive Control sample held in the pipette to the Sample Diluent bottle by completely squeezing the pipette bulb. Recap the Sample Diluent bottle and mix by inversion for 5 seconds.

• Pour the entire contents of the Sample Diluent bottle to the center of the Membrane Unit well. o This must be done within 5 minutes of adding the Positive Control specimen to the

Sample Diluent. The mixture should be absorbed through the membrane in less than 30 seconds; however, absorption times will vary slightly.

o IMPORTANT: If at any period during the quality control procedure, the Sample Diluent, Color Developer, or Clarifying Solution stop flowing through the Membrane Unit, the procedure must be stopped and re-started with new INSTI components.

• Re-suspend the Color Developer (Solution 2) by inversion for 5 seconds. Open the Color Developer and add the entire contents to the center of the Membrane Unit well. The colored solution should flow through completely in about 20 seconds.

• Open the Clarifying Solution (Solution 3) and add the entire contents to the center of the Membrane Unit well. This will reduce the background color and facilitate reading of the test result. Immediately read the result once the solution is through the well.

o Do not read the results if more than 5 minutes have elapsed following addition of Clarifying Solution.

• The HIV-1 positive quality control test result should read Reactive. The test is Reactive if both the control spot and the test spot show blue color development. One spot may be darker than the other.

• The HIV-1 negative quality control test results should read Non-Reactive. A test is Non-reactive if only the control spot shows blue color development. No blue spot should be visible at the test spot, located below the control.

• The test is invalid if any of the following occurs: o There is no blue color on the control or the test spot o There is blue color on the test spot, but not the control spot o There is a uniform tint across the membrane o Only blue specks appear on the membrane

• If the negative or positive controls do not provide the expected results, testing staff will review the process for conducting the control with a new control kit to rule out cross contamination or operator error.

• Record the results and corrective actions on the INSTI Rapid HIV Testing Quality Issue Report (see Attachment E).

• If corrective action does not resolve the problem, testing with the control kits will cease, patients will not be tested with supplies in the affected testing kit, and the testing pharmacist will contact the IPA’s Lead Project Manager Manager via phone or email (515-270-0713, kstaiert@iarx.org) of the situation to report the problem.

• Dispose of the used Membrane Unit, Solution vials, and pipette in the biohazard waste container. All other materials may be disposed of in the trash.

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• Repeat the above procedures for the HIV-1 Negative Control using a new INSTI Membrane Unit, Sample Diluent, Color Developer, Clarifying Solution, and pipette.

• Each Control vial contains enough specimen to conduct 8 quality control tests. Upon completion of the quality control tests, the Positive and Negative Control vials must be placed in the refrigerator at a temperature of 35.6-46.

• 4°F where they remain stable for 28 days. Do not re-freeze. Once control vials are opened, they will be marked with the date opened and the date to be discarded (28 days from open date).

• The test kit controls shall give the expected reactive or non-reactive result or the test results are not valid. If test kit controls do not provide expected results after being repeated, contact IPA’s Lead Project Manager via phone or email (515-270-0713, kstaiert@iarx.org).

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HIV Testing Process Iowa Pharmacy Association

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Preparing Testing Area, Materials, and Equipment Testing Supplies Item Source

Rapid HIV Screening Case Report Form IPA

INSTI HIV-1 Antibody Test Kits bioLytical (orders must be placed 4 weeks in advance)

INSTI HIV-1 Antibody Test Kit Controls bioLytical (orders must be placed 4 weeks in advance)

Alcohol Prep Pads Pharmacy stock

Band-Aids Pharmacy stock

Disinfecting wipes Pharmacy stock

Underpads Pharmacy stock

Clipboard Pharmacy

Gauze Sponges 2” x 2” Pharmacy stock

Gloves Pharmacy stock

Hand Sanitizer Pharmacy stock

Lancets (included with test kits) bioLytical

Sample collection Pipette bioLytical

Sharps Containers Pharmacy

For the Iowa Department of Public Health project, the INSTI HIV-1 Antibody Test Kit and Controls will be ordered by emailing IPA’s Lead Project Manager at kstaiert@iarx.org

• The Lead Project Manager will order Test Kits and Test Kit Controls by contacting IDPH. Include in the email the following information:

o Email subject line: HIV Test Kit Order o Pharmacy Address o Date o Site representative/Contact Name o Pharmacy phone number/Contact Phone Number o Quantity of Item Needed o Indicate if Urgent (Yes/No) o Comments or notes regarding request

• Test Kits and Test Kit Controls will be mailed directly to the pharmacy. Please allow 7-10 day turnaround.

• Under pads, clipboards, and sharps containers can be provided by IDPH if needed. Include your request in Test Kit Order Email

• Upon arrival of the Test Kit and Test Kit Controls to the pharmacy, the pharmacist is to review the Customer Letter (package insert) to identify any procedural updates or changes. The

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Customer Letter is to be kept on file with the test kit and control package insert in the CLIA Waived Health Testing Binder.

• The test kit Customer Letter and control package inserts should be discarded when a new test kit or control solution is delivered to the pharmacy. The pharmacy is to only retain the most current copy of the manufacturer’s instructions for the test kit and controls.

Testing Area

• The testing area for the INSTI HIV-1 Antibody Test must meet the following minimum requirements:

o Room temperature within the operating range of the test (59-86°F). o Contain a stable work surface that can be covered with an absorbent under-pad. o Contain adequate seating for the client and pharmacist. o Within reach of appropriate materials, including one sealed test pouch containing INSTI

Membrane Unit, one vial of Sample Diluent, Color Developer, and Clarifying Solution, alcohol prep pad, lancet, and pipette

o Adequately lit to allow interpretation of the test result. As a rule of thumb, lighting is sufficient if standard newsprint held next to the text device can be read without difficulty. A mini flashlight can also be used to help read the testing device.

Preparing to Conduct the HIV Test

Patient Identification and Preparation • HIV tests are available to individuals 15 years of age and older. Rapid test kits currently

approved by the FDA only function when used with specimens from individuals over 13 years of age. If a family or guardian presents with an HIV testing need for a child under thirteen, they should not be referred to a community partner using the provided resource sheet. Instead, the following steps should be taken:

o The pharmacy should call IDPH staff to work through the case:

Cody Shafer 515-443-0341

• If an individual 15-17presents for a Rapid HIV testing, you may provide service as long as minor

understand a positive reactive test requires parental notification. A minor consent form (See

Attachment K Minor’s Consent Form) should be completed before testing.

• Any patient that is requesting an HIV Test as the result of sexual assault or worksite related needle-stick event are to be referred to the nearest emergency room for appropriate emergency care.

• It is required that the testing pharmacist take all documents and testing materials to the private consultation area. Patient privacy is essential for all steps of HIV education and testing.

• IT IS REQUIRED that prior to testing the patient receive and read the INSTI HIV-1 Antibody Test -- Subject Information Brochure titled “What You Should Know About HIV and the INSTI HIV-1 Antibody Test Before Testing.”

• Address any questions the patient may have about the test or the information contained in the pamphlet.

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Pre-Test Education and Documents to be Completed: • Patient education is critical when providing rapid HIV testing. All HIV testing sites will adhere to

the following guidelines: o The patient will be given information about the HIV test, its purpose, potential uses,

limitations and the meaning of its results. Patients will also be educated about the testing procedures to be followed, that the HIV test is voluntary, the right to withdraw from the testing before completion of the test and the right to confidential treatment of the test and test results, to the extent provided by applicable law.

o Manufacturers of rapid HIV tests, including INSTI HIV-1 Antibody Test, provide a subject information brochure that must be given to each patient prior to performing the test, in accordance with FDA sales restrictions.

o The patient is to be advised that their rapid test results will be made available to them during the same visit. The pharmacist will ask the patient if they are ready to receive test results within 1-3 minutes of starting the test. If the patient does not think they can receive test results on the same day the test is done, the pharmacy should recommend that the patient seek out traditional HIV testing.

o To provide the appropriate level of information for a potential HIV testing patient, the pharmacist should use the one-page process flow document titled: Pharmacist Testing Work Flow (see Attachment G).

• Patients being tested at the selected pharmacy locations must provide informed consent by completing the HIV Information and Testing Agreement.

• The testing pharmacist must record the use of a test kit on the INSTA Rapid HIV Test Usage Log Form.

Set Up and Preparation • Do not use the INSTI Membrane Unit or Solutions beyond the expiration date.

• Test development procedures are to be conducted in the private consultation area of the pharmacy.

• Cover the workspace area with a clean, absorbent pad.

• The testing pharmacist is to put on gloves prior to starting the testing process.

• Describe for the patient the collection procedure.

• After the patient confirms understanding of the test, open the INSTI HIV-1 Test Membrane Unit by tearing at the notches on the top of each side of the foil pouch. Do not touch the center well of the Membrane Unit. Do not use if the foil pouch has been previously opened or if the packaging integrity is compromised in any manner. Once the Membrane Unit has been opened, it must be used immediately.

• Place the Membrane Unit on the absorbent pad with the tab of the Membrane Unit facing the testing pharmacist.

• Remove one bottle of Sample Diluent (Solution 1), Color Developer (Solution 2), and Clarifying Solution (Solution 3) and place on absorbent pad. Remove one single-use precision pipette, lancet, and alcohol swab and place on absorbent pad.

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Performing the HIV Test

Specimen Collection and Handling • Pharmacists or pharmacist technician will only use Fingerstick Whole Blood Samples when

conducting rapid HIV tests.

• Choose a spot on the side of one of the center fingers (3rd or 4th finger) of the non-dominant hand. To help increase blood flow, the fingers and hand should be warm to the touch. Patients can rub their hands together, run under warm water in the restroom, or squeeze them together to increase blood flow to the capillaries in the fingertips.

• Clean the site with an alcohol swab. Wipe well to remove any glycerin-based soaps or lotions from the patient’s finger. Allow the site to dry completely to prevent additional pain.

• Use of the 21-gauge single-use lancet provided with INSTI test is necessary to collect the 50 μL of blood need to conduct the test. Twist and pull the green tip out of the single-use lancet. Place the lancet at the desired site and press firmly until you hear a click to puncture the skin. It is against best practices to use the lancets or lancing devices that are not single-use safety inserts to perform patient testing (i.e., blood glucose monitor lancets). This type of lancet and lancing device is intended ONLY for a single patient for at home use.

• Discard the lancet into the biohazard waste container immediately after use.

• Squeeze the finger gently to create a drop of blood. Wipe away the first drop of blood, as it may contain tissue fluid.

• Squeeze the finger gently again while holding it downward until a large drop of blood forms. Apply pressure proximal to the site using thumb and forefinger of non-dominant hand to keep a bead of blood forming.

• Place the pipette tip horizontally into the blood bead. The pipette tip must be completely submerged in blood for the capillary action to work and draw the blood to the black fill line. Do not squeeze the pipette bulb or cover the air hole between the black lines.

• Fill the pipette to the black line to obtain 50 μL of blood.

• If an air bubble develops on the end of the pipette tip or if the blood stops moving up the pipette, gently wipe the tip of the pipette with a gauze pad. Wipe the patient’s finger with a gauze pad and squeeze the finger until a large drop of blood forms again.

• If the volume of blood is inadequate, perform and second finger puncture using a new lancet and pipette.

• Wipe off any excess blood from the finger and have the patient apply pressure to the puncture until the bleeding stops and then bandage the patient’s finger.

Running the Test

• Once the pipette is filled to the black line, the blood specimen will be transferred to the Sample Diluent.

• Open the Sample Diluent (Solution 1) and align the tip of the pipette with the Sample Diluent. Squeeze the bulb of the pipette to transfer the blood specimen to the Sample Diluent. If the blood specimen does not release, cover the air hole on the black line with your fingers and squeeze again.

• Recap the Sample Diluent bottle and mix by inversion for 5 seconds.

• Pour the entire contents of the Sample Diluent bottle to the center of the Membrane Unit well.

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o This must be done within 5 minutes of adding the Positive Control specimen to the Sample Diluent. The mixture should be absorbed through the membrane in less than 30 seconds; however, absorption times will vary slightly. Allow the solution to be absorbed completely, then immediately proceed to the next step.

o IMPORTANT: If at any period during the testing, the Sample Diluent, Color Developer, or Clarifying Solution stop flowing through the Membrane Unit, the procedure must be stopped and re-started with new INSTI components. The pharmacist should record the lot number of the test kit, and contact IPA’s Lead Project Manager at 515-270-0713 or kstaiert@iarx.org, who will convey that information to the test manufacturer. If two kits within the same box present this abnormality, testing shall cease and the Lead Project Manager will obtain a new lot of test kits for the pharmacy.

• Re-suspend the Color Developer (Solution 2) by inversion for 5 seconds. Open the Color Developer and add the entire contents to the center of the Membrane Unit well. The colored solution should flow through completely in about 20 seconds. Allow the solution to be absorbed completely, then immediately proceed to the next step.

• Open the Clarifying Solution (Solution 3) and add the entire contents to the center of the Membrane Unit well. This will reduce the background color and facilitate reading of the test result. Immediately read the result once the solution is through the well.

o DO NOT read the results if more than 5 minutes have elapsed following addition of Clarifying Solution

Test Result Interpretation • Read the results immediately after absorption of the Clarifying Solution.

• DO NOT read the results if more than 5 minutes have elapsed following addition of the Clarifying Solution.

NON-REACTIVE REACTIVE INVALID

Appearance of Result The c\control spot at the top of the read frame furthest from the plastic tab on the Membrane unit shows blue color development AND NO blue spot is visible at the test spot, located below the control.

The control spot AND the test spot show blue color development. NOTE: One spot may be darker than the other.

The test is invalid if any of the following occurs:

• There is no blue color on the control spot or test spot

• There is blue color on the test spot, but not the control spot

• There is a uniform tint across the membrane

• Only blue specks appear on the membrane

HIV Antibodies A Non-Reactive test result means that HIV-1 antibodies were not detected in the specimen.

A Reactive test result means that HIV-1 has been detected in the specimen.

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Interpretation Negative for HIV-1. PRELIMINARY POSITIVE for HIV-1 antibodies.

An Invalid test result cannot be interpreted. The test was run incorrectly or insufficient specimen was added.

Repeat the test with a new specimen, Membrane unit, kit components, and supporting materials. Contact IPA’s Lead

Project Manager Support if the repeat test provides an Invalid

Test Result. Document on INSTI Rapid HIV Test Problem

Documentation

NON-REACTIVE REACTIVE INVALID

Counseling (See After Testing-Counseling on Results

Explain the meaning of the test result in simple terms, avoiding technical jargon. Convey that they are not infected with HIV, unless they have had a recent—within three (3) months—known or possible exposure to HIV.

Explain the meaning of the screening test result simple terms. Emphasize the need for confirmatory testing for a reactive (preliminary positive result).

Explain to the patient that the test must be repeated. It will be necessary to collect a new specimen and run a new test.

Referral If a patient falls within the three (3) month “window” period, recommend retesting. Explain that sufficient time needs to elapse before antibodies develop that can be detected by the test. Recommend retest in 3 months.

Provide patient with information to assist with confirmatory testing and linkage to care.

Refer patient to traditional HIV Testing sources if second test is invalid or patient refuses second test.

• If reactive positive, the testing pharmacist is to immediately transcribe the patient results on the:

o Rapid HIV Screening Case Report Form (Attachment B) o INSTI Rapid Test Kit Usage Log (Attachment F)

• To maintain patient privacy, record these results in the pharmacy out of the view of customers, other patients or other providers after testing has been conducted.

• All patient identifiable records are to be filed in a locked file cabinet in the pharmacy.

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Test Limitations

• Although the membrane contains HIV-1 and HIV-2 proteins, the assay has been validated for detection of HIV-1 antibodies only.

• For a Reactive result, the intensity of the test spot does not necessarily correlate to the titer of antibody in the specimen.

• Reading test results after more than 5 minutes has elapsed following addition of Clarifying Solution may yield erroneous results.

• Patients infected with HIV-1 or HIV-2 receiving Antiretroviral Therapy may produce false negative results.

• Specimens from patients with multiple myeloma may result in false Non-Reactive or Invalid results.

• Patients with elevated hemoglobin levels may test false Non-Reactive.

• A Non-Reactive Result does not preclude the possibility of exposure to HIV or infection with HIV. An antibody response to recent exposure may take several months to reach detectable levels.

• A person who has antibodies to HIV-1 is presumed to be infected with the virus, except if that person has participated in an HIV vaccine study may develop antibodies to the vaccine and may or may not be infected with HIV.

Counseling on Results

Confidentiality • Ensuring confidentiality of the patient is a critical part of providing HIV Testing Services. All

patient information is confidential, whether the patient is tested or decides to decline rapid HIV testing.

• Test results will be shared only with the patient and cannot be shared with others, with the exception of required disclosure to the Iowa Department of Public Health. In the event that a patient requests to have their test result shared, they must provide a signed Authorization of Release of Information, which names the specific party to whom disclosure is permitted, prior to information disbursement. A private consultation room is required for all other disclosures without written patient approval.

• Releasing of test results or any information leading to disclosure of the identity of a patient without the written consent of the patient is a breach of confidentiality and punishable by applicable State statutes and administrative regulations.

• Pre-test and post-test education must be performed in a private area or room with a closed door, where no one can see the specimen collection and testing being done or hear the conversation. (Counseling must always be done one-on-one to determine informed consent.)

• Files and logs with identifying patient information will be kept in a locked cabinet in the pharmacy. These files are only accessible to the testing pharmacists.

Post-test Education: Communicating the Meaning of Rapid HIV Test Results to Patients • The pharmacist that conducts the testing will be responsible for communicating the results of

the rapid HIV test to the patient. It is important to keep in mind that the rapid HIV test is a

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screening test, and the patient who tests preliminary positive need to have their test results validated with a confirmatory test.

• Guidelines follow for conveying test results to patients receiving HIV testing. o Negative (Nonreactive) Rapid HIV Test Result

▪ For patients with a negative (nonreactive) test result, it is essential to:

• Explain the meaning of the test result in simple terms, avoiding technical jargon.

• Convey that they are not infected with HIV, unless they have had a recent—within three (3) months—known or possible exposure to HIV.

• If a patient falls within the three (3) month “window” period, recommend retesting. Explain that sufficient time needs to elapse before antibodies develop that can be detected by the test.

• Underscore the importance of taking precautions to avoid becoming infected with HIV. Provide patient with the written patient education piece titled HIV Risk Reduction Patient Education.

• All patients that receive rapid HIV testing are to receive patient education piece titled HIV Risk Reduction Patient Referral Card (see Attachment M). This patient education piece also contains local referral sources for HIV counseling.

o Preliminary Positive (Reactive) Rapid HIV Test Result ▪ For patients with a preliminary positive (reactive) test result, it is essential to:

• Provide reactive result to this screening test clearly and simply.

• Explain the meaning of the screening test result in simple terms.

• Emphasize the need for confirmatory testing.

• Assess how the patient is coping with the result.

• Advise the patient to take precautions to avoid transmitting infection to other while awaiting results of confirmatory testing.

• Further testing is always required to confirm a preliminary positive (reactive) test result. Testing pharmacists need to keep in mind that providing preliminary positive results to patients without the benefit of a same-day confirmatory test can be a challenge. For all patients with a preliminary positive test result, it is essential to:

o Explain the meaning of the test result in simple terms, avoiding technical jargon. Use language to convey the probability that the patient is infected with HIV, e.g., infection is “possible, likely, or probable.”

o Emphasize the importance of confirmatory testing and provide a referral for confirmatory testing. Provide referrals to the patient, as appropriate, if they are experiencing anxiety and stress related to having to get a confirmatory test.

o Underscore the importance of taking precautions to avoid the possibility of transmitting infection to others while awaiting results of confirmatory testing. Provide patient with written information about risk reduction.

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o A simple, straightforward message to convey this information could be “Your preliminary test result is positive, but you won’t know for sure if you are infected with HIV until you get the results from your confirmatory test. In the meantime, you should take precautions to avoid transmitting the virus.”

o All patients that receive rapid HIV testing are to receive the (city/state specific) patient education piece titled Rapid HIV Testing Patient Education. This patient education piece also contains local referral sources for HIV counseling.

o Invalid Rapid HIV Test Result ▪ While an invalid test result occurs rarely, it is a possibility. If a patient has an

invalid test result, it is essential to:

• Explain to the patient that the test must be repeated. It will be necessary to collect a new specimen and run a new test.

• Explain to the patient the reasons why the test could not be interpreted. Invalid tests occur because the test was run incorrectly or insufficient specimen was added.

• Assure the patient that quality control measures are in place in order to accurately conduct the test.

• Be sure the patient understands that an invalid test is not a positive or a negative result. Something happened to render the test invalid and this is unrelated to the patient’s HIV status.

• If the patient does not have the time for another test, they will be scheduled to return on another day.

Referrals for Confirmatory Testing

• Pharmacists involved with this service are responsible for the coordination of confirmatory testing for any patient who receives a preliminary reactive test result. (See Attachment D– Pharmacist Referral to Confirmatory Testing). Pharmacists will use the Coordination of Confirmatory Testing Agreement (CCTA) form (see Attachment I) to refer patients to testing with a partner agency or IDPH funded test site.

• After providing the appropriate post-test counseling to the client, the pharmacist should decide whether he/she will provide a direct referral to the client or facilitate a referral to an IDPH funded facility with Coordination of Confirmatory Testing Agreement (CCTA).

• If the pharmacist prefers to provide a direct referral with a collaborative practice agreement with a local provider, (See Attachment H)– Collaborative Practice Agreement) he/she should:

o Review collaborative practice agreement for referral process. o Call the provider the pharmacy has the collaborative practice agreement with. o Schedule confirmatory test for the patient - linkage to care. o Indicate the link to confirmatory test on the bottom of the Rapid HIV Testing Case

Report Form. o Write the appropriate time, date and location of confirmatory test appointment on the

Referral to Confirmatory Test card (see Attachment J).

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• If the pharmacist prefers to refer patient to an IDPH funded facility, he/she should: o Access the IDPH Funded Test Site list (see Attachment L) for facilities in their region. o Call the nearby IDPH funded test site. o Schedule confirmatory test for the patient - linkage to care. o Indicate the link to confirmatory test on the bottom of the Rapid HIV Testing Case

Report Form. o Write the appropriate time, date and location of confirmatory test appointment on the

Referral to Confirmatory Test card (see Attachment J).

Patient Failure to Return for Test Results It is possible that the patient being tested is not prepared to receive their test results. In the event that patient leaves the pharmacy before receiving their results the follow procedures are to be followed. Upon Patient Return to the Pharmacy:

• If the patient returns to the pharmacy to receive their results, the pharmacist will confirm the patient’s identify with a photo ID.

• After photo ID verification, a HIV testing trained pharmacist will locate the patient’s HIV Information and Testing Agreement form.

• Any pharmacist trained on HIV testing can provide the information to the patient, the pharmacist that conducted the test is not required to be the pharmacist to share the information.

• The HIV testing trained pharmacist will provide the patient’s results in the private consultation area and complete post-testing procedures, as described in the procedures provided previously.

Biohazard and Waste Disposal • Dispose of the lancet device, membrane unit, solution vials, and expired control solutions, into

the biohazard container.

• The absorbent pad and gloves can be discarded in the regular trash.

• Upon their expiration, test kits can be discarded in the regular trash.

• After disposing of gloves and the testing pharmacist is to wash his/her hands.

• Disassemble testing area and clean with VDH-provided disinfecting wipes. Allow 60 minutes for effective decontamination.

Device Care • The HIV Testing supplies do not have return privileges and should be discarded by the following

procedures: o Expired rapid HIV test kits are to be discarded in the regular trash. o Expired control solutions are to be discarded into a sharps container.

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Appendix and Resources

Iowa Pharmacy Association

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ATTACHMENT A

Iowa Pharmacy Association: HIV/Hepatitis C Initiative

Community Services Agreement

THIS SERVICES AGREEMENT (this “Agreement”) is entered into effective as of the September 1, 2018 by

and between ___________PHARMACY NAME (“Community”), with a principal place of business located at

_______________ADDRESS OF COMMUNITY and the Iowa Pharmacy Association (“IPA”), a not for profit

501(c)(6) organization organized under the laws of the State of Iowa, with its principal place of business located

at 8515 Douglas Avenue, Suite 16, Des Moines, IA 50322.

WHEREAS, IPA is implementing an initiative, known as “HIV/Hepatitis C Initiative” (the “Project”),

that aims to improve HIV and Hepatitis C routine screening rates and reducing the gap in linkage to care for

adults in the state of Iowa.

WHEREAS, Community has been selected by IPA to participate in the proposed Project, and the Community

wishes to participate in the Project under the terms and conditions of this Agreement; and WHEREAS,

Community has agreed to identify 1 location to participate in the Project.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are

hereby

acknowledged, IPA and Community (each a “Party” and collectively, the “Parties”) agree as follows:

1. DEFINITIONS

1.1. “Inclusion Criteria: Any individual who consults with the pharmacy is eligible to participate in the HIV/Hepatitis C Initiative, while targeted population demographics will be provided by the Iowa

Department of Public Health.

1.2. “Participant” means any individual who meets the Inclusion Criteria specified for the Project.

1.3. “Data Collection Period” means the 3-year period for service provision (expected October 1, 2018 to September 30, 2021). This may be renewable based on grant funding.

2. DUTIES OF COMMUNITY

2.1. Operations of Routine Screening

2.1.1. Each community must already have an established routine screening program in place.

2.1.2. Each community is responsible for ensuring their routine screening practice operates in compliance with all federal and state statutes, laws and regulations.

2.1.3. Each community is responsible for ensuring their protocols are up-to-date and filed according to the laws and regulations governing their practice.

2.1.4. Each community must be capable of said HIV or Hepatitis C routine screenings.

2.1.5. Each community is responsible for ensuring all pharmacists conducting screenings within the community have been properly trained on testing equipment, technique and emergency

response protocols and practice within their scope of practice.

2.2. Designation of a Community Champion

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2.2.1. Each community will designate a Community Champion within the practice site that will be the main contact person for IPA. The Community Champion will be responsible for:

• Implementing the initiative within their site

• Participating in required monthly project meetings (to be held by conference call)

• Communicating with the IPA staff as needed

• Ensuring required data is submitted to IPA on behalf of the community

• Resolving any data discrepancies as needed

2.3. HIV/Hepatitis C Initiative Training and Implementation.

2.3.1. The Community Champion will attend one day of training in September 2018 which will provide training and education about how the project will be implemented within the sites.

Each pharmacy is allowed to send two pharmacists or other staff member to attend the

training. Each participant will be compensated $150 for attending and completing the

training.

2.3.2. The Community Champion will train all pharmacists and staff about the innovative practice model so it will be implemented consistently throughout the practice (A policy and

procedures manual will be provided at training).

2.4. Data Collection and Reporting. IPA will provide the required minimum data set for the Project to all Communities as provided by the Iowa Department of Public Health (the minimum data set

will be described at training).

2.4.1. The community must be willing to submit quantitative and qualitative data for data analysis during the data collection period.

2.4.1.1.Qualitative data (e.g., assessment of current model of practice and

barriers to routine screening practice, quality assessment of the innovative

practice model) will be conducted pre-project, at the midpoint, and at project

completion.

2.4.1. 2.Quantitative data (e.g., screening rates, pharmacist interventions made at the screening and follow-up) will be collected through pharmacist documentation pre-project, at the

midpoint, and at project completion.

2.4.2. The community must be willing to work with IPA to resolve any data discrepancies in a timely manner.

2.4.3. The community must be willing to allow IPA to disseminate aggregated data from the project to important routine screening stakeholders.

2.5. Membership in IPA.

2.5.1. All full-time pharmacist employees of Community shall maintain active individual membership in IPA throughout the entire length of the initiative.

2.5.2. At least one pharmacy technician of Community shall maintain active individual membership in IPA throughout the entire length of the initiative.

3. DUTIES OF Iowa Pharmacy Association

3.1. Community Training. IPA shall provide project implementation training for the designated Community Champion prior to project initiation.

3.2. Support Mechanisms. IPA shall provide the following support mechanisms to assist the Community in its participation in the Project:

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3.2.1. IPA’s Lead Project Manager will provide programmatic support by telephone and e-mail. Iowa Department of Public Health will designate regional Disease Intervention Specialists,

Health Educators and Rural Outreach Liaisons that will provide community-level coaching

and support as needed by each Community.

3.2.2. IPA will contract with the Iowa Department of Public Health that supports data collection, grant funds, routine screening testing supplies, and training materials, ongoing support, and

troubleshooting to the communities throughout the duration of the project.

3.3. Regulatory Approvals. IPA shall obtain all approvals required by law for the Study.

4. COMMUNITY BENEFITS.

4.1. Community Benefits. In consideration for its participation in the Project, IPA shall:

4.1.1. Provide the Community with a $1,000 incentive. IPA will distribute the $1,000 grant funding as follows:

4.1.1.1.$500 grant payment upon execution of this Agreement and completion of

project training.

4.1.1.2.$500 grant payment upon submission and successful reconciliation of the

data for a target of 50 patients at the end of year one.

4.1.1.3.A similar grant payment will be made for subsequent years for those

participating in this initiative and successful reconciliation of the data for a target

of 50 patient annually.

4.2. Use of Grant Monies. The grant monies must be used and spent by Community for direct expenses of Community in the execution of Community’s duties for the Project and as provided in this

Agreement unless approved in writing by IPA.

4.3. Taxes and Employee Benefits. Community will be solely responsible for the payment of all taxes, and its employees’ salaries, unemployment insurance, worker’s compensation, employee benefits

and other employment-related charges and deductions.

5. TERM AND TERMINATION.

5.1. Term. The term of this Agreement will begin on September 1, 2018 (the “Effective Date”) and continue in force until September 30, 2021, unless terminated in accordance with this Section 5

(the “Term”).

5.2. Termination for Convenience. Either Party may terminate this Agreement for convenience by providing the other Party with thirty (30) business days’ prior written notice of such termination.

5.3. Termination for Material Breach. In the event of any material breach of this Agreement, the non-breaching Party may terminate this Agreement by giving ten (10) business days prior written

notice to the other Party; provided, however, that this Agreement will not terminate if the other

Party has cured the breach before the expiration of such ten (10) business day period.

5.4. Termination for Insolvency. This Agreement is terminable immediately without notice by a Party if the other Party: (i) voluntarily institutes insolvency, receivership or bankruptcy proceedings, (ii)

is involuntarily made subject to any bankruptcy or insolvency proceeding and such proceeding is

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not dismissed within sixty (60) days of the filing of such proceeding; (iii) makes an assignment for

the benefit of creditors, or (iv) undergoes any dissolution or cessation of business.

5.5. Survival. The provisions of Section 6 (“Intellectual Property”), Section 7 (“Confidentiality”), Section 8 (“Participant Information and HIPAA”), Section 9 (“Representations and Warranties”),

Section 10 (“Indemnification”), Section 11 (“Liability”), and Section 12 (“Miscellaneous

Provisions”) shall survive the expiration or termination of this Agreement for any reason.

6. INTELLECTUAL PROPERTY. Neither Party transfers or licenses to the other Party any rights in or to its patents, patent applications, copyrights, trademarks, trade secrets or other intellectual property rights

(collectively, “Intellectual Property Rights”). IPA retains all Intellectual Property Rights to any Project

related materials provided to Community hereunder.

7. CONFIDENTIALITY.

7.1. Definition of Confidential Information. For the purposes of this Agreement, “Confidential Information” means information that is disclosed by either Party in connection with this Agreement

that is marked as “Confidential” or with a similar legend (or if disclosed orally, is identified by

written notice as being confidential information within ten (10) business days after disclosure) or

information that is disclosed by either party that the other party should know that, by its nature, is

confidential. Notwithstanding the foregoing, Confidential Information does not include information

which: (i) is or becomes public knowledge without any action by, or involvement of either Party;

(ii) is disclosed by one Party with the prior written approval of the other Party; (iii) is independently

developed without use of Confidential Information.

7.2. Restriction on Use and Disclosure. The Parties agree: (i) not to disclose the Confidential Information to anyone other than its employees or advisors without prior written permission, such

permission not to be unreasonably withheld; (ii) not to use the Confidential Information, except as

required to perform any obligations under this Agreement; and (iii) to ensure that any of its

employees or advisors who receive access to Confidential Information are advised of the

confidential and proprietary nature thereof and are prohibited from copying, utilizing or disclosing

Confidential Information, except as required to perform any obligations under this Agreement.

7.3. Standard of Care. The Parties agree to employ with regard to the Confidential Information procedures that are no less restrictive than the procedures used by it to protect its own confidential

and proprietary information of similar sensitivity (and that in no event are less restrictive than

reasonable procedures).

7.4. Required Disclosures. If either Party is requested to disclose any of the Confidential Information pursuant to any judicial or governmental order, the requesting Party will, to the extent reasonably

feasible, give the other Party written notice of the request and opportunity to contest the order prior

to disclosing the Confidential Information.

8. PARTICIPANT INFORMATION AND HIPAA.

8.1. Each Party acknowledges that the protection of participant privacy is of the utmost importance for the success of the Project. Neither party shall disclose Protected Health Information (“PHI”), as

that term is defined by HIPAA and its implementing regulations, of any Project Enrolled Participant

to any third person unless such Enrolled Participant has provided his or her prior HIPAA compliant

authorization.

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8.2. “Participant Information” shall include PHI and any and all information regarding Community’s Participants. Neither Party shall create, divulge, transfer, disclose, use, maintain, alter, or

communicate in any manner any Participant Information except in accordance with the laws and

regulations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), Public

Law Number 104-191, as amended. Any disclosure of Participant Information by either Party will

be in accordance with all applicable federal and state laws, rules and regulations. As required by

45 C.F.R. § 164.504(e)(2)(ii)(H), upon request from the Secretary of the U.S. Department of Health

and Human Services, a Party will make its internal practices, books, and records relating to the use

and disclosure of Participant Information received from, or created or received by it on behalf of

the Participant, available to the Secretary for the purpose of determining the Parties’ compliance

with 45 C.F.R. § 164.504. If either Party receives such a request, that Party shall notify the other

Party in writing. A violation of this Section 8 shall be a material violation of this Agreement. This

Section 8 shall survive the expiration or termination of

this Agreement. Both Parties shall be bound by the terms and conditions of the Business

Associate Agreement attached hereto and incorporated herein as Appendix D.

9. REPRESENTATIONS AND WARRANTIES.

9.1. Mutual Representations and Warranties. Each Party represents and warrants that as of the Effective Date and at all times thereafter:

(a) this Agreement constitutes its valid and binding obligation and is enforceable against it in

accordance with the terms of this Agreement; and

(b) the execution and delivery of this Agreement by it and the performance of its obligations

hereunder: (i) are not in violation or breach of, and will not conflict with or constitute a

default under, any material contract, agreement or commitment binding upon it; and (ii)

will not conflict with or violate in any material manner, any applicable law, rule, regulation,

judgment, order or decree of any government, governmental instrumentality or court

having jurisdiction over such Party.

9.2. Warranty by Community. Community hereby warrants to IPA that Community’s participation in the Project shall be performed in a competent, workman-like manner, in accordance with current

industry standards.

9.3. Disclaimer. Except for the express warranties stated in this Sections 3 and 9, each Party disclaims all other warranties, whether implied by operation of law or otherwise, including, without

limitation, any implied warranties of merchantability and fitness for a particular purpose, and any

warranties arising from a course of performance, course of dealing or usage of trade.

10. INDEMNIFICATION. Each Party (an “Indemnitor”) will indemnify, defend and hold harmless the other Party and its affiliates and each of their respective trustees, officers, directors, members, managers,

employees and agents (each, an “Indemnitee”) from and against any claim, suit or proceeding brought by

a third party against an Indemnitee to the extent that it arises out of or relates to (i) the Indemnitor’s

breach of any representation or warranty made under this Agreement, or (ii) the negligent or willful

misconduct of the Indemnitor or its agents in connection with this Agreement, and shall pay all costs

incurred by (including reasonable attorney’s fees and disbursements) and damages awarded against the

Indemnitees, but shall not be responsible for any compromise or settlement made without the

Indemnitor’s consent. The Indemnitee shall promptly notify the Indemnitor in writing of any claim, suit

or proceeding that the Indemnitor may have obligations under this Section 10; provided, however, that

any failure of the Indemnitee to provide prompt written notice pursuant to this Section 10 shall excuse the

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Indemnitor only to the extent that it is prejudiced thereby. The Indemnitee seeking indemnification

hereunder shall cooperate with the Indemnitor with regard to the defense of any claim, proceeding, suit or

threatened suit. The Indemnitor shall have full control of any such claim, proceeding or suit and the

authority to settle or otherwise dispose of any suit or threatened suit. In no event, however, may the

Indemnitor agree to any settlement of any claim, suit or proceeding for which it has agreed to provide

indemnification under this Agreement if such settlement would impose any liability or obligation upon

the Indemnitee, without the Indemnitee’s prior, written consent.

11. LIABILITY.

11.1. Liability Exclusion. No Party will be liable to the other Party (nor to any person claiming rights derived from such other Party’s rights) for any indirect, incidental, consequential, special, punitive

or exemplary damages of any kind (including without limitation lost revenues or profits, loss of

use, loss of cost or other savings or loss of goodwill or reputation) with respect to any claims based

on contract, tort or otherwise (including negligence and strict liability) arising out of or relating to

this Agreement, regardless of whether the Party liable or allegedly liable was advised, had other

reason to know, or in fact knew of the possibility thereof.

11.2. Exceptions. Notwithstanding anything to the contrary, the exclusions and limitations of liability set forth in this Section 11 shall not apply: (i) to the Parties’ respective obligations of confidentiality

under Section 7, (ii) to any obligations under Sections 8, 9, and 10, or (ii) to the extent that acts or

omissions of a Party constitute gross negligence or willful misconduct.

12. MISCELLANEOUS PROVISIONS.

12.1. Relationship Of The Parties. Each Party is an independent contractor of the other Party. Nothing in this Agreement will constitute a partnership between or joint venture by the Parties, or constitute

either Party the agent of the other.

12.2. Governing Law. This Agreement, and any and all disputes arising from or relating to this Agreement, will be governed by and construed under the laws of the State of Iowa without reference

to its conflicts of law principles.

12.3. Resolution of Disputes. Any dispute, claim or controversy that may arise in connection with this Agreement shall be first negotiated in good faith by the Parties, and if such negotiations do not

result in a mutually agreeable resolution, either Party may bring a claim against the other Party.

12.4. Force Majeure. Except with respect to failure to pay any amount due under this Agreement, nonperformance of either Party shall be excused to the extent that performance is rendered

impossible or materially impacted by strike, fire, flood, governmental acts, orders or restrictions,

failure of suppliers, or any other reason where failure to perform is beyond the reasonable control

and not caused by the negligence of the non-performing Party.

12.5. Assignment. Neither Party shall assign or otherwise transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party. Any assignment,

subcontracting or other transfer not in accordance with this Section 12.5 shall be null and void.

12.6. Successors and Permitted Assigns; Third Party Beneficiaries. This Agreement is binding upon and will inure to the benefit of each Party and their respective permitted successors or assigns.

Nothing in this Agreement, express or implied, is intended to confer upon any other person any

rights or remedies of any nature whatsoever under or by reason of this Agreement.

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12.7. Entire Agreement. This Agreement sets forth the entire agreement and understanding of the Parties relating to the subject matter herein and merges all discussions, representations, covenants,

promises, discussions, negotiations, and exchanges between them with respect thereto.

12.8. Modification and Waiver. No modification of or amendment to this Agreement will be effective unless in writing signed by authorized representatives of both Parties. No waiver of any rights is

to be charged against any Party unless such waiver is in writing signed by an authorized

representative of the Party so charged.

12.9. Notices. All notices and other communications hereunder will be in writing and will be deemed effective when delivered by hand or by facsimile transmission, or upon receipt when mailed by

registered or certified mail (return receipt requested), postage prepaid, or by bonded overnight

courier, to the Parties at the addresses listed below (or at such other address for a Party as shall be

specified by written notice):

If to IPA: If to Community:

8515 Douglas Avenue, Ste 16

Des Moines, IA 50322 Attn:

Attn: Anthony Pudlo

12.10. Unenforceable Provisions. If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction, the other provisions of this Agreement will remain in full force

and effect, and, if legally permitted, such offending provision shall be replaced with an enforceable

provision that as nearly as possible effects the Parties’ intent.

12.11. Counterparts. This Agreement and any exhibit attached hereto may be executed in multiple counterparts (which may be exchanged by facsimile), each of which will be deemed an original and

all of which together will constitute one instrument.

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized

representatives

.

[Iowa Pharmacy Association]

By: ______________________________

Print Name: Anthony Pudlo

Title: Vice President, Professional Affairs

[Community]

By: ______________________________

Print Name: _______________________

Title: ____________________________

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ATTACHMENT B

43

ATTACHMENT C

HIV Information and Testing Agreement

Testing provided by ________________________________ Pharmacy is voluntary. By signing this form, you agree to take a test that will show if you have antibodies for HIV, the virus that causes AIDS. Antibodies are generated by your immune system every time it comes in contact with a new disease, which means that if you have antibodies for HIV, you are likely HIV-infected. Your body does not immediately develop antibodies, but produces them over the first 90 days of a new infection. Like a number of other communicable diseases, HIV is a reportable condition in the state of Iowa. This means that if you are diagnosed with HIV, your name and contact information will be reported to the Iowa Department of Public Health, who will help you get access to medical care. The health department will protect your identity and your records. People get HIV most often by having unprotected sex or sharing needles/syringes with an infected person. If you get HIV, it can take up to 90 days to develop antibodies. If you may have been exposed to HIV in the past 90 days, it is recommended that you test again in three months regardless of your test result. People who often engage in high-risk behavior should test every three months. With medical care, most people with HIV stay healthy for years. People who find out early have better health outcomes than people who find out after HIV has damaged their immune systems over a long period of time. People who know they have HIV can also avoid passing the virus to others. What Kind of Test Will Be Done? You are receiving a rapid test. Rapid tests are simple and accurate when performed at point-of-care by personnel trained to follow manufacturer’s instructions. Your pharmacist has been specially trained to conduct your HIV test, and will use a fingerstick lancet to collect a blood specimen. The results of your rapid test will be ready in 1-3 minutes. If you do not think you can receive the test results on the same day the test is done, we recommend you seek out traditional HIV testing. What does my Test Result Mean? If your rapid HIV test is negative, no antibodies for HIV were found. However, if you recently (within last 90 days) had unprotected sex or shared needles/syringes, there is a chance that you may be in the “window period”. This means that you may be infected, but have not yet developed the antibodies that will allow your test to yield an accurate result. If your rapid test is reactive or preliminary positive, you will need a confirmatory, or follow-up test, to verify the result of the first HIV test. Your testing pharmacist will refer you to a local provider or to a nearby organization funded by the Iowa Department of Public Health department for a confirmatory test. The follow up test will be a conventional test, which must be sent to a laboratory. You will need to return within 7-10 days to get your test results. If your confirmatory test is indeterminate, it may mean that you are still in the process of developing antibodies. It is important that you retest.

Signature: __________________________________ Date: __________ Printed Name: ____________________________________________________

44

ATTACHMENT D

45

ATTACHMENT E

INSTI Rapid HIV Testing Quality Issue Report

Rapid HIV Testing Quality Issue Report Form

Date of Test Testing Location

Test Kit Lot Number Testing Technician

Please answer the following questions to aid in the technical support assessment and recommendations.

Test Result Reactive Invalid Non-Reactive

Please briefly describe

the issue and document

any steps that were

taken as a result of the

situation.

46

ATTACHMENT F INSTI RAPID HIV TEST USAGE LOG

Test Date Lot # Test Start

Time

Test Read

Time

Test Result

N = Non-

Reactive

R = Reactive I =

Invalid

Initials of

Person

Who

Performed

Test

47

ATTACHMENT G

48

ATTACHMENT H

Collaborative Practice Agreement *unedited

Confirmatory Lab Testing of HIV Positive Patients Collaborative Practice Agreement (Clinic/Pharmacy name here)

PHARMACY NAME: Address: Contact Information: Purpose The Purpose of this agreement is to improve access to HIV medication therapy and ensure safe and appropriate medication use for treatment in patients diagnosed with HIV.

Goal

• To refer patients for diagnostic lab testing for HIV after initial screening test.

Providers Authorized The subsequent list of pharmacists are authorized on the basis of this collaborative practice agreement to order labs, for HIV diagnosis in Iowa under the medical direction of ________________________(SUPERVISING PHYSICIAN), __________________________(PHYSICIANS TITLE) for ______________________(PHYSICIANS PRACTICE NAME). Registered Pharmacists:

Last Name First Name License Number

*These pharmacists have met one or more of the following criteria:

• Graduation from a recognized college of pharmacy with a doctor of pharmacy (Pharm.D.) degree

• Certification by the Board of Pharmaceutical Specialties (BPS)

• Successful completion of a National Institute for Standards in Pharmacist Credentialing (NISPC) disease state management examination and credentialing by the NISPC

• Successful completion of pharmacy residency program accredited by the American Society of Health-System Pharmacists (ASHP)

• Approval by the board of pharmacy

49

Patient Population Patients may self-refer as long as they are a mutual patient of the ___________________________(PHARMACY NAME) and ________________________________(SUPERVISING PHYSICIAN). Patients may also be referred by the supervising physician to be managed by pharmacist following this agreement. Pharmacist Responsibilities Authorized by this Agreement

• The initial visit should consist, at a minimum, a review of the patient’s current medical conditions, medications, allergy history, and substance use.

• The pharmacist will order confirmatory serologic tests on behalf of the supervising physician if the patient tests positive on a Rapid HIV Test.

• The pharmacist should be aware of the possibility of acute HIV infection and false testing results. Patients suspected of recently acquired HIV infection should be referred immediately to their supervising physician

• Upon receipt of HIV positive confirmatory laboratory tests, the pharmacist will work with the supervising physician to contact provider to refer into office for linkage to care and determine an appropriate therapy regimen based off the current AIDS info/NIH guideline recommendations

Patient Education

• Education will be provided verbally and written handouts provided as appropriate.

• Written education may be provided through FDA approved medication information or AIDSinfo/NIH documents which can be found at https://aidsinfo.nih.gov/understanding-hiv-aids/infographics

• Education will include the following o Medication education o Safe-sex counseling, Info regarding the Undetectable = Untransmittable (U=U) prevention

access campaign Supervising Physician Responsibilities The referring provider is responsible for the overall supervision of the patient’s care and must maintain an ongoing relationship with the patient in order for the patient to receive pharmacist care pursuant to this agreement. The referring provider may withdraw the patient from the agreement at any time he/she deems necessary Documentation/Communication

• The pharmacist and/ or the supervising physician will inform the patient that care is being provided on a collaborative basis pursuant to this agreement

• The pharmacist shall document all assessment, lab/medication orders, and follow up in the patient’s health record and communicate this documentation to the supervising physician.

• The pharmacist shall initiate additional communication with the supervising physician under the following circumstances:

o Therapy discontinuation o Positive or critical laboratory r