Participation terms & conditions for the Hyperkalemia Early Detection Program for (Healthcare Hospitals).

• The Egyptian Society of Cardiology (EgSC), in collaboration with AstraZeneca, is implementing a hyperkalemia early detection program for high-risk patients (including patients with chronic kidney disease, heart failure and those on dialysis) with total available numbers of 3750 Tests
• Participation in this program is voluntary for healthcare Hospitals, and the potassium tests are provided free of charge to eligible patients, fully sponsored by AstraZeneca through EgSC.
• By applying to this website, the healthcare Hospital agrees to the following terms, conditions and responsibilities.
• Allocation of these services to hospitals will follow a first-come, first-served basis to ensure equity and transparency in access and distribution, determined by the date and time of receipt of a complete and compliant request for such Services.

The Hospital must fulfill the following conditions:

1. Patient pool Availability: The Hospital demonstrates a sufficient pool of appropriately targeted patients. (eligible high-risk patients including CKD, heart failure and dialysis patients)

2. Clinical Infrastructure and Capability: The Hospital possesses clinical infrastructure and access to accredited laboratory services (including technicians and sufficient cadre of qualified healthcare professionals). The Hospitals will perform structured mentoring for the device and tests used upon receiving patient referral free test voucherThe Hospital will accelerate the patient’s results pathway and will provide monthly aggregate reports to the EgSC.  

3. Established Hyperkalemia (HK) Management Protocols

1. Access to Care and Care Continuity: The Hospital ensures timely patient access, with streamlined referral workflows, insurance/coverage navigation, and GDMT implementation. 
2. The Hospitals demonstrate the Capacity and commitment to perform and report a high volume of diagnostic tests within an accelerated timeframe. The Hospital shall have the capacity to perform a minimum throughput of 100 patients per month and up to 1000 free potassium (POC) tests be conducted within a three-month period), can be increased upon availability & it is provided free of charge to patients, with no direct or indirect financial contribution requested from them in relation to these tests. If the Hospital does not meet this minimum on a sustained basis, the device and associated tests may be reallocated to another eligible Hospital 
3. The designated Hospital is responsible for informing patients that the service is provided free of charge and for authorizing the dissemination of materials containing  the disclaimer on such free of charge service

The Hospital is solely responsible for:

• • Identifying and enrolling eligible for high-risk patients (e.g. CKD, heart failure, dialysis) according to the program criteria.
  • Obtaining and documenting patients’ informed consent for sample collection, potassium testing, and the use of their data in an anonymized/aggregated form for program reporting.
  • Performing sample collection, point of care testing upon receiving patient’s referral free test vouchers and interpretation of results according to applicable clinical standards and internal protocols.
  • Providing appropriate clinical follow-up, safety, monitoring and medical management for patients identified with Hospital hyperkalemia management protocols.
• The Hospital retains full responsibility for clinical decisions, patient care, and patient safety; neither EgSC nor AstraZeneca will be involved.
• The Hospital will ensure that all healthcare professionals using the device are appropriately trained on its use and in the associated testing procedures.

• The hospital is responsible for providing vouchers received from Astrazeneca to patients with free of charge disclaimer and Consent to HCPs to provide it to the patients for screening tests.
•  

– Device custody and use

• The point of care potassium testing device provided within the Program is supplied to the Hospital as a temporary custody item for the duration of participation in the Program only.
• The Hospital agrees to:
  • Use the device solely for patients enrolled in this hyperkalemia early detection Program.
  • Store, handle and maintain the device and consumables in accordance with the manufacturer’s instructions and applicable laws and regulations.
• The device remains on the property of the providing party (EgSC or its delegate) and must be returned in good working condition at the end of the Program or upon request from EgSC.
• In case of loss or damage beyond normal wear and tear, the Hospital acknowledges its responsibility and undertakes to cooperate with EgSC to return or replace the device according to the applicable agreement between EgSC and the hospital.

– Data privacy and confidentiality

• The Hospital is responsible for protecting patients’ personal data in compliance with applicable data protection and privacy laws and its internal policies.
• The healthcare facility will not share, disclose, or provide access to any patient-identifiable data to AstraZeneca.
• Only anonymized/aggregated data (with no patient identifiers) will be reported to EgSC as part of the Program reporting.
• The Hospital will ensure that the patient information sheet and consent form clearly explain:
  • The purpose of the test and the Program.
  • The type of data to be collected and that only anonymized/aggregated data will be used for Program analysis and reporting.

– Aggregate reporting:

• The Hospital commits to providing EgSC with monthly aggregate reports within the last week of each calendar month for the duration of the Program.
• At a minimum, each monthly aggregate report should include:
  • Total number of patients screened for hyperkalemia using the Program device/tests.
  • Number of patients with confirmed hyperkalemia, stratified by risk group (e.g. CKD, heart failure, dialysis).
• Data must be provided in aggregate form only, without any personal identifiers.

– Relationship with EgSC and AstraZeneca

• The Hospital acknowledges that:
  • The legal and contractual relationship for this Program is between the Hospital and EgSC.
  • EgSC is responsible for coordination of the Program, including hospital selection based on pre‑defined criteria, and collection of aggregate data.
  • AstraZeneca is a non‑promotional partner for this Program, provides financial support and/or devices/tests through EgSC, and is recognized as a partner on Program materials.
• The healthcare facility agrees to allow EgSC to display AstraZeneca as a Program partner on non‑promotional materials related to the Program, in line with applicable industry codes and regulations.

– Acceptance

“By submitting this application, the Hospital confirms that the authorized representative has read, understood and accepts the above terms and responsibilities on behalf of the Hospital, and that the Hospital will comply with all applicable laws and regulations in relation to participation in this Program.”