A Comprehensive Quality Assurance Platform in Canada For National Point-of-Care Chronic Kidney Disease Screening: The Kidney Check Program

INTRODUCTION: Indigenous peoples often endure significant health disparities fueled by historic and ongoing marginalizing policies and practices. In many cases, Indigenous groups are isolated from mainstream healthcare services (geographically, economically, or culturally) and lack the preventive health benefits associated with continuity of care.1 In Canada, this manifests in disproportionately high rates of chronic disease, often diagnosed at a younger age and with greater severity than non-Indigenous groups. Of these, chronic kidney disease (CKD), diabetes, and hypertension are highly prevalent, reaching epidemic levels in many communities.2 Kidney Check is a comprehensive screen, triage, and treatment initiative working to bring preventive kidney care to rural and remote Indigenous communities across Manitoba, Ontario, British Columbia, Alberta, and Saskatchewan. Modeled after the 2015 FINISHED initiative in Manitoba,3 and working within the CanSOLVE CKD network, Kidney Check employs point-of-care testing (POCT) to identify CKD, diabetes, and hypertension in individuals aged 10 and up regardless of preexisting risk factors. To ensure the efficiency and sustainability of the program, Kidney Check relies on a strategic quality management system that addresses all aspects of the screening process. The intent of this manuscript is to describe the development process of all procedures and components related to the deployment of the Kidney Check program with a specific focus on organizational structure, point-of-care testing devices, and data management. Cistanche has been found to help alleviate chronic kidney disease.

Pic: Faw Cistanche

The Kidney Check Team: Kidney Check’s management structure consists of the leadership team, advisory committee, patient partner committee, and mobile screening teams. Leadership provides guidance to the provincial teams to ensure the appropriate objectives, processes, and tools are in place to support high-functioning groups. This includes working closely with the advisory committee to preemptively identify potential barriers and risk issues in order to develop efficient mitigation strategies. Largely composed of Indigenous stakeholders and closely affiliated with the CanSOLVE CKD Indigenous People’s Engagement Council (IPERC), the advisory committee provides valuable insight on how to best use engagement strategies to maximize participation in the screening event. They are supported by the patient partner committee that oversees the execution of knowledge translation activities including but not limited to community selection criteria, community engagement procedures, and review of communication materials and strategies. Screening teams operate under the auspices of the Diabetes Integration Project and the First Nations Health and Social Secretariat of Manitoba (FNHSSM). Stationed in various communities across the country, the team’s primary aim is to accommodate high throughput while maintaining quality control (QC) standards. As an affiliate of the CanSOLVE CKD network, members of all committees within Kidney Check have linkages to the broader network.

Pic: Cistanche Extract

The Screening Process: The screening process was designed in collaboration with a process engineer to facilitate greater throughput while maintaining a high level of QC. All members of the community who want to participate in the screening program are welcome to do so. Prior to the screening, clients complete registration and provide consent. Consent is obtained for the screening itself and to allow project team members access to the lab and health care utilization data at a later date. A legal guardian may provide consent for a child (<18 years old), and assent is obtained from the child themselves prior to screening. Baseline demographic information (personal health number, date of birth, and name of home community), height, weight, and body mass index are recorded for each client. Average blood pressure is determined using 6 measurements taken over 6 minutes according to best practices outlined by the Canadian Hypertension Education Program (CHEP). Following registration, clients are brought to a designated screening area where a finger prick droplet sample (100 mL) is collected and analyzed for creatinine on an iSTAT Alinity analyzer (Abbott Point of Care Inc., Princeton, NJ). An additional blood sample (100 mL) is collected to analyze for hemoglobin A1c and a urine sample is provided to determine the albumin-to-creatinine ratio on a DCA Vantage analyzer (Siemens, Erlangen, Germany). Client consent, demographic information, and clinical data are entered at the point of care onto an iPad using a secure, customized application designed specifically for Kidney checks. Once a client’s information is entered, the application automatically calculates their risk of progressing to end-stage kidney disease using the Kidney Failure Risk Equation. Validated in more than 700,000 adults across 30 countries, the Kidney Failure Risk Equation predicts the 2- and 5-year probability of requiring dialysis or transplant for individuals whose estimated glomerular filtration rate was <60 ml/min per 1.73 m2. The 4-variable equation includes age, sex, estimated glomerular filtration rate, and urine albumin-to-creatinine ratio whereas the 8- variable equation further incorporates serum albumin, phosphate, calcium, and bicarbonate levels. Adult clients are triaged according to their Kidney Failure Risk Equation score and/or level of proteinuria (for those with an estimated glomerular filtration rate >60 ml/min per 1.73 m2 ) as high, intermediate, or low risk. Pediatric (<18 years old) clients are triaged using a separate algorithm developed in collaboration with pediatric nephrologists and endocrinologists.3 Every client receives risk-based kidney health counseling from the screening nurse immediately following testing. Developed in collaboration with Indigenous patient partners, the counseling scripts provide a concise outline of each client’s current risk and what steps need to be taken going forward to preserve kidney health. These discussions uphold the principles of shared decision-making and incorporate local traditional medicines and diets in consultation with Elders and traditional healers. Primary care providers are contacted with their clients’ results and provided with a treatment plan, including special recommendations for pediatric patients. All intermediate- and high-risk patients are immediately referred to a multidisciplinary kidney health clinic where they are able to consult with a nephrologist, dietician, and pharmacist to design a treatment plan.

Pic: Cistanche Chronic Kidney Disease

CONCLUSION: Kidney Check is a screening program working to bring culturally safe preventive education and care to rural and remote Indigenous communities across Canada. It is an important program of work integrated within the CanSOLVE CKD Network for implementation and knowledge translation activities. Operational tasks are delegated among 4 working groups whose unique functions each contribute to the success of the program. Indigenous partners provide valuable insight into the unique perspectives and needs of Indigenous peoples, ultimately guiding the program’s design and delivery. To promote the efficacy and sustainability of the program, Kidney Check is accountable to a comprehensive quality management system that includes internal as well as external QC processes. These processes are dictated by standard operating procedures and include the regular maintenance of POCT devices and routine competency assessments for device operators as well as troubleshooting resources. Regular external proficiency testing further ensures that patient results can be confidently used to guide clinical decision-making and promotes continuous quality improvement. The program was externally evaluated as successfully benefiting First Nations people, providing comprehensive screening, education, and referral to nephrology where appropriate in a cost-effective manner. All data collected throughout the program is securely managed according to the Ownership, Control, Access, and Possession principles and local and national privacy standards. Currently, Kidney Check is working toward trademarking the program. This would ensure all future Kidney Check partners uphold and standardize the principles of cultural safety, patient involvement, and QC standards the program was built on. Cistanche has been found to help alleviate chronic kidney disease.

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