DOH AO Institutionalizing Renal Disease Registry

Purpose and policy direction

The Order institutionalizes and strengthens the Philippine Renal Disease Registry (PRDR) under the National Epidemiology Center (NEC) of the Department of Health (DOH).
The Order formalizes the involvement of the National Kidney and Transplant Institute (NKTI) through its Renal Disease Control Program (REDCOP) as the implementing arm of the PRDR.
The PRDR is guided by principles consistent with the DOH’s technical leadership role and aimed at achievement of the National Objectives for Health (NOH) and the Millennium Development Goals (MDG).
The PRDR’s data must be useful and applicable for health planning and policy formulation and must follow simplicity with flexibility for integration into other disease registries.
The PRDR recognizes and adopts partnership and shared responsibility.
The PRDR must maintain privacy and confidentiality of patient information.
The Department is the owner of the PRDR data, and it makes the PRDR data/information available and accessible through REDCOP based on set guidelines and protocols.
The PRDR promotes continual sustainability and support as the scope of registry use becomes more relevant to national and local health and non-health sectors.

Key definitions used

Partnership is a voluntary agreement between two or more parties to work cooperatively and objectively toward set outcomes that can be shared for effective and efficient disease surveillance, including the public and private sectors, national and local government units, external and development agencies, and other stakeholders.
Privacy is the patient’s right to choose what information to release about themselves and to whom it will be released.
Confidentiality is the obligation of public health workers to keep information about individuals restricted only to persons who absolutely need it for community health, with the patient’s right to know why information is provided, to refuse to provide it, and to expect confidential handling.
Dialysis is a process removing dissolved substances from a patient’s body by diffusion from one fluid compartment to another across a semi-permeable membrane, with common types being hemodialysis and peritoneal dialysis.
Patient is a person admitted to and receiving care in the dialysis clinic and hospital.
Government hospital is a hospital operated and maintained partially or wholly by the national, provincial, city, municipal government, or other political unit, or any department, division, board, or agency thereof.
Private hospital is a hospital privately owned, established and operated with funds through donation, principal, investment, or other means by an individual, corporation, association, or organization.
Institution or hospital based clinic is a clinic operating as part of a health institution and located within its premises.
Free-standing clinic is a clinic/unit/center operating independently and located outside or inside the premises of a health institution.
Training Institution is a hospital or medical facility that provides sub-specialty training for nephrology and transplantation.

Scope, coverage, and participating entities

The PRDR implementation covers collection and retrieval of data of ESRD patients from all dialysis units, transplant centers, and other hospital facilities engaged in management and treatment of kidney patients, especially those with chronic kidney diseases and ESRD patients, nationwide.
The participating health facilities include hemodialysis centers (free-standing and hospital-based), peritoneal dialysis units, transplant centers, and other hospital facilities with renal biopsy capability.
The participating health professionals include nephrologists, transplant surgeons, pathologists, internists, residents and fellows in nephrology and transplantation, nurses, and medical technologists, among others.
Dialysis clinics/centers/units serve as sources of dialysis patient data forms for PRDR.
Hospital facilities including training institutions cater to renal work-up and treatment, including renal biopsy and transplantation operations, within the PRDR coverage.
Centers for Health Development (CHD) participate through officially assigned REDCOP coordinators who collect/retrieve dialysis patient data forms from dialysis centers/clinics/units and collate them for submission to REDCOP.
The Philippine Society of Nephrology (PSN) provides technical/specialty assistance in preparing the annual PRDR report.
The Philippine Health Insurance Corporation (PHIC) enforces participation of all accredited dialysis clinics (hospital-based or free-standing) pursuant to Circular No. 06 s. 2006 (Annex A).

Registry scope and operational standards

The PRDR includes an ESRD Registry consisting of data of patients on hemodialysis, peritoneal dialysis, and patients who underwent transplant operations.
The PRDR also includes a Chronic Renal Disease Registry consisting of data of patients with renal biopsy.
The scope of the PRDR expands as the need arises for the interest of the public and the health sector.
Detailed implementing guidelines are reflected in the Manual of Procedures of the PRDR 2006 (Annex B).
Monitoring and assessment of implementation and data management are carried out through defined supervisory structures under REDCOP and NEC.

Roles, responsibilities, and implementation mechanics

The National Epidemiology Center (NEC) provides overall supervision and allocates annual funds and logistic support to REDCOP–NKTI for overall management and implementation of the PRDR.
NEC ensures PRDR results are utilized for national health planning and policy formulation and that registry results are analyzed, utilized, and disseminated by officially designated NEC personnel.
NEC gives official designation/authority to NKTI–REDCOP to coordinate with CHDs activities pertaining to training/orientation, data gathering, verification, and consolidation of reports from dialysis units, transplant centers (through officially designated transplant coordinators), and hospitals (for the kidney biopsy registry through the attending physician).
NEC requires REDCOP–NKTI to submit reports to NEC–DOH on a semi-annual basis or as needed.
NEC ensures effective implementation by making all lines of communication accessible to the implementing arm.
NEC monitors and evaluates PRDR implementation and data management.
NEC creates and chairs an adhoc working committee and calls quarterly meetings for updates, feedback, and resolution of issues; the committee receives and studies expert advice from official representatives of concerned agencies and other stakeholders for appropriate action, decision, recommendation.
NEC spearheads the appraisal of research proposals and projects on Renal Disease Management, Prevention and Control.
NEC designates an official point person for PRDR.
NKTI–REDCOP maintains privacy and confidentiality of patients’ information.
NKTI–REDCOP designates/hires technical people to assist in report preparation and performs overall management and implementation of the PRDR as mandated by NEC–DOH.
NKTI–REDCOP provides technical support and direction on the proper reporting form for PRDR data.
NKTI–REDCOP submits to DOH semi-annual reports to NEC or as needed.
NKTI–REDCOP submits biannual accomplishment and audited financial reports to DOH finance service and furnishes NEC with copies.
NKTI–REDCOP submits DOH reports in publishable form annually, in addition to the annual PRDR report.
NKTI–REDCOP liaises with other agencies, GOs, and NGOs as necessary to improve PRDR operations and data quality.
NKTI–REDCOP attends quarterly NEC meetings or as necessary.
The Bureau of Health Facilities and Services (BHFS) enforces the registry of patients of all dialysis units through REDCOP pursuant to Administrative Order (AO) No. 163, s. 2004, Revised Rules and Regulations Governing Registration, Licensure and Operation of Dialysis Clinics in the Philippines.
CHD coordinators collect/retrieve the data forms of dialysis patients and collate them for submission to REDCOP.

Budgeting, reporting, and monitoring timelines

The DOH releases funds for PRDR yearly operations based on the budget proposed by NKTI–REDCOP and approved by NEC.
The annual fund supports PRDR operations, including transportation and communication expenses, supplies and materials, payment of salaries of contractual personnel, and honorarium for consultants, plus overall PRDR operations at the regional level.
The fund is charged to the National Epidemiology Center under GOP Fund Source A. III.b.I.
Any approved expansion of the scope of the registry receives corresponding budget allocation from the DOH.
REDCOP submits an annual report to DOH–NEC every first quarter of each succeeding year.
REDCOP provides quarterly updates on the status of implementation and budget utilization to NEC during the first month of the ensuing quarter of each year.
Monitoring details are handled by REDCOP headed by the program manager, while NEC headed by the Director conducts semi-annual supervisory assessment for DOH.
Administrative and financial problems, issues, and concerns arising from PRDR implementation are brought to the NEC Director and the officially designated coordinator for discussion and appropriate action.

Confidentiality, privacy, and patient rights

The PRDR ensures that privacy and confidentiality of patient information will be maintained.
The PRDR defines Privacy as the patient’s right to choose information release and the recipient of that information.
The PRDR defines Confidentiality as restricting information to persons who absolutely need it for community health and includes the patient rights to know why information is provided, to refuse to provide information, and to expect confidential handling.
NKTI–REDCOP maintains privacy and confidentiality of patients’ information as part of its implementing functions.

Repeal clause and governing effectivity

Any existing order inconsistent with any PRDR provisions is repealed or superseded by the Order.
The Order takes effect upon approval and 15 days after publication in the official gazette or a newspaper of general circulation.