Law Summary
Scope
- Applies to all government and private dialysis clinics nationwide.
- Covers both free-standing and institution-based clinics.
- Establishes technical standards and procedural guidelines for licensure.
Definition of Terms
- Bureau: Bureau of Health Facilities and Services.
- Board Certified Nephrologist: Diplomate/fellow of Philippine Society of Nephrology.
- Board Qualified Physician: Physician trained in nephrology but not certified.
- Dialysis: Treatment by diffusion (hemodialysis or peritoneal dialysis).
- Dialysis Station: Designated treatment area within a clinic.
- Dialysis Clinic: Facility providing outpatient dialysis.
- Dialysis Technician: Assists in dialysis under supervision.
- License to Operate: DOH authorization to run a clinic.
- Patient: Person receiving dialysis care.
- Permit to Construct: Required before building or modifying a clinic.
- Water Treatment: Process ensuring water meets AAMI standards for dialysis.
- Secondary Care Hospital: Hospital providing clinical and surgical care.
Policies and Guidelines - Classification
- Ownership: Government or Private.
- Institutional Character: Institution-based (part of hospital) or Free-standing (independent).
Personnel Requirements
- Headed by Board Certified Nephrologist or board-qualified physician for max 3 years.
- Duty Physician with residency in Internal Medicine, experience with renal disease, and life support training; 1:15 ratio.
- Dialysis Nurses require licensure, ReNAP membership, IV therapy certification, special dialysis and life support training; 1:4 ratio.
- Technicians with dialysis training and 1 year experience.
- Adequate administrative staff.
- Maintenance of personnel records including examinations and job descriptions.
Physical Plant Requirements
- Facility layout must be planned by licensed engineer/architect.
- Dialysis station minimum 8 sq meters; separate machine for Hepatitis B and C patients.
- Nursing station for patient surveillance.
- Storage, work, toilet, water treatment, central sterilization, pre-treatment, consultation areas.
- Non-treatment areas include business office, waiting area, pantry.
- Adequate water supply meeting AAMI standards; plumbing prevents contamination.
- Proper ventilation and lighting.
Equipment and Supplies
- Specific minimum equipment list including stethoscopes, sphygmomanometers, oxygen units, dialysis machines, emergency carts, sterilizer, ECG, suction machine, defibrillator, stretcher, wheel chair, generator, fire extinguisher, ambulance arrangements.
- Water treatment equipment specified.
Transfer Agreement and Referrals
- Memorandum of Agreement with secondary care hospitals for emergency care and services.
- Patient choice of hospital respected.
Records
- Comprehensive patient care records including dialysis charts, orders, consent, monitoring, lab results, history.
- Incident logs documenting complications and dialysis adequacy.
- Staff and patient vaccinations tracked.
- Water treatment testing records.
- Administrative meeting minutes and inspection reports.
- Equipment maintenance schedules.
Recording and Reporting
- Registration of patients with Renal Disease Registry.
- Annual statistical reporting to REDCOP.
Policies and Procedures Manual
- Clinics must have written policies to ensure safe, professional care.
Quality Assurance Program
- Continuous quality evaluation with written plans and periodic reviews.
Waste Management Program
- Written program for proper handling and disposal of infectious/pathological wastes.
- Compliance to Health Care Waste Management Manual.
Exhibition of License
- License to Operate must be displayed visibly.
- Rules and regulations accessible for staff reference.
Procedural Guidelines - Permits and Licenses
- All clinics must secure licenses from DOH, except hospital-based clinics licensed with hospital license.
- Permit to Construct required before license.
- Application process involves submission of forms, letters, floor plans, and fees.
- Bureau reviews and issues or disapproves permits and licenses.
- Deficient applications given 15 days to correct or must reapply with fees.
Payment of Fees
- Non-refundable fees for permits and licenses.
- Surcharge for late renewals within 30 days after expiry.
- Payment to DOH cashier with prescribed schedule.
Monitoring
- Unannounced inspections to ensure compliance.
License Validity
- Two-year validity from issuance.
Terms and Conditions
- License is non-transferable.
- Separate license required for branches/extensions.
- Prior written notice required for name changes and dialysis station additions.
- Change of ownership or location requires new license.
Penalties
- Suspension or revocation for violations after investigation.
- Operating without license fined Php 10,000 to Php 50,000.
Investigation of Charges and Complaints
- Bureau may investigate complaints and monitor.
- Preventive suspension up to 60 days possible.
- Unlicensed clinics immediately closed.
Appeal Process
- Appeals to Office of Secretary of Health within 10 days.
- Bureau forwards documents for final review.
- Secretary’s decision is final.
Implementing Mechanisms
- Bureau regulates licensing and enforcement.
- Centers for Health Development report illegal operations.
- PhilHealth accredits clinics and monitors performance.
- Coordination among agencies encouraged.
Moratorium
- Existing clinics have one year from promulgation to comply and apply for licenses.
- Clinics failing to apply will be closed immediately.
Separability and Repealing Clause
- Invalid provisions do not affect the rest of the rules.
- These regulations supersede inconsistencies in previous orders.
Effectivity
- Effectivity upon signing and 15 days after publication in a general newspaper.