QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 163, S. 2004)
The Order cites Executive Order No. 5 (s. 1986) and Administrative Order No. 33-A (s. 1994) as the mandate for DOH to license and regulate dialysis clinics, which is then amended/revised by this issuance.
It applies to all government and private dialysis clinics nationwide—both free-standing and institution-based—and sets technical standards/requirements and procedural guidelines leading to licensure.
Ownership: (1) Government and (2) Private. Institutional character: (1) Institution-based (part of a health institution located within its premises) and (2) Free-standing (operates independently, may be inside or outside a health institution).
A Board Certified Nephrologist must be the head. If unavailable, a Board Qualified/Eligible physician certified by the Philippine Society of Nephrology may head for a maximum of three (3) years; thereafter, a Board Certified Nephrologist must head the clinic.
They must be members of at least a secondary care hospital medical staff in the locality to facilitate referral of complications arising from dialysis.
Duty Physician must have completed an accredited Internal Medicine Residency Program, have experience in care of end-stage renal disease patients, and have training certificates on Basic and Advanced Life Support; physically available during hours of operation; ratio of duty physician to patient bed is 1:15.
Nurses must be duly licensed, current members of ReNAP (or equivalent), certified IV therapy nurses, with at least one (1) year hospital/clinical experience, plus special training on dialysis for not less than 30 days and Basic and Advanced Life Support; nurse-to-patient bed ratio is 1:4.
The technician must have a certificate of dialysis training and at least one (1) year experience in the same field.
Among others: dialysis stations must provide adequate space and privacy and be at least 8 square meters to accommodate a chair/bed, dialysis equipment, and emergency equipment if needed; separate machines designated solely for Hepatitis B and Hepatitis C patients; nursing station with adequate surveillance/releasing area for post-hemodialysis patients; storage for sterile instruments/supplies; work counter/handwashing sink/cabinets; staff/patient toilet facilities; water treatment area; central sterilization; and pre-treatment/consultation areas.
Water supply must be adequate in volume/pressure. Dialysis water must be analyzed for bacteria at least monthly and for chemicals at least every six months, and treated as necessary per AAMI standards to ensure continuous water supply biologically and chemically compatible with acceptable dialysis techniques.
All plumbing must be installed to prevent backflow or cross-contamination between potable and non-potable water supplies.
The Order requires adequate equipment such as stethoscopes, sphygmomanometers, examining light, oxygen unit, dialysis machines (at least one using bicarbonate as dialysate buffer), dialysis chairs/beds with safety features, ECG machine, suction machine, defibrillator with monitor, stretcher, wheel chair, standby generator (at least 20 KVA), and fire extinguisher; plus an ambulance/transport or contract; and an emergency cart with IV fluids/lines, intubation set, and specified emergency drugs.
They must maintain a record system with readily available information on: patient care (dialysis charts, standing orders, consent forms, monitoring sheets, laboratory results, referral/transfer slips), incident/accident logbooks (complications, outcomes, hepatitis status), vaccination records, water treatment records, administrative minutes/reports, and facility/equipment maintenance schedules.
Clinics must register patients to the Renal Disease Registry supporting DOH’s REDCOP, in coordination with the Philippine Society of Nephrology, and submit an annual statistical report to REDCOP.
No. For hospital-based clinics, compliance with technical requirements is determined during the survey for the hospital license; thus, there is no need for a separate clinic license to operate.
The License to Operate has a two-year validity from issuance. If the clinic does not apply for renewal within thirty (30) calendar days after expiration, it must stop its operation and apply for a new license.
Operating without a valid DOH license may result in fines from not less than Php 10,000 to not more than Php 50,000. All such clinics are to be immediately closed. Additionally, DOH may suspend or revoke licenses for violations.
Aggrieved clinics/personnel may file a notice of appeal within ten (10) days from receipt of the Bureau Director’s notice of decision. The Office of the Secretary’s decision is final and executory.