Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 163, S. 2004)
The primary purpose is to set revised rules and regulations governing the registration, licensure, and operation of dialysis clinics in the Philippines to ensure quality health services for patients undergoing dialysis.
These rules apply to all government and private, freestanding and institution-based dialysis clinics nationwide in the Philippines.
A dialysis clinic is defined as a health facility performing both peritoneal and/or hemodialysis to patients with kidney failure on an outpatient basis.
Dialysis clinics are classified by ownership as government or private and by institutional character as institution-based or free-standing clinics.
The head must be a Board Certified Nephrologist; however, in areas without one, a board-qualified physician may head the clinic for a maximum of three years, after which a Board Certified Nephrologist must assume the role.
Any clinic operating without a license shall be fined not less than Php 10,000 and not more than Php 50,000 and may be subject to closure.
Applicants must first secure a Permit to Construct by submitting required documents and plans for approval before they can apply for a License to Operate.
The License to Operate has a validity period of two years from the date of issuance.
A clinic must employ a Board Certified Nephrologist or board-qualified physician, duty physicians trained in internal medicine and end stage renal disease care, licensed dialysis nurses with special training, dialysis technicians, and adequate administrative personnel.
No, the license is not transferable and separate licenses are required for extensions or branches.
It ensures that dialysis clinics have arrangements with hospitals capable of providing inpatient care and emergency services for referral cases.
Clinics must maintain records of patient care, incidents and accidents, vaccination status, water treatment, administrative reports, and equipment/facility maintenance schedules.
Water used must be treated to meet the Association for the Advancement of Medical Instrumentation (AAMI) standards and monitored regularly for bacteria and chemicals.
The clinic must cease operation and apply for a new license, paying the required fees anew.
The Bureau may investigate complaints, conduct monitoring visits, issue preventive suspension up to 60 days, or revoke the license if violations are found.
It may file a notice of appeal within ten days from receipt of the decision to the Office of the Secretary of Health, whose decision is final and executory.
The ratio is 1 duty physician for every 15 patient beds and 1 nurse for every 4 patient beds.
Existing clinics have one year from the promulgation date to comply with the revised rules and must apply for a license during that period or face closure.
Clinics must have dialysis machines (at least one using bicarbonate dialysate), oxygen unit, emergency drugs, defibrillator, water treatment equipment, and standby generator, among others.