Title
Regulation of Dialysis Clinics in the Philippines 2004
Law
Doh Administrative Order No. 163, S. 2004
Decision Date
Jun 14, 2004
A Philippine Jurisprudence case highlights the purpose, scope, requirements, and consequences of DOH Administrative Order No. 2004-0163, which establishes rules and regulations for the registration, licensure, and operation of dialysis clinics in the country to ensure the provision of quality health services to patients.
dialysis clinics
registration
licensure

Legal basis and mandate to license

  • The DOH rules are grounded on Executive Order No. 5, s. 1986, which mandates DOH regulation through its health regulatory functions.
  • The DOH mandate is also tied to Administrative Order No. 33-A, s. 1994, which previously governed licensure and regulation of dialysis clinics.
  • These revised rules amend A.O. No. 33-A, s. 1994 to strengthen compliance and licensing for dialysis clinics.

Policy, purpose, and coverage rationale

  • The rules require dialysis clinics to comply with DOH licensing requirements to ensure patients receive quality health service.
  • The rules establish technical standards and operational requirements that dialysis clinics must meet to obtain DOH licensure.
  • The rules aim to guide facility owners on new licensing requirements and to improve regulatory compliance where many centers previously operated without licenses.

Core definitions used in regulation

  • “Bureau” refers to the Bureau of Health Facilities and Services.
  • “Board Certified Nephrologist” refers to a diplomate or fellow of the Philippine Society of Nephrology.
  • “Board Qualified/Eligible Physician” refers to a physician who is a fellow/diplomate of the Philippine College of Physicians and has completed an accredited fellowship-training program in nephrology.
  • “Dialysis” is the process by which dissolved substances are removed from a patient’s body by diffusion across a semi-permeable membrane; the commonly used types are hemodialysis and peritoneal dialysis.
  • “Dialysis Station” is a designated portion of the dialysis patient treatment area that accommodates equipment needed for hemodialysis and/or peritoneal dialysis, including sufficient space for a chair or bed, equipment, and emergency equipment when needed.
  • “Dialysis Clinic” is a health facility performing both peritoneal and/or hemodialysis to patients with kidney failure on an outpatient basis; it is referred to as “Clinic.”
  • “Dialysis Technician” is a person who, under the direct supervision of a licensed physician or a registered nurse, provides assistance during dialysis treatment for end stage renal disease.
  • “License to Operate” is the formal authority issued by the DOH to an individual, agency, partnership, or corporation to operate a dialysis clinic.
  • “Permit to Construct” is the requirement for construction, alteration, expansion, or renovation of an existing dialysis clinic and is a pre-requisite for the issuance of a license to operate.
  • “Secondary Care Hospital” is defined by Administrative Order No. 147, s. 2004 as a departmentalized hospital providing clinical care and management on prevalent diseases in the locality, including particular forms of treatment, surgical procedures, and intensive care.
  • “Patient” is a person admitted to and receiving care in the dialysis clinic.
  • “Water Treatment” is the treatment of water used for dialysis to maintain a continuous water supply meeting AAMI “Standards for Water for Hemodialysis.”

Classification, facility standards, and operational rules

  • Dialysis clinics are classified according to ownership as:
    • Government clinics, operated and maintained partially or wholly by national, provincial, city, or municipal governments or other political units or by their departments, divisions, boards, or agencies; and
    • Private clinics, privately owned and established and operated with funds through donation, principal, investment, or other means by individuals, corporations, associations, or organizations.
  • Dialysis clinics are classified according to institutional character as:
    • Institution-based clinics operating as part of a health institution (e.g., hospital, multi-specialty clinic) and located within its premises; and
    • Free-standing clinics operating independently, located outside or inside health institution premises.
  • The clinic must have sufficient qualified personnel, including a clinic head and other required staffing, and must maintain employee records in a personnel record folder containing physical examination, laboratory results, resume, and current job description reflecting responsibilities and work assignments.
  • The facility must meet technical requirements for physical plant, ventilation, illumination, plumbing protections against backflow/cross-contamination, adequate water supply with required bacterial and chemical analyses, equipment and supplies, records, reporting, policies/procedures, quality assurance, and waste management.
  • The clinic must maintain required documentation and operational systems, including patient care records, incident/accident logs, vaccination tracking, water treatment records, administrative records, and preventive maintenance and maintenance schedules.

Required staffing ratios and qualifications

  • The clinic head must be a Board Certified Nephrologist; where none exists in the area, a board-qualified physician may head the clinic for a maximum period of three (3) years, after which a Board Certified Nephrologist must head the clinic.
  • The clinic head or at least one medical staff must be a member of at least a secondary care hospital medical staff in the locality to facilitate referral of dialysis complications.
  • A Duty Physician must:
    • complete an accredited Internal Medicine Residency Program;
    • have experience in care of patients with end stage renal disease; and
    • hold training certificates on Basic and Advanced Life Support.
  • The Duty Physician must be physically available to patients during hours of operation, with a required ratio of duty physician to patient bed of 1:15.
  • A Dialysis Nurse must be:
    • duly licensed;
    • a current member of the Renal Nursing Association of the Philippines (ReNAP) or its equivalent;
    • a certified IV therapy nurse;
    • have hospital/clinical work experience for one (1) year; and
    • have certificates of special training on dialysis for not less than thirty (30) days and on Basic and Advanced Life Support.
  • The required ratio of nurse to patient bed is 1:4; if more than one (1) nurse is present, headship shall be by a chief nurse, with qualifications based on Republic Act No. 9173, the Philippine Nursing Act of 1992.
  • A Technician must have a certificate of dialysis training and at least one (1) year experience in the same field.
  • The clinic must maintain an adequate number of administrative personnel to facilitate non-medical work in the facility.

Physical plant, water, and equipment requirements

  • The clinic must be planned and designed with required areas and facilities, and the clinic plan must be prepared and signed by a licensed engineer or architect and conform to applicable laws.
  • The plan must include a Dialysis Service Complex with:
    • a Dialysis Station area not less than 8 meter² to accommodate a chair or bed, dialysis equipment, and emergency equipment if needed;
    • a separate dialysis machine designated solely for Hepatitis B and C patients;
    • a Nursing Station allowing adequate surveillance and functioning as the releasing area for post-hemodialysis patients;
    • a storage area for sterile instruments/supplies and other materials;
    • a work area with a work counter, hand washing sink, and storage cabinets;
    • toilet facilities for staff/patients including urinal, water closet, and lavatory;
    • a Water treatment area; and
    • a designated area for central sterilization, plus pre-treatment and consultation areas.
  • The plan must include a Non-Treatment Area with business information services (including admitting section and cashier), a waiting area with sufficient seats for patients and visitors, and a pantry for hygienic purposes.
  • The facility must be kept in good operating condition, with water supply adequate in volume and pressure.
  • Water used for dialysis purposes must be analyzed for bacteria at least monthly, for chemicals at least every six months, and must be treated as necessary in accordance with AAMI standards to maintain continuous water supply compatible with acceptable dialysis techniques.
  • Plumbing must be installed to prevent backflow or cross-contamination between potable and non-potable water supplies.
  • The clinic must provide effective ventilation to maintain comfortable room temperature.
  • The clinic must provide sufficient intensity of illumination for effective nursing care.
  • The clinic must have required equipment and supplies, including at least:
    • Stethoscope – 3 units;
    • Sphygmomanometer – 3 units, with one each for regular, Hepatitis B+, and Hepatitis C+ patients;
    • examining light; oxygen unit with gauge; minor surgical instrument set; instrument table;
    • dialysis machine(s), with at least one using bicarbonate as dialysate buffer;
    • dialysis chair(s) (capable of full recline and trendelenberg position) or patient bed(s) with guard rails (90cm x 70 cm) or its equivalent;
    • an E-cart with IV fluids and IV line supplies (including Insyte/abbocath), an intubation set (endotracheal tubes, laryngoscope, ambu bag), emergency drugs (including listed drugs such as dopamine IV infusion, isosorbide dinitrate tablets, diazepam tablets and IV, hydrocortisone IV, diphenhydramine maleate 50 mg/amp, sodium chloride 20% in 50 cc polyampule, D50W 50cc vial, and listed others), goose neck lamp, and standby rechargeable light;
    • sterilizer; ECG machine; suction machine; defibrillator with cardiac monitor; stretcher; wheel chair; and others;
    • a standby generator of at least 20 kva;
    • fire extinguisher; ambulance or transport vehicle or contract with ambulance providers;
    • water treatment equipment including multi-media filter, bulk filters, carbon filter, softener, reverse osmosis machine, storage tank for reverse osmosis, acceptable disinfectant for re-use procedure, Formalin (4%), and Paracetic Acid (hydrogen peroxide + acetic acid).

Transfers/referrals, records, and data reporting

  • The clinic must maintain a Memorandum of Agreement with one or more hospitals with service capability of at least a secondary care hospital for inpatient care during emergencies and other hospital services.
  • Patients or their relatives must be allowed to choose which hospital to patronize.
  • The clinic must maintain a record system providing readily available information on:
    • Patient care, including dialysis charts; standing order for hemodialysis updated quarterly; physician’s orders; completed consent form updated annually; patient monitoring sheet; standing order for medication; laboratory results; confinements with date and hospital name; history and physical examination; problem list; and transfer/referral slip.
    • Incident and accident logs covering complications related to dialysis procedure, vascular access, disease process, dialysis adequacy, outcomes, and staff/patient hepatitis status.
    • Staff and patient vaccination including hepatitis B (double dose) at months 0, 1, 2, 6; influenza annually; and pneumococcal every 5 years.
    • Water treatment bacteriological and chemical records.
    • Administrative materials including minutes of staff meetings and reports of inspections.
    • Facility and equipment maintenance schedule including preventive maintenance and corrective measures.
  • The clinic must register patients to the Renal Disease Registry supporting DOH REDCOP, in coordination with the Philippine Society of Nephrology.
  • The clinic must submit an annual statistical report to REDCOP.
  • The clinic must provide a policy and procedure manual designed to ensure professional and safe care.
  • The clinic must implement a quality assurance program with a written plan, continuous implementation, and periodic reviews.
  • The clinic must implement a written and established waste management program with special treatment on infectious/pathological waste, following the revised Manual on Health Care Waste Management.

Display of license and unannounced monitoring

  • The clinic must post its license to operate in a conspicuous space readily seen by the public.
  • A copy of the rules and regulations must be readily available for reference and guidance of clinic staff and personnel.
  • All clinics must be monitored unannounced, and records must be made available to determine compliance with the rules.

Permit to construct and license application process

  • Every clinic must secure a license to operate from the DOH.
  • For hospital-based clinics, compliance with prescribed technical requirements is determined during the survey for the hospital license, so a separate clinic license is not required.
  • Permit to Construct (pre-requisite for License to Operate):
    • Applicants request relevant information and prescribed forms from the Bureau in person or through mail, email, or internet.
    • Applicants must submit the following to the Bureau:
      • BHFS Form: Application for Permit to Construct, duly notarized;
      • a letter of application to the Director of the Bureau;
      • a letter of endorsement to the Director of the Bureau if the application is submitted to the CHD;
      • four sets of floor plans/layout (excluding plumbing, electrical, etc. layouts).
    • Upon filing, applicants must pay the corresponding fees to the DOH Cashier in cash or through postal money order.
    • The Bureau reviews the documents and approves or disapproves issuance of the permit to construct.
    • If disapproved, the Bureau sends findings and recommendations for compliance; after receipt, the applicant has a maximum of fifteen (15) calendar days to revise and resubmit for another review.
    • Failure to revise within the timeframe requires payment again of the corresponding application fee.
  • Application for License to Operate:
    • Applicants request relevant information and prescribed forms from the Bureau in person or through mail, e-mail, fax transmittal (781-4189), or internet (doh.gov.ph).
    • Applicants must accomplish and submit documentary requirements and pay the corresponding fees to the DOH Cashier in cash or through postal money order.
    • Documentary requirements include:
      • Form No. 1-01: Application for Registration and Issuance of License to Operate;
      • Form No. 2-01: Application for Renewal of License to Operate;
      • a list of personnel with certified true copies of proof of qualifications (professional licenses, diplomate/fellowship certificates, training certificates, etc.);
      • a list of equipment/instruments with proof of purchase;
      • a copy of the clinic’s Manual of Standard Operating Procedures (administrative and technical);
      • a yearly summary report of patients registered to the Renal Disease Registry (Certificate of Compliance);
      • other documents that may be required by the Bureau.
    • The Bureau conducts an on-site survey to determine compliance with standards and technical requirements.
    • The Bureau approves or disapproves issuance of the LTO.
    • If approved, the Bureau registers the clinic and issues the LTO.
    • If disapproved, the Bureau sends findings and recommendations for compliance; after receipt, the applicant has a maximum of fifteen (15) calendar days to address deficiencies.
    • Failure to comply is a ground for denial, requiring the applicant to re-apply and pay again the required licensing fee.
    • If a clinic does not apply for renewal within thirty (30) calendar days after expiration, it must stop operation and apply for a new license.

Fees, validity, and licensing terms

  • Fees are charged as non-refundable amounts for:
    • issuance of Permit to Construct,
    • registration,
    • License to Operate (initial or renewal), and
    • re-filing.
  • A surcharge is collected in addition to the renewal fee if the renewal application is filed within thirty (30) days after the expiry date of the license.
  • All fees must be paid to the Cashier Office of the DOH.
  • All fees must follow the DOH’s current prescribed schedule of fees.
  • The License to Operate has a validity period of two (2) years from the date of issuance.
  • The license to operate is not transferable.
  • A separate license is required for extensions or branches.
  • The clinic must report in writing to the Bureau any of the following changes fifteen (15) calendar days prior to the change, and the Bureau shall acknowledge receipt:
    • change of name;
    • addition of dialysis stations.
  • For change of ownership or location, the facility is considered new, and the owner must apply for a new license to operate.

Moratorium and transitional compliance

  • Clinics operating at the time of promulgation are given a period of one (1) year from promulgation to comply with these rules.
  • During that period, all existing clinics must apply for a license with the Bureau.
  • Clinics without proper application must be immediately closed.

Enforcement, penalties, complaints, and appeal

  • The Bureau may suspend or revoke a clinic’s license to operate if investigation finds violations of these rules or any law or rule related to dialysis clinic operation.
  • A clinic operating without a DOH license is fined not less than PHP 10,000.00 but not more than PHP 50,000.00.
  • The Bureau investigates complaints or charges against an accredited clinic, either on its own initiative or upon receipt of complaints/charges by any person or interested party.
  • If monitoring or fact-finding shows violations, the Bureau may preventively suspend operation for no more than sixty (60) days.
  • Clinics operating without a valid license must be immediately closed.
  • Appeals:
    • A clinic or any of its personnel aggrieved by the Director of the Bureau’s decision may file a notice of appeal with the Office of the Secretary of Health within ten (10) days from receipt of the decision notice, and must furnish the Bureau a copy.
    • The Bureau must certify and file the decision copy, including the transcript of hearings, with the Office of the Secretary for review.
    • The Office of the Secretary’s decision is final and executory.

Implementation mechanism and coordinating agencies

  • The Bureau of Health Facilities and Services regulates kidney dialysis facilities and is primarily responsible for issuance, suspension, or revocation of the license to operate.
  • Centers for Health Development must report to the Bureau information regarding illegal operation of clinics in their respective areas.
  • PhilHealth must support regulation by:
    • accrediting health facilities and providers meeting accreditation requirements under the National Health Insurance Act of 1995 and related PhilHealth reimbursement guidelines and directives; and
    • conducting utilization reviews and performance monitoring to support accreditation standards and institutionalize best quality clinical and medical practices in kidney dialysis service.
  • The Bureau and PhilHealth must regularly coordinate and synchronize efforts to regulate health and health-related facilities involved in kidney dialysis service.

Separability, repeals, and supersession

  • If any rule, section, paragraph, sentence, clause, or words are declared invalid for any reason, the remaining provisions continue in force.
  • The rules and regulations repeal and supersede administrative orders and previous issuances that are inconsistent with these rules and regulations.

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