Rules on Licensure and Regulation of Dialysis Clinics

Legal basis, rescission, and effectivity

DOH Administrative Order No. 2012-0001 rescinds A.O. No. 163 s. 2004 and A.O. No. 2006-0037 (XIII).
Inconsistent or contrary provisions from previous issuances are repealed and modified accordingly (XIII).
If a provision or part is declared unauthorized or invalid, the remaining parts continue to be valid and in force (XIV).
Section XV fixes the effectivity rule at 15 days after approval and publication in a newspaper of general circulation.

Policy, objective, and regulatory intent

The Order requires a revised minimum standard to ensure safe and effective hemodialysis (HD) treatments in hemodialysis clinics (II).
HD must be provided only within DOH-licensed settings under the appropriate licensure system (V.A.1).
Dialysis clinics must participate in the Philippine Renal Disease Registry (PRDR) and register HD patients (V.A.3).
Dialysis clinics must establish continuing patient education and link with accredited kidney transplant centers (V.A.4–5).

Coverage and facility classification

The Order applies to all government and private HDC in the Philippines (III).
HD is permitted only in DOH licensed non-hospital based HDC and hospital based HDC under the One-Stop Shop Licensure System for hospitals (V.A.1).
If peritoneal dialysis (PD) is also performed in facilities regulated by DOH, DOH advocates PhilHealth accreditation standards and requirements on PD (V.A.2).
Dialysis facilities are classified by ownership:
- Government facilities are operated and maintained partially or wholly by the national government, a local government unit, or other political unit/agency (V.B.1.a.1).
- Private facilities are owned and operated with funds through donation, principal, investment, or other means by any individual, corporation, association, or organization (V.B.1.a.2).
Dialysis facilities are classified by institutional character:
- Hospital based operates within a hospital (V.B.1.b.1).
- Non-hospital based operates outside hospital premises or on its own (V.B.1.b.2).

Defined terms used throughout

“AAMI” refers to an organization that promotes knowledge and use of medical instrumentation and publishes standards; its recommended practices and standards are major healthcare guideline resources (IV.1).
“Adverse Event” is an injury caused by medical management that either caused death, prolonged hospitalization, or produced disability at discharge (IV.3).
“Applicant” is a natural or juridical person applying for a license to operate an HDC (IV.4).
“BHFS” is the regulatory body of DOH charged with the licensing function under these rules (IV.5).
“Board Certified Physician” is a physician who is a diplomate and/or fellow of a recognized specialty/subspecialty society and certified by the corresponding medical specialty/subspecialty board (IV.6).
“Board Eligible Physician” is a physician who completed accredited specialty/subspecialty training approved by the corresponding board (IV.7).
“CHD” is the regional office of DOH (IV.8).
“Certificate of Compliance (COC)” is issued by REDCOP upon compliance with reporting and participation in PRDR; it is a pre-requisite to renewal of LTO (IV.9).
“Dialysis Station” is a designated portion of an HDC that accommodates materials and equipment for HD, with a minimum area of at least 6 square meters capable of accommodating a dialysis chair or patient bed, a dialysis machine, and emergency equipment (IV.11).
“Dialysis” is the process of removing dissolved substances across a semi-permeable membrane using dialyzing equipment and recognized procedures (IV.10).
“Hemodialysis (HD)” is a procedure where patient blood is delivered by a machine to a dialyzer to remove wastes and restore fluid/electrolyte balance (IV.15).
“Hemodialysis Clinic (HDC)” is the list of DOH licensed HDC posted at doh.gov.ph (IV.16).
“License to Operate (LTO)” is the authority issued by DOH to operate a non-hospital based HDC (IV.17).
“One-Stop Shop (OSS)” is the DOH strategy harmonizing licensure of hospitals and ancillary facilities; under OSS, a hospital based HDC is not required to secure a separate LTO and HD provision is reflected in the hospital LTO upon full compliance with the Order (IV.18).
“Peritoneal Dialysis (PD)” uses the peritoneum as the dialysis membrane (IV.19).
“Physician On Duty (POD)” refers to the Physician On duty in an HDC (IV.20).
“PRDR” is a compilation of all dialysis patients’ data institutionalized under DOH by virtue of A.O. No. 2009-0012 (IV.23).
“REDCOP” is the Renal Disease Control Program, implemented by the National Kidney Transplant Institute (NKTI) of DOH (IV.24).
“Refurbished HD Machine” is a pre-owned HD machine reconditioned and calibrated to specifications by the supplier (IV.25).
“Reverse Osmosis (RO)” is a filtration method producing ultrafiltration by pressure across a selective membrane (IV.26).
“Water Treatment” is treating water used for HD to meet AAMI standards for water for hemodialysis (IV.27).

General and operational minimum standards

Every HDC must be organized to provide safe, quality, effective and efficient HD services (V.B.2).
Every HDC must follow this Order and other related and future DOH issuances (V.A.7).
Every HDC must participate in PRDR, and all HD patients must be registered by the facility (V.A.3).
Every HDC must have a continuing patient education program updating patients on treatment options and kidney transplant (V.A.4).
Every HDC must have linkages with DOH accredited kidney transplant centers (V.A.5).
Every HDC must follow the standards, criteria, and requirements in the assessment tool for licensure of HDC (V.A.6).

HDC personnel requirements

Every HDC must have an adequate number of qualified, trained, and competent staff; composition depends on workload and services provided (V.B.2.a).
Each HDC must have a Medical Director who is licensed by PRC and preferably is a nephrologist certified by the Specialty Board of PSN; PSN must regularly provide DOH an updated list of its board-certified members (V.B.2.a.1).
The Medical Director’s duties include overseeing technical/medical operations, ensuring procedures follow acceptable medical norms, developing and adopting internal medical protocols aligned with DOH standards coordinated with PSN, setting education and performance requirements for medical staff, requiring training programs, overseeing completion of tasks, initiating QAPI activities, ensuring strict infection control/surveillance compliance, and assuring water safety based on AAMI (V.B.2.a.1.b).
When a nephrologist is not readily available, BHFS/CHD allows physicians to handle the HDC in this priority order (V.B.2.a.1.c):
- Board eligible in nephrology;
- Board certified in Internal Medicine (IM) or Pediatrics with work experience in any DOH licensed HDC for at least 3 months;
- Board eligible in IM or Pediatrics with work experience in any DOH licensed HDC for at least 3 months;
- General practitioner with work experience in any DOH licensed HDC for at least 6 months.
Training for a non-nephrologist Medical Director must follow guidelines developed by PSN (V.B.2.a.1.c).
The Medical Director must visit the HDC at least once a week and document the visits (V.B.2.a.1.d).
The Medical Director must handle a maximum of only three (3) HDC (V.B.2.a.1.e).

Physician On Duty ratio and qualifications

Each HDC must have a POD with qualifications and duties including attending to patients under supervision of the Medical Director, being PRC-licensed and meeting specified specialty/training/work-experience qualifications, having experience in ESRD patient care, having updated ACLS training, and being present during HDC operating hours (V.B.2.a.2).
POD qualifications must include one of the following (V.B.2.a.2.a.2):
- Board certified in nephrology; or
- Board eligible in nephrology; or
- Board certified in IM or Pediatrics with work experience in any DOH licensed HDC for at least 3 months; or
- Board eligible in IM or Pediatrics with work experience in any DOH licensed HDC for at least 3 months; or
- Undergoing an accredited residency training program in IM or Pediatrics (exclusively for training hospitals); or
- General practitioner with work experience in any DOH licensed HDC for at least 6 months.
The POD to HD patient stations ratio must not be more than 1:15 (V.B.2.a.2.b).

Nurse staffing and qualifications

Nurses must provide direct patient care based on DOH rules and approved company policies, prepare materials before dialysis, execute doctors’ orders, assess patients before/during/after dialysis, monitor machine settings, prepare patient access per standards, communicate and initiate interventions, administer medications and document, monitor and record vital signs, perform CPR and ensure documentation, update records each session, inventory e-cart medicines/ward stocks at shift end, protect patients from accidents/hazards/infections, apply proper communication techniques, and provide patient and significant others education (V.B.2.a.3.a).
Nurses must be duly licensed by PRC under R.A. No. 9173 (“Philippine Nursing Act of 2002”) (V.B.2.a.3.b).
Nurses must have a certificate of training in nursing care of renal dialysis patients from competent training providers (V.B.2.a.3.c).
Nurses must have a certificate of training in Basic Life Support (BLS) conducted by competent authorities or professional organizations (V.B.2.a.3.d).
Every HDC must have at least one nurse per shift with updated ACLS training conducted by competent authorities or professional organizations (V.B.2.a.3.e).
The nurse to HD patient stations ratio must not be more than 1:4 (V.B.2.a.3.f).

Dialysis technician and medical records staff

Dialysis technicians must handle equipment care and reprocessing tasks, assess reprocessed dialyzers, label used dialyzers, record dialyzer reuse number in HD flow sheet, store reprocessed dialyzers, perform preventive maintenance/repairs/monitoring, assist the nurse with pre- and post-dialysis assessments and documentation, assist emergency operational procedures and basic CPR measures, and enforce company policies/delegated tasks (V.B.2.a.4).
A designated supervisor of medical records must maintain complete patient medical records within the HDC in accordance with the DOH Hospital Medical Records Manual and acceptable professional standards, and must also function as HDC PRDR Coordinator for medical record keeping and ensuring completeness of forms to be submitted to REDCOP (V.B.2.a.5).
Administrative staff must be provided to facilitate non-medical work in the HDC (V.B.2.a.6).

Physical facilities, spaces, and floor plan

Every HDC must have physical facilities with adequate areas to ensure the safety of staff, patients, and their relatives (V.B.2.b).
Every HDC must conform to applicable local and national regulations for construction, renovation, maintenance, and repair (V.B.2.b.1).
Every HDC must conform to required space depending on workload and services provided (V.B.2.b.2).
Every HDC must have an approved DOH-PTC in accordance with DOH planning and design guidelines through BHFS posted at doh.gov.ph (V.B.2.b.3).

Signed and sealed facility plan

The floor plan must be signed and sealed by a licensed architect and/or engineer (V.B.2.b).
The floor plan must contain the areas listed in the Order’s facility layout requirements (V.B.2.b).

Dialysis service complex areas

Each HD station must not be less than 2 meters by 3 meters to accommodate a dialysis chair or bed, a dialysis machine, and emergency apparatus when needed (V.B.2.b.a.1.a).
Passageways/corridors must be wide enough for access of stretcher and emergency equipment (V.B.2.b.a.1.a).
Each HD station must have electrical convenience outlet(s) (V.B.2.b.a.1.b).
Each HD station must have a water line to deliver treated water to the individual dialysis machine (V.B.2.b.a.1.c).
The nurse’s station with work area must be strategically located for adequate surveillance and must include a work counter, handwashing sink, and storage cabinets including a medicine-preparation counter area (V.B.2.b.a.2).
The water treatment room design must follow the Order’s water treatment system provisions (V.B.2.b.a.3, V.B.2.c.).
A dialyzer reprocessing area/room must be provided for HDC that reprocess (V.B.2.b.a.4).
Each HDC must provide a supply and storage room with storage cabinets for sterile instruments/supplies and other materials (V.B.2.b.a.5).
Each HDC must provide service support areas: waste holding cubicle/area, soiled linen cubicle/area, janitor’s closet, and emergency generator room/area (V.B.2.b.a.6).

Non-treatment/reception areas

Each HDC must provide a business office area with reception/information counter, admitting area, cashier’s area (for non-hospital based HDC), records section, and Medical Director consultation cubicle (V.B.2.b.b.1.a).
Each HDC must provide a room for storage and protection of medical records (V.B.2.b.b.1.b).
Each HDC must provide a waiting area with enough seats for patients and visitors (V.B.2.b.b.2).
Non-hospital based HDC must provide a toilet facility with urinal, water closet, and lavatory for patients and visitors (V.B.2.b.b.3.a).
Hospital based HDC must ensure access to a toilet facility (V.B.2.b.b.3.b).
Each HDC must provide a staff pantry/break room with eating area, counter with sink, locker, and dressing room with toilet for staff use (V.B.2.b.b.4).

Equipment standards and emergency capability

Every HDC must ensure availability and operational readiness of equipment, instruments, materials, and supplies necessary to provide HD (V.B.2.c).
The HDC must provide HD machines and related requirements, dialysis chairs/beds, and an e-cart with specified basic medicines, basic equipment, and basic supplies (V.B.2.c.1–b).

HD machines and hepatitis B segregation

All HD machines must use bicarbonate as buffer (V.B.2.c.1.a.1).
At least one (1) HD machine must be assigned to patients with hepatitis B infection.
If hepatitis B patients are confirmed, they must be referred to a bigger HDC with dedicated machines for them when appropriate (V.B.2.c.1.a.1).

Machine age/grace rules

New machines and refurbished machines with known manufacturing dates must be covered by guidelines not more than 10 years or 30,000 machine hours (equivalent to 7,500 treatments)—whichever comes first (V.B.2.c.1.a.1.a).
Acquisition of refurbished machines with unknown manufacturing dates allowed a 5-year grace period (to be junked by 2013) and such machines must be checked annually (V.B.2.c.1.a.1.b).
Refurbished machine acquisition is not allowed if the manufacturing date and date of purchase cannot be identified in any way possible (V.B.2.c.1.a.1.c).

Patient accommodation

Each HDC must provide dialysis chair(s) capable of full recline and trendelenberg position or patient bed(s) with guard rails (90 cm x 70 cm) or its equivalent (V.B.2.c.1.a.2).

e-cart medicines, equipment, and supplies

Each HDC must provide an e-cart containing the listed basic medicines and specified basic equipment and basic supplies for HD emergency readiness (V.B.2.c.1.a.3; V.B.2.c.1.b; V.B.2.c.1.c).
Basic medicines include, among others, salbutamol 2 mg/ml, D50W 50 ml/vial, amiodarone 150 mg/ampoule, aspirin USP grade 325 mg/tablet, atropine 1 mg/ml, diazepam 10 mg/2 ml and/or midazolam, calcium gluconate 10 mg/ampoule, epinephrine 1 mg/ml, hydrocortisone 250 mg/vial, nitroglycerin spray or isosorbide dinitrate 5 mg/tablet, noradrenaline 2 mg/ampoule, paracetamol 300 mg/ampoule, and tramadol 50 mg/tablet, with quantities stated in the Order (V.B.2.c.1.a.3).
Basic equipment includes specified resuscitation and monitoring tools such as a defibrillator with cardiac monitor and/or pacemaker functions, pulse oximeter, oxygen equipment, suction, glucometer, sphygmomanometer (non-mercurial), and diagnostic sets, among others (V.B.2.c.1.b).
Basic supplies include required consumables and infection-control items such as gloves, sterile gauze, sutures, disinfectants, masks/face shields, puncture-proof sharps container (via bins), and more (V.B.2.c.1.c).

Water treatment and environmental safeguards

The Order mandates HD water safety consistent with AAMI standards through water treatment measures and monitoring (V.B.2.a.1.b.9, V.B.2.c, V.B.2).
Each HDC must have written policies and procedures for storage of water and the appropriate sterilization method(s) used (V.B.2.c.2.c).
Each HDC must provide a standby generator of not less than 20 KVA appropriate to the facility size (V.B.2.c.2.d).
Each HDC must have an equipment calibration, preventive maintenance, and repair program and a contingency plan for equipment breakdown (V.B.2.c.2.e–f).
HD water must be biologically and chemically compatible and must have periodic water analysis (microbiological and chemical) at three (3) sampling points: raw water, product water, and point of use water (V.B.2.g.4).
Microbiological water analysis must be done at least every month and as often as necessary depending on results; bacterial count must be < 200 colonies per milliliter (V.B.2.g.5.a).
Chemical water analysis must be done at least every six (6) months and as deemed necessary following AAMI standards (V.B.2.g.5.b).
Chemical analysis must meet maximum allowable concentrations listed in the Order for contaminants such as Aluminum 0.01, Arsenic 0.005, Cadmium 0.001, Mercury 0.0002, Sodium 70.0, and Zinc 0.1 (V.B.2.g.5.b).
Chemical analysis at only two (2) sampling points (product water and point of use) is allowed for HDC applying for renewal of LTO if there is no change in location; analysis frequency remains every six (6) months and as often as needed (V.B.2.g.5.c).
Each HDC must keep a record of plumbing system disinfection; disinfection must be done quarterly and whenever microbiologic counts reach or exceed acceptable limits, using chemical, heat, or ozone disinfection (V.B.2.g.6).
Each HDC must implement safeguards for proper disposal of infectious wastes and toxic/hazardous substances in accordance with R.A. 6969 and related policy guidelines/issuances (V.B.2.g.7).
Each HDC must implement systems for solid waste management consistent with health care waste management manuals and environmental laws including R.A. 9003 (Ecological Solid Waste Management Act) and the Environmental Sanitation Code (V.B.2.g.7.a).
Each HDC must implement systems for liquid waste management in accordance with revised DOH manual and EMB-DENR policy guidelines/issuances (V.B.2.g.7.b).
Every HDC must implement and strictly enforce a no smoking policy (V.B.2.g.8).
Each HDC must have a contingency plan for accidents and emergencies (V.B.2.g.9).

Service delivery, quality improvement, and records

Each HDC must ensure the HD services delivered meet desired quality standards (V.B.2.f.1).
Each HDC must have documented Standard Operating Procedures (SOP) for HD service provision and for facility operation and maintenance (V.B.2.f.1).
Each HDC must maintain documented technical policies and procedures for services to ensure quality, including HD treatment protocol, reprocessing (if applicable), water treatment, hepatitis/infection prevention and control, complication management, sterilization techniques, infectious waste management, and patient referral/transfer (V.B.2.f.2).
The HDC’s management must ensure blood comes from licensed blood centers or authorized blood stations (V.B.2.f.3).
Blood must be obtained only from DOH-designated blood centers or the Philippine Red Cross (V.B.2.f.3.a).
An MOA must be entered into with hospital facilities capable of blood transfusion and with volunteer donors (V.B.2.f.3.b).

Quality assurance program

Every HDC must establish and maintain a system for continuous quality improvement (V.B.2.e).
Each HDC must have policies and procedures on a Quality Assurance Program (QAP) and continuous quality improvement (V.B.2.e.1).
The QAP must have a written plan and continuous implementation with periodic reviews (V.B.2.e.2).

Information management and medical records content

Each HDC must maintain a record system providing readily available information on each patient (V.B.2.f.1).
Each HDC must maintain complete medical records of all patients within the facility, including patients administering self-care (V.B.2.f.1).
Current files must be kept at the nurse’s station and placed in the patient’s file folder once completed (V.B.2.f.1).
Patient records must be confidential and contain sufficient information to identify the patient and justify diagnosis and treatment, and the patient’s right to obtain records and relevant information must be observed (V.B.2.f.1).
Medical records must include, among others: a summary/face sheet with patient identification, diagnosis, physician contact details, emergency contact, address/phone, date of admission; doctors’ orders with standing orders updated at least semi-annually; dialysis charts; lab/x-ray reports; history and physical exam; vital sign records; medication records; dietary assessments and progress notes; consultations/hospitalizations; nurse progress notes each dialysis; problem list; clinical abstract; informed consent updated at least annually and as deemed necessary; transfer/referral records; advance directive if any; patient education documentation; hepatitis profile (highly recommended); and vaccination status (hepatitis B double dose at 0, 1, 6 months with post-testing 30 days after last dose; influenza annually; pneumococcal every 5 years) (V.B.2.f.1.a–r).
An complications/adverse events logbook must include conditions delaying discharge, hospital admissions following HD, deaths during or immediately after HD, HD-related complications, vascular access complications, disease complications, and outcome categories: death, changed treatment modality, kidney transplant, lost to follow-up, or refused further treatment (V.B.2.f.2).
Each HDC must register patients to PRDR in support of REDCOP of DOH and in coordination with PSN using required REDCOP forms, and submit an annual statistical report to REDCOP (V.B.2.f.3).
Each HDC must maintain administrative records including minutes of meetings, attendance logbook, staff files (including staff vaccination status), and reports of DOH inspection/monitoring activities; hepatitis B staff vaccination at 0, 1, 6 months with routine post-testing 30 days after last dose, influenza annually, and pneumococcal every 5 years are highly recommended (V.B.2.f.4).
Each HDC must maintain technical records including plumbing disinfection records and water analysis reports; HD machine efficiency/machine hours records; inventory cards showing dates of manufacture, acquisition, and installation; calibration schedules; and preventive/corrective maintenance logs (V.B.2.f.5).
HDC must submit data/information required by DOH through BHFS for research, standards setting, improving access to HD services, and similar purposes (V.B.2.f.6).
Retention and disposal of records and relevant information must follow related and future DOH issuances for both paper-based and electronic media (V.B.2.f.7).

Permit to Construct and licensure procedures

DOH-PTC application

A DOH-PTC is issued by DOH through BHFS to an applicant that will establish and operate an HDC, upon compliance with required documents before actual construction (IV.13).
A DOH-PTC is required for HDC with substantial alteration, expansion, or renovation, or increase in number of HD stations (IV.13).
The required documents for DOH-PTC issuance must be accomplished and