Guidelines for Water Quality in Dialysis

Legal basis and related framework

DOH Administrative Order No. 2013-0003 implements specific requirements under Section V, B.2.c.1.b (Water Treatment Area) and Section V.B.2.g.4 (Environmental Management) of DOH Administrative Order No. 2012-0001.
The Order establishes operating and compliance guidelines tied to the dialysis licensure and regulation framework under DOH Administrative Order No. 2012-0001.
Violations and penalties are governed by DOH Administrative Order No. 2007-0022 (Violations Under the One-Stop Shop Licensure System for Hospitals) and DOH Administrative Order No. 2008-0028 (Violations Under the One-Stop Shop Licensure System for Non-Hospital Based Facilities), and their related issuances, plus the additional enforcement rules in this Order.
Defined concepts such as Contaminated, Decontamination, Cleaning, Disinfectant, and Disinfection are anchored to Annex B of DOH Administrative Order No. 2012-0012 (Rules and Regulation Governing the New Classification of Hospitals and Other Health Facilities in the Philippines).

Policy objective and clinical rationale

Water treatment systems for dialysis are required to function properly because water is a critical hazard factor in overall dialysis care.
Dialysis water must receive additional treatment to minimize exposure to microbiologic and chemical contaminants that may exist in drinking or tap water.
Water purification is designed to remove metals, electrolytes, bacteria, and pyrogens from feed or raw water.
The Order aims to improve patient safety by ensuring water treatment systems support biologically and chemically compatible dialysis water techniques, including more stringent microbiologic purity and ultraclean dialysis fluid practices.

Coverage, application, and defined terms

The Order applies to all DOH licensed dialysis facilities (HDCs).
The Order applies to DOH accredited laboratories with capability for microbiological and chemical analyses of water in HDC.
The Order applies to BHFS and CHD.
BHFS is the DOH regulatory agency responsible for implementation of the guidelines under this Order.
CHD is the regional health office of DOH for enforcement and investigation through its Director or authorized representatives.
The Order defines key terms used for compliance, including Association for the Advancement of Medical Instrumentation (AAMI), Hemodialysis Clinic (HDC), License to Operate (LTO), Reverse Osmosis (RO), Heterotrophic Plate Count (HPC), Total Coliform, Fecal Coliform, and Total Dissolved Solids (TDS), and it provides technical descriptions and intended indicator purposes for microbiological parameters.

Implementation: general compliance duties

Every HDC must comply with these guidelines at all times prior to issuance of LTO and after issuance.
Only water laboratories accredited and recognized by DOH may conduct tests for the presence of microbiological and chemical contaminants of dialysis facility water.
Accredited laboratories must send an INFO ALERT by text message, email, fax, and phone call to the concerned HDC and to the Licensing and Monitoring Divisions of BHFS/CHD when results exceed AAMI standards of maximum allowable concentration/limits.
Every HDC must maintain records showing that RO water systems are maintained and monitored by licensed and reputable companies.
Major preventive maintenance on RO water systems must be done at least monthly and whenever the need arises.
The Medical Director is responsible for water quality in the HDC in accordance with Section V.B.2.a.1 of DOH Administrative Order No. 2012-0001, and must assure water safety at all times.
The Medical Director must be involved in monitoring and the HDC must document this involvement through attendance to HDC meetings and affixing initials to test results to indicate review.
Stakeholders must comply with the standards and requirements under DOH Administrative Order No. 2012-0001, its licensure assessment tools for HDC, this Order, and other related policy guidelines/issuances.

Implementation: sampling, testing, reporting, and actions

Dialysis facility water sampling must occur at three (3) points:
- Raw Water: collected from water before it enters any part of the water treatment system (e.g., from a sink near the water treatment room) provided it has not been treated.
- Product Water: drawn from a sample port immediately after the RO system, ensuring no contaminant levels exceed AAMI standards and requiring comparison with past test results through trend analysis.
- Point of Use: drawn at a point close to or approaching the dialysis equipment.
Product water sampling points include any of the following locations:
- where water leaves the RO machine before it enters the holding tank (Indirect System) or before it goes to the treatment room (Direct System),
- where water leaves an RO holding tank (if present),
- where water enters the dialyzer reprocessing system (manual or automated).
Periodic water analysis must follow these schedules:
- Microbiological analysis: at least every month at the three (3) sampling points, with limits of:
  - HPC less than 200 CFU/ml,
  - Fecal Coliform less than 1.1 MPN/100 ml.
- Chemical analysis:
  - Periodic water analysis for chemical tests at the three (3) sampling points is required only as amended to require microbiological testing at three (3) points before initial operation and monthly thereafter.
  - Chemical testing must be performed at one (1) sampling point: point of use before initial operation and every six (6) months thereafter.
  - For HDC applying for renewal of LTO, chemical analysis at two (2) sampling points (product water and point of use) may be allowed if there is no change in location, and the frequency must be every six (6) months and as often as needed.
- TDS monitoring: TDS of product water must be performed, monitored, and recorded weekly in the HDC logbook, and corrective measures must be done when TDS is found above 10 mg/L.
Sampling and collection must follow these rules:
- After logistics are established, only staff from DOH-accredited laboratories may collect water samples from dialysis facilities.
- Sample ports must be rinsed for at least one (1) minute at normal pressure and flow rate before drawing samples.
- Sampling must use a “clean catch” technique to minimize contamination and false positives.
- If a sample port is not present, an appropriate sample port should be installed.
- For HDC in NCR and nearby provinces (including Laguna, Cavite, Batangas, Bulacan, Pampanga, Rizal, and Bataan), water sampling must be conducted by staff from a DOH-accredited and recognized laboratory.
- For HDC outside NCR, samples may be sent by courier by HDC staff to a DOH-accredited and recognized laboratory; microbiological samples may be collected and sent to a local DOH-accredited water laboratory within the vicinity; chemical samples may be sent by courier to a DOH-accredited chemical-capable laboratory until DOH identifies laboratories outside NCR that can meet AAMI chemical standards.
- The head of HDC must supervise staff in sampling and collection.
- If laboratory-accredited sampling is impossible:
  - Microbiological samples must be sent within six (6) hours after collection to a local DOH-accredited water laboratory qualified for microbial testing.
  - Chemical samples may be sent through courier or transported to a DOH-accredited chemical-testing laboratory if samples are kept chilled inside an ice chest.
Client information obligations require providing analysis-requesting clients the following items, including:
- Sampling and Analysis (Microbiological and Chemical Analysis based on AAMI Standards),
- Volume Sample,
- Container of sample,
- Collection, handling and storage of sample,
- Identification of samples,
- Frequency of sampling,
- Location of sampling points,
- Method of Analysis.
Required sample containers and volumes:
- Microbiological testing sample must be in a sterilized bottle, properly marked and labeled, with volume of two hundred (200) ml.
- Chemical testing sample must be in a clean bottle(s), properly marked and labeled, with volume of at least one (1) gallon.
- Collection procedure requires flushing water from sampling ports, letting water flow for three (3) minutes, collecting using “clean catch,” and covering the bottle immediately after representative sampling.
The required reporting contents include:
- Name of HDC and address where samples were taken,
- Date and time samples were taken,
- Person who conducted sampling,
- Identification of samples, description, and condition,
- Date sample received by the laboratory,
- Date sample analyzed,
- Date of final report.
The laboratory test report must be structured with parameter fields including:
- For microbial tests:
  - HPC < 200 CFU/mL,
  - Fecal Coliform < 1.1 MPN/100 mL,
  - a passed/failed requirement field and remarks.
- For chemical tests, the laboratory must list parameters and maximum allowable concentrations and use a passed/failed remarks approach, including:
  - Aluminum 0.01 mg/L, Arsenic 0.005 mg/L, Barium 0.1 mg/L, Cadmium 0.001 mg/L, Calcium 2.0 mg/L, Chloramines 0.1 mg/L, Free Chlorine 0.5 mg/L, Chromium 0.014 mg/L, Copper 0.1 mg/L, Flouride 0.2 mg/L, Lead 0.005 mg/L, Magnesium 4.0 mg/L, Mercury 0.0002 mg/L, Nitrate (as N) 2.0 mg/L, Potassium 8.0 mg/L, Selenium 0.097 mg/L, Silver 0.005 mg/L, Sodium 70.0 mg/L, Sulfate 100.0 mg/L, Zinc 0.1 mg/L.
The final report must be signed by authorized laboratory signatories attesting to accuracy of all entries.
The laboratory must submit the final report to the HDC where samples were taken and must forward an INFO ALERT for failing samples to the concerned HDC and DOH as required under Item V.A.3.
When AAMI water standard limits are exceeded:
- The HDC must ensure decontamination and disinfection of water treatment systems and dialysis machines periodically and whenever necessary.
- The HDC must temporarily cease operations until repeat testing shows compliance for the failing parameter(s).
- The HDC must perform corrective actions including isolation and review of:
  - levels of bacteria exiting the RO machine,
  - product water distribution system disinfection procedures,
  - distribution piping for dead spots contributing to bacterial contamination.
- Corrective action must be undertaken in the suspected cause area and may include:
  - cleaning and disinfection/replacement of RO machine membranes,
  - disinfection of product water distribution system including the entire loop,
  - disinfection of the water hose on the dialysis machine.
- The HDC must conduct re-sampling and re-testing of the affected parameter.
- The HDC must notify its patients of the situation while corrective measures are undertaken.

Fees, violations, investigation, and penalties

Laboratory fees for water analyses in HDC must be reasonable, enough to cover services rendered, and must follow the approved schedule of fees by BHFS.
Stakeholders violating any provision of the guidelines and related issuances and/or committing commission/omission acts by facility personnel are penalized and may have the LTO suspended or revoked.
A failed test is treated as a failure of the water treatment system, and it does not automatically constitute a violation.
Failure of the HDC to immediately revert the failing parameter constitutes a violation.
Complaints and charges must be investigated by BHFS, or the Director of CHD, or authorized representatives.
After investigation, BHFS or the Director of CHD may suspend, cancel, or revoke the LTO/Certificate of Accreditation of licensees found violating this Order and related issuances.
Enforcement actions are without prejudice to taking the case to judicial authority for criminal action.
Penalties for violations are imposed in accordance with DOH Administrative Order No. 2007-0022 and DOH Administrative Order No. 2008-0028 and their related issuances, plus this Order’s specific preventive suspension rule.
BHFS may immediately impose preventive suspension if an inspection or monitoring visit finds violations or prohibited acts under this Order, for not more than sixty (60) days.
During preventive suspension, the HDC must cease operations and must not accept patients for hemodialysis.
Any violation of the preventive suspension is a ground for revocation of LTO.
Appeals must be filed by the aggrieved health facility management within ten (10) days from receipt of the notice of decision by filing a notice of appeal to the Office of the Secretary of Health.
BHFS must certify and file a copy of the decision and all documents and transcript of hearings with the Office of the Secretary for review.
The Secretary of Health’s decision is final and executory.

Repeal, separability, and effectivity

Provisions from previous issuances that are inconsistent or contrary to this Order are repealed and modified accordingly.
If any provision or part is declared unauthorized or invalid by a court of law or competent authority, the remaining provisions remain valid and in force.
The Order becomes effective fifteen (15) days after its approval and publication in a newspaper of general circulation.