Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 2013-0003)
The main purpose is to set guidelines for the analysis, monitoring, and maintenance of water used in dialysis facilities to ensure the safety and quality of water treatment systems in accordance with DOH Administrative Order No. 2012-0001.
It applies to all DOH licensed dialysis facilities, DOH accredited laboratories capable of conducting microbiological and chemical analyses of water in Hemodialysis Clinics (HDC), the Bureau of Health Facilities and Services (BHFS), and Center for Health Development (CHD).
The Medical Director of the Hemodialysis Clinic is responsible for the water quality and safety, including monitoring and reviewing water analysis results.
The three sampling points are: (a) Raw water – before any treatment, (b) Product water – immediately after the RO system, and (c) Point of use – near or at the dialysis equipment.
Microbiological analysis must be done at least every month at the three sampling points (raw water, product water, and point of use).
Chemical analysis is required at the point of use before initial operation and every six (6) months thereafter.
HPC must be less than 200 CFU/ml and Fecal Coliform must be less than 1.1 MPN/100 ml.
The facility must temporarily cease operations until repeat tests comply with standards, perform corrective actions including cleaning and disinfection of the treatment system and dialysis machines, re-sample, and notify patients.
Penalties include suspension or revocation of the License to Operate (LTO), preventive suspension for up to 60 days, and possible criminal charges according to existing DOH Administrative Orders.
The Bureau of Health Facilities and Services (BHFS), the Director of the Center for Health Development (CHD), or their authorized representatives investigate violations, impose sanctions, and may suspend, cancel, or revoke licenses.
Yes, aggrieved management can file a notice of appeal to the Office of the Secretary of Health within ten (10) days after receipt of the decision. The Secretary’s decision is final and executory.
Only DOH-accredited and recognized laboratories are authorized to perform microbiological and chemical analyses of water in dialysis facilities.
Reports must include the name and address of the HDC, date and time of sampling, name of person conducting the sampling, sample identification, dates received and analyzed, results, method used, maximum allowable limits, and remarks (pass or fail). The report must be signed by authorized signatories.
Decontamination is the use of physical or chemical means to remove or destroy bloodborne pathogens rendering the surface safe. Cleaning is the removal of visible soil, blood, proteins, microorganisms, and debris by manual or physical processes preparing items for safe handling or further decontamination.