QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2013-0003)
To provide implementing guidelines on the analysis, monitoring, and maintenance of water used in dialysis facilities (HDCs) pursuant to DOH Administrative Order No. 2012-0001, specifically covering requirements on the Water Treatment Area and Environmental Management.
All DOH-licensed dialysis facilities (HDCs), DOH-accredited laboratories capable of microbiological and chemical analyses of dialysis water, and BHFS and CHD.
Only water laboratories accredited and recognized by DOH may conduct tests for microbiological and chemical contaminants in dialysis facilities.
They must send an INFO ALERT (via text message, email, fax, and phone call) to the concerned HDC and the Licensing and Monitoring Divisions of BHFS/CHD.
The Medical Director is responsible for ensuring water quality in the HDC, including assuring water safety at all times and documenting involvement in monitoring (e.g., attendance to HDC meetings and initials on test results after review).
1) Raw water, 2) Product water, and 3) Point of use.
From the water before it enters any part of the water treatment system; it may be taken from a sink near the water treatment room as long as it has not been treated in any way.
From a sample port immediately after the RO system (e.g., at the point leaving the RO before a holding tank or treatment room for a direct system; at the point where the water leaves the holding tank if present; or at the point where water enters the dialyzer reprocessing system).
At least every month at the three sampling points. Limits: HPC less than 200 CFU/mL, and fecal coliform less than 1.1 MPN/100 mL.
Chemical analysis is required at a minimum of one (1) sampling port—point of use—before initial operation of the HDC and at least every six (6) months thereafter.
TDS of product water must be performed, monitored, and recorded weekly in the HDC logbook; corrective measures must be done when TDS is found above 10 mg/L.
Sample ports must be rinsed for at least one minute at normal pressure and flow rate before drawing samples; samples must be collected using a clean catch technique to minimize contamination and reduce false positive results.
HDC staff may send samples via courier to a DOH-accredited laboratory recognized by DOH. For microbiological tests, samples may also be collected and sent to a local DOH-accredited water laboratory within the vicinity. Chemical samples may be couriered to a DOH-accredited laboratory qualified to meet AAMI chemical standards until DOH identifies adequate local chemical-testing laboratories.
For microbiological testing (HPC/fecal coliform), water must be contained in a sterilized bottle, properly marked and labeled, with a volume of two hundred (200) mL.
The HDC must temporarily cease operations until the repeat test of the failing parameter(s) complies with the standards, perform corrective actions (e.g., review suspected cause, clean/disinfect RO membranes, disinfect distribution loop, disinfect dialysis machine hoses), notify patients, and conduct re-sampling and re-testing.
A failed test is a failure of the water treatment system and may not necessarily constitute a violation; however, failure of the HDC to immediately revert the failing parameter is considered a violation.