Law Summary
Objective
- Establishes guidelines to implement Sections in A.O. No. 2012-0001 regarding Water Treatment Area and Environmental Management at dialysis centers.
Scope of Application
- Applies to all DOH licensed dialysis facilities, accredited laboratories, Bureau of Health Facilities and Services (BHFS), and Center for Health Development (CHD).
Definitions
- Key terms defined include: AAMI standards, BHFS, CHD, contamination, decontamination, cleaning, disinfectant, dialysis clinic, types of microbial contaminants, License to Operate (LTO), Reverse Osmosis (RO), and Total Dissolved Solids (TDS).
Implementing Mechanisms
General Guidelines
- Compliance with guidelines mandatory prior to LTO issuance and ongoing.
- Only DOH-accredited labs can conduct water tests.
- Labs must promptly notify HDCs and monitoring offices of water quality issues.
- RO water systems require regular maintenance by licensed companies at least monthly.
- Medical Directors are accountable for water quality safety and must actively monitor.
- Compliance with all relevant policies and tools is required.
Specific Guidelines
- Water samples must be collected at three points: raw water, product water (post-RO), and point of use.
- Microbiological analysis monthly at all points; chemical analysis every six months at point of use.
- TDS monitored weekly; corrective actions if above 10 mg/L.
- Sampling must be done by DOH-accredited personnel or properly managed by HDC staff under supervision.
- Clear procedures and sterile techniques mandated for sampling to avoid contamination.
Reporting and Laboratory Standards
- Accredited labs must include detailed sample and test information in reports, signed by authorized signatories.
- Test results categorized as Pass/Fail against AAMI standards.
- Report copies sent to HDC and DOH; immediate alerts issued for failed results.
Procedures for Exceeding AAMI Limits
- Immediate cessation of operations required until issues resolved.
- Investigation to identify contamination sources.
- Corrective measures include cleaning, disinfection, membrane replacements.
- Repeat testing mandatory post-correction.
Fees
- Laboratory fees must be reasonable and conform to BHFS schedule.
Violations
- Penalties include suspension or revocation of LTO.
- A failed water test alone is not a violation, but failure to correct is.
Investigation of Charges
- BHFS or CHD authorized to investigate violations.
- License cancellation or revocation possible.
- Criminal charges may be pursued.
Penalties
- Follow existing A.O. guidelines on violations.
- Preventive suspension up to 60 days possible on violation discovery.
- Suspension includes cessation of operations and patient acceptance.
- Violating suspension can lead to LTO revocation.
Appeal Process
- Facility management may appeal decisions within 10 days to the Secretary of Health.
- Secretary's decision is final.
Repealing Clause
- Inconsistent prior provisions repealed or modified accordingly.
Separability Clause
- If any part declared invalid, remaining provisions stay effective.
Effectivity
- Order effective 15 days after approval and publication.