QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2012 ~ 0001)
To prescribe revised minimum standards for Hemodialysis Clinics (HDC) in order to ensure safe, effective, quality and efficient hemodialysis (HD) services, addressing gaps found in earlier compliance and standards.
To all government and private Hemodialysis Clinics (HDC) in the Philippines, whether hospital-based or non-hospital based.
DOH, through BHFS, shall advocate PhilHealth accreditation standards and requirements on PD.
All HDCs shall participate in PRDR, and all patients on HD must be registered by these facilities to PRDR.
DOH-PTC (Permit to Construct) is issued by BHFS as a prerequisite before actual construction/major alterations and is required for HDC with substantial alteration/expansion/renovation or increased HD stations. LTO (License to Operate) is the authority to operate the HDC.
A physician licensed by PRC, preferably a nephrologist certified by the Philippine Society of Nephrology (PSN). Duties include overseeing technical/medical operations, ensuring procedures follow acceptable medical norms, developing internal medical protocols, setting education/training requirements for staff, ensuring QAPI activities, ensuring infection control compliance, and ensuring water safety per AAMI standards.
In order of priority: (1) Board eligible in nephrology; (2) Board certified in Internal Medicine (IM) or Pediatrics with at least 3 months work experience in any DOH-licensed HDC; (3) Board eligible in IM or Pediatrics with at least 3 months work experience; (4) General practitioner with at least 6 months work experience in any DOH-licensed HDC. Training for non-nephrologists follows PSN guidelines.
The Medical Director shall handle a maximum of only three (3) HDC.
The POD must be duly licensed by PRC and meet one of the specified qualification pathways (e.g., board certified/eligible in nephrology; board certified/eligible in IM or Pediatrics with required HDC work experience; undergoing accredited IM/Pediatrics residency training in training hospitals; or GP with required HDC experience). The POD must be present during hours of operation of the HDC.
Not more than 1:15 (POD to number of HD patient stations).
Not more than 1:4 nurse-to-number of HD patient stations. Each HDC must have at least one nurse per shift with updated ACLS training conducted by competent authorities or professional organizations. Nurses must be PRC-licensed and have training certificates in renal dialysis nursing care and BLS.
The e-cart must contain basic medicines, equipment, and supplies for emergency preparedness in HD. Examples of basic medicines include: Epinephrine 1 mg/ml ampoule and Hydrocortisone 250 mg/vial (other medicines are also enumerated).
New machines and refurbished machines with known manufacturing dates must follow existing guidelines not more than 10 years or 30,000 machine hours (equivalent to 7,500 treatments), whichever comes first. Refurbished machines acquired January 2009 or existing refurbished machines with unknown manufacturing dates have a 5-year grace period (to be junked by year 2013) with annual checks. Refurbished machine acquisition is not allowed if manufacturing and purchase dates cannot be identified.
Every HDC must ensure water safety using AAMI Standards. It must have written policies for water storage and sterilization, treat water for HD purposes, and conduct periodic water analysis with specified frequency and sampling points (e.g., microbiological analysis at least monthly at three sampling points; chemical analysis at least every six months and using specified maximum allowable concentrations).
For DOH-PTC: submit required documents to BHFS before construction (including application form, proof of ownership, and signed/sealed floor plans, plus feasibility study). BHFS reviews and may approve or disapprove; only one revision is allowed; then DOH-PTC is issued. For initial LTO: applicants submit a duly accomplished form and attachments to BHFS; hospital-based HDC follows OSS licensure for hospitals; non-hospital based HDC follows OSS for non-hospital based dialysis clinics.
The HDC’s LTO shall be cancelled automatically without notice upon failure to submit a duly accomplished application form and failure to pay the proper fee within 30 calendar days after the expiration date stated on its license; the HDC shall cease operation and apply for a new/initial LTO.
A Hemodialysis Clinic or its personnel aggrieved by the decision of the BHFS Director or CHD may file a notice of appeal within 10 days after receipt of the notice of decision to the Office of the Secretary of Health. The Secretary’s decision is final and executory.