Roadmap to Adding a Peritoneal Dialysis Program

What This Guide Is — and What It Is Not

This is a programme-development roadmap for an organisation that already runs dialysis and is deciding whether — and how — to add peritoneal dialysis (PD). It is written for two starting environments. A freestanding dialysis centre (FSDC) usually has dialysis operations, personnel, quality systems, and HD backup, but may need binding external agreements for hospital admission, catheter placement, laboratory and microbiology, pharmacy, imaging, and emergency care. A hospital-based dialysis centre (HBDC) may have those services inside the institution, but must still establish accountable PD workflows, dedicated staff, protected time and space, home logistics, and explicit service-level commitments. Proximity is not the same as validated availability.

The guide deliberately stops where clinical procedure begins. It does not teach how to perform an exchange, connect or disconnect a transfer set, flush a catheter, administer intraperitoneal drugs, change a dressing, collect a specimen, or operate a cycler. It contains no prescriptions, dwell volumes, glucose strengths, ultrafiltration targets, or antimicrobial regimens. Those live in locally approved standard operating procedures (SOPs), in manufacturer instructions, and in the judgement of the accountable clinician — and they change faster than any public page can track. What the guide does supply is the scaffolding around them: who decides, what evidence closes a gate, what stops a launch, and what gets measured afterwards.

Evidence posture and freshness

International guidance is cited as guideline, position paper, or consensus — never as Philippine law. Philippine policy, benefit, and accreditation statements are anchored to primary documents (circulars, advisories, assessment tools) rather than news releases or secondary summaries, and each carries a last-verified marker. Evidence cutoff for this guide is 17 August 2026. Policy, benefit, and accreditation claims must be rechecked within 30 days before any organisation relies on them, and the absence of a located rule is never evidence of permission.

Two phrases are used consistently throughout. local determination marks an operational choice for which no guideline supplies a universal threshold — room size, inventory days, visit frequency, staffing ratio, training duration — and which the implementing organisation must set, source, and defend locally. last verified 17 Aug 2026 marks a Philippine policy claim taken from a primary document as of the evidence cutoff.

Language about study findings follows the source design. Retrospective and observational results are described as associations, not effects. International prevalence and outcome rates are not transposed onto the Philippines. Vendor materials are not treated as guideline evidence, and no clinical recommendation in this guide should reach a patient without extraction and verification against the full source text by a nephrologist and pharmacist.

The Physiology That Earns Every Requirement

Most PD programme checklists read as arbitrary because they arrive as a list. They are not arbitrary. Nearly every operational requirement in this roadmap traces back to four facts about how peritoneal dialysis actually works, and a programme team that holds those four facts can derive most of the checklist rather than memorise it — and can argue sensibly about the parts that genuinely are local judgement.

1 · The dialyser is a living membrane inside the patient

In haemodialysis the semipermeable membrane is a manufactured cartridge: it is inspected, primed, used, discarded, and replaced. In peritoneal dialysis the membrane is the peritoneum — roughly one to two square metres of serosal surface perfused by the splanchnic circulation, across which solutes move by diffusion down concentration gradients and water moves by osmosis, driven in conventional solutions by a glucose gradient acting across small pores and, for free water, across the aquaporin-1 water channels of the capillary endothelium. Three consequences follow immediately, and all three are established physiology.

First, the membrane cannot be swapped out. Anything that injures it — repeated peritonitis, prolonged exposure to high-glucose solutions, chemical irritation — degrades a resource the patient only has one of, and the injury accumulates. That is why an infection episode in PD is not simply an infection to be treated; it is a hit on the organ that makes the therapy possible. Second, membrane transport characteristics vary between people and drift over time within the same person, which is why prescription is an individualised, repeatedly reassessed clinical decision and not a template — and why this guide refuses to publish dwell volumes or glucose strengths. Third, the membrane is only accessible through a permanent breach of the abdominal wall, which brings us to the catheter.

2 · The access is an indwelling foreign body crossing the skin, permanently

A PD catheter is a silicone tube whose intraperitoneal end sits free in the pelvis and whose external end emerges through a tunnelled tract anchored by one or two Dacron cuffs. The cuffs work by provoking a fibrous ingrowth that mechanically fixes the catheter and creates a biological barrier to bacterial tracking along the tunnel — which is precisely why a break-in interval exists at all. Tissue ingrowth takes time; using the catheter before the tract has matured raises the risk of pericatheter leak and of organisms tracking inward along an incompletely sealed path. The ISPD 2019 adult access recommendation covers planning, implantation, postoperative management, and the complication set that follows from this anatomy — malfunction, leak, migration, hernia, obstruction.⁴

This single anatomical fact generates a disproportionate share of the roadmap. It is why the programme needs a credentialed placement route and a rescue route, because a catheter that never functions primarily is not a minor delay — it is a patient without a therapy. It is why insertion-to-use and insertion-to-first-peritonitis are dashboard metrics rather than surgical trivia. It is why exit-site assessment is a scheduled clinical activity rather than wound care. And it is why an FSDC with no reliable interventional or surgical partner has a Phase 0 stop condition, not a Phase 4 procurement problem.

3 · The operator is the patient, in a house, at 2 a.m.

This is the fact that most reliably surprises an established haemodialysis organisation. In HD, the sterile-technique boundary is staffed, supervised, audited, and physically inside the unit. In PD the connect–disconnect step happens in someone's home, several times a day, performed by the person receiving the treatment or by a family member — and touch contamination at that connection is a principal route by which organisms reach a peritoneal cavity that has no meaningful mechanical defence once they arrive. The programme's infection control therefore lives, in practice, inside a teaching relationship rather than inside a policy binder.

That is the mechanistic reason the ISPD treats the PD nurse educator as a central determinant of outcome and devotes a dedicated 2025 position paper to how teaching should be done — trainer capability, learner assessment before teaching begins, adult-learning methods, post-training support, and outcome measurement.¹ It is also the reason competency must be demonstrated rather than inferred from attendance, why retraining triggers exist after infection, hospitalisation, prolonged interruption, or a change of care partner, and why "the trainer got pulled to cover an HD shift" is a safety event rather than a staffing inconvenience. The honest caveat belongs here too: the ISPD 2025 guidance is delivered as practice points and its authors state plainly that high-certainty evidence in teaching PD is lacking.¹ The direction is well supported; the specific numbers — how many days, how many hours, what ratio — are not, and a 2023 scoping review of training programmes found exactly that variation and declined to establish a mandatory duration.¹²

4 · The prescription is delivered physically, by truck, to a house

A PD prescription is not merely an order in a chart; it is several kilograms of sterile fluid per day that must physically reach a specific home, in the correct concentration, unexpired, undamaged, and stored within the manufacturer's environmental limits. There is no clinical workaround for a delivery that does not arrive. This is why the supply chain in this guide is treated as a clinical safety system rather than as procurement, why lot traceability has to reach the home and not merely the warehouse, and why a substitution decision belongs to pharmacy and medicine rather than to logistics.

Why suspected peritonitis is the programme's time-critical pathway

Follow the chain rather than the protocol. Organisms reach the peritoneal cavity — most often via touch contamination at the connection, sometimes along the catheter tunnel from an infected exit site, sometimes transmurally from the bowel. Bacterial proliferation in dialysate provokes a neutrophil influx that produces the cloudy effluent, abdominal pain, and fever that patients report. That inflammatory response is simultaneously the diagnostic signal and the injury: sustained peritoneal inflammation drives mesothelial damage, fibrin deposition, and — with repeated or refractory episodes — the membrane changes and adhesions that end the therapy. Delay therefore costs membrane, not just comfort.

Two operational requirements fall straight out of that chain, and neither is negotiable at launch. The patient must be able to reach a clinician who can act, at any hour, on the day symptoms start — because the point of intervention is early. And effluent must reach a laboratory that will process it, Gram-stain it, culture it, and telephone a result to someone empowered to change therapy — because empiric cover started without a specimen forfeits the organism-directed narrowing that the ISPD 2022 recommendations are built around, and a persistently high culture-negative proportion is usually a specimen-handling defect masquerading as a clinical mystery.² A programme that cannot demonstrate both of those routes on a Sunday night has not failed a paperwork requirement; it has failed the mechanism.

FSDC or HBDC — and What That Changes

The roadmap is identical for both settings; the emphasis differs. An FSDC's critical risks concentrate in external dependencies it does not control: who admits an acutely unwell PD patient at 2 a.m., who places and rescues a catheter within an acceptable interval, whose laboratory processes an urgent effluent specimen on a Sunday, and which HD chair is protected for a temporary transfer. An HBDC's critical risks concentrate in internal assumptions that were never made explicit: the emergency department, wards, operating room, imaging, pharmacy, and microbiology are physically present but may have no idea the PD pathway exists, and the PD nurse can be redeployed to cover a hospital staffing gap unless that time is formally protected.

Before Phase 0 work begins, answer the following organisational questions. None of them ask about patient eligibility, and the answers do not generate a "certified ready" result — they only change which gaps get highlighted first.

Seven Phases, Seven Gates

What a completed roadmap produces

A programme team that works through all seven phases should hold, by the end: an approved business and clinical charter; a local regulatory and payer determination; a defined initial scope and enrolment ceiling; named accountable owners with coverage plans; a catheter-access and urgent-start pathway; a competency-based patient and care-partner education system; an infection-prevention, microbiology, and antimicrobial-stewardship system; validated supply, recall, and disaster-continuity workflows; 24/7 triage, emergency, inpatient, and backup-HD pathways; a controlled document set; a prelaunch simulation record and readiness decision; a dashboard with balancing, outcome, process, equity, and experience measures; and a 30/60/90-day stabilisation review with an explicit scale decision.

Mandate, Need, and Current-State Baseline

Phase 0 answers a question that is easy to skip and expensive to skip: why is this organisation adding PD, and who has authority to stop it? Patient choice, geographic access, capacity relief, disaster resilience, clinical strategy, and payer opportunity are all legitimate reasons. A reason that depends on steering patients toward PD rather than supporting informed modality choice is not, and it should be identified and rejected here rather than discovered later in an enrolment target.

Decisions to make and record

• Why the organisation is adding PD, stated explicitly enough to be argued with.
• Which population and geographic catchment the programme will serve.
• What is explicitly out of scope at launch — assisted PD, APD, urgent starts, pediatric PD, remote islands.
• First-year maximum active census and maximum simultaneous training load.local determination
• Who holds final authority to pause enrolment or treatment operations — named, not "the committee."

Required work

Regulation, Accreditation, Contracting, and Payment

Phase 1 is a verification workflow, not a legal interpretation. The programme's job is to obtain written answers from the offices that control each requirement, retain the evidence, and record who interpreted it. The output is a crosswalk, not an opinion.

Philippine source anchors

PhilHealth Circular No. 2024-0036 established the current Z Benefits Package for peritoneal dialysis, effective 1 January 2025.¹⁴ Its published materials describe adult CAPD packages, infection- and peritonitis-prevention care, training-related and home-assessment elements, and separate pediatric provisions; the accompanying Tamang Sagot is explanatory and does not replace the circular or the provider contract.¹⁵ Treat the circular and its annexes — not a news release, not a summary, and not this page — as controlling until superseded.last verified 17 Aug 2026

A PhilHealth advisory issued in December 2025 identifies pilot sites for pediatric automated peritoneal dialysis.¹⁶ It must not be generalised into adult APD coverage.last verified 17 Aug 2026 Separately, the DOH hospital assessment tool identifies dialysis clinics as haemodialysis, peritoneal dialysis, or both¹⁷ — a useful indication that the regulator recognises the distinction, but not by itself an answer to what an existing facility must file or build. Obtain the current applicable instrument for your facility class from the licensing office in writing.last verified 17 Aug 2026 Privacy obligations for home addresses, delivery manifests, remote monitoring, and vendor portals sit under the Data Privacy Act framework and require institutional Data Protection Officer interpretation.¹⁸

Target Operating Model and Business Case

Phase 2 decides how small the programme will deliberately start. The minimum viable launch model is adult chronic CAPD, planned starts, a defined delivery radius, scheduled clinic hours plus a defined 24/7 clinical escalation route, and a low explicit census ceiling matched to trained staff and inventory. Everything else — assisted PD, APD, urgent-start PD, pediatric PD, nursing-home PD, remote islands, a regional support hub — is a later extension requiring its own gate.

Capacity model

Build an editable capacity model whose inputs are local and visible on the page. No default input should masquerade as a standard; benchmark ranges from the literature are cited separately and the implementer confirms local values.local determination The inputs that actually drive the answer are: active PD census; incident starts per month and attrition; training hours per patient and trainer concurrency; retraining, home-visit, clinic, telephone, and administrative time; nurse leave, sickness, education, and after-hours coverage; nephrologist, dietitian, social-work, pharmacist, access, and technician time; room availability and cleaning turnaround; supply volume, safety stock, storage footprint, expiry, and delivery lead time; expected inpatient, urgent, and backup-HD demand; and claims lag, denials, eligibility changes, and working capital.

Financial model

Separate six cost families rather than presenting one blended number: startup (design, licensing, renovation, furniture, training space, devices, IT, initial stock, staff education, legal and contract work, validation); fixed recurring (protected staff, on-call, rent and overhead, maintenance, software, quality, contracts); variable recurring (solutions, consumables, delivery, laboratory, home visits, waste, medications, complications); shared resources (HD backup, pharmacy, microbiology, inpatient, access, finance, IT — none of which are free just because they are internal); payer cash flow (authorisation, tranches, documentation, lag, denial, reconciliation); and household burden (transport, storage, connectivity, time, care work). Household burden is reported separately and is never treated as a hidden source of provider savings.

Run at least five scenarios — base, low enrolment, higher attrition, supply-cost escalation, and delayed reimbursement — with an explicit assumptions register. Do not assume every eligible patient enrols, every trained patient remains on PD, or shared hospital resources cost nothing.

Detailed Clinical and Operational Design

Design work is organised into twelve workstreams. Each needs an owner, controlled documents, dependencies, measures, a validation method, and an escalation path. Gate 3 requires approved workflows, not drafted policies.

Read the twelve against the four physiological facts rather than as a flat list. Workstreams 3, 5, 7, and 8 exist because an indwelling transcutaneous catheter and an irreplaceable membrane make infection an organ-loss event with a short useful window. Workstreams 1, 2, 4, and 11 exist because the patient is the operator, so capability, home context, and the freedom to change modality without penalty are clinical variables rather than administrative ones. Workstreams 9 and 10 exist because the prescription arrives by truck and the therapy runs unsupervised overnight. Workstreams 6 and 12 are where the programme learns whether any of the other ten are working.

Where the evidence anchors sit

Four of these workstreams have a current international anchor, and it matters that they do not all carry the same evidentiary weight. Infection is the strongest: the ISPD 2022 peritonitis recommendations and the 2023 catheter-related infection update are formal graded guidelines, and they supply the surveillance definitions, classification rules for relapsing/recurrent/repeat episodes, and the programme targets the dashboard depends on.²³ When quoting a specific recommendation from either document into a local SOP, carry its own grade across verbatim — ISPD uses a GRADE-style strength-and-certainty pairing, and a 2C suggestion is not a 1A recommendation.

Access rests on the 2019 adult access recommendation, which is the reference standard for planning, implantation, postoperative management, and complications.⁴ Prescription philosophy rests on the ISPD 2020 goal-directed recommendations — and here the honesty is built into the source itself. Those recommendations were deliberately issued as practice points rather than numerically graded statements, precisely because the authors judged the underlying evidence insufficient to grade; the KDOQI US commentary makes the same observation and adds the point most relevant to a programme being designed from scratch, which is that delivering person-centred, multidimensional assessment requires greater resource allocation, not merely a changed target on a report.⁵⁶ Budget for the clinic time, or the philosophy stays on the wall. Training is the least certain of the four: the ISPD 2025 position paper is likewise delivered as practice points, with its authors stating openly that high-certainty evidence in teaching PD is lacking.¹

Build, Contract, Train, and Provision

Structural and facilities planning

Before any design or renovation work, produce a functional programme — a statement of what each space must do — rather than asking an architect to copy an HD clinic. PD does not need treatment stations arranged like haemodialysis, but it does need controlled training, assessment, supply, specimen, medication, and support workflows. The project team must include the medical director, PD nurse lead, infection prevention, facilities and engineering, safety, pharmacy, laboratory, logistics, accessibility, IT, and the current DOH licensing reviewer.

Required predesign inputs include the approved launch scope, census ceiling, training concurrency, hours, APD status, and projected three-year census; the current DOH assessment tool plus a written interpretation of whether renovation requires a permit, alteration filing, amended LTO, inspection, or other approval; a measured existing-room schedule and workflow rather than floor area alone; mapped flows for patients, care partners, staff, clean supply, returned and quarantined stock, waste, medication, and specimens; an accessibility assessment from arrival through toilet, consultation, examination, training, and emergency egress; an infection-risk assessment for every shared room and service; a storage-volume calculation based on days of inventory, package dimensions, racking, FEFO access, environmental limits, and surge stock; a utilities and equipment schedule; fire, occupational-safety, building, sanitation, and local permit review; a cleaning responsibility and environmental-monitoring plan; and an expansion strategy that does not disrupt an active training programme.

Room and zone data sheet

For every room or zone, record: function · peak occupants · activities · privacy and acoustic need · cleanliness classification · hand-hygiene requirement · casework and storage · equipment · power and data · environmental range · finishes and cleanability · accessible clearances · adjacencies · restricted access · cleaning owner · shared-use conditions · DOH source and interpretation · validation test.

Adjacency and flow rules

• Training sits near assessment and staff support but protected from public traffic, deliveries, waste, and uncontrolled interruption.
• Clean stock travels from receiving and inspection to controlled storage to dispatch without passing through waste or returned-stock holding.
• Returned, damaged, recalled, expired, or temperature-excursion stock is physically and electronically quarantined from usable stock.
• Specimens have a short defined path to packaging and dispatch and do not share uncontrolled surfaces with training supplies.
• Medication receipt, storage, preparation, dispensing, and returns follow pharmacy governance — no improvised medication corner inside general storage.
• The route for an acutely unwell patient connects to assessment and emergency transfer without crossing the training workflow where reasonably possible.
• Shared spaces carry a booking rule, cleaning and turnover standard, equipment reset, and an explicit prohibition on incompatible concurrent use.

Facility commissioning tests

Walk through a complete training day, a high-volume delivery, a stock quarantine, an urgent specimen dispatch, an emergency transfer, after-hours access, a cleaning turnover, an IT and power downtime, and an accessibility journey. Validate actual environmental monitoring and alarms. Furniture, racking, equipment, network, and signage must be installed — not represented by future purchase orders — before the structural gate closes.

Physical zones to provide functionally

Exact design follows current DOH requirements and infection-prevention review. Functionally the programme needs: private assessment and consultation; dedicated training capable of clean workflow and observation; hand-hygiene facilities as required; clinical examination and exit-site review; clean supply receiving and storage with environmental monitoring; quarantine and returned/expired stock segregation; medication storage and preparation under pharmacy policy; sample handling and dispatch; a records and work area protecting confidentiality; waste and occupational-exposure controls; and a workflow that prevents cross-traffic and prevents the space being used as overflow HD capacity.

Workforce competency matrix

Every competency record carries assessor, method, date, result, remediation, expiry or review date, and scope. Attendance is not competency, and a certificate with no scope statement is not a coverage plan.

Minimum controlled-document set

Publish this as an SOP index, not as SOP contents. Each document needs owner, approver, effective date, review date, references, linked forms, training audience, version history, and superseded-document control.

Licensing and Accreditation Are Not One Approval

Licensing, payer accreditation and contracting, facility construction, staffing, device availability, and claims readiness have different owners, different timelines, and different failure modes. Treating them as a single "approval" is how programmes discover in month nine that the LTO scope was amended but the provider contract was never executed — or the reverse.

Never use these terms interchangeably, and never imply that one confers the others.

Sequenced approval register

Regulatory dossier index

At minimum, maintain: corporate authority and facility ownership records; current facility LTO and approved service scope; application, plans, assessment tools, inspection reports, corrective actions, and approval correspondence; medical-director and staff licences, credentials, privileges, training, and coverage; service contracts and memoranda of agreement with hospital, emergency, access, laboratory, microbiology, pharmacy, imaging and intervention, waste, logistics, and backup HD; equipment and product inventory with authorisation status, maintenance, and calibration; infection-prevention, emergency, disaster, quality, records and privacy, pharmacy, laboratory, and waste plans; PhilHealth provider application, contract, effective dates, benefit rules, claims workflows, audit findings, and corrective actions; a permit and renewal calendar with a primary and a backup owner; and a regulatory commitments log recording what was promised during application or inspection and how it is being sustained.

Accreditation readiness tracers

Before the payer relationship goes live, run mock records end to end for: an eligible planned CAPD start; catheter insertion and initiation; training and competency; home assessment; supply issuance with lot traceability; routine follow-up; an infection-prevention service; a suspected complication; temporary HD or hospitalisation; transfer or discontinuation; tranche submission; a denial and appeal; and record retrieval during an audit.

Logistics Is a Clinical Safety System

In a home therapy, the supply chain is part of the treatment. A late delivery is a missed treatment; a wrong lot is a patient-safety event; an unreadable manifest is a privacy breach. Map the chain from demand signal to patient home and back, and assign risk ownership at every handoff.

Network design decisions

Decide and document: suppliers, distributors, contracted and backup carriers, and geographic coverage; centre-held versus supplier-held stock and who owns risk at each handoff; direct-to-home versus centre pickup plus accessible alternatives; standard lead time, order cutoff, delivery windows, failed-delivery response, urgent replenishment, and after-hours pathway; island and remote routes, port and road constraints, typhoon seasons, ferry and air-cargo limits, and alternative staging points; minimum and maximum stock by product, patient, and location based on lead-time variability, expiry, storage capacity, shortage risk, and disaster planlocal determination; manufacturer temperature, humidity, light, stacking, and handling limits; patient privacy across packages, manifests, driver access, SMS content, proof of delivery, and address changes; who may approve a clinical substitution and how affected patients are assessed and informed; reverse logistics for damaged, unused, expired, recalled, or device-related items; and business continuity if a vendor, warehouse, vehicle, port, mobile network, or IT platform fails.

Master data and inventory controls

• One approved item master: generic and product name, SKU, unit of measure, pack conversion, lot, expiry, registration, storage, supplier, approved alternative, and modality compatibility.
• A patient delivery plan tied to the current authorised therapy without exposing prescription decisions to logistics staff.
• Barcode or equally reliable lot and expiry capture at receipt, pick, dispatch, and return.
• FEFO rotation, cycle counting, discrepancy investigation, and home-inventory reconciliation.
• Separate statuses for usable, pending inspection, quarantined, returned, damaged, expired, and recalled stock.
• Dual verification for patient-specific picks and high-risk items.local determination
• Environmental-excursion alerting, quarantine, documented manufacturer or pharmacy disposition, and trend review.
• Consumption-variance flags that trigger clinical review through the PD team, not punitive assumptions about the patient.

Recall and shortage control

A recall simulation must demonstrate that the programme can identify affected lots at the centre and in each home, contact affected people safely, give clinician-approved instructions, quarantine and replace stock, document completion, notify authorities and the manufacturer as required, and reconcile every unit. Shortage plans follow an approved tiered response: confirm extent and duration; protect current patients; review new enrolment; identify authorised compatible alternatives; obtain pharmacy, medical, vendor, and regulatory confirmation; assess retraining and device implications; communicate consistently; track outcomes; and conduct a post-event review.

Disaster inventory model

Use local hazard and route data. Define trigger levels before an event, patient prioritisation without discrimination, pre-positioning limits, environment-controlled items, contact trees, alternate delivery and pickup sites, communication redundancy, receiving-hospital and HD-backup coordination, and recovery and reconciliation. A universal "two-week supply" statement should not be published unless a controlling authority or the manufacturer supports it for the exact scenario.local determination

Logistics gate evidence

Signed supplier and carrier SLAs plus a validated backup route · approved item master and authorisation dossier · storage qualification and environmental-monitoring record · patient-specific order-to-delivery simulation · failed-delivery and urgent-replenishment simulation · complete lot recall simulation · shortage and substitution tabletop with clinical and pharmacy signoff · disaster route and communications test · privacy review of manifests, portals, notifications, and proof of delivery · reconciled starting inventory with no unresolved discrepancy.

End-to-End Validation and Launch Authorisation

Do not validate departments in isolation. Run tracer cases from referral through home support, including documentation and the financial workflow, and observe them in real time rather than reconstructing them afterwards.

Scoring findings

Every finding is classified critical — plausible immediate patient or regulatory risk; blocks launch; major — material reliability gap; must be fixed or formally risk-accepted with a near-term control before first enrolment; or improvement — does not prevent safe launch; assigned and monitored.

Gate 5 signatories

Executive sponsor · medical director · PD nurse lead · infection prevention and microbiology · pharmacy · quality and patient safety · operations and procurement · compliance and licensing · and the receiving hospital or acute-care owner for an FSDC, or the equivalent hospital executive owner for an HBDC. Record dissent, conditions, the enrolment ceiling, the heightened-surveillance duration, and the next review date. A gate decision with no recorded dissent and no conditions usually means the review was not adversarial enough.

Controlled Launch and the First 90 Days

Launch rules

• Start below theoretical capacity.
• Avoid multiple simultaneous first trainings unless the validated model explicitly supports them.
• Prefer patients whose clinical and operational needs match the validated initial scope — and never conceal from them that the programme is new.
• Obtain informed agreement for care and for appropriate use of data; do not frame participation in programme evaluation as a condition of treatment beyond lawful operational data.
• Review every unexpected contact, infection, admission, supply exception, training extension, and workflow workaround rapidly.
• Hold short operational huddles at least weekly during early launch and a multidisciplinary clinical and quality review at an approved cadence.
• Give every team member stop-the-line authority for an immediate safety concern.

The three reviews

Stabilisation, Scale, and Optional Modules

Scale only when clinical and infection outcomes are stable and reviewed with appropriate small-denominator caution; training quality and patient experience are acceptable; staffing has genuine slack for leave, retraining, incidents, and new starts; catheter and rescue access meet service levels; supplies and finances are reliable; home and geographic access are equitable; no unresolved critical or major finding persists; and the next census increment has its own explicit capacity model.

Separately gated modules

Adult APD · assisted PD, guided by the ISPD 2024 position paper together with local workforce and payment rules⁷ · urgent-start PD · pediatric CAPD and APD, using current pediatric infection guidance and the current Philippine pilot or benefit pathway¹⁶ · remote patient monitoring and connected cyclers · regional hub-and-spoke support for smaller centres⁸ · institutional or nursing-home PD.

Each module repeats the full cycle — regulatory, payer, workforce, training, supply and device, privacy, emergency, simulation, and dashboard review. Do not bolt a module on through an SOP amendment alone.

On retention specifically, the evidence is thinner than its citation frequency suggests, and it is worth seeing the actual numbers. A retrospective case-control comparison of a home-visit programme (96 patients with visits versus 92 historical controls) reported a significant reduction in technique failure and a modest extension of time on PD, with no difference in peritonitis or hospitalisation rates.¹⁰ There were eleven technique failures in total across both groups; the case group was also older and less autonomous than the control group, and the design cannot exclude confounding by era. Read it as supportive of home-visit follow-up, not as a demonstration of effect.

The TEACH study is the one randomised trial in this space and remains the strongest single piece of retention evidence: 104 patients starting PD were randomised to frequent home retraining versus conventional retraining, and PD-related infection event rates diverged over time in favour of frequent retraining.¹¹ Its widely quoted subgroup result — an adjusted hazard ratio of 0.01 for first peritonitis in patients aged 60 or over — should be handled with visible caution rather than repeated as a headline: a point estimate that extreme, with a confidence interval spanning two orders of magnitude, arising from a subgroup of a 104-patient open-label trial, is hypothesis-generating. The defensible reading is that structured retraining is a plausible and randomised-evidence-supported infection-prevention intervention whose magnitude of benefit is not well estimated, and whose delivery cost — nurse time, travel, home access — must be modelled locally rather than assumed away.

Finally, the NKF-KDOQI home dialysis conference report supports hub-and-spoke mentoring, peer support, and care-partner respite as growth and retention strategies.⁸ It is a consensus conference report — implementation guidance from an expert panel, useful for programme design and explicitly not a source of local regulation, benefit rules, or outcome projections.

Ten Domains, Two Settings, Five Maturity Levels

Maturity levels

Launch requires level 3 in every critical domain. Scaling expects level 4 in the safety-critical and capacity-limiting domains. A domain rated level 1 — "we have always been able to get a catheter placed when we needed one" — is the single most common source of a critical Phase 5 finding.

Metric Dictionary and How to Read It

Show counts and denominators alongside every rate, especially during a small launch. Use run charts. Avoid league-table interpretation and avoid progress gamification: a completion percentage can hide a critical gap, and a target converted into a staff quota stops measuring anything useful.

Clinical and infection measures

Access and process measures

CKD patients receiving documented modality education before KRT · referral-to-education, decision-to-access-referral, referral-to-insertion, insertion-to-ready, and ready-to-home intervals · primary catheter function, early leak, migration or flow dysfunction, revision, removal · unplanned HD before or after an intended PD start · training duration and competency attainment (without setting speed as a quality target) · retraining due and completed, home reassessment due and completed · call response, urgent review, laboratory pickup, preliminary and final microbiology, and critical-result response times · stockouts, late or incomplete deliveries, wastage and expiry, recall trace completeness.

Person-centred and equity measures

Patient-reported symptom and treatment burden and life-goal review · patient and care-partner training experience and confidence · care-partner strain where relevant, with consent and a support pathway · modality education, offer, choice, start, and retention stratified where lawful and meaningful by age, sex, geography, payer, disability or access need, and socioeconomic proxy · reasons for non-start or discontinuation coded without blame · complaints, shared-decision quality, and involuntary-transfer review.

Workforce and finance balancing measures

PD nurse workload, overtime, on-call contacts, vacancy, leave coverage, and turnover · concurrent training load and starts delayed by capacity · claim acceptance and denial, days to payment, unbilled services, and household cost signals · HD backup use and its effect on HD capacity.

Twelve Artifacts to Build — and Five Not to

These are the working documents a programme team should hold by Gate 5. Each is deliberately a local artifact: it stores the organisation's own answers, keeps no patient-identifiable data, and prints with its version, evidence cutoff, unresolved findings, and the professional-use warning intact.

The Authoritative Spine and How to Keep It Current

Evidence language rules for anyone editing this guide

Programme documents drift toward false confidence in a predictable way: a mechanism becomes a benefit, a benefit becomes a target, and a target becomes a promise made to a board. The defence is to match the verb to the rung of the ladder every single time.

• Use "recommends," "suggests," or "practice point" according to the source, and preserve the source's own grading vocabulary — never silently convert one grading system into another, because a GRADE 2C and an ungraded practice point carry different information and a reader cannot recover what was lost.
• Where a source declined to grade a statement — as the ISPD 2020 prescription recommendations and the 2025 teaching position paper both did — say that it is a practice point rather than implying a strength that does not exist.
• Call retrospective and observational findings associations, not effects, unless the design supports causal language.
• Pair every effect estimate with its denominator and its absolute size. Eleven events across 188 patients is a signal to investigate, not a proven effect, and a hazard ratio without an event count is uninterpretable.
• Label surrogate measures as surrogates. Clearance is a surrogate; symptom burden, hospitalisation, technique survival, and death are not.
• Do not infer Philippine prevalence or outcome rates from international cohorts.
• Do not treat vendor materials as guideline evidence.
• Mark operational choices as local determination when guidelines supply no universal threshold.
• Clinical recommendations must be extracted and verified against full text by a nephrologist and pharmacist before they reach a patient. A summary — including this one — is not a substitute.

Review cadence

Recheck Philippine policy and benefit sources quarterly and within 30 days before publishing any material that relies on them; conduct a full clinical evidence review at least annually; and trigger an immediate review whenever ISPD, DOH, or PhilHealth issues a change. Every source in the verification log carries: source ID, title, issuing body, publication and effective date, version, supersedes/superseded-by, URL, access date, applicable setting and population, the exact claim it supports, page or section, evidence type, limitation, reviewer, next review date, and status.

Questions Programme Teams Actually Ask