How [CLIENT PROGRAM] Achieved FACT Accreditation for [CAR-T / HCT] Under the 9th Edition Standards

Client Overview

The Challenge

Option A — Community Oncology New CAR-T Program

[CLIENT], a [X]-bed community hospital with an established oncology program, had been referring eligible lymphoma and myeloma patients to academic centers [X] miles away for CAR-T therapy. With CAR-T moving from salvage to second-line standard of care for [indication], the oncology leadership determined that building a FACT-accredited CAR-T program in-house was both clinically appropriate and financially necessary — the referral volume represented [X] patients per year at $375,000–$450,000+ per infusion.

The challenges: (1) No internal FACT accreditation expertise; (2) No existing Quality Management Plan or cellular therapy SOP library; (3) Apheresis center existed but was not FACT-compliant; (4) No existing written agreements with commercial manufacturers; (5) Limited dedicated quality management FTE available. The program needed full-cycle consulting support to build the FACT infrastructure from scratch.

Option B — Academic Center 9th Edition Transition

[CLIENT], an academic transplant center with [X] years of FACT HCT accreditation and an active IEC (CAR-T) program, needed to update its Compliance Crosswalk and affected SOPs for the FACT-JACIE 9th Edition effective February 2, 2026. The primary challenges were:

1. Consolidated Collection Standards — the program collected peripheral blood, bone marrow, and TILs under separate SOP frameworks; the 9th Edition required consolidation into a unified Collection section
2. New REMS Standards — ASTCT 80/20 Task Force requirements now formally incorporated into FACT; the program needed to demonstrate REMS compliance within the FACT Crosswalk
3. ISBT 128 Labeling for Further Manufacturing — the program had begun supplying apheresis products to a pharma manufacturing partner; the 9th Edition required ISBT 128 labeling from collection for these products

Option C — Apheresis Center: Collection for Further Manufacturing

[CLIENT HOSPITAL]'s apheresis center had been approached by [PHARMA COMPANY] to supply leukapheresis starting materials for CAR-T manufacturing. The contract required FACT accreditation for the Collection for Further Manufacturing specification — a requirement added to FACT standards in 2024. The apheresis center was not previously FACT-accredited and needed to build the compliance infrastructure from the 2024 specification requirements before the manufacturing contract could be signed.

Baseline Assessment Findings

IHS conducted an initial gap analysis against 9th Edition requirements and identified:

• [GAP 1: e.g., No Quality Management Plan — no documented quality philosophy, no management review records, no quality indicators, no CAPA system]
• [GAP 2: e.g., No chain-of-custody documentation system — product identity verification relied on verbal confirmation, not documented traceability]
• [GAP 3: e.g., Written agreements with Novartis and Kite-Gilead not in place — no formal documentation of manufacturer vs. clinical site responsibilities]
• [GAP 4: e.g., EMR system (Epic) not formally validated for cellular therapy tracking — no IQ/OQ/PQ documentation]
• [GAP 5: e.g., Training records for [X] of [Y] nursing staff lacked documented annual competency assessments for CAR-T toxicity management]
• [GAP 6: e.g., ISBT 128 labeling not implemented — all products labeled under non-standardized institutional system]
• [Additional gaps as applicable]

IHS Approach

Phase 1 — Eligibility Confirmation and Registration (Month 1)

IHS confirmed the program met FACT minimum volume requirements: [X] [allogeneic / autologous / IEC] patients in the preceding 12 months, exceeding the FACT minimum of [10 allogeneic / 5 autologous / IEC threshold]. Business Associate Agreement signed and registration fee paid. FACT accreditation portal initiated.

Phase 2 — Compliance Crosswalk and SOP Development (Months 1–12)

IHS built the Compliance Crosswalk — the central document mapping every FACT standard to [CLIENT]'s internal policies, SOPs, and quality documents. Key deliverables:

• Quality Management Plan — overarching QMP with quality philosophy, organizational chart, management review protocol (quarterly), quality indicators ([X] defined metrics), audit schedule, and CAPA system
• SOP Library — [X] SOPs developed or revised, covering: CAR-T product receipt and storage, apheresis procedure, chain-of-custody documentation at every transfer point, REMS-required patient monitoring, CRS/ICANS management, adverse event reporting, and personnel competency assessment
• Written Agreements — formal written agreements executed with [Novartis / Kite-Gilead / BMS / Janssen] specifying manufacturer vs. clinical site responsibilities for product ordering, release testing, administration, and adverse event reporting
• Facility Grids — architectural and operational mapping for Clinical Facility, Apheresis/Collection Facility, and Cell Processing Laboratory
• IT Validation — IQ/OQ/PQ validation documentation for Epic modules used for cellular therapy tracking and the LIMS used in the processing laboratory
• Personnel Documentation — [X] training and competency assessment records completed across clinical, apheresis, and laboratory staff; credentialing documentation compiled for Medical Director, Processing Laboratory Director, and Quality Manager
• ISBT 128 Implementation — labeling system implemented for all cellular therapy products; chain-of-custody documentation updated to ISBT 128 format per 9th Edition requirements
• REMS Integration — REMS program compliance documentation incorporated into Crosswalk per 9th Edition requirements

Phase 3 — Desk Review and RFI Management (Months 12–14)

FACT's Accreditation Coordinator conducted an off-site review of uploaded documentation and issued [X] Requests for Information. IHS managed all RFI responses, providing supplemental documentation or revised SOPs within FACT's required response windows. All RFIs closed within [X] weeks without requiring documentation resubmission.

Phase 4 — Mock Inspection (Month [X])

IHS conducted a full mock inspection using a team of [X] consultants with direct FACT inspection experience. The mock inspection included:

• Chain-of-custody trace for [X] actual patient products — from collection through infusion documentation
• Live procedure observation: [apheresis collection / CAR-T infusion / product receipt and storage]
• Staff interviews: Medical Director, Quality Manager, Cell Processing Laboratory Director, [X] nurses, [X] apheresis technicians, [X] lab technicians
• Physical facility evaluation: cryogenic storage temperature log review, equipment qualification documentation, cleanroom environment monitoring records
• SOP floor audit: verifying that staff are using current SOP versions and procedures match documented protocols

The mock inspection identified [X] remaining gaps, all remediated before the official inspection was scheduled.

Phase 5 — FACT On-Site Inspection and CAPA (Months [X]–[X])

FACT deployed a [X]-person inspection team of volunteer peer inspectors — [specialist roles]. The inspection ran [X] days. [X] citations were issued / No citations were issued. IHS authored CAPA responses for all cited deficiencies, with specific documentary remediation for each finding. FACT Accreditation Committee accepted the CAPA and awarded accreditation.

Results

Client Perspective

"[CLIENT QUOTE — e.g., We knew we needed FACT accreditation but had no idea where to start. IHS built everything from scratch — the QMP, every SOP, the manufacturer agreements, the IT validation documentation. When the inspectors arrived, our team was ready. We passed with minimal citations and had our first CAR-T patient scheduled within weeks of accreditation.]"

— [TITLE], [INSTITUTION NAME]

Ongoing Relationship

[CLIENT] retained IHS for [Annual Report preparation at Year 1 anniversary / Year 3 renewal preparation / ongoing QMP execution support]. [Additional context if applicable.]

Key Takeaways for Cellular Therapy Program Directors

1. Build the Crosswalk on Day 1. The Crosswalk is the central document FACT reviews before scheduling an inspection. Programs that defer Crosswalk development to the second half of the engagement run out of time. IHS begins Crosswalk construction at engagement inception.
2. Written agreements with manufacturers are non-negotiable. FACT consistently cites programs that administer commercial CAR-T products without formal written agreements specifying manufacturer vs. site responsibilities. Execute these agreements before the desk review phase.
3. Execute the QMP — don't just write it. A QMP that exists on paper but shows no evidence of management reviews, quality indicator tracking, or corrective action is the most common single FACT citation. IHS implements QMP execution systems that generate the required activity records from Day 1.
4. Community programs can compete. FACT's Community IEC Standards are designed for programs without academic transplant center infrastructure. The gap between where a community oncology center starts and what FACT requires is bridgeable — IHS has done it.

Building a CAR-T Program or Updating for the 9th Edition?

IHS provides full-cycle FACT consulting for both new programs and existing programs transitioning to the 9th Edition — from eligibility assessment through Crosswalk development, mock inspection, and post-accreditation annual reporting.