A Network Approach to Creation and Maintenance of Standardized Standard Operating Procedures

The Sarah Cannon Blood Cancer Network (SCBCN) consists of 6 programs in the US performing over 850 HSCTs annually. A goal was established to develop a single set of standard operating procedures (SOP) that would support Network members. This standardization project was guided by four principles: Quality, Efficiency, Democracy, and Collaboration.

A BMT physician and Program Quality Manager were established as co-chairs of the SOP Standardization Committee. Each BMT program identified work group representatives from clinical, collection and processing.  Processes were established including identifying the SOP team leads and development teams, collection of more than 300 SOPs from each BMT program, drafting of standardized SOPs, soliciting program input, dispute resolution, and approval. The SOP Review Process was coordinated by a project manager.

The SOP standardization process resulted in the creation of approximately 70 Network SOPs. The project of SOP standardization was started in October of 2011, and the standardized SOPs were made available for local approval and implementation in early 2013. Programs had the freedom to customize the Network SOPs for program-specific needs but were not to remove core content. SOP maintenance including routine review is managed by a continuing Network SOP committee with representation from clinical, collection and processing laboratory staff in each program. This committee meets monthly by conference call and reviews SOPs per an annual review calendar. One SOP is selected each quarter and monitored for “drift” from the Network template SOP. Five of the network programs underwent FACT inspection and found the network SOPs to be helpful in preparing for and passing the inspection.

Network-wide development required resource and time commitment from all programs. A common quality plan helped all institutions meet regulatory requirements and common outcome measures.  Ongoing commitment and review of the SOPs is required to prevent institutional drift and update SOPs to meet any changes in regulatory requirements.