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Cheatography

Hospital: Planning the Core Lab Cheat Sheet (DRAFT) by [deleted]

This is a draft cheat sheet. It is a work in progress and is not finished yet.

Introd­uction

A variety of progra­mmatic and design issues can influence the planning of a centra­lized clinical testing — or core — lab. While progra­mmatic issues theore­tically come before design, they are intert­wined. The following categories of planning and design consid­era­tions, all of which are relevant to creating a successful facility solution, are therefore not sequen­tial, even though the first two are likely the initial steps in the process.

The Operat­ional Concept:

Progra­mming the space begins with unders­tanding the staffing model, which includes everything from hours of operation and the work-shift strategy to safety protocols and cleaning proced­ures. Then comes the develo­pment of a logistical plan for sample management along the entire chain of custody control, including receiving, sample login, distri­bution, testing, reporting, freezer or cold-room storage, waste removal and management of consum­ables. Equipm­ent­-re­lated optimi­zation issues like capacity modeling, throughput analysis and backup strategy round out this operat­ional strategy.

Organi­zation of Flows

Applying Lean princi­ples, the team then tackles work cell develo­pment with sample flows and efficient use of equipment and space and evaluates layout opport­unities as well as personnel, equipment, sample and waste flows. Flow analysis is used to confirm contam­ination control, sample integrity and protocols antici­pated. The team looks for opport­unities to prevent contam­ina­tion, process overlaps and bottleneck condit­ions. It also evaluates furnis­hings and equipment arrang­ement (e.g., sample prep and instrument layout) to help optimize work patterns and shared equipment opport­uni­ties. The team considers lab, office and support space adjace­ncies, which are critical for connec­tivity and superv­ision, as well as intera­ction space for coordi­nation between testing groups

Modular Planning for flexib­ility

An open-lab concept allows the greatest flexib­ility of space for future change with functional separa­tions only where required. Within this space, utility distri­bution is planned to allow for open floor plates and flexible connec­tions. The team then establ­ishes a planning grid that allows for adapta­bility in the technology platform, lab automa­tion, and assay and equipment upgrades. Sample prepar­ation, incuba­tion, amplif­ica­tio­n/d­ete­ction and recording stations — which are important to optimize movement between operations — are located within the grid. Additi­onally, servic­eab­ility of equipment and calibr­ation requir­ements (utili­zation logs) are confirmed. Finally, structural loading and vibration criteria, essential for sensitive equipment and robotics, are reviewed.
 

Developing Safety & Contai­nment Strateg

The team determines the biosafety level or potency of compounds and provides safeguards for personnel (e.g., personal protective equipment) and product (e.g., contai­nment device or room), gowning and degowning concepts and isolation requir­ements. It also conducts safety or hazard and operab­ility reviews and confirms intended standard operating proced­ures.

Cross-­Con­tam­ination Control

This involves functional separation of special testing needs; space pressure cascade and relati­onships between adjacent areas; and special proced­ure­/sp­ecial design requir­ements, including those for clean rooms designed to ISO standards, cleanable surfaces, partic­ula­te-free finishes, enviro­nmental monitoring and, potent­ially, high-e­ffi­ciency partic­ulate air filtra­tion. An air-ha­ndling zoning and cleanl­iness strategy will need to be put in place, whether using direct­ional air flows or special spatial monito­ring, when required.

Regulatory impact

Besides typical building codes and standards, these may include Centers for Disease Control and Prevention and World Health Organi­zation guides; Clinical and Laboratory Standards Institute regula­tions; American Society of Heating, Refrig­erating and Air-Co­ndi­tioning Engineers standards; and National Fire Protection Associ­ation standards for flammables and life safety, among others.

Special Systems & Security consid­era­tions

This will involve controlled access, equipment monitoring and alarms, data storage and multiple electronic reporting systems (espec­ially those governing uninte­rru­ptible power supply, valida­tion, redundancy and protection of personal inform­ation) as well as a data backup strategy that is balanced against operat­ional costs.