Advancing Cancer Diagnostics
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Setting up a State of the Art Laboratory

By understanding and adopting precess improvement and lean principles, laboratories can achieve more efficient workflows by eliminating steps, reducing waste, and producing higher quality slides more quickly than ever before.

Faster turnaround time

  • eliminating multiple data entry points, paper trails
  • reducing the number of hand offs and decreasing cycle time

Cost reduction

  • through a smarter Inventory Management System (Kanban, FIFO) to manage replenishment cycles and reduce disposal of expired consumables
  • decreased consumable costs through Reagent Management Systems
  • eliminating cost of buying and disposing of hazardous waste (xylene free) and the use of consumables appropriate for the procedure and instrument ( e.g. biopsy cassettes to eliminate the carry over from sponges, ActivFlo cassettes for better fluid exchange)

Safer work environment

  • decreasing repetitive motion steps
  • less exposure to hazardous chemicals (xylene-free work)
  • less stressful work environment will reduce errors and accidents

As with every large-scale project the pre-planning stage is very crucial and in addition to basic decisions about the budget, the architect and the facility, you need to have clarity about the specimen volume and types you will process, the amount and type of equipment to be installed in the laboratory and the number of employees and shifts in order to design or re-design the laboratory in a LEAN fashion.

Regardless of whether you do have an existing blueprint or start with a clean slate, your first step should be drawing a high level process map (Value Stream Map) to identify the process and information flow for all laboratory areas (AP, IHC, Cytology, etc.) This will visualize the basic process flow for each area as well as how you are planning to handle your information flow: ideally paperless with barcoding and specimen tracking through each process step, which will require PC monitors and scanners throughout the laboratory.

Once you have visualized the process flow, take a look at the equipment you are planning to put in the laboratory. Are there instruments that will be shared by laboratory areas? E.g. will the H&E Stainer be used to dehydrate IHC slides as well? The identification of shared equipment will determine where this equipment is situated in the laboratory as it should be accessible from all areas that it will be used for.

With your Value Stream Map in hand which will show you the Takt Time (available work hours / per day divided by customer demand / per day based on your expected specimen volumes) you will know how often you have to sign-out slides in order to meet the customer demand. Be sure to include your growth prediction for the next 3-5 years into the customer demand in order to set the laboratory up for growth. Knowing the Takt Time will then determine how to utilize your equipment (how many processor runs or stainer runs are needed throughout the day) and how many employees you need at what time throughout the day in order to meet customer demand in a timely fashion. Once the number and timing of your staff is known you are able to decide how much equipment will be shared amongst shifts. By now you should have all questions answered in order to start designing the laboratory layout.

Lean Process Flow

As no laboratory blueprint looks the same, the following illustrations are meant to demonstrate the components needed in each area of the laboratory and give helpful hints on how to place them according to a LEAN process flow.

Accessioning area

Every accessioning desk should have a PC with a scanner and a LIS label printer in order to print bar-coded labels for the vials which can then be scanned at grossing if needed. The requisition forms should be scanned into the LIS and placed onto the network (server) to be accessible for the pathologists, transcription and billing if needed.

Accessioning area
Accessioning area

The specimens will then be passed to the grossing area in a container holding the standard batch size, ideally through a pass-through window.

Grossing and processing area

The room contains grossing stations, cassette label printers, specimen storage, processors and flammable cabinets for the bulk reagents.

Grossing and processing area
Grossing and processing area

There should be a clean sink as well as lab coat hangers outside.

The grossing stations are each equipped with a cassette label printer, a PC with monitor, a scanner, a microphone for voice recognition and a digital camera if desired.

Once the specimens have been passed through the window they should be put onto a trolley which will be placed in between the grossing stations.

The PA takes the specimen vial and scans it which generates an automatic printout of the cassettes needed in pre-defined quantities. If the numbers of cassettes printed have to be increased or decreased the PA is able to adjust the quantities immediately in the LIS system, thus reducing the possibility of errors downstream in the process. The grossing is recorded via voice recognition software. The specimens are placed into the color coded cassettes which are placed into the processor racks sitting in a bucket with formalin designated to the rapid processors that they will be placed in. The numerical order within the case is kept.

The rapid processors are utilized several times a day to minimize the batch sizes and achieve continuous workflow.

Embedding and sectioning areas

The embedding and sectioning areas are in very close proximity to each other in order to achieve the concept of one case flow or small batch sizes.

Embedding and sectioning areas
Embedding and sectioning areas

Therefore they should contain the embedding centers, slide labelers, microtomes, water bath, monitors and scanners at each station.

The cassettes that have been processed should be equally distributed amongst all embedding centers. If there are questions at the embedding stage about the case, the cassette can be scanned and the case history can be retrieved from the LIS system.

Once embedded, a complete case or a small predefined batch size will be moved to a microtome station. The embedder should distribute the workload continuously to all microtome stations keeping cases together.

The HistoTech scans the block and the slide labeler automatically prints bar-coded color coded slides according to a pre-defined panel.

The blocks are trimmed and sectioned and put immediately into the H&E stainer rack.

Staining and coverslipping area

This area contains an automated stainer/coverslipper, as well as a sink and the flammable cabinet for the bulk reagents. As soon as a stainer rack is filled with slides the rack is placed into the H&E stainer/coverslipper to achieve continuous flow. Cases are kept together.

Slide sign out and QC area

This area which is located in close proximity to the cover slipper will consist of a microscope for QC, a PC and a scanner. The slides that have been taken off the cover slipper will be placed into slide folders, checked underneath the microscope and then the slides in the folder will be scanned to sign them out within the LIS.

Slide sign out and QC area
Slide sign out and QC area

This should trigger a notification at the pathologist´s PC that there are slides to be read.

The file folders will then be placed in an appropriate location to be picked up by the pathologist.

Ideally the block storage is close to this area as if you process IHC, Special Stains and Re-cuts you will be able to find the blocks you need in this area.