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Leica Biosystems CEREBRO automated sample tracking

Paul Williams
15 May, 2015  

As an adjunct to Lean working, CEREBRO specimen tracking provides assurances of enhanced patient safety and improved efficiency throughout the laboratory workflow in a large UK hospital Trust

Paul Williams MSc CSc FIBMS

Head Biomedical Scientist Cellular Pathology,

East Kent Hospitals University NHS Foundation Trust, UK

East Kent Hospitals University NHS Foundation Trust (EKHUNFT) is one of the country’s largest NHS Hospital Trusts, serving a population of 759,000 comprising five hospital sites: Buckland Hospital, Dover; Kent and Canterbury Hospital, Dover; Queen Elizabeth The Queen Mother Hospital, Canterbury; Royal Victoria Hospital, Margate; Folkestone and the William Harvey Hospital, Ashford. 

The Cellular Pathology department provides a centralised service for the population of East Kent located at the William Harvey Hospital, Ashford. The laboratory provides a routine histopathology service and Tables 1 and 2 show average weekly slide production and annual workload, respectively.

To maintain and keep up with this growing workload (6% per annum), we apply Lean principles and embrace modern technology wherever possible to provide a safe and efficient service, which includes digital voice recording, speech recognition and specimen tracking.

Histology remains traditionally a collection of predominantly manual processes easily divided into definable and auditable stages. Prior to CEREBRO specimen tracking technology introduction, we were reliant upon a combination of laboratory information system (LIS)-generated and manual data collection throughout the workflow, which was often incomplete or missing and of unreliable quality, making workflow analysis difficult and often of limited value. LIS for cellular pathology are usually based upon Biochemistry programs, lacking sufficient data fields necessary to monitor the histology workflow accurately. 

After an initial six-month pilot in 2013 with the Leica Biosystems CEREBRO specimen tracking solution with 2D barcode technology,1 we fully implemented CEREBRO in the summer of 2014 (Figures 1–4). The CEREBRO pilot had proven it was able to significantly improve patient safety and facilitate the management of the workflow with effective monitoring of each part of the process. 

Implementation

Any change to established methodologies and processes usually meets with an element of resistance, but staff accepted this technology very quickly. Staff were already engaged in continuing change as a result of previous Lean projects to improve workflow. 

There were several key stages to the configuration process:

  1. Change existing pot and request form 1D barcode label printing to 2D barcode. The 2D barcode would then be used for the specimen pots, request form, cassettes, slide labels and User ID labels throughout the workflow
  2. Configure the system including cassette panels. This enabled us to default specific cassettes to specific tissue types codes, for example, fine mesh Leica ActivFlo cassettes were associated with biopsies up to 2mm diameter, such as endoscopic biopsies. The same code used would dictate the slide labels defaulted at microtomy. In the case of a gastric biopsy this would be a label for a slide with three levels, a Giemsa label and an Alcian blue/PAS stain label.
  3. Slide panels from the LIS and slide types were agreed and configured on CEREBRO
  4. LIS Test codes had to be associated with slide types, for example, immunocytochemistry tests had to be associated with charged slides and the Leica Biosystems BOND immunostainer platforms
  5. Defined tissue groups. All tissues were either Biopsy (Bx), Resection or Routine (Rx) associated with the LIS Tissue codes for example, GASB would be a Bx, ALLMR a resection and SKIC would be Rx
  6. Tissue processing schedules (see Table 3)
  7. Pathologists and grossing users.
  8. Predefined notes agreed and configured for specific clients (Table  4)
  9. Case types, for example, PN Clinical Cytology, PH Histology
  10. Procedure descriptions such as, for example, B for biopsy, D for decal, FS for frozen section etc.
  11. Tissue descriptions, for example, GASB Gastric biopsy
  12. Interfaced devices such as the BOND III immunoplatforms
  13. Container categories (see Table 5)
  14. Location categories.

Patient safety

Staff could see the clear advantages of replacing ‘eyeball checking’ of unique patient and specimen identifiers with the barcode technology.1

Staff felt reassured that the barcode scanning at each part of the process gave confidence of accuracy of patient and specimen identifier quality cross checks and therefore patient safety. Our experience pre-CEREBRO had found that the majority of errors occur in the pre-analytical phase3 (see Table 6), such as accessioning, grossing, embedding, microtomy and case assembly. Such errors occurred in approximately  0.25% of cases.2

Mismatched specimens could potentially pass through the workflow unnoticed with a risk of a specimen being processed and reported for the wrong patient resulting in misdiagnosis. CEREBRO provides a robust system1 that tracks and verifies the identity of every specimen at every point of the workflow. Nothing is left to chance, virtually eliminating human identification errors and includes checks to ensure any potential problem is identified before there is a risk to patient safety. Six months into the full implementation, the pre-analytical mislabelling errors have already reduced to 0.12%. 

Human errors still occur and are related to staff not following correct CEREBRO checking protocols. Further reduction in mislabeling errors will occur as we re-enforce protocols through competency checking. 

CEREBRO specimen tracking has clear patient safety advantages as indicated in Table 7. (All processes in red font have a risk of human error). Staff have the ability to scan a barcode and feel confident that identifiers are being compared and matched throughout the process, significantly reducing the need for “eyeball” checking and the subsequent impact on ensuring the correct specimen is for the correct patient.

Improved patient safety due to tracking at each step in sample preparation

Use of barcoding to automate sample tracking has replaced the need for ‘eyeball’ checking

Efficiency of automated sample tracking and enhanced productivity

In addition to patient safety, CEREBRO offers the ability to monitor quality by attaching a note to an individual specimen, cassette or slide at any step of the process. These notes are auditable against an individual and client workstation. In East Kent we are developing key quality indicators to monitor processes within the laboratory using the audit trail of notes posted. Using CEREBRO’s ability to date and time stamp every part of the process and identify the client and individual user it is possible to record and therefore count per individual the various quality issues identified within Table 4. We will be able to produce quality indices from this data and accurate staff performance profiles that will assist in managing the performance of individual members of staff, offering training support where needed or process changes to continually improve the quality of the work we do.

For example, a member of staff who routinely cuts 20 routine sections per hour but has on average three slides rejected for every 20 blocks cut. This would produce a rejection rate of (number of Blocks rejected/total blocks cut) x 100 = (3/20) x 100 = 15%

This simple calculation will be applied to the different quality issues within the QC category listed in Table 4 for the sectioning client. This will produce a competency profile for each microtomist and the laboratory as a whole with indices for quality improvement. The same approach will be applied to other parts of the process such as embedding.

CEREBRO specimen tracking has resulted in efficiencies is specific areas as shown in Table 8. There will be continuing efficiency improvements arising from an improved understanding of the workflow using the data provided by the CEREBRO dashboard to continuously improve the workflow. 

There are some activities, such as Pathologists scanning cases to themselves, that have a small negative effect on time saved, but the ability to track who has what case has reduced interruptions to reporting when laboratory staff have to locate cases for multidisciplinary team meetings. 

Efficiency is also enhanced by CEREBRO’s ability to produce exception reports that can list specimens that are going to breach set turnaround times at different stages of the process. These include: 

  • Specimens about to breach laboratory turnaround times
  • Specimen about to breach reporting turnaround times
  • Cassettes awaiting processing
  • Cassettes ready for processing
  • Cassettes in processing
  • Cassettes ready for embedding
  • Blocks ready for first sectioning
  • Slides in the Distribution centre
  • Cassettes for extra work
  • Specimens ready.

We are able to minimise breaches to turnaround times by using these data to prioritise cases.

Risk mitigation and removal of human error 

Pre-CEREBRO specimen tracking system errors 

  • Grossing – eyeball checking pot and request form unique identifiers match
  • Tissue processing – checking specimens are on tissue processor and correct processing protocol
  • Embedding – specific instructions for embedding require referral to a list generated at grossing
  • Sectioning – incorrectly labelled slide used with wrong specimen number
  • Case assembly – requires two people; possible to submit incomplete cases as reliant upon matching manually recorded information regarding numbers of blocks and pieces of tissue per slide with recorded information provided at cut up on the request form
  • Send out – incomplete cases distributed with slides missing.

Impact of CEREBRO specimen tracking 

  • Scan pot and form barcodes to confirm match much faster than manual and very accurate as difficult to mismatch. CEREBRO will generate an audible alarm with mismatch directing the member of staff that there is a problem with choice of tissue process. Tissue types have default processing schedule set
  • Record of which tissue processor/protocol and when. Processing protocol is determined at grossing, if cassette scanned into incorrect processing basket CEREBRO will generate an audible alarm directing the operator to the mismatch
  • Logs of who embedded and when and specific instructions are noted on the screen at cut up for embedding. This ensures embedding staff have all the information needed to embed accurately and safely
  • Correct slide label always printed at the microtome for the cassette being sectioned
  • Case assembly and send out simplified ensuring case complete before distribution.

Errors only occur when staff do not follow the correct procedure; this is audited by regular competency assessments.

Conclusions

CEREBRO specimen tracking has provided a safe mechanism with the use of 2D barcodes for ensuring the specimen and patient identifiers match throughout the journey of a patient’s specimen(s) from receipt, to diagnosis, to archive. As users have to log into each client with a unique access code, and all activity is time- and date-stamped with a complete audit trail, accurate individual and laboratory performance can be measured using the real-time tracking tools and dashboards. In addition, quality improvements can be assessed for individuals and for the laboratory overall. 

As an adjunct to Lean working, replacing manual and paper-based systems, CEREBRO specimen tracking has provided assurances of enhanced patient safety compared with previous manual systems as well as releasing some efficiency throughout the process flow. This provides a high level of confidence that the slides the Pathologists are reporting and requesting extra tests on are for the correct patient.

References

  1. Rasanen M. Leica Microsystems 03 June 2011. Specimen tracking: Helping prevent misdiagnosis.
  2. Pantanowitz L, Mackinnon AC Jr, Sinard JH. Tracking in anatomic pathology. Arch Pathol Lab Med 2013;137:1798–810. 
  3. Layfield LJ, Anderson GM. Specimen labelling errors in surgical pathology: an 18-month experience. Am J Clin Pathol 2010;134(3):466–70.