1. Extraneous Tissue in Pathology Failure Modes Effect Analysis Dr Kathy Chorneyko Corinne Fletcher BSc. PA Dr. A. O’Meara

2. Failure Mode and Effects Analysis (FMEA)

4. Specime n receivin g Accessio ning Grossing Processi ng Embedd ing Microto me/ Slide Preparat ion Slide Staining / Cover slipping Block checkin g/ QA Patholo gist review/ final diagnosi s 1) Requisition / labels from procedure missing 2) Incorrect requisition 3) Incorrect specimen labels 4) Incorrect specimen container matched with incorrect requisition 5) Similar specimens (type, patient name) received sequentially 11) Confirm requisition and specimen labels match 12) Confirm cassettes match surgical # on container and requisition 13) Contaminated equipment/ tools (as in #18) 14) Contaminated grossing table/ surface 15) Contaminated gloves 16) Similar specimens grossed sequentially 17) Suction pipette used for more than one case 18) Equipment not properly cleaned between cases 19) Contaminated ink 20) Contaminated sponges 21) Contaminated pipettes 22) Contaminated lens paper 23) More than one specimen container open on gross table at same time 24) # pieces of tissue in each cassette recorded incorrectly 25) Contaminated block rack prior to processing 26) Dictation error- dictation lost 27) Dictation error- incorrectly transcribed 28) Processor contamination with friable specimen 29) Contaminated processor solutions 33) Contaminated microtome blade 34) Contaminated brushes 35) Particulate in air contaminates tools/workstation 36) Contaminated water baths 37) Contaminated glass slides 38) Hands/ gloves of histotechnologist contaminated 39) Contaminated solutions/ stains 40) Contaminated xylene solution (automatic cover slipper) 41) Extraneous tissue missed when slide is block-checked 42) Extraneous tissue noted when slide is block- checked, but is incompletely removed from the slide 43) Pathologist misses extraneous tissue on slide 44) Pathologist notes extraneous tissue on slide but does not take correct measures to trace its origin 6) Specimen mix- up 7) Incorrect surgical #/ labels assigned to specimen 8) Incorrect surgical pathology # written on lid, side of container or requisition 9) Incorrect surgical pathology # hand-written on cassettes 10) Incorrect specimen type written on side of cassette 30) Contaminated wax 31) Contaminated metal blocks 32) Embedder’s tools/ hands/ gloves/ work surface contaminated Process Map- Risk of Extraneous Tissue in Anatomic Pathology Specimens at BCHS

5. Key Process Step or Input Potential Failure Mode Potential Failure EffectsPotential CausesCurrent Controls Actions Recommended Resp.Actions Taken What is the Process Step or Input? In what ways can the Process Step or Input fail? What is the impact on the Key Output Variables once it fails (Patient or internal requirements)? How Severe is the effect to the patient? What causes the Key Input to go wrong? How often does cause or FM occur ? What are the existing controls and procedures that prevent either the Cause or the Failure Mode? How well can you detect the Cause or the Failure Mode? Risk Priority #: X/125 What are the actions for reducing the occurrence of the cause, or improving detection? Who is Responsible for the recommended action? Note the actions taken. Include dates of completion. 16) Similar specimens grossed sequentially Extraneous tissue gets into cassette but not picked up since it is the same type of specimen Major misdiagnosis opportunity leading to harm / death 4Holiday times, slow downs when limited variability of cases1 PA/MLT trained to stagger grossing of similar specimens 520 Notify pathologists, leave extra space in rack for processing, techs who are embedding/cutting made aware, ink if possible, use vegtable matter MLT, PA, MLA, Pathologgists PA, MLT to develp process ot have organic material on hand for occassions when there are insufficient specimens to separate similar types. Completed April 2015. 41520

6. Recent case – liver biopsy

7. Number one priority To ensure that the tissue is processed to the highest standards with no extraneous tissue

8. Basics that are already established Ensure the equipment is cleaned in between in case (forceps, scalpel) Gloves are changed frequently during the grossing of smalls and after each large case Only one specimen is permitted on the grossing station at a time Friable specimens permitted extra fixation time Solutions in the tissue processor changed frequently

9. Changes implemented after a period of monitoring How could we remove any extraneous tissue that was within our control – Single use items – Reservoirs – Traceability – Specimen limitations

10. Single use items All specimens less then 0.5cm use a single use pipette – This ensures no transfer from one specimen to the next, even after cleaning – All critical tissue less then 0.3cm wrap in lens paper (example all lung and liver biopsies)

11. Formalin Reservoirs Flecks of material and excess ink are transferred into the chamber while awaiting to be loaded into the tissue processor for the day

12. Microscopically cellular material found: Change the reservoir daily

13. Embedding chamber reservoirs Once again flecks of material become detached during routine processing on the processor, some material in found in the embedding chamber reservoir

14. Microscopically cellular material found: Change wax frequently

15. Traceability We embed all in numerical order and all is signed off by the tech with the time. If transfer does occur able to see what specimen was embedded directly before to determine if there is a correlation with the extraneous tissue found.

16. For example a colon with flecks of placenta, would be able to see from embedding sheet that the colon was next to the placenta in the rack and was embedding directly after

17. For example a portion of lung tissue has been identified in a liver biopsy From the embedding sheet we were able to determine that the liver was embedded directly following the lung biopsy and thus the extraneous tissue was a result from the embedder not cleaning tools properly

18. Specimen limitations At normal and high peak time no problem to accession similar specimens with opposing tissue in between At low volume times, the OR and AC closure during Christmas and new years, may only get similar specimens (appendix) and have to process sequentially

19. Place a piece of vegetable matter in between these cassettes on the embedding rack This give the technologist a visual cue to be aware that there is two similar specimens back to back Also the vegetable matter may catch or contain any friable material that detaches during processing Notify pathologist of two similar specimens sequentially

20. Thank You Any questions?