Downtime

By A

1. CYTOGENETICS + FISH · DOWNTIME PLAN

LIS Downtime for Cytogenetics and FISH

Stabilize samples, name the exceptions, reconcile cleanly with SoftGenomics (SCC). Staggered rollout: Phase 0 paper, Phase 1 accessioning station, Phase 2 department stations.

2. 02 / THE CORE RULE

Downtime replaces the tile, not the bench

Stays the same

Every bench step follows standard SoftGenomics SOPs Same reagents, instruments, QC and timing No downtime-only bench methods

Moves to paper

Only what a tile would document Recorded on the Case Traveler Entered back into SCC when it returns

3. 03 / ROLLOUT AT A GLANCE

Four stages, each one usable on its own

Phase 0 (now)

Paper only: handwritten DT IDs, scannable travelers, event log, req copies

Phase 1

ACC / CLC accession station: scan req, print labels and travelers

Phase 2

Cyto and Cyto-FISH stations print labels; Flow and Mol TBD

Later

SCC downtime mode on our own CPUs, offline fallback CPU

Phase 0 works with no computers at all. Each later phase falls back to the one before it.

4. 04 / PART 1

Phase 0: Paper Only

Handwritten IDs, scannable travelers and a single event log, with no computers needed.

5. 04 / IDENTIFIERS

Three identifiers on everything

Patient name

Full patient name on every tube, aliquot, slide, traveler and log line.

Date of birth

DOB is the second identifier and always travels with the name.

DT ID, the third

Format DT-26-0000123. The handwritten short form is DT-26-123.

Phase 0: handwritten

Written with a VWR marker and covered with clear tape so it stays legible.

Phase 1+: printed

Printed labels carry a DataMatrix that encodes exactly the printed ID, nothing more.

6. 05 / DT ID FAMILY TREE

Every child is parent plus next unused .n

A FISH slide off a cyto pellet continues the series (L3). Numbers are never reused.

7. 06 / STABILIZATION

Three safe points where a case can wait

The only times written on the traveler: when a case is held at A, B or C, and when it restarts.

8. 07 / FISH RULE

No FISH case waits for the LIS

Received before 1:30 PM

Direct harvested the same day Taken to a fixed pellet (point A) Held at -20 °C until restart

Received after 1:30 PM

Direct harvested the next day Normal 1:30 PM cutoff applies Same fixed pellet at point A

STAT and Pediatric

Processed the same day, even after 1:30 PM Keep going through slides, hyb and post-wash??? Hold times recorded on the traveler

9. 08 / EXCEPTIONS

Five things that never wait

Priority cases

STAT, Pediatric and Rush/Acute cases keep moving through every bench step.???

MM CD138+ enrichment

Done on the fresh specimen. The traveler asks for the RoboSep run report or the Manual sep log.

ThermoBrite slides

Slides already on the ThermoBrite are post-washed within the 12-36 h window.

Cyto cultures

Cultures are harvested on schedule, whatever the LIS status.

Director decisions

Add-ons, probe changes, merges and culture flips need a director decision written on the traveler.

10. 09 / PHASE 0 PAPERWORK

Three documents carry the whole case

Case Traveler

One scannable sheet per case: bubbles, comb boxes, A/B/C hold rows and QC rows. Rows that don't apply are greyed out.

QC by initials

Initials on QC rows confirm QC against the TRAVELER REQ copy. Example of greying out: enrichment on a non-MM FISH case.

Downtime Event Log

One line per case per department, each with a NOTE line. The back page holds notes and the internal note.

TRAVELER REQ copy

A copy of the requisition for every department: TRAVELER REQ at top, department top right, date/time bottom right.

11. 10 / PART 2

Phase 1: ACC / CLC Accession Station

Scan the req, confirm it, then print labels, REQ copies and pre-filled travelers.

12. 10 / SIGN IN

Sign in, pick your station

Initials first

Every user enters their initials before anything else on the station.

Pick your station

Choose ACC, Cyto, Cyto-FISH, Flow (TBD) or Mol (TBD).

Logged under you

Everything you do is recorded under your initials for that session.

13. 10 / THE VIRTUAL REQ

The virtual req, built on PDF Forge

1 Scan the req

Scanner, scan folder or upload

2 OCR reads

Check marks and handwriting areas

3 Side by side

Scan beside the virtual req, or underneath

4 Colour key

Yellow OCR, green CLC added, red x removed

5 CLC completes

Types anything OCR missed

14. 10 / REVIEW PANEL

The review panel flags gaps before printing

Errors

Missing patient name, DOB or specimen type Missing tests or collection date Missing physician signature or ICD10 Missing submitting institution

Warnings

More than one specimen type Faint marks or untyped handwriting Pediatric age Received after the 1:30 PM cutoff

Acknowledging

Errors can be acknowledged with initials Acknowledged errors print on the traveler notes The bench follows up from the traveler

15. 10 / PHASE 1 WORKFLOW

Five steps from req to department

1 Req

Scan and confirm the req; DT ID assigned

2 Tube labels

Check labels: Zebra ZD621, 2 x 0.5 in, DataMatrix

3 Documents

Check TRAVELER REQ copies and pre-filled travelers

4 Yes, proceed

Only now do labels and documents print

5 Dispatch

Each department gets its traveler and REQ copy

16. 11 / AUDIT TRAIL

Every action is logged

Sign in and scans

Every sign-in and every scan is recorded with time and initials.

OCR corrections

Each correction keeps what OCR read and what the CLC changed it to.

Acknowledgements

Acknowledged errors and every confirmation are logged with initials.

Prints and dispatch

Every print and every dispatch per department is logged with time and initials.

One log per day

A single audit log per day, viewable on every station.

17. 12 / PART 3

Phase 2: Department Stations

Each department prints its own aliquot and slide labels on demand.

18. 12 / CYTO-FISH STATION

Cyto-FISH slide labels in eight steps

19. 12 / PHASE 2

Cyto next; Flow and Mol designed with teams

Cyto station

Prints culture slide labels H1, H2, with a backup star.

Flow and Molecular

Placeholders today that show the dispatched case list. We design each station with the team.

Aliquot labels at ACC

Already print in Phase 1 when we know another department needs one: parent plus next unused .n.

Aliquot labels follow the DT ID family tree rule in every phase.

20. 13 / PART 4

Later

Automatic reconciliation and SCC downtime mode on our own lab CPUs.

21. 13 / WHERE WE ARE HEADING

Less re-entry, no single point of failure

Automatic reconciliation

Scanned travelers reconcile automatically against SCC and write the downtime internal note.

Shared case list

Every station sees the same case list, so hand-offs show up everywhere at once.

SCC downtime mode

Runs on our own lab CPUs and network, independent of the main LIS.

Offline fallback CPU

A dedicated CPU keeps working with no network, then syncs back to SCC.

22. 13 / BACK TO NORMAL

Reconcile oldest first, then audit

Accession

CLC accessions each DT case and gets an HLID

Enter tiles

Techs push travelers through the tiles, oldest first

Relabel

HLID labels applied

Retire DT ID

Traveler records the step the DT ID retired after

Document

Internal note plus scanned traveler on the case

Audit

Supervisor audits the event log

Later: scanned travelers reconcile automatically against SCC and write the downtime internal note.

23. 14 / THE ASK

What we need from each group

Directors

Approve hold limits, the same-letter culture rule and the STAT Metafer exception.

CLC / ACC

Own the DT number log and label stock, and test the Phase 1 station.

IT / SCC superuser

Set up the Zebra ZD621, document scanner and regular printer on the ACC PC. Define how scanned travelers attach in SCC.

QM

Map CAP checklist items, set record retention and schedule the annual downtime drill.

24. Approve the plan and schedule the Phase 0 SOPs & Phase 1 test

Send owner names and sign-off for your group's items, then we book a Phase 1 station test and the first downtime drill.