A Pragmatic Revolution for Histology Laboratories. Start with the end in mind.

Transcription

1 A Pragmatic Revolution for Histology Laboratories Start with the end in mind. 1 Improve diagnostic quality by introducing standardization, automation, and documentation of the pre-analytical step.

2 2 Improve turnaround time by rapid on-demand processing. 3 Improve work environment by leveling the workload and eliminating toxic reagents.

3 First Things First Focus on the pre-analytical steps, where 68% of errors take place* Standardization and documentation of each step is KEY *Plebani M.Carraro P. Mistakes in a stat laboratory: Types and frequency. Clin Chem 1997;42: Be aware of the domino effect! If the first step is incorrect...

4 each step of the sample preparation is compromised Lab Specimen examination SPECIMEN Histoprocessing Lab Staining Embedding/ Sectioning Root Cause Analysis of Surgical Pathology and Cytopathology Identification and Information Defects* Comparison of Deficiency Rates by Defect Type (n=773) Container Requisition # of errors Error Rate # of errors Error Rate Patient Name % % Other Patient ID % % Physician Last Name % % Physician First Initial % % Hospital Name % % Date of Collection % % Time of Collection % % Specimen Description % % *Raab et al. University of Colorado - USCAP 2008 Poster

5 ROSAI AND ACKERMAN S Surgical Pathology Volume 1 Chapter 2 Grossing If the dimensions of the specimen are not recorded, the key section not taken, and the proper special studies not performed at the time of the initial gross examination, the chances of acquiring this information may be lost forever..in many cases, an inadequate gross dissection and sampling will invalidate the miscoscopic interpretation. Today s Fixation/Grossing procedures are 20 th century techniques H&E, HC, IHC, molecular studies are 21st century techniques

6 Focus on Pre-Analytical Steps Needs 1. A chain of custody of specimen from patient to the histology lab. 2. Start of fixation under standardized and documented conditions. Focus on Pre-Analytical Steps Needs 3. Standardization of grossing tools. 4. Control of thickness of each specimen. 5. Processing based on actual maximum thickness of blocks.

7 Milestone s Chain of custody for histological specimens Standardized, Documented Procedures Surgery Transfer Macro Imaging Grossing Standardized Tools Thickness Control Processing Fixation SURGERY TissueSAFE Vacuum Unit Dedicated vacuum unit installed in dirty room adjacent to surgery suite. Elimination of formalin in surgery suite. Hold biospecimens in as fresh conditions

8 SURGERY TissueSAFE Sealing biospecimens under high vacuum in sterilized plastic bags and immediately placing them in a controlled environment (+4 C). TRANSFER The TissueSAFE System Laboratory-grade Cooler Transfer Box

9 TRANSFER The TissueSAFE Chain of Custody RFID Smart Card Time-Temperature Log The TissueSAFE Quality Tissue transfer to pathology labs: under vacuum is the safe alternative to formalin* Adenocarcinoma of the colon. Under vacuum at 4 C for 48h Infiltrating ductal carcinoma of the breast. Under Vacuum at 4 C for 64h Infiltrating ductal carcinoma of the breast. Under Vacuum at 4 C for 64h * Virchows Arch (2008) 452: G. Bussolati : L. Chiusa : A. Cimino : G. D Armento Department of Biomedical Sciences and Human Oncology, University of Turin, Italy

10 TissueSAFE Quality: Molecular Studies Biobanking (A) Frozen immediately after removal (B) Preserved under vacuum at 4 C for 48h GROSSING IMAGING MacroPATH D Macro Digital Imaging System for Documentation of Grossing

11 Creating a Library of Macro Images Sizing

12 Block Key Guidance Full Documentation

13 All macro images plus audio comments available to pathologists at time of signing off. Selected macro images can be added for patient/clinician focused enhanced report. GROSSING TOOLS CutMATE - Standardized DissectionTools Forceps available for mm

14 GROSSING TOOLS ProCUT - Standardized DissectionTools Slicing organs at 4 mm interval. THICKNESS CONTROL CheckLITE Laser-based system for non-contact control of specimen thickness in the cassette. Specimen above preset thickness either re-cut or processed with different protocol.

15 FIXATION Control of Fixation Standardized, well specified and documented protocols for fixation are the key for optimization of A.R. protocols, for more accurate IHC results. ASCO/CAP Recommendation HER2 Results : approximately 20% of current HER2 testing may be inaccurate. Time for tissue acquisition to fixation should be as short as possible Samples should be sliced at 5-10 mm intervals Placed in sufficient volume of neutral buffer formalin Time to fixation and duration of fixation if available should be recorded for each sample. Fixation for fewer than 6 hours or longer than 48 hours is not recommended. ASCO/CAP Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer, Arch Pathol Lab Med-Vol 131, January 2007

16 FIXATION To become a science, fixation must be under the control of the histology laboratory Standardization and documentation of: Dimensions of blocks Specimen/Fixative volume ratio Type of fixative Time of fixation Temperature of fixation Stirring YES/NO FIXATION FixMATE Dedicated unit according to ASCO/CAP 2007 Guidelines for length of fixation 6-48h Microprocessor control of: Temperature Time Stirring Rinsing/Holding Step Download/Logbook for documentation

17 FIXATION FixMATE Specimen arriving on Thursday and Monday is holiday (over 48h)? Set Formalin / Saline cycle. After fixation time is expired. Formalin is drained. Saline solution is pumped in to stop fixation, and preserve specimen. Improve turnaround time by rapid on-demand processing.

18 Do you want a quick result, or the right result? Accuracy and speed of diagnosis CAN BE ACHIEVED with today s technology Today/Tomorrow Needs Improve T.A.T. from days to hours. Reduce patient s stress while waiting for results. Just humanitarian feelings?

19 Radiology March 2009 Radiology March 2009 Conclusion: Uncertainty about the final diagnosis after LCBB is associated with substantial biochemical distress, which may have adverse effects on immune defense and wound healing. Results indicate the need for more rapid communication of biopsy results.

20 PROCESSING Milestone s Tissue Processors Line Process On-demand A pragmatic approach to improve the workflow of the Histology lab PROCESSING Semi-Automatic Multifunctional Line Kos and Histos : Tissue Processing Decalcification Special Stains Antigen Retrieval Rapid Fixation Gross Hardening

21 PROCESSING Automatic Microwave Line Pathos Delta & Pathos Classic High Workload Throughput PATHOS HISTOS KOS Low Low Application Versatility High

22 Rapid Processing: User Experiences Lahey Clinic (Burglington, MA) N 2 Automatic Pathos since 2006 All tissue are processed with the microwave processors Considering the outsource lab, cell blocks, biopsies and surgical cases they process about 34,000 cases a year Many cases have multiple parts In 2008 the total number of blocks was 158,804

23 TAT decreasing by adopting this technology TAT has decreased from 2006 average of 3.13 days to 2.39 days currently These numbers are for all cases including those with special stains/studies They are hoping to decrease overall TAT even further 1.5 days is the goal Stat cases received before 2:00pm are out to the pathologist in about 3 hours and are often signed out the same day Impact on the laboratory workflow and personnel This is the biggest change and has been the most challenging. With more continuous workflow there is no beginning or end. Now it s important to process the specimens as soon as possible and get them to the Histologists. Histology Technicians now embed, cut, and stain throughout the day, the big batch of blocks in the early morning is gone.

24 Impact on the laboratory workflow and personnel Dictation has to be typed as soon as possible and the Pathologists receive and sign cases out all day long. The work comes through the lab smoother and more consistently The pace is more relaxed and staff are more efficient Increase of productivity and rapid diagnosis impact on clinicians and patients in the area It is possible to routinely accommodate requests for sameday diagnosis Clinicians and their patients are receiving their diagnoses faster and therefore the amount of time the patient has to anxiously wait for their result is shorter

25 Processing Workflow 3-6 runs per instrument each day The total number of runs is between 6 and 10 per day If a lot of small biopsies are received throughout the day there are more runs If there a lot of large surgicals and fatty tissues then there will be fewer runs Processing Workflow (unit 1) at about 5am (small biopsies from the night before) - no fixation ( cassettes) (unit 2) by 6am small biopsies - no fixation (20 50 cassettes) (unit 2) by 9am routine 4mm - no fixation ( cassettes) (unit 1) by 10am fatty 4mm is started - with fixation ( cassettes) (unit 2) at 11:30am -12pm small biopsies - with fixation (25 50 cassettes) (unit 2) at 1:30pm routine 4mm with fixation (25 50 cassettes) (unit 1) at 3:30pm routine 4mm with fixation ( cassettes) (unit 2) at 4:30pm small biopsies with fixation ( cassettes) (unit 1) at 7pm routine 4mm with fixation (overnight) ( cassettes) (unit 2) at 7pm fatty 4mm with fixation (overnight) ( cassettes)

26 Holland Hospital (Holland, MI) N 1 Automatic Pathos since 2006 Specimens are picked up in surgery every two hours, couriers drop off specimens throughout day Three processing runs on Pathos during the day: 7:30am, 10:00am, Noon If large cases in morning, can skip 10:00 run to process a longer run at 7:30 One or two overnight runs (Start Delay function) Routine times for H&E slides from Pathos to Pathologist Average histology turnaround time: Approx. 30 blocks/15x10x3mm/no fixation; 2:15 on processor 20 min. embed 30 min. microtomy 45 min. stainer/coverslipper 5 min. scan/check out of Powerpath TOTAL TIME: 3 hours 55 minutes

27 Benefits of adopting rapid processing technology TAT has decreased overall with the addition of barcoding in histology and the use of voice recognition in dictating the gross, microscopic and final diagnoses. Labor has seen a more continuous flow of work throughout the day vs. the old processing method of getting a large batch coming off a traditional processor in the morning and working on it all day long. Our shorter TAT has improved our relationships with the clinicians and in turn with their patients who receive their results quickly and accurately. S.Raffaele (Milan, Italy) Semi- Automated Rapid Microwave Since 2004 From July 2004 Rapid prostate biopsies were performed for Pca detection Biopsies are taken in the early morning and diagnosis is communicated to the patients by the pathologists/urologists in the afternoon

28 Benefits This experience confirms the validity of new automated microwave-vacuum devices to process prostate biopsies in a short time. Milestone s rapid microwave, as well as other rapid processing tools now available, were at least as effective as the traditional processing method and could guarantee a new time effective standard to spare time, costs and stress for the patients. Being a xylene-free method, handling of the specimens is simplified and safer. Milestone s rapid microwave allows a better quality of service with a one-day diagnosis. Achieved results by adopting this technology Allow surgical plan of the day after for admitted BPH pts without previous histology Allow diagnosis and therapy plan in 1 day for outpatients living away Requires organized, dedicated and motivated pathologist

29 22nd CONGRESS OF THE EUROPEAN ASSOCIATION OF UROLOGY MARCH 2007 BERLIN Definitive histopathologic diagnosis on prostate biopsies in 3 hours Best Poster Royal Liverpool Hospital (UK) Reasons to move to rapid processing: Completing the day s work Creation of one-stop clinics Improving patient care Improving renal biopsy turnaround times Reducing turnaround time for all biopsies

30 Achieved results Average turnaround time for all biopsies specimens during trial was 0.92 days Backlog disappeared Staff morale increased significantly by removal of backlog Processing quality never compromised and IHC (ER/PR/HER-2) was not affected Milestone Medical THANK YOU!