An Innovative Approach to Removing Formalin from our

Operating Rooms

Pathology Team- Diagnostic Services of ManitobaDr. Gabor Fischer, Medical Director of Pathology at DSMLisa Manning MLT, B.Sc., Technical Director of Pathology at DSM

Objectives

Results of a DSM Quality Improvement Project

Can we eliminate a toxic agent used for transport of surgical samples

AND

improve the diagnostic quality at the same time?

Brief overview of Quality Assurance in Pathology

Role of Pathology

Pathology and laboratory: source of 70% of all data in medical records

Huge impact on therapeutic decisions

Main diagnostic consultation: surgical pathology

Route of Tissue Sample from OR to Diagnosis

1. OPERATING ROOM↓

2. TRANSPORT↓

3. PATHOLOGY LAB↓

4. PROCESSING ↓

5. PATHOLOGIST

Quality Improvement Projects

Challenge the old ways

cost effective? productive or efficient enough?

Test a new approach implement an innovation

DSM quality improvement project

Can we eliminate a toxic agent (formalin) from certain steps of the tissue preparation?

The Role of Formalin

Tissue degradation starts quickly

no blood supply

Tissue needs fixative to preserve the cells

formalin added ASAP in the OR

Suboptimal fixation can affect patient care

diagnosis + ancillary studies

cancer treatment (or other diseases)

Surgical sample placed into formalin

Most critical step in patient sample handling

Tissues with Autolysis and Degradation

Delayed Fixation = Impaired Histology

Optimal fixation Delayed fixation

Why do we use formalin for fixation?

Works really well

Prevents tissue dehydration

Antiseptic effect

Penetrates relatively quickly (1cm/24hour)

Preserves morphology

ancillary studies (stains) are possible

Why do we need an alternative?

Cancer Allergy Asthma Eye injury Skin injury

Why do we need an alternative?

Exposure is unavoidable

open or leaking containers, spilling and fumes

OR staff, pathologists, residents and pathologist assistants

Formalin filled containers can be heavy

20:1 ratio may be difficult to achieve

Freezing /overheating during transport

Ideal Formalin to Tissue Ratio = 20:1

Why do we need an alternative?

Route of patient sample – 4 out of 5 steps involves formalin

An alternative fixation technique in OR would dramatically decrease formalin exposure

would eliminate it in steps #1&2

would minimize it in step#3

1. OR →

Formalin

2. Transport

→

Formalin

3. Pathology Lab

→

Formalin

4. Processing →Formalin

5. Pathologist

Is there an alternative?

Vacuum Sealing of Tissue Samples

Vacuum Sealing of Tissue Samples

Similar to packaging of meat and cold cuts

Vacuum + cold

Vacuum Sealing of Tissue Samples

Simple

Safe

Requires only a short training

No chemicals necessary

Package is light

Potentials /Goals of the Study

Formalin free environment for sample transfer from OR to Pathology Lab

Improved quality of diagnostic workAvoiding suboptimal fixation

Improved quality of working conditions for staff Reduced exposure to a toxic material

Decreased weight of specimen containers

Study Design

12 different tissue types surgical pathology and autopsy

examined by both methods (vacuum vs. formalin)

All samples were divided into 4 piecestwo pieces - vacuum sealed, stored at 40 C

two pieces - buffered formalin (fixed for 24-72 hours)

Quality of tissue morphology was compared

Study Design – Tissue Types

Placenta

Lung

Kidney

Lymph node

Breast

Gastrointestinal: small bowel + colon

Gynecologic: uterus + cervix

Genitourinary: prostate and testis

Liver

Results

Breast skin - 24 hours formalin and vacuum, H&E stains

Formalin Vacuum

Results

Kidney - 24 hours formalin and vacuum, H&E stains

Formalin Vacuum

Results

Breast - CK7 immunostain, 72 hours formalin and vacuum

Formalin Vacuum

Results

Colon- CDX2 immunostain, 24 hours formalin and vacuum

Formalin Vacuum

Results

Breast - p63 immunostain, 24 hours formalin and vacuum

Formalin Vacuum

Results

Gross tissue - color and consistency

No difference

Microscopic morphology - routine

No difference

When morphology is suboptimal (autolysis), it is equally present in both methods

Immunohistochemical stains (12)

No difference

Conclusions from Project

Vacuum sealing can be an alternative to formalin

Huge potential in improving the working environment

May have a role beyond surgical pathology

remote autopsies or catastrophic scenarios

would decrease health risks for morgue staff

Quality of diagnostic work may be improved

problems related to suboptimal fixation are eliminated

Other ways to Assure Quality in Pathology

Many other processes beyond projects

Pre-analytical

Analytical

Post- analytical

Public focus is on analytical

Assure Quality in Diagnostic Interpretation

Second opinions, consultations

Correlations

Audits, reviews

Preformed reports (synoptics)

Checklists

The Power of Checklists

1935, Dayton Ohio

Flight competition for airplane manufacturers

US Army Air Corps` next generation bomber

Boeing was the absolute favourite

Model 299 – “flying fortress”

could fly faster and twice as far as competitors

could carry 5 times as many bombs

The Power of Checklists

Investigation revealed no mechanical problem

Pilot error – too much of an airplane for a man to fly

complexity was overwhelming

too many things to control

Response: pilot checklist was created for Model 299

Step by step, from take-off to landing

Result: 18 million miles in the air with no accident

13,000 aircraft was sold

decisive air advantege in Second World War

Aviation Checklist

Surgical Safety Checklist

R

Surgical Pathology Checklist

Assure Quality in Diagnostic Interpretation

Confirmatory second interpretations

First pathologist (captain) – diagnosis

Colleague (co-pilot) - confirmation

mandatory for certain malignant diagnoses

These safety checks are extremely helpful

Most of the time...

To Err is Human (US Institute of Medicine, 1999)

Paralells: aviation and medicine

Aviation Diagnostic Medicine

Safety Checklists Safety Checklists

Redundancy

Double checks(captain+ first officer)

Redundancy

Double checks(diagnosis by 2 people)

Strict regulations

Federal Aviation Agency

Strict regulations

Professional organizations

Comparisons: Aviation and Medicine

The mortality of hospital related injuries per year in US (180,000) is equivalent of 3 jumbo jet crashes every 2 days throughout the year. (LL. Leape, MD, Department of Health Policy and Management, Harvard School of Public Health, 1994)

Cockpit

Pathology Cockpit

Quality Assurence in Pathology

Lot of progress in last years

Accreditations

Strict rules for recruitments

Mandatory reviews at the end of probation

Competency assessments

Peformance evaluations

Feedback on quality

Lean projects

References

The Checklist Manifesto. How to get things right. Atul Gawande. Published by MetroplitanBooks, 2009, ISBN: 9780805091748.

Error in medicine. LL. Leape. JAMA. 1994 Dec 21;272(23):1851-7.

Validation of vacuum-based refrigerated system for biobanking tissue preservation: analysis of cellular morphology, protein stability, and RNA quality. Condelli V et al. Biopreserv Biobank. 2014 Feb;12(1):35-45.

Vacuum sealing and cooling as methods to preserve surgical specimens. Kristensen T et al. Appl Immunohistochem Mol Morphol. 2011 Oct;19(5):460-9.

Vacuum-based preservation of surgical specimens: an environmentally-safe step towards a formalin-free hospital. Di Novi C et al. Sci Total Environ. 2010 Jul 15;408(16):3092-5

Tissue transfer to pathology labs: under vacuum is the safe alternative to formalin. Bussolati G et al. Virchows Arch. 2008 Feb;452(2): 229-31.

Efficient stem cell isolation from under vacuum preserved tissue samples. Moggio A et al. Organogenesis. 2012 Jul-Sep;8(3):71-5.

Acknowledgements:

-Jill MacKenzie

-Dr Raymond Rivera

-Helen Connelly

-Shelley Ganske

-Karen Cormier