mary butler-mount sinai jan 08-21/06 butler_july 16/final p-exhibits... · same day. the larger...

CIHRT Exhibit P-1848

Mary Butler - Mount Sinai Jan 08-21/06

The purpose ofmy visit to Mount Sinai was three-fold:

• Fixation protocol• QA and Documentation activities for Immunohistochemistry

and routine where time permits• Lines ofCommunication with key pathologists.

The fixation at Mount Sinai are outlined in a manual and practicedas follows;

All specimens were delivered to the Receiving Lab ofPathologyby porters. They were entered into the system and grossed thesame day. The larger specimens were opened and left overnight tofix for Grossing Rounds the next day. The large cases were notopened immediately upon receipt, they were left until someonewas available to handle.

All specimens were to be placed in appropriate fixative, preferably100/0 buffered formalin unless otherwise specified, all specimensreceived fresh or in a fixative other than 10% formalin should beclearly labeled as such.

The QA and Documentation Activities for Immunohistochemistryand Routine Lab are outlined in a manual and practiced as follows:

All sections of the department must have procedure manuals andAll staff is expected to read and sign offto verify an understandingofthe purpose, policies and procedures ofthe Pathology Lab.

Three Manuals should be developed:

One for Grossing (specimen entry, statement for grossing ofalltissues, processing and pathological procedures required)


All Antibodies/Ancillary products must be documented andassessed for validation.

3. Antibody Technical Information for all antibodies willinclude Source, Lot, Subclass, Form, Storage Conditions andOptimized Staining Conditions.4. Antibody/Ancillary Product Record will include pertinentinformation such as date received, manufacture and expiry date.(Fridge)5. Verified Protocol Chart includes the staining protocol withpathologist sign -of~ the Antibody Data Sheet and the AntibodyTechnical Information Chart.

All control tissues must be validated/documented.

6. Control Documentation will include verification ofpositively/negativity ofcontrols and signed-off7. Record ofQuality issues with Immunohistochemical StainingTo include date ofoccurrence, issue, specimen, correctiveaction and date completed.8. Tissue Control Bank offers the pathologist the ability todocument tissues that are positive for specific antibodies andimmunoflorescence.

The lines ofcommunication with key pathologists are accessedthrough a pathologist designate in charge of theImmunohistochemistry lab. The technologists has the freedom andability to consult with a subspecialty pathologist about a specificantibody but the designate pathologist in charge will make the finaldecision on all issues.


One for the main Body ofthe lab including processing, labeling,embedding, sectioning, staining including H&E, cover slipping,quality control, corrective action with documentation andadministrative policies.

One for Immunohistochemistry Lab, which should contain thefollowing:

• General Procedures• Policy on the use ofAntibodies and Reagents• Principles ofImmunohistochemistry• Immunohistochemistry Techniques• Immunohistochemistry Staining• Imunofluorescence• Reagent Preparation• Health and Safety• Quality Control• Document Control

All mechanical equipment must be checked and documenteddaily.

The following Charts are being created:

1. Daily temperature chart will include the water baths, oven,refrigerators, cryostat, and ultra-low freezer with applicablereference ranges.2. pH Standardization chart will include the standards for QCcheck the deionized water and buffer solutions.


Document Control, Immunohistopathology LaboratoryPATHOLOGY AND LABORATORY MEDICINE

Mount Sinai Hospital, Toronto, Canada M5G 1X5

ANCILLARY PRODUCTS PREPARED IN-HOUSEAcceptability is dependant upon the item.Buffers - pHHaematoxylin - nuclear stainingPepsin - IHC staining

ITEM Date Date Acceptable MLT DatePreDared ODened Initials Checked

.

Form IHC-19

U:\My Documents\IHC Manual 2005\SOP11documentcontrol.docVersion 4

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IMMUNOFLUORESCENCE RENAL WORKSHEET

Patient Name:

MRN#:

Pathologist:

Provisional Diagnosis:

Gross Description:

Surgical Number:

Block Number:

Date Received:

Condition of tissue when received:Please check appropriate box

( ) Specimen kept moist in a closed container( ) Specimen is totally immersed in saline( ) Specimen is totally immersed in Michel's Transport Media( ) Specimen is received dry( ) Other: _

Formalin fixed tissue available for paraffin processing( ) Yes( ) No

Immunofluorescence Stains requested:Anti-lgG, Anti-lgA, Anti-lgM, Anti-C3, Anti-C4, Anti-C1 q, Anti-Kappa, Anti-Lambda,Anti-Fibrinogen, Anti-Albumin

Date of Staining: _ #Patient Stained Slides: _

Slide #Anti- IgG IgA IgM C3 C4 C1q K L Fib Alb Neg

PatientTissue

PositiveControl NA

Conclusion:

Form IHC- 4

U:\My Documents\lHC Manual 2005\SOP11 documentcontrol.docVersion 4

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Immunohistochemistry Laboratory: Temperature ChartH20-bath: filled with DH20 set at 43°C; Acceptable between 40 to 47° CDH20: Indicator light at Point of use - GreenRefrigerators A & B: both set at 5°C; acceptable between 2 to 8° CIncubator Ovens A & B: both set at 37° C; acceptable between 32 to 42° CSlide warmer: set at 65° C; acceptable between 60 to 70° CRevco Freezer #80: set at -70° C; acceptable between -50 to -90° COrtho Stainplate: set at 37° C; acceptable between 35 to 38° C

H2O DH20 Refrigerator Oven Slide Deep Stain Date MLT

bath Warmer Freezer Plate Initials

Pt of A 8 A B #80 A Buse

Year: 2005Form IHC-S

Reviewed by: Date:

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Document Control, Immunohistopathology LaboratoryPATHOLOGY AND LASORATORY MEDICINE


IMMUNOFLUORSCENCE REQUESTS

Year:2005

Date Surgical Patient Name Pathologist Date CommentsReceived Number Stained

Form IHe- 11


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DETECTION SYSTEMSUSA- Ultra Streptavidin Detection SystemUV - UltraVision LP Value Detection System

Acceptable Staining - positive staining of known primary anitseraU bl S ... f k . .naccepta e taming - Incorrect stamina 0 nown onmary antiseraLOT Expiry Date Date Acceptable MLT DateNumber Date Received Opened Initials Checked

Form IHC-13


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ANTIBODY DILUTING BUFFER

Acceptable pH: 7.4 - 7.6

LOT Expiry Date Date Acceptable MLT DateNumber Date Received Ooened Initials Checked

Form IHe-f8

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Document Control, lmmunohistopathology LaboratoryPATHOLOGY AND LABORATORY MEDICINE


ANTIBODY TECHNICAL INFORMATION

Antibody: _ Clone.,. _

Source: Mouse Monoclonal (

Manufacturer:

Lot:

Rabbit Polyclonal (

CAT. No.:

Expiry Date:

Others: _

Supplier:

Isotype: Total or Ig Concentration: Negative Dilution:

Form: Concentrated Solution ( ) Lyophilized Power ( Prediluted Solution (

Storage Conditions: Refrigerator, 4-8 °C

Optimized Staining Conditions:

Deep Freezer, - 70°C (

Method: (I

) ABC-Elite (Vector Labs. Inc. () USA (Signet labs. Inc.) (

) UV (Ultra Vision)) DlF (Direct Immunofluorescence)

Pretreatment Testings:

Pretreatment D;\\)t-Iom Re9UffS" Selection

MAR -Citrate\ '50 1'100 1'.).00 l'IOt)ce:..\ .

~~ - EDTA orf-C TAI5 HCL-Pepsin

Ie; eng:. I'IlIJL-Plorcr.\'( ;::"Others

Done By:

1;\\.-,/1">1'<",1-Comments:

Recommended Positive Control:

Initial Date of Use: _

Retirement Date: _Form IHC-2

Date:

Reason:

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RECORD OF QUALITY ISSUES WITH IMMUNOHISTOCHEMICAL STAININGDATE OF SPECIMEN ISSUE PROBABLE CORRECTIVE DATE

OCCURRENCE NUMBER CAUSE ACTION COMPLETED

Form IHC-7


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CIHRT Exhibit P-1848 Document Control, Immunohistopathology Laboratory

PATHOLOGY AND LABORATORY MEDICINEMount Sinai Hospital, Toronto, Canada M5G 1X5

DAILY IMMUNOPATHOLOGY WORKSHEETDATE: -----------RUN # 2 RUN # 3

ABRUN # 1

# 51 AB # 81 AB # SidesRUN#4

AB # 81

NON-PT WKLD# Cases ReQSolPrepTime#ControlsCut#ControlsRunFreeTextLabel


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