[Histonet] Histonet Digest, Vol 220, Issue 8

Thu Mar 17 17:54:39 CDT 2022

Hello Jayalakshmy,

iPassport is our digital quality management system. It is a commercial product that allows us to collect data, record audits, document Corrective Actions, manage controlled documents (eg manuals), expiry data and verification of antibodies, staff competencies and training and equipment maintenance reports etc in order to aid us in meeting the ISO 15189 standard for laboratory accreditation.

The “History” screen is available on the Bond automated immunostainer.

This is our policy for quality assurance of out-dated antibodies, so the mechanics are our department’s procedure. I did not try to make it generic (too little time to edit ☺ ).

Tony Henwood JP, MSc, BAppSc, GradDipSysAnalys, CT(ASC), FFSc(RCPA) | Principal Scientist; Adjunct Fellow, School of Medicine, University of Western Sydney; Visiting Lecturer, School of Life Sciences, Faculty of Science, University of Technology Sydney | Histopathology
t: (02) 9845 3306 | e: tony.henwood at health.nsw.gov.au<mailto:tony.henwood at health.nsw.gov.au> | w: www.schn.health.nsw.gov.au<http://www.schn.health.nsw.gov.au>
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From: jayalakshmy p.s [mailto:psjayalakshmy at gmail.com]
Sent: Friday, 18 March 2022 12:45 AM
To: Tony Henwood (SCHN) <tony.henwood at health.nsw.gov.au>
Subject: Re: [Histonet] Histonet Digest, Vol 220, Issue 8

Hello Henwood,
Thank you for the reply to my post with elaborate explanation and appropriate references. We doubted about the validity of using after expiry date. We keep onslide controls for every case. So with your suggestion we are confident of using it looking at the control. We, in developing country has not much finance to replenish the reagents past expiry date frequently when it is sparingly used.
Sorry to say that I didnt understand the words ipassport & history screen. Can you elaborate a little more about these terms?
Thanks & Regards
Jayalakshmy

On Thu, Mar 17, 2022, 6:48 AM Tony Henwood (SCHN) <tony.henwood at health.nsw.gov.au<mailto:tony.henwood at health.nsw.gov.au>> wrote:
Hi Jayalakshmy,

This our policy at the Kid's hospital in Sydney:

Validation of Expired Antibodies
Usually when a new concentrated antibody is received it will have an expiry date of around 2 years from receipt but usually we can continue to use antibodies well past this expiry date.

If the antibody continues to stain control sections appropriately, with no loss of sensitivity and no increase in non-specific staining then its use should be continued. If positive control samples are deemed unsatisfactory, even if the antibody is within the manufacturer’s printed expiration date, evaluation of the clinical specimen is aborted and the test deemed invalid. The quality of the primary antibody is therefore not based on an expiration date, but rather on its performance on a case-by-case basis with appropriate positive and negative control samples (1).

Several authors have investigated whether the shelf-life of diagnostic antibodies was longer than the expiry date on the label. They found them to work perfectly on routine histology sections (1-4). Monoclonal antibodies originally supplied as culture supernatants or as ascites (neat or diluted), of all isotypes, as well as all of the polyclonal antibodies, produced satisfactory staining irrespective of their age. Notable exceptions were ammonium-precipitated, IgM or conjugated antibodies.

The policy at CHW is, when an antibody has reached past its expiry date, its control is tested to ensure that there has been no loss of sensitivity in the test. This is now controlled through iPassport, where a task is attached to the antibody requesting validation of control when the antibody is expired. This can be easily done by using the History Screen and looking for use of this antibody within the last two weeks. If results of control are acceptable, another task is instigated for 6 months hence.

For antibody concentrates that are received without an expiry date, a verification is scheduled 12 months after receipt of the antibody.

If an antibody fails to perform to expectations then a Corrective Action Request is instigated in iPassport and appropriate investigation is instituted.

References:
1. Savage, E. C., & DeYoung, B. R. (2010). Antibody Expiration in the Context of Resource Limitation What Is the Evidence Basis?. American journal of clinical pathology, 134(1), 60-64.
2. Balaton, A. J., Drachenberg, C. B., Rucker, C., Vaury, P., & Papadimitriou, J. C. (1999). Satisfactory performance of primary antibodies beyond manufacturers' recommended expiration dates. Applied Immunohistochemistry & Molecular Morphology, 7(3), 221.
3. Argentieri, M. C., Pilla, D., Vanzati, A., Lonardi, S., Facchetti, F., Doglioni, C., & Cattoretti, G. (2013). Antibodies are forever: a study using 12-26‐year‐old expired antibodies. Histopathology, 63(6), 869-876.
4. Drachenberg, C. B., Papadimitriou, J. C., Balaton, A. J., & Vaury, P. (2001). The total test approach to standardization of immunohistochemistry. Archives of pathology & laboratory medicine, 125(4), 471-471.

Regards

Tony Henwood JP, MSc, BAppSc, GradDipSysAnalys, CT(ASC), FFSc(RCPA)
Principal Scientist, the Children’s Hospital at Westmead
Adjunct Fellow, School of Medicine, University of Western Sydney
Tel: 612 9845 3306
Fax: 612 9845 3318
Pathology Department
the children's hospital at westmead
Cnr Hawkesbury Road and Hainsworth Street, Westmead
Locked Bag 4001, Westmead NSW 2145, AUSTRALIA

-----Original Message-----
From: jayalakshmy p.s via Histonet [mailto:histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>]
Sent: Thursday, 10 March 2022 1:27 PM
To: histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>
Subject: Re: [Histonet] Histonet Digest, Vol 220, Issue 8

Hello all, I would like to know whether Immunohistochemistry markers can be used after its expiry date(atleast in resource poor countries). If yes, for how much period of time and what is the criteria to look for?
Thanks and regards
Jayalakshmy

On Wed, Mar 9, 2022, 11:30 PM <histonet-request at lists.utsouthwestern.edu<mailto:histonet-request at lists.utsouthwestern.edu>>
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> From: Chenoa Hardwick <chenoa at pathologywatch.com<mailto:chenoa at pathologywatch.com>>
> To: histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>
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> Date: Tue, 8 Mar 2022 12:17:13 -0600
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> > I would like to post a job opening on Histonet.
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> > *Chenoa Hardwick*
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> > VP of Laboratory Services
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> > email: chenoa at pathologywatch.com<mailto:chenoa at pathologywatch.com> <michael at pathologywatch.com<mailto:michael at pathologywatch.com>>
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> From: Greg Dobbin <greg.dobbin at gmail.com<mailto:greg.dobbin at gmail.com>>
> To: Nancy.Schmitt at mercyhealth.com<mailto:Nancy.Schmitt at mercyhealth.com>, histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>
> Cc:
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> Date: Tue, 8 Mar 2022 16:00:14 -0400
> Subject: Re: [Histonet] formalin in OR
> Hi Nancy,
> All routine specimens in our hospital are placed in formalin in the OR.
> Breast lumps and mastectomy specimens are sent up fresh so that they arrive
> STAT (to minimize cold ischemic times) and lymph nodes for lymphoma
> protocol are also sent up fresh. [*they actually send sentinel nodes up
> fresh too- it was just less confusing*]
>
> Diagnostic Imaging will place routine needle core biopsies directly in
> formalin (e.g needle cores of breast, prostate, non-lympoma lymph nodes and
> other misc. tissue masses). Lymph node cores for lymphoma protocol and
> renal cores are sent to the lab fresh, in a container on saline soaked
> Telfa pads.
>
> Endoscopy places all of their specimens directly in formalin. The derm
> clinic will place all routine skins directly into formalin but specimens
> destined for immunofluoresence are sent up to the lab fresh in a container
> on saline soaked Telfa pads. EBUS specimens are split between Cytology and
> Histology...the histo specimens go directly into formalin.
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> Greg
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> Please contact Chenoa Hardwick at chenoa at pathologywatch.com<mailto:chenoa at pathologywatch.com> 972-351-0774
>
> *Chenoa Hardwick*
>
> VP of Laboratory Services
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> email: chenoa at pathologywatch.com<mailto:chenoa at pathologywatch.com> <michael at pathologywatch.com<mailto:michael at pathologywatch.com>>
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> mobile: +1 972.351.0774
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> <http://pathologywatch.com/>
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> From: John Garratt <john.garratt at ciqc.ca<mailto:john.garratt at ciqc.ca>>
> To: Nancy Schmitt <Nancy.Schmitt at mercyhealth.com<mailto:Nancy.Schmitt at mercyhealth.com>>, "
> histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>" <histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>>
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> Date: Wed, 09 Mar 2022 01:28:25 +0000
> Subject: Re: [Histonet] formalin in OR
> I would not normally promote a product but I have seen the TissueSafe and
> SealSafe (Milestone) in use at a couple of hospitals for formalin
> management in the OR and in the lab and was most impressed.
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> John
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> On Tue, Mar 8, 2022 at 9:54 AM, Nancy Schmitt via Histonet <
> histonet at lists.utsouthwestern.edu<mailto:histonet at lists.utsouthwestern.edu>> wrote:
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> > Hello-
> > I would appreciate input on how you are getting formalin on to the
> specimens:
> >
> > * Is it done in OR
> > * Are specimens brough to pathology and add formalin there
> > * If so - does lab or OR add the formalin
> > * Other?
> > Are you Joint Commission?
> > Thank you!
> > Nancy Schmitt MLT, HT(ASCP)
> > Pathology Support Services
> > Dubuque, IA
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