Asian Journal of Transfusion Science
Home About Journal Editorial Board Search Current Issue Ahead of print Back Issues Instructions Subscribe Login  Users: 297 Print this page  Email this page Small font sizeDefault font sizeIncrease font size 


 
ILLUSTRATION Table of Contents   
Year : 2020  |  Volume : 14  |  Issue : 1  |  Page : 96-97
Importance of documentation of the preanalytical variable on test requisition for sterility reporting of autoclave


1 Department of Transfusion Medicine, PGIMER, Chandigarh, India
2 Department of Medical Microbiology, PGIMER, Chandigarh, India

Click here for correspondence address and email

Date of Submission10-Apr-2019
Date of Acceptance09-Feb-2020
Date of Web Publication24-Jul-2020
 

How to cite this article:
Sachdev S, Lamba DS, Biswal M, Sharma RR, Marwaha N. Importance of documentation of the preanalytical variable on test requisition for sterility reporting of autoclave. Asian J Transfus Sci 2020;14:96-7

How to cite this URL:
Sachdev S, Lamba DS, Biswal M, Sharma RR, Marwaha N. Importance of documentation of the preanalytical variable on test requisition for sterility reporting of autoclave. Asian J Transfus Sci [serial online] 2020 [cited 2020 Oct 28];14:96-7. Available from: https://www.ajts.org/text.asp?2020/14/1/96/290642


We use self-contained biological indicators (BIs) for the monitoring of each autoclave run, and two such BIs (test: put in autoclave and control: one normal BI from the same batch as test) are sent to the department of medical microbiology for verification of the sterility test reporting. The change in color from the usual purple to yellow along with turbidity of the media is reported as failure of sterility test after necessary incubation at 55°C.

We report a case of apparent failure of sterility test of one of the autoclaves. A root cause analysis was conducted; after all steps were examined in sequence, it was found that there was no deviation from any step as per the standard operating procedure (SOP). The BI being used was EZ Test (Lot: S-507, Exp: January 5, 2020), Mesa Labs, France. The color change of the autoclave tape was satisfactory as documented in the register of the autoclave record, indicating that the temperature of 121°C was achieved. This can also be verified on the tape on the BI, brownish black (a) color change (in test) from light navy blue (in control) as depicted in [Figure 1].
Figure 1: The control (purple) and test (brownish black) biological indicators. (A) Test biological indicator (right side) demonstrating the change in color of the autoclave tape from light navy blue to brownish black. (B) Test biological indicator (right side) demonstrating the change in color of thermoplastic culture tube from purple to light brown

Click here to view


On detailed discussion with staff, it was noted that there was preanalytical change in color from purple to light brown (b) in the thermoplastic culture tube [Figure 1] of the BI after it was taken out from the autoclave, which was not documented on the sterility test requisition form. The change in color is due to caramelization of the tryptic soy broth, also described as nonenzymatic browning of media or Maillard-type reaction, which does not affect the performance of the BI.[1],[2]

A demo run was sent after duly acknowledging the preanalytical change to simulate the usual practice, without any change, which to our expectation was reported as satisfactory.

The case emphasizes the importance of documentation of the preanalytical variables on the test requisition form, with sensitization of staff involved, and incorporation of this change in the SOP for the monitoring of autoclave usage in accordance with the Standards for Autoclaving of Bio-Medical Wastes, Bio-Medical Waste Management Rules, 2016 in India.[3]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

1.
Caramelization or Darkening in the Color of Autoclaved Liquid BI Ampoules. Spore News™, Mesa Labs. Volume Number. Available from: https://biologicalindicators.mesalabs.com/wp-content/uploads/sites/31/2014/07/Spore-News-Vol-8-No. 3.pdf. [Last accessed date 05 May 2019].  Back to cited text no. 1
    
2.
Maillard-Type Reaction or Nonenzymatic Browning of Media. In, General Information, Media Preparation and Quality Control, Microbiological Laboratory Best Practices. The United States Pharmacopeial Convention; 2011. Available from: http://www.drugfuture.com/Pharmacopoeia/usp35/pdf/0707-0712%20%5b1117%5d%20microbiological%20best%20laboratory%20practices.pdf. [Last accessed date 05 May 2019].  Back to cited text no. 2
    
3.
Standards for Autoclaving of Bio-Medical Wastes. Standards for Treatment and Disposal of Bio-Medical Wastes. Bio-Medical Waste Management Rules. Ministry of Environment, Forest and Climate Change, Government of India; 2016. Available from: http://cpcb.nic.in/bio-medical-waste-rules/. [Last accessed date 05 May 2019].  Back to cited text no. 3
    

Top
Correspondence Address:
Dr. Suchet Sachdev
Department of Transfusion Medicine, PGIMER, Chandigarh
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ajts.AJTS_43_19

Rights and Permissions


    Figures

  [Figure 1]



 

Top
 
  Search

  
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Email Alert *
    Add to My List *
* Registration required (free)  


    References
    Article Figures

 Article Access Statistics
    Viewed203    
    Printed17    
    Emailed0    
    PDF Downloaded0    
    Comments [Add]    

Recommend this journal

Association Contact us | Sitemap | Advertise | What's New | Feedback | Copyright and Disclaimer

2006 - Asian Journal of Transfusion Science | Published by Wolters Kluwer - Medknow
Online since 10th November, 2006