Importance of documentation of the preanalytical variable on test requisition for sterility reporting of autoclave

Suchet Sachdev; Divjot Singh Lamba; Manisha Biswal; Ratti Ram Sharma; Neelam Marwaha

doi:10.4103/ajts.AJTS_43_19

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ILLUSTRATION

Year : 2020 | Volume : 14 | Issue : 1 | Page : 96-97

Importance of documentation of the preanalytical variable on test requisition for sterility reporting of autoclave

Suchet Sachdev¹, Divjot Singh Lamba¹, Manisha Biswal², Ratti Ram Sharma¹, Neelam Marwaha¹
¹ Department of Transfusion Medicine, PGIMER, Chandigarh, India
² Department of Medical Microbiology, PGIMER, Chandigarh, India

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Date of Submission	10-Apr-2019
Date of Acceptance	09-Feb-2020
Date of Web Publication	24-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

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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

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].
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].
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].