ISRAC: A remote/on-site hybrid for accrediting PCR based COVID-19 molecular detection

The Coronavirus crisis forced ISRAC to adapt quickly. As in all other affected economies, performing an on-site assessment  presented a serious health risk to both the laboratory and the assessment staff. The risk was highest when assessing the performance of medical laboratories, especially those seeking accreditation for routine PCR-based COVID-19 detection.

In Israel, there is no regulatory demand for ISO 15189 accreditation. Nevertheless, two laboratories sought accreditation for a kit-based system.

Some of the challenges were instantly apparent. The technical assessor, while having vast knowledge needed to adequately assess the activity, was in a risk group. Furthermore, vaccines were not available.

To solve this challenge, aw remote assessment was used. However, this concept was relatively new. As e could not fully rely on remote tools, as it was unclear how efficient such an assessment can be. For that reason, we developed a risk-based approach to the viability of such an option. Including proper supporting infrastructure, type of assessment, and limitations to conducting observations and interviews properly. The last parameter in this risk-based approach was the presence of an ISRAC representative on-site, as we believed such a presence would lower the risk significantly.

Accordingly, the laboratory representatives assured us beforehand that the Wi-Fi signal is strong in all relevant workspaces and a lead assessor with experience in molecular biology was on site, along with a laptop setup with a remote communication program.

The assessment was certainly adequate, in part thanks to the cooperation of the staff. However, several problems arose. The two main issues revolved around the equipment used for the assessment. The noise in the room made the communication hard. Furthermore, the camera quality prevented the technical assessor from seeing items in a proper resolution, and she often relied on verbal descriptions given by the assessor on site. This dynamic slowed the process significantly, and arguably, without a representative on-site the assessment could not have been carried out adequately.

To improve on this performance, the equipment used at the second laboratory was upgraded and included Speakers, a microphone, and a Go-pro camera. The lab provided a cart that acted as a sort of portable assessment station, moving from one bench to another, and providing the technical assessor with much more information than before. The infrastructure needed was more of a challenge in this case, as the lab is set up underground, and the relevant workspaces were more spaced out. However, clear communication between ISRAC staff, lab management, and the hospital’s IT staff resulted in a clear and strong signal throughout the day. The addition of the go-pro camera allowed for greater flexibility in the visual aspect of the assessment. it was possible, for example, to examine tip positioning in the robot, hard-to-reach calibration stickers, and proper use of equipment inside the biological cabinets. The fact that the same assessors, both the technical and the lead, were the same in both laboratories was also beneficial as even this limited experience with a hybrid assessment made the second one better.

A pandemic made it necessary to come up with a new tool that would allow us to continue with our duties. While unforeseen issues had to be overcome, constant improvement and risk management allowed ISRAC to establish an adequate tool for remote and hybrid assessments. The assessors stayed safe, and all the aspects of the ISO 15189 standard were adequately examined. Hopefully, this new tool will not be put aside even after a global return to normalcy.