Externally provided products and services
Taking into consideration what is stated in clause 6.8. Externally provided products and services and the samples are not taken in my laboratory but are taken in the different hospitals and provincial directorates of the Ministry of Public Health, how would be the best way to document this external sample collection service to the laboratory to comply with the requirements of the standard? should there be an agreement or contract, or simply documenting it in a procedure or policy is sufficient?
Comments
We are in a similar situation in our institution. As National Reference Laboratories, we receive samples from other laboratories and hospitals in our country.
In my opinion, the first action is to generate SOPs that contemplate sample collection, transportation, and other applicable requirements of the pre-analytical stage. These documents must be delivered to our users, and then it is possible to verify their understanding with a questionnaire. In addition, through indicators, we can verify the effectiveness of our actions and plan additional interventions, if necessary. In our case, establishing contracts is not feasible, but it may be an appropriate way. Besides, the possibility of auditing the laboratories and hospitals that take samples must be evaluated.
Moreover, we want to implement a project to train laboratories on the ISO 20658:2023 standard "Requirements for the collection and transport of samples for medical laboratory examinations". I had the opportunity to work on its translation at the Argentine Institute for Standardization and Certification (IRAM) and I found it to be a very interesting standard.
I agree with what @Nadia Bueno has said.
I suggest your lab establishes a document named as Service Level Agreement (SLA). This document would be an agreement between your lab and those external laboratories or health facilities that would be referring samples to the laboratory. In this SLA, there should be indication of the tests that will be referred to the lab, the prices that would be charged, discounts or commissions if any. Also, include the modality of sample collection and transportation to the lab, the expected TAT and modality of results delivery (hard copy or soft copy).
Usually, a meeting would be held where this document will be presented to external labs that required laboratory services for your lab, negotiations and adjustment would be done and then this SLA would be signed when an agreement has been reached between the two parties. Also, a confidentiality form would be signed in the end.
I hope this will be helpful and all the best!
Great comments and suggestions Nadia and Salome.
I agree with you both. The procedure is required so that both the lab and the users know what is required. We call it a sampling manual and we also have SLA with our users as it is a good addition to ensure compliance to those requirements.
Thank you very much Janet, Nadia and Salome for your contributions, they have been very helpful.