The legal aspects of laboratory services

Dimah Talal Al-Sharif

In light of the pandemic developments that the whole world has been challenged with and faced, we have seen the emergence and evolution of many medical laboratory services. Therefore, the most important provisions of the private laboratory law in the Kingdom and its requirements must be addressed.
The laboratory industry requires a lot of accuracy and practicality. The law sheds light on the important aspects that managers and owners of these laboratories must comply with. This is to ensure the accuracy of the service provided by these laboratories to their beneficiaries, such as the registration requirements, timelines, and the stated fines in case of any violation.
Initially, the license is granted to laboratories on the condition that they commit to providing the necessary workforce of scientifically qualified specialists. They must commit to providing the equipment and devices necessary to perform the laboratory’s tasks and purposes in accordance with the volume and nature of the work, as determined by the authorities, as the owners and founders of these laboratories. Laboratories must be constantly aware of the regulations and all their updates according to the developments in the sector.
As for the stated period, the licensee is given a period of no more than 18 months, starting from the date of obtaining the license, to finish obtaining the required accreditation. In the event of the expiry of that period without the accreditation being obtained, the license shall be considered revoked. Regarding the duration of the license, its validity period is five years starting from the date of the previous grace period. The license can be renewed at the request of its owner or legal representative at least three months prior to the date of expiry. The renewal shall start from the date of expiry of the license.
Moreover, the laboratory shall abide by the following: Limiting tests to the commodities specified in the license for examination, maintaining the level of performance and accuracy in accordance with the profession’s principles, keeping records of test results, for a period of no less than five years, for reference when needed, presenting the license and accreditation certificate at the laboratory entrance, and adhering to confidentiality when transferring samples and test results, where no information can be provided except to the specialists.
Certainly, supervision is a very important element to ensure the accuracy of the services provided by the laboratory. Therefore, the law stipulates that specialist employees shall carry out the monitoring and inspection of laboratories and control any violations.
The law also gives these employees the authority to enter laboratories for inspection purposes, provided that the monitoring, inspection, and control personnel adhere to confidentiality and good behavior rules. During the inspection, they should also provide the laboratory with proof of their identity, official title, and purpose of the visit. As for the violations, the law stipulates that one or more of the following penalties shall be imposed on anyone who violates a provision of this law: Warning, a fine of no less than SR5,000 ($1,333) and no more than SR20,000 ($5,330), suspension of the license for a period of no less than 30 days and no more than 60 days, as well as withdrawing the license in case of recurrence.