To be added to the Trusted Travel List of Labs allowed to generate TT codes (commonly called the Trusted Labs Network), we are enjoined by international norms to verify your credentials as enabling you to offer clinical laboratory services in your native jurisdiction.
Whilst we strive to only onboard laboratories of the highest standards and integrity into the Network, we must rely on the capacity and work of the competent authorities in the jurisdiction in which the lab operates. The most critical validation we need is licensing or registration by a statutory or regulatory body. If your organisation outsources the actual testing and do not run your own facilities, then it is the statutory or regulatory licenses and registrations of the actual testing partner that we need to sight.
Of course, any additional accreditations and membership of professional bodies are useful, but the process of statutory registration and licensing would normally already take that into account, whilst periodic auditing ensures that standards are up to date.
With this context in mind, we would like to request a mix of documents from you to give us a high degree of assurance that we can recommend you to the travellers participating in the Global Haven program. Apart from statutory licensing or regulatory certificates, which are a legal requirement to operate, all other documents merely increase our confidence in our decisions to admit laboratories in the Trusted Labs Network.
1. Proof of Identity and Business Operating Certificates
Submit all registrations entitling you to operate as a business entity, non-profit or other corporate forms.
In many jurisdictions, a combination of the following is required to have legalbusiness identity (we need the minimum required in your jurisdiction):a. Copy of Business Registration Certificateb. Copy of Certificate of membership of the official business association (likethe Dutch Chamber of Commerce – KVK)c. Certificate of Commencement to Start Business.d. Provincial or Municipal Business Registration.
2. Proof of Statutory Registration or Licensing to Operate aClinical/Medical Laboratorya. Copy of Statutory Registration or License for the Facility from theCompetent Regulator (example CMS in the US, which is responsible forCLIA enforcement at the facility level).b. Provincial, state, sub-federal or Municipal registration for health facilities
3. Proof of compliance with industry standardsa. Copies of any Standards Certificatesb. Copy of Accreditation Certificates and latest audit reportsc. Data Protection Certificates or internal policies
4. Administrativea. Name and contact details of the business owner(s)b. Name and contact details of primary Management Contactc. Official Contact details for your businessi. Street Address of your facility (Headquarters preferred)ii. Official phone numberiii. Official email addressiv. Physical location of the business (This must include GPS Coordinates)
5. Training Questionnairea. What is the size of your team?b. Are all team members able to operate in English?c. Are all team members comfortable and conversant with Zoom and similar virtualplatforms for training purposes.
6. Creating of Apex User Account (Lab Admin)a. Name of Laboratory Admin (must be nominated by highest managementofficial involved in this onboarding process)b. Email Addressc. Phone number
Mode of Integration: Bulk Upload I Format (Web Wizard ,CSV, XLSX, XML, others)
Kindly give us as much information as you can to enable us fully appreciate the procedures for licensing, regulating and registering clinical/medical laboratories in your jurisdiction and how the credentials you have submitted through this process legally entitles you to perform the clinical/pathological/medical tests that you wish our members to access through you.
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