LexaMed’s ISO 17025 Accreditation Certificate has been updated on our Company Document page. You may also download a copy of it here.
LexaMed’s DEA Controlled Substance Registration Certificate has been updated on our Company Document page. You may also download a copy of it here.
LexaMed offers testing for AAMI Level 1 Minimum Fluid Barrier Protection Isolation Gowns and other barrier materials as defined in ANSI/AAMI PB70:2012. Testing is conducted in accordance with AATCC Test Method 42-2007 Impact Penetration Test. The test measures the resistance of fabrics to the penetration of water by impact, and therefore can be used to predict the probable resistance of fabrics to fluid penetration.
The health and well-being of our Employees and Clients is our number one priority. Quality, and confidence in our services is critical now more than ever considering the growing concerns about COVID-19 impacting the global environment. We are continually monitoring the situation and are following the Centers for Disease Control and Prevention (CDC) guidelines. We will continue to work with our customers to ensure we can provide you with the services needed while taking the appropriate measures to protect our staff and your test samples. The following actions list some of the measures we are currently taking.
• Employees that have the ability to work at home will do so.
• Critical test activities have been defined and a plan developed which will allow microbiologists to work a rotating schedule in order to minimize contact between associates yet ensure critical tests are carried out as scheduled.
• We have increased our already rigorous cleaning and disinfection activities to include on-going activities throughout each work day in all laboratories and sample receipt/handling areas.
• Any employee that discovers they may have been in contact with a confirmed case of COVID-19 are required to report this to management and self-quarantine for 14 days.
• All international and non-essential domestic travel has been cancelled.
• On-site visits including audits will be postponed. You will be contacted to reschedule your visit.
At this time, we do not anticipate any major impact to testing, if we anticipate there may be a delay you will be contacted immediately. These measures are not static and considering the uncertainty and unknowns with the situation, we want to stress that there is potential for change and we ask for your understanding in that event. LexaMed is committed to protecting our employees and community while doing our best to service our customers, please contact us if you have any questions or concerns.
Sincerely,
Rocile Parton
President and CEO
July 18, 2019 – LexaMed is proud to announce that it has passed the assessment required to receive accreditation to ISO 17025:2017 General requirements for the competence of testing and calibration laboratories.
LexaMed’s accreditation demonstrates technical competence in activities related to the following assays:
USP/ISO Sterility Test, USP/EP Antimicrobial Test, USP/ISO Endotoxin Test, Bioburden Determination, USP/ISO Cytotoxicity Tests, USP Particulate Analysis, USP Chapter <61> and <62> Microbial Enumeration, ISO Population Verification, USP Container Closure Integrity Test, ISO Ethylene Oxide Residual Analysis and Cleaning and Disinfection Validations for Re-usable Medical Devices
The addition of this accreditation to our existing certifications and registrations re-enforces our commitment to conduct and deliver high quality technically accurate work capable of withstanding regulatory scrutiny.