Legal note


TRADEMARK STATEMENT

The Instrumentation Laboratory logo, GEM, Premier, GEMweb, iQM, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlastin, SynthASil, Synthafax, ROTEM, Hemochron, Avoximeter and VerifyNow are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners. 

POLICIES

Environmental Policy

Instrumentation Laboratory (IL) maintains an environmental management system for the design, development, manufacture, distribution and servicing of IVD Devices and Reagents.

IL is committed to reducing the adverse impact of our activities, products, and services through recognition and support of: 

  • The key influential role of design and operational activities in environmental management 
  • The link between public health and the environment

IL is committed to training and participating in environmental policy issues for the benefit of our employees, customers and the public. IL will achieve these through: 

  • Continuous improvement of energy usage and waste management 
  • Pollution evaluation and prevention, wherever possible and practicable, by the use of non-polluting techniques and practices 
  • Continuing to inform and train our employees on environmental initiatives and waste management programs 
  • Compliance with all laws and regulations pertaining to relevant environmental legislation, regulations and other public sector requirements

          Environmental Policy
          Quality Policy

Pandemic Policy

This notification is to make you aware of our plan to support Instrumentation Laboratory (IL) products in the event of a pandemic or natural disaster, specifically our response to this year’s H1N1 flu virus. Instrumentation Laboratory is sensitive to the fact that an interruption of service or product delivery may have an adverse effect on our customers. We have a global cross-functional team that has prepared a pandemic plan for our core business areas such as production, logistics, technical service, field service and customer support. 

Following the guidelines of the Centers for Disease Control (CDC), Federal Emergency Management Agency (FEMA), and the European Centre for Disease Prevention and Control (ECDC), we have reviewed our internal procedures and policies to mitigate any impact to our customers. As per the Business Pandemic Planning Checklist from the CDC (www.cdc.gov), and the Business Continuity Planning referred by the ECDC (www.ecdc.europa.eu), all aspects of the business have been evaluated. In addition, we actively monitor the recommendations of national and global health organizations such as the World Health Organization (WHO) and guidelines from the Ministry of Foreign Affairs (MOFA, Japan) for the Pacific Rim. 

To this end, we are expanding our response to such emergencies as warranted in a global market by taking the steps below:

  1. IL ensures delivery of our raw material from suppliers through two methods:
    • Levels of consignments located in each manufacturing site are equivalent to 3 months of material.
    • Kanban levels: on reserve we ask our suppliers to commit to 3 months total inventory. Two months at the supplier and one month in IL inventory.
  2. IL requires that our critical suppliers all have a disaster recovery plan in place.
  3. IL has at least one month of finished goods inventory in stock, and analyzes appropriate increases in inventory to meet the needs of the customer should demand increase.
  4. IL maintains six months of Hemostasis reagents. Presently, Critical Care and specific reagents are stocked per shelf life limitations. We are especially sensitive to the levels of expendables and reagents in the distribution network. IL continuously monitors inventory to safety stock levels.
  5. If required, IL has the capability of utilizing multiple manufacturing sites in Europe and the US for reagents.
  6. IL has distribution points in the US, Europe and the Pacific Rim, in addition to Dealer inventory to ensure a continuous supply of reagents or expendables.
  7. IL has excess capacity in each manufacturing location and production could be ramped up quickly if required. i.e. using overtime, split or second shift, etc.
  8. IL has a high level of cross training across product lines; therefore we have a flexible and well trained workforce. This enables us to be able to rapidly reallocate resources as needed.
  9. We have the option for non-manufacturing workers (engineering, customer support, finance and QA) to work remotely, should the situation warrant. Our operating system (SAP) and the network is accessible through the internet with the appropriate access controls.

To ensure our Customer Service support:

  1. IL Service is prepared to maintain worldwide Service and Support to our products through our network of Affiliates, Distributors and Dealers. This will be accomplished through redundancies in both our labor force and parts supply chain.
  2. Each Service group has multiple individuals trained on each of the products. In case of illness to one individual, others can step in to service the product. As a result, the labor force will not be compromised and can maintain support.
  3. Service parts are maintained in multiple locations throughout the world including Distribution Centers in Bedford, MA., Orangeburg, NY, and Cavenago, Italy as well as Japan and the Pacific Rim. In addition, the individual Affiliates maintain a quantity of service parts, located in both their home offices and in the personal possession of their Field Service Representatives.
  4. In total; the Affiliate Service Managers have been instructed to maintain a local inventory level equal to 2 months of the Service and Support needs.

We feel that the steps we have implemented above, and our internal programs, will sufficiently mitigate any risk of interrupted product delivery or support to our customers.

Please feel free to call if you have any additional questions at 781-861-4184.

Sunshine Act

IL Corporate Fact Sheet on the Sunshine Act. Please consult CMS for additional information. 

California Supply Chain Act

At Instrumentation Laboratory we are dedicated to conducting business in a lawful and ethical manner. We are unconditionally opposed to human trafficking and believe that all workers have the right to freely choose employment, and have a workplace free of unlawful harassment and discrimination. Therefore, Instrumentation Laboratory expects its suppliers to equally act as responsible corporate citizens and to take affirmative actions to protect the rights of their workers against human trafficking.

Before engaging in business with any supplier, Instrumentation Laboratory, as part of its Initial Supplier Assessment Process, asks the supplier whether it respects internationally recognized standards prohibiting child and slave labor and whether it promotes safe and healthy working conditions.

In addition, Instrumentation Laboratory includes in the standard terms and conditions of its purchase orders that any vendor or contractor providing goods or services comply with all applicable laws, statutes, rules, regulations and orders in effect in the countries and jurisdictions in which they do business. Finally, To ensure our contractors and suppliers respect and enforce our company standards, Instrumentation Laboratory requests that all suppliers sign Instrumentation Laboratory’s Supplier Certification which requires the supplier to respect internationally recognized standards prohibiting child and slave labor and promoting safe and healthy working conditions.

The focus on slavery and human trafficking is part our larger commitment to corporate responsibility and respecting human rights in our own operations and in our global supply chain.

With specific regard to the California Transparency in Supply Chains Act, Instrumentation Laboratory provides the following information: 

  1. Verification: Before engaging with any new supplier, Instrumentation Laboratory requests that the supplier verify, as a part of its Initial Supplier Assessment Process, that the supplier respects internationally recognized standards prohibiting child and slave labor and promotes safe and healthy working conditions. Verification is not conducted by a third party. 
  2. Audits: Instrumentation Laboratory does not currently audit our suppliers specifically for compliance with company standards on trafficking and slavery in supply chains. Instrumentation Laboratory does, however, periodically audit its suppliers for compliance to relevant quality systems and standards. 
  3. Certification: To ensure our contractors and suppliers respect and enforce our company standards, Instrumentation Laboratory requests that all suppliers sign Instrumentation Laboratory’s Supplier Certification which requires the supplier to respect internationally recognized standards prohibiting child and slave labor and promoting safe and healthy working conditions. Instrumentation Laboratory also includes a clause in our general terms and conditions of purchase that requires all suppliers to certify they are in full compliance with all applicable laws, statutes, rules, regulations and orders in the country or countries in which they are doing business. 
  4. Internal Accountability: Instrumentation Laboratory does not currently have internal corporate policies specific to slavery and human trafficking. We do, however, expect all employees and third parties who interact on behalf of the Company to adhere to the WerfenLife Code of Ethics, which requires compliance with all national and local laws, regulations and professional codes that apply to the areas within the scope of their work responsibilities. 
  5. Training: Instrumentation Laboratory periodically provides training to appropriate members of its procurement staff on the California Supply Chain Act. 

AdvaMed Code

          AdvaMed Code of Ethics and FAQs