"It must be possible."
This conviction has been the driving force behind HemoCue for over 35 years. To do things easier. To do them better. To do them right.
What the inventors, Jan Lilja and Sven-Erik Nilsson, saw as they visited labs and doctor's offices triggered the spark that drives human invention: the ability to see possibilities where others just see problems. They saw the frustration within healthcare of having to wait to treat patients or adjust test values that were always 30-40% off. They saw the inaccuracy and dangers of limited reagent durability, shifting instrument calibration, and pipetting. The impracticality of the time it took to send samples to the lab - so troublesome that healthcare workers preferred to send the patient instead.
They saw, of course, that overcoming these problems would not only make things easier and quicker for physicians, nurses, and labs, but could also save lives. There was no doubt. It had to be done. And it had to be done right. It took time and involved much effort. After all, they were working with an exact science inside a microworld. One that had to be repeatable, yielding the same value - the right value - time after time. It was difficult and often frustrating. Seemingly at every turn, they were told, “It’s impossible”.
Yet, they never gave up. Never compromised. And achieved something remarkable — a point-of-care blood test with tolerances never before thought possible, let alone repeatable with accuracy in tens of millions of cuvettes per year.
And that was only the beginning. Their problem-solving focus and drive has been instilled in the hearts and minds of everyone in the HemoCue family since then. With a positive, open-minded atmosphere, HemoCue continues to foster a belief in possibilities and a dedication to getting it right. If there’s an issue or challenge, it’s not just an issue for one person, but for the whole company. Everyone is interested in solving it. Because every detail matters for our customers. It’s that “can do” team spirit that has led to a continuous stream of game-changing innovations over the past 35 years.
Facts and Figures:
Jan Lilja, laboratory engineer, and Sven-Erik Nilsson, computer expert, of the Kristianstad Hospital Clinical Laboratory begin outlining an improved method for measuring hemoglobin.
The soundness of the method and the feasibility of microcuvette production are proven.
A license agreement with pharmaceutical company Leo is signed. Toward the end of the year, Lilja and Nilsson move into Leo’s premises.
Leo begins selling and distributing the first hemoglobin photometers.
The hemoglobin system is successfully introduced on the US market. Turnover rises almost 80%.
Leo is purchased by Pharmacia.
Leo Diagnostics is bought out by the management and HemoCue AB is formed.
Acquisition of US Distributor – HemoCue Inc. is founded.
The glucose system, based on the same principles as the hemoglobin system, is introduced to the market.
HemoCue finds a new owner: Mallinckrodt Inc of Saint Louis, Missouri, USA.
The first HemoCue Academy takes place in Norrköping, Sweden.
HemoCue is acquired by EQT, a private equity group in northern Europe. Annual turnover exceeds $40 million.
A new system, HemoCue® Plasma/Low Hb System, is introduced. The system is used for determination of low hemoglobin levels in plasma, serum and aqueous solutions.
HemoCue® Donor Hb Checker, a system for measuring hemoglobin in blood donors, is introduced.
The HemoCue 201 System for glucose is introduced.
By introducing a Urine Albumin analyzer for detecting microalbuminuria, HemoCue enters yet another significant testing area.
The HemoCue 201 System for glucose is followed by a HemoCue® 201+ System for both glucose and hemoglobin making it possible to store test and QC results in the analyzer.
HemoCue makes extensive investments in production technology, R&D, Sales and Marketing. Acquisition of Biotest. Distribution agreements with McKesson and PSS.
HemoCue® Data Management Systems for glucose and hemoglobin are launched in Europe.
Market introduction of HemoCue® Home Glucose.
Market introduction of HemoCue® Albumin 201, HemoCue® Hb 301 and HemoCue® Glucose 201 RT.
HemoCue is acquired by Quest Diagnostics.
Market introduction of HemoCue® WBC, a system for determination of total white blood cell count. HemoCue® Albumin 201 System receives first FDA CLIA waiver in diagnostics industry for quantitative point-of-care test for microalbuminuria.
HemoCue® WBC DIFF is introduced. A system that provides a quantitative determination of white blood cells with a five part differential count of neutrophils, lymfocytes, monocytes, eosinphils and basophils.
HemoCue U.S. Leadership Team
Sr. HR Business Partner
Sr. National Distribution Sales Mgr.
Specialty Markets Director
National Sales Director
Financial Planning Mgr.
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Integrity and Compliance
HemoCue America is part of the Danaher Corporation. Acting with integrity is a necessary foundation for personal success and for Danaher’s collective success. Building and sustaining a strong culture of integrity and compliance is critically important to building a premier global enterprise.
A culture of integrity and compliance provides a clear competitive advantage for Danaher. Danaher is committed to building an enterprise with integrity, and has a reputation for dealing honestly and fairly with investors, business partners, customers, associates and competitors.
As a company that develops, produces, manufactures and markets medical technologies, HemoCue America is fully committed to complying with the AdvaMed Code of Ethics on Interactions with U.S. Healthcare Professionals (HCPs). This includes individuals or entities involved in the provision of healthcare services to patients, or which purchase, lease, recommend, use, arrange for the purchase or lease of Radiometer technologies in the United States.
Purpose of the Code of Ethics
To ensure that collaborative relationships meet high ethical standards, they must be conducted with appropriate transparency and in compliance with applicable laws. AdvaMed recognizes the obligation to facilitate ethical interactions between Companies and HCPs to ensure that medical decisions are based on the best interest of the patient.
Visit advamed.org for more information.
California Comprehensive Compliance Program and Compliance Declaration
HemoCue America is committed to doing business in accordance with the highest standards of business conduct and ethics, and we consider our reputation for ethical and compliant behavior to be a valuable corporate asset. Accordingly, HemoCue has established a Compliance Program ("CP") in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400?119402 (the "Statute"), based on our good faith understanding of the requirements of the Statute as it may apply to a medical device manufacturer, and the Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance") published by the Office of Inspector General, U.S. Department of Health and Human Services.
Our Compliance Program, applied in conjunction with our MedTech Healthcare Professional Engagement Policy ("MedTech Policy"), is tailored to HemoCue's size, organizational structure, available resources, and the nature of our business as a medical device manufacturer. The medical device industry has established, and HemoCue’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the "AdvaMed Code"). The AdvaMed Code is a voluntary ethical code substantially similar to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the "PhRMA Code") but was developed with a primary focus on the unique interactions between medical device manufacturers and healthcare professionals and is thus more uniquely suited to Beckman's compliance needs.
This is a description of HemoCue’s Compliance Program. It reflects the plan and policies we have implemented, but the Compliance network is a dynamic and continuously developing entity requiring coordination between multiple policies and programs as well as the commitment of our management team and associates. While adoption and implementation of appropriate policies cannot guarantee complete elimination of improper conduct, it is HemoCue’s expectation that all associates will comply with our Compliance Program and all applicable laws, rules, and regulations. HemoCue’s passion for continuous improvement in all areas of our business dictates that we regularly review and enhance our Compliance Program to adapt to our evolving compliance needs.
Overview of Compliance Program
Leadership and Structure.
Our Compliance Program has been developed by Radiometer’s Compliance leadership and is managed by its desginated Compliance Officer. Company Management works with the Compliance team to ensure Radiometer effectively prevents, detects, and reacts to instances of non-compliance.
Policies and Procedures.
Radiometer America Inc.’s Code of Conduct is our statement of ethical and compliance principles that guide our daily operations. The Code establishes that we expect management, employees, and agents of the Company to act in accordance with law and applicable Company policy.
The Code articulates our fundamental principles, values and framework for action within our organization.
As required by the California Health & Safety Code 119400-119402, we also have established an annual spending limit of $1,500 for certain promotional activities directed toward healthcare professionals in California.
Education and Training.
A critical element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements. Radiometer America Inc. is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel. Moreover, Radiometer America Inc. will regularly review and update its training programs, as well as identify additional areas of training on an “as needed” basis.
Internal Lines of Communication.
Radiometer America Inc. is committed to fostering dialogue between management and employees. Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retribution. Radiometer America Inc. has established a Compliance Hotline to allow for anonymous reporting of potential violations of law or Company policy.
Auditing and Monitoring.
Radiometer America Inc.’s Compliance Program includes efforts to monitor, audit, and evaluate compliance with the Company’s compliance policies and procedures. We note that in accordance with the HHSOIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
Investigating and Responding to Potential Violations.
Our Compliance Department monitors company functions and activities for potential violations of law, regulation, industry codes, the Code of Conduct and company policies. Potential violations are promptly and thoroughly investigated and appropriate corrective action taken.
Corrective Action Procedures.
In determining the appropriate response to an established violation, our Company considers various options for corrective action. These options include remediation to evaluate current practices and close any gaps in policies, practices or training that may have led or contributed to the violation, as well as the imposition of disciplinary action up to and including termination.
STATE OF CALIFORNIA COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION
July 1, 2020
To the best of our knowledge, HemoCue America has established a Compliance Program in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 1 19400-1 19402 (the “Statute”), based on our good faith understanding of the requirements of the Statute as it may apply to medical device manufacturers. HemoCue Americahas developed a Compliance Program consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers (which is expressly applicable to medical device manufacturers) published by the Office of Inspector General of the U.S. Department of Health and Human Services. Our Compliance Program is tailored to the size, organizational structure, nature of our business as a medical device manufacturer, and resources of our Company. The medical device industry has established, and HemoCue America’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”). The AdvaMed Code is a voluntary ethical code established by the medical device industry. It is substantially similar to the Pharmaceutical Research and Manufacturers of America Code on lnteractions with Healthcare Professionals, but reflects the unique interactions between medical device manufacturers and health care professionals.
While adoption of appropriate policies does not necessarily guarantee that improper employee conduct will be entirely eliminated, it is HemoCue America’s expectation that employees will comply with our Code of Conduct, healthcare compliance policies and other policies adopted in support of the Code. Furthermore, our Compliance Program has been designed to prevent and detect violations. In the event HemoCue America becomes aware of potential violations of law or Company policy, the Company will, where appropriate, investigate the matter, take disciplinary action, and/or implement corrective measures to prevent future violations. This description of our Compliance Program reflects the plan we have implemented. We will periodically reassess the program to improve it, and may refine the elements as necessary. HemoCue Americais committed to upholding the highest standards of business conduct and ethics in its relationships with customers, employees, shareholders, the business community, and state and federal governments.
Join Our Team
We are always looking for talented people to join the HemoCue team. HemoCue is part of the Danaher family of companies, within the Diagnostics platform. Danaher is a global science and technology innovator with more than 20 operating companies and a globally diverse team of 59,000 associates united by a shared purpose: to help realize life's potential. When you join HemoCue, you are also becoming a member of the Danaher organization and all that it has to offer. You can visit and apply to our open positions on Danaher's Careers site, as well as learn more about what it's like working for Danaher, and what the process is for candidates.