Legal And Policy
Legal and Policy Statements
We strive to provide the latest technology for solutions in healthcare to streamline pharmacy operations and improve patient safety. The Baxa Web site provides detailed information on Baxa product specifications, Technical Papers, Instructions for Use, Policy and Procedure Guidelines and more. The following are the policies and guidelines that govern the development of Web site information and other Baxa collateral and/or guide our daily operations.
If you have questions or concerns about the statements within this section, or your interactions with this Web site, contact us here or at 800.567.BAXA (2292), or by writing:
Baxa Corporation
14445 Grasslands Drive
Englewood, CO 80112
Attention: Marketing Department
COMPANY RESPONSIBILITY
APPLICABLE LAWS
DISCLAIMER
COPYRIGHT
DISASTER PLANNING
ENVIRONMENTAL POLICY
GLOBAL AVAILABILITY
GRAPHIC SYMBOLS USED IN LABELING
HIPAA COMPLIANCE STATEMENT
INVESTOR RELATIONS
LATEX FREE STATEMENT
PEDIGREE STATEMENT
PRIVACY STATEMENT
PRODUCT CHANGES
RETURNED GOODS POLICY
TRADEMARK STATEMENT
WARRANTY STATEMENT
WEEE COMPLIANCE STATEMENT
COMPANY RESPONSIBILITY
This Web site contains proprietary notices and copyright information, the terms of which must be observed and followed. Information on this Web site may contain technical inaccuracies and/or typographical errors. Baxa makes no representation or warranty that the information contained on this and other Baxa Web sites is timely or error-free. Information may be changed and/or updated without notice. Baxa may make improvements and/or changes in products and programs described in this information at any time without notice.
This site contains links to related Web sites as a convenience to users. Baxa cannot review all of the sites that may be linked to this site and does not endorse, and is not responsible for, the content of any off-site pages or other sites linked to these sites. Your use of information presented within the Baxa Web site, and on other sites linked to this site, is at your own risk. The reliability of Baxa products is warranted to the extent of the terms in our published Warranty Statement.
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APPLICABLE LAWS
Baxa Web sites are administered from its headquarters offices in Englewood, Colorado and contain information about products that may or may not be available in any particular country. Individual products may have received approval or market clearance by a governmental regulatory body for different indications and restrictions in different countries, as each country has specific laws, regulations and medical practices governing the communication of medical or other information about medical products on the Internet. Information herein should not be construed as a solicitation or promotion for any product or indication that is not authorized by the laws and regulations of the country where the reader resides.
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DISCLAIMER
All of the information, graphics, links and photographs provided on this Web site are the exclusive property of Baxa Corporation and are provided expressly for the use of our customers. Baxa Corporation does not warrant the accuracy or completeness of the information, graphics, links and photographs included within the Web site contents.
Reference information presented within this Web site and other Baxa microsites has been assembled from published sources, laboratory testing reports, manufacturers’ data and tests conducted at Baxa Corporation. These data have been carefully compiled and are believed to be accurate. The reference materials offered on this Web site and any other Baxa microsites or printed collateral are provided as a guide for practitioners. Technical references and other materials are not intended to replace the informed judgment of qualified healthcare professionals. Baxa Corporation has no control over the conditions of use for its products, and those that it distributes. Information regarding the usage and reliability of Baxa products is subject to the products’ conditions of use; therefore Baxa makes no warranty claims excepting those in our Warranty Statement.
The Baxa Web site (www.baxa.com) contains information about products that may or may not be available in any particular country. Each country has specific laws, regulations and medical practice governing communication of information about medical products on the Internet. The materials within this Web site should not be construed as promotion for any product that is not authorized by the laws and regulations of the country where the reader resides.
This site may contain information on medical topics and guidelines for use related to the use of Baxa products. This information is meant as a reference tool and does not replace the knowledge and judgment of a medical professional, or the policies and procedures of a healthcare institution.
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COPYRIGHT
USE OF THE THIS WEB SITE INDICATES THAT YOU ACCEPT THE TERMS OF USE BELOW. IF YOU DO NOT ACCEPT THESE TERMS, DO NOT USE THIS WEB SITE.
Baxa Corporation authorizes users to view and download the materials at this Web site only for personal, non-commercial use, provided that they retain all copyright and other proprietary notices contained in the original materials on any copies of the materials. The entire content of the Site, including any images or text, is copyrighted and may not be distributed, reproduced, publicly displayed, downloaded, modified, reused, reposted, or otherwise used, except as provided herein, without the express written permission of Baxa Corporation. Use of these materials on any other Web site is prohibited. All product names are trademarks of Baxa Corporation and its business partners, unless otherwise noted. The use or misuse of these trademarks, copyrights, or other materials, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law, communications regulations and statutes, and other laws, statutes and/or regulations.
Permission is granted to Baxa customers to use, copy and distribute the documents (such as white papers, data sheets, press releases and FAQs), related graphics and multimedia materials contained within this Web site, subject to the following provisions:
- Materials are for internal, personal, informational and non-commercial use only.
- Copies of materials from this Web site include the Baxa copyright notice and attribution for all trademarks and service marks.
- Use of materials from this Web site does not grant license to the user under copyright, trademark, patent or other intellectual property rights of Baxa Corporation.
NOTICE SPECIFIC TO SOFTWARE AVAILABLE ON THIS WEB SITE.
Software that is made available to download from this Web site is the copyrighted property of Baxa Corporation and/or its suppliers. Use of this Software is governed by the terms of the end user license agreement, which accompanies or is included with the Software, and subject to the limited warranty provided by Baxa Corporation.
Use and/or installation or downloading of software from this Web site indicates use acceptance of and the license terms in the Software License Agreement that accompanies or is provided with the Software. If no such Software License Agreement accompanies or is provided with the Software, user agrees to accept a limited, non-exclusive, non-transferable license to use the Software as is solely for internal business purposes in relation to the use of this Site. Baxa software users: (1) may not translate, disassemble, decompile, reverse engineer, alter or modify Baxa Software or make any copies of any documentation or Software (except one copy for back-up or archival purposes only); (2) may not sell, assign, sublicense, transfer, disclose, or permit access to the Software or related documentation to any other person or entity; and (3) DISCLAIM ANY AND ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO THE SOFTWARE.
Reproduction or redistribution of copyrighted Software not in accordance with the License Agreement is expressly prohibited by law, and may result in severe civil and criminal penalties.
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DISASTER PLANNING
Baxa Corporation recognizes that it is a critical supplier of goods and services to healthcare providers. As such, we want to ensure that we have policies in place to offer continuity of service in the event of a disaster or pandemic. While we cannot guarantee continuity of service during a pandemic or other unforeseen and catastrophic event, the following policies help to ensure prioritization of product availability to allow safe and continued delivery of Baxa products.
- All of Baxa Corporation's disposable products have minimum stock levels in place that are designed to ensure that we have adequate inventory to meet normal customer demand.
- It is our goal that items that are identified as critical for facilities to function (such as disposables that complement Baxa hardware) are never out of stock. We work hard to ensure that customers have adequate disposables to ensure that they can continue to run their Baxa hardware in normal pharmacy production.
- Use of Baxa disposables is required under facilities' hardware contracts, therefore should we experience a stock shortage we would recommend a switch to an alternative Baxa product. In the case of the Baxa TPN bags, this substitution may be for a different-sized bag until stock is available.
- Baxa internal disaster recovery plans provide contingency plans to ensure that critical processes can continue in the event of an unforeseen emergency. In the event of an emergency, these plans would remain in place until recovery to normal operations.
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ENVIRONMENTAL POLICY
Baxa Corporation is committed to manufacturing operations that minimize the opportunity for environmental harm and support sustainable resources. As a provider to the healthcare market, we strive to choose the most efficient materials for our products – those which have the greatest potential for patient safety and clinical efficacy and the least potential for adverse environmental impact.
Operations
Baxa Corporation strives to address environmental impact in all of its operations – whether they are manufacturing or office activities. The company adopted lean manufacturing practices in 1999 to reduce manufacturing waste and streamline receiving, assembly, packaging and shipping activities. Continuous improvement programs ensure that all processes are continually examined and updated to ensure that we are eliminating unnecessary activities, which reduces energy consumption, optimizing product packaging to reduce cost and waste, and addressing all current regulatory and customer-driven requirements.
The Baxa manufacturing plant, built in 2002, represents the state-of-the-art for efficiency in lighting, air handling and process control. Baxa manufacturing processes do not consume water and the company has a recycling policy for all supplies, such as paper, cardboard and plastic, that can be reused and/or recycled.
Materials of Construction
The materials used in producing and packaging Baxa disposable products meet all market requirements for form, fit and function, and are chosen for the least impact on the environment when they are burned or disposed. Most of Baxa Corporation’s products also meet the stringent disposal requirements for the European Union (note that a few products are not sold in the EU, but still meet applicable requirements). The company’s products incorporate recycling codes wherever possible. Click here for a list of materials of construction and their applicable recycling information, or check the current product catalog.
Packaging
When products are designed, the company chooses the least-dense packaging configurations that meet customer and market needs in order to reduce unnecessary waste. Every opportunity is taken to consolidate shipments to reduce the cost and energy consumption for transportation to wholesaler partners or direct customers. To minimize waste, Baxa products are packaged in the most convenient volumes for customer usage. However, we also make every effort to provide products in bulk containers that minimize unnecessary packaging and offer low-cost alternatives to traditional product packaging. While most of Baxa Corporation’s products are disposable, we repair and recycle all of our hardware and equipment and reuse shipping pallets and other materials wherever possible.
Office Transactions
Baxa Corporation adopted electronic data interchange (EDI) transactions many years ago to provide efficient order processing with minimal paper. Wherever possible, we encourage and support our trading partners in using electronic ordering vs. fax, phone and other paperless transactions. Internal troubleshooting and reporting programs are software-driven and designed to minimize paper support wherever possible. In addition, Baxa endeavors to use the best means possible to enable customer transactions and supports GHX, Broadlane, Neoforma and similar initiatives to streamline healthcare purchasing.
Use of Recycled Materials
Wherever practical, Baxa Corporation uses recycled paper in its office, marketing and sales support activities. The company’s Web site offers product manuals, instructions for use and other technical and marketing information in electronic format to reduce customer reliance on paper documents. In addition, the company supports an active recycling program for office paper and waste, as well as shipping cartons and other materials.
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GLOBAL AVAILABILITY
Baxa publishes information on its Web sites that contain references or cross references to products and services that have limited regional availability. Such references do not imply that Baxa intends to announce or sell such products or services in your country. Consult your local Baxa representative for information regarding the products and services available in your region.
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GRAPHIC SYMBOLS
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HIPAA COMPLIANCE STATEMENT
Baxa Corporation designs and sells software for pharmacy labeling, total parenteral nutrition calculation and solution order entry. We are not a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), however we may act as a Business Associate in the provision of technical support related to our compounding system hardware and software. In order to assist our customers in assessing their risk related to the use of Baxa software, we offer the following compliance information.
No Baxa Corporation software is involved with claims adjudication processing, so it is exempt from the requirements for standard coding and message sets.
Baxa Compounding System Software Products
Rapid-Fill™ and Kwik-Vial™ Label Programs contain no individual patient health data, and therefore do not fall under the act.
Abacus™ and TPN-PC Plus™ Software maintain some patient health data, and are covered by the act. The software provides the following security features:
a. Database changes are audit trailed.
b. Users are individually identified and authenticated using a unique user ID and password.
c. Users are given permissions to restrict their access only to the areas they need.
d. The applications automatically log users off after periods of no activity.
Exacta-Mix™ 2400 and 600 Software. This software controls the operation of the EM2400 and 600 Compounders, respecitvely. The software has access to patient names that may come along with the orders generated by TPN-PC Plus and Abacus. The software provides the following security features:
a. Database changes are audit trailed.
b. Users are individually identified and authenticated using a unique user ID and password.
c. Users are given permissions to restrict their access only to the areas they need.
d. The application automatically logs users off after periods of no activity.
MicroMacro™ Operating Software. This software controls the operation of the MicroMacro12 and 23 Compounders. It maintains no patient information in its databases, and therefore has no need to provide an audit trail for database transactions. It does receive files from TPN-PC Plus for compounding solutions and those files may contain patients names. The software has the following security features:
a. Users are individually identified and authenticated using a unique user ID and password.
b. Users are given permissions to restrict their access only to the areas they need.
c. Application automatically logs users off after periods of no activity.
All of the Baxa Corporation’s software programs are designed to reside and operate inside of the private network of the covered entities using the software. The security of the data files is ensured by the overall security the user facility’s private wire network provides.
Based on this information, it is Baxa Corporation's view that a covered entity using our software is capable of being HIPAA compliant.
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INVESTOR RELATIONS
Baxa Corporation is a privately held company and as such provides information to the public only on our Web site (www.baxa.com) and in formal press releases. Press communications regarding partnership agreements are available on the Baxa Web site and through online news media. It is our policy not to communicate directly with shareholders of partner companies. If you have questions related to CDEX Inc. (www.cdex-inc.com) , or other Baxa business partners, please contact their respective investor relations teams.
If you have any questions, or need further clarification on this statement, please contact us at baxamail@baxa.com or call us at 303-690-4204.
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LATEX-FREE STATEMENT
Baxa Corporation is committed to providing customers with non-latex products wherever possible. Currently all of our medical products and equipment are latex free. We do, however, sell labels that contain synthetic latex in their adhesive. These labels are not for direct patient contact, but are used to identify drug container contents.
The following label products may contain synthetic latex in their adhesive:
Label-Ease™ Labels; Order Nos. 631, 633, 634, 635, 636, 637, 638, 639
TPN PC™ Plus Labels; Order No. 03-0505
TPN Labels; Order No. DPS-TPN-2-1
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PEDIGREE LAW STATEMENT
Under the Prescription Drug Marketing Act of 1987, the Federal Food and Drug Administration called for regulations requiring drug distributors to provide documentation of the chain of custody of drug products, otherwise known as a pedigree – throughout the distribution system. Final regulations implementing the law were published in 1999, however the the FDA delayed the effectivity date because of the fear that it would be too costly for small distributors to comply.
In the meantime, individual states were encouraged to adopt their own pedigree laws. As of July 2006, the Florida Prescription Drug Act required authentication upon transfer or receipt of all drug products. Originally passed in 2003, this ‘pedigree’ law is to be phased in over three years to allow suppliers time to comply with its requirements. The law was enacted to protect Florida consumers from the risks of counterfeit drugs.
Baxa Corporation works with all major medical wholesalers to stock and deliver its medical devices to hospital and alternate-site customers. Our commitment to our customers is to provide quality products that comply with all applicable international, national and state regulations governing medical devices. At this time, Baxa devices and ‘kits’ do not include any drug products and therefore we do not have any pedigree requirements under the Florida Prescription Drug Act.
Baxa Corporation does not sell, distribute, or otherwise include any drug products with our devices. We do not ship drug products to Florida or to any other state or country. As a medical device manufacturer, our products are not included in the Florida Pedigree Law or the FDA equivalent of the law.
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PRIVACY STATEMENT
Baxa Corporation respects the privacy of visitors to our Web site. We strive to adhere to the highest standards of ethical practice in all of our operations and are dedicated to protecting user privacy. This Privacy Statement outlines the information Baxa Corporation may collect about users when they visit our site and how we will use that information.
Collecting Your Personal Identification
Most of the Baxa Web site is accessible without providing personally identifiable information. For promotions, online purchasing, and other interactive services users may wish to provide this information voluntarily. Users who opt not to provide us with personally identifiable information may be unable to receive more detail on product/service offerings and/or be unable to download software; product upgrades or participate in product demonstrations.
When users write to us with comments and suggestions, we will respond only to them and will NEVER make any personally identifiable information available to a third party.
Use of Your Personal Information
If users provide personal information to Baxa Corporation, we will use it only for the following purposes:
- To make the site easier to use by not making users enter your personal information more than once.
- To deliver services that are requested or purchased.
- To help users quickly find account or product information.
- To help us create and publish content most relevant to users.
- To alert users to product upgrades, special offers and other new services from Baxa.
Our Web site server collects domain names (not email addresses) of visitors to our Web site in order to measure the number of visits, pages viewed, etc. This information is used to determine the use of our site and to improve its content.
If you have any questions, or need further clarification on this statement, please contact us at baxamail@baxa.com or call us at 303-690-4204.
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PRODUCT CHANGES
Baxa Corporation makes all reasonable efforts to contact customers about critical product changes prior to their implementation. Nominal product changes and those that improve product quality may be made at our discretion as part of continuous product improvement.
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RETURNED GOODS POLICY
Contact Baxa Customer Support immediately to report dissatisfaction with Baxa Products and to receive a Returned Goods Authorization (RGA). Baxa Corporation will do everything possible to resolve the issue. No returns are accepted without prior approval. Products must be returned unused and in undamaged condition. No returns are accepted on shipments ordered six (6) months or more prior to the date of the return request. The customer is responsible for return freight charges, except where the return is due to Baxa shipping error. A restocking fee may be charged for returns due to customer ordering error or overstocking.
TRADEMARK STATEMENT
The following are US Registered Trademarks owned by Baxa Corporation or an affiliated company: Baxa, Cyto-Safe, Exacta-Med, MicroFuse, PadLock, PIBA and the Baxa logo.
The following are Common Law Trademarks owned by Baxa Corporation or an affiliated company:
Abacus, AbacusLink, Adapta-Cap, Bandolier, Baxa Bucks, calcTPN, CathCare, CriticalPoint, CyTwo-Fer, Direct-Entry, DiscPac, Exacta-Mix, Kwik-Vial, Label-Ease, Mark-a-Dose, MedBoard, MicroMacro, NeoThrive, P2 Technology, Rapid-Fill, Repeater, SureConnect, TPN-PC, TPN-PC Plus and Two-Fer.
Failure of a mark to appear in this statement does not mean that Baxa does not use the mark, or that the product is not actively marketed or is not significant within its relevant market.
The following trademarks are owned by third parties and may be used in this Web site or in other publications owned by Baxa Corporation: Halobag (Nutrishare), Windows (Microsoft Corporation), OHAUS, Supor (Pall Corporation), ShrinkSafe (ShrinkSafe Systems LLC), SmartPak (Samson Medical), SmartSite (Alaris). Use of these trademarks by Baxa Corporation does not imply an endorsement of the related companies or products.
Baxa Corporation logos and trademarks may not be used without prior written permission. Questions about this listing of trademarks should be directed to marian.robinson@baxa.com.
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WARRANTY STATEMENT
Baxa Corporation warrants that its Products shall be free from material defects and shall conform to, and perform in accordance with, the related documentation supplied by Baxa including specifications and directions on Product. In the event of notice of a breach of this warranty, Baxa shall, at Baxa expense, replace the defective Product. Unless the Product is used in accordance with the Product operating instructions, the warranties are void.
Unless specifically set forth in this Web site, and other Baxa Web sites, no representational warranty regarding product performance, whether express or implied, by any sales representative or other agent of Baxa Corporation, shall be binding on Baxa Corporation. This is an exclusive warranty. Any remedies under this warranty are restricted to repair or replacement of the defective product. Baxa Corporation is in no way liable for incidental or consequential damages. This warranty policy may be superceded by individual equipment warranties incorporated in Baxa contracts.
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WEEE COMPLIANCE STATEMENT
WEEE is the European Waste Electrical and Electronics Equipment Directive and applies to a wide range of electrical and electronic products. The objective of WEEE is to reduce waste from electrical and electronic products and components; promote the reuse, recycling and other forms of recovery of such wastes; and to improve the environmental performance of all producers involved in the life cycle of electrical and electronic products.
The Directive transfers the responsibility for collection, treatment, recycling and recovery of waste electrical and electronic equipment to the companies that manufacture, sell, distribute, recycle or treat electronic products and components in the European Union. Baxa strives to be an environmentally responsible corporate citizen and our equipment is used worldwide, therefore we extend this responsibility to our global customers.
Baxa Corporation operates under full compliance with the WEEE Directive. Among the requirements of the directive is the marking of any applicable equipment placed in the EU market with the WEEE symbol (the crossed-out, wheeled garbage bin at right); demonstration of the implementation of a take-back program; and meeting recycling targets. Baxa labels all applicable equipment with the "Wheelie Bin."
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Copyright 2007 by Baxa Corporation. All rights reserved. Last Revised: December 15, 2007.
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