- Abbott/UCC RSS Trial

NEWS
From BTI

RSS Works at Bedside
The Abbott Trial

REDUCED SPACE SYMBOLOGY™ FOR SMALL HEALTHCARE ITEMS FROM PRINT TO BEDSIDE

Figure 1: Al Schwindt, Chief of Pharmacy, St. Alexius Medical Center, reading RSS on a test ampul.
Uniform Code Council, Inc 1009 Lenox Drive, Suite 202
Lawrenceville, NJ 08648 1

© 2001 Uniform Code Council, Inc.

In this publication the letters "U. P. C." are used solely as an abbreviation for the "Universal Product Code," which is a product identification system. They do not refer to the UPC, which is a federally registered certification mark of the International Association of Plumbing and Mechanical Officials (IAPMO) to certify compliance with a Uniform Plumbing Code as authorized by IAPMO.

© 2001 Uniform Code Council, Inc.

PARTICIPANTS
Abbott Laboratories, Hospital Products Division and St. Alexius Medical Center

EXECUTIVE OVERVIEW
This Reduced Space Symbology (RSS) case study validates that current commercial equipment can print, verify and read RSS symbols on small healthcare items.

BACKGROUND
The Uniform Code Council, Inc. (UCC) developed the RSS and Composite Component symbologies to answer the business needs of its members. The UCC is a not-for-profit, voluntary standards organization. There are over 250,000 member companies in North America. Approximately 10% of these companies are from the healthcare sector.

Today, 90% of all healthcare items can be coded using existing linear symbologies. The other 10%,---generally unit-of-use items and unit dose items dispensed to the patient at the hospital bedside,---are too small to allow the use of existing linear symbologies. RSS, encoding the full 14 digit Global Trade Item Number (GTIN) meets the basic identification needs of the world healthcare manufacturers, distributors and suppliers. Bar coding down to the dispensed unit when used with appropriate complementary software has the potential to reduce medication errors significantly. In the United States, the National Coordinating Council for Medication Error Reporting and Prevention (www. nccmerp. org) stated that all items should be bar-coded down to the unit of use with the National Drug Code (NDC), lot number and expiration date. These three data elements can easily be placed in an RSS with Composite or an UPC with Composite. The EAN. UCC system enables the ten digit NDC to be encoded into the UPC.

The Composite Component, a two-dimensional symbology, was created to work with linear symbols to carry additional information such as lot number and expiration date. The linear symbol carries the primary data such as the NDC enclosed within the GTIN. The UCC requested volunteers from every part of the healthcare supply chain to develop guidelines for the use of RSS and Composite. As a result, in 1999, the North American RSS/ Composite Implementation Group was formed. The group, whose attendees are listed as an attachment, meets on a semi-regular basis to develop application guidelines for the use of this new symbology. Membership in this group is voluntary. The UCC acts as the secretariat for these meetings. The meeting minutes are published on the UCC web site (www. uc-council. org)

There are also implementation teams working with RSS in the produce and variable measure sectors. The same UCC website contains a full description of their progress.

An initial agenda item of the Healthcare team was to select the appropriate RSS symbol to prototype. The RSS Limited and RSS-14 Stacked were selected as the first two test symbols. RSS Limited is used on items, requiring a narrow horizontal symbol such as syringes. RSS Stacked is used on items, requiring a narrow vertical symbol such as vials. It was decided that a test of the RSS would be first, then followed by the Composite (2D).

The first two tests were extremely successful. Synopsises of the first two case studies are found in Appendix D. The complete Case Studies can be found on the UCC website. The drfat North American RSS/ Composite Application guidelline can be found on the UCC website.( www. uc-council. org)

ABBOTT / ST. ALEXIUS MEDICAL CENTER

Test Plan
The UCC and Abbott jointly developed a test plan. The lessons learned from previous case studies were incorporated in the Abbott test plan. A copy of the Abbott test plan can be obtained by contacting the UCC. The test plan was modified based on the circumstances/ environment encountered at the test sites. These modifications did not alter the results.

PROTOTYPE TEST PRINTING

Two packages were selected for this test. RSS Stacked was selected for the 2-ml single dose fliptop glass vial and RSS Limited for the 1-ml single dose glass ampul. The GTINs and the bar width reduction are printed below:

Test Vial and Test Ampul with the associated RSS labels.
2-ml vial RSS Stacked: (01) 00614141672219

1-ml ampul RSS Limited: (01) 00614141672110
Bar code symbols will be printed at "x" dimension 0.0067 inch with 0.002 inch bar width reduction.

ABBOTT LABS AUGUST 16, 2001

Hospital Products Division
Founded in 1888 by Dr. Wallace Calvin Abbott, a Chicago physician, Abbott is a global diversified healthcare company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. Abbott's products and services span the continuum of care –from prevention and diagnosis to treatment and cure. The company employs approximately 70,000 people and markets its products in more than 130 countries.

Abbott Hospital Products Division is a fast growing business with a diversied portfolio of hospital-based pharmaceuticals and medical devices. Abbott focuses on five areas that serve the high-acuity segments of the US hospital market: perioperative and intensive care pharmaceuticals, cardiovascular, oncology, renal care, and acute care injectable drugs and delivery systems. Abbott's hospital products portfolio also includes electronic drug delivery systems and I. V. solutions and supplies.

READING, VERIFICATION AND APPLICATION OF LABELS
The team at the manufacturer's plan consisted of Katherine Bellamy, Jean Cotton, Shawn Astabraghpour, Keith Bitzinger, Gary Smith and Wil Das of Abbott Labs; Glen Spitz of Webcan; James Chronowski, Ray Delnicki, and John Roberts, of UCC. Ron Barenburg of International Barcode Corporation was also there.

Sixty labels from each label run (60 RSS Stacked paper vial / 60 RSS Limited, polyester ampul, 120 in total) were counted and given to Glen Spitz for verification. From a prior test print run a BWR of .002 inch was deemed appropriate for this test. The actual test verification indicated a lower grade on the printed label than anticipated. This result justified the use of a test run prior for BWR correctness prior to production. These actual tests grade results indicated a BWR of .0015 inch might result in a higher verification grade. James Chronowski and Ray Delnicki, using different manufacturer scanners, read the labels directly off the print roll prior to placement on the ampul and vials. The scanner manufacturers were Hand Held Products (an affiliate of Welch Allyn) readers, IT4410HD, and IT3800 and Symbol Technologies "Cyclone". In this manner human and mechanical differences were minimized.

Scanners Chronowski Delnicki Read

© 2001 Uniform Code Council, Inc.
Abbott kept the remaining labels on the print rolls. The labels were applied mechanically to the product (vial and ampul) containers, and successfully read 100% after application to the container using both the HHP scanners and the Symbol Cyclone scanner.

Reading vial RSS Stacked

Scanner Number/ RSS type/ Container Read

Reading ampul RSS Limited

Reader Number/ RSS type/ Container Read
Symbol Cyclone 120 RSS Limited on ampul All successful HHP IT4410HD 120 RSS Limited on ampul All successful HHP IT3800 120 RSS Limited on ampul All successful The intermediate containers were then packed. The vials and ampul went in different intermediate packs as per Abbott commercial usage. The remaining 20 labels were retained by Abbott.

Ampul
There were a total of 100-glass ampuls, 5 to a carton, 5 cartons or 25 ampuls to a shrink-wrap. A total of 4 shrink-wraps or 100 ampuls were packed.

Vials
25 glass vials were placed in each intermediate pack. A total of 4 intermediate packs of vials or 100 vials were packed in a case. Each intermediate pack was identified with a label containing a GTIN encoded in an UCC/ EAN-128 symbol. The GTIN identifies the product. The three commercial scanners successfully read each symbol. This part of the test proved the commercial scanner can auto discriminate capability among RSS Limited and Stacked symbols and a traditional EAN. UCC linear symbol. These multi-pack cases were then placed into a shipping container and mailed to Bismarck North Dakota.

Abbott intermediate test pack with UCC/ EAN-128 symbol
ST. ALEXIUS MEDICAL CENTER VISIT
Participants:
Keith Bitzinger Abbott; Frank Kilzer, Chief Materials Management, St. Alexius; Kim Christiansen, R. Ph., Pharmacy Information Systems Coordinator, St. Alexius; Al Schwindt, Pharmacy Director, St. Alexius St Alexius; Ron Barenburg International Barcode Corporation and Wil Das Abbott. Not shown James Chronowski, John Roberts, and Ray Delnicki, UCC.

Figure 4: Participants (left to right) Keith Bitzinger Abbott; Frank Kilzer, Chief Materials Management, St Alexius; Kim Christiansen, R. Ph., Pharmacy Information Systems Coordinator, St. Alexius; Al Schwindt, Pharmacy Director, St. Alexius Medical Center; Ron Barenburg, International Barcode Corporation and Wil Das, Abbott. Not shown, James Chronowski, John Roberts, and Ray Delnicki, UCC.

Hardware: Hand Held Products -HHP IT3800 (This imaging reader is not regularly calibrated, and was not calibrated before this test).

Collection Software: HBOC PC View 32 for Windows.

St. Alexius Medical Center: A 300-bed facility located in Bismarck, North Dakota. St. Alexius is known for its promotion and implementation of bar code identification of healthcare products down to the unit of use. The test site was an unoccupied hospital room.

The two different intermediate packages from Abbott were provided to St. Alexius. The test items consisted of 200 product samples: 100 vials and 100 ampuls with the corresponding RSS symbols. There were (100) glass vials with the RSS Stacked in (4) intermediate packages. The intermediate packages were labeled with an EAN. UCC 128. There were (100) glass ampuls marked with an RSS Limited in (4) intermediate packages. Each intermediate package was labeled with an EAN. UCC 128.

50 glass vials and 50 glass ampuls were scanned by Kim Christiansen, R. Ph., Pharmacy Information Systems Coordinator, St. Alexius and Al Schwindt, Pharmacy Director. The test samples were selected randomly. Kim Christiansen scanned the test products from a distance of approximately three (3) inches. Al. Schwindt scanned the test items from a distance of approximately six (6) inches. Al. Schwindt initially had some difficulty reading on the first pass. Once he got the "hang of it", he experienced no further difficulty and proceeded to read his samples (scanners from different manufacturers may have different optimum reading distance). A sample of the test database screen is attached as Appendix "C". All 100-test samples were read successfully and entered into the database.

PARTICIPANTS REACTIONS RSS and the Test

All the St. Alexius' participants were pleased at the ease of reading. They remarked about the small size of the symbol and how easily it could be read. The participants mentioned that items numbering in the thousands that are used daily would make worklife more efficient if RSS labeling were used.

Healthcare Database Issues

A healthcare issue unrelated to the RSS test was also addressed. Most healthcare software packages are stripping the NDC from the bar code rather than using the GTIN as a pointer to the database as the standards require. Such a program necessitates different software for both pharmacy and non pharmacy. For example, the non-medical surgical database would use the GTIN as a pointer to a data base file, which would read it and store it in its entirety. The pharmacy would require software that could strip the NDC from its bar code and thus making it unnecessary to store the entire GTIN, as the standards require. Such a dual entry system does require twice as much maintenance as a single entry system. GTIN is a non-logical number that should be used as a pointer to a database file.

Abbott test vial intermediate pack with EAN/ UCC128 symbol VERTIFICATION

There were two types of label used in the live test conducted at Abbott Laboratories, one was paper and the other was vinyl. Statistical results, of the measurements made, indicate that the stacked (paper substrate) achieved higher grades than the limited (vinyl substrate) labels. From a previous test, using a paper substrate, it was determined that a two mil (0.002 inch) bar width reduction to be the best compensation for the printing process and the paper substrate. To determine the best bar width reduction for the vinyl substrate, the same testing process should be used. The complete results from the vertification are enclosed as Appendix E.

APPRECIATION

The UCC appreciates all the work of the individuals involved in this case study. Their companies are to be commended for allowing them to spend the considerable time and effort to make this test successful. It is believed that this case study will enhance current efforts to reduce medication errors through product identification to the unit of use.

CONCLUSION

The test proves that RSS Limited and RSS Stacked can be commercially printed applied and read by the manufacturer. Manufacturers can use this symbology to place the GTIN (with an imbedded NDC) on small healthcare products that can not be bar coded using existing EAN. UCC linear symbologies. And finally, the healthcare provider/ customer can successfully read the composite into their database applications.

TECHNICAL DATA

Currently, 6.7 mil is the smallest recommended X dimension for RSS Limited and RSS– 14 Stacked for successful reading by commercial equipment. The RSS can be produced in a smaller size, but it could affect successful reading. As always, where there is available space on the label, any bar code, including RSS and composite, should be produced as large as possible. Human readable data should always be printed where space is available. However, it could be waived for pharmaceutical items when this information (NDC) is already printed in human readable on the label and there is insufficient space. As always, laws and regulations supercede UCC guidelines. © 2001 Uniform Code Council, Inc.

APPENDIX A

NORTH AMERICA HEALTHCARE GROUP

Keith Bitzinger Abbott Laboratories Greg Hamlin Alcon Laboratories
Jerry Johnson Pharmacia Tom McInally Bergen Brunswig
Roger Pierce CMOP, Los Angeles Al Schwindt St. Alexius Medical Center

Rick Fox Fox IV Andrew Longacre Welsh Allyn
Karen Longe Karen Longe & Associates Rick Schuessler Symbol Technologies, Inc.
Burton Schultz Medalert Terry O'Brien Medalert
George Wright, IV Product Identification & Processing Systems, Inc.

Nigel Wood Electronic Commerce Council of Canada Frank Sharkey Uniform Code Council, Inc.
John Roberts Uniform Code Council, Inc

APPENDIX B

POINTS OF CONTACT:
For more information about this test or specific contacts at the companies involved, contact:

John Roberts Uniform Code Council, Inc.
609 620 4563 jroberts@ uc-council. org

This hospital bedside screen at St Alexius Medical center displays the test patients name, the medication to be administrated including dosage, the providers name, and the date and time of administration.

Appendix 'D': Synopsis of Previous Case Studies

ALCON LABORATORIES / ST. ALEXIUS MEDICAL CENTER CASE STUDY

The first practical application of RSS Limited and RSS Stacked on small healthcare products is documented in the Alcon Labs / St. Alexius Medical Center Case Study. This document is on the UCC web site (www. uc-council. org). The healthcare application guideline for the use of these symbols in North America can be found on the UCC website at: www. uc-council. org/ focus_ by_ industry/ fi_ draft_ healthcare_ guidelines. html:

Figure 2: RSS Limited and RSS Stacked on 3ml Alcon products set out on patient bedside table at St. Alexius Medical Center December 2000 prior to test reading.

PHARMACIA / DEPARTMENT OF VETERANS AFFAIRS CONSOLIDATED MAIL OUTPATIENT PHARMACY CASE STUDY
This case study validated the use of Composite Component with the linear symbol UPC-A and RSS Limited. The customer CMOPs required expiry date and lot number is bar-coded, in addition to the GTIN, on pharmaceutical products delivered to its facility. This document can be found on the UCC web site (www. uc-council. org).

Figure 3: A test label being placed on the Pharmacia product. Each label contained an UPC-A with a composite component and a RSS Limited with a composite component. It is not commercial practice nor within the EAN. UCC guidelines to have two barcodes on the same package. It was done for test reading purposes only.

Originally Published: 09/01/01

Date Posted: 03/15/03 18:55:10

(All copyrights for this article remain with the original copyright holders, if applicable.)