The purpose of this TriMark Publications report is to describe the specific market segment of the blood gas data management systems. This study includes all of the generally accepted clinical management systems that are currently used today. It examines these clinical measurement devices and their ancillary analytical instrument partners as utilized in hospitals, clinics and doctor's offices. Generally, the blood gas instruments that are marketed primarily as direct diagnostic products directly to hospitals and clinics are not included in this examination, but are described briefly for clarity. Wherever necessary, the individual data management systems of these instruments are also described. The emphasis in this report is on those companies and products that are actively developing and marketing instrumentation and supplies for performing managing data in the near patient environment. It focuses primarily on the hospital market segment, and, separately, on a description of the instruments and supplies marketed by major companies in this segment. The report covers eight basic areas:

• Comparison of instruments by company
• Clinical and laboratory assessment
• IT/technology
• Marketing/intelligence
• Blood gas and electrolyte analyzers
• Point of care testing overview
• Laboratory information systems
• Company profiles

1. Introduction
3. Section 1: Comparison of Instruments by Company
5. Questions to be answered and issues addressed in this section:
7. · Which blood gas analyzers will it interact with each instrument?
8. · Is there a limitation to the number of analyzers that can be connected to each data management instrument and if so, what is it?
9. · Will each instrument connect to blood gas analyzers from other vendors, and if so, which ones?
10. · Is there any change in functionality when interfacing equipment from different vendors?
11. · What data/information is available through the central data station other than basic patient information, e.g., instrument status information?
12. · What type of QA is built into each instrument, e.g., QC not run or failed lockouts, validated operator ID, demographic checks, and delta checks?
13. · What types of QC checks are used, e.g., fixed limits, +/- 2 SD, Westgard?
14. · Is the data flow bi-directional?
15. · What type of connection, e.g., RS232, Ethernet?
16. · Does the system allow for adjustment of QC ranges?
17. · Can offset and slope adjustments be entered to allow for matching results to other instruments?
18. · What type of interface is there to the LIS, e.g., scripting, HL7, ASTM?
19. · What types of management reports are available through the central data station?
20. · Can the interface pass the operator ID as well as the individual who verifies the data to the LIS? (In some cases these will be identical.)
21. · Will the interface to the LIS allow for point of care ordering, e.g., order entry and result entry on the fly?
22. · Can point of care test results from manual tests be entered thru the data management system?
23. · Overcoming the limits of bar coding technology.
25. Section 2: Clinical and Laboratory Assessment
27. Questions to be answered and issues addressed in this section:
29. · How well does the system meet the clinical needs of the laboratory?
30. · Are the QC/QA functions acceptable, too much, too little?
31. · Is there a Stat override for QC lockouts?
32. · Can patient ID requirement be by-passed in situation where it is not available, e.g., newborn, Jane/John Doe in ER?
33. · Is the speed of the system such that it is a benefit and not a hindrance?
34. · How complex is the data management system for the end-user to use?
35. · Evaluate the hospital competitive performance of review options, pass through to LIS, single point of connection to LIS, demographics, report formats, patient daily log and patient history reports.
36. · Quality control management and audit trail.
37. · Cross over study capability.
38. · Maintenance tracking capability.
39. · Security features.
40. · Monitoring capabilities.
42. Section 3: IT/Technology
44. Questions to be answered and issues addressed in this section:
46. · How are support responsibilities shared?
47. · Speed and scalability of database.
48. · What configurable network protocols can be used?
49. · How easy can applications be modified to institutional LIS/IS specifications?
50. · Who does an IT technician on a problem call work with?
51. · Can reports be accessed via thin-net clients, as well as fat clients?
52. · How many IP addresses are used or conserved?
53. · What are the bandwidth requirements?
54. · Time between break and fix of workstation.
55. · Backup mechanism to support recovery period.
56. · Procedure for handling test data while system is inoperative.
57. · Data security assessment of remote PC solution.
58. · Data security assessment of vendor access to a networked PC at an institution.
59. · Examination of features like serial transmission, TCP/IP for network transmission, serial connection to lab desktop computers.
61. Section 4: Marketing/Intelligence
63. Questions to be answered and issues addressed in this section:
65. · How many units have been sold in the U.S. by each company?
66. · Market share estimates.
67. · Pricing.
68. · Key hospital customers.
69. · Customer complaints.
70. · Instrument problems.
71. · Competitive strategies.
72. · Overview of the data management market place and current trends.
73. · Market analyses of the current market conditions, competition, and product mix and future trends.
74. · Identify new approaches to the marketplace.
75. · Discuss how each company is losing/gaining market share.
76. · Identify partnering opportunities with complementary third-party products.
77. · Detail principal investigators/department heads at major competitive accounts.
78. · Identify lab managers and technicians at major competitive accounts.
79. · Name physicians and nurses at major blood gas accounts.
80. · Discuss administration and purchasing.
81. · Detail a comprehensive description of each Account's unique situation, experiences and perceptions.
82. · Macro-analysis of all accounts profiled, and segmentation into specific groups with shared characteristics.
83. · Provide detailed strategy recommendations addressing each segment.
84. · Benchmark competitor performance.
85. · Investigate adjacent markets.
86. · Clarify market dynamics.
87. · Understand customer perceptions
88. · Explore new product concepts
90. Section 5: Blood Gas and Electrolytes
92. Section 6: Point of Care Testing Growth Regulators
94. Section 7: Laboratory Information Systems
96. Section 8: Company Profiles