College of American Pathologists
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cap today

October 2005

Raymond D. Aller, MD
Hal Weiner

Infection-tracking software rights the plight of Alabama hospitals
The right read: literature on blood bank validation plans
CCA to merge with StorComm
Korchek gets FDA clearance for blood product identification module
Public laboratory LOINC workshop and meeting
Health information technology IQ test

Infection-tracking software rights the plight of Alabama hospitals

While the phrase “reduce germs, save millions” is not yet a mantra, it has become a maxim at several Alabama hospitals.

As part of the Alabama Hospital Quality Initiative, rolled out in 2002, six hospitals began using infection-tracking software in a pilot program to reduce the occurrence of infections. During the next two years, the hospitals reduced their rate of nosocomial infections by more than 19 percent and saved $4.96 million, according to MedMined Inc., Birmingham, whose technology was used in the initiative.

The initiative focused on data mining, which uses advanced mathematical and statistical processes to analyze and track infections more quickly than by manually searching through data. MedMined’s patented Data Mining Surveillance service uses a form of artificial intelligence to continuously monitor the emergence of infection patterns hospitalwide and post-discharge, says Patrick Hymel, MD, MedMined’s co-founder and chief medical officer. The technology gives targeted information on where the infections are occurring and then offers what Dr. Hymel refers to as “actionable knowledge,” which may consist of actions that can be taken to eliminate the problem or steps to further investigate the cause of the problem. “The data mining service makes the practice of infection control much, much more efficient and much more targeted,” Dr. Hymel says. “It also closes the gap between the recognition of a problem and its solution.”

A critical part of the infection-tracking process, Dr. Hymel adds, is laboratory data. “MedMined services are really an example of how if you can process the data produced by the laboratory in the right way, then that laboratory data becomes a tremendous asset in the arsenal of the quality control personnel in the hospital,” he says, noting that one of the creators of the technology, Stephen Brossette, MD, PhD, is a clinical pathologist as well as a computer scientist.

The MedMined service features the company’s Nosocomial Infection Marker, an automated, surrogate marker that electronically measures the incidence of infections by hospital unit and hospital wide. The technology recently was accepted by the Pennsylvania Health Care Cost Containment Council to meet the state’s mandatory reporting requirements for nosocomial infections.

As of August, the quality initiative had grown to include 40 hospitals, representing close to 80 percent of hospital beds in Alabama, according to Jim Brown, senior vice president of customer relations for Blue Cross and Blue Shield of Alabama, which sponsored the use of MedMined’s technological and clinical services for the initiative. Brown declined to comment on how much BCBS invested in the initiative and how much the insurance carrier saved in the pilot program. “Because it’s really about the outcomes,” he says. “Intuition says, well if you’re reducing infections and you’re reducing length of stay, and you’re reducing re-admissions, then yes, that is going to save money. But the important thing is that patients get in and get out and don’t have the staph infections.”

The East Alabama Medical Center, a 352-bed regional facility in Opelika, became a part of the quality initiative about one and a half years ago. And in the year since the medical center acquired MedMined’s Data Mining Surveillance service, infection rates across the hospital have fallen 12.33 percent, reports MedMined. The technology has made the job of infection control staff easier, says Benja Morgan, RN, CIC, manager of infection control and employee health for the medical center. “It’s just a very helpful tool to have,” she adds. “You don’t even really need anybody to show you how to do it. It’s like click, and there [the data] is.”

In April, MedMined was named Birmingham’s fastest growing emerging company by the Birmingham Business Journal. As of mid-August, the company’s technology had been used at 128 hospitals in 23 states, including Butler (Pa.) Memorial Hospital and Evan ston (Ill.) Northwestern Healthcare.

MedMined ships a pre-configured server to the health care facility, which is installed on the organization’s computer network. The hospital server then sends encrypted data to MedMined’s server, where the data is “cleaned” of errant terms, such as misspellings, and made available for use by hospital staff.

Salt Lake City-based TheraDoc offers a similar product, but with its infection-tracking software, all data stays within the hospital’s server rather than being transmitted via the Internet to an outside server. TheraDoc continuously monitors laboratory, pharmacy, radiology, and other hospital clinical systems in real-time.

TheraDoc’s infection-tracking solution, Infection Control Assistant, has been on the market since 2001 and has been implemented in 11 health care facilities nationwide, including the Mayo Clinic, Jacksonville, Fla., and Johns Hopkins Hospital, Baltimore, says Michael Barton, PharmD, vice president of product development for TheraDoc.

TheraDoc’s software automates clinical documentation and reporting of infections within a facility that have been verified by an infection control practitioner, Dr. Barton says. “The gold standard for whether a patient has an infection is a clinician looking at it and determining whether there’s an infection present,” he adds.

Other providers of this type of infection-tracking technology include Cereplex, Germantown, Md., and Vecna, College Park, Md.

The right read: literature on blood bank validation plans

A CAP TODAY reader recently asked, “Are you aware of any articles that review the contents of a good blood bank LIS validation plan and key steps to ensure proper function?” Suzanne Butch, CLDir (NCA), administrative manager of the blood bank and transfusion service, University of Michigan Health System, Ann Arbor, responds.

The FDA recently rescinded the 1994 “Draft Guideline for the Validation of Blood Establishment Computer Systems” on the premise that it is not the current thinking of the agency. The 1987 FDA document “Guideline on General Principles of Process Validation” (available at cdrh/ode/ 425.pdf) is still applicable.

The Clinical Laboratory Standards Institute offers Auto-8, “Protocols to Validate Laboratory Information Systems; Proposed Guideline,” and GP19-A2, “Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline-Second Edition.”

I also recommend the book Information Technology in Transfusion Medicine (edited by myself and Marcus Simpson, MD), which is available from the American Association of Blood Banks.

Also available is the August 2003 supplement1 to the journal Vox Sanguinis, “ISBT Guidelines for Validation and Maintaining the Validation State of Automated Systems in Blood Banking.”

A risk analysis is now a required element of a validation plan. Quality tools such as a failure modes and effects analysis, or FMEA, can be used to assess risks and incorporate risk-reduction strategies in the computerized process. The amount of risk associated with a process step should drive the amount of validation done on that particular part of the system.

CCA to merge with StorComm

Creative Computer Applications, or CCA, a clinical information systems provider, has entered into an agreement and plan of reorganization with StorComm, a provider of picture archive communication systems and clinical image management systems for the medical imaging market. The merger is expected to be completed this fall.

Korchek gets FDA clearance for blood product identification module

Korchek Technologies has received FDA 510(k) clearance for its CareChek Tx blood product admin istration module of its patient identification system.

CareChek Tx for blood product administration and CareChek Rx for medication administration use bar-code technology to confirm that patients are receiving the correct blood product and medication. Korchek also offers CareChek Sp to ensure that patient blood, fluid, and tissue specimens are labeled properly at the bedside.

Public laboratory LOINC workshop and meeting

The Regenstrief Institute, National Library of Medicine, and Laboratory LOINC Committee will hold a public workshop and LOINC meeting in Indianapolis on Dec. 5 and 6.

The hands-on workshop will educate participants about the structure and distribution of the Logical Observation Identifier Names and Codes database and the use and utility of LOINC codes and the Regenstrief LOINC Mapping Assistant, or RELMA.

LOINC is an extensive, standard coding system for identifying laboratory test results.
For more information about the meeting or to register, go to or send an e-mail to, or a fax to the attention of “LOINC meeting” at 317-630-6962, or phone 317-630-8134.

Health information technology IQ test

The Medical Records Institute is offering the Health IT IQ quiz to test vendors’ knowledge about electronic health records and other health information technology. The test is available free of charge and is located on the MRI Web site,

“This is a fun way for HIT vendors to check their knowledge and challenge their peers,” says C. Peter Waegemann, CEO of MRI. The institute is working on a similar test for health care practitioners that will be released by the end of the year, he adds.

Although designed specifically for health IT vendors and consultants, the test can be completed by anyone visiting MRI’s Web site. It takes only a few minutes and involves 17 multiple-choice questions, most derived from MRI’s seventh annual EHR survey of trends and usage. Test score and evaluation are available immediately.


New York-Presbyterian Hospital has purchased Wyndgate Technologies’ SafeTrace Tx advanced transfusion management system. The system will be installed in the hospital’s New York-Presbyterian/Columbia and New York-Presbyterian/Allen Pavilion sites. Wyndgate also announced that it has signed a contract to install SafeTrace Tx at Pomona Valley Hospital Medical Center, Pomona, Calif. Terms of both agreements were not disclosed.

Dr. Aller is director of bioterrorism preparedness and response for Los Angeles County Public Health Acute Communicable Diseases. He can be reached at Hal Weiner is president of Weiner Consult ing Services, LLC, Florence, Ore. He can be reached at Dr. Weilert is director of laboratories, Community Hospitals of Central California, Fresno. He can be reached at