College of American Pathologists






cap today



November 2006

Raymond D. Aller, MD
Hal Weiner

KLAS keeps score: evaluates 2006 LIS marketplace
How HIMSS’ hurricane relief project has helped one medical center
Answers to lab-related questions about FDA bar-code rule
Atlas to supply ARUP Laboratories with connectivity services
Browser-side encryption module for EDC
MasterControl introduces product to simplify software validation

bullet KLAS keeps score: evaluates 2006 LIS marketplace The 2006 laboratory information systems study published by the independent research firm KLAS bodes well for a number of vendors, including Misys, Orchard, McKesson, Cerner, and SCC Soft Computer.

The 634-page report includes data on 18 vendors and 37 products and is divided into large and small laboratory information systems, anatomic pathology systems, and blood bank software. The study ranks vendors based on 40 criteria, including 10 product/technology indicators, 10 service indicators, eight success indicators, and 12 business indicators.

"The LIS study includes hundreds of positive and negative comments about dozens of vendors that were generated by laboratory directors, chief information officers, and LIS managers," says Ralph Reyes Jr., MT, senior vice president of KLAS. "The survey also includes feedback on several vendors that did not generate a large enough response rate to be included in the main body of the report, including Opus, NetLims, and others."

The study is based on numeric vendor evaluations coupled with a personal interview with each survey respondent. KLAS, which has been monitoring and reporting on the performance of health information technology vendors and professional services firms since 1996, surveys only health care managers and executives. The 2006 study reflects data collected from 894 respondents, representing approximately 1,500 health care facilities. Sixty-six percent of the study data were generated from laboratory executives and the balance from information technology and hospital administration staff.

One can use the survey to evaluate vendors on quality of implementation, response times, customer support, contracting process, costs after contract, and other factors. The study answers such questions as, Would users buy the product again? Would they recommend the product to others? Did the product live up to their expectations?

The report also analyzes why health care institutions did or did not select a vendor based on data collected from sites that purchased a system in the past two years. The majority of large system purchasers reported that single-vendor integration was the most important factor in choosing a system, while functionality was the most important factor for choosing a small system.

Overall, the scores generated by laboratory information systems have not kept pace with those of other health information technology products. The average score of HIT products increased notably from KLAS’ 2004 study, while the scores for small LISs decreased since that survey and the scores for large LISs increased only slightly.

It is important to note that just because a vendor scores high in this year’s survey does not mean it will continue to achieve that rating. Several vendors who ranked high in prior years’ surveys now rank at the lower end, while other vendors have improved their ranking.

For more information about the 2006 KLAS study, go to www. healthcomputing. com. To participate in KLAS’ nationwide HIT performance database and gain free access to the KLAS database, submit an evaluation to KLAS at www. healthcomputing. com/ online-eval.

—Hal Weiner

bullet How HIMSS’ hurricane relief project has helped one medical center Fifteen months after Hurricane Katrina immersed Waveland Medical Center and all of its paper medical records in 9 1/2 feet of water, the facility is slowly and painstakingly rebuilding its records with some help from the HIMSS Katrina Phoenix Project.

After the clinic, which is located in Waveland, Miss., about 35 miles east of New Orleans, was destroyed in the storm, staff initially attempted to save the clinic’s medical records, which had been stacked in a floor-to-ceiling rack. Staff members—one doctor, one nurse, and one secretary—pried apart paper records with a crow bar and laid them out to dry, says Lynn Murray, the secretary at Waveland. But "the ink ran, the mold grew, and they still weren’t dry" after a few weeks, she explains. "So they were all destroyed."

Today, however, the clinic, which serves about 500 patients, down from 3,000 before the hurricane, is on the road to recovery thanks to a new electronic medical record system that it secured with the help of the Chicago-based Healthcare Information and Management Systems Society, or HIMSS.

When the clinic reopened its doors just two weeks after the storm, Murray and the clinic’s nurse began taking patient histories from scratch. Meanwhile, the clinic’s physician came across an article about the HIMSS Foundation’s Katrina Phoenix Project, which matches health care facilities affected by the hurricane with electronic medical records software donated by vendors. Waveland submitted an application and was selected as the first practice to receive assistance under the project.

The HIMSS program selects software tailored to the size of the clinic, the services it offers, and the technologic savvy of its staff, explains David Collins, HIMSS manager for the Davies Awards program. For Waveland, HIMSS staff chose Soapware, marketed by Docs Inc., Fayetteville, Ark. "It’s just a simpler system to install," says Collins. "It’s fairly intuitive. [It] doesn’t have all the bells and whistles of some other systems, but for their needs, it suits them well."

The HIMSS Foundation also provided Waveland with a grant to cover the expense of implementing the software and related costs. True North Technology, Duluth, Ga., supplied Waveland with its Northstar software, which provides remote support, backup, and disaster recovery for Waveland’s system.

A few weeks before this summer’s go-live date, Docs Inc. installed Soapware remotely on Murray’s office computer. Collins, a representative from True North, and a volunteer HIMSS physician mentor then arrived to install the networked system and mentor the staff. The EMR software can write prescriptions, schedule appointments, and store pathology and radiology reports, among other tasks. However, these applications are not yet functional at Waveland. "So right now, all we do is put in their vital signs, history, and physical, and their office visit for that day," says Murray, who notes that pre-Katrina patients are returning to the clinic at a rate of about one per week.

HIMSS is awaiting the donation of a scanner so the clinic can more easily input such information as laboratory data, says Collins. In the meantime, the clinic’s paper medical records have been stored in a locked metal file cabinet as progress on the EMR system continues. "They told us it would take at least one year to go completely paperless," says Murray, adding that implementing the system has been a slow and sometimes painful learning process.

Collins acknowledges that the clinic’s go-live day was tense and nerve-wracking, but he adds that such emotions are to be expected of any software installation, especially one involving electronic medical records. Collins compares installing software to undergoing surgery: "You go in. You get prepped. They knock you out cold. They do the surgery. You wake up. You feel lousy. And then after a while, you’re functioning normally and you feel better than you ever did before. That’s pretty analogous to an EMR implementation." HIMSS plans to launch its Katrina Phoenix Project at up to 10 other health care facilities in Louisiana, Mississippi, and Alabama in the next four to six months.

bullet Answers to lab-related questions about FDA bar-code rule Last month the FDA issued a guidance for industry update to "Bar Code Label Requirements for Human Drug Products and Biological Products, Final Rule," which was published in the Federal Register in February 2004 and took effect earlier this year. The update contains answers to questions about the rule, which requires that bar codes be placed on the labels of thousands of human drugs and biological products. Specific questions and answers that are of interest to laboratorians are summarized below.

Q: What machine-readable information is required for blood and blood components?

A: The container label must bear encoded information in a format that is machine readable and approved for use by the director of the Center for Biologics Evaluation and Research, or CBER. The FDA recognizes two types of machine-readable information-Codabar bar-code symbology and ISBT 128.

Each label must have, at a minimum, a unique facility identifier, lot number relating to the donor, product code, and the ABO and Rh of the donor.

Q: Does a transfusion service that rarely prepares split units, pediatric units, and pooled cryoprecipitate units need machine-readable labels for such units?

A: Yes, the unit of blood or blood component label would contain the machine-readable information if the blood or blood component has any possibility of being transfused to a patient, whether or not the unit is transfused. Additionally, the phrase "from which the blood or blood component can be taken and transfused to a patient" would include the circumstance in which blood or a blood component is extracted or aspirated with a syringe from the container of blood or blood component for transfusion. This technique might be used when transfusing neonates or under other circumstances. In this case, a label containing the required machine-readable information must be affixed to the blood or blood component from which the aspirate is taken.

Q: How do we encode facility identifiers and product codes for pooled and aliquotted units for Codabar or ISBT 128? Where do we get information about these issues?

A: You can obtain information by sending an e-mail to the CBER’s Manufacturers Assistance and Technical Training Branch at The regulation requires a unique facility identifier.

Q: How will the FDA evaluate compliance with the bar-code rule?

A: FDA investigators will evaluate compliance with these regulations during routine inspections of blood establishments.

Q: May I request an exception or alternative under 21 CFR 640.120 for this requirement of the blood and blood component container label regulations?

A: Yes, but because the bar-code rule is intended to reduce transfusion errors and increase patient safety, the CBER will carefully review any request for an exception or alternative. The bar-code regulation for drug products recognizes that exemptions may be warranted when compliance would adversely affect the drug’s safety, effectiveness, purity, or potency, or when compliance would not be technologically feasible. In the preamble to the rule, the FDA noted that almost all drug products are capable of bearing a bar code.

The FDA also noted that it would not consider written requests based on financial reasons, a claim of a low rate of medication errors, or a claim that the product is unique and medication errors do not occur or rarely occur. In assessing requests for exemptions for blood and blood components, the FDA would follow the same approach described in the drug regulations (21 CFR 201.25(d)).

Q: Do the bar-code regulations apply to routine intraoperative or postoperative blood collection from surgical drains (salvaged blood) followed by reinfusion on the nursing unit or in other areas of the hospital?

A: No. In a 1989 memorandum to all registered blood establishments, the CBER delineated its policies on autologous blood. That memorandum stated that the quarantine, storage, record-keeping, and labeling requirements of 21 CFR Part 606 are generally not applicable to salvaged blood collected for proximate transfusion to the patient as part of the patient’s treatment (see bldmem/031589.txt). Because bar-code requirements fall under the category of label requirements contained in 21 CFR Part 606, the requirements would not be applicable to salvaged blood. However, the intent of the FDA’s bar-code rule is to reduce medication errors, including transfusion errors. To help reduce transfusion errors for salvaged blood, some hospitals may voluntarily begin using machine-readable information, including bar codes, blood bank computer systems, and bedside readers.

—Hal Weiner

bullet Atlas to supply ARUP Laboratories with connectivity services

ARUP Laboratories has entered a service agreement with Atlas Development Corp. whereby Atlas will provide physician office connectivity solutions for ARUP clients as part of the company’s ARUP Direct Total Outreach Solution.

Using Atlas LabWorks, ARUP client laboratories will be able to seamlessly interface with referring physicians through online order entry and test results.

bullet Browser-side encryption module for EDC

TrialStat Corp. has introduced a browser-side encryption module for hosted electronic data capture.

The patent-pending encryption module for TrialStat’s Clinical Analytics 3.0 EDC platform consists of a customer-managed security key that is used to encrypt and decrypt specified data fields before they are sent from a Web browser to a hosted server. The module’s encryption process obscures highly sensitive data elements so that only the users who created them and their colleagues at different research sites can view the details.

bullet MasterControl introduces product to simplify software validation MasterControl, a software provider for FDA-regulated companies, has introduced MasterControl Transfer Operational Qualification, or TOQ, to simplify and reduce the cost of computer software validation.

MasterControl TOQ provides completed validation and support documentation of installation qualification/operational qualification tests performed at MasterControl. This documentation serves as evidence that basic functions of a MasterControl application perform correctly against specifications required by the FDA.

Users of MasterControl TOQ increase their focus on performance qualification testing and simplify their requalification testing, which allows them to install upgrades more frequently.

bullet Contracts

Hospital Sisters Health System, Springfield, Ill., has chosen Meditech to be its main clinical information conduit, feeding and maintaining one integrated electronic medical record that will unite its 13 acute care hospitals across Illinois and Wisconsin. Vachette Pathology has signed a contract to assist Mercer Pathology Associates, Trenton, NJ, with practice management, billing auditing, managed care negotiations, and group revenue strategy.

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 Consulting Services, LLC, Florence, Ore. He can be reached at

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