The Four R’s in LIS Selection
The Four R’s in LIS Selection
When selecting your next laboratory information system, know how it will incorporate patients’ rights, regulations, reporting and reimbursement.
As we begin the 21st century, laboratories that serve the health care industry face an onslaught of requirements that are affecting how they do business. Government regulations, patients’ rights to privacy and return on investment have become as important to lab directors as the accuracy and expediency of the lab reporting process.
This is particularly true in a case like the laboratory affiliated with the University of California Davis Medical Center (UCDMC). A multi-disciplinary laboratory that supports a major teaching and research facility, the laboratory has approximately 200 FTEs serving several distinct patient populations: hospital inpatients, outpatient clinics and physician practices groups as well as an outreach program. In all, the laboratory performs more than 3 million tests a year.
For many years, UCDMC’s laboratories have used the electronic Laboratory Information System (LIS) developed by Medical Information Technology Inc. (MEDITECH), of Westwood, MA, to serve its large and diverse health care network. The computing environment at UCDMC is diverse, comprised of many stand-alone systems. The MEDITECH portion of the system is comprised of a suite of core LIS applications, including: laboratory, blood bank, microbiology and anatomical pathology, plus several other integrated non-LIS applications such as pharmacy, patient care inquiry (electronic medical record) and general ledger applications. With all the changes taking place in the health care industry and pathology in particular, we work closely with our vendor to identify issues and seek solutions. By doing this we have ensured that the system will continue to work for us and enable us to meet our needs, including patients’ rights, regulatory, reporting and reimbursement needs.
Issues of patients’ rights are coming under close scrutiny because of the regulations set up in the Health Insurance Portability and Accountability Act (HIPAA). The act calls upon organizations to guarantee the rights of patients by keeping their health information private, especially in the case of electronic medical records. To accomplish this, health care organizations are calling upon their vendors to install an impregnable series of checks and balances in their information systems. They expect their vendors to understand and implement the latest encryption and firewall programs and to provide consultation relative to the installation of these functions.
Although privacy of the patients’ results and health information appears relatively straight-forward to accomplish, the various types of requests and demands for information make the scope of the task daunting. While a “keep out the intruders” security system may be sufficient to protect data from outside sources, this type of system does not address many of the complex situations encountered on a daily basis. Laboratories must break down their security concerns beyond just the patient/client privacy issue. They must address their clients on an inpatient vs. outpatient basis and deal with issues surrounding the privacy of the institution’s own employees, including laboratory employees.
This is particularly difficult for academic teaching facilities where the number of caregivers is extensive. Interns and residents present information to attending physicians during rounds, physicians consult with specialists, and interns and residents change rotations frequently during the course of treatment for any individual patient. Because of these concerns, assigning a specific caregiver to a patient requires constant management.
Identifying the primary care giver responsible for releasing information is another concern. In the case of inpatients, organizations may grant access to a wider scope of “need-to-know” caregivers, usually identified by title or function rather than name. In the outpatient setting, the primary care provider can often be designated as the caregiver to receive and release data; however, in a busy practice the office staff often does the review and collection of data for the physician. Therefore, to provide quality care, the information system must be able to identify employees and notify the primary care giver of pending results to be reviewed while still protecting the privacy of the patient. In the laboratory, this process becomes even more complex because the staff must have access to the result fields in the applications to complete and verify their work. For this reason, the lab must ensure that their LIS is designed to limit access to the records of their own employees.
Although much of the patients’ rights issues deal with keeping records private, there is also a growing issue of increased access in terms of who can view a patient’s record. This scope of access has begun to grow beyond the medical field. Three factors HIPAA, the Institute of Medicine Report on Quality Care and the growing use of the Internet are encouraging and enabling patients, outpatients in particular, to become more involved in their own care. This means labs will be granting people outside of their organizations access to their LIS results. While this access ostensibly will be for viewing their own records and lab results, the individual health care organizations will need to prevent browsing within their systems. This will need to be addressed directly within the LIS by employing some form of high-level but useable encryption. Furthermore, if the laboratory chooses to present the results through an Internet ASP provider, the ability of the laboratory to ensure correctness of data passed and access control as defined in HIPAA will be critical.
Regulations and Reporting
Privacy issues are not the only place where the government has increased its stringency. Regulations governing the process and reporting of testing procedures have always been an area of concern for laboratories; organizations have relied upon their LIS vendors to keep up with these changes and implement within the timeframes designated or sooner.
Every lab application has its own share of regulations and sets of rules for reporting, for example, blood bank applications, which the FDA regulates. This month, the FDA is scheduled to institute a new reporting structure for reporting level 1, 2 and 3 sentinel events. Consequently, monitors have to be developed, reports need to be generated for internal use and documentation for reporting required items to the FDA must be established. Therefore, the events have to be verifiable within the LIS so those monitors can easily check the work. The ideal way to address these would be to integrate within the LIS an efficient system of checks, balances, flags and warning signs, which would result in an automatic report. This report could be generated for one sentinel event or be printed as part of an overall quality management report with incorporated statistics.
The pending implementation of the ISBT 128 barcode symbology will also radically change the way that units are viewed in the system. A standardized format will be used for labeling all blood and blood products. The ability of a system to both print the new label format and inventory products efficiently and logically will be crucial. The advent of the electronic crossmatch has received high acclaim for its ability to provide product faster and reduce expenses relative to the crossmatch process. However, the introduction of the electronic crossmatch represents a considerable commitment of time and resources on the part of the vendor and institution, as both must apply and receive FDA approval. Many newer systems have already considered these needs and have built them into their products, which reflects their understanding of the market and the needs of their users.
Organizations with long-standing LIS systems, however, may prefer to work with their vendors to address these needs in an effort to retain continuity in their system. This may result in other changes to the system as well. For example, UCDMC is currently working with MEDITECH to make its blood bank application more user-friendly.
The extensive development of equipment that can perform tests at the bedside also presents significant challenges for LIS systems. This environment requires wireless, handheld equipment to enter data both manually and by electronic transfer. It is also necessary to establish a method for transferring data to the LIS where graphs can be used to follow work performed not only by the inpatient nursing units, but also by the laboratories and outpatient care providers. The jury is still out on whether the nursing or laboratory staffs will do this work, or whether a combination of the two will be used. Nevertheless, a permanent record is essential to support actions taken and a robust data transfer system that is both convenient and easy to use is needed.
The cost of medical care has come under increased scrutiny over the past 10 years from the federal government and laboratories have come under particularly close observation for their adherence to regulations and the rules of medical necessity. As such, the collection of information to ensure that all performed tests are billed and reimbursed to the appropriate level is critical to the continued operations of the laboratory. The current issue here is the identification of the medical necessity for the procedure. Labs need a system of flags at the order entry point that will identify tests that require an ABN (Advance Beneficiary Notification), physician privileges and medical necessity checks (the system should also be able to print out the ABN at the time the order is placed and on demand). As the rules concerning which ICD-9 codes are appropriate for a given procedure are developed, the ability of this system to warn users of inappropriate or incomplete codes is essential to ensure billing is accomplished.
Today and Tomorrow
Labs are progressive by nature because their entire history has been one of constant change. Changes in how they are regulated, how they report information and how they protect the privacy of their test information is subject to constant review by not only their own organizations but by the government as well. Since the lab environment is in a frequent state of change, an effective LIS is one that is changing at a similar pace.
A static LIS is a useless LIS. Therefore, both lab and LIS vendor alike need to drive changes to the system at an ever increasing pace to keep up with the changing environment.
Martha Kunkel is assistant manager, LIS Systems, University of California-Davis Laboratories.
The Four R’s in LIS Selection