Medicolegal liability and clinical software.

As does any other technology, computer software opens up new possibilities, but also creates new obligations in using it properly -- and legal vulnerabilities for failing to do so. Applying it to the clinical care of residents, as per OBRA documentation, is an obvious case in point.

Recently NURSING HOMES Editor Richard L. Peck asked two attorneys from the Chicago-based firm of Gordon & Glickson, PC, to address the specific liabilities that might be posed by use of clinical software in the nursing home. This widely-known firm provides a wide concentration in the development, financing, distribution, licensing and suport of software and database and information products and services. The firm has experience in handling matters for health care providers nationwide, and has offered many articles and presentations nationally and internationally. Its philosophy is that, for all the speed, accuracy and organization that computers provide, they must be used as carefully as any other health care technology, as attorneys Gordon and McKenzie explained.

Peck: Has there been much legal activity as yet relating to the use of clinical software in nursing facilities?

Gordon: Though there have been information technology cases in the hospital field, nursing homes are a relative newcomer to this, and there are few cases as yet. The major area of legal activity right now may be the regulatory one. Information systems are not as yet regulated by the Federal government, but that could change soon.

McKenzie: The Federal government has given many indications of being interested in developing regulations for clinical software. This is something to watch for in 1993.

Gordon: As for legal liability, however, the same concerns apply in the nursing home as in the hospital. A facility can be held liable in three major areas: mistreatment of patients or residents, failure to comply with regulations, and violations of confidentiality. None of this is new to nursing homes, but relying on new technology to avoid these risks raises serious issues and new considerations for them.

Peck: What are some of these concerns?

Gordon: First of all, if the new information system is inadequate in any way, the nursing home bears the initial responsibility. The nursing home is obligated to comply with regulations -- in this case, OBRA '87 -- and if it picks the wrong tools to do this, or if it uses the tools improperly, the nursing home is legally responsible.

Similarly, if the system performs poorly, or if confidentiality is violated during its use, the nursing home has the initial risk.

McKenzie: Even if if turns out that the computer software vendor is 100% to blame, it is unlikely that the injured resident w.11 know this, and will probably consider suing the nursing home in the first instance.

Gordon: There is nothing in the law, as it stands today, that will relieve nursing homes of their responsibility and shift that responsibility to even the worst of vendor;. This is why adopting computerized clinical software for use in the nursing home involves some very important decision making, both in procurement and operationally. It is incumbent on the nursing. home to be a prudent buyer and operator of this equipment. If due caution is taken, the risks won't disappear, but they will be contained, and the odds of avoiding legal liability will improve.

McKenzie: And part of prudent purchasing involves deciding how to allocate the risks with the vendor. For example, liability insurance should be taken into consideration. The nursing home should be fully aware of the extent of its malpractice coverage and the degree to which it covers software-related liabilities. Vendors also have errors and omissions insurance, and the extent of this insurance should be discussed. Once the amount of insurance of both parties is understood, the nursing home and vendor should develop a contract specifying how the risks should be allocated between them.

Peck: Could you give another example of factors to take into account?

Gordon: Having represented both sides in these situations, we can tell you about one oversight that is very commonly made: what happens when regulations change. Very frequently this consideration is simply overlooked. A vendor's simply stating, "We will keep you updated" really isn't sufficient. There is the question of what updating means and who will absorb the cost for this. Many vendors may offer this as part of their service agreement, for which, of course, the nursing home pays. Or the updating arrangment may be worked out by the vendor and the nursing home on a case-by-case basis, depending on what seems most suitable for both parties. The point is that both parties should be very clear on this.

Peck: What are some of the concerns that arise in maintaining confidentiality of residents' clinical information?

Gordon: It is certain that no vendor of nursing home software can afford to neglect building confidentiality safeguards into the system. And the nursing home can monitor for this by asking specific questions, such as: How is patient information shielded for need-to-know access? Who will have access? Nursing staff will have access, of course, but so might front office personnel and perhaps even other facilities that have been networked together for reporting purposes, as with a nursing home chain. Another important question is, how can we assure continuing accuracy of the information?

All of these have to be thought through and worked out in implementing the system. Obviously, the assistance offered by the vendor in this matter will be important in deciding whether or not you want a long-term relationship with that vendor.

McKenzie: In the future we can expect confidentiality safeguards to become even more important, due to the anticipated increase in the use of bedside terminals.

Peck: What about a major consideration in nursing homes, with their high turnover rates -- the issue of staff training?

Gordon: Again, maintaining staff competence with technology is the nursing home's legal responsibility in the first instance. But they should scrutinize vendors' programs for ease-of-use, as well as regular availability of training programs or other ongoing support in this area.

McKenzie: The nursing home should also pay close attention to the documentation the vendor provides -- the training manuals, the service manuals, and so forth. To do this, the nursing home must ask some very specific questions. For example, how many copies of the documentation are provided? Is the documentation written in a form that the staff can readily comprehend? How often is the documentation updated?

Peck: Any final thoughts on the selection of a software vendor?

McKenzie: The key to the successful procurement of software in the nursing home is to select the proper team to get involved. The team should include nursing home staff members who thoroughly understand the business, outside consultants to aid in the selection of the right system for the particular nursing home, and experienced attorneys in this field. Too often nursing homes attempt to do it all on their own to save costs, or else don't know how to select consultants and attorneys who are well-credentialed in this very specialized area. Our firm has routinely represented users and vendors not only during the procurement process, but after the deal has gone bad. Our experience has been that when both parties are well-represented during the procurement process, we are less likely to get involved in a substantial dispute later on.