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AIDS: how to protect your lab on legal issues.

Here's the evolving law on such matters as transfusion-transmitted AIDS, false positives and negatives, disclosure of test results, protection of the health care staff, and employees who refuse to work with AIDS patients.

The author is senior partner of Griffith and Burr, a Philadelphia law firm specializing in health care law and medical malpractice cases This article is adapted from his presentation at the MLO '88 Conference on Laboratory Management

Another health care epidemic is traceable to the AIDS virus: a wave of malpractice and other lawsuits. But laboratory and hospital managers can do much to protect themselves against legal action for negligence, libel and slander, failure to obtain consent, breach of confidentiality, failure to warn, or failure to maintain a safe workplace.

First let's consider the problem of mistakenly supplying HIV-positive blood units for transfusion. All but a few states have adopted laws classifying the provision of blood and blood products as a service, not as the sale of a product. Thus hospitals and blood banks involved in the transfusion of contaminated blood can be held liable only for negligence, which requires more stringent proof than product (or strict) liability.

Under negligence theory, the plaintiff must prove that the defendant acted unreasonably or failed to meet a recognized standard of care. Under product liability law, the plaintiff must show simply that the defendant sold a product possessing a defect that made it unreasonably dangerous.

Several cases have already been filed challenging the immunity from product liability suits. The theory in these suits is that the state laws were passed to protect hospitals from strict liability for hepatitis transmission; at the time, legislatures did not foresee that the bills would be used to grant immunity from strict liability for an incurable, fatal condition like AIDS. In the three cases that have reached the appellate courts, the immunity contained in state statutes was upheld.

In order to prove negligence in the identification of donors or recipients, or in the collection, labeling, or testing of specimens, the plaintiff must demonstrate that there was a standard of care, that there was a breach of that standard of care, that an injury resulted, and as a consequence, that damages should be paid.

Here are a few questions about lab procedures that may be asked by the plaintiff's lawyer: Was AIDS testing performed appropriately? Can the test meet a legal standard of reliability'? Is the test sufficiently reliable to justify social embarrassment and humiliation from a positive result, loss of job, loss of standing in a community, failure to get a promotion, or denial of health insurance?

One way to show that care was lacking is to refer to the standards of respected agencies like the Joint Commission on Accreditation of Healthcare Organizations, as well as state regulations. These are the rules against which conduct will be measured deficient. It is also very important for blood banks and other health care providers to show compliance with the licensing or accrediting requirements that they themselves have elected to be bound by.

It goes without saying that laboratory and blood bank administrators should be familiar with their state's statutes on blood banking requirements for personnel and record keeping. For example, the Blood Bank Act for the Commonwealth of Pennsylvania is a complicated set of regulations and standards that require certain types of facilities and proficiency evaluations of test procedures. The state has spelled out standards for collecting, processing, storing, and distributing blood. There are regulations for screening, rejecting, and identifying donors, as well as qualifications that the blood bank director and personnel must possess.

An initial encounter with state regulations may furnish surprises. For example, some health departments have even set guidelines for the location of blood banks in order to steer clear of areas with higher than average transmission levels of hepatitis and other diseases through blood transfusions.

Another way to prove a standard of care is through testimony from an expert witness. I have learned in my 23 years of representing health care professionals that there is no such thing as one standard of care for a particular disease process, because there is no uniform approach to treatment. Unfortunately, however, the dpor is always open for an expert witness to declare flatly that "This was the standard," or "We always do this in our laboratory."

Sometimes expert witnesses present conflicting testimony. For example, an expert witness may express a belief that a laboratory with properly measured reagents and a properly calibrated instrument should not have false-negative and false-positive rates above x per cent. A second witness may testify: "Nobody could possibly meet that standard. This is what a lab is able to do, and no more than this." The second witness names a different percentage.

The difference then becomes a matter for a jury to decide. The jurors will say which, if either, of the two standards they will accept as a reasonable standard against which to measure the facts of the specific case. The jury has a powerful position in determining whether or not the standard is reasonable, and if it is found to be reasonable, whether there was a departure from the standard.

The timing of a transfusion of blood infected with human immunodeficiency virus (HIV) can be critical in a negligence suit. Commercial AIDS screening tests became available in early March 1985. Abbott, the first company to win Food and Drug Administration approval, began shipping HIV antibody test kits on Saturday, March 2, 1985. The second company won FDA approval five days later.

A man who claimed he contracted AIDS from a transfusion of blood shipped to a hospital on March 6, 1985, recently was awarded $3.9 million by a jury that found the blood supplier negligent for not screening donations. The defendant blood center had begun screening its units one day after shipping the blood involved in the litigation.

On the other hand, if a suit claims that HIV-infected blood was transfused before commercial screening tests were available, the patient's lawyer might argue that the transfusion was unnecessary-that the patient was needlessly exposed to the risk of a serious, life-threatening disease when in the good practice of medicine, the doctor should never have ordered a transfusion at all,

The specific argument might go: "The patient was healthy and had good bone marrow that could have regenerated an acceptable level of hemoglobin after surgery. The patient should have received Ringer's lactate solution instead of blood."

Another kind of suit looming on the horizon is a corporate liability case against a hospital or other health care provider in which a patient who has not been transfused is infected with HIV. In such a case, the hospital could be held liable for the spread of AIDS to non-AIDS patients if it failed to maintain proper preventive standards.

Within the next year, we may see several of these cases from patients undergoing dialysis for endstage renal disease. The difficulty in keeping the filtration process infection-free is a ticking time bomb. Eventually, one or more individuals who are not at risk of AIDS and who have never had a transfusion will probably come down with a case of AIDS that is traceable to dialysis.

Some legal problems can arise from the reliability and accuracy of the testing itself. Say an AIDS test is perfon-ned and the patient receives a positive result that is eventually revealed to be false. Imputing that a disease-free individual is harboring the AIDS virus may be considered libel and slander.

Such cases originally arose when there was great concern about syphilis and gonorrhea. The case law that came out of false positives and false negatives for those diseases is important today in light of the public hysteria over AIDS. If you inform a patient that he or she has AIDS, and the patient is able to prove that the test was unreliable or improperly performed, assessed damages may amount to hundreds of thousands of dollars.

The Federal Government deems AIDS a handicap rather than a communicable disease. For that reason, any institution that receives Federal funding, such as Medicare or Medicaid money, cannot deny AIDS patients access to appropriate medical treatment and care.

Nor can hospitals routinely test patients for exposure to HIV without their knowledge and consent. Even if a physician strongly suspects that a patient is a member of a high-risk group, no HIV antibody test can be ordered without the patient's consent. Covert testing is considered an invasion of privacy.

Result reporting is another major AIDS testing issue. A confirmed positive HIV antibody result should be reported to the physician, who in turn should inform the patient and public health authorities, especially if state law so requires. In my opinion, health care employees and other individuals at risk because of their contact or association with the patient should also be informed. Until a confirmatory test is performed, however, I don't think the lab or institution has a responsibility to report a positive result to anyone other than the patient's physician.

Hospital administration must devise a standard protocol, explicitly describing the steps the laboratory and the physician should take when a patient has a confirmed positive HIV result. The protocol should specify what level of information is to be revealed, to whom this information can be communicated, and what options are available to employees working with the patient.

Don't be afraid to ask questions where the release of information is concerned. If a laboratory gets a vial of blood from the ABC Insurance Company with an attached patient consent form for HIV testing that says the results can be turned over to ABC Insurance, the lab can follow through within the scope of the granted permission.

But the laboratory should be on guard if it gets a vial of blood that says only, "Report the results of the HIV test to ABC Insurance." If the lab proceeds to communicate sensitive and confidential 'information to the insurance company on the basis of this inadequate consent, it will be making a monumental error.

If your state has a public health reporting statute for HIV data, obviously your lab must report a positive result to the proper agency. If the statute indicates that it Is a physician's responsibility to report (i.e., the laboratory medical director's responsibility), that does not remove the hospital's liability for failure to communicate the information.

A smart physician will figure out how to make the patient with a confirmed positive test result understand that certain people in the sphere of the patient's life must also be told about the test result. The physician must convince the individual that this disclosure is appropriate and necessary.

Certainly a spouse or a regular sex partner in an ongoing relationship would have to be told. If that person is in a direct line of danger from the HIV-contaminated partner, I think the information must be passed on.

If the patient refuses to divulge the information, then the physician knows that the patient is aware of the risk and will continue to expose someone else to that risk. Under these circumstances, it is clear that the physician must contact the person at risk. Such an action could cause the patient to become angry, to report the physician to a licensing bureau, or to sue for breach of confidentiality.

The physician could face a much larger problem by keeping silent. Say the patient is a male, and his wife, who is not warned not only contracts the disease but also transmits it to a child she bears. Her suit against the physician could have a price tag of between seven and nine figures. If I were the doctor, I would rather be sued for nickels and dimes than for millions.

I think it is appropriate for those on the health care staff who might be affected to know that a patient is suspected of carrying the AIDS virus. Even if all that is known about a patient is that he or she has come in for AIDS testing, prudence suggests that the fact be noted, but it is not incumbent on the physician director of the laboratory to notify everyone on the lab staff.

Several suits have been filed against hospitals and physicians by nurses and medical technicians who were not warned that a particular patient may have had AIDS, A nurse has sued a physician I represent. This physician performed a colonoscopic examination on a patient he suspected was infected with HIV. To protect the patient, the physician did not communicate his suspicions to the staff. The staff in any event was supposed to take detailed precautions when cleaning equipment that had been used in the examination. The nurse, who chose not to follow the cleaning guidelines, sued after learning that the patient had AIDS.

It has been two or three years since the incident, and the nurse still has not seroconverted. She wants compensation for her mental torment. The defense against her case is that she created the risk to herself by failing to take the prescribed precautions; the risk did not arise because of information that the physician withheld.

Every hospital must decide what to do when an employee refuses to work with a patient or specimens because of the AIDS risk. The policy on refusal to work--just like a policy about reporting test results-should be made absolutely clear to all laboratory and nursing employees.

Administration in an understaffed hospital may decide to take no action against lab employees who refuse to process certain specimens, as long as others are willing to do the work. Elsewhere, hospital administrators may require all lab employees to accept every specimen directed to them. Policies will vary according to hospital circumstances and administrators' preferences, and they cannot be standardized nationally. Both approaches are valid.

If employees are satisfied that their laboratory's guidelines will keep them safe, they should continue to work there. If they confess to unhappiness or nervousness, they should make arrangements to work somewhere else, in my opinion.

Who is responsible in general for educating the laboratory staff about protection from AIDS? It is up to the director of laboratories to see that those who work in his or her environment are told what the risks are and how to protect themselves. Today most laboratories use the Centers for Disease Control recommendations for preventing HIV transmission as their safety blueprint.

No hospital policy will prevail in court if it is not in the mainstream of acceptable procedures. A court, however, has the right to consider whether the national standards themselves are de cient.

If a laboratory employee is harmed and can prove that this harm could have been prevented by hospital or laboratory adherence to CDC guidelines, the employee has the fundamental makings of a persuasive case. If your laboratory follows protocol B, but A is used by many other laboratories and could have prevented harm to the employee who has sued, a jury will determine whether the failure to adopt protocol A was negligent.

There is, unfortunately, the potential for litigation between physicians and individuals they work with on a day-to-day basis. A basic question is: Will employees who become infected on the job receive adequate damages in the form of workers' compensation, or will they instead sue laboratory physicians?

Workers' compensation is a remedy between employer and employee . If pathologists or physician lab directors are not salaried employees of the hospital, they would not be fellow employees of technologists who have been infected on the job. And if physicians are not considered fellow employees, they are not entitled to the defense that the only remedy is workers' compensation.

These are some of the many legal issues born of the AIDS epidemic. Each institution should have some form of legal counsel available to its management staff. And until clear legal guidelines are established, arm yourself with the protocols set forth by your institution and a complete knowledge of the regulations and standards of health care agencies.
COPYRIGHT 1989 Nelson Publishing
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Copyright 1989 Gale, Cengage Learning. All rights reserved.

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Author:Griffith, James L.
Publication:Medical Laboratory Observer
Date:Feb 1, 1989
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