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How to defuse legal dynamite in the lab.

How to defuse legal dynamite in the lab

During my 20 years of defending health care providers in thousands of malpractice cases, I do not recall one instance where a laboratory was sued because it performed a test incorrectly. There were, however, many lawsuits involving laboratories. They usually got themselves in trouble over faulty communication and documentation.

Here's an example. A young child with a history of vomiting over a period of 72 hours needed emergency surgery to remove an intestinal obstruction due to intussusception. The surgeon ordered Stat electrolytes and later claimed he was advised the tests were normal. During surgery, the child went into uncontrolled convulsions for one and a half hours; this resulted in severe brain damage.

The family sued the hospital and the surgeon of millions of dollars. It turned out that the electrolytes had not been normal. Several of them, particularly the sodium, were dangerously low, and there was a cause-and effect relationship between the status of the child before surgery and the seizures. The laboratory maintained it performed the testing Stat and reported the grossly abnormal results Stat, by telephone. But the issue was: to whom? Where was the documentation?

The operating room nurse testified that there was no such call to the OR from the lab. The surgeon claimed the nurses told him the tests were normal, and that he would never have proceeded without that clearance from the laboratory.

Jurors in this case, interviewed after a seven-figure settlement was reached, were appalled that care of the child was handled in such a slipshod manner. They found it hard to believe that the laboratory could not document who telephoned with the critical values, when, and to whom the information was given--or that the physician had not made a chart notation about the lab results.

The laboratory has a responsibility to make sure critical test results get to the appropriate person. Calling them in to the high school girl at the doctor's answering service on Saturday morning is not communicating to the doctor-- neither is reporting to whoever happens to answer the phone at the nurse's station. The protocol for communicating test data should cover what to do if the attending physician can't be reached.

Lawsuits arise when communication breaks down and something critical to a patient's care is lost. That communication may involve a clerk logging in a specimen, a technologist calling results to a nurse on the floor, or a nurse relaying data to a physician. In a lawsuit, the ultimate question will be: Was a link in that chain of communication broken? Exactly where the break occurred determines who is liable.

Laboratory procedures must insure that communication is not only effective but also properly documented. How many laboratory slips never make it to the patient's chart? If something is supposed to be in the chart and is not, a jury may infer that it was not done.

A medium-size hospital laboratory may perform 700 to 1,000 procedures a day. Staff members cannot be expected to remember whom they called with a certain result when a lawsuit is filed two and a half years later. However, if a medical technologist or clerk simply transmits the information to the appropriate person and notes, "Results given to Nurse Jones (time and date),' the laboratory has met its obligation and is protected.

That requires just a quick notation for each call, not reams of supporting paperwork. All results should be documented, but it's really only the abnormal ones that are crucial in terms of verifying communication, because they hold the potential for serious harm to the patient.

To reinforce a sense of how important it is to follow procedures, supervisors must constantly remind staff members that they are involved in the clinical practice of medicine. The specimens do not come from laboratory rats; these fluids and tissues have been removed from people just like us. Analyzing such materials is as much a part of treatment as drug therapy or surgery.

The goal of medicine is to make a correct diagnosis and, based on that, to initiate appropriate treatment. Much of the physician's diagnostic armamentarium comes out of the laboratory. A foul-up there could delay the diagnosis or cause a false one to be made, either of which can harm the patient.

Laboratory directors should conduct regularly scheduled review sessions to go over mistakes, whether or not they resulted in lawsuits. Citing specific cases reminds laboratorians of the consequences of their actions. It can also show the director whether protocols are adequate and whether they are being followed. Lectures on the clinical purpose of laboratory tests--what conditions they reveal, why a critical value is dangerous to the patient--are another way to heighten awareness of the laboratory's integral role in patient care.

Let's consider other communication problems. One case involved a patient who went to an outpatient surgical center to have a suspicious-looking mole removed from her back. She was 18 years old and very upset because she thought it was cancerous. The surgeon performed the procedure and sent her home. A week later she called to find out why she had not heard the results of the biopsy, and the investigation began.

The surgeon said he left the specimen where the operating room nurses normally pick it up, and he filled out the request slip for the pathology laboratory. The laboratory had the slip but not the specimen; personnel there had realized a specimen was missing the previous week, but did not inform the surgeon.

Somewhere between the outpatient surgery department and the laboratory, a communication failure occurred. The patient, who started out absolutely convinced she had cancer, had to come back in for a second procedure. Even though there was no evidence of cancer in the tissue section, she was more convinced than ever of a malignancy. Her reaction may seem ridiculous, but she had no problem finding a psychiatrist to testify that the fear of cancer is a recognized phenomenon.

When a specimen arrives in the laboratory, it should be logged in, given a number, and assigned to a particular technologist. Laboratories often will be blamed for losing a specimen unless they have a system that can prove that they never received the specimen. Clerks should be made aware of their role as the first line of legal defense in the laboratory.

Of course, the substance of communication is as important as the chain of communication. Words used to report a result can either hinder or help a physician's diagnosis, and can either make the laboratory legally vulnerable or protect it.

Suppose a microbiology technologist thinks that what may be a pathogen is really a laboratory contaminant. There is a significant difference between reporting "suspected lab contaminant-- suggest repeat study' and "lab contaminant.' The first puts the diagnostic burden on the attending physician, whereas the second makes an absolute, positive statement that may prevent the physician from considering the possibility that the organism is not a contaminant.

Radiologists' reports are classically self-protective: "suspected mass,' "cannot determine whether this is active or chronic tuberculosis,' "cannot exclude the possibility of outer lobe carcinoma of the lung,' "suggest follow-up studies.' These phrases may sound wishy-washy, but they are often more accurate than simply writing something like: "This is TB.' Laboratorians have to understand that it is all right to say they are not sure.

A Pennsylvania case, Hammel v. Bashline, went up to the state supreme court three times and finally ended up with a test for negligence: If a health care professional's conduct increases the risk of harm, it is negligent. In this case, a man went to an emergency room with chest pains. The only working electrocardiograph in the hospital was locked up and the doctor didn't have the key. He told the patient to go home. The patient's chest pains were getting worse, so he tried to go to another hospital, 40 miles away. He never made it. The failure to have a working electrocardiograph increased the risk of harm because the patient's treatment was delayed.

Failure to perform a laboratory test appropriately or to communicate results promptly in a reliable manner increases the risk of harm. If a physician orders a test and the analyzer isn't functioning, the laboratory director should call and ask whether the physician is willing to wait 24 hours (or however long) until the instrument is repaired. The director can't make that decision alone. The physician may reply, "This is an emergency. I want the test sent out to another lab.'

So far we have been discussing communication between the laboratory and the physician, but the lab has another area of communication responsibility: public reporting. Many laboratorians are unaware of the reporting requirements for communicable or other diseases in their state--and that the penalty for violation in many states is a fine or even a prison sentence.

Clinical laboratories ran blood lead tests on workers in a Pennsylvania plant month after month from 1946 to 1981, when the plant shut down. The labs found levels in excess of 100 g/dl. They reported this to the plant physicians, who informed the plant managers, but nothing else was done. No one ever told the state or the employees.

Sixty legal cases arose, all of them settled before a jury verdict. Jurors indicated afterward, however, that they would have assessed heavy damages against the laboratories had the cases gone to them for a verdict. It wasn't enough for the laboratories to argue that they had discharged their obligation by reporting the test results to the plant physicians. Jurors pointed out that the laboratories had not reported to the state despite the statutes requiring such reporting. They also noted that the laboratories had been reporting grossly elevated results for many years without seeing any improvement, yet the labs took no action.

The Pennsylvania reporting statute is directed at any person in charge of a laboratory where examination of a specimen yields evidence, significant from a public health standpoint, of the presence of any of the following 29 disease categories: amebiasis, anthrax, botulism, brucellosis, cholera, diphtheria infections giardiasis, gonococcal infoctions, viral hepatitis A and B, hypothy-roidism in infants up to 24 months old, histoplasmosis, lead poisoning, Legionnaires' disease, leptospirosis, lymphogranuloma venereum, malaria, meningococcal isolations, phenylketonuria, plague, psittacosis, rickettsial infections (including Rocky Mountain spotted fever), salmonella, shigella, syphilis, trichinosis, tuberculosis, tularemia, typhoid, and certain other viral infections (vaccine-preventable diseases, arboviruses, and respiratory viruses).

The findings must be reported not later than the next working day. If the technologist on duty at night detects or isolates one of these reportable diseases, he or she has 24 hours to report it, or the laboratory can be held liable.

To make sure such requirements are followed, a list of findings reportable to outside agencies should be posted prominently in the laboratory. The laboratory manual should contain the list and the kind of reporting each disease or finding requires, with the name, address, and phone number of the appropriate agency to receive the report.

Some situations may not fit technically into reporting statutes but may still place upon the laboratory an obligation to notify additional parties. One laboratory reported findings suggestive of AIDS to the attending physician, but the nurses on the floor were not notified until three days later A nurse has now filed a lawsuit, stating that if she'd known the patient had AIDS, she would not have worked with him and would have insisted upon quarantine measures.

To keep abreast of new or updated reporting requirements, laboratories and their counsel should review publications and statements issued by state health departments and Federal agencies, such as the Centers for Disease Control and the Occupational Safety and Health Administration.

On occasion, laboratory management may need advice to determine how widely certain information must be disseminated. This might come from hospital administration, legal counsel, or an outside agency. If the hospital's counsel isn't very knowledgeable about liability, a second opinion can be sought from a firm specializing in health law.

Reporting regulations raise the issues of patient confidentiality and right of privacy. However, the courts have consistently ruled that protecting the innocent public overrides the doctor-patient relationship and privacy considerations. If a laboratory reports information that has broad health implications and in so doing violates a patient's right of privacy, the person may sue, and a court may award $5,000 or $10,000 in damages for embarrassment or inconvenience. On the other hand, if the laboratory conceals a major health threat to the patient's family or co-workers, the verdict could be in the millions. Laboratory management must step back and weigh risks, benefits, and alternatives.

Assessment of risks is the basis of the doctrine of informed consent, another area of legal liability. Procedures to obtain specimens, from a spinal tap to simply drawing blood, carry with them varying degrees of danger. Before tests are undertaken, the patient should understand the risks and agree to accept them.

Maintaining an effective quality assurance program is an essential in avoiding legal trouble. Workloads must be evenly divided and reasonable. The appropriate personnel, instruments, and supplies should be available. If a laboratory tries to take on more volume than its staffing can handle, quality will suffer.

Don't try to perform a test without being confident in the accuracy of the methodology; if another lab in the area can do it better, send it out. In front of a jury, there is no way to defend decisions that make patient safety take a back seat to budget considerations or an institution's "pride.'

There was a rampant staph problem in one hospital nursery, but administration kept it quiet. Obstetricians continued to admit mothers and their babies to the unit, and three children contracted severe infections, resulting in disabling injuries. The parents sued the hospital and the obstetricians.

In court, all the obstetricians reported that they had privileges at other hospitals. Even if they did not have such privileges, they stated that they would have admitted the mothers to another institution had the staph risk been disclosed although the referral might have meant giving up care of the patients to another doctor.

The laboratory's first obligation in this case was not to keep up the occupancy rate of the hospital. Saving a newborn from brain damage or other serious consequences clearly takes precedence. Laboratorians cannot lose sight of the fact that they participate in the clinical care of patients. Their responsibility to patients goes beyond correctly processing individual test results and reporting them promptly, although that is of course a very important function.

Vigilance, quality control, reporting, and documentation--all of these factors will ultimately have an impact on the quality of testing and on the clinical management of patients by the physicians who rely on the laboratory, and rely on it not just for the accuracy of results, but also for honest, effective communication.

"Had I known,' a regretful physician may say, "I would have repeated the test.' . . . "Had I known, I would have sent the patient to another institution.' . . . "Had I known, I would never have given him that drug or never have let her go home.' . . .

"Had they communicated with me. . .'
COPYRIGHT 1986 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1986 Gale, Cengage Learning. All rights reserved.

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Author:Griffith, James L.
Publication:Medical Laboratory Observer
Date:Nov 1, 1986
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