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September 2007

Q: Our flow cytometry lab does the technical work for another smaller group. They issue a report and charge the professional component. This group does not have a hematopathologist. My group has several fellowship-trained and subspecialty hematology-boarded MDs who do the QC for the flow lab and review the flow reports. We have seen some cases that have been misinterpreted by the non-HP pathologists in that group and have real doubts about their competence in flow cytometry. Our discussing this with the other group displeased them. I am nervous about my liability and their patients receiving incorrect interpretations. What liability could we incur by doing QC on flow reports that we do not interpret?

A. This question raises a number of important issues. I will address each of them. However, I must state that this response is not intended to substitute for advice that the author of this question should obtain from her group’s own lawyer.

Liability issues. Initially, doing the technical work for another lab that has misinterpreted flow reports should not, without more, make the technical component lab liable for the negligence of the other lab. It is quite common for a lab to perform the technical component of all sorts of tests—not just flow cytometry—that are interpreted by other pathologists, clinicians, or non-physician practitioners. Assuming that the technical component lab does its work properly, it should generally not be held responsible for any malpractice in the professional component.

What differentiates the situation described in this question from the more common situation is that, in the words of the author of the question, the physicians at the technical component lab “have seen some cases that have been misinterpreted by the non-HP pathologists who are performing the professional component.” These physicians “have real doubts” about the “competence in flow cytometry” of the non-HP pathologists. On these facts, I believe that the lab that is doing the technical component is correct to be concerned about its potential liability.

Two physicians who are treating the same patient concurrently can divide the labor as the circumstances warrant. However, it has long been settled that “each in serving with the other is rightly held answerable not only for his own negligence but also for any wrongful act or omission of the other which he observed and permitted to continue without objection.” (See, for example, Beauchamp v. Davis, 217 S.W. 2d 822, 825 [Ky. 1949].) To be sure, this concept has traditionally been invoked outside the pathology context. However, the same principle would seem to apply where one pathology group has reviewed the professional services of another group for which it has performed the technical component.

Of course, in the situation described in the question, the technical component lab did make an objection regarding the practice of the smaller lab. But according to the question, “Our discussing this with the other group displeased them.” In my judgment, merely making an objection about a practice—and then permitting the practice to continue as before—will not exonerate the party that made the objection.

Indeed, this situation is somewhat analogous to referring a patient to a physician who was known to have been incompetent. That act would expose the referring party to liability because the referring party negligently put the patient in a position in which the patient could be injured. (See, for example, Greenwell v. Aztar Indian Gaming Corp., 268 F3d 486, 490 [7th Cir. 2001].) Similarly, continuing to perform technical component services for a group known to have questionable diagnostic abilities could be said to be negligently allowing the patient to be placed in harm’s way.

Whether the technical component lab would actually be found liable on the facts presented would be for a jury to determine. That lab would argue that it had an insufficient basis for concluding that there was a systemic problem with the smaller lab. It would also argue that misinterpretation of the flow reports was not the proximate cause of any injury to the patient. In this connection, it would point out that flow cytometry is an ancillary procedure and that any lymphoma or leukemia would have been diagnosed in conjunction with morphologic and immunohistochemical findings—not on the basis of flow results alone.

Ultimately, it is possible that these and other arguments would prevail. However, it must be recognized that a patient whose lymphoma or leukemia was misdiagnosed or belatedly diagnosed would be a very sympathetic plaintiff. The jury would not like the fact that the technical component lab was apparently aware that some cases had been misinterpreted by the smaller lab but continued to perform technical component services for that lab even after its warnings went unheeded. While jury behavior can never be predicted with certainty, it seems quite foreseeable that the jury might impose liability on all concerned.

In this connection, it would not surprise me if a good plaintiff’s malpractice lawyer would invoke 42 C.F.R. §493.1291(a) against the technical component lab. That provision of the CLIA regulations requires laboratories to maintain an “adequate manual or electronic system…to ensure test results…are accurately and reliably sent from the point of entry to final report destination.” Read literally, this regulation would seem to require nothing more than a reliable reporting system to ensure accurate reporting of test results. However, in informal communications with a knowledgeable official of the Centers for Medicare and Medicaid Services, this language was cited for the proposition that a lab that does the technical component of a procedure is responsible for the accuracy of the final result. Even if this reading is strained, as it seems to be, it is quite possible that the regulation may be seized upon by a plaintiff’s lawyer seeking to have the technical component lab held liable.

Ethical issues. Beyond the liability issue, the question also raises significant ethical issues. In 2004, the College approved a Code of Ethics for CAP members. That code, while not binding, provides a useful guide for pathologists. Two provisions are particularly applicable. First, principle two recites that “a pathologist shall place the interests of the patient foremost.” Applied here, this principle raises an obvious question: Are the pathologists at the technical component lab placing the interests of the patient foremost if they continue to perform work for a smaller lab that has “misinterpreted” some cases and that became “displeased” when concerns were expressed about its performance?

Principle four presents an even more vexing issue. That principle states that “a pathologist shall strive to report any physician...whose deficiency in character or competence jeopardizes patient care.” This basic consideration also finds expression in the Principles of Medical Ethics of the American Medical Association—which are binding on CAP members. (See AMA Statement E-9.031 [Physicians “have an ethical obligation to report impaired, incompetent, and/or unethical colleagues in accordance with the legal requirements in each state…”].)

We cannot tell from the question how serious or how frequent the misinterpretations of the flow results are. However, the pathologists at the technical component lab may want to ask themselves whether the cases that are said to have been “misinterpreted by the non-HP pathologists” reflect a “deficiency in…competence” that rises to the level of a reportable situation? Alternatively, if the smaller lab’s displeasure with the observations of the technical component lab translated into making no changes in procedure, does the failure of the smaller lab to remedy the situation constitute a “deficiency in character” that is grounds for reporting? If the technical component lab concludes it has an ethical obligation to report the situation, to what institution should the report be made—the medical staff (if there is one), the regional commissioner for the CAP Commission on Laboratory Accreditation (if the lab is CAP-accredited), or the state licensure board?

What to do? At a minimum, I would recommend that a principal of the technical component lab promptly have a direct and pointed conversation with the director of the smaller lab. In that conversation, the cases that appear to have been misinterpreted should be reviewed. Moreover, specific suggestions should be made as to steps that need to be taken to cure the problem. These steps could include hiring of an appropriately trained hematopathologist and enrollment of the lab in CAP Survey FL3-CD.

I would recommend that the conversation be followed up with a letter documenting what was said. A letter of this nature may help spur the smaller lab into action. Moreover, if the technical component lab is sued or is investigated by a regulatory authority, the letter will also be critical in documenting that that lab acted responsibly.

Unless the smaller lab immediately makes the requested changes, or takes other steps to remedy the problem, I believe that the technical component lab should seriously consider resigning the account. In making this recommendation, I recognize that resigning an account can have significant economic consequences, particularly if the account is a large one. But the technical component lab will also have to factor in the nature of the risk to patients, its potential exposure to liability, and its assessment of its ethical obligations.

If the two labs continue a relationship, consideration might be given to making the technical component lab responsible for quality assurance in the area of flow. Under this approach, the two labs could enter into a written protocol setting forth their respective duties. The document should specify the QA responsibilities of the technical component lab. It should also include quality indicators, frequency of review, and assurance that corrective action will be taken if problems are identified. Through a formal document of this nature, the sort of problems that led to the current situation might be avoided.

As for reporting, that is a bigger step—with substantial practical consequences for both labs. In this connection, I would note that the law of the state where this situation arose requires reporting to the Board of Medical Examiners where there is a “reasonable probability” that a licensed physician “has engaged in intentional or negligent conduct that…is likely to cause injury to a patient or patients.” If I were satisfied that the smaller lab was responding by taking prompt and appropriate action, I would tend not to make a report because, in my view, the making of the changes would obviate the likelihood of injury to the patient.

By contrast, if the smaller lab continued to conduct its practice as before, I believe that the technical component lab needs to make a candid assessment of the potential harm to patients from the practices of the smaller lab. If it concludes there is a significant risk of substantial patient injury that the smaller lab steadfastly refuses to address, reporting to the state board might be appropriate. In any event, the technical component lab may want to make the situation known to the accreditation organization for the smaller lab.

In the final analysis, this situation is one that calls for tact, judgment, and a careful evaluation of all the considerations. Every possible course of action carries potential legal, ethical, and practical consequences. As suggested at the beginning of this response, a knowledgeable and thoughtful attorney may be able to assist the technical component lab in working through these very difficult and nuanced issues.

Jack R. Bierig
Sidley Austin LLP
Chicago