By Armand Leone, Jr.
Over 20,000 Standards
Medical Practice Guidelines Are Useful Tool in Litigation
Healthcare practice guidelines, issued by federal government agencies and physician specialty organizations in an effort to formalize the current medical practice standards, appear to be the wave of the future. With each new guideline, the practice of medicine becomes less of an art and more of a set of algorithms-algorithms that are increasingly being used to determine liability in medical malpractice suits. Lawyers engaged in the prosecution and defense of medical malpractice claims need to be aware of and use practice guidelines when representing their clients.
As the number of healthcare guidelines increases, this task becomes more formidable. There are more than 20,000 healthcare standards, clinical practice guidelines, laws and regulations published by more than 500 medical organizations and state and federal agencies, according to the Healthcare Standards Directory 1993 (see story, Page 2.).
In 1989, the federal government established the Agency for Healthcare Policy and Research, which was directed to convene non-governmental panels of experts to develop clinically relevant practice standards and assessments ("guidelines") for healthcare procedures. Through its Office of Health Technology Assessment, this agency has published at least 118 guidelines relating to healthcare. The guidelines cover not only highly esoteric subjects, but such commonplace procedures as: cardiac catheterization in a free-standing setting, debridement of mycotic toenails, diagnosis and treatment of impotence, hydrotherapy (whirlpool) baths for treatment of decubitus ulcers, melodic intonation therapy, and patient selection criteria for percutaneous transluminal coronary angioplasty. While the agency does not technically endorse its guidelines, it publishes them under the auspices of the Department of Health and Human Services, whose logo is included on the document. Ultimately, physicians, patients and courts will view these guidelines as endorsed by the U.S. government.
Medical specialty groups, such as the American College of Cardiology, the American College of Surgeons and the American College of Radiology, have published practice guidelines for member physicians. Recommendations of specialty accreditation organizations carry great weight within each medical specialty and ultimately bear on the standard of care rendered by their members. These organizations issue guidelines ranging from standards to committee opinions and consensus reports. The weight accorded to each type of guideline varies, with standards being the most persuasive evidence of the applicable standard of care.
For example, the American College of Radiology (ACR), in conjunction with the American Cancer Society and the American College of Surgeons, has promulgated standards for the treatment of breast cancer. These standards recommend conservative lumpectomy with radiation therapy and represent a significant change from current practice, under which most women with breast cancer are treated with mastectomy.
The result of these new ACR standards is that, with few exceptions, most women with modest- or small- size breast tumors are good candidates for breast conservation. The American Cancer Society's past-president, Dr. Robert V.P. Hutter, believes that these standards represent a formalization of current practice among the medical specialties involved in breast cancer. This formalization of current practice will ultimately determine the standard of care for treatment of women with breast cancer. The ACR has also published standards for other radiological procedures, such as for the performance of screening mammography, magnetic resonance imaging and antepartum obstetrical ultrasound.
In an attempt to disclaim the impact of its standards, the ACR provides the following notice to its member radiologists:
"The standards of the American College of Radiology are not rules but attempt to define principles of practice which should generally produce high quality radiological care. The radiologist may exceed an existing standard as determined by the individual patient and available resources. The standards should not be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any procedure or course of conduct must be made by the radiologist in light of all circumstances presented by the individual situation. Adherence to ACR standards will not assure successful outcome in every situation. It is prudent to document the rationale for any deviation from these suggested standards in the radiologist's policies and procedures manual or, if not addressed there, in the patient's medical record."
However, despite attempts to limit the applications of published standards, the ACR and other medical specialty groups are creating a nationalized standard of care through the publication of practice guidelines.
Payment by Guidelines
Practice guidelines have already been used by third-party payers as a measure of the appropriateness of care for reimbursement purposes. In 1984, the American College of Cardiology (ACC) adopted parameters for the implantation of pacemakers. The Health Care Financing Administration established a policy that Medicare would only reimburse physicians for pacemaker implants that satisfied the ACC guidelines. By 1988, the HCFA policy resulted in a decrease in the frequency of pacemaker implantation from 202 implants per 1,000 Medicare patients to 176 implants per 1,000. Blue Cross now uses the American College of Physicians' guidelines for hospital admission tests to determine the tests it will pay for.
Just as compliance with medical guidelines is used to determine the appropriateness of care for reimbursement purposes, such compliance is also being used to establish the presence or absence of medical malpractice liability at trial. By establishing practice guidelines, the traditional "community standard of care" is being replaced by a national standard. Plaintiffs attempt to argue that a failure to follow a guideline is per se negligence, while defendants argue that adherence to them is an absolute defense against liability. A few reported cases even discuss healthcare guidelines in determining the applicable standard of care 'Plaintiffs' attorneys who are knowledgeable about the relevant guidelines are generally able to settle a case based on the physician's noncompliance. In situations where the applicable guidelines have been followed, plaintiffs' counsel can avoid the expense of commencing an action that has little chance of recovery. The U.S. Court of Appeals for the Third Circuit is one of the few courts that has addressed the application of healthcare guidelines in deter-mining liability for medical negligence. In that case, Titchnell v. U.S., 681 F.2d 165 (1982), an elderly plain-tiff suffered a stroke after receiving a vaccine under the National Swine Flu Immunization Program of 1976.At issue was whether the immunization center was negligent for failing to take a medical history before administering the vaccine. The Allegheny County Health Department guidelines applicable to the immunization program were received into evidence by the trial judge, and the government appealed a finding in favor of the plaintiff. Those guidelines required the clinic to "[a]scertain that the vaccinee (or his guardian) understands the Information/Registration Form by asking the following questions: a) Do you understand the form which you have read and signed? b) Do you have a chronic heart, lung, liver or kidney disease or diabetes? c) Are you less than 18 years of age? Do you have any other medical questions? Are you allergic to eggs? Do you have a fever? Have you received measles vaccination within the past 14 days or a vaccination containing diphtheria, pertussis or tetanus antigen within the last 24 hours." The only question asked of the plaintiff was whether he was allergic to eggs.
There was no direct expert testimony or other direct evidence at trial that standard medical practice required the taking of a medical history. However, the guidelines and testimony of clinic personnel established that oral questions that should have been asked were not. The clinic nurse, the district health officer and an expert on causation all based their opinions regarding the clinic's deviation from the acceptable standard of care on the failure to follow the guidelines.
The court held that a fact finder could predicate a finding of negligence caused by a deviation from standard accepted medical practice. The failure to ask the additional questions was a failure to use the proper precautionary measures. The Third Circuit's rationale for using the guidelines as evidence of the applicable standard of care in Titchnell is sound. It is both proper and desirable that health care facilities promulgate guidelines and define responsibilities for their own personnel. Such guidelines serve to orient and instruct personnel as to their responsibilities and, further, help assure consistency in the quality of care rendered.
Just as the Allegheny County guidelines provided evidence of the standard of practice within all the clinics of that county, medical specialty guidelines provide evidence of the standard of practice expected of all physicians certified in a given medical specialty.
Where a given guideline is not promulgated by a recognized medical specialty organization - such as a private insurer's risk management guideline - that guideline is not relevant evidence on the issue of the applicable standard of care, because it does not reflect a generally recognized standard of care within the profession. Quigley v. Jobe, 1992 Colo. App. Lexis 420 at 3 (Nov. 19,1992).
The use of healthcare guidelines to assess negligence has also been discussed in the context of nursing malpractice. Armed with the proper standards, guidelines and directives, plaintiffs' attorneys can articulate a specific standard of care that a "reasonably prudent nurse" must follow and can clearly demonstrate how a nurse in a specific situation failed to meet that standard.
Using healthcare guidelines is directly analogous to the well-established principle that the violation of a statute or ordinance is evidence of negligence. This analysis applies when the provisions of a statute or ordinance are germane to the type of hazard involved in the defendant's asserted duty. Where the provisions of a healthcare guideline are germane to the type of hazard involved in the defendant physician's asserted duty, a failure to follow that guideline should also permit an inference of negligence. The standardization of medical specialties began as an effort to ensure that the same quality of care would be rendered regardless of the location of the physician's practice. Practice guidelines were issued by various governmental agencies and medical specialty organizations. It was inevitable that these very same guidelines would be used by third-party payors and courts as evidence of the appropriateness of the care rendered patients.
Unfortunately, the complexity and variety of medical practice guidelines today make it necessary for physicians and healthcare/medical malpractice lawyers to continuously monitor the guidelines relevant to their practice. It behooves lawyers to be familiar with the healthcare guidelines in order to properly represent their clients. Familiarity with the relevant guidelines allows more effective pretrial discovery and maximizes an attorney's chances of a successful settlement or outcome at trial.
1) Bradford v. McGee, 534 So.2d 1076 (Ala. 1988) (expert opinion based on recommendations of the American College of Obstetrics and Gynecology): James v. Woolley. 523 So.2d 110 (Ala. 1988) (expert quoted a technical bulletin of the American College of Obstetrics and Gynecology); Pollani v. Goldsmith. 572 P.2d 11201 (Aril. 1977) (expert accepted guide-lines of the Committee on Trauma of the American College of Surgeons regarding prophylaxis against tetanus and wound management).
2) Donna L Guarriello, Nursing Malpractice Litigation: Toward Better Patient Care. 18 (10) Trial, 78, 78-79 (1982). See also Ramsey v. Physicians' Memorial Hospital Inc.. 373 A2d 26 (Md. Ct. Spec. App. 1977) (failure of nurse to follow emergency room procedure).
3) Braitman v. Overtook Terrace Corp.. 68 NJ. 368,385386 (1975); Shatz c. TEC Technical Adhesives. 174 NJ. Super 135, 144 (Ap. Div. 1980) (violation of a statute); Rodgers u. Reid Oldsmobile Inc. 58 NJ. Super 375,385 (App. Div. 1955) (violation of an ordinance); Sanertee v. Orange Glenn School District, 177 P.2d 279 (Cal. 1947); Landry i, Hubert, 141 A.2d (Vt. 1928); Martin v. Herzog, 126 N.E. 814 (N.V. 1920); W.L Prosser, The Law of Torts. Sec. 36 at 20002 (4th ed. 1971).
The article is reprinted with permission from Medical Malpractice - Law & Strategy, Vol X, No. 6, (April 1993).