When we first read the article on Clinical Guidelines below, we were excited to share it with you. This information is invaluable in reducing your risk, especially as you set up your practices to fit new government requirements.
We are delighted to have Susan O. Martin, RN, JD, Executive Vice President, Litigation Management / Loss Control of Best Practices Insurance Services, LLC, as our special guest blogger. In the following article, she discusses the importance of Clinical Guidelines and Performance Standards and how they are Improving Quality to Decrease Risks.
There is no doubt that the ultimate goal of all health care practitioners is to improve patient outcomes. Attorneys want better outcomes as well, because happy, satisfied patients correlate to fewer lawsuits filed against health care providers. While performance standards, professional clinical guidelines or protocols of care are often employed in an attempt to improve outcomes, as an attorney, it is problematic to review or give advice regarding them because plaintiff attorneys will try to use these documents as “standards of care,” even if that is clearly not the intent. For example, if a protocol states that a patient is to have antibiotics on board within a specific time of the diagnosis of pneumonia, and the antibiotic is given twenty minutes after the time period required, is that considered a violation of the standard of care?
The Rise of Clinical Guidelines & Performance Standards
Emergency physicians and emergency medicine groups execute agreements with their hospital partners which place clinical guidelines and performance standards and core measures directly on the physicians in the practice. Most medical specialty organizations and institutions require some form of clinical performance measurement as well.
For example, the American College of Cardiology and the American Heart Association have recommended core measures for treating patients with ST segment MI and non ST segment MI. Those cases used to represent the majority of cases filed against emergency room physicians, but in the past five years, the “missed MI” cases out of the emergency department are very few. Now, with the institution of the “code STEMI” in the pre-hospital care environment, and the hospital cath labs responding immediately, patients are having better outcomes and heart muscle salvage.
Many of these core measurements are used by the Centers for Medicare & Medicaid Services (CMS) for post review of the quality of care delivered to Medicare patients. While many practitioners would argue that CMS is merely looking for an avenue to deny payment to those facilities and physicians who do not follow the criteria, CMS would argue it is only seeking better outcomes for its beneficiaries, including decreased hospital admissions. Unfortunately, many times these performance criteria are promulgated by committees or hospitals as “standards of care,” which further expose medical staff members.
Clinical Guidelines & Performance Standards vs. Standards of Care
The term “standard of care” is a legal term used in courts of law to determine a practitioner’s duty to a patient. Standards of care are determined by jury, judge and/or expert testimony. In contrast, clinical guidelines – performance standards are recommendations by hospitals, medical staff committees and professional review organizations to provide a “road map” for practitioners to consider. As recommendations that change over time, these guidelines should not set policy. They should never be considered as hard evidence in a medical malpractice lawsuit. It is recommended that any clinical guidelines or protocols set up for mid-level practitioners, physicians, or other health care providers have language that allows the practitioner the flexibility to use his or her own independent medical judgment.
Tips for Writing Clinical Guidelines & Performance Standards
In writing such guidelines, we suggest the following:
• Clinical guidelines – performance standards should have the following language at the beginning of the page:
“These guidelines are tools and considerations for the practitioner’s use and are not intended to suggest or dictate medical standards of care. Each patient has individualized needs and each practitioner must use his or her own professional independent judgment in medical decision making for each patient’s treatment plan of care. “
With this language at the beginning of each clinical recommendation, you can respond accordingly. If asked in deposition testimony, you can state that you know of the guidelines, but you determined that your patient, Jane Doe, needed different treatment modalities, and you were acting in the best interest of the patient at the time of care.
• Use caution in using words such as “practitioners shall always”or “practitioner shall ensure that.”
Again, the wording must give flexibility for the practitioner and should not denote absolute terms.
• Nursing policies can be somewhat more problematic, yet required by the Joint Commission on Accreditation of Health care Organizations (JCAHO) and nursing boards. Nurses are accustomed to policies and procedures, which they strictly construe. For example, instead of a policy that states, “Vital signs shall be repeated every two (2) hours,” a departure from which would be considered a violation of hospital policy, if possible, allow patient acuity to better define the guidelines. It would be better to state, “Vital signs shall be repeated according to the acuity of the patient or as ordered by the physician.” In this manner, nurses are not charged with taking repeat vital signs on non-acute patients or patients who do not require it.
Get Involved – Develop Clinical Guidelines & Performance Standards
Whatever term is used core measurements, performance standards or clinical guidelines – these policies are here to stay. It is in the practitioner’s best interest to assist in the development of these measurements in their hospitals and/or their specialty organizations to draft reasonable and medically sound criteria that gives flexibility and allows practitioners to continue to determine individual patient needs.
About Susan O. Martin, RN, JD
Susan has a unique background that compliments the integrity of AMS Best Practices. Prior to joining Best Practices, she was Chief Legal Counsel for a physician management group consisting of primary care, multi-specialists and ED physicians. Prior to her role as Chief Legal Counsel, Susan managed the litigation and risk management for a large, national physician practice management company (EmCare). She has also been in private practice defending physicians in lawsuits, as well as handling regulatory matters and insurance coverage issues.
About Best Practices Insurance Services, LLC
Best Practices Insurance Services, LLC (BPIS) is the exclusive agent for Applied Medico-legal Solutions Risk Retention Group (AMS RRG) providing underwriting, brokering, clinical risk management, claims management oversight and distribution services.
For questions regarding Clinical Guidelines & Performance Standards: Improving Quality to Decrease Risks, please contact Steve Shapiro, MD, Chief Medical Officer, at (800) 367-1 337 or Susan Martin, Esq. at (866) 520-6896.
If you’ve liked what you have read here, please share the information with your colleagues. Our agency’s goal is to provide you with information that will enable you to reduce risk and malpractice claims, so that you can enjoy a successful practice. We welcome any thoughts or suggestions on how we can help you achieve these goals.
If you have questions about reducing insurance premiums, risk reduction and improving overall coverage, feel free to contact me, Michelle Perron, personally at (603) 926-1318.