Hospitals' Duty to Report Patient Harm

Recent reports of horrible incidents at well-known hospitals in New York City have shaken the public's faith in healthcare, and for good reason. Two of the cases involved Beth Israel Medical Center in Manhattan: the now infamous incident last year in which a doctor carved his initials in his patient's abdomen after performing a Caesarian section on her; and a tragic 1997 case involving the sudden death of a 30-year-old patient who was undergoing routine removal of benign fibroid tumors from her uterus. Another case involved Staten Island University Hospital and whether complicated brain surgery was competently performed by a neurosurgeon who previously had been dismissed from another hospital for operating on the wrong side of a patient's brain. Yet another case involved Maimonides Medical Center in Brooklyn, where a surgeon mistakenly removed a healthy kidney instead of a cancerous kidney from a patient, and the patient subsequently died.

Reporting Regs Violated

These four cases are deeply troubling not only because patients died or were seriously harmed, but also because in each case, the New York State Health Department concluded that in addition to serious lapses in medical care, the hospitals involved violated legal requirements for reporting these incidents to the Health Department. In the Beth Israel case involving the mutilation of a patient by Dr. Allan Zarkin, the Health Department found that the hospital had been less than forthcoming, citing "a failure on the part of [Beth Israel's] administrators to appropriately report the seriousness of the incident once they became aware of it."¹ Specifically, the Health Department found that in reporting the incident:

[Beth Israel] indicated only that Dr. Zarkin had been suspended because his actions toward an obstetrical patient were grossly inappropriate. No details of the carving incident were provided. Such lack of specificity in reporting was at variance with previous reports submitted [to the Department] by Beth Israel which provided explicit reasons for the suspension actions taken against other physicians.²

In the 1997 death of the young woman at Beth Israel, the hospital was fined for a variety of serious lapses in medical care, and on that occasion too, the Health Department cited Beth Israel for providing incomplete information to the Department.

In the Staten Island University Hospital case, the Health Department found "an alarmingly high number of deficiencies in the hospital's controls and procedures," to wit, 40 violations of the New York State Public Health Law (PHL) and regulations, including failure to report lapses in patient care to the Health Department. In the Maimonides Medical Center case, the Health Department again cited failure on the part of the hospital to report errors or problems to the department.

Medicine is not and never has been an exact science. Hospitals are extraordinarily complex facilities where acutely ill patients are cared for in circumstances that are difficult, at best, and at times even dangerous. Sometimes things can and do go terribly wrong. The operation of a hospital presents its administrators and staff with, among other things, daily challenges to minimize risks to patients as much as possible. It should entail a constant striving to afford patients the highest quality medical care which the hospital and its staff are capable of providing.

Past Regulations Strict

Historically, New York has had strict legal and regulatory requirements regarding the operation of hospitals and the quality of patient care. In 1985-1986, New York took additional steps by creating specific legal and regulatory requirements regarding the reporting of incidents that threaten patient safety. These were intended to address numerous instances in which the Health Department "learned of emergencies or other situations that threaten the safety and well being of the patients or the staff in hospitals, well after the emergency or incident has occurred, or through the news media."³

Accordingly, New York's Public Health Law ("PHL") was amended in 1986 to include a comprehensive set of reporting requirements for incidents affecting patient care in hospitals. PHL §2805-1(2) requires that the following Incidents must be reported to the Department of Health:

1. patients' deaths or impairments of bodily functions in circumstances other than those related to the natural course of illness, disease or proper treatment in accordance with generally accepted medical standards;
2. fires in the hospital which disrupt the provision of patient care services or cause harm to patients or staff;
3. equipment malfunction during treatment or diagnosis of a patient which did or could have adversely affected a patient or hospital personnel;
4. poisoning occurring within the hospital;
5. strikes by hospital staff;
6. disasters or other emergency situations external to the hospital environment which affect hospital operations; and
7. termination of any services vital to the continued safe operation of the hospital or to the health and safety of its patients and personnel, including but not limited to the anticipated or actual termination of telephone, electric, gas, fuel, water, heat, air conditioning, rodent or pest control, laundry services, food or contract services.

If an incident falls within those specified in paragraphs (a) through (d), the hospital must investigate, must inform the Health Department of the expected completion date of the investigation, and must provide the Health Department with a copy of the investigation report within 24 hours of completion. Health Department regulations that have been in effect since 1985 further require that all of the delineated incidents must be reported to the Department's Office of Health Systems Management (OHSM) by telephone within 24 hours of when the incident occurred or when the hospital has reasonable cause to believe that such an incident has occurred. The hospital can take no more than seven calendar days to determine whether an incident is required to be reported.⁴ The hospital then must follow up with written notification within seven days of the original notification, in a format specified by the Health Department, recording the nature, classification, and location of the incident; medical record numbers of all of the patients directly affected by the incident; the full name and title of physicians and hospital staff directly involved in the incident as well as their license, permit, certification or registration numbers; the effect of the incident on the patient; follow-up treatments and evaluations planned; the expected completion date for the hospital's investigation, and identification information required by the Health Department.⁵

Disclosure Required

The law also requires that physician problems be promptly disclosed to the department. PHL §2803-e(l)(a) requires that hospitals must report within 30 days any of the following:

• The suspension, restriction, termination or curtailment of the training, employment, association or professional privileges of a doctor or resident for "reasons related in any way to alleged mental or physical impairment, incompetence, malpractice or misconduct, or impairment of patient safety or welfare."
• The voluntary or involuntary resignation or withdrawal of association or of privileges with such facility to avoid the imposition of disciplinary measures.
  
  
• The receipt of information which indicates that a professional licensee has been convicted of a crime.
• The denial of staff privileges to a physician if the reasons stated for such denial are related to alleged mental or physical impairment, incompetence, malpractice, misconduct or impairment of patient safety or welfare.

PHL §2803-e(2) requires that such reports be in writing, and include "a description of the action taken by the hospital including the reason for the action and the date thereof, or the nature of the action or conduct which led to the resignation or withdrawal, and the date thereof . . . ."

The law contains specific confidentiality protections covering these reports and the information contained therein, as well as immunity from civil or criminal liability for reports made in good faith. PHL §2803-e(3). Hospitals also have 60 days within which to report "any information which reasonably appears to show that a physician is guilty of professional misconduct" as defined in New York Education Law §6530-31.

If a hospital attempts to circumvent these reporting requirements by obfuscation, or using euphemisms, or submitting incomplete information, it not only flouts the law but does a serious disservice to the patients and public that it is supposed to serve. As a result of these recent incidents, the Legislature is considering amending the PHL's reporting mandates to require hospitals to do what they should be doing already: filing clear and complete reports explicitly describing the incident or clearly explaining the reasons for disciplining a physician. The Patient Health Information and Quality Improvement Act of 2000⁶ introduced by Senate Health Committee Chairman Kemp Hannon and others, would tighten these reporting requirements by reducing from 60 days to 30 days the time within which hospitals have to conduct their investigations of incidents or to report physician problems. The proposed legislation would also amend PHL §2803-e to require hospitals to furnish in writing: A description of the action taken by the hospital, including the reason for the action and the date thereof, or the nature of the action or conduct which led to the resignation or withdrawal, and the date thereof stated with sufficient specificity to allow a reasonable person to understand which of the reasons enumerated in subdivision one of this section led to the action of the hospital or the resignation or withdrawal of the individual, and, if the reason was an act or omission of the individual, the particular act or omission."

Investigation in 30 Days

In addition, the proposed legislation would amend PHL §2805-1 to require that hospitals conduct investigations of incidents within 30 days, and would include among the incidents that must be reported by hospitals: "The receipt of any information which reasonably appears to show that an individual licensed pursuant to the provisions of Title 8 of the Education Law or a medical resident of a hospital is subject to mental or physical impairment, or is guilty of incompetence, malpractice or misconduct or impairment of patient safety or welfare, or has been convicted of a crime."

In the meantime, New York State's Commissioner of Health, Dr. Antonia C. Novello, has taken a hard line on hospitals' failures to protect patients and to abide by reporting requirements. In announcing fines and corrective action against Staten Island University Hospital, Dr. Novello declared: "This department will continue to ensure that all hospitals across the state take whatever steps necessary to make patient safety paramount. If hospitals are not operating at standards acceptable to the State Health Department to ensure patient care, this department will act swiftly and decisively to hold them accountable."⁷

The Highest Priority

Dr. Novello continued: "Protecting patients and ensuring that they are receiving quality care is of the highest priority to this department. We will continue to work with hospitals that want to improve their systems and procedures to meet our standards of care. And, we will continue to cite those hospitals that are derelict in their duties in a public way and with expediency."⁸

In the Beth Israel, Staten Island, and Maimonides cases, the Health Department levied the maximum fine available under the law, $2,000 per violation,⁹ for each violation cited including the inadequate reporting to the Health Department. Critics say that is not a sufficient remedy or deterrent. The Legislature last raised the maximum fine from $1,000 to $2,000 in 1990. Perhaps the time has come for the Legislature to revisit this as well, and to consider equipping the Health Department with more appropriate sanctions when patient safety has been jeopardized and reporting requirements flouted.

Francis J. Serbaroli is a partner in Cadwalader, Wickersham & Taft. He is the author of The Corporate Practice of Medicine Prohibition in the Modern Era of Health Care, published by BNA.

1. New York State Health Department News, Health Department fines Beth Israel for Deficiencies; Actions Come as a Result of Investigation into Dr. Zarkin case," Health Department Website, www.health.state.ny.us/nysdoh/ commish/2000/bethisrael.htm, Feb 2, 2000.
2. Id.
3. New York State Register, Vol. VII, Issue 39, p.17 (Sept. 25, 1985).
4. 10 NYCRR §405.8(a).
5. Senate Bill 6741.
6. New York State Health Department News "Health Department Fines Staten Island Hospital for Deficiencies; $80,000 in Fines Must be Paid Immediately and in Full; Corrective Actions Mandated," Health Department Website, www.health.state.ny.us/nysdoh/commish/2000/sihosp2.htm, Feb. 29, 2000.
7. Id.
8. PHL §12(1).

This article is reprinted with permission from the March 30th issue of the New York Law Journal © 2000 NLP IP Company.