DAL 16-04: Immediate Jeopardy Rules and Regulation Letter

March 18, 2016
DHDTC DAL 16-04

Dear Chief Executive Officer:

The purpose of this letter is to share information related to determinations made by the Department of Health (the Department) that provider noncompliance with regulatory requirements has placed or could place patients in Immediate Jeopardy (IJ) of serious injury, harm, or impairment. The Department's goal in sharing this information is to assist hospitals in understanding the basis of an IJ determination and in remaining in compliance with State and Federal requirements.

We strongly recommend hospital personnel review current operations and compare them with the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (CoP) (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf), the New York Codes of Rules and Regulations, Title 10, Section 405 (https://regs.health.ny.gov/content/part-405-hospitals-minimum-standards) and applicable standards of care to assure ongoing compliance.

When a survey team is conducting an on-site survey, whether a routine survey or a complaint investigation, the team members will gather and validate information. If the team identifies any information that suggests the provider is noncompliant with one or more standards of a Federal CoP and that a current situation is likely to cause serious injury, harm, or impairment to a patient (42 CFR Part 489.3), the team, in consultation with program leadership, will evaluate whether the situation meets the definition of IJ.

The definition of IJ includes a consideration of whether actual or potential harm has occurred, or could occur in the very near future unless intervention is undertaken, and whether hospital personnel are aware of and compliant with institutional policies and procedures. It is important to note that only one individual patient needs to be at risk to warrant identification of an IJ situation. Once notified of the IJ situation the hospital is required to take immediate corrective action to prevent potential or actual patient harm.

Certification of hospital compliance with the CoPs is accomplished through observations, interviews and document/record review. The survey process focuses on the provider's performance of patient-focused and organizational functions and processes. Providers should review the CoPs, compare them to their institutional practices and policies, and make revisions as required.

In the two-year period, from October 10, 2013 to October 1, 2015, the Department has identified forty-one (41) IJ situations. In thirty (30) of these IJ situations, the CoPs of Patient's Rights or Surgical Services were found to be out of compliance. This letter discusses each of these areas below.

Condition of Participation: Patients' Rights

The intent of Patients' Rights is to protect and promote each patients' rights, which includes a safe patient environment that is free from abuse and neglect. Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. Neglect, for the purposes of the requirement, is a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental health. The most frequent determinations of IJ under the CoP of Patients' Rights fell into three categories: Abuse, Infant Abduction and Restraints.

Of the IJ situations where the CoP of Patients' Rights was determined to be out of compliance, the failure to protect patients from abuse was cited ten (10) times. Issues concerning Infant Abduction alarm systems were cited seven (7) times and issues regarding the use of restraints by security guards or other staff were cited four (4) times.

Abuse

Hospitals must have mechanisms in place to ensure patients are free from all forms of abuse. Hospitals must also have policies and procedures that dictate steps to investigate allegations of potential abuse, whether the accused is an employee, a visitor, or another patient. The Department has identified multiple systems issues related to preventing and responding to alleged or confirmed sexual, verbal and physical abuse committed by staff, visitors or by other patients. The following recommendations are based on actual findings that resulted in IJ determinations. The Department recommends that a hospital:

  • Develop and implement policies and procedures to prevent, report, respond to, and investigate alleged abuse;
  • Assure that all staff, including employees and non-employee contract staff, are trained in abuse policies and procedures;
  • Ensure that staff report alleged abuse to nursing and/or administrative leadership per hospital policy;
  • Provide for the immediate protection of patient(s);
  • Assess the potential victim of alleged abuse;
  • Perform a comprehensive investigation of an allegation of abuse consistent with the CMS State Operations Manual Section 482.13 (c)(3); and
  • Notify involved persons, such as the patient's physician and social worker, of alleged abuse in accordance with hospital policy.

Infant Abduction

Providers are required to have policies, procedures, and systems in place to ensure the safety of infant and pediatric patients. Many hospitals employ automated alert systems, known as Infant Abduction Systems, as part of their infant and pediatric patient safety program. The Department has noted several issues related to the use of Infant Abduction Systems. If a provider chooses to use an Infant Abduction System, the provider should ensure that the system is functioning according to manufacturer's requirements and that it is part of a broader infant and pediatric patient safety protection program. The following recommendations are based on actual findings that resulted in IJ determinations. The Department recommends that, if employing an Infant Abduction System, a hospital must:

  • Develop and implement policies and procedures for the use of the infant abduction system, as part of a comprehensive infant and pediatric patient safety program;
  • Assure that all appropriate staff, including employees and non-employee contract staff, are trained on the policies and procedures;
  • Train appropriate staff on the infant abduction system;
  • Ensure the electronic infant protection system has a functioning audible alarm;
  • Ensure all exits on the unit lock when alarms are activated;
  • Provide operational security cameras that cover areas that cannot be easily visualized by hospital staff;
  • Ensure staff are monitoring the security cameras;
  • Periodically test the system to ensure ongoing functionality; and
  • Review and immediately correct previously identified failures of the system.

Even if the hospital has an automated abduction system, there should be a procedure or mechanism to identify visitors and staff to the infant and pediatric units in the event that the system fails or is disabled, and to report any unauthorized individuals.

Each situation is evaluated on a case-by-case basis. The failure to have one of these requirements in place may not necessarily result in a citation if the hospital has another mechanism in place to meet the intent and the system as a whole provides adequate protection. For example, if the hospital has an exit that is not covered by a security camera, they could compensate for this by having security personnel cover that exit.

Restraints

Hospitals should have mechanisms in place to ensure that all staff that the hospital has authorized to apply restraints, including security personnel, are trained in the use of all restraints, cardio-pulmonary resuscitation and first aid, for the safety of all patients. The Department has identified concerns related to the use of restraints by clinical staff and security personnel. The following recommendations are based on actual findings that resulted in IJ determinations. The Department recommends that a hospital:

  • Develop policies and procedures that clearly identify staff who are authorized to use restraints, including physical and chemical restraints, and describe their appropriate use, as well as the use of de-escalation techniques and alternatives to restraints, timely release restraints and timely reassessment;
  • Ensure that staff who are authorized to apply restraints, including security personnel, are trained in cardio-pulmonary resuscitation first aid, and the appropriate use of restraints (including physical holds), and that they are trained and understand when it is appropriate to apply a restraint and what restraint is appropriate to use as outlined in the hospital policies and procedures; and
  • Ensure that security staff are specifically authorized and trained to use restraints and are not utilizing law enforcement devices such as handcuffs, chains, manacles, leg irons, etc. to restrain patients.

Condition of Participation: Surgical Services

If a hospital chooses to provide surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. Acceptable standards of practice include maintaining compliance with applicable Federal and State laws, regulations and guidelines governing surgical services or surgical service locations. In addition, compliance with standards and recommendations promoted by, or established by, nationally recognized professional organizations (e.g., the American Medical Association, American College of Surgeons, Association of Operating Room Nurses, Association for Professionals in Infection Control and Epidemiology, etc.) comprise acceptable standards of clinical practice. The following recommendations are based on actual findings that resulted in IJ determinations. The Department recommends that a hospital:

  • Develop and implement policies and procedures related to surgical attire;
  • Assure that all appropriate staff are trained in the policies and procedures;
  • Periodically assess the use of appropriate surgical attire and compliance with the policies and procedures; and
  • Ensure staff are wearing appropriate and approved surgical attire in the operating room (i.e., masks, face shields).

The Department is committed to working with all providers to improve service delivery and ensure patient safety. We hope that this information highlighting specific findings will prompt you to examine compliance with these areas in your hospital. If you have any questions, please contact the Division of Hospitals and Diagnostic & Treatment Centers at 518-402-1004.

Sincerely,
Ruth Leslie
Director
Division of Hospitals and Diagnostic & Treatment Centers