In matters of hospital and healthcare facility negligence, an experienced nursing administration expert witness can provide valuable assistance in identifying and evaluating whether existing hospital and healthcare facility regulatory and accreditation standards apply to case issues.

1. What regulatory and accreditation standards apply to the hospital and health care facility setting?

The following lists the most common accreditation and regulatory organizations in patient health and safety in U.S. hospitals and care facilities.

US regulatory and accrediting organizations are divided into four distinct categories: (1) Federal Regulations, (2) State Regulations, (3) Accrediting Organizations, and (4) Organizations that set specialty-specific standards of care guidelines.

1. Federal Regulations:
   A.  Centers for Medicare and Medicaid Services (CMS): cms.gov
   B.  US Food and Drug Administration (FDA): fda.gov
   C.  Occupational Safety and Health Administration (OSHA): osha.gov
   D.  Centers for Disease Control (CDC):  cdc.gov
   E.  National Institute of Health (NIH): http://www.nih.gov
2. State Regulations:
   A.  State Administrative Codes: http://www.administrativerules.org
   B.  Individual State Board of Nursing: https://www.ncsbn.org/index.htm
3. Accreditation Standards:
   A.  The Joint Commission (TJC): jointcommission.org
   B.  DNV GL Healthcare: http://dnvglhealthcare.com
   C.  Accreditation Commission for Healthcare Inc. http://www.achc.org 
   D.  Commission on Accreditation of Rehabilitation Facilities (CARF): carf.org
4. Organizations with established Standards of Care Guidelines:
   A.  Substance Abuse Mental Health Services Administration (SAMHSA): http://www.samhsa.gov
   B.  Agency of Healthcare Research and Quality (AHRQ): http://www.ahrq.gov
   C. National Quality Forum: NQR:Home
   D. Institute for Safe Medication practices: ISMP
   E. Association for Professionals in Infection Control and Epidemiology: Home – APIC
   F. The Association for the Advancement of Medical Instrumentation: AAMI Main Page | AAMI

   2.  The Use Of Accreditation And Regulatory Standards To Identify Supervisory Responsibility For Claims Of Breach in the Standard of Care

Regulatory and accreditation standards are valuable methods for a nursing administration expert witness to demonstrate when an individual or a healthcare facility is non-compliant or negligent. These standards can identify organizational system failures beyond the specific department where the event occurred. In practice, when safety measures are violated, leading to serious harm and damage to a patient, organizational system failure within the entire chain of command may have directly or indirectly contributed to the patient’s injuries.

Accreditation standards that address leadership responsibility can be utilized to identify additional potential defendants in a negligence or medical malpractice case, such as the nursing management that leads and directs the nursing staff at issue.

A.  PLAINTIFF’S CASE: Demonstrating Organizational System Failure From First Point Of Contact To Senior Leadership.

Patient Scenario:  A patient died in an acute care facility because of a significant medication error.  Before the patient’s death, the patient showed signs of worsening mental status and declining vital signs.  Multiple alerts were communicated from the family to the nursing staff. The nursing staff on this medical unit could not transfer the patient to a higher level of care due to a lack of intensive care bed availability and short staffing in the ICU.  The nursing supervisor notified the administrator on-call to address the issue of providing ICU care for a patient in a medical unit. Still, no guidance was provided by the administrator on-call.  The chief nurse executive was not notified of the staffing and bed availability issue until the next day.

Plaintiff’s nursing administration expert witness utilized her knowledge of accreditation standards to identify management and senior leadership conduct that fell below standards of care.  Based on the accreditation standards, the nursing administration expert witness identified neglectful conduct by three senior hospital employees: the Chief Operations Officer, the administrator on-call the night of the patient’s death, the Nurse Supervisor, and the Medical Unit Charge Nurse. The Chief Nurse Executive (CNE) was also held responsible for the conduct of the nurses providing care for this patient, since the CNE is ultimately responsible for the overall functions of the nursing department and all nursing care.   As defined in the CMS Conditions of Participation A-0386 describing the responsibility of the Chief Nurse:  “He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.”

In this case, the applicable standards of care originated from the Centers for Medicare and Medicaid Services Conditions of Participation (CMS) 482.23 Nursing Services.   The CNE,the medical unit charge nurse, and the nurse supervisor failed to ensure:

1.  The nursing staff in the medical unit failed to follow the hospital policy on modified early warning systems.
2.  Appropriate staffing was implemented to care for a patient with a significant change in status in the Medical Unit while   awaiting an ICU bed.
3.  Adequate staff numbers were accounted for in the ICU,
4.  A contingency plan for staffing a critical unit and bed management plans.
5.  Nurse executive oversight was provided 24 hours a day, 7 days a week
6.  A functioning chain of command was in place when the patient suffered a significant change in condition.

The nursing supervisor and the COO/administrator-on-call failed to notify the CNE and initiate the patient flow/surge plan to ensure the proper placement of a critically ill patient.

3. Use of Accreditation Standards To Rebut Claims Of Breach In Medical Malpractice Actions.

A nursing administration expert witness can effectively use regulatory and accreditation standards that reflect the applicable standard of care to address and refute claims of breach against hospitals and associated facilities. Medical facilities subject to regulatory and accreditation standards, such as the Conditions of Participation or The Joint Commission standards, may point to compliance with these standards in defense of malpractice claims against them.

B.  DEFENSE CASE: Using regulatory and accreditation standards to demonstrate the rehabilitation facility’s compliance with the applicable standard of care

Facts: A newly admitted patient to a rehabilitation facility was being treated for a community-acquired pressure ulcer.  Over time, this patient developed an infection in the pressure ulcers and was admitted to an acute care hospital for treatment, subsequently deceased due to sepsis.

The defense nursing administration expert witness’s knowledge of CMS’s conditions of participation, state law and accreditation standards enabled her to identify the specific standards demonstrating how the rehabilitation facility and its staff engaged in proper conduct pursuant to standards of care.

The rehabilitation and hospital facility’s compliance with regulatory and accreditation standards of care at the time the patient was under the facility’s care allowed the defense counsel to effectively demonstrate that:

1.  Infection control measures, such as hand hygiene protocols and isolation procedures, complied with applicable   standards of care.
2.  An infection control plan was operating pursuant to standards of care, including protocols for identifying risks and   acquiring and transmitting infections.
3.  A reasonable plan was in place to reduce the risk of infections from medical devices and supplies.
4.  An evaluation risk assessment was also in place to show the facility has prevented infections from pressure ulcers over   time.

Relying on the nursing administration expert witness’ knowledge of applicable existing regulatory and accreditation standards,  the defense was also able to effectively demonstrate the following according to regulatory and accreditation standards of care:

1. Standards of care were met in staffing requirements. Despite the patients’ harm, the rehab facility hired a sufficient number of well-trained staff.
2. The patient’s nutritional needs were met according to standards of care because the organization could illustrate consistent assessment and reassessment of dietary needs according to the Centers for Medicare and Medicaid.
3. Lastly, adherence to skin care guidelines was met. In this case, because the rehab facility Director of Nursing and staff nurses met conditions of participation, including the applicable state code and published skin care guidelines, the defense demonstrated objective evidence that standards of care were met effectively.

4. Conclusion

Federal and state regulations and accreditation standards are drafted and defined by accepted standards of care and practice.

These sources may be relevant in negligence and medical malpractice cases for a nursing administration expert witness to demonstrate evidence of compliance with the current standard of care by relevant hospital employees, including those in management and senior leadership positions.   As advised in the earlier scenario, these regulations and standards can be a point of comparison to fairly evaluate the work performed at the bedside by nurses, physicians, therapists, and all applicable specialists.

A nursing administration expert witness can assist in determining the applicable regulatory and accreditation standards and whether the care team’s conduct met those regulations/standards.

Gayle C. Nash is the Chief Executive Officer of Nash Healthcare Consulting (NHC).  NHC provides accreditation assist visits to hospitals, clinics, surgery centers, and behavioral health hospitals. She is a previous nurse surveyor for the Joint Commission and a former hospital chief nursing officer, and she is available for consultation as a nursing administration expert witness.  Ms. Nash can be reached at gnash@nashhc.com
c: 915-241-7830
www.nashhealthcareconsulting.com