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

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

The following is a listing of the most common accreditation and regulatory organizations that regulate and govern healthcare practitioners in the areas of 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) those organizations that set field specific standard of care guidelines.

  • Federal Regulations:
    A.  Centers for Medicare and Medicaid Services (CMS):
    B.  US Food and Drug Administration (FDA):
    C.  Occupational Safety and Health Administration (OSHA):
    D.  Centers for Disease Control (CDC):
    E.  National Institute of Health (NIH):
  1. Use Of Accreditation And Regulatory Standards To Identify Management And Senior Level Health Care Facility Employees Who Bear Supervisory Responsibility For Claims Of Breach.

Regulatory and accreditation standards provide evidence of the applicable standards of care and can be used in demonstrating breach. A nursing expert witness experienced in health facility regulatory compliance can be utilized to identify those situations where these standards may, in fact, identify organizational system failures well beyond the specific department where the event occurred. In practice, when safety measures are breached leading to serious harm and damages to a patient, organizational system failure within the entire nursing management chain of command may have contributed to the patient’s injuries.

Accreditation standards that address chain of command responsibility may uncover additional potential defendants in a medical malpractice case, such as the nursing management that leads and directs the nursing staff at issue.

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

Facts:   A patient died in an acute care facility as a result of a medication error.  Prior to the patient’s death, the patient showed signs of worsening mental status, declining vital signs and multiple alerts from family to nursing staff that the patient’s health was deteriorating.  Staff was unable to transfer the patient to a higher level of care due to a lack of intensive care availability and short staffing in the ICU.

The nursing administration expert witness reviewing the case utilized her knowledge of accreditation standards and quality assurance to identify management and senior leadership conduct that fell below standards of care.  Based on the accreditation standards, the nursing administrator expert witness identified negligent conduct by four senior hospital employees:  the Chief Nursing Officer, the Nurse Supervisor, the Human Resources Director, and the Pharmacy Director.

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 Chief Nursing Officer and the Nurse Supervisor failed to ensure:

  • That nursing competency and education was provided,
  • The nurses followed rapid patient rescue systems,
  • That appropriate staffing was implemented to care for a patient with a significant change in status,
  • Adequate staff numbers were accounted for in the ICU,
  • That a contingency plan to staff a critical unit was provided,
  • Nurse executive policies were implemented,
  • Nurse executive oversight was provided 24 hours a day, 7 days a week, and
  • A functioning chain of command was in place when the patient suffered a significant change in condition.

Likewise, the Human Resources Director’s conduct fell short when compared against the Joint Commission Standards HR.01.02.05 EP 1, HR .01.04.01 EP 2, HR .01.04.01 EP 4.  Based on these standards, the Human Resources Director failed to:

  • Demonstrate primary source verification of nursing licensure that ultimately revealed lapses in the patient’s primary nurse’s license,
  • Provide education and training to the nursing staff addressing early warning signs of a change in a patient’s condition, and
  • Orient nursing staff on pain management followed by keeping a record of such orientation efforts.

The Pharmacy Director’s conduct compared against The Joint Commission Standard on Medication Management (MM) 05.01.01 EP 1) showed how this employee’s conduct fell below the standards of care.  Contrary to this standard, the Pharmacy Director failed to review new medication orders prior to medication administration and failed to review for existing or potential interactions.

Finally, based on Joint Commission accreditation standards, the nursing expert witness identified that the pharmacy had not updated its high alert and hazardous medication list in two years nor had it implemented a process to manage its high alert and hazardous medications.  The existing list aged by two years listed the administered narcotic as a hazardous medication and the pharmacy agreed the updated list needed to include the narcotic.

  1. Use of Nursing Expert Witness’s Opinions On Regulatory and Accreditation Standards To Rebut Claims Of Health Care Facility Breach In Medical Malpractice Actions.

Regulatory and accreditation standards that reflect the applicable standard of care may likewise effectively be used by hospitals and long-term care facilities to address and rebut claims of breach.  Medical facilities subject to regulatory and accreditation standards, such as CMS policies, may utilize the opinions of nursing experts experienced in health care facility regulations to demonstrate compliance with these standards in defense of malpractice claims.

  1. DEFENSE CASE: Using Regulatory and Accreditation Standards To Demonstrate Long-Term Care Facility’s Compliance With Standard of Care

Facts:  A newly admitted resident to a long-term care facility was being treated for community acquired pressure ulcers.  Over time, she developed an infection in her pressure ulcers and was admitted to the hospital for treatment.

In this case, the nursing administrator expert witness’s knowledge of CMS’s conditions of participation, state law, and accreditation standards enabled her to identify objective evidence that demonstrated how the long-term care facility and its staff employees engaged in appropriate conduct pursuant to standards of care.

The long term care’s compliance with regulatory and accreditation standards of care at the time the resident was under the hospital’s care allowed the hospital to effectively demonstrate that:

  • Infection control measures were operating pursuant to standards of care such as hand hygiene protocols, and isolation procedures.
  • An infection control plan was operating pursuant to standards of care including identification of risks protocols for acquiring and transmitting infections.
  • A plan was in place to reduce risk of infections from medical devices and supplies.
  • An evaluation performance was also in place to show the facility had prevented infections from pressure ulcers over time.

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

  • Standards of care were met in staffing requirements. Despite the patient’s harm, the long-term care facility had hired enough well trained staff.
  • The facility was acting pursuant to standards of care because they had a resident sitter policy that activated when the resident needed constant observation.
  • The resident’s nutritional needs were met pursuant to standards of care because the organization was able to illustrate consistent assessment and reassessment of nutritional needs pursuant to the Centers for Medicare and Medicaid.
  • Lastly, adherence to skin care guidelines were met. In this case, because the facility Director of Nursing and staff nurses met conditions of participation including State code and published skin care guidelines, the defense was able to effectively demonstrate objective evidence that standards of care were met.
  1. Conclusion

Federal and state regulations and accreditation standards are drafted, defined and governed by accreditation and regulatory healthcare organizations that supervise and oversee the professional conduct of medical professional practitioners.

These sources may be relevant in applicable medical malpractice cases against hospitals and health care institutions to demonstrate evidence of the standard of care in all departments related to the case, not just the patient’s first point of contact with the nursing or physician staff.

An experienced nursing administration expert witness with knowledge of these accreditation and regulatory standards can play a valuable role in identifying relevant hospital employees in management and senior leadership positions related to the claims for breach against the hospital, as well as provide a point of comparison to either support or defend claims of breach of applicable standards of care.


Gayle C. Nash is the Chief Nursing Officer for a 168-bed inpatient and outpatient healthcare provider.  She is a former Certified Integrated Nurse Surveyor for the Joint Commission.  In addition to her clinical practice, Ms. Nash serves as a nursing and nursing administration expert witness.  She can be reached at Nash Legal Nurse Consulting, LLC, 269 Fountain Road, El Paso, TX 79912;, (915) 241-7830 (cell) and