Industry Insights

Rose E. Seavey, RN, BS, MBA, CNOR, ACSP

President & CEO - Seavey Healthcare Consulting, Inc

"The Joint Commission (JC) advises that all hospital policies should be reviewed and or updated at least every three years. In the case of Sterile Processing (SP) every three years for policy updates is not nearly enough.

Some of the most recent updated recommended practices for both the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI) have addressed sterilization monitoring updates which includes, release of regular loads, implants and flash sterilization. A major responsibility of any healthcare provider is to minimize risks to patients. The prudent SP manager should ensure that their policies are up to date and reflective of evidence based practices.

When policy changes are made, they should reflect improvements in practice and patient safety and ought to be referenced to a current standard or recommended practice such as AORN or AAMI. When making policy changes that reflect sterilization monitoring and releasing loads it is extremely important that the all disciplines affected by the policy be involved. Since policy changes may affect patient outcomes, you should involve the Director of the Operating Room, Infection Control, Epidemiology, Risk Management, Quality and Safety, Administration as well as the Surgeons before the policy is changed."

Robert R. Gorbold
Attorney at Law, Kavanagh Grumley & Gorbold LLC

Robert R. Gorbold has tried in excess of 50 cases, primarily before juries, concentrating in the representation of defendants in medical malpractice and products liability matters. He continues an appellate practice. Mr. Gorbold enjoys the distinction of being selected by his peers to the Leading Lawyers Network and as an Illinois Super Lawyer for the past three years. Education: Wheaton College, B.A. (1974), John Marshall Law School, J.D., with distinction (1979) Admitted to Practice: Illinois 1979, U.S. District Court, Northern District of Illinois 1980, U.S. District Court, Central District of Illinois 1995.

The current climate of medical malpractice litigation must be considered when evaluating policies and practices for sterilization of hospital equipment and facilities. While tort reform may offer some protection, hospitals and surgery centers are becoming targets for plaintiffs’ lawyers who are increasingly becoming aware of hospital prevalent infections. Consequently, policies and practices for sterilization of equipment and facilities for the protection of patients will be under increasing scrutiny in the courts.

Medical malpractice is generally defined as a violation of the applicable standard of care. The standard of care is: that which a reasonably well qualified health-care professional would do, or would refrain from doing, in the same or similar circumstances in the same or similar localities. It is applicable to individual health-care professionals as well as hospitals and surgery centers.

In the context of patient injury or death claimed to be caused by a failure to properly sterilize medical equipment and facilities, hospitals and surgery centers can be liable for violations of standard of care by their employees (respondeat superior). They can also be liable for failure to have or enforce appropriate policies or practices (institutional negligence). Given that the hospital or surgery center is the “deep pocket” in most cases and often provides insurance to its staff, institutional negligence will be a primary theory of liability in cases alleging a failure of sterilization causing injury or death.

At trial, evidence of the standard of care is most often presented through the opinions of expert witnesses. Experts testify to applicable regulations and recommendations for patient care and whether the policies and practices of the hospital and surgery center comply. The expert will also testify whether the care of the patient did or did not comply with the standard of care and whether any violation of the standard of care caused plaintiff’s claimed injury and damages.

The most straightforward evidence of standard of care applicable to hospitals and surgery centers is JCAHO requirements and applicable state statutes and regulations. These may be specific but often require or imply sterilization policies and practices which also must meet the evolving recommendations of recognized professional organizations. Liability may be based on either a failure to comply with required policies and practices or a failure to adopt and enforce required policies and practices. Experts will testify that feasible recommendations are part of the standard of care, even if those recommendations have not yet been formally adopted as requirements. The standard of care encompasses both what would be done and what should be done.

With increasing liability exposure, hospitals and surgery centers must be constantly vigilant to adopt and enforce policies and practices that anticipate the constant evolution of the standard of care. Today’s recommendations that are supported by industry experts and recognized professional organizations may be used as evidence in court of the standard of care, even though not yet required by statute or regulation.

Robert R. Gorbold, Attorney at Law, Kavanagh Grumley & Gorbold LLC, may be contacted at 815-727-4511

By: Edwin S. Ross, Chief Executive Officer, Applied Healthcare Research, Inc.,

SITUATION:
There are risks associated with not using Biological Indicators to monitor the releasing of sterilized instruments and supplies. These risks can significantly affect patients, staff and the organization. These risks include the following:

1. Regulatory issues
   1. Joint Commission
   2. Federal Agencies
   3. Center for Medicare / Medicaid Services (CMS
   4. State Regulations
   5. Professional Organizations
2. Infection Control Issues
   1. Patient Harm
   2. Sentinel Event
   3. Extended Hospitalizations
   4. Surveillance Issues
3. Legal and Financial Issues
   1. Reimbursement
   2. Legal Action
   3. Associated Costs

BACKGROUND:
While the above represent a minimum set of risks with the release of sterilized equipment and supplies without adhering to recommended practices and standards, the regulatory issues comprise a primary concern. Without Joint Commission Accreditation, most healthcare organizations would be in jeopardy of losing reimbursement from Medicare and other third party insurers.

There are many Joint Commission Standards that may apply to the subject, below are three Standards with Element of Performance "EP" that apply directly to this subject. These are contained in the chapters called Surveillance, Prevention, and Control of Infection "IC", Leadership "LD" and Environment of Care "EC" from the Comprehensive Accreditation Manual for Hospitals "CAMH".

1. Joint Commission Standards
   1. IC.4.10 EP’s 1 & 3
      1. EP1 - Interventions are designed to incorporate relevant guidelines for infection prevention and control activities.
         1. Referenced are examples of CDC, Healthcare Infection Control Practices Advisory Committee (HIPAC), National Quality Forum, etc.
         2. Joint Commission identifies others under a heading of organizations that would generate best practices such as AORN and AAMI.
         3. The Joint Commission defines Best Practices as "Clinical, scientific, or professional practices that are recognized by a majority of professionals in a particular field. These practices are typically evidence based and consensus-driven”.
      2. EP3 - Methods to reduce the risks associated with procedures, medical equipment, and medical devices, including the following:
         1. Appropriate storage, cleaning, disinfection, sterilization, and/or disposal of supplies and equipment.
         2. The Joint Commission defines Sterilization as “The use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores”.
         3. Reuse of equipment designated by the manufacturer as disposable in a manner that is consistent with regulatory and professional standards.
         4. The Joint Commission defines reprocessing as, “All operations performed to render a contaminated reusable or single-use device patient-ready. The steps may include cleaning and disinfection/sterilization. The manufacturer of reusable devices and single use devices that are marketed as non-sterile should provide validated reprocessing instructions in the labeling.”
   2. LD.1.30 EP1 & 2
      1. EP1 - The hospital provides all care, treatment, and services in accordance with applicable licensure requirements, law, rules, and regulations.
      2. EP2 - The hospital acts upon any reports and/or recommendations from authorized agencies, as appropriate.
   3. LD.4.20 EP4
      1. EP4 – The design of new and modified services or processes are designed well
         1. According to current knowledge, when available and relevant (for example, practice guidelines, successful practices, information from relevant literature and clinical standards).
   4. EC.6.20 EP5
      1. EP5 - The hospital documents performance testing (measurement) of all sterilizers used.
         1. The Joint Commission defines a measurement system as “Measurement systems must be able to generate internal comparisons of organization performance over time, and external comparisons of performance among participating organizations at comparable times.”

ASSESSMENT:
Compliance with Standards - Joint Commission makes it clear through the preceding referenced Standards that it expects organizations it accredits to follow:

1. Joint Commission Standards and Elements of Performance
2. The Standards and EP’s refer to the guidance from Federal, State Laws and Regulations. Thus organizations such as CDC, AAMI and AORN set benchmarks for practices.
3. The Joint Commission expects that Current Knowledge and Best Practices will be incorporated into its accredited organization’s Policies and Procedures.

Joint Commission Survey – By use of the Tracer Methodology, Surveyors are chartered with the responsibility of insuring compliance with the above.

1. They have been trained and are cognizant of the regulations and best practices that are required for accreditation surveys.
2. Surveyors seek to judge compliance through observation, interview and documentation of the sterilization processes as outlined above.
3. When they discover non-compliance, they have no choice but to record such non-compliance and it is considered in the decision making process for accreditation.
4. Furthermore non-compliance would result in a Requirement for Improvement (RFI) which could negatively impact the overall score of the organization and contribute to a Conditional or Preliminary Denial of Accreditation.

RECOMMENDATION:
To reduce risks, Biological Indicator Load Monitoring is required.

1. Organizations should follow Federal, State, and Regulatory Agency requirements.
2. Organizations should design and follow processes and procedures to the level of current knowledge and best practices. Standards organizations such as AAMI and AORN provide nationally recognized standards and recommended practices for the successful reprocessing of reusable medical devices.
3. Professional leaders should implement current best practices and requirements for sterilization.
4. These recommendations both achieve patient safety as well as safe guard the organization.
5. There is no compromise in compliance!