Survey Results Show Progress and Opportunity for Sepsis Protocol Enhancement

According to recent research, many hospitals could use interventional guidance to improve sepsis protocol. A 2023 National Healthcare Safety Network (NHSN) survey found “modest initial progress in resourcing U.S. hospital sepsis programs” compared to the previous year. However, the survey also found that “many opportunities remain to further strengthen hospital sepsis programs to optimize patient care and outcomes.”

The NHSN survey included responses from more than 5,200 hospitals and it found that:

• 78% of hospitals reported having a specific sepsis committee.
• 59% of hospitals said they had “sufficient” time dedicated to sepsis leadership efforts.
• 67% reported that they had enough resources via data analytics.

All of those areas saw improvements in 2023 compared to 2022. However, some key areas of optimal sepsis protocol remain under-resourced. For instance, only 22-23% of hospitals reported that they provided sepsis education during onboarding and yearly sepsis education for certified nursing assistants and patient care technicians. Also, under one-third of hospitals (32%) reported “standardized processes for verbal hand-off,” according to the survey.

Executive leadership remains a big challenge as well. Smaller facilities, in particular, struggle to provide the vital leadership commitment they need to bolster sepsis protocol. While 78% of larger facilities (more than 500 beds) “indicated that sepsis program leaders were provided sufficient specified time to manage the hospital sepsis program,” just 41% of the smallest facilities reported the same, according to the NHSN survey.

7 Core Elements of an Effective Sepsis Protocol

The NHSN survey helped inform the CDC about facilities’ general awareness and aptitude with best-practice sepsis protocol. In August 2023, the agency released the Hospital Sepsis Program Core Elements, a lengthy, multifaceted roadmap centered around seven core elements meant to “aid in the fast recognition of sepsis, facilitate the implementation of evidence-based management of sepsis and support the recovery of patients after sepsis,” according to the CDC. Those seven core elements, along with a brief description, are:

1. Hospital Leadership Commitment

Dedicating the necessary human, financial, and information technology resources.

2. Accountability

Appointing a leader or co-leaders responsible for program goals and outcomes.

3. Multi-professional Expertise

Engaging key partners throughout the hospital and healthcare system.

4. Action

Implementing structures and processes to improve the identification of management of, and recovery from sepsis.

5. Tracking

Measuring sepsis epidemiology, management, and outcomes to assess the impact of sepsis initiatives and progress toward program goals.

6. Reporting

Providing information on sepsis management and outcomes to relevant partners.

7. Education

Providing sepsis education to healthcare professionals, patients, and family/caregivers.

Leadership Buy-In: A Cornerstone of a Successful Sepsis Protocol

The CDC considers buy-in from hospital leadership one of the most important elements of a successful sepsis program. For hospitals just getting started in building an optimal sepsis protocol, the agency posits that they should first identify a sepsis program leader; ensure support from the leadership or executive team; perform a “needs analysis” to pinpoint existing protocols and treatment processes, as well as gaps in such protocols; and from there develop sepsis program goals, both short- and longer-term.

Other facilities may be farther along in their sepsis program journey, but as the NHSN survey shows, there remains room for improvement.

Five Essential Areas for Improving Sepsis Practices

The CDC cites research into five ever-important areas, primarily related to staff education, empowerment, and collaboration, that are “critical for improving the delivery of recommended sepsis practices.” In short, those five areas are:

1. Staff knowledge. Hospital staff knowing what to do and why.
2. Treatment focus. Hospital staff being aware of risks and benefits of treatment options.
3. Collaborative spirit. Hospital staff working closely together in a collaborative effort across roles.
4. Empowerment and support. Hospital stuff must have the backing of leadership team.
5. Adequate staffing. Simply put, hospitals must have enough staff to run an effective program.

Leveraging the CDC’s Hospital Sepsis Program Core Elements

The seven “core elements” that comprise the CDC’s hospital sepsis program contain a plethora of details about each one, as well as “priority examples” that give hospital leaders an inside look at how to establish or bolster an effective sepsis protocol. For example, within the “Hospital Leadership Commitment” core element, the agency offers multiple priority examples of what that commitment looks like, e.g., “providing resources, including data analytics and information technology support, to operate the program effectively,” and “appointing a senior administrator (e.g., Chief Clinical Officer, Chief Medical Officer or Chief Nursing Officer) to serve as an executive sponsor for the sepsis program,” among many others.

Under the “Accountability” core element, the agency says that “we strongly recommend sepsis programs be co-led by a physician and a nurse.” Within the “Action” core element, the CDC urges hospitals to implement “a standardized process to screen for sepsis” and provides a link to hospital-based screening tools, as well as numerous sepsis management examples from organizations such as MD Anderson Cancer Center and Intermountain Healthcare.

With the strength of such guideline documents as the CDC’s core elements and others, hospital leaders can move sepsis protocol forward and deliver improved clinical care for some of the most at-risk patients.

You may also like:

• Free Sepsis & Septic Shock Checklists
• How AI in Medical Diagnostics Is Transforming Healthcare and Reducing Medical Errors
• Closing the Skill Gap: 5 Tactics to Improve Your Healthcare Quality and Patient Safety Teams’ Competencies

Why the HIPAA Right to Access Matters

According to Office for Civil Rights (OCR) Director Melanie Fontes Rainer, the agency receives “thousands of complaints each year” pertaining to the HIPAA Right to Access rule. “Access to medical records empowers patients and their families to make decisions about their health care and improve their health overall,” Rainer said in a recent settlement announcement.

Recent penalties highlight the urgency for healthcare organizations to prioritize compliance. For instance:

• In its latest Report to Congress on HIPAA Privacy, Security and Breach Notification Rule Compliance, covering CY 2022, OCR cited more than 15 Right to Access resolution agreements and civil money penalties. That includes a $240,000 settlement with Memorial Hermann Health System, a 17-hospital system in Texas.
• Optum Medical Care settled for $160,000 in December 2023 for months-long delays in providing medical records.

The Optum Medical Care settlement marked the 46th enforcement action related to HIPAA Right to Access provisions since the OCR settled its first case in 2019, an $85,000 settlement with Bayfront Health St. Petersburg, which occurred after the agency launched its enforcement program earlier that year.

With HIPAA Right to Access provisions a key compliance focus for the OCR, hospital leaders must be fully aware of what the standard entails, how their organizations can stay in line with various regulations, and remain in compliance with the provision to achieve the OCR’s aims of attaining quality improvement in healthcare.

Key HIPAA Right to Access Provisions You Need to Know

Understand the “Designated Record Set.”

Under the Right to Access provision, patients possess general rights that hospitals and medical groups must comply with. The Privacy Rule requires that, upon request, covered entities (CE), such as health care providers and health plans, grant access to the patient’s protected health information (PHI) in the form of a “designated record set,” which has its own set of definitions. By law, as it relates to a provider CE, the designated record set consists of:

• Medical records and billing records.
• Other records that are used in the course of medical decision-making, such as clinical laboratory tests, medical images (e.g., X-rays), clinical case notes or disease management case files.

While CEs are required to be able to share the various elements that make up the designated record set, they are “not, however, required to create new information, such as explanatory materials or analyses, that does not already exist,” OCR explains.

Two broad categories are excluded from HIPAA Right to Access medical record sharing: psychotherapy notes and any information that is being used or is anticipated to be used in a civil, criminal or administrative action.

Know the Right to Access Timelines.

Many of the penalties that OCR has doled out under the HIPAA Right to Access provision in recent years have rested on the timeliness factor. OCR maintains a clear timeline: CEs must provide access to the requested PHI no later than 30 calendar days from the date of the request. Ideally, the request would be met sooner: “The 30 calendar days is an outer limit and covered entities are encouraged to respond as soon as possible,” the OCR states.

Focus on Form and Format.

CEs must defer to the form and format that the requestor identifies so long as that format is “readily producible.” If the patient (or representative) requests a paper copy of PHI, the CE is expected to provide the PHI in a paper copy format, even if the CE maintains the PHI electronically. If the patient (or representative) requests an electronic copy, OCR expects the CE to furnish an electronic copy, even if the CE maintains only paper records (again, if it is “readily producible”). If it is not readily producible, the CE may provide a hard copy format.

Fees Are OK, But They Are Limited.

CEs are permitted to charge the patient (or representative) a “reasonable, cost-based fee” but that fee is limited to specific tasks: the labor involved in copying the PHI; supplies used for creating an electronic copy; postage; and preparation of an explanation or summary, if requested. OCR permits CEs to charge a flat fee not to exceed $6.50 when sharing electronic PHI. Alternatively, CEs may charge for fees larger than that if the CE calculates costs or uses a schedule of allowable costs.

Sharing with Third Parties and Personal Representatives.

OCR allows an individual’s personal representative to request and receive PHI and also to request a transmission of the PHI to third parties. Generally speaking, the patient’s personal representation is “a person with authority under state law to make health care decisions for the individual,” according to the OCR. Under the HIPAA privacy rule, a parent is considered a child’s personal representative.

For CEs, they must comply with requests to send PHI to a third party. “The same requirements for providing the PHI to the individual, such as the timeliness requirements, fee limitations, prohibition on imposing unreasonable measures, and form and format requirements, apply when an individual directs that the PHI be sent to another person or entity,” OCR states.

Avoiding costly penalties by staying in line with HIPAA Right to Access standards is critical for hospital leaders and a key component of their mission in achieving quality in healthcare.

To learn more about the Right to Access standards, view a series of FAQs and recent clarifications to the provision.