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Clinical Laboratories and Pathology Groups

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New Federal Rules on Sepsis Treatment Could Cost Hospitals Millions of Dollars in Medicare Reimbursements

Some hospital organizations are pushing back, stating that the new regulations are ‘too rigid’ and interfere with doctors’ treatment of patients

In August, the Biden administration finalized provisions for hospitals to meet specific treatment metrics for all patients with suspected sepsis. Hospitals that fail to meet these requirements risk the potential loss of millions of dollars in Medicare reimbursements annually. This new federal rule did not go over well with some in the hospital industry.

Sepsis kills about 350,000 people every year. One in three people who contract the deadly blood infection in hospitals die, according to the Centers for Disease Control and Prevention (CDC). Thus, the federal government has once again implemented a final rule that requires hospitals, clinical laboratories, and medical providers to take immediate actions to diagnose and treat sepsis patients.

The effort has elicited pushback from several healthcare organizations that say the measure is “too rigid” and “does not allow clinicians flexibility to determine how recommendations should apply to their specific patients,” according to Becker’s Hospital Review.

The quality measures are known as the Severe Sepsis/Septic Shock Early Management Bundle (SEP-1). The regulation compels doctors and clinical laboratories to:

  • Perform blood tests within a specific period of time to look for biomarkers in patients that may indicate sepsis, and to
  • Administer antibiotics within three hours after a possible case is identified.

It also mandates that certain other tests are performed, and intravenous fluids administered, to prevent blood pressure from dipping to dangerously low levels. 

“These are core things that everyone should do every time they see a septic patient,” said Steven Simpson, MD, Professor of medicine at the University of Kansas told Fierce Healthcare. Simpson is also the chairman of the Sepsis Alliance, an advocacy group that works to battle sepsis. 

Simpson believes there is enough evidence to prove that the SEP-1 guidelines result in improved patient care and outcomes and should be enforced.

“It is quite clear that this works better than what was present before, which was nothing,” he said. “If the current sepsis mortality rate could be cut by even 5%, we could save a lot of lives. Before, even if you were reporting 0% compliance, you didn’t lose your money. Now you actually have to do it,” Simpson noted.

Chanu Rhee, MD

“We are encouraged by the increased attention to sepsis and support CMS’ creation of a sepsis mortality measure that will encourage hospitals to pay more attention to the full breadth of sepsis care,” Chanu Rhee, MD (above), Infectious Disease/Critical Care Physician and Associate Hospital Epidemiologist at Brigham and Women’s Hospital told Healthcare Finance. The new rule, however, requires doctors and medical laboratories to conduct tests and administer antibiotic treatment sooner than many healthcare providers deem wise. (Photo copyright: Brigham and Women’s Hospital.)

Healthcare Organizations Pushback against Final Rule

The recent final rule builds on previous federal efforts to combat sepsis. In 2015, the Centers for Medicare and Medicaid Services (CMS) first began attempting to reduce sepsis deaths with the implementation of SEP-1. That final rule updated the Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospitals Prospective Payment System (LTCH PPS).

Even then the rule elicited a response from the American Hospital Association (AHA), the Infectious Disease Society of America (IDSA), American College of Emergency Physicians (ACEP), the Society of Critical Care Medicine (SCCM), and the Society of Hospital Medicine (SHM). The organizations were concerned that the measure “encourages the overuse of broad-spectrum antibiotics,” according to a letter the AHA sent to then Acting Administrator of CMS Andrew Slavitt.

“By encouraging the use of broad spectrum antibiotics when more targeted ones will suffice, this measure promotes the overuse of the antibiotics that are our last line of defense against drug-resistant bacteria,” the AHA’s letter states.

In its recent coverage of the healthcare organizations’ pushback to CMS’ final rule, Healthcare Finance News explained, “The SEP-1 measure requires clinicians to provide a bundle of care to all patients with possible sepsis within three hours of recognition. … But the SEP-1 measure doesn’t take into account that many serious conditions present in a similar fashion to sepsis … Pushing clinicians to treat all these patients as if they have sepsis … leads to overuse of broad-spectrum antibiotics, which can be harmful to patients who are not infected, those who are infected with viruses rather than bacteria, and those who could safely be treated with narrower-spectrum antibiotics.”

CMS’ latest rule follows the same evolutionary path as previous federal guidelines. In August 2007, CMS announced that Medicare would no longer pay for additional costs associated with preventable errors, including situations known as Never Events. These are “adverse events that are serious, largely preventable, and of concern to both the public and healthcare providers for the purpose of public accountability,” according to the Leapfrog Group.

In 2014, the CDC suggested that all US hospitals have an antibiotic stewardship program (ASP) to measure and improve how antibiotics are prescribed by clinicians and utilized by patients.

Research Does Not Show Federal Sepsis Programs Work

In a paper published in the Journal of the American Medical Association (JAMA) titled, “The Importance of Shifting Sepsis Quality Measures from Processes to Outcomes,” Chanu Rhee, MD, Infectious Disease/Critical Care Physician and Associate Hospital Epidemiologist at Brigham and Women’s Hospital and Associate Professor of Population Medicine at Harvard Medical School, stressed his concerns about the new regulations.

He points to analysis which showed that though use of broad-spectrum antibiotics increased after the original 2015 SEP-1 regulations were introduced, there has been little change to patient outcomes.  

“Unfortunately, we do not have good evidence that implementation of the sepsis policy has led to an improvement in sepsis mortality rates,” Rhee told Fierce Healthcare.

Rhee believes that the latest regulations are a step in the right direction, but that more needs to be done for sepsis care. “Retiring past measures and refining future ones will help stimulate new innovations in diagnosis and treatment and ultimately improve outcomes for the many patients affected by sepsis,” he told Healthcare Finance.

Sepsis is very difficult to diagnose quickly and accurately. Delaying treatment could result in serious consequences. But clinical laboratory blood tests for blood infections can take up to three days to produce a result. During that time, a patient could be receiving the wrong antibiotic for the infection, which could lead to worse problems.

The new federal regulation is designed to ensure that patients receive the best care possible when dealing with sepsis and to lower mortality rates in those patients. It remains to be seen if it will have the desired effect.  

Jillia Schlingman

Related Information:

Feds Hope to Cut Sepsis Deaths by Hitching Medicare Payments to Treatment Stats

Healthcare Associations Push Back on CMS’ Sepsis Rule, Advocate Tweaks

Value-Based Purchasing (VBP) and SEP-1: What You Should Know

NIGMS: Sepsis Fact Sheet

CDC: What is Sepsis?

CDC: Core Elements of Antibiotic Stewardship

The Importance of Shifting Sepsis Quality Measures from Processes to Outcomes

Association Between Implementation of the Severe Sepsis and Septic Shock Early Management Bundle Performance Measure and Outcomes in Patients with Suspected Sepsis in US Hospitals

Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure

CMS to Improve Quality of Care during Hospital Inpatient Stays – 2014

Microbial Surveillance Study Snares Patients Entering Michigan Hospitals with Drug-Resistant Bacteria on Their Hands

Thorough hand-washing protocols aren’t just for healthcare professionals anymore. Patients also need to be educated to prevent hospital-acquired infections

Microbiologists and clinical laboratory managers will be particularly interested to learn that patients are bringing deadly organisms into hospitals on their hands. That’s the conclusion of a University of Michigan (UM) study which found that as patients enter and move throughout hospitals, they deposit and spread multi-drug resistant organisms, or MDROs on clinical surfaces. When those surfaces are not properly decontaminated, the bacterial contamination spreads on contact.

This finding has implications for the nosocomial infection teams in hospitals that include microbiologists and clinical laboratories. After all, every day there is a large flow of walk-in patients and visitors who come in contact with dozens of surfaces. The potential for contamination with multi-drug resistant organisms is high.

Antibiotic-resistant bacteria have been the root cause of a marked increase in hospital-acquired infections (HAIs), which Dark Daily has covered extensively. That’s why healthcare professionals practice proper hand-washing protocols to help reduce the transmission of pathogens and curtail possible infections.

The UM study, however, suggests that patients also should be educated on proper hand hygiene to diminish the potential spread of bacteria, especially before making trips to the emergency room.

The UM researchers published their study in the Oxford Academic journal Clinical Infectious Diseases.

How to Kill a Superbug

Between February and July of 2017, UM researchers at two hospitals in Southeast Michigan tested 399 general medicine hospital patients for the presence of MDROs, also known as superbugs. They swabbed the palms, fingers, and around the nails of the patients’ dominant hands and the interior of both nostrils.

The researchers found that 14% of the patients tested positive for MDROs. In addition, nearly one third of high-touch objects and surfaces in the hospital rooms tested positive for superbugs as well.  

The hospital room surfaces that were swabbed for the presence of MDROs were:

  • Bed control/bed rail;
  • Call button/television remote;
  • Bedside tray table top;
  • Telephone;
  • Toilet seat; and
  • Bathroom door knob.

The research team specifically looked for:

Due to the overuse of antibiotics, these types of bacteria are often resistant to the drugs that were once used to kill them.

“Hand hygiene narrative has largely focused on physicians, nurses, and other frontline staff, and all the policies and performance measurements have centered on them, and rightfully so,” said Lona Mody, MD (above) in a press release. Mody is Professor of Internal Medicine at UM and one of the lead researchers for the study. “But our findings make an argument for addressing transmission of MDROs in a way that involves patients, too.”

Anatomy of a Hospital-Acquired Infection

The scientists tested patients and surfaces at different stages of their hospital stays. The samples were taken on the day of admission, days three and seven of the stays, and weekly thereafter until the patients were discharged.

The team found that 6% of the patients who did not have MDROs present at the beginning of their hospital stays tested positive for superbugs at later stages of their stays. Additionally, 20% of the tested objects and surfaces in the patients’ rooms had superbugs on them at later test stages that were not present earlier in the hospital stays.

“This study highlights the importance of hand washing and environmental cleaning, especially within a healthcare setting where patients’ immune systems are compromised,” noted Katherine Reyes, MD, Department of Infectious Diseases, Henry Ford Hospital, in the press release. “This step is crucial not only for healthcare providers, but also for patients and their families. Germs are on our hands; you do not need to see to believe it. And they travel. When these germs are not washed off, they pass easily from person to person and objects to person and make people sick.”

Patients included in the study had to be new admissions, on general medicine floors, and at least 18 years of age. Criteria that excluded individuals from participation in the research included:

  • Being in observation status, typically after a medical procedure;
  • Transfers from other hospitals;
  • Transfers from intensive care units;
  • Having cystic fibrosis (these patients have a higher likelihood of MDRO colonization);
  • Receiving end-of-life care; and
  • Non-English speaking.

Patients who were transferred to a room on a nonparticipating floor within the hospitals were immediately discharged from the study. 

Patients Travel Throughout Hospitals Spreading Germs

The presence of superbugs on patients or surfaces does not automatically translate to a patient getting sick with antibiotic-resistant bacteria. Only six of the patients in this study developed MRSA. However, all six of those individuals tested positive for the superbug either on their hands or on surfaces within their room. 

The researchers noted that hospital patients typically do not stay in their rooms. They are encouraged to walk throughout the hospital to speed up the recovery process, and often are transported to other areas of hospitals for medical tests and procedures. Patients also may be picking up superbugs from other patients and staff members, other hospital areas, and commonly-touched surfaces.

The UM researchers concluded in their study that “while the burden of preventing infections has largely been borne by [healthcare personnel], our study shows that patient hands are an important reservoir and play a crucial role in the transmission of pathogens in acute care hospitals. Thus, patient hand hygiene protocols should be implemented and tested for their ability to reduce environmental contamination, pathogen transmission, and healthcare-associated infections, as well as to increase meaningful patient engagement in infection prevention.”

“Infection prevention is everybody’s business,” stated Mody in the press release. “We are all in this together. No matter where you are, in a healthcare environment or not, this study is a good reminder to clean your hands often, using good techniques—especially before and after preparing food, before eating food, after using a toilet, and before and after caring for someone who is sick—to protect yourself and others.”

These research findings should prove to be valuable for infection control teams and microbiology laboratories in the nation’s hospitals and health systems, as well as independent clinical laboratories, urgent care centers, and retail healthcare clinics.

Learning more about the transmission of infectious agents from patient to patient and from surfaces to patients could aid in the development of new techniques and strategies to prevent superbugs from manifesting in medical environments.

—JP Schlingman

Related Information:

‘Superbugs’ Found on Many Hospital Patients’ Hands and What They Touch Most Often

Multidrug-resistant Organisms in Hospitals: What Is on Patient Hands and in Their Rooms?

Unexpected Discovery of Source of Lethal, Antibiotic-Resistant Strain of E. Coli Could Lead to New Medical Laboratory Tests and Preventative Treatment

Lurking Below: NIH Study Reveals Surprising New Source of Antibiotic Resistance That Will Interest Microbiologists and Medical Laboratory Scientists

Pathologists and Clinical Laboratories to Play Critical Role in Developing New Tools to Fight Antibiotic ResistanceCould Proximity of Toilets to Sinks in Medical Intensive Care Units Contribute to Hospital-Acquired Infections?

Study Shows How Simple Changes in Reporting Medical Laboratory Test Results to Clinicians Improve Patient Safety and Reduce Inappropriate Use of Antibiotics

Researchers focused on whether different ways of reporting clinical laboratory test results would improve care for patients at low risk for developing urinary tract infections

Simple changes in how clinical laboratory tests are reported to clinicians can contribute to improved patient safety and a reduction in the inappropriate use of antibiotics. These were the conclusions of a recent study published in the Infectious Diseases Society of America’s (IDSA) peer-reviewed medical journal, Clinical Infectious Diseases (CID).

If the findings of this study can be duplicated in other settings, it can provide pathologists and medical laboratory scientists with another approach to improve the way clinicians utilize clinical laboratory tests so as to improve patient outcomes and reduce the associated cost of care. (more…)

Raising the Performance Bar for Hospital Infection Control

As more attention is paid to reducing the number of healthcare-associated infections (HIAs), hospitals and health systems respond with proactive programs to eliminate many obvious sources of such infections. In turn, this affects hospital laboratories, since they play a key role in every hospital’s infection control program.

The basic statistics are stunning. Hospital-acquired infections (HIAs) affect nearly 2 million Americans annually, resulting in 90,000 deaths and up to $6.5 billion in extra costs, according to the Centers for Disease Control (CDC).