News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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There will be more focused lab testing and public reporting of sepsis results as New York State addresses growing problem following death of 12-year-old boy.

New York State will implement tougher standards for the diagnosis and treatment of sepsis in hospitals. One consequence is expected to be more medical laboratory testing for patients suspected of having sepsis.

It may also mean that clinical laboratory test results will get increased scrutiny by physicians who, under the new requirements, must become faster at making an accurate diagnosis of sepsis. These developments were announced by New York Governor Andrew M. Cuomo in his State of the State message on January 9.

New York State First in Nation to Issue Sepsis Standards

This will make New York the first state in the nation to require hospitals to take aggressive steps to manage patients suspected of having sepsis so that treatment can begin sooner. Hospitals in New York must adopt new procedures to identify sepsis. This will include use of a countdown clock to begin treatment within an hour of diagnosis, The New York Times reported in a recent story.

Clinical laboratories in New York hospitals are expected to play a pivotal role in implementing theses new procedures by running tests and delivering results. The regulations could require clinicians to pay close attention to medical laboratory results and order appropriate tests as soon as patients show symptoms.

Some Hospitals Are Emphasizing Lab Tests to Speed Diagnosis

Many New York hospitals have already taken steps to improve the care of patients with sepsis, in part because New York State Health Commissioner Nirav R. Shah, M.D., has made sepsis screening a priority. Sandra Sulik, M.D., Vice President of medical affairs at St. Joseph’s Hospital Health Center in Syracuse, told the Syracuse Post-Standard that the hospital does blood tests to measure patients’ serum lactate levels, an indicator of sepsis, performs blood culture tests to identify the infection and then starts antibiotics.

The regulations for New York State are still being drafted but are likely to require hospitals to report the results of their efforts publicly, the New York Times said. Further, the story noted that last April a failure to review clinical laboratory test results in a timely manner may have played a role in the death of a 12-year-old named Rory Staunton. After being treated in the emergency department (ED) at the New York University Langone Medical Center in New York City, Staunton was diagnosed with a stomach ache and sent home, the Times said.

rory staunton

Rory Staunton, a 12-year-old died of sepsis three days after a visit to the University of New York Langone Medical Center Emergency Department, resulting in the state implementing tougher standards for diagnosing and treating sepsis. Diagnosed with a stomach ache, the boy was released before the attending physician reviewed his lab tests, which showed an elevated white blood cell count indicative of bacterial infection. The case led state officials to begin drafting tougher standards for diagnosing and treating sepsis. (Photo courtesy of Rory Staunton Foundation.)


Three hours later, a clinical laboratory test showed Staunton had a high white blood cell count indicative of bacterial infections, the Times reported. Staunton died three days later. Neither his parents nor his referring pediatrician were told of the medical laboratory results, the newspaper said.

Clinicians Notified as Clinical Laboratory Test Results Are Available

In July, the hospital changed its procedures so that ED physicians and nurses would be notified immediately when lab test results show signs of serious infection. NYU Langone also prepared a checklist to ensure that providers review all critical laboratory results and patient vital signs before the patient is discharged, the hospital said in a statement.

“In the unlikely occurrence that a clinically relevant test is only available after the patient is discharged from the emergency department, the patient will be called, and the information will be shared with the referring physician,” declared hospital spokesperson Lisa Greiner, in a statement issued by NYU Langone Medical Center.

New York State is not alone in its effort to improve the diagnosis and treatment of sepsis. Other organizations are developing guidelines for the treatment of sepsis. In January, the “Surviving Sepsis” Campaign was launched.

It is a collaboration of the Society of Critical Care Medicine and the European Society of Intensive Care Medicine (ESICM). The campaign published guidelines in the Critical Care Medicine Journal.

Medical Laboratory Tests for Lactate Levels and Blood Cultures

The guidelines require that among the steps to be completed within three hours are medical laboratory tests for lactate levels and blood cultures. Also, within six hours, physicians should re-measure lactate levels if initial lactate had been elevated.

Worldwide, hospitalizations for sepsis have more than doubled in the past 10 years. Many countries report that more patients suffer from sepsis than from heart attacks, ESICM said. These factors show that “…early detection and treatment of patients with sepsis has never been more critical,” the society said.

Sepsis is the most common killer in intensive care units, noted Mitchell Levy, M.D., in comments made to The New York Times. He is a researcher at Rhode Island Hospital and coauthored the sepsis treatment guidelines. Levy said the death rate from sepsis is higher than that of breast cancer, lung cancer, and stroke combined.

The Institute for Healthcare Improvement (IHI) in Cambridge, Massachusetts, reported that there are approximately 750,000 new sepsis cases in the United States annually and at least 210,000 (about 28%) are fatal. “Reducing mortality due to severe sepsis requires an organized process that guarantees the early recognition of severe sepsis along with the uniform and consistent application of evidence-based practices,” IHI said. The institute has a guide for clinicians seeking to implement the sepsis management bundle.

Trend Will Continue to Require Better Utilization of Clinical Lab Tests

For pathology and clinical laboratory professionals, these developments reflect the ongoing trend of tightening clinical standards so clinicians can meet the goal of improving patient outcomes. What may give pathologists and lab scientists some cheer from these new sepsis guidelines is that they include requirements that clinicians pay closer attention to medical laboratory test results at the time they are issued by the clinical laboratory that performed the tests. It is widely recognized that a surprisingly high proportion of clinical laboratory test results are never viewed by the physicians who ordered those tests.

—By Joe Burns


Related Information:

Cuomo Plans New Rules in Fight Against Sepsis

Cuomo wants hospitals to use standard screening, treatment to fight sepsis

Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012

Reaction to Column about a Boy Who Died


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