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CMS Pauses Plans to Limit Public Knowledge of Medical and Surgical Harm at Hospitals During COVID-19 Pandemic

Healthcare industry watchdog Group Leapfrog says that if CMS suppresses the data “all of us will be in the dark on which hospitals put us most at risk”

For some time, hospitals and clinical laboratories have struggled with transparency regulation when it comes to patient outcomes, test prices, and costs. So, it is perplexing that while that Centers for Medicare and Medicaid Services (CMS) pushes for more transparency in the cost of hospital care and quality, the federal agency also sought to limit public knowledge of 10 types of medical and surgical harm that occurred in hospitals during the COVID-19 pandemic.

And even though the CMS announced in its August 1 final rule (CMS-1771-F) that it was “pausing” its plans to suppress data relating to 10 measures that make up the Patient Safety and Adverse Events Composite (PSI 90), a part of the Hospital-Acquired Condition (HAC) Reduction Program, it is valuable for hospital and medical laboratory leaders to understand what the federal agency was seeking to accomplish.

COVID-19’s Impact on Measure Data

Within its lengthy 2023 Hospital Inpatient Prospective Payment System and Long Term Care Hospitals Proposed Rule (CMS-1771-P), the federal agency cites the COVID-19 public health emergency (PHE) as a reason for the adjustment in public access to certain data.

According to USA Today, medical complications at hospitals such as pressure ulcers and falls leading to fractures would be suppressed in reports starting next year. Additionally, CMS “also would halt a program to dock the pay of the worst performers on a list of safety measures, pausing a years-long effort that links hospitals’ skill in preventing such complications to reimbursement,” Kaiser Health News reported.

The proposed rule’s executive summary reads in part, “Due to the impact of the COVID-19 PHE on measure data used in our value-based purchasing (VBP) programs, we are proposing to suppress several measures in the Hospital VBP Program and HAC Reduction Program … If finalized as proposed, for the FY 2023 program year, hospitals participating in the HAC Reduction Program will not be given a measure score, a Total HAC score, nor will hospitals receive a payment penalty.”

These 10 measures include:

  • PSI 03-Pressure Ulcer Rate
  • PSI 06-Iatrogenic Pneumothorax Rate
  • PSI 08-In Hospital Fall with Hip Fracture Rate
  • PSI 09-Perioperative Hemorrhage or Hematoma Rate
  • PSI 10-Postoperative Acute Kidney Injury Requiring Dialysis Rate
  • PSI 11-Postoperative Respiratory Failure Rate
  • PSI 12-Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate
  • PSI 13-Postoperative Sepsis Rate
  • PSI 14-Postoperative Wound Dehiscence Rate
  • PSI 15-Abdominopelvic Accidental Puncture/Laceration Rate

The measures would not be accessible to the public or appear on the CMS Hospital Compare website, MedPage Today added.

“Those 10 events account for 25,000 preventable deaths and 94,000 incidents of patient harm in the US annually, according to recent analyses,” Fortune reported.

In a fact sheet, CMS noted that its intent in proposing the rule was neither to reward nor penalize providers at a time when they were dealing with the SARS-CoV-2 outbreak, new safety protocols for staff and patients, and an unprecedented rise in inpatient cases.

Lee Fleisher, MD
“We want the public to have complete trust in the data and will only be providing data we have determined has a high confidence of credibility and accuracy,” said CMS Chief Medical Officer Lee Fleisher, MD (above), Director of the CMS Center for Clinical Standards and Quality in a statement, Axios reported. Clinical laboratory leaders would find it more difficult to compare the performance of their hospitals against peer hospitals, should this proposed rule take effect as written. (Photo copyright: Lee Fleisher.)

Groups Opposed to the CMS Proposal

Like healthcare costs, quality data need to be accessible to the public, according to a health insurance industry representative. “Cost data, in the absence of quality data, are at best meaningless, and at worst, harmful. We see this limitation on collection and publication of data about these very serious safety issues as a step backward,” Robert Andrews, JD, CEO, Health Transformation Alliance, told Fortune.

The Leapfrog Group, a Washington, DC-based non-profit watchdog organization focused on healthcare quality and safety, urged CMS to reverse the proposal. The organization said on its website that it had collected 270 signatures on letters to CMS.

“Dangerous complications, such as sepsis, kidney harm, deep bedsores, and lung collapse, are largely preventable yet kill 25,000 people a year and harm 94,000,” wrote the Leapfrog Group in a statement. “Data on these complications is not available to the public from any other source. If CMS suppresses this data, all of us will be in the dark on which hospitals put us most at risk.”

Leah Binder, Leapfrog President/CEO, told MedPage Today she is concerned the suppression of public reporting of safety data may continue “indefinitely” because CMS does not want “to make hospitals unhappy with them.”

AHA Voices Support

Meanwhile, the American Hospital Association noted that the CMS “has made this proposal to forgo calculating certain hospital bonuses and penalties due to the impact of the pandemic,” Healthcare Dive reported.

“We agree with CMS that it would be unfair to base hospital incentives and penalties on data that have been skewed by the unprecedented impacts of the pandemic,” said Akin Demehin, AHA Senior Director, Quality and Safety Policy, in a statement to Healthcare Dive.

Though CMS’ plans to limit public knowledge of medical and surgical complications have been put on hold, medical laboratory leaders will want to stay abreast of CMS’ next steps with this final rule. Suppression of hospital harm during a period of increased demand for hospital transparency could trigger a backlash with healthcare consumers.

Donna Marie Pocius


Related Information:

CMS Final Rule CMS-1771-F

CMS Announces Continued Public Reporting of PSI 90 and Commitment to Transparency

Patient Safety Advocate Cheers CMS’ Reversal on Quality Reporting, But Hospitals Say the Data Are No Good

Medicare Ditches Plan to Bury Hospital Safety Data Next Year

FY 2023 Hospital Inpatient Prospective Payment System and Long-Term Care Hospitals Proposed Rule (CMS-1771-P)

Groups Object to Medicare Push to Suppress Reporting of Harm Done to Patients at Hospitals

CMS Proposal to Suppress Hospital Safety Data Angers Advocates

Fact Sheet: FY 2023 Hospital Inpatient Prospective Payment System and Long-Term Care Hospitals Proposed Rule (CMS-1771-P)

Biden Administration Seeks to Suppress Hospital Safety Data

Lives Lost, Lives Saved: An Updated Comparative Analysis of Avoidable Deaths at Hospitals Graded by The Leapfrog Group

Patient Safety Indicators (PSI) Benchmark Data Tables, v2021

Hospitals Have Become Less Safe During the Pandemic; So Why Does the Government Want to Suppress Hospital Safety Data?

We Need Your Help: Don’t Let CMS Suppress 25,000 Deaths a Year in Hospitals

Leapfrog Raises Concerns About CMS Proposal to Suppress Patient Safety Data

CMS Ready to Add Three More Items to Never Events No-Pay Policy for Medical Errors

Despite the Coronavirus Pandemic, Medicare Officials Continue Push for Price Transparency by Pressuring Hospitals to Disclose Rates Negotiated with Private Payers

Leapfrog Group Report Shows Hospitals Failing to Eliminate Hospital-Acquired Infections; Medical Laboratories Can Help Providers’ Antimicrobial Stewardship Programs

Contrary to CMS and Joint Commission programs implemented in 2017 to reduce them, incidents of hospital-acquired infections have risen for the past few years

Clinical laboratories and anatomic pathologists know that hospital-acquired infections (HAIs) can be deadly, not just for patients, but for their caregivers and families as well. Even one HAI is too many. Thus, the federal Centers for Medicare and Medicaid Services (CMS) required healthcare organizations to upgrade their antimicrobial stewardship (AMS) programs to meet CMS requirements and Joint Commission accreditation starting in 2017.

Nevertheless, a recent Leapfrog Group report indicates hospitals are finding it increasingly difficult to remove infections all together. This has many healthcare leaders concerned.

The report, which was analyzed by Castlight Health, states that the number of hospitals reporting zero infections has declined significantly since 2015, according to a news release. According to the Leapfrog Group’s report:

  • Two million people acquire HAIs every year;
  • 90,000 people die annually from HAIs;
  • HAI costs range from $1,000 to $50,000 depending on the infection.

Hospitals spend $28 to $45 billion annually on HAI costs, Healthcare Finance reported.

“I think it’s far too easy to let something slip, so it’s clear that there really needs to be a renewed focus on getting back to zero. We do still see some hospitals that are getting to zero, so it’s clearly possible,” Erica Mobley (above), Leapfrog Group’s Director of Operations, told Fierce Healthcare. (Photo copyright: LinkedIn.)

Regressing Instead of Progressing Toward Total HAI Elimination

Leapfrog Group’s report is based on 2017 hospital survey data submitted by 2,000 providers. The data indicates that in just two years the number of hospitals reporting zero HAIs dropped by up to 50%. The reported HAIs include:

The remaining infection measures studied by Leapfrog Group had less dramatic decreases over the same time period, according to Fierce Healthcare. Nevertheless, they are significant. They include:

  • Surgical site infections (SSI) following colon surgery: 19% zero infections compared to 23% previously;
  • Clostridium difficile (C. difficile) inpatient infections: 3% zero inpatient infections in 2017, compared to 5% in 2015.

Joint Commission Studies Antimicrobial Program Progress

Meanwhile, the Joint Commission acknowledged that implementation of antimicrobial stewardship programs by providers can be difficult. In “The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multisite Qualitative Study,” the accrediting organization released insights from interviews with 12 antimicrobial stewardship program leaders nationwide.

They published their study in “The Joint Commission Journal on Quality and Patient Safety.” Three themes emerged from the interviews:

  • Hospitals have revised their antimicrobial programs, which originally operated on a “top-down” structure, to programs that include clinicians from throughout entire provider organizations;
  • Health information technology (HIT) can enable real-time opportunities to launch antimicrobial therapy and treat patients; and,
  • Some barriers exist in getting resources to integrate technology and analyze data.

“These programs used expansion of personnel to amplify the antimicrobial stewardship programs’ impact and integrated IT resources into daily workflow to improve efficiency,” the researchers wrote. “Hospital antimicrobial stewardship programs can reduce inappropriate antimicrobial use, length of stay, C. difficile infection, rates of resistant infections, and cost.”

What Do CMS and Joint Commission Expect?

According to Contagion, while the Joint Commission program is part of medication management, CMS places its requirements for the antimicrobial stewardship program under “infection prevention.”

CMS requirements for an antimicrobial stewardship program include:

  • Developing antimicrobial stewardship program policies and procedures;
  • Implementing hospital-wide efforts;
  • Involving antimicrobial stakeholders for focus on antimicrobial use and bacterial resistance;
  • Setting evidence-based antimicrobial use goals; and,
  • Reducing effects of antimicrobial use in areas of C. difficile infections and antibiotic resistance.

Leapfrog Group’s data about fewer hospitals reporting zero infections offers opportunities for hospital laboratory microbiology professionals to get involved with hospital-wide antimicrobial program teams and processes and help their hospitals progress back to zero HAIs. Clinical laboratories, both hospital-based and independent, also have opportunities to contribute to improving the antimicrobial stewardship efforts of the physicians who refer them specimens.

—Donna Marie Pocius

Related Information:

Troubling New Report on Hospital Infections Comes While Centers Medicare and Medicaid Services Considers Discontinuing Publicly Reporting Rates

Leapfrog Group: Healthcare-Associated Infections

Antimicrobial Stewardship Standards: A Comparison of Centers for Medicare and Medicaid Services and Joint Commission Requirements

Joint Commission: New Antimicrobial Stewardship Standard

Core Elements of Hospital Antibiotic Stewardship Programs

Number of Hospitals Achieving Zero Infections Drops

Hospitals Losing Ground on Effectively Preventing Infections with Dramatic Drop in Those Reporting Zero Infections

The Expanding Role of Antimicrobial Stewardship Programs in Hospitals in the United States: Lessons Learned from a Multi-Site Qualitative Study

Leapfrog Group CEO Wants Healthcare Professionals to Stop Rallying Behind Quality Measure Critics

Binder argues that groups opposing ‘value’ often diminish clinicians’ role in hospital quality and patient outcomes; clinical labs often have the data on the outcomes generated by different clinicians

As healthcare moves steadily toward a value-based reimbursement model, Leapfrog Group CEO Leah Binder is urging healthcare providers to rethink their opposition to quality measures and criteria that reward improved medical outcomes.

“Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder stated in an editorial she penned for Modern Healthcare. “Value will succeed either way, but it will be so much better infused with the knowledge and gifts of practicing providers.”

Many clinical laboratory managers and pathologists know that the Leapfrog Group carries quite a bit of clout in healthcare. Its members include some of the largest corporations in the United States. Collectively, Leapfrog’s members provide health benefits to more than 37 million Americans in all 50 states, and spend tens of billions of dollars on healthcare each year, according to this 2009 Leapfrog Group Fact Sheet. This is why health insurers, hospitals, and physicians pay attention to Leapfrog’s programs and public statements.

“If all hospitals implemented just the first three of Leapfrog’s four ‘leaps’ (our recommended quality and safety practices): over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12.0 billion could be saved each year,” states the fact sheet.

Physician Opposition to Value-based Reimbursement Models Will Backfire

Leapfrog’s Binder argues the value-based reimbursement movement will succeed for three reasons:

1. “Value” is enshrined in the Affordable Care Act, with the Centers for Medicare and Medicaid Services (CMS) now tying almost 6% of hospital Medicare reimbursement to performance, and Congress replacing the sustainable growth-rate (SGR) with a value-based formula.

2. Private insurers also are transitioning their payment models, with 40% of commercial payments linked to value, up from 9% a year earlier. In addition, consumers, who are paying more out of pocket, are increasingly sensitive to value.

3. Big data is enabling quality to be quantified. Binder pointed to the leadership of the National Quality Forum (NQF) and others in showing “we can defensibly measure the quality side of the value equation.”

Binder warns that arguments made in the name of clinicians to denounce specific quality measures can backfire. In particular, she pointed to a study published in the BMJ that concluded clinicians have little impact on the “standardized mortality ratio,” therefore they should not be held accountable for it.

“Here’s the damaging assumption in the study: The only way physicians or nurses improve patient survival is by avoiding killer mistakes. Surely clinical skill impacts mortality more than that,” Binder stated in her Modern Healthcare editorial.

Similarly, Binder pointed to a study published in the Journal of the American Medical Association (JAMA) that also minimized the impact of clinicians. The study compared how United States hospitals scored on CMS composite safety measures versus alternative measures the researchers invented based on process quality composites. She summarized the findings as stating, “Some hospitals excel on the invented quality composites but fail on the CMS safety composite. Illogically, the researchers conclude that the CMS safety composite is flawed. One might just as well conclude that the researchers’ composites are flawed.”

“Ultimately, this paints a dismal portrait of individual clinicians. … If you excel on some but not all measures, the measures are wrong and you don’t excel at anything,” she stated.

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group Advocates Transparency for Both Insurers and Patients

The Leapfrog Group was formed in 2000, a year after the Institute of Medicine’s (IOM’s) landmark report on medical errors, “To Err Is Human: Building a Safer Health System,” in which the IOM estimated that preventable medical errors caused 44,000 to 98,000 deaths annually, with an associated cost of $17 billion to $29 billion.

The watchdog organization operates out of Washington, D.C. and is made up of more than 170 of the nation’s largest purchasers of healthcare, including:



Lockheed Martin;

Marriot International;

University of Michigan; and

• the Florida Healthcare Coalition.

Through its annual hospital surveys and research, the non-profit urges insurers and patients to use transparency to improve the safety and quality of the healthcare system.

The Leapfrog Group’s movement for transparency has grown to include more than 1,700 hospitals that participate in its annual survey on safety, quality, and resource use. In 2015, a record 1,750 hospitals submitted a survey, representing 46% of hospitals nationwide. It also has focused attention on reducing early elective deliveries, launched a pay-for-performance program, and designed a Hospital Safety Score to help consumers to make better healthcare decision.

Providers Should Seek Transparency

While negotiations about quality measures have reached a fever pitch, Binder would like to see providers insist on transparency and accountability for their patients, a step she says would validate clinicians’ work and expertise.

“While thoughtful critiques of measures are important, politically-motivated denial of measures is destructive in unintended ways,” Binder stated in her editorial for Modern Healthcare. “It often follows the unfortunate pattern of these studies in assuming that providers perform at essentially the same level of quality and/or their actions can’t be linked to patient survival or healing,” she observed.

“If all physicians and nurses believed their work had such modest impact, the burnout problem might be even worse,” continued Binder. “People who choose a career in healthcare tend to be bright, competitive and caring, and they won’t last long if they believe their talents make virtually no difference.”

As noted above, since the Leapfrog Group represents many of the major purchasers of healthcare, Binder’s recent comments should grab the attention of pathologists and clinical laboratory executives. They would do well to anticipate continued calls for more quality and more measurement of quality in healthcare as the movement toward value-based reimbursement marches on. Contributing value to hospitals, physicians, and payers is quickly becoming the new paradigm for clinical laboratories and pathology groups.

—Andrea Downing Peck

Related Information:

Clinicians Must Push Back Against Critics Challenging the Role of Quality Measures

Standardized Mortality Ratios Should Not Be Used to Benchmark Hospitals, Study Concludes

Leapfrog Group Fact Sheet

Concerns About Using the Patient Safety Indicator-90 Composite in Pay-for-Performance Programs

To Err Is Human: Building a Better Health System

Leapfrog Study Shows Hospital Use of CPOE Can Affect Clinical Pathology Laboratory Test Utilization

Study Finds Weaknesses in the Performance Of CPOE System in Daily Care Settings

Many experts believe that wider use of computerized physician order entry (CPOE) systems can contribute to the better utilization of clinical pathology laboratory tests. CPOE is considered one method for helping the physician order the right medical laboratory test for the patient at the right time—then use the clinical lab test results to implement the most appropriate therapy.

CPOE is an important decision-support tool for physicians at the point-of-care (POC). Regular use of a CPOE is also something that the federal government specifically identified as necessary to accomplish “meaningful use” link under the ARRA/HITECH Act legislation. (more…)

National Standards Emerging for Patient ID in Hospitals

Use of colored wristbands is widespread in hospitals across the country. Different colors signify such things about a patient, such as allergies, a “do not resuscitate” order, and fall risk. But the widespread use of colored patient wristbands in hospitals has lacked uniformity across the country. Different hospitals use the same color to code for different things. This is often a problems when doctors and nurses work at more than one hospital where wrist band colors mean different things. In extreme cases, patients who did not have a “do not resuscitate” (DNR) order were mistaken as having a DNR based on their bracelet color. Confusion about the meaning of a colored wrist band has similarly contributed to problems when phlebotomists visit the patient to collect laboratory specimens.

To address the problems caused by colored wristbands, the Western Region Alliance of Patient Safety (WRAPS) was formed earlier this year, in January of 2007. This Arizona-based effort has grown to include hospital systems in seven states. The group has agreed on three colored wristbands: red for allergy alerts; yellow for fall risk patients; and purple for patients with a do not resuscitate order. “The wristbands don’t replace the medical record, but they are the first line of communication,” said Barb Avery, project director at the Arizona Hospital and Healthcare Association. WRAPS hopes that the standards it creates will be adopted nationally.

The development of a national body for the standardization of wristbands is probably not far off. Beyond assigning colors to conditions, research must be done on whether or not specific allergies should be printed on the bracelets, whether or not having patients wear DNR bracelets decreases the quality of their care, and other issues. The standardization of the colors of wristbands will help hospitals improve the quality of patient care and avoid costly lawsuits that may arise from errors made because of wristband color.

The laboratory community should take note of this latest development in standardization of patient care. Phlebotomists will find that bracelets may make it easier to verify patient identity before doing a blood draw. Soon, we can expect hospital wristbands to be standardized with the same precision as the order of draw is standardized by the National Committee for Clinical Laboratory Standards.

Finally, Dark Daily observes that this standardization of patient ID wrist band colors could have been accomplished decades ago, simply by agreement among the manufacturers of these products. It is no coincidence that the current patient safety movement is driving the standardization of many aspects of healthcare. When providers, such as hospitals and physicians, realize that their rate of medical errors is being measured and posted for the public to see, they become motivated to do better.

That is why laboratory managers and pathologists should expect to see a continual streak of such standardization and quality improvement projects across the hospital industry. Transparency in medical errors and improved patient outcomes is already having the effect desired by the nation’s major employers when they launched the Leapfrog Group and similar efforts to improve the performance of the American healthcare system.

Related Articles:

Hospitals Target Risks Of Color Wristbands

Banding Together for Patient Safety