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Medicare Officials Back Off a Proposal to Make Hospital Inspection Reports Publicly Available; CLIA Inspections of Medical Laboratories Are Still Not Public

The Joint Commission opposed the Medicare proposal, and patient advocate groups say rescinding it is a setback for hospital  transparency

Powerful interests arrayed against greater transparency in the performance of hospitals, physicians, and medical laboratories have stopped a proposed Medicare program that would have allowed the public to see the results of hospital inspections.

Stopped in its tracks was an effort by the Centers for Medicare and Medicaid Services (CMS) to make hospital accreditation inspection reports available for public viewing. Opposition to this program led CMS to withdraw its plan for heightened transparency.

CMS originally called the proposal “groundbreaking” in a National Public Radio (NPR) article. That’s because it would have enabled consumers to view reports that private accreditation organizations, such as The Joint Commission, complete after each inspection. Inspection reports contain information on errors and problems found during hospital surveys. CMS’ push for more transparency in hospital inspections is consistent with the healthcare industry’s trend toward open sharing of healthcare quality, price, and other data.

“We are proposing changes relating to transparency of accrediting organizations survey reports and plans of correction of providers and suppliers,” CMS officials wrote in a proposed rule published on April 28.

CMS Pulls Back Proposal to Make Hospital Survey Reports Public

But it was not to be. After receiving comments, CMS officials stated in early August that the agency had pulled back the proposal.

“CMS is committed to ensuring that patients have the ability to review the findings used to determine that a facility meets the health and safety standards required for Medicare participation. However, we believe further review, consideration, and refinement of this proposal is necessary to ensure that CMS establishes requirements, consistent with our statutory authority, that will inform patients and continue to support high quality care,” noted a CMS fact sheet.

Agencies Find Problems in Hospitals That Accreditors Do Not, CMS Declares

It’s against federal law for CMS to release data related to hospital inspections, Becker’s Hospital Review reported. And, as part of the Clinical Laboratory Improvement Amendments (CLIA), clinical laboratories must participate in inspections to ensure they qualify for Medicare and Medicaid payments. However, the inspection reports of the nation’s medical laboratories are not made public.

So, what motivated CMS to make healthcare organizations’ inspection information public? CMS noted that private accreditation organizations miss serious provider problems that state inspectors find in follow-up visits to hospitals, ProPublica explained.

In fact, state agency reviews of 103 hospitals in 2014 found 41 serious deficiencies, including 39 missed by the accreditors, noted the NPR article.

The chart above based on Johns Hopkins research was compiled by the National Center for Health Statistics and reported by The Washington Post. It shows that medical errors are now the third leading cause of death in the US. (Photo copyright: The Washington Post.)

“Right now, the public has very little information about the places where they’re putting their life on the line, and that’s just not acceptable. If [they are] a good place, what are they afraid of?” Rosemary Gibson, Senior Advisor at The Hastings Center, stated in the NPR article.

Reaction from Accreditors and Consumer Groups Differs

The Joint Commission opposed the CMS proposal. And, now, patient safety advocacy groups are disappointed about the decision by Medicare officials to rescind the proposed program.

“We believe the proposal will have significant detrimental consequences on our nation’s ability to continually improve the delivery of healthcare services,” stated Mark Chassin, MD, FACP, MPP, MPH, Joint Commission President and Chief Executive Officer, in a June letter to CMS published partially in an HCPro blog post.

HCPro, a firm that aids organizations in accreditation, credentialing, and other needs, noted the following Joint Commission concerns about publicly shared survey reports in the blog post:

  • Providers may be less likely to be open about opportunities for improvement;
  • Accreditors could struggle to create new standards;
  • The number of non-accredited facilities may increase;
  • Accreditation may be devalued; and,
  • Costs to providers and accreditors would likely rise.

The Center for Improvement in Healthcare Quality (CIHQ), another accreditation option for hospitals, also expressed concerns with the CMS proposal, according to the ProPublica report.

“Knowing that survey [inspection] reports are public knowledge will only incentivize hospitals and other healthcare entities to go back to the days of ‘hiding’ quality of care issues from accreditors, rather than working with us to improve the quality and safety of care rendered to patients,” CIHQ advised in the ProPublica article.

The Leapfrog Group, which bills itself as an advocate of hospital transparency, called the reversed proposal “a disappointing setback for healthcare transparency.”

In a statement, Leah Binder, President and Chief Executive Officer of The Leapfrog Group, noted, “We are disappointed to learn that the agency that runs Medicare (CMS) has reversed course on its proposal to require private accrediting organizations, such as the Joint Commission, to publicly release reports of problems they found in hospitals and other healthcare facilities. The public deserves full transparency on how the healthcare industry performs.”

Clearly the public is calling for increased transparency in healthcare. As are many organizations and industry journals, such as the Association of Health Care Journalists (AHCJ), which presented a national award to Ellen Gabler, an investigative reporter for the Milwaukee Journal Sentinel, for her work covering weaknesses in inspections for clinical laboratories. (See Dark Daily, “Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry,” May 16, 2016.)

Some Accreditation Information Available Online

So, for the time being, it appears that what is found during hospital inspections will stay within the inspection report and will not become available to the general public. However, with consumers expecting greater transparency and higher levels of service in all aspects of healthcare, the interest in public access to the quality performance of hospitals, physicians, clinical laboratories, and anatomic pathology groups will only increase.

Meanwhile, for patients interested in existing resources about provider quality, The Joint Commission has an online “find a gold star healthcare organization” quality check. Also, the American College of Surgeons publishes an online search for accredited facilities. And, the Centers for Disease Control and Prevention (CDC) offers an online search for CLIA accredited labs.

—Donna Marie Pocius

 

Related Information:

Secret Data on Hospital Inspections May Become Public At Last

Proposed Centers for Medicare and Medicaid (CMS) Rule

Changes to the Application and Reapplication Procedures for National Accrediting Organizations

CMS Backs Off Proposal to Make Hospital Accredited Investigations Public; Five Things to Know

Accreditors Can Keep Their Hospital Inspection Reports Secret, Feds Decide

Joint Commission Comments on Proposed CMS Transparency Rule

Disappointing Setback for Healthcare Transparency

Journalists Take Home Top National Awards for Their Work Covering Theranos and the Clinical Laboratory Industry

 

Collaboration between Pathologists, Medical Laboratories, and Hospital Staff Substantially Reduced Hospital-Acquired Infections, AHRQ Reports

Decline in hospital-acquired conditions (HACs) overall since 2010 attributed to increased attention to safety protocols and practices by hospital staff in cooperation with clinical laboratory services

It’s now been almost nine years since the Medicare Program stopped paying hospitals and other providers for certain hospital-acquired conditions (HACs). Included in this list are hospital-acquired infections (HAIs). The goal is to substantially reduce the number of HACs and HAIs, thus improving patient outcomes, while substantially reducing the healthcare costs associated with these conditions.

So, almost nine years into these programs, has there been progress on these goals? This is a question of key interest to Medical laboratories and pathology groups because they have a front-line role in working with clinicians to diagnose and treat HAIs, while also looking to identify the transmission of HAIs within the hospital.

A recent report by the Agency for Healthcare Research and Quality (AHRQ), a division of the US Department of Health and Human Service (HHS), indicates that there has been progress in the goal of reducing HACs. The AHRQ report noted a 21% decline in HACs between 2010 and 2015. Data collected during that time indicates a reduction of more than 3.1 million HACs and nearly 125,000 patient deaths due to HACs.

In 2015 alone, nearly one million fewer HAC incidents occurred. The reduction saved “approximately $28 billion in healthcare costs,” an outcome which, the AHRQ report notes, is the result of increased attention to safety protocols in hospitals and a “period of concerted effort by hospitals throughout the country to reduce adverse events.”

Clinical Pathologists/Laboratories Play Key Role in HAI Prevention

Though many reported incidents are associated with adverse drug events, HAIs have been significantly reduced in recent years due to focused efforts on infection prevention. The report notes that clinical pathologists have become vital players in infection prevention programs, and that increased coordination between hospital medical laboratories and clinicians played a crucial role in the reduction.

Eileen O’Rourke is an Infection Preventionist at the Lankenau Medical Center in Philadelphia. And she has served as a leader and consultant for hospital-based infection prevention programs in Pennsylvania since 1984. In an article on the Wolters Kluwer Pharmacy OneSource blog, O’Rourke noted that successful infection prevention and control requires development of “a highly visible and administratively supported infection prevention and control program with qualified and trained personnel.” Clinical pathologists are part of that support team, providing surveillance, testing, and interpretation of data essential for identifying epidemiological origins of infection and pathogen distribution. And the vital services that clinical laboratories provide to reduce HAIs center on surveillance, prevention, and control.

The chart above was calculated on US Dollars in 2012. Since then, thanks to contributions by medical laboratories and pathologists in collaboration with hospitals, those costs have decreased significantly. (Image copyright: MLive.com.)

In an article for Lab Testing Matters, John Daly MD, Chief Medical Officer at the Commission on Office Laboratory Accreditation, and former Director of Clinical Laboratories for the Duke University Health System, highlights the importance of surveillance. He states that it is “an essential element of an infection control program” providing “data to identify infected patients and determine the site of infection” as well as “factors that contributed to the infection.” Medical laboratories must, Daly stresses, provide “easy access to high-quality and timely data and give guidance and support on how to use its resources for epidemiologic purposes.”

Daly argues that medical laboratories function as liaisons to clinical services, working to “improve the quality of specimens sent to the laboratory and promoting appropriate use of cultures and other laboratory tests.” The laboratory should, according to Daly, be involved in all aspects of the infection control programs. This ensures:

  • Proper specimen collection;
  • Accurate and rapid testing; and
  • Accurate reporting of laboratory data.

Laboratory Data Provide ‘Early Warning’ for HAI Surveillance Systems

Robert A. Weinstein, MD, wrote in his 1978 article, “The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections,” that medical laboratories and pathologists are central to prevention and control of HAIs. Laboratory records, Weinstein remarked, serve as important data sources that can identify early spread of infection, thus becoming an “early warning system” for a potential outbreak of infections. The sampling that laboratories perform identifies not only the strain of infection, but the method by which infection is spread, and the best treatment options. Nearly 40 years later his statements ring truer than ever, as anatomic pathology laboratory data continues to reveal patterns of infection faster and more precisely than ever before.

Sarah Mahoney, PhD, is a research scientist at Navitor Pharmaceuticals in Cambridge, Mass. In an article published in the American Journal of Clinical Pathology, she states that in surveilling patterns of infection, pathologists also decipher the source of infection. Mahoney wrote that it is “necessary to identify the causative organism” for surveillance and management control of HAIs. She also noted that pathologists must strive to discriminate between “hospital- and community-acquired infection” in order to provide clinicians with guidance for treatment, and to map “infection transmission within a clinical setting.”

Hospitals Rely on Medical Laboratories and Pathologists to Help Reduce HAIs 

The concerted effort to reduce HACs and HAIs was inspired by incentives put forth by the US government. In 2008-2009, the Centers for Medicare and Medicaid Services (CMS) ceased paying for hospital-acquired conditions, including HAIs. Since that time, hospitals have worked to prevent and better manage HAIs. In the years since those incentives went into effect, hospitals have increasingly relied on medical laboratories and pathologists to provide necessary testing to prevent HAIs.

The CDC’s Antimicrobial Stewardship Programs create a further need for lab professionals to be involved in the identification, prevention, and treatment of HAIs. The core elements of the program state that the role of diagnostic laboratory testing—especially rapid diagnostic tests—is imperative in providing the necessary data needed to combat HAIs. The pressure is on for hospitals to reduce HAIs further to save lives and reduce costs. Thus, there is increased pressure on medical laboratories as well.

In an article in the College of American Pathologists’ online journal Cap Today,

Larry Massie, MD, Professor of Pathology at the University of New Mexico, and Chair of Pathology and Laboratory Medicine for the New Mexico VA Health Care System in Albuquerque, states that turn-around time is crucial for HAIs, but that laboratories often have difficulty keeping up with large volumes of samples. Massie suggests the use of new technologies could speed up turnaround time, particular for large healthcare providers.

The fight to reduce HAIs and HACs is showing significant progress, and clinical laboratories, working in tandem with clinicians and prevention programs, are a fundamental part of the success of HAI reduction. Clinical pathologists and laboratories often are the front line in prevention and management of HAIs, and the work they do in identifying infections is essential in the assessment and control of those infections.

Amanda Warren

  

Related Information:

National Scorecard on Rates of Hospital-Acquired Conditions 2010 to 2015: Interim Data from National Efforts to Make Health Care Safer

How Hospitals Can Reduce Hospital-Acquired Infections

HAI Data and Statistics

Hospital Acquired Infection: Molecular Study and Infection Control Guidelines

Rapid Sequencing and Characterization of Pathogens in Hospital-Acquired Infections

The Role of the Microbiology Laboratory in Surveillance and Control of Nosocomial Infections

Core Elements of Hospital Antibiotic Stewardship Program

Pressure’s on to Halt Nosocomial Infections

Hospital Acquired Infections

Surveillance of Hospital-acquired Infections: A Model for Settings with Resource Constraints

The Laboratory and Infection Control

Role of the Microbiologist in Infection Control and Hospital Epidemiology

Study Finds Occupying Hospital Bed Previously Used by Patient Receiving Antibiotics Increases Odds of Developing C.diff Infection

More People Using Ride-sharing Uber and Lyft to Get to Emergency Rooms for Medical Treatment; Might Medical Laboratories Use These Ride-sharing Services?

Clinical laboratories and pathology groups that use taxicabs to pick up patient specimens and bring them to the lab now have the option of using Uber and Lyft for this service

For decades, medical laboratories have used taxicabs to have specimens picked up from one location and driven to the lab for testing. This was a way to handle STAT specimens, for example. Now, with the rise in popularity of ride-sharing services such as Uber and Lyft, a burgeoning trend has emerged where people utilize ride-services rather than driving themselves to the emergency room (ER) for medical treatment. Should clinical laboratories use ride-sharing services as well for transporting specimens?

Cost and Choice Two Advantages of Ride-sharing Services

According to the Center for Disease Control and Prevention (CDC), there are 130.4 million visits to ERs each year in the US and approximately 15% of those patients arrive by ambulance. But ambulance rides and EMT services can be costly.

According to howmuchisit.org, a website where visitors can find out how much average consumers paid for products and services around America, a trip to the ER by ambulance can range from $350 to $2,000 or more, depending on location, distance to the ER, and the patient’s insurance company.

Conversely, the cost for the same transportation by Uber or Lyft would typically cost less than $100.

So, price is one advantage ride-sharing services have over traditional ambulance rides. There are others. Patients also can choose which hospital they will be taken to for treatment. This option is generally not available via ambulance. Additionally, passengers know what the price of the trip with Uber or Lyft will be up front. Months can pass before patients receive a bill for a traditional ambulance ride.

But is it a good idea to call up Uber or Lyft instead of dialing 911 in a potentially life-threatening situation when moments count and emergency medical technician (EMT) skills can save lives?

To Uber or Not to Uber? That Is the Question

There are no statistics on the number of people who use ride-sharing services to go to the ER. However, many drivers in a chat room for Uber drivers acknowledged an escalation in the amount of requests for trips to the ER, usually for maladies such as broken bones, bleeding wounds, vomiting, or allergic reactions.

In a STAT article, Francis Piekut, who drives for both Uber and Lyft in Boston, described what he encountered when taking a call to transport a passenger to the ER. “They were burned and wanted to go the emergency room,” he stated. “I don’t know how bad it was, but I knew they were in pain really bad.” He took the individual where they wanted to go, as he would any other fare.

“I didn’t mind it,” Piekut added. “I was already there, and I know the ambulance costs a lot.”

However, other drivers in the chat room indicated they had or would refuse such service requests due to:

  • Liability issues;
  • Fear of getting blood or vomit in their car;
  • Knowing that they could not speed through the streets like an ambulance during an emergency; and
  • Apprehension about being stuck with a dead body if the passenger perished on the way to the ER.

Officially, Uber and Lyft recommend that people call 911 in the event of an emergency. In an ABC News article, Uber stated: “We’re grateful our service has helped people get to where they’re going when they need it most. However, it’s important to note that Uber is not a substitute for law enforcement or medical professionals. In the event of any medical emergency, we encourage people to call 911.”

The screen shot above taken from an NBC News TODAY video shows that some Uber drivers feel they are not required or prepared to substitute for an actual ride in an ambulance or EMT van. Click on the link above to watch the full video report. (Photo copyright: NBC News TODAY.)

Nevertheless, some emergency departments are looking at ride-sharing services to reduce their workload. Officials in Washington DC are researching the use of such services for “non-emergency, low-acuity” calls. These types of calls were responsible for nearly half of the city’s 911 calls in 2015, STAT reported.

“In our research, we found that many of these calls did not require an ambulance,” Doug Buchanan, Chief Communications Officer for the District of Columbia Fire and Emergency Medical Services (DC FEMS), noted in the STAT article. He believes it would be beneficial if people with non-emergencies used ride-hailing services instead of an ambulance. “We would love our residents to take that initiative,” he stated.

Baltimore ER physician Mark Plaster, MD, believes there should be multiple transportation options available to patients to accommodate different types and intensities of injuries.

“I would hope that no one who needed truly urgent medical attention would take an Uber,” Plaster urged in the STAT article. “If you need medical care en route, a private car is a bad idea, because you won’t have the personnel or equipment to treat you.”

Nevertheless, Plaster can see some merit in using ride-sharing services to get to the ER.

“Rideshares don’t take ambulances out of service, and not everybody coming into the ER is in a dire situation,” he stated in the STAT article. “And the ambulance can be expensive.”

Clinical Laboratories Use Taxis to Transport Specimens

Ride-sharing services were originally established to improve on the cost and availability of taxicab services. Apparently, their faster service versus a traditional taxicab also makes them a desirable option for some individuals who need to get to an ER. But before you call Uber or Lyft to go to the ER, know that they are not prepared for true emergencies and your life could be on the line.

Clinical laboratories and pathology groups, on the other hand, have been using taxicabs for the delivery of lab specimens for decades. It is likely, then, that services like Uber and Lyft will soon be used for the transportation of lab test specimens, as well, and will continue to be utilized into the future.

—JP Schlingman

Related Information:

For a Trip to the ER, Some Are Opting for Uber over an Ambulance

Expert Warns: Take Ambulance Instead of Uber or Lyft to ER

Why Many People Are Turning to Uber over Ambulances in Emergencies

Why I Used Uber Instead of an Ambulance

Why some people are calling Uber instead of an ambulance to get to the ER

Uber to the ER?

$164 Per Mile: Surprise Ambulance Bills Are a Growing Problem and Difficult to Avoid

Lyft Plans to Expand to 100 More US Cities in 2017

Lyft vs. Uber: Just How Dominant Is Uber In the Ridesharing Business?

Point-of Care Urine Drug Test Kits Used by Rehabilitation Programs in Canada and US to Help Drug Users Detect the Presence of Fentanyl in Their Heroin and Opiate Drugs

A legal, supervised injection site (SIS) affiliated with Vancouver Coastal Health found 86% of drugs tested with strips contained fentanyl when tested with these medical lab test kits

Here’s an unexpected application of point-of-care testing (POCT) that may surprise pathologists and medical laboratory leaders. In a sort of “guerilla-warfare” street experiment that applies diagnostic technologies to a problem, the manager of a needle-exchange program in the Bronx has been helping heroin and other opioid users discover if a product they are about to ingest is contaminated by handing out test strips designed for testing urine.

The addicts participating in these special programs use the POCT urine test strips to test their drugs for the presence of fentanyl, a powerful synthetic opioid analgesic similar to morphine that can increase the potency of opioids to lethal levels. Rehab program directors adopted this approach to help prevent overdoses and deaths among drug users.

Reducing Overdoses with Test Strip Handouts

Opioids such as morphine are often prescribed to cancer or surgery patients to treat severe pain. However, according to a National Institute on Drug Abuse (NIDA) fact sheet, fentanyl is “50 to 100 times more potent than morphine.” When fentanyl is mixed with heroin or cocaine and sold on the streets, the potent mix can be deadly, NIDA explained.

Test strips ordered from Canada designed to check patients’ urine for fentanyl are being used by St. Ann’s Corner of Harm Reduction (St. Ann’s) in the Bronx, New York. The strips are being used to check drug users’ syringes for fentanyl, according to a National Public Radio Shots article. The idea is to inform drug users of what they have in hand and possibly encourage them to choose not to take the drug, use less, or slow things down, Shots reported.

“If you’re doing dope, we’ll give you a test strip so you can test and see if there’s fentanyl,” stated Van Asher, Data Manager at St. Ann’s, in the Shots article.

Whether an unlicensed individual distributing test strips to drug users violates state or federal regulations was not broached in the Shots article.

St. Ann’s gives out about 15 strips a day each costing $1, Shots noted. St. Ann’s staff is sharing data collected on the encounters with the Centers for Disease Control and Prevention (CDC) and with New York health departments.

Finding Fentanyl with Test Strips in Canada

St. Ann’s isn’t the first to use urine test strips for drug checking. Vancouver Coastal Health (VCH) in British Columbia, Canada, launched a pilot program for drug-checking in 2016 at its Insite facility.

Insite is a supervised injection site (SIS). It opened its doors in 2003 and operates under a constitutional exemption to Canada’s Controlled Drugs and Substances Act.

At Insite’s “supervised injection site” facility (above) in Vancouver, British Columbia, drug users can “legally” inject illegal drugs. Directors of this program have adapted point-of-care urine test kits typically used in medical laboratory testing to allow drug users to test their heroin and opiate drugs for the presence of fentanyl. The goal is to reduce overdoses and deaths from users unknowingly ingesting fentanyl. (Photo copyright: CBCNews.)

 

Insite began to test drugs for the presence of fentanyl in the fall of 2016. Data from 173 tests performed in July and August found that 86% of drugs tested contained fentanyl, noted a VCH news release.

“These initial results confirm our suspicion that the local drug supply is overwhelmingly contaminated with fentanyl. We’re hoping this information can help people who use drugs,” stated Mark Lysyshyn, MD, MPH, VCH Medical Health Officer and Professor of Medicine at University of British Columbia.

The test works when the client dilutes the substance with a few drops of water. A positive or negative result for fentanyl is revealed within seconds.

The test strip used by Insite was designed to check for fentanyl in urine, not for checking drugs, noted the VCH statement. Insite intends to review the pilot program test data and decide whether to continue testing services after the pilot program concludes.

Alexander Walley, MD, Director of the Addiction Medicine Fellowship Program and Assistant Professor of Medicine at Boston Medical Center, stated the test may aid users’ decision-making.

“Even when they know they’re going to be positive for fentanyl, the experience of somebody testing their drugs and seeing that it’s fentanyl has an impact. It really encourages them to use more safely,” he stated in the Shots article.

Overdose Deaths Due to Fentanyl in America

A CBC News, Manitoba, article called the death rate due to fentanyl ingestion a “Canada-wide disaster.” However, the problem is significant in the US as well.

Death rates from synthetic opioids, including fentanyl, rose more than 72% from 2014 to 2015 in the US, according to the CDC.

In New York City, fentanyl is increasingly being linked to overdoses. In 2016, nearly half (44%) of drug deaths involved drugs mixed with fentanyl. That’s a 16% increase over 2015, according to a NYC Health press release.

A report from the Tennessee Department of Health noted that 1,451 people died from drug overdose in 2015. That’s a state record. Deaths associated with fentanyl rose significantly from 69 in 2014 to 174 in 2015, the report noted.

How Fentanyl Works and Why It Is Dangerous

Here are some fentanyl facts from the NIDA:

  • Fentanyl works by binding to opioid receptors located in areas of the brain that control pain and emotions;
  • People may experience side effects such as euphoria, drowsiness, nausea, confusion, addiction, respiratory arrest, unconsciousness, coma, and death;
  • Increased risk of overdose exists when drug users are unaware a drug they are ingesting contains fentanyl.

Clinical laboratory directors and pathology groups nationwide might want to follow the progress of test strip services at St. Ann’s Corner and Insite’s SIS. This twist on traditional POCT—using urine test strips to look for the presence of fentanyl in substances—could aid their own communities achieve public awareness, change behaviors, and save lives.

—Donna Marie Pocius

Related Information:

An Experiment Helps Heroin Users Test Their Street Drugs for Fentanyl

86% of Drugs Checked at Insite Contain Fentanyl

Fentanyl Deaths Are a Canada-wide Disaster

5 New Supervised Injections Sites Coming to Fight Vancouver’s Fentanyl Overdose Crisis

1,451 Tennesseans Die from Drug Overdoses in 2015

State Data Confirms Overdose Deaths Primarily White Opioid Users

CMS Missed 96 Hospitals with Suspected HAI Reporting Due to Limited Use of Analytics, OIG Report Reveals

OIG suggests better use of analytics by CMS could prevent gaming of the system by providers; clinical laboratories can help through test utilization management technology

It may come as a surprise to many hospital-based pathologists and clinical laboratory managers that the Centers for Medicare and Medicaid Services (CMS) has reason to suspect that some hospitals are “gaming” the system in how they report hospital-acquired infections (HAIs).

In 2015, CMS implemented the Hospital-Acquired Condition Reduction Program (HACRP) as part of the Patient Protection and Affordable Care Act (ACA). The HACRP program incentivizes hospitals to lower their HAI rates by adjusting reimbursements according to the inpatient quality reporting (hospital IQR) data provided by the healthcare providers. Hospital IQR data is the basis on which CMS validates a hospital’s HAI rate (among other things CMS is tracking) to determine the hospital’s reimbursement rate for that year.

However, an April 2017 report by the Office of the Inspector General US Department of Health and Human Services (OIG) noted that CMS was not doing enough to identify and target hospitals with abnormal reporting of HAIs.

The OIG reported:

  • CMS, in 2016, met its regulatory requirement to validate inpatient quality reporting data;
  • It reviewed data of 400 randomly selected hospitals as well as 49 hospitals targeted for failing to report half their HAIs, or for low scores in the prior year’s validation process;

However, OIG also reported that CMS did not include hospitals that displayed abnormal data patterns in its targeted sample. Targeting those hospitals, according to the OIG, could identify inaccurate reporting.

CMS staff had identified 96 hospitals with aberrant data patterns, but did not target them for validation—even though the agency can select up to 200 targeted hospitals for review, Becker’s Hospital Review pointed out.

Dollars More Important than Deaths

According to the OIG report, Medicare excluded in its investigation dozens of hospitals with suspected HAI reporting. This is odd since the CMS and the Centers for Disease Control (CDC) apparently are aware that some healthcare providers have manipulated data to improve their quality measure scores and thus increase their reimbursement rates.

“Collecting and analyzing quality data is increasingly central to Medicare programs that link payments to quality and value. Therefore, it is important for CMS to ensure that hospitals are not gaming [manipulating data to improve scores] their reporting of quality data,” the OIG report noted.

“There are greater requirements for what a company says about a washing machine’s performance than there is for a hospital on quality of care. And this needs to change,” stated Peter Pronovost, MD, PhD, in the Kaiser Health News article. “We require auditing of financial data, but we don’t require auditing of healthcare quality data, and that implies that dollars are more important than deaths.” Pronovost is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine.

 

Peter Pronovost, MD, PhD

Peter Pronovost, MD, PhD (above) testifying on preventable deaths before the Senate Subcommittee on Primary Health and Aging in 2014. He is Senior Vice President for Patient Safety and Quality at Johns Hopkins University School of Medicine in Baltimore. Pronovost told Kaiser Health News that there are no uniform standards for reviewing data that hospitals report to Medicare. (Photo copyright: US Senate Committee on Health, Education, Labor and Pensions.)

Medicare Missed Hospitals with Suspected HAI Data

CMS should have done an in-depth review of many hospitals that submitted “aberrant data patterns” in 2013 and 2014, the OIG stated in its report. According to a Kaiser Health News article, such patterns could include:

  • A rapid change in results;
  • Improbably low infection rates; and
  • Assertions that infections nearly always struck before patients arrived at the hospital.

“There’s a certain amount of blind faith that hospitals are going to tell the truth. It’s a bit much to expect that if they had a bad record they are going to fess up to it,” noted Lisa McGiffert, Director of the Safe Patient Project at Consumers Union, in the Kaiser Health News article.

CMS Needs Better Data Analytics

So, what does the OIG advise CMS to do? The agency called for “better use of analytics to ensure the integrity of hospital-reported quality data.” Specifically, OIG suggested CMS:

  • Identify hospitals with abnormal percentages of patients who had infections on admission;
  • Apply risk scores to identify hospitals with high propensity to manipulate reporting;
  • Use experiences to create and improve models that identify hospitals most likely to game their reporting.

CMS’ Administrator Seema Verma reportedly responded, “We will continue to evaluate the use of better analytics as feasible, based on Medicare’s operational capabilities.”

Medical Laboratory Diagnostic Testing Part of Gaming the System

A 2015 CMS/CDC joint statement noted “three ways that hospitals may be deviating from CDC’s definitions for reportable HAIs,” and two involve diagnostic test ordering. According to the OIG report, they include:

  • Overculturing: Diagnostic tests may be overutilized by providers in absence of clinical symptoms. Hospitals may use positive results to game their data by claiming infections that appeared days later were present on admission and thus not reportable.
  • Underculturing: Hospitals underculture when they do not order diagnostic tests in the presence of clinical symptoms. By not ordering the test, the hospital does not learn whether the patient truly has an infection and, therefore, the hospital does not have to report it.
  • Adjudication: Hospital administrative staff may inappropriately overrule those who report infections. HAIs are, therefore, not shared.

Clinical Laboratories Can Help

One in 25 people each day receives an HAI, CDC estimates. The OIG findings should be a reminder to medical laboratories and pathology groups that quality measures and patient outcomes are often transparent to media, patients, and the public.

One way medical laboratories in hospitals and health systems can help is by investing in utilization management technology and protocols that ensure appropriate lab test utilization. Informing doctors on the availability of appropriate diagnostic tests based on patients’ existing conditions, unique physiologies, or medical histories, could help prevent hospitals from inadvertently or deliberately game the system.

Clearly, transparency in healthcare is increasing. That means there will be more news stories revealing federal agencies’ failures to respond to healthcare data in ways that could have protected patients and the public. Clinical laboratories don’t want to be included in negative reporting.

—Donna Marie Pocius

Related Content:

CMS Validated Hospital Inpatient Quality Reporting Program Data, But Should Use Additional Tools to Identify Gaming

Medicare Failed to Investigate Suspicious Infection Cases from 96 Hospitals

CMS Can Do More to Validate Hospital-Reported Infection Data, OIG Report Finds

Study Suggests Medical Errors Now Third Leading Cause of Death in the US

Research Study at Johns Hopkins University Reveals CDC Does Not Record Medical Errors in Annual Mortality Report, Yet Such Errors Are Third Leading Cause of Death

Biggest Opportunity for Clinical Laboratory Industry is Utilization Management of Lab Tests, But Only If It Is Done Well

Lessons from the Pioneers: Reporting Healthcare-Associated Infections

Webinar: Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value 

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