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Clinical Laboratories and Pathology Groups

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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

 

Evolution and Revolution in Anatomic Pathology Discussed by Experts at Cold Springs Harbor Laboratory This Week

Because of ongoing advances in gene sequencing and the data analytics needed to interpret that information, new approaches to clinical care are becoming available to physicians and pathologists

COLD SPRING HARBOR, NEW YORK—Internationally-recognized as a leader in bringing together the brightest minds in genetics, the Banbury Center at the Cold Spring Harbor Laboratory (CSHL) produced a three-day conference here last week to explore the future state of anatomic pathology and identify opportunities in genetic medicine and image sciences that play to the strengths of the nation’s pathology laboratories.

“Evolution and Revolution in Anatomic Pathology: Automation, Machine-Assisted Diagnostics, Molecular Prognostics, and Theranostics” was the title, and the meeting’s organizers were CSHL and the Department of Pathology and Laboratory Medicine at Northwell Health.

Cold Spring Harbor Laboratory Founded in 1890

The Cold Spring Harbor Laboratory has a long history and an enviable reputation. It was founded in 1890 to train teachers in biology. However, by 1904, the laboratory’s mission had been expanded to include research in genetics. In 1924, the research mission was further enlarged to include quantitative biology—in particular, physiology and biophysics.

It was in 1968 that Nobel laureate James Watson, then a professor at Harvard University, accepted the directorship of the Cold Spring Harbor Laboratory while also keeping his professorship at Harvard University. Watson served at some level of leadership until 2008, when he became Chancellor Emeritus. Currently CSHL laboratory houses about 200 research-related personnel. (more…)

Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (more…)

Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market

Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.

One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.

Announced in a May 2016 statement,  the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).

Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)

World’s Two Largest Whole Genome Sequencing Programs Give Pathologists and Clinical Laboratory Managers an Intriguing Look at New Diagnostic Opportunities

At Human Longevity, Inc. and the United Kingdom’s 100,000 Genome Project, knowledge gained from whole-genome sequencing is starting to be used to improve patient care

NEW ORLEANS, LAWhole-human gene sequencing is poised to provide significant contributions to improving clinical care. That was one conclusion from expert speakers at the 21st annual Executive War College on Medical Laboratory and Pathology Management that happened here this week.

How fast knowledge from whole-human gene sequencing finds its way into clinical diagnostics and healthcare can be debated. But what is unquestioned, based on these presentations, is that insights gained from the analysis of large numbers of human genomes will trigger a revolution in how pathologists and physicians diagnose, treat, and care for patients. (more…)

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