PCORI Issues Draft Methodology Report on Patient-Centered Outcomes Research for Public Comment

On July 23, 2012, The Patient-Centered Outcomes Research Institute released for public comment through September 14, 2012 a draft report proposing 60 standards for the conduct of patient-centered outcomes research.

The report was developed by PCORI’s 17-member Methodology Committee, which will present a revised report to the PCORI Board of Governors for consideration in November. “We believe that methods matter – that patients deserve research results that meet the highest scientific standards,” said Committee Chair Sherine Gabriel, M.D., professor of medicine and epidemiology at the Mayo Clinic. “We now need the input of all health care stakeholders to ensure that their perspective is reflected in this resource.”

The PCORI Draft Methodology Report, “Our Questions, Our Decisions: Standards for Patient-Centered Outcomes Research,” is available at this link.

General comments and comments about specific chapters in the draft report can be submitted here.

Public comments submitted by other patients and stakeholders are available for viewing at this link.

Credit: AHA

Hospitals Rarely Report Adverse Events, Says OIG

Hospitals rarely inform state health departments about adverse events that cause temporary or serious harm to patients, often because states don’t require that they be reported, but also because treatment teams don’t identify such events, according to an Office of Inspector General (OIG) “Memorandum Report”

The report finds that 60% of adverse and temporary events nationally occurred at hospitals in states with reporting systems. But only 12% of the events met state requirements for reporting. And hospitals reported only 1% of the events.

The complete article is available on the HealthLeaders Media website at this link.

The OIG “Memorandum Report” (OEI-06-09-00092) is available on the HHS website at this link.

Researchers Investigate Improper High-Level Disinfection Practices During Endoscopy Procedures

Objective, Design, & Setting

In a retrospective cohort study conducted in four Veterans Affairs medical centers (VAMCs), Holodniy M, et al. (2012) sought to determine whether improper high-level disinfection practices during endoscopy procedures resulted in bloodborne viral infection transmission among veterans who underwent colonoscopy and laryngoscopy (ENT) procedures from 2003 to 2009.


Patients were identified through electronic health record searches and serotested for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV). Newly discovered case patients were linked to a potential source with known identical infection, whose procedure occurred no more than 1 day prior to the case patient’s procedure. Viral genetic testing was performed for case/proximate pairs to determine relatedness.


The researchers report that of 10,737 veterans who underwent endoscopy at four VAMCs, 9,879 patients agreed to viral testing. Of these, 90 patients were newly diagnosed with one or more viral bloodborne pathogens (BBPs). There were no case/proximate pairings found for patients with either HIV or HBV; 24 HCV case/proximate pairings were found, of which seven case patients and eight proximate patients had sufficient viral load for further genetic testing. Only two of these cases, both of whom underwent laryngoscopy, and their four proximates agreed to further testing. None of the four remaining proximate patients who underwent colonoscopy agreed to further testing. Mean genetic distance between the two case patients and 4 proximate patients ranged from 13.5 % to 19.1 %.


The investigators concluded that exposure to improperly reprocessed ENT endoscopes did not result in viral transmission in those patients who had viral genetic analysis performed. Any potential transmission of BBPs from colonoscopy remains unknown.

The complete study is available in free full text in Infection Control and Hospital Epidemiology at this link.

Joint Commission Updates Sentinel Event Statistics Through Q1 2012

The Joint Commission has updated its Sentinel Event statistics through March 31, 2012 and published four related presentations, including general information on Sentinel Event data, root causes by event type, event type by year, and a summary of Sentinel Event data.

Since the Joint Commission implemented its Sentinel Event database in January 1995, the organization, through Q1 2012, has reviewed a total of 8,859 Sentinel Events, and issued 48 Sentinel Event Alerts. The latest Sentinel Event Alert, focusing on health care worker fatigue and its potential effect on patient safety, was issued in December 2011.

The Joint Commission has determined that Sentinel Events reviewed since 2004 have resulted in 3,859 patient deaths and impacted 6,383 patients, including unanticipated additional care, extended care, and psychological Impact.

Sentinel Events are divided into 27 specific categories, with a 28th category that includes the remaining ‘other unanticipated event[s].’ In Q1 2012, The Joint Commission reviewed 225 Sentinel Events, with the most reviewed event being ‘Unintended Retention of a Foreign Body’ (42), followed by ‘Delay in Treatment’ (33), then ‘Wrong-Site, Wrong-Patient, Wrong-Procedure’ events(27).

In 2011, ‘Perinatal Death or Injury,’ the ninth most reviewed event in 2010, and the tenth most reviewed event in 2009, was removed from the top ten most reviewed Sentinel Event list, and replaced at number ten by ‘Medical Equipment-Related’ events. ‘Medical Equipment-Related’ events had been the eleventh most reviewed Sentinel Event in 2010. In Q1 2012, there were six ‘Perinatal Death or Injury’ events and two ‘Medical Equipment-Related’ events reviewed.

Sentinel Event Data Summary (as of March 31, 2012)


“This sentinel event-related data, reported to The Joint Commission from our accredited organizations, demonstrates the need of the Joint Commission and accredited health care organizations to continue to address these serious adverse events. This data also supports the importance of establishing National Patient Safety Goals and focusing our energies on addressing serious errors within health care organizations. By identifying causes, trends, settings and outcomes of sentinel events, The Joint Commission can provide critical information in the prevention of sentinel events to accredited health care organizations and the public.”

[The Sentinel Event Data Summary] Includes:

  • Type of Sentinel Event
  • Settings of Sentinel Events
  • Sources for SE Identification 
  • Sentinel Event Outcomes
  • Self-reported Sentinel Events by Year
  • Method for Review of HCO Response to Sentinel Event 

Sentinel Event Data – General Information (1995 – Q1 2012)

“The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events.Therefore, these data are not an epidemiologic data set and no conclusions should be drawn about the actual relative frequency of events or trends in events over time.”

Sentinel Event Data – Event Type By Year (1995 – Q1 2012)


Sentinel Event Data – Root Causes By Event Type (2004 – Q1 2012)


NIOSH Updates List of Antineoplastic and Other Hazardous Drugs for 2012

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its guidance document, the “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings,” for 2012.

Originally published as part of a September 2004 NIOSH Alert, “Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings,” the list was later updated in 2010. For the 2012 update, NIOSH reviewed approximately 70 new drugs that received approval from the U.S. Food and Drug Administration (FDA) and approximately 180 drugs that received new special warnings, usually black box warning, based on reported adverse effects in patients from October 2007 to December 2009.

From this list of approximately 250 drugs, NIOSH identified 26 drugs as having one or more hazardous characteristics and, after expert panel review, public review and comment, and a review of the scientific literature, NIOSH decided to include all 26 of these drugs in the updated 2012 list. In addition, NIOSH removed 15 drugs from the 2012 list because they did not meet the NIOSH definition, were no longer available in the United States, or were regulated by other government entities.

The Notice of Draft Document Available for Public Comment (NIOSH-190) was published in the August 2, 2011 Federal Register, and is available at this link. The Notice of Issuance of Final Guidance Publication (NIOSH-033-A) was published in the June 27, 2012 Federal Register, and is available at this link.

The “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012” is available through the CDC website at this link.

Joint Commission “Comprehensive Stroke Center Certification” Webinar Now Online, Free Access

For those who was unable to join the July 17, 2012 Joint Commission ‘Comprehensive Stroke Center Certification’ webinar, both the recorded webinar and the webinar slides are now available for viewing free of charge.

The objectives of the ‘Comprehensive Stroke Center Certification’ webinar are to:

  • Present a revision to the CSC eligibility criteria and DSPM 1, EP 2, c & d regarding the volume needed for clipping and coiling procedures for aneurysm.
  • Clarify The Joint Commission’s position on the meaning of “available 24/7” for staff and licensed independent practitioners.
  • Answer additional questions received recently regarding CSC certification requirements.

The recorded ‘Comprehensive Stroke Center Certification’ webinar is available at this link. The webinar slides are available here.

More information about Comprehensive Stroke Center Certification is available on The Joint Commission website at this link.

HHS Revises Dates for Regional Forums on Affordable Care Act Implementation

The U.S. Department of Health and Human Services (HHS) has revised the schedule for its four regional forums to address questions and concerns from state officials and other stakeholders as the department moves forward in implementing the Patient Protection and Affordable Care Act (ACA).

In a July 10, 2012 letter to governors, Health and Human Services Secretary Kathleen Sebelius announced four regional forums and stated that HHS is “committed to providing states with as much flexibility as we can to achieve successful implementation of the many important opportunities provided by this legislation.”

The letter also stated that “The Supreme Court held that, if a state chooses not to participate in [the ACA’s] expansion of Medicaid eligibility for low-income adults, the state may not, as a consequence, lose federal funding for its existing Medicaid program,” and that “the Court’s decision did not affect other provisions of the law.”

The forums are now scheduled for August 14, 2012 in Washington, D.C.; August 15, 2012 in Atlanta; August 21, 2012 in Chicago; and August 22, 2012 in Denver. Interested parties can register to attend one of the forums at this link.

ACA Section 1104: New Technology Operating Rules for Physician Practices

Perhaps you’re busy wondering what your state will do about the Patient Protection and Affordable Care Act’s (ACA) Medicaid provision, and the impact that’ll have on your practice. Or you’re celebrating (lamenting?) the insurance mandate, which remains intact after the Supreme Court cast its 5-4 vote in favor of the healthcare law.

But you probably haven’t thought about one of the little-noticed aspects of the law that deals with technology and could have a big effect on your practice: Section 1104.

Section 1104 of the ACA “…establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs.” Specifically, ACA Section 1104 requires the secretary of HHS to adopt and regularly update standards, implementation specifications, and operating rules for the electronic exchange and use of health information for the purposes of financial and administrative transactions.

ACA Section 1104 applies to all HIPAA-covered entities and business associates engaging in electronic standard transactions. Legislation requires that the standards and operating rules adopted by HHS will:

  • Allow for the determination of an individual’s eligibility and financial responsibility for specific services prior to or at the point of care;
  • provide for timely acknowledgment, response, and status reporting that supports a transparent claims and denial management process (including adjudication and appeals); and
  • describe all data elements (including reason and remark codes) in unambiguous terms, require that such data elements be required or conditioned upon set values in other fields, and prohibit additional conditions (except where necessary to implement State or Federal law, or to protect against fraud and abuse).

What Section 1104 of the ACA means for your practice…

The complete article is available on the PhysiciansPractice website at this link. [Note: Free registration is required to view the article.]

To learn more about Patient Protection and Affordable Care Act’s (ACA) Medicaid provision, read “How the Medicaid Provision Will Affect Physician Practices,” also available on the PhysicianPractice website at this link. [Note: Free registration is required to view the article.]

To learn more about ACA Section 1104 Requirements, read “ACA Federal Mandate for Healthcare Operating Rules” on the CAQH website at this link.

New AHRQ Handbook Helps Practices Implement Interactive Preventive Health Records

A new handbook from the Agency for Healthcare Research and Quality (AHRQ) offers practical guidance on the implementation of interactive preventive health records (IPHRs). Based on the lessons learned from implementation using EHRs from 3 different vendors at 14 different practices, An Interactive Preventive Care Record: A Handbook for Using Patient-Centered Personal Health Records to Promote Prevention provides practical steps for healthcare professionals to follow when integrating IPHRs as components of electronic health records.

In an article, Randomized Trial of an Interactive Preventive Health Record to Enhance the Delivery of Recommended Care, published in the Annals of Family Medicine, the authors found that IPHR users were more likely to be up-to-date on all preventive services compared with nonusers, especially in the areas of screening tests and immunizations. The study findings showed that an IPHR and similar systems can improve important patient outcomes, such as the delivery of evidence-based preventive care. Researchers recommend that attention is needed to ensure future personal health records can deliver higher levels of functionality, similar to the IPHR, and that a greater number of patients and clinicians actively use the systems.

The IPHR was developed and studied in three AHRQ-funded projects to better understand how to broadly implement and disseminate patient-centered information systems throughout primary care.   These three projects build upon one another to show the development and effect of the IPHR tool on patient outcomes, the ability for it to be successfully adopted into multiple and varied EHRs and health care settings, and how it can be integrated into the primary care workflow for an entire practice’s patient population.

An Interactive Preventive Care Record: A Handbook for Using Patient-Centered Personal Health Records to Promote Prevention is available for free download on the AHRQ website at this link.

The Annals of Family Medicine article “Randomized Trial of an Interactive Preventive Health Record to Enhance the Delivery of Recommended Care” is available in free full text at this link.

More information about AHRQ’s IPHR projects are available at this link.

NAQC Issues 9 ‘Guiding Principles’ for Healthcare Providers to Engage Patients in Care

On July 12, 2012, The Nursing Alliance for Quality Care (NAQC) issued a list of guiding principles to help nurses and other health care providers engage patients in their care. The nine “Guiding Principles for Patient Engagement” call for a dynamic partnership among patients, their families, and caregivers that includes mutual responsibilities and accountabilities and shared decision-making.

“We hope that nursing organizations, nursing programs, medical schools, and others will use these principles to inform their members and students and integrate patient engagement into their programs and practices,” said Pamela Thompson, CEO of the AHA’s American Organization of Nurse Executives subsidiary and chair of the subcommittee that drafted the principles.

NAQC plans to discuss how to implement the principles with leading nursing organizations, patient advocates, and other provider groups, and to host a conference on the topic in November.

The NAQC “Guiding Principles of Patient Engagement” are available on the George Washington University Medical Center website at this link. The press release is available here.