March 4, 2008

RedLine
 

Steps to Becoming a Patient Safety Organization

Creating an infrastructure that allows for the capture of information on medical errors, yet protects the confidentiality of that data, the patient and provider, is the subject of a new proposed regulation on Patient Safety and Quality Improvement.   The proposed rule, issued on February 12, 2008, suggests how organizations may become a Patient Safety Organization (PSO) and outlines confidentiality protections and penalties. 

Defining Words

The proposed rule explains the use of several terms that will be used within the PSO context.  Among them:

Patient Safety Activities are conducted by or on behalf of a PSO.  Efforts to improve patient safety and the quality of health care delivery; collection and analysis of patient safety work product; development and dissemination of information with respect to improving patient safety (e.g., recommendations, protocols); utilization of patient safety work product to encourage a culture of safety and minimize risk; providing appropriate security measures and utilizing qualified staff; and operating a patient safety evaluation system are all within the realm of patient safety activities.

Patient Safety Evaluation System is the collection, management or analysis of information use for reporting to/from a PSO.

Patient Safety Work Product includes data, reports, records and analyses that are created by a health provider for reporting to a PSO or to a patient safety evaluation system.  The Patient Safety Work Product does not include a patient’s medical record, billing or discharge details, or information maintained separately from a patient safety evaluation system.  Information that is not considered Patient Safety Work Product may be admitted in a criminal, civil or administrative proceeding and may be reported to governmental agencies for public health purposes.

Who May Become a PSO?

Private or public organizations, or components of such entities, may be considered a patient safety organization (PSO) if listed by the Secretary of Health and Human Services.   Issuers of health insurance – or components of a health insurance organization – are not eligible to become a PSO.  Also, any public or private group that conducts regulatory oversight of health care providers, such as accreditation or licensure agencies, may seek status as a PSO, but a component of such organizations may be eligible as a component PSO.

It is important to recognize that PSOs will not be federally funded.

How to Be Listed as a PSO

Eligible organizations must submit a completed certification form to the Secretary of Health and Human Services in order to be considered for listing as a PSO.  The Secretary has the discretion to accept, deny or apply conditions to the PSO listing.  Generally, accepted PSOs will be listed for three years.  After this period, a PSO must file to continue the certification.   The Secretary may conduct announced or unannounced inspections of PSOs to verify compliance with all requirements.

Certification Requirements

To be certified as a PSO, the proposed rule outlines 15 general requirements that must be met, including:

• Written, established policy and procedures to perform eight patient safety activities and meet confidentiality and security measures
• Primary mission must be to conduct activities to improve patient safety and the quality of health care delivery
• Employ appropriately qualified workforce
• Enter into bona fide contractual relationships, within a specified time period, with two different providers for the purpose of receiving and reviewing patient safety work products
• Certify that the PSO is not a health insurance issuer
• Make required disclosures to the Secretary of HHS
• Collect patient safety work products from providers in a standardized manner to allow for valid comparisons
• Provide direct feedback and assistance to health care providers for the purpose of minimizing patient risk

PSOs considered “components” must meet additional requirements to ensure separation from parent organizations.

Security

Security of the patient safety work product is of paramount interest.  PSOs must develop a framework for security that includes security management, separation of systems, security monitoring and control, and system assessment.  Appropriate security standards, policies and procedures must be developed and implemented.

Liability Protections

Patient safety work product is considered privileged and is, therefore, not subject to civil, criminal or administrative subpoena or order in federal, state, local or tribal court.  Also, the patient safety work product may not be admitted as evidence or subject to discovery or disclosure, and may not be used in administrative disciplinary proceedings against a provider.  Exceptions are made for the disclosure of relevant patient safety work product in certain criminal proceedings, non-identifiable information and for certain provider authorizations. 

Next Steps

In the development of these new entities known as PSOs, the proposed rule seeks specific advice from the public through a series of 47 questions. For additional information on the proposed rule, how to comment on the proposal, or how your organization might comply, please contact Auburn Health Strategies.

Congress Examines Need for Nurses, Dentists and Physicians

According to an extensive hearing by the Senate Committee on Health, Education, Labor and Pensions and a report by the Government Accountability Office (GAO), there is a concern that the supply of primary care services does not and will not meet the needs of the nation. 

A. Bruce Steinwald, MBA, Director for Health Care at the GAO, testified that disparities in income between primary care physicians and specialty physicians are part of the reason for the supply concerns.  Yet, the GAO reported, “accurately projecting the future supply of primary care health professionals is difficult, particularly over long time horizons…”   The report noted that, in recent years, “the supply of primary care professionals increased with the supply of non-physicians increasing faster than physicians.”  Information for the GAO report was derived largely from literature searches and interviews with health care association officials.  GAO surmised, “health professional workforce projections that are mostly silent on the future supply of and demand for primary care services are symptomatic of an ongoing decline in the nation’s financial support for primary care medicine.”  The GAO report argued for a recalibration of the value of all health care services for primary and specialty care.

Senator Lisa Murkowski (R-AK), in her opening remarks at the Senate hearing on February 12, 2008, noted that 62 million Americans – approximately 20 percent of the country’s population – live in medically underserved areas, yet only nine percent of the nation’s physicians work in those areas.  She noted that Alaska is desperate for primary care physicians.  Senator Murkowski introduced the Physician Shortage Elimination Act of 2007, S. 896, which would reauthorize the National Health Service Corps Scholarship and Loan Repayment Program, expand medical residency training programs at community health centers, and provide grants to improve the delivery of primary care services.  Senators Charles Schumer (D-NY), Ted Stevens (R-AK), and Bernard Sanders (I-VT) cosponsor the legislation. 

Among the solutions, hearing witnesses and many Senators urged the reauthorization and funding of Title VII and Title VIII to support the health profession programs. 

FDA Guidance for Flu Diagnostics

In the midst of an active flu season, the Food and Drug Administration has made recommendations intended to assist with the diagnosis or detection of influenza infection.  In a draft guidance document, the agency suggests to manufacturers of in vitro diagnostic (IVD) devices studies that may assist in establishing analytical and clinical performance of devices that detect or diagnose the flu.

The draft document outlines the FDA’s current thinking on the performance characteristics of devices that detect influenza viral antigens or viral genomes.  It does not prescribe specific regulatory requirements. 

Key points to highlight

This guidance is limited to studies aiming to establish the performance characteristics of devices that detect influenza viral antigens or influenza viral genome (protein or nucleic acid).

Rapid detection devices are included.

Public health, morbidity and mortality, and inaccurate patient management concerns surface if influenza virus detection devices fail.  Effectiveness and safety of the devices is important.

Appropriate external controls should be performed daily for the duration of the analytical and clinical studies. 

Studies to perform:  Analytical sensitivity for known Influenza A and B strains; Analytical sensitivity (cross-reactivity, interference); Precision (within laboratory precision, reproducibility); Specimen storage and shipping conditions; and Clinical performance studies (including study protocol, specimen type(s), study sites and populations, reference methods comparison).

Waiver for the device under the Clinical Laboratory Improvement Amendments may be sought.

Additional, yet complementary, suggestions made for nucleic acid-based influenza devices.

For a copy of the draft guidance, contact Auburn Health Strategies at solutions@auburnstrat.com.