Safety issues as exemplified by the activities of the Joint Commission on Accreditation of Healthcare Organizations: context for the safety and disclosure standards

The author, the General Counsel of the joint Commission on Accreditation of Healthcare Organizations, discusses the concerns that have been raised about the Commission's Patient Safety standards and Sentinel Event policy. Mr. Bressler understands the view that compliance with the Commission's standards and procedures (which are designed to help advance safety in our healthcare system) could, in particular cases and under certain circumstances, heighten litigation risks, but emphasizes the benefits attainable from systematic analysis of errors. Moreover, the article concludes that thoughtful lawyering by counsel for healthcare organizations can help minimize any risks, pending legislation establishing the needed certainty in the law.     

Medicare and Medicaid programs; recognition of the Joint Commission on Accreditation of Healthcare Organizations standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. As a result of this recognition, HHAs accredited by JCAHO are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which JCAHO must comply to maintain Medicare and Medicaid recognition of its HHA accreditation program.     

Approval of the Commission on Office Laboratory Accreditation for Immunohematology--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA), which is an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments (CLIA) program, for the addition of the full specialty of immunohematology. This approval adds immunohematology to the specialties and subspecialties approved by HCFA in a notice published in the Federal Register on December 23, 1993 (58 FR 68148). We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it for immunohematology meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA for the specialty of immunohematology in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA immunohematology condition level requirements for laboratories. These laboratories performing immunohematology testing are not subject to routine inspection by State survey agencies to determine their compliance with applicable Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Accreditation and the state of North Carolina: The revitalization of national standards

From the mid to late 70s, the Academy of Criminal Justice Sciences (ACJS) developed a process for accrediting post-secondary criminal justice education programs. The academy gave form to the program by developing guidelines and a complex organizational network. However, the program did not reach fruition for a variety of economic and political reasons and it is doubtful that the Academy will attempt to resurrect the program soon. Even though the accreditation movement was abandoned on the national level, the North Carolina Association of Criminal Justice Educators (NCACJE) decided to implement the program and stepped into a very lengthy and political process.     

Creating problems as part of the "solution": the JCAHO Sentinel Event Policy, legal issues, and patient safety

The recently reported number of patient deaths attributable to medical errors is staggering. In response to this crisis, the Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") proposed its Sentinel Event Policy. The policy mandates self-reporting by hospitals accredited by the JCAHO. This Article argues that the JCAHO's policy shows an inattention to the legal realities of discovery and absence of immunity. Until the JCAHO addresses these issues, self-reporting will have limited success. This Article suggests that to promote patient safety, self-regulatory reports should go to a neutral, nonsanctioning third party, an approach adopted from aviation's highly successful reporting system.     

Medicare program; recognition of the Community Health Accreditation Program standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Community Health Accreditation Program (CHAP), a subsidiary of the National League for Nursing (NLN), for home health agencies (HHAs) that wish to participate in the Medicare Program. As a result of this recognition, HHAs accredited by CHAP are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which CHAP must comply to maintain Medicare recognition of its HHA accreditation program.     

Procedures for disclosure or production of information under the Freedom of Information Act; amendments--Consumer Product Safety Commission. Final Rule

The Electronic Freedom of Information Act Amendments of 1996, which amend the Freedom of Information Act, are designed to make government documents more accessible to the public in electronic form. The amendments are also intended to expedite and streamline the process by which agencies disclose information generally. In this notice, the Commission amends its Freedom of Information Act regulations to comply with the requirements of the new statute.     

Giving the reasonable patient a voice: information disclosure and the relevance of empirical evidence

In England the standard of risk disclosure required of doctors to avoid liability in negligence is governed by the Bolam test. The test is determined by what would be accepted as reasonable by the responsible doctor. Although able to lay down an independent standard, the courts have usually been guided by the medical expert's evidence. The judge's duty to scrutinise expert evidence was reaffirmed by the recent House of Lords ruling in Bolitho v City and Hackney HA. In Pearce v United Bristol Healthcare NHS Trust, Lord Woolf MR confirmed that this also applied to risk disclosure. Brazier & Miola argue that Pearce effectively introduces the prudent patient standard into English law. This paper examines that claim and considers whether it is justified by the Pearce judgment. The implications of Pearce are explored and, given the appeal to the concept of a material risk, I discuss the relevance of empirical research to determining the standard of disclosure. Finally, a small piece of empirical work is presented as an illustration of the pros and cons of such an approach and as a possible springboard for future research.     

Approval of the Commission on Office Laboratory Accreditation--HCFA. Notice

This notice announces the approval of the Commission on Office Laboratory Accreditation (COLA) as an accrediting organization for clinical laboratories under the CLIA program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by Federal law and regulations. Consequently, laboratories that voluntarily become accredited by COLA in lieu of receiving direct Federal oversight and continue to meet COLA requirements would meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to validation and complaint investigation surveys.     

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.     

人体损伤致残程度鉴定标准中晋级原则研究

《人体损伤致残程度分级》(以下简称《伤残分级》)已于2017年1月1日起正式实施,《伤残分级》总则中没有采用"晋级原则".本文考证了国内现行有效的各伤残标准中关于"晋级"的适用情况、美国医学会制定的《永久性残损评定指南(第六版)》"晋级"的规定以及康复医学中的综合评定法.可以看出,"晋级原则"是国内外通行的伤残评定原则.晋级原则是伤残赔偿中的关键的技术问题,虽然《伤残分级》在具体条款(手功能)中有"晋级原则"的体现,但《伤残分级》在总则舍弃"晋级原则"可能会带来赔偿中的实务问题.笔者呼吁相关部门联合制定:多种损伤致残案件的伤残综合计算的"晋级方法",以解决实践中的迫切之需.