Friday, November 21, 2008

HHS Issues Final Rule for PSOs

Date: November 21, 2008
For Release: Immediately
Contact: AHRQ Public Affairs
(301) 427-1258
(301) 427-1855

The U.S. Department of Health and Human Services has issued a final rule for Patient Safety Organizations (PSOs).

The rule becomes effective on Jan. 19, 2009. It provides final requirements and procedures for PSOs, new entities, with which clinicians and health care providers can work to collect, aggregate and analyze data -- within a legally secure environment of privilege and confidentiality protections -- to identify and reduce patient care risks and hazards.

"I expect the final rule and the creation of Patient Safety Organizations to greatly improve the quality of health care for all Americans," HHS Secretary Mike Leavitt said. "By making it easier for clinicians and health care organizations to report and learn from adverse events without fear of new legal liability, we will be able to improve our nation's health care systems and minimize factors that can contribute to mistakes."

Under interim guidance issued on Oct. 8, AHRQ has already listed 15 PSOs. During the remainder of the interim period, these organizations will maintain their status as PSOs. However, these and other PSOs listed throughout the interim period are expected to comply with the final rule once it takes effect.

"The Patient Safety Organization final rule describes the clear, legally protected framework for how hospitals, clinicians, and health care organizations can work together to improve patient safety and the quality of care nationwide," said AHRQ Director Carolyn M. Clancy, M.D.

The listing of PSOs is authorized by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The Patient Safety Act is intended to encourage voluntary, provider-driven initiatives to improve the safety of health care through the establishment of legal protections to ensure that providers who report patient safety information do not incur new legal liability; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement.

The final rule is consistent with many of the provisions of the proposed rule issued on Feb. 12. However, it also includes new requirements for PSOs, such as:

  • The requirement that a PSO notify providers if the patient
    safety work product it submits is inappropriately disclosed or its security is breached
  • Requirements for how a component PSO maintains separation
    between itself and its parent organization(s) have been made more flexible.

The final rule also makes several important changes from those in the proposed rule regarding the listing and delisting of PSOs and the ways in which PSOs must comply with statutory requirements, including:

  • Expansion in the types of entities and organizations excluded
    from listing as PSOs
  • Revisions to how PSOs should disclose certain relationships with
    health care providers
  • Increased flexibility in how PSOs can store patient safety work
  • Automatic expiration of Departmental listing after 3 years
    unless a PSO's listing is continued by the Secretary and
  • An expedited delisting process for PSOs in a limited number of
    serious circumstances

AHRQ administers provisions dealing with PSO operations, and the HHS Office for Civil Rights (OCR) enforces confidentiality provisions. The final rule addresses concerns regarding how providers may efficiently collect and analyze patient safety event information with privilege and confidentiality protections while complying with existing reporting requirements that seek similar information.

"OCR is pleased to partner with AHRQ to protect and ensure the confidentiality of the information used by providers and PSOs to improve the safety and quality of patient care nationwide," said OCR Director Winston Wilkinson.

To read the final rule and access more information about PSOs, including background on the rulemaking process, visit AHRQ's PSO Web site at Additional information about the confidentiality and disclosure of patient safety work product may be found at OCR's Web site at

Tuesday, November 18, 2008

AHIC Advises HHS to Build Regulatory Compliance of EHRs

The American Health Information Community (AHIC) issued a recommendation to the Department of Health and Human Services (HHS), urging HHS to promote electronic health records (EHR) compliance.

AHIC encourages the creation of EHR templates to reduce redundancy in information collection. AHIC also encourages HHS to convene a panel of experts who can determine what licensing, regulatory, quality, and payment data should be included in EHR templates. These templates would be stored in a database accessible to the public.

To read more on AHIC's recommendations, click here:

Source: Government Health IT

AHRQ Launches Quality Measurement Clearinghouse

The Agency for Healthcare Research and Quality (AHRQ) has launched the National Quality Measures Clearinghouse (NQMC), a repository of the quality measurements and measure sets currently used by the Department of Health and Human Services for reporting data and determining payment.

Through this Web site, the public can access healthcare quality measures and apply them to their organizations when desigining their own policy and quality initiatives. The measures are updated on a weekly basis.

To access the NQMC, click here:

Thursday, November 13, 2008

Hospital Language and Culture Update Available Online

The Joint Commission's November 2008 Hospital Language and Culture (HLC) Project Update is now available online.

The HLC study explores challenges in providing quality healthcare when there are cultural or linguistic barriers between patients and providers.

The November 2008 Update can be found here:

Source: The Joint Commission

Wednesday, November 12, 2008

AHRQ Announces Ten Patient Safety Organizations

The Agency for Healthcare Research and Quality (AHRQ) has announced the first 10 Patient Safety Organizations (PSOs) recognized by the Department of Health and Human Services (HHS). AHRQ is the main agency within HHS responsible for improving healthcare safety, quality, and cost-effectiveness.

The 10 newly listed PSOs will collect quality data voluntarily reported by providers and healthcare organizations. Using this confidential data, they will issue recommendations on how to improve patient safety and reduce medical errors.

Each PSO was approved by HHS and given certification that went into effect on November 5. AHRQ will announce new PSOs weekly as HHS certifies more organizations.

The 10 PSOs announced by AHRQ are:

• California Hospital Patient Safety Organization (CHPSO) in Sacramento, CA;
• Missouri Center for Patient Safety in Jefferson City, MO;
ECRI Institute PSO in Plymouth Meeting, PA;
• Florida Patient Safety Corp. in Tallahassee, FL;
• Health Watch Inc. in Easton, MD;
• Human Performance Technology Group in Collierville, TN;
• Institute for Safe Medication Practices in Horsham, PA;
Peminic Inc. in Fort Washington, PA;
Sprixx in Santa Barbara, CA; and
• University Healthsystem Consortium in Oak Brook, IL.

Source: BNA

Tuesday, November 11, 2008

Joint Commission Accreditation: Lab Decisions Will No Longer Affect Hospital Decisions

Media Contact:
Ken Powers
Media Relations Manager

(OAKBROOK TERRACE, Ill. – November 4, 2008) Beginning January 1, 2009, under new Joint Commission policy, laboratory accreditation decisions will no longer immediately impact hospital accreditation decisions. This policy establishes comparability in the way that a laboratory with an adverse accreditation decision rendered by The Joint Commission or one of its cooperative partners, College of American Pathologists (CAP) or COLA, impacts the hospital or other organization with which the laboratory is affiliated. Currently, a laboratory’s accreditation has a direct impact on the accreditation status of its affiliated organization.

Under the new policy, the accreditation of laboratories and hospitals accreditation will continue to be linked, due to the critical importance of laboratory services to the delivery of hospital care. An adverse laboratory accreditation decision, whether due to survey by The Joint Commission, CAP or COLA, will help prioritize the hospital’s or other organization’s next unannounced survey.

“The new approach meets the needs of Joint Commission customers and reinforces the importance of the laboratory in the delivery of patient care,” says Ann Scott Blouin, Ph.D., R.N., executive vice president, Accreditation and Certification Operations, The Joint Commission.

The Joint Commission has been evaluating and accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995. Today, The Joint Commission accredits nearly 2,000 organizations providing laboratory services, representing almost 3,000 CLIA-certified labs, including freestanding labs. The Centers for Medicare & Medicaid Services (CMS) officially recognizes the Joint Commission Laboratory Accreditation Program as meeting the requirements of CLIA ’88.

Source: The Joint Commission

Wednesday, November 5, 2008

DNV Hosting Educational Sessions on NIAHO Accreditation

Det Norske Veritas (DNV), the latest hospital accreditation agency to be granted deeming authority by CMS, will be hosting a one-hour webinar and several day-long workshops to explain its National Integrated Accreditation for Healthcare Organizations (NIAHO) program.

Since CMS approved NIAHO on Sept. 26, hospitals have been asking:
  • How do we implement NIAHO?
  • How do the standards differ from TJC?
  • What impact can NIAHO have on our overall quality programs?

Attend a one-hour webinar, or for a full-day in depth workshop in a city near you.

Online Webinar:
Thursday, Nov. 6, 10:00 a.m. or 2:00 p.m. (ET)

Full-day Workshops:
Chicago, Nov. 11
Columbus, Nov. 13
Atlanta, Nov. 19
Houston, Nov. 20
Newark, Dec. 2

Breakfast, lunch and beverages are included in registration fee, along with complete program materials for the day-long workshops.

To register for the webinar or a workshop in your area, click here:,cgpz,mxa,j5ov,29q2,c13t,7hre

"Letter of Concern" Not a Violation of Due Process

A federal appellate court has ruled that a Nebraska statute authorizing "letters of concern" to be part of a physician's public record without prior notice to allow the physician to contest the letter is not unconstitutional (Kloch v. Kohl, 8th Cir., No. 07-2120, 11/3/08).

The U.S. Court of Appeals for the Eighth Circuit ruled that the Nebraska Uniform Licensing Law, which allows this practice, does not violate Dr. Gregory Kloch's right to due process because it has no significant and direct impact on his medical licensure or his ability to practice in the state.

Because a letter of concern does not necessarily constitute a disciplinary action, the state is not required to take immediate steps to revoke his license or take other measures to prevent a physician from practicing medicine.

The court stated that “Nebraska could not have disciplined a physician on the basis of conduct discussed in a letter of concern without first formally charging the physician and holding a hearing to test the allegations,” thus refuting the appellant's argument that the statute violates his right to appeal the concerns raised in the letter.

The court also ruled that because the letter of concern was posted to the department's Web site and available upon request, Kloch was given adequate notice to review and contest the letter against him.

Click here for the court's full opinion:

Source: BNA

Tuesday, November 4, 2008

HHS Inspector General Says CMS HIPAA Oversight Is Ineffective

An October 27 report from the Department of Health and Human Services Inspector General states that “limited actions” by CMS have “not provided effective oversight or encouraged enforcement of the HIPAA Security Rule by covered entities.”

The main concern of the report is that CMS relies on complaints in order to identify organizations to investigate for failure to comply with HIPAA regulations.

The HHS Inspector General admits that the audit cited in the report was performed in 2007, before CMS signed a contract in January 2008 with PriceWaterhouseCoopers to assist with compliance reviews. However, it still stands behind its recommendation that CMS take a more proactive approach to identifying HIPAA compliance issues.

CMS disagrees with the report. While compliance reviews would be beneficial, CMS believes that the complaint-driven system encourages voluntary compliance. It also stated that the Inspector General's report fails to highlight other steps taken by CMS to improve HIPAA compliance such as industry outreach, education, and complaint investigation and resolution.

Source: Government Health IT

Click here to view the HHS Inspector General's report:

Monday, November 3, 2008

CMS Sends Out Clarification Memo on Standing Orders

CMS sent an October 24, 2008 memo to State Survey Directors clarifying standing order documentation guidance that was issued in February and April.

The memo includes guidance revisions issued to physicians who use preprinted forms for standing orders. It also provides the following clarification regarding the use of rubber signature stamps:

"The CoPs [Conditions of Participation] do not prohibit the use of rubber stamps in a hospital setting, when properly controlled, for authentication of medical record entries. However, as a point of information for surveyors and providers, we are taking this opportunity to add an information-only statement to the interpretive guidance for §482.24(c)(1) to note that some payers, including Medicare, may not accept such stamps as sufficient documentation to support a claim for payment. "

Click here for the full memo: