It’s been an exciting year with our new president, Mark Chassin, M.D., at the helm. We have forged ahead with changes, innovations and revisions. You can read about some of these transformations in the following article.
I’m encouraged by these improvements and The Joint Commission’s new vision, “To collaborate with health care organizations to lead the transformation of health care into a high reliability industry.”
We are working hard to achieve this vision. First, we have internally launched Robust Process Improvement™, which is an integrated Lean Six Sigma approach. So far, we have trained 20 Green Belts and 20 Change Agents who are working with employees throughout the enterprise to improve customer service, standards development and communication. In addition, we are re-designing all aspects of the accreditation process ― pre-survey, survey and post-survey sub-processes with the goals of simplification, standardization, consistency and transparency to the health care organizations we serve.
We’re improving our processes in the same way that we require our accredited health care organizations to continually improve their processes. The result should be better care delivered to your patients. I welcome your suggestions in response to these ideas or any other thoughts about how The Joint Commission can strengthen its accreditation process to serve you better. You can contact me at mpeck@jointcommission.org or (630) 792-5287. I look forward to hearing from you.
Margaret Peck, M.S., M.T. (A.S.C.P.)
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Beginning January 1, 2009, adverse laboratory accreditation decisions will no longer immediately impact hospital accreditation decisions. A new policy approved by The Joint Commission Accreditation Committee establishes comparability in the way that a laboratory with an adverse decision — whether that decision is rendered by The Joint Commission or one of its cooperative partners (College of American Pathologists or COLA) — impacts the hospital with which the laboratory is affiliated.
“Under the new policy, the laboratory and hospital accreditation programs will continue to be linked, due to the essential nature of laboratory services, but any adverse laboratory accreditation decision will not have an immediate impact on the hospital’s accreditation decision,” says Margaret Peck, executive director, Laboratory Accreditation Program. “This approach is a good way to meet the needs of Joint Commission customers while reinforcing the importance of the laboratory in the delivery of patient care.”
This new Joint Commission policy establishes a “related impact requirement” for the laboratory and the hospital. “Related impact requirement” means that any adverse laboratory accreditation decision — whether a result of a Joint Commission, CAP or COLA survey — will be integrated into the Priority Focus Process (PFP). An adverse laboratory accreditation decision will serve as an information point in the PFP, along with other data, to prioritize and customize the hospital’s or other organization’s next survey, which, as a result, could occur earlier in the organization’s 18 to 39 month survey window.
For more information, contact Peck at (630) 792-5287 or mpeck@jointcommission.org.
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January 1, 2009, will ring in more than a new year for accredited laboratories. As a result of the Standards Improvement Initiative, many improvements will be implemented including newly revised standards chapters, a new scoring process and an E-dition (electronic version) of the accreditation manual. Here’s an overview of what you can expect.
Extensive work is ongoing to revise and reorganize the standards to make them clearer, eliminate redundancies and create a simpler, more logical order. The 2009 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing contains revisions to the Accreditation Participation Requirements, National Patient Safety Goals, Leadership and Life Safety chapters. In addition:
- The standards in the new chapters have a different numbering system to enable electronic enhancements.
- The other chapters retain the previous numbering system until 2010, when they will be re-numbered.
- Icons have been added to provide a guide to the requirements (see icon key).
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The new scoring and decision processes, effective January 1, 2009, focus on how critical an issue is to patient care or safety, based on the premise that some standards are more “critical,” or more directly impact the patient, than others. The more critical the issue, the shorter the time frame that an organization has to address it. Following are highlights of the revisions. For a complete description of the changes, see the December 2008 edition of Joint Commission Perspectives or the introduction to the 2009 CAMLAB.
- Decisions of Conditional Accreditation and Preliminary Denial of Accreditation will be driven by those standards that have the most direct impact on patient care or safety.
- There is no longer a supplemental section in the Accreditation Report. All findings of less than full compliance require resolution via submission of Evidence of Standards Compliance.
- The use of “thresholds” to determine Conditional Accreditation and Preliminary Denial of Accreditation has been revised. Program-specific thresholds will serve only as “screens” for identifying organizations whose survey findings require more extensive review by Joint Commission Central Office staff. The screens are based on the number of Direct Impact standards (see icon key) that are noncompliant.
- As requested by the field, Category B elements of performance have been re-categorized to either A or C. Category A reflects presence, absence or consistency and Category C is frequency based.
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New Icons
Icons will be used to identify the scoring category, measure of success designation, whether documentation is needed, and the criticality of certain elements of performance (EPs). The icons that will be used in the manuals and their meanings are defined below. An icon key is provided at the bottom of each requirement page. EPs that do not have a “2”or “3” icon are considered Indirect Impact requirements (level 4). No EP is tagged as an Immediate Threat to Life requirement; instead, an Immediate Threat to Life situation is usually the result of noncompliance with a combination of EPs at any or all of the Situational Decision Rules, Direct Impact and Indirect Impact levels.
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In response to feedback from accredited organizations, The Joint Commission has launched the E-dition, an electronic, searchable version of the accreditation manuals. All organizations receive one complimentary, single-user license E-dition. If an organization is accredited under more than one accreditation manual, it will receive one complimentary single-user license E-dition for each manual it is accredited under. This single-user license allows anyone in the organization to access E-dition on a one person at-a-time basis. The E-dition may be upgraded by purchasing a multi-use site license or additional single-user licenses.
Between November 14 and 21, accredited organizations received an e-mail from Joint Commission Resources (JCR) containing a password with a link for accessing E-dition. The e-mail was sent to the organization’s primary accreditation and Periodic Performance Review (PPR) contacts. Additionally, a link to the E-dition is posted on every organization’s Joint Commission Connect extranet. This link will be a single-user guest link specific to each organization and will provide staff with the convenience of accessing E-dition without providing a login and password.
For more information about the E-dition, visit the JCR website, or contact a JCR customer service representative at (877) 223-6866. If you need help accessing the E-dition, contact JCR E-dition Tech Support at (630) 792-5420.
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Q: Our lab sometimes sends tissue to another health care organization. Does this classify us as a source facility or “manufacturer?”
A: It depends. The Food and Drug Administration would consider a routine policy or practice of shipping tissue to another facility to be the activity of a manufacturer, even if it is infrequent. Such facilities are required to register with the FDA within five days of beginning operations and to update their registration every December. Registered facilities must comply with those federal regulations applicable to the operations that they perform. This is a free registration, available online.
However, your lab would not be considered a manufacturer if you were just returning unused tissue to the source facility. This is not considered distribution and does not require FDA registration. In addition, FDA registration would not be required in the rare and well-documented “urgent” situation. However, such urgent situations should be the exception to the rule. If there is a routine pattern of distribution, the FDA requires registration.
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The Joint Commission’s Blood Management Technical Advisory Panel met in early December and recommended that nine performance measures be moved forward for detailed specification development. The areas recommended include: transfusion indication, informed consent, blood administration, pre-operative testing, transfusion of multiple units, and specimen testing. The Joint Commission plans to test the measures to ensure their feasibility and reliability for national use. For more information, contact Harriet Gammon, M.S.N, R.N., C.P.H.Q., associate project director, at hgammon@jointcommission.org, or go to the Web site.
A free listing of all standards, policy revisions and requirement revisions published in Joint Commission Perspectives is available on the Web site under the “Joint Commission Requirements” section. See it online.
The Joint Commission is asking for your comments on the National Patient Safety Goals through December 24. Select any program (you may comment on more than one, but will need to repeat the process for each program you select). Click here to participate.
The Centers for Medicare & Medicaid Services publishes a number of brochures explaining the Clinical Laboratory Improvement Amendments (CLIA) requirements. They include:
Lab Focus, the free quarterly newsletter, is chock full of the latest news and information from the Laboratory Accreditation Program. Be the first on the block to receive the newsletter by signing up to receive it automatically at www.jointcommission.org/Library/Newsletters/list_serve.htm.
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Publications
2009 Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing Integrates standards, rationales, elements of performance, scoring, decision rules, National Patient Safety Goals, and policies and procedures for laboratories.
Order code: CLSM09, $265
2009 Laboratory Accreditation Standards
Spiral-bound edition of the manual designed for use in staff orientation, education and self-assessment.
Order code: LSM09, $110
2009 Accreditation Process Guide for Laboratories
Features updated self-assessment checklist questions for all elements of performance and new scoring information.
Order code: APGL09, $119
Education
Joint Commission Accreditation Summit
April 28-29, 2009, Rosemont, Ill.
Participants will receive the latest updates on the standards and accreditation process from Joint Commission executives and program leaders. Includes plenary lectures and breakout sessions.
For registration information or to order, call Joint Commission Resources, Inc., toll-free at (877) 223-6866, 8 a.m. to 8 p.m. C.T., or go online.
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- Laboratory Accreditation (630) 792-5287
- Standards Interpretation Group (630) 792-5900
- Laboratory Account Representative (630) 792-3007
- Customer Service (630) 792-5800
- Pricing Unit (630) 792-5115
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