Eleven Change Concepts were developed and implemented in 2003, by an interdisciplinary workgroup supported by a team from the Institute for Healthcare Improvement (IHI). The steady increase in the national AV fistula rates is attributed to the implementation of these 11 Change Concepts. “We hope that with the implementation of Change Concept 12 and 13 the AV fistula rates will continue to increase and CKD will be detected earlier,” says Jay Wish, MD, FFBI Clinical Consultant.

Change Concept #12
Modify hospital systems to detect CKD and promote AV fistula planning and placement
• Hospitals develop a comprehensive plan for early identification1 of patients with kidney disease to allow for interdepartmental coordination for protective measures programs to prevent nephrotoxicity or other causes of further kidney damage, to allow for vessel preservation, patient and family support, and vascular access planning and/or placement.
[1] Patients with eGFR <30 - 44 (CKD Stage 3B)

Change Concept #13
Support patient efforts to live the best possible quality of life through self-management
• Patient achieves optimum treatment outcomes and health status through collaborative knowledge-building related to CKD progression and treatment and through effective application of self-management interventions, such as self-monitoring and decision-making.
• Health care clinicians utilize techniques and strategies for the education of those who participate in vascular access education and management that are designed to encourage, enhance, and support patient self-management. This includes motivational interviewing, health coaching, and other patient empowerment strategies and techniques.

A Change Concept is simply a general notion or approach that has been found to be useful in developing ideas for changes that lead to improvement. The change concepts developed by the Fistula First Initiative are all concepts that are recognized as effective in improving the AV fistula rates in prevalent hemodialysis patients.

The entire Fistula First Breakthrough Initiative Change Package and tools to support the Change Concepts can be viewed in full on the FFBI website http://www.fistulafirst.org.

About the Fistula First Breakthrough Initiative

The Fistula First Breakthrough Coalition, consisting of the Centers for Medicare & Medicaid Services, ESRD Networks, and the entire renal community, works together to ensure that every suitable hemodialysis patient will receive the most optimal form of vascular access - which, in most cases, will be an arteriovenous fistula (AV fistula). The focus of the FFBI includes reducing catheter use and vascular access complications, both of which will make hemodialysis safer, more effective, and cheaper for all patients. Founded in 2003, the Coalition and the Initiative are managed nationally by the Mid-Atlantic Renal Coalition, which is headquartered in Midlothian, Virginia, and serves as the ESRD Network Organization for Washington, DC, Maryland, Virginia, and West Virginia. Learn more about Fistula First at www.fistulafirst.org.

By my count 584 comments have been submitted to Medicare in response to the ESRD Prospective Payment System Proposed Rule (you can view the comments here or download the continuously updated Excel file). I've read all the comments; the passion for the dialysis program and patients comes through above all. However, I'm concerned that for all the passion the commenters aren't closing the deal. The comments aren't closing the deal because many are not including an actionable solution...

...Without offering Medicare a concrete step they can take to avoid these bad clinical outcomes, without offering a solution, the commenters are leaving it to Medicare to both want to solve the problem and know how to solve the problem...

Read full article by Bill Peckham

Excerps taken from Dialysis From the Sharp End of the Needle - tracking industry news and trends, in advocacy, reimbursement, politics and the provision of dialysis (Dialysis & CKD Blog Report)

Lawrence M. Spergel, MD, FACS,1 Janet R. Lynch, PhD, CPHQ,2 Jefferson Rowland, M.Sc., COTR,3 and William M McClellan, MD, MPH4 studied treatment centers with an average of greater than or equal to 10 patients, and vascular access data for the 27 months between January 2007 and March 2009. The data included a census of the vascular access used for each patient.

The first study “Is the CMS Fistula First Target of 66% for Prevalent Arteriovenous Fistula (AV Fistula) Feasible?” found that the percent of treatment centers achieving the CMS target of 66% for prevalent AV fistulas increased from 6.1% to 12.7%, nationally, substantial variation across ESRD Networks.

The second study “Has Fistula First Caused an Increase in Catheter Prevalence?” found that there was a decline in the use of any catheter from 28.9% to 26.2% of prevalent patients. There was substantial variation in CVC use observed across treatment centers.

“These data are encouraging to the renal community,” says Jay Wish, MD, FFBI Clinical Consultant. “Since 2007 AV fistula rates have increased significantly in the US and to the surprise of many not at the expense of increased use of catheters.”

To view the abstracts in their entirety visit the FFBI website at www.fistulafirst.org under What’s New.

• PCT Certification: CMS regulations require certification of Patient Care Dialysis Technicians (PCTs) by April 15, 2010, for all PCTs who have been employed in dialysis facilities since October 14, 2008.
• Ongoing Certification Dates: PCTs hired after October 14, 2008, must be certified within 18 months of their date of hire.
• Approved Certification Programs: CMS has approved 3 National PCT certification programs and 10 State PCT certification programs as meeting CMS requirements.
• Obtaining CMS Approval of Certification Programs: National or State certification programs that desire CMS approval must show that their programs meet CMS requirements of (1) a qualifying standardized test; (2) an independently-proctored and protected test environment; and (3) ongoing re-certification. Requests for program review and approval should be addressed to ESRDSurvey@cms.hhs.gov.
• Attachments to Memo: Two appendices are attached to this Memorandum. Appendix A describes State PCT certification programs. Appendix B describes the National PCT certification programs.

Read more...

Appendix A: State PCT Certification Programs - States with Provisions or Requirements that Meet CMS Approval and Appendix B: National Commercial PCT Certification Organizations

All syringes, regardless of lot number, are subject to this recall.

These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico).

The syringes in these lots may have needles which detach from the syringe.

Read more...

Spire Biomedical is recalling all Decathlon and Decathlon Gold, Alta and Alta Gold chronic hemodialysis catheters
(coated and uncoated) for a small possibility that the catheter tubing could separate from the hub/bifurcation of the device.

Read more...

The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.

Read more...

The Directive will closely follow the Information contained in the following:
http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

Read more...

The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160.

This recall is being conducted because of a potential malfunction of certain units of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death. This recall does not impact any MPRs manufactured after March 2008.

Read more...

Philips announced on September 28, 2009 that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

Read more...

New Heparin to Ship Starting October 8

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Read more...

The Fistula First Breakthrough Initiative (FFBI) launches dynamic 508-compliant website www.fistulafirst.org.

The redesign includes a new Chronic Kidney Disease (CKD) page with resources for primary care providers, as well as an extensive bibliography of articles that will help increase AV fistula rates and an archives section that will help keep featured items current. The site also features a growing community of links to a number of related websites.

Health Literacy Month, celebrated each October, is a time when health literacy advocates around the world promote the importance of understandable health information. This month is a time for all health literacy advocates to let the world know why health literacy matters.

To learn more about Health Literacy Month, go to www.healthliteracymonth.org, email Helen Osborne at helen@healthliteracy.com or call 508-653-1199.

The Department of Health and Human Services (HHS)’s Office of the Inspector General (OIG) has released a report, “State and Local Pandemic Influenza Preparedness: Medical Surge,” in which the agency hoped to determine the extent to which selected states and localities have prepared for a medical surge in response to an influenza pandemic, and conducted and documented exercises that test their medical surge preparedness for an influenza pandemic. To access this report, CLICK HERE.

The OIG also released another report, “Local Pandemic Influenza Preparedness: Vaccine and Antiviral Drug Distribution and Dispensing,” which sought to determine the extent to which 10 selected localities:

• addressed in their planning documents the vaccine and antiviral drug distribution and dispensing components and preparedness items that we identified based on HHS pandemic influenza guidance
• conducted exercises related to vaccine and antiviral drug distribution and dispensing and documented these exercises with After Action Reports and Improvement Plans
• collaborated with community partners to develop and exercise their plans to distribute and dispense vaccines and antiviral drugs during an influenza pandemic.

To access this report, CLICK HERE.

Hartford Hospital Transplant Program presents the 4th Annual Interdisciplinary Transplant Symposium

Tuesday, October 13th, 2009
7:00 a.m. – 4:00 p.m.

Education & Resource Center (ERC)
Heublein Hall
560 Hudson Street
Hartford, CT 06102

Registration Information: Call Hartford Hospital’s Health Referral Service at (860) 545-1888 or toll free at (800) 545-7664. Please provide your name, your role, and the name of your institution.

The fees for this conference are (payable by credit card when you call to register):

• Hartford Hospital Employees - $25
• Non-Hartford Hospital Employees - $50
• Students – No Charge

Also, please encourage local public health, pharmacies, visiting nurses associations and other organizations sponsoring public seasonal flu clinics to list their flu clinics on the flu clinic website. All public H1N1 flu vaccinations clinics are required to be listed on this website.

Masspro has revised the clinic data entry process to enable providers to directly enter and edit data on their public flu clinics. The new process is as follows: before entering clinic data, you have to be registered. Select User Registration to the left. Only registered users can enter information for upcoming flu clinics. Once you have returned the registration form, you will get a confirmation within one business day. Once the registration has been confirmed, you can log in and enter data on your clinics. If you have already registered, you only have to log in. To register to post clinics on the flu clinic website, go to: https://ws1.masspro.org/flu/providers/index

For technical assistance with flu clinic registration, please see the contact information for our Help Desk:

Masspro Flu Clinic Finder Help Desk
Phone: 781-419-2580
Email: fluhelp@masspro.org
Monday - Friday
9 am - 5 pm EST

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

[09/16/2009 - Recall Notice - FDA]

Coffee House Conversations™ GET READY FOR AN EMERGENCY! Hosted by the National Kidney Foundation

The next call is: Get Ready for an Emergency!
Tuesday, September 15
7:00 p.m. - 8:30 p.m. ET

For more information and to REGISTER, please visit www.kidney.org/coffeehouse

On September 14, 2009, CMS released, for public review and comment, a proposed rule about a new payment system (see memo). This new payment system will be effective by January 1, 2011. The Medicare Improvements for Patients and Provider Act (MIPPA) requires case mix adjustment factors. The bundled rate will include dialysis services, certain routine drugs and lab tests.

This new payment system is a major change in reimbursement. The proposal is long and very detailed. All comments to CMS must be submitted by December 15, 2009

For more information, please see: http://www.cms.hhs.gov/ESRDPayment/ or to read the full test, please see: http://www.federalregister.gov/OFRUpload/OFRData/2009-22486_PI.pdf

Please submit your comments to:
The Office of Information
and Regulatory Affairs, Office of Management and Budget
Attention: CMS Desk Officer, CMS 1418-P
Fax: (202) 395-6974; or
Email: OIRA_submission@omb.eop.gov

This report provides recommendations by CDC’s Advisory Committee on Immunization Practices (ACIP) regarding the use of vaccine against infection with novel influenza A (H1N1) virus. Licensed vaccine is expected to be available by mid-October 2009. Highlights of these recommendations include;
1) the identification of five general population target groups for initial focus of vaccination efforts (pregnant women, persons who live with or provide care for infants aged <6 months, health-care and emergency medical services personnel, children and young adults aged 6 months–24 years, and persons aged 25–64 years who have medical conditions that put them at higher risk for influenza-related complications),
2) establishment of a priority for a subset of persons within the initial target groups in the event that initial vaccine availability is unable to meet demand, and
3) guidance on use of vaccine in other adult population groups as vaccine availability increases.

Full text

The U.S. Food and Drug Administration today announced it has issued an Emergency Use Authorization (EUA) for a another diagnostic test for the 2009 H1N1 influenza virus, whose spread has caused the virus to be characterized as a pandemic by the World Health Organization.

The EUA for the Focus Diagnostics Influenza H1N1 (2009) Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) diagnostic test is the third diagnostic test authorized under an EUA by the FDA since the public health emergency involving the 2009 H1N1 influenza virus was declared on April 26, 2009.

The EUA allows Focus Diagnostics to distribute the test to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high complexity tests. This test is not typically utilized in a doctor’s office—it is a complex laboratory test performed in an environment that has the necessary equipment. These tests are intended for use in the detection of the 2009 H1N1 influenza virus in patients with symptoms of respiratory infection.

Read full article>>

https://learningctr.redcross.org/

The ReadyRN Curriculum was authored and donated to the American Red Cross by Dr. Tener Goodwin Veenema, a leader in the field of disaster and emergency management. Red Cross ReadyRN was developed by Dr. Veenema in partnership with Disaster Health Services. It is an online curriculum consisting of 20 self-paced modules. The modules are consistent with the National Response Framework that provides interactive scenarios for Red Cross and other healthcare professionals to learn to manage healthcare needs in shelters, perform health assessments, disaster triage and respond to public health emergencies in communities across the nation.

Participants may choose to take all of the modules or select only those of particular interest. The modules may be taken in any order and are independent of each other. Participants must complete an evaluative assessment at the end of each module to receive a completion certificate.

Each Red Cross ReadyRN module qualifies for 0.2 CEU credit under the International Association for Continuing Education and Training (IACET) guidelines. More information on CEUs is located on the Continuing Education Units (CEU) pages of CrossNet.

The Red Cross ReadyRN course modules are available through the Red Cross Learning Management System 24 hours a day, 7 days a week.

Register: https://learningctr.redcross.org/elms/pws/portal.do?siteID=10029%5fResponse&landingPage=login
Log in: https://learningctr.redcross.org/elms/pws/portal.do?siteID=10029%5fResponse&landingPage=login

2009 Vascular Access Surgery Change in Physician Reimbursement
Level Payment Field for AVF & AVG

Supply of GSK's Adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) is sufficient to meet demand for routine adult usage of this vaccine as well as CDC's ongoing High Risk Adult Hepatitis B Initiative.

This information is published at: http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

As a follow-up to that declaration, HHS has been working tirelessly to educate the public about flu precautions. The Centers for Medicare & Medicaid Services (CMS) is assisting the CDC in spreading helpful information and education about the swine flu outbreak and preventive actions to slow its spread to your audiences. The widget to the left provides direct access to the CDC database for important and timely information including, investigation, "what you can do", as well as protection tips from the cause and spread of the disease and create better awareness of related symptoms.

All confirmed Swine Flu cases in New England ESRD patients should be reported to the Network office at 203-387-9332.

The CDC is actively investigating isolated human cases of swine influenza A (H1N1) in several states (CA, TX, OH, KS, NY) and is working closely with Canada and Mexico and with the WHO. The CDC is continuously updating investigation information

As with any infectious disease, CDC recommends that people should take everyday preventive actions.

Acting HHS Secretary declares a Public Health Emergency nationwide involving Swine Influenza A. Press Release

The Connecticut Department of Public Health (DPH) has issued a Precautionary Boil Water Notice for Hartford County. Chlorine will be added to the water to eliminate the presence of the discovered microorganisms. Dialysis facilities in Hartford County should be vigilant.

Please call the numbers listed below for further information.

CT DPH’s Drinking Water Section: 860-509-7333
The Metropolitan District Commission (MDC): 860-278-7850

April 08, 2009 - Recall Notice - FDA
March 31, 2009 - Customer Letter - ZOLL Medical
April 14, 2009 - KCER Notice to ESRD Networks

March 31, 2009 - Press Release - Caraco Pharmaceutical Laboratories, Ltd.
April 14, 2009 - KCER Notice to ESRD Networks

The month of April is National Donate Life Month, a time designated nationally to help raise awareness about the critical need for organ, tissue, marrow and blood donors and inspire people to register their decision to donate life. Every day in April, people across the U.S. make a special effort to celebrate the tremendous generosity of those who have saved lives by becoming organ, tissue, marrow, and blood donors and to encourage more Americans to follow their fine example.

To find out more information on how to become a registered donor, go to www.donatelife.net.

Memorandum Summary:

The major portions of the new ESRD Conditions for Coverage became effective on October 14, 2008. The Life Safety Code (LSC) components of these regulations became effective on February 9, 2009.

The LSC component for dialysis facilities includes Chapters 20 and 21 of the 2000 Edition of the National Fire Protection Association’s (NFPA) 101 LSC.

The ESRD regulation provides certain exceptions to the LSC provisions, including sprinkler systems, Essential Electrical Systems (EES), and fire drills. The regulation also provides for specific LSC waivers.

To read the full memorandum, click here.

On February 1, 2009, CMS will move, in a modified fashion, CROWNWeb from its testing environment to a production/implementation environment. We are pleased to announce that the software is available on schedule. CMS will launch CROWNWeb to a small, select group of providers across the country—both large- and small-dialysis organizations, as well as independent dialysis facilities.

Until facilities in Network 1 are phased into CROWNWeb implementation, they must continue to meet their reporting requirements, under the ESRD conditions for coverage, by submitting data using VISION and/or paper-based forms and reports.

Registration for QIPS (CROWNWeb User IDs/Password) and Batch (Delegation of Authority) continues. Support will be available to dialysis facilities from their local ESRD Network Organizations. Facilities can also call the CROWN Help Desk at 888-ESRD-HD1 or email ESRDHD1@esrd.net.

Network of New England will continue to communicate information to facilities as it becomes available.

The new 2009 AV Fistula Placement Fee Schedule includes a 30% increase in RVU's for AVF Surgical Code 36821, which can be found on page 70007 of the Federal Registry Vol. 73, No. 244.

To view page 70007 only, click here.

Public Health Preparedness: Strengthening CDC's Emergency Response
A CDC Report on Terrorism Preparedness and Emergency Response (TPER) Funded Activities

WASHINGTON—Measuring glomerular filtration rates from routine blood work may not be not a cost-effective way to identify people with chronic kidney disease, according to a study in the February issue of the Clinical Journal of the American Society Nephrology.

The findings indicate that the potential benefit that this commonly used procedure provides for identifying individuals with previously unrecognized CKD can be easily reversed by the consequences of false positive diagnoses of CKD.

To read the entire article, go to http://www.renalbusiness.com/hotnews/egfr-not-cost-effective.html#

On January 16, 2009, CMS held an urgent conference call with all ESRD Network Organizations to announce a MODIFIED plan of the implementation of CROWNWeb. See the memo below about the revised plan.

Modified Plan for CROWNWeb Roll Out