Merger Completed for ESRD Networks 4, 9 and 10!

ESRD Network 4, ESRD Network 9 and ESRD Network 10 have merged under The Renal Network, Inc., a not-for-profit corporation which has been the contract holder for ESRD Network 9 and Network 10 since 1996. Read the complete News Release (format: PDF, size: 227) about the merger.

Events


2010 NEPHROLOGY CONFERENCE
Location: The 2010 Nephrology Conference will be held on Thursday, April 29 at the HERSHEY LODGE in Hershey, PA. This Conference is a being jointly sponsored by Network 9, 10 and 4. Agenda: The agenda for this plenary session will include the economic impact of MIPPA, patient safety, end-of-life care in the dialysis unit, and innovative home therapies. More details and registration information will be posted to this site in February. Conference Information and Registration: Feel free to review our Conference Brochure (format: PDF, size: 1.2 MB) for information about our meeting. Registration is now being accepted via the registration form (format: PDF, size: 97 kb) or ONLINE. Hotel Reservations: The corporate rate of $169 per night (plus tax) is available at the Hershey Lodge for meeting participants. Please call the Reservations Department directly at 1-800-533-3131 to reserve your room. The Hershey Lodge will hold the block of rooms until March 11, 2010. You must mention our Group RESERVATION ID number #34587, in order to obtain our special rate. Exhibitor Information: Exhibition space is now being reserved for the Conference. Download flyer with detailed *Exhibitor Information* and to secure an exhibitor display space download, complete and return the *Reservation Form. REGISTER ONLINE!* (now accepting credit card AND check payments). The registration fee is $80.00 and will be in effect until April 25, 2010. On April 26, Same Day Registration Fee will be in effect and will increase to $100.00. REGISTER EARLY TO SAVE MONEY!

Updates

CMS has announced changes in claims reporting for dialysis adequacy, infection and vascular access – new reporting requirements will go into effect on July 1, 2010. --posted Tuesday, February 9, 2010 --
These changes are being made as mandated by the Medicare Improvement for Patients & Providers Act (MIPPA).
For additional information, download: The MIPPA-Quality Based Payment Program Billing Info a PowerPoint slide [PDF] presenting an overview of the changes. The “Billing Rg7 file” [PDF] contains complete details as provided by the CMS Manual System.
From the Data Department -- Sent February 2, 2010 -- Facility Survey (CMS-2744) for Dialysis Units / Patient Roster Report as of December 31, 2009 / Patient Events from 01/01/2009 to 12/31/2009 / Missing Forms (if applicable) -- These reports include data recieved in the Network 4 office and processed through December 31, 2009.
CMS requires facilities to validate their information to ensure an accurate and complete recording of ESRD patient activity. Your validation of the Patient Roster and your submission on the Facility Survey (CMS-2744) is due to be returned to the Network office by February 24, 2010. You may contact the Network office if there are discrepancies on the survey. Documentation is required for changes made to the survey (CMS-2744). Thank you for your continued support in data collection for CMS/Network. You should submit your patient roster, the CMS-2744, and supporting documentation via FAX 412-325-1811 or via regular mail: ESRD Network 4, 40 24th Street, Suite 410, Pittsburgh, PA 15222.
Patient Newsletter -- Fall 2009 -- Now Available -- See our Newsletter Page for our current, and previous, patient and facility newsletters.
From the Quality Improvement Department -- Fistula First QAPI Document -- Required from select units that demonstrated lower than expected prevalent fistula performance -- Due November 30, 2009.
From the Data Department -- Sent October 28, 2009 to All Units -- Quarterly Patient Roster Reports / Patient Events & Missing Forms Request / 2009 Semi-Annual Facility Forms Compliance Report -- These reports include data received in the Network 4 office through September 30, 2009. CMS requires facilities to validate their information to ensure an accurate and complete recording of ESRD patient activity. Your validation of the Quarterly Patient Roster is due to the Network office by November 20, 2009. You may return your roster, supporting documentation, or CAP (if needed) to the Network office via FAX or regular mail.
2008 Annual Report -- posted to our website on August 4, 2009. Visit our Annual Report Page to view this report.

2009 Influenza Key Points and Messages -- December 29, 2009

(New) On December 18, 2009 - MedImmune notified CDC and FDA that a potency in thirteen batches (called "lots") of nasal spray vaccine that had been distributed were later found to have dropped just below a pre-specified limit. The slight decrease in potency should not have any impact on vaccine efficacy. the manufacturer will send providers directions for returning any unused vaccine from these lots.
(Update) On December 7, 2009 - Sonofi Pasteur notified CDC and FDA that the potency in one batch (called a "lot") of vaccine in pre-filled pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that was later measured to be below pre-specified limits. this means that doses from these four vaccine lots no longer meet the manufacturer's specifications for potency. Sanofi Pasteur has sent providers directions for returning any unused vaccine from these lots.
(Update) As of Wednesday, December 23, 2009 - a cumulative total of 112,617,800 doses had been made available for ordering since vaccine shipping began. Of those available doses, 89,579,000 doses were injectable (flu shots) and 23,038,800 were LAIV (nasal spary vaccine).
(Update) Last week marked the first 100 million doses of 2009 H1N1 vaccine available for ordering.
(Update) As of Tuesday, December 22, 2009 - there were a total of 95,514,300 doses ordered.
(New) Some priority groups may not be able to find thirmerosal-free H1N1 flu vaccine due to a recent recall of pre-filled, pediatric 0.25ml single-dose syringes by Sanofi Pasteur licensed for children 6-35 months old.

Safety Alerts

Coumadin Samples Recalled -- July 14, 2010
Audience: health care professionals
Medpage Today® reports that blister-pack physician samples of the anti-clotting drug warfarin (Coumadin) have been recalled because of potential instability in the samples’ active ingredient.
Visit Medpage Today® to read the complete article on the recall, which includes lot numbers.
CDC Health Advisory -- June 1, 2010
Audience: health care professionals
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals not to use certain intravenous (IV) bags of metronidazole, ondansetron, and ciprofloxacin because of potential contamination.
Refer to the CDC Health Advisory (format: PDF, size: 26 kb) for complete information.
High-Dose Zocor and Increased Risk of Muscle Injury -- April 9, 2010
Audience: health care professionals
The U.S. Food and Drug Administration (FDA) announced an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possible other drugs in the "statin" class.
Refer to the Zocor FDA Announcement (format: PDF, size: 232 kb) for more information.
Tests Confirm That "New" Heparin Is Less Potent -- April 9, 2010
Audience: health care professionals and patients
An article found on medpageTODAY® reports FDA tests confirms heparin is 10% less effective.
For more information, read the full article on medpageTODAY® or visit the FDA Drug Safety Communication website.
FDA Announces a Immediate Temporary Suspension of Rotarix (GSK) Vaccine -- March 22, 2010
Audience: health care professionals
The FDA announced today a temporary suspension of the use of the rotavirus vaccine Rotarix, manufactured by GlaxoSmithKline (GSK). All Rotarix product is affected by this suspension.
See the Rotarix Vaccine Health Alert (format: PDF, size: 58 kb) provided by the Philadelphia Department of Public Health for more information on this suspension notice.
FDA Classifies Baxter's January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action as a Class I Recall -- March 3, 2010
Audience: dialysis health care professionals and home dialysis patients
Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.
For more information, see the Baxter Recall Notice (format: PDF, size: 327 kb) for complete details.
OneTouch SureStep Test Strips (LifeScan) -- March 1, 2010
Audience: health care professionals, diabetic patients and the public at large
LifeScan and FDA notified healthcare professionals of a voluntary recall of eight lots of OneTouch SureStep Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
See the One Touch Recall Notice (format: PDF, size: 216 kb) for more information related to this recall including lot numbers and contact information.
DRUG SAFETY COMMUNICATION - Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp -- February 17, 2010
Audience: health care professionals, dialysis patients and the public at large
FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide (format: PDF, size: 48 kb) explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA.
Patients with chronic kidney failure (includes patients on dialysis and those not on dialysis) using ESAs should:
- Know that the use of ESAs can increase the risk for stroke, heart attack, heart failure, blood clots, and death.
- Read the Medication Guide (format: PDF, size: 48 kb) to understand the benefits and risks of using an ESA.
- Get blood tests while using ESAs. The test results may help guide the course of therapy and lower the risks of using these drugs. Patients' healthcare professionals should make them aware of how often to have blood tests.
- Talk with their healthcare professional about any questions they have about the risks and benefits of using ESAs.
See the complete ESA Drug Safety Communication (format: PDF, size: 290 kb) for more information.
RECALL: Spire Biomedical Catheter Tubing -- February 2, 2010
Audience: dialysis health care professionals and patients
Spire Biomedical, Inc of Bedford, MA announced a voluntary Class II recall of several dialysis devices. There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device.
For the complete list of the 48 devices affected by this recall, please review the Devices Recall Notice (format: PDF, size: 90 kb)
RECALL: Edwards Lifesciences Aquarius Hemodialysis System -- January 29, 2010
Audience: dialysis health care professionals and patients
FDA and Edwards Lifesciences notified healthcare professionals of a Class I recall of the Aquarius Hemodialysis System due to reports of clinically significant fluid imbalance and the potential for users to repeatedly override the fluid imbalance alarm. This could result in a decrease or increase in the volume of the circulating blood, which may result in serious injuries or death.
For affected model numbers and important contact information, see the Aquarius Hemodialysis System Recall Notice (format: PDF, size: 128 kb).
Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes -- January 25, 2010
Audience: health care professionals, patients and public at large
Nipro Medical Corporation is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump).
See the GlucoPro Insulin Syringe Recall Alert (format: PDF, size: 129 kb) for more information.
New OSHA Videos Feature Guidance on Respirators -- January 19, 2010
Audience: health care professionals
The Occupational Safety and Health Administration (OSHA) has developed two new videos for healthcare workers that feature training and guidance on respirator safety. According to OSHA's respiratory protection standard 29 CFR 1910.134, respirators must be used as part of a comprehensive respiratory protection plan.
See the following links: OHSA website = http://www.osha.gov/SLTC/respiratoryprotection/index.html#trainingvideos and YouTube = http://www.youtube.com/usdepartmentoflabor
Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pre-Filled Syringes -- December 16, 2009
Audience: health care professionals and public at large
The CDC announced that certain lots of sanofir pasteur's H1N1 vaccine packaged as pre-filled 0.25mL syringes were being recalled. There are no safety or efficacy issues with these lots, and all other brands and presentations of H1N1 vaccine are entirely unaffected.
See the Philadelphia Department of Public Health - Health Advisory (format: PDF, size: 35 kb) for more information.
Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators -- October 12, 2009
Audience: emergency or medical personnel, persons having competed CPR AED training courses, and public at large
Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR).
For lot numbers and additional information, see the Unomedical MPR Alert (format: PDF, size: 110 kb).
Philips issues Worldwide Recall of Select Heartstart FR2+ Automated External Defibrillators -- October 5, 2009
Audience: emergency or medical personnel, persons having competed CPR AED training courses, and public at large
Philips announced today 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 models manufactured between May 2007 and January 2008 are included in this voluntary recall.
For affected model numbers and additional information, see the Philips AED Recall Alert (format: PDF, size: 111 kb).
New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments -- October 1, 2009
Audience: healthcare professionals
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.
For more information, see the New USP Standard Heparin Alert Document (format: PDF, size: 116 kb).
Recall: Physio-Control LIFEPAK CR PLUS Automated External Defibrillators -- September 16, 2009
Audience: emergency or medical personnel, persons having competed CPR AED training courses, and public at large
An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
For a list of serial numbers affected by this Class 1 Recall, see the LIFEPAK Recall Alert Document (format: PDF, size: 145 kb).
Myfortic (mycophenolic acid) -- September 3, 2009
Audience: renal, cardiac, and hepatic transplantation healthcare professionals.
Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REASCTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.
For more information, see the Myfortic Alert Document (format: PDF, size: 101 kb).
H1N1 Influenza Vaccine Information -- September 1, 2009
Audience: dialysis and transplant unit administrators
For Pennsylvania Units = Letter from the Pennsylvania Department of Health (format: PDF, size: 194 kb)
For Philadelphia Units = Special Instructions for Philadelphia Units (format: PDF, size: 40 kb)
For Delaware Units = Letter from the Delaware Division of Public Health (format: PDF, size: 309 kb)
From CMS regarding BILLING = This article (format: PDF, size: 73 kb) explains Medicare coverage and reimbursement rules for the H1N1 vaccine. All providers administering this vaccine should review this article and be sure that their billing staffs are aware of this information.
Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] -- August 24, 2009
Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals
Qualitest Pharmaceuticals, Inc., today has issued a voluntary nationwide recall of two lots of Accusure® Insulin Syringes. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.
For the lot numbers affected, see the Accusure Insulin Syringes Alert Document (format: PDF, size: 136 kb).
Serious Errors with Certain Blood Glucose Monitoring Test Strips -- August 13, 2009
Audience: diabetic patients and/or their caregivers
NEVER use GDH-PQQ glucose meters or test strips if you are using drug products or therapies that contain ccertain sugars other than glucose.
See the Test Strip Alert Document (format: PDF, size: 189 kb) for complete information.
FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ Glucose Monitoring Technology -- August 13, 2009
Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals
This is to alert you to the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars.
For more information, read the full FDA Public Health Notification Document (format: PDF, size: 196 kb).

Reminders

The 10th Day of Each Month -- Your Monthly Patient Activity Report (mPAR) is due to the Network office -- Please fax your report to the attention of the "Data Department" at (412) 325-1811.
The 15th Day of Each Month -- For non-Large Dialysis Organization units, your Vascular Access Utilization Collection Form is due to the Network office -- Please fax your form to the attention of the "Quality Department" at (412) 325-1811.
CROWNWeb -- Network 4 will not be in the first release of CROWNWeb. Please continue to submit all information to the Network office per normal business requirements.