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
|
|
|
January 2012 marks the start of the CMS ESRD Quality Incentive Program (QIP). The program reduces reimbursement up to 2% based on a dialysis clinic's Total Performance Score, which measures anemia management and dialysis adequacy. Performance Year 2012 -- which determines your unit's reimbursement rate in 2014 -- has a number of new measures, including: Reporting healthcare infections via the Centers for Disease Control and Prevention (CDC) software, NHSN - National Healthcare Safety Network. Join us as we explain how you can get started with reporting Dialysis Events to the National Healthcare Safety Network. |
|
The Renal Network, Inc. has partnered with Quality Insights Renal Network 3 and is offering a four-week webinar series to assist facilities with NHSN. Network 3 has over two years experience with dialysis facility NHSN enrollment and has offered to provide these educational webinars at 2:00 PM every Friday in January starting with January 6, 2012. It is recommended that facilities -- especially independent, small or medium-sized corporate units -- attend all four webinar sessions. Due to scheduling constraints, these session will not be repeated. However, the recordings of these webinars will be made available on our website. Registration is required to attend the live session or to view the recordings. REGISTER FOR EACH SESSION BY CLICKING THE LINKS BELOW ...
|
|
Q: When do facilities need to start reporting? Q: How many months do I need to report data to NHSN for the CMS ESRD QIP rule? Q: When should we start enrolling our facility in NHSN to meet the reporting deadline for the CMS ESRD QIP rule? |
Updates
- CMS has announced a new release date for CROWNWeb 4.0 -- National Release. Originally scheduled for February 2012, the release date will be in March 2012.
Public Health -- Advisory Notices
- Excessive Heat Warning -- July 20, 2011
The City of Philadelphia shared with the Network 4 an "Excessive Heat Warning". (format: PDF, size: 173 kb)
This information is pertinent to the entire Network area as temperatures this summer continue to climb. - Influenza Transmission Has Begun Locally -- December 16, 2010
Refer to advisory message Influenza Transmission Philadelphia 12/16/2010 (format: PDF, size: 103 kb) for more information. - Revised Tuberculosis Report Form -- December 10, 2010
Refer to advisory message Revised Tuberculosis Report Form 12/10/2010 (format: PDF, size: 57 kb) for more information.
Safety Alerts
- Recall -- H&P Industries Providone Iodine Swabsticks, Prep Solutions, Scrub Solutions and Prep Gel -- August 30, 2011
Audience: Pharmacy, Consumer, Risk Manager
Due to inadequate microbial testing, this recall has been initiated at the request of the FDA.
Refer to the H&P Industries Providone Iodine Recall Announcement (format: PDF, size: 94 kb) for product types, lot numbers, background, and recommendations. - Recall -- Arrow NextStep Antegrade Chronic Hemodialysis Catheter -- August 3, 2011
Audience: Risk Manager
The FDA has notified healthcare professionals of a Class I recall of certain Arrow NextStep Antegrade Chronic Hemodialysis Cetheters, due to reports of breakage and/or separation of the stylet. These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina and Tennessee.
Refer to the Arrow NextStep Recall Announcement (format: PDF, size: 97 kb) for product and lot numbers, background, and recommendations. - Safety Announcement -- Nulojix (belatacept) -- July 8, 2011
Audience: Transplantation, Nephrology
Bristol-Myers Squibb informed healthcare professionals about the Risk Evaluation and Mitigation Strategy (REMS) that is required for Nulojix to ensure that the benefits of Nulojix outweigh the risks of post-transplant lymphoproliferative disorder (PTLD) and progressiv multifocal leukoencephalopathy (PML), both of which may be fatal.
Refer to the Nulojix Safety Announcement (format: PDF, size: 118 kb) for additional background and recommendataions. - Safety Announcement -- Erythropoiesis-Stimulating Agents (ESAs) in Chronic Kidney Disease: Drug Safety Communication -- June 28, 2011
Audience: Nephrology, Oncology
The FDA is working to inform healthcare professionals that new modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents is patients with chronic kidney disease (CKD) have been approved in order to improve the safe use of these drugs.
Refer to the ESAs in CKD: Drug Safety Communication (format: PDF, size: 94 kb) for additional information. - Recall -- H&P Industries Povidine Iodine Prep Pads -- March 21, 2011
Audience: Pharmacy, Consumer, Risk Manager
H&P Industries, Inc., a manufacturer of over-the-counter products, has issued a voluntary recall of ALL LOTS of Povidine Prep Pads which are private labeled for many accounts.
Refer to the Povidine Prep Pads Recall KCER FDA Safety Announcement (format: PDF, size: 175 kb) for additional information and recommendations. - Recall -- American Regent Injectable Products -- March 21, 2011
Audience: Pharmacy
Recall issued due to some vials exhibiting translucent visible particulate matter consistent with that of glass.
Refer to the American Regent Injectable Products Recall KCER FDA Safety Announcement (format: PDF, size: 135 kb) for product information, lot numbers, and recommendations. - Voluntary Recall -- CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor -- January 20, 2011
Audience: Risk Manager
Fresenius Medical Care North America has announced a voluntary recall of specific lots of CombiSet True Flow Series™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors (part Numbers 03-2695-9 and 03-2795-7) for use with the Blood Volume Monitor.
Refer to the CombiSet Recall KCER Safety Announcement (format: PDF, size: 238 kb) for additional information, lot numbers, and recommendations. - Triad Alcohol Preps Pads, Alcohol Swabs, and Alcohol Swabsticks Recall -- January 7, 2011
Audience: Pharmacy, Consumer
The Triad Group has issued a recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. The recall pertains to all such products marked as either sterile or non-sterile. The recall was initiated over concerns of possible microbial contamination.
Refer to the Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Recall KCER FDA Safety Announcement (format: PDF, size: 93 kb) for packaging details, recommendations and adverse reporting contact information. - (AngioScore Inc.) AngioSculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter OTW 0.018" Platform Class 1 Recall -- January 5, 2011
Audience: Rish Manager, Cardiology
Recall due to a design defect that could lead to unintended "fracture and peeling" of the bond and/or detachment of the distal end of the scoring element.
Refer to the AngioScore Inc AngioSculpt Class 1 Recall KCER FDA Safety Announcement (format: PDF, size: 196 kb) for model numbers, lot codes, background, recommendations and adverse reporting contact information. - Nationwide Voluntary Recall of Sodium Becarbonate Injections -- December 29, 2010
Audience: Hospital Risk Managers, Pharmacy, Emergency Medicine
American Regent has issued a voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials. Some vials may contain particulates.
Refer to the American Regent Sodium Bicarbonate Injection Recall KCER FDA Safety Announcement (format: PDF, size: 144 kb) for lot numbers, background, recommendations and adverse reporting contact information. - Abbott Glucose Test Strips Recall -- December 22, 2010
Audience: Endocrine, Patients, Pharmacy
The FDA and Abbott Diabetes Care are working to notify healthcare professionals and patients regarding the recall of 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ and ReliOn Ultima. The issue relates to the insufficient absorption of blood into the test strip. Strips that have either been exposed to warm weather or prolonged storage may have a higher likelihood of providing a false result.
Refer to the Abbott Glucose Test Strips Recall KCER FDA Safety Announcement (format: PDF, size: 120 kb) for background, recommendations and contact information. - addEASE Binary Connector Class 1 Recall -- December 1, 2010
Audience: Risk Manager
When the addEASE binary connector is inserted into a partial additive bag (PAB) stopper, fragments of the stopper may enter the bag, resulting in a small amount of visible particles in the solution. The particles can potentially enter the patient's body and lead to serious adverse health consequences.
Refer to the B. Braun addEASE Binary Connector Class 1 Recall KCER FDA Safety Announcement (format: PDF, size: 196 kb) for recommendations and contact information. - Sigma Spectrum Infusion Pump Class 1 Recall -- November 15, 2010
Audience: Risk Manager, Nursing
FDA notified healthcare professionals of the class 1 recall of the SIGMA Spectrum Infusion Pump Model 35700. These units may fail suddenly, causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow.
Refer to the Sigma Spectrum Infusion Pump Model 35700 Class 1 Recall KCER FDA Safety Announcement (format: PDF, size: 172 kb) for recommendations and serial numbers. - Triton Pole Mount Infusion Pump Recall -- November 11, 2010
Audience: Patient, Risk Manager
WalkMed Infusion LLC notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR2559, manufactured and sold before June 2010. If the pump door is not closed and latched per the instructions for use located on the side of the pump and in the operator manual, the pump door open alarm may not alert the user to this condition. It is then possible for the pump mechanism not to be engaged and a gravity feed flow condition to exist if the pump operator has not checked tube set for flow prior to starting the pump. This could result in over infusion of medication.
Refer to the Triton Pole Mount Infusion Pump KCER FDA Safety Announcement (format: PDF, size: 92 kb) for recommendations and reporting information. - Heparin Sodium Recall -- October 29, 2010
Audience: Pharmacy, Risk Manager
B. Braun Medical Inc and FDA notified healthcare professionals of a nationwide recall of certain lots of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun. Testing indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.
Refer to the Heparin Recall KCER FDA Safety Announcement (format: PDF, size: 92 kb) for additional information. - CareFusion Corporation Alaris PC Unit Recall -- October 15, 2010
Audience: Risk Manager
Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen (Model 8015). This error may result in a delay of therapy and inability to make programming changes to current infusions.
Refer to the Alaris PC Unit KCER FDA Safety Announcement (format: PDF, size: 136 kb) for recommendations and adverse reporting information. - Excelsior Medical Prefilled Saline Flush Syringes Recall -- October 15, 2010
Audience: Risk Manager
Routine internal testing conducted found that some syringes may leak and lose sterility.
Refer to the Excelsior Flush Syringes KCER FDA Safety Announcement (format: PDF, size: 174 kb) for produce code numbers and contact information. - EPOGEN® and PROCRIT® Voluntary Recall -- September 24, 2010
Audience: dialysis patients and health care professionals
Amgen announced that certain lots of EPOGEN(R) and PROCRIT(R) (Epoetin alfa) vials are being voluntarily recalled from specialty distributors, wholesalers, pharmacies and healthcare providers as a precaution. The product that is being recalled may contain extremely thin glass flakes (lamellae) that are barely visible in most cases. The lamellae result from the interaction of the formulation with glass vials over the shelf life of the product. The recall is being conducted in cooperation with the United States Food and Drug Administration.
Refer to the EPOGEN® and PROCRIT® KCER Alert Publication (format: PDF, size: 225 kb) for lot numbers and contact information. - Fresenius Urgent Recall for AC Power Cords -- September 10, 2010
Audience: dialysis patients and health care professionals
Fresenius Medical Care is initiating this recall for certain Fresenius devices that may have a defective plug, which is part of an AC power cord manufactured by Electri-Cord Manufacturing Company. Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
Refer to the KCER Alert Publication (format: PDF, size: 330 kb) for a list of affected products and more information - 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.
- 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
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.
