The FDA has advised that when the recall of Fresenius NaturaLyte Liquid Bicarbonate Concentrate (Part Number: 08-4000-LB) was upgraded to Class I (see https://nwrnbulletins.wordpress.com/2014/05/26/recall-fmc-naturalyte-bicarb-concentrate-2/), nine additional lots were added to the recall. For details and all lot numbers, see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm. Class I recalls indicate the possibility of serious injury or death.
We’ve published our latest quarterly Modality Reports (Dialysis Patient Census), for March 31, 2014, at http://www.nwrenalnetwork.org/modality/mode0314/Modality.htm. Montana has averaged a 5.7% annual gain in chronic dialysis patients over the last two years, Idaho 4.6%, Oregon 4.1%, Alaska 3.6%, and Washington 2.5%, for a 3.6% annual growth rate in the Network as a whole. Helping to meet the increased demand, thirteen new dialysis facilities have opened in the last year. Since March 2013 data was incomplete, we’re calculating our growth rates by comparing March 2014 to March 2012, then adjusting the changes to annual rates.
Home peritoneal dialysis has averaged a remarkable 7.9% annual growth, while home hemodialysis has grown 3.2% per year, and in-center hemodialysis 3.0%. Consequently, 16.1% of Network patients now dialyze at home, compared to 15.2% in 2012. Oregon saw the largest relative increase in home PD patients, averaging 16.7% growth per year. Alaska home PD patients increased by 10.1% per year, Washington 6.0%, Montana 2.5%, and Idaho 1.1%.
We’ve added instructions for patients on how to use the Hemodialysis Hand Hygiene Audit Tool, to the Network website. Find it in the Infection Control Campaign section of our Learning and Action Network (LAN) page, at http://www.nwrenalnetwork.org/QI/LAN/LAN.htm#inf. Hand Hygiene is a first line of defense in preventing infection, reducing hospitalization, and enhancing survival.
The FDA has announced that the previous recall of Fresenius Series 2008 HD/HHD machines (https://nwrnbulletins.wordpress.com/2014/01/17/recall-fresenius-series-2008-hdhhd-machines/) has been amended to include “Revision K” Actuator Test Boards sold as replacement parts. For a list of serial numbers affected, see http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1618-2014&w=05212014&lang=eng.
The recall of FMC’s NaturaLyte Bicarb Concentrate has been upgraded to Class I, meaning that serious injury or death can result from use of the recalled product. For product codes and lot numbers, see our earlier post at https://nwrnbulletins.wordpress.com/2014/04/21/recall-fmc-naturalyte-bicarb-concentrate/. For the FDA announcement of the upgrade, see http://www.fda.gov/Safety/Recalls/ucm398488.htm.
QIP Results for 2014 (CY2013, PY2015) are in, and Network 16 has done well. Nationally, 4.7% of facilities received payment reductions in 2014; the equivalent rate in this Network was only 2.9%. Only two other Networks had lower percentages. Our 2.9% rate is a big improvement from last year’s 12%, which in turn was better than the prior year’s 22%.
So Northwest Renal Network facilities have good reason to celebrate, and deserve a hearty Congratulations and heartfelt Thanks from one and all for their high quality of service!
Every Network payment-reduced facility was docked for a different reason, so there is no pattern in our opportunities for improvement. Two payment-reduced facilities are repeats from last year, and one of those also received payment reduction in the prior year. Network staff will be working with all payment-reduced facilities, to bring all Network facilities up to the highest quality standards.
The FDA has announced a Class I recall of version 9.1.18 of the software in the Alaris Infusion Pump model 8100 made by CareFusion 303, Inc, because the “delay until” and “multidose” options may malfunction. For details see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398178.htm. Class I recalls are used when serious injury or death may result.
CDC and APIC (the Association for Professionals in Infection Control and Epidemiology) will provide a FREE webinar on infection control considerations for MERS-CoV on May 28, 2014. CDC’s Dr. Michael Bell will review infection prevention and preparedness strategies to help facilities know what to look for and what to do to protect healthcare providers and patients in their facilities. For details and registration see http://content.govdelivery.com/accounts/USCDC/bulletins/b958a5.
CROWNWeb Version 4.4 Training and Town Hall Events Now Open for Registration
CMS has announced the upcoming release of CROWNWeb 4.4, which will be available on May 28, 2014. This release features a number of enhancements to the Clinical screens in CROWNWeb designed to streamline the entry of required data.
Major modifications and enhancements in this release include:
Educational and Informational Events
To support the launch of CROWNWeb 4.4, CMS is happy to announce the following community events. Click on a More Info/Register link to view detailed information on that event and to register:
| Event Name | Date | Information and Registration | ||
| Training – What’s New in CROWNWeb 4.4 Brief synopsis and introductory training on major enhancements in CROWNWeb 4.4 |
5/28/2014 2:00 PM ET |
|
||
| Town Hall – Introducing CROWNWeb 4.4
Introduction to CROWNWeb 4.4, its major components, and how these new features must be utilized by facilities. Also includes information on upcoming community events, and an update from CMS. |
5/29/2014 2:00 PM ET |
|
||
| Training – What’s New in CROWNWeb 4.4 Brief synopsis and introductory training on major enhancements in CROWNWeb 4.4 *repeat of 5/28 session |
5/30/2014 2:00 PM ET |
|
||
| Training – What’s New in CROWNWeb 4.4 Brief synopsis and introductory training on major enhancements in CROWNWeb 4.4 *repeat of 5/28 and 5/30 sessions |
6/2/2014 2:00 PM ET |
|
All events will be recorded and published on http://www.projectcrownweb.org for on-demand viewing at any time.
Additionally, supplemental training materials supporting CROWNWeb 4.4 (Online Tutorials, help topics, and FAQs) will be published in the days following the CROWNWeb 4.4 release. Be sure to check the Project CROWNWeb website at http://www.projectcrownweb.org for updates!
Questions? Contact CROWNWeb Outreach, Communication, and Training
at http://www.projectcrownweb.org or email craft@projectcrownweb.org.
NxStage has announced a recall of their SAK Dialysate Concentrate, SAK-301 through -307, and -407 because of elevated aluminum levels. For details and lot numbers see http://ww2.nxstage.com/rs/nxstagemedicalinc/images/NxStage%20Recall%20Notice%205%2015%202014%20Updated.pdf.
esrdbulletins 