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Alerts and Recalls

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Welcome to the January 19 issue of the Quality Insights Renal Network 4 e-newsletter. In this issue, we bring you information about product recalls, ICH CAHPS updates, CROWNWeb news, monthly patient education features, ESRD events, resources and much more. We encourage you to  contact us with any questions, concerns or suggestions.  
FDARecallFda medical device recalls

Nurse Assist Inc. Recalls Normal Saline Flush IV Syringes Due to Possible Burkholderia Cepacia Bloodstream Infections
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The normal saline flush is a plastic syringe filled with 0.9% Sodium Chloride. It is used to clear out medical devices that deliver medicine directly into the veins of a patient through a needle or catheter. These syringes are used by health care providers in hospitals or clinics before and after a drip medication is connected to a patent.

Read the official FDA release for detailed information. 

Tego Connector D1000, NM1000
The Tego Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdrawal of fluids to a patient through a cannula or needle placed in the vein or artery. The Tego is a needle-free capping device which closes the end of the catheter. The Tego will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needle stick injuries.

Read the official FDA release for detailed information.

The HHS Office for Civil Rights and Office of the National Coordinator for Health Information Technology have released a new 10-page Fact Sheet that explains how the HIPAA Rules permit disclosure of Protected Health Information (PHI) to support public health activities authorized by state or federal law and conducted by public health agencies.  The fact sheet also gives examples of sharing PHI in support of other important public health policies.  View the  Fact Sheet .

We will be providing a Network 4 Patient Education Sheet each month in 2017. These documents are also located on our website. Please provide all of your patients with this education sheet this month.   Also, we ask that you please encourage your facility's Patient  Representatives to pass out this educational information as well.  

ICHCAHPSGuidelinesGuidelines for Participation in the 2017 ICH CAHPS Surveys Released
Please view the information from the ICH CAHPS website regarding the administration of the 2017 ICH CAHPS Surveys.  For the large dialysis organizations, please review the information and contact your corporate offices should you have any questions about the process for your company.  The facility staff is not involved in the administration of the surveys.  

ICHCAHPSSpringSurveyAuthorizing a survey vendor for the 2017 ich cahps spring survey
All in-center hemodialysis (ICH) facilities that are switching to a different ICH CAHPS Survey vendor to administer the 2017 ICH CAHPS Spring Survey must change their vendor authorization on the ICH CAHPS website by 5:00 p.m. Eastern Time on February 28. Please note you must update the online vendor authorization only if the following applies.
  • Your facility is participating in the ICH CAHPS Survey for the first time during the 2017 Spring Survey; OR
  • Your facility is switching to a different survey vendor to administer the 2017 ICH CAHPS Spring Survey; OR
  • Your facility entered the 2016 Fall Survey as the last survey period for which the vendor would administer the survey when you originally submitted the authorization form.
If your organization will continue to use the same ICH CAHPS Survey vendor that was used to administer the 2016 ICH CAHPS Fall Survey, you do not need to update the online vendor authorization form.
If any of the above statements apply to your facility, you must update the online vendor authorization form for the 2017 ICH CAHPS Spring Survey on the ICH CAHPS website by the February 28, 2017 deadline. ICH facilities that served 30 or more survey-eligible patients in calendar year 2016 must administer both the 2017 ICH CAHPS Spring and Fall Surveys to be compliant with the Centers for Medicare & Medicaid Services quality reporting requirements. If the online vendor authorization form is not updated by the deadline, a sample will not be provided to a survey vendor, which means the 2017 Spring Survey cannot be administered.
The steps for authorizing a different vendor on the ICH CAHPS Web site are as follows: 
  • Login to the ICH CAHPS website.
  • From your personal dashboard, click "Authorize a Vendor." The system will then take you to the Authorize a Vendor page.
  • Select the "Switch to a different vendor" option from the "Select Action" drop-down list on the Authorize a Vendor page.
  • Select the name of your survey vendor from the vendor drop-down list.
  • Select the Beginning Survey Period for your new vendor. In this instance, you would select "2017 Spring Survey."
  • Do not enter an end date for your survey vendor unless you know that you will not be using this vendor for the 2017 Fall Survey.
  • Select the CCN(s) of ICH facility (or facilities) to which the authorization applies.
  • Click the "Submit" button.
  • No changes to vendor authorizations will be accepted after that date and time.
Please contact the ICH CAHPS Survey Coordination Team at 1-866-245-8083 or via e-mail at ichcahps@rti.org if you have any questions or need more information about the 2017 ICH CAHPS Survey.

CMS2744 Annual Facility Survey (CMS Form 2744) for 2016 Must Be Complete by February 15
All facilities must generate an Annual Facility Survey (Form 2744) for the year 2016 no later than February 15, 2017. Completed surveys must be error free when submitted to the Network for acceptance submitted no later than March 31, 2017. 

Please be aware that Batch Submitting Organizations (BSOs) such as DCI, DaVita, FMC and any other facilities that have data submitted electronically may still have 2016 data being loaded into CROWNWeb (CW) through the beginning of February. Be sure to regenerate as you work on the form in order to catch all updates via batch.

Access the training for completing Form 2744, which is available at the www.mycrownweb.org website.  

The link above will take you step by step through the 2744 process. Also, the CW Outreach, Communications and Training team will begin conducting training by next month. We will inform you as soon as those training dates are available.

Please remember that you are completing the survey for calendar year 2016. Therefore, you will be examining data for activity that took place between January 1, 2016 and December 31, 2016.

For more information, or if you have any questions, please contact Karen Hricak at (610) 265-2418 or by emailing khricak@nw4.esrd.net

PatientNewsletterlook for a new patient newsletter schedule in 2017
Network 4 will be implementing a quarterly distribution schedule for its patient newsletter in 2017. Look for both English and Spanish editions in March, June, September and December of 2017. 

ReducingInfectionWebinarWebinar: Reducing Infection in the Outpatient Dialysis Facility 
Join the Reducing infection in the outpatient dialysis facility - Results of the Standardizing Care to Improve Outcomes in Pediatric End stage renal disease (SCOPE) Collaborative webinar scheduled for January 31 at 3:00 p.m. ET.  The webinar is geared toward dialysis providers, but is open to all. Free CEs will be offered. Register here.  
Dial-In Number: 303-248-0285, Access Code: 6393927. For questions, contact
CouncilDatesMark your calendars: 2017 network council meeting dates
Quarterly Network Council meetings in 2017 will center around the topics of Patient Engagement and the Patient Representative Program.   Each facility is REQUIRED to have a facility staff representative attend one of the meetings EACH quarter .    

2017 Network Council Meetings Dates Remaining
  • April 11 and 12: Both days at 2 p.m.
  • July 11 and 12: Both days at 2 p.m.
  • October 10 and 11: Both days at 2 p.m.

NationalForumWebinarNational forum of ESRD networks webinar series: Webinar #4 - continuing the discussion; answering your questions
Presented by the Forum of ESRD Networks, this is an encore webinar to the 3-part series "The Experience of Care: Patients & Providers as Partners." This webinar will provide an opportunity to continue the discussions and answer your questions from the previous three webinars in the series. Discussion topics during this 4th webinar will center around two topics that received the most comments and questions:
  • Breaking down barriers to engaging professionals, administration and patients 
  • How to get started: Peer Mentoring & Patient Advocacy 
Be prepared to bring your questions, ideas and comments to this live webinar. CEs cannot be provided for this webinar. 

NRAAWebinarNRAA Webinar Opportunity: Strategic Staffing for Dialysis Programs
The National Renal Administrators Association (NRAA) is hosting a webinar on Wednesday, January 25 at 1:00 p.m. ET titled "Strategic Staffing for Dialysis Programs: Identifying Best Practices for Pediatric and Adult Care." Participants can expect to learn how to: 
  • Identify three elements of an actionable dialysis staffing plan; and 
  • Name two strategies to increase staffing flexibility. 
CNE contact hours are available to all participants at an additional cost of $5. The National Renal Administrators Association is approved by the California Board of Registered Nursing, Provider Number 10584, for 1 contact hour.

Webinar Registration is $15 for Non-Members.

ESRDResourcesESRD resources 

Looking for a Patient Support Group?
Sometimes it's helpful to talk about your journey to kidney health with peers that understand what you're going through. Check out our website periodically for information about local support groups near you, including upcoming meeting dates as they become available. 

Check out the ESRD NCC Information Exchange
The ESRD Network Coordinating Center (NCC) provides centralized coordination and support for the Medicare ESRD Network program. Each month, the ESRD NCC distributes an e-newsletter, known as the Information Exchange, that compiles the most important information from numerous ListServs and publications related to renal health. To sign up to receive this informative newsletter, please contact the ESRD NCC at ncc@ncc.esrd.net or visit the ESRD NCC website

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(610) 265-2418 
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This bi-weekly e-newsletter will serve as our primary method of communicating important news and updates. We encourage you to visit our Web site for the most up-to-date information or to contact us with questions, comments or suggestions.
This material was prepared by Quality Insights Renal Network 4 under contract with the Centers for Medicare & Medicaid Services (CMS). The contents do not necessarily reflect CMS policy.

Publication No. ESRD4-011017