The Lone Star Bulletin, The End Stage Renal Disease Network of Texas

Our Network

The Lone Star Bulletin - June 2008

The draft 2007 Network #14 Annual Report has been submitted and final approval by CMS is expected in early July. At that time you will be notified when the report is posted to the website for downloading and viewing and instructions will be provided on how to request a hard copy if desired. Following is some preliminary data as of 12/31/2007 in Texas:

Patients

The incidence of ESRD decreased from 379 per million in 2006 to 369.9 per million.
The unadjusted prevalence continued to increase and was 1,352 per million.
41,607 persons were receiving renal replacement therapy (dialysis and transplant combined) in Texas, a 4.8% increase in prevalent patients. Of these:
- 32,383 were either receiving hemodialysis or peritoneal dialysis
- 2,502 were on home dialysis
- 9,224 were transplanted
- 8,840 newly diagnosed persons with ESRD began receiving dialysis, a <1 percent decrease from 2006
After a multi-year decrease involuntary patient discharges increased from 32 patients in 06 to 44 in 07.

Providers

417 Medicare approved dialysis facilities with 8,529 dialysis stations were located in 107 of the 254 Texas counties.
Harris County (Houston area) has the most facilities (n=72), Bexar County (San Antonio area) the second highest number (n=45) and Dallas County (Dallas area) the third highest number (n=36). Even when Fort Worth (n= 27) is combined with Dallas to encompass the DFW Metroplex with 63 facilities, the area trails Houston.
The majority of facilities are owned by National Corporations. Between 2006 and 2007, the proportion of facilities owned by national dialysis corporations increased from 80 to 81% while independently owned facilities remained the same at 9% and regional chains decreased from 6% to 5%.
There are 24 transplant Centers; however, 2 were inactive at year-end.

Forms and Events processed

The NW processed and validated 9,492 Chronic Renal Disease Medical Evidence Reports (CMS Form - 2728), and 6,248 ESRD Death Notifications (CMS Form - 2746) and 5,160 Patient Activity Reports with 34,328 patient events.

In the next few weeks each facility will receive a letter with information about the Crown-Web System that certified facilities would be required to use as of February 2009.

CMS has completed their evaluation of Network #14 and we received a score of 94.5%. Among other things in the coming year we will be working to:

Increase self-care and home dialysis.
Demonstrate that information that the NW disseminates to both patients and providers is effective and we will NEED YOUR HELP to do this! Already several facilities have been asked to volunteer as test groups and, if your facility is not among them, you may get a call soon!
Increase the AVF rate. The CMS target of 48.9% for NW #14 (Texas) was not achieved and the target will increase again for the next year. For more information on Fistula First see page 7 in this newsletter.
Reverse the increase in Involuntary Patient Discharge seen in 2007.
Continue to improve EMSystem compliance.

As always, we appreciate all that you do to deliver quality care to the ESRD patients in Texas.

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E-Mail is NOT Secure

The Centers for Medicaid and Medicare Services (CMS) has informed Networks that they are not allowed to receive emails that contain PHI (patient health information like name, SSN, dates of services, etc.) Email communications are not secure and sending PHI in an email is a violation of the HIPAA regulations protecting patient confidentiality. CMS's Security Policy requires Networks to report anyone that sends PHI to us via email. “First offender” clinics will receive a warning letter from NW #14 informing them that one of their staff members sent an email to the Network containing PHI and that additional “violations” (NW receipt of emails containing PHI) would result in the clinic being reported to HIPAA.

Listed below are Network e-mail communications that can accidentally include PHI. We recommend you review this memo with your QI team and all facility staff (especially your Social Worker, Data Contact, Anemia Manager and Fistula First coordinators) so your facility won't be a “HIPAA Offender”.

Patient Activity Report:

Do NOT e-mail your monthly Patient Activity Report (PAR) to the Network.
The PAR can be mailed or faxed to the Network.
For security reasons, facilities should make sure they are faxing to the correct fax number and that the fax is received by the Network.

Fistula First Data Reports:

Do NOT e-mail Fistula First Reports containing patient names.
You can email your Fistula First Report if you email ONLY the Facility Summary tab of the worksheet tool, which does not contain patient names.
Send Please call Gay at the Network for help if you are having problems.

Email Inquiries or Responses to NW Questions:

Do NOT send email inquiries or responses to the NW that include the name or SSN of a patient. If you must speak to a staff member about a specific patient, please call – don't email.

Thank you for working with us to safeguard the personal information of the patients we are charged with serving.

Developed by Network #8, Adapted and Distributed by Network #14

IMMEDIATE JEOPARDY – Disabling Air Detectors!

According to the CMS Conditions for Coverage and the DSHS ESRD Licensure Rules definitions, if staff are performing clinical practices that directly threaten the health and safety of the patients, this constitutes “Immediate Jeopardy” for the facility's patients.

The Network was informed by Texas DSHS surveyors that during recent ESRD facility surveys, surveyors observed direct patient care staff initiating and trouble shooting dialysis treatments with the bloodline out of the air detector clamp OR with a disabled air detector.

Once the bloodlines are connected to the vascular access AND before the blood pump is turned on, the air detector must be fully activated and all bloodlines must be correctly positioned in the air detector clamp.

It is never “OK” to remove the bloodline from the air detector clamp while the patient is connected to the hemodialysis machine, even during machine alarm troubleshooting!

If any manipulation or troubleshooting must be done that requires the air detector clamp to be continually reset or disabled, then the patient must be disconnected from the bloodlines and the system put into recirculation until the problem is corrected. The patient should never be connected to the bloodlines if the bloodline is out of the air detector clamp. The entire reason for the air detector and the bloodline clamp is to prevent accidental air embolism.

Remember – Patient Safety is Your First Priority!

EXTRA! EXTRA! READ ALL ABOUT IT!

Take a look at the final 2007 CPM Project results (4th quarter 2006 data) below to find out how NW #14 compare to facilities in the other 17 ESRD Networks. View slides showing comparison of NW #14 data to the other ESRD Networks.

CPM Data – Hemodialysis:

% Patients with mean spKt/V > 1.2 - 95% (1st Place)
% Patients with mean URR > 65% - 91% (Tied -1st Place)
% Patients with mean Hgb > 11 g/dL – 87% (Triple Tie -1st Place)
% Patients with mean Hgb < 10 g/dL – 4% (4 way tie - 2nd Place)
% Patients with mean TSAT > 20% - 82% (4 way tie - 2nd Place)
% Patients with mean Ferritin > 100 ng/mL – 97% (1st Place)
% Patients with mean serum Albumin > 4.0 g/dL – 38% (Tied - 5th Place)
% Patients with mean serum Albumin > 3.5 g/dL – 84% (4 Way Tie - 4th Place)
% Patients with adjusted Calcium 8.4 – 10.2 mg/dL – 83% (3 way tie- LAST Place)
% Patients with mean phosphorous 3.5 – 5.5 mg/dL – 50% (2nd to LAST Place)

CPM Data - Vascular Access

% of Prevalent Patients with AVF – 42% (10th Place)
% Incident Patients with AVF – 44% (5th Place)
% Prevalent Patients with Graft Only - 32% (Last Place – Highest AVG rate in U.S.)
% of Patients with AVG and Stenosis Monitoring – 72% (Triple tie for 5th Place)
- Not only does Texas have the highest AVG rate in the country, we only rank 5th highest in the country in performing stenosis monitoring of our AVG's!
% Prevalent Patients with Catheters – 24% (4th Place – 4th lowest catheter rate in U.S.)
% Prevalent Patients with catheter > 90 days – 18% (Tied for 3rd Place)
- Texas has the 3rd lowest rate in the U.S. for catheters > 90 days!)

CPM Data - Peritoneal Dialysis: Final PD CPM data has yet to be released. We will share the PD data with you as soon as it is available.

CMS “Revisits User Fees”

Last fall, it was announced that CMS had issued a new rule, mandating that all facilities participating in the Medicare program (including dialysis facilities) would be charged a “revisit user fee” when a follow-up survey was performed. This rule became effective September 19, 2007, the day of publication.

Beginning December 26, 2007, CMS is no longer charging for survey follow-up visits, as it was determined that the fiscal year 2008 Omnibus Appropriations Bill did not reauthorize the program. Therefore, revisit surveys conducted on or after December 26, 2007 will not be subject to a revisit fee. Follow-up visits that took place between September 19, 2007 and December 26, 2007 may, however, be subject to this fee.

Exsanguination: the action or process of draining or losing blood (Merriam-Webster)

Several months ago, an article in the Baltimore Sun highlighted the number of Maryland dialysis patient deaths due to exsanguination. As the article details, the Maryland medical examiner's office concern over 24 exsanguination-related deaths from 2000-2006 prompted the issuance of advisories to dialysis facilities encouraging patient education on vascular access care.

In follow-up to the Maryland probe, we analyzed the number of patient deaths in Network 14 that were attributed to exsanguination – resulting from hemorrhage from vascular access, ruptured vascular access aneurysm or blood loss via the dialysis circuit. To our dismay, the numbers, while only a fraction of total patient deaths, were much higher than we would have suspected.

For the years 2001-2006, there were 330 patient deaths attributable to exsanguination: 91 were attributed to hemorrhage from vascular access; 74 were attributed to rupture of vascular access aneurysm; 1 related to blood loss via the dialysis circuit and 164 attributed to other causes. Numbers of deaths caused by exsanguination per year in Network #14 are noted below.

Year	Deaths caused by exsanguination	Percent of Total Deaths
2002	38	0.7%
2003	35	0.7%
2004	55	1%
2005	45	0.8%
2006	57	0.9%
2007	60	1%

As is readily apparent, these numbers have not improved over the past six years and it is every facility's responsibility to seriously scrutinize practice patterns to identify potential changes that could improve patient survival outcomes. To safeguard the lives of your patients, please review the practice pattern recommendations below and discuss them in your QI and staff meetings. Remember – exsanguination events are accidental and can be prevented if staff follow these basic patient safety practice pattern recommendations.

Facilities should ensure:

Vascular accesses (including catheters) are assessed by licensed personnel each and every treatment. The Nephrologist should routinely evaluate accesses with notable aneurysms or pseudo-aneurysms and refer to surgeon as needed.
Vascular accesses are uncovered and visible during treatment UNLESS this presents a greater likelihood of blood loss, as may be the case with pediatric or confused/demented adult patients. There may be times when an access that is securely taped is better left “out of sight, out of mind”. In this instance, be sure that facility policy addresses this and that a physician's order has been obtained for such.
All connections to the dialysis circuit are securely Luer-locked. If non-Luer connections are in use, check to make sure connections are securely taped to prevent accidental disconnection.
Dialysis machine alarms are functioning properly prior to each dialysis treatment.
Venous pressure alarms are set narrowly to allow the alarm to respond rapidly to significant pressure changes.
Venous pressure alarms are never be silenced without first investigating the cause of the alarm.
During initiation of dialysis, if a patient's arterial needle is connected to the vascular access and the blood pump is turned on while the venous return line is put into a container to collect the priming saline (rather than connected to the venous needle), it is critical that the staff member focus solely on this task. In fact, it is recommended that the staff member physically hold the venous line from the time the pump is started until the time the venous line is connected to the venous needle.
If this practice is common in your unit, please ensure that the policy and procedure addresses safety issues to prevent accidental exsanguination.
Scissors or other sharp objects are never used near hemodialysis catheters! While this seems to be common sense, there are documented reports of both staff AND patients severing catheter tubings, some of which have resulted in death.
ALL facility staff, including non-direct patient care staff such as dieticians and social workers, have been instructed and are fully aware of facility policy regarding vascular access monitoring and care.
You teach your patients and their family members how to care for their dialysis access, including emergency care for bleeding. Specifically, teach patients what “prolonged” bleeding is (according your facility policy) and what actions the patient/family members should take if his/her access has “prolonged” bleeding. Even after patients are educated on how to care for a bleeding vascular access - repeat, repeat, and repeat the information until patients and/or family members are able to not only repeat the information without hesitation or error, but are able to demonstrate to you the actions they would take if their access started to bleed after they left dialysis, or if their vascular access was cut by a sharp object.

References

Developed by Network # 8, Adapted and Distributed by Network # 14

Follow Up from the Recent End-Stage Renal Disease Open Door Forum

CMS is offering members of the End-Stage Renal Disease (ESRD) provider community and other ESRD stakeholders a venue to submit questions about the newly published ESRD Conditions for Coverage (CfCs). The goal is to provide responses that will help inquirers understand the new requirements. CMS is requesting that members of the ESRD renal community submit questions pertaining to the ESRD CfCs to the CMS ESRD_Final_Rule_Rollout mailbox at ESRD_Final_Rule_Rollout@cms.hhs.gov beginning May 12, 2008. Please submit only questions that pertain to the CfCs, as CMS will only answer these questions, and on a rolling basis. CMS will also try to communicate the questions and answers in the most efficient manner back to stakeholders. Their goal is to be as timely as possible with responses, but they cannot commit to a prescribed schedule.

Questions pertaining to ESRD payment, claims processing, Network activity, and survey and certification issues should be directed to your usual contact within CMS. Please contact Lynn Riley at 410-786-1286 or Lauren Oviatt at 410-786-4683 with questions about this announcement.

As Network 14 nears the end of the CMS contract year, CMS will be evaluating our performance in improving vascular access outcomes. With a prevalent AVF rate of 48.2% for February 2008, we are still a couple of “steps” away from achieving the CMS-assigned goal of 48.9% of prevalent patients using an AVF for HD access. 0.7 percentage points may not seem like much of a gap, but we realize how much work it takes on everyone's part to increase the network's prevalent rate by even 0.1%.

We thank all for working so diligently to improve vascular access care for your patients!

Total Catheter Rate (includes all catheters): As of December 2007, the total catheter rate for NW #14 prevalent patients remains stable at 22.0%. The percent of patients using a catheter only > 90 days also remained stable and relatively unchanged with NW #14 facilities reporting 8.4% of prevalent patients using a catheter only > 90 days.
Catheter Placement in Incident Patients: This is the vascular access practice in greatest need of improvement in our Network.
- In December 2007, NW #14 facilities were reporting incident catheter rates of 67.6% for new patients, an increase from October 2003 (49.5%).
- The MRB recognizes that there are a number of variables – financial, patient choice, access to care – that negatively impact permanent access placement in incident patients.
- Incident access placement work is also not in the “facility's hands”; it occurs before dialysis is initiated and the impetus for change lies in the hands of primary care physicians, nephrologists, physician extenders and surgeons.
- To “shine a light” on catheter placement in incident patients, nephrologist-specific reports comparing the length of the time a physician's incident patients were seen by a nephrologist will be graphed against the incident AVF placement rates in these patients. In similar studies done in other Networks, 50-70% of incident patients seen by a nephrologist prior to initiating HD started dialysis with a catheter only. These reports will be sent to nephrologists this summer.
“Sleeves Up Protocol” for Assessing Failing AVG for Conversion to Secondary AVF Another vascular access practice that will be receiving more focus during the next year is the assessment of failing AVGs for possible conversion to secondary AVFs, also known as the “Sleeves-Up Protocol”. More information and practice tools for assessing failing AVGs and planning for secondary AVF placement will be coming your way this summer!

Developed by ESRD Network #8 & Adapted/Distributed by ESRD Network #14

Be on the “Lookout” for these Network Quality Activities!

JUNE

Fistula First Facility Specific Data and Texas Comparative Data Charts mailed to Network #14 Hemodialysis facilities.
2008 Clinical Performance Measures (CPM) Data Collection forms sent to a random sampling of adult hemodialysis and peritoneal dialysis facilities, and 100% of the pediatric and Veterans Health Administration facilities.
NW QI Staff will be reviewing progress with facilities that submitted:
- 2007 Vascular Access Improvement Plan (VAIP).
- 2007 Improvement Plans for a Quality of Care (QOC) Concern.

AUGUST

2008 Dialysis Facility Report (DFR) will be mailed to all facilities.

New Texas ESRD Facilities

The End Stage Renal Disease Network of Texas is please to welcome the following new Medicare dialysis facilities. You may access a complete listing with addresses, telephone and fax numbers, and provider numbers from our website at www.esrdnetwork.org. Go to Provider Directory > Dialysis Facility > On right hand side of webpage > “Dialysis and Transplant facilities”.

Provider Number	Facility Name
67-2574	FMC - Rowlett Rowlett, TX 214-703-6951
67-2575	Ft. Worth Dialysis Ft. Worth, TX 817-886-3200
67-2576	FMC – Cedar Park Cedar Park, TX 512-259-1329
67-2577	RSA – Shertz Shertz, TX 210-659-6070
67-2578	Boerne Dialysis Ctr. Boerne, TX 830-249-1491
67-2579	Mid Cities Dialysis Center Hurst, TX 817-656-2843
67-2580	Lake Cliff Dialysis Ctr. Dallas, TX 214-942-7727
67-2581	The Woodlands Dialysis The Woodlands, TX 281-292-6788
67-2582	Purificare Dialysis, LLC Arlington, TX 817-394-1863
67-2583	Med Center at Home Houston, TX 713-790-0150
67-2584	FMC – Falfurrias Falfurrias, TX 361-325-3528
67-2585	The Dialysis Cottage Gainesville, TX 940-612-8800
67-2586	FMC – Saratoga Corpus Christi, TX 361-986-0163
67-2587	FMC – N. Garland Garland, TX 214-703-0564
67-2589	Liberty Dialysis – Mesquite Mesquite, TX 972-285-8207

For more information on opening a facility, please visit our website at www.esrdnetwork.org. Go to Provider Directory > Information for Providers > Opening Instructions for a New Facility > New Facility Welcome Packet and Forms. Compete and fax to 972-503-3219. Make sure to allow 6 to 8 weeks for processing.

ESRD Network # 14 (or ESRD Network-Facilitated) Data Collection Projects

We understand that it can be difficult for facilities to keep track of the various data submissions they are required to send to the ESRD Network. To help you understand our data collection projects, we developed a “Quick Reference” that lists the forms, when the data is collected, what type of data is collected, and who needs to complete and send in the particular forms. Please print and keep a copy of this handy guide to help you keep track of the required ESRD and CMS data collections. If you need more information or have questions, please call Angie Wieler at (469) 916-3806.

NW QI Department to Require More Timely Submission of Facility Data

The Network QI Department will be requiring more timely submission of facility data. We anticipate that the stricter requirements will not affect many facilities as the majority of our facilities are very prompt in the submission of data, and we commend you for your diligence. However, we wanted you to be aware that CMS is putting increased emphasis on timely submission of data by facilities.

To comply with CMS requirements, the Network will not be able to be as flexible as in the past in extending deadlines for data submission. Failure to submit data in a timely manner will result in facilities being referred to DSHS for survey, based on facility non-compliance with Network Goals and Objectives. Here are some helpful hints to avoid missing deadlines for data submission:

Be sure that mail from the Network is delivered promptly to the person whose name or title is listed on the label.
Be sure to note the due date on the fluorescent label on the front of the envelope on all mail sent from the Network requiring timely submission of data.
Open mail from the Network promptly and distribute contents per the cover sheets.
Read the letter and instructions included in the mailing to determine how much time will be required to collect and submit the required information in a timely manner. Then plan your time accordingly.

We understand the many demands on your time, and we thank you for working with us to achieve more timely submission of data.

NEW Federal Rules and Regulations are PUBLISHED!!

The Centers for Medicare & Medicaid Services (CMS) formally PUBLISHED the new CMS Conditions for Coverage (COC) on April 15, 2008. The COC are the Federal Rules and Regulations governing End Stage Renal Disease (ESRD) facilities in the United States.

To access the Final Conditions for Coverage and related documents, please go to our web site at www.esrdnetwork.org and look on the right side of the home page for 2008 CMS Conditions for Coverage.

To read or download/print the condensed 116-page document, click on Final ESRD Rules link.
To read or print the official CMS press release on the COC, click on CMS Press Release April 3, 2008 link.
To view the CMS Conditions for Coverage slide presentation that debuted at the 2008 National Kidney Foundation Clinical Meeting and the 2008 ANNA National Meeting, click on CMS Slide Presentation-Final Rules link.

Following are highlights of changes to the New Regulations, as presented by Glenda Payne and Judith Kari:

Effective Dates for the New Rules
1. New Conditions for Coverage - October 14, 2008
2. Life Safety Code and Separate room for HbsAg+ patients - February 9, 2009
3. Certification of technicians hired after 10-4-08 - 18 months from hire date
4. Certification of existing technicians – April 15, 2010
Infection Control
1. Encompasses an entire Condition
2. Uses CDC published recommendations
3. All New facilities must have an isolation room or receive a waiver from CMS
Water & Dialysate
1. Use of AAMI RD52:2004 as regulation
2. Reuse – AAMI RD:47:2002/2003 as regulation
Physical Environment
1. Implementation of the Life Safety Code
2. Facilities built after 1/1/2008 must meet NFPA 2000
3. All facilities must have an AED OR a defibrillator & ACLS qualified staff
Patient's Rights
1. Must receive information on all modalities
2. Informed regarding advance directive
3. Informed about transfer & discharge policies
4. Receive alternate scheduling options
5. Receive necessary services listed in Plan of Care
Patient Assessment
1. Comprehensive
2. Interdisciplinary Team
3. Initial completed within latter of 30 days or 13 HD treatments
4. Specific required components detailed in Regulations
5. FYI: ANNA/NKF have developed a tool
6. Comprehensive reassessment must be done 3 months following initial assessment
7. Adequacy must be assessed Monthly for HD and every 4 months for PD
8. Stable patients require an annual review
9. Unstable patients require reassessment monthly
Plan of Care
1. These must be completely individualized!
2. Initial due the same as the Patient Assessment – 30 days or 13 HD treatments
3. Update must be done within 15 days of each reassessment
4. No Long Term Care Plans required!
Care at Home
1. Separate condition for home therapies
QAPI (Quality Assessment and Performance Improvement)
1. Inadequate QAPI activity will be a condition level
2. Must include interdisciplinary team
3. Must be continuous and on-going
4. Must be outcome focused
5. Must close the loop on the issues (Plan-Do-Check-Act – PDCA)
Personnel
1. The regulations define qualifications for the various positions
2. Technicians must be certified by a national organization (time frames are outlined above). The three approved external certification organizations are:
  1. Nephrology Nursing Certification Commission (NNCC)
  2. The Board of Nephrology Examiners Nursing and Technology (BONENT)
  3. National Nephrology Certification Organization (NNCO)
Medical Director
1. Increased accountability for clinical outcomes, facility operations, facility processes/procedures, staff training
Governance
1. RN “is present at all times that in-center dialysis patients are being treated”
2. Patient Involuntary Discharge
  1. Facility directed to reassess the patient prior to involuntary discharge
  2. Medical Director must be involved in involuntary discharge decision
  3. Contact another facility and attempt to place patient
  4. 30 days notice, unless threat to safety
  5. Notify the Network and the State Agency
Electronic Data Submission
1. “As of 2/1/2009, every facility must electronically submit data on all patients, including data on clinical performance measures, to CMS.”

Although this list does not include all of the new changes, it does address many of the areas that will require changes in policies of the facilities and planning for implementation. Further information will be disseminated as available.

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Thank you, Thank you, Thank you

The Texas dialysis community experienced unprecedented facility closures during the first 6 months of 2008 that necessitated placement of hundreds of patients on very short notice. The facilities along with the Network and the Texas Department of State Health Services reached out to area clinics seeking placement for the patients. We are so PROUD of the dialysis community in these areas who went beyond the call of duty and stepped forward to help in these crisis situations. The Network would like to recognize the following clinics:

Bayou City
Beaumont Kidney Ctr.
Beaumont South
CyFair Dialysis
DaVita – Livingston
DaVita – Longview
Deerbrook Dialysis
DCI – Nacogdoches
FMC – Nacogdoches
North Star Dialysis
FMC- Golden Triangle
Henderson Kidney Center
Innovative Renal Solutions
Kidney Ctr. Jasper
Nacogdoches Memorial
North Shepherd
North Houston Dialysis
RCG – Center
RCG – Crockett
Renal Solutions
River Park Dialysis
Woodville Dialysis

Also a great big THANK YOU to those units who responded to our call for help but did not receive any of the displaced patients.

We would like to apologize to any individual or clinic that we may have inadvertently missed mentioning in this article that provided assistance to the Network, DSHS, and the displaced patients.

THANKS FOR THE SUPPORT.......!

We appreciate your comments and suggestions to bring you information and tools that you need.

Please email gbrown@nw14.esrd.net to make suggestions, comments or corrections.

Or if you wish to be removed from or added to this distribution list, please let us know.

This newsletter is published by the ESRD Network of Texas, Inc. #14 under contract #HHS-500-2006-NW014C with The Centers for Medicare & Medicaid Services (CMS).