Interpretive Guidelines by nikeborome


									Meeting The Fluid Management
   Conditions of Coverage
 Thru Crit-Line Monitor Use

Diana Hlebovy RN, BSN, CHN,
  Director of Clinical Affairs
        Hema Metrics
• Discuss the rationale for adding fluid
  management into the Conditions of Coverage

• Review the long-term complications of HD
  related to FVE and FVD

• State the conditions and interpretive
  guidelines related to fluid management

• Verbalize the CLM as the Gold Standard of
  fluid management to meet the CfC
Conditions of Coverage: Community
• Volume mismanagement is the main cause for cardiac
  related morbidity and mortality rates
• Not referring to it was a “Serious Omission” that needed
  to be corrected.
• Fluid management cited as the current “Orphan in
  Quality Assessment”.
• It is the “Single Most important indicator” related to
  morbidity and mortality
• Without managing volume and its effects on the heart,
  there would be no patients.
  Conditions of Coverage
Patients must be assessed for the
appropriateness of the dialysis
prescription, blood pressure and fluid
management at §494.80(a)(2), which
encompasses intradialytic symptoms
and issues, such as cramping, as well
as dialysis adequacy.
     Conditions of Coverage:
      Community Comments
• CMS received several comments
  regarding §494.90(a)(1), “Dose of

• Some commenters suggested we
  include patient volume status (
  measurement of body fluid removal) in
  the adequacy requirement
      Conditions of Coverage:
       Community Comments
• Kt/V levels did not correlate with mortality
  or morbidity

• Dialysis adequacy monitoring needs to be
  modified to require facilities to “monitor
  fluid status.”

• Better methods of measuring intravascular
  volume and related blood pressure changes
  are needed
      Conditions of Coverage
• Volume control, important to blood pressure
  management and cardiac health, is an essential
  component of dialysis care that requires ongoing
  attention from the care team.

• Therefore, we are incorporating it into the “dose of
  dialysis” plan of care element.

• Under the “Patient plan of care” condition, we have
  modified §494.90(a)(1) to read, “The
  interdisciplinary team must provide the necessary
  care and services to manage the patient’s volume
        “Protect the Pump ”

The principal goal of these conditions is
to improve cardiovascular outcomes by
  optimizing fluid management practices
  and strategies during hemodialysis
               “Protect the Pump ”

Fluid Management is a

     -   High Risk
     -   High Volume
     -   Problem Prone
     -   High Cost

     Aspect of Care that must be clearly included in the
     Quality Assessment and Performance Improvement
               “Protect the Pump”

 Optimal Fluid Management strategies need to
 be implemented to provide:
The right care for every person, every treatment,
 every time
 Fluid management Strategies need to be:
   •   Safe
   •   Effective
   •   Efficient
   •   Patient-centered / Individualized care
   •   Timely
   •   Equitable
“Protect the Pump”

  Current Trends
              Current Trend :Safe
Occurrence of Intradialytic Morbidities (Ischemic events) during HD :

                     • Hypotension up to 50%

                        • Hypoxemia 50%

                         • Cramping 20%

                     • Nausea/ vomiting 15%

                       • Seizures up to 10%

                           • Angina 5%

                  • Myocardial Ischemia 22% TXs

                 • Dysrhythmias 50% of patients

                  • Cardiac arrest 7/100,000 TX

        • Sudden death 25% of all deaths in HD population
               Effects of
       Intradialytic Hypotension
•   Tissue Ischemia / Hypoxia
•   Adenosine release causing decrease in PVR
•   Changes in Mental status / Seizures / Stroke
•   Vision changes
•   Silent cardiac ischemia / MI
•   Ischemia / Infarct to the gut
•   Decrease in Residual Renal Function
•   Ischemia = decrease in URR
                “Protect the Pump”

Change concepts:
Medical injuries and medical errors: V634(vi)‫‏‬

   “ Occurrences such as treatment prescription errors,
   intradialytic morbidities (IDMs) ….should be identified,
   reviewed and trended.

    “Intradialytic morbidities” is any adverse symptom that
   occurs during the dialysis treatment to include but not be
   limited to seizures, chest pain, hypotension and cardiac
     V640 : Patient Safety

The facility must immediately correct
any identified problems that threaten
the health and safety of patients.
          Current Trend: Effective
                  • Mortality rate remains >20%

           • Average ESRD Treatment Life is 62 months

                     • CVD accounts for 50%
                • >90% of patients are hypertensive

             • 70% have Left Ventricular hypertrophy
             • CHF was found in 40% of ESRD patients

           • 60% remain in fluid volume excess post TX

• Two or more hypotensive episodes per week increase the death rate
                              by 70%
          • Residual Kidney function decreases with IDMs

           • Hemoglobin “Time in range” remains difficult to maintain
                “Protect the Pump”

Change concepts:

•   Hemodialysis is a remarkable cardiac stressor

•   Critical thinking needs to be put back into Dialysis

•   Treatment records must reflect attaining target weight
     (V543 Dose of Dialysis)‫‏‬
      Current Trend: Efficient
• Average BP meds 3 ( 5 not uncommon)‫‏‬

• CVD is a major cause of hospital admissions for patients on
  hemodialysis, accounting for 49% of chronic and 40% of acute

• Pulmonary edema being the most common admitting diagnosis

• Extra treatments for Fluid removal - UF only continue

• IDMs are considered an acceptable/ expected side effect

• Recovery time following typical HD is >1 day
    The Dry Weight Issue
Prevalence of Patients on Antihypertensives

  1970              10%
  1997              75%
  2002              80-90%

   Cary, 2002
                “Protect the Pump”

Change concepts: V543 Dose of Dialysis
  The ultrafiltration component of the hemodialysis
  prescription should be optimized with a goal to render the
  patient euvolemic and normotensive.
  A patient at their EDW attains normotension for most of the
  interdialytic period, while avoiding orthostatic hypotension
  or postural symptoms either during or after dialysis.
  With successful fluid management, the number of
  medications a patient needs for blood pressure control may
  be able to be reduced.
    Quotes from Dr Charra
• “Need to Focus on Dry Weight”

• “Dropped the Ball with failure to
  Achieve and maintenance Dry

• “Control of Dry Weight = Control BP =
  Increase in Survival Rate”
Current Trend: Patient Centered
• UF Goal set by comparing pre-weight to EDW

• EDW generally incorrect

• UFRs exceed recommended 10ml/kg/ hr

• Plasma refill rates are different on different days depending on
  numerous patient variables

• UF Profiles are not individualized for each TX

• Standard 2 gram sodium diet still prevalent

• Facility Standard Dialysis bath / temperature

• Sodium modeling remains on the majority of patients
 To avoid thirst, fluid gains and
hypertension, the NKF-KDOQI Clinical
Practice Guidelines state that increasing
positive sodium balance by “sodium
profiling” or using a high dialysate
concentration should be avoided.
               “Protect the Pump”

Change concepts: 494.80 Condition: Patient
    assessment: V503: : Appropriateness of Dialysis

•   The patient record should show evidence that the
    patient's individual dialysis needs have been assessed
    and the current dialysis prescription evaluated as to
    whether it is meeting those needs.

•   “Individualized” means each assessment is unique to a
    particular patient and addresses that patient’s
        Current Trend: Patient
• Oxygen needs are rarely assessed

• Root causes for IDMs rarely assessed

• TX of IDMs consist of stopping UFR/ Normal saline/ Position

• Staff feel they are doing “all they can do”

• Patients are labeled “noncompliant” if fluid gains are

• Patients are blamed for the cause of crashing

• Staff/ Patients believe that if they “crash” they have reached
  their EDW
Three Compartment Model Fluid Shifts

         Space          Extra-         Circulating
                        cellular      Blood Volume

              Toxins         Toxins

              Fluid          Fluid

        23 Liters      17 Liters       5 Liters
 Dialysis Assessment

Just because a patient “Crashes”
            It does NOT
       Mean they are “DRY”!!!
                “Protect the Pump ”

Change concepts:

•   It is unacceptable for a patient to feel bad during or
    after the hemodialysis related to the dialysis process

•   Efforts to improve the patients experience while
    receiving hemodialysis services need to be promoted

•   Hemodialysis (HD) treatments need to be personalized
    and individualized: no cookie cutter dialysis!
    V559: Adjusting the plan of
This requirement is not met/ not satisfied if:

• The patient's plan of care is not adjusted /

• There is no evidence the IDT is working to address
  ongoing problems (e.g., uncontrolled hypertension,
  hyperkalemia, missed treatments, inaccurate or
  unattainable target weight

• The only reason documented for failure to achieve
  goal(s) is “patient non-compliance” or “non-
       Current Trend: Timely
• Treatment of IDMs are reactive vs.

• EDW is changed after event or admission for

• UFR generally exceed plasma refill rate
  causing IDMs

• Number one cause of getting off early /
  skipping TX is IDMs or fear of them
    Current Trend: Equitable
• Hospital days remain high:
 - 2 admissions; 14 days per patient per year
 - CV causes are increasing by 10%
 - Time in range effects the Relative Risk

• Extra normal saline, hypertonic, mannitol. Albumin,
  oral medications given for treatment and prevention
  on IDMs

• Patient are still receiving extra treatments for fluid

• Medicare budget is significantly impacted
                 “Protect the Pump ”

Change concepts:). V520 Standard: Patient reassessment
  Monthly reassessment of unstable patients which includes
  inadequate dialysis

  Inadequate dialysis also include symptoms related to fluid
  management such as:
  •Volume overload or depletion
  •Intradialytic symptoms such as syncope or congestive heart failure
  •Need for extra treatment for fluid removal
  •Sudden onset of cardiac arrhythmias
                  “Protect the Pump ”

Change Concepts:

•   The goal of ultrafiltration is to obtain normovolemia
    and normotension without Intradialytic morbidities

•   This along with solute clearances comprises adequacy
    of dialysis
           Dose of dialysis
Defines EDW- and the inter/ intradialytic
 measures that will be used to evaluate the

• A patient at their EDW should be:
    - asymptomatic and
    - normotensive
    - on minimum blood pressure medications
    - while preserving organ perfusion and
    - maintaining existing residual renal
              “Protect the Pump”

    Clinical Performance Measures (CPMs) for fluid
    management ( attaining Dry Weight) may include:

•   Pre/ Post/ lowest BP
•   Number of BP medications
•   Hospitalizations related to fluid management
•   Intra/ interdialytic morbidities
•   Cardiac arrest, sudden death
•   Reassessment of residual kidney function (RKF)‫‏‬
•   Dry Weight (plasma refill) checks if BVM available
       QAPI: Measurement
     Assessment Tool (MAT)‫‏‬
• V543 Dose of Dialysis:
    Management of volume status

• Value monitored:
       Euvolemic and Normotensive
           - BP 130/80 (adult)‫‏‬
       - Lower of 90% of normal for
               age/ht/wt or
             130/80 (pediatric)‫‏‬
         Learning from “history”
•   Clyde Shields
•   First long-term HD patient in the US, March 1960
•   Developed malignant HTN within a few months
•   Treatment: aggressive ultrafiltration (UF)‫‏‬
•   Three times per week HD – 8-10 hours each
•   Result: 11 years of dialysis in the 1960s

• “The key to treating HTN in dialysis
    patients is adequate control of the
    extracellular volume”. AJKD;6:511-519,1990
                    Scribner BH:
The new conditions of coverage
elevate the importance of fluid
management effects on:

       • Anemia (V507; V547)‫‏‬
   • Nutritional status(V509; V545)‫‏‬
      • Access patency(V 551)‫‏‬
       494.140 Condition:
  Personnel qualifications.V681
Staff education is now mandated to
specific competencies such as :

• Identifying and treating intradialytic
• Monitoring patients
• Equipment alarms
    Crit-Line Monitor:
  The Gold Standard of
Optimal Fluid Management
Crit-Line’s Clinical Impact in Fluid Management

 Clinical Studies compiled over 5 years have documented:
       70% Reduction in Intradialytic Morbidity
 (i.e. “CRASHING”)‫‏‬

       50% Reduction in Anti-hypertensive medications

       48% Reduction in Hospitalizations due to Fluid

       > 45% Reduction in Hospitalizations due to
               Access Complications (See Howard, et al.)‫‏‬
       55% Reduction in Left Ventricular Hypertrophy
Meeting the new Conditions of
Coverage with
the Crit-Line Monitor (CLM):
         Protect the Pump

CLM IMPACTS: Hypotension,
Hypertension, CHF, Myocardial
Infarction, Organ Ischemia Stroke,
Sudden Death

Quality of Life Costs   Financial Costs
 Quality of Life Costs               Financial Costs
Patient Recovery Time, AMA’s,   Hospitalizations/Hospital Days
    Rehabilitation Potential
                                Medications/IV Solutions to TX
                                Medications to TX Hypertnesion

                OUTCOME MEASURES
  BP’s (Hi/Low/Medications), Dry Weight/ECV/TBW,
 Residual Renal Function, Inter/Intradialytic Symptoms,
  Sudden Death, Left Ventricular Mass Index (Echo),
                Hemoglobin Variability
        End – Section 1
Thank you for taking time to learn
about the new CMS Conditions of
Coverage as they relate to fluid
management. To learn how the Crit-
Line Monitor can help you meet these
new conditions, please select Section 2
of this presentation.
       Additional Information
• Please call 1-800-546-5463 if you would
  like additional information or would be
  interested in evaluating Crit-Line at your
• Additional information can also be found at
              Section 2
Crit-Line Monitor a tool for compliance
     with Conditions of Coverage.

Thank you for taking time to learn
about the new CMS Conditions of
Coverage as they relate to fluid
management. In this section, you will
learn how the Crit-Line Monitor can
help you comply with these new
Multi-parameter Platform
FDA 510k Approved CRIT-LINE Parameters
                                      Blood Flow

• Hematocrit (HCT)‫‏‬                  Blood
•   O2 Saturation (SAT)‫‏‬

•   Change in Blood Volume ( BV)‫‏‬

                                     Emitter   Detecto
Fundamental Parameter: Hematocrit (Hct)‫‏‬

                           Test tube represents
                           circulating blood volume

  Total Blood                                  RCV
  Volume (BV)‫‏‬                         Hct =
                            Red Cell

      RCV      (Test tube represents
HCT =          circulating blood volume)‫‏‬

Total Blood
Volume (BV)‫‏‬
                 Red Cell Volume
Hematocrit and Blood Volume


                                   RCV             27
                0            Hct =     X 100
%BV (Loss)‫‏‬

                     0   1       2       3     4
                                HYPOXEMIA DURING HEMODIALYSIS

                                  TISSUE ISCHEMIA
                                  TISSUE ISCHEMIA
                                   TISSUE ISCHEMIA

                        Releases adenosine
                         Releases adenosine

                                                   Blocks the release of
                                                    Blocks the release of

                                               norepinephrine                   from
   This tissue
     This tissue
 ischemia effect
    ischemia effect
maybe the reason
                                               sympathetic                  nerve
  maybe the reason
   that anemic
     that anemic
patients are prone
   patients are prone
 to hypotension.
    to hypotension.
Types of Hypoxia:               Causes in

        • Hypoxemic Hypoxia     Fluid excess
                                   Sleep Apnea

        • Anemic Hypoxia         Anemia (Hgb
          ≤ 10)‫‏‬

        • Circulatory Hypoxia   Cardiac

           Factors to Consider:

    Arterial Blood: Internal Access ( Fistula

• Mixed Venous Blood: CVC line

• 90 to 100% is considered normal for arterial sats

•   60 to 80% for mixed venous sats (SvO2)‫‏‬
Complimentary Oxygen Delivery Issues
                       02 Delivery   20+ % of HD patients have intradialytic
                        hypoxemia and up to 70% are sleep apneics.

                                     Sleep Apnea Profile
   Oxygen Saturation


                        85                    Sleep

                             0       1           2           3           4
                                          Time (hours)‫‏‬
       Access: Catheter

                   Venous Blood
                Lower O2 Saturation
      Factors to Consider:

The continuous monitoring of SvO2
 is a sensitive Parameter of continuous
Cardiac Output

 C. O. = Heart Rate x Stroke Volume
Seizure 1 hour 55 min into TX
The Guyton Curve
Blood Volume (liters)‫‏‬




                         1                                                     Adapted from Guyton, AC:
                                                               Textbook of Medical Physiology, 1991, pg.324
                             0   5           10       15        20        25         30         35            40

                                                       Extracellular Fluid Volume (liters)‫‏‬
Three Compartment Model Fluid Shifts

         Space          Extra-         Circulating
                        cellular      Blood Volume

              Toxins         Toxins

              Fluid          Fluid

        23 Liters      17 Liters       5 Liters

Blood Volume (liters)‫‏‬
                         5                  Normal
                                                                  Adapted from Guyton, AC:
                                                Textbook of Medical Physiology, 1991, pg.324
                             0   5        10      15      20      25       30      35       40
                                          Extracellular Fluid Volume (liters)‫‏‬



                             TIME 03:25       HCT 31.2          BV 0.2          SAT 98



      1   2            3   4   5

          Time (hr)‫‏‬

Blood Volume (liters)‫‏‬
                         6                                     B
                         5                           Normal

                         1                                                          Adapted from Guyton, AC:
                                                                   Textbook of Medical Physiology, 1991, pg.324
                                 0      5       10         15        20       25        30          35        40
                                                     Extracellular Fluid Volume (liters)‫‏‬



                                 TIME 03:25      HCT 34.7                BV -17.3            SAT 94
              Dose of Dialysis
  Evidence of implementation of the
  plan of care for this aspect would
• Treatment records reflecting attaining the target
  weight at the end of each treatment
• Documentation acknowledging the target weight
  was not attained with an assessment of the
  reason for not attaining it, and a plan to correct
  this issue.
Blood Volume Monitoring and Post Dialysis Vascular
  Refill( Dry Weight Check) in 3 Different Patients.
             Arrows show end of ultrafiltration

                                                  BV reduction: 16%
                                                  No Vascular Refill

                                                  BV reduction: 12%
                                                  Vascular Refill


                                                  BV reduction: 6%
                                                  SLT Vascular Refill

                            Rodriguez et al Kidney Int 68:854,2005
           Rodriguez Summary
When used in combination with clinical
 assessment, the Crit-Line monitor results in:
• Optimization of Extracellular fluid status
• Reductions of intra and post dialysis morbid
• Improvements in patient well-being
• Potential reductions in hospitalization due to fluid overload

“Provides an objective way of assigning Dry Weight”
    V504: Blood Pressure and
    Fluid Management Needs

...”blood volume monitoring during
  hemodialysis should be available in order to
  evaluate body weight changes for gains in
  muscle weight vs. fluid overload”.

 - Mandated for pediatric patients
 - Imperative for adult patients
      V504: Blood Pressure and
      Fluid Management Needs
    The comprehensive assessment should
    include evaluation of the patient’s:
• Plan of Care
• Medications
• Pre/intra/post and interdialytic blood pressures,
• Interdialytic weight gains
• Target Weight vs. Ideal Dry Weight
• Related intradialytic symptoms (e.g., hypertension,
  hypotension, muscular cramping)‫‏‬
• Along with an analysis for potential root causes.
    Root Causes of Intradialytic
– Posture
– Low O2 saturation
– Medications / Antihypertensives
– Incorrect Ultrafiltration rate
– Hypotonic environment / Hypoalbuminemia
– Dialysate at body temperature or warmer: core body heating
– Splanchnic vasodilatation secondary to food ingestion
– Electrolyte/Acid-Base Imbalance
– Incorrect dialysis bath for individual patient
– Severe anemia (HCT <30) / Occult hemorrhage
– Unstable cardiovascular status / Arrhythmias / Pericardial
  tamponade / MI
– High Output failure related to high access blood flow rate
– Septicemia
– Dialyzer reaction, Hemolysis and Air embolisim
Root Cause Analysis Thru The Crit Line
  •   Anemia
  •   Hypoxemia
  •   Oxygen carrying capacity
  •   Hypervolemia
  •   Hypovolemia
  •   UFR is incorrect: too fast / too slow
  •   Patient is at dry weight
  •   Position effects
  •   Effects/ need for hypertonic; replacement fluid
  •   Low cardiac output ( SvO2 )
  •   Effects of eating
          Administration’s Next Step
• Assign a Fluid Manager to each facility

• Provide necessary technology

• Incorporate competency based fluid management & CLM
  training in orientation and annual in-services

• Educate patient / families on fluid management

• Ensure use of monitors each shift

• Approve Hema Metrics “ Recommended Guidelines” for CLM

• Order / reinforce “Dry Weight / Refill Checks”

                                                   PAGE 1
          Administration’s Next Step
• Round / Review profiles and tracking tools with staff

• Assess Medications on ongoing basis

• Reassess protocols for Sodium Modeling, Eating, use of
  Oxygen and Thermal Control

• Review hospitalization diagnosis for accuracy

• Analyze Root causes of IDM with staff

• Add Fluid Management into the facility QAPI program

                                                      PAGE 2
           Potential Quality Indicators
• Hospitalization rate : Hospitalization Causes

• Intradialytic events: Number / Type / Cause

• Incidence of Hypoxemia

• Access Morbidity

• Anemia Management : Hemoglobin variability

• Albumin levels

• Dry Weight changes
  PAGE 1
        Potential Quality Indicators
• Reduction in BP meds

• Left ventricular mass index (echo)

• Morbidity/ Mortality

• Economics

• Quality Of Life

• Patient Satisfaction

• Skipped Treatments / Early sign offs

                                         PAGE 2
        End – Section 2

Thank you for taking time to learn
about the new CMS Conditions of
Coverage as they relate to fluid
management, and how the Crit-Line
will assist you in achieving the new
       Additional Information
• Please call 1-800-546-5463 if you would
  like additional information or would be
  interested in evaluating Crit-Line at your
• Additional information can also be found at

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