CFC Power Point Presentation

Meeting The Fluid Management Conditions of Coverage

Thru Crit-Line Monitor Use

TODAY’S PRESENTER

Diana Hlebovy RN, BSN, CHN, CNN

Director of Clinical AffairsHema Metrics

Objectives• Discuss the rationale for adding fluid

management into the Conditions of Coverage (CfC)

• 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 Comments

• 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 494.80

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.


• CMS received several comments regarding §494.90(a)(1), “Dose of dialysis.”

• Some commenters suggested we include patient volume status ( measurement of body fluid removal) in the adequacy requirement


• 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 494.90

• 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 status”

“Protect the Pump ”

The principal goal of these conditions is to improve cardiovascular outcomes

by optimizing fluid management

practices and strategies during hemodialysis


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 Plan

(QAPI)

“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


Current Trends

Current Trend :SafeOccurrence 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


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 arrest.

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


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 admissions

• 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

Cary, 2002

80-90%2002

75%1997

10%1970


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 Weights”

• “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

sodium concentration should be avoided.


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

• 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 needs(V501)

Current Trend: Patient Centered

• Oxygen needs are rarely assessed

• Root causes for IDMs rarely assessed

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

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

• Patients are labeled “noncompliant” if fluid gains are excessive

• Patients are blamed for the cause of crashing

• Staff/ Patients believe that if they “crash” they have reached their EDW

2

Intra-Intra-cellular cellular SpaceSpace Extra-Extra-

cellular cellular SpaceSpace

Intra-Intra-Vascular Vascular SpaceSpace

Circulating Circulating Blood VolumeBlood Volume

Toxins

Fluid

Toxins

Fluid

Toxins

Fluid

Dialyzer

Three Compartment Model Fluid Shifts

23 Liters 17 Liters 5 Liters

Dialysis Assessment

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


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 care

This requirement is not met/ not satisfied if:

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

• 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-adherence.”

Current Trend: Timely

• Treatment of IDMs are reactive vs. proactive

• EDW is changed after event or admission for CHF

• 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 removal

• Medicare budget is significantly impacted


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•Hypotension•Hypertension•Need for extra treatment for fluid removal•Sudden onset of cardiac arrhythmias


Change Concepts:

• The goal of ultrafiltration is to obtain normovolemia and normotension without Intradialytic morbidities (IDMs).

• This along with solute clearances comprises

adequacy of dialysis

V543:Dose of dialysis

Defines EDW- and the inter/ intradialytic measures that will be used to evaluate the outcomes:

• A patient at their EDW should be: - asymptomatic and - normotensive - on minimum blood pressure

medications - while preserving organ perfusion and - maintaining existing residual renal

function


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”.Scribner BH: AJKD;6:511-519,1990

The new conditions of coverage also

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 include

specific competencies such as :

• Identifying and treating intradialytic morbidities

• Monitoring patients

• Equipment alarms

Crit-Line Monitor:The Gold Standard of

Optimal 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 Overload

> 45% Reduction in Hospitalizations due to Access Complications (See Howard, et al.)

55% Reduction in Left Ventricular Hypertrophy

Crit-Line’s Clinical Impact in Fluid Management

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

Patient Recovery Time, AMA’s, Rehabilitation Potential

Financial CostsHospitalizations/Hospital Days

Medications/IV Solutions to TX SX

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),

Hospitalizations/Morbidity/mortality/Economics/QOL, 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 clinic

• Additional information can also be found at www.hemametrics.com

http://www.hemametrics.com/

Section 2Crit-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 conditions.

• Hematocrit (HCT)

• O2 Saturation (SAT)

• Change in Blood Volume (BV)

Emitter

Blood Flow

Blood Chamber

Detector

FDA 510k Approved CRIT-LINE Parameters

Multi-parameter Platform

Total BloodVolume (BV)

Red Cell Volume(RCV)

Test tube representscirculating blood volume

Hct =RCV

BV

PlasmaVolume

Fundamental Parameter: Hematocrit (Hct)

Total BloodVolume (BV)

Red Cell Volume (RCV)

=HCT RCV

BV

HEMATOCRIT

(Test tube represents

circulating blood volume)

0 1 2 3 4

0

-5

-10

-15

-20

-25

27

29

31

33

35

%B

V (

Lo

ss)

Hc

t

Hct =RCVBV

X 100

Hematocrit and Blood Volume

HYPOXEMIA DURING HEMODIALYSIS

Blocks the release of

norepinephrine

from

sympathetic

nerve

terminals

Blocks the release of

norepinephrine

from

sympathetic

nerve

terminals

Releases adenosineReleases adenosine

This tissue

ischemia effect

maybe the reason

that anemic

patients are prone

to hypotension.

.

This tissue

ischemia effect

maybe the reason

that anemic

patients are prone

to hypotension.

TISSUE ISCHEMIATISSUE ISCHEMIATISSUE ISCHEMIA

Types of Hypoxia: Causes in ESRD

• Hypoxemic Hypoxia Fluid excess

COPD; ↓CO2 Sleep Apnea

• Anemic Hypoxia Anemia (Hgb ≤ 10)

• Circulatory Hypoxia Cardiac Dysfunction,

arteriosclerosis

• Histotoxic Hypoxia L shift of saturation

curve; alkalosis;

↓CO2; sepsis

Factors to Consider:Source

Arterial Blood: Internal Access ( Fistula /Graft)

• Mixed Venous Blood: CVC line

• 90 to 100% is considered normal for arterial sats (SaO2)

• 60 to 80% for mixed venous sats (SvO2)

02 Delivery 20+ % of HD patients have intradialytic

hypoxemia and up to 70% are sleep apneics.

0 1 2 3 4Time (hours)

80

85

90

95

Ox

yg

en S

atu

rati

on

Sleep Apnea Profile

Sleep

Complimentary Oxygen Delivery Issues

Access: Catheter

SvO2

Venous BloodVenous BloodLower OLower O22 Saturation Saturation

Factors to Consider:Source

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

0

1

2

3

4

5

6

7

8

5 10 15 20 25 30 35 400

Adapted from Guyton, AC: Textbook of Medical Physiology, 1991, pg.324

Normal

Death

Edema

Blo

od

Vo

lum

e (l

ite

rs)

Extracellular Fluid Volume (liters)

The Guyton Curve

2

Intra-Intra-cellular cellular SpaceSpace Extra-Extra-

cellular cellular SpaceSpace

Intra-Intra-Vascular Vascular SpaceSpace

Circulating Circulating Blood VolumeBlood Volume

Toxins

Fluid

Toxins

Fluid

Toxins

Fluid

Dialyzer

Three Compartment Model Fluid Shifts

23 Liters 17 Liters 5 Liters

012

3

45

67

8

5 10 15 20 25 30 35 400

Adapted from Guyton, AC: Textbook of Medical Physiology, 1991,

pg.324

Normal

Death

AEdema

Blo

od

Vo

lum

e (l

iter

s)


TIME 03:25 HCT 31.2 BV 0.2 SAT 98-20

0

-10

5

BV

-20

-10

0

5

Time (hr)

1 2 3 4 5

0

1

2

3

4

5

6

7

8

5 10 15 20 25 30 35 400

Adapted from Guyton, AC: Textbook of Medical Physiology, 1991, pg.324

Normal

Death

BB

loo

d V

olu

me

(lit

ers

)


TIME 03:25 HCT 34.7 BV -17.3 SAT 94-20

0

-10

5

BV

V543Dose of Dialysis

Evidence of implementation of the plan of care for this aspect would include:

• Treatment records reflecting attaining the target weight at the end of each treatment

or • 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

Hours

Hours

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 complications• 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 Morbidities

– 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 (QA)– Septicemia– Dialyzer reaction, Hemolysis and Air embolisim

Root Cause Analysis Thru The Crit Line Monitor

• 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 use

• 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 mandates.

Additional Information

• Please call 1-800-546-5463 if you would like additional information or would be interested in evaluating Crit-Line at your clinic

• Additional information can also be found at www.hemametrics.com

http://www.hemametrics.com/

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