| DESCRIPTION OF ENHANCEMENTS |
EFFECT ON BLOOD BANK FUNCTIONAL REQUIREMENTS: Patch LR*5.2*289 does not
to be setup in the same panel, which can be in either a new panel or, an
about $55,000 per year per patient for preventing or delaying dialysis. This
does not take into account the morbidity associated with dialysis that will
be prevented.
Raye-Anne Dorn, National Tumor Registry Coordinator, has submitted a New
Service Request for the creation of a laboratory test, the estimated
Glomerular Filtration Rate, eGFR. Thakor G. Patel, MD, Chief of Renal
Diseases at Veterans Administration Central Office, endorses the request. The
endorser is seeking an alternative to the creatinine clearance test, a
laboratory test that measures renal function and requires all urine collected
existing panel.
over a 24-hour period. The request cites the difficulty of collecting such a
specimen, particularly from elderly patients. Additionally, the Veterans
Health Administration (VHA) Renal Program Office has recommended a standard
process throughout VHA for performing and reporting the eGFR. The request is
to release this locally created delta check as Class 1 software.
The four-variable MDRD Study equation is recommended. Although it has
short-comings, it has been more rigorously evaluated than the Cockcroft and
Gault equation, and performs better in patients with kidney disease, gives
results in units of ml/min/1.73 m^2, and does not require measurement of
weight. Performance can be improved by calibration of the VA lab results
with the MDRD Study lab (Cleveland Clinic). Is there a VA "central lab,"
that other labs relate to? If so, it should be possible to "calibrate" that
lab to the MDRD Study lab. (Of course, there is no Cockcroft Gault central
lab, so calibration is an uncorrectable error with the use of the Cockcroft
and Gault equation.)
The view is that it is difficult to interpret GFR values above about 60
ml/min/1.73 m^2, due to differences in creatinine calibration among labs, and
uncertainty in the measurement of GFR in that range. This is the reason
-----------------------------
that the NKF defined CKD Stage 3 as GFR <60, and that there are few
differences in the action plan for CKD stages 1 and 2 (kidney damage and
GFR either greater than or less than 90). It is important to instruct
practitioners about the limitations of GFR estimates above 60.
Stages of chronic kidney disease (R, O). Among individuals with chronic kidney
disease, the stage is defined by the level of GFR, with higher stages
representing lower GFR levels.
Table 12. Definition and Stages of Chronic Kidney Disease
Background
GFR With Kidney Damage* Without Kidney Damage*
__________________________ __________________________
Stages (mL/min/1.73^2) With HBP** Without HBP** With HBP** Without HBP**
______________________________________________________________________________
1 >=90 1*** 1*** "High blood "Normal"
pressure"
------------------------------------------------------------------------------
2 60-89 2*** 2*** "High blood "eGFR"
pressure with
eGFR"
------------------------------------------------------------------------------
3 30-59 3*** 3*** 3*** 3***
------------------------------------------------------------------------------
4 15-29 4*** 4*** 4*** 4***
------------------------------------------------------------------------------
5 <15(or 5*** 5*** 5*** 5***
dialysis)
______________________________________________________________________________
Chronic kidney disease is a major public health problem. Adverse outcomes of
* Kidney damage is defined as pathologic abnormalities or markers of
damage, including abnormalities in blood or urine tests or imaging
studies.
** High blood pressure is defined as >= 140/90 in adults and >90th
percentile for height and gender in children.
*** Represent chronic kidney disease; numbers designate stage of chronic
kidney disease.
May be normal in infants and in the elderly.
chronic kidney disease can be prevented through early detection and treatment.
Table 12 illustrates the classification of individuals based on the presence
or absence of markers of kidney disease and level of GFR, according to
definition and staging of chronic kidney disease proposed by this guideline.
In addition, it includes columns for the presence or absence of high blood
pressure, because of the complex relationship of high blood pressure and
chronic kidney disease.
All individuals with GFR <60 mL/min/1.73 m2 for 3 months are classified as
Earlier stages of chronic kidney disease can be detected through routine
having chronic kidney disease, irrespective of the presence or absence of
kidney damage. The rationale for including these individuals is that reduction
in kidney function to this level or lower represents loss of half or more of
the adult level of normal kidney function, which may be associated with a
number of complications (Part 6).
All individuals with kidney damage are classified as having chronic kidney
disease, irrespective of the level of GFR. The rationale for including
individuals with GFR 60 mL/min/1.73 m2 is that GFR may be sustained at normal
or increased levels despite substantial kidney damage and that patients with
laboratory measurements.
kidney damage is at increased risk of the two major outcomes of chronic kidney
disease: loss of kidney function and development of cardiovascular disease
(Part 7).
-----------------------------
The four-variable MDRD Study equation
Estimated GFR (ml/min/1.73m^2)
= 186 x (Scr)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.210 if
African - American)
contain any changes to the VISTA BLOOD BANK Software as defined by VHA
where:
Scr = serum creatinine in mg/dL
Age = age, in years
("four-variable" (abbreviated) equation in Levey AS, JASN vol. 11:2000;
abstract - A0828) (see below)
A0828 F138 (PS)
The USRDS provides reliable nationwide data regarding the incidence,
A. Simplified Equation To Predict Glomerular Filtration Rate from Serum
Creatinine, Andrew S. Levey,(1) Tom Greene,(2) John W. Kusek,(3) Gerald J.
Beck,(2) MDRD Study Group. (1) Boston, MA, (2) Cleveland, OH, (3) Bethesda,
MD.
We recently developed and validated an equation to predict GFR from serum
creatinine (Pcr), which is more accurate than creatinine clearance measured
from 24-hour urine samples or predicted from the Cockcroft-Gault (CG) equation
(Levey AS, Ann Intern Med 1999; l30:877-884). GFR is expressed as ml/min/l.73
m^2. Required variables include Pcr (mg/dl), age (y), race (black vs.
prevalence, treatment patterns, outcomes, and cost of kidney failure treated
non-black), gender, serum urea nitrogen (SUN, mg/dl), and albumin (alb.g/dl).
In clinical practice and in retrospective studies, measurements of SUN and
alb may not be available. Below, we list the full MDRD Study prediction
equation (6 variables), as well as alternative prediction equations including
fewer variables derived from measurements in the same 1628 patients.
GFR = 170 x Pcr-0.999 x age -0.176 x 1.180 (if black)
x 0.762 (if female) x SUN-0.170 x alb+0.318
GFR = 270 x Pcr-l.007 x age -0.180 x 1.178 (if black)
x 0.755 (if female) x SUN-0.169
by dialysis and transplantation, the most severe stage of chronic kidney
GFR = 186 x Pcr-l.154 x age -0.203 x 1.212 (if black)
x 0.742 (if female)
The table below compares the performance of these equations and the CG
equation.
R 2 median A 75th % A 90th % A
6 variable .903 11.3 19.8% 28.4%
5 variables .899 11.6% 19.9% 29.4%
4 variable .892 12.1% 20.5% 29.7%
disease. This guideline provides a definition of chronic kidney disease as
CG .842 13.8% 26.4% 40.5%
A=absolute value of the median (50th), 75th and 90th percentiles of the
distribution of the differences between measured GFR and predicted GFR or Ccr
for each equation (includes bias correction for CG equation). We conclude
that simplified versions of the MDRD Study prediction equation provide more
accurate estimates of GFR than measured or estimated creatinine clearance.
Example of Screen:
well as definitions and estimates of prevalence of earlier stages of kidney
ACCESSION: CH 0205 3 CH 0205 4
2/5 12:01d 2/5 12:50d
CREATININE //1.2
(MISSING PARAMETER)
** eGFR: 74.6
VOLUME //932
ELAPSED TIME //5.5
COMPUTED CREATININE CLEARANCE //23 L
disease.
CREATININE EGFR 74.6//
Select COMMENT: MISSING PARAMETER //
COMMENT: MISSING PARAMETER //
Select COMMENT:
***************************************************************************
* NOTE: *
* If the patients race is 'Undeclared' or 'Unanswered', the COMMENT field *
* will be populated with 'MISSING PARAMETER' text. The doctor will be able*
* view this information within CPRS. The delta check will calculate the *
* formula without the race variable. The doctor will need to evaluate this*
* when viewing the reports in CPRS. *
***************************************************************************
-----------------------------
New Fields
There are four new fields: three TEST NAME FOR INPUT VALUEs (#60.1, #60.2,
#60.3) and one TEST NAME FOR TEST OUTPUT VALUE (#61.1), which are stored in
the file DELTA CHECKS (#62.1). The new fields are pointers to file LABORATORY
Chronic kidney disease is defined according to the presence or absence of
TEST (#60). The new fields will be used by the delta check routine to get
the DATA NAME (#400) field, which is a pointer to CHEM, HEM, TOX, RIA, SER,
etc. DD File SUB-FIELD (#63.04). When the delta check routine is invoked, the
routine calculates the eGFR from the test result, age, gender, and race.
The results of the calculation are stored in the local array LRSB(DATA NAME).
File/Field Field Name Node;Piece Field Type
-------------------------------------------------------------------------------
kidney damage and level of kidney function-irrespective of the type of kidney
62.1,60.1 TEST NAME FOR INPUT VALUE 1 5;1 POINTER TO LABORATORY TEST FILE
(#60)
LAST EDITED: SEP 24, 2002
DESCRIPTION: This field is a pointer to a test that will
contain the result value of the first incoming
test. The result value should be stored in the
variable LRSB(X) - where X is the data name IEN
from ^DD(63.04.
DIRECTIVE 99-053 titled VISTA BLOOD BANK SOFTWARE VERSION 5.2.
disease (diagnosis). Among individuals with chronic kidney disease, the stages
62.1,60.2 TEST NAME FOR INPUT VALUE 2 5;2 POINTER TO LABORATORY TEST FILE
(#60)
LAST EDITED: SEP 24, 2002
DESCRIPTION: This field is a pointer to a test that will
contain the result value of the second incoming
test. The result value should be stored in the
variable LRSB(X) - where X is the data name IEN
from ^DD(63.04.
are defined based on the level of kidney function. Identifying the presence
62.1,60.3 TEST NAME FOR INPUT VALUE 3 5;3 POINTER TO LABORATORY TEST FILE
(#60)
LAST EDITED: SEP 24, 2002
DESCRIPTION: This field is a pointer to a test that will
contain the result value of the third incoming
test. The result value should be stored in the
variable LRSB(X) - where X is the data name IEN
and stage of chronic kidney disease in an individual is not a substitute for
from ^DD(63.04.
62.1,61.1 TEST NAME FOR OUTPUT VALUE 1 5;4 POINTER TO LABORATORY TEST FILE
(#60)
LAST EDITED: SEP 24, 2002
DESCRIPTION: This field is a pointer to a test that will
contain the calculated value of the first
outgoing test. The calculated value should be
accurate assessment of the cause of kidney disease, extent of kidney damage,
stored in the variable LRSB(X) - where X is the
data name IEN from ^DD(63.04.
-----------------------------
The eGFR delta check will need to be associated a new or existing Serum
Creatinine test. The tests called EGFR and CREATININE (INCLUDES EGFR) will
need to be setup and then associated with the Serum Creatinine.
Example of Laboratory Test Setup: (THIS IS A DISPLAY OF ENTRIES IN THE FILE,
NOT A CAPTURED EXAMPLE OF A SETUP USING FILEMAN)
level of kidney function, comorbid conditions, complications of decreased
NAME: CREATININE,SERUM TYPE: OUTPUT (CAN BE DISPLAYED)
SUBSCRIPT: CHEM, HEM, TOX, SER, RIA, ETC.
LOCATION (DATA NAME): CH;689024;1 FIELD: DD(63.04,689024,
HIGHEST URGENCY ALLOWED: ROUTINE COMBINE TEST DURING ORDER: YES
PRINT NAME: CREAT DATA NAME: CREATININE-EGFR
SITE/SPECIMEN: SERUM REFERENCE LOW: 0.7
REFERENCE HIGH: 1.5 UNITS: mg/dl
TYPE OF DELTA CHECK: EGFR LOINC CODE: 2160-0
COLLECTION SAMPLE: BLOOD MIN VOL (in mls.): .2
kidney function, or risks for loss of kidney function or cardiovascular
SINGLE DAY MAX ORDER FREQ: 1
INSTITUTION: WASHINGTON ACCESSION AREA: CHEMISTRY
VERIFY WKLD CODE: Creatinine VERIFY WKLD CODE #: 82565.0000
CIS TEST CODE: CH017
SITE NOTES DATE: JAN 17, 2002
NOTE: Created per Raye-Ann Dorn. Part of Creatinine (Includes EGFR) panel.
NATIONAL VA LAB CODE: Creatinine RESULT NLT CODE: Creatinine
NAME: EGFR TYPE: OUTPUT (CAN BE DISPLAYED)
disease in that patient. Defining stages of chronic kidney disease requires
SUBSCRIPT: CHEM, HEM, TOX, SER, RIA, ETC.
LOCATION (DATA NAME): CH;689023;1 FIELD: DD(63.04,689023,
HIGHEST URGENCY ALLOWED: ROUTINE PRINT NAME: EGFR
DATA NAME: EGFR
SITE/SPECIMEN: SERUM
SYNONYM: ESTIMATED GLOMERULAR FILTRATION RATE
SYNONYM: GLOMERULAR FILTRATION RATE
INSTITUTION: WASHINGTON ACCESSION AREA: CHEMISTRY
SITE NOTES DATE: JAN 17, 2002
NOTE: Per Raye-Ann Dorn. Part of Creatinine (Includes EGFR) panel.
"categorization" of continuous measures of kidney function, and the "cut-off
NAME: CREATININE (INCLUDES EGFR) TYPE: BOTH
SUBSCRIPT: CHEM, HEM, TOX, SER, RIA, ETC.
LAB COLLECTION SAMPLE: BLOOD HIGHEST URGENCY ALLOWED: ROUTINE
PRINT NAME: CR EGFR
NUMBER: 1 LAB TEST: CREATININE,SERUM
NUMBER: 2 LAB TEST: EGFR
COLLECTION SAMPLE: BLOOD
INSTITUTION: WASHINGTON ACCESSION AREA: CHEMISTRY
levels" between stages are inherently arbitrary. Nonetheless, staging of
SITE NOTES DATE: JAN 17, 2002
NOTE: Per Raye-Ann Dorn. Includes CREATININE EGFR and EGFR with a delta
check of EGFR.
-----------------------------
If setting up the eGFR delta check, use FILEMAN to setup the new DELTA CHECK
fields. The TEST NAME FOR INPUT VALUE 1 field (#60.1) and TEST NAME FOR OUTPUT
VALUE 1 field (#61.1) are pointers to DATA NAME field (#400) of the LABORATORY
TEST (#60) files. These fields will be needed to run the delta check.
chronic kidney disease will facilitate application of clinical practice
Example of Delta Check Setup: (THIS IS A DISPLAY OF ENTRIES IN THE FILE,
NOT A CAPTURED EXAMPLE OF A SETUP USING FILEMAN)
NAME: EGFR XECUTABLE CODE: D STRT^LREGFR(DFN,X)
DESCRIPTION: Created 10/17/01 by SDV for Dr. TG Patel and Raye-Ann Dorn.
Test is CREATININE-EGFR and its delta test is EGFR which Lon Paredes set and
tested. On 08/01/2002, JAH modified and sent out as Class I software.
SITE NOTES DATE: AUG 01, 2002
TEST NAME FOR INPUT VALUE 1: CREATININE,SERUM
TEST NAME FOR OUTPUT VALUE 1: EGFR
guidelines, clinical performance measures and quality improvement efforts to
-----------------------------
Setting Up INPUT and OUTPUT VALUE
Use FILEMAN to enter the INPUT and OUTPUT VALUE(s). These two pointers will
store the file LABORATORY TEST (#60) IEN in the file DELTA CHECKS (#62.1).
This information will be used to acquire the field DATA NAME (#400) for
the Laboratory test, which was setup to call the delta check routine. Below
is an example of a session:
the evaluation, and management of chronic kidney disease.
Select OPTION: ENTER OR EDIT FILE ENTRIES
INPUT TO WHAT FILE: DISABILITY CONDITION// DELTA CHECKS
EDIT WHICH FIELD: ALL// ??
Choose from:
.01 NAME
10 XECUTABLE CODE
20 OVERFLOW 1
30 DESCRIPTION (word-processing)
31 SITE NOTES DATE (multiple)
60.1 TEST NAME FOR INPUT VALUE 1
60.2 TEST NAME FOR INPUT VALUE 2
60.3 TEST NAME FOR INPUT VALUE 3
61.1 TEST NAME FOR OUTPUT VALUE 1
FOLLOW A FIELD NAME WITH ';"CAPTION"' TO HAVE THE FIELD ASKED AS 'CAPTION:'
OR WITH ';T' TO USE THE FIELD 'TITLE' AS CAPTION
EDIT WHICH FIELD: ALL// 60.1 TEST NAME FOR INPUT VALUE 1
THEN EDIT FIELD: 61.1 TEST NAME FOR OUTPUT VALUE 1
-----------------------------
THEN EDIT FIELD:
Select DELTA CHECKS NAME: EGFR
TEST NAME FOR INPUT VALUE 1: CREATININE,SERUM//
TEST NAME FOR OUTPUT VALUE 1: EGFR//
ASSOCIATED NOIS
===============
Reasons for estimated Glomerular Filtration Rate (eGFR)
N/A
TEST SITES
===============
Washington D.C.
VA Wilmington
Long Beach VAMC Laboratory
VAMHCS, PERRY POINT DIVISION
ROUTINE SUMMARY
===============
The following routines are included in this patch. The second line of each
of these routines now looks like:
;;5.2;LAB SERVICES;<patchlist>;Sep 27, 1994
Checksum
Routine Old New 2nd Line
In February 2002, the National Kidney Foundation recognized the Glomerular
-----------------------------------------------
LREGFR n/a 2490467 **289**
Sites should use CHECK^XTSUMBLD to verify checksums.
************************************************************************
INSTALLATION INSTRUCTIONS
=========================
Filtration Rate as an indicator of renal function. The eGFR is calculated
The install time for this patch is less than five minutes. This patch can be
installed when Laboratory users are on the system. Suggested time to install:
non-peak requirement hours.
NOTE: Kernel patches must be current on the target system to avoid problems
loading and/or installing this patch.
Patch installation needs to be coordinated with the Laboratory
rather than measured, and the Washington, DC Medical Center has developed a
Information Manager (LIM/ADPAC).
1. If any of the above routines are mapped, disable mapping for them.
2. Use the 'INSTALL/CHECK MESSAGE' option of the PackMan menu. This
option will load the KIDS patch onto your system.
3. On the 'Kernel Installation & Distribution System' Menu (KIDS), select
the 'Installation' menu.
routine known as a delta check that performs the calculation. The Washington
4. Use the 'Verify Checksum in Transport Global' option and verify that
all routines have the correct checksums.
5. On the KIDS menu, under the 'Installation' menu, use the following
options:
Print Transport Global
Compare Transport Global to Current System
Backup a Transport Global
LR*5.2*289 is a mandated installation of the estimated Glomerular Filtration
delta check uses the serum creatinine result, age, and sex from the local
6. Use the 'Install Package(s)' option under the 'Installation' menu and
select the package LR*5.2*289. When prompted 'Want KIDS to INHIBIT
LOGONs during the install? YES//' choose 'NO'. When prompted 'Want to
DISABLE Scheduled Options, Menu Options, and Protocols?
YES//', choose 'NO'.
7. On a mapped system, rebuild your map set.
*****************************************************************************
VISTA Laboratory package. The new program will calculate the eGFR for African-
Americans and others according to the accepted calculation.
It is important to note that National Kidney Foundation's "Kidney Disease
Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines for Chronic
Kidney Disease: Evaluation, Classification, and Stratification" has stages of
kidney disease based on eGFR and also action plan as per Guidelines 1 & 2.
These guidelines are published in the American Journal of Kidney Diseases Vol.
39, No 2, supplement 1, February 2002.
Rate (eGFR) delta check routine. Site(s) can setup the two new laboratory
Adverse outcomes of chronic kidney disease can often be prevented or delayed
through early detection and treatment. Earlier stages of chronic kidney
disease can be detected through routine laboratory measurements.
* The presence of chronic kidney disease should be established, based on
presence of kidney damage and level of kidney function (glomerular
filtration rate [GFR]), irrespective of diagnosis.
* Among patients with chronic kidney disease, the stage of disease should
tests, Creatinine (including eGFR) and eGFR, in either a new or an existing
be assigned based on the level of kidney function, irrespective of
diagnosis, according to the K/DOQI CKD classification Table 10.
Table 10: Stages of Chronic Kidney Disease
GFR
Stage Description (mL/min/1.73m^2)
_____________________________________________________________________
1 Kidney damage with >=90
Serum Creatinine test. One of the new tests holds the input value (test
normal or increasing GFR
---------------------------------------------------------------------
2 Kidney damage with 60-89
mild decreasing GFR
---------------------------------------------------------------------
3 Moderate decreasing GFR 30-59
---------------------------------------------------------------------
4 Severe decreasing GFR 15-29
---------------------------------------------------------------------
5 Kidney failure <15(or dialysis)
result) and the other test holds the calculated output value. Both tests need
_____________________________________________________________________
Notes: Chronic kidney disease is defined as either kidney damage
or GFR <60 mL/min/1.73m^2 for >=3 months. Kidney damage is defined
as pathologic abnormalities or markers of damage, including
abnormalities in blood or urine tests or imaging studies.
VHA is probably one of the few organizations nationwide that has the potential
to report eGFR whenever serum creatinine is done. This will help us identify
patients with kidney disease early and take preventive action. We will save
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