Transcript Regulatory Issues: CLIA, JCAHO,CAP and States’ Perspective

POC Leadership Forum
Update on the Regulations
CLIA, CAP, JCAHO and COLA
Ronald H. Laessig, Ph.D.
University of Wisconsin
Madison, Wisconsin
www.cms.hhs.gov/clia
Purpose of U.S. Lab Regulations
… quality standards for all laboratory
testing to ensure
accuracy
reliability
timeliness
of patient test results regardless of
where the test is performed…
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#1
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#2
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#3
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#4
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#5
www.cms.hhs.gov/clia
Series of six slides from Glamour
Magazine
The latest information on test quality
Believe it or not
#6
www.cms.hhs.gov/clia
Quality POCT: What drives the
system?
According to Glamour Magazine:
….(we always go right to the source)
If Regulations are not
followed…...
...Human error follows
J. Yost, the “CLIA Lady”
Manufacturers’ Point of View
Evolution in Assured Quality
•Reduction in size
•Operator ID / Patient ID
•Reagent viability
•Lock-out quality control
•Connectivity
•Data management
Roche Diagnostics
Regulator’s Point of View
U.S. Regulations = CLIA
C = Clinical
L = Laboratory
I = Improvement
A = Amendments
Regulates ~180,000 U.S. test sites
http://www.cms.hhs.gov/clia/
Regulator’s Point of View
CLIA’88
(February 28, 1992)
CLIA’03
(January 24, 2003)
Linking Quality and Regulations
CLIA’s working premise:
CLIA’s mandated quality practices will
improve quality of test results
CLIA Regulations and the Director
The laboratory director is responsible for
the overall operation and administration
of the laboratory … [the] testing systems
… used [must] provide quality laboratory
services for all aspects of test
performance … including the preanalytic, analytic, and post-analytic
phases of testing
Quality POCT Challenge –
March 2004
Dilemma for today:
 With
the manufacturer buildingin/assuring quality,
 Where
is the professional input from the
laboratory director?
 Does the director just buy the
technology and use it?
What do we know today about
CLIA and Quality Requirements?
CLIA’03 takes a Quality Systems approach
like ISO documents
 The quality requirements follow the route
of the specimen




pre-analytical
analytical
post-analytical issues
CLIA and Quality Requirements?

The old CLIA covered the analytical requirements
in one section and quality assurance in another.

The new CLIA groups the quality requirements
under a new term “Quality Assessment”

Quality Assessment = Quality Control + Quality
Assurance

CLIA wants to consider the testing process start to
finish-hence “pre, post and analytical assessment”
CLIA ‘03 and QC?
Control procedures must (§493.1256):

Monitor the accuracy and precision of the complete
analytical process

Detect immediate errors due to test system failure,
adverse environmental conditions, and operator
performance

Monitor over time precision and accuracy that may
be influenced by changes in test system,
environment and operator performance
CLIA’03 and QC?
Control procedures must (§493.1256):
Monitor complete analytical process
 Detect immediate errors
 Monitor over time precision and accuracy

Conceptually, meeting the requirements
sounds easy,
But ---
CLIA’03 and QC?
Control procedures must (§493.1256):
Monitor complete analytical process
 Detect immediate errors
 Monitor over time precision and accuracy

Conceptually, meeting the requirements
sounds easy,
But ---
CLIA ’03 and Q C
The Devil is in the Details
CLIA’03 – The details!

What about




Electronic QC?
Process controls?
Internal controls?
Do these
a)
b)
c)
d)
evaluate complete analytical process
detect immediate errors
monitor accuracy and precision over time
none of the above
Details - 12 January 2004
Interpretive Guidelines for CLIA – 300+ pages
NEW and More
http://www.cms.hhs.gov/clia/appendc.asp
New Concept for QC?
EQC
Equivalent Quality Control
New Concept for QC?
EQC =
Electronic Quality Control
What is Equivalent QC (EQC)?
 For
instruments with procedural/internal
controls, test sites can choose to:
 Analyze
2 external, liquid controls per day
OR
 Qualify
the procedural/internal controls as one
of three EQC options
EQC Option #1
 Test
Systems with internal/procedural
control(s) that monitor the entire analytic
process
 Test
site may use EQC, if test
system’s stability is demonstrated
EQC #1 - Evaluation of Stability

Along with internal/ process controls, run 2
external QC daily for 10 consecutive days (why
10?)

If internal/process and external control results
are acceptable (what is acceptable?)


reduce external QC from daily to once / month unless
manufacturer requires more
Lab must perform/monitor the internal control(s)
in accordance with manufacturer instructions
Option #1
Instrument with manufacturer
supplied on board controls, run
automatically.
EQC Option #2
 Test
Systems with internal/procedural
control(s) that monitor a portion of the
analytic process
 Test
site may use EQC, if test
system’s stability is demonstrated
Option #2 - Evaluation of Stability

Along with internal process controls, run 2
external QC daily for 30 consecutive days (why
30?)

If internal and external control results are
acceptable (what is acceptable?)


reduce external QC from daily to once / week unless
manufacturer requires more
Lab must perform/monitor the internal control(s)
in accordance with manufacturer instructions
Option #2
Hand held instrument currently
advertized as having on board,
electronic controls.
EQC #3
 Test
Systems without Internal/Procedural
Control(s)
 Advancements
systems
in technology have produced
– Capable of maintaining stable performance
specifications over time
– Minimally influenced by adverse environmental
conditions and operator variance.
 Test
site may use EQC, if test system’s
stability is demonstrated
Option #3 - Evaluation of Stability

Along with internal process controls, run 2
external QC daily for 60 consecutive days (why
60?)

If internal and external control results are
acceptable (what is acceptable?)


reduce testing external QC from daily to once / week
unless manufacturer requires more
Lab must perform/monitor the internal control(s)
in accordance with manufacturer instructions
Option #3?
What belongs in this
picture?
Option #3?
Every Instrument!
Vitros
Hitachi
aca, SMAC,
etc.
Prove stability for 60 days, run
external QC once per week
CLIA – “Equivalent” QC (EQC)
“The director must consider the laboratory’s
clinical and legal responsibility for
providing accurate and reliable patient test
results versus the cost implications of
reducing the QC testing frequency.”
EQC is a choice!
Uncle Sam
Has Uncle Sam gone Crazy?
Uncle Sam
Has Uncle Sam gone Crazy?
 Maybe
or Maybe Not!
March 2004
Does EQC and the U.S. regulations
open a new era for
new technologies
or
does EQC just cause confusion?
Quality POCT: What Drives the
System?
 To
me, CLIA QC regulations say –
 Continue
the “old” way – 2 external
QC/day
 Qualify the test system under EQC
options and reduce frequency of
external QC
Quality POCT: What Drives the
System?

To me, CLIA QC regulations say –
 Continue the “old” way – 2 external QC/day
 Qualify the test system under EQC options
and reduce frequency of external QC
 EQC
Option #3 ( for a test system with
no internal/process controls)
 Do
you want your testing done on a system
that qualifies under this option?
The Devil is in the details
 EQC
Qualified System – External QC
analyzed once per month or once per
week.

EQC-1
EQC-2&3
“The Devil is in the Details”
§493.1282 Standard: Corrective actions
…[if] external QC [results]…fail to meet
the laboratory's established criteria for
acceptability, all patient test results
obtained…since the last acceptable test
run must be evaluated to determine if
patient test results have been adversely
affected…
Quality POCT: Drivers?
 Manufacturers
– Building the perfect
instrument to meet the needs of the
testing environment
CLIA’s new QC/EQC Requirements
 Have
a two-year phase in
 Inspection
 Citations
 NO
punitive activities
Manufacturers have “EQ”
Options #1, 2, & 3
To be competitive in the marketplace,
options #2 and #3 DON’T count
The bottom line…..the “Regs”

We are in a two year phase in
 We are all trying to figure out what they
mean
 At the end of the day, the laboratory
director must make the call -- QC or EQC
(1,2,or 3)
 We are after all in the patient care
business
 Legally, Morally, ethically, technically, the
patients (must) always come first.
CLIA Regulations and the Director
The laboratory director is responsible for
the overall operation and administration
of the laboratory … [the] testing systems
… used [must] provide quality laboratory
services for all aspects of test
performance … including the preanalytic, analytic, and post-analytic
phases of testing
…..and
Speaking
of Lab
Directors,
Heerrrrrs Fritz !!!!!