POC Leadership Forum

POC Leadership Forum

Update on the Regulations

CLIA, CAP, JCAHO and COLA

Ronald H. Laessig, Ph.D.University of Wisconsin

Madison, Wisconsinwww.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 followsJ. 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 = ClinicalL = LaboratoryI = ImprovementA = Amendments

Regulates ~180,000 U.S. test siteshttp://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 pre-analytic, analytic, and post-analytic phases of testing

Quality POCT Challenge – March 2004

Dilemma for today:

With the manufacturer building-in/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 thesea) evaluate complete analytical processb) detect immediate errorsc) monitor accuracy and precision over timed) none of the above

Details - 12 January 2004

http://www.cms.hhs.gov/clia/appendc.asp

NEW and MoreInterpretive Guidelines for CLIA – 300+ pages

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 in technology have produced

systems– 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?

Prove stability for 60 days, run external QC once per week

Every Instrument!

Vitros

Hitachi

aca, SMAC,

etc.

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/dayQualify 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 pre-analytic, analytic, and post-analytic phases of testing

…..and

Speaking of Lab Directors,

Heerrrrrs Fritz !!!!!