POC Leadership Forum

1
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
2
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
3
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 1

www.cms.hhs.gov/clia
4
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 2

www.cms.hhs.gov/clia
5
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 3

www.cms.hhs.gov/clia
6
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 4

www.cms.hhs.gov/clia
7
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 5

www.cms.hhs.gov/clia
8
Series of six slides from Glamour Magazine

• The latest information on test quality
• Believe it or not
• 6

www.cms.hhs.gov/clia
9
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

10
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
11
Regulators 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/
12
Regulators Point of View

• CLIA88
• (February 28, 1992)
• CLIA03
• (January 24, 2003)

13
Linking Quality and Regulations

• CLIAs working premise
• CLIAs mandated quality practices will improve
  quality of test results

14
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

15
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?

16
What do we know today about CLIA and Quality
Requirements?

• CLIA03 takes a Quality Systems approach like ISO
  documents
• The quality requirements follow the route of the
  specimen
• pre-analytical
• analytical
• post-analytical issues

17
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

18
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

19
CLIA03 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 ---

20
CLIA03 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 ---

21
CLIA 03 and Q C

• The Devil is in the Details

22
CLIA03 The details!

• What about
• Electronic QC?
• Process controls?
• Internal controls?
• Do these
• evaluate complete analytical process
• detect immediate errors
• monitor accuracy and precision over time
• none of the above

23
Details - 12 January 2004
http//www.cms.hhs.gov/clia/appendc.asp
24
New Concept for QC?

• EQC
• Equivalent Quality Control

25
New Concept for QC?
26
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

27
EQC Option 1

• Test Systems with internal/procedural control(s)
  that monitor the entire analytic process
• Test site may use EQC, if test systems stability
  is demonstrated

28
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

29
Option 1

• Instrument with manufacturer supplied on board
  controls, run automatically.

30
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 systems stability
  is demonstrated

31
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

32
Option 2

• Hand held instrument currently advertized as
  having on board, electronic controls.

33
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 systems stability
  is demonstrated

34
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

35
Option 3?
?
What belongs in this picture?
36
Option 3?
Every Instrument! Vitros Hitachi aca, SMAC, etc.
Prove stability for 60 days, run external QC once
per week
37
CLIA Equivalent QC (EQC)

• The director must consider the laboratorys
  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!

38
Uncle Sam

• Has Uncle Sam gone Crazy?

39
Uncle Sam

• Has Uncle Sam gone Crazy?
• Maybe or Maybe Not!

40
March 2004

• Does EQC and the U.S. regulations open a new era
  for
• new technologies
• or
• does EQC just cause confusion?

41
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

42
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?

43
The Devil is in the details

• EQC Qualified System External QC analyzed once
  per month or once per week.
• EQC-1 EQC-23

44
The Devil is in the Details
493.1282 Standard Corrective actions if
external QC resultsfail to meet the
laboratory's established criteria for
acceptability, all patient test results
obtainedsince the last acceptable test run must
be evaluated to determine if patient test results
have been adversely affected
45
Quality POCT Drivers?

• Manufacturers Building the perfect instrument
  to meet the needs of the testing environment

46
CLIAs new QC/EQC Requirements

• Have a two-year phase in
• Inspection
• Citations
• NO punitive activities

47
Manufacturers have EQOptions 1, 2, 3

• To be competitive in the marketplace, options 2
  and 3 DONT count

48
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.

49
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

50
..and

• Speaking of Lab Directors,
• Heerrrrrs Fritz !!!!!