Clia final regulations

1. Prof./Moustafa Rizk
Clinical pathology department
Faculty of Medicine, Alexandria
University

2. What is CLIAWhat is CLIA??
In 1988, media reports focused
attention on deficiencies in the
quality of services provided by
some of the nation's clinical
laboratories.
Clinical Laboratory Improvement
Amendments (CLIA) in 1988
established quality standards to
ensure the accuracy, reliability
and timeliness of patient test
results regardless of where the
test was performed.

3. CLIACLIA……
 The initial CLIA 88 regulation focused primarily
on the analytical processes.
 However , It was later stressed that the quality of
the total testing process must be monitored in
the addition to the precision and accuracy of the
analytical phase
 The final rule was published on January 24 2003 .
 Additional guidelines were published by
the centers of Medicare and Medicaid
Services (CMS) in January 2004.

4.  Applies to laboratories that examine human
specimens for the diagnosis, prevention, or
treatment of any disease or impairment of,
or the assessment of the health of, human
beings.
 Specifies performance requirements, based
on test complexity and risk factors related
to erroneous test results.
CLIACLIA……

5. CLIACLIA……
 Sets standards to improve quality in all
laboratory testing.
 Includes specifications for quality
control, quality assessment, patient test
management, personnel and proficiency
testing.

6. CLIA exceptionsCLIA exceptions......
CLIA doesCLIA does notnot apply to:apply to:
 Facilities only performing testing forFacilities only performing testing for
forensicforensic purposes.purposes.
 ResearchResearch labs that test humanlabs that test human
specimens but do not report patientspecimens but do not report patient
specific results for the assessment ofspecific results for the assessment of
the health of individual patients.the health of individual patients.

7.  CLIA certifiesCLIA certifies laboratorieslaboratories/ clinical/ clinical
laboratory practices,laboratory practices, notnot tests ortests or
individuals performing tests.individuals performing tests.

8. CLIA certification standards areCLIA certification standards are
based on test complexitiesbased on test complexities::
 WaivedWaived
 Moderate (including, PPM)Moderate (including, PPM)
 HighHigh

9. Waived TestsWaived Tests
 Any laboratory can perform thoseAny laboratory can perform those
tests as long as they follow thetests as long as they follow the
manufacturers directions.manufacturers directions.
 Simple lab examinations andSimple lab examinations and
procedures that pose no reasonableprocedures that pose no reasonable
risk of harm if performed incorrectly.risk of harm if performed incorrectly.

14. Moderate complexityModerate complexity
Including the subcategory of Provider-
Performed Microscopy Procedures
(PPM):
mostly involve testing performed
in physician office labs or which is
essential for immediate patient care.

16. High complexityHigh complexity
 Risk of erroneous results is
substantial because testing
methodologies are often complex,
usually involving multiple steps ,
and are characterized by…

17. High Complexity TestingHigh Complexity Testing
 Complicated reagent preparation .Complicated reagent preparation .
 Complicated / extensive maintenance andComplicated / extensive maintenance and
troubleshooting.troubleshooting.
 Quality control requiring special materialsQuality control requiring special materials
and analyst interpretation.and analyst interpretation.
 May require a comprehensive understandingMay require a comprehensive understanding
of the method, instrumentation , physiology,of the method, instrumentation , physiology,
interpretation of data and clinicalinterpretation of data and clinical
significance of the result.significance of the result.
 Interpretation of test results requiresInterpretation of test results requires
extensive knowledge of factors that canextensive knowledge of factors that can
influence test results.influence test results.

18. High Complexity TestingHigh Complexity Testing
High complexity tests (Non waived) require
more knowledge and training to
perform/interpret test results, they have the
most stringent CLIA standards.
Non Waived laboratories are subject to the
complete CLIA regulations and must be
inspected periodically by the government or
by certain professional organizations that
are deemed to have standards at least as
stringent as the CLIA requirements

23. Non- waived labs must apply forNon- waived labs must apply for
CLIA certification and fulfill THECLIA certification and fulfill THE
major CLIA quality requirementsmajor CLIA quality requirements
 PersonnelPersonnel
 Quality ControlQuality Control
 Proficiency TestingProficiency Testing
 Patient Test ManagementPatient Test Management
 Quality AssessmentQuality Assessment

24. Quality RequirementsQuality Requirements::
 Personnel qualifications and
responsibilities for each personnel
position in a CLIA lab.

25. CLIA’s detailed personnel requirements for
laboratories performing high
complexity testing
The laboratory must have a director who meets the
qualification requirements of this subpart and
provides overall management and direction .
The laboratory director must be qualified to manage
and direct the laboratory personnel and
performance of high complexity tests and must
be eligible to be an operator of a laboratory .
The laboratory director must possess a current
license as a laboratory director issued by the
State in which the laboratory is located .
The laboratory director must be a doctor of
medicine .

26. Quality Requirements
 Calibration means a process of testing and
adjusting an instrument or test system to
establish a correlation between the measurement
response and the concentration or amount of the
substance that is being measured by the test
procedure.
 Calibration verification means the assaying of
materials of known concentration in the same
manner as patient samples to substantiate the
instrument or test system's calibration
throughout the reportable range for patient test
results.

27. Quality Requirements
Quality ControlQuality Control
1- Internal1- Internal control procedures thatcontrol procedures that
focus on monitoring single lab.focus on monitoring single lab.
 Daily monitoring of theDaily monitoring of the precisionprecision andand
accuracyaccuracy of the analytical method.of the analytical method.
 In practice ,internal QC procedures onlyIn practice ,internal QC procedures only
detectdetect changeschanges in performance betweenin performance between
thethe presentpresent operation and theoperation and the stablestable
operation that was characteristic during theoperation that was characteristic during the
base line period when the analytical methodbase line period when the analytical method
was thought to be operating properly .was thought to be operating properly .

28. Quality RequirementsQuality Requirements
 Although the procedures detectAlthough the procedures detect
systematic and random errors ,the onlysystematic and random errors ,the only
systematic errors detected are thosesystematic errors detected are those
changes from the original baseline.changes from the original baseline.
 If the method actually had someIf the method actually had some
undetected systematic errors during theundetected systematic errors during the
baseline period ,those systematic errorsbaseline period ,those systematic errors
would be included in the mean that waswould be included in the mean that was
used to calculate the control limits forused to calculate the control limits for
the procedure.the procedure.
 Thus only systematic changes from thisThus only systematic changes from this
original mean will be detected byoriginal mean will be detected by
internal QC procedures.internal QC procedures.

29. QualityQuality Requirements
 Initial method evaluation studies are
essential to ensure that systematic errors
are not present before the baseline period
and the determination of the mean and
the control limits.
 The accuracy of the method should be
initially established by comparison with
other analytical methods and should
continue to be monitored by comparison
with other analytical methods.

30. Quality Requirements
 Ongoing comparison -of-methods studies
are desirable to ensure that systematic
errors do not slowly increase and go
undetected by internal QC procedures.
 These ongoing comparison studies are
provided by the external QA programs,
which in turn form the basis for proficiency
testing programs.

31. Quality Requirements
Proficiency Testing (PT) :
 Periodic testing, by laboratories, of
samples received from a PT program.
The PT program grades the samples,
based on the determined value of the
sample, and reports the results to the
laboratory .PT is important because it
is a tool the laboratory can use to
verify the accuracy of their testing.

32. Quality Requirements
Patient Test Management
Record keeping system
Patient identification
Confidentiality

33. Quality Requirements
Quality Assessment
Ongoing, overall plan to monitor and
ensure accurate, timely test results.

34. Validation and verification
The quantitative management of quality requires that
performance be assessed and compared to the implied
needs of customers and the defined requirements of
regulators and/or accreditors. This aspect of assessing
conformance to needs and requirements is described as:
• Validation. Action [or process] of proving that a procedure,
process, system, equipment, or method used works as
expected and achieves the intended result.
• Verification. The confirmation by examination and provision
of objective evidence that specified requirements have
been fulfilled.

35.  In Theory the total error is the
Random error + the systematic
error,
 In practice Random error is
represented by the SD or the CV %,
on the other hand the systematic
error is represented by the Bias of
the Method.

36.  The total error is compared to what
is called Total Error Allowed (TEa) to
check the performance of the
method.

37. TEa can be derived from CLIA and CAP
providing fixed limits
Total Error Limits (TEa) specify how far
any result can vary from the target
value before reaching an unacceptable
Risk of Significant Error
Total Error (TE) is a function of method
inaccuracy and imprecision

38. How to Calculate the Total
Error
 The calculation of total error requires four
valid numbers:
• Target value (Peer Mean)
• TEa limit (CAP Survey Limit or CLIA Limit)
• Mean (Customer’s historical data, Actual)
• SD (Customer’s operating SD)

39.  The first step is to verify
that these four numbers
are correct.

40. If you have the four numbers, you can
use any of the two following
equations:
TE = Bias + 2 SD
%TE = %bias + 2 CV

41.  If the calculated total error is within
the specified TEa limits, then the
method is producing clinically
acceptable results.
 If the performance of the method
exceeds total error limits, the cause
must be investigated and corrective
action initiated.

42. Example 1
GLU Target Actual SD
275 269 4.5
TEa 6mg/dl or 10% (as per CAP/CLIA Limit)
So the TEa in this case will be 10% of your target
value = 275 * 10% = 27.5
The Bias will be 275 - 269 = 6
The Total Error = Bias + 2 sd. which equals
6 + 9 = 15
TE is less than TEa (15 < 27.5) the method is
within the acceptable performance

43. ALP Target Actual 1SD
260 320 10
TEa 30% (CAP or CLIA limit)
So the TEa in this case will be 30% of your target
value
TEa= 260 * 30% =78
The Bias will be 320 - 260 = 60
Total Error = Bias + 2 SD = 60 + 20 = 80
TE is more than TEa (80 > 78) the method is
outside the acceptable performance criteria and
needs a corrective action

44. In the CLIA Final Rule, the term quality
assessment is used to broadly encompass
the concepts and practices of validation
and verification, as well as related terms
such as evaluation, audit, etc.
Quality assessment should involve sound
scientific methodology and data analysis
(statistics) to provide an objective
comparison of the measured or observed
performance to the defined quality goals
and requirements.

45. Identify the impact of the
regulations on your laboratory
 Navigate the complexities of the new complexity
categories: waived, non-waived, moderate, and
high complexity testing
 Identify method validation requirements that
apply to new methods in your laboratory
 Learn how Sigma metrics can ease your decisions
on method acceptability
 Target the issues, guidelines and probes that
influence the inspectors
 Evaluate the implications of "equivalent QC
procedures"
 Understand how to do the right QC right

46.  CLIA Final Rules for Quality Systems is
more than a compliance manual. It
identifies the specific regulations, then
takes the discussion one step further, to
the reasoning and logic that shaped CLIA.
Readers will gain not only a grasp on the
regulatory details, but a broader
understanding of the key concepts of
quality control, method validation, and
even Six Sigma quality management.

48. Certification of Registration
 an initial certificate provided to all labs
except those performing only waived
and/or Provider Performed Microscopy
Procedures (PPM) procedures
 valid for no more than two years or until
such time as an inspection to determine
program compliance can be conducted,
whichever is shorter

49. CLIA Certification Types (Cont.(
Certificate for Provider-Performed
Microscopy Procedures (PPM)
tests largely performed in Physician
Office Labs
Certificate of Accreditation
for labs seeking certification via
accreditation agency requirements
deemed by CMS to be equal to, or
more stringent than CLIA