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

Walk the Walk and
Talk the Talk:
Meeting the Inspector
with Confidence!
Sharon S. Ehrmeyer, Ph.D.
UNIVERSITY OF WISCONSIN MEDICAL SCHOOL
MADISON, WI
Successful Strategy
#1
Know your inspection
agency’s requirements!
Regulatory reality
CLIA regulations must be met
through accreditation with:
 CLIA,
 JCAHO,
 CAP
or
General Regulatory Requirements
 Follow
manufacturer’s protocols
 Validate method before routine use
 Accuracy,
 Have
precision, reportable range, etc.
authorized operators
 Initial
(documented) training and on-going
competency assessment
 Include
patient and operator identification
 Monitor instrument functions
General Regulatory Requirements
Perform required maintenance
 Perform and evaluate QC at appropriate
intervals
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Perform corrective actions
Provide an audit trail

From testing to patient record
Participate in regulatory proficiency testing
 Document all information
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QC, QA checks, PT results, maintenance, etc.
Who’s on first?
 What
regulations to follow; who inspects
depends on CLIA certificate arrangement:
 JCAHO
accreditation
– Accepts CAP and COLA inspections
– Reinspects waived POCT every 3 years
 CAP
accreditation
– CAP must inspect
 CMS
for CLIA compliance
– Sites not seeking specific accreditation
CLIA’03 Final QC Regulations

Good news!!
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Allows one survey cycle (2 years) to:
– Permit labs to comply
– CMS to develop revised surveyor/lab guidelines
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Bad news!!
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No comments solicited
Regulation is final
Still not complete; other subparts will follow
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Judy Yost, CMS 2003
JCAHO
Comprehensive Accreditation
Manual (Pathology and Clinical
Laboratory Services)
Beyond 2003
JCAHO – 2004 and beyond
Draft of proposed standards at
www.jcaho.org
Goal with revisions:
Eliminate redundancies
Reduce documentation and paperwork
Focus survey process on patient safety and
health care quality
JCAHO – 2004 and beyond
JCAHO’s new accreditation model:
More data driven
Less predictable
More customized to individual organization
Fewer standards, but not reduced requirements
Standards’ wording revised to be better understand
Change in basic format
– Intent statement replaced with rationale and measurable
characteristic (element of performance, e.g., there is a written
policy that defines QC)
Some standards are now “elements of performance”
– WT.1.4.1 (2002-2003) At a minimum, manufacturer’s
instructions are followed.
JCAHO – 2004 and beyond
JCAHO’s new survey process – Shared
Visions-New Pathways:
Scoring changed from a 5 to a 3-point process
No percentage score
Focus on lab functions – pre- through postanalytical
Waived Testing (2002-2003)
WT.1 Organization defines use of waived test results in patient
care (definitively or only as a screen).
WT.1.1 Organization identifies personnel responsible for performing
and supervising waived testing.
WT.1.2 Personnel performing tests have adequate, specific training
and orientation to perform the tests, and demonstrate satisfactory
levels of competence.
WT.1.3 Policies and procedures governing specific testing-related
processes are current and readily available.
WT.1.4 QC checks, as defined by organization, are conducted on each
procedure.
WT.1.4.1 At minimum, manufacturer’s instructions are followed.
WT.1.5 Appropriate QC and test records are maintained.
Waived Testing (2004-2005)
WT.1.10 -- Organization defines use of waived test results in
patient care (definitively or only as a screen).
WT.1.20 -- Organization identifies staff responsible for
performing and supervising waived testing.
WT.1.30 -- Staff performing tests have adequate, specific
training and orientation to testing and demonstrate
satisfactory levels of competence.
WT.1.40 -- Approved policies and procedures governing
testing processes are current and readily available.
WT.1.50 -- QC checks, as defined by the organization, are
conducted on each procedure.
WT.1.60 -- Appropriate QC and test records are maintained.
WT -- Elements of performance (20042005)
WT.1.10 -- Organization defines use of waived
test results in patient care (definitively or only
as a screen).
 If
test is used for screening, then confirmatory test
is specified in procedure, if required WT.1.20 -Organization identifies staff responsible for
performing and supervising waived testing.
 Each identified may be employees of the
organization, contracted staff, or employees of a
contracted service.
WT -- Elements of performance (20042005)
WT.1.30 -- Staff performing tests have adequate, specific
training and orientation to testing and demonstrate
satisfactory levels of competence.
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Competency assessments are based on frequency of staff
performance of testing, technical background and skills,
complexity of method and consequence of inaccurate results
Assessment of skills include at least one of following
– Performing test on unknown sample
– Supervisory or qualified person observe routine work
– Monitor QC performance
WT -- Elements of performance (20042005)
WT.1.40 -- Approved policies and procedures governing
testing processes are current and readily available.
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Specimen collection, ID, and appropriate required labeling
Specimen preservation, as appropriate
Instrument calibration
QC and remedial actions
Equipment performance evaluation
Test performance
WT -- Elements of performance (20042005)
WT.1.50 -- QC checks, as defined by the organization, are
conducted on each procedure.
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Written QC plan that specifies how procedures will be controlled
for quality, establishes timetables, and explains rationale
QC checks conducted as specified in plan
– For glucose, 2 levels of QC are run each day of patient testing
– For other methods, QC is based on how test is used, reagent stability,
manufacturer’s recommendations, organizations experience with test,
currently accepted guidelines
– At minimum, manufacturers’ instructions are followed
WT -- Elements of performance (20042005)
WT.1.60 -- Appropriate QC and test records are
maintained.
 All
QC results documented
 All test results are documented
 QC records, instrument problems, and patient results
correlated
 Functional audit trail maintained
QC – JCAHO (2002-2003)
(QC.1)
(QC.1.2)
(QC.1.3)
(QC.1.4)
(QC.1.5)
Documented QC program
Validation of methods
Daily surveillance of results
Perform / document corrective actions
Review QC results before reporting
results
(QC.1.6) Follow manufacturer’s reagent
guidelines
2004 QC Standards (pre-publication)
Proficiency Testing
QC.1.10 -- Each specialty and subspecialty has a
documented QC program.
QC.1.20 -- PT services used for specialty and subspecialty
equal or exceed CLIA regulatory requirements
QC.1.30 -- Lab maintains a cumulative record of PT
participation and includes documented review and
evaluation of each unsatisfactory PT result
QC.1.40 -- Lab ensures PT testing is performed in the same
manner as patient sample testing.
QC.1.50 -- PT performance is maintained at an acceptable
level.
2004 QC Standards (pre-publication)
Quality Monitoring and Control Systems
QC.1.60 --Lab uses system for verifying accuracy and
reliability of test results for tests not in regulatory PT.
QC.1.70 -- Lab’s QC system validates methods used.
QC.1.80 -- Lab uses system to evaluate and correlate
relationship between results for same test performed with
different methodologies/instruments or at different sites.
QC.1.90 -- Lab’s QC system includes daily and periodic
result surveillance by appropriate staff.
QC.1.100 -- Lab takes remedial action for deficiencies
identified by QC measures or authorized inspections and
documents such actions.
2004 QC Standards (pre-publication)
Quality Monitoring and Control Systems, cont.
QC.1.110 -- Lab ensures QC results meet criteria for
acceptability before reporting patient test results.
QC.1.120 -- QC specimens are tested in same manner as
patient samples.
QC.1.130 -- Lab follows written guidelines for properly
preparing, storing, dispensing, and periodically evaluating all
reagents, including water, to ensure accurate, precise results.
QC.1.140 -- Lab ensures reagents and solutions are completely
and accurately labeled according to written guidelines.
QC.1.150 -- Laboratory retains QC records as required by law.
JCAHO – QC standards (2004 and
beyond)
Like for WT, each standard has elements of
performance for guidance in meeting the
standard
Specialty and subspecialty sections to follow
(depends on testing performed)
Clinical chemistry
Hematology and coagulation
Clinical microscopy (urinalysis)
JCAHO – 2004 and Beyond
Checkout proposed standards at:
www.jcaho.org
Also think about 100% compliance
100% of time
for patient safety
Successful Strategy
#2
Apply the Regulations
Identify Problems (Concerns) in
YOUR laboratory
How?
 Be
objective
 Do periodic mock reviews
 CAP
Interim Self Survey
 JCAHO’s Preparation Guidelines
 COLAs inspection checklist
 Inspection Checklist
 Consultants

Use tracker tools
Mock Inspection – Gen. Information

Is testing performed under an appropriate CLIA
certificate?
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Central Laboratory or other (specify)____________
Type of certificate - waived, mod. or high complexity
Expiration date ________________
Director named on certificate _________________
Which agency inspects?
–
–
–
–
–
JCAHO
CAP
COLA
CMS (CLIA)
Other (specify)_________
Mock Inspection -- QA
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QA Plan implemented and available to view?
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Director and supervisor signed off / approved?
Monitors assure total quality care?
Documentation of problems/resolutions?
Accuracy verified for all analytes?
 Results correlated?
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with other methods / instruments
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Complaints and deficiencies logged and corrected?
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QA activities / reports show quality is built in?
Mock Inspection -- Personnel
 Director/supervisor
meet CLIA qualifications
and applicable state/local laws?
 Testing personnel authorized for specific
testing?
 Received
adequate training?
 Assessed, on a defined interval, for continued
competency?
 Records, including training and competency
assessment, maintained?
Mock Inspection -- Procedure manual
 The
most current PM is available to staff?
 Dated
when put in place?
 Updated with the latest product inserts?
 Reviewed and signed by the Director or designee
initially (and every 2 years)?
 Old PMs for discontinued methods retained for at
least 2 years?
 Testing
personnel are familiar with its
content?
Mock Inspection -- QC
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Established QC program that describes:
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frequency of QC and number of controls analyzed?
acceptable limits?
documentation of QC results?
corrective action for values outside acceptable limits?
corrective action for unacceptable controls and
documentation?
review of QC data including review of any corrective
action reports?
Mock Inspection -- PT
 Enrolled
tests?
 PT
in regulatory PT for the regulated
results reviewed and review documented
(signed and dated)?
 Each failure investigated and corrective actions
documented?
 Records maintained for appropriate time?
Mock Inspection -- Reagents
 Kept
in original container?
 Stored
as directed by manufacturer?
– If a specific temperature range is required,
temperature must be monitored.
 Not
used beyond indicated expiration dates?
Mock Inspection -- Lab safety
 Safety
 Does
manual available to staff?
it contain:
– general institutional requirements?
– instructions to minimize the risk of exposure to
HIV, hepatitis, etc.?
– fire prevention and control?
– electrical safety?
– hazardous waste disposal including sharp/needle
disposal?
– internal and external disaster plans?
Tracker Tools* to ID Problems
System to evaluate
 Pre-analytic processes
 Analytic processes
 Post-analytic
*Anne Belanger, MA, MT(ASCP)
Consultant, Laboratory Accreditation
Tracker Tools*
 Ordering
 Specimen collection
 Specimen processing
 Sample testing
 Resulting
*Tools apply to all testing
Tracker Tools
 Ordering
 Right test ordered on right patient?
 How does the order get to the laboratory?
 Order is clear and legible?
 Polices and procedures for specimen collection?
 Specimen collection
 Sterile technique used to draw blood?
 Blood preserved properly in appropriate
container?
 Blood collected at correct time?
 Specimen labeled adequately?
Tracker Tools
Sample testing
 Adequate technical procedures available?
 Analysts attested to their familiarity with these?
 Specimen integrity and identification
maintained?
 Specimen tested in a timely manner?
 Equipment maintained per manufacturer's
instructions?
 QC performed and within acceptable limits?
 Corrective action taken for unacceptable QC
results?
 Sample rerun as necessary?
 Results verified?
Tracker Tools
 Resulting
Correct result noted in report?
Result legible?
Appropriate reference intervals included?
Pertinent comments noted (e.g., hemolysis)?
Result reported to doctor in a timely fashion?
Fix Problems Identified
Prioritize
Assign
Correct
Successful Strategy
#3
Keep it simple; Work Smarter
Don’t forget everything you
learned by just focusing on the
rules!
Don’t get caught in the trap!
Don’t get caught in the trap!
Avoid common citations
Common citations
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Following manufacturer’s directions
QC
– Perform at appropriate frequency
– Corrective actions for out-of-control situations
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QA
– Have a plan
– Monitor for effectiveness
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2X / year, comparisons and accuracy assessments
Personnel competency
Proficiency testing
– Participation
– Review of results
– Corrective actions
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Documentation
Fail-safe Inspection Tips
Things that should never occur:
 Dirty laboratory
 Messy storage areas
 Unsafe practices
– Pre through post-analytical
 Uncorrected old citations
– Always have a plan!
 Staff who are not in the loop
ADVICE FROM INSPECTED LABS

Know and understand inspecting agency’s
regulations

Follow to the “nth” degree
Have documentation for everything
 Have all manuals, records and files current
and understandable
 Have an overall plan that states the lab’s
approach to QA
 Educate the staff -- everyone is on the same
page
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ADVICE FROM INSPECTED LABS
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With inspectors:
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Be courteous
Be honest
– Don’t volunteer extra information, but don’t get “dingy”
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Be ready to explain the why and how
– Don’t argue, explain in writing
– With areas of concern, ask for suggestions
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Be professional
Be confident; act confident
INSPECTION DOs AND DON’T
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Don’t procrastinate
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Paperwork, personnel reviews, records, etc.
Do maintain an up-to-date QA program
 Do come to the table prepared
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Prepare everyone
Don’t operate a “sloppy ship”
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Follow all rules – always
Make compliance a requirement for continued
employment
INSPECTION DOs AND DON’T

Don’t delegate inspection duties to unprepared
staff

Unknowledgeable staff communicating with the
inspector is a disaster
Do have an alternative plan if the assigned staff
member (to be with inspector) becomes
unavailable
 Do present an organized front
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Have “private space” for inspector to review materials
and documentation
Organized documentation
Document, Document, Document
Inspectors don’t want to see that you have the ability to
produce quality results, they want:
PROOF OF A QUALITY OPERATION
Documentation must be organized and easy to
understand
Documentation -- Personnel
Job descriptions
Personnel records (including licenses as
applicable)
 OSHA bloodborne pathogen testing
 Hepatitis B vaccination record or declination
form
 Immunization/health/accident/incident records
Orientation/in-service/cont. education records
Performance evaluations
Orientation and competence assessment
Documentation- policies/procedures
Administrative
Technical
Safety
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General
Fire
Disaster
Chemical hygiene
Infection control
Documentation- policies/procedures
Specimen collection
Computer (including backup), as
applicable
Procedure manuals
Inpatient and outpatient records
CQI activities
Documentation- records
Test validation protocols and records
Proficiency testing results (2 years)
Accuracy data, if not in PT
Quality control results
Method correlation records
Documentation- records
 Function checks and calibration,
maintenance, and repair records for all
equipment
 Temperature records
 only when relevant
– regents must be stored at specified temperature
 Corrective action records for PT, QC
After the inspection
Final decision usually up to regulator's
oversight function, e.g., its board
Review all citations
Perform follow up per regulator's guidelines
 Prepare plan of correction
 Implement needed corrections
 Provide evidence to regulator per guidelines
Keep inspection ready