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Walk the Walk and Talk the Talk:
Meeting the Inspector with Confidence!
Sharon S. Ehrmeyer, Ph.D.UNIVERSITY OF WISCONSIN MEDICAL SCHOOL
MADISON, WI
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Successful Strategy#1
Know your inspection agency’s requirements!
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CLIA regulations must be met through accreditation with:
CLIA,JCAHO, orCAP
Regulatory reality
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General Regulatory Requirements
Follow manufacturer’s protocols Validate method before routine use
Accuracy, precision, reportable range, etc. Have authorized operators
Initial (documented) training and on-going competency assessment
Include patient and operator identification Monitor instrument functions
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General Regulatory Requirements
Perform required maintenance Perform and evaluate QC at appropriate
intervals Perform corrective actions
Provide an audit trail From testing to patient record
Participate in regulatory proficiency testing Document all information
QC, QA checks, PT results, maintenance, etc.
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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
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CLIA’03 Final QC Regulations
Good news!! Allows one survey cycle (2 years) to:
– Permit labs to comply– CMS to develop revised surveyor/lab guidelines
Bad news!! No comments solicited Regulation is final Still not complete; other subparts will follow
Judy Yost, CMS 2003
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JCAHO Comprehensive Accreditation
Manual (Pathology and Clinical Laboratory Services)
Beyond 2003
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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
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JCAHO – 2004 and beyondJCAHO’s new accreditation model:
More data drivenLess predictableMore customized to individual organizationFewer standards, but not reduced requirementsStandards’ wording revised to be better understandChange 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.
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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 post-
analytical
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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.
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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.
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WT -- Elements of performance (2004-2005)
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.
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WT -- Elements of performance (2004-2005)
WT.1.30 -- Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence. 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
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WT -- Elements of performance (2004-2005)
WT.1.40 -- Approved policies and procedures governing testing processes are current and readily available. Specimen collection, ID, and appropriate required labeling Specimen preservation, as appropriate Instrument calibration QC and remedial actions Equipment performance evaluation Test performance
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WT -- Elements of performance (2004-2005)WT.1.50 -- QC checks, as defined by the organization, are
conducted on each procedure. 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
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WT -- Elements of performance (2004-2005)
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
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QC – JCAHO (2002-2003)
(QC.1) Documented QC program(QC.1.2) Validation of methods(QC.1.3) Daily surveillance of results (QC.1.4) Perform / document corrective actions (QC.1.5) Review QC results before reporting
results(QC.1.6) Follow manufacturer’s reagent
guidelines
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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.
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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.
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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.
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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)
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JCAHO – 2004 and Beyond
Checkout proposed standards at:www.jcaho.org
Also think about 100% compliance 100% of time
for patient safety
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Successful Strategy#2
Apply the Regulations
Identify Problems (Concerns) in YOUR laboratory
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How? Be objective Do periodic mock reviews
CAP Interim Self Survey JCAHO’s Preparation Guidelines COLAs inspection checklist Inspection Checklist Consultants
Use tracker tools
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Mock Inspection – Gen. Information Is testing performed under an appropriate CLIA
certificate? 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)_________
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Mock Inspection -- QA
QA Plan implemented and available to view? Director and supervisor signed off / approved? Monitors assure total quality care? Documentation of problems/resolutions?
Accuracy verified for all analytes? Results correlated?
with other methods / instruments Complaints and deficiencies logged and corrected? QA activities / reports show quality is built in?
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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?
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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?
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Mock Inspection -- QC
Established QC program that describes: 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?
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Mock Inspection -- PT
Enrolled in regulatory PT for the regulated tests? PT results reviewed and review documented
(signed and dated)? Each failure investigated and corrective actions
documented? Records maintained for appropriate time?
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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?
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Mock Inspection -- Lab safety
Safety manual available to staff? Does 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?
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Tracker Tools* to ID Problems
System to evaluate Pre-analytic processes Analytic processes Post-analytic
*Anne Belanger, MA, MT(ASCP)Consultant, Laboratory Accreditation
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Tracker Tools*
Ordering Specimen collection Specimen processing Sample testing Resulting
*Tools apply to all testing
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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 collectionSterile technique used to draw blood?Blood preserved properly in appropriate
container?Blood collected at correct time?Specimen labeled adequately?
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Tracker ToolsSample 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?
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Tracker Tools
ResultingCorrect result noted in report?Result legible?Appropriate reference intervals included?Pertinent comments noted (e.g., hemolysis)?Result reported to doctor in a timely fashion?
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Fix Problems Identified
PrioritizeAssignCorrect
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Successful Strategy#3
Keep it simple; Work Smarter
Don’t forget everything you learned by just focusing on the
rules!
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Don’t get caught in the trap!Avoid common citations
Don’t get caught in the trap!
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Common citations Following manufacturer’s directions QC
– Perform at appropriate frequency– Corrective actions for out-of-control situations
QA– Have a plan– Monitor for effectiveness
2X / year, comparisons and accuracy assessments Personnel competency Proficiency testing
– Participation– Review of results– Corrective actions
Documentation
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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
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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
With inspectors: Be courteous Be honest
– Don’t volunteer extra information, but don’t get “dingy” Be ready to explain the why and how
– Don’t argue, explain in writing – With areas of concern, ask for suggestions
Be professional Be confident; act confident
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INSPECTION DOs AND DON’T
Don’t procrastinate Paperwork, personnel reviews, records, etc.
Do maintain an up-to-date QA program Do come to the table prepared
Prepare everyone Don’t operate a “sloppy ship”
Follow all rules – always Make compliance a requirement for continued
employment
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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 Have “private space” for inspector to review materials
and documentation
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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
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Documentation -- PersonnelJob descriptionsPersonnel 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 recordsPerformance evaluationsOrientation and competence assessment
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Documentation- policies/procedures
Administrative Technical Safety
General Fire Disaster Chemical hygiene Infection control
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Documentation- policies/procedures
Specimen collection Computer (including backup), as
applicable Procedure manuals Inpatient and outpatient records CQI activities
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Documentation- records
Test validation protocols and records Proficiency testing results (2 years) Accuracy data, if not in PT Quality control results Method correlation records
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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
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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