1. UNIVERSITY OF WISCONSIN MEDICAL SCHOOL
Walk the Walk and Talk the Talk: Meeting the Inspector with Confidence!
Sharon S. Ehrmeyer, Ph.D.
UNIVERSITY OF WISCONSIN MEDICAL SCHOOL
MADISON, WI

2. Successful Strategy #1 Know your inspection agency’s requirements!

3. Regulatory reality
CLIA regulations must be met through accreditation with:
CLIA,
JCAHO, or
CAP

4. 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

5. 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.

6. 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

7. 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

8. JCAHO
Comprehensive Accreditation Manual (Pathology and Clinical Laboratory Services)
Beyond 2003

9. 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 15

10. 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 ( ) At a minimum, manufacturer’s instructions are followed. 15

11. 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 15

12. Waived Testing ( )
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 At minimum, manufacturer’s instructions are followed.
WT.1.5 Appropriate QC and test records are maintained.

13. Waived Testing ( )
WT Organization defines use of waived test results in patient care (definitively or only as a screen).
WT Organization identifies staff responsible for performing and supervising waived testing.
WT Staff performing tests have adequate, specific training and orientation to testing and demonstrate satisfactory levels of competence.
WT Approved policies and procedures governing testing processes are current and readily available.
WT QC checks, as defined by the organization, are conducted on each procedure.
WT Appropriate QC and test records are maintained.

14. WT -- Elements of performance (2004-2005)
WT 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 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.

15. WT -- Elements of performance (2004-2005)
WT 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

16. WT -- Elements of performance (2004-2005)
WT 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

17. WT -- Elements of performance (2004-2005)
WT 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

18. WT -- Elements of performance (2004-2005)
WT 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

19. 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

20. 2004 QC Standards (pre-publication)
Proficiency Testing
QC Each specialty and subspecialty has a documented QC program.
QC PT services used for specialty and subspecialty equal or exceed CLIA regulatory requirements
QC Lab maintains a cumulative record of PT participation and includes documented review and evaluation of each unsatisfactory PT result
QC Lab ensures PT testing is performed in the same manner as patient sample testing.
QC PT performance is maintained at an acceptable level.

21. 2004 QC Standards (pre-publication)
Quality Monitoring and Control Systems
QC Lab uses system for verifying accuracy and reliability of test results for tests not in regulatory PT.
QC Lab’s QC system validates methods used.
QC Lab uses system to evaluate and correlate relationship between results for same test performed with different methodologies/instruments or at different sites.
QC Lab’s QC system includes daily and periodic result surveillance by appropriate staff.
QC Lab takes remedial action for deficiencies identified by QC measures or authorized inspections and documents such actions.

22. 2004 QC Standards (pre-publication)
Quality Monitoring and Control Systems, cont.
QC Lab ensures QC results meet criteria for acceptability before reporting patient test results.
QC QC specimens are tested in same manner as patient samples.
QC Lab follows written guidelines for properly preparing, storing, dispensing, and periodically evaluating all reagents, including water, to ensure accurate, precise results.
QC Lab ensures reagents and solutions are completely and accurately labeled according to written guidelines.
QC Laboratory retains QC records as required by law.

23. 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) 15

24. JCAHO – 2004 and Beyond Checkout proposed standards at: www.jcaho.org
Also think about 100% compliance
100% of time
for patient safety 15

25. Successful Strategy #2 Apply the Regulations Identify Problems (Concerns) in YOUR laboratory1

26. How? Be objective Do periodic mock reviews CAP Interim Self Survey
JCAHO’s Preparation Guidelines
COLAs inspection checklist
Inspection Checklist
Consultants
Use tracker tools

27. 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)_________

28. 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?

29. 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?

30. 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?

31. 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?

32. 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?

33. 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?

34. 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?

35. Tracker Tools* to ID Problems
System to evaluate
Pre-analytic processes
Analytic processes
Post-analytic
*Anne Belanger, MA, MT(ASCP)
Consultant, Laboratory Accreditation

36. Tracker Tools* Specimen collection *Tools apply to all testing
Ordering
Specimen collection
Specimen processing
Sample testing
Resulting
*Tools apply to all testing

37. Tracker Tools Ordering Specimen collection
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?

38. 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?

39. 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?

40. Fix Problems Identified
Prioritize
Assign
Correct

41. Successful Strategy #3 Keep it simple; Work Smarter Don’t forget everything you learned by just focusing on the rules! 1

42. Don’t get caught in the trap! Avoid common citations1

43. Common citations Following manufacturer’s directions QC QA
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 15

44. 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

45. 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

46. 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

47. 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

48. 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

49. 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

50. 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

51. Documentation- policies/procedures
Administrative
Technical
Safety
General
Fire
Disaster
Chemical hygiene
Infection control

52. Documentation- policies/procedures
Specimen collection
Computer (including backup), as applicable
Procedure manuals
Inpatient and outpatient records
CQI activities

53. Documentation- records
Test validation protocols and records
Proficiency testing results (2 years)
Accuracy data, if not in PT
Quality control results
Method correlation records

54. 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

55. 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