1. The Joint Commission Laboratory Program- What’s New
Jennifer Rhamy
Executive Director

2. What’s New at The Joint Commission
Me- and excited to be working with all of you
Lab STAT News monthly s
Recent customer survey to hear voice of the customer
Dedicated account executives for laboratory
Increased alliance of the hospital and lab programs

3. Ongoing Lab Focus quarterly newsletter Lab Advantage program
Discounted program for bundled proficiency testing, ASCP educational programs, and The Joint Commission accreditation.
See for more information

4. Coming Soon
Crosswalk of The Joint Commission and CLIA standards available as part of e-dition
Development of the next revision of Laboratory Accreditation Standards and working collaboratively with ASCP to identify volunteers
2010 Laboratory Accreditation Overview
Leading Practices Database
eApplication for lab in 2011
Deeming process in late 2010

5. EXAMPLE: Crosswalk Display for Home Health
CMS Requirements—may include multiple CMS areas
Joint Commission EP

6. EXAMPLE: Crosswalk: Ambulatory Care

7. Come meet with us! Will have a booth at AACC, CLMA, and ASCP this year
Speaking at SEABB
Another free audio conference next fall
Other audio conferences and publications listed on the web site

8. Summary We want to hear from you
Initiatives are being driven by communications out to the accredited facilities or getting feedback
Concentrating on standards and accreditation process improvements in 2010

9. Tips For A Successful Survey
use these colors
Tips For A Successful Survey
Kathie Steffens
Field Director

10. Documents and Information
Test Menu and Instruments Used
Tests that you perform in your laboratory
Total Test Volume for each CLIA
ABG =1 procedure
pH, pCO2, pO2 = 3 tests
CLIA Certificate(s)
For all laboratory services provided on-site.

11. Documents and Information
Environmental and Safety Inspections
Safety Committee Reports
Hazardous Waste Disposal Manifests
Infection Control Policy and Processes
Performance Improvement
Data gathered
Data analysis and conclusions
Improvements Implemented
On-going monitoring

12. Documents and Information
Proficiency Testing for last 6 events
Copies (hard copy or electronic) of original test performance
Procedure for handling and assessing PT
Attestation signed by testing personnel
Review of PT results from vendor
Investigation and corrective action of all unacceptable results.

13. Documents and Information
Policy and Procedures
Do not need to move to a central location
Quality Control Data
Last 24 months accessible
Calibration and Calibration Verification
Performance over last 24 months accessible

14. Documents and Information
Maintenance Records
Last 24 months accessible
Personnel Files
Have someone available who knows HR file system.
Validation of educational requirements
State licenses as applicable
Competency Assessment Records
Current and last annual assessment

15. Tracer Activity
Patient tracers cover all specialties and subspecialties across the period from the last full survey
May be less than 24 months.
Labs converting from another accreditor
are reviewed for prior four months activity, except for PT which is for 24 months.

16. Tips for Survey Know how to access information.
If on paper, how to retrieve if
information is in storage
If electronic, what program(s) will
you need to access for historic data
If using EMR, who will be needed to access patient information

17. Tips for Survey Encourage staff to openly participate.
If staff doesn’t understand what the surveyor wants, ask the surveyor to explain in more detail.
If staff doesn’t know the answer to a question, it’s okay to say they don’t.
Tell the surveyor how your lab complies with standard within your lab.
Every lab doesn’t comply the same way.
Have open discussion about standards.

18. Tips for Survey Point-of-Care Sites Off-site locations
Inform all staff that they will be asked to participate in survey.
Off-site locations
Inform all staff of same information that will be required for their survey activity.
Staff availability
Let the surveyor know who might be available only on certain days.

19. 2010 Standards - Tips & Topics
Megan E. Sawchuk, MT(ASCP)
Associate Director, Standards Interpretation Group

20. Standards Applicability
Standards are applicable based on:
Definition of a lab test as regulated by CLIA
Exceptions
Multiple test complexity levels
Multiple laboratory accreditors
Multiple health care accreditation programs, e.g. hospital, ambulatory, lab

21. Which organization standards apply to laboratory services?
Accreditation programs include:
Hospital
Critical Access Hospital
Ambulatory
Office Based Surgery
Long Term Care
Home Care
Behavioral Health
Manuals include complementary “core” standards
Similar across all The Joint Commission accreditation programs
Standards often met with organizational policies

22. Core standards chapters
Accreditation Participation Requirements (APR)
Environment of Care (EC)
Emergency Management (EM)
Human Resources (HR)
Infection Control (IC)
Information Management (IM)
Leadership (LD)
National Patient Safety Goals (NPSG)
Performance Improvement (PI)
Transplant Safety (TS)
Waived Testing (WT)

23. Organizational standards applicable to laboratory services
Waived testing: APRs, NPSGs, LD , WT chapters
Non-waived testing: Other standards could be reviewed incidental to hospital tracer, e.g. safety, infection control, general policies (specimen collection & transport)
No technical testing requirements would be surveyed
Other related clinical and hospital requirements, e.g. transfusion medicine
Many related to Medicare’s Conditions of Participation (CoPs), e.g. 42 CFR Hospital Laboratory Services

24. Tip: Hospital standards related to blood administration
EC Emergency power for blood storage systems
HR Special training provided for transfusion administration
MS Medical staff involved in PI activities for blood & blood use
PC Transfusions administered per law & medical staff policy
PC HIV/HCV Notification (Look back) policies
PC Transfusion administration equipment is available for operative and other high-risk procedures
PI Organization collects data on blood and blood use, and all reported and confirmed transfusion reactions
RI Informed consent process
NPSG Two identifiers used to ID patient for transfusion
NPSG Two persons verify patient ID and product for transfusion
UP  Standardized pre-op verification list, including blood product availability (and other laboratory reports)

25. Tip: Hospital standards related to laboratory services
HR Testing personnel meet the qualifications defined in the CLIA regulations
IC Laboratory resources are provided to support infection prevention and control program
IC Cleaning and disinfection of bedside point-of-care instruments, e.g. glucose meters
LD All laboratory services have CLIA certificates and licenses required by regulation
LD  Pathology and clinical laboratory services are provided (essential service) to meet patient needs
LD Performance management of contracted laboratory services; maintaining evidence of CLIA compliance for reference and contract laboratory services
MM Necessary laboratory results are available to those managing a patient’s medications

26. Tip: Hospital standards related to laboratory services
MS Medical staff involved in PI activities for autopsies
MS – MS Credentialing and privileging of licensed independent practitioners (LIPs) providing interpretive reports, e.g. pathologists performing histopathology
MS – MS Ongoing & Focused Practitioner Performance Evaluation (OPPE & FPPE), applies to the above LIPs
NPSG Reporting of critical results (clinical reporting intervals, such as nurse to physician, not those of the main laboratory)
NPSG Baseline and ongoing testing for anticoagulation therapy provided per written protocol/policy approved by medical staff
PC Surgical tissue specimen policies, e.g. gross only, exceptions to submission to pathology, specimen handling
TS – TS Tissue storage and issuance (if lab oversees)
WT – WT   Waived Testing

27. The Joint Commission Laboratory Accreditation Program
Laboratory application submitted to The Joint Commission
Survey every two years led by an MT/CLS surveyor (Masters prepared or managerial background)
Only non-waived services can be accredited
Could be main lab, POCT only, or both
Organization could have more than one laboratory accreditor, e.g. main lab CAP, POCT The Joint Commission
Having Joint Commission hospital accreditation does not mean the laboratory services are also Joint Commission accredited
Survey every three years for hospitals
Team of RN, MD, LSC, Administrator
No technical elements of testing are reviewed

28. Which standards apply if there are Joint Commission accredited non-waived laboratory services?
Laboratory standards manual
Non-waived testing: All chapters apply, except WT
Core chapters (identified on prior slide)
Document Control (DC)
Quality Systems Assessment – 3 sections
Proficiency testing – all apply (QSA – QSA )
Systems standards – all apply (QSA – QSA )
Specialty & subspecialty – specific groups apply, listed alphabetically (QSA – QSA )
Example: Chemistry QSA – QSA
Waived testing: APRs, NPSGs, LD , WT chapters apply
Survey includes tissue, clinical transfusion practices and perioperative transfusion services

29. If organization & NONE of the non-waived laboratory services are Joint Commission Accredited:
Laboratory should follow:
Their non-waived laboratory accreditor’s requirements, e.g. CAP or COLA (surveyed every two years)
The Joint Commission organizational standards (surveyed every three years)
Waived testing requirements
Follow the most stringent requirements when standards vary between accreditors
Other clinical and hospital requirements related to lab service

30. If organization & SOME of the non-waived laboratory services are Joint Commission Accredited:
Most common scenario
Laboratory should follow:
The Joint Commission laboratory standards for services in which the organization applied, waived testing, tissue, clinical side of transfusion services, and perioperative transfusion services (surveyed every two years)
The other laboratory accreditor’s requirements (CAP or COLA) for the services in which they applied for accreditation (surveyed every two years)
The Joint Commission organizational standards (surveyed every three years)
Waived testing requirements
Follow the most stringent requirements when standards vary between accreditors
Other clinical and hospital requirements related to lab service

31. If organization & ALL of the non-waived laboratory services are Joint Commission Accredited:
Simplest scenario
The Joint Commission Laboratory standards (surveyed every two years)
The Joint Commission organizational standards (surveyed every three years)
Sites currently evaluating the opportunity for concurrent organization and laboratory survey every six years (every other organizational survey)

32. When should we participate in the Periodic Performance Review?
PPR Software
Web enabled tool via secure extranet
Self-assessment—non-punitive process
Submitted annually
Plans of Action / Measures of Success
Conference Call (Optional)
Standards Interpretation Staff (SIG)
Approval of POA and MOS

33. Completing the PPR
Always participate in the hospital’s PPR and the WT standards!
And if the laboratory services are surveyed…
Only by a Cooperative Partner
Support the hospital’s PPR with completing related standards
Participate in the partner’s self assessment process
By a combination of laboratory accreditors
Complete PPR review against the applicable standards in lab manual and support the related hospital standards
Only by The Joint Commission

34. The E-dition and Organization Customized Standards (OCS)

35. E-dition Standards Available Online

36. Customize your own service profile

37. View only applicable standards

38. View only applicable Elements of Performance

39. Organization Customized Standards (OCS)
Linked to specialties and services selected in application
Selections in application populate Survey Technology
Surveyors apply only those standards
Future – link application to E-dition?
Standards Applicability Grid in manual for reference
Advantages: Single set of standards, customizable based on specialty and service

40. 2010 Standards “Changes” No changes to the actual requirements
Standards Improvement Initiative
Improved clarity
Eliminated duplication
Reformatted/renumbered
NPSGs simplified
New chapter headings
Document Control (DC)
Emergency Management (EM)
Transplant Safety (TS)

41. National Patient Safety Goals
Retained
Two Patient Identifiers
Hand Hygiene
Revised (based on field input)
Critical Reporting
2010 goal is refocused on critical results
Critical tests no longer surveyed as part of the goal

42. National Patient Safety Goals
Moved to standards
Verbal results read-back
Do Not Use abbreviations
Hand-off communications
Removed
Modified Universal Protocol for bedside procedures (duplicates organization standard)
Treat Healthcare Acquired Infection (HAI) as sentinel event (duplicates Sentinel Event policy)
Patient involvement in care (duplicates organization standard)

43. Comparison of waived and non-waived testing requirements

44. Equivalent QC / Alternative QC
Traditional QC uses external liquid controls
Equivalent QC (EQC) may use electronic or internal monitors, e.g. simulators, on-board or automated QC
Also known as Alternative QC (AQC), to differentiate from Electronic QC
If the system simulates two levels of controls, it can be used to meet Joint Commission daily QC requirements for both waived and non-waived testing
Electronic “checks” are not sufficient

45. Equivalent QC (EQC) Requirements
Joint Commission Requirement
Non-waived
QSA
Waived* WT
Internal EQC minimums
ABGs: 2 levels daily with one q8 hours
All others: 2 levels once daily
At least once daily
Initial evaluation of internal monitoring system to determine Option
Option 1
Monitors entire analytical process
Option 2
Monitors portion of analytical process
Not required
Initial parallel validation of EQC vs. external QC
10 consecutive testing days
30 consecutive testing days
Ongoing external QC - Frequency
Once per calendar month & per lot and shipment
Once per calendar week & per lot and shipment
Per manufacturer instruction
or lab policy
Ongoing external QC - Levels
ABGs: 3 levels (per QSA )
All others: 2 levels
*Use of Option 1 or 2 requirements exceeds the standards.

46. Competency Requirements
Joint Commission Requirement
Non-waived
HR & HR
Waived WT
Content
Use all six methods
Blind testing
Direct observation of routine testing
Monitoring QC performance (by each user)
Written testing
Direct observation of instrument checks
Monitoring result reporting
Use 2 of 4 methods
Initial training and annual assessment
Yes
Semiannual in 1st year
Signatures
Director/supervisor must sign that the individual has received training and is competent prior to performing testing independently
Both the director/supervisor and the employee must sign that the individual has received training and is competent prior to performing testing independently 46

47. Comparison of Requirements
Joint Commission Requirement
Non-waived
Waived
CLIA certificate
Yes
Certificate of Accreditation (COA)
Certificate of Waiver (COW)
Establish P&P
Initial training and annual competency
Semiannual in 1st year
2 levels of QC each day
3 for ABGs
Reference intervals on patient chart
Quantitative results
Critical result reporting

48. Comparison of Requirements
Joint Commission Requirement
Non-waived
Waived
Method validation
Yes No
Equivalent QC (EQC) validation
Semiannual correlation studies
Semiannual calibration verification
Proficiency testing
(Or other verification procedure for nonregulated analytes)
Regulated: 3x per year
Nonregulated: Semiannual

49. Personnel Qualifications
Continues to be an area of focus
Recent years - emphasis on leadership roles
Laboratory Director (LD)
Clinical Consultants (CC)
Technical Supervisor (TS) and Technical Consultants (TC)
General Supervisor (GS)
Future - Anticipate added rigor for all roles
TIP: Laboratories must have records to demonstrate testing personnel meet the qualifications specified in CLIA at Subpart M.

50. Personnel Qualifications
Qualification routes specify required education and experience
High complexity testing requires Associate’s degree or higher [42CFR (b)(1-7)]
Moderate complexity testing requires high school diploma or higher [42CFR (b)(1-4)]
Credentials requiring advanced degrees are not sufficient to demonstrate education, e.g. MT(ASCP), CLS (NCA) or R.N. license

51. Resources on the Web Centers for Medicare and Medicaid Services (CMS)
CLIA:
CoPs:
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration CLIA Database Search
The Joint Commission’s
Frequently Asked Questions (FAQs)

52. To Subscribe:
Lab Focus:
Lab Stat News

53. Contact Us General information: Information on becoming accredited
Your account executive (see your organization’s secure Extranet site for specifics)
Information on becoming accredited
Contact Jennifer Rhamy
Phone:
Standards questions
Contact Megan Sawchuk or Cherie Ulaskas
Phone: , Option 6
Online:

54. QUESTIONS????

55. Thank you for participating!