The Joint Commission Laboratory
Program- What’s New
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Jennifer Rhamy
Executive Director
Me- and excited to be working with all of you
Lab STAT News monthly emails
Recent customer survey to hear voice of the
customer
Dedicated account executives for laboratory
Increased alliance of the hospital and lab
programs
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What’s New at The Joint
Commission
Ongoing
– Discounted program for bundled
proficiency testing, ASCP educational
programs, and The Joint Commission
accreditation.
– See www.labadvantage.org for more
information
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Lab Focus quarterly newsletter
Lab Advantage program
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
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Coming Soon
EXAMPLE: Crosswalk Display for Home
Health
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Joint Commission EP
CMS Requirements—may
include multiple CMS areas
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EXAMPLE: Crosswalk: Ambulatory
Care
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
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Come meet with us!
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
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Summary
Tips For A Successful Survey
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Kathie Steffens
Field Director
Documents and Information
Test Menu and Instruments Used
– Tests that you perform in your laboratory
Total Test Volume for each CLIA
CLIA Certificate(s)
– For all laboratory services provided on-site.
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– ABG =1 procedure
– pH, pCO2, pO2 = 3 tests
Documents and Information
Environmental and Safety Inspections
– Safety Committee Reports
– Hazardous Waste Disposal Manifests
– Infection Control Policy and Processes
– Data gathered
– Data analysis and conclusions
– Improvements Implemented
– On-going monitoring
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Performance Improvement
Documents and Information
– 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.
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Proficiency Testing for last 6 events
Documents and Information
Policy and Procedures
– Do not need to move to a central location
Quality Control Data
– Last 24 months accessible
– Performance over last 24 months
accessible
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Calibration and Calibration Verification
Documents and Information
Maintenance Records
– Last 24 months accessible
– Have someone available who knows HR
file system.
– Validation of educational requirements
– State licenses as applicable
Competency Assessment Records
– Current and last annual assessment
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 Personnel Files
Tracer Activity
– 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.
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Patient tracers cover all specialties and
subspecialties across the period from
the last full survey
Tips for Survey
– 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
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Know how to access information.
Tips for Survey
– 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.
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Encourage staff to openly participate.
Tips for Survey
Point-of-Care Sites
– Inform all staff that they will be asked to
participate in survey.
Off-site locations
Staff availability
– Let the surveyor know who might be
available only on certain days.
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– Inform all staff of same information that
will be required for their survey activity.
2010 Standards - Tips & Topics
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Megan E. Sawchuk, MT(ASCP)
Associate Director, Standards Interpretation Group
 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
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Standards Applicability
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
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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)
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Core standards chapters
Organizational standards applicable
to laboratory services

Waived testing: APRs, NPSGs, LD.04.01.01, 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
–
Many related to Medicare’s Conditions of Participation
(CoPs), e.g. 42 CFR 482.27 Hospital Laboratory
Services
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Other related clinical and hospital requirements,
e.g. transfusion medicine
Tip: Hospital standards related to
 EC.02.05.03 Emergency power for blood storage systems
 HR.01.02.01 Special training provided for transfusion administration
 MS.05.01.01 Medical staff involved in PI activities for blood & blood
use
 PC.02.01.01 Transfusions administered per law & medical staff policy
 PC.05.01.09 HIV/HCV Notification (Look back) policies
 PC.03.01.01 Transfusion administration equipment is available for
operative and other high-risk procedures
 PI.01.01.01 Organization collects data on blood and blood use, and
all reported and confirmed transfusion reactions
 RI.01.03.01 Informed consent process
 NPSG.01.01.01 Two identifiers used to ID patient for transfusion
 NPSG.01.03.01 Two persons verify patient ID and product for
transfusion
 UP.01.01.01 Standardized pre-op verification list, including blood
product availability (and other laboratory reports)
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blood administration
 HR.01.02.01 Testing personnel meet the qualifications defined in the
CLIA regulations
 IC.01.02.01 Laboratory resources are provided to support infection
prevention and control program
 IC.02.02.01 Cleaning and disinfection of bedside point-of-care
instruments, e.g. glucose meters
 LD.04.01.01 All laboratory services have CLIA certificates and
licenses required by regulation
 LD.04.03.01 Pathology and clinical laboratory services are provided
(essential service) to meet patient needs
 LD.04.03.09 Performance management of contracted laboratory
services; maintaining evidence of CLIA compliance for reference and
contract laboratory services
 MM.01.01.01 Necessary laboratory results are available to those
managing a patient’s medications
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Tip: Hospital standards related to
laboratory services
 MS.05.01.01 Medical staff involved in PI activities for autopsies
 MS.06.01.01 – MS.06.01.13 Credentialing and privileging of licensed
independent practitioners (LIPs) providing interpretive reports, e.g.
pathologists performing histopathology
 MS.08.01.01 – MS.08.01.03 Ongoing & Focused Practitioner
Performance Evaluation (OPPE & FPPE), applies to the above LIPs
 NPSG.02.03.01 Reporting of critical results (clinical reporting intervals,
such as nurse to physician, not those of the main laboratory)
 NPSG.03.05.01 Baseline and ongoing testing for anticoagulation
therapy provided per written protocol/policy approved by medical staff
 PC.03.01.08 Surgical tissue specimen policies, e.g. gross only,
exceptions to submission to pathology, specimen handling
 TS.03.01.01 – TS.03.03.01 Tissue storage and issuance (if lab oversees)
 WT.01.01.01 – WT.05.01.01 Waived Testing
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Tip: Hospital standards related to
laboratory services
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)
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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
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–
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Survey every three years for hospitals
Team of RN, MD, LSC, Administrator
No technical elements of testing are reviewed
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
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)
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Quality Systems Assessment – 3 sections
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Proficiency testing – all apply (QSA.01.01.01 – QSA.01.05.01)
–
Systems standards – all apply (QSA.02.01.01 – QSA.02.14.01)
–
Specialty & subspecialty – specific groups apply,
listed alphabetically (QSA.03.01.01 – QSA.21.01.01)
•
–

Example: Chemistry QSA.06.01.01 – QSA.06.02.01
Waived testing: APRs, NPSGs, LD.04.01.01, WT
chapters apply
Survey includes tissue, clinical transfusion
practices and perioperative transfusion services
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–
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
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–
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
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–
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)
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–
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
– Standards Interpretation Staff (SIG)
– Approval of POA and MOS
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Conference Call (Optional)
Completing the PPR
– 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
– Participate in the partner’s self assessment process
– Only by The Joint Commission
– Complete PPR review against the applicable standards in lab
manual and support the related hospital standards
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 Always participate in the hospital’s PPR and the WT
standards!
 And if the laboratory services are surveyed…
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The E-dition and Organization
Customized Standards (OCS)
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E-dition
Standards Available Online
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Customize your own service profile
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View only applicable standards
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View only applicable
Elements of Performance
Organization Customized
Standards (OCS)
Linked to specialties and services selected in
application
Selections in application populate Survey
Technology
Future – link application to E-dition?
Standards Applicability Grid in manual for
reference
Advantages: Single set of standards,
customizable based on specialty and service
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– Surveyors apply only those standards
2010 Standards “Changes”
No changes to the actual requirements
Standards Improvement Initiative
NPSGs simplified
New chapter headings
– Document Control (DC)
– Emergency Management (EM)
– Transplant Safety (TS)
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– Improved clarity
– Eliminated duplication
– Reformatted/renumbered
National Patient Safety Goals
Retained
– Two Patient Identifiers
– Hand Hygiene
– Critical Reporting
– 2010 goal is refocused on critical results
– Critical tests no longer surveyed as part of
the goal
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Revised (based on field input)
National Patient Safety Goals
Moved to standards
– Verbal results read-back
– Do Not Use abbreviations
– Hand-off communications
– 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)
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Removed
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Comparison of waived and nonwaived testing requirements
 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
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Equivalent QC / Alternative QC
Joint Commission
Requirement
Non-waived
Waived*
QSA.02.04.01
WT.04.01.01
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
Not required
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 Frequency
Ongoing external QC Levels
ABGs: 3 levels (per QSA.06.02.01)
All others: 2 levels
Per manufacturer instruction
or lab policy
*Use of Option 1 or 2 requirements exceeds the standards.
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Equivalent QC (EQC) Requirements
Joint Commission
Requirement
Content
Initial training and annual
assessment
Signatures
Non-waived
Waived
HR.01.04.01 & HR.01.06.01
WT.03.01.01
Use all six methods
1. Blind testing
2. Direct observation of routine
testing
3. Monitoring QC performance (by
each user)
4. Written testing
5. Direct observation of instrument
checks
6. Monitoring result reporting
Use 2 of 4 methods
1. Blind testing
2. Direct observation of routine
testing
3. Monitoring QC performance (by
each user)
4. Written testing
Yes
Yes
Semiannual in 1st year
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
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Competency Requirements
Comparison of Requirements
Non-waived
Waived
Yes
Yes
CLIA certificate
Certificate of Accreditation
(COA)
Certificate of Waiver
(COW)
Establish P&P
Yes
Yes
Initial training and annual
competency
Yes
2 levels of QC each day
Semiannual in 1st year
Yes
3 for ABGs
Reference intervals on
patient chart
Yes
Critical result reporting
Yes
Yes
Yes
Yes
Quantitative results
Yes
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Joint Commission
Requirement
Joint Commission
Requirement
Non-waived
Waived
Method validation
Yes
No
Equivalent QC (EQC)
validation
Yes
No
Semiannual correlation
studies
Yes
No
Semiannual calibration
verification
Yes
No
Proficiency testing
Yes
(Or other verification procedure for
nonregulated analytes)
Regulated: 3x per year
Nonregulated: Semiannual
No
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Comparison of Requirements
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.
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Qualification routes specify required
education and experience
High complexity testing requires Associate’s
degree or higher [42CFR 493.1489(b)(1-7)]
Moderate complexity testing requires high
school diploma or higher [42CFR 493.1423(b)(1-4)]
Credentials requiring advanced degrees are
not sufficient to demonstrate education, e.g.
MT(ASCP), CLS (NCA) or R.N. license
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Personnel Qualifications
Resources on the Web
Centers for Medicare and Medicaid Services (CMS)
CLIA: www.cms.hhs.gov/clia
CoPs: www.cms.hhs.gov/CFCsAndCoPs/
Centers for Disease Control and Prevention (CDC)
www.phppo.cdc.gov/clia
The Joint Commission’s
Frequently Asked Questions (FAQs)
http://www.jointcommission.org/Standards/FAQs
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Food and Drug Administration CLIA Database Search
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
To Subscribe:
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Lab Focus:
http://www.jointcommission.org/Library/
Newsletters/list_serve.htm
Lab Stat News
qualitylabs@jointcommission.org
Contact Us
 General information:
–
Your account executive (see your
organization’s secure Extranet site for specifics)
 Information on becoming accredited
Contact Jennifer Rhamy
Phone: 630-792-5754
Email: jrhamy@jointcommission.org
 Standards questions
–
–
–
Contact Megan Sawchuk or Cherie Ulaskas
Phone: 630-792-5900, Option 6
Online: http://www.jointcommission.org/Standards/OnlineQuestionForm/
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QUESTIONS????
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Thank you for participating!