Most Challenging Lab
Standards 2012
April 26, 2012
Stacy Olea, MBA, MT(ASCP), FACHE
Field Director
Accreditation and Certification Operations
April 26, 2012 Lab Teleconference- 1
The Joint Commission’s Vision
All people experience the safest, highest quality,
best-value health care across all settings.
The Joint Commission’s Mission
To continuously improve health care for the
public, in collaboration with other stakeholders, by
evaluating health care organizations and
inspiring them to excel in providing safe and
effective care of the highest quality and value.
April 26, 2012 Lab Teleconference- 2
Objectives
Review challenging standards and strategies for
compliance
– Personnel Qualifications
– Competency
– Calibration Verification
– Transplant Safety
– Transfusion
Tools available from The Joint Commission to assist
organizations in attaining compliance
April 26, 2012 Lab Teleconference- 3
Personnel Qualifications
HR.01.02.03 EP 1 The qualifications of the
laboratory director of record meet the requirements
set forth in federal and state law and regulation.
HR 01.01.01 EP 1 An individual qualified to provide
technical consultation or supervision and general
supervision is on duty or is available whenever
testing requires consultation or supervision.
HR.01.02.05 EP 3 The laboratory verifies and
documents that the applicant has the education and
experience required by the job responsibilities.
April 26, 2012 Lab Teleconference- 4
Laboratory Director of Record
Varies depending on complexity
Non Pathologist Physicians
– Moderate Complexity (requires only 1)
– Equivalent laboratory training during residency
– 20 CME credit hours in laboratory practice
commensurate with director responsibilities
– One year directing or supervising nonwaived testing
– High Complexity (requires only 1)
– One year of laboratory training during residency
– Two years of experience directing or supervising high
complexity testing
April 26, 2012 Lab Teleconference- 5
Technical Consultant
Non Pathologist Physician
– One year lab training or experience in the
designated specialty/subspecialty of responsibility
Doctorate, Masters, Bachelors Degrees
– Chemical, physical, biological science, or clinical
laboratory science/medical technology AND
– One year lab training or experience in the
designated specialty/subspecialty of responsibility
April 26, 2012 Lab Teleconference- 6
Technical Supervisor
Non Pathologist Physician
– Certified in clinical pathology by ABP, AOBP, or
equivalent OR
– One year training or experience in high
complexity testing in the respective specialty
Doctorate
– Chemical, physical, biological science or clinical
laboratory science AND
– One year training or experience in high
complexity testing in the respective specialty
April 26, 2012 Lab Teleconference- 7
Technical Supervisor
Masters
– Chemical, physical, biological science or clinical
laboratory science/medical technology AND
– Two years training or experience in high
complexity testing in the respective specialty
Bachelors
– Chemical, physical, biological science or clinical
laboratory science/medical technology AND
– Four years training or experience in high
complexity testing in the respective specialty
April 26, 2012 Lab Teleconference- 8
General Supervisor
Qualify as a laboratory director of high complexity testing
Qualify as a technical supervisor of high complexity testing
Non Pathology Physician
– One year training or experience in high complexity testing
Doctorate, Masters, Bachelors Degrees
– Chemical, physical, biological science, or clinical laboratory
science/medical technology AND
– One year training or experience in high complexity testing
Associate Degree
– Laboratory Science or Medical Laboratory Technology
AND
– Two years training or experience in high complexity testing
April 26, 2012 Lab Teleconference- 9
Testing Personnel Moderate
Complexity
MD, DO, DPM with current medical license in the
state of lab’s location
Doctorate, Masters, Bachelors, Associate degree
– Chemical, physical, biological science or clinical
laboratory science/medical technology
High School Graduate or equivalent
– Successfully complete military training of 50 or
more weeks and served as a medical laboratory
specialist
April 26, 2012 Lab Teleconference- 10
Testing Personnel Moderate
Complexity
High School Diploma or equivalent with experience or
appropriate training documented prior to analyzing patient
specimens:
Skills required for proper specimen collection, patient
preparation, labeling, handling, preservation/fixation,
processing/preparation, transportation, and storage of
specimens
Skills required for implementing all standard laboratory
procedures
Skills for performing each test method and for proper
instrument use
Skills for performing preventative maintenance,
troubleshooting and calibration procedures
April 26, 2012 Lab Teleconference- 11
Testing Personnel Moderate
Complexity
High School Diploma or equivalent with experience or
appropriate training documented prior to analyzing patient
specimens:
Working knowledge of reagent stability and storage
Skills required to implement quality control policies and
procedures
Skills required to assess and verify the validity of patient
test results through the evaluation of quality control
sample values prior to reporting patient test samples
An awareness of the factors that influence test results
April 26, 2012 Lab Teleconference- 12
Testing Personnel High
Complexity
MD, DO, DPM with current medical license in state of lab’s
location
Doctorate, Masters, Bachelors degree
– Chemical, physical, biological science or clinical laboratory
science/medical technology
Associate degree
– Laboratory science or medical laboratory technology
Education AND training equivalent to an associate degree in
laboratory science or medical laboratory technology
April 26, 2012 Lab Teleconference- 13
Qualifications
Opportunities
– Understand the CLIA requirement for all required personnel
https://www.cms.gov/CLIA/downloads/apcsubm.pdf
– Have a policy to verify highest level of education and follow
the policy
– Make sure to include staff performing POCT and
phlebotomists if they perform nonwaived testing
– State licensure for physicians, midlevel practitioners,
MTs/MLSs, and MLTs requires no further academic
documentation
– RN, RT, MT(ASCP) are not specified as qualification routes
in the federal CLIA regulations
– Lab Central
April 26, 2012 Lab Teleconference- 14
Competency Requirements
Joint
Commission
Requirement
Nonwaived Testing
including PPMP
Waived Testing
Methods
Use 6 methods (if applicable)
1. Blind testing
2. Direct observation of routine
testing
3. Monitoring of QC performance
by each user
4. Problem solving skills
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 of QC
performance by each
user
4. Written test
Initial Training and
Annual Assessment
Yes
Semi-annual in the first year
Yes
Signatures
Both the director/supervisor AND
the employee must sign that the
individual has received training and
is competent prior to performing
testing independently
No signature required but
the director/designee
assesses competency
April 26, 2012 Lab Teleconference- 15
Competency – Waived Testing
WT.03.01.01 EP 5 Competency for waived testing is
assessed using at least two of the following methods
per person per test: performance of a test on a blind
specimen, periodic observation of routine work by
the supervisor or qualified designee, monitoring of
each user’s quality control performance, use of a
written test specific to the test assessed.
WT.03.01.01 EP 6 Competence for waived testing is
assessed according to organization policy at defined
intervals, but at least at the time of orientation and
annually thereafter. This competency is
documented.
April 26, 2012 Lab Teleconference- 16
Competency – Waived Testing
Opportunities
– Use routine quality surveillance activities to meet some of
the assessment methods
– Use credentialing and privileging process for noninstrumented waived tests
– Use annual skill fairs (blind sample & written test)
– Make this automated and electronic
– Create an assessment grid to track completion
– Leading Practice Library
– Lab Central
April 26, 2012 Lab Teleconference- 17
Competency – Nonwaived and
PPMP Testing
HR 01.06.01 EP 18 The staff member’s competency
assessment includes the following: Direct observation of
routine patient test performance, including patient preparation,
if applicable, and specimen collection, handling, processing,
and testing; Monitoring, recording, and reporting of test results;
Review of intermediate test results or worksheets, quality
control, proficiency testing, and preventative maintenance
performance; Direct observation of performance of instrument
maintenance function checks and calibration; Test performance
as defined by laboratory policy (for example, testing previously
analyzed specimens, internal blind testing samples, external
proficiency, or testing samples);Problem solving skills as
appropriate to the job
April 26, 2012 Lab Teleconference- 18
Competency – Nonwaived and
PPMP Testing
HR.01.06.01 EP 20 After the first year of
employment, each staff member’s competence is
assessed on an annual basis for all laboratory tests
he or she performs. This assessment is
documented.
April 26, 2012 Lab Teleconference- 19
Competency – Nonwaived and
PPMP Testing
Too big to be the responsibility of one person
Create an assessment grid for each employee
– Across the top list the 6 assessment methods
required by CLIA
– Down the Left side
– Analyzer Name & Method (do not list every
analyte)
– Non-instrument tests
– Non-testing protocols (venipuncture, specimen
handling)
April 26, 2012 Lab Teleconference- 20
Competency – Nonwaived and
PPMP Testing
Direct Observation Testing Performance
– Do this the same time you do hand hygiene observations
– Make time in your schedule
– Employees should keep their assessment grid accessible
Monitoring/Recording/Reporting
– Included in surveillance program (critical results, delta
checks, abnormal, transcription errors, corrected reports,
incident reports)
Review of worksheets/QC/PT/PM
– Included in surveillance program (QC charts, PT reports,
Instrument PM records)
April 26, 2012 Lab Teleconference- 21
Competency – Nonwaived and
PPMP Testing
Direct Observation Instrument Maintenance Function Checks,
Calibrations
Test Performance
– Create a spreadsheet for employees to track their PT performance
– Create a blind sample for employees to test. Include criteria to
determine if results are acceptable
Problem Solving Skills
– Have employee give a presentation to staff regarding
troubleshooting an assigned analyzer or test
– Have employees submit examples/documentation of
troubleshooting skills
– Copy a problem-solving item from a communication log or QC
chart
– Use a written exam with a defined acceptable score
April 26, 2012 Lab Teleconference- 22
Competency –Nonwaived and
PPMP
Opportunities
– Involve the staff in collecting and maintaining documents
– Use routine quality surveillance activities to meet some of
the assessment methods
– For PPMP credentialing and privileging does not count as
the competency assessment
– Make this automated and electronic
– Verify that first year hires have a 6 month assessment
– Use the methods that are applicable
– Evaluate by platform and group “like” tests together
– Leading Practice Library
– Lab Central
April 26, 2012 Lab Teleconference- 23
Calibration Verification
A Brief Overview
John Gibson MA, MT(ASCP),
DLM
Associate Director
Standards Interpretation Group
The Joint Commission
April 26, 2012 Lab Teleconference- 24
Objectives
At the conclusion of this presentation the
participant will be able to:
1. Define calibration and calibration
verification.
2. Determine when calibration verification
is required.
3. Identify materials used for calibration
verification.
April 26, 2012 Lab Teleconference- 25
Calibration
Federal Definition
42 CFR 493.2
“Calibration means a process of testing and
adjusting an instrument or test system to
establish a correlation between the
measurement response and the
concentration or amount of the substance
that is being measured by the system.”
April 26, 2012 Lab Teleconference- 26
QSA.02.02.01
Outlines Calibration Requirements
Procedure Addresses
1. Manufacturer’s requirements.
2. Number of calibration levels.
3. Type of calibration materials used (NIST
traceable if possible)
4. Concentration of Calibration Materials
(Establishes reportable range)
5. Frequency of calibration.
6. Performance limits of calibration.
April 26, 2012 Lab Teleconference- 27
Recalibration Requirements
Recalibrate when
1. Calibration fails.
2. Calibration verification fails.
3. Indicated by QC. (Shifts, Trends)
4. Indicated by performance function
checks.
April 26, 2012 Lab Teleconference- 28
Calibration Verification
Federal Definition
42 CFR 493.2
“Calibration verification means the assaying
of materials of known concentration in the
same manner as patient samples to
substantiate the instrument or test
system’s calibration throughout the
reportable range for patient test
results.”
April 26, 2012 Lab Teleconference- 29
QSA.02.03.01
Outlines Calibration Verification
Requirements
Procedure Addresses
1. Manufacturer’s requirements.
2. Number of calibration verification levels.
3. Type of calibration verification materials.
4. Concentration of calibration verification
materials.
5. Frequency of calibration verification.
6. Acceptable performance limits.
April 26, 2012 Lab Teleconference- 30
Frequency
Methods with 3 or more calibrators which
are calibrated at least every six months
are
EXEMPT
from semi-annual requirement
April 26, 2012 Lab Teleconference- 31
Not Exempt from
1. Complete change of reagents unless
reportable range not impacted.
(Lot specific calibrator values requires
calibration verification)
(Crossover study of QC before and
after reagent change to look for shift in
mean)
2. Major maintenance on parts which
influence results (lamp changes,
detector cell changes, computer boards)
April 26, 2012 Lab Teleconference- 32
Other Exemptions
1. Manual procedures not involving an
instrument.(Cultures, Kirby Bauer,
manual cell counts).
2. Microscopic procedures (WBC
differentials cytology screening, KOH
preps).
3. Procedures involving an instrument in
which calibration is not practical
(prothrombin times).
April 26, 2012 Lab Teleconference- 33
Frequency
1. Every six months.
2. Complete change of reagents unless
reportable range not impacted.
(Lot specific calibrator values requires
calibration verification)
(Crossover study of QC before and after
reagent change to look for shift in mean)
3. Major maintenance on parts which influence
results (lamp changes, detector cell
changes, computer boards)
April 26, 2012 Lab Teleconference- 34
Frequency (cont)
4. QC indicators.
5. Environmental change – instrument
relocation.
6. Replacement of instrument
April 26, 2012 Lab Teleconference- 35
Contact Standards Interpretation
www.jointcommission.org
Standards Tab
Online Question Form
630-792-5900 Option 6
April 26, 2012 Lab Teleconference- 36
Transplant Safety
April 2012
John Gibson MA, MT(ASCP), DLM
Standards Interpretation Group
April 26, 2012 Lab Teleconference- 37
Tissue Standards
(AHC, CAH, HAP, LAB, OBS: TS.03.01.01)
The organization assigns responsibility for
overseeing the tissue program throughout
the organization.
The organization has procedures to
standardize systems and processes to
address the following:
– Acquiring
– Receiving
– Storing
– Issuing
April 26, 2012 Lab Teleconference- 38
Tissue Standards
(AHC, CAH, HAP, LAB, OBS: TS.03.01.01)
Ambient vs. Room Temperature storage
Ambient
– Temperature of the surrounding area
– Temperature records are not required
Room Temperature
– Specific temperature range
– Temperature records are required
Check manufacturer’s package insert for specific
language
April 26, 2012 Lab Teleconference- 39
FDA Registration
Tissue suppliers must be registered by the FDEA as
Tissue Establishments. Verify registration annually.
https://www.accessdata.fda.gov/scripts/cber/CFApps
Pub/tiss/index.cfm
April 26, 2012 Lab Teleconference- 40
Tissue Standards
(AHC, CAH, HAP, LAB, OBS: TS.03.02.01)
The organization’s record keeping
ensures traceability
This is a critical process in investigating
adverse events
The who, what, when, where (and
sometimes why…) of what happened to
the tissue
– Transplant Utilization Record (TUR) card
returned to source facility
April 26, 2012 Lab Teleconference- 41
Tissue Standards
(AHC, CAH, HAP, LAB, OBS: TS.03.03.01)
The organization has systems to investigate adverse events.
Critical because….
– Prompt investigation of each event provides response and
treatment to recipients affected by the infected tissue.
– Effective communication of an adverse event directly
related to tissue use is critical to patient safety and helps to
prevent spread of infection from infected donor.
Consistently in the Top 10 most frequently cited laboratory
standards
– Update! Has dropped to the 25th position in 2009!
April 26, 2012 Lab Teleconference- 42
Tissue Standards
(AHC, CAH, HAP, LAB, OBS: TS.03.03.01)
– What do you do when you find out from the source
facility that a tissue is suspected of carrying an
infectious disease?
– What is the process for identifying and informing
the recipient?
– What do you do when you find out from the patient
(via physician, nurse, ICP, etc.) that the tissue is a
possible cause of infection or other adverse event?
– How would you report these to the source facility
April 26, 2012 Lab Teleconference- 43
Tissue Standards
Frequently Asked Questions
What is The Joint Commission looking for in regards
to tissue suppliers?
– Evidence of the source facility’s FDA registration
– State license if applicable
Our organization does not “store” tissues (implanted
same day received); do these standards still apply?
– Yes, as applicable.
April 26, 2012 Lab Teleconference- 44
Challenging Transfusion
Standards
John Gibson MA, MT(ASCP), DLM
Associate Director
Standards Interpretation Group
April 26, 2012 Lab Teleconference- 45
LD.04.05.09 EP 2
New and revised procedures must be
signed and dated by the laboratory
director whose name is on the CLIA
Certificate.
Cannot be delegated to a subject
matter expert.
May co-sign with subject matter expert
April 26, 2012 Lab Teleconference- 46
QSA.05.01.01 EP 4
Annual reviews of unchanged
procedures must be documented by
the laboratory director whose name is
on the CLIA Certificate or by an
individual qualified as a technical
supervisor in immunohematology.
Technical supervisor qualifications can
be found at 42 CFR 493.1449.
April 26, 2012 Lab Teleconference- 47
QSA.05.01.01 EP 5
The transfusion service director has
oversight of policies, processes, and
procedures related to the blood
transfusion service, including blood
administration.
April 26, 2012 Lab Teleconference- 48
QSA.05.18.01 EP 3
Policies and procedures for nursing
services related to blood and blood
component administration do not
conflict with the laboratory’s policies
and procedures.
April 26, 2012 Lab Teleconference- 49
QSA.05.18.01 EP 2 Bullet 5
… suspected transfusion-related
adverse events are reported
immediately to the laboratory, whether
or not the physician responsible for the
patient deems it necessary to report the
event.
April 26, 2012 Lab Teleconference- 50
QSA.05.18.01 EP 7
The organization follows its policies
and procedures which guide the
monitoring of the patient and the
reporting of suspected transfusionrelated adverse events during blood
and blood component administration.
April 26, 2012 Lab Teleconference- 51
QSA.05.19.05 EP 2
The interpretation of the transfusion
reaction workup provided by the
transfusion service director is in the
patient’s clinical record.
April 26, 2012 Lab Teleconference- 52
QSA.15.10.01 EP2 Bullet 4
Policy and procedure includes a
protocol for labeling donor and recipient
blood, including securely affixing the
label to the units after crossmatching
and retention of the label on the units
until the transfusion is completed.
April 26, 2012 Lab Teleconference- 53
What is The Joint Commission
doing to help you with
challenging standards?
Stacy Olea, MBA, MT(ASCP),
FACHE
April 26, 2012 Lab Teleconference- 54
Standards Interpretation Group
Phone:
630-792-5900 Option 6
Online:
http://www.jointcommission.org/Standards/OnlineQuestionForm/
FAQs:
http://www.jointcommission.org/Standards/FAQs
April 26, 2012 Lab Teleconference- 55
Leading Practice Library
Opened to all of our accredited organizations
Database to formally identify and share leading
practices (including case studies, white papers,
tools, policies, etc.) which reflect excellent
compliance with Joint Commission standards and
National Patient Safety Goals.
Sort by program
April 26, 2012 Lab Teleconference- 56
Center for Transforming
Healthcare
Formed in 2009 to find solutions to pressing health care issues
identified by CEOs
Uses DMAIC principles to analyze and identify root causes
which vary by institution
– One size does not fit all for persistent issues!
Projects include:
– Hand hygiene
– Hand off communications
– Wrong Site surgery
– Surgical Site infections (with ACS)
– Safety Culture
Solutions database available from Joint Commission to enter
your own data and perform your own project to improve care
April 26, 2012 Lab Teleconference- 57
Lab Central
New customer portal that improves
accreditation:
– Allows organizations to organize files in one place
to make surveys more efficient
– Surveyors can review data before the survey to
get better snapshot of organization
– Data available for ICM discussion with SIG
– Provides a place for private document
management
Current projection is summer implementation
for initial voluntary use
April 26, 2012 Lab Teleconference- 58
April 26, 2012 Lab Teleconference- 59
April 26, 2012 Lab Teleconference- 60
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
–
Phone: 630-792-5900, Option 6
–
Online:
http://www.jointcommission.org/Standards/OnlineQuestionForm/
April 26, 2012 Lab Teleconference- 61
Resources on the Web
Centers for Medicare & 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
Food and Drug Administration CLIA Database Search
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm
CLSI-Joint Commission Crosswalk
http://www.clsi.org/Content/NavigationMenu/Resources/TJC_
CrosswalkWEB.pdf
April 26, 2012 Lab Teleconference- 62
Questions
April 26, 2012 Lab Teleconference- 63