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©MFMER | 3793435-1
Advanced Proficiency Testing:Applications in Laboratory Networks
Deborah J. WellsQuality ManagerDepartment of Laboratory Medicine & PathologyMayo Clinic, Rochester, MN
©2018 MFMER | 3793435-2
Disclosures
Relevant Financial Relationship(s):Nothing to Disclose
Off Label Usage:Nothing to Disclose
NOTE: Any mention or suggestion of instruments, brands or supplies does not represent an endorsement.
This session is intended for informational use only.
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Objectives• Define three (3) critical differences between complying with Proficiency Testing (PT) regulations in
a single lab versus within a health system or laboratory network.
• Describe the role of the Laboratory Information System in PT compliance.
• Develop system level PT policies and practices which facilitate improved PT compliance.
• Apply principles of improved compliance to your laboratories.
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A. In a stand-alone hospital or clinicB. In a small network, less than 10 labsC. In a large network, greater then 10 labs
Where do you work?
In a sta
nd-alon
e hos
pital
or cli
nic
In a sm
all ne
twork,
less
than
10 la
bs
In a lar
ge ne
twork,
grea
ter th
en 10
labs
0% 0%0%
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A. I have no ideaB. Only one – one labC. One – includes multiple D. Many, typically one for each lab
How many different CLIA certificates/numbers are in Your Laboratory Network?
I hav
e no id
ea
Only one
– one l
ab
One – in
clude
s mult
iple
Many,
typica
lly one f
or ea..
0% 0%0%0%
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A. Yes (perform testing)B. NoC. We refer tests to one site only for processing
prior to sending to a Reference Lab
Do your Network Labs refer tests to each other?
Yes (p
erform
testi
ng) No
We refe
r tests
to on
e site
...
0% 0%0%
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A Very Brief Review…CLIA Proficiency Testing (PT)• Test PT samples the same as patients, except reflex testing sent to another laboratory.
• Rotate PT sample testing among testing personnel.
• Do not refer PT samples outside of your laboratory.
• Do not discuss PT results with another laboratory prior to the PT event deadline.
• If you receive PT samples from another laboratory, notify your inspecting agency and do not test the samples.
• Procedures and training must include PT testing.
Source: CLIA Proficiency Testing and PT Referral Dos and Don’ts. September, 2017. (Previously CLIA Brochure 8).
www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html
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So what happens at a System Level?
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So what happens at a System Level?
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What makes PT different in a Lab Network?1. Multiple laboratories
2. Multiple CLIA numbers
3. The same analyte may be performed at multiple sites
4. Increased complexity
5. Potential for increased risk
6. Network oversight
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Lab 1Hospital
CLIA 1111
Lab 2Clinic
CLIA 2222
Lab 3OB/GYN
Office
CLIA 3333
Lab 4Oncology
CLIA 4444
Lab 5Reference
Lab
CLIA 5555
What is your network CLIA structure?
Acme Laboratories System Network
Multiple labs under different CLIA certificates
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How are tests referred?
Clinic Hospital ReferenceLab
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What can be done to prevent PT referral?
• A separate test order code used only for PT testing?
• LIS prevents reflex testing for these PT test order codes?
• Separate confidential patient type for PT testing?
• Clear policies and procedures!
• Training and more training!
For additional information: www.cap.org “Proficiency Testing Interlaboratory Communication – Strategies for Prevention.” 2017.
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Differences in commonly referred technical specialties
Centralized Microbiology:
• Increased reflex testing (i.e. positive screens may be forwarded to the central lab for confirmation testing)
• Greater risk of referral, therefore greater scrutiny is required
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Differences in commonly consolidated technical specialties
Anatomic Pathology (Histology):
• On January 10, 2020 CMS issued a memo regarding Histology slide preparation.
• Slide preparation and staining is not considered “testing” – only the interpretation is “testing.”
• Therefore, labs which send PT specimens to a central Histology for slide preparation have not referred PT.
• Earlier CMS communications also applied this to immunohistochemistry (IHC) staining.
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One approach to reducing risk might be to use different PT vendors
…and other CLIA/CAP approved PT vendors
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Clinic Hospital ReferenceLab
How are tests referred?
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Preventing PT Referral Receipt• Labs which receive specimens from their other network labs with different CLIA numbers must be
vigilant
• Labs which receive specimens from outreach clients must be vigilant
• Typically, orders are received before specimens
• How can orders be screened?
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Preventing PT Referral ReceiptScan orders for “key words”
Scans for: Reason:CAP PT vendor
PT Commonly used
Survey Commonly used
API PT vendor
VM Analytes likely to have reflex testing
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Preventing PT Referral Receipt• Review the situation at the network level first
• Anticipate testing with reflex orders
• Clear, strong policies/procedures prohibiting it at each site
• Mandatory staff training
For more info: www.cap.org “Proficiency Testing Compliance FAQ’s”. Reviewed 12.20.2018.
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What is your network CLIA structure?
Lab 1Hospital
CLIA 1111
Lab 2Clinic
CLIA 2222
Lab 3OB/GYN
Office
CLIA 3333
Lab 4Oncology
CLIA 4444
Lab 5Dr. Acme’s
Office
CLIA 5555
Acme Laboratories System Network
Multiple labs under different CLIA certificates
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A. Sent with courier to Quality Officer, who enters them online.
B. The results are faxed to the Network Quality Manager, who enters them online.
C. Entered on line by the staff/supervisor who tested the PT specimens at that site.
D. Either “A” or “B”
In your network, how are PT results for multiple labs submitted?
Sent w
ith co
urier to
Qual.
..
The res
ults ar
e fax
ed to
...
Entered
on line b
y the s
ta..
Either
“A” o
r “B”
0% 0%0%0%
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If PT is performed at “Lab 2”:Who performs it?
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If PT is performed at “Lab 2”:And better yet… who reports it?
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How are PT results for multiple labs submitted?Lab 2ClinicCLIA 2222
Lab 1HospitalCLIA 1111
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How are PT results for multiple labs submitted?Lab 2ClinicCLIA 2222
Lab 1HospitalCLIA 1111
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How are PT results for multiple labs submitted?Lab 2ClinicCLIA 2222
Lab 1HospitalCLIA 1111
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If PT is performed at “Lab 2”:And better yet… who reports it?
Answer: the staff who performed it, at their location! lab location!
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CAP COM.01800 Phase II• Must be entered at performing site.
• Best if its performing staff who enters.
• Ensure network-level and local procedures stipulate this…
• Ensure PT training records are kept for all staff.
For review:
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A tremendous advantage: Cross-trained Floating Staff
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A tremendous advantage: Cross-trained Floating Staff
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Cross-trained Floating Staff
CAP Survey C-Bdue 4/9/2019
CLIA # 1111 CLIA # 2222
CAP Survey C-Bdue 4/9/2019
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Cross-trained Floating Staff
• Carefully develop policies/procedures specific to your network.• Train all staff at all sites.• Tom the Tech must not perform the same PT testing at both sites.• Tom the Tech must not discuss the PT testing at any other sites except at the one which
performed it.
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Does your Lab Network use a NetworkLab Information System (LIS)?
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A. Is planned to be network in the next year or soB. Shares a common databaseC. Has individual databases with separationD. Limits staff review of PT at other sitesE. B & D
My Network’s Laboratory Information System (LIS):
Is plan
ned to
be enter
pris...
Shares
a co
mmon databas
e
Has in
dividual
datab
ases
...
Limits
staff
revie
w of PT a.
..B & D
0% 0% 0%0%0%
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How are specimens from sites identified?
CLIA # 2222
CLIA # 3333
CLIA # 4444
CLIA # 5555
CLIA # 6666
CLIA # 1111
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Are PT sample labels differentiated by Site?
CAP C-1
2020 SerumRhubarbCAP C-1
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CAP’s Recommendations for Common LIS’s:
• Audit records to identify who has accessed PT results within the LIS.
• Create masked identifiers for each laboratory’s PT samples
Reference: www.cap.org “Proficiency Testing Interlaboratory Communication – Strategies for Prevention. 2017.
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CAP COM.01800 Interlaboratory Communication
• PT records must not be shared with and should be inaccessible to personnel of other laboratories, including an affiliated laboratory until after the deadline for submission of results.
• Laboratories that share a common computer system or personnel must have strict policies and procedures to ensure that personnel do not access proficiency testing records from other laboratories.
For additional information: www.cap.org “Proficiency Testing Interlaboratory Communication – Strategies for Prevention.” 2017.
For review
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A. Each Lab evaluates its ownB. The Network Quality Dept. ReviewsC. The Lab evaluates, then sends to the NetworkD. Metrics are captured for all Labs & reviewed by allE. All of the above
How does your network evaluate PT?
Each La
b evalu
ates i
ts ow
n
The Ente
rprise
Quali
ty Dep
..
The Lab
evalu
ates,
then ...
Metrics
are c
aptur
ed fo
r al...
All of th
e abo
ve
0% 0% 0%0%0%
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PT failuresBy reviewing network PT performance data in aggregate, much can be learned:
• Opportunity to improve overall performance.
• Implementation of best practices.
• Quality transparency creates greater team effort.
• Evaluation of technical performance vs. clinical practice.
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Refresher: “One PT Kit per CLIA”
• In August 2015, CAP was advised by CMS (per CLIA) that it must enforce “one kit per CLIA”
• Each analyte would therefore be limited to a single PT kit, when analytes are performed:• in multiple locations, • or on duplicate instruments, • or using different methods
• Only one testing location/platform/method per CLIA lab can perform Proficiency Testing.
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What impact does “One Kit per CLIA” have?
Acme Laboratories System NetworkCLIA # D1234567
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Implications for multiple laboratories under one CLIA number• Test and report PT in one (1) laboratory section:
• Identify Primary and Secondary testing locations/platforms- perform PT on primary tests.• Or rotated among primary tests with each PT shipment.
• When PT is not available, AAP must be performed.
• Comparability testing between primary and secondary labs is always required.
• Number of locations/platforms performing PT decreased, and the number of locations/platforms performing comparisons increased.
Proficiency Testing Comparisons
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For Rochester Downtown Campus alone: 307 tests evaluated
How to Organize?
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Comparability and Competency Assessment
For example:
A lab section sends three (3) blinded patient samples to another lab section. This is performed twice per year.
• This data could be used to satisfy Comparability requirements.• This data could also be used to satisfy Competency requirements.
…However both purposes must be clear.
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Comparability Comparisons and Competency
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In Summary• Laboratories working together in networks are a growing trend and have advantages.
• Proficiency testing at the network level requires some level of network oversight, as the challenges may be different than those of stand-alone laboratories.
• Careful planning and clear policies are critical to successful network proficiency testing!
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Special Thanks:Mayo Clinic Laboratories
Department of Laboratory Medicine and Pathology
Proficiency Testing Quality Team
Rochester, MN
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Questions?
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