State of Wisconsin
CLIA Team
Clinical Laboratory
Improvement
Amendments (CLIA)
Laboratory Provider
Forum
February 21, 2024
CLIA Overview with Focus on
Certificate of Waiver (CoW) and
Provider Performed Microscopy
(PPM) Certified Labs
Welcome
2
Angela K. Mack, MLS(ASCP)
Licensing, Certification, and CLIA Section Manager
Division of Quality Assurance | Bureau of Health Services
Charise Mancheski
License/Permit Program Associate
Division of Quality Assurance | Bureau of Health Services
Anita Iwanski, MBA, MLS(ASCP)
Laboratory Certification Officer
Division of Quality Assurance | Bureau of Health Services
Ann Hansen
Bureau of Health Services Director
Division of Quality Assurance | Bureau of Health Services
Objectives
3
Provide information so laboratories can:
• Understand the CLIA application process;
• Perform Waived testing—regulatory requirements and best
practices;
• Understand Provider Performed Microscopy (PPM) regulatory
requirements.
Disclaimer: The information presented in this CLIA Provider Forum is for educational purposes
only. Refer to Standards and Certification: Laboratory Requirements (42 CFR 493) for official
CLIA Regulations.
To Ask a Question
4
▪ Click the Q&A button
▪ Type your question in the Q&A box and Submit
▪ Please DO NOT submit questions using the Chat Button
▪The Centers for Medicare &
Medicaid Services
▪The Food and Drug
Administration
▪The Centers for Disease
Control and Prevention
5
CLIA Program Oversight and
Administration
CDC, Lab Training, Introduction to CLIA
Types of CLIA Certificates
6
CDC, Lab Training, Introduction to CLIA
CLIA Certificate Application and
Renewal Processes
Charise Mancheski, License/Permit Program Associate
7
Obtaining a CLIA Certificate
8
▪Who needs a CLIA Certificate?
• Traditional and Non-traditional Settings
▪Testing Not Subject to CLIA
• Forensic
• Research
• TB Skin Testing
• Breath Alcohol
• Blood Collection
• Continuous Blood Glucose Monitors
Each facility needs their own CLIA certificate.
▪ Signature--Wet or Traceable Electronic
▪ Print Legibly or Type in On-line
▪ Fully completed—If updating, can request pre-
populated 116 Form and just note changes.
▪ Example of Waived Test List Section—Covid,
Drug, Blood Glucose, ICUP Alere
▪ Refer to FDA CLIA Database—Test Complexity
Look-up website to determine the complexity
level of the testing done in your laboratory--
waived, moderate, or high complexity.
▪ Word of Caution: CLIAWaived.com
▪ Testing on-site and not just sample collection
and/or processing.
10
CLIA Application Hints and Tips
Certificate Renewal Process
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Frequency Types of Fees
Based on
Certificate Type
Survey verses
Certificate Fees
Certificate Fees*
12
▪ Certificate of Waiver (CoW) and Provider-Performed Microscopy
(PPM) Certificates
• CoW--$248 PPM--$297
▪ Certificate of Compliance (CoC) Certificate
• Certificate Fee--$223 and up Survey Fee--$446 and up
▪ Certificate of Accreditation (CoA) Certificate
• Certificate Fee--$223 and up Validation Survey Fee--$22 and up
▪ Certificate of Registration (CoR)
• One-time registration for labs applying for CoC or CoA
• Flat fee of $123 plus applicable Survey Fee for Initial Survey
*New Fee Schedule Effective January 27, 2024.
Reach out to your State Agency for current fee schedule.
CLIA Activities with Additional Fees
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▪ Lab adds a specialty and SA surveys outside of the CoC
survey cycle to determine compliance with new testing.
▪ State Agency (SA) performs a follow-up survey or revisit to
confirm correction of deficient practice found during a CoC
survey or a validation survey of a CoA lab.
▪ SA performs a complaint survey and the complaint is
substantiated.
▪ SA conducts a desk review of unsuccessful proficiency
testing performance.
Fee Payments FAQ’s
15
▪When can the Lab begin testing?
• Anytime after fees are paid and received by CMS
▪What form of payment does CMS accept?
• Checks sent in the mail
• On-line payments by Credit Card, Debit Card or
ACH Bank Account
• Note: Purchase orders are not accepted for
payment.
Fee Payments FAQ’s (cont.)
16
▪What happens if CMS does not receive
payment?
• Initial—CoW & PPM will terminate for non-
payment after 6 months.
• Renewal--Certificate will expire.
♦ Lab is unable to perform testing until payment is
received.
♦ May result in test reimbursement issues for lab.
Fee Payments FAQ’s (cont.)
17
▪Where can a Lab get an invoice?
• From CMS, not the State Agency
• CMS mails or e-mails (if Lab opted in for email
notifications) invoices directly 6 months before the
certificate expires—applies to CoW, PPM & CoA only.
• Important that the mailing or e-mail address for Lab is
up to date.
• Contact the State Agency for assistance.
Lab Changes that Require a CMS-116 Form
Submission within 30 Days of Change
19
Lab Director
Changes for
Most Certificate
Types*
Ownership Certificate Type
Reinstatement
or Reactivation
of Certificate
Adding a Multi-
site Exception--
including adding
Temporary Sites
Lab Changes that Only Require Written
Notification
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Laboratory
Name
Lab Location
Physical Address
Change
Mailing/Billing
and/or
Corporate
Address
Tax ID (EIN)
Specialty or
Subspecialty
Change
Total Test
Volume
Telephone or
Fax Number
Email Address
and/or Opt-in
for Email
Notifications
Accreditation
Organization
Multi-site
Information
Change
CoW Lab
Director
Voluntary
Closure or
Termination
Reinstatement
without Gap
Less than 6 Months
Technical
Supervisor
High Complexity
Testing
Lab Changes that Only Require Written
Notification (cont.)
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▪Acceptable Written Notification Formats:
• Email Preferred—Send to [email protected].
• Letter, Fax, CMS-116 Form
▪Must Include the Following Information:
• Laboratory Name
• CLIA Number
• Name of the Laboratory Director and/or Owner
• Change(s) and Effective Date
• If making changes for multiple CLIA certificates, may send
information on a spreadsheet.
Certificate of Waiver (CoW)
Laboratories
Anita Iwanski, Laboratory Certification Officer
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What are Waived Tests?
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▪ Tests that the FDA has categorized as waived testing complexity or
has cleared for home use.
• Must be simple to perform
• Have a low risk for an incorrect result
• Only performed on unprocessed samples
♦ Examples: whole blood, urine, specimen collected on a swab, stool, saliva
• Examples of waived tests include:
♦ Glucose meters, urine dipsticks, Covid antigen testing, fecal occult blood,
Prothrombin Time/INRs
♦ FDA Waived Analyte List
Waived tests are not completely error-proof.
To reduce the risk of erroneous results, train personnel to perform the test
according to the manufacturer’s instructions and provide a safe environment
where good testing practices are followed.
What are CLIA Requirements for
Performing Waived Testing?
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▪ Enroll in the CLIA program and obtain a Certificate of Waiver.
• Pay the certificate fee every two years.
• Notify State Agency (SA) of any changes as previously described.
• Allow inspections/surveys by a CMS agent, typically SA Staff.
♦ CoW Labs are not routinely inspected
♦ May be surveyed because of a complaint--unannounced
♦ Special surveys such as COVID public health reporting survey
▪ Follow the current manufacturer’s instructions for the waived
testing being performed.
Manufacturer’s Instructions
aka Package Insert or Instructions for Use (IFU)
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Intended Use Sample Collection and Preparation
Summary Test Procedure
Test Principle Interpretation of Results
Precautions Quality Control
Storage and Stability Limitations
Reagents and Materials Supplied Expected Values
Materials Required but Not Provided
Performance Characteristics
Manufacturer’s Instructions—Common
Components
26
▪ Intended Use, Summary, Test Principle
• Substance detected or measured
• Test methodology
• Diagnostic or screening a target population
• FDA cleared conditions for use—including professional use or self-
testing
▪ Precautions
• Alerts the user of practices or conditions affecting the test, potential
hazards and safety precautions.
• Ex: Read all instructions carefully before performing the test. Failure
to follow the instructions may result in inaccurate test results.
Manufacturer’s Instructions—Common
Components (cont.)
27
▪ Storage and Stability
• Recommended storage conditions—temperature and other
requirements (humidity, exposure to light) affecting reagent stability
• Ex: Store kit at 2-30°C (36-86°F). Kit is stable until the expiration date
marked on the outer packaging and containers. Ensure all test
components are at room temperature before use.
▪ Reagents and Materials Supplied
▪ Materials Required but Not Provided
• Ex: Clock, timer or stopwatch
• Ex: Materials Available as an Optional Accessory--Swab Transport Tube
Accessory Pack
Manufacturer’s Instructions—Common
Components (cont.)
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▪ Sample Collection and Preparation
• Detailed procedure for collecting the appropriate sample
• Handling and storage instructions
• Sample acceptability criteria
▪ Test Procedure
• Step-by-step instructions
• Information critical to correctly performing the test
• Ex: Note: False negative results can occur if the sample swab
is not rotated (twirled) prior to closing the card.
• Ex: Important: Ensure that enough blood is applied to fill the
check window and it turns red.
Manufacturer’s Instructions—Common
Components (cont.)
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▪ Interpretation of Results
• Instructions on how to read or interpret the test results
• Often includes visual aids and instructions for invalid result follow-up
• Ex: A positive specimen will give two pink/purple-colored lines.
Specimens with low levels of antigen may give a faint Sample Line. Any
visible pink/purple-colored line is positive.
• Ex: High Blood Glucose Readings
♦ If your blood glucose is above 600 mg/dL, you will receive a “Hi.” Repeat the
test with a new test strip. If this message shows again, contact your
healthcare professional immediately!
♦ Contact your physician for advice if test results are very high (above 240
mg/dL) and/or you have symptoms of high blood glucose. These symptoms
include dry mouth, thirst, frequent urination, nausea, vomiting, blurred vision,
sleepiness, or abdominal pain. Symptoms will vary person to person. You may
have one or all of these symptoms.
Manufacturer’s Instructions—Common
Components (cont.)
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▪ Quality Control (QC)
• Instructions for how and when to perform QC
• Use of Internal vs External QC
• Ext. QC Ex: Kits contain a Positive Control Swab and Sterile Swabs that
can be used as a Negative Control Swab. These swabs will monitor the
entire assay. Test these swabs once with each new shipment received and
once for each untrained operator.
• Ext. QC Ex: Before testing with the ReliOn® Confirm blood glucose meter
for the first time. Whenever you suspect the meter or test strips may not
be functioning properly. If test results appear to be abnormally high or low
or are not consistent with clinical symptoms. To check your technique.
When the ReliOn® Confirm blood glucose meter has been dropped or
stored below 32°F (0°C) or above 122°F (50°C).
Manufacturer’s Instructions—Common
Components (cont.)
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▪ Limitations
• Conditions that can affect test results—Disclaimers
▪ Expected Values
▪ Performance Characteristics
• Data and analysis for all the studies done to evaluate the test
performance.
Special Case: Glucose Meters in Assisted Living and
Residential Care Facilities
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▪ Who is doing the test and follow-up?—Glucose Meter Set-up,
Specimen Collection, Reagent Checks, Applying Specimen, Reading
and Interpretating the Result.
♦ Reads and Follows Manufacturer’s Instructions
♦ Follow-up for Error Codes and Abnormal Results
▪ Establish a Glucose Monitoring Process/Procedure for Your Facility.
♦ Maintain Glucose Meters and Reagents
– Manage Training of Staff on Manufacturer’s Instructions for Glucose Meters
Used in the Facility
– Reagent Strips Stored Correctly and Not Outdated
– Cleaning and Damaged/Broken Glucose Meters
– External QC Requirements
♦ Continuous Glucose Monitoring Systems
♦ Follow-up for Abnormal Glucose Results
Ready—Prepare for Testing
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▪ Designated testing area is well-lit with adequate space
• Maintain patient privacy (HIPPA)
• Safely provide testing—clean, dry, uncluttered, handy waste disposal
• Proper temperature and ventilation for testing
• Point-of-Care—consider bringing testing area to the patient on a cart
▪ Adequate inventory of reagents/kits and availability of required test
materials required but not supplied
• Reagents/kits stored according to manufacturer’s instructions
♦ Storage temperatures recorded and monitored for acceptability
• Consider purchasing inexpensive digital timers if test timing is required
Good Testing Practices
Ready—Prepare for Testing (cont.)
35
▪ Track shipments and expiration dates.
• Note “Receive Date” on packages.
• Discard expired reagents and kits.
• Make sure to not mix reagents from different kits.
▪ Use the Manufacturer’s Instructions supplied with the
reagents/kits.
• Check Manufacturer’s Instructions for changes with each new lot of
reagents/kits. Look at the version date.
• If changes, file old instructions with date retired and use new
instructions.
• Communicate changes in the Manufacturer's Instructions to other
testing personnel.
Good Testing Practices
Ready—Prepare for Testing (cont.)
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▪ Perform equipment maintenance and/or calibration checks as
required by the manufacturer’s instructions.
▪ Perform QC Testing and Track QC Results
• Internal QC results can be tracked along with the test result.
• External QC results can be tracked on separate QC log.
• Follow-up for Unexpected QC Results
♦ Manufacturer’s instructions followed? New Trainee? Change in
instructions?
♦ Reagents/Kits stored properly and not outdated?
♦ Follow troubleshooting steps in the manufacturer’s instructions
♦ Contact the manufacturer if unable to resolve. Have the lot number ready.
Good Testing Practices
Ready—Prepare for Testing (cont.)
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▪ Training and Documentation
• If more than one person will be performing testing, designate a
testing lead.
• Develop a Training Plan and Training Checklist
♦ Read the Manufacturer’s Instructions.
♦ Utilize on-line training resources provided by the manufacturer.
♦ Practice collecting the specimen as applicable.
♦ Perform the test with External QC and/or a practice sample.
♦ Review the entire testing process from test orders, patient preparation,
specimen collection, sample labeling, testing, result reporting and
documentation.
Good Testing Practices
Ready—Prepare for Testing (cont.)
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▪ Safe Work Practices
• Wear appropriate personal protective equipment (PPE).
• Clean hands and change gloves between patients.
• Follow OSHA guidelines for bloodborne pathogen exposure as
applicable.
• Do not eat, drink, or apply cosmetics in the testing area.
• Dispose of test materials according to Manufacturer’s Instructions.
• Disinfect work surfaces before performing any test procedure,
whenever there is visible contamination, and before leaving the
testing area.
Good Testing Practices
Set—Patient Preparation and Sample
Collection
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▪ Test Orders
▪ Patient Identification
• 2 Identifiers are best—Name and Birthdate as minimum
• Ask patient to confirm their identity
▪ Patient Preparation and Questions
▪ Sample Collection according to Manufacturer’s Instructions
▪ Sample or Device Labeling
• Label at the patient’s side
• 2 Identifiers are best
• Consider a unique sample/accession number (022124-1, 022124-2)
Good Testing Practices
Test—Testing and Reporting
40
▪ Testing is only done by trained testing personnel.
▪ Check the expiration dates of the reagents/kits in use.
▪ Check if QC needs to be done and complete if needed.
▪ Bring reagents/kits to room temperature as applicable. Inspect the
reagents/kits for damage or discoloration. Discard if found.
▪ Follow the current Manufacturer’s Instructions or Quick Reference
Guide in the kit and perform test on an acceptable sample.
▪ Record the test result on a Result Log—either paper or
electronically.
▪ Report results per procedure and only to authorized individuals.
▪ Maintain records for 2 years.
Good Testing Practices
Provider Performed Microscopy
(PPM) Laboratories
Angela Mack, CLIA Section Manager
41
PPM Procedures
43
▪ All direct wet mount preparations for the presence or absence of
bacteria, fungi, parasites, and human cellular elements
▪ All potassium hydroxide (KOH) preparations
▪ Pinworm examinations
▪ Fern tests
▪ Post-coital direct, qualitative examinations of vaginal or cervical
mucous
▪ Urine sediment examinations
▪ Nasal smears for granulocytes
▪ Fecal leukocyte examinations
▪ Qualitative semen analysis (limited to the presence or absence of
sperm and detection of motility)
NOTE: Under PPM, the testing site may also perform all waived tests
Who can perform PPM testing?
44
▪Physician
▪Mid-level Practitioner (Nurse Midwife, Nurse
Practitioner, Physician Assistant)
▪Dentist
All must be licensed by the State of Wisconsin
Registered Nurses (RNs), Medical Assistants (MAs), Medical Technologists
(MTs/MLSs) and Technicians (MLTs) are not allowed to perform PPM
testing under a PPM CLIA certificate.
Testing Personnel Training
45
▪ A Qualified Person should have Knowledge of:
• Microscope Use and Maintenance
• Accurate Performance of the Test(s)
• Good Laboratory Practices
• Safety Practices
♦ Universal Precautions
♦ Handling Hazardous Waste
♦ Appropriate Use of Personal Protective Equipment (PPE)
46
Training
Checklist
Example
Testing Personnel Competency Assessment
47
The following six procedures are the minimum regulatory requirements for
assessment of competency for all personnel performing testing:
1. Direct observations of routine patient test performance, including
patient preparation, if applicable, specimen handling, processing and
testing;
2. Monitoring the recording and reporting of test results;
3. Review of intermediate test results or worksheets, QC records, PT
results, and preventive maintenance and corrective action records;
4. Direct observations of performance of instrument maintenance
(microscopes) and function checks;
5. Assessment of test performance through testing previously analyzed
specimens, internal blind testing samples or external PT samples; and
6. Assessment of problem-solving skills
PPM Competency Assessment FAQ’s
48
▪ Do all six procedures of competency assessment
need to be performed at the same time each year?
• No, competency assessment can be done throughout the
entire year.
• Coordinate the competency assessment with routine practices
and procedures to minimize impact on workload.
▪ May I use Proficiency Testing (PT) performance to
assess competency?
• Yes, PT performance may be used as part of your competency
assessment; but use of PT performance alone is not sufficient
to meet all six required procedures.
PPM Competency Assessment FAQ’s (cont.)
49
▪ I am a sole practitioner and perform all of my own
laboratory testing; does CLIA require that I have
written policies for assessing my own competency?
• Need to establish a minimal level of proficiency to demonstrate
your competency
• Accomplished via proficiency testing or comparisons with a
peer entity
• Need to ensure that you maintain the required competency
PPM Competency Assessment FAQ’s (cont.)
50
▪ My laboratory performs only provider-performed
microscopy (PPM) and a mid-level practitioner
performs the testing; do I need to perform a
competency assessment on this person?
• Yes, if the individual is performing this type of non-waived
testing.
• The competency assessment should include all six elements.
Preparation and Equipment
51
▪ Adequate Space with Clean Work Surfaces and Good Lighting
▪ Privacy
▪ Flat Surface for Microscope
▪ Environmental Requirements such as Temperature and
Humidity
▪ Storage and Supplies
Test Order and Specimen Collection
52
Before Collecting a Specimen, Confirm:
▪ Test Order: Written or Electronic Order from Authorized
Person
▪ Patient Identification
SPECIMEN COLLECTION
▪ Specimen Type
▪ Collection Method
▪ Proper Labeling of Specimen
Performing the Test
53
▪ Test Procedures: Procedure manual must include specific
instructions for each PPM procedure.
▪ Quality Control: Perform as recommended per regulations
and laboratory policies.
▪ Recording Results: Need to be legible and reported in a
timely manner.
▪ Reporting Results: Only report to authorized persons and
document verbal reports which should be followed by a
written report.
Proficiency Testing (PT) and Quality
Assessment (QA)
54
▪ PT: Verifies accuracy and reliability of tests
• Lab must verify accuracy of testing at least twice per year.
• PT is a good tool to meet this regulatory requirement.
▪ QA: Lab must develop a quality system that includes an
ongoing QA component that monitors, identifies, evaluates,
and resolves problems as appropriate for PPM testing.
Document communication and complaint issues. Use
problems or issues to improve quality.
CLIA Resources
55
CLIA Resources
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• Standards and Certification: Laboratory Requirements (42 CFR
493)
• Survey Procedures and Interpretive Guidelines for Laboratories
♦ Also know as the State Operations Manual (SOM), Appendix C
• DHS Survey Guide for Clinical Laboratories
• CLIA Brochures
♦ How to Obtain a CLIA Certificate of Waiver
♦ What Do I Need to Do to Assess Personnel Competency?
• FDA CLIA Database—Test Complexity Look-up
60
CDC PPM Testing Resources
CDC PPM Testing
Webpage
▪ Provider-Performed Microscopy
Procedures
▪ Provider-Performed Microcopy
Procedures: An Introduction Online
Course
▪ CDC Basic Microscopy Online Course
▪ Basic Microscopy Training Videos:
• Microscope Components
• Setting up a Microscope
• Cleaning the Microscope
• Focusing the Microscope
CLIA Updates and Correspondence
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▪ DHS GovD CLIA Message
• Sign up to receive email notices about DQA and CMS CLIA
memos, DQA Quarterly Information Updates, and health care
policy-related information.
• Join our email list
▪ DHS CLIA Mailbox
• Email for all of your CLIA questions and correspondence.
Look for the sign-up on the DHS CLIA Webpage.
Questions and Answers
Angela Mack, LCCS Section Manager
63
▪ Forum I--November 29, 2023
▪ Certificate of Compliance (CoC)
Laboratory Survey Preparation
and Process Part I
• Survey Readiness and Organization
of Documents and Records for
Review
• CMS-116 CLIA Application and
CMS-209 Laboratory Personnel
Report
• Laboratory Personnel
Responsibilities and Qualifications
▪ Forum II--January 24, 2024
▪ Certificate of Compliance (CoC)
Laboratory Survey Preparation
and Process Part II
• CMS-2567 Statement of
Deficiencies (SOD), Immediate
Jeopardy, Response Requirements
and Commonly Cited Deficiencies
• Competency Assessment
• Proficiency Testing and PT Referral
• New Test Performance Verification
64
DHS CLIA Forums Webpage
Webinar Recordings and Presentation Slides Posted
65
