Rough Transcript:
Webinar Access and Recording
You will have access to the webinar recording afterwards. It will be sent to you via email as soon as it is available, which should be quickly. We will also edit and share it later for anyone who didn’t get a chance to view it. Unfortunately, there are no PACE credits available for this webinar as we are all commercial consultants.
Chat Box and Resources
Please note the chat box. Keep an eye on it as we will be posting resources there throughout the presentation.
Participation Rules and Engagement
We have some participation rules to follow:
- Connect in the Chat: Please talk to one another, share thoughts, and introduce yourself. Take the time to be social.
- Stay on Topic: Ensure that your messages and questions are relevant to the current discussion to maintain focus and productivity.
- Be Clear and Concise: Keep your messages brief to avoid overwhelming the chat.
- Be Respectful: We aim to provide an inclusive environment that considers everyone.
- Constructive Contributions: Share your insights and ask questions that are pertinent to the topics.
Asking Questions
If you have questions for the presenter, use the QA chat box. On a laptop or desktop, you should see the QA chat box at the top. On a mobile device or tablet, select the three dots in the chat to find the QA box. Ensure that your questions go into this box for the presenter to see and answer.
Technical Issues
For technical issues, reach out to [email protected].
Schedule Overview
- HLA Compatibility Testing Updates
- New Personnel Regulations
- New Rules for Lab Director Responsibilities
We will pause for Q&A after each section.
Presenters
Your presenters today are Elena, Maria, and myself. Jay is our moderator, and Erid is in the background for technical support.
Presenter Introduction: Elena
Our first presenter is Elena. She has over a decade of clinical laboratory and leadership experience, specializing in compliance, quality, and leadership coaching. She founded Medical Laboratory Experts to empower lab leaders and address staffing shortages with training and a network of certified experts.
HLA Typing and Monitoring
Good morning, everyone. Thanks for attending. Today, we will cover updates in HLA typing, disease-associated studies, and antibody screening and identification.
- Continuous Monitoring: Labs are now required to install a continuous monitoring and alert system for HLA labs.
- Policies and Procedures: Labs must establish written policies for the storage and retention of PTI patient specimens based on the specific type of specimen.
- Antibody Technologies: Verbiage related to antibodies has been updated to allow for current and future technologies.
Personnel Requirements Updates
- Doctoral Degree Acceptance: The DCLS degree is now considered an acceptable doctoral degree, while the DVM degree has been removed.
- Training and Experience: Experience must be obtained in a CLIA lab. Forensic labs and research labs that do not report patient-specific results do not qualify.
- Directing or Supervising: Experience must be obtained in a CLIA lab, with teaching in an MLS or CLS program considered acceptable.
Laboratory Director Responsibilities
- On-Site Visits: The lab director must be on-site once every six months with documentation of visits.
- Technical Consultant Qualifications: CLIA is removing the qualification of a physical science degree and adding clinical lab science degrees.
Technical Consultant Qualifications Updates
- Clinical Lab Science Degrees: An earned doctoral, master’s, or bachelor’s degree in clinical lab science is now acceptable to qualify as a technical consultant, replacing the physical science degree.
- Associates Degree: Individuals with an associate’s degree in medical technology or clinical lab science and at least four years of lab training in a CLIA lab in non-waived testing and the designated specialty areas can qualify as technical consultants.
- Respiratory Therapy and Cardiovascular Technology Degrees: A bachelor’s degree in these fields from an accredited institution with at least two years of lab training or experience in blood gas analysis qualifies one as a technical consultant for blood gas testing only. This is beneficial for point-of-care departments, allowing for better competency management within those teams.
- Clinical Rotations: 18 months of clinical rotations during respiratory therapy or pulmonary technology school may count towards the required two years of lab training and experience.
Testing Personnel Requirements
- Removed Physical Science Degree: Physical science is no longer listed as a qualification.
- Nursing Degrees: An earned doctoral, master’s, or bachelor’s degree in nursing qualifies for moderate complexity testing but not high complexity testing. Nurses can no longer qualify as lab directors. Existing nursing degree lab directors are grandfathered in but must remain continuously employed in their positions.
Technical and General Supervisors
- Immunohematology Specific: Individuals with appropriate training and experience in immunohematology can qualify as technical supervisors.
- Delegation of Competency Assessments: Lab directors or technical supervisors can delegate semiannual and annual competency assessments for moderate and high complexity testing to technical consultants.
QA and Discussion
- Definition of a CLIA Lab: A CLIA lab must have a CLIA certificate. There are certificates of accreditation and certificates of compliance.
- PhD Qualifications: A PhD with fellowship training in clinical chemistry qualifies as long as it meets the specific CLIA requirements, which can be checked using the CLIA personnel grid.
- On-Site Visits: Lab directors must visit non-waived labs twice a year, with a minimum of four months between visits. This cannot be delegated.
- Bachelor’s Degree in Cardiovascular Technology: This typically refers to perfusionists and respiratory therapists.
- Nurses and Technical Consultant Roles: RNs can perform moderate complexity testing and qualify as technical consultants if they have the required experience.
- Respiratory Therapy Experience: Clinical rotations and past positions should be evaluated to justify the required two years of lab experience.
Presentation Conclusion
- Effective Dates: The changes discussed will take effect in January 2025.
- Upcoming Presentation: Maria Su-Aiera will now discuss revisions for labs under certificate of waiver and provider-performed microscopy procedures, fee changes, redesignations, and the effective dates for all CLIA changes.
Introduction to Maria Su-Aiera
Maria Su-Aiera, founder of Clinical Laboratory Scientist Consulting, will now present. She has advanced from a top board exam performer in medical technology to a lab manager role, pursued graduate studies, and is active in professional organizations.
Revisions for Labs Under Certificate of Waiver and PPM Procedures
- Background on Certificate of Waiver (CW): Currently, CW labs perform waived tests, which are simple and have insignificant risk for erroneous results. These labs are exempt from alternative sanctions but are inspected if a complaint is filed.
- Alternative Sanctions for CW Labs: CMS can now impose alternative sanctions, such as civil money penalties and on-site state monitoring, to improve compliance without significant economic impact. These sanctions provide flexibility and enhance oversight.
Changes to PPM Labs
- Midlevel Practitioners: Definitions now include registered nurse anesthetists and nurse specialists, allowing them to perform PPM tests.
- Competency Testing: The responsibility for competency assessment of testing personnel, including midlevel practitioners, is now explicitly assigned to the lab director.
Fee Changes for CW and PPM Labs
- Certificate Fees: The new fees for CW labs will be $248, and for PPM labs, $297, due to an 18% increase plus a biennial increase of 4.96% for inflation. CW labs will also pay $25 to the FDA for test determinations.
- Authorized Fees: Other fees include those associated with substantiated complaint surveys and replacement certificate fees.
Closing Remarks and Questions
Thank you for your attention. We will now take a few questions before moving on to the next presenter.
Q&A Highlights:
- CLIA Lab Definition: A CLIA lab must have a CLIA certificate, which can be a certificate of compliance or accreditation.
- PhD with Fellowship Training: Generally qualifies but should be verified against the specific CLIA personnel grid requirements.
- On-Site Visits for Non-Waived Labs: Must be done by the lab director and cannot be delegated.
- Respiratory Therapy Qualifications: Clinical rotations and previous lab experience should be evaluated to meet the required two years.
For further questions, feel free to email Elena, myself, or Maria. We will also be sharing the slides via email.
Introducing the Next Presenter: Maria Su-Aiera
Maria Su-Aiera will now take over to discuss the revisions for labs under certificate of waiver and provider-performed microscopy procedures, including fee changes and effective dates for the new regulations.
Certificate Fees and Projections
CMS is now charging replacement certificate fees for labs that have lost or damaged their original certificate and need a replacement. This encourages labs to handle their certificates more carefully. Additionally, there is a fee for revised certificates when information such as a change of lab director needs to be updated.
Projections for Other Authorized Fees
The table below outlines the projections for some of these fees:
| Fee Type | CW Labs | PPM Labs |
|---|---|---|
| Substantiated Complaint Survey | $2,059 | $3,858 |
| Replacement Certificates | $75 | $75 |
| Revised Certificates | $95 | $150 |
Redesignation and Renumbering of Provisions
CMS has redesignated and renumbered provisions to create space for new ones and to clarify existing ones. For instance, provision 493.646 is now redesignated as 493.655, which pertains to payment of fees. A new provision, 493.680, explains the methodology CMS uses to calculate biennial fee increases.
Effective Dates for Provisions
The provisions related to fees took effect on January 27, 2024. These provisions are hyperlinked for easy access to the Federal Register.
Provisions Effective December 28, 2024
These include the rest of the provisions that are not fee-related. These too are hyperlinked for easy reference.
Closing Remarks
These changes are aimed at preserving patient safety and ensuring accurate test results, ultimately benefiting the health of our communities. How ready are you for the CLIA changes?
Q&A Session
- Future Webinars: There will be more webinars and updates on CLIA changes. Please email us if there are specific topics you’d like covered.
- Technical Consultants in Moderate Complexity Labs: The qualifications and requirements are detailed in the links provided.
- CLIA Certificate of Waiver and PPM Changes: Any specific questions about these can be emailed to the presenters.
April’s Presentation on Economic and Historical Context of CLIA Fee Changes
April holds dual bachelor’s degrees in Biochemistry and Biotechnology, is a certified quality manager, and is active in the American Society for Clinical Laboratory Science.
Economic Context
- 18% Fee Increase: Implemented to fund annual program obligations and build an operating margin for CLIA. Future fee increases will be published by CMS in the Federal Register.
- Consumer Price Index: The fee increase is based on the Consumer Price Index for all Urban Consumers.
Historical Context
- Initial Fee Regulations: Established in February 1992, but not implemented due to confusion.
- 2022 Proposal: A new rule was proposed and approved to make fee structures clearer and more accessible.
Impact on Labs
- Fee Schedule: The new fee schedule is detailed in the provided documents. It covers issuing and revising certificates, replacing lost or damaged certificates, and fees associated with proficiency testing and complaint investigations.
- Accredited and Exempt Labs: Reach out to regulation advisors to understand how the new fees impact you.
Proficiency Testing (PT) Desk Review
Effective January 2024, PT desk reviews are triggered by unsuccessful scores, which means failing to attain a minimum satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two out of three consecutive testing events.
Definition of Unsuccessful Score
- Unsuccessful Score: Two unsatisfactory PT events within three consecutive testing events.
- Example: Failing potassium PT event one (unsatisfactory), passing event two (satisfactory), and failing event three (unsatisfactory) would trigger a PT desk review.
Next Steps
- Investigation and Plan of Correction: Laboratories must investigate the PT event, provide a plan of correction, and follow up on corrective actions.
Final Remarks and Resources
- Links and Resources: The provided documents contain all the necessary links and detailed information.
- Contacts: Email the presenters for specific questions or further information.
Next Steps for PT Desk Review
When a PT desk review is triggered due to an unsuccessful score, the laboratory must investigate the PT event and provide a plan of correction. There will be a follow-up assessment to ensure compliance and improvements by your CLIA director. This plan of correction will be reviewed, and you will be billed at an hourly rate of $111 for this desk review. If the review requires additional back-and-forth communication, you will be billed for all the work performed.
Failure to pay for your PT desk review can result in the limitation, suspension, or revocation of your CLIA certificate. It is crucial to understand the implications and take necessary actions to avoid these consequences.
Additional Fees
Starting this year, fees associated with the investigation of a substantiated complaint are billed at $111 per hour plus additional travel expenses. If a surveyor investigates a complaint and finds deficiencies, you will be charged for the time and travel expenses incurred. If the complaint is unsubstantiated, no fees will be charged. Note that a complaint does not trigger an outside-of-cycle survey unless there is a condition level non-compliance requiring a revisit inspection. This too will be billed at $111 per hour plus travel expenses.
Failure to pay these fees can result in the revocation, suspension, or limitation of your CLIA certificate. Always reach out to your state surveyors for assistance and clarification. They are there to help you succeed and improve patient care.
PT Desk Review for Regulated Analytes
The PT desk review applies to regulated analytes. While new target values and regulations are being introduced, only those analytes currently regulated will be subject to this review. Stay informed about the new PT test analytes and regulations as these will be continuously updated.
Delegation of Competency Assessment
For immunohematology, the delegation rules for competency assessment have not changed. Blood bank competencies remain under existing regulations. Delegation of semiannual and annual competency assessments for moderate and high complexity testing can be done, but blood bank-specific rules must still be followed. For manual differentials, the delegation applies as with other high complexity testing.
Questions and Clarifications
- Regulated Analytes Document: A document listing all regulated analytes will be provided. This will include new target values and analytes being added to the regulations.
- Proficiency Testing Resources: Resources such as the Westgard website and CMS documents are available for further information on proficiency testing.
Recap and Contact Information
Thank you for participating in today’s webinar. Here’s a quick recap of the topics covered:
- Regulatory updates
- CLIA fee schedule changes
- Certificate of waiver and PPM personnel roles and responsibilities
- New proficiency testing regulations
Nursing Degrees and High Complexity Testing
For those already qualified and employed in a lab director position with a nursing degree, they will continue to qualify under the new provision but must remain continuously employed in their position after the effective date. If they leave and want to return later, they will not be eligible.
CLIA received over 9,000 letters opposing the proposal to allow RNs to perform high complexity testing. The final ruling states that high complexity lab testing requires a higher level of knowledge, training, and experience, including troubleshooting, equipment maintenance, and interpretation and judgment skills, which RNs do not meet for high complexity testing.
Technical and General Supervisors
Individuals with a doctoral, master’s, or bachelor’s degree with appropriate training and experience in CLIA lab training can qualify as a technical supervisor for immunohematology. The physical science degree has been removed from supervisor qualifications. Lab directors or technical supervisors can delegate semiannual and annual competency assessments for moderate and high complexity testing to technical consultants.
Questions and Clarifications
Q: How is a CLIA lab defined and what is a CLIA accredited lab?
A: A CLIA lab must have a CLIA license, either a certificate of accreditation or a certificate of compliance.
Q: Do PhDs in biochemistry with fellowship training qualify under CLIA?
A: Yes, with the appropriate fellowship training, but check the specific CLIA grid requirements.
Q: Can the lab director visits be delegated to another lab personnel?
A: No, the lab director must visit twice a year with at least four months in between.
Q: Does a bachelor’s degree in cardiovascular technology refer to perfusionists or other fields?
A: It typically refers to perfusionists and respiratory therapy degrees.
Q: Will nurses who perform moderate complexity point-of-care testing for two years qualify as technical consultants?
A: The qualifications for RNs as technical consultants have not changed.
Q: How do you justify respiratory therapy with two years of lab experience?
A: Look at their clinical rotations and past positions to justify the required two years of lab experience.
Presentation Continuation
Thank you for your participation. The changes I discussed will take effect in January 2025, giving you time to prepare. Now, I’ll hand it over to Jay to introduce our next presenter, Maria.
Introduction to Maria Su-Aiera
Maria is a top board exam performer in medical technology who has advanced to a lab manager role. She has worked in microbiology, pursued graduate studies, and founded Clinical Laboratory Scientist Consulting. She is active in professional organizations for continuous growth.
Revisions for Labs Under Certificate of Waiver and PPM Procedures
Objectives
- Understand the benefits of alternative sanctions for labs under a certificate of waiver.
- Know the personnel changes for labs under a certificate for provider-performed microscopy procedures (PPM).
- Learn about the fee changes for issuance of certificates and additional fees for CW and PPM labs.
- Understand the rationale behind renumbering and redesignation of provision codes.
- Know which provisions are effective January 27, 2024, and those effective December 28, 2024.
Changes to Certificate of Waiver (CW) Labs
Currently, CW labs perform waived tests, which have little risk for erroneous results and are exempt from alternative sanctions but can be inspected if a complaint is filed. CMS has amended regulations to allow for alternative sanctions to improve compliance without significant economic impact. These include civil money penalties, directions on plans of correction, and on-site state monitoring.
Benefits of Alternative Sanctions
- Provide flexibility with less disruptive options for addressing compliance issues.
- Reduce administrative and operational burdens on labs.
- Enhance oversight with intermediate steps for correction, leading to better compliance and quality assurance.
Changes to PPM Labs
Major Amendments
- Midlevel Practitioners: Expanded to include registered nurse anesthetists and nurse specialists, allowing them to perform PPM tests.
- Competency Testing: Responsibility is now explicitly assigned to the lab director, including midlevel practitioners.
Fee Changes for CW and PPM Labs
Current and New Fees
- CW Labs: Currently pay $180, will increase to $248.
- PPM Labs: Currently pay $240, will increase to $297.
- FDA Fees: CW labs will also pay $25 for FDA test determinations.
Projections for Other Authorized Fees
- Substantiated Complaint Survey: CW labs will pay $2,059; PPM labs will pay $3,858.
- Replacement Certificates: Both will pay $75.
- Revised Certificates: CW labs will pay $95; PPM labs will pay $150.
Redesignation and Renumbering of Provisions
Provisions have been reorganized to allow space for new regulations and to reduce redundancy while maintaining thematic consistency.
Provisions Effective January 27, 2024
These provisions, which primarily concern fees, are already in effect.
Provisions Effective December 28, 2024
The rest of the provisions will take effect at the end of this year. These changes aim to enhance patient safety by ensuring accurate results.
Q&A Session
Q: Will there be more webinars or changes?
A: Yes, we plan to hold more webinars. Email us with specific topics you want covered.
Q: What about technical consultants for moderate complexity labs?
A: Refer to the published guidelines and links provided.
Conclusion
Thank you for joining us. We hope you found this information helpful. Stay connected and feel free to reach out with any questions.
Introduction to April
April holds dual bachelor’s degrees in Biochemistry and Biotechnology, is a certified quality manager, and is an active advocate in the American Society for Clinical Laboratory Science.
Economic and Historical Context of CLIA Fee Changes
Economic Context
- 18% Fee Increase: Implemented to fund annual program obligations and build an operating margin for CLIA.
- Consumer Price Index: Future fee increases will be based on this index and published for transparency.
Historical Context
- Initial Fee Regulations: Established in 1992 but not implemented due to confusion.
- 2022 Proposal: A new rule was approved to make fee structures clearer and more accessible.
Impact on Labs
The new fee schedule includes issuing and revising certificates, replacing lost or damaged certificates, and fees for proficiency testing and complaint investigations.
Proficiency Testing (PT) Desk Review
Effective January 2024, PT desk reviews are triggered by unsuccessful scores, defined as failing to attain a satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two out of three consecutive testing events.
Steps for Laboratories
- Investigation and Plan of Correction: Laboratories must investigate PT events, provide a plan of correction, and follow up on corrective actions.
Future Fee Increases
Future fee increases will be published by CMS in the Federal Register to ensure transparency. The calculation for the fee increase, which is about 5%, uses the Consumer Price Index for all Urban Consumers. This index will be reviewed every two years to determine if a percentage increase is necessary for CLIA fees and certificates. If there is a fee adjustment, it will be published. If not, there will be no publication, implying no fee increase.
Historical Context
The CLIA fee authority established in February 1992 authorized the collection of additional fees, but these were not implemented due to confusion among federal, contracted, and state surveyors. In 2022, a new rule was proposed to clarify and make fees more accessible. This rule was approved and is now implemented, allowing CLIA surveyors to charge these new fees.
Understanding the Cost
Here is the nucleus certificate fee schedule available in the shared document. Note the lab type, number of specialties and subspecialties, test volume, and whether you have a CLIA certificate of compliance or accreditation. Accredited labs will have 5% inspected by CLIA, and the revision of certificates will be slightly cheaper for these labs to ensure even costs across the board.
Additional Fees
Additional fees apply to issuing and revising certificates when there is a change in the laboratory director or other certificate details. Replacement fees for lost or damaged certificates remain at $75. Fees for proficiency test desk review related to unsuccessful PT performances are crucial and will be discussed further.
Fees for Substantiated Complaints
Fees associated with the investigation of a substantiated complaint are billed at $111 per hour plus travel expenses. If a surveyor finds deficiencies, you will be charged for their time and travel. If the complaint is unsubstantiated, no fees are charged. A complaint does not trigger an outside-of-cycle survey unless there is a condition level non-compliance requiring a revisit inspection, which will also be billed at $111 per hour plus travel expenses.
Proficiency Test Desk Review (PTDR)
Effective January 2024, PTDRs are triggered when a lab receives an unsuccessful score, meaning failure to attain a satisfactory score for an analyte, test, subspecialty, or specialty for two consecutive or two of three consecutive testing events.
Definition of Unsuccessful Score
An unsuccessful score includes two unsatisfactory PT events within three consecutive testing events. For example, if your first proficiency test event for potassium is unsatisfactory (less than 80%), and the second is satisfactory, but the third is also unsatisfactory, it triggers a PTDR. This process is continuous, so always be aware of your proficiency testing results.
Steps for Laboratories
When a PTDR is triggered, the laboratory must investigate the PT event, provide a plan of correction, and submit it for review. This review is billed at $111 per hour. Failure to pay the PTDR fees can result in limitation, suspension, or revocation of your CLIA certificate.
Additional Fees
If a surveyor investigates a substantiated complaint, you will be charged $111 per hour plus travel expenses. If the complaint is unsubstantiated, no fees are applied. An outside-of-cycle survey triggered by condition level non-compliance during the initial inspection also incurs fees.
Teamwork and Support
Remember, teamwork is essential. Your state surveyors are there to help you succeed. Reach out to them with questions and for guidance to navigate new information and improve patient care.
Q&A Session
Q: Is the PT desk review for all analytes or only regulated ones?
A: The PT desk review applies to regulated analytes. New target values and regulations will include new PT tests and analytes.
Q: How will delegation of competency assessments affect blood bank competency assessments and AABB adoption?
A: The changes apply to general lab directors. Blood bank rules have not changed, and AABB adoption may vary. For manual differentials, competency assessments can be delegated as with other high complexity testing.
Q: Are there documents listing the newly regulated analytes?
A: Yes, documents listing all regulated analytes and new target values are available. This information is shared through provided resources and will be updated continually.
Final Remarks
Thank you for joining us. We appreciate your time and participation. Stay connected and reach out with any further questions. This webinar has covered regulatory updates, CLIA fee schedule changes, proficiency testing regulations, and more. We hope you found it engaging and informative.
If you have additional questions, feel free to email us. A document containing all the necessary links and detailed information is available and will remain accessible until the end of the year. Thank you again for your participation.
