CLIA: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) were established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results. CLIA applies to all laboratories that examine “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease” or “the assessment of the health of, human beings.”  (see 42 U.S.C. § 263a(a)). These examinations also include “procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body” (42 C.F.R. § 493.2).

CLIA and Research: Depending on the circumstances, research testing can be either exempted from CLIA or subject to CLIA. Most testing performed in the confines of ‘research’ at UCSF and affiliates falls under the domain and hence requirements of CLIA. Testing facilities may qualify to be exempted from CLIA certification if they meet the description of “research laboratories” provided by the CLIA regulations at 42 C.F.R. § 493.3(b)(2).

Included Under domain/regulations of CLIA (examples):

1. Testing is performed to determine eligibility for drug administration or invasive procedures (i.e., HCG, urine drug screen, hemoglobin, hematocrit, creatinine).
2. Testing is performed to determine which study arm study subject is enrolled in.
3. Testing performed and resulted in the study subject or individual involved in the study subject’s clinical care which has known clinical significance.

Not included under CLIA:

1. Testing performed on study subject-derived sample which is to be used solely for data analysis and will not affect the study-subject’s study interventions in any way

          AND

    2. Result of test NOT shared with patient and/or individual involved in study subject’s clinical care.

          OR

   3. Any facility or component of a facility that only performs testing for forensic purposes.

          OR

   4. Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets  SAMHSA guidelines and regulations. However, all other testing conducted by a SAMHSA-certified laboratory is subject to this rule.

 

  a) License: The lab must have a CLIA license appropriate for testing being performed*

  b) Lab Director Requirements: Federal and State law dictates the level of education and/or licensing requirements for lab directors*

  c) Test Operator Requirements: Federal and State law dictates the level of education and/or licensing requirements for test operators*

  d) Validation/Verification Studies: Federal and State law dictates components and frequency of validation/verification studies required*

  e) Operational requirements:

             i) Standard operating procedure with CLIA required elements signed by the lab director.

             ii) Training/competency documentation of test operators with content meetings CLIA requirements at intervals appropriate for testing being performed*

             iii) Quality control performed at the frequency required by manufacturer and/or CLIA*

             iv) Instrument maintenance performed as required by the manufacturer.

             v) Temperature monitoring of reagents, kits, and/or devices as required by the manufacturer.

             vi) Proficiency Testing if required*.

   f) Order/Resulting: CLIA complaint order and result documentation must be completed and retained for at least three years.

*Tests are designated a level of complexity by the FDA (waived vs non-waived (moderate complexity vs high complexity), and requirements are stricter for increasing complexity of testing.

 

***FOR A COMPREHENSIVE GUIDE ON THE STEPS INVOLVED IN POCT RESEARCH, KINDLY REFER TO OUR FAQs SECTION.***

Advisement:

Research involving Point of Care Lab Testing: POC testing falls under CLIA federal regulations. For more information regarding CLIA requirements as well as FAQ including how to proceed to ensure regulatory compliance, see CMS Regulations and Guidance Research Testing and CLIA. If research is to be conducted at UCSF Medical Center at Mission Bay, Mt Zion, or Parnassus, UCSF China Basin, UCSF Helen Diller Cancer Center, or UCSF West Bay Medical Center outpatient clinics, please fill out an intake form ASAP to ensure POC testing requested can be performed.

 

1. If using UCSF IRB, complete the IRB application, including Point of Care screening questions. If questions are answered in the affirmative, the study will receive advisement, which will include an online intake form for Point of Care studies included in the research study. Complete the intake form. UCSF POC team will contact you with follow-up communication regarding the next steps after the intake form is received and reviewed.
2. If using other IRB or if self-identified an already active study non-compliant with CLIA, complete online intake form for Point of Care studies if the following questions are answered in the affirmative.

Does your research study include laboratory testing performed on-site that is outside the main clinical lab or a send-out reference lab? (Y/N)

• If No, end of question.
• If Yes, ask:

       ☐  Does the result of the testing performed on-site alter care, including but not limited to determining subsequent study arm eligibility, drug administration eligibility, or invasive procedure eligibility?

       ☐  Will the result be shared with the participant?

• If No to both, no action.If Yes to EITHER [and West Bay UCSF Medical Center location], you may be redirected to our intake form.

What is Point of Care Testing?

When is Point of Care Testing done?

Will Point of Care Testing intake forms hold up or delay initial IRB approval of my study?

My ‘research’ testing appears to fall under the domain of CLIA. Who do I contact with questions and to seek guidance?

THE REST OF THIS FORM IS APPLICABLE ONLY TO UCSF WEST BAY LOCATIONS ON THE UCSF MEDICAL CENTER LICENSE.

Will I need to get a CLIA license?

I need to test for analyte X but need help deciding which testing kit/platform to use.

The study sponsor requires that a kit/device be used that isn’t already in use at UCSF for clinical care.

Who does the training/competency assessments?

Who does the quality control?

Who does the temperature monitoring?

Who does the Proficiency Testing?

Do I enter the results of the assay in the patient’s chart?

This FAQ references waived and non-waived lab testing. What is the difference?

The test I plan to use for my study is approved for home use. Does that mean that it doesn’t fall under CLIA?

Who can perform the point-of-care testing?

What is a general timeline for the implementation of a point-of-care test?

Is there a fee for using Point of Care Testing? If yes, who pays it?

I think I understand the requirements. What is the next step?

 

Q: What is Point of Care Testing?

Point-of-care testing (POCT) is a medical test performed near or at the patient's site of care, rather than in a centralized laboratory. POCT is also known as near-patient testing, bed-side testing, or rapid diagnostics.

Q: When is Point of Care Testing done?

Point of Care testing is performed when decreased turn around time (vs main lab testing) is required.

Q: Will Point of Care Testing intake forms hold up or delay initial IRB approval of my study?

No

Q: My ‘research’ testing appears to fall under the domain of CLIA. Who do I contact with questions and to seek guidance?

UCSF (UCSF West Bay and UCSF B-Oak) East Bay and its affiliate campuses (SFGH, SF VA) have designated Point of Care testing departments who are tasked with CLIA/CA regulatory oversight of Medical Center activities. If your testing will occur within a Medical Center location (aka. a building in which patients are seen for classic clinical care), it may be appropriate for your team to work with the site-specific POC team to ensure regulatory compliance; see below for contact information to discuss your case further. Alternatively, depending on the studies being conducted at which site, you may need to independently work to achieve regulatory compliance, including procuring your own CLIA license and following all CLIA requirements before study subject testing can proceed.

 

THE REST OF THIS FORM IS APPLICABLE ONLY TO UCSF WEST BAY LOCATIONS ON THE UCSF MEDICAL CENTER LICENSE.

Q: Will I need to get a CLIA license?

CLIA licenses are building/ address limited. Most UCSF West Bay Medical Center sites, including Parnassus, Mission Bay, and Mount Zion already have an existing CLIA license that covers duly approved point-of-care lab testing performed outside the main clinical laboratory. Each site's CLIA license is specific to the FDA-defined complexity of clinical testing presently being performed for classic clinical care at the site (waived, Provider Performed Microscopy, and non-PPM non-waived testing). Most outpatient sites have CLIA licenses which allow waived testing only. If the site already has a CLIA license appropriate for the complexity of testing you wish to perform (waived, PPM, non-PPM non-waived), you will be asked to interact with the CLIA lab director and get approval to add your requested testing to the site’s license (the POC team can facilitate the communication). If no lab testing is presently being done at the UCSF Medical Center location at which you plan to perform testing and hence no CLIA license exists yet, or the site’s license isn’t appropriate for the type of testing you wish to perform (i.e. you request non-waived testing but the license only allows waived testing), then a CLIA license will need to be obtained. UCSF’s POC team, in conjunction with UCSF’s Regulatory team, can help facilitate obtaining the appropriate licenses. 

Q: I need to test for analyte X but need help deciding which testing kit/platform to use.

UCSF West Bay’s POC team has already completed all required CLIA steps for many Point of Care tests. If the analyte you need to test for in your study is already in use for clinical care at UCSF, you are required to use that specific test kit/device and associated SOPs/training and competency forms/QC materials, etc. See http://poct.ucsf.edu/ for information regarding what clinical tests are already in use at UCSF West Bay (VPN or UCSF Internet needed and must view using Explorer/ Edge Browser). UCSF’s POC team also has worked to make available most of the testing kits on UCSF Bear Buy for easy purchasing (all POC components are also available on UCSF Medline for studies using Medical Center purchasing).

Q: The study sponsor requires that a kit/device be used that isn’t already in use at UCSF for clinical care.

If the analyte is already being tested using a Point of Care assay at UCSF, it is required that you use the kit/device already in place. This result will be considered the CLIA-compliant result. You will be allowed to run the sponsor-required assay in parallel; this parallel assay will not be required to be CLIA-compliant, but it is recommended that you closely follow all manufacturer recommendations including quality control frequency and temperature monitoring. If the CLIA-compliant assay and the non-CLIA compliant assay results agree, no further action is required. If the results don’t agree, then a sample should be obtained and sent to the main lab for further investigation; additionally, the POC medical director of UCSF West Bay should be informed of the discrepancy.

If the analyte is not already being tested at UCSF using a Point of Care assay, the study will need to request review/approval of the new test request by the UCSF POC Committee. See the new test request submission.  If determined to be necessary for the study and approved for use by the UCSF POC Committee, the POC oversight team at UCSF West Bay will work with the study team to determine the next steps. The UCSF West Bay POC team will work with the study team to ensure CLIA-complaint implementation. The service offered by the POC West Bay POC team may be recharged to the study budget; for more information regarding recharge rates, see here. For questions regarding which recharge rates might apply, contact UCSF West Bay Operational Lead.

Q: Who does the training/competency assessments?

If the testing is already in use at UCSF for clinical care and the location of testing is an outpatient UCSF Medical Center location, the UCSF Ambulatory Training Resource team will engage with you and arrange training/competency assessment and proper documentation. They likely will ask that you identify a superuser who can be trained and who will then train others on your team and complete and retain all required documentation (all documentation is to be retained for 3 years per CLIA).

If the testing is already in use at UCSF for clinical care and the location is an inpatient UCSF Medical Center location, the POC Oversight team will engage with you to determine who will be doing the training. They likely will ask that you identify a superuser who can be trained and who will then train others on your team and complete and retain all required documentation (all documentation is to be retained for 3 years per CLIA).

Q: Who does the quality control?

The clinic/unit performs the required quality control as required in the Standard Operating Procedure. UCSF’s POC team will provide the required QC logs. The clinic/unit retains the QC logs for the required 3 years.

Q: Who does the temperature monitoring?

The clinic/unit performs the required temperature monitoring of kits/reagents as required in the Standard Operating Procedure. The POC team/Ambulatory team will educate the team regarding what exactly is required. A NIST-certified thermometer is required for monitoring. The clinic/unit retains the temp monitoring logs for the required 3 years.

Q: Who does the Proficiency Testing?

Proficiency testing (PT) is not required for most waived tests. The exception to this requirement is HIV testing; the state of CA requires PT for all HIV testing. Proficiency testing is required for non-waived tests. The UCSF POC team will help enroll your site in the required PT testing if the analyte/assay is new to the clinic/unit. The normal clinic/unit operators will need to do the PT testing and result the findings.

Q: Do I enter the results of the assay in the patient’s chart?

Per CLIA, formal documentation of results is required. Because the results are ‘research’ however, and no patient billing should be triggered, it is important that the results are documented in a way that doesn’t trigger billing. If the study subject is registered in UCSF’s electronic medical record (APEX), it is recommended that the operator performing the assay fill out the appropriate ordering/resulting form and scan it into the electronic medical record (see Appendices). If the study subject is not registered in APEX, the operator performing the assay should fill out the resulting form and retain it for 3 years (duration required by CLIA).

Q: This FAQ references waived and non-waived lab testing. What is the difference?

The FDA reviews all data submitted by a manufacturer and classifies a test as waived or non-waived. Tests are classified as waived if they are simple to use and have little risk of incorrect results. Whether a test is classified as waived vs non-waived is important, as it dictates what license is required for the lab, what verification studies need to be performed on-site for the assay, who can perform the test, the composition and frequency of required training/competency,  the frequency of quality control, etc. For the most part, waived tests must, at a minimum, follow the manufacturer’s instructions. Most point-of-care kit-based tests are classified as waived. To investigate further, use the FDA CLIA searchable database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Q: The test I plan to use for my study is approved for home use. Does that mean that it doesn’t fall under CLIA?

A limited number of kit-based tests are approved for home use by the FDA. In that approval, the test must be performed only by the individual from whom the sample is collected (self-testing) and must use the home-use version with the home-use labeling and instructions. Once a test is brought into a health care facility and performed by an individual other than self, the test becomes CLIA-waived.

Q: Who can perform the point-of-care testing?

Per CLIA and California law, there are certain educational and licensure requirements to perform non-waived testing. Waived testing at UCSF can be performed by any individual involved in the individual’s direct patient care. Patient care coordinators and research coordinators can perform waived testing at UCSF in the outpatient setting with POC committee approval.

Q: What is a general timeline for the implementation of a point-of-care test?

It all depends on the test requested and whether a CLIA license already exists. A waived test already in use at UCSF can likely be implemented in 4-6 weeks if the site already has an appropriate CLIA license. If a waived testing CLIA license (called a Certificate of Waiver) needs to be obtained, it could take up to 4-6+ months as obtaining the license from CA CDPH can be a slow process. If the testing is waived but not already in use at UCSF, the POC team will need to generate the required materials, implementation may take up to 2-3 months. If the testing is not already in use at UCSF and is non-waived, if approved by the POC Committee, anticipate at least 6-8+ months for all required studies to be performed.

Q: Is there a fee for using Point of Care Testing? If yes, who pays it?

See recharge rates at POC and CLIA Research Website (Research Recharge Fees). If questions regarding which category of recharge is applicable, complete intake form and reach out to POC team for guidance. Research study funds are responsible for paying for recharge.

Q: I think I understand the requirements. What is the next step?

If the study is to be performed at a UCSF West Bay Medical Center location (a place under the UCSF West Bay Medical Center license that sees patients as well as research subjects), please fill out the UCSF West Bay Medical Center POC ‘Research’ testing intake form. Completion of the intake form will initiate review and engagement by the UCSF POC Regulatory oversight team and facilitate as expedited engagement as resources allow. The intake form will also be included in the IRB application advisement, if appropriate, but completion in advance of IRB application, if possible, is recommended. If there are questions as to whether the site where the study is to be performed falls under the UCSF Medical Center license, please reach out to the UCSF Regulatory team ([email protected]) and Cc ([email protected]). If the study is to be performed at a non-Medical Center site on the UCSF West Bay campus (i.e. School of Dentistry, Campus location), please work with that site’s leadership to ensure CLIA and CA CDPH regulatory compliance. https://www.cms.gov/regulations-and-guidance/legislation/clia

Appendix A: UCSF Referral Provider Requisition (Fillable)

UCSF West Bay Point of Care Testing Ordering/ Resulting Forms

Please use the appropriate form(s) for testing performed.

Appendix B: UCSF West Bay Point of Care Testing Ordering/ Resulting Forms - Manual Tests

Appendix C: UCSF West Bay Point of Care Testing Ordering/ Resulting Forms - Interfaced Devices

Appendix D: Monthly Self-Audit Form

 

References:

https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/research-testing-and-clia.pdf

https://www.cdc.gov/clia/test-complexities.html

https://www.cms.gov/regulations-and-guidance/legislation/clia

https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/FacilityLicensingHome.aspx

https://www.cdc.gov/labquality/waived-tests.html

https://barrins-assoc.com/tjc-cms-blog/hospitals/refresher-waived-testing-requirements/