CMS issues CLIA guidance during COVID-19 public health emergency
On March 26, CMS issued a Memo to all CLIA State Survey Agency directors regarding CLIA guidance during the COVID-19 Public Health Emergency. The guidance took effect immediately. The memo and associated guidance are only applicable during the COVID-19 public health emergency and accredited labs must follow their accrediting organization requirements and applicable state laws, which may be more stringent than CLIA. Other than those elements set forth in the memo, all other CLIA regulations still apply. The memo provides ways in which CMS is trying to make it easier for labs to operate during the COVID-19 public health emergency.
The memo addressed the following areas:
1. Remote review of clinical lab data, results and pathology slides.
Although CMS has issued several blanket waivers and approved state 1135 waivers, CMS is not able to approve any waivers for CLIA program requirements. The 1135 waiver authority is only applicable to the programs authorized by the Social Security Act (SSA) and the CLIA program is not one of those. Because of this limitation, CMS is exercising its enforcement discretion to implement a temporary policy of “relaxed enforcement in connection with laboratories located at temporary testing sites” subject to the conditions outlined in the memo. CMS is exercising its enforcement discretion to ensure pathologists are allowed to remotely review pathology slides. CMS affirmatively states in the memo that it “will not enforce the requirement to have a separate certificate for laboratories that are located at a temporary testing site, provided that the designated primary site or home base has such a certificate (using the address of the primary site) and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate.” CMS explicitly declared that a pathologist’s home may be a temporary testing site.
If a lab chooses to utilize temporary testing sites, five criteria must be met:
- 42 CFR §493.3(a) basic rule that the lab must have current and valid certificates applicable to the category of examinations or procedures it performs
- Retention of slides, slide preparations, blocks and tissue remnants must comply with 42 CFR §493.1105(a)(7).
- Equipment and supplies for the temporary site are not kept there on a permanent basis.
- The temporary site must comply with other applicable Federal law, including HIPAA.
- Pursuant to 42 CFR §493.1251 the primary site must have a written procedure manual for all tests, assays and exams performed by the lab and the procedures must be followed by all lab personnel.
2. Expedited review of CLIA applications
Labs are required to have a CLIA certificate to perform COVID-19 testing. Accordingly, CMS will expedite review of CLIA certificate applications. Once a lab has identified a qualified lab director and provided all required information on the CMS-115 application form a CLIA number will be assigned. However, no requirements are being waived. Once the CLIA number is assigned, labs can begin testing as long as applicable CLIA requirements are met; labs will not have to wait for the hard copy paper certificate.
3. Labs located in contiguous buildings on the same campuses
Labs located in contiguous buildings on the same hospital or university hospital campus under common direction may hold a single certificate for all the lab sites within the same location or street address.
4. Proficiency Testing (PT) during a public health emergency
If a PT provider decides it needs to postpone or cancel a PT event during the public health emergency:
- The provider must immediately notify CMS, accrediting organizations, exempt states and participating labs. It must submit a plan for resumption of testing. CMS will not penalize labs for the absence of PT results if the cancelation or postponement is document and PT is timely conducted after the end of the public health emergency.
- “Only CMS may allow postponement, suspension, or cancelation of CLIA-required PT activities while patient testing continues.” A lab needs CMS permission to opt out of PT testing due to public health emergency.
- If CMS decides that PT should be postponed, suspended or canceled, then CMS will authorize use of reason code 10 by PT programs.
If a lab temporarily suspends performance of a specific test due to shortages of staff, supplies or reagent:
- The lab must document the timeframe during which the test is not being performed and the reason.
- The lab must notify the inspecting agency and PT program.
- PT is required if the lab is still performing or resumes testing and providing patient results.
- 5. Alternate specimen collection devices
CLIA regulations remain applicable during this public health emergency. CLIA requires that labs follow manufacturers instructions and if a lab modifies its process in a manner that diverges from those instructions, it must establish performance specifications and validate the assay prior to any patient testing. The lab director is responsible for defining the validation parameters. The FDA has posted additional information regarding its policy for modifications.
6. Laboratory developed tests (LDTs)
CMS again points to the FDA’s updated guidance from March 16. This guidance explains that states can choose to set up a system in which they take responsibility for authorizing these tests and the labs will not then engage with the FDA but the FDA requests that the states notify the FDA if it chooses to use this flexibility to expedite COVID-19 testing. CMS clarifies that labs performing LDTs as set forth in the FDA guidance are required to be CLIA certified and to meet the high complexity performance requirements.
To see a full copy of the memo and the related FAQs, click here.
For questions or further information please contact the attorneys below.