CLIA
CLIA
Judith Yost
Director, Division of Laboratory
Services
CLIA and EHRs
CLIA
CLIA
CLIA and EHRs
Topics for Discussion
Applicable CLIA Regulations
Misperceptions Regarding CLIA
Clarifications of Misperceptions
New CMS Interpretive Guidance for
Laboratories & Surveyors
CLIA
CLIA
CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• §493.1105 Standard: Retention Requirements (a)(6)
Test reports. Retain or be able to retrieve a copy of the
original report (including final, preliminary, &
corrected reports) at least 2 yrs. after reporting.
• §493.1241 Standard: Test request
(a) The laboratory must have a written or electronic
request for patient testing from an authorized person.
CLIA
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• §493.1241 Standard: Test request
• (c) The laboratory must ensure the test requisition
solicits: (c)(1) The name & address or other suitable
identifiers of the authorized person requesting the test
and, if appropriate, the individual responsible for using
the test results, or the name and address of the
laboratory submitting the specimen, including, as
applicable, a contact person to enable the reporting of
imminently life threatening laboratory results or panic
CLIA
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• (c)(2) The patient’s name or unique patient identifier.
• (c)(3) The sex and age or date of birth of the patient.
• (c)(4) The test(s) to be performed.
• (c)(5) The source of the specimen, when appropriate.
• (c)(6) The date and, if appropriate, time of specimen collection.
• (c)(7) For Pap smears, the patient’s last menstrual period, and
indication of whether the patient had a previous abnormal report,
treatment, or biopsy.
• (c)(8) Any additional information relevant and necessary for a
specific test to ensure accurate and timely testing and reporting of
results, including interpretation, if applicable.
•
CLIA
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• §493.1291 Standard: Test report
• (a) The laboratory must have an adequate manual or
electronic system(s) in place to ensure test results and
other patient-specific data are accurately and reliably
sent from the point of data entry (whether interfaced or
entered manually) to final report destination, in a
timely manner. This includes the following:
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• §493.1291 Standard: Test report.
• (a)(1) Results reported from calculated data.
• (a)(2) Results and patient-specific data electronically
reported to network or interfaced systems.
• (a)(3) Manually transcribed or electronically
transmitted results and patient-specific information
reported directly or upon receipt from outside referral
laboratories, satellite or point-of-care testing locations.
CLIA
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• §493.1291 Standard: Test report
• (f) Test results must be released only to
authorized persons and, if applicable, the
individual responsible for using the test results
and the laboratory that initially requested the
test.
•
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CLIA and EHRs
Regulations for Test Ordering & Result
Reporting
• (k) when errors in the reported patient test results are
detected, the laboratory must:
• (k)(1) Promptly notify the authorized person ordering
the test and, if applicable, the individual using the test
results of reporting
errors.
• (k)(2) Issue corrected reports promptly to the
authorized person(s) ordering the test and, if
applicable, the individual using the test results.
•
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CLIA and EHRs
Misperception: Test results must be
retrieved/saved in the identical format as the
original report.
Clarification: No specific format is required,
but all required elements must be transmitted
accurately, reliably, confidentially & timely.
(493.1105)
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CLIA and EHRs
Misperception: CLIA requires both a paper &
electronic copy of results.
Clarification: No, CLIA only specifies 1 copy &
doesn’t require a certain method of saving.
(493.1105)
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CLIA and EHRs
Misperception: CLIA doesn’t permit patients
to receive test results directly.
Clarification: Depending on State law,
patients may be able to receive test results or
the authorized person may request a copy for
the patient when ordering the test. (493.1241
& 493.1291)
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CLIA and EHRs
Misperception: CLIA doesn’t permit test results
to go directly to an HIE.
Clarification: With the authorized person’s
designation or an order on the test request,
they can. (493.1291(a) & (f))
.
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CLIA and EHRs
Misperception: The lab’s responsibility is met
when the 1
st
entity receives the results.
Clarification: The lab is responsible for getting
the results to the authorized person who
ordered the test. Once they reach the
authorized person, the lab’s CLIA
responsibility is discharged.(493.1291(a)&(f))
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CLIA and EHRs
Misperception: CLIA requires visual
verification of result transmission to the
authorized person.
Clarification: CLIA doesn’t specify the
mechanism or frequency to check result
transmission. (493.1291(a))
Misperception: If all EHR interface software is
the same, it only needs to be verified once.
Clarification: ALL EHR interfaces & all
locations must be checked. (493.1291(a))
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CLIA and EHRs
Misperception: CLIA should compile the list of
LOINC codes & standard terminology, like
HL-7 & oversee the accuracy of EHR
vendor’s transmissions
.
Clarification: CLIA is user fee funded &
doesn’t have the authority to oversee these
entities, but HHS supports the use of this
standard terminology & transmission coding.
(493.1291(a))
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CLIA and EHRs
• Newly clarified CMS CLIA Interpretive
Guidance for EHRs is imminent!
– Contains expanded information, guidance
& regulatory interpretations for test
ordering, record retention & result reporting
– As applicable to the present state of EHRs
– Under the current
regulations!
• Will be accompanied by corresponding,
explanatory FAQs.
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THE END!!
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QUESTIONS??
