Questions

In this article, Dr. Sharon Ehrmeyer addresses frequently-asked-questions about CLIA'88, JCAHO, and CAP. This is an older article. Readers seeking the most up-to-the-minute information on regulations should check our CLIA series

• How many CLIA’88 certificates should my hospital have?
• Who will inspect me -- HCFA (for CLIA’88), JCAHO or CAP?
• The hospital is accredited by JCAHO. Will JCAHO inspect all laboratory testing?
• The hospital is accredited by JCAHO, but the central laboratory is inspected by CAP. Will CAP also inspect POCT?
• Will JCAHO accept CAP’s inspection?
• Will CAP accept JCAHO’s inspection?
• Why are CLIA’88 requirements important to me when my institutions testing is inspected by JCAHO or CAP?
• My JCAHO laboratory is in a state that has exempt status from HCFA. Do I still need to meet specific state requirements?
• All testing in my institution is inspected by JCAHO and several CLIA numbers are involved. As part of quality assurance, do we just need to compare results from different methodologies under the same CLIA number?
• I am a doctoral scientist without board certification and I direct a laboratory that does high complexity testing. The April 24, 1995 Federal Register extended the certification requirement to September 1, 1996. Can I still be the laboratory director?

How many CLIA’88 certificates should my hospital have?

This is entirely dependant on the situation; there is no right or wrong number. Some large institutions (greater than 1000 beds) have only one certificate while smaller institutions many have 20 or more. Most decisions are made along political lines -- who wants to be in charge.

Who will inspect me -- HCFA (for CLIA’88), JCAHO or CAP?

The Healthcare Financing Administration, usually through state inspectors, inspects for CLIA’88 compliance. Those testing sites not accredited by voluntary organizations such as JCAHO and CAP are inspected for CLIA compliance. Since most hospitals seek Medicare reimbursement which requires JCAHO accreditation, they would not be inspected by HCFA. Currently, HCFA inspects 35-40,000 testing sites.

The hospital is accredited by JCAHO. Will JCAHO inspect all laboratory testing?

Yes, unless some testing sites seek CAP or COLA (Commission on Office Laboratory Accreditation) accreditation. JCAHO will accept CAP and COLA inspections. If CAP inspects all of the testing in a JCAHO institution, JCAHO will, on a three cycle, inspect waived testing, since this falls under the standards for hospital accreditation. Usually only quality issues are addressed with this inspection.

The hospital is accredited by JCAHO, but the central laboratory is inspected by CAP. Will CAP also inspect POCT?

No, unless POCT testing is under the central laboratory’s certificate. CAP will only inspect POCT under a separate certificate when CAP accreditation is specifically sought.

Will JCAHO accept CAP’s inspection?

Yes

Will CAP accept JCAHO’s inspection?

No

Why are CLIA’88 requirements important to me when my institutions testing is inspected by JCAHO or CAP?

CLIA requirements are minimum universal requirements and form the basis of JCAHO and CAP requirements. For JCAHO and CAP to receive deemed status from HCFA, their requirements must meet (in essence) or exceed those of CLIA.

My JCAHO laboratory is in a state that has exempt status from HCFA. Do I still need to meet specific state requirements?

It is up to the individual states as to whether they will accept JCAHO accreditation. In most cases, laboratories will need to comply with both sets of requirements.

All testing in my institution is inspected by JCAHO and several CLIA numbers are involved. As part of quality assurance, do we just need to compare results from different methodologies under the same CLIA number?

No. JCAHO requires only one standard of care in the JCAHO accredited institution. In terms of laboratory testing, this means that results should be of similar quality throughout the institution. Therefore, whenever patients have the potential of having testing done at multiple sites within an institution, comparisons need to be made regardless of CLIA number. The testing site director(s) must decide on how close the results should be to best serve the clientele.

I am a doctoral scientist without board certification and I direct a laboratory that does high complexity testing. The April 24, 1995 Federal Register extended the certification requirement to September 1, 1996. Can I still be the laboratory director?

Yes. The deadline for board certification was extended to July 31, 1998, in the May 12, 1997 Federal Register.