GEN.53400 Phase II
Does the technical supervisor meet the qualifications defined by CAP and
CLIA-88?
NOTE: The technical supervisor in each high complexity laboratory section
can be a licensed MD or DO with certification in anatomic and/or clinical
pathology, or qualifications equivalent to those required for board
certification. If the technical supervisor is responsible for anatomic
pathology then he/she must be certified in anatomic pathology or possess
qualifications equivalent to those required for certification. If the
technical supervisor is responsible for clinical pathology then he/she must
be certified in clinical pathology or possess qualifications equivalent to
those required for certification. If the technical supervisor is responsible
for both areas, then he/she must be certified in both anatomic and clinical
pathology or possess qualifications equivalent to those required for
certification. Alternate qualifications for the following specialty areas
can be found in Fed Register. 1992(Feb 28): 7177-7180 [42CFR493.1449]:
bacteriology, mycobacteriology, mycology, parasitology, virology, diagnostic
immunology, chemistry, hematology, cytology,ophthalmic pathology,
dermatopathology, oral pathology, radiobioassay, immunohematology.
CLIA-88 imposes additional requirements for the technical supervisors of the
histocompatibility and clinical cytogenetics services. These are found in
the Histocompatibility and Cytogenetics Checklists, respectively.
REFERENCE: Department of Health and Human Services, Centers for Medicare and
Medicaid Services. Clinical laboratory improvement amendments of 1988; final
rule. Fed Register. 1992(Feb 28):7177 [42CFR493.1449].
LABORATORY GENERAL Checklist
4/06/2006 Edition