The laboratory director must match the leadership requirements for a laboratory.
Parameters affecting the complexity of the laboratory:
(1) highest CLIA complexity level in testing performed
(2) annual test volume
(3) number of specialities
|
Highest Complexity Performed |
Annual Test Volume |
Number of Specialties |
Tier |
|
high |
NA |
2 or more |
4 |
|
NA |
> 500,000 |
2 or more |
4 |
|
high |
NA |
1 |
3 |
|
NA |
> 500,000 |
1 |
3 |
|
moderate |
<= 500,000 |
NA |
2 |
|
waived or PPM |
<= 500,000 |
NA |
1 |
where:
• PPM = physician-performed microscopy
Parameters determining candidates qualifications:
(1) degree
(2) certification or license
(3) training
(4) experience running a laboratory
|
Degree |
Certificate or License |
Training |
Experience |
Tier |
|
MD or DO |
state |
board certified |
NA |
4 |
|
MD, DO, DPM |
state |
>= 1 year |
NA |
4 |
|
MD, DO, DPM |
state |
NA |
>= 2 years high complexity |
4 |
|
science PhD |
HHS |
NA |
NA |
4 |
|
MD, DO, DPM, PhD |
foreign country |
variable |
variable |
4 |
|
MD, DO, DPM |
state |
board certified in specialty |
NA |
3 |
|
MD, DO, DPM |
state |
>= 20 hours |
NA |
2 |
|
MD, DO, DPM |
state |
NA |
>= 1 year moderate or high complex |
2 |
|
science PhD |
NA |
NA |
>= 1 year moderate or high complex |
2 |
|
MD, DO, DPM |
state |
NA |
NA |
1 |
Specialty: Clinical Laboratory
