EXEMPT

CLASS I

PERMIT

CLASS II

PERMIT

CLASS III

PERMIT

HEALTH

SCREENING

(PROTOCOL)

LICENSE

ELIGIBILITY

CRITERIA

Single practice medicine, podiatry, dentistry or local health authority or designated agency

Single practice medicine includes:

M.D.s, D.O.s D.C.s [See Section 450.5(b)(1)]

Single practice medicine, podiatry, dentistry or local health authority or designated agency

Single practice medicine includes:

M.D.s, D.O.s D.C.s [See Section 450.5(b)(2)]

Owner where lab operated exclusively for  patients of physicians, podiatrists, or dentists who  own or are employed by the owner or local health authority or designated agency or Class I [See Section 450.5(b)(3)]

Owner where lab operated exclusively for  health screening for-profit basis either directly or indirectly

[See Section 450.5(b)(4)]

Any laboratory [See Section 450.1300(b)]

Owner to operate lab to accept specimens from any persons authorized to submit such specimens [See Section 450.5(b)(5)]

DIRECTOR

None

M.D., D.O., D.D.S., D.P.M., D.C., Ph.D., M.S., or Grandfathered who meets regulations [See Section 450.210(b)(1)]

M.D., D.O., Ph.D., M.S., or Grandfathered who meets regulations [See Section 450.210(b)(2)]

M.D., D.O., Ph.D., M.S., or Grandfathered who meets regulations [See Section 450.210(b)(3)]

Non-profit testing no requirements except a protocol For-profit testing Class III permit

M.D., D.O., Ph.D., M.S., or Grandfathered who meets regulations [See Section 450.210(b)(4)]

PERSONNEL OTHER THAN DIRECTOR (Minimum)

None

Laboratory assistant, if any [See Section 450.210(b)(1)]

Technician or Technologist

[See Section 450.210(b)(2)]

Technician or Laboratory Assistant [See Section 450.210(b)(3)]

None

General supervisor (if director not present full time) [See Section 450.210(b)(4)

FEES

None

Annual

Initial $50

Renewal $25

Annual

Initial $100

Renewal $50

Annual

Initial $200

Renewal $100

None

Annual

Initial $300

Renewal $150

INSPECTION

FREQUENCY

No mandated inspection

No mandated inspection

At least every 2½ years

At least every 2 years

No mandated inspection

At least annually

PROFICIENCY

TESTING

None

Required for tests offered [See Section 450.720]

Required for tests offered [See Section 450.720]

Required for tests offered [See Section 450.720]

None

Required for tests offered [See Section 450.720]

TEST PERMISSIBLE

List of minor tests [See Section 450.35(a)]

Minor and simple tests [See Section 450.35(b)]

Minor, simple and complex test [See Section 450.35(c)]

Cholesterol and glucose [See Sections 450.35(d) and 450.1300(a)]

Cholesterol and glucose [See Section 450.1300]

Any test as long as Director qualifies [See Section 450.35(e)]