Section 465.130 Certification Procedure

Section 465

TITLE 77: PUBLIC HEALTH

CHAPTER I: DEPARTMENT OF PUBLIC HEALTH

SUBCHAPTER e: LABORATORIES AND BLOOD BANKS

PART 465 CERTIFICATION AND OPERATION OF ENVIRONMENTAL LABORATORIES

SECTION 465.130 CERTIFICATION PROCEDURE

Section 465.130

Certification Procedure

a)         An environmental laboratory that meets or exceeds the minimum

criteria for certification may receive certification from the Department for

any microbiological parameter for which a methodology has been specified in

this Part or for which an alternative methodology has been approved in

accordance with the provisions of this Part.

b)         The operational aspects of an environmental laboratory that

will be evaluated in considering a request for certification are:

1)         laboratory facilities,

2)         personnel,

3)         methodology and instrumentation,

4)         data handling, and

5)         quality assurance program.

c)         In seeking initial certification, whether a new laboratory or

a certified laboratory requesting to analyze additional or newly regulated

contaminants, the petitioning environmental laboratory shall:

1)         Submit a formal request for certification to the Department;

2)         File with the Department on the applicable administrative

questionnaires furnished by the Department, if available, or otherwise in a

form approved by the Department, complete information on the five categories

listed in subsection (b);

3)         Analyze all proficiency testing samples (PTs) required in

accordance with the applicable Sections of this Part and report the results of those

analyses to the Department; and

4)         Permit and cooperate in an on-site visit by

Department-authorized certification officers.  Certification officers shall provide

the environmental laboratory with official identification and credentials.  The

initial visit will be arranged at the mutual convenience of both parties

ith the applicable Sections of this Part and report the results of those

analyses to the Department; and

4)         Permit and cooperate in an on-site visit by

Department-authorized certification officers.  Certification officers shall provide

the environmental laboratory with official identification and credentials.  The

initial visit will be arranged at the mutual convenience of both parties.  The

Department reserves the right to make subsequent visits without prior notice

during regular working hours.

d)         Initial approval or denial of certification may be made only

after the procedure described in subsection (c) has been completed.  If all

requirements of subsection (c) are satisfactory, initial approval will be

granted followed by a written narrative report.  Denial of certification shall

be in the form of a written narrative, giving information as to how

deficiencies may be corrected, along with a completed survey form on which all

deficiencies are clearly identified.

e)         Biennial audit approval or denial of certification may be made

only after the requirements described in subsection (b) have been assessed. If

all requirements of subsection (b) are satisfactory, approval will be granted

followed by a written narrative report. Denial of certification shall be in the

form of a written narrative, giving information as to how deficiencies may be

corrected, along with a completed survey form on which all deficiencies are

clearly identified.

f)         Environmental laboratories in jurisdictions not having

reciprocal agreements with the Department under Section 465.240 may receive

certification from the Department under this Part and shall pay all of the

expenses to be incurred by the Department, including travel expenses.