Kan. Admin. Regs. § 28-15-35f - Denial, suspension, or revocation of certification
(a) Certification may be denied, suspended,
or revoked, in whole or in part, if the secretary determines that laboratory
management committed any of the following violations:
(1) Failure to meet any of the requirements
specified in these regulations and
K.A.R.
28-15-36 or
K.A.R.
28-15-36a, as applicable;
(2) failure to demonstrate to an assessor
that the laboratory meets the required standards of certification based upon an
assessment;
(3) denial of entry to
a laboratory during normal business hours for an on-site assessment;
(4) failure to ensure that essential
laboratory personnel are available for participation, as needed, for the
satisfactory completion of any scheduled assessment;
(5) failure to respond to an assessment
report or to submit an acceptable corrective action report within the time
period as specified in 28-15-35c ;
(6) failure to implement any corrective
action approved by the laboratory certification officer;
(7) failure to participate in proficiency
testing studies as specified in 28-15-35d ;
(8) failure to successfully analyze and
report proficiency testing samples results as specified in 28-15-35d
;
(9) failure to pay the required
fees as specified in
K.A.R.
28-15-37 ;
(10) misrepresentation or omission of any
material facts in any information submitted to the department;
(11) any prior sustained charges of
administrative violations of state or federal laws and regulations related to
the provision of laboratory services or reimbursement for these services
against any laboratory management, individually or jointly, or against any
laboratory owned or directed by any laboratory management; or
(12) conviction for any crime related to
performance of laboratory services.
(b) In addition to the violations specified
in subsection (a), certification may be suspended by the secretary, in whole or
in part, if laboratory management fails to provide written notification to the
laboratory accreditation officer within 30 days of changes in the laboratory's
ownership, top management, essential personnel, location, or methods that
involve a change in technology or instrumentation.
(c) In addition to the violations specified
in subsection (a), certification may be revoked by the secretary, in whole or
in part, for any of the following reasons:
(1)
Repeated failure to comply with these regulations and
K.A.R.
28-15-36 or
28-15-36a, as
applicable;
(2) failure to maintain
corrective action implemented for citations repeatedly identified in
consecutive assessments; or
(3)
reporting as official compliance data any field of accreditation or analytical
result for which certification has not been granted by the
secretary.
(d) After
denial or revocation of certification, in whole or in part, the laboratory
shall be subject to the following requirements:
(1) The laboratory management shall
demonstrate to the laboratory certification officer that the deficiencies that
caused the denial or revocation are corrected.
(2) After the department notifies the
laboratory management that deficiencies causing the denial or revocation are
corrected, the laboratory management shall reapply for certification of the
affected fields of accreditation or submit a complete application to the
department, as applicable, before engaging in any practices requiring
certification.
(e) After
suspension of certification, in whole or in part, the laboratory shall be
subject to the following requirements:
(1)
Within six months of receiving notice of suspension or before expiration of the
current certification, whichever is longer, the laboratory management shall
demonstrate to the laboratory certification officer that the deficiencies that
caused the suspension have been corrected.
(2) If the laboratory management fails to
correct all deficiencies within the applicable timeframe established in
paragraph (e)(1), the laboratory's certification or fields of accreditation
affected shall be revoked.
(f) The laboratory management of a laboratory
for which certification has been denied, suspended, or revoked, in whole, may
request a hearing in accordance with
K.S.A. 65-1,109a and amendments thereto.
Notes
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