Kan. Admin. Regs. § 28-15-35f

Current through Register Vol. 43, No. 50, December 12, 2024

Section 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.

Kan. Admin. Regs. § 28-15-35f

Authorized by K.S.A. 65-1,109a; implementing K.S.A. 65-171l and 65-1,109a; adopted by Kansas Register Volume 43, No. 41; effective 10/25/2024.