Md. Code Regs. 10.10.08.02

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.08.02 - Departmental Actions - General

A. Deficiency Posing Immediate Jeopardy.

(1) If a laboratory's deficiency poses immediate jeopardy to personal or public health or safety, the Secretary shall take one or more of the actions listed in §A(2) and(3) of this regulation.

(2) Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall:

(a) Require the laboratory to take immediate action to remove the jeopardy; and

(b) Impose:

(i) A principal sanction after giving the laboratory at least 24 hours notice, or

(ii) One or more alternative sanctions.

(3) Follow-up Actions. If the OHCQ finds in a follow-up survey of a laboratory under an alternative sanction that the laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the laboratory at least 24 hours notice.

B. Deficiency Not Posing Immediate Jeopardy.

(1) If a laboratory's deficiency does not pose immediate jeopardy to personal or public health or safety, the Secretary may take one or more of the actions listed in §B(2)-(4) of this regulation.

(2) Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction.

(3) Unsuccessful Proficiency Testing. If a laboratory exhibits unsuccessful proficiency testing, as set forth in COMAR 10.10.01.03B, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction.

(4) Follow-up Actions. If the OHCQ finds in a follow-up survey that a laboratory has not corrected a deficiency within 30 days after it was identified, the Secretary may:

(a) Impose, or continue if already imposed, one or more sanctions;

(b) Conduct one or more on-site visits to evaluate progress in correcting a deficiency; and

(c) Conduct an additional follow-up survey to determine whether all corrections have been made.

C. Duration of a Sanction. A sanction shall remain in force until:

(1) A laboratory corrects the deficiency; or

(2) A laboratory's license is revoked.

D. Lifting of a Sanction.

(1) General Rule. The Secretary may not lift a sanction until regulatory compliance is verified.

(2) Credible Allegation of Compliance. When a sanctioned laboratory submits a credible allegation of compliance, the Secretary shall:

(a) Determine compliance on the basis of the evidence submitted by the laboratory in its allegation;

(b) Conduct a follow-up survey to verify whether the laboratory has achieved compliance; or

(c) Both §D(2)(a) and (b) of this regulation.

(3) If a laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license.

Md. Code Regs. 10.10.08.02

Regulation .02A, B amended effective June 1, 2009 (36:11 Md. R. 787)