Current through Register Vol. 51, No. 19, September 20, 2024
A. Authority and
Types.
(1) The Secretary may impose one or
more principal or alternative sanctions.
(2) Principal Sanctions. The Secretary may
impose the following principal sanctions:
(a)
Denial of a license;
(b) Suspension
of a license; and
(c) Revocation of
a license.
(3)
Alternative Sanctions. Instead of or in conjunction with lifting a principal
sanction, the Secretary may impose one or more of the following alternative
sanctions:
(a) A directed plan of
correction;
(b) Limitation on
testing; and
(c) Training and
technical assistance.
B. Reasons for Imposition. A laboratory is
subject to the imposition of one or more sanctions when the OHCQ finds:
(1) A deficiency identified through an
on-site survey or a review of materials submitted by a laboratory, such as
applications data, personnel qualification materials, and self-inspection
checklists;
(2) Unsuccessful
proficiency testing performance;
(3) Demonstrated incompetence, such as
showing consistent or repetitive errors in operating equipment or in performing
a test or procedure;
(4) False
statements made on an application, plan-of-correction, or other form submitted
to the OHCQ;
(5) Misrepresentation
in obtaining a permit or letter of exception or in operating a
laboratory;
(6) Failure to comply
with the:
(a) Cancer reporting requirements
of Health-General Article, §18-204, Annotated Code of Maryland;
and
(b) Infectious disease and
submission of clinical material requirements of Health-General Article,
§18-205, Annotated Code of Maryland, and COMAR 10.06.01;
(7) Submission of a specimen by a
laboratory inside the State to another laboratory that does not possess a
license as set forth in COMAR 10.10.03;
(8) Conviction by a court of a violation of
the laws of the State pertaining to a medical laboratory; or
(9) Exceeding the 50 test per year limit when
operating under a letter of exception-limited testing for rare diseases as set
forth in COMAR
10.10.03.05B.
C. Factors Affecting
Choice of Sanctions. The Secretary shall choose which sanctions to apply to a
laboratory based on, but not limited to, the following:
(1) Whether a deficiency poses immediate
jeopardy to personal or public health or safety;
(2) The nature, incidence, severity, and
duration of the deficiency;
(3)
Whether a deficiency has been identified repeatedly;
(4) The inaccuracy or extent of missing
laboratory records, such as missing documentation of remedial action or failure
to make records available to the OHCQ;
(5) The relationship of one deficiency or
group of deficiencies to another deficiency;
(6) The overall compliance history of a
laboratory, including but not limited to any period of noncompliance that
occurred between determinations of compliance;
(7) The corrective and long-term compliance
outcomes the Secretary intends to effect through application of the sanction;
and
(8) The progress a laboratory
has made toward regulatory compliance following a reasonable opportunity to
correct a deficiency.
D.
Mandatory Revocation of a License. The Secretary shall revoke for 1 year the
license of a laboratory that intentionally refers a proficiency test sample to
another laboratory for analysis.
E.
Owning and Operating Prohibition Following Revocation. A person who has owned,
operated, or directed a laboratory that has had its license revoked may not,
within 1 year of the revocation, apply for a license, or own or operate a
laboratory for which a license has been issued under this chapter.
