Sec. 10.10.08.05. Departmental Action — Reporting Erroneous or Questionable Patient Test Results

A. If the Department determines that a licensee has reported an erroneous or questionable patient test result that threatens the health or safety of the patient, the Secretary may order the licensee, within a specified period of time, to:

(1) Give prompt notice of the erroneous or questionable patient test result to the:

(a) Person who requested that the test be performed; and

(b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result;

(2) Provide corrected reports to the persons notified in §A(1) of this regulation;

(3) Maintain duplicates of both the original report and the corrected report;

(4) Conduct a quality assessment of all phases of the testing process to:

(a) Determine the cause of the erroneous or questionable test result; and

(b) Take the necessary remedial or corrective action to prevent recurrence of the problem; and

(5) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including:

(a) Notifying the:

(i) Patient;

(ii) Community at large if the Secretary determines that the licensee's laboratory operation is a threat to patient health and safety; and

(iii) If the licensee is unable to notify a patient, the Department; and

(b) Retesting:

(i) The same specimen;

(ii) A new specimen; or

(iii) Both the same specimen and a new specimen.

B. Civil Penalty for Failure to Comply with Order.

(1) A laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000.

(2) The Secretary may impose the civil penalty instead of or in addition to any other sanction imposed under this chapter.

C. Notice and Hearing.

(1) Notice. Before the Secretary imposes a civil penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to the licensee:

(a) Of the intent to impose a civil money penalty; and

(b) That the licensee has an opportunity for a hearing on the matter before the civil penalty is imposed.

(2) Content. The Secretary shall give written notice to the licensee of the:

(a) Reason for the imposition of the civil penalty;

(b) Amount of the civil penalty;

(c) Effective date of the imposition of the civil penalty;

(d) Time allowed for the licensee to respond to the notice; and

(e) Authority for imposing the civil penalty.

(3) Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this regulation or Health-General Article, §17-210, Annotated Code of Maryland.

(4) To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary's intent to impose the civil penalty.

D. Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil penalty is appropriate, the Secretary shall take into consideration the following factors in determining the amount of the penalty:

(1) The extent to which the licensee derived any financial benefit from reporting erroneous or questionable patient test results;

(2) The willfulness on the part of the licensee;

(3) The extent of actual or potential public harm caused by reporting erroneous or questionable patient test results;

(4) The cost of investigating and prosecuting the case against the licensee;

(5) The licensee's history of previous failure to meet the standards of this subtitle; and

(6) The existence of mitigating factors.

E. Payment of Penalties.

(1) At the Secretary's discretion, the Secretary may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment.

(2) All monies collected by the Secretary pursuant to this regulation shall be paid into the General Fund of the State.