10.22.02.03

.03 Investigation by the Administration.

A. This regulation sets forth the roles of the Developmental Disabilities Administration and the Office of Health Care Quality in investigation and follow-up of reportable incidents.

B. Licensee to be Open for Inspection. A licensee shall be open at all reasonable times to announced and unannounced inspections by the Administration or its designee.

C. Records and Reports. A licensee shall maintain records and make reports as required by the Administration. The records and reports shall be open to inspection by the Administration. A licensee shall immediately, on request of the Administration, provide copies of the records and reports, including medical records of individuals, to the Administration.

D. Protocol to Determine Necessity to Investigate.

(1) The Administration, through its agent, the Office of Health Care Quality (OHCQ), shall investigate reportable incidents, events, or problems involving individuals in a community agency or State residential center based on the scope and severity in accordance with the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.

(2) The licensee shall report incidents in accordance with the requirements and timelines outlined in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.

(3) The necessity for investigation is determined by the following priorities:

(a) Priority Level 1—Immediate Jeopardy—Initiate investigation within 2 working days of receipt;

(b) Priority Level 2—High—Initiate investigation within 4 working days of receipt;

(c) Priority Level 3—Other Harm—Initiate an investigation within 30 working days of receipt;

(d) Priority Level 4—Administrative Review—Review during preparation for licensee's annual survey;

(e) Priority Level 5—Referrals—Refer to internal OHCQ unit or appropriate agency for follow-up within 1 working day; or

(f) Priority Level 6—Death—Upon notification, refer to the Mortality Review Unit of OHCQ within 1 working day for review and investigation.

(4) Timelines for Specific Reports and Follow-Up Protocols.

(a) The licensee shall submit a plan of correction (POC) within 10 working days of the receipt of deficiencies. The POC due date may be sooner than 10 working days when the nature of the deficiency warrants a more immediate response, as determined by the OHCQ and as outlined in Appendix 6 of the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations.

(b) If the POC is determined to be acceptable, the OHCQ shall, whenever possible, within 10 working days of approving the POC, send the statement of deficiency and the POC to the:

(i) Licensee who is required to share this information with the individual receiving services, who is the specific subject of a deficient practice, or to the resource coordinator, a guardian, or a family member as appropriate and set forth in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations;

(ii) Complainant;

(iii) Agency's Executive Director and Board President;

(iv) DDA Regional Office;

(v) Maryland Disability Law Center when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations;

(vi) Medicaid Fraud Control Unit of the Attorney General's Office when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations; and

(vii) Any other parties determined to be appropriate by OHCQ.

(c) If the POC is determined to be unacceptable, the OHCQ shall, whenever possible, notify the agency in writing within 5 working days of receipt of the issues which require further review and consideration. The licensee shall resubmit to OHCQ a revised POC within 5 working days from notification of an unacceptable POC.

(d) OHCQ shall conduct follow-up monitoring in accordance with Developmental Disabilities Administration Policy on Reportable Incidents and Investigations.

E. Methods of Investigation. OHCQ shall conduct investigations through:

(1) On-site inspections;

(2) Interviews; or

(3) Reviews of relevant records and documents.

F. The licensee and OHCQ may receive extensions of the time periods set forth in this regulation for good cause shown.