Current through Register Vol. 51, No. 19, September 20, 2024
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.
