West Virginia Code of State Rules
Agency 69 - Health And Human Resources
Title 69 - LEGISLATIVE RULE DEPARTMENT OF HEALTH AND HUMAN RESOURCES
Series 69-12 - Medication-Assisted Treatment - Office-Based Medication-Assisted Treatment
Section 69-12-13 - Reports and Records
Universal Citation: 69 WV Code of State Rules 69-12-13
Current through Register Vol. XLI, No. 38, September 20, 2024
13.1. Inspection Reports and Records.
13.1.1. The
secretary shall keep on file a report of any inspection, survey, or
investigation of an OBMAT program or any program sponsor, owner, employee,
volunteer, or patient thereof.
13.1.2. Information in reports or records
shall be available to the public except for the following:
13.1.2.a. Information regarding complaints
and subsequent investigations that is deemed confidential by any provision of
this rule or applicable state or federal laws;
13.1.2.b. Information of a personal nature
from a patient or personnel file; or
13.1.2.c. Information required to be kept
confidential by state or federal law.
13.1.3. A report of an inspection or
investigation made public shall also state whether a plan of correction has
been submitted to or approved by the secretary.
13.2. Statistical Reports and Records.
13.2.1. The OBMAT program shall file a
quarterly statistical report with the secretary on a form prescribed by the
secretary, which includes the following information:
13.2.1.a. The total number of patients
receiving medication-assisted treatment, broken down by gender;
13.2.1.b. The numbers of in-state patients
and out-of-state patients;
13.2.1.c. The number of patients admitted to
the program;
13.2.1.d. The number
of patients discharged from the program; and
13.2.1.e. The reason for discharge,
including:
13.2.1.e.1. Termination or
disqualification;
13.2.1.e.2.
Voluntary withdrawal; or
13.2.1.e.3. An unexplained reason.
13.2.1.f. The number of pregnant
patients.
13.3. Incident Reporting and Adverse Events.
13.3.1. Each OBMAT program shall develop and
implement policies and procedures for documenting, investigating, taking
corrective action, and tracking instances of known adverse events or
incidents.
13.3.2. Incidents or
adverse events may include:
13.3.2.a. Program
medication errors or other known medication errors where a patient suffers an
adverse effect;
13.3.2.b. Completed
patient suicide and suicide attempts;
13.3.2.c. Drug or substance-related
hospitalization of a patient related to the treatment being provided;
13.3.2.d. Patient death or serious injury due
to trauma, suicide, medication error, or unusual circumstances;
13.3.2.e. Harm to family members or others
from ingesting a patient's medication;
13.3.2.f. Selling drugs or substances on the
premises;
13.3.2.g. Medication
diversion;
13.3.2.h. Harassment or
abuse, including physical, verbal, sexual, and emotional, of patients by
staff;
13.3.2.i. Theft, burglary,
break-in, or similar incident at the program;
13.3.2.j. Physical violence leading to
injury;
13.3.2.k. Significant
disruption of services due to disaster such as fire, storm, flood, or another
occurrence; and
13.3.2.l. Incidents
that result in negative community reaction.
13.3.3. Incidents or adverse events shall be
reviewed on a quarterly basis by the medical director who may choose to make
recommendations to the administration, governing body or owner or owners and a
designated safety committee regarding the improvements in the process to
prevent further incidents.
13.3.4.
The program shall assure in the event of an incident or adverse event that:
13.3.4.a. The incident or adverse event is
fully documented and appropriately reported to the correct state agencies as
necessary;
13.3.4.b. There is
prompt investigation and review of the situation surrounding the incident or
adverse event;
13.3.4.c. Timely and
appropriate corrective action is taken; and
13.3.4.d. Ongoing monitoring of any
corrective action takes place until effectiveness of the action is
established.
13.3.5.
Within seven days of an incident or adverse event, the program shall file a
report with the state oversight agency consisting of the following:
13.3.5.a. The action or actions implemented
to prevent the reoccurrence of the incident or adverse event;
13.3.5.b. The time frames for the action or
actions to be implemented;
13.3.5.c. The person or persons designated to
implement and monitor the action or actions; and
13.3.5.d. The strategies for the measurements
of effectiveness to be established.
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