W. Va. Code R. § 69-12-13

Current through Register Vol. XLI, No. 50, December 13, 2024

Section 69-12-13 - Reports and Records

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.

W. Va. Code R. § 69-12-13