W. Va. Code R. § 69-11-14

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

Section 69-11-14 - Reports and Records

14.1. Inspection Reports and Records.

14.1.a. The Secretary shall keep on file a report of any inspection, survey or investigation of a MAT program or any program sponsor, owner, employee, volunteer or patient thereof.

14.1.b. Information in reports or records shall be available to the public except for the following:

14.1.b.1. Information regarding complaint and subsequent investigations that is deemed confidential by any provision of this rule or applicable state or federal laws;

14.1.b.2. Information of a personal nature from a patient or personnel file; or

14.1.b.3. Information required to be kept confidential by state or federal law.

14.1.c. 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.

14.2. Statistical Reports and Records. The MAT program shall file a quarterly statistical report with the Secretary on a form prescribed by the Secretary, which includes the following information:

14.2.a. The total number of patients receiving medication-assisted treatment;

14.2.b. The number of patients discharged from the program;

14.2.c. The state of residency of each patient;

14.2.d. The number of patients discharged from the program;

14.2.e. The total months the patients were in the treatment program prior to discharge;

14.2.f. Whether the discharge was for:

14.2.f.1. Termination or disqualification:

14.2.f.2. Voluntary withdrawal prior to completion of all requirements of detoxification as determined by the MAT program;

14.2.f.3. Successful completion of the individualized treatment plan of care; or

14.2.f.4. An unexplained reason;

14.2.g. Statistics demonstrating program compliance with the random drug testing requirements of paragraph 34.2.d.1. of this rule;

14.2.h. Confirmation that the random drug tests were truly random in regard to both the patients tested and to the times random drug tests were administered by lottery or some other objective standard so as not to prejudice or protect any particular patient;

14.2.i. Confirmation that the random drug tests were performed in accordance with the requirements in paragraph 34.2.d.1.;

14.2.j. The total number tested and the number of positive results; and

14.2.k. The number of expulsions from the MAT program.

14.3. Incident Reporting and Adverse Events.

14.3.a. Each MAT program shall develop and implement policies and procedures for comprehensively documenting, investigating, taking corrective action and tracking instances of adverse events or incidents.

14.3.b. Incidents or adverse events may include:

14.3.b.1. Program medication errors or other known medication errors;

14.3.b.2. Potentially lethal patient suicide attempts;

14.3.b.3. Drug or substance-related hospitalization of a patient;

14.3.b.4. Patient death or serious injury due to trauma, suicide, medication error or unusual circumstances;

14.3.b.5. Harm to family members or others from ingesting a patient's medication;

14.3.b.6. Selling drugs or substances on the premises;

14.3.b.7. Medication diversion;

14.3.b.8. Harassment or abuse, including physical, verbal, sexual and emotional, of patients by staff;

14.3.b.9. Theft, burglary, break-in or similar incident at the program;

14.3.b.10. Violence;

14.3.b.11. Significant disruption of services due to disaster such as fire, storm, flood or another occurrence; and

14.3.b.12. Incident with potential for negative community reaction or which the program director or medical director believes may lead to community concern.

14.3.c. Incidents or adverse events shall be reviewed on a quarterly basis by the advisory council which may choose to make recommendations to the administration, governing body or owner or owners regarding the improvements in the process to prevent further incidents.

14.3.d. The program shall assure in the event of an incident or adverse event that:

14.3.d.1. The incident or adverse event is fully documented and appropriately reported to the correct state agencies as necessary;

14.3.d.2. There is prompt investigation and review of the situation surrounding the incident or adverse event;

14.3.d.3. Timely and appropriate corrective action is taken; and

14.3.d.4. Ongoing monitoring of any corrective action takes place until effectiveness of the action is established.

14.3.e. Within seven days of an incident or adverse event, the program shall file a report with the state oversight agency on the incident or adverse event consisting of the following:

14.3.e.1. The action or actions implemented to prevent the reoccurrence of the incident or adverse event;

14.3.e.2. The time frames for the action or actions to be implemented;

14.3.e.3. The person or persons designated to implement and monitor the action or actions; and

14.3.e.4. The strategies for the measurements of effectiveness to be established.

14.3.f. The MAT program shall report any death involving drug overdose or drug-related complications to the state opioid treatment authority and the state oversight agency within 24 hours of the program receiving notification of the mortality.

14.3.g. A root-cause analysis shall be done for each incident or adverse effect.

W. Va. Code R. § 69-11-14