318:45-a Continuous Quality Improvement. –
I. Each licensed pharmacy shall establish a continuous quality improvement program (CQI). The purpose of the program shall be to assess errors that occur in the pharmacy during the review, preparation, and dispensing of prescription medications and to allow the pharmacy to take appropriate action to prevent or reduce the likelihood of a recurrence. The program is non-punitive and seeks to identify weaknesses in processes and systems, in order to make appropriate corrections to improve them.
II. A CQI program may be comprised of staff members of the pharmacy, including pharmacists, registered pharmacist interns, licensed advanced pharmacy technicians, registered pharmacy technicians, clerical staff, and other personnel deemed necessary by the permit holder or the consultant pharmacist of record.
III. A CQI program shall require that the permit holder or the consultant pharmacist of record ensure that a review of quality-related events occurs at least every 3 months, contain a planned process to record and assess quality related events, include a process for documenting actions to improve the quality of patient care, and maintain a summary of the documented actions. The review should consider environment and systems-based contributing factors.
IV. (a) The pharmacy shall either:
(1) Report incidents and unsafe events as quality-related events through a contracted patient safety organization (PSO) recognized by the Agency for Healthcare Research and Quality (AHRQ) whose primary mission is pharmacy continuous quality improvement; or
(2) Document incidents and unsafe events as quality-related events in an internal program in the pharmacy in a written record or computer database created solely for that purpose.
(b) The quality-related event shall be documented by the individual who discovers the event or the individual to whom it is initially reported. Documentation of quality-related events shall include a description of the event that is sufficient to permit categorization and analysis of the event. Pharmacies shall maintain such records at least until the event has been considered and incorporated in a summary of documented actions.
V. As a component of its CQI program, each licensed pharmacy shall assure that, following a quality-related event, all reasonably necessary steps have been taken to prevent or minimize patient harm.
VI. CQI programs shall be confidential. The summarization document shall analyze process improvements undertaken following a quality-related event. No patient names or employee names shall be included in this summarization. The summarization shall be maintained for 4 years and be made available within 3 business days of a request by the board's inspectors. Continuous quality improvement records shall be considered peer-review documents and not subject to discovery in civil litigation or administrative actions.
VII. The board may establish by rules adopted under RSA 541-A program requirements and recordkeeping requirements of a pharmacy CQI program.