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Monitoring Agency CMSa TJCb DOJc Investigation triggered by a Sentinel Event Sometimes Sometimes Always Routine and ongoing survey as part of conditions of participation Yes Yes No Compliance with federal regulatory standards for hospitals Sets and ensures compliance with conditions of participation Meets or exceeds CMS conditions of participation through establishment of elements of performance Establishes own standards Participation Voluntary Voluntary Involuntary Effect of hospital’s certification Deems hospital eligible to receive Medicare and Medicaid reimbursements Deems hospital eligible to receive Medicare and Medicaid reimbursements Prevents closure of hospital Hospital Expenses No payment for regulation Pays TJC a fee to be included in the survey process Pays DOJ consultants for ongoing monitoring of process until compliance with settlement agreement is reached Regulatory or survey process Collaborative Collaborative Adversarial Attorneys as part of team of investigators/surveyors No No Yes Investigation or survey based on court order or settlement agreement No No Yes Finite period of investigation or survey known at start Yes Yes Yes State and privately owned hospitals affected Yes Yes No (only state hospitals) Survey initiated as a result of a complaint Yes Yes Yes By 18 months from the effective Date hereof, CVHa shall develop and implement policies and/or guidelines to ensure system-wide monitoring of the safety, effectiveness, and appropriateness of all psychotropic medication use, consistent with generally accepted professional standards of care. In particular, policies and/or guidelines shall address: A. monitoring of the use of psychotropic medications to ensure that they are: 1.) specifically matched to current, clinically justified diagnoses; 2.) prescribed in therapeutic amounts, as dictated by the needs of the individual patient; 3.) tailored to each individual's clinical needs; 4.) monitored for effectiveness against the objectives of the individual’s treatment plan; 5.) monitored appropriately for side effects; and 6.) properly documented; B. monitoring of the use of PRN medications to ensure that these medications are clinically justified and administered on a time-limited basis, and not used as a substitute for adequate treatment of the underlying cause of the individual’s condition; C. monitoring of the use of benzodiazepines, anticholinergics, and polypharmacy to ensure clinical justification and attention to associated risks; D. appropriate use of psychotropic medications with attention to side effects; E. timely identification, reporting, data analyses, and follow up remedial action regarding adverse drug reactions reporting (“ADR”); F. drug utilization evaluation (“DUE”) in accord with established, up-to-date medication guidelines; G. documentation, reporting, data analyses, and follow up remedial action regarding actual and potential medication variances (“MVR”); H. tracking of individual and group practitioner trends, including data derived from monitoring of the use of PRNs, benzodiazepines, anticholinergics, and polypharmacy, and of ADRs, DUE, and MVR; I. feedback to the practitioner and educational/corrective actions in response to identified trends, when indicated; and J. use of information derived from ADRs, DUE, MVR, and providing such information to the Pharmacy & Therapeutics, Therapeutics Review, and Mortality and Morbidity Committees (Ref. 3, p 13–14) aCVH: Connecticut Valley Hospital.