Quality improvement initiatives: when is quality improvement actually a form of human subjects research?



Figure 33.1. Figure 33.1. Reproduced by permission from J. Sabin. Cost-containment ethics requires fiduciary trust of both physicians and institutions to disclose their summative integrity for patient care under rationing policies.


QI projects in this new world require new ethical/legal regulatory architecture. If there is to be privacy and confidentiality of shared information between patients and providers, then the Office of the National Coordinator for Health Care Information Technology (ONC) should publish the specifics of lawfully maintaining that privacy. QI activities requiring both collection and transparent data dissemination will be in conflict with existent regulations of the OHRP placed on present-day IRBs.

Plans to define efficiency and quality value performance will be morally challenged if quality measures defining payment of institutions and physicians are recognized as social policy experimentation that violates the existent Code of Federal Regulations (CFR). Such policy questions require review and revision of the Belmont Report structure for QI organizational ethics and law interpretations, since such issues were not existent when the Belmont Report was issued in 1979. Defining “meaningful usage” of the EMR in national health policy awaits the necessary regulatory revision. These conceptual issues are the major unknowns for people conducting QI activities in anesthesiology and acute care hospital medicine. Resolving these unknowns are prerequisite to integrating primary care and acute care databases under healthcare reform.

At the operational level, QI project design needs concrete definitions of “meaningful usage.”12 Meaningful QI projects need meaningful end-point definitions of quality in order to define enhanced payments to providers to accomplish those endpoints and to determine what performance data will be deemed of lower payment priority. Detailed definitional output from ONC is an urgent emerging national QI priority.

At the most basic clinical level, QI projects must ask “Will EMRs truly cut costs and find efficiencies without decrements in the quality and accessibility of care?” Contemporary EMRs provide major cost savings and revenue enhancements for billing and coding systems integrated into provider payments.13 Physicians clearly see computers as helpful when they facilitate rapid access to laboratory data and imaging diagnostic results. What has proved burdensome to patients and professionals is the time needed to properly enter computerized physician order entry (CPOE) and the nonmonetarized costs of added professional time.

Users of hospital computer information systems need ongoing real-time transparent flowcharts for ICU, emergency room, operating suites, and procedure area patients on hospital-based computers. The records must fulfill the seamless availability of ongoing minute-to-minute flow sheets to facilitate information transfer across shifts of individuals and nursing personnel to physicians. If these flow records cannot meet these standards of clinical necessity, they should be accounted for as quality and safety decrements in performance evaluation.

Future QI ethics projects will be more easily understood and rewarded when efficiency is properly measured and held financially accountable to maximize professional quality/time inputs and outputs.

A primary care physician in a remote office will need the same enhanced EMR time maximizing efficiency. Leveraging system productivity requires funded connectivity telemedicine applications in offices and patient residential sites that will permit physician extenders to leverage and maximize higher complexity decision-making activity by primary care physicians liberated from present-day documentation inefficiencies. Primary care physicians will need swift telemedicine consultation with specialists when necessary to efficiently solve chronic disease management issues in the home setting to prevent additional hospitalizations. Meaningful usage criteria here should carry the ability of the EMR to produce demonstrable cost savings and efficiency, on the one hand, while providing negative efficiency documentation of redundant functions not captured in deficient EMR hardware and software on the other.

Other nations have been implementing EMR integration with direct caregivers for several years. Successful smaller nations have required local integration. Vast data composites to assess the national productivity or net aggregate costs are a political imperative but will not offer a delivery cultural transformation. Smaller QI projects undertaken by QI analysts going forward will offer the necessary guidance to effect real change in individual services, hospitals and communities as a whole. Thus, the data-driven EMR, defined as “meaningful usage” will be fundamental in illuminating the legislative revision of CFRs and OHRP’s legal accountability in advancing efficiency, safety, quality, and privacy in clinical medicine.



Key points


Jan 8, 2017 | Posted by in ANESTHESIA | Comments Off on Quality improvement initiatives: when is quality improvement actually a form of human subjects research?

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