Welcome to the BMC2.org!
Funding for the BMC2 PCI-VIC CQI is provided by Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network (BCN). BCBSM’s Value Partnerships program provides clinical and executive support for all CQI programs. To learn more about Value Partnerships, www.valuepartnerships.com .
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The Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) is a collaborative consortium of health care providers in the State of Michigan which was created in 1997. BMC2 is comprised of 2 statewide quality improvement projects:
- A prospective multicenter statewide registry of consecutive percutaneous coronary interventions (BMC2 PCI)
- A prospective, longitudinal multicenter statewide registry of consecutive peripheral vascular interventions, vascular surgeries and carotid interventions (BMC2 VIC)
Both projects are designed to improve quality of care and patient outcomes.
The collaboration across BMC2 overcomes the barriers of traditional market and academic competition.
Both projects collect, audit and organize data and report procedural variables and outcomes to individual operators and institutions.
Generous financial support is provided to the BMC2 Coordinating Center, participating hospitals, to support the data abstraction costs and physician champions by Blue Cross and Blue Shield of Michigan and the Blue Care Network. This financial support is intended to make possible the participation in these quality improvement projects by eligible hospitals in Michigan.
The University of Michigan IRB has determined that because both projects are exclusively dedicated to quality improvement, both are exempt from the IRB regulation, 45 CFR Part 46.
Salient portion of the 45 CFR Part 46 Regulations and the FAQs:
Do the HHS regulations for the protection of human subjects in research (45 CFR part 46) apply to quality improvement activities conducted by one or more institutions whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes?
No, such activities do not satisfy the definition of “research” under 45 CFR 46.102(d), which is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” Therefore the HHS regulations for the protection of human subjects do not apply to such quality improvement activities, and there is no requirement under these regulations for such activities to undergo review by an IRB, or for these activities to be conducted with provider or patient informed consent.
Ensuring data quality:
- A select sample of all patient records submitted to BMC2 by participating sites are reviewed by data monitors during site visits to ensure definitions are understood and all data is being thoroughly and accurately abstracted/ case logs are reviewed for 100% case capture
- This is not a “data cleaning” exercise – this is monitoring for quality assurance
- All data entered for select outcomes are checked against the patient chart
- At least 10 cases per quarter cases are fully reviewed against the patient chart
- Errors are scored as “tier 1” (key quality indicators), or “tier 2” (all other data)
- Sites receive a score for each tier (exceeds, meets, does not meet) and a letter listing what was reviewed, scores and any systematic errors and need for improvement
- Most sites are visited multiple times per year
- Data monitors are RNs with Cath Lab and/or operating room experience working full time with BMC2
Additional ways that BMC2 ensures quality:
- All new data abstractors attend fact-to-face day-long training.
- The Coordinating Center hosts occasional conference calls with data abstractors to answer questions and to discuss data abstraction issues.
- The BMC2 website has an electronic means of submitting questions.
- Submitted questions are assigned to appropriate staff and monitored for timely answers.
- The Coordinating Center also hosts day-long face-to-face coordinator /data abstractor meetings twice per year.
History of BMC2 PCI
In 1996, 16 centers in Michigan were invited to participate in a multicenter PCI registry. The goals of the project were to develop risk-adjustment models for fatal and nonfatal outcomes of PCIs, to analyze practice variation in PCIs, to provide feedback to individual operators and institutions on absolute and risk-adjusted outcomes, to develop evidence-based standardized patient care guidelines, and to improve the quality of care of patients undergoing PCIs by sharing of information and a CQI process. Nine centers agreed to a pilot data collection and. A common data collection form and a standard set of definitions were developed, and a pilot 1-month data collection phase begun in July of 1997. After the pilot data collection the data form was further refined. The full data collection phase began in December 1997 and it has been ongoing since then.
Original BMC2 PCI Participating Hospitals:
- Spectrum Health, Grand Rapids
- St. Joseph Mercy Hospital, Ann Arbor
- McLaren Northern Michigan, Petoskey
- McLaren Regional Medical Center, Flint
- Harper Hospital, Detroit
- St. Joseph Hospital, Pontiac
- Henry Ford Hospital, Detroit, Michigan
- University of Michigan Health System, Ann Arbor
Dr. Mauro Moscucci, M.D., M.B.A.
Financial support for BMC2 PCI was provided by the Blue Cross and Blue Shield of Michigan Foundation. Dr. Mauro Moscucci, MD, led BMC2 PCI from inception through 2008. Dr. Moscucci is now the Chief, Division of Cardiovascular Medicine and the Senior Vice Chair, Department of Medicine for the University of Miami Health System.
He was assisted in this work by Eva Kline-Rogers, NP, Eva currently works as an NP and as manager for the Michigan Cardiovascular Outcomes Research and Reporting Program at the University of Michigan.
Eva Kline-Rogers, NP
Other key personnel who were involved with BMC2 during its early years were Dr. Kim Eagle (currently the Director of the University of Michigan Cardiovascular Center), Diane Bondie, Cec Montoye RN, Dean Smith PhD, & Dr. David Share, MD.