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Healthcare Compliance and Contract Postition 12-18- 2014

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Healthcare Compliance and Contract Postition 12-18- 2014

  1. 1. Lori Michael Contact Tel : (952) 891-4845/ (952) 288-7069 e-mail : lorimichael12@gmail.com jonhockey1@juno.com jonhockey@frontiernet.net Address 8680 Hunters Way, Apple Valley, Minnesota 55124 Profile Objective Manufacturing compliance and regulation in a healthcare devices area. SKILLS and EXPERIENCE: Health Care Compliance and Regulation. Legal, Clinical Regulatory position in a corporate environment, utilizing my experience and skills in the area of healthcare, hospital and clinical/laboratory environment. Drafting and negotiating clinical agreements, implied consents, FDA agreements and regulatory requirements for clinical studies, including also areas that involve OSHA and HIPPA regulations. Transactional and contract agreements, including Stark and Anti Kickback Statute regulatory requirements, review of business agreements, and employment non-compete agreements. Utilizing MBA education in project management, development including budgets, drafts of clinical guidelines and project goals for product development and study enforcement and interpretation of HIPAA and FCPA. Manufacturing requirements as well as product compliance with FDA requirements and Guidelines for product approval/testing. Availability From December 2014. Key Skills Skills in the area of research and writing, Food and Drug Administration Regulations, HIPAA, Data Privacy Act, and other Federal and State laws and regulations as well as Federal and State rules of court. Strong medical knowledge of medical devices and their mechanics. Strong knowledge of medical testing devices, clinical knowledge of devices as well as familiarity with the FDA regulations that are used in compliance monitoring and approval. Strong medical background in the rhythm concerns and testing of medical devices as well as procedures for implantation; pharmaceutical testing and development as well as FDA- Food and Drug Law regulation. Drafted and negotiated a large amount of varied contracts, agreements, memorandums of law, and consent agreements for the Indian Community and their business enterprises, including Treasure Island Casino, one of the largest Native enterprises in the State of Minnesota, enforcement and interpretation of HIPAA in with tribal clinic and Indian Health Services. Variety of contract issues, including bids, purchase agreements and contracts, development proposals and contracts, federal contracts, and agency agreements, employment conflicts, covenants not to compete, jurisdictional issues, venue, intrastate and interstate as well as sovereign immunity to suit. On the average reviewed, drafted and negotiated over ten contracts per week. Negotiation of Code of Conduct Agreements, Clinical Testing and Reporting contracts, Negotiation of Medical Insurance Reimbursement contracts, and familiarity with Medicare requirements. Experience in clinical trials, medical requirements, consents and guidelines that control medical studies within the clinical cardiac catherization laboratory, hospital environment through cardiac rehabilitation studies, office clinical studies and the gathering of information from the physicians and patients that are involved in the studies. Broad understanding of medications, laboratory studies, cardiac studies, and sterile procedures, in the laboratory setting, training and utilization of the protections under HIPAA on a daily basis. Educated in Healthcare manufacturing investigative techniques for processing, six sigma and project management. Education 1996 to 2000 J.D. In Law Hamline School of Law, St. Paul, Minnesota. 2012-2013 Health Care Compliance Certificate from Hamline Health Law Institute, Hamline University.
  2. 2. 2014 Mini MBA Financial Management St. Thomas University, Minneapolis, Minnesota. 2014 Mini MBA Nonprofit Organizations, St. Thomas University, Minneapolis, Minnesota. 2007-2009 Healthcare Certificate/MBA Keller School of Business Management, Edina, Minnesota. 1975-1980 BA Co-ordinate Majors Biology/ Environmental Studies with Chemistry Minor Western Michigan University, Kalamazoo, Michigan. 2005 Certificate Program CVT Registry Spokane Community College, Spokane Washington. 2012-2013 Healthcare Compliance Certificate Program, Hamline Law School, Health Law Institute, St. Paul, Minnesota. Legal Work Experience Solo Practitioner Legal Legal Associates and Advocates LLC February 2007 to present  Solo Practitioner in the areas of Family Law, Criminal Law, Juvenile Law, Contracts, Probate and Wills/Trusts, Employment Law, Administrative Law, Bankruptcy, Appellate Practice and general practice issues.  Organized and Developed low bono and pro bono practice that serviced the Southern Counties in the State of Minnesota. Extended from Rochester-Olmsted County to Jackson County Minnesota. Worked through the attorneys in the area for referrals, as well as with Southern Minnesota Regional Legal Services (SMRLS) and Access to Justice LLC.  Performed all legal research and writing, drafting of pleadings and legal documents and attended all court hearings, and trials.  Appeals to the Minnesota Court of Appeals and the Minnesota Supreme Court.  Office in Apple Valley and Elmore, Minnesota. Contract Project Attorney Legal Mergis, Kelly Law Registry,Special Counsel, Robert Half and Lockridge, Grindal and Nauen PLLP. Minneapolis, MN February 2007 to present  Project attorney and document review attorney for large litigation and civil suits for large defense and plaintiff attorney groups in the City of Minneapolis. Medical and Healthcare Law, Employment Law, Patent Law, state regulatory issues and breach of contract litigation projects.  Experience in Multiple Document Review programs, Summation, Kroll ON Track, Catalyst, Concordance and Introspect as well as others.  Contract position for Medtronic in the legal department drafting contract agreements for clinical studies, and working with FDA requirements and Medicare guidelines for billing procedures. Drafted Medical Review Board proposals for studies and other medical agreement documents for device studies.  Contract position with the Minnesota Supreme Court, Court Services department. Review of legal questions submitted by the judges and district courts, regarding procedures and drafted memos stating their guidelines.  Drafted large excel spreadsheet for billing template for the district courts, PM and Misdemeanor fines including DNR fines and other administrative fines. Assistant General Counsel Criminal Prosecution/Family Law Prairie Island Indian Community, Welch MN March 2006-February 2007  Family law attorney for Indian Reservation, CHIPS, civil commitments, guardianships, and other family law issues. ICWA. And Tribal codes. Attended all court hearings and trials, in state and tribal court.  Prosecuting attorney for the Community, Ordinance violations. Appearances in state and tribal court.  Complex Native American and Environmental Law issues.  Transactional and Contract attorney for community and business enterprises, including Treasure Island Casino.  Drafted tribal ordinances and judicial codes.  Legal research and writing and reporting to tribal council regarding family law issues and Human Services Department.  Advisor for Indian Health Services-medical clinic on Prairie Island Indian Reservation, Welch, MN.
  3. 3. Temporary City Attorney Criminal Prosecution City of Rochester, Rochester, Minnesota June to November, 2005  Prosecution of misdemeanors, petty misdemeanors and gross misdemeanor DUI’s.  Charged Citations and drafted Complaints.  Negotiations between defendants and defendant’s counsel, Pleas and drafted Plea agreements.  Attended and participated in all court hearings and trials throughout litigation process.  Preparation of case, evidence collection and preparation of witnesses. Judicial Law Clerk Clerkship 10 th Judicial District Pine County, Minnesota Judge Krista Martin January 1, 2001 to March 2003.  Legal research and writing, including memorandums of law, orders, legal correspondence, jury instructions and judgments and decrees for district court judge. Managed the Pine County Law Library including the Premise Legal research Tool. Westlaw Research Tool used. Judicial Law Clerk Clerkship 1 st Judicial District LeSueur County, Minnesota Summer 2001 Judge Richard Perkins  Legal research and writing, including memorandums of law, orders, legal correspondence, jury instructions and judgments and decrees for district court judge. Divorce and Harassment Orders. Premise Research Tool. Law Clerk, Blue Dog Olson and Small LLP Law Clerk Bloomington, Minnesota 1998-2001  Legal research and writing for Native American law firm. Historical, land use and ICWA research. Complex issues such as sovereignty and constitutionality of ICWA, and analysis of the commerce clause and framers intent of regulation of Indian Tribes. Westlaw Research Tool. Anishinabe Legal Services Clerkship Minnesota Justice Foundation Summer Clerkship Program Summer 1998  Law clerk for Native American Legal Services, client intake services for White Earth, Leech Lake and Red Lake Indian Reservations, offered legal services under supervision of director. Handled client cases in conciliation court and employment disability hearing. Health Care Work Experience Fairview Southdale Hospital Cardiac Tech II 1996-2005  Monitored patients during non-invasive and invasive cardiac procedures, including angiograms, angioplasties, pericardial punctures for pericardial effusions, and other cardiac procedures. Also assisted the cardiologists as a surgical assistant in the same procedures, along with pacemaker and ICD implants. Clinical research record keeping and patient report compilations. Daily data input, and chart interpretation and record keeping.  Cardiology technician in the Cardiopulmonary Department performing EKG’s, scanning Holter Monitors and performing diagnostic stress test. Interpretation, dictation and report compilation for EKG’s, and Holter Monitors. Event Recorders for 24 hours and daily patient rhythm monitoring. Called Emergency assistant for patients if needed based on their recordings being submitted, and also sent information to physicians on call and otherwise. On call Cardiac Tech for Fairview Ridges Hospital performing stress testing and connecting patients to Holter scanners on the weekends. Equimed Cardiac Monitoring Service Cardiac Tech II 1997-1998  Monitoring of patients for 24 hour EKG and rhythm monitoring services. Event Recorders and single rhythm recorders for dental offices and other clinical offices. Interpretation of rhythms and EKGs, report compilations and contacting emergency services if needed, for patients sending emergent recordings.  EKG interpretation for American Dental Association yearly conferences, performed over three hundred EKG’s a day for a three day to a week conferences.
  4. 4. St. Paul Heart Clinic Cardiac Tech I 1994-1996  Performed stress tests, Pacemaker monitoring and telephonic checks for clinic patients daily, Scanned Holter Monitors, Diagnostic interpretation of the results and report compilation, Event Recorders and other diagnostic rhythm services, such QRS evaluation tests. St Josephs’ Hospital Monitor Clerk 1990-1994  Monitored Cardiac EKG rhythms for a 25-30 patient step down unit, for cardiac surgical patients and post heart attack patients, including end-stage and pulmonary patients. Interpretation and diagnostic reporting of EKG rhythms assisted Health Unit Coordinator with orders and answering phone when needed.  Utilized Medtronic, Cardio-med and other monitoring systems. Borgess Medical Center 1977-1990  Cardiovascular Exercise Technician  Electroencephalography Technician  Lab Technician  Monitor Technician Accreditations Legal Admitted to the Minnesota State Bar, October 2001. Legal Member of MSBA 2005-2012. Healthcare Management Healthcare Services Management Certificate 6/2008. MBA Keller School of Business Management 4/2009. Healthcare Compliance Certificate Program 2012-2013 Mini MBA Financial Management. Mini MBA NonProfit Organizations. Languages French (reading/ writing)

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