11/5/2015 David Antoon “PREVENT MEDICAL HARM” aka “Patient 32” is the goal of every harmed patient Patient Advocate * 20 Years 25 Years 8 Years 53 Years Commercial Military Aviation Patient Advocate Safety Aviation “Accidents Don’t Just Happen; They are Caused!” DISCLAIMER: All views, representations, statements or slides presented are solely the opinion of the presenter and * A New, Evidence‐based Estimate of Patient Harms Associated with Hospital Care not those of HealthWatch USA or any other entity. By James, John T. PhD WHO DOES THE DOCTOR/HOSPITAL HOLD THE GOAL OF EVERY HARMED PATIENT IS TO RESPONSIBLE? PREVENT HARM TO OTHERS Deny and Defend ‐ Blame the Patient! • Disgruntled Patient My COMPLAINTS: • Attack Patient Credibility False billing o • Informed Consent Medical harm to “staggering o number” of patients • Expected Complication Fraudulent Credentials • o Standard of Care Met No Credentialing o Alteration of Medical Records o Confidentiality! Insurance Fraud o Confidentiality! Ghost Surgery o Confidentiality! • Non‐invasive da Vinci robotic Prostatectomy Prevent Discovery The Patient is Responsible! No Patient Consent Form – “Patient Fully Aware of this Risk” PATIENT INVESTIGATION THE HARMED PATIENT “What Happened to me?” Where do I go? • Medical Records ‐ (Falsified, Altered, Withheld) Signed Informed Consent ‐ (disappeared) o Op Note: Copy and Paste Boiler plate written in 3 rd person not signed o Who can help me? Significant blood loss and complications concealed o All Progress notes written by 2 nd year resident ‐‐ not cosigned o OR Log and Audit Report show staff surgeon never present o Who will help me? Attestation Blank o Same day review of informed consent –blank o Surgical Time Out –Staff surgeon not present o Staff Surgeon performing “Concurrent Surgeries” beginning at the same time o • The Staff Surgeon Not Board Certified o Not Credentialed o Not Privileged o Many fraudulent credentials (including Iowa Medical License) o Consultant, Proctor, Lecturer for Intuitive Surgical o Not present at any time during surgery and hospitalization (Audit Report and OR Log) o • The Hospital o Marketed: “World Class Care” Ranked in Top 5 hospitals in the country o Independent Reviews: Bottom 7% of all hospitals surveyed Kaiser Family Foundation Review of CMS “Hospital Acquired Conditions” 98 out of 105 rated state hospitalsConsumer Reports first “D” rating ever issued by Leapfrog issued for patient safety 1
11/5/2015 CENTERS FOR MEDICARE MEDICAID OVERSIGHT AGENCIES SERVICES • Centers for Medicare and Medicaid Services (CMS) • Medicare Surveys ‐‐ difficult to initiate • HHS/Office of Civil Rights (HIPAA) • Courts • Institutions can be Too Big To Fail and have • State Department of Health • Insurance Companies repeated violations and multiple extensions • Ohio Insurance Commission • State Medical Board • American Board of Urology June 7, 2014 Modern Healthcare cover story “..Cases o • State Attorney General Highlight Flaws in Safety Oversight” * by Joe Carlson • Accreditation Council for Graduate Medical Education (ACGME) • Food and Drug Administration (FDA) • Accrediting Organization (Joint Commission) • Media – Investigative Reporters CENTER FOR MEDICARE AND MEDICAID SERVICES 7 CENTER FOR MEDICARE AND MEDICAID SERVICES 5 CMS Citations at one facility 13 March 2015 Do You Have A Right To Know If Your Hospital Is Unsafe? Media Reports 12 September 2015 BREAKING NEWS: Media Reports CIVIL MONETARY PENALTY The facility “was cited by CMS for violating Medicare rules more than three dozen times since 2010.”* Joe Carlson, Modern Healthcare, June 7, 2014 • Clinic fined $600000 for blood lab violations ModernHealthcare.com I facility in my treating hospital system was fined more than $600,000 for six serious violations by CMS. Jan. 21, 2010 Complaint Survey (PDF) • CMS report on the Hospital’s lab details systemic problems April 30, 2010 Full Survey (PDF) A 300‐page report from the Centers for Medicare and Medicaid Services (CMS) released Friday reveals Feb. 23, 2012 Complaint Survey (PDF) dozens of violations in procedure, training and July 30, 2012 Revisit Survey (PDF) CITED AS UNSAFE • The facility faces $650000 CMS fine Hospital lab violations, patients in ... Sept. 20, 2012 Complaint Survey (PDF) NO PUBLIC NOTICE ISSUED A 6‐month investigation of lab services by the Centers for Medicaid and Medicare Services has uncovered .. May 17, 2013 Complaint Survey (PDF) July 25 2013 Complaint Survey (PDF) • Federal report: Hospital patient blood lab tests filled with procedural errors CMS officials said the facility is already facing more than $600,000 in fines, and must have all issues at Sept. 26, 2013 Complaint Survey (PDF) the lab taken care of by Oct. 5, or face ... Dec. 12, 2013 Complaint Survey (PDF) • CMS fines hospital for lab deficiencies A CMS inspection found six serious violations of procedures that rose to the level of immediate jeopardy *Links to Nine Selected inspection reports finding violations at the same CITED AS UNSAFE IMMEDIATE JEAPARDY AND CONDITION LEVEL VIOLATIONS institutions NO FEDERAL PUBLIC NOTICE OF UNSAFE CONDITIONS NO PUBLIC NOTICE ISSUED LACK OF INFORMED CONSENT CMS Must Notify The Public HHS/OFFICE OF CIVIL RIGHTS The public has the right to know HIPAA when a termination notice has been issued. • COMPLAINT: • CFR 42 Section 489.53(d)(1): Records requested by Patient 32 withheld by o Timing: basic rule. Except as provided in paragraphs (d)(2) and (d)(3) of this Hospital section, CMS gives the provider notice of termination at least 15 days before the effective date of termination of the provider agreement. Termination effective dates are normally issued 90 days before the effective • RESPONSE: date. Please be advised that the Privacy Rule does not o • include specific requirements for the retention of CFR 42 Section 489.53(d)(1) medical records. Notice to public. CMS concurrently gives notice of the termination to the public . DESIGNATED RECORD SET is DEFINED BY THE o Concurrent Public Notice is NECESSARY to have Informed Consent HOSPTAL – There is NO STANDARD THIS DOES NOT HAPPEN! The Privacy Rule does not regulate the accuracy o or authenticity of medical records. 2
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