SUMMERTIME LEARNING COMMUNITY - THEHEAT IS ON: REGULATORY REQUIREMENTS FOR DIABETIC RETINOPATHY SCREENING IN COMMUNITY CLINICS.August 22, 12:30 PM Pacific Daylight Time Call In Number: 800.747.5150 Access Code: 9438735 Jorge Cuadros, OD, PhD University of California, Berkeley Digital Health
QUESTIONS? Please select the “Raise Hand” button on your control panel, or send an instant message, email, or chat message during the conference We will un-mute your line & your question will be heard by the presenters & the group
TOPICS: HIPAA Requirements Credentialing Requirements ** FQHC’s and Scope of Service ** Procedures, Processes, and Protocols ** Telemedicine Consent Forms Other Regulatory Requirements: Please let us know your thoughts, advice, and questions! **Thanks to Missy Nitescu, COO, Northeast Valley Corp. and Karen McNerny, COO, Clinica Sierra Vista
HIPAA BUSINESS AGREEMENTS Rationale: to protect the privacy and integrity of confidential patient information (PHI). Who needs to do it? Clinics, UCB, and EyePACS may wish to include with service contracts. Features: Non-disclosure Mitigation Make information available to authorized requesters Make PHI policies available to authorized requesters Sample available at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/c overedentities/contractprov.html
CREDENTIALING READERS Rationale: Credentialing readers – security, liability, consistency Who gets credentialed? UCB and EyePACS credentials readers: Certification test Quality assurance Proof of liability insurance and licensure for panel readers JCAHO-certifiedhealth centers (20% of clinics) must use their own credentialing process to credential EyePACS readers who view their encounters.
SCOPE OF SERVICE RECOMMENDATIONS FORRETINOPATHY SCREENING (DRS) IN CLINICS: Addition of DRS qualifies for a scope of service (aka scope of project) change if it directly impacts the type, intensity, duration and amount of FQHC/RHC services. Costs for conducting DRS can be included in scope of service change not related to DRS (allowable under Medicare Reasonable Cost Principles). When adding a non-mandated service (eye care), it is required to justify how the additional service will result in improved health status for all patients. Imaging service vs. eye care service – guidelines are unclear.
PROCEDURES, PROCESSES, AND PROTOCOLS Rationale – Regulatory consistency, Guide for case managers, Consistent patient care. Committee initiates and develops protocols. Validation and use of data for research IRB Disclosures Prohibitions
TELEMEDICINE CONSENT FORM Patient Rights. It is understood that the patient participating in a telemedicine consultation may: Request that the participating doctor omit specific details of the history or examination that are personally sensitive. Limit any physical examination proposed during the telemedicine consultation. Request that nonmedical personnel leave the consultant’s location at any time. Request that all personnel leave the consultation site in order to have a private consultation with the off-site provider. Withhold or withdraw consent to this procedure without affecting rights to future care or treatment. Access all medical information transmitted during this telemedicine consultation, and obtain copies of this information for a reasonable fee. Is this really necessary? – Not Necessary as of May 1, 2011.
OTHER REGULATORY ISSUES: Data Backups Information systems: CCHIT guidelines FDA requirements 510 K Title 21 CFR Part 11 (electronic signatures and official copies) Validation Your Thoughts??