Clinical Research Management Training Program Electronic Medical Records: Access, Use and Compliance for Research March 11, 2013
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1 Clinical Research Management Training Program Electronic Medical Records: Access, Use and Compliance for Research March 11, 2013 Linda Metro, RHIA Director, Health Information Management
2 Electronic Medical Records Objectives Electronic Medical Records (Clinical Access vs. Research Access) HIPAA Regulations Pre-Planning and Study Feasibility Medical Record Content/Case Example IRB Medical Record Approvals including content review Clinical Trial Audits and Monitoring Visits
3 Electronic Medical Records: Clinical Access vs. Research Access Access/Limitations All employees of CN have access to our EMRs who have a need to know for business purposes such as Treatment, Payment and Operations (PTO) All employees sign a Confidentiality Agreement upon employment and businesses who sign a Business Associate Agreement (BAA) if working for CN under contract. All employees are bound by HIPAA Regulations for access and use Limitations- Not everyone can Print What are the systems and access levels? Depending of systems accessed Cerner (BearTracks) ecw (e Clinical Works- primary/adolescent care) EPRS or HPF (Electronic Patient Record System or McKesson s Horizon Patient Folder- specialty care)
4 Electronic Medical Records: Clinical Access vs. Research Access Roles/Training Options Job Roles/Responsibility: Clinician vs. Researcher Providers documenting with EMR or specific forms vs. View Only Some forms require the provider to co-sign while others do not Cerner: Must take competency test via CHEX & pass for access. Even with pre-training, on-site researchers often need extra help from the HIM Audit Coordinator. EPRS/HPF: Classroom setting through IT or CBT available but not mandatory. On-site researchers are given a small training class on how to navigate this system by the HIM Audit Coordinator. ecw: WBT available but not mandatory. To date, HIM has not been asked for data coming from this system.
5 Electronic Medical Records: Clinical Access vs. Research Access Who and What is restricted? Researchers from inside of CN: Access based upon clinical role for Treatment, Payment or Operations (TPO) RESEARCH IS EXCLUDED FROM HOSPITAL OPERATIONS. Need a separate authorization for research. Researchers from outside of CN: Access specific work queues with pre-determined case lists. This location is generally within the Health Information Management Department (HIM) at an off-site location in Silver Spring, MD. Researchers will have View Only access, no printing Keep in mind, most protocols discuss abstraction of data during the review process, therefore, printing is highly discouraged and rarely endorsed for multiple reasons.
6 Electronic Medical Records HIPAA Regulations What is HIPAA? Health Insurance Portability and Accountability Act A federal law that protects the privacy and security of identifiable health information- Effective April 14, 2003 Regulations apply unless state law provides more privacy protection for identifiable protected health information (PHI) PHI: paper, electronic or verbal Enforces standards for sharing and exchanging health information- Providers, Payers and Clearinghouses Requires authorizations for disclosures and accounting of disclosures
7 Electronic Medical Records HIPAA Regulations Patient Rights as defined by HIPAA Patient can inspect their PHI and get copies Exceptions: Psychotherapy notes On-going clinical trials (when the patient has been notified that access will be limited during the research specifically outlined in your Consent process) Patient can request amendments to the medical record Patient must be given full accounting of organization s disclosure of PHI Patient can request restrictions on disclosures Patient must receive Notice of Privacy Practices and Grievance procedure
8 Electronic Medical Records HIPAA Regulations Question: I sometimes serve as the principal investigator on a clinical trial. Can I still review my patient s records to determine which patients are good candidates for a clinical trial? Do I have to get an authorization first? Can I allow other researchers to review charts? Answer: HIPAA permits you to use and disclose protected health information for preliminary research activities such as developing hypotheses and recruiting research participants. Two exceptions: The researcher can only record de-identified information; and the researcher cannot remove PHI from the organization.
9 Electronic Medical Records Pre-Planning and Study Feasibility Developing Hypotheses Feasibility- report requests Where to begin- data abstraction Health Information Management (Medical Records) codes: Diagnoses and procedures Inpatients, Same Day Surgery and ED cases ICD-9-CM codes and CPT codes (STAR) Exception: Physician selection of SNOMED codes from May inpatients (Cerner) Date limitations- availability of data Health information-1997 and prior- microfilm/fiche
10 Electronic Medical Records Legal Medical Record Content EPRS/HPF Dates: current Scanned documentation from Inpatients, ER, Specialty Clinics, including data feeds from Lab, Pathology and Radiology reports. Same day surgery, Observation and ASC cases as well. Dates: 1998-current Cerner Dates: May 18, current Inpatient visits ER visits (both UMC and Main Campus) OPO, XOB (observation) ecw Dates: August current Primary care and Adolescent care visits from all sites. Backscanning of old documents are within ecw for the main campus for 2 years prior to go-live
11 Electronic Medical Records Legal Medical Record Content Clinical Trials vs. other Types of Records Registration Patient s in Clinical Trials are registered in McKesson s STAR system by Service type CTU and location is Main Clinical Trial Records Rule: NOT scanned into ecw or EPRS/HPF. Exception: Clinical Trial Informed Consents can be found within EPRS/HPF if sent to Health Information Management (HIM) and Oncology patient records. Informed Consent and Assents (barcoding/risk) ARE scanned into EPRS/HPF if sent to HIM Outside Labs ARE scanned into EPRS/HPF under Outside Documents if sent to HIM Privacy concerns (HIV status, paternity) Part of the general medical record if part of TPO Special Screening for Behavioral Health and Child Protection (special laws protect disclosure) Discoverability (court) Accountability
12 Electronic Medical Records Case Example Amy s medical record: Visit History Medical Service SDS Oncology Labs Pathology Radiology Psychiatry ER Child Protection Services Amy s research record: Consents Assents Labs- paternity Study Progress Notes Consents Discoverability and Risks of Leakage
13 Electronic Medical Records IRB Medical Record Approvals IRBear Protocol submission in designated application format with various reviews and predetermined approvals. Approvals from Medical Records Issue Ancillary Approval Medical Record Content Review: Section 5- Methods and Procedures: Data collection Section 8- Informed Consent Section 9: Data Privacy and Confidentiality Helpful Tips: De-identification of data, storage either paper or electronic and physical security of each whether locked cabinet or password protection with limited access, data abstraction methods Confidentiality including Consents and Assents (pre-established format that meets JCH criteria)
14 Electronic Medical Records Clinical Trail Audits and Visits Clinical Trial Audit Process and Visits Communication Clinical Researchers Director, HIM to check on status for approval in IRBear Content review (either approved via IRBear or back for pending concerns) CNMC Clinical Research Coordinators contact HIM s Audit Coordinator to set up date availability Pre-Education and additional assistance (collaboration) HIM s Audit Coordinator reserves audit booths for researchers and populates an electronic work queue for each auditor based upon the case list HIM coordinator obtains a Confidentiality Statement from each researcher On-site Audits and Common misconceptions No Copies of records for auditors while on-site All PCs are unable to print Access is limited to the scheduled audit time lines
15 Electronic Medical Records Access, Use and Compliance Questions Thank you
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