Compliance Policy C-FMS Clinical Research Project Approval Application
|
|
- Garey Patterson
- 5 years ago
- Views:
Transcription
1 Internal Use Only: Business Unit: Fresenius Medical Services Region: RVP: Area Manager: Facility # Compliance Policy C-FMS of Investigator or Study Coordinator completes the following: Facility Name Street Address City, State, Zip Clinic Manager Facility Number Telephone Number Fax Number Study Title Protocol # (if applicable) Sponsor Principal Investigator PI Telephone PI Duration of study subject s participation Study Coordinator PI Fax Study Coordinator Please attach the following documents (please note failure to complete/provide the following could lead to delays in approval) Study protocol (abstracts not accepted) Approval statement from Institutional Review Board (if applicable) Signed copy of 1572 Study specific Patient Informed Consent template, including disclosure of financial reimbursement to physician, staff and facility. Overhead Fee or Application Fee (for investigator initiated or non-profit entities only) Study materials, if any, used for patient recruitment Study specific FMC HIPAA Privacy Authorization template, if consent is not HIPAA compliant (see Attachment 2) Lab contract OR Name of Central Lab: Investigator Statement (Page 2 of Application) Page 1 of 6
2 Fresenius Medical Services Compliance Policy C-FMS Please complete the following: Investigator Statement Investigator s Name: Name of Study: Please check one answer for each statement: 1. Investigator will ensure that the conduct of the study complies with all applicable local, state and federal laws and regulations. 2. Investigator will ensure that all study participants are fully informed of the study and sign an IRB approved consent form. 3. Investigator will promptly inform Sponsor and Institutional Review Board of any Serious Adverse Events. 4. Investigator assures FMCNA that no facility staff will be used in the conduct of the trial. 5. Investigator assures FMCNA that no study labs will be billed to the patient s insurance provider. 6. Investigator assures FMCNA that no dialysis facility supplies (including syringes etc.) will be used for research purposes. 7. Investigator will not change patient s dialysis schedule or delay patient s dialysis treatment for the study. 8. Investigator will make sure that they and their research staff have undergone appropriate training in research.* 9. If Investigator decides to publish study results, Investigator will provide FMCNA with the manuscript two (2) months prior to submission. 10. Investigator will reimburse FMCNA for any lost revenue which occurs as a result of patient participation. 11. Investigator will ensure that approval for study participation has been obtained from study patient s attending physician. 12. Other Yes No N/A Investigator Signature Study Coordinator Signature Date Date * A suggested link to a website for free training in the protection of human participants in research is as follows: Page 2 of 6
3 Internal Use Only: Fresenius Medical Services PI Study Compliance Policy C-FMS To be completed by Investigator or Study Coordinator at Time of Initial Application for Project Approval 1. Are the labs, medications or services needed by the study different or more frequent from the items and services ordered by the physician as part of the current standard of care? If yes, will study sponsor provide these? 2. As a result of the study or changes in patient care due to the study, will the facility experience any loss of profits for items or services that are either purchased or provided by FMS outside of a study, that are submitted to patients payors for reimbursement? If yes, the study sponsor must reimburse the facility for any such lost profits. 3. Does the study require the use of facility staff for study related administrative or clinical services above and beyond, or outside, the normal day to day responsibilities of patient care and documentation during scheduled work hours? If yes, there must be a written agreement to compensate the facility for this work. 4. Will the Investigator be hiring a member of the facility staff to perform study-related duties outside regularly scheduled work hours? 5. Other than staff-related costs addressed above, will the facility incur any direct costs related to its participation in the study? If yes, the study sponsor must reimburse the facility for any such costs. FMS Sign-Off * To be Completed by RVP * If yes was answered to any questions above FMS staff must certify to the following: Facility has adequate staff resources to provide services required by study without negatively impacting facility operations. RVP: Area Manager: Services to be provided by the facility are accurately documented in a written agreement and compensated at fair market value. The agreement has been reviewed and approved by FMS Law Department and is attached. If applicable, please see Billing and Cost Report Control Procedures, Attachment 1 and follow instructions on implementation procedures. Clinic Manager: FMS Law Department: Page 3 of 6
4 Protocol: Submitted by: Investigator Date: Return form to: Facility Medical Director Approval: Print Name: Facility Name or #: Corporate Study Coordinator Clinical Studies Department 920 Winter Street Waltham, MA Clinical Approvals: Vice President of Clinical Research For Internal Use Only Date: Legal Department Approval: Return form to Corporate Study Coordinator Date: Business Approval: Regional Vice President: Date: Compliance Department Approvals: Date: Return form to Corporate Study Coordinator Send Completed form to: Corporate Study Coordinator Clinical Studies Department 920 Winter Street Waltham, MA If the application is submitted by the Clinical Studies Department, then the Compliance Department must give approval Page 4 of 6
5 Compliance Policy C-FMS Attachment 1 Billing and Cost Report Control Procedures for Clinical Studies The following system-wide procedures have been put in place for FMS to prevent inappropriate billing and cost reporting related to clinical studies: 1.) Facility staff will follow guidelines provided by the Department of Clinical Studies on what may be entered into Proton and Ami. 2.) Accounts have been established to track the following for cost report purposes: a. Clinical Research Revenue Tools have been developed to assist in tracking costs associated with this account. Upon the approval of a clinical study, the following must be implemented at each facility that will participate in the study: 1. The Clinical Studies Department will prepare for every approved study a summary of study procedures that have the potential to impact either billing or facility cost reporting. The summary shall include all items and services that will be provided as part of the study and that may or may not be billed and any customized tools for use by facility staff to track items that may have potential cost report impacts. 2. The study coordinator must provide an in-service to each facility staff member who may be called in any way to participate in study procedures. The in-service shall include a review of the study summary and procedures for documenting study related items and services. The study coordinator will document the in-service to the Clinical Manager for the facility file. In most cases study related items and services provided are not entered into Proton and AMi. If approval has been given to enter study related items and services into Proton or AMi, instructions to use the appropriate code in supply by field must be given. Page 5 of 6
6 Compliance Policy C-FMS Attachment 2 FMCNA Authorization for Use and Disclosure of Protected Health Information for Purposes other than Treatment, Payment and Other Health Care Operations The Health Insurance Portability and Accountability Act, HIPAA, creates additional rights and responsibilities for patients and health care providers. As a requirement of HIPAA, any use or disclosure of protected health information for purposes other than treatment, payment or other health care operations requires authorization. I hereby give my authorization to (FMCNA) and its affiliated companies to use and disclose my protected health information (PHI) as described below. I understand that this authorization is valid only for the use(s) and disclosure(s) specifically described in this agreement and other use and disclosure of my protected health information will require a separate authorization. I also understand that my refusal to sign this form and authorize the use or disclosure of PHI as described below is not a condition to receive treatment from FMCNA. However, I understand that if I do not sign this form FMCNA will not be able to use or disclose the PHI. I understand I have the right to revoke this authorization in writing, except to the extent that FMCNA has already taken action in reliance thereon. For instructions on how to revoke an authorization, please call the FMCNA Privacy Office at HIPAA-01. I am aware that information that is disclosed as a result of this authorization may be subject to re-disclosure by the recipient and may no longer be protected by HIPAA. Information to be used or disclosed includes the following: Information that may be collected include your initials, date of birth, your medical history including your medical conditions, any hospitalizations and for what reason (s), your medications, your vital signs, and you laboratory results. If you choose to disclose your medical insurance and employment status verbally during an interview during the study. The information will be used by and or disclosed to the following: Authorized representatives of the sponsor This authorization will expire: Five years from the date of signature or at termination of the study for whatever reason, whichever comes first. Signature Date Print Name Facility If signed by Representative, indicate Authority to act for Individual: Distribution: Patient, Recipient(s) of PHI, Medical Record Page 6 of 6
HIPAA & Research Overview for the Privacy Board March 22, UAMS HIPAA Office Vera M. Chenault, JD
HIPAA & Research Overview for the Privacy Board March 22, 2011 UAMS HIPAA Office Vera M. Chenault, JD The Privacy Board - YOU HIPAA Privacy Rule establishes the requirements for membership and role of
More informationThe Queen s Medical Center HIPAA Training Packet for Researchers
The Queen s Medical Center HIPAA Training Packet for Researchers 1 The Queen s Medical Center HIPAA Training Packet for Researchers Table of Contents Overview of HIPAA and Research 3 Penalties for violations
More informationLifeBridge Health HIPAA Policy 4. Uses of Protected Health Information for Research
LifeBridge Health HIPAA Policy 4 Uses of Protected Health Information for Research This Policy contains the following Sections: I. Policy II. III. IV. Definitions Applicability Procedures A. Individual
More information[Enter Organization Logo] CONSENT TO DISCLOSE HEALTH INFORMATION UNDER MINNESOTA LAW. Policy Number: [Enter] Effective Date: [Enter]
CONSENT TO DISCLOSE HEALTH INFORMATION UNDER MINNESOTA LAW I. Policy: Policy Number: [Enter] Effective Date: [Enter] A. Purpose This policy establishes consent requirements for the disclosure of health
More informationPrivacy Board Standard Operating Procedures
Privacy Board Standard Operating Procedures Page 1 of 12 I. Background The Health Insurance Portability and Accountability Act ( HIPAA ) generally requires specific compliance reviews and documentation
More informationNavigating HIPAA Regulations. Michelle C. Stickler, DEd Director, Research Subjects Protections
Navigating HIPAA Regulations Michelle C. Stickler, DEd Director, Research Subjects Protections mcstickler@vcu.edu 828-0131 Key Definitions Covered Entity: Organization that handles identifiable health
More informationSUNY DOWNSTATE MEDICAL CENTER POLICY AND PROCEDURE
SUNY DOWNSTATE MEDICAL CENTER POLICY AND PROCEDURE No: HIPAA- 37 Subject: Privacy of Psychotherapy Notes Page 1 of 4 Prepared by: Shoshana Milstein Original Issue Date: 01/2017 Reviewed by: Renee Poncet
More informationPATIENT INFORMATION. In Case of Emergency Notification
PATIENT INFORMATION Patient Name Date Nickname DOB Age Sex Race/Ethnicity Language(s) spoken at home Person completing form Relation to Patient Patient Address City State Zip Phone # Other Phone Medical
More informationNAME SS# ADDRESS CITY STATE ZIP. TELEPHONE (home) (business) Cell SEX M F BIRTH DATE PLACE OFBIRTH RACE ETHNICITY LANGUAGE
REGISTRATION (please print) PATIENT INFORMATION DATE: NAME SS# ADDRESS CITY STATE ZIP TELEPHONE (home) (business) Cell Email SEX M F BIRTH DATE PLACE OFBIRTH RACE ETHNICITY LANGUAGE MOTHER'S FIRST NAME
More information******************************************************************** Policy Expectation:
HIPAA Privacy Procedure #8 Effective Date: April 14, 2003 Reviewed Date: February, 2011 Use or Disclosure of Protected Health Revised Date: February, 2011 Information on Fundraising Scope: Radiation Oncology
More informationConsent Form Requirements for Multicenter studies when CHOP Relies on an external IRB
Consent Form Requirements for Multicenter studies when CHOP Relies on an external IRB When the CHOP relies on an external IRB, that IRB (Reviewing IRB) is responsible for the review and approval the overall
More informationYALE UNIVERSITY THE RESEARCHERS GUIDE TO HIPAA. Health Insurance Portability and Accountability Act of 1996
YALE UNIVERSITY THE RESEARCHERS GUIDE TO HIPAA Health Insurance Portability and Accountability Act of 1996 Handbook Table of Contents I. Introduction What is HIPAA? What is PHI? What is a Covered Entity
More informationHIPAA Privacy Regulations Governing Research
HIPAA Privacy Regulations Governing Research HIPAA Health Insurance Portability and Accountability Act In a Nutshell The Privacy Regulations govern a provider s use and disclosure of health information
More informationHIPAA COMPLIANCE APPLICATION
1 HIPAA COMPLIANCE APPLICATION PROJECT TITLE: PRINCIPAL INVESTIGATOR Name (Last, First): Please complete this form if you intend to use/disclose protected health information (PHI) in your research. An
More informationWelcome to Baptist Medical Group - Westside. Please read the below information carefully to prepare for your upcoming appointment.
BAPTISTMEDICALGROUP.ORG Westside Welcome to - Westside Please read the below information carefully to prepare for your upcoming appointment. Please arrive 15 minutes prior to your regularly scheduled appointment
More informationPfizer Patient Assistance Program: Instructions for Group D Enrollment Form
Pfizer Patient Assistance Program: Instructions for Group D Enrollment Form This enrollment form is for patients who would like to apply to receive Lyrica (pregabalin) or Lyrica CR (pregabalin) extended
More informationCCSS: HIPAA-Compliant Recruitment. Dennis Deapen, DrPH CCSS Annual Investigators Meeting Memphis, TN October 9-11, 2005
CCSS: HIPAA-Compliant Recruitment Dennis Deapen, DrPH CCSS Annual Investigators Meeting Memphis, TN October 9-11, 2005 CCSS Institution Business Associate IRB & HIPAA approval Hire, train, supervise staff
More informationINSTITUTIONAL REVIEW BOARD Investigator Guidance Series HIPAA PRIVACY RULE & AUTHORIZATION THE UNIVERSITY OF UTAH. Definitions.
HIPAA PRIVACY RULE & AUTHORIZATION Definitions Breach. The term breach means the unauthorized acquisition, access, use, or disclosure of protected health information which compromises the security or privacy
More informationStudy Management PP STANDARD OPERATING PROCEDURE FOR Safeguarding Protected Health Information
PP-501.00 SOP For Safeguarding Protected Health Information Effective date of version: 01 April 2012 Study Management PP 501.00 STANDARD OPERATING PROCEDURE FOR Safeguarding Protected Health Information
More informationUse And Disclosure Of Protected Health Information (PHI) For Research
Current Status: Pending PolicyStat ID: 2558954 Origination: Last Approved: Last Revised: Next Review: Owner: Policy Area: References: Applicability: N/A N/A N/A 1 year after approval PAIGE ENGLISH: ASSOCIATE
More information12057 Jefferson Blvd LA, CA (323)
Playa Vista Mental Health General Adult and Women s Psychiatry 12057 Jefferson Blvd LA, CA 90230 (323) 813-6218 Please read and complete each of the sections listed below as completely as possible. NEW
More informationNew HIPAA Privacy Regulations Governing Research. Karen Blackwell, MS Director, HIPAA Compliance
New HIPAA Privacy Regulations Governing Research Karen Blackwell, MS Director, HIPAA Compliance kblackwe@kumc.edu 913-588 588-0942 HIPAA Health Insurance Portability and Accountability Act In a Nutshell
More informationWritten Financial Policy
2316 South Mason Road Katy, TX 77450 Written Financial Policy Thank you for choosing Cinco Ranch Dental. Our primary mission is to deliver the best and most comprehensive dental care available. An important
More informationOutpatient Wellness Clinic
Outpatient Wellness Clinic Patient Name: Date of Birth: Address: Phone: Email: Emergency Contact: Relationship: Phone: What is the reason for the appointment? Who were you referred by? (Physician, agency/
More informationInvestigator s Disclosure of Economic Interests Addendum
Investigator s Disclosure of Economic Interests Addendum PLEASE TE THAT ONLY TYPED FORMS WILL BE ACCEPTED. Disclosing Individual: Contact Information Department: Payroll Title: Appointment (Percentage):
More informationThe Children's Clinic Patient Information Form
The Children's Clinic Patient Information Form Patient Name: Patient Demographics of Birth: Social Security #: Mother's Name: Parent Demographics Maiden Name: Address: City/Zip: Home Phone #: Alternate
More informationAffordable Concierge New Patient Registration
Affordable Concierge New Patient Registration Patient Information Last name: First name: MI: DOB: [ ] Male [ ] Female Home address: City: State: Zip: Billing address: [ ] Same as home City: State: Zip:
More informationLou Eckart, Ph.D. and Associates Licensed Clinical Psychologists 22 Mill St. Suite 305 Arlington, MA
Lou Eckart, Ph.D. and Associates Licensed Clinical Psychologists 22 Mill St. Suite 305 Arlington, MA 02476 781-646-6306 Lou@Eckart-PhD.com PSYCHOLOGIST - PATIENT SERVICES AGREEMENT Welcome to our practice.
More informationSouthwest Medical Thermal Imaging & Ultrasound, LLC. Informed Consent for Thermal Imaging. Patient Name: DOB:
Southwest Medical Thermal Imaging & Ultrasound, LLC Informed Consent for Thermal Imaging Patient Name: DOB: You or your physician have requested that we perform a Thermal Imaging scan to obtain additional
More informationIRB 101. Rachel Langhofer Joan Rankin Shapiro Research Administration UA College of Medicine - Phoenix
IRB 101 Rachel Langhofer Joan Rankin Shapiro Research Administration UA College of Medicine - Phoenix Contents Brief discussion of regulations IRB Structure Levels of Approval Informed Consent HIPAA/HITECH
More information- Cardiac Catherization - Cardiac Angioplasty - Cardiac Bypass - MUGA - CT Scan
Thank you for making an appointment with our office. We look forward to meeting you. Please help us to prepare for your appointment by gathering the information we will need to make the most of your time
More informationCINCINNATI CHILDREN S HOSPITAL MEDICAL CENTER CONSENT TO PARTICIPATE IN A RESEARCH STUDY
CINCINNATI CHILDREN S HOSPITAL MEDICAL CENTER CONSENT TO PARTICIPATE IN A RESEARCH STUDY STUDY TITLE: The International Diffuse Intrinsic Pontine Glioma (DIPG) Registry and Repository SPONSOR NAME: Maryam
More informationPatient Registration Form
Padma Sripada MD, Columbia Internal Medicine 2500 Pond View, Suite 202 Castleton on Hudson, NY 12033 Phone: 518-391-2889 Date: Patient Registration Form First Name Middle Last Name... Sex: M F Preferred
More informationPfizer Patient Assistance Program
Pfizer Patient Assistance Program Application for Patients This application form is for patients who would like to apply to receive INFLECTRA (infliximab-dyyb) for Injection, NIVESTYM (filgrastim-aafi)
More informationDURABLE POWER OF ATTORNEY FOR HEALTH CARE DECISIONS (Medical Power of Attorney) I,, born, designate
DURABLE POWER OF ATTORNEY FOR HEALTH CARE DECISIONS (Medical Power of Attorney) I,, born, designate (Type or Print) Name of Agent, Street Address, City, State, Zip Code and Phone Number. as my attorney
More informationSection 11. Recruitment of Study Subjects (Revised 7/1/10)
Section 11 Recruitment of Study Subjects (Revised 7/1/10) The IRB shall review and approve, prior to utilization, all documents and activities that affect the rights and welfare of research subjects, including
More informationAddress: Phone: Alternate Agent: ADVANCED HEALTH-CARE DIRECTIVE. You have the right to give instructions about your own health care.
Prepared by: Grantor: Agents: Alternate Agent: Name: Name: Address: Phone: Name: Address: Phone: ADVANCED HEALTH-CARE DIRECTIVE You have the right to give instructions about your own health care. You also
More informationTHE JOURNEY FROM PHI TO RHI: USING CLINICAL DATA IN RESEARCH
THE JOURNEY FROM PHI TO RHI: USING CLINICAL DATA IN RESEARCH Helenemarie Blake, Esq. Chief Privacy Officer, Interim Office of HIPAA & Privacy Security August 2016 SCENARIO You are putting a study together
More informationIdaho: Advance Directive
Idaho: Advance Directive NOTE: This form is being provided to you as a public service. The attached forms are provided as is and are not the substitute for the advice of an attorney. By providing these
More informationPATIENT REGISTRATION FORM PARENTAL MEDICAL CONSENT FORM FOR A MINOR CHILD
PATIENT REGISTRATION FORM PARENTAL MEDICAL CONSENT FORM FOR A MINOR CHILD General Consent for Treatment I have the legal right to consent to medical and surgical treatment because (a) I am the patient
More informationAdvanced HIPAA Communications and University Relations
Advanced HIPAA Communications and University Relations accepts no liability of any use reliance placed on it, as it is warranty, express, or implied, or completeness of 1 the HIPAA Health Insurance Portability
More informationPatient: Gender: Male Female. Mailing Address: Ethnicity: Not Hispanic or Latin Hispanic/Latin Home Phone #:
5002 Highway 39 N Bldg. A Meridian, MS 39301 Phone: 601-512-0500 Fax: 601-512-0505 Patient Information Patient: Gender: Male Female First Middle Last Primary Language: English Spanish Other Mailing Address:
More informationSignature (Patient or Legal Guardian): Date:
X-Ray Patient Information: [ ] Male [ ] Female Patient Name: Date of Birth: / / SS#: Mailing Address: City: State: Zip: Phone # s: (Home) (Work) (Cell) Referring Physician: Phone #: /Fax#: Additional Physician:
More informationThe HIPAA privacy rule and long-term care : a quick guide for researchers
Scripps Gerontology Center Scripps Gerontology Center Publications Miami University Year 2005 The HIPAA privacy rule and long-term care : a quick guide for researchers Jane Straker Patricia Faust Miami
More informationRESEARCH CONFLICT OF INTEREST. Vyju Ram, MD Conflict of Interest Program
RESEARCH CONFLICT OF INTEREST Vyju Ram, MD Conflict of Interest Program Research Conflict of Interest (RCOI) Policy Federal policy (42 CFR Part 50, Subpart F)- purpose is to promote objectivity in research
More informationPatient Instructions to Obtain Copies of Medical Records
Patient Instructions to Obtain Copies of Medical Records Thank you for allowing Ventura Orthopedics (VO) the opportunity to be your healthcare provider. Please review the following guidelines and instructions
More informationUniversity of Wisconsin-Madison Policy and Procedure
Page 1 of 9 I. Policy The HIPAA Privacy Rule does not require that patients provide written or verbal authorization prior to some uses or disclosures of their protected health information. UW- Madison
More informationPatient Section. Patient Name: (Last) (First) (MI) Address: City: State: Zip: Date of Birth: / / Month Day Year Home Phone: ( ) - Cell Phone: ( ) -
Lilly Cares Foundation Patient Assistance Program PO Box 13185 La Jolla, CA 92039 1-800-545-6962 Fax: (844) 431-6650 www.lillycares.com Patient Name: (Last) (First) (MI) Address: City: State: Zip: Date
More informationSUMMARY OF NOTICE OF PRIVACY PRACTICES
LAKE REGIONAL MEDICAL GROUP 54 HOSPITAL DRIVE OSAGE BEACH, MO 65065 SUMMARY OF NOTICE OF PRIVACY PRACTICES THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU
More informationETHICAL AND REGULATORY CONSIDERATIONS
CONSIDERATIONS Office for Office for Human Research Protections The Office for Office for Human Research Protections (OHRP) is an administrative subdivision within the U.S. Department of Health and Human
More informationPablo Tebas, M.D. Joseph Quinn, RN, BSN Yan Jiang, RN, BSN, MSN
Gilead Sciences, Inc. / Protocol Number GS-US-380-1489 Page 1 of 9 PARTNER PREGNANCY FOLLOW UP CONSENT FORM Sponsor / Study Title: Protocol Number: Principal Investigator: (Study Doctor) Gilead Sciences,
More informationAssociates in ear, nose, throat/ Head & Neck surgery, pllc
Associates in ear, nose, throat/ Head & Neck surgery, pllc Notice of Privacy Practices for Protected Health Information Associates in Ear, Nose & Throat (ENT) is providing this Notice to comply with the
More informationUNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM
Gilead Sciences, Inc. GS-US-248-0123, Amendment 1, 19-JUN-2012 A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with
More informationManaging Privacy Risk in Your Research and Development Enterprise. Sujata Dayal, Abbott Justin McCarthy, Pfizer
Managing Privacy Risk in Your Research and Development Enterprise Sujata Dayal, Abbott Justin McCarthy, Pfizer Why Privacy Matters Human subject data is extremely sensitive Access to data is critical to
More informationalways legally required to follow the privacy practices described in this Notice.
The ANXIETY & STRESS MANAGEMENT INSTITUTE 1640 Powers Ferry Rd, Building 9, Suite 10 0, Marietta, Georgia 30067, 770-953-0080 Health Insurance Portability and Accountability Act (HIPAA) NOTICE OF PRIVACY
More informationSenior Care Pharmacy Wichita
Senior Care Pharmacy Wichita 1402 S.RIDGE ROAD WICHITA, KS, 67209 Phone: 316-945-7455 Fax: 316-945-7457 Contact:- Carol Parsons Dear patient/responsible party, Effective immediately, each patient/responsible
More informationHIPAA in DPH. HIPAA in the Division of Public Health. February 19, February 19, 2003 Division of Public Health 1
HIPAA in the Division of Public Health February 19, 2003 February 19, 2003 Division of Public Health 1 Handouts HIPAA Definitions AG Advisory Opinion - Definition of Health Plan DPH Coverage Determination
More informationPARAGOULD DOCTORS CLINIC PRIVACY NOTICE
PARAGOULD DOCTORS CLINIC PRIVACY NOTICE Protected Health Information THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE
More informationPEDIATRIC CENTER FOR WELLNESS, P.C. CRYSTAL B. HOOD, M.D KLONDIKE RD SW SUITE 205 CONYERS, GA TELEPHONE FAX
PEDIATRIC CENTER FOR WELLNESS, P.C. CRYSTAL B. HOOD, M.D. 1506 KLONDIKE RD SW SUITE 205 CONYERS, GA 30094 678-750-4000 TELEPHONE 678-750-4005 FAX www.pcfwellness.com Dear Family, We are excited to welcome
More informationLives (circle one): in assisted living with a relative alone
Patient name: How did you hear about us? Lives (circle one): in assisted living with a relative alone Current address (include name of assisted living or independent living facility if applicable): Current
More informationRequest to Use an External IRB as an IRB of Record
This form is to be used by investigators requesting use of an external IRB. Please submit this completed form, along with the required attachments, to the MHC IRB at hrpp@mclaren.org. (Please see SOP:
More informationMobile Mammo Registration Instructions
Mobile Mammo Registration Instructions 1. Call to schedule your appointment @ 239-936-4068 2. Fill out the following forms Note: All forms must be completed even if you were a previous patient on RRC Mobile
More informationTRICARE Management Activity s Human Research Protection Program, Data Sharing Agreement Program, and the TMA Privacy Board
Human Protections Administrators Conference Fort Detrick August 29, 2012 s Human Research Protection Program, Data Sharing Agreement Program, and the TMA Privacy Board Overview (TMA) Privacy and Civil
More informationPATIENT ADVOCATE DESIGNATION FOR MENTAL HEALTH TREATMENT NOTICE TO PATIENT
PATIENT ADVOCATE DESIGNATION FOR MENTAL HEALTH TREATMENT NOTICE TO PATIENT As the Patient you are using this Patient Advocate Designation for Mental Health Treatment to grant powers to another individual
More informationPATIENT INFORMATION FORM
PATIENT INFORMATION FORM Name: E-Mail: New Patient? Previous Patient? Previous name if different: Age: Date of Birth: Social Security #: Sex: Female Male Marital Status: S M W D Home Address: City: State:
More informationHIPAA PRIVACY TRAINING
HIPAA PRIVACY TRAINING HIPAA Privacy Training Objective Present a general overview of HIPAA and define important terms Understand the purpose of HIPAA and the Privacy Rule Understand the term Protected
More informationAPPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION
FORM W/H-01 APPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION Research for which this form is appropriate generally involves only existing patient records or specimens.
More informationINFORMED CONSENT TO PARTICIPATE IN A DIABETES RESEARCH REGISTRY
INFORMED CONSENT TO PARTICIPATE IN A DIABETES RESEARCH REGISTRY PRINCIPAL INVESTIGATOR: Andrew S. Pumerantz, DO 795 E. Second Street, Suite 4 Pomona, CA 91766-2007 (909) 706-3779 CO-INVESTIGATORS: WDI
More informationHIPAA Policies and Procedures Manual
UNIVERSITY of NORTH CAROLINA at CHAPEL HILL SCHOOL of NURSING HIPAA Policies and Procedures Manual November 2015 1 Table of Contents I. INTRODUCTION... 3 A. GENERAL POLICY... 3 B. SCOPE... 3 II. DEFINITIONS...
More informationAPPLICATION FORM - CERTIFIED PERSONNEL
APPLICATION FORM - CERTIFIED PERSONNEL WARROAD PUBLIC SCHOOLS DISTRICT OFFICE 510 CEDAR AVENUE NW WARROAD, MINNESOTA 56763 (218) 386-6099 trish_gausen@warroad.k12.mn.us All applicants will be considered
More informationIt defines basic terms and lists basic principles that all LSUHSC-NO faculty, staff, residents and students must understand and follow.
Office of Compliance Programs Revised: July 18, 2017 HIPAA Privacy HIPAA Privacy Workforce Training The Health Insurance Portability & Accountability Act (HIPAA) requires that the University train all
More information(PLEASE PRINT) Sex M F Age Birthdate Single Married Widowed Separated Divorced. Business Address Business Phone Cell Phone
(PLEASE PRINT) Emma Warner, MSW, LCSW, ACSW Tulsa, OK 74105 (918) 749-6935 Personal Information Name Address Last Name First Name Initial Home Phone Soc. Sec. # City State Zip Sex M F Age Birthdate Single
More informationForm B - For those enrolled in other insurance
Form B - For those enrolled in other insurance PATIENT REGISTRATION Please print clearly so that we can process your information quickly and efficiently. Thank you! Name (First, M.I., Last) Date of Birth
More informationPATIENT INFORMATION RESPONSIBLE PARTY INFORMATION NAME: DOB: SEX: M / F SOCIAL SECURITY # RELATIONSHIP TO PATIENT: PHONE #: CELL#: EMPLOYER:
PATIENT INFORMATION NAME: DOB: SEX: MALE / FEMALE SOCIAL SECURITY #: MARITAL STATUS: ADDRESS: CITY: STATE: ZIP CODE: PHONE #: CELL#: E-MAIL: PATIENT'S EMPLOYER: OCCUPATION: WORK PHONE: WHERE IS THE BEST
More informationPatient Section All fields are required. Please print clearly and complete all information.
Lilly Cares Foundation Patient Assistance Program PO Box 13185 La Jolla, CA 92039 Phone: 1-800-545-6962 Fax: 1-844-431-6650 www.lillycares.com Patient Section All fields are required. Please print clearly
More informationDr. Kinsler & Associates, LLC Help when life hurts
Dr. Kinsler & Associates, LLC Help when life hurts PREMARITAL COUNSELING INTAKE Bride s Name: WEDDING DATE: Age: Birthdate: Birthplace: Address: City: State: Zip: Phone: Highest level of education (grade/degree):
More informationDE-IDENTIFICATION OF PROTECTED HEALTH INFORMATION (PHI)
PRIVACY 8.0 DE-IDENTIFICATION OF PROTECTED HEALTH INFORMATION (PHI) Scope: Purpose: All workforce members (employees and non-employees), including employed medical staff, management, and others who have
More informationAUTHORIZATION FOR USE OR DISCLOSURE OF PROTECTED HEALTH INFORMATION
AUTHORIZATION FOR USE OR DISCLOSURE OF PROTECTED HEALTH INFORMATION Page 1 of 5 When you complete and sign this form, health information about you will be released as you describe in the form. Please read
More informationLangston University Returning Athlete Screening Form
Langston University Returning Athlete Screening Form Name: Address: Social Security #: : Phone: Sport: DOB: M / D / Y 1. Have you had any injury since your last athletic screening here? Yes: No: If yes,
More informationSurgical Associates of Central FL, PA 1181 Orange Avenue Winter Park, FL
Surgical Associates of Central FL, PA 1181 Orange Avenue Winter Park, FL 32789 407-647-1331 Name Date Email @ Please Circle One: Ethnicity: Hispanic or Latino American/White Not Hispanic or Latino Unknown
More informationA Better You Counseling Services, LLC 1225 Johnson Ferry Road, Ste 170 Marietta GA
A Better You Counseling Services, LLC 1225 Johnson Ferry Road, Ste 170 Marietta GA 30068 404-216-1135 Health Insurance Portability and Accountability Act (HIPAA) NOTICE OF PRIVACY PRACTICES I. COMMITMENT
More informationSystem-wide Policy: Use and Disclosure of Protected Health Information for Research
System-wide Policy: Use and Disclosure of Protected Health Information for Research Origination Date: May 2016 Next Review Date: May 2019 Effective Date: May 2016 Reference #: SYS ADMIN-RA-005 Approval
More informationModule: Research and HIPAA Privacy Protections ( )
Module: Research and HIPAA Privacy Protections (7-18-11) HIPAA's protections focus on individually identifiable health information HIPAA defines identifiable health information as (1) any form or medium"
More informationSAMPLE CARE COORDINATION AGREEMENT
SAMPLE CARE COORDINATION AGREEMENT This sample Care Coordination Agreement is between a fictional Certified Community Behavioral Health Clinic (CCBHC), Behavioral Health Clinic, and a fictional hospital,
More informationPATIENT'S NAME DATE OF BIRTH SOCIAL SECURITY # HOME PHONE # CELL PHONE # WORK PHONE #
PATIENT INFORMATION PATIENT'S NAME DATE OF BIRTH SOCIAL SECURITY # STREET ADDRESS CITY, STATE, ZIP HOME PHONE # CELL PHONE # WORK PHONE # Emergency Contact & relationship: Phone #: Pharmacies local and
More informationWHAT IS AN IRB? WHAT IS AN IRB? 3/25/2015. Presentation Outline
Education &Training WHAT IS AN IRB? Introduction to the UofL Institutional Review Boards & Human Subjects Protection Program IRB Review Process Post Approval Monitoring March 2015 1 Presentation Outline
More informationINFORMED CONSENT DOCUMENT. Project Title: The Contraceptive Choice Center: an innovative health services delivery and payment model
INFORMED CONSENT DOCUMENT Project Title: The Contraceptive Choice Center: an innovative health services delivery and payment model Principal Investigator: Research Team Contact: Tessa Madden Linda Buchanan
More informationREQUEST TO ACCESS EXISTING MEDICAL RECORDS, CHARTS OR DATABASES FOR RESEARCH
Steering Committee approved 10/17/11 1. POLICY The Aurora IRB, acting as the HIPAA Privacy Board, is required to review any request for access to medical records, charts or databases maintained by any
More informationWELCOME. Payment will be expected at the time of service. Please remember our 24 hour cancellation notice.
WELCOME Those of us at Crossroads Counseling want to thank you for choosing to work with us and we want to make your time with us as productive as possible. In order to expedite the intake process, please
More informationUniversity of Kansas Medical Center StrokeJTlA Database Project Informed Consent
KUMC Stroke rna Database Consent Form University of Kansas Medical Center StrokeJTlA Database Project Informed Consent INTRODUCTION As a person who has experienced a stroke or "mini-stroke" (a transient
More informationRoles & Responsibilities of Investigator & IRB
Roles & Responsibilities of Investigator & IRB Jaranit Kaewkungwal Mahidol University Regulatory & Guidelines Regulatory & Guidelines GCP & Computer / Database Management Systems International Conference
More informationSan Francisco Department of Public Health Policy Title: HIPAA Compliance Privacy and the Conduct of Research Page 1 of 10
Page 1 of 10 TITLE: HIPAA COMPLIANCE: PRIVACY AND THE CONDUCT OF RESEARCH POLICY It is the policy of the San Francisco Department of Public Health (DPH) to maintain the privacy of Protected Health Information
More informationThis notice describes Florida Hospital DeLand s practices and that of: All departments and units of Florida Hospital DeLand.
MRN: FIN: FLORIDA HOSPITAL DELAND HIPAA NOTICE OF PRIVACY PRACTICES Effective Date: September 23, 2013 THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN
More informationThe HIPAA Privacy Rule and Research: An Overview
The HIPAA Privacy Rule and Research: An Overview Joy Pritts, JD Research Associate Professor Health Policy Institute Georgetown University jlp@georgetown.edu 1 Topics HIPAA Background Overview of Privacy
More informationInstructions for Completion of Medical Variance Requests
ALEXANDRA ROBINSON Executive Director 44-36 Vernon Boulevard, Long Island City, NY 11101 Telephone: (718) 392-8855 Instructions for Completion of Medical Variance Requests The application for an exception
More informationHouston Rheumatology Center Sabeen Najam, MD, PA Board Certified in Rheumatology
Houston Rheumatology Center Sabeen Najam, MD, PA Board Certified in Rheumatology Patient Health Questionnaire Patient s Name: Date of Birth: Drug / Food Allergies: Please list any and all allergies you
More informationHouston Rheumatology Center Sabeen Najam, MD, PA Board Certified in Rheumatology
Houston Rheumatology Center Sabeen Najam, MD, PA Board Certified in Rheumatology Patient Health Questionnaire Patient s Name: Date of Birth: Drug / Food Allergies: Please list any and all allergies you
More informationInformation Sharing and HIPAA Compliance
Information Sharing and HIPAA Compliance The Health Insurance Portability and Accountability Act (HIPAA) became a federal law in 1996 and it is administered by the Department of Health and Human Services
More informationMAIN STREET MEDICAL NEW PATIENT QUESTIONNAIRE
NEW PATIENT QUESTIONNAIRE Patient Name: Date: Date of Birth: SSN: Male Female Guarantor Name: SSN: DOB: Home Phone: Cell Phone: Street Address: Apt#: City: State: Zip: Billing Address (if different): Email
More informationSchool Based Oral Health Services
Seal a Smile Oral Health Program A project of Whitney M. Young Jr. Health Services and the Healthy Capital District Initiative School Based Oral Health Services Oral health classroom education Dental screenings
More information