Federal Tort Claim Act Medical Malpractice Program CY 2014 Application Technical Assistance February 28, 2013 Christopher Gibbs, JD, MPH Sharon Zang, PhD, RN, LPC Amelia Broussard, PhD, RN, MPH Office of Quality and Data Health Resources and Services Administration

Review of Risk Management Risk Management is comprehensive of the entire organization. Risk Management is Board driven and Board overseen. Clinical risk management includes: –Annual risk assessment –Clinical protocols –Peer reviews –Supervision of health center staff: clinical and nonclinical –Medical records policies –Triage policies (walk-in and phone) –No show appointment policies –Tracking policies: referrals, hospitalizations and diagnostic testing 2

Main Points for QI/QA Plan should include: –Statement of purpose –Scope of plan –Administrative responsibility –Risk management systems –Committee membership –Committee accountability –Activities; tracking –Approval; review QI and Board meeting minutes should: –Include specific data about ongoing QI projects –Report performance on selected measures from QI plan –Progress on goals for QI program 3

Questions from Day One 4

Section Three: Credentialing and Privileging 5

Definitions Credentialing: The process of assessing and confirming the qualifications of a licensed or certified healthcare practitioner to render specific health care service(s). Privileging: The process of granting the qualified health care provider (Licensed independent practitioners ) the permissions to render specific health care services and perform specific health care procedures for a limited time (2 years). 6

Importance of Credentialing and Privileging Ensures all health care providers (LIP’s) and clinical staff (licensed and certified) are qualified to render the type of care for which they are employed. Involves evaluating a practitioner’s eligibility to provide clinical services at the health center and evaluating the provider’s competency for specific clinical privileges. Failure to fully credential may result in liability if a patient is harmed. 7

Will accreditation fulfill FTCA requirements ? While there are commonalities between accrediting bodies and FTCA there are also differences and FTCA requirements that must be met. Health centers need to crosswalk between: –FTCA credentialing and privileging requirements –Their accrediting body’s credentialing and privileging requirements –The 330 program expectations –State requirements –Third party reimbursement requirements 8

Question # 1 1.All current health care personnel involved in direct patient care must be credentialed within the last two years in accordance with the requirements outlined in PIN and PIN , Including all of the following: –Licensed independent practitioners (Physicians, nurse midwives, nurse practitioners) –Licensed practitioners (e.g. RN’s, LPN’s, dental hygienist) –Certified practitioners/technicians (e.g. dental, lab, radiology, CNA) o Credentialing must be completed prior to individual providing patient services 9

Licensed or Certified Healthcare Practitioners Organization's policies need to clearly define: Licensed or certified healthcare practitioner: an individual required to be licensed, registered, or certified by the state, commonwealth, or territory in which a health center is located. –Licensed independent practitioner (LIP): Providers permitted by law and the organization to provide care and services without direction or supervision, within the scope of the individual’s license and consistent with individually granted privileges (e.g., physician, nurse practitioner, physician assistant, dentist, nurse midwife, behavioral health). –Other licensed or certified practitioner: Providers not permitted by law to provide patient care without direction or supervision (e.g., laboratory technician, social worker, laboratory, X-ray, medical assistant, registered nurse, licensed practical nurse, dental hygienist). 10

Attachment E Attachment E: upload the credentialing list (excel spread sheet). 11

Credentialing Spreadsheet Questions and Answers Q: Who should appear on the credentialing list? A: All health center practitioners, employed or contracted, volunteers, and locum tenens (i.e., temporary practitioners), at all health center sites should appear on the credentialing list. Licensed independent practitioner (LIP) Other licensed or certified practitioner Q: Should employees from the past year or current employees appear on the credentialing list? A: No, only individuals who are currently working at the health center at the time of submission of the application. 12

Attachment F1 and F2 Attachment F1: Up load the health center’s Credentialing and Privileging policy. The Policy must be board approved. –Indicated with date and signature of Board member. Attachment F2: If submitting Board minutes as proof that the credentialing and privileging policy was approved, please upload minutes that have been signed, dated and clearly indicate that the Board approved the Credentialing and Privileging policy. 13

Credentialing Plan Expectations of credentialing plan: –It speaks to the duty to care for patients and the duty to prevent harm to patients. –The plan provides a step by step guide to ensure the credentialing processes is completed. –A credentialing plan ensures staff are performing health care services within their education, training and licensure and/or certification. –It provides a clear pathway for organizations to hire and/or dismiss clinical staff. 14

Credentialing Plan Examples of what should be in credentialing plan –Consistent with PIN (recommend referencing to PIN) –Describes a credentialing and privileging procedure for both LIPs and Other Licensed and Certified Practitioners –Describes when primary and secondary sources are used –Requires re-credentialing every 2 years for all practitioners –Describes process for Board of Directors to approve credentialing files (or specifically delegate approval authority) –Board Approved and signed within past 3 years 15

Question # 2 2.The health center’s credentialing verification procedures include all of the following: –Current licensure, professional certification, and/or registration that is primary source verified. –Professional educational background/postgraduate training o Primary source verification for licensed independent practitioners o Secondary source verification for other licensed and certified practitioners 16

Primary vs. Secondary Source Verification Primary source verification: verification by the original source of a specific credential to determine the accuracy of a qualification reported by a practitioner. –Direct correspondence –Telephone/Internet verification –Reports from credentials verification organizations –The Education Commission for Foreign Medical Graduates, American Board of Medical Specialists, American Osteopathic Association Physician Database, American Medical Association Master file may be used to verify education and training *Source: HRSA PIN

Primary vs. Secondary Source Verification Secondary source verification: verification by sources other than primary sources. –Original/initial credential –Notarized copy of credential –Copy of credential (when copy is made from an original by approved health center staff) Source: HRSA PIN

Primary and Secondary Verification for LIPs Primary source verification for LIPs is obtained for the following: –Applicant’s license –Applicant’s education, training, experience –Applicant’s registration –Application’s certifications –Applicant’s current competence –Applicant’s ability to perform services for which privileges are requested Secondary source verification for LIPs is obtained for the following: –Government-issued photo ID –DEA registration (if applicable) –Hospital admitting privileges (if applicable) –Immunization and PPD status 19

Primary and Secondary Verification for Other Licensed/Certified Indv. Primary source verification for other providers is obtained for the following: –Applicant’s license Secondary source verification for other providers is obtained for the following: –Applicant’s education, training, experience –Applicant’s registration and certifications –Applicant’s current competence –Applicant’s ability to perform services for which privileges are requested –Government-issued photo ID –DEA registration (if applicable) –Hospital admitting privileges (if applicable) –Immunization and PPD status 20

Question # 3 3.The Health center has verified that each practitioner submitted evidence of the following for review: –Health fitness/fitness to perform duties –Immunization status –Professional references –Life support training, as applicable –DEA registration, as applicable 21

Verification of Required Information It is helpful to use a checklist to ensure all required information is collected by the health center or received from the provider: Curriculum vitae (CV) Diplomas (e.g., undergraduate, post-graduate, medical school, residency, fellowship) Statement confirming health fitness Certificates (e.g., board certification, BLS, ACLS) Medical licenses Drug Enforcement Administration (DEA) registration (if applicable) Controlled Dangerous Substances (CDS) registration (if applicable) Peer references 22

Verification of Required Information Proof of liability insurance Summary of malpractice claims/adverse actions filed against the provider National Practitioner Data Bank (NPBD) query Delineation of privileges Government-issued picture identification Immunization and PPD status Life support training (if applicable) Fit for duty Verification of hospital and/or facilities privileges  See the Credentialing Timeline for a sample checklist:

Credentialing Check List 24

Renewal Check List 25

Credentialing Files Maintain complete and organized required credentialing documentations and records. Regularly identify expiring credentials before expiration Review each file once per year to identify any missing items. If you use a credentials verification organization (CVO): – Ensure the CVO understands FTCA requirements. –The contract with the CVO speaks to privacy, document owners, document retention. –Ensure your privacy release (signed by LIP) speaks to the use of a CVO by the organization. 26

Question # 4 4.A national Practitioner Data Bank (NPDB) query is obtained and evaluated every two years for each licensed practitioner as part of the health center’s credentialing process. –All licensed personnel need to be queried within the NPDB. Please see: NPDB customer Service Center:

Question # 5 5.A history of previous malpractice liability claims and adverse actions (including but not limited to FTCA claims) is reviewed for each practitioner and for the organization. –Any malpractice claims in which the provider is named must be explored. –Any adverse actions such as licensure Boards complaints or actions; limiting/denial of facilities privileges, etc. need to be explored. –Policies and processes must be in place to review the credentials of an applicant and/or employee and accompanying methods for determination if the credentials meet health center need, qualifications, and requirements. –Provide a statement that includes date of alleged incident, clinician’s name and specialty, and brief summary of allegation. Do not include case details, admissions, patient names, etc. –State how/if claims were internally analyzed and if a response was implemented in response to any liability claims or allegations as needed. 28

Question # 6 6.The health center utilizes data from peer review and quality improvement/quality assurance activities to support its credentialing functions and these activities are overseen by the board. *Refer to Peer Review Policy 29

Questions # 7, and # 8 7.As part of the health center’s privileging process, practitioners are granted privileges by the health center, at least every two years, specific to services being provided at each delivery site. 8.As part of the health center’s privileging process, clinical privileges and medical staff membership at local hospitals and other admitting facilities are verified. 30

Privileges Each practitioner should be privileged specific to the services prior to rendering services. Privileging processes verifies clinical privileges and medical staff membership at local facilities Renewal or revisions of privileges for LIPs and other licensed or certified practitioners must occur at least every two years. Full and temporary privileges need to be clearly defined (time limited with only specific reasons for temporary). Providers must be privileged prior to rendering health care services. 31

Privileging Approved applicants are notified in writing within a defined timeframe. Approved applications and a copy of the approval letter are forwarded to appropriate internal personnel within a defined timeframe. Applications whose requests are denied are notified within a defined timeframe. The health center has a defined policy for making changes to final approved/denied applications. 32

Question # 9 9.The integration of quality improvement/quality assurance and risk management facilitates the identification of potential problems and prevention of adverse occurrences. Prevention diminishes the potential for process failures. The quality and risk management process promotes a safer environment and empowers to be efficient quality care providers. This process must be conducted on a consistent and ongoing basis throughout the year. a.Describe the health center’s peer review process and the frequency with which it is conducted. b.Who supervises this process and what are his or her responsibilities? 33

Question # 9 c.How is feedback on peer review communicated and documented? d.How is patient confidentiality maintained during the medical record review process? e.After completing peer assessment and medical record review, how is data integrated and shared with staff and the board? f.What methodology is used when developing strategies for improvement? 34

Peer Review Policy The goal of medical peer review is to deliver standard of care and to improve the quality of care and patient safety by learning from past performance, errors, and near misses. Connect peer review to credentialing and privileging. Policies should address: –Who supervises the process and his/her responsibilities –Frequency of reviews and number of charts per provider –How feedback is communicated and documented –How patient confidentiality is maintained –How data is integrated and shared with the board –What methodology is used when developing strategies for improvement. 35

Ways to ensure compliance with FTCA requirements. Fully understand the FTCA requirements. Cross check the health center’s scope (5A, 5B and 5C) is updated and consistent with privileges being granted. As seen in organizational documents the Board oversees Risk Management, QA/QI and Credentialing and Privileging. The health center’s credentialing and privileging policies must be approved by the governing Board of Directors. Credentialing and privileging procedures must be completed and documented. The credentialing processes and delineation of privileges was must be completed, and reviewed by the CMO and a committee. –The reviewing committee must document the review of specific providers credentialing application. –The Board must approve privileges. Or alternatively formally delegate to a and organizational committee AND be ensured the organization is compliant. –The Board must document privileges were approved. 36

Ways to ensure compliance with FTCA requirements Medical staff can not provide health care prior to completion of credentialing process and/or privileging processes. Risk management/corporate/QA/QI programs should audit the credentialing and privileging processes to ensure policies and procedures were fully implemented and the organization was compliant. 37

Credentialing Questions 38

Section Four: Additional Information Professional Liability and Risk Management Training 39

Information Submitted Brief description of current and previous malpractice claims –Malpractice history submissions –Claims review process Recognition and Accreditation Section Risk Management Training Program 40

Professional Liability History Possible litigation requires preservation of any documents related to claim Summary of each allegation and what has been done to alleviate future occurrences filed within last five years –Name of provider(s) involved –Area of practice/specialty –Date of occurrence –Summary of allegations –Status/outcome of claim Remove personal information and conclusions of liability Refer to following website for more information  INSERT NEW PAL NUMBER HERE 41

Claims Review Process Describe process in place for reviewing malpractice claims Relate process to appropriate risk management or quality improvement committees for development of programs designed to reduce future occurrences Do not include specific information about each individual claim 42

Recognition and Accreditation Refers to accreditation received by center during last year Includes Patient Centered Medical Home recognition and The Joint Commission Recognition Does not require submission of documentation of accreditation or recognition Centers should maintain documentation in case of operational site visit in future 43

Accreditation/Recognition Resources The Joint Commission accreditation for ambulatory care: ealthcare.aspx. ealthcare.aspx Accreditation Association for Ambulatory Health Care: Adjunct Medical Home Chapter (if applicable) National Committee for Quality Assurance Patient Centered Medical Home Accreditation:  See “Resource Page: Patient-Centered Medical Home” on the Clinical Risk Management website:

Risk Management Training Description of all types of educational opportunities for medical staff and clinical support staff Describe process used to assure that medical staff and clinical support staff attend risk management training regularly Plan should be developed annually to assure that risk management training is conducted and available to providers 45

Training/Continuing Education Topics Patient safety Infection control/hand hygiene Teamwork and communication Medication safety Fall prevention Fire safety Documentation Disaster planning Obstetrics safety 46

Sources of Education/Training Bloodborne Pathogen Communication/Disclosure Hand Hygiene Risk Management/ Patient Safety Sharps Injury Prevention Cross-Contamination from Flexible Endoscopes 47

ECRI Institute’s e-Learn FTCA deemed health centers and free clinics have free access to e-Learn as part of the Clinical Risk Management Program membership Library of courses for continuing education credit In order to access e-Learn –Go to –Register using your course keys; create a username and password –After initial registration, log-in each time with your username and password 48

Clinical Risk Management Website Go to: Enter username and password under “Member Login” Don’t have a username and password? Contact us:   (610) x

Upcoming ECRI Opportunity Peer Review: An Opportunity for Improving Patient Outcomes and Quality of Care Session will provide guidance on the development and implementation of a peer review program and how it can be incorporated into the health center’s QI activities March 13 th at 12:00pm ET and/or March 14 th at 3:00pm ET All ECRI FTCA Webinars are FREE 50

Sources for Deeming/Application Process TA Contact BPHC helpline at BPHC ( ) or  9:00AM to 5:30PM (ET) FTCA website: For EHB technical support (e.g., registration, username and password), contact HRSA Call Center at or  Monday-Friday (except federal holidays) 9:00AM to 5:30PM (ET) 51

Questions for Day Two 52