Federal Tort Claim Act Medical Malpractice Program

CY 2014 Application Technical AssistanceFebruary 26, 2013

Christopher Gibbs, JD, MPHSharon Zang, PhD, RN, LPC

Amelia Broussard, PhD, RN, MPHOffice of Quality and Data

Health Resources and Services Administration

OverviewThis presentation is meant to give a general overview

of the 2014 application and highlight notable information that will be helpful while filling out this year’s application

Day One:• Application logistics• Application sections

– Risk Management – QI/QA

Day Two:• Application sections

– Credentialing/Privileging– Additional Information

• Available Resources

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Review Process

• Completeness and Accuracy (CA) Reviewer– Are you missing something?

• FTCA Reviewer –Let us look at the substance

• Program Quality Check (PQC) Reviewer– We love to review

Types of Applications

• There are two types of applications for FTCA coverage:– EHB System will be opened to receive applications on ,

2013– INITIAL DEEMING APPLICATION

o May be submitted at any time during the year when the EHB system is open to receive applications.

o Will be acted upon by HRSA within 30 days after receipt of a completed application

– ANNUAL REDEEMING APPLICATIONo All currently deemed health centers must file a

renewal deeming application to be deemed for CY 2014. This year’s deadline: TBA

Electronic Handbook Reminders

• If you have trouble logging in, please contact the HRSA helpdesk at 877-464-4772 or by email at callcenter@hrsa.gov

• Old applications in the FTCA folder• A full application must be attached for each subrecipient

seeking FTCA coverage• You must submit application for it to be reviewed• Not changeable once submitted• 10 business days to revise if sent back

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2014 Requirements

A complete initial or redeeming application must include:1. An Application Form completed in EHB2. Referral, hospitalization, and diagnostic tracking

policies and procedures3. An approved Quality Improvement/Quality Assurance

Plan, including governing board signature and approval date

1. Two Methods to demonstrate Board approval QI/QA Plan + Page with Board of Directors Signature QI/QA Plan + Signed Board Minutes showing QI/QA plan

was approve

2014 Requirements

4. Minutes from past 6 QI/QA committee minutes within the last year. Remove patient names and other identifiers

5. Minutes from any six Board meetings that reflect Board approval of QI/QA activities. Remove all information not related to QI/QA activity

6. Summary of professional liability history for cases filed or closed within the last 5 years, if applicable

Name of provider(s) involvedArea of practice/SpecialtyDate of OccurrenceSummary of allegationsStatus and outcome of claim

2014 Requirements

7. Credentialing list (in an excel spreadsheet) of all licensed and/or certified health care personnel employed and/or contracted by the health center, with the following information:o Name & Professional Designation (e.g., MD/DO, RN,

CNM, DDS)o Title/Positiono Specialtyo Employment Status (full-time employee, part-time

employee, contractor, volunteer)o Date of Hireo Current Credentialing Dateo Next Expected Credentialing Date

2014 Requirements

8. Board-approved Credentialing and Privileging (C&P) policies

Must be signed and dated by the Board (C&P) Plan + Page with Board of Directors Signature OR (C&P) Plan + Signed Board Minutes showing C&P plan was

approved9. Explanation of any “NO” responses10. Deeming applications for any sub-recipients (as

documented on the organization’s most recent approved scope from FORM 5B - see “sub-recipient submission instructions.”)

SECTION ONE:RISK MANAGEMENT

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Overview of Risk Management

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Risk Management Definition

The identification, analysis, assessment, control, and avoidance, minimization, or elimination of unacceptable risks.

The identification, assessment, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability and/or impact of unfortunate events or to maximize the realization of opportunities (Hubbard, 2009).

Hubbard, Douglas (2009). The Failure of Risk Management: Why It's Broken and How to Fix It. John Wiley & Sons. p. 46.

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Risk Management Strategies

• Proactive is looking forward, assessing the functions and activities of the organization, planning for risks inherent in the organizational system, minimizing or eliminating those risks. – An example would be a risk management plan that protects

electronic organizational and patient information by having a generator, redundancy and backed up information, etc..

• Reactive is responding in a coordinated way to unexpected occurrences in a thoughtful, logical manner that minimizes loss and risk. – An example would be responding when the server crashes and

patient records are not accessible to providers.

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Implementation

Implementation is the realization / fulfillment and execution of a policy.

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Example of an Adverse Event

• Medications errors are often the cause of Adverse Patient Events, clinical risk management policies help prevent harm to patients by ensuring these types of errors are prevented.

– An example of an adverse medication error would be a provider prescribing an in-office injectable medication such as a Depo-Provera shot and the wrong injectable, such as the flu shot was given instead. Four months later, the patient was pregnant.

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Aspects of a Risk Management Plan

• Governing Board has a commitment to safety and quality;• The plan is based on healthcare national standards and

regulatory/program requirements;• The plan is customized to fit the organization’s, sites, services, size,

and patient population; • There is a clear mission statement with goals, objectives, activities,

timelines, and defined staff responsibilities;• The plan is reviewed and updated periodically;• There is active and on-going monitoring/auditing, problem

identification, data collection, corrective actions, documentation and reporting to the committee and the Board of Directors.

• The health center engages all staff in risk management.

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Risk Management • Governance Corporate/regulatory/grant compliance organizational

policies and procedures, oversight duties are fulfilled, BOD training, BOD document retention (i.e. is the governing board fulfilling their requirements?).

• Administrative Implementation of organizational policies and procedures, ensures the processes within policies and procedures are implemented and are occurring as demonstrated through documentation, claims management, legal and contracts, insurance (e.g. property, D&O, gap, etc.), marketing /advertising/public relations, operations are regulatory/grant requirements, and is meeting goals set forth by the BOD.

• Business/Finance Policies and procedures, billing, contracts, corporate/regulatory and grant compliance, procurement of assets, internal and external auditing, reporting, document retention, internal auditing processes are occurring.

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• Environment: Buildings and grounds, equipment, materials, disaster preparation and management, safety/security, event/incident/accident reporting and investigation.

• Human resources: HR policies and procedures, compliance with employment regulatory requirements, job descriptions, employee handbooks, employment contracts, employee credentialing, employee orientation, employee health, on-going employee training and development, document security and retention.

• Information technology: Privacy and security, vendor contracts, HIPPA,HITECH, information exchanges, patient portals, disaster and recovery plans, IT system redundancy plans.

• Clinical: Credentialing of providers, quality/performance assessment and improvement, standard of care (clinical protocols), environmental and employee safety, infection control, patient tracking and follow-up, patient communications, patient and family education, patient satisfaction, pharmaceuticals and therapeutics, behavioral health and social service programs, volunteers.

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Risk Management - Continued

Examples of areas of focus for Risk Management

• Buildings and grounds • Safety and security • Equipment management • Claims management • Contracts and Procurement • Corporate/regulatory/grant compliance • Marketing/advertising/public relations • Disaster preparation and management • Event/ incident/accident reporting and investigation • Finance/ billing • Human resources compliance • Employee health • Staff training/education • Credentialing of providers • Clinical protocols • Infection control • Information technology • Patient tracking and follow-up • Patient communications • Patient and family education • Patient satisfaction • Pharmaceuticals and therapeutics • Product/materials management • Quality/performance assessment and improvement • Behavioral Health and social service programs • OB services • Pain management • Staff training/education

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Implementation and Organizational Documentation

• Within the organizational policies there are closed loop processes in place. Documentation of an active RM program:– Policies are present and approved by the governing Board of

Directors – RM processes are implemented– Board of Directors and employee training programs are present– Data is being collected– Committees are reviewing data– Potential and existing risks are being identified– Solutions are explored and applied– On-going monitoring occurs– Reports are presented to the Board for oversight and governance

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Deeming Application Questions

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Deeming Application

Review of Risk Management Systems1. The organization conducts periodic assessments to

identify, prevent and monitor medical malpractice risk.

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Clinical Risk Management Assessments

• Risk Management work plan (QA/QI)• Review of policies and procedures• Peer Review and chart audits• Scope of grant & privileging• Clinical outcome measures• Event/incident monitoring• Supervisory Agreements• Patient complaints• Adverse outcomes• Claims review

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Benefits of Peer Review

• Using peer review as a way to educate individual physicians as well as the staff in general means that it's integrated into the health center’s overall health performance goals and QA/QI processes.

• Educational peer review, for both the provider and the health center, is a tool for identifying, tracking, and resolving suboptimal or inappropriate clinical performance and medical errors in their early stages.

• This improves patient safety and overall quality of care.

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Peer Review continued

– A closed loop peer review process which evaluates if the provider is delivering quality care per organizational protocols. o There are defined processes for addressing issues identified.

Peer review processes address: who, what, where, when and how (e.g. who will review charts, how many per month, how will charts be reviewed and what will happen with reviews).

o The procedures need to clearly define what remediation actions will occur given peer review findings. For example level 1, 2, 3, 4 findings would correlate to specific responses.

o Peer reviews are retained and used for re-credentialing.– Higher risk practices such as obstetrics and pain management need

more rigorous monitoring standards and frequency.

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Deeming Question # 2

2. Identify and describe the policies/procedures that are implemented related to how PAs, NPs and support staff such as RNs, LPNs, and MAs are supervised. This description should also include whether there are supervisory agreements for PAs and collaborative agreements for NPs. – The organizational chart reflects appropriate lines of authority and

supervision.– The supervision policies are implemented regarding supervision of

staff (i.e. physicians, dentist, mid-level providers, nursing and MA,).– Policies are inclusive of support personnel, laboratory technicians;

behavioral health and social workers; registered nurses; dental hygienists; dieticians; physicians’ assistants; medical residents.

– There are well developed job descriptions with scope of practices, specific employee orientation and training, and review of competency and skill for all staff

– Policies are consistent with state law on supervisory and collaborative agreements

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Supervision of clinical and non clinical staff continued

• Personnel manual/employee handbook• Clearly defined job descriptions with definition of employee scope• Nursing Policies and Procedures• Front Desk Policies and Procedures• Administrative Policies and Procedures

*policies and procedures need review and updating as operations (e.g. sites and services) change. Employees job descriptions reviewed, training and competency skills evaluated.

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Question # 3A and 3B

3A. There are medical record policies and procedures that address the following:• Privacy (HIPAA) – YES or NO• Completeness of documentation – YES or NO• Archiving Procedures – YES or NO

3B. Medical records are periodically reviewed to determine quality, completeness, and legibility

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Medical Records

• Privacy updates as the electronic health record is updated/changed – such as going live with patient portals. Completeness of documentation, timeliness of documentation, coding of encounters.

• HIPAA - all staff must be trained and expected to maintain the privacy, confidentiality, integrity, and security of protected health information.

• Completeness of documents is inclusive of patient demographic information, income verification, current medications, allergies, current and past health conditions, patient assessments, standard of care treatments, performance measures (UDS), referrals and testing.

• Policies should define what information is included in medical records, and archiving procedures. Health centers need to check state statutes, administrative codes, or state medical boards.

• In addition to peer reviews, scheduled and on-going chart auditing needs to occur. This gives the organization the opportunity to explore the entire patient record for the above items.

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Questions # 4

4. There are policies/procedures that address the following:– Triage – YES or NO– Walk-in Patients – YES or NO– Telephone Triage – YES or NO– No Show Appointments – YES or NO

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Triage• Since health centers care for vulnerable populations with poor access

to health care, patients often arrive on-site very ill - sometimes with an appointment, sometimes without an appointment. Triage assessments are essential in delivering needed medical treatment(s) within an appropriate time frame.

• Patients calling for appointments may need phone triage to assess the acuity of their condition.

– Good triage allows a patient’s conditions to be quickly assessed in order to render timely and appropriate medical care. Delays in assessing and treating patient conditions can lead to increased symptoms, increased hospitalizations/ED visits, poor patient outcomes and increased malpractice claims.

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Triage Policy

• Triage policies include who, what, when and how to respond.

• Depending on the type of practice, (e.g. family practice, OB, pediatrics, etc.) standard of care for different patient conditions/ compliant warrants different triage responses.

• Staff roles and responsibilities are clearly identified.

• Staff are trained in their duties and responsibilities.

• Triage events are part of the QA/QI processes.

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No Show

• “No-Show” risks are:– Possible negative health consequences for patients– Liability risk – Reduced accessibility – Lost revenue

• Patients need to be informed of health center policies and procedures for missed appointments; follow-up for missed appointments should be documented in patient records and depending on the health center’s target population (e.g. homeless population), reasonable accommodations for missed appointments needs to be considered.

• Tracking and monitoring no show appointments helps the health center explore the causes (i.e. internal and external), and patient utilization patterns.

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Question # 5

5. There are clinical protocols that define appropriate treatment and diagnostic procedures for selected medical conditions.– Clinical protocols for frequent conditions (i.e. diabetes,

hypertension, pain management, prenatal care, etc.).– Protocols need to be based on standard of care for that type of

practice. – Protocols need to be updated periodically. – Providers and clinical staff need orientation and training regarding

their role of standard of care. – Clinical procedures done at the health center are clearly defined,

staff is qualified to perform the procedures.– Peer reviews are conducted based on clinical protocols.

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Question # 6

6. There is a tracking system for patients who require follow-up of referrals, hospitalization, diagnostics (i.e. x-ray, lab results)– Referral tracking – YES or NO– Hospitalization tracking – YES or NO– Diagnostic tracking ( x-ray, labs) – YES or NO

ATTACHMENT A - Please upload the health center’s clinical policies and procedures for only the items listed in question 6.

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Referral Tracking

• Does referral policy ensure referrals are: – tracked, by whom, how often and within a specific time frame– referring providers are contacted for patient information – patients are reminded of the importance of making referral and are

called to be reminded of the referral appointment– referring providers notify health center if patient ‘No shows” for the

referral – patients are contacted if they do not make their appointments – all patient referrals are documented – all calls and contacts are documented – the health center uses their EHR to assist with tracking referrals

(reports are generated daily/weekly/monthly)– Referral tracking monitoring is part of QA/QI processes

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Referral Tracking

– Is there a tracking log with patient identifier, test date, ordering provider, list of tests, reviewed results, follow-up recommendations and communications with the patient.

– Policies and documentation need to reflect a closed looped process.

• With the recent volume of organizations transitioning to an EHR, it is important to keep tracking systems intact.

• Failure of follow up systems may lead to claims associated with failure to diagnose or delay in diagnosis.

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Why is hospital tracking important?

• The over arching goal is to deliver health care services early/timely/consistently so that hospitalizations and/or ED visits are less. When a patient is hospitalized once released, the goal is to maintain and improve their health status.

• Being discharged from the hospital can be dangerous • 20% of patients experience adverse events within 3 weeks of discharge• Nearly three-quarters of which could have been prevented • Adverse drug events are the most common post discharge complication

nearly 40% of patients are discharged with pending test results and recommended further diagnostic testing

*Source: http://www.psnet.ahrq.gov/primer.aspx?primerID=11

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Hospital Tracking

• Does the hospital tracking policy ensure:– Staff members have identified roles and responsibilities including

after-hours, holiday and weekend coverage.– Staff are trained to complete these duties.– Ensure the hospital tracking log identifies patient information and

follow-up documentation.– Update health center contact information annually and if the

information changes with area hospitals.– Identify key hospital staff that will ensure notification and

documentation is forwarded to the health center.– Educate patients to identify themselves as health center patients if

hospitalized or visit the ED.– Tracking, auditing and reporting performance compared to goals.

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Strategies to Improve Tracking Hospitalizations/ ED

• If you haven’t received any hospitalization or ED notices, call the most frequented hospitals to ensure there isn’t a system failure/issue.

• Ensure patients carry health center business card.• Educate patients to contact the health center when or if they have a

hospitalization and/or visited a ED.• Ask the patient at time of all visits if they have been hospitalized or

visited a ED.• Check the fax machine (emails) frequently .• Set up an open access or blended patient appointments for same day.

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Diagnostic Testing

Why is this important? Missed or delayed diagnoses (particularly cancer diagnoses) are a prominent reason for malpractice claims.• The organization must identify normal, abnormal and critical lab values.• Health center staff must know policies and procedures for abnormal

and critical lab results and individual’s identified role. • Provider notification of all labs, needs to include EHR if appropriate.• Policies and procedures need to describe how often are labs reviewed,

what happens when the ordering provider is not on-site. • Immediate patient notification of all CRITICAL test results. In some

areas these are known as “Panic” values. • Procedures need to include after hours, weekend and holiday

responses to abnormal lab values.• Patient records need to include documentation and treatments

rendered.

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Diagnostic Testing continued

• Documentation of notification [date/time/person spoken with] and follow up recommendations including come to the health center or go to the emergency room.

• What happens if the patient can’t be reached. • DO NOT leave critical or abnormal lab results on voicemail or text or

email. Have alternative patient contact information. Verify patient information at each contact with the patient (phone and/or appointment).

• In some cases law enforcement offices can be called for “sick visit”.• The diagnostic tracking log is complete and up to date, the tracking

information is part of the patient record.

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Risk Management Questions

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SECTION TWO:Quality Improvement/

QUALITY ASSURANCE

Understanding Quality Improvement & Quality Assurance

• Quality Assurance and Quality Improvement are often confused as same process

• Terms used interchangeably but not the same• One is focused on observations only and represent a one

time opportunity• Other is continuous process documenting improvement • Both based on standards for performance• Both important to organization• Both focus on quality services to patients

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Definition of Quality Assurance

• Planned systematic activities implemented in quality system• Quality requirements for product or service fulfilled• Activities typically based on standards of practice• Can help identify problem but not solution oriented• Compliance with standards or goal

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Definition of Quality Improvement

• QI is continuous ongoing process designed to improve patient outcomes, services or process

• Focus is ongoing rather than one time review• Team is multidisciplinary with representatives from all

departments• Focus on process or service not individual• Proactive rather than reactive

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Goals of QI

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• Understand process• Reduce & eliminate errors• Improve efficiency• Improve communication• Requires measurement• Focuses on outcomes

Goals of Quality Improvement

Core Concepts of Quality Improvement

• Exceed expectations of patients or clients• Process usually problem not people• Does not seek to blame but to improve process• Most effective when part of everyday work• Focus on everything, you can not focus on anything

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• QI plan integrates all departments in activities

• One QI plan for organization

• Minutes document QI activities

• Plan should have certain components outlining process of committee

Goals of QI Plan

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Quality Improvement Plan Components

• Statement of Purpose or Intent of Plan• Scope of Plan• Administrative Responsibility• Risk Management Systems (may be separate plan)• Role of Peer Review in QI• Committee Composition• Committee Accountability• Methods for conducting QI activities• Tracking of QI Activities• Approval and Review

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Statement of Purpose

• Plan includes statement of purpose or intent• Example

– The purpose of the Quality Improvement Program is to support improved health care delivery and outcomes for the patient population receiving care. Objective is to promote continuous Quality Improvement within the organization and support the objectives and scope of Quality Improvement Program.

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Scope of Plan

• Scope refers to what QI committee will do• Includes monitoring of select measures, evaluation of

performance and improvement in organizational performance

• Discusses which activities are applicable to QI• Includes risk management tracking as reported to QI,

results of peer review and measures to be followed during year

• Areas of consideration include medical/clinical, operational/administrative, governance and finance

• Resources available in notes section

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Administrative Responsibility

• Health center identifies by title individual with overall responsibility for QI program

• Approval requirements are stated (who must approve plan)• Individual consulted in development of QI/QA Plan and

activities• Identification of who will receive information about decisions

and activities of QI/QA program

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Risk Management Systems

• Health center identifies the following:– Policies/procedures regarding appropriate supervision of

clinical and non-clinical staff– Policies/procedures to identify and document system

process or breakdown– Policies/procedures for addressing and investigating

medical malpractice claims• Resources available in Notes section of slides

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Role of Peer Review

• Peer review is process of all providers reviewing a peer’s medical records

• Specific time frame for review is defined (i.e. quarterly, monthly, bi-monthly)

• Results of peer review should be communicated in aggregate form to QI committee for possible QI projects to improve patient care

• Review should consist of two parts– Medical care review– Review for completion and documentation– Resources in Notes section

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Committee Composition

• Establishes QI committee• Membership is defined• Multidisciplinary membership• Committee chairperson & vice chair person identified• Committee must have defined meeting frequency. Meeting

6 times per year strongly encouraged*• Agendas and minutes for committee meetings maintained

* Application requires 6 sets of minutes within past year.

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QI Committee Accountability

• Short statement that defines accountability of QI committee• Defines frequency of reports to Board of Directors• Defines time frame for updating QI plan and schedule

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QI Committee for Multiple Sites

• Still one QI committee for organization• Site QI committees may be established and described in

overall QI plan• Site QI plans must mirror overall plan and report on a

regular basis to overall QI committee• Main QI plan sets agenda for organization

– Additional QI projects may be done at satellites based on center needs in addition to main QI program

• Reporting from each site is very important in the overall QI committee

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Methods for QI Activities

• QI plan should include methods used to conduct QI projects• Includes process for collecting data and sources• Allocation of resources defined• Process most common: Improvement Model and use of

PDSA Cycle• Schedule of activities for monitoring measures• Defines QI activities based on subcommittees

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Tracking of QI Activities

• Defines reports to be given by subcommittees to overall organizational QI committee

• QI activities reported by subcommittees to overall QI committee– Report baseline on project, interventions attempted,

results of interventions and continued monitoring• Committee members track measures over time for QI

activity impact

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Approval and Review

• Identifies individuals who must approve QI plan• Signature page in place with dates • Appropriate signatures in place on review page• Frequency of review and updates for individuals who are

responsible for approval

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QI/QA Committee Meeting Minutes

• Committee minutes are important and key to confirm implementation of QI/QA plan

• Should be enough information for reviewer to verify successful implementation of QI program

• Provide written documentation of QI activities• Must include information on monitoring activities for

measures listed in QI plan• Must document multidisciplinary team by name and title

during attendance• Must report on QI activities conducted during meeting

interval• Data used to measure objectives of QI plan and track

improvement activities63

Include:• Attendees• Agenda items• Discussion topics• Recommendations• Action items• Clearly label with • consistent titles• Provide sufficient detail

Sample QI Meeting Minutes

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Conducting the QI Meeting

• Agenda should always be set– Review QI data/progress toward goals– Analyze trends and identify problem areas– Brainstorm for improvement strategies– Develop improvement plans

• Develop, revise and implement QI plans• Document meeting minutes and keep on file

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QI/QA Reports to Board

• QI/QA information reported at least 6 times• Board meeting minutes reflect:

– QI committee findings and activities– Objectives, data, improvement goals – Board review of QI plan on a regular basis (usually

annually)

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Submission of Information for FTCA

• Submit QI plan as developed by organization with appropriate signatures and approval

• Must also indicate board review during last three years• Meeting minutes:

– 6 months of QI meeting minutes– 6 months of Board meeting minutes with reports from QI

program– Multiple site minutes

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Questions for Day One

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Part 2 Tomorrow, February 21, 2013

At 1:30pm EST

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