Program Assistance Letter DOCUMENT NUMBER: PAL XX

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1 Program Assistance Letter DOCUMENT NUMBER: PAL XX DOCUMENT NUMBER: DATE: May 1, 2009 DOCUMENT TITLE: New Requirements for Medical Malpractice Coverage Deeming under the Federally Supported Health Centers Assistance Act for Calendar Year 2010 TO: Health Center Program Grantees Primary Care Associations Primary Care Offices National Cooperative Agreements I. PURPOSE II. This Program Assistance Letter (PAL) supersedes PAL for guidance on deeming requirements for organizations funded under the Health Center Program (section 330 of the Public Health Service (PHS) Act) and deemed as employees of the Public Health Service for purposes of Federal Tort Claims Act (FTCA) medical malpractice coverage under the Federally Supported Health Centers Assistance Act (FSHCAA) of 1992 and the FSHCAA of This PAL contains the instructions for health centers filing initial and renewal deeming applications for calendar year (CY) INTRODUCTION Federal Tort Claims Act (FTCA) coverage for eligible Health Center Program grantees was initially established through the FSHCAA of The eligible entities ("health centers") are organizations receiving funding under the Health Center Program (Community Health Centers, Migrant Health Centers, Health Care for the Homeless Centers, and Public Housing Primary Care Centers). Health centers are required to reapply each year for deeming and associated medical malpractice coverage. As a part of continued efforts to streamline and automate data reporting processes, the Bureau of Primary Health Care (BPHC) is developing a FTCA deeming module within the HRSA Electronic Handbooks (EHB) for the CY 2010 deeming period (January 1 December 31, 2010). This module will fully support electronic web-based functionality for the deeming process including: grantee completion and submission of applications; BPHC review and

2 processing of applications; and production of deeming status notifications to grantees. The module is expected to be available to Health Center Program grantees by June 2, This PAL is intended to help health centers prepare for the new FTCA deeming and redeeming submission requirements by indicating what information will be needed for the CY 2010 application submission. Additional information and training specific to the use of the webbased system will be made available closer to June 2, III. WHEN TO APPLY The FSHCAA of 1995 requires all health centers to apply for deemed status in order to obtain for FTCA coverage. A. INITIAL APPLICATION Health centers may submit an initial application at any time during the year. HRSA will act upon a complete application submission within 30 days. IV. B. RENEWAL APPLICATION All currently deemed health centers must file a renewal deeming application no later than July 17, 2009 in order to be deemed for CY In both cases, incomplete applications will not be processed until all missing items are completed. APPLICATION PACKET CHECKLIST To be considered complete, an initial or renewal application for CY 2010 must contain the following documentation: Application; Copy of the health center s Quality Assurance/Improvement Plan, with a notation of the last governing Board approval date for this plan; Staff list which includes all licensed and certified health care personnel employed and or contracted by the health center with the following information: o Name and Professional Designation (e.g., MD/DO, RN, CNM, DDS) o Title/Position o Specialty o Employment Status (full-time employee /part-time employee /contractor/volunteer) o Hire Date o Initial Credentialing Date (the first time the individual was credentialed by your organization) o Most Recent Credentialing Date; and o Next Expected Credentialing Date.

3 Summary of professional liability history for cases filed or closed within the last 5 years Explanation of No responses Deeming applications for any sub-recipient(s) (as documented on the organization s most recent FORM 5B) see VII below. V. GENERAL APPLICATION SUBMISSION INSTRUCTIONS To streamline FTCA deeming application submission and processing, it is required that health centers electronically submit their deeming application (initial or renewal) and supporting documents within the HRSA Electronic Handbook (EHB). The EHB module for FTCA application submission is expected to be available June 2, Additional information on this electronic system will be forthcoming in future correspondence. VI. SPECIAL CONSIDERATION ONLY FOR APPLICANTS UNABLE TO SUBMIT ELECTRONICALLY Health centers that are unable to submit their deeming applications electronically may submit a Waiver Justification letter that thoroughly explains the situation preventing submission through EHB along with their completed application to the following address: HRSA Health Center FTCA Program Attn: Vanessa Watters, Quality Branch Chief Bureau of Primary Health Care, HRSA 5600 Fishers Lane, Mailstop 15C-26 Rockville, MD Telephone: Fax: Waiver justifications are subject to review and approval by HRSA. VII. SUB-RECIPIENT APPLICATION SUBMISSION INSTRUCTIONS To ensure the completeness of application processing and review, health centers will be required to submit a separate deeming application on behalf of any sub-recipient identified on their most recent Form 5B that are seeking FTCA coverage. Sub-recipient organizations will be required to submit their applications and supporting documentation in accordance with the deeming guidelines specified within this PAL. VIII. CONTACT INFORMATION For further information and/or questions on the FTCA Program and the initial or renewal deeming application requirements for CY 2010, please contact:

4 1-866-FTCA-HELP ( ) 9:00 AM to 8:00 PM (EST) For technical support with BPHC systems, please contact: HRSA Call Center: Monday through Friday (except federal holidays) 9 AM to 5:30 PM (ET) BPHC Help Desk: Sincerely, Attachment James Macrae Associate Administrator for Primary Care

5 ATTACHMENT 1 Application for Health Center Program Grantees for Professional Liability Protection Under the Federal Tort Claims Act Fields indicated with a watermark will be auto-populated with data from the grants application within EHB SECTION I - APPLICANT INFORMATION APPLICATION TYPE (Please check one) INITIAL RENEWAL GRANTEE NAME: DBA Name (if appropriate): UDS #: GRANT #: Check all that apply: Community Health Migrant Health Health Care for the Homeless Public Housing Primary Care ADDRESS: Sub-Recipient TELEPHONE: FAX: SUB-RECIPIENTS APPLICATIONS INCLUDED (if appropriate): Grantees should indicate the name(s) of their sub-recipient(s) (as documented on FORM 5B) Copy of Sub-recipient Application Attached Copy of Sub-recipient Application Attached Copy of Sub-recipient Application Attached 5

6 EXECUTIVE DIRECTOR NAME: Telephone: MEDICAL DIRECTOR NAME: Telephone: RISK MANAGER NAME: DEEMING CONTACT NAME: (Individual responsible for completing application) Telephone: Telephone Number: 6

7 SECTION II REVIEW OF RISK MANAGEMENT SYSTEMS (Section 224(h)(1) Indicate Yes or NO to the following statements. NO responses require explanation on a separate sheet. The organization conducts periodic assessments to identify, prevent and monitor medical malpractice risk. There are policies/procedures on the appropriate supervision and back-up of clinical and non-clinical staff. YES NO A medical record is maintained for every patient of the health center. There are policies/procedures that address triage, walk-in patients, and telephone triage. There are clinical protocols that define appropriate treatment and diagnostic procedures for selected medical conditions. There is a tracking system for patients who require follow-up of specialty referrals, hospitalization, x-ray, and lab results. Medical records are periodically reviewed to determine quality, completeness, and legibility. Quality improvement/assurance findings are used to modify policies/procedures in order to improve quality of care. There is a written Quality Improvement/Assurance Plan (QI/QA Plan) approved by the governing board. If yes, attach a current copy of the QI/QA plan and include the approval date. NOTE: To help ensure confidentiality, please DO NOT submit actual agendas or minutes. For deeming purposes, the QI/QA Plan must include or describe the following elements under Sections 330(k)(3)(C) and 224(h) of the PHS Act and 42 CFR 51c.303(c)(1-2): Board Approval Date: Please indicate page where documented - There is a clear focus of responsibility to support the quality assurance/ improvement program and the provision of high quality patient care. - There is a periodic assessment of the appropriateness and quality of the services provided, or proposed to be provided, to individuals served by the applicant. - Assessments are conducted by physicians or by other licensed health professionals under the supervision of physicians; based on the systematic collection and evaluation of patient records; and identify and document the necessity for change in the provision of services by the applicant and result in the institution of such change, where indicated. 7

8 SECTION III REVIEW OF CREDENTIALING SYSTEMS (Section 224(h)(2)) Indicate YES or NO to the following statements. NO responses require explanation on a separate sheet. All health care personnel involved in direct patient care are credentialed at least every two years, including all of the following: - licensed independent practitioners (e.g., physicians, nurse midwives, nurse practitioners); - licensed practitioners (e.g., RNs, LPNs); - certified practitioners/technicians (e.g., dental, lab, radiology) 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 primary source verified for licensed independent practitioners secondary source verified for licensed and certified practitioners YES NO As part of the health center s credentialing process, each practitioner is required to submit evidence of each of the following for review including all of the following: - health fitness/fitness to perform duties - immunization status - professional references - certification in life support, as applicable - DEA registration, as applicable A National Practitioner Data Bank query is obtained and evaluated for each licensed practitioner as part of the health center s credentialing process. A history of previous malpractice liability claims and adverse actions (including FTCA claims) is reviewed for each practitioner and for your organization. The health center utilizes data from peer review and quality/performance improvement activities to support its credentialing functions, and these activities are overseen by its governing board. As part of the health center s privileging process, all of the following occurs: - practitioners are granted privileges by the health center, at least every two years, specific to the services being provided at each care delivery site; and - clinical privileges and medical staff membership at local hospitals and other admitting facilities are verified 8

9 SECTION IV REVIEW OF PROFESSIONAL LIABILITY HISTORY (Section 224(h)(3)) Please note: Health centers are expected to maintain their own records of medical malpractice claims as part of their risk management systems. Initial deeming applicants only. Please check one: No professional liability suits were filed or closed (by settlement or plaintiff verdict) against the health center and/or its employees/contractors over the last 5 years. Professional liability suits were filed or closed (by settlement or plaintiff verdict) against the health center and/or its employees/contractors over the last 5 years. - Applicants must provide a list of all professional liability claims or suits (including FTCA claims where applicable) filed or closed by settlement or plaintiff verdict against the health center and/or its employees/contractors over the last 5 years. Include the date of the complaint, the allegation, current status, and amount of payment, as applicable. - The listing should include a brief summary of the actions taken by the health center to analyze these incidents, the corrective actions taken or planned to prevent such claims in the future, and any resulting systems or clinical improvements, as applicable. Renewal deeming applicants only. Please check one: No professional liability suits were filed or closed (by settlement or plaintiff verdict) against the health center and/or its employees/contractors over the last 5 years. Professional liability suits were filed or closed (by settlement or plaintiff verdict) against the health center and/or its employees/contractors over the last 5 years. - Applicants must provide a list of pending FTCA claims, as well as FTCA claims closed by settlement or plaintiff verdict, over the last five years. The listing should include a brief summary of the actions taken by the health center to analyze these incidents, the corrective actions taken or planned to prevent such claims in the future, and any resulting systems or clinical improvements, as applicable. 9

10 SECTION V ADDITIONAL INFORMATION If your health center has achieved one or more of the following - recognition; - certification; or - accreditation Please indicate the name of the national recognition/certification/ accrediting body or [N/A] from a national review body by demonstrating the ability to meet nationally recognized standards, guidelines, and measures related to quality assurance and quality improvement in health care organizations. If your health center s personnel have participated in risk management training or continuing education within the past year. Please indicate the training title and sponsoring organization or [None] SECTION VI - SIGNATURES Completion of this section through either hand-written or typed name will constitute signature of this application. EXECUTIVE DIRECTOR NAME DATE Attachments to this application should include: Attachment A - Copy of Health Center s Quality Improvement/Assurance Plan Attachment B - List of Licensed or Certified Health Care Practitioners Attachment C - Review of Professional Liability History (as applicable) Attachment D - Explanation of No Responses, as necessary Attachment E - Sub-recipient Application(s) and Supporting Documentation (as applicable) 10

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