D04_VHA_Handbook_1100.18_Reporting_and_Responding_to_State_Licensing_Boards.pdf

Department of Veterans Affairs Veterans Health Administration Washington, DC 20420

VHA HANDBOOK 1100.18

Transmittal Sheet

December 22, 2005

REPORTING AND RESPONDING TO STATE LICENSING BOARDS

1. REASON FOR ISSUE. This revised Veterans Health Administration (VHA) Handbook contains requirements for health care facilities’ procedures regarding reporting and responding to State Licensing Boards (SLBs).

2. SUMMARY OF MAJOR CHANGES. The major change is to provide for the review of non-sensitive evidence packages for compliance with information law requirements to be performed by Privacy Officers so designated by the Veterans Integrated Services Network (VISN) Director. Those cases determined to be sensitive in nature under this policy will continue to be submitted to the Deputy Under Secretary for Health for Operations and Management (10N), and for legal review by the Office of General Counsel (02).

3. RELATED ISSUES. None

4. RESPONSIBLE OFFICE. The Office of Quality and Performance (10Q) is responsible for the contents of this VHA Handbook. Questions may be addressed to 202-273-8936.

5. RESCISSIONS. VHA Handbook 1100.18, dated February 17, 2004, is rescinded.

6. RECERTIFICATION. This VHA Handbook is scheduled for revision or recertification on or before the last working day of December 2010.

S/ Jonathan B. Perlin, MD, PhD, MSHA, FACP Under Secretary for Health

DISTRIBUTION: CO: E-mailed 12/23/05 FLD: VISN, MA, DO, OC, OCRO, and 200 – E-mailed 12/23/05

T-1

December 22, 2005 VHA HANDBOOK 1100.18

CONTENTS

REPORTING AND RESPONDING TO STATE LICENSING BOARDS

PARAGRAPH PAGE

1. Purpose

2. Authority

3. Background

4. Definitions

5. VA-Initiated Reporting of Licensed Health Care Professionals to SLB

6. Five-day Alert Notice and Expedited Review Procedure Required for Statistical Association and Egregious Performance Cases

7. Entering Agreements that Would Prohibit or Restrict Disclosure

8. Responsibility

9. The SLB Reporting Stages; Creating and Filing Related Records

10. The Initial Review Stage

11. The Comprehensive Review Stage

12. The Decision Stage

13. The Concurrence Stage

14. The Reporting Stage

15. Responding to Inquiries from SLB

16. Interim Response to SLB Inquiry when VA is Considering Reporting on its own Initiative

APPENDICES

A. Overview of the Five-stage State Licensing Board Reporting Process .............................. A-1 B. Guidelines for Compiling, Organizing and Preparing the State Licensing Board

Reporting File .................................................................................................................... B-1 C. Guidance for Privacy Officers on Reporting File Review ................................................... C-1 D. Sample Special Reporting Procedures Alert Letter to State Licensing Board .................... D-1 E. Sample Advisement Notice to Licensed Health Care Professional ...................................... E-1 F. Sample Notice of Intent to Report Licensed Health Care Professional ................................ F-1 G. Sample Rebuttal Resolution Memorandum ........................................................................ G-1 H. Sample Decision Memorandum from an Organizational Head such as a VA Medical Center Director (00) to General Counsel (024) ................................................................ H-1 I. Sample Reporting File Review Memorandum from Privacy Officer …………………......... I-1 J. Sample Reporting Letter to State Licensing Board ................................................................ J-1 K. Sample Privacy Act Subsection (b) (7) Letter From State Licensing Board (SLB)

Requesting VA’s SLB Reporting File ............................................................................. K-1 i

REPORTING AND RESPONDING TO STATE LICENSING BOARDS

1. PURPOSE

It is the Department of Veterans Affairs (VA) policy to cooperate with State Licensing Boards (SLBs) after VA initiates a report and whenever there is an inquiry from an SLB regarding a VA licensed health care professional, whenever possible. This Handbook sets forth policies and procedures to be carried out by Veterans Health Administration (VHA) for:

a. Reporting licensed health care professionals to SLBs as a VHA initiative;

b. Responding to SLB in response to inquiries regarding VHA licensed health care professionals.

NOTE: Requirements for reporting to the National Practitioner Data Bank (NPDB) are outlined in the VHA Handbook 1100.17.

2. AUTHORITY

a. VA has broad authority to report to SLBs those employed or separated health care professionals whose behavior or clinical practice so substantially failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients.

The authority to report those professionals is derived from VA’s long-standing statutory authority, contained in Title 38 United States Code (U.S.C.) §§ 501, 7401-7405, which authorizes the Under Secretary for Health, as head of VHA, to set the terms and conditions of initial appointment and continued employment of health care personnel as may be necessary for VHA to operate health care facilities. This authority includes requiring health care professionals to obtain and maintain a current license, registration, or certification in their health care field.

b. The Veterans Administration Health Care Amendments of 1985, Public Law 99-166, and Part B of Title IV of Public Law 99-660, the Health Care Quality Improvement Act of 1986, are both Acts which authorize and require VHA to strengthen quality assurance and reporting systems to promote better health care. Pursuant to Section 204 of Public Law 99- 166, VA established a comprehensive quality assurance program for reporting any licensed health care professional to SLBs who:

(1) Was fired or who resigned following the completion of a disciplinary action relating to such professional’s clinical competence;

(2) Resigned after having had such professional’s clinical privileges restricted or revoked; or

(3) Resigned after serious concerns about such professional’s clinical competence had been raised, but not resolved.

c. The statutory provisions of 38 U.S.C. §§501, 7401-7405, augmented by Public Laws 99- 166 and 99-660, provide VHA ample authority to make reports to SLBs when exercised consistent with Privacy Act requirements for release of information.

VHA HANDBOOK 1100.18 December 22, 2005

3. BACKGROUND

a. VA is responsible for ensuring that its patients receive appropriate and safe health care. Similarly, VA has an obligation to reasonably ensure that its health care staff meet or exceed generally-accepted professional standards for patient care and, as such, has the obligation to alert those entities charged with licensing health care professionals when there is serious concern with regard to a licensed health care professional's clinical practice. This obligation includes notifying SLBs of VA's concern with regard to the clinical practice of current or former professionals, and responding to inquiries from SLBs concerning the clinical practice of those professionals.

b. VA has a responsibility to protect the privacy rights of its current and former professionals in the reporting process. VA ensures such protection by conforming to the disclosure requirements of Federal information law, including the Privacy Act, when initiating disclosure or responding to inquiries from SLBs. However, the guiding principle is making patient safety the paramount consideration.

c. The rationale for reporting professionals under the continuing jurisdiction and supervisory control of VA, for deficiencies which might impact on the safety of patients in a board’s jurisdiction, is as follows:

(1) Many licensed health care professionals who provide health care services to VA beneficiaries are not exclusively under the control of VA. These professionals may provide health care services to patients, other than VA beneficiaries, elsewhere under a board’s jurisdiction. These professionals include part-time, intermittent, on- and off-station fee basis and full-time professionals who may be involved in health care activities outside their full-time VA employment.

(2) VA must avoid even the appearance of “sheltering” or “protecting” its professionals from reasonable reporting standards which apply in the non-VA health care community.

4. DEFINITIONS

a. Generally-accepted Standards of Clinical Practice. Generally-accepted standards of clinical practice are the level of ability and practice expected of competent professionals, as well as the moral and ethical behavior necessary to carry out those responsibilities.

b. Reasonable Concern for the Safety of Patients. Reasonable concern for the safety of patients is when, given all the circumstances, a reasonable person would be concerned for the safety of patients treated by the licensed health care professional.

c. Licensed Health Care Professional. A licensed health care professional is an individual appointed or utilized under 5 U.S.C. or 38 U.S.C. on a full-time, part-time, intermittent, off-station or on-station, fee basis; contract basis, or sharing agreement basis;

either permanent or temporary, whether paid or without compensation, who is licensed, certified or registered in a health care profession (such as a physician, dentist, podiatrist, optometrist, chiropractor, nurse, physician assistant, expanded-function dental auxiliary, physical therapist, practical or vocational nurse, pharmacist, social worker, occupational therapist, or certified or registered respiratory therapist). It includes licensed residents, consultants, and attendings. As used in this Handbook, the term "licensed health care professional" also refers to a licensed health care provider appointed to a position in an occupation where appointment in VA does not require licensure or certification (such as a speech pathologist, psychologist, dietitian, or audiologist). As used in this Handbook, it also refers to licensed individuals working outside their licensed occupation, such as a registered nurse appointed to a Title 5 U.S.C. position, in any organizational unit or section of VHA, including Network offices and Central Office.

d. Licensure. Licensure is the official or legal permission to practice in an occupation, as evidenced by documentation issued by a State in the form of a license and/or registration.

e. Certification. Certification is the documentation issued by a recognized health care organization or other established entity, such as a State attesting to minimum competence in a health care field.

f. Separated Licensed Health Care Professional. A separated licensed health care professional is any licensed health care professional no longer on VA rolls and who left VA for any reason. This includes both voluntary and involuntary reasons, including disability retirement.

g. Currently Employed Licensed Health Care Professional. A currently employed licensed health care professional is any licensed health care professional who is on VA rolls for the provision of health care services, regardless of the status of the professional, such as full-time, part-time, contract service, fee basis, or without compensation.

h. Substantial Evidence

(1) Substantial evidence is the degree of relevant evidence that permits a reasonable person to conclude that there is a solid, material basis for believing that the professional is engaged in a substandard act which created a reasonable concern for patient safety.

(2) Substantial evidence of wrongdoing is more than a mere suspicion, or uncorroborated hearsay or rumor.

(3) For SLB reporting purposes, this definition focuses more on the quality and believability of the evidence than the quantity of the evidence. Substantial evidence of wrongdoing can be present, however, even if all the evidence, taken together, would lead a reasonable person to conclude that, more likely than not, no wrongdoing occurred.

5. VA-INITIATED REPORTING OF HEALTH CARE PROFESSIONALS TO AN

SLB

a. VHA facilities (and other components) must report on their own initiative (after determining, through a process defined in this Handbook, that the appropriate Privacy Act requirements have been met) each licensed health care professional whose behavior or clinical practice so substantially failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients.

b. This applies to all VHA professionals at all levels and organizational units whether or not the conduct is directly related to the provision of VA health care, and whether or not the conduct occurred while in a duty status. The report must be submitted to each SLB where the professional holds a license. The following are examples of substandard actions which would ordinarily provide a reasonable basis for a concern for the safety of patients, and as such, would be reported:

(1) Significant deficiencies in clinical practice, for example: lack of diagnostic or treatment capability; multiple errors in transcribing, administering, or documenting medications; inability to perform clinical procedures considered basic to the performance of one's occupation; or performing procedures not included in one's clinical privileges in other than emergency situations.

(2) Patient neglect or abandonment.

(3) Mental health impairment sufficient to cause the individual to: make judgment errors affecting patient safety, behave inappropriately in the patient care environment, or provide unsafe patient care.

(4) Physical health impairment sufficient to cause the individual to provide unsafe patient care.

(5) Substance abuse when it affects the individual's ability to perform appropriately as a health care provider or in the patient care environment.

(6) Falsification of credentials.

(7) Falsification of medical records or prescriptions.

(8) Theft of drugs.

(9) Inappropriate dispensing of drugs.

(10) Unethical behavior or moral turpitude (such as sexual misconduct toward any patient involved in VA health care).

(11) Patient abuse, including mental, physical, sexual, and verbal abuse, and including:

(a) Any action or behavior that conflicts with a patient's rights identified in Title 38, Code of Federal Regulations (CFR);

(b) Intentional omission of care;

(c) Willful violations of a patient's privacy; and/or

(d) Willful physical injury, or intimidation, harassment, or ridicule of a patient.

(12) Falsification of research findings, regardless of where the research was carried out or the funding source, as long as it was involved in some aspect of VA operations.

c. When a decision is reached to initiate SLB reporting regarding a currently employed professional, a decision may also be made to initiate appropriate disciplinary proceedings or to place the professional in a non-clinical environment. NOTE: Reporting to an SLB is to allow the SLB to proceed on its own time schedule and independent of the time requirements of any other proceedings in order to avoid unacceptable delays. Disciplinary actions are based on a preponderance of evidence process; in contrast, reporting to an SLB requires only a finding that there is substantial evidence that the reporting test was met.

NOTE: Reporting to an SLB in accordance with this policy is a separate and distinct process from reports filed with SLBs submitted subsequent to reporting to the NPDB in accordance with other VHA policies. Reporting under the requirements of one policy does not relieve the facility from meeting its obligation under any other VHA policy, e.g., requirements to report to an SLB in accordance with VHA Handbook 1100.17.

d. A VA-initiated report to an SLB (after a determination that the appropriate Privacy Act requirements have been met) is only notice to an SLB that there is a question of a professional’s clinical practice or behavior. Reporting is not a VA action against a professional’s license. The SLB may or may not, according to its standards, follow-up and obtain relevant portions of the VA SLB Reporting File, or ultimately, undertake formal proceedings against the license of the professional.

e. In the event there has been a court conviction, the public documents related to that conviction may be provided directly to appropriate SLB by the responsible organizational head without further review.

6. FIVE-DAY ALERT NOTICE AND EXPEDITED REVIEW PROCEDURE REQUIRED

FOR STATISTICAL ASSOCIATION AND EGREGIOUS PERFORMANCE CASES

NOTE: Egregious performance is defined as conduct by a licensed health care professional that causes the facility Director, or designee, to summarily remove the professional from clinical duties because of an immediate and urgent concern for the safety of patients.

a. Special procedures are required when a statistically-significant association links a licensed health care professional to a series of unexpected events that have resulted in patient injuries or deaths, or when egregious performance by a licensed health care professional is found.

Statistical significance is established at the .05 level of confidence, using generally-accepted statistical methods.

b. When a determination is made of either a statistical association or egregious performance, two immediate actions are required.

(1) The facility Director must commence an SLB Reporting Program review, as outlined in this Handbook, on an expedited basis.

(2) Within 5 days of the determination, the facility Director must provide to each SLB where the professional is licensed, an alert of the statistical association or the egregious performance, and concurrently provide a copy of the alert to the Veterans Integrated Service Network (VISN) (10N___), the Deputy Under Secretary for Health for Operations and Management (10NC), the Office of the Medical Inspector (10MI), and the General Counsel (02).

c. The alert must be prepared in the same format as shown in Appendix D. It will:

(1) Identify only the occupational title of the professional, such as physician, nurse, or pharmacist.

(2) Describe either the unexpected events that are statistically linked to that professional or the egregious performance.

(3) Disclose that an expedited review is being conducted to determine if there is a non-statistical nexus between the professional and the unexpected events in a statistical case, or to develop additional information in an egregious performance case.

(4) Notify the Board, that upon completion of the review, it will be advised of whether substantial evidence does or does not exist to indicate that the professional failed to meet generally-accepted standards of clinical practice that have caused the concern for patient safety.

(5) Assure the Board that, while the professional will be reported by name consistent with Privacy Act requirements to each SLB (s) where the professional is licensed, if substantial evidence exists to establish a statistical linkage or substandard performance, it may nevertheless at any time during the review, obtain the name of the licensed professional and further information, by making a request consistent with subsection (b)(7) of the Privacy Act (see App.

K for sample request letter). This provision is an exception to the paragraph 16 of this Handbook. Any information disclosed under a subsection (b)(7) of the Privacy Act request that identifies a specific professional must also be provided to that professional.

7. ENTERING AGREEMENTS THAT WOULD PROHIBIT OR RESTRICT

DISCLOSURE

VHA Directors, heads, and other employees are not authorized to, and must not enter into any formal or implied agreement that would prohibit or interfere with the reporting of a licensed health care professional to an SLB, or destroy or remove any information needed in the review process in return for a personnel action, such as resignation, retirement, or reassignment. Any such purported agreement is not binding upon VA and such an agreement forms the basis for administrative and/or disciplinary action.

8. RESPONSIBILITY

The head of each organizational component of VHA has overall responsibility for VA-initiated reporting to an SLB and responding to inquiries from an SLB. For example, VISN Directors are responsible at the VISN level and facility Directors at the facility level.

9. THE SLB REPORTING STAGES; CREATING AND FILING RELATED RECORDS

a. The SLB Reporting Program involves five stages:

(1) Initial Review Stage;

(2) Comprehensive Review Stage;

(3) Decision Stage;

(4) Concurrence Stage; and

(5) The Reporting Stage.

NOTE: These five stages normally are completed in about 100 days. An overview of the tasks, records to be created, and procedures is provided in Appendix A with suggested timeframes.

b. Guidelines for compiling and organizing the SLB reporting file are contained in Appendix B.

c. The records created or compiled in connection with this reporting, including any Stage, are to be filed and retrieved by the name of the licensed health care professional and are to be maintained in Privacy Act System of Records 77VA10Q, Health Care Provider Credentialing and Privileging Records – VA, regardless of whether the professional has a credentialing folder.

10. THE INITIAL REVIEW STAGE

The Director, or head, must ensure that within 7 calendar days of the date a licensed health care professional leaves VA employment, or, information is received suggesting that a current employee’s clinical practice has met the reporting standard, an initial review of the individual's clinical practice is conducted to determine if there may be substantial evidence that the individual so substantially failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients. Usually this review is conducted and documented by first and second level supervisory officials. There must be reasonably-detailed documentation that this review was performed. NOTE: When the initial review indicates that a professional has retired for disability reasons, a comprehensive review is always required and reporting of that professional is usually indicated.

11. THE COMPREHENSIVE REVIEW STAGE

a. Failure to Meet Accepted Standards. When the initial review suggests that there may be substantial evidence that the licensed health care professional so failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients, the Director, or head, of the organizational component, is responsible for immediately initiating a comprehensive review to determine whether there is, in fact, substantial evidence that this reporting standard has been met. This involves the preparation of an SLB Reporting File. The objective of the comprehensive review is to present a balanced and complete picture in the file of the circumstances which formed the basis for the concern. Consistent with information law requirements, the Director, or head, must ensure that the reviewer advises the licensed health care professional, as soon into the comprehensive review as is practicable, of the purpose of the review and invite the professional to provide information. The information conveyed to the professional must include the information contained in Appendix E. If the Advisement Notice is sent by mail rather than delivered in person, Certified Mail, Return Receipt Requested must be used. The notification procedures must be followed in providing the Advisement Notice.

b. Conflicting Evidence. The reviewer needs to be advised to identify in the review any significant conflicting evidence, make reasonable effort to decide what the more believable conflicting evidence seems to be, and set out in the review, the rationale for believing one position over another.

(1) The comprehensive review may or may not conclude that there is substantial evidence that:

(a) There was substandard care; and

(b) That some or all of the substandard care creates a reasonable concern for the safety of patients regarding each concern.

(2) Prior to sending the Notice of Intent to Report and the evidence gathered is determined not to be substantial evidence that would support a charge in the Notice of Intent to Report, this evidence must be preserved and marked “Review Material – Not Substantial Evidence” and maintained as marked in 77VA10Q under the professional’s name.

c. SLB Reporting File. The SLB Reporting File consists of three parts: Evidence File, Notice of Intent to Report, and the Response and Rebuttal Resolution Memorandum. The Evidence File must be prepared as required by this Handbook. All parts of the file must be compiled and organized in accordance with the instructions in Appendix B.

d. Notice of Intent to Report. When the Evidence File indicates that there is substantial evidence that the reporting standard has been met, a Notice of Intent to Report must be provided by the reviewer to the licensed health care professional. A notice assists in satisfying information law requirements that reasonable efforts be made to ensure that the Evidence File information is timely, accurate, relevant, and complete. Each licensed health care professional being considered for reporting to an SLB must be provided a notice or at least a reasonable attempt to provide a notice is to be made. The notice must list each charge, and provide a brief but reasonably detailed description of the facts giving rise to each charge.

The description must be sufficiently clear and precise so that the professional can understand exactly what circumstances are giving rise to each charge and what the exact wrongdoing was. A charge not contained in the notice may not be disclosed to an SLB. Accordingly, the Index of Charges from the Evidence File must be copied verbatim into the Notice of Intent to Report, except for tab page references, and patient identifiers, which must not be included.

In order to meet information law requirements, the content of the Notice of Intent to Report must conform to the sample Notice of Intent to Report letter contained in Appendix F.

e. First Notice of Intent to Report. The Notice of Intent to Report requirement is satisfied by the use of a Certified Mail, Return Receipt Requested letter. A memorandum or other alternative notification method is acceptable, if all of the information contained in the Notice of Intent to Report letter (see App. F), is included in writing to the professional who acknowledges receipt or there is other proof of receipt. Proof of notice, such as a signed Certified Mail Return Receipt or a witness statement, must be added to the SLB Reporting File in the location indicated in Appendix B.

f. Second Notice of Intent to Report. A second Notice of Intent to Report must be sent, Certified Mail, Return Receipt Requested, should there be no written acknowledgment from the professional of the Notice of Intent to Report certified mail letter and the notice was not returned within 15 days of the mailing date. Reasonable effort must be made to determine the correct current address of the licensed health care professional if it is unknown, or if there is a question before sending a second notice. This includes contacting the SLB and professional organizations, and developing other leads that could include prospective employers and references. If the second Notice of Intent to Report is unsuccessful, the reviewer must proceed after documenting in the file the efforts to provide notice.

g. Licensed Health Care Professional Request for Evidence File. Should the professional ask for the evidence being used to make the determination, the evidence must be provided in a manner to ensure receipt and acknowledgment of delivery, such as by Certified Mail, Return Receipt Requested, using a consistent anonymous patient identification after patient identifiers have been redacted. The professional has an additional 14 days from the date of receipt to respond and must be so advised.

h. Response of the Professional and Rebuttal Resolution Memorandum. Whenever a licensed health care professional responds to, and contests, any of the charges, the reviewer must consider each contested, or rebutted, charge and address each in a Rebuttal Resolution Memorandum similar in format to the sample in Appendix G. The reviewer must consider the evidence on both sides of a contested point and make a decision on which to believe.

Making this determination may involve obtaining additional evidence. It always requires at least an explanation as to how the reviewer has resolved the conflict. The resolution might, involve believing one person’s word over another’s; where that is the case, a short explanation of why one over another was believed needs to be entered in the Memorandum.

For another example, if physical abuse is the charge, and the professional responded that the patient provoked the situation by striking first, the Memorandum addresses this argument by stating the employee’s rebuttal point and resolving it with a statement to the effect that there is no acceptable reason to strike a patient. It is possible that a professional’s response demonstrates that a particular charge is unfounded; in that case, the charge and the supporting evidence must be deleted from the Evidence File, Notice of Intent to Report, the

Response, and wherever else they may appear in the SLB Reporting File before it is forwarded for concurrence. In such instances, that evidence must be preserved and marked “Notice to Report – Not Substantial Evidence” and maintained as marked in 77VA10Q under the professional’s name. The Response and Rebuttal Resolution Memorandum material must be added to the SLB Reporting File at the point indicated in the Guidelines in Appendix B.

NOTE: For some additional guidance see the discussion of Resolution of Conflict in the Unit of Evidence in Appendix B.

NOTE: It is the intent of this policy to make determinations based on all information reasonably and timely available. However, strict adherence to time limits must not be utilized to defeat this process. It is expected that VA would consider a late reply to a Notice of Intent to Report letter; similarly, late action by VA would not be a bar to further processing or to reporting.

12. THE DECISION STAGE

a. Upon completion of the Comprehensive Review Stage, the Director, or head, must decide whether to report the licensed health care professional. The entire Evidence File, Notice of Intent to Report documentation, and any Response and Rebuttal Resolution Memorandum materials, must be considered in determining whether there is substantial evidence that, as to each charge in question, the professional so substantially failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients. The determination ordinarily needs to be made within 7 calendar days after the Response segment of the Comprehensive Review has been completed.

b. It should be noted that not infrequently three or four charges, taken together, may result in a sufficient basis to warrant reporting. On occasion, during the Comprehensive Review process, some or even all of the charges may be dropped. Where some, but not all, of the charges are dropped, the remaining charges may or may not be sufficient to warrant reporting.

c. The Director, or head, may wish to consult with and consider recommendations from appropriate clinical service chiefs as to whether the reporting standard has been met for each of the charges. When a decision is made not to report a professional, the file is to be appropriately noted and the professional so advised.

d. When the Director, or head, decides to report the licensed health care professional, that official must add a Decision Memorandum to the file following the format in Appendix H. The Decision Memorandum must contain the following information:

(1) A statement that the Director, or head, has made a decision based upon consideration of the entire SLB Reporting File to report a licensed health care professional, providing the name and professional title (M.D., R.N.) of the individual and the SLB to whom the report is to be made;

(2) Intended Reporting Statement. In accordance with Congressional intent to maintain appropriate confidentiality for the professional, the intended reporting statement is to be limited to a generic description of the clinical shortcomings involved, such as, “Dr. Fictitious W. Jones so failed to meet generally-accepted standards of clinical practice as to raise reasonable concern for the safety of patients when Dr. Jones repeatedly erred in the selection of appropriate medications.”

(3) A statement that all portions of the SLB Reporting File have been compiled and organized as required in Appendix B, and in particular: the Advisement Notice procedure, the Notice of Intent to Report procedure, and the Rebuttal Resolution Memorandum procedure have been met and at what tab or page number in the file that documentation can be found.

(4) Confirmation that the SLB Reporting File is maintained in VA’s Privacy Act System of Records 77VA10Q, Health Care Provider Credentialing and Privileging Records - VA, and that this disclosure is authorized under the SLB routine use contained in that system.

(5) A statement indicating all unsubstantiated or irrelevant information has been removed from the file. To enable review, only the records proposed to be disclosed should be submitted. Redactions or withholdings should include: charges and related information for which substantial evidence was lacking or harmful, personal information irrelevant to the sustained charges, and personal identifiers of patients.

(6) Any narrative or other material considered desirable to clarify, draw attention to, or otherwise augment the SLB Reporting File.

(7) A statement indicating that a copy of the file, as proposed, is being provided to the SLB and in an unredacted fashion, and must be maintained.

(8) A request for general review of the file, Decision Memorandum, and concurrence or comments based on the review by either a Privacy Officer in the VISN, or the Office of General Counsel as appropriate, and determined in accordance with guidance outlined in subparagraph 13a.

13. THE CONCURRENCE STAGE

a. Within 5 calendar days of deciding to report, the facility Director, or head, must decide if the case review is a non-sensitive or sensitive case. A case is determined to be sensitive if it indicates one of the following scenarios:

(1) A previous history of licensure action;

(2) Death of a patient;

(3) The professional who is the subject of the review has retained legal counsel in anticipation of litigation;

(4) There has been media attention associated with some aspect of the incident or subject of the review; or

(5) The professional who is the subject of the review has a clinical diagnosis or is under the care of a physician, and that this information is part of the review or rebuttal process.

b. If the case is determined to be non-sensitive, the Decision Memorandum is forwarded to the VISN Director for concurrence and assignment to a Privacy Officer in a different facility within the VISN for determination as to whether VA has met its obligations under all disclosure authorities in connection with the decision to report.

(1) The VISN Director forwards to the designated facility Privacy Officer the complete SLB Reporting File consisting of the: Evidence File, Notice of Intent to Report documents, any Response and Rebuttal Resolution Memorandum materials, and the Decision Memorandum. A copy of the VISN Director’s concurrence and the assignment memorandum is forwarded to the Deputy Under Secretary for Health for Operations and Management (10NC).

(2) Within 60 calendar days, the designated facility Privacy Officer must review the SLB Reporting File and evaluate whether:

(a) There is legal authority under Federal laws and regulations for the proposed reporting, and efforts have been made to ensure that the file is reasonably accurate, relevant, and complete.

(b) The licensed professional has been provided adequate notice of the proposal to report and has had the opportunity to submit information for consideration, as indicated by an Advisement Notice, a Notice of Intent to Report, any response of the professional, and a Rebuttal Resolution Memorandum, if applicable.

(c) The Reporting File does not contain information inappropriate for disclosure to the SLB, for example, quality assurance information protected under 38 U.S.C. 5705, records governed by 38 U.S.C. 7332 , and information gathered but insufficient to support a charge in the Notice of Intent to Report.

(d) The file is consistent with the guidelines of Appendix B of this Handbook, as follows:

1. The Decision Memorandum conforms to the requirements of this Handbook.

2. The Evidence File contains: an Advisement Notice, Index of Charges, evidence set off in a separate unit of evidence for each charge and organized in order corresponding to the Index, and adequate documentary support for each charge, including information regarding standards breached, harm to patients, and resolution of any conflicting evidence.

3. The Notice of Intent to Report document is present in the correct form and location in the file.

4. Any Response and Rebuttal Resolution Memorandum materials are included in the correct location in the file.

(3) A Reporting File that does not conform to the guidelines discussed in this Handbook must be returned by the facility Privacy Officer through the VISN Office to the facility Director for the file to be supplemented with additional information, or revised and resubmitted for further review.

(4) If the review by the Facility Privacy Officer determines that there is disclosure authority under Federal laws and regulations, the SLB Reporting File and Memorandum must be returned to the facility with the Privacy Officer’s concurrence with the proposed reporting. The Privacy Officer’s memorandum (see App. I) must contain information on actions taken and any other guidance necessary to complete the preparation of the file for submission to the SLB. The facility Privacy Officer completing the review forwards a copy of the memorandum of concurrence and the proposed reporting memorandum to the Deputy Under Secretary for Health for Operations and Management (10NC).

(5) If the facility Privacy Officer determines that the case is a sensitive case that requires legal review under preceding subparagraph 13a, the file must be returned to the VISN Director to be transferred through Deputy Under Secretary for Health for Operations and Management (10NC) to General Counsel (024). The VISN Director must then follow the procedures outlined in subparagraph 13.c. below.

c. If the case is determined to be sensitive, the Decision Memorandum must be addressed to General Counsel (024), through the Deputy Under Secretary for Health for Operations and Management (10NC) and forwarded through the VISN Director for concurrence. NOTE:

Do not submit the SLB reporting file directly to General Counsel.

(1) Within 5 calendar days of the receipt of the SLB Reporting File, and before forwarding the file to General Counsel, the Deputy Under Secretary for Health for Operations and Management (10NC) must review the package to ensure that the file is consistent with the guidelines of Appendix B of this Handbook, as follows:

(a) The Reporting File does not contain information inappropriate for disclosure to the SLB, for example, quality assurance information protected under 38 U.S.C. 5705, records governed by 38 U.S.C. 7332 , and information gathered but insufficient to support a charge in the Notice of Intent to Report.

(b) The Decision Memorandum conforms to the requirements of this Handbook.

(c) The Evidence File contains: an Advisement Notice, Index of Charges, evidence set off in a separate unit of evidence for each charge and organized in order corresponding to the Index, and adequate documentary support for each charge, including information regarding standards breached, harm to patients, and resolution of any conflicting evidence.

(d) The Notice of Intent to Report document is present in the correct form and location in the file.

(e) Any Response and Rebuttal Resolution Memorandum materials must be included in the correct location in the file.

(2) A Reporting File that does not conform to the guidelines discussed in this Handbook may be held by the Deputy Under Secretary for Health for Operations and Management (10NC), or returned to the facility for the file to be supplemented with additional information, or revised and resubmitted for further review.

(3) If the complete evidence does not demonstrate that the individual so substantially failed to meet generally-accepted standards as to raise reasonable concern for the safety of patients, the file must be returned to the facility without forwarding to General Counsel for legal review.

(4) Upon receipt of the Reporting File from the Deputy Under Secretary for Health for Operations and Management (10NC), General Counsel (024) reviews the file and evaluates whether:

(a) There is legal authority under Federal laws and regulations for the proposed reporting, and efforts have been made to ensure that the file is reasonably accurate, relevant, and complete.

(b) The licensed professional has been provided adequate notice of the proposal to report and has had the opportunity to submit information for consideration, as indicated by an Advisement Notice, a Notice of Intent to Report, any response of the professional, and a Rebuttal Resolution Memorandum, if applicable.

(c) The Reporting File does not contain information inappropriate for disclosure to the SLB, for example, quality assurance information protected under 38 U.S.C. 5705, records governed by 38 U.S.C. 7332 , and information gathered, but insufficient to support a charge in the Notice of Intent to Report.

(d) The file is consistent with the guidelines of Appendix B of this Handbook, as follows:

1. The Decision Memorandum conforms to the requirements of this Handbook;

2. The Evidence File contains: an Advisement Notice, Index of Charges, evidence set off in a separate unit of evidence for each charge and organized in order corresponding to the Index, and adequate documentary support for each charge, including information regarding standards breached, harm to patients and resolution of any conflicting evidence;

3. The Notice of Intent to Report document is present in the correct form and location in the file; and

4. Any Response and Rebuttal Resolution Memorandum materials are included, in the correct location in the file.

(5) General Counsel (024), upon completion of its review, must return the complete SLB Reporting File to the Deputy Under Secretary for Health for Operations and Management (10NC) with its memorandum concurring or objecting to the proposed reporting based upon information law requirements and the materials reviewed. Should the General Counsel memorandum concur in whole or in part with the proposed disclosure, it is anticipated that there may be recommendations consistent with confidentiality and reporting considerations, as to what information to report initially to the SLB and what information to subsequently disclose should the SLB request follow-up information. The Deputy Under Secretary for Health for Operations and Management (10NC) will return the SLB Reporting File to the originator with a cover memorandum authorizing or denying authority to report to the SLB.

14. THE REPORTING STAGE

The Director, or head, must send a reporting letter (sample in App. J) to the relevant SLB within 7 calendar days of receipt of a concurring legal review memorandum opinion from either the Privacy Officer who reviewed the evidence file or the General Counsel via the Deputy Under Secretary for Health for Operations and Management (10NC) following the format of the sample Reporting Letter to SLB in Appendix J. The letter to be released to the appropriate SLB should be limited, consisting only of the name and medical title of the professional and a generic description of the charges being reported, and it should be consistent with any guidance contained in the General Counsel memorandum. It needs to state what the SLB must do to obtain detailed information on the matter. A copy of the letter submitted to the SLB must be sent to the Deputy Under Secretary for Health for Operations and Management (10NC), the Office of the Medical Inspector (10MI) in VHA Central Office, and the professional. A letter from the SLB requesting follow-up information received by the facility must meet the Privacy Act, 5 U.S.C. § 552a, requirements identified in this Handbook to permit disclosure of the relevant portions of the SLB Reporting File (a sample request letter from a board is provided in App. K). All information to be released to the SLB is released only after patient identifiers have been deleted by redaction and replaced with consistent anonymous patient identifiers.

15. RESPONDING TO INQUIRIES FROM SLB

a. General

(1) As stated at the beginning of this Handbook, it is the policy of VA to cooperate whenever possible with an inquiry by an SLB. Accordingly, consistent with the procedures set out in this Handbook and applicable information law, VA health care facilities must provide reasonably complete, accurate, timely, and relevant information to an SLB in response to inquiries. Furthermore, while Federal Supremacy under the constitution could, under applicable circumstances, be invoked to prevent a State inquiry into the provision of care at a VA facility by a VA professional, consistent with the VA policy of cooperation with an SLB, the use of this doctrine to prevent such an inquiry will seldom, if ever, be authorized. For example, if a Director, or head, concludes, following a Comprehensive Review conducted in accordance with this Handbook, that the reporting standard has not been met and the VA inquiry is properly terminated, VA nevertheless will ordinarily cooperate with a subsequent inquiry initiated by an SLB, including making its SLB file available pursuant to a Privacy Act (b)(7) request and the health care oversight provisions of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR 164.512(d)), rather than to raise a Constitutional Federal Supremacy objection. Such an objection may be raised only upon concurrence by the Deputy Under Secretary for Health for

Operations and Management (10NC) following consultation with General Counsel (023).

(2) Because of the Privacy Act, a standing request for information, such as a request for information to be provided each time there is a clinical practice concern, cannot be honored. The SLB needs to request specific information on a professional by a signed consent or Privacy Act law enforcement investigation letter similar to the sample Letter of Inquiry from SLB found in Appendix K. If the specific information on a professional includes any health information of a patient, authority for providing such information under the HIPAA Privacy Rule must be present.

Reporting of information to the SLB and providing upon request additional information in regards to the case is authorized under the HIPAA Privacy Rule as a health care oversight activity (45 CFR 164.512(d)).

(3) Occasionally the Freedom of Information Act (FOIA) is cited by SLBs as authority to request information on professionals. Generally, FOIA does not permit disclosure about specific professionals. SLBs need to be advised to request the information with a signed consent from the individual in question or with a Privacy Act (b)(7) Law Enforcement Investigation Letter as outlined in subparagraph 15b.

b. Signed Consent

(1) A signed consent from the subject professional is sufficient to disclose information, covered by the Privacy Act, about a currently employed, or separated, VA health care professional, in response to a request from an SLB accompanied by the consent.

(2) When relying on the signed consent for disclosure authority, the consent must have been signed within the 6 months prior to the date of the disclosure. It must state the individual or organization to whom the information may be released and the type of information that may be released. It is suggested that all release of information be handled with the advice and consent of the local FOIA and/or Privacy Act Officer. Clarification may be sought from the Regional Counsel by that Officer in questionable cases, such as when VA receives a signed consent that specifies that VA may release any information “other than information that is derogatory,” or, when the consent does not specify the type of information that VA may release.

c. Privacy Act Subsection (b)(7), Law Enforcement Investigation Letter

(1) Generally, information compiled to meet the requirements of this Handbook will be released if an SLB’s request for that information meets the requirements of the Privacy Act, 5 U.S.C. 552a, subsection (b)(7), following essentially the format of the sample Privacy Act Subsection (b)(7), Law Enforcement Investigation Letter, in Appendix K. The request must:

(a) Be in writing on the SLB’s letterhead stationery.

(b) Cite the State law giving the SLB authority to take action against professionals who hold such a license, certification, or registration.

(c) Identify, specifically, the individual about whom information is sought, the records desired, and the law enforcement activity for which the information is sought. NOTE: This would usually indicate protection of the health of the State's citizens.

(d) Be signed by the head of the SLB or a person who has been designated to act for the head of the SLB. If a designee is to sign the request letter, to be effective:

1. The designee must be an official of sufficient rank to ensure that the request for records has been the subject of a high-level evaluation of the need for the information, even considering the privacy interests of the professional involved. Such an official would be at least at the supervisory level. NOTE: Generally, a request signed by a line investigator is insufficient.

2. The designation from…