Chapter 1 - Clinical Credentials and Privileges

3-1.1 INTRODUCTION

1. Purpose.  The Clinical Credentials and Privileges chapter establishes operational policy, staff responsibilities, and organizational relationships for direct service facilities in the Indian Health Service (IHS or Agency) for the medical staff credentialing and clinical privileging of all licensed (registered or certified) practitioners (LPs) seeking to provide clinical care in IHS facilities and to appoint eligible individuals to the medical staff.  This policy is complemented by the IHS Clinical Credentials and Privileges Standard Operating Procedures (SOP) Manual (a standardized instructional manual) henceforth referred to as SOP Manual, to establish an IHS credentialing and privileging process that is standard, objective, systematic, and accountable to enhance patient safety by ensuring only appropriately screened and qualified LPs provide patient care services in the IHS health facilities.   
2. Background.  The IHS, an Agency within the Department of Health and Human Services, provides Federal health services to American Indians and Alaska Natives.

   The policy and processes for clinical credentialing and privileging of LPs is one of the critical tasks of the Agency and is directly related to the quality of health care provided at IHS facilities.  This chapter will be used along with the SOP Manual to create strong clinical credentialing and privileging requirements along with standardized, continuous, and verifiable processes, which decrease the potential for patient harm by verifying the professional education, training, licensing, current competence, and professional conduct of LPs.  The Agency is committed to supporting its mission to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level through standardized, high-quality, industry-based credentialing and privileging processes.

   The principal purposes and the intended results of this chapter are:

   1. To ensure that all LPs who seek to provide patient care are appropriately screened, credentialed, and privileged as necessary;
   2. To avoid exposing patients and facilities to unnecessary risks from unprofessional, unethical, or incompetent LPs; and
   3. To provide quality health care to patients.
3. Policy.  It is the policy of the IHS that all LPs who provide patient care shall be credentialed and privileged through the medical staff before providing patient care.
4. Scope.  This policy applies to all LPs providing or seeking to provide clinical services within any IHS directly-operated facilities or programs.  Tribal and Urban Indian health programs operating under the Indian Self-Determination and Education Assistance Act and the Indian Health Care Improvement Act, respectively, are encouraged to adopt this policy as appropriate but are not required to abide by this chapter.
5. Authorities and References. 
   1. Indian Health Care Improvement Act, 25 U.S.C. § 1601, et seq.
   2. Snyder Act, 25 U.S.C. § 13
   3. 25 U.S.C. § 1675
   4. Code of Federal Regulations (CFR) at 42 CFR § 482.12 and 482.22
   5. Privacy Act
   6. 5 C.F.R. Part 2635
   7. 45 C.F.R. Part 73
   8. Indian Health Service Medical Staff Credentialing and Privileging Standard Operating Procedures
6. Definitions.  For the purposes of this Chapter. 
   1. Applicant.  An individual who is applying for medical staff membership and/or privileges at an IHS facility.  This could be for an initial appointment, reappointment, or any type of specialty circumstances, such as disaster privileges or temporary privileges.
   2. Clinical Privileges.  The listing of the patient care services and clinical procedures that a LP has requested and been approved to perform or administer to patients in a specific health care facility. 
   3. Clinical Credentials and Privileges Standard Operating Procedures Manual.  A written manual containing instructions, definitions, workflow, processes, and/or other mechanisms for IHS credentialing and privileging to fulfill the requirements of this Chapter.
   4. Conditions of Participation.  Regulations promulgated by the Centers for Medicare & Medicaid Services (CMS) with which hospitals and other health care organizations must comply in order to participate in the Medicare Program.  The medical staff Conditions of Participation (CoPs) are located in the Code of Federal Regulations (CFR) at 42 CFR § 482.22 and the Governing Body CoPs are located at 42 CFR § 482.12. 
   5. Credentialing. The ongoing process of collecting, assessing, verifying, and documenting the professional credentials and qualifications of LPs, both new and renewing Medical Staff applicants.  This process includes verifying the current competency, character, judgment, education, and training of LPs.
   6. Credentialing by Proxy.  The process identified by CMS that allows hospitals to rely on a distant site hospital or telemedicine entity’s credentialing and privileging decisions through an agreement.  Although LPs providing telemedicine services are granted privileges, they are generally not offered medical staff membership.
   7. Credentialing and Privileging Software (Software).  The current credentialing and privileging software used by the IHS, is henceforth referred to as “Software” in this policy.
   8. Distant Site.  The location where a physician or practitioner providing the telehealth service is located.
   9. Executive Committee of the Medical Staff.  A representative group of the facility’s medical staff accountable to the Governing Body for the quality of care.
   10. Governing Board/Governing Body.  The governance authority that manages and provides oversight of the IHS facility.  The Governing Board/Governing Body (GB) has the authority to grant, modify, or deny medical staff membership and clinical privileges to LPs.
   11. IHS directly-operated facilities or programs.  A program, building, or part thereof wherein the IHS is operating an Indian health program directly pursuant to 25 U.S.C. § 1603(12)(A).
   12. Impairment.  The inability of an LP to provide health care with adequate competency and/or capacity such that the safety of patients could be or is endangered. 
   13. Initial Appointment.  The first admittance to the membership of the medical staff and/or granting of privileges at a facility.
   14. Licensed (or Registered or Certified) Practitioners.  A fully licensed, registered, or certified individual permitted by law and the facility to provide patient care services within the scope of their license, registration, or certification, and in accordance with individually granted clinical privileges.  All physicians are defined as LP (see Physicians definition below).  Furthermore, the GB has the authority, in accordance with applicable laws, to grant medical staff membership and/or privileges to non-physician practitioners identified as LP in the facility’s medical staff bylaws or Agency policies, to include:  physician assistants and advanced practice nurses, and may include, but is not limited to pharmacists, physical therapists, social workers, and psychologists.  For the purpose of this policy, designated non-physician practitioners will also be considered LPs.
   15. Medical Staff.  The body of the facility’s privileged LPs with a medical staff appointment, which operates under the facility’s medical staff bylaws approved by the GB and is responsible for the quality of clinical care provided to patients by the facility.
   16. Medical Staff Bylaws.  The framework and authoritative guidelines for the medical staff, which serve to define the organizational relationship among practitioners as individuals, practitioners as a group, and the health care facility as an entity.  These bylaws are the rules governing the responsibilities of the medical staff as a whole and of individual staff members.  These bylaws, often in concert with policies, rules, and regulations, outline every aspect of medical staff composition, membership, and committee activities and responsibilities, including credentialing and privileging.
   17. Medical Services Professional.  Also known as Credentialist, this individual assists the medical staff leadership with core administrative functions of credentialing and privileging health care providers in the IHS.  Some IHS Medical Services Professionals (MSP) may assist with additional medical staff functions, such as peer review and performance improvement.
   18. Optimize.  The act or process of making a system or process fully functional and as effective as possible.
   19. Peer.  Someone from the same clinical discipline.  For example, physicians for physicians, dentists for dentists, podiatrists for podiatrists, etc.  It does not have to be someone in the same clinical specialty (orthopedist, etc.).
   20. Physicians.  In addition to medical physicians (MD or DO), per Section 1861(r) of the Social Security Act, the following will also be considered physicians for certain purposes, including this policy:  Doctor of Dental Surgery or Dental Medicine; Doctor of Podiatric Medicine; Doctor of Optometry; and a Chiropractor.
   21. Privileging.  The process that health care organizations use to authorize LPs to provide specific clinical services to patients. 
   22. Reappointment.  The renewal of a medical staff membership and/or privileges at a facility.
   23. Service Unit.  Consistent with 25 U.S.C. § 1603(20), an administrative entity through which services are provided to eligible Indians within a defined geographic area; for purposes of this policy, the term is limited to facilities or programs operated directly by the IHS.
   24. Standardize.  To conform to an established standard set for fields and/or processes.
   25. Systemize.  To make a system more efficient and effective through arranging established standardization to an entire system.
   26. Temporary Privileges.  Privileges assigned to LPs that allow them to provide direct care services in a facility for a specific, limited amount of time.
   27. Verification.  Verification involves establishing the truth or validity of a proposed fact.

3-1.2 RESPONSIBILITIES

1. Area Chief Medical Officer.  The Area Chief Medical Officer (CMO) or a designee is responsible for:
   1. Providing oversight of credentialing and privileging of LPs at all Federal Service Units (SU) within their IHS Area, standardization of Area credentialing and privileging requirements, ensuring credentialing and privileging audits and internal controls are complete, and supporting the robust usage of the Software;  
   2. Participating in monthly IHS HQ Credentialing and Privileging calls to support the standardization, systemization, and optimization of credentialing and privileging in their IHS Area; 
   3. Providing input to the GB, Area MSP, SU Clinical Directors (CDs), among others, with respect to credentialing and privileging matters, as needed;
   4. Providing oversight of the clinical and privileging responsibilities of the SU CDs; and   
   5. Providing credentialing and privileging review of CDs in their Area.
2. Chief Executive Officer.  The SU Chief Executive Officer (CEO) or a designee is responsible for reviewing, recommending, and routing the credentialing and privileging recommendations of the SU Executive Committee of the Medical Staff (MEC) to the GB.  The CEO’s is the final recommendation prior to submitting an applicant’s file to the GB.
3. Headquarters Chief Medical Officer.  The IHS HQ CMO is the senior-level medical position that is responsible for:
   1. Overseeing medical and clinical operations for the Agency including credentialing and privileging of LPs at all Federal SUs within the Agency, through Area CMOs; and
   2. Approving updates to the SOP Manual, including the responsibilities listed in the High-Risk Credential Findings section below in this policy.
4. Chief of Service or Department Chief.  Where SUs have Chief(s) of Service or Department Chief(s), the Chief of Service or Department Chief may provide a discipline-specific review of an applicant.  They are responsible for reviewing applications for medical staff membership, determining the appropriateness of requested privileges, reviewing credentialing documentation, and evaluating current competency.  The Chief of Service or Department Chief is responsible for making recommendations for appointments and privileges to the Credentialing Committee (where applicable) or the MEC.
5. Clinical Director.  The CD is the LP responsible for the administration and supervision of clinical care at an IHS facility, usually as part of their position but sometimes by appointment depending on medical staff bylaws.  These could also be known as CMOs within a facility.  The CD or designee of each IHS health care facility is responsible for the following: 
   1. Ensuring that the credentials review process is consistent and is completed for every LP prior to providing patient care, including initial appointment and privileging, reappointment and privileging, or new clinical privileges; 
   2. Supervising the entire credentialing process including the credential review, verification, and/or renewal;
   3. Ensuring facility medical staff bylaws, rules and regulations, and credentialing policies are consistent with this policy and the SOP Manual;
   4. Maintaining an open line of communication with the Area CMO, Human Resources, the facility’s administration, contracting officer, and the MSP;
   5. Making recommendations regarding appointments and privileging actions to the CEO based on recommendations received from the MEC.  In the cases where the CD has or could be perceived to have a conflict of interest (e.g., familial relationship with LP under consideration; CD is under active investigation for allegations of discrimination, harassment, or retaliation by LP under consideration), then the Area CMO should take on the above responsibilities absent existing processes for conflicts of interest in the medical staff bylaws;
   6. Ensuring that the monitoring and surveillance of the professional competency and performance of those who provide patient care services with delineated clinical privileges is completed according to (where applicable) accrediting body standards, CMS CoPs, and facility medical staff bylaws and peer review policies and processes. This includes the initial (focused) professional practice evaluation for new privileges (LPs new to the facility, as well as current LPs requesting new privileges, and when a focused review is needed) or ongoing professional practice monitoring and evaluation throughout the entire time the LP is appointed and privileged at the facility;
   7. Notifying the MSP of potential hires and/or selections of LPs in a timely manner to allow for complete and accurate credentialing and privileging processes to occur prior to providing patient care;
   8. Ensuring that the IHS Exit Clinical Performance Summary is completed for each LP that separates from the facility and stored appropriately in the Software.   This responsibility may be designated to another staff member; and
   9. Ensuring credentialing and privileging requirements are reviewed through audits and internal controls that permits oversight of accurate and current LPs credentials and privileging aligning with accrediting body standards (where applicable), CMS CoPs (where applicable) and facility medical staff bylaws.
6. Executive Committee of the Medical Staff.  The composition of this medical staff committee should be specified in the facility’s medical staff bylaws. The MEC, or equivalent body, is responsible for reviewing each application for appointments and privileging.  The Executive Committee of the Medical Staff (MEC) evaluates current competency, determines appropriateness of requested privileges, and makes a recommendation through the CD (or designee) and the CEO (or designee) to the GB.  The MEC recommendation will incorporate the recommendations of the CD, Chief of Service or Department Chief (where applicable), and Credentialing Committee (where applicable).
7. Credentialing Committee(s).  This is an optional committee.  The membership requirements and duties must be defined in the facility’s medical staff bylaws. Generally, such a committee will be responsible for reviewing applications as assigned by another authority such as the MEC or CD. This committee’s recommendations are usually then forwarded to the MEC.
8. Governing Board/Governing Body.  The Governing Board/Governing Body (GB) receives recommendations from the MEC and CD (or designee) through the SU CEO (or designee) and the GB is the final authority for determination of medical staff membership and/or privileges.  In cases when high-risk credential findings are present, the GB must also receive an endorsement determination from an IHS HQ CMO-designated committee (See 3-1.3F).  In IHS, the GB usually includes the Area Director and others from the Area Office.  The GB provides authorization to appoint, continue, revise, discontinue, limit, or revoke some or all of the practitioner’s privileges and/or medical staff membership.  The GB Chair or designee is the final signatory for approval of credentialing documents on behalf of the GB.  The GB has the ultimate responsibility for the initial and ongoing oversight and delivery of health care rendered by LPs through the medical staff process.
9. Indian Health Service  Credentialing Coordinator.  The IHS HQ Credentialing Coordinator is responsible for supporting credentialing of LPs via standardized methods and a uniform system, developing and implementing internal control programs to manage credentialing standards and policy, maintaining centralized credentialing software system, promoting unification of MSP, and promoting standardized training and support resources for MSP.  The IHS HQ Credentialing Coordinator or designee shall biennially review, update, and maintain the credentialing and privileging policy and the SOP Manual with IHS MSP to harmonize alignment with industry best practices, accreditation standards, software updates, and other relevant considerations.
10. IHS Area Medical Service Professional (MSP).  The Area Medical Service Professional (MSP) role is to provide expert guidance and support to the IHS Area CMO and Service Unit MSPs in all aspects of credentialing and privileging operations.  The Area MSP is responsible for the following:
    1. Credentialing processes and software system guidance, training, and compliance to credentialing/privileging standardization including processes and software fields with the Service Unit MSPs.
    2. Responds to IHS HQ credentialing reports, audits, and investigation requests.
    3. Trains or assists the Service Units in providing training of new MSP of IHS credentialing policy, processes, and the proper and appropriate use and implementation of all current credentialing software components on credentialing and tracks Service Unit MSP training requirements identified in the SOP Manual.
11. Service Unit Medical Services Professional or Credentialist.  The MSP or Credentialist performs credentialing functions on behalf of the CD of the facility as it relates to this policy, the SOP Manual, Federal regulations related to credentialing and privileging, the facility’s accrediting organization and medical staff bylaws, which may include quality improvement, risk management, internal controls, audits, and regulatory compliance and management.  The MSP is responsible for the following: 
    1. Credentialing (initial appointments and reappointments) of all LP; initial and ongoing verifications; recording and maintaining accurate privileges; maintaining information data banks; reviewing compliance with applicable credentialing and privileging regulations (such as, prescribing authority and scope of practice for non-physician LP), facility medical staff bylaws, rules and regulations, applicable accrediting standards, HQ, Area, or SU policies; internal controls and audits; and facilitating communication between LP and the SU CD.
    2. Collecting, documenting and maintaining an accurate LPs credentialing and privileging database within the Software and supporting Software optimization, standardization, and systemization.
    3. Reviewing, analyzing, documenting, and presenting all information collected and discovered through the credentials review process and providing all information to the reviewers and approvers (Chief of Service, where applicable, Credentials Committee, where applicable, MEC, CD, CEO, GB) for consideration in their recommendations, denials, or approvals.
    4. Taking and providing documentation of all initial and ongoing IHS MSP training requirements to maintain competency and proficiency in their work to the Area MSP.  IHS MSP training requirements will be listed and maintained in the SOP Manual.

3-1.3 CREDENTIALS AND PRIVILEGES PROCEDURES

This section provides key policy guidance to understand and implement credentialing and privileging procedures effectively.  This framework aims to ensure that all procedures are aligned with overarching policies and are described in the SOP Manual.

1. Clinical Privileges.  The granting of privileges must reflect the current competence, character, training, experience, and judgement of the applicant as they relate to the staffing, facilities, and capabilities of the IHS directly operated facility or program.  This is done at the time of initial application or reapplication and at any time that modification of privileges is indicated or requested.  For facilities that have discipline-specific staff or consultants or a Credentials Committee, the review and recommendations will start with them. Otherwise, the recommendation of privileges should be made by the MEC or its equivalent (as defined in the medical staff bylaws) routed through the CD (or designee), and the CEO (or designee) to the GB for final determination of denial or approval of medical staff appointment and/or clinical privileges.
2. Credentials and Privileges Review.  All individuals who are eligible for membership on the medical staff and/or who request privileges must have a verified, documented, current review and approval of their professional education, training, licensing, current competence, and professional conduct.  Credentials verifications are from the primary source or designated equivalent source, and may rarely be from a secondary source (see SOP Manual for additional guidance) and provide documented and verified evidence of current competence, character, judgment, education, and training.  An endorsement determination from an IHS HQ CMO-designated committee is required if high-risk credential findings are present as outlined in the SOP Manual.
3. Data Sharing within the Indian Health Service.  The IHS will maximize data sharing between SUs to the full extent allowed by applicable laws, regulations, and terms of use.  This increases transparency and accountability in credentialing and thus improves patient safety.  Additionally, this  increases efficiency and decreases the burden of credentialing on the LPs and MSP.  The IHS will maintain a list of appropriate elements that can be shared and how to accomplish this in the SOP Manual.
4. Distant Site Telehealth/Telemedicine.  Distant site telemedicine LPs may be credentialed by proxy or by the full medical staff process as determined by the facility, this policy, and the SOP Manual. When credentialing by proxy is used, the MEC and the GB may use the credentialing and privileging information from the distant site to determine whether the distant site LPs should be granted clinical privileges at the IHS facility.  The GB must still make a determination to grant the distant site provider clinical privileges.  All other requirements for the granting of clinical privileges via a credentialing by proxy method must be met.  However, any LPs that practice onsite at the facility must be fully credentialed and privileged through the full medical staff process.  The full credentialing by proxy process and its requirements are further defined in the SOP Manual.
5. Exit Clinical Performance Summary.  When an LP leaves employment with the IHS, a summary of the LP’s resignation, competency, and conduct will be captured by the facility CD on the IHS Exit Clinical Performance Summary and stored in the Software.  The CD may designate another individual who is a peer to complete this but the CD maintains the responsibility to ensure completion.  In the case that a CD is unavailable, the Area CMO should complete the summary.  The Exit Clinical Performance Summary does not replace any reporting requirements that may exist in the case of negative findings, including, but not limited to:  
   National Practitioner Data Bank (NPDB), licensing organizations, law enforcement, child protective services, Department of Health and Human Services (HHS) Office of the Inspector General (OIG), internal IHS reporting requirements, or adverse event reporting.
6. High-Risk Credential Findings.  The IHS HQ CMO or designee has the authority and responsibility to create, update, and maintain the criteria for high-risk credential findings, the timeline for response, and to ensure these are published and maintained in the SOP Manual to inform the MEC and GB in their recommendations and final determinations of clinical privilege(s) requests.  High-risk credential findings can cover any aspect of an LP’s application, including but not limited to education, training, licensing, experience, professionalism, and conduct.
   
   The IHS HQ CMO has the authority and responsibility to designate and define the committee or process by which to address endorsement determination requests for high-risk credential findings to ensure appropriate evaluation and awareness.  This committee will be known as the Agency Clinical Credentialing Committee (ACCC).  Any LP with high-risk credential findings requires review by the ACCC.  Any evaluation for endorsement within this committee must have a minimum of three LP members with equal or greater credentials, of which at least one should also represent the same specialty, whenever feasible, as the LP for whom an endorsement determination is being sought.  Endorsement determinations may only be issued by this committee after review and majority approval and must be provided prior to the final GB action.
7. Local Policy Alignment.  This policy establishes minimum standards, procedures, and requirements for credentialing and privileging LPs in all IHS facilities.  Each IHS facility will ensure local policies, procedures, medical staff bylaws, and governance documents for credentialing and privileging align with this policy, the most current SOP Manual, and the facility’s accrediting organization standards.  The IHS Areas and Service Units (SUs) may have more restrictive policies, medical staff bylaws, standards, and procedures, but shall not adopt any policies, medical staff bylaws, standards, or procedures that conflict with this policy or the SOP Manual.  For proper compliance and consistency, please refer to the most current SOP Manual kept on the Office of Quality, Division of Quality Assurance, Patient Safety, & Clinical Risk Management page, in the Credentialing Program section within the Education and Training section.  Additionally, any IHS hospitals, ambulatory centers, and clinics that bill Medicare for services shall maintain credentialing and privileging policies and procedures consistent and in accordance with CMS CoPs.  All actions taken on an application relevant to credentialing and privileging to grant, refuse, renew, revoke, suspend, or modify must be made in accordance with this policy, the SOP Manual, and applicable laws.
8. Policy Review.  The IHS HQ Credentialing Coordinator or designee shall biennially review, update, and maintain this policy and the SOP Manual with IHS MSPs to harmonize alignment with industry best practices, accreditation standards, software updates, and other relevant considerations.  The IHS HQ CMO or designee has the authority and responsibility to approve updates to the SOP Manual.  This policy remains in effect as-is during and/or in the absence of biennial reviews.  Biennial reviews will be documented in the Office of Quality, Division of Quality Assurance, Patient Safety, and Clinical Risk Management, Credentialing Program.
9. Practitioners.  All LPs (e.g., Federal employees, contractors, volunteers) who are authorized under their license and the facility’s medical staff bylaws to practice shall be appropriately screened, credentialed, and privileged by the facility’s medical staff leadership and the GB in accordance with this policy and the SOP Manual, post tentative job offer and prior to providing care at any IHS facility.
   
   All LPs, including applicants to the medical staff, must promptly report to the CD of the IHS facility any changes in the information provided on their application including, but not limited to:  changes in licensure status for any of the states in which they hold licenses; Drug Enforcement Administration (DEA) or state authorization to prescribe controlled substances; changes in medical staff appointment or clinical privileges at another hospital or health care facility because of issues related to clinical competency or professional misconduct; an arrest, charge, indictment, conviction, or a plea of guilty or no contest in any criminal matter (other than a misdemeanor traffic citation), such as driving under the influence (“DUI”), failure to pay Federal or state taxes, etc.; exclusion or preclusion from participation in Medicare/Medicaid or any other Federal health care program or the imposition of any sanctions; any changes in ability to safely and competently exercise clinical privileges or perform the duties and responsibilities of appointment.  Licensed Practitioners shall report such changes when they occur and shall not wait until the next reappointment period to report new information or updates.
10. Professional Conduct.  Professional conduct for each LP shall be governed by Federal law and policy, including but not limited to the Standards of Ethical Conduct for Employees of the Executive Branch (5 C.F.R. Part 2635), the HHS Residual Standards of Conduct (45 C.F.R. Part 73), and the facility’s Code of Conduct and, to the extent consistent with Federal law and policy, the ethical and moral codes of the appropriate representative professional organizations (e.g.’ American Medical Association for physicians).
11. Protected Materials.  LPs may not access their own verifications and/or documents received for their credentialing and privileging file to include their own peer references, affiliation verifications, IHS Exit Clinical Performance Summary, or any other protected materials within their own credentialing file, unless the IHS Director has decided to release the records in accordance with 25 U.S.C. § 1675.  LPs may be able to obtain information from their employment or contract files or other sources within IHS in accordance with Federal law. Protected materials are further defined in the SOP Manual.
12. Software.  All IHS Federal facilities shall use the Software for all credentialing and privileging of all LPs (e.g., Federal employees, contractors, volunteers) and fully optimize its use to support the entire process of credentialing and privileging from application to approval.  The credentialing and privileging process and records (application to approval) shall be maintained in the Software for reference and to ensure proper compliance, consistency, and implementation.  Records originally collected and maintained outside of the credentialing and privileging process, for example by Human Resources in the case of an applicant for employment, or the Contract Office in the case of a contractor, must be separately maintained by those offices, consistent with applicable records retention policies.  All IHS Federal facilities shall follow the Agency’s standardization and systemization of provider credentialing and privileging in the current Software. During any Software disruptions, the Area and SU shall maintain ongoing verifications of credentials by verifying outside of the Software directly with the primary source, designated equivalent source, or secondary, if allowed.  Once downtime is resolved, any credentialing or privileging actions (e.g., verifications, approvals) taken during downtime must be promptly documented in the Software.
13. Temporary Privileges.  Only LPs with a complete, clean file (defined in the SOP Manual) may be considered for temporary privileges in an IHS facility.  Temporary privileges shall be in accordance with the facility’s accrediting body standard requirements, facility medical staff bylaws and policies, this Agency policy, and the SOP Manual.
14. Background Investigation Pre-Clearance.  Prior to attending patients, all LPs (IHS-employed, contractors, or volunteers) must have approved credentials and privileges by the Area/Facility GB and background pre-clearance from an IHS Personnel Security Representative before an entry-on-duty date is established.  It is the joint responsibility of the IHS hiring (selecting) official and the Office of Human Resources to ensure both credentialing and privileging have been approved and background pre-clearance is completed.
    
    For additional guidance, please refer to Indian Health Manual (IHM), Part 5, Chapter 30, Homeland Security Presidential Directive – 12; Part 11, Chapter 2, Protecting Children from Sexual Abuse by Health Care Providers; Part 3, Chapter 23,Ethical And Professional Conduct Of Health Care Providers; Special General Memorandum Number 21-02; Special General Memorandum Number  23-02, and their updates.

3-1.4 MEDICAL STAFF APPOINTMENT STATUSES

There are several different statuses of medical staff membership that can be granted by a facility’s GB and at a minimum the following statuses should be defined in the facility’s medical staff bylaws: 

1. Active
2. Associate (Consultant/Courtesy)
3. Honorary

3-1.5 MEDICAL STAFF CREDENTIALS

All LP applicants who are seeking medical staff membership and/or clinical privileges at an IHS directly-operated facility or program are subject to this policy, the facility’s accrediting organization standards, the facility’s medical staff bylaws, credentialing and privileging regulations, if applicable, other IHS LP policies, and the credential documentation and review process.  Applications may be obtained through the facility’s medical staff office.  All LP applicants shall complete the Agency’s approved medical staff application(s) relevant to the scope of their license, registration, certification, or otherwise recognized medical professional capacity.  All applicants and members of the medical staff must have a complete and comprehensive credentials review and be granted clinical privileges before delivering any health care services to any patient in an IHS directly-operated facility or program.

The granting of membership to medical staff shall confer no particular clinical privileges. Clinical privileges shall be requested and granted only in accordance with privilege criteria and current competency, and with facility-supported procedures.

1. Verification of Documentation.  A complete and comprehensive credentials review process shall, at a minimum, require collection, analysis, and verification of the following elements.  Electronic signatures are acceptable on all credentialing forms that require signature.  Additional information on verification, documentation, and review of the following verification requirements are included in the SOP Manual.
   1. Proof of Identity. 
   2. Professional Education. 
   3. Post-Graduate Training (where applicable). 
   4. Experience. 
   5. Time Gaps. 
   6. Board Certification and Professional Affiliations (where applicable).
   7. Licensure. 
   8. DEA Registration and state Controlled Dangerous Substance Certifications (where applicable).   
   9. Current Competency. 
   10. Signed IHS Practitioner Acknowledgement and Release Form
   11. Continuing Medical Education (CME) or Continuing Professional Education (CPE).   
   12. Professional Peer References.  
   13. National Practitioner Data Bank (NPDB) Query.   
   14. Life Support Certificates (where applicable). 
   15. Immunizations (where applicable and consistent with Federal law).  
       See the SOP Manual for the most current list of immunizations required to be received for credentialing.
   16. Current Liability Insurance.
   17. Professional Liability Claims, Suits, and/or Judgments.  Regarding previous or pending professional liability claims, suits, and/or judgments made against them.
   18. Sanctions Disclosure or Current Investigations.  Sanctions involving the Medicare or Medicaid programs or any other Federal or state health care program as well as any HHS OIG past or current administrative, criminal, or civil investigation. 
   19. Denials, Restrictions, and Resignations.  Regarding previous or pending medical staff applications and/or clinical privileges.  
   20. Reduction, Suspension, Revocation, Voluntary or Involuntary Relinquishment, or Non-renewal of Clinical Privileges.  Regarding previous or pending reduction; suspension, revocation, voluntary or involuntary relinquishment; or non-renewal of clinical privileges.
   21. Current Illegal Use of Drugs.  Regarding the current illegal use of legal or illegal drugs.
   22. Loss, Suspension, Restriction, Denial of Professional License or Professional Society Membership.  Regarding information on previous or pending loss, suspension, restriction, denial, or whether a voluntary or involuntary relinquishment of professional licensure or professional society membership.
   23. Convictions.  Regarding information and documentation relating to convictions, with the exception of minor traffic violations, including any convictions related to DUI, failure to pay Federal or state taxes, etc.

3-1.6 IMPAIRED PROVIDERS 

The medical staff and facility GB have an obligation to protect patients, its members, and other persons present in the facility from harm.  Consistent with applicable Federal law, each Area must establish a process to:  identify and report when an LP’s impairment is suspected; provide appropriate options for investigating and responding to a suspected impairment; and ensure that any mandated reporting requirements are followed. To ensure compliance with applicable laws, the process must include consultation and coordination with the Area Office of Human Resources, Office of Equal Employment Opportunity, and/or Office of the General Counsel, as applicable.

3-1.7 MEDICAL STAFF CREDENTIALS FILES  

Medical staff credentials records or files, which include privileging records, are one type of IHS medical quality assurance record as defined at 25 U.S.C. § 1675.  The information in the credentials records/files may be derived from separate employment or contractual files and data.  However, the medical staff credentials records/files—including copies of records derived from any employment and/or contract records/files—are distinct and separate from the credentialing records/files, and are utilized for the sole purpose of maintaining information collected for, created during, or related to, the review of granting of medical staff membership and/or clinical privileges for LPs.  Peer review and other types of IHS medical quality assurance records are to be maintained separately from the medical staff credentialing and privileging records/files and stored according to Area or SU peer review policies.  However, a Peer Review Summary that confirms an LP is an active participant in peer review (e.g., focused or ongoing professional practice evaluations) and summarizes their performance is acceptable to store in the Software. Patient names, chart numbers, names of peers providing reviews or recommendations, discussion, deliberations, opinions, or findings related to the peer review should not be included in the Peer Review Summary documentation in the Software.

1. Records Management. 
   1. The Records Management Program for medical staff credentials files is set forth in the IHM, Part 5 Chapter 15, “Records Management Program” and the Request for Records Disposition Authority (DAA-0513-2018-0002). Medical staff credential files are identified as media-neutral (paper and/or electronic).
   2. Access to the medical staff credentials files within the Agency is limited to authorized personnel who need the files for the performance of their official duties as established by 25 U.S.C. § 1675.
   3. Medical staff credentials files are privileged and confidential pursuant to Federal law 25 U.S.C. § 1675.  Medical credential and privileging files can only be released outside of the Agency for purposes authorized under Federal law.
2. Systems File Managers.  The Area Director and the CEO of each facility are designated as the “Systems File Managers” for the medical staff credentials and privileging records.  Systems File Managers will ensure that:
   1. Medical staff credentials records remain confidential and are secured at all times;
   2. Disclosures outside of the Agency must be logged for accountability on the IHS-505 form, or its electronic equivalent, including identifying information about the request for disclosure and the recipient of the information; and
   3. Role-based access controls are in place and maintained by personnel who have an official need to read/write/edit/delete.
3. Records Retention.  All medical staff credentials files and related documents shall be maintained in accordance with the effective IHS Records Disposition Schedule set forth in the IHM and Request for Records Disposition Authority (DAA-0513-2018-0002 and the Privacy Act System of Records, Memorandum No. 09-17-0003 and its amendments.
4. Privacy Act Considerations.  All medical staff credentials files and related documents are to be maintained in conformance with the IHS Privacy Act system of records.  These requirements adhere to the rules, laws, and regulations of the Privacy Act of 1974, Title 5 U.S.C. §552a, as amended, and the “Health Insurance Portability and Accountability Act of 1996,” Public Law No. 104-191, as amended.  Based on the specifications outlined in the September 9, 2009, and October 2, 2009, and May 23, 2023, Federal Register Notices, medical staff credentials files must maintain, at a minimum, the data that follows:
   1. The name and location of the system.
   2. The categories of individuals on whom records are maintained in the system.
   3. The categories of records maintained in the system; each routine use of the records contained in the system, including the categories of users and the purpose of such use. 
   4. The policies and practices of the IHS regarding storage, retrievability, access controls, retention, and disposal of records.
   5. The title and business address of the IHS official responsible for the system of records.
   6. The IHS procedures whereby individuals can be notified at their request if the system of records contains a record pertaining to them.
   7. The IHS procedures whereby individuals can be notified at their request, how to access any record pertaining to them that may be contained in the system of records, and how they can contest information in their record.
   8. The categories of sources of records in the system.