PWS.docx

TMSU/QNBMHCF | CRNA PERFORMANCE WORK STATEMENT

CRNA Performance Work Statement Quentin N. Burdick Memorial Health Care Facility 1 General Information

1.1 Purpose and scope

The Contractor shall provide non-personal Certified Registered Nurse Anesthetist (CRNA) services at Quentin N. Burdick Memorial Health Care Facility, Belcourt, North Dakota, an Indian Health Service (IHS) facility. Services support patients of all ages with medical, surgical, pediatric, geriatric, gynecological, and related anesthesia needs, within approved privileges and available facility resources. The supplied requirement provides for up to two CRNAs; the program must confirm the monthly coverage quantity in section 1.4.

The Contractor shall provide all personnel, supervision, supplies, equipment, transportation, and other items necessary to perform this PWS, except Government-furnished items identified in section 2. Providers are accountable to the Contractor. The Government may evaluate professional and administrative service quality; contract administration shall not direct individual medical judgments. Clinical services remain subject to applicable law, facility bylaws, policies, and approved privileges.

1.2 Contract type and monthly pricing

The Government will award a firm-fixed-price, non-personal services contract. The unit of issue for pricing and payment shall be Month (MO). The firm-fixed monthly price shall cover the required scheduled services, on-call and call-back coverage, orientation and replacement coverage, contract management, travel, lodging, per diem, labor, fringe benefits, applicable taxes, liability insurance, and other costs necessary to perform this PWS. These costs shall not be separately billed unless expressly authorized by the contract.

1.3 Period and place of performance

The period of performance shall be stated in the purchase or task order. Services shall be performed at Quentin N. Burdick Memorial Health Care Facility, Belcourt, North Dakota, as scheduled with the Clinical Director or designated representative. The program and Contracting Officer shall confirm the start date, base and option periods, and priced monthly quantities before solicitation.

1.4 Schedule and coverage

The usual on-site workday is Monday through Friday, 7:00 a.m. to 3:30 p.m., except Federal holidays and Government-directed facility closures. The Contractor shall maintain the workforce necessary to perform the required coverage and support continuity of care. Providers shall schedule and perform procedures as appropriate.

The contract provider will cover 14 days at a time (Can be one provider for 14 continuous days or two providers 7 days each) On call from home Saturday/Sunday and M-F 12am – 7am and 3:30pm to 11:59pm The Contractor shall provide required call-back services, including weeknights, weekends, and holidays, as stated in the order schedule. The supplied clinical task language describes a call assignment as a 24-hour period beginning at 7:00 a.m. and ending at 7:00 a.m. the next day. The program shall reconcile this assignment period with the on-site and home-call schedule above and establish response and backup requirements.

On-call coverage for Federal holidays shall be included as required by the order schedule. The supplied holiday list includes New Year’s Day, Martin Luther King Jr.’s Birthday, Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Indigenous Day, Veterans Day, Thanksgiving Day, and Christmas Day.

Program confirmation required: State the number and sequence of coverage days included in each monthly price. The fourteen-day statement identifies how an assignment may be divided between providers; it does not establish the frequency of those assignments.

1.5 Contract administration and contacts

Only the Contracting Officer may change the contract’s scope, price, performance period, or other terms, or bind the Government. No other Government employee or representative may authorize additional funding, services beyond contractual coverage, or a change to the contract. The Contracting Officer’s Representative (COR) shall be designated in writing and may monitor technical performance, inspect services, coordinate Government resources and access, communicate technical requirements, and report deficiencies within the limits of that designation.

The Contractor shall attend post-award conferences and periodic performance meetings requested by the Government at no additional cost. The parties shall discuss performance, deficiencies, and corrective actions.

The supplied PWS identifies the following Government contacts, subject to confirmation: Clinical Director — Dr. Gilbert Falcon or Dr. Shyleen Hall; Credentialing Coordinator — Jennilee Blue; COR — Yvette Wallette. Government contacts are not Contractor key personnel.

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m., Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.6 Quality control and assurance

The Contractor shall maintain a quality control program that identifies, prevents, and corrects defective services and prevents recurrence. Submit the Quality Control Plan (QCP) within 30 days after award, or with the proposal if the solicitation makes it an evaluation factor. Submit three copies of QCP changes to the Contracting Officer and COR within five working days; obtain written Contracting Officer acceptance before implementing changes to the accepted system.

The Government shall evaluate performance under the Quality Assurance Surveillance Plan (QASP) and Technical Exhibit 1. The final QASP shall identify surveillance methods, frequency, standards, and acceptable performance thresholds. The proposed exhibit requires program approval before solicitation.

1.7 Contractor identification

All contract personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed. The contractor personnel will be required to obtain and wear badges in the performance of this service.

1.8 Data rights and organizational conflicts

The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent Organizational Conflict of Interests (OCI) as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

2 Government Furnished Items The Government shall provide, without cost to the Contractor, personnel for orientation and guidance, workspace, facility utilities, access to available computers, telephones, scanners, fax machines and printers, and applicable standard operating procedures and policies. The Contractor shall conserve utilities and safeguard Government property. The program shall confirm that clinical facilities, equipment, supplies, and support services are sufficient for the required anesthesia scope; this draft does not add equipment to the supplied Government-furnished commitment.

3 Provider Qualifications and Onboarding

3.1 Qualifications

Each provider shall maintain the nursing licensure, CRNA certification, and clinical privileges required by applicable law and facility credentialing requirements throughout performance. The supplied PWS requires a current, unrestricted nursing license from any of the 50 United States or the Commonwealth of Puerto Rico and registration with the applicable professional certification board and state licensing authority. The program shall confirm the exact RN/APRN and national certification requirements before solicitation.

Possess current (BLS) Basic Life Support certification, (PALS) Pediatric Advanced Life Support, (NRP) Neonatal Resuscitation Program, and (ACLS) Advanced Cardiac Life Support is required.

Not have any work or health restrictions, which interfere with the performance of general medical services.

Have actively provided Anesthesia within the past year.

Have skill and knowledge in providing medical care with full consideration of the mental, emotional, physical, and cultural factors involved, such that he/she can relate constructively to patients from the Native American community.

Ability to work with patients, the public, and hospital staff.

Each provider shall have completed an approved nurse anesthesia certification program and possess the skills required for the anesthesia duties in section 4, including consultation, diagnostic assessment, routine and major/minor surgical anesthesia, and emergency services. Providers shall work within approved privileges and applicable prescribing and ordering authority.

3.2 Credential verification and references

The Contractor shall promptly provide information requested for credentialing and privileging and shall investigate, verify, retain, and submit provider qualifications, curriculum vitae, performance history, and disciplinary information to the facility Clinical Director and Credentialing Coordinator.

Verify through the National Nursing database all active, inactive, and lapsed licenses that are held, or have been held, by nurses who would provide services in I.H.S. hospitals and clinics under this contract.

Inform I.H.S. of the status of all licenses for each nurse who would provide services under this contract in I.H.S. hospitals and clinics, including all reasons for each inactive or lapsed license.

Obtain at least three letters of reference from health care providers whom have knowledge of the applicant’s clinical practice skills within the past six months. The Contractor shall investigate, verify, maintain, and submit documentation of curriculum vitae for each provider proposed to provide services at the Belcourt Indian Health Service Hospital. Such documentation must show compliance with provisions shown under section 3.1.

Provide all information regarding performance and disciplinary actions that is collected on a provider who would be placed under this contract to the receiving I.H.S. facility Clinical Director. This includes all information that is collected and compiled on such providers at the time of initial hire by the Contractor, and/or information that is reported during periods that the Contractor is an agent of such Certified Registered Nurse Anesthetist (CRNA) for placement under this contract.

Certify that all information obtained on Certified Registered Nurse Anesthetist (CRNA) whom they would assign to I.H.S. hospitals and clinics has been reviewed and verified by the Contractor. This certification must include a statement that the Contractor has found no reason to reject the Contracted Certified Registered Nurse Anesthetist (CRNA) application. The names of the contacts, their titles, telephone numbers, and dates of representative collecting and reviewing such information must be recorded in writing and made available to the I.H.S. by the Contractor.

Reference sources shall include a previous supervisor at the hospital where the provider holds or last provided care and may include a residency director for training within the previous two years, a professional supervisor or department chair, and a professional colleague. The supplied PWS also requires references to have worked with the provider within the last year. The program shall reconcile this requirement with the six-month clinical-knowledge criterion above.

Submit the required credentialing information 10–14 days before the proposed report date. Each provider shall complete the facility Application for Appointment to the Medical Staff. Credential verification, required medical staff approval, Clinical Director approval, and Governing Body approval of clinical privileges must be completed before the provider delivers patient care. No delayed-documentation exception authorizes care before these approvals.

Candidates with prior Advanced Nursing Licensure actions are not eligible for temporary privileges. The process of granting of privileges by the facility Governing Body may take up to 3 months.

3.3 Loss of qualifications and replacement

If a Contractor provider’s privileges are revoked at any time during the term of the contract, the Contractor shall remove the provider from providing services to the Indian Health Service under the terms and conditions of this contract. The Contractor shall provide a credentialed provider(s) to complete the removed provider(s) placement assignments. If at any time it is determined that improper or falsified credentials have been submitted or any of the contractor provider(s) Licensure documents expire or be revoked, privileges for the provider to which they pertain will be revoked, initially by verbal notification, followed by written notification to the Contractor. The replacement provider(s) travel costs to the service unit shall be the responsibility of the Contractor.

Replacement providers are subject to the same qualification, credentialing, background, health, and privileging requirements before providing patient care. Replacement travel costs are included in the monthly price.

3.4 Background investigations and security

The Contracted Certified Registered Nurse Anesthetist’s (CRNA’s) are subject to a background investigation and shall comply with Section 231 of the Crime Control Act of 1990, P.L. 101-647; and the Indian Child Protection and Family Violence Prevention Act, P.L. 101-630. In addition, the nurse shall also comply with the Privacy Act of 1974 and the HIPAA Act of 1996. Failure to comply with these statutes will result in immediate removal.

Contractor personnel performing work under this contract, which involve regular contact with, or control over, Indian children, are subject to a character investigation in accordance with the “Indian Child Protection and Family Violence Prevention Act” P.L. 101-630. The Indian Health Service Personnel Office will conduct these investigations following award of a contract unless in the judgment of the Contracting Officer, in consultation with the Personnel Officer, investigation may be waived based on prior investigations on file. Until the character investigation has been completed and the Contracting Officer notified, such individual shall not have unsupervised contact with Indian children.

The Contracting Officer has the authority to temporarily waive the character investigation of a contractor. The “Agreement to a Temporary Waiver of Character Investigation” (See Attachment B) authorizes an agency to hire a contractor prior to the completion of a background check provided that at all times the contractor is within the sight and under the supervision of a government employee who has successfully completed the National Agency Check with written Inquiries (NACI).

This level of security is required, and must be maintained for the life of the contract.

Contracting and personnel review required: Validate the current investigation process, waiver authority, terminology, and referenced Attachment B before solicitation. Attachment B was not included in the supplied document. Any background-investigation accommodation does not waive credentialing or privileging requirements.

3.5 Employee Health requirements

Before placement, the Contractor shall submit provider onboarding health information and documentation required by the facility’s Employee Health program. Documentation shall address hepatitis B, measles/mumps/rubella, varicella, tetanus/diphtheria/pertussis, influenza, and tuberculosis, as applicable. Employee Health shall determine acceptable evidence of immunity, testing, vaccination, approved declinations or exemptions, and fitness for the assigned duties under applicable requirements.

Hepatitis B vaccination and any indicated serologic follow-up or revaccination shall follow the applicable product schedule and current CDC guidance for health care personnel. Do not apply a single vaccine dose series to every product. Occupational exposures and nonresponse shall be managed under the facility Infection Control Plan and applicable guidance.

Baseline tuberculosis screening shall include the applicable risk assessment, symptom evaluation, and testing or documented prior results under current CDC guidance and applicable local requirements. Personnel with a documented prior positive test shall be evaluated under the appropriate prior-positive pathway. A prior normal chest X-ray is not subject to a blanket twelve-month expiration under this draft; Employee Health shall determine whether additional imaging is indicated.

Employee Health review required: Supply the approved facility policy, its version, documentation standards, and submission instructions before solicitation. The consolidated wording replaces the legacy detailed vaccine and TB algorithms; it does not establish that Employee Health has approved revised policy.

Medical information shall be kept in separate confidential medical records and transmitted through authorized secure channels. Failure to provide required onboarding information may prevent placement, consistent with applicable facility requirements.

3.6 Medical liability insurance

The Contractor will be solely liable for and expressly agrees to indemnify the Government with respect to any professional liability producing acts or omissions by it or its employees or agents. The Contractor will maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than One (1) Million Dollars per occurrence and $3,000,000.00 aggregate.

Before award, the apparently successful offeror shall furnish evidence of insurability, or provide such evidence when requested by the Contracting Officer.

Liability insurance may be on either an occurrence basis or on claims made basis. If the policy is on claims made basis, an extended reporting endorsement (tail) for a period of not less than three (3) years after the end of the contract term must also be provided.

A CERTIFICATE OF INSURANCE EVIDENCING THE REQUIRED COVERAGE WILL BE PROVIDED TO THE CONTRACTING OFFICER PRIOR TO THE COMMENCEMENT OF SERVICES UNDER THIS CONTRACT. If the insurance is on a claims made basis and evidence of an extended reporting endorsement (tail) is not provided prior to the commencement of services, evidence of such endorsement will be provided to the Contracting Officer prior to the expiration of this contract. Final payment under this contract will be withheld until evidence of the extended reporting endorsement (tail) is provided to the Contracting Officer.

The policies evidencing required insurance will also contain an endorsement to the effect that any cancellation or material change adversely affecting the Government's interest will not be effective until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer. If during the performance period of the contract the Contractor changes insurance providers, the Contractor will provide evidence that the Government will be indemnified to the limits specified in this Performance Work Statement. This will be for the entire period of the contract, either under the new policy, or a combination of old and new policies.

The contractor shall insert the substance of this clause, including this paragraph, in all subcontracts under this contract for health care services and will require such subcontractors to provide evidence of and maintain insurance in accordance with this clause.

At least 5 days before the commencement of work by any subcontractor, the contractor will furnish to the contracting officer evidence of such insurance.

The Contractor shall ensure that subcontracts for health care services contain the requirements of FAR 52.237-7, including medical liability insurance and facility professional credentialing requirements. Insurance shall meet the Contracting Officer’s requirements and shall not be less than the amount normally prevailing in the local community for the specialty concerned.

4 Clinical Services and Performance All services below are subject to the provider’s verified qualifications, approved clinical privileges, applicable law, and facility bylaws and policies. The program shall confirm the clinical scope, oversight arrangements, and required age groups before solicitation.

4.1 Anesthesia care

The Contract Anesthesia Provider shall provide anesthesia services for patients who require care for complex and severe illness or problems and with immediate or serious threat to life. Services shall include outpatient, in-patient, and emergency services. This category requires completion of an approved certification program for Nurse Anesthetists.

Conduct clinical examinations of patients assigned to his/her service.

Pre-operative work-up with a consultative note in the outpatient section of the patient chart and admission note.

Consult with other physicians on surgical problems.

Induce anesthesia for major and minor surgical operations on the integumentary, respiratory, gastrointestinal, genitourinary, and skeletal systems.

The provider shall administer regional and local anesthesia and provide postoperative care and follow-up, including rounds and other visits as necessary and indicated. Coordination with surgeons and other clinicians shall follow applicable facility policies and approved privileges. Contractual oversight shall follow section 1.5. The program shall confirm the required clinical supervision or collaboration arrangement; this draft does not independently establish one.

Complete required operative reports within 24 hours after the procedure. Complete discharge summaries and other outstanding records before departure, for documentation within the provider’s assigned responsibilities and privileges. The program shall confirm which reports and summaries are CRNA deliverables.

Providers shall participate in scheduled on-call anesthesia services and be capable of emergent and nonemergent procedures within approved privileges. Section 1.4 governs the proposed schedule, subject to program clarification.

Pre-operative and post-operative anesthesia evaluations will be made and properly recorded in the patient’s medical record as required by the Joint Commission on Accreditation of Healthcare Organizations relative to the choice of anesthesia and the surgical or obstetrical procedure anticipated. The pre-operative medications are administered, except in extreme emergency situations where the performance and recording of the evaluation would place the patient’s life in danger.

The anesthesia provider must have the skills necessary to induce anesthesia, maintain anesthesia at the required levels, and continue life support functions and include but not be limited to endotracheal intubations and extubating, insertion of arterial catheters, performing arterial punctures, identification and management of emergency anesthesia situations such as malignant hypothermia, supervision of ventilator assistance both by respirator and ventilator and cardiopulmonary resuscitation.

The anesthesia provider must recognize and take appropriate corrective action including the request for consultation when necessary for abnormal patient responses to anesthesia or any adjunctive medications or observation and resuscitative care until the patient has regained control of his/her vital functions.

4.2 Clinical conduct and quality

Providers shall not perform services while impaired by alcohol, drugs, or other incapacitating agents. Providers shall counsel and educate patients, families, the community, and medical staff about care within their clinical role and approved scope.

The Contract provider shall assess operative services care to ensure its quality. The Contract provider will participate in a continual process of self-evaluation and strive for excellence in anesthesia services.

The Contract provider shall participate in medical staff functions, such as medical program reviews, performance improvement activities and organizational functions, including attending committee meetings and accepting committee assignments. The Contract provider shall meet all applicable Joint Commission standards during the performance of the contract.

The Contract provider may be required to provide formal or informal continuing education to members of the Service Unit Medical Staff and other Service Unit staff. The training shall be in clinical intervention.

Providers shall comply with facility infection control and safety procedures, applicable Centers for Medicare & Medicaid Services standards, and patient rights, including personal dignity.

4.3 Formulary and referrals

Authorized prescribing and ordering shall remain within applicable law, the provider’s approved privileges, and facility policies. Providers shall follow the IHS formulary and pharmacy procedures. IHS pharmacy services shall provide applicable generic-substitution instructions. The Service Unit Pharmacy and Therapeutics Committee must approve nonformulary drugs.

Referrals – all referrals shall be done utilizing the Purchased Referred Care (PRC) referral form. The Purchased Referred Care committee utilizing C.H.S. guidelines will review these referrals.

4.4 Records and reporting

Providers shall create and maintain timely, accurate, legible, complete, and signed patient records in the Electronic Health Record under IHS and facility requirements. Documentation shall reflect the care provided and remain subject to IHS control. The Government shall provide orientation to the Electronic Health Record upon arrival. Confidentiality and data handling requirements are addressed in section 5 and Appendix A.

The Contracted Certified Registered Nurse Anesthetist (CRNA) shall provide a monthly progress report to the Quentin Burdick Memorial Healthcare Facility Indian Health Service Contracting Officer on the 6th of each month.

5 Security Privacy and Applicable Policies

5.1 Physical security and key control

The Contractor shall safeguard Government equipment, information, and property. At the close of each work period, Government facilities, equipment, and materials shall be secured.

The Contractor shall establish and implement methods of making sure all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized persons. NOTE: All references to keys include key cards. No keys issued to the Contractor by the Government shall be duplicated. The Contractor shall develop procedures covering key control that shall be included in the Quality Control Plan. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas. The Contractor shall immediately report any occurrences of lost or duplicate keys/key cards to the Contracting Officer.

In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

5.2 Confidentiality and policies

The Contractor and providers shall comply with applicable IHS, facility, CMS, HIPAA, OSHA, and other Federal and State requirements, including applicable medical staff bylaws and clinical policies. The supplied Privacy Act notification and Business Associate Agreement provisions are retained in Appendix A. Privacy and contracting officials shall confirm their applicability and approve the final agreement text.

5.3 Abbreviations

CO — Contracting Officer; COR — Contracting Officer’s Representative; CRNA — Certified Registered Nurse Anesthetist; IHS — Indian Health Service; IPP — Invoice Processing Platform; MO — Month; PWS — Performance Work Statement; QASP — Quality Assurance Surveillance Plan; QCP — Quality Control Plan; UEI — Unique Entity ID. Clinical certifications are identified in section 3.1.

6 Monthly Payment and Deliverables

6.1 Payment basis and acceptance

Payment shall be based on the firm-fixed monthly price for the coverage and services required by the contract and accepted by the Government. The Government reserves the right to reject unsatisfactory services under the contract’s inspection and acceptance terms. The Contractor shall submit coverage records or timesheets for Government review and verification; those records shall not establish an hourly basis for payment.

The Contractor shall submit one invoice for each completed service month in accordance with the order and Technical Exhibit 2. Only the Contracting Officer may approve a contractual price or scope change. The COR or designated clinical reviewer verifies performance within delegated authority.

Contracting determination required: Specify the method for partial months, missed coverage, substitutions, and Government-directed closures in the final contract. This draft does not establish a proration formula, deduction schedule, or automatic closure payment entitlement.

6.2 Invoice submission and contents

Submit invoices electronically through the Department of the Treasury Invoice Processing Platform (IPP) or successor system identified in the contract, unless an applicable exception or written Contracting Officer authorization permits an alternative. Follow the contract’s implementation of HHSAR 352.232-71.

Each invoice shall identify the Contractor’s legal name, address, contact information, UEI, contract/order number, invoice number and date, service month and dates, applicable line item, description of services, quantity in months, unit of issue MO, firm-fixed monthly unit price, and amount due, together with required performance-verification documentation. Provide taxpayer and banking information only through authorized payment-registration or other approved secure procedures rather than routine invoice copies.

6.3 Deliverables and workload

Technical Exhibit 1 presents proposed performance standards for program approval. Technical Exhibit 2 identifies deliverables and routing. Technical Exhibit 3 retains the supplied workload estimates solely for planning; it does not establish hourly billing or a monthly coverage quantity.

Technical Exhibit 1 Performance Requirements Proposed summary for program approval. Clinical quality thresholds are retained in substance; the program shall confirm measurable criteria and surveillance frequency in the final QASP. References correspond to this revised PWS.

Coverage and care Sections 1.4 and 4

Qualifications and privileges Section 3

Documentation Section 4.4

Clinical quality and safety Section 4.2

Customer concerns Section 4.2

Technical Exhibit 2 Deliverables Submission deadlines and recipients identified as requiring confirmation must be completed before solicitation. The monthly invoice method below replaces conflicting mailed and emailed invoice instructions.

Monthly invoice Section 6.2

Coverage record or timesheet Section 6.1

Credentialing package Section 3.2

Liability insurance Section 3.6

Employee Health documentation Section 3.5

Quality Control Plan Section 1.6

Monthly progress report Section 4.4

Technical Exhibit 3 Planning Workload Pricing and payment unit: Month (MO). The figures below reproduce the supplied hourly workload estimates for planning only. They are not pricing or payment units, guaranteed quantities, or an approved monthly coverage schedule. The supplied document does not identify their estimating period.

Program confirmation required: Identify the estimating period and validate whether these figures support the intended schedule. Establish the number of priced months and required monthly coverage in the contract line-item schedule after resolving section 1.4. Empty template labor-category rows have been removed.

Appendix A Privacy and Business Associate Agreement Review note: The supplied privacy and Business Associate Agreement wording below is retained without substantive revision. Its existing internal numbering is preserved and is separate from the main PWS numbering. This appendix is subject to privacy and contracting review; inclusion does not represent approval of the text or its applicability. Complete required contract and party identifiers before execution.

Privacy Act This contract requires the Contractor, on behalf of the Indian Health Service (IHS), to provide health care to American Indians and Alaskan Natives and report selected medical record and financial information to IHS. The Snyder Act (25 U.S.C. 13) and Public Law 83-5658 (42 U.S.C. 2001) authorizes the collection of this information. To be reimbursed by IHS, you must provide the information requested by delivery/task orders issued under this contract. IHS will use the information for financial, legal, research, and health care purposes.

Disclosure of this information may be made by IHS to: other providers of health care for treatment or health maintenance of American Indian or Alaskan Native people; the Office of Worker's Compensation Programs, Department of Labor; the Department of Justice for their representation of the United States; and for congressional inquiry; quality assessment, medical audit, or utilization review; billing third parties for the payment of care; analytical and evaluation studies; to Federal or State agencies as required by law, research purposes supported by IHS; and identification of handicapped children under 10 U.S.C. 1401 et. Seq.

Disclosure of the appropriate medical record information without prior consent of the subject patient may be made by you to: another provider of health care treating the same patient; a Federal or State agency as required by law such as the reporting of communicable diseases, births, deaths, or the commission of crimes (i.e., gunshot wounds, rape, child abuse or neglect, alcohol or drug abuse, etc.); and billing third parties for the payment of care not reimbursed by IHS. You must forward all other requests for information contained on this form to the applicable IHS Ordering Official.

8.1 Business Associate Agreement Clause

Pursuant to the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and its implementing regulation, the Standards of Privacy of Individual Identifiable Health Information at 45 C.F.R. Part 160 and 164, Subpart A and E (“Privacy Rule”), the Indian Health Service is required to enter into an agreement with the Business Associate, pursuant to which the Business Associate shall comply with and appropriately safeguard Protected Health Information (“PHI”) that it will use and disclose when performing functions, activities or services (“Services”) for the Indian Health Service. The Business Associate by signing the contract shall comply with the following terms in addition to other applicable contract terms and conditions relating to the safekeeping, use and disclosure of PHI.

8.2 Definitions:

Terms used in this Agreement, but not otherwise defined, shall have the same meaning as those terms contained within the Privacy Rule.

Agreement: “Agreement” shall mean this clause and any other provisions of this contract that are incorporated by reference;

Business Associate: “Business Associate” shall mean the Contractor, also known as ( );

Covered Entity: “Covered Entity” shall mean the Indian Health Service;

Designated Record Set: “Designated Record Set” shall mean (1) a group of records maintained by or for a covered entity that is: (i) The medical records and billing records about individuals maintained by or for a covered health care provider, (ii) The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan, or (iii) Used, in whole or in part, by or for the covered entity to make decisions about individuals. (2) For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity. (45 C.F.R. § 164.501) Individual: “Individual” shall have the same meaning as the term “individual” in 45 C.F.R. § 164.501 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. § 164.502(g);

Privacy Rule: “Privacy Rule” shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and 164, Subparts A and E;

Protected Health Information: “Protected Health Information” shall have the same meaning as the term protected health information” in 45 C.F.R. § 164.501, limited to the information created or received by the Contractor from or on behalf of the IHS;

Required By Law: “Required By Law” shall have the same meaning as the term “required by law” in 45 C.F.R. § 164.501;

Secretary: “Secretary” shall mean the Secretary of the United States Department of Health and Human Services or his designee.

8.3. Authority:

Pursuant to 45 C.F.R. § 164.502(e), the Indian Health Service (IHS), as a covered entity, is required to enter into an agreement with a “business associate,” as defined by 45 C.F.R. § 160.103, under which the business associate must agree to appropriately safeguard Protected Health Information (PHI) that it will use and disclose when performing functions, activities or services pursuant to its contract with the IHS. By signing Contract No. ________ (Contract), _______________ agrees that it is a Business Associate and will comply with the terms below, in addition to other applicable Contract terms and conditions, and applicable law, relating to the safekeeping, use, and disclosure of PHI. This Appendix comprises the Business Associate Agreement (Agreement).

8.4. Definitions:

The following terms shall have the same meaning as those terms in 45 C.F.R. Part 160 and Part 164, which are the federal regulations implementing the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended: Breach, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, PHI, Required by Law, Secretary, Security Incident, Subcontractor, Unsecured PHI, and Use.

Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 C.F.R. § 160.103, and in reference to the party to this Agreement shall mean ____________.

Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 C.F.R. § 160.103, and in reference to the party to this Agreement, shall mean the IHS.

HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and Part 164.

8.5. Master Patient Index (MPI):

The “Master Patient Index” or “MPI” is composed of a unique list of patients and a current list of medical centers where each patient has been seen. This enables the sharing of patient data between operationally and regionally diverse systems. Each record (or index entry) on the MPI contains a small amount of patient data used to identify individual entries.

The mission of the MPI is to uniquely identify a patient and to “link” that patient’s data throughout the IHS facilities using the Integration Control Number (ICN). The MPI is the authoritative source of a patient’s ICN, the enterprise-wide identifier for IHS facilities and the key to accessing a patient’s record. The accuracy of patient information and patient identification directly affects clinical, administrative, billing, and interdepartmental processes.

8.6 Obligations and Activities of Business Associate:

8.6.1Compliance: Business Associate agrees not use or disclose PHI other than as authorized by the Agreement or as required by law. Business Associate acknowledges that it is directly liable under the HIPAA Rules and subject to civil and, in some cases, criminal penalties for making uses and disclosures of PHI that are not authorized by the Agreement or required by law. Business Associate agrees that it will require all of its agents, employees, subsidiaries, and affiliates, to whom Business Associate provides PHI, or who create or receive PHI on behalf of Business Associate for Covered Entity, to comply with the HIPAA Rules and to enter into written agreements with Business Associate that provide the same restrictions, terms, and conditions as set forth in the Agreement.

8.6.2. Subcontractors: In accordance with 45 C.F.R. §§ 164.502(e)(1)(ii) and 164.308(b)(2), which govern relations with subcontractors, Business Associate agrees to ensure that any subcontractors that create, receive, maintain, or transmit PHI on behalf of Business Associate agree to the same restrictions, terms, and conditions that apply to Business Associate with respect to such PHI.

C. Safeguarding PHI: Business Associate shall develop and use appropriate procedural, physical, and electronic safeguards to protect against the use or disclosure of PHI in a manner not authorized by this Agreement or required by law. Business Associate will limit any use, disclosure, or request for use or disclosure of PHI to the minimum amount necessary to accomplish the intended purpose of the use, disclosure, or request.

8.6.3 Safeguarding Electronic PHI: Business Associate agrees to use appropriate safeguards, as set forth in Subpart C of 45 C.F.R. Part 164 with respect to electronic PHI, to prevent use or disclosure of electronic PHI other than as authorized by this Agreement or required by law.

8.6.4. Reporting Use or Disclosures Not Authorized By this Agreement or Required by Law: Business Associate agrees to report to Covered Entity any use or disclosure of PHI not authorized by this Agreement or required by law within thirty (30) days of discovering the use or disclosure, or any security incident of which it becomes aware. In addition, Business Associate shall mitigate, to the extent practicable, any harmful effect that is known to Business Associate of the use, disclosure, or security incident.

8.6.5. Reporting of Breach: In accordance with the policy of the Department of Health and Human Services, Business Associate will report, within one hour of discovery, all suspected or confirmed breaches to Covered Entity.

8.6.6. Notification of Breach of Unsecured PHI: In addition to the above, Business Associate shall notify Covered Entity of a breach, as set forth in 45 C.F.R. § 164.410, of the security of any unsecured PHI that Business Associate received from, or created or received on behalf of, Covered Entity within thirty (30) calendar days after the discovery of the breach by Business Associate, its employees, officers, and/or other agents, unless notification is specifically excepted by 45 C.F.R. § 164.412.

Requirements of Notice. Such notice shall include, to the extent possible, the identification of each individual whose unsecured PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, or disclosed during such breach; a brief description of the circumstances of the breach of security, including the date of the breach and the date of Business Associate’s discovery of the breach; and the type of unsecured PHI involved in the breach. Business Associate agrees to provide any other available information that Covered Entity is required to include in notification to the individual under 45 §164.404(c). In the event notification is delayed, evidence demonstrating the necessity of the delay shall accompany the notification.

8.6.7. Individual Access to PHI: Business Associate shall maintain a designated record set for each individual for whom it maintains PHI. In accordance with an individual’s right to access his or her PHI, Business Associate shall make available all PHI in the individual’s designated record set to the individual to whom that information pertains, or, upon the request of the individual, to that individual’s authorized representative, as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.524. Availability to access PHI shall be made within five (5) calendar days of receipt of a valid request.

8.6.8 Accounting of Disclosures: Business Associate shall maintain records of PHI received from, or created or received on behalf of, Covered Entity and shall document subsequent uses and disclosures of such information by Business Associate. Business Associate shall, within five (5) calendar days after receiving a request from Covered Entity, provide to Covered Entity such information as Covered Entity may require to fulfill its obligations to account for disclosures of PHI pursuant to 45 C.F.R. § 164.528.

8.6.