Atch2_36C25522Q0099_CSS_SleepStudies_PWS.pdf

Combined Synopsis-Solicitation for Commercial Items Request for Quotation (RFQ) 36C25522Q0099

PERFORMANCE WORK STATEMENT

ON-SITE SLEEP STUDY SERVICES

Attachment 2

1. GENERAL

1.1. Services to be Performed: The Contractor Shall Furnish all personnel necessary to provide On-Site Sleep

Study Services and Scoring using Registered Polysomnographic Technicians (RPSGT) to acquire sleep studies on-site at the VA Sleep Center to eligible beneficiaries of the Department of Veterans Affairs (VA), Robert J. Dole (RJD) VA Medical Center (VAMC).

NOTE: This is a solicitation document and is the performance work statement intended to be included in a resulting contract award document. Exception: All references to solicitation / quote / offer or similar terminology will be removed from the document at the time of a resulting contract award.

Contractor shall perform sleep studies Nightly, 7 days per week, 365 days per year, including weekends and holidays.

Services shall conform to the American Academy of Sleep Medicine (AASM) standard guidelines, https://www.aasm.org/clinical-resources/practice-standards/practice-guidelines/. The VAMC requires RPSGT services to score the acquired sleep studies per the ASSM guidelines for Scoring of Sleep and Associated Events, https://www.aasm.org/clinical-resources/scoring-manual/.

Contractor-performed diagnostic procedures shall include patient appointment scheduling, and re-scheduling as necessary, and performance of sleep studies, including, but not limited to full night diagnostic, full night CPAP/BiPAP, split night studies, scoring of home sleep apnea tests (HSAT) scoring, multiple sleep latency tests (MSLT), and maintenance of wakefulness tests (MWT), and all aspects of patient preparation, monitoring and study management.

1.1.1. On-Site Study and HSAT scoring shall be completed using either Respironics Alice 6 computer program or VA’s Somnoware VA-network-based program. Contractor RPSGTs shall be adept in the operation of both systems.

1.2. The VA will provide all necessary space – bedroom(s) with bed(s), equipment, computer network access, programs and software, and associated supplies and consumables required to perform all studies, including linens, oxygen and compressed air, and a locking storage space/closet area.

1.3. Contractor-performed sleep studies (full night diagnostic, full night CPAP/BiPAP, split night and home multiple sleep latency test (MSLT) and maintenance of wakefulness test (MWT) will be acquired at the VA Sleep Center and will consist of four or more sleep stages.

1.4. HSAT equipment items are, and shall always remain the property of VA, issued to the Veteran by the VA, to include supplies needed to perform the HSAT at Veteran’s home. HSAT equipment is picked up by the Veteran at the Wichita Facility, or at one of the outlying Community Based Outpatient Clinics (CBOCs), or are mailed to Veteran by VA. Upon the veteran’s return of the HSAT equipment to the VA, the HSAT shall be scored by Contractor’s RPSGT within 24 hours of receiving HSAT device from VA. If an HSAT cannot be scored and completed, Contractor shall promptly notify the VA of the incomplete HSAT and document the patient record.

https://www.aasm.org/clinical-resources/practice-standards/practice-guidelines/ https://www.aasm.org/clinical-resources/scoring-manual/

1.5. On-site equipment items are, and shall always remain the property of VA. All equipment required for performing polysomnography will be provided by the VA. CPAP/BiPAP and Home Sleep Study equipment will also be provided by the VA. In-service, education, maintenance and upgrade agreements and contracts with equipment vendors are sole functions of the VA.

1.6. Contractor shall not interpret sleep studies. VA physicians will interpret sleep studies scored by the contractor.

1.7. Place of Performance - Sleep Center, Robert J. Dole VAMC, 5500 East Kellogg Dr., Wichita, KS 67218.

1.8. Authority: Solicitation and Award shall utilize the procedures as set for the Federal Acquisition Regulation Parts 12 and 15.

2. POLICIES / HANDBOOKS

2.1. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The Contracting Officer will provide updated handbooks or internet address links upon request if offeror/contractor experiences difficulties with accessing the stated links below.

2.1.1. VHA Handbook 1100.17: National Practitioner Data Bank Reports https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135

2.1.2. VHA Handbook 1100.18: Reporting And Responding To State Licensing Boards https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364

2.1.3. VHA Directive 1192: Seasonal Influenza Prevention Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472

2.1.4. VHA Directive 1220: Facility Procedure Complexity Designation Requirements to Perform Invasive

Procedures In Any Clinical Setting https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365

2.1.5. VHA Directive 1400.01: Supervision of Physician, Dental, Optometry, Chiropractic, and Podiatry Residents (remove if not applicable) https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8579

2.1.6. VA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

2.1.7. VHA Handbook 1907.01: Health Information Management and Health Records https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

2.1.8. Privacy Act of 1974 (5 U.S.C. 552a) as amended

http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

3. DEFINITIONS / ACRONYMS

3.1. Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

3.1.1. AASM: American Academy of Sleep Medicine

3.1.2. AOD: Admitting Officer of the Day

3.1.3. BLS: Basic Life Support

3.1.4. BRPT: Board of Registered Polysomnographic Technologists https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5472 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8365 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8579 https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

3.1.5. CDC: Centers for Disease Control and Prevention

3.1.6. CR: Contract Report (formerly CDR, Contract Discrepancy Report)

3.1.7. CMS: Centers for Medicare and Medicaid Services

3.1.8. Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

3.1.9. Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

3.1.10. COS: Chief of Staff

3.1.11. CPARS: Contractor Performance Assessment Reporting System

3.1.12. CPRS: Computerized Patient Record System (see also EHR below)

3.1.13. CPT: Common Procedural Terminology – As used here, CPT is a code with an associated description of a procedures. CPT is not used as a pricing or cost factor and as used here, is a service description only.

3.1.14. DEA: Drug Enforcement Agency

3.1.15. ED: Emergency Department

3.1.16. EHR: Electronic Health Record - electronic health record system used by the VA ** Note – EHR and

CPRS are used interchangeably in this document and contract performance, and both refer to the same system type, function and purpose.

3.1.17. FSMB: Federation of State Medical Boards

3.1.18. HHS: Department of Health and Human Services

3.1.19. HIPAA: Health Insurance Portability and Accountability Act

3.1.20. HR: Human Resources

3.1.21. ISO: Information Security Officer

3.1.22. Medical Emergency - a sudden onset of a medical condition manifesting itself by acute symptoms of sufficient severity that the absence of immediate medical attention could reasonably result in:

Permanently placing a patient's health in jeopardy, causing other serious medical consequences, Causing impairments to body functions, or Causing serious or permanent dysfunction of any body-organ or part.

3.1.23. MOD: Medical Officer of the Day

3.1.24. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers).

3.1.25. Non-Contract Provider - any person, organization, agency, or entity that is not directly or indirectly employed by the Contractor or any of its subcontractors

3.1.26. NP: Nurse Practitioner

3.1.27. NPPES: National Plan and Provider Enumeration System

3.1.28. PA: Physician Assistant

3.1.29. POP: Period of Performance

3.1.30. PPD: Purified Protein Derivative

3.1.31. PWS: Performance Work Statement

3.1.32. QASP: Quality Assurance Surveillance Plan

3.1.33. RPSGT: Registered Polysomnographic Technician

3.1.34. Veterans Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.

3.1.35. Veterans Integrated Services Network (VISN) : The regional oversight for the VA medical centers.

3.1.36. VISTA (Veterans Integrated Systems Technology Architecture) : A PC based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient’s medical record and with the hospital information system.

3.1.37. VetPro: a federal web-based credentialing program for healthcare providers.

3.1.38. Veterans Affairs Medical Center (VAMC) : Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Robert J. Dole (RJD) Medical Center.

4. QUALIFICATIONS

4.1. Staff:

4.1.1. Registration - The Contractor RPSGT assigned to perform the services covered by this contract shall be currently registered to in any State, Territory, or Commonwealth of the United States or the District of Columbia) to perform the RPSGT scope of practice when services are performed onsite on VA property.

4.1.2. All registrations held by the personnel working on this contract shall be full and unrestricted.

Contractor RPSGT personnel who have current, full and unrestricted registrations in one or more states, but who have, or ever had, a registration restricted, suspended, revoked, voluntarily revoked, voluntarily surrendered pending action or denied upon application will not be considered for the purposes of this contract. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approved by the VA Facility Director.

4.1.3. Board Certification - All contractor RPSGT personnel shall be certified by the Board of Registered Polysomnographic Technologists (BRPT), and be currently certified in Basic Life Support (BLS) or equivalency in conjunction with RPSGT work in accordance with AASM guidelines consisting of Scoring acquired Sleep Studies –

4.1.3.1. Full Night CPAP/BiPAP,

4.1.3.2. Split Night,

4.1.3.3. HSAT,

4.1.3.4. MSLAT/MWAT

4.1.4. RPSGT shall have knowledge of respiratory, neurological, cardiac and psychiatric conditions associated with sleep disorders, be able to recognize epileptiform discharges, paroxysmal slow wave activity, changes in sleep architecture, cardiac arrhythmias, Cheyne-Stokes respirations, mixed hypopneas and normal sleep patterns. Technicians providing services shall be knowledgeable in electroencephalography (EEG) and electromyography (EMG), and respiratory care.

4.1.5. RPSGT licenses and certifications must be kept current and active at all times. Documentation verifying current licenses and certifications shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

4.1.6. RPSGT services shall not be performed prior to obtaining approval, including network access, completion of security processes and background investigation scheduling, and issuance of a VA-issued Access Badge (Personal Identity Verification or USAccess Card).

4.1.6.1. If any RPSGAT is not approved, the Contractor shall immediately propose a substitute RPSGT with a suitable, equally qualified RPSGAT, to the Contracting Officer without any additional cost to the government. The Contracting Officer will consider the proposed substitute’s addition to the contract.

4.1.7. Technical Proficiency – Contractor RPSGATs shall be technically proficient in the skills necessary to fulfill the government requirements under the contract, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences related to performance of the requirements of the contract.

Contractor is responsible for RPSGT conformance with the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior, including conformance to the requirements of the contract.

4.1.8. Training (BLS, EHR and VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the Contractor’s RPSGT as required by the VA. The VA reserves the right to add training requirements as may become necessary for efficient operation of services and where mandated by law, regulation or policy. VA will communicate any change requirements to the contractor.

4.1.9. All required training shall be at Contractor expense except where VA provides the equipment, e.g.

computers, trainers and space to the Contractor for training completion.

4.1.10. All training shall be completed at time other than while performing sleep studies and related functions, e.g. patient observation, etc.

Training (The following training is mandatory per VHACO for Contracted Physicians) Frequency (once a year, etc)

Annual Hours (approximate # of hours)

Mandatory Training for Transient Clinical Staff (TMS #20152), which includes:

Active Threat Training; Government Ethics; Prevention of Workplace Harassment/No Fear Act; Mil itary Sexual Trauma (MST) for Medical Providers; SUX Infection Control and Blood Borne Pathogens;

Prevention of Workplace Harassment/No Fear Act; VHA MRI Safety Training Level 1 Training (all who enter MRI suites); VA Core Values Training (ICARE Recommitment); VHA Privacy and HIPAA Focused Training; Patient Safety; Patient Rights; Patient Abuse; Prevention / Management of Disruptive Behavior / Violence Prevention Level I;

Suicide Prevention: Suicide Risk Management Training for Cl inicians

Prior to Performance, then Annually

2 hours

VA Privacy and Information Security Awareness and Rules of Behavior

(TMS 10176)

Prior to Performance, then Annually

1 hour

BLS Prior to Performance, then Biennially

EHR (Electronic Health Records / CPRS) & VistA Imaging One-time, Hands-on Training

1 hour

Table 4.1.10.

4.1.11. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for physicians within five (5) calendar days after contract award and prior to starting performance to the Contracting Officer. Tests shall be current within the previous one (1)-year prior to start of performance.

4.1.11.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin

Test (TST) or interferon-gamma release assays (IGRA) for all Contractor RPSGT personnel.

A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

4.1.11.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor RPSGTs.

4.1.11.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor RPSGTs.

4.1.11.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor RPSGTs.

4.1.11.5. INFLUENZA: Contractor shall provide proof that all Contractor RPSGTs have received the annual Influenza vaccine unless it is contraindicated. If the Contractor RPSGT has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season.

4.1.11.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE

PATHOGENS: Contractor shall provide evidence of completing and passing generic self-study blood-borne pathogen training for all Contractor RPSGTs; provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan;

maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

4.1.11.7. The VAMC shall notify the Contractor of any significant communicable disease exposures as appropriate. Contractor shall adhere to current CDC/HICPAC Guideline for Infection Control in health care personnel (as published in American Journal for Infection Control- AJIC 1998; 26:289-354 http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf) for disease control. Contractor shall provide follow up documentation of clearance to return to the workplace prior to their return.

4.1.11.8. COVID-19 Vaccination(s) Requirement: Where a COVID vaccine is or will be mandatory for RJD employees and contractors who provide health care functions, including the requirements of this contract, contractors shall provide proof, prior to performance, that all Contractor RPSGTs have received the / a COVID vaccine, to a “fully-vaccinated” status according to the specific vaccination type or brand of vaccination, at contractor cost, unless it the vaccinations are medically contraindicated. If any key personnel contracts COVID, or tests positive through a viral test or antibody test for COVID, the contractor shall immediately remove the RPSGT from performance under the contract and immediately provide a replacement for continued performance of the contract. The COVID positive RPSGT may return to contract performance based on Dole VA employee http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf health guidelines. Contractor shall provide evidence of Contractor’s RPSGTs’ vaccinations equal to those required of VA employee healthcare workers, such as COVID vaccinations.

4.1.11.9. Use of Masks, other Personal Protective Equipment (PPE): Contractor’s RPSGTs shall abide by all VAMC mask and PPE requirements as established by VA and RJD policies while on VAMC property, including entrances/common areas, patient exam locations, during patient encounters and duty/work areas during performance of the contract where masks and PPE requirements are indicated by the policies, and in common areas, e.g. hallways, etc.

4.1.12. Conflict of Interest: The Contractor and all contractor RPSGTs are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest (Jan 2008) and fully outlined in response to the subject attachment in the solicitation document.

4.1.13. Citizenship related Requirements:

The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

4.1.14. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s RPSGTs are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractor RPSGTs or the Contractor firm are not listed as of the date the quote was submitted.

4.2. Clinical/Professional Performance: The qualifications of Contractor personnel are subject to review by VA

Medical Center CoS (Chief of Staff) or his/her clinical designee and approval by the Medical Center Director as provided in VHA Handbook 1100.19. Clinical/Professional performance monitoring and review of all clinical personnel covered by this contract for quality purposes will be provided by the VAMC COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

4.3. Non Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s RPSGTs shall not be considered VA employees for any purpose.

4.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

4.5. Prohibition Against Self-Referral: Contractor’s RPSGTs are prohibited from referring VA patients to contractor’s or their own practice(s).

http://oig.hhs.gov/exclusions/index.asp

4.6. Inherent Government Functions: Contractor and Contractor’s RPSGTs shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

4.7. No Employee status: The Contractor shall be responsible for protecting Contractor’s RPSGTs furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

4.7.1. Workers’ compensation

4.7.2. Professional liability insurance

4.7.3. Health examinations

4.7.4. Income tax withholding, and

4.7.5. Social security payments.

4.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s RPSGTs. When a

Contractor or Contractor’s RPSGTs has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or Contractor’s RPSGTs) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

4.9. Key Personnel: Note: “Replacement” differs from “Substitution”. For the purpose of this contract:

Replacement refers to supporting the contract requirements with a pre-existing approved key personnel in place of another approved key personnel.

4.9.1. The minimum number of RPSGTs shall be established by the contractor in the quantities and schedules sufficient to perform the services described every day of the year commencing with the first day of the period of performance for two (2) patients daily for overnight studies, scheduled by the contractor, year-round – 52 weeks per year, seven (7) days per week, and additional periodic studies outside of the “overnight” schedule, which will occur in day-time hours between 8:00 a.m.

Central Time and 5:30 p.m. Central Time. The contractor shall be responsible for scheduling contractor RPSGTs to perform the contract.

4.9.1.1. The contractor shall maintain sufficient available staff for replacement of absent RPSGTs, including advanced, planned absences and unplanned, little or no-notice absences.

“Absences” also includes RPSGT illness or injury while performing the contract.

4.9.1.2. The contractor shall provide immediate replacement of absent RPSGTs within 60 minutes of notification of the absence.

4.9.2. Personnel Substitution: Note: “Substitution” differs from “Replacement”. For the purpose of this contract: Substitution refers to key personnel removal and replacement.

4.9.2.1. Substitutions of Key Personnel is not in the best interest of Government and contract performance. The Contractor shall maintain RPSGT staffing for the duration of the period(s) of performance and avoid substitutions. Contractor shall make NO key personnel substitutions during the first one hundred eighty (180) calendar days of contract performance.

4.9.2.1.1. Exception: Should substitution be necessitated due to long-term absence conditions, such as illness, death or termination of employment, Contractor shall evidence the long term absence by –

4.9.2.1.1.1. Notifying the Contracting Officer verbally, followed up in writing, and

4.9.2.1.1.2. Immediately surrendering the RPSGT’s PIV Card (or USAccess Card) to either the

Contracting Officer, the COR or to the VA Police.

4.9.2.2. The Contractor shall notify the CO, in writing, within 3 business days of the need for substitution.

4.9.2.3. For substitution needs after 180 calendar days of contract performance, the Contractor shall propose the key personnel change not less than 30 calendar days prior to the expected date of the loss of key personnel.

4.9.2.4. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, shall provide the same qualifications materials for the proposed substitution as for the original key personnel submitted at the time of proposal to the CO.

4.9.2.5. The Contractor shall endeavor to avoid necessity for key personnel substitution. The Government reserves the right to refuse any request for personnel substitution during the performance of the contract.

4.9.2.5.1. The Government reserves the right to refuse VA access to any Contractor RPSGT at any time after performance begins, including but not limited to refusal if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing contracted work tasks, or other conduct identified by complaints by patients, VA staff or other Government representatives.

4.9.2.5.2. Standards for conduct shall mirror those prescribed federal employees.

Documented clinical problems, unprofessional behavior or actions with any patient or VA staff may warrant CO action, including immediate refusal of VA access.

4.9.2.5.3. The CO is the final arbiter on questions of acceptability.

4.9.2.6. Contingency Plan: Because continuity of care is an essential part of VAMC’s medical service mission, the Contractor shall have and maintain, a contingency plan, having been submitted to and approved by the Contracting Officer, in place that addresses how the Contractor will perform the contract in the event(s) of personnel loss or absence, and maintain continuity of

5. HOURS OF OPERATION

5.1. VA Business Hours: Monday through Friday, except Federal Holidays, 8:00 a.m. through 4:30 p.m.

5.2. Sleep Study Clinic Hours: Year-Round: Sunday through Saturday, including Federal Holidays and Weekends, 8:00 p.m. through 8:00 a.m., and, for performance of MSLT/MWT (reference section 1), 8:00 a.m. through 5:30 p.m.

5.2.1. Patients must be seen by a Contractor’s RPSGTs on-site at (Facility) in a timely manner in accordance with VA Rules and Regulations on clinic wait times and consult completion. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

5.2.2. Contractor’s RPSGTs shall be available, present and performing services in the sleep lab during normal clinic hours stated above.

5.3. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs; however, contractor shall perform services on Federal Holidays and Weekends in accordance with section 1 above, and other places in this PWS:

• New Year’s Day

• President’s Day

• Martin Luther King’s Birthday

• Memorial Day

• Juneteenth

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

• Any day specifically declared to be a national holiday.

5.4. Cancellations: Requirements for cancellation (if any). Statement covering impact.

5.4.1. Unless a state of emergency has been declared or clinics are otherwise cancelled by the Dole

VAMC, the Contractor shall provide services required by the contract daily.

6. CONTRACTOR RESPONSIBILITIES

6.1. Clinical Personnel Required: The Contractor shall provide RPSGTs who are trained, certified, experienced, competent and qualified to perform the work required by this PWS. Contractor personnel shall perform on-site sleep studies, including but not limited to patient scheduling, patient management, assistance with patient mobility needs when physically able to assist, sleep study management and monitoring, documentation and scoring, and shall perform receipt of and documenting and scoring HSAT studies, and shall document failed or incomplete studies.

6.2. Contractor’s RPSGTs shall be responsible for signing-in and signing-out on a sleep lab attendance log, by name and duty title, each date of performance of the contract.

6.3. Standards of Care: The Contractor’s RPSGTs care shall cover the range of sleep study/studies described in this PWS and commensurate with industry standards and with VA, VHA and Dole VAMC standards of care and policies, using VA-owned equipment described herein, including conformance to the American Academy of Sleep Medicine (AASM) standard guidelines, located at https://www.aasm.org/clinical-resources/practice-standards/practice-guidelines/ and the requirements contained in this PWS .

6.4. Contractor shall document reasons for failed and incomplete studies, patient refusal of studies, including no-shows (patient does not arrive for appointment on time, or complete absence).

6.4.1. When studies are identified by the Contractor to be failed or incomplete due to clinical reasons, Contractor shall notify the VA. The VA will determine if rescheduling for a repeat study is required.

If required, the VA will issue a new order (consult) establishing the need for the study to the Contractor.

6.5. Contractor employees shall hold and maintain PIV badges for entry into the VA Medical Center and work area and use the PIV for access to the VA computer network, e-mail and programs necessary to perform the contract.

6.5.1. Contractor employees shall log into the VA network at least one (1) time every 30 calendar days to prevent loss of VA network access. Contractor employees who have lost network access shall not perform under the contract. Immediate substitution or replacement from the contract’s key personnel roster herein is required within 60 minutes.

6.5.2. Contractor employees may not utilize non-Government e-mail to communicate patient matters at any time. Only VA-issued e-mail may be utilized in the performance of the work. If patient communication by e-mail is required, the e-mail shall be encrypted and shall be limited in distribution to the minimum number of persons necessary to perform the work. Patient identification information shall not be included in the subject-line of an e-mail communication.

7. MEDICAL RECORDS

7.1.1. Authorities: Contractor’s RPSGTs providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

7.1.2. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19).

Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations.

Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

7.1.3. Disclosure: Contractor’s RPSGTs may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to http://www.rms.oit.va.gov/SOR_Records/24VA19.asp applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

7.1.4. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 and all guidelines provided by the VAMC.

7.1.5. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10- 5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer at the following address: Attn: Privacy Officer, Robert J. Dole VAMC, 5500 East Kellogg Dr., Wichita, Kansas 67218.

7.1.6. Limited Exchange of Data: Clinical data, medical records and related data shall be limited to internal VA records systems and shall not be removed, discussed, transferred or otherwise shared outside of the sleep lab clinic and with VA sleep lab personnel.

7.2. Scope of Services:

7.2.1. Contractor’s RPSGT (as appropriate and within scope of RPSGT’s practice / privileging) shall be responsible for performing all aspects of sleep studies in accordance with the PWS, including, but not limited to:

7.2.2. Direct Patient Care (Sleep Studies and related functions): 90% of the time involved in direct patient

7.2.3. ADMINISTRATIVE (documentation, scheduling and related functions): estimated 10% of time not involved in direct patient care.

7.2.4. Clinical: Contractor’s RPSGTs shall provide all services required to initiate, monitor and manage, complete, score and document sleep studies scoring, within 24 hours of completion of the study, and score and document home sleep studies from HSAT equipment provided by VA from beneficiary-originated HSAT equipment, within 24 hours of receipt of the HSAT equipment.

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088 https://vaww.va.gov/vaforms/va/pdf/VA3288.pdf https://vaww.va.gov/vaforms/va/pdf/VA3288.pdf https://vaww.va.gov/vaforms/medical/pdf/10-5345.pdf https://vaww.va.gov/vaforms/medical/pdf/10-5345.pdf

Contractor’s RPSGTs shall be present and on-time for all contractor-scheduled studies, and perform HSAT scoring during the same shift. Documentation pertaining to all procedures, complications and outcome of examinations shall be made in EHR/CPRS. Study data and score information for studies attempted, partially completed and completed shall be the sole property of, and remain in sole ownership by the VA at all times. Contractor retains no rights in any study data, regardless of status of completion.

7.2.5. Specialty Exams: The contractor shall schedule and perform specialty exams, defined as periodic, and less frequent, daytime, 8:00 a.m. to 4:30 p.m. MSLT/MWT.

7.2.6. Medications: Contractor’s RPSGTs shall not handle, issue or assist with medications at any time. VA staff shall be notified if any sleep study patient requires assistance related to medications.

7.2.7. Discharge and Release: Contractor’s RPSGTs shall present a Patient Survey Form to each patient at the conclusion of the sleep study and in sufficient time prior to discharge and release for the patient to complete the survey form prior to exiting the test area. If patient declines to complete or otherwise does not provide a returned survey, Contractor shall document the survey report regarding missing surveys

7.2.8. Scheduling Patients: Scheduling patients for on-site studies within 2 calendar days (48 hours) of VA notifying Contractor of need for a study, using VA-provided contact information. Contractor shall accommodate the patient’s scheduling needs. VA shall be immediately notified of any problems encountered in patient scheduling, e.g., incorrect phone number, address or other information preventing prompt scheduling.

7.2.9. Quality Control: {{{original PWS language says:

7.2.10. a) Contractor will perform quality control activities as part of the (AASM) American Academy of Sleep Medicine guidelines so as to maintain the AASM Accreditation sleep disorder center.

(https://aasm.org/clinical-resources/practice-standards/practice-guidelines/)

7.2.11. Patient Safety Compliance and Reporting: Contractor’s RPSGTs shall follow all established patient safety and infection control standards of care. Contractor’s RPSGTs shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported to the COR VA Safety Policy. As soon as practicable (but within 24 hours) Contractors shall notify COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

8. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) and QUALITY IMPROVEMENT(QI)

8.1.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, such as patient satisfaction surveys, and timely completion of medical records and scoring documentation and scheduling.

Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and by the methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP is not attached to, or part of the contract, however it remains a “living document” that may be changed by the Government at any time based on performance monitoring needs or changes. The QASP defines the methods and expected frequencies of surveillance conducted but shall not be construed to be the only performance monitoring performed.

8.1.2. Customer Service/Patient Complaints: The Contractor shall immediately act to resolve customer service issues and patient complaints concerning Contractor relations with the Government employees or patients with resolution within 7 days of the issue or complaint. The CO is final authority on validating complaints and resolution efforts. In the event that the Contractor or Contractor’s employees are involved and named in a validated patient complaint, the Government reserves the right to order Contractor’s immediate removal of such personnel and surrender of the person’s PIV badge to the VAMC’s security office or COR. This does not preclude refusal in the event of incidents involving physical or verbal abuse or other reasons.

The Government reserves the right to refuse acceptance of any Contractor personnel at any time, including after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility, department or services to be performed. Examples of breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for Contractor personnel conduct shall mirror those of federal employees and federal personnel regulations. The CO, in concert with the COR and other VAMC personnel, shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

8.1.3. Analysis of Timeliness of Studies. Quarterly report of timeliness data will be used to identify areas of improvement. Contractor shall act in good faith, with appropriate efforts to improve services when areas for improvement are identified and relayed to the Contractor.

8.1.4. Performance Standards:

8.1.4.1. Measure: On-Site Sleep Study Scoring

Performance Requirement: Complete scoring of all sleep studies within 24 hours of studies.

Standard: 24 hour completed study scoring and documentation Acceptable Quality Level: 97% meets Standard

8.1.4.2. Measure: Invoices and Supporting Documentation

Performance Requirement: Invoices and supporting documentation must be submitted no later than the 20th day of the month following the month of services.

Standard: All (100%) invoices and supporting documentation are submitted electronically not later than the 20th day of the following month.

Acceptable Quality Level: 100% No deviations accepted.

8.1.4.3. Measure: Current RPSGT licensing, registrations and certifications Performance Requirement: Maintains and keeps current all licenses, registrations and certifications.

Standard: All (100%) Contractor’s RPSGTs maintain licenses, registrations and certifications 100% of the time.

Acceptable Quality Level: 100% No deviations accepted.

8.1.4.4. Measure: Customer Service / Patient Complaints

Performance Requirement: Resolves customer service issues and patient complaints within seven (7) days Standard: Resolves customer service issues and patient complaints within seven (7) days.

Acceptable Quality Level: 97% meets Standard

8.1.4.5. Measure: Home Sleep Study Test (HSAT) Scoring

Performance Requirement: Receive and Complete scoring and documentation of all HSAT within 24 hours of receiving HSAT device from VAMC Medicine Service.

Standard: Receive, score and document HSAT results within 24 hours of receipt of device.

Acceptable Quality Level: (100%) of Contractor-received HSAT devices.

8.1.4.6. Measure: Scheduling On-Site Sleep Studies and Patient Contact Standard: Receive VAMC Medicine Service order (consult) for study, including patient contact and relevant information, making scheduling contact with patient, or family/caregiver within 48 hours of receipt of order (consult) and establishing a schedule appointment for study.

Acceptable Quality Level: (___%) of patient contact and scheduled appointment within 48 hours.

8.1.4.7. Measure: Documenting Failed and Incomplete Studies – On-Site and HSAT Performance Requirement: Contractor shall document failed and incomplete studies within 24 hours of a failed and incomplete study with information surrounding the failure to complete the study.

Standard: All (100%) of failed or incomplete studies documented within 24 hours Acceptable Quality Level 100%.completions.

8.1.4.8. Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Maintain patient confidentially in accordance with all laws, regulations, policies and procedures relating to Privacy,…