Statement of Work.doc

STATEMENT OF WORK (SOW)

IFCAP Tracking Number:

1. Contracting Officer’s Technical Representative (COTR).

2. Contract Title. Clinical Respiratory Services Patients are clinically evaluated for the requirements of Positive Airway Pressure (PAP) Therapy devices. Once the device is ordered, Boise VAMC requires a contractor to setup in the patient’s home to include follow-up refitting and trouble shooting. This service may also include the contractor providing, setting up and monitoring oximetry in the patient’s home.

3. Background. Services are currently being paid as "fee for service" under a Memorandum of Agreement.

4. Scope.

Accreditation

The Contractor must meet or exceed all Joint Commission on Accreditation of Healthcare Organizations standards for all services provided herein. The Contractor must submit written documentation of meeting or exceeding all Joint Commission Home Care Standards for Clinical Respiratory Services, current edition, as part of its technical proposal and updated yearly thereafter. The Joint Commission Standards can be accessed at www.jointcommission.org. The contractor must be accredited by a nationally recognized organization and must maintain that accreditation throughout the term of the contract. If contractor receives conditional accreditation or does not meet Joint Commission standards, the VA must receive immediate notification in writing citing the follow-up action plan. If Joint Commission accreditation or standards cannot be met, the VA reserves the right to terminate the contract.

Non-personal Healthcare Services Contract

The service portion of this contract is a non-personal health care services contract in which the personnel rendering the services are not subject, either by the contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationship between the Government and its employees. The Government will evaluate the quality of professional and administrative services provided but retains no control over the medical and professional aspects of the services rendered. The Contractor shall be fully responsible for the actions of its employees and shall indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

Contract Administration

Only the Contracting Officer has the authority to make changes that affect the Contract in terms of quality, quantity, price or delivery. Under no circumstance shall anyone enter into any verbal or written understanding, agreement, modification, or changes to this contract other than the Contracting Officer. Deviations from the terms of the contract shall not be effective or binding upon the Government.

Health Insurance Portability and Accounting Act (HIPAA)

Standards to Protect the Privacy and Security of Protected Health Information (PHI) as required by HIPPA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). In accordance with HIPAA, the Contractor may be required to enter into a Business Associate Agreement (BAA) with the VA.

Scope

From time to time, the number of veterans being served by this agreement will change. The volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA either minimum or maximum. The contract shall be for the actual requirements of the VA as ordered by the VA during the life of the contract. The Contracting Officers Representative (COR) or designee will provide the contractor with notification to initiate individual beneficiary service requirements via fax, telephone or encrypted electronic means; including the beneficiary's prescription, equipment, supplies and services to be provided including date and place of delivery. The contractor will confirm receipt of the request within two working hours of notification via fax, telephone or encrypted electronic means. The COR or designee will also provide notification of VA initiated discontinuance of service. The notification may be made orally but will be confirmed in writing within three (3) working days. This contract encompasses clinical respiratory services including: set up of positive airway pressure (PAP) devices and related equipment, PAP mask fittings, equipment exchanges, PAP pressure changes, nocturnal oximetry, and exercise oximetry. All services will be performed by qualified and competent personnel in the veteran's place of residence, at the contractor's facility. The equipment needs are subject to change as determined by the prescribing physician. The geographical boundaries described herein have been determined as the areas of responsibility/jurisdiction for the Boise VA Medical Center.

Boise VAMC includes the following counties:

Idaho: Lemhi, Valley, Adams, Washington, Custer, Boise, Gem, Payette, Owyhee, Twin Falls, Lincoln, Jerome, Cassia, Minidoka, Butte, Camas, Elmore, Ada, Canyon, Blaine, Gooding

Oregon: Grant, Harney, Malheur, Baker

1. Positive Airway Pressure Therapy (PAP): The system includes but is not limited to PAP Therapy devices (CPAP, APAP, BiPAP, VPAP, BiPAP ST, and BiPAP SV), humidifier, mask, tubing, filters and accessories. The contractor shall maintain a stock of government-owned PAP Therapy equipment and shall provide sufficient space for storage of VA owned equipment.

A. Staff: A Certified or Registered Respiratory Therapist (CRT/RRT) or Registered Polysomnography Technologist (RPSGT) must be on staff to set up and troubleshoot PAP equipment. The respiratory therapist service called for in this contract must be licensed to practice sleep related respiratory care in Idaho and Oregon and proof of licensure must be provided to the BVAMC upon contract acceptance and yearly thereafter. The Contractor must provide proof of continuing education, training and competencies on an ongoing basis to the BVAMC. As part of the BVAMC orientation, CRT/RRT/RPSGT will be required to attend two (2) PAP Clinics at the BVAMC prior to providing services to VA beneficiaries.

B. Initial set up: Services will include initial set up, training, instruction, troubleshooting and mask fitting of PAP devices (Item CS1). Set up will include a mask provided by the contractor at no additional charge. The equipment will become the property of the beneficiary. Set up will occur at beneficiary's place of residence, Contractor facility or BVAMC site. This service shall be available Monday through Friday during the Contractor's normal business hours except for national holidays. Set up paperwork shall include any special incidents including but not limited to: infection control issues, communicable disease incidents, safety concerns, fall risk assessment, medical assistance and refusal of therapy. Any supplies needed after the initial 30-day mask guarantee period will be provided by the BVAMC.

C. Orders: Prescription orders will be placed by the CPAP Coordinator or designee. Orders are authorized to be placed by way of fax or telephone. Telephone orders must be followed by a written order within two (2) business days. No deviation from orders shall be allowed without prior consent from the CPAP Coordinator or designee, which will be followed by a new physician's order. The Contractor will fax confirmation of receipt of order to the CPAP Coordinator within two (2) hours of receiving a consult from the VA.

D. Mask Refitting: The Contractor shall provide mask-refitting services by a CRT/RRT/RPSGT. Request for mask refitting must be approved by PAP Coordinator or designee. Specific masks/interfaces may be requested, or vendor staff may be asked to make a judgment with beneficiary input. The contractor will provide a mask at no additional charge. If a mask refitting is requested within 30 days of initial set up, the Contractor must use the manufacturer’s mask replacement program services, which allow replacement of a mask at no charge. (Item CS4 on Schedule of Supplies) E. Equipment Exchange: PAP equipment exchanges must be approved by the CPAP Coordinator or designee prior to exchange. A new consult must be generated by the CPAP Coordinator prior to exchange. Exchange must be conducted by a CRT/RRT and will be considered an RT visit. (Item CS4 on Schedule of Supplies)

F. Pressure Change: PAP pressure change orders must be approved by the CPAP Coordinator or designee. This will be considered an RT visit. (Item CS4 on Schedule of Supplies) G. Instruction: The Contractor's CRT/RRT/RPSGT will provide instruction on the proper use and care of PAP equipment and supplies. This information is to be presented verbally, in demonstration (including return demonstration by the beneficiary and/or caregiver) and material covered shall be in written form to be left with the beneficiary/care giver. The written material shall be in English as well as the foreign language of the beneficiary, should the beneficiary and/or caregiver not speak English. In the case of such an occurrence, The Contractor is to advise the BVAMC to facilitate adequate instructions. All patient education material must be presented in written form to the COR for approval prior to the award. The Contractor, as directed by the COR or designee will implement any new or revised education material. The VA will determine whether the contractor shall use their forms or forms supplied by the VA for documentation of services provided to VA beneficiaries. Instruction will include: electrical safety, maintenance (both scheduled and unscheduled), proper cleaning, troubleshooting and demonstration. Completed patient education information and initial set up documentation will include: type of equipment issued (including serial numbers if applicable), type and size of mask, problems encountered during set up and fall risk/home safety assessment. It must be signed by beneficiary or caregiver and Contractor's CRT/RRT and sent to the BVAMC within two (2) business days of delivery or set up. This is considered part of the initial setup and does not warrant additional payment to the contractor.

1. Veterans will be provided a copy of VA Patient's Rights and Responsibilities and any advance information concerning directives. Contact information for the VA and Joint Commission will also be provided. The Contractor shall document that the beneficiary/care giver is instructed in accordance with Joint Commission Standards for Clinical Respiratory Services.

H. Appointments: The Contractor is responsible for scheduling appointments. Initial contact with beneficiary must be made within two (2) business days of receipt of order from BVAMC. In the event that the contractor is unable to contact the beneficiary after three (3) attempts, the contractor will notify the PAP Clinical Coordinator by telephone, fax or encrypted email. The Contractor shall visit beneficiaries' residences in performance of this contract by appointment only, at a time mutually agreed upon by the patient and/or caregiver and Contractor; exceptions will be made in the cases of emergencies. On each scheduled setup/delivery the Contractor shall reassess the need to instruct the beneficiary on the use and care of the equipment and supplies as necessary.

1. The Contractor is responsible for making every effort to establish appointments with VA beneficiaries when initiating set ups and deliveries. Deliveries will not be left unattended at the beneficiary's home. If the VA beneficiary chronically fails to meet appointments, the Contractor is to notify the COR or designee. The COR or designee will contact the VA beneficiary and a corrective action plan will be implemented. COR or designee will notify the Contractor of any changes. If the Contractor has not made valid and documented attempts to contact the VA beneficiaries for set ups and or deliveries, the Government reserves the right to call in a third party and bill the Contractor if the Contractor fails to perform.

2. Oximetry: Services will include exercise Oximetry (at rest and with exertion) and nocturnal oximetry (NOC oximetry). The contractor shall provide the equipment necessary to perform this service.

A. Staff: A Certified or Registered Respiratory Therapist (CRT/RRT) or Registered Polysomnographic Technologist (RPSGT) must be on staff to set up and troubleshoot oximetry equipment. The respiratory therapist service called for in this contract must be licensed to practice in Idaho and Oregon and proof of licensure must be provided to the BVAMC upon contract acceptance and yearly thereafter. The Contractor must provide proof of continuing education, training and competencies on an ongoing basis to the BVAMC.

B. Initial Set up - NOC oximetry: Contractor shall deliver NOC oximetry equipment by mail, which will include: instructions for use; instructions for application (i.e. with PAP therapy and/or oxygen), patient log and instructions/supplies for return shipment. Oximeter must have internal memory and the ability to print detailed data. (Item CS2 on Schedule of Supplies)

1. SpO2 results shall be downloaded by the Contractor and faxed to the CPAP, Home Oxygen Coordinator or designee within two (2) business days of equipment return. Documentation should detail the conditions under which the readings were obtained: date, time of measurement, pulse oximeter readings, patient's position, activity level, supplemental oxygen flow, (specifying the type of oxygen delivery device), probe placement site and/or PAP type and pressure.

C. Initial Set Up – Exercise Oximetry: Contractor shall conduct exercise oximetry at patient’s residence. Oximetry will include Sp02 for the following: resting on Room Air (RA), ambulation on RA, resting on oxygen (if applicable) and ambulation with oxygen (if applicable). Specific instructions for titration shall be included on the order from the BVAMC. (Item CS3 on Schedule of Supplies)

1. SpO2 results shall be recorded by Contractor and faxed to the Home Oxygen Coordinator or designee within two (2) business days of test. Documentation should detail the conditions under which the readings were obtained: date, time of measurement, pulse oximeter readings, time and distance walked, supplemental oxygen flow (specifying the type of oxygen delivery device) and probe placement site.

2. Any adverse reactions during testing will be documented and faxed to the Home Oxygen Coordinator or designee within twenty-four (24) hours.

D. Orders: Prescription orders will be placed by the CPAP Coordinator, Home Oxygen Coordinator or designee. Orders are authorized to be placed by way of fax or telephone. Telephone orders must be followed by a written order within two (2) business days. Orders shall specify correct application of Oximetry (nocturnal or exercise) and any additional items such as oxygen and/or PAP therapy. No deviation from orders shall be allowed without prior consent from the CPAP Coordinator, Home Oxygen Coordinator or designee, which will be followed by a new physician's order. The Contractor will fax confirmation of receipt of order to the CPAP Coordinator, Home Oxygen Coordinator or designee within two (2) hours of receiving a consult from the VA.

E. Instruction: The Contractor's CRT/RRT/RPSGT will provide instruction on the proper use and care of the oximeter. This information is to be presented verbally and material covered shall be in written form to be left with the beneficiary/care giver. The written material shall be in English as well as the foreign language of the beneficiary, should the beneficiary and/or caregiver not speak English. In the case of such an occurrence, The Contractor is to advise the BVAMC to facilitate adequate instructions. All patient education material must be presented in written form to the COR for approval prior to the award. The Contractor, as directed by the COR or designee will implement any new or revised education material. The VA will determine whether the contractor shall use their forms or forms supplied by the VA for documentation of services provided to VA beneficiaries. Instruction will include: proper application, troubleshooting and demonstration. Completed patient education information and initial set up documentation will include: type of equipment issued (including serial numbers if applicable), problems encountered during set up, and/or environmental concerns. Documentation for exercise oximetries must be signed by beneficiary or caregiver and Contractor's CRT/RRT and sent to the BVAMC within two (2) business days of test completion. Documentation for nocturnal oximetries must be signed by beneficiary or caregiver and Contractor's CRT/RRT and sent to the BVAMC within two (2) business days of download.

1. Veterans will be provided a copy of VA Patient's Rights and Responsibilities and any advance information concerning directives. Contact information for the VA and Joint Commission will also be provided. The Contractor shall document that the beneficiary/care giver is instructed in accordance with Joint Commission Standards.

F. Equipment: The oximetry equipment shall have preventative maintenance performed in accordance with manufacturer's recommendations at the contractor’s expense. Documentation of such will be provided to the COR annually.

G. Appointments: The Contractor is responsible for scheduling appointments. Initial contact with beneficiary must be made within forty-eight (48) hours of receipt of order from BVAMC. In the event that the contractor is unable to contact the beneficiary after three (3) attempts, the contractor will notify the PAP Clinical Coordinator by telephone, fax or encrypted email. The Contractor shall visit beneficiaries' residences in performance of this contract by appointment only, at a time mutually agreed upon by the patient and/or caregiver and Contractor; exceptions will be made in the cases of emergencies. On each scheduled setup/delivery the Contractor shall reassess the need to instruct the beneficiary on the use and care of the equipment and supplies as necessary.

1. The Contractor is responsible for making every effort to establish appointments with VA beneficiaries when initiating set ups and deliveries. Deliveries will not be left unattended at the beneficiary's home. If the VA beneficiary chronically fails to meet appointments, the Contractor is to notify the COR or designee. The COR or designee will contact the VA beneficiary and a corrective action plan will be implemented. COR or designee will notify the Contractor of any changes. If the Contractor has not made valid and documented attempts to contact the VA beneficiaries for set ups and or deliveries, the Government reserves the right to call in a third party and bill the Contractor if the Contractor fails to perform.

3. Employee Certification: The Contractor shall develop, maintain, and make available for review, personnel folders on all employees performing under this contract.

A. A Certified or Registered Respiratory Therapist (CRT/RRT) or Registered Polysomnographic Technologist (RPSGT) must be on staff to set up and troubleshoot PAP equipment; set up and troubleshoot oximetry equipment. The respiratory therapist service called for in this contract must be licensed to practice in Idaho, Oregon and Nevada. Proof of licensure must be provided to the BVAMC upon contract acceptance and yearly thereafter. The Contractor must provide proof of continuing education, training and competencies on an ongoing basis to the BVAMC.

B. The Contractor must provide and document employee orientation, ongoing employee education, current professional licensure and ongoing assessment of employee competency for all employees involved with the delivery/recovery of equipment covered under this contract according to Joint Commission Standards.

C. The Contractor will educate, evaluate and document employee education in strict accordance with current Joint Commission standards.

D. Only employees that have been properly trained and who have demonstrated competency may perform equipment deliveries, recoveries and patient education on the equipment. The contractor shall be staffed and have sufficient supplies to render satisfactory and courteous service at all times to the beneficiary. The Contractor shall be responsible for the acts and omissions of his/her employees, his/her sub-contractors or satellite offices and their employees. Sub-contractors are required to adhere to the requirements of this contract.

E. The Contractor must maintain their staff's competency training and make copies available of proof of training to the Government when requested.

F. The Contractor will have on file a current criminal background check for each employee assigned to the VA's contract and shall exercise due diligence to ensure safety of the patients being served.

4. Proof of Identification: Contractor's personnel shall bear identification when providing services or making deliveries to beneficiary's homes. Such identification will show the company name, employee's name and the employee's picture.

5. Payment and Invoicing: The contractor shall NOT charge patients or 3rd party payers any fees or surcharges for services rendered under this contract. If the contractor or facility Prosthetics & Sensory Aid Services (P&SAS) receives notice of any additional charges, the contractor shall fully cooperate with COR and Contracting Officer investigating such allegations and shall promptly refund any payment deemed improper by the Contracting Officer to the party who made the payment.

A. The contractor agrees to accept the Government purchase card for all payments under this contract. The vendor shall possess any necessary Level II equipment capable of showing the appropriate Purchase Order Number in each charge processed for payment. When the contractor charges the Government credit card, they shall include the Purchase Order Number assigned by the VA in the Level II data.

B. The contractor shall charge the appropriate purchase card, as instructed by the VA, AFTER services have been performed under the contract. Individual charges and individual invoices shall NOT include charges for more than 1 veteran. Invoices shall be submitted in an original form within five (5) business days after completion of services. Any invoice the vendor submits to the VA after five (5) business days will be subject to a 10% reduction in payment for each day the invoice is late.

C. Payment will be made in arrears, upon receipt of a properly prepared invoice.

D. Invoices shall contain the following information:

1. Name and address of contractor

2. Invoice Number and Date of Invoice

3. Contract Number

4. Purchase Order Number

5. Veteran’s name, address, telephone number and SSN

6. Date(s) services were rendered

7. Itemized list of services rendered (i.e., site assessment, items delivered, items picked-up and/or items repaired (including manufacturer, serial numbers, model numbers and size when applicable).

8. Copy of signed delivery receipt

E. The Department of Veterans Affairs Financial Service Center (FSC) is the designated agency office for invoice receipt in accordance with the Prompt Payment Act (5 CFR Part 1315). FSC or its designated representative may contact the vendor to provide specific instructions for electronic submission of invoices. The vendor shall be responsible for any associated expenses. FSC may utilize third-party contractors to facilitate invoice processing. Prior to contact by FSC or its designated representative for electronic invoicing submissions, the vendor shall continue to submit all invoices to FSC at the mailing address below:

Department of Veterans Affairs

Financial Services Center

P.O. Box 149971

Austin, TX 78714-8971

6. Facility: The Contractor's facilities shall meet the requirements of the solicitation as it relates to storage and provides a proper area for providing instructions to VA beneficiaries. The Contractor's facilities shall provide an environment that is safe and secure for VA beneficiaries seeking services required under this contract. The Contractor's facilities shall be accessible for persons with disabilities and be representative of the VA's good image in appearance and safety.

7. Unusual Conditions: The Contractor is required to notify the COR immediately if any of the following unusual conditions are known to exist concerning the beneficiary.

A. change in address

B. excessive abuse of equipment

C. request for additional equipment or accessories without the consent of the COR or PAP Coordinator

D. request for any change of the original prescription

E. unusual conditions in the beneficiary's residence

F. suspected abuse or neglect of beneficiary

8. Site Visits: Periodic, unscheduled on-site contractor and home PAP patient visits will be made by COR or designee to monitor the contractor's performance under this contract. The contractor agrees to make available all records and documentation necessary during the monitoring visits.

9. Experience: The Contractor must have at least two (2) years of experience in successfully administering basic PAP therapy/oximetry to adult and geriatric patients. The Contractor will be responsible for coordinating, supervising and evaluating the services provided.

10. Storage: The Contractor shall provide sufficient space for storage of equipment. The stored equipment must be maintained safe, clean, dry and in an orderly arrangement to prevent damage and to facilitate periodic inventory inspections by BVAMC officials. Storage space shall be separate and apart from all other contractor owned equipment and supplies and insured against loss or damage of contents.

A. Contaminated equipment shall be separated from clean equipment. The Contractor's warehouse shall have clear demarcation between contaminated and clean storage areas.

B. The storage space shall include a “clean” area for ready-to-issue VA equipment. This clean area shall be separated from the receiving, cleaning, disinfecting, sterilizing, sanitizing, repair and disposal areas of the facility, in accordance with JC guidelines. Contractor vehicles used in the performance of this contract shall also have segregated storage to allow for the transportation of both clean and unclean equipment, when needed.

C. The storage area must be climate controlled to protect equipment against deterioration caused by dust, moisture, and/or temperature extremes. The contractor shall ensure that the storage facility is bug free, rodent free, well lighted, and equipped with fire extinguishers. The area shall be free of all safety hazards. The area where VA property is to be stored shall contain clearly visible signs stating, “U.S. GOVERNMENT PROPERTY – NO TRESSPASSING”.

D. Before being placed in the contractor’s ready-to-issue storage area, all equipment shall be inspected for proper operation, serviceability and safety and will be thoroughly cleaned, disinfected, sanitized, sterilized, lubricated, repaired (if necessary), have preventive maintenance performed, and then be tagged and protectively wrapped in plastic. If equipment is picked up from the prior contractor or a VA facility, and the services noted in this paragraph have clearly been performed, then those processes would not need to be performed a second time.

E. The office and storage facility shall contain a sprinkler system and adequate heating.

F. Equipment awaiting repairs shall be tagged and separated from serviceable/repaired equipment.

G. The storage space shall be sufficiently insured against loss or damage equal to the value of the stored equipment. Proof of adequate insurance coverage shall be provided to the VA COR within 10 days after award of contract.

H. Any part of the contractor’s facility(s) that contain a veteran’s protected health information (i.e., social security number) shall be secured in accordance with HIPPA regulations and the Privacy Act.

11. Inventory: The Contractor shall maintain and furnish a monthly inventory of all VA owned equipment stored by the Contractor and include status of condition. The contractor shall also provide an inventory of all items issued to and picked up from beneficiaries by beneficiary name, address, and date of delivery and serial number if applicable, within five (5) business days of pick up. The Contractor must maintain an adequate bookkeeping system that will be made available to VA personnel conducting inspections and verifying inventory of equipment storage facilities. Contractor and COR will meet to agree with re-ordering points for all VA owned equipment. Contractor will immediately contact COTR once an item has reached the re-ordering point to avoid depletion of VA equipment.

12. Lost or Damaged Equipment: The BVAMC will not pay for the Contractor's lost or damaged equipment provided under this contract unless circumstances as reviewed by the Contracting Officer are concluded to be the results of willful negligence on behalf of patients or VA employees. Accordingly, this is considered to be the cost of doing business and is the requirement of the Contractor to pay for this type of equipment. Contractor may request payment by submitting a written summary of the circumstances of lost or damaged equipment to the contracting officer within thirty (30) calendar days of the occurrence of the incident in question. The Contracting Officer will review the summary, and a written determination will be made to the Contractor as to the liability. The VA will not pay for rental on equipment not being used by an authorized veteran during the performance of this contract or for equipment that cannot be found.

13. Infection Control: Standard precautions shall be used to prevent exposure to blood borne diseases when handling all contaminated equipment/items. Gloves shall be worn when handling items soiled with blood and/or body fluids. Hands shall be washed before and after visiting each patient and when gloves are removed. Contaminated equipment shall be bagged and separated from clean equipment. The Contractor's warehouse shall have clear demarcation between contaminated and clean storage areas. Delivery vehicles: if dirty and clean equipment is transported in the same vehicle, it will have a clearly demarcated area for clean and dirty items. Contractor's procedure for handling the pickup of dirty equipment will meet or exceed Joint Commission standards.

A. CDC hand hygiene guidelines shall be strictly followed. Hands shall be decontaminated before and after visiting each patient, and after removing gloves. Hands that are not visible soiled (or gloves that have been removed were not visibly soiled) may be decontaminated by using an alcohol hand rub. Hands that are visible soiled (or gloves that have been removed were visibly soiled) must be decontaminated by washing with antimicrobial soap and water for no less than 15 seconds.

B. The Contractor must have a current policy of the plan for surveillance, prevention and control of infection and make a copy available as part of the offeror's technical proposal. The plan must meet current Joint Commission Standards.

C. Contractor shall provide a list of names to the COR or designee of all veteran patients exposed to communicable diseases by contracted staff during an identified incubation period. The type of exposure will also be identified. The COR or designee will consult with VA infection control staff regarding the need to contact exposed patients and/or complete any needed medical follow-up.

D. Infection control reports will be sent to the COR on a semi-annual basis. Reports shall be due by the following dates: May 8th and November 8th. Failure to meet the required dates shall result in a 1% reduction for each day the report is late and applied to the monthly invoice.

14. Safety Requirements: At the time of set up and again during any follow-up home visits, the Contractor shall perform an assessment of the beneficiary's home and environment (to include falls assessment) in accordance with Joint Commission Standards and maintain documentation of assessments in the individual patient file or folder.

A. The Contractor shall check the safety of the electrical outlets in the beneficiary's home prior to installing any electrical item. Electrical outlets shall be inspected and tested to ensure that ground is present, and the outlet is in good physical condition. If any outlet is not grounded, a 3-prong plug adapter will be provided, installed and retested by the Contractor. It is the veteran's responsibility to have the appropriate electrical system in their residence. The BVAMC shall not be responsible for liable for any unsafe electrical conditions caused by the Contractor. Any alterations to the veteran's residence will be the responsibility of the veteran. Any unsafe electrical conditions will be immediately reported to the COR or designee by phone from the beneficiary's residence and the equipment will not be installed or left. The BVAMC will provide instructions on how to proceed.

B. All electrically powered equipment used in performance of this contract shall be UL approved and shall be current state of the art at the time of use.

C. The Contractor shall verbally notify the COR or designee by the next business day of any unsafe conditions observed in the beneficiary's home that preclude the installation or continuance of service. Unsafe conditions may include, but are not limited to: fire safety hazards, patient abuse by family or caregivers, unsanitary living conditions or any instance that places the patient or Contractor's staff in immediate danger. The Contractor shall furnish written documentation of the safety hazard to the COR or designee within two (2) business days of the incident.

15. Holidays: The services covered by the contract shall be furnished by the contractor as defined herein: At a minimum, Contractor will provide services through scheduled visits, Monday through Friday from 8:00 a.m. to 4:30 p.m.

The VA observes the ten (10) Federal holidays listed below.

New Year's Day

Labor Day

Martin Luther King's Birthday

Columbus Day

President's Day

Veteran's Day

Memorial Day

Thanksgiving Day

July 4th

Christmas Day

*It should be noted that if a holiday falls on a Saturday, it is observed on Friday. If a holiday falls on Sunday, it is observed on Monday. The Contractor is responsible for scheduling the appointments to the beneficiary's home 24-48 hours prior to the appointment.

16. Conflict of Interest: The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Department of Veterans Affairs unless such person seeks and receives approval in accordance with VA Regulations and public law. Nor shall the Contractor employ any person who is a member of the immediate family of a VA employee employed at the BVAMC if the employment of that family member would create a conflict of interest or the appearance of a conflict of interest, particularly with regard to influencing the contract negotiations, terms of the contract or the work carried out under the contract. In any such case, VA must review the matter and give its approval in accordance with agency ethics rules.

17. Failure to Respond: Failure of the contractor to respond to routine deliveries, or emergency service calls within 24 hours after notification by the VA may be considered grounds for invoking provisions of FAR 52.212-4 (m) "Termination for Cause."

18. Phase-in Requirements: The Contractor agrees to a maximum ninety (90) day transition period from the date the contract is awarded for the transferring of all services and supplies to VA beneficiaries. The Contractor shall coordinate transition efforts with the incumbent and VA (See FAR 52.237-3, Continuity of Services). Transition date of each beneficiary shall be noted, and billing period shall commence on that day.

19. Phase-Out Requirements: The Contractor recognizes that the services being provided under this contract are vital and must be continued uninterrupted if the Government elects not to exercise its option to extend the term of this contract or at contract expiration. The Contractor shall not remove any equipment from the beneficiary's residence until replacement equipment has been installed. If additional phase-in/phase-out time is required beyond contract expirations in accordance with FAR 52.237-3, the Contractor will be paid on a prorated basis at the prices established for the last period of performance.

20. Insurance Requirements:

A. The contractor agrees to procure and maintain, Workers Compensation and Employer's Public Liability Insurance in accordance with the laws of the state in which services are provided.

B. The Contractor shall comply with all applicable Federal and State laws with regard to liability arising or resulting from injury to death of an employee in performing the work under the contract, and shall save and hold the Government harmless against any or all loss, cost, damage, claim, expense or liability whatsoever, because of accident or injury to persons or property of others occurring during the performance of this contract. All liability coverage shall be kept current throughout the duration of the contract and current certifications provided to the Contracting Officer.

C. Before starting work under this contract, the Contracting Officer shall require the Contractor to furnish a certification from his insurance company that the coverage outlined in paragraph (a) and (b) has been obtained and that it may not be changed or canceled without written notice to the Contracting Officer.

21. Beneficiary Lists: Beneficiary lists, no matter how developed, shall be treated as CONFIDENTIAL information. Lists and/or names of beneficiaries shall NOT be disclosed or revealed for any use outside the BVAMC, without prior written permission of the VA. The VA database listing may NEVER be utilized for solicitation of any kind. Any correspondence to veterans MUST have prior approval and be signed by the Contractor and the VA.

22. Authorities: 45 CFR 164.506 Uses and disclosures to carry out treatment, payment, or health care operations.

23. HIPAA: The contractor will be given beneficiary information that may include Veteran’s name, place of residence address, telephone number, and social security number. Beneficiary information is confidential and is protected under the Privacy Act of 1974 and the Healthcare Insurance Portability and Accountability Act of 1996 (HIPAA) and should be destroyed in accordance with Federal Regulations. See FAR 52.224-1 and 52.224-2.

24. Privacy Training: Mandatory VA provided Privacy Training shall be completed by all contract employees and new contract employees within 30-days of starting work. VA provided Privacy Training will be completed annually by all contract employees until contract expiration. Any questions regarding Privacy may be directed to the VA Privacy Officer.

25. Release of Information: The Contract employee shall only release medical information obtained during the course of this contract to the BVAMC designated employee or staff involved in the care and treatment of that individual beneficiary. All other requests for release of beneficiary information must be handled by the BVAMC Release of Information Department.

26. Liquidated Damages for Data Breach:

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Page 26 of 57

Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least three (3) relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One (1) year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

12. FACSIMILIES: For all facsimile transmissions made under this contract, a facsimile cover sheet must be used, and the following statement must be included on said cover sheet:

“This fax is intended only for the use of the person or office to which it is addressed and may contain information that is privileged, confidential, or protected by law. All others are hereby notified that the receipt of this fax does not waive any applicable privilege or exemption for disclosure and that any dissemination, distribution, or copying of this communication is prohibited. If you have received this fax in error, please notify this office immediately at the telephone number listed above.”

26. Policies and Procedures: The VA will review the policies, procedures, and plans of the Contractor to identify and resolve variances. The VA and the Contractor shall collaborate to modify the Contractor policies, procedures and plans or use those of the VA. The Contractor shall maintain policies and procedures that meet or exceed Joint Commission Standards. The Contractor will provide the BVAMC with a copy of their policies/procedures at the initiation of the contract and yearly thereafter. The Contractor shall be responsible for the orientation and continuing education/training of all employees after initial orientation by the VA at contract award.

27. Performance Monitoring: In addition to the oximetry results mentioned above, the Contractor will provide written semi-annual reports meeting all Joint Commission standards for improving organizational performance. Reports shall be due by the following dates: 1st report due May 8th; 2nd report due November 8th. Failure to meet the required dates shall result in a 1% reduction for each day the report is late and applied to the monthly invoice.

A. Incident Report: reporting special incidents found or occurring during an office and or home visit, to include finding patients in need of emergency medical assistance, safety hazards that do not fall into the category of presenting immediate life-threatening danger to the veteran or Contractor's staff, inability to contact a veteran within a reasonable period of time, and any other incident meeting the Contractor's written policy for incident reporting according to accreditation standards. Incidents shall be reported to the COR in writing within two (2) business days.

B. Customer Satisfaction: In accordance with Joint Commission Standards, the Contractor will collect data on service satisfaction from contracted patients and their families from each facility on a quarterly basis. A copy of survey results will be submitted to COR or designee in the Quarterly report. Reports are due by the following dates: February 8th, June 8th, August 8th and November 8th. Failure to meet required dates shall result in above stated reduction on the monthly invoice.

C. Performance Improvement: The Contractor will collect data on important processes and outcomes related to patient care and organizational functions. Performance improvement reports will be sent to COR on a semi-annual basis. Reports will be due May 8th and November 8th. Failure to meet required dates shall result in above stated reduction on the monthly invoice.

28. Patient Safety Monitoring: The Contractor shall provide the following emergent patient safety reports in addition to verbal reporting requirements listed in each item below throughout the contract period. The Contractor will provide a copy of their patient incident report to the COR for approval. If the report is disapproved, the Contractor may be required to make changes to their form or utilize the BVAMC's incident reporting form.

A. Sentinel Events: The Contractor is required to inform the COR within one (1) business day of a sentinel event (as defined by the Joint Commission) that occurs during the performance of this contract that involves BVAMC beneficiaries.

B. Refusal of Service: All beneficiaries have the right to refuse service. In the event a beneficiary refuses service, the Contractor shall comply with the beneficiary's wishes. However, in addition to a written report, the Contractor shall report the specifics of the refusal to the COR or designee by fax or encrypted electronic means within two (2) business days. If the refusal occurs during a home visit, the Contractor's staff shall make an attempt to notify the COR or designee prior to leaving the home.

C. Neglect or Abuse: The Contractor shall report suspected incidents of abuse or neglect to the patient by family members or caregivers. Suspected incidents shall be reported immediately, within one (1) business day, to the COR as well as to the adult protective agency. The Contractor will follow all state and local laws in reporting suspected incidents of abuse or neglect.

D. Fall Prevention: The Contractor shall monitor and report any falls noted on home visits within forty-eight (48) hours to the COR or designee. The Contractor shall also provide a quarterly report of all falls and interventions.

29. Patient Files: The Contractor shall maintain a VA beneficiary account folder in compliance with the Privacy Act and Health Insurance Portability and Accountability Act (HIPPA). All beneficiary files are subject to review by designated BVAMC officials and accreditation surveyors on behalf of the BVAMC during accreditation surveys or consultation. As a minimum the VA beneficiary folder will adhere to current Joint Commission standards for patient record keeping. Any part of the contractor’s facility(s) that contain a veteran’s protected health information (i.e., social security number) shall be secured in accordance with HIPPA regulations and the Privacy Act.

30. Representative of Contracting Officer: The Contracting Officer reserves the right to designate a representative to act for him/her in furnishing technical guidance and advice or generally supervise the work to be performed under this contract. Such designation will be in writing and will define the scope and limitations of the designee's authority. A copy of the designation will be furnished to the Contractor after notice of award.

31. Qualifications of Offerors: Each branch office or distribution point must be nationally accredited and meet Joint Commission Standards.

A. Proof of such accreditation must be submitted to the BVAMC with technical proposal and by December 31 of every year thereafter.

B. Contractor must maintain accreditation throughout the duration of the contract. All prospective Contractors must include with their proposal documentation on how they have met the Joint Commission Standards.

C. The Contractor will notify the Contracting Officer of any change in accreditation status within 24 hours.

D. Any…