PWS for Dialsysis at VASNHCS Final.pdf

DIALYSIS SERVICES

Performance Work Statement

Dialysis and VA Sierra Nevada Health Care System

1. Scope of Work:

The contractor shall provide all personnel, transportation, and equipment (machines must have dialysis alarm) to perform inpatient/outpatient (unit’s such as Emergency Department and Community Living Center are considered “outpatient”) Hemodialysis treatment services to Veteran patients who are being cared for as inpatient(s)/outpatient(s) at VA Sierra Nevada Health Care System (VASNHCS). The contractor shall provide the necessary nurses and certified technicians who have certifications, experience, knowledge, abilities, and skills in operating a dialysis machine to provide hemodialysis, CRRT (continuous renal replacement therapy), apheresis, and PD (peritoneal dialysis) treatments to Veteran patients. Contractor shall maintain a minimum of five (5) Registered Nurses and three (3) Medical technicians fully credentialed by VASNHCS.

All services will be performed at VASNHCS in the ICU/Stepdown Unit, Medical/Surgical Ward, in the Dialysis Suite, ED (Emergency Department) or CLC (Community Living Center). The services will be performed at any time, 24 hours/7 days a week. The services will be coordinated by the staff nurse at VASNHCS. The payment of services shall be per patient, per treatment/procedure. The contractor dialysis nurse/certified technician will generally consult with the Charge Nurse, Staff Nephrologist or Chief of Medical Service at VASNHCS when unusual circumstances arise. VASNHCS will provide physician oversight services and retain ultimate authority over and responsibility for each patient’s care and treatment.

Also included in this contract, the contractor is to provide a liaison able to come on‐site on an ad hoc basis. An example of ad hoc basis may include during regulatory visits from the Joint Commission or Office of the Inspector General.

2. Specific Contractor Tasks include:

2.1. Perform all dialysis treatments that include Hemodialysis, CRRT, plasmapheresis, Apheresis, and PD with registered nurses/certified technicians in accordance with standard healthcare dialysis treatment procedure. Each nurse performing those services shall be responsible for the composition of the dialysate, administering IV solutions, blood and blood products including lab draws, and medications (as ordered by the VA attending physician) placed into the dialyzer blood line system necessary for inpatient/outpatient treatments. Contractor’s personnel shall be responsible for provision of the following ordered services:

Provide, set‐up and safety check of machine and water treatment system;

initiating treatment, monitoring of treatment, and termination of treatment;

provide hand‐off direct report, to the VA staff nurse for continuity of patient care; and cleaning and disinfection of dialysis equipment and proper storage of machine and supplies.

Any changes in the laws, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract.

2.2. Conduct all operator water testing and operator maintenance, including cleaning and disinfection of dialysis equipment. Contractor shall keep all water, cleaning and maintenance logs per regulatory compliance criteria. Contractor nurse shall be responsible for patient monitoring during the procedure.

2.2.1. Collect, process and test water specimens for bacterial growth, endotoxin, and heavy metal. The intervals for testing and the accepted level of water quality shall conform to AAMI standards.

2.2.2. The Contractor shall forward a copy of all water quality tests to the Infection Control Coordinator, Contracting Officer Representative (COR), and the Chief of Medicine Services or their designee at the VASNHCS. The Contractor shall be responsible, together with VA for any follow‐up action required by the results of the bacteriological or chemical testing. Provide copy of water report in Dialysis room, per

JCAHO.

2.3. Provide 24 hours per day, seven days per week coverage as necessary, including holidays. Normal operating hours 7am‐ 6pm Monday to Saturday, excluding holidays

2.3.1. Respond to the VA facility within four (4) hours of calls for emergent dialysis from the ordering VA physician; ready to begin dialysis treatment. Emergent care coverage is 24 hours per day, seven days per week.

2.4. Provide hand‐off report to the VA nurse for documentation of patient treatment.

As a minimum documentation shall include 1) start time and completion time of treatment, 2) labs, including all Hepatitis Panel, 3) vitals, 4) site used, 5) procedure and schedule for bacteriological and chemical water testing, 6) procedure and schedule to assure sterility and/or cleanliness of the equipment before each dialysis, and 7) infection control procedure for the prevention and control of hepatitis. Also include medications, significant findings, and others.

2.4.1. Maintain patient information and medical records, including results of test, and follow appropriate procedures to ensure that patient confidentiality rights are not violated in accordance with applicable state and federal confidentiality laws.

2.4.2. Contractor personnel shall be provided training by the VA in the use of the CPRS;

and document appropriately. See Paragraphs 6, 7, 8, and 9 below for additional information regarding medical records.

2.5. The Contractor shall designate in writing a coordinator who shall facilitate scheduling, problem solving and other communication needs related to this contract.

To facilitate an effective transition, the coordinator will work with the COR to process Contractor nurses into the facility. COR will then facilitate with human resources and VISN security office regarding personnel background/security check, fingerprinting, orientation, license verification, and employee health records. In order to comply with VA Directives, additional background checks and credentialing materials may be requested by the VA outside our current, standard credentialing materials listed in proposed addendum exhibit D. The Contractor is to keep 75% of their staff credentialed with the VA. The Contractor is to inform the VA of staffing changes to continue credentialing. The Contractor is to send monthly staffing report updates to the

COR.

2.6. Provide summary results each quarter of quality control data on all VA dialysis patients. Individual patient data shall be required more frequently as requested.

2.7. The contractor shall assure compliance with all relevant regulatory agencies and standards for their personnel, including but not limited to The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the State of Nevada for all dialysis services rendered under this contract. The contractor shall comply with the requirements of VA inspections, surveys and collaborate in correcting any noted deficiencies which may include, but is not limited to, VA Office of the Inspector General (OIG), The Joint Commission (TJC). The contractor shall be notified immediately of any changes to VA policies by the VA or The Joint Commission regarding delivery or charting of inpatient/outpatient dialysis treatments to ensure compliance with the new policy.

The contractor shall provider a letter of current accreditation to the COR and CO, upon award of contract and upon request, if applicable.

2.8 The standard of care provided by the contractor shall be equal to or greater than that provided by VASNHCS.

2.9. The contractor shall notify VASNHCS Charge Nurse and the physician for any situations wherein the services cannot be performed, including equipment problems, and any situations wherein there may be a concern about the patient’s care.

3. Qualifications.

The contractor shall be responsible for ensuring that each registered nurse providing services under this contract is fully trained and completely competent to perform the required services covered by this contract. The contractor will be responsible for the

Registered Nurses to maintain current Nevada licenses and shall be in good standing and practice with the standards of nursing care within the medical community. Copy of the competency record and completed training must be provided to VASNHCS. The Registered Nurses must have a Basic Life Support (BLS) certification. Documentation must be updated on an annual basis. Safety orientation will be completed for all contracted staff, while shadowing.

4. Specific VASNHCS Tasks.

4.1. Provide space for the Contractor to perform dialysis treatments at the VA facility.

4.2. Provide associated laboratory services.

4.3. Provide supplies necessary that are not provided by the Contractor as part of the treatment procedures, including blood and medications.

4.4. Safeguard and protect dialysis equipment and supplies owned by the Contractor while the equipment and supplies are on VA premises.

4.5. Provide patient information as requested by the Contractor that is reasonable and necessary in order to perform dialysis services.

4.6. Assume joint responsibility for any follow‐up action required as a result of the bacteriological or chemical testing of the water. See Paragraph 2.2.2 above.

4.7. A qualified VA physician will be responsible for selection of suitable treatment modality and dialysis setting for each patient. The charge nurse for the respective patient care location, shall be the contact person for clinical issues relating to nursing.

4.8. Provide unit safety orientation for Contractor personnel newly assigned. Safety orientation will be provided before being assigned to do treatment procedure.

4.9. A cancelled procedure charge will be paid at the rate listed in the Price Schedule for cancelled service when a call is cancelled and the Contractor incurs a cost as a result of cancelled Services.

4.10. A charge will be paid when same day service is requested after regular working hours and at any time on weekends and holidays at the rate listed in the Price Schedule.

Normal working hours will be 7:00am – 6:00pm. Any services performed before or after that time would be considered after hours, and the vendor would charge accordingly.

4.11. A nurse waiting time charge will be paid at the rate listed in the Price Schedule when initiation of services are delayed by the VA for more than 30 minutes with documentation for reason for the delay in CPRS.

5. Contractor Personnel Security Requirements ‐ Information Systems Access All contract employees will complete the PIV process.

5.1 Contractor Responsibilities. In order to conduct a background investigation, the Contractor shall submit the following required forms to the COR. These will eventually be submitted to the Human Resources Management Service (HR) for processing. This will include the requirements for fingerprinting and badge issuance.

5.1.1. VA Form 10‐2850a, Application for Nurse Positions

5.1.2. Optional Form 306, Declaration for Federal Employment

5.1.3 Optional Form 612, Optional form for Federal Employment

5.1.4 Electronic Fingerprint Verification OR FD 258, U.S. Department of Justice Fingerprint Applicant Chart

6. Access to and Safeguard of VA Information/Computer Systems

6.1. VA may provide contract personnel with access to Computerized Patient Records System (CPRS) and/or other general files maintained on VA computer systems via personalized VA access codes. These access codes are confidential and are to be protected by the end user. Sharing of these access codes or misuse of VA information/computer systems is a Federal crime and may result in criminal penalties.

When contract personnel no longer provides services to VA under the contract or no longer needs access to VA information systems, the Contractor shall immediately inform the COR so that the appropriate contract person’s access codes can be deactivated. The COR will be responsible for ensuring that such access codes are deactivated.

6.2. All contract personnel accessing CPRS, or any other VA information/computer system, will be required to complete the following VA training: Computer Security, Rules of Behavior, Privacy Act, and HIPAA annually and sign all applicable computer user agreements (e.g. Rules of Behavior) prior to accessing VA systems. The COR will be responsible for ensuring and documenting that this requirement is satisfied. Contract personnel shall maintain, access, release, and otherwise manage the information contained on VA information/computer systems in accordance with all VA/VHA security policies, applicable VA confidentiality statutes (Title 38 U.S.C. Section 5701 and Title 38 U.S.C Section 7332) and the respective regulations implementing these statutes, and Federal statutes and/or regulations applicable to Federal agency records. Copies of this information discussed in the aforementioned paragraphs can be provided to the Contractor and contract personnel upon request.

6.3. Contract personnel with access to VA information/computer systems shall take reasonable safeguards, both physical and electronic, to safeguard the information and prevent unauthorized disclosures. Should contract personnel know, or suspect, that VA information/computer security was compromised or that VA information was, or could possibly be, disclosed to an unauthorized party, contract personnel must immediately report such knowledge or suspicion to the COR, who will then immediately notify the appropriate VA officials.

6.4. The Contractor shall follow all of the previously mentioned statutes and respective regulations implementing these statutes as well as VA Directive 6504 ‐ Restrictions on Transmission, Transportation and Use of, and Access to VA Data Outside a VA Facility, VA Directive 6601 – Removable Storage Media, and any other VA/VHA policies and procedures governing the information discussed in this section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Information Security (see the Information Security Officer).

6.5. Any changes in the laws, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract.

7. Computerized Patient Records System (CPRS)

7.1. Contract personnel are required to provide information on the treatment procedure for all patients. This is provided to the VASNHCS staff which will be entered in the CPRS.

7.2. The staff Nephrologist will be responsible for ensuring and documenting that these requirements are satisfied. If information for documentation in is not properly provided, VA reserves the right to withhold payment to the Contractor until such records are properly documented.

8. Handling of Records

8.1. By performing services under this contract, the Contractor is considered part of the VA healthcare activity for purposes of the following statutes and respective regulations implementing these statutes: Title 5 U.S.C Section 552a (Privacy Act), Title 38 U.S.C.

Section 5701, Title 38 U.S.C. Section 5705, Title 38 U.S.C Section 7332, and Public Law 104‐191 (HIPAA). Contract personnel shall have access to patient medical records and general files only to the extent necessary to perform their contractual duties. Contract personnel shall only release medical information obtained during the course of this contract to those VA medical staff members involved in the necessary care and treatment of the individual patient in which the information pertains. Notwithstanding any other clause and/or provision of this contract, if a request for release or disclosure of information is not necessary for the care and treatment of an individual patient, the

Contractor and contract personnel shall not disclose any information contained in general files, patient records, and/or any other individually identifiable health information, including information and records generated by the Contractor in performance of this contract, except pursuant to explicit instruction and written approval from VA. For the purposes of this paragraph, instruction to disclose or copy such records and/or information may only be provided by the following: VA Regional Counsel and Chief, Health Information Management Service/Privacy Officer through the VA Contracting Officer. Violation of the aforementioned statutes may result in criminal and/or civil penalties.

8.2. Contract personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under the statues and implementing regulations previously mentioned in paragraph 6, above, shall not have access to the records unless absolutely necessary to perform their contractual duties. Any contract person who has access to the previously mentioned data and/or information must not disclose it to anyone, including other contract personnel not involved in the performance of the particular contractual duty for which access to this data and/or information was obtained.

8.3. Information or records accessed and/or created by the Contractor in the course of performing services under this contract are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law, regulations, and/or VA/VHA policy. The Contractor will not copy information contained in VA information systems, either by printing to paper or by copying to another digital format, without the explicit instruction and written approval from of the VA officials, except as is necessary to make single copies in the ordinary course of providing patient care. The Contractor will not commingle the data from VA information systems with information from other sources. Contractor shall report any unauthorized disclosure of VA information to the VA officials.

8.4. If this contract is terminated for any reason, the Contractor will provide VA with all individually identifiable VA patient treatment records or other information in its possession, as well as any copies made pursuant to paragraph 6 above, within seven (7) calendar days of the termination of this contract.

8.5. The Contractor shall follow all VA policies regarding the retention of records. As an alternative, the Contractor may deliver the records to VA for retention.

8.6. The Contractor shall follow all of the previously mentioned statutes and respective regulations implementing these statutes as well as VHA Handbook 1605.1 ‐ Privacy and Release of Information and any other VA/VHA policies and procedures governing the information discussed in this section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Health Information Management (see the Privacy Officer). All contract personnel with access to any of the previously mentioned records (electronic or paper) will be required to complete VHA Privacy Policy Training before accessing such record systems. This training must also be completed annually. The COR will be responsible for ensuring and documenting that this requirement is satisfied.

8.7. Any changes in the laws, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract.

8.8. VA has unrestricted access to the records generated by the contractor pursuant to this contract.

9. HIPAA Compliance

Under HIPAA Privacy and Security Rules, the Contractor providing services under this contract is considered to be a “covered entity,” and thus is not required to enter into a Business Associate Agreement with VA. However, the Contractor must observe Public Law 104‐191 and all respective regulations implementing this law while providing services under this contract.

10. Invoicing and Payment:

10.1. A record‐keeping system of the contractor’s services performed shall be established by VASNHCS. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor, and shall not exceed the amounts specified in the “Schedule of Supplies and Services” without written request and the written approval from the Contracting Officer.

10.2. Invoices rendered by the contractor to VASNHCS for services furnished under this agreement, will be invoiced in full for each month in which services were performed. All payments made under this contract will be made monthly in arrears in accordance with FAR Clause 52.212‐4. No advance payments will be authorized.

Invoices shall be electronically sent using the form OB10 e‐Invoice to the Department of Veterans Affairs, PO Box 149971 Financial Services Center, Austin, TX. For more information on how to send invoices electronically, visit http://www.fsc.va.gov.

10.3. Invoices submitted will show the dates of the services, patient, type of dialysis or service provided. All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the COR.

10.5. At a minimum, each invoice must contain the following: Purchase order number for services, patient name, dates and hours of services provided, unit price, and total cost of services provided, contract number, and remittance address. All invoices must include the name, title and phone number of person to be notified in the event of defective invoicing.

10.6. All invoices must be submitted for actual services performed by the contractor.

Invoices shall be submitted in accordance with, and at the prices specified in the continuation of SF Form 1449, Schedule of Supplies and Services of this agreement.

11. Quality Assurance and Contract Performance Monitoring:

11.1. In accordance with VA regulations, a record‐keeping system will be established and maintained by the COR to ensure contract compliance. The contractor will provide the quality assurance information during the joint oversight meeting with the contractor.

11.2. The contractor will provide copies of charge sheet with the patient information, date, etc. to be used for reconciliation with CPRS records, these in turn will be verified for certification of invoices by the COR for payment of services.

11.3. Contractor agrees to provide services which meet or exceed the standards as established by The Joint Commission and the Department of Veterans Affairs policies.

11.4. The services specified herein may be changed by mutual written agreement of the parties, in accordance with the terms and conditions set forth herein.

12. Safety Orientation:

12.1. Contractors who have not received a safety orientation shall be oriented to the VASNHCS, prior to providing services. Safety orientation will be properly documented, and VA Staff will assess the competency of the contract nurses.

13. Terms of the Agreement:

13.1. This agreement is effective for the period identified in the “Schedule of Supplies and Service” and is subject to the availability of VA funds. Services will not be performed by the contractor beyond the expiration date, unless specifically authorized to do so in writing by the Contracting Officer.

13.2. Contractor personnel performing services under this agreement will not be considered VASNHCS employees for any purpose. VA will not make payment for any holidays or leave including sick leave or any other benefits financial or other. In addition, the contractor shall be required to provide their own worker’s compensation, liability insurance, health examinations, income tax withholdings and social security payments.

14. Estimated Quantities:

The quantities of services and cost specified in this agreement are estimates, based upon the projected workload during the period of performance. VASNHCS will not be obligated to reimburse the contractor for any specified amount of services; but will be obligated to make payment for any services received in the quality and quantity as requested.

15. VASNHCS Responsibilities:

15.1. After award, the Contracting Officer will designate a VA employee as the Contracting Officer’s Representative (COR). The COR will be responsible for overseeing and directing the services to be performed by under this agreement.

15.2. Other necessary personnel for performance of the services at the VASNHCS, will be provided by the VASNHCS at levels mutually agreed upon which are compatible with the safety of patients and personnel and with quality medical care programming.

Adequate and appropriate support staff will be available to assist the contract nurses.

15.3. Other personnel and equipment necessary for the operation of the services provided will be provided by the VA at levels compatible with the safety of patients, staff, and quality medical care programming. In the event that the contractor deems that the staffing, facilities, equipment, supplies and/or ancillary services at the VASNHCS site are materially inadequate for the satisfactory performance of services, the contractor will so notify VASNHCS COR and the Contracting Officer in writing.

16. Emergency Health Services:

16.1 The VA will render emergency health services for an incapacitating injury or otherwise serious illness occurring while on duty. All services, to include wages earned during the period of initial medical evaluation provided by the VA, shall be reimbursed by the contractor. The contractor shall furnish the VA with the necessary injury/illness form(s) for reporting purposes. The VA for statistical and/or billing purposes will retain a copy of the complete form(s).

17. Infection Control Requirements:

17.1. Health Tests – Contractor attests that he/she has fulfilled all testing and screening requirements as described below prior to providing services at first duty shift.

Evaluations and tests shall be current within the past year, except as noted. At VA’s request, the contractor shall provide proof that all requirements are current and fully met as described, within 2 days of request.

18. Tuberculosis Screening and Testing ‐

18.1 For those with previous documented positive purified protein derivative (PPD) test results: All contractor personnel shall provide a note from their physician, dated within the past three months stating they are free of any signs and symptoms of tuberculosis.

This evaluation will be renewed annually.

18.2. For those with previously negative PPD skin test results: personnel shall provide proof of a negative reaction to PPD testing, performed in accordance with the latest CDC standards and CDHS/California Tuberculosis Controllers Association guidelines, with the past six (6) months. This test shall be renewed annually.

18.3. For PPD skin converters (a change from a previously negative skin test to positive;

defined as an increase in duration of 10mm or more within 2 years): An evaluation from their physician within 30 days of the positive test stating they are free from signs/symptoms of TB and indicating whether prophylactic treatment is indicated. If treatment is indicated, a note from the physician stating it was satisfactorily completed.

18.4. Rubella Testing ‐ All contractor personnel shall provide proof of immunization for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow‐up documentation provided to the COR.

18.5. Varicella (chicken pox) testing ‐. Provide a history' of varicella or, if unknown, results of a varicella antibody test; and if non‐immune, vaccination with varivax.

18.6. Hepatitis B (Hepatitis B‐Surface Antibody Titer).

18.7 The contractor will provide documentation of all their employees Hepatitis B vaccinations records.

18.8. Unvaccinated contractor employees will be offered Hepatitis B vaccine at no cost to the contractor. A signed consent or declination forms is required in the employee refuses vaccination.

18.9. COVID‐19 vaccine is required.

18.10. The contractor shall have completed basic life support (BLS) training.

19. OSHA Regulations ‐ Occupational Exposure to Blood Borne Pathogens:

19.1 Health Tests ‐ Contractor personnel shall provide, upon VASNHCS request to review, proof of the following tests within five (5) days prior to providing services. Tests shall be current within the past year.

19.2 Tuberculosis Testing ‐ All Contractor personnel shall provide proof of a negative reaction to purified protein derivative (PPD) testing. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

19.3 Rubella Testing ‐ All contractor personnel shall provide proof of immunization for measles, mumps, rubella or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization must be administered with follow‐up documentation to the COR.

19.4. OSHA regulation concerning occupational exposure to blood‐borne pathogens ‐ The contractor shall provide a generic self study training module to its personnel;

provide Hepatitis B vaccination series at no cost to its personnel who elect to receive it;

maintain and distribute an exposure determination and control plan to its personnel;

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

19.5. Contracted nurses shall receive training in universal precautions and blood borne pathogens, TB education, hazardous material management and life safety management (fire preparedness). Training will be provided prior to initial assignment, at annually thereafter and as needed.

19.6 VA will notify the contractor of any significant communicable disease exposures as appropriate. The contractor’s occupational health provider shall adhere to current CDC/HICPAC Guideline for “infection control” in health care personnel (AJIC 1998;

26:289‐354) for disease control. The contracting agency shall provide follow up documentation of employee’s clearance to return to the workplace prior to their return.

20. Identification, Parking, Smoking and VA Regulations:

20.1. Contractor personnel shall wear visible identification at all times while on the premises of any VA facility.

20.2. It is the responsibility of contractor personnel to park in the appropriate designated parking areas. Information on parking is available from VA Police. VA will not validate or make reimbursement for parking violations under any conditions.

20.3. Smoking is prohibited in any VASNHCS building and the surrounding grounds, including the parking lots. Smoking is permitted only in a designated shelter.

20.4. Intoxication, debilitation resulting from drug use, insubordination, theft, patient abuse, dereliction or negligence in performing directed tasks and possession of weapons is prohibited and grounds for immediate removal from VA facility. Enclosed containers, of any nature, are subject to search.

20.5. Violations of VA regulations may result in a citation answerable in the U.S.

Federal District Court, not a local district, state or municipal court.

End of Statement