36C24924Q0424.docx

SUBJECT*

Urology Cryoablation Services - 614 POP: 3/1/2025-2/28/2030

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

POINT OF CONTACT*

Contract Specialist Samantha Shackelford samantha.shackelford@va.gov No Phone Calls

PLACE OF PERFORMANCE

Lt. Col Luke Weathers Jr.

VA Medical Center

1030 Jefferson Avenue

Memphis TN

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

Sources Sought Notice

This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement.

Background: The Department of Veterans Affairs Medical Center, NCO 9 Network Contracting Office, on behalf of the Memphis VA Medical Center is conducting market research through this source sought notice to seek sources to identify potential experienced businesses that are capable of meeting the requirements per the draft Performance Work Statement below.

Purpose and Objectives: Your responses to the information requested will assist the Government in determining the appropriate acquisition method.

NAICS code: 621399 and sized standard is $10 million.

NOTE: Respondent claiming SDVOSB and VOSB status must be registered, and CVE verified in VetBiz Registry www.vetbiz.gov.

Project requirements:

The contractor shall provide cryosurgical equipment and all related cryosurgical disposable probes required to perform cryosurgical procedures, ultrasound equipment, and a technician trained in the services and operation of the CryoCare CS or Cryo 20 unit as required to perform targeted cryoablation of the prostate (TCAP) procedures for the treatment of localized adenocarcinoma of the prostate. The contractor shall make the CryoCare CS or Cryo 20 unit and technician available to the VAMC Surgical Service Urology Department in accordance with a schedule mutually agreed upon between the parties. The VA Nurse Liaison will contact the contractor with a schedule and provide approximately 3-4 weeks advance notice. In the event the facility requires the use of the Unit at an unforeseen time other than those scheduled, contractor will make every effort to provide the Unit to the facility upon 48 hours advance notice from facility personnel. A standby fee of 50% of the total cost of the procedure will be paid for any case not cancelled within 24 hours of advanced notice. Exception shall apply when two cases are scheduled for the same day and one case requires cancelling, no standby charges will be assessed.

Performance Location: Services shall be provided on site, Lt. Col Luke Weathers Jr., VA Medical Center, 1030 Jefferson Avenue, Memphis TN 38104

The Contractor shall propose a maximum of two (2) key personnel to be credentialed and be available for scheduling to meet the requirements of the contracts.

One FTE is defined by VA as a minimum of 80 hours every two weeks and does include holidays.

SEE ATTACHED PERFORMANCE OF WORK STATEMENT DRAFT

Anticipated period of performance: 03/01/2025 thru 02/28/2030.

Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

Other important considerations: Cite any other information that is necessary for potential respondents to understand the nature of the potential requirement or proposed acquisition.

Capability statement /information sought: Response to this announcement shall not to exceed 10 pages and should include the following information: (1) A tailored capability statement indicating the firm’s ability to provide a product and related services; (2) The respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., SDVOSB/VOSB, etc,) pursuant to the applicable NAICS code; (3) Information should be provided electronically in a Microsoft Word or Adobe PDF format.

Please e-mail your response with the above information to Samantha.Shackelford@va.gov Any question should be emailed to Samantha.Shackelford@va.gov and phone calls will not be answered-questions must be submitted by email.

“Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”

See attached document: Draft PWS.

PERFORMANCE WORK STATEMENT

1. GENERAL:

1. General Description/Scope of Work: The contractor shall provide to the Lt. Col Luke Weathers Jr., VA Medical Center, 1030 Jefferson Avenue, Memphis TN 38104 cryosurgical equipment and all related cryosurgical disposable probes required to perform cryosurgical procedures, ultrasound equipment, and a technician trained in the services and operation of the CryoCare CS or Cryo 20 unit as required to perform targeted cryoablation of the prostate (TCAP) procedures for the treatment of localized adenocarcinoma of the prostate.

2. Scope: The VA anticipates the award of a single contract on a firm, fixed price indefinite delivery/indefinite quantity basis for this solicitation.

3. Services Provided: The contractor shall make the CryoCare CS or Cryo 20 unit and technician available to the VAMC Surgical Service Urology Department in accordance with a schedule mutually agreed upon between the parties. The VA Nurse Liaison will contact the contractor with a schedule and provide approximately 3-4 weeks advance notice. In the event the facility requires the use of the Unit at an unforeseen time other than those scheduled, contractor will make every effort to provide the Unit to the facility upon 48 hours advance notice from facility personnel. A standby fee of 50% of the total cost of the procedure will be paid for any case not cancelled within 24 hours of advanced notice. Exception shall apply when two cases are scheduled for the same day and one case requires cancelling, no standby charges will be assessed.

a. The contracting technician, also known as a Clinical Applications Specialist shall be responsible for setting up the equipment, and will be responsible for the following criteria:

• Setting up of the Urethral Warming System

• Proper sterilization and decontamination of the cryosurgical Cryo probes and temperature probes, the holders and the ultrasound probe.

• Connect ultrasound probe to the cryosurgical system.

• Proper gas setup and power on sequence.

• Connect cryosurgical probe and temperature probe to the cryosurgical system.

• Enter patient information into the proper fields.

• Run pre-test for the cryosurgical probe.

• Adjust ultrasound imaging (sagital and transverse) for the best quality.

• Has knowledge of ultrasound functions.

• Properly will run mapping portions of the procedure unless dictated otherwise by the physician.

• Demonstrate the ability to add or delete probes when needed.

• Engage auto freeze or manual mode as needed.

• Store case information.

• Load printer paper.

• Print case information.

• Shut down and bleed the cryosurgical systems at termination of the case.

b. The technician is also responsible for:

1. Identification cryosurgical machine and use of console components.

2. Have knowledge of the parameters of Auto freeze treatment modes (target temperature and safety stops, etc).

3. Acknowledge adequate time for the urethral warmer to warm fluid.

4. Turning the power on and off on the cryosurgical machine.

5. Attaching the Argon regulators.

6. Attaching the Helium gauge.

7. Being able to connect the Argon supply line to the cryosurgical system.

8. Connecting the Helium supply line to the cryosurgical system.

9. Being able to connect the Cryoprobes to the back of the Cryocare system.

10. Being able to attach the temperature probes and label according to the anatomy.

11. Accomplishing the breakdown of equipment, bleed and shutdown the cryosurgical system.

12. Operating the Cryocare keypad.

13. Identifying disposable supplies necessary for cryosurgery.

14. Making sure the Cryoprobe holder is affixed to a sterile drape fixture.

15. Ensuring the Cryoprobe is tested prior to patient use.

16. Knowing that one Argon tank should be regulated at 3000 psi and the other at 3200 psi, another Argon tank is considered empty once it reaches less than 3000 psi.

17. Having a Helium tank ready to be used which will be supplied by the hospital.

18. Hooking up the helium tank and know that once it falls below 900 psi for 2500 psi tanks and below 3000 psi for 6000 psi tanks, it should be considered empty.

c. The technician supplied by the contractor must demonstrate the ability to:

1. Turn the fluid warmer and circulating pump power on and off.

2. Insert the heat exchanger cassette in the fluid warmer.

3. Connect urethral warming tubing to 1-liter bag of room temperature NACL or water.

4. Apply IV pressure cuff to fluid and maintain fluid between 100 mm Hg and 200 mm Hg.

5. Install tubing into circulating pump with proper placement of tubing between “A” and “B” indicators.

6. Prime tubing after opening all clamps and turn pump speed at “2”, ensuring that all air bubbles are removed for proper priming.

7. Increase circulating pump speed to “3” and confirm with physician.

8. Set temperature to 37.5° C and verify temperature of fluid warmer with physician.

9. Increase and decrease temperature on fluid warmer.

10. Monitor the urethral warming system during cryosurgical procedure by:

a. Observation of paddle wheel spinning.

b. Ensuring consistent fluid level in IV bag.

c. Consistent temperature of fluid warmer.

11. Knowing that if a leak does occur, notify physician immediately and replace the urethral warming catheter, or any or all components of tubing set as necessary.

12. After removal, the urethral catheter, tubing, warming cassette, and fluid bag should be discarded in designated hospital container.

13. Instructions provided to scrub nurse for handling urethral catheter and tubing:

14. Handing off two distal ends of catheter tubing and separate spike tubing.

15. Securing tubing to OR field.

The remainder of the case and the actual performance of the targeted cryoablation of the prostate cancer will be performed by a VA licensed Urologic Physician.

d. The Contractor shall provide the following supplies:

• Cryoablation System

• Transrectal Ultrasound probe

• Argon & Helium regulator set

• Stepper (check bed for compatibility)

• Urethral warmer

• Grid

• Probe Holder

• Ultrasound Machine (renal)

• Laparoscopic or intra-operative US probe (renal)

• Cryosurgery Technician

• Disposables Prostate: CRYO-207V Prostate Kit and CRYO-77 Warming Cartridge Renal: CVA2400 Cryoprobes and CRYO-55 Temperature Probes

e. Memphis VAMC shall provide the following supplies:

• Gas requirements for the Cryocare

• ARGON: 99.998 pure or better 6000 PSI (grade 4.8 or better) Fitting: CGA677

• HELIUM: 99.995 pure or better 6000 PSI (industrial grade or better) Fitting: CGA677

• Gas: per prostate procedure – Hospital should order all gases and have on-site 5 days prior to cases

• 1 Tank Argon (Grade 4.8 – 99.998% Pure - 6000 PSI)

• 1 Tank Helium (6000 PSI)

• A back up of 1 Argon and 1 Helium should be on hand for each prostate procedure INSTRUMENTATION (Prostate) 1 ea. Hyperthermia Unit with upper body pad (Bair Hugger) 1 ea. Bowl set (1 large, 1 med., 1 small) 1 pair Allen Stirrups, Yellow Fins, Candy cane w/ padding 1 ea. Pressure bag for urethral warming system fluid 1 ea. Flexible Cystoscopy set 1 ea. Light source 1 ea. Video Set Up Minor Tray 6 ea. Hemostats 2 ea. Kelly 3 ea. Allis 2 ea. Std. Mayo (scissors) 1 ea. Short Needle Holder 2 ea. Tissue Forceps with teeth Suture 1 ea. Blade holder 4 ea. Towel clamps Drugs / Irrigation:

1 ea. 1-liter saline or H2O bag (double port at base) for warmer 3 ea. 1-liter saline bottles (Heated) on table 1 ea. 1-liter water bottles for probe testing 1 ea. Saline bag for Cysto Drapes:

1 ea. Cysto pack 1 ea. Mayo stand cover 1 ea. 3/4 sheet (under Buttocks) 1 ea. Back table cover Disposables:

1 pair Ted Hose, SCD’s 2 Tubes KY jelly 2 ea. 10cc syringe 1 ea. 6Occ syringe (luer lock) 1 ea. 6Occ syringe (toomey) 1 ea. 18fr or 20fr Foley with balloon 1 ea. Amplatz Super Stiff Guidewire, .035 or .038.

1 pk. 4 X 4 1 pk. Towels 1 ea. Perineal prep. Kit 1 ea. Cysto tubing 1 ea. Microtek Sterile endocavity transducer cover PC3688 (prostate) Instrumentation Renal Set up as partial laparoscopic nephrectomy unless Surgery is specified as “open” Disposables:

2 ea. FloSeal or comparable hemostasis product (do not open) 1 ea. Civco Sterile laparoscopic transducer cover 610-941 (renal)

f. Maintenance of Unit: Contractor shall provide service and preventive maintenance of the Unit.

Preventive maintenance shall include the performance of reasonable tests to ensure that the Unit is in the highest- level working condition. Vendor must supply Preventive maintenance documentation to Biomedical Engineering prior to first use.

g. QUALITY ASSURANCE: • Contractor shall ensure that contract technician(s) contribute to the ongoing quality improvement programs in the organization as described in Medical Center Memorandum No. 00-12, Quality Management System may be accessed at the following URL:

http://vaww.memphis.va.gov/docs/memo.aspx

4. Reusable Medical Equipment:

A. Definitions

(1) Reusable Medical Equipment (RME). RME is any medical equipment designed by the manufacturer to be reused for multiple patients. All RME must be accompanied by reprocessing instructions provided by the manufacturer.

(2) Standard Procedure. A document detailing all steps and activities of process or procedure that is dates and signed by the appropriate company official.

(3) Reprocessing. Reprocessing is the cleaning, disinfection, sterilization, and preparation of equipment to full readiness for its subsequent use.

(4) Set-up. Set-up is the process of assembling the RME in preparation for a procedure in accordance with the manufacturer’s instructions.

(5) Competency. Competency is the assurance that an individual has receives the appropriate training and has demonstrated an achieved skill level required to independently and appropriately perform an assigned task or responsibility.

B. Contractor Responsibilities

(1) Contractor and its representatives shall be responsible to ensure that RME systematic processes are fully implemented and executed at contractor locations providing services under this contract. Contractor shall ensure that appropriate training is provided and completed for all users of RME prior to initial use.

(2) All contractor personnel that are in any way involved in the set-up, use and reprocessing of RME shall have documented training on the setup, use, reprocessing, and maintenance of the specific equipment leading to initial competency and validation of that competency on an annual basis.

(3) All contractor personnel charged with reprocessing duties shall be appropriately trained and competent in performing the assigned task, and when procedures are changes all designated staff are retrained and competency is again established. Personnel reprocessing RMF must be continually evaluated to ensure that they are demonstrating proficiency in all reprocessing activities. Appropriate training must be done whenever new or different equipment is used.

Contractor shall provide evidence of training and competencies to the VA COR.

(4) Contractor shall have established, or establish for this contract, specific standard processes and procedures for all RME. This includes, but is not limited to following specific guidance regarding the use and reprocessing of RME:

(a) All clinical and technical personnel involved in RME set-up, use and reprocessing are to be trained in standard infection control methods, including those to protect both patients and themselves.

(b) Standard Procedures must reflect current manufacturers’ instructions and must be available in each area where reprocessing occurs for each type of RME used. Personnel assigned to reprocess RME must be trained according to device-specific procedures in order to ensure proper cleaning and high-level disinfection and sterilization.

(c) All standard procedures must be kept up-to-date according to the manufacture’s instructions, and methods in place to sequester outdated versions and to disseminate revised procedures, as well as to ensure compliance and competence in the execution of any revised procedure.

(d) Current manufacturer’s instruction for RME are available and on file.

(e) A method shall be in place to identify that a given RME has been reprocesses; if not clearly identifies as having been done, it must be reprocessed before use. A system or log shall be in place to record, for each instance of use, the:

i. Serial number, or other unique identifier, of the endoscopic equipment used for each patient procedure.

ii. Specific procedure, operator(s), date and time, and patient identifier.

(f) A quality management program must be in place to ensure appropriate and safe reprocessing is being performed.

C. References

(1) VHA Directive 2009-004, Use and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities, dated February 9, 2009

(2) VHA Directive 2009-031, Improving Safety in the Use of Reusable Medical Equipment Through Standardization of Organizational Structure and Reprocessing Requirements, dated June 26, 2009.

2.QUALIFICATIONS:

a. Staff/Facility

i. License/Certification – The Contractor will ensure that the contractor technician(s) possess all licenses, certifications, competencies required to perform the services covered by this contract.

ii. Technical Proficiency - Contractor’s technicians(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR 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 including any gaps in educational history for all Contractor’s technician(s). Contractor’s technician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

iii. Training (ACLS, BLS, CPRS 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 technician(s) as required by the VA

Training

Contract technician(s) must complete the "VA Privacy and Information Security Awareness and Rules of Behavior," (10176) and “VHA HIPAA Focused Training.” (10203) This training is a web-based course that may be accessed on the Talent Management System (TMS) https://www.tms.va.gov/SecureAuth35/. A copy of the training certificate must be forwarded to the Surgical Service COR who will in turn forward to VA Information Security Officers and Privacy Officer. This is an annual mandatory requirement.

The Contractor shall provide to the contracting officer a copy of the training certificates for each applicable technician within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete this mandatory training within the timeframe required will be grounds for suspension or termination of all physical and/or electronic access privileges and removal from work on the contract until such time as the training is completed.

iv. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for technician(s) within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year.

1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all Contractor’s technician(s). A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually.

2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor technician(s). {This is applicable to all health care workers}.

3. VARICELLA: Contractors shall provide proof of immunity for all Contractor technician(s). {This is applicable to all health care workers}.

4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor technician(s) {This is applicable to all health care workers}

5. INFLUENZA: Contractors shall provide proof that all Contractor technician(s) have received the annual Influenza vaccine unless it is contraindicated.

6. COVID-19: Contractors shall comply with VHA Supplemental Contract Requirements for Combatting COVID-19 (This is applicable to all health care workers).

7. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide generic self-study training for all Contractor’s technician(s); provide their own Hepatitis B vaccination series at no cost to the VA if they elect to receive it; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident. 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.

8. 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.

v. 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). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

vi. DEA - Contractor shall provide copy of current DEA certificate.

vii. Conflict of Interest: The Contractor and all Contractor’s technician(s) 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 Section D of the solicitation document.

viii. Citizenship related Requirements:

1. The Contractor certifies that the Contractor’s technician(s) 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 the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN patient referrals;

2. While performing services for the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN, 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.

3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN 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 Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Lt. Col. Luke Weathers Jr., VA Medical Center, Memphis TN; and shall form the basis for termination of this contract for breach.

4. 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.

5. 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.

1.1.1. 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.

6. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG website at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed Contractor’s technician(s) 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.

7. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

b. Clinical/Professional Performance: The qualifications of Contractor’s technician(s) are subject to review by VA Medical Center COS 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.

c. Non-Personal Healthcare Services: The parties agree that the Contractor and all Contractor’s technician(s) shall not be considered VA employees for any purpose.

d. 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.

e. Prohibition against Self-Referral: Contractor’s technician(s) are prohibited from referring VA patients to contractor’s or their own practice(s).

f. Inherent Government Functions: Contractor and Contractor’s technician(s) 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.

g. No Employee status: The Contractor shall be responsible for protecting Contractor’s technician(s) 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:

i. Workers’ compensation

ii. Professional liability insurance

iii. Health examinations

iv. Income tax withholding, and

v. Social security payments.

The parties agree that the Contractor, its employees, agents and subcontractors shall not be considered VA employees for any purpose.

VA employees for any purpose.

h. Tort Liability: The Federal Tort Claims Act does not cover Contractor or Contractor’s technician(s). When a Contractor or Contractor’s technician(s) 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 technician(s) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

i. Key Personnel:

i. The VA Full Time Equivalency (FTE) 1.0 FTE. No FTE is required for this service. FTE is defined by VA as a minimum of 80 hours every two weeks and does not include holidays.

3.VA HOURS OF OPERATION/SCHEDULING:

j. VA Business Hours: Operating Room Hours shall be scheduled during normal VA operating hours which are Monday through Friday, 8:00 AM to 4:30 PM.

i. The VA will schedule patients as services are needed. Contractor shall notify the COR at least monthly about any obstacles to meeting this performance measure.

k. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· 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 by the President of the United States to be a national holiday.

l. Cancellations:

i. Unless a state of emergency has been declared, the Contractor technician(s) shall be responsible for providing services.

4. CONTRACTOR RESPONSIBILITIES

a. Clinical Personnel Required: The Contractor shall provide Contractor’s technician(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

i. Contractor’s technician (s)shall be responsible for signing in and out when in attendance. Time sheets will be used by the COR to confirm hours/day and services provided against the contractor’s invoices.

ii. Standards of Care: The Contractor’s technician(s) shall perform Urology cryoablation services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding currently recognized TJC, VA and national standards as established by:

b. MEDICAL RECORDS

i. Authorities: Contractor’s technician (s) 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). Its employees, agents, and subcontractors will not be considered employees of the VA. Notwithstanding any other provision of this agreement, contractor and/or its employees may not disclose information contained in general files and patient records and any or other individually identified patient information, including information and records generated by the contractor in performance of this agreement, except pursuant to explicit instructions from the VA. For the purposes of this paragraph, instruction to disclose may be provided by these officials only: Contracting Officer, Contracting Officer Technical Advisor, the Privacy Officer, or VA attorneys. In responding to enrolled patient’s, release of information request the contractor shall supply a blank VA Form 10-4553 or 10-4553a to the enrolled patient and inform them to complete the form and mail it to VAMC Memphis. Release of Information consent is not required to transfer medical information between the contractor and the VAMC, Memphis, TN.

ii. 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, and policy. Contractor shall take steps to ensure that access is limited to those employees who need access to the data to perform the contract. Contractor shall not copy information contained in the system, either by printing to paper or by copying to another digital format, without the express permission of one of the officials listed in paragraph 4.4.1., above, except as is necessary to make single copies in the ordinary course of providing patient care. Contractor shall not commingle the data from the system with information from other sources. Contractor shall report any unauthorized disclosure of VA Information to the facility Privacy Officer. 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.

iii. Disclosure: Contractor’s technician(s) may have access to patient medical records: however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to 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. Contractors’ technician(s) are not to take any VA sensitive information off station. The VA will provide the Contractor with a copy of VHA Handbook 1907.1, Health Information management and Health Records and VHA Handbook 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure or removal of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

iv. 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: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 and all guidelines provided by the VAMC.

v. 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.

vi. External Peer Review Program: The contract technician (s) shall document in the medical record preventive health case management measures and the chronic disease indicators of the enrolled patient through the use of clinical reminders in CPRS. The Contractor's medical records will be made available for audit through the VAMC, Memphis, TN’s External Peer Review Program (EPRP). EPRP is provided to the VAMC, Memphis, TN by the contractor. Contractors who are seeing Department of Veterans Affairs patients are considered to be the VA providers and as such are provided access to confidential patient information as contained in the medical record. (Medical Center Memorandum 00- 75 (Peer Review for Quality Management) may be accessed at the following URL: http://vaww.memphis.va.gov/viewpublicfile.aspx?did=MKAViD/STE=

vii. Management for Medical Records: National Archives and Records Administration record disposition requirements are found in RCS 10-1 Chapter 6, 6000 series.

c. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT(QI)

i. The Contractor shall furnish the Chief of Staff, on an annual basis, provider-specific information on all contractor technician(s) providing services at the facility. This information shall be furnished using Proficiency Report Form 10-2623a, which will be provided to the contractor by the VA. This confidential, provider-specific information shall be used to identify opportunities for improvement.

ii. Patient Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The CO is final authority on validating complaints. In the event that the Contractor is involved and named in a validated patient complaint, the Government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

iii. The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, 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 directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s technician(s) conduct. The final arbiter on questions of acceptability is the CO.

iv. Performance Standards:

1. Measure: Timely Delivery of Supplies Performance Requirement: Supplies and equipment used to aid physicians in performing surgeries must be received in a timely manner as agreed.

Standard: Supplies and equipment to be delivered, functioning and available on date as scheduled 100% of the time.

Acceptable Quality Level: 99% meet Standards Surveillance Method: Direct Observation.

2. Measure: Qualification of Trained Technician(s) Performance Requirement: All Contractor’s technician(s) shall be qualified in accordance with the requirements of the PWS.

Standard: Qualified trained technician(s) shall be available and in location as needed to properly perform task as specified in PWS 100% of the time.

Acceptable Quality Level: 99%.

Surveillance Method: Random Inspection of qualification documents

3. Measure: Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information kept current.

Standard: All (100%) licensing, registration(s) and certification(s) for Contractor’s technician (s) shall be provided as they are renewed. Licensing and registration information kept current.

Acceptable Quality Level: 99% licensing, registration(s) and certification(s) for Contractor’s technician (s) shall be provided as they are renewed. Licensing and registration information kept current.

Surveillance Method: Periodic Review

4. Measure: Mandatory Training Performance Requirement: Contractor shall complete all required training on time per VAMC policy Standard: All (100%) of required training is complete on time by Contractor’s technician (s).

Acceptable Quality Level: 99% completions, no deviations Surveillance Method: Periodic Sampling

5. Measure: Privacy, Confidentiality and HIPAA Performance Requirement: Contractor is aware of all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA and complies with all standards, zero breaches of privacy or confidentiality.

Standard: All (100%) Contractor’s technician (s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Acceptable Quality Level: 100% compliance, no deviations Surveillance Method: Periodic Sampling; Contractor shall provide evidence of annual training required by VAMC, reports violations per VA Directive 6500.6.

v. Registration with Contractor Performance Assessment Reporting System

1. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates Contractor past performance on all contracts that exceed the simplified acquisition threshold and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, New Hampshire. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for Contractor responsibility determination information.

2. Each Contractor whose contract award is estimated to exceed the simplified acquisition threshold requires a CPARS evaluation. A government Focal Point will register your contract within thirty days after contract award and, at that time, you will receive an email message with a User ID (to be used when reviewing evaluations). Additional information regarding the evaluation process can be found at www.cpars.gov or if you have any questions, you may contact the Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690.

3. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the Contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the Contractor’s designated representative for comment. The Contractor representative will have sixty (60) days to submit any comments and re-assign the report to the CO.

4. Failure for the Contractor’s representative to respond to the evaluation within those sixty (60) days, will result in the Government’s evaluation being placed on file in the database with a statement that the Contractor failed to respond; the Contractor’s representative will be “locked out” of the evaluation and may no longer send comments.

5. GOVERNMENT RESPONSIBILITIES

a. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to: (enter contract administration if not already listed in another area- list the title (not name) and contact information for COR, Clinical point of contact, and any other relevant personnel involved).

i. CO RESPONSIBILITIES:

1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, including but not limited to a targeted and time-limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

ii. COR Responsibilities:

1. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the…