36C26121Q0045 0001.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 7

36C261

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

Network Contracting Office (NCO) 21

5342 Dudley Blvd, Bldg 209

McClellan CA 95652-2609

36C261

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

Network Contracting Office (NCO) 21

3230 Peacekeeper Way, Bldg. 209

McClellan CA 95652-1012

To all Offerors/Bidders

36C26121Q0045

08-09-2021

X

See CONTINUATION Page

X 1

a. The purpose of this amendment is to revise the performance work statement and answer questions from interested vendors.

IMPORTANT: Vendor shall sign and acknowledge this amendment.

Joleo Dianala

Contracting Officer

See attached document: PWS Perfusionist Services (Rev 08-18-2021).

Solicitation 36C26121Q0045 Questions

Board Certified Perfusionist / Certified Autotransfusionist Services for VA Palo Alto Health Care System

1. On page 6 of PDF 36C26121Q0045, the estimated hours of service in 0001 is 1040 hours. We believe the estimate should be about 1,864 per year. The estimated hours of service in 0003 may be an overestimate and we believe the estimate should be about 100 hours. The estimate hours in 0004 for cancellations is only 5 and we believe the estimate should be 5-10.

a. The estimated hours are based on the highest number of procedures within the past three years. Due to the nature of the requirement, the Government cannot provide an exact number of hours for perfusion/autotransfuion services in any given year.

2. Reference: “2.9.2. The number of Board Certified Perfusionists / Certified Autotransfusionists required to be on site daily is 1-2 as defined in paragraph Hours of Operation of this section.”

We would like to suggest that we can put our time in perfusionist and time out per perfusionist on one timesheet and have a separate time sheet for procedures performed.

a. Thank you for your suggestion. The program office will take it into consideration.

3. In section 6.3.1.1 the solicitation states that the VA will not pay for work that exceeds hours specified in the contract. What happens when the estimates do not line up with actual work performed?

a. The Contracting Officer’s Representative (COR) will monitor the accrued hours over the period of performance of any task order awarded. If the COR requires additional hours after reviewing the accrued hours, the COR may submit a task order modification to add additional funding or submit a new task order request. If actual work performed is less than the estimated hours, the Government will de-obligate remaining funds.

4. Reference: “2.1.1. License: All licenses held by the personnel working on this contract shall be full and unrestricted license to the services covered by this contract issued in any State, Territory, or

Commonwealth of the United States or the District of Columbia. Contract personnel shall submit evidence of current, full and unrestricted licenses, registration, certification, and/or other relevant credentials for verification prior to appointment and throughout the employment process, as requested by the COR. Contractor is responsible for keeping the COR informed of anything that would adversely affect or otherwise limit their clinical privileges. Failure to meet this requirement may result in termination of the contract.”

Perfusionists are not licensed in the state of California. The perfusionists are certified by the Board of

Cardiovascular Perfusion.

a. Please submit the relevant credentials for verification.

5. Reference: 4.6.4.2. Measure: Qualifications of Key Personnel Performance Requirement: All contract

Perfusionists shall have current certification in accordance with American Board of Cardiovascular

Perfusion and maintain license, registration and/or certification. Autotransfusionist shall have only a certification as an Autotransfusionist. Standard: All Perfusionists/Autotransfusionist shall be certified and compliant with all certifications Acceptable Quality Level:100%meets Standards Surveillance

Method: Random Sampling of qualification documents Frequency: Annually” and 4.6.4.7. Measure:

Maintains licensing, registration, and certification Performance Requirement: Updated Licensing, registration and certification shall be provided as they are renewed. Licensing and registration information shall be kept current Standard: All licensing, registration(s) and certification(s) for contract personnel(s) shall be provided as they are renewed Licensing and registration information shall be kept current Acceptable Quality Level: 100% meets Standards Surveillance Method: Periodic

Inspection and Random Sampling Frequency: Annually.

Perfusionists are not licensed in the state of California. The perfusionists are certified by the Board of

Cardiovascular Perfusion.

a. Please submit the relevant credentials for verification.

6. Reference: “2.1.2. Board Certification: The contractor’s employees and any subcontractors shall have all licenses, permits, and certifications as required by law and this contract. All Perfusionists and

Autotransfusionist shall be certified with at least a minimum of ten (10) years of experience. All

Perfusionists shall be a graduate of an accredited Allied Health Education Program 36C26121Q0045

Page 13 of 91 School of Perfusion Technology and shall be certified by the American Board of

Cardiovascular Perfusion, demonstrate evidence of meeting continuing education requirements and shall have performed a minimum of 1000 clinical cases. Experience shall be demonstrated in the following areas: Open heart surgery, autotransfusion, heart lung machine, membrane oxygenation, etc.”

Why 10 years of experience? If we need to hire a new perfusionist, they may have less than 10 years.

If the perfusionist is good and is acceptable to both the Chief Cardiac Surgeon and the Perfusion

Group, why 10 years’ experience? There is a Perfusionist shortage across the USA. If we were to lose a perfusionist this may limit our ability to render service to the VAPAHCS.

a. Thank you for your input. See revised PWS.

7. Reference: “2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU)

Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the VAMC. Contract personnel(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credential’s office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract personnel(s).”

Perfusionists submit yearly updated proof of recertification by the American Board of Cardiovascular

Perfusion. The American Board of Cardiovascular Perfusion will only issue recertification with proof of Continuing Education Units. They are checked against the meeting agendas by the governing bodies. This has been sufficient proof of Continuing Education in the past. Can we continue by submitting our recertification which is also proof of Continuing Education?

a. Yes

8. Reference: “2.1.9. Conflict of Interest: The Contractor and all contract personnel(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 and fully outlined in response to the subject attachment in Section D of the solicitation document.”

What constitutes a conflict of interest? Does a past performance of providing Contracted Perfusion

Services to VAPAHCS create a conflict of interest?

a. Per VAAR 852.209-70, The term “organizational conflict of interest” means that because of other activities or relationships with other persons, a person is unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or the person has an unfair competitive advantage.

9. 2.1.11.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site referenced above to ensure that the proposed contract physician (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.

We do not employ Physicians but we will ensure that there are no Perfusionists or Autotransfusionists on the list. No current Perfusionists are Excluded Individuals of OIG.

a. Contractors shall ensure key personnel are not on the list of excluded individuals of OIG

10. Reference: “3.1.1. Work Schedule: Board Certified Perfusionist/Certified Autotransfusionist will be scheduled on an as needed basis. Services shall be available from the Contractor 24 hours per day, seven days per week, including weekends and federal holidays. Contractor must provide coverage for all required shifts, including nights, weekends, and holidays. Monday through Sunday, including federal holidays as outlined in 3.2 The Perfusionist/Autotransfusionist service is required for 1,040 hours per year on a Monday through Sunday, on an as needed basis to support these procedures and patients that are in the Intensive Care Unit requiring balloon pump/Extracorporeal Membrane

Oxygenation (ECMO) support. The requirement is for the contractor to provide 3 Board Certified

Perfusionists/Certified Autotransfusionist.One perfusionist FTEE will be used to support the emergency services as well as provide for coverage during vacation, illness, etc.”

Perfusionist/Autotransfusionist is required for a minimum of 1040 hours not limited to 1040.

a. To clarify, 1,040 hours for CLIN 0001 is an estimate and there is no required minimum number of hours.

11. Reference: 4.4.1.2. The Autotransfusionist is responsible to check the OR schedule daily for surgical procedures requiring Autotransfusionist services; coordinate scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain a record of such; assure a minimum of four complete sets of supplies for open heart and Autotransfusion cases are available at any given time; sets up and operates Autotransfusion pump for surgical procedures other than open heart. Also, generates a record during each surgical case to include the surgical time of the procedure and the amount of autotransfused blood given to Anesthesiology for delivery to the patient and;

handle breakdown of disposable within autotransfusion pump after completion of each procedure.”

And “5.3. The Autotransfusionist is responsible for coordinating scheduled periodic preventative maintenance and repair calls for VA owned equipment and maintain record as such; sets up and operates autotransfusion pump for surgical procedures other than open heart.”

The Biomedical Engineer is responsible for coordinating periodic Preventative Maintenance and repair calls of VA owned equipment. We notify the biomedical engineer and they have the P.O.s to contact and pay the for the maintenance and repairs of equipment. They keep a record of activity.

The operating room does not have space for 4 sets of open heart and autotransfusion disposables. We keep back up supplies for each procedure done which means that there are 2 sets of disposables to start the procedure. Logistics is responsible for maintaining a par amount of supplies.

a. Thank you for the input. See revised PWS.

12. 4.4.1.3. Reporting Information for Treatment: Access to the VA EHR shall be provided to the perfusionists/autotransfusionist, including the ability to printout a report of those services provided by the perfusionists/autotransfusionist. A detailed treatment plan which includes an initial assessment, recommended plan of treatment and expected outcomes will be 36C26121Q0045 Page 22 of 91 submitted within twenty-four hours of initiating treatment for entering into the patient's clinical record and at a minimum contain the following information: • Patient’s name and identification number • Treating Physician's name and telephone number for follow-up questions • Pertinent History

• Physical Findings • Summary of the Recommended Treatment Plan • Date treatment was initiated or is planned • Anticipated or actual date that treatment was completed • Follow-up

Recommendations/Results of the Treatment • Instructions given to the patient

We have cardiopulmonary pump records for bypass procedures, it includes the patient name, id number, medical history, pertinent laboratory values, allergies, blood type and date of birth. The perfusionist’s name, surgeon’s name and anesthesiologists name are included. The date and time of treatment are on the pump record. It is inappropriate for us to include the physicians phone number and we do not have follow up recommendations or results of treatment beyond lab values done during the procedure. These patients are under a physician’s care and we support the care that the physician is giving. We can not do any procedures without a physician. We do not give the patient instructions.

a. Thank you for the input. See revised PWS

13. 4.4.1.5. COMMUNICATING TEST RESULTS TO PROVIDERS AND PATIENTS: In accordance with VHA Directive 1088, Communicating Test Results to Providers and Patients, all test results requiring action must be communicated by the ordering provider, or designee, to patients no later than

7 calendar days from the date on which the results are available. For test results that require no action, results must be communicated by the ordering provider, or designee, to patients no later than 14 calendar days from the date on which the results are available. The Contractor shall provide the VA with the name, pager and telephone numbers of a LIP (physician, nurse practitioner, or physician assistant) at the Outpatient Site of Care to accept critical test results discovered on tests done by the

VA. For critical results, the LIP must respond back to the VA within thirty (30) minutes of the initial page or telephone call. The receiving LIP will document the results in the record and conduct a “read back” procedure to ensure accuracy of transmission and translation of all verbal results. The contractor shall determine a plan to fulfill critical test result procedures, per VA policy. VA will not be responsible for the failure of the Contractor to receive critically abnormal test results. Critical results must be reported to the clinician by the radiologist by telephone. Documentation of this notification, “who, when” must appear in the radiology report. For critical results that represent an imminent danger to the patient, the Contractor shall notify the patient immediately. See policy fill in with your local policy name and number in section D (attachments) for additional requirements regarding communication of test results. Mechanisms must be in-place to provide notification of test results for patients receiving care in accordance with VHA Directive 1088, Communicating Test

Results to Providers and Patients.

Perfusionists are not Radiologists.

a. Thank you for the input. See revised PWS

14. Reference: “4.6.4.4. Measure: Patient Access (A) Performance Requirement: Patient must receive treatment in a timely manner Standard: Perfusionists shall be onsite and available during all scheduled OR hours and within 30 minutes of the facility Acceptable Quality Level: 98%meets

Standards Surveillance Method: Periodic Inspection Frequency: Quarterly Removal from contract until such time the contract personnel(s) meet qualification standard” and “4.6.4.5. Measure: Patient

Access (B) Performance Requirement: Perfusionists/Autotransfusionist shall be available and be in location as needed to properly perform tasks as specified Standard: Perfusionists shall be onsite and available during all scheduled OR hours and within 30 minutes of the facility Acceptable Quality

Level:98%meets Standards Surveillance Method: Random Sampling of Time and Attendance Sheets

Frequency: Quarterly”

We have perfusionists who live 30 minutes away, to get dressed and into work when there is traffic, the perfusionist will arrive within about 45 minutes. Please consider revising “within 30 minutes of the facility” to “within 45 minutes of the facility”

a. The references above are hereby revised from 30 minutes to 45 minutes. The statement of availability and geographical location will also reflect 45 minutes instead of 30 minutes

(Reference: Submission Instructions on page 68).

15. 5.6.2. The contractor shall provide a written statement quarterly to the Chief, Surgical Service regarding a summary of performance. The report shall be submitted directly to the Contracting

Officer’s Representative who shall distribute to the appropriate parties. The report shall be submitted no later than the 10th calendar day of each month.

From past experience, we have submitted the perfusion timesheet to the surgeon for approval. Is this sufficient?

a. VAPAHCS will provide the contract personnel with access to a timesheet on a shared drive.

By completing the timesheet on the shared drive, the contractor will meet this requirement as the COR has access to the shared drive.

16. Reference: 6.2.1.5. Contractor’s physician(s)

For billing, do you want us to include the perfusionist names and hours worked by each perfusionist?

Note that we do not have physicians.

a. See revised PWS.

17. Could you please tell me if the Presolicitation posted as solicitation number 36C26121Q0045_0 will be a follow-on requirement to any work performed currently or in the past, or will this be a new requirement? If possible, can you please provide the most recent contract or task order number?

a. Solicitation 36C26121Q0045 is a follow-on requirement. The current contract is

36C26121C0012.

18. How many cases (not just hours) are anticipated per year for cardiac perfusion?

a. The price schedule is based on hours not cases.

19. How many cases (not just hours) are anticipated per year for non-cardiac autotransfusion?

a. The price schedule is based on hours not cases.

20. How many cases per year are concurrent for either type of procedure?

a. The price schedule is based on hours not cases.

21. Of the estimated 540 hours for after-hours, weekend, or emergent requirements, how many cases does this represent?

a. The price schedule is based on hours not cases.