Amendment 0002 36C24222Q0821 s.pdf

AMENDMENT TO RFQ 36C24222Q0821 0002 Description: Extend Offer Due dates, Update Schedule, and provide Clarifications and Responses

Network Contracting Office 02, intents to submit a Request for Quote (RFQ) for certified Diagnostic Medical Physicist support services to conduct Diagnostic Imaging and Nuclear Medicine testing and audits for existing equipment (Radiographic, Fluoroscopic, and Computed Tomography (CT)) on behalf of the Department of Veterans Affairs Bronx VAMC . Contracting has been approved to solicit to all Small Businesses. The RFQ was issued on 06/27/2022. The government intends to award to a fixed price contract in accordance with all terms, conditions, provisions, and specifications of the solicitation.

The period of performance is October 1, 2022 (or date of award) through September 30, 2027. The schedule will consist of four additional ordering periods, resulting in Task Orders issued each year deemed funding is available. The solicitation included instructions to contractors about the offer submission process. In accordance with FAR 52.204-7, System for Award Management, prospective contractors must be registered in System for Award Management (SAM) to be eligible for award;

contractors may obtain SAM information at https://www.sam.gov. The applicable NAICS Code is 541690 Other Scientific and Technical Consulting Services with a Small Business Size Standard of $16.5 million.

The PSC is H165. All offerors are responsible for downloading all documents including amendments at the Federal Business Opportunities website without further notification from the Contracting Officer.

Place of Performance:

Department of Veterans Affairs James J. Peters VA Medical Center 130 West Kingbridge Road Bronx New York 10468

General Description of Services:

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site certified Diagnostic Medical Physicist support services to conduct Diagnostic Imaging and Nuclear Medicine testing and audits for existing equipment (Radiographic, Fluoroscopic, and Computed Tomography (CT)). All services will be under the direct supervision of a Board-Certified Medical Physicist. The FDA, and New York State Department of Health require testing of diagnostic x-ray equipment to ensure diagnostic imaging quality, and a safe environment of radiation safety for patients, staff, and visitors. The VA requires that these requirements be satisfied. Contractor shall offer a diverse, multi-modality experienced team of qualified Diagnostic Medical Physicist professionals. In addition, the Certified Diagnostic Medical Physicists is required to complete monitoring and reporting related to Radiation Safety Program. This procurement is being conducted under FAR Part 12 Commercial Items and FAR Part 13 Simplified Acquisitions.

https://www.sam.gov/

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)

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Department of Veterans Affairs Network Contracting Office 02 1304 Buckley Road Suite 101 Syracuse NY 13212

Department of Veterans Affairs Network Contracting Office 02 1304 Buckley Road Suite 101 Syracuse NY 13212

To all Offerors/Bidders

36C24222Q0821

X x

Extend to 08/01/2022 4:30pm Est.

X 1

This solicitation is IAW FAR Part 12, 13 and 19 for Board Certified Diagnostic Medical Physicist services for equipment testing and annual inspections requested for the Department of Veteran Affairs, James J. Peterson Medical Center. All services shall be conducted onsite at the Bronx VAMC .

1.The purpose of this modification is to extend the Offer Due Date from 07/26/2022 to the new date of 08/01/2022 as as stated in Section 11.

2. Updated Schedule of Healthcare Services. Offers may adjust quotes that have been previously submitted and resubmit a new quote for evaluation. Sections within the PWS have been updated.

3. Clarifications for Offerors for reference, see attached responses.

4. A signed copy of this amendment is required to be returned with quote submissions by Offerors.

Kathleen Sciortino Contracting Officer

VA-VHA-SAOC-2019-1257353F

CONTINUATION PAGE

SCHEDULE OF HEALTHCARE RESOURCES UPDATES

Section B.2 Schedule of Healthcare Resources has been updated. Line-Item Operating Room 0001d, 1001d, 2001d, 3001d, and 4001d Quantity and Unit of Issue for each period of performance was updated from 1 QTY to 4 and the Unit of Issue from Job to Quarter. See attachments for revised schedule.

Section B.2 Schedule of Healthcare Resources has been updated. Line-Item Board Certified Medical Physicists Room 0001g, 1001g, 2001g, 3001g, and 4001g description and estimated quantity for each period of performance was updated to the following:

Line-Item Description: Board-Certified Medical Physicists assistant to RSO Duties that include annual Radiation Safety training requirements identified under section 2.10.8

Line-Item Estimated Quantity: 20 hours was updated to 50 estimated hours.

PWS UPDATES:

Section 2.7.2. updated too:

For temporary substitutions where the key person shall not be reporting to work when required for services, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person requested to perform services IAW the Schedule of Healthcare Resources

Section 2.9.2. was removed. Section 2.16.1.1 added verbiage: . Reports shall be submitted upon completion either electronically and/or hardcopy.

Section 2.10.3.11 updated too: The contracted Certified Diagnostic Medical Physicist (s) agrees to perform applicable testing required by The Joint Commission and reports will demonstrate The Joint Commission verbiage.

Section 2.10.8 updated too: Radiation Safety Training for the Bronx VAMC Radiation Staff will be provided by the Certified Diagnostic Medical Physicists during the times from 8:00 am to 4:00 pm annually to go over radiation safety. Coordination’s shall be made with radiation safety supervisors and COR. All training shall be conducted onsite and in person by the Contractor. The training will be for all affected services as needed.

Section 2.10.9 has been added to the PWS. Section 2.10.9. reads: According to JJP VAMC Continuity of Operation Plan for RSO coverage, PM 11-184, a temporary RSO coverage for 60 working days may be required in the event the RSO becomes unavailable to be consulted either in person or by other means concerning radiation safety matters . Reference is in accordance with VHA Permit Number 31-00636-07. In the event that this occurs, the Contractor shall become available to fulfill RSO coverage.

Section 2.16.1 has been changed at the request of the service line. Section 2.16.1 now reads: The contractor shall provide a checklist with worksheet originals indicating work to be performed and actual values obtained. Contractor must maintain an Inspection Record Log. Each service report shall include

Section 2.19.4 has been deleted and original Section 2.19.5. has been updated at the service lines request too now read: Upon completion, the Contractor shall be required to check-out with Biomedical Engineering

36C24222Q0821 0002

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Section 2.24.2 has been changed at the request of the service lime. Section 2.24.2 now reads:

VHA requires the inspection of CT scanners following repairs or modifications that may affect patient dose or image quality, further, a medical physicist must perform and document testing after these repairs for modifications. Testing should be performed as soon as possible but within 30 days. However, initial testing should be performed by the FSE and the inhouse QC technologist prior to clinical use. This testing is necessary to ensure that repaired or modified CT scanners do not expose patients to radiation doses that exceed national standards.

Section 2.26.2. has been changed at the request of the service line. Section 2.26.2 now reads:

Measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following CT protocols: adult brain, and adult abdomen. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.

Request of Clarifications and responses that Contracting has received responses to as of 07/26/2022 are listed below:

Clarifications for Bronx VAMC Solicitation 36C24222Q0821:

Will the VA require a version of the bids be submitted with all company and staff information redacted to ensure the source selection group is not unduly biased?

CO Response: Refer Section E 15.b. It is at the discretion of the Program Manager to hold a brief exchange with candidates. Questions may be asked that will reveal current employers.

Resumes will be evaluated to ensure the candidates meet the qualifications.

Will the VA ensure the bids are evaluated under the VA’s tiered evaluation criteria? If not, what is the VA’s justification for not using a tiered evaluation process?

CO Response: There is no source selection Evaluation group as this procurement is under FAR Part 13, Request for Quote and not a Request for Proposals. Refer to section E, bullet 13 for Basis of Award.

Is the Bronx VAMC Radiation Safety Officer (RSO) a physician, physicist, or technologist?

CO Response: Question sent to Bronx VAMC

Solicitation, B.2 Schedule – This section says the contractor shall provide three board certified physicists, but elsewhere in the solicitation in the Key Personnel attachment the VA asks for four certified physicists. How many physicists need to be included as Key Personnel?

CO Response: Schedule was updated under Amendment 001.

Key Personnel – Much PII is being asked for by VA. To protect staff members’ private information (such as residential address and cell phone number) will the VA remove this request? Also, state medical physics licenses should not be part of credentialing for a federal facility. Liability insurances are typically held by physicists’ employer, not at the individual level

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– it is atypical for VA physics contracts to ask for individual coverage certificates. Further, NCHC results are not traditionally communicated in bid materials, but rather, are logged electronically in eVerify and VA stakeholders can look up the results. Again, this protects the disclosure and privacy of personal data. We believe the VA should simply ask bidders to certify that the key personnel being bid meet the SOW requirements and that their PII information be provided following contract award.

CO Response: All contracted personal will be required to go through a National Criminal Background check. Contracting and all other VA staff who are involved with background checks will have access to each candidates PII. Post Award to the awardee will be required to provide additional PII.

Solicitation, B.2 Schedule CLIN 0001d – With the VA being a federal facility and therefore, not answerable to any state authority – including NYSDOH, can this item be removed or redefined?

CO Response: An Amendment was posted 07/11/2022 on Contract Opportunities.

Solicitation, B.2 Schedule CLINs 0001a, 0001b, 0001c – The units on these CLINs appear to conflict with the statement in B.1.3 where the VA is asking for monthly invoices. Will the VA update the schedule for these CLINs to reflect monthly unit & quantities?

CO Response: An Amendment was posted 07/11/2022 on Contract Opportunities

B.2 Schedule CLIN 0001e – This annual report is typically furnished by the RSO, are we to understand that offerors will be assuming RSO duties as part of this work?

CO Response: An Amendment was posted 07/11/2022 on Contract Opportunities

Is the Bronx VAMC Radiation Safety Officer (RSO) a physician, physicist, or technologist?

Station Response: Physician

B.3 PWS 1.1 – As a federal institution, none of the VA campuses are subject to regulation by State authorities. In particular, the State of New York & NYC impose additional requirements on radiology programs which are not in line with NHPP regulations and VHA Directives and would result in increased cost to the VA to uphold these rules. As an example, NYSDOH radiation regulations require quarterly testing of diagnostic x-ray units, whereas the VHA Directive 1129 (the governing document for x-ray machine QA) mandates testing of x-ray units only once every 14 months. The VA stands to save money and administrative burden by availing itself of adhering to State regulations. Will the VA remove references to New York State Department of Health and New York City Department of Health? The NYSDOH has absolutely no jurisdiction for medical physics work at the VAMC.

Station response: James J. Peters VAMC will maintain compliance with NHPP and local regulatory bodies. Maintaining compliance with local regulatory bodies will ensure JJP VAMC is meeting the same standards as all hospitals within NYC.

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B.3 PWS 2.1.4 – What is meant by a gap in education history? If a physicist meets the qualifications and is awarded a certificate through a nationally recognized body such as the American Board of Radiology, why would the VA be concerned regarding the physicists’ academic journey?

Station response: The physicists’ academic journey after certification is a concern for JJP VAMC because a physicist must complete continuing education to maintain his or her certification from the American Board of Radiology. Maintaining their license is a requirement for the duration of the contract.

B.3 PWS 2.6.1 – Can the VA clarify what the expectations/deliverables are in this statement?

CO Response: Refer to Section 2.10 Contractor Responsibilities

B.3 PWS 2.6.2 – This section appears redundant with 2.1.4 and introduces more stringent requirements. With the VA being a Federal Institution, items 2.6.2.1.1, 2.6.2.1.2, 2.6.2.1.4 would not be applicable. Will the VA remove these from the solicitation?

Station response: James J. Peters VAMC will maintain compliance with NHPP and New York State guidelines. Maintaining compliance with NY State guidelines will ensure JJP VAMC is meeting the same standards as all hospitals within NYC. Therefore, it will make JJP VAMC as competitive as the private sector and ensure the veterans are receiving high quality imaging services.

B.3 PWS 2.7.2 – Can the VA clarify what is the concern with having the contractor off-site for 3 consecutive days or more? Is the VA expecting the contractor to show up daily? Many diagnostic physics contracts within the VA are fulfilled on a very part-time basis.

CO Response: Tailor of 2.7.2. will be updated as this is standard verbiage for full time FTE and not geared toward the services requested within in the PWS. Section updated too: For temporary substitutions where the key person shall not be reporting to work when required for services, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person requested to perform services IAW the Schedule of Healthcare Resources.

B.3 PWS 2.9.1 – Can the VA clarify what is meant by a schedule for Diagnostic Medical Physicists being in accordance with the NRC? Typically, scheduling of physicists supporting a clinic is resolved between the physicist and the facility POC.

Station response: The physicist should provide a schedule for testing that is in accordance with NRC’s regulations for quality assurance and coordinate all visits with the POC.

B.3 PWS 2.9.2 – What documentation does this refer to? Normally, supporting physicists submit survey reports to their clients via email. For clarity, we recommend removing this item as it does not add clarity to offerors.

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Station Response: JJP VAMC accepts a verbal comment with the physicist concerning the inspection or testing during the time of visit and will also receive an electronic final report following the visit.

CO Response: Section 2.9.2. was removed. Section 2.16.1.1 added verbiage: . Reports shall be submitted upon completion either electronically and/or hardcopy.

B.3 PWS 2.9.4 – The nature of physics support is tied to deliverables such as survey reports, not ‘shift coverage’. Time and attendance sheets should not be applicable to this type of service. We recommend removing the Time and Attendance tracking from the contract.

CO Response: 2.9.4. will remain and not removed.

B.3 PWS 2.10.2 – The ambiguity in this statement as to whether contractors are to directly fill the role of RSO or not is unnerving. The job of RSO would require a much larger time commitment than 20 hours/year, as CLIN 0001g suggests. We recommend that the VA either commit to making a contract mod to accommodate the contractor becoming the RSO or create a new CLIN in the solicitation and allocate 8 hours /month minimum for contractors working as the RSO.

CO Response: Schedule of Healthcare Services have been changed from 20 estimated hours to 50 estimated hours to account for Annual RSO training. These are only an estimate and hours may be increased at the discretion of the government. As long as the maximum allowable does not exceed the stated threshold and funding is available hour may be increased. Station did not give an answer to both requests from Contracting.

B.3 PWS 2.10.3 - For a physicist supporting the RSO and fulfilling these duties, 20 hours a year (based on CLIN 0001g) is not nearly enough allocation to set up contractors for success. As an example, merely attending quarterly Radiation Safety Committee meetings, would use 25% of the time-budget for supporting the RSO. The PWS clearly indicates contractors will not be ‘spectators’ in the execution of the Radiation Safety Committee with language such as “…serves as the functional and operational arm of the facility RSO and Radiation Safety Committee…” and duties in 2.10.3.3. While we recognize this is an Indefinite Quantity contract, we suggest increasing the initial 20 hrs/year estimate to at least 60.

CO Response: RSO is only for back-up on an as needed basis if needed. The contract is an IDIQ contract, and the hours were estimated. Requested station to provide estimated number of hours annually. Estimated number of hours shall be increased to cover annual training as this shall fall under the RSO additional duties. Schedule has been updated under Amendment 0002 that reflect new estimated number of hours and Line-Item Description.

B.3 PWS 2.10.3.2 – These incidents are rare for most medical facilities, it is next to impossible to predict an appropriate level of effort, we recommend incorporating this incident response into CLIN 0001f and expanding 0001f’s definition to “Additional unscheduled program support, such

8 | P a g e as extra equipment surveys, patient dose calculations, disaster response, incident investigation / reporting, etc.”

CO Response: Schedule was updated under Amendment 001

B.3 PWS 2.10.3.4 – These duties and items are responsibilities of the RSO, per VHA Directives.

If contractor serves as support to the RSO, will they be performing these items, or will the VA RSO be doing these tasks?

Station response: The tasks are the responsibility of the RSO but will require periodic assistance by the physicist to complete.

B.3 PWS 2.10.3.6 – Does the Bronx VA have a system whereby; protocol information is readily accessible? Does the Bronx VA have a system to aggregate and collect patient radiation exposure data? We recommend that the VA create a separate CLIN for the analysis and reporting of patient Computed Tomography and fluoroscopy exposure data and protocol review. We also recommend the VA include in this CLIN attendance at quarterly dose optimization meetings, to be compliant with applicable Joint Commission requirements.

Station response: The dose reporting is manually completed by the technologist. JJP VAMC does not have a dose watch software.

B.3 PWS 2.10.3.8 – VHA Directives require x-ray equipment be inspected once every 14 months, why is the PWS asking for semi-annual x-ray evaluations? The VA would save money and increase patient access to care by adhering to its own corporate policy and removing the semi-annual x-ray testing frequency.

Station response: JJP VAMC will follow both the VHA and local regulatory guidelines.

Following more stringent guidelines ensure the veterans are receiving high quality imaging services and helps to ensure the x-ray cameras are properly functioning.

B.3 PWS 2.10.3.9 – We recommend taking this item and combining it with 2.10.3.6 into a new CLIN as described above.

CO Response: services for 2.10.3.6 and 2.10.3.9 shall fall under line Items 0001g’s these services fall under additional assistant to the RSO

B.3 PWS 2.10.3.10 – Who is the intended recipient of this instruction? How is it to be delivered, written reference materials, an in-person presentation, or TMS course? For most personnel in a VA hospital, radiation safety courses in TMS are sufficient to meet needs of compliance with applicable VHA, ACR, and TJC requirements.

Station response: All required training is conducted in TMS and is the responsibility of the department to ensure completeness. At our request, the physicist is periodically asked to provide onsite training.

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B.3 PWS 2.10.3.11 – We recommend the VA change this wording to include “all applicable testing to diagnostic medical physics required by The Joint Commission…” and keep contractors obligated to stay in their field of expertise.

CO Response: Section 2.10.3.11 changed too: The contracted Certified Diagnostic Medical Physicist (s) agrees to perform applicable testing required by The Joint Commission and reports will demonstrate The Joint Commission verbiage.

B.3 PWS 2.10.4 – How will contractors’ invoice for these services? There does not appear to be CLINs which support emergency preparedness / disaster management efforts. If it is unlikely that these services would be needed on a routine basis, we recommend that this be removed from the contract and negotiated separately in the future (if needed).

CO Response: If additional assistance is needed, the contractor shall bill under line Items 0001g’s, as these services fall under additional assistant to the RSO.

B.3 PWS 2.10.5 – This item might be better left off the contract and established in-person with the COR and RSO upon kickoff, as it does not directly affect proposals from offerors. It also sends a message to offerors that the physicist supporting the RSO will encounter “we’ve always done it this way” mindset. We recommend that the VA remove this item from the solicitation and establish personality expectations at kickoff with the winner.

Station response: JJP VAMC does not have the physicist create policies. However, the physicist does work with the RSO to revise and update policies as needed.

B.3 PWS 2.10.6 – This statement conflicts with the schedule where the contractor is not the RSO but will be supporting the RSO as an associate. If the intent of the VA is to have contractors be the RSO, then these conflicts must be resolved for offerors to produce accurate proposals.

Station response: As previously noted, the RSO has the ultimate responsibility but will sometime need the contractor for assist in some situations.

B.2 Contract Minimum and Maximum: With the contractor supplying an RSO (recommended at least 1-day each month), diagnostic equipment testing, emergency support services, disaster management, patient dose management and protocol optimization services, it should be expected that a 5-year contract encapsulating this scope would exceed $300,000.

CO Response: Min and Max may be revised based on the evaluation of offerors price quotes if pricing is deemed fair and reasonable.

B.3 PWS 2.10.7.5 – Will the VA be furnishing these reports and documents to the contractor for signature and review? Many of these reports are generated only annually, is this review session an annual expectation of the Bronx VA?

Station response: JJP VAMC will furnish reports and documents to the contractor for assistance as needed when due for revision and update. The contractor provides oversight.

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B.3 PWS 2.10.7.5.8 – What waste is the Bronx VA generating that is not from short-lived products? Is there a research component to their radioactive materials program?

Station Response: Bronx VA generates long-lived waste from 6 research labs. The radionuclides are as follows: H-3, P-32, C-14. I-125, S-35.

B.3 PWS 2.10.7.5.2 & 2.10.7.5.9 – Will the VA be tracking their own staff training? The VA is much better equipped to follow-up with their own staff than rely on an outside contractor to retrieve and handle communications among VA personnel regarding training dates and follow-

up. There are radiation safety training courses available on TMS that are best suited for this task.

Station response: This is a common item for contractors to provide/document training the to VA staff. We document internally all training for that individual but the company document the training they provide only. Cantel, Olympus, Getinge, BD Alaris, etc provide .

Station response: JJP VAMC is in concurrence that this is the facility’s responsibility and not the contractor. However, the contractor is expected to provide documentation of training when contractor provided the training.

Section 2.10.7.5.9. was deleted under Amendment 0001

B.3 PWS 2.10.7.6 – Is this report the same as described in 2.10.7.5.8? Does the VA furnish this report for contract physicist review, or does the contractor create this report for the VA? It is unclear.

Station Response: The contractor provides the annual radionuclide sewage calculation and clean air calculation for the EPA reports as well as the quarterly radiation safety QA report for nuclear medicine and research labs.

B.3 PWS 2.10.7.7 – Similar to above note on 2.10.5.2 and 2.10.7.5.9. The VA is much better positioned to track staff training internally than rely on contractors who are coming on-site infrequently throughout the year. We suggest removing this line item.

Station response: This is a common item for contractors to provide/document training the to VA staff. We document internally all training for that individual, but the company document the training they provide only. Cantel, Olympus, Getinge, BD Alaris, etc provide .

Station response: JJP VAMC is in concurrence that this is the facility’s responsibility and not the contractor. However, the contractor is expected to provide documentation of training when contractor provided the training.

Section 2.10.7.5.9. was deleted under Amendment 0001

B.3 PWS 2.10.7.8 – This item should be placed on the RSO, unless it is the intent of the VA to have the contractor be named the RSO. It is disingenuous to have so much RSO responsibility given to someone other than the facility RSO. Without correction, we feel that individuals (the

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RSO and the contractor) are being set up for failure in the execution of their duties – the lines of accountability between the two are blurred.

Station response: The contractor is expected to ensure corrective actions are done

B.3 PWS 2.10.8 – Is it the intent of the VA that contractors will be conducting Radiation Safety Training in-person with all interested VA departments (radiology, surgery, GI, NucMed, Biomed, Dental, Housekeeping, Police)? If so, where/how would these services be billed in the schedule?

CO Response: the contractor shall bill under line Items 0001g’s, as these services fall under additional assistant to the RSO.

Station Response: The training will be for all affected services as needed. The training must be carried out in person.

CO Response: Section 2.10.8 has been updated to read as: Radiation Safety Training for the Bronx VAMC Radiation Staff will be provided by the Certified Diagnostic Medical Physicists during the times from 8:00 am to 4:00 pm annually to go over radiation safety. Coordination’s shall be made with radiation safety supervisors and COR. All training shall be conducted onsite and in person by the Contractor. The training will be for all affected services as needed.

B.3 PWS 2.10.8.1 and 2.10.8.2 – How frequently is this training expected to be provided?

CO Response: Refer to section 2.10.8, states Annually

B.3 PWS 2.12.1 and 2.12.2 – These activities pose extra expense and burden to the VA.

Recommend removing the quarterly and semiannual frequency components as well as all references to NYSDOH, NYCDOH, Part 16 NY State Sanitary Code as their jurisdiction does not apply in any way shape or form to a federal institution, such as the VA. The NYCDOH has absolutely no jurisdiction for medical physics work at the VAMC.

Station response: JJP VAMC will follow both VHA and local regulatory guidelines. Following more stringent guidelines ensure the veterans are receiving high quality imaging services, which is a priority.

B.3 PWS 2.12.3.5 – For CT QA, the VA is better aligned to following ACR requirements and not a state. We recommend that the VA adopt the ACR model for QA on all advanced modality systems, including CT.

Station response: JJP VAMC follows the state guidelines which complies with the ACR guidelines but recommends an additional semi-annual visit.

B.3 PWS 2.12.4 – We recommend the VA remove the term ‘emergency’ from a CT x-ray tube replacement. Such language is appropriate for a Vendor/Field Service Engineer (FSE) contract but not a medical physics contract. In fact, there is a tremendous amount of language in the solicitation that looks to be cut and paste from a FSE contract that is not at all appropriate for a

12 | P a g e medical physics contract. For the medical physicist, CT x-ray tube replacement is a routine expectation over the life a CT x-ray system and simply requires a physicist to follow-up with confirmatory physics testing within 30 days of the FSE repairs.

Station response: JJP VAMC follows the requirement for CT tube replacement tested by the physicist within 30 days. The immediate testing should be performed by the FSE upon replacement

B.3 PWS 2.12.5.1 – Gauss line measurements are typically a static entity, meaning a facility has only to measure it once and it stays consistent for the life of the unit. We recommend the VA clarify if this is to be an annual contract requirement or just a one-time service?

Station response: Gauss lines should be measured upon equipment installation and upon request when changes in the system result in magnetic field changes.

B.3 PWS 2.12.6 – For CR readers, we recommend the VA removing these antiquated devices from their inventory or aligning physics testing criteria to AAPM Task Group Report 93, rather than the NYSDOH requirements. The NYSDOH has absolutely no jurisdiction for medical physics work at the VAMC.

Station Response: We expect this unit to be tested consistent with New York State requirements.

B.3 PWS 2.12.9 – We recommend incorporating this service into CLIN 0001f and calling the item “Additional unscheduled program support, such as extra equipment surveys, patient dose calculations, disaster response, incident investigation / reporting, in-service training/presentation, etc.”

CO Response: Schedule was updated under Amendment 0001 and Amendment 0002

B.3 PWS 2.13.2 – This item is unclear as nuclear medicine services were previously defined in the PWS as quarterly, yet this line says tests are to be done monthly. Also, the expectation of a physicist to report within 60 to 100 minutes in NYC’s Bronx with all its’ traffic prowess is unrealistic. Many nuclear medicine camera performance issues are resolvable over the phone or often require the collaboration between the physicist, nuclear medicine technologist, and field service engineer. It is unrealistic to expect all three parties’ workflow to be interruptible to within 60 minutes. We believe the 60 to 100 minutes response text was drawn from a Vendor/Field Service Engineer (FSE) contract. Further, there is no VHA Directive or ACR or TJC requirement that supports these response criteria. This statement is off-putting to offerors and will limit the VA’s pool of talented candidates to perform the work. It also unnecessarily and unfairly restricts the eligibility of bidders to an incredibly limited supply. Limiting the procurement with unnecessary restrictions presents an unfair and noncompetitive process. We recommend the VA remove this requirement from the contract and instead establish logistical/personality considerations at contract kick-off.

Station response: If the issue cannot be resolved on the phone and a site visit is needed, JJP VAMC expects the contractor to be onsite within 2 hours.

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B.3 PWS 2.14 – We recommend incorporating these unscheduled visits into CLIN 0001f and call it “Additional unscheduled program support, such as extra equipment surveys, patient dose calculations, disaster response, incident investigation / reporting, etc.”

CO Response: Schedule was updated under Amendment 001

B.3 PWS 2.15 – Recommend removing statements on quarterly and semi-annually and conduct all required testing once every 12 to 14 months, per VHA directives. This would save the VA money and create fewer site visits/schedule interruptions without any loss of quality.

Conducting VHA directed mandatory annual tests on a quarterly basis is nothing more than a fleecing of the VA by local contractors padding their revenues.

Station response: JJP VAMC prefers to follow the stricter requirements of New York State.

B.3 PWS 2.16.1 – Physicists typically do not maintain operation and service manuals for equipment, those are usually on-file with biomed or the vendor’s field service engineering service. We recommend deleting the entire second sentence in this paragraph as it does not apply to a physicist work scope.

Station Response: Second Sentence will be deleted.

CO Response: Section 2.16.1 has been changed at the request of the service line. Section 2.16.1 now reads: The contractor shall provide a checklist with worksheet originals indicating work to be performed and actual values obtained. Contractor must maintain an Inspection Record Log. Each service report shall include

B.3 PWS 2.17.1.3 – The evaluation of diagnostic imaging equipment for purchase is a long, intensive, and largely bureaucratic process. Support for this service should warrant its own CLIN, if pursued at all. Procurement of radiology equipment is traditionally performed in-house with facility staff. Many contract offerors would shy away from getting involved in this effort to avoid any potential conflicts.

Station response: JJP VAMC expects the physics contractor to assist when requested in selection of new equipment and technologies.

B.3 PWS 2.17.1.4 – Quality control manuals should be furnished by OEM or vendors. This is not a diagnostic physicist duty.

Station response: JJP VAMC expects the physics contractor to supply QA/QC manuals

B.3 PWS 2.17.1.6 – This duty is better delegated to the RSO.

Station response: Although it is the responsibility of the RSO, JJP VAMC will consult with the physics contractor as needed and require them to update our facility when there are changes in regulations

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B.3 PWS 2.19.3 & 2.19.5 – Turn around for reports is typically within 30 days, with the caveat that if anything is amiss in terms of equipment or an audit then that observation is communicated to the client prior to the physicist leaving the facility. We recommend the VA accommodate a longer window for physics reports (to allow for a report QA peer review) and ask physicists to close out site visits with the COR prior to departure for the day.

Station response: JJP VAMC finds 7 business days as a reasonable request for the report turn around. It’s understood equipment may be tested before or after business hours to not impact the clinical schedule. When this occurs, JJP VAMC expects a notification, either verbal or electronic with a summary of the finding.

B.3 PWS 2.19.4 – Recommend removing this item and the term ‘FSE’ from 2.19.5. This is a contract for physicists, not field service engineers. In fact, there is a tremendous amount of language in the solicitation that looks to be cut and paste from a FSE contract that is not at all appropriate for a medical physics contract.

Station Response: Section 2.19.4 will be deleted and the term FSE from original section 2.19.5 will be removed and replaced with Contractor.

CO Response: At the service lines request, section 2.19.4 has been deleted and original Section

2.19.5. has been updated to now read: Upon completion, the Contractor shall be required to check-out with Biomedical Engineering

B.3 PWS 2.21.3 – Can the VA explain how this is different from a tube replacement/repair? If an x-ray or fluoroscopic or CT unit has a blown tube, it too becomes inoperable. However, once a repair is effectuated and the machine passes relevant OEM/biomed checks it is then promptly put back into clinical use. Why would another component be viewed differently? Perhaps the VA would better clarify this posture would only apply for mammography units.

Station response: Not all repairs need to be tested by the physicist prior to use, unless required by the FDA MQSA (mammo) guidelines.

B.3 PWS 2.24.2 – This statement is incorrect in that VHA requires follow-up testing by medical physicists within 30 days of repair or modification that affects image quality or patient dose. Will the VA amend this statement to align with VA Directives?

Station response: JJP VAMC agrees the medical physics testing should be performed within 30 days. However, initial testing should be performed by the FSE and the inhouse QC technologist prior to use.

CO Response: Section 2.24.2 has been changed to: VHA requires the inspection of CT scanners following repairs or modifications that may affect patient dose or image quality, further, a medical physicist must perform and document testing after these repairs for modifications. Testing should be performed as soon as possible but within 30 days. However, initial testing should be performed by the FSE and the inhouse QC technologist prior to clinical use. This testing is necessary to ensure that repaired or modified CT scanners do not expose patients to radiation doses that exceed national standards.

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B.3 PWS 2.25 – This test is not required by any federal regulation or accreditation criteria, and stems from the VA subjugating itself to NYSDOH rules. Will the VA remove this requirement?

The NYSDOH has absolutely no jurisdiction for medical physics work at the VAMC.

Station response: JJP VAMC wants to follow the NYS requirements

B.3 PWS 2.26.2 – The Joint Commission (TJC) does not require radiation dose measurement for pediatric protocols if that facility is not accredited for those modules or if that facility does not perform pediatric studies. TJC does however, require dose measurements of 4 different protocols annually. We recommend that the VA remove the pediatric protocol testing requirement from the contract since it is not applicable to their program and instead, require contractors to perform radiation dose measurements for 4 different protocols annually.

Station response: Service line agreed to the remove the pediatric protocol testing requirement from the contract since it is not applicable to the program and will require contractors to perform radiation dose measurements for 4 different protocols annually.

CO Response: As requested by the service line; Section 2.26.2. has been updated too:

Measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following CT protocols:

adult brain, and adult abdomen. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.

As accreditation requirements change over time, we recommend that the VA incorporate language into their PWS that accommodates these updates. For example, slice thickness accuracy is no longer a requirement for testing CT scanners as of ACR’s 2018 update to CT testing QA.

Station response: JJP VAMC agrees the testing should be performed according to current requirements. Please note that slice thickness measurement is a New York State requirement, and it is expected for this test to be performed by the physicist.

ATTACHMENTS INCLUDE:

1. See attached document: Revised Schedule of HCR Services.

2. See attached document: PWS 07262022.