Questions and Answers Amendment.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. NUMBER3. 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 9

0001 02-08-2021

Department of Veterans Affairs

Network Contracting Office 6

100 Emancipation Drive

Hampton VA 23667

Department of Veterans Affairs

Network Contracting Office 6

100 Emancipation Drive

Hampton VA 23667

To all Offerors/Bidders 36C24621Q0261

01-26-2021 X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to:

See CONTINUATION Page

X 1

1. The purpose of this Amendment is to provide answers to vendor provided questions.

a. See pages 2-3 for questions and answers.

b. See pages 4-8 for amended solicitation pages.

2. All other terms and conditions remain unchanged.

Mario L. Santiago

Contracting Officer

Questions & Answers

Question # 1 Page 4 (B.2 Price Schedule) Can you confirm that services listed on the price schedule including abbreviations “SB” indicate a request for Stand-by Laser service Rates?

Answer #1: Yes

Question # 2 Page 4 (B.2 Price Schedule) A variety of disposable fibers (different types and sizes) are used in conjunction with the requested lasers. The price schedule requests pricing for the Aura Accustat Fiber used with the Aura KTP laser only. Can you please confirm that the VA has all the fibers needed for use with the Holmium, Greenlight XPS, OmniGuide Laser, and KTP laser?

Also, what Ultrasound probes are being used by the VA physicians? Can the VA provide the manufacturer probe description(s) and product number(s)? Can we assume the Vendor is required to provide the probe and the use of the probe should be included in the Ultrasound service rental fee?

Answer #2: No, the VA will not provide supplies

B.3 PWS 3-C PAGE 8-9 “Contractor will also provide the necessary attachments, supplies, and fibers needed to operate each laser, including a backup to ensure continuity of service.”

On Ultrasound Rental fee, the machine and probe should be provided by the contractor.

Ultrasound Model# Flex Focus 800, Probe Model# 8826

Question # 3 Pages 4 & 10 (B.2 Performance Work Statement; B.3 Performance Work

Statement) Central Virginia VA Healthcare System (CVHCS) 1200 Broad Rock Boulevard, Richmond, Virginia 23249 is referenced on Page 4. CVHCS is referenced throughout the solicitation. The Place of Performance stated on Page 10 is 1201 Broad Rock Blvd, Richmond

Virginia 23249. Can you confirm that the place of performance is Richmond VA Medical Center

(VAMC) located at 1201 Broad Rock Blvd, Richmond Virginia 23249?

Answer #3: The Richmond VA Medical Center Changed its name from Hunter Holmes

McGuire Veteran Affairs Medical Center to the Central Virginia Healthcare System (CVHCS).

The address on page four is a typo and should read 1201 Broad Rock Blvd, Richmond Virginia

23249.

Question # 4 Page 8 (B.3 Performance Work Statement) Emergency response time is 30 minutes. Given the technician would need to be dispatched and then complete check-in procedures in the facility, is a 30-minute response time realistic? For add-on emergency cases, is the VA amenable to working with the Vendor to agree mutually on a scheduled start time for the emergency add-on surgical case on a case-by-case basis?

Answer #4: Yes, 30 mins. is realistic, timeframe is from notification of need to arrival.

No, the facility should maintain control of the timeframes, especially on an emergent case.

Question # 5 Page 9 (B.3 Performance Work Statement) To better understand your facility’s particular needs, can you provide some details around the contract condition that all lasers remain in permanent storage at the facility? Is the Richmond VAMC amenable to engaging in a discussion regarding this requirement?

Questions & Answers

The VA’s original response indicated a case volume of: “Holmium: (completed: 111, stand by

65); Ultrasound: (completed: 41); Cryo: 1; CO2: 1; Other: (completed: 32, stand by: 1)”

Since the largest number of case requests are those for the Holmium laser system, would the VA be amenable to having just the Holmium laser stored at the facility? In addition, one market constraint that may make it impossible for any vendor to comply with this requirement is a decision by the manufacturer to discontinue production of the Aura KTP laser system. As a result of this manufacturer decision, there are a limited number of laser systems available to meet the demands of the physicians who still prefer this technology. Dedicating an Aura KTP laser system to the VA site will limit our ability to serve other patients.

Answer #5:

No, the equipment needs to be staged in the facility due to the rigorous process of inspection and approval. if so, happen the equipment will be out of the facility, it needs to be re-inspected by

Biomed. Which will cause a delay in an emergent case, especially after hours.

The end users are fully aware of the discontinuation of Aura KTP Laser. For now, they are in the process of testing various alternatives.

Question # 6 Page 9 (B.3 Performance Work Statement) What treatments is the CO2 Ultra-

Pulse laser system being used for and are there specific accessories required to complete the prescribed treatment?

What treatments is the KTP laser system being used for? Are they different from the treatments where the Aura KTP is being used?

Answer #6: Co2 will be used in Plastics Service and Aura for Ear Nose & Throat (ENT) Service

Question # 7 (B.3 Performance Work Statement; B.4 Special Contract Requirements; D.1

QASP) Our credentialing department ensures, on an ongoing basis, that all technicians maintain valid licensure, if applicable, and complete all the specified training necessary to provide service in its contracted facilities. Industry-standard requires only trained technicians and there are no licenses/certifications required in the State of Virginia for laser operators. Are you amenable to removing the language relating to Technician Licensing?

Answer #7: Yes, we can amend the language as applicable.

Amended pages 8-11, 14 and 50. Please see the attached pages and replace current pages.

Question # 8 Is an incumbent contractor currently performing these services, or if this is a new requirement. If this is a follow-on requirement, could you please provide the previous contract or task order number?

Answer #8: Yes, the current contract is held by Fortec, Medical Inc.

Current Contract Number: 36C24621P0021

36C24621Q0261

B.3 PERFORMANCE WORK STATEMENT

1. Background

A. The purpose of this contract is to provide the Central Virginia Healthcare System (CVHCS) with continuous rentals of mobile laser machines assisted by trained and credentialed technicians to operate the equipment listed in the schedule of services, all ancillary equipment and fibers as requested by the surgeons/staff to complete necessary surgeries. The lasers will be used for urology, ears, nose and throat (ENT) and general surgery in the operating room.

An average of 180 laser surgeries annually is anticipated. Cost basis will be based on contractor being reimbursed for actual supplies/services delivered.

Laser surgeries are less intrusive, cause the least amount of risk to the patient and allow for a reduced recovery time for the veteran. Routine procedures will be scheduled during normal business hours. Monday through Friday 8:00 a.m. to 4:30 p.m. Contractor must be able to provide technicians and equipment to operate 4 operating rooms concurrently, when needed and as ordered by the Contracting Officer Representative (COR). Non-routine, emergency services will be required as needed. The technician must be able to arrive at the hospital within

30 minutes of being contacted for emergency surgeries.

2. Objectives

A. With respect to each laser, an overview of this PWS will include the following goals and objectives the CVHCS has a need to continuously rent mobile laser equipment for various surgical procedures. If a laser is inoperable for 60 minutes or more with the result that the designated surgeon must postpone surgical procedures the contractor will forego the charge for that surgical procedure.

3. Scope, Tasks, or Requirements

A. The general scope of the work the contractor will be performing is to supply the

Government (CVHCS) with mobile laser equipment to be stored at the facility and a certified and credentialed technician to operate the lasers on specific scheduled days designated by the CVHCS. The certified technician will bring the requested laser directly to the operating room at CVHCS for use in operative procedures. It is expected that all requested lasers meet the inspection criteria of the CVHCS BioMed Department.

B. Technicians shall maintain all applicable qualifications:

• Technician shall have certifications from the manufacturer of the equipment.

• Technicians shall have a minimum of 2 years of experience on the equipment.

• Technician must have completed the Laser Institute of America Medical Laser

Safety Officer Training course and the US Medical Education Foundation’s Laser

Nurse Specialist Training course or equivalent.

C. The types of lasers and service required by this VA facility include: the Argon Beam

Coagulator, Argon Beam Coagulator Stand By, CO2 laser, CO2 laser Stand By, Holmium

Laser Low Wattage, Holmium Laser Low Wattage Stand By, Aura XP Laser, Aura XP

Laser Stand By, Aura Accustat Fiber, KTP Laser, KTP Laser Stand by, OmniGuide Laser, OmniGuide Laser Stand By, UltraPulse CO2 Laser, UltraPulse CO2 Laser Stand By, XPS

Laser, XPS Laser Stand By, Ultrasound, Ultrasound Stand By. Contractor will also provide the necessary attachments, supplies, and fibers needed to operate each laser, including a backup to ensure continuity of service.

D. The lasers must be mobile, and able to accommodate Urologic procedures including, but not limited to, treatment of benign prosthetic hypertrophy (BPH), kidney stones, lithotripsy, excision of lesions, urological resection, irradiation of tumors in the bladder, and treatment of urethral strictures. They must also be able to accommodate ENT procedures including, but not limited to, endoscopic excision of oropharyngeal, hypopharyngeal, supraglottic, glottic, and subglottic resection of mucosal lesions, and facial skin resurfacing.

E. The CO2 laser must have the following specifications: working spot size of 350 microns;

sterile fibers; fiber must be able to be used without a handpiece (i.e. can be threaded through flexible bronchoscopes or endoscopes); consistent power output throughout the length of case (can be as long as 3-4 hours); handpieces that have working lengths of 6 cm, 13 cm, 18 cm and 24 cm; handpieces that are straight and bent at the tip of each of the above working lengths; ability to vary the power level and spot size control to allow for superficial peeling, fine cutting, ablation and coagulation, and cutting.

4. Selection Criteria

A. The objective standard of acceptable performance that is to be provided by the contractor is to have a certified and/or trained technician on the premises, readily available, on the day when the procedure(s) is/are being performed. The contractor should also acknowledge that the laser is in good working condition and is regularly maintained. The contractor will be liable for damages should patient injury result due to laser malfunction. The contractor must also indicate that enough insurance coverage is maintained for its employees and for its equipment.

5. Delivery Schedule

A. The contractor shall store all laser(s) at the CVHCS. The CVHCS shall afford the contractor not less than 24 hours telephone notice of the time of the first procedure. The contractor may remove the laser at the conclusion of the last scheduled surgical procedure and place it back to the storage area. Both the CVHCS and the contractor may, in the event of an emergency, cancel a scheduled day by 24 hours advanced telephone notice to the other. As an alternative, the party giving notice may request that the CVHCS and the contractor adopt an alternative time or site. Because of the contractor’s itinerary and because of CVHCS patient commitments, the rights to cancel and to request change may be exercised sparingly.

B. Usage – The CVHCS shall utilize the contractor’s laser for all surgical procedures for which such laser is designed.

6. Government-Furnished Equipment and Government-Furnished Information

A. The CVHCS certifies that each surgeon designated by the VA to operate the laser is trained and competent in the use of that laser in his or her surgical capacity. The CVHCS maintains a facility adequate and suitable for the operation of the laser. CVHCS shall perform or cause to be performed all medical services, supervision, diagnosis and patient care in accordance with all applicable professional standards. Further, each designated surgeon shall protect the laser from injury (including attempted modification) and shall be liable to the contractor for damages occasioned by improper use or handling, carelessness or neglect of the equipment.

B. The contractor will have a certified and trained technician on the premises, readily available, on the day when the procedure(s) is/are being performed. Only CVHCS’s employees, while in the performance of their official duties, and not the contractor’s employees, are covered by the Federal Tort Claims Act, 28 U.S.C. §1346(b), 2671 through

2680. The contractor acknowledges that the laser is in good working condition and is regularly maintained. The contractor will be liable and indemnify the CVHCS for damages should patient injury result due to laser malfunction. The contracted vendor acknowledges that it maintains enough insurance coverage.

7. Place of Performance

A. This work will be performed at a Government site and the address is 1201 Broad Rock

Blvd, Richmond Virginia 23249 (specifically in the CVHCS operating rooms) and not at the contractor’s site.

8. Period of Performance

A. The performance period will be April 1, 2021 to March 31, 2022 plus 4 option years.

9. Contractor’s Responsibility

A. The contractor shall perform services under the direction of the Central Virginia VA

Healthcare System Chief of Staff, Chief, Surgical Care Service Line, Section Chief

Urology Service Line. Section Chief Ear, Nose, and Throat (ENT) Service Line. Section

Chief Plastics Service Line and Section Chief General Surgical Services Line.

B. Contractor will hold and submit certificates of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Under no circumstances are Contractor’s employees considered CVHCS employees.

C. Technician(s) must be a trained to provide laser operator services and have laser safety training and certificate.

• Technicians shall maintain required training, registration and certification; records shall be provided to keep records current. Technicians shall maintain required training, registration and certification throughout the life of the contract.

D. Contractor shall complete all required training per CVHCS policies.

• Technicians shall meet all VA educational requirements and mandatory course requirements defined in the contract and additional as directed by the CVHCS.

E. 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.

• All (100%) Contractor’s physician(s) comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA.

F. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs, and upgrades to the equipment as required keeping it in optimal condition.

G. Technician(s) are subject to the same quality assurance standards as established by the Joint

Commission (JC).

H. The Contractor will provide services in accordance with ethical, professional and technical standards of the health care industry.

I. All (100%) of patient safety incidents are reported using Patient Safety Report within 24 hours of incident. Patient safety incidents shall be reported to Circulating Nurse and should be documented using Patient Safety Report Process (JSPR). All incidents reported immediately (within 24 hours).

J. Contractor shall ensure that the equipment is operational and includes all required ancillary supplies and attachments. All required laser surgeries are supported with a primary and backup machine.

K. Technician arrives on time to perform the required services

• Technicians shall arrive at a minimum of 30 or arrive with enough time for setup.

• Technicians shall arrive at the hospital within 30 minutes during weekend/emergency/afterhours notifications.

L. Technician shall provide all aftercare as required.

• All required aftercare for the equipment utilized during their procedures.

M. Technician shall have a positive performance record with the contractor & maintain a good rapport with the end user.

• Contractor shall maintain a record of positive performance of the technician and provide upon request.

• Any negative feedback from the end users will be addressed ASAP with the involved Section Chief, COR and the Contractor Representatives.

b. The COR will be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority.

3. QUALIFICATIONS:

Personnel assigned by the Contractor to perform the services covered by this contract shall have certifications from the manufacturer of the equipment and shall present a record of credentials and competencies for approval, to be kept on file in the Operating Room. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA

Facility Director.

4. WORK HOURS: As needed as scheduled by the COR

The services covered by this contract shall be furnished by the contractor as defined herein.

Contractor shall provide services Monday through Friday 8:00 a.m. to 4:30 p.m. for routine procedures as scheduled. Emergency procedures could be required outside of normal business hours and include arriving at facility 30 minutes from time of notification of emergency procedures. Scheduling of non-emergency services within 24 hours and must have the equipment and technicians available to complete four (4) or more procedures simultaneously.

National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day

Martin Luther King’s Birthday

President’s Day

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving

Christmas

And any other day specifically declared by the President of the United States to be a National holiday.

5. PERSONNEL POLICY:

The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel:

- general liability

- workers compensation

- professional liability insurance

- health examinations

- income tax withholding, and

- social security payments.

The table below is a sample that can be tailored – note that the table must identify where in the

PWS the standards are found for monitoring performance. Check the MSO Customer Resource

Center for approved mandatory QASPs.

6. PERFORMANCE MEASURES

Measures PWS

Ref#

Performance

Requirement

Standard Acceptable

Quality

Level

Surveillan ce

Method

Met AQL/DIDNOT MEET

AQL-CPAR Rating/Add

Comments

1- Technician

Qualifications

3.B Technicians shall maintain all applicable qualifications

Technician shall have certifications from the manufacturer of the equipment, Technicians shall have a minimum of 2 years of experience on the equipment, Technician must have completed the Laser

Institute of

America

Medical Laser

Safety Officer

Training course and the US

Medical

Education

Foundation’s

Laser Nurse

Specialist

Training course or equivalent.

100%

Direct

Observatio n – COR will review and have qualificatio n records on file.

Meet AQL:

Positive contractor performance evaluation.

Did Not Meet AQL:

1ST Offense = written notice to the contractor to correct the deficiency.

Subsequent offenses = other than positive contractor evaluation

2 - Maintains training, registration and certification

9.C Technicians shall maintain required training, registration and certification;

records shall be provided to keep records current.

Technicians shall maintain required training, registration and certification throughout the life of the contract

100% Periodic and

Random sampling

Meet AQL:

Positive contractor performance contractor to correct the deficiency.

Subsequent offenses = other than positive contractor evaluation

3 – Mandatory

Training

9.D Contractor shall complete all required training per VAMC policies

Technicians shall meet all

VA educational requirements and mandatory course requirements defined in the contract and additional as

100% Direct

Observatio n -

Contractor shall provide evidence of annual training

Meet AQL:

Positive contractor performance contractor to correct the deficiency.

Subsequent offenses = other than positive contractor evaluation