36C24418R0643-001.docx

36C24418R0643

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

503-18-4-927-0092 36C24418R0643 07-11-2018 Mark Knorr

(570) 824-3521 x 7222 08-1-2018

4:30PM EST

00244 Department of Veterans Affairs Network Contracting Office 4

X 621111 $11 Million X N/A X 00503 Department of Veterans Affairs James E. Van Zandt VAMC 2907 Pleasant Valley Blvd.

Altoona PA 16602 00244 Department of Veterans Affairs Network Contracting Office 4

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Mobile Cataract Surgery Support in accordance with performance work statement. Please see price/cost schedule starting on page 7.

See CONTINUATION Page X X X Shawn Smith Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Mark Knorr, Administering Contract Specialist, Mark.Knorr@va.gov Shawn Smith, Contracting Officer, Shawn.Smith@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 SPECIAL CONTRACT REQUIREMENTS

Under the authority of Public Law 104-262 and 38 USC 8153, the contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs Medical Center, Altoona, PA the services and prices specified in the Section entitled Schedule of Supplies/Services of this contract.

1. SERVICES:

a. The services specified in the Sections entitled Schedule of Supplies/Services and Special Contract Requirements may be changed by written modification to this contract.

b. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the VA at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

c. The services to be performed by the contractor will be performed in accordance with VA policies and procedures and the regulations of the medical staff by laws of the VA facility.

2. TERM OF CONTRACT:

This contract will be written as a 5 year Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The contract is subject to the availability of funds. The contractor shall perform no services after September 30th of any year until the Contracting Officer authorizes such services in writing.

3. QUALIFICATIONS:

Personnel assigned by the Contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the Altoona, PA VA Facility Director.

4. WORK HOURS:

a. The services covered by this contract shall be furnished by the contractor as defined herein. The contractor will not be required, except in case of emergency, to furnish such services during off-duty hours as described below.

b. The following terms have the following meanings:

(1) Work hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

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

New Year’s Day Martin Luther King’s Birthday Presidents 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.

(3) Off-Duty hours (if applicable): Friday through Monday, 4:30 p.m. - 8:00 a.m.

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

6. RECORD KEEPING:

The VA Medical Center, Altoona, PA shall establish and maintain a record keeping system that will record the hours worked by the contractor employee(s). Contractor's employee(s) shall report to the Administrative Officer, and/or Contracting Officer Representative (COR) at the Altoona, PA VAMC, or designee upon arrival at the medical center.

7. CONTRACT PERFORMANCE MONITORING:

Monitoring of contractors time shall be demonstrated through sign-in/ sign-out sheets. The contractor shall be required to sign an attendance log upon reporting to work and departing from work. 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 Contracting Officer.

8. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS:

The Contractor shall assign to this contract the following key personnel:

a. During the first ninety (90) days of performance, the Contractor shall make no substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information required by paragraph (c) below. After the initial 90-day period of the contract, the Contractor shall submit the information required by paragraph (c) to the Contracting Officer at least 15 days prior to making any permanent substitutions.

b. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The Contracting Officer will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

c. For temporary substitutions where the key person will not be reporting to work for three (3) consecutive work days or more, the Contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor compliance with the subcontracting commitments.

B.3 PRICE/COST SCHEDULE

The Contractor shall furnish all personnel to provide services necessary to perform onsite Mobile Cataract Surgery Support Services to eligible beneficiaries of the Department of Veterans Affairs Medical Center, Altoona, PA (hereinafter referred to as VAMC). The contractor’s provider(s)’ care shall cover the range of Cataract 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 national standards such as The National Board of Surgical Technology and Surgical Assisting or through the National Center for Competency Testing.

The Contractor shall propose the adequate number of personnel to be credentialed and be available for scheduling to meet the requirements of the contract.

Note: The Government shall order the below specified minimum contract value of services and may order up to and including the below specified maximum contract value of services through task orders under this basic IDIQ contract throughout the duration of the contract to include all ordering periods (if applicable). The maximum amount under this contract is not guaranteed.

IDIQ contract Minimum $ 95,000.00

IDIQ contract Maximum $1,500,000.00

Contract Period: 9/1/18 – 8/31/23 (Estimated) Ordering Period 1: 9/1/18 – 8/31/19

Annual Price

KEY PERSONNEL

NAME:____________

TITLE:____________

NAME:____________

TITLE:____________

Total for Ordering Period 1

Ordering Period 2: 9/1/19 – 8/31/20

NAME:____________

TITLE:____________

Total for Ordering Period 2

Ordering Period 3: 9/1/20 – 8/31/21

NAME:____________

TITLE:____________

Total for Ordering Period 3

Ordering Period 4: 9/1/21 – 8/31/22

NAME:____________

TITLE:____________

Total for Ordering Period 4

Ordering Period 5: 9/1/22 – 8/31/23

NAME:____________

TITLE:____________

Total for Ordering Period 5

Grand Total for Contract: $_________________________

B.4 Performance Work Statement for Cataract Surgery Support

1. GENERAL:

1.1. Services Provided: The Department of Veterans Affairs in Altoona, Pennsylvania requires a Contractor for cataract surgery support to provide the equipment, disposables, supplies, and technical support personnel needed to perform these services. Services will typically be scheduled for three days each month with the possibility of increasing services up to four days per month over the contract term at the Altoona VAMC.

1.2. General Scope: The general scope of the work the contractor will be performing is to supply the government (Altoona VAMC) with rentals of mobile cataract equipment and a trained surgical technician/coordinator to operate the cataract equipment and assist with room turnover (as needed) on specific scheduled days designated by the VA. The trained surgical technician/coordinator will bring the requested cataract equipment directly to the procedure clinic at the Altoona VAMC for use in operative procedures. It is expected that all requested cataract equipment meet the inspection criteria of the Altoona VAMC’s Biomedical Department and manufacturer’s guidelines for PM checks. In addition to monitoring cataract equipment before and during procedures, the surgical technician/coordinator shall serve as a consultant for all associated supplies and accessories.

1.2.1. Approximately seven cataract surgical procedures are anticipated to be scheduled per day, estimated three days per month with the possibility of increasing services up to four days per month during the term of the contract.

1.3. Place of Performance – 2907 Pleasant Valley Blvd. Altoona, PA 16602

1.4. Period of Performance- Contract is requested for a 5 year IDIQ

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. Experience- The Contractor shall have at least 1 year experience in providing these services to either the Federal Government or Civilian Agency.

2.1.2. Certification – The Contractor’s personnel assigned by the Contractor to perform the services covered by this contract shall hold certification through an accredited organization, such as The National Board of Surgical Technology and Surgical Assisting or through the National Center for Competency Testing. The Contractor’s personnel shall have at least 1 year previous experience in providing surgical tech services. Certification must be provided to the COR prior to commencing work under this contract and as renewed, if applicable.

2.1.3. Technical Proficiency - The Contractor’s Surgical Technician/Coordinator 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 award and thereafter at the request of the CO/COR to verify current and ongoing competency, skills, and training 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.

2.1.4. BLS: Contractor’s personnel shall be certified in American Heart Association Basic Life Support (BLS) prior to commencing work under this contract. BLS certification must be kept up to date and copies provided to the COR upon contract award and as renewed thereafter.

2.1.5. Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel that will be providing services on-site within five (5) calendar days after contract award to the COR. Tests shall be current within the past year.

2.1.5.1. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative Tuberculosis Skin Test (TST) or interferon-gamma release assays (IGRA) for all Contractors’ personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive TST or IGRA results. The TST or IGRA testing shall be repeated annually.

2.1.5.2. MEASLES, MUMPS, & RUBELLA TESTING: Contractors shall provide proof of immunity for all Contractor personnel.

2.1.5.3. VARICELLA: Contractors shall provide proof of immunity for all Contractor personnel.

2.1.5.4. ACELLULAR PERTUSSIS: Contractors shall provide proof of 1 dose of Tdap vaccination for all Contractor personnel.

2.1.5.5. INFLUENZA: Contractors shall provide proof that all Contractor personnel have received the annual Influenza vaccine unless it is contraindicated. If the Contractor personnel has a medical contraindication to the vaccine they shall be required to wear a mask during the Influenza season per VAMC’s Policy.

2.1.5.6. OSHA REGULATION CONCERNING OCCUPATIONAL EXPOSURE TO BLOODBORNE PATHOGENS: Contractor shall provide their own Hepatitis B vaccination series and hepatitis B surface antigen test results following the hepatitis B vaccination series; maintain an exposure determination and control plan; maintain required records; and ensure that proper follow-up evaluation is provided following an exposure incident.

2.1.5.7. 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.

2.1.6. Conflict of Interest: The Contractor and all contractors’ personnel 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.

2.1.7. Citizenship related Requirements:

2.1.7.1. The Contractor certifies that the Contractor 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 Department of Veterans Affairs patient referrals;

2.1.7.2. While performing services for the Department of Veterans Affairs, 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.

2.1.7.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs 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 Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.7.4. 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.

2.1.7.5. 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.

2.1.8. 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.

2.1.8.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contractor’s personnel(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.

2.1.8.2. 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.

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

2.3. 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.

2.4. Prohibition against Self-Referral: Contractor’s personnel are prohibited from referring VA patients to contractor’s or other practice(s).

2.5. Inherent Government Functions: Contractor and Contractor’s personnel 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.

2.6. No Employee status: The Contractor shall be responsible for protecting Contractor’s personnel 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:

2.6.1. Workers’ compensation

2.6.2. Professional liability insurance

2.6.3. Income tax withholding, and

2.6.4. Social security payments.

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

2.8. Key Personnel:

2.8.1. The Contractor shall provide one trained surgical technician/coordinator to provide and operate the cataract equipment and serve as the primary Scrub Technician for all procedures on the specific scheduled days designated by the VA.

2.8.1.1. 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. Should the VA Chief of Staff or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s personnel, she/he may request, without cause, immediate replacement of said Contractor’s personnel .The CO and COR shall deal with issues raised concerning Contractor’s personnel conduct. The final arbiter on questions of acceptability is the CO.

2.8.1.2. Contingency Plan: Because continuity of care is an essential part of the Altoona VAMC’s medical services, the Contractor shall have a contingency plan in place to be utilized in the event Contractor’s personnel, equipment, or supplies are unavailable for scheduled surgical procedure dates in accordance with the terms and conditions of the resulting contract.

3. VA HOURS OF OPERATION:

3.1. VA Business Hours are 8:00 a.m. – 4:30 p.m., Monday – Friday, excluding 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

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared to be a national holiday.

4. CONTRACTOR RESPONSIBILITIES

4.1. Equipment, Instruments, and Disposables: The types of cataract equipment required by the Altoona VAMC will be determined by the VA’s Physician to include all necessary disposables and IOL lenses as outlined below:

TABLE 1

Cataract Service Equipment, Instruments, & Disposables

Phaco-Alcon Centurion ( back-up machine)

Zeiss Lumera I Microscope Unit Per Visit (1)

Stryker Surgistool (1)

Equipment, Instruments, & Disposables

Instrument Set Per Visit (8)

Instrument Tray

Infinity Hand piece

Hard scope knobs

Universal scope knobs

Lieberman speculum

Thornton Ring

Drysdale

I/A Tip (8065-817801)

Lens Loading Forceps

Monarch iii

Straight Sinkey Hook

MST IOL Cutter Set DFH-0012, DFH 0019, and DFH-0028 Per Visit (8)

Zeiss Lumera Microscope Handle Set per Visit (8)

Utrata Forcep E2002 Per Visit (8)

PRN Extra Instruments (3 Sets)

.12 Forceps

Vannas Scissors

Cyclodialysis Spatula

Angled McPherson Tying Forcep

Straight McPherson Tying Forcep

Suture Set Trays

Wescott Scissor

Malyugin Ring Manipulator

Disposables

0 degree Phaco needle (1/patient)

30 degree Phaco needle (1/patient)

4.1.1. The cataract equipment must be mobile, and able to accommodate cataract surgery procedures.

4.1.2. The types of cataract surgical supplies required by the Altoona VAMC will include all such supplies as specified by each surgeon as he/she deemed necessary to perform cataract procedures. The surgeon’s specific equipment & case supplies are listed above.

4.1.3. It is expected that all requested equipment meet the inspection criteria of the Altoona VAMC’s Biomedical Department. Safety checks and PM records are to be up-to-date as required by the manufacturer and copies provided to the COR initially upon contract start up and as required thereafter.

4.1.4. The contractor should also acknowledge that the cataract surgery equipment is in good working condition and is regularly maintained. The contractor will be liable for damages should patient injury result due to equipment malfunction. The contractor must also indicate that sufficient insurance coverage is maintained for its contracted employees and for its equipment. The Contractor will maintain, for the term of this contract, fire and theft insurance coverage for the equipment. In addition, the Contractor will maintain, for the term of this agreement, general and professional liability insurance regarding their cataract services.

4.2. Duties of Contractor Personnel: The duties of the Surgical Technician/Coordinator are to set up the equipment and monitor the performance of the equipment during each surgical procedure making any adjustments as directed by the physician. In addition, the Surgical Technician/Coordinator assists the Altoona VAMC’s staff in staging supplies and turning the room between cases. The Surgical Technician/Coordinator will report directly to the operating physician while assisting with the surgical procedures. The Surgical Technician/Coordinator will function as the primary Scrub Technician for all cataract surgical procedures at the Altoona VAMC.

4.3. Orientation Session: An orientation session between the Altoona VAMC, the VA Physician, any designees, and the awarded contracted vendor will be scheduled prior to the first scheduled procedure date for cataract surgeries. This orientation/start-up process will include a day of preparation to review the cataract equipment, supplies, patient flow, and individual roles to include the following members: the VAMC’s Ophthalmologist, the VAMC’s Procedure Clinic Nursing staff, the vendor’s Surgical Technician and the vendor’s Contract Representative. The orientation date should be scheduled within two weeks of the contract awarded date.

4.4. Delivery Schedule:

4.4.1. On each scheduled surgical day, the contractor shall deliver the cataract equipment and disposables to the Altoona VAMC the day before the surgical procedure is scheduled. The Altoona VAMC shall afford the contractor with advance notice of the number of procedures to be performed for the purpose of providing supplies. Such advance notice shall be provided no later than four working days prior to the scheduled visit.

4.4.2. Instrument trays and any other equipment that require sterilization at the Altoona VAMC must arrive at a minimum 48 hours prior to surgical procedures. If cataract surgical procedures would be scheduled on a Monday, instrument trays and the equipment that require sterilization must arrive at the Altoona VAMC no later than Thursday before the scheduled procedure due to no weekend staffing in the Sterile Processing Service (SPS).

4.4.3. The Altoona SPS is requiring a minimum of eight (8) trays to be kept at the facility with additional trays correlating to the number of surgeries scheduled for that day, plus one (1) spare tray being available. In addition, two (2) sets of necessary emergency instruments should also be kept on-site.

4.4.4. The Altoona VAMC shall afford the contractor not less than 24 hours telephone notice of the time of the first procedure. In the event the VA’s surgeon is unable to arrive at the Altoona VAMC the day of scheduled procedures due to emergent situations, the contractor will be immediately notified and may remove the equipment from the Room. As an alternative, the party giving notice may request that the Altoona VAMC and the contractor adopt an alternative time. Due to the Altoona VAMC’s patient commitments and the contractor’s itinerary, the rights to cancel and to request a change may be exercised sparingly. The contractor may remove the cataract equipment at the conclusion of the last scheduled surgical procedure.

4.5. Medical Records:

4.5.1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

4.5.2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

4.5.3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4.5.4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

4.5.5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

4.5.6. The Government Agency owns the rights to all data/records produced as part of this contract.

4.5.7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

4.5.8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

4.5.9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

4.5.10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

4.6. Patient Safety Compliance and Reporting: Contractor’s personnel(s) shall follow all established patient safety and infection control standards of care. Contractor’s personnel shall make every effort to prevent medication errors, falls, and patient injury caused by acts of commission or omission in the delivery of care. All events related to patient injury, medication errors, and other breeches of patient safety shall be reported as soon as practicable (before leaving the Medical Center for the day). Contractors personnel shall notify the COR of incident and submit to the COR the Patient Safety Report, following up with COR as required or requested.

4.7. Patient Complaints: The CO and COR 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.

4.7.1. 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 conduct. The final arbiter on questions of acceptability is the CO.

5. GOVERNMENT RESPONSIBILITIES

5.1. The Altoona VAMC certifies that each surgeon designated by the VA to operate the cataract equipment is trained and competent in the use of that equipment in his or her surgical capacity. The Altoona VAMC maintains a facility adequate and suitable for the operation of the equipment. The Altoona VAMC 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 cataract equipment 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.

5.2. The Altoona VAMC shall provide a qualified and credentialed physician to perform all cataract surgeries.

5.3. The Altoona VAMC staff in the Sterile Processing Service (SPS) will be responsible for appropriate sterilization practices regarding all instrument trays and reusable medical equipment.

5.4. The Altoona VAMC will be responsible for providing necessary staff during procedures.

5.5. The Altoona VAMC will be responsible for providing patient care components for each cataract surgical procedure such as, but not limited to:

● Administering anesthesia and/or pharmaceuticals to include pre and post op eye drops as per ophthalmologist’s orders

● Administration of life-saving emergency services

● Provide IOL lens information to the Contractor prior to cataract surgery within one week prior to surgical date.

5.6. Three service days will be scheduled per month by the Altoona VAMC. Specific day(s) of service will occur during normal business hours and will be mutually agreed upon between the Altoona VAMC and the Contractor. The Altoona VAMC and the Contractor may negotiate additional days, if necessary. The Altoona VAMC shall afford the contractor not less than 24 hours telephone notice of the time of the first procedure. In the event the VA’s surgeon is unable to arrive at the Altoona VAMC the day of scheduled procedures due to emergent situations, the contractor will be immediately notified and may remove the equipment from the Room. As an alternative, the party giving notice may request that the Altoona VAMC and the contractor adopt an alternative time. Due to the Altoona VAMC’s patient commitments and the contractor’s itinerary, the rights to cancel and to request a change may be exercised sparingly. The contractor may remove the cataract equipment at the conclusion of the last scheduled surgical procedure.

5.7. The Altoona VAMC will supply the patient stretcher appropriate for cataract surgeries.

5.8. The Altoona VAMC’s Optometry Service, Nursing staff, or the designated surgeons shall assure that surgical consent forms have been received from all patients prior to the scheduled surgery.

5.9. During the term of this contract, the Altoona VAMC shall utilize the contractor’s equipment rental and outsourcing service for all cataract procedures.

5.10. 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).

5.10.1. CO RESPONSIBILITIES:

The Administering Contracting Officer for this contract will be Mark Knorr/ (570) 824-3521 x 7222 / Mark.Knorr@va.gov.

5.10.1.1. 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.

5.10.1.2. 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.

5.10.1.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include 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.

5.10.2. COR Responsibilities:

The COR for this contract is: Jessica Barnes, Senior COR / 814-943-8164 x7294 / Jessica.Barnes@va.gov.

5.10.2.1. 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 Contracting Officer.

5.10.2.2. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring.

5.10.2.3. The COR will maintain a record-keeping system of services.