Draft Statement of Work.docx

STATEMENT OF WORK

SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following:

Delivery of Ear, Nose and Throat (ENT) Laryngoscopy Equipment. This equipment helps surgeons focus on critical anatomy during procedures in a wider range of patient anatomies and is designed for patients with a greater distance between their teeth and vocal cords. Additionally, the grasping and cup biopsy forceps have aggressive serrated jaws for better holding and a suction channel with proximal fitting for smoke evacuation and improved visibility during laser procedures.

This is a brand name requirement for Pilling products sold by Teleflex LLC..

1. EQUIPMENT

The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable.

This purchase or use of this equipment does not involve VA sensitive information/data.

The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation.

2. AREAS TO BE SERVICED

Department of Veterans Affairs VA Providence Healthcare System 830 Chalkstone Avenue Providence, RI 02908

3. SALIENT CHARACTERISTICS

ENT Laryngoscopy Equipment includes:

1. Pilling Micro Laryngoscopy Container (50SC06L01): Designed to hold a full set of laryngeal instruments including laryngoscopes, chest support, forceps, picks, and knives. Solid bottom container system. Three basket levels hold 6 laryngoscopes plus instruments and light cables. 27”X11”X6” with starter kit. Starter kit includes 40 disposable filters, 20 tamper evident seals, 20 load cards and 20 load indicator strips.

2. Pilling Dedo-Style Laser Laryngoscope (522221): Supplied with a single light carrier flush with the handle to accommodate the fiberopotic cable. Satin finish outside, matte finish inside and a smoke evacuation channel. Overall Length is 178 mm, Min I.D. is 10.7 mm, Nominal Proximal Dimensions are 19.0 mm x 19.0 mm, and Max O.D. is 25.5 mm.

3. Ossoff-Pilling Laryngoscope 19mm x17cm (522190): Adult Size with an overall length of 168 mm, Min I.D. of 7.0 mm, Nominal Proximal Dimensions of 19.0 x 15.0 mm, and Max O.D. of 22.0 mm. Narrow width to increase patient selection for micro procedures. Capable of absorbing both microscope sight lines. Can be used in most patients who previously could accept only the original Holinger scope. Standard adult handle can be used with most suspension systems. Supplied with one single light carrier and external tube dimensions are kept to a minimum.

4. Jako Laryngoscope Type 3 Adult (522206): Scope Size is adult, overall length of 178mm, Min I.D. is 13.4 mm, Nominal Proximal Dimensions is 29.0 x 20.0 mm, Max O.D. is 34.0 mm. Lighting system to divert the fiberoptic cable out of the way of the surgeon’s hands. A bifurcated light carrier running down each side of the laryngoscope barrel to minimize shadows from the instruments when approaching vocal cord lesions.

5. Jackson Str 4mm Cup Fcps 28cm (505100): Straight, 4 mm diameter jaw, working length 28 cm. Standard and extra lightweight construction provides durability and strength. The jaw size, shape and angle are specially calculated for use through Jackson scopes.

6. Jako Cup Forceps Straight (506455): Straight, 2.4 mm tip. Slender 2 mm diameter stems with miniature distal jaws in the shape of cup forceps. Dull finished stainless steel to reduce glare. Stems are angulated (5 degree bend at handle) for unobstructed vision and all have a 22 cm working length.

7. Jako Cup Forceps Angled Up (506462): Angled up. Slender 2 mm diameter stems with miniature distal jaws in the shape of cup forceps. Dull finished stainless steel to reduce glare. Stems are angulated (5 degree bend at handle) for unobstructed vision and all have a 22 cm working length.

8. Jako Scissors Curved Left (506475): Curved left. Slender 2 mm diameter stems with miniature distal jaws in the shape of scissors. Dull finished stainless steel to reduce glare. Stems are angulated (5 degree bend at handle) for unobstructed vision and all have a 22 cm working length.

9. Jako Scissors Curved Right (506476): Curved right. Slender 2 mm diameter stems with miniature distal jaws in the shape of scissors. Dull finished stainless steel to reduce glare. Stems are angulated (5 degree bend at handle) for unobstructed vision and all have a 22 cm working length.

10. Phono Sickle Knife Curved (506882): Curved sickle and 27 cm maximum working length, 3mm blade and a 3.2 – 1 mm tapered shaft. Working length is measured from front portion of handle to tip of instrument.

11. Micro-Laryn Forceps Trian Jaw, Right (506950): A serrated triangular jaw for grasping a larger surface area of tissue within the 3 mm wide tips. Working length of 23.5 cm and a non-reflective finish for use with lasers. Jaws are angled and perforated along the surface of the respective chord, 2.75 mm wide triangular jaw, serrated jaw, 2 mm shaft. Fits adult laryngoscopes without interfering with microscope, 5 degree bend at the handle. Right.

12. Micro-Laryn Forceps Trian Jaw, Left (506952): A serrated triangular jaw for grasping a larger surface area of tissue within the 3 mm wide tips. Working length of 23.5 cm and a non-reflective finish for use with lasers. Jaws are angled and perforated along the surface of the respective chord, 2.75 mm wide triangular jaw, serrated jaw, 2 mm shaft. Fits adult laryngoscopes without interfering with microscope, 5 degree bend at the handle. Left.

13. Aspirating Tube Open End 20cm (507010): Constructed of stainless steel. They are measured in working length from distal tip to beginning of proximal curve or angle. Aspirating tubes should be 5 cm or 10 cm longer than the scope. Working length for use thru scopes tube diameter is 20 cm, 5.0 mm or larger and 4 mm (12 Fr.)

14. Tobey Laryngoscope Holder (502248): A quick attach/release mechanism to allow a secure hold of the laryngoscope that eliminates twisting and turning. A size adjustment knob for other laryngoscope handles. Enables the surgeon to perform surgery requiring both hands for instrument insertion through the laryngoscopes .

The Contractor shall provide a fully functional system that meets the following characteristics:

a) ENT surgical instruments designed to perform specific functions, such as cutting, grasping, clamping, dissecting, probing, retracting, draining, aspirating and suturing. The laryngoscopes should allow distal expansion of the lower blade for maximum visibility of the cords and other areas beyond the cords.

b) Non-reflective internal surface to minimize laser beam deflection.

c) Removable handle could be attached to the standard laryngoscope holder, the Tobey Laryngoscope Holder (Item 502248 above), or the Boston University System.

d) Laryngoscopes have permanently attached smoke evacuation channel capable of extending distally for maximum removal of laser plume.

e) A Warranty to include all surgical instruments shall be free from manufacturing defects in material or workmanship for the life of the instrument. Teleflex Medical's sole responsibility under all the warranty shall be, at Teleflex Medical's option, to either repair, replace, or refurbish any instrument proving defective, free of charge. Pilling instruments that feature the Life-Lok box lock are warranted not to break or crack in the box lock area due to stress buildup for the life of the instrument.

4. INSTALLATION

a) The Contractor shall provide all labor, materials, tools, equipment and etc. to prepare for and complete the installation of the equipment in the space determined by the Government.

b) Project implementation meetings, if necessary, shall be coordinated with the COR.

c) Installation and implementation dates are to be coordinated in advance with the Contractor and the COR.

d) All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access.

e) All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government.

f) All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work.

g) The Contractor shall communicate to the Government the estimated downtime required to complete full installation and testing AIO computer. If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment.

h) The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable.

i) The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation.

4. TRAINING

None. Personnel are familiar with the equipment.

5. INSPECTION AND ACCEPTANCE

a) The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

b) Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

c) The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. WARRANTY

a) The contractor shall provide a manufacturer’s warranty on all parts and labor.

b) The warranty shall include all travel and shipping costs associated with any warranty repair.

7. TASK FREQUENCY AND INSTRUCTIONS

The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR.

Equipment delivery shall not preceed installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including “go live” support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award.

8. SPECIAL WORK REQUIREMENTS

The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work.

The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work.

9. PROPERTY DAMAGE

The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, cubs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer.

10. ATTACHMENTS

None.

11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS

The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD

The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall:

a) Have methods by which all employees are educated as to risks associated with blood borne pathogens.

b) Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens.

c) Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens.

d) Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract.

13. INFORMATION SECURITY LANGUAGE

None.

14. RECORDS MANAGEMENT LANGUAGE FOR STATEMENT OF WORK (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

a) Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 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.

b) 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.

c) 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.

d) 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.

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

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

g) 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.

h) 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.].

i) 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.

j) 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.