Statement_of_Work_-_Medical_Equipment.pdf

STATEMENT OF WORK

AFGHANISTAN, MINISTRY OF INTERIOR (MoI)

MEDICAL EQUIPMENT SUPPLIES

26 August 2016

INTRODUCTION: The objective of this document is to define the requirements for selecting vendors to procure and deliver – and if necessary to install, service, and provide training for – medical equipment in partial fulfillment of the annual medical materiel requirement for the Afghan Ministry of Interior (MoI).

1. GENERAL REQUIREMENTS: Requirements for the goods or services reflected in these instructions are specified throughout the document; specific deliverables and performance measures are summarized in the table at paragraph 4. The vendor must be knowledgeable of and comply with applicable Afghan procurement and customs laws or regulations relevant to fulfilling these vendor instructions. As noted in paragraph 3.1, items requiring electrical power must be compatible with the electrical voltage provided in Afghanistan (European standard 220V). The medical equipment provided must meet or exceed the standards set forth in the World

Health Organization publication “Medical Device Regulations, Global Overview and Guiding Principles”. At a minimum, the provider of a given item will comply with (or have documented standards comparable with) the

Global Harmonization Task Force (GHTF) standards as set forth in the aforementioned guideline; a copy of the guideline can be obtained from the following address or website:

Marketing and Dissemination

World Health Organization

20 Avenue Appia

1211Geneva 27, Switzerland

Fax: +41 22 791 4857

Email: bookorders@who.int http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf

1.1. REQUIREMENT LIST: See Attachment 1 – Requirements List, MoI Medical Equipment

1.2. VENDOR QUALIFICATIONS: Vendor must be in compliance with Afghan regulation or law. The preferred vendor will have a documented history of providing medical materiel of acceptable quality in a timely fashion to Afghan military or government customers. The selected vendor must be able to procure and deliver the required quality and quantity of medical equipment within the specified timeframe. The ability to meet quality standards and delivery time are the most important factors for vendor selection.

1.3. DELIVERY INSTRUCTIONS: Vendor will satisfy the terms of this document within 90 days from the date the contract is awarded and in accordance with the delivery schedule outlined in paragraph 1.8.

1.4. METHOD OF PERFORMANCE: Vendor will utilize materials, equipment and work methods sufficient to successfully perform the terms and conditions of this document. Vendor will obtain stock levels of the medical equipment in quantities sufficient to ensure it can deliver the required amounts within the specified timeframe. Vendor will ensure delivery vehicles are equipped with the tools necessary (i.e. bolt cutters, wire cutters, etc.) to remove shipping container seals upon delivery. All medical equipment must be new, undamaged, in the manufacturer’s original packaging, and meet required electrical standards.

mailto:bookorders@who.int http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf

1.5. PRIMARY U.S. GOVERNMENT (USG) POINT OF CONTACT (POC):

Capt Shawn Banion

Headquarters Resolute Support (HQ RS)

Medical Institutional Advisory Team (MED IAT)

New Kabul Compound (NKC)

APO AE 09354

Email: shawn.banion@afghan.swa.army.mil

Phone: 318-449-3971 (DSN) or 070-281-2901 (Afghan Mobile)

1.6. ALTERNATE U.S. GOVERNMENT (USG) REPRESENTATIVES: With approval of the Contracting

Officer (KO), the primary USG POC may designate USG representatives from the HQ RS Medical Institutional

Advisory Team (MED IAT) to assist with coordinating and executing the contract terms and conditions.

1.7. DELIVERY LOCATION

ANPH - Afghan National Police Central Hospital

Ustad Rabbani Road (adjacent to Kabul Polytechnic University)

Kabul Province

Kabul, Afghanistan

Primary POC: ANPH Commander, Colonel Omar; Phone: 070-028-8716 email: omarfaiaz@hotmail.com

Alternate POC: OTSG Administrator, Dr. Samim; email: samim1st@gmail.com

1.8. DELIVERY SCHEDULE: Vendor will deliver 100% of all required line items no later than 90 days after acceptance of award (on or about 30 December 2016). Vendor will coordinate directly with the USG POC or his designated representative to schedule the actual delivery date and time in order to ensure that delivery vehicles are allowed passage through security check points.

1.9. DELIVERY COMMUNICATION / COORDINATION: Due to the uncertain security situation in

Afghanistan there is a high potential for schedule changes or delays. Also, advanced coordination may need to be conducted for equipment requiring installation and/or training. Therefore, it is essential for the primary USG

POC or his designated representative (henceforth known simply as USG POC) and the vendor to coordinate and communicate effectively prior to and during the delivery period to reduce or mitigate potential problems. To this end, within seven (7) days of contract award, vendor will provide a contact list of key personnel managing the delivery and/or installation. This contact list will include names with corresponding email addresses and phone numbers as well as after-hours and weekend contact information so USG POC can reach the vendor for urgent or time-sensitive matters. Vendor will respond to emails or phone calls from USG POC as soon as possible, but no later than 24 hours after the initial contact. Vendor will ensure the crew of every delivery vehicle is able to communicate by cell phone and will provide the USG POC with the crew contact information.

See paragraphs 3.2, 3.3, and 3.4 for additional detail on items requiring installation or training.

1.10. DELIVERY INSPECTION / INVENTORY: The USG POC must be present to accept delivery in conjunction with MoI personnel. For equipment not requiring installation and/or training, the USG POC will inventory, inspect for compliance and, if compliant, accept delivery. For equipment that requires installation and/or training, see paragraphs 3.2, 3.3, and 3.4 for additional details relating to acceptance by the USG POC.

Vendor will submit the invoice to the USG POC identified in paragraph 1.5 once the delivery is accepted. After acceptance, the USG POC will submit the vendor’s invoice together with a signed DD250 to the Afghanistan

Wide Area Workflow (WAWF) POC or KO for payment.

mailto:shawn.banion@afghan.swa.army.mil mailto:omarfaiaz@hotmail.com mailto:samim1st@gmail.com

2. STORAGE / HANDLING / SHIPPING REQUIREMENTS: All storage, handling, and shipping costs will be included in the price quoted. Vendor will ensure medical equipment items are stored and shipped in accordance with the manufacturer’s specifications. In particular, any specifications for temperature, humidity, or package orientation during storage and/or shipment of a given item must be strictly observed.

2.1. DEGREE OF PROTECTION: Vendor will use the amount and type of packaging and packing material to the degree necessary to preserve, protect or otherwise preclude damage to shipping containers and the contents thereof under normal shipping and handling conditions. The degree of protection will conform to standard commercial practices, applicable carrier regulations, and manufacturer’s specifications for shipment of the item or materiel from the provider to the receiving location(s) cited in the contract.

2.2. BIOHAZARDOUS ITEMS: Vendor will package and mark flammable, biohazardous and chemical materiel in accordance with industry standards and as required by applicable law. Such items will be shipped in separate containers that are appropriate to properly and safely store the material throughout shipment.

3. ADDITIONAL REQUIREMENTS / CONDITIONS / SPECIFICATIONS. Contractor will be required to provide the following:

- Set-up and installation of equipment upon delivery

- 12 Month Warranty on all equipment

- End-User initial training: The duration of the training program may vary depending on the operational complexity of the equipment, but the program will be no shorter than 1 hour and no longer than three months without submitting written justification to – and receiving permission from – the contracting officer (KO). The aforementioned notwithstanding, the vendor will train to a competency standard, not a time standard. If at the end of the contracted training program, the end-users are deemed not competent by the USG POC, vendor is required to continue training until competency is achieved.

3.1. ELECTRICAL REQUIREMENT: Vendor will ensure that medical equipment requiring a source of electrical power has an electrical safety certification (i.e. UL or CE rating) from the country of origin. Vendor will also ensure that medical equipment designed to utilize building / facility power outlets (whether for normal operation or to recharge batteries) are capable of operating on a 220 Volt system.

3.2. INSTALLATION / TRAINING COORDINATION MEETINGS: Depending on the nature of the equipment being delivered, it may require installation at the end-user facility and/or a training program for the end-users. Planning the installation equipment and/or the implementation of a training program will require coordination prior to delivery and throughout the installation and/or training process. To that end, for equipment requiring installation, vendor will conduct a site survey and coordination meeting at the end-user facility no less than 30 days before delivery. For equipment requiring training, vendor will develop and provide an electronic copy of a training program to the USG POC no less than 30 days before delivery. Additional coordination meetings to evaluate and/or discuss the progress of installation or training activities will be conducted as needed at the direction of the USG POC. Vendor will attend a final coordination meeting during which the USG POC and end-users will assess the installation and/or validate the competency of end-user trainees before accepting contract completion.

3.3. EQUIPMENT INSTALLATION: All medical equipment installation costs will be considered and included in the price quoted. Vendor will ensure that equipment is properly installed at the end-user facility, and that it is aesthetically and functionally integrated with the facility structure and/or utilities (i.e. electrical, plumbing, data network, etc.). Vendor is authorized to subcontract the installation if necessary, but vendor will retain responsibility for the timeliness and quality of the subcontractor’s work.

3.4. EQUIPMENT TRAINING: All medical equipment training costs will be considered and included in the price quoted. Regarding the training program described in paragraph 3.2, at a minimum the training program will specify and/or provide: the training curriculum and schedule; the materials and facilities needed to support training; the identity and qualifications of the trainer(s); and any life-support requirements needed for the trainer(s); transportation cost for trainee(s) from Kabul to the vendor approved training site for the following items.

CLIN #22: Endoscopic System - One Person

CLIN #27: Dental X-Ray Units - One Person

CLIN #28: Blood Chemistry Analyzer - Two Persons

CLIN #29: C-Arm X-Ray Unit - One Person

Vendor is authorized to subcontract the training program if necessary, but vendor will retain responsibility for the timeliness and quality of the subcontractor’s work. If completing the training program within the 180-day timeline is the only factor preventing contract acceptance, the KO may authorize an extension in consultation and concurrence with the USG POC.

The following items will require

3.5. EQUIPMENT WARRANTY / MANUALS: Vendor will ensure that any warranties assigned to the medical equipment procured for this contract are valid, current, and at full-strength at the time of delivery.

Vendor will ensure all warranty documents, instruction or operator manuals, and service or maintenance documents associated with the equipment are provided in both the English and Dari languages. Vendor will arrange document translation as needed and will take appropriate measures to ensure translations accurately convey technical and/or medical information as intended in the original language.

3.6. VARIATIONS / SUBSTITUTIONS: Only the Contracting Officer (KO) can authorize any variations or substitutions to the requirements, terms and conditions set forth in this contract. Vendor will not substitute a brand-named or generic product for the specified requirement without first obtaining permission from the KO.

3.7. U.S. GOVERNMENT-FURNISHED ITEMS / MATERIAL: If applicable, the USG POC will provide guidance for pre-installation site surveys and/or equipment training programs associated with the installation and/or implementation of the equipment. Said guidance will be provided either as part of the request for proposal process or during the pre-delivery coordination period.

3.8. VENDOR-FURNISHED ITEMS / MATERIAL: Vendor will furnish all personnel, labor, vehicles, fuel, tools, food, or any other items or material necessary to perform the services specified in this document.

3.9. VENDOR LIABILITY: Vendor will be held liable for any damage to the medical equipment caused by the vendor’s – or any subcontractor’s – failure to follow manufacturer specified shipping, handling, and installation procedures and/or by any negligent or careless acts on the part of the vendor or subcontractor.

4. TABLE of DELIVERABLES / PERFORMANCE MEASURES.

Table of Deliverables / Performance Measures – SY1395 Equipment Contracts

No. Deliverable Description Para. Performance Measure

1a

Ensure products meet quality standards.

Vendor selects provider that is able to document the quality of its products.

1, 1.2

Vendor provides documentation that provider complies with GHTF or comparable standards.

1b

Vendor utilizes sufficient degree of protection to ensure product quality is maintained.

1.4, 2, 2.1, 2.2

Results of product inspection upon delivery indicate compliance with contract specifications.

2a

Ensure on-time delivery of products.

Vendor has documented history of providing on-time service to

Afghan government / military customers.

1.2

Vendor provides proof of regulatory compliance and history of good local business practices as part of vendor bid and selection process.

2c

Vendor utilizes suitable amount and type of materials, vehicles and other work methods.

1.4, 2, 2.1, 2.2, 3.7

Vendor does not use poorly maintained or unsafe vehicles, or substandard materials and work methods that a reasonable person would expect to degrade delivery requirements.

2d

Vendor obtains sufficient stock to meet requirement and delivery schedule.

1.3, 1.4, 1.8, 1.10

Vendor delivers 100% of product, meeting specified requirements and in accordance with the delivery schedule.

3a

Ensure regular and effective communication.

Vendor provides contact list with names, email addresses, and cell phone numbers.

1.9

Vendor provides contact list to USG

POC within seven (7) days of contract award.

3b Vendor ensures delivery crew has cell phone.

1.9

Vendor provides USG POC with delivery crew contact information as part of the delivery coordination process.

3c

Vendor responds in a timely fashion to calls, emails, or other types of contact from the customer.

1.8, 1.9

Vendor responds to customer contact as soon as possible but no later than 24 hours after the customer’s initial attempt.

3d

Vendor is able to respond to customer concerns after-hours and weekends.

1.9

Contact list provided in Deliverable 3a includes after-hours and weekend contact information.

Meet electrical requirements.

Products delivered meet electrical safety and voltage requirements.

1, 1.4, 3.1

Results of product inspection upon delivery indicate compliance with contract specifications.

Meet installation requirements.

Products requiring installation are properly installed at and integrated with end-user site.

1.9, 3.2

Results of product inspection at end-user site indicate compliance with contract specifications.

Meet training requirements.

Provided program produces end-users competent to operate

/ maintain the equipment.

3.3

Results of product inspection at end-user site indicate compliance with contract specifications.

Meet warranty and document requirements.

Warranty and other documents are translated into Dari and provided to the end-user.

3.4

Results of product inspection upon delivery indicate compliance with contract specifications.